[Senate Hearing 115-438]
[From the U.S. Government Publishing Office]
S. Hrg. 115-438
NOMINATION OF ALEX MICHAEL AZAR II
=======================================================================
HEARING
before the
COMMITTEE ON FINANCE
UNITED STATES SENATE
ONE HUNDRED FIFTEENTH CONGRESS
SECOND SESSION
on the
NOMINATION OF
ALEX MICHAEL AZAR II, TO BE SECRETARY,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
__________
JANUARY 9, 2018
__________
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
__________
Printed for the use of the Committee on Finance
__________
U.S. GOVERNMENT PUBLISHING OFFICE
34-341-PDF WASHINGTON : 2019
COMMITTEE ON FINANCE
ORRIN G. HATCH, Utah, Chairman
CHUCK GRASSLEY, Iowa RON WYDEN, Oregon
MIKE CRAPO, Idaho DEBBIE STABENOW, Michigan
PAT ROBERTS, Kansas MARIA CANTWELL, Washington
MICHAEL B. ENZI, Wyoming BILL NELSON, Florida
JOHN CORNYN, Texas ROBERT MENENDEZ, New Jersey
JOHN THUNE, South Dakota THOMAS R. CARPER, Delaware
RICHARD BURR, North Carolina BENJAMIN L. CARDIN, Maryland
JOHNNY ISAKSON, Georgia SHERROD BROWN, Ohio
ROB PORTMAN, Ohio MICHAEL F. BENNET, Colorado
PATRICK J. TOOMEY, Pennsylvania ROBERT P. CASEY, Jr., Pennsylvania
DEAN HELLER, Nevada MARK R. WARNER, Virginia
TIM SCOTT, South Carolina CLAIRE McCASKILL, Missouri
BILL CASSIDY, Louisiana
A. Jay Khosla, Staff Director
Joshua Sheinkman, Democratic Staff Director
(ii)
C O N T E N T S
----------
OPENING STATEMENTS
Page
Hatch, Hon. Orrin G., a U.S. Senator from Utah, chairman,
Committee on Finance........................................... 1
Wyden, Hon. Ron, a U.S. Senator from Oregon...................... 4
WITNESSES
Thompson, Hon. Tommy, former Secretary, Department of Health and
Human Services, Washington, DC................................. 7
Leavitt, Hon. Michael, former Secretary, Department of Health and
Human Services, Washington, DC................................. 8
ADMINISTRATION NOMINEE
Azar, Hon. Alex Michael, II, nominated to be Secretary,
Department of Health and Human Services, Washington, DC........ 10
ALPHABETICAL LISTING AND APPENDIX MATERIAL
Azar, Hon. Alex Michael, II:
Testimony.................................................... 10
Prepared statement........................................... 51
Biographical information..................................... 52
Responses to questions from committee members................ 64
Grassley, Hon. Chuck:
Submissions for the record................................... 162
Hatch, Hon. Orrin G.:
Opening statement............................................ 1
Prepared statement........................................... 167
Leavitt, Hon. Michael:
Testimony.................................................... 8
Thompson, Hon. Tommy:
Testimony.................................................... 7
Wyden, Hon. Ron:
Opening statement............................................ 4
Prepared statement with attachments.......................... 168
Communications
The AIDS Institute............................................... 193
AIDS United...................................................... 193
Bassuk Center on Homeless and Vulnerable Children and Youth, et
al............................................................. 194
Ernst, Alison Michelle........................................... 196
Hansa Center for Optimum Health.................................. 197
(iii)
NOMINATION OF ALEX MICHAEL AZAR II,
TO BE SECRETARY, DEPARTMENT OF
HEALTH AND HUMAN SERVICES
----------
TUESDAY, JANUARY 9, 2018
U.S. Senate,
Committee on Finance,
Washington, DC.
The hearing was convened, pursuant to notice, at 10:02
a.m., in room SD-215, Dirksen Senate Office Building, Hon.
Orrin G. Hatch (chairman of the committee) presiding.
Present: Senators Grassley, Enzi, Cornyn, Thune, Burr,
Portman, Heller, Scott, Wyden, Stabenow, Cantwell, Nelson,
Menendez, Carper, Cardin, Brown, Bennet, Casey, Warner, and
McCaskill.
Also present: Republican staff: Chris Armstrong, Chief
Oversight Counsel; Jennifer Kuskowski, Chief Health Policy
Advisor; and Caitlin Soto, Oversight Counsel. Democratic staff:
Joshua Sheinkman, Staff Director; Laura Berntsen, Senior
Advisor for Health and Human Services; Anne Dwyer, Health-care
Counsel; Peter Gartrell, Investigator; Elizabeth Jurinka, Chief
Health Advisor; and Matt Kazan, Health Policy Advisor.
OPENING STATEMENT OF HON. ORRIN G. HATCH, A U.S. SENATOR FROM
UTAH, CHAIRMAN, COMMITTEE ON FINANCE
The Chairman. The committee will come to order. Welcome,
everybody, to this morning's hearing.
Today the committee will consider and examine the
nomination of Mr. Alex Azar to serve as the Secretary of Health
and Human Services, one of the most important jobs in any
government, anywhere in the world.
I would like to welcome Mr. Azar to the Finance Committee
this morning. I want to thank you for being here and for your
willingness to serve in this important capacity.
Mr. Azar certainly has his work cut out for him. Health and
Human Services is a massive, sprawling department that oversees
trillions of dollars in spending and liabilities and
encompasses all areas of our Nation's health-care system. As a
result, if confirmed, Mr. Azar's work will impact the lives of
every single American.
Now, that is a big job. It requires knowledge, experience,
and, most important, strong leadership. Fortunately, our
nominee brings all of this to the table, having nearly 2
decades of experience in the health-care sector, including
about 6 years working at the highest levels of HHS.
During his time at HHS, Mr. Azar played key roles in
implementing new policies, including Medicare Part D and the
Medicare Advantage program. He was also a leader in HHS's
responses to the anthrax attacks shortly after 9/11, the SARS
and monkeypox crises, and Hurricane Katrina, just to mention a
few.
If confirmed, Mr. Azar will be Congress's primary contact
on all matters relating to our Nation's health-care system. He
will be responsible for the ongoing efforts to bring down
costs, provide greater access to care, and give patients more
choices when it comes to coverage.
Whether we are talking about work to modernize Federal
health programs like Medicare and Medicaid in order to preserve
them for future generations, innovating the CHIP program, or
reforming the private market, Mr. Azar will be the
administration's primary policy driver.
He has made clear his intentions to address the growing
opioid epidemic that continues to ravage communities across the
country, including in my home State of Utah. This crisis is
robbing families of loved ones, employers of productive and
able workers, and communities of the safety and security they
once enjoyed.
Now this is an important issue to everybody on this
committee, but in particular to me and other members of the
committee. I look forward to working with Mr. Azar to figure
out how HHS and CMS can make improvements to save lives.
As many know, I co-authored the Ensuring Patient Access and
Effective Drug Enforcement Act, which has recently come under
scrutiny in relation to the opioid epidemic. This law requires
HHS to submit a report to Congress regarding obstacles to
legitimate patient access to controlled substances and issues
with diversion of controlled substances.
The required report is long overdue, and so, today, I would
like to impress upon Mr. Azar the importance of getting this
report to Congress so that we can have an opportunity to review
and make any necessary changes to the law that may help to turn
the tide of this epidemic. I hope to get his commitment to
produce and release this report as soon as possible, once he is
confirmed.
He has expressed his commitment to succeeding in these
important endeavors, and I believe his record shows that he is
more than capable of leading HHS through these next few
consequential years.
Of course, there are some on the committee who have already
made up their mind about Mr. Azar and are committed to opposing
his nomination. This is essentially par for the course for the
high-profile nominees that have come before us under this
administration.
And, as in previous cases, none of the attacks leveled at
Mr. Azar is focused on his record, his experience, or his
qualifications. Instead, we are hearing talk about supposedly
revolving doors and non-existing conflicts of interests.
While I believe Mr. Azar is more than capable of responding
to his critics on his own, I would like to take just a moment
to address some of the more prominent attacks we have heard
thus far.
Opponents of this nomination have claimed Mr. Azar's work
in the pharmaceutical industry, where he has been a senior
executive for the past 10 years, disqualifies him to serve in
this position.
I would hope that my colleagues would want to avoid
creating standards or setting new precedents where work in the
private sector is somehow a knock against a nominee. That
certainly was not the standard they applied to nominees from
the previous administration, and it should not apply to this
one.
Mr. Azar has committed to fully adhering to all necessary
ethics requirements, including the Trump administration's
requirement prohibiting nominees from participating in matters
involving their former employers and clients for 2 years after
the end of their government service. In addition, he has
committed to divesting any financial holdings that could
present a conflict of interest or even the appearance of such a
conflict.
So, we are not talking about anything unethical. We are not
talking about a nominee attempting to unduly profit off his
government position.
Experience in the private sector in dealing with the
policies and regulations that come from government agencies
is--in my view--a mark in favor of a nominee's qualifications.
Mr. Azar's work in the pharmaceutical industry will give him
important insights regarding the impact of policies designed
and implemented by HHS. And, when you add that knowledge and
background to the years he spent as a senior official at HHS,
you have an extraordinary resume for an HHS Secretary.
Once again, I believe Mr. Azar is more than capable of
responding to what have so far been empty criticisms. By any
objective standard, Mr. Azar is well-qualified to serve as
Secretary of HHS. My hope is that we can have a highly
productive hearing today and report his nomination in short
order.
I want to thank you, once again, Mr. Azar, for being
willing to go through this and to appear here today. And I want
to thank you, again, for returning to the call to serve the
American people. I personally look forward to your testimony.
Now, before turning to Senator Wyden, I would like to
reemphasize my support for the Children's Health Insurance
Program and my commitment to making sure it gets reauthorized.
It is one of the most important programs that I worked on and
got through--of course, with the help of Senator Kennedy and
others.
We have a bipartisan agreement that was reported out of
committee, and I believe it improves CHIP for the long term.
Congress has passed patches and fixes, but the time for short-
term solutions is over. CHIP needs to be extended by January
19th, and I am going to do all I can to make sure we get it
done. Children, their families, and States are counting on us.
[The prepared statement of Chairman Hatch appears in the
appendix.]
The Chairman. With that, now I will turn to my good
companion, Senator Wyden.
OPENING STATEMENT OF HON. RON WYDEN,
A U.S. SENATOR FROM OREGON
Senator Wyden. Thank you very much, Mr. Chairman. I very
much appreciate your convening the hearing.
Colleagues, this is the first time we have been together
since Chairman Hatch has announced his retirement. And I would
just like to take a moment--because we talked on the phone--to
say publicly what I mentioned to you.
First, you have always been a gentleman. Every member of
this body feels that. We know about your passion. We know about
your dedication. We know about the fact that you have always
had an ear for your colleagues.
Often when you and I talk, you say, ``What are my
Democratic friends up to? Who should I be listening to?''
Always there with an ear, and I would just like to note
something I do not think everybody knows, but Chairman Hatch
was a boxer. And basketball players know a little bit about
endurance, but, colleagues, just picture 40 years in the ring,
40 years a boxer. That is real endurance.
So I am sure we are going to have other colleagues talk at
greater length, but since this is the first time we have
actually been together publicly, Mr. Chairman, I just wanted to
note that.
I also appreciate the fact that you mentioned CHIP. As you
know, we have teamed up on this now for quite some time. I
would like to think that the fact that we came out of the gate
early, moved the House--they did not follow all of our
approaches to being bipartisan, particularly as it came to
revenue. But I think we all understand that we have to get this
done, and we have to get it done quickly.
And the American people said to me during the break--what
happened at the end of the year is, the kids got a patch. And
if you were powerful, you ran a multinational corporation, you
got permanent relief. We are better than that.
Mr. Chairman, I just want to say, I am looking forward to
working closely with you. We have virtual unanimity in this
committee with respect to CHIP. And getting this across the
finish line and ensuring that families across this country do
not go to bed at night in near panic about the prospect of an
emergency illness the next day is critical. So I look forward
to working with you on that.
Now to today's business. The same Donald Trump who said
almost exactly a year ago that price-hiking drug companies were
getting away with murder has nominated a drug company executive
with a documented history of raising prescription drug prices.
Mr. Alex Azar is here before the committee, nominated to serve
as the next Secretary of Health and Human Services.
It is my view that the issues he will work on, if
confirmed, are going to be defining domestic issues in 2018.
That is because the American people heard a lot of promises
2 years ago about how great their health care would be under a
President Trump, and how the era of skyrocketing drug prices
was over. Americans are going to want to know, come this
November, if all those big promises, if all those big pledges
they heard in the fall of 2016, actually happened. To say the
administration has not yet delivered would be a wild
understatement.
Now, Mr. Azar was the president of Eli Lilly's U.S.-based
subsidiary, Lilly USA, from 2012 to 2017. He chaired its U.S.
pricing, reimbursement, and access steering committee, which
gave him a major role over drug price increases for every
product Lilly marketed in the United States.
Now, Chairman Hatch suggested--and I appreciate him doing
this, because he and I talked about this--focusing on the
record, the public record. So our staff has done a fair amount
of homework on it, and I want to spend some time looking at the
track record.
The price of Lilly's bone-growth drug Forteo, used to treat
osteoporosis, more than doubled on Mr. Azar's watch. The price
of Effient, used to treat heart disease, more than doubled. The
price of Strattera, used to treat ADHD, more than doubled. The
price of Humalog, used to treat diabetes, more than doubled.
These are just some of the drugs that were under Mr. Azar's
purview as head of Lilly USA.
Significantly, Mr. Azar told the committee staff that while
he chaired the company's pricing committee he never--not even
once--signed off on a decrease in the price of a drug.
Now, this morning the committee--in my view--is likely to
hear from Mr. Azar and colleagues that this is the way things
work. It is the system that is at fault. It is the system that
ought to be blamed.
My view is, there is a fair amount of validity in that. The
system is broken. Mr. Azar was part of that system. Given ample
opportunity to provide specific examples as a nominee of how he
would fix it, Mr. Azar has come up empty.
If Mr. Azar is confirmed, it will not be the first time the
President and his health-care team broke their promises. A
virtual parade of Trump health-care officials have come before
this committee and the HELP Committee and promised to uphold
the law with respect to the Affordable Care Act.
Right out of the gate, we remember Tom Price telling us it
would be his job to administer the law--administer the law at
HHS, not be a legislator. The track record does not look so
great there, because in effect, on Day 1 it sure seems that the
sabotage policy kicked in.
Along with allies in Congress, the Trump team wasted no
time undermining private health insurance markets. They cut the
open enrollment period in half. Advertising budgets were
slashed. It became harder for people having difficulty signing
up for coverage to get in-person assistance. They attacked a
rule that says women have to have guaranteed no-cost access to
contraception, but fortunately that has been a move that has
not been held up in the courts.
And what has been particularly troubling to me, because it
goes back to my days when I was director of the Gray Panthers,
the administration made it easier to sell junk insurance that
fails people when they have a health emergency. All in all, the
Trump administration has made millions of people's health care
worse, and there does not seem to be a serious plan to undo the
damage.
Mr. Azar will have to explain today whether he is going to
continue that policy. We talked about it in the office
yesterday. And he should, because it stands in stark contrast
to what Mr. Azar did when he was a member of the Bush
administration to help launch Medicare Part D. He was part of a
bus roadshow, public events, and local media appearances.
So, when it came to promoting the Medicare prescription
drug benefit--and I was one of the Democrats who voted for it--
he toured like he was in the Grateful Dead. Now he is set to
join an administration that has tweeted less about open
enrollment than about Thanksgiving safety.
Finally, there has been a lot of talk about welfare reform
coming up. Mr. Azar told me he believes Medicaid counts as
welfare. But everybody you ask seems to have a different answer
for what exactly ``welfare reform'' means.
The common thread to the Republican talk here is pretty
obvious: substantial draconian cuts to programs that are
lifelines--Medicare, Medicaid, Social Security, anti-hunger
programs, and support for struggling families. With respect to
Medicaid, for millions this program is at the heart of health
care in America, and it spans generations, from newborns to two
out of three older people in nursing homes.
Today, Medicaid is built on a guarantee. The Trump team
says it wants to end that. Those are public statements: end it.
They have set into motion plans that would make it harder for a
lot of people to get the care they need. In some cases it is
older people, sometimes it is folks with disabilities who need
long-term care. In other cases it is adults of limited means--
people who struggle to climb the economic ladder. That is kind
of my background, so I am interested in hearing what Mr. Azar
has in mind with respect to seniors.
To me, risking the Medicaid guarantee so essential for
long-term care for the eligible seniors--I want everybody to
know that is a non-starter here. Furthermore, my view is, you
cannot get ahead in life if you do not have your health, so
endangering the health of low-income Americans, in my view, is
the absolute wrong way to go.
So there are going to be other issues that fall under the
welfare umbrella. Mr. Azar has no experience in those areas. I
am one who feels that people with business backgrounds, those
viewpoints can be welcome, but they have to be combined with a
set of values that is in line with what I believe are the real
priorities for the American people.
So that is my sense of where we are, and I would like to
wrap up this way, Mr. Chairman. The leaders on both sides of
this committee previously had regular meetings and calls with
sitting HHS Secretaries. I see Mr. Leavitt, who went out of his
way when he was Secretary to have those kinds of meetings, and
Sylvia Burwell, and a whole host of Democratic Secretaries, did
the same thing.
I would like to just note, as we wrap up, that in my
meeting with Mr. Azar yesterday he noted that he was not going
to go along with the last HHS Secretary who broke that
bipartisan tradition to the detriment of the Senate and, in my
view, good policy. Mr. Azar, without any prompting, said that
he was interested in having those kinds of meetings, that he
would revive it.
So, Mr. Azar, thank you for being here. Thank you for our
meeting yesterday. We look forward to your statements and
questions.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator.
[The prepared statement of Senator Wyden appears in the
appendix.]
The Chairman. Here to introduce Mr. Azar are two
distinguished former Secretaries of Health and Human Services.
We will first hear from former Secretary Thompson. It is
really great to see you again. It has been quite a while since
I have seen you. We had a lot to do with each other way back
when.
He served as the head of HHS from 2001 to 2005. Prior to
that time, he served 4 terms as the Governor of Wisconsin, the
longest tenure of anybody in that State's history.
As Governor, he was a pioneer in a number of initiatives,
including welfare reform, which gained national prominence. As
the Secretary of HHS, he oversaw the passage and initial
implementation of Medicare Part D and led the Department
through the aftermath of September 11, 2001.
Next we are going to hear from a very personal friend of
mine--both are friends--we will hear an introduction from my
good friend, former Secretary Michael Leavitt, who headed HHS
from 2005 to 2009. Before that, Mike served as the
Administrator of the Environmental Protection Agency for 2
years and as Governor of Utah for almost a decade.
As Governor, he presided over some very prosperous times
for our State and held a number of national leadership
positions. As Secretary of HHS, he sounded the alarm about
Medicare's long-term fiscal difficulties.
Both Secretary Thompson and Secretary Leavitt are well-
respected public servants. Their opinions should carry quite a
bit of weight around here. I know they mean a lot to me, I will
tell you that.
I want to thank you both for being here today to speak on
behalf of the President's nomination of Mr. Azar. We will start
with Secretary Thompson, and then we will hear from Secretary
Leavitt.
Secretary Thompson?
STATEMENT OF HON. TOMMY THOMPSON, FORMER SECRETARY, DEPARTMENT
OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Secretary Thompson. Thank you very much, Chairman Hatch,
Ranking Senator Wyden, and the distinguished members of this
committee. I first want to thank you for this opportunity to
appear before you this morning. Before I start, I would like to
echo something that Senator Wyden said.
Mr. Chairman, you have always been a friend, a
distinguished member, a mentor to me personally, and always a
great leader, and I feel that today's meeting is somewhat
bittersweet for me. Sweet so that I can be here to endorse my
colleague; bitter to find out that you are leaving this august
body. Thank you for your service to our country, and thank you
for being my friend.
The Chairman. Well, thank you.
Secretary Thompson. I could not be more pleased or prouder
to introduce my friend and former colleague, Alex Azar. As the
President's nominee to be the next Secretary of Health and
Human Services, Alex is an outstanding individual with a great
family. His wife Jennifer, his two children, are both here as
well as his father Alex.
And I am here to provide my strongest personal endorsement
and to tell you that he has the capacity, the capability, the
intellect to be an incredible Secretary.
If confirmed, Alex will serve our Nation honorably and
competently. As I am sure you know, Alex has impeccable
academic credentials, including having graduated from Dartmouth
College and Yale Law School. The only thing I have against him
is that he did not go to the University of Wisconsin.
He has also clerked for Justice Antonin Scalia on the
United States Supreme Court. I was privileged to have him as my
General Counsel when I had the honor of serving as HHS
Secretary under George W. Bush.
Alex was an excellent General Counsel who developed a deep
understanding of HHS, its mission, and has respect for the
rules and laws that regulate and govern these programs. As a
result, he deeply respected and passionately was respected by
the career civil servants with whom he worked and led.
From his tenure as General Counsel, he went on to serve as
Deputy Secretary of HHS, further deepening his experience with
the understanding of his department, its important
responsibilities, and its world-class employees. And most
recently, he successfully led a large and important health-care
company in this country.
But the basis of my recommendation is not just Alex's
intellect, his leadership experience, or the deep understanding
of the department which he might lead. One of the most
important attributes of Alex Azar is his character. I know from
personal experience that he is very honest, dedicated,
passionate, and trustworthy. He says what he means, and he
means what he says. He is quite simply a man of great
integrity.
If the United States Senate were to confirm him, the
members of this great committee would have a thoughtful partner
who truly understands the complexity of our health-care system
and human services programs and knows how to get things done at
the Department of HHS. Further I believe, because he wants to
take on these challenges, he would work collaboratively with
you and would passionately articulate and carry out your wishes
and with you try and find the solutions to the pressing health-
care problems and find ways to improve it for our great
country. If Alex says he will do it, I can assure you that he
will.
Mr. Chairman, and all members of this committee, thank you
for giving me this opportunity to help introduce Alex Azar.
The Chairman. Well, thank you. Those words are very, very
strong and very good.
Secretary Leavitt?
STATEMENT OF HON. MICHAEL LEAVITT, FORMER SECRETARY, DEPARTMENT
OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Secretary Leavitt. Chairman Hatch, Senator Wyden, and
members of the committee, I join with my colleagues in
expressing gratitude and appreciation for your friendship,
Senator, and look forward to the coming year and all that you
accomplish.
I join as well today with Secretary Thompson and want to be
completely associated with his comments about Alex Azar. I too
unequivocally recommend that he be confirmed as the 24th
Secretary of the Department of Health and Human Services. He is
supremely qualified for that purpose, and he will carry out
that duty with fidelity.
I too, along with Secretary Thompson, feel well-equipped to
be able to offer an evaluation of Alex Azar. Alex was General
Counsel when I became Secretary, but subsequently he was
confirmed by the Senate of the United States as Deputy
Secretary of HHS.
As has been related, HHS is a large, very complex Federal
agency. It not only looks after administering the Nation's
health-care system, but it also looks after all of the human
services that we jointly as a country provide.
HHS oversees the Nation's public health system and much of
the national, medical, and scientific research. It carries out
a significant set of responsibilities related to disaster
recovery, as well as representing the United States of America
in various matters around the world.
As Deputy Secretary, Mr. Azar functioned essentially as the
Chief Operating Officer of the Department. I delegated much of
the day-to-day operation to his supervision. In that role, he
demonstrated the skill as a collaborative leader. I will cite
an example.
President Bush had a management agenda to improve the
efficiency of the Federal Government. They had developed a
series, almost three dozen different areas, of evaluations that
were to be graded on a chart that had green, yellow, and red.
Mr. Azar set a goal to have HHS become the first department
in the Federal Government to have every measure green. He
organized an effort among HHS's 27 operating centers, and he
met that goal--the first.
I am also witness that Mr. Azar is a man of good judgment.
As Secretary, I delegated oversight of the Department's
administrative rulemaking responsibility. In a very lawyerly
and impartial way, he oversaw the rulemaking process and made
recommendations to me as Secretary that I learned to have great
confidence in. He is a man of good judgment.
I have seen Mr. Azar under fire. It has been referenced
before: he is a steady leader in crisis. There was a period
during my service when we were managing the recovery from
Hurricane Katrina. We were preparing for what appeared to be a
potential pandemic influenza, and we were implementing Medicare
Part D all at the same time. Mr. Azar was measured, yet he was
responsible. He established priorities, and he accepted
responsibility.
Should you choose to confirm Mr. Azar, I want to assure you
that you will find him as I did, as an effective communicator.
I believe you will see bipartisan communication from Mr. Azar.
It is his way. He is a world-class policy leader, a policy
thinker. He is a person who brings unique experience from the
private sector, something that I believe will be of immense
importance over the course of the next years.
And lastly, I will close with two final observations. The
first is Alex Azar, by my experience, is a very good person.
And he is a man of compassion, which is an attribute, in my
judgment, that is critical in carrying out the important
mission of HHS.
Based on his previous experiences, I do not know that there
is a person who has ever been nominated as Secretary of Health
who is in a position to hit the ground running like Alex Azar.
He will serve the people of the United States well.
Thank you, Mr. Chairman.
The Chairman. Thank you both very much.
That is high praise, indeed, Mr. Azar. And we will turn to
you right now.
And we are grateful to the two of you for showing up here
today and helping us to understand this even further.
I have had a long experience with Mr. Azar. I could not
have a higher opinion than I have right now. And I am just
very, very pleased that he has had this nomination.
We will turn to you, Mr. Azar, for your comments.
STATEMENT OF HON. ALEX MICHAEL AZAR II, NOMINATED TO BE
SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES, WASHINGTON,
DC
Mr. Azar. Thank you very much, Mr. Chairman. If you would
not mind, I would like to introduce my family who are here
today.
I am joined today by my wife Jennifer, my daughter Claire,
and my son Alex, as well as my father Dr. Alex Azar, my sister
Stacey, and her husband Mick. Unfortunately my mother, Lynda,
could not be here today, and most tragically my step-mother
Wilma passed away just last July from cancer. Thank you all to
my family members. Having an opportunity such as this simply
does not happen without family support and guidance, as all of
you know personally, I am sure.
Mr. Chairman, Ranking Member Wyden, and members of the
committee, thank you for the opportunity to appear before you
as the President's nominee to be the Secretary of Health and
Human Services.
I cannot tell you how touched I am to hear the words of
Secretary Thompson and Secretary Leavitt. Thank you both so
much for those kind words and for your friendship and
mentorship over the last 20 years. I simply cannot think of two
gentlemen from whom I have learned more professionally and
personally in terms of leadership than the two of you, and it
just means so much to be sitting here with you. I never thought
that day would happen. Thank you.
I also thank President Trump for the confidence that he has
bestowed on me in nominating me for this awesome
responsibility.
Ninety-seven years ago, my grandfather, an impoverished
teenager who spoke not a word of English, stepped out of
steerage on the S.S. Argentina, completing his long journey
from Amioun, Lebanon to America. As he entered the receiving
hall of Ellis Island, he met an individual who was wearing a
military uniform.
That person possessed the power to admit him or to send him
back to poverty and uncertainty. That person was a member of
the United States Public Health Service.
It is a testament to all that I love about this country
that just 97 years after my grandfather went through his 6-
second physical on Ellis Island with no discernable prospects
other than the political, economic, and religious freedom that
America offers, his grandson might be in charge of that very
same Public Health Service, as well as all of the other world-
renowned components of the Department of Health and Human
Services.
The mission of HHS is to enhance and protect the health and
well-being of all Americans, through programs that touch every
single American in some way every single day. Through its
outstanding leaders and career staff, HHS is primed to meet
that challenge. The task is humbling, I will say.
Marshaling and leading the incredible resources of the
Department require innovating, never being satisfied with the
status quo, and anticipating and preparing for the future. I
hope I gained these skills in the dark days after 9/11, as we
faced the health and human consequences of those attacks;
through the subsequent anthrax attacks and preparedness for
potential further biological, chemical, radiological, or
nuclear attacks; in the implementation of our completely novel
Part D prescription drug benefit for seniors; by helping to
build global, national, State, and local pandemic flu
preparedness in our response to threats such as SARS and
monkeypox; in our efforts to continue to reform welfare
programs to make them as modern, responsive, and empowering as
possible for the individuals and families that we serve;
through innovation in the private sector to bring life-
improving therapies to our people and the people of the world;
and finally, in harnessing the power of big data and predictive
analytics to make us more efficient and capable of serving our
fellow Americans.
With a department the size and scope of HHS, it can be
difficult to prioritize. Nonetheless, should I be confirmed, I
do envision focusing my personal efforts in four critical
areas.
First, drug prices are too high. The President has made
this clear. So have I. Through my experience helping to
implement Part D and with my extensive knowledge of how
insurance, manufacturers, pharmacy, and government programs
work together, I believe I bring skills and experiences to the
table that can help us tackle these issues while still
encouraging discovery, so Americans have access to high-quality
care.
Second, we must make health care more affordable, more
available, and more tailored to what individuals want and need
in their care. We all share a common concern for our fellow
Americans who are struggling to achieve access to quality
health care, even if we do not necessarily agree on how best to
go about addressing that challenge.
Under the status quo, premiums have been skyrocketing year
after year, and choices have been dwindling. We have to address
these challenges for those who have insurance coverage as well
as for those who have been pushed out or left out of the
insurance market by the Affordable Care Act.
Third, we must harness the power of Medicare to shift the
focus in our health-care system from paying for procedures and
sickness to paying for health and outcomes. We can better
channel the power of health information technology and leverage
what is best in our programs and in the private, competitive
marketplace to ensure that the individual patient is at the
center of decision-making and his or her needs are being met
with greater transparency and accountability.
Finally, we must heed President Trump's call to action and
tackle the scourge of the opioid epidemic that is destroying so
many families, individuals, and communities. We need aggressive
prevention, education, regulatory, and enforcement efforts to
stop over-prescribing and overuse of these legal and illegal
drugs. And we need compassionate treatment for those suffering
from dependence and addiction.
These are serious challenges that require a serious-minded
sense of purpose, and if confirmed, I will work with the superb
team at HHS to deliver serious results.
I thank President Trump for this important opportunity to
serve the American people, and I thank this committee for your
consideration of my nomination, Mr. Chairman.
The Chairman. Well, thank you very much.
[The prepared statement of Mr. Azar appears in the
appendix.]
The Chairman. You are really qualified for this position;
in fact, one of the most qualified I have seen in my whole term
in the United States Senate. So I am really pleased you are
willing to sacrifice to come here and help turn this mess
around and get it working better.
Let me just ask this question. Mr. Azar, as you know, I
have fought hard to extend the CHIP program for a full 5 years
to support the 9 million families that rely on it. And I think
we will get this done as soon as possible. And when that
happens, HHS will have the 5 years of runway to work with.
What should HHS be doing to bolster CHIP and ensure its
continued success?
Mr. Azar. Well, Mr. Chairman, the Children's Health
Insurance Program is such an important part of your personal
legacy, and I really do look forward to the very swift
reauthorization so we can secure that program for this year and
for the years to come for our people. It really serves as a
very important bridge and stable force for the children of our
country.
I would just continue to look forward to working with you
and other members of the committee on any ideas that you have,
following reauthorization, in terms of implementation, ways
that we can make that program more responsive, more effective
for any of the beneficiaries in that program, ways that we can
make our programs more efficient so that we can spread the
dollars that you give us to reach as many children as humanly
possible, but very much just open-minded approaches from your
learnings, your extensive learnings with the Children's Health
Insurance Program.
The Chairman. Well, thank you.
Senator Cardin, we will turn to you.
Senator Cardin. Thank you, Mr. Chairman.
First, let me welcome Mr. Azar here. I particularly want to
welcome your dad, Dr. Azar, who is with us.
Mr. Chairman, Mr. Azar grew up in Salisbury, MD. His father
is a distinguished physician and was involved in the policy
development in our State of Maryland on health-care policy. And
I had a chance to work with him when I was in the State
legislature. So it is good to see the family that is here, and
we thank Mr. Azar for his willingness to serve in this very
important position.
So the first question I am going to ask you is going to be
a parochial one with Maryland--if necessary, I will get your
father involved here--and that is protecting some of the
initiatives that we have had in Maryland. We have, as you know,
an all-payer rate system for our hospital care that requires
the attention of HHS to make sure that we can continue to
provide this uniform-type service in our State.
Many States have come up with innovative ways to try to
help in our health-care system, and we had a chance to talk
about it, but I just urge you to pay attention to these types
of initiatives and be understanding that we may need some
special attention in order to be able to preserve this type of
access to care.
Mr. Azar. Senator, thank you, and thank you for the
wonderful meeting that we had where we got to discuss this
particular issue. If confirmed, I would love to come back home
to Maryland and spend time with you really learning more about
the Maryland approach. It is very innovative. It is cutting-
edge, and you have my commitment that, if I am confirmed as
Secretary, I will want to work with you and be a good partner
in that.
I think that all kinds of innovation and different
approaches at the State level, as you said, are what we need to
be trying. No one entity, no one person, has the right answers.
So I want to be supportive of you and the State of Maryland in
what they are trying to do here.
Senator Cardin. I appreciate that.
One of the major accomplishments under the Affordable Care
Act was to elevate the Office of Minority Health and Health
Disparities as a full institute at the National Institutes of
Health, but also to establish minority health offices in all
the agencies of HHS.
It is important that the Secretary get directly involved in
these issues. The historic discriminations in our country are
well understood.
Do we have your commitment that you will pay particular
attention to this particular priority to make sure that we do
right for minority health in America?
Mr. Azar. You do.
And thank you for your long-standing commitment in that
area. If confirmed, I would also just love to be getting your
ideas of ways we can--things that we can do to be better in
that space. The color of one's skin, one's sex, whatever, where
one lives--we ought to be doing everything we can at HHS to
ensure that people have the highest quality access to the value
care in the United States.
Senator Cardin. I want to talk about one area where the
Trump administration has deviated from previous Republican
administrations in re-imposing the so-called gag order which
deals with services on contraceptives and other areas, the
Mexico City policies. I disagree with this policy. I think it
compromises women's health in America. It compromises our
ability to work internationally with different organizations to
protect health generally, but the manner in which this was
implemented under the Trump administration is compromising our
ability to work with international health organizations in
dealing with issues from AIDs to malaria to so many of the
other issues in addition to women's health issues.
Are you willing to take a look at this to see whether we
can get a more rational way? Again, I disagree with the policy
to start off with, but the way it is being implemented now is
counterproductive to global health priorities, and it does
really require some attention of the Secretary and input into
the way that these policies are implemented.
Mr. Azar. So, Senator, I am not deeply familiar with the
ways in which any implementation of the Mexico City policy
changed at the beginning of this administration compared to the
past one. My sense is, there were some differences, as you
mentioned.
I want to learn more about that and would be happy to
discuss that with you. I clearly share the overarching view
that the United States needs to be deeply engaged in global
public health. The rest of the world's health impacts us.
As the Deputy Secretary's General Counsel, I was engaged in
those issues, with the leadership of Secretary Thompson and
Secretary Leavitt, so I am happy to look at that issue and
learn more about any changes that were made and hear from you
on that.
Senator Cardin. Thank you.
And lastly, you spoke in your opening statement about drug
prices being too high in this country. We all know that. We pay
about twice the average of Canada, on average, of the cost of
prescriptions. Globally, it is even more out of step.
Tell me how you intend to address this issue of bringing
down the cost of prescription drugs to consumers in this
country, particularly in light of your previous experience at
Lilly.
Mr. Azar. So, Senator, thank you.
I actually hope that from having worked these last several
years in that space, it brings a knowledge anyone else coming
in as Secretary--this is such a complex area. The learning
curve for any other individual would be so high. To just know
how that system works and what the incentives are, I think,
brings a great advantage to being able to hit the ground
running.
We need to deal with issues of competition. We have to
ensure we have robust generic competition, branded competition.
I want to ensure we create a very viable and robust biosimilar
market also, to compete against branded companies in that high-
cost biologic space. So that is critical.
I also want to make sure that we go after any types of
gaming or exploitation of exclusivities or patents by branded
drug companies. I fought against this when I was General
Counsel, actually led development of a rule that changed--for
the first time ever--regulations that saved $34 billion for
patients over 10 years as a result of our efforts.
There is no silver bullet here, though. I want to be very
clear. There is not one action that all of a sudden fixes this.
I want to hear ideas from others.
The most important thing we have to figure out is, can we
reverse the incentive on list prices? There is a lot that we
all know we can do on the discounted prices. But I want to work
with this committee and anyone who is smart and thoughtful
about creating incentives that actually pull down those list
prices so that, when the patient walks in needing to pay out of
pocket at the pharmacy, they are not hit with that kind of
cost.
That is one of the harder issues to solve, but I am deeply
committed to working with you on that.
Senator Cardin. I am sure my colleagues will have other
questions on this issue. Thanks.
Mr. Azar. Thank you.
The Chairman. Well, thank you, Senator.
I have some obligatory questions that I ask all nominees
before this committee that I have not asked yet. So I am going
to take the time to do that.
First, Mr. Azar, is there anything that you are aware of in
your background that might represent a conflict of interest
with the duties of the office to which you have been nominated?
Mr. Azar. No, Mr. Chairman. Although, I will follow the
advice of the career designated agency ethics officials to
ensure that I manage any potential conflicts that come about
through the ethics approvals as part of the confirmation
process also.
The Chairman. Well, thank you.
Second, do you know of any reason, personal or otherwise,
that would in any way prevent you from fully and honorably
discharging the responsibilities of the office to which you
have been nominated?
Mr. Azar. No, Mr. Chairman.
The Chairman. Third, do you agree without reservation to
respond to any reasonable summons to appear and testify before
any duly constituted committee of Congress, if confirmed?
Mr. Azar. Yes, Mr. Chairman.
The Chairman. Finally, do you commit to provide a prompt
response in writing to any questions addressed to you by any
Senator of this committee?
Mr. Azar. Yes, Mr. Chairman.
The Chairman. Well, thank you very much.
We will turn to Senator Grassley now.
Senator Grassley. As I promised you in my office, you would
know about the questions I am going ask. I only have two
questions.
The first one involves the Physician Payment Sunshine Act
that I worked hard to get passed and is part of Obamacare.
Background to my question: in March of 2017, the University of
Iowa reported a growing crisis of prescription opioid use and
overdoses in Iowa. While lower than some States, Iowa has seen
rates of prescription drug deaths quadruple since 1999.
In addition to concern about misuse of these drugs, I also
think it is important to protect patient access to needed
medications. One strategy to achieve that balance is to ensure
that prescribing decisions are made in the best interest of the
patient and not as a result of inducement to health-care
providers by drug companies.
Recent reports have raised concern about payments from
pharmaceutical companies to health professionals and the effect
on opioid prescribing practices. The bipartisan Physician
Payment Sunshine Act was designed to provide transparency
regarding payments to physicians from drug companies. This law
created the open payment database at CMS.
In November, Senator Blumenthal and I wrote a letter to
your department thanking them for the support that CMS's Center
for Program Integrity has given. In that letter, we further
encourage the prioritization of funding and administration of
the open payments database.
Now, you may wonder why I am asking this question. Before I
ask it, Mr. Chairman, I would like to have the Blumenthal-
Grassley letter and the University of Iowa report put in the
record.
The Chairman. Without objection.
[The documents appear in the appendix beginning on p. 162.]
Senator Grassley. A year ago--I think it was in the omnibus
appropriation's bill--a group of doctors and the House of
Representatives tried to gut this legislation. We prevented
that.
So a very simple question to you: will you commit to
continuing to collect and post all the data currently available
on the open payments website?
Mr. Azar. Yes, Senator Grassley.
As you know, I am a big supporter of the Sunshine Act and
your work there, and I supported it at the time that you had
first proposed it. I think that transparency is extremely
helpful.
Senator Grassley. Yes.
My second and last question: since the EpiPen
misclassification fiasco, I focused a lot of my oversight on
the Medicaid drug rebate program. In the course of my
oversight, I found that during the Obama administration, CMS
did not properly oversee the program, causing billions in
taxpayer dollar losses.
For just the EpiPen, the taxpayers may have lost out on
more than a billion dollars. It is kind of this way: $1.7
billion lost, but DOJ recovered $475 million, so a $1.3-billion
loss. Now why they did not go after the other $1.3 billion, I
never got an answer from DOJ.
In December 2017, the HHS Inspector General released a
report on the rebate program and found that hundreds of drugs
were potentially misclassified. For instance, out of a sampling
of just 10 drugs from 2012 to 2016, Medicaid may have lost $1.3
billion in rebates. Now that is just from a sampling. So we do
not know how many billions of other dollars may have been lost.
So my question to you--by the way, I would like to also
have submitted for the record a letter that I have to former
CMS Administrator Slavitt.
The Chairman. Without objection.
[The letter appears in the appendix on p. 166.]
Senator Grassley. Yes. Okay, thank you.
So this question--there is a lot of taxpayer money at stake
here. How will you approach fixing the Medicaid Drug Rebate
Program so that it is properly overseen and taxpayers' losses
are kept to a minimum?
Mr. Azar. Thank you.
Senator, I was very concerned to see the media reports and
to read that report from the Inspector General on the rebate
program. I certainly will work with Administrator Verma as well
as with CMS to ensure that the program is improved to get at
that.
One of the key issues, I think, is to ensure that the
regulations and guidance there are clear so that those
companies know what their obligation is, and if necessary,
moving to enforcement to ensure that they understand that these
are obligations that need to be held up.
Senator Grassley. Thank you, because doing that, you can
save a lot of taxpayers' money.
The Chairman. All right.
Senator Wyden?
Senator Wyden. Thank you, Mr. Chairman.
Mr. Azar, I am going to ask some questions about these
price issues, and we are going to hold up some charts.
Certainly, if you have any questions about the charts that are
being used, we welcome your comments.
During the 5 years that you were president of Lilly USA,
you had direct responsibility for pricing strategies of the
biomedicines unit, including the osteoporosis drug Forteo. You
also chaired the company's U.S. pricing committee.
I am going to quote how you described your role as it
related to Forteo in a written statement to the committee. You
said to the committee, ``As chairman of the Pricing,
Reimbursement, and Access Steering Committee for Lilly USA and
as the relevant profit and loss business unit leader for the
biomedicines business unit for the United States, I approved
pricing recommendations for this medicine.'' That is your
quote.
During your time in these positions, based on work by the
Finance Committee's Democratic investigative team, the
company's annual financial reports showed that Forteo's U.S.
revenue increased 58 percent, reaching $770 million in 2016.
Each year the company told shareholders that revenue increased
because Forteo's price went up.
You have told the Finance Committee that you were
responsible for approving the price of Forteo. So let us look
at the prices.
This chart that we are holding up shows the wholesale
package price of Forteo. And your watch is the red line, where
the price is just going up and up and up. The blue line, as I
indicated, is the price before you became president. The red
line is the price while you were president.
The price more than doubled on your watch from a little
more than $1,000 to more than $2,700. That is a 164-percent
increase in 5 years. The Wall Street Journal recently showed
how these price increases affected consumers when the paper did
a profile of one older person who was on Medicare who paid
$5,600 of her own money to buy Forteo after she broke her back.
Now, Mr. Azar, this certainly indicates the wholesale price
for Forteo in the United States, in fact, more than doubled on
your watch. Yes or no?
Mr. Azar. I believe that data is directionally correct. I
do not have the actual pricing information, but I believe that
is correct.
Senator Wyden. Okay. Let me take a look now at Strattera.
This is another drug under your purview which is used to treat
Attention Deficit Hyperactivity Disorder.
This chart shows how the price of the drug changed over the
years. Again, the price before you became president is blue.
The price while you were president is red. This is another big
jump in pricing that began shortly--based on our
investigations--after you became president.
If these were isolated incidents, it could be written off,
in my view, as an anomaly. It seems like people have gotten
hurt, but it would be an anomaly. But the company's annual
financial report showed that during your time at Lilly's U.S.
pricing committee--when you ran that--higher prices drove U.S.
revenue for drug after drug after drug, even when demand for
the products fell.
So one more question in this line of questioning: as
chairman of the U.S. pricing committee for this company, did
you ever lower the price--ever--of a Lilly drug sold in the
United States?
Mr. Azar. Drug prices are too high, Senator Wyden. I have
said that. I said that when I was at Lilly.
And every----
Senator Wyden. That is not the question.
Did you ever lower the price? That is the question I----
Mr. Azar. I do not know that there is any drug price of a
branded product that has ever gone down from any company on any
drug in the United States, because every incentive in the
system is towards higher prices.
And that is where we can do things together, working as the
government to get at this. No one company is going to fix that
system. That is why I want to be here working with you.
Senator Wyden. Let the record show that when that specific
question for Mr. Azar was asked--when the bipartisan Senate
Finance Committee was present--did he ever lower the price of a
Lilly drug sold in the United States, Mr. Azar said ``no.'' Let
the record show that that is what we were told.
And now we are going to have to make some judgments about
how you are going to approach the issues of helping to shrink
pharmacy receipts. You and I talked about legislation that I
have introduced that would ensure that the consumer got the
price reduction at the window. I introduced that legislation.
So we are probably going to ask whether you are going to urge
the President to support it.
The Chairman. Your time is up, Senator.
Senator Wyden. Okay.
Thank you, Mr. Chairman. I will have questions on the
second round. Thank you.
The Chairman. Okay.
Senator Enzi?
Senator Enzi. Thank you, Mr. Chairman and Ranking Member
Wyden, for your quick work in holding this hearing so that we
can move the nomination of Mr. Azar to the full Senate for
consideration.
The Secretary of Health and Human Services is a role that
should not sit vacant. There are too many vital priorities in
health care that need immediate attention, and I appreciate you
moving forward. I also appreciate Mr. Azar's willingness to
serve.
Mr. Azar, in my meeting with you after your nomination, I
was pleased to get your top priorities for your time as
Secretary, if confirmed.
Appropriately, he will be focusing on the affordability of
prescription drugs. This is something that everyone around this
dais knows about and hears from constituents about.
The problem is complex and does not have a simple solution,
but I am very encouraged to hear his commitment to taking this
on and know that he has real expertise and understanding of the
manufacturer side of the equation. I think that is something
that we really need. This is something that I believe can and
should have a bipartisan approach, and I hope to hear that kind
of commitment from my colleagues here as well.
Mr. Azar, you have listed and now restated your priorities
of drug prices, insurance market affordability and choice,
working toward a value-based system in health care, and the
opioid crisis. I completely agree. These are where the
Secretary's focus must be, and I look forward to working with
you to get that job done.
Mr. Azar has been before the Senate before, but I think
this environment this time around is obviously very different.
I am impressed by his willingness to go through this very
difficult process and appreciate his willingness to serve.
Now, to get to a question, Wyoming's Department of Health
has had a Medicaid 1115 waiver application sitting at the
Centers for Medicare and Medicaid Services for over 2 years. It
is a tribal uncompensated care waiver.
I understand that the waiver is under consideration, but I
would encourage you, if confirmed, to take expeditious action
in making a determination on this long-awaited application.
This is something that we have discussed before, which I know
that you, not currently being in the position, are not able to
comment upon. However, I would appreciate your commitment to
examining this application as quickly as possible.
Mr. Azar. Senator, thank you for raising that, and again,
thank you for taking the time to meet with me.
I obviously do not know the parameters on the Wyoming
waiver, but I will tell you that I am very concerned about the
amount of time that you have mentioned that it has been
pending. I do want to ensure that if I am confirmed as
Secretary that CMS works with the States on any of these
demonstration projects or waivers as a very good partner and is
responsive and timely.
So I will, if confirmed, get on that right away, looking at
that for you with Wyoming.
Senator Enzi. Thank you very much.
Now you have also talked about your priorities on drug
pricing, and that seems to be the topic here. I appreciate your
willingness to take on that very serious and complicated issue.
I appreciate the background that you bring to that issue.
I am sure you are familiar with the announcement by
Novartis about their discussions with CMS to think differently
about how they price the new leukemia drug Kymriah. I know that
is not a finalized agreement. I know there is not long-term
data showing how these kinds of arrangements work.
But it seems like an interesting approach and one that is
worth exploring further. What is your view of value- or
outcomes-based contracting in the private sector and the
possible applicability to public payers like Medicare?
Mr. Azar. Senator, I think value-based or outcome-based
contracting around--first, generally within the health-care
system, but especially with medicines, can be vitally
important. And I also think that there are some of the
regulations and approaches that we have within Medicare that
actually get in the way of that.
I know that when I was doing this in the private sector, I
wanted to be able to put our money where our mouth was, to say,
if it works, pay us. If it does not work, take a greater
discount. But some of the rules around government price
reporting--and other rules--can actually be a barrier to that.
I think there is actually fairly broad bipartisan support
to try to address those to open the door to that so we could
get real value-based contracting, paying for value and paying
for outcomes on these medicines. So I am quite excited and
think that can be an important part of how we think about drug
pricing and value for taxpayers and for customers.
Senator Enzi. Thank you.
I appreciate the expertise you bring, but also the record
that you have of working in the government in the past. So
thank you for being willing to serve.
I yield the balance of my time.
The Chairman. Thank you, Senator.
Senator Stabenow?
Senator Stabenow. Thank you, Mr. Chairman.
I first want to personally thank you for your commitment on
the Children's Health Insurance Program. I have a real sense of
urgency about this as you do, and I want to thank you as well
for your leadership over the years.
The Chairman. Thank you.
Senator Stabenow. Mr. Azar, welcome. Welcome to your
family.
You have indicated that you will hit the ground running,
and my question is, in what direction will you be running? And
I think that is the real question.
I share the concerns of Senator Wyden in terms of what
happened when you were at Eli Lilly. The fact is--and I will
talk about just another drug, and that is Humalog, insulin, and
the fact that that particular product is so critical for
people, obviously with diabetes.
From 1996 to 2017, it went up 700 percent. During the time
that you were at Eli Lilly, it also doubled. It doubled in
price. So I am wondering, when you say that drug prices are too
high, do you agree that $255 for Humalog, for one vial--and
multiple vials are needed--do you believe that $255 for one
vial is too high?
Mr. Azar. So across the board, drug prices are too high,
including for any product like that. And insulin's prices are
too high. All drug prices are too high in this country.
And the increases, you know, this is what is so bizarre
about the way the system is organized, that those price
increases happen--and my former employer has said this
publicly--yet during that same period, the net realized price
by the company stayed flat. And yet the patient who is walking
into the pharmacy--so just to cover for increased rebates, the
patient walks into the pharmacy whose insurance may not be
paying for that, and is absorbing that cost.
That is what I want to work with you to try to solve.
Senator Stabenow. Well, Mr. Azar, first of all, insulin was
basically first approved 100 years ago. So any cost to the
company to recoup for any R&D in addition to what taxpayers pay
for would already have been done.
I appreciate that you say that it is too high. Yet in that
position, with this system, you doubled the price.
So you were taking advantage, certainly, of that system.
That was a choice that you had as president, which is of
concern to me, because I am assuming the price of manufacturing
the insulin did not double. Is that correct?
Mr. Azar. So you know this--I do not have the data. I did
not run the diabetes business unit at Lilly, so I do not have
the data on the price of manufacturing.
The system, it works for those players in the system, but
it does not work for the patient walking into the pharmacy.
Senator Stabenow. Okay.
Let us talk about how to make it work.
Mr. Azar. I would love to.
Senator Stabenow. President Trump has been back and forth
on this, but he has said in the past that he supports
negotiating prescription drug prices. Do you believe the
government should negotiate prescription drug prices?
Mr. Azar. I think where the government does not have
negotiation, it is worth looking at. So for instance, one of
the things I have talked about is in Part D, we do significant
negotiation through pharmacy benefit managers that get the best
rates of any commercial payers. We do not do that in Part B,
which is where we have physician-administered drugs. We
basically pay sales price plus 6 percent or some other number.
I would love to take those----
Senator Stabenow. So just in the interest of time, I am
really--I do not mean to be rude, but in the interest of time--
so you are saying, yes to negotiation of prescription drugs,
because----
Mr. Azar. Where we can do so, that preserves innovation and
preserves access for patients. I want to look at anything that
is going to help us with drug pricing.
Senator Stabenow. Okay.
Mr. Azar. So in Part B, I think we should be looking at
those approaches.
Senator Stabenow. Okay.
So the National Academies of Sciences, Engineering, and
Medicine have indicated that buyers in the biopharmaceutical
sector, buyers often appear to be in a weak position with
little alternative but to purchase the drug at whatever the
price. They say the effect of not allowing HHS to negotiate
prices is to tilt the bargaining power further in favor of drug
manufacturers.
Now Part D, as it was originally passed, basically
prohibited--it was on the side of the drug company saying, you
cannot negotiate.
So do you support changing the law so that under Medicare
Part D you can negotiate on behalf of seniors and the American
people to bring prices down?
Mr. Azar. So right now, negotiation is happening in Part D.
It gets the best rates there are out there.
The National Academies--they are just wrong on that. These
are incredibly powerful negotiators who get the best rates
available.
Senator Stabenow. So when they say it is in favor of the
drug companies, you disagree with that?
Mr. Azar. They are incorrect.
Senator Stabenow. You disagree with that. All right.
Mr. Azar. For the government to negotiate there, we would
have to have a single national formulary that restricted access
to all seniors for medicines. Even CBO, Peter Orszag, has said
this. That would be the only thing that could change. I do not
believe we want to go there in restricting patient access.
Senator Stabenow. Well, the President's Commission on
Combating Drug Addiction and the Opioid Crisis also recommended
using emergency powers for naloxone, a lifesaving drug related
to the opioid addiction problem. They just recommended that
negotiation be used for that lifesaving drug against opioid
addiction.
Would you support negotiation for that drug?
Mr. Azar. So Senator, I want to look at that and learn more
about that situation. But if the government is the purchaser--
so let us say, for instance, if we are going to be buying that
as part of the opioid crisis program, and we are directly
buying that and supplying it out to States and first
responders, there is absolutely nothing wrong with the
government negotiating that.
I did that with ciprofloxacin, under Secretary Thompson,
during the anthrax attacks. There is nothing at all wrong with
the government directly negotiating for value when we are the
purchaser, and then if we are supplying that out.
I need to learn more about that issue from within the
government.
Senator Stabenow. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator.
Senator Thune?
Senator Thune. Thank you, Mr. Chairman.
Thank you, Mr. Azar, for being here today. Congratulations
on your nomination, and thanks for your willingness to serve,
and to your family for being willing to put up with the demands
that come with being involved in public life.
I think we all share your priorities of lowering the cost
of health care and prescription drugs. I hope that based upon
your past experience--it is an industry, obviously, that you
understand, that you can help us with with suggestions about
how to get those drug prices down, because that is an
incredibly important part of health care today, and an
incredibly costly part, unfortunately.
So I look forward to working with you on these issues. We
have discussed this previously, but we have providers in South
Dakota that are working to innovate and ensure access to care
for folks in rural areas and in Indian country, yet we have a
lot of challenges that exist.
For years the Indian Health Service facilities in South
Dakota have been found to have serious deficiencies and poor
quality of care. For instance, Pine Ridge recently lost its
ability to bill Medicare and Medicaid for failing to meet CMS
standards. This has to change.
I have been working with Senators Barrasso and Hoeven on
the Restoring Accountability in the IHS Act to give HHS greater
authority to get IHS back on track. And specifically, the bill
would give HHS the authority to terminate poorly performing
employees, streamline the hiring process, and create incentives
for quality providers to remain on the job.
Is this something that you agree you could work with
Congress to achieve?
Mr. Azar. Absolutely, Senator. I look forward to getting
those additional authorities, and I also look forward to any
ideas you have. It is unacceptable for us to not be providing
high-quality service there.
Senator Thune. Okay. I appreciate that and look forward to
working with you and your team.
As you know, I have been supportive. I share this, I think,
as well with you: the desire to find solutions to address the
application of Medicare competitive bidding rates in
noncompetitively bid areas, an issue that South Dakota medical
equipment providers report has caused supplier closures and
gaps in Medicare beneficiary access.
HHS was supposed to have issued a report to Congress--this
came per the 21st Century Cures Act--on beneficiary access by
January 12th of 2017. I am not aware the report has been
completed. So I would request that, once confirmed, you would
work to have that report completed quickly.
Additionally, if confirmed, I would ask that you commit--
will you commit to working with the Office of Management and
Budget to quickly approve the interim final rule to provide
relief for rural providers that has been pending since October
of 2017?
Mr. Azar. Yes, Senator. I would be happy to work on those
issues. Thank you.
Senator Thune. Thank you.
In the face of provider shortages, South Dakota's health
systems have increased access to care in rural areas through
telehealth. As you may be aware, several Senators have been
working on the Connect for Health Act, which would further
expand the use of telehealth and remote patient monitoring in
Medicare.
Importantly, one provision of that legislation would
provide the Secretary of HHS the authority to waive certain
restrictions in current law where telehealth would reduce
spending or improve quality of care. If confirmed, would you
support Congress enacting that provision to provide you the
discretion to expand access to telehealth services?
Mr. Azar. Senator, as we had the opportunity to discuss
together in our meeting, I am a big supporter of telehealth and
alternative means of providing care, especially in rural
communities. I think sometimes we can be penny-wise and pound-
foolish in these areas.
Senator Thune. Thank you.
Mr. Azar. I would love to work with you on that.
Senator Thune. I look forward to working with you and your
team on that as well. It is something that has tremendous
potential to deliver benefits to areas of the country for
which, in many cases, it is difficult to get delivery of
health-care services in a timely and a cost-effective way.
So thank you for your answers to those questions. We will
hold you to them and follow through with you and look forward
to working with you once you are officially installed there. It
is a big job, as you know, with lots of moving parts, lots of
challenge, but also lots of opportunity to really make a
difference in the lives of people in this country who need
access to more affordable health-care services.
Mr. Chairman, with that, I yield the balance of my time.
The Chairman. Thank you, Senator.
Senator Casey?
Senator Casey. Mr. Chairman, thank you very much.
I want to reiterate what Senator Stabenow said earlier
about your service. We commend you for your service and the
work you have done over many years in the Children's Health
Insurance Program. I hope we can get that done in the next
couple of days, I hope by the 19th. We are grateful for that.
Mr. Azar, thank you for putting yourself forward for
service, again, in the Federal Government. It is good to see
your family.
You and I have common State roots: Scranton and Johnstown.
But despite those commonalities, we have a lot of disagreements
on health-care policy. I wanted to explore that.
First and foremost, I appreciate the time you spent in our
office going back a couple of weeks ago when you were coming
before the Health, Education, Labor, and Pensions Committee, a
committee of which I am a member. And at that time, we talked a
good bit about health-care policy, in particular Medicaid,
which is a program that I think many Americans appreciated over
many years, but probably never more so or never with greater
urgency than this year, when there were proposals which in my
judgment--and I think in the judgment of a lot of folks who
have followed health-care policy for their whole lives--would
have decimated it, some of the proposals this year that were
put forth.
I tend to focus on it not only in a programmatic sense, but
in a people sense when we get letters from families that are
very concerned about Medicaid. I got a letter last year from
Pam Simpson. She is from southeastern Pennsylvania.
She was talking about her son Rowen. This is the letter she
sent me, back and front. Pictures--you cannot see from where
you are, but she concluded the letter by making a plea to me to
protect Medicaid because her son Rowen--she described in a
letter what his life was like without Medicaid, which we call
Medical Assistance in Pennsylvania, and how much better it was,
all of the treatment and therapies and benefits that Rowen
received.
She ended the letter talking about--or as I said, pleading
with me to make sure we take steps to protect it, saying that
we should think of her and her husband and their inability to
make ends meet without Medicaid--obviously to focus on Rowen's
life with it. Then she also said, ``Please think of my
daughter, Luna, a little girl who is actually younger than
Rowen''--he was only, at the time, about 5 years old--saying
that she will have to care for him when they are gone because
of his own circumstances.
In the last line of the letter she said, ``We are
desperately in need of Rowen's medical assistance and would be
devastated if we lost these benefits.'' That is what one mom
said about her family and her own circumstances.
I guess I would ask you a broad question. If the proposals
put forth in all of the Republican health-care bills this year
were enacted into law or--I should say and/or if the
administration's proposals on Medicaid, and proposals I think
you support, would become law, would Rowen Simpson lose his
Medical Assistance?
Mr. Azar. So first, as you mentioned, we are from the same
State. I think we actually share a lot of the same goals for
our people for access to care, for access to insurance, for
access to quality. Sometimes we may differ about the role of
government, the size of programs, techniques, whatever, but we
share that commitment. And I share the commitment to the
Medicaid program. It is a vital safety net program for our
folks.
I do not know that individual's particular circumstances
and how they qualify for Medicaid. But obviously, for so many
families, Medicaid is a vital link or a bridge to independence
eventually or long-term need for them.
If confirmed, my job will be to make that program as
efficient, as effective, as responsive, and as available to
everybody as possible.
Senator Casey. But as you know, under current law, there is
a guarantee. As long as you are eligible, or I should say some
are eligible, some have a guarantee by way of their disability.
So, even people of significant means, with jobs and health-care
coverage, can avail themselves of Medicaid because of a
disability.
My question is, will that guarantee remain in place not
only for children with disabilities but for adults as well?
Mr. Azar. I think, in whatever we do in Medicaid, we have
to make sure it is doing its job. And for an individual like
that with disabilities who needs to be categorically in, we
have to make sure it is funded and supported to do its job for
them.
Senator Casey. I would also ask just in the context of
adults, and I know we are running low on time, if you have an
individual who relies upon a disability service provider,
someone who needs a wheelchair, durable medical equipment, will
those individuals continue to get those services?
Mr. Azar. Again, on any type of reform, those are the kinds
of situations we have to look at to make sure that we are still
able to deliver for those individuals.
Senator Casey. Mr. Chairman, I know we are running low on
time, but I will try to come back in a second round.
Thank you.
The Chairman. Thank you, Senator.
Senator Portman?
Senator Portman. Thank you, Mr. Chairman.
I have had the pleasure of getting to know Alex Azar in his
previous roles in government. In fact, when he worked in the
Bush administration at HHS, I got to see him in action.
And I can tell you from personal experience, he knows his
way around the Department. He has a lot of integrity, a lot of
friends and allies here on the hill from those days on the job.
In fact, you would not know it from some of the comments
made here today, but he has actually been confirmed twice by
the United States Senate as General Counsel and also as Deputy
Secretary. By the way, both times it was by unanimous consent.
So not a single member objected, and that is because he has
the experience. He has the background. And I am glad someone
with his experience is willing to step forward, because,
frankly, we have a lot of challenges, and it is a big,
complicated department.
In our conversations, we spoke a lot about the opioid
epidemic and what I believe can be done in addition to what is
already being done, and there has been progress made in the
last couple of years. But HHS plays a central role.
Right now you are helping us implement the Comprehensive
Addiction and Recovery Act through SAMHSA, through CDC,
through, obviously, Medicaid and Medicare--Medicaid in
particular. So this is all going to be part of your bailiwick
should you be confirmed.
There is an issue that I think has a very specific HHS
element I want to get your views on today--I am not sure we
talked about this specifically in our meeting--and that is
improving access to care.
This has been something that many of us have worked on over
the years. Senator Durbin and I have a bill called the Medicaid
Care Act, which would lift this Medicaid Institutions for
Mental Disease exclusion, otherwise known as the IMD cap. This
is for residential treatment programs as you know.
It is crazy to me that there is a cap of 16 beds on some of
the really good, successful residential treatment programs in
Ohio that I visited. They literally turn people away because
they do not have the ability, based on their taking Medicaid
and being involved in the IMD program, to be able to have
access. It makes no sense.
I understand why it was put in place in the first place.
More on the mental health side--trying to fight back against
institutionalization, but I think it needs to change.
So my question to you would be, knowing that CMS has tried
to be supportive--the 1115 waivers have been accepted in some
cases. But there are still a lot of restrictions on those.
Would you support legislation? Our legislation raises the
cap from 16 to 40 beds, for instance. And we have some pay-fors
that we are working on.
Would you be supportive of such legislative efforts?
Mr. Azar. Obviously, as a nominee, I cannot commit the
administration on legislation. I can tell you personally I do
not understand the existing restrictions, and especially in the
face of the opioid crisis and the pressing demand and need for
treatment for these individuals.
So I would love to work with you on that, if I am confirmed
as Secretary. I do not get it, and I would love to work with
you on it, if we could fix it.
Senator Portman. I appreciate that answer. And again, it is
not something I think you expected me to raise. I am not sure
we talked about it in our meeting as much as some of these
other issues that had to do with the prevention and treatment
side.
But thank you for that comment. That is another reason I
think you would be good in that job, because we need to get
that cap raised. And again, we have to pay for it. We
understand that. We have some thoughts about how to do that,
and I think it is absolutely crucial right now in my State and
so many other States that are getting hit so hard by this
opioid epidemic.
Another issue you and I talked about was wellness and
prevention. You touched on that a little bit today in your
comments to, kind of, rethink how we approach health care in
the country.
Paying for good health includes, in my view, providing
incentives for better wellness programs. Senator Wyden has been
a leader on this. We have introduced legislation in the past
called the Better Rewards Bill.
It basically says that for Medicare beneficiaries, they
would be given an incentive program to be able to help them
with, whether it is smoking cessation, or whether it is heart
disease, or whether it is diabetes prevention, things that over
time will save the government some money, obviously, but most
importantly to me, to make their lives more healthy so they can
live longer, healthier lives.
It has worked in the private sector. There is no question
about it. Cleveland Clinic in Ohio is probably the best case of
that, where they have put this in place for their own
employees, and they have seen enormous improvements in people's
health. By the way, it is a modest incentive. I know it works,
because it works in the private sector, and I believe among
seniors it will work even better.
So my question for you is that Senator Wyden and I are
looking at maybe trying to make some changes to reintroduce the
legislation because, frankly, the Congressional Budget Office
does not give us the score they should in my view. But what is
your view of this kind of legislation? Would you support it?
And I do not think it should be limited to Medicare. I think
Medicaid also has an application for this kind of prevention/
wellness program.
Mr. Azar. So, Senator, I have long been supportive of these
types of wellness and prevention programs, even when I was
General Counsel and Deputy Counsel at HHS as we looked at our
own regulations under HIPAA, to enable these types of programs
in the first instance, and I will be happy to work with you on
that.
I do think it comes up so often where Medicaid and Medicare
were designed in the 1960s with, sort of, silos. We will pay
for this; we will not pay for that. Now 50 years later, we can
be penny-wise, but pound-foolish, as I said before about saying
what we will not cover because it does not fit in a category,
even if it is going to produce better health for our people and
is going to save us money.
So I am very happy to work with you on that.
Senator Portman. Well, I appreciate that attitude.
I know my time is expired, and I look forward to your
confirmation.
Thank you, Mr. Chairman.
The Chairman. Thank you.
Senator Nelson?
Senator Nelson. Thank you, Mr. Chairman.
It is either ``congratulations'' to you, but it is also
``thank you'' for 4 decades of extraordinary service. And thank
you also for your personal friendship.
Mr. Azar, there is a lot of chatter up here about how now
we have a trillion-and-a-half-dollar hole, additional budget
deficit over the next 10 years. That is added to the national
debt. There is a lot of chatter among our Republican colleagues
that we need to make up for that.
So they are specifically looking at Social Security,
Medicaid, or Medicare under the guise of so-called ``welfare
reform.'' Tell me, do you think in welfare reform that it ought
to be Medicaid, Medicare, and Social Security that would be
cut?
Mr. Azar. So, Senator, I am not involved in discussions
right now. I am a private citizen. I am not involved in
discussions about what is even being contemplated. So I am not
aware of cuts in any way being supported by the administration
and the President.
Senator Nelson. I am asking you for your opinion. You do
not have to comment on what all the Republican Senators are
saying--your opinion. Would you consider an order to make up
all of this huge budget deficit hole by cutting Medicare,
Medicaid, and Social Security?
Mr. Azar. The President has stated his opposition to cuts
to Medicare, Medicaid, or Social Security. He said that in the
campaign, and I believe he has remained steadfast in his views
on that. My job as Secretary would be to enforce that.
Senator Nelson. So would you advise him to keep his word?
Mr. Azar. He has kept his word. I would stick with him on
keeping his word on that as long as--but I do not have the
broader context of any discussions going on. I am here on the
sidelines of this. He has made that commitment. I will live up
to that, if I am confirmed--to keep his commitments.
Senator Nelson. The last HHS Secretary made some
interesting statements about what he preferred. I am curious as
to what you prefer.
Do you support raising the Medicare eligibility age?
Mr. Azar. So I have not voiced support for that. That would
have to be considered in the context of everything else.
What we have to do, Senator, is make sure that Medicare is
going to be sustainable for our beneficiaries over the long
run. I know you agree with that. We need to come up with the
right approaches. I, frankly, would like us to run Medicare
more efficiently and effectively, as I have said, more driving
value and outcomes.
And I think we can stretch that program and make it more
sustainable over time just by how we operate it. We can also,
as a result of that, lead to great transformation in the
broader commercial health-care system if we do that.
That is where my energies are.
Senator Nelson. Well, let the record reflect that the
witness did not reject increasing the Medicare eligibility age.
I might say, if you get out among the people, you are going to
run into people who get into their 50s and 60s, and they are
just holding on for dear life because they do not have any
health insurance until they reach 65, because they know they
get Medicare. And they do not want it extended.
Do you support turning Medicare into a voucher program?
Mr. Azar. I am not aware of any proposals by the
administration to turn the program into a voucher program. What
I want to do, again, is really make sure that our Medicare
Advantage program--which two-thirds of new enrollees are
signing up for and which I played a role in helping to launch--
is an option for our seniors as they come into the program.
They like it, have high levels of satisfaction. So I really
want to make sure that we are doing everything we can to make
sure it is a strong, robust alternative for our seniors. Again,
that is where my energies are. My thoughts are there.
Senator Nelson. Do you support closing the doughnut hole in
the Medicare law?
Mr. Azar. So closing the doughnut hole--the Affordable Care
Act actually did have some funding that actually helped senior
citizens when they arrive at the pharmacy. I think it gives up
to 75 percent coverage in the doughnut hole----
Senator Nelson. Yes----
Mr. Azar [continuing]. Which I am very supportive of.
Senator Nelson. You are?
Mr. Azar. Yes.
Senator Nelson. Of keeping all of that?
Mr. Azar. Absolutely. Yes.
Senator Nelson. Tell me about Medicaid. What is your idea
about Medicaid?
Mr. Azar. Well, I want to make sure that we enable
flexibility for States to run those programs in ways that meet
the needs of their citizens. As I said with Senator Enzi
earlier, I want to make sure that in working with the States,
who have the on-the-ground responsibility, that we are being
responsible and responsive partner of theirs in looking at
flexibility, trying new things.
Senator Nelson. Excellent. Excellent.
Now, how about Puerto Rico?
The Chairman. Senator, your time is up.
Senator Nelson. Puerto Rico. Medicaid for Puerto Rico. It
is a block grant. It cuts off.
Mr. Azar. I think we all need to work together on that
Puerto Rico cliff issue. I agree with you: we need to work
together to find solutions there.
The Chairman. Okay.
Senator Scott?
Senator Scott. Thank you, Mr. Chairman.
Mr. Azar, good morning. Thank you for being here.
I know that drug pricing is very important. I think also,
beyond drug pricing, the issue of health insurance cost as well
is very important.
South Carolina, in 4 years, made 120-percent increases.
This last year was a 31-percent increase on the exchange. So
there is no doubt that we have to find a way to rein in the
prices that our consumers are being impacted by in the health
insurance arena.
One of the ways that we do that, I think, would be through
the section 1332 waivers, giving States more flexibility, at
the same time looking at ACA as the foundation, because we have
to. The catastrophic plans are limited to 30 years old and
below.
I have legislation co-sponsored by Senators Carper, Warner,
and Cassidy that would allow for the catastrophic plans to
cover anyone who needs the coverage or who wants the coverage.
One of the things I have often criticized within the ACA is
that the design plans are not suited for the actual individuals
who want to buy the plans.
So as our next Secretary, what would you do to expand
consumer choice and encourage Americans to make healthy,
proactive decisions?
Mr. Azar. So I think, in terms of the Affordable Care Act--
I am glad you raised the issue of increasing premiums and lack
of choice that you are experiencing in South Carolina. I
believe, if I am confirmed as Secretary, I have a very
important obligation to make whatever program that I am
entrusted with work as well as possible.
Senator Scott. Yes.
Mr. Azar. What we have now is not working for people. It is
not working for the 10 million who are in that individual
market right now, fully. So for many of those people, it can be
a false insurance card. It can be insurance, but a very high
deductible or not having access to providers. So it is
unaffordable use of care.
I want to solve the problem for them.
Senator Scott. Good.
Mr. Azar. I want to fix the program, as you just mentioned,
for the 28 million people who sit outside of that market still,
who do not have access in that individual market. And by not
being in that market, they are actually causing the premiums to
go up for the 10 million in it.
So can we make those offerings? Can we create more choice
and make those offerings more attractive to create a better
risk pool that is going to help also the taxpayer and people in
that market?
So I fully share that commitment. And I want to work with
States on these 1332 waivers and work with our authorities to
just try to make that health insurance more affordable, and
make it real insurance, and make it tailored to what they feel
they need.
Senator Scott. Thank you.
The next question for you is on the opioid crisis that we
are having throughout this country. In 2016 there were 64,000
deaths related to opioids. That is a crisis.
In South Carolina, 616 folks lost their lives, a 9-percent
increase. I would love to hear your commitment, not only to
address the issue from Washington, but to ask you to let us get
outside of Washington. Let us go to the rust belt. Let us go to
the places where people are suffering today because of opioids.
And let us create remedies that actually work, that are not
top-down simply, but truly bottom-up.
Evidence suggests that the best remedies so far have been
created through a collaborative effort starting at the local
level and moving its way up. I would love to hear you commit to
not only running the HHS, but going to places in West Virginia
where they have the highest per capita--I think it is 41 out of
100,000 deaths associated with opioids in places like Horry
County, Myrtle Beach, where we have the highest level in South
Carolina.
But if we are going to understand and appreciate this issue
in a very favorable way, we are going to have to do so by
putting a face on the issue, not in Washington, but somewhere
around the country. Are you committed to actually going to
those places with us?
Mr. Azar. Absolutely. Senator, you know I am a Hoosier, so
I am right in the epicenter of the crisis also in Indiana.
Senator Scott. Absolutely.
Mr. Azar. I do believe that there is not necessarily,
especially when it comes to prevention and treatment programs,
a one-size-fits-all approach. And we need to get out there and
see what is working, what are the different programs, not just
so that we can support them, but also so we can replicate them
and make them available elsewhere at these epicenters. That is,
of course, in addition to things we can do at the center with
regulatory authority, with education programs, et cetera, that
have to drive solutions on this crisis.
Senator Scott. I only have about 30 seconds left, so I will
not ask a question. I will just make a statement that
encompasses my last two points.
Number one, your expertise in the value-based arrangements
will be helpful. I think when you look at the opportunities of
the future, from BCI to CRISPR, there are a lot of innovative
opportunities coming that will improve the quality of life of
everyday Americans in ways that we could not even imagine 5
years, 10 years ago.
I would love for us to be able to find ways to make that
access to life-changing opportunities affordable.
Second, as we think through drug pricing, I also think that
we have to understand and appreciate the necessity of non-
addictive alternatives and the pipeline to get there. So I hope
that there is a plan in place that you are thinking through for
an expeditious approach to non-addictive remedies as well as
things that provide abuse deterrence.
Mr. Azar. That last point, that is a core area of NIH's
focus and their public-private partnership: to try to drive
non-addictive pain treatment therapies to replace the legal
opioids that are getting us into this mess.
Senator Scott. I would love to talk with you about that
later.
Thank you.
The Chairman. Senator Warner?
Senator Warner. Thank you, Mr. Chairman.
Let me join all of my colleagues, as well, in acknowledging
and recognizing your great service to this committee and to the
people of Utah and the Senate.
The Chairman. Well, thank you.
Senator Warner. We are going to miss you, and I very much
appreciate our opportunity to work together and the fact that
when you had a chance to bump me off this committee, you kept
me on this committee. So I am grateful for that.
Mr. Azar, it is great to see you again.
I know some of my colleagues have already been asking about
drug pricing. One of the areas I have felt strongly about for
some time is, while there are specific policies that we can
implement, I have been concerned that in many ways Americans
pay for the R&D, for drug pricing for the whole world. And part
of the way--we can make programmatic changes here, but some of
this also has to be dealt with in our trade policies.
I mean, amongst all the OECD nations, we pay the highest
percentage on drug prices. Recognizing that you bring more than
a little experience in this matter and in your role at Lilly
were involved in the whole pricing issue, what do you think
about how we bring down Americans' cost of drugs vis-a-vis all
the other industrial nations in the world?
Mr. Azar. Well, Senator, again, thank you for meeting with
me and for raising that important question. I have actually
talked about this as a critical issue for, I think, over 15
years when I was in government before, the fact that Europeans,
Canada, Japan are not paying their fair share.
They started, finally, investing more through the framework
basic program at the European Union and some of the NIH-like
basic primary research and funding there, but on the commercial
side, they are not paying more, and they are able to have
single-payer socialist systems with single formularies that,
basically, are take it or leave it pricing.
I do think we have to address that through trade agreements
as well as trade negotiations with these trading partners, the
fact they are not paying. But that, of course, does not solve
the pricing here. That helps with relieving some of the burden
of R&D abroad. We have to address that here with some of the
measures I have talked about or other measures. I would love to
hear any ideas you or others have, because we are going to
solve this issue at the list price level, and at the net price
systemic savings level.
Senator Warner. How much more transparency, though, should
we have after companies raise their prices? I mean, in terms of
the rationale behind--it seems like it is a mismatch and more
than a bit arbitrary at this point.
Mr. Azar. So I am generally in favor of more transparency
in the system. I think it is generally very helpful.
We always have to be careful with anything around pricing
to make sure we are not doing something that actually could be
anti-competitive or actually be counter-productive in what we
are trying to do. But if you have ideas there, I do think
transparency can be part of the solution as we bring
understanding. Where is the money flowing in the system? Who is
getting the benefit from it? And what is the benefit or harm to
the consumer?
Senator Warner. I just have to tell you, as someone who for
a long time did accept the premise that we need to do the R&D
here, that argument has run thin with me as we have seen
Americans disproportionately bear this burden. And I think we
are going to need some maybe more radical thinking than what we
have had in the past.
I want to touch on two other items. I know in your
statement you said, harness the power of Medicare to shift the
focus in our health-care system from paying for procedures and
sickness to paying for health and outcomes.
Obviously that is--everyone makes those comments. One of
the things that came out of the Affordable Care Act was CMMI,
and while it has not been as productive as I would have liked
to have seen at all times, I think it is still a tool that is
useful, and I would like your comments on how you would see the
role of CMMI going forward.
Mr. Azar. I completely agree with you and believe CMMI is
going to be one of the very important tools we have to drive
this type of transformation of our health-care system through
Medicare. We need to ideate, to pilot, to test, and then
generalize.
Senator Warner. And I would hope that we would realize that
some of those pilots may--and I know we might have a
disagreements on this one--include mandatory pilots, because
too often those who are on the voluntary system are the ones
who have already been able to bring about efficiency. So we
need to force more into the system.
Mr. Azar. Senator, we actually do not disagree there. I
believe that we need to be able to test hypotheses. And if we
have to test a hypothesis, I want to be a reliable partner. I
want to be collaborative in doing this. I want to be
transparent and follow appropriate procedures.
But if to test a hypothesis there around changing our
health-care system, if it needs to be mandatory as opposed to
voluntary to get adequate data, then so be it.
Senator Warner. Let me get in my last bit here in 15
seconds.
An issue that Senator Isakson and I have been working on
for a long time is advanced care planning and end-of-life
issues, and CMS, obviously, made a major step forward a few
years back where they went ahead and put a coding in for that
consult. I would just like to get you on the record in terms of
recognizing that we do not want to limit anyone's choices, but
we also want to honor and respect people's choice about care
planning or end-of-life issues.
Mr. Azar. I think it is a very important part of all of our
personal care management, as we think about our life and our
health care and our family members, that we engage in that kind
of thoughtful, directive planning of what do we desire. Again,
as you said, none of us--it is not about imposing anyone's
views on someone else. It is actually about ensuring systems to
respect that individual's choice.
Senator Warner. Right. Absolutely
Mr. Azar. So enabling that, I think, is very important for
us.
Senator Warner. Thank you, Mr. Chairman.
The Chairman. Thank you, sir.
Senator Heller?
Senator Heller. Mr. Azar, welcome and congratulations. I am
thrilled to have you in front of our committee. I welcome your
family also, who are being very patient through this hearing.
I may ask you some questions that maybe have already been
asked, because I have been down at the Banking Committee, going
back and forth a little bit here. So I apologize if anything I
do or say is duplicative.
I was proud, as you know, at the end of last year to work
with some of my colleagues here on this committee as we worked
through the historic tax reform bill. And as you are aware of,
portions of that eliminated the individual mandate tax penalty.
And I think that the Obamacare individual mandate was
probably the most unpopular element of that law. And its
penalty, in my opinion and others, disproportionately affected
hardworking Nevadans and Americans across the country who
really are struggling to get by.
So repealing that mandate, I believe, restores individuals'
abilities to make their own choices about their health
insurance and prevents the Federal Government from penalizing
these individuals who cannot afford this insurance.
So I guess my main question to you, as we have discussed
both in my office and will discuss here, is, under your
leadership, will HHS--what will you improve? What are you
looking for in quality of access, affordable care, some of
these issues, as we are trying to move forward? Because clearly
with you in this position--and I am pleased to see you here,
taking time to answer these questions--we really need to take a
look at affordability and access to health care for Nevadans
and clearly all Americans.
Mr. Azar. Absolutely, and as you mentioned, the way we are
doing it now is not working for everybody. That is going to
be--if I am confirmed, my job is to take whatever I've got, so
the Affordable Care Act is there, and make whatever it is work
as well as it possibly can. And part of that is driving a
system that is more affordable. So more affordable insurance,
more choice of insurance, insurance that actually gets people
access to providers, so not a meaningless card for them, but
real access, and then finally, insurance that fits their needs
as opposed to what I happen to say they should have. And I want
to work with States like Nevada and others to come up with
different approaches. There is no one size fits all. Also there
is not necessarily one right answer here. This is very complex.
Senator Heller. I agree.
Mr. Azar. We all, on both sides here, we all share the
goal. We want people to have access to affordable insurance
that is better than none. We want to work on that.
Senator Heller. How do you feel about--I am one of the
authors of the Graham-Cassidy-Heller-Johnson bill. Have you
formulated an opinion or a decision on the direction of that or
portions that you do like or perhaps even dislike on that
proposal?
Mr. Azar. So with the Graham-Cassidy-Heller legislation,
the elements of that that are very positive are empowering
States to run their budgets. Right now, the way we run our
Medicaid system for instance, as you know, is the matching
system.
So if the State comes up with more money, things just
increase from the Federal Government. But it also means in
running that program, it is not all their money. So they do not
always exercise the level of creativity or fiscal fraud, waste,
and abuse stewardship over it as if they owned 100 percent of
that money. So I think the incentives can actually be
reoriented in a very positive way by more State empowerment as
you would see through Graham-
Cassidy-Heller.
Senator Heller. In your opening statement, you talked more
about access and competition. And one of the proposals that I
have here in Congress is about competition and access across
State lines. You know, you can get your car insurance, your
house insurance, you can insure anything across State lines
except your health care. You can even get, I guess, your car
insurance from some lizard in Connecticut, the way it works
now.
Have you advocated for this? How do you feel about access
across State lines? I know the President has pushed hard to
allow this kind of competition, this kind of access. And I
think this is the next step. And I think the administration
agrees with that. Just wondering what your opinion was on it.
Mr. Azar. I am supportive of those efforts; frankly, of
anything that can help increase choice. As you said at the
beginning, it is access and choice. The more options available
to patients and consumers of what they can buy, the more likely
they are to find something that is affordable for them and that
works for them.
Senator Heller. I only have a short time left with the
chairman, but what we are looking at is shortage. According to
the Association of American Medical Colleges, there will be a
shortage of more than 150,000 physicians by 2020. What effort
do you anticipate will be needed to cover those shortages?
Mr. Azar. That is a vexing problem. We have programs, of
course, at HHS that help with physician shortages and support
training, whether it is graduate medical education or the
health professions programs, for instance, the tuition subsidy
and reimbursement programs there. Some of those are directed
more towards the underserved areas, the most rural and remote
areas.
I mean, it is just going to be an enduring challenge for
us. I would love your ideas if you have any on how we address
that shortage.
Senator Heller. And I will end with this, Mr. Chairman,
I did introduce legislation last year with Senator Nelson,
called the Residential Physicians Shortage Reduction Act. And I
hope we have a chance and opportunity to take a look at this
legislation which would allow Medicare-supported residency of
over 15,000 in the next 5 years.
So I certainly appreciated all of your help and support,
and I appreciate your chairmanship on this committee. You will
certainly be missed.
Thank you, Mr. Chairman.
The Chairman. Well, thank you, Senator.
Senator Brown?
Senator Brown. Thank you, Mr. Chairman.
Mr. Chairman, thank you for your earlier comments in
support of CHIP. I appreciate that, and I know you were there
at the creation. I hope you can convince Leader McConnell, who
frankly has resisted moving on CHIP September, October,
November, December, and now it is January--I hope you can use
your gravitas and hard work to convince him to do the right
thing.
The Chairman. We will get it done.
Senator Brown. Thank you.
In 2016, 4,000 Ohioans, one of your home States, died from
an opioid overdose, more than any other State in the country.
Eleven people die in my State a day.
You say, if confirmed, one of your top priorities will be
addressing our Nation's opioid epidemic. I am appreciative of
that.
You have said we are in a state of war. My question is,
``yes'' or ``no,'' will you commit to prioritizing this issue?
Mr. Azar. Absolutely.
Senator Brown. Thank you. We obviously need stronger
leadership than we have seen. We need the President more
engaged. We need the Secretary of HHS more engaged.
As part of this comprehensive approach, will you commit to
protecting the integrity of the Medicaid program, including
Medicaid expansion as it currently exists?
Mr. Azar. So, if we look at any kind of changes to
Medicaid, if the Congress were to look at any kinds of changes
to Medicaid, the issue of how we address people who are
suffering from substance abuse who are currently getting
service under Medicaid is obviously something we would have to
look at and meet that need if there is any different structure.
Senator Brown. Okay. Let me stop you there.
I have heard both you and Ms. Verma use the term ``able-
bodied adult'' a lot when speaking about Medicaid. It is clear
that you have both given Medicaid reform and the idea of work
requirements in Medicaid a great deal of thought.
Let me ask you this. Is an individual who has been
diagnosed with severe mental illness or with a substance use
disorder, is that person able-bodied?
Mr. Azar. I do not have a definition in hand. It would be
something we would work out with Congress. I would share your
concern, though. That would seem a pretty obvious----
Senator Brown. So you have no definition of ``able-bodied
adult'' that would be appropriate for differentiating between
and among Medicaid recipients that you can share with us?
Mr. Azar. I just have--philosophically, I would like us to
work in our programs to help avoid any type of cliffs that we
have in benefits to try to smooth out the approaches so that
individuals have an incentive and an ability----
Senator Brown. You can understand--I am sorry to cut you
off. You can understand our skepticism and concern when we hear
top elected officials and appointed officials in this country
talk about able-bodied adults and disqualifying them from
Medicaid.
And then we realize in my State, 200,000 people right now,
200,000 Ohioans are getting Medicaid, are getting opioid
treatment, and getting it because of the Affordable Care Act,
mostly through Medicaid.
I was with a gentleman in Cincinnati at the Talbot House,
sitting next to him and his 30-year-old daughter. He turned to
me and said she would not be alive if it were not for Medicaid.
So you spent 6 years working at HHS, many of those as
General Counsel. You looked at definitions of Medicaid and much
else. You, if confirmed, will be in charge of regulations. That
is why all of us want to know exactly how you could rationalize
requiring individuals struggling with an illness, whether it is
cancer, whether it is opioid addiction, whether it is some kind
of severe mental illness, how you will rationalize requiring
individuals struggling with those illnesses to work in order to
remain eligible, especially when such a requirement is in
direct, in direct contradiction to the objectives of Medicaid
programing.
I mean, if you consider someone with cancer to be able-
bodied, what about an individual diagnosed with depression? I
would like you to do this. I would like you to please submit
your proposed definition of ``able-bodied adult'' to this
committee, to be included in the record of today's hearing
before this committee votes on your confirmation.
Mr. Azar. Senator, I do not have a proposed definition of
able-bodied. You are imputing to me a desire that I have not
stated. I want to work on ways that can make the program
customized to the different types of beneficiaries.
The individuals----
Senator Brown. Again, I apologize----
Mr. Azar [continuing]. That you mention, I have never
singled out and said----
Senator Brown. I understand. I do not question your
motives. I understand that, but I have sat here and seen
members of this committee, all of whom have insurance provided
by taxpayers, trying to strip Medicaid away as my Governor, a
Republican, and I, a Democrat, in my State have fought to keep
Medicaid in place, to keep the expansion in place. Virtually
everybody on the other side of the room here has voted to cut
Medicaid eligibility, to throw many of those 200,000 Ohioans--
200,000 Ohioans right now are getting opioid treatment who get
it because of the Affordable Care Act, and they, getting
government insurance themselves, are willing to take it away.
I apologize, perhaps, but excuse my skepticism that nobody
in your department, Ms. Verma, you--you are not there yet, I
understand--have thought about what the definition of able-
bodied is. Then you will come in here--Senator Nelson's
comments about, you have blown a hole in the budget. This
committee did that. Thank you very much. And we now have to
close that huge hole.
You go after things that generally conservatives do not
like--Medicare, Social Security, Medicaid, unemployment
insurance--to cover this hole. What happens to these people? I
hope, and my time has run out, but I hope that you will think
about those 200,000 people in the State you lived in for part
of your childhood, how they will lose their opioid addiction
treatment coverage if this administration does what it tried to
do earlier.
I know you said President Trump is living up to his promise
not to touch Medicare or Medicaid or Social Security, but the
fact is that he is not, because he wanted to sign a bill that
would strip Medicaid from those 200,000 Ohioans.
And I just need answers for that, Mr. Chairman.
The Chairman. Okay.
Senator McCaskill?
Senator McCaskill. Thank you, Mr. Chairman.
At the company you worked at, Mr. Azar--welcome, by the
way. Thank you for your willingness to serve the public.
Mr. Azar. Thank you.
Senator McCaskill. Which was larger in the last year that
you were in charge, the budget for research and development or
the budget for advertising?
Mr. Azar. The budget for research and development should
have been. I think the budget at Lilly for R&D was
approximately $5 billion out of $20 billion of revenue.
Senator McCaskill. And how much was the budget for
advertising?
Mr. Azar. I do not know the exact number across the board.
It would have been vastly less than $5 billion.
Senator McCaskill. Would you mind getting that figure?
Mr. Azar. No, I would not be able to get you that figure.
That is proprietary information. I have been gone from Lilly
for a year now.
Senator McCaskill. Okay.
Overall, the cost of advertising has dramatically gone up
for pharmaceutical companies in this country. Everybody in
America knows it, because you cannot watch an hour of TV
without being told what you should ask your doctor to prescribe
for you.
Do you believe the American taxpayer should be subsidizing
prescription drug advertising?
Mr. Azar. So I think that consumer advertising can be
helpful where it prods an individual to think about a disease
condition they have, to assess that, as a call to action to
actually address that with a physician.
Senator McCaskill. That is not my question.
Mr. Azar. There is a lot--I share your concern. There is a
lot of drug advertising on television. I share that view. I
want to work----
Senator McCaskill. You know what? I can be thin. I can be
happy. I can even--I mean, the one that kills me is the one for
erectile dysfunction where they have them in two bathtubs. How
crazy is that? That is not happening. I mean, it is nuts.
So I just do not understand why the American taxpayer is
subsidizing this gross overuse of television advertising, not
for, you know, Pepto-Bismol, not for over-the-counter, where
you need information, but rather to tell your doctor you want
it.
Mr. Azar. Of course, we have taxes for business expenses
across the board on so many practices in everything that we do
in business.
I do agree with you, though, that there is a lot of
television and other consumer advertising that does--it does
seem there is so much of it out there, and I would love to work
with Dr. Gottlieb to think at FDA, is our approach in balance
to how we authorize and approve direct-to-consumer advertising?
Is it correct, and do we have data? Is it working, and are
patients taking the right messages from that information?
Senator McCaskill. Oh, it is working. People are--the most
heavily advertised are the most heavily prescribed. It is
working. That is why they are spending so much money on it.
My question is, should taxpayers be helping foot the bill
by it being deductible?
Capitalism--you believe in capitalism.
Mr. Azar. I do.
Senator McCaskill. And you believe in a free market.
Mr. Azar. I do.
Senator McCaskill. And one of the most basic tenants of
free markets is negotiation for prices based on volume,
correct?
Mr. Azar. Yes.
Senator McCaskill. Walmart became the behemoth they are
because they negotiated with their suppliers based on volume to
get lower and lower costs to them, which they then passed on to
the consumer, correct?
Mr. Azar. Yes.
Senator McCaskill. Okay.
You said earlier today that, ``every incentive is towards
higher prices in the pharmaceuticals.'' So do you believe that
negotiation, in fact, would be an incentive to lower prices?
Mr. Azar. So negotiations do lower net prices off of list
price. They do, in fact, and it succeeds quite well I think.
That is absolutely correct.
Senator McCaskill. That would be an incentive. That would
be an incentive that is currently--there is no incentive for
lower prices right now.
Mr. Azar. List prices--that is what is unfortunate. It is
not an incentive on list prices. We have negotiation that pulls
down what the taxpayer pays and what the individual pays.
But that list price, the incentive is towards higher prices
there.
Senator McCaskill. I am very aware there is a lot that goes
on behind the curtain. I am very aware that for most folks who
are getting their drugs, they are getting more and more
expensive, and we do not have the ability in the Federal
Government to negotiate for lower prices based on volume.
Mr. Azar. We actually do.
Senator McCaskill. No, we do not.
Mr. Azar. That is actually--I----
Senator McCaskill. We do not on Medicare Part D.
Mr. Azar. We actually--the largest prescription benefit
programs get the best net pricing of any commercial payers in
the United States. I did that world. I know that world.
Senator McCaskill. Okay.
So what you are saying is, there would be no difference in
the price if we removed the provision in the law that prohibits
the Federal Government from negotiating for lower prices?
Mr. Azar. That is what the Congressional Budget Office,
that is what Peter Orszag has said: you would not get better
pricing by removing that.
Senator McCaskill. That is just crazy. That is just nuts.
Then there is something really wrong with the system.
So what you are telling me with a straight face is, if we
remove the provision that prohibits negotiating for lower
prices, that it is not going to make any difference in the
prices?
Mr. Azar. There is no provision prohibiting negotiating for
lower prices. That is happening right now. The government has
these entities that do that negotiation, and they are----
Senator McCaskill. But they are getting paid to do that.
The government could do it directly.
Mr. Azar. And they would not do any better.
Senator McCaskill. You have all kinds of--and by the way,
would that not save us money?
Mr. Azar. They would not do any better. What we need to do
is----
Senator McCaskill. No, no, no, no. No, there is a middleman
now, Mr, Azar.
Mr. Azar. The issue for patients when they show up at the--
--
Senator McCaskill. There is a middleman now that is doing
that negotiation. It is not the government.
Mr. Azar. Right, and they do it better than the government
would right now.
Senator McCaskill. And the benefit is a government benefit.
So if you take--you are saying because it is private-sector, we
should pay somebody to do it in the middle because the
government cannot do it?
Mr. Azar. What we should be doing is--those techniques that
drive such good net pricing in Part D, what can we take from
the learnings there into Part B? I would focus, if I were you,
on Part B, which is physician-administered drugs, where we pay
sticker price plus a mark-up on that.
Senator McCaskill. Right.
Mr. Azar. With no negotiation out of the government or any
other entity--can we take learnings from how we are actually
managing to be under budget in Part D on our expenses and
managing a program people enjoy, have high satisfaction with,
and take some of those learnings into Part B for taxpayers? And
there, if we can drive prices down, that hits the patient, the
senior citizen out of pocket because they pay, always, a
percent of that Medicare reimbursement for drugs.
Senator McCaskill. I will absolutely work with you on Part
B.
The Chairman. Senator----
Senator McCaskill. But I refuse to acknowledge what you are
saying, and that is--the pharmaceutical industry wanted that in
the law for a reason. They lobbied for it. The guy who helped
get it through went to run pharma after he finished getting it
through.
It was not average consumers who wanted to make sure that
it was illegal to negotiate for lower prices. It was pharma.
And they were powerful, and they did it. I refuse to believe
that they did not want that there for a reason.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator.
Senator Cantwell?
Senator Cantwell. Thank you, Mr. Chairman.
In light of your news of your decision, I wanted to thank
you for your work on the Low-Income Housing Tax Credit, not
just this year but for several years, and making sure that that
program continues to work cost-effectively.
The Chairman. Thank you so much.
Could I make one comment before you begin?
I believe, having listened to Senator Brown's questioning,
I believe Senator McConnell is supportive of our CHIP
agreement. And I hope that our colleagues on the other side,
especially Senator Brown, will help convince Senator Schumer to
support this as well.
Senator Cantwell. He does.
The Chairman. Well, I have not seen it so far. So all I can
say is that I intend to get that done.
Senator Wyden. Mr. Chairman?
The Chairman. Yes?
Senator Wyden. A very few seconds.
I appreciate your interest in getting this done. I spoke on
CHIP on the floor yesterday. Senator Schumer came right after
me and said he was very much committed to our legislation, our
bipartisan legislation.
So thank you for that.
The Chairman. Okay.
Senator Cantwell?
Senator Cantwell. Yes, thank you, Mr. Chairman.
I would be remiss not to mention that I met with my
provider community this weekend on the CHIP issue, and
obviously, the level of anxiety in making sure that we have
continuity, the notices that patients are getting, is starting
to definitely cause anxiety.
But anyway, I wanted to go back to Medicaid, if I could.
Our expansion was over 600,000. And our uninsured rate was cut
by 60 percent. Uncompensated care was slashed.
So to me, the expansion has been a success. Do you support
an end or sunset or curtailing of the Medicaid expansion?
Mr. Azar. So I want to implement the program that we've
got. If we end up looking at any changes on the Affordable Care
Act to Medicaid expansion, I do not believe any of the
proposals that the President or I would support involve cutting
Medicaid or cutting the expansion, but rather slowing the rate
of growth over the next 10 years in the interest of
sustainability.
That is my understanding of the math on that.
Senator Cantwell. So you are saying you actually support
the block-granting?
Mr. Azar. Whether it is block-granting or other changes.
Block-granting--the devil there is in the details of, is there
enough money for the program? Of course, you would have to
figure out appropriate formulas and approaches around what is
the amount of money there.
There is a lot that can appeal from notions of block-
granting, because I do think it helps align incentives better,
where the States have the empowerment and also the
accountability to manage those dollars as their own, and to
really--as Washington State does--really be creative and
customize the use of the program and stretch it for their
citizens.
So I do think there is much that can be appealing.
Senator Cantwell. Listen, I get you are a nominee by this
administration. But I just want to be really clear on this
point, because my State has been really clear on this point.
The proposals that have been considered on block-granting
and a per capita cap, my providers have been very clear--very
clear--they are no innovation. They are simply a budget
mechanism to cut Medicaid. And the CBO saying that it would end
up cutting one-third over the next 2 decades, I think, is
support for that.
So my support of you is going to be based on this, not
because of politics of who you are or any of that. It is going
to be on whether I am casting a vote to continue these policies
or not.
They are working. And my State will be the first--the
first--the first to innovate because we already are, and we had
some conversations about that. So I just want to be clear that
I view the previous proposals of block-granting and a per
capita cap as cuts, as my provider community has made very,
very clear to me.
They have also said that with that kind of approach, they
expect the private market insurance rates to go back up, that
they have seen downward pressure on those prices, given the
expansion. And they do not want to see those go back up.
So another example of that is the delivery system reforms
we were able to do to get the population to move off of long-
term care to community-based care. I am assuming you support
those kinds of efforts as a true way of reforming and driving
down costs.
Mr. Azar. Well, as we spoke in your office, I am completely
supportive of such notions. Sometimes institutional care for
some individuals makes sense, but alternative home-based, other
care, I am completely supportive of these kind of innovations.
Senator Cantwell. So what could we do to drive that to a
faster implementation, because we incented States to do it
under the Affordable Care Act, but if we took a more aggressive
approach, that is where you would really see some savings.
Mr. Azar. Yes, I do not know what the barriers are,
Senator. I do not understand it. It seems so attractive to me.
I do not understand it. So I would love, if confirmed, to get
your ideas. If there are things that HHS is doing that are
getting in the way of that, I would want to know that, because
I am 100-percent committed to where you are on this issue.
Senator Cantwell. Do you support Medicare's move from fee-
for-service to value-based care?
Mr. Azar. I absolutely do. It is one of the four core
priorities that I would try to focus on as Secretary.
Senator Cantwell. And what about the basic health plan
which is part of the--do you support the concept of allowing
some States to bundle up their low-end population and drive
down costs?
Mr. Azar. It seems to me--and I was just delighted to learn
more about it from our meeting. It just seems to me a very
attractive notion of how one helps in that transition between
the Medicaid eligibility and the subsidy elements of the
Affordable Care Act. I want to learn more about it, but it
seems to be very attractive.
Senator Cantwell. Thank you.
Thank you, Mr. Chairman.
The Chairman. Let us see.
Senator Wyden?
Senator Wyden. Thank you very much. Mr. Chairman, I have a
couple questions, but I want to make two unanimous consent
requests, if I might, to put documents into the record at this
point, because I think Mr. Azar has, in response to colleagues,
given incorrect answers.
Senator Nelson, for example, asked whether he was
supportive of the President's position with respect to these
issues: Medicare, Medicaid, or Social Security. Mr. Azar said
that the President promised he would not cut them, and that he
has adhered to that promise. That is simply untrue.
The President's first budget proposed cutting Medicaid by
hundreds of billions of dollars through proposals like block
grants. So I would like to put the budget into the record, not
the entire budget, Mr. Chairman, but the part that indicates
the answer to Senator Nelson's question was incorrect.
Also, we have just gotten information that----
The Chairman. We will be happy to do that, but we should
let Mr. Azar respond to that.
Senator Wyden. This is just a request to put information
into the record.
The Chairman. Your earlier statement--I wonder if he has
any comment about that.
Mr. Azar. I think this has to do with Washington-speak,
that slowing the rate of growth of a growing program is simply
not a cut in my mind or the President's mind.
Senator Wyden. Well, we are talking about hundreds of
billions of dollars, and the State Medicaid directors, point
blank, said no flexibility is going to make up for the fact we
are talking about hundreds of billions of dollars' worth of
cuts.
I also ask unanimous consent, Mr. Chairman, that we put
into the record documents from the Pew Trust and global data
that certainly suggest the answer to Senator McCaskill with
respect to advertising and R&D was incorrect, because in 2013,
according to these documents, Lilly spent $5.7 billion on sales
and marketing and $5.5 billion on R&D. And he said that these
budgets were not remotely close to each other.
The Chairman. Without objection.
[The documents appear in the appendix beginning on p. 170.]
Senator Wyden. I would like those placed in the record.
Let me now, if I could----
Mr. Azar. Mr. Chairman, I would clarify.
The Senator's question was about the advertising budget,
which was about direct-to-consumer, and there is no way that
was even remotely close to $5 billion at Lilly. Not overall
sales, general administrative expenses.
I do not have the balance sheets of Lilly in front of me,
so I cannot speak to that. But I know there is no conceivable
way any advertising budget at Eli Lilly was remotely close to
the R&D spending.
Senator Wyden. We will let people evaluate that data. You
said the two were far apart. That is certainly not what the
documents suggest.
Let me go to my two questions quickly. And I appreciate the
Chairman's thoughtfulness.
Mr. Azar, weeks before at the Senate HELP Committee, you
said that you supported proposals that would wipe out the
Medicaid guarantee for our senior citizens. This is the
guarantee that picks up the tab for two out of three older
people in nursing homes--four thousand seniors in Oregon each
day, and you would wipe out that guarantee by folding Medicaid
into a block grant.
I would like to know whether you still support walking back
the Medicaid guarantee for these older people and, again, as I
indicated, the nonpartisan Medicaid directors stated, ``No
amount of flexibility,'' their words, not mine, ``is going to
compensate for those types of cuts.''
Would you like to walk back your earlier position with
respect to that commitment to older people who did everything
right, that they are still going to have a guarantee of nursing
home coverage?
Mr. Azar. I believe what we talked about at the HELP
Committee hearing was around the fact that I can find a lot of
appeal in block-granting. Now, as I said there and I think I
said here, the devil is in the details on how one structures
the notion of any type of block grant, both in terms of the
dollar amounts and then what strings from the Federal
Government are attached to it, in terms of who needs to be
covered, who is eligible but not necessary to cover.
That all would need to be worked out in legislation, which
we are certainly far from.
Senator Wyden. Why do you not amplify those details for the
record, and, because of the chairman's courtesy, I am going to
do this last one very quickly.
It looks to me like you still want a block grant, though
the State Medicaid directors say no amount of flexibility is
going to be able to compensate for those cuts.
My last question, we have not talked about. That is title
IV-A of Social Security. This is, of course, what people know
as welfare, AFDC, a hugely important program to help families
escape poverty and find work.
Right now, it looks to me like the measure of success is
reducing the caseloads at that program. I would like a
different measure and would like to see if you would work with
us on it. I would like the measure of success to be finding
jobs for people so you can get out of poverty.
So the question is, that is not the measure today. Would
you work with Democrats and Republicans to change the measure,
to actually change the program so that the measure is not
reducing caseloads, but it is having people find work to get
out of poverty? That is a ``yes'' or ``no.''
Mr. Azar. Absolutely.
Senator Wyden. Thank you.
Thank you, Mr. Chairman, for the extra time.
The Chairman. Thank you.
As I understand it, Senator Casey has one question, and
then we will wrap it up.
Senator McCaskill. [Off mic.]
The Chairman. You have one too?
Senator Casey. Mr. Chairman?
The Chairman. Go ahead.
Senator Casey. Thank you very much, Mr. Chairman.
Mr. Azar, I wanted to ask an additional question regarding
the approach the administration has taken with regard to
implementing the Affordable Care Act, making our health-care
system work.
It came to my attention, and I think the attention of
people across the country, from a story in Politico about
efforts made by the administration to, I would argue, sabotage
the Affordable Care Act. I have a report coming out that will
outline some of those actions taken--restricting enrollment is
one, canceling coverage, all kinds of efforts undertaken--that
resulted in us pushing to get a document from Health and Human
Services. It took months to get it.
Now we are told that there is a new document that we
referred to in a letter that we sent December 21st, to Mr.
Hargan, the Acting Secretary. We state, and I am quoting from
the letter, ``HHS has developed a list of hundreds of other
actions to sabotage health care for people nationwide.'' We go
on to say, ``reference a spreadsheet.'' We conclude by saying,
``please provide the spread sheet reference above,'' which
lists more than 200 regulatory actions the administration is
planning to take to further undermine health care. That is our
request.
The response from Health and Human Services on January 5th
said that they will not turn that over. In our HELP Committee
hearing, you said the following when I asked you about
faithfully implementing the Affordable Care Act. You said, ``My
job is to faithfully implement the programs as passed by
Congress, whatever they are. That would include if the
Affordable Care Act is the law of the land and remains such, to
implement it as faithfully as possible.''
So my question is, in light of this recent history, not
theory, history of what I would argue is sabotage, do you
commit to providing that document that I referred to in the
letter sent on the 21st, detailing the more than 200 planned
regulatory actions that was developed and maintained by HHS?
Would you provide that and provide it in a timely manner and
without redactions?
Mr. Azar. I will be happy to look at that. As a nominee, I
cannot, obviously, commit to governmental action. And I do not
know if that document was prepared during the Obama
administration or during the Trump administration. I will be
happy to look at that.
What I can tell you is, if I am confirmed as Secretary, I
am a problem-solver. I want to work with you and every member
of this committee and other committees here to make this
program work for people as best it can.
I do think changes are needed. I think statutory changes
are in the way. But whatever we can do, I want to make
insurance affordable. I want to make it work. I want to get
people enrolled.
Senator Casey. That is great, but--
Mr. Azar. So you have my commitment.
Senator Casey. I appreciate that, but this document was
developed under this administration. More than 200 proposed
actions, and it is hard to square your statement in the HELP
Committee and some other statements today of faithful
implementation with this undermining of the Affordable Care Act
with your support, which is evident from some other questions
about legislation that would further undermine it, especially
on Medicaid.
But I hope that the American people will have the kind of
transparency that they should have a right to expect when it
comes to this kind of sabotage.
Thank you, Mr. Chairman.
The Chairman. Senator Carper?
Senator McCaskill. Thank you. Oh, sorry.
The Chairman. Did you have one more question?
Senator McCaskill. I had questions, yes.
The Chairman. Well let me first go to Senator McCaskill.
Then I am coming to you, Senator Carper. You are going to be
last.
Senator McCaskill. Okay.
Senator Susan Collins and I did a long and thorough
investigation in the Committee on Aging last year on price
spikes. A couple of really good poster children for hedge funds
found a drug that was being sold for pennies, and then they
managed to spike it up until it was thousands and thousands of
dollars.
Have you had a chance to read the report from our
investigation?
Mr. Azar. I have only seen summaries of it, but I do want
to look at that and get any ideas that you all were able to
come up with there that we could do if I am confirmed at HHS to
work on these issues.
Senator McCaskill. I would appreciate that. We spent a lot
of time looking at it. It is obscene. It is really--nobody was
happier when Mr. Wu-Tang was convicted.
Mr. Azar. Senator, one of the things I know that Doctor--I
do not know if you have worked with Dr. Gottlieb on this yet. I
know he is very concerned. There is this issue of these generic
distortions that happen and how can we build more competition
there, and invite it in. I am very committed on that.
Senator McCaskill. Okay.
Do you believe the patent system is being abused?
Mr. Azar. I think there are abuses that happen, absolutely,
Senator.
Senator McCaskill. Okay.
And do you believe that the orphan drug law is being
abused?
Mr. Azar. I do think we need to--I do not know if I want to
call it ``abuse.'' I want to look at it more, because I do not
know enough to use that word. But I know that there are issues
around continued exclusivity across all indications or
expansion where there is an orphan indication.
I want to look at that. It may be simply what the law
provides, in which case, if we do not like that, that is a
legislative question for us as opposed to manipulating a
loophole.
I do not know. I would like to learn more from you about
that.
Senator McCaskill. I would love to work with you on that.
Daranide--last week, it was announced it went from $0 to
$15,000 a bottle. That drug has been around for decades, for
decades. And they just slapped $15,000 on one bottle of it.
Mr. Azar. I would love to work with you to learn more on
that.
Senator McCaskill. There is something really wrong here. I
am going to take you at your word. We are all skeptical over
here because of what we have been through the last 12 months.
Mr. Azar. I hope if I am confirmed, I can earn your trust
and your confidence in my treatment of these issues.
Senator McCaskill. Me too, because drug prices are a huge
problem in the country right now.
Mr. Azar. And I want to work with you, and I hope that a
year from now, you will say, ``You proved me wrong.''
Senator McCaskill. I hope so too.
Thank you, Mr. Chairman.
The Chairman. Thank you.
Senator Carper?
Senator Carper. Would you just briefly tell us who the
folks are right behind you, please?
Mr. Azar. Oh yes, Senator Carper. Thank you very much.
So I am joined by my wife Jennifer, my daughter Claire, my
son Alex, my father, Dr. Alex Azar--who was in Newark, DE when
he worked at DuPont when I was a child growing up--my sister
Stacey, and her husband Mick.
Senator Carper. All right.
Mr. Azar. Thank you, Senator.
Senator Carper. Welcome, one and all. We are glad you are
here.
When I was Governor, one of the things we focused on was,
we set up a family services cabinet council. It involved about
half of my cabinet. We focused for 8 years, from 1993 to 2001,
on the basic building block of our society: families. How do we
strengthen and stabilize families?
We started with a State-wide campaign on teenage pregnancy.
Delaware had one of the highest teen pregnancy rates in the
country.
We put together a bunch of kids from high schools, every
public high school in the State, to tell us what we ought to do
in a comprehensive State-wide approach. And we did it.
The teen pregnancy rate in Delaware is a lot lower now than
it used to be. It is still too high. The unplanned pregnancy
rate in our State, in our country, is still around 50 percent.
Think about that. It is still up around 50 percent.
One of the most reliable forms of contraception available
are something called LARCs, long-acting reversible
contraceptives. They are the most reliable form of
contraception. I think barely 10 percent of all women,
actually, take advantage of inter-uterine devices or implants,
but they work. And they work for a long time. You do not have
to worry about taking them every day or stopping what you are
doing and, you know, getting ready for making children or not.
But in any event, what are the policy and economic barriers
to expanding the use of these long-acting reversible
contraceptives? What specific steps do you think we could take
to expand access to them and lower the rate of unintended
pregnancies in the United States? Again, roughly half of the
pregnancies are unintended. A lot of them are really young
people who are involved.
Mr. Azar. Senator, I am not as knowledgeable there as I
would like to be, and I would love to learn more about it from
you. I am assuming that we provide that through title 10 at
HHS. But if there are barriers, I would love to learn more from
you about that. Obviously, you have studied this issue more
than I have.
Senator Carper. Yes. I am one who believes in going after
root causes. And a lot of times, we have people say the problem
is--one of the big problems we have in our society is poverty.
And I think it was Marian Wright Edelman who used to say
that if you take a 16-year-old girl who is in high school, she
becomes pregnant, has a child, drops out of school, does not
marry the father of her child, there is an 80-percent
likelihood they will live in poverty--80 percent.
The same 16-year-old girl does not become pregnant, does
not drop out of school, waits till 21 to have a child, and
marries the father of the child, the likelihood that that
family will end up in poverty is 8 percent.
Eighty percent on the one hand, 8 percent on the other.
When I found out that, I got serious.
Last year, I think, Massachusetts, under the leadership of
Governor Charlie Baker--very impressive government there, very
impressive leader; you probably know him--they passed
legislation to require all health insurance plans to cover all
forms of birth control without cost sharing. I just want to ask
if--again, this may not be a fair question, but if it is not,
you can say so. But do you agree with the Massachusetts
requirement that all health insurance plans in their State
should cover all forms of birth control without cost sharing?
Mr. Azar. I have no issue with States making those choices.
That is exactly the kind of competition--States making choices
like that--that is what they ought to be doing is making their
choices about how to run their health system.
Senator Carper. All right. Thank you.
When I came in the room Senator McCaskill was asking
questions on drug pricing. And I hope I am not going to cover
the same territory, but let me just ask this question
nonetheless. If you would bear with me, I would appreciate it.
The current administration has repeatedly promised to
tackle high drug prices. They have neglected to back up the
rhetoric with meaningful results, at least to this point in
time.
Several drug companies have tried to address the challenge
of high drug prices with more price transparency and proposals
for value-based pricing. What regulatory and statutory barriers
impede the use of value-based pricing to lower drug costs, and,
as HHS Secretary, how will you bring together the drug
companies, one of which you used to lead, how would you bring
together pharmacy benefit managers, health insurers, other
stakeholders, to put together a value-based drug pricing
proposal that can be implemented quickly to bring some relief
to consumers?
Mr. Azar. So, it is a great question. You put your finger
on one of the key issues, which is value-based pricing. How can
we have outcome-based, value-based--basically pay for the value
that you are getting on the drugs?
One of the biggest barriers is the price reporting
regulations that HHS has. It really has to do with how you
report over time, because of course, you are striking an
agreement and paying for a drug here, but then it might be
several quarters later until you get the data on the results.
And the problem is, then you would end up having a true-up
or a change on past price reporting, which is generally not
viewed as a good thing. So I do believe this is within HHS's
jurisdiction, that if I am there, we can fix that and we can
address that to create pathways where you can really put your
money where your mouth is and support the value on the drug,
and if it does not deliver, then pay more discounting or
rebates in return.
So I actually think this is very actionable, Senator.
Senator Carper. That is great.
I want to commend you on your choice of people to sit up
there with you at the beginning of the hearing: Mike Leavitt,
who succeeded me at the National Governors' Association; Tommy
Thompson from Wisconsin, who preceded all of us as chairman of
the NGA, two of my favorite people. I loved being part of the
NGA, loved being their colleagues. You could not have two finer
people sitting next to you.
I think you have some really good ones sitting behind you
as well. And I would say the one of them who worked at DuPont
for many years--my wife is retired from DuPont, went to work
there over 35 years ago, and had a great career, great career.
We love DuPont in our State, as you might know.
Thanks.
Mr. Azar. Thank you so much.
Senator Carper. Good luck and congratulations.
The Chairman. Okay.
Well, we finally got to the end. I want to thank you for
what I consider to be very elevated testimony. There is no
question in my mind--and there should not be in anybody's
mind--of your competence and your abilities to be able to
handle this very, very important job.
In all the time I have served in the U.S. Senate, I have
worked with HHS and other agencies as well. And I have to say
that you are one of the best public servants whom I have seen
in the whole time that I have been here. And I think you
handled yourself very well in front of this committee, and
hopefully we can get you up and out as soon as we possibly can.
So with that, I just want to welcome your family and thank
them for sitting through this. And I am going to come back and
say ``hello'' to everybody, but God bless you.
And with that, we will recess until further notice.
[Whereupon, at 12:30 p.m., the hearing was concluded.]
A P P E N D I X
Additional Material Submitted for the Record
----------
Prepared Statement of Hon. Alex Michael Azar II, Nominated to be
Secretary, Department of Health and Human Services
I'm pleased to be joined today by my wife Jennifer, my daughter
Claire, my son Alex, and my father Dr. Alex Azar. Unfortunately my
mother, Lynda, could not be here today, and most tragically my step-
mother Wilma passed away just last July from cancer. Thank you all.
Having an opportunity such as this does not happen without family
support and guidance.
Thank you, Mr. Chairman, Ranking Member Wyden, and members of the
committee, for the opportunity to appear before you as the President's
nominee to be the Secretary of Health and Human Services.
Secretary Thompson and Secretary Leavitt, thank you so much for
those kind words and for your friendship and mentorship over the years.
I thank President Trump for the confidence he has bestowed on me.
Ninety-seven years ago, my grandfather--an impoverished teenager
who spoke no English--stepped out of steerage on the S.S. Argentina,
completing his long journey from Amioun, Lebanon, to America. As he
entered the receiving hall at Ellis Island, he met an individual in a
military uniform. That person possessed the power to admit him or to
send him back to poverty and uncertainty. That person was a member of
the United States Public Health Service. It is a testament to all that
I love about this country that just 97 years after my grandfather went
through his 6-
second physical on Ellis Island with no discernable prospects other
than the political, economic, and religious freedom America offers, his
grandson might be in charge of that very Public Health Service, as well
as all of the other world-renowned components of the Department of
Health and Human Services.
The mission of HHS is to enhance and protect the health and the
well-being of all Americans, through programs that touch every single
American in some way, every single day. Through its outstanding leaders
and career staff, HHS is primed to meet that challenge. The task is
humbling. Marshaling and leading the incredible resources of the
Department require innovating, never being satisfied with the status
quo, and anticipating and preparing for the future. I gained these
skills in the dark days after 9/11, as we faced the health and human
consequences of those attacks, through the subsequent anthrax attacks
and preparedness for potential further biological, chemical,
radiological, or nuclear attacks, in the implementation of our
completely novel Part D prescription drug benefit for seniors, by
helping to build global, national, State, and local pandemic flu
preparedness, in our response to threats such as SARS and monkeypox, in
our efforts to continue to reform welfare programs to make them as
modern, responsive, and empowering as possible for the individuals and
families we serve, through innovation in the private sector to bring
life-improving therapies to our people and the people of the world, and
in harnessing the power of big data and predictive analytics to make us
more efficient and more capable of serving our fellow Americans.
With a department the size and scope of HHS, it can be difficult to
prioritize. Nonetheless, should I be confirmed, I do envision focusing
my personal efforts in four critical areas. First, drug prices are too
high. The President has made this clear. So have I. Through my
experience helping to implement Part D and with my extensive knowledge
of how insurance, manufacturers, pharmacy, and government programs work
together, I believe I bring skills and experiences to the table that
can help us address these issues, while still encouraging discovery so
Americans have access to high-quality care.
Second, we must make health care more affordable, more available,
and more tailored to what individuals want and need in their care. We
all share a common concern for our fellow Americans who are struggling
to achieve access to quality health care, even if we do not necessarily
always agree on how best to go about addressing that challenge. Under
the status quo, premiums have been skyrocketing year after year, and
choices have been dwindling. We must address these challenges for those
who have insurance coverage and for those who have been pushed out or
left out of the insurance market by the Affordable Care Act.
Third, we must harness the power of Medicare to shift the focus in
our health-care system from paying for procedures and sickness to
paying for health and outcomes. We can better channel the power of
health information technology, and leverage what is best in our
programs and in the private, competitive marketplace to ensure the
individual patient is at the center of decision making and his or her
needs are being met with greater transparency and accountability.
Finally, we must heed President Trump's call-to-action and tackle
the scourge of the opioid epidemic that is destroying so many
individuals, families, and communities. We need aggressive prevention,
education, regulatory, and enforcement efforts to stop over-prescribing
and overuse of these legal and illegal drugs. And we need compassionate
treatment for those suffering from dependence and addiction.
These are serious challenges that require a serious-minded sense of
purpose, and, if confirmed, I will work with the superb team at HHS to
deliver serious results.
I thank President Trump for this important opportunity to serve the
American people, and I thank you for your consideration of my
nomination.
______
SENATE FINANCE COMMITTEE
STATEMENT OF INFORMATION REQUESTED
OF NOMINEE
A. BIOGRAPHICAL INFORMATION
1. Name (include any former names used): Alex Michael Azar II.
2. Position to which nominated: Secretary of Health and Human
Services.
3. Date of nomination: November 14, 2017.
4. Address (list current residence, office, and mailing addresses):
5. Date and place of birth: June 17, 1967, Johnstown, Pennsylvania.
6. Marital status (include maiden name of wife or husband's name):
7. Names and ages of children:
8. Education (list secondary and higher education institutions, dates
attended, degree received, and date degree granted):
Parkside High School, September 1981-June 1984, High School
Diploma, June 1985 (diploma received after completing required
English course in first year of college; senior year of high
school skipped to attend college).
Dartmouth College, September 1984-June 1988, A.B., June 1988.
Middlebury College Summer School of Arabic, June 1985-August
1985, no degree granted (course credit granted by Dartmouth
College).
Yale Law School, September 1988-June 1991, J.D., June 1991.
9. Employment record (list all jobs held since college, including the
title or description of job, name of employer, location of work, and
dates of employment):
Member, board of directors, HMS Holdings, Inc., Irving, TX,
October 2016-present.
Chairman and founder, Seraphim Strategies, LLC, Indianapolis,
IN, January 2017-present.
President, Lilly USA, LLC, Eli Lilly and Company, Indianapolis,
IN, January 2012-January 2017.
Vice president, managed healthcare services and Puerto Rico,
Lilly USA, LLC, Eli Lilly and Company, Indianapolis, IN, April
2009-December 2011.
Senior vice president, corporate affairs and communications,
Eli Lilly and Company, Indianapolis, IN, June 2007-March 2009.
Deputy Secretary, U.S. Department of Health and Human Services,
Washington, DC, July 2005-February 2007 (Acting Deputy
Secretary from April 2005-July 2005).
General Counsel, U.S. Department of Health and Human Services,
Washington, DC, August 2001-July 2005.
Senior Advisor to the Secretary, U.S. Department of Health and
Human Services, Washington, DC, June 2001-August 2001.
Associate, then partner since January 1999, Wiley, Rein, and
Fielding, Washington, DC, October 1996-June 2001.
Associate Independent Counsel, Office of the Independent
Counsel, Washington, DC, October 1994-September 1996.
Associate, Kirkland and Ellis, Washington, DC, October 1993-
October 1994.
Law clerk to Associate Justice Antonin Scalia, Supreme Court of
the United States, Washington, DC, July 1992-July 1993.
Law clerk to Circuit Judge J. Michael Luttig, U.S. Court of
Appeals for the Fourth Circuit, McLean, VA, October 1991-June
1992.
Law clerk to Circuit Judge Alex Kozinski, U.S. Court of Appeals
for the Ninth Circuit, Pasadena, CA, July 1991-August 1991.
Summer associate, Steptoe and Johnson, Washington, DC, June
1991-June 1991.
Summer associate, Sullivan and Cromwell, New York, NY, July
1990-August 1990.
Summer associate, Steptoe and Johnson, Washington, DC, June
1990-July 1990.
Volunteer extern to Circuit Judge Alex Kozinski, U.S. Court of
Appeals for the Ninth Circuit, Pasadena, CA, June 1989-August
1989.
10. Government experience (list any advisory, consultative, honorary,
or other part-time service or positions with Federal, State, or local
governments, other than those listed above):
Member, board of directors, Indianapolis Airport Authority,
Indianapolis, IN, January 2009-December 2012.
Ex officio United States member of the U.S.-Ireland Research
and Development Steering Committee, Washington, DC, July 2005-
February 2007.
Ex officio member of the United States Architectural and
Transportation Barriers Compliance Board, Washington, DC,
August 2001-July 2005 (General Counsel sits as Federal member
for the U.S. Department of Health and Human Services).
Volunteer intern, Health and Income Maintenance Division,
Office of Management and Budget, Washington, DC, March 1986-
June 1986.
11. Business relationships (list all positions held as an officer,
director, trustee, partner, proprietor, agent, representative, or
consultant of any corporation, company, firm, partnership, other
business enterprise, or educational or other institution):
Member, board of directors and chairman of the Strategic
Planning Committee (since 2015), American Council on Germany,
New York, NY, December 2010-present.
Member, board of directors and member of the Audit Committee,
Indianapolis Symphony Society, Indianapolis, IN, November 2008-
present.
Biotechnology Innovation Organization (BIO), Washington, DC,
April 2013 to January 2017. Member of the board of directors.
Member of the executive committee of the board (since 2016).
Member of the health section governing board. Co-chairman of
the board, Standing Committee on Reimbursement. Member of the
Regulatory Environment Committee and the Intellectual Property
Committee.
Healthcare Leadership Council, Washington, DC, January 2008 to
January 2017. Member of the board of trustees. Treasurer (since
2013) and member of the executive committee of the board of
trustees (since 2012).
Yale Law School Association, New Haven, CT, 2010 to 2013,
member. Vice president of the executive committee of the
association, elected to 3-year term (2011 to 2013).
Indianapolis Airport Authority, Indianapolis, IN, January 2009
to December 2012. Member of the board of directors. Chairman of
the Human Resources Committee (since 2010). Appointed by the
Mayor of Indianapolis.
National Association of Manufacturers, Washington, DC, March
2008 to 2012. Member of the board of directors.
Health Coverage Foundation, Washington, DC. Member of the board
of directors of a non-profit foundation dedicated to assisting
the uninsured in obtaining health-care coverage in the private
marketplace, providing premium assistance, and educating the
public on the availability for such coverage (January 2008 to
December 2011).
The Eli Lilly and Company Foundation, Inc., Indianapolis, IN.
Ex officio member of the board of directors of the foundation,
which is a tax-exempt private foundation created by Eli Lilly
and Company that awards cash grants to support philanthropic
initiatives that are aligned with the company's business
strategy, including a discretionary grants program, the
employee matching gifts program, and the employee volunteer
recognition program (June 2007 to March 2009).
12. Memberships (list all memberships and offices held in
professional, fraternal, scholarly, civic, business, charitable, and
other organizations):
Bar of the Supreme Court of the United States (November 1999 to
present).
Bar of the Court of Appeals of Maryland (December 1993 to
present).
Bar of the District of Columbia Court of Appeals (April 1995 to
present).
Bar of the U.S. Court of Appeals for the District of Columbia
Circuit (January 1994 to present).
Bar of the U.S. Court of Appeals for the Fourth Circuit
(January 1994 to present)
Bar of the U.S. District Court for the District of Maryland
(March 1994 to present).
Bar of the U.S. District Court for the District of Columbia
(November 1999 to present).
Maryland State Bar Association (1993 to present, except I do
not believe I was a member of this voluntary association for
fiscal years 1994-1995, 1997-1998, 2000-2002, and 2008-2009).
The Mory's Association (Yale University affiliated dining
club), member, New Haven, CT (approximately 1990 to present).
The Cosmos Club, non-resident member, Washington, DC (January
2006 to present).
Meridian Hills Country Club, member, Indianapolis, IN (August
2007 to present).
The Chevy Chase Club, non-resident member, Chevy Chase, MD
(October 2017 to present).
Saint George Antiochian Orthodox Church, member, Fishers, IN
(August 2007 to present), altar server (August 2007 to
present), chairman of the Prison Ministry Committee
(approximately 2010 to 2011).
Order of St. Ignatius, life member, Antiochian Orthodox
Archdiocese of North America (November 2016 to present).
The Zetema Project, panelist (January 2017) and contributor
(current), San Francisco, CA.
Center for Corporate Innovation, Inc. (CCI), member, Los
Angeles, CA (January 2015 to present).
Honorary advisory boards:
Indiana University School of Medicine External Advisory Board,
member, Indianapolis, IN (2008 to November 2010).
George Mason University School of Law board of advisors,
member, Arlington, VA (joined December 2008 and do not know if
still in existence; I have never participated in any meetings
and do not consider myself a member). The Texas Review of Law
and Politics honorary board of advisors, member, Austin, TX
(2001 to March 2005)
Voluntary legal professional memberships:
American Health Lawyers Association, member, Washington DC
(2001 to approximately 2007).
American Bar Association, member (1998 to 2016), executive
branch liaison to the Administrative Law Section (August 2006
to February 2007), Washington, DC.
The Federalist Society for Law and Public Policy, member
(September 1988 to 2007). Member of the National Practitioners
Advisory Council (joined December 2008, but never participated
on calls or in meetings; I am informed this group has been
inactive for at least 4-5 years). Vice chairman of the
Federalism and Separation of Powers Practice Group (June 1997
to December 1999). Chairman-elect of the Federalism and
Separation of Powers Practice Group (January 2000 to June
2001), Washington, DC.
The Federalist Society for Law and Public Policy, Yale Law
School chapter, member (September 1988 to June 1991) and vice
president (approximately September 1990 to June 1991), New
Haven, CT.
The Becket Fund for Religious Liberty, chairman of the Lawyers'
Council, Washington, DC (February 1998 to June 2001).
Federal Bar Association, member, Washington, DC (approximately
1993 to 1998).
American Judicature Society, member, Washington, DC
(approximately 1993 to 2000, with various periods when not a
member).
College and law school associations:
Yale Law School class of 1991, member of various reunion gift
committees (most recently in 2016). Currently leading efforts
to raise money to pay for portrait of Associate Justice Sam
Alita, New Haven, CT.
Dartmouth College class of 1988. May have been member of
various reunion gift committees (most recently might have been
2013); conducted alumni interviews of candidates in central
Indiana (2015 to 2016), Hanover, NH.
Yale Law Journal, member (1989 to 1991) and executive committee
member (April 1990 to June 1991), New Haven, CT.
Religious memberships:
Saints Peter and Paul Antiochian Orthodox Church, member (April
1999 to July 2007) and parish council member (January 2001 to
December 2003), Potomac, MD.
Saint John's Episcopal Church, member (approximately 1993 to
February 1999). Christian education committee member
(approximately 1996 to February 1999). Acolyte program director
(approximately 1994 to February 1999). Chalice bearer
(approximately 1994 to February 1999), Washington, DC.
Episcopal Church at Yale, member (September 1988 to June 1991)
and chalice bearer (approximately 1990 to June 1991), New
Haven, CT.
Other organizations:
Indianapolis Museum of Art, Indianapolis, IN. Member of the
nominating committee for the board of governors (2008 to 2009)
(I assisted the board and CEO in identifying candidates for
selection to the board, but was never myself a member of the
board).
Rollingwood neighborhood association, member, Chevy Chase, MD
(December 1997 to August 2007).
Rock Creek Pool, Inc., summer member, Chevy Chase, MD
(approximately 1999 to August 2007).
Over the years, I have been simply a dues-paying member of
various organizations, such as the U.S. Equestrian Federation,
the Brown County Art Guild, the Indianapolis Children's Museum,
the Smithsonian Institution, the Indianapolis Zoo, the National
Zoo, the Art Institute of Chicago, the Hoosier Salon, and the
Indiana Plein Air Painters Association. There may be similar
additional such memberships I do not presently recall.
13. Political affiliations and activities:
a. List all public offices for which you have been a
candidate.
None.
b. List all memberships and offices held in and services
rendered to all political parties or election committees during
the last 10 years.
During the 2008 campaign, I believe I may have been a nominal
member of a campaign constituency group called Arab Americans for
McCain. I may also have signed up for Lawyers for McCain, but do not
recall.
During the 2012 campaign, I served on a campaign policy working
group on health-care policy for the Romney campaign. I believe I
participated in a few conference calls and email exchanges.
During the 2016 campaign, I was a member of the Indiana State
steering committee for Jeb Bush. I later was listed as one of many
Indiana State co-chairs for Ted Cruz. Both positions were honorific and
entailed no activity or fundraising. At some point prior to the
election, I believe I agreed to assist the Trump/Pence campaign
transition team with regard to health policy, but do not recall any
active engagement, calls, or meetings.
I was a co-host, along with Lilly's CEO, of a fundraiser for
Indiana Speaker of the House Brian Bosma on October 1, 2014. I was
listed as a host for a Dan Coats for Senate fundraiser on June 22,
2010, by virtue of a contribution I previously gave. I do not remember
serving on any other political organizations during this period,
although while a senior executive at Eli Lilly, on occasion, I reached
out to other executives to contribute to political fundraisers or to
the Lilly PAC.
c. Itemize all political contributions to any individual,
campaign organization, political party, political action
committee, or similar entity of $50 or more for the past 10
years.
Friends of Todd Young, Inc. November 7, 2016 $2,500
TENNPAC August 29, 2016 $2,500
Committee to Elect Brian Bosma August 29, 2016 $1,000
Trump Victory July 12, 2016 $2,700
Jackie Walorski for Congress April 22, 2016 $500
Indiana Republican Party April 21, 2016 $200
Committee for Najjar for Judge March 20, 2016 $500
Friends of Todd Young, Inc. March 18, 2016 $1,500
Portman for Senate Committee March 18, 2016 $2,000
Indiana Republican Party December 7, 2015 $2,000
Jeb 2016, Inc. October 8, 2015 $2,700
Mike Pence for Indiana Committee October 2, 2015 $1,000
Friends of Todd Young, Inc. June 21, 2015 $1,000
Brooks-Bucshon Joint Fundraising June 7, 2015 $1,000
Committee
Stutzman for Congress November 3, 2014 $500
Bucshon for Congress November 3, 2014 $500
Susan Brooks for Congress November 3, 2014 $500
Committee to Elect Brian Bosma October 6, 2014 $1,000
Luke Messer for Congress September 30, 2014 $500
Dan Coats for Indiana September 30, 2014 $1,000
Friends of Connie Lawson June 4, 2014 $250
Ben Sasse for Nebraska May 9, 2014 $1,000
McConnell Senate Committee 2014 April 19, 2014 $2,100
Friends of Todd Young March 25, 2014 $1,000
Walorski for Congress March 20, 2014 $500
McConnell Senate Committee 2014 April 26, 2013 $500
Dan Coats for Indiana December 6, 2012 $500
Mike Pence for Indiana October 24, 2012 $200
Sue Ellspermann for Lt. Governor October 15, 2012 $250
Hoosiers for Richard Mourdock, Inc. October 15, 2012 $500
Romney Victory, Inc. September 6, 2012 $2,500
Ted Cruz for U.S. Senate September 4, 2012 $500
Friends of Todd Young September 4, 2012 $500
Todd Rokita for Congress September 4, 2012 $500
Todd Rokita for Congress June 28, 2012 $500
Stutzman for Congress June 14, 2012 $500
Hatch Election Committee June 7, 2012 $1,000
Bucshon for Congress May 6, 2012 $500
Wendy Long for New York April 14, 2012 $500
Luke Messer for Congress April 14, 2012 $500
Tommy Thompson for Senate, Inc. March 13, 2012 $2,500
Friends of Dick Lugar November 6, 2011 $500
Dan Coats for Indiana October 26, 2011 $500
Mike Pence for Indiana October 20, 2011 $2,500
David McIntosh for Indiana September 28, 2011 $2,500
Romney for President, Inc. September 23, 2011 $2,500
Greg Ballard for Mayor Committee June 30, 2011 $2,000
Jackie Walorski for Congress June 30, 2011 $1,000
Marion County Republican Central June 9, 2011 $100
Committee
Hoosiers for Rokita October 24, 2010 $500
Aiming Higher October 10, 2010 $1,000
Aiming Higher September 23, 2010 $1,000
Friends of Todd Young September 8, 2010 $250
Dan Coats for Indiana September 1, 2010 $2,400
Mike Pence Committee August 18, 2010 $500
Mark Massa for Prosecutor August 4, 2010 $250
Dan Coats for Indiana March 29, 2010 $2,400
Hershman for Congress March 29, 2010 $500
Brett Davis for Lieutenant Governor January 5, 2010 $100
Sam Saad for City Council January 5, 2010 $100
The Scott Brown for U.S. Senate January 15, 2010 $500
Committee
Teresa Lubbers for State Senate October 21, 2008 $100
Committee
Mike Murphy Committee October 21, 2008 $100
Committee to Elect Brian Bosma October 21, 2008 $100
Zoeller for Attorney General October 21, 2008 $100
JonElrod.com Committee October 21, 2008 $100
Marion County Republican Central October 21, 2008 $100
Committee
Mitch for Governor Campaign October 10, 2008 $500
Hoosiers for Buyer October 10, 2008 $500
Indiana Republican Party October 7, 2008 $300
National Republican Senatorial September 30, 2008 $1,000
Committee
McGoff for Congress April 24, 2008 $100
McConnell Senate Committee 2008 March 25, 2008 $2,300
John McCain 2008 February 13, 2008 $2,300
From December 15, 2007, until January 31, 2017, I had $208 per pay
period (2 pay periods per month) withdrawn as a contribution to the
Lilly PAC.
14. Honors and awards (list all scholarships, fellowships, honorary
degrees, honorary society memberships, military medals, and any other
special recognitions for outstanding service or achievement):
Surgeon General's Medallion.
Phi Beta Kappa Society, Dartmouth College.
Nelson A. Rockefeller Memorial Fellowship for ``Honors thesis
of such scholarly merit that it shows promise of publication,''
Dartmouth College.
Colby Government Prize for ``excellence in the Government
major,'' Dartmouth College.
Rockefeller Prize in Comparative Politics for ``outstanding
thesis in the field of comparative politics,'' Dartmouth
College.
Rockefeller Public Service Internship Grant, Dartmouth College.
High Honors Rufus Choate Scholar, Dartmouth College.
Saint Peter's Church Van der Bogart Scholar, Salisbury, MD.
Special Achievement Award, Office of the Independent Counsel.
15. Published writings (list the titles, publishers, and dates of all
books, articles, reports, or other published materials you have
written):
Alex M. Azar II, Note, ``FIRREA: Controlling Savings and Loan
Association Credit Risk Through Capital Standards and Asset
Restrictions,'' 100 Yale Law Journal 149 (1990).
Alex M. Azar II, ``Recommended Reading: Antonin Scalia's A
Matter of Interpretation: Federal Courts and the Law,'' The
Federalist Paper, May 1997.
Alex M. Azar II, ``The Appellate Corner,'' Criminal Law and
Procedure News, Federalist Society for Law and Public Policy
Studies Criminal Law and Procedure Practice Group, Fall 1996,
Spring 1997, Fall 1997, Winter 1998, Spring 1999.
Alex M. Azar II, Letter to the Editor, ``The Cipro Dilemma,''
American Lawyer, January 31, 2002.
Alex M. Azar II, ``What a Food and Drug Lawyer Should Know
About the Medicare Modernization Act,'' 59 Food and Drug Law
Journal 217 (2004).
Alex M. Azar II, ``Administrative Law Meets Health Law:
Inextricable Pairing or Marriage of Convenience?'', 49 St.
Louis University Law Journal 35 (2004).
Alex M. Azar II, ``The Role of Intellectual Property Protection
in the United States to Yield Both Public Health and National
Wealth: Customary Coordination Between the Private Sector and
the U.S. Department of Health and Human Services Realizing the
Common Good,'' The Forum for EU-U.S. Legal-Economic Affairs,
Amsterdam Forum, The Netherlands (The Mentor Group, Boston,
Mass.), May 2005, at 41.
Alex M. Azar II, ``Cracks in the System: The Adequacy of the
U.S. Health Care Regulation in a Global Age,'' 58
Administrative Law Review 551 (2006).
Alex M. Azar II, ``Eating Today and Eating Tomorrow:
Competition, Innovation, and Pricing for Modern Medicine,'' The
Ripon Society's Congressional Advisory Board: Public Policies
for Debate 2006 (The Ripon Society, Washington, DC), 2006, at
7.
Alex M. Azar II, ``What is Your Health Worth to Your
Bureaucrat?'', The Forum for EU-US Legal-Economic Affairs,
Vienna Forum, Austria (The Mentor Group, Boston, MA), 2006, at
1.
Alex M. Azar II, Panelist Remarks from Panel, ``Intellectual
Property: Does IP Harm or Help Developing Countries,''
Proceedings of the 2006 National Lawyers Convention, Engage,
Vol. 8, Issue 2 (The Federalist Society for Law and Public
Policy Studies, Washington, DC), 2006, at 80.
Alex M. Azar II, ``Transparency in Health Care: What Consumers
Need to Know,'' Heritage Lectures, No. 986 (The Heritage
Foundation, Washington, DC), January 22, 2007, at 1.
Alex M. Azar II, ``We Have to Innovate for Desired Patient
Outcomes,'' Medical News (www.medicalnews.md), November/
December 2007, at 5.
Alex M. Azar II, ``Taking the Strain,'' Interview with Alex M.
Azar II, The House Magazine, Tuberculosis Supplement, March 24,
2008.
Alex M. Azar II, ``The Importance of HIT,'' Prescriptions for
Excellence in Health Care, a Collaboration between Jefferson
Medical College and Eli Lilly and Company, Issue 3, Spring
2008.
Alex M. Azar II, ``Health Information Technology: A Priority
for Patients, for Physicians, and for Lilly,'' Prescriptions
for Excellence in Health Care, a Collaboration between
Jefferson Medical College and Eli Lilly and Company, Issue 4,
Summer 2008.
Alex M. Azar II, ``Keeping the Patient in the Center of Health
Reform,'' Inside ALEC, a Publication of the American
Legislative Exchange Council. November/December 2008.
Alex M. Azar II, ``Generic Medicines: The Gift of Innovation,''
reprinted in Vital Speeches of the Day, December 2008, at 559.
Alex M. Azar II, ``Health Chief Can Make Her Mark by
Prioritizing,'' Indianapolis Star, March 15, 2009, at B9.
Alex M. Azar II, ``Generic Medicines: The Gift of Innovation,''
reprinted in Contemporary American Speeches, by Richard
Johannesen, et al. (2011), at 36.
Alex M. Azar II, ``A Letter,'' in The 4 Disciplines of
Execution: Achieving Your Wildly Important Goals, by Chris
McChesney, Sean Covey, and Jim Huling (Free Press 2012), at
xxv.
Alex M. Azar II, ``Inheritance From Hugo Chavez: How Not To Fix
Healthcare,'' Real Clear Markets, http://
www1.realclearmarkets.com/printpage/?url= http://
www.realclearmarkets.com/articles/2014/02/25/
inheritance_from_hugo
_chavez_how_not_to_fix_healthcare__100923.html, February 25,
2014.
Alex M. Azar II, ``If We Love U.S. Jobs, We Must Love Tax
Competition,'' Real Clear Markets, http://
www.realclearmarkets.com/articles/2014/04/25/if_we_
love_us_jobs_we_must_love_tax_competition_101019.html, April
25, 2014.
Alex M. Azar II, ``A Few Simple Fixes Could Unleash an Economic
Boom,'' Real Clear Markets, http://www.realclearmarkets.com/
articles/2015/04/29/a_few_
simple_fixes_could_unleash_an_economic_surge_101647.html, April
29, 2015.
Alex M. Azar II, ``What's Behind the Surge of Healthcare
Consolidations?'', Real Clear Markets, http://
www.realclearmarkets.com/articles/2015/06/29/whats_
behind_the_surge_of_healthcare_consolidation.html, June 29,
2015.
Alex M. Azar II, ``Will Healthcare Experience a `Retail
Revolution'?'', Real Clear Markets, http://
www.realclearmarkets.com/articles/2015/11/09/will_health
care_experience_a_retail_revolution_101880.html, Nov. 9, 2015.
Alex M. Azar II, ``A Dose of Patience Needed to Make
Personalized Medicine a Reality for All Patients,''; BIO Buzz
Official Show Daily, June 8, 2016, at 10.
There may be older publications that I do not now recall or
have copies of.
16. Speeches (list all formal speeches you have delivered during the
past 5 years which are on topics relevant to the position for which you
have been nominated):
Acceptance of the John J. McCloy Award, American Council on
Germany 21st Annual McCloy Awards Dinner, New York, New York,
June 11, 2013.
Opening remarks, American Council on Germany Policy Conference
on ``A Transatlantic Trade and Investment Partnership: Can the
United States and Europe Lead the Way to Global Economic
Recovery?'', New York, New York, June 12, 2013.
Panelist, Indianapolis Business Journal Power Breakfast Series,
``Health Care and Benefits,'' Indianapolis, Indiana, September
25, 2013 (no prepared remarks).
Keynote address, ``Personalized Medicine: The Big Picture,''
MIT Sloan BioInnovations 2014, Precision Medicine and the
Impact of Innovation on Targeted Care, Cambridge,
Massachusetts, February 28, 2014. Video available at: https://
youtu.be/XqA8nPVuk64.
Panelist, ``The Rise of the Patient: Re-Imagining the Health
Care Ecosystem,'' The Economist Health Care Forum 2014: A
Global Business in Flux, Boston, Massachusetts, September 17,
2014 (no prepared remarks).
Panelist, ``Bigger and Better? Horizontal Consolidation Within
Sectors and Antitrust Enforcement,'' Solomon Center for Health
Law and Policy at Yale Law School, New Haven, Connecticut,
November 13, 2015 (no prepared remarks). Video available at:
https://youtu.be/7pfXioj9beY.
Inaugural keynote address, ``Succeeding on Purpose: Why
Institutions That Provide Purpose to Their Staff and Customers
Are Winning Today,'' Dr. Nicholas R. Blanchard Annual
Healthcare Symposium, University of Maryland Eastern Shore,
Princess Anne, Maryland, April 13, 2016. Video available at:
https://youtu.be/JQLvyLNhja4.
Panelist, ``Pharmacoeconomics: R&D Strategies in an Era of Drug
Pricing Controversy,'' FierceBiotech Executive Breakfast at
BIO2016, San Francisco, California, June 7, 2016 (no prepared
remarks).
Panelist, ``Educational Series on Affordable Medicines: Value-
Based Payments and Financing Breakthrough Treatments,''
Bipartisan Policy Center, Washington, DC, June 16, 2016 (no
prepared remarks). Video available at: https://
bipartisanpolicy.org/events/educational-series-on-affordable-
medicines-value-based-payments/.
Address, ``Join Me on the Frontier,'' Leadership Dinner,
American Legislative Exchange Council, Indianapolis, Indiana,
July 26, 2016.
Case study presentation, ``Using Behavioral Economics to
Improve Patient Adherence,'' Center for Corporate Innovation,
Inc., DC Healthcare Summit, Washington, DC, August 4, 2016 (no
prepared remarks; PowerPoint provided).
Dinner address, ``Succeeding on Purpose: Why Providing Purpose
Is Key to Winning Today,'' Indiana Healthcare Executives
Network, Indianapolis, Indiana, September 7, 2016.
Keynote presentation, ``Demonstrating the Value of Medicines,''
Common Problems in Arrhythmia Management: A Case-Based
Approach, Carmel, Indiana, September 23, 2016.
Panelist, ``Health Law, Policy, Politics, and Progress: What
Lies Ahead,'' Yale Law School Alumni Weekend 2016, New Haven,
Connecticut, October 22, 2016 (no prepared remarks).
Keynote address, ``Prescription for Value: Keeping Innovation
Affordable for Patients,'' Manhattan Institute Health Care
Symposium, New York, New York, November 3, 2016.
Panelist, ``Large Biotech and Pharma Perspectives: Takeaways
From Last Year,'' Boston Biotech Conferences, East/West CEO
Conference, San Francisco, California, January 7, 2017 (no
prepared remarks).
Discussion starter, ``Medicare as a Public-Private Program:
Lessons Learned,'' The Roles of Government and the Private
Sector: Markets, Regulation, Responsibility and Risk, The
Zetema Project, Chattahoochee Hills, Georgia, January 19, 2017
(no prepared remarks).
Guest lecturer, ``Present and Future Directions of the U.S.
Healthcare Ecosystem,'' Healthcare Initiative at Tuck, Tuck
School of Business, Dartmouth College, Hanover, New Hampshire,
February 9, 2017 (no prepared remarks).
Panelist, ``Policy Outlook--ACA, CMS, PDUFA VI and the Trump
Administration,'' BIO CEO and Investor Conference, New York,
New York, February 14, 2017 (no prepared remarks).
Moderator, closing keynote, ``Healthcare Debate Featuring Karl
Rove and Howard Dean,'' MedImpact 2017 Annual Conference,
Coronado, California, March 10, 2017 (no prepared remarks).
Keynote, ``Industry Perspective, a Fireside Chat,'' Veeva
Global Commercial and Medical Summit, Philadelphia,
Pennsylvania, May 8, 2017 (no prepared remarks). Video
available at: https://www.veeva.com/resources/industry-
perspective-fireside-chat-matt-wallach-and-alex-azar/.
Keynote Address, ``Specialty Pharmacy: The Bridge to the
Patient in a Rapidly Evolving Healthcare Ecosystem,'' 5th
Annual National Association of Specialty Pharmacy Annual
Meeting and Educational Conference, Washington, DC, September
19, 2017 (no prepared remarks; PowerPoint provided).
Dinner address, ``Leadership Lessons From a Life in Law,
Government, and Business,'' Class of 2016 Current Issues in the
Business of Medicine Speaker Series, Business of Medicine
Physician MBA Program, Indiana University Kelley School of
Business, Indianapolis, IN, October 13, 2017 (no prepared
remarks).
I have not included informal remarks and discussions and
internal Lilly presentations.
17. Qualifications (state what, in your opinion, qualifies you to
serve in the position to which you have been nominated):
I would be deeply honored to return to the U.S. Department of
Health and Human Services to help lead the dedicated team
there. In 2001, I became the General Counsel of the Department
of Health and Human Services. In that role and in my subsequent
role as Deputy Secretary of Health and Human Services, I
developed a deep sense of mission and purpose to help people
live longer, healthier, happier lives. With almost 6 years of
experience at the highest levels of HHS playing key roles
during the attacks on September 11th, the subsequent anthrax
attacks, public health preparedness for potential smallpox
attack, the SARS and monkeypox crises, implementation of
Medicare Part D and the Medicare Advantage program, the
Hurricane Katrina response and recovery, the Office of Refugee
Resettlement of Americans from Lebanon, the global public
health preparedness efforts, the creation and implementation of
Project Bioshield and other efforts to develop and acquire
chemical, biological, radiological, and nuclear
countermeasures, public health emergency preparedness and
planning efforts in the United States, and the pandemic avian
influenza preparedness program, as well as the day-to-day
operations of HHS, I would bring a unique level of experience
and knowledge to the role of Secretary. I believe this deep
knowledge and experience at HHS, combined with my years of
experience in the private sector leading large organizations
and delivering results would enable me to help HHS and its
dedicated career professionals deliver on their critical
mission of improving the lives and well-being of every
American.
B. FUTURE EMPLOYMENT RELATIONSHIPS
1. Will you sever all connections with your present employers,
business firms, associations, or organizations if you are confirmed by
the Senate? If not, provide details.
Yes.
2. Do you have any plans, commitments, or agreements to pursue
outside employment, with or without compensation, during your service
with the government? If so, provide details.
No.
3. Has any person or entity made a commitment or agreement to employ
your services in any capacity after you leave government service? If
so, provide details.
No.
4. If you are confirmed by the Senate, do you expect to serve out
your full term or until the next presidential election, whichever is
applicable? If not, explain.
Yes.
C. POTENTIAL CONFLICTS OF INTEREST
1. Indicate any investments, obligations, liabilities, or other
relationships which could involve potential conflicts of interest in
the position to which you have been nominated.
The U.S. Office of Government Ethics (``OGE'') and the HHS
Ethics Office have reviewed my financial holdings, outside
positions, and my existing agreements and arrangements. I have
agreed to take all of the actions that they have requested in
order to resolve any actual or apparent conflict of interest.
The specific actions I agreed to take are detailed in the
ethics agreement I have signed and submitted to the HHS
Designated Agency Ethics Official (``DAEO'').
I will follow the law and the administration's conflict of
interest policies and recuse myself as required. I will consult
with the HHS Ethics Office as needed and will follow the advice
of the HHS DAEO, a career civil service employee, regarding my
recusal obligations.
2. Describe any business relationship, dealing, or financial
transaction which you have had during the last 10 years, whether for
yourself, on behalf of a client, or acting as an agent, that could in
any way constitute or result in a possible conflict of interest in the
position to which you have been nominated.
The U.S. Office of Government Ethics (``OGE'') and the HHS
Ethics Office have reviewed my financial holdings, outside
positions, and my existing agreements and arrangements. I have
agreed to take all of the actions that they have requested in
order to resolve any actual or apparent conflict of interest.
The specific actions I agreed to take are detailed in the
ethics agreement I have signed and submitted to the HHS DAEO.
I will follow the law and the administration's conflict of
interest policies and recuse myself as required. I will consult
with the HHS Ethics Office as needed and will follow the advice
of the HHS DAEO regarding my recusal obligations.
I was employed by Eli Lilly and Company or its U.S. affiliate,
Lilly USA, LLC, for most of the past 10 years, leaving at the
end of January 2017. I continue to participate in the Eli Lilly
and Company Defined Benefit Plan, which has both qualified and
nonqualified components; however, I am owed no other payments,
participate in no other benefit programs, and hold no equity
interests in Eli Lilly and Company. I have agreed to take all
of the actions that OGE and the DAEO have requested in order to
resolve any actual or apparent conflict of interest regarding
Lilly, which are set forth in my ethics agreement. I will
consult with the HHS ethics office as needed and will follow
the advice of the DAEO regarding my recusal obligations.
Since October 2016, I have been a member of the board of
directors of HMS Holdings, Inc., which provides cost
containment solutions in health care to help payers improve
performance. As set forth in my ethics agreement, I will resign
from the board of HMS Holdings, Inc., and divest my equity
interests in HMS. I will consult with the HHS ethics office as
needed and follow the advice of the HHS DAEO regarding my
recusal obligations.
From January 2017 to present, I have been the chairman and
founder of Seraphim Strategies, LLC. I am the only member and
employee. If I am confirmed, this LLC will be inactive during
the period of my appointment and will not advertise. I will not
perform any services for this entity, except that I will comply
with any requirements involving legal filings, taxes, and fees
that are necessary to maintain the entity while it is in
inactive status. I will consult with the HHS Ethics Office as
needed and will follow the advice of the HHS DAEO regarding my
recusal obligations.
Through Seraphim Strategies, LLC, I was retained to provide a
modest amount of consulting advice to UCB, Inc., Edwards
Lifesciences, and the National Pharmaceutical Council. In
addition, through Seraphim Strategies, LLC, I was retained by
my speaker's bureau, World Wide Speakers Bureau, to deliver
paid speeches or host debates at meetings held by MedImpact,
the National Association of Specialty Pharmacy, and Veeva
Systems. Also through Seraphim Strategies, LLC, I was
independently retained by CCI, Inc., to deliver paid remarks.
As to each of these entities, I will have no continuing
relationship or financial connection, and I will consult with
the HHS Ethics Office as needed and follow the advice of the
HHS DAEO regarding my recusal obligations.
As noted, I served on the boards of the Biotechnology
Innovation Organization and the Healthcare Leadership Council
and will consult with the HHS Ethics Office as needed and
follow the advice of the HHS DAEO regarding my recusal
obligations.
My spouse is an unpaid volunteer for three not-for-profit
organizations. These organizations and her association with
each are as follows:
Christamore House Guild: member (Fall 2001-present); board of
directors (2015-2017).
The Policy Circle: member (Fall 2015-present).
Women for Riley (philanthropic group within Riley Children's
Foundation): member (Fall 2017-present).
I will not participate personally and substantially in any
particular matter involving specific parties in which I know
any of the above three organizations is a party or represents a
party, without first consulting with the HHS DAEO.
3. Describe any activity during the past 10 years in which you have
engaged for the purpose of directly or indirectly influencing the
passage, defeat, or modification of any legislation or affecting the
administration and execution of law or public policy. Activities
performed as an employee of the Federal Government need not be listed.
As a senior executive of Eli Lilly and Company, I had occasions
to meet with members of Congress, administration officials,
Governors, and State officials regarding a variety of issues
including, but not limited to, tax reform, patent reform,
Medicaid, Medicare, coverage status of Lilly drugs, the 3408
program, FDA regulation, and prospective European and Pacific
trade agreements. Some of these activities and contacts, which
were a small portion of my responsibilities, related to
particular legislative or administrative proposals such as the
inclusion of biosimilar legislation in the ACA and for Medicare
coverage of Amyvid, a tool to assist in the diagnosis of
Alzheimer's disease, while others focused more broadly on
topics such as U.S. global tax policy and reform, patent
reform, and drug pricing. While at Lilly, I also on occasion
met with foreign government officials and worked on issues
related to the reimbursement of Lilly medicines in foreign
countries and regarding reforms and designs of foreign health
systems and drug reimbursement systems.
In addition, as a senior executive of Lilly and as a member of
the boards of various trade associations, I have been involved
directly in monitoring (and at times formulating positions
regarding) various health policy proposals, primarily at the
Federal level but also at the State and local level.
As a board member at HMS, I have been involved in discussions
regarding how to get CMS to enhance its efforts to use outside
vendors to pursue waste, fraud, and abuse in the Medicare and
Medicaid programs, how to get the Federal Government to enhance
dependent eligibility verification in the FEHBP, and other
similar areas of business focus for HMS. I also had brief
discussions with individuals in the new administration
regarding ideas HMS had come up with to save taxpayer money
(regardless of the vendor used) through rooting out waste,
fraud, and abuse.
Over the past couple of years, but particularly since leaving
Lilly, I've spoken publicly about the Affordable Care Act, drug
pricing, specialty pharmacy, and FDA regulation. Some of these
speeches and appearances have touched on existing legislative
proposals while others have recommended various government
actions to address drug pricing or other policy issues.
4. Explain how you will resolve any potential conflict of interest,
including any that may be disclosed by your responses to the above
items.
The U.S. Office of Government Ethics (``OGE'') and the HHS
Ethics Office have reviewed my financial holdings, outside
positions, and my existing agreements and arrangements. I have
agreed to take all of the actions that they have requested in
order to resolve any actual or apparent conflict of interest.
The specific actions I agreed to take are detailed in the
ethics agreement I have signed and submitted to the HHS
Designated Agency Ethics Official (``DAEO'').
I will follow the law and the administration's conflict of
interest policies and recuse myself as required. I will consult
with the HHS Ethics Office as needed and will follow the advice
of the HHS DAEO, a career civil service employee, regarding my
recusal obligations.
D. LEGAL AND OTHER MATTERS
1. Have you ever been the subject of a complaint or been
investigated, disciplined, or otherwise cited for a breach of ethics
for unprofessional conduct before any court, administrative agency,
professional association, disciplinary committee, or other professional
group? If so, provide details.
No.
2. Have you ever been investigated, arrested, charged, or held by any
Federal, State, or other law enforcement authority for a violation of
any Federal, State, county, or municipal law, regulation, or ordinance,
other than a minor traffic offense? If so, provide details.
No.
3. Have you ever been involved as a party in interest in any
administrative agency proceeding or civil litigation? If so, provide
details.
In November 2004, an employee of the FDA purported to sue pro
se the Secretary and several other senior and junior officials
of HHS for issues arising out of his employment with the New
York District Office of the FDA. His claim against me was that
my office (the Office of the General Counsel at the time)
allegedly gave advice to agency managers that could ``revoke,
restrict, or chill'' his first amendment rights. The complaint
did not allege that I had any knowledge or personal involvement
in the matters at issue. The Justice Department defended me and
the case was dismissed by the court on September 8, 2005, 2005
WL 2207011 (S.D.N.Y.), No. 04 Civ. 9318 (VM).
On February 13, 2005, my wife and I filed an administrative
appeal of the January 2005 property tax assessment on our then
residence by the State of Maryland. The appeal was with the
Maryland Department of Assessments and Taxation, Montgomery
County, Real Property Appeals, and was identified by Notice
Number 266512, Control Number 7250, Account Number 0700601307.
I do not recall any further proceedings and believe our appeal
was denied.
4. Have you ever been convicted (including pleas of guilty or nolo
contendere) of any criminal violation other than a minor traffic
offense? If so, provide details.
No.
5. Please advise the committee of any additional information,
favorable or unfavorable, which you feel should be considered in
connection with your nomination.
None.
E. TESTIFYING BEFORE CONGRESS
1. If you are confirmed by the Senate, are you willing to appear and
testify before any duly constituted committee of the Congress on such
occasions as you may be reasonably requested to do so?
Yes.
2. If you are confirmed by the Senate, are you willing to provide
such information as is requested by such committees?
Yes.
______
Questions Submitted for the Record to Hon. Alex Michael Azar II
Questions Submitted by Hon. Orrin G. Hatch
medicare hospital insurance (hi) trust fund
Question. The most recent Medicare Trustees report projects that
Medicare's Part A trust fund will be officially bankrupt in 2029, at
which time the Medicare program will no longer be able to pay full
benefits for seniors.
Assuming current law remains unchanged, the Medicare trustees also
estimate that the Medicare Part A total unfunded obligation over 75
years is $3.3 trillion. Using the CMS Actuary's alternative projection,
which looks at Medicare's financial footing using more realistic
assumptions, the Part A unfunded obligation over 75 years climbs to
$9.4 trillion. In your view, what program reforms or changes are
necessary to ensure that Medicare continues to provide appropriate
access to high quality services and remains affordable for both
beneficiaries and taxpayers?
Answer. One of my top four priorities as Secretary, if confirmed,
will be to use the power of Medicare and Medicaid to drive
transformation of our health-care system from a procedure-based system
that pays for sickness to a value-based system that pays for quality
and outcomes. By improving how we operate the program, I believe we can
stretch out the resources to make Medicare more sustainable and allow
it to better serve more beneficiaries as the baby boomer generation
ages into the program. We need to make sure Medicare has long-term
sustainability, and if confirmed, I will work with CMS, Congress, and
other stakeholders to make sure we come up with the right approaches to
work towards this goal.
accountable care organizations (acos) and care coordination
Question. I and Senator Wyden formed a bipartisan, full Finance
Committee chronic care working group, co-chaired by Senators Isakson
and Warner. After over 2 years of collaborative work with Finance
Committee members, MedPAC, CMS, and CBO, we introduced bipartisan
legislation aimed at increasing care coordination in the Medicare
program without adding to the deficit. It goes without saying that this
is a topic that is of great importance to me and to the members of this
committee. That said, I understand that delivering health-care services
to beneficiaries living with multiple chronic conditions is a
challenging task. Private health plans like PPOs and HMOs can create
preferred networks of providers where beneficiaries are charged lower
cost-sharing if they seek medical services in network. ACOs and other
alternative fee-for-service Medicare payment models do not operate the
same way. Given this restriction in Medicare fee-for-service, it
appears our options to strengthen care coordination services are
somewhat limited to, for example, changing the provider payment
structure. Because ACOs are not allowed to navigate their patients to
specific providers, how effective do you believe ACOs will ultimately
be at coordinating care and lowering costs?
Answer. Accountable Care Organizations are a tool in the toolbox to
help ensure high quality, low-cost health care for beneficiaries. Of
course, they are not a silver bullet to all of our country's delivery
system challenges. If confirmed, I plan to work with CMS Administrator
Verma to ensure, as we move forward, that we learn from the results of
ACOs and chart a path forward based on an understanding of what is and
what is not working. I look forward to working with you, if confirmed,
to think about ways the ACO program can be made even more robust as a
vehicle for transformation of our health-care system.
care coordination for the chronically ill
Question. As the population ages, an increasing number of Medicare
beneficiaries have multiple chronic conditions. In your view, is
Medicare well designed to appropriately and efficiently provide care to
these beneficiaries? If not, what more must be done?
Answer. The Medicare program is more than 50 years old, and the
needs of the beneficiaries it serves have evolved since its creation.
As you note, beneficiaries are living longer, and more have multiple
chronic conditions, like diabetes and heart disease. One of my top four
priorities as Secretary, if confirmed, will be to use the power of
Medicare to drive transformation of our health-care system from a
procedure-based system that pays for sickness to a value-based system
that pays for quality and outcomes. If confirmed, I will work closely
with CMS and other Department components to ensure that we are creating
programs that work well for Medicare beneficiaries and deliver higher
quality care at a lower cost.
cms previous goal to tie 50 percent of ffs medicare payments to apms by
2018
Question. In 2015, Secretary Burwell announced the Obama
administration's goal of tying at least 50 percent of traditional, fee-
for-service Medicare payments to the use of alternative payment models
by 2018. While recent ACO demonstrations have shown some promise, these
payment initiatives are still relatively new. Many providers are not
yet ready or willing to take on two-sided risk and write checks to the
government when they exceed their spending targets. Perhaps Secretary
Burwell's intention was to have as many ACOs as possible, with as many
Medicare beneficiaries placed in them as possible, to meet this goal--
even if all the ACOs are not producing evidence that they have and will
continue to improve quality and significantly reduce Medicare spending
over the long-term. If confirmed, how would you quantify success in
this area? Will you act to streamline alternative payment models that
fail and promote the ones that are most successful?
Answer. If confirmed, I look forward to reviewing the actions taken
by health-care providers and CMS to achieve this goal in order to
determine what has worked and what we can improve upon going forward.
ACOs are an important tool, but every approach needs to be evaluated
and refined as we learn more about what delivers higher quality care
and lower costs. I believe firmly in value-based purchasing models and
their potential to incentivize higher quality care and lower costs, and
if confirmed, I will work closely with CMS and other Department
components to ensure that we are creating programs that work well for
Medicare beneficiaries and deliver higher quality care at a lower cost.
medicare delivery system change and ``bending the cost curve''
Question. Many observers believe that the health care delivery
system must change if we are to bend the spending curve over time. What
is Medicare's role in helping to bring about such changes to the entire
health-care system? As Secretary, how would you use Medicare
demonstrations to explore health care delivery system alternatives and
promote the ones that prove successful?
Answer. As I said during my opening statement to the committee, we
must make health care more affordable, more available, and more
tailored to what individuals want and need in their care. I also made
clear that using Medicare as a vehicle for helping to transform our
health-care system to a more value-based system would be one of my four
key priorities as Secretary. If confirmed, I look forward to working
with CMS to explore payment models that reduce costs and increase
quality for Medicare beneficiaries.
CMS recently issued a Request for Information seeking feedback on a
new direction for its Center for Medicare and Medicaid Innovation
(CMMI) to promote
patient-centered care and test market-driven reforms that empower
beneficiaries as consumers, provide price transparency, increase
choices and competition to drive quality, reduce costs, and improve
outcomes. This new direction includes a focus on voluntary models with
defined and reasonable control groups or comparison populations, to the
extent possible, and models that reduce burdensome requirements and
unnecessary regulations to allow physicians and other providers to
focus on providing high-quality health care to their patients. If
confirmed, I look forward to reviewing the comments received and
working on the new direction for CMMI.
impact act implementation
Question. In 2014, I worked closely with Senator Wyden--and leaders
from the House Ways and Means Committee--to enact a bipartisan,
bicameral law called the Improving Medicare Post-Acute Care
Transformation or ``IMPACT'' Act. The IMPACT Act serves as a critical
building block to achieve future Medicare post-acute quality
measurement and payment reform. Specifically, the IMPACT Act requires
the collection of standardized data to help Medicare not only compare
quality across the different post-acute care settings, but also improve
hospital and post-acute discharge planning.
Our goal was to produce data-driven evidence that Congress can use
to debate the best ways to align Medicare post-acute payments that
improve patient outcomes and save taxpayer dollars. Our intention is to
ensure that beneficiaries are receiving the highest quality post-acute
care services in the right setting at the right time. Will you commit
to working with me, members of Congress, and the post-acute provider
community on the implementation of the IMPACT Act?
Answer. Yes. If confirmed, I plan to fully implement all laws
passed by Congress, including the Improving Medicare Post-Acute Care
Transformation Act. I look forward to learning more about this
legislation and working with you, your colleagues and CMS to see that
it is implemented correctly.
opioids
Question. Mr. Azar, we hope a major focus of yours will be on
efforts to combat the opioid epidemic which is ravishing communities
throughout Utah and the Nation. From my perspective, it is obvious that
we must work in a united, coordinated approach to address prevention,
appropriate treatment, research, and reimbursement.
For treatment, we have learned that there are a myriad of large
challenges, including Medicare and Medicaid reimbursement, geographical
disparities in trained providers, and the lurking shadow of stigma. But
I want to highlight an example of a more subtle barrier.
As you may be aware, I was one of the lead sponsors of the DATA
2000 law, along with then Senators Biden and Levin. That law allowed
doctors to prescribe a new medication--buprenorphine--in their offices,
instead of patients having to travel to a methadone clinic. Experts
agree that DATA 2000 really changed the treatment paradigm, making more
therapy options available to patients.
Fast forward to 2018. It is an exciting time in medicine; a number
of new addiction treatment therapies and opioid alternatives are in
development, many with collaboration from the NIH. But for these
therapies to help patients--they must reach patients. The Controlled
Substances Act is silent on whether such provider-
administered therapies may be delivered to the doctor through a
specialty pharmacy--rather than under the ``buy and bill'' system which
requires the practitioner to purchase the product first.
As you are well aware, there are other issues which can challenge
effective treatments, including Medicare and Medicaid coverage. But,
the reason I bring this one issue up is that it is a timely example of
ways we should work to forge a better prevention and treatment system.
So, my question is simple: may we count on you to be sensitive to
removing barriers and forging both an intra-departmental and inter-
departmental collaboration which works to the betterment of patients
and communities?
Answer. Yes. If confirmed, I am committed to working both
internally at HHS and with other Federal agencies to ensure that we are
bringing everything we have to bear to fight this epidemic. The opioid
crisis will remain one of the top priorities at the Department, and I
look forward to looking at governmental barriers that can be removed to
ensure we are best addressing the opioid crisis.
wha
Question. Infectious diseases do not recognize national borders,
thus protecting global health requires inclusions of all relevant
partners. The World Health Assembly (WHA), the decision-making body of
the World Health Organization (WHO), serves as an opportunity to
address health issues around the world requiring international
coordination to effectively combat. Congress has passed legislation
supporting Taiwan's participation in WHA in the capacity of an
observer. With the support of the United States and other like-minded
countries, Taiwan was invited to attend WHA since 2009. However, Taiwan
was excluded from WHA in 2017 for the first time in recent years. As
the head of U.S. delegation to WHA, how do you renew the efforts to
affirm observer status for Taiwan at future WHAs?
Answer. I fully agree with you that global health security requires
all countries to help prevent, detect, control, and fight such
outbreaks of infectious diseases. I agree with you that Taiwan is a
valuable ally in the global health arena and deserves to be treated as
such. If confirmed, I commit to working with the World Health
Organization (WHO) leadership to affirm Taiwan's observer status at
future World Health Assemblies.
barda
Question. In early 2014, the U.S. Department of Health and Human
Services' Biomedical Advanced Research and Development Authority
(BARDA) approached the U.S. manufacturer of INSCOP (Intra-nasal
scopolamine)--a repurposed version of a proven military product--for
civil population protection against a Sarin attack. This U.S.
manufacturer holds the proprietary intra-nasal formulation of INSCOP.
Following a series of meetings and conversations with BARDA, a proof of
concept study was undertaken with a Missouri-based independent not-for-
profit research organization. Data from the evaluation--conducted from
June 2016 to October 2016--showed INSCOP significantly increasing
survival in sarin-exposed animals. Following completion of all
evaluations suggested by BARDA, a one-on-one meeting with BARDA was
held to provide the proof of concept data. BARDA specifically stated
its interest in INSCOP as a chemical defense product and emphasized the
potential use of varying doses of INSCOP in civilian use (pediatric to
geriatric). Concurrently, the U.S. manufacturer of INSCOP was made
aware of a proposal request (RTORCHEM-1003; issued April 13, 2017) from
BARDA for evaluating the efficacy of intranasal scopolamine to increase
survival of guinea pigs exposed to sarin. The U.S. manufacturer was
surprised to learn that BARDA had issued such a RTOR without consulting
with the only company possessing the advanced intra-nasal product. On
September 8, 2017, BARDA awarded a $420,989 contact to a foreign
company from The Netherlands (Nederlandse Organisatie Voor Toegepast-
Natuurwetenschappelijk Onderzoek or TNO) to evaluate the effectiveness
of intranasal scopolamine against sarin in a guinea pig model. The
amount of the award to this foreign entity is significantly higher than
that proposed by the U.S. team, which continues to own the proprietary
formulation of INSCOP. BARDA's charter is to encourage and leverage
industry developments in the service of public health, rather than to
glean concepts and applications from industry and to then develop its
own products. How did BARDA select a foreign entity, and why were U.S.
manufacturers and research organizations, which significantly underbid
the foreign entity for this effort, not selected for this award?
Answer. Not having been at HHS, I am not aware of why BARDA
selected a foreign entity in this instance. If confirmed, I would be
happy to look into the matter and speak with you about this in the
future.
report to congress
Question. The Ensuring Patient Access and Effective Drug
Enforcement Act of 2016 directed HHS to report to Congress regarding
obstacles to legitimate patient access to controlled substances and
issues with diversion of controlled substances, among other things.
That report was due more than a year and a half ago. Will you commit to
making completion of the report a priority for the Department? And, if
confirmed, will you please notify me which agency within HHS is taking
the lead on the report?
Answer. If confirmed, I look forward to getting briefed on the
status of the report and will commit to providing you an update on its
status.
______
Questions Submitted by Hon. Chuck Grassley
glucose monitor coverage
Question. A constituent recently reached out to me about coverage
determinations in regard to glucose monitors.
It was with great excitement that I read about the FDA approval of
a CGM device to be used to make diabetes treatment decisions without
confirmation by a traditional fingerstick in December of 2016.
My constituent raised concerns that his CGM device is not covered.
He states that the device was covered by commercial insurance prior to
his enrolling in Medicare.
My question is, what steps are being taken at FDA (for approval for
use) and CMS (approval for payment) for other technologies in this
space?
Answer. FDA continues to work with product developers to advance
and approve devices that improve the lives of those living with chronic
diseases, including further ``first-in-class'' products. The agency
offers multiple expedited pathways to approval for devices which are
truly cutting edge, and we look forward to seeing other products
receive approval in the coming days and months and years that
contribute to an improved standard of living.
Medicare was first established more than 50 years ago, at a time
when promising advanced technologies that help so many, like continuous
glucose monitors, did not exist. Medicare has evolved since its
creation, and if confirmed, I would be happy to work with Congress to
make sure the program appropriately covers and pays for technologies
that do not fit clearly into one of the existing parts of the program
so that Medicare beneficiaries can benefit from the latest in
prevention, cures, and treatments. In general, the Medicare statute
covers items and services that are reasonable and necessary for the
diagnosis or treatment of an illness or injury. This includes numerous
items and services critical to beneficiaries with diabetes. However,
the items and services are required by Medicare statute to be within
the scope of a Medicare benefit category.
My understanding is that CMS determined that a path to coverage
under the Medicare program is available for additional products used
for the delivery of insulin for the treatment of diabetes. On January
5, 2018, CMS announced that, consistent with the Part D policy to allow
coverage of certain insulin delivery devices, Part D sponsors may
provide coverage of products such as Omnipod under Part D as ``medical
supplies associated with the injection of insulin.''
If confirmed as Secretary, I will work with the CMS team to ensure
that Medicare beneficiaries, particularly those with diabetes, have
access to items and services reasonable and necessary for diagnosis and
treatment as required by the Medicare statute.
orthotics and prosthetics
Question. Medicare currently administratively includes them as part
of DME even though orthotics and prosthetics have very different
purposes and qualities than DME.
Over the past 3 years CMS has released proposed rules concerning
orthotics and prosthetics. The first, on off-the-shelf/minimal self-
adjustment orthotics, and then on qualified providers for orthotics and
prosthetics, which both received thousands of comments. Unfortunately,
rather than promulgating final rules, CMS instead withdrew the proposed
rules in their entirety. There are legislative proposals in both the
Senate and House (S. 1191/H.R. 2599) that underscore and reinforce the
important issues these withdrawn proposed rules cover.
Does HHS have an agenda for the orthotics and prosthetics sector to
ensure fraud and abuse is addressed in a common sense manner, to
protect the safety of patients and quality of care and that recognizes
both the uniqueness of this sector and the needs of the amputees,
disabled, and mobility impaired patients served by this sector?
Will you work to finalize the proposed rules regarding orthotics
and prosthetics?
Answer. If confirmed, I look forward to learning more about this
issue, and working with our CMS teams as well as other stakeholders to
understand the potential benefits and costs. As you mention, there are
various concerns at stake here: Medicare program integrity, ensuring
that we do not jeopardize the needs of those who rely on orthotics and
prosthetics, and reducing burden on suppliers and providers of those
devices. I take these concerns very seriously, and, if confirmed, I
will work with CMS to ensure the Department carefully evaluates this
proposal.
lymphedema
Question. With cancer survivorship on the rise, more and more
Medicare beneficiaries are suffering from a secondary diagnosis called
lymphedema. Senator Cantwell and I have introduced legislation to
provide coverage for compression garments and help beneficiaries manage
this chronic condition. Our Senate bill has 51 cosponsors; the House
companion bill has 304 cosponsors (S. 497/H.R. 930).
We would like to work with you on this initiative, which we believe
CMS has existing authority. In October, Senator Cantwell and I wrote to
Acting Secretary Hargan, bringing this issue to his attention. If
nominated as HHS Secretary would you work with us to help close this
coverage gap?
Answer. Medicare was first established more than 50 years ago, with
a siloed approach to determining what would and would not be covered.
It is important to make sure that we are not being short sighted and
failing to cover a treatment or item that will improve health and save
money simply because it does not fit into a category in Medicare. If
confirmed, I would be happy to work with you and with CMS to explore
whether separate coverage of and payment for compression garments is
possible under the Medicare Part B benefit categories established in
the statute.
national clinical care commission (diabetes)
Question. As you may know, the University of Iowa is home to the
Pappajohn Biomedical Institute, which houses the Fraternal Order of
Eagles Diabetes Research Center. The University is also home to the
Stephen A. Wynn Institute for Vision Research. Among other things,
these premier institutions are conducting cutting edge research on the
neural complications of diabetes in the eye and brain. I could not be
more proud of the innovative work taking place in Iowa to help combat
diabetes, a disease affecting more than 30 million Americans.
Given the increasing prevalence of diabetes and its staggering cost
to the American people, in terms of both dollars and quality of life,
it is necessary to coordinate and leverage Federal programs in order to
improve treatment options for patients. The National Clinical Care
Commission Act passed the Senate by Unanimous Consent. In November
2017, President Trump signed it into law. The commission created by
this legislation will do the important work to find solutions for
diabetes.
As Secretary, you would be responsible for appointing non-
government experts to serve on the commission alongside leaders from a
variety of Federal health agencies. In working on this critical piece
of legislation, Congress felt it important to include on the commission
physician specialists that play a role in the treatment and prevention
of diabetes and its complications, such as severe vision loss,
blindness, and other neural complications. I hope in constituting the
commission, you and your staff will call upon the many talented
individuals performing lifesaving and cutting edge work in this area,
in Iowa and across the country.
Will you work with me and my colleagues to prioritize the
establishment and success of this new commission and to ensure it
includes a diverse group of members with clinical and research
expertise in a variety of medical specialties?
Can you provide a status update on the agency's timeline for
constituting the commission, including when you will call for
applications for appointment to the commission?
Answer. Diabetes prevention and treatment is critically important.
If confirmed, I look forward to working with you and your colleagues on
this issue. I commit to ensuring that the commission is set up and
consists of members that will bring diverse expertise to this work. I
would be happy to provide a status update on constituting the
committee, if confirmed.
______
Question Submitted by Hon. Mike Crapo
Question. In 2016, the American Medical Association (AMA) passed a
resolution recommending that pharmaceutical lawsuit advertisements come
with a warning that patients should consult with a physician before
discontinuing their medications. One AMA Board member noted, ``[t]he
onslaught of attorney ads has the potential to frighten patients and
place fear between them and their doctor. By emphasizing side effects
while ignoring the benefits or the fact that the medication is FDA
approved, these ads jeopardize patient care. For many patients,
stopping a prescribed medication is far more dangerous, and we need to
be looking out for them.'' It has also been noted that ``between $100
and $300 billion of avoidable health care costs have been attributed to
nonadherence in the U.S. annually, representing 3 to 10 percent of
total U.S. health care costs.''
In light of the AMA resolution indicating that lawsuit
advertisements targeting pharmaceuticals are triggering patient
nonadherence to medications and the corresponding evidence that
nonadherence imposes significant costs on the U.S. health-care system,
will you work with the agencies within Health and Human Services,
including the Food and Drug administration and the Centers for Medicare
and Medicaid Services, to ensure patient medication adherence is not
inappropriately impacted by certain advertisements?
Answer. I agree that patient adherence to prescribed medications is
critically important, and we must do all we can to ensure that
individuals are encouraged to follow the directions of their
physicians. If confirmed, I commit to working with the relevant HHS
agencies on this issue.
______
Questions Submitted by Hon. Pat Roberts
Question. CMS recently issued guidelines to expedite the approval
process for 1115 Waivers and State Plan Amendments. What steps do you
think CMS can take to reduce the unnecessary administrative burden on
States that does not provide a benefit to patients? If confirmed, how
would you work with CMS to ensure waivers provide maximum flexibility
to States who are working to both control costs and provide the highest
level of care to patients, but also ensure guardrails to preserve
appropriate services, so no matter where an individual resides they are
assured access to essential services under Medicaid?
Answer. State-driven innovation must be a top priority for the
Department. States, as administrators of the Medicaid program, are in
the best position to assess the unique needs of their respective
Medicaid-eligible populations and to drive reforms that result in
better health outcomes. If confirmed, I will work closely with CMS to
ensure the continued support and the timely review of all State waivers
received by HHS, and to make the waiver approval process more
transparent, efficient, and less burdensome.
Question. The current and previous administrations have provided
flexibility to providers as they have started data collection and
worked toward implementing the Medicare payment reforms under MACRA
(Pub. L. 114-10). However, small, private practice and rural providers
are still concerned about how they will fit into the new system and
MedPAC has shared some concerns and suggestions as well. If confirmed,
will you commit to working with our medical community on solutions to
drive value in Medicare?
Answer. Yes. If confirmed, one of my top four priorities will be to
use the power of Medicare and Medicaid to drive transformation of our
health-care system from a procedure-based system that pays for sickness
to a value-based system that pays for quality and outcomes. In pursuing
that goal, we must pay careful attention to how MACRA and other payment
policies will impact providers of all types, in particular those in
small, private, and rural settings. I look forward to working with you
to emphasize value in Medicare with this in mind.
Question. Last year, CMS requested public comment on a new
direction for the Center for Medicare and Medicaid Innovation (CMMI). I
see this as an opportunity to hopefully put in place some appropriate
guardrails and limitations on the center to ensure beneficiaries are
being protected. If confirmed, how would you direct CMS to utilize
CMMI?
Answer. As I mentioned above, one of my top four priorities as
Secretary, if confirmed, will be to use the power of Medicare and
Medicaid to drive transformation of our health-care system from a
procedure-based system that pays for sickness to a value-based system
that pays for quality and outcomes. CMMI will be a critical part of
these efforts. Of course, we must exercise the power of CMMI and other
authorities in ways that are open and transparent, and that seek out
collaboration and input as much as possible. As you note, CMS recently
issued a Request for Information seeking feedback on a new direction
for CMMI to promote patient-centered care and test market-driven
reforms that empower beneficiaries as consumers, provide price
transparency, increase choices and competition to drive quality, reduce
costs, and improve outcomes. If confirmed, I look forward to working
with CMS to review the input that stakeholders submitted in response to
the RFI, and the opportunity to chart a new direction for CMMI that
puts patients first.
Question. Would striking the non-interference clause under Medicare
Part D save the government, or patients, money? What impact could it
have on access to new innovative therapies?
Answer. My understanding is that the Congressional Budget Office
and others have concluded that removing the non-interference clause
would not generate lower prices than those obtained by prescription
drug plans, and that it would have a negligible effect on Medicare drug
spending. Access to new and innovative therapies could be impaired if
we removed the market-oriented incentives that have made the Part D
program a success for beneficiaries. As I stated at my Senate HELP
hearing a few weeks ago, Part D plans are actually negotiating today
with the three or four biggest pharmacy benefit managers that in turn
negotiate prices with drug manufacturers and actually secure the best
net pricing of any players in the commercial system. If confirmed, I
would like to think about how we can take the lessons from Part D to
improve the rest of Medicare.
Question. CMS recently proposed and then backed away from
significant policy and payment changes to the Medicare home health
benefit. In addition, we have seen regulatory burdens on this sector
increase with face-to-face documentation requirements and the pre-claim
review demonstration. If confirmed, will you work with Congress to
ensure appropriate payments are in place to maintain access and
incentivize quality care for seniors, as well as find ways to reduce
regulatory burdens on providers?
Answer. Yes. One of the goals of this administration that I welcome
and support is ensuring that regulatory burdens that make it costly or
difficult for Americans to access the providers of their choice are
reduced or eliminated. If I am confirmed, I look forward to working
with Congress to promote access to quality health care and remove undue
burdens on health-care providers.
______
Questions Submitted by Hon. John Cornyn
independent payment advisory board (ipab)
Question. The Independent Payment Advisory Board (IPAB), created in
the Affordable Care Act, empowers a small, unelected group to decide on
Medicare spending cuts.
While I have serious concerns about Medicare's current spending
path, I believe that IPAB is the wrong approach to address these
concerns, could override the will of Congress, and could instead
jeopardize access to care for the over 50 million Americans that rely
on Medicare. This is why I have led legislation in the Senate which
would repeal IPAB.
The health reform law also specifically prohibits the IPAB from
making recommendations that would ``ration health care'' or ``otherwise
restrict benefits.'' Would you agree that provider payment rates can be
cut so low that this ultimately leads to rationing of care? As
Secretary, what options would be available to you to prevent this Board
from harming Medicare beneficiaries?
Answer. I share the concerns that you, many of your colleagues, and
doctors and providers have expressed regarding the Independent Payment
Advisory Board (IPAB). Congress should play an important role in any
changes that alter Medicare, and the IPAB would rely on an unelected
group to make decisions about a program that serves millions of
beneficiaries. I agree that providers must be fairly and adequately
reimbursed for the care they are providing, and significant cuts could
make it difficult for Medicare beneficiaries to access care.
I think one of the best ways to drive down costs without harming
beneficiary access to care is to improve how we operate Medicare using
a more value-driven approach. By running the program more efficiently
and effectively, I believe we can stretch out the resources to make
Medicare more sustainable and allow it to better serve more
beneficiaries as the baby boomer generation ages into the program. We
need to make sure Medicare has long-term sustainability, and if
confirmed, I will work with CMS, Congress, and other stakeholders to
make sure we come up with the right approaches to work towards this
goal.
disaster/pandemic preparedness
Question. In the last decade, the CDC has been called upon to
address emerging public health threats such as Ebola, Zika and West
Nile Virus. Many times, Texas has been the frontlines of combating
these diseases, as we've seen in the aftermath of Hurricane Harvey; and
I've seen firsthand the role of local communities, but we also need a
whole government response.
Mr. Azar, under your leadership as Secretary of HHS, could you give
us your thoughts on the role the CDC will play in defending Americans
from disease both at home and abroad? What do you think should be done
moving forward with regard to the U.S. response to these public health
threats?
Answer. If confirmed, I commit to working with the CDC and others
within HHS to ensure that our Nation is prepared to address all
potential public health threats. The CDC is well equipped to work in
concert with State and local governments to provide surveillance and
early detection of possible diseases. Through CDC assets deployed
across the globe, we will ensure that the same level of surveillance
and early detection are utilized to help prevent the spread of foreign
diseases. Moving forward, I believe we need to ensure that our
surveillance systems, and those of our international partners, are
optimized in order to provide timely information that allows us to
identify these public health threats as early as possible, so that we
can proactively address them.
generic drugs
Question. For the past 3 decades, the Hatch-Waxman Act created a
successful marketplace for generic drugs. Today, however, the generics
industry is facing a number of market and public policy challenges that
could undermine competition and decrease access to affordable medicines
for patients.
Recently, both the FDA and the FTC have convened day-long public
meetings/workshops to examine marketplace dynamics that are impacting
generic drug sustainability. If confirmed as Secretary, what steps
would HHS take to ensure that the generic marketplace remains vibrant
and competitive?
Answer. FDA Commissioner Gottlieb is already working on ways to
increase generic competition, by encouraging the development of generic
drugs and speeding approval of such drugs. FDA has unveiled a drug
competition action plan, which will increase competition and help keep
drug prices down. If confirmed, I will work with FDA to help bolster
this effort, and I look forward to working with him to ensure that
increased competition for drugs leads to lower list prices and other
approaches to reducing cost-sharing for patients.
physician-owned hospitals
Question. According to CMS's own quality ratings programs enacted
as part of the ACA, physician-owned hospitals are consistently
outperforming non-physician owned hospitals (POH) in terms of quality
and patient satisfaction. Yet the ACA directly penalizes them by making
it virtually impossible to expand their treatment capabilities if they
want to continue to participate in the Medicare program.
Will you support efforts in Congress to repeal the prohibition on
physician-owned hospitals and amend the expansion criteria in such a
way that it would allow reasonable growth for physician-owned hospitals
that have demonstrated higher quality?
Answer. The Affordable Care Act imposed additional restrictions on
physician ownership and investment in Medicare-participating hospitals,
banning new physician-owned hospitals (POHs) and limiting the expansion
of existing POHs. CMS does, however, have the authority to grant
exceptions to the expansion prohibition for certain applicable
hospitals and high Medicaid facilities. My understanding is that CMS
included a Request for Information on this topic in the 2018 IPPS/LTCH
PPS Proposed Rule in April 2017. This RFI requested information
regarding
physician-owned hospitals, and sought public comment on the appropriate
role of physician-owned hospitals in the delivery system and on how the
current scope of and restrictions on physician-owned hospitals affects
health-care delivery, particularly regarding Medicare beneficiaries. If
confirmed, I look forward to working with CMS to use this feedback to
ensure beneficiary access to high-quality care, and to working with you
on this issue.
home health moratorium
Question. Texas currently has a statewide moratorium on any new
home health agencies. While moratoriums can be a useful tool for fraud
and abuse, this type of far reaching approach could keep bad actors in
the system and stop competition which provides higher quality and more
access. Can you commit to working with Congress to find a more targeted
way of applying CMS moratoria authority?
Answer. Fighting waste, fraud, and abuse is a top priority across
CMS programs and an important part of efforts to increase the
sustainability of the Medicare program. However, we must also examine
efforts made in this area, like the moratorium authority, to make sure
they do not have unintentional consequences such as stifling
innovation, overburdening legitimate providers, or limiting beneficiary
access to high-quality care. As I mentioned during the hearing, if
confirmed, I look forward to hearing ideas from Congress and other
stakeholders to guide our work and make sure our programs are meeting
their goals and appropriately balancing concerns related to program
integrity and patient access.
epipen--patent gaming
Question. During the hearing, you mentioned one of the steps you
would take to lower drug prices would be to take steps to prevent drug
companies from taking advantage of extensions of exclusivity, as well
as fostering competition through the generic market. The EpiPen stands
as an example of a product that has seen massive increases in price,
even with an introduced generic version. What steps would you take to
address the prices of a product like the EpiPen?
Answer. I have made clear my concerns with those companies that
game or ``evergreen'' patents and exclusivities by branded companies
under Hatch-Waxman and other provisions of the Food, Drug, and
Cosmetics Act. If confirmed, I will support the FDA's ongoing efforts
to review its regulatory authorities to identify those abuses which can
be addressed under existing authorities, those which require a
coordinated, cross-government action, and those which require
legislative changes. As we discussed in the hearing, I am particularly
concerned about the issues of (1) branded companies using REMS programs
to prevent the study of the drug and approval of a generic form of the
reference drug subject to REMs, (2) branded companies limiting supplies
of reference product on which to conduct needed studies, and (3)
branded companies securing patented modifications to the underlying
product and withdrawing the previously approved product from the
market, thus making entry of a generic competitor to that earlier
version of the product. In addition, the Food and Drug Administration
Reauthorization Act of 2017 (FDARA), which was signed in to law earlier
this year, clarified that FDA may require a drug be superior to other
drugs on the market in order to receive market exclusivity. I expect
Dr. Gottlieb and FDA will implement these clarifications and look
forward to reviewing whether incentives for innovation are adequately
balanced with timely access to generic competition as intended under
the Hatch-Waxman Act.
ctsa grants
Question. The National Institutes of Health (NIH), specifically,
the National Center for Advancing Translational Sciences (NCATS)/
Clinical and Translational Science Awards (CTSA) programs have been a
major component of the Nation's efforts to support impactful clinical
research. As NCATS maintains the existing support structure, including
maintaining the number of CTSA hub awards, will you support awards to
remain at no less than 64, in addition to continue funding CTSA hub
awards for 5 years?
Answer. I understand that under NCATS's leadership, the CTSA
Program, which represents a national network of medical institutions,
works to improve the translational research process to get more
treatments to more patients more quickly. I recognize that Congress has
significant interests in this Program and its success. If confirmed, I
look forward to working with the NIH Director Dr. Francis Collins and
NCATS Director Dr. Christopher Austin to ensure that the CTSA Program
continues to catalyze innovation in training, research tools, and
processes to meet the needs of the research and patient communities.
cms guidance on medicare conditions of participation
for inpatient hospitals
Question. On September 6th, CMS issued a memo that changed the
Medicare Conditions of Participation for inpatient hospitals. The new
criteria are not unreasonable, but they are effective immediately and
were issued without any input from patients or hospitals. The new rules
risk closing 35 high-quality hospitals in my State that serve a
critical need by providing care to more than 500,000 patients annually
and employing more than 4,000 Texans. Will you work with me to ensure
that the concerns of my Texas hospitals are addressed and provide these
hospitals with at least 12 months to comply with these surprise changes
so that access to care is maintained in my State?
Answer. It is my understanding that CMS is taking steps to evaluate
and streamline regulations and guidance with a goal to reduce
unnecessary burden, increase efficiencies, and improve the beneficiary
experience through their Patients over Paperwork initiative. If
confirmed, I will work with CMS to make sure their programs achieve a
balance between protecting patient safety and avoiding undue burden on
providers as they seek to comply with the Conditions of Participation,
and with you to ensure the concerns of Texas are addressed. If
confirmed, I will certainly review this issue and its impact on Texas
carefully and promptly to make sure your constituents' concerns are
appropriately considered.
car-t therapy
Question. Several companies have recently received approval for a
very promising new type of immunotherapy, known as CAR-T cell therapy,
which relies on modifications to a patient's own immune cells to fight
cancer. This is truly a breakthrough in cancer care, and holds the
promise of saving the lives of patients who would not otherwise survive
their cancer. But these CAR-T therapies are very complex, require
careful monitoring of the patient after administration, and raise
reimbursement challenges for the handful of centers that are qualified
to administer them. Will you commit as Secretary to working with CMS to
make sure that these uncertainties are addressed in short order, so
that we can be sure that eligible patients are able to access these
truly life-saving new therapies?
Answer. Medicare and Medicaid were first established more than 50
years ago, at a time when promising advanced technologies that help so
many, like CAR-T cell therapy, did not exist. Innovations like this
reinforce my belief that current health care payment systems need to be
modernized in order to ensure access to new high-cost therapies,
including therapies that have the potential to cure the sickest
patients. Improving payment arrangements is a critical step towards
fulfilling President Trump's promise to lower the cost of drugs and
therapies. If confirmed as Secretary, I will work with the CMS team to
ensure that Medicare and Medicaid beneficiaries, particularly those
with cancer, have access to technologies that are reasonable and
necessary for diagnosis and treatment as required by statute.
Questions Submitted by Hon. John Thune
Question. Since the inception of electronic health records,
feedback from the hospital and physician community resoundingly
indicate that the burdens of compliance associated with electronic
health records negatively impacts hospitals and doctors. Many of my
colleagues on the committee and I have worked on solutions to mitigate
some of the persistent problems in this space through legislation that
would eliminate the requirement for the Secretary of HHS to make
meaningful use more stringent over time and remove the all or nothing
approach to the program that fails a provider for missing one measure,
among other things. Is this something you would support as Secretary?
What is your vision for ensuring that electronic health records and
other health IT tools are assets rather than burdens for doctors and
patients alike?
Answer. As I said in my opening statement, we can better channel
the power of health information technology and leverage what's best in
our programs and in the private competitive marketplace, to ensure that
the individual patient is at the center of decision-making and his or
her needs are being met with greater transparency and accountability. I
am committed to partnering with health-care providers and stakeholders
to harness the potential of health IT, while reducing burden on
providers and ensuring high-quality care for their patients. If
confirmed, I look forward to working with Congress and stakeholders to
determine what is working and what is not working, as well as what is
duplicative, and what we may be missing to help us move in the right
direction and more fully realize the promise of EHRs without placing
unnecessary requirements on clinicians.
Question. Following last year's budget hearing with then-Secretary
Price, I asked him about how the Department of Veterans Affairs' change
in its electronic health record system would impact the Indian Health
Service, which utilizes the same system. I was assured that IHS had
formed a working group to examine its current platform and that the two
departments would continue their collaborative relationship. If
confirmed, will you commit to continuing that relationship and ensuring
that IHS' EHR system does not fall behind in this transition?
Answer. If confirmed, I look forward to working with the Indian
Health Service to ensure the IHS EHR system meets the needs of
hospitals and health centers serving American Indians and Alaska
Natives.
Question. HHS's Substance Abuse and Mental Health Services
Administration (SAMHSA) has been developing guidelines to recognize
hair testing as a federally accepted testing method since the early
2000s. Transportation industry stakeholders have expressed support for
these guidelines, stating they would provide employers with a longer
detection window than the standard urinalysis, as well as being easier
to collect and harder to adulterate. Regrettably, SAMHSA has delayed
the development of these guidelines. In 2015, Congress endorsed the
accelerated development of the guidelines in section 5402 of the FAST
Act (Pub. L. 114-94), which required the Secretary of HHS to issue
guidelines for hair testing within 1 year of enactment.
As Chairman of the Senate Committee on Commerce, Science, and
Transportation, who oversaw this provision in the FAST Act, I am
particularly interested in getting these guidelines in place. If
confirmed, will you commit to expeditiously completing the required
technical guidelines that could pave the way for more employers to use
this testing method and potentially identify a greater number of
safety-sensitive employees who violate Federal drug testing
regulations?
Answer. If confirmed, I look forward to learning about the work
currently underway at HHS to develop these guidelines and commit to
working with you on this issue.
Question Submitted by Hon. John Thune
and Hon. Rob Portman
Question. The hospital community and health systems in South Dakota
and Ohio have expressed significant concerns regarding CMS's recent
changes to Medicare reimbursement for separately payable drugs in the
340B program. The feedback we've received is that the reduced
reimbursement will impact hospitals' ability to continue serving the
most vulnerable. Will you commit to working with Congress on ensuring
the sustainability of the 340B program in the long-term?
Answer. I understand that CMS recently finalized a change for 2018
to the Medicare payment rate for certain Medicare Part B drugs
purchased by hospitals through the 340B Program in order to lower the
cost of drugs for seniors and ensure that they benefit from the
discounts provided through the program. The reduced payments on 340B
purchased drugs would better align with hospital acquisition costs and
directly lower drug costs for those beneficiaries who receive a covered
outpatient drug from a 340B participating hospital by reducing their
copayments by an estimated $3.2 billion over ten years. Certain
hospitals are exempted from this Medicare payment reduction for 340B
drugs such as rural sole community hospitals, prospective payment
system-exempt cancer hospitals and children's hospitals. Additionally,
all critical access hospitals are not affected by this policy because
they are not paid under the outpatient prospective payment system. If
confirmed, I will faithfully implement any laws related to the 340B
program as passed by Congress and I look forward to working with
Congress and stakeholders to ensure that the 340B program is putting
patients first.
Question Submitted by Hon. Rob Portman
Question. According to the CDC, the number of new HIV infections in
the United States has remained flat around 50,000 cases per year for
the past few decades. What existing authorities do you believe that the
Department of Health and Human Services has to further advance efforts
against these stagnant rates? What further actions do you believe are
necessary to make progress in the fight against HIV?
Answer. If confirmed, I am committed to ensuring HHS remains a
world leader in HIV/AIDS prevention and treatment strategies and
research. I look forward to reviewing both the National HIV/AIDS
Strategy, as well as the National Viral Hepatitis Action Plan, and
working with stakeholders to reduce new infections and improve access
to care and treatment outcomes. I look forward to reviewing the
Department's current work in this area and determining what additional
steps should be taken to address HIV incidence.
______
Question Submitted by Hon. Patrick J. Toomey
Question. One of the great health-care challenges our Nation faces
is the growing prevalence of Alzheimer's disease. Over 5 million
Americans are estimated to be already living with the disease, and if
current trends continue unabated, that number could triple by 2050.
Significantly, Alzheimer's disease is the most deadly disease in our
Nation without an effective means of treatment.
In the private sector, you were part of a team that invested
heavily in trying to meet this unmet need, giving you a rare and
valuable perspective of the current challenges in developing an
effective therapy. As Secretary of Health and Human Services you will
have an opportunity to address this problem in a way afforded to few
others. What will you do to improve our Nation's response to
Alzheimer's disease?
Answer. I share your interest in pursuing effective therapies for
Alzheimer's disease. It affects too many Americans, and its impact will
only continue to grow unless we make advances in treatment and
prevention. We need to review our current research and identify where
gaps exist. We also need to leverage partnerships with the private
sector to bring our collective resources to this great challenge. If
confirmed, I commit to working on this issue and ensuring that the
agency is working collaboratively to address this disease.
______
Questions Submitted by Hon. Dean Heller
addressing nevada's opioid epidemic
Question. Like many States, the opioid epidemic has hit Nevada
hard. According to the Centers for Disease Control and Prevention
(CDC), there were 665 deaths in Nevada due to drug overdose in 2016.
That is why it is critical that Congress has taken steps to help
States address this crisis, and State officials have made combatting
this issue a priority. In fact, last October, Nevada's Attorney General
appointed our first statewide opioid coordinator to assist law
enforcement and victim services coordinate responses to this crisis.
If confirmed as HHS Secretary, how will you assist States like
Nevada confront the opioid crisis?
Answer. The opioid crisis is impacting every State differently, and
we need to support each State in its unique fight against this
epidemic. I know that HHS has distributed more than $800 million in
funding to States through the State Targeted Response to the Opioid
Crisis grants program. We can support the States by providing technical
assistance and help with their surveillance efforts. In addition, the
new Policy Lab that was created by the 21st Century Cures Act will be
critical in identifying evidence-based programs and practices that can
be utilized by the States for prevention, treatment, and recovery. If
confirmed, I commit to working with you to address the specific needs
Nevada is facing with the opioid crisis.
cadillac tax
Question. As you know, Obamacare increased taxes on the American
people by $1.1 trillion dollars. One of the worst taxes was the 40-
percent excise tax on employee health benefits, commonly referred to as
the ``Cadillac tax.''
Across America, nearly 178 million workers who currently enjoy
employer sponsored health care will experience massive changes to their
care by the year 2020.
Hardly anyone in Nevada will be shielded from the devastating
effects of the Cadillac tax. These are public employees in Carson City,
service industry workers on the Strip in Vegas, small business owners
and retirees across the State.
That is why I have worked tirelessly to repeal this bad tax
alongside Senator Heinrich and have worked with my colleagues on a
bipartisan basis to successfully delay its implementation until 2020.
Do you believe that this tax will increase already high out-of-
pocket health-care costs for working families and hit working families
with a new unfair tax?
Can I have your commitment to work with me to provide consumers
relief from the devastating impacts of the Cadillac tax?
Answer. I share your concern regarding the many additional taxes
created by the Affordable Care Act. Ultimately, changes to the Cadillac
Tax or other ACA taxes will need to come from Congress. We need a
health-insurance system that is responsive to the needs of individuals
and their families, and the current system is not working as well as it
could or should. We must address these challenges for those who have
insurance coverage and for those who have been pushed out or left out
of the insurance market by the Affordable Care Act. I look forward to
working with Congress on the best way to achieve the goal of ensuring
that all individuals have access to health care.
______
Questions Submitted by Hon. Ron Wyden
opioid over-prescribing
Question. In your opening testimony, you highlighted the need to
address the opioid epidemic, including the need for ``aggressive
prevention, education, regulatory, and enforcement efforts to stop
over-prescribing and overuse of these legal and illegal drugs.'' In the
hearing, Senator Scott asked for your views on development of
alternative pain treatments and abuse deterrence. ``Abuse-deterrent''
formulations are pharmacologically no different from conventional
opioid medications and have not been proven to be less addictive.
What specific measures will you advocate to reduce inappropriate
prescribing of all forms of opioid medications, be they conventional or
abuse-deterrent formulations? For example, would you support funding
for Pain Management and Substance Use Disorder education initiatives
for primary care providers and subspecialty providers such as
oncologists and cardiologists?
Answer. Overprescribing of opioids is still a major problem, and I
know that HHS is currently ramping up its efforts to address the
problem from both the provider and the patient side. For instance, CDC
has developed guidelines for providers, while at the same time has
launched a media campaign targeting patients. SAMHSA provides
educational tools to help providers identify signs of prescription drug
abuse or doctor shopping. In general, I support these education efforts
and look forward to learning more about the programs underway at HHS.
Payers such as Aetna and retailers such as CVS Health have started to
implement safety edits to incentivize best practices, and that's the
crux of the matter. When appropriate checks are put in the system, at
the provider, payer, and retailer level, we will start to see more and
more progress.
opioid treatment
Question. In your opening testimony concerning the opioid epidemic,
you also stated that ``. . . we need compassionate treatment for those
suffering from addiction.''
What specific measures will you take to ensure that health-care
providers in rural and underserved communities have access to timely
consultation with pain and palliative care experts for patients in the
midst of a national opioid crisis? For example, would you support the
expansion of the use of Telemedicine to increase access of patients to
pain management and addiction specialists?
Answer. As I mentioned during the hearing, addressing the opioid
epidemic will be one of my top four priorities, if confirmed. I share
your concern about the specific needs of the rural and underserved
communities facing this crisis. In general, I am supportive of
telemedicine and believe it can be an effective tool to connect more
rural communities to physicians. If confirmed, I look forward to
working with you on how we can expand this resource to meet the needs
of rural and underserved communities.
nursing home emergency preparedness regulation
Question. Hurricanes Irma and Harvey brought to light the
challenges of protecting frail seniors under disaster conditions from
harm or death. As many as 12 nursing home patients in one Florida
nursing home may have died as a result of inadequate care in the
aftermath of Irma. In September 2016, the Centers for Medicare and
Medicaid Services (CMS) promulgated a rule establishing requirements
for emergency preparedness for Medicare and Medicaid participating
providers and suppliers, including nursing homes (long-term care
facilities). Under the terms of the 2016 regulations, nursing homes
were not required to be in full compliance with those regulations until
November 15, 2017, after Irma and Harvey occurred.
If confirmed, will you commit to implement these new regulations?
What additional measures will you advocate to ensure that there are
adequate protections for seniors in CMS-regulated nursing homes in the
event of natural disasters?
Answer. Patient safety is always a top priority for the Department,
and, if confirmed, I will work closely with CMS and other departmental
agencies to ensure we are taking appropriate actions to protect
patients. As you noted, CMS updated and improved its existing emergency
preparedness requirements for nursing homes and other providers
participating in Medicare and Medicaid by issuing an Emergency
Preparedness Final Rule.\1\ It is my understanding that the new
standards became effective on November 15, 2016 and surveys began
verifying facility compliance with these regulations in November 2017.
If confirmed, I will work with CMS as they monitor the results of these
surveys to make sure facilities are meeting CMS requirements to ensure
preparedness for emergencies and natural disasters.
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\1\ https://www.gpo.gov/fdsys/pkg/FR-2016-09-16/pdf/2016-21404.pdf.
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disclosures to congress
Question. While you were General Counsel at HHS, your office took
the position that legal protections for HHS employees who make
disclosures to Congress--protections which are codified in statute and
in appropriations bills--were not binding on the Department. In
September 2004, GAO concluded that they were in an opinion related to
efforts by HHS to prevent disclosures by the CMS actuary. More
recently, in September 2016, GAO again upheld the application of
appropriations language prohibiting agencies from interfering with
employees making disclosures to Congress albeit with regard to a
different agency--the Department of Housing and Urban Development. The
whistleblower provisions in question have been in appropriations laws
every year since 1978 according to GAO.
Will you commit, as Secretary, to ensure that HHS employees who
make disclosures to the Congress will not be impeded in doing so, nor
retaliated against for making those disclosures?
Answer. Yes. While HHS will determine who speaks for the agency in
matters of interest to the Congress, HHS employees who make disclosures
to the Congress on their own behalf will not be impeded from doing so,
nor retaliated against for making such disclosures.
patient assistance programs
Question. The U.S. Department of Justice recently concluded two
settlements with drug manufacturers which included allegations of anti-
kickback violations related to their participation in third-party
Patient Assistance Programs (PAPs). PAPs generally seek to ameliorate
the effect of high drug prices and co-payments on patients. Co-
payments, in turn, have long been considered a tool for reducing
overall health care costs and there are significant restrictions on
providing co-payment assistance for Federal health programs. (As
discussed in the committee's pre-hearing due diligence questions, one
of these settlements involved a Lilly USA drug--Adcirca--although it
was marketed by a company other than Lilly.) More recently, a lawsuit
was filed against the Department of Health and Human Services and the
Inspector General challenging the Department's ability to regulate
communication and coordination between pharmaceutical companies and PAP
sponsors which could lead to such abuses.
What role did you play in approving Lilly USA's participation in
PAP programs, and what are your views on the role PAPs do and should
play in pharmaceutical manufacturers' pricing policies?
Answer. I believe Lilly USA, LLC's contractual arrangements with
third-party Patient Assistance Programs in the United States were
created, managed, and maintained out of the U.S. Medical Division of
Lilly USA, LLC, which is part of the global medical affairs function at
Eli Lilly and Company. Funding to support grants made by the U.S.
Medical Division to patient assistance programs pursuant to these
arrangements would have come through the budgeting processes of each
respective business unit, so I would have been involved in making funds
available to support grants to patient assistance programs by the U.S.
Medical Division with respect to biomedicines business unit products.
The question regarding pricing policies is not one that I have studied.
responsibilities as president of lilly usa, llc
Question. You were president of Lilly USA, LLC from January 2012 to
January 2017. As discussed at the hearing, during this period you were
chairman of the unit's pricing, reimbursement, and access steering
committee. According to the company's 2016 integrated summary, list and
net prices of Lilly's U.S. product portfolio increased each and every
year during this period.
For some products within the biomedicines division that you headed,
product prices more than doubled during this period.
Please describe your roles and responsibilities while in the
position of president, Lilly USA, LLC., including any executive
committees or responsibilities of Eli Lilly and Company, and your role
in pricing Lilly products in the United States.
Answer. In late 2009, Eli Lilly and Company adopted a global
business unit structure. As part of this change, three global business
units were created with responsibilities for pharmaceutical sales in
the United States: the diabetes, oncology, and biomedicines business
units. Each of these business units is headed by a global president.
These business units own the profit and loss accountability for their
medicines, the budget planning and forecasting for their business, the
hiring, reorganization, termination, sizing, and organization of the
sales forces, brand marketing teams, and payer marketing teams for
their brands, and the sales, marketing, payer, and pricing strategies
for their brands. The biomedicines business unit does this with respect
to all non-diabetes and non-oncology medicines in the United States. In
addition, the biomedicines business unit had the responsibility to
``host'' the two other business units in the United States, Canada,
Japan, Australia, and Europe, providing infrastructure and operations
support to them. Thus, as president of Lilly USA, LLC, I directly led
the biomedicines business unit in the United States with all of the
above-mentioned roles with regard to non-diabetes and non-oncology
products in the United States (which primarily encompassed the areas of
neuroscience, cardiovascular health, men's health, musculoskeletal,
pain, autoimmune disease, and Alzheimer's disease). I reported directly
to the global president of the biomedicines business unit. There was
similarly a vice president of the U.S. diabetes business unit, who
reported directly to the global president of the diabetes business
unit, and a vice president for North America for the oncology business
unit, who reported directly to the global president of the oncology
business unit. Both of these individuals were members of the board of
managers of Lilly USA, LLC. In addition, in my hosting capacity, I
chaired the board of managers of Lilly USA, LLC, the legal entity for
the sales and marketing organization in the United States, and
supervised the sales, marketing, and payer operations, which provided
support to all three business units. Payer operations, led by the
Managed Healthcare Services organization, represents Lilly's U.S.
business units in negotiating to secure appropriate patient access to
Lilly products and resources through population-based decision makers
at private and public insurers, pharmacy benefit managers, hospital
systems, wholesale distributors, retail pharmacies, specialty
pharmacies, oncology practices and purchasing organizations, group
purchasing organizations, and senior care facilities and purchasing
organizations, as well as the management of those arrangements. Sales
and marketing operations included services such as managing the fleet
of cars for sales representatives, managing the production,
warehousing, and distribution of marketing and sales materials, sample
integrity and accountability systems, supervision of the customer
information quality system for approval of marketing materials, and
administration of the sales incentive systems per parameters and goals
set by the respective business units for their teams. I also served as
chair of the Lilly USA, LLC, pricing, reimbursement, and access
steering committee, as a member of the Eli Lily and Company Corporate
Compliance Committee, and at some point was a member of a corporate
manufacturing quality and patient safety committee. I do not recall if
I was a member of any other executive committee in this role.
With respect to pricing, as described above, in late 2009, Eli
Lilly and Company adopted a global business unit structure. For the
first couple of years of my tenure as President of Lilly USA, LLC, in
my capacity as chair of the Lilly USA, LLC, pricing, reimbursement, and
access steering committee, that role approved pricing recommendations
from the diabetes and oncology business units (although launch pricing
was approved at the relevant global business unit level), as well as
recommendations regarding biomedicines business unit prices.
Recommendations from the profit and loss accountable diabetes and
oncology business unit leaders were expected to receive and did receive
deference since they owned the budget planning and forecasting for
their business, the payer marketing teams for their brands, and the
payer and pricing strategies for their brands. In 2014, Lilly's
governance processes were regularized to recognize the business unit
structure, and the vice presidents of the diabetes and oncology
business units were formally given the approval authority for pricing
of their medicines in the United States.
marketing programs at eli lilly
Question. Allegations have been made in a qui tam lawsuit that Eli
Lilly improperly provided services of financial value to U.S.
prescribers of Lilly drugs, such as nurse educator and reimbursement
support services, to serve as inducements to prescribe Lilly drugs.
These are alleged to have occurred, in part, through Lilly-
sponsored nurse educator programs such as the Diabetes Interactive
Network and Forteo Connect. Forteo was a Lilly drug marketed by the
biomedicines business unit, which you headed. Lilly is alleged to have
made arrangements through four companies to provide these services:
HealthSTAR Communications of Mahwah, NJ; VMS BioMarketing of
Indianapolis, IN; Covance of Princeton, NJ (a subsidiary of Laboratory
Corporation of America); and UBC (a subsidiary of Express Scripts of
St. Louis, MO.)
In your capacity as a senior executive at Lilly USA, did you ever
negotiate, oversee, manage, or approve contracts or business
relationships with any of these firms to assist in the marketing of
Lilly drugs in the United States? If so, please describe those actions
and when they occurred.
Answer. By way of background, each of these referenced programs
related to Forteo (injection training, Forteo Connect, and patient
reimbursement support) existed to assist patients who had already been
prescribed Forteo in having a safe and positive patient experience with
Forteo. Any promotional activity by individuals involved in these
programs to encourage prescribing of Forteo would have been contrary to
Lilly policies. These programs were to educate and train largely
elderly patients to use a daily, self-injectable, cold-chain storage
specialty medicine, to help them navigate a difficult reimbursement
environment with payers, and to assist them in adhering to their
medicines once started. These programs would have been vetted and
reviewed by counsel periodically to ensure compliance with all relevant
laws, regulations, and industry practices.
While these programs operated within the biomedicines business
unit, I believe any business contractual relationships with the above-
referenced firms would normally have been negotiated and contracted by
Lilly's global procurement organization on behalf of those who were
responsible for managing these programs within the biomedicines
business unit in the United States.
With regard to the specific above-referenced entities, I do not
recall knowing of HealthSTAR Communications. I know of VMS
BioMarketing, but in the context of providing meeting planning services
to Lilly. I do not currently recall VMS being involved in the Forteo
injection training program. UBC provided patient support HUB services
(services offered to patients, at their request, through the Internet
and/or telephone in connection with an already-prescribed specialty
medicine) at various times for Forteo, and perhaps other products that
I do not now recall. I believe in 2015 the Forteo patient support HUB
services were moved from UBC to Covance. My memory is that at some
subsequent point other brand patient support HUB services were
consolidated to Covance. Patient support HUB services are administered
as non-promotional programs within the Managed Healthcare Services
function of Lilly USA, LLC, for all business units. As noted above, I
believe any such business relationships are negotiated and contracted
by Lilly's global procurement organization on behalf of the Managed
Healthcare Services team that manages these programs.
Question. In your capacities as a senior executive at Lilly USA,
did you ever oversee, manage, or approve nurse educator programs, such
as Forteo Connect, or reimbursement services for providers?
Answer. The Forteo injection training program was offered during my
tenure as president of Lilly USA, LLC, and I believe before my tenure.
As indicated above, in my role as president, I led the biomedicines
business unit, which included Forteo. I believe this program was
administered within what was originally called the Musculoskeletal
Health Business Unit within the biomedicines business unit and later
called the Specialty Business Unit within the biomedicines business
unit. I do not recall whether a similar injection training program was
offered for any other biomedicines business unit products during my
tenure. I would have to refer you to Lilly regarding details of any
nurse educator programs in the diabetes or oncology business units.
HUB services for Forteo and any other brands of any business unit
are managed within the Managed Healthcare Services organization, which
I directly led from April 2009 through December 2011, and which
reported to me as president of Lilly USA, LLC, from January 2012
through January 2017.
The patient reimbursement support services non-promotional field-
based team was managed for all business units within the Managed
Healthcare Services organization, which reported to me as president of
Lilly USA, LLC, from January 2012 through January 2017 (this function
did not exist when I was the vice president of Managed Healthcare
Services). This function was to assist patients prescribed specialty
medicines, at their request, in navigating through the benefit
investigation process, ensuring their physicians have any needed prior
authorization forms, and, depending on the brand, providing support to
patients should they need to appeal the denial of coverage by their
payer/specialty pharmacy, and generally attempting to assist patients
in securing appropriate coverage of a medicine they have already been
prescribed. These are all support programs intended for the benefit of
patients already prescribed a medicine. These programs operate
similarly to the patient support HUB services programs described above,
except that these individuals work in-person, rather than over the
Internet or telephone. Any promotional activity by individuals involved
in these programs to encourage the prescribing of a medicine would have
been contrary to Lilly policies. These programs would have been vetted
and reviewed by counsel periodically to ensure compliance with all
relevant laws, regulations, and industry practices.
world health assembly
Question. With the support of the U.S. Congress and international
partners, Taiwan was invited to participate as an observer in the World
Health Assembly (WHA)--the World Health Organization's (WHO) decision-
making body--between 2009 and 2016. My position has long been that the
fight against infectious disease is a global one and will require the
participation of global partners, regardless of political
considerations. Like many Senators, I was disappointed to see Taiwan
excluded from the WHA in 2017, and I believe continued exclusions will
only make it more difficult to provide solutions to global health
challenges. If confirmed, how would you renew the Department's efforts
to secure observer status for Taiwan at future WHA meetings?
Answer. I fully agree with you that global health security requires
all countries to help prevent, detect, control, and fight such
outbreaks of infectious diseases. I agree with you that Taiwan is a
valuable ally in the global health arena and deserves to be treated as
such. If confirmed, I commit to working with the World Health
Organization (WHO) leadership to affirm Taiwan's observer status at
future World Health Assemblies.
human services
Question. The President's budget proposed eliminating funding for
the Social Services Block Grant (SSBG), a flexible funding stream for
social services programs such as substance use disorder treatment
services, child protection, elder protection, services for the elderly
like Meals on Wheels, and other critical safety net programs. It also
helps fill in financial gaps for overburdened State foster care systems
which are facing an increased strain in light of the opioid epidemic.
In light of increased demands on State human services programs
brought on by the opioid epidemic, do you support this elimination?
If so, where do you suggest States turn to make up for the loss of
these flexible SSBG dollars if funding is eliminated? Please be
specific in terms of which programs you believe would fill the void
left by SSBG.
Answer. The opioid crisis is one of the top priorities I will be
working on if confirmed as Secretary. If confirmed, I plan to ensure
that all components of the Department are dedicated to advancing the
five-point strategy developed to address this issue. If confirmed, I
will work with the Administration for Community Living to advocate for
and enhance OAA programs within the budget constraints of the current
fiscal environment. Also, I believe the use of innovation and evidence-
based practices will be critical to meeting the needs of our growing
population of older Americans and of those with disabilities.
Question. The Temporary Assistance for Needy Families (TANF)
program has not had a substantive reauthorization since 2005. If
confirmed, what would be your policy priorities for a TANF
reauthorization?
Answer. If confirmed, I look forward to working with the leaders of
the Administration for Children and Families to build upon what they
have learned and to ensure the Temporary Assistance for Needy Families
(TANF) program is as successful as possible. Responsible reforms should
focus on reducing burdens and inefficiencies and should recognize that
States, which have been the laboratories for innovation in social
welfare programs, are in a better position than the Federal Government
to operate programs that best meet the needs of their citizens. I see
the Federal Government's role as a catalyst for engaging all sectors of
the community to develop and implement a shared vision to grow the
capacity and reduce the dependency of economically and socially
vulnerable populations.
Question. Do you believe the 1996 welfare law was a success and
upon what outcomes--particularly those specifically attributable to the
law and not external factors--do you base that determination?
Answer. After enactment of the 1996 welfare reform law, the
employment rate of single mothers rose from an average of 58.6 percent
in the 5 preceding years (1991-1995) to an average of 70.2 percent in
the 5 years after reform (1997-2001).\2\ As a result, the official
poverty rate among single mother-led families fell from 44.0 percent in
1994 to 33.0 percent in 2000 and was still well below pre-welfare
reform levels in 2016 (35.6 percent).\3\ More than 20 years later, I
see opportunities to revitalize the law's goals and to improve the
efficiency and effectiveness of our welfare programs to the benefit of
recipients and taxpayers. If confirmed, I will work across the
Department to prioritize reforms that maintain an emphasis on national
values of work, community engagement, and personal responsibility.
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\2\ ASPE tabulations from the Current Population Survey, Annual
Social and Economic Supplement.
\3\ U.S. Census Bureau, Historical Poverty Tables, Table 4, https:/
/www.census.gov/data/tables/time-series/demo/income-poverty/historical-
poverty-people.html.
Question. The President has repeatedly stressed his desire to
promote employment. And the administration recently signaled that the
Department will approve unprecedented section 1115 Medicaid
demonstration waivers that would allow States to condition receipt of
Medicaid for otherwise eligible individuals on meeting certain work
requirements. As you know, TANF is the primary program under HHS's
jurisdiction aimed at helping poor parents find employment and escape
poverty. States are expected to use these flexible funds to help
connect disadvantaged populations to employment. Yet at a time when the
administration is telling States they can require recipient of
essential health care under Medicaid to meet burdensome work
---------------------------------------------------------------------------
requirements, the President's budget has proposed deep cuts to TANF.
Do you support these proposed TANF cuts?
What do you view as the policy rationale for these proposed cuts?
Answer. If confirmed, I look forward to working with the leaders of
the Administration for Children and Families to build upon what they
have learned and to ensure the Temporary Assistance for Needy Families
(TANF) program is as successful as possible and that funds are used in
the most efficient and effective manner.
Question. The Maternal, Infant, and Early Childhood Visitation
program (MIECHV) is a program that members on both sides of the aisle
have championed due to the demonstrated success of its models in
improving the health and well-being of mothers and children. MIECHV's
innovative model has well-established goals, outcomes and metrics.
At current funding levels ($400M/year), the Department of Health
and Human Services estimates that only 3 percent of the eligible
population receives MIECHV services. I believe Congress and the
administration should work to expand this important program. Instead,
the program's authorization expired at the end of the fiscal year.
If confirmed, will you work with me and members on both sides of
the aisle to ensure the continuation and expansion of MIECHV?
Answer. If confirmed, I look forward to working with members of
Congress from both sides of the aisle on the reauthorization of the
Maternal, Infant, and Early Childhood Home Visiting Program.
Question. The United States is the only industrialized country
without paid maternity leave.\4\ The President has endorsed such leave
for new mothers.
---------------------------------------------------------------------------
\4\ http://www.oecd.org/els/family/
PF2_5_Trends_in_leave_entitlements_around_childbirth.
pdf.
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Do you support a governmental paid parental leave program?
If confirmed, how might you lead the Department to help support the
goal of expanding access to paid parental leave? Please be specific
about resources and expertise that may be available at HHS, including
in such areas as benefit design, eligibility determination, IT systems,
and program access.
Answer. If confirmed as Secretary, I will support the work of the
administration to enact family-friendly policies, and will strive for
HHS to be a place that is supportive of working parents.
Question. A recent article in Health Affairs looked at the
connection between opioid prescriptions and foster care entries. While
the article is specific to Florida, national data and data in many
States indicate that as the opioid epidemic has expanded, the foster
care system is coming under increased strain. According to the article:
Based on the full sample estimates, a one-standard-deviation
increase in the statewide opioid prescription rate was
associated with over 2,000 additional Florida children being
removed due to parental neglect. The resulting fiscal cost was
roughly $40 million, which did not include the psychological
and physical effects and health care costs for affected
children. For instance, neonatal abstinence syndrome primarily
affects infants exposed to opioids. The syndrome's incidence
rate in Florida per 1,000 hospital births increased from 0.4 in
1999 to 6.3 in 2013; 39 nationwide, the syndrome was
responsible for approximately $1.5 billion in hospital charges
in 2012. Many of these children will require ongoing
psychiatric and physical care, which compounds our cost
estimates.\5\
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\5\ Quast et. al., ``Opioid Prescription Rates and Child Removals:
Evidence From Florida,'' Health Affairs 37, No. 1 (2018): 134-139.
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Are you aware of these trends in foster care?
If confirmed, would you support efforts to increase services and
supports to children and families, including grandparents and other
potential relative caregivers, to help safely prevent foster care
entries?
Answer. With the opioid crisis, supporting grandparents and
relatives who act as primary caretakers in their families is an
emergent need and one that the Substance Abuse and Mental Health
Services Administration (SAMHSA) is committed to addressing in its
programs and policy initiatives. If confirmed, I will encourage SAMHSA
to collaborate with the Administration for Community Living to ensure
complementary efforts. However, older adults raising children and youth
have concerns that affect all areas of their family lives: education,
transportation, primary health care, behavioral health care, financial
stability, and for some, juvenile justice. Working together with our
Federal partners, including the Department of Education, the Department
of Justice, and the Department of Housing and Urban Development, we can
help ensure that any programs and policy initiatives address the full
range of needs grandparents and other caregiving relatives may have.
Close coordination will ensure all efforts leverage the full range of
resources across the Federal government in ways that are non-
duplicative and financially efficient.
Question. I am concerned about the potential discriminatory impacts
of recent efforts undertaken at HHS to promote ``religious liberty.''
For example, HHS's new draft strategic plan and the recent HHS Request
for Comment on ``Removing Barriers for Religious and Faith-Based
Organizations to Participate in HHS Programs and Receive Public
Funding'' may serve as a signal to Federal contractors that they have a
license to discriminate against the children and families they serve,
using the justification of religious beliefs. I am not alone in holding
these concerns. Numerous child welfare organizations and children's
advocates indicated in their comments to HHS in November very serious
concerns about how children will be harmed if HHS allows adoption and
foster care providers to discriminate under the guise of liberty.
For example, the American Academy of Pediatrics stated: ``We urge
HHS to not make policy changes that would enable possible
discrimination against children in the child welfare system or
prospective foster or permanent families. Regardless of whether a
specific HHS grant or contract is supporting child welfare services,
HHS should not provide grants and contracts to entities involved in
child welfare services that engage in discrimination against children
or families based on sexual orientation, gender identity, marital
status, or faith.'' \6\ The Children's Defense Fund said: ``Allowing an
organization to deny the application and licensure of certain
individuals--like those who identify as LGBT, individuals not married,
or people of certain religious faiths--would create additional strain
on an already overtaxed system looking for foster and adoptive families
with the best interest of the child the uppermost concern.'' \7\
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\6\ https://www.regulations.gov/document?D=HHS-OS-2017-0002-12098.
\7\ https://www.regulations.gov/document?D=HHS-OS-2017-0002-11661.
I share these concerns that federally funded foster care and
adoption agencies will interpret ``religious liberty'' as permission to
restrict the types of families they place children into based on
religion, marital status, sexual orientation, or other factors
unrelated to the best interests of the child, and thus drastically
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limit the number of homes open to children who need them.
If confirmed as Secretary of HHS, what will you do to ensure that
children are not denied access to qualified homes based on irrelevant
factors that do not put the interests of the child first, but rather
the personal beliefs of the contractor?
Answer. If confirmed, I will work with the leadership of the
Administration for Children and Families to ensure the foster care and
adoption programs continue to have at the forefront the best interests
of the children needing these important services.
Question. A 2014 study of the foster care system in Los Angeles
found that 19 percent of foster youth over the age of 12 identify as
lesbian, gay, bisexual, or transgender.\8\ If child welfare agencies do
not provide culturally competent care, children suffer harm. The
American Academy of Pediatrics has said in comments to HHS, ``Policies
that single-out or discriminate against LGBTQ youth are harmful to
social-emotional health and may have lifelong consequences.'' And the
Center for Study of Social Policies reported in comments to HHS that
``[c]hildren and youth who identify as lesbian, gay, bisexual,
transgender, queer (LBGTQ) are disproportionately involved with child
welfare and experience worse outcomes than their peers due to trauma
they often experience while in State care'' \9\ (emphasis added).
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\8\ https://www.acf.hhs.gov/sites/default/files/cb/
pii_rise_lafys_report.pdf.
\9\ https://www.familyequality.org/equal_family_blog/2018/01/04/
2302/child_welfare_
agencies_to_hhs_no_licensetodiscriminate_it_hurts_children.
HHS's 2014-2018 strategic plan included the following goal:
``Support the safety, well-being, and healthy development of children
and youth, including children and youth who have been maltreated, who
have disabilities, who are integrating into U.S. society, and who are
experiencing homelessness, including lesbian, gay, bisexual, and
transgender (LGBT) youth and other vulnerable populations.'' That goal
was removed from HHS's draft 2018-2022 strategic plan, as were all
mentions of health and human services disparities experienced by LGBT
people and almost all mentions of health and human services disparities
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experienced by other minorities. That removal is of grave concern.
Will you commit that HHS will promote the health and well-being of
all youth, including LGBT youth, and will work to ensure that LGBTQ
youth receive culturally competent care, whether they are foster youth,
are unaccompanied refugee minors, or are other youth served by HHS
programs?
Will you commit that HHS will ensure that LGBTQ youth in their care
are placed in affirming and accepting homes and families?
Will you commit that LGBTQ minors will not be placed in homes or
settings where they will be subjected to harmful conversion therapy, a
medically discredited practice to change the sexual orientation or
gender identity of an LGBTQ person--which has been outlawed for minors
in nine States, including Oregon?
Answer. If confirmed, I will work with the leadership of the
Administration for Children and Families to ensure the foster care and
adoption programs continue to have at the forefront the best interests
of the children needing these important services. My mission, if
confirmed, will be to enhance and protect the health of all Americans,
and this would most certainly include the children supported through
HHS programs. Part of that mission is to ensure that everyone is
treated with respect, especially in the provision of human and health
services.
Question. Research has shown that both in TANF and outside it,
individuals who receive targeted career and technical education,
including having the opportunity to acquire credentials, participate in
``career pathways'' programs, and serve apprenticeships, are the most
likely to get and keep good jobs. Under current TANF work participation
calculations, States that use these evidence-based strategies widely
are disadvantaged. For this reason, Governor Kasich of Ohio applied to
HHS for a waiver of TANF's restrictions on career and technical
education several years ago.
Do you support allowing States to improve access to career and
technical education without penalty, so that low-income parents can get
and keep good jobs?
If so, what legislative proposals would you make to address this
ongoing problem with TANF?
Answer. If confirmed, I look forward to working with the leaders of
the Administration for Children and Families to build upon what they
have learned and to ensure the Temporary Assistance for Needy Families
(TANF) program is as successful as possible. Responsible reforms should
focus on reducing burdens and inefficiencies and should recognize that
States, which have been the laboratories for innovation in social
welfare programs, are in a better position than the Federal Government
to operate programs that best meet the needs of their citizens. I see
the Federal Government's role as a catalyst for engaging all sectors of
the community to develop and implement a shared vision to grow the
capacity and reduce the dependency of economically and socially
vulnerable populations.
health care
Measuring Success at Lowering Prescription Drug Prices
Question. President Trump has repeatedly promised the American
people he will lower prescription drug prices. During his first year in
office, there has been no progress. Mr. Azar, during your confirmation
hearing you acknowledged that ``drug prices are too high'' and
committed to fulfilling the President's promise to lower drug prices. I
am hopeful you can change the direction of the administration and make
real progress.
In order to know if that is occurring, what metrics would measure
success in this area?
In January 2019--a year from now--what should we look at to measure
whether or not you and the administration have been successful at
making prescription drugs more affordable for the American people?
Answer. As I said during my opening statement to the committee,
drug prices are too high. The President has made this clear. I would
like to work to ensure that there is adequate competition, which would
lead to lower pricing. Additionally, Commissioner Gottlieb is already
working on ways to increase generic competition, by encouraging the
development of generic drugs and speeding approval of such drugs. FDA
has unveiled a drug competition action plan, which will increase
competition and help keep drug prices down. If confirmed, I will work
with FDA to help bolster this effort, and I look forward to working
with him to ensure that increased competition for drugs leads to lower
list prices. This is a metric that would indicate success in addressing
drug pricing.
Pharmaceutical Supply Chain
Question. U.S. spending on prescription drugs is growing rapidly,
and evidence suggests that rising drug costs can be attributed to a
broken pricing system involving multiple actors. As a former
pharmaceutical executive, you have insight into this broken system.
If confirmed, what specific reforms would you pursue for each actor
in the supply chain to lower the cost of drugs?
What would you do to bring down prices set by drug manufacturers?
What specific reforms would you pursue regarding Pharmacy Benefit
Managers and Wholesalers?
What would you do to reform health plans?
Answer. As I said at my confirmation hearing, drug prices are too
high. The existing system for pricing and reimbursement of drugs works
for many of the players in the system, but not for patients who have to
pay high out-of-pocket costs for their drugs because of lack of
insurance, high deductibles, or high cost sharing. Drug pricing is
informed by a multitude of factors including the list price,
competitive market dynamics, government rebate programs, insurer market
power, discounts to the list price, and research and development costs,
to name a few. If confirmed, I will work to make sure that patients
benefit from lower drug costs.
PBMs
Question. During the hearing, you testified about the significant
negotiation power that pharmacy benefit managers (PBMs) have in
Medicare Part D to secure ``the best rates of any commercial payers''
for the Medicare program.
You also proposed applying principles from Medicare Part D to how
the Medicare program pays for Part B drugs, which you suggest could
lower costs for both beneficiaries and the Medicare program.
In your view, what specific principles from Medicare Part D should
be applied to how Medicare pays for Part B drugs?
Please describe in detail how those Part D principles would be
applied to Part B under your proposal.
During the HELP hearing, you stated that ``everyone shares blame''
in the drug pricing system, making PBMs partially responsible for the
high and rising costs of prescription drugs. To the extent that your
proposal includes utilizing PBMs (or entities similar to PBMs) in
Medicare Part B, please explain why you believe that PBMs would have
the opposite effect--lowering drug prices--in Part B.
Answer. Through my experience helping to implement Part D and with
my extensive knowledge of how insurance, manufacturers, pharmacy, and
government programs work together, I believe I bring skills and
experiences to the table that can help us address these issues, while
still encouraging discovery so Americans have access to high-quality
care.
The President has generally spoken about the desire to ensure that
Medicare is negotiating and getting the best deal possible for drugs.
As I stated at the hearing, Part D plans are actually negotiating today
with the three or four biggest pharmacy benefit managers that negotiate
and actually secure the best net pricing of any players in the
commercial system. If confirmed, I would like to consider more ways to
take the lessons from Part D to improve Medicare.
Question. You expressed support for using national emergency powers
to provide the HHS Secretary with the authority to negotiate reduced
pricing for Naloxone to address the opioid epidemic.
Why is direct government negotiation preferable to PBM negotiation
under this circumstance?
What other circumstances or drugs present such a dire circumstance
similar to the opioid crisis that direct negotiation by the government
would result in lower prices?
Answer. As we fight this opioid epidemic, I believe access to
naloxone is critical. I support efforts to assist in these purchases
and, if confirmed, will review the current efforts underway in this
area. I am not aware of any authorities provided by the Public Health
Service Act under a public health emergency, or by the National
Emergencies Act under a national emergency, that would permit me, if
confirmed, to negotiate reduced drug pricing for naloxone. If
confirmed, I commit to looking into whether HHS has programs and
funding whereby HHS could negotiate for and procure naloxone for use by
public health emergency first responders. In addition, in an effort to
expand access, I would like to work to ensure that there is adequate
competition for naloxone, which would lead to lower pricing. FDA has
indicated the agency is identifying ways to encourage OTC naloxone
applications. Additionally, Commissioner Gottlieb is already working on
ways to increase generic competition, by encouraging the development of
generic drugs and speeding approval of such drugs. FDA has unveiled a
drug competition action plan, which will increase competition and help
keep drug prices down. If confirmed, I will work with Dr. Gottlieb and
FDA to help bolster this effort.
MACRA Implementation
Question. Ensuring the successful implementation of the Medicare
physician payment reforms included in the bipartisan Medicare Access
and CHIP Reauthorization Act of 2015 (MACRA) will be one of the most
important issues faced by the new HHS Secretary.
In your view, what are the most significant challenges regarding
successful implementation of the Merit-based Incentive Payment System
(MIPS)--and how would you approach those challenges as HHS Secretary?
What about with respect to the Advanced APM track?
In your opinion, what have HHS and CMS done well in terms of MACRA
implementation, and where do you see opportunities for improvement?
Answer. I agree with the goals of MACRA, and I commend Congress for
taking action toward stabilizing Medicare Part B payments for
clinicians. MACRA repealed the flawed Sustainable Growth Rate formula,
which put clinicians in Medicare at the risk of recurring payment cuts,
and replaced it with a new program that CMS calls the Quality Payment
Program. However, like any new program requiring significant changes to
the way clinicians are paid within Medicare, the Quality Payment
Program has faced barriers to achieving the well-intended goals it was
designed to accomplish. Most clinicians who receive Medicare Part B
payments must participate in one of two tracks, and clinicians face
unique challenges under each track. The Merit-based Incentive Payment
System (MIPS), which adjusts clinician payment based on performance,
requires reporting of different types of measures across numerous
performance categories, and it has been challenging for clinicians to
learn and understand these new program requirements. A key challenge
under MIPS going forward will be to measure the quality of care in a
meaningful way that does not require an unduly burdensome amount of
time and resources.
Alternatively, clinicians may participate in one of several
Advanced APMs, which allows clinicians with sufficient participation to
earn a 5 percent incentive payment by going further in improving
patient care and taking on risk. However, there are concerns there are
too few Advanced APMs, and the process to develop new models is
extensive and lengthy. It is my understanding that CMS released a
Request for Information \10\ seeking public feedback on a new direction
for the Innovation Center and ways to promote patient-centered care and
test market-driven reforms that empower beneficiaries as consumers,
provide price transparency, increase choices and competition to drive
quality, reduce costs, and improve outcomes. If confirmed, I look
forward to reviewing the comments received on the Request for
Information as well as the Physician-Focused Payment Model Technical
Advisory Committee's comments and recommendations on these proposals to
help ensure CMS increases the number of available Advanced APMs.
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\10\ https://innovation.cms.gov/Files/x/newdirection-rfi.pdf.
It is my understanding that CMS is working closely with
stakeholders to maximize clinician flexibility and to make the
transition as smooth as possible, however much additional work lies
ahead if this program is to achieve the goals of improved quality and
improved value-based payment intended by the MACRA statute.
CMMI RFI
Question. In September 2017, under the Trump administration, the
Center for Medicare and Medicaid Innovation (CMMI) issued a Request for
Information (RFI) regarding a ``new direction'' for CMMI. The RFI
hinted at specific policies under consideration that would increase
out-of-pocket costs for Medicare beneficiaries--including allowing
physicians to balance bill Medicare beneficiaries and turning Medicare
into a voucher program (i.e., premium support).
If confirmed as HHS Secretary, will you commit to not pursuing any
CMMI models that would allow doctors to balance bill Medicare
beneficiaries?
Will you commit to not pursuing any CMMI models testing the use of
vouchers in Medicare (i.e., premium support)?
Will you commit to making all of the responses to the CMMI RFI
publicly available?
Answer. One of my top four priorities as Secretary, if confirmed,
will be to use the power of Medicare and Medicaid to drive
transformation of our health-care system from a procedure-based system
that pays for sickness to a value-based system that pays for quality
and outcomes. CMMI will be a critical part of these efforts. Of course,
we must exercise the power of CMMI and other authorities in ways that
are open and transparent, and that seek out collaboration and input as
much as possible. I am not familiar with any details or deliberative
process behind the most recent actions cited in this question, but if
confirmed, I look forward to exploring models that reduce costs and
increase quality for Medicare beneficiaries, taking full advantage of
the stakeholder input CMS receives through the recent RFI.
ASPE RFI
Question. On December 26, 2017, the Department of Health and Human
Services (HHS) released the ``Promoting Healthcare Choice and
Competition Across the United States'' Request for Information (RFI) on
the Office of the Assistant Secretary for Planning and Evaluation
(ASPE) website. The RFI solicits stakeholder comments on State and
Federal laws, regulations, guidance, requirements, and policies that
discourage or prevent the development and operation of a health-care
system that provides high-quality care at affordable prices for the
American people, the promotion of competition in health-care markets,
and the limitation of excessive consolidation throughout the health-
care system.
While the RFI refers to this comment solicitation as ``informal,''
responses to the RFI's wide-ranging questions--addressing Medicare,
Medicaid, and other sources of payment--may ``lay the groundwork for
future action.'' It is critical that HHS maintain transparency when
exchanging information that may shape HHS' future policy decisions and
actions.
If confirmed as HHS Secretary, will you commit to publishing all
future RFIs in the Federal Register?
Will you commit to making stakeholder comments submitted in
response to the ``Promoting Healthcare Choice and Competition Across
the United States'' RFI publicly available in a timely manner?
Answer. I am firmly committed to ensuring that any regulatory
actions taken by the Department comply with the Administrative
Procedure Act (APA). If confirmed, I will review this issue and take
any steps that are necessary to ensure that the Department complies
fully with requirements for RFIs.
Medicaid Expansion and Mental Health
Question. In 2010, the Affordable Care Act (ACA) dramatically
expanded coverage for needed mental health services by giving States
the opportunity to extend Medicaid eligibility to low-income, non-
elderly adults. Of the 11 million adults who subsequently gained
coverage through 33 State Medicaid expansion programs (including the
District of Columbia's), one in three beneficiaries had a substance use
disorder, mental health condition, or both. As a result, over a million
people with substance use disorders gained coverage for treatment under
the Medicaid expansion.
This prominent role in expanding access to mental health and
substance use disorder services has made Medicaid a vital tool in the
national fight against the opioid epidemic. Today, Medicaid is the
single largest payer of substance use disorder services in the Nation,
covering one of every three Americans battling opioid dependence.
States that have shouldered the brunt of the crisis have relied heavily
on the Medicaid expansion to give people access to needed services. In
Kentucky, Maine, Pennsylvania, Ohio and West Virginia, for example,
Medicaid pays for 35 to 50 percent of all Medication-Assisted-
Treatment.
In 2017, legislation was repeatedly introduced to roll back Federal
funding for the Medicaid expansion and to eliminate States' authority
to expand Medicaid eligibility to low-income, non-elderly adults. Would
you oppose future proposals to roll back or eliminate Medicaid
expansion, understanding that such proposals would cripple the Nation's
ability to combat the opioid crisis?
Do you agree that the Medicaid expansion has helped States address
the opioid epidemic by connecting individuals to substance use disorder
services? Please answer ``yes'' or ``no.''
Answer. Medicaid is a safety-net program that provides life-saving
medical care to millions of Americans facing some of the most
challenging health circumstances. In addressing the diversity and
complexity of Medicaid recipients, we have a duty to ensure the highest
level of quality, accessibility, and choices for Americans who rely on
the program. For that reason, it is crucial for States to have the
flexibility to tailor the Medicaid program to meet the needs of their
constituents. If confirmed, I will work to ensure that States are
empowered to tailor solutions that work for their citizens with
substance use disorders and that they receive the proper supports from
their Federal partner at HHS.
1115 Demonstration Projects
Question. Recent comments and guidance from the Centers for
Medicare and Medicaid Services (CMS) indicate that the agency may be
willing to approve proposed section 1115 demonstration projects that
would restrict access to essential benefits and services through the
Medicaid program. These include proposals to impose work requirements,
time limits, mandatory drug testing, burdensome reporting requirements,
and other onerous premium and cost-sharing requirements on Medicaid
families. By limiting access to health care for beneficiaries, these
restrictive conditions on eligibility run counter to congressional
intent and the statutory objectives of the Medicaid program, which
Congress created in 1965 to enable States to provide medical assistance
and long-term care to those who lack the resources to obtain the
services they need.
Will you commit to rejecting any proposed section 1115
demonstration project that undermines the objectives of the Medicaid
statute by reducing access to health services and benefits, including
proposals to impose work requirements on Medicaid beneficiaries? If
not, please explain.
Answer. Medicaid is a single program dealing with many completely
different population subgroups, including for the first time under the
expansion, able-bodied adults without children. We need to customize
our programs and benefits to the characteristics of our beneficiaries.
While I have not been involved as a nominee in CMS efforts to allow
States to implement work requirements in their Medicaid programs, I do
believe there is significant evidence that one of the best ways to
improve the long-term health of low-income Americans is to empower them
with skills and employment, for those who are able to work. If
confirmed, I look forward to working with States to give them
additional flexibility, while holding them accountable to ensure
patient access to high quality health care.
Section 1332 State Innovation Waivers
Question. Section 1332 of the Affordable Care Act (ACA) provides
the Secretary of the Department of Health and Human Services (HHS) with
broad authority to approve State waivers to certain ACA marketplace
provisions. To obtain these State Innovation Waivers, States must
satisfy substantive and procedural safeguards. Waivers must ensure that
individuals get insurance coverage that is at least as comprehensive as
provided under the ACA; the coverage offered is at least as affordable
as it would be under the ACA; as many people are covered as would be
under the ACA; and the waiver does not increase the Federal deficit.
States must also take procedural steps to be eligible for a waiver,
including: providing a public notice and comment period for the
application; enacting a State law for the implementation of the waiver;
and submitting a comprehensive application to HHS.
Describe the opportunities you see for States to use State
Innovation Waivers. Specifically, are there particular State-led
reforms that you think would enhance access to affordable, quality
coverage?
What precautions would you put in place to ensure consumers are
protected in States that choose to move forward with a section 1332
waiver application?
What steps would you take to implement this provision, as intended
by Congress, to ensure it is not used to undermine the ACA?
Describe how you envision State Innovation Waivers working in
conjunction with Medicaid and any corresponding Medicaid waivers.
Specifically, what checks would you put in place to ensure that
individuals entitled to Medicaid receive the full benefits and
protections afforded them under title XIX?
In 2017, multiple proposals were introduced to modify section
1332's substantive and procedural guardrails. Would you support
legislative efforts to weaken these safeguards? If so, cite which
guardrails, in your view, could be modified without sacrificing all
consumers' access to affordable, comprehensive coverage.
Answer. State-driven innovation must be a top priority for the
Department. The ACA has very stringent requirements related to 1332
waivers that limit State flexibility and significantly lengthen the
waiver approval process. I support continued efforts to use CMS's
statutory waiver authorities to test and evaluate demonstrations that
can lower health-care costs or improve quality. These need to be
approached carefully to avoid the potential for waste, fraud, and
abuse, and preserve patient protections, but an unwillingness to
examine these areas makes us penny-wise and pound-foolish too often. If
confirmed, I will work closely with CMS to ensure the continued support
and the timely review of all State 1332 waivers received by HHS, and to
make the waiver approval process more transparent, efficient, and less
burdensome to the extent authorized by law.
Association Health Plans and Short-Term Limited-Duration Plans
Question. As part of the administration's campaign to undermine the
Affordable Care Act (ACA), the President issued an executive order on
October 12, 2017 that directed the Departments of Health and Human
Services (HHS), Labor, and the Treasury to expand the use of
association health plans (AHPs) and short-term
limited-duration insurance. On January 4, 2018, the Department of Labor
(DOL) released proposed rules to expand the availability of AHPs and
enable these plans to bypass certain consumer protections under the
ACA, including the ACA's requirement that plans cover essential health
benefits. If finalized, these rules would make it easier for small
employers and individuals to buy cheap AHP plans substantially less
comprehensive than policies offered under the ACA.
If finalized, DOL's recent AHP rule may destabilize the individual
and small group marketplaces and drive up the cost of ACA-compliant
plans. This is because AHPs will draw younger and healthier consumers
out of those markets, leaving older and sicker individuals behind.
If this rule as proposed is finalized, how would you prevent this
expansion of AHPs from driving up the cost of coverage for individuals
with pre-existing conditions in the individual and small group
marketplaces?
Despite AHPs' history of mismanagement and abuse, DOL's regulation
would give the Federal Government greater oversight authority over
self-insured AHPs. If this rule as proposed is finalized, how would
you, as HHS Secretary, ensure that fraudulent AHPs do not expose
consumers to inadequate coverage and medical debt?
Answer. Millions of consumers in too many State marketplaces have
already lost the plans they liked and the doctors they liked under the
ACA. Large employers often are able to obtain better terms on health
insurance for their employees than small employers because of their
larger pools of insurable individuals across which they can spread risk
and administrative costs. Expanding access to Association Health Plans
(AHPs), which can sell insurance across State lines, can help small
businesses overcome this competitive disadvantage by allowing them to
come together in larger groups to self-insure or purchase large group
health insurance. This approach can reduce administrative costs,
increase bargaining power, and create new economies of scale,
administrative efficiencies, and better allocation of plan
responsibilities to those with greater expertise designing and
administering health benefits programs. Expanding access to AHPs will
also allow more small businesses to avoid many of the ACA's costly
requirements driving millions of Americans into the ranks of the
uninsured, or keeping them there. Expanding access to AHPs would
provide more affordable health insurance options to many Americans,
including hourly wage earners, farmers, professionals who work as solo
practitioners or in small groups, and the employees of small businesses
and entrepreneurs that fuel economic growth. The status quo is not
working for millions of Americans. If confirmed, I will continue to
work within HHS, as well as with the Department of Labor and other
components of the executive branch, to create an affordable, accessible
health insurance system that is responsive to the needs of individuals
and their families.
Question. The administration has yet to implement the executive
order's directive to expand the availability of short-term limited-
duration insurance. Like AHPs, these plans would segment the market
between healthy and sick consumers and drive up the cost of coverage
for individuals with preexisting conditions.
If you are confirmed as Secretary, will you oppose efforts to
expand the availability of short-term limited-duration plans?
Short-term limited-duration plans are permitted to charge
individuals with preexisting conditions more for coverage. Do you think
insurers should be permitted to charge these consumers higher premiums
or cost-sharing requirements?
As HHS Secretary, how would you prevent short-term limited-duration
plans from raising the cost of coverage for individuals with pre-
existing conditions in the individual and small group marketplaces?
Answer. The ACA has already failed millions of Americans who have
lost the plans they liked and the doctors they liked. Short-term
limited duration insurance plans are flexible, adaptable insurance
products that can be particularly useful for those entering the job
market, those transitioning between jobs and other forms of insurance,
or who are otherwise priced out of the unaffordable ACA insurance
markets. Americans need more insurance options, and they need less
Federal micromanagement of their insurance options.
The status quo is not working for millions of Americans--whether it
is those who are in the insurance market or those who have been left
out of it. Although there are many Americans who may not be best served
by a short-term limited duration plan, expanding the availability of
such plans creates affordable options for those who are. If confirmed,
I will work, within HHS as well as with the Department of Labor and
across the executive branch, to create a health insurance system that
is more affordable and responsive to the needs of individuals and their
families so that we have a health-care system that is more affordable
and accessible, where they can choose the type of insurance coverage
that works best for them, including reliable association health plans
and the option of short-term, limited-duration insurance. I will also
work to ensure the least disruptive approach to implementing these
policies, and to appropriately consider the concerns expressed by
stakeholders during the rulemaking process.
Women's Health
Question. The Trump administration has put forth an agenda that
directly undermines women's access to health care, including the
reinstatement of the ``Global Gag Rule'' or ``Mexico City Policy,'' the
termination of funding for the Teen Pregnancy Prevention Program,
restriction of access to birth control, and support for legislative
proposals to end reimbursement for health services provided by Planned
Parenthood.
I request your detailed response to the following:
On October 13, 2017, the administration published two interim final
rules (IFRs) to allow for-profit employers to end coverage of birth
control for their employees based on religious or moral objections,
undermining the Affordable Care Act's (ACA) guarantee that women be
able to access birth control at no out-of-pocket cost. This guarantee
under the ACA is estimated to have saved women more than $1.4 billion
in out-of-pocket costs on birth control per year.
Please answer ``yes'' or ``no.'' Do you believe that all women
should have access to the health care their doctor recommends for them?
Will you rescind these IFRs if you are shown evidence that they
would curtail access to needed contraceptive services for women?
Will you reject any proposal that limits a women's access to
contraceptive care or drives up the cost of birth control?
Will you advise the President to veto any bill that reduces
guaranteed access to affordable contraceptive coverage?
Answer. I believe all women should have access to the care that
they need. We can advance that goal while simultaneously following the
many laws protecting the right of conscience in health care.
Question. In 2016, Planned Parenthood provided preventive care to
over 2.5 million patients--including 1.5 million Medicaid patients.
Over 90 percent of the care Planned Parenthood delivers are preventive
health services, including 360,000 lifesaving breast exams, 270,000 Pap
tests, and 4.3 million tests and treatments for sexually transmitted
infections. Over 54 percent of Planned Parenthood health centers are in
health professional shortage areas or medically underserved areas.
Will you advise the President to veto any bill that rips access to
care away from hundreds of thousands of families by ending Medicaid
reimbursement for Planned Parenthood services?
Answer. Preventive care is important, and I believe women should
have access to such care. If confirmed, I look forward to working with
you to ensure that access to coverage for preventive care is available
for all Americans.
LGBTQ Health Care
Question. LGBTQ individuals often experience exceptional barriers
to care; health disparities associated with gender identity are
partially driven by lower rates of insurance. Under the ACA, the LGBTQ
population cannot be excluded from health plans due to pre-existing
conditions such as HIV. Discrimination based on sex and gender identity
is also prohibited for programs receiving Federal funds. Additionally,
all insurance plans must offer the same coverage to married same-sex
couples as is offered to opposite-sex couples. In terms of national
health surveys, the ACA changed data collection requirements to include
sexual orientation and gender identity, which supports future advocacy
and research.
Will you maintain health-care protections for the LGBTQ community?
Please explain.
Answer. If confirmed, I will do everything in my power to ensure
that all Americans have meaningful access to medical care, including
ensuring that the Department continues to empower patients and
consumers so that they will have increased access to medical care,
health, and wellness. Our Nation's health-care system is founded on the
respect for the human person, evidence-based research, and effective
medical treatment. It must be a system that treats each patient with
the respect that they deserve, in compliance with the law.
The National Registry of Evidence-Based Programs and Practices
Question. It has been reported that the administration has frozen
The National Registry of Evidence-Based Programs and Practices that
provides professionals and community groups with access to a robust
database of independently-assessed,
evidence-based programs for treating mental illness and substance use.
Given that we are in the midst of an opioid crisis that is taxing our
mental health and substance use services systems, policymakers,
community members, and providers are in tremendous need of knowledge
regarding new, evidence-based interventions that are effective in
treating mental health and substance use disorders such as opioid use
disorder.
If confirmed, will you work to reinstate this important registry of
evidence-based interventions including the addition to close to 90
reported programs that were reviewed and rated since September, but
have not yet been added?
Additionally, if confirmed, what will you do to insure that the
National Mental Health and Substance Use Policy Laboratory will make
sure that impartial, nonpartisan, and trustworthy interventions are
promoted by the agency to ensure policymakers, community members, and
providers can benefit from the database in order to help address the
opioid epidemic taking hold across the country?
Answer. I believe in the importance of evidence-based programs and
policies and know that Dr. McCance-Katz, the Assistant Secretary for
Mental Health and Substance Use at SAMHSA, shares this belief. I am not
familiar with the particular reasons why the NREPP contract was
discontinued, but you can be assured that I will maintain HHS's
commitment to evidence-based programs and practices should I be
confirmed.
CDC Guidelines
Question. In your testimony to the committee, you stated that
addressing the opioid crisis would be a top priority for you if you are
confirmed as Secretary. In 2016, the Centers for Disease Control and
Prevention (CDC) released guidelines for prescribing opioids for
chronic pain unrelated to cancer, palliative care, or end-of-life care.
While some health systems and payers have adopted the guidelines, many
have not. For example, according to a Kaiser Family Foundation survey
conducted last summer, the guidelines have been adopted by 23 States
with fee-for-service (FFS) Medicaid programs. Just eight States that
use managed care organizations (MCO) for Medicaid have required MCOs to
adopt the guidelines.
What steps do you plan to take to increase adoption of the CDC
guidelines?
Do you believe that it would be appropriate for the Department to
issue guidance or regulations that would support the adoption of these
guidelines?
Answer. I believe that education of providers is a key component to
addressing the opioid crisis. If confirmed, I would ensure that CDC and
HHS are doing all we can to raise awareness about the guidelines and
encourage adoption of them. I am not sure that guidance or regulations
would be needed to support the adoption of the guidelines, but I commit
to reviewing this, if confirmed.
______
Questions Submitted by Hon. Debbie Stabenow
Question. President Trump's recent executive orders would expand
the use of Association Health Plans and short-term health insurance
coverage, and these plans would not be required to cover the 10
essential health benefits.
Do you support finalizing these rules?
Do you believe that there should be a minimum set of benefits for
anyone buying health insurance in this country? If not, which of the 10
essential health benefits do you believe should be optional?
Answer. The ACA has already failed millions of Americans who have
lost the plans they liked and the doctors they liked. Short-term
limited duration insurance plans are flexible, adaptable insurance
products that can be particularly useful for those entering the job
market, those transitioning between jobs and other forms of insurance,
or who are otherwise priced out of the unaffordable ACA insurance
markets. Americans need more insurance options, and they need less
Federal micromanagement of their insurance options.
The status quo is not working for millions of Americans--whether it
is those who are in the insurance market or those who have been left
out of it. Although there are many Americans who may not be best served
by a short-term limited duration plan, expanding the availability of
such plans creates affordable options for those who are. If confirmed,
I will work, within HHS as well as with the Department of Labor and
across the executive branch, to create a health insurance system that
is more affordable and responsive to the needs of individuals and their
families so that we have a health-care system that is more affordable
and accessible, where they can choose the type of insurance coverage
that works best for them, including reliable association health plans
and the option of short-term, limited-duration insurance. I will also
work to ensure the least disruptive approach to implementing these
policies, and to appropriately consider the concerns expressed by
stakeholders during the rulemaking process.
Question. Prior to the ACA, the vast majority of plans on the
individual market did not offer maternity coverage, and those that did
charged significantly more.
Do you believe that all health plans should be required to cover
maternity and newborn care at no additional cost?
Answer. It is critical that every woman have access to high-quality
prenatal care. If confirmed, I look forward to working with Congress on
the specifics of any new proposals in order to hold States accountable
to ensure patient access to high quality health care.
Question. Because of Medicaid expansion in Michigan, 660,000 people
have insurance and uncompensated care has been cut by at least 50
percent. Thirty thousand jobs have been created and the State will end
the year with $432 million more than it invested in the program.
Did you support the health-care repeal bill this summer that ended
Medicaid expansion?
Do you support block-granting and cutting the Medicaid program?
Would you support cutting Medicaid by $1 trillion, as done in the
current Republican budget?
Answer. We need reforms to give States as much freedom as possible
to design their Medicaid programs to meet the spectrum of diverse needs
of their Medicaid populations. Currently, outdated Federal rules and
requirements prevent States from pioneering delivery system reforms and
from prioritizing Federal resources to their most vulnerable
populations, which hurts access and health outcomes. Reforms like block
grants, when paired with additional authority and flexibility, can
incentivize and empower States to develop innovative solutions to
challenges like high drug costs and fraud, waste and abuse. We must
make health care more tailored to what individuals want and need in
their care. I believe States must have the flexibility to create the
best Medicaid program for their residents and be empowered to be fiscal
stewards of taxpayer dollars. If confirmed, I would support proposals
that would make the Medicaid program work better for the Americans who
rely on it.
Question. Last year, there were 55.5 million total Medicare
beneficiaries, including nearly 2 million in Michigan.
Can you commit to my constituents in Michigan that you will not
propose any cuts to the Medicare program or their benefits in any HHS
budgets during your time as Secretary, if confirmed?
Answer. I take the President's commitment to Medicare beneficiaries
seriously, and, if confirmed, I commit to putting patients first in
whatever Medicare policies we pursue. I will note that any significant
changes to the Medicare Program would need to be passed by Congress. If
confirmed, I will faithfully execute the laws as passed by Congress.
Question. Throughout my career I have worked on both sides of the
aisle to strengthen and grow our country's network of community health
centers, which are uniquely designed to provide access to health care
in the communities that need it most.
How do community health centers fit into your vision of a patient-
centered health delivery system?
Will you work with me and members of this committee on both sides
of the aisle to ensure that we sustain our investment in community
health centers?
Can you share your thoughts about how we can shore up the health
care safety net to ensure no one falls through the cracks?
Answer. It is vitally important that the U.S. health-care system
provide meaningful access to quality medical care, health, and wellness
for all Americans. I am committed to ensuring that community health
centers continue to be funded, so that they can increase access to
primary care. If confirmed, I will work with all members of Congress to
highlight programs like Community Health Centers that can increase
access to quality health care for all. If confirmed, the Department
will work to reduce costs of medical care by increasing the options
that patients and consumers have so that they can be in charge of their
own futures when it comes to their medical care.
Question. CMS recently finalized a new Medicare billing code--code
99483--that physicians and other clinicians can use to be reimbursed
for providing care planning and related services for persons with
cognitive impairment, including Alzheimer's disease and related
dementias.
Now that this code is active, as Secretary, how would you ensure
that providers are aware of the code and provide care planning services
to their patients?
Answer. Assessment and care planning for Medicare beneficiaries
with Alzheimer's disease and other cognitive impairments are critically
important given the challenges facing these individuals. In 2017,
Medicare began making separate payments for physicians and other
practitioners to perform these valuable services. If confirmed, I look
forward to learning more about the education and outreach efforts with
the physician community and other stakeholders who are involved in
these services.
Question. Would you consider examining how cancer hospitals are
reimbursed, particularly the PPS exempt hospitals and consider adding
new facilities that already meet the criteria?
Answer. I understand that the cancer hospital designation under
Medicare is a payment provision specified in statute that, under
current law, excludes hospitals that met specific criteria at a
specific point in time from the Inpatient Prospective Payment System
(IPPS). If confirmed, I stand ready to work with Congress on
legislation to address issues related to the treatment of cancer
hospitals under Medicare.
Question. Recent actions by the FDA in implementing DQSA have
created instances in which 503B compounding facilities are producing
copies of approved drug products. Left unresolved, this issue has the
potential to create marketplaces of inadequately regulated compounded
medications that run counter to the intent of the law. This activity is
concerning for patients in Michigan and for patient safety across the
country considering past history of compounding contamination.
What steps will you take to protect patient safety while also
ensuring access to safe and accessible compounded products for patients
with medical needs not being met by marketed products?
Answer. I appreciate your expressing your support for drugs which
have been through the FDA review and approval process and therefore
receive certain exclusivity protections. It is my understanding that
FDA continues to advance guidance on this and other issues which were
mandated under the 2013 Drug Quality and Security Act, and I will work
with Commissioner Gottlieb to advance these regulations quickly.
______
Question Submitted by Hon. Debbie Stabenow
and Hon. Benjamin L. Cardin
Question. Nearly one in five adults has a mental illness, yet over
60 percent of people with mental illness do not receive treatment.
Mental health parity protections benefit 103 million people today, a
critical step forward. The essential health benefit protections build
on parity by requiring that mental health and substance abuse treatment
are covered by insurance companies.
Do you believe that mental health and substance abuse treatment
should be a guaranteed benefit in all health insurance plans?
What regulations would you pursue, or eliminate, related to Federal
standards for mental health coverage?
Do you support the changes to the Essential Health Benefits
regulations to allow States to choose less comprehensive coverage for
mental health and substance use services?
Answer. It is critical that all Americans suffering from mental
health and substance abuse disorders have access to the care they need.
If confirmed, I plan to review the laws in place on mental health
parity and ensure they are carried out faithfully. Although the
Department of Labor has the primary role in enforcement of the law, I
will be sure to coordinate with them.
______
Questions Submitted Hon. Maria Cantwell
Question. In my office we discussed using Medicare to advance
delivery system reform across the entire health sector. Washington
State health-care providers are paid about $2,000 less per Medicare
patient per year when compared to national averages, according to
Centers for Medicare and Medicaid Services (CMS) fee-for-service data
compiled by the Kaiser Family Foundation. I have long held that
Washington State health providers are essentially penalized for doing a
good job. You have previously said ``We need a next-generation payment
system that rewards innovation, quality, prevention, and improved
patient outcomes--with incentives for good care, not just more care.''
To help me understand what you mean, will you describe at least one
specific example of a current Medicare payment model that you think
shows promise toward achieving those outcomes?
Answer. If confirmed, one of my priorities will be to use the power
of Medicare and Medicaid to drive transformation of our health-care
system from a procedure-based system that pays for sickness to a value-
based system that pays for quality and outcomes. The CMS Innovation
Center is testing many payment and service delivery models that aim to
reduce expenditures and preserve or enhance the quality of care
furnished to beneficiaries. The Innovation Center's Next Generation
Accountable Care Organization (ACO) Model is one example of a current
model that has early promising results. Net savings to the Medicare
Trust Funds was more than $63 million for the first performance year of
the model. In the first year, all Next Generation ACOs successfully
reported on all 33 quality measures and received a 100-percent quality
score.
Question. How will you encourage new Medicare payment and delivery
models to be equitable to physicians and clinicians in low-cost States
like Washington, when the benchmark for success in many of these models
is tied to historical fee-for-
service spending?
Answer. One of my top four priorities as Secretary, if confirmed,
will be to use the power of Medicare and Medicaid to drive
transformation of our health-care system from a procedure-based system
that pays for sickness to a value-based system that pays for quality
and outcomes. It is my understanding that CMS recently issued a Request
for Information seeking feedback on a new direction for its Center for
Medicare and Medicaid Innovation to promote patient-centered care and
test market-driven reforms that empower beneficiaries as consumers,
provide price transparency, increase choices and competition to drive
quality, reduce costs, and improve outcomes. If confirmed, I look
forward to working with CMS as they gather feedback from Congress and
other stakeholders and use it to inform their efforts in developing
payment and service delivery models that meet these goals, including
models that reward providers who are already providing high-quality
care at lowered costs.
Question. As you know, in 2015 Congress passed and President Obama
signed into law the bipartisan Medicare Access and CHIP Reauthorization
Act (MACRA). In implementing MACRA, how will you work with CMS and the
provider community to expand participation in Advanced Alternative
Payment Models (A-APM's)?
Answer. I understand CMS is working to implement MACRA in a way
that ensures meaningful measurement of value and quality while
promoting better patient outcomes and supporting a simplified pathway
to participation in Advanced Alternative Payment Models (APMs). In the
final rule with comment period for the second year of the Quality
Payment Program, CMS updated policies to further encourage and reward
participation in APMs and established policies to further reduce burden
and simplify the program. In addition, it is my understanding that CMS
released a Request for Information \11\ seeking public feedback on a
new direction for the Innovation Center and ways to promote patient-
centered care and test market-driven reforms that empower beneficiaries
as consumers, provide price transparency, increase choices and
competition to drive quality, reduce costs, and improve outcomes. If
confirmed, I look forward to reviewing the comments received and
working on the new direction for the Innovation Center and increasing
the number of Advanced APMs available to clinicians.
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\11\ https://innovation.cms.gov/Files/x/newdirection-rfi.pdf.
MACRA also established the Physician-Focused Payment Model
Technical Advisory Committee (PTAC), to review and assess physician-
focused payment models, a type of APM, based on stakeholder proposals
submitted to the committee. If confirmed, I look forward to reviewing
PTAC's comments and recommendations on these proposals as part of my
work in facilitating CMS's efforts to promote provider participation in
---------------------------------------------------------------------------
Advanced APMs.
Question. One example of delivery system reform we discussed is
``rebalancing'' individuals who require long-term services and supports
(LTSS) from institutional care settings, such as nursing homes, to
home- and community-based settings. I believe that advancing such
rebalancing policies holds the promise to improve quality of life for
patients and save billions of dollars. In Washington State, evidence
shows that 15 years of rebalancing work in our State's Medicaid program
has yielded more than $2.5 billion in savings. I also believe that
Federal incentives can help States accelerate rebalancing policies. I
helped secure the Balancing Incentive Program in the Affordable Care
Act, which 18 States have used to successfully lower their rates of
institutional long-term care for their Medicaid beneficiaries. In
addition, Senator Portman and I recently introduced legislation (S.
2227) to reauthorize the Money Follows the Person (MFP) demonstration
program for 5 years and make improvements in the program. According to
an HHS report, the MFP program has already saved approximately $1
billion in Medicare and Medicaid expenditures in recent years by
helping States to rebalance Medicaid beneficiaries. If confirmed, will
you work with me, my office and other interested members and
stakeholders to advance these rebalancing policies?
Answer. Yes, I look forward to working with you and your office on
these important efforts to support home and community-based care. I
believe that the use of innovation and evidence-based practices will be
a critical part of meeting the evolving needs of older Americans by
supporting programs that provide long-term services and supports in
community-based settings. If confirmed, I will remain deeply committed
to ensuring access to high-quality, community-based supports and
services so that older adults have more and better options about how
and where to receive the services they need. Maintaining the
Department's ongoing efforts through the Centers for Medicare and
Medicaid Services and Administration for Community Living to work with
States in ensuring the right balance of public funding for home and
community-based options for older adults and people with disabilities
will be a priority for me. To do that most effectively and efficiently,
we have to work together across all levels of government and with all
potential partners to establish innovative strategies for meeting these
goals.
Question. On October 23, 2017, I wrote a letter with Senator
Grassley to Acting Secretary Hargan regarding Medicare Part B coverage
for people with lymphedema. Our letter requested that HHS use its
discretionary authority to cover compression therapy supplies for
Medicare patients with lymphedema, or provide us with an explanation
for HHS's inability to do so. On November 30, 2017, CMS Administrator
Verma replied to me indicating that CMS staff was in the process of
exploring whether such coverage was possible under Medicare Part B. If
confirmed, will you work with CMS to provide me and Senator Grassley a
clear and detailed explanation for the decision that CMS ultimately
reaches?
Answer. Medicare was first established more than 50 years ago, with
a siloed approach to determining what would and would not be covered.
It is important to make sure that we are not being short sighted and
failing to cover a treatment or item that will improve health and save
money simply because it does not fit into a category in Medicare. If
confirmed, I would be happy to work with you and Senator Grassley and
with CMS to explore whether separate coverage of and payment for
compression garments is possible under the Medicare Part B benefit
categories established in the statute.
Question. The vast majority of Washington State counties are
primary care or mental health Professional Shortage Areas (HPSA's)
according to HHS's HRSA. In response to an aging population and
impending physician shortages, two new medical schools have opened in
Washington, each focused on training more physicians to practice in
shortage specialties and in medically underserved communities. Do you
agree with an established body of research illustrating that the United
States faces a major doctor shortage?
Answer. The Federal Government has invested in workforce training
and is committed to continuing its work in this area. If confirmed, I
believe it is critical that we look at ways to better address the
workforce shortages.
Question. Given your experience in health-care policy, what is your
view of the role the Federal Government should play to promote an
adequate and balanced physician workforce in the United States?
Answer. As mentioned above, I believe addressing the workforce
shortage is critically important. If confirmed, I commit to reviewing
the budget and ensuring that the programs in place are effective and
meet the goals we set forth.
Question. Medicare's GME program was created in 1965, when we had a
very different health care delivery system than we do today. In what
ways should GME funding programs adapt to the evolving nature of
medical education and care delivery?
Answer. Under the Medicare program, teaching hospitals or hospitals
that train residents in approved medical allopathic, osteopathic,
dental, or podiatry residency programs receive direct graduate medical
education payments that reflect the direct costs of operating approved
residency training programs. Within the statutory parameters of these
payments, there are programs designed to support physician training in
areas with primary care shortages. For example, the Rural Training
Track programs allow urban and rural hospitals to partner to train
resident physicians in rural areas. If confirmed, I look forward to
working with Congress to support health workforce training that
develops practitioners in professions with pronounced shortages and in
underserved areas. I would also look forward to speaking with you
further about your insights regarding ways in which the program may not
have kept up with the evolving nature of medical education and care
delivery.
Question. In recent years some States have sought permission from
CMS to exclude high-quality family planning providers from their
Medicaid programs for ideological reasons. What is your view of whether
the Federal Medicaid statute and regulations permit such exclusions?
Answer. If confirmed, I would work closely with CMS and the Office
of General Counsel to review the relevant statutory and regulatory
Medicaid participation requirements invoked in your question. As a
general matter, if confirmed, I will work to promote a health-care
system that will provide access to quality care while ensuring patients
are able to make decisions that work best for them. Additionally, I
will also work with States to help them achieve their goals with as
much flexibility as possible, within the parameters and confines of the
law.
Question. Will you commit to providing me and my office timely and
responsive technical assistance on any future legislation I author or
on which I seek assistance?
Answer. Yes, I will commit to working with my staff to facilitate
their provision of appropriate technical assistance on future
legislation.
______
Questions Submitted by Hon. Bill Nelson
Question. I want to get your perspective on some of the policies
supported by your predecessor, Secretary Price. Please answer with a
``yes'' or ``no.''
Do you support raising the Medicare eligibility age, forcing
seniors to wait longer for benefits they earned during their working
years?
Do you support turning Medicare into a voucher program? According
to CBO estimates, privatizing Medicare would increase premiums paid by
seniors by 30 percent.
Do you support allowing Medicare providers to enter into private
contracts with their patients? This would place seniors on the hook for
the difference between what an insurer pays and what a provider
charges, potentially resulting in higher out-of-pocket costs for
patients.
Answer. The mission of HHS is to enhance and protect the health and
the well-being of all Americans, through programs that touch every
single American in some way, every single day. As Secretary, my job
would be to lead HHS in its work towards this mission.
Ultimately, the direction of Medicare is up to Congress and, if
confirmed as HHS Secretary, I will follow the laws as passed by
Congress and implement them accordingly.
Question. In Florida, over 3.5 million people, including children,
seniors, and those with disabilities rely on Medicaid and CHIP. Another
800,000 would have gained access to Medicaid services had Florida
expanded Medicaid.
Medicaid is particularly important to hurricane recovery efforts.
As it is currently structured, Medicaid can respond to public health
emergencies and natural disasters. As needs go up in a State, Federal
funding goes up automatically in response. After going through three
hurricanes in a matter of weeks, I am really worried about how Florida,
Puerto Rico and the U.S. Virgin Islands will fare under ``entitlement
reform.'' Puerto Rico's Medicaid program is already subject to a block
grant that won't adjust for the greater demand as the island recovers
from the hurricane, and they're expected to run out of money in a
month. To me, there is no better example of why block granting Medicaid
just won't work.
How do block grants and caps provide States with enough funding to
respond to natural disasters like Hurricanes Irma or Maria? Block
grants provide a fixed dollar amount and caps provide a fixed about of
funding per individual. What happens when more people need health
coverage or costs rise on a per-beneficiary basis?
Answer. I am certainly aware of the unique challenges that the
Puerto Rico Medicaid program faced even before the hurricane. Of
course, these challenges are compounded following such a serious storm.
As I noted before the committee, the details around financing and
flexibility are key to evaluating any block grant reform approach,
including those proposed last year. Medicaid is a single program
dealing with many completely different population subgroups, including
for the first time under the expansion, able-bodied adults without
children. We need reforms to give States as much freedom as possible to
design their Medicaid programs to meet the spectrum of diverse needs of
their Medicaid populations. Currently, outdated Federal rules and
requirements prevent States from pioneering delivery system reforms and
from prioritizing Federal resources to their most vulnerable
populations, which hurts access and health outcomes. Reforms like block
grants, when paired with additional authority and flexibility, can
incentivize and empower States to develop innovative solutions to
challenges like high drug costs and fraud, waste, and abuse. We must
make health care more tailored to what individuals want and need in
their care. I believe States must have the flexibility to create the
best Medicaid program for their residents and be empowered to be fiscal
stewards of taxpayer dollars. If confirmed, I would support proposals
that would make the Medicaid program work better for the Americans who
rely on it.
Question. I introduced a bill that, similar to steps taken
following Hurricane Katrina, has the Federal Government pick up 100
percent of Medicaid costs temporarily so that Puerto Rico and the U.S.
Virgin Islands can recover from the hurricanes. The islands have
limited ability to cover their share of Medicaid funds needed to draw
down Federal dollars, and my bill would help them in their hour need.
Would you recommend that HHS support such a policy?
Answer. I am certainly aware of the unique challenges that the
Puerto Rico Medicaid program faced even before the hurricane. Of
course, these challenges are compounded following such a serious storm.
Much of the Medicaid funding can only be addressed by Congress, and, if
confirmed, I stand ready to assist Congress.
Question. My office has heard multiple reports that the FDA is not
only seizing prescription drugs ordered by Floridians from outside of
the United States, but is also raiding Florida storefronts that
reportedly provide mostly seniors in-person assistance with buying
necessary prescription medications from Canada and other countries.
While I appreciate that the importation of foreign prescription
drugs is illegal under most circumstances to control the safety of our
supply the chain, the Federal Government announced in 2006 that it
would stop seizing small amounts of prescription drugs ordered from
Canadian pharmacies.
That announcement was put in place at my urging, and it has allowed
U.S. residents--again, mainly seniors--to save on the cost of their
prescription drugs by ordering them online from pharmacies in Canada,
instead of filling them at pharmacies in the United States.
To the best of my knowledge, no new FDA policies have been
announced, yet these reports suggest a major shift in policy. I
appreciate the need to keep dangerous drugs like fentanyl and
counterfeit pharmaceuticals out of our country, but my constituents are
confused about why they're receiving a seizure notice instead of their
necessary medications.
Are you aware of this issue? Is there anything HHS can do to help
shed light on what's going on in Florida?
Do you know if there has been a change in policy? I sent a letter
to the FDA last month asking that same question, and I have yet to
receive a response.
Do I have your commitment that, if confirmed, you will help get to
the bottom of this?
Answer. I appreciate your bringing this issue to my attention. If
confirmed, I will work with the FDA to provide answers to your
questions.
Question. The opioid crisis is devastating families across the
Nation. In Florida alone, 5,275 opioid-related deaths were reported in
2016--35 percent more than reported in 2015. Fentanyl killed 1,390
Floridians, nearly double the 705 Floridians killed by fentanyl a year
before. I've long said that we need a comprehensive approach to prevent
and treat the opioid epidemic before more lives are lost. But we can't
do that without investing sufficient resources so that our communities
can fight back.
As the President's chief advisor on issues like these, would you
advise him to work with Congress to ensure that State and local
governments receive the funding they need to fight the opioid crisis?
Answer. I know that the President is committed to fighting the
opioid epidemic. He has made it a top priority of the administration,
and I look forward to working with him and Congress to ensure that
State and local governments are equipped with the tools they need to
fight the opioid crisis.
Question. I am an original cosponsor of the Combating the Opioid
Epidemic Act, which would appropriate about $45 billion to address the
opioid epidemic. This is the same amount of funding proposed by Senate
Republicans as part of the ACA repeal. Do you believe that more Federal
funding assistance is necessary to improve the response to the
epidemic?
Answer. If confirmed, I look forward to working with Congress to
ensure that we are well-equipped to fight the opioid epidemic.
Question. What actions will you take, if confirmed, to improve the
agency's response to the epidemic?
Answer. The opioid epidemic is a top priority at the Department. If
confirmed, I look forward to being briefed on all the activities
already underway and learning what we need to do to work more
collaboratively and push forward solutions to this crisis.
Question. The Affordable Care Act includes a number of provisions
designed to help improve and increase treatment for individuals
addicted to opioids. For example, it requires health plans offered
through the ACA marketplace to cover substance use disorder treatments
as an essential benefit. The law also prohibits insurers from
discriminating against folks with pre-existing conditions, including
addiction. Yet my Republican colleagues tried repeatedly to undermine
these protections as part of larger ACA repeal efforts. Do you support
these provisions?
Answer. I believe that Americans should have access to the health
care they need. I defer to Congress on how this should be achieved. As
I have said, I believe that individuals with opioid use disorder should
have access to treatment and recovery services. If confirmed, I look
forward to ensuring that the Department is doing all it can to promote
and advance treatment for individuals addicted to opioids.
Question. The ACA also expanded Medicaid, the single largest payer
of substance abuse services in the country; an action that the State of
Florida refuses to take despite the fact that it could help over
800,000 Floridians and bring billions to the State's economy.
Expansion aside, Medicaid plays a critical role in the fight
against the opioid epidemic. Changing the Medicaid program through
block grants or caps will shift costs to States, eliminate critical
Federal protections, and hurt the more than 3.5 million Floridians who
rely on the program, including those addicted to opioids.
Do you support these cuts to the Medicaid program through block
grants, caps, or other proposals? If those cuts are made, how do you
propose States like Florida provide the necessary services to help
individuals with substance use disorders?
Answer. As I said above and before the committee, the details
around financing and flexibility are key to evaluating any block grant
reform approach, including those proposed last year. We need reforms to
give States as much freedom as possible to design their Medicaid
programs to meet the spectrum of diverse needs of their Medicaid
populations. Currently, outdated Federal rules and requirements prevent
States from pioneering delivery system reforms and from prioritizing
Federal resources to their most vulnerable populations, which hurts
access and health outcomes. Reforms like block grants, when paired with
additional authority and flexibility, can incentivize and empower
States to develop innovative solutions to challenges like high drug
costs and fraud, waste and abuse. We must make health care more
tailored to what individuals want and need in their care. I believe
States must have the flexibility to create the best Medicaid program
for their residents and be empowered to be fiscal stewards of taxpayer
dollars. If confirmed, I would support proposals that would make the
Medicaid program work better for individuals with substance use
disorders and all Americans who rely on it.
Question. Over 5,613 cases of Zika virus have been reported across
the U.S. States and territories. No State has been hit harder by the
Zika outbreak than Florida. The State has seen more than 1,708 reported
cases of the Zika virus to date and reported 239 new cases of Zika in
2017. Last year, I fought to secure funding to address the Zika crisis.
Unfortunately, the administration's 2018 proposed budget slashed many
of the very programs Congress voted to fund in 2016 so they could help
prevent, control, and research the spread of Zika.
The administration is expected to release a new budget for 2019 in
the coming months. I want to know whether you support the cuts to
programs and agencies critical to defending our constituents from the
Zika virus, and other vector-borne diseases in 2018? Would you
recommend that the administration make similar cuts in its 2019
proposed budget?
It took months since President Obama made his initial request for
Congress to strike a deal to provide $1.1 billion to fight Zika. That
delay is simply unacceptable, and we know better than to expect
infectious diseases to stop with Zika.
Last year, I joined Senators Cassidy and Schatz in introducing a
bill to fund the nearly empty Public Health Emergency Fund through
mandatory appropriations designated as emergency spending modeled after
FEMA's disaster relief fund.
Do you support the creation of an emergency health fund to provide
mandatory appropriations to fight Zika and other infectious diseases?
Do you have a better solution to respond to these threats and to avoid
the months of partisan roadblocks we encountered?
Answer. I was not at the Department during the development of the
FY 2018 President's budget, so I am unable to comment on the basis for
the budget decisions that are embodied in that document. Likewise, with
respect to the FY 2019 President's budget, if the schedule for
preparation of the budget is similar to the schedule followed when I
was Deputy Secretary, most of the decisions with respect to the FY 2019
budget have already been made, given that it is likely to be released
early in February of this year, so even if confirmed, I am unlikely to
have any opportunity for input on the FY 2019 budget. I do understand
that developing the 2018 budget required the Department to make tough
choices about HHS programs and administration priorities. The 2018
budget proposed to support priority activities within an overall lower
level that reflected a new approach to long-term fiscal stability
across the Federal Government. It is also my understanding that the FY
2018 President's budget proposed a Federal Emergency Response Fund to
enable the Department to address emergency situations, including to
prevent, prepare for, or respond to an emerging infectious disease--the
very situation that you identified. I understand that the FY 2018
budget also included a proposal for an enhanced transfer authority in
emergencies, so that the Department would not need to wait for an
emergency supplemental appropriation before it could begin responding
to the emergency situation.
Question. I have long been a supporter of the Maternal, Infant, and
Early Childhood Visitation program (MIECHV). The MIECHV program,
enacted as part of the Affordable Care Act, aims to help States have
the capability to provide in-home visits to at-risk parents and
families to ensure that families remain united and children's
developmental and early education needs are met. The program was last
reauthorized for 2 years in 2015, and its authorization expired on
September 30, 2017.
In Florida, the MIECHV program is implemented through public-
private partnerships, with 27 sites around the State. They receive $11
million annually to support home visiting programs.
There have been bipartisan efforts to extend the funding for
MIECHV, including S. 1829, of which I am a cosponsor. Reauthorization
language has also been introduced in the House, however House
Republicans have been advocating for several problematic policy changes
including a State match requirement. This would put States on the hook
for funding part of the program and many may be unable to meet this
obligation, putting the program at risk should States not have enough
funding to keep it going.
Do you support preserving this important evidence-based program and
ensuring families have access to it?
If confirmed, would you oppose efforts to require States to provide
matching funds in order to access Federal MIECHV dollars?
Answer. If confirmed, I look forward to working with members of
Congress from both sides of the aisle on the reauthorization of the
Maternal, Infant, and Early Childhood Home Visiting Program.
Question. The ACA reauthorized the Minority Centers of Excellence
(COE) program, housed within the Department of Health and Human
Services. The Florida Agricultural and Mechanical University (FAMU)
Pharmacy, located in Florida, is a grantee. COE supports curriculum-
based initiatives for increasing minority and underrepresented
individuals to become health professionals.
Do you support preserving important programs like COE, Health
Careers Opportunities Program, and Area Health Education Centers?
Answer. Encouraging minorities and other underrepresented
individuals to become health professionals is an important piece of
helping to address the shortage of health professionals across the
health-care spectrum. If confirmed, I look forward to being briefed and
learning more about these programs and others aimed at increasing
minority health professionals.
Question. In 2015, the Precision Medicine Initiative (PMI) was
launched, a research effort designed to advance biomedical discoveries
and accelerate the development and delivery of optimal, tailored
treatments to all patients. The All of Us Research Program (formerly
Precision Medicine Initiative Cohort Program) will build a national
research cohort of at least 1 million volunteers who will participate
in a longitudinal effort to identify the factors that contribute to
disease.
In September 2015, the Precision Medicine Initiative Working Group
of the Advisory Committee to the Director recommended that NIH consider
how to best incorporate necessary safeguards to ensure appropriate
enrollment, retention and protections for children and other special
populations.
In July of 2017, NIH launched the Child Enrollment Scientific
Vision Working Group (CESVWG), which was charged with supporting the
program's efforts to develop the approach for including pediatric
populations. The CESVWG was tasked with releasing a report, which is
pending. In September that same year, the CESVWG sought public input to
inform its work. The CESVWG is the first of two groups; the second work
group will examine the practical considerations of child enrollment and
data collection involving children.
If confirmed, will you work with NIH to provide a timely update
regarding the following:
The date for the release of the report from the Child
Enrollment Scientific Vision Working Group;
The expected date for impaneling the second work group on
child enrollment and data collection involving children;
The targeted number of children for enrollment in the All of
Us Research Program; and
How enrollment will include participation from pediatric
health systems with experience in pediatric clinical trial
enrollment?
Answer. Yes, I commit to working with NIH to provide you with
updates on these issues.
Question. For the past several sessions of Congress, I have
introduced the Resident Physician Shortage Reduction Act of 2017
(S.1301), which would increase the number of residency positions
eligible for Medicare GME support. The legislation would increase the
number of residency slots nationally by 3,000 each year, from 2019
through 2023, for a total of 15,000 slots. The creation of these slots
would ensure that America remains at the forefront of biomedical
research and medical education. Senator Heller and I have introduced
this bill in a bipartisan manner.
Medicare funding for training doctors has historically been stable
and reliable, and should remain so. Our teaching hospitals and the
pipeline of physicians are too important to put at risk. In fact, we
need to pass S. 1301 and increase the level of support for GME in this
country.
Can you describe how, as Secretary of Health and Human Services,
you would ensure that funding for GME and America's teaching hospitals
is protected and expanded?
Answer. Under the Medicare program, teaching hospitals or hospitals
that train residents in approved medical allopathic, osteopathic,
dental, or podiatry residency programs receive direct graduate medical
education payments that reflect the direct costs of operating approved
residency training programs. Within the statutory parameters of these
payments, there are programs designed to support physician training in
areas with primary care shortages. If confirmed, I look forward to
working with Congress to support health workforce training that
develops practitioners in professions with pronounced shortages and in
underserved areas.
Question. Mr. Azar, last year, CMS proposed a new payment model for
Medicare's home health patients. The proposed model from CMS, called
the Home Health Groupings Model, has never been piloted or
demonstrated. I, along with many other Senators and House members,
wrote to CMS to let them know that we had heard from stakeholders who
were concerned that the proposed rule lacked enough information to
allow home health agencies to accurately estimate the model's impact.
Thankfully, the Department did not finalize the policy as proposed,
citing a need for more stakeholder input.
Are you familiar with the importance of home health in our Nation's
health-care system, and can you commit to moving forward with the
stakeholder involvement process?
Answer. Providing Medicare beneficiaries access to quality care in
a setting that works best for their individual needs is an important
priority for the program and for me. If confirmed, I look forward to
working with stakeholders to better understand their perspective on CMS
regulations, in particular those affecting home health care.
Question. Amyotrophic Lateral Sclerosis or ALS is a progressive
disease that gradually leads people to lose control of their muscles.
They may stop walking, speaking, eating, moving, or even breathing. To
date, there is no effective treatment or cure for ALS. Most important
is that the incidence of ALS in the military is twice that of
civilians. It affects as many as 30,000 Americans, and 5,000 new cases
are diagnosed each year.
The Centers for Disease Control and Prevention (CDC) is home to the
ALS Registry, which was created by the bipartisan ALS Registry Act of
2008 signed into law by President Bush. The Registry serves several
critical purposes, including alerting patients with ALS to clinical
trials, as well as fostering collaboration within the Federal
Government. The ALS Registry has received bipartisan support and is
funded with an appropriation of $10 million. Without the registry,
research on ALS would be set back considerably.
Can you provide reassurance that you will do all you can to support
the Registry by requesting funds in the President's 2019 budget?
What else do you think CDC and/or the Department of Health and
Human Services can do to support the fight to find a cure and
treatments for ALS?
Answer. ALS is a serious disease, and I commit to working with the
Department on the registry and finding cures and treatment.
Question. More than 650,000 Americans have ESRD--which occurs when
the kidneys are no longer able to work at a level needed for day-to-day
life--and require dialysis treatment. These individuals typically have
many health problems, are at a higher risk of hospital readmissions,
and receive fragmented care. Individuals with ESRD, regardless of age,
are eligible for Medicare in most cases. In 2012, ESRD beneficiaries
accounted for 1.1 percent of the Medicare pool, but 5.6 percent of
total Medicare spending.
Late last year, I joined Senators Young, Heller, and Bennet in
reintroducing S. 2065, the Dialysis Patient Access to Integrated-care,
Empowerment, Nephrologists, Treatment, and Services (PATIENTS)
Demonstration Act, which would establish a 5-year pilot program where
groups of eligible providers would form an integrated care model to
serve as the medical home for ESRD Medicare beneficiaries.
If confirmed, would you support patient centered models of care
that allow people with ESRD to receive holistic health coverage, like
the model we have created in the PATIENTS Act?
Answer. We share the goal of improving Medicare by empowering
providers to be creative and developing payment models that best suit
the unique needs of their patients to ultimately improve patient care.
If confirmed, I would look forward to working with CMS and Congress in
examining these alternative approaches. As I said in my opening
statement to the committee, we must make health care more affordable,
more available, and more tailored to what individuals need in their
care, including those with very serious chronic conditions such as
ESRD. If confirmed, I will commit to continuing to implement and
enforce the laws within the purview of the Department of Health and
Human Services.
Question. The dialysis facilities were the first to agree to a
value-based performance system and worked closely with the Congress and
CMS to make sure that it worked for patients, physicians, and
providers. However, it is my understanding that the number of quality
programs has expanded to include a duplicative five star reporting
system that uses a different methodology for assessing quality
performance and different measures than the QIP program. Patients have
raised concerns that the dueling programs are confusing and make
decision-making more difficult. MedPAC has urged CMS to eliminate the
five star program and rely upon the Congressionally mandated, publicly
reported QIP.
What will you do to address this problem and reduce the confusion
that patients experience?
Answer. Dialysis Facility Compare on the Medicare.gov website
provides information about the quality of dialysis facilities and
publishes data on thousands of
Medicare-certified dialysis centers across the country. It is my
understanding that CMS added the five star ratings in 2015 to Dialysis
Facility Compare with the goal of improving the usefulness of quality
information for consumers. Star ratings are intended to enhance and
supplement existing publicly reported quality information, which will
continue to be available. Star ratings can help consumers quickly
identify differences in quality when selecting a dialysis facility, as
well as help existing patients understand how CMS measures quality for
this program.
It is important that Dialysis Facility Compare and the Five Star
Rating system meet the needs of individuals with kidney disease and
their caregivers, groups and individuals who advocate on behalf of
kidney patients, health-care providers, and others who may be involved
in helping a patient have a better understanding of the care they
receive. It is my understanding that CMS is continually working on
improvements to Dialysis Facility Compare and the Five Star Rating
system and welcomes stakeholder feedback. I believe patients need
access to high quality, accurate and informative quality data. If
confirmed, I will work with CMS to ensure that beneficiaries can easily
access clear information on the quality of dialysis facilities.
Question. The Department of Health and Human Services has a special
responsibility to ensure that survivors of the Holocaust receive the
specialized care they need.
If confirmed, will you commit to working with me to better support
Holocaust survivors? Also, will you commit to support funding of the
Holocaust Survivor Assistance Fund at a level sufficient to address
survivors' unique needs?
Answer. I am not familiar with the current state of the Holocaust
Survivor Assistance Fund, but I look forward to working with you to
ensure adequate support for Holocaust survivors.
Question. CT colonography (CTC), also known as virtual colonoscopy,
are diagnostic medical tests, which produce detailed images of the
colon by using a combination of 2-dimentional x-rays and a 3-
dimentional computer views. They have the ability to identify lesions
and tumors on the kidneys and other organs and blockages in the
coronary arteries.
Currently, Tricare and all major private payers in the majority of
States (37) cover CT colonography/virtual colonoscopies for colorectal
cancer screening, but Medicare does not.
Will you use your authority as Secretary to consider the addition
of CT Colonography/virtual colonoscopies as a colon cancer screening
option for Medicare beneficiaries?
Answer. If confirmed as Secretary, I will work with Congress and
the CMS team to ensure that the coverage determination process works
well to ensure that Medicare beneficiaries have appropriate access to
items and services reasonable and necessary for diagnosis and treatment
of colorectal cancer.
Question. During the public comment period for the FDA's tobacco
deeming rule, the Small Business Administration's Office of Advocacy
filed concerns that the economic impact analysis conducted by the FDA
was ``deficient'' and should be recalculated. Small business premium
cigar retailers in my State have expressed the same concern to me. To
date, the FDA has taken no action to address these concerns.
Do you believe additional review of the costs of this regulation
should be conducted before any additional implementation?
Answer. That previous analysis was conducted under the prior
administration. While I can't speak to their analysis, if confirmed,
under my leadership the Department and our agencies will ensure our
analysis is complete and incorporates the true impact regulations will
have. I certainly support the steps Commissioner Gottlieb has taken
regarding the regulation of nicotine in cigarettes, and I believe he
shares my view that such regulations must be done in a reasonable way.
Further, it is my understanding that the agency is in the process of
evaluating prior regulatory proposals on premium cigars, and I commit
to updating you on the analysis, if confirmed.
Question. Mr. Azar, as you know the Health Insurance Tax has been
suspended in the past, and could be suspended again. Should you be
confirmed as Secretary, how will you ensure that any savings from any
further suspensions or changes to the tax are fully passed on to
policyholders, including beneficiaries in the Medicare Advantage
program?
Answer. I understand that the Internal Revenue Service is
responsible for the collection of the Health Insurance Tax, but
Congress will ultimately decide whether or not the Health Insurance Tax
remains in effect. If confirmed I stand ready to implement the laws as
passed by Congress.
______
Questions Submitted by Hon. Robert Menendez
Question. Do you believe that repealing the Affordable Care Act
without a workable plan in place is a responsible course of action?
Answer. The President has supported various efforts to replace the
ACA system with other systems that would make insurance more
affordable, available, and tailored to the needs of the individual. The
status quo is not working for millions of Americans--whether it is
those who are in the insurance market or those who have been left out
of it. However, any changes to the Affordable Care Act would need to
come from Congress. My role as HHS Secretary, if confirmed, would be to
faithfully implement the laws as passed by Congress. If confirmed, I
will work, within HHS as well as with the Department of Labor and
across the executive branch, to create a health insurance system that
is more affordable and responsive to the needs of individuals, where
they can choose the type of insurance coverage that works best for
them.
Question. Are you aware of a document of options prepared by HHS
for a March 23, 2017 meeting between then-Secretary Price and members
of Congress? Are you aware of the document listing out ways the
administration can undercut the Affordable Care Act? Is it the role of
the executive branch to undermine existing law or to implement laws as
passed by Congress?
Answer. I am only aware of the contents of this document from
published press reports following Senator Casey's disclosure of the
document. If confirmed, I would remain fully committed to implementing
the laws and regulations that guide our Nation's health-care system. I
look forward to working with Congress on the best way to achieve our
shared goals.
Question. How will you, if confirmed, ensure people will have
insurance that provides comprehensive coverage?
Answer. We must make health care more affordable, more available,
and more tailored to what people want and need in their care. Under the
status quo, premiums have been skyrocketing year after year and choices
have been dwindling. An insurance card is no guarantee of access to
quality care. We must address these challenges for those who have
insurance coverage, and for those who have been pushed out or left out
of the insurance market by the Affordable Care Act.
Question. In your testimony and during the hearing you indicated
support for a model that will give consumer's choice, lower costs, and
access to their choice of provider. What would that model of health
care look like?
Answer. If confirmed, I will work, within HHS, as well as with the
Department of Labor and across the executive branch, to create a health
insurance system that is more affordable and responsive to the needs of
individuals and their families so that we have a health-care system
that is more affordable and accessible, where they can choose the type
of insurance coverage that works best for them including reliable
association health plans and the option of short-term, limited-duration
insurance.
Question. Do you believe charity care and community health centers
can provide lower-income Americans the care they need to maintain their
health and lead successful, productive lives? In fact didn't you say on
the Fox Business Network in March, ``That's one of the beauties and has
been for the longest time of our system, that we really do take care of
those who can't afford to have insurance. They still have access to
care. Listen, it's still better for people to have insurance.''
Rather than support people having access to preventive care, you
think having those without insurance rely on charity care, community
health care centers, is a better use of Federal resources?
Answer. If confirmed, I look forward to working to find ways to
make health care more affordable, available, and tailored to what
individuals want and need in their care. I will support community
health centers that deliver comprehensive, affordable, high-quality
primary health-care services, including preventive health services, to
nearly 26 million people nationwide and make services available to
residents of their service area regardless of ability to pay.
Question. As you may be aware, funding for Community Health Centers
lapsed in September and the last CR provided temporary funding.
Do you support strong funding for health centers?
What will be your strategy to ensure they have the funding and
support needed to continue to thrive in their communities?
Answer. I am committed to working with Congress to ensure that
community health centers continue to be funded, so that they can
increase access to primary care. If confirmed, I look forward to
working to find ways to make health care more affordable, available,
and tailored to what individuals want and need in their care.
Question. You previously criticized the ACA's Medicaid expansion.
The Medicaid expansion was critical to expanding health care coverage
to millions of Americans, including over half a million in New Jersey.
Do you have a workable solution to provide coverage to the millions
of Americans who will lose their coverage if Medicaid expansion is
repealed?
Do you think, especially with the changes to the tax bill, that
charity care can fill that gap nationwide?
Answer. Medicaid is a single program dealing with many completely
different population subgroups, including for the first time under the
expansion, able-bodied adults without children. We need to customize
our programs and benefits to the characteristics of our beneficiaries.
If confirmed, I look forward to working with States to give them
additional flexibility, while holding them accountable to ensure
patient access to high quality health care.
Question. The Affordable Care Act remains the law of the land--will
you ensure that law if followed or will you work to undermine it and
rip health insurance away from millions of Americans.
Answer. Any significant changes to the Affordable Care Act would
need to come from Congress. If confirmed, I will faithfully execute the
laws as passed by Congress with the goal of making insurance as
affordable, available, and tailored to the needs of the individual as
is possible within the statutory constraints of the ACA. As I have said
previously, we need a health insurance system that is responsive to the
needs of individuals and their families, and the current system is not
working as well as it could or should.
Question. The Autism CARES act has provided invaluable research
funding for autism. This bipartisan legislation expires soon and I plan
on reintroducing the bill in the coming weeks. In that vein, I have
several questions about the commitment of HHS to improving outcomes for
those with autism and other developmental conditions.
The President's HHS budget for FY18 substantially reduced Federal
funding authorized by the Autism CURES Act, which includes training
programs, research, and State systems grants. Will you commit to
funding these programs as Congress intended under the Autism CURES Act,
and to address areas that have been historically underfunded, including
services research?
New Jersey's autism rate is the highest in the country. For
children from lower income families Medicaid, CHIP, and the ACA provide
critical access to care. Do you believe a patchwork of safety net
providers and charity care can adequately provide the services and
support for families with children and adult children who have special
needs?
Access to timely interventions has proven to mitigate autism's
disabling symptoms. However, children of color still lag in their
access to interventions. What will you do to address this?
Every year 50,000 children enter adulthood, losing their school-
based services and aging into adult services funded by Medicaid.
How will you improve outcomes for transition-aged youth that
address the different needs of each youth based on the severity of
their autism?
Answer. I am committed to fully implementing the laws passed by
Congress and would ensure any provisions enacted related to autism are
properly implemented. I believe that all Americans should have access
to the health care they need and look forward to working with Congress
on policies that address this goal. I am committed to ensuring that our
fellow citizens in historically disadvantaged communities, especially
racial and ethnic minorities, have equal access to quality and
affordable medical care, health, and wellness as required by law.
Question. I am deeply concerned about recent cuts to the Prevention
and Public Health fund. It is estimated that half of the CDC
Immunization Program budget is funded with Prevention Fund dollars.
Cuts to the Prevention Fund threaten the remarkable progress we have
made in public health.
As Secretary, will you commit to support and protect vital public
health programs such as immunization, ``yes'' or ``no''?
New Jersey was heavily impacted by the 9/11 terror attacks. The
health consequences of that national tragedy were not immediately
apparent; many of those caught in the terror attack as well as our
first responders have been impacted by the event. My Firefighter Cancer
Registry Act of 2017 would establish a voluntary registry for
firefighters at the CDC to track and collect cancer data. Can I count
on you to work with me to ensure our first responders are able to get
this registry and we can work to minimize the health consequences they
suffer from due to their work?
What actions will you take to ensure that State and local health
departments are properly resourced and equipped to handle routine
immunization outreach and delivery efforts as well as respond to
emergencies and disease outbreaks?
Answer. Vaccines are one of the greatest success stories in public
health and are among the most cost-effective ways to prevent disease. I
know the CDC plays a large role in supporting States, counties, and
city and tribal health departments in their immunization
infrastructure. If confirmed, I look forward to continuing this great
work. I also would be happy to work with you on your bill related to a
firefighter cancer registry.
Question. I am encouraged by provisions in the 21st Century Cures
Act which require CMS's risk adjustment penalties in the Medicare
Hospital Readmissions Reduction Program (HRRP) to account for the
socioeconomic challenges of vulnerable patients. These changes
represent an important step in ensuring equitable reimbursement for
safety net hospitals. As HHS Secretary, how would you build upon the
progress that has been made to better account for social risk factors
in how Medicare pays hospitals?
Answer. Social risk factors play a role in health and health care,
and the issue of how to account for social risk factors in value-based
payment programs has been the subject of recent reports, including by
the Assistant Secretary for Planning and Evaluation in the Department
of Health and Human Services, the National Academies of Sciences,
Engineering and Medicine, as well as a trial done by the National
Quality Forum. Evaluation of this issue is ongoing, and I hope to
review the research and work with stakeholders and Congress to
determine the best and most equitable approach to this difficult issue.
While we should hold providers accountable for achieving outcomes in
value-based payment programs, we must ensure that the quality of care
furnished by providers and suppliers is assessed as fairly as possible
while ensuring that beneficiaries have adequate access to high-quality
care.
Question. Mr. Azar, one of the important protections afforded
families in the ACA is guaranteed maternity coverage. Do you support
women having access to the maternity care they need regardless of
income?
Answer. It is critical that every woman have access to high quality
prenatal care.
Question. Do you feel HHS can take steps to address racial, ethnic,
and socioeconomic disparities in health care? Will you commit to
working with my office on these issues?
Answer. I believe that every person should have meaningful access
to quality medical care. I am committed to ensuring that our fellow
citizens in historically disadvantaged communities, especially racial
and ethnic minorities, have equal access to quality and affordable
medical care, health, and wellness as required by law. If confirmed as
Secretary, under my leadership the Department will work to reduce
unequal access to quality medical care through vigorous enforcement of
our civil rights laws and through evidence-based analysis of health-
care disparities and attention to the causes of such differences in
people's health.
Question. Senator Grassley and I introduced our Maternal, Infant,
and Early Childhood Home Visiting Program reauthorization bill last
year and unfortunately the program's authorization lapsed after
September. Can I count on your support for the MIECHV program?
Answer. If confirmed, I look forward to working with members of
Congress from both sides of the aisle on the reauthorization of the
Maternal, Infant, and Early Childhood Home Visiting Program.
Question. Mr. Azar, is Roe v. Wade the law of the land?
Answer. Roe v. Wade and its progeny, as currently interpreted by
the Supreme Court of the United States, are controlling Federal
precedents.
Question. Do you recognize that as Secretary of HHS you must apply
the law and not what you wish the law to be?
Answer. Yes. If confirmed, I will consider the advice of the Office
of the General Counsel when interpreting and applying the law.
Question. The Office of Refugee Resettlement has been in the news
lately for their denial of access to those in their custody to
reproductive services.
Will you commit to reviewing ORR policy to prevent undue delays for
the individuals seeking to access reproductive health care services?
ORR Director Lloyd has personally intervened in these cases. Do you
have concerns that his actions violate Flores v. Reno--which requires
ORR to provide emergency health care and family planning services to
those in their custody?
Can you commit to ensuring ORR is not wasting Federal resources to
countermand established law? Can you commit to providing this committee
an accounting of ORR resources and money being used by Mr. Lloyd in his
personal interventions?
Again, can you put aside personal ideology and follow the law?
Answer. If confirmed as HHS Secretary, I will ensure that the
Office of Refugee Resettlement is run in accordance with the Refugee
Act, the Homeland Security Act, and the Trafficking Victims Protection
Reauthorization Act of 2008, as well as other applicable Federal
statutes and regulations.
Question. In your response to Senator Cardin's question regarding
the Mexico City Policy, you stated that you were ``not deeply
familiar'' with the implementation of the global gag rule during this
administration as compared to previous ones. Under the previous
iteration of the policy, roughly $600 million in global health
assistance was at risk of being taken away. Now, under President
Trump's version of the policy, nearly $9 billion in U.S. foreign aid is
in danger of being denied to those in need for ideological and
unscientific reasons. Do you believe that this policy best serves the
interests of the United States to deny millions of people around the
world access to health assistance?
Where do you believe there is room for you, as Secretary, to make
an impact on our global health policy and ensure that these people
receive the basic care that they need?
Answer. If confirmed, I will consult with the leadership of CDC and
other HHS components who are implementing the expansion of the Mexico
City Policy to all global health assistance and learn from them how it
has been received by HHS's non-governmental global health grantees,
including any challenges that may have arisen from the policy. I do not
believe that President Trump's decision to modernize the Mexico City
Policy to reflect the way family planning and global health assistance
are integrated in our current foreign assistance structure, to the
extent allowed by law, affects funding levels in any way, and that no
patient loses access to critical HIV/AIDS services as a result.
If confirmed, I will continue the Trump administration's support
for the Global Health Security Agenda because the American people are
better protected from global health threats when other countries are
able to detect, contain, and respond to them before they spread across
international borders
Question. Of the funding put at risk by this new Global Gag Rule,
roughly $6 billion is marked for HIV/AIDS programs across the globe,
under the President's Emergency Plan for AIDS Relief (PEPFAR). This
threatens the incredible progress that the global HIV community has
made in combatting the epidemic over the past 15 years. What are your
plans to ensure that all of the increases we have made in this fight
will not be diminished?
Answer. I believe that the PEPFAR Program launched by President
George W. Bush is one of the United States' most significant
contributions to the public health of the American people and the
world. The evidence of its success can be seen in the enormous numbers
of lives saved by antiretroviral drugs and the prevention of new
infections. I do not believe that President Trump's decision to
modernize the Mexico City Policy to reflect the way family planning and
global health assistance are integrated in our current foreign
assistance structure, to the extent allowed by law, poses a risk to the
PEPFAR program. The policy is designed such that funding levels are not
affected in any way, and that no patient loses access to critical HIV/
AIDS services as a result. The policy includes reviewing implementation
to ensure that these goals are met. If confirmed, I will work to
implement the policy toward these goals as well, and to support PEPFAR
and the Global Health Security Agenda so that the United States and the
world are better able to prevent, detect, contain, and respond to the
next big global health threat.
Question. As Secretary, what are your specific goals for HHS in
combatting HIV/AIDS around the world and in the United States?
Answer. If confirmed, I am committed to ensuring HHS remains a
world leader in HIV/AIDS prevention and treatment strategies and
research. I look forward to reviewing both the National HIV/AIDS
Strategy, as well as the National Viral Hepatitis Action Plan, and
working with stakeholders to reduce new infections and improve access
to care and treatment outcomes.
Question. A 2011 study by Stanford University found that the global
impact of the Mexico City Policy led to increased abortions in African
countries where U.S. global public health funding was cut the most.
This was an unintended consequence of the lack of available family
planning and contraceptive services that resulted from the cuts. Do you
believe that the implementation of President Trump's Mexico City Policy
will lead to fewer abortions in low-income countries around the world?
Answer. If confirmed, I will consult with the leadership of CDC and
other HHS components who are implementing the expansion of the Mexico
City Policy to all global health assistance and learn from them how it
has been received by HHS's non-governmental global health grantees,
including any challenges that may have arisen from the policy.
______
Question Submitted by Hon. Robert Menendez
and Hon. Bill Nelson
Question. In a December 22, 2017 letter we led with a bipartisan
group of Senators, we asked CMS Administrator Verma to exercise her
regulatory authority to address the immediate health-care needs of
those residing in Puerto Rico. One item we emphasized in our letter was
the importance of CMS recalculating Puerto Rico's Medicare
Disproportionate Share Hospital (DSH) payments to account for the fact
that DSH payments are based, in part, on the number of Medicare
patients who are entitled to Supplemental Security Income (SSI)
benefits and residents of Puerto Rico are ineligible for SSI. Will you
work with our offices and the other offices on the letter to address
the health needs of our fellow U.S. citizens in Puerto Rico?
In general, Medicare payments to Puerto Rico hospitals have
historically been significantly lower than payments to hospitals in the
States. This is particularly the case for Medicare Disproportional
Share Hospital (DSH) payments. In light of the extreme hardship facing
Puerto Rico hospitals at this time, would you be willing to revisit and
reconsider the inclusion of low-income Puerto Rico Medicare
beneficiaries when calculating Medicare DSH payments for Puerto Rico
hospitals?
Answer. I am certainly aware of the unique challenges that Puerto
Rico has faced even before the hurricane. Of course, these challenges
are compounded following such a serious storm. If confirmed, I look
forward to learning more about this issue, and working with Congress
and CMS to address issues faced by Puerto Rico.
______
Questions Submitted by Hon. Thomas R. Carper
Question. In Medicare, Medicaid, and the private sector, health-
care delivery and payment systems are seeing 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. If confirmed, will you ensure
that CMS updates these regulations quickly to provide more flexibility
to PACE so that our medically frail seniors can have greater access to
its gold-standard, proven and replicable model of integrated,
community-based, and person-centered care?
Answer. It is my understanding that CMS is reviewing their existing
regulations and taking steps to evaluate and streamline regulations
with a goal to reduce unnecessary burden, increase efficiencies, and
improve the beneficiary experience through their Patients over
Paperwork initiative. If confirmed, I will work with CMS to make sure
their programs achieve a balance between protecting patient safety and
avoiding undue burden on providers. In addition, I look forward to
hearing ideas from Congress and other stakeholders on how CMS can
improve their programs to make sure beneficiaries have access to high-
quality care that meets their needs.
Question. An important change in the proposed rule on PACE issued
last August would explicitly allow physician assistants (PA) to be
employees or contracted providers. While PAs currently manage patient
panels across the Nation and provide high quality medical care to both
Medicare and Medicaid beneficiaries with chronic care management,
current rules exclude PAs from being an employee or contracted provider
in the PACE program. If confirmed, will you continue work to strengthen
the PACE program and ensure it is modernized in a way that effectively
utilizes the PA profession?
Answer. I agree that Physician Assistants are a vital part of our
health-care system. If confirmed, I look forward to reviewing the
changes outlined in the proposed rule, and I will work with CMS to make
sure we effectively utilize health-care professionals across its
programs.
If confirmed, I also look forward to working with CMS, Congress,
and other stakeholders to make sure beneficiaries with chronic
conditions have access to high-
quality care that meets their unique needs.
Question. Health information technology (health IT) is a rapidly
developing field that is improving coordination and quality of care for
millions of patients across the Nation, but also brings many challenges
related to interoperability, security, data analysis and availability,
and reporting requirements. As Secretary, you would oversee a
Department that is not only responsible for modernizing our health IT
infrastructure, via implementation of the 21st Century Cares Act, but
also is a major public payor, and therefore can influence how other
health-care stakeholders adopt next-generation health IT. In your view,
how can the Department help accelerate interoperability in health IT,
and improve the availability of specific data related to the Medicare
program, which can help risk-based coordinated care providers, such as
accountable care organizations, tailor their services to the specific
needs of their patients and providers?
Answer. I agree that interoperable health information technology is
one of the key enablers for improving cost, quality, and value in our
health-care system. I believe that all individuals, their families, and
their health-care providers should have appropriate access to
electronic health information that facilitates informed decision-
making; supports coordinated health care and case management; allows
individuals and caregivers to be active partners and participants in
their health care; and improves the overall health of the Nation. I
also recognize that, as health information flows more freely through
interoperable health IT to achieve these important goals, people need
confidence that their health information is secure. I will be committed
to working with HHS staff on both interoperability and information
security, if confirmed as Secretary.
Question. You served at the Department of Health and Human Services
during the initial implementation of the Medicare Part D program. That
program has been successful ensuring that seniors have coverage for the
medications that their doctors prescribe. In addition to covering to
cost of drugs for seniors, the Part D law also included medication
therapy management services to help seniors take their medications
correctly and to obtain the greatest health-care benefit.
Unfortunately, that part of the program has not been as successful as
we had hoped. A recent report by the Medicare Payment Advisory
Commission indicated that the medication therapy management programs
are ``falling short'' of their goal to reduce unnecessary expenditures
and improve quality. The report also indicated that physicians might be
reluctant to accept recommendations on medication management from Part
D drug plans.
Given that MTM in the Part D program isn't meeting its intended
goals, what more should we do to help seniors use their medications
effectively? Do you think we should do more to make sure proven
medication adherence programs such as comprehensive medication
management and medication synchronization are available to seniors in
Medicare? How can we make sure that doctors and clinical pharmacists
are collaborating to help Medicare beneficiaries take the right drugs
in the right ways at the right times?
Answer. As I indicated my opening statement, one of my top four
priorities as Secretary, if confirmed, will be to use the power of
Medicare to drive transformation of our health-care system from a
procedure-based system that pays for sickness to a value-based system
that pays for quality and outcomes. The Center for Medicare and
Medicaid Innovation will be a critical part of these efforts.
I understand that CMMI currently has an ongoing model, the Part D
Enhanced MTM Model, which offers an opportunity and financial
incentives for basic stand-alone Part D Prescription Drug Plans (PDPs)
in selected regions to offer innovative MTM programs in lieu of the
standard CMS MTM model, aimed at improving the quality of care while
also reducing costs. I believe CMS is also testing changes to the Part
D program that aim to achieve better alignment of PDP sponsor and
government financial interests, while also creating incentives for
robust investment and innovation in MTM targeting and interventions. If
confirmed, I look forward to coordinating with CMS as they work toward
their goal of fostering an affordable, accessible health-care system
that puts patients first.
Question. Secretary Sylvia Burwell laid out an ambitious goal to
move our country's health-care system from a fee-for-service system
that can result in waste and inefficiency to a value-based system to
keep Americans as healthy as possible. Unfortunately, your predecessor
took us in the wrong direction by dismantling Medicare programs that
would reward health-care providers based on outcomes instead of the
number of procedures performed.
How will you ensure that Medicare and Medicaid work together with
our private health insurance system to increase efficiency, lower
health-care costs, and improve health outcomes?
Answer. One of my top four priorities as Secretary, if confirmed,
will be to use the power of Medicare and Medicaid to drive
transformation of our health-care system from a procedure-based system
that pays for sickness to a value-based system that pays for quality
and outcomes. If we start from the principle of empowering patients and
putting their needs first, we can reform our health insurance system to
realize efficiencies, reduce health-care spending and improve patient
care. If confirmed, I will strive to work with staff across HHS to make
health care more affordable, more available, and more tailored to what
individuals need in their care. I look forward to working with Congress
and the staff at HHS to identify and execute reforms that will put
patients and beneficiaries first and drive towards the value-based
system you referenced and that we all desire.
Question. In the 2017 open enrollment period, almost 9 million
Americans enrolled in health insurance plans through HealthCare.gov,
demonstrating a clear need and interest in affordable health insurance
plans as provided for under the Affordable Care Act.
How will you use the 1332 waiver program to provide States with
additional flexibility to carry out the Affordable Care Act? How will
you ensure that Americans will not lose their health insurance and that
there is order and stability in the individual health insurance
marketplace?
Answer. I would intend to use the 1332 waiver program to help
States make insurance more affordable, available, and tailored to the
needs of the individual. Our shared goal is to expand access to
affordable insurance to as many Americans as possible and to ensure
that this insurance is real insurance with access to real providers and
that it meets their needs. State-driven innovation must be a top
priority for the Department. I support continued efforts to use CMS's
waiver authorities to test and evaluate demonstrations that can lower
health-care costs or improve quality. These need to be approached
carefully to avoid the potential for waste, fraud, and abuse, but an
unwillingness to examine these areas makes us penny-wise and pound-
foolish too often. If confirmed, I will work closely with CMS to ensure
the continued support and the timely review of all State 1332 waivers
received by HHS, and to make the waiver approval process more
transparent, efficient, and less burdensome.
Question. Obesity, smoking, and social isolation are among our
country's most persistent public health challenges, driving up
mortality rates and resulting in more than half a trillion in health-
care costs each year.
As the head of the Health and Human Services Department, how would
you lower the rates of obesity, smoking and tobacco use, mental health
illness, and substance abuse?
Answer. These are all complex public health issues that deserve our
attention. I believe we must implement evidence-based programs and
policies that are proven to make an impact in these areas. If
confirmed, I look forward to working with the experts at CDC, NIH, FDA,
and other agencies to learn about the work currently underway to
address these public health issues. I commit to ensuring that we are
leveraging our resources to the greatest extent possible to make
advances in these areas.
______
Questions Submitted by Hon. Benjamin L. Cardin
kidney care
Question. Stabilizing the Medicare ESRD Payment Program. While the
number of Americans living with kidney failure is relatively small when
compared with other chronic diseases, the Federal Government has made a
big commitment to ensuring that these patients have access to the
highest quality care. Currently, patients have a choice as to whether
to maintain private insurance at the onset of their disease for a
period of time or enroll into Medicare immediately. This choice is
important and should be preserved, but it also demonstrates that the
Federal Medicare program is critically important to these patients who
require 3-4 dialysis sessions per week to manage their chronic
condition. These sessions may occur in dialysis facilities or in the
home. The current Medicare payment system, however, does not cover the
cost of providing these services. Since the inception of the program
there have been concerns about dollars being removed from the program
because of a flawed methodology for calculating the rate. I have called
on CMS to fix this problem in my legislation, the Chronic Kidney
Disease Improvement in Research and Treatment Act (S. 1890) as well.
Can you describe how CMS will fix this problem to work to ensure that
the rates are set in a manner to ensure adequate payment and protect
access to these life-sustaining services?
Answer. I share your concern for patients suffering from ESRD, and,
if confirmed, look forward to working with you in this area. My
understanding is that, by statute, dialysis facilities are paid a
single bundled payment for each dialysis treatment that will cover all
renal dialysis services and home dialysis furnished to Medicare
beneficiaries with ESRD. The bundled payment includes all renal
dialysis services furnished for outpatient maintenance dialysis,
including drugs and biologicals (with the exception of oral-only ESRD
drugs until 2025) and other renal dialysis items and services that were
formerly separately payable under the previous payment methodologies.
The bundled payment rate is case-mix adjusted for a number of factors
relating to patient characteristics. There are also facility-level
adjustments for ESRD facilities that have a low patient volume, for
facilities in rural areas, and for wage index. For high-cost patients,
an ESRD facility may be eligible for outlier payments. In addition,
facility payments for dialysis services are linked to how well the
facility performs under the ESRD Quality Incentive Program (QIP). Under
the ESRD QIP, payments to facilities under the ESRD PPS are reduced by
up to 2 percent if facilities do not meet or exceed a minimum total
performance score with respect to performance standards established by
the Secretary with respect to certain quality measures for a given
year. I believe significant changes to the payment structure of the
program would require congressional action. If confirmed as Secretary,
I will work with you, with CMS, and with stakeholders to ensure we are
doing everything we can as a Department and an agency to ensure CMS
reimbursement policies are structured in a way to maximize the quality
of care provided to these particularly vulnerable beneficiaries.
emergency health services
Question. I led the effort in Congress in the mid- to late-90s to
ensure Medicare and Medicaid provided coverage for emergency services
without prior authorization and established a Federal ``prudent
layperson standard.'' This standard defines an ``emergency medical
condition'' as one that manifests itself by acute symptoms of
sufficient severity (including severe pain) such that a prudent
layperson, who possess an average knowledge of health and medicine
could reasonably expect the absence of immediate medical attention to
result in placing the health of the individual in serious jeopardy,
serious bodily functions, or serious dysfunction of any bodily organ or
part. This important patient protection was extended to all Federal
health plans by executive order in 1998 and through congressional
action to ERISA [group and individual market] plans in 2010. Do you
support this Federal policy?
Would you agree that we don't want patients trying to self-
diagnose?
Will you ensure the Department of Health and Human Services
continues to enforce the prudent layperson standard?
Answer. It is my understanding that the law requires that if group
health plans and health insurance issuers cover any benefits with
respect to services in the emergency department of a hospital that the
plan or issuer must provide those benefits without the need for any
prior authorization determination, even if the emergency services are
provided on an out-of-network basis. If confirmed, I will commit to
continuing to implement and enforce the laws within the purview of the
Department of Health and Human Services.
dental coverage
Question. Each year American children, nursing home residents, and
other adults die because of dental infections. OHA cites the case of
12-year-old Deamonte Driver of Maryland, who died of complications
resulting from untreated tooth decay in 2007. If confirmed, what steps
will you take to ensure all Americans, young and old, poor or rich,
educated or non-educated, receive dental insurance to cover dental
services such as exam, cleanings, fillings, and extractions?
Answer. The serious health risks and costs associated with
untreated oral disease are increasingly apparent. Not only can poor
oral health lead to serious pain and impact the types of foods seniors
need to eat to stay healthy, tooth decay may exacerbate diabetes,
arthritis, and heart disease. Additionally, dental disease may
preclude, delay, or even jeopardize the outcome of medical treatments
such as organ and stem cell transplantation, heart valve repair or
replacement, cancer chemotherapies, and placement of orthopedic
prostheses.
Many oral health complications, such as tooth decay, are largely
preventable. Yet, tooth decay continues to be one of the most common
chronic conditions among children, with the propensity to significantly
impact a child's quality of life by causing pain and interfering with a
child's ability to speak and learn. As such, it is critical that we
protect children's access to high-quality pediatric dental care.
If confirmed, I would work with CMS, IHS, and other parts of the
Department to ensure every single American has access to the coverage
they want for themselves or their children and dependents. In addition,
I would aim to provide States with flexibility in their Medicaid
programs to provide both coverage and access to these services. I would
also welcome ideas from Congress and other stakeholders regarding
opportunities to encourage innovation in both the coverage and payment
for these services.
______
Questions Submitted by Hon. Benjamin L. Cardin
and Hon. Debbie Stabenow
Question. Under the Patient Protection and Affordable Care Act,
dental coverage for children is categorized as an ``essential health
benefit.'' As a result, oral health is viewed as an integral part of
overall health and 8 million children are guaranteed a dental benefit.
What is your position on preserving pediatric dental as an essential
health benefit?
Answer. It is important that every child has access to high-quality
health coverage and that we make health care more affordable, more
available, and more tailored to what individuals want and need in their
care. Access to oral health care for children is indeed an integral
part of that, as tooth decay continues to be one of the most common
chronic conditions among children.
If confirmed, I will commit to continuing to implement and enforce
the laws within the purview of the Department of Health and Human
Services.
Question. The Children's Health Insurance Program (CHIP) is a
successful bipartisan-supported Federal program that provides dental
coverage to children. Coverage under CHIP includes: dental visits,
cleanings, fluoride, sealants, and fillings. The Senate Finance
Committee passed S. 1827, the Keep Kids' Insurance Dependable and
Secure (KIDS) Act of 2017 with bipartisan support. The Congressional
Budget Office (CBO) and the Joint Committee on Taxation (JCT) recently
completed a preliminary estimate of the budgetary effects of extending
funding for CHIP for 10 years using the parameters set out by the KIDS
Act. The agencies estimate that enacting such legislation would
decrease the deficit by $6 billion over 10 years. Do you support a
long-term extension of funding for CHIP that provides 9 million
children and 370,000 pregnant women with affordable, age-appropriate
health coverage, including a guaranteed dental benefit?
Answer. As I said above, it is important that every child has
access to high-
quality health coverage. CHIP plays an important role in accomplishing
this objective. HHS should work with Congress and with States to ensure
that the CHIP program provides the best possible coverage to children
in each State.
Question. Over 55 million Americans rely on receiving health-care
coverage through Medicare. In his announcement to run for President,
President-elect Trump promised to ``Save Medicare, Medicaid, and Social
Security without cuts'' and continued to make this promise throughout
his campaign. Do you agree with President-elect Trump's statements, and
what is your vision for the future of Medicare? Specifically, what
changes do you believe are needed in Medicare and does your vision
include the addition of an oral health benefit to improve the overall
health of seniors?
Answer. Oral health is an important aspect of general health and
well-being. My understanding is that Medicare pays for dental services
that are an integral part either of a covered procedure (e.g.,
reconstruction of the jaw following accidental injury) or for
extractions done in preparation for radiation treatment for neoplastic
diseases involving the jaw. Additionally, many seniors in Medicare
Advantage plans receive additional dental benefits, depending on the
structure of their plans. If confirmed, I will faithfully implement the
law to ensure that Medicare covers medically necessary oral health
care.
I think one of the best ways to drive down costs without harming
beneficiary access to care is to improve how we operate Medicare using
a more value-driven approach. We need to make sure Medicare can serve
future generations, and if confirmed, I will work with CMS, Congress,
and other stakeholders to make sure we come up with the right
approaches to work towards this goal.
cms vacancy for chief dental officer
Question. The Chief Dental Officer vacancy at the U.S. Centers for
Medicare and Medicaid Services (CMS) is of significant concern to the
oral health community because the chief dental officer is charged with
providing oral health expertise and support for Medicaid and the
Children's Health Insurance Program (CHIP). Ensuring that children who
are eligible for Medicaid and CHIP have access to appropriate,
comprehensive, and preventative dental care is vital to achieving
healthy communities. Will you make it one of your top priorities to
fill the vacant chief dental officer position at CMS?
Answer. I share your interest in bolstering access to dental care
for all Americans, in particular children. If confirmed, I look forward
to reviewing the staffing needs of CMS and maximizing the Department's
resources to fulfill our mission.
global health
Question. The United States is one of over 50 countries that have
committed to the Global Health Security Agenda, which aims to help
countries improve their capacity to prevent, detect, and respond to
infectious disease outbreaks. As Secretary, what specific actions will
you take to advance the Global Health Security Agenda?
Answer. I am very supportive of U.S. participation in the Global
Health Security Agenda and believe this global work is critical to
protecting the Nation's public health. I believe it is important to
continue to build support for the GHSA by encouraging the participation
of more countries and ensuring that existing members of the partnership
are undergoing transparency and evaluation efforts pursuant to the
framework to which we all agreed. If confirmed, I will work with
leaders on this issue both at HHS and at other Departments and agencies
to build upon the achievements to date.
Question. What role do you see for HSS in supporting and enhancing
global efforts to detect, prevent, and respond to diseases
internationally to prevent them from becoming a threat to the United
States? How do you plan to coordinate these efforts with the efforts
being undertaken at the Agency for International development to build
capacity in developing countries along these lines?
Answer. Global health surveillance is critical to protecting the
health of our citizens. With the expansion of international travel for
instance, diseases can spread quickly between countries, including the
United States. This fact requires all countries to take steps to
provide adequate surveillance and put in place measures to stop the
spread of these diseases. If confirmed, I look forward to working with
HHS's Office of Global Affairs and CDC, as well as with our partners at
the Agency for International Development, to ensure that we are doing
all we can to work with other countries to stop the spread of diseases
internationally. This is a major goal of the President's Global Health
Security Agenda.
Question. In your view, are we and our partners in the developing
world any better off today in our ability to respond to another crisis,
such as Ebola or Zika? If not, what steps are necessary to improve our
readiness to respond to the next global health crisis?
Answer. I was not at HHS during the Ebola and Zika outbreaks, so I
cannot speak specifically to the lessons learned during these crises.
However, from my prior experience at HHS, I know that agency staff make
it a practice to conduct a post-incident review--a ``hotwash''--to
review what happened and identify and act upon the valuable lessons
learned from the incident and our response, so that we can better
address the next crisis. We always have more to learn, and it is
important to conduct a complete evaluation of any response so that we
can build on our successes and address any shortfalls. If confirmed, I
commit to working with individuals within HHS, including staff at CDC
and ASPR, to understand what steps we need to take to improve our
readiness to prevent, detect, and respond to the next potential global
health crisis.
Question. The African Union and the United States signed a
memorandum of cooperation in April of 2015 formalizing a collaboration
between the African Union Commission and the Centers for Disease
Control and Prevention in creating the Africa Centers for Disease
Control and Prevention. The African CDC, headquartered in Addis Ababa,
was officially launched in January 2017. What is your assessment of the
capacity of the African CDC to undertake its mandate, which includes
helping African countries to improve surveillance, emergency response,
and prevention of infectious diseases, and build capacity to reduce
disease burden on the continent?
Answer. I have not had the chance to review or assess the African
CDC. However, as I mentioned above, I do believe it is critical to
encourage the public health efforts of our global partners. If
confirmed, I look forward to learning about efforts underway in Africa
and ways in which our CDC can support the efforts of others around the
world to increase their capacity to prevent, detect, and respond to
public health threats.
Question. What actions do you believe the United States should take
to help support the sustainability of the African CDC?
Answer. I have not had the opportunity to review the African CDC.
However, I look forward to learning about it and taking steps to
encourage the success of its work.
Question. U.S. global health and global health security assistance
programs are vital for stopping outbreaks at the source, and U.S.
leadership has been instrumental in catalyzing new funding from the
private sector and other countries for countering biological threats.
With the loss of Ebola supplemental funding for global health security
in FY 2019, how will you support and ensure that CDC, and its deployed
health security experts who are integral to our Nation's biodefense,
remain well-equipped to extinguish outbreaks when they arise outside of
the United States?
Answer. If confirmed, I look forward to assessing the current
funding available and ensuring we are using the funds optimally in
support of our Nation's biodefense. It is important to ensure that CDC
is well-situated to provide surveillance of and support in
extinguishing disease outbreaks. It is equally important that we
encourage the efforts of our global partners to identify and manage
these outbreaks as well.
Question. Will you protect and strengthen the existing CDC offices
overseas experts, which are so important for stopping outbreaks at the
source?
Answer. I believe it is important to have CDC officials overseas,
and I look forward to learning more about where they are currently
placed and ensuring our resources are used in the most optimal way.
That said, I agree that the best security for the United States is when
other countries are able to be strong partners in the Global Health
Security Agenda, meeting the objectives of that partnership and
building prevention, surveillance and response capacity. CDC is a key
player in helping partner nations build that capacity.
Question. What actions will you take to maintain and build on
existing U.S.-led efforts under the Global Health Security Agenda to
identify gaps and leverage resources from the private sector and other
countries?
Answer. I believe it is important to continue to build support for
the GHSA here at home while also encouraging the participation of more
countries. If confirmed, I look forward to learning more about the work
HHS has already undertaken to promote global health security in the
years since I led these efforts while at HHS. I am very supportive of
efforts to engage the private sector in the important work of
maintaining global health security and, if confirmed, look forward to
partnering with other stakeholders.
Question. Reducing the threat of pandemics--whether naturally
occurring, deliberately caused, or accidentally released--is inherently
a cross-governmental function and a global security priority. How will
you work with your counterparts, including within the Departments of
State and Defense, to ensure close coordination and to continue to
promote biosecurity as an integral component of the Global Health
Security Agenda?
Answer. Collaboration internally and externally with other
government agencies is critical to advancing global health security. I
have experience working interdepartmentally, and I look forward to
working closely with the Departments of State and Defense on these
issues, if confirmed.
Question. What actions will you take to continue to promote the
participation of national security officials within global health
security-related activities sponsored by the U.S. Government?
Answer. As mentioned above, I believe it is critically important
that all Federal partners are involved in global health security-
related activities and believe that global health security issues can
often become national security issues. If confirmed, I would work
ensure that I have strong relationships with my counterparts at other
Federal departments and agencies and will encourage HHS staff to do the
same in an effort to secure participation from all necessary
individuals as we advance global health security.
______
Questions Submitted by Hon. Sherrod Brown
medicaid, work requirements, and the definition of ``able-bodied
adult''
Question. During your hearing, I asked you about what attributes
define an ``able-bodied adult.'' You responded that you haven't used
this term and that it isn't something you don't have a definition for.
Since that time, the Trump administration has released guidance to
States on implementing work requirements within the Medicaid program--a
proposal that is in direct contradiction to the objectives of the
Medicaid program.
Do you agree with the administration's proposal to encourage and
allow States to implement work requirements?
Answer. Yes, I believe that there is significant evidence that one
of the best ways to improve the long-term health of low-income
Americans is to empower them with skills and employment, for those who
are able to work. I also believe that as States propose and experiment
with solutions to encourage independence and work in their communities,
we should ensure that program requirements are measured and conditioned
on the particular individuals and their unique life situations. The
goal is to lift people up out of dependency, and we can and should do
this by applying common sense principles to improve people's lives. We
still have a great deal to learn about how to best assist individuals
seeking to move out of poverty. These waivers would empower States to
adapt their Medicaid programs to the needs of their populations, and
will provide valuable information to the rest of the country. If
confirmed, I look forward to working with States to give them
additional flexibility, while holding them accountable to ensure
patient access to high quality health care.
Question. For the record, please define your interpretation of the
phrase ``able-
bodied adult,'' as utilized by CMS in its recent guidance, to be used
for differentiating between Medicaid recipients.
How would you define ``able-bodied adult''?
Do you believe that an individual who has been diagnosed with
cancer is, in your words, ``able-bodied''?
Do you believe that an individual who has been diagnosed with
severe mental illness is, in your words, ``able-bodied''?
Do you believe an individual with a substance use disorder, such as
opioid dependency, is ``able-bodied''?
Do you believe an individual with an intellectual or developmental
disability is ``able-bodied''?
Do you believe a child aging out of the foster care system is
``able-bodied'' and should be required to work to continue to receive
health-care benefits?
Answer. As I understand the CMS proposal, the agency has outlined a
number of guardrails to ensure that the disabled and medically frail
are not subject to work requirements. Importantly, States will still
also need to abide by the Americans with Disabilities Act (ADA) and
other civil rights laws. If confirmed, I look forward to ensuring that
the work requirements and their associated guardrails are implemented
with the goal of lifting people up and out of dependency and providing
strong protections for those who are unable to work since these are
important goals of this administration and the Medicaid program.
Question. Ms. Verma claims that this proposal is the Trump
administration's way of responding to requests from Medicaid officials
in several States that have expressed an interest in running
demonstration projects to test work requirements. However, it was Ms.
Verma who solicited applications from States to test work requirements
in the first place (in an earlier guidance document). Do you think that
this is an appropriate approach to changing a fundamental entitlement
program?
Do you agree with Ms. Verma's assertion that work requirements are
consistent with the goals of Medicaid, despite the Medicaid statute
including no such element?
According to a recent analysis done by the Kaiser Family
Foundation, approximately 60 percent of non-elderly Medicaid
beneficiaries already work. Of those who are not employed, more than a
third have a disability or illness, another third cares for young
children, and approximately 15 percent are still in school. If
confirmed as Secretary of HHS, will you support the continuation of
this policy?
Answer. Medicaid is a single program dealing with many completely
different population subgroups, including for the first time under the
expansion, able-bodied adults without children. We need to customize
our programs and benefits to the characteristics of our beneficiaries.
While I have not been involved as a nominee in CMS's efforts to allow
States to implement work requirements in their Medicaid programs, I do
believe there is significant evidence that one of the best ways to
improve the long-term health of low-income Americans is to empower them
with skills and employment, for those who are able to work. As I said
above, I also believe that as States propose and experiment with
solutions to encourage independence and work in their communities, we
should ensure that program requirements are measured and conditioned on
the particular individuals and their unique life situations. The goal
is to lift able-bodied adults up out of dependency and we can and
should do this by applying common sense principles to improve people's
lives. If confirmed, I look forward to working with States to give them
additional flexibility, while holding them accountable to ensure
patient access to high quality health care.
opioid epidemic and foster care
Question. Because of the addiction epidemic, many parents are
unable to care for their children due to opioid use, long periods spent
in treatment facilities, and the frequent drug relapses that are a part
of this disease cycle. As a result, over the past 4 years, Ohio has
experienced a 23 percent increase in the number of children served by
the foster care system, and this number is expected to increase another
33 percent by 2020.
And it's not just the foster care system that's overburdened.
Ohio's grandparents are also stressed--according to an article
published in The Columbus Dispatch this past weekend, more than 100,000
grandparents are raising their grandchildren in Ohio--many because of
the opioid epidemic. Ohio's child protection agencies are overwhelmed,
families and grandparents are overwhelmed, and our children are
suffering.
Given the way in which the Federal Government funds foster care, if
confirmed as Secretary of HHS, what specific ways would you use your
authority to address the drastic increase in the number of children
that need foster care, kinship care, and child welfare services, and
prioritize keeping families together wherever possible?
What, if anything, will you do to change how current Federal
programs and inter-agency efforts to address the foster care crisis
work together to prioritize the needs of children, families, and
communities?
How would you support grandparents and other relatives who have
stepped-up to care for these children?
Answer. With the opioid crisis, supporting grandparents and
relatives who act as primary caretakers in their families is an
emergent need and one that the Substance Abuse and Mental Health
Services Administration (SAMHSA) is committed to addressing in its
programs and policy initiatives. If confirmed, I will encourage SAMHSA
to collaborate with the Administration for Community Living to ensure
complementary efforts. However, older adults raising children and youth
have concerns that affect all areas of their family lives: education,
transportation, primary health care, behavioral health care, financial
stability, and for some, juvenile justice. Working together with our
Federal partners, including the Department of Education, the Department
of Justice, and the Department of Housing and Urban Development, we can
help ensure that any programs and policy initiatives address the full
range of needs grandparents and other caregiving relatives may have.
Close coordination will ensure all efforts leverage the full range of
resources across the Federal Government in ways that are non-
duplicative and financially efficient.
medication assisted treatment
Question. During his tenure at HHS, Secretary Price said some
concerning things about medication-assisted treatment (MAT), calling
into doubt the science behind this type of treatment for substance use
disorders. Beyond this specific example, many of us have found the
Trump administration's general approach to scientific findings and
scientific consensus concerning.
Mr. Azar, when evaluating the relative effectiveness of different
programs and treatments, will you rely on scientific, evidence-based
findings?
Answer. If confirmed, I commit to ensuring that HHS's work is based
on scientific, evidence-based findings. That includes MAT, which is the
gold standard in opioid addiction treatment.
Question. As you know, MAT is the use of medications (such as
buprenorphine) in combination with behavioral therapy as a way of
treating substance use disorders. A substantial body of literature
supports the efficacy of MAT, and several of us on this committee--
including my Ohio colleague Senator Portman--have worked together to
increase access to MAT services as part of last Congress's CARA law.
Do you agree that, as part of a comprehensive strategy to address
this epidemic, the government should do more to increase access to both
the overdose reversal drug naloxone as well as products used for MAT
services?
Given the data demonstrating that increased access to MAT leads to
better outcomes for those individuals seeking treatment for a substance
use disorder, Senator Markey, Senator Portman, and a number of other
members worked hard to get a provision included in the CARA law that
would allow certified physician assistants and nurse practitioners to
obtain a waiver to prescribe buprenorphine to help treat opioid
addiction.
Do you support HHS implementing this provision and, if confirmed,
would you work to ensure implementation of this provision in a way that
fully utilizes all eligible advanced providers, including as PAs and
NPs, in providing MAT services?
If confirmed, what other specific actions would you take to expand
access to naloxone and MAT?
Answer. I am supportive of expanding access to medication-assisted
treatment (MAT). It is a critical piece of the strategy to address the
opioid crisis, and HHS has recognized it as such. If confirmed, I look
forward to working to ensure that MAT is available to those with
substance use disorder.
the cost of addiction treatment
Question. As you have acknowledged in prior testimony, government-
granted patent monopolies allow pharmaceutical companies to price-gouge
consumers by taking a decades-old product and jacking the prices up
year after year. It happened with the EpiPen and it happened under your
leadership at Eli Lilly, when you spiked the price of insulin. I have a
bill--the Stop Price Gouging Act--that would prevent this sort of
abusive practice by holding drug companies accountable for large price
increases.
Pharmaceutical companies are also using this tactic when it comes
to medications that can help individuals struggling with addiction.
Take naloxone for example. Even though naloxone is a generic medicine
that was first patented in 1961, the price for a pack of two auto-
injectors in the United States more than doubled between 2015 and 2017,
and now costs more than $4,000.
By all accounts, this should be a cheap and accessible drug--there
are multiple generics on the market. Yet consumers continue to get
price gouged, and pharmaceutical company greed has made this drug
unaffordable, particularly for those who need it most. President
Trump's Commission on Combating Drug Addiction and the Opioid Crisis
has even recognized price as a barrier to naloxone access.
The price of a popular medication-assisted treatment therapy,
buprenorphine, is no better. According to recent testimony in front of
a House Judiciary Committee subcommittee, ``the pricing of MAT
medications by several pharmaceutical companies obstructs access to
treatment for opioid addiction and overdose in America, and thus
prolongs the scourge of heroin and prescription opioid addiction, and
puts American lives at risk.''
Mr. Azar, in your opening statement, you mention your experience at
HHS during the post 9/11 anthrax attacks and their threat on our
Nation's public health. Your boss at the time--then-HHS Secretary Tommy
Thompson--publicly considered using his authority under a section of
the United States Code, title 28 section 1498, that would have allowed
the government to buy generic versions of an otherwise patented anti-
anthrax drug at a steep discount. Mr. Thompson's threat of invoking
title 28 section 1498 allowed the government to leverage a deal with
the brand name manufacturer and cut the price of the anti-anthrax
medication Cipro in half, saving taxpayer dollars and protecting public
health.
Did you play a role in advising then-Secretary Thompson in
threatening to invoke the authority behind section 1498, which led
directly to cheaper medicines?
As you are aware, title 28 section 1498 is not the only authority
HHS can utilize to force a pharmaceutical company to lower the price of
a drug. The Secretary of HHS also has the power to authorize the
purchase of low-cost generic versions of patented medicines and to
leverage that authority to demand reductions in prices of lifesaving
medicines developed with taxpayer dollars under the Bayh-Dole Act and
so-called ``march-in rights.''
Under the Bayh-Dole Act (35 U.S.C. Sec. 200-212) the U.S.
Government retains specific rights when licensing federally owned
inventions, such as NIH-developed drugs. For example, by statue, the
government can employ march-in rights to license the patent to a third
party when ``the contractor or assignee has not taken, or is not
expected to take within a reasonable time, effective steps to achieve
practical application of the subject invention in such field of use.''
``Practical application'' is defined to include an obligation for
reasonable pricing. Despite having this authority for nearly 40 years,
NIH has never exercised its march-in rights.
Given the public health threat that the opioid epidemic currently
poses, if confirmed, would you consider invoking the authorities given
to the Secretary of HHS under the Bayh-Dole Act or under title 28
section 1498 in order to ensure access to life saving medications--
whether it be naloxone, buprenorphine, or any other drug that remains
out of reach for too many Americans?
Thirty-five U.S.C. Sec. 201(f) defines ``practical application: as
making an invention ``available to the public on reasonable terms.''
What do you consider reasonable terms? Should there be any limits on
pricing for government funded drugs that earn billions of dollars in
sales?
If confirmed, would you exercise the public's rights under the
Bayh-Dole Act to lower the prices of medical technology that is based
on federally owned or licensed patents if the price charged for U.S.
residents is significantly higher than that for other high-income
countries?
Answer. I was involved in the negotiations with Bayer to acquire
ciprofloxacin in the aftermath of 9/11 and during the anthrax attacks.
As I noted in a letter to the editor of the American Lawyer--Alex M.
Azar II, ``Letter to the Editor, The Cipro Dilemma,'' American Lawyer,
January 31, 2002--Bayer was never threatened with the use of section
1498, and it was my view and the view of the Department's attorneys
that section 1498 would not authorize FDA to approve a product in
violation of the market exclusivity provisions of the Hatch-Waxman Act.
Section 1498 is not a regulatory provision that would allow the FDA to
approve a product under the Food, Drug, and Cosmetics Act when that Act
does not so permit. Section 1498 does not authorize the government or
its contractors to engage in patent infringement, but rather provides a
remedy in the event that that were to occur. If, for example, a suit
were filed against a government contractor for infringement and various
conditions were met, the government would step in, defend the suit, and
ultimately pay. Section 1498 has never been used in a situation like
this, does not automatically result in a lower drug price, and it is
not a cost free option.
My understanding is that the Department has reviewed the Bayh-Dole
Act and determined that the Act does not permit march-in on the basis
of market price alone. If confirmed, I look forward to reviewing this
legal analysis.
evergreening
Question. During your testimony in front of the HELP Committee in
November and again in front of the Finance Committee on Tuesday, you
talked a lot about your work during your time at HHS to address
evergreening, where a pharmaceutical company tweaks a tiny part of a
product in order to extend its exclusivity. You claim that your efforts
to limit evergreening resulted in a rule that was estimated to save
consumers $34 billion over 10 years.
During your testimony in front of the HELP Committee back in
November you said, and I quote: ``We have to fight gaming in the system
of patents and exclusivity by drug companies. I have always been an
opponent of abuse and gaming of the patent systems by drug companies.''
In the last few days, however, media reports have emerged that
claim that during your tenure at Eli Lilly, the company was able to
extend its patent on the erectile dysfunction drug Cialis by testing it
for a rare muscle-wasting disease in pediatric patients.
Do you believe that loopholes in current law remain that allow
pharmaceutical companies to engage in ``evergreening'' or ``product
hopping,'' especially in light of the emerging biosimilars market?
How do you respond to these media claims regarding ``gaming'' by
Lilly?
If confirmed, will you commit to working with Congress to identify
those existing loopholes, promulgate regulations designed to close
them, and, if legislative action is necessary, provide the technical
assistance necessary to improve and modernize the law and prevent
future abuses for all types of drugs, including small molecule,
biologic, and combination products?
In addition to targeting evergreening, what specific ideas can you
propose for addressing patent ``gaming''?
Answer. I have made clear my concerns with those companies that
game or ``evergreen'' patents and exclusivities by branded companies
under Hatch-Waxman and other provisions of the Food, Drug, and
Cosmetics Act. If confirmed, I will support the FDA's ongoing efforts
to review its regulatory authorities to identify those abuses which can
be addressed under existing authorities, those which require a
coordinated, cross-government action, and those which require
legislative changes. As we discussed in the hearing, I am particularly
concerned about the issues of (1) branded companies using REMS programs
to prevent the study of the drug and approval of a generic form of the
reference drug subject to REMS, (2) branded companies limiting supplies
of reference product on which to conduct needed studies, and (3)
branded companies securing patented modifications to the underlying
product and withdrawing the previously approved product from the
market, thus making entry of a generic competitor to that earlier
version of the product . In addition, the Food and Drug Administration
Reauthorization Act of 2017 (FDARA), which was signed in to law earlier
this year, clarified that FDA may require a drug be superior to other
drugs on the market in order to receive market exclusivity. I expect
Dr. Gottlieb and FDA will implement these clarifications and look
forward to reviewing whether incentives for innovation are adequately
balanced with timely access to generic competition as intended under
the Hatch-Waxman Act.
Regarding the pediatric exclusivity program, pediatric studies
resulting in exclusivity are only done if FDA sends a ``written
request'' to a company for a pediatric study and the company accepts
that request and performs that study to the FDA's satisfaction.
Definitively knowing what does not work for or in pediatric populations
can be as valuable as knowing what definitively does work. The
pediatric exclusivity incentives have over the years proven to be an
invaluable tool to get companies to spend the tens of millions of
dollars to study medicines in pediatric populations, where they would
otherwise lack the economic justification to do so. With regard to this
particular program and the inaccurate headline in Politico, I do not
believe performing clinical trials at the request of FDA pursuant to a
statute created by Congress to attempt to discover a therapy that might
help children suffering from and dying from Duchenne Muscular Dystrophy
is a game in any respect. That is the pediatric exclusivity statute
working exactly as Congress intended.
drug reimportation
Question. During your hearing in front of the Senate HELP
Committee, Senator Paul asked you to come back with ideas on how to
make the reimportation of drugs from Canada and Europe ``safe.'' Like
Senator Paul, I believe that the safe reimportation of prescription
drugs from countries with rigorous safety standards such as Canada and
Australia represent steps that would significantly reduce drug costs.
As HHS Secretary, would you support drug reimportation? If no, why
not? If yes, what ``safeguards,'' if any, would you propose to put in
place?
Answer. Congress has established a statutory framework which
governs the importation of prescription drugs. Under this framework,
HHS's statutory authority to promulgate regulations implementing an
importation program becomes effective only if the Secretary certifies
to Congress that the implementation of such a program will pose ``no
additional risk'' to the public's health and safety and that it will
result in ``a significant reduction'' in costs for American consumers.
My understanding is that previous Secretaries have been unable to make
this certification based, at least in part, on unacceptable risks to
the public's health and safety that would result from opening the
Nation's drug supply to unapproved drugs from sources that may be
difficult to verify. If confirmed, I will ensure that I am briefed on
the facts informing this assessment of the risk to the public's health
and safety, including current non-public facts to which I do not
currently have access.
One of the challenges to importation safety in the past has been
the inability to connect the U.S. closed distribution system to
Canada's (or another country's) closed distribution system. In
addition, if confirmed, I commit to exploring whether any pilots or
demonstrations might be utilized to see if a system could be set up in
a way such that public health officials would support a determination
of no additional risk to the public's health and safety and of a
significant reduction in costs for American consumers, when
appropriately scaled up to represent the likely level of importation.
patent exclusivity
Question. Under our current system in the United States,
pharmaceutical companies are able to develop a drug and charge as high
a price as possible to the patient during the monopoly period,
resulting in barriers to access and significant financial burdens for
patients.
As HHS Secretary, would you support or encourage research into the
feasibility of new business models to delink the cost of research and
development to the price charged to patients?
In 2012, Robert A. Armitage, who was then Senior Vice President and
General Counsel at Eli Lilly, testified in front of the House Judiciary
Committee that the current system in the United States does not provide
enough patent protection for American pharmaceuticals, advocating for a
``prior user'' defense.
Do you agree with your former employer that the pharmaceutical
industry needs greater patent protections and longer patents for drugs?
Answer. If I am confirmed as Secretary, one of the critical areas I
plan to focus my efforts on is to lower drug prices. I believe through
my experiences in both the public and private sectors I can start
working immediately at the Department of Health and Human Services to
identify solutions to the drug pricing issue. I believe that we need to
institute policies that lower the list prices of drugs while also
maintaining innovative new research and development. I am interested in
novel ideas to lower the price of drugs and look forward to working
with you on this issue, if confirmed.
stop price gouging act
Question. The Stop Price Gouging Act (S. 1369), which I reference
above in question 4, requires drug companies to report increases in
drug prices, and to justify any increase above medical inflation.
Additionally, the legislation penalizes drug companies that engage in
unjustified price increases with financial penalties proportionate to
the price spike.
As HHS Secretary, would you support such penalties for price spikes
as a means to lower prescription drug costs? If no, how would you
propose to change the incentives under the act.
Answer. As I said during my opening statement to the committee,
drug prices are too high. The existing system for pricing and
reimbursement of drugs works for many of the players in the system, but
not for patients who have to pay high out-of-pocket costs for their
drugs because of lack of insurance, high deductibles, or high cost
sharing. Drug pricing is informed by a multitude of factors including
the list price, competitive market dynamics, government rebate
programs, insurer market power, discounts to the list price, global
freeloading by international price-fixing behavior, and research and
development costs, to name a few. If confirmed, I will work to fix this
broken system, and use my knowledge and experience to reduce drug
prices for patients.
biosimilars
Question. You have stated that you are interested in promoting
innovation and fostering competition in drug development. I have
introduced legislation in the past that would help achieve this by
shortening the patent exclusivity period for expensive, brand-name
biologic drugs and allow biosimilars to enter the market sooner.
Biosimilars, which are equivalent in safety and efficacy to their
reference biologics, have the capacity to lower drug prices and reduce
out of pocket costs for patients. In fact, a recent RAND study
projected that a robust biosimilar market could save America's patients
$150 billion over 10 years.
Mr. Azar, can you please describe the importance of biosimilars in
reducing prescription drug costs for patients and the Federal
Government?
How will you, as Secretary of HHS, support the uptake of
biosimilars in the United States?
What do you believe to be the FDA's role and CMS's role in
educating patients, providers, and other stakeholders about
biosimilars?
Can you discuss how inclusion of biosimilars in the Medicare Part D
coverage discount program could reduce costs and cultivate the
biosimilar market for all patients?
Under the Affordable Care Act (ACA), brand drug manufacturers are
required to offer statutory discounts under the Medicare Part D
coverage gap to offset the cost-sharing for beneficiaries who are
required to pay the full price for prescriptions. Biosimilar
manufacturers, however, are exempted from this requirement.
Do you believe the current coverage gap discount program could
discourage the uptake of biosimilars in any way?
Answer. If confirmed, I look forward to working with both FDA's and
CMS's senior leadership to ensure that we have clear regulatory and
coverage policies in place that support patients having access to safe
and effective medical products, including biosimilars, in a timely
manner and that support the development of a competitive market among
biosimilars and with innovator products. An important component of
biosimilar development and integration into the marketplace will be
education for providers and patients. If confirmed, I will work with
FDA's leadership to ensure we are educating clinicians and patients
about biosimilars generally, as well as information specific to any
biosimilar approvals at the time of such approvals.
medicaid and family planning services
Question. Two-thirds of births from unintended pregnancies in the
United States are paid for by Medicaid or the Children's Health
Insurance Program (CHIP). Public funding in my home State of Ohio
supported slightly more unintended pregnancies than the national
average. In 2010, these unintended pregnancies cost a total of $21
billion dollars, including $824 million in Ohio. Publicly funded family
planning allows families to prevent unwanted pregnancies, and it is
estimated that investing in family planning services would have saved
public funding of unintended pregnancies by a total of $15 billion,
including $607 million for Ohio. That's striking--almost 75 percent of
the money spent on unintended pregnancies is estimated to be saved.
Unfortunately, many States are seeking waivers that would allow
them to discriminate against certain family planning providers, leaving
women with far fewer options and denying them their provider of choice.
Some States want to insert work requirements into their waivers. And
you have expressed support for converting Medicaid to block grants. All
of those steps would dramatically limit the resources that are
available for providing health care to the Nation's poorest people and
are likely to harm reproductive and maternal health.
Do you acknowledge the effectiveness of investing in contraception
and the need to continue the Medicaid State option to expand family
planning services?
How will you ensure that family planning services, included access
to preferred contraception methods, will remain available to all women?
Would you support State waivers that attempted to exclude maternity
care? If such waivers were to be granted, resulting in reduced access
to care, how would you plan to ensure that all women receive the health
care they need before, during, and after pregnancy?
Answer. I believe that all women should have access to quality,
affordable health care and insurance coverage that works for them and
that meets their needs. Patients must be empowered to decide what kind
of coverage they need, rather than Congress or HHS mandating what they
must purchase. If confirmed, I will also work with States to help them
achieve their goals with as much flexibility as possible, within the
parameters and confines of the law.
birth control ifrs
Question. In October 2017, the current administration issued two
Interim Final Rules to allow employers, universities, and insurers with
religious or moral objections to contraception to deny their employees
and students insurance coverage for birth control. These rules were
issued as Interim Final Rules, forgoing the normal Notice of Proposed
Rulemaking process. The rules have potential to impact thousands of
women, who could lose the contraception coverage they have come to
depend upon.
Do you agree with the idea that employers or insurance companies
should be able to deny women birth control coverage based on their
religious or moral ``beliefs''?
Do you believe that it was necessary to issue these regulations as
IFRs, instead of going through the normal rulemaking process?
Answer. I believe all women should have access to the care that
they need. We can advance that goal while simultaneously following the
many laws protecting the right of conscience in health care. If
confirmed, I look forward to working with others at HHS as well as
Congress to ensure that both can be achieved.
reproductive rights
Question. In the landmark Roe v. Wade decision that established
abortion as a fundamental right for women, the Supreme Court declared
that ``the word `person,' as used in the Fourteenth Amendment, does not
include the unborn.'' This central holding has been consistently upheld
and reaffirmed by the Supreme Court.
However, HHS's recently released 2018-2022 Draft Strategic Plan
makes references to an American lifespan spanning from ``conception''
to ``natural death,'' and vows to respect ``the inherent dignity of
persons from conception to natural death.''
As HHS Secretary, would you retain this unconstitutional and non-
medical definition in the HHS strategic plan? If yes, how would this
definition alter existing HHS programs and policies, and how will you
ensure women's access to other crucial and legal health care services,
such as abortion, are not threatened by it?
Answer. The mission of HHS is to enhance the health and well-being
of all Americans, and this includes the unborn.
aca individual mandate
Question. As you are aware, Congress recently passed a tax reform
bill that was signed into law by President Trump. In addition to
providing tax cuts for the wealthy under the ruse of ``trickle-down''
economics, the bill repealed an important component of the Affordable
Care Act: the individual mandate.
CBO has predicted that repealing the individual mandate will result
in increased premiums averaging 10 percent each year. In your opinion,
will a 10-percent increase in premiums year after year continue to
destabilize the market and cause additional insurers to exit the
marketplace?
It has been projected that 13 million Americans will lose access to
health insurance due to the prohibitively high cost of premiums as a
result of repealing the individual mandate. How do you propose to limit
these annual increases and keep health care affordable for the millions
of Americans who rely on the individual market as their only source of
health insurance?
Answer. I believe it is important to note that the CBO clearly
stated in November of this past year that it is revising its approach
to evaluating the effect of the individual mandate, and that ``the
estimated effects on the budget and health insurance coverage would
probably be smaller than the numbers reported in this document.'' In
other words, the CBO has publicly confirmed that its estimates are
likely overstated. As I said in my opening statement to the committee,
we must make health care more affordable, more available, and more
tailored to what individuals want and need in their care. The President
has made clear that any replacement system must make insurance more
affordable, have more choices, and be insurance that people want. In
addition, any system must effectively address the issue of risk
pooling, beyond mandates. I would look forward to working with Congress
and States in examining these alternative approaches. If confirmed, I
will commit to continuing to implement and enforce the laws within the
purview of the Department of Health and Human Services.
global health and taiwan
Question. Last spring, I sent then-Secretary Price a letter with 20
of my colleagues urging him to advocate for Taiwan's inclusion in the
World Health Organization's annual World Health Assembly (WHA). As the
SARS outbreak in 2002-2004 demonstrated, Taiwan's exclusion from the
World Health Organization has real-world costs and borders alone do not
stop the spread of infectious disease. Taiwan has been granted observer
status at the WHA since 2009, but this invitation was rescinded last
year at China's urging.
As the head of the U.S. delegation to the WHA, how will you work to
have Taiwan included in next year's WHA? Should Taiwan continue to be
excluded from the WHA, how will you ensure Taiwan has the same
resources to address public health issues as other partners in the
region?
The United States and Taiwan conduct joint public health training
exercises under the ``Global Cooperation and Training Framework''
(GCTF), which helps experts in the region prepare for Zika, Ebola,
MERS, Dengue Fever, and other communicable diseases.
If confirmed, how will you build on the success of the GCTF to help
Taiwan play its role in combating global health concerns?
Answer. I fully agree with you that global health security requires
all countries to help prevent, detect, control, and fight such
outbreaks of infectious diseases. I agree with you that Taiwan is a
valuable ally in the global health arena and deserves to be treated as
such.
If confirmed, I commit to working with the World Health
Organization (WHO) leadership to affirm Taiwan's observer status at
future World Health Assemblies.
colorectal cancer screening
Question. Seniors on Medicare undergoing a recommended
colonoscopy--which is used to screen for polyps that could become colon
cancer--are not supposed to pay any out-of-pocket costs. The rationale
is that when more seniors get screened for colon cancer in a timely
manner, cancer diagnoses can occur earlier and will be cheaper for
Medicare to treat; an advanced case of colorectal cancer can cost up to
$300,000 in treatment costs per year. However, there is a technical
loophole in Medicare by which seniors undergoing these ``free''
screening colonoscopies wake up and find they are faced with a surprise
bill of $300 or more due to biopsies taken under anesthesia.
I have introduced a bill that has 40 bipartisan cosponsors that
would fix this loophole. However, I want to encourage you in your
capacity as HHS Secretary, if confirmed, to examine any opportunities
to fix this problem without going through a long arduous legislative
process.
Are you aware of this loophole regarding colorectal cancer for
Medicare beneficiaries? If confirmed, will you examine administrative
fixes to the payment policy?
Answer. I appreciate you raising this issue. If confirmed, I commit
to working with CMS to make sure they thoroughly review the rules to
ensure they are implemented consistently with the law and with the
utmost regard for the accessibility of high quality health care for all
impacted Medicare beneficiaries.
pama implementation
Question. In 2014, Congress passed the Protecting Access to
Medicare Act (PAMA), which requires the Centers for Medicare and
Medicaid Services (CMS) to update the way clinical laboratories are
paid under the Medicare program through the development and
implementation of a new, mandatory reporting system and revised fee
schedule. On January 1, 2018 the CMS-proposed new CLFS rates went into
effect based on flawed data that does not represent all sectors of the
clinical laboratory market and therefore are not reflective of current
market rates.
I remain concerned that the proposed rule and implementation
timeline impose a significant burden on clinical laboratories across
the country and may threaten access to clinical laboratory services for
Medicare beneficiaries. I am also concerned with the quality of the
data collected by CMS--it reflects less than 1 percent of the market
and does not include an accurate representation across large and small
independent labs, hospital labs and physician office labs.
Will you commit to working with Congress and the laboratory
community to address these concerns?
The narrow definition of ``applicable'' lab as defined by CMS
resulted in a small group of labs deciding to report data. What would
you do as HHS Secretary to ensure data collection more accurately
reflects the entire clinical laboratory market?
Answer. I appreciate your concerns regarding the implementation of
PAMA. The use of laboratory reported, market data to establish Clinical
Laboratory Fee Schedule (CLFS) payment rates is intended to strengthen
Medicare by paying more appropriately for laboratory services and is
expected to save the Medicare program and taxpayers money while
maintaining beneficiaries' access to high quality laboratory services.
It is my understanding that the definition of applicable laboratories
was established through notice and comment rulemaking. Certainly, we
should strive for accuracy in this market data collection process. I
understand that in the Medicare Physician Fee Schedule proposed rule
for calendar year 2018 CMS solicited comments to better understand
applicable laboratories' experiences with the data reporting, data
collection, and other compliance requirements for the first data
collection and reporting periods under the new CLFS payment system.
Accordingly, I will ensure that CMS considers the comments for
potential future refinements to the data collection and reporting
periods and, if confirmed, I look forward to learning more about this
issue.
opioid data collection
Question. As I mentioned to you during your hearing, Ohio is second
only to our neighbor, West Virginia, when it comes to the rate of
overdose deaths due to opioids. In 2016, more than 4,000 Ohioans lost
their lives due to an opioid overdose.
Tackling the opioid epidemic requires reliable data for accurately
estimating the market forces that drive drug consumption and designing
appropriate interventions. It is crucial that the Federal Government
provide States with data that are reproducible and understandable
across a wide range of audiences.
As HHS Secretary, how would you collect this data, control for
quality, and distribute it in an accurate and timely manner to the
States?
Answer. One of HHS's goals under its five-point opioid strategy is
to strengthen public health data reporting and collection to improve
the timeliness and specificity of data and to inform a real-time public
health response as the epidemic evolves. Data is critically important
to monitoring and addressing this opioid epidemic, and I believe HHS,
through the CDC, plays an important role in surveillance of this
epidemic. If confirmed, I look forward to being briefed on the State of
our current data systems and working with the States to ensure they are
receiving needed data to adequately fight this epidemic.
low-income heating assistance program (liheap)
Question. As you know, the Low-Income Heating Assistance Program,
or LIHEAP, plays a key role in helping the elderly and low-income
families stay warm in the winter and avoid dangerous heat in the
summer. With the sustained cold in Ohio this winter, we see firsthand
how critical it is to the nearly 450,000 households in my State that
would otherwise be forced to choose between keeping warm or going
hungry. When your predecessor was before the committee, he indicated
that he supported this program, then he proceeded to eliminate it in
the FY18 budget request.
If confirmed, would you propose to once again eliminate the
program?
Answer. If confirmed, I will prioritize programs that demonstrate
results for the populations they intend to serve. If resources for
LIHEAP continue to be appropriated by Congress, I will continue to
implement the program in the most effective and efficient manner
possible.
accurate public health terminology at cdc
Question. A few weeks ago, several of my colleagues and I wrote to
CDC and HHS about the importance of using accurate, scientifically
sound terminology at the agency--including, but not limited to, in
budget documents. The CDC's ``Pledge to the American People'' states
that CDC will ``[b]ase all public health decisions on the highest
quality scientific data that is derived openly and objectively,'' and
``[p]lace the benefits to society above the benefits to our
institution.'' In order to carry out these promises, the agency must
remain steadfast in its commitment to the best science and the best
words to describe that science. It is essential that CDC rely on
science-based and evidence-based decisions, and use specific and
accurate language to promote its work.
You yourself have mentioned that the CDC and its career staff are
the envy of the world, that they have saved countless lives, and that
you will continue to advocate for CDC's funding to meet the challenges
of the 21st century if confirmed.
Do you believe that science and evidence should drive policymaking
decisions at CDC and HHS at large? Will you encourage your employees
and other administration appointees, both at HHS and across other
agencies you partner with, to use science and evidence to drive
policymaking?
If confirmed, would you permit employees across the agency to use
terms such as ``evidence-based'' or ``science-based'' in official HHS
communications?
Answer. Science and evidence should always be the basis of our
policymaking decisions, and my understanding is that there is no
attempt whatsoever to remove such words from official documents.
However, I want to make clear that, if I am confirmed, there would
never be a policy banning any words.
medicaid expansion
Question. As I mentioned during your hearing, Ohio's expanded
Medicaid program is critical to our State's fight against addiction.
Ohio's Governor John Kasich, in a letter to Senator Hatch last year,
wrote ``we strongly recommend that States be granted the flexibility to
retain the adult Medicaid coverage expansion and Federal matching
percentage.'' Governor Kasich's letter also said that those States that
have opted to expand Medicaid are experiencing significant positive
results.
In Ohio, high-cost ER utilization has gone down, overall health
status has improved for 48 percent of Ohioans, and most enrollees have
found it easier to keep or find work. Further, thanks to ACA's Medicaid
expansion, Ohio was able to extend coverage to 700,000 previously
uninsured Ohioans. The uninsured rate for low-
income adults in Ohio is the lowest ever recorded.
Do you support the flexibility provided to States under the ACA to
expand Medicaid? Will you continue to support this option for States?
As a cabinet-level advisor to the President, how will you advise
the President on any bill that would limit a State's flexibility to
expand Medicaid--like Ohio did--as provided for under the ACA?
Governor Kasich also has engaged providers, payers, community
organizations and employers to work with the Medicaid population and
provide a ladder out of poverty. One program in particular,
CareSource's Life Services pilot program provides supports, voluntary
educational and workforce training opportunities, and mentoring to help
individuals achieve physical and behavioral health and economic
stability.
As Secretary of Health and Human Services, how will you work to
expand support for voluntary programs like Life Services, which are
designed to help address both an individual's social determinants and
health needs?
Answer. We need reforms to give States as much freedom as possible
to design their Medicaid programs to meet the spectrum of diverse needs
of their Medicaid populations. Currently, outdated Federal rules and
requirements prevent States from pioneering delivery system reforms and
from prioritizing Federal resources to their most vulnerable
populations, which hurts access and health outcomes. Reforms can
incentivize and empower States to develop innovative solutions to
challenges like high drug costs and fraud, waste and abuse. We must
make health care more tailored to what individuals want and need in
their care. I believe States must have the flexibility to create the
best Medicaid program for their residents and be empowered to be fiscal
stewards of taxpayer dollars. If confirmed, I would support proposals
that would make the Medicaid program work better for the Americans who
rely on it. I also commit to working closely with States to ensure they
have the flexibility they need to serve the vulnerable populations the
Medicaid program is intended to assist.
medicare part d negotiations
Question. President Trump supports the elimination of the
noninterference clause in Medicare Part D. He would like to have the
Centers for Medicare and Medicaid Services (CMS) negotiate directly
with drug manufacturers to get the best deals on prescription drugs for
our Nation's seniors.
Your stance on this issue is less clear. While you seem to support
the role of pharmaceutical benefit managers (PBMs) as excellent
negotiators on behalf of the Federal Government when it comes to
Medicare Part D, you have seemed to point a finger at PBMs for the high
cost of prescription drugs in other circumstances.
Regardless of the role of PBMs, eliminating the noninterference
clause in Medicare Part D and providing the Secretary with formulary
authority would allow the Federal Government to get the best deals for
our Nation's seniors.
Given your prior work with the Medicare Part D program, if Congress
passes legislation supported by the President that gives the Secretary
of HHS the authority to negotiate--and this legislation is signed into
law--would you use this administrative authority to negotiate better
prices on behalf of the more than 40 million Part D beneficiaries?
What are your ideas on effective ways to reduce out-of-pocket
prescription drug costs for Medicare beneficiaries?
Answer. Drug prices are too high. The President has made this
clear. Through my experience helping to implement Part D and with my
extensive knowledge of how insurance, manufacturers, pharmacy, and
government programs work together, I believe I bring skills and
experiences to the table that can help us address these issues, while
still encouraging discovery so Americans have access to high-quality
care.
The President has generally spoken about the desire to ensure that
Medicare is negotiating and getting the best deal possible for drugs.
Part D plans are actually negotiating today with the three or four
biggest pharmacy benefit managers that negotiate and actually secure
the best net pricing of any players in the commercial system. If
confirmed, I would like to consider further ways that we can take the
lessons from Part D to improve Medicare.
antibiotic resistance
Question. The first incidence of the bacteria E. coli containing
the antibiotic resistance gene mcr-1 was discovered in 2015. This gene
has the capability of promoting the bacteria to ``superbug'' status by
conferring resistance to the last resort antibiotic colistin. Since
2015, the mcr-1 gene has been found in bacteria in over 30 countries
from around the world. The emergence of this superbug is extremely
serious and illustrates both how quickly infectious pathogens can
spread across the world and the need for international cooperation in
detecting newly emerging health threats.
Do you agree that a dedicated effort to improving surveillance,
data collection and research efforts is needed to prevent such rapid
spread and evolution of antibiotic resistant bacteria?
How will you ensure that the threat of antimicrobial resistance
remains a high priority for the U.S. Department of Health and Human
Services (HHS) and its affiliates the National Institutes of Health
(NIH), Food and Drug Administration (FDA), and CDC? How should the
United States work with other nations to combat these threats?
Answer. One of our largest public health threats is antibiotic drug
resistance. If confirmed, I will work with all agencies involved in
antibiotic drug development--including FDA, CDC, and BARDA--to ensure
the department is involved and supportive of antibiotic drug
development and is working with stakeholders, such as physicians and
nurses, to ensure strong antibiotic stewardship programs are in place
and implemented. I agree with you that improving surveillance is also
important and commit to working internally on this issue but also with
our global partners.
infant mortality
Question. Ohio consistently ranks among the top 10 States in the
country with the highest overall rates of infant mortality. African
American babies in Ohio, in particular, suffer disparately high rates
of infant mortality. I have introduced legislation to improve
prevention efforts nationwide by improving Federal reporting of infant
and childhood deaths, putting the power in the hands of the Secretary
of HHS to generate the metrics by which these incidences are reported.
As HHS Secretary, how would you work to ensure adequate funding for
the issue of infant mortality, and which metrics and protocols would
you use to improve reporting of infant mortality cases across the
country?
Answer. If confirmed, I commit to reviewing the current resources
available and ensuring that these resources are used wisely. I look
forward to being briefed on the state of current infant mortality
metrics and protocols, and I commit to working on this issue.
lead
Question. Last year, the CDC lowered its reference level for public
health intervention for elevated childhood blood lead levels from 5 to
3.5 micrograms per deciliter.
Lead is a neurotoxin, and exposure to it can have devastating
lifelong consequences for children. Ohio is one of 29 States receiving
funding from CDC for a State-wide lead poisoning prevention program. In
2014, almost 6,000 children under age six in Ohio, or 3.85 percent of
those tested, had elevated blood lead levels.
If confirmed, will you keep the CDC's lowered lead reference level?
What actions would you have HHS take to reduce the number of
American children with elevated blood lead levels?
According to a Reuters investigation in 2016, our country is
failing when it comes to screening and testing at-risk children for
lead. Millions of at-risk children are never screened or tested for
high lead levels, despite early childhood lead screening and testing
requirements.
What proposals do you have to increase the rate of lead screening
in children? How will you use the authorities you have under Medicaid
and CHIP to increase the number of at-risk children who are screened
for high lead levels?
Answer. It is important that every child has access to high-quality
health coverage and that we take all health-care threats to our
children seriously, including high lead levels. Medicaid and CHIP play
an important role in accomplishing this objective, but there is also a
need to focus on family coverage in the private market and employer
plans, as well as giving States flexibility to address the unique needs
of their communities. Each State is different. HHS should work with
States to ensure that their children's program provide the best
possible coverage to their residents. If confirmed, I would ensure that
CDC continues its science-based work with respect to lead reference
levels.
lgbtq health disparities
Question. According to the Office of Disease Prevention and Health
Promotion (ODPHP,) research suggests that LGBTQ individuals face health
disparities linked to societal stigma, discrimination, and denial of
their civil rights. These disparities are driven in part by lower rates
of health insurance in the LGBTQ community, as many employers do not
offer coverage for same-sex partners or their children. The ACA made
significant strides in addressing LGBTQ health disparities, by ensuring
that the LGBTQ population cannot be excluded from health plans due to
pre-
existing conditions such as HIV, prohibiting marketplace discrimination
based on sex and gender identity, and requiring that insurance plans
offer the same coverage to married same-sex couples that is offered to
opposite-sex couples. The ACA also required the inclusion of sexual
orientation and gender identity variables in national health surveys.
As HHS Secretary, do you commit to working to eliminate health
disparities across populations, including the LGBTQ community?
Will you ensure that married same-sex couples are offered equal
opportunities for insurance coverage?
Will you commit to collecting data on sexual orientation and gender
identity, and using this information to guide evidence-based policy to
address health disparities?
Answer. If confirmed, I will work to enhance and protect the health
and well-being of all Americans. Americans have equal rights under the
law, without distinction, and the government cannot deny any individual
access to health care for illegally arbitrary reasons. If confirmed I
will ensure HHS will faithfully implement the anti-discrimination
protections contained in the laws passed by Congress.
340b
Question. CMS recently finalized its 2018 Medicare Hospital
Outpatient Prospective Payment Program System, which--despite a
significant amount of pushback from the stakeholder community and many
members of Congress--included a provision to change Medicare's
reimbursement for discounted drugs under the 340B program to 340B
hospitals to -22.5 percent as compared to the prior (and current rate
for non-340B hospitals) of ASP +6 percent. I am concerned by these
cuts, which do not save the Medicare program any money and will
disproportionally affect hospitals serving Ohio's most vulnerable
individuals.
During your confirmation hearing in front of the Senate Finance
Committee, you said several times that one of your focus points for
reducing the price of drugs will be to focus on what the patient pays
in out-of-pocket costs, including copays. While the proposal CMS OPPS
proposal that was finalized may reduce some out-of-pocket costs for
Medicare beneficiaries who are faced with high drug costs, it
redistributes that higher out-of-pocket burden across Medicare
beneficiaries receiving other services. If we are to be serious about
lowering the cost of prescription drugs, we should do so in a way that
truly lowers the cost of the drug--not by paying some hospitals less
than others and shifting out-of-pocket copay and coinsurance burden
from individuals with high drug costs to those with high procedure
costs.
What are your views on the 340B drug discount program?
Do you believe in supporting safety-net providers who are working
to help low-income individuals access quality health services through
programs such as 340B?
What are your proposals for working with all stakeholders in this
space--including the provider community--to ensure the 340B program
aligns with congressional intent and meets the needs of communities?
Answer. I understand that CMS recently finalized a change for 2018
to the Medicare payment rate for certain Medicare Part B drugs
purchased by hospitals through the 340B Program in order to lower the
cost of drugs for seniors and ensure that they benefit from the
discounts provided through the program. The reduced payments on 340B
purchased drugs would better align with hospital acquisition costs and
directly lower drug costs for those beneficiaries who receive a covered
outpatient drug from a 340B participating hospital by reducing their
copayments by an estimated $3.2 billion over 10 years. Certain
hospitals are exempted from this Medicare payment reduction for 340B
drugs such as rural sole community hospitals, prospective payment
system-exempt cancer hospitals and children's hospitals. Additionally,
all critical access hospitals are not affected by this policy because
they are not paid under the outpatient prospective payment system. If
confirmed, I will faithfully implement any laws related to the 340B
program as passed by Congress, and I look forward to working with
Congress and stakeholders to ensure that the 340B program is putting
patients first.
community services block grant
Question. The administration proposed to eliminate all funding for
the Community Services Block Grant (CSBG) in FY2018. If this were to
take place, it could result in a complete dismantling of the Community
Action network, which is uniquely required to identify and address
local causes and conditions of poverty. While CSBG allotments are a
relatively small component of the overall budget for many Community
Action Agencies (CAA), designation as CSBG eligible entities and the
flexibility of their CSBG allotments help CAA agencies bring a wide
variety of public and private resources into local communities. CSBG
funds are critical to helping address both chronic and short-term
critical needs, and support many innovative activities that help
promote self-sufficiency. In the absence of CSBG funding, many of these
initiatives would lack financial backing.
Do you know if HHS has made any efforts to analyze the unintended
consequences of eliminating the CSBG? For example, if the CSBG were to
be eliminated, to what extent would State and local governments face
pressure to compensate for services now provided through CAAs?
Will you commit to, if confirmed, protecting the CSBG and ensuring
that communities do not lose these cost-effective resources?
Answer. If confirmed, I look forward to working with leadership at
the Administration for Children and Families, Congress, and States to
identify the most effective programs that alleviate the very real
problems of families living in poverty.
______
Question Submitted by Hon. Sherrod Brown, Hon. Michael F. Bennet,
and Hon. Robert P. Casey, Jr.
provider status
Question. The Pharmacy and Medically Underserved Areas Enhancement
Act recognizes pharmacists as health-care providers in underserved
areas in order to expand access to care. In areas with a shortage of
primary-care providers, pharmacists may play a key role in helping
patients manage their diseases to avoid Emergency Department visits and
hospitalizations. These services are especially important for patients
with multiple chronic conditions who may be taking several medications
at a time.
As HHS Secretary, would you support this approach as a way to
increase care in rural and underserved areas?
Answer. If confirmed, I look forward to learning more about your
legislation and working with you to increase access to quality health
care, especially in rural and underserved parts of the country.
______
Questions Submitted by Hon. Sherrod Brown
and Hon. Bill Cassidy
delivery system reform and social determinants of health
Question. Last fall, we wrote to then-Secretary Price asking him to
work with us to convene a diverse commission of national health care
experts to develop a strategy for improving and advancing our Nation's
health care delivery system so that can effectively meet the needs of
all Americans. What we wrote then is still true now: in many ways, the
United States is the envy of the world when it comes to health care. In
other ways, our country continues to lag behind others when it comes to
health-care efficiency and effectiveness. In 2016, we spent more than
18 percent of our national gross domestic product on health care, yet
we spent more to treat disease than prevent it in the first place. Our
system of care delivery is complicated and remains siloed, and we
struggle to address health disparities that divide us by race,
socioeconomic status, and geography, and our public health outcomes are
stagnant.
We are ready to work together and with health-care experts across
the country, including community health partners, providers, patients,
payers, and clinicians, to develop a new approach to health care
delivery in the United States.
If confirmed, will you help us shift the government's focus from a
system that simply treats the sick, to a system that keeps Americans
healthy, regardless of where they live, their race, or their
socioeconomic status?
Will you commit to working with us to identify innovative thought
leaders from around the country to help achieve the following goals?
Evaluate our current health care delivery system;
Assess the improvements our Nation must make to reduce
disparities and deliver the highest quality, most affordable
care to all Americans;
Encourage innovation in clinical and community approaches;
Improve the health and well-being of individuals and
communities; and
Build a thoughtful framework for future health-care reforms.
Answer. As I indicated in my opening statement, one of my top
priorities as Secretary, if confirmed, will be to use the power of
Medicare and Medicaid to drive transformation of our health-care system
from a procedure-based system that pays for sickness to a value-based
system that pays for quality and outcomes. If given the opportunity to
serve I will use the appropriate tools within the Department to meet
this goal and measure our progress in reaching it. If confirmed, I look
forward to working with you and hearing your ideas on how we can
identify reforms and ensure that all Americans have access to the
highest quality care. I also look forward to coordinating with CMS,
their Innovation Center, States, and others in the Department as they
work toward fostering an affordable, accessible health-care system that
puts patients first. I believe we need to review the work of the
Department periodically to identify what's working and what is not. I
also firmly believe that Department authorities must be used in ways
that are open and transparent and that seek out collaboration and input
as much as possible. In that spirit, I look forward to working closely
with you to identify and implement needed reforms and drive
improvements in our health-care system.
______
Questions Submitted by Hon. Michael F. Bennet
Question. Press reports have highlighted that we should soon expect
an executive order on welfare reform and the President has made
multiple comments on the topic. Last month, Paul Ryan also stated,
``we're going to have to get back next year at entitlement reform,
which is how you tackle the debt and the deficit.''
The President has not said what he means by ``welfare'' or what he
is referring to when he says, ``People are taking advantage of the
system.''
Have you had any conversations with the President or administration
officials related to their ideas on ``welfare reform''?
If confirmed as Secretary, how would you advise the President on
his goals of reforming welfare?
Given that welfare and entitlement reform may be on the priority
list for next year, can you provide a clear view of what ``welfare
reform'' means or should mean?
Answer. I see a lot of opportunity to improve the efficiency and
effectiveness of our welfare programs for our beneficiaries and
taxpayers. If confirmed, I will work across the department to
prioritize reforms that maintain an emphasis on national values of
community engagement and personal responsibility. Responsible reforms
should focus on reducing burdens and inefficiencies and should
recognize that States are in a better position than the Federal
Government to operate programs that best meet the needs of their
citizens. I see the Federal Government's role as a catalyst for
engaging all sectors of the community to develop and implement a shared
vision to grow the capacity and reduce the dependency of economically
and socially vulnerable populations.
Question. In the past, you have touted the success of Medicare Part
D, stating that it would ``[provide] high-quality, affordable drug
coverage to beneficiaries'' in 2006. Part D beneficiaries may have
access. However, the largest barrier to accessibility is affordability
due to high drug prices for consumers, which has also meant higher
government spending. Federal payments for catastrophic coverage tripled
from $10.8 billion in 2010 to over $33 billion in 2015. In 2015, only
two drugs accounted for almost $8 billion of the $33 billion.
How would you improve Medicare Part D to address these price
increases?
Do you see any need for the government to negotiate for extremely
high cost drugs that have no competition?
Answer. Part D has worked to make prescription drugs available and
affordable to millions of our seniors. Medicare Part D prescription
drug program access will also remain strong in 2018 with 100 percent of
people with Medicare having access to a stand-alone prescription drug
plan. Earlier this year, CMS announced that the average basic premium
for a Medicare prescription drug plan in 2018 is projected to decline
to an estimated $33.50 per month. This represents a decrease of
approximately $1.20 below the average basic premium of $34.70 in 2017.
The Medicare prescription drug plan average basic premium is projected
to decline for the first time since 2012. But for a senior who has to
pay out of pocket during their deductible or in the donut hole, high
list prices can make certain drugs unaffordable for some beneficiaries.
As I stated in my testimony, I believe drug prices are too high. My
experiences at HHS, helping to implement Medicare's Part D prescription
drug program and in the private sector have provided me with a deep
understanding of the many factors that influence and determine the
prices patients are paying for their medications. If confirmed, I am
committed to working with Congress to address the challenges that are
contributing to higher drug prices to ensure when seniors go into the
pharmacy, they can afford the medications they need to improve their
health and well-being.
Question. In Colorado, we have a teen pregnancy prevention program,
which promotes long-acting reversible contraception or LARCs. This
initiative resulted in lowering the State's teen pregnancy by over 50
percent and saving $65 million in health-care costs over 8 years.
Through this statewide program, these contraceptives are available at
75 Colorado family planning clinics.
Would you consider this program a success story?
Given the success stories of the teen pregnancy prevention program,
why is the administration seemingly moving to eliminate the TPPP
program, having cut short the grants from 5 to 2 years?
Answer. We all share a commitment and desire to decrease unintended
teen pregnancies, but we should do so through programs that the
evidence suggests actually contribute to a decline in teen pregnancy
rates. With respect to the Teen Pregnancy Prevention Program, I
understand that an evaluation of a number of TPP projects published in
2016 on the HHS website showed that many were ineffective or actually
harmful and that few showed sustained positive results.
Question. We saw several versions of ACA repeal and replace last
year. Each of these proposals would have meant massive cuts to
Colorado, especially in the Medicaid program, which stood to lose up to
50 percent in funding. You had said, ``I think there's a lot to commend
[about] a block grant approach, because the States are the laboratory
for experimentation.''
While our State has sought more flexibility, our Governor said,
``Greater flexibility cannot make up for the lack of funding. Should
the Federal Government pull back its financial commitments, we simply
cannot afford to make up the difference.'' While that flexibility is
important, it is meaningless if States do not have adequate resources.
Do you agree with our governor's assessment?
Do you still support the block grant and per capita cap approach?
Answer. We need reforms to give States as much freedom as possible
to design their Medicaid programs to meet the spectrum of diverse needs
of their Medicaid populations. Currently, outdated Federal rules and
requirements prevent States from pioneering delivery system reforms and
from prioritizing Federal resources to their most vulnerable
populations, which hurts access and health outcomes. Reforms like block
grants, when paired with additional authority and flexibility, can
incentivize and empower States to develop innovative solutions to
challenges like high drug costs and fraud, waste and abuse. We must
make health care more tailored to what individuals want and need in
their care. As I said before the committee, the details of any block
grant approach are incredibly important. The details determine whether
States are receiving adequate funding and whether the approach is
providing States with the flexibility they need. I believe States must
have the flexibility to create the best Medicaid program for their
residents and be empowered to be fiscal stewards of taxpayer dollars.
If confirmed, I would support proposals that would make the Medicaid
program work better for the Americans who rely on it.
Question. The death rate from drug overdoses, including legal and
illegal opioids, has been climbing in Colorado. Heroin overdose deaths
increased by 23 percent in 2016 from the previous year. Neonatal
abstinence syndrome went up by 83 percent from 2010 to 2015. The
Colorado Health Institute recently found that 31 out of 64 counties in
the State do not have a location that provides medication-assisted
treatment. They also found that large parts of the State are not within
a 30-mile radius of any treatment center. Even when treatment centers
are close by, there could be wait times because of the surge in
patients.
Medicaid has been a vital program for Americans struggling with
addiction. About one in three Americans who gained access to health
care through the Medicaid expansion had a mental health or substance
use disorder for which they were able to receive treatment. Republican
proposals to repeal and replace the ACA included Medicaid cuts that
would have dramatically reversed any progress we have made in
combatting the opioid crisis.
Can you commit that you would oppose similar bills that would
worsen this epidemic at a time when we need to invest in more
treatments and resources?
Answer. I am committed to ensuring that HHS brings all it has to
bear in fighting the opioid epidemic. If confirmed, I look forward to
working with Congress to ensure that legislation supports our efforts
to address this crisis.
Question. When Congress passed Medicare Part D in 2003, it had a
public option as a fallback for areas with little competition in the
market. The fallback would have kicked in even in areas that had one
private plan for a total of at least two plans. The fallback was
ultimately never triggered but there was agreement that sometimes the
private sector cannot or will not, participate in certain markets,
especially in rural areas that are more difficult to cover.
My colleague, Senator Kaine, and I introduced the Medicare-X Choice
Act, which would create a public option run through the Medicare
program. It would first start in regions where insurance companies have
stopped offering services or there is only one health plan on the
exchange. In our proposal, the Medicare public option would then extend
to all counties and on the small business exchange.
Do you think a public option would be helpful in areas with little
competition in the individual market, specifically in rural counties
where there may only be one plan?
Answer. I share your commitment and concern for access to rural
health care and affordable insurance options, and, if confirmed, I look
forward to working with you on these issues. However, I am concerned
that a Medicare-based public option could stifle innovation and
exacerbate some of our current challenges. It is also important to
recognize that Medicare is a heavily subsidized program, so I'm not
sure an unsubsidized Medicare benefit to non-senior individuals would
be an affordable option. Right now, we have a system where Washington
is too often in the driver seat and defining what is health care, and
that is taking away choices and the ability of individuals and families
to find the care they need. We need a system that is responsive to all
Americans and where both health coverage and health care are affordable
and accessible. I do share your concern about access to affordable and
accessible health insurance for individuals, especially in these
circumstances, and look forward to working with you and others, if
confirmed, to try to develop a system that actually delivers these
types of solutions for those who are in the marketplace and for those
who have been denied the promise of the marketplace.
Question. Consumers tend to be largely unaware of what they will be
billed after having a test or procedure. Common surgeries like a knee
replacement could cost anywhere between $11,000 and $70,000 depending
on where you live.
What steps will you take as HHS Secretary to improve price
transparency for consumers and policymakers?
Answer. I favor increased transparency within our health-care
system, and I especially share your concern about transparency of
pricing for the patient at the point of care delivery or sale. Of
course, the goal of transparency is ultimately to create more
competition and lower prices, so we do need to make sure transparency
is not counter-productive. I would be very happy to study the issue
more and work with you to ensure that all options are evaluated as we
think about this important issue, and to help make sure that our
policies related to transparency will actually aid patients in making
choices and lower costs and reduce what patients pay out of pocket.
Question. In 2014, CMS promulgated a rule in the Home and
Community-Based Services waiver program that directly conflicted with
Colorado's Community Centered Boards system. The CMS rule, which is now
adapted in Colorado law, will lead to major changes in the way that
families access the system of care that CCBs currently operate.
As CMS and States move forward with the implementation of the
conflict free case management rule, how can we help ensure that
families and individuals do not lose access to the case workers and
providers with whom they have developed relationships?
Answer. I understand that promoting community integration for older
adults and people with disabilities remains a high priority for CMS. If
confirmed, I look forward to reviewing and helping to improve the work
underway at the Federal and State level in implementing the regulation
that finalized criteria for home and
community-based settings appropriate for the provision of HCBS.
Question. In 2015, over 428,000 children were in foster care
nationally. Parental substance use is cited as a reason for removing
children from families in 32.2 percent of cases.
If confirmed as Secretary of HHS, what policies will you recommend
to address this population of children and their families that are
affected by the opioid crisis?
Answer. Addressing the opioid crisis is a top priority for the
Department of Health and Human Services. It is critical that we address
the unique needs of children in foster care as a result of parental
substance use. If confirmed, I commit to working with all relevant
agencies within HHS to address this problem.
Question. I worked with Senator Portman to introduce the Medicare
PLUS Act, which would set up a pilot program to manage the sickest and
the highest-cost Medicare beneficiaries by coordinating their health-
care needs through an Accountable Care Organization or Medicare
Advantage plan. As you may know, 15 percent of Medicare beneficiaries
have six or more chronic conditions and account for 50 percent of total
Medicare spending.
If confirmed as Secretary of HHS, what steps will you take to pilot
this program and ensure that these patients receive the coordinated
care they need?
What other plans do you have to advance the use of alternative
payment models such as Accountable Care Organizations?
Answer. I look forward to learning more about the Medicare PLUS
Act. One of my top four priorities as Secretary, if confirmed, will be
to use the power of Medicare and Medicaid to drive transformation of
our health-care system from a procedure-based system that pays for
sickness to a value-based system that pays for quality and outcomes. If
we start from the principle of empowering patients and putting their
needs first, we can reform our health insurance system to realize
efficiencies, reduce health-care spending and improve patient care. If
confirmed, I will strive to work with staff across HHS to make health
care more affordable, more available, and more tailored to what
individuals need in their care. I look forward to working with Congress
and the staff at HHS to identify and execute reforms that will put
patients and beneficiaries first.
______
Questions Submitted by Hon. Robert P. Casey, Jr.
help committee qfrs
Question. Historically, nominees to be Secretary of the Department
of Health and Human Services have answered questions for the record
from both the HELP Committee and the Finance Committee. Former
Secretary Price did not respond to HELP questions for the record and
you have yet to respond to them either, despite having received them on
December 1, 2017. Accordingly, I have attached the questions my
Democratic colleagues and I submitted for that hearing for you to
respond to here.
Answer. I have--and will continue to--faithfully comply with the
rules of both the committee and the Senate to the best of my ability.
As the Senate Finance Committee is the committee of jurisdiction, I
provided answers to those questions for the record first. However, I am
glad to submit answers to the HELP Committee questions as promptly as
possible.
medicaid and chip
Question. This administration has pushed to repeal the Patient
Protection and Affordable Care Act, an action that would end the
expansion of Medicaid to millions of people and would result in
significant cuts to State budgets. This action would throw millions of
people into the realm of the uninsured, including hundreds of thousands
with disabilities. They would no longer have access to such services
and treatments as behavior health care, mental health treatment, and
preventative services. The services provided by Medicaid expansion have
greatly improved the quality of life for millions of citizens,
particularly those with disabilities. [1] Do you propose those
individuals return to being uninsured? Do you propose that their health
care, including mental health treatments, be discontinued? Do you
support returning hundreds of thousands of people with disabilities
into the category of the uninsured?
Answer. As I noted before the committee, we need reforms to give
States as much freedom as possible to design their Medicaid programs to
meet the spectrum of diverse needs of their Medicaid populations.
Currently, outdated Federal rules and requirements prevent States from
pioneering delivery system reforms and from prioritizing Federal
resources to their most vulnerable populations, which hurts access and
health outcomes. To address concerns that the ACA's expansion of able-
bodied adults without children has impacted access to Medicaid services
for Americans with disabilities, we need to customize our programs and
benefits to the characteristics of our beneficiaries and allow for
States to best serve their most needy citizens by providing them
flexibility while also holding them accountable. I firmly believe that
States are best positioned to make these decisions, and if confirmed, I
will work with States to ensure they have the flexibility and authority
they need to structure their Medicaid programs in ways that best meet
the unique needs of their populations.
Question. If plans to create per captia allotments or block grants
for Medicaid are implemented, many people with disabilities will lose
Medicaid coverage. Those individuals with disabilities depend on
Medicaid for services that are unavailable through private insurance
such as personal care services, respite care, or intensive mental
health services. These health, personal care, and preventative services
allow individuals to live in the neighborhoods of their choice, be
independent, work, and participate in their communities. Many of these
people, capable, able people, will potentially be forced into
institutions if they lose access to these crucial services. How will
you ensure that this group of Americans retains the needed supports and
services to remain in their own homes and active members of their
communities?
Answer. As I said above and before the committee, the details
around financing and flexibility are key to evaluating any block grant
reform approach, including those proposed last year. Medicaid is a
single program dealing with many completely different population
subgroups, including for the first time under the expansion, able-
bodied adults without children. To address concerns that the ACA's
expansion of able-bodied adults without children has impacted access to
Medicaid services for Americans with disabilities, we need to customize
our programs and benefits to the characteristics of our beneficiaries
and allow for States to best serve their most needy citizens by
providing them flexibility and holding them accountable. I firmly
believe that States are best positioned to make these decisions, and if
confirmed, I will work with States to ensure they have the flexibility
and authority they need to structure their Medicaid programs in ways
that best meet the unique needs of their populations.
Question. Federal flexibility in Medicaid has allowed Pennsylvania
to take extra steps to ensure that children with extensive health care
needs have access to Medicaid, in what's referred to as Family of One
program. This program, in addition to the Medicaid expansion for
parents, has improved the economic security of families in
Pennsylvania. The State's budget relies on the Federal share in order
to support these Medicaid programs. However, the budget in the House
last year would have cut Medicaid funding by $1 trillion dollars, about
one-third over a 10-year period. Given that half of Medicaid enrollees
in this country are children, how will you ensure that children and
families aren't harmed by cuts in Medicaid funding through block
grants?
Answer. As I said above and before the committee, the details
around financing and flexibility are key to evaluating any block grant
reform approach, including those proposed last year. We need reforms to
give States as much freedom as possible to design their Medicaid
programs to meet the spectrum of diverse needs of their Medicaid
populations. Currently, outdated Federal rules and requirements prevent
States from pioneering delivery system reforms and from prioritizing
Federal resources to their most vulnerable populations, which hurts
access and health outcomes. Reforms like block grants, when paired with
additional authority and flexibility, can incentivize and empower
States to develop innovative solutions to challenges like high drug
costs and fraud, waste, and abuse. We must make health care more
tailored to what individuals want and need in their care. I believe
States must have the flexibility to create the best Medicaid program
for their residents and be empowered to be fiscal stewards of taxpayer
dollars. If confirmed, I would support proposals that would make the
Medicaid program work better for the Americans who rely on it.
Question. Medicaid covers a broad range of services to address the
diverse needs of the populations it serves. In addition to covering the
services required by Federal Medicaid law, many States elect to cover
optional services such as prescription drugs, physical therapy,
eyeglasses, and dental care. Coverage for Medicaid expansion adults
contains the ACA's 10 ``essential health benefits,'' which include
preventive services and expanded mental health and substance use
treatment services. Medicaid provides comprehensive benefits for
children, known as ``EPSDT,'' that are considered a model of
developmental pediatric coverage. EPSDT is especially important for
children with disabilities because private insurance, which is designed
for a generally healthy population, is often inadequate to their needs.
Unlike commercial health insurance and Medicare, Medicaid also
covers long-term care, including both nursing home care and many home
and community-based long-term services and supports. More than half of
all Medicaid spending for long-term care is now for services provided
in the home or community that enable seniors and people with
disabilities to live independently rather than in institutions. Given
that both EPSDT for kids and long term services and supports are not
generally covered in commercial health plans. How will you ensure that
these essential services are retained given the policy proposals to
block grant Medicaid or to place a per capita cap on recipients?
Answer. As I discussed above, we need reforms to give States as
much freedom as possible to design their Medicaid programs to meet the
spectrum of diverse needs of their Medicaid populations. Currently,
outdated Federal rules and requirements prevent States from pioneering
delivery system reforms and from prioritizing Federal resources to
their most vulnerable populations, which hurts access and health
outcomes. Reforms like block grants, when paired with additional
authority and flexibility, can incentivize and empower States to
develop innovative solutions to challenges like high drug costs and
fraud, waste and abuse. We must make health care more tailored to what
individuals want and need in their care. I believe States must have the
flexibility to create the best Medicaid program for their residents and
be empowered to be fiscal stewards of taxpayer dollars. If confirmed, I
would support proposals that would make the Medicaid program work
better for the Americans who rely on it.
Question. Forty percent of Pennsylvanian children rely on Medicaid
and CHIP, which serves our State's most vulnerable children: children
living in or near poverty; infants, toddlers, and preschoolers during
key developmental years; children with special health care needs; and
children who have been place in foster care due to neglect or abuse.
Medicaid's comprehensive, pediatrician-recommended services under
EPSDT--Early and Periodic Screening, Diagnostic and Treatment
services--are critical for their health and to ensure that they hit key
development milestones. In recent years, there is clear evidence of the
long-term return on investments in Medicaid. Children enrolled in
Medicaid are healthier as adults and more likely to graduate from high
school, attend college, resulting in greater economic success. Do you
support the EPSDT benefit package for children which ensures that
America's most vulnerable children receive the services they need to
thrive? Are you willing to protect these benefits by not allowing
States to waive this important benefit?
Answer. Medicaid and CHIP are a critical part of the safety net for
millions of American children who are exactly the type of vulnerable
beneficiaries that these programs are intended to serve. If confirmed,
I will support continued coverage of EPSDT services for children in
Medicaid consistent with the Department's statutory obligations.
Question. The health repeal bills from last year that the Trump
administration supported would have given States an option to block
grant Medicaid, leading to the elimination of many critical patient
protections. With our current Medicaid structure, children have a right
to the full array of services they need, from critical health
screenings for cancer treatment to services for children with autism or
mental health needs. For many children, this coverage can be the
difference between life and death. Medicaid as currently structured
also enables children with disabilities to live up to their potential,
be successful in school, and have the opportunities to be full
citizens. Do you support the continuation of Medicaid's requirement to
cover a comprehensive array of services for children through the Early
Periodic Screening Diagnosis and Treatment (EPSDT) program? Will you
commit to ensuring that HHS will actively enforce the requirement to
provide screenings, diagnosis, and treatment for children with
disabilities or with potential disabilities?
Answer. As I said above, Medicaid and CHIP are a critical part of
the safety net for millions of American children. If confirmed, I will
support continued coverage of EPSDT services for children in Medicaid
consistent with the Department's statutory obligations.
Question. Many people with disabilities want to work and can do so
with the home and community based services only available through
Medicaid, to help them work. These services include supported
employment for people with mental health disabilities or personal care
attendants for those with intellectual or physical disabilities.
Without these services, many people with disabilities will be unable to
work. How will you ensure that a person with a disability, mental
health, intellectual, physical, sensory, or any other type of
disability as defined by the Americans with Disabilities Act, has
access to the services currently available through Medicaid?
Answer. Ensuring access to care for people with disabilities is a
central promise of the Medicaid program. If confirmed, I would make
sure that HHS follows the law and continues to engage stakeholders in
the disability community to ensure these individuals have access to
high-quality care.
Question. As economies evolve, professions change and while new
types of jobs emerge, certain types of jobs are reduced or eliminated
and workers must make transitions. This happens to people across the
workforce, but it happens almost twice as often to workers with
disabilities. Do you support taking away people's Medicaid coverage
because they lose their jobs? Do you support work requirements as an
eligibility for Medicaid? How will you ensure that people with
disabilities who become unemployed are able to retain Medicaid
benefits?
Answer. Medicaid is a single program dealing with many completely
different population subgroups, including for the first time under the
expansion, able-bodied adults without children. We need to customize
our programs and benefits to the characteristics of our beneficiaries.
While I have not been involved with CMS's efforts to allow States to
implement work and community engagement requirements in their Medicaid
programs, I do believe there is significant evidence that one of the
best ways to improve the long-term health of low-income Americans is to
empower them with skills and employment, for those who are able to
work. If confirmed, I look forward to working with States to give them
additional flexibility, while holding them accountable to ensure
patient access to high quality health care.
Question. In 1999, in the Olmstead decision, the U.S. Supreme Court
agreed that individuals with significant disabilities have the right,
under the Americans with Disabilities Act, to access services in the
community rather than only in an institutional setting. Since the
Olmstead decision, the U.S. Department of Health and Human Services has
employed its authority over Medicaid waivers to encourage States to
expand home and community-based services and to shift away from
overreliance on institutional care. Will you continue this longstanding
Federal policy? If no, why not? If yes, what steps will you take?
Since the Olmstead decision, Congress has authorized several
programs to incentivize States to meet their obligations under the
Olmstead decision by increasing Federal dollars for providing
community-based services. These programs include the Money Follows the
Person program, the State Balancing Incentive Program, the Community
First Choice State Plan option, and the Home and Community Based
Services option. These programs are implemented and managed through the
Department of Health and Human Services. Is it your view these programs
should continue? Why or why not?
Answer. I and the administration support the availability of home
and community-based services for those for whom that is a better
setting than an institutional setting. There is important work underway
at the State level in implementing the home and community based
services regulation that finalized criteria for home and community-
based settings appropriate for the provision of home and community
based services. State partners, stakeholders representing beneficiaries
and their families, providers, and other community organizations have
been collaborating with the Federal Government, and with each other, to
develop transition plans that would make the reforms described in the
regulation a reality for over a million Medicaid beneficiaries
receiving home and community based services. If confirmed, I would
continue to work with States to implement these programs.
Question. The proposals from congressional Republicans over the
past year have called to change Medicaid from a program that includes
an open-ended Federal financial commitment to fixed block-grant
payments to the States. Would this change end the Federal oversight and
incentive programs that have helped State systems transform into
systems that allow individuals with significant disabilities to live in
the community? How would you ensure that any changes in Medicaid would
not move people with disabilities back into nursing homes and other
institutional settings that are linked to significantly poorer quality
of life, physical and mental health outcomes, and longevity?
Answer. Ensuring access to care for people with disabilities is a
central promise of the Medicaid program. If confirmed, I look forward
to working with States to give them additional flexibility, while
holding them accountable to ensure patient access to high quality
health care.
Question. In 2011, the Department of Health and Human Services
promulgated a rule to ensure that Medicaid funds designated for
services in home and community-based settings were not used to fund
services in segregated, institutional settings. For example, the second
floor of a building used to provide inpatient hospital care could not
be considered a community-based setting. That rule has been championed
by the disability community as critical to afford people with
disabilities the chance to live independent and fulfilling lives in
their own homes and communities. Do you support the continuation of
this rule? Do you commit to ensure that HHS assertively enforces it?
Answer. Ensuring access to care for people with disabilities is a
central promise of the Medicaid program. If confirmed, I would make
sure that HHS follows the law and continues to engage stakeholders in
the disability community to ensure these individuals have access to
high-quality care.
Question. A major focus in recent years has been on pursuing
delivery system reforms that improve quality and reduce costs. The
Federal Government over time has focused more on the needs of children
in these reforms, but Medicaid for children still lags behind Medicare
in supporting improvements in care. What steps will you take to promote
increased emphasis on reforms targeting the unique needs of children?
Answer. We need reforms to give States as much freedom as possible
to design their Medicaid programs to meet the spectrum of diverse needs
of their Medicaid populations. Currently, outdated Federal rules and
requirements prevent States from pioneering delivery system reforms and
from prioritizing Federal resources to their most vulnerable
populations, which hurts access and health outcomes. Reforms like block
grants, when paired with additional authority and flexibility, can
incentivize and empower States to develop innovative solutions to
challenges like high drug costs and fraud, waste and abuse.
Medicaid is a safety net program that provides life-saving medical
care to millions of Americans facing some of the most challenging
health circumstances. The program currently faces significant
challenges. If confirmed, I will work every day to implement the laws
that Congress passes, and to help provide health insurance that works
for Americans and meets their unique needs, particularly our most
vulnerable populations that the Medicaid program is intended to serve.
Question. To ensure kids continue to receive the critical care they
need under Medicaid, any potential restructuring needs to consider
children's unique health care needs and the impact of limiting our
investments into their future and the Nation's as a whole. Any reforms
must ensure children's funding is stable, clearly defined, protects
current services, and begins to remediate shortages in critical areas,
such as mental and behavioral health services. How will you ensure that
Medicaid continues to deliver essential services tailored to the unique
needs of children?
Answer. It is a priority of mine and this administration that every
child has access to high-quality health coverage. Medicaid plays a
significant role in accomplishing this objective, but there is also a
need to focus on family coverage in the private market and employer
plans, as well as giving States needed flexibility. If confirmed, I
will work to create a health insurance system that is more affordable
and responsive to the needs of individuals and their families so that
we have a health-care system that is more affordable and accessible,
especially for children.
medicare
Question. Too often, I hear from constituents who struggle to
understand when to sign up for Medicare Part B. As a result, too many
older Pennsylvanians and people with disabilities are paying lifetime
late enrollment penalties or going without needed health care simply
because of an honest mistake.
In 2016, nearly 700,000 with Medicare were paying a Part B Late
Enrollment Penalty (LEP) and the average LEP amounted to a 31 percent
increase in a beneficiary's monthly premium. For a senior living on a
fixed income who is paying the standard Part B premium in 2017--$134
per month or over $1,600 per year--this lifetime penalty presents a
significant hardship.
Medicare Part B enrollment rules are more than 50 years old and
sorely in need of updating. Importantly, we should look to align Part B
enrollment rules with newer programs, like Medicare Advantage and Part
D. [2] Further, the Federal Government does little to notify and
educate individuals who are not auto-enrolled into Part B about what a
person's responsibilities are and what consequences can result if
someone delays Part B enrollment. Mr. Azar, if confirmed, will you
commit to enhanced education for those approaching Medicare eligibility
about the rules of the road? Will you work with Congress to modernize
outdated rules and prevent Medicare Part B enrollment errors?
Answer. CMS's top priority must be to put patients first, and I
understand that CMS has established an internal process to evaluate and
streamline regulations with a goal to reduce unnecessary burden,
increase efficiencies, and improve the beneficiary experience.
CMS should always make sure that seniors are in the driver's seat
of their health care and have necessary, timely, and accurate
information to make health-care decisions. If confirmed, I will work
with CMS to make sure beneficiaries and individuals eligible for
Medicare have the information they need to make decisions about the
coverage that best fits their needs.
Question. The State Health Insurance Assistance Programs (SHIPs),
known as the APPRISE program in Pennsylvania, are the only source of
unbiased, one-on-one Medicare counseling for older adults and people
with disabilities. In 2015, over 7 million people with Medicare
received help from SHIPs. Since 1992, counseling services have been
provided via telephone, one-on-one in-person sessions, interactive
presentation events, health fairs, exhibits, and enrollment events.
Individualized assistance provided by SHIPs almost tripled over the
past 10 years.
Administered by the U.S. Department of Health and Human Services'
(HHS's) Administration for Community Living (ACL), this modest program
operates in every State and U.S. territory and has been significantly
underfunded for years. And despite growing need, as 10,000 Baby Boomers
become Medicare eligible daily, this administration recommended zeroing
out funding for the program. This is not the right path forward for the
Nation or for Pennsylvania. Mr. Azar, will you pledge to support
funding for SHIPs?
Answer. For older adults, people with disabilities and their
families, identifying what services and supports are available,
understanding how to access them, and navigating the systems that
provide them can be overwhelming. If confirmed, I look forward to
working with all parties to ensure that older adults, people with
disabilities, and their families understand the choices and services
available to them and how to access them.
Question. Opioid misuse is becoming a growing concern in the aging
community as many older adults are prescribed opioids for chronic pain
and other conditions. HHS' Inspector General (IG) found that in 2016,
approximately 500,000 Medicare Part D beneficiaries received high
amounts of opioids. The IG also found that nearly 90,000 of these
beneficiaries were at risk of misuse or even overdose.
Though Medicare beneficiaries should have access to medication
needed to maintain their health, we must also safeguard them from
inadvertently becoming a part of the opioid epidemic. Also, we must
make resources available to beneficiaries who do become addicted. If
confirmed, how will you ensure that Medicare beneficiaries are using
opioids in a way that will not harm them in the long term?
Experts have indicated that medication-assisted treatment (MAT),
which combines behavioral therapy and medication, can be effective in
recovery from opioid use disorder. Methadone is one of the MAT
medications used in more severe cases of addiction but is currently not
covered under Medicare Part B (outpatient coverage) or Part D
(prescription drug coverage) because the way in which it is dispensed
does not line up with the requirements for coverage. Beneficiaries who
would benefit from methadone should not miss out on its benefits
because of seemingly unintended consequences of the law. Do you believe
that beneficiaries should have access to methadone in these cases? If
so, what will you do to ensure that they do?
Answer. As I mentioned during my hearing, addressing the opioid
epidemic will be one of my top four priorities, if confirmed.
Overprescribing of opioids is still a major problem, and I know that
HHS is currently ramping up its efforts to address the problem from
both the provider and the patient side. For instance, CDC has developed
guidelines for providers, while at the same time has launched a media
campaign targeting patients. SAMHSA provides educational tools to help
providers identify signs of prescription drug abuse or doctor shopping.
Additionally, CMS has taken numerous steps to combat opioid abuse in
Medicare including the use of the Overutilization Monitoring System
(OMS) to help ensure that prescription drug plan sponsors have
established reasonable and appropriate drug utilization management
programs. I understand CMS also released an interactive online mapping
tool to assist health-care providers in assessing opioid-prescribing
habits while ensuring patients have access to the most effective pain
treatment and that beneficiaries' personal health care information is
secure. These educational tools can aid providers who are serving
Medicare beneficiaries. In addition, it is critical that we educate
beneficiaries about the potential harms of opioid abuse and misuse. I
believe that medication-assisted treatment is an important element of
recovery for many individuals and that we should work to ensure that
patients have access to the care that they need.
Question. Most seniors and people with disabilities live on low and
fixed incomes, with more than half of people with Medicare living on
only $26,200 per year or less. Older adults spend upwards of $5,000 per
year on out of pocket health-care costs, including deductibles,
premiums, and copayments. In September 2017, CMS released a Request for
Information (RFI) for the Center for Medicare and Medicaid Innovation
(Innovation Center) which appeared to be seeking input on models to
radically restructure Medicare, including premium support (or Medicare
vouchers) and private contracting.
While the RFI does not explicitly mention the terms ``premium
support'' or ``Medicare voucher,'' the ambiguity of the proposal allows
for a variety of interpretations. I interpreted the language in the RFI
to mean that CMS is considering models that would fundamentally
restructure the guaranteed benefit traditional Medicare provides to
older adults and people with disabilities through a premium support
model. Did CMS intend to seek comment on a premium support model? If
no, please clarify the type of model CMS is seeking input on in this
RFI.
The RFI also seeks input on private contracting, a practice in
which Medicare beneficiaries would be required to negotiate their out-
of-pocket health-care costs directly with their providers. This
practice undermines protections Congress put in place more than 30
years ago to ensure that Medicare providers fairly bill older adults
and individuals with disabilities who have Medicare. If you become
Secretary, will you commit to upholding existing balance billing
protections? Further, will you refrain from allowing private
contracting through CMMI models, specifically any practices that would
force people with Medicare to negotiate out-of-pocket costs directly
with their provider?
I am also troubled by the disregard of normal process for posting
the RFI. The RFI was posted to the Innovation Center website, but not
formally included in the Federal Register. This practice creates
unnecessary barriers to review and comment submission. The RFI also
includes a statement that ``CMS may publicly post the comments
received,'' which creates a concern that CMS is attempting to obfuscate
regular process in order to withhold unfavorable comments from public
view or decide against responding to certain comments. Mr. Azar, if you
are Secretary, do you agree to make public the more than 1,000 comments
submitted on the Innovation Center RFI?
My concern about this RFI is compounded by the fact that the
proposals under consideration may not allow for Medicare beneficiaries
to maintain choice and that beneficiaries may not have the ability to
opt out of Innovation Center models. I am concerned about this premise,
especially since providers will be allowed to opt out of such models.
Mr. Azar, if you become Secretary, can you assure that Medicare
beneficiaries are notified and educated about their involvement in
Innovation Center models and given the choice of participating?
Similarly, how would you guarantee that beneficiary protections,
including opt-out mechanisms, are incorporated into model design?
Answer. One of my top four priorities as Secretary, if confirmed,
will be to use the power of Medicare and Medicaid to drive
transformation of our health-care system from a procedure-based system
that pays for sickness to a value-based system that pays for quality
and outcomes. CMMI will be a critical part of these efforts. Of course,
we must exercise the power of CMMI and other authorities in ways that
are open and transparent, and that seek out collaboration and input as
much as possible. I am not familiar with any details or deliberative
process behind the most recent actions cited in this question, but if
confirmed, I look forward to exploring models that reduce costs and
increase quality for Medicare beneficiaries, taking full advantage of
the stakeholder input CMS receives through the recent RFI.
Question. Telemedicine has helped to bring specialty care to rural
and underserved areas across the country, but there are barriers within
the Medicare and Medicaid programs that have hampered this progress. Do
you support removing barriers to telemedicine under Medicare and
Medicaid and what role do you see for telemedicine in the coming years?
Answer. Telehealth can provide innovative means of making health
care more flexible and patient-centric. Innovation within the
telehealth space could help to expand access to care within rural and
underserved areas. With respect to Medicare, the Centers for Medicare
and Medicaid Services (CMS) recently sought information regarding ways
that it might further expand access to telehealth services within the
current statutory authority and pay appropriately for services that
take full advantage of communication technologies. I understand that
CMS is carefully reviewing comments and considering commenters'
suggestions for future rulemaking and any appropriate sub-regulatory
changes. If confirmed, I look forward to continued discussions on
telehealth, including on the best means to offer patients increased
access, greater control and more choices that fit their medical needs.
children's issues
Question. You have hardly any record on child welfare issues. The
largest Federal investment in child welfare is made through title IV-E
of the Social Security Act, which reimburses States for activities
associated with foster care, and it is managed by the Department of
Health and Human Services. While foster care is a critical, often life-
saving intervention, we should be moving toward a system that not only
supports children who can no longer remain safely with their families,
but one that also helps stabilize struggling families so that they can
keep their children when it is possible to do so safely. This focus on
prevention is not only often in the best interest of children, but also
in the best interest of State budgets, and States that have started
shifting to a prevention-focused model have seen lower downstream costs
associated with foster care, homelessness, health care and criminal
justice. This is an especially critical issue right now, at a time when
we are seeing foster care caseloads increasing as a result of the
opioid epidemic. How will you, as Secretary of Health and Human
Services, prioritize investments in services aimed at helping
vulnerable families?
Answer. If confirmed, I will continue the collaborative work that
the Children's Bureau, within the Administration for Children Youth and
Families at ACF, has begun with the Department of Education (ED)
providing the tools and resources necessary to connect education and
child welfare agencies across the country. In addition, I look forward
to working with States to help them improve outcomes for child welfare
involved children and families.
Question. Will you commit that, if confirmed as Secretary of Health
and Human Services, you will take action to guarantee parents coverage
of and access to mental health and substance use disorder services, to
prevent child abuse and neglect, and help reunify families?
Answer. I am committed to ensuring that all individuals have access
to the necessary mental health care they need. Children, in particular,
are an important subset of the population, and I would work to review
current programs at HHS that target treatment for children.
Question. Currently, when families adopt children with special
needs from foster care, those children are guaranteed Medicaid coverage
through the age of 18. This is an important support for these children
and their adoptive families. If confirmed as Secretary of Health and
Human Services, what assurances can you give to these children and
their adoptive parents that their health care needs will continue to be
met?
Answer. It is important that every child has access to high-quality
health coverage. Medicaid certainly plays a role in accomplishing this
objective, so it is of paramount importance to provide States
flexibility to address the unique needs of their communities. If
confirmed, I look forward to partnering with the States to ensure that
families who adopt children benefit from access to high-quality health
care.
Question. Recently, there have been reports that ``welfare reform''
would be a priority for the coming year. What programs within and
outside of HHS do you consider to be ``welfare'' and what reforms and
changes do you think need to be made to these programs?
Answer. There are many programs both within and outside HHS that
have come to comprise the economic safety net for low-income families.
The 1996 welfare reform law tackled a subset of those, with a key
outcome being the replacement of the Aid for Families with Dependent
Children (AFDC) cash assistance program with the Temporary Assistance
for Needy Families (TANF) program. I see a lot of opportunity to
continue to make improvements to the efficiency and effectiveness of
welfare programs for beneficiaries and taxpayers, and, if confirmed,
will continue to look for ways to improve HHS programs, whether
considered welfare or not, to better meet the needs of the people they
assist. If confirmed, I will work across the Department to prioritize
reforms that maintain an emphasis on national values of work, community
engagement, and personal responsibility. Responsible reforms should
focus on reducing burdens and inefficiencies and should recognize that
States are in a better position than the Federal Government to operate
public benefit programs that best meet the needs of their citizens. I
see the Federal Government's role as a catalyst for engaging all
sectors of the community to develop and implement a shared vision to
grow the capacity and reduce the dependency of economically and
socially vulnerable populations.
Question. In 2015, Congress recognized the importance of high-
quality early learning and care by authorizing a new Preschool
Development Grants program in the bipartisan Every Student Succeeds Act
(ESSA PDG). As the Secretary of HHS, you will be responsible for
implementing this important program, along with the Secretary of
Education. Under ESSA PDG, Congress explicitly allowed States to use
funds to promote access to high-quality early learning and care during
the renewal period. If confirmed, will you commit to respecting this
allowance and helping States to increase the number of low- and
moderate-income served in high-quality early learning and care
programs?
Answer. If confirmed, I will work with the Assistant Secretary for
Children and Families and the Secretary of Education to implement the
PDG program as specified by the authorizing legislation, with an
emphasis on State leadership and flexibility in high-quality, mixed-
delivery, comprehensive early childhood State systems that provide low-
income children from birth through age 5 and their families with
supports to assist these children to be successful in school and
beyond.
Question. Oftentimes, changes in the larger health-care landscape
take place, for example in the Medicaid program, without a full
examination of how these changes could potentially impact children,
even inadvertently. As you look at health-care changes at the national
level as Secretary, how will you ensure that children's unique health-
care needs are taken into account?
Answer. Medicaid has been the safety net for many vulnerable
American children. If confirmed, I will support continued coverage of
services for children in Medicaid consistent with the Department's
statutory obligations.
Question. Children's health-care needs are unique and electronic
health records play an important role in guaranteeing the care our
children receive is appropriate and safe. The 21st Century Cures Act
included a provision instructing the Secretary of Health and Human
Services to issue draft criteria for the voluntary certification for
pediatric health information technology. Developing pediatric specific
standards will help ensure our children are getting age appropriate
vaccines and tests and coordinate care for children with complex
medical needs. If confirmed, what steps will you take to ensure that
electronic health records are meeting the needs of our children?
Answer. I am committed to the goals of the 21st Century Cures Act.
It is vitally important to make sure that all Americans have access to
high quality health care and we know that care would benefit from the
use of EHR technology.
the opioid epidemic
Question. According to the recent Facing Addiction: Surgeon
General's Report on Alcohol, Drugs, and Health, ``Substance misuse and
substance use disorders are estimated to cost society $442 billion each
year in health-care costs, lost productivity, and criminal-justice
costs.'' The National Survey on Drug Use and Health (NSDUH) reported in
2015 that 21.5 million people in the United States, over 8 percent of
the population, had a substance use disorder. [3] The Center for
Disease Control and Prevention reported over 52,000 drug overdose
deaths in 2015. [4] Of the millions of people struggling with a
substance use disorder, only about 10 percent receive substance use
disorder treatment in a given year. [5] If confirmed as Secretary of
Health and Human Services, what actions will you take to address the
needs of Americans struggling with substance use disorders, especially
those who are seeking treatment?
Answer. It is extremely important that individuals with substance
use disorder be able to access treatment. The improvement of access to
prevention, treatment, and recovery services is one point of HHS' five-
point strategy to address the opioid epidemic. If confirmed, I would
continue to support efforts at the Department to advance improved
access to these services.
Question. If confirmed as Secretary of Health and Human Services,
will you commit to supporting, and as a Cabinet member advising the
President to support, continued funding for opioid crisis grants, as
administered by SAMHSA?
Answer. If confirmed, I commit to reviewing the current resources
available and ensuring that these resources are used wisely. I will
support continued funding to address the opioid crisis.
Question. If confirmed as Secretary of Health and Human Services,
will you commit to supporting, and as a Cabinet member advising the
President to support, funding for the Substance Abuse Prevention and
Treatment Block grant to preserve the critical safety net for Americans
who require substance abuse treatment but who are uninsured?
Answer. If confirmed, I commit to reviewing the current resources
available and ensuring that these resources are used wisely. I will
support continued funding to address the opioid crisis.
Question. If confirmed as Secretary of Health and Human Services,
would you commit to supporting, and as a Cabinet member advising the
President to support, funding requests for the National Institute of
Mental Health and the National Institute on Drug Abuse to develop
better treatments for substance use disorders?
Answer. If confirmed, I commit to reviewing the current resources
available and ensuring that these resources are used wisely. I will
support continued funding to address the opioid crisis.
Question. Integrated primary care and mental health care is one
promising strategy to improving outcomes for Americans with substance
use disorders. If confirmed as Secretary of Health and Human Services,
will you support demonstration programs--which as Secretary you would
have the ability to direct--to integrate primary and behavioral health
care, through the Center for Medicare and Medicaid Innovation?
Answer. As I noted above, one of my top four priorities as
Secretary, if confirmed, will be to use the power of Medicare and
Medicaid to drive transformation of our health-care system from a
procedure-based system that pays for sickness to a value-based system
that pays for quality and outcomes. CMMI will be a critical part of
these efforts. Of course, we must exercise the power of CMMI and other
authorities in ways that are open and transparent, and that seek out
collaboration and input as much as possible. I would be very interested
in working with you on any proposals and ideas you have to address
critical issues of public health, including integrated proposals
related to the treatment of substance use disorder. It is my
understanding that CMS recently issued a Request for Information
seeking feedback on a new direction for CMMI, in which it notes that it
is interested specifically in proposals for payment models and State
and local interventions to improve care in areas of opioids and
substance abuse. I look forward to learning more about proposals
seeking to achieve these goals.
liheap
Question. The Low-Income Home Energy Assistance Program (LIHEAP)
provides short-term aid to vulnerable populations for heating or
cooling assistance, crisis assistance or weatherization assistance.
Without this support, many low-income participants would quickly fall
behind on their bills and face shut-off of essential energy services.
The program effectively utilizes a partnership between the Federal
Government, State government and the private sector.
LIHEAP protects the most vulnerable in our society. According to
the Campaign for Home Energy Assistance, in Pennsylvania in 2014, 35
percent of households receiving LIHEAP were elderly, 30 percent were
disabled, and 18 percent had children under 5. You were a member of the
Task Force on Poverty, Opportunity, and Upward Mobility that drafted
the ``A Better Way'' plan that proposed to combine LIHEAP with 10 other
social program grants to create a large block grant to States. Should
such a plan come to pass, it would eliminate a dedicated fund for
utility crisis assistance. In addition, your recent budget took across
the board cuts from safety net programs and highlighted LIHEAP as one
of several ``duplicative anti-poverty programs.'' While the Department
of Energy also oversees an energy program (the Weatherization
Assistance Program), this program provides grants to States to improve
the weatherization and energy efficiency of low-income homes. Thus,
serving a different, though just as important, service from LIHEAP?
Can you explain why you think LIHEAP is a duplicative anti-poverty
program and which other programs in particular you think are providing
the same services?
According to the National Energy Assistance Directors Association,
States have been forced to reduce the number of households served by
LIHEAP from 8 million to the current level of 6.7 million due to
Federal cuts to the program. This equates to 1.3 million eligible
households nationwide that did not receive assistance.
Answer. I am not familiar with the Task Force on Poverty,
Opportunity, and Upward Mobility, and I did not participate in that
drafting of the ``A Better Way'' plan.
Question. LIHEAP is a critical safety net program to support the
elderly and families as the country recovers from the economic
recession. Families should not have to choose between heating their
homes and putting food on the table. You have previously voted in the
House of Representatives against increasing funding for LIHEAP.
Do you support increasing funding for LIHEAP? If not, why do you
not support it?
Will you support maintaining the funding at the current level of
$3.3 billion in the President's final recommendations for FY 2017 and
proposed FY 2018 budget?
Answer. I never served in the House of Representatives.
If confirmed, I will prioritize programs that demonstrate results
for the populations they intend to serve. If resources for LIHEAP
continue to be appropriated by Congress, I will continue to implement
the program in the most effective and efficient manner possible.
hiv/aids
Question. Many agencies within HHS share responsibility for
implementing policies to address the public health problems of HIV and
hepatitis. Fortunately, we have made significant steps in recent years
to treat these diseases, reduce their transmission, and in the case of
hepatitis C, even cure the disease. Despite this progress, there are
still 37,600 new cases of HIV in the United States each year, and only
approximately half of people living with HIV have been identified and
treated so that they are virally suppressed. Additionally, nearly
20,000 people die each year from hepatitis C and its complications,
which exceeds deaths from HIV and many other nationally notifiable
disease combined. The opioid epidemic is also driving a surge in new
hepatitis C infections. As a result, I am extremely concerned about
actions that could hamper our progress in combating these communicable
diseases.
What are your plans to continue the progress made in fighting HIV?
How will HHS, under your leadership, work to combat the increasing
rates of hepatitis due to the opioid epidemic?
Will you appoint new members of the President's Advisory Council on
HIV/AIDS?
Will you commit to implementing the National HIV/AIDS Strategy and
the National Viral Hepatitis Action Plan?
Answer. If confirmed, I am committed to ensuring HHS remains a
world leader in HIV/AIDS prevention and treatment strategies and
research. I look forward to reviewing both the National HIV/AIDS
Strategy, as well as the National Viral Hepatitis Action Plan, and
working with stakeholders to reduce new infections and improve access
to care and treatment outcomes. The rising rates of infectious diseases
and other health consequences associated with injection drug use are of
great concern. Syringe Services Programs have been highly effective in
certain places, such as Scott County, Indiana. If Congress should
decide to continue funding for support of SSPs, I would ensure that
these programs are fully implemented, consistent with such laws. If
confirmed, I would also ensure that we continue our education of
individuals about the risks associated with opioid misuse and abuse.
Addressing the opioid crisis would be one of my top four priorities, if
confirmed, and I would be pleased to work with you on this issue. If
confirmed, I look forward to appointing new members to the President's
Advisory Council on HIV/AIDS and reviewing the National HIV/AIDS
Strategy and the National Viral Hepatitis Action Plan.
aca sabotage and transparency
Question. At your hearing in front of the HELP Committee, we had
the opportunity to discuss the Trump administration's sabotage of the
Affordable Care Act. Despite a host of actions the administration has
taken to deliberately undermine the ACA, at least 8.7 million people
have signed up for 2018 Marketplace coverage. There is clearly a high
demand for these plans. One wonders how many more people would have
signed-up for coverage if the administration had maintained prior
education and outreach efforts.
At your HELP Committee hearing, I told you that your past hostility
toward the Affordable Care Act made me concerned that the sabotage of
the ACA will continue under your watch. I recently received a document
from HHS that details how the administration secretly plotted behind
closed doors with congressional Republicans on regulatory changes to
undermine the ACA. HHS refused to share this document with me and other
members of Congress for over 8 months, with no reasonable basis to
withhold it.
Now, it has come to our attention that HHS has developed a list of
hundreds of other regulatory actions to sabotage the ACA. On December
21, 2017, I, along with Ranking Member Wyden and others, requested HHS
provide this document, but HHS has once again refused to share
information with Congress by stating that it is ``unable to release
information pertaining to planned regulatory actions.''
At the HELP hearing, you told me that if the ACA remained the law
of the land, it would be your job to implement it as faithfully as
possible. Not only does the ACA remain the law of the land, it is clear
that the majority of the people support it and want it to succeed. As
such, if you are confirmed, do you believe it is important to be
transparent and accountable to Congress for programs it has
established, including providing information in a timely manner when
requested?
Answer. I agree that it is important for HHS to be transparent and
accountable to Congress on matters involving Federal programs, which
includes responding to congressional inquiries within a reasonable
time.
Question. Congress has a constitutional responsibility to conduct
oversight of the executive branch to ensure the faithful implementation
and administration of policies enacted by Congress. Withholding
information for more than 8 months and refusing to provide information
to Congress about planned regulatory actions is an assault on Congress
as a co-equal branch of government. Congressional oversight and
administration transparency are especially important when
administration actions and policies are clearly aimed at undermining
legislative intent and sabotaging a program established by Congress, as
seems to be the case here. If you are confirmed, do you commit to
providing the document detailing the more than 200 planned regulatory
actions that were developed and maintained by HHS in a timely manner
and without redactions?
Answer. I am not familiar with such a document, but if confirmed as
Secretary, I will review this matter immediately and assess whether
disclosure of any such documents is lawful and appropriate.
cooperation
Question. Earlier this year, there were reports that the White
House instructed agencies not to cooperate with Democratic requests for
information. I saw this lack of responsiveness firsthand as HHS failed
to respond to multiple letters I had sent. In July, Marc Short, the
White House's Director of Legislative Affairs, stated in a letter to
Senator Grassley that it was ``[t]he administration's policy to respect
the right of all individual members, regardless of party affiliation,
to request information'' and that ``the executive branch should
voluntarily release information to individual members where possible.''
After this clarification regarding the administration's policy, I
started to receive responses from HHS to some of my letters, but the
responses have been wholly inadequate. HHS has often failed to respond
to the questions posed in the letters, HHS has declined to make certain
officials available for briefings with my staff, and HHS has refused to
provide documents to me even when those documents have already been
shared with other members of Congress.
If you are confirmed, do you commit to providing thorough,
complete, and timely responses to requests for information from all
members of Congress, including requests from members in the Minority?
Answer. If confirmed, I will work with my staff to ensure that the
Department's responses to requests from Congress are timely,
appropriate, and reasonable.
Question. If you are confirmed, do you commit without reservation
to take all reasonable steps to ensure that you and your agency
complies with deadlines established for requested information?
Answer. Yes, I will take all reasonable steps to try to ensure that
the Department meets all relevant deadlines.
Question. Do you believe the administration should provide
documents to Congress when requested absent a legal basis for
withholding them?
Answer. Yes.
lgbtq issues
Question. During the campaign, President Trump said that he would
``do everything in [his] power to protect LGBTQ citizens.'' The
administration has failed to live up to that promise. In particular,
HHS has taken numerous actions that will make it more challenging for
its programs to serve LGBTQ Americans. In the spring, HHS eliminated
sexual orientation and gender identity questions on two data collection
instruments used to evaluate the effectiveness of Older Americans Act
programs and programs designed to serve people with disabilities. In
October, HHS withdrew a proposed rule that would have ensured that
same-sex spouses were recognized and afforded equal rights in long-term
care facilities that receive Medicare and Medicaid funds. Furthermore,
this administration has eliminated provisions from the HHS homeless
youth Street Outreach Program designed to protect LGBTQ youth and
specifically focus on the needs of LGBTQ youth. Ranking Member Murray,
myself, and many members of this committee have urged HHS to reverse
course on all of these actions. Will you commit to reviewing all of
these actions and ensure that key HHS programs will fully consider and
meet the needs of the LGBTQ population?
Answer. If confirmed, I will do everything in my power to ensure
that all Americans have meaningful access to medical care. I will work
to ensure that the Department continues to empower patients and
consumers so that they will have increased access to medical care,
health, and wellness. Our Nation's health-care system is founded on the
respect for the human person, evidence-based research, and effective
medical treatment. It must be a system that treats each patient with
the respect that they deserve, in compliance with the law.
ninety-five percent of children are insured
Question. In the last several years, we have made enormous progress
in ensuring that every child has access to health insurance, through
the Children's Health Insurance Program, Medicaid, and other programs.
The Patient Protection and Affordable Care Act has reduced the number
of uninsured children under age 18 from over 9 million in 2012 to 3.7
million in 2015. Another 3 million young adults between the ages of 19
and 26 have also received coverage thanks to the ACA. You have been
clear that you support repealing the law. I am deeply concerned about
the impact that would have on the number of uninsured children and
young adults.
As HHS secretary, will you guarantee that under your leadership,
the number of uninsured children will not increase and their coverage
will cover all medically necessary care?
Will you commit to ensuring that we will maintain the current level
of insurance among children and young adults?
Answer. It is important that every child has access to high-quality
health coverage. CHIP and Medicaid play an important role in
accomplishing this objective, but there is also a need to focus on
family coverage in the private market and employer plans, as well as
giving States needed flexibility. If confirmed, I am committed to
working to provide high quality health insurance to children and young
adults.
The status quo is not working for millions of Americans--whether it
is those who are in the insurance market or those who have been left
out of it. If confirmed, I will work to create a health insurance
system that is more affordable and responsive to the needs of
individuals and their families so that we have a health-care system
that is more affordable and accessible.
pregnancy assistance fund
Question. As a part of the Affordable Care Act, I advocated for the
Pregnancy Assistance Fund, a $250-million, 10-year program to support
pregnant and parenting teens and young women. The program, which is
funding projects in 20 communities around the Nation, supports efforts
to keep these young parents in school so that they will be able to
support their children upon completing their educations, and promotes
connections to local services and supports that can help young
families. The Pregnancy Assistance Fund is administered by the
Administration for Children and Families (ACF). While the first two
rounds of grant funding were for 3 years, the most recent round of
funding, in FY 2017, was for just 1 year. I am concerned that HHS has
shortened the grant periods from 3 years to 1, as of this year, and I
am concerned that this could have an adverse impact on the ability of
grantees to enroll participants in their programs when future funding
is uncertain. Will you commit to working with me to extending this
program past 2019?
Answer. I agree that it is important to encourage pregnant and
parenting teens and young women to complete their educations and
connect them with supports that can help young families. If confirmed,
I commit to learning more about this program and working with you in
the future.
disabilities
Question. In 1999, in the Olmstead decision, the U.S. Supreme Court
clearly found that individuals with significant disabilities have the
right, under the Americans with Disabilities Act, to access services in
the community rather than only in an institutional setting. Since the
Olmstead decision, the U.S. Department of Health and Human Services has
employed its authority to encourage States to expand home and
community-based services and to shift away from over-reliance on
institutional placement and care versus support and independence. The
right to home and community-based supports is established law and long
instituted policy. If confirmed, will you continue this commitment and
protect people with disabilities from the threat of
institutionalization?
Answer. Since January, my understanding is that the administration
has worked with State partners and other stakeholders to implement
provisions of a final regulation defining home and community-based
setting. In the upcoming years, if confirmed, I will work with the
Department to examine ways in which it can improve engagement with
States on the implementation of the home and community based services
rule, including greater State involvement in the process of assessing
compliance of specific settings. I would also continue to work with
States on home and community based programs that meet the needs of
those who rely on them, including those with disabilities.
Question. Mr. Azar, in 2008, Congress passed, by an overwhelming
bipartisan majority, the Americans with Disabilities Act Amendments
Act. This law clarified the intent of Congress to include people with
epilepsy, diabetes, AIDS, and other long-term health conditions, as
people with disabilities and thus protected by the law. Your
predecessor, Dr. Price, voted against this legislation. I'd like to
know where you stand on this issue. Do you think people who get
treatment for disabilities such as epilepsy and diabetes should not be
protected from discrimination by the ADA?
On a similar note, do you think it should be legal to discriminate
against people with chronic health conditions?
The bills offered over the past 10 months to repeal and replace the
Affordable Care Act would have made it possible to discriminate against
those with pre-
existing conditions. This was one of the foundational principles of the
ACA and one of the most important components of the ADA to the general
public. In Pennsylvania, 5.5 million people have pre-existing
conditions. Just a few of the conditions that counted as pre-existing
before we banned insurance companies from denying coverage to people
with existing conditions include: cancer, mental illnesses, diabetes,
epilepsy, multiple sclerosis, pregnancy.\12\ Will you commit to
supporting the ACA's ban on discrimination on the basis of pre-existing
conditions?
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\12\ http://kff.org/health-reform/issue-brief/pre-existing-
conditions-and-medical-underwriting-in-the-individual-insurance-market-
prior-to-the-aca/.
Answer. The President has made clear that any replacement system
must make insurance more affordable, have more choices, and provide the
insurance coverage that people need. In addition, any system must
effectively address the issue of risk pooling, beyond mandates. I would
look forward to working with Congress and States in examining these
alternative approaches. As I said in my opening statement to the
committee, we must make health care more affordable, more available,
and more tailored to what individuals need in their care. If confirmed,
I will commit to continuing to implement and enforce the laws within
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the purview of the Department of Health and Human Services.
Question. Mr. Azar, before the ACA, people with pre-existing health
care conditions, including children with cerebral palsy, Down syndrome,
leukemia, hemophilia, and diabetes, would simply be cut off from health
coverage when they hit their annual limits or their lifetime limit,
regardless of their immediate or long-term health care needs. Do you
think that someone with a congenital disability, a chronic condition,
or an acquired long-term disability, who needs significant health care
treatment and supports, should be excluded from coverage after a
financial cap is reached? Will you commit to supporting the ACA's ban
on both annual and lifetime limits?
Answer. As stated above, the President has made clear that any
replacement system must make insurance more affordable, have more
choices, and provide the insurance coverage that people need. In
addition, any system must effectively address the issue of risk
pooling, beyond mandates. I would look forward to working with Congress
and States in examining these alternative approaches. If confirmed, I
will commit to continuing to implement and enforce the laws within the
purview of the Department of Health and Human Services.
Question. With major demographic changes occurring in the United
States there is a great need for racial and ethnic minority mental
health professionals as well as health professionals who, themselves,
have disabilities. How will you work to promote Federal efforts to
increase the numbers of individuals from diverse ethnic backgrounds and
individuals with disabilities to enter into health professions as well
as increase the cultural and disability competence of our health
workforce?
Answer. America is facing a real workforce shortage especially in
the field of mental health, and it is an issue that I look forward to
addressing, if confirmed. I know that SAMHSA and HRSA, in particular,
are involved with programs that aim to address the workforce shortage
and encourage individuals from diverse backgrounds to pursue health
professions. I look forward to learning more about these programs and
ensuring that we are working to solve the problem of a mental health
workforce shortage.
Question. Mr. Azar, there has been extensive focus on employer
wellness programs during the past decade with many companies using the
current maximum penalty of 30 percent of the cost of the group health
plan (employer and employee share) if an employee does not participate.
Evidence is mounting that such penalties do not significantly increase
participation in workplace wellness programs. Moreover, such penalties
disproportionately affect low-income workers and those with unseen
disabilities that they may not wish to disclose. Such penalties force a
person to either reveal their health-care status to their employer or
pay a significant financial penalty, on average, $5,000 per family. Do
you believe that workers who choose to keep their health information
private from their bosses should be forced to pay that kind of penalty?
Answer. Employer wellness programs have been highly successful in
encouraging individuals to improve their health. Each program is unique
and tailored to the employer's workforce, and must be reviewed
individually to determine whether it is compliant with current
regulations. I believe we should continue to study the impact financial
and other incentives and behavioral economic interventions might have
on employee wellness and behavioral health.
Question. Mr. Azar, the current director of the Centers for Disease
Control and Prevention has publicly announced that she will be
reorganizing the Centers. The National Center for Birth Defects and
Developmental Disabilities has been critical in responding the
increased incidence of autism and other developmental disabilities,
including such congenital disabilities as Down syndrome and other
trisomy syndromes. Your predecessor called for a 12-percent cut to the
CDC budget through the elimination of the Public Health and Prevention
Fund, a fund that supports many of the efforts of the NCBDDD and which
helps to inform families, physicians, and health-care providers about
autism and developmental disabilities. Do you support less information
being shared with self-advocates, families, and health-care providers
about autism and developmental disabilities?
Answer. I support CDC's commitment to protecting the health of
Americans and helping people with developmental disabilities reach
their full potential by providing a better understanding of autism and
developmental disabilities.
early learning
Question. We know that investments in early learning offer some of
the highest returns on investment of any Federal support. We also know
that if children learn more now, they'll earn more later.
Unfortunately, despite bipartisan support for these policies that help
children learn and parents go to work, fewer children are receiving
access to child care assistance than at any time in the history of the
Child Care and Development Block Grant. From 2006 to 2015 alone, the
average monthly number of children served fell by 373,100. Do you
commit to providing funding that will allow States to turn around the
precipitous drop in families receiving child care assistance so
children can receive high-quality care that prepares them for bright
futures and parents can go to work knowing their children are well
cared for?
Answer. Current funding levels for CCDBG are the highest in the
history of the program, and the President's Fiscal Year 2018 Budget
Request includes funding to serve about 1.4 million children each
month. HHS is committed to working with States to help leverage
available resources to provide access to child care for the working
families who need it.
Question. There have been policy proposals from within the Trump
administration that suggest privatizing the Corporation for Public
Broadcasting (CPB). The CPB plays a critical role in supporting public
television across Pennsylvania and the Nation. Given the important role
that public broadcasting programming plays in creating high-quality
educational content for young children, do you support privatization of
the CPB?
Answer. I am not aware that the Corporation for Public Broadcasting
(CPB) is within HHS's jurisdiction.
Question. According to the 2013 National Survey of Early Care and
Education, the median wage for center-based early childcare staff was
$9.30 an hour, or about $19,000 a year. This means child care workers
on average make less than parking lot attendants, manicurists, and
massage therapists. One amazingly dedicated worker I met told me she
had to choose between paying for food and her medicine. This problem is
repeated in Head Start as well. We say that children are our most
valuable resource, so we should be paying the individuals who take care
of them accordingly. I believe high quality early learning
opportunities for all children are critical for success later in life--
if children learn more now, they'll earn more later. What will you do
to help increase wages for our child care and early childhood
workforce?
Answer. States have the flexibility to decide how they invest their
CCDBG funds, and are allowed to use those funds to support professional
development and financial assistance for child care workers. HHS is
committed to providing innovative ideas, technical assistance, and
research to States that choose to focus funds on these activities in
order to assist them to better support the child care workforce for the
benefit of the children they serve.
Question. Given the critical need for more access to more high
quality early learning services, how will you work to strengthen and
expand our system of early learning so more children can receive high
quality supports?
Answer. If confirmed, I will work with ACF to support States
through technical assistance and research as they continue to lead the
way on systemic investments in quality improvement and increasing
access to child care for low-income working families.
Question. Early childhood educators--including those working in
publicly funded preschools--are often paid less than their equally
qualified counterparts in K-12 education. Do you believe the pursuit of
compensation parity is important? If yes, how would you support States
to promote and implement policies that support it?
Answer. Every community has different demographic, budgetary, and
policy needs that shape its approach to early childhood education
programs and their workforce. I believe a one-size-fits-all approach is
not feasible for a country as diverse as the United States. If I am
confirmed, I will work with ACF leadership to identify ways that we can
work to support early childhood care providers and educators for the
benefit of the children they serve.
Question. Since its inception, Head Start has served over 32
million children and families, providing our youngest learners with
vital skills they need for a healthy future and strengthening the
parenting skills of parents and guardians. Will you make investments to
support and strengthen Head Start to ensure that low-income students
under the age of 5 are ready to succeed in school and life?
Answer. I share your support for and commitment to the Head Start
program. If confirmed, I will work to ensure that HHS implements the
Head Start statute in an effective and efficient manner so that the
children served by the program are better prepared for success in
school and life.
agency for healthcare research and quality
Question. The Agency for Healthcare Research and Quality (AHRQ) is
the Department's lead agency in generating research evidence to improve
patient safety. Under AHRQ's initiatives over the past 5 years,
hospital-acquired conditions fell by 21 percent, saving 125,000 lives
and $28 billion in health-care costs. Do you support these efforts to
improve patient safety and will you continue to support the agency's
funding requests?
Answer. Efforts to improve patient safety are important. I have not
been privy to budget formulations and cannot speak to AHRQ's funding
request.
maternal and infant health
Question. The Department of Health and Human Services Draft
Strategic Plan for FY 2018-2022 recognizes the importance of increasing
breastfeeding rates and access to breastfeeding support, supplies and
counseling. For example, the Draft Strategic Plan supports increased
access to breastfeeding supports and lactation accommodations;
encourages the practice of breastfeeding to support the healthy
development of children and youth; and encourages breastfeeding to
reduce obesity. If confirmed, what actions will you take to ensure that
the Department of Health and Human Services takes the appropriate steps
to implement the goals set forth in the Draft Strategic Plan?
Answer. I am not familiar with the current programs at HHS related
to breastfeeding, but I know the agency has an important role to play
in developing information based on science and educating the public. I
look forward to supporting these efforts, if confirmed.
Question. There is ample evidence that supports breastfeeding to
improve the health and well-being of children, whenever feasible. If
you are confirmed, you will have broad authority to significantly
change or repeal the regulations that implement the Affordable Care
Act. Will you work with Congress to ensure that any regulatory changes,
including to the breastfeeding preventive services requirement, are
implemented in such a way that mothers will continue to have
uninterrupted and broad access to these important services?
Answer. I believe that all women should have access to quality,
affordable health care and to services they choose that work for them
and that meets their needs.
viral hepatitis elimination
Question. Nearly 5 million Americans are now living with hepatitis
B or C. Infection with hepatitis B and/or C is a leading cause of liver
cancer, the rates of which have steadily increased since 2003. Since
2012, hepatitis C has accounted for more deaths than all 60 of the
reportable infectious diseases combined.
Earlier this year, the Centers for Disease Control and Prevention
(CDC) released an updated estimate of the costs needed to prevent,
treat, and eliminate hepatitis B and C. The CDC's letter to HHS begins
by stating: ``Our Nation is losing ground in the battle against viral
hepatitis--infections of which kill more Americans than all reportable
diseases combined.'' According to the CDC, our government will need to
spend $3.9 billion over the next 10 years to cut the incidence of
hepatitis B and C in half. To achieve this, the CDC recommends
investing $1.7 billion over the next 5 years. Will you, if confirmed as
Secretary of Health and Human Services, commit to following the CDC's
recommendations to eradicate the hepatitis B and C epidemics?
Answer. Viral hepatitis is a serious public health threat to the
Nation. The sharp increases in viral hepatitis incidence can primarily
be attributed to injection drug use associated with the growing opioid
crisis. I know the administration and the Department are fully
committed to addressing this crisis and the resulting increases in
hepatitis B and C. I look forward to working with CDC, if confirmed, to
address this issue.
Last year, the National Academies of Sciences, Engineering, and
Medicine reported that with greater will and resources, our country can
eliminate hepatitis B and C. This spring, the National Academies
released a report detailing the key strategies for how to eliminate
hepatitis B and C. If confirmed as Secretary of Health and Human
Services, do you intend to make the elimination of hepatitis B and C a
major priority, and--if so--what role will the National Academies'
report play in shaping your strategy?
Answer. The rapidly rising rates of viral hepatitis are of great
concern. I look forward to reviewing the National Academies' report and
working with CDC to outline a clear path toward eliminating hepatitis B
and C as a public health threat.
Question. Our country is in the midst of an opioid epidemic. In
2015 alone, more than 30,000 people died from opioid overdose. For the
first time in decades, heroin accounted for more of these deaths than
prescription pain killers. And for the first time in our Nation's
history, more people died from heroin-related causes than from gun
homicides. The opioid epidemic has fueled an outbreak of hepatitis B
and C, and we are also seeing elevated rates of HIV infection. From
2010 to 2014, acute hepatitis C infections increased by 250 percent.
From 2006 to 2013, acute hepatitis B infections increased 114 percent
in three States that have been on the forefront of the opioid overdose
epidemic--Kentucky, Tennessee, and West Virginia. If confirmed as
Secretary of Health and Human Services, what strategies will you use to
address the spike in hepatitis B, hepatitis C and HIV infections caused
by the opioid epidemic?
Answer. Viral hepatitis and HIV infections are a serious public
health threat to the Nation. The sharp increases in viral hepatitis
incidence and new HIV infections can primarily be attributed to
injection drug use associated with the growing opioid crisis. I know
the administration and the Department are fully committed to addressing
this crisis and the resulting increases in hepatitis B and C and new
HIV infections. I look forward to working with CDC and other agencies
within HHS, if confirmed, to address this issue.
Question. Hepatitis B impacts over 2.2 million Americans in the
United States, and prevalence rates are rising. Significant research
investments have been made to ensure that there is a safe and effective
vaccine and clinical interventions. If confirmed as Secretary of Health
and Human Services, how do you plan to continue the efforts toward
eradicating hepatitis B?
Answer. CDC is taking action--and will continue to take action--to
prevent and reduce the incidence, morbidity, and mortality associated
with hepatitis B virus. CDC's viral hepatitis strategic plan for 2016-
2020 (Bringing Together Science and Public-Health Practice for the
Elimination of Viral Hepatitis) outlines the agency's prevention
priorities. The strategies include assuring vaccination, early
detection and response, and screening and linkage to care/treatment. I
am supportive of these efforts and look forward to continuing the work
in this space, if confirmed.
intimate partner violence
Question. Injuries and violence are now the leading cause of death
for Americans ages 1 to 44. Each year, injuries and violence account
for 192,900 American deaths, 3 million hospital admissions, and $671
billion in medical and work loss costs. The National Academies have
recommended a comprehensive Federal injury and violence prevention
agenda. The Centers for Disease Control and Prevention's National
Center for Injury Prevention and Control is tasked with studying
violence and injuries and researching the best ways to prevent them. If
confirmed as Secretary of Health and Human Services, will you continue
to support Federal initiatives to prevent injuries and violence,
including domestic violence and sexual assault?
Answer. Yes.
public health preparedness
Question. During the last reauthorization of the Pandemic and All-
Hazards Preparedness Act, I worked to ensure that our public health
preparedness strategy included an appropriate evaluation of, and
planning for, the medical and mental health needs of children in the
case of a disaster or public health emergency. Children make up 25
percent of the population in the United States and, as we frequently
say in health policy, ``are not little adults.'' Therefore, disaster
planning and response must take their unique anatomic, physiologic, and
developmental/
behavioral characteristics into account in order to be truly prepared.
In light of the recent public health emergencies that have affected
children, from Ebola to Zika, the government can and must do better to
meet the needs of children. The HHS National Advisory Committee on
Children and Disasters has been particularly helpful in providing
advice and recommendations to the Federal Government, and I hope you
will act on these recommendations. How will you ensure that all
communities are prepared to respond to the unique needs of children
before, during and after a disaster? How will you advocate for needed
resources for HHS to address the public health, medical and mental
health needs of children and their parents who have been affected by
disasters, such as the U.S. citizens in Puerto Rico and U.S. Virgin
Islands?
Answer. Children possess unique needs leading up to, during, and
after disasters that require a special focus. Recommendations made from
the National Advisory Committee on Children and Disasters will receive
serious consideration if I am confirmed. The impact on children from
the most recent hurricanes is significant. If confirmed, I will work to
ensure coordination between HHS programs and State officials is meeting
the special needs of children impacted by these storms.
Question. In the last several years, we have seen the emergence of
new strains of pandemic influenza, the first Ebola epidemic and the
emergence of new infectious diseases such as the Zika virus and Middle
Eastern Respiratory Syndrome (MERS), all of which have significantly
taxed State and Federal resources and highlighted gaps in our domestic
and international preparedness. The Ebola and Zika outbreaks illustrate
the ability of infections to spread globally, including spreading
rapidly into the United States. While we have learned that the best way
to protect the United States is to engage with the global community to
strengthen disease surveillance and intervention, this engagement has
not been fully realized. As Secretary of HHS, are you committed to
continued engagement in global health security? How will you make sure
the U.S. Government is sustainably investing in research and
development for new drugs, vaccines, diagnostics and other
interventions so that we are ready to address both existing and
emerging infectious disease threats?
Answer. During my previous time at HHS, I was deeply involved in
global public health coordination activities and efforts to create
sustainable research and development in biomedical countermeasures, and
am committed to ensuring their continued success. The President and his
administration have affirmed their commitment to global health
security, including leveraging mechanisms such as the Global Health
Security Agenda. If confirmed, I look forward to working to further
these critical activities.
Question. If confirmed as Secretary of Health and Human Services,
how will you make sure the U.S. Government is sustainably investing in
research and development for new drugs, vaccines, diagnostics, and
other interventions so that we are prepared to address both existing
and emerging infectious disease threats?
Answer. During my previous tenure at HHS, I was deeply involved in
creating mechanisms to support sustainable investment research and
development for biomedical countermeasures. I look forward to working
with Drs. Kadlec, Fauci, Fitzgerald, and Gottlieb to enhance U.S.
preparedness for infectious disease threats.
Question. If you were to be confirmed as Secretary of Health and
Human Services, how do you envision the Department addressing
biothreats and the regulation of select agents?
Answer. The Biomedical Advanced Research Development Authority
(BARDA), as well as the Project BioShield program increase our ability
to respond to biothreats. Though BARDA has successfully invested in 34
products which have received FDA approval, more work is required to
meet the ever-growing threats. There are still material threats where
no treatment or vaccine currently exists. If confirmed, I will work
with ASPR and BARDA to build on the successes of the program so
Americans are protected from additional threats. I would also work with
CDC, across the Department, and with the Department of Agriculture and
other components of the executive branch to ensure that the HHS select
agents regulations are appropriately implemented and enforced.
Question. The rise of vector-borne diseases coincides with
decreased funds and support for the Centers for Disease Control and
Prevention in this area. If confirmed as Secretary of Health and Human
Services, what are your plans for addressing the rising risk of vector-
borne diseases on the Nation's health and safety?
Answer. Addressing the threat of vector-borne diseases remains an
important priority. The recent Zika epidemic demonstrates the risk
posed by vector-borne diseases. It is critical that we ensure adequate
capacity at the Federal, State, and local levels to detect and respond
to vector-borne threats, as well as develop innovative methods for
preventing vector-borne diseases.
Question. As you know, the Biomedical Advanced Development
Authority (BARDA) is the lead Federal agency that develops and
stockpiles treatments for chemical, biological, radiological, and
nuclear threats. Though it is located within a health-care department,
BARDA's mission is critical to our national security. Most recently,
BARDA has been leading the Department of Health and Human Services'
efforts to successfully develop vaccines for Ebola and Zika. Like all
drug development, it takes years--decades in most cases--to
successfully test a smallpox vaccine or an anthrax treatment. But
medical countermeasure (MCM) development is unlike any other type of
drug or vaccine development because of how complex the clinical testing
and regulatory review processes are. And to make it even more
challenging, the only purchaser of these products is the Federal
Government. Given the important role it plays in protecting America's
national security, what steps will you take, if confirmed as Secretary
of Health and Human Services, to ensure BARDA has the resources it
needs to continue advancing MCM development programs?
Answer. During my previous tenure at HHS, I was a leader in
creating these very systems to enable and support sustainable research
and development of biomedical countermeasures, and I am committed to
ensuring their continued success. BARDA plays an integral role in our
national security. Developing and stockpiling products is costly;
however, the costs pale in comparison to the cost in lives and recovery
if America is attacked with one of these biothreats by a terrorist or
state actor. Since my previous tenure as General Counsel and Deputy
Secretary, I have recognized that, for many of these products, the only
market is government entities. Industry needs confidence that, if they
invest in developing a product that meets one of these government
needs, the government will be willing to stockpile it. If confirmed,
I'm committed to building on the success BARDA and Project BioShield
have seen since their inception.
Question. In 2013 Congress reauthorized $2.8 billion in funding for
Project BioShield's Special Reserve Fund (SRF). For over a decade, the
SRF has created a market for biodefense medical countermeasures and
signaled the government's commitment to procure MCMs against national
security threats. Each year, SRF funds are used to stockpile millions
of doses of drugs and vaccines against threats like anthrax, smallpox,
nuclear radiation. Unfortunately, to date, only $1.5 billion has been
allocated to this critical fund. Without a renewed commitment to the
SRF from the Secretary of Health and Human Services (HHS), we risk the
delay or cancellation of critical MCM procurements. Can you please
describe what actions you will take, if confirmed as Secretary, to
renew HHS's commitment to fully funding the SRF, as Congress intended?
Answer. I am committed to build on the successes of BARDA and
Project BioShield. If confirmed, I look forward to gaining additional
information on the current state of the SRF and will work with the
programs and Congress to address the financial needs of the program.
national institutes of health
Question. For decades, the United States has led the world in
biomedical research. In Pennsylvania alone, we have thousands of world-
class researchers who rely on funding from the National Institutes of
Health to lead discovery and develop new treatments. Yet Federal
funding for the NIH hasn't kept pace with inflation in the last 10 to
15 years, and we're losing ground to other countries who are increasing
their investment in scientific research. The 21st Century Cures Act
made an important investment in the Cancer Moonshot, the Precision
Medicine Initiative and the BRAIN Initiative, but if we truly want to
lead the world in medical innovation, we need to invest more in
scientific research that leads to discoveries and new cures. If
confirmed, will you commit to maintaining the United States' position
as a world leader by advocating for funding the NIH at a level
consistent with medical inflation?
Answer. NIH is the world leader in biomedical research, and I will
do everything in my power to maintain this tradition.
Question. Thirty million Americans live with rare diseases, while
treatment innovation and clinical expertise have stagnated. If
confirmed, what efforts would you undertake as Secretary of Health and
Human Services to improve scientific discovery and clinical management
of rare diseases?
Answer. Having worked at HHS previously, I know the department is
committed to working both across and within agencies to accelerate
efforts to improve scientific discovery and clinical management of rare
diseases. Collaboration across agencies is very important to assuring
that advances leading to treatments in rare diseases are managed
expeditiously to benefit the American taxpayer. I am committed, if
confirmed, to ensuring that staff are supported to achieve advances in
scientific discovery.
food and drug administration
Question. If confirmed as Secretary of Health and Human Services,
what strategies would you advocate to collect and share data on the
safety of medical devices with the American public, so that doctors and
patients can make informed decisions?
Answer. The FDA under Commissioner Gottlieb has taken several
steps, including the NEST system, to make this information available to
consumers. If confirmed, I would support the work of Dr. Gottlieb and
the career scientists at the agency.
Question. What are your opinions on current Food and Drug
Administration (FDA) policies on direct-to-consumer advertising of
prescription drugs? If confirmed as Secretary of Health and Human
Services, what guidance will you give to the FDA to assure that
patients have accurate information on the safety and efficacy of
prescription drugs?
Answer. I believe it is important to protect patients from false or
misleading information and protect the integrity of the drug approval
process in a manner that is consistent with the First Amendment, and
that furthers the interest in ensuring that payers, practitioners, and
patients have access to truthful and non-misleading information that
may help them to make informed decisions. I support this goal and, if
confirmed, look forward to being briefed on the agency's efforts.
Question. In April 2016 the FDA proposed a rule (81 FR 24385)
banning electronic devices that shock students or residents in schools
or residential facilities. Thousands of comments were submitted in
support of the rule but the FDA has not yet banned such devices. Do you
support the use of such aversive devices for the purposes of discipline
and control of children and individuals with disabilities? Will you
support a ban of such devices if confirmed as Secretary?
Answer. If confirmed, I look forward to being briefed on this issue
by the agency leadership and subject matter experts.
Question. Forty-eight million Americans get sick every year from
foodborne illness and 3,000 die. Prevention measures, like those in the
Food Safety Modernization Act (FSMA), are essential, particularly for
vulnerable citizens like children and the elderly. Do you think that it
is important to keep food safe and protected, particularly from
intentional adulteration and terrorism? Are you committed to preserving
these protections?
Answer. Yes, FDA's role in protecting our Nation's food supply is a
vital part of fulfilling FDA's public health mission and, if confirmed,
I will support their work, including implementation of FSMA.
Question. On October 2, 2017, the FDA issued a proposed rule to
extend the compliance date for the final rules to update the Nutrition
Facts Label. The proposed rule extended the compliance date from July
26, 2018 to January 1, 2020 for manufacturers with $10 million or more
in annual sales, and extended the date from July 26, 2019 to January 1,
2021 for manufacturers with less than $10 million in annual food sales.
Many companies have already invested to meet these requirements. Are
you committed to implementing the updates to the Nutrition Facts Label
without further delays?
Answer. As someone who suffers from two medical conditions
requiring accurate nutrition labeling and close scrutiny of those
labels, this is an issue near to my heart. I personally want to ensure
that as much as is reasonably possible, individuals have the
information they need to make healthy and safe choices regarding their
food consumption and companies are not unduly burdened by requirements
or uncertainty. If confirmed, I look forward to supporting a successful
implementation of the nutrition fact labeling updates.
Question. Do you support the ``added sugars'' line on the revised
Nutrition Facts Label so Americans can know how much added sugar is in
a food product? In addition, are you committed to releasing a final
guidance for added sugars to provide clarity to industry?
Answer. I recognize the importance of consumers being empowered in
their food choices. I also appreciate that guidance can be an important
tool for helping industry implement regulatory requirements and
providing insights into FDA's regulatory decision making. If confirmed,
I look forward to being briefed on ``added sugars'' and any regulatory
considerations by the FDA.
Question. Given the proposed rule on the Nutrition Facts Panel,
manufacturers will likely be required to use the new Nutrition Facts
Panel by January 2020 or January 2021. In addition, the United States
Department of Agriculture (USDA) is in the process of establishing a
label for products that contain genetically engineered ingredients.
This rulemaking is expected in July 2018, with 2 years for compliance.
For products that contain genetically engineered ingredients,
manufacturers must update their labels to comply with the nutrition
facts panel changes, and subsequently update their labels to disclose
genetically engineered ingredients. If confirmed as Secretary of Health
and Human Services, how will you work collaboratively with other
agencies, such as USDA, to provide support to manufacturers in order to
ensure that manufacturers can comply with these deadlines?
Answer. I support the goal of better dialogue and coordination with
leaders and public servants in other departments and agencies to ensure
that we are working toward our shared objectives in an efficient manner
that avoids placing unnecessary burdens on regulated entities. If
confirmed, I look forward to engaging in a sustained dialogue with my
counterparts, including the Secretary of Agriculture, in order to
advance this goal.
Question. Poor nutrition is a significant public health problem in
the United States. Americans are eating too many calories and too much
sugar, sodium and saturated fat. This has led to significant increases
in the number of Americans who are overweight or obese and at risk for
cardiovascular disease, cancer, diabetes, and other chronic health
conditions. This results in significant costs to the health-care
system, employers, and Americans themselves. A poor diet is also the
leading cause of death among modifiable risk factors, which means
behaviors can be changed to decrease the risk and help people make
healthier choices. The Department of Health and Human Services has a
long tradition of addressing these issues with the Dietary Guidelines
for Americans, and the Food and Drug Administration provides critical
guidance through nutrition labeling, menu labeling, and encouraging
healthful changes to the food supply. What do you see as the agency's
role in improving diet quality--and the overall health of Americans--
moving forward?
Answer. Providing consumers with tools to make healthy lifestyle
choices, including choices about the foods they eat, can have a
significant and positive impact on reducing health-care costs. If
confirmed, I look forward to working with FDA leadership on policies to
better promote the use of nutritional information as a way to prevent
disease and death without unnecessarily burdening food producers,
retailers, and restaurant owners. I would also like to add to these
efforts a consideration of the latest evidence-based behavioral
economics learnings regarding how people make choices, why they make
those choices, and what interventions can assist them in that decision-
making, that might aid HHS in its work in this area.
Question. As import volumes continue to grow, the Food and Drug
Administration (FDA) will need additional funding to keep up with this
increasing volume. If confirmed as Secretary of Health and Human
Services, will you commit to working to ensure that FDA has the
resources it needs to create a truly level playing field on behalf of
domestic food producers, and will you seek the funds necessary to
advance this initiative in President Trump's Fiscal Year 2019 budget?
Answer. I recognize the importance of consumers being empowered in
their food choices. I also appreciate that guidance can be an important
tool for helping industry implement regulatory requirements and
providing insights into FDA's regulatory decision making. If confirmed,
I look forward to being briefed on this issue and on funding levels.
Question. In December, the FDA announced that it would delay the
compliance deadline for regulations pertaining to certain tobacco
products. If confirmed as HHS secretary, how would you approach the
regulation of the different types of tobacco products covered under the
deeming regulation? Would you seek to change any of these regulations
before they take effect, and if so, what factors would guide your
vision for tobacco regulation?
Answer. Commissioner Gottlieb has recently announced a bold and
balanced approach to tobacco and nicotine regulation at FDA, including
key efforts to prevent youth and adolescents from initiating tobacco
use. If confirmed, I look forward to partnering with Commissioner
Gottlieb in the implementation of a science- and evidence-based
framework to regulating tobacco products. The direction laid out over
the past 12 months by the Commissioner is one that, if fully
implemented, will drastically reduce the potential for youth addiction
to cigarettes, and result in millions of individuals living longer,
healthier lives by beating the scourge of addiction that afflicts so
many today. This proposal is vital to our mission of saving lives; with
your support, we will strive to one day see the end of addictive
cigarettes, something which was viewed as impossible in the not-so-
distant past.
rural health
Question. If confirmed as Secretary of Health and Human Services,
what strategies would you implement to reduce regulatory barriers to
deliver telehealth services to Americans who reside in rural areas?
Answer. It is my understanding that CMS is reviewing their existing
regulations and taking steps to evaluate and streamline regulations
with a goal to reduce unnecessary burden, increase efficiencies, and
improve the beneficiary experience through their Patients over
Paperwork initiative. If confirmed, I will work with CMS to make sure
their programs achieve a balance between protecting patient safety and
avoiding undue burden on providers. I also understand that CMS recently
sought information regarding ways that it might further expand access
to telehealth services within the current statutory authority and pay
appropriately for services that take full advantage of communication
technologies. CMS is likely carefully reviewing comments and
considering commenters' suggestions for future rulemaking and any
appropriate sub-regulatory changes. If confirmed, I look forward to
hearing ideas from Congress and other stakeholders on how CMS can
improve access to services, including telehealth services, to make sure
beneficiaries in rural areas have access to high-quality care that
meets their needs.
grandfamilies and caregivers
Question. There are an estimated 2.6 million children being raised
in grandfamilies, a term used to describe families where grandparents
are the primary caregiver for grandchildren or other relatives are
caring for relative children. Though grandfamilies are not new, experts
believe that the opioid epidemic is contributing to the rise in the
number of grandfamilies. When parents are unable to care for their
children due to their addiction, many grandparents and other relatives
step in. Relatives who keep children out of the foster care system save
taxpayers over $4 billion dollars each year. This role may be sudden
and unexpected, however, and can dramatically alter the caretaker's
life, significantly affecting their financial stability and health,
among other things.
After hearing from experts and grandfamilies about this issue,
Senator Susan Collins and I introduced the Supporting Grandparents
Raising Grandchildren Act. This bill will create a Federal Task Force,
including Federal agencies like SAMHSA, to serve as a ``one-stop shop''
of resources and information for grandparents raising grandchildren.
This bipartisan legislation is supported by many outside groups,
including Generations United, AARP and the American Association of
Pediatrics.
How do you think improved coordination and collaboration across the
government and with experts will help these grandparents and relatives?
Given the support for this bill, we are confident that it will pass
and be signed into law in the near future. If confirmed, will you
commit to ensuring the collaboration and coordination required in this
bill is a priority?
Answer. With the opioid crisis, supporting grandparents and
relatives who act as primary caretakers in their families is an
emergent need and one that SAMHSA is committed to addressing in its
programs and policy initiatives. With the Administration on Community
Living, SAMHSA is collaborating internally to ensure complementary
efforts. However, older adults raising children and youth have concerns
that affect all areas of their family lives: education, history,
transportation, primary health care, behavioral health care, financial
stability, and for some, juvenile justice. Working together with our
Federal partners, including the Department of Education, Department of
Justice, and the Department of Housing and Urban Development, we can
ensure that any programs and policy initiatives address the full range
of needs grandparents and relatives may have. Close coordination will
ensure all efforts leverage the full range of resources across the
Federal Government, are non-duplicative, and financially efficient. I
am committed to implementing the laws passed by Congress, and would
coordinate with the appropriate agencies across the Federal Government
as needed.
older americans
Question. As Americans age, they are often confronted with greater
health-care needs. Historically, seniors paid up to 11 times higher
premiums for health insurance than non-seniors. Medicare was
established to provide older adults, ages 65 and older, with more
affordable health insurance coverage than routinely available by
private insurers. Prior to the Affordable Care Act (ACA), only nine
States limited private insurance premiums for older adults; the ACA
limited premium surcharges to three times the rate of non-seniors, and
the ACA has proven to be vitally important to older adults not yet
eligible for Medicare; 3.3 million people ages 50 to 64 are enrolled in
the ACA Marketplaces--representing the largest share of enrollees
nationwide (26 percent). Do you believe that insurance companies should
be able to charge older Americans seeking coverage on the individual
market more for their health insurance than younger Americans? If so,
how much more? And, why?
Answer. There is an emerging bipartisan consensus that the ACA's
structure is fundamentally flawed in this area. The age rating
structure as currently in statute does not allow for functional risk
pooling. Under the ACA age rating requirements, insurance is
unaffordable for younger and healthier individuals. That is why older
enrollees currently represent the largest share of enrollees. As a
result, premiums have risen for older Americans far beyond anything
that would have occurred in a stable risk pool even with more realistic
age rating structure. This is a problem we must all work together to
solve, as effective and predictable risk pools are critical to the
success of any health insurance system. If confirmed I pledge to work
with Congress on health-care reforms that create effective risk pools.
Question. Last year, with bicameral, bipartisan support, Congress
unanimously approved and the President signed into law the Older
Americans Act Reauthorization Act of 2016. If confirmed as Secretary of
Health and Human Services, would you continue to protect and enhance
OAA programs such as Meals on Wheels, senior centers, transportation,
employment and training services for the growing number of seniors in
social and economic need?
Answer. If confirmed, I will work with the Administration for
Community Living to advocate for and enhance OAA programs within the
budgetary constraints of the current fiscal environment. Also, I
believe that the use of innovation and evidence-based practices will be
critical to meeting the evolving needs of older Americans and those
with disabilities.
Question. Older Americans Act (OAA) Nutrition Programs are serving
23 million fewer meals \13\ than in 2005 due to limited funding, while
the number of seniors experiencing hunger increased by 73 percent from
2007 to 2014. In addition, a recent GAO report \14\ found that about 83
percent of food insecure seniors and 83 percent of physically impaired
seniors did not receive meals through the OAA but likely needed them.
If confirmed as Secretary of Health and Human Services, would you
increase funding for programs that support nutritionally at risk,
vulnerable seniors?
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\13\ https://www.acl.gov/programs/health-wellness/nutrition-
services.
\14\ http://www.gao.gov/products/GAO-15-601R.
Answer. The OAA nutrition programs offered through the
Administration for Community Living help meet the needs of many of the
Nation's older adults. The programs not only provide health-promoting
meals in a variety of group settings, such as senior centers, and
faith-based settings, as well as in the homes of isolated older adults,
but also provide an important link for the individuals served to other
supportive community-based services. If confirmed, I will work with the
Administration for Community Living to ensure their continued effective
and efficient implementation through the use of innovation and
evidence-based practices, including through the flexibility Congress
provided to allow up to 1 percent of ACL's nutrition funding for
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exploring innovative ways to provide these services.
Question. The State Health Insurance Assistance Programs (SHIPS)
are the only source of one-on-one Medicare counseling for seniors and
people with disabilities. In 2015, over 7 million people with Medicare
received help from SHIPs. Since 1992, counseling services have been
provided via telephone, one-on-one in-person sessions, interactive
presentation events, health fairs, exhibits, and enrollment events, and
individualized assistance provided by SHIPs almost tripled over the
past 10 years. This modest program is operated in every State and U.S.
territory and has been significantly underfunded for years on end
despite the growing need, as 10,000 Baby Boomers become Medicare
eligible each day. As HHS Secretary, you would oversee the
administration of this program through the Administration on Community
Living. This administration has recommended eliminating the $52 million
in annual funding that allows SHIP programs to support older adults and
people with disabilities with Medicare decision-making. Will you
protect the SHIP program and ensure its continued funding?
Answer. For older adults, people with disabilities, and their
families, identifying what services and supports are available,
understanding how to access them, and navigating the systems that
provide them can be overwhelming. If confirmed, I look forward to
working with all parties to ensure that older adults, people with
disabilities, and their families understand the choices and services
available to them and how to access them.
Question. As the Ranking Member of the Senate Committee on Aging, I
have a significant concern about the financial security of our Nation's
older adults. Not only must they decide the best way to spend during
their golden years but must also make sure they are protecting their
nest eggs from fraud and abuse. It has been estimated that financial
abuse targeting seniors adds up to nearly $3 billion annually. Once
seniors lose money in this way, we've heard they almost never receive
ample payback for their loss. This can significantly affect a person's
entire life, including their health. If confirmed, how would you help
to ensure that older adults are aware of the prevalence of financial
abuse and the effect it could have on their lives, including their
health?
Answer. HHS through the Administration for Community Living has
long been engaged in efforts to protect older individuals from elder
abuse including financial exploitation, physical abuse, neglect,
psychological abuse, and sexual abuse. Through the Elder Justice Act of
2009, the Elder Justice Coordinating Council was developed, which is
led by the Secretary of Health and Human Services and the Attorney
General of the United States and includes the heads of 10 other Federal
agencies that administer programs related to abuse, neglect, or
financial exploitation as council members. If confirmed, I will
continue to support these efforts.
Question. In July 2017, the Special Committee on Aging held a
hearing highlighting food insecurity, the importance of proper
nutrition on senior health, and the role federally funded nutrition
programs play in seniors' access to nutritious foods. At this hearing,
Pat Taylor of Penn Hills, Pennsylvania testified on the importance of
federally funded senior nutrition programs and stated that awareness of
and ease of access to federally funded programs is critical to older
adults participating in these programs. Because of Pat, and others like
her, I have introduced S. 2085, the Nourishing Our Golden Years Act.
This bill will set a minimum certification period for the U.S.
Department of Agriculture's Senior Food Box Program and provide States
with the flexibility to extend the certification period beyond the
minimum. This flexibility will reduce burden on State administering
agencies as well as seniors.
Answer. If confirmed, I will continue to support the value of these
vital nutrition programs for older adults.
Question. The Administration on Aging also oversees two federally
funded nutrition programs that are critical to the health and well-
being of older Americans, the Congregate Meal Program and the Home-
Delivered Meal Program. These programs are uniquely different from
those administered by the USDA and I know first-hand the importance of
congregate and home delivered meals for older Pennsylvanians. If
confirmed, will you commit to supporting the Congregate Meal and Home-
Delivered Meal programs?
Answer. If confirmed, I will continue to support the value of these
vital nutrition programs for older adults.
Question. According to the Administration for Community Living,
almost half of older adults in the United States are malnourished.
Malnutrition occurs among people who are underweight as well as
overweight and there is a growing field of research that indicates
older Americans are at increased risk of hunger and malnutrition.
Poverty and food insecurity significantly increase the risk of
malnutrition, however, changes with age also contribute to this risk.
Nearly 60 percent of hospitalized older adults and 35 percent to 50
percent of older adults in long-term care facilities are malnourished.
Of hospitalized older adults, an estimated 20 percent had an average
nutrient intake of less than 50 percent of their calories needed to
maintain their weight. The annual cost of disease-associated
malnutrition among older adults has been estimated to reach $51.3
billion. For this reason, early nutrition interventions, including
screening for malnutrition and access to nutrition assistance programs,
continue to be important for the growing number of older Americans.
Malnutrition screening, assessment, and intervention has been shown to
decrease negative health outcomes including readmission and mortality.
If you are confirmed, how will HHS integrate malnutrition screening
into health and nutrition programs?
Answer. If confirmed, I will work with the Administration for
Community Living and the USDA to continue to support the implementation
of the vital nutrition programs they administer and seek new approaches
for the integration of their nutrition screening, assessment, and
intervention programs and guidelines.
teaching health center graduate medical education (thcgme)
Question. The Teaching Health Center Graduate Medical Education
(THCGME) program, currently administered by the Health Resources and
Services Administration (HRSA), provides funding to increase the number
of primary care medical and dental residents training in community-
based settings across the country. As most health care in the U.S. now
takes place in the outpatient setting, the ultimate goal of the THCGME
program is to increase access to well-trained providers, particularly
in ambulatory settings, for people who are geographically isolated and
economically or medically vulnerable. In 2014, a report of the
Institute of Medicine (now National Academy of Medicine) noted that the
long term prospects of the program are uncertain without some assurance
of future funding. Evidence proves that family medicine resident
physicians who train in Health Center (HC) settings are nearly three
times as likely to practice in underserved settings after graduation
when compared to residents who did not train in HCs. If confirmed as
Secretary of Health and Human Services, you would play a role in
helping manage health workforce programs and addressing our Nation's
physician workforce shortage and distribution challenges. What is your
perspective about the value of the THCGME program and its role in
supporting high quality primary care physician training in rural areas
and for those who are economically and medically vulnerable? If
confirmed, would you work with Congress to support the program?
Answer. The THCGME program aims to bolster the primary care
workforce through support for new and expanded primary care and dental
residency programs, as well as to improve the distribution of this
workforce into needed areas through emphasis on underserved communities
and populations. I support the goals of this program, and, if
confirmed, would work with Congress on approaches to further these
goals.
drug pricing
Question. As innovative new drugs are coming to market, often with
significant price tags, many drug companies and payers are exploring
outcome- or value-based payment models as a way to manage the costs of
these drugs, which can be life-saving or life-changing. In some cases,
they can improve an individual's health or quality of life so
significantly that the individual could incur significantly lower costs
for health care and social services for years or even decades to come--
but the initial payer may not benefit from those reduced costs. How
will you, if confirmed, continue encouraging the development of
outcome- and value-based payment models?
Answer. You raise a very important issue in our payment and
reimbursement system, one that is particularly implicated in the case
of expensive curative therapies. If confirmed, I will work with
Administrator Verma, CMMI, and other parts of HHS and the U.S.
Government to try to find solutions to the challenge of how therapies
may be paid for by one plan when the benefit accrues to another plan
years down the road.
title x funding
Question. Typically the funding announcement for title X grants
comes out well in advance of the application deadline, which is now
March 2018 for all title X programs. Given the tight time frame and
that there has not yet been any funding announcement made, if
confirmed, will you commit to immediately releasing a funding
announcement so that interested parties have sufficient time to prepare
their applications?
Answer. If confirmed, I look forward to learning about the current
status of the FOA and discussing its status further with you.
----------------------------------
[1] The New York Times, https://www.nytimes.com/2016/12/25/opinion/the-
quiet-war-on-medicaid.html.
[2] T.E. Price, 1995, ``Why Managed Care Won't Last,'' The Journal of
the Medical Association of Georgia, 84, p. 165.
[3] ``Behavioral Health Trends in the United States: Results from the
2014 National Survey on Drug Use and Health,'' https://www.samhsa.gov/
data/sites/default/files/NSDUH-FRR1-2014/NSDUH-FRR1-2014.pdf.
[4] ``Increase in Drug and Opioid-Involved Overdose Deaths--United
States, 2010-2015,'' https://www.cdc.gov/mmwr/volumes/65/wr/
mm655051e1.htm.
[5] National Survey on Drug Use and Health, https://www.drugabuse.gov/
publications/drugfacts/nationwide-trends.
______
Questions Submitted by Hon. Mark R. Warner
Question. Historically, the focus in health-care cybersecurity has
been on patient records and privacy. Recent events, however, have
highlighted the increasing cybersecurity importance of patient safety
and ensuring the availability/continuity of critical patient care
delivery. How would you address these newer emerging challenges?
Answer. The safety of American citizens should always be a top
priority of the Department. If confirmed, I will ensure that HHS will
continue its efforts to strengthen cybersecurity within the health-care
industry.
Question. We have seen a steady trickle of stories about hospitals
being hit by ransomware and we know that many of types of ransomware
(along with other malware strains) can impact medical devices. Do you
have any plans to strengthen HHS' guidance or requirements to health
delivery organizations (HDOs) on how they secure their devices?
Answer. As I mentioned above, the safety of American citizens
should always be a top priority of the Department. Ensuring the
security of medical devices against the threat of cyber-attacks,
including ransomware and hacking, is critical to that end. If I am
confirmed, the FDA and the rest of HHS will continue to improve upon
its efforts to strengthen cybersecurity within the medical device
industry as well as other related industries.
Question. Last summer, the Healthcare Industry Cybersecurity Task
Force issued its report to Congress. Which recommendations do you feel
would have the greatest impact and why? Are there any recommendations
you feel would not be a good idea? If so, please provide a rationale.
Answer. As you know, the Health Care Industry Cybersecurity (HCIC)
Task Force, a Federal advisory committee established pursuant to the
Cybersecurity Act of 2015, was charged with making recommendations to
address the challenges the health-care industry faces when securing and
protecting itself against cybersecurity incidents. If confirmed, I look
forward to working with Department leaders to learn more about the
recommendations contained in the Task Force's report and how they
recommend that HHS respond to the recommendations directed toward it. I
will be committed to working across the administration, within the
Department and with HHS's private sector partners and stakeholders to
help combat cybersecurity threats in the health-care industry, if
confirmed as HHS Secretary.
Question. There has been some discussion about whether the
Department of Homeland Security's NCCIC can sufficiently address health
care related cybersecurity issues, or if an HHS-specific HCCIC would
complement this function with greater domain expertise and nuance. What
is your perspective on this?
Answer. If confirmed, I look forward to working with Department
leaders to learn more about the HCCIC and its interaction with the
NCCIC. If confirmed, I will be committed to advancing the Department's
efforts to strengthen and enhance the cybersecurity of the health-care
industry, in coordination with DHS.
Question. How can one find out how much HHS spends on its
cybersecurity? Is it possible to point to one part of the budget to
know if HHS is adequately investing in its cyber hygiene?
Answer. If confirmed, I look forward to working with you and other
members of the Senate Budget Committee on HHS's budget--and will work
within the Department and with the Office of Management and Budget
(OMB) to ensure HHS has adequate resources to address cybersecurity
threats.
Question. Despite a global ransomware outbreak that impacted
hospitals worldwide last year, the President's FY 2018 budget proposed
to cut the Office of the National Coordinator for Health Information
Technology's budget by 37 percent--despite it being the key division
within the Department of Health and Human Services developing resources
and risk management tools for cybersecurity in the health-care sector.
The budget also proposed cutting the Office of Civil Rights at HHS--the
division responsible for overseeing HIPPA privacy and security
compliance--by 15 percent. Do you believe these proposals improve our
Nation's cybersecurity posture?
Answer. If confirmed, I will work within the Department and with
the Office of Management and Budget (OMB) to ensure HHS has adequate
resources to address cybersecurity threats in the health care sector.
______
Question Submitted by Hon. Claire McCaskill
Question. Please describe what role, if any, you believe the
Department of Health and Human Services has with respect to oversight
of inappropriate prescribing practices within Medicare Part D. What
steps will you take to ensure that HHS has the information it needs to
properly exercise oversight in this space.
Please describe your plan for addressing rising instances in
workplace violence within the health-care sector. What goals will you
put in place over the next year to address this issue?
Do you believe that there is currently sufficient transparency on
pharmaceutical company research and development costs? Do you believe
there is sufficient transparency with respect to drug cost generally?
If not, what steps will you take to increase transparency?
Answer. I am generally in favor of increased transparency within
our health-care system. However, the goal of transparency is ultimately
to create more competition and lower drug prices, so we need to make
sure transparency is not counter-productive to that goal. I would be
very happy to study the issue more and work with you to ensure that all
options are evaluated as we think about this important issue, and to
help make sure that our policies related to transparency will actually
lower costs and reduce what patients pay out of pocket.
______
Submitted by Hon. Chuck Grassley, a U.S. Senator From Iowa
United States Senate
WASHINGTON, DC 20510
November 2, 2017
The Honorable Eric D. Hargan
Acting Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Washington, DC 20201
Dear Acting Secretary Hargan:
We are writing to thank you for your support for the Center for
Medicare and Medicaid Services' Center for Program Integrity (CPI). CPI
plays a critical role in conducting oversight, combatting fraud, and
determining best practices within the Medicare and Medicaid programs.
As part of your ongoing commitment to the mission of CPI, we encourage
you to continue to prioritize funding and administration of the Open
Payments database.
The bipartisan Physician Payments Sunshine Act (Sunshine Act)
created the Open Payments database for drug and device company payments
to doctors, which provide transparency on billions of dollars in gifts
and payments from manufacturers to prescribers and hospitals. In doing
so, the database helps patients evaluate the medical advice they are
being given and better understand whether there is the potential for
conflicts of interest. The need for this legislation became apparent
after congressional oversight and several news reports explored
industry payments to doctors, some of which potentially having undue
influence over physician prescribing habits.\1\
---------------------------------------------------------------------------
\1\ Ornstein, Charles, ``Doctors Prescribe More Generics When Drug
Reps Are Kept at Bay,'' NPR, May 2, 2017, www.npr.org/sections/health-
shots/2017/05/02/526558565/doctors-prescribe-more-generics-when-drug-
reps-are-kept-at-bay?sc=tw.
Recent reports have raised concerns about the effect payments to
health professionals may have on opioid prescribing practices, which in
many ways has exacerbated this ongoing public health epidemic. Pending
litigation against a fentanyl manufacturer has revealed instances of
regular weekly contact with high-volume prescribers, in addition to a
large number of total payments.\2\
---------------------------------------------------------------------------
\2\ Stephen Stirling and Erin Petenko, NJ Advance Media for NJ.com,
``Doctors Raked in Cash to Push Fentanyl as N.J. Death Rate Exploded,''
July 3, 2017, www.nj.com/healthfit/index.ssf/2017/06/
doctors_raked_in_cash_to_push_powerful_fentanyl_as_nj_death_rate_soared.
html.
Since the Open Payments database was launched in 2014, it has
reported nearly $25 billion in total payments that drug and device
manufacturers make to physicians and teaching hospitals. Studies have
shown that such payments can have an effect on doctors' prescribing
habits--for example, whether they prescribe a name-brand drug or its
generic alternative. The Sunshine Act does not penalize relationships
between drug and device companies and doctors, and does not prohibit
transfers of value from drug and device companies to doctors. It simply
requires that those transfers be reported and made publicly available,
increasing transparency and informing patients as they make health care
---------------------------------------------------------------------------
decisions.
Many relationships between academic medicine and industry are
necessary and beneficial. During program year 2016, there were 11.96
million total records attributable to 631,000 physicians and 1,146
teaching hospitals. Health care industry manufacturers reported $8.18
billion in payments and ownership and investment interests to
physicians and teaching hospitals. However, some financial
relationships influence prescribing and drive up costs. The Sunshine
Act has substantially improved our ability to determine whether and how
industry is able to influence physicians through payments--for example,
whether they choose to prescribe brand drugs or less expensive generic
alternatives.
The Open Payments database enjoys wide industry and public interest
group support, from members of the drug and device industry as well as
key non-profit stakeholders including the Pew Charitable Trusts, AARP,
and Consumers Union. We thank you for your demonstrated commitment to
CPI, and encourage you to continue to prioritize the timely collection
and disclosure of data within the Open Payments database that has made
the Sunshine Act a success.
Charles E. Grassley Richard Blumenthal
U.S. Senate U.S. Senate
______
The University of Iowa
Injury Prevention Research Center
Prescription opioid and heroin overdoses in Iowa: A growing crisis
March 2017
The University of Iowa Injury Prevention Research Center (UI IPRC) is
conducting research on prescription opioid pain reliever (OPR) and
illicit opioid (heroin) overdoses and overdose deaths in Iowa using
Iowa's death certificate records (2002-2014) and insurance claims data
(2003-2014). IPRC is also engaging with stakeholders in Iowa to help
identify priorities to address this growing crisis in the state.
Key Findings
The rate of OPR overdoses in Iowa increased from 2.1/100,000
in 2003 to 8.8/100,000 in 2009. This rate declined to 5.1/100,000 in
2014.
In Iowa, OPR overdoses and overdose deaths are decreasing,
while heroin overdoses and overdose deaths are increasing.
Those ages 25 to 49 make up the majority of all opioid-
involved overdose deaths in Iowa. Males make up the majority of deaths
from both prescription opioids and heroin.
Prescription opioid use has reached unprecedented levels.
Prescription drug overdose deaths have been rising since the early
1990s, and in 2009 surpassed transportation-related events as the
leading cause of injury death in the United States. OPRs are primarily
driving the increase in these deaths. Since 1999, deaths due to OPRs
have more than tripled in the United States. In Iowa, while OPR
overdose deaths and rates of opioid prescribing are low compared to
other states, rates of prescription drug deaths since 1999 have
quadrupled, making it only one of four states with such a dramatic
increase.
Heroin use is a rapidly growing public health problem and is associated
with non-medical use of prescription opioid pain relievers.
It is suggested that while policies like the Prescription Monitoring
Program (PMP) and physician education may be effective in reducing
imprudent prescribing, they are not allowing patients to obtain
prescriptions from multiple prescribers. As a result, patients who are
OPR dependents or abusers may switch from OPRs to heroin since it is a
cheaper alternative that is more easily available.
Heroin overdose death rates in Iowa have increased more than nine-fold
in the past 15 years.
The rapid growth of heroin death rates in Iowa is two to three times
higher than the national average. Like elsewhere in the nation, the
rates in Iowa were highest in 2008-2009 when state and local agencies
started acting on the prescription OPR abuse epidemic. In 2009, the
state of Iowa implemented its PMP, and in 2011, the Iowa Board of
Medicine implemented a mandatory continuing medical education licensure
requirement for physicians who provide chronic pain management and end-
of-life-care.
UI IPRC Research:
OPR overdoses decreasing; heroin overdoses increasing.
The rate of OPR overdoses in Iowa increased from 2.1/100,000 insured
person-years in 2003 to 8.8/100,000 insured person-years in 2009. In
2009, the PMP was implemented in Iowa, after which the rate of OPR
overdoses declined to 5.1/100,000 insured person-years in 2014. The
data on heroin overdoses show that the rate of heroin overdoses in 2009
was 0.16/100,000 insured person-years, which increased to 1.5/100,000
insured person-years in 2014.
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
OPR overdose deaths decreasing; heroin overdose deaths increasing.
These findings suggest that Iowa is experiencing trends observed
nationally, where OPR overdoses are decreasing while heroin overdoses
are increasing. Using Iowa death certificate records, we see a similar
trend in OPR overdose deaths and illicit opioid overdose deaths.
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Those ages 25-49 make up the majority of opioid-involved overdose
deaths.
Those ages 25-49 make up the majority of opioid-involved deaths,
followed by ages 50 and over. Males make up the majority of deaths from
both prescription opioids and heroin.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Outreach: UI IPRC is engaging stakeholders in Iowa on the opioid crisis
The UI IPRC is participating in a national project funded by the
Centers for Disease Control and Prevention (CDC) to make
recommendations about preventing prescription opioid overdoses. It is
one of four injury control centers in the United States to take part in
an information sharing network to address this issue. Led by the John
Hopkins Center for Injury Research (JHCIRP), each center will promote
evidence-based strategies for reducing the opioid epidemic in their
state in six areas: prescription monitoring programs, prescribing
guidelines, pharmacy benefit managers, overdose education/Naloxone
distribution, addiction treatment and community based prevention. The
UI IPRC will seek input from stakeholders in Iowa via a stakeholder
meeting to create a report that reflects Iowa's priorities, and its
results will be disseminated to leaders and policy makers in Iowa.
Visit our website: www.uiiprc.org.
For more information, contact [email protected].
______
United States Senate
committee on the judiciary
washington, dc 20510-6275
January 4, 2017
The Honorable Andrew M. Slavitt
Acting Administrator
Centers for Medicare and Medicaid Services
200 Independence Ave, SW
Washington, DC 20201
Dear Mr. Slavitt,
Recently, my staff communicated with the office of the Health and
Human Services Inspector General (HHS IG) regarding a report from July
2009 entitled ``Accuracy of Drug Categorizations for Medicaid
Rebates.'' As noted in the report, manufacturers must provide the
Centers for Medicare and Medicaid Services (CMS) with the average
manufacturer price (AMP) by national drug code (NOC) for each of their
covered outpatient drugs.\1\ The report detailed a number of drugs that
the Inspector General studied to determine if drugs associated with
NCDs were properly categorized in the AMP file. The report noted that
eight of 75 NDCs that underwent a manual review appear to be
``incorrectly categorized in the AMP file.'' \2\ The report further
noted that, ``these NDCs should have been categorized by their
manufacturers as innovators.'' \3\
---------------------------------------------------------------------------
\1\ Health and Human Services Inspector General, ``Accuracy of Drug
Categorizations for Medicaid Rebates,'' at i (July 2009).
\2\ Id. at 19.
\3\ Id. at ii.
According to emails acquired by the Committee from the Inspector
General, on March 12, 2009, CMS staff requested the HHS IG provide a
list of the misclassified drugs. On March 16, 2009, the HHS IG did so.
In consultation with the HHS IG, my staff was informed that the
misclassified drugs included EpiPen, Dilaudid , and Prilosec. I have
previously written you asking what steps the Obama Administration took
to hold Mylan accountable for misclassifying the EpiPen--you have
failed to respond thus far. My request was in response to CMS declaring
that ``on multiple occasions, [CMS] provided guidance to the industry
and Mylan on the proper classification of drugs and has expressly
advised Mylan that their classification of EpiPen for purposes of the
Medicaid Drug Rebate Program was incorrect.'' Given this public
pronouncement, Congress and the American public have a right to know
what additional steps, if any, CMS took to hold Mylan and other
---------------------------------------------------------------------------
companies accountable and CMS has an obligation to answer.
These misclassifications could have cost the taxpayers and states
hundreds of millions of dollars. The Obama Administration's silence on
these issues is unwarranted and irresponsible. Accordingly, in addition
to my previous requests regarding EpiPen, please respond to the
following:
1. Please provide all records relating to government
communications with Purdue Pharmaceuticals and Proctor and Gamble
regarding the misclassification of Dilaudid and Prilosec.
2. What steps has CMS taken to ensure that these drugs were
properly classified?
3. Has CMS notified Purdue and Proctor and Gamble that its drugs
were misclassified? If so, how was each notification communicated, when
was each communication made, and what did each company do in response?
4. Has CMS determined how much the taxpayers and states have
overpaid for these drugs? If so, how much? If not, why not?
5. Has the Obama Administration taken any steps to impose a civil
monetary penalty, or any other penalties, upon Purdue or Proctor and
Gamble for misclassifying their drugs? If so, please explain the steps.
If not, why not?
Please number your responses according to their corresponding
questions and respond no later than January 18, 2017. If you have
questions, contact Josh Flynn-Brown of my Judiciary Committee staff at
(202) 224-5225.
Sincerely,
Charles E. Grassley
Chairman
Committee on the Judiciary
______
Prepared Statement of Hon. Orrin G. Hatch,
a U.S. Senator From Utah
WASHINGTON--Senate Finance Committee Chairman Orrin Hatch (R-Utah)
today delivered the following opening statement at the Finance
Committee hearing to consider the nomination of Alex Azar to serve as
the Secretary of the U.S. Department of Health and Human Services
(HHS).
I'd like to welcome Mr. Azar to the Finance Committee this morning.
Thank you for being here and for your willingness to serve in this
important capacity.
Mr. Azar certainly has his work cut out for him. Health and Human
Services is a massive, sprawling department that oversees trillions of
dollars in spending and liabilities and encompasses all areas of our
Nation's health care system. As a result, if confirmed, Mr. Azar's work
will impact the lives of every single American.
That's a big job. It requires knowledge, experience, and, most
important, strong leadership.
Fortunately, our nominee brings all of this to the table, having
nearly 2 decades of experience in the health care sector, including
about 6 years working at the highest levels of HHS.
During his time at HHS, Mr. Azar played key roles in implementing
new policies, including Medicare Part D and the Medicare Advantage
program. He was also a leader in HHS's responses to the anthrax attacks
shortly after 9/11, the SARS and monkeypox crises, and Hurricane
Katrina, among others.
If confirmed, Mr. Azar will be Congress's primary contact on all
matters relating to our Nation's health-care system. He will be
responsible for the ongoing effort to bring down costs, provide greater
access to care, and give patients more choices when it comes to
coverage. Whether we're talking about work to modernize Federal health
programs like Medicare and Medicaid in order to preserve them for
future generations, innovating the CHIP program, or reforming the
private market, Mr. Azar will be the administration's primary policy
driver.
He has made clear his intention to address the growing opioid
epidemic that continues to ravage communities across the country,
including in my home State of Utah. This crisis is robbing families of
loved ones, employers of productive and able workers, and communities
of the safety and security they once enjoyed.
This is an important issue to me and other members of the committee
and I look forward to working with Mr. Azar to figure out how HHS and
CMS can make improvements to save lives.
As many know, I co-authored the Ensuring Patient Access and
Effective Drug Enforcement Act, which has recently come under scrutiny
in relation to the opioid epidemic. This law requires HHS to submit a
report to Congress regarding obstacles to legitimate patient access to
controlled substances and issues with diversion of controlled
substances.
The required report is long overdue, and so, today, I'd like to
impress upon Mr. Azar the importance of getting this report to Congress
so that we can have an opportunity to review and make any necessary
changes to the law that may help turn the tide of this epidemic. I hope
to get his commitment to produce and releasing this report as soon as
possible, once he's confirmed.
He has expressed his commitment to succeeding in these important
endeavors. And, I believe his record shows that he is more than capable
of leading HHS through these next few consequential years.
Of course, there are some on the committee who have already made up
their mind about Mr. Azar and are committed to opposing his nomination.
This is essentially par for the course for the high-profile nominees
that have come before us under this administration. And, as in previous
cases, none of the attacks leveled at Mr. Azar are focused on his
record, his experience, or his qualifications. Instead, we're hearing
talk about supposedly revolving doors and non-existent conflicts of
interest.
While I believe Mr. Azar is more than capable of responding to his
critics on his own, I'd like to take just a moment to address some of
the more prominent attacks we've heard thus far.
Opponents of this nomination have claimed Mr. Azar's work in the
pharmaceutical industry--he's been a senior executive for the past 10
years--disqualifies him to serve in this position.
I would hope that my colleagues would want to avoid creating
standards or setting new precedents where work in the private sector is
somehow a knock against a nominee. That certainly wasn't a standard
they applied to nominees from the previous administration, and it
shouldn't apply to this one.
Mr. Azar has committed to fully adhering to all necessary ethics
requirements, including the Trump administration's requirement
prohibiting nominees from participating in matters involving their
former employers and clients for 2 years after the end of their
government service. In addition, he has committed to divesting any
financial holdings that could present a conflict of interest or even
the appearance such a conflict.
So, we're not talking about anything unethical. We're not talking
about a nominee attempting to unduly profit off his government
position.
Experience in the private sector and dealing with the policies and
regulations that come from government agencies is, in my view, a mark
in favor of a nominee's qualifications. Mr. Azar's work in the
pharmaceutical industry will give him important insights regarding the
impact of policies designed and implemented by HHS. And, when you add
that knowledge and background to the years he spent as a senior
official at HHS, you have an exemplary resume for an HHS Secretary.
Once again, I believe Mr. Azar is more than capable of responding
to what have so far been empty criticisms. By any objective standard,
Mr. Azar is well qualified to serve as Secretary of HHS. My hope is
that we can have a productive hearing today and report his nomination
in short order.
Thank you, once again, Mr. Azar, for being here today. Thank you
for, again, for returning to the call to serve the American people. I
look forward to your testimony.
Before turning to Senator Wyden, I would like to reemphasize my
support for the Children's Health Insurance Program and my commitment
to making sure it gets reauthorized. We have a bipartisan agreement
that was reported out of committee, and I believe that it improves CHIP
for the long-term. Congress has passed patches and fixes, but the time
for short-term solutions is over. CHIP needs to be extended by January
19th, and I'm going to do all I can to make sure we get it done.
Children, their families, and States are counting on us.
______
Prepared Statement of Hon. Ron Wyden,
a U.S. Senator From Oregon
The same Donald Trump who said almost exactly one year ago that
price-hiking drug companies were ``getting away with murder'' has
nominated a drug company executive with a documented history of raising
prescription drug prices to captain the administration's health-care
team. Mr. Alex Azar is here with the Finance Committee today, nominated
to serve as the next Secretary of Health and Human Services.
It's my view that the issues he'll work on, if confirmed, will be
defining domestic issues in 2018. That's because Americans heard a lot
of promises 2 years ago about how great their health care would be
under Trump, and how the era of skyrocketing drug prices was over.
Americans are going to want to know, come November, if the big
guarantees they heard in 2016 ever came to fruition. To say this
administration hasn't yet delivered would be a wild understatement.
Mr. Azar was the president of Eli Lilly's U.S.-based subsidiary,
Lilly USA, from 2012 to 2017. He chaired its U.S. pricing,
reimbursement and access steering committee, which gave him a major
role over drug price increases for every product Lilly marketed in this
country.
Let's look at the track record. The price of Lilly's bone-growth
drug Forteo, used to treat osteoporosis, more than doubled on Mr.
Azar's watch. The price of Effient, used to treat heart disease, more
than doubled. The price of Strattera, used to treat ADHD, more than
doubled. The price of Humalog, used to treat diabetes, more than
doubled. And those are just some of the drugs that were under his
purview as head of Lilly USA.
Mr. Azar told committee staff that while he chaired the company's
pricing committee he never--not even once--signed off on a decrease in
the price of a drug.
This morning the committee will likely hear that this is just the
way things work--it's the system that's to be blamed. My view is,
there's a lot of validity in that. The system is broken. Mr. Azar was a
part of that system.
Given ample opportunity to provide concrete examples as a nominee
of how he'd fix it, Mr. Azar has come up empty.
And if Mr. Azar is confirmed, it won't be the first time the
President and his health-care team broke their promises.
A virtual parade of Trump health care officials have come before
this committee and the Health Committee and promised they'd uphold the
law with respect to the Affordable Care Act. Right out of the gate, it
was Tom Price telling us it would be his job to ``administer the law''
at HHS, not to be a legislator.
The track record there looks miserable, too, because the sabotage
agenda went into effect on day one. Along with their allies in
Congress, the Trump team wasted no time undermining the private health
insurance markets. They cut the open enrollment period in half. They
slashed advertising budgets. They made it harder for people having
difficulty signing up for coverage to get in-person assistance. They
attacked a rule that says women have to have guaranteed, no-cost access
to contraception, but fortunately that move has been held up in the
courts.
They made it easier to sell junk insurance that fails people when
they have a health emergency. All in all, the Trump administration has
made millions of people's health care worse, and they've got no serious
plan to undo the damage.
Mr. Azar is going to have to explain today whether he'll continue
the sabotage agenda as HHS Secretary. And he should, because it stands
in stark contrast to what he did as a member of the Bush administration
to help launch Medicare Part D. He participated in a bus roadshow,
public events, and local media appearances. So when it came to
promoting the Medicare prescription drug benefit, he toured like he was
in the Grateful Dead. Now he's set to join an administration that's
tweeted less about open enrollment than Thanksgiving safety.
There's also been a lot of talk about ``welfare reform'' in 2018.
Mr. Azar told me he believes Medicaid counts as welfare. But everybody
you ask seems to have a different answer for what exactly ``welfare
reform'' means. The common thread to all the Republican talk is this:
deep, draconian cuts to programs like Medicare and Medicaid, Social
Security, anti-hunger programs, support for struggling families.
With respect to Medicaid, this program is at the heart of health
care in America, and it spans generations, from newborn infants to two
out of three seniors in nursing homes. Today, Medicaid is built on a
guarantee. The Trump team wants to end it. They've set in motion plans
that would make it harder for a lot of people to get the care they
need. In some cases it's older Americans and people with disabilities
who need long-term care. In other cases it's adults of limited means--
people who struggle to climb the economic ladder. As the one-time
director of the Oregon Gray Panthers, I came up as an advocate for
seniors, and any policy that risks nursing home care they need is a
non-starter. And furthermore, my view is, you can't get ahead in life
if you don't have your health, so endangering the health care of low-
income Americans is the absolute wrong way to go.
Some of the other issues that might fall under this ``welfare
reform'' umbrella are on the human services side of HHS' jurisdiction--
issues Mr. Azar has no experience managing. Those are all areas that
the committee will need to discuss further today.
One final point--the leaders of both sides of this committee
previously had regular meetings and calls with sitting HHS Secretaries,
Republicans and Democrats. The last HHS Secretary broke with that
tradition to the detriment of bipartisanship, so I was glad to hear Mr.
Azar commit to me that he'd revive it. Thank you for being here today,
Mr. Azar. I appreciate your willingness to serve, and I look forward to
questions.
______
The PEW Charitable Trusts
FACT SHEET
Persuading the Prescribers: Pharmaceutical Industry Marketing and its
Influence on Physicians and Patients
November 11, 2013 Prescription Project
_______________________________________________________________________
In 2012, the pharmaceutical industry spent more than $27 billion on
drug promotion \1\--more than $24 billion on marketing to physicians
and over $3 billion on advertising to consumers (mainly through
television commercials).\2\ This approach is designed to promote drug
companies' products by influencing doctors' prescribing practices.\3\
---------------------------------------------------------------------------
\1\ Cegedim Strategic Data, 2012 U.S. Pharmaceutical Company
Promotion Spending (2013), http://www.skainfo.com/
health_care_market_reports/2012_promotional_spending.pdf.
\2\ Ibid.
\3\ Ashley Wazana, ``Physicians and the Pharmaceutical Industry: Is
a Gift Ever Just a Gift?'', Journal of the American Medical Association
283 (2000): 373-80.
How Does the Pharmaceutical Industry Market its Drugs and
How Much Does it Spend?
NOT ANAILABLE IN TIFF FORMAT]
Source: Cegedim Strategic Data, 2012 U.S. Pharmaceutical Company
Promotion Spending (2013).
Direct Marketing
Detailing: This marketing approach refers to face-to-face promotional
activities directed toward physicians and pharmacy directors.
Pharmaceutical representatives typically visit doctors to pitch their
drugs. Detailing also includes taking doctors out for meals and giving
them gifts in the form of medical textbooks. As of 2012, approximately
72,000 pharmaceutical sales representatives were employed in the United
States.\4\
---------------------------------------------------------------------------
\4\ Jonathan D. Rockoff, ``Drug Reps Soften Their Sales Pitches,''
Wall Street Journal (January 10, 2012), https://www.wsj.com/articles/
SB10001424052970204331304577142763014776148.
Samples: Providing free medication samples to physicians has been shown
to cause significant increases in new prescriptions for the promoted
drug.\5\ Although companies assert that samples benefit indigent
patients, research indicates that most are given to insured patients
whose medications are covered.\6\ Indeed, patients who are given
samples ultimately have higher prescription costs than those who do not
receive them because they are then prescribed the sampled drug rather
than its less-expensive generic alternative.\7\
---------------------------------------------------------------------------
\5\ M.Y. Peay and E.R. Peay, ``The Role of Commercial Sources in
the Adoption of a New Drug,'' Social Science and Medicine 26 (1998):
1183-9.
\6\ Ibid.
\7\ C.G. Alexander, J. Zhang, and A. Basu, ``Characteristics of
Patients Receiving Pharmaceutical Samples and Association Between
Sample Receipt and Out-of-Pocket Prescription Costs,'' Medical Care 46
(2008): 394-402.
Educational and Promotional Meetings: Sales representatives invite
doctors to meetings during which industry-paid physicians discuss the
use of particular drugs. These speakers are often leaders in their
fields, which increases the draw. According to an analysis by
ProPublica, an independent investigative news organization, eight
pharmaceutical companies provided more than $220 million in speaker
payments to physicians in 2010.\8\ The companies often host these
events at restaurants and provide meals to physicians who attend.\9\
---------------------------------------------------------------------------
\8\ Charles Ornstein, Tracy Weber, and Dan Nguyen, ``Piercing the
Veil, More Drug Companies Reveal Payments to Doctors,'' ProPublica,
September 7, 2011, accessed May 21, 2012, http://www.propublica.org/
article/piercing-the-veil-more-drug-companies-reveal-payments-to-
doctors. The eight companies were the only ones to have provided a full
year's worth of data that could be analyzed.
\9\ Charles Ornstein, ``Doctors Dine on Drug Companies' Dime,''
ProPublica (September 7, 2011), http://www.propublica.org/article/
doctors-dine-on-drug-companies-dime.
Promotional Mailings: Pharmaceutical companies send unsolicited
promotional materials to most doctors' offices. Typically, these
brochures tout a drug's benefits and positively describe the results of
recent clinical trials, which are often funded by the same company. One
study found that these materials were highly biased in favor of the
company's products, mainly because they selectively reported trials in
which the sponsored drug outperformed that of competitors.\10\
---------------------------------------------------------------------------
\10\ C. Wick et al., ``The Characteristics of Unsolicited Clinical
Oncology Literature Provided by Pharmaceutical Industry,'' Annals of
Oncology 18 (2007): 1580-82, http://annonc.oxford
journals.org/content/18/9/1580.short?rss=1.
Journal and Web Advertisements: These advertisements are standard
promotional techniques that provide an important source of revenue for
medical journals. The accuracy of statements in such ads is regulated
by the U.S. Food and Drug Administration, or FDA. According to one
study, journal advertising generated the highest return on investment
of all promotional strategies employed by pharmaceutical companies,
with returns ranging from $2.22 to $6.86 per advertising dollar spent
between 1995 and 1999.\11\ In April 2009, FDA warned 14 major
drugmakers for running search ads for many of their products that
highlighted the products' effectiveness without noting any of their
risks.\12\
---------------------------------------------------------------------------
\11\ Scott Neslin, ``ROI Analysis of Pharmaceutical Promotion
(RAPP): An Independent Study'' (2011), http://www.pharmxpert.net/web/
board/b_ne01upload/RAPP%EC%A1%B0%EC%82%
AC.pdf.
\12\ Food and Drug Administration Division of Drug Marketing,
Advertising, and Communications, letters to Biogen Idec, Sanofi Aventis
U.S., Bayer HealthCare Pharmaceuticals, GlaxoSmithKline, Forest
Laboratories Inc., Cephalon Inc., Johnson and Johnson Pharmaceutical
Services, Pfizer Inc., Novartis Pharmaceuticals Corp., Genentech Inc.,
Boehringer Ingelheim Pharmaceuticals Inc., Merck and Co., Hoffmann-La
Roche Inc., and Eli Lilly and Co. (April 2009), http://www.fda.gov/
Drugs/GuidanceComplianceRegulatoryInformation/EnforcementAc
tivitiesbyFDA/
WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/
UCM055773.
Direct-to-Consumer Advertising: In 1997, FDA issued guidance that
enabled pharmaceutical companies to more easily advertise to the
public. Since then, spending on these direct-to-consumer ads has nearly
quadrupled.\13\ One study showed that 43 percent of respondents thought
that only ``completely safe'' drugs were allowed to be advertised.
Direct-to-consumer advertising has proved effective in motivating
patients to ask for the branded product, even when generic equivalents
exist.\14\ Furthermore, these ads have encouraged one-third of
respondents to speak to their doctors about the promoted drug and one-
fifth to request the prescription.\15\ In one study, doctors were more
likely to prescribe a branded antidepressant when asked for it by name
than when patients didn't specify which treatment they wanted.\16\
---------------------------------------------------------------------------
\13\ Julie M. Donohue, Marisa Cevasco, and Meredith B. Rosenthal,
``A Decade of Direct-to-
Consumer Advertising of Prescription Drugs,'' New England Journal of
Medicine 357 (2007): 673-81, http://www.nejm.org/doi/full/10.1056/
NEJMsa070502#t=articleTop.
\14\ M. Peyrot, N.M. Alperstein, D. Van Doren, and L.G. Poli,
``Direct-to-Consumer Ads Can Influence Behavior; Advertising Increases
Consumer Knowledge and Prescription Drug Requests,'' Marketing Health
Services 18 (1998): 26-32.
\15\ Robert A. Bell, Richard L. Kravitz, and Michael S. Wilkes,
``Direct-to-Consumer Prescription Drug Advertising and the Public,''
Journal of General Internal Medicine 14 (1999): 651-57.
\16\ Richard L. Kravitz et al., ``Influence of Patients' Requests
for Direct-to-Consumer Advertised Antidepressants: A Randomized
Controlled Trial,'' Journal of the American Medical Association 293
(2005): 1995-2002.
The United States and New Zealand are the only member countries of the
Organization for Economic Cooperation and Development in which drug
companies can advertise prescription drugs directly to consumers. (The
organization includes 34 of the world's most advanced and emerging
nations in North and South America, Europe, and Asia.)
Indirect Marketing
Continuing Medical Education (CME): In 2011, the pharmaceutical and
medical device industries provided 32 percent of all funding for
continuing medical education courses in the United States--$752 million
out of $2.35 billion.\17\ To prevent these courses from functioning as
veiled marketing, they are regulated by the Accreditation Council for
Continuing Medical Education. However, a 2007 Senate Finance Committee
report found that ``drug companies have used educational grants as a
way to increase the market for their products in recent years.'' \18\
---------------------------------------------------------------------------
\17\ Accreditation Council for Continuing Medical Education, ACCME
2010 Annual Report Data (2011), http://www.accme.org/news-publications/
publications/annual-report-data/accme-annual-report-data-2010.
\18\ Noelle C. Sitthikul, ``Senate Finance Committee Releases
Report on Drug Industry CME Grants,'' FDA Law Blog, May 8, 2007, http:/
/www.fdalawblog.net/fda_law_blog_hyman_phelps/2007/05/
senate_finance_.html.
Grants to Health Advocacy Organizations (HAO): Patient advocates can
mobilize large numbers of people on behalf of a specific issue, often
to the benefit of drug companies that manufacture treatments for their
diseases. One study found that organizations that had received grants
from pharmaceutical manufacturers often endorsed the companies'
positions, while groups that had received minimal financing focused
their advocacy on drugs' potential side effects.\19\
---------------------------------------------------------------------------
\19\ Jessica Marshall and Peter Aldhous, ``Patient Groups Special:
Swallowing the Best Advice?'', New Scientist (October 27, 2006), 18-22.
---------------------------------------------------------------------------
______
U.S. Department of Health and Human Services
FY 2018 Budget in Brief
putting america's health first
FY 2018 President's Budget for HHS
(Dollars in millions)
------------------------------------------------------------------------
2016 2017 \1\ 2018
------------------------------------------------------------------------
Budget Authority $1,119,166 $1,126,789 $1,112,883
Total Outlays 1,103,145 1,130,835 1,131,256
Full-Time Equivalents (FTE) 77,499 79,505 80,027
------------------------------------------------------------------------
\1\ A full-time 2017 appropriation was not enacted at the time the
budget was prepared; therefore, the budget assumes operations under
the Further Continuing Appropriations Act, 2017 (Pub. L. 114-254). The
amounts included for 2017 reflect the annualized level provided by the
Continuing Resolution.
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Putting America's Health First
The Department of Health and Human Services (HHS) is enhancing the
health and well-being of the American people by providing effective
health and human services and by fostering sound, sustained advances in
the sciences underlying medicine, public health, and social services.
The President's Fiscal Year (FY) 2018 Budget supports the Department's
mission by making strategic investments to protect the health and well-
being of Americans; delivering hope and healing to the American people;
promoting patient-centered care; strengthen services to tribes;
investing in the health of America's future; and ensuring responsible
stewardship of taxpayer dollars for long-term sustainability. Achieving
these goals will require HHS to make strategic investments and carry
out our mission in the most effective manner possible.
The President's Budget request for HHS proposes $69 billion in
discretionary budget authority and $1,046 billion in mandatory funding
to help HHS deliver on the promises the Administration has made to the
American people. The Budget focuses resources on direct services and
proven investments while streamlining or eliminating programs that are
duplicative or have limited impact. The Department's approach to
budgeting this fiscal year puts the American people first by supporting
fiscal discipline within the Federal Government and saving taxpayers a
net estimated $665 billion over 10 years.
A Commitment to Fiscal Responsibility--Restoring Trust to Generations
of Americans
The FY 2018 President's budget brings Federal spending under control
and returns the Federal budget to balance within 10 years. Of its total
net estimated 10-year savings over this period, the HHS Budget
contributes $665 billion in mandatory savings primarily from giving
States new flexibilities to operate their Medicaid programs under per
capita caps or block grants beginning in Fiscal Year 2020. The
President has embraced these bold reforms that save, strengthen, and
secure the promises of the Federal Government's major benefits
programs. The Budget ensures that Medicaid and other programs focus on
the most vulnerable Americans that they were intended to serve--the
elderly, people with disabilities, children, and pregnant women.
Failing to tackle unsustainable deficit spending means passing growing
debt on to our children and grandchildren and creating serious economic
damage. The Federal Government's deficit spending has created a growing
debt that cannot be sustained, because it is consuming an increasing
portion of national income and limiting resources for private
investment and public programs. Over the next 10 years, interest
payments on our national debt are projected to consume trillions of
dollars and surpass annual spending on national defense, Medicaid, or
science.
Without action, future generations of Americans will be burdened with
unsustainable debt. To restore the people's trust, we must take a
fiscally sustainable approach. The Budget begins the process of
expanding choices for individuals and families; enabling market forces
and competition to encourage innovation and restrain costs; encouraging
self-sufficiency; and promoting federalism, allowing States and
localities the flexibility they need to serve their populations.
With responsibility for the major drivers of mandatory spending in the
Budget, HHS is in a unique position to help lead the Administration's
efforts to rebuild fiscal solvency and to secure the trust of current
and future generations of Americans.
Reforming the American Health Care System
Providing Relief From Obamacare
The Budget includes $250 billion in net deficit savings over 10 years
associated with health care reform as part of the Administration's
commitment to expand choices, increase access, and lower premiums. The
Administration continues to support a repeal and replace approach that
improves Medicaid's sustainability and targets resources to those most
in need, eliminates Obamacare's onerous taxes and mandates, provides
funding for States to stabilize markets and ensure a smooth transition
away from Obamacare, and helps Americans purchase the coverage they
want through the use of tax credits and expanded Health Savings
Accounts. The Administration urges the Congress to continue its work to
repeal and replace Obamacare. The $250 billion in combined savings
accrue to both Treasury and HHS.
The Administration will continue to work with Congress to provide for a
stable transition from the burdensome requirements of Obamacare to a
health care system that provides Americans with access to care that
meets their needs and increases options for patients and providers. The
Administration also supports State flexibility to create a free and
open health care market and will empower States to make decisions that
work best for their markets. In light of these goals, the Budget
promotes efficient operations and funds critical activities to continue
to operate the law's health insurance Exchanges.
Reforming Medicaid
The Budget fulfills the President's pledge to give States the resources
and flexibility they need to care for the most vulnerable in their
communities through Medicaid. To this end, the Budget reforms Medicaid
funding to States starting in FY 2020 through either a per capita cap
or a block grant. The Budget also provides other flexibilities to
States and encourages them to innovate and test new ideas that will
improve access to care and health outcomes. These proposals will save
$610 billion through FY 2027 and will allow States to prioritize
Federal resources for the most vulnerable populations.
The Budget extends the Children's Health Insurance Program for 2 years
(through FY 2019) and makes modest reforms that taken together save a
net $5.8 billion over the Budget window. The reforms to the Children's
Health Insurance Program ensure the program's focus on serving the most
vulnerable low-income families.
Modernizing the Medical Liability System
The current medical liability system disproportionately benefits a
relatively small group of plaintiffs and trial lawyers at the expense
of adding significantly to the cost of health care for every American
and imposing a significant burden on health care providers. The current
medical liability system does not work for patients or providers, nor
does it promote high-quality, evidence-based care. The Budget proposes
medical liability reforms that will save HHS programs $31.8 billion
over 10 years and $55 billion to the Federal Government overall. A
significant portion of these savings are attributable to the estimated
reduction in unnecessary services and curbing the practice of defensive
medicine. These medical liability reforms will benefit all Americans by
cutting unnecessary health care spending.
In addition to reducing health care costs, these reforms will help
physicians focus on patients and on evidence-based medicine rather than
on frivolous lawsuits. By providing a safe harbor based on clinical
guidelines, physicians can focus on delivering effective care, and--if
an inherently risky medical procedure does not work out as intended--
physicians will be able to express sympathy to a grieving family
without fear of giving rise to a lawsuit.
Specifically, the Budget proposes the following medical liability
reforms:
Capping awards for noneconomic damages at $250,000 indexed to
inflation;
Providing safe harbors for providers based on clinical standards;
Authorizing the Secretary to provide guidance to States to create
expert panels and administrative health care tribunals;
Allowing evidence of a claimants' income from other sources such as
workers compensation and auto insurance to be introduced at trial;
Providing for a 3-year statute of limitations;
Allowing courts to modify attorney's fee arrangements;
Establishing a fair-share rule to replace the current rule of joint
and several liability;
Excluding provider expressions of regret or apology from evidence;
and
Requiring courts to honor a request by either party to pay damages
in periodic payments for any award equaling or exceeding $50,000.
Enhancing Direct-to-Patient Relationships
HHS is committed to reducing regulatory burdens facing medical
professionals, especially those serving in rural areas. To achieve this
goal, HHS continues to look for ways to improve or eliminate
regulations that impede the ability of medical professionals to provide
the best possible care to their patients. HHS also believes that health
care providers are a valuable resource whose input and ideas are
essential to a positive health care reform effort. HHS also is
committed to an open and transparent process for developing new
voluntary payment models that providers can participate in. Finally,
HHS has established various avenues of technical assistance to help
clinicians be successful in providing efficient, high-quality care to
their patients.
Achieving the President's goals to reform Medicaid will require
providing States with more flexibility to improve health care delivery
to meet the needs of their unique populations. Direct Primary Care
practices, in which physicians offer primary care services to patients
at a set price, generally without payer or insurer involvement, are a
mechanism to improve physician-patient relationships. Some State
Medicaid programs are already testing this innovative care delivery
model. HHS will explore opportunities for States and providers to
further expand Direct Primary Care, which will support improved health
outcomes for Medicaid populations.
Protecting the Health and Well-Being of Americans
Supporting Life-Saving Preparedness and Response Activities
The Department fills a unique Federal role in emergency preparedness
and response. HHS is the Federal Government's lead agency in responding
to public health emergencies. The Department coordinates the prevention
of, preparation for, and response to public health emergencies and
disasters. It supports numerous critical activities to enhance the
Federal, State, and local capacity to respond to public health
disasters--from outbreaks of infectious disease to chemical,
biological, radiological, nuclear, and cyber threats.
The Budget provides $2.9 billion to ensure that the Department is
equipped to support life-saving preparedness and response activities
aimed at addressing public health disasters and threats. This includes
maintaining key investments in biodefense capabilities.
Emergency preparedness initiatives to address pandemic influenza, as
well as the research and development of medical countermeasures, are
described in greater detail below.
Pandemic Influenza
The Budget supports activities within the Public Health and Social
Services Emergency fund to respond to and protect the American people
from pandemic influenza threats, such as the H7N9 virus circulating in
China. These activities include maintenance of the current stockpiles
of vaccines as well as sustaining domestic vaccine manufacturing
infrastructure.
Human infections with a new avian influenza (H7N9) virus were first
reported internationally in China in March 2013. The World Health
Organization has reported 566 human infections with the H7N9 virus
during the fifth epidemic, making it the largest to date. This count
brings the cumulative number of H7N9 cases reported by the World Health
Organization to 1,364.
The FY 2018 Budget includes a $207 million investment to respond to the
needs of the American people in the event of an influenza pandemic.
Research and Development of Medical Countermeasures
The Budget invests $1.02 billion into the research and development of
medical countermeasures needed during disasters. Using these funds, the
Department partners with industry leaders to develop an effective
response capability to protect Americans from radiological, nuclear,
chemical, and biological threats. The Department supports a broad
portfolio of countermeasures to bridge the gap from early discovery to
advanced development and procurement. These investments meet a unique
Federal role to partner with industry in developing drugs and other
countermeasures for which a sufficient market is lacking.
Preparedness Grants
The Budget restructures HHS preparedness grants to direct resources to
States with the greatest need and innovative approaches. The Budget
will introduce competition, risk, and link awards to performance across
ASPR's Hospital Preparedness Program and CDC's Public Health and
Emergency Preparedness Program. The grants will support entities that
are most innovative in their approach to health care delivery system
readiness and public health preparedness.
Delivering Hope and Healing to America
The opioid epidemic is the deadliest drug epidemic in American history.
Deaths from opioid overdose have risen steadily over the past 2 decades
and have become the leading cause of death from injury in the United
States, claiming 91 lives every day. We are losing more Americans to
overdoses every year than we did during the entire Vietnam War.
The Administration has made combating opioid abuse and fighting
addiction an Administration-wide effort and priority, and the Budget
reflects this commitment. It continues to invest in activities to fight
opioid abuse, maintains funding for substance abuse treatment, and
seeks to improve prescribing practices and the use of medication-
assisted treatment.
The Budget also invests in high-priority mental health initiatives by
targeting resources for serious mental illness, suicide prevention,
homelessness prevention, and children's mental health.
Improving Prescribing Practices and Expanding Use of Medication-
Assisted Treatment
To fight against opioid abuse, medication must be correctly prescribed
and utilized. HHS is focused on providing support for cutting-edge
research on pain addiction and strengthening our understanding of the
epidemic through health surveillance. In addition, the Budget makes
investments to improve access to treatment and recovery services,
target the availability and distribution of overdose-reversing drugs,
and advance better practices for pain management.
Improving Access to Treatment and Recovery Services
Medication-assisted treatment is a proven effective intervention for
individuals suffering from addiction. The Budget includes $500 million
for the Substance Abuse and Mental Health Administration's State
Targeted Response to the Opioid Crisis Grants authorized in the 21st
Century Cures Act to expand access to life-saving, transformative
treatments, including Medication-Assisted Treatment. The Budget also
continues the $1.9 billion Substance Abuse Block Grant, which States
can use to provide life-saving treatments, and $25 million in SAMHSA
for other targeted efforts focused specifically on expanding access to
critical interventions.
Targeting Availability and Distribution of Overdose-Reversing Drugs
First responders to an overdose in progress have precious little time
to save a life by reversing the effects of an overdose. The FY 2018
Budget for SAMHSA includes $24 million to equip first responders with
overdose reversing drugs and to train them on their use, supporting the
implementation of key provisions of the Comprehensive Addiction and
Recovery Act.
Advancing Better Practices for Pain Management
While actions to address prescription opioid abuse must focus on both
prescribers and high-risk patients, prescribers are the first line of
defense for preventing inappropriate access. The FY 2018 CDC Budget
includes $75.4 million to improve the way opioids are prescribed
through clinical practice guidelines and support State programs, which
help health care providers offer safer, more effective treatments while
reducing opioid-related abuse and overdose. CDC aims to save lives and
prevent prescription opioid overdoses by equipping providers with the
knowledge, tools, and guidance they need.
In addition, the Centers for Medicare and Medicaid Services' Budget
continues to support the agency's work to implement more effective,
patient-centered strategies to reduce the risk of opioid use disorders,
overdoses, inappropriate prescribing, and drug diversion.
Improving Access to Mental Health Treatment
In 2015, an estimated 10 million American adults battled serious mental
illness, such as a psychotic or serious mood or anxiety disorder. The
Budget includes high-priority mental health funding that addresses
suicide prevention, homelessness prevention, and children's mental
health. It also includes funding to address the needs of adults with
serious mental illness and children experiencing a mental health
crisis. The Budget provides $119 million for the Children's Mental
Health Services program, which helps States, Tribes, and communities
deliver evidence-based services and support for children and youth with
serious mental health concerns. These funds facilitate effective
collaboration between child and youth-serving systems such as juvenile
justice, child welfare, and education. The Budget also proposes that up
to 10 percent of the funds will be available for a new demonstration
project focused on earlier interventions. This new set-aside reflects
recent research by the National Institute on Mental Health indicating
that earlier psychosocial interventions with those who are high-risk
may prevent the further development of serious emotional disturbances
and ultimately serious mental illness.
The Budget maintains $60 million in critical funding for grants to
States, colleges, and the suicide prevention resource center to raise
suicide awareness and disseminate best practices for prevention. The
Budget also continues to provide funding for the National Suicide
Prevention Lifeline, which coordinates a national network of crisis
centers by providing suicide prevention and crisis intervention
services. Those seeking help can reach the Lifeline at 1-800-273-TALK
at any time, day or night.
Providing Patient-Centered Care
HHS is committed to addressing the challenges many Americans continue
to confront under a health care system that is failing to meet their
needs. The Department is supporting a patient-centered health care
reform effort that is aimed at empowering patients, families, and
doctors when it comes to making health care decisions. HHS is making
progress toward this priority by taking administrative and regulatory
actions that will provide the American people relief from the current
law, build a partnership with states to improve health care choices for
patients, reform the medical liability system, and enhance the doctor-
patient relationship. In FY 2018, the Department will invest nearly
$400 million in services, training for medical professionals, and
approaches that respond to the diverse health care needs across
America.
Strengthening Services to Tribes
HHS is committed to providing quality health care to over 2.2 million
American Indian and Alaska Native people by effectively leveraging
resources and implementing new and innovative ways to improve access to
and the delivery of quality health care. As part of the unique
government-to-government relationship between the Federal Government
and Tribal Governments, the Indian Health Service provides health care
to members of more than 567 Federally-recognized tribes. The FY 2018
IHS Budget prioritizes funding for direct health care services,
including behavioral health services.
Prioritizing Direct Health Services in Indian Country
The Budget reflects HHS's high-priority commitment to Indian Country
and protects direct health care investments. In FY 2018, the Budget
maintains funding for clinical services at $3.3 billion, which includes
inpatient and outpatient care in hospitals and clinics, behavioral
health services, and dental health services. In FY 2018, IHS estimates
that they will serve 2.2 million American Indians and Alaska Natives.
Investing in the Health of America's Future
The percentage of children with obesity in the United States has more
than tripled since the 1970s. Today, nearly 20 percent of school-aged
children are obese. Children with obesity are at higher risk for having
other chronic health conditions and diseases that impact physical
health, such as asthma, sleep apnea, bone and joint problems, type 2
diabetes, and risk factors for heart disease.
The Budget represents a commitment to uplifting the health of the next
generation by investing in services that promote healthy eating and
physical activity. To accomplish this priority, the Budget invests in a
new CDC block grant to address childhood obesity and other state
priorities, and enhances Children's Health Insurance Program
flexibility.
CDC Childhood Obesity and America's Health Block Grant
The FY 2018 Budget will support investments in the most effective
childhood obesity prevention and intervention strategies within CDC and
promote better nutrition, increased physical activity, and prevention
of future chronic illness. CDC will continue to provide funding to
States to implement programs intended to reduce the risk factors
associated with childhood obesity, manage chronic conditions in
schools, and promote the well-being and healthy development of all
children and youth.
The Budget includes a new CDC $500 million America's Health Block Grant
to increase State flexibility and focus on leading public health
challenges. The newly established block grant will provide flexibility
in FY 2018 for each State to implement specific interventions that
address its population's unique public health issues, including
interventions to spur improvements in physical activity and the
nutrition of children and adolescents.
Responsible Stewardship of Taxpayer Dollars and Redefining the Federal
Role
The Budget allows HHS to continue to support priority activities at an
overall lower level while restoring fiscal discipline and promoting
long-term fiscal stability across the Federal Government. In order to
make targeted, strategic investments and carry out the Department's
mission in the most efficient manner possible, the Budget proposes
reorganizations and specific HHS efficiencies, proposals to revisit key
partnerships within the private sector, and proposals to strengthen the
integrity of the Medicare and Medicaid programs.
Reorganizations and HHS-Specific Efficiencies
While large-scale reorganization, workforce restructuring, and
efficiency proposals are under development within the Department, the
Budget offers select HHS restructuring and efficiency proposals.
Medicare Appeals
HHS remains committed to working with Congress on comprehensive and
common sense reforms to the Medicare appeals process. The Budget
includes investing $1.3 billion over 10 years to address the pending
backlog and HHS is pursuing reforms to revamp the process to address
appeals as early as possible and prevent escalation to subsequent
levels. These changes will make the appeals system easier to navigate,
increase adjudicatory capacity to address incoming annual receipts, and
reduce backlogged appeals pending at the Office of Medicare Hearings
and Appeals and the Departmental Appeals Board. The Department is
committed to work with Congress to address the Medicare appeals
backlog.
National Institutes of Health (NIH) Structural Changes
NIH will continue to support core mission-critical activities in the
Budget, while implementing policies to reduce burden on its grantees.
On average, from FY 1994 to FY 2014, NIH spent approximately 30 percent
of its research resources on indirect costs, leaving only 70 percent
for direct research and other supporting research activities. Other
entities, including private foundations and payers, spend a much higher
portion of their grants on direct science. The current indirect rate
setting process requires each grantee to provide hundreds of pages of
documentation to negotiate their indirect rate with the Government.
NIH will implement reforms to release grantees from the costly and
time-consuming indirect rate setting process and reporting
requirements. Applying a uniform indirect cost rate to all grants
mitigates the risk for fraud and abuse because it can be simply and
uniformly applied to grantees.
The Budget includes this critical reform to reduce indirect costs and
preserve more funding for direct science.
The Budget also proposes the elimination of the Fogarty International
Center, but retains all Federal staff and maintains key activities in
other NIH Institutes and Centers. This change will enable NIH to focus
on higher priority activities.
The Budget consolidates the Agency for Healthcare Research and Quality
into NIH and maintains $272 million in discretionary funding for these
activities. As part of this consolidation, NIH will conduct a review of
health services research across NIH and develop a strategy to ensure
that the highest priority health services research is conducted and
made available across the Federal Government. The consolidation
proposal preserves key activities, such as patient safety research,
that improve the quality and safety of American health care. The Budget
reduces or eliminates lower-priority programs that overlap with
activities administered by other components of HHS.
Revisiting Key Partnerships With the Private Sector
The Budget envisions a recalibration of how to pay for the Food and
Drug Administration's (FDA) premarket review activities. Industry fees
are increased to fund 100 percent of costs for premarket review and
approval activities in the animal drug, animal generic, prescription
and generic drug, biosimilar, and medical device programs. In a
constrained budget environment, industries that directly benefit from
FDA's administrative actions can and should pay to support FDA's
capacity. The fee-funded approach is consistent with the overarching
goals of the Administration's Budget, which are to reprioritize Federal
spending to advance the safety and security of the American people. The
Budget also includes reforms that balance the demand for scientific
rigor and access to reliable, life-saving cures. In addition, the
Budget will include regulatory relief to the industry and speed the
development of safe and effective medical products.
The Budget allows FDA to remain an acknowledged leader among the
world's regulatory agencies in both the number of new drugs approved
each year and in the timeliness of review. These proposals will allow
FDA to continue carrying out its statutory responsibilities of
protecting public health by promoting innovative, safe treatments that
are responsive to the needs of the American people.
Strengthening the Integrity of Medicare and Medicaid
The Budget strengthens the integrity and sustainability of Medicare and
Medicaid by investing an additional $70 million in new Health Care
Fraud and Abuse Control Program funding in FY 2018, targeting
activities that prevent fraud, waste, and abuse and promote quality,
patient-centered health care.
The increase in funding reflects the Administration's commitment to
fighting fraud and the belief that this investment will pay off in
significant returns to the Medicare Trust Fund and the Treasury. For
example, recent reports to Congress show Medicare program integrity
efforts yielding approximately a $12 to $1 return and law enforcement
and litigation efforts yielding a $5 to $1 return.
______
FROM THE PRESIDENT'S BUDGET FOR FISCAL YEAR 2018
New Policies for Jobs and Growth
The President's Budget proposes the following bold steps to spark
faster economic growth, balance the budget within 10 years, and finance
important new priorities.
Control Federal Spending. The first step is to bring Federal
spending under control and return the Federal budget to balance within
10 years. Deficit spending has become an ingrained part of the culture
in the Nation's capital. It must end to avoid passing unsustainable
levels of debt on to our children and grandchildren and causing serious
economic damage. When debt levels keep increasing, more and more of the
Nation's resources are required to service that debt and are diverted
away from Government services that citizens depend on. To help correct
this and reach our budget goal in 10 years, the Budget includes $3.6
trillion in spending reductions over 10 years, the most ever proposed
by any President in a Budget. By including the anticipated economic
gains that will result from the President's fiscal, economic, and
regulatory policies, the deficit will be reduced by $5.6 trillion
compared to the current fiscal path.
As a result, by the end of the 10-year budget window, when the
budget reaches balance, publicly held debt will be reduced to 60
percent of GDP, the lowest level since 2010, when the economic policies
of the last administration took effect. Under this plan, the debt will
continue to fall both in nominal dollars and as a share of GDP beyond
that point, putting us on a path to repay the debt in full within a few
decades. Bringing the budget into surplus and reducing the level of
debt sets up a virtuous cycle in which fewer tax dollars are needed to
service the debt. This increases budget flexibility, in which the
Government can pursue other needed priorities. Reduced Federal
borrowing on the capital markets also frees up capital to flow to
productivity-enhancing investments, leading to higher economic growth.
The following are a few of the ways we will bring spending under
control:
Repeal and Replace Obamacare. The Budget includes $250 billion in
deficit savings associated with health care reform as part of the
President's commitment to rescue Americans from the failures of
Obamacare, and to expand choice, increase access, and lower premiums.
The President supports a repeal and replace approach that improves
Medicaid's sustainability and targets resources to those most in need,
eliminates Obamacare's onerous taxes and mandates, provides funding for
States to stabilize markets and ensure a smooth transition away from
Obamacare, and helps Americans purchase the coverage they want through
the use of tax credits and expanded Health Savings Accounts. Repealing
Obamacare and its regulations on businesses will also increase
employment, thereby increasing GDP and creating much needed economic
growth. The Administration applauds the House's passage of the American
Health Care Act and is committed to working with the Congress to repeal
and replace Obamacare.
The Administration is committed to providing needed flexibility to
issuers to help attract healthy consumers to enroll in health insurance
coverage, improve the risk pool and bring stability and certainty to
the individual and small group markets, while increasing the options
for patients and providers. The Administration also supports State
flexibility and control to create a free and open health care market
and will continue to empower States to make decisions that work best
for their markets. In light of these goals, the Budget promotes
efficient operations and only funds critical activities for the Health
Insurance Exchanges. The Administration will continue to work with the
Congress to provide for a stable transition from the burdensome
requirements of Obamacare and transition to a health care system
focused on these core values.
Reform Medicaid. To realign financial incentives and provide
stability to both Federal and State budgets, the Budget proposes to
reform Medicaid by giving States the choice between a per capita cap
and a block grant and empowering States to innovate and prioritize
Medicaid dollars to the most vulnerable populations. States will have
more flexibility to control costs and design individual, State-based
solutions to provide better care to Medicaid beneficiaries. These
reforms are projected to save $610 billion over 10 years.
Support the Highest Priority Biomedical Research and Development.
The Budget institutes policies to ensure that Federal resources
maximally support the highest priority biomedical science by reducing
reimbursement of indirect costs (and thus focusing a higher percentage
of spending on direct research costs) and implementing changes to the
National Institutes of Health's (NIH) structure to improve efficiencies
in the research enterprise. In 2018, the Department of Health and Human
Services (HHS) and NIH will develop policies to reduce the burden of
regulation on recipients of NIH funding consistent with the
Administration's initiatives on regulatory reform and the goals
articulated for the new Research Policy Board established in the 21st
Century Cures Act.
Provide a Path Toward Welfare Reform. The Budget provides a path
toward welfare reform, particularly to encourage those individuals
dependent on the Government to return to the workforce. In doing so,
this Budget includes Supplemental Nutrition Assistance Program (SNAP)
reforms that tighten eligibility and encourage work, and proposals that
strengthen child support and limit the Earned Income Tax Credit (EITC)
and the Child Tax Credit (CTC) to those who are authorized to work in
the United States.
As a primary component of the social safety net, SNAP--formerly
Food Stamps--has grown significantly in the past decade. As expected,
SNAP participation grew to historic levels during the recession.
However, despite improvements in unemployment since the recession
ended, SNAP participation remains persistently high.
The Budget proposes a series of reforms to SNAP that close
eligibility loopholes, target benefits to the neediest households, and
require able-bodied adults to work. Combined, these reforms will reduce
SNAP expenditures while maintaining the basic assistance low-income
families need to weather hard times. The Budget also proposes SNAP
reforms that will re-balance the State-Federal partnership in providing
benefits by establishing a State match for benefit costs. The Budget
assumes a gradual phase-in of the match, beginning with a national
average of 10 percent in 2020 and increasing to an average of 25
percent by 2023. To help States manage their costs, in addition to the
currently available operational choices States make that can impact
participation rates and benefit calculations, new flexibilities to
allow States to establish locally appropriate benefit levels will be
considered.
The Budget also includes a number of proposals that strengthen the
Child Support Enforcement Program, providing State agencies additional
tools to create stronger, more efficient child support programs that
facilitate family self-sufficiency and promote responsible parenthood.
Specifically, a suite of Establishment and Enforcement proposals serves
to increase child support collections that in turn result in savings to
Federal benefits programs, and a Child Support Technology Fund will
allow States to replace aging information technology systems to
increase security, efficiency, and program integrity.
The Budget also proposes to require a Social Security Number (SSN)
that is valid for work in order to claim the CTC and EITC. Under
current law, individuals who do not have SSNs valid for work can claim
the CTC, including the refundable portion of the credit. This proposal
would ensure only people who are authorized to work in the United
States are eligible for the CTC. In addition, this proposal fixes gaps
in current administrative practice for EITC filers that allowed some
people with SSNs that are not valid for work to still claim the EITC.
Table S-3. Baseline by Category \1\
(In billions of dollars)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Totals
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 -------------------------
2018-2022 2018-2027
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Outlays:
Discretionary programs:
Defense........................................... $585 $592 $600 $623 $640 $653 $665 $676 $695 $713 $732 $750 $3,181 $6,747
Non-defense....................................... 600 624 618 629 637 650 659 672 688 705 722 739 3,193 6,718
-------------------------------------------------------------------------------------------------------------------------------------
Subtotal, discretionary programs.............. 1,185 1,215 1,219 1,251 1,277 1,303 1,323 1,348 1,384 1,418 1,453 1,488 6,373 13,464
Mandatory programs:
Social Security................................... 910 946 1,005 1,070 1,138 1,207 1,281 1,362 1,448 1,537 1,630 1,728 5,702 13,406
Medicare.......................................... 588 593 582 646 701 757 854 885 913 1,012 1,106 1,195 3,541 8,650
Medicaid.......................................... 368 378 408 432 454 480 507 537 570 604 648 688 2,280 5,328
Other mandatory programs.......................... 560 656 589 626 643 670 717 719 726 759 821 846 3,244 7,115
-------------------------------------------------------------------------------------------------------------------------------------
Subtotal, mandatory programs.................. 2,427 2,573 2,583 2,774 2,936 3,114 3,359 3,503 3,656 3,912 4,205 4,457 14,767 34,500
Net interest...................................... 240 276 316 372 431 487 542 592 634 670 706 741 2,147 5,489
-------------------------------------------------------------------------------------------------------------------------------------
Total outlays................................. 3,853 4,065 4,118 4,398 4,643 4,905 5,224 5,443 5,673 6,000 6,364 6,687 23,287 53,453
Receipts:
Individual income taxes............................... 1,546 1,660 1,836 1,934 2,042 2,165 2,291 2,425 2,568 2,719 2,880 3,058 10,268 23,918
Corporation income taxes.............................. 300 324 355 375 401 400 414 425 439 455 475 497 1,945 4,235
Social insurance and retirement receipts:
Social Security payroll taxes..................... 810 857 892 931 972 1,027 1,081 1,133 1,191 1,251 1,316 1,379 4,903 11,173
Medicare payroll taxes............................ 247 258 270 283 297 315 332 348 367 386 407 427 1,497 3,432
Unemployment insurance............................ 49 49 50 49 49 50 51 52 53 54 56 57 248 519
Other retirement.................................. 9 10 10 11 11 12 12 13 13 14 15 16 56 127
Excise taxes.......................................... 95 87 106 107 110 114 116 119 123 127 131 136 553 1,189
Estate and gift taxes................................. 21 23 24 26 28 29 31 33 36 38 40 43 139 328
Customs duties........................................ 35 34 40 42 43 44 46 50 53 56 60 65 214 499
Deposits of earnings, Federal Reserve System.......... 116 97 70 56 49 51 60 70 78 86 91 98 286 709
Other miscellaneous receipts.......................... 40 60 54 56 57 58 60 61 64 65 67 69 284 610
-------------------------------------------------------------------------------------------------------------------------------------
Total receipts.................................... 3,268 3,460 3,707 3,869 4,059 4,264 4,495 4,730 4,984 5,251 5,538 5,844 20,394 46,741
-------------------------------------------------------------------------------------------------------------------------------------
Deficit................................................... 585 605 411 529 584 641 728 713 689 749 826 842 2,894 6,712
Net interest.......................................... 240 276 316 372 431 487 542 592 634 670 706 741 2,147 5,489
Primary deficit....................................... 345 329 95 157 153 154 187 121 55 79 120 101 746 1,224
On-budget deficit..................................... 620 647 436 533 564 612 682 640 593 627 681 668 2,826 6,035
Off-budget deficit/surplus (-)........................ -36 -42 -25 -4 20 29 47 72 97 122 145 174 68 678
Memorandum, budget authority for discretionary programs:
Defense............................................... 607 616 616 630 645 661 677 694 711 729 747 765 3,229 6,875
Non-defense........................................... 560 551 548 562 575 589 604 619 634 650 667 683 2,879 6,133
-------------------------------------------------------------------------------------------------------------------------------------
Total, discretionary budget authority............. 1,167 1,167 1,164 1,192 1,221 1,250 1,281 1,313 1,346 1,379 1,414 1,449 6,108 13,008
Memorandum, totals with pre-policy economic assumptions:
Receipts.............................................. 3,268 3,467 3,707 3,838 3,991 4,151 4,330 4,505 4,703 4,902 5,116 5,339 20,017 44,581
Outlays............................................... 3,853 4,072 4,120 4,392 4,638 4,894 5,211 5,431 5,659 5,984 6,350 6,678 23,255 53,356
-------------------------------------------------------------------------------------------------------------------------------------
Deficit........................................... 585 605 413 553 647 743 881 925 956 1,082 1,234 1,338 3,238 8,775
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Baseline estimates are on the basis of the economic assumptions shown in Table S-9, which incorporate the effects of the Administration's fiscal policies. Baseline totals reflecting
current-law economic assumptions are shown in a memorandum bank.
Table S-4. Proposed Budget by Category
(In billions of dollars)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Totals
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 -------------------------
2018-2022 2018-2027
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Outlays:
Discretionary programs:
Defense........................................... $585 $594 $643 $665 $670 $667 $662 $665 $679 $693 $708 $722 $3,307 $6,774
Non-defense....................................... 600 619 601 567 537 506 485 464 455 446 437 429 2,696 4,927
-------------------------------------------------------------------------------------------------------------------------------------
Subtotal, discretionary programs.............. 1,185 1,213 1,244 1,232 1,207 1,173 1,148 1,129 1,134 1,139 1,145 1,151 6,003 11,701
Mandatory programs:
Social Security................................... 910 946 1,005 1,070 1,137 1,205 1,279 1,360 1,446 1,535 1,628 1,725 5,696 13,392
Medicare.......................................... 588 593 582 646 700 756 851 882 910 1,017 1,085 1,166 3,535 8,594
Medicaid.......................................... 368 378 404 423 439 460 467 477 490 499 518 524 2,193 4,701
Other mandatory programs.......................... 560 656 570 603 609 622 658 653 649 667 687 678 3,062 6,396
Allowance for Obamacare repeal and replacement.... ....... ....... -30 -30 -90 -130 -140 -155 -160 -170 -170 -175 -420 -1,250
Allowance for infrastructure initiative........... ....... ....... 5 25 40 50 40 20 10 5 5 ....... 160 200
-------------------------------------------------------------------------------------------------------------------------------------
Subtotal, mandatory programs.................. 2,427 2,573 2,535 2,736 2,835 2,963 3,156 3,237 3,345 3,553 3,754 3,919 14,226 32,033
Net interest.......................................... 240 276 315 371 428 481 528 567 595 613 629 639 2,123 5,166
-------------------------------------------------------------------------------------------------------------------------------------
Total outlays..................................... 3,853 4,062 4,094 4,340 4,470 4,617 4,832 4,933 5,073 5,306 5,527 5,708 22,353 48,901
Receipts:
Individual income taxes............................... 1,546 1,660 1,836 1,935 2,044 2,167 2,293 2,428 2,572 2,723 2,884 3,062 10,275 23,945
Corporation income taxes.............................. 300 324 355 375 401 400 414 425 439 455 475 497 1,946 4,236
Social insurance and retirement receipts:
Social Security payroll taxes..................... 810 857 892 931 972 1,027 1,081 1,133 1,191 1,251 1,316 1,379 4,903 11,173
Medicare payroll taxes............................ 247 258 270 283 297 315 332 348 367 386 407 427 1,497 3,432
Unemployment insurance............................ 49 49 50 49 50 53 55 54 56 56 59 62 257 543
Other retirement.................................. 9 10 12 14 16 18 20 22 23 24 25 26 80 199
Excise taxes.......................................... 95 87 106 107 110 99 101 104 106 109 113 117 524 1,072
Estate and gift taxes................................. 21 23 24 26 28 29 31 33 36 38 40 43 139 328
Customs duties........................................ 35 34 40 42 43 44 46 50 53 56 60 65 214 499
Deposits of earnings, Federal Reserve System.......... 116 97 70 56 50 52 61 71 78 87 92 99 290 717
Other miscellaneous receipts.......................... 40 60 54 55 57 57 59 61 63 64 66 69 282 606
Allowance for Obamacare repeal and replacement........ ....... ....... -55 -60 -85 -100 -105 -115 -120 -120 -120 -120 -405 -1,000
-------------------------------------------------------------------------------------------------------------------------------------
Total receipts.................................... 3,268 3,460 3,654 3,814 3,982 4,161 4,390 4,615 4,864 5,130 5,417 5,724 20,001 45,751
-------------------------------------------------------------------------------------------------------------------------------------
Deficit/surplus (-)....................................... 585 603 440 526 488 456 442 319 209 176 110 -16 2,351 3,150
Net interest.......................................... 240 276 315 371 428 481 528 567 595 613 629 639 2,123 5,166
Primary deficit/surplus (-)........................... 345 326 125 155 60 -25 -87 -249 -386 -438 -518 -654 228 -2,017
On-budget deficit/surplus (-)......................... 620 644 466 534 472 431 399 251 117 59 -30 -185 2,301 2,514
Off-budget deficit/surplus (-)........................ -36 -42 -25 -8 16 25 42 68 92 117 140 169 50 636
Memorandum, budget authority for discretionary programs:
Defense............................................... 607 646 668 668 668 666 665 679 693 707 722 737 3,335 6,873
Non-defense........................................... 560 536 479 464 450 428 419 410 402 394 386 378 2,239 4,209
-------------------------------------------------------------------------------------------------------------------------------------
Total, discretionary funding...................... 1,167 1,182 1,147 1,132 1,118 1,094 1,084 1,089 1,095 1,101 1,108 1,115 5,574 11,081
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Table S-5. Proposed Budget by Category as a Percent of GDP
(As a percent of GDP)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Totals
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 ---------------------
2018-2022 2018-2027
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Outlays:
Discretionary programs:
Defense............................................... 3.2% 3.1% 3.2% 3.2% 3.0% 2.9% 2.7% 2.6% 2.5% 2.5% 2.4% 2.3% 3.0% 2.7%
Non-defense........................................... 3.3 3.2 3.0 2.7 2.4 2.2 2.0 1.8 1.7 1.6 1.5 1.4 2.5 2.0
---------------------------------------------------------------------------------------------------------------------------------
Subtotal, discretionary programs.................. 6.4 6.3 6.2 5.9 5.5 5.1 4.7 4.4 4.2 4.0 3.9 3.7 5.5 4.8
Mandatory programs:
Social Security....................................... 4.9 4.9 5.0 5.1 5.2 5.2 5.3 5.3 5.4 5.5 5.5 5.6 5.2 5.3
Medicare.............................................. 3.2 3.1 2.9 3.1 3.2 3.3 3.5 3.5 3.4 3.6 3.7 3.8 3.2 3.4
Medicaid.............................................. 2.0 2.0 2.0 2.0 2.0 2.0 1.9 1.9 1.8 1.8 1.8 1.7 2.0 1.9
Other mandatory programs.............................. 3.0 3.4 2.8 2.9 2.8 2.7 2.7 2.6 2.4 2.4 2.3 2.2 2.8 2.6
Allowance for Obamacare repeal and replacement........ ....... ....... -0.1 -0.1 -0.4 -0.6 -0.6 -0.6 -0.6 -0.6 -0.6 -0.6 -0.4 -0.5
Allowance for infrastructure initiative............... ....... ....... * 0.1 0.2 0.2 0.2 0.1 * * * ....... 0.1 0.1
---------------------------------------------------------------------------------------------------------------------------------
Subtotal, mandatory programs...................... 13.2 13.4 12.7 13.1 12.9 12.8 13.0 12.7 12.5 12.6 12.7 12.6 12.9 12.8
Net interest.......................................... 1.3 1.4 1.6 1.8 1.9 2.1 2.2 2.2 2.2 2.2 2.1 2.1 1.9 2.0
---------------------------------------------------------------------------------------------------------------------------------
Total outlays..................................... 20.9 21.2 20.5 20.7 20.3 20.0 19.9 19.4 18.9 18.9 18.7 18.4 20.3 19.6
Receipts:
Individual income taxes................................... 8.4 8.7 9.2 9.2 9.3 9.4 9.5 9.5 9.6 9.7 9.8 9.9 9.3 9.5
Corporation income taxes.................................. 1.6 1.7 1.8 1.8 1.8 1.7 1.7 1.7 1.6 1.6 1.6 1.6 1.8 1.7
Social insurance and retirement receipts:
Social Security payroll taxes......................... 4.4 4.5 4.5 4.4 4.4 4.4 4.5 4.4 4.4 4.4 4.5 4.4 4.4 4.4
Medicare payroll taxes................................ 1.3 1.3 1.4 1.4 1.4 1.4 1.4 1.4 1.4 1.4 1.4 1.4 1.4 1.4
Unemployment insurance................................ 0.3 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2
Other retirement...................................... 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1
Excise taxes.............................................. 0.5 0.5 0.5 0.5 0.5 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.5 0.4
Estate and gift taxes..................................... 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1
Customs duties............................................ 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2
Deposits of earnings, Federal Reserve System.............. 0.6 0.5 0.4 0.3 0.2 0.2 0.3 0.3 0.3 0.3 0.3 0.3 0.3 0.3
Other miscellaneous receipts.............................. 0.2 0.3 0.3 0.3 0.3 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.3 0.2
Allowance for Obamacare repeal and replacement............ ....... ....... -0.3 -0.3 -0.4 -0.4 -0.4 -0.5 -0.4 -0.4 -0.4 -0.4 -0.4 -0.4
---------------------------------------------------------------------------------------------------------------------------------
Total receipts........................................ 17.8 18.1 18.3 18.2 18.1 18.0 18.1 18.1 18.2 18.2 18.3 18.4 18.1 18.2
---------------------------------------------------------------------------------------------------------------------------------
Deficit/surplus (-)........................................... 3.2 3.1 2.2 2.5 2.2 2.0 1.8 1.3 0.8 0.6 0.4 -0.1 2.1 1.4
Net interest.............................................. 1.3 1.4 1.6 1.8 1.9 2.1 2.2 2.2 2.2 2.2 2.1 2.1 1.9 2.0
Primary deficit/surplus (-)............................... 1.9 1.7 0.6 0.7 0.3 -0.1 -0.4 -1.0 -1.4 -1.6 -1.8 -2.1 0.2 -0.7
On-budget deficit/surplus (-)............................. 3.4 3.4 2.3 2.5 2.1 1.9 1.6 1.0 0.4 0.2 -0.1 -0.6 2.1 1.1
Off-budget deficit/surplus (-)............................ -0.2 -0.2 -0.1 -* 0.1 0.1 0.2 0.3 0.3 0.4 0.5 0.5 * 0.2
Memorandum, budget authority for discretionary programs:
Defense................................................... 3.3 3.4 3.3 3.2 3.0 2.9 2.7 2.7 2.6 2.5 2.4 2.4 3.0 2.8
Non-defense............................................... 3.0 2.8 2.4 2.2 2.0 1.9 1.7 1.6 1.5 1.4 1.3 1.2 2.0 1.7
---------------------------------------------------------------------------------------------------------------------------------
Total, discretionary funding.......................... 6.3 6.2 5.7 5.4 5.1 4.7 4.5 4.3 4.1 3.9 3.7 3.6 5.1 4.5
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
*0.05 percent of GDP or less.
Table S-6. Mandatory and Receipt Proposals
(Deficit increases (+) or decreases (-) in millions of dollars)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Totals
2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 -------------------------
2018-2022 2018-2027
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Other Independent Agencies:
Federal Communications Commission:
Enact Spectrum License User Fee...... ......... -$50 -$150 -$300 -$450 -$500 -$500 -$500 -$500 -$500 -$500 -$1,450 -$3,950
Reform the Postal Service................ ......... -2,807 -4,685 -4,871 -4,791 -4,923 -4,904 -4,913 -4,795 -4,676 -4,655 -22,077 -46,020
Restructure the Consumer Financial ......... -145 -650 -683 -706 -726 -745 -764 -784 -804 -826 -2,910 -6,833
Protection Bureau.......................
Eliminate the Securities and Exchange ......... ......... -50 -50 -50 -50 -50 -50 -50 -50 -50 -200 -450
Commission Reserve Fund.................
Mandatory effects of agency eliminations. ......... 1 ......... ......... ......... -1 ......... ......... ......... ......... ......... ........... ...........
--------------------------------------------------------------------------------------------------------------------------------------------------
Total, Other Independent Agencies.... ......... -3,001 -5,535 -5,904 -5,997 -6,200 -6,199 -6,227 -6,129 -6,030 -6,031 -26,639 -57,255
Cross-cutting reforms:
Repeal and replace Obamacare............. ......... 25,000 30,000 -5,000 -30,000 -35,000 -40,000 -40,000 -50,000 -50,000 -55,000 -15,000 -250,000
Implement an infrastructure initiative... ......... 5,000 25,000 40,000 50,000 40,000 20,000 10,000 5,000 5,000 ......... 160,000 200,000
Reform welfare programs:
Reform Supplemental Nutrition ......... -4,637 -7,627 -13,990 -16,928 -21,130 -24,871 -24,634 -25,714 -26,135 -25,266 -64,312 -190,932
Assistance Program (SNAP)...........
Establish a SNAP authorized retailer ......... -252 -246 -241 -236 -230 -230 -230 -230 -230 -230 -1,205 -2,355
application fee.....................
Eliminate SSBG....................... ......... -1,411 -1,683 -1,700 -1,700 -1,700 -1,700 -1,700 -1,700 -1,700 -1,700 -8,194 -16,694
Reduce Temporary Assistance for Needy ......... -1,218 -1,491 -1,550 -1,582 -1,615 -1,632 -1,632 -1,632 -1,632 -1,632 -7,456 -15,616
Families (TANF) block grant.........
Provide funding for welfare research ......... ......... ......... ......... ......... ......... ......... ......... ......... ......... ......... ........... ...........
and Census Bureau Survey of Income
and Program Participation,
transferred from TANF...............
Eliminate TANF Contingency Fund...... ......... -567 -608 -608 -608 -608 -608 -608 -608 -608 -608 -2,999 -6,039
Require Social Security Number (SSN) ......... -449 -4,512 -4,447 -4,358 -4,309 -4,296 -4,373 -4,460 -4,555 -4,652 -18,075 -40,411
for Child Tax Credit and Earned
Income Tax Credit...................
--------------------------------------------------------------------------------------------------------------------------------------------------
Total, reform welfare programs... ......... -8,534 -16,167 -22,536 -25,412 -29,592 -33,337 -33,177 -34,344 -34,860 -34,088 -102,241 -272,047
Reform disability programs and test new
approaches:
Test new approaches to increase labor ......... 100 100 100 100 100 -2,494 -5,069 -9,332 -13,809 -18,627 500 -48,831
force participation.....................
Reinstate the reconsideration review ......... ......... 71 -10 -59 -526 -246 -263 -305 -354 -376 -524 -2,068
stage in 10 States......................
Reduce 12 month retroactive Disability ......... -113 -643 -797 -951 -1,043 -1,112 -1,191 -1,272 -1,349 -1,430 -3,547 -9,901
Insurance benefits to 6 months..........
Create sliding scale for multi-Precipient ......... -743 -827 -861 -882 -956 -906 -862 -955 -979 -1,002 -4,269 -8,973
Supplemental Security Income families...
Create a probationary period for ......... ......... ......... ......... ......... ......... ......... ......... ......... ......... ......... ........... ...........
Administrative Law Judges (ALJs)........
Eliminate Workers Compensation Reverse ......... ......... -3 -8 -12 -16 -19 -22 -25 -28 -31 -39 -164
Offsets.................................
Offset overlapping unemployment and ......... ......... -58 -249 -329 -324 -319 -323 -323 -296 -317 -960 -2,538
disability payments.....................
--------------------------------------------------------------------------------------------------------------------------------------------------
Total, reform disability programs and ......... -756 -1,360 -1,825 -2,133 -2,765 -5,096 -7,730 -12,212 -16,815 -21,783 -8,839 -72,475
test new approaches.................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
______
BBC News
Pharmaceutical Industry Gets High on Fat Profits
By Richard Anderson, business reporter
November 6, 2014
Imagine an industry that generates higher profit margins than any other
and is no stranger to multi-billion dollar fines for malpractice.
Throw in widespread accusations of collusion and over-charging, and
banking no doubt springs to mind.
In fact, the industry described above is responsible for the
development of medicines to save lives and alleviate suffering, not the
generation of profit for its own sake.
Pharmaceutical companies have developed the vast majority of medicines
known to humankind, but they have profited handsomely from doing so,
and not always by legitimate means.
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Last year, U.S. giant Pfizer, the world's largest drug company by
pharmaceutical revenue, made an eye-watering 42% profit margin. As one
industry veteran understandably says: ``I wouldn't be able to justify
[those kinds of margins].''
Stripping out the one-off $10bn (6.2bn) the company made
from spinning off its animal health business leaves a margin of 24%,
still pretty spectacular by any standard.
In the UK, for example, there was widespread anger when the industry
regulator predicted energy companies' profit margins would grow from 4%
to 8% this year.
Last year, five pharmaceutical companies made a profit margin of 20% or
more--Pfizer, Hoffmann-La Roche, AbbVie, GlaxoSmithKline (GSK) and Eli
Lilly.
``Profiteering''
With some drugs costing upwards of $100,000 for a full course, and with
the cost of manufacturing just a tiny fraction of this, it's not hard
to see why.
Last year, 100 leading oncologists from around the world wrote an open
letter in the journal Blood calling for a reduction in the price of
cancer drugs.
Dr. Brian Druker, director of the Knight Cancer Institute and one of
the signatories, has asked: ``If you are making $3bn a year on [cancer
drug] Gleevec, could you get by with $2bn? When do you cross the line
from essential profits to profiteering?''
And it's not just cancer drugs--between April and June this year, drug
company Gilead clocked sales of $3.5bn for its latest blockbuster
hepatitis C drug Sovaldi.
Drug companies justify the high prices they charge by arguing that
their research and development (R&D) costs are huge. On average, only
three in 10 drugs launched are profitable, with one of those going on
to be a blockbuster with $1bn-plus revenues a year. Many more do not
even make it to market.
But as the table below shows, drug companies spend far more on
marketing drugs--in some cases twice as much--than on developing them.
And besides, profit margins take into account R&D costs.
World's Largest Pharmaceutical Firms
Total Sales and
Company revenue R&D spend marketing Profit Profit
($bn) ($bn) spend ($bn) ($bn) margin (%)
Johnson $71.3 $8.2 $17.5 $13.8 19%
and
Johnso
n
(U.S.)
Novarti 58.8 9.9 14.6 9.2 16
s
(Swiss
)
Pfizer 51.6 6.6 11.4 22.0 43
(U.S.)
Hoffman 50.3 9.3 9.0 12.0 24
n-La
Roche
(Swiss
)
Sanofi 44.4 6.3 9.1 8.5 11
(Franc
e)
Merck 44.0 7.5 9.5 4.4 10
(U.S.)
GSK 41.4 5.3 9.9 8.5 21
(UK)
AstraZe 25.7 4.3 7.3 2.6 10
neca
(UK)
Eli 23.1 5.5 5.7 4.7 20
Lilly
(U.S.)
AbbVie 18.8 2.9 4.3 4.1 22
(U.S.)
Source: GlobalData.
The industry also argues that the wider value of the drug needs to be
considered.
``Drugs do save money over the longer term,'' says Stephen Whitehead,
chief executive of the Association of the British Pharmaceuticals
Industry (ABPI).
``Take hepatitis C, a shocking virus that kills people and used to
require a liver transplant. At 35,000 [to
70,000] for a 12-week course, 90% of people are now cured,
will never need surgery or looking after, and can continue to support
their families.
``The amount of money saved is huge.''
True, but just because you can charge a high price for something does
not necessarily mean you should, especially when it comes to health,
critics such as Dr. Druker might say. Shareholders, who big pharma
companies ultimately have to answer to, would have little time for such
an argument.
No loyalty
Big pharma companies also say they only have a limited time in which to
make profits. Patents are generally awarded for 20 years, but 10-12 of
those are typically spent developing the drug at a cost of about
$1.5bn-$2.5bn.
This leaves 8 to 10 years to make money before the formula can be taken
up by generic drug companies, which sell the medicines for a fraction
of the price.
Once this happens, sales fall by 90%-plus. As Joshua Owide, director of
healthcare industry dynamics at research company GlobalData, explains,
``Unlike other sectors, brand loyalty goes out the window when patents
expire.''
This is why pharma companies go to such extraordinary lengths to extend
their patent--a process known as evergreening--employing ``floors full
of lawyers'' for this express purpose, one industry insider says.
For a drug raking in $3bn a quarter, even a one-month extension can be
worth huge sums of money.
New formulations, combining two existing drugs to give a wider use, and
enantiomers--a mirror image of the same compound--are some of the legal
ways to eke out patents. But some drug companies, including the UK's
GSK, have been accused of more underhand tactics, such as paying
generics to delay the release of their cheaper alternatives.
As the loss of sales at the big pharma companies far outweighs the
revenue made by the generics, this can be an attractive arrangement for
both parties.
Courting doctors
But drug companies have been accused of, and admitted to, far worse.
Until recently, paying bribes to doctors to prescribe their drugs was
commonplace at big pharmas, although the practice is now generally
frowned upon and illegal in many places. GSK was fined $490m in China
in September for bribery and has been accused of similar practices in
Poland and the Middle East.
The rules on gifts, educational grants and sponsoring lectures, for
example, are less clear cut, and these practices remain commonplace in
the United States.
Indeed a recent study found that doctors in the United States receiving
payments from pharma companies were twice as likely to prescribe their
drugs.
This may well exacerbate the problem of overspending on drugs by
governments. A recent study by Prescribing Analytics suggested that the
UK's National Health Service could save up to 1bn a year by
doctors switching from branded to equally effective generic versions of
the drugs.
Big pharmaceutical fines
$3bn--Glaxo SmithKline, 2012, over promoting Paxil for depression to
under-18s
$2.3bn--Pfizer, 2009, over misbranding painkiller Bextra
$2.2bn--Johnson and Johnson, 2013, for promoting drugs not approved as
safe
$1.5bn--Abbott, 2012, over illegal promotion of antipsychotic drug
Depakote
$1.42bn--Eli Lilley, 2009, for wrongly promoting antipsychotic drug
Zyprexa
$950m--Merck, 2011, for illegally promoting painkiller Vioxx
SOURCE: PROPUBLICA
This all may change when new rules in the United States and UK will
force doctors to disclose all gifts and payments made by the industry.
Drug companies have also been accused of colluding with chemists to
overcharge for their medicines and of publishing trial data that
highlight the positive at the expense of the negative.
They have also been found guilty of mis-branding and wrongly promoting
various drugs, and have been fined billions as a result.
The rewards are so great, it would seem, that pharma companies have
continually been prepared to push the boundaries of legality.
Undue influence
No wonder, then, that the World Health Organisation (WHO) has talked of
the ``inherent conflict'' between the legitimate business goals of the
drug companies and the medical and social needs of the wider public.
Indeed the Council of Europe is launching an investigation into
``protecting patients and public health against the undue influence of
the pharmaceutical industry.''
It will look at ``particular practices such as sponsoring health
professionals by the industry . . . or recourse by public health
institutions to the knowledge of highly specialised researchers on the
pay-rolls of industry.''
No matter what the outcome of such investigations, however, the
pharmaceutical industry is facing fundamental change, as the
traditional model of developing drugs breaks down due to rising costs
and scientific advances.
The cosy world of big pharmaceuticals is under threat like never
before.
This is the first in a two-part series on pharmaceutical companies. The
second looks at how and why fundamental change will take place in the
industry.
______
Communications
----------
The AIDS Institute
1705 DeSales Street, NW, Suite 700
Washington, DC 20036
Dear Chairman Hatch and Committee Members:
We write to submit a written statement for the record for the January
9, 2018 hearing to consider the nomination of Alex Azar to serve as
Secretary of Health and Human Services.
As both a former HHS Deputy Secretary and General Counsel, together
with his private sector experience, Alex Azar has the knowledge,
expertise, and leadership to oversee our Nation's health response.
While we may not share some of the Trump administration's objectives
relative to such issues as the Affordable Care Act and Medicaid, we
believe a practical problem-solver like Mr. Azar is the right person
for the job for this administration. He has been a dedicated public
servant with additional leadership in the health industry who
understands the importance of meeting the health needs of patients. He
also values the role of the patient voice in decision making.
The AIDS Institute looks forward to Senate consideration of the
nomination and hearing more details from Mr. Azar on how HHS, under his
stewardship, will lead our Nation's efforts to eliminate HIV and
hepatitis and address other health issues. We hope the confirmation
process will occur without delay in order to quickly fill the current
leadership gap at HHS.
Sincerely,
Carl Schmid
Deputy Executive Director
______
AIDS United
1101 14 Street, NW, Suite 300
Washington, DC 20005
(202) 408-4848
www.aidsunited.org
Questions for Mr. Alex Azar, Secretary,
Department of Health and Human Services
Do you believe that religious organizations should be able to receive
funding from HHS to provide health care and discriminate on the basis
of sexual orientation and gender identity in providing that service or
in hiring staff to provide that service?
What is your vision for Medicare and Medicaid? We have long heard of
this Administration's and Congress's interest in entitlement reform,
including block-granting Medicaid, adding work requirements and other
parameters that will necessarily impede Medicaid eligibility, and
altering Medicare eligibility, all with the goal of not just reducing
spending on Medicaid and Medicare, but reducing access to high-
quality health care through the programs. Why not, for example, instead
continue to focus on value-based service delivery and financing options
as a way to ensure high quality outcomes and incentivize efficient and
effective providers of services?
Will you continue to promote ``state flexibility'' in administration of
Medicaid programs? This is code for allowing states to tinker with
Medicaid's entitlement status at the state level and only serves to
reduce Medicaid rolls. We know that the Medicaid benefit package is
robust, state Medicaid programs' administrative overhead percentage is
much lower than commercial plans, and beneficiaries receive care in
lower acuity settings that oftentimes avoids higher cost settings. Why
would you allow states to change this model?
Mr. Azar, what is your perspective on the high cost of pharmaceuticals
in the U.S. in comparison to other countries in North America and the
rest of the developing world? President Trump has expressed interest in
lowering consumer drug prices and I'd like to hear what you plan to do
as HHS Secretary and as the former Eli Lilly CEO to address these
concerns.
Mr. Azar, the Presidential Advisory Council on HIV and AIDS has played
an important role in advising the President through the Secretary of
HHS on sound HIV health policy since the early 1990s. The Council
membership was recently removed, and we await a new set of council
members. How will you ensure a diverse and representative membership?
HHS has an essential role in the stabilization of the health insurance
marketplaces, the affordability of health insurance, and the
accessibility of high quality health care services for Americans. How
will you address these priorities?
The Center for Medicaid and Medicare Services plays an essential role
in ensuring health-care access and long term care for the disabled, the
elderly and low-income individuals through Medicaid and Medicare.
Medicaid remains the essential provider of HIV related health-care
services in the U.S. HIV advocates are concerned that the commitment to
this essential role and the many associated responsibilities have been
called into question by recent rules that threaten to diminish state's
responsibilities to provide these services to all who are currently
eligible. What will you do to ensure that these safety net services
remain available to low income and underserved populations?
If any further information is needed regarding these questions, please
contact AIDS United's Director of Government Affairs, Mr. Carl Baloney,
Jr., at cbaloney@aids
united.org or (202) 876-2818.
______
Bassuk Center on Homeless and Vulnerable Children and Youth, et al.
January 5, 2018
The Honorable Orrin Hatch The Honorable Ron Wyden
Chairman Ranking Member
U.S. Senate U.S. Senate
Committee on Finance Committee on Finance
219 Dirksen Senate Office Bldg. 219 Dirksen Senate Office Bldg.
Washington, DC 20510 Washington, DC 20510
RE: Hearing to consider the anticipated nomination of Alex Azar to
serve as the Department of Health and Human Services (HHS) Secretary
Dear Chairman Hatch and Ranking Member Wyden:
The undersigned organizations appreciate the opportunity to submit
questions for the hearing of Alex Azar as Secretary of the U.S. Health
and Human Services (HHS). The scope of our organizations vary, but we
share the common goal of ending homelessness and recognize the
importance of access to health care in order to accomplish this goal.
HHS is the principle agency responsible for providing essential human
services to those who are least able to help themselves. Given the
strong connection between homelessness and health we request the
following questions be posed to Alex Azar during his hearings for HHS
Secretary.
1. Medicaid and the uninsured: Even with large expansions under the
Affordable Care Act (ACA), 29 million Americans still are uninsured.
Predictably, those without insurance experience disproportionate
amounts of homelessness, chronic health conditions, and incur high
medical costs due to ER visits and poor health. At the same time, the
Administration has supported numerous attempts to repeal the ACA, with
a specific goal of undermining the expansion of Medicaid to single
adults without dependent children. This provision was particularly
important for those experiencing homelessness and the health-care
providers who serve them, and has facilitated wider access to life-
saving care. As HHS Secretary, how will new policies ensure coverage
will not be lost to those who already gained it under the ACA's
Medicaid expansion, and how will you broaden access to health coverage
to reach those who remain uninsured?
2. Housing: Stable housing is a key social determinant of health. Poor
health causes and prolongs homelessness, the experience of homelessness
exacerbates existing health conditions, and lack of housing makes it
more difficult to engage in health-care services. Research shows that
once an individual gains stable housing they are better able to address
health-care problems and attain better outcomes, producing cost savings
in the process. As HHS Secretary, how do you plan to incorporate social
determinants of health, like unstable housing, into the health-care
system? How do you see your budget as directly impacted by other
Administration budgets like that of Housing and Urban Development
(HUD), Education, and/or Labor?
3. Homelessness: The most recent Annual Homeless Assessment Report
estimated nearly 1.5 million people experienced homelessness in the
United States in 2015. Many of these individuals have significant
health-care issues, such as chronic illness and mental health and
addiction disorders. As Secretary, what role do you believe HHS has to
help prevent and end homelessness?
4. Costs of Prescription Drugs: As head of the U.S. division of
pharmaceutical giant Eli Lilly and Co., Mr. Azar knows a great deal
about the cost of prescription drugs, which are a significant portion
of Medicaid budgets as well as a barrier to accessing health care for
many people who are poor and uninsured and unable to afford medication.
As Secretary, how will you commit to lowering the cost of prescription
drugs so there is less burden on states and local communities, as well
as for low-income individuals?
5. Rural Areas: Low-income Americans living in rural areas often live
too far away from health providers to receive regular and comprehensive
care. This is especially true of mental health and addiction treatment
where too few providers exist, and far too few accept Medicaid. Rural
hospitals and other safety net providers are especially struggling. Low
reimbursements, high rates of poverty, and remote working conditions
are significant disincentives to recruit and retain a trained health-
care workforce. How do you envision solving this problem?
6. Employment: Health insurance coverage helps pay for the health care
needed to maintain health. Good health is the basis for a healthy and
able workforce. For individuals experiencing homelessness, policies
that make access to health care dependent on working only serve as a
barrier to both work and health care. As HHS Secretary, what is your
position on work requirements, and how do you anticipate navigating
proposed barriers to care like work requirements, time limits on
Medicaid benefits, drug testing, and other provisions that will deny
coverage to vulnerable people?
Thank you for considering any or all of these questions related to
homelessness and health care during hearings for Alex Azar. If you
would like to talk further about how health care is critical for the
needs of people who are homeless, please contact Regina Reed, Policy
Organizer at the National Health Care for the Homeless Council, at 443-
703-1337.
Sincerely,
Bassuk Center on Homeless and Vulnerable Children and Youth
Community Solutions
Family Promise
National Alliance to End Homelessness
National Coalition for the Homeless
National Health Care for the Homeless Council
National Law Center on Homelessness and Poverty
National Low Income Housing Coalition
National Network to End Domestic Violence
Technical Assistance Collaborative
Western Regional Advocacy Project
Association for Utah Community Health (UT)
Care for the Homeless (NY)
Central City Concern (OR)
Circle the City (AZ)
Colorado Coalition for the Homeless (CO)
Health Care for the Homeless (MD)
Mercy Care (GA)
Unity Health Care, Inc. (DC)
Urban Pathways (NY)
______
Letter Submitted by Alison Michelle Ernst
January 5, 2018
U.S. Senate
Committee on Finance
Dirksen Senate Office Building
Washington, DC 20510-6200
While one can argue Mr. Azar is well qualified to be the Secretary of
Health and Human Services Department, I will argue his background
tethers him to the status quo and to dangerous paradigms which will not
allow the Department of Health and Human Services to function as
efficiently as we need it to, and to its fullest capabilities which all
our lives depend upon.
Mr. Azar's career path informs us being a dedicated advocate for the
health and welfare of the public has not been his priority. He served
as the United States Deputy Secretary of Health and Human Services
between 2005 and 2007 when the opioid epidemic was hitting hard and
spiking fast. Yet he resigned from a key position from which to have an
impact to become a pharmaceutical company lobbyist and then an
executive. In 2009, ``under Azar, Eli Lilly and Company paid $1.415
billion to settle criminal charges regarding its promotion of
antipsychotic drug Zyprexa for off-label uses.''
We are at a critical fork in the road; pharmaceutical giants are
covertly interfering in ways most of you cannot begin to imagine or
comprehend. Confirming Azar will undoubtedly take us down an
unfortunate path.
An excerpt from a letter I sent to Attorney General Hembree:
As you battle the opioid epidemic, I want to alert you to a
seemingly small piece of the puzzle, that big pharmaceutical
companies have a stake in the health care and drug treatment
industries overlooking or being ``willfully'' blind to.
Opiate consumption and addiction is fueled by of an unnatural
overabundance of endocrine disrupting compounds in the form of
dangerous heavy metal toxins. The EPA tracks some Superfund
Sites while many go undesignated. Just mild exposure to
dangerous heavy metal toxins decreases our production of the
most basic hormones which enable us to have stable moods, and a
natural tolerance for pain. People are craving opioids ``per
se'' often because exposure to dangerous heavy metals makes it
difficult for us to simply feel ``happy,'' pain-free, and
``strong.''
Basic physicals or even more extensive health exams rarely if
ever screen for exposure to dangerous heavy metals. A
preventative measure to decrease one's susceptibility to opioid
addiction is for individuals to, as a precaution, treat the
body and brain for exposure to dangerous heavy metals. The
beauty is the treatment offers basic health benefits to the
immune system even if one has not been exposed to dangerous
heavy metals. The treatment includes small daily doses of
selenium, magnesium and zinc to dislodge dangerous heavy
metals, and Alpha Lipoic Acid to clear them from the body and
brain. The treatment costs almost nothing.
I challenge you to consider posing the following questions to Azar.
Are you aware that United States Superfund Sites are the number one
enemy of the health and welfare of United States citizens?
Are you aware that pharmaceutical companies greatly profit from
Superfund Sites not being cleaned up?
Can we trust you to head the Department of Health and Human Services as
an individual who has benefited from the profits of pharmaceutical
companies at a cost to the public health and welfare?
As we face questions and dilemmas about Obamacare, Medicare, and
Medicaid, I, as the Secretary of the Health and Human Services
Department will make it my priority to improve the overall health of
the public, therefore safety nets as they are intended to be, can serve
their purpose efficiently and not be overburdened.
One of the paradigm shifts entails admitting profits are being made
from people not being well. It is a hard one to swallow, I know.
Further, I have also compiled a large body of work which explores the
subconscious coding of extreme events of violence which alerts us to
larger truths. My latest attempt to prove my theory includes an
analysis of what the neuropathologist Dr. Hannes Vogel may discover is
affecting the brain of Stephen Paddock. We still await Dr. Vogel's
results to be made public. I learned early in my career as a social
worker for the City of Phoenix Human Services Department that we cannot
solve problems by being so quick to deem individuals deficient. To find
solutions, we must look further, explore many possibilities, variables
and factors. Too many men today pride themselves on being experts and
having the answers because somehow even misinformation has become a
commodity.
The entire United States health-care system is a failing structure
rigged on the faulty foundation of profiteering. I have the energy to
guide the Department of Health and Human Services to be an engine that
drives this Nation in the direction it needs to go. Right now, the
state of the health and wellness of the people of the United States, is
a threat to global security. In addition to an overabundance of
dangerous heavy metals affecting our ability to have stable moods, be
generally happy and pain free, these endocrine disrupting compounds,
are hindering our basic human capacity to be kind, nurturing and
loving.
I am asking you to vote no on Alex Azar's nomination. I am asking you
to sway President Trump to nominate me, Alison Michelle Ernst.
And with this document I declare my covert operations which entailed a
broad investigation of many divisions and programs across the
Department of Health and Human Services officially over.
Azar technically was involved in attempting to increase profits for a
pharmaceutical giant by victimizing those that the Department of Health
and Human Services has a primary duty to protect, ``those who are least
able to protect themselves.'' I on the other hand, risked everything to
witness and understand the unbelievable horrors which our most
vulnerable our experiencing.
I ask whole heartedly for your consideration,
Alison Michelle Ernst
______
Hansa Center for Optimum Health
12219 E. Central Avenue
Wichita, KS 67206
Statement of Dr. David Jernigan, Founder
U.S. Senate
Committee on Finance
219 Dirksen Senate Office Building
Washington, DC 20510-6200
Chairman Hatch, Senator Wyden, and members of the committee:
Thank you for the opportunity to submit a statement on the nomination
of Alex Azar to the position of Secretary of Health and Human Services.
America's addiction to pain pills was entirely predictable. The nation
has long been over-medicated, blithely popping 3.2 billion medications
annually, according to the CDC.
Watch any nightly network newscast and we're bombarded with drug ads,
playing on our myriad health concerns and promising blissful remedies.
Harvard tells us that the drug industry spends more than $5 billion a
year on consumer advertising, supporting, according to the U.S.
Government, more than $300 billion in pharmaceutical sales. Add to that
the astronomical popularity of non-prescription or OTC drug products,
and you can see that we're a nation consumed by our aches and pills.
Given this environment, it is somewhat concerning that the nominee for
Secretary of Health and Human Services, whose job is to protect
Americans' health, is the former president of the U.S. division of
global pharmaceutical marketer Eli Lilly and Company. His disposition
towards expanding our synthetic drug culture versus furthering the
development and application of natural medicine should be carefully
explored during Congress's consideration of his nomination.
While many pharmaceuticals clearly can save, extend and improve the
quality of life, the reality is that their long-term use conveys merely
the illusion of health. Remission is promoted as success, even though
it is but a temporary abatement of symptoms. While Americans consume
the most prescription medications, the World Health Organization ranks
the U.S. as having the worst health among developed countries. With
drugs to control the symptoms of every named illness, Americans are
oblivious to the reality that despite their pills, they're getting
sicker.
A vital key to a healthier and more productive population is the
development and promotion of a new medical corps, trained in the pure
treatment philosophy of biological medicine, focused on identifying and
treating the root causes of illness, rather than just the symptoms.
True healing cannot occur by simply masking symptoms. In those
instances where pharmaceuticals are required as first-line treatment,
the aim should be to get off medication as quickly as possible, and
identify and correct the cause at its source.
The biological medicine treatment option is particularly effective for
those with chronic pain and illness--cases that have been considered
untreatable in conventional drug therapy--without the risk of addiction
or worse. It applies advanced science in diagnostics and treatment
technologies to treat the patient, not the disease, by restoring the
body's own healing potential.
Lifetime reliance on pharmaceutical drugs only benefits the drug
industry. While prescription drugs are convenient, requiring little
time and effort to prescribe, symptom-suppression is not a real
solution to health problems, and it often entails side effects that
reduce productivity and ultimately lower quality of life.
Americans should demand that our health-care providers, elected
officials and industry regulators acknowledge the drug industry's grip
on our health-care system, and work to recognize and promote natural
treatments and disciplines that seek to restore health, versus
continuing promotion of the drug-induced illusion of health. The
confirmation process for HHS Secretary-designate Azar is a prime
opportunity to start this process.
David A. Jernigan, D.C.
Dr. Jernigan is a nationally recognized leader, author and lecturer in
Biological Medicine and the treatment of chronic illness. Graduating
from Park University with a bachelor of science in Nutrition with
honors, he received his doctorate in Chiropractic Medicine at Cleveland
University, Kansas City. His postgraduate work has included the study
of natural and anthroposophical medicine in Germany and of Biological
Medicine with Thomas Rau, M.D. of Switzerland's Paracelsus Clinic. Dr.
Jernigan received his certification in Botanical Medicine from the
University of Colorado School of Pharmacy. He is the developer of the
diagnostic and treatment techniques Bio-Resonance
ScanningTM, NeuroCardial SynchronizationTM, and
NeuroPhotonic TherapyTM. Dr. Jernigan has developed over 30
novel natural medicines to date, and authored four books on the natural
treatment of People diagnosed with Lyme disease; his latest is Beating
Lyme Disease; Living the Good Life in Spite of Lyme, 2nd edition. The
founder of the Hansa Center, Dr. Jernigan is one of the most
experienced doctors in the United States in the FDA-cleared adjunctive
diagnostic tests, Alfa and Computerized Regulation Thermodiagnostics.
[email protected] (316) 686-5900
www.HansaCenter.com
The preceding statement was originally published in the National Pain
Report on December 23, 2017.
[all]