[Senate Hearing 111-804]
[From the U.S. Government Publishing Office]
S. Hrg. 111-804
NOMINATION OF GOVERNOR KATHLEEN SEBELIUS
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
ON
NOMINATION OF GOVERNOR KATHLEEN SEBELIUS, OF KANSAS, TO BE SECRETARY,
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
__________
MARCH 31, 2009
__________
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
EDWARD M. KENNEDY, Massachusetts, Chairman
CHRISTOPHER J. DODD, Connecticut MICHAEL B. ENZI, Wyoming
TOM HARKIN, Iowa JUDD GREGG, New Hampshire
BARBARA A. MIKULSKI, Maryland LAMAR ALEXANDER, Tennessee
JEFF BINGAMAN, New Mexico RICHARD BURR, North Carolina
PATTY MURRAY, Washington JOHNNY ISAKSON, Georgia
JACK REED, Rhode Island JOHN McCAIN, Arizona
BERNARD SANDERS (I), Vermont ORRIN G. HATCH, Utah
SHERROD BROWN, Ohio LISA MURKOWSKI, Alaska
ROBERT P. CASEY, JR., Pennsylvania TOM COBURN, M.D., Oklahoma
KAY R. HAGAN, North Carolina PAT ROBERTS, Kansas
JEFF MERKLEY, Oregon
J. Michael Myers, Staff Director and Chief Counsel
Frank Macchiarola, Republican Staff Director and Chief Counsel
(ii)
C O N T E N T S
__________
STATEMENTS
TUESDAY, MARCH 31, 2009
Page
Kennedy, Hon. Edward M., Chairman, Committee on Health,
Education, Labor, and Pensions, opening statement.............. 1
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming,
opening statement.............................................. 2
Prepared statement........................................... 3
Roberts, Hon. Pat, a U.S. Senator from the State of Kansas....... 5
Prepared statement........................................... 6
Baker, Hon. Nancy Kassebaum, a U.S. Senator from the State of
Kansas, prepared statement..................................... 7
Dole, Hon. Robert J., Former U.S. Senator from the State of
Kansas......................................................... 7
Prepared statement........................................... 10
Brown, Hon. Sherrod, a U.S. Senator from the State of Ohio....... 12
Sebelius, Kathleen, Governor, State of Kansas, Topeka, KS........ 13
Prepared statement........................................... 16
Mikulski, Hon. Barbara A., a U.S. Senator from the State of
Maryland....................................................... 23
Isakson, Hon. Johnny, a U.S. Senator from the State of Georgia... 25
Harkin, Hon. Tom, a U.S. Senator from the State of Iowa.......... 27
McCain, Hon. John, a U.S. Senator from the State of Arizona...... 29
Murray, Hon. Patty, a U.S. Senator from the State of Washington.. 30
Coburn, Hon. Tom, a U.S. Senator from the State of Oklahoma...... 32
Dodd, Hon. Christopher J., a U.S. Senator from the State of
Connecticut.................................................... 34
Prepared statement........................................... 35
Murkowski, Hon. Lisa, a U.S. Senator from the State of Alaska.... 39
Reed, Hon. Jack, a U.S. Senator from the State of Rhode Island... 41
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina....................................................... 42
Sanders, Hon. Bernard, a U.S. Senator from the State of Vermont.. 44
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of
Pennsylvania................................................... 48
ADDITIONAL MATERIAL
Response by Kathleen Sebelius to questions of:
Senator Kennedy.............................................. 53
Senator Harkin............................................... 54
Senator Mikulski............................................. 56
Senator Murray............................................... 57
Senator Reed................................................. 60
Senator Brown................................................ 61
Senator Casey................................................ 62
Senator Hagan................................................ 63
Senator Enzi................................................. 64
Senator Hatch................................................ 75
Senator McCain............................................... 81
Senator Murkowski............................................ 87
Senator Coburn............................................... 90
Senator Burr................................................. 92
Senator Alexander............................................ 95
(iii)
NOMINATION OF GOVERNOR
KATHLEEN SEBELIUS
----------
TUESDAY, MARCH 31, 2009
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10 a.m. in Room
SH-216, Hart Senate Office Building, Hon. Edward M. Kennedy,
Chairman of the committee, presiding.
Present: Senators Kennedy, Dodd, Harkin, Mikulski, Murray,
Reed, Sanders, Brown, Casey, Enzi, Burr, Isakson, McCain,
Murkowski, Coburn, and Roberts.
Opening Statement of Senator Kennedy
The Chairman. We will come to order. We are expecting
Senator Enzi to be here in just a moment or two, but he has
asked us to go ahead, and we shall.
Our hearing today is on the confirmation of Kathleen
Sebelius to serve as the next Secretary of Health.
Few debates in Congress touch our lives as profoundly and
personally as healthcare. Over the past 10 months, I have seen
our healthcare system up close. I have benefited from the best
of medicine.
But we have too many uninsured Americans. We have sickness
care and not healthcare. We have too much bureaucracy--
paperwork and bureaucracy. Costs are out of control.
Today, we have an opportunity like never before to reform
our healthcare, and we need a Secretary of Health who has the
vision, the skill, and the knowledge to help us get there.
Governor Kathleen Sebelius has those traits and more. She was
named one of the five top Governors by Time magazine. She
earned that accolade by reaching across the aisle to find
solutions that worked.
Her Healthy Kansas initiative put thousands of people on
the road to better health. As insurance commissioner and as
Governor, she has been a strong voice for the rights of
patients and consumers.
When it comes to reforming our healthcare system, we know
that challenges are great. I have the confidence that Governor
Sebelius can lead the way with common sense solutions. Although
her duties as Secretary may begin with healthcare reform, they
do not end there. Food safety, drug safety, medical research,
disease prevention--all of these and more have urgent need for
attention. She is the right person for the job, and I strongly
support her nomination.
Governor, we welcome you today and thank you for your
willingness to help serve in this important position.
I know Senator Enzi will be here in just a moment or two. I
will ask that we move ahead then with--ah, there we are.
Senator Enzi. I went to the wrong room.
The Chairman. Good to see you. We have got two arrivals
here, two arrivals. We are doubly blessed this morning.
So we will move ahead with our friend and colleague and
leader, Senator Enzi. We thank you very much for being here.
Statement of Senator Enzi
Senator Enzi. Thank you, Mr. Chairman. It is always good to
have you back, and it's a great day for a hearing.
I would like to begin by thanking you for holding this
hearing today, and I have previously said confirming the
President's nominees is one of the most important
constitutional duties of the Senate. I know that the members of
the committee take the ``Advise and Consent'' clause of the
Constitution seriously.
What we are undertaking today is more of a review of the
nominee's qualifications regarding the substantive issues, if
she is confirmed as Secretary of the Department of Health and
Human Services. It should not be overlooked that the Finance
Committee has the primary jurisdiction over this nomination.
Because of the overlap in our work and the significant role
the Secretary of Health and Human Services will have in the
operations of the Food and Drug Administration, the Centers for
Disease Control, and the National Institutes of Health, the
HELP Committee has established a tradition of holding a hearing
on this important Cabinet-level position.
I would also like to thank Governor Sebelius for joining us
today and for the opportunity to meet with her earlier. I am
hopeful that we will have a strong working relationship, as
will our staff. If confirmed, there are going to be areas where
we disagree, but my hope and expectation is that we will focus
on solutions and, therefore, can produce meaningful results for
the hard-working Americans that meet the test of the 80 percent
rule.
People who have worked with me over time know the 80
percent rule is one of the main rules I always try to follow to
get things done. In applying this rule, I try to focus on the
80 percent of the issues the Senate generally agrees, while not
fixating on the remaining 20 percent, which are divisive and
can sometimes overwhelm the majority of issues that we agree
on.
One area where I hope we can agree on is healthcare reform.
Ensuring access to affordable, quality, and portable healthcare
for every American is not a Republican or a Democrat issue. It
is an American issue. Our healthcare system is broken, and
fixing it is one area where I hope the 80 percent rule comes
into play so that common sense reforms can be made. The
American people deserve solutions.
I also hope we can agree on the process used to advance the
healthcare reform. An open, transparent process with a full
debate is the best way to achieve a bipartisan product.
I was disappointed to see the recent comments of the Senate
majority leader, who suggested that he wanted to use budget
reconciliation to pass healthcare reform. Using budget
shortcuts, known inside the beltway as reconciliation, shuts
out members of the minority party. It will also shut out many
centrist Democrats who want to see healthcare reform based on a
competitive private market which is fully paid for. That is not
a formula for bipartisan success.
At both the member and staff level, Senators on both sides
of the aisle continue to meet regularly to discuss healthcare
reform and, specifically, what shape it will take. I believe
that if we continue to negotiate in good faith, this process
will lead to a bipartisan health reform bill that will enjoy
broad bipartisan support both now and in the future.
I hope that Governor Sebelius will join Senator Baucus,
Senator Conrad, and Senator Byrd in their efforts to prevent
the use of reconciliation from derailing this bipartisan
process. The next Secretary of Health and Human Services will
undoubtedly have a critical seat at the table during these
discussions.
As the Governor of Kansas, the nominee before us has
enormous responsibilities and has put forth her own healthcare
reform proposals there. I know that we have a shared commitment
to reducing the number of uninsured Americans, containing
costs, improving quality, making healthcare more accessible to
everyone, and increasing the access to health information
technology.
During my initial meeting, we discussed the unique
challenges that face rural and frontier States. People living
in rural areas in Kansas, similar to Wyoming, face difficulties
in access to primary care physicians and preventive services.
Rural and frontier areas struggle to attract and retain doctors
and other healthcare providers.
In the 10 steps healthcare reform bill I introduced last
year, I emphasized the importance of access to affordable
healthcare for people in rural and underserved areas. I know
Governor Sebelius understands the challenges in this area, and
I am looking forward to finding solutions for this common
priority.
We may not always agree on every issue. I am and will
remain staunchly pro-life and will continue to advocate for
legislation to protect the rights of the unborn. My hope and
expectation, though, is that we will focus on legislating
solutions that will make a positive difference in people's
lives.
I will have a series of questions for the Governor when we
begin the question and answer portion of the hearing and will
have follow-up questions for the record.
Again, I would like to express my appreciation that the
Senator is back and for having this hearing today.
[The prepared statement of Senator Enzi follows:]
Prepared Statement of Senator Enzi
Mr. Chairman, I would like to begin by thanking you for
holding this hearing today, and welcoming you back to the
Senate. As I have said previously, confirming the President's
nominees is one of the most important Constitutional duties of
the Senate. I know that the members of this Committee take the
"Advise and Consent" clause of the Constitution seriously.
I would also like to thank Governor Sebelius for joining us
today. I am hopeful that we will have a strong working
relationship, as will our staff. If confirmed, there are going
to be areas where we disagree, but my hope and expectation is
that by focusing on solutions, we can produce meaningful
results for hard working Americans that meet the test of the
80-20 rule.
People who have worked with me over time know that the 80-
20 rule is one of the main rules I always try to follow to get
things done. In applying this rule, I try to focus on the 80
percent of the issues the Senate generally agrees, while not
fixating on the remaining 20 percent, which are divisive and
the subject of amendments on the Senate floor. One area where I
hope we can agree on is health care reform. Ensuring access to
affordable, quality and portable health care for every American
is not a Republican or a Democrat issue--it is an American
issue. Our health care system is broken, and fixing it is one
area where I hope the 80-20 rule comes into play so common
sense reforms can be made. The American people deserve
solutions.
I also hope we can agree on the process used to advance
healthcare reform. An open, transparent process with a full
debate is the best way to achieve a bipartisan product. I was
disappointed to see the recent comments of the Senate majority
leader, who suggested that he wanted to use budget
reconciliation to pass health care reform.
Using budget shortcuts--known inside the beltway as
reconciliation--shuts out members of the minority party. It
will also shut out many centrist Democrats, who want to see
health care reform based on a competitive private market, which
is fully paid for. That is a formula for bipartisan success.
At both the member and staff level, Senators on both sides
of the aisle continue to meet regularly to discuss health care
reform, and specifically what shape it will take. I believe
that if we continue to negotiate in good faith, this process
can lead to a bipartisan health reform bill that will enjoy
broad bipartisan support now and in the future. I hope that
Governor Sebelius will join Senators Baucus, Conrad and Byrd in
their efforts to prevent the use of reconciliation from
derailing this bipartisan process.
The next Secretary of HHS will undoubtedly have a critical
seat at the table during these discussions. As the Governor of
Kansas, the nominee before us had enormous responsibilities and
has put forth her own health care reform proposals there. I
know that we have a shared commitment to reducing the number of
uninsured Americans, containing costs, improving quality,
making health care more accessible to everyone and increasing
access to health information technology.
During my initial meeting with Governor Sebelius we
discussed the unique challenges that face rural and frontier
States. People living in rural areas in Kansas, similar to
Wyoming, face difficulties in access to primary care physicians
and preventive services. Rural and frontier areas struggle to
attract and retain doctors and other healthcare providers. In
the 10-steps health care reform bill I introduced last year, I
emphasized the importance of access to affordable health care
for people in rural and underserved areas. Governor Sebelius
understands the challenges in this area--and I am looking
forward to finding solutions for this common priority.
We may not always agree on every issue. I am and will
remain staunchly pro-life, and will continue to advocate for
legislation to protect the rights of the unborn. My hope and
expectation, though, is that we will focus on legislating
solutions that will make a positive difference in people's
lives. The first and foremost priority of our Government should
be, ``do no harm.''
I understand that the Senate Finance Committee, of which I
am a member, has primary jurisdiction over her nomination to
head the Department of Health and Human Services (HHS). But
because of the overlap in our work, the HELP Committee has
established a tradition of holding a hearing on this cabinet
level position.
I will have a series of questions for the Governor when we
begin the Q and A portion of the hearing, and will have follow-
up questions for the record.
In closing, I would like to again thank Chairman Kennedy
for calling this hearing today.
The Chairman. Thank you. Thank you very much.
I want to welcome an old friend, Senator Dole. All of us
are very familiar with his service to the Senate over a long
period of time as our majority leader. I thank him very much.
It is always a welcome opportunity to be with Senator
Roberts. We have worked together on many different issues, and
I have valued the opportunity to see him and welcome him back
now.
We will start off with those two leaders, and then we will
proceed with the remaining members. And after that we will
introduce our nominee.
Senator Roberts. Mr. Chairman, I might inquire if that
means that I am to go first? And as opposed to Senator Dole, I
always live in mortal fear of when I go first, and then Senator
Dole follows me. Is it your preference that I speak now, or
would you prefer to have our colleague go first?
The Chairman. Well, that sounds--I don't see Senator Dole
shaking his head in disapproval. So we will go ahead.
Senator Roberts. Well, I have a lot of nice things to say
about you, Bob. So I thought I would go first, if that is all
right with you?
Senator Dole. I get paid by the hour, so I will just----
[Laughter.]
The Chairman. OK.
Statement of Senator Roberts
Senator Roberts. All right. I will be happy to start off.
Thank you, Mr. Chairman. It is good to have you back.
The Chairman. Thank you.
Senator Roberts. It is good to see you as chairman, sir.
It is a special day and, indeed, for the State of Kansas
because we have with us today the man who is, without question,
the favorite of Kansans and probably the most beloved public
servant in support of our Governor, Kathleen Sebelius.
Senator Bob Dole, honored to have you here. We Kansans are
always mindful of the great legacy that you forged for us in
the Senate. I continually strive to live up to your years of
service to our State.
I would remind everybody that while it is not a topic of
conversation for this hearing, that every time you pass the
World War II memorial or you talk to a World War II veteran who
has experienced a great moving experience in visiting that
memorial, you can thank Bob Dole. That is the kind of man he
is.
And thank you, Bob, for being such a friend of our family
down through the years.
Mr. Chairman, I would like to ask unanimous consent that
the statement by Senator Nancy Kassebaum Baker be included.
Senator Baker said, as a former chairman of this committee,
``It is with the highest regard that I endorse the nomination
of Governor Kathleen Sebelius as Secretary for the Department
of Health and Human Services.''
So I would ask that her statement be included.
The Chairman. It will be included.
Senator Roberts. Well, Governor Sebelius, welcome.
It is a special and great opportunity for a Kansan to be
represented as a member of the President's Cabinet, and I want
to thank President Obama for nominating our Governor for this
very important position.
The Governor and I have had a special relationship. Her
father-in-law, former congressman Keith Sebelius, was my
godfather in this business. I had the privilege of serving as
his administrative assistant during his entire congressional
career. He was a great congressman and mentor and friend.
And I have known Kathleen and her husband, Gary, throughout
the years. Gary is now a judge. We have enjoyed a very special
relationship. I remember well when Gary was a student at Kansas
State University, and I was the administrative assistant to his
father.
And so, we had a quite unique relationship in that respect,
and I would only say that I am sorry that his good friend Rudy
Verdesco could not be here with us today to share during this
time. Obviously, we are not going to get into telling stories.
Governor Sebelius, I look forward to building on that
relationship as we work toward improving our Nation's
healthcare system. I think Senator Enzi pretty well summed it
up in regards to the challenge, as did our chairman, Senator
Kennedy. So I look forward to working with you.
We will have another experience. As a member of the Finance
Committee, I will have another privilege to introduce you at
that particular time.
So thank you very much, Mr. Chairman.
[The prepared statement of Senator Roberts follows:]
Prepared Statement of Senator Roberts
Today is a special day indeed for the State of Kansas. We
have with us today one of Kansas' favorite and most beloved
public servants in support of our Governor, Kathleen Sebelius.
Senator Bob Dole, it is an honor to have you here. Kansans
are always mindful of the great legacy that you forged for us
in the Senate, and I continually strive to live up to your
years of service to our State.
Governor Sebelius, welcome. It is a special and great
opportunity for Kansas to be represented as a member of a
President's cabinet.
Governor Sebelius and I have a special relationship. Her
father-in-law, former Congressman Keith Sebelius, was my
godfather in this business.
I had the privilege of serving as his AA during his
congressional career, and he was a great Congressman and
mentor.
I have known Kathleen and her husband Gary throughout the
years and we have enjoyed a good relationship.
Governor, I look forward to building on that relationship
as we work towards improving our Nation's health care system.
[The prepared statement of Senator Kassebaum Baker
follows:]
Prepared Statement of Nancy Kassebaum Baker
Mr. Chairman and members of the HELP Committee, it is my
honor and pleasure to address this committee on behalf of my
Governor, Kathleen Sebelius. She has represented Kansas with
distinction for 7 years. Prior to that she served as the
Insurance Commissioner of Kansas where she gained national
respect for her knowledge and leadership in the area of health
insurance.
Governor Sebelius grew up in a family prominent in Democrat
politics in Ohio. She married into a family prominent in
Republican politics in Kansas. After converting her husband,
Judge Gary Sebelius, she managed to continue to work across
party lines in the most constructive and substantive ways. This
has not been easy in an independent-minded but strongly
Republican State.
I have worked with Governor Sebelius on several projects
that we both believed important to our State. Her leadership in
bringing to successful fulfillment the Tallgrass Prairie
National Preserve is one example.
Kathleen Sebelius brings to the Department of Health and
Human Services the type of leadership needed at this time. The
important and challenging issues that will be before this
committee and the Department will demand the thoughtful
consideration, good humor and resolve that Governor Sebelius
has always shown in public service.
As a former chairman of this committee, it is with the
highest regard that I endorse the nomination of Governor
Kathleen Sebelius as Secretary for the Department of Health and
Human Services.
The Chairman. Thank you very much.
Now, Senator Dole.
Statement of Robert J. Dole, Former U.S. Senator
from Kansas
Senator Dole. It is an honor to be back in the Senate, and
I am accompanied today by a good friend and a fellow Kansan. I
served with her father, I served with her father-in-law in
Congress, so there has been a long relationship. We call it
bipartisanship in Kansas, and maybe the fact that we start off
by a Republican introducing a Democrat will be a good omen for
what we hope will be a very productive year in healthcare
reform.
My view is that it is time to bite the bullet, and I want
to commend both the chairman and Senator Enzi, but primarily
the chairman. We have been here a long time together. And it
has been high on your priority list for as long as I can
remember, and you got here before I did. I think Strom was
here, too, but not many others.
I went back and checked, and I introduced a bill, along
with Senator Domenici and Senator Danforth, in 1977 that pretty
much picks up a lot of the pieces we are finding in different
bills now. It wasn't all my idea. We had a lot of help from
Democrats and Republicans. In those days, bipartisanship was
pretty well accepted, and normally, we could work out our
differences.
I can't think of a tougher job to step into now than the
Secretary of HHS. I mean, we have a little group of us four
former leaders--Senator Mitchell, Senator Daschle, Senator
Baker, and myself--called the bipartisan panel, and we have
been doing different things in energy. But now we are working
on healthcare, and we hope to unveil our product sometime in
the next couple of months.
We have been working on it over a year, and we understand
just some of the difficulties that Governor Sebelius is going
to have to face up to in the next several months. And Kansas
has tended to be a Republican State for the past 300 or 400
years, and one thing about Kathleen is that she is willing and
able to work with the Republicans and Democrats to try to get
something done. And as I said, I can't think of any more
difficult challenge. It is a critical time.
As Senator Kennedy alluded to, where you are able to have
the best care, you get the best care in America. I have been
blessed with the same opportunities when it comes to good
healthcare over the past 30, 40 years. There are many of us who
understand from personal difficulties, illnesses or whatever,
how important affordable and accessible healthcare is. This
committee is going to be very, very important, along with the
Finance Committee, in making certain that we get something
done.
Now I know the numbers, just look at the numbers. There is
really no need to talk about bipartisanship because the
Democrats have the numbers. I think that misses the point.
This should be bipartisan, nonpartisan, as Senator Mikulski
knows, and we have worked on a lot of issues together, because
the American people understand that when the Ds and Rs are
together--it doesn't have to be some gigantic legislation, but
something that is really important to a segment of the American
people--that it is going to be successful. It is going to be
accepted, and it is going to do a lot of good things for a lot
of good people who now can't afford good quality healthcare. In
many cases, it is not accessible.
I may be wrong, but I think the time has come that we need
to do it and to do it this year. The President has made it a
priority. I know this committee has made it a priority. I know
Senator Baucus and Senator Grassley on the Finance Committee
have made it a priority. And if we will all just give and take
a little, we could end up with some pretty good legislation.
Governor Sebelius's strength is the fact that she
understands healthcare. As the Kansas insurance commissioner,
she has had a lot of experience, and she knows the critical
issues. So she doesn't walk in as somebody who agreed to take
the job. She walks in as someone who is willing and able and
would make the commitment and try to make it work, try to bring
parties together in very critical areas.
We spend a lot of money on healthcare, $2.2 trillion per
year and an estimated 46 million uninsured. I am not certain
who counts 46 million, but that is a lot of people to be
without insurance.
Now some of those could buy insurance. They have the means,
but they don't. Some are younger. A lot of younger people I see
up beyond the dais who think, ``Nothing is ever going to happen
to me. I will buy a new car.'' And so, there are some people
who just don't think they need to buy insurance.
There are millions, millions of people who just can't
afford it, and they have children, and they have grandchildren.
Half of all personal bankruptcies are due to healthcare costs.
People just can't afford to take care of their healthcare bills
and avoid bankruptcy.
So, I would say to this committee and particularly Governor
Sebelius, I think you have the challenge of the year when it
comes to legislative achievement. I am not in Congress anymore,
but I know a few people who are. I know the four of us--Senator
Mitchell, Senator Daschle, Senator Baker and myself--want to be
helpful in any way that we can. If it means disappearing for
several months or whatever you think that will be the most
helpful because we think it is important to pass good, sound
legislation.
I think not acting is not an option anymore. We have been
patching up healthcare, all of us. We have all been a part of
it, and some of it has been very good and very timely, but it
is not a solution. There are always some people left on the
sidelines. There is always somebody rushed to the emergency
room because they didn't have the resources to go anywhere
else.
And so, where do you find this person that is going to be
able to come in and sit down with members and staff and
agencies and work out what I said is the No. 1 topic of the
year? We can't accept the status quo, and it is going to take
members of both parties, not just one or two, but a pretty good
chunk of both parties, even though, as I indicated, Democrats
have plenty of--well, they have got a big bench. They have got
a lot of reserve strength.
It is one of these times, as was the Americans with
Disabilities Act, as the Senator from Massachusetts recalls,
where you just have to say, OK, let us just put partisanship
aside, and we don't care who gets the credit. Let us get it
done. And obviously, the Senator from Massachusetts was a key
player in that debate.
We had people you wouldn't expect from both sides of the
aisle cooperate. In the final analysis, I think we had about
90-some votes. I don't recall. But it shows that things that
people say can't be done can be done.
We have before us a nominee who has the skills, who has the
experience. You know, the family has sort of grown up in
politics. And as I said, I had the honor of serving with your
father, and I think we even voted together on one occasion. But
he was a very fine guy and a man of integrity, as was Senator
Roberts' boss, Congressman Sebelius, who was a great friend,
and that is just the way it works sometimes.
I would just conclude Pat has put in the record the letter
from Senator Kassebaum, and so I don't need to put it in the
record again. But I will just quote just one sentence so she
will know that I did it.
Kathleen and Nancy have been friends for a long time. They
have worked together on healthcare. And they worked together on
the Kennedy-Kassebaum healthcare bill, which is one of the most
recent bills, and what Nancy understands and always understood
is that bipartisanship is a good word and that we shouldn't
hide from it. We ought to develop it and nurture it and let it
grow.
In my time in the Senate, it always occurred to me that if
I could go to Kansas and people knew that not only X number of
Republicans were for it, but also X number, a good number of
Democrats supported the legislation, the constituents would
find it much more acceptable because they knew it was broad
based, and you had to bring different people with different
philosophies and different ideas together.
You never get all you want. I mean, they always talk about
Ronald Reagan as the ideal conservative. But I remember him
telling me when I was the Republican leader, ``If you can get
me 70 percent, take it. I will get the rest next year or maybe
later.'' He never said ``maybe never.'' So Senator Kassebaum,
as the chairman knows, understands the need for working
together.
And finally, as I have said, I have known the family for a
long time, and I know they are, well, men and women of honesty
and integrity and willing to accept this challenge, and I look
forward to working with her. And hopefully, our little
committee with Mitchell and Daschle primarily--and me and
Howard Baker as sort of accomplices, or whatever--we want to
work together.
I know there must be 25 or 30 plans floating around out
there, and so we want to make a pledge to the chairman now. We
have got a lot of resources. We have been working on this for
more than 2 years. It is funded by foundations without an
agenda, without any partisan agenda. And we have a staff that I
think has done a wonderful job, and we will be working with
Governor Sebelius.
So, I guess the question is can we forge a bipartisan
proposal that is accessible, available, and affordable? And I
think we can with steady and strong leadership, and Governor
Sebelius is ready to lead us in that direction.
Thank you.
I would ask that my entire statement be made a part of the
record.
The Chairman. It will be made a part of the record.
[The prepared statement of Former Senator Dole follows:]
Prepared Statement of Senator Bob Dole
Mr. Chairman, Senator Enzi, thank you for that
introduction. Today, it is my honor to accompany to the Senate
a friend and fellow Kansan, Governor Kathleen Sebelius. They
call it bipartisanship.
I'm here at a critical time in the Senate as you take on
the task of reforming a health care system which is on life
supports. Though our country spends $2.2 trillion per year on
health care, an estimated 46 million Americans are uninsured
and millions of these cannot afford adequate coverage.
Statistics show that half of all personal bankruptcies are
caused by health care costs that families cannot anticipate or
afford. Most Americans who have insurance receive the best
medical care available, but the quality of care, for others,
causes the deaths of an estimated 98,000 Americans a year.
The status quo is clearly unacceptable, so not acting is
not an option, and I believe nearly every Member of Congress
agrees. Fixing our health care system will require members of
both parties and the Obama administration to put partisanship
aside. Success will require leadership that ends this crisis
and provides accessible, reasonable and affordable care to all
Americans.
Most importantly at this point in time, we need a Secretary
of HHS who has the skills, experience and courage to shape and
guide legislation through Congress. It will not be easy.
For more than 20 years, Kathleen Sebelius has served the
State of Kansas as a legislator, insurance commissioner and
Governor. All of her accomplishments required bipartisan
approaches.
As insurance commissioner, she rooted out fraud and abuse
and saved Kansas millions of dollars. She fought the sale of
Blue Cross and Blue Shield of Kansas when she believed the sale
would benefit insurance companies and leave patients with
higher bills. As Governor, she protected prescriptions for
seniors in jeopardy of losing their medication. More children
in Kansas have health insurance because of her work to
implement the Children's Health Insurance Program and her work
with Kansas's Health Wave Initiative.
Her work has earned her the respect of Democrats and
Republicans, including our former colleague, Nancy Kassebaum
Baker, who could not be here today but has asked me to have her
letter included in the hearing record at this point. ``Is There
Any Objection?''
I was asked if I could speak in support of Governor
Sebelius' nomination after my friend and colleague, Senator Tom
Daschle, withdrew his name from consideration. President Obama
lost a highly qualified nominee but had another first rate
nominee on hand in Governor Sebelius if she would accept it.
She did, and I'm honored to introduce and endorse her
nomination today. We are from different parties. We have
different views on different issues. Abortion is one of the
most controversial. I'm pro-life. The Governor is pro-choice.
However, President Obama won and now gets to make cabinet
selections. He has determined that Governor Sebelius is well-
qualified, that she understands the importance of the enormous
task she will have when confirmed by the entire Senate. The key
words are that the Governor is ``well-qualified.''
The bottom line is that the position of Secretary of Health
and Human Services has never been more important as it appears
Congress will ``bite the bullet'' and attempt to find a
bipartisan solution to a real problem that affects real people
who cannot afford adequate, accessible and affordable health
care. I've been working with a group called the Bipartisan
Policy Center, along with former leaders Howard Baker, Tom
Daschle, and George Mitchell, to come up with what we hope are
meaningful, bipartisan suggestions. We've been working for more
than a year, and I know firsthand how hard it is to get
agreements.
I know the Sebelius family very well--Keith and Betty (both
deceased), their son Gary, and grandsons Ned and John. I served
in Congress with both Keith and Kathleen's father, John
Gilligan. Both were highly regarded men of integrity.
Governor Sebelius will work with members on both sides as
the country struggles to find an answer to the most important
domestic issue of our day: Can we forge a bipartisan proposal
that is accessible, available, and affordable? We can with
steady and strong leadership and Governor Sebelius is ready to
lead us in the right direction. Thank you.
The Chairman. Thank you, Senator Dole.
You brought back a lot of memories in the legislation, the
ADA program, and our other legislation that was so important in
the past. You ran us through the history of healthcare. It is
good to listen to your comments and hear again the history of
so much of healthcare that you were a part of and that
continues to be a part of our whole legacy here on healthcare.
We always value it and we are always impressed by your
knowledge about this legislation. Your strong commitment on
healthcare will be enormously valuable to all of us as we are
working on this issue on our committee, other committees, and
the Finance Committee. We are working closely with them.
We value your knowledge and understanding and
participation. It is an enormously valuable and useful effort
for all of us, and we are very, very glad to have your presence
here and to listen to your comments.
I will excuse Senator Dole, if he feels that he has to
leave.
Senator Dole. Is it OK if I stay a while?
The Chairman. Stay a while. We are more than delighted to
have him here.
Senator Brown. Mr. Chairman.
The Chairman. Yes.
Statement of Senator Brown
Senator Brown. Mr. Chairman, I apologize for arriving late.
I was at a banking markup, and I just wanted to take just 30
seconds to welcome Governor Sebelius. Senator Dole, it is good
to see you. Thank you for your comments.
Governor Sebelius comes from a long line of public servants
in my home State. Her father, as we know, was Governor some 30
years ago, and she was so active always in Ohio in so many
good, public-spirited ways, as her family continues to be.
Her dad, after leaving the Governor's office and going to
Notre Dame, came back and, at the age of about 80, was elected
to the school board, served two terms in Cincinnati dealing
with so many of those problems that big city public school
systems have.
She has been a terrific Governor, and I look forward to
working with her as Secretary of Health and Human Services.
Thank you, Mr. Chairman, for that.
The Chairman. Thank you very much.
Governor, we are delighted to have you here. You have had a
long career, a distinguished career in a number of different
areas of public policy and have been especially focused on the
issues of healthcare. And obviously, it is an area where all of
us on this committee are deeply interested.
So it is a very distinguished background and experience,
and it really is a special honor to have a chance to introduce
you here at this time before our committee. And I would ask you
to proceed, if you would?
STATEMENT OF KATHLEEN SEBELIUS, GOVERNOR,
STATE OF KANSAS, TOPEKA, KS
Governor Sebelius. Well, thank you very much.
Chairman Kennedy, Senator Enzi, members of the committee, I
want to thank you for inviting me here today to discuss my
nomination as Secretary of Health and Human Services.
I want to start by recognizing two people who are not with
me today. As has already been mentioned, Senator Kassebaum, the
former chair of this committee, was hoping to come. She wanted
to say hello to old colleagues and be here today.
She was one of the 20,000 Kansans who lost power over the
weekend with our ice storm. So that kind of rearranged her
plans. I am hopeful that she is able to participate in this
hearing at least by television, which will mean her power is
back on at home.
The other person I want to particularly mention is my
husband, Gary Sebelius, who, 34 years ago, brought me from
Washington to Kansas. He was the Kansan. He is a Federal
magistrate judge, and his overly packed criminal docket on
Tuesdays prevented him from rearranging that schedule. But they
are here in spirit.
I am honored to have the two Kansans who have already
spoken here with me because not only have they been colleagues
in the workplace, but they are good friends of the family. And
as Senator Sherrod Brown has already said, he has been a
longtime friend of the Gilligan family. So I feel well
represented by family friends here today.
I am so honored that President Obama has asked me to fill
this critical role at such an important time. The Department of
Health and Human Services strives for a simple goal--protecting
our Nation's health and providing essential human services.
Among its many initiatives, the department supports
genomics research to find cures for debilitating diseases that
afflict millions of Americans and challenge their families;
provides children the healthcare, early education, and
childcare they need to enter school ready to learn; and
protects the health and well-being of seniors through Medicare.
The department is also charged with sustaining our public
health system and promoting safe food, clean water and
sanitation, and healthy lifestyles.
Working in concert with scientific advances and medical
breakthroughs and an ever-evolving understanding of the human
condition, the department's efforts have made a difference over
time. Yet at the beginning of the 21st century, we find new and
daunting challenges. Perhaps most importantly, as members have
already reflected, we face a healthcare system that burdens
families, businesses, and government budgets with skyrocketing
costs. Action is not a choice. It is a necessity.
I am excited to join the President in taking on these
challenges, should I be confirmed. Many are the same challenges
I have addressed as Governor, as insurance commissioner, and as
a State legislator.
I am proud to have worked for more than 20 years to improve
Kansas's access to affordable quality healthcare, to expand
access to high-quality childcare and early childhood education,
to assist our seniors with Medicaid challenges and Medicare
billings, to work to expand the pipeline of healthcare
providers, and to ensure access to vital health services in our
most rural areas.
I have also been a healthcare purchaser, directing the
State employee healthcare benefits program, as well as
overseeing operation of health services in our correctional
institutions, Medicaid and CHIP programs, and coordinating with
local and community partners on health agencies across Kansas.
As insurance commissioner, I took the then unprecedented
step of blocking the sale of Blue Cross Blue Shield of Kansas
to a healthcare holding company, Anthem of Indiana, because all
the evidence before me suggested that premiums for Kansans
insured by Blue Cross would have increased too much.
These efforts have yielded results. Our uninsured rate in
Kansas is lower than the national average. Our health
statistics are improved, and Kansas has been ranked first for
healthcare affordability for employers and received a five-star
rating for holding down health costs.
I hope you give me the opportunity to apply my experience
as Governor and insurance commissioner to the challenges of
advancing the health of the Nation. These challenges are
significant. Healthcare costs are crushing families,
businesses, and government budgets. Since 2000, health
insurance premiums have almost doubled, and an additional 9
million Americans have become uninsured.
We have, by far, the most expensive health system in the
world. We spend 50 percent more per person than the next most
costly Nation. Americans spend more on healthcare than on
housing or food. General Motors spends more on healthcare than
they do on steel.
High and rising health costs have certainly contributed to
the current economic crisis and represent the greatest threat
to our long-term economic stability. Rapid projected growth in
Medicare and Medicaid accounts for most of the long-term
Federal fiscal deficit. And at the State and local levels,
policymakers are forced to choose between healthcare and other
priorities like public education and public safety.
American jobs are also at stake. Businesses are striving to
maintain both coverage and competitiveness, and currently there
is no relief in sight. That is why I share the President's
conviction that, as he says, healthcare reform cannot wait. It
must not wait. It will not wait another year. Inaction is not
an option. The status quo is unacceptable and unsustainable.
Within days of taking office, the President signed into law
the reauthorization of the Children's Health Insurance Program,
a hallmark of the bipartisanship and public-private
partnerships we envision for health reform. Implementing this
program in partnership with the States will be one of my
highest priorities.
President Obama has also worked to enact and implement the
American Recovery and Reinvestment Act. This legislation
includes essential policies to prevent a surge in the number of
uninsured Americans and makes positive investments now that
will yield health and economic dividends later.
Through health information technology, the Recovery Act
lays the foundation for a 21st century system to reduce medical
errors, lower healthcare costs, and empower health consumers.
It supports vital information gathering by investing over a
billion dollars in comparative effectiveness research, to
provide information on the relative strengths and weaknesses of
alternative medical interventions to health providers and
consumers. The Recovery Act also makes an historic investment
in prevention.
The President's budget, submitted in February, continues
the work begun in the Recovery Act. It dedicates $634 billion
over the next decade to reforming the healthcare system. Its
proposals would align payment incentives with quality, promote
accountability and efficiency, and encourage shared
responsibility. Still, the President recognizes that the
reserve fund is not sufficient to fully fund comprehensive
reform and is committed to working with Congress to find
additional resources to devote to healthcare reform.
We appreciate the tremendous leadership of this committee
to work to solve the great challenge for our Nation and hope to
see action in the coming months. Should I be confirmed, health
reform will be my mission, as it is the President's, along with
the tremendous responsibility of running this critical
department. So I would like to highlight a few opportunities
and challenges facing the department.
The Centers for Disease Control and Prevention, CDC, is
critical to forging a 21st century health system that
prioritizes prevention. Its mission is to create the expertise,
information, and tools that people and communities need to
protect their health. If confirmed, I will continue the proven
strategies for success, as well as revitalize the CDC for its
heightened role in a reformed health system.
As Americans focus more on prevention and leading healthier
lifestyles, HHS must live up to its responsibility to protect
the public from health risks. It is a core responsibility of
the agency, through the FDA, to ensure that the food we eat and
the medications we take are safe.
Unfortunately, there is a growing concern that the FDA may
no longer have the confidence of the public and of Congress. If
confirmed as Secretary, I will work to restore in the FDA the
trust of the American people and restore the agency as the
leading science-based regulatory agency in the world.
As important as it is to protect people by regulating
drugs, it is equally important that we discover new drugs and
treatments that can prevent, treat, and cure disease. The
National Institutes of Health provide that critical support.
The mission of NIH is science in pursuit of knowledge about the
nature and behavior of living systems and the application of
that knowledge to extend healthy life, combat illness, and ease
the burden of disability.
If confirmed, I will work to strengthen NIH with leadership
that focuses on the dual objectives of addressing the
healthcare challenges of our people and maintaining America's
economic edge through innovation.
Leading the Department of Health and Human Services and
working with the President to reform the health system won't be
easy. If it were, as the President has noted, our problems
would have been solved a century ago.
The status quo cannot be sustained and is unacceptable for
our economic prosperity and for the health and wellness of the
American people. Previous opponents of health reform are now
demanding it, putting the common interests in an affordable
quality system of care for all, ahead of special interests, and
policymakers, like those of you in this room and men and women
who serve in Congress are reaching across party and ideological
lines to accomplish this urgent task.
I hope I have the opportunity to join you, and I look
forward to your questions.
[The prepared statement of Governor Sebelius follows:]
Prepared Statement of Kathleen Sebelius
Chairman Kennedy, Senator Enzi, members of the committee, thank you
for inviting me here today to discuss my nomination to be the Secretary
of Health and Human Services.
I am honored that President Obama has asked me to fill this
critical role at such an important time.
The Department of Health and Human Services strives for a simple
goal: protecting our Nation's health and providing essential human
services. Among its many initiatives, the Department supports genomics
research to find cures for debilitating diseases that afflict millions
of Americans and challenge their families; provides children the health
care, early education, and child care they need to enter school ready
to learn; and protects the health and well-being of seniors through
Medicare. The Department is also charged with sustaining our public
health system and promoting safe food, clean water and sanitation, and
healthy lifestyles.
Working in concert with scientific advances, medical breakthroughs,
and an ever-evolving understanding of the human condition, the
Department's efforts have made a difference. People born in 2000 can
expect to live nearly three decades longer than those born in 1900.
Since 1900, infant mortality has dropped by 95 percent and maternal
mortality by 99 percent. Diseases like polio have been eradicated.
Yet, at the beginning of the 21st century, we face new and equally
daunting challenges. We face an obesity epidemic that threatens to make
our children the first generation of American children to face life
expectancies shorter than our own. Globalization has made a flu strain
in a remote country a potential threat to America's largest cities. We
now must guard against manmade as well as natural disasters, as disease
has become a weapon. Perhaps most importantly, we face a health system
that burdens families, businesses, and government budgets with sky-
rocketing costs. Action is not a choice. It is a necessity.
WORK ON IMPROVING THE HEALTH OF KANSANS
I'm excited to join the President in taking on these challenges.
Many are the same challenges I've addressed as Governor, as Insurance
Commissioner, and as a State Legislator. I'm proud to have worked for
more than 20 years to improve Kansans' access to affordable, quality
health care; to expand access to high-quality child care and early
childhood education; to assist seniors with Medicare challenges; to
work to expand the pipeline of health care providers; and to ensure
access to vital health services in our most rural areas. In Kansas,
affordable health care for children, seniors, and small businesses has
been a special priority for me.
I was asked by my predecessor, Republican Governor Bill Graves, to
lead the team to design and implement the Children's Health Insurance
Program. Our separate insurance initiative called Health Wave is
modeled on the State employee program. Its enrollment started at 15,000
in the first year; today, it covers over 51,000 children. And the
Legislature just voted to support my recommendation that our CHIP
program be expanded.
I have also worked to make life-saving medications affordable. I
established counseling programs to help seniors navigate the
complicated Medicare prescription drug benefit plan. When seniors
started falling through the cracks of the new drug program, I directed
the State to pay their prescription costs to Kansas pharmacies to
prevent the loss of coverage. During this period, we filled 45,000
prescriptions for Medicare-eligible seniors.
These efforts have yielded results. The uninsured rate in Kansas is
lower than the national average. Our health statistics are improved.
And Kansas has been ranked first for health care affordability for
employers and received a five-star rating for holding down health care
costs.
I have also been a health care purchaser, directing the State
employee health benefits program as well as overseeing the operation of
health services in our correctional institutions and Medicaid and CHIP
programs, and coordinating with local partners on health agencies
across Kansas. I took these jobs seriously. In November 2005, we
successfully negotiated a new health insurance contract to reduce
premium costs with no loss of benefits for thousands of State
employees. At a time when health costs were skyrocketing, I worked with
the Legislature to streamline the health care bureaucracy, and leverage
our purchasing power within State government. I signed legislation to
create a new independent State agency, the Kansas Health Policy
Authority, to manage nearly all of the State's spending on health care,
simplify the process of obtaining health care, and use the State's
buying power to reduce costs. We have launched focused prevention and
wellness efforts, in collaboration with schools, communities,
employers, and senior centers. Our health IT work has been nationally
recognized, and we are the first State in the country to use a ``smart
card'' for our Medicaid population. As Insurance Commissioner, I
created a Fraud Squad that worked with the Attorney General's Office to
aggressively pursue fraud and abuse, and recovered millions of dollars
during my tenure.
In these roles, I know first-hand the challenge of standing up to
the special interests to protect consumer interests. As Insurance
Commissioner, I made a patient-protection bill the centerpiece of a
2000 legislative proposal. In 2002, I took the then-unprecedented step
of blocking the sale of Blue Cross and Blue Shield of Kansas to the
health care holding company of Anthem of Indiana. I did so because all
evidence suggested that premiums for Kansans insured by Blue Cross
would have increased too much, and providers would have been adversely
impacted. I was the first State Insurance Commissioner to block such a
deal, although others have followed.
HEALTH REFORM
I hope you give me the opportunity to apply my experience as a
Governor and Insurance Commissioner to the challenges of advancing the
health of the Nation. These challenges are significant.
Health care costs are crushing families, businesses, and government
budgets. Since 2000, health insurance premiums have almost doubled and
an additional 9 million Americans have become uninsured. Since 2004,
the number of ``under-
insured'' families--those who pay for coverage but are unprotected
against high costs--rose by 60 percent. Just last month, a survey found
over half of all Americans (53 percent), insured and uninsured, cut
back on health care in the last year due to cost.
The statistics are compelling, as are the stories. During the
transition, the President encouraged Americans to share their personal
experiences and stories through Health Care Community Discussions. Over
30,000 people engaged in these discussions. In Manhattan, KS, a parent
told the story of a 27-year-old son who was working at a convenience
store. Although he was offered insurance, he thought it was too
expensive. A bicycle accident sent him to the emergency room and
generated a hospital bill of more than $10,000, which he and his
parents are struggling to pay off.
In Pittsburg, KS, a health care provider shared that during the
last 3 years, three women in similar situations had been identified
with breast cancer. One woman received care, as she had insurance, and
had a good health outcome. Two women had to wait for a pre-existing
condition time delay on their health insurance to lapse; both ended up
with their cancers advancing, and neither received care.
Heartbreakingly, both women died within the year.
And, in Houston, TX, the challenges health costs pose to businesses
were discussed. One participant asked, ``How can you go out on a limb
and start a new business when health care is a noose around your neck?
''
We have by far the most expensive health system in the world. We
spend 50 percent more per person than the next most costly nation.
Americans spend more on health care than housing or food. General
Motors spends more on health care than steel.
This cost crisis in health care is worsening. The United States
spent about $2.2 trillion on health care in 2007; $1 trillion more than
what was spent in 1997, and half as much as is projected for 2018.
High and rising health costs have certainly contributed to the
current economic crisis. A recent study found nearly half of Americans
with homes in foreclosure named medical problems as a cause. Rising
health costs also represent the greatest threat to our long-term
economic stability. If rapid health cost growth persists, the
Congressional Budget Office estimates that by 2025, 25 percent of our
economic output will be tied up in the health system, limiting other
investments and priorities.
This is paralleled in Federal and State budgets. Rapid projected
growth in Medicare and Medicaid accounts for most of the long-term
Federal fiscal deficit. And, at the State and local levels,
policymakers are increasingly put between the ``rock'' of health care
costs and the ``hard place'' of other priorities, like public education
and public safety.
American jobs are also at stake. ``Old-line'' industries are
striving to maintain both coverage and competitiveness--locally and
globally. New industries and businesses are struggling to offer
coverage in the first place. Both workers and their employers are
concerned about the future of employer-sponsored health insurance.
Currently, there's no relief in sight.
This is why I share the President's conviction that ``health care
reform cannot wait, it must not wait, and it will not wait another
year.'' Inaction is not an option. The status quo is unacceptable, and
unsustainable.
Within days of taking office, the President signed into law the
reauthorization of the Children's Health Insurance Program. This
program's success in covering millions of uninsured children is a
hallmark of the bipartisanship and public-private partnerships we
envision for health reform. Implementing this program in partnership
with the States will be one of my highest priorities.
President Obama has also worked to enact and implement the American
Recovery and Reinvestment Act in partnership with governors, mayors,
Congress, and private partners. This legislation includes essential
policies to prevent a surge in the number of uninsured Americans. It
also will help an estimated 7 million people affected by unemployment
keep their health insurance through COBRA (i.e., continuation coverage
for certain workers leaving their jobs). There is essential additional
aid to States providing health benefits, making sure that people with
disabilities and low-income Americans who rely on Medicaid benefits
don't lose coverage as States try to balance their budgets. The
Recovery Act prevents an already-bleak health-
coverage situation from getting worse.
The Recovery Act also makes positive investments now that will
yield health and economic dividends later. Through health information
technology, it lays the foundation for a 21st-century system to reduce
medical errors, lower health care costs, and empower health consumers.
In the next 5 years, HHS will set the standards for privacy and
interoperability, test models and certify the technology, and offer
incentives for hospitals and doctors to adopt it. The goal is to
provide every American with a safe, secure electronic health record by
2014.
The Recovery Act supports vital information gathering as well as
information technology. It invests $1.1 billion in comparative
effectiveness research to provide information on the relative strengths
and weaknesses of alternative medical interventions to health providers
and consumers.
The Recovery Act also makes an historic investment in prevention.
We cannot achieve our ultimate goal--a healthier nation--unless we
shift away from a sick-care system. We pay for emergencies, not the
care that prevents them, with little emphasis on the responsibility
each of us has in keeping ourselves and our families well. The $1
billion for prevention in the Recovery Act will empower every American
through immunizations, chronic disease prevention, and education.
The President's budget submitted in February continues the work
begun in the Recovery Act. It dedicates $634 billion over 10 years to
reforming the health care system. Its specific proposals would align
payment incentives with quality, promote accountability and efficiency,
and encourage shared responsibility. The President recognizes that
while a major commitment, the reserve fund is not sufficient to fully
fund comprehensive reform. He is committed to working with Congress to
find additional resources to devote to health care reform.
The President is also committed to hearing from Americans across
the Nation. In March, he held a White House health care forum and
several regional forums in places like Iowa, Vermont, and North
Carolina. There, bipartisan forums brought together people from all
perspectives--across the political spectrum and representing all people
with a stake in the system--to focus on solutions.
We appreciate the tremendous leadership of this committee to
address this urgent challenge. The leadership in Congress is getting to
work to solve this great challenge for our Nation, and we hope to see
action in the coming months.
Should I be confirmed, health reform would be my mission--as it is
the President's--along with the tremendous responsibility of running
this critical Department. And so, I would like to highlight a few of
the opportunities and challenges currently facing the Department.
CENTERS FOR DISEASE CONTROL AND PREVENTION
The Centers for Disease Control and Prevention (CDC) is critical to
forging a 21st-century health system that prioritizes prevention. Its
mission is to create the expertise, information, and tools that people
and communities need to protect their health. For example, thanks in
part to CDC immunization programs, most childhood vaccine-preventable
diseases have been reduced by 95 percent from pre-vaccine levels. For
each birth cohort vaccinated, society saves $33.4 billion in indirect
costs; direct health care costs are reduced by $9.9 billion;
approximately 33,000 lives are saved; and 14 million cases of disease
are prevented. In addition, today, heart disease rates have declined by
half, in no small measure because of the role of community-based
prevention.
If confirmed, I will continue proven strategies for success as well
as revitalize CDC for its heightened role in a reformed health system.
I will work to strengthen its ability to detect and investigate health
problems, conduct research to enhance prevention, develop and advocate
sound public health policies, implement prevention strategies, promote
health behaviors, and foster safe and healthful environments. CDC could
also focus on ensuring effective coordination between public and
private resources at the national, State, and community levels to
promote wellness throughout the lifespan, and ensure healthy
communities. Through executive actions, partnership, and health reform,
CDC can play a vital role in reducing the impact of childhood diseases,
chronic diseases, and diseases that target the aging population.
Moreover, CDC will play a crucial role in health reform since strong
and effective disease prevention and health promotion go hand in hand
with the President's goal of providing affordable, quality health
coverage to all Americans.
FOOD AND DRUG ADMINISTRATION
As Americans focus more on prevention and leading healthier
lifestyles, HHS must live up to its responsibility to protect the
public from health risks. It is a core responsibility of HHS, through
the FDA, to ensure the food we eat and the medications we take are
safe. The FDA is responsible for the safety of thousands of items
Americans depend upon every day, from toothpaste to fruits and
vegetables to the extraordinary drugs, vaccines, and medical devices
that save our lives. The agency regulates goods that account for 25
percent of all consumer spending--more than $1 trillion. Unfortunately,
there is growing concern that the FDA may no longer have the confidence
of the public and Congress. Nearly two-thirds of Americans do not trust
the FDA's ability to ensure the safety and effectiveness of
pharmaceuticals.
If confirmed as Secretary, I will work to restore trust in the FDA
as the leading science-based regulatory agency in the world. I will do
so by working to strengthen the FDA's ability to meet the pressing
scientific and global challenges of the 21st century, and by sending a
clear message from the top that the President and I expect key
decisions at the FDA to be made on the basis of science--period.
NATIONAL INSTITUTES OF HEALTH
As important as it is to protect people by regulating drugs, it is
equally important that we support efforts to discover new drugs and
treatments that can prevent, treat, and cure disease. The National
Institutes of Health (NIH) provides that critical support, and has
funded a range of discoveries that have enabled us to live longer and
more healthful lives. In many areas--for example, what we are learning
from the human genome project--we are on the verge of even more
exciting and promising scientific discoveries.
The mission of NIH is science in pursuit of knowledge about the
nature and behavior of living systems, and the application of that
knowledge to extend healthy life, combat illness, and ease the burden
of disability. It is well documented that investment at NIH reaps
significant rewards, not only for the health of our citizens, but for
the strength of our economy. Yet funding in the previous administration
slowed considerably. We have seen a sharp fall in the success rates for
grant applicants, now as low as 10 percent for many NIH Institutes.
This has come at a time when the economic downturn has hurt the ability
of businesses, universities, and charities to serve as alternative
sources of research support. NIH has also suffered from some instances
of people putting politics before science.
If confirmed, I will work to strengthen NIH, with leadership that
focuses on the dual objectives of addressing the health care challenges
of our people and maintaining America's economic edge through
innovation. We will ensure that the agency has the support to capture
the opportunities of biomedical research that are core Department's
mission of improving the quality and length of our lives.
CONCLUSION
Leading the Department of Health and Human Services and working
with the President to reform the health system won't be easy. If it
were, as the President has noted, our problems would have been solved a
century ago. But the status quo cannot be sustained, and is
unacceptable both for our economic prosperity and the health and
wellness of the American people. Previous opponents of health care
reform are now demanding it, putting the common interest in an
affordable, quality system of care for all ahead of special interests.
And policymakers like you are reaching across party and ideological
lines to accomplish this urgent task. I hope I have the opportunity to
join you, and I look forward to your questions.
The Chairman. Thank you very much, Governor.
Here is the million-dollar question on the minds of all
Americans. It is a simple one. How in the world are you going
to get healthcare reform? We will just move on from there.
[Laughter.]
Give you another opportunity later on in the----
Governor Sebelius. My answers are limited to an hour and a
half.
The Chairman. OK. There we go. Just seriously, you have
been on the front lines of healthcare. What have you learned
from those experiences that will help us enact healthcare
reform?
Governor Sebelius. Well, Mr. Chairman, in my service as
Governor and as insurance commissioner, I have learned some
valuable lessons. I would say the first of which States can't
do it alone. A lot of States have been struggling over the last
decade or more to expand health coverage to our citizens, but
it is a daunting task without a Federal policy in place and a
Federal partner.
I am very pleased that we have an administration committed
to tackling this key problem and a lot of enthusiasm, both
among Republicans and Democrats, that we need to reform the
healthcare system. No question that costs are crushing, and
addressing the cost system means overhauling the way we focus
our healthcare system.
Certainly the efforts that this Congress has already made
in investing in prevention is a huge step forward. I am a
believer, along with a lot of the members of this body, that
prevention services, intervention at an earlier stage in
illness is one of the ways to reduce costs.
Insuring every American helps us recapture the overpayment
of Americans who are now accessing the health system through
the doors of an emergency room, where they get the most
expensive, least effective kind of care. We see it over and
over again in Kansas. We see it in every town in America, and
that is primarily caused by a failure to have a health home and
a primary provider.
Certainly reorganizing the incentives for primary care and
earlier intervention and tackling the problems of chronic
disease.
The assets of the agency, which I have been asked to lead
and which I hope I have an opportunity to do, if confirmed, can
be enormously powerful in building the blocks of the health
reform puzzle--making sure that the Medicaid and Medicare
program work efficiently and effectively; making sure that we
adequately roll out the expanded application of CHIP, the
program for children's health insurance, which has been
probably one of the most significant enhancements to health
insurance in the last several decades; and making sure that our
research and scientific capabilities are directed to the best
possible care at the best possible price.
I am enthusiastic that the lessons learned as Governor and
insurance commissioner can now be taken to the national level.
The Chairman. Let me ask you, should we wait? There are
many who think that we should wait on healthcare and healthcare
reform, try and get the costs down at different parts, perhaps
have a gradual movement toward healthcare reform. But what is
your sense about whether we should or shouldn't wait to see
this reform taking place, given our current economic crisis?
Governor Sebelius. Well, Senator, I think our current
economic crisis presents the inevitability that we cannot wait.
I believe, as the President has articulated over and over
again, that we can't fix the economy of America without fixing
the healthcare system. It is so intricately tied to the costs
that employers are now spending and finding themselves less
competitive with global partners. It is incredibly tied to the
burden that American families face with bankruptcy and health
costs.
So, I think the urgency is upon us, and I think the lessons
from Massachusetts, your home State, a State which has an
impressive attempt to expand coverage to all in Massachusetts,
gives us some important rules to keep in mind. The folks in
Massachusetts would tell you that they decided to work in
incremental steps, to first tackle the opportunity to expand
healthcare to all citizens and second to tackle the cost
situation.
Unfortunately, they are in a situation right now where
coverage has been expanded, and that is very good news. But
costs continue to rise. So I think the lesson learned is that
not only must we approach health reform, but it needs to be a
comprehensive effort. That unless we face the costs at the same
time we are expanding coverage, we really haven't made as much
progress as we can, and we won't have provided the pathway to
prosperity for American workers, for American businesses, and
American families.
The Chairman. All right.
We are going to try to get a 5-minute rule on this. But to
do that, we are going to have to ask all of our colleagues to
be as brief as they possibly can in order to try and get
through as many questions as we can. We thank all of our
colleagues for respecting that.
Senator Enzi.
Senator Enzi. Thank you, Mr. Chairman.
As I mentioned when we met, this committee does pass a lot
of legislation, and one of the reasons it does that is because
we work together. One example of that is the National Service
Act that was just passed last week.
Senator Mikulski did a marvelous job of pulling everybody
together, holding the hearings in Senator Kennedy's absence.
Senator Hatch did a great job of working from the other side.
And Senator Coburn did a marvelous job of introducing matrices,
and Senator Mikulski listened to that. So there was an
improvement in the bill through that part of the process.
But a good working relationship requires both the majority
and the minority to listen and work with each other. And in
light of that, the first question I always ask is, if
confirmed, will you pledge to cooperate in this type of a
working relationship with the Senators of the committee, both
Democrats and Republicans, by promptly responding to any
written or phone inquiries, sharing information as soon as it
becomes available, and directing your staff to do the same?
Governor Sebelius. Senator, you have my commitment, if
confirmed, that I will be not only an eager partner to work
with Congress, but that I understand bipartisanship, as
Senators Dole and Roberts have already indicated. I am a
Democrat in a State where the majority of voters are
Republicans. The vast majority of our legislature are
Republicans. And yet, time and time again, I have found ways to
work across party lines and get things done.
I think that is what the American people expect of me as
Secretary. If I am confirmed, I pledge to work in that same
fashion that I bring out of Kansas.
Senator Enzi. Thank you.
I know that you are a former legislator. So I know that you
have a full appreciation for how debate and respect for the
process does lead to bipartisan legislation.
In the interest of the bipartisan support for health
reform, I hope that you will join Senator Baucus and Senator
Conrad, the chairman of the Budget Committee, to discourage
members from using the budget reconciliation process to pass
healthcare reform so that there is the appearance and the
reality of an open process. Would you do that?
Governor Sebelius. Well, Senator, I know that the President
is very dedicated to having a bipartisan process for health
reform. He talked extensively during the course of the campaign
about the need to reform the health system but chose a
different pathway than the previous experience, which was
really to lay out some principles but make it very clear that
he believes strongly that this cannot be a success unless
Congress is engaged and involved in the process.
I think you saw his efforts shortly after the campaign to
reach out to Americans in community conversations across the
country. The recent health summit, where members of the House
and Senate, Republicans and Democrats, as well as stakeholders
from across the spectrum were invited to the White House, those
summits have been continued in regional meetings chaired by
Governors across the country. One, in fact, is taking place
today in North Carolina, Senator Burr's home State.
I think there is an absolute dedication to engaging
Republicans and Democrats in this effort. I would say I think
there is also an urgency about this effort this year to get
something passed, and at least in the preliminary discussions
that I have had with members of Congress, there is an interest
in not taking any tools off the table prematurely, but being
very dedicated to a bipartisan process and a bipartisan bill.
Senator Enzi. I am afraid that if that reconciliation winds
up in the budget bill, it will be like a declaration of war or,
hopefully, not quite that drastic. But even you mentioned West
Virginia, Senator Byrd has even done an example of why that
should not be the process. I think we have set up a schedule as
this board of directors to meeting a tight timetable for
getting something done.
And this time with having Congress involved in the process,
I am confident that something will happen with it and in a
relatively short period of time. But I hope that that wedge
doesn't get thrown in there because it is a major concern on
one side of the aisle.
I will move quickly to health IT. I had discussions with
the Mayo Clinic and with some other clinics and then the CEO of
Safeway, who has talked about the need to be able to aggregate
information in health IT. And I think that some of the
legislation that we have done already the privacy is so strong
that I am not sure the individual can look at the record, let
alone the doctor look at the record. And it definitely cannot
aggregate so that you can figure out problems to solve in a
major way.
Since my time has expired, I will submit that to you in
writing, along with a number of other questions that I have
here. So I reserve the time.
The Chairman. Thank you very much.
Senator Mikulski, very delighted to have you.
Statement of Senator Mikulski
Senator Mikulski. Thank you, Senator Kennedy. It is so
great to see you back in the chair. I mean, we are really
genuinely and enthusiastically happy to see you.
Governor Sebelius, we are happy to welcome you and see
Senator Dole.
Just very quickly, the women of Kansas have a terrific
reputation. When I first came to the Senate, there were only
two women. Now there are 17. But the other woman was my very
good friend, Senator Nancy Kassebaum Baker.
It is a treasured relationship, and I see common
characteristics in you both. No. 1, a style of civility, which
I think will go a long way; No. 2, competent and yet unfailing
common sense, finding that sensible center; and then also
compassion, but a desire to find, again, those pragmatic
solutions. So we are happy to see another woman from Kansas.
Governor Sebelius. I thought you were going to start with
my gray hair and Nancy's gray hair.
Senator Mikulski. No, no, no. No other woman would ever go
in that direction.
[Laughter.]
We both value the miracles of modern chemistry.
[Laughter.]
But let me go on, though, to how I see you. I see you as
the CEO of HHS, bringing your very extensive executive
experience and executive ability to the job of managing 67,000
employees.
Let me go right to health reform and something that is the
baseline in it, which is health IT. Whatever we want to do in
health reform, health IT will help with both case management,
reducing medical errors, all these good things. However, there
is a great fear over interoperability. It is one I share. It is
one providers, hospitals, and all share.
How will you stand sentry over this process to avoid what
we fear is a ``techno Katrina? '' We are all saying that--even
the President said this is low-hanging fruit. Oh, we can do it.
But what we are concerned about is the failure of
interoperability, the failure of compatibility. The failure to
have clear national standards quickly could result in a fiscal
and case management boondoggle.
So we want a boon and not a doggle. Tell me how you are
going to do it.
Governor Sebelius. Well, Senator, I think you have
identified one of the linchpins of the health reform effort
that has to be underway, and I am so appreciative that
Congress, in the passing of the Recovery Act, identified that
expenditures for health IT was a fundamental building block for
a new system of healthcare.
As you have just said, it doesn't matter if we just take
all the paper and translate it to computers and have systems
that still don't speak to one another, providers who have to
replicate their forms and billing opportunities 10 and 15 and
20 times, hospitals that can't track a patient----
Senator Mikulski. Governor, you are identifying the
problem. But how are you going to make sure we get to the
solution?
Governor Sebelius. Well, the department has just identified
a new leader for the health IT system in David Blumenthal, who
is nationally renowned and has the expertise, I think, to be
the point person for this very important effort. And the
challenge is, as you said, to have standards that work.
There is a broad-based stakeholder group at the table. They
have a very aggressive timetable to develop interoperable
standards and address the initiative to begin then to have
investments available for clinics and doctors and hospitals to
put the system in place. But step one is to get a platform
where people talk to each other.
As Governor of Kansas, we have worked on a health IT system
for the last 3 years. I think we actually are ahead of a lot of
the country, where we put insurers, providers, the major
hospital groups, and others at the table because we knew that
investments were not worthwhile unless there was a common
platform.
We are going to be the first State in the country that has
implemented a smartcard for Medicaid patients, where they will
be able to swipe a card in services and benefits. We have a
single billing system that will be in place by the end of this
year. So providers will fill out one form, and any insurance
company who wants to do business in our public system in Kansas
will have to abide by that one billing form.
I have some experience as insurance commissioner and as
Governor in working on this platform, and I think we have the
right leader in place to move this initiative forward.
Senator Mikulski. Well, here is where I am. First of all, I
am an enthusiastic supporter of your nomination. I think you do
bring the right stuff to the job, and I think that right stuff
is exactly your personality characteristics, your know-how, and
your executive ability.
On this health IT, whether it is prevention, controlling
costs, etc, I am sure Dr. Blumenthal will do a good job. I am
going to ask you, as someone who I think will be Secretary, to
have someone who really follows this on a day-to-day basis so
we don't get lost in wonkishness and so on. We really do have
to have national standards, lessons learned from the VA.
You know how to set up the process. Blumenthal knows how to
do it. There is a great sense of urgency for the private sector
to develop the products we might use. But without national
standards, we could head for a techno Katrina. I do not want to
do that, where we do a dollar dump and at the end of the day,
and we have a lot of microchips floating around but not really
the kinds of outcomes the President wants, you want, and I
believe the bipartisan effort wants.
I am going to ask you to real aggressively stand sentry on
this because the development of national health IT standards
will be the linchpin of the technology we need to get to the
policy reforms.
Governor Sebelius. Well, Senator, you have my commitment,
if confirmed, that I will do just as you asked and also look
forward to working with you and others in Congress who have
worked on this critical issue for years, who have the
expertise, who have thought about it for a good deal of time.
You are absolutely right. This has to be done right. It has
to be done well. It has to be a system that works not only for
urban communities but, as Senator Enzi has already pointed out,
our most rural areas. We can't have a system where the systems
can't talk to one another.
If it is done right, I am a believer that not only will it
lower medical errors and lower costs, but empower consumers and
providers in a way that we have not seen and unlock the
innovation for health reform in America.
Senator Mikulski. Thank you.
Mr. Chairman.
The Chairman. Senator Isakson.
Statement of Senator Isakson
Senator Isakson. Thank you, Senator Kennedy. Glad to have
you back in the chair.
Governor Sebelius, great to see you.
Senator Dole, it is a pleasure to see you again. We are
longtime friends, and I still enjoy your wit to this day.
The first question I have, being from Georgia, we recently
had the salmonella outbreak, which started in the plant in
Camilla but then spread to closings of plants in Texas and
Virginia. Because of the pervasive nature of that recall and
the number of people that passed away and were infected with
salmonella, there have been some people calling for a
separation of FDA into two different functions, from food on
one side, drugs on the other.
Do you have a position on that proposal?
Governor Sebelius. Well, Senator, I watched with interest
some of that preliminary discussion. And again, if confirmed, I
intend to be very actively involved in the debate about--I
think step one is restoring FDA as a world-class regulatory
agency. It was at one point the gold standard for regulatory
agencies not only in this country, but in the world.
I think there are serious issues that need to be addressed
within the organization to make sure our food supply, which, as
Senator Roberts and Senator Dole can tell you, we take very
seriously in Kansas food safety and safe and secure food
supply. And our drug supply is safe and secure.
So there is, again, new leadership who has been identified
for the Food and Drug Administration. I am hopeful that if the
Senate approves their nominations rapidly, we can have that
kind of enhanced leadership in place. The President has
proposed in the budget an almost 30 percent increase in
resources.
But I think that part of the challenge at this point is
that however well the Food and Drug Administration operates, we
have to have a new platform for safety and security of food and
drugs in this country. And it has to be a much more
collaborative approach with industry. It can't just be the
responsibility of Government. It has to be up and down the food
chain.
Too often we are reacting to situations. As you say, the
salmonella outbreak, today I learned that pistachios have also
been recalled. And the reaction time needs to be faster, but
also we need to involve industry in making sure that we look at
products as they move through the food chain and that there is
some collaborative operation to make sure that those supply
chains are also very involved in keeping our people safe.
So I think it is premature to discuss whether or not we
divide or keep together an agency. I think step one is
restoring the agency that has this responsibility to its
rightful purpose, which is a safe and secure food supply.
Senator Isakson. On the same subject matter, but about the
stress on FDA right now in terms of workload and some of the
problems that have existed. There is legislation that was
pending last year in the Senate and is pending again now to put
regulation of tobacco in the FDA. Would you support that? And
if so, would that regulatory authority add too much stress on
an already overly stressed department?
Governor Sebelius. Senator, I support the idea that the FDA
will regulate tobacco. The President has supported tobacco
regulation within the FDA, and I think that there is no
question, as we talk in this room about health reform, what we
know is smoking is the No. 1 cause of health-related diseases.
It is probably the most expensive cause of illnesses that land
people in the hospital.
And for the Food and Drug Administration to actually have
the authority to exercise its regulatory power and not only
have enhanced and more significant warning labels, more
information available to consumers, help to regulate the
products that are often enticing the youngest Americans to
start smoking with whether it is flavored cigarettes or a
variety of things can only in the long-term benefit our overall
health and our economy.
Senator Isakson. Well, thank you very much, and I will just
make a comment at the end because I know my time is up.
One other pending issue that will come under your
jurisdiction if you are confirmed is the whole issue of
biological pharmaceuticals and follow-on biologics, and we are
the best inventor and discoverer of pharmaceuticals that have
helped save thousands and thousands of lives. And now
biologically based pharmaceuticals are growing exponentially.
So as we deal with that whole area of oversight and
approval of those biologics, let us not forget the process that
we have for chemical compounds that has led us to be a country
that can really invent a lot of pharmaceuticals and a lot of
breakthroughs and have the incentives to recover the R&D money.
Let us make sure we do the same thing with regard to biologics.
Again, congratulations on your nomination.
The Chairman. Senator Harkin.
Statement of Senator Harkin
Senator Harkin. Thank you very much, Mr. Chairman. Let me
join with others in welcoming you back to take charge of our
committee and health reform this year.
Welcome to Governor Sebelius, and congratulations on your
nomination for this very important position.
I apologize for being here late and having to leave early,
but right now I am chairing another hearing on agriculture on
the reauthorization of the child nutrition bill this year. That
has to do with our school lunches and school breakfasts, which
Senator Dole has been such a great leader on all his lifetime,
and trying to get junk food out of our schools and get more
healthy and nutritious food for our kids in schools.
Now, while that may not be directly in your jurisdiction, I
certainly hope that you will work closely with Secretary
Vilsack and Secretary Duncan in helping us get this bill
through that will get the junk food and sugary sodas out of
schools and get healthier foods in our schools for our kids.
I hope you will be involved in that, even though it may not
be directly under your jurisdiction. That is my way of saying
that is why I have to leave a little early.
But I am really delighted to see you here with Senator Dole
because my first question has to do with an issue that both of
us have worked on for a long time, him a lot longer than me.
Senator Kennedy has also been a great champion of disability
issues.
As you know, we passed the Americans with Disabilities Act
in 1990. Shortly after that, we started a process to try to
address the issue of people with severe disabilities and the
fact that they are shunted into nursing homes.
When I tell people this today, they say I must be mistaken
when I tell them that right now if you are a person with a
severe disability and you are eligible for Title XIX under
Medicaid, Medicaid must, must pay for your institutional
setting in a nursing home. If you want to live in your own home
or in a community setting, they don't have to pay for it. And
so, Medicaid forces people with disabilities into nursing homes
where they may not want to be.
So, we started shortly after that, Senator Dole and I and
others, in the early 1990s pushing a bill, which we called the
Medicaid Community Tenant Services and Supports Act. The people
in the community knew it as MiCASSA. But we could never get it
through because they said it was going to cost gazillions of
dollars.
Well, since that time, we have had further studies done,
and we know now that it doesn't cost that much. And so, we now
have a new bill. We call it the Community Choice Act, to give
people with disabilities the choice. Do they want to live in a
nursing home, or do they want to get their services and
supports in their own home or in their community, near their
families, near their friends?
Then 10 years ago, 10 years ago this year, we had the U.S.
Supreme Court decision in Olmstead, the Olmstead case, in which
the U.S. Supreme Court said that people with disabilities have
a constitutional right to live in the least restrictive
environment. That was 10 years ago, and we still haven't taken
care of it. It is just hanging on us.
I would just like to ask if you would support the Community
Choice Act as well as the U.S. Supreme Court decision in
Olmstead as we do healthcare reform? To make sure that in
healthcare reform that people with significant disabilities
have the choice and opportunity to receive their supports and
services within their own homes and communities rather than
just in institutional settings.
Governor Sebelius. Well, Senator, I am not familiar with
all of the provisions in the act, the Community Choice Act.
What I can tell you, though, is that Kansas has been fairly
aggressive as a State in pursuing Medicaid waivers to ensure
that money does follow those of our disabled citizens who want
to live in a less restrictive setting.
We have addressed the challenges--some would say not
enough, there is more work to be done--but the challenges of
building a workforce, a competent workforce who is available to
take care of citizens in a less restrictive setting,
particularly those with severe disabilities. We have enacted
legislation that has actually closed two of the hospital
settings and moved those resources into communities.
So I am very much committed to actually following the
dictates of the Olmstead Act. And as we address health reform,
I think it is critical to look at citizens at all ends of the
spectrum, those who are very healthy and those who are very
disabled, and find the best possible avenue for support and
health outcomes.
I don't think there is any question that people prefer to
live in less restrictive settings. And so, we have workforce
challenges. We have financial challenges. But it is one that I
am very familiar with and believe in very strongly.
Senator Harkin. I appreciate that, but the ultimate
decision ought to be with the person.
Governor Sebelius. That is right.
Senator Harkin. The person ought to decide, not Medicaid or
CMS or anybody else. If that money can flow to a person to go
to an institution, it ought to flow to that person regardless
of where that person wants to live. And that is really the
essence of the Community Choice Act.
Governor Sebelius. Well, I promise, if I am confirmed, I
will definitely take a look at it and work with you to see what
we can do with the Medicaid system to make that happen.
Senator Harkin. I appreciate that. I would be remiss if I--
no, I don't have any time left. OK. I will submit my other
questions in writing.
Governor Sebelius. I do want to, though, also--if I can,
Mr. Chairman? The Senator began his comments with a very
critical issue, and I think it is one that is so tied to the
topic, that sort of the umbrella topic of today's hearing,
which is health reform. Certainly addressing childhood obesity,
addressing the health of our children is a critical component
of this.
We have the first generation of children in America, if the
statistics continue, who will have shorter expected lifespans
than their parents, first time ever in the country. It is a
rampant crisis that we need to address.
I, again, congratulate you for your work on school
nutrition, for wellness and prevention work. But addressing the
responsibility that we have to take some action outside of
ensuring that Americans have access to healthcare, I think we
need to have some personal responsibility re-instilled.
Individuals have a responsibility about what they eat, how they
exercise, and what kinds of choices they make with particularly
tobacco.
The more we can drive that through the auspices of the
agency through prevention efforts, I think the better off we
are going to be in the long run.
The Chairman. Thank you very much.
Senator McCain.
Statement of Senator McCain
Senator McCain. Congratulations on your nomination,
Governor, and we look forward to speedy confirmation.
And Senator Dole, it is wonderful to see you back again as
always. We miss you every day.
Governor, I would like to discuss with you for a moment the
issue of employer-provided health insurance. As you know, the
employer-provided health insurance is a result of World War II,
when price and wage controls were imposed. So employers
provided additional healthcare benefits, and those are tax
free.
First of all, would you agree with me that there is a
certain unfairness associated with this in two ways? One is
that traditionally, the higher up in the food chain the
individual is, the more benefits and the more likely gold-
plated insurance is provided. Also, small business people are
generally unable or certainly large numbers of them are unable,
because they are small business people, to provide health
insurance policies to their employees.
Would you agree with that premise?
Governor Sebelius. Well, Senator, I certainly agree that in
the marketplace, those who are self-employed and those who are
small employers are often priced out of the market. Yes, sir.
Senator McCain. Well, do you agree with my first point or
disagree?
Governor Sebelius. Well, I think there is no question that
employer-based health insurance is the backbone of the health
insurance system we have right now.
Senator McCain. My question was whether you agree or
disagree that employer-based health insurance generally is much
more generous to the upper-level management in American
corporations and businesses?
Governor Sebelius. Well, I am not familiar with
differentials in the health system. I know in a State employee
system and a manufacturing operation that the workers have good
benefits, and I think they don't differ from the benefits of
the executives in those systems.
Senator McCain. Would you support removing the tax
exclusion and substitute a refundable tax credit of, say,
$5,000 per family so that they can go out and purchase their
own health insurance policy of their choice?
Governor Sebelius. Well, Senator, I support what the
President has articulated, which is that----
Senator McCain. You know we are asking for your views
before this committee, Governor.
Governor Sebelius. I support what the President has
articulated, which is that if Americans have health insurance
that they like, they should be able to keep it. Dismantling the
current system of employer-base coverage, to me, is not the
most effective strategy to reach full coverage for every
American since so many of our Americans currently rely on
employer-based coverage.
Senator McCain. A lot of people view some of the proposals
by the Administration as a Government-run health plan that
would be made available to all Americans. Do you support the
creation of a Government-run health insurance plan?
Governor Sebelius. I don't support the notion that the
Government would run the health insurance plan, and I think,
again, back to your earlier question, starting with the
platform that we have, where the vast majority of Americans
with insurance have employer-based insurance, a number of
people are involved in public insurance. And then the question
becomes how to close that gap? How to deal with the 15 percent
of Americans who don't have coverage?
And I see that as a public-private----
Senator McCain. So you do not support a creation of a
Government-run health insurance plan?
Governor Sebelius. Senator, I----
Senator McCain. These are pretty straightforward questions,
Governor, I would think.
Governor Sebelius. Well, if you are talking about insuring
all 15 million Americans in some Government-run plan, no. I am
talk----
Senator McCain. No, I am not asking that. I am not asking
that. I am asking you----
Governor Sebelius. Maybe I don't understand you.
Senator McCain [continuing]. If you would support the
creation of a Government-run health insurance plan?
Governor Sebelius. If the question is do I support a public
option side by side with private insurers in a health insurance
exchange, yes, I do.
Senator McCain. Thank you.
I thank you very much, Mr. Chairman.
The Chairman. Senator Murray.
Statement of Senator Murray
Senator Murray. Mr. Chairman, let me say it is great to
have you back and in charge of us. Enjoy seeing you here today.
Thank you.
Governor, it is wonderful to see you here today. Thank you
so much for being willing to take on this tremendously
important job at this time in our Nation's history when we are
facing a terrific economic crisis. And the issues that fall
under your jurisdiction, should you be confirmed, are essential
to our economic recovery and very complex. So thank you very
much for your willingness to do this.
Healthcare obviously is the issue that everyone knows needs
to be addressed. And one of the parts of healthcare reform that
I am sincerely worried about is the shortage of healthcare
providers we have today. As our baby boomers are retiring--many
of them in the health professions, leaving it--and then
becoming part of the generation that requires the most
healthcare workers, we have a real lack of healthcare workers
today.
I have held a number of roundtables around my State on
healthcare, and every single one of them talk about the fact
that we don't have enough doctors, nurses, and healthcare
providers. So I wanted to ask you today about how we can find
and train and recruit workers into the healthcare field, even
beginning back in middle school and high school years?
Governor Sebelius. Well, I appreciate that question,
Senator Murray, and I appreciate your leadership in this area
because it is absolutely critical. I think that the Congress
made a major step forward with the Recovery Act, providing
additional resources for the pipeline of health workers,
expanding the HealthCorps, looking at ways we can make sure
that there are more providers, particularly in our most
underserved areas.
But the challenge of getting more of our young people
involved in math and science at an earlier age and making sure
that medical professions and other scientifically based
professions are attractive to our youngest students is, I
think, an additional challenge we have across America that we
haven't--we have sort of lost that focus in our earliest
learning and in our schools.
I can tell you, as a Governor, it is a challenge that my
colleagues and I took on as an initiative a couple of years
ago, working with not only school systems, but providers across
the country to re-
invigorate science and math curriculum to make sure that those
pathways were open. Because you are absolutely right--if you
don't decide until you are in high school or sometimes in
college, you then have a lot of makeup work to do. We need that
pathway to be built.
Senator Murray. I think it is a part of healthcare reform
that we can't--as we do healthcare reform--we can't lose sight
of. If there aren't enough doctors or nurses, the cost of
healthcare goes up, particularly in our more rural communities.
So I believe it has to be part of healthcare reform.
Governor Sebelius. Well, I also think part of the challenge
and part of the solution may be to change the payment
incentives. I mean, right now, it is not only how many health
providers we have, but how few providers there are in family
practice and in family medicine and in preventive medicine, as
opposed to specialty areas.
I think it is both the numbers overall, but it is also
refocusing, hopefully, the payment incentive so that primary
care becomes a much more lucrative profession. It is rewarded
as the front end of the system. It strikes me as that is where
we need a lot of the focus. If we intervene earlier, if people
have a health home, if we focus on prevention and wellness, we
won't need as many specialists at the end of the day.
Senator Murray. I hear about primary care, a lack of
primary care physicians everywhere I go. So I appreciate that.
Let me ask you about, speaking of payments, Medicare
payments to physicians. That is modified annually using a
formula known as the sustainable growth rate, SGR. That is the
system of reimbursement that is based on a very outdated scale
that came about from looking at cost-of-living and healthcare
costs and patient utilization.
That formula is a real detriment in many of our States,
including mine, because over time we are being reimbursed
because we have less utilization. We focus on healthy outcomes
rather than how many times you go to the doctor. And over time,
our State reimbursement for Medicare is much lower than some
other States that focus on higher utilization.
We have doctors now who are not seeing Medicare patients
all across our State. I know other States are seeing that as
well. And I would like to find out from you how you think we
ought to address the current SGR formula so that it can more
actively reflect better healthcare outcomes?
Governor Sebelius. Well, Senator, I appreciate that
question. It won't come as a big surprise to you that I have
heard about this issue every place I have gone. And certainly
in conversations with providers, it is a huge looming cliff.
The SGR cut that is proposed to be enacted next year would
reduce provider rates by over 20 percent, clearly unacceptable.
Let me just say if I am confirmed as Secretary, that will be a
top priority to work with those of you in Congress to address a
long-term solution.
I do believe as part of health reform, Medicare can lead as
by example. And part of the leadership will require a
reconfiguration of the overall payment system. SGR is part of
it, but only a piece of it, as how we redirect those payments
to reward appropriate care, great outcomes, preventive care, as
opposed to what we are doing now, which, as you suggest, is
more about patient contact than patient outcome.
I think we have a huge opportunity with the Medicare system
to not only redesign and address the SGR itself, but to also
re-
design a whole payment system that redirects care to our senior
population and the disabled population relying on Medicare
services in a much more cost-effective and patient-effective
manner. Better health outcomes and lower costs.
Senator Murray. OK. Thank you very much. My time is up.
Thank you, Mr. Chairman.
The Chairman. Senator Coburn.
Statement of Senator Coburn
Senator Coburn. Mr. Chairman, welcome back. It is good to
see you.
Governor, thank you for being here. Congratulations on your
nomination.
I want to clarify something you said earlier, and this is
your quote. ``We cannot fix this economy without fixing the
healthcare system.'' Are you implying that we can't recover
from this recession unless we do major reform to the healthcare
system?
Governor Sebelius. Senator, I think it is so intimately
tied to a lot of our economic challenges that I think reforming
the healthcare system puts us on a pathway to a sustainable
long-term, prosperous economy.
Senator Coburn. But you are not saying that if we didn't do
it, we wouldn't recover from this recession?
Governor Sebelius. I am very hopeful that we are on a
recovery mode from this recession. But as I listen to business
executives, as I listen to health providers, as I listen to the
families across Kansas and across America, the current rate of
growth of healthcare costs is unsustainable. And I do think it
is a component of fixing the overall economic future for this
country.
Senator Coburn. First of all, let me clarify, Senator
McCain was not proposing eliminating employer-based health
insurance. I hope you understood that. That was not the intent
of his question.
The second point, I want to identify with Senator Mikulski.
Health IT is important, but it is only important if we have
interoperability. Do you have plans to disband the 501(c)(3)
that is set up to do the certification now that Secretary
Leavitt set up, the private board that is doing that
certification and moving us toward interoperability?
Governor Sebelius. Senator, I have to confess I am not
familiar with the 501(c)(3). I know there is a----
Senator Coburn. Well, it is set up now as a public-private
corporation that is actually making the decisions about
interoperable standards, and they have moved this from the 20
percent we had to about 60 percent, and a goal that in 2012 we
will have 100 percent interoperable standards.
Is it your intention to let that continue to run, or are
you going to interrupt that and do something different?
Governor Sebelius. Senator, as you know, I am not confirmed
as Secretary yet. I plan to take health IT as an important
challenge and a preliminary challenge. Dr. David Blumenthal has
just been named----
Senator Coburn. Well, let me ask you, just to answer that,
if you will go back and look at that?
Governor Sebelius. I would be very happy to do that.
Senator Coburn. And I plan on submitting several questions
for the record. I would like to come back for a second round. I
have a meeting here in just a minute.
Would you agree that our biggest problem for access is
cost?
Governor Sebelius. Yes.
Senator Coburn. All right. So if cost is the biggest
problem to access, why are we wanting to raise $1.3 trillion or
another $130 billion a year for Government funding for
increased access when we really should be working on decreasing
the cost rather than increasing the expenditures? The Obama
plan takes us from 17 percent of our GDP to 19 percent based on
the money that they are ``reserving'' in the Obama budget for
that.
If the biggest problem is cost, why aren't we working on
cost rather than increasing the amount of expenditures?
Governor Sebelius. Well, Senator, first of all, I am not
sure of the figure. I know that President Obama's budget lays
out a $634 billion reserve fund that is entirely paid for, and
he has suggested that that is not sufficient. So that is the
number I am more familiar with.
I do think that, like a lot of the experts feel, that we
may have a short-term bell curve in spending increase before we
can incur the long-term savings, cost savings that will come
with a total shift in our healthcare system. I am one who
believes that there is enormous cost benefit in fully enacted
health IT. But we won't see that before we have that in place.
Senator Coburn. We won't see that until 2015 at the
earliest.
Governor Sebelius. Well, you may----
Senator Coburn. Let me move on to another question.
Comparative effectiveness was in the stimulus package. We spent
$780 million last year through NIH and AHRQ for vigorous
comparative effectiveness research--long-term, controlled,
double-blinded perspective studies. And they have had a
marginal impact on practice.
Not because doctors aren't willing to follow it, it is
because there wasn't a clear decision made out of those long-
term studies. What makes you think that on very short-term
studies that we can come and have answers that are going to be
better than the long-term studies that we are funding now that
we can all of a sudden decide which way to go?
Governor Sebelius. Well, Doctor, you are a healthcare
provider. So you are familiar with best practices and keeping
up to date on what the strategies are that are the most
effective and also, as we talked about, knowing about the
training and individualized oversight that providers have with
their patients.
I think having the best possible research, comparative
research on alternative interventions to inform not only
healthcare providers across the country about what works and
what is the most effective strategy, but health consumers. We
are talking about informing consumers and having individuals
learn more about their health outcomes and take more
responsibility.
And it seems to me that having the research available,
having the research in a transparent fashion, and having the
research developed across the country is a very important piece
of making sure we are getting the best possible outcomes for
the people of America.
Senator Coburn. Thank you, Mr. Chairman.
I would like to follow up in the second round, if I may?
The Chairman. Senator Dodd.
Statement of Senator Dodd
Senator Dodd. Well, thank you, Mr. Chairman. Let me join my
colleagues and welcome you to the committee once again. We
missed you terribly and it is great to have you back here with
us, leading us again.
And congratulations, Governor. We have had a chance to
talk, and you are in the best possible company with Bob Dole.
So, Bob, welcome back to the committee once again and for
your leadership and your service here.
I would like to raise, if I can--first of all, I think we
are very fortunate, indeed, that you are willing to do this,
Governor. And your experience as insurance commissioner,
Governor, State representative brings a wealth of experience to
this job, and obviously, your knowledge of the issues is
tremendously important. So we look forward to working with you.
And Mr. Chairman, I would ask consent to have a full
statement of mine included in the record, if I could, regarding
the nominee?
The Chairman. It will be included.
[The prepared statement of Senator Dodd follows:]
Prepared Statement of Senator Dodd
Thank you Chairman Kennedy. I want to welcome and
congratulate Governor Sebelius on her nomination to be
Secretary of the Department of Health and Human Services (HHS).
Having served on this committee for 26 years, I can't
recall another time when the challenges facing the Secretary of
HHS were so complex. Our economy is in the worst shape it has
been for decades and we have a health care system that is
broken--impacting our families, our businesses and our
competitiveness as a nation. The Department of HHS and health
agencies are in desperate need of attention and leadership. It
is critical to restore the Department to one whose decisions
are based on the best available science, not the political
ideology of the moment.
President Obama has already made tremendous progress here
with the signing of an Executive order overturning President
Bush's harmful restrictions on embryonic stem cell research and
the signing of a Presidential Memorandum on scientific
integrity. And, he has moved quickly to appoint highly
qualified candidates such as you to key positions within the
Department such as FDA Commissioner and HRSA Administrator.
Governor Sebelius, you bring a wealth of experience working
in a bipartisan fashion to improve the lives of families. The
knowledge and expertise you gained as Governor, Insurance
Commissioner, and State Representative will be instrumental in
achieving comprehensive health care reform--reform that at long
last makes health care accessible and affordable for all
Americans.
The case for reform of our health care system has never
been stronger. Over the last few months I've been holding a
listening tour on health care around Connecticut. More than
1,500 people from all walks of life across the State have shown
up at these events and have told me about the challenges they
face to accessing necessary, quality, affordable healthcare.
And although there are some disagreements about solutions, they
have all told me we must reform the health care system. It is
my hope that you will join me for one of these events in
Connecticut.
It is often said that Americans have the best health care
in the world and for many Americans that may be true. But how
effective can that system be if rising costs to families make
it unaffordable and inaccessible to millions of Americans? In
my State, health care premiums have shot up 42 percent in the
last 8 years--in the last 2 years, nearly 1 in 10 of our people
have had no health insurance at all.
And how can we have a world-class health care system if
high-quality care and value are inadequate in many parts of the
country despite $2 trillion in annual health care spending?
At the same time, our health care system is failing
millions of our Nation's children and adolescents. The United
States is a leader among industrialized nations in infant
mortality, affecting African-American babies at more than two
times the rate as non-Hispanic white babies. That is
unacceptable.
Our system is creating a generation of children who may
well be the first generation of American children who will live
shorter, less healthy lives than their parents. That, too, is
unacceptable.
This is happening, in part, because our system is driven
not by the prevention of illness and disability but the
treatment of illness and disability. It's completely
backwards--and it has to change. And with your leadership and
the work of this committee, I believe it can and will change.
Since the beginning of this Congress, and even before, the
members of this committee have been preparing to work with our
colleagues and the President to reform our health care system.
The President made clear in his address to Congress and in his
budget that reform must happen this year. Chairman Kennedy and
Finance Committee Chairman Baucus are working to get this done
this summer--and I am proud to support them in that endeavor.
Bipartisan discussions, though at an early stage, are underway.
This week the Senate will debate a budget resolution that
allows for this committee and the Finance Committee to report
out health reform legislation. And I know that you, Governor
Sebelius, will be a tremendous partner for us in this effort.
While health care reform is a top priority for me and for
this entire committee, I also want to address another vitally
important issue and a responsibility of the Department--early
childhood education and development. This is an issue that has
long been near and dear to my heart. I am encouraged by the
commitment President Obama has made to early childhood
education, and I look forward to working on new proposals as
well as strengthening current programs like Head Start and
CCDBG to benefit our children and their families. An investment
in our youngest Americans pays off in their readiness for
school, their health, job creation now and in the future, and
the need for fewer social services later in a child's life.
Governor, given the challenges facing this huge--oftentimes
disparate--Department, it is my hope that your team will be in
place as quickly as possible. As I mentioned, I am pleased that
the President has nominated a Commissioner and Deputy
Commissioner for the Food and Drug Administration, as well as a
new administrator for the Health Resources and Services
Administration. I also want to encourage the swift selection of
leaders at the National Institutes of Health and Centers for
Disease Control and Prevention. And I look forward to working
with Chairman Kennedy to help move these nominations as
expeditiously as we can.
I believe you will make an outstanding HHS Secretary,
Governor Sebelius, and have no doubt that you will serve our
country and President Obama well in this role as you have in
every other position you have held. And I look forward to
working with you, Chairman Kennedy, and my colleagues on the
committee to bring meaningful, lasting change to our Nation's
health care system in the months and years to come.
Senator Dodd. Let me just focus, if I can, on children.
Obviously, the matters that we have dealt with here recently,
with the CHIP reauthorization, have been tremendously helpful.
Although even with that, there will be a number, a significant
number of children who are still left out of the healthcare
system.
I am looking at a report this morning that you may have
seen, may not have seen. This is a study on late pre-term
births, a cause for concern. Senator Lamar Alexander and I
wrote premature birth legislation in the previous Congress to
try and put some resources into this general area. And
obviously, these studies here, average expenditures for
premature low-birth weight infants were more than 10 times
higher than uncomplicated newborns.
This study talks about babies born just a few weeks
prematurely are more likely to have developmental and
behavioral problems later on as well as health issues than
those who arrive closer to full term. The study was released on
Monday from very respected sources on this subject matter.
There has been this notion for years, of course, that
children are just small versions of adults, and therefore, what
most of us grew up with at a time when there were limited
pharmaceutical products and so forth, for children, it was just
dividing aspirins in half and quarters and so forth. And we
have learned over the years, as a result of legislation here
under the leadership of Senator Kennedy and others, that we
need to deal--the physiology of children is very different than
adults, and we need to deal with them accordingly.
I just wonder if you might take some time and talk a little
bit about this. I think it is a tremendously important area. I
note that I think the deputy now of FDA is going to be a person
with a strong background in pediatrics. And, in particular, he
understands the needs of children and including providing
benefits for maternal care.
In light of these studies with premature births, it seems
it ought to be an important part of healthcare formulation, and
I wonder if you might address that issue.
Governor Sebelius. Certainly, Senator. First of all, I
think there is no question you have been one of the Nation's
leaders on children's issues, on family issues, on making sure
that whether it is childcare or the Family Medical Leave Act or
a whole variety of areas, we keep children as the No. 1 focus.
And once again, you have identified a critical cost-
effectiveness strategy.
If we provide and if we identify women early on in their
pregnancies and they have adequate and routine prenatal care,
the likelihood of delivering a full-term baby at adequate birth
weight is significantly different than if a woman has no
prenatal care and shows up in the delivery room for a first or
second visit. That not only is a huge cost issue but, as you
have identified, is a huge quality of life issue.
Children born prematurely have all kinds of struggles,
health struggles, mental health struggles, long-term health
issues, not to mention just the cost of ICU care, which often
is borne by Medicaid budget. So I think that the President
understands this challenge very well. Not only, as you suggest,
has he nominated a deputy at FDA who is a pediatrician and
comes from that background and those sensitivities, but also in
his 2010 budget outline, blueprint, there is a proposal for a
nurse visiting program.
A visit early on in a pregnant mother's care, identifying
at-risk moms, trying to follow up on them on a regular basis,
getting the kind of care and assistance needed along the way.
There is study after study which indicates those are very
successful programs. Successful in terms of health outcomes and
very successful in terms of cost reduction. So I think the
President has identified one pathway.
We in Kansas have had a Healthy Start-Healthy Kansas
strategy that not only helps to follow moms but has the
visitation at the stage when the mother leaves the hospital.
First-time at-risk mothers, again, we know have challenges and
issues that need to be dealt with. So having healthcare wrapped
around that very important time I think is very effective for
the children, very effective for the mothers.
Senator Dodd. Well, I thank you for that.
This study pointed out there is a 40 percent cost savings
for every week that a delivery is delayed in getting close to
the due date, 40 percent per week, which is a remarkable
savings. Senator Coburn talked about cost savings. That if you
can really deal with a premature birth issue in an effective
way, it is not only obviously in terms of developmental issues
for that child and the pressures on that family, but for those
who are only impressed about the cost issues, this is certainly
a way to make a difference.
I would be remiss----
Governor Sebelius. And as you know, Senator, overall health
reform helps that because if we have access early on, if
Americans have health homes, have a doctor who they are seeing
on a regular basis, the likelihood of having good prenatal care
throughout a pregnancy is significantly higher than the
situation we have right now.
So health reform really goes to the heart of that issue to
make sure that all pregnant mothers would have access to high-
quality care.
Senator Dodd. And the obesity issues, cessation of smoking
issues, all of these other matters that do contribute to
premature birth and low-birth weight babies obviously have a
huge impact as well in all of that.
One statistic that always just bothers me more than almost
any other one we talk about when we are talking about
healthcare, and that is that the United States has the highest
infant mortality rate of any industrialized country in the
world. That ought to be just a source of collective shame.
I mean, the fact that this country with all of its assets
has that statistical record is something we have got to come to
terms with, and with all--well, anyway, the statistic speaks
for itself.
I just wanted to mention as well, you mentioned childcare
and the Childcare Development Block Grant. That only happened
about 20-some odd years ago because the fellow sitting next to
me and the fellow sitting next to you in the majority leader's
office that day decided to work it out so we could start the
Childcare Development Block Grant.
And Senator Ted Kennedy and Senator Bob Dole made all the
difference in the world 25 years ago on that issue. So since
you brought it up, and I was the author of the bill, but it
never would have happened had it not been for these two
gentlemen. So thanks.
The Chairman. Well, I think all of us know that Senator
Dodd was the leader on that issue, and we all are grateful to
him as well for the other many healthcare issues. So we thank
you. Thanks very much.
Senator Dodd. Thank you, Senator.
The Chairman. Senator Murkowski.
Statement of Senator Murkowski
Senator Murkowski. Thank you, Mr. Chairman. It is nice to
see you up on the dais here this morning.
And welcome, Governor. I appreciate your willingness to
step into this position. It is incredibly important, as we all
have mentioned.
I want to talk a little bit about access this morning. You
and I had an opportunity to chat about this when you visited
with me. I had a conference call last week and brought in about
a dozen primary care doctors, some mid-level providers, and was
asking them about the issue of access for Medicare
beneficiaries. I asked them to give me a couple of legislative
fixes that they would suggest.
Almost unanimously what these providers said that they had
been hearing from their Medicare patients is that they simply
wish that they could opt-out of Medicare and into private
insurance. After that conference call, I had a tele-town hall
meeting, with about 4,000 Alaskans that were speaking on the
issue of access to Medicare and I heard the same refrain, which
I find absolutely stunning.
You pay into the system your whole working life, and they
are now at the point, as retirees, where they are saying I am
prepared to reject a program, forgo the benefits, just so that
I can have access to a medical care provider.
In Anchorage, our largest city, we have a situation where
we have providers that are no longer accepting Medicare-
eligible individuals. One in ten is not taking any new
Medicare-eligible patients. So we have a situation where we are
talking about all the great things that we are going to be
doing here in Congress on healthcare reform, but I don't have
providers that are willing to take any new or existing
Medicare-eligible individuals.
This is a huge issue for us, and it is not just in Alaska.
It is not just in rural America. When Senator Daschle was doing
his healthcare tour, he heard the same things when he was in
Dublin, IN, last December. The MedPAC, the Medicare Payment
Advisory Committee, estimates that 17 percent of all seniors
nationwide had significant problems accessing primary care
healthcare services.
So I guess my question to you this morning is this: We
clearly have very serious problems when it comes to the
reimbursement issues that we have discussed, access, making
sure that you have providers that will accept those that are
Medicare eligible. How do we strengthen this Medicare program
so that when you have that Medicare card it also means that you
have access to care?
Because right now, in the largest city in my State, having
that Medicare card means nothing because patients can't get
into a primary care provider. And right now, they can't. So
what do we do?
Governor Sebelius. Well, Senator, I appreciate your
concern, and it is a huge concern and one that I share.
Clearly, having a card does you little good if you can't see a
doctor and can't get the care that has been promised to you by
that card. So the issues of access in your State, in parts of
rural America, in areas of the country where access is a
problem need to be addressed, and I can assure you, if
confirmed, I would love to work with you on that.
It is my understanding that in Alaska there has been a
fairly recent payment adjustment, and I am hopeful that you may
see some relief in the access issue based on that. But I think
addressing, as we move forward, what are the various reasons
that providers are not opting to take Medicare patients--if it
isn't a payment situation, what are the other additional
factors--is something that I just can commit that I would be
eager to work with you to try and resolve.
Senator Murkowski. So much of it is the payment side. It is
the reimbursement side, and we hear that time and time again.
And yes, you are correct. We were able to get an increase
in reimbursement effective the first of the year. What we are
seeing, interestingly enough, is physicians are not taking on
new Medicare-eligible individuals. What they are doing is as
their existing patients are aging into Medicare, they are
keeping them on.
What we were seeing last year was folks who had gone to the
same provider for 10 or 15 years, are fine so long as they
don't hit that magic age of 65. But when that birthday rolls
around, their doctor tells them, ``I am sorry. I am not able to
see you.'' We think that we may have stemmed that. That, in
fact, they are willing to keep their existing patients on.
But we are not able to add anyone new, which is a very,
very serious problem. And unfortunately, we are not seeing it
really get better. So we need to be working with you on this.
We need to be addressing the increased healthcare cost that we
face in a rural State like Alaska and addressing reimbursement
that is a reasonable reimbursement rate.
I would extend the offer to you to come up and see some of
the challenges that we face, as well as some of the remarkable
achievements that we have made in delivering healthcare through
telemedicine and just being smart with what we do with limited
healthcare dollars. But we do need some help, and we will look
forward to the opportunity to be working with you.
Thank you.
The Chairman. Just a point. I want to say about Senator
Murkowski, it isn't just the States like Alaska. This is a
problem that is all over the country. And we have about 8 to 10
individual openings for qualified people for nursing and for
other professionals in this area, and there is a critical
national need, and I am glad you mentioned this. It is
incredibly important to Alaska and to other States. Thank you
for bringing this up.
Senator Reed.
Statement of Senator Reed
Senator Reed. Thank you very much, Mr. Chairman.
Welcome, Governor, and I look forward to you assuming these
responsibilities. Your judgment, your experience, both as an
insurance commissioner and a Governor, really puts you
extraordinarily prepared to lead on the most important issue we
face within the country, which is healthcare reform and other
issues you will address.
The cost of not reforming our healthcare system is
demonstrated in many ways. One way is the increasing burden
that hospitals are bearing because of uncompensated care. In my
State, it is estimated a 40 percent increase since 2005 in just
uncompensated care--free care, essentially--by hospitals. They
can't sustain this.
If we don't respond, we are going to have a situation where
our hospital community begins to implode. So I wonder if you
have any ideas along the lines specifically with respect to
hospitals in terms of healthcare reform?
Governor Sebelius. Well, Senator, I think you are
absolutely right that the hospital system is being crunched.
Not only the people who are coming through the doors of
emergency rooms accessing care that often is uncompensated, we
have people in trauma centers who end up for lengthy and very
extensive periods of time that are uncompensated.
We have, as Senator Dodd just talked about a little bit, in
I would say ICUs across this country, babies who are born at
precariously low-birth weights who now, through the miracles of
modern medicine, are able to live. But often the cost of those
lengthy stays in the hospital is, if not uncompensated,
undercompensated.
The hospital is often in a situation where they are really
struggling to survive. And what I know in a State like Kansas,
and I am sure it is true in every State in the country, if you
close the hospital, you close the town. People will not choose
to live in an area where they can't have access to healthcare.
So, clearly, providing a payment system, a reasonable
payment system for everybody who accesses hospital care will
greatly reduce not only the burdens that currently are on those
who have private insurance. It is estimated about 16 cents of
every dollar of private insurance coverage pays for
uncompensated coverage. So those with insurance are currently
bearing an additional cost.
But also reduce dramatically that strain on hospitals who
deliver critical care to the insured and the uninsured. I mean,
the notion that a hospital would close because of uninsured
care, therefore jeopardizing long-term coverage for those who
are insured is the worst of all worlds. And I think that is the
situation we find ourselves in.
Senator Reed. Let me ask you a related question. As we
expand healthcare, as we reform healthcare, we need the
healthcare professionals to do that. This raises two issues,
Title VII, which is the Health Professions Act, which we have
worked under the leadership of Chairman Kennedy to strengthen
and to expand.
Also just generally graduate medical education, a new model
so that we have practitioners who are generalists rather than,
in some cases, the overabundance of specialists. Your thoughts
on those two topics?
Governor Sebelius. Well, Senator, you have pretty well
articulated the situation--not only the need for the pipeline
of health professionals to deliver care, but a shift in the
training and the expertise of those professionals so that we
essentially grow the market of primary care, of family docs, of
folks who are going to be on the front end of prevention and
wellness and early intervention.
That is in part a payment system. It is in part addressing
some of the situation that is in the current Medicaid proposals
that are pending dealing with a change in the payment for
graduate medical education. There is a step in the recovery
bill addressing the workforce issues. One of the things that we
found in our State, and I am sure is true across the country,
is that we are not only talking about doctors, but in many
cases, talking about nurses.
The nurse profession is often delivering primary care and
is on the front lines. We can't train more nurses unless we
have more nurse faculty. So it really is a multi-pronged
approach, a comprehensive approach, but one that, if confirmed,
I can assure you is one that I have worked on as Governor and
one that I would certainly continue to work on as Secretary.
Senator Reed. Thank you very much, Governor. Thank you.
The Chairman. Senator Burr.
Statement of Senator Burr
Senator Burr. Thank you, Mr. Chairman.
Governor, welcome.
And Senator Dole, before he leaves, Senator, good to have
you here as always, and we are delighted you would come and
spend your time to introduce the Governor.
Senator Dole. I want to congratulate you on your being man
of the year----
Senator Burr. Thank you.
Governor, I think I heard in your answer to Senator Reed,
and I just wanted to re-cover it, that the disparity in
reimbursements causes the low number of primary care docs and
people to choose other specialties. I think until we are
willing to address reimbursements and actually reimburse
primary care in a sufficient way, you will continue to have med
students that when they get through with their visit to the
bank, as they begin to borrow money for medical school, decide
that a specialty gets that student loan paid off faster.
And for a primary care physician, it looks more like an
amortization for a home mortgage, and I hope we can work on
that.
I have two very specific questions. The national average
monthly premium for basic 2009 Medicare drug benefit is
targeted to be $28. That is 40 percent below what we projected
for Part D in 2003, when we created it. Given that the program
has held down cost to beneficiaries, do you think that this
competitive model should be considered in the context of the
overall healthcare reform that we are going through?
Governor Sebelius. The way that Part D is constructed,
Senator?
Senator Burr. Correct.
Governor Sebelius. First of all, I don't think there is any
question that having a prescription benefit for seniors was
long overdue and hugely important to the medical care of
seniors across this country as we have shifted in the health
system from longer hospital stays, which used to be the norm 10
years ago, to often preventive drug applications. Not having
that health benefit was extraordinarily difficult for many
seniors in this country.
I think there are some issues about Part D, which, if
confirmed, I would look forward to working to help resolve. Not
the least of which is the design construct of the program, the
so-called donut hole, which often is very difficult for seniors
who have budgeted certain amounts and, as you say, have now
relatively low premiums at the front end only to hit a
situation where they have no coverage for a period of time in a
drug use.
Senator Burr. Under our own design, we knew there were
flaws----
Governor Sebelius. Yes.
Senator Burr [continuing]. To the overall product. What we
didn't anticipate was that the level of competition you put in
Part D by design would drive down the premium of the basic Part
D. And I would just encourage you that I think on both sides of
the aisle we were shocked at this. We continue to be shocked at
it, and the element of competition has to be an important
driver in the context of overall healthcare reform.
Last question. Ryan White Care Act is up for
reauthorization this year. Do you believe that it is important
that Ryan White money follow HIV-infected individuals?
Governor Sebelius. Well, Senator, I don't think there is
any question that that money is essential, and it is important
as the reauthorization discussion goes on. And again, if
confirmed, I look forward to having an opportunity to look at
the comprehensive strategy that we address to patients in
various parts of the country and make sure that they have
access to assistance.
I think there are some alarming data. I saw recently that
in Washington, DC, they are now projecting that the HIV rate is
over 3 percent, which is regarded as an epidemic level. So I
think we have some real challenges, whether it is parts of the
country that have a smaller number of patients that don't have
as much access to help and support or areas where we have a
huge epidemic.
The reauthorization, Senator, I think gives us an
opportunity to look comprehensively at the best strategy moving
forward.
Senator Burr. I hope you will do that with us because there
are areas of the country that Ryan White Care Act funding does
not find HIV patients, and I think that was really the nucleus
of why we created this, which was to make sure that the funding
was there to provide the services.
I certainly look forward to your time as Secretary and urge
the chair to move it as quickly as we can.
Thank the chair.
Governor Sebelius. Thank you.
The Chairman. Thank you very much.
Senator Sanders, we want to thank you. You have been here
the whole hearing this morning. It doesn't surprise any of us
that know of your dedication and commitment to this committee.
But in any event, thank you very, very much for your presence.
Statement of Senator Sanders
Senator Sanders. Thank you, Senator. And welcome back.
And Governor, we look forward to your speedy confirmation.
Let me make a brief statement and then ask you a few
questions because I think it is important to raise the issue of
the role of private insurance companies in our healthcare
system. I, just last week, introduced a single-payer national
healthcare program to be administered at the State level
because I happen to believe that the function of private health
insurance is not to provide quality, cost-effective healthcare
to individuals, but to make as much money as they possibly can
in a number of very questionable ways.
I think that at a time when approximately 30 percent of
every healthcare dollar spent through a private insurance
company ends up in administration, profiteering, advertising,
or whatever, that so long as we remain dependent on private
insurance companies, we are never going to have quality, cost-
effective healthcare for all Americans.
I suspect that position is a minority position here. But
let me ask you a question about an issue that a number of
people on both sides of the aisle have raised, and that is the
issue of primary healthcare. I know you wrote in your statement
of your concern about the lack of physicians, the lack of
nurses, the fact that it is true some 16 million Americans
today do not have a doctor of their own. They end up in the
emergency room. They end up in hospitals at a far greater cost.
When Barack Obama was a Senator, he supported a very
substantial increase in the number of community health centers
in America so that, in fact, we would have a community health
center in every underserved area in this country, supported a
very significant increase in the National Health Service Corps.
In fact, in the stimulus package, we doubled funding for
community health centers, tripled funding for the National
Health Service Corps.
Will you work with me and many members of this committee so
that we continue the effort to expand the National Health
Service Corps, help pay doctors' debts so we can get them out
into primary care, and move forward on community health
centers?
Governor Sebelius. Senator, absolutely, you have my
commitment that, if confirmed, I would love to work with you on
that initiative. First of all, I want to just thank you for
your leadership. Community health centers have been a passion
of yours and a mission of yours, and I think it is probably
largely due to your tenacious efforts that that is included as
a significant investment in the American Recovery Act.
Having said that, I see community health centers and the
National Health Service Corps as a key building block in health
reform. I think one of the challenges that we have is to make
sure that the essential components of what is in place right
now, whether it be the community health center program and the
service corps, who provides essential primary care, or the
expanded CHIP program or the services of Medicare and Medicaid,
that they are operating as effectively and efficiently as
possible for taxpayer dollars, but also getting the best health
outcomes possible as we look at the challenge of sort of
closing the gap.
So, as Secretary, I would absolutely love to work with you
on making sure that these are effective, efficient, and
expanded.
Senator Sanders. Thank you. As I am sure you are aware, our
chairman was the founder of that very extraordinary program.
One of the problems we are having, as we expand community
health centers, is this whole issue of how you designate an
underserved area. And it is not the best--we need some work on
that, and I would look forward to working with you to clarify
what constitutes an undesignated area because sometimes you
have real desperate need, but for bureaucratic reasons, they
are not designated. So there is work to be done there.
Let me ask you a question about prescription drugs. As you
may know, we pay the highest prices in the world for
prescription drugs. Many of our people simply can't afford
them. Canada, Europe charges substantially less for the same
drugs that we purchase here.
Are you supportive, will you work with us on the concept of
reimportation of prescription drugs?
Governor Sebelius. Senator, I am aware that Congress has
designated that the Secretary can, if the system is found to be
safe and secure, designate that reimportation from Canada is
acceptable.
I would suggest, at least at this point, that restoring the
FDA's competence and capabilities to its previously held gold
standard is really step one, that having--we have recently had
a situation with Heparin coming out of China. We have had
melamine, which, again, showed up in pet and animal food, not
in prescriptions. But there is some evidence that the current
challenges are not being well met.
But I certainly am one who thinks that we need to take a
look at the reimportation, make sure that there are avenues,
lots of avenues for Americans to access high-quality, lower
cost prescription drugs, and I look forward to having that
dialogue, if confirmed as Secretary.
Senator Sanders. Mr. Chairman, thank you very much.
The Chairman. Thank you very much.
Senator Roberts, thank you.
Senator Roberts. Mr. Chairman, thank you. And thank you for
your patience.
And Governor, thank you for your stamina. As Henry VIII
said to one of his wives, I won't keep you long.
[Laughter.]
We have had a good conversation, I would say to my chairman
and members of the committee who are still here and anyone in
the audience still here interested in healthcare. And the
Governor and I talked about something called comparative
effectiveness research. I think Dr. Coburn has already asked
you a question about that.
And your response was that CER, or comparative
effectiveness research--everything has to be an acronym here--
on best practices should produce the best possible research.
But I think the whole point is that I do not believe it will be
the best possible research. That is done at FDA over years of
time. Sometimes FDA comes under a lot of criticism because of
that.
The possibility could very well be in the push to control
cost and cost containment that has already been mentioned by
Senators Murkowski, Coburn, Burr, and others and members on the
other side of the aisle, it will be used to justify what I call
rationing healthcare, i.e., cost containment.
You and I both know the situation in Kansas very well with
83 critical access hospitals, very similar to the testimony
given or the great argument or rationale being expressed by
Senator Murkowski and the problem in Alaska.
Senator Burr mentioned the donut hole in regards to
Medicare Part D, and this is reflective of the problem because
I can remember talking to the president of the Kansas
Pharmacist Association in a very small town in Kansas, and the
provider of Medicare Part D in many of our small communities,
it isn't Medicare. You don't dial 1-800-MEDICARE. I mean, that
is sort of useless, to tell you the truth.
Then you have the Centers for Medicare and Medicaid
Services, or the renowned CMS--used to be HCFA--and I won't
tell you what our providers call CMS. It wouldn't be
appropriate. But all they are--they just sort of view them as
the Lizzie Borden of HHS.
This pharmacist was the provider and about the only
provider of Medicare Part D, and that is replicated in many
small communities. In that donut hole, we have 20 insurance
companies that will provide healthcare during the donut hole
period. But it is a different kind of a thing, and it is
expensive.
But in trying to address this to a patient who said, ``I
fell into the donut hole. What am I going to do?'' And he said,
``Well, for you, it should be this plan, and I could provide
you that plan. But I can't because I am not being reimbursed at
the cost. I only get 70 percent of the cost.''
That is why I say that maybe I am a contrarian here a
little bit. I am for healthcare reform. I don't know anybody
that is not for healthcare reform. But I worry about what lurks
under the banner of reform, and I want to see our current
healthcare delivery system at least stabilized to the degree
that we can at least continue what we have. And I don't see
that with doctors, hospitals, pharmacists, home healthcare
people, clinical labs, ambulance drivers. Over and over and
over again, the cost containment factor comes into play.
And I understand that we have to control Medicare spending,
but this is not the way to do it. And the thing that really
worries me about the comparative effectiveness research, we
just had in a hearing last week in the House where Director
Raynard S. Kington of the National Institutes for Health
testified his agency may use the money from the economic
stimulus law to fund grants for comparative effectiveness
research that includes comparison of the cost of the treatments
involved. Not care, but costs.
If we give that golden ring to CMS, Governor, I will tell
you that they will run with it, and we will continue to have
problems in rationing healthcare all throughout our healthcare
delivery system. Now I got on my CMS rant, and I told you that
when we had our talk, I wouldn't do that. I have. But could you
just give a couple words of assurance to us--I know Senator
Murkowski has really said this more effectively than I have.
I will repeat it again when we meet Thursday on the Finance
Committee. But could you just give me some assurance that you
know what the problem is at least currently with CMS and we can
at least take steps to prevent that and not make comparative
effectiveness research conclusionary research, and it has to
include clinical research as well as cost?
Governor Sebelius. Well, Senator, first of all, let me tell
you that I hope I don't have the same fate as one of Henry
VIII's former wives.
[Laughter.]
I appreciate you asking that question, and we did have this
discussion earlier. I think the fundamental difference is that
the current statutory authorization prevents CMS, prevents
Medicare from using comparative effectiveness research as a
cost decision- maker. It is prohibited by law. The Congress
made that a part of the statutory authorization.
So unless that law is changed----
Senator Roberts. Right.
Governor Sebelius [continuing]. And I can commit to you, if
I am confirmed as Secretary, I will make sure that the CMS
follows the law.
Senator Roberts. We have--pardon the interruption. But
there are several words in the budget that actually says that
CMS will have that authority.
Senator Baucus, others of us want to make sure that we put
language in there, and there is language that is proposed that
care will be considered just as much as cost containment. So I
think it is coming.
Governor Sebelius. Well----
Senator Roberts. It is just how it comes.
Governor Sebelius. I can't tell you that I am not concerned
about ultimately--not with comparative effectiveness research,
but ultimately reaching a point where in order to control
costs, there is some effort to ration healthcare.
I, frankly, as insurance commissioner where I served for 8
years, saw it on a regular basis by private insurers who often
made decisions overruling suggestions that doctors would make
for their patients that they weren't going to be covered. And a
lot of what we did in the Office of the Kansas Insurance
Department was go to bat on behalf of those patients to make
sure that the benefits that they had actually paid for were, in
fact, ones that were delivered.
I have some experience in fighting for the fact that
providers should make medical decisions. That is one of the
reasons that we have people who go to medical school and not
come up through an administrative agency in the Government or
through an insurance company or any other number of ways that
healthcare can get rationed.
I have worked in that system. I believe in that system. I
do, though, support the notion that we would do comprehensive
research on what are effective strategies to get the best
health outcomes for American people?
We know that protocol varies dramatically. Sometimes in one
area of the country, certainly across the country, that very
different protocols are used with very different results. And I
think the more providers can have access to that information
and certainly that consumers can have access to that
information, the more likely we are to have the best possible
health outcomes.
Senator Roberts. I am already over time, Mr. Chairman.
Thank you.
I will ask my least costly alternative question in
reference to this when we see each other at the Finance
Committee. Thank you so much, Governor.
The Chairman. Senator Casey.
Statement of Senator Casey
Senator Casey. Mr. Chairman, thank you very much. It is
great to see you here, and I want the chairman to know and I
want the Governor to know that when I left earlier, I was
juggling with Senator Harkin in the Agriculture Committee. And
he allowed me to be the chairman of the hearing for about 32
minutes.
[Laughter.]
I couldn't pass up that opportunity. My wife will never
believe it. So I want you to know that is why I was not here.
Governor, thank you very much, and I know the hour is late.
I want to try to get into two areas, if possible. One is on
early education and development, a topic and an area of public
policy that you not only know a lot about, but you have been
one of the leaders in the country on. You have brought a great
deal of achievement to your work as Governor in Kansas on both
of these, or I should say, the whole range of issues.
In terms of what we are going to do in the Federal budget,
in terms of Federal policy, I wanted to ask you about maybe
three examples of this. One would be childcare and the funding
levels. Two would be Head Start, and the third one would be
Early Head Start. You and I spoke of this when you were kind
enough to come by our office to talk about your confirmation.
One of the problems here is obviously not just a funding
challenge, but also the ability or the limitations we have in
enrolling people that are eligible. Childcare, a huge number--
as you know, a huge number of families are eligible but not
enrolled. In Early Head Start, I think the number is something
like 3 percent of those eligible in that important program are,
in fact, enrolled.
Can you just talk to us about the priority of those kinds
of programs and what we can do about funding levels in the near
term especially?
Governor Sebelius. Well, Senator, it has been a passion of
mine that we focus as many resources as possible at the
earliest possible age of children because we know that the
results pay off in terms of incredibly improved outcomes. I was
a working mother and knew personally with our two boys that
having high-quality childcare and then early education was a
critical component of my being able to go to work, of my
husband's being able to go work.
So I dealt with the situation as a parent. As 20-some years
ago when I was elected to the legislature, it became one of the
first focus areas because we had a pipeline of childcare
providers, which, frankly, were underpaid and undertrained. I
looked at ways to expand that. Put together a children and
families committee and put together a children's budget in
Kansas. And have continued those efforts.
One of the challenges which you have just addressed, which
I am very excited to have the opportunity to work on, is a
coordinated strategy with the childcare providers at the table,
with the leaders of Head Start and Early Head Start at the
table, along with those early educators who are often under the
umbrella of the Department of Education.
We did a similar strategy in Kansas. I think having a
collaborative and coordinated strategy, recognizing that
parents are going to make a lot of different choices for their
children. But about 85 percent of the mothers with children
under 5 are in the workforce. So most American children are in
a care situation outside of their homes, and having programs
particularly for the highest risk children, for the most at-
need children, which are not only safe and secure but introduce
early learning skills.
We know that brain development is most robust in the first
3 years. If we miss those 3 years, there will be some children
who will never catch up. So the more focus and attention--I was
very heartened to see that in the Recovery Act, there was a
significant expenditure for Early Head Start, for Head Start,
and for the childcare block grant, which is so critical to
provide those services.
I think the next challenge is to make sure that we are
using those strategies to rise to a level of quality, that we
have some quality standards introduced, that we have more
parent involvement. One of the, I think, best features of the
Head Start program from the outset was the involvement of
parents engaged in their own children's well being and their
own children's education. That has been a real hallmark of the
program.
But I think that an investment has been made, but we, as
you wisely say, need to continue that because we know that by
the time many children reach kindergarten, they are already so
far behind that they will never catch up with their peers. That
is not a good strategy for that individual child, but it is
really not a good strategy for this country.
Senator Casey. I know I am almost out of time. I will
submit another question for the record. I have an early
education bill that we spoke of and will look forward to
working with you on that.
I will submit a question for the record--we are at the 30-
second mark--on nurse home visitation. You and I spoke about
that. You are well aware of that program. In Pennsylvania, we
have about 40 counties that have that kind of a program where a
nurse is able to work with--more than work with--is able to
counsel and help a new mother so that that new mother can have
all the benefits of that kind of expertise.
It is a great, great pathway to making sure that a young
mother has a shot at having the kind of help that she needs in
addition to help from her own family, and I look forward to
talking to you more about that. But I will, in the interest of
time, submit it for the record.
Governor, thank you very much.
Governor Sebelius. Look forward to it. Thank you.
The Chairman. Senator, I'll be glad to recognize you and
thank you.
Senator Coburn. I thank you for the opportunity for a
second round of questions.
Governor, there is a Medicaid directive that states RU-486
is subject to the Hyde Amendment restrictions. Is there any
plans or can you give us assurance that that policy will be
unchanged?
Governor Sebelius. I am sorry, Senator. I didn't hear the
first part of your question.
Senator Coburn. There is a Medicaid directive on the books
by the previous administrative as to regards with RU-486 coming
under the Hyde Amendment. Can you give us an assurance that
that won't be changed, or are there plans to change that?
Governor Sebelius. Senator, as far as I know, there are no
plans. I certainly have had no discussions with anyone about
changing that policy. But again, I am not confirmed as
Secretary. I haven't had those discussions, and I promise to
continue to keep you informed.
Senator Coburn. All right. Thank you.
One of the other concerns you and I talked about was the
conscience protections, and the Administration has announced
plans to revise those and change those. I guess the question
that I would have is can you give us--and you may not be able
to do that at this time--but will you give us forewarning on
what those changes are going to be?
As a pro-life obstetrician, I feel I have a constitutional
right to have those protections as I practice medicine, and the
idea that the Administration may try or attempt to take away a
constitutional right that I have by saying what I must and must
not do as a practicing physician is rather offensive to me.
What I would like is the assurance that we will at least
get a heads-up on what that is going to be prior to a
unilateral announcement of that. Can you give us that
assurance?
Governor Sebelius. Senator, if confirmed, I would be glad
to not only give you that early warning of what the plans are,
but I can tell you right now that the President supports and I
support a clearly defined conscience clause for providers and
institutions. He always has. I always have. It has been in
place in Kansas the entire time I have been in elective office.
I know there was some concern about the regulation that was
proposed or implemented at the very end of the previous
Administration that it was overly broad and, frankly, overly
vague. So I don't think, from the discussions that I have had,
there is any intention of interfering with the underlying legal
basis that you have just suggested. And I will certainly be
glad to keep you informed.
Senator Coburn. Thank you.
I want to go back to cost for a minute. You oversee about
$800 billion worth of spending through Medicare and Medicaid
and SCHIP. A conservative estimate right now is that we have
upwards of $80 billion a year in both fraudulent payments and
improper payments in Medicare alone and $40 billion worth of
fraudulent payments and improper payments in Medicaid. That
comes to 20 percent of the program.
I am amazed, and I think most Americans should be amazed,
that we are not tackling this problem where there is $60
billion to $120 billion worth of waste and fraud, and instead
we are figuring on a tax system to allocate for 5 years $650
billion, $1.3 trillion is what if you extrapolate it out in
terms of end cost.
What do you plan to do to get at least the improper payment
rate down to what the average of the rest of the Federal
Government is, which is under about 3.4 percent? What are the
plans? Because that is where the gold is. That is where the
gold is, getting rid of the fraud and waste and improper
payments in Medicare and Medicaid.
Governor Sebelius. Well, Senator, as we discussed in your
office, I certainly think that significantly more aggressive
effort to go after fraud and abuse is well deserved.
I shared with you in my experience as insurance
commissioner, one of the things we did was put together a very
aggressive fraud unit in collaboration with the attorney
general's office. You have suggested a similar opportunity may
exist with the Federal Government in conjunction with the
attorney general's office.
But it is something I certainly take very seriously and
think you are absolutely right. First of all, the providers and
companies and patients who are fraudulently billing the
taxpayers not only need to be found and penalized, but those
dollars need to be shifted to provide health services to all
Americans.
So you absolutely have my commitment. I look forward to
getting some of your best ideas and seeing how fast we could
put them in place. You talked a lot about having preemptive
policies instead of what we are doing right now, which is after
the fact audits, of 10 years down the road. And I could not
agree more that having a few strike operations may be the most
effective way to send a signal that there is a new sheriff in
town, and I intend to take this very, very seriously.
Senator Coburn. If, in fact, we could recapture that money,
you wouldn't need the reserve fund in the budget. You would
have enough money for anything the President wants to do.
Governor Sebelius. Well, I think there is no question that
I would be enthusiastic about that, and I can guarantee you the
President would, too.
Senator Coburn. Of course, that is the problem the American
people have with us. We don't fix the problems we have. We just
create new programs that ignore those, and one of the things we
have to do on healthcare is that.
Mr. Chairman, I thank you for your indulgence. I am sorry
to drag on. I will have several questions for the record.
Governor, thank you for being here and being so attentive
to my questions.
Governor Sebelius. Thank you.
The Chairman. I would just say I think Senator Coburn
emphasized a very important point, and I would welcome the
opportunity to work with him, and we could share that with our
colleagues and try and see what we could work out on our
committee and on our sister committee, on the Finance
Committee. But we will focus on our committee on that.
I think this is extraordinarily important, and I think we
have come in touch with this issue time and time again and have
done far too little. And we welcome the opportunity to work
with him.
Let me just thank all of those who are here, still have
remained with us. I was especially interested in the work on
the cancer efforts. We have three major efforts on the cancer
prevention and research and treatment, and these are really the
heart of the whole effort on this.
I don't know whether you have any kind of comments you
would like to make about each of those areas. You could go on
for a long period of time on each of those. But is there any
one of these that you think that we ought to be giving any
special attention to now?
As I said, I certainly could, on any one of these, go on
for some period of time. And I don't know whether it is fair to
say one aspect of it is more worthy than others, but maybe you
could just comment about that concept and what, if anything,
you think that we ought to be moving ahead with?
Governor Sebelius. Well, Senator, I don't think there is,
Mr. Chairman, any question that cancer is an illness that has
touched every American. You are currently experiencing a battle
with the disease. But I don't think there is anybody who
probably is in this room who doesn't have a loved one or
someone close by who hasn't been involved in a similar
situation.
I am not as familiar as I probably should be with the
individual legislative initiatives. I do know that the
President has a commitment to dramatically increase cancer
research. He believes, as I do, that curing cancer in our
lifetime is a reality that we could achieve with the proper
focus as we look.
I have had some preliminary discussions with individuals
within the department as they look for new heads of both the
National Institutes of Health and the National Cancer
Institute, certainly leadership on the research and technology
end, but also on the service end.
I know, as Governor, we in Kansas have identified that
having a National Cancer Institute designation in conjunction
with the university, given the fact that there are not centers
in proximate areas, so our citizens can have access to cutting-
edge treatments is a priority I think not only in Kansas, but
across the country.
So I look forward, if confirmed, to working with you on
this critical issue.
The Chairman. Well, thank you very much.
You obviously have thought about this and are ready to act
on it, and we certainly welcome that.
At today's hearing, we have had the opportunity to examine
the challenges that our new Secretary will face, and they are
certainly large challenges. But we also have seen that our
nominee has the abilities, I believe, to be able to handle all
these challenges.
So I strongly support Governor Sebelius as the Secretary,
and I look forward to working with her very closely in the
months and years ahead to make a difference on the health for
all of the citizens of our country.
Thank you very much.
Governor Sebelius. Thank you, Senator. Thank you, Chairman.
[Additional material follows.]
ADDITIONAL MATERIAL
Response to Questions of Senators Kennedy, Harkin, Mikulski, Murray,
Reed, Brown, Casey, and Hagan by Kathleen Sebelius
QUESTIONS OF SENATOR KENNEDY
Early Childhood Education
Question 1. Historically early learning at the Federal level has
been exclusively under the jurisdiction of HHS. But at the State level,
early learning is often focused on State preschool, which is frequently
run by State education agencies. As Governor of Kansas you invested
significantly to ensure that children have access to high quality early
learning opportunities. As Secretary, how will HHS work with the
Department of Education in developing and implementing the
Administration's early childhood policies?
Answer 1. If confirmed as Secretary of HHS, I plan to work very
closely with Secretary Duncan to strengthen early learning programs at
HHS and Education. Secretary Duncan and I will also work closely to
support and implement the President's Early Learning Challenge Grants
proposal, to encourage States to raise the quality of their early
learning programs, ensure a seamless delivery of services, and ensure
that children are prepared for success when they reach kindergarten.
As a Governor, I learned that collaboration between child care,
Head Start, preschool, and other early childhood programs at education
agencies is essential to achieving the objectives we are seeking for
young children and their families. With that in mind, I intend to do
everything I can to improve collaboration at the Federal level on early
childhood education programs.
Question 2. What role do you see Head Start and Early Head Start
programs playing in President Obama's Early Learning Challenge Grants
proposal and comprehensive Zero-to-Five plan?
Answer 2. I believe that Head Start and Early Head Start are
critical elements of our Nation's early childhood education system. The
American Recovery and Reinvestment Act provided a needed expansion of
these essential programs, including an additional $1 billion for Head
Start and $1.1 billion for Early Head Start. These investments will
support, reinforce, and extend the impact of the Administration's
exciting new Early Learning Challenge grants and the President's early
education agenda. If confirmed as Secretary of HHS, I intend to work
closely with Secretary Duncan to ensure effective coordination of early
learning programs within both departments.
Head Start & Early Head Start
Question 3. What steps will you take to encourage States to fully
leverage and promote the contribution that Head Start programs and
services make to children's school readiness and family engagement in
order to promote early childhood system building at a State level?
Answer 3. I believe it is critical to promote and continue
collaborations between State governments and the Head Start programs,
and, if confirmed, I look forward to working with our State partners
and members of the Head Start community to build upon the successes
that have already been achieved in many States. Among the critical
areas on which collaboration should focus are school readiness and
family and parent engagement.
Question 4. What are your plans to ensure that Head Start programs
can accomplish the goals and the mandates included in the last Head
Start reauthorization.
Answer 4. I applaud Congress for enacting a landmark
reauthorization of the Head Start Act, and I am very excited about the
prospect of working to implement key elements of this vital
legislation. In particular, I am interested in leveraging all the
assets and tools of HHS to find ways to improve results for children
and families served by Head Start. If confirmed, I will carefully
review the status of needed regulations and work to promulgate them as
expeditiously as possible. Moreover, I intend to work with Head Start
programs to meet the requirements and accountability measures set forth
in the Improving Head Start for School Readiness Act.
Question 5. The Head Start Act requires States to create advisory
councils to better plan and coordinate the delivery of education and
health services to young children, including better connecting Head
Start, child care, pre-k, and the K-12 systems. As Governor of Kansas,
you signed legislation creating the Kansas Early Learning Coordinating
Council to help achieve those goals. Greater Federal resources and
leadership are needed to support this vital State work. What role do
you see the State Advisory Councils playing to improve the delivery of
early childhood services, and how would your Department support and
expand their work?
Answer 5. As you indicate, as Governor of Kansas, I established an
Early Learning Council to coordinate funding streams and link programs
serving young children and their families. I found this to be a very
effective strategy, and I believe the State Advisory Councils
established in the Head Start Act, and similar structures, are valuable
tools that can help States find creative and effective mechanisms to
coordinate and improve early childhood programs funded by multiple
sources. If confirmed as Secretary of HHS, I would commit to supporting
these State Councils in their planning, coordination, and
implementation activities.
Child Care
Question 6. What are your plans to improve the quality and
availability of child care?
Answer 6. As a working mother of two sons, I remember the challenge
of balancing work and child care. Research and common sense tell us
that high-quality early childhood education programs make a greater
impact on children, get young children ready to learn and thrive in
school, and provide powerful returns for our economy and our ability to
compete in the 21st century.
As Governor of Kansas, I worked to create a statewide early-
learning council to help coordinate and improve early childhood
programs across our State. I am proud of what we did to make child care
available to more working parents, but I take even greater pride in our
comprehensive strategies to improve quality through investments in
capable staff, challenging curricula, and effective programming.
If confirmed as Secretary, I look forward to building upon the
tremendous investments already made, through the Recovery Act, in the
Child Care and Development Block Grant ($2 billion), Early Head Start
($1.1 billion), and Head Start ($1 billion).
Question 7. While early care and education must be a priority
within the Administration on Children and Families (ACF), recent
structural changes seem to have lowered the visibility and priority of
child care within ACF. As Secretary, would you re-establish the Child
Care Bureau as a separate entity and align it in stature with the
Office of Head Start in ACF?
Answer 7. Promoting high-quality child care, and ensuring its
availability to more children, is a top priority of this
Administration. If confirmed as Secretary of HHS, I will carefully
review HHS's organizational structure to ensure that it is designed to
meet these goals and deliver results that support priorities of our
children and families. Child care and early childhood programs are
crucial priorities within HHS.
QUESTIONS OF SENATOR HARKIN
Question 1. Gov. Sebelius, as you will recall, the Dietary
Supplement Health & Education Act of 1994 provides the FDA with the
authority to oversee and regulate the supplement industry. In December
2006, Congress passed the ``Dietary Supplement and Nonprescription Drug
Consumer Protection Act'' which the President signed into law and which
required for the mandatory reporting of serious adverse event reporting
for supplements.
Do you agree with me, and with past Secretaries of HHS and FDA
Commissioners, that those laws are still adequate, not in need of
amending, and give the FDA sufficient authority to regulate the
industry and protect the public/consumers?
Answer 1. Millions of Americans rely upon dietary supplements to
supplement their nutritional intake, believing such products can help
bolster their immune systems, protect them from diseases, and slow down
the aging process. I know that clinicians and advocates believe that
these products should be studied to ensure they are effective and safe.
When it comes to these products, the FDA has a responsibility--just as
it does with food, drugs, and devices--to ensure that the marketing
claims are truthful, and, more importantly, that Americans cannot be
harmed. Yet, the FDA must strike an appropriate balance between
regulating these products and maintaining access for consumers. If I am
confirmed as Secretary and determine that additional authorities are
needed, I will work with you to ensure that consumer access is not
compromised.
Question 2. How will you revitalize the Office of Civil Rights at
HHS? In particular, how will you ensure that the Office provides
sufficient oversight over the HIPAA Privacy Rule, both in terms of
enforcement of current rules (which was lax under the Bush
administration) as well as ensuring that the regulations keep up with
developments in health IT?
Answer 2. Ensuring the privacy and security of patients' personal
health information is of paramount concern. Existing policy (the Health
Insurance Portability and Accountability Act, or HIPAA) provides a
basic level of protection, but we need to do more. The privacy and
security rules must be revised to keep up with ongoing developments in
health information technology (HIT), and must take into account the
constantly-evolving nature of HIT.
Besides being reviewed and updated, the privacy rules must be
enforced. As you know, a recent HHS Office of the Inspector General
report found that the Department has done little to ensure that
entities covered by HIPAA use sufficient measures to stop privacy
breaches before they occur. As Secretary, I will work to ensure that
the Office of Civil Rights has the necessary leadership and resources
to protect effectively the rights of individuals to preserve the
confidentiality of their medical information.
Question 3. Much concern from consumers has been articulated about
food safety and how the new Administration is going to improve the food
safety system. Recent outbreaks of food-borne illness have had a
negative impact on consumer confidence in our food supply. Several
contamination events have harmed numerous people and animals and have
led to a dangerous mistrust of FDA's ability to keep our food supply
safe.
What lessons do you think HHS has learned from these incidents and
what actions could be taken in the future to ensure a safer food
supply?
Answer 3. Like all Americans, I have been shocked by the recent
outbreaks caused by contaminated food--including spinach, tomatoes, and
now peanut butter. It is staggering that problems at just one facility
can contaminate hundreds of products, sicken thousands of consumers
across the country, and even take the lives of our friends and
neighbors. We must do better.
Among other things, we must shift our focus away from simply
working to catch contamination of the food supply after it has already
happened and towards preventing contamination from occurring in the
first place. Doing so may require a new regulatory approach and new
authorities, and it will certainly require a new shared responsibility
with industry and State and local officials. If confirmed, I look
forward to restoring trust in FDA as a world-class public health
agency, and to working with Congress to ensure that the food we eat and
the medicines we take are safe.
Question 4. President Obama has called for a Food Safety Working
Group to coordinate food safety activities across the agencies. How
will you, in your capacity as Secretary of Health and Human Services,
coordinate between FDA, USDA's Food Safety and Inspection Service, and
the Centers for Disease Control and Prevention to mitigate the growing
number of food-borne illness outbreaks in the United States?
Answer 4. As Secretary, I will ensure that all parts of the
Department, from the FDA to CDC to NIH, are working together to
safeguard our food supply. I will also work to ensure effective inter-
departmental coordination between HHS, USDA, and other key agencies.
The President has acted to strengthen this coordination through his
White House initiative that established the Food Safety Working Group.
Moreover, the President's 2010 budget includes new funding for the food
safety center at FDA. This investment will help the agency work with
farmers, the food industry, consumer organizations, and the public to
develop a strong public health approach to food safety.&
Question 5. Various groups have put forth ideas on how to change
the government's food safety systems. Currently these systems are
fractured across many agencies and have differing levels of
effectiveness and authorities. Food safety must become a high priority
within your Department, the Department of Agriculture, and within the
Administration to ensure the safety of food consumed by the public.
How would you improve the structure of FDA's leadership to place a
greater emphasis on food safety? Would it be effective to establish a
new high-level position that would focus solely on improving and
advocating for food safety programs at FDA?
Answer 5. As I stated in a previous answer, I believe our immediate
goals must be to ensure that we have a modern regulatory system in
place, to increase our focus on prevention, and to reassess and improve
our existing legal authorities. I also believe we must ensure effective
coordination between all our food safety agencies, both within HHS and
across other Federal departments. With the right leadership and the
right priorities, I believe we can accomplish these goals.
Question 6. What are your thoughts on how a greater emphasis on
preventive services can be incorporated into health reform? Do you
believe that a reformed health system should require coverage for
preventive services recommended by the U.S. Preventive Services Task
Force in public and private plans?
Answer 6. Wellness and prevention are urgent priorities. This
century's epidemic is chronic disease: over 70 percent of costs and
deaths result from it. Yet, we spend only 1 to 3 percent of our $2.6
trillion health system on prevention.
President Obama has committed to expanding clinical and community-
based prevention to shift our health care system from an ``acute care''
system to one that prioritizes health promotion and disease prevention
activities. As part of his health reform agenda, the President
established the coverage of evidence-based prevention services as an
objective of a reformed health system. If confirmed, I will work with
the President and Congress to make a greater focus on prevention a key
cornerstone of health reform.
Question 7. Mental health and substance abuse are key as we are
discussing reducing the costs of health care and addressing prevention
and public health. It is integral that there is coordination amongst
SAMHSA, CDCP and NIH amongst the other agencies. As you know, mental
health and substance abuse is interconnected with physical health. For
example, it has long been recognized that patients who suffer from
depression are more likely to have heart attacks or other cardiac
events.
How would you work with other agencies to develop and implement a
strategic approach to the promotion of mental, emotional, and
behavioral health and the prevention of MEB disorders and related
problem behaviors in young people and to ensure alignment of resources,
programs, and initiatives with this strategic approach and for
encouraging their State and local counterparts to do the same?
Answer 7. I commend the Congress for passing mental health parity
legislation last year. I believe that private and public insurance
plans should include coverage of all essential medical services,
including mental health care, and that serious mental illnesses must be
covered on the same terms and conditions as are applicable to physical
illnesses and diseases.
QUESTIONS OF SENATOR MIKULSKI
Question 1. Governor Sebelius, in your role as Secretary of Health
and Human Services, you also will have responsibility in combating the
threat of bioterrorism. Recently, former Senators Bob Graham and Jim
Talent released their World at Risk Report.
Do you agree that a bioterrorist event from a weapon such as
anthrax remains at or near the top of our Nation's most serious
threats?
Answer 1. Yes.
Question 2. Assuming you do agree, what efforts does HHS plan to
pursue to help DHS and the Administration address and communicate that
threat to Congress and State and local governmental authorities?
Answer 2. HHS has supported DHS's risk and net-assessment efforts
and will assist in whatever ways are necessary to communicate with the
Congress, State, and local authorities regarding those efforts and
other appropriate medical and public health solutions that are needed
to counter the threat. Additionally, the Office of the Assistant
Secretary for Preparedness and Response (ASPR) at HHS has sponsored
stakeholder workshops and invited presentations at emergency
preparedness and other scientific meetings to discuss the anthrax
threat and countermeasure activities.
Question 3. Specifically with regard to the World at Risk Report,
did HHS collaborate with the Commission on the document?
Answer 3. Yes, the Principal Deputy Assistant Secretary for ASPR,
Dr. Gerald Parker, briefed the Commission on HHS programs and views.
Jonathan Tucker, a Commission representative, conducted interviews
within the Department.
Question 4. Alternatively, are there any points, conclusions,
warnings, etc. contained in the Report that HHS disagrees with or takes
issue?
Answer 4. In general, HHS agreed with the strategic conclusions of
the report.
Question 5. Does HHS plan to pursue any new or heightened
initiatives based on the Commission's findings?
Answer 5. In August 2008, President Bush submitted a supplemental
budget request totaling $905 million to initiate efforts for medical
countermeasure advanced development and dispensing in the United
States, focused primarily on anthrax. To date, no appropriation has
been provided based upon this request.
Within the existing budget, HHS will continue its efforts to
develop, stockpile, and build manufacturing infrastructure for new
anthrax vaccines, antitoxins, and antibiotics, including antibiotic
MedKits for responder populations. These efforts will focus on the
development of next generation broad-spectrum antibiotics to treat
illness against enhanced anthrax agents that are antibiotic-drug
resistant, and on working with the Department of Defense to establish
new public-private centers of excellence for countermeasure
development/manufacturing in the U.S. against biological threats,
including anthrax.
Question 6. In that HHS is responsible for the development,
acquisition, and delivery of appropriate countermeasures, how closely
has HHS been involved in the Federal Government's overall threat
assessment dialogue?
Answer 6. HHS has provided scientific input to both the DHS risk
and net-assessment processes. Threat and risk information then informs
the Department's research, development, and acquisition priorities.
Question 7. Specifically, is there a coordinated interagency
process to prioritize HHS's development and acquisition efforts based
on current USG threat information?
Answer 7. The Public Health Emergency Medical Countermeasure
Enterprise, established under Pandemic and All-Hazards Preparedness Act
in December 2006, provides the framework across the U.S. Government to
coordinate research, development, stockpiling, and utilization of
medical countermeasures for chemical, biological, radiological, and
nuclear threats. The Enterprise Governance Board, comprised of agency
heads primarily from Departments of Health and Human Services, Defense,
Homeland Security and Veterans Affairs, provides strategic guidance and
policy setting for these activities. Senior advisors in these agencies
constitute the Enterprise Executive Committee, which provides tactical
implementation of these policies and interacts with and directs
interagency project teams that deliberate and study different aspects
of these countermeasure activities.
In addition to these questions, I also have some regarding the
funding of biodefense medical countermeasures, the development and
acquisition of new medical countermeasures, and the coordination
between HHS and the Department of Defense around the Strategic National
Stockpile. I look forward to your responses and working with you on
these very important issues surrounding the Nation's preparedness
against the threat of bioterrorism.
QUESTIONS OF SENATOR MURRAY
Trauma Care
Question 1. Our Nation's trauma centers rely upon up to 16 highly
trained subspecialties to be available 24/7 to literally put people
back together again.&
For example, Harborview in Seattle is the only Level 1 trauma
center in Washington State, and is responsible for serving a four-State
region (Washington, Alaska, Montana and Idaho).
It is absolutely essential that critically injured patients have
access to life-saving trauma care services where and when they need
them.&
As we are looking at reforming the health care delivery system to
re-align incentives such that reimbursement better flows with
appropriate patient care--such as through medical homes, better
preventive care and disease management--how do we also ensure that the
changes in reimbursement do not inadvertently and negatively impact
trauma care services?&
Answer 1. Trauma centers are a critical part of our health care
infrastructure, and serve all Americans, regardless of ability to pay.
One of the main reasons that emergency departments and trauma centers
are struggling has to do with uninsurance and uncompensated care. As we
move toward a system in which more Americans are covered, much of the
financial pressure on emergency departments and trauma services will be
relieved. That said, it will be critical to ensure that the financial
incentives are aligned appropriately to assure that trauma care remains
available, without creating incentives to use emergency services in
non-emergencies. This will create a win-win both for primary care and
for trauma care.
Prevention and Outreach
Question 2. There is no doubt that reform is needed to ensure
affordable access to quality health care for all Americans, but we must
also derive more value from our health care dollars. We need to not
just help people when they are sick, but actively focus on keeping
people healthy.
Senator Harkin has been a leader on prevention, and I agree with
him--we need to get health care costs under control and that's not
going to happen unless we place a major new emphasis on disease
prevention and wellness.
One of my concerns regarding prevention and wellness programs is
accessibility. There's not much use having prevention or wellness
services if no one knows about them or how to access them.
There are some issues now with certain preventive services that are
available to the uninsured or underinsured but DOCS don't even know
about them, so they don't know to offer them to their patients.
Further, while we have worked to expand prevention services under
Medicare, the use of these services are vastly under-utilized. For
example, a 2006 study found that only 36 percent of women covered by
Medicare were getting a yearly pap-smear.
These services will only net gain in cost savings and better health
outcomes if they are utilized--what will you do as Secretary to
increase promoting prevention and wellness services?
Answer 2. The Department of Health and Human Services (HHS) has a
critically important role in promoting prevention and wellness services
to the American people. Specifically, HHS supports research, education,
and awareness, as well as direct services related to prevention across
the various agencies and offices.
If confirmed as Secretary, I will take a number of steps to better
promote prevention. Such steps include, but are not limited to,
bringing in new leadership with expertise and experience in prevention,
integrating and coordinating prevention efforts both within the
department but also governmentwide, working to expand access to
preventive services through existing public programs as well as within
a health reform initiative, and focusing on strengthening the public
health workforce to assist States and localities implement prevention
programs.
Emergency Preparedness Act
Question 3a. As you may know, the Fred Hutchinson Cancer Research
Center is a non-profit research institution based in Seattle, WA and is
currently taking a leading role in an NIH-funded and directed global
HIV/AIDS vaccine clinical trial. The program, entitled the HIV Vaccine
Trials Network, is an international collaboration of scientists and
institutions working to accelerate the search for an HIV vaccine. The
Hutch is coordinating the trial and research activities of more than
two dozen research institutions, at the direction of NIAID. This effort
is one of the few bright spots in our efforts to fight AIDS globally,
and is even more necessary, given the recent report indicating that
HIV/AIDS has reached ``severe epidemic'' levels right here in our
Nation's capital. However, these trials--and the entire work of the
Network--may be jeopardized due to concerns about risks and liability
exposure associated with potential litigation about the conduct of
clinical trials necessary to advance the research effort.
As Secretary, would you consider using existing statutory
authority, specifically, the Public Readiness and Emergency
Preparedness Act, to provide the Hutch liability protections to ensure
that these trials continue and an effective vaccine is ultimately
discovered and administered to those in need?
Answer 3a. This question raises a number of important issues and
illustrates the complexity inherent in new vaccine discovery.
Question 3b. Another potential solution would be to make these
institutions employees of the Federal Government for purposes of
liability protection under the Federal Tort Claims Act. Would you
support legislation that would extend the protections of the FTCA to
the Hutch, since it is carrying out its coordinating function on behalf
of HHS?
Answer 3b. The issue of further extending government liability
protections to a private entity such as a Federal grantee during the
clinical trial phase of vaccine development deserves careful
consideration. The critically important activities undertaken by
Federal grantees are not currently considered direct action by the
Federal Government, and we must take care to ensure an appropriate
balance of Government responsibility and control in supporting their
work. A number of options have been proposed and discussed in detail at
the National Institutes of Health, including NIH assistance in the
purchase of liability insurance. If the concerns of NIH grantees about
potential liability exposure are a threat to the important work of
vaccine discovery and development, I will closely examine all options
available to me to ensure that these trials move forward.
HIV Travel Ban
Question 4. Last summer, as part of a law reauthorizing the PEPFAR
program, the Congress removed HIV infection as a statutory grounds for
ineligibility for a visa or for admission to the United States.&
Is HIV still on the HHS list of ``communicable diseases of public
health significance'' which prevents entry into the United States?
If confirmed as Secretary of HHS, what steps would you take to
implement the changes to the HIV travel ban included in the PEPFAR
reauthorization?
Answer 4. HIV is still on the list of ``communicable diseases of
public health significance,'' which prevents entry of HIV-infected
individuals into the United States. However, HHS has already begun work
to implement this change and, as Secretary, I would do whatever
necessary to expedite this process.
Medicare Advantage
Question 5. The Washington State health care system has long been
known for its culture of wellness, prevention, and collaboration to
effectively coordinate health care for patients. The Dartmouth Atlas
project researchers have shown that this way of providing health care
keeps costs low, while the quality of our health care is high. What is
happening in Washington is what we are trying to make happen for the
rest of the country.
But decisions we make this year could jeopardize the positive parts
of health care in our State, and exacerbate the problems we do have,
such as severe primary care shortages in Medicare. For example,
proposals to bring Medicare Advantage rates--already the lowest in the
country--down to the unsustainably low FFS rates in Washington, would
mean taking over $300 million in Federal funding out of a health care
system that is already paid some of the lowest rates in the country.
That change would underscore the existing system that rewards volume,
not value, where there is great disparity across the country, and that
has led to my State's primary care shortage.
How can we work together to protect the valuable Medicare
coverage--through both coordinated care Medicare Advantage plans and
independent community docs, that seniors in my State receive?
Answer 5. I agree that Washington State's health care system is a
leading model for how we should transform the entire health care
system. It consistently produces high-quality outcomes while managing
costs. The entire U.S. health care system should follow the State's
lead to reward prevention, primary care, and care coordination. The
Medicare Advantage program can play a large role in promoting these
goals. I share your deep concern regarding the growing shortage of
primary care physicians and other health professionals, and I believe
we should examine Medicare's payment system in its entirety to ensure
that our Nation promotes and rewards primary care.
I also share the President's view that we must reform the way
Medicare pays Medicare Advantage plans, and I am concerned about the
high incidence of overpayment to these plans. But we must also
carefully consider any changes to the program to ensure that our
reforms reflect local health care dynamics and practices of care.
Toward that end, the President's budget includes a proposal to promote
greater competitive bidding for Medicare Advantage. I look forward to
working with you and the entire Congress to reform payments to Medicare
Advantage plans while also promoting broader health reform goals.
Washington State as an Example
Question 6. Just yesterday I had the opportunity to talk with
Washington's Governor about the success we have seen in our State's
health care system, as well as about the economic and budget hurdles
that have led the State to significantly cut our State-funded Basic
Health Plan that provides coverage to many low-income citizens, in
order to help fill the deficit. We believe we can help the country
solve some of the national health care problems by providing a model
for how care can be delivered in a low-cost, high-quality way, and I
would like to invite you to come visit Washington and see in-person the
kind of innovations and organizations that make our system work. But we
also need Federal assistance to ensure that the people currently
covered by the Basic Health Plan will have someplace to go for their
health care as the State is forced to cut back.
How can Washington State serve as a model, how can we help you as
you work toward developing new payment systems that reward value, not
volume, and new coverage models that do not depend as heavily on the
State budget process?
Answer 6. As a Governor, I consistently learned from other States'
examples, and I will continue to look to the States if I am confirmed
as Secretary. Washington State's Health Care Authority has been a model
for improving affordability, quality, and access through programs such
as Washington Wellness, Health Technology Assessment, and Community
Health Services. I will work with States to build on and support their
success. Moreover, the Administration is committed to tackling the
system-wide cost drivers that are crushing our families, businesses,
and State governments. As the President has said, health reform cannot
wait, and I fully agree.
Coordination of Early-Childhood Learning Programs
Question 7. Historically, early learning at the Federal level has
been exclusively under the jurisdiction of HHS. At the State level,
early learning is often focused on State preschool, which is frequently
run by State education agencies, such as Washington State's Department
of Early Learning. States like Washington are working hard to connect
Head Start, child care, pre-kindergarten, and K-12 systems to create
collaboration among education agencies and human services agencies to
improve services to families.
Right now many States are struggling to make these important
connections. President Obama has identified these collaborations as a
priority at the Federal level and has proposed creating early-learning
challenge grants to States through the Department of Education, which
could help encourage States to develop plans for the delivery of
coordinated early learning services.&
How can the Department of Health and Human Services work with other
agencies, particularly the Department of Education, to improve the
coordination and delivery of services in a way that best serves young
children in my State and across the Nation?
Answer 7. As a Governor, one of my highest priorities was children,
and there is no better public investment than providing support for
early childhood education and development. President Obama has
demonstrated his support through provisions in the Recovery Act that
increase funding for Early Head Start by $1.1 billion, Head Start by $1
billion, and Child Care Development Block Grant by $2 billion, as well
as his unprecedented commitment to key early learning programs at the
Department of Education. The President's budget calls upon States to
raise the bar in their early childhood programs, and work to ensure
that children are supported in their learning through a seamless system
of early care and education.
As I approach early childhood issues, I am anxious to leverage all
resources within the Department of Health and Human Services and better
coordinate and promote the education and development of young children,
while supporting their families. I will work to ensure coordination
between all the appropriate departments, including the Department of
Education, and our State partners to make sure we are providing the
best possible start for our Nation's children.
Home Visiting Programs
Question 8. Research tells us that the first months and years of a
child's life are critical in laying the foundation for later success in
school and beyond. Early childhood home visitation programs have been
shown to decrease child abuse and neglect, while increasing school
readiness and early identification of developmental and health delays,
including potential mental health concerns. Several effective home
visiting programs have been identified, including those providing
services delivered by nurses, social workers, child development
specialists, or other well-trained and experienced staff.
If confirmed as Secretary of HHS, how would you further a seamless
home visiting program that includes health, well-being, and school-
readiness components for children from birth through kindergarten?
Answer 8. I share your belief in the critical importance of the
first years of life, and we must do more to give our children the best
start possible. As Governor of Kansas, I also helped design and
implement an effective home visitation program. As you know, the
President's FY 2010 budget blueprint calls for creating a visitation
program that makes funds available to States to provide home visits by
trained nurses to first-time low-income mothers and mothers-to-be. If
confirmed as HHS Secretary, I look forward to working with you and
other Members of Congress to design, enact, and implement an effective
home visitation that will make a measurable difference in the lives of
children.
QUESTIONS OF SENATOR REED
Question 1. The President's budget makes a strong commitment to
funding the Low-Income Home Energy Assistance Program (LIHEAP),
requesting $3.2 billion, but as we know, the economic downturn is
increasing the importance of LIHEAP in the lives of low-income
families. Indeed, this was in part why Congress provided a total of
$5.1 billion in regular and emergency funding for the program in fiscal
year 2009. Recognizing the need, will you work with the Congress to
support greater resources for this program in the fiscal year 2010
budget process?
Answer 1. I share the President's strong commitment to LIHEAP, and
we both believe this program has been effective in helping low-income
families meet their home heating and cooling expenses. The need for
LIHEAP is never greater than when unexpected energy price increases put
already vulnerable low-income families at even greater risk--a
situation that occurred last year when the price of oil skyrocketed. To
meet this very real problem, the President's FY 2010 budget calls for
creating a new trigger mechanism to provide automatic increases in
energy assistance whenever there is a spike in energy costs. If
confirmed as Secretary, I look forward to working with you and other
Members of Congress to craft a reliable, efficient trigger to meet the
heating and cooling needs of low-income families.&
QUESTIONS OF SENATOR BROWN
NIH
Question 1. Important medical research being conducted at the NIH
represents our greatest promise at curing disease, improving health,
and saving lives. However, NIH currently dedicates only about 5 percent
of its annual extramural research budget to pediatric research.
If our investment in pediatric research is not increased,
discoveries of new treatments and therapies for some of the most
devastating childhood diseases and conditions will be hindered, and the
next generation of pediatric researchers will be discouraged from
entering the field.
As HHS Secretary, how will you alter NIH's research priorities to
give pediatric studies the prominence they deserve?
Answer 1. The NIH considers pediatric research a major commitment.
Twenty-two of the twenty-seven Institutes and Centers fund pediatric
research. For fiscal year 2008, the NIH created the Research,
Condition, and Disease Categorization Process (RCDC), a computerized
process the NIH uses at the end of each fiscal year to sort and report
the amount it funded in each of 215 historically reported categories of
diseases, conditions, or research areas. Using the RCDC method,
pediatric research constituted 9 percent of the total NIH budget in
fiscal year 2007, and 9.4 percent in fiscal year 2008.
NIH will use economic stimulus funds to expand extramural pediatric
research opportunities. The new Clinical and Translational Science
Awards (CTSAs) specifically encourage pediatric research, and the
pediatric community has responded vigorously with proposed activities
under this program. These activities are additionally augmented by
funds from the Best Pharmaceuticals for Children program. The CTSA
program will continue to grow and encourage pediatric research,
including the development of pediatric drugs and devices. Additionally,
NIH is increasing its efforts to train a new generation of pediatric
scientists. If confirmed as Secretary, I look forward to meeting with
leaders in pediatric research at the NIH to further address these
issues. &
Drug Discount Program
Question 2. I would like to bring to your attention a non-
controversial final notice that got stalled in OMB in the last months
of the Bush administration. It would implement children's hospitals
eligibility for the 340B drug discount program. Congress enacted a
provision providing for this eligibility in the DRA.&
It has been more than 3 years since the statutory effective date
and 1\1/2\ years since the proposed notice was published. Does the
Administration have plans to publish this notice in order to allow
children's hospitals the opportunity to apply and participate in 340B
by the next quarter of this year?
Answer 2. Expanding access to affordable drugs is a top priority
for the Administration. If I am confirmed as Secretary, I will examine
every option to increase drug affordability. Certainly, the 340B drug
discount program, which has been proposed by many providers and
advocates, is one such option. Given the program's effectiveness,
expanding eligibility merits close scrutiny for short-term action.
Antibiotic Resistance
Question 3. Antibiotic resistance is quickly turning previously
treatable conditions into deadly ones. Staph infections, for one, are
becoming more prevalent and more life-threatening. According to a
recent study, more than 94,000 invasive Methicillin-resistant
Staphylococcus aureus (MRSA) infections occurred in the United States
in 2005 and more than 18,500 of these infections resulted in death.
Worldwide, tuberculosis is facing the same challenge.
Senator Hatch and I have called for a new Office of Antimicrobial
Resistance in the Department of Health and Human Services. What are
your thoughts on creating a new office, within HHS, to deal with
antimicrobial resistance issues?
Answer 3. Antimicrobial resistance remains a major public health
challenge and must receive priority focus in this Administration. HHS
has taken steps to address this challenge, although it is clear that
more work remains to be done. If confirmed as Secretary, I will look at
every option to better coordinate and integrate activities across the
Department, and a new Office would certainly merit such consideration.
Dental Care
Question 4. Though often overlooked in health policy discussions,
access to dental care is of the utmost importance. Dental problems
inhibit an individual's ability to work and a child's ability to excel
in school.
Last Congress, I introduced the Deamonte Driver Dental Care Access
Improvement Act, named after the Maryland boy who died as a result of
an untreated tooth abscess. The bill would expand the dental care that
community health centers provide for low-income Americans, establish a
pilot program for new allied dental health professionals, and invest in
preventative oral health.
As HHS Secretary, how will you focus the Department's attention on
dental care problems?
Answer 4. Dental care is an important part of prevention and
wellness. Prevention has been a focus of the Administration--the
Recovery Act included a historic investment in proven interventions,
which will be a cornerstone of comprehensive health reform. A focus on
dental care and other key components of prevention will lead to a
healthier, more productive population, and save health care costs in
the long run.
Food Safety
Question 5. Late last year, the CDC identified another outbreak of
salmonella infections across the country. The CDC has reported that 550
people in 43 States and Canada have been infected by this outbreak. The
Ohio Department of Health has reported that 100 people in my State have
been affected by this outbreak.
Ohio--and the country as a whole--has been overwhelmed in recent
years by recall after recall. Last spring, a dozen Ohioans--and 1,400
Americans--were made ill by contaminated peppers. It took the CDC and
the FDA 3 months--and one false accusation of the domestic tomato
industry--to determine that these peppers originated in Mexico.
How do you envision reforming FDA so that it can once again fulfill
its mission to keep Americans safe? Do you believe that the United
States should have a better traceability system so that we can better
track food outbreaks? Do you believe that FDA should have the ability
to recall foods that the Agency believes are harmful to our citizens?
Answer 5. There is a need within FDA and our other food safety
agencies for increased integration and coordination to ensure an
effective, modernized approach to food safety. If confirmed as
Secretary, I will work with FDA, Congress, and my counterparts in the
Administration to determine the most appropriate organizational
structure to achieve this goal. Effective product tracing should be a
part of a modernized approach. It would allow FDA to more quickly
identify the source of a contaminated food and where it has been
shipped. In addition, providing FDA with mandatory recall authority
would give the agency an important tool to remove unsafe foods from
warehouses and store shelves before they get to consumers.
Other
Question 6. As has been widely reported, Dr. Peter Pronovost from
Johns Hopkins University has devised a 5-point checklist to prevent
catheter line infections in hospitals. This simple tool saved 1,500
lives and $100 million over an 18-month period in Michigan.
I have been working with the Ohio Hospital Association to bring
this life-saving mechanism to my State and am pleased to report that
the Agency for Healthcare Research and Quality (AHRQ) recently
announced that 10 States, including Ohio, have been selected to
participate in a program to test methods of reducing central-line
associated blood stream infections in hospitals.
How do we ensure that common-sense quality improvements--like Dr.
Pronovost's checklist--are quickly adopted nationwide? Is this a job
for a Federal Health Board, for AHRQ, or for HHS more broadly?
Answer 6. Empowering providers and patients with the information to
make informed health care decisions is a key tenet of a high-quality
health care system. Agencies such as AHRQ must work hand-in-hand with
provider and patient organizations to disseminate useful research and
innovations to inform practice. A collaborative approach can ensure
that Americans receive up-to-date, high-quality care.
QUESTIONS OF SENATOR CASEY
Question 1. Governor Sebelius, I was very pleased to see that the
President included a new budget line for nurse home visitation in his
budget outline. The Nurse-Family Partnership is one nurse visitation
model that operates in 40 counties across PA and is noted for its
strong evidence-based results and ability to break the cycle of poverty
for young women and their children. I understand the program saves
between $3 and $6 for every dollar invested. This is another example of
an excellent evidence-based program that can literally change the
trajectory of the lives of mothers and children. I know I am one of
many champions here in the Congress for this program.
As we create this funding stream which is money well spent on the
future of our country, can you tell us a bit about how you envision
this playing out.
Will the program be funded through Medicaid or some other funding
stream?
Do you see a role for this kind of program in overall health care
reform and if so, what role?
Also, how do you envision ensuring that programs across the country
are able to maintain the high standards that have given us such
positive outcomes from programs such as the Nurse Family Partnership?
Answer 1. Thank you so much for your support and deep commitment to
home visitation programs and for your commitment to evidence-based
interventions that improve the life trajectories of low-income and
disadvantaged children.
As you know, President Obama is committed to a comprehensive
``Zero-to-Five'' agenda, and the Recovery Act has made an important
down-payment on expanding access to essential programs by increasing
funding for Head Start by $1.0 billion, Early Head Start by $1.1
billion, and the Child Care Development Block Grant by $2.0 billion.
The President's budget blueprint calls for creation of a Nurse Home
Visitation Program, which will provide funds to States to offer home
visits by trained nurses to first-time low-income mothers and mothers-
to-be. As you note, the program has been rigorously evaluated over time
and has been proven to have many long-term positive effects. With
respect to financing, the President's budget blueprint creates a
separate mandatory funding program for the Nurse Home Visitation.
If confirmed as Secretary of HHS, I would look forward to working
with you and other Members of Congress to design, enact, finance, and
implement the most effective home visitation program possible for at-
risk children and families.
With respect to any new national program, including the Nurse Home
Visitation program, it will be critical that key program requirements,
funding mechanisms, measurement tools, and technical assistance are in
place to ensure that program elements that proved essential to the
success of early models are replicated in new sites.
QUESTIONS OF SENATOR HAGAN
Question 1. The threat of a flu pandemic is one of the most
important public health issues our Nation faces. The 2005 HHS pandemic
plan estimates that a severe pandemic could sicken 90 million
Americans. The plan estimates the direct and indirect costs for medical
care could reach $181 billion for a moderate pandemic. The previous
Administration made it a top priority by providing a detailed
preparedness plan and by requesting that Congress appropriate the
necessary funding for vaccine development, antiviral drug and vaccine
stockpiling, disease surveillance, and to promote preparedness at the
local, State, and Federal levels. Do you expect the Obama
administration to continue to emphasize the importance of a robust
public-private partnership to ensure that our Nation is fully prepared
for a flu pandemic?
Answer 1. Pandemic influenza remains a concern internationally and
domestically, and the Administration will continue to support HHS
efforts to ensure that the Nation is fully prepared. Our preparedness
efforts will continue to focus on expanding public-private partnerships
to help address the threat.
Question 2. USA Today recently reported a troubling increase in
resistance to the antiviral drug Tamiflu by H1N1 flu strains that are
circulating this season, and a new CDC report also raises concern about
the growing resistance of the H1N1 flu strain to the drug. What steps
do you expect HHS to take with regard to the growing resistance? And
what steps do you think are necessary to ensure that the pandemic flu
antiviral stockpile is not adversely impacted by this resistance issue?
Answer 2. HHS continues to conduct advanced research and
development of new antiviral countermeasures to combat these threats.
Although the current resistance relates to seasonal flu, we recognize
the potential implications to a novel influenza virus. If confirmed, I
will closely review the status of the Department's efforts in this area
and work with Members of Congress to ensure that appropriate steps are
being taken.
Response to Questions of Senators Enzi, Hatch, McCain, Murkowski,
Coburn, Burr, and Alexander by Kathleen Sebelius
QUESTIONS OF SENATOR ENZI
Health Care Reform
Question 1. When talking about his health care plan on the campaign
trail, President Obama stated several times that ``if you like what you
have, you can keep it.'' Expanding public programs like Medicaid will
create strong incentives for employers to no longer offer health
insurance. This means that potentially millions of workers with private
coverage could lose their existing coverage and be forced into a
government program which will not allow them to see the doctor of their
choice. Should public programs like Medicaid be expanded if it means
that millions of Americans would lose the health insurance that they
currently have?
Answer 1. We believe in the principle of choice. The President's
plan to assure affordable health insurance is built on strengthening
and expanding our existing health care system. Medicaid as a cost-
effective and appropriate strategy for expanding coverage to the lowest
income Americans. While the President's campaign plan did include such
an expansion, most Americans would be able to keep the coverage they
have today or choose from a set of private plans along with a public
plan option. We expect that the number of privately insured people will
rise, not fall, under health reform.
Question 2. Are you willing to explore new approaches to medical
liability reform, like the bill Senator Baucus and I have introduced,
which gives grants to States that develop new methods for resolving
medical malpractice claims and reducing medical errors, in order to
bring down health care costs?
Answer 2. Independent and objective studies have consistently found
that malpractice costs explain only a small part of medical costs.
However, clearly some doctors are facing exorbitant premiums and I
believe we all need to work together to look for creative solutions.
The most important goal is to improve health care quality for patients
to prevent medical mistakes from happening in the first place. This can
be done in a number of ways. One such way requires investing in health
information technology that can alert doctors when patients have
allergies or drug contra-indications to requiring transparency about
health care quality through reporting requirements.
I believe we should work to improve outcomes for patients without
being doctrinaire about solutions to this problem. If confirmed, I look
forward to working with Congress on this issue.
Question 3. I like to get things done. To get things done, I live
by what I call the 80 percent rule. We can agree on 80 percent of the
issues and about 80 percent of each issue, and we can get things done.
I think the 80/20 rule also holds true when it comes to health care
costs. About 20 percent of the population in the U.S. account for about
80 percent of the health care costs. I want all people to be able to
afford health care, but given the current fiscal environment, I think
it would make a lot of sense to target Federal funds to those really
sick people out there that don't have health insurance. Do you agree we
should target Federal funds to the sickest, costliest Americans?&
Answer 3. You raise two important points. First, I do agree that
our cost containment efforts must prioritize the 20 percent of patients
that account for 80 percent of health care costs. As such, my top
priority as Secretary would be to increase quality and reduce costs for
patients with chronic diseases such as obesity, cardiovascular disease,
and diabetes, as well as those facing end-of-life issues. Second, I do
agree that all our health initiatives, including health reform, should
reflect careful consideration of the needs of the most vulnerable among
us.
Question 4. Governor Sebelius, as you know, pharmacists play a
vital role in helping patients take their medications as prescribed.
When patients adhere to their medication therapy, it is possible to
reduce higher-cost medical services, such as emergency department
visits and catastrophic care. What policies can we put in place as part
of health care reform to encourage greater utilization of pharmacist-
provided services as a means to improve health care outcomes and reduce
costs?
Answer 4. Pharmacists play a critical role with respect to
improving health care quality and containing costs through patient
education, care coordination, and medical management. Health reform
will likely include expanded implementation of these services, and we
will rely on pharmacists to help inform our efforts. Further, if we
expand coverage and reimbursement for such services, pharmacists would
directly benefit.
Question 5. All health care reform proposals indicate an increased
need for primary care physicians to manage chronic illnesses, serve as
medical homes and perform preventative care. What steps would you
consider to incentivize more medical students to choose careers in
primary care?
Answer 5. I believe that we must address the primary care workforce
shortage on a number of fronts. First, we need to expand support for
workforce training programs, including title VII, title VIII, and
National Health Service Corps programs, which incentivize students to
pursue careers in the primary care health professions. Second, we must
tackle payment reform in the Medicare program to ensure that primary
care providers are paid fairly. Finally, we should take steps to
support the actual practice of primary care, which could include
assistance with adopting health IT or implementing disease management
and care coordination programs.
Health IT
Question 6. Secretary Leavitt and I both shared a passion for
technology. We worked together very closely on increasing adoption of
health information technology. I'm curious what type of a role you
envision for yourself in relation to health information technology?
What do you see as the Federal Government's role in encouraging
adoption of health IT?
Answer 6. We currently have a 21st-century operating room but a
19th-century administrative system for health care. One out of every
four health care dollars goes to administration. Only 17 percent of
U.S. physicians and 8-10 percent of U.S. hospitals have meaningful
electronic health records. In order to move our health care system
forward into the 21st century, we need to establish standards for
interoperability and privacy protections as soon as possible. We have
been talking about health IT for many years, and haven't gotten very
far. That's why the Government needs to make an up-front investment
that will be spent in a targeted, effective manner--to provide every
American with an electronic medical record, reduce medical errors, and
improve the quality of care for patients. The ultimate goal of this
effort is consumer empowerment; it will save not only money, but also
lives.
Question 7. What ideas do you have to assure rules and laws
designed to prevent profit from referrals to personally owned
facilities don't interfere with the flow of patient information?
Answer 7. It is fundamentally important that our health IT
infrastructure is fully interoperable to ensure the exchange of
critical health information among patients and their healthcare
providers. In addition, we must reduce unnecessary barriers to the flow
of information among providers, while ensuring that we protect patients
by minimizing improper referrals for care. If confirmed, I commit to
working to ensure an appropriate balance of those efforts.
Medicare
Question 8. The Medicare Trust Fund will be insolvent by 2019, and
States are reporting that they can no longer afford the rapidly
escalating costs of the Medicaid program. Given this impending fiscal
crisis, how can proposed expansions of these programs be sustainable?
How can we pay for the existing programs, as well as the proposed
expansions, in a way that will not do irreparable long-term damage to
our economy?
Answer 8. The cost pressure on Medicare and Medicaid is the result
of high health care costs in general. That is why reforming our health
care system to lower costs and expand coverage will help address the
long-term budgetary challenges facing these programs. Medicare and
Medicaid have performed as well as, if not better than, private
insurers on cost. Their growth rates are comparable to, and their
payment rates are lower than, those of the private sector. That said, a
top priority is to modernize these programs to make them leaders in
value-based purchasing and quality.
Question 9. In 2006, I traveled around Wyoming talking to seniors
and encouraging them to sign up for Medicare Part D. I held over a half
dozen town halls and got the same question at each town hall, ``my plan
doesn't cover the drugs I need.'' Each time this question was asked, it
was a Veteran doing the asking. This was because the Veterans Health
Administration uses price controls and inflexible formularies, which
often results in Veterans not being able to get the drugs they needed.
Will you support or oppose proposals that attempt to make the Medicare
Part D drug benefit more like the VHA, especially by imposing price
controls and rigid formularies that will restrict Medicare
beneficiaries' access to prescription drugs?
Answer 9. Repealing the non-interference clause is intended to
grant the HHS Secretary greater flexibility in ensuring affordable drug
prices. It does not mean creating a one-size-fits-all Medicare drug
plan for all Medicare beneficiaries. Yet, there may be some lessons the
Medicare program can learn from the VA, such as ways to promote lower-
cost generics when medically appropriate. Working together, I believe
we can improve Medicare Part D to adopt best practices by the VA and
also private purchasers, without creating a one-size-fits-all drug
benefit.
Question 10. The Government Accountability Office, the
Congressional Budget Office and several healthcare researchers have
previously documented how government price controls, like the ones
found in the Medicaid drug benefit, increase costs to other consumers.
Would you expand such government price controls over prescription
drugs, if it means increasing the costs for Americans with private
health insurance?
Answer 10. We need to develop careful policies to ensure that the
Federal Government does not overpay for any medical service, including
prescription drugs. At the same time, we need to make sure that changes
to Federal programs minimize any market distortions or cost-shifting.
But the goal should be to lower costs for all consumers. For example,
we can do more to promote more lower-cost generics.
Question 11. Being from Wyoming, which is more than just a rural
area, it is a frontier area, I too wanted to ensure seniors in rural
and frontier areas were able to get prescription drug coverage as good
as the rest of the country. To address these fears, Congress decided to
include a fallback plan for areas without sufficient plan choice. To my
surprise, this was an issue folks worried about for absolutely no
reason. For 2009, seniors in Wyoming have 48 different Medicare
prescription drug plans offering coverage. Do you know how many
Medicare prescription drug plans are offered in Kansas? Do you agree
this ``private health insurance model'' used for Medicare Part D is
working in rural areas and could serve as a valuable model for health
care reform?
Answer 11. We believe in building on the current system, preserving
the private health care system, and ensuring that all Americans can
choose their doctors. Americans should have the choice about where to
get insurance and what type of insurance they want. Under the plan the
President proposed on the campaign trail, the American people could
keep their current, private insurance. They can choose from an array of
other, private insurance options. They can choose their own doctors.
They can choose their own hospitals. They also can join a public plan
if they choose to do so. The Government is simply making it easier and
cheaper for them to make these choices, and making sure that insurance
companies aren't unfairly denying coverage to people who need it. It's
time to bring businesses, the medical community, and members of both
parties together to solve this problem for once and for all and I look
forward to working with you to achieve this goal.
In Kansas, there are 48 free-standing prescription drug plans, and
approximately 58 plans that are offered through Medicare Advantage
companies. In total, there are approximately 106 Medicare prescription
drug plans currently providing coverage in Kansas.
Question 12. Your testimony mentions ``CMS should ensure that all
those eligible for Medicare, Medicaid, and SCHIP are enrolled.'' How do
you propose we do this? Half of the kids eligible for SCHIP in Wyoming
aren't enrolled, despite an ambitious campaign by the State to enroll
more kids.
Answer 12. In our great Nation, 45 million Americans do not have
health insurance. This is a tragedy. Our public programs--Medicare,
Medicaid and SCHIP--are the bulwark against the lack of insurance in
our country. In fact, last year, the number of uninsured in our country
dipped only because of these public programs; the number of people in
private health insurance dropped. That's why it's critical that CMS
specifically, and HHS in general, work to expand coverage to those
eligible, especially in these difficult economic times.
Question 13. How much of every Medicare dollar spent is diverted
from patients because of waste, fraud, and abuse? How does that compare
with private health insurance plans?
Answer 13. We should have zero tolerance for fraud in the Medicare
and Medicaid programs, and, if I am confirmed as Secretary, I will make
it a top priority to manage these programs well. The extent to which
Medicare overpays relative to private sector is not precisely known,
but independent assessments have found that Medicare gets at least $6
for each $1 in investments to reduce fraud. Congress has given CMS and
HHS new authorities to reduce fraud, and we should make sure that all
of these new tools are employed to the fullest degree.
Question 14. Given that Medicare can arbitrarily impose price
controls and thereby shift its costs onto private insurance plans, is
it not true that any comparison of costs will be inherently and
unfairly biased in favor of Medicare?
Answer 14. Our goal is to end cost-shifting and to ensure lower
costs for all consumers.
NIH
Question 15. There are already centers across the country dedicated
to embryonic stem cell research. If Congress or the Administration were
to provide funding opportunities for embryonic stem cell research,
would you agree that the agency should support existing entities rather
than create duplicative efforts, such as a federally funded center that
will cost more to create and take funds away from grantees in other
research areas?
Answer 15. I support Federal funding for embryonic stem cell
research, and want to ensure that all research on stem cells is
conducted ethically and with rigorous oversight. NIH not only utilizes
researchers working at the agency, but provides grants to support the
work of scientists at universities and health care institutions across
our country. I look forward to working with the experts at the agency
to determine the best ways to finance the most promising stem cell
research, including supporting researchers who are already engaged in
cutting-edge stem cell research.
Question 16. As a part of the NIH reforms enacted in 2006, Congress
provided authority to the Director of NIH to make decisions based on
science rather than politics. What will you do to ensure that decisions
to fund research are made by the scientists and not the politicians?
Answer 16. The NIH grant process relies on the input of experts who
provide high-level analysis of the merits and value of grant
applications, and I believe it is important to ensure that the wisdom
of scientists continues to be the major force guiding grant making
decisions at the NIH. If confirmed, I look forward to working with
Congress to ensure that the NIH remains a science-driven institution,
funding the basic research necessary to help create breakthroughs in
medicine.
Question 17. Governor Sebelius, what is the role of HHS in seeing
that all Americans are able to access health care that reflects
cutting-edge research? How can we best be sure that the latest in
medical knowledge is not only being translated to the bedside, but is
also being implemented in communities?
Answer 17. President Obama supports increasing funding for the
National Institutes of Health (NIH). If confirmed, I want to not only
ensure that the agency has the resources needed to engage in cutting-
edge research, but to help more Americans access the innovations that
result from NIH research. If confirmed, I look forward to working with
members to determine ways to ensure that science-based programs and
effective treatments are available and accessible across the United
States.
Question 18. The safety and effectiveness of novel therapies is
best determined by clinical and translational research. How will you
increase the speed of this research while maintaining patient
protection during the conduct of clinical trials? Specifically will you
address the relative slowness of the IRB system?&
Answer 18. Both President Obama and I support increasing funding
for the NIH, and I hope to work with the scientists at the agency to
determine how increased resources might be used to improve the clinical
trial process and maintain safety for patients who enroll in these
important research efforts.
Question 19. How will you use NIH resources to fund important
clinical research, which may have a high potential benefit, but
uncertain commercial value?
Answer 19. Much of the NIH's work involves supporting investigator-
initiated research, and helping to fund the scientists in labs across
the United States who are engaging in important research that leads to
medical breakthroughs. If confirmed, I look forward to working with the
experts at the agency to ensure that the most promising research is
funded, and that science guides the research supported and carried out
by this agency.
Question 20. The integrity and validity of some scientific research
has been questioned due to potential conflicts of interest among
academic scientists with relationships with industry sponsors of their
work. This reaches into issues of continuing medical education, ghost-
writing of putatively scholarly articles, and food and drug samples for
doctors' offices. What specific steps will you take to minimize
conflicts of interest in the performance of federally funded research--
especially clinical and translational research?
Answer 20. Many universities have been developing or refining their
own conflict-of-interest guidelines, setting out disclosure
requirements and systems for adjudicating conflicts on a case-by-case
basis. The NIH can assist universities with advice and principles that
govern conflicts in the new system developed for the intramural
program. However, it is important to distinguish between ``interests''
and ``conflicts.'' We want our scientists to have interests. We want
them to share information and collaborate, including with the private
sector, to challenge each other's ideas and advocate for their own
ideas. We do not want, nor is it in the Nation's interest, to create a
world where university and government scientists are completely
isolated from industry scientists. That is not how science works.
A major component of avoiding significant conflicts--academic ties,
financial ties, institutional biases--is to insist on full public
disclosure of all such relationships. Case-by-case review of any
situation that is not completely straightforward would ensure that we
manage those conflicts that arise from legitimate interests, and we
prohibit interests that do not further the scientific mission of NIH
and its grantee institutions.
CDC
Question 21. Do you agree that the Director of the CDC needs more
flexibility to be able to more effectively allocate funds to public
health initiatives, programs and projects?
Answer 21. Yes. Currently, much of CDC's prevention funding is
disease-specific. Yet, we know that many chronic diseases, such as
heart disease or diabetes, share common risk factors including smoking
and obesity. Community prevention programs that increase physical
activity, improve diets, and reduce smoking will convey benefits across
a number of disease States. Flexibility in allocating funds would help
our efforts in this regard.
Question 22. We hear a lot about the need for prevention and how to
incorporate primary and secondary prevention into the daily lives of
all Americans. As the national leader on all issues related to health,
how will you establish a healthy environment at the Department that
provides a model for other companies and public agencies to follow?
Answer 22. The Department could take a number of steps to improve
the health of its employees. Such steps might include providing
healthier food options in cafeterias and vending machines, expanding
opportunities for physical activity, and ensuring all Federal campuses
institute smoke-free policies.
Question 23. As the leader of the Department of Health and Human
Services what will you do to ensure public health funding is used
efficiently and effectively? What will you do to help increase
accountability for public health programs?
Answer 23. In this environment of scarce Federal resources, we must
make doubly certain that we are spending tax dollars wisely and
efficiently. As such, I believe that HHS can play a critical role by
expanding quality measurement and reporting initiatives to better
integrate metrics specific to public health and prevention. Although
prevention awards made by HHS should allow flexibility to meet State
and local needs and health concerns, there should be a common
evaluation and analysis of effectiveness and efficiency, as feasible.
Programs that fail to meet established goals and objectives should be
eliminated.
Ryan White&
Question 24. Do you believe that funding allocations for the Ryan
White HIV/AIDS treatment program should be based on the principle that
the ``money should follow the patient?''
Answer 24. HIV is a problem across all parts of the United States,
and I believe that we need a national response to the epidemic. We
should be working to prevent regional disparities, and to ensure that
any American with HIV can get the necessary treatment and support
services. That's why the President and others have called for the
development of a National AIDS Strategy, to help us provide adequate
care and treatment to all Americans living with HIV, and prevent new
cases from occurring, particularly among high-risk populations. I also
believe that, as part of the overall health reform effort, we can work
to ensure that Americans with HIV, like Americans with other chronic
diseases, receive access to quality, affordable, and accessible health
care. Also, as you know, the last reauthorization of the Ryan White
CARE Act in 2006 includes policy changes that will improve our ability
to better track HIV cases and target the funding.
Question 25. The Ryan White program is the safety net for States
that need additional resources to provide medical care to individuals
with HIV/AIDS. Yet, funds have been used for services that are not
directly related to the health of the patient and not necessary to
receive care. What will you do to ensure that the Ryan White program is
truly the payer of last resort?
Answer 25. The Ryan White programs provide critical services and
supports to individuals living with HIV and AIDS. These programs fill
gaps left by public and private insurance programs. In the last
reauthorization of the Ryan White CARE Act, Congress established a
requirement that 75 percent of funds under Parts A, B, and C must be
for core medical services. These parts comprise, by far, the majority
of the funding for the Ryan White programs. The gaps in health and
related service needs that the Ryan White program must fill vary
dramatically from State to State and jurisdiction to jurisdiction.
While States can apply a higher portion of their funding for core
medical services, the flexibility to allocate up to 25 percent of funds
for other services enables funding to support essential services to
help to bring people into care and help individuals adhere to their
treatment regimens. If confirmed as Secretary, I will work to improve
chronic disease care and management, including administration of the
Ryan White programs, as part of our health reform process.
Question 26. This year the CDC reported that 56,300 new HIV
infections occurred--a number that is substantially higher than the
previous estimate of 40,000 annual new infections. Many are concerned
that not only is the epidemic larger than we previously thought, but
that testing initiatives are failing because of a lack in funding and
coordination. What will you do as Secretary of Health and Human
Services to coordinate CDC funding for HIV/AIDS prevention programs
(including testing initiatives) and HRSA funding for the Ryan White
treatment program?
Answer 26. The comprehensive national strategy for HIV/AIDS will
include a plan for coordinating efforts across departments such as HHS,
HUD, and VA. Within the department, we will work with CDC and NIH to
ensure that the strategy is based on sound science about what works and
that resources are allocated to implement the strategy. The strategy
will promote linking prevention with other services such as testing for
other sexually transmitted diseases and improving access to primary
care services. The strategy will also explore new incentives to achieve
recommendations for universal testing, broader uptake of HIV treatment
guidelines, and greater CMS involvement in efforts to assure testing
and quality improvement efforts by HIV providers receiving
reimbursement through Medicaid or Medicare.
Question 27. A recent study published in the Lancet showed that a
combination of universal voluntary HIV testing and immediate
antiretroviral treatment following diagnosis of HIV infection could
reduce HIV cases in a severe generalized epidemic by 95 percent within
10 years. As Secretary of Health and Human Services, how will you
increase awareness about the need for universal testing both at home
and abroad?
Answer 27. I support the development of a National AIDS Strategy,
which will allow us to coordinate our prevention and treatment efforts
in the battle against AIDS in the United States. The CDC estimates that
approximately one-quarter of people living with HIV are unaware of
their status, and I believe that a National AIDS Strategy will allow us
to develop better mechanisms for promoting and expanding the
availability of testing in the United States.
If confirmed, I also look forward to working with the Office of the
Global AIDS Coordinator in the State Department to help with
implementation of the President's Emergency Plan for AIDS Relief, and
to work with organizations and individuals around the world to help
people learn about their status.
Finally, we must work both at home and internationally to remove
the stigma associated with HIV and HIV testing, and help ensure that
testing is linked to care, treatment, and prevention programs.
FDA
Question 28. I am concerned about the FDA, its management, and its
ability to do its job with the resources it has. It is important to
have a strong FDA and maintain public confidence in the actions of that
agency. What steps will you take as Secretary of HHS to work with the
FDA Commissioner to insure that FDA is well-managed, well-funded, and
its inspection and surveillance capabilities are improved?
Answer 28. I believe it is essential to restore the leadership,
credibility, and authority of the Food and Drug Administration (FDA) to
protect America's food supply, assure the safety of our medicines, and
accelerate new cures and treatments for diseases like cancer, AIDS, and
Alzheimer's. If confirmed, I commit that the FDA will be free from
political interference, and I will work with the Commissioner to ensure
that the FDA is strongly committed to science and focused on its core
mission.
In addition, we should examine our process for certification of
food, as well as our process for assuring the safety of imported food.
We also need to make sure we're doing enough inspections and using all
available tools to protect our food supply.
Question 29. The drug industry user fees pay for more than half of
the FDA drug review program. This has caused a lot of consternation
among some patient and consumer groups concerned about potential
industry influence on the agency. Proposed legislation that would give
FDA regulatory authority over tobacco would rely on user fees to
support the new programs. Do you have concerns about the tobacco
industry paying for 100 percent of the proposed tobacco review program?
Answer 29. My understanding is that the proposed legislation is
written in such a manner to ensure that the user fee-collection system
will not give the tobacco industry influence with the FDA, nor will it
make the FDA dependent on continued tobacco sales.&
Neither the legislation nor the user-fee structure in the
legislation gives the tobacco industry any influence over how the FDA
would implement this legislation. Under this legislation, the tobacco
industry does not have any authority over how the money is spent, how
FDA sets its priorities, or how much FDA receives, nor does the amount
of the user fees collected depend on any of these decisions.&
The legislation further insulates the FDA from industry influence
or undue reliance on the manufacturers by ensuring that the amount of
user fees to be collected does not depend upon the amount of tobacco
used, but rather on manufacturers' share of the entire U.S. market.
Question 30. As the committee of jurisdiction over FDA, we must
consider the FDA regulation of tobacco in the context of its other
responsibilities. In recent years, Congress has tasked FDA with new
duties related to bioterrorism, pandemic flu, and mad cow disease. FDA
is asked to protect the public from potentially dangerous and
counterfeit drugs from abroad. Well-documented recent incidents
involving the safety of fresh produce and medical products prove the
point that FDA already struggles with the challenges of regulating an
expanding universe of products and threats. Shouldn't we focus on
better enforcing the dozens of tobacco regulations already on the books
instead of burdening an overworked and underfunded FDA?
Answer 30. I support giving the FDA the authority to regulate
tobacco, but recognize that the agency is strained in fulfilling
regular responsibilities. That is why we believe it needs additional
support. Despite significant progress in reducing rates of smoking,
tobacco use remains the No. 1 cause of preventable deaths in this
country. Smoking contributes to the development of heart disease,
strokes, emphysema, and cancers. Pregnant women who smoke are
significantly more likely to have low-birth-weight babies.
The President believes that the FDA could play a major role in
reducing tobacco use, by increasing oversight of marketing of tobacco
products; strengthening warning labels such as those implying healthier
products with words like ``lite'' tobacco; and banning additives, like
strawberry flavoring, that make smoking more attractive to children.
Reducing tobacco use and the prevalence of the diseases it causes will
significantly reduce health care costs and improve the quality and
longevity of life for countless Americans.
Question 31. Last year, the HELP Committee unanimously reported a
bill Chairman Kennedy and I developed with Senators Hatch and Clinton
to encourage cheaper versions of biologic drugs. We worked hard to
balance incentives, so biotech companies keep creating new life-saving
products, with a streamlined process, so the FDA can speed review of
biosimilars and consumers can realize cost savings. As we continue to
push for enactment of this legislation, I ask that you support our
efforts to maintain that balance between cost savings and preserving
innovation. Can you give us that commitment?
Answer 31. Patient care and treatment for conditions such as
multiple sclerosis and rheumatoid arthritis have been revolutionized
with the advent of biologic drugs. The President supports passage of
legislation that would create an expedited approval pathway for follow-
on biologics at the Food and Drug Administration, which would help
expand access to these safe and effective life-saving drugs. He
understands that such legislation must include an appropriate incentive
for continued innovation in this market.
Question 32. The current system of passive adverse event reporting
is underpowered to detect drug side effects that are not detected
during clinical trials, and cannot find evidence of an increase in the
incidence rate of common adverse events, such as cardiovascular
problems, that have a very high background in the general population.
Section 905 of the Food and Drug Administration Amendments Act of 2007
(P.L. 110-85) established a system of routine active surveillance for
post-market drug safety through a public-private partnership. This has
become known as the Sentinel Initiative. How will you ensure that this
important initiative continues and expands?
Answer 32. Both President Obama and I support efforts to revitalize
the FDA and improve the agency's ability to ensure the safety of food
and drug products used by American consumers. Active surveillance will
help us to detect possible issues with treatments as early as possible
and to alert health professionals about the potential dangerous side-
effects of drugs already on the market. I look forward to working with
the agency to ensure that HHS is using all available tools to prevent
exposure to unsafe products and minimize adverse events.
Question 33. What improvements should FDA make administratively to
better protect the safety of food and drugs imported into the United
States? In your view, can the safety, quality and authenticity of
imported products be assured by inspection or testing programs alone?
What additional resources would FDA need to monitor the safety of
medical products that are, either totally or partially, made overseas?&
Answer 33. This is an important issue that, if confirmed, I look
forward to working with Congress to address. Concern has been raised
that our current system is inadequate. Many have offered ideas related
to certification processes, which I believe should be thoughtfully
considered.
Question 34. In light of recent safety issues with imported
products, and data suggesting that drug importation would not save a
significant amount of money, would you as HHS Secretary lift the
prohibition on importation? If so, what amount of resources would the
FDA need to insure the safe commercial importation of drugs, and would
personal importation require more or fewer resources?
Answer 34. There are a number of options to lower the cost of
drugs. We need to examine all of these options, from expanding the use
of generic drugs, to providing greater flexibility to negotiate lower
priced drugs when appropriate, to allowing reimportation of drugs from
developed nations that, like the United States, have strict safety
measures. That said, the recent incidents involving heparin and other
consumer products has highlighted the potential challenges that must be
addressed before we import drugs that we can be sure are safe and
effective.
Question 35. The FDA is the gold standard among public health
regulators the world over. The label is the most important
communication mechanism for patients and providers about the benefits
and risks of a drug or device. Patients and doctors need to know that
they can rely on the label for accurate information. To ensure that
science is the guiding principle for all information with the label, I
believe the FDA must be the sole arbiter of what is and is not in the
label. Do you agree that we should rely on the agency to provide
accurate information in the label regarding the benefits and risks of a
medical product?
Answer 35. I am concerned about recent instances in which the FDA
took months to negotiate and approve safety-related changes to product
labeling. I know that Congress worked to address some of these concerns
in its recent FDA reauthorization by requiring companies to develop a
Risk Evaluation and Mitigation Strategy (REMS). The REMS process will
provide more tools to the FDA Commissioner in the agency's efforts to
improve patient safety and expedite labeling changes to protect
patients, and I look forward to working with the agency to uphold the
protections enacted by Congress if I am confirmed as Secretary. I also
look forward to working with Members of Congress to ensure the FDA
maintains its reputation as the gold standard of consumer protection,
and can continue to be relied upon by both patients and providers as a
source of unbiased information regarding the benefits and risks
associated with approved medical treatments.
Preparedness
Question 36. How can the Federal Government work most effectively
with the States to make sure our country is adequately prepared to
respond to the threats of terrorism and natural disasters?
Answer 36. Considerable progress has been made in recent years
toward better protecting the country from all manner of disasters,
including both natural events and the threat of terrorism. Working with
other partners in Government, including the Department of Homeland
Security, HHS has developed a series of plans and policies for
response. Through grants to States and localities, HHS has built
infrastructure for preparedness and response, trained and equipped
front-line responders, and developed better systems for communication
before and during a crisis. However, we are far from the level of
preparedness that we seek. Major gaps remain in many critical areas,
including surge capacity for mass medical/casualty care, rapid disease
detection, and food safety. The current Federal structure for public
health emergency preparedness has several specific problems. Major
limitations include: lack of strong leadership; understaffing; and
inadequate coordination within and across Federal agencies. This can
and must be improved.
Moreover, preparedness is a dynamic process that requires constant
attention and sustained investment. Sadly, much of what has been
accomplished in terms of building preparedness and response capacity is
now at risk due to budget cuts and the economic crisis. Successful
preparedness depends on vigilance, planning, and practice. If confirmed
as Secretary of HHS, I intend to focus early and consistently on these
issues. I will swiftly put in place an expert, experienced team to lead
HHS disaster preparedness and response efforts. We will work closely
with our partners at all levels of government, and with the private and
not-for-profit sectors to ensure we have robust, clear, and well-
established preparedness plans. This will include direct participation
in drills and exercises to ensure full understanding of the
complexities of the various potential scenarios, the level of
preparedness for differing contingencies, and the critical areas for
further work and development.
Comparative Effectiveness
Question 37. Recently, money for comparative effectiveness was
included in the stimulus package. Many policy experts are also calling
for more studies to compare the effectiveness of different treatments.
While I agree that it is important that we pay for proven
interventions, I am concerned that a drawback of such an approach can
be that such studies tend to be ``one-size-fits-all,'' with the winning
treatment recommended for everybody. At the same time, ``personalized
medicine,'' in which genetic screening and other tests give doctors
evidence for tailoring treatments to patients, is being touted as a way
to improve care, but can result in the recommendation of a more
expensive, but effective, treatment. How do you reconcile these two
approaches so that we pay only for what works, but still give people
the most appropriate care for them as an individual patient?
Answer 37. Comparative effectiveness researchers must acknowledge
and examine differences among patients that may affect risk for
disease, clinical presentation and diagnoses, and response to treatment
strategies, which includes personalized medicine. Both doctors and
patients must be active participants in comparative effectiveness
research initiatives as we move forward. The goal of this effort is to
improve care for patients, not hinder it through ineffective ``one-
size-fits-all'' approaches.
Question 38. Comparative effectiveness research has great
potential, but can be very difficult to conduct well. Do you have any
recommendation as to what sort of entities should conduct this
research?&
Answer 38. Many of our agencies--NIH, AHRQ, and CMS--have begun to
fund comparative effectiveness-related research, and to take the
critical step of developing appropriate methodologies for such
research. That said, we must be careful that political interests do not
influence either the objectives of the conduct of comparative
effectiveness research, and it may be appropriate to consider a new
entity to lead such research. If confirmed, I look forward to working
with the Congress as we move forward in this area.
Question 39. Comparative effectiveness has been touted as a
critical component to addressing the quality issues surrounding health
care reform. First, will this form of ``research'' be subjected to the
same patient protection rules (IRB, HIPAA) as standard clinical
research? Second, how will you increase the performance of necessary
comparative effectiveness investigations involving comparing the value
of two different drugs for the same medical purpose made by two
different drug companies--research that is rarely undertaken now?
Answer 39. I am committed to patient protection rules in research
and would expect them to apply to comparative effectiveness research.
Comparative effectiveness research can take the form of clinical
research, but it often takes the form of health services research.
Every project should be assessed prospectively to determine the risk to
patients and level of scrutiny required. In addition, the American
Recovery and Reinvestment Act supports improving the methodologies for
this type of research, improving its relevance and reliability.
Question 40. Comparative effectiveness, about which we have heard
so much, is really a form of clinical research. Will this form of
research come under the same rules as conventional clinical research,
including IRB and HIPAA privacy rules?
Answer 40. As I stated in my answer to the previous question,
comparative effectiveness research can take the form of clinical
research, but it often takes the form of health services research.
Every project should be assessed prospectively to determine the risk to
patients and level of scrutiny required.
Mental Health Parity
Question 41. Governor Sebelius, last year we passed landmark
legislation to guarantee parity in health insurance for mental
illnesses. How involved will you be in developing the regulations to
implement that landmark legislation? What is the current status of the
regulations?
Answer 41. I applaud Congress for taking action and passing mental
health parity legislation last year. I believe both private and public
insurance should include coverage of all essential medical services,
including mental health care; and that serious mental illnesses must be
covered on the same terms and conditions as are applicable to physical
illnesses and diseases. Although a firm time line has not been
established, I will work aggressively at HHS to implement the law
swiftly and fairly.
Management and Coordination
Question 42. Prevention research is both basic and clinical. It is
also supported by both the CDC and NIH. How are the efforts of these
two agencies coordinated to prevent duplication?&
Answer 42. President Obama has committed to expanding clinical and
community-based prevention to shift our health care system from an
``acute care'' system to one that prioritizes health promotion and
disease prevention activities. To be successful, prevention efforts
must be coordinated and integrated across all of the Federal agencies,
including CDC and NIH, but also AHRQ, which can help develop evaluation
metrics; HRSA, which supports education and training of primary care
providers; CMS, which can increase coverage for preventive services;
and each of the other Federal health agencies. If I am confirmed as
Secretary, I will develop an agency-wide strategy on prevention to
leverage resources, reduce duplication, and develop measurable
objectives to assess effectiveness.
Question 43. Many communities in the United States have many layers
of health care services including city, county and State. These various
agencies do not always work in a coordinated fashion with each other
and with the Federal Government to bring the best services to needy
people in these communities. How will you ensure that these agencies
work more constructively with each other and with your agency?
Answer 43. The increasing fragmentation of our Nation's health
system, which is reflected by the actual delivery of care as well as
the financing mechanisms, has resulted in serious problems with respect
to health care quality and efficiency. As you note, this challenge
exists at the State and local as well as the Federal level, and is
particularly problematic with respect to integration of health care,
public health, and social services. This issue is a top priority for me
and I believe the first step must be to focus on the programs,
policies, and operations of HHS. Specifically, as we look at individual
issue areas like public health or health care quality, we must examine
the activities and resources of each department to assess for
redundancy or duplication of effort, and we must integrate and
coordinate activities as appropriate. If confirmed, I would like to
hear your ideas and work with you to
accomplish a high-functioning and highly efficient department.
SCHIP
Question 44. What are your views on how the SCHIP program should be
reauthorized and what role will you play in enacting such a
reauthorization? What steps will you take as Secretary to ensure that
SCHIP dollars are used to provide health care coverage for lower income
children before expanding the program to cover children from families
with higher incomes?&
Answer 44. I commend Congress for acting quickly to reauthorize
CHIP earlier this year. Covering all children is central to our health
reform agenda. To accomplish that goal, we need new initiatives to
cover uninsured children who are eligible but not enrolled in CHIP and
Medicaid, and most significantly, broader health reform. Like you, we
believe in the importance of working to enroll lower income children,
who are most in need of CHIP's assistance. We support provisions, such
as those in the recently enacted CHIP reauthorization legislation, that
provide States with incentives to enroll the lowest income children. If
confirmed, implementing the reauthorized CHIP program will be a top
priority.
Early Childhood Education
Collaboration
Question 45. Historically early learning at the Federal level has
been exclusively under the jurisdiction of HHS. But at the State level,
early learning is often focused on State preschool, which is frequently
run by State education agencies--as it is in Kansas. States are working
hard to create collaboration among education agencies and human
services agencies to improve services to families. As Secretary, how
would you work with other agencies, particularly the Department of
Education, to improve the coordination and delivery of services to
children under the age of 5?
Answer 45. As a Governor, I learned that collaboration between
child care, Head Start, preschool, and other early childhood programs
at education agencies is essential to achieving the objectives we are
seeking for young children and their families. If confirmed as
Secretary of HHS, I plan to work very closely with Secretary Duncan to
coordinate our Federal early learning programs.
State Advisory Councils
Question 46. The Head Start Act requires States to create advisory
councils to better plan and coordinate the delivery of education and
health services to young children, including better connecting Head
Start, child care, pre-k, and the K-12 systems. As Governor of Kansas,
you signed legislation creating the Kansas Early Learning Coordinating
Council to help achieve those goals. What role do you see the State
Advisory Councils playing to improve the delivery of early childhood
services?
Answer 46. As you indicate, as Governor of Kansas, I established an
Early Learning Council to coordinate funding streams and link programs
serving young children and their families. I found this to be a very
effective strategy, and I believe State Advisory Councils and similar
coordinating structures are valuable tools that can help States find
creative and effective solutions to better serving children.
State Challenge Grants
Question 47. Right now many States struggle to connect Head Start,
child care, pre-k, and their K-12 systems. President Obama has proposed
creating early learning challenge grants to States through the
Department of Education, which would help States coordinate early
learning services. Little has been said by the Administration as to how
these new challenge grants would be coordinated with other Federal
resources and programs. Even less has been said about how these new
grants would be funded while also sustaining increases to the Head
Start and CCDBG programs contained in the ARRA. As Secretary, how will
you work with Secretary Duncan to ensure that these grants are not
duplicative of the purposes of the Head Start program? To what extent
should Federal support be extended to programs that serve more than
economically or otherwise disadvantaged children?
Answer 47. The President's proposed Early Learning Challenge grants
provides an exciting opportunity to encourage States to raise the
quality of their early learning programs, work to ensure a seamless
delivery of services, and ensure that children are prepared for success
when they reach kindergarten. If confirmed as Secretary of HHS, I
intend to work closely with Secretary Duncan on this initiative, and
work to coordinate early learning programs in both departments. I
strongly support finding effective and efficient ways for Federal
programs to meet the needs of socially and economically disadvantaged
children and their families.
Abstinence Education
Question 48. Do you think it is important to provide a clear,
undiluted message to our Nation's youth about avoiding behavior that
puts their health at risk?
Answer 48. I believe it is important to be honest with young people
about risky behaviors. In the context of abstinence education, I share
the Administration's support for programs that stress the importance of
abstinence while providing medically accurate and age-appropriate
information to youth who have already become sexually active.
Question 49. As the Secretary, would you support a dedicated
funding stream for Abstinence Education, separate from Comprehensive
Sex Education, to assure that the message about abstinence and primary
prevention is clear to our young people?
Answer 49. I support a wide range of public and private initiatives
to reduce teen pregnancy using evidence-based models. Specifically, I
share the Administration's support for programs that stress the
importance of abstinence while providing medically accurate and age-
appropriate information to youth who have already become sexually
active.
Question 50. If evidence exists demonstrating that abstinence
education is effective, would you support continued separate funding
for this approach?
Answer 50. I would welcome the opportunity to review evidence
regarding the effectiveness of abstinence-based education. As you may
know, a recent HHS-funded, experimental study of abstinence-only
programs found no behavioral effects relating to sexual abstinence or
condom use.
QUESTIONS OF SENATOR HATCH
Employer Mandate
Question 1. According to a study published in 2007 by the National
Bureau of Economic Research, an employer mandate of $9,000 for family
coverage would reduce wages by $3 per hour and cause 224,000 workers to
lose their jobs.
Harvard economist Amitabh Chandra stated that, ``the populist view
is this will only come out of profits. But, ultimately, the money will
come out of wages. And, worse, for some people, it can't come out of
wages.''
What are your thoughts on imposing an employer mandate during the
current troubling economic conditions on our labor sector and economy
in general?
Answer 1. Business leaders in America are at the top of the list of
those demanding health reform. They know that the real job killer is
the status quo, not policies that improve the efficiency and
accountability of the health system. They, along with workers and
families, will benefit from policies like improved prevention, better
chronic disease management, and health information technology that give
us more value for the health care dollar. Yet, the solution cannot just
come from Government. The President's campaign plan emphasized shared
responsibility. We believe that health reform can best be achieved with
everyone participating and contributing to Health reform.
Individuals have a responsibility to focus on health and
prevention.
Government has a responsibility to increase access and
improve affordability.
Insurance companies have a responsibility to ensure no
discrimination; and
Businesses have a responsibility to provide coverage or
pay for it if they don't.
This approach strengthens the employer-based system, ensuring it is
an option for those that want to keep it. Most large businesses are
currently offering coverage, and nothing would have to change for most
of them under health reform--except that health costs may come down as
system improvements kick in. The President also proposed on the
campaign trail to offer small businesses a targeted tax credit, since
these firms are the engine of job growth, particularly in our current
economic crisis, and yet are crippled by high premiums and need the
most help.
We are also committed to working with the American public and with
Congress on this and other issues related to health reform. The
President wants an open discussion about health reform and is open to
all serious options.
STAAR/Antimicrobial Resistance
Question 2. Members of this committee have become increasingly more
concerned about the issue of antimicrobial resistance and a number of
bills were introduced during the 110th Congress, including the
Strategies to Address Antimicrobial Resistance Act--or STAAR Act--which
I introduced with Senator Brown. With regard to your comments about the
role of the CDC, I am interested to hear your thoughts about this
topic.
In the STAAR Act, Senator Brown and I have suggested a holistic
approach to the problem of antibiotic resistance and establish a
network of experts across the country to conduct regional monitoring of
resistant organisms as they occur--which would be like a snapshot to
pick up on problems early. Would you agree that there is importance in
augmenting CDC's current surveillance system with some sort of expert
system?
Answer 2. Surveillance, including local and regional monitoring and
reporting of antimicrobial resistance, is critically important in
picking up on problems early. This kind of surveillance has to be part
of a comprehensive strategy to prevent antimicrobial resistance and its
spread.
Question 3. States have begun to require hospitals to implement
testing programs as a method to identify, and appropriately care for
patients with resistant infections. Do you see a role for the Federal
Government to promote testing to provide consistency and a higher
quality of care? If so, what do you envision its role to be?
Answer 3. The Federal Government can play an important role in
promoting high-quality care, particularly for those with resistant
infections. Strengthening surveillance, including promotion of patient
testing for resistant infections at the local and State level, will be
an important component of our Federal strategy. Disseminating evidence-
based guidelines for care of patients with resistant infections (or
those suspected to be resistant) and aligning financial incentives to
support the provision of high-quality care are two ways to promote
testing by providers.
Food Safety
Question 4. Over the years, there seems to be an increasing number
of food safety recalls, more recently with peanut butter and now
pistachios.
Do you believe this is a result of more adulterated food entering
commerce or has the Government's method of finding those adulterated
foods improved?
The method and process the CDC uses to identify the potential food
hazard is often criticized as being tedious and slow. Do you have any
ideas on how this process should be improved?
Answer 4. I agree that we must work to restore public confidence in
our food safety agencies. One of our most significant challenges lies
in the public's perception that we're not up to the job, which is the
result of several factors. For example, the Government's ability to
detect outbreaks and identify problems has remained problematic over
recent years. In addition, the globalization of the food supply and the
increasing complexity of distribution systems have introduced new
challenges resulting in high-profile national recalls. If I am
confirmed as Secretary, enhancing the Nation's food safety systems will
be one of my top priorities, and I would work with FDA, CDC, my
counterparts in other Federal departments, and Congress to make needed
changes.
Office of Generic Drugs
Question 5. In 1984, Congress passed the Drug Price Competition and
Patent Term Restoration Act, creating the generic drug industry and
saving consumers billions of dollars. Since two-thirds of today's
prescriptions are generic, I feel that this law has provided tremendous
benefits for consumers. The law guarantees patients that generic
products are safe and effective. It guarantees generic manufacturers
that their applications are reviewed within 180 days. And it guarantees
innovators that scientific experts have determined generic products are
bioequivalent. Unfortunately, questions have been raised on these
matters.
The biggest issue to me is that the Office of Generic Drugs (OGD)
has not received the same funding levels as the Office of New Drugs--
this office, receives guaranteed funding through user fees and
appropriations. Not only has the Office of Generic Drugs had inadequate
funding, it also has seen an erosion of its scientific base, and
declining morale due to funding constraints. In fact, the agency
admitted last year that it is still difficult to keep pace both with
incoming applications and with other matters requiring OGD resources
such as Citizen Petitions, lawsuits challenging the approval of generic
drugs, and providing guidance to industry.
I am concerned that we may have a system that is broken and would
appreciate your willingness to work with Congress to take the steps
necessary to improve this situation.
Governor Sebelius, I have a keen interest in the success of the
Office of Generic Drugs at the Food and Drug Administration. I have a
series of questions for which I would like your response. Let me add
that I recognize the need to move your confirmation along quickly. So,
while I would like to have your answers to these questions promptly--
and this should be achievable because I submitted the questions for the
HELP hearing for Senator Daschle and their answers should have been in
progress at the Department--I am comfortable with your providing
answers to the more detailed of these questions by July of this year.
Governor, there is a rising tide of concern about the quality of
generic drugs, which has been acknowledged by FDA's Janet Woodcock and
Gary Buehler, two very respected officials. Indeed, Congress has heard
serious criticisms about the Office of Generic Drugs (OGD) on a number
of fronts:
First, it is clear to all that OGD is seriously
understaffed. That leads to gaps in recruiting and training staff, and
to increasing workloads.
Second, as I will discuss further in subsequent questions,
credible concerns have been raised about the adequacy of OGD's
scientific infrastructure leading to questions about whether patients
can be assured that generic products now on the market are truly the
same as the innovator product.
Third, there are incredible lag times in review for a
disturbing number of products. In fact, last year, FDA told the
Congress that there was one product for which the application had been
pending almost 11 years. There were nine applications pending over 9
years, and 100 pending over 4 years. That seems extremely inconsistent
with the law's requirement for a 180-day clock.
Fourth, there are issues of morale relating both to the
other better-funded parts of the Agency and also to the delay in the
move to White Oak. I was the chief architect of the FDA Revitalization
Act which authorized the unified campus now at White Oak, which I
intended to serve as a magnet for academic creativity similar to the
National Institutes of Health Campus. Leaving OGD out seems to send a
clear signal that it is not as important as the other components.
So my question to you is quite simple. What will you do to reverse
these trends and to establish an adequate scientific base at the Office
of Generic Drugs? Will this be a priority for you?
Answer 5. Generic drugs play a critical role in keeping medicines
affordable. For these drugs to fulfill their role, Americans must have
access to them as soon as the law permits, and they must be as safe and
effective as the brand name drug. I will work hard to make sure that
the Office of Generic Drugs has adequate resources to review
applications in a timely manner and to carry out those reviews with the
best available science.
Question 6. I am aware that in April of last year, the FDA advised
Congress that from 10/01/07 until 4/15/08 the Agency had hired 31 new
staff representing a variety of scientific and clinical expertise who
were undergoing training and afterwards would be expected to make
significant contributions to review performance. Could you provide us
an update as to the total number of such new hires and their
contributions to review performance?
Answer 6. It is important for agencies to share information on the
impact of major personnel changes with Members of Congress and their
constituents. If I am confirmed as Secretary of HHS, I will ask FDA to
provide this information to you in a timely manner.
Question 7. Governor Sebelius, could you provide the committee with
the following information: The number of scientists hired in the last
year by FDA's Office of
Generic Drugs? An estimate of how many new scientists may be hired and
added to OGD this year? An estimate of the Agency's funding allocated
to the Office of Generic Drugs last year?
Answer 7. I agree it is important for Congress and the public to
understand basic facts about the Office of Generic Drugs. If I am
confirmed as Secretary of HHS, I will ask FDA to provide this
information to you in a timely manner.
Question 8. Let me turn now to some of my specific concerns about
the possibility that generic products approved by FDA may not, in fact,
be bioequivalent to the innovator product. A couple of years ago, FDA
approved generic copies of Wellbutrin, a widely used antidepressant.
Many patients complained the generics didn't work, leading to serious
problems like recurrence of depression and suicidality. An independent
study showed the generics dissolved much more quickly than the brand,
and this might be why the drug didn't work for some patients. In
September 2008, FDA announced it would conduct a human clinical trial
to address whether generic versions are truly the same as Wellbutrin.
Governor Sebelius, could you please answer the obvious question as
to why the FDA is spending taxpayer dollars to prove generic products
are the same as Wellbutrin when the law requires generic drug companies
to do that? Does this mean, in fact, that a generic product which is
not the same as the innovator is now on the market? But beyond that,
could you or your staff explain to the committee the fundamental
problem or reason that this situation could occur?
Answer 8. I agree that generic drugs must be shown to have the same
safety and effectiveness as the brand name product and that Americans
must have confidence in generic drugs. FDA therefore has two important
responsibilities. First, it must rigorously assure that the tests it
requires of generic drugs are adequate to establish that a generic is
as safe and effective as the brand name product. Second, it must
communicate effectively to the medical community and to the public
about the quality of generic drugs and the standards it uses to approve
them. I will work to ensure that FDA meets both of those
responsibilities.&
Question 9. Here is another specific case study I would like to
discuss with you. In fact, it was the subject of a colloquy among
several of us back in 2007, and involves bioequivalence methods for
locally acting drugs, which FDA's Office of
Generic Drugs (OGD) has recognized as a scientifically challenging
area. As with most locally acting drugs, OGD historically required
human bioequivalence studies for generic Vancomycin capsules, a locally
acting antibiotic for life-threatening infections. In 2006, OGD
abandoned human studies and instead said generics could be approved if
they dissolve rapidly in laboratory flasks. After the new method was
criticized as adopted without public process and apparently data-free,
OGD evaluated the method. The resulting data indicated the method was
flawed. So in 2008, OGD abandoned its 2006 method and reverted to human
studies, unless generics contain the same inactive ingredients in the
same quantities as the brand, in which case OGD now proposes a new
dissolution test. OGD's unexplained adoption and subsequent abandonment
of bioequivalence methods for this life-saving antibiotic seem to be
based in an unclear policy, if there is any policy basis at all, and do
not enhance public confidence in generic drugs. Thus: Would you please
provide the committee the record of FDA's development of these
bioequivalence methods, including the specific data sets and scientific
evidence FDA reviewed to: (a) develop the 2006 method, (b) abandon the
2006 method, and (c) adopt the 2008 method, the individuals who
participated in developing the methods, and any other records
discussing the methods?
Governor Sebelius, will you require FDA to test its latest
Vancomycin capsule dissolution bioequivalence method and fully discuss
in public forums, including FDA Advisory Committees, the scientific
uncertainties and any potential risk to patients associated with the
new dissolution method before using it to review or approve generic
drugs? If not, how can the public be assured that generic copies will
work the same as the brand, given that FDA already got bioequivalence
wrong once for this drug, when it adopted its now-abandoned 2006
method?
Answer 9. Your question reflects the importance of FDA
communicating clearly and effectively about its policies and changes to
its policies over time. If I am confirmed as Secretary of HHS, I will
ask FDA to provide information to you about the development of the test
methods used to evaluate the bioequivalence of Vancomycin, and I will
work to ensure the agency communicates effectively about its policies.&
Question 10. In another case, in 2003 FDA approved generic copies
of EMLA, a topical anesthetic. The approvals of EMLA generics were
based on a blood-level bioequivalence test method, but FDA's stated and
long-standing policy is to require human bioequivalence studies for
generic versions of topical drugs like EMLA.
Governor Sebelius, could you please explain how FDA could say
publicly that the science does not exist to allow use of blood-level
bioequivalence studies for drugs like EMLA, but nonetheless approve
generic copies of EMLA based on this method, and then used the flawed
EMLA precedent as a substitute for scientific evidence in proposing
bioequivalence methods for more complex topical drugs?
Would you please provide the committee the record of FDA's
development of the blood-level bioequivalence method for EMLA generics,
including the specific data sets and scientific evidence FDA reviewed
to develop the method, the individuals who participated in developing
the method, and any other records discussing the method?
Answer 10. If I am confirmed as Secretary of HHS, I will ask FDA to
provide information to you about the development of the test methods
used to evaluate the bioequivalence of EMLA.&
Question 11. As you know, bioequivalence is the key test for
approval of generic drugs. That said, appropriate methods for
establishing bioequivalence of drugs are important to assuring the
safety and effectiveness of both brand and generic drug products. In
this time of constrained resources and a drive for more science-based
policy decisions at FDA, do you agree that bioequivalence science and
method development should reside in a single place in the Agency and
not as competing efforts within both the Office of New Drugs and the
Office of Generic Drugs?
Answer 11. I agree that bioequivalence testing methods must be
based on the best available science. If I am confirmed as Secretary of
HHS, ensuring that FDA decisionmaking is science-driven and that FDA's
resources are used efficiently and effectively will be among my highest
priorities for the agency. Having said that, it is also important that
we avoid doing something that would inadvertently and unnecessarily
delay the approval of safe and effective generic drugs. If confirmed, I
will ask a new FDA Commissioner to review the question of
bioequivalence method development.
CDC/Prevention
Question 12. As a longtime proponent for preventive health
measures, I agree that the CDC plays a vital part in promoting good
health and preventing disease and I was interested to hear in your
testimony the figures related to health care costs that could be
avoided with sufficient investment in prevention. What are your
preliminary ideas about strengthening the agency's role and are there
other Federal agencies you see being involved with promoting the goal
of prevention in our health care system?
Answer 12. Wellness and prevention are urgent priorities. This
century's epidemic is chronic disease: over 70 percent of costs and
deaths result from it. Yet, we spend only 1 to 3 percent of our $2.6
trillion health system on prevention.
The Centers for Disease Control and Prevention plays a pivotal role
in promoting health and preventing disease. It has a large, talented,
and dedicated workforce with respected scientists working in multiple
disciplines. I will reinvigorate this team to focus on expanding the
knowledge base and actual implementation of prevention and public
health measures, commit to using evidence and science for public policy
decisionmaking, and recruit and retain the best public health
scientists. CDC should be a key part of health reform that improves
health care quality through a focus on prevention and wellness.
Specific priority areas of focus include obesity, smoking, HIV
prevention, and preparedness and response.
NIH
Question 13. With regard to funding for the National Institutes of
Health (NIH), what level of support do you think is needed to sustain
scientific progress and capitalize on the discoveries of the past
decade? &
Answer 13. NIH research is under severe stress: after seeing its
funding doubled between 1998 and 2003, the agency has been essentially
flat-funded for the past 5 years, with scant increases that are well
below the Biomedical Research and Development Price Index. This has
produced a 17 percent loss of ``buying power'' for the agency since
2003, and an acute drop in the success rates for grant applicants, now
as low as 10 percent for many NIH Institutes. A plan to achieve
sustained growth of the NIH budget is much needed. ``Feast or famine''
is to be avoided. President Obama's pledge to increase funding for
basic science research will enable the United States to regain its
leadership in the area of biomedical research, expand training
opportunities for the next generation of scientists, and stimulate
local economies to create jobs.
With regard to reauthorization, the NIH Reform Act of 2006
represented a major legislative effort, and at the present time there
are no fundamental issues that require such a complex undertaking in
the 111th Congress. However, NIH leadership believes that there are a
series of technical fixes that could clarify the intent or strengthen
the Reform Act, and, if confirmed, I hope to work with you to make
these changes.
Privacy
Question 14. With health reform in mind, the President and CEO of
the Mayo Clinic, Dr. Denis Cortese has said, ``Perhaps it's time to
stop talking about the French Model, or the Canadian Model, or the
German Model and start talking about the Utah model.'' What Dr. Cortese
is talking about is the care provided by Intermountain Healthcare in my
home State of Utah.&
A pioneer in the use of information technology, Intermountain has
long used electronic medical records to implement best practices and
clinical protocols, resulting in higher quality care that actually
costs less. For example, Medicare spending on patients with severe
chronic illness could be reduced by a third, with improved quality, if
the Nation provided care the way it's provided by Intermountain
Healthcare, according to research from Dartmouth Medical School.&
Essential to providing this high level of care is the appropriate
use of and sharing of patient identifiable health information. I am
very concerned that some of the provisions in the HIT (health
information technology) portion of the stimulus bill could actually
impede Intermountain and other providers' ability to provide this high-
quality low-cost care. It is incongruous that, on the one hand, we are
seeking to reform health care to provide better care at lower cost
while, on the other hand, the stimulus bill makes significant changes
to the HIPAA Privacy Rule that could actually impede providers' ability
to appropriately use health information to provide better care.&
One provision of particular concern reflects an unrealistic sense
of hospitals' ability to track and store patient health information
held in multiple information systems. The so-called ``accounting of
disclosures'' provision would, for example, require enormous
expenditures for a sweeping expansion of HIPAA's current accounting of
disclosures requirement to include all non-oral disclosures for
treatment, payment and health care operations. Intermountain Healthcare
tells me that it would cost approximately $250 million over 3 years to
develop the capacity to move toward compliance with the new
requirements. (Programming and other set-up cost approach $68 million;
storage costs for maintaining a rolling period of 3 years of audit data
would be approximately $78 million; Infrastructure development and
maintenance costs, including personnel for managing the audit data,
would cost approximately $106 million.) Importantly, the current HIPAA
rule rejected this approach because these disclosures are so routine,
so fundamental to the delivery of health care, and so voluminous.&
As you implement the privacy provisions in the stimulus law, I ask
that you look carefully at the cost of compliance and the impact on
both the delivery of cost-effective and high-quality patient care at an
individual patient level and, perhaps even more importantly, the
ability to use patient health information to deliver better care to
patient populations. Indeed, while electronic medical records are vital
to improving care for a specific patient, they are an irreplaceable
tool for improving care provided to all patients.&
With respect to the stimulus law's expansion of the current
accounting for disclosures requirement, the statute specifically states
that the regulations:
``shall only require such information to be collected through
an electronic health record in a manner that takes into account
the interests of the individuals in learning the circumstances
under which their protected health information is being
disclosed and takes into account the administrative burden of
accounting for such disclosures.''
Included in this review should be consideration of the number of
patient requests to date received by health systems for an accounting
of disclosures report compared to the number of patients for whom care
is provided by health systems, and whether there are alternate ways for
patients to learn about how their protected health information is being
disclosed. Can you please let me know if these important issues will be
part of the discussion as you begin to put forth regulations on this
issue?
Answer 14. It is absolutely critical that we ensure the privacy and
security of patients' medical information. Only if we gain the trust of
consumers will we ensure an effective and successful system. At the
same time, it is important that we are mindful of the very real
complexities and challenges faced by the providers and others in the
health care system who must implement the interoperability standards we
set. The best way to prevent problems from occurring is to move forward
with a transparent process--to maintain a dialogue with all affected
stakeholders. That way we can better understand and work to minimize
the potential burdens on providers while we ensure that patients'
information is confidential, secure, and used only in appropriate ways.
Question 15. I am disappointed that the security breach
notification requirements& the stimulus bill did not incorporate a
risk-based standard (such that affected individuals are notified only
when there is a reasonable likelihood of harm that could occur as a
result of a breach of personal health information). In putting forth
regulations relating to breach notification, please bear in mind that
patient notification when there is no discernable risk of harm could
unduly alarm the patient and multiples of such notifications could
result in a patient's failure to pay attention to a breach notice which
did require mitigating action on the part of the patient. I would be
interested in being kept informed with respect to the development of
these regulations, and your view of whether it is possible to somehow
minimize the likelihood of patient notifications of security breaches
that have no potential for harm.
Answer 15. Patient trust and confidence in the privacy and security
of their personal health information is critical to the success of an
interoperable health IT infrastructure. The breach notification
requirement established by the HITECH Act will improve transparency and
accountability. The earlier patients learn of a breach, the more likely
they will be able to take steps to protect themselves. However, we
recognize your concern that patients not be burdened with or worried by
an abundance of ``false alarms.'' In developing the guidance regarding
``unsecured protected health information'' and the regulations on
breach notification, we would welcome your thoughts and suggestions,
and, if confirmed, I would be happy to keep you informed of our
progress.
Question 16. Governor Sebelius, about 10 years ago, the Government
funded entity that oversees organ donations and distributions, UNOS,
proposed to move the allocation of donated livers from a State to a
regional system. That proposal was dropped due to significant and
substantive opposition from States like my own. Just a few days after
the start of this new Administration, UNOS revived this proposal and
could move as early as this June to give it final approval. I have
serious reservations about the substance and the timing of this
proposal and am very much opposed to it going into effect--is this
something you would be willing to take a look at for me?
Answer 16. Organ donation is an essential, life-saving gift from
one person to another, and it is essential to the public's trust in the
program that distribution be handled judiciously. If I am confirmed, I
will be glad to review this proposal.
Dietary Supplements
Question 17. Governor Sebelius, as you might know the Dietary
Supplement Health and Education Act of 1994 provides the FDA with the
authority to oversee and regulate the supplement industry. In December
2006, Congress passed the ``Dietary Supplement and Nonprescription Drug
Consumer Protection Act'' which the President signed into law and which
required for the mandatory reporting of serious adverse event reporting
for supplements. Do you agree with me, and with past Secretary's of HHS
and FDA Commissioners, that those laws are still adequate, not in need
of amending, and gives the FDA sufficient authority to regulate the
industry and protect the public/consumers?
Answer 17. Millions of Americans rely upon supplements to
supplement their dietary intake, believing such products can help
bolster their immune systems, protect them from disease, and slow down
the aging process. I know that many clinicians and advocates believe
that these products should be studied to make sure that the products
are safe and effective. The FDA has a responsibility--just as it does
with food, drugs, and devices--to make sure that the marketing claims
for supplements are truthful, and more importantly that Americans
cannot be harmed. Yet, the FDA must strike an appropriate balance
between regulating these products and maintaining access for consumers.
If additional authorities are needed, I will work with you to ensure
that consumer access is not compromised.
Question 18. Governor Sebelius, are you aware that in the last
several years the Lewin Group (a nationally recognized health care
consulting firm) has both published and testified before Congress that
dietary supplements not only improve health and quality of life but
reduce health care expenditures by billions of dollars over a 5-year
period--more specifically: (1) that the daily intake of 1,800
milligrams of omega-3 fatty acids can reduce the occurrence of coronary
heart disease (CHD) resulting in a cost savings of in excess of $3.1
billion due to CHD being avoided; (2) that a daily intake of 1,200
milligrams of calcium with vitamin D can prevent nearly a million hip
fractures from occurring resulting at a cost savings of $13.9 billion,
and, (3) that if 10.5 million additional women of child bearing age
would take 400 micrograms of folic acid daily, that more than 600
babies would be born without neural tube defects and result in a cost
savings of $1.3 billion. Hearing those benefits and cost savings would
you be so inclined to include those three FDA fully recognized health
claims and supplements in your health care reform package?
Answer 18. As a part of his health reform agenda, the President
committed to covering evidence-based prevention services in public
plans as well as private plans offered through the Exchange.
QUESTIONS OF SENATOR MCCAIN
Health Reform
Question 1a. Employer-based health insurance is an important
component of our Nation's health care system. President Obama's budget
states that any health reform initiative must allow those with
employer-sponsored coverage the option of keeping their coverage. At
the same time, many have proposed that a Government-run health plan be
made available to all Americans. I have many concerns about such a
proposal and fear that millions of Americans who already have insurance
could be forced into a Government-run plan (Lewin study estimates 120
million Americans could lose their employer-based coverage and be
pushed into a Government-run plan).&
Do you support the creation of a national or regional-based health
insurance exchange?
Answer 1a. The President's campaign plan proposed a health
insurance exchange. It would provide consumers with easily accessible
information on health plans and pool purchase power for more
affordable, high-quality coverage. We look forward to working with
Congress on these and other ideas.
Question 1b. Would you support the creation of a Government-run
plan to function in a health insurance exchange? If so, how do you
envision the Federal Government competing against private insurers?
Answer 1b. The President has outlined a series of principles that
he would like reforms to encapsulate, including the principle of
choice. The President's campaign plan proposed a public option
alongside private insurance options in a National Health Insurance
Exchange, which would give Americans greater choice of plans. Such a
proposal would also ensure greater competition, pushing private
insurers to compete on cost and quality instead of gaming the system to
avoid costlier patients. At the same time, he recognizes the importance
of a level playing field between plans and ensuring that private
insurance plans are not disadvantaged. That said, the President is open
to exploring all serious ideas that achieve these common goals. He will
work with Congress on this and other elements of the plan.
Question 1c. Would there be a minimum benchmark for benefits? If
so, how would this level be determined?
Answer 1c. The President's goal is to provide all Americans with
affordable, accessible, high-quality health care. We look forward to
working with Congress on this and other ideas.
Question 1d. Would you support a mandate requiring individuals to
purchase health insurance coverage? If not, would you support a mandate
requiring employers to provide coverage to their employees?
Answer 1d. The President believes that every American should have
affordable, high-quality coverage. Making health insurance affordable
is key to making it universal. Most people don't have coverage because
health insurance is unaffordable. As premiums have doubled in the last
8 years, the problem has only gotten worse. As for specific proposals,
there are many ideas in Congress and in the country on how to cover all
Americans, and we look forward to working with leaders in the House and
Senate to finally achieve this critical goal.
Question 1e. How much would running a Government-run plan cost and
where would the money come from?
Answer 1e. To be clear, the President's campaign health care plan
envisioned a public plan operating in a health exchange alongside
private plans; private insurers would continue a role under his vision
for health reform.
Ensuring affordable coverage will require an up-front Federal
investment. This investment, along with the Recovery Act initiatives,
will yield long-run cost savings for both taxpayers and the Federal
Government. The President is committed to working with Congress to find
responsible ways to pay for this investment. This includes policies to
reduce health care costs and premiums for families through the
following improvements aimed at increasing the efficiency of the health
care system:
Expansion of Health IT, which should reduce unnecessary
spending in the system that results from preventable medical errors and
duplicative tests and facilitate improvements in the quality of health
care.
Improving prevention of illness through wider use of
vaccines, screening tests, and proven community-based programs.
Expanding the use of case management for chronic
conditions such as asthma, diabetes, and congestive heart failure. This
should reduce hospitalization costs and save money.
Ensuring that providers and patients have access to
comparative effectiveness information on what interventions work best
to help patients get the best value for their treatment dollar.
Our goal is to fix our broken system and cover all Americans in a
fair and fiscally responsible manner that improves quality and lowers
the long-run growth of health care.
Question 1f. How would you ensure that those who are happy with
their employer-based coverage can keep that coverage and not see
premium increases due to the new Government-run plan?&
Answer 1f. We believe successfully reforming the health care system
involves building on the current structure, preserving the private
health care system, and ensuring that all Americans have choices. As
the President has said, he wants to make sure that if you like your
health care, nothing has to change. In fact, health coverage will be
more affordable to employers and workers as the policies to drive
efficiency and value in the system take effect. We look forward to
working with Congress to develop a plan that builds on the system we
have while reforming it to ensure health care is affordable and all
Americans are covered.
Question 2a. Under current law, individuals who receive employer-
based health insurance can exclude those benefits from taxation--in
effect, a huge tax subsidy that the Congressional Budget Office (CBO)
estimates is about $260 billion per year. Unfortunately, this is also
an unfair tax advantage that is not enjoyed by the millions of
Americans who do not receive employer provided health benefits. In my
view, we must reform our tax code to make it fairer for all Americans
by replacing the existing tax exclusion with refundable tax credits for
all Americans, regardless of income level.&
Would you support changing the tax code to promote fairer treatment
for those that do not receive tax benefits from their employers?
Answer 2a. The President believes health reform should build upon
the existing employer-based health care system, through which the
majority of Americans receive their health care. The tax exclusion
contributes to sustaining this system. That said, he recognizes that
many members of Congress have views on that subject, and he and I look
forward to working with Congress to examine ways to ensure the strength
of our existing employer-based health care system while improving
affordability and accessibility for all Americans.
Question 2b. If you would support removing the tax exclusion, what
would those funds be redirected to cover?
Answer 2b. The President has stated that he would consider
addressing reforms of the tax exclusion among other sources of
financing if that is what it takes to cover all Americans. However, he
has not proposed removing the tax exclusion because this would result
in a tax increase for millions of middle-income Americans at a time
when they cannot afford it.
Question 2c. Would removing or capping the exclusion, cover the
estimated cost of the Obama health plan?&
Answer 2c. The President's budget includes proposals that would
raise $634 billion over 10 years for health reform. About half of this
funding would come from ideas to improve efficiency and accountability
and promote shared responsibility in the health system. The President
is committed to reducing the cost of the system as well as finding ways
to pay for it. His budget also included a proposal to return to the
Reagan-level of tax deductions for high-income taxpayers. This reserve
fund is significant but not enough to fund health reform. We look
forward to working with Congress to examine ways to fund needed up-
front investments in our broken health care system, with the knowledge
that such up-front investments will be more than recovered through
long-run savings.
Question 3a. Even though the Medicare program is outside the
purview of the HELP Committee, no one can deny its influence on every
aspect of our health care system that is under our jurisdiction.&
How soon do you expect to have a CMS Administrator in place?&
Answer 3a. If confirmed as Secretary, one of my highest priorities
will be to ensure that we have the highest caliber individuals to
administer all of HHS's agencies, including the Centers for Medicare
and Medicaid Services (CMS). For CMS, I will ensure that the
Administrator has the necessary experience and trust of Congress to
successfully administer the Medicare, Medicaid, and CHIP programs. And
that person should also have the necessary experience to lead the
transformation of the U.S. health care system to produce greater health
care outcomes and value for all consumers and businesses. It is my hope
that we can have a CMS Administrator who meets these criteria in place
as soon as possible.
Question 3b. How do you plan to reform the Medicare program and
what steps will you take to reform its payment system?
Answer 3b. The Medicare program faces many challenges, including
transforming its fee-for-service program to ensure that it better
rewards quality outcomes, primary care, prevention, and care
coordination. I also believe the program can create strong incentives
for Medicare Advantage and prescription drug plans to create greater
value for their Medicare enrollees. Finally, the Medicare program's
resources are not sufficient for the long-run. If confirmed as HHS
Secretary, I will work with the Congress to undertake a fundamental
review of Medicare's payment systems to ensure that the program rewards
overall value of care. The President's Budget proposes several steps to
move in this regard, such as encouraging more integrated and
coordinated physician care and increasing incentives for hospitals to
reduce avoidable and costly re-admissions. I look forward to working
with Congress to implement these and other payment reforms.
Question 3c. What is your view on reforming Medicare payments to
encourage high-value care?
Answer 3c. Reforming Medicare's payments systems should be a
priority element of any health reform effort. Such reforms should
ensure that Medicare beneficiaries receive the highest quality care and
that Medicare trust fund resources are used prudently. Moreover,
private insurers generally follow Medicare's lead, and we should expect
that enacted Medicare payment reforms will set the example for the
entire health care system. I share the President's view that Medicare's
payment system for physicians should promote greater primary care and
preventive care to ensure that chronic conditions are prevented and
better managed to reduce overall health care costs. In addition, the
President's Budget proposes several very important Medicare payment
reforms, such as bundling of hospital and post-acute care services.
These reforms will move Medicare away from paying for care in a silo-ed
fashion, which currently rewards health care providers for the volume
of the care they provide rather than the value of the care.
Comparative Effectiveness Research
Question 4. I believe that, if done correctly, comparative
effectiveness research can help provide patients and their doctors with
the vital information necessary to make the right decisions in an
individual's medical case. However, I have also heard from many patient
and provider groups who have expressed concerns about just how this
research will be conducted and used. While there would be benefits,
they are justly concerned that such research can be used to hamper or
impede access to beneficial care. I worry that comparative
effectiveness research could be used in a similar fashion to NICE in
the U.K., where centralized authorities decide which cancer patients
can receive life-saving care and which are denied access to beneficial
treatment options.&
Do you share these same concerns?&
Answer 4, Comparative effectiveness will help consumers and
providers make informed health care decisions based on effectiveness
and appropriateness of treatments. Business groups, including the
National Business Group on Health, support this effort because it will
bring value to health care spending. Comparative effectiveness is about
spreading information on what's most effective; it has nothing to do
with Government dictating choices. In fact, it is prohibited by law for
Medicare to use comparative effectiveness research for payment
decisions.
Question 5. I think that any comparative effectiveness research
financed or conducted by the Federal Government should not be paired
with regulatory powers to dictate practice patterns. Acting National
Institutes of Health Director Raynard S. Kington testified that his
agency may use money from the stimulus bill to fund grants for
comparative effectiveness research that includes comparisons of the
costs of the treatments involved.&
What assurances can you offer the American public that the funds
provided in the stimulus bill for comparative effectiveness research
will not be used to create restrictions to access to care?
Answer 5. I can assure you that the information gleaned from
comparative effectiveness research will not be used for coverage
decisions for Medicare, as dictated by a 2003 law.
Question 6. Medical research and technology is moving increasingly
towards individualized medical treatments, that is, the future of
medicine seems to be moving towards treatments that are tailored to
individual patients and may not work for everyone. However, this
approach could potentially conflict with efforts to compare the
effectiveness of treatments based on an ``average'' patient. I'm
concerned that individuals in vulnerable populations, such as
minorities, women, or individuals with multiple conditions could be
squeezed into a one-size-fits-all treatment model.&
How will you ensure that comparative effectiveness research
supports personalized medicine?
Answer 6. The goal of comparative effectiveness research is to
inform physician and patient decisionmaking--to empower doctors and
patients with more information on quality care. It is not to mandate
specific care. We are mindful of the need for research to address the
needs of each patient and that is our goal with this and other
research.
Small Business Health Insurance Market Reforms
Question 7a. I am greatly concerned over the wide disparities in
health insurance costs, quality, and coverage across the Nation, and
especially between States in the small business health insurance
market.&
How would you propose to solve this important issue that is
overburdening our Nation's small businesses?&
Answer 7a. The President's campaign plan proposed a health
insurance exchange to enable small businesses and individuals to pool
together to obtain affordable health coverage. He also proposed a small
business tax credit to help make health care affordable for small
businesses to cover their employees. The Congress also has many ideas
on this subject. We look forward to working with you on this and other
ideas.
Question 7b. Would you object to a national health insurance
market/exchange?
Answer 7b. No, I would not. It was part of the President's campaign
health care plan.
Question 7c. Would you allow this exchange to facilitate having
people buy insurance across State lines? Could people simply buy
insurance in a national exchange or will there also be a minimum
benefit design too?&
Answer 7c. There are many possibilities for how an exchange could
be run to promote competition, transparency, quality, and
affordability. We look forward to working with Congress to further
those goals through a reform such as a health insurance exchange.
Question 7d. Who would be responsible for a minimum benefit design
and how would you guarantee that it could be adapted as medical care
evolves through innovation and technological breakthroughs?
Answer 7d. Our Nation is a world leader in the development of new
technologies and treatments for some of humanity's most devastating
illnesses. Ensuring the accessibility of effective innovations is a
hallmark of any comprehensive health reform. If confirmed, I look
forward to working with Congress to address this and other issues
related to ensuring affordable, high-quality health care for all
Americans.
Health Information Technology
Question 8a. The recently enacted economic stimulus bill provided
$19 billion for health information technology adoption. Given the poor
track record of the Federal Government's efforts in modernizing and
updating our agency record systems in agencies such as the FBI and FAA,
many are concerned that this will not be sufficient funding.
Given the poor track record of the Federal Government in its
efforts to modernize agency record systems, do you believe additional
money will be required for this conversion to electronic medical
records? If yes, how much?&
Answer 8a. The Obama administration is committed to meeting the
Recovery Act goal of ensuring that every American has an electronic
medical record. The Recovery Act's investment of nearly $20 billion
will allow HHS to make critical up front investments to facilitate the
adoption and use of health IT, while the provision of financial
incentives through Medicare and Medicaid beginning in 2011 for the
meaningful use of health IT will further advance this goal.
Question 8b. What steps will you take as Secretary to ensure that
this $19 billion of taxpayer dollars will lead to interoperability
among the different electronic records systems used by providers and
hospitals?&
Answer 8b. A nationwide interoperable health IT infrastructure is a
fundamental building block for broader health reform. A key Federal
role is ensuring that systems are interoperable and that patient
privacy is assured, and the Recovery Act gives HHS the tools to fulfill
that role. The standards and certification process established in the
Recovery Act will assure providers that the electronic medical record
systems they purchase are indeed interoperable, while spurring
innovation and competition as vendors develop products that meet these
standards and the needs of providers in the system.
We have been talking about health IT for many years. If confirmed,
I look forward to making sure that the Recovery Act investment will be
spent in a targeted, effective manner to:
provide every American with an interoperable electronic
medical record,
reduce medical errors,
protect patient privacy,
improve the quality of care for patients, and
reduce costs in the healthcare system.
Question 8c. Converting to electronic medical records will be an
expensive process at every level but especially at the provider level.
What steps will you take to ensure that providers, especially those in
small practices, are not overburdened with Health IT costs?
Answer 8c. Many physicians want to adopt health IT, but do not have
the ability to invest upwards of $40,000 in the technology systems. By
providing physicians and other providers with financial assistance for
adoption and use of interoperable HIT, we will help reduce this burden
on providers. The Recovery Act creates grant and loan programs as well
as education and technical assistance opportunities to help providers,
especially those in small practices, to overcome barriers to adoption
and assist them in using these systems to reduce costs and improve
quality for their patients.
Indian Health Services
Question 9. As you know, the Federal obligation for the provision
of health care services to Indians arises out of the special trust
relationship between the United States and Indian tribes. I believe
that much more needs to be done to address health care needs on Indian
Reservations and in Alaskan Native Villages and that is why I have
sponsored efforts to elevate the position of Indian Health Services
Director to the status of an Assistant Secretary in the Department of
Health and Human Services.&
As the Secretary of Health and Human Services, would you support a
similar provision that establishes the post of Assistant Secretary for
Indian Health?
Answer 9. I understand that tribes have recommended this for many
years because of the importance of the Government-to-Government
relationship, the trust responsibility of all agencies in HHS to tribes
and their members, and their desire to have increased access to the
Secretary to make sure the needs of IHS are addressed. I plan to review
this proposal and try to find the best solution to ensure that the
health and human services needs of Native Americans are addressed at
the highest levels throughout the Department. If confirmed, IHS will be
a high priority for me, and that priority will be reflected throughout
HHS and its activities.
Question 10. There's all too often a perceived disconnect between
the IHS and the higher functions at DHHS. In particular, DHHS hasn't
adequately incorporated tribal recommendations in its final budget
requests, despite tribal participation throughout the budget process
via the National Indian Health Board and others. This has resulted in
the Administration budgeting for far less than what the tribes tell us
they require.&
Can you assure the committee that you will cultivate collaboration
between the Assistant Secretary for Health, the IHS Director, tribes,
and tribal organizations when developing a responsible IHS budget to
raise the health status of American Indian and Alaska Natives?
Answer 10. Yes. If confirmed, I will work to improve collaboration
between all parties involved to improve the health status of American
Indians and Alaska Natives. As you know, the Department conducts
ongoing consultation with tribal Governments and tribal leaders. I want
to use that consultative process to identify ways we can improve IHS
and other HHS services, coordinate efforts to ensure the budget
supports those services, and make them reflect a true partnership
between the Department and Native communities. I am confident that Dr.
Yvette Roubideaux, the President's nominee for IHS Director, and Dr.
Howard Koh, the President's nominee for Assistant Secretary for Health,
are equally committed to those goals.
Question 11a. I believe we must do more to ensure the ability of
the elderly and disabled American Indians and Alaska Natives to access
Medicaid and Medicare, in particular, the prescription drug benefits
available under Medicare Part D. Currently, the Indian Health Care
Improvement Act authorizes the use of Indian Health Service funding to
pay for Medicare Parts A and B premium payments for Indians, but not
for Part D.
Would you support amending the Indian Health Care Improvement Act
to allow the use of IHS funds to pay the monthly premium of an Indian
who is a Medicare Part D eligible individual enrolled in a prescription
drug plan or Medicare Advantage-Prescription Drug Plan (MA-PD)?&
Answer 11a. I definitely agree we need to do more to ensure elderly
American Indians and Alaska Natives and those with disabilities have
access to the prescription drugs and other Medicare and Medicaid
services they need. If confirmed, I will give serious consideration to
any feasible proposals that may be advanced as amendments to the Indian
Health Care Improvement Act. I hope to have the opportunity to work
with you toward that end. Of course, as you have noted, an infusion of
IHS funds will be necessary to accomplish the goals of any such
proposal.
Question 11b. Second, will you continue the administrative policy
to deem IHS and tribal health care ``creditable coverage'' or, if not,
whether you would support a legislative fix?&
Answer 11b. It is my understanding that any provider of
prescription drug coverage can have its coverage deemed as ``creditable
coverage'' provided that beneficiaries receive at least the same level
of prescription drug coverage as provided in Part D. As required by
CMS, the IHS has performed an analysis of its drug coverage and has
certified with CMS that its drug coverage meets the requirements of the
creditable coverage definition. While I do not anticipate amending this
policy, if confirmed, I will examine this issue closely to determine
whether a change--administrative or legislative--is necessary.
QUESTIONS OF SENATOR MURKOWSKI
Health
Question 1. Alaska's youth suicide rates have spiked; we witnessed
146 deaths by suicide in 2007, almost a 15 percent increase over
previous years. In December alone, we lost two young lives to suicide
in a town with less than 900 people and as I'm sure you know, Native
American/Alaskan Native and Hispanic youth having the highest rates of
suicide-related fatalities. How would you reduce youth suicide rates?
What more can we do to stem the tide in the rising number of youth
suicides?
Answer 1. I am aware of the devastating problem of suicide,
especially among American Indian and Alaska Native youth, and solutions
to this problem require the participation of many partners throughout
the Federal Government and in tribal communities. For example, we need
teacher and other staff education in schools to make sure they are able
to identify and help at-risk kids. We need creative solutions, such as
telepsychiatry, to bring needed mental health services to rural
communities that have shortages of local providers. We need to
strengthen policies and regulations to ensure that youth who attend
boarding schools or regional treatment centers are still covered for
needed mental health services.
All interventions must be culturally competent, incorporate
strengths and positive aspects of Native culture, and integrate with
broader efforts to address the poor economic and social conditions in
Indian communities. Finally, adequate funding is the linchpin to the
success of any intervention--the significant underfunding of IHS has
limited the ability to provide adequate mental health services and
recruit and maintain an adequate number of providers in many
communities. I look forward to working with Congress to find solutions
and resources for this devastating problem.
Education
Question 2. In 2005 and in 2008 the Office of Head Start (OHS) told
the Chugachmuit and Aleutian Pribilof Islands Association Head Start
agencies (each serving a collection of very small communities) that
they would not be able to operate a center-based program in communities
with fewer than 12 children enrolled. The Office of Head Start has
confirmed, after closing at least one Head Start center in Alaska for
as much as a year, that there is no statutory or regulatory minimum
class size for Head Start centers, just a regulatory
``recommendation.'' Will you confirm that under your leadership, the
Office of Head Start will never again threaten to close, or close a
Head Start Center in Alaska's very small communities if the only reason
is that there are fewer than 12 children enrolled, without the consent
of the grantee?
Answer 2. Ensuring access to quality early childhood programs to as
many eligible children as possible is an important priority for the
Obama administration. I will look carefully at the Head Start
performance standards and take into consideration the special needs of
rural communities and Native Alaskans served in the Head Start program.
We need to make decisions based on the dual goals of flexibility in
serving rural areas and assurance of viable, high-quality programs. We
need to think creatively to attain those goals, and I want to work with
you and others in Congress toward that end.
Indian Health
Question 1a. In my judgment, one of the most important
responsibilities of the Secretary of Health and Human Services is to
provide leadership to the Indian Health Service. Would you agree with
this characterization and what role do you see yourself playing in
improving the healthcare provided to America's first peoples?
Answer 1a. I agree completely. If confirmed, I intend to work with
the Director of the Indian Health Service, the Centers for Disease
Control, the Administration for Native Americans, and all appropriate
agencies within the Department and across the Government to advance the
mission of raising the physical, mental, social, and spiritual health
of American Indians and Alaska Natives. President Obama has nominated
Dr. Yvette Roubideaux to lead IHS, and I am excited about the
extraordinary talent, experience, wisdom, and energy she will bring to
that job.
The task is both enormous and urgent. The IHS patient population is
underserved. As you know all too well, that is due, in large part, to
historically inadequate funding--for direct and contract health
services, for facilities, and for personnel--and I am pleased that the
American Recovery and Reinvestment Act (ARRA) and the President's
budget are signaling an effort to begin to address that funding
shortfall. Of course, many other factors contribute to the significant
health disparities facing the Indian population in both rural and urban
areas. In addition to more funding, we need strategies to address the
diabetes that is epidemic among American Indians and Alaska Natives,
the high youth suicide rate you raised earlier, and the underlying
causes of these and other threats to the IHS population's health. Just
as we need to do across the country, we need to emphasize prevention,
and that includes efforts like ensuring that those living in rural
areas have greater access to affordable fruits and vegetables and other
healthy foods. We need to look at the whole picture, and that's what
Dr. Roubideaux and I hope to have the opportunity to do.
Question 1b. Do you bring to the position of Secretary any direct
experience in the challenges facing the Indian health care delivery
system?
Answer 1b. Yes. In the State of Kansas, we have the White Cloud
Indian Health Station, the Horton Health Center, the Haskell Health
Center and the Hunter Health Clinic. These facilities provide service
to the Kickapoo and Potawatomi Tribes as well as other tribes receiving
services, including those getting care from the Hunter Health Clinic,
which serves an Urban Indian population.
Question 1c. How would you characterize your familiarity with the
challenges facing the Indian health care delivery system?
Answer 1c. Tribes have identified the need for resources to address
the challenge of a growing population both for those who are currently
eligible to receive services through the Indian Health Service and for
those currently seeking Federal recognition who might become eligible
for services pending Federal review or congressional action. The
American Recovery and Reinvestment Act also acknowledged that certain
needs must be addressed by providing $500 million to address Health
Information Technology activities and for the completion of two
facilities construction projects already underway, including the IHS
facility in Nome, AK. HHS and IHS consult with tribes on an annual
basis to hear from them directly about challenges they are facing. In
addition, there are several provisions in ARRA that address Medicaid
and CHIP issues to benefit those who receive services from IHS or from
programs operated by tribes or tribal organizations through self-
governance contracts and compacts.
Question 1d. How do you intend to improve your understanding of the
Indian health system and its challenges?
Answer 1d. The Department conducts ongoing consultation with tribal
governments and tribal leaders in an effort to stay abreast of the
needs of the Indian population. I want to use that consultative process
to identify ways we can improve IHS and other HHS services and make
them reflect a true partnership between the Department and Native
communities. Dr. Yvette Roubideaux, the President's nominee for IHS
Director, will also help me understand new ways to serve the American
Indian/Alaska Native population. My experience in Kansas will certainly
help, and I hope to visit IHS facilities across the country to
understand the unique challenges various communities--rural and urban--
face. I also understand the Department maintains the Intradepartmental
Council on Native American Affairs (ICNAA) as authorized by the Native
American Programs Act. The Director of the Indian Health Service co-
chairs this Council with the Commissioner of the Administration for
Native Americans. This Council serves to keep the Secretary apprised of
the implementation of current initiatives as well as those under
development that are critical to the effective service the Department
provides to both Native American individuals and those specifically
eligible to receive services from IHS and its programs.
Question 1e. The National Indian Health Board has long been of the
view that the Director of the Indian Health Service should be elevated
to an Assistant Secretary level position. Do you agree that the
position should be elevated?
Answer 1e. I understand that tribes have recommended this for many
years because of the importance of the Government-to-Government
relationship, the trust responsibility of all agencies in HHS to tribes
and their members, and their desire to have increased access to the
Secretary to make sure the needs of IHS are addressed. I plan to review
this proposal and try to find the best solution to ensure that the
health and human services needs of Native Americans are addressed at
the highest levels throughout the Department. If confirmed, IHS will be
a high priority for me, and that priority will be reflected throughout
HHS and its activities.
Question 2a. Some tribes continue to rely upon the Indian Health
Service to deliver health care to our Native people. However, many
tribes have elected to deliver the healthcare themselves under Indian
Self Determination Act compacts and contracts. This is how Indian
health care is delivered in Alaska. Self determination and self
governance tribes have long been concerned that the amount of money
that the Indian Health Service budgets to pay Contract Support Costs is
grossly inadequate to meet its obligations to the tribes.
In your judgment, is this concern justified?
Answer 2a. Contract Support Costs (CSC) are essential to a self-
governance tribe's ability to effectively operate a program assumed
under the ISDEAA. Pre-award costs, start-up costs, direct and indirect
CSC all require a level of funding adequate to meet the needs of this
program. If confirmed, I will work to ensure that adequate funding is
available and that competing priorities within IHS and tribally
operated programs are not compromised.
Question 2b. How does the deficiency in Contract Support Cost funds
affect the access to and quality of health care delivered to our Native
people by contractors and compactors?
Answer 2b. To the degree that there are deficiencies in the CSC
funds, if confirmed, I will support the IHS's continued consultation
and participation with tribes to identify the best means of
administering and allocating CSC funds. Consideration of access and
quality health care must be first and foremost in the determination of
sound CSC allocation policies.
Question 2c. How would you suggest that the Federal Government as
well as the compactors and contractors address the Contract Support
Cost shortfall?
Answer 2c. Continued consultation with Tribes is essential to
determining the level of need in this program area. Certainly, lines of
communication must be open. In addition, IHS must review its allocation
policies to ensure that funding for CSCs are reasonable and necessary.
Finally, it is crucial for Congress to work with the President and the
Secretary to support increased funding.
Question 3. The American Indian and Alaska Native community has
long believed that funding for the Indian Health Service is grossly
inadequate. Senator Daschle was fond of reminding the Senate that
America spends substantially more for the care of each Federal prisoner
than it does for the care of each Indian. My colleague, Senator Dorgan,
and I frequently speak to this issue on the floor of the U.S. Senate.
Do you share our concern that the Indian healthcare delivery system is
grossly underfunded and how would you intend to address this issue if
you are confirmed?
Answer 3. I share that concern and applaud you, Senator Dorgan and
Senator Daschle, for bringing this serious issue to the attention of
your colleagues and the American people. The Indian Health Service
meets less than 60 percent of the healthcare needs of this population.
The current funding levels have not kept up with inflation, population
growth, and the rising cost of medical services. As a result, IHS must
grapple with rationing of needed healthcare services, a lack of
infrastructure for health IT expansion, and an inability to maintain
healthcare facilities. Notably, the IHS Federal Health Disparity Index
study estimates that to fully fund the clinical and wraparound service
needs of the Indian health care system, the IHS budget would need an
additional $15 billion.
If confirmed, I plan to work closely with Congress to find ways to
increase the IHS budget so we can meet the healthcare needs of our
First Americans. I recognize the challenges of finding this funding
while our Nation deals with the economy and other issues, but I would
like to make improving the IHS a priority during my term should I be
confirmed.
Question 4. A few of my colleagues have been working together to
resolve issues regarding the Indian 477 Employment and Training
program. Through the program, American Indian Tribes are able to
integrate their employment and training programs that they receive from
the Department of Interior, the Department of Health and Human
Services, and the Department of Labor. The 477 program enables tribes
to integrate their employment programs, and reduce burdensome and
redundant regulatory requirements. The spirit of the 477 program
enables tribes to submit a single plan, single report, and single audit
to the Department of Interior. Interior administers the programs. I
want to take this opportunity to make you aware that over the last few
years, the HHS has been attempting to pull out of the program over
concerns regarding the contract mechanism the Department of Interior
uses to deliver the funding, the budget and audit procedures that
Interior uses, and the sharing of information between agencies. The
program in particular controversy has been the TANF program at HHS. In
the last Congress, my colleagues (Baucus, Dorgan, Cantwell, and
Murkowski), and I mediated between the agencies, and encouraged the two
departments, to work with OMB in resolving the concerns, with the goal
to keep the 477 program intact. I wanted to ensure that during the
Senate confirmation process that you are aware of this issue. Will you
be able to provide me with an update on the status of negations with
OMB and be willing to work to the fullest extent possible that HHS
remains a committed and viable partner in the 477 program?
Answer 4. Thank your for bringing this to my attention. I am
committed to supporting tribal employment and training programs. My
understanding is that progress has been made in the discussions with
the Department of the Interior and HHS, with OMB's assistance and that
the Tribal TANF program has continued the tribes' participation in the
477 program. If confirmed, I will explore this issue in more depth and
work to the fullest extent possible with Interior and OMB to resolve
any outstanding issues with the Tribal TANF and 477 program. Toward
that end, I will appreciate your input.
QUESTIONS OF SENATOR COBURN
Question 1. Which programs within the Department, if any, do you
think can be eliminated because they are ineffective, duplicative,
unnecessary, or have outlived their purpose?
Answer 1. President Obama has announced his plan to conduct a
comprehensive, in-depth review of the various programs and policies at
the Federal agencies. While we believe it is premature to announce a
series of programs that should be eliminated ahead of that process,
there are already initiatives that the President has stated should be
cut. For example, Medicare Advantage overpayments are an area where we
can make cuts, given the current budget realities.
Question 2. President Obama promised to conduct ``an immediate and
periodic public inventory of administrative offices and functions and
require agency leaders to work together to root out redundancy.'' When
do you plan to start this and when can we expect you to complete it?
Answer 2. As Governor, I have made it a high priority to ensure
that taxpayer dollars are used efficiently and effectively. I directed
the consolidation of our health agencies in Kansas, reducing
bureaucracy and improving performance. I created a Fraud Squad that
recovered $7.5 million during my term. If confirmed, I will bring this
same energy to running the Department of Health and Human Services, and
I fully intend to work on improving the Department's performance every
day that I am Secretary.
Question 3. President Obama has often pledged to conduct Government
affairs with an unprecedented level of transparency. Currently all
recipients of Federal grants, contracts, and loans are required to be
posted online for public review. Do you support making all Federal
assistance including subcontracts and subgrants transparent in the same
manner? Will you comply on a timely basis with the Transparency and
Accountability Act?
Answer 3. I do support the President's commitment to maximizing
transparency in the Federal grant, contract, and loan process. If
confirmed, I will help implement nearly 20 percent of the American
Recovery and Reinvestment Act. The President directed that this
critical funding be implemented with unprecedented levels of
accountability and transparency. I also believe that transparency will
improve the performance of the U.S. health system as a whole, as well
as the individual programs I will oversee if I am confirmed as
Secretary of HHS. I will examine the current scope and mechanism for
public posting of such information and work to address any gaps that
exist.
Question 4. A Federal court recently unilaterally determined that
girls under the age of 18 should have unrestricted, over-the-counter
access to Plan B--also known as ``the morning after pill''--overruling
FDA's decision to require that minors first obtain a valid prescription
for the potentially dangerous drug. In my practice, I need to obtain
parental consent before prescribing medicine to a minor, and in many
areas minors can't even buy cough medicine over the counter. Will you
appeal this decision to prevent minors from having unfettered access to
a potentially harmful drug without a prescription or parental consent?&
Answer 4. I intend to look at the Court's decision closely and
consult with experts at FDA and the Department before making any
decision.
Question 5. Legislation in the last Congress--which would have
authorized FDA approval follow-on versions of biologic therapies--
contained a provision which should concern anyone interested in patient
safety. The provision would allow the substitution of follow-on
biological products for a prescribed innovator product at the point of
dispensing, without a physician's knowledge. Can you tell me if you
agree that a biological product may be substituted for the reference
product without the intervention of the health care provider who
prescribed the reference product? Do you believe that patients deserve
the benefit of a physician's choice of treatment? Are you willing to
state that a physician may elect to prescribe a specific biologic
(follow-on or innovator) based on their own review of the clinical data
and their own clinical judgment on what is the best therapy for their
patient?
Answer 5. The President strongly supports the creation of a pathway
for the approval of follow-on biologics. Lowering costs in the
healthcare system is a critical goal of his health reform efforts.&
The current monopoly in the biologic drug market prevents safe,
lower-cost alternatives from coming to market, and keeps many necessary
drugs out of the reach of patients. The time has come for--and the
science supports--FDA authority to approve safe and more affordable
follow-on biologics.
I do believe that patients and providers should partner together to
make informed health care decisions. Yet, many experts believe that the
branded drug industry has inappropriately promoted the perception that
generic drugs are inferior in order to protect their profits at the
expense of access to affordable drugs. We must ensure that the best
decisions can be made for patients based on sound science and without
undue influence from the branded drug industry.
Question 6. CDC recommends universal HIV/AIDS testing of pregnant
women. The Kansas House Committee on Health and Human Services recently
reported out a measure to provide for universal testing for pregnant
women. This legislation has already passed the Kansas Senate. Do you
support this legislation, and will you sign it if it passes both
chambers? Will you similarly promote universal testing for pregnant
women under the Ryan White Care Act?
Answer 6. I do support this legislation and will sign it into law
if it passes both chambers.
Currently, all Ryan White HIV/AIDS programs are required to follow
the Guidelines for Prevention and Treatment of Opportunistic Infections
in HIV-Infected Adults and Adolescents, which outlines specific
recommendations for pregnant women. Therefore, it is recommended that
all pregnant women undergo routine HIV testing, and that those who test
positive receive appropriate treatment.
I support universal testing for the following reasons: (1) it de-
stigmatizes HIV/AIDS in the overall context of health care; (2) it
ensures that HIV testing becomes a normal part of the health care
continuum; and (3) it is preventive, by helping to reduce the rate of
HIV transmission.
Question 7. In 2006, the Centers for Disease Control and Prevention
(CDC) released recommendations for HIV/AIDS testing. They recommend,
among other things, ``routine voluntary HIV screening as a normal part
of medical practice, similar to screening for other treatable
conditions.'' Given that hundreds of thousands of Americans with HIV
remain untested, and that this group is responsible for the majority of
new HIV infections, will you commit to promoting CDC's recommendation
to increase testing for undiagnosed HIV/AIDS patients?
Answer 7. I support the CDC's recommendation to increase testing
for all patients and, if confirmed, I will work to promote this
practice.
Question 8. Medicare spending has surged by 59 percent over the
past 5 years alone to more than $432 billion a year. Over the next
decade, the Congressional Budget Office projects that Medicaid will
expand by 8 percent annually. The Medicare Trustees' Annual Report
released earlier this year projects Medicare's excess costs to be $85.6
trillion--six times the U.S. economy in 2007. The trustees also
estimate that Medicare's long-term unfunded obligation--the benefits
promised but unpaid for--will amount to more than $36 trillion--every
American household's share of Medicare's unfunded obligation is like a
$320,000 IOU. What are your plans to address this threat to our
economic security and our children's heritage? Shouldn't we address the
current entitlement crisis before even talking about expanding our
entitlement programs?
Answer 8. Everyone agrees that Medicare faces a serious long-term
financing problem that must be addressed. But the most serious
challenge facing Medicare is skyrocketing costs in the health care
system as a whole. Addressing the causes of these system-wide costs is
the key to addressing Medicare's long-term financing. We must also
address existing Medicare policies that exacerbate the problem, such as
Medicare's current practice of paying private insurance companies an
average of 13 percent more than it costs to treat the same
beneficiaries under traditional Medicare--overpayments that will cost
taxpayers more than $150 billion over 10 years according to the
Congressional Budget Office (CBO).&
The real driver of costs in our health care system--and in Medicare
and Medicaid--is that we have an outdated system of health delivery, a
population of 45 million uninsured individuals that results in cost
shifting, and a lack of investment in prevention and chronic care
management. Medicare and Medicaid have performed as well as, if not
better than, private insurers on cost. Their growth rates are
comparable and payment rates lower than those of the private sector.
That said, it is a top priority to modernize these programs to make
them leaders in quality and efficiency.
Question 9. Both the NIH and the CDC have broad general authorities
to do research and public health work on virtually any disease, and to
do so in a scientifically sound manner. I believe that disease-specific
legislation that directs work at the NIH or the CDC puts politicians in
the role of playing politics with patients' lives. As you take over the
leadership of NIH and CDC, will you join me in opposing disease-
specific legislation? Would you agree that rather than pursue a silo-ed
approach of funding individual programs for the myriad of diseases and
conditions, that we should instead provide CDC and NIH with the
necessary flexibility and hold the agency accountable for results?
Answer 9. I believe that every bill should be evaluated on its own
merits. Yet, biomedical research priorities should be established on
the basis of public health need and scientific opportunity; the
intrusion of politics into this mix can seriously disrupt the process.
Decisionmakers at NIH already seek advice from many sources when
setting research priorities, including: (1) the scientific community,
including both individual researchers and professional societies; (2)
patient organizations and voluntary health associations; (3) Institute
and Center Advisory Councils; (4) Congress and the Administration; (5)
the Advisory Committee to the NIH Director (ACD); (6) the NIH
Director's Council of Public Representatives (COPR); and (7) NIH staff.
The NIH builds its budget by evaluating those current opportunities
and public health needs while maintaining strong support for
investigator-initiated research. The formulation of the NIH budget
provides an established framework within which priorities are
identified, reviewed, and justified.
To assist the scientific assessment of research priorities, The NIH
Reform Act of 2006 established the Division of Program Coordination,
Planning, and Strategic Initiatives (DPCPSI) at NIH. This office
identifies important areas of emerging scientific opportunity or rising
public health challenges to assist in the acceleration of research
investments in these areas.
Question 10. Is there any constitutional authority for Congress to
impose a mandate on any American citizen to purchase a private
commodity such as health insurance? Please cite it, if so. Is there any
precedent in public policy at the Federal level for the imposition of a
mandate on American citizens to buy a private good or service? If you
support an individual mandate, what enforcement mechanisms would you
propose?
Answer 10. I share the President's belief that every American
should have affordable, high-quality health care coverage. Making
health insurance affordable is the key to covering everyone. We intend
to do all we can, working with Congress and through executive action,
to lower the cost of health care in America. There are many ideas in
Congress and in the country on how to cover all Americans and, if
confirmed, I look forward to working with you to finally achieve this
critical goal.
QUESTIONS OF SENATOR BURR
FDA
Question 1. You noted in your testimony the importance of FDA and
strengthening the agency. I understand that deadlines for new drug
approvals at FDA have slipped dramatically in the past year. How will
you ensure that FDA is meeting statutory requirements to keep the drug
approval pipeline open in a manner that Congress has directed?
Additionally, do you believe that the FDA needs new regulatory
authority to monitor the safety of our food supply in a more robust
manner? Senators Durbin, Gregg and I have introduced an important food
safety bill. Is passage of effective and bipartisan food safety
legislation a priority of yours?
Answer 1. The FDA is currently hiring additional drug reviewers
with the new resources provided by the Food and Drug Administration
Amendments Act. Once hired and trained, these new staff will help the
agency meet its drug review commitments.
I do believe that the FDA needs new regulatory authorities to
enhance our Nation's food safety systems and, if confirmed as
Secretary, I look forward to working with FDA and Congress on food
safety legislation. Food safety is a priority shared by both the
Administration and Congress.
Question 2. Last, recent U.S. Supreme Court cases have highlighted
the critical importance for FDA to effectively evaluate pharmaceuticals
and medical devices, inform clinicians of their appropriate use, and
provide adequate safety information to patients to make an informed
decision about their use in treatment. Do you believe FDA should take a
more proactive approach with the industry to improve drug labeling and
device safety information? Do you believe our legal system adequately
and efficiently compensates patients for injuries resulting from a drug
or medical device?&
Answer 2. FDA should proactively engage with industry to ensure
that health care practitioners and patients receive the information
they need to make informed decisions about drugs and devices. In
addition, other safeguards should be in place to reduce the likelihood
of harm from drugs and medical devices. I am interested in hearing any
thoughts and ideas you and others may have on how the legal system can
be improved in this area.
CDC
Question 3. In your statement, you discussed the importance of
ensuring CDC is focused on the prevention of disease. I couldn't agree
with you more, and I look forward to working with you to revitalize and
strengthen CDC to meet the important goals of health promotion and
disease prevention in an open, transparent way. Along those lines, I
welcome your thoughts on whether you believe CDC has a transparent
priority-setting process that is accessible to the public? Are you
satisfied with the scientific criteria used to allocate resources and
set priorities at CDC, based on disease burden or some other criteria?
If not, what would you do as Secretary to better align priorities and
resources with science?&
Answer 3. The initial allocation of CDC resources begins with the
annual appropriations bills, which include a detailed assignment of
resources within the agency. CDC is faithful to congressional intent
with regard to allocation of resources. Within the individual funding
allocations, CDC uses science as a basis to further allocate resources.
More can be done to add transparency to the way in which CDC
allocates resources. CDC has developed a research agenda to drive its
activities, and that agenda has been subject to broad public
consideration and engagement. Additionally, each of CDC's primary
program areas is advised publicly by Boards of Scientific Counselors.
Notably, CDC's National Institute for Occupational Safety and
Health (NIOSH) has, since 1996, implemented a robust public and
professional engagement strategy to inform and develop its National
Occupational Research Agenda. Given the burden of chronic and
environmental disease along with injury, both Congress and the
Administration can do a better job of highlighting the economic and
disease burdens that are posed in these areas. While CDC needs to
deploy the best science possible, it also needs to continue to support
emerging and less quantifiable threats, both natural and manmade.
Question 4. Last, CDC under-went a major reorganization in the last
few years, called the Futures Initiative. The goals of this
reorganization were to facilitate agency-wide coordination, achieve a
measurable impact on the Nation's health, increase effectiveness and
accountability for the services provided, expand partnership
opportunities, and enhance the ability to respond to public health
emergencies. From your perspective, what has been the impact--both
positive and negative--of this reorganization?
Answer 4. The reorganization allowed the agency to focus on better
integrating its diverse programs. The integration was focused both
within and across program areas. There was also a renewed emphasis on
developing measurement tools and focusing on achieving tangible health
impact--in both the short and long terms. One particularly positive
outcome of the reorganization was a renewed realization of the
underlying strengths of the organization and a renewed resilience.
At the same time, reorganizations are difficult and place stress on
institutions and individuals, and it is my understanding that this was
the case here. The reorganization occurred during a period in which
numerous external events (e.g., avian flu, SARS, and budgetary strains)
were affecting the agency's ability to function normally.
I believe CDC must constantly evolve to deal with the challenges it
will inevitably face. Ultimately, the agency must strive to keep its
focus on positively impacting the health of Americans and people around
the globe.
Question 5a. I am sure you are familiar with the conclusions of the
World at Risk Report recently released by the bipartisan WMD
Commission, including the finding that terrorists are more likely to be
able to obtain and use a biological weapon than a nuclear weapon and,
therefore, the U.S. Government should make bioterrorism a higher
priority.
Do you agree that a bioterrorist attack remains at or near the top
of our Nation's most serious threats?
Answer 5a. Yes.
Question 5b. What efforts does HHS plan to pursue to address and
communicate that threat to Congress and State and local officials?
Answer 5b. HHS has supported DHS's risk and net-assessment efforts
and will assist in whatever ways are necessary to communicate with the
Congress, State, and local authorities regarding those efforts and
other appropriate medical and public health solutions that are needed
to counter the threat. Additionally, the Office of the Assistant
Secretary for Preparedness and Response (ASPR) at HHS has sponsored
stakeholder workshops and invited presentations at emergency
preparedness and other scientific meetings to discuss the anthrax
threat and countermeasure activities.
Question 5c. Does HHS plan any new or enhanced initiatives based on
the Commission's findings?
Answer 5c. In August 2008, President Bush submitted a supplemental
budget request totaling $905 million to initiate efforts for medical
countermeasure advanced development and dispensing in the United
States, focused primarily on anthrax. To date, no appropriation has
been provided based upon this request.
Within the existing budget, HHS will continue its efforts to
develop, stockpile, and build manufacturing infrastructure for new
anthrax vaccines, antitoxins, and antibiotics, including antibiotic
MedKits for responder populations. These efforts will focus on the
development of next generation broad-spectrum antibiotics to treat
illness against enhanced anthrax agents that are antibiotic-drug
resistant, and on working with the Department of Defense to establish
new public-private centers of excellence for countermeasure
development/manufacturing in the United States against biological
threats, including anthrax.
PH Preparedness
Question 6. As you know, HHS is tasked with preparing for and
responding to public health emergencies. How well prepared do you think
the Nation is for a public health emergency, such as a bioterrorist
attack or pandemic flu outbreak? Have you been able to assess the
department's internal capabilities to respond to such an attack? Does
the Obama administration intend to continue the Federal commitment
toward public health preparedness and biodefense?
Answer 6. Considerable progress has been made in recent years
toward better protecting the country from all manner of disasters,
including both natural events and the threat of terrorism. Working with
other partners in Government, including the Department of Homeland
Security, HHS has developed a series of plans and policies for
response. Through grants to States and localities, HHS has built
infrastructure for preparedness and response, trained and equipped
front-line responders, and developed better systems for communication
before and during a crisis. However, we are far from the level of
preparedness that we seek. Major gaps remain in many critical areas,
including surge capacity for mass medical/casualty care, rapid disease
detection, and food safety. The current Federal structure for public
health emergency preparedness has several specific problems. Major
limitations include: lack of strong leadership; understaffing; and
inadequate coordination within and across Federal agencies. This can
and must be improved.
Moreover, preparedness is a dynamic process that requires constant
attention and sustained investment. Sadly, much of what has been
accomplished in terms of building preparedness and response capacity is
now at risk due to budget cuts and the economic crisis. Successful
preparedness depends on vigilance, planning, and practice. If confirmed
as Secretary of HHS, I intend to focus early and consistently on these
issues. I will swiftly put in place an expert, experienced team to lead
HHS disaster preparedness and response efforts. We will work closely
with our partners at all levels of government, and with the private and
not-for-profit sectors to ensure we have robust, clear, and well-
established preparedness plans. This will include direct participation
in drills and exercises to ensure full understanding of the
complexities of the various potential scenarios, the level of
preparedness for differing contingencies, and the critical areas for
further work and development.
BARDA
Question 7. Senator Kennedy and I advocated for the creation of the
Biomedical Advanced Research and Development Authority--known as
BARDA--at HHS to speed up the development of more and better medical
countermeasures to protect the American people. However, BARDA can only
be successful if it is adequately funded. We authorized $1 billion for
BARDA over 2 years, but much of that has not been appropriated. I am
worried that our window of opportunity for persuading the private
sector to invest in these needed drugs and vaccines is quickly closing.
Will you advocate for funding BARDA at the level necessary to prepare
our country to respond to a bioterror attack or pandemic?
Answer 7. Adequate preparedness depends on having access to the
necessary medical countermeasures to protect health and control
disease. Our current supply of medical countermeasures to respond to
the array of potential biological threats before us is limited,
compromising both health and national security. We know that market
forces alone are not sufficient to engage the pharmaceutical industry
to address these needs. HHS must provide leadership and spearhead a
robust effort to ensure development and availability of new, more
effective and accessible drugs, vaccines, and diagnostics to enable
rapid identification and response to biological threats, whether those
threats are the result of natural causes or bioterrorism. The
Biomedical Advanced Development Research and Development Authority
(BARDA), working in partnership with the private sector and NIH, can
serve as a critical bridge, helping to take the promising discoveries
through all the stages of product development and manufacture.
Investment in medical countermeasure development and procurement
represents a national security priority, a major public good, and a
potential economic driver--both through job creation and through the
benefits of reduced disease burden.
To enable success in its advanced development mission, we must fund
BARDA adequately. Importantly, if we do not commit to increased BARDA
funding, there is a risk that biopharma firms will lose confidence in
the U.S. Government's commitment to an inclusive approach to
biodefense.
Funding at the originally intended levels would also empower BARDA
to fulfill its statutory ``innovation'' mission, and enable BARDA to
support development of new, lower-cost, and more accessible medicines
and vaccines for biodefense needs, infectious diseases in the
developing world, and emerging pathogens.
Medicare
Question 8. Since more than 70 percent of all new cancer diagnoses
occur in the elderly population, CMS would have a strong desire to get
more Medicare recipients in for regular screenings, particularly for
the most curable cancers like colon cancer. Will you work with the
President and Congress to ensure that CMS provides Medicare recipients
with access to reliable screening tools, such as CT Colonography, so
that we can improve patient outcomes?
Answer 8. I share the view that Medicare should promote greater
preventive care to ensure that chronic and acute conditions can be
effectively managed--or prevented altogether--to improve the quality of
life for Medicare beneficiaries and to avoid or delay very expensive
hospital stays. As we consider adding new preventive benefits to
Medicare, we should ensure that these decisions are based on sound
medical evidence. Such criteria will ensure that Medicare beneficiaries
and their physicians can establish the best treatments of care and that
Medicare's financial resources are most wisely spent.
Medical Home
Question 9. Senator Durbin and I plan on introducing legislation in
April that would establish eight medical home demonstration projects
across the United States under the Medicaid and SCHIP programs. If
these projects achieve the level of success that has been achieved by
NC's Medicaid medical home program, Community Care (approximately $200
million/year savings), the benefit to Americans' health and to our
fiscal bottom line would be significant. Would you be supportive of
implementing some medical home demonstration programs around the United
States?
Answer 9. The medical home model is an effective way to provide
continuous, coordinated high-quality care to patients, and achieve
better outcomes, reduced disparities, and lower costs. The Medicare
program has initiated a medical home demonstration program that may
well merit expansion to additional sites and beneficiaries. Similarly,
we will explore expanded testing of this model in other public
programs, including Medicaid and SCHIP. Medical homes are an important
element of policies to improve quality of care for people as we reduce
costs.
QUESTIONS OF SENATOR ALEXANDER
Head Start/Early Education
Question 1. I am author of the Centers of Excellence program in the
Head Start Act and am pleased that the fiscal year 2009 omnibus secured
funding for this program. The Centers would serve an important role in
the incoming Administration's efforts on improving and expanding early
childhood education. Not only do they highlight the best programs in
each State, but they also highlight those that are best coordinating
with other similar programs--Federal, State and local. It is my hope
that you will look to the Centers of Excellence when discussing
priorities in early childhood education with President-elect Obama and
the Secretary of Education, Arne Duncan. What strategies do you intend
to pursue to improve the coordination of the dozens of existing Federal
programs dealing with early childhood education?
Answer 1. Thank you for your leadership in the reauthorization of
Head Start, and for your tireless efforts to assure high-quality early
childhood education. President Obama has made it a priority in his
budget to encourage States to raise the quality of their early learning
programs, work to ensure a seamless delivery of services, and ensure
that children are prepared for success when they reach kindergarten.
I am interested in your ideas about how we can better implement the
Centers of Excellence provisions and address coordination in the Head
Start Act. If confirmed, I look forward to working with you to explore
this and other initiatives designed to improve the quality of our
existing early childhood education programs.
Question 2. The Head Start Act requires States to create advisory
councils to better plan and coordinate the delivery of education and
health services to young children, including better connecting Head
Start, child care, pre-k, and the K-12 systems. What role do you see
the State Advisory Councils playing to improve the delivery of early
childhood services?
Answer 2. I believe State Advisory Councils and similar
coordinating structures are valuable tools that can help States find
creative and effective mechanisms to coordinate early childhood
programs funded by multiple sources. Indeed, as Governor of Kansas, I
established an Early Learning Council to accomplish this goal, and I
believe this kind of approach can be successful in other States.
Question 3. Historically early learning at the Federal level has
been exclusively under the jurisdiction of HHS. But at the State level,
early learning is often focused on State preschool, which is frequently
run by State education agencies. As Secretary, how would you work with
other agencies, particularly the U.S. Department of Education, to
improve the coordination and delivery of services to children under the
age of 5?
Answer 3. If confirmed as Secretary of HHS, I plan to work very
closely with Secretary Duncan to coordinate early learning programs in
HHS and Education more effectively. As a Governor, I learned that
collaboration between child care, Head Start, and education agencies is
essential to achieving the objectives we are seeking for young children
and their families. With that in mind, I intend to do everything I can
to improve collaboration at the Federal level on early childhood
education programs.
Question 4. During the 110th Congress, the Head Start Act was
reauthorized and the revised Act improves quality, including increased
training and education for teachers; expands access; and strengthens
accountability in the program. Do you anticipate promulgating
regulations to implement these important revisions during the first 6
months of your tenure as Secretary of Health and Human Services?
Answer 4. I applaud Congress for enacting a very important
reauthorization of the Head Start program, and I am very excited about
the prospect of working to implement key elements of this legislation.
In particular, I am interested in leveraging all the assets and tools
available to HHS to find ways to improve results for Head Start
children. If confirmed, I will carefully review the status of needed
regulations and work to promulgate them as expeditiously as possible.
Question 5. The new Head Start law allows for Head Start grantees
to convert preschool slots to Early Head Start slots based on community
need. The law specified that the Secretary would promulgate procedures
for slots conversion within 1 year of enactment, before December 12,
2008. Would you develop procedures for conversion immediately, so that
grantees could begin to serve additional infants and toddlers in Early
Head Start?
Answer 5. These provisions included in the Head Start Act were a
significant and important improvement for communities served by the
program. If confirmed, I will carefully review the status of all Head
Start regulations, particularly in circumstances where HHS has failed
to meet statutorily mandated deadlines. I will advance promulgation of
needed regulations as expeditiously as possible.
[Whereupon, at 12:32 p.m., the hearing was adjourned.]