[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

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions


      Available via the World Wide Web: http://www.gpo.gov/fdsys/




                  U.S. GOVERNMENT PRINTING OFFICE
48-540                    WASHINGTON : 2010
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing Office, 
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202ï¿½09512ï¿½091800, or 866ï¿½09512ï¿½091800 (toll-free). E-mail, [email protected].  


          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.]

                                   

      
