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48–540 PDF 2010

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/ 

COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS 

EDWARD M. KENNEDY, Massachusetts, Chairman 

CHRISTOPHER J. DODD, Connecticut 

TOM HARKIN, Iowa 

BARBARA A. MIKULSKI, Maryland 

JEFF BINGAMAN, New Mexico 

PATTY MURRAY, Washington 

JACK REED, Rhode Island 

BERNARD SANDERS (I), Vermont 

SHERROD BROWN, Ohio 

ROBERT P. CASEY, JR., Pennsylvania 

KAY R. HAGAN, North Carolina 

JEFF MERKLEY, Oregon 

MICHAEL B. ENZI, Wyoming 

JUDD GREGG, New Hampshire 

LAMAR ALEXANDER, Tennessee 

RICHARD BURR, North Carolina 

JOHNNY ISAKSON, Georgia 

JOHN MCCAIN, Arizona 

ORRIN G. HATCH, Utah 

LISA MURKOWSKI, Alaska 

TOM COBURN, M.D., Oklahoma 

PAT ROBERTS, Kansas 

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) 

(1) 

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 

2 

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. 

3 

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. 

4 

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. 

5 

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. 

6 

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 fatherin-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. 

7 

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 fatherin-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. 

8 

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 

9 

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. 

10 

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 

11 

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. 

12 

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 

13 

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 adVerDate Nov 24 2008 15:54 Jan 20, 2011 Jkt 000000 PO 00000 Frm 00017 Fmt 6633 Sfmt 6601 S:\DOCS\48540.TXT DENISE
14 

dressed 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. 

15 

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 sciencebased 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 chalVerDate Nov 24 2008 15:54 Jan 20, 2011 Jkt 000000 PO 00000 Frm 00019 Fmt 6633 Sfmt 6601 S:\DOCS\48540.TXT DENISE
16 

lenges 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 everevolving 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 

17 

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 patientprotection 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 ‘‘underinsured’’ 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. 

18 

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 lowincome Americans who rely on Medicaid benefits don’t lose coverage as States try 

to balance their budgets. The Recovery Act prevents an already-bleak healthcoverage 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 sickcare 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. 

19 

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 21stcentury 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 

20 

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 puzVerDate Nov 24 2008 15:54 Jan 20, 2011 Jkt 000000 PO 00000 Frm 00024 Fmt 6633 Sfmt 6601 S:\DOCS\48540.TXT DENISE
21 

zle—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 

22 

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. 

23 

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 

24 

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, 

25 

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. 

26 

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 longterm 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 

27 

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 

28 

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 

29 

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 

30 

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 

31 

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 reinvigorate 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 

32 

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 redesign 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 

33 

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 longterm, 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? 

34 

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. Compara- tive 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 

35 

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 highquality care and value are inadequate in many parts of the country 

despite $2 trillion in annual health care spending? 

36 

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. 

37 

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 

38 

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. 

39 

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? 

40 

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 Medicareeligible 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. 

41 

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 

42 

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. 

43 

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 

44 

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 dolVerDate Nov 24 2008 15:54 Jan 20, 2011 Jkt 000000 PO 00000 Frm 00048 Fmt 6633 Sfmt 6601 S:\DOCS\48540.TXT DENISE
45 

lars, 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. 

46 

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 

47 

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 decisionmaker. 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? 

48 

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, 

49 

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. 

50 

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. 

51 

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. 

52 

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.] 

53 

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 

54 

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 

55 

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 

56 

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 antiVerDate Nov 24 2008 15:54 Jan 20, 2011 Jkt 000000 PO 00000 Frm 00060 Fmt 6633 Sfmt 6621 S:\DOCS\48540.TXT DENISE
57 

biotics, 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. 

58 

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? 

59 

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. 

60 

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 welltrained 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 

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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 11⁄2 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 Methicillinresistant 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. 

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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 centralline 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 NurseFamily 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 beVerDate Nov 24 2008 15:54 Jan 20, 2011 Jkt 000000 PO 00000 Frm 00066 Fmt 6633 Sfmt 6621 S:\DOCS\48540.TXT DENISE
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tween $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. 

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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 pharmacistprovided 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. 

65 

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 creVerDate Nov 24 2008 15:54 Jan 20, 2011 Jkt 000000 PO 00000 Frm 00069 Fmt 6633 Sfmt 6621 S:\DOCS\48540.TXT DENISE
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ating 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. 

67 

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? 

68 

Answer 20. Many universities have been developing or refining their own conflictof-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 

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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. 

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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-birthweight 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 

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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 

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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 

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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. 

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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 mediVerDate Nov 24 2008 15:54 Jan 20, 2011 Jkt 000000 PO 00000 Frm 00078 Fmt 6633 Sfmt 6621 S:\DOCS\48540.TXT DENISE
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cally 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? 

76 

Answer 3. The Federal Government can play an important role in promoting highquality 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 

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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 

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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? 

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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 highquality 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 

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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. 

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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 Governmentrun 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 

82 

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? 

83 

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 imporVerDate Nov 24 2008 15:54 Jan 20, 2011 Jkt 000000 PO 00000 Frm 00087 Fmt 6633 Sfmt 6621 S:\DOCS\48540.TXT DENISE
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tant 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. 

85 

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 

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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. 

87 

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 earVerDate Nov 24 2008 15:54 Jan 20, 2011 Jkt 000000 PO 00000 Frm 00091 Fmt 6633 Sfmt 6621 S:\DOCS\48540.TXT DENISE
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lier, 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. 

89 

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? 

90 

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 

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(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 

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parable 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 

93 

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. 

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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 re- quest 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 

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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 

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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? 

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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.] 

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