[Senate Hearing 109-56]
[From the U.S. Government Publishing Office]
S. Hrg. 109-56
NOMINATION OF MICHAEL O. LEAVITT
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
ON
MICHAEL O. LEAVITT, OF UTAH, TO BE SECRETARY, DEPARTMENT OF HEALTH AND
HUMAN SERVICES
__________
JANUARY 18, 2005
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
MICHAEL B. ENZI, Wyoming, Chairman
JUDD GREGG, New Hampshire EDWARD M. KENNEDY, Massachusetts
BILL FRIST, Tennessee CHRISTOPHER J. DODD, Connecticut
LAMAR ALEXANDER, Tennessee TOM HARKIN, Iowa
RICHARD BURR, North Carolina BARBARA A. MIKULSKI, Maryland
JOHNNY ISAKSON, Georgia JAMES M. JEFFORDS (I), Vermont
MIKE DeWINE, Ohio JEFF BINGAMAN, New Mexico
JOHN ENSIGN, Nevada PATTY MURRAY, Washington
ORRIN G. HATCH, Utah JACK REED, Rhode Island
JEFF SESSIONS, Alabama HILLARY RODHAM CLINTON, New York
PAT ROBERTS, Kansas
Katherine Brunett McGuire, Staff Director
J. Michael Myers, Minority Staff Director and Chief Counsel
(ii)
C O N T E N T S
__________
STATEMENTS
Tuesday, January 18, 2005
Page
Enzi, Hon. Michael B., a U.S. Senator from the State of Wyoming.. 1
Kennedy, Hon. Edward M., a U.S. Senator from the State of
Massachusetts.................................................. 3
Hatch, Hon. Orrin G., a U.S. Senator from the State of Utah...... 4
Frist, Hon. Bill, a U.S. Senator from the State of Tennessee..... 5
Bennett, Hon. Robert F., a U.S. Senator from the State of Utah... 7
Leavitt, Michael O., Governor of Utah, nominated to be Secretary,
U.S. Department of Health and Human Services, opening statement 22
Prepared statement........................................... 25
Burr, Richard, a U.S. Senator from the State of North Carolina... 34
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Letters of support from various organizations and Governors.. 9
Questions of the Safe Food Coalition for Governor Leavitt.... 21
Response to questions of Senator Bingaman.................... 53
Response to questions of Senator Clinton..................... 61
Response to questions of Senator Dodd........................ 69
Response to questions of Senator Harkin...................... 73
Response to questions of Senator Jeffords.................... 76
Response to questions of Senator Kennedy..................... 76
Response to questions of Senator Mikulski.................... 86
Response to questions of Senator Murray...................... 87
Response to questions of Senator Reed........................ 90
(iii)
NOMINATION OF MICHAEL O. LEAVITT
----------
TUESDAY, JANUARY 18, 2005
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The committee met, pursuant to notice, at 10:03 a.m., in
room SD-106, Dirksen Senate Office Building, Senator Enzi
(chairman of the committee) presiding.
Present: Senators Enzi, Gregg, Frist, Alexander, Burr,
Isakson, Hatch, Kennedy, and Dodd.
Opening Statement of Senator Enzi
The Chairman. I will call the hearing to order. Good
morning and welcome to today's hearing on the nomination of
Michael Leavitt to serve as the Secretary of Health and Human
Services. It is my pleasure to welcome the former Governor, now
Secretary Leavitt, and all those in attendance. I want to thank
Governor Leavitt--I have had more contact with him as Governor
than I have as Administrator, and I really appreciated the
effort that he did in our neighboring State of Utah. And I want
to thank him for his willingness to serve in this capacity. I
know that you have been through nomination hearings for your
previous job, and now to go through a second one is very much
appreciated. And this one there will actually be two hearings
on because the committee of final jurisdiction on it is the
Finance Committee. So we are glad to have you do this extra
duty and be with us today. I have known you for a long time and
appreciate all the effort you have done. Back in my legislative
career, you were working on the Western Governors University
and did an outstanding job of putting that high-tech bit
together. And you have served as the Governor of Utah, and that
has a very rural capacity, as well as Salt Lake City. So you
come with some diverse experience that will do our Nation well.
During the President's first term, we had some important
health care reforms. Medicare reform is now on the books, an
option that will have a dramatic effect on the costs borne by
our Nation's seniors for medical care. In addition, the option
of health savings accounts has been expanded to provide seniors
and the young with an incentive to invest in these tax-free
health insurance alternatives. And, finally, more than 600
community health centers have been opened or expanded to serve
low-income and uninsured people across this country.
There is still much left to do. Fortunately, you have the
skills and the ability to help keep our health care system
responsive and our safety net intact to protect the most
vulnerable among us. It is clear from your record that you have
a great appreciation for the importance of the family unit, the
most local level from which we can address problems in this
Nation. Our families are the cornerstone of our society and the
building blocks of our communities, and it is where all of
health and human services starts.
As you work on the health care issues that affect our
families so directly, I want to assure you that Congress will
work with you. In fact, we must work together and focus on the
results if we are to keep the promises we made for the work on
health initiatives.
When you are sworn in, you will be overseeing a budget of
several hundred billion dollars and administering the operation
of more than 230 programs that affect all Americans of every
age. You will also have more people looking over your shoulder
as you work than anyone else. Since every American takes his or
her health care personally, you will have more bosses than any
other worker in the world. We need to ensure their continued
access to their family doctor, keep the treatments their doctor
prescribes available and affordable, and make sure that health
insurance companies do not forget about care as they work to
control costs.
Now, President Bush has set forth his vision for improving
health care and patient safety through better and more
widespread use of information technology. Senator Kennedy and I
share the vision, and we have already begun our discussions on
how we can help to make that a reality. I look forward to
working with you, who also has a lot of information technology
background, and Senator Kennedy and our colleagues on this
committee to bring health care information into the 21st
century. I intend to focus on bioterrorism and public health
preparedness with the help of subcommittee Chairman Burr. This
will build upon the great work this committee did last year to
pass President Bush's Project Bioshield into law. President
Bush has proposed placing a community health care center or
rural health clinic in every poor county in the United States.
Such an effort will be a key part of any effort to address the
problem of expanding access to low-cost health care to those
who lack health insurance.
I think you will find the members of this committee to be
supportive of your efforts in that matter, too. In Wyoming we
have one community health center right now. That means we have
a lot of counties that need one, but we do not have the money
to provide them because most of our counties are the size of
Connecticut. Fortunately, the unique challenges of providing
services to the areas that have great distances between them is
something that is well known to you. I am looking forward to
working with you on how we can best address that problem.
Most people are concerned about their health insurance
coverage and the cost. They want policies that are more
affordable and accessible with more options. I also believe we
can come up with creative solutions to make our medical
liability system work better for patients and providers.
And then there are the front-page issues. At the forefront
is our system of approving drugs and ensuring their safety. We
must be sure the Food and Drug Administration is able to
completely review and monitor the use of medications they
approve in a timely manner. We also need to review the flu
vaccine shortage and find out what happened and come up with a
plan that will prevent it from happening again. We have to
encourage more companies to come back to the vaccine business.
Relying on a couple of companies to produce one of the most
critical and popular vaccines is a recipe for disaster.
I do not want to get into a laundry list of all of the
issues. That is just a touch on a few of them. But there is a
lot on our mutual to-do list. I appreciate the committee's
willingness to work with you and also your volunteering to
later have some informal sessions with us. I think that will
achieve a lot. We appreciate your being here today and look
forward to working with you.
Senator Kennedy.
Opening Statement of Senator Kennedy
Senator Kennedy. Thank you very much, Mr. Chairman, and
thank you for having these hearings this morning. I want to
commend Mike Leavitt for his nomination. I look forward to
working with him as Secretary.
No domestic agency of the Federal Government has a broader
and deeper impact on the lives of the American people than the
Department of Health and Human Services. Its programs reflect
the ideals of our Nation and commitment to provide help to all
those who need our help the most. HHS comforts and helps the
elderly through Medicare and the Older Americans Act. It
nurtures the young through Head Start, CHIP, and the maternal
and child health programs. It sustains poor families through
the Temporary Assistance to Needy Families Act. It brings
health care to all in poverty through Medicaid. It offers help
and hope to patients suffering from a host of diseases through
the National Institutes of Health. And it guarantees every
American that the medicines they take are safe and effective
and the foods they eat are healthful through the Food and Drug
Administration. It protects the health of every American
against the epidemics of disease through the Centers for
Disease Control.
Mr. Leavitt brings impressive skills to this critical post.
As a former Governor, he knows how HHS works and does not work.
At EPA, he confronted health issues similar to many of those
dealt with by HHS. Everyone who knows him respects his
intelligence, his high energy, and his experience as a manager
and problem solver.
His new position will test all those skills, and he will
face an especially heavy challenge this year. Many of the most
important programs he oversees get lavish praise but little
real support. Last year, the administration was able to push
through the Congress a flawed Medicare drug bill that benefited
drug companies and insurance companies at the expense of
patients. Governor Leavitt will now have to implement that
flawed bill. Press reports say the administration intends to
block grant Medicaid and cut it deeply and to deeply cut
Medicare as well. More than 50 million of the Nation's poor
elderly, poor disabled, poor families and children depend upon
Medicaid for health care. Forty-two million senior citizens and
disabled Americans depend on Medicare. The administration's tax
cuts for the wealthy and its misguided war in Iraq has created
a catastrophic deficit, but it would be unconscionable to solve
the budget crisis by penalizing the poor and the elderly who
did nothing to create it and to ask the wealthy and powerful to
make no contribution at all.
We will continue our work this year on Head Start, the
foundation of the Federal support for the Nation's most
vulnerable children. Head Start has a 40-year track record of
success, and reauthorization this year is an opportunity to
build on that success, and to do more to open the American
dream to many more children who deserve our help. A block grant
for Head Start would be, I believe, a giant step backwards. We
cannot turn Head Start into Slow Start or No Start.
The current extension of welfare reform expires at the end
of March. Our ability to move the welfare debate forward will
require more flexibility from an administration willing to work
in good faith with Congress on this basic issue of what kind of
country we are. We are impressed with what you Governor
Leavitt, did in your State in terms of flexibility.
Other priorities facing the Department include the need to
move the health care system into the modern age, using
information technology, as the chairman has mentioned, and
improve FDA's ability to detect and respond promptly to warning
signals on the effects of new drugs. We must also continue the
fine work of Secretary Thompson of putting disease prevention
and health promotion higher on the national agenda.
So I welcome you. I was just looking over, Mr. Chairman,
the public health legislation we have in this committee's
jurisdiction the NIH, CDC, FDA, community health centers which
you mentioned, bioterrorism, Head Start, LIHEAP, the
Administration on Aging, Meals on Wheels, child care, child
protection and many of those are in your Department. We work
together with the Finance Committee, but we are very, very
grateful to you for your willingness to come here and speak to
us about not only these issues but also how you intend to lead
the Department. You are very welcome to the committee, and we
look forward to working with our Chair to make sure that we get
you into your responsibilities as soon as we can.
The Chairman. Now it is my pleasure to recognize my friend
and colleague from Utah, who has just returned to the
committee, who used to chair this committee. We appreciate all
of your efforts on all of the committees you have been on, and
we look forward to your introduction of your fellow Utahan.
STATEMENT OF HON. ORRIN G. HATCH, A U.S. SENATOR FROM THE STATE
OF UTAH
Senator Hatch. Thank you, Mr. Chairman, Senator Kennedy,
other members of the committee. It seems rather odd to be at my
first hearing back on the HELP Committee and to be on this side
of the dais. But it is for the best of purposes.
It is both Senator Bennett's and my honor and privilege to
introduce to you our good friend and fellow Utahan, Governor
Mike Leavitt, and to urge that his nomination be approved on an
expedited basis. Although his wife is not here today because of
illness, I would like to recognize his beautiful wife, Jackie;
and he has five wonderful children. And he is a wonderful
family man, and Jackie has herself assembled quite a record in
working on issues that this committee is interested in such as,
just to mention one, childhood vaccines.
I have also known Mike Leavitt for a long time and have
worked closely with him on many key issues, not only Utah
issues but national issues as well. In short, Governor Leavitt
is bright, energetic, dedicated, and fair.
Now, I say with all respect to those who have gone before
him, I can think of no better Secretary of Health and Human
Services and no better candidate for it. Mike has devoted a
considerable part of his life and time to public service, first
in our home State of Utah and, of course, more recently here in
Washington. He has proven himself to be an excellent manager, a
smart decisionmaker, a tireless worker, and a successful
executive. He has an established record of fiscal management, a
demonstrated knowledge of health care, and a solid reputation
as a decent, energetic, good family man.
His wife is a tremendous partner to him. I might mention
that she comes from a little town in northern Utah named
Newton. It used to be a town of about 300 people. That is where
my wife comes from, too. It is a very well-represented city in
Utah.
Now, an important hallmark of Mike Leavitt's service that I
wish to commend to this committee is his fairness. You can
count on him looking at all sides of an issue before making a
policy decision, and I think you can count on him making the
right decision. His record as EPA Administrator bears this out,
but also his record as head of the Governors Association. This
should also give great comfort not only to those of us in
Government, but also to the hundreds of millions of people that
HHS serves so well.
As our time is short, Mr. Chairman, I just want to leave
you with one short story. After attending several briefings
with this Secretary-designate, a senior official at the FDA
told me the other day, ``At our first briefing, Governor
Leavitt was good. At the second meeting, he was excellent. And
at the last briefing, he was teaching us.'' And that is typical
of Mike Leavitt. This is the kind of man that Mike Leavitt is.
He will be a great Secretary.
I take a great interest in this agency, always have, always
will. I think both of you have outlined how important it is to
the health and well-being of our country. And so with pride and
admiration, along with Senator Bennett, I introduce to this
committee Governor Mike Leavitt. So I would just ask of the
committee let us get him confirmed and in the job as soon as
possible because I think he will do a terrific job there.
Thank you, Mr. Chairman.
The Chairman. Thank you.
We have been joined by the Majority Leader, Senator Frist,
so unless there is objection, we will allow him to give a
statement at this time.
Opening Statement of Senator Frist
Senator Frist. Mr. Chairman, thank you, and I will be
brief.
Before we begin, let me take this opportunity to say how
much I look forward to working with our new chairman as well as
our ranking member for what I know is going to be an exciting
year and really entire Congress.
Just as an aside, it is interesting, as we went through all
of our committee assignments, that this was probably the most
popular committee for people to try to join from the Republican
side this year. I think it reflects the confidence in the
committee's leadership and our support for the issues that our
nominee today will be leading on over the next Congress.
I also just very briefly want to recognize the tremendous
leadership of Senator Gregg, who has done an outstanding job on
this committee, and as we all reflected back over the last
Congress, the tremendous strides we made on a number of issues.
To be able to walk in the door a few moments ago and see our
two members, Richard Burr of North Carolina and Johnny Isakson
of Georgia, our new members, gives me a great deal of pride. I
have had the opportunity to talk to both of them about issues
that this committee will be addressing over the course of this
Congress, and both are committed to and passionate about those
issues.
Today's hearing is vital to ensuring our commitment to
protecting the safety, health, and well-being of the American
people. I am pleased that such a strong leader, Michael
Leavitt, has been nominated by President Bush for this role. As
members of this committee know better than anybody, the
Department of Health and Human Services is the second largest
Federal Department, overseeing more than 300 programs with a
budget of $580 billion. The programs that you will oversee,
Governor Leavitt, are critical, as you well know, to the
everyday lives of every single American, and the impact will be
tremendous on future generations.
You bring, as Senator Hatch just said, considerable
experience to this post with your past positions of Governor of
Utah, Chairman of the National Governors Association, and most
recently Administrator of the EPA. Your leadership has been
steady, demonstrated in Utah, as you addressed issues that we
are so committed to on this particular committee, and that is
access to health care for children and adults and keeping
rising health care costs under control, which will be a huge
topic and focus of this committee over the next Congress. The
fact that Utah's uninsured rate remains below the Nation's
average is a goal and a standard that we should use in this
committee as we look at various policy proposals. Your
experience as host of the 2002 Olympic Winter Games and co-
chair of the National Governors Association Homeland Security
Task Force makes you an ideal candidate.
We begin this 109th Congress with a real record of
progress, having signed into law over a dozen pieces of
critical health care initiatives which touch the lives of each
American, the Medicare Modernization Act, which guarantees
Medicare beneficiaries access to more affordable medicines,
better health care choices, and higher-quality care. For the
first time we really put a demonstrable emphasis on preventive
care, and for the first time tied payments to quality of care,
doors that had been opened, but doors that we need to explore
much further in our policies in this Congress. The Project
Bioshield Act of 2003, an issue that I have worked on and we
have all worked on with the leadership of Senator Kennedy, has
been an appropriate and timely investment that we are going to
have to build upon when we look to the future and recognize one
of the greatest existential threats that the world will have to
face, this country will have to face, is the challenge of
bioterrorism. The Pediatric Research Equity Act of 2003, which
we passed last year, addressed pharmaceuticals prescribed in
children.
That is the past. We have more work to do. In addition,
issues such as the Medicare prescription drug benefit which has
been the single largest expansion of the Medicare program since
its creation, will require a lot of work with implementation by
the Centers for Medicare and Medicaid Services. We need to make
health care more affordable. We need to eliminate the huge gaps
in health care quality that we have today, and most of that
work is done by this particular committee. We need to advance
health care research, making sure that we get those discoveries
from the laboratory bench all the way to the people where they
will have their direct impact. And we must, as this committee
does first and foremost, protect and improve the public health.
I mention all that, Governor, because as a physician and as
an active member of this committee, in addition to being
Majority Leader, I am excited and enthusiastic about your
leadership. It will require bold leadership, courageous
leadership, leadership with great definition, and you are
absolutely in my mind the perfect person to provide that
leadership.
At your first inauguration, you pledged to take the State
of Utah to, and I quote, ``a whole new level of performance.''
And you succeeded. I am confident that in this new capacity you
will succeed once again. Congratulations.
The Chairman. I would like to recognize my other friend and
colleague from Utah, Senator Bennett. You have had the
opportunity to watch and work with Governor Leavitt, and I
welcome your perspective for this committee.
STATEMENT OF HON. ROBERT F. BENNETT, A U.S. SENATOR FROM THE
STATE OF UTAH
Senator Bennett. Thank you very much, Mr. Chairman. I
appreciate the opportunity.
I first met Mike Leavitt as we worked on school issues,
which used to be part of the jurisdiction of the Department of
Health, Education, and Welfare. And then we both entered the
lists of electoral politics at the same time in 1992, he for
Governor and I for Senator, and we both managed to finish
second in the State convention in the State of Utah, which
meant that we had to come from behind to win our respective
primaries, and then ultimately our respective offices.
So we have seen an awful lot of Utah together and all the
small towns and distant counties. We have heard a lot of
terrible speeches given by our opponents, brilliant speeches
given by each of us, as we have moved through this process
together, and I consider him once of my best friends and one of
the public servants I know the best.
I have a list before me prepared of all of his
accomplishments. I think the committee has the same list, and
so I will not bore you with reading them. But as I contemplated
this, my mind went back to an exchange I had here on the floor
of the U.S. Senate with Pat Moynihan. There isn't anyone I
admire more among the Senate than Pat Moynihan and his insight.
But on this particular occasion, we were on opposite sides of
the issue. The question was welfare reform. To listen to
current commentators, welfare reform was one of the crown
jewels of the Clinton administration, one of the crowning
accomplishments that occurred under President Clinton's
leadership. I remember that it took us a lot of time on the
Republican side of the aisle to convince President Clinton that
this was worthwhile, and he vetoed it twice before Dick Morris
finally told him that if he did not pass it, he would not win
the 1996 election, if he did not sign it, he would not win the
1996 election.
In that setting, we were on the floor debating welfare
reform, and you will remember that Senator Moynihan was very,
very adamantly against it. And he stood on the floor of the
Senate, and he said, ``If we pass welfare reform, we will have
a race to the bottom. Everybody will compete to see how little
they can do.''
And I had watched Governor Leavitt deal with welfare reform
in the State of Utah prior to that debate, and so I was bold
enough to stand up in the Senate and disagree with Pat Moynihan
and said, ``I think quite the contrary. If we turn
responsibility for welfare reform over to the States in the way
this bill contemplates, we will see experimentation,
innovation, and ultimately great improvement in the way welfare
is handled. I don't think we will have a race to the bottom.''
Whereupon, Senator Moynihan said, ``I agree with the Senator
from Utah that you will not have a race to the bottom in Utah,
but I guarantee we will have it in New York.''
I cite that because it demonstrates that even outside the
boundaries of the State of Utah, while Governor Leavitt was
Governor, is efforts to bring innovative and creative and
forward-looking reform to a very difficult problem were
recognized--recognized by people from different States, from
the different party, from different structure, because New York
is quite different from Utah. This is a man who has proven that
he knows how to get things done. He knows how to move in
directions that are different when it is necessary to do that,
and he knows how to reinforce established principles that need
to be reinforced when it is necessary to do that.
I commend him to the committee with full and complete
confidence that he will make an outstanding Secretary of Health
and Human Services.
The Chairman. Thank you.
Governor Leavitt, we welcome you to this meeting of the
Health, Education, Labor, and Pensions Committee. To date, the
committee has received more than 35 letters of support for your
nomination from a wide cross-section of business and advocacy
groups as well as from individuals, and I anticipate we will be
receiving more letters of support in the coming days.
I do ask unanimous consent to have the letters entered in
the record. Without objection.
[The letters follow:]
The 60 Plus Association,
Arlington, VA 22209,
January 14, 2005.
Hon. Michael B. Enzi (R-WY),
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. Kennedy (D-MA),
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Senator Enzi and Senator Kennedy: The 60 Plus Association is
pleased to announce its strongest support possible for the President's
nomination of former Utah Governor, Michael O. Leavitt, to be Secretary
of the Department of Health and Human Services (HHS).
60 Plus counts just over 5 million seniors as its base of support,
with more than 5,000 in Wyoming and some 7,500 in Massachusetts, as
well as 7,500 in Utah. 60 Plus has closely followed the compassionate
career of this dedicated public servant. President Bush could not have
chosen a more able leader than Governor Leavitt. The Governor has an
intimate working knowledge of challenges that face him at HHS from
shoring up Medicare-Medicaid and making sure the Nation's health care
delivery system continues to function as smoothly as possible.
60 Plus had hoped that Secretary Thompson would remain at the helm
of HHS but after nearly 4 decades of service to his Nation, he and Mrs.
Thompson deserve a chance to ``rest on their laurels'' if you will. 60
Plus could not have recommended a better choice to be Secretary
Thompson's successor than his fellow former Governor, Mike Leavitt.
Sincerely,
James L. Martin,
President.
______
American Association of Nurse Anesthetists,
Washington, DC 20003,
January 12, 2005.
Hon. Mike Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.
Dear Mr. Chairman and Ranking Member: On behalf of the more than
33,000 Certified Registered Nurse Anesthetists (CRNAs), who administer
more than two-thirds of the Nation's anesthetics, I encourage Members
of the Senate to confirm the President's nominee for Secretary of
Health and Human Services (HHS), Michael Leavitt.
As a three-term Governor of the State of Utah, Mr. Leavitt was
responsible for several important healthcare programs including his
State's Medicaid program, for making government services more
accessible via the internet, and for signing a proclamation proclaiming
a National Nurse Anesthetists Week. We look forward to working with Mr.
Leavitt to promote anesthesia patient safety, keep Medicare strong for
seniors, support educational funding for nurses, advance access to
quality healthcare that is affordable, and enact meaningful medical
liability reform. The Administration has been more than gracious in
extending us the open door to address issues of concern to our
profession and our patients, so that we might together improve
healthcare for Americans. I am sure that Mr. Leavitt will continue such
a relationship.
If we can ever be of service during this process, please feel to
contact Frank Purcell, Senior Director of Federal Government Affairs in
our Washington, D.C. office at (202) 484-8400.
Sincerely,
Frank T. Maziarski, CRNA, MS, CLNC,
President.
______
American Association of Neurological Surgeons,
Rolling Meadows, IL 60008.
Congress of Neurological Surgeons,
Schaumburg, IL 60173,
January 17, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Chairman Enzi and Ranking Member Kennedy: On behalf of the
American Association of Neurological Surgeons and the Congress of
Neurological Surgeons, we are pleased to endorse the nomination of
Governor Mike Leavitt for Secretary of the Department of Health and
Human Services (HHS) and we urge the Senate to approve his appointment
as soon as possible.
Throughout his years in government service, Governor Leavitt has
demonstrated his ability to be a leader and innovator on many
healthcare issues. A results oriented leader, he has a proven track
record of tackling and solving difficult healthcare problems, including
expanding healthcare coverage for the uninsured and changing the
welfare system. These initiatives have had a particularly positive
impact on some of our Nation's most vulnerable citizens, our children.
Governor Leavitt has also demonstrated his ability to work in a
collegial and bipartisan fashion, which will clearly be vital to
advancing some very challenging healthcare policy issues such as
medical liability reform and the implementation of the Medicare
Modernization Act.
America's neurosurgeons are confident that Governor Leavitt will be
an outstanding Secretary of HHS.
Respectfully,
Robert A. Ratcheson, M.D.,
President, American Association
of Neurological Surgeons.
Nelson M. Oyesiku, M.D., Ph.D.,
President, Congress of
Neuorlogical Surgeons.
______
American Health Information Management Association
(AHIMA),
Washington, DC 20036,
January 21, 2005.
Hon. Mike Enzi,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, D.C. 20510.
Dear Senator Enzi: I am writing to express our strong support for
the confirmation of Governor Michael O. Leavitt as the Secretary of
Health and Human Services. Governor Leavitt's roles as the
Administrator of the Environmental Protection Agency and as Utah's
Governor has provided him with a critical understanding of our
government's executive operations at the national and State level,
including first-hand involvement with Utah's healthcare program.
Governor Leavitt's unique experience makes him an ideal choice to
lead the Department of Health and Human Services (DHHS). As you know,
DHHS is moving forward with a range of critical initiatives that
include the implementation of the Medicare prescription drug program,
Medicare reform, increased medical research and enhanced bioterrorism
and public health efforts. In addition, DHHS is addressing many issues
critical to AHIMA and its more than 50,000 members, including the
development and adoption of health information technology, migrating
from our outdated and broken 30-year-old ICD-9-CM coding system to ICD-
I0-CM and ICD-10-PCS, protecting the privacy and security of health
information, and expanding the health information management and allied
health workforce. AHIMA believes that Governor Leavitt is the right
choice to lead these efforts, at the right time.
AHIMA remains committed to its goal of ``quality healthcare through
quality information'' and is dedicated to enhancing and improving
healthcare. Founded in 1928 to improve the quality of medical records,
AHIMA works diligently to advance the health information management
profession in an increasingly electronic and global environment. AHIMA
has a reputation for working on a bipartisan basis with elected
officials and health policymakers and we look forward to working with
you to confirm Governor Leavitt and to advance health information
management and technology issues.
If I can provide you with any further information, please do not
hesitate to call me in the AHIMA Washington, D.C. Office at 202-659-
9440 or at [email protected].
Sincerely,
Daniel F. Rode,
Vice President,
Policy and Government Relations.
______
American Osteopathic Association (AOA),
Washington, DC 20005-4949,
January 12, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Chairman Enzi and Ranking Member Kennedy: As President of the
American Osteopathic Association (AOA), I write to express our strong
support for the nomination of Governor Michael O. Leavitt to be
Secretary of the Department of Health and Human Services (HHS).
The AOA represents the Nation's 54,000 osteopathic physicians
practicing in 23 specialties and subspecialties. We applaud his
nomination and encourage the Senate to approve his appointment at its
earliest opportunity.
Throughout his career, Secretary-Designate Leavitt has demonstrated
sound and disciplined leadership. These traits will benefit HHS as the
agency addresses the numerous health care challenges facing our Nation.
Additionally, he has a strong health care background and understands
the access, workforce and financial challenges facing Medicare and
Medicaid. We are especially appreciative of his efforts as Governor of
Utah to improve the physician workforce in rural and underserved
communities.
The AOA applauds his nomination and stands ready to work with
Secretary Leavitt on improving the Nation's health care delivery
system. Please contact the AOA's Department of Government Relations at
(202) 414-0140 for additional information.
Sincerely,
George Thomas, D.O.,
President.
______
Alliance of Specialty Medicine,
January 17, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Chairman Enzi and Ranking Member Kennedy: The undersigned
members of the Alliance of Specialty Medicine wholeheartedly support
the nomination of Governor Mike Leavitt for Secretary of the Department
of Health and Human Services (HHS). We urge the Senate to approve his
appointment as soon as possible.
The Alliance is a coalition of 12 national medical specialty
societies representing more than 220,000 physicians. Our non-partisan
group is dedicated to the development of sound federal health care
policy that fosters patient access to the highest quality specialty
care.
Governor Leavitt has the experience and leadership skills needed to
take the helm of HHS at a crucial time. He will be tasked with the
implementation of the Medicare prescription drug plan and solving
physician reimbursement and medical liability challenges. Governor
Leavitt knows the value of building a consensus to solve tough
challenges together. He is a common-sense leader who knows how to
deliver results.
The Alliance is ready to work with Secretary Leavitt on improving
the health care and well-being for America's citizens. Please contact
the Alliance at (202) 728-0610 for additional information.
Sincerely,
American Academy of Dermatology Association,
American Association of Neurological Surgeons/Congress of
Neurological Surgeons,
American Association of Orthopaedic Surgeons,
American College of Emergency Physicians,
American College of Obstetricians and Gynecologists,
American Gastroenterological Association,
American Society for Therapeutic Radiology and Oncology,
American Society of Cataract & Refractive Surgery,
American Urological Association,
National Association of Spine Specialists,
Society of Thoracic Surgeons.
______
The Council for Affordable Health Insurance (CAHI),
Alexandria, VA 22314,
January 17, 2005.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Senator Kennedy: I wanted to take this opportunity to express
the Council for Affordable Health Insurance's (CAHI) strong support for
Governor Leavitt's nomination as secretary of the Department of Health
and Human Services.
CAHI is a research and advocacy association of insurance carriers
active in the individual, small group, HSA and senior markets. CAHI's
membership includes health insurance companies, small businesses,
physicians, actuaries, and insurance brokers. Since 1992, CAHI has been
an advocate for market-oriented solutions such as HSAs to the problems
in America's health care system.
As a three-term governor, Mike Leavitt is a proven leader and
administrator who has successfully led his State in several health care
and welfare reform initiatives. That is important because the country
faces several health care challenges: reducing the number of uninsured;
ensuring that people, especially those with pre-existing medical
conditions, have access to affordable health coverage; and addressing
the growing financial problems facing Medicare and Medicaid.
The country needs a strong, innovative leader who has the patience
to listen to others about how to effectively address our health care
challenges and motivate the department, the health care community, and
State and Federal elected officials to adopt legislation and best
practices that will solve the problems.
We at the Council believe that Governor Leavitt is the right person
at the right time for a very big job, and we encourage you to approve
his nomination in a timely manner.
Faithfully,
Merrill Matthews, Ph.D.,
Director, Council for Affordable Health Insurance.
______
Federation of American Hospitals TM,
Washington, DC 20004-2604,
January 14, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Charles Grassley,
Chairman,
Committee on Finance,
U.S. Senate,
Washington, DC 20510.
Hon. Max Baucus,
Ranking Member,
Committee on Finance,
U.S. Senate,
Washington, DC 20510.
Dear Chairmen and Ranking Members: The Federation of American
Hospitals is pleased to support strongly the nomination of Governor
Mike Leavitt as Secretary of the Department of Health and Human
Services (HHS). Governor Leavitt will be a wonderful addition to the
President's cabinet, and the Federation urges quick approval of his
nomination.
Governor Leavitt's demonstrated leadership and organizational
skills, his vision, and his public policy expertise in health care make
him exceptionally qualified to lead HHS. In addition, his ability to
work with diverse groups and across party lines paired with his
congenial manner qualify him as an outstanding choice to serve as HHS
Secretary, particularly when considering the often contentious issues
before the Department.
America's investor-owned hospitals know Governor Leavitt as a
champion for constructive and thoughtful leadership. Again, we commend
him and encourage the committees and the Senate to rapidly approve his
nomination.
With warm regards,
Charles N. Kahn III,
President.
______
Galen Institute,
Alexandria, VA 22320,
January 16, 2005.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Senator Kennedy: I am writing to express strong support for
President Bush's nomination of Governor Michael O. Leavitt to serve as
Secretary of the Department of Health and Human Services.
Governor Leavitt has demonstrated his extraordinary leadership
abilities as a governor and as Administrator of the Environmental
Protection Agency, abilities that will be essential in managing a
department as large and with as many responsibilities as DHHS.
Serving as a governor his given him valuable experience with key
programs managed by the department. For example, he demonstrated both
skill and creativity in implementing the State Children's Health
Insurance Program. And he has been a leader in developing new ways to
extend health coverage to the citizens of Utah through Medicaid
waivers. Those skills will be invaluable in advancing President Bush's
health policy agenda to provide health insurance to millions of
uninsured Americans and to make coverage more affordable and
accessible.
Governor Leavitt will serve the Department and the Nation well, and
I strongly urge the committee to recommend to the U.S. Senate his
confirmation as Secretary of Health and Human Services.
Sincerely,
Grace-Marie Turner,
President.
______
January 19, 2005.
Hon. Charles E. Grassley,
Chairman,
Committee on Finance,
U.S. Senate,
Washington, DC 20510.
Hon. Max Baucus,
Ranking Minority Member,
Committee on Finance,
U.S. Senate,
Washington, DC 20510.
Hon. Mike Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Hon. Edward M. ``Ted'' Kennedy,
Ranking Minority Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Chairman Grassley, Senator Baucus, Chairman Enzi, and Senator
Kennedy: We strongly support the confirmation of current EPA
Administrator Michael Leavitt for U.S. Secretary of Health and Human
Services. As former colleagues, we have all worked with him in a
bipartisan manner and found him to be an individual of great
intelligence, honesty, and integrity, Furthermore, be has a thorough
understanding of both welfare and Medicaid, which are two programs of
major importance to our Federal-State partnership.
We urge your committees to support Governor Leavitt's confirmation
and look forward to a quick vote by the Senate.
Sincerely,
Governor Mark R. Warner,
Virginia.
Governor Jennifer Granholm,
Michigan.
Governor Thomas J. Vilsack,
Iowa.
Governor Jim Doyle,
Wisconsin.
______
Healthcare Leadership Council (HLC),
Washington, DC 20004,
January 17, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.
Dear Chairman Enzi: On behalf of the members of the Healthcare
Leadership Council--chief executives of the Nation's premier health
care companies and institutions--strongly urge you to support President
Bush's nomination of Michael Leavitt to serve as Secretary of the U.S.
Department of Health and Human Services,
Governor Leavitt is a sound choice to serve as HHS Secretary and
has the skills and experience to serve the Nation well in this
challenging position.
Governor Leavitt is an innovator. As governor of the State of Utah
and as chairman of the National Governors Association, he was a strong
advocate for giving States more creative flexibility in using Federal
funds to better serve the health needs of their citizens. At a time
when we must strive to make health insurance coverage more accessible
to the tens of millions of citizens who are without it, Governor
Leavitt's openness to new ideas and his determination to meet the
health care heeds of the American people are welcome qualities.
He has a reputation as a pragmatic consensus-builder. This, too, is
a welcome characteristic at a time when Washington, all too often,
finds itself gridlocked on critical health care priorities. We need
progress on issues ranging from the uninsured to health information
technology dissemination to medical liability reform and we believe
Governor Leavitt can be effective in finding common ground on these
matters.
And, finally, Governor Leavitt has established himself as a strong
manager, both in Utah and at the Environmental Protection Agency. This
is no small credential for someone who will assume the reins of an
institution as large and complex as HHS. And, as we move toward full
implementation of the Medicare Modernization Act, a strong
administrator at the HHS helm is a necessity.
In short, we believe that President Bush has made the right choice
for a cabinet position of extraordinary importance and we encourage you
to vote for Governor Leavitt's confirmation.
Sincerely,
Mary R. Grealy,
President.
______
Chamber of Commerce of the United States of
America,
Washington, DC 20062-2000,
January 12, 2005.
Hon. Michael B. Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Chairman Enzi: The U.S. Chamber of Commerce, the world's
largest business federation representing more than 3 million businesses
of every size, sector and region, strongly supports the nomination of
Mike Leavitt to be Secretary of Health and Human Services.
Mike Leavitt has an exemplary track record for addressing the
issues of healthcare access and affordability as the former Governor of
Utah. As the Administrator of the Environmental Protection Agency, he
worked diligently to bring all sides together and address the public
health risks posed by emissions in a manner that cleaned the air
without disrupting the economy.
The Chamber looks forward to working with the nominee in
implementing the Medicare Modernization Act, particularly as it
pertains to retiree health benefits, in advancing proposals making
health coverage more affordable and accessible to all Americans, and in
improving the safety and efficiency of our Nation's health delivery
system.
We urge the committee's quick approval of this nomination and
favorable recommendation for confirmation by the full United States
Senate.
Sincerely,
R. Bruce Josten,
Executive Vice President,
Government Affairs.
______
National Alliance for Hispanic Health,
Washington, DC 20036-1401,
January 14, 2005.
Hon. Mike Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, D.C. 20510-6300.
Dear Senator Enzi: On behalf of the membership of the National
Alliance for Hispanic Health (the Alliance), I am pleased to offer our
full support for the swift confirmation of Mike Leavitt as the next
Secretary of Health and Human Services. The Alliance is the Nation's
largest and oldest organization committed to improving the health of
Hispanics. Alliance members reach over 12 million Hispanics every year
through the provision of direct services.
The Alliance worked with Administrator Leavitt when he was Governor
of Utah and Chairman of the Western Governor's Association (WGA). As a
founding board member of the Patient Safety Institute (PSI), the
Alliance witnessed first hand then-Governor Leavitt's work with WGA to
move forward new technology to realize the benefits of electronic
patient health information. We look forward to his leadership on this
issue as Secretary of Health and Human Services.
Our Utah-based community organization members describe Mike Leavitt
as an effective advocate for Hispanic issues who has also been very
supportive in the health arena. They describe him as a listener and
quick learner who tempers his search for solutions with his knowledge,
insight, and commitment to balance. For example, when he established
his health policy commission in Utah he made sure that the group was
diverse and included strong community advocates. Most impressive was
his work with the health community to be proactive with the Children's
Health Insurance Program (CHIP).
We are fortunate to have a person of the caliber and commitment of
Mike Leavitt in public service. Our Nation's health system will benefit
from his stewardship and the Alliance looks forward to his
confirmation.
Sincerely,
Jane L. Delgado, Ph.D., M.S.,
President and CEO.
______
Republican Governors Association,
Washington, DC 20004,
January 13, 2005.
Hon. Mike Enzi,
Chairman,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510-6300.
Hon. Edward Kennedy,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510.
Dear Chairman Enzi and Senator Kennedy: We are writing to express
our strong support for Administrator Mike Leavitt to be the next U.S.
Secretary of Health and Human Services.
As Governor of Utah, Administrator Leavitt improved health care in
numerous ways. His work to enact the Children's Health Insurance
Program (CHIP) in Utah helped reduce the uninsured rates for children
to its lowest point ever. His administration worked to increase the
number of Utahans with health insurance by 400,000 and raise
immunization rates by nearly 75 percent. He also was a leader in using
technology to enhance the quality of health care and reduce costs.
Mike Leavitt was chosen by his gubernatorial colleagues to lead
numerous organizations during his time as Governor. In those roles, he
was a critical voice in the national discussions on the reform of
Medicaid and welfare and in the crafting of CHIP. He was chosen for
these leadership positions because of his command of the issues, his
bipartisan temperament and his ability to listen to all sides and
fairly synthesize different viewpoints.
His reputation for seeking consensus has served him well as EPA
Administrator. We believe that this leadership style will be put to
good use in working with the country's Governors toward the
implementation of the permanent Medicare prescription drug benefit in
2006, improving the Medicaid program, ensuring an adequate supply of
vaccines, holding the line on health care costs and other important
health care causes.
For his record of leadership, his steadiness of purpose and ability
to get results, we heartily endorse Administrator Mike Leavitt to be
the next Secretary of Health and Human Services.
Sincerely,
______
National Association of Health Underwriters (NAHU),
Arlington, VA 22201,
January 17, 2005.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Senator Kennedy: On behalf of the National Association of
Health Underwriters and our entire Board of Trustees, I would like to
wholeheartedly support the nomination of Governor Mike Leavitt for
Secretary of the Department of Health and Human Services. Our Utah
chapter has worked with Governor Leavitt extensively on health issues
of all kinds and has given us their strongest vote of confidence in his
knowledge, strength of character, and ability to get things done.
One of the most critical concerns in selecting the right person to
lead a government agency as large as the Department of Health and Human
Services is the ability not only to personally communicate well, but
the ability to find ways to facilitate that type of communication with
others both within the agency and among the citizens the agency serves.
While governor of Utah, Governor Leavitt's ability to strategize
effectively on technology resulted in an e-government initiative that
made more than 110 State Government services available over the
Internet.
Governor Leavitt has also shown himself to be an effective leader
and communicator within organizations such as the National, Western,
and Republican governors associations. He has been repeatedly chosen by
his peers to lead them, and that same leadership ability also resulted
in Utah being recognized six times as one of America's best-managed
states.
Our NAHU leaders in Utah know firsthand that Governor Leavitt's
health care experience will result in innovative ideas being proposed
and implemented. In 1994, Governor Leavitt proposed a comprehensive
incremental approach to health care improvement that has resulted in
400,000 more Utahans having health insurance than did before, better
use of the children's health insurance program, and improved
immunization rates, all while decreasing the per capita cost of health
care in his State to 25 percent below the national average. Certainly
these types of skills are just what is needed at the Department of
Health and Human Services.
We are confident that the Senate will recognize the tremendous
potential Governor Leavitt has to offer and we look forward to working
together with him and the Senate HELP Committee to improve access to
affordable health care for Americans from coast to coast. Should you
need any additional information or if we can move this process forward
in some other way, please let me know. I can be reached at (703) 276-
3806.
Sincerely,
Janet Trautwein,
Vice President of Government Affairs.
______
National Association of Manufacturers (NAM),
Washington, DC 20004-1790,
January 6, 2005.
Hon. Michael B. Enzi,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510-6300.
Hon. Edward M. Kennedy,
Ranking Member,
Committee on Health, Education, Labor, and Pensions,
Washington, DC 20510-6300.
Dear Chairman Enzi and Ranking Member Kennedy: On behalf of the
members of the National Association of Manufacturers (NAM), the
Nation's largest industrial trade association, representing small and
large manufacturers in every industrial sector and in all 50 States, I
write to express our strong support for the nomination of former Utah
Governor Michael Leavitt to serve as Secretary of Health and Human
Services.
Governor Leavitt is superbly qualified to serve as the Nation's
Secretary of Health and Human Services (HHS). President Bush has chosen
a leader who has been a successful manager of complex organizations
like the State of Utah and the EPA. Governor Leavitt understands well
the importance of building a more affordable health care system and the
impact of health care costs on America's economic competitiveness in a
challenging global economy. As Governor, I worked closely with Governor
Leavitt on Medicaid and Welfare reform. Governor Leavitt was one of the
lead Governors in the National Governors Association during the
historic reforms of 1995-96. I know first-hand that he is a creative
problem-solver who excels at innovation and management.
Governor Leavitt's leadership will be critical on the myriad
complex issues before HHS, including deploying health information
technology, promoting disease prevention and management and securing
America's food and drug needs. He is the right choice at the right time
to lead our Nation's health and human services agenda.
I hope that you will act promptly and favorably upon Mike Leavitt's
nomination. If there is any way that the NAM can be of assistance to
you, please do not hesitate to contact us.
Sincerely,
John Engler,
President and CEO.
______
Safe Food Coalition,
Washington, DC 20036,
January 14, 2005.
Hon. Mike Enzi,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, DC 20510.
Dear Senator Enzi: On behalf of the diverse group of Americans we
represent, the Safe Food Coalition respectfully requests that you
submit the attached questions to EPA Administrator Mike Leavitt to
answer during his confirmation hearing as U.S. Secretary of Health and
Human Services scheduled for Tuesday, January 18, 2005.
Thank you for considering our request on this very important issue.
If you have any questions please respond directly to Ken Kelly at (202)
332-9110 ext. 319 and he will share your response with the
organizations below.
Sincerely,
Carol Tucker,
Foreman, Consumer Federation of America.
Caroline Smith DeWaal,
Center for Science in the Public Interest.
Karen Taylor Mitchell,
Safe Tables Our Priority.
Tony Corbo,
Public Citizen.
Tom Devine,
Government Accountability Project.
Alison Rein,
National Consumers League.
Sally Greenberg,
Consumers Union.
Questions of the Safe Food Coalition for Governor Mike Leavitt
Modernizing Food Safety Laws
The National Academy of Sciences has said that food safety and
quality in the U.S. is governed by a fragmented and overlapping system.
It is based on laws, several of which were adopted in 1906, which means
they are nearly 100 years old.
Question 1. Given how much the food industry has changed in the
last 100 years, do you think that the food laws should be modernized to
address new issues and hazards, like food borne pathogens, mad cow
disease and genetically modified food?
Mandatory Recall
Currently, the Food and Drug Administration (FDA) does not have
mandatory authority to recall contaminated food products. FDA must rely
on voluntary cooperation by food companies to get contaminated food out
of supermarkets, restaurants, and consumers' homes. FDA identified
3,248 recalls of non-meat and poultry foods from 1986 to 1999 and GAO
identified nine instances during that time where companies delayed
compliance with an FDA recall request.
Question 2. Do you think that FDA should have mandatory recall
authority in order to protect American, consumers from unintentional
contamination by food that is imported into the country?
Bioterrorism
The outgoing Secretary of Health and Human Services Tommy Thompson
recently stated that ``I, for the life of me, cannot understand why the
terrorists have not attacked our food supply, because it is so easy to
do.'' Secretary Thompson's concerns seem justified: Since 1994, food
imports have grown five-fold to six million food import shipments, but
the Food and Drug Administration (FDA) inspects only around 2 percent
of these shipments. In addition, FDA does not have mandatory authority
to recall contaminated food that it regulates.
Question 3. How would you improve FDA's oversight to imported food?
For example, do you support the allocation of additional inspectors to
the FDA in order to bolster food inspections at ports of entry in order
to protect American consumers from the threat of both intentional and
unintentional contamination of the U.S. food supply?
Question 4. Do you think that FDA should have mandatory recall
authority to protect consumers from contaminated food that is
distributed around the country?
Feed Ban
On January 26, 2004, HHS Secretary Tommy Thompson and then-FDA
Commissioner Mark McClellan held a press conference to announce a new
interim final rule that would tighten the feed regulations for bovines
as a strengthening of the firewalls against bovine spongiform
encephalopathy (BSE). This rule was to prohibit mammalian blood,
poultry litter and plate waste as feed ingredients for ruminant
animals. It would also require animal feed manufacturers to maintain
segregated production lines to ensure that ruminant feed is not
contaminated. A year later, this interim final rule has not been issued
and none of these loopholes have been closed, leaving American
consumers vulnerable to mad cow disease.
Question 5. What actions will you take to ensure that the measures
announced by Secretary Thompson and FDA Commissioner McClellan are
implemented immediately?
Trade With Canada
Two additional cases of mad cow disease have been identified in
Canada in the last 2 weeks. In a recent letter sent by Senator Kent
Conrad and Congressman Henry Waxman to USDA Secretary-designate Mike
Johanns, they quoted from recent FDA ``import alerts'' and found that
over the past 15 months, 17 Canadian feed companies have been cited by
FDA for not meeting our current bovine feed regulations.
Furthermore, the Vancouver Sun on December 16, 2004 published an
investigative report in which it cited Canadian Food Inspection Agency
documents that showed seven Canadian feed mills with ``major non-
compliance issues.'' Three mills failed to ``prevent the contamination
of ruminant feeds with non-ruminant feeds'' and in one of these cases
the contaminated feed was actually consumed by other cattle.
Question 6. In light of these findings, do you believe that it is
wise for the United States to resume beef and cattle trade with Canada
at this time?
Anti-Microbial use in Animals
Anti-resistant strains of toxic pathogens, like Salmonella Super 9,
have been increasing in recent years. Many scientific groups, like the
CDC, cannot form valid risk assessments without information from drug
companies on anti-microbial use of their drugs in animals, but current
disclosure restrictions thwart real attempts to improve or design
appropriate preventive measures.
Question 7. What course will you follow in getting drug companies
to release information on anti-microbial use in animals? Are you
willing to work towards building more open disclosure policies for all
levels of animal production?
Traceability
Recently, departing Secretary of Health and Human Services Tommy
Thompson made alarming comments regarding our food supply, claiming
that it was vulnerable to attack by terrorists. Currently, there is no
uniform traceability system in place for meat and poultry (USDA) and
other contaminated foods (FDA) that would enable an effective and
timely recall. Without a traceability system in place, it is almost
impossible to trace contaminated food, both backwards to the source and
forward through its distribution into the marketplace, allowing timely
notification to the public.
Question 8. In the absence of uniform traceability, if a
bioterrorism attack were to occur within our food supply, how does the
government intend to respond? Should the government be developing
traceability regulations that would result in contaminated food being
recalled more effectively and completely, and which would include
providing the public with complete information in a timely manner?
The Chairman. Governor Leavitt, proceed.
STATEMENT OF MICHAEL O. LEAVITT, OF UTAH, NOMINATED TO BE
SECRETARY, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Mr. Leavitt. Chairman Enzi, thank you very much, and
Senator Kennedy, for your graciousness. Leader Frist, thank
you, and members of the committee. May I say that my heart
requires that I express appreciation--appreciation to the
President for his confidence, appreciation to this committee
for the graciousness with which I've been received as I have
had a chance to move about and get acquainted with each of you,
appreciation of the committee staff on both sides of the aisle
who have been extraordinarily helpful in being able to go
through the process that is necessary, an advise-and-consent
constitutional process.
I would also like to express directly my admiration for
Secretary Tommy Thompson. Tommy Thompson is a man who was a
friend of mine while we were Governors. We served together not
only as Governor, but he was a friend of the State of Utah
while he was Secretary of HHS, allowed and empowered a number
of important innovations and helped us solve problems. I
believe America is stronger as a result of his service. I think
the Department of HHS is stronger. People at HHS love Tommy
Thompson. He is well respected on Capitol Hill, and I
understand why. I want to pledge to him and to you that I will
build on the legacy that he has built.
I would also very much like to acknowledge and express
appreciation for the sentiments of my friends Senator Hatch and
Senator Bennett, and the others who have expressed support for
my confirmation. Their expressions this morning are warming
impressions of a friend as well as professional colleagues, and
I deeply appreciate it.
Mr. Chairman, I have prepared and submitted a written
statement. In the interest of time and with an anxiousness to
get to your questions, I am going to submit that and ask it be
included in the record. But I would like to just cover, if I
could, a few observations about the things I believe, about the
vision or the feelings I have for the mission of the
Department, and perhaps some of the things that we will need to
face together.
First of all, let me say that I believe public service is a
trust, and the most important thing I believe I can say to you
today is that I give you my commitment that I will conduct that
trust with fidelity.
I would also like you to know that I believe that this
Nation has a responsibility to care for the truly needy, but it
is also our generational responsibility to foster and to teach
self-reliance. Self-reliance is a prerequisite of freedom and
of prosperity.
I would like to also acknowledge the deep belief I have in
the mission of the Department of Health and Human Services. It
is clear to me that when families gather around their table at
night that in this Nation they are able to do so with
confidence knowing that their food is protected and safe. We
live in a nation that when we awake in the middle of the night
and administer medicine to a child, we do so with the
confidence that it is safe.
I would also like to acknowledge the profound importance I
think that this Department has on the administration and the
development of health care policy in this country. It affects
us all from the moment we enter this life until the moment we
leave.
I am also quite conscious and feel very sensitive about the
importance this Department plays in allowing us to meet our
most noble aspirations as a society to care for those who are
in need, the welfare of families, the health of families, and
the ongoing capacity for us to assure that the truly needy in
our society are, in fact, cared for.
In the course of the last several years, we have become
more conscious of a new role that HHS plays, and that is its
new important role in the fight for a safe homeland.
I would like to just, if I could, review a couple of the
subjects that I know we will want to talk more about and that I
feel confident that we will deal with over the course of our
time if I am successful in my nomination and confirmed. The
first is Medicare.
May I just say that successful implementation of the
Medicare Modernization Act will be the main event at HHS in the
year 2005. The time frames are short. The expectations are
high. The interest is wide. The implications are long. There
will inevitably be flaws, but we will not fail.
Senator Kennedy and others mentioned the reauthorization of
welfare. I believe this is an American success story. What we
have accomplished in the last 6 years is something that must be
continued and improved upon, and I look forward to working
together with all of you to see the reauthorization of this
important program.
Medicaid. I believe Medicaid is a vital program. I believe
it is a remarkably important means by which we serve the poor
in this country. But it is not meeting its potential to do good
in the lives of the poor that it can. I mentioned to one of you
in a meeting that I had with you privately in your office, when
asked what it was about this responsibility that appealed to
me, I reflected that some 6 years ago or 7 years ago, I
appeared many times before this committee and others when we
were working on welfare reform and Medicaid. We succeeded, I
believe, well with Medicare--rather, with welfare. We did not
succeed on Medicaid, and I vowed if I ever had a chance to work
on it again, I would. And I look forward to working with you to
find ways in which we can serve this very important population
in ways that will meet its full potential.
I would also like to recognize the importance of protecting
three very important American brands: the FDA, the CDC, and
NIH. Those I refer to as ``brands'' because a brand is a
promise. It is a reputation. And it is clear to me that the
American people depend on that promise. And we need to protect
the integrity of those American treasures.
Large-scale discussions in my mind are beginning to grow on
the whole subject of health care policy and how we deliver it.
I welcome it. That discussion needs to be bold and it needs to
be transformational, and we start with medical liability,
something that badly needs to be improved.
I will also recognize this morning in my introduction the
role I believe the United States of America has in influencing
the rest of the world as a good humanitarian voice.
Now, Mr. Chairman, when I entered public service, I adopted
three goals, perhaps consistent with our Western roots: I
committed that I would leave it a better place than I found it,
that I would plant seeds for a future generation, and that I
would give it all I have. It is that pledge I leave with you
today and look forward to interacting with you on the issues I
have spoken of and many others that I am sure you will raise
today and in the future. I look forward to an opportunity.
Thank you.
[The prepared statement of Mr. Leavitt follows:]
Prepared Statement of the Honorable Mike Leavitt
Good morning Mr. Chairman, Senator Kennedy, and members of
this committee. Thank you for inviting me to discuss my
nomination to be Secretary of Health and Human Services.
I would like to begin by expressing my immense admiration
for Tommy Thompson. We have been friends for many years, but my
admiration is broader than just friendship. I admired his
leadership as Governor of Wisconsin. The two of us worked
together on many of the issues we will talk about today. He
also brought an aggressive agenda to HHS, and his 4 years at
the helm have made America healthier and safer.
Consider: Medicare is providing more comprehensive care to
more American seniors than ever before. HHS is better prepared
than ever to respond to public health emergencies. More
children receive immunizations and health care, and fewer use
drugs. The Food and Drug Administration is inspecting seven
times as much imported food as it did 4 years ago. And, thanks
to the leadership of President Bush and Secretary Thompson, the
United States leads the struggle against AIDS around the world.
Tommy has earned the affection and respect of the people of
HHS, and I pledge to him and to you that, if confirmed, I will
build on his legacy.
I have enjoyed every stage in my career, from business, to
being Governor of Utah, to protecting the environment as
Administrator of EPA. Now, President Bush has asked you to
confirm me as Secretary of Health and Human Services. I want to
thank him for his confidence and thank you for assessing my
fitness to serve.
As a prelude to answering your questions it may be helpful
if I tell you what I believe, what issues and opportunities I
see confronting our Nation, and how I view the Department of
Health and Human Services.
I believe conducting the public's business is a sacred
trust. I pledge that I will serve with fidelity and full
effort.
I believe collaboration trumps polarization every time and
that solutions to complex problems have to transcend political
boundaries.
I believe that information technology is challenging old
institutions, bridging great distances, and giving people more
control over their own lives. To survive, governments will have
to be more flexible and more competitive.
I believe market forces are superior to mandates. People do
more, and do it faster, when they have an incentive to do the
right thing.
I believe we should reward results, not efforts. Our focus
should always be the outcomes we are striving to achieve.
I believe that to change a nation, you have to change
hearts. And you change hearts through education and example.
I believe government must care for the truly needy and
foster self-reliance and personal charity. Helping others is
good for the soul. Government can augment this compassion and
provide services, but it can never replace the love that makes
us help each other.
I expect the Department of Health and Human Services to
achieve our Nation's noblest human aspirations for safety,
compassion, and trust.
When we gather our families for dinner at night, we rely on
HHS to ensure the food we put on the table is safe.
When we are alone at night caring for a sick child, we
trust HHS to ensure that the medicine we give her is effective.
Our poor, disabled, and elderly have health insurance
because this Nation has made it a priority; another powerful
stewardship that has been given to HHS.
The Department of Health and Human Services helps to
strengthen marriages and families, protects children, and
fights disease. For example, we are often called upon to
protect neglected and abused children. But we can never replace
the love of a parent.
And if, God forbid, terrorists should ever unleash a
biological agent on American soil, we would rely on the
dedicated men and women of HHS and the plans they have
developed already to stop the disease in its tracks and protect
Americans.
We all know that HHS spends nearly one out of every four
dollars collected by the Federal Government in taxes. I am
humbled by the prospect of shouldering that responsibility.
I would like to thank the members of this committee for the
kindness you showed me as I visited your offices. Our
conversations have been helpful as I contemplate this task. One
of you said, only partly joking, ``Why would you want a hard
job like that.'' There are so many reasons. Let me mention a
few, beginning with welfare and Medicaid.
Welfare Reform
In the late 1990s, in my role as Chairman of the National
Governors Association, I worked closely with Congress and other
governors in building the federal-state partnership we called
welfare reform. We can all be proud of this dramatic American
success story. We set a tone of compassion for this country by
caring for those in need and fostering self-reliance. Now I
look forward to working with you to ensure that welfare reform
is reauthorized and improved.
Medicaid
During the same period, Congress worked hard at reforming
Medicaid, but ultimately failed. I vowed then that if the
opportunity ever arose again, I would seize it. Delivering
health care to the needy is important, but Medicaid is flawed
and inefficient. We can do better. We can expand access to
medical insurance to more people by creating flexibility for
our State partners and transforming the way we deliver it.
Medicare
When you and your colleagues approved the Medicare
Modernization Act, Mr. Chairman, that was a great achievement.
And you asked us to implement the Medicare prescription drug
benefit on January 1, 2006. This is a great challenge.
I have no illusions about the size of the task. It is
immense. But I recognize that the President and the Congress
made a solemn commitment to America's seniors. I have the
responsibility of delivering on that commitment. Our work will
not be without flaw, but we will not fail.
Global
This Nation's compassion is not limited to America. We live
in a prosperous country. And our prosperity is not only a
blessing--it's also an obligation. While the world sometimes
envies or resents us, it always respects us. And when we do the
right thing, others emulate our example.
In international health, one of our Nation's greatest
strengths is our considerable convening power--it's our ability
to inspire, to set an example, and to call upon the best
knowledge, experience, and resources, from individual experts,
private institutions, and government agencies.
I resolve to use this convening power to meet our
obligation as human beings to improve health and well-being. We
will reach out to reduce suffering, to promote understanding,
and to inspire compassionate action.
FDA, NIH, and CDC Brands
HHS is the trustee for a number of our Nation's most
treasured brands. A brand is a promise. Over decades, the
dedicated scientists and researchers of HHS have earned the
public's trust, especially in three brands: FDA, NIH, and CDC.
To millions of people, these brands are seals of quality,
safety, and best in the world research. If they lost their
reputations, they would take years to recover. HHS always needs
to keep in mind the ethical implications of its decisions, to
ensure that Americans can be proud, not only of the
Department's scientific expertise, but also of the moral
judgment of its leaders.
At FDA, our goal must be to inform consumers about risks
and benefits. Our foundation must be sound science. Our motto
must be independence.
At NIH, we must march forward with life-saving research,
and always hold the scientists, universities, and laboratories
accountable for results.
At CDC, our guiding focus must be disease prevention and
control, sharing generously the best health and safety
information in the world.
Liability
Most doctors make a sincere effort to do a good job, but
medical errors do occur. People who are harmed by medical
errors absolutely deserve prompt and fair compensation.
Unfortunately, the capricious liability system that prevails in
many States helps no one. Senators, I look forward to working
with you to pass comprehensive medical liability reform.
Twenty-First Century Health Care
Most broadly, Americans deserve the health care of the 21st
century. We've earned it. That includes modern medical
technology. Modern information technology. And modern,
consumer-focused delivery systems.
I see a world that is rapidly moving toward personalized
medicine. People will own their own health savings, health
insurance, and health records.
I see a world in which a doctor can write a prescription on
a handheld device and transmit it to the patient's pharmacist,
who can start filling it before the patient leaves the doctor's
parking lot--and with less chance of error or delay.
I see a world where doctors heal our loved ones when they
are sick, but focus more of their energies on keeping them well
in the first place.
I see a world where good health care makes America more
productive, not less competitive.
And I see a world where premier health research serves the
betterment of mankind.
Conclusion
Mr. Chairman, I have always had three goals in public
service. I followed them as Governor of Utah. I've followed
them as Administrator of EPA. And I will follow them as
Secretary of Health and Human Services.
The first goal is to leave things better than I found them.
The second goal is to plant seeds for future generations.
And the third goal is to give it all I have.
I promise to work with this committee in a responsive and
transparent manner so we can do just that.
Thank you for your attention, Mr. Chairman. I look forward
to answering your questions.
The Chairman. Thank you very much. I appreciate the brevity
of your statement and want to assure you that your full
statement will be a part of the record. I would also say that
our prayers are with your wife for a speedy recovery and for
your children who are flying in for a safe arrival.
Mr. Leavitt. It is just an isolated epidemic of the flu in
the Leavitt family. I am hopeful I can demonstrate my prowess
as head of health, in my home at least, and get her better.
The Chairman. So I will not have to ask you any questions
about vaccines because you will have a specific interest in
that.
I did mention some front-page issues that are up, and one
of those is the FDA's drug approval process, and I am sure you
will be reviewing the authority and the resources of FDA.
How can we best work with you to ensure that the FDA has
the proper authority and sufficient resources to perform the
regulatory function that we have assigned to them in an
effective and timely manner?
Mr. Leavitt. Senator, I have become increasingly aware, as
I know you and other members of the committee have, on the
constant tension that exists between our desire to have
innovation and speed to market and safety. Those are intuitive
to all of us on both sides and create a natural tension. It
will be finding the balance and working together to find ways
to expedite innovation, but at the same time being able to
protect it. I recognize that there are many, many issues still
remaining. I look forward to working and working through with
both those who manufacture and those who are responsible to
assure their safety that we can do so.
The Chairman. Well, I hope that America realizes that a
successful clinical trial does not guarantee the safety of a
drug through the life of the drug. Some rare but serious side
effects do not show up until after the drug is in wide
circulation. What role should the FDA play in identifying these
problems once a drug is on the market?
Mr. Leavitt. Senator, I believe we are moving into a
remarkable and powerful new era in medicine and particularly in
prescription drugs. I would refer to it as a personalized--an
era of personalized medicine where we will have the capacity in
the future to determine the effect of drugs not just on broad
populations but on specific cohorts and specific phenotypes
among populations of human beings.
This will require a focused, disciplined review over time
of the basic constructs and standards to which we hold
ourselves. It is an exciting thing and part of a larger
personal vision that I think this country can have of where we
begin to focus our medicine not on institutions and not on
broad populations but on people and on individuals and the way
things can affect them directly. The treasures that have been
unlocked in genetic research are very exciting and will change
the way we look at matters at the FDA as well as in our broad
policies that will need to be visited by this committee in a
broad public debate.
The Chairman. Thank you. I want to shift the focus just a
little bit. I know that you have been the cyber Governor and
have a huge interest in information technology. Last year
President Bush announced an ambitious plan to assure that every
American has electronic health records, and he called on
Secretary Thompson to appoint the first ever National
Coordinator of Health Information Technology. I applaud the
President for this emphasis on increasing the use of
information within our health care system, and Senator Kennedy
and I are intensely interested in doing some things to expedite
that.
What are the next steps that Congress and HHS should take
to make the vision of robust health care IT a reality?
Mr. Leavitt. Senator, I share with you the day--a vision of
the day when a physician will write a prescription on his
personal hand-held electronic device, that it will be
transmitted electronically to the patient's pharmacist who will
be filling it before he leaves the parking lot of his doctor's
office, and the health record will immediately be part of the
permanent record that that person takes with them when they go
to the next doctor's office for whatever purpose. I see that as
having enormous--just as a symbol of the enormous amount of
potential that we have in technology to streamline and make
efficient the whole system of medical delivery. When you
consider that medical services now approximates 15 percent of
the gross national product of this country, this is not just a
function of better health care; it is also a matter of economic
competitiveness.
I believe that the area of interoperability of systems, of
being able to sort through the very difficult, complex, and
sometimes thorny issues related to personal privacy and related
to assuring that those records are not used improperly will be
among the most important work that this committee can do in
order to facilitate that discussion and that promise.
The Chairman. Thank you. I am going to shift focus once
again to Medicaid because I know of your great work on that in
Utah. A longstanding concern of mine has been that there are
adults and children that are not enrolled, so they wind up in
that 43 million Americans that are uninsured, but really they
are just unenrolled. What do you think are the reasons for
this? And do you believe there is anything we can do to rectify
that situation?
Mr. Leavitt. Senator, I do. I feel passionately there are
things we can do to remedy that.
When I became Governor, only 86 percent of our children had
access to health insurance. Now virtually every child has
access, but 94 percent have health insurance. The CHIP program,
SCHIP program, has been a great success in our State and other
States. Some things have been revealed there to me that give me
great promise.
For example, many worried that we would not be able to
reach enrollment online among that population. In our State,
over 50 percent of our enrollees or nearly 50 percent have
enrolled online. We have also been able to reach into our rural
populations with that program. We have used our schools as a
method of being able to approach and find those who needed it.
It is simply a matter of finding them and helping them, making
it easy and helping them understand.
The Chairman. Thank you.
Senator Kennedy.
Senator Kennedy. Thank you.
Welcome, Governor I join you in your the great support for
the SCHIP program. I acknowledge the excellent leadership of my
friend and colleague, Senator Hatch, on that program.
Just a quick note and I want to keep moving. There was a
billion dollars that was returned last year that was not used
in the SCHIP program. There is a need in that program. In the
past when we had money that is returned, we have had a
bipartisan effort, which we do have now in the Congress. The
administration has been somewhat slow in giving us their
judgment, whether they would support returning those funds to
SCHIP as they have in the past, and I would hope maybe we could
work with you on this. I do not know whether you have a view on
this now. If it is not going to be encouraging, I would rather
not hear it.
[Laughter.]
But if you are open on it, if we could work with you on it,
there is a strong bipartisan effort to try and restore the
funds to get other children covered.
Mr. Leavitt. Senator, I am very optimistic about the sense
of value that exists in SCHIP, and I know that there is an
ongoing budget discussion that will be conducted between
Congresses.
Senator Kennedy. Just to pick up what the chairman said--
about IT. I am continually impressed with an article out of the
New England Journal of Medicine. I had not planned to bring
this up here, but since you mentioned, since our chairman did.
This is the data from the Latter Day Saints Hospital, and it
shows what has happened with improved IT: better outcomes such
as drug doses of medicine per patient, stays in the ICU, cost
per patient, mortality when this is replicated in system after
system. We need it in terms of interoperability, better quality
care, saving resources--although we may dispute how those
resources ought to be allocated. But let us get about it. I
would love to continue that conversation with the chairman, and
we talked about that in the past, but I thank you for your
strong interest in it.
If I could get to Medicaid. We know what we are facing in
terms of the 50 million Americans depending on Medicaid for
their health care. It is the poorest of the poor. The number of
Americans living in poverty has grown by 8 million in the last
4 years. We have about 800,000 more children that are living in
poverty. We see, in spite of increased need, that 38 States
have cut the Medicaid eligibility, 34 States have cut the
Medicaid benefits. Many States have not recovered from the
recession's impact on their revenues, and we hear that the
administration is planning to cut Federal support of Medicaid.
My own view of this is that it would be a move in the wrong
direction. You are a former governor. Do you think it is time
that we ought to be cutting Medicaid?
Mr. Leavitt. Senator, I have been one of those States who
have been in a situation of very difficult budget
circumstances, and it has always been my belief that we can
expand the number of people that we serve with available
resources. I have seen that happen many, many times, and I
believe our focus should be to take what is available and
expand the number of people who are provided with care.
Senator Kennedy. I agree. No one differs as long as the
people that need the help will receive the help, and it will be
quality help, if that is what you are saying, and doing it more
efficiently and effectively. But if you come to the point where
you are going to have a reduction in services, if you cannot
stretch it out, I would imagine you would be concerned about
that.
Mr. Leavitt. Senator, my purpose, if I am confirmed as
Secretary, will be take the resources that are available to us
and make certain that we are serving with basic quality health
care the broadest population possible. It is clear to me we can
serve a broader population if we allow the States greater
flexibility to use those resources to make sure that they are
devoting the resources, that they are putting up real dollars,
making real commitments, and that we are too, and doing it in
the most efficient way possible.
Senator Kennedy. I want to move on. There are increased
sorts of demands in terms of numbers of needy people on
Medicaid. I am all for getting a better bang for our dollar,
but I think there is real concern about whether we are going to
be squeezing and denying health benefits, which would be
unfortunate.
Let me move to Head Start. It has been an extraordinary
success. We are going to be reauthorizing it. We are always
interested in how it can be strengthened. We are always
interested in how it can be tied on into the No Child Left
Behind Program more effectively. We have 38 States now that
have even gone into pre-Head Start programs. But Head Start
works, and there are many of us who think that since it does
work why we should be trying to limit it. We have enough
challenges out there for different kinds of undertakings that
are not working. I am just interested in your view on that
program, on the Head Start, and any comments that you wanted to
make on the block grant, maintaining services or anything else
expanse that you want to address.
Mr. Leavitt. I share with you the belief that Head Start
works. I share with you that it serves a very important
preschool population and others. I share with you the view that
we can improve its effectiveness by better coordination with
other existing State programs.
Senator Kennedy. My time is up, Mr. Chairman.
The Chairman. Would you like to ask another question?
Senator Kennedy. I will wait till I get a second round.
Thank you.
The Chairman. Senator Frist.
Senator Frist. Thank you, Mr. Chairman.
Health care disparities, I continue to be troubled by the
obvious disparities in our health care system, the gaps that
this committee will hopefully continue to focus on aggressively
over the next Congress.
Just last week the Office of Minority Health of the CDC
reported that nonHispanic blacks bear a disproportionate burden
of disease, whether it is injury, death, morbidity, or
disability. In the CDC's report, just as an example,
nonHispanic blacks who died from HIV disease had approximately
11 times as many age-adjusted years of potential life lost
before age 75 years--that is on a per hundred thousand
population basis--than did nonHispanic whites. Non-Hispanic
blacks also had substantially more years of potential life lost
than nonHispanic whites for homicide, nine times as many I
believe. Stroke was three times as many. Perinatal diseases,
it's either three to four times as many, somewhere in that
range. The report documents disparities one after another. The
documentation phase is not over because it is very important to
do, but now is the time for action and for solutions. I
appreciate the administration's commitment to reducing these
disparities, the social disparities, the socioeconomic
disparities, the racial disparities, the geographic disparities
that plague our health care system and result in these very
disappointing gaps.
I have cosponsored legislation, bipartisan legislation
entitled ``Closing the Health Care Gap Act.'' I think we need
to continue to work together to eliminate these disparities. My
question focuses on that. As Secretary, what actions can you
take to build upon the administration's record during the past
4 years and work toward a day when such disparities will truly
be eliminated?
Mr. Leavitt. Senator, I share your concern and your feeling
of inequity when I see that health outcomes are different, both
in a defined way, and predictably among certain groups of
people, particularly ethnic differences. I would mention two or
three things. The first is best practices. The use of
technology to assure that best practices can be deployed across
the board at every hospital when they are known, and that is a
function of technology and providing a means by which best
practices can in fact be delivered. Second would be the
disparities that exist in health coverage. I mentioned earlier
my belief that we can serve more of those who are currently
uninsured with the resources that we are currently devoting. I
passionately believe that.
I will use again SCHIP as an example. One of the brilliant
things that I believe that Congress did in writing SCHIP was to
give the States the capacity, if they chose, to develop their
own plan, both benefits and administration, as opposed to
requiring them to fall under Medicaid. In my State--we were one
of 13 who did so--and we were able to provide basic health
care, the same health care essentially that my children
received while I was governor, for nearly 30 percent more
people than if we had had them on Medicaid. That to me
demonstrates that we can deliver basic health care to more
people using the same resources. Many of them fall into the
categories that you have spoken of, either because of their
geographic location or their ethnicity.
Senator Frist. Thank you, Governor. I think what you
pointed out in terms of the flexibility required, that not all
populations are the same. We used to think of health care
disparities as just being straight out racial inequities,
disparities, which is a huge and important component, but part
of it is socioeconomic. I think of the Appalachian Mountains in
Eastern Tennessee, and every State is a little bit different. I
just want to encourage both this committee, in working with
you, with your leadership, to make real progress on these
issues.
I have been in the Senate now 10 years and very early on we
had to define those disparities. Now I feel like we have them
defined, and now is the time, through an approach such as you
mentioned, first of all recognizing the emphasis, providing the
appropriate resources, and as you said, having the flexibility
of being able to go to different areas, targeting different
populations, and adjusting accordingly. Thank you, Governor.
Mr. Chairman, thank you.
The Chairman. Senator Alexander.
Senator Alexander. Thank you, Mr. Chairman. I am glad to be
here to say how proud I am of Governor Leavitt's nomination. I
have made a habit for the last 30 years of watching governors
in other States, and there have been a handful of what I would
call transformational governors, those who have understood
their State's uniqueness and celebrated that and found ways to
actually change and improve it to transform it. Governor Dupont
was one of those, Governor Engler, Governor Thompson was one of
those, and Governor Leavitt was one of those. I think for him
to come to this Department at this time, especially when the
Medicaid challenge is going to require finding ways to take the
available resources and give States as much flexibility as
possible, and meet the needs, entrusting them to do that is
very important. Understand that at governors' meetings, people
do not sit around and talk about, ``I can do it worse than you
can do it.'' They sit around and talk about it and say, ``I can
do it better than you can do it.'' That is what the competition
does.
So, I am delighted you are here. I want to thank you for
your work with the Environmental Protection Agency and for your
efforts to pay attention to the air pollution we have in the
Great Smoky Mountains of East Tennessee. You have taken some
steps which I hope will take us even further.
I want to ask these questions. You have talked some about
the States, and I have confidence that you will pay attention
to the States. Senator Frist and I are very aware of what is
happening in Tennessee. When I left the governor's office in
1987, 51 cents out of every State tax dollar was being spent on
education, 14 cents on health care. Today it is 40 cents on
education, instead of 51, and 26 cents on health care, going
up. We are not going to have any first class universities or
excellent schools in our State if the State cannot afford to
fund them. So the governors need that flexibility.
I want to move on to another area that you have had some
background in in your work as Chairman of the National
Governors Association, and that is to look at early childhood
education, early education. In another hearing with Dr.
Condoleezza Rice this morning, it was pointed out that her
parents, in the segregated town of Birmingham, made sure she
had music lessons from the day she was 3-years-old, and they
recognized her talent. There are 69 Federal programs already
existing which spent 18 to 21 billion dollars other than
Medicaid on behalf of early education for children, and several
of those are in your Department. Those are programs that, not
just Head Start, which we often talk about, but the Child Care
and Development Block Grant is another one of those programs.
The programs that you have in your Department, although there
are only six, are 15 of the 18 to 21 billion dollars that have
to do with early childhood education.
So what I would like to do, working with the chairman, is
to use our oversight responsibility in this committee, and take
a look at the Federal dollars that we are already spending on
early childhood education, and find out where we are spending
it well, where there may be gaps, and then report to the full
committee and to the Congress about what else we need to do.
What are your thoughts on what you might do in your new
position when you are confirmed to help Senator Enzi, Senator
Kennedy, me and other members of this committee, to take a look
at the dollars we are already spending on early childhood
education and suggesting to us where needs exist and how we
might be able to improve that through legislation?
Mr. Leavitt. Senator, I have strong feelings, as I know you
do, about the importance of dealing with this problem and
dealing with it soon, because there are generations of children
who are not being as well served as they could by a
proliferation of programs. We do make a substantial investment
in this country. As you suggest, maybe it should be greater,
maybe it is adequate, but it is not as well coordinated as it
should be. The number of programs--I will use in my own State--
that do not coordinate, many of them serving the very same
children. I would simply say providing the flexibility so that
there could be on a State-by-State basis a commitment for
better coordination and delivery of services in a fashion that
looks at the whole child and not simply programmed needs.
Senator Alexander. Thank you, Mr. Chairman.
The Chairman. Thank you.
Senator Burr.
Opening Statement of Senator Burr
Thank you Mr. Chairman, it is a pleasure to be here today
for this committee's second nomination hearing of the year.
Mr. Leavitt, thank you for being here. I am aware of your
impressive work as the Governor of Utah and, more recently, as
the Administrator of the Environmental Protection Agency. Under
both jobs you demonstrated an excellent ability to manage and
improve the lives affected by your position. We will be
fortunate to have you as our Secretary of the Department of
Health and Human Services.
As you are aware from your tenure as the Governor of Utah,
the issues you will be responsible for at the Department of
Health and Human Services are broad and complex. Our Nation's
health care system is at a critical point and decisions by HHS
will determine our path and the wellness of Americans in the
coming century.
I sincerely believe that without cures for several chronic
diseases, including diabetes, and a serious focus on
preventative health care, we will not be able to stop our
health care delivery system from hitting a brick wall. As a
government, we must not pass laws or create an environment that
hinders medical device and pharmaceutical research on new
technology and medication, which can greatly impact quality of
life. It is only through that important work that the world
will be able to cure diseases that we currently can only treat
as chronic conditions.
As a government, we must also help every American access
affordable health insurance. But it needs to be smarter health
insurance than what is currently available to most Americans.
Smarter health insurance would allow individuals to be true
participants in accessing and managing their health care needs.
Individuals would be more knowledgeable and they would see the
long-term benefit of preventative care; not only with their
family budget in mind, but from a quality of life perspective.
Depending on individuals' situations, sometimes community
health care centers are the best health care access point. I am
very proud of North Carolina's community health care centers
and as a Member of Congress I worked hard for the last 10 years
to provide community health centers with necessary resources
and assistance. Not only should the President continue his push
for more community health centers, but he should also encourage
existing centers to follow Greene County, NC's lead and
implement electronic medical records and telemedicine
capabilities throughout community health center networks.
These are very broad, but important goals. While we strive
to reach these goals, we must also deal with the day-to-day
threats faced by this country. Outgoing Secretary Tommy
Thompson did an excellent job jumpstarting bioterrorism
preparedness at HHS. I will look for you to continue his
dedicated work in that area. The only way we can continue to
work on our long-term goals for this country's health care
system is if our Nation stays safe and secure from bioterrorism
threats.
Mr. Leavitt, I look forward to asking you some questions
and working with you in the future.
Senator Burr. Thank you, Mr. Chairman.
Governor, welcome.
Mr. Leavitt. Thank you.
Senator Burr. And indeed a thanks to you for your
commitment to public service, for the incredible leadership you
showed at EPA, and most importantly for the creativity to
problem solving, not only that you showed as governor, but in
the administration. It is, I am sure, not easy to say no when
the President calls, and I think that your commitment to do
this shows how wise the decision was by the President in
seeking you to come to HHS.
My first opportunity to meet you was in 1995 when you
testified in front of the Energy and Commerce Committee. At
that committee hearing you talked about States needing more
control over Medicaid. Let me ask you, today do you still
believe that that is the case?
Mr. Leavitt. Senator, I have deep, and I believe well-
informed views that it is even more true today. We continue to
see Medicaid escalate as a function of American investment. It
is broadly now known, but I will say it for emphasis, that this
year our expenditures on Medicaid will exceed our public
expenditures in States on education. When I became governor 12
years ago, that was not even close. But our expenditures
continue to rise, and our capacity to meet other demands
continues to diminish.
I believe we have substantial obligation to care for the
poor, but I believe that we can expand the number of people who
are served with quality basic care by allowing additional
flexibility and assuring that we have a partnership where both
partners are putting up real, making real commitments and using
real dollars to fund them. This is an important part of what I
believe will become the larger medical debate in this country
over the next couple of years. We could and should use Medicaid
as part of a transformation movement in the delivery of health
care generally.
Senator Burr. I certainly agree with you, and I think
members would not serve on this committee if there was not a
passion for health care, and I am sure you would not be at HHS
if there was not also a passion on your part.
A personal concern is that we are moving from what has been
up till this point a debate about affordability, and that the
lack of solutions on our part means that we will very quickly
be faced with an accessibility problem from the provider
standpoint. We will feel it first in the rural markets and then
it will spread to the urban markets.
Let me shift if I could over to SCHIP and follow up on
Senator Kennedy's inquiry. When we wrote SCHIP it was the
intentions of that legislation that States that did not use
their allocation, that that money would then be freed up for
the States that had fully implemented the money that they had
available. North Carolina would have been the beneficiary of
additional funds because we did an excellent job at SCHIP
enrollment. I am not asking you to be a prophet as it relates
to the budget or to the disposition of this money. But are we
at a situation where States who do excel should have an
incentive to grow the population even bigger?
Mr. Leavitt. As you suggest, Senator, there is an ongoing
budget discussion about what the disposition of those dollars
should be, and I am going to leave that between the Congress
and the White House. I will tell you this: that whatever amount
of money is allocated to SCHIP, I can assure you it is having a
profound and important impact, and to whatever extent HHS has
an opportunity to administer money, we will assure that it is
done in a way that will reach out, find those populations of
children and provide them with basic health care.
Senator Burr. Thank you. Last question. Senator Alexander
talked about the academic institutions and their need to stay
vibrant. One of the areas that is beneficial across this
country today is the extramural research dollars that come out
of NIH. Tell me if you can, do you see a growth in the
extramural side versus the intermural side at NIH, and which is
more beneficial to the long-term breakthroughs in this country?
Mr. Leavitt. Senator, I do not know the answer to that. We
were dealing with that same question at the Environmental
Protection Agency, who has an extended research and laboratory
capacity, and the issue was should we do it inside or do it
outside, and it was clear to me that there needed to be a
healthy dose of both. The balance of it at NIH is not something
I am in a position to make a knowledgeable suggestion on, but I
am very well acquainted with the pressures, the debates and the
tension, and I feel some confidence, if confirmed, that I will
be able to work through that with you.
Senator Burr. Thank you, Governor.
Thank you, Mr. Chairman.
The Chairman. Senator Isakson.
Senator Isakson. Governor, welcome.
Mr. Leavitt. Thank you.
Senator Isakson. I have to tell you, last night when I got
on the airplane about 8:15 to fly to Washington, much to my
surprise, I sat next to the former director of the Department
of Medical Assistance in Georgia, an old friend of mine, Russ
Towles, who in the course of the conversation I told him where
I would be at 10 o'clock. He said, ``Well, you tell Governor
Leavitt that he is the best choice the President of the United
States could have possibly made.'' He is a big fan.
Mr. Leavitt. Thank you.
Senator Isakson. Because he said that, and it gave me a
great opening, I decided I would ask him, ``Well, if you could
ask the Governor any question, what would you ask him?'' And he
was very complimentary of what we did in the Prescription Drug
Medicare Modernization Bill, but he asked the question, in
Medicaid there is a rebate program on pharmaceuticals based on
volume. As you implement through this year the prescription
drug plan for Medicare beneficiaries, can we do the same thing?
Mr. Leavitt. Senator, that is a well-informed question, and
one that I am not sure, given the limited exposure that I have
had at HHS on the nature of it on this side of the equation,
that I am in a position to really knowledgeably respond to. I
will tell you that, again, as a question we referred to
earlier, these are tensions I am very well acquainted with,
having dealt with them as governor, and my experience has been
there is a balance that has to be found. We have to provide
means by which we can create both the incentives necessary and
the economic structure for continued innovation. At the same
time people deserve to have safe pharmaceuticals, to have them
delivered in an innovative way, and to do it. I would seek
balance. I do not think I can give you an answer beyond that. I
am just not well acquainted enough yet with the issue.
Senator Isakson. Well, as you work on it, I will be happy
to work with you. I supported the program. I think it is a
brilliant move in terms of the future of health care
pharmaceutical coverage for seniors. In the long run they
actually save us money over the higher cost of hospitalization
and more intensive care.
Second, as Governor of Utah your use of technology was
nothing short of tremendous, in distance in your education
department, which I am familiar with, and other areas. I want
to go back to what Senator Kennedy said and Chairman Enzi,
talking about health information and using technology. It seems
to me that as we have spiraling costs of health care, one of
the embedded costs that is growing is the paperwork cost and
the redundancy of doing the same thing over and over again
almost to the level of insanity.
I mean I recently made two trips to the doctor, and it is
after January, so I filled out health information forms ad
infinitum, which could have been available on a health ID card
that could be just as secure as my ATM card. And I know you
indicated earlier, and I want to applaud you for it, we need to
work as far as we can. That is one component of the cost of
health care, that it seems to me we could foster quickly to
help bring down some of the costs and actually improve the
qualify of both information and care for those who receive it.
Mr. Leavitt. Senator, I have heard estimates that range as
high as 20 percent, that there could be 20 percent additional
efficiency, and I believe them. It is everywhere I look in the
health care delivery system. I do not think there is a person
on the planet who has not dealt with a health care issue.
Last night I was looking through a medical bill of mine on
a medical device that I bought in July, and I have, first of
all, found that the health insurance company was charged $900
for this device. I could have bought it online, the same device
and the same person for $400. We have been going back and
forth.
There is a more efficient way to do this, and it all comes
down to technology and coming up with interoperable systems.
This is a problem that the entire economy is going through. We
have come through a period of industrialization. We have gone
through the information age. We are now moving into the age of
interoperability. We have learned to make machines work
together. Now it is can we get the people to work together? Can
we find systems from Government agencies and private providers
and hospitals and physicians, and cause them to work together
in a way that will create that efficiency?
This is a complex, demanding problem, and I believe there
is an entirely new set of skills that we are having to learn as
a society, but the efficiencies are there to gather. I believe
we can and must pursue it because it is not just a function of
good health care. It is a matter of economic competitiveness as
a nation when 15 percent of our entire gross national product
is being consumed in health care services. Unless we are able
to do it efficiently, it could become a drag on our
productivity as opposed to the boost that it can be.
Senator Isakson. Thank you very much.
My time is up, Mr. Chairman.
The Chairman. Thank you.
Senator Hatch.
Senator Hatch. Thank you, Mr. Chairman.
Governor Leavitt, as you are well aware, Utah is a State
where we have tremendous capacities in health care, medical
device companies, pharmaceutical companies, and many, many
dietary supplement companies as well.
There are some in this town who believe that supplements
are unregulated, which I hope you know is absolutely not true.
We gave more power under the Dietary Supplement Health in
Education Act than previously existed to the FDA. Now, many
also believe that you will go easy on supplements because of
our home State connection, which I also believe is not true; I
believe that you will implement the law as it should be
implemented. That is my understanding.
Mr. Leavitt. Senator, your assumptions are correct.
Senator Hatch. The law in this area is tremendously
complicated, and I will not put you on the spot today by trying
to pin you down on anything. I just want to note that the past
two commissioners and the acting commissioner, I believe, agree
with me and Senator Harkin, that the law is adequate to take
care of those supplements that may pose a concern, be it a
safety concern or one related to labeling or content.
Now, when you come on board, it would be well if you could
speed up the Good Manufacturing Practice Guidelines that we
approved well over 10 years ago, or I should say were
authorized by law over 10 years ago, and which have been held
up for several years. I think it is critical to that industry
that this organization that you are going to head take care of
that. I believe they are almost ready to be published now.
But on a more general note, I wanted to put these concerns
on record, and I will be asking for your viewpoint in coming
months as you assume the reigns of HHS, but if you want to make
any comments now, we would love to hear them.
Mr. Leavitt. Senator, I think your statements approximate
my own views. It is clear to me that we have an obligation to
assure safety, but at the same time to provide innovation and
choice. And while my approach will be rigor, I also recognize
the value that is there and the fact that much thought has been
given to it, and I will look forward to working with you.
Senator Hatch. Thank you. Well over 10 years ago, I think
Senator Kennedy and I passed the FDA Revitalization Act, which
was to create a central campus for FDA with State of the art
equipment and a place where we could attract some of the top
scientists in the world to come and help us with this very,
very important organization that handles upwards of 25 percent
of consumer products in America. December of 2003 we dedicated
the first building. We now have FDA and some 30 plus buildings
all over this area. Some of them are converted chicken coops,
and without the best equipment in the world and so forth, I am
asking you to really push the revitalization act. I think had
we immediately started when we passed the bill, it probably
would have cost us a billion dollars. I think it is now
estimated to cost us about $3 billion. But the importance of
that is to be able to reduce the safety and efficacy time at
FDA so that drug prices will come down, while giving the people
at FDA the very best tools and facilities to administer the
programs.
So I am hopeful that you will be one of the most dynamic
pushers of this, and I do compliment Tommy Thompson for the
work he has done not only here but in other areas as well. But
I would appreciate your help on that.
Mr. Leavitt. Thank you, Senator. I will look forward to
working with you and others on it.
Senator Hatch. Thank you. As one of the original authors of
the Ryan White CARE Act, I am interested in what direction the
Agency will be taking on domestic and international AIDS
policy. So this is also an area that I know you are going to
get into and I know that you can play a dramatic and I think
constructive role in this particular area. Our country is the
leading country in the world in trying to resolve these
dilemmas, and hopefully we can live up to what the President
said we would do for the rest of the world.
There are so many other questions I have, but I will wait
until the second round before I ask them. Thank you so much.
Mr. Leavitt. Thank you, Senator. I will just comment that I
am aware of the President's commitment to invest up to $15
billion, and I know both his commitment to do it and his intent
to see it carried out.
The Chairman. Senator Gregg.
Senator Gregg. Thank you, Mr. Chairman.
Governor, I greatly appreciate your public service. It has
been extraordinary for many, many years. I do have a number of
specific questions I would like to ask you. I will start with
the FDA Commissioner. FDA is regrettably an agency that has had
some serious issues recently. It has always been a premier
agency in this Nation, something that the American people can
take great pride in. When they walk into a grocery store or a
drug store, the products that they get are protected and the
FDA has played the major role in doing that.
Since it is an agency in crisis, can we expect to get an
FDA Commissioner nominee up here before the end of this month?
Mr. Leavitt. Senator, I share with you the view that the
Agency needs permanent leadership, and if confirmed, I give you
my commitment I will press hard to see that that slot is filled
on a permanent basis rapidly.
Senator Gregg. Does that mean before the end of the month?
Mr. Leavitt. As you know, that is a decision the President
of the United States makes, and what you have is a commitment
from me that I will do all I can to see that it occurs, and it
is my sense that it will happen soon.
Senator Gregg. Obviously, we are facing a difficult budget
situation. The Medicare Modernization Act has been passed. When
it was proposed it was stated that the drug component of that
would be a $400 billion item over 10 years. The majority--not
the majority, but the plurality, the most significant element
of that spending actually goes to subsidize corporations, the
purpose of which is to keep them from shifting their drug
burden over to the public sector. It is now estimated as a
result of anticipated usage of that section of the bill by the
administration actuary, that the drug program will cost
approximately $555 billion. That is an increase of almost 40
percent, and I suspect it is an underestimate, even though the
program is not even in place yet.
I am wondering if the administration will be sending up to
us directions as to how to bring that program in line with the
original $400 billion estimate, or is it the administration's
position that $532 billion, which is what the administration
actuary actually estimated this to be, is a reasonable number
now, and $400 billion is no longer the cost of the program over
10 years?
Mr. Leavitt. Senator, I suspect if I am confirmed I will
have an opportunity to answer that question in a more informed
way than I can today, given the fact that I was not part of
that discussion, nor have I been part of their discussions on
forward-leaning budgets. I do not know the answer to it.
But I am aware of the responsibility to implement the
program. As I indicated earlier, it will be the main event at
HHS during the year 2005. The expectations are very high. The
timeframes are very short.
Senator Gregg. Let me just cut in. My time is limited. Do
you expect to implement this program within the price that was
estimated for the Congress, which was $400 billion, or do you
expect this program to exceed that number, as estimated by your
actuaries?
Mr. Leavitt. Senator, I am just not in a position at this
moment to know because I have not had briefings on the estimate
that was made originally. I am aware of the controversy. I am
aware of the fact that the cost estimates have changed, but I
am simply not in a position at this moment to know because I
have not been at HHS. When I do, I will be very happy to be
responsive to your question.
Senator Gregg. Well, let me ask you another way. Would it
be your intention to implement it under the terms as it was
passed, or would it be your expectation to exceed the original
number of $400 billion?
Mr. Leavitt. It has been my practice as a manager to
operate within my budget.
Senator Gregg. That would be great. That is exactly what we
need in that area.
There is another element of that bill which is sort of
interesting, which is that it did not allow the Federal
Government to negotiate prices with drug companies, something
that the Veterans Administration is allowed to do, something
that the State of New Hampshire is doing. I do not know if Utah
has that program. Do you believe that the Federal Government
should be able to negotiate drug prices to benefit seniors
under this Medicare program?
Mr. Leavitt. I believe that the best way in which to keep
drug prices competitive is to have a rigorous and active
market, and that the best negotiation would be between those
who are providing coverage and those--rather, those who are
providing the care, and those who are manufacturing it. I am
aware that there are cases in which the National Government, in
the case of the Veterans Administration and other situations,
or in some cases State Governments, are the providers of the
care, and in that case it is an appropriate thing for them to
be negotiating. I do not believe it is a good role for the
National Government to be providing as the setter of prices,
and there are ways in which I believe if we become the so-
called negotiator of prices, we are actually setting prices,
and I think a market does a better job of doing that.
Senator Gregg. Thank you.
The Chairman. For our second round of questions, I know
that you have a rural State and that you recognize that Wyoming
probably has the smallest population in the United States, and
I am concerned about the HHS grants. Our population is so small
that the dollars wind up correspondingly small, and by the time
we take care of the regulation and the administration necessary
for the regulation, we do not have much left to provide any of
the assistance, and I would like to see much greater
administrative flexibility for rural grant recipients, and I am
hoping that you will work with me on that as we get into
legislation and as you can do it administratively.
Mr. Leavitt. Senator, you will find me to be sympathetic
with that view.
The Chairman. Thank you. I also have some concerns, as I am
sure everybody does, over what the medical liability crisis can
add to medical costs and the ability to have access and quality
programs. I have drafted a bill that provides for some other
mechanism, such as an early offers, demonstration program, and
some special courts demonstration program, and I hope you will
take a look at that. And as I mentioned before, I hope you will
hold some informal sessions with members of the committee that
are willing to take the time to sit down and discuss some of
these things so that we can come up with the best plan
possible.
Mr. Leavitt. This is a subject on which I both have
experience and passion, and I know that the President has set
this as one of his most important priorities, and I will look
forward to being a participant in that conversation.
The Chairman. Thank you.
Senator Kennedy.
Senator Kennedy. Thank you, Mr. Chairman.
Governor, I listened carefully to these questions of
Senator Isakson and Senator Gregg about negotiating these costs
in price, and this is a hornets nest. We have a very divided
Senate on this. We have seen, as you pointed out, in the
Veterans Administration where we have seen dramatic reductions
in terms of the costs as compared to others. Many of us believe
that Medicare ought to be able, or you ought to be able to at
least be involved in those kinds of negotiations for the
benefit of the seniors to lower prices. That is for a different
time, to debate that. Negotiating rebates is an authority that
the Secretary does not have at this time that many of us
believe you should have in order to lower costs.
I appreciate the mentioning of the AIDS relief at $15
billion. I appreciate you mentioning that. I hope you will look
again at what percent of that $15 billion is being used to pay
for generic drugs and what percent is being used for the high
cost drugs. You will find out that because of the influence of
the drug companies, that the greatest percentage is the higher
cost drugs. Many of us believe that they could have greater
kinds of impact in terms of peoples lives with generic drugs.
That is a policy issue I know you will want to visit with. I do
not want to get into that at this time.
I want to underline the importance of a new Director for
FDA. The last 4 years we have had one Director, Mark McClellan,
who was superb. But it has been vacant. We have had an Acting
Director. That is not right for that Agency. I mean my State,
like other States, has a very active and involved
pharmaceutical industry and a biotech-industry, and they as you
would well understand, want to be able to get decisions that
are going to be lasting and effective so that they can plan,
and they just cannot get that. And I join with Senator Gregg in
urging that we get that position filled. There are a number of
enormously gifted and talented people outside the industry that
can do the job and have our confidence, and I hope that that
can be done.
I listened to my friend, Senator Hatch, talk about the diet
supplements, and I know his strong view about it, except we
have had the experience of ephedra that was taken off the
market but it took a long time to get that off, and it was a
real health danger, so having the top person over there at FDA
to be able to do the job is important. The bill is quite
specific, as Senator Hatch pointed out, but there are issues
that are involved in it.
I want to just cover two issues very quickly. One is
affecting my State and that is LIHEAP. We have 671,000 families
in Massachusetts eligible for LIHEAP, and only 146,000 families
receive LIHEAP funding, so this is about 1 in 5 families that
are receiving it now. Massachusetts used up the entire $7
million released in December. We only had enough to cover about
20 percent of the estimated families without emergency funds,
and there is no help now for anyone. There is wind chill of 2
below in Massachusetts, been there, well, for the last 4 days.
There is $200 million in LIHEAP emergency funding at HHS, and I
would hope that--we are going to do all we can to get you into
that office, and I would hope at least you would look at this,
not just for Massachusetts but for other hard-pressed areas. We
have a number of States.
Mr. Leavitt. Thank you, Senator. That is both noted, and I
will follow on it, and give you what response----
Senator Kennedy. If you can, as an early priority because
it is a real priority here.
Just finally, we had talked about what you had done on the
welfare in Utah. Utah's program is flexible in dealing with a
number of barriers. Treatment services count as TANF
participation. Mental health and substance abuse. Counselors
are available in TANF offices for short term counseling, or for
long-term treatment concurrent with employment. Some have
disabilities, others are caring for sick children. You have had
really important flexibility in responding to enormous human
needs. I am wondering whether this would be your position, to
support those kinds of efforts in our deliberation of this bill
when it comes before the Senate? I know the administration is
going to speak to this, but I would be interested in your own
experience about the effectiveness of the programs and what you
might hope would be in legislation that we would consider along
these lines.
Mr. Leavitt. Senator, I will just say that I have had
occasion as Governor to sit at the table with a person being
counseled and to work through the entire process with them. I
know that it is a process of essentially helping a person put
their life back together. In most cases it has been a hardship
and they have some short-term problems they have to deal with,
and often it is a matter of doing something simple.
I remember one case where we, rather than put them on to
the whole program, we just needed to provide them with some
steel-toed shoes and help them with some other kinds of things
that otherwise would not have been--under the old program we
would have had to put them on welfare for several months, but
we were able to solve the problem. They went to work, and it
was a good thing for them. So I found flexibility in dealing
with the individual needs is a very important part, and I would
hope we could preserve that and what I think is a great
American success story.
Senator Kennedy. May I have one last one? My time is up,
and I thank the Chair. On the flexibility in the waiver, we
have had now with the changing of the administration--
Massachusetts had a waiver for the last 8 years on Medicaid. We
have saved Medicaid $1.8 billion. It was always used for health
care issues--Medicaid. Governor Romney has been down seeing
Thompson. That part has been worked out, and as a result of it,
our Governor is going to have a lot less flexibility than he
would have had previously.
So I know this point that has been made here in terms of
the flexibility, we have seen in our own State where we have
had the waiver and it has been done under Republican and
Democratic Governors, been done very, very effectively in terms
of the purposes of Medicaid and the savings that have been
provided. So you are going to have a different kind of
framework to operate in, but I just wanted to add that.
I thank the Chair very much for his indulgence.
The Chairman. Thank you.
Additional questions, Senator Isakson.
Senator Isakson. Just one, and a comment. One of the
largest contributors to the rising cost of health care for
those who are covered in terms of the cost of their insurance
and their co-payment is the rising cost of the uninsured. The
CHIP program--and you did a great job in reaching out to get
those children insured who were a large number of the uninsured
in Utah. But do you have any suggestions as to what you would
recommend or think we ought to focus on to try and increase the
number of insured and decrease that burden on the number of
those who are insured and paying at higher rates?
Mr. Leavitt. Senator, I do have, and I want to describe
something for you that I do not intend to imply as a solution
on a national basis. But it troubled me greatly that we had
400,000 people in our State who did not have any health care
insurance at all. In my State, if you want to have the richest
health benefit program, you will go to Medicare. It is about
143 percent in terms of benefits of what a person would earn if
they went to work at a car dealership or a mill. If you want
the second richest, you go to Medicaid. It is about 139
percent. Or at least those were the percentages when I was
dealing with this.
We went through a period of time, a very difficult period,
like most States, where we were simply pressed to balance our
budget, and we actually had to reduce benefits for vision and
dental on a small population of our Medicaid recipients. I
noticed today in the paper that the new Governor has money now,
and he is going to go put those back, and I am glad for that.
But at the same time, we concluded what if we were to have
that program on Medicaid not be 139 percent richer but what if
it were only 125 percent richer and we were to take those
dollars and provide a benefit to people who are without
coverage at all. I got a waiver from HHS. We now have 18,000
families who are working at one or two or three jobs, who had
no health insurance, who now have it. We took the same dollars.
We provided them with health care, frankly, that was not the
kind of health care we would aspire to have them receive. But
they have health care. They have basic health care. We used our
community health centers to provide it, created a policy that
provided preventative care, basic health care. The community
got together. It was a very solid success, and we are learning
from that.
So I do not represent it to be the wave of the future. I
simply just hold it out to be what it was: an effort on our
part to take limited resources and to provide basic health care
to all of those who don't have it.
Senator Isakson. Well, it is a good example of why you are
the appointment of the President, too. It is thinking outside
the box, and I appreciate that.
I just have a comment, Mr. Chairman, and that is, you
cannot come from Georgia and talk to the future Secretary of
Health and Human Services without thanking him for
acknowledging CDC's brand and making the statement that the
Congress and the President during the last 4 years have done a
remarkable job in funding the new construction, the laboratory
work, and the hardening of what is really the world's public
health asset. And I appreciate very much your acknowledging
that, and I look forward to working with you to continue to
grow CDC and its capability and its reach around this country
and around the world.
Thank you very much.
Mr. Leavitt. Thank you.
The Chairman. Senator Dodd.
Senator Dodd. Well, thank you, Mr. Chairman. And, Governor,
welcome. I apologize for being late. Dr. Rice is appearing two
or three floors up before the Foreign Relations Committee, so
it is one of those mornings where we are sort of scurrying back
and forth. I apologize that I was not here for your opening
comments.And I gather a number of my colleagues here already
have gone into some detail, Mr. Chairman, on Medicaid funding
and other questions, so I will rely on that record.
I should point out, Mr. Chairman, that my family, the side
that I married into is a Utah family, and so I am very much
aware of Mike Leavitt and his stewardship of that State. When I
go out for family holidays, I am often called the third Senator
from Utah. And those ten Democrats out there deserve a Senator.
[Laughter.]
My good friend Orrin Hatch likes to tease me about that.
Senator Hatch. We are very proud to have you. However, we
could suggest some changes.
Senator Dodd. I think now you could. I have suggested
several for you along the way.
Senator Hatch. You have.
Senator Dodd. Neither of us has had any success in that
regard, I might point out. But I always enjoy going out to Utah
and seeing my wife's family out there. So it is a pleasure to
have you before the committee.
Let me raise a couple of questions. One, I mentioned my
good friend Senator Hatch because one of my proudest moments in
this body over the last quarter of a century occurred almost 20
years ago, when Senator Hatch and I, along with many others,
initiated the concept of the Child Care Development Block
Grant, which was a revolutionary idea in its time to try and
assist working families particularly who were struggling, as
you have just pointed out, many of them single parents, or
intact families with both people working trying to make the
economics work, with young children, and the importance of
having a quality, safe, available child care structure that
would allow them to be able to do what they had to do and know
that the individuals they care most about, their children,
would be under safe quality conditions.
But we have had an awful problem over the last number of
years in the freezing of funds, and as a result we now have
some 600,000 children who are on waiting lists all across this
country waiting to get into a decent child care setting. Too
often the parents are relying on the worst of circumstances for
these kids, and we need to do something about it, clearly, as
we move forward on welfare reform. And you will be asked to
play a major role in that.
And so what I would like to ask you this morning--I do not
expect you to lay out anything in detail at this point, but we
need to sit down, if you could, with those of us up here who
have worked on this issue over the years--and, again, I want to
thank my colleague from Utah. He was just invaluable to
understanding this issue early on, the importance and the role
that we could play at the national level of being supportive of
our States and our families in this regard. But we need to sit
down--if we are going to move forward on a welfare reform bill,
we cannot have the working poor being pitted against those on
the welfare rolls when it comes to getting this kind of
support. If we end up reducing the child care assistance for
the working poor only for those who would be on the welfare
rolls, then we are going to find the working poor tumbling back
into the rolls of the very people we have been trying to move
out of that system into working relationships.
So I would hope that we could sit down soon, if we could,
with you and see if we cannot get some movement on unfreezing
these funds, in my view, and providing some additional
assistance as we move forward. And I wonder if you might share
some overall comments on that point.
Mr. Leavitt. I would be happy to, Senator. I had the
privilege, as you have indicated, of serving as Governor during
a period when welfare reform was enacted. When I began as
Governor, we had just under 20,000 families that would be
considered on welfare. When I left, there were about 7,000.
During the more difficult times, we saw that edge up, as we
should, because more people needed help.
But it was clear as we went through that process of helping
people realign their lives that it was unrealistic to send a
mother, a single mother with two or three children, off to work
without the capacity for her to have high-quality care for her
children. It was not in our interest or hers or the children's.
The good news here is that we have accomplished much. We
have been able to reduce the number of cases that we are
dealing with in the country. There are fewer people who are in
that circumstance than were before, and I feel optimistic that
we can find a solution to this because I think the principle is
sound. People need good-quality child care. The question is how
do we provide it. I would add my experience has been when you
sit down with people and actually get down to it, you just need
the flexibility to find a solution to their problem.
Senator Dodd. The affordability issue obviously is
critical. I do not need to tell you. Now, per child it costs,
and I am not exaggerating when I tell you this, between $6,000
and $10,000 per child per year. And you start with people of
incomes of $20,000, $25,000 a year trying to hold on to those
jobs with two kids, you do not have to have a Ph.D. in
mathematics to know it just does not work. So that is a
critical constituency. And I hope you will work with us and not
only ensure that child care is more affordable but also that
low income parents have access to quality care. It is very,
very important.
The drug safety issue has received a lot of attention.
Again, I gather, Mr. Chairman, we haven't spent a lot of time
on this issue, again a subject matter I know my friend from
Utah has a lot of interest in, but a lot of stories over the
last few weeks about the FDA and drug safety. We know of these
patients who have been hurt or killed by widely used pain
medication. We have heard those stories recently.
Several of us in Congress are considering legislation to
reform the Food and Drug Administration's approach to drug
safety and ensure the results of clinical trials are made
public. I wonder if you might comment, particularly on the last
point dealing with the public information, making available to
the public about these clinical trials and public safety.
Mr. Leavitt. I believe that the process of Government ought
to be conducted in the most transparent possible way, and when
it comes to drug safety, people do have a reason to expect
safety. We want it also to be--for industry and for Government
to be innovative. We want to have access. We want to have
independence in assuring that it is.
I recognize the tension that exists perpetually,
intuitively between wanting innovation and speed and at the
same time wanting safety. And sometimes those conflict. It is a
function of finding balance and getting better at it.
Senator Dodd. Well, I represent a significant number of
companies in my State, some 35,000, 40,000 people in
Connecticut are employed in the pharmaceutical industry, and
they are tremendous companies and they do a wonderful,
wonderful job in many, many ways. And it is also a great
source--we have a tremendous imbalance in trade, and our
pharmaceutical industry contributes significantly to U.S.
exports.
One of the reasons they do is because that stamp on it, FDA
approved, means so much all over the globe. That Good
Housekeeping Seal of Approval that these products are effective
and safe has been tremendous, first of all, on a human level
very important, but also economically. It is really important
we get this right early. If we end up with a reputation that
this very important agency is no longer reliable, I think it
would do great, great damage to a very important industry in
this country.
Now, I see time is--well, I have a couple more questions,
and I will be glad to wait until my colleagues go around, if
that is the way you are doing this. Are you, Mr. Chairman?
The Chairman. Yes.
Senator Dodd. Fine. I will come back.
Mr. Leavitt. Mr. Chairman, could I just make one brief
response?
The Chairman. Yes.
Mr. Leavitt. I referred earlier to FDA and CDC and NIH as
important brands. A brand is a promise, and if we ever lose the
value of that brand, the American people lose a great treasure.
Senator Dodd. You bet.
Mr. Leavitt. And I see the guarding of the integrity of
those brands as a fundamental part of this responsibility.
Senator Dodd. Thank you.
The Chairman. Senator Hatch.
Senator Hatch. Thank you.
Governor Leavitt, one issue that I think all of us are
deeply interested in--I certainly am--you know, is building up
our Nation's defense, especially against biological and
radiological weapons. Last year the Senate Judiciary Committee,
which I chaired at the time, and the HELP Committee, this
committee, held a joint hearing on how the 2003 bioshield law
may be improved upon and what Bioshield II needs to have
included.
Now, we need to encourage rather than discourage
pharmaceutical and biological companies to develop products to
help us combat bioterrorism. Unfortunately, current policy
discourages companies to develop these products. I think this
has to change. We have got to make headway in this area, and
knowing you, I am sure that you are the guy who can help do
this--not that people at HHS have not been trying.
I want the Department to work with us in developing policy
to address these very serious concerns, so I am hopeful that we
can work together to do this. I am working currently on
legislation with regard to this with my good friend, Senator
Lieberman from Connecticut. And so we would appreciate your
assistance on this.
I also want to thank my colleague from Connecticut, Senator
Dodd, who has been such a great leader on this committee, for
his kind remarks about me. It is a privilege to be back on this
committee and to work on some of these issues that I have taken
such an interest in. And I have to say for everybody, I know
you as well as anybody knows you, and I know what a great
policy person you are and how much you really do care about
getting things right and working them through. It is a
tremendous ability that not too many people have. But you do,
and I think you were recognized as one of the great Governors
in this country, as you should have been. And I know that you
have done a tremendous job over at EPA, which is almost an
incomprehensibly difficult job, especially for a Republican, to
do. And I think virtually everybody has given you credit for
doing that, and with aplomb and with dignity and with fairness.
Now, what I hope is that this committee will put Governor
Leavitt out quickly so that he can get busy and do some of the
things we all know he can do. And we have got to be very much
concerned about helping you. And I think this committee will
be, and I have been really pleased with the nice way you have
been treated here today by members of the committee.
Thank you, Mr. Chairman.
The Chairman. Thank you.
Senator Gregg.
Senator Gregg. Governor, have you had a chance to spend any
time--and I can understand if you have not, just moving over--
on this whole issue of how we revitalize the vaccine industry
in America? The whole concept of Bioshield was that we needed
to prepare ourselves for a biological attack, and we have no
significant domestic vaccine industry because most of our
vaccine industry had been pushed out of business by basically
trial lawyers. And so to try to create such an industry, or at
least incentivize people to move into this area, we passed
Bioshield I.
We have now seen the flu vaccine problem, which shows that
if you rely on a single supplier, whether domestic or
international--but obviously international raises issues, too--
you have got serious problems. And I am wondering how you are
viewing this issue of how we get, first, our domestic vaccine
business up and running, an enterprise up and running, what we
need to do beyond Bioshield I; and, second, how we expand, for
example, the flu vaccine purchasing process so that we use the
Canadian vaccines that are available and other international
vaccines that are available and not find all our eggs being in
one basket as they were?
Mr. Leavitt. Senator, this was an obvious area of interest
to me given the fact that we are moving into the flu season and
the prospect and the potential of being confirmed. Just a
couple of observations.
One, we cannot expect that we will have people stepping up
to manufacture unless there is a market. There needs to be a
market. Sometimes it may need to be the Federal Government to
make certain that there is a market.
Second, despite the fact that there has been substantial
work on the liability issues by the Congress, I suspect by this
committee, it is also clear to me that there remain some issues
that need to be resolved. This is a very serious problem and
one that in my judgment needs to be dealt with and dealt with
promptly.
Senator Gregg. Do you have any thoughts about whether we
should look for other suppliers from other countries besides
just the one we were using for the flu vaccine, such as
Canadian suppliers?
Mr. Leavitt. My thoughts have not matured to the point that
I could express them adequately or properly. I am aware of that
as a possibility. I am working to gather the information
necessary to form a viable opinion. I look forward to an
opportunity to talk with you about it.
Senator Gregg. There is a bill bouncing around the Congress
right now, which, again, you may not have had time to get up
on, called the Patient Safety Act, which is essentially an
attempt to give--which passed out of this committee
unanimously, passed the Senate, was held up in the House on an
ancillary issue which had nothing to do with patient safety.
Are you familiar at all with that bill?
Mr. Leavitt. By title.
Senator Gregg. OK. Well, anyway, I would hope that you
might have a chance to take a look at it at some point and see
if we could not encourage its passage. It will allow hospitals
and doctors to exchange information more efficiently, which is
a key part of this whole process of getting health care
delivered more effectively, and we hope that we can restart it
in this Congress in a prompt way.
Again, I thank you for your willingness to participate in
public service the way you have. It is extraordinary, your
career is extraordinary, and we are very lucky to have someone
like you being willing to take this position on.
Mr. Leavitt. Thank you, Senator. Could I just respond with
respect to the issues related to the extent--or the supplying
of information and interoperability issues. I do believe those
are issues that we will have to work together to resolve,
because much of the efficiency, much of the protection we seek
can be hampered until we are able to work through those very
thorny issues.
Senator Gregg. Well, you are absolutely right, and this
bill takes a fairly significant step forward in that exact area
in that it allows hospitals and doctors to exchange information
without putting the patient's information or the patient at
risk and do so in a way that gets around the competition
issues, which we have had problems with the antitrust issues,
and protects the doctors and the hospitals from arbitrary
lawsuits which would be brought as a result of an exchange of
that information. And that information will lead to a more
efficient delivery of service, and what it most importantly
will lead to is less medical errors, hopefully.
Mr. Leavitt. Yes.
Senator Gregg. Which is very important. That is why this
committee passed it unanimously. That is why the Senate passed
it on, I think, a voice vote. We are still wondering why the
House has not passed it.
The Chairman. Senator Dodd.
Senator Dodd. Thanks, Mr. Chairman. Just a couple of quick
other questions that I would just like to raise, if I may.
We pay a lot of attention obviously to drug abuse among
young people. The largest killer among these kids, though, when
it comes to substances, is alcohol, underage usage of alcohol.
The numbers are just staggering. About 7,000 kids under the age
of 16 today will take their first drink, and for many of them
it becomes a serious problem. In fact, we lose over 4,000--
close to between 4,000 and 5,000 young people every year in
deaths related to alcohol in this country.
Well, in 2003, the Institute of Medicine released a study
called ``Reducing Underage Drinking: A Collective
Responsibility,'' that laid out the national problems presented
by the consumption of alcohol by youth and established a
multitiered national strategy to reduce underage drinking's
toll. Sadly, there has been very little progress on this at the
Federal level in instituting this important report's
recommendations, and I do not expect you have had a chance
necessarily to become familiar with these recommendations, but
I would urge you to do so, if you could, so that we might begin
to talk about establishing national policy in this area.
I have had countless meetings with people from the
alcoholic beverage industry, and I must say many of them are
fully supportive of what we are trying to do in coming up with
some intelligent responses to this, including how they
advertise. And we all know the First Amendment issues, and the
industry has as a matter of its own decision refrained to a
large extent from advertising, at least on television and other
places. But, nonetheless, we have seen some real problems with
some of the efforts. Again, just watching any major sporting
event and you watch the advertising that comes on, too often
you see exactly what age group they are appealing to when they
are using Play Stations to advertise beer and so forth, as one
industry did. They have stopped it, by the way, but they
certainly did for a while. You get a clear indication of the
age group they are trying to appeal to.
There have been some very good recommendations in these
reports. Some of them may be a little more than the
administration and others may want to accept, but I think there
are some good ideas, and I would really urge you to take a good
look at this early on and see if we cannot take some good
steps. I think you will find a lot of cooperation up here. The
American public cares about it. Considering the loss of life,
the damage, the illness, the permanent damages to those who
don't lose their lives is just overwhelming. And so I would
urge you to become involved in it as early as you can. I don't
know if you want to make any particular comment.
Mr. Leavitt. Well, I would just comment that you indicated
early you have spent a fair amount of time in Utah, and as a
result you would know that that is a State that takes this
issue quite seriously.
Senator Dodd. Well, good. We hope you will do that.
This last one I want to raise with you is, again, an issue
that there is nothing like a personal experience, I suppose, to
bring your attention to an issue. Three years ago, my wife and
I had our first child and discovered when she was born that
there were only about eight newborn screening tests available
in the State of Virginia where she was born. Only one State
provided testing in 32 areas, which was the State of
Massachusetts at the time. We passed legislation to try to
increase support for additional newborn screening for these
newborns given, again, the problems that can emerge very, very
quickly with these kids.
There has been a report that has come out from the
Committee on Heritable Disorders and Genetic Diseases in
Newborns and Children--it is going to release a report, I
should point out, recommending that all States test for 29
disorders in these infants. We have had hearings in this
committee, very compelling hearings, where parents have come
forward and said had there just been some of those tests--they
are very inexpensive to do, but we need some additional
cooperation. The States would like to do a lot more in this
area. Some of the equipment necessary is not inexpensive, but
the cost of not doing it, I do not need to tell you, is
overwhelming when you look at children experiencing lifelong
disorders that require millions of dollars being spent in some
cases.
So it is another one of these areas that, again, I do not
expect you necessarily to be deeply familiar with the subject
matter, but it is one where we can, with a small amount of
effort, make a huge difference for people. And I would urge you
to take a look at this, and your staff, and see if we cannot
sit down and maybe talk about some ideas and how we promote
this expanded use of newborn screening.
Mr. Leavitt. Thank you.
Senator Dodd. Mr. Chairman, I thank you. I have taken a
little more time, and I appreciate it.
The Chairman. Thank you very much.
I want to thank all the members of the committee for their
participation. I want to thank Secretary Leavitt for his
straightforward answers and wealth of knowledge that he brings
to this job and the willingness to go through two of these
nomination hearings. We are not the primary committee, as I
explained before. As a result, the record will remain open for
10 days or until the Finance Committee takes action, whichever
is less. And we will be polling the members of this committee
on an appropriate question for our advice and consent.
With that, this hearing is adjourned.
[Additional material follows:]
Additional Material
Response to Questions of Senator Bingaman
The Uninsured
Question 1. The uninsured rate has increased from 40 million to 44
million people during the past 3 years. To put that in prospective,
that is equivalent to having every single person go from full health
coverage to nothing in the following places: Milwaukee, Wisconsin;
Memphis, Tennessee; Tuscon, Arizona; Albuquerque, New Mexico; Miami,
Florida; Pittsburgh, Pennsylvania; Des Moines, Iowa; and the entire
State of Montana. What steps will you take to reduce the number of
uninsured Americans, especially low-income pregnant women, children, or
those with chronic illnesses?
Answer 1. My experience as Governor taught me that there is no one-
size-fits-all solution to reduce the number of uninsured Americans.
Simply expanding eligibility for government programs may in fact
overlook market based solutions for the working uninusred. The Covered
at Work program is an example of a public-private parternship to help
low-income working families access the health insurance that is
available to them through their employer, but may be out of reach due
to the expense. The program provides subsidies for up to 6,000 Utah
residents who are not eligible for Medicaid but also struggled to meet
their share of the expense for employer-sponsored insurance. I very
much look forward to working with you and the Congress to advance the
President's multi-faceted approach to reducing the number of uninsured.
As you know, the President is committed to making quality health
insurance more affordable and more accessible for millions of American
working families. The President's plan will help reduce the rising cost
of health care; provide new and affordable health coverage options for
all Americans; and provide not just a government program, but a path to
greater opportunity, more freedom, and more control over your own
health care and your own future. For low-income families, the proposal
includes refundable tax credits to enable families to buy coverage. It
also includes $4 billion in Federal grants to States to establish
purchasing pools--or to expand existing pools--where people could use
their tax credits to buy coverage. In addition, he's proposed to allow
tax credit recipients to divide their assistance between a premium
subsidy and a government contribution to a health savings account. This
account, which they could use to pay routine medical expenses and to
save for future health care needs, would belong to them, not to the
government. These and other proposals would help reduce the number of
people who lack health insurance coverage.
Healthcare Workforce
Question 2. With 76 million baby boomers aging upward and the
average lifespan continuing to increase, the aged 65 and over
population is expected to double over the next 30 years. Our society
currently faces significant health care workforce shortages. What
strategies and actions do you foresee that will help to ensure an
adequate number of providers who are fully-trained and capable of
meeting the health care needs of an aging population, now and in the
future?
Answer 2. By continuing to focus on the problem of maldistribution
of health professionals across the country, we will help ensure that
the aging population has access to the health care they need. As you
are aware, HHS administers a successful program that specifically
addresses this issue ? the National Health Service Corps (NHSC). This
program provides financial incentives, through scholarships and loan
repayments, to health professions students and providers who agree to
serve in underserved areas. This program has supported more than 24,500
health professionals committed to service to the underserved, and
approximately 6 million people now have access to care from NHSC
clinicians. HHS also continues to expand the Community Health Center
program to ensure that affordable health care is available in
underserved areas across the country.
There continues to be a serious shortage of nurses across the
United States and a shortage of nursing faculty that is limiting the
number of students that can be admitted to schools of nursing. HHS
administers several programs that specifically focus on alleviating
this nursing shortage, including comprehensive geriatric education to
prepare nursing personnel to care for the aging population. Funding for
these activities has increased by 75 percent since fiscal year 2001.
The Department's efforts to ensure an adequate supply of health
care providers are guided by studies carried out by the National Center
for Workforce Analysis. This center continues to conduct studies that
help develop strategies to meet the health workforce needs of an
increasingly diverse and aged population. Over the past two decades,
HHS has invested over $6 billion in general health professions training
grants. HHS is in the process of compiling detailed information on the
effectiveness of these health professions programs and we will be sure
to share that information with your committee when it is available.
Question 3. Would you support a study examining the role of U.S.
medical schools in meeting the physician needs within the country?
Answer 3. I understand your concern about the lack of growth in the
number of students graduating from medical schools in the United States
and the increasing dependence on foreign medical schools in the
training of American medical students. The Department will continue to
monitor and evaluate the impact of the health professions programs and
the state of the health care workforce in general. From what I
understand, the fiscal year 2005 appropriation did not include funds to
support such a study, but if I am confirmed as Secretary, I will stand
ready to work with you to evaluate this situation.
NIH
Question 4. The scientists and researchers at the National
Institutes of Health (NIH) are responsible for cutting-edge medical
breakthroughs that are improving the lives of Americans every day.
Unfortunately, the value of their research has on occasion been called
into question outside of the agency. As Secretary of the Department
Health and Human Services, would you continue to support the peer
review process for NIH grants whereby researchers work is evaluated by
their fellow scientists?
Answer 4. Yes. The peer review process is the essential ingredient
that protects the integrity and value of research supported by NIH.
Plan B Emergency Contraception
Question 5. Last December, the FDA's Independent Expert Advisory
Committees overwhelmingly recommended approval of the Plan B OTC
application with a 23-4 vote. The committees were, however, unanimous
in their determination that Plan B is safe enough for over-the-counter
use, and that there is no data to show that Plan B leads to
substitution of EC for other methods of contraception. Despite the
Advisory Committees' review of hundreds of studies on Plan B, and that
recent research, including a JAMA study, continues to support the
committees' original favorable recommendation, the FDA denied Plan B
OTC status and overrode the overwhelming scientific evidence. Why has
the FDA delayed approval of this drug?
Answer 5. As you know, the FDA previously denied an application to
change this drug to over-the-counter status. I understand that FDA did
not approve a switch of this prescription drug to OTC status on the
first review of the application for two reasons. First, the sponsor did
not provide adequate data to support the conclusion that young
adolescent women can safely use Plan B for emergency contraception
without the professional supervision of a licensed practitioner.
Second, a proposal from the sponsor to change the indication requested
in their application to allow for marketing of Plan B as a
prescription-only product for women under 16 years of age and allow
non-prescription marketing to women 16 years and older was incomplete
and inadequate for a full review.
In July 2004, Barr Laboratories resubmitted their application after
FDA determined it could not approve Barr's initial application based on
the information submitted by the company. The Agency currently is
reviewing the resubmitted application.
Indian Health Service
Question 6. Despite double digit growth in health care spending in
both private and public sectors, the Administration's fiscal year 2005
budget submission for IHS includes just $45 million, or a 1.6 percent,
increase. This follows a 3 percent increase in fiscal year 2004 and a
2.5 percent increase in fiscal year 2004--none of which covered even
basic medical inflation. The result has been a dramatic decline in
spending power for the Indian Health Service (IHS) during the
Administration's term in office.
Consequently and not surprising, this disparity in funding
translates into severe health disparities for Native Americans. For
example, life expectancy is six years less than the rest of the United
States citizens. Tuberculosis rates are four times the national
average. Complications due to diabetes are almost three times the
national average and death rates exceed the Health People 2010 targets
by 233 percent. Infant mortality rates are 1.7 times higher than the
rate for white infants. These figures are both shocking and
unacceptable. What will you do to address the health disparities faced
by Native Americans?
Answer 6. Over the last 40 years, there have been significant
health improvements among Indian people related to control of
infectious diseases, expanded access to primary health care, and
fundamental community infrastructure such as safe drinking water.
Today, injuries, chronic diseases and behavioral related diseases such
as alcoholism, substance abuse and mental health have emerged as
leading challenges in Indian communities. One of the keys to addressing
these problems is ensuring access to health care. I look forward to
working with Congress and the Indian Health Service, which plays a key
role for the Department of Health and Human Services in providing
access to care to American Indian and Alaska Native communities, to
address these issues and reduce and eliminate health disparities. In
doing so, it is critical that the IHS identify and collaborate with
outside organizations with the capacity, capability, and interest to
assist in addressing these diverse health problems. The IHS has
developed partnerships and collaborations with other Federal Government
agencies as well as academic, professional and other non-governmental
partners. These partnerships cover a broad array of programs, including
on health promotion and disease prevention.
Question 7. The Indian Health Care Improvement Act is critical for
providing health care services to 1.6 million federally-recognized
Native Americans through IHS, as well as Tribal and urban Indian health
programs, and has been pending before the Congress for far too long.
Will you work to push for reauthorization of the Indian Health Care
Improvement Act (IHCIA)?
Answer 7. Over the last 40 years, there have been significant
health improvements among Indian people related to control of
infectious diseases, expanded access to primary health care, and
fundamental community infrastructure such as safe drinking water.
Today, injuries, chronic diseases and behavioral related diseases such
as alcoholism, substance abuse and mental health have emerged as
leading challenges in Indian communities. HHS, working through the
Indian Health Service, has a key role to play in working with American
Indian and Alaska Native communities to improve health conditions
through improved access to quality health care services, enhanced
health care promotion and disease prevention, and focuses on new and
emerging health issues facing these communities. The reauthorization of
the Indian Health Care Improvement Act, which Congress was
unfortunately unable to complete last year, could further support the
efforts of HHS and IHS in these endeavors. As Secretary, I look forward
to examining any reauthorization proposals and hope to work with
Congress on these critical issues.
Mental Health
Question 8. In July, 2003, President Bush's New Freedom Commission
on Mental Health completed its final report. Describing the country's
mental health system as one in ``shambles,'' the Commission documented
the crisis:
In the United States, suicide claims approximately 30,000
lives a year.
In the United States, about 2/3 of people with mental
illness are unemployed.
In 2001, parents were forced to place more than 12,700
children in the child welfare or juvenile justice systems in order to
get them mental health treatment.
More than 750,000 people with mental illnesses will end up
in jails or prisons over the coming year, most of them for nonviolent
offenses related to their mental illness.
And worldwide, mental illness is the leading cause of
disability worldwide, accounting for nearly 25 percent of all
disability across major industrialized countries.
Notwithstanding the urgency, the President has never endorsed the
Commission's Report or even acknowledged its existence. Nor has HHS
issued an action plan for implementing the Commission's
recommendations. What is the status of the Department's work on this
issue? Will you make mental health policy a priority?
Answer 8. The President's New Freedom Commission on Mental Health's
report, issued in July 2003, called for profound change and
transformation of the current system, recommending new service delivery
patterns and incentives to ensure that every American with mental
illness has easy access to the most current treatments and best support
services.
The Substance Abuse and Mental Health Services Administration
(SAMHSA) was tasked by the Department to review the Commission's report
and to lead the development of an Action Agenda for that transformation
to create a more recovery-focused mental health services delivery
system. An executive team at SAMHSA-along with senior staff from six
Federal departments and the Social Security Administration-are working
collaboratively to conduct a thorough review and assessment of the
Report.
A hallmark of the Action Agenda is the unprecedented collaboration
and partnership across the Federal Government to work together and make
every effort to keep consumers and families at the center of care. I
look forward to working with you to continue this excellent effort.
Question 9. Perhaps the most significant finding in the report is
the recognition that the service system is hopelessly fragmented and
uncoordinated across multiple, disconnected programs, including those
related not only to mental health specifically, but also public health
and health care financing, housing, employment, rehabilitation,
criminal and juvenile justice, substance abuse, education, and child
welfare. In response, the Commission recommended that the relevant
departments--HHS, the Social Security Administration, Justice, Veterans
Affairs, Education, HUD--align their programs to improve access and
accountability for mental health services. [Commission Recommendation
2.3, page 37]. Will you work for White House leadership on mental
health and implementation of the Commission's recommendations?
Answer 9. As stated before, the Substance Abuse and Mental Health
Services Administration (SAMHSA) was tasked by the Department to review
the Commission's report and to lead the development of an Action Agenda
for that transformation to create a more recovery-focused mental health
services delivery system. An executive team at SAMHSA--along with
senior staff from six Federal departments and the Social Security
Administration--are working collaboratively to conduct a thorough
review and assessment of the Report. A hallmark of the Action Agenda is
the unprecedented collaboration and partnership across the Federal
Government to work together and make every effort to keep consumers and
families at the center of care. The result has been commitment for a
true Federal Action Agenda that is informed by the final report of the
New Freedom Commission and aligned with the President's priorities.
I understand that an announcement from the Substance Abuse and
Mental Health Services Administration on the availability of these
funds and how to apply will be issued in the near future. The purpose
of these grants is to help States overcome fragmentation by pulling
together State government offices and engaging multiple systems of care
together in a coordinated manner to focus on improving outcomes for
adults with serious mental illness and children with serious emotional
disturbance.
Obesity
Question 10. Overweight and obesity are major risk factors for
heart disease and stroke, two of the top three leading causes of death
in the United States. There have been many alarming reports about the
rate at which Americans are becoming obese. A Surgeon General's report
has called this problem an epidemic. Recent estimates indicate the
direct medical cost attributable to overweight and obesity is $78
billion dollars annually. And approximately half that amount, about $40
billion, is paid for with public dollars through the Medicare and
Medicaid programs. We must prevent Americans, and especially American
children, from becoming overweight. What do you think is the role of
the Secretary of Health and Human Services in getting the problem of
obesity and the related costs under control?
Answer 10. Seven of nine of the major causes of death in the United
States are caused by chronic diseases. The underlying causes of these
diseases are often behaviors that can be successfully modified thereby
reducing illness and death. Three factors--lack of physical activity,
poor nutrition, and tobacco use--are major contributors to the Nation's
leading killers; heart disease, cancer, stroke, chronic obstructive
pulmonary disease and diabetes. Too, the prevalence of overweight has
more than doubled in children and tripled in adolescents; indicators
suggest that diabetes too is increasing among children. This is
particularly troubling given obesity is a co-morbidity factor leading
to significantly increased risk of death due to cancer, heart disease
and diabetes.
In June 2002, President Bush launched the HealthierUS initiative to
utilize the combined expertise of the Federal Government to help
Americans live longer and healthier lives through simple changes in
their everyday lives. The four pillars of the HealthierUS initiative
are: 1) be physically active every day; 2) eat a nutritious diet; 3)
get preventive screenings; and 4) make healthy choices concerning
alcohol, tobacco, drugs and safety.
HHS is currently engaged in a number of key activities, two of
which are listed below. I look forward to examining what has been done
and what is underway, and working to continue this tremendous progress.
Current Activities:
Steps to a HealthierUS Initiative (Steps). Steps
specifically targets diabetes, asthma and obesity. In fiscal year 2003
Steps funded 23 communities. In fiscal year 2004 the program awarded
$44 million to help 16 additional communities develop action plans to
implement programs that promote disease prevention and health; the
total number of funded communities is 40. Steps also received $1.5
million to fund one national program, YMCA's Activate America. Fiscal
year 2005 appropriations budget for Steps is approximately $47 million.
National Coverage Decision--Earlier this year, HHS
announced a new Medicare coverage policy that would permit Medicare to
cover anti-obesity interventions if scientific and medical evidence
demonstrate their effectiveness in improving Medicare beneficiaries'
health outcomes. The new policy removes language in the Medicare
Coverage Issues Manual stating that obesity is not an illness, allowing
Medicare to determine if specific obesity-related treatments should be
covered by Medicare.
Nutrition and Dietary Concerns
Sodium
Question 11. Research over the last half-century has demonstrated
that high-sodium diets (due mostly to the salt in packaged and
restaurant foods) are a major cause of high blood pressure. For the
past quarter-century, Dietary Guidelines for Americans, which is
published by USDA and HHS, has advised consumers to consume less
sodium. Notwithstanding that advice and similar advice from the
National Institutes of Health and the National Academy of Sciences,
Americans' consumption of sodium has not decreased, but increased.
Though mandatory nutrition labeling, begun in 1994, on packaged foods
has been useful to millions of people, it has had little apparent
effect in reducing Americans' average sodium intake, according to HHS's
National Health and Nutrition Examination Surveys (NHANES) in 1988-94
and 1999-2000. In 1994, the National High Blood Pressure Education
Program (part of the National Heart, Lung, and Blood Institute) said
that ``it is critical that the food industry reduce (or continue to
reduce, in some cases) the content of sodium in generally available
processed foods.'' The NHBPEP has said that reducing sodium levels
could save tens of thousands of lives per year. However, judging from
current trends, the goal in HHS's Healthy People 2010 (published in
2000) of increasing the percentage of people consuming 2,400 mg or less
of sodium per day from 21 percent to 65 percent will never be met. What
will you do to reduce the sodium content of packaged and restaurant
foods and reduce the incidence of high blood pressure?
Answer 11. I believe that HHS has done a tremendous job in focusing
public attention on the issues relating to wellness, prevention and
obesity, and that these efforts are bearing fruit. As part of these
efforts, HHS has been able to work collaboratively with outside
stakeholders, including the food and restaurant industry, to make
important progress. An example of this is the improved nutritional
labeling information that is available through many restaurants. I hope
to continue this collaborative approach and work with all interested
parties to improve the health of the Nation.
Trans Fat in Partially Hydrogenated Vegetable Oils
Question 12. Trans fat in partially hydrogenated vegetable oils is
a major public health problem because it promotes heart disease. In
July 2002 the Institute of Medicine (``IOM'') of the National Academy
of Sciences concluded that the consumption of Trans fat is at least as
unhealthful as the consumption of saturated fat and that consumption of
trans fat in any amount increases the risk of heart disease. In
December 2003 the IOM concluded that it is feasible to exclude from the
diet trans fat from partially hydrogenated vegetable oil.
In April 2004 the Nutrition Subcommittee of the Food and Drug
Administration (``FDA'') Food Advisory Committee concluded that trans
fat is more conducive to coronary heart disease than is saturated fat.
In August 2004 the Dietary Guidelines Advisory Committee reported to
Secretary Thompson and Secretary Veneman that consumption of trans fat
from both partially hydrogenated oils and meat and dairy products
should be limited to one percent of total calories. Do you believe that
it would promote the public health if partially hydrogenated vegetable
oils were eliminated from both packaged and restaurant foods? If so,
what steps will you take as Secretary to bring this about?
Answer 12. Saturated fat, trans fat and cholesterol intake are
associated with risk of cardiovascular disease. As indicated in the
Dietary Guidelines for Americans, controlling the intake of all three
of these lipids is important for managing health risk. In response to
FDA's rule that trans fat must be on food labels by January 2006, the
food industry has taken significant steps to lower the trans fat
content of food products. These steps include the development of
products that can replace partially hydrogenated oils as well as
improvements in the hydrogenation process to prevent formation of trans
fatty acids. During this transition in product formulation, it is
important that the reduction of trans fat from certain oils not be
achieved simply by switching to fats that are high in saturated fatty
acids but by development of healthier alternatives to these fats. FDA
is currently reviewing proposals for making claims about the trans
fatty acid content of foods, and once finalized such claims could
provide additional incentives to the food industry to lower the trans
fat content of certain foods. If confirmed, I will work to advance
these initiatives to address health concerns associated with the use of
partially hydrogenated vegetable oils in packaged and restaurant foods.
Food Safety
Question 13. The safety and quality of the U.S. food supply is
governed by a fragmented and overlapping system. That system is based
on more than 30 laws, over 50 inter-agency agreements, and administered
by 12 agencies. These agencies work to ensure basic food safety,
address human and animal nutrition, deal with naturally-occurring food
borne pathogens, protect the environment, monitor the incidence of
disease, and develop effective research programs. President Bush,
former Secretary of Health and Human Services Tommy Thompson and
Homeland Security Director Tom Ridge all have publicly discussed
combining Federal food-safety responsibilities into a single agency. Do
you support consolidating food safety authority by modernizing food
safety laws and creating a single agency responsible for protecting the
American food supply?
Answer 13. As you know, in 2002, President Bush signed into law the
Public Health Security and Bioterrorism Preparedness and Response Act
(Bioterrorism Act) which gave FDA new authorities to ensure the safety
of the food supply. I believe the current food safety system is
working. The American food supply continues to be among the safest in
the world. Federal agencies with food safety authorities are working
together effectively. As Secretary, I will continue to support this
enhanced cooperation among all of our food safety partners that can
increase the effectiveness of our food safety system.
Question 14. How would you improve FDA's oversight of imported
food?
Answer 14. Through the authorities under the Bioterrorism Act, FDA
was recently equipped with significantly enhanced tools to ensure the
safety of the food supply. If confirmed as Secretary, I plan to work to
ensure that FDA is effectively using the ample authorities recently
enacted by Congress relating to imported foods. These authorities
include requirements that prior notice of imported food shipments be
submitted to FDA. FDA is currently receiving about 30,000 advance
notices per day. FDA uses this information to make risk-based decisions
about the admissibility of imported food shipments before the food may
proceed into commerce. To implement the Prior Notice requirement, FDA
established and staffed the Prior Notice Center, a first-of-its-kind
activity which operates on an around-the-clock basis to accommodate the
global economy.
The Bioterrorism Act also requires that the owner, operator, or
agent in charge of a domestic or foreign facility to register with FDA.
Now, for the first time, FDA has a roster of foreign and domestic food
facilities, allowing timely notification and response in the event of a
food safety threat.
The Act also requires that records be created and maintained to
enable FDA to determine the immediate previous sources and the
immediate subsequent recipients of food. In the event of credible
threats of serious adverse health consequences or death to humans or
animals, this requirement will enable FDA to identify the source of the
contamination and to remove adulterated food from commerce, thus
preventing foodborne illnesses and deaths.
The Bioterrorism Act also contains authority to order the
administrative detention of food if there is credible evidence or
information indicating that an article of food presents a threat of
serious adverse health consequences or death to humans or animals.
With these new tools, FDA can continue to improve its oversight of
imported food.
In addition to those protections discussed above, FDA and U.S.
Customs & Border Protection (CBP) signed a Memorandum of Understanding
(MOU) in December 2003 that allows ORA to commission thousands of CBP
Officers in ports and other remote locations to conduct, on FDA's
behalf, investigations and examinations of imported foods. This
agreement provides a contingency plan to assure adequate regulatory
coverage at the 300 ports through which imported food may be offered
for entry into domestic commerce. Moreover, to ensure prompt access for
specified analytical testing of imported foods at U.S. ports of entry,
FDA and the U.S. Army's Edgewood Chemical Biological Forensic
Analytical Center designed, constructed, and equipped two mobile
laboratories. FDA is now deploying these labs and will soon start
operation.
In tandem with those protections discussed above, FDA continues to
improve its food import program. This continuing improvement effort
focuses on evaluation of risk associated with imported food shipments
based on several factors: the source(s) of a finished product,
intelligence information gathered from both foreign and domestic
sources, adherence to good manufacturing practice requirements, the
compliance history of all of those entities involved in the
distribution chain, and shipping conditions. This risk-based approach
will enhance FDA's effectiveness and efficiency by enabling FDA to
target shipments for further investigation and/or testing and will
complement FDA's traditional examination activities at the border.
Question 15. Do you think that FDA should have mandatory recall
authority to protect consumers from contaminated food that is
distributed around the country?
Answer 15. It is my understanding that FDA has authority under the
Federal Food, Drug, and Cosmetic Act to remove a violative product from
the market by using its seizure authority. In addition, in 2002,
President Bush signed into law the Public Health Security and
Bioterrorism Preparedness and Response Act (Bioterrorism Act) which
gave new powers to FDA to administratively detain foods for which there
is credible evidence or information that the food presents a threat of
serious adverse health consequences or death to humans or animals. This
domestic authority is coupled with the authority to detain imported
foods at ports of entry for a period of time sufficient to ensure their
compliance with FDA standards and safety. FDA has been working hard to
implement these and other provisions of the Bioterrorism Act.
Effects of Nuclear Weapons Testing
Question 16. The Radiation Exposure Compensation Act makes
available modest compensation to some downwinders in some high-fallout
counties in Utah, Nevada, and Arizona. Since passage of RECA, a 1997
National Cancer Institute report found that US atmospheric nuclear
testing exposed nearly everyone who lived in the US in the 1950s and
early 1960s to radioactive fallout. People who lived in many counties
in Idaho, Montana, North Dakota, South Dakota, Kansas, Nebraska, Iowa,
Missouri, and Arkansas were severely exposed. Will you support just
redress for additional people who have been made sick from fallout by
expanding RECA coverage?
Answer 16. Thank you for your continued support for the RECA
programs and your focus on using the best science possible in the
administration of these programs. As the former Governor of Utah, this
is an issue with which I am very familiar. As you know, the Department
of Justice administers the Radiation Exposure Compensation Program,
which provides compassionate compensation to individuals, or their
beneficiaries, who contracted certain cancers or other serious diseases
as a result of their exposure to radiation from U.S. nuclear testing
and uranium mining. Since 1990, when the RECA legislation was enacted,
coverage has been expanded based on available scientific information.
The Department of Energy also administers a program that provides
benefits to Department of Energy employees and contractors who have
been approved for an award under RECA.
Through HHS, individuals in Utah, Colorado, New Mexico, and Arizona
have access to cancer screening, early detection, medical referrals,
education, and assistance with compensation claim documentation. This
program, the Radiation Exposure Screening and Education Program,
provides grants to six health care organizations in these States. HHS
is also overseeing a research project by the National Academies'
National Research Council on whether other classes of individuals or
additional geographic areas should be covered under RECA, and on how
services can be improved based on the most recent scientific
information. The report is expected to be delivered to Congress this
summer.
Question 17. Following release of the 1997 NCI study, the Senate
Appropriations Committee asked the Department of Health and Human
Services (HHS) to conduct an initial assessment of the feasibility and
public health implications of a study concerning the health
consequences to the American population of radioactive fallout from
nuclear weapons testing. In 2002, HHS transmitted to the Senate
Appropriations Committee a progress report and an extensive, two-volume
draft Feasibility Study. The draft was also sent to the National
Academy of Sciences Committee on Assessment of CDC Radiation Studies,
which released a report in February 2003. Despite repeated requests HHS
has not released the Feasibility Study. Will you work to expedite
release of the final Feasibility Study, which we understand has been
complete for some time?
Answer 17. Yes, if I am confirmed, I will ensure that the release
of the final report will be expedited. HHS transmitted to the Senate
Appropriations Committee a progress report and draft report in 2002.
The draft report was also posted on the CDC website for public comment
and was sent to the National Academy of Sciences for review. The NAS
Committee issued a report in February 2003. CDC and NCI have been
working together to carefully review and respond to all comments from
NAS and the public. Because of the length and complexity of the report,
making and reviewing the changes have been quite time consuming.
However, the basic technical content and findings have not changed
since the draft report was published. The final report will present
little information that was not already available to the public in the
draft report.
Question 18. One of the key obligations growing out of the 1997 NCI
study was to inform people exposed to radioactive fallout and their
health care providers of the potential health impacts. But HHS has done
very little in this regard. What will you do as Secretary of HHS to
insure that people exposed to high levels of radiation without their
knowledge first are informed about their potential exposures and health
consequences and second that they receive adequate health care?
Answer 18. As the former Governor of Utah, this is an issue with
which I am very familiar. As you know, HHS administers a community
grant screening and education program, the Radiation Exposure Screening
and Education Program, which provides access to cancer screening,
education, and medical referrals. The program, administered by the
Health Resources and Services Administration (HRSA), provides grants to
six health care organizations in Utah, Colorado, New Mexico, and
Arizona. These organizations screen for the early warning signs of
cancer, provide medical referrals, educate individuals on prevention
and treatment of radiogenic diseases, and assist with compensation
claim documentation. HRSA also oversees a research project by the
National Academies' National Research Council on whether other classes
of individuals or additional geographic areas should be covered under
RECA, and on how services can be improved based on the most recent
scientific information. The report is expected to be delivered to
Congress this summer.
In addition to this grant program, HHS has developed extensive
information for individuals about assessing their risk for thyroid
disease--which is the most important harmful radioactive material and
can lead to thyroid cancer--and what to do if they are concerned about
this possibility. If I am confirmed, I will stand ready to work with
you to ensure that these and other HHS activities continue to educate
and treat people exposed to high levels of radiation.
The Safety of Dietary Supplements
Question 19. Do you believe that the current law regulating the
safety of herbal dietary supplements is adequate? Do you think that it
would be useful to commission the National Academy of Sciences to
review the safety and efficacy of dietary supplements?
Answer 19. In November 2004, FDA published a regulatory strategy
that lays out the Agency's direction in implementing all the provisions
of the Dietary Supplements Health and Education Act (DSHEA). The
strategy is designed to give consumers a higher level of assurance
about the safety of dietary supplement products and the reliability of
their labeling, as well as to improve the transparency, predictability,
and consistency of the Agency's scientific evaluations and regulatory
actions to protect consumers against unsafe dietary supplements and
dietary supplements making unauthorized, false, or misleading claims.
The Agency will continue its ongoing efforts of monitoring and
evaluating product safety, ingredient safety, and product labeling, as
well as ensuring product quality. Recently, the Agency took action on
ephedrine alkaloid-containing dietary supplements because they present
an unreasonable risk of illness or injury. The courts are now reviewing
this decision.
In 2001, FDA funded an Institute of Medicine/National Academy of
Sciences (IOM/NAS) study on the safety evaluation of dietary
supplements. FDA considered this report, along with other information,
in developing the initiative for full implementation of DSHEA. The NIH
has recently funded an IOM/NAS study on complementary and alternative
medicine. In light of this recent study, we do not believe that another
study would provide additional benefits to the Agency.
Underage Drinking Legislation (STOP Act)
Question 20. As Secretary, what would you do to elevate underage
drinking prevention as a national public health priority? Would you
include an underage drinking prevention initiative in your fiscal year
2006 or 2007 budget request?
Answer 20. Under Secretary Thompson, SAMHSA convened the
Interagency Coordinating Committee on the Prevention of Underage
Drinking (ICCPUD), that is made up of representatives from the Office
of the Surgeon General, the Centers for Disease Control and Prevention,
the Administration for Children and Families, and the Office of the
Assistant Secretary for Planning and Evaluation, the National Institute
on Alcohol Abuse and Alcoholism, the Department of Justice/Office of
Juvenile Justice and Delinquency Prevention, the Department of
Education/Office of Safe and Drug Free Schools, the Department of
Transportation/National Highway Traffic Safety Administration, the
Office of National Drug Control Policy, the Department of the Treasury,
the Department of Defense, and, ex officio, the Federal Trade
Commission.
The Department, in consultation with the ICCPUD, is to develop a
comprehensive Federal plan for addressing the issue of underage
drinking. An interim plan has been submitted to Congress for their
consideration. The interim plan includes the following three goals:
Goal 1: Strengthen a national commitment to address the problem of
underage drinking.
Goal 2: Prevent underage drinking and its negative consequences.
Goal 3: Use research, evaluation, and surveillance to improve the
effectiveness of programs and policy designed to reduce underage
drinking.
These are important goals, and I look forward to working with you
to help achieve them.
Fetal Alcohol Syndrome Prevention
Question 21. Would you support the re-issuance of a Surgeon
General's advisory on the dangers of drinking during pregnancy?
Answer 21. On 4 December 2004, the Surgeon General released an
updated advisory on the dangers of drinking during pregnancy. This
advisory updates the one issued in 1981 to reflect scientific evidence
amassed since that time on trends in alcohol use among pregnant women
and the consequences of prenatal alcohol exposure.
______
Response to Questions of Senator Clinton
Kinship Care/Child Welfare
Question 1. As you well from your experience as Governor, there has
been a significant rise in the number of children living in kinship
care arrangements--living with their grandparents, aunts, uncles,
siblings or other relatives because their parents are unable to care
for them. You oversaw the establishment of Utah's subsidized
guardianship program to support these families. Today that program is
serving about 117 children. We think this is a terrific model--one that
should be supported through the Federal Government's foster care
system. But as you know, States may not use their Title IV-E funds to
assist kinship care families, and HHS has not granted a State waiver
for this purpose since President Bush took office. Senator Clinton has
introduced legislation with Senator Snowe to expand the uses of IV-E to
include subsidized guardianship arrangements.
Can we count on your support of this proposal as we reauthorize
Title IV-E?
Answer 1. Thank you very much for your comments on Utah's
guardianship program. I am extremely proud of the work we did in Utah
to strengthen our foster care program. I understand that HHS recently
approved a waiver for one State to fund kinship care and that there are
others in process. However, I am a strong proponent of maximum State
flexibility and believe the President's Child Welfare Program Option
provides a much better approach for supporting State innovation than
the existing waiver process.
Under the President's proposal, States would be offered the
opportunity to receive their foster care funding as a flexible grant to
develop a seamless child welfare system that supports a continuum of
services to families in crisis and children at risk. States that choose
the option would be able to use the funds for foster care payments,
prevention activities, permanency efforts (including guardianship) and
administrative and other service related child welfare activities.
I strongly urge you to support the President's proposal and look
forward to working with you on this key legislative initiative to
support innovation and strengthen child welfare programs and the
critical services they provide to this vulnerable population.
Family Planning
Question 2. As you know, Title X is the cornerstone of our Nation's
family planning program. For millions of low-income women it is the
only access to healthcare they have. It is also cost effective--saving
three dollars in Medicaid costs for every dollar expended. Yet, the
Title X appropriation has lost significant value since the early 80s.
If the program had only kept pace with inflation--experience no
increase at all--since 1981, the funding level would be double what it
is today. Can we count on you to strongly support Title X by increasing
the budget proposal for Title X funds?
Answer 2. Title X, as you pointed out, has a long history of
providing family planning services and there were considerably fewer
family planning options for low-income women when the program was
created 35 years ago than there are today. For example, in 1970 very
few States had dedicated funds for family planning. Since then,
however, virtually all States have committed resources to help women
plan for healthy families. In addition, the growth of more avenues of
support in the Federal and private sector have made it possible for
many, many more low-income women in the United States to have access to
free or affordable family planning services.
Title X funding itself has increased from $162 million in 1981 to
its current level of more than $280 million. In addition, the Maternal
and Child Health Block Grant programs and Community Health Centers are
among the new resources though which low-income women can and do
receive subsidized care. By far the largest expenditures for family
planning services, however, are made under the Medicaid program and, in
particular, the Medicaid waivers granted to States to provide family
planning assistance. In 2004, over $810 million in Federal funds were
expended for fee-for-service family planning services under Medicaid.
With the expansion of Medicaid waivers, more women than ever are able
to have access to family planning services. We need to continue to
access program effectiveness and determine how we can best serve our
target population with the resources at our disposal.
As the Nation's healthcare funding continues to change, I am
committed to ensuring that low-income women and men continue to have
access to basic family planning services and care, including those
services necessary to prepare for planned, healthy pregnancies. I am
sensitive to the need for both fiscal discipline and the assurance that
we are meeting our current program funding obligations. As Secretary, I
will work very hard to ensure that women are able to receive adequate
access to necessary services.
Plan B
Question 3. We are am deeply concerned that the FDA's process for
determining over the counter status became politicized during the
``Plan B'' application process. The FDA's own advisory committee voted
23-4 in December of 2003 to approve Plan B for over-the-counter status.
The panel also unanimously agreed that Plan B is safe for use in the
non-prescription setting and unanimously rejected the claim (voting 0-
28) that use of Plan B leads to substitution of emergency contraception
for the regular use of other methods of contraception. Over 70
organizations, including the American Academy of Pediatrics and the
American Associations of American College of Obstetricians and
Gynecologists, have recommended that it be available over the counter.
What principles do you believe should guide the FDA when it makes
decisions about what drugs may be available over the counter? Under
what circumstances do you believe it is appropriate for the FDA to
override such strong scientific evidence in making such decisions?
Answer 3. As you know, the FDA previously denied an application to
change this drug to over-the-counter status, because the supplemental
application did not meet the criteria for approval in that it did not
demonstrate that Plan B could be used safely by young adolescent women
for emergency contraception without the professional supervision of a
licensed practitioner.
I understand that the sponsor has subsequently submitted a new
application, and that the application is being reviewed by the
scientists at FDA--and that action is due on this application soon.
Head Start
Question 4. I understand HHS is moving forward with its plan to
test every four-year-old in Head Start via the National Reporting
System. As you know, many childhood development experts have raised
concerns about the NRS. On February 28, 2003, a number of experts sent
a letter to senators expressing their concerns about the implementation
of the NRS. In an October 28 joint press release, Dr. John Meier,
Ph.D., Dr. Lonnie Sherrod, Ph.D., and Dr. Susanne A. Denham, Ph.D.,
respected professors and researchers in the field of early childhood,
suggested that the proposed outcomes are too rigid and that the
National Academy of Sciences (NAS) should have the ``flexibility to
design both the test (or tests) and the outcome standards.'' They also
believe it be detrimental to tie any type of program funding to the
outcomes of this test. Can we have your assurance that the NRS will
never be used to make decisions about which programs receive funding?
What plan does HHS have to ensure that children with special needs and
those from Limited English Proficient households will be assessed using
measures that are appropriate? Have HHS made progress in identifying
and training LEP individuals to administer the NRS to children from LEP
households?
Answer 4. I share the President's commitment to accountability and
to measuring the outcomes of program efforts, including the Head Start
program. We must do a better job of determining how well Head Start
children across the country are being prepared for academic success
once they enter school and the National Reporting System (NRS) is
critical to this effort.
The results will be useful in planning new approaches for
strengthening Head Start program quality and effectiveness. The
information also can be used to identify common national, regional and
local needs for training and technical assistance as well as help in
identifying programs that are unusually effective in promoting
children's progress. However, it is my understanding that there are a
number of ways in which Head Start programs are monitored and
evaluated, and I can assure you funding decisions for Head Start
programs will not be based solely on the information in the NRS.
I understand your concerns about the needs for sensitivity in
assessing children with special needs and those from Limited English
Proficient households. It is my understanding and expectation that
appropriate and required adaptations will be made to allow special
needs children to fully and fairly participate in the NRS assessment.
Currently, the child assessment is available in both English and
Spanish and only trained and certified assessors, including those
fluent in Spanish, will be used. Given the wide and ever-increasing
diversity of Head Start children and families, I look forward to
reviewing the recommendations from the newly formed advisory Committee
on Head Start Accountability and Educational Performance Measures on
this specific issue as well as other Head Start questions of
accountability.
Medicaid
Question 5. New York State has the second highest Medicaid
population in the Nation, and the Medicaid program ensures that
millions of New Yorkers are able to access crucial health care
services. I would like to stress the importance of preserving such
benefits, and I was pleased to see that in your opening statement, you
recognized the importance of providing access to care for our Nation's
poor, elderly and disabled populations. I have specific questions about
your views on some of the possible proposals for Medicaid reform.
In 1997, you were one of the architects of the National Governors
Association's Medicaid reform package. In that package, you opposed
placing Federal spending caps upon the Medicaid program. However, the
Administration has stated that it favors such a proposal. What is your
current position on Federal Medicaid spending caps, and how do you
propose to offer States fiscal relief from rapidly increasing Medicaid
costs?
Answer 5. The Administration has not proposed to block grant the
program. It is committed to maintaining the entitlement of mandatory
populations to mandatory services. At the same time, I believe that
States can be given more flexibility to extend health insurance
coverage to more low-income individuals and families.
Question 6. As part of your Medicaid reform package in Utah, you
cut benefits for recipients in order to expand the program to cover
low-income uninsured individuals. Yet the expanded program failed to
provide comprehensive coverage and did so through a model in which
Federal and State dollars were used to subsidize private insurance
companies. How will you increase the flexibility given to States within
Medicaid while ensuring that there remains an adequate benefit package
that is so desperately needed by so many Medicaid recipients?
Answer 6. First and foremost, I believe strongly that waivers
provide States with the flexibility to implement innovative ways to
extend health coverage to more people. This is a goal we should all
support. The waiver that I implemented in Utah did not make any changes
to the benefit for mandatory populations. Instead, the waiver expanded
preventive and primary care coverage to an additional 25,000 uninsured
adults. To do so, a $50 enrollment fee was instituted, but with
exemptions for vulnerable optional populations (including the elderly,
blind, disabled, children and pregnant women).
States are not required by the Medicaid law to cover optional
populations, yet hundreds of thousands of people in this country--who
would otherwise be uninsured--now have access to healthcare because
States have been granted modest flexibility in designing and
implementing Medicaid expansions. I simply disagree with the suggestion
that the better policy would be to leave all of these people without
any health care.
Information Technology and Health
Question 7. As governor of Utah, you were a pioneer in efforts to
increase efficiency through the use of interoperable information
technology systems within the State government. During your testimony
before the HELP Committee, you reaffirmed your interest in using
information technology to improve the quality of care and reduce
overall health care costs. However, the Office of Healthcare
Information Technology within HHS did not receive any funding in the
recent omnibus appropriations bill.
As Secretary, how will you support the efforts of the National
Coordinator for Health Information Technology and work with Congress to
provide increased access to and use of information technology in
healthcare? In addition, how do you plan to promote and implement
health care information technology as a tool for improving overall
healthcare quality?
Answer 7. The President believes that better health information
technology is essential to his vision of a health care system that puts
the needs and the values of the patient first and gives patients
information they need to make clinical and economic decisions. I
believe that the Federal Government can play a critical role in
encouraging and facilitating the adoption and use of health information
technology, and I am keenly interested in this issue. Innovations in
electronic health records and the secure exchange of medical
information can help transform health care in America--improving health
care quality, preventing medical errors, reducing health care costs,
improving administrative efficiencies, reducing paperwork, and
increasing access to affordable health care. The goal is to encourage
widespread private adoption of health it without heavy-handed
regulation or upheaval in the health care sector. HHS is currently
undertaking efforts in four areas identified under its strategic
framework--informing clinical practice, interconnecting clinicians,
personalizing care, and improving population health--and we should and
will continue these efforts. I look forward to the opportunities that
lie ahead in the area of health information technology, and will work
with Congress in that process.
HIV/AIDS and Ryan White Funding
Question 8. There are over 900,000 people in the United States who
are infected with HIV/AIDS. New York State has borne the brunt of this
epidemic, and has had both the highest cumulative number of total AIDS
cases and the highest number of new AIDS cases in 2003. I cannot stress
the importance of Ryan White funding to people living with HIV/AIDS in
New York, many of whom are poor, disabled, uninsured, or underinsured.
The dedicated funding stream provided by this bipartisan-supported law
allows people living with HIV/AIDS to access services that are not
covered under the Medicaid or Medicare programs. While the President
has already announced his support for reauthorization, I would like to
gain a greater understanding of your commitment to the Ryan White
program, and the priority that this reauthorization will have within
your agency. Specifically:
How will you ensure that the epidemiological profile of the
epidemic, which shows that New York City is one of the epicenters of
this epidemic in the United States, is adequately reflected in funding?
Answer 8. Thank you for your support for the Ryan White CARE Act. I
understand your concern for the people of New York who are living with
HIV and AIDS. The Administration continues to finalize its assessment
of the successes and drawbacks of the current Ryan White CARE Act
(RWCA) statute. Through the reauthorization process, there are
opportunities to strengthen the various RWCA programs and to make them
more effective. Treatment for people living with HIV/AIDS has changed
significantly since the last RWCA reauthorization. If I am confirmed as
Secretary, I will work hard to ensure a successful reauthorization. As
I am sure you are aware, the President laid out the principles that
will be used in guiding this process: (1) focus Federal resources on
life-extending care and a core set of clinical services, (2) provide
greater flexibility to better target resources to address areas of
greatest need, (3) encourage participation of any provider, including
faith based and community organizations, that show results, recognizing
the need for State and local planning, and ensuring accountability by
measuring progress.
With regard to ensuring that funding adequately reflects the
profile of the epidemic, the President's second reauthorization
principle is to ensure that the Secretary has greater flexibility to
target resources to areas of greatest need. This will be an important
aspect of any reauthorization discussions. As you know, RWCA grants
that are distributed by formula are currently based on estimated living
AIDS cases. Under the formulas for Title II grants to States and Title
I grants to Eligible Metropolitan Areas, New York State and New York
City have each received over $1 billion between 1991 and 2004. The
Institute of Medicine (IOM) issued a report in 2003 that examined
whether States' HIV surveillance systems could provide adequate and
reliable information on the number and demographic characteristics of
cases of HIV infection on which to base RWCA formula grants. The study
considered issues of State capability, comparability of data across
jurisdictions, whether HIV data would be a more accurate measure of
disease burden, and whether material variation and equitable
allocations would result. While the IOM supported Congressional intent
to incorporate data into the allocation formulas that reflect the
evolving needs of the epidemic, their overall finding was ``that
States' HIV reporting systems are neither ready nor adequate for
purposes of the Ryan White CARE Act allocation.'' Therefore, Secretary
Thompson concluded that HIV data should not be used for purposes of
making formula grants under Titles I and II of the RWCA, and that
estimated living AIDS cases should continue to be utilized until such
time as HIV data is judged to be useful. HHS will continue to work with
States to support an HIV surveillance system that ensures the
collection of such data.
Question 9. How will you ensure that Ryan White Funding is able to
provide the appropriate mix of support and treatment services for the
many conditions faced by people with HIV, including everything from
homelessness to increased rates of Hepatitis C infection?
Answer 9. When the RWCA was originally enacted, people living with
AIDS had little hope. Treatment focused on support services for people
who were severely disabled and dying. Medical advances and new
medications have enabled people to live longer, healthier lives and
treatment has shifted toward helping people live with a chronic
disease. At the same time, those entering care are more likely to be
poor, minority, and have other complex issues, such as substance abuse
and mental health issues. As we consider the successes and drawbacks of
the current RWCA statute in the context of reauthorization, and discuss
ways to make the program more effective, we will identify strategies
that enable HHS to meet these changing needs and provide more
flexibility to target resources to the areas with the greatest need.
EPA and Industry
Question 10. While you were serving as EPA Administrator, the
agency was forced to suspend implementation of its Children's
Environmental Exposure Research Study (CHEERS), a program partially
funded by the American Chemistry Council, in response to concerns over
potential harm to participants. Opponents of the study are concerned
that industry involvement would influence the methodology and outcomes
of the study, and EPA has taken the step of re-examining the study's
protocol in response to these charges. While I appreciate the
responsiveness of the agency to these concerns, I am deeply concerned
about the safety of research participants, as well as the children who
would eventually be affected by the outcome of this study.
At HHS, similar concerns have been raised about the influence of
private companies, particularly the pharmaceutical industry, upon the
activities of HHS agencies. The recent withdrawal of Vioxx and the
controversy surrounding side effects of pediatric antidepressant use
have called attention to the industry's influence on the FDA drug
approval process and the inability of the agency to guarantee the
safety of these drugs after they are marketed to the public.
What actions will you take as Secretary to ensure that the FDA
operations are not influenced by drug company financing, and how will
you guarantee the safety of drugs after they become available on the
market?
Answer 10. If confirmed, I will work to ensure that FDA performs
its important statutory responsibility to monitor the safety of
approved drugs. The enhanced post-marketing surveillance provisions in
the Prescription Drug User Fee Act provide new tools and opportunities
to accomplish this goal.
EPA and the Safety of Nuclear Workers
Question 11. The Energy Employees Occupational Illness Compensation
Act (EEOICPA) was passed by Congress in 2000. This law is intended to
compensate former nuclear weapons workers whose illnesses were caused
by exposure to radiation during weapons production-related activities.
This program is extremely important to my constituents, as a
considerable amount of this work was performed in New York during the
1940s and 1950s. Under EEOICPA, the Secretary of HHS has significant
direct responsibilities, as does the National Institute for
Occupational Safety and Health (NIOSH). One of the direct
responsibilities of the Secretary under EEOICPA is to act on
recommendations of the Advisory Board on Radiation and Worker Health.
And the next several months, the Advisory Board will be forwarding to
the Secretary of HHS a set of recommendations about the Bethlehem Steel
site in Lackawanna, NY. Hundreds of claimants who worked at the
Bethlehem Steel site have been waiting for years to have their claims
considered fairly, which will depend in part on your reaction to
Advisory Board's recommendations.
If confirmed, will you act promptly on these recommendations after
you receive them? In addition, if confirmed, will you work with me to
address concerns about implementation of the program by NIOSH as they
arise?
Answer 11. NIOSH responsibilities under Energy Employees
Occupational Illness Compensation Program Act of 2000 had to be
fulfilled before NIOSH could begin processing claims. NIOSH had to hire
staff, establish procedures and promulgate three rules to create the
process and systems to run the program; a backlog was created because
the program was receiving claims before processes were in place.
As of January 20, 2005, NIOSH has completed more than 50 percent of
the claims from New York and nearly 40 percent of all claims received
from the Department of Labor. In addition, the promulgation of the
Special Exposure Cohort rule in May 2004 will speed determination of
claims for which it is not possible to perform a dose reconstruction
with sufficient accuracy. NIOSH will continue to strive to improve its
performance.
World Trade Center Expert Technical Review Panel
Question 12. While you served as the Administrator of the
Environmental Protection Agency, we worked together to form and launch
the World Trade Center Expert Technical Review Panel. I appreciate the
attention that you gave to this important issue during your time at
EPA. As you know, the Department of Health and Human Services is
represented on the panel. As its work continues in 2005, the panel will
shift its focus to examining the health consequences of exposure to
contamination released from the collapse of the World Trade Center. I
believe that HHS is uniquely suited among the Federal agencies
represented on the panel to address these issues.
Will you work with me to strengthen the role of HHS on the panel to
help ensure that the panel addresses these issues in a timely and
comprehensive manner?
Answer 12. As Secretary of HHS I would continue the commitment I
made as Administrator of EPA to the important work of the World Trade
Center Expert Technical Review Panel. As you know, the Centers for
Disease Control and Prevention, the Agency for Toxic Substances and
Disease Registry, and the National Institutes of Health are working in
collaboration with other public and private entities, such as the New
York City Department of Health and Mental Hygiene, and academic and
health care institutions, many of which also are represented on the
Panel, on projects relating to the health consequences of exposure to
contamination released in the World Trade Center disaster.
Food Safety
Question 13. Listeria monocytogenes is the most virulent of
foodborne pathogens, killing 20 percent of those infected, with
pregnant women and their unborn children being particularly
susceptible. While the U.S. Department of Agriculture (USDA) and HHS
had publicly committed in 2000 to reducing the rate of listeria
poisoning by half by 2005, the deadline for this halving has since been
pushed back to 2010. Will you reinstate the goal of halving the
Listeria food poisoning rate by the end of 2005, rather than 2010?
Answer 13. The goal has always been stated in the Healthy People
2010 document as a 50 percent reduction in illness attributed to
Listeria monocytogenes by 2010. In FDA's Listeria monocytogenes Action
Plan document, FDA stated its own goal would be to achieve this
reduction by 2005. The baseline for calculating the reduction is 0.47
illnesses per 100,000 population with the goal of 0.25 illnesses/
100,000. My understanding is that we are on target for reaching the 50
percent reduction with a current incidence rate of 0.26 illnesses per
100,000 population.
Question 14. The FDA is given the mission of ensuring the safety of
our food supply, and I was pleased of hearing of your commitment to
maintaining the FDA brand. However, I am concerned about the manner in
which the FDA is handling the threat of bovine spongiform encephaly
(BSE), several cases of which have emerged recently in Canada. Both
Secretary Thompson and former FDA Administrator Mark McClellan have
affirmed the importance of FDA action in regards to the contents of
bovine feed. However, the USDA, which is not charged with ensuring the
safety of our food, has largely taken the lead on this issue. What
specific FDA action will you take to remove the threat of BSE-
contaminated cows from our food supply, and how will you work with USDA
to strengthen the regulations in this area?
Answer 14. On July 14, 2004, FDA published an Interim Final Rule,
effective immediately, banning use of specified risk materials (SRMs)
and other prohibited cattle materials in all FDA-regulated foods and
cosmetics. Prohibited cattle materials include SRMs from cattle 30
months of age and older, small intestine of all cattle, materials from
nonambulatory disabled cattle, material from cattle not inspected and
passed for human consumption, and mechanically separated beef--these
are the cattle materials at highest risk of containing prions. The FDA
foods regulation parallels the USDA Interim Final Rule, also effective
immediately, for meats and meat products. The agencies cooperated in
the development of these documents and continue to cooperate to
maintain a harmonized U.S. food safety policy for BSE.
Both the FDA regulation covering foods and cosmetics and the USDA
regulation covering meat and meat products augment the preventive
measures already in place to reduce or eliminate the threat of BSE in
the U.S. and in the U.S. food supply. These measures include FDA's 1997
regulation that prohibits, with some exceptions, the use of protein
derived from mammalian tissues in feed for cattle and other ruminant
animals--the basis of the agency's efforts to prevent the spread of BSE
in U.S. cattle. They also include the import prohibitions imposed by
USDA/APHIS.
Science and Ideology
Question 15. The National Academy of Sciences recently issued a
report on how the Administration screens nominees for advisory panels
in areas of science and technology. Specifically, the report
recommended the following:
``When a Federal advisory committee requires scientific or
technical proficiency, persons nominated to provide that expertise
should be selected on the basis of their scientific and technical
knowledge and credentials and their professional and personal
integrity. It is inappropriate to ask them to provide nonrelevant
information, such as voting record, political-party affiliation, or
position on particular policies.''
How will you ensure that scientific expertise, rather than
political views, is the crucial factor in determining whether a
candidate is qualified for an advisory panel?
Answer 15. Although I have not had an opportunity to review the
report you cited, I believe that scientific expertise is critical to
ensuring appropriate input on scientific advisory committees, and I
will work to ensure that HHS advisory committees are appropriately
assembled.
Mental and Behavioral Health
Question 16. What do you see as the role of mental and behavioral
health services in federally supported health care programs?
Answer 16. In its report entitled ``Achieving the Promise:
Transforming Mental Health Care in America'' issued in July of 2003,
the President's New Freedom Commission on Mental Health established six
goals as a foundation for transforming mental health care in America.
The first goal was that ``Americans Understand that Mental Health Is
Essential to Overall Health.'' In its discussion of that goal, the
Commission discussed what a transformed mental health delivery system
would look like. Part of that discussion included the following
passage:
Effective mental health treatments will be more readily available
for most common mental disorders and will be better used in primary
care settings. Primary care providers will have the necessary time,
training, and resources to appropriately treat mental health problems.
Informed consumers of mental health service will learn to recognize and
identify their symptoms and will seek care without the fear of being
disrespected or stigmatized. Older adults, children, and adolescents,
individuals from ethnic minority groups, and uninsured or low-income
patients who are treated in public health care settings will receive
care for mental disorders.
The Substance Abuse and Mental Health Services Administration
(SAMHSA) was given lead responsibility for preparing a response to the
Commission's findings and recommendations. An Action Agenda was
prepared after consultation with 15 different Federal agencies. The
Action Agenda is expected to be released shortly.
Incorporated in this agenda are goals for integrating behavioral
health care into the primary health care system to provide greater
access to quality mental health care in keeping with goal 1 of the
Commission Report.
I look forward to sharing the Agenda with Congress as soon as it is
released.
Question 17. How can we ensure that the Medicaid waiver process
does not undermine critically needed mandatory mental health services,
such as those provided through Early and Periodic Screening,
Diagnostic, and Treatment (EPSDT)?
Answer 17. In general, I believe that EPSDT is a very important
benefit that must be preserved and protected for the most vulnerable
children--those with disabilities and those in families at the lowest
income levels. I also believe strongly that waivers provide States with
the flexibility to implement innovative ways to extend health coverage
to more people. This is a goal we should all support.
Flu Vaccine
Question 18. As you are well aware, our Nation recently suffered
its third flu vaccine shortage in four years. In order to forestall
such shortages, I have asked Secretary Thompson and HHS to implement
some of the recommendations of the Government Accountability Office
(GAO) regarding flu vaccine development and distributions. I would like
to know what measures you will take to ensure an adequate and safe flu
supply, in particular:
How will you develop a flu vaccine supply cushion, or otherwise
enable the Government to stockpile flu vaccine in case of emergency? In
what ways will you work to encourage increased research of alternative
vaccine production methods at the National Institutes of Health? How
will you improve the CDC's ability to track and distribute vaccine
throughout the United States in times of shortage? How will you improve
the ability of the FDA to expedite approval and safe importation of
excess flu vaccine from other nations? What are your plans for
encouraging drug companies to enter the flu vaccine market?
Answer 18. Preparation for the annual flu season has been a
priority at HHS. I will ensure that it continues to be a priority. I
believe that the CDC and FDA have successfully taken great strides
toward responding to an unforeseeable shortage of vaccine, through the
creation of tools to help States identify additional vaccine, through
the identification and purchase of additional vaccine under an
investigational new drug (IND) application, and through effective
public communication about the prioritization of high-risk groups who
should receive the available vaccine. Looking forward to the future, we
will continue to work with vaccine manufacturers to encourage them to
bring their vaccine for licensure and sale in the United States, as
well as taking longer-range steps to encourage the development of a
domestic vaccine supply, to ensure appropriate supplies of influenza
vaccine.
Pediatric Rule
Question 19. In 1998, the FDA adopted a ``Pediatric Rule'' that
required drug manufacturers to provide guidelines for the safe use of
their products by children. In order to codify the FDA authority to
require such action on behalf of companies, several of us from the HELP
Committee introduced the ``Pediatric Research Equity Act of 2003, which
has now become law. This law strengthens the FDA's power to ensure that
drugs that are marketed for pediatric populations are safe for use in
those populations. In February 2004, I sent a letter to Secretary
Thompson asking him how he planned to implement the Pediatric Rule
after concerns were raised in regards to the safety of antidepressant
use in children. I would like to learn about your position on these
issues as well. Specifically:
How can we further improve the FDA's current statutory
authorization to strengthen the safety and efficacy of pediatric drugs?
Answer 19. The Pediatric Research Equity Act of 2003 and the Best
Pharmaceuticals for Children Act of 2002 have provide FDA with valuable
tools to ensure the development of information on the safe and
effective use of pharmaceuticals products in pediatric populations. I
hope to more closely review these if confirmed as Secretary
Question 20. What steps do you plan to take to ensure that clinical
trial information resulting from pediatric studies will be available to
the children and families who would greatly benefit from such access?
Answer 20. FDA is committed to including appropriate information
related to the safe and effective use of drugs in pediatric patients in
approved drug labeling. In addition, when pediatric studies are
submitted to FDA as part if the pediatric exclusivity program under the
Best Pharmaceuticals for Children Act of 2002, within 180 days, the
agency publishes on the web () a summary of the medical and clinical pharmacology
reviews of the pediatric studies. In addition, when pediatric-specific
changes are made to drug labeling as a result of studies conducted for
pediatric exclusivity, FDA highlights these changes on its pediatric
web-site at http://www.fda.gov/cder/pediatric/labelchange.htm.
Open Access
Question 21. This past fall, NIH released a draft rule to improve
access to federally funded research literature. While I have supported
the concept of open access throughout this process, I think it is very
important that a deliberate and inclusive process is pursued to ensure
adoption of a policy that thoughtfully considers and appropriately
addresses the views of all those affected by it.
What will you do to ensure that this is the case, particularly in
light of suggestions that the delay of an announcement about the final
rule was designed to postpone any controversy over this issue until
after your confirmation?
Answer 21. I am not familiar with the details of the proposal, or
of where NIH stands as it works to finalize the proposal. Nonetheless,
in general, I believe that encouraging transparency and a public
dialogue in managing the taxpayer's investments at NIH are critical
steps to ensuring that the trust Congress has shown is maintained.
Comparative Effectiveness
Question 22. Comparative Effectiveness studies were included in the
final Medicare prescription drug law based on an amendment that
Senators Johnson and Bingaman joined me in offering during debate on
the bill. In December, AHRQ released its initial list of priorities for
this work.
In light of recent concerns over post approval drug safety, what
will you do to ensure that comparative effectiveness research is used
to help address this critical issue?
Answer 22. As you know, the MMA directed HHS to take important new
steps with regards to the comparative clinical effectiveness of
prescription drugs and other therapies. However, the MMA did not
include appropriations for these efforts. Accordingly, AHRQ and CMS
have taken steps to move forward as quickly as possible within those
constraints. This research is a priority for both AHRQ and CMS, and I
look forward to working with you as HHS moves forward on this.
______
Response to Questions of Senator Dodd
Ryan White CARE Act--Title IV
Question 1. The highly effective approach of family-centered care,
as practiced by grantees under Title IV of the Ryan White CARE Act, is
a model of efficiency that provides comprehensive medical and support
services to women, children, youth and families affected by HIV/AIDS.
Across the country, more than 53,000 people are served by 91 programs,
including specialized programs for HIV-positive adolescents and youth.
It is a critical program that must be maintained. If you prioritize the
reauthorization of the Ryan White CARE Act? Will you support
maintaining Title IV as an independent program that emphasizes the
importance of ``family-centered'' care? The past two fiscal years have
brought cuts to Title IV, despite its burgeoning caseload. Do you
support funding increases for Title IV? The HIV epidemic is growing
among young people in the United States, yet primary HIV prevention
programs at CDC targeting youth have been cut in recent funding cycles.
Do you agree we need additional resources for CDC's HIV prevention
programs for young people?
Answer 1. Thank you for your support for the Ryan White CARE Act,
which provides for the treatment of over 500,000 individuals living
with HIV/AIDS in the United States. The Administration continues to
finalize its assessment of the successes and drawbacks of the current
Ryan White CARE Act (RWCA) statute. Through the reauthorization
process, there are opportunities to strengthen the various RWCA
programs and to make them more effective. Treatment for people living
with HIV/AIDS has changed significantly since the last RWCA
reauthorization. If I am confirmed as Secretary, I will work hard to
ensure a successful reauthorization. I would expect that the structure
of the RWCA Titles may be part of the discussion during the
reauthorization process. As I am sure you are aware, the President laid
out the principles that will be used in guiding this process: 1) focus
federal resources on life-extending care and a core set of clinical
services, 2) provide greater flexibility to better target resources to
address areas of greatest need, 3) encourage participation of any
provider, including faith based and community organizations, that show
results, recognizing the need for State and local planning, and
ensuring accountability by measuring progress. The President's budget
will be delivered to Congress next month and will include continued
funding for all Titles of the Ryan White CARE Act.
As for HIV prevention programs at CDC, this is a high priority for
HHS and CDC and is reflected in the ongoing funding of State and local
health departments, community based organizations, and school health
programs. Much of the funding provided to State and local health
departments, as well as community organizations, for HIV prevention
efforts is directed towards programs serving youth and young adults.
HHS encourages community organizations serving youth to work with their
health departments to determine the best way to meet the HIV prevention
needs of young people in their communities. If I am confirmed, I will
stand ready to work with you to ensure that these programs continue to
help at-risk youth to stay healthy, reduce their risk, and remain free
of HIV infection, and to help young people already infected with HIV to
access the care, treatment, and support they need.
Pediatric Devices
Question 2. Governor Leavitt, as you may know, for almost the past
decade, this committee has taken the lead in ensuring that the drugs
children need are tested specifically for their use. Beginning with
legislation enacted in 1997 which created incentives for pediatric
studies (authored by myself and Senator DeWine) and continuing through
legislation enacted in 2003 requiring pediatric testing of certain
drugs (championed by myself, Senators Gregg, Kennedy, DeWine, Clinton,
and others) we have been working hard to ensure that children have the
same assurance of drug safety and efficacy that we expect as for
ourselves as adults.
As we're beginning to learn, however, this problem isn't confined
to drugs. Like with drugs, where for too long we assume that children
were small adults and could just take reduced doses of adult products,
we're finding that many essential medical devices used extensively by
pediatricians are not designed and sized for children's special needs.
Because the number of children needing a particular device is often
quite small, there's simply little financial incentive for
manufacturers to make pediatric appropriate devices. As a result,
health care providers are forced to use adult devices ``off-label''
without a clear understanding of the risks involved or to use older,
less optimal, or more invasive interventions. Pediatricians tell us
that the development of cutting-edge medical devices suitable for
children's smaller and growing bodies can lag 5 or 10 years behind
those for adults.
In my view, this is an issue that demands our attention. As
technology for prolonging and saving lives continues to advance at a
rapid pace, children are at risk of being left further and further
behind. It is my strong hope that this year we can come together on
bipartisan legislation to ensure that children are not an afterthought
when it comes to life-saving medical devices.
Governor Leavitt, I would be very interested in your views on this
issue. It would be my hope, if you are confirmed, that we could work
closely together on this very critical problem.
Answer 2. As you know, bringing pediatric medical devices to market
can be challenging for a number of reasons. Children are often smaller
and more active than adults, body structures and functions change
throughout childhood, and children may be long-term device users--
bringing new concerns about device longevity and long-term exposure to
implanted materials. In addition, modifying an adult device for
pediatric use may require significant re-designing of the device and
re-tooling of the manufacturing process. Conducting clinical trials in
children can also be more difficult due to the small patient population
and the variation within the population. I believe it is critical that
we work with FDA to encourage and support the development and
availability of safe and effective pediatric medical devices, and hope
to work with you in this area.
Medicare Modernization Act Implementation
Question 3. The new Medicare Part D prescription drug program will
begin in January 2006. To succeed, Medicare beneficiaries must receive
specific information regarding the plans available to them. The
information must be mailed to beneficiaries and include the drug
formularies in the plans available to each individual, what the co-
payments will be for each covered drug, how to enroll, and the
consequences of failing to enroll. Without this information
beneficiaries cannot make an informed choice.
Please tell me what you plan to do in order to provide this
information directly to each Medicare beneficiary. If you do not know
at this time, please confirm that you will mail specific information to
each beneficiary, that the information mailed will be particular to the
options available to each individual and that the information will be
detailed enough to allow the beneficiary to make an informed choice.
Answer 3. CMS will mail detailed comparison information about the
new prescription drug plans to all beneficiary households no later than
October 15, 2005, as required by the MMA, and will include the
information in our annual Medicare & You handbook, which allows CMS to
employ a tested production process and a trusted and recognizable
communication vehicle to get this information into the hands of
beneficiaries and help them make an informed choice. Handbooks have
specific comparison information for each beneficiary's geographic area
and the comparison data that is included is garnered from data that the
plan itself submits to CMS and has the opportunity to preview before
the mailing occurs. Additional detail will be available through the
individual plans, www.medicare.gov and 1-800-MEDICARE.
Further to the implementation of the Part D program:
Question 4. What particular outreach efforts will be made for hard-
to-reach populations, including those in nursing homes, those who are
eligible for both Medicaid and Medicare, those who speak other than
English as their first language, and those in rural areas?
Answer 4. Medicare's community-based outreach will work through the
Social Security Administration (SSA) and other Federal agencies,
States, employers, providers, pharmacists and other health care
stakeholders to reach beneficiaries through the various networks where
they obtain health care information. This local outreach will encompass
the hard-to-reach Medicare populations including those in nursing
homes, those who are eligible for both Medicaid and Medicare, those who
speak other than English as their first language, and those in rural
areas.
CMS will continue this local outreach through an expansive
grassroots campaign to educate Medicare beneficiaries at the local
level about the Medicare drug benefit. For example, CMS enhanced its
partnership with the State Health Insurance Assistance Programs
(SHIPs). HHS awarded $21.1 million in fiscal year 2004 and will award
another $31.7 million in fiscal year 2005 to the SCHIPs, thereby
reflecting the increased emphasis on one-on-one advice and counseling
for Medicare beneficiaries. The SCHIPs are among the most effective
resources in helping beneficiaries learn about the changes to Medicare
and will be able to use the additional funds to equip local
organizations with the tools needed to answer beneficiaries' questions.
CMS will also support an expansive network of local, community based
organizations to help educate and assist low-income beneficiaries who
may otherwise be hard to reach.
Question 5. What additional funding will be made to the State
Health Insurance Programs (SCHIPs) so that they will have sufficient
resources to help older people and people with disabilities understand
the new Part D program and make informed choices?
Answer 5. CMS has increased the funding for SCHIPs by awarding
$21.1 million in fiscal year 2004 and will award another $31.7 million
in fiscal year 2005 to the SCHIPs, thereby reflecting the increased
emphasis on one-on-one advice and counseling for Medicare
beneficiaries.
Global HIV/AIDS--Appropriate Pharmaceuticals for Pediatric Use
Question 6. Currently, few programs specifically target the
treatment of children with HIV/AIDS in developing countries. One of the
reasons for this is the lack of appropriate pharmaceuticals for their
use. Children are not small adults and treating them that way
jeopardizes their lives. With 2.5 million children infected with HIV
around the world, it is essential that we have appropriate medications
to treat them. How will you ensure that the HIV/AIDS drugs (both
generic and brand name) being approved by the FDA expedited process
will also include pediatric formulations, as well as important dosing
information needed for treating different age groups?
Answer 6. The pediatric exclusivity provision of the 1997 FDA
Modernization Act and the subsequent 2002 Best Pharmaceuticals for
Children Act have generated many clinical studies and useful
prescribing information for many products, including several for the
treatment of HIV infection. FDA has an HIV Written Request Template to
facilitate the development of products. Following are a few examples of
products that have been approved for treatment of HIV infection in
children. These approvals resulted from studies submitted in response
to a Written Request from FDA.
Ziagen (abacavir), Zerit (stavidine), Videx (didanosine), and
Viracept (nelfinavir mesylate), in combination with other
antiretroviral agents, are indicated for the treatment of HIV-1
infection in children. Use of Ziagen in pediatric patients aged 3-
months to 13 years is supported by pharmacokinetic studies and evidence
from adequate and well-controlled studies of Ziagen in adults and
pediatric patients. Use of Zerit in pediatric patients from birth
though adolescence is supported by evidence from adequate and well-
controlled studies of Zerit in adults with additional pharmacokinetic
and safety data in pediatric patients. Use of Videx in pediatric
patients two weeks of age through adolescence is supported by evidence
from adequate and well-controlled studies of Videx in adults and
pediatric patients. Use of Viracept in pediatric patients from age 2 to
age 13 is supported by evidence from adequate and well-controlled
studies of Viracept in adults with additional pharmacokinetic and
safety data in pediatric patients.
In addition, in March 2003, the Pediatric Subcommittee of the
AntiInfective Drugs Advisory Committee, of the Food and Drug
Administration, Center for Drug Evaluation and Research discussed the
development of antiretroviral drugs in HIV-infected and HIV-exposed
neonates younger than four weeks of age. The Advisory Committee
supported the continued need for development of products for neonates.
These are just a few examples demonstrating FDA's commitment to the
principle that product development should include pediatric studies
when pediatric use of the product is intended. In addition, through
efforts to make safe and effective antiretrovirals available for
treatment of HIV across much of the developing world, we expect to
reduce the number of children born with HIV infection and thus
significantly impact global health.
If confirmed as Secretary of HHS, I will work to ensure that FDA
builds on this strong record of review of HIV treatments suitable for
children.
Mercury/Environmental Health
Question 7. The Environmental Protection Agency (EPA), under your
leadership, is poised to finalize a regulation that would establish a
market-based trading program for the regulation of mercury emissions
from coal-fired power plants. The trading regime would reduce emissions
from the industry overall, but would allow some plants actually to
increase their mercury emissions. Unlike emissions of substances like
carbon dioxide, mercury emissions are believed to have at least some
local impacts. In addition, mercury is believed to be toxic to
children.
Governor Leavitt, there is a growing body of evidence that
environmental factors have a profound impact on children's health. I am
concerned that your actions as EPA Administrator in regards to mercury
suggest insensitivity to this issue. As Secretary of HHS, what would
you do to protect children from mercury and other environmental hazards
that cause conditions from asthma to impaired neurological development?
Answer 7. During my tenure at EPA, and especially during the
development of the first-ever rule to regulate mercury emissions from
power plants, I have been committed to protecting the public health of
all citizens and the environment. To that end, I outlined five
principles that provided a context for additional inquiry and help
focused the Agency's deliberations as it moves toward the mercury final
rule in March of this year. The protection of children and pregnant
women from the health impacts of mercury were at the forefront of these
five principles.
As you may know, we have coordinated the implementation of the cap-
and-trade approach for regulating mercury from utility units with the
Clean Air Interstate rule proposal (CAIR), which is designed to
dramatically reduce and permanently cap the emissions of sulfur dioxide
(SO2) and nitrogen oxides (NOx) in 29 Eastern States. We believe that a
multi-pollutant approach to regulating SO2, NOx, and mercury from the
utility sector provides a cost-effective and environmentally beneficial
strategy for reducing air pollution from the sector.
As a general matter, a cap-and-trade system requires emissions
reductions on a concrete timeline of declining caps, thus leading to
continual reduction of emissions and promotion of new technologies.
Further, the largest emitters typically will be the first to reduce
their mercury emissions and will generally achieve the greatest level
of reductions. More specifically, it is my understanding that in
implementing cap-and-trade programs in the past, we have not observed
the creation of hot spots. Even so, the proposed trading programs
provide legal mechanisms to ensure that should hot spots be identified,
appropriate Federal and/or State actions are allowed to address them.
Historically, EPA has seen the largest emitters attempt to control
emissions sooner in a cap-and-trade program because of the economies of
scale and the ability to bank allowances for later years. Thus, we
believe such a program creates incentives for the utility sector to
aggressively seek reductions in NOx and SO2, which ultimately provide
early mercury reductions.
As Secretary of HHS I would continue the Department's commitment to
safeguard the environmental health of children, through support of
several ongoing programs to advance the scientific understanding of
health impacts from exposure to hazardous substances, including
mercury, and to protect children from exposure to environmental
contaminants with potentially adverse health impacts.
______
Response to Questions of Senator Harkins
Obesity Crisis
Question 1. Health care costs are skyrocketing and chronic
conditions like obesity and smoking are major contributors. We have one
of the best medical systems in the world to treat people but
unfortunately it does little in terms of prevention. Obesity has become
an epidemic in this country and is especially worrisome when it comes
to children. The direct and indirect costs of obesity are more than
$117 billion annually according to the Department you will now lead.
Yet, there is no single Federal agency with the responsibility and
authority to handle the crisis. While obesity is a complex public
health problem, many agree that a comprehensive plan is necessary to
combat the growing epidemic.
Do you envision creating a command and control center at CDC to
develop a Federal game plan for preventing and controlling obesity and
related chronic diseases like diabetes and heart disease? If not, how
do you propose to address the Nation's obesity epidemic? How
specifically will you work with other Federal agencies?
Answer 1. Seven of nine of the major causes of death in the United
States are caused by chronic diseases. The underlying causes of these
diseases are often behaviors that can be successfully modified thereby
reducing illness and death. Three factors--lack of physical activity,
poor nutrition, and tobacco use--are major contributors to the Nation's
leading killers; heart disease, cancer, stroke, chronic obstructive
pulmonary disease and diabetes. Too, the prevalence of overweight has
more than doubled in children and tripled in adolescents; indicators
suggest that diabetes too is increasing among children. This is
particularly troubling given obesity is a co-morbidity factor leading
to significantly increased risk of death due to cancer, heart disease
and diabetes.
In June 2002, President Bush launched the HealthierUS initiative to
utilize the combined expertise of the Federal Government to help
Americans live longer and healthier lives through simple changes in
their everyday lives. The four pillars of the HealthierUS initiative
are: 1) be physically active every day; 2) eat a nutritious diet; 3)
get preventive screenings; and 4) make healthy choices concerning
alcohol, tobacco, drugs and safety.
HHS is currently engaged in a number of key activities, two of
which are listed below. I look forward to examining what has been done
and what is underway, and working to continue this tremendous progress.
Current Activities:
Steps to a HealthierUS Initiative (Steps). Steps
specifically targets diabetes, asthma and obesity. In fiscal year 2003
Steps funded 23 communities. In fiscal year 2004 the program awarded
$44 million to help 16 additional communities develop action plans to
implement programs that promote disease prevention and health; the
total number of funded communities is 40. Steps also received $1.5
million to fund one national program, YMCA's Activate America. Fiscal
year 2005 appropriations budget for Steps is approximately $47 million.
National Coverage Decision--Earlier this year, HHS
announced a new Medicare coverage policy that would permit Medicare to
cover anti-obesity interventions if scientific and medical evidence
demonstrate their effectiveness in improving Medicare beneficiaries'
health outcomes. The new policy removes language in the Medicare
Coverage Issues Manual stating that obesity is not an illness, allowing
Medicare to determine if specific obesity-related treatments should be
covered by Medicare.
Parity Between Disease Prevention and Treatment
Question 2. As you know, the United States spends more than $1.5
trillion each year on health care. That figure has doubled over the
past 5 years, and if current patterns hold, is expected to double again
within 6 years.
The consequences of future increases are clear: More Americans will
be left without access to health care, and more communities will suffer
the closure of local hospitals and clinics. As a result, many Americans
will forgo basic health maintenance visits, making it more likely that
illnesses will go undiagnosed at early stages--a situation that will
send health care costs spiraling even further.
In my view, one way to reduce the long-term burden of disease is to
invest in preventing disease at the outset. This involves research to
determine the best methods to convince Americans to adopt healthy
lifestyles and grassroots programming to get the results of that
research into our communities.
To what extent will you focus the efforts of the Department on
population-based public health research and prevention programs such as
that conducted by CDC and NIH?
Answer 2. I believe, as you do, that disease prevention is an
important tool that we can use to reduce the long-term burden of
disease. You raise an important question of focusing efforts in this
area that I will consider carefully if confirmed as Secretary.
Question 3. A brief glance at the Department's budget proves that
Federal resources are disproportionately skewed away from disease
prevention and toward treatment of illness and disease. In 2003,
Federal spending on health care programs run by the Centers for
Medicare and Medicaid services totaled $414 billion. In 2003, federal
spending on major disease prevention and health promotion programs
totaled $42 billion, or just about ten 10 percent.
A greater investment in prevention will ultimately yield tremendous
savings in human suffering and financial cost. Have you given any
thought as to how you might make disease prevention a centerpiece of
the Department's vast and diverse portfolio?
Answer 3. As you know, many of our Nation's leading health
challenges are preventable diseases. Focusing efforts on prevention can
pay key dividends. I know that the recently enacted MMA included
important provisions in this area, and that prevention has been a
growing area of focus for HHS. I look forward to carefully examining
this issue more fully if confirmed as Secretary.
Need to Increase Access to Community Based Services for People With
Disabilities and Older Americans
Question 4. We are currently spending approximately 70 percent of
our long-term care Medicaid dollars on institutional settings and only
30 percent on home and community based services. There needs to be
increased access to home and community based services so Americans with
disabilities and older Americans can choose where they want to live and
not be forced into segregated settings away from family and friends.
How will you expand the long term care system to assure no person
is forced into a nursing home or other institution because of the lack
of home and community service and support options? What policies will
you propose?
Answer 4. I firmly believe that individuals who are able to receive
long term care services and supports in the community have increased
satisfaction, lower incidence of care neglect, lower incidence of
adverse effects and health problems; and lower unmet needs. While
community-based care is not for everyone, I support policy options to
make the choice available to individuals with disabilities and the
elderly population.
CMS is currently working with several States interested in using
the 1115 waiver authority to develop long-term care systems that
tighten the standard for institutional care while making home and
community-based services more readily available. As States have
developed effective ways to rebalance State long-term care systems, CMS
is sharing that information with other States to enable them to
rebalance their systems. As Secretary, I will work with States to use
the flexibilities permitted in Medicaid to rebalance State long-term
care systems.
Question 5. The Supreme Court ruled in the Olmstead case that
people with disabilities have a right to services and supports ``in the
most integrated setting''. What will you do as Secretary to assure that
States are complying with the Olmstead decision and that Medicaid long
term care funds are spent so people with disabilities have a choice to
receive services and supports in the most integrated setting?
Answer 5. As Secretary I will ensure that the Department continues
to take a leading role in carrying out the President's New Freedom
Initiative, including its commitment through Executive Order 13217 to
implement the Olmstead decision to ensure that individuals with
disabilities receive services in the most integrated setting. The
Executive Order commits the United States to a policy of community
integration for individuals with disabilities and calls upon the
Federal Government to work with States to implement the Supreme Court's
decision in Olmstead v. L.C. As part of the Executive Order, the
President directed the Secretary of HHS to coordinate the activities of
other Federal agencies. This coordinated effort led to the production
of Delivering on the Promise, a comprehensive compilation of the
reports of nine Federal agencies outlining more than 400 specific steps
the agencies will implement to support community living for the nearly
54 million Americans living with disabilities. The Office on Disability
was created at HHS to coordinate the Department's commitments, and I
will ensure that the Department continues to place these activities
among its highest priorities. Additionally, OCR will continue to
provide technical assistance to States as they continue developing
comprehensive, effectively-working plans to integrate persons with
disabilities into communities and to resolve voluntarily complaints
filed by or on behalf of persons with disabilities.
Medicare
Question 6. Iowa ranks at the bottom of all 50 States on per
beneficiary Medicare reimbursement, even though medical facilities in
Iowa provide high quality care. While I understand that this is due in
large part to the relative cost of performing these services, I am
concerned that this reimbursement provides a disincentive for health
care professionals to remain in the State. In addition, I am concerned
that any further cuts in provider payments will make this situation
untenable.
How do you plan to link Medicare reimbursement with quality
services and outcomes?
Answer 6. Encouraging improved health care quality is a top
priority of mine and of the President's. The Administration has
promoted accountability for quality, creating incentives to collect
data from Medicare providers on quality measures. I am intrigued by the
possibility of approaches to link Medicare reimbursement to provider
performance. While I certainly am not versed in the variety of ways
that pay-for-performance could be incorporated into the Medicare and
Medicaid payment systems, I am excited to be involved in conversations
regarding the issue. If I were to be confirmed, I would expect the
Department would continue to review this issue and I would want us to
work with the provider and beneficiary communities and the Congress in
doing so.
Question 7. Do you think, from the administration's perspective, in
order to reduce the budget deficit in half in five years, that provider
payments cuts will be part of any administration proposal to change
Medicare? And, if so, what can be done to mitigate this problem for
rural providers.
Answer 7. As you know, I have not been part of discussions on
forward-leaning budgets, but I am aware of the sensitivities
surrounding provider payments and the challenges that rural providers
face and will be sensitive to those issues.
Dietary Supplements
Question 8. As an author with Senator Hatch of the Dietary
Supplement Health and Education Act of 1994, I wanted to get your
response to several questions regarding the regulation of dietary
supplements. First, as you know, after many years of delay, final good
manufacturing practices regulations are near completion. Can you assure
me that these regulations will be published in the next 30 days?
Answer 8. If confirmed, I will look into the status of these
regulations and work with FDA to see them completed as quickly as
possible.
Question 9. Second, as you may know, DSHEA was passed unanimously
by both the House and Senate. This unanimity of support reflected the
Act's careful balance of maintaining consumer access to a range of
healthful products, improving the quality and availability of reliable
scientific information on supplements, and providing regulatory
authority adequate to assure the protection of the public health. Do
you agree with me that DSHEA provides an appropriately balanced
regulatory structure when fully implemented and enforced? Or do you
believe it should be amended to provide the Department with additional
regulatory authority over the manufacture and sale of dietary
supplements?
Answer 9. If confirmed as Secretary, I will carefully evaluate the
need for any additional authority relating to this issue.
As you may know, FDA recently published a new strategy to
strengthen its regulation of dietary supplements. FDA's strategy for
dietary supplements outlines the steps it plans to take to continue
implementing and enforcing the Dietary Supplement Health and Education
Act of 1994 (DSHEA). The strategy sets forth a series of research and
measures, including guidance, regulations, and science-based compliance
and enforcement mechanisms.
The strategy focuses on three areas: monitoring and evaluating
product and ingredient safety, ensuring product quality, and monitoring
and evaluating product labeling. With this strategy, FDA hopes to
improve the transparency, predictability, and consistency of the
Agency's scientific evaluations of dietary supplement product and
ingredient safety. The actions outlined in the strategy are also
designed to protect consumers against unsafe dietary supplements and
dietary supplements making unauthorized, false, or misleading claims.
FDA expects that this improved transparency will help engage
stakeholders in the development of further measures to implement DSHEA.
______
Response to Questions of Senator Jeffords
Question 1. Last December, the FDA's Independent Expert Advisory
Committees were unanimous in their determination that Plan B is safe
enough for over-the-counter use, and that there is no data to show that
Plan B leads to substitution of emergency contraception for other
methods of contraception. Despite this determination by the Advisory
Committees, the FDA denied Plan B Over-The-Counter status and overrode
the overwhelming scientific evidence.
I am concerned that the FDA decision was based more on ideology
than science. Governor Leavitt I am interested in what actions you
would take to ensure that FDA decisions are based on scientific
evidence and not political ideology?
Answer 1. I am committed to the principle that regulatory decisions
should be based on the best scientific information that is available.
As you know, the FDA previously denied an application to change this
drug to over-the-counter status, because adequate data were not
provided to support a conclusion that young adolescent women can safely
use Plan B for emergency contraception without the professional
supervision of a licensed practitioner.
I understand that the sponsor has subsequently submitted a new
application, and that the application is being reviewed by the
scientists at FDA--and that action is due on this application soon.
Question 2. In August of 2004, the Drug Enforcement Administration
(DEA) forwarded a petition to reschedule marijuana to the Department of
Health and Human Services (HHS). The DEA requested from HHS a
scientific and medical evaluation of marijuana, upon which it would
base its decision as to whether to reschedule marijuana. By law, the
Secretary of HHS is required to conduct this evaluation ``within a
reasonable time.''
As you may know, 10 States, including my home State of Vermont,
currently allow for the medical use of marijuana, while the Federal
Government does not. To address this discrepancy, the HHS evaluation
needs to move forward. Governor Leavitt, can you work to ensure that
this evaluation is completed by August 2005, 1 year after the request
was received by HHS? If not, could you please explain what you would
consider a ``reasonable time'' for this evaluation to be?
Answer 2. FDA is currently reviewing the scientific data and must
conduct a scientific and medical evaluation of marijuana in accordance
with the statutory criteria and make a recommendation to DEA. We will
make every effort to complete the evaluation by August 2005.
______
Response to Questions of Senator Kennedy
Medicaid
Question 1. At the hearing you talked about your desire to give
governor's greater flexibility in Medicaid, so that they can cover more
people. Covering more people is a laudable objective and additional
resources to do it are essential, but flexibility that results in
reduced services or coverage for the most needy and sickest members of
our society is not desirable. Specifically, some who advocate increased
flexibility have favored abolishing EPSDT services for poor children.
EPSDT requires the coverage of medically necessary services for
children even if those services are not normally covered under the
State Medicaid plan. The children who benefit from this rule are
typically children with disabilities or special needs who need services
that are not normally covered by a typical insurance policy.
Do you think that removing a guarantee of needed health services
for poor children with serious disabilities is the right priority for
our country?
Answer 1. EPSDT is a very important benefit that should be
preserved and protected for the most vulnerable children--those with
disabilities and those in families at the lowest income levels who meet
the federally mandated eligibility groups in Medicaid.
Women's Health
Question 2. Congressman Henry Waxman recently released a report
showing that the curricula used in the largest abstinence-only
education program, and other federally funded programs are not reviewed
for accuracy by the Federal Government. The report finds that over 80
percent of the abstinence-only curricula, used by over two-thirds of
the Community Based Abstinence Education grantees in 2003, contain
false, misleading, or distorted information about reproductive health.
It is essential to separate ideology from sound science and provide
clear and accurate sex education for our children. What will you do to
provide effective oversight of these programs and ensure accuracy and
integrity of the sex education curricula?
Answer 2. I share your interest in the Community-Based Abstinence
Education programs and the need to provide sound and medically accurate
information to our Nation's youth. I also agree with the President that
the only 100 percent sure way to prevent unwanted pregnancies and
sexually transmitted diseases is sexual abstinence. I look forward to
working with you on helping our Nation's youth make the best choices
for themselves.
Question 3. Title X of the Public Health Service Act, the
cornerstone our Nation's family planning program, serves 5 million
women each year at more than 4,500 clinics across the Nation that are
run by abroad range of local providers, including hospitals, health
departments, and local non-profit agencies. Investments in
contraception are among the most cost-effective health services. For
every dollar spent on publicly funded family planning services, three
dollars are saved in pregnancy-related and newborn care costs to
Medicaid.
Despite the proven cost-effectiveness of family planning services,
Title X has a very small appropriation of only $288 million, even
though the program has an excellent track record of providing low
income Americans with subsidized, confidential health care services
such as pap tests, birth control, and screening and treatment for STDs
and helps women to avoid over one million unintended pregnancies each
year.
Can you give us your assurance that maintaining the integrity of
Title X and its commitment to providing critical contraceptive and
related services to low income women will be a top priority for you and
the department?
Answer 3. I can assure you that I will require the highest degree
of accountability and integrity from Title X, and other Federal
programs that provide family planning, and that reducing health care
disparities for minority populations and low income families will
continue to be a priority for the department during my tenure as
Secretary.
Public Health
Question 4. Two-thirds of Americans are overweight or obese, and
the problem is growing, particularly in minority populations. Rates of
obesity in children have doubled, and even tripled in some age groups
over the past 20 years. As a result, children are increasingly
developing diseases like diabetes and hypertension that used to be seen
mostly in adults.
Last week, HHS and the Department of Agriculture released ``Dietary
Guidelines for Americans'', which recommend eating more fruits and
vegetables, low-fat milk, whole grains, and exercising more often. The
guidelines specifically recommend limiting consumption of sugars and
trans fats. However, as the report states, the publication is not aimed
at the general public, unlike previous versions, and no funds are
designated to promote the guidelines or disseminate the information to
the public in useful ways.
What steps will you take to make the information in these
guidelines available in ways that help people practice what the
guidelines preach?
Answer 4. The Dietary Guidelines, based on the latest scientific
and medical information, provides authoritative advice about how proper
dietary habits can promote health and reduce risk for major chronic
diseases. Consumer-friendly materials such as brochures and Web sites
will assist the general public in understanding the scientific language
of the 2005 Dietary Guidelines and the key points that they can apply
in their lives. To highlight those points, a consumer-oriented brochure
accompanies the 2005 Dietary Guidelines. USDA's Food Guidance System
also will serve as a tool to educate consumers on the Dietary
Guidelines for Americans. The Food Guidance System, currently called
the Food Guide Pyramid, is undergoing revision and will be released in
the spring of 2005.
Question 5. The National High Blood Pressure Education Program at
the NIH has said that the food industry must reduce the sodium content
of processed foods because such reductions could save tens of thousands
of lives per year by lowering high blood pressure. How do you intend to
work with the food industry to reduce the salt in processed foods?
Answer 5. I believe that HHS has done a tremendous job in focusing
public attention on the issues relating to wellness, prevention and
obesity, and that these efforts are bearing fruit. As part of these
efforts, HHS has been able to work collaboratively with outside
stakeholders, including the food and restaurant industry, to make
important progress. An example of this is the improved nutritional
labeling information that is available through many restaurants. I hope
to continue this collaborative approach and work with all interested
parties to improve the health of the Nation.
Question 6. In a 2004 report on the labeling of sugars and other
nutrients, the Institute of Medicine recommended that providing
information to consumers about sugars or added sugars in the context of
a total daily diet ``should be an urgent consideration of the cognizant
regulatory bodies.'' How do you believe the FDA should respond to this
IOM recommendation?
Answer 6. The 2005 Dietary Guidelines for Americans recommends that
consumers limit consumption of added sugars in foods and beverages. The
Dietary Guidelines present the concept of ``discretionary calories'' as
a way for consumers to understand the amount of added sugars that could
be incorporated into a healthful diet and also the concept of nutrient
dense foods as a way to choose products that are good sources of
nutrients compared to their calorie content. The Nutrition Facts panel
of food labels provides consumers with information on the total sugars
in a product and the ingredient list provides information on what is in
a product, including ingredients that are sources of added sugars. FDA
can help consumers respond to the recommendations in the IOM report as
well as the Dietary Guidelines by educating consumers on how to use the
Nutrition Facts panel and ingredient list to determine which foods are
high in added sugars.
Question 7. The Centers for Disease Control released a
comprehensive report on the state of health of African Americans, which
outlined severe and pervasive disparities in health between African
Americans and whites Americans. You mentioned that expansion of health
insurance coverage would be one way to reduce health disparities. What
additional programs and policies will you support to eliminate racial
and ethnic disparities in health and health care? What work has been
conducted or completed by the HHS Disparities Council in this area? Who
are the members of the HHS Disparities Council?
Answer 7. We have experienced remarkable achievements in the health
of this Nation. However, some Americans have not benefited equally. As
you correctly indicate, it is well documented that racial and ethnic
minorities, as well as some geographically and socio-economically
disadvantaged populations, suffer a greater burden of illness and
premature death in this country. These disparities in health are
persistent, in some cases are widening, and are simply unacceptable. We
must take action if we are to remain healthy, strong, and vibrant as a
nation. I want you to know that disparities in health is a challenge
that I have taken to heart.
The President and his Administration have made the elimination of
health disparities in our country a priority, and I am also committed
to making this happen. I intend to work with the Department's Health
Disparities Council, which consists of senior representatives of each
agency and staff division of HHS, to focus time and attention on ways
to make sure communities of color and other disadvantaged populations
have access to quality health care and are getting the very best health
information. We will continue to expand on those efforts that have
resulted in improved health outcomes as well as identify new approaches
to closing critical health gaps.
Question 8. Approximately half the U.S. supply of flu vaccine is
unusable because of manufacturing problems at a facility in Britain
operated by the Chiron Corporation. I am concerned that FDA appears to
have known of problems in vaccine production at the facility many
months before it was shut down by the British regulatory agency, but
took little action to correct the problems. To determine what actions
FDA took or failed to take, I requested documents to show FDA's
communications with Chiron regarding its production of flu vaccine. I
was disappointed to receive only 229 pages of documentation, which
included 26 pages that were blank or contained material, such as press
releases, that were already in the public domain. Over 850 additional
pages--more than 80 percent of the total relevant documents--were
withheld and not released to me. That is the nature of the withheld
documents and why have you deemed them to be ``not releasable?''
Answer 8. Your request for documents relating to the suspension of
Chiron Corporation's influenza vaccine manufacturing license by the
United Kingdom's Medicine and Healthcare Products Regulatory Agency
covered a very large volume of documents. I understand that FDA
provided a partial response to your request on January 10, 2005.
The information redacted from the documents enclosed in the January
10 letter was commercial confidential and other privileged information
protected from disclosure under the Freedom of Information Act (Title
5, United States Code section 552) and FDA regulations.
Question 9. What steps did the FDA take to monitor Chiron's
production process after the delay in shipping due to contaminated lots
in August 2003? Please describe in detail any inspections of the
Liverpool plant and communication with Chiron employees and British
regulators.
Answer 9. I believe that your question relates to contaminated lots
identified in August 2004, not August 2003. On August 25, 2004, Chiron
informed FDA that the company had discovered bacterial contamination in
eight lots of final vaccine product for this year's flu season supply
and advised that they were investigating the problem. They shared with
FDA an overview of their planned investigation to determine root causes
of the problem as well as their plan to retest all other lots produced.
Chiron quarantined all influenza vaccine lots during its investigation,
including those that had passed all required testing, and did not
release any of the product.
In September 2004, FDA, CDC and Chiron scheduled weekly conference
calls to discuss the status of the firm's investigation. Chiron stated
to FDA that the company thought it had identified the cause of the
contamination and that the contamination was confined to the identified
vaccine lots. Nonetheless, FDA concurred with the need for Chiron to
thoroughly retest all final lots, complete a thorough investigation of
the manufacturing process and provide a complete investigation report
to FDA. While the investigation was ongoing, Chiron informed FDA that
results of the retesting were negative and that the company would
submit its final investigative report to FDA during the week of October
4-8.
In late September, Chiron advised that it would substantially meet
its obligations to supply influenza vaccine to the United States. On
September 28, Chiron's CEO affirmed this in testimony to the Senate
Committee on Aging when he stated: ``As of September 27th, it remains
Chiron's expectation that between 46 million and 48 million Fluvirin
doses will be delivered to the U.S. market beginning in early October
as compared to the 50 million doses projected in July.''
FDA inspected the Liverpool, U.K. facility where this vaccine is
produced in 1999, 2001, 2003, and 2004. Under Agency enforcement
policy, FDA inspects U.S. licensed vaccine manufacturing facilities
every two years. Please note that Chiron acquired the facility in July
2003 after FDA conducted the biennial inspection. During the 1999
inspection, FDA identified various concerns and, as a result, issued a
warning letter regarding the Liverpool facility. The most significant
issues identified in 1999 were the lack of validation for its
manufacturing processes, including establishing proper limits for
bioburden (including bacteria) and issues related to assuring sterility
in the manufacturing process. During the 2001 and 2003 inspections,
although FDA found that the company made improvements, we also made
observations related to current Good Manufacturing Practice (cGMPs). In
each case, FDA reviewed the corrective measures and plans in response
to these deficiencies. If fully implemented, the company's plans
appeared adequate to correct deficiencies identified at the facility.
1999 and 2001 Inspections
An inspection of the firm on July 13 through July 21, 1999,
resulted in the issuance of a Warning Letter on October 21, 1999. The
firm responded to the Warning Letter on November 15, 1999. A response
review letter was issued to the firm on March 1, 2000, which included
requests for additional information. The firm provided the additional
information in a letter dated April 6, 2000. A second response review
letter was issued to the firm on May 24, 2000, which included
additional comments and also stated that the adequacy of the firm's
responses would be verified during the next inspection.
The inspection of Evans Vaccines Ltd., operating as a division of
PowderJect Pharmaceuticals Plc., performed February 26 through March 9,
2001, was conducted in part as a follow-up inspection to the Warning
Letter and as a routine CGMP inspection. As stated in the establishment
inspection report (EIR) for this inspection, the firm's corrective
actions taken in response to the Warning Letter were reviewed and
evaluated and appeared to be adequate with the exception of the
cleaning validation of a filtration unit. The cleaning validation was
not complete and further studies were needed to assure the completeness
of sterility test failure investigations.
The February 26 through March 9, 2001, inspection was classified
voluntary action indicated (VAI). On March 9, 2001, a 31-item, Form FDA
483 was issued to the firm. The CGMP deviations included no data to
support holding times, inadequate cleaning validation studies, failure
to follow SOPs, inadequate failure investigations, inaccuracies noted
in the Master Production Records, tubing used for transfer touching the
floor, no SOP for Biological Product Deviations, inadequate validation
for a vial filler, inadequate preventive maintenance program,
inadequate validation for vial and stopper washing, process
qualification for WFI system not reviewed and approved by the Quality
Control Unit and testing to determine compatibility of equipment.
The firm responded to the Form FDA 483 items on April 20, 2001. The
response stated corrective actions including the modification and
enhancement of SOPs, purchasing of new equipment, enhancement of
Quality Control Unit, and training/retraining of personnel. A response
review letter was issued to the firm on July 19, 2001, which included
comments and also stated the firm's responses appeared adequate and
that the implementation and effectiveness would be verified during the
next inspection.
The inspectional observations made during the February 26 through
March 9, 2001, inspection were deviations from CGMP and were adequately
addressed by the firm in the April 20, 2001, response.
2003
The inspection of Evans Vaccine, Ltd., operating as a division of
PowderJect Pharmaceuticals Plc., performed June 2 through June 10,
2003, was conducted as a routine CGMP inspection. As stated in the EIR,
the inspection disclosed that the firm had corrected most of the
observations cited during the February 26 through March 9, 2001,
inspection with the exception of the cleaning validation of a
filtration unit, inaccuracies in the Master Production Records,
validation for a vial filler, and testing to determine compatibility of
equipment.
The June 2 through June 10, 2003, inspection was classified VAI. On
June 10, 2003, a 20-item, Form FDA 483 was issued to the firm. The
majority of observations cited during the inspection were regarding
issues and lots manufactured in 2000, 2001 and 2002. The CGMP
deviations included reprocessing of monovalent blends for 2001/2002
campaign lots without prior approval, inadequate failure investigations
for 2000/2001 and 2001/2002 campaign lots, incomplete sterility failure
investigations for monovalent blend pools for 2000/2001 and 2001/2002
campaign lots, deficiencies in product contact equipment compatibility,
incomplete Biological Product Deviation (BPD) reporting, inadequate
cleaning validation studies, failure to follow SOPs, deficiencies in
filling room operations, inadequate validation of sanitizer efficacy,
deficiencies in media fill simulations, and no documentation of adverse
events for 2002/2003 campaigns.
The firm responded to the Form FDA 483 on June 27, 2003. The
response stated corrective actions including a commitment to quality
system improvements, an enhanced program to ensure consistency of
application of CGMPS across all sites, ongoing global initiative for
the company, incorporation of ``Quality System Improvement Program''
(QSIP), and the use of a U.S. consultant to assist the firm. In
addition, the response stated that as of April 12, 2002, no
reprocessing of monovalent blend lots had occurred for lots destined
for U.S. market and committed to revising the SOP. Moreover, as stated
in the firm's response and as the evidence collected during the
inspection clearly showed, there was a steady decrease in bioburden
level excursions from 2001 up to June 2003. This indicated that
corrective actions taken as a result of the bioburden level excursions
seemed to be effective.
A response review letter was issued to the firm on September 3,
2003, which stated the adequacy of the firm's responses would be
verified during the next inspection.
The inspectional observations made during the June 2 through June
10, 2003, inspection were deviations from CGMP and were adequately
addressed by the firm in the June 27, 2003, response.
2004
The inspection of Evans Vaccines Ltd., operating as an affiliate of
Chiron Corporation, performed October 10 through October 15, 2004, was
conducted in part as a follow-up to the MHRA flu vaccine license
suspension and as a routine CGMP inspection. As stated in the EIR, the
inspection disclosed that 5 out of the 20 observations made during the
June 2003 inspection had not been adequately corrected which included
inadequate failure investigations for 2000/2001 and 2001/2002 campaign
lots, incomplete sterility failure investigations for monovalent blend
pools for 2000/2001 and 2001/2002 campaign lots, deficiencies in
product contact equipment compatibility, deficiencies in media fill
simulations, and no documentation of adverse events for 2002/2003
campaigns.
The October 2004 inspection disclosed deficiencies in the control
of bioburden in the manufacturing and production areas, which were not
seen during the June 2003 inspection. The October 2004 inspection
disclosed that over 50 percent of the monoblend pools used from March
2004 through October 2004 exceeded the firm's bioburden alert level. In
addition, nine batches of final product were rejected for sterility
failures, and four other batches of final product were rejected within
two months, from September 2004 to October 2004, due to environmental
excursions.
The October 10 through October 15, 2004, inspection was classified
official action indicated (OAI). On October 15, 2004, a 14-item, Form
FDA 483 was issued to the firm. The inspection resulted in the issuance
of a Warning Letter on December 9, 2004. The CGMP deviations included
failure to establish an adequate quality control unit, failure of the
quality control unit to review records to assure no errors have
occurred, or, if errors have occurred, that they are fully
investigated, failure to follow written procedures applicable to the
function of the quality control unit, and failure to establish,
implement, and follow scientifically sound and appropriate
specifications, standards, sampling plans, and test procedures.
The firm responded to the investigational findings by meeting with
the FDA on November 9, 2004, and with a written response on November
13, 2004. Comments to the firm's response and requests for additional
information were included in the December 9, 2004, Warning Letter.
Chiron responded to the Warning Letter on January 7, 2005. The response
is under review at FDA.
Communications With MHRA
On the morning of October 5, 2004, MHRA announced a three-month
suspension of Chiron's license to manufacture influenza vaccine. FDA
had no prior knowledge of the MHRA's intention to suspend the firm's
U.K. license. MHRA's Chief Executive, Professor Kent Woods, indicated
that MHRA did not have the legal authority to notify FDA about the
suspension announced on October 5 until after MHRA instituted its
administrative action. Dr. Woods has also stated that, ``Contrary to
some reported statements, MHRA, as the responsible regulatory authority
in the United Kingdom, made the decision to suspend Chiron's license
after an internal meeting on October 4 and first informed the company
and the FDA of this decision on October 5. At the same time, we
informed other drug regulatory authorities via an intergovernmental
rapid information alert.''
Upon learning of the MHRA's suspension, FDA communicated with both
Chiron and the MHRA. While Chiron indicated to FDA that it believed it
had satisfactorily addressed MHRA's inspectional findings and provided
to FDA a copy of those findings and the company's response, MHRA
expressed serious concerns about Chiron's vaccine stocks and the
company's ability to assure the safety of the vaccine.
FDA will continue to work with Chiron and the U.K. government to
ensure that the company corrects the deficiencies in the Liverpool
plant so that it can eventually resume production of a safe and
effective influenza vaccine. Subsequent to MHRA taking its action to
suspend Chiron's license to manufacture influenza vaccine at the
Liverpool facility, Chiron gave MHRA and FDA permission to discuss the
issues related to Chiron that are considered confidential commercial,
trade secret and proprietary. FDA is also working to implement an
information sharing agreement with MHRA that would, among other things,
permit advance communication on important issues.
Question 10. During the weekly telephone calls with Chiron in
September 2003, did the FDA have the opportunity to review the actual
data obtained from the re-testing of the lots? If so, what did the data
show, and did it confirm Chiron's weekly statements that the re-testing
indicated that they would be able to ship approximately 46 million
doses in October?
Answer 10. On August 25, 2004, FDA investigators were on site
conducting a prelicense inspection and were informed of the
contamination of the vaccine. FDA inspectors met with Chiron's staff
and reviewed the preliminary findings and the approach that Chiron was
taking to its investigation and retesting at multiple points in its
process. FDA investigators in Liverpool faxed to CBER preliminary data
and information regarding the scope and plans for the sterility failure
investigation being conducted by Chiron. The results of these
evaluations were needed and essential for any regulatory assessment.
Chiron's investigation was in the earliest stage and, therefore, only
preliminary information was available; however at the time the
additional testing on other lots were negative. Chiron did believe it
had identified the root cause for the contamination and that it was
limited to the affected lots. FDA performed a comprehensive review of
the retesting data during its October 10-15, 2004, inspection of the
Liverpool facility. The retesting results were indeed negative;
however, FDA's inspection found issues related to the adequacy of the
statistical sampling plan used for the retesting. These findings,
coupled with the other issues uncovered during the inspection, led FDA
to conclude that it could not assure the safety of the vaccine.
Question 11. Were FDA officials aware of the Medicines and
Healthcare Products Regulatory Agency's findings from their inspection
of Chiron's plant in March 2004? If so, what actions did the FDA take
to follow up on the British agency's concerns and ensure that Chiron
improved their manufacturing conditions?
Answer 11. FDA was not aware of MHRA's March 2004, inspection at
the time of the inspection. FDA recognizes the need to further
strengthen mechanisms for real-time communication with our foreign
regulatory counterparts. We are in the process of evaluating and
expanding agreements so that this type of information so that
government agencies can readily share such information in the future.
Food and Drug Administration
Question 12. The FDA has a special public trust to see that the
medicines that American patients take are safe and effective. I am
concerned that the Administration has not given the dedicated
professionals at FDA the support and leadership they need to do the
essential job that Americans count on them to do.
FDA must have the authority to require--not just to request--that
drug companies complete post-approval studies to assure that drugs put
on the market are safe and effective over the long haul for their
actually conditions of use. And it's clear that the passive monitoring
system that FDA now realizes on to monitor the safety of drugs after
they are approved isn't good enough.
Will you work to give FDA the leadership, resources, and authority
it needs to do its job? Will you work to see that FDA has the authority
to and resources it needs for post-market studies and surveillance, and
will you nominate a strong Commissioner who is free of ties to
industry? What other measures will you propose to help FDA enhance drug
safety?
Answer 12. I recognize that FDA has a special public trust to see
that the medicines Americans take are safe and effective. I am
committed to working with FDA to fulfill its mission to protect the
public health by assuring the safety, efficacy, and security of human
drugs; helping to speed innovations that make medicines more effective,
safer, and more affordable; and helping the public get the accurate,
science-based information they need to use medicines and to improve
their health.
Nominating an FDA Commissioner committed to the Agency's mission
will be one of my top priorities.
On November 5, 2004, FDA announced a five-step plan to strengthen
its drug safety program. Key among these steps is IOM study on FDA's
drug safety system, with an emphasis on the drugs as they are actually
used. These are important and ambitious steps designed to enhance drug
safety. I will work to see that FDA proceeds with this five step plan
and will consider additional steps that may further enhance drug
safety.
Question 13. American pay 60 percent more for prescription drugs
that the British or Swiss, two-thirds more than Canadians, 75 percent
more than Germans, and more than twice as much as Italians. This is
often for FDA approved drugs made by American companies in FDA approved
plants. Do you think this is fair? What will you do about it?
Answer 13. In recent years the Administration has worked to make
prescription drugs more affordable for U.S. consumers. FDA has taken
steps to encourage greater generic competition and speed access to
generic drugs as well as streamline the drug development and approval
process. As Secretary of HHS, I will work with Congress to continue to
address the high costs of health care.
Question 14. Secretary Tommy Thompson recently stated: ``I, for the
life of me, cannot understand why the terrorists have not attacked our
food supply, because it is so easy to do.'' Do you share Secretary
Thompson's concerns, and if so, how do you propose addressing the
problem?
Answer 14. I certainly share Secretary Thompson's concerns about
the safety of the food supply. Ensuring the safety of the food supply
has been a priority for Secretary Thompson, for the Administration and
will be a priority for me. I do know that a great deal has been done in
the past few years to improve security. For example, in 2002, the
President signed the Public Health Security and Bioterrorism
Preparedness and Response (Bioterrorism Act). This landmark legislation
represents the most fundamental enhancement to FDA's food safety
authorities in many years. FDA has been working hard to implement this
important legislation. In addition to implementing the Bioterrorism
Act, FDA has many other ongoing counterterrorism activities. However,
we must continue to be vigilant in these efforts. Ensuring the full and
effective continued implementation of the food safety regulations will
be a continued priority of mine and of HHS.
Question 15. Do you believe that Congress should require
manufacturers of dietary supplements to report serious adverse events
related to use of their products to the Food and Drug Administration?
Do you believe there are other steps FDA or the Congress should take to
better enable the agency to remove unsafe dietary supplements from the
market?
Answer 15. If confirmed as Secretary, I will carefully evaluate the
need for any additional authority relating to this issue.
As you may know, FDA recently published a new strategy to
strengthen its regulation of dietary supplements. FDA's strategy for
dietary supplements outlines the steps it plans to take to continue
implementing and enforcing the Dietary Supplement Health and Education
Act of 1994 (DSHEA). The strategy sets forth a series of research and
measures, including guidance, regulations, and science-based compliance
and enforcement mechanisms.
The strategy focuses on three areas: monitoring and evaluating
product and ingredient safety, ensuring product quality, and monitoring
and evaluating product labeling. With this strategy, FDA hopes to
improve the transparency, predictability, and consistency of the
Agency's scientific evaluations of dietary supplement product and
ingredient safety. The actions outlined in the strategy are also
designed to protect consumers against unsafe dietary supplements and
dietary supplements making unauthorized, false, or misleading claims.
FDA expects that this improved transparency will help engage
stakeholders in the development of further measures to implement DSHEA.
Question 16. Medically valuable antibiotics are often used
indiscriminately in animal agriculture to promote growth rather than to
treat disease. This misuse gives rise to drug-resistant pathogens that
can cause illness in people through contaminated food. FDA has taken
some important steps to scrutinize the public health impact of this
misuse of antibiotics by issuing guidelines for the evaluation of new
antibiotics proposed to be used as feed additives. These guidelines,
however, fail to address the public health concerns raised by
antibiotics already on the market as feed additives. hat do you plan to
do to protect the public from the danger of drug-resistant bacteria
that result from the misuse of antibiotics in animal agriculture?
Answer 16. FDA is concerned about antimicrobial resistance and the
use of antimicrobial drugs in food-producing animals. FDA agrees with
the Government Accountability Office's recommendation that it is
important to review animal drugs that are critical to human health and
to collect antibiotic use data.
Guidance for Industry #152, ``Evaluating the Safety of
Antimicrobial New Drugs with Regard to their Microbiological Effects on
Bacteria of Human Health Concern,'' addresses the pre-approval safety
assessment for new antimicrobial drugs intended for use in food-
producing animals. This guidance also is used for re-evaluating
currently approved veterinary antimicrobial drugs. FDA's Center for
Veterinary Medicine (CVM) has finished the assessment for the growth-
promoting uses of penicillin-containing antimicrobial drugs. CVM is
currently in the process of re-assessing the growth-promotion uses of
tetracycline-containing antimicrobial drugs.
In addition, CVM has re-evaluated the use of virginiamycin, a
streptogramins used in five species of food-producing animals, for its
potential to cause Synercid-resistant Enterococcus faecium in humans.
FDA has posted the draft risk assessment on its CVM website. In
addition, FDA published an announcement in the Federal Register on
November 23, 2004, that the risk assessment was available and that FDA
would accept comments for 60 days. FDA subsequently extended the
comment period an additional 30 days to February 23, 2005. The draft
risk assessment is available at: http://www.fda.gov/cvm/antimicrobial/
SREF--RA--FinalDraft.pdf.
My understanding is that FDA can pursue a number of regulatory and
administrative enforcement options if its reviews uncover a human
health risk. Any new antimicrobial drugs with animal feed claims will
be subject to review under the above-referenced guidance as well as
review by FDA's Veterinary Medicine Advisory Committee.
Occupational Health
Question 17. The National Institute for Occupational Safety and
Health in the Centers for Disease Control plays a pivotal role in
protecting our Nation's workers and thus in safeguarding our Nation's
public health. Last year's Omnibus Appropriations conference report
concurred in Senate language directing that NIOSH's role must not be
impeded or diminished through the CDC reorganization process.
As Secretary, what will you do to ensure, in keeping with Congress'
direction, that (1) no funds or personnel are transferred from NIOSH to
other parts of CDC, (2) NIOSH's current procedures and structure are
preserved; and (3) the Director of NIOSH continues to report directly
to the Director of CDC? Will you commit to these actions to ensure that
occupational safety and health remains a top agency priority?
Answer 17. CDC will make no changes to NIOSH's current operating
procedures or organizational structure and will ensure that no funds or
personnel will be transferred from NIOSH. The NIOSH Director will
continue to report directly to the Director of CDC and the NIOSH
Headquarters Office will remain in Washington, D.C. In addition, the
NIOSH Director will continue to have direct access to the Department of
Labor, the Occupational Safety and Health Administration, and the Mine
Safety and Health Administration as authorized by Congress. CDC is
committed to supporting NIOSH's success and its impact on preventing
work-related injuries, illnesses, and deaths.
Welfare/Community Services Block Grant
Question 18. Utah's program has been praised for its emphasis on
education and training. I understand recipients can participate in such
programs for up to 24 months to improve their chances of not just
finding immediate work, but building a career.
As Secretary will you continue to support an emphasis on education
and training in welfare reform? Will you support similar flexibility
for recipients to participate in education and training programs for up
to 24 months?
Answer 18. I support flexibility for States to tailor activities to
the needs of individuals while continuing to maintain the emphasis on
work that has been the cornerstone of the success of welfare reform. In
Utah, we designed our program to constantly emphasize the importance of
work as the best path toward self-sufficiency. Our TANF program, known
as the Family Employment Program, was one of the first in the Nation to
be integrated into the workforce development system.
The Administration's proposal for welfare reform emphasizes
increased flexibility for short-term education and training while
maintaining a strong emphasis on work. This approach is consistent with
research findings that show that intensive activities with a focus on
work produce the best result. Longer term education and training can be
counted toward the work requirement when they are performed in
conjunction with work.
Question 19. In addition, as you know, the Federal welfare reform
law imposed harsh restrictions on public benefits for legal immigrants.
Over 20 States now use State funds to replace the missing Federal
benefits for such immigrants.
As Chairman of the National Governor's Association you were
involved in urging the Federal Government to show more flexibility on
this issue. Would you support including more flexibility for States to
use Federal funds to provide social and medical services to legal
immigrants?
Answer 19. As you will recall, a number of the restrictions on non-
citizen eligibility have been eased over the years since the passage of
the 1996 law, particularly in the area of food stamps. In 2002,
President Bush proposed changes in the Food Stamp program that were
incorporated in the Farm Bill of 2002 (PL 107-171). The 2002 bill
expanded food stamp eligibility to legal immigrants who had resided in
the United States for five years or more, bringing the eligibility
provisions of the food stamp program more in line with TANF and
Medicaid. It also provided that children or disabled immigrants are
immediately eligible for food stamps, without a five-year waiting
period.
Under current law, States have the flexibility to provide federally
funded benefits for many qualified non-citizens including refugees,
political asylees, and, after five years, legal permanent residents.
Others can be served with State funds, and these expenditures may count
toward the TANF Maintenance of Effort requirement. I think these
provisions provide considerable flexibility to States while maintaining
the basic principle that regular immigrants should not enter the United
States expecting to receive welfare benefits, and that the individuals
who sponsor immigrants to enter the country should be held responsible
for meeting their basic needs, if necessary.
Question 20. You have described the 1996 Welfare Reform as a
``dramatic American success story.'' I agree that many Americans have
left the welfare rolls successfully, and they deserve great credit for
the independence and self-sufficiency they've achieved. But there
remains a need to improve upon current law, particularly to address the
recent increase in poverty as welfare caseloads continue to shrink. The
Administration says the decline is a good sign, but it seems that
welfare recipients are being dropped from the rolls, even though they
can't find a job. The Administration's welfare proposal would further
restrict the ability of States to address the variety of needs of
welfare recipients, and lead to more recipients being forced off of
welfare despite their need for work supports and other assistance.
Many of the successful aspects of Utah's welfare program that you
helped implement, such as increased support for education and training,
flexibility in dealing with barriers to work, and a wide variety of
countable work activities, differ from the provisions supported by the
Administration's welfare proposal. Will you commit to working with
Congress to address these issues in the Administration's welfare
proposal, ensuring that States like Utah have the flexibility they need
to help welfare recipients lift out of poverty, and to address the
individual needs of each family without being penalized by the Federal
Government?
Answer 20. I agree that State flexibility is a key to the past and
future success of welfare reform. TANF continues to be one of the best
examples of the power of State innovation and flexibility. In creating
the Temporary Assistance for Needy Families (TANF) program, Congress
acknowledged the immense capacity of States and localities to design
and conduct effective social programs, and incorporated the lessons
learned from State waivers into the TANF program. Utah, and many other
States, used this flexibility to design programs that respond to
individual needs, providing whatever services are needed to help
families put their lives back together and achieve self-sufficiency.
The Administration's welfare reauthorization plan gives States
increased flexibility to count certain activities as meeting the work
requirement for limited periods of time. States could receive credit
for families engaged in short term substance abuse treatment,
rehabilitation and work-related training designed to maximize self-
sufficiency through work. Such activities could also count for longer
periods when combined with work. The proposal also would allow States
to spend TANF funds carried over from previous years on any benefit,
service or other allowable TANF activity. This change, which would
greatly increase State flexibility, is based on the recognition that
cash benefits represent only one part of the services funded by TANF.
I look forward to working with the Congress to achieve the goals of
flexibility while retaining the results-oriented focus of the program
that is important to our success.
Question 21. I have seen the good work of the Community Services
Block Grant, or CSBG, in communities throughout Massachusetts.
Community Action Agencies use CSBG funds to coordinate and leverage the
resources of other programs to provide comprehensive services such as
Head Start, child care, energy assistance, employment and training,
food and nutrition services, literacy programs, and other low-income
programs. These agencies are on the front lines of service delivery for
the poor.
Congress is very supportive of the Community Services Block Grant
and the Community Action network. As you know, the Salt Lake Community
Action Program does good work for Utah's low-income families. I have
heard that the Administration's budget will not include funding for
CSBG. Will you pledge to work with Congress to revisit this decision?
Answer 21. I agree that there are good examples of work done by
Community Action Agencies using Community Service Block Grant funds, as
well as funds from other programs. I also think that accountability for
measurable results is something we must be concerned with in all
programs. I look forward to the opportunity to discuss with you issues
related to CSBG in the coming months as we work to improve key services
to low income families.
Mental Health
Question 22. In July of 2003, the final report of the President's
New Freedom Commission on Mental Health was released. It called for a
fundamental restructuring of how we care for families facing mental
illness, but Congress still hasn't acted. Mental illness is a crisis
for millions of children and adults and families who face it everyday.
It's a national crisis.
Can you commit to me to make this debate an HHS-wide priority, not
just a priority for the Substance Abuse and Mental Health Services
Administration within HHS, and when can we expect an Action Plan to
implement the reports recommendations?
Answer 22. The President's New Freedom Commission on Mental
Health's report, issued in July 2003, called for profound change and
transformation of the current system, recommending new service delivery
patterns and incentives to ensure that every American with mental
illness has easy access to the most current treatments and best support
services.
The Substance Abuse and Mental Health Services Administration
(SAMHSA) was tasked by the Department to review the Commission's report
and to lead the development of an Action Agenda for that transformation
to create a more recovery-focused mental health services delivery
system. An executive team at SAMHSA-along with senior staff from six
Federal departments and the Social Security Administration-are working
collaboratively to conduct a thorough review and assessment of the
Report. As expected, developing the Action Agenda has proven to be a
tremendous undertaking. The result, however, has been commitment for a
true Federal Action Agenda that is informed by the final report of the
New Freedom Commission and aligned with the President's priorities.
A hallmark of the Action Agenda is the unprecedented collaboration
and partnership across the Federal Government to work together and make
every effort to keep consumers and families at the center of care.
Question 23. Would you consider establishing an Inter-Agency
Council much like the Inter-Agency Council on Homelessness to
coordinate Federal programs that care and treat people with mental
illness?
Answer 23. In response to the President's New Freedom Commission on
Mental Health Report entitled ``Achieving the Promise: Transforming
Mental Health Care in America,'' the Substance Abuse and Mental Health
Services Administration (SAMHSA) convened representatives from 15
different Federal agencies to develop an Action Agenda Federal plan on
how to achieve mental health systems transformation. This Action Agenda
is being reviewed by those agencies and should be released shortly.
Contributing to the Agenda in addition to SAMHSA were the National
Institutes of Health, the Health Resources and Services Administration,
the Centers for Disease Control and Prevention, the Administration on
Aging, the Administration on Children and Families, the Centers for
Medicaid and Medicare Services, the Indian Health Service, the Social
Security Administration, the Department of Housing and Urban
Development, the Department of Education, the Department of Justice,
the Department of Transportation, The Department of Labor, and the
Department of Veterans Affairs. These agencies will continue to provide
continuing input and participate in our efforts to transform the mental
health delivery system.
The Action Agenda, besides making recommendations for change, is
itself an example at the Federal level of better coordination and
cooperation among programs and agencies serving those with mental
illness. It serves as an example to States and local governments on how
to improve the delivery of quality services to those among us who need
help in finding and living a life in the community, a life of recovery.
______
Response to Questions of Senator Mikulski
Question 1. Over six million poor senior Americans and 71,000
senior citizens in Maryland currently receive their prescription drugs
though the Medicaid program. When the new Medicare program begins in
2006, Medicaid will no longer be allowed to provide any drug coverage
for these Medicare beneficiaries.
Since you just referred to the new Medicare prescription drug law
as the ``main event of 2005,'' how would you ensure that no low-income
Medicare beneficiary loses drug benefits next year as a result of the
implementation of the Medicare law?
Answer 1. Starting on January 1, 2006, full-benefit dual eligible
and other low-income individuals will be provided drug coverage at
little or no cost through the new Medicare drug benefit. Approximately
six million full-benefit dual eligible individuals will automatically
qualify for subsidies of premiums and cost-sharing amounts under the
Medicare prescription drug benefit. I agree that it is critical that we
work to ensure as smooth a transition as possible for the dual eligible
population. As Secretary, this will be a priority of mine, and I hope
to work with you as we move forward in these efforts.
Question 2. Right now, if someone needs long-term care they must
work their way through a fragmented, patchwork array of programs to
piece together their long-term care needs. Given your experience as
Governor of Utah and managing many of the elements of this system, what
is your vision for a comprehensive national approach for strengthening
America's long-term care system?
Answer 2. Planning and paying for long-term care--and ensuring that
services are high quality--are among the biggest challenges America
will face as the population continues to age. Indeed, the array of
Federal, State and local programs, faith based services, self-funded
care, and long-term care insurance, combined with informal care by
family members and friends can be difficult to maneuver. We should
focus long-term care on the individual; people should be aware of the
need to plan for their long-term care needs, increase their savings,
purchase long-term care insurance, and take other steps to be prepared.
For some people this may not be possible and Medicaid will remain a
critical part of the system. Here too individuals should have more
control, building on the experience of Cash and Counseling. Medicaid
options that support consumer direction, such as Cash and Counseling,
are promising and represent a win-win for consumers, their personal
assistance workers, and States. On the awareness side, I look forward
to the results of the Department's new long-term care awareness
campaign and hope we can use those results to pursue additional
activities to help individuals plan for their own independence as they
age.
______
Response to Questions of Senator Murray
Medicare
Question 1. As you point out in your prepared statement,
implementation of the Medicare prescription drug legislation will be
immense and very challenging. I believe we have an obligation to assist
our seniors and disabled in making very difficult and complex decisions
in choosing a new MA plan or Drug Only Plan. It would be easy for those
of us who opposed final passage to simply refer confused and concerned
seniors, the disabled and their families to CMS. But, I do not think
this is helpful for anyone and would ask for your commitment to meeting
the challenges of outreach and education. I would also be interested in
your plans for moving forward with implementation. What resources would
be available? How can we work in a bipartisan fashion to educate and
help our seniors and disabled make informed decisions?
Answer 1. CMS will work with a broad array of partners, including
SSA and other federal agencies, States, employers and unions, and
national and community-based organizations to educate people with
Medicare, their caregivers and other who help them about the new
Medicare prescription drug benefit and other new Medicare benefits and
options. Importantly, CMS will conduct an integrated education campaign
and will reach out at the grass roots level to help people with
Medicare understand their options to access Medicare prescription drug
coverage. CMS is investing more than $300 million in this integrated
and multi pronged education effort including simple language fact
sheets, more detailed publications including the annual ``Medicare &
You'' handbook, direct mail, community based grassroots efforts to
target the different populations with messages directed to their
specific needs, e.g., low income, people with retiree drug coverage, 1-
800-MEDICARE, www.medicare.gov.
In the fall of 2005, the ``Medicare & You 2006'' handbook will
outline the specifics of Medicare prescription drug plans and list the
Medicare prescription drug plans available in each beneficiary's area
and people with Medicare will be able to get customized local Medicare
plan information, including cost, pharmacy, and formulary information,
at www.medicare.gov on the web, or by calling 1-800-MEDICARE.
Question 2. As you are aware, in the MMA legislation in 2003 we
took great strides to close the inequity in Medicare reimbursement
between rural and urban providers. This $25 billion investment will
reduce these inequities and provide relief to many rural providers.
However, Washington State remains at the bottom of per beneficiary
reimbursement for Medicare which puts our providers at an economic
disadvantage. Doctors and hospitals in Washington State receive far
less from Medicare because they are more efficient and have
significantly lower utilization rates. I believe we should provide
incentives to encourage more efficient use of care and begin to base
reimbursement on performance. I would be interested in knowing of your
plans for providing greater regional equity in Medicare and would like
to work with you to implement real reforms that reward performance as
opposed to over-utilization.
Answer 2. I certainly appreciate and understand the unique
challenges faced by rural providers. This Administration has made a
strong commitment to rural health issues and has implemented many
significant regulatory and Departmental reforms to promote rural health
care providers. Also, as you mention, the MMA included several
provisions to enhance beneficiary access to quality health care
services and improve payments in rural areas. As Secretary, I will
ensure that rural health care issues remain a top priority and continue
to receive the attention they deserve.
Encouraging improved health care quality is a top priority of mine
and of the President's. The Administration has promoted accountability
for quality, creating incentives to collect data from Medicare
providers on quality measures. I am intrigued by the possibility of
approaches to link Medicare reimbursement to provider performance.
While I certainly am not versed in the variety of ways that pay-for-
performance could be incorporated into the Medicare and Medicaid
payment systems, I am excited to be involved in conversations regarding
the issue. If I were to be confirmed, I would expect the Department
would continue to review this issue and I would want us to work with
the provider and beneficiary communities and the Congress in doing so.
Title X Family Planning
Question 3. As Governor of Utah you made statements and took
actions to reduce access to safe and effective family planning services
for all women, including minors. We know the cost of unintended
pregnancy, especially for teenagers. We know the importance of
comprehensive family planning that offers health care services and
access to safe and effective family planning. Unintended pregnancy is a
public health issue that needs to be addressed with sound, public
health strategies. Title X providers offer low income women access to a
whole range of reproductive health care services beyond simply
contraception. As the Secretary of HHS, will you support Title X
funding that provides the greater access possible to effective family
planning services? Are you aware of the importance of Title X in
meeting the reproductive health care needs of millions of low income
women?
Answer 3. Helping women to prevent unwelcome pregnancies is indeed
a public health concern, particularly when we are talking about our
young people. I am aware of the role that Title X has played in
providing family planning services to low-income women. As Secretary, I
will ensure that all of our programs, including Title X, are sensitive
and responsive to the needs of low-income Americans and that we
carefully assess concerns about access to care.
HEAD START
Question 4. President Bush has included in past budgets funding for
a block grant pilot program to States. However, funding of Head Start
has not kept up with the rising costs in Head Start while the funding
dedicated to a block grant could provide funding for services for
thousands of children. In such tight budget years, how can you justify
siphoning funding for a demonstration program that is unproven?
Head Start is one of the few Federal programs where funding goes
directly to locals. By block granting funding at the State level, you
would be adding bureaucracy to a highly successful program. What is the
Administration's intention in adding in this extra level of bureaucracy
to the program?
Answer 4. I share your interest in the Head Start program and the
contribution it has made to American's poorest children and families
for almost 40 years. Nevertheless, research continues to indicate that
too many children are leaving Head Start without certain key skills
needed for success in early schooling. One way to address this issue is
to strengthen Head Start's coordination efforts with local schools and
other pre-school programs.
However, I can assure that the President's reauthorization
proposal, which would allow States the option of administering Head
Start and making changes to improve child outcomes and better
coordinate services, is quite different from a block grant. States will
have to follow very specific procedures in applying. There will be
continuing Federal oversight of the State's delivery of Head Start
services. Moreover, States will be required to continue to serve at
least as many Head Start eligible children as are currently served
while maintaining the comprehensive nature of Head Start.
I am committed to ensuring that implementation of the President's
proposal will provide an opportunity for more children to be served by
local Head Start programs at the highest level of quality.
Washington State 1915(b) Waiver Services for People With Mental
Illnesses
Medicaid Capitation Savings Question
Question 5. Mr. Leavitt, as I understand the situation, the
department is prohibiting the State of Washington from using its
Medicaid savings to finance community-based and inpatient psychiatric
hospital services for adults with severe and persistent mental
illnesses.
Specifically, CMS used negotiations over a 1915(b) waiver renewal
to bar the State from using Medicaid capitation savings--achieved by
Washington's quasi-governmental regional managed care entities--to pay
for community-based and inpatient care for extremely vulnerable people.
This was a disturbing development because the State for more than a
decade had reasonably relied upon the agency's previous position, which
permitted such payments. CMS's new stance caused the loss of $80 to
$100 million in combined Federal and State spending, and threatened
mental health care for 127,000 Washingtonians. CMS has allowed the
State a 14-month extension in which to realign its system and funding
mechanisms with the new CMS policy and, for that, the State is
extremely appreciative.
However, since the prohibition does not apply to savings generated
by for-profit managed care companies, I find the CMS position to be
bewildering. Can you please explain the rationale behind this policy?
And can you tell me how CMS's recently announced position is consistent
with President Bush's public commitment to give States more flexibility
over the Medicaid program?
Answer 5. Medicaid statute and regulations do not restrict a
managed care organization's use of capitated payments as long as the
health care of Medicaid enrollees, per the managed care contract, is
met. However, CMS is working with Washington and other States to assure
that rate setting data, based on previous Medicaid services, is
consistent with Medicaid statute and regulations. These provisions,
which apply equally to both public and private entities, require that
program contract rates be developed based on Medicaid services to
Medicaid eligibles only (per 42 CFR 438.6). This means that rates must
be developed exclusive of non-approvable expenditures such as funds
expended for persons in an Institution for Mental Disease (IMD) (per 42
CFR 435.1008). During CMS review of Washington State's waiver renewal
application, the cost for non-Medicaid eligibles and non-state plan
services were included in the State's calculations for determining
future rates for this program, which is not permissible under Federal
law.
The Balanced Budget Act of 1997 included very specific provisions
concerning contract requirements to assure appropriate levels of
payment to Medicaid managed care entities. In response, CMS implemented
the Medicaid Managed Care Rule, which includes contract requirements
that prevent the CMS from approving contracts in which Medicaid rates
include non-state plan services and services to non-Medicaid
beneficiaries. These provisions, which changed how States previously
calculated their program's cost effectiveness, ensure the fiscal
integrity of the Medicaid program. States were required to be in
compliance with these regulations by August 13, 2003.
As Secretary, I assure you that the Department will work with the
State of Washington to provide the most flexibility possible within the
Medicaid program, while meeting all statutory and regulatory
requirements.
Institution for Mental Diseases (IMD) Exclusion
Question 6. Current CMS policy prohibits Medicaid reimbursement for
adults with serious mental illnesses served in inpatient psychiatric
hospitals, which are known in Medicaid parlance as ``Institutions for
Mental Diseases'' or IMDs. The prohibition specifically applies to
facilities with sixteen (16) or more beds.
In Washington, the rule complicates the ability of the State to
move people out of public hospitals and into community-based
residential services. Apparently, the IMD rule specifically applies to
non-hospital, residential facilities which are essential to the web of
services necessary to sustain adults with severe and persistent mental
illnesses in the community.
Upon your confirmation as Secretary of DHHS, will you look into
this outdated regulation with an eye toward at least raising the
sixteen (16) bed limit, or alternatively exempting residential
facilities from the IMD exclusion?
Answer 6. Since the IMD exclusion is rooted in legislation, not
regulation, congressional action is needed to change this provision.
However, I understand that CMS has been working with States and
providers to develop community-based alternatives and find ways to make
the current mental health system to operate more effectively.
______
Response to Questions of Senator Reed
Question 1. Many health experts, including infectious diseases
physicians, predict that the next influenza pandemic is imminent.
During the past century, pandemics of influenza occurred in 1918, 1957,
and 1968, with significant morbidity and mortality in both high risk
and normal children and adults. In 1918 alone, more than 500,000 people
died in the United States, and 20 million to 50 million people may have
died worldwide. It is estimated that the next influenza pandemic could
cause an average of up to 200,000 deaths in the United States alone.
The recent influenza vaccine shortage has demonstrated that our Nation
is not adequately prepared to deal with the next flu pandemic.
Challenges such as a limited influenza vaccine market, too few
dedicated manufacturers, a lack of adequate coordination among Federal
agencies, and the absence of an international influenza research agenda
compound the list of inadequacies our Nation is facing. Influenza
represents a global danger that cannot be underestimated, and I hope
you will consider it a public health priority. If confirmed, how do you
plan to address these challenges?
Answer 1. Preparation for the annual flu season has been a priority
at HHS. I will ensure that it continues to be a priority. I believe
that the CDC and FDA have successfully taken great strides toward
responding to an unforeseeable shortage of vaccine, through the
creation of tools to help States identify additional vaccine, through
the identification and purchase of additional vaccine under an
investigational new drug (IND) application, and through effective
public communication about the prioritization of high-risk groups who
should receive the available vaccine.
I will also ensure that efforts to prepare against a possible
influenza pandemic continue to be a priority, including through the
continued review and finalization of the national pandemic response
plan, as well as through the utilization of the $100 million recently
allocated to these efforts in the Omnibus appropriations bill.
Looking forward to the future, we will continue to work with
vaccine manufacturers to encourage them to bring their vaccine for
licensure and sale in the United States, as well as taking longer-range
steps to encourage the development of a domestic vaccine supply, to
ensure appropriate supplies of influenza vaccine. I look forward to
working with the committee on this issue--any steps that we take should
be careful to remove disincentives that may have hindered manufacturers
from entering or remaining in the U.S. vaccine market.
Question 2. The National Bone Marrow Donor Registry (Registry)
operated by the National Marrow Donor Program (NMDP) is a critically
important national resource. As an original sponsor of the legislation
authorizing the National Bone Marrow Donor Registry, the continuation
of this national resource remains a top priority to me. We created this
program to provide patients and their doctors with a single point of
access to locate volunteer, unrelated marrow donors. However, I am
extremely concerned that the authorization for this highly successful
program has been allowed to expire. What additional support can the
Department provide to ensure the continuation of this model Federal
program?
Answer 2. Bone marrow transplants offer the possibility of a cure
for many people suffering from blood and genetic diseases, such as
leukemia. The National Bone Marrow Donor Registry is an important
program that helps transplant candidates, who cannot locate a donor
related to them, to search for a suitable unrelated donor. The Registry
is the largest system connecting patients and physicians with volunteer
donors. And this year, the Registry received a good assessment from
OMB. Thank you for your support for this successful program. If I am
confirmed as Secretary, I will stand ready to work with you to ensure
the continuation of this program.
Question 3. I have recently heard from a number of my constituents
who are concerned about tobacco companies marketing flavored tobacco
products that could be attractive to children. More generally, tobacco
companies are increasing their marketing and promotional expenditures.
According to the most recent data from the Federal Trade Commission,
the companies now spend $12.7 billion annually on marketing, an
increase of 84 percent since 1998. At the same time, the resources to
fund anti-smoking education efforts targeting children are
disappearing. For example, the Legacy Foundation, which is responsible
for the truth media campaign, has been funded through the tobacco
industry's Master Settlement Agreement with the States since 1998.
However, due to the terms of the settlement, nearly all of the industry
payments to the Legacy Foundation ended in 2003--a reduction in funding
of $300 million per year. If you are confirmed, what steps will you
take to protect our kids from tobacco marketing and prevent them from
smoking? Can you make a commitment that as Secretary of HHS you will do
everything in your power to support initiatives that science tells us
are essential to protect our kids?
Answer 3. Tobacco-related deaths are the leading preventable cause
of death and disease in the United States. Each year, smoking causes
about 440,000 premature deaths and costs the Nation $75 billion in
direct health care expenses. Our first priority should be to keep
tobacco products out of the hands of America's children and to
encourage all Americans not to smoke, including by helping them quit
smoking.
Last year, the President proposed $701 million for HHS activities
related to tobacco. I intend to continue plans announced recently by
Secretary Thompson to help Americans quit smoking. The initiatives
include the opening of a national quitline number (1-800-QUITNOW) that
puts users in touch with programs that can help them give up tobacco.
In addition, a new HHS Web site (www.smokefree.gov) offers online
advice and downloadable information to make cessation easier.
The Office on Smoking and Health (OSH) is the Nation's lead Federal
agency for tobacco use prevention efforts and plays a critical role in
the fight to reduce the health effects of tobacco use. OSH's program
efforts are directed toward achieving progress in the following goal
areas: preventing initiation of tobacco use among youth and young
adults; eliminating exposure to secondhand smoke; identifying and
eliminating tobacco-related disparities; and promoting tobacco use
cessation among adults and youth to promote a comprehensive approach
for tobacco use prevention and control. All OSH activities directly or
indirectly support these goal areas.
Question 4. In 1995, you stated your disapproval of the Federal
Government creating new areas of eligibility and benefits under
Medicaid. In fact, you stated that the average Medicaid recipient in
Utah had a benefit package 30 percent richer than the average working
person. Unfortunately, these are often very ill or disabled individuals
who require a disproportionate amount of care and are unable to pay
substantial out-of-pocket expenses such as deductibles and co-pays for
care. Cindy Mann, a research professor at the Health Policy Institute
of Georgetown University, was quoted in the New York Times as saying
that the coverage under the Utah waiver was ``well below any generally
accepted standard of what it means to be insured.'' Can you address
this assessment? Can you summarize the services that the Utah program
actually covered and what it excluded? As Secretary of HHS, how would
you define basic Medicaid benefits?
Answer 4. First and foremost, I believe strongly that waivers
provide States with the flexibility to implement innovative ways to
extend health coverage to more people. This is a goal we should all
support. The waiver that I implemented in Utah did not make any changes
to the benefit for mandatory populations. Instead, the waiver expanded
preventive and primary care coverage to an additional 25,000 uninsured
adults. To do so, a $50 enrollment fee was instituted, but with
exemptions for vulnerable optional populations (including the elderly,
blind, disabled, children and pregnant women).
Question 5. Do you support the President's Medicaid reform proposal
that would give States the option of getting a capped amount of money
for ``optional'' populations? As a former Governor and Medicaid work
group leader, you know the National Governors Association continues to
oppose such a step to shift the fundamental partnership between State
and Federal Governments. As Secretary of HHS, how would you work with
governors to maintain our commitment to low-income and medically needy
Americans who rely on Medicaid as their only option for health care?
Would you favor extending further flexibility to States without capping
federal matching funds? How would you justify removing Federal
beneficiary protections in exchange for this flexibility?
Answer 5. Reform itself should be designed to give States the tools
they need to bring Medicaid into the 21st century on a cost effective
basis. Medicaid remains under rules designed specifically for the
1960s. Its mission has changed and expanded but the rules have not.
People with disabilities especially want better choices than what
Medicaid currently offers them for long term care services. It is clear
when you talk to any governor or State legislator, regardless of
political affiliation, that they believe the rate of growth in Medicaid
is unsustainable.
I want to work with Congress and the Nation's Governors to examine
the Medicaid program and to change it to give States the tools to
provide basic health coverage to the most low-income people possible.
Question 6. As you know, there have been ongoing issues with regard
to the redistribution of unused SCHIP funds. This year, $1 billion in
unexpended funds actually reverted back to the Treasury. Rhode Island
is one of several States that exhausts its allocation of funds each
year and is deeply concerned about reallocated, unexpended funds. My
State was one of the first States to expand coverage to kids prior to
the creation of the SCHIP program. It is my understanding that the
Administration is interested in SCHIP reauthorization in the coming
years. In what ways do you think the program needs to be changed?
Answer 6. First, published in the Federal Register recently is the
notice for the redistribution of fiscal year 2002 SCHIP funds which
were unexpended at the end of fiscal year 2004. This has assured that
no State will experience a funding shortfall this fiscal year.
The Federal Register notice details the methodology used, as well
as the list of States that will receive redistributed funds. In the
notice the five States which would have had shortfalls (Arizona,
Minnesota, Mississippi, New Jersey and, most notably for you, Rhode
Island), will first receive sufficient funds to cover their shortfalls.
After these shortfall States are made whole, 28 States (including the 5
shortfall States) will receive redistributions. Rhode Island received
over $23 million from this redistribution.
I look forward to working with Congress to re-authorize SCHIP, to
assure stability in the program.
Question 7. As Secretary of HHS, you will be charged with
overseeing the administration's abstinence-only programs, which are
slated to receive an unprecedented $168 million in Federal taxpayer
funding this year. A recent report by the House Committee on Government
Reform revealed that many of the most common federally funded
abstinence-only curricula contain errors, distortions and stereotypes
while other recent reports have called into question the effectiveness
of abstinence-only programs. For example, in 2001 the National Campaign
to Prevent Teen Pregnancy found no credible studies of abstinence-only
programs showing any significant impact on participants? initiation or
frequency of sex. The National Academy of Sciences' Institute of
Medicine has criticized the investment of hundreds of millions of
dollars in unproven abstinence-only programs as ``poor fiscal and
public health policy.'' What steps will you take as secretary to
evaluate the accuracy and effectiveness of these programs and ensure
that science, not ideology, is driving administration policy?
Answer 7. I share the President view that . . .``Abstinence is the
surest way and the only completely effective way to prevent unwanted
pregnancies and sexually transmitted diseases.'' I also agree with the
President that we must promote public policies that are medically
accurate. I also am committed to continuing to support the rigorous
evaluation efforts currently underway in the Department.
Question 8. What were EPA's considerations in accepting $2 million
from the American Chemistry Council to help fund the Children's
Environmental Exposure Research Study? In light of recent challenges
faced by the FDA, how would you balance the collection of user fees by
FDA under the Prescription Drug User Fee Act (PDUFA) and FDA's
regulatory role in ensuring the safety of drugs seeking approval?
Answer 8. Because protecting the health and well-being of children
is of paramount importance, EPA has decided to send the Children's
Environmental Exposure Research Study (CHEERS) for another external,
independent review by an expert panel made up of members of the Science
Advisory Board, the Science Advisory Panel, and the Children's Health
Protection Advisory Committee. It is anticipated that this review will
be completed and that a report will be forwarded to the Administrator
in the spring of 2005. [Based on this review, the Agency will reassess
the study.]
EPA scientists need to fully understand how children are exposed to
pesticides and through what media (air, water, soil, etc.) EPA is
particularly concerned about childhood exposure, because children may
be more vulnerable than adults to the effects of environmental
contaminants due to their smaller body sizes and rapid physical
development. There is insufficient research to define pathways of
exposure--the routes by which pesticides may enter a child's body.
Possible pathways that could be investigated are ingestion (food and
drink), inhalation, residue from crops, soil and ingestion of household
dust.
CHEERS was designed to fill these critical data gaps in our
understanding of children's exposure to pesticides and chemicals in
household environments, ultimately leading to actions that would lower
children's exposures to pesticides. The study design was externally
reviewed for scientific merit and ethical protections by four
Institutional Review Boards (IRBs) for the Protection of Human
Subjects. The IRBs and the dates they approved the study are: Battelle
Memorial Institute (August 2004), University of North Carolina
(September 2004), Duval County (Florida) Health Department (conditional
approval) and University of Florida (May 2004).
If confirmed, I will work to ensure that FDA performs its important
statutory responsibility to monitor the safety of approved drugs. The
enhanced post-marketing surveillance provisions in the Prescription
Drug User Fee Act provide new tools and opportunities to accomplish
this goal.
[Whereupon, at 11:56 a.m., the committee was adjourned.]