[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]




 
                   HEARING ON STRATEGIES TO INCREASE
                       INFORMATION ON COMPARATIVE
                        CLINICAL EFFECTIVENESS

=======================================================================


                                HEARING

                               before the

                         SUBCOMMITTEE ON HEALTH

                                 of the

                      COMMITTEE ON WAYS AND MEANS
                     U.S. HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 12, 2007

                               __________

                           Serial No. 110-46

                               __________

         Printed for the use of the Committee on Ways and Means



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                      COMMITTEE ON WAYS AND MEANS

                 CHARLES B. RANGEL, New York, Chairman

FORTNEY PETE STARK, California       JIM MCCRERY, Louisiana
SANDER M. LEVIN, Michigan            WALLY HERGER, California
JIM MCDERMOTT, Washington            DAVE CAMP, Michigan
JOHN LEWIS, Georgia                  JIM RAMSTAD, Minnesota
RICHARD E. NEAL, Massachusetts       SAM JOHNSON, Texas
MICHAEL R. MCNULTY, New York         PHIL ENGLISH, Pennsylvania
JOHN S. TANNER, Tennessee            JERRY WELLER, Illinois
XAVIER BECERRA, California           KENNY HULSHOF, Missouri
LLOYD DOGGETT, Texas                 RON LEWIS, Kentucky
EARL POMEROY, North Dakota           KEVIN BRADY, Texas
STEPHANIE TUBBS JONES, Ohio          THOMAS M. REYNOLDS, New York
MIKE THOMPSON, California            PAUL RYAN, Wisconsin
JOHN B. LARSON, Connecticut          ERIC CANTOR, Virginia
RAHM EMANUEL, Illinois               JOHN LINDER, Georgia
EARL BLUMENAUER, Oregon              DEVIN NUNES, California
RON KIND, Wisconsin                  PAT TIBERI, Ohio
BILL PASCRELL, JR., New Jersey       JON PORTER, Nevada
SHELLEY BERKLEY, Nevada
JOSEPH CROWLEY, New York
CHRIS VAN HOLLEN, Maryland
KENDRICK MEEK, Florida
ALLYSON Y. SCHWARTZ, Pennsylvania
ARTUR DAVIS, Alabama

             Janice Mays, Chief Counsel and Staff Director

                  Brett Loper, Minority Staff Director

                                 ______

                         SUBCOMMITTEE ON HEALTH

                FORTNEY PETE STARK, California, Chairman

LLOYD DOGGETT, Texas                 DAVE CAMP, Michigan
MIKE THOMPSON, California            SAM JOHNSON, Texas
RAHM EMANUEL, Illinois               JIM RAMSTAD, Minnesota
XAVIER BECERRA, California           PHIL ENGLISH, Pennsylvania
EARL POMEROY, North Dakota           KENNY HULSHOF, Missouri
STEPHANIE TUBBS JONES, Ohio
RON KIND, Wisconsin

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Ways and Means are also, published 
in electronic form. The printed hearing record remains the official 
version. Because electronic submissions are used to prepare both 
printed and electronic versions of the hearing record, the process of 
converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.


                            C O N T E N T S

                               __________

                                                                   Page

Advisory of June 12, 2007, announcing the hearing................     2

                               WITNESSES

The Honorable Thomas Allen, a Representative in Congress from the 
  State of Maine.................................................     6

                                 ______

Carolyn M. Clancy, M.D., Director, Agency for Healthcare Research 
  and Quality, Rockville, Maryland...............................    15
Peter R. Orszag, Ph.D., Director, Congressional Budget Office....    21
Mark Miller, Ph.D, Executive Director, Medicare Payment Advisory 
  Commission.....................................................    43

                                 ______

Gail Wilensky, Ph.D., Senior Fellow, Project Hope, Bethesda, 
  Maryland.......................................................    79
David Dale, M.D., President, American College of Physicians......    83
Gail Shearer, Director, Health Policy Analysis, Consumers Union..    89
Susan Hearn, Ph.D., Senior Project Manager in Environment Health 
  and Safety, Dow Chemical Co., Midland, Michigan................    95
Steve M. Teutsch, M.D., MPH, Executive Director, Outcomes 
  Research and Management, Office of Scientific and External 
  Affairs, Merck and Co.,Inc., West Point, Pennsylvania..........    98

                       SUBMISSIONS FOR THE RECORD

Advanced Medical Technology Association, statement...............   116
Coalition for Health Services Research, statement................   119
Epilepsy Foundation, Letter......................................   124
Mental Heath America, statement..................................   126
National Alliance on Mental Illness, Arlington, Virginia, 
  statement......................................................   130
Pharmaceutical Research and Manufactures of America, statement...   132
Society of General Internal Medicine, statement..................   134


                  HEARING ON MEDICARE PAYMENT ADVISORY
                   COMMISSION'S ANNUAL MARCH REPORT

                              ----------                              


                         TUESDAY, JUNE 12, 2007

             U.S. House of Representatives,
                       Committee on Ways and Means,
                                    Subcommittee on Health,
                                                    Washington, DC.

    The Subcommittee met, pursuant to notice, at 10:05 a.m., in 
Room 1102, Longworth House Office Building, The Honorable 
Fortney Pete Stark (Chairman of the Subcommittee) presiding.
    [The advisory announcing the hearing follows:]

ADVISORY

FROM THE 
COMMITTEE
 ON WAYS 
AND 
MEANS

                         SUBCOMMITTEE ON HEALTH

                                                CONTACT: (202) 225-3943
FOR IMMEDIATE RELEASE
June 12, 2007
HL-13

                      Stark Announces a Hearing on

                 Strategies to Increase Information on

                   Comparative Clinical Effectiveness

    House Ways and Means Health Subcommittee Chairman Pete Stark (D-CA) 
announced today that the Subcommittee on Health will hold a hearing on 
strategies to increase research and information on comparative clinical 
effectiveness. The hearing will take place at 10:00 a.m. on Tuesday, 
June 12, 2007, in room 1100, Longworth House Office Building.
      
    In view of the limited time available to hear witnesses, oral 
testimony at this hearing will be from the invited witness only. 
However, any individual or organization not scheduled for an oral 
appearance may submit a written statement for consideration by the 
Committee and for inclusion in the printed record of the hearing.
      

BACKGROUND:

      
    Rising health care costs and a lack of evidence justifying extreme 
variations in the provision of medical services have led many to call 
for a Federal effort to substantially increase information on the 
relative effectiveness of health care services. Health policy experts 
across the political spectrum advocate that such information is a 
sorely needed public good, and that greater investment in comparative 
effectiveness research is critical to assuring high-quality care and 
reducing unnecessary spending.
      
    Various authorities both within and outside government have called 
for national investment in comparative effectiveness information, and 
have identified issues and options to help Congress determine optimal 
financing and governance for this activity. Providing Medicare with 
better information about the relative strengths and weaknesses of 
various products, procedures and services will help public and private 
payers equitably and efficiently manage rising health care costs.
      
    On announcing this hearing, Chairman Stark said: ``As Medicare's 
steward, Congress needs to ensure that Medicare resources are being 
used effectively to provide high quality care and achieve the best 
possible patient outcomes. Getting reliable, unbiased comparative 
information is our best shot at reducing health spending while 
improving care and preserving access. This hearing will identify ways 
we can get the information we need to achieve this important goal.''
      

FOCUS OF THE HEARING:

      
    The hearing will review the benefits of comparative effectiveness 
research, and opportunities for the Federal Government to expand the 
availability and value of such research.
      

DETAILS FOR SUBMISSION OF WRITTEN COMMENTS:

      
    Please Note: Any person(s) and/or organization(s) wishing to submit 
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2007. Finally, please note that due to the change in House mail policy, 
the U.S. Capitol Police will refuse sealed-package deliveries to all 
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problems, please call (202) 225-1721.
      

FORMATTING REQUIREMENTS:

      
    The Committee relies on electronic submissions for printing the 
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not alter the content of your submission, but we reserve the right to 
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    1. All submissions and supplementary materials must be provided in 
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Committee relies on electronic submissions for printing the official 
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    2. Copies of whole documents submitted as exhibit material will not 
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    Note: All Committee advisories and news releases are available on 
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    The Committee seeks to make its facilities accessible to persons 
with disabilities. If you are in need of special accommodations, please 
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materials in alternative formats) may be directed to the Committee as 
noted above.

                                 

    Chairman STARK. The Subcommittee will begin. Today is 
another in our series of hearings on how to improve Medicare, 
and we'll focus on long-term solutions to increase and assure 
the value of health care expenditures. This we hope to deal 
with the issue of comparative clinical effectiveness. That 
means comparing the relative value of different clinical 
treatments, drugs, devices, tests, procedures, bandages, pills, 
anything else you want to take, and trying to get a comparative 
ranking.
    Too often, physicians and patients have trouble 
understanding when a new product or test or procedure will be 
most helpful and how to choose among existing courses of 
treatment. Given the absence of information on comparative 
effectiveness, it's hardly surprising that GAO and MedPAC find 
dramatic variation in the use of medical services across 
regions, from different providers, by different specialties. 
Even worse, researchers find that the areas with the highest 
use of some services aren't necessarily linked to higher 
quality or better outcomes. To the contrary, beneficiaries may 
be put at greater risk when they're subjected to more and more 
complicated tests and treatments.
    As Medicare's Board of Directors, Congress should ensure 
that Medicare resources are used effectively and efficiently to 
provide high-quality care and achieve the best possible 
outcomes. Getting reliable, unbiased comparative information is 
our best chance at controlling health care spending while 
improving care and access. Even if Mr. Orszag won't give us 
savings immediately for our efforts, we can identify ways that 
we can get the information we need to achieve this goal and lay 
the groundwork for a more efficient and effective system.
    Health policy experts across the political spectrum 
advocate that comparative information is sorely needed for the 
public good. They argue that greater investment in comparative 
effectiveness research is critical to assuring high-quality 
care and reducing unnecessary expenditures. Better information 
about the relative strengths and weaknesses of various 
products, procedures and services will help physicians and 
patients make wise decisions and will help public service and 
private payers equitably manage rising health care costs.
    Many countries have already made major investments to 
provide this information to physicians, patients, policymakers, 
and it's high time we do the same. Many of my colleagues urge 
that we should pay for performance. We already do that. The 
providers perform and we pay. It's just that we pay the same 
whether the service is done on the right people at the right 
time or the wrong people at the wrong time. We really have to 
know what the effective and appropriate services are before we 
can know how to reward the care that achieves the best 
outcomes.
    Various authorities both within and outside government have 
called for a substantial national investment in comparative 
effectiveness information and have identified issues and 
options to help us determine the optimal financing and 
governance for this activity. My personal preference is to move 
toward a system that's accountable yet independent and free 
from both industry and political influence. I want to repeat 
that. Free from both the industry and political influence. Both 
clinicians and patients need to be confident that the work that 
will be done is in the best interests of the patient. To me, 
that points to a government-led effort.We are fortunate to have 
with us today some of the leading experts as well as 
representatives of the prominent stakeholders. I am 
particularly pleased to welcome our first witness, but prior to 
that and prior to my introduction of him, I'd like to yield to 
Mr. Camp for any remarks he'd care to make.
    Mr. CAMP. Well, thank you, Chairman Stark. The U.S. health 
care system lacks the kinds of comparative information that 
would allow consumers to make informed health care choices and 
providers to prescribe the best course of care. While we have 
agencies like the FDA to determine if drugs and devices are 
safe, we have very little information that compares the actual 
effectiveness of drug devices and medical procedures. 
Frequently, physicians lack the information that would allow 
them to compare what treatments work best for particular types 
of patients. This type of data could help health care providers 
identify best practices, ultimately leading to improved 
clinical outcomes.
    Comparative effectiveness data will also be necessary if we 
are to ever more to a more consumer-focused model of delivering 
health care, where individuals are able to make more choices 
about the care they receive. This information also has the 
ability to help reduce expenditures under the major Federal 
health programs by helping to eliminate unnecessary procedures, 
leading to a significant savings for taxpayers.
    At the same time, we cannot allow comparative effectiveness 
to become another hurdle that slows patients' access to new 
therapies. The current health care bureaucracies, especially 
those in the Medicare and Medicaid programs, are often unable 
to keep up with the dynamic and changing nature of health care. 
Government agencies should not be required to use or to rely 
solely on comparative effectiveness data to set reimbursements 
or make coverage decisions.
    Comparative effectiveness can be a building block that 
leads to better health outcomes, but only if it's done in a 
transparent and timely way. This will require a process that 
encourages independent research, which also recognizes that not 
all therapeutic choices will be appropriate for all patients. 
Patient protections must be in place to make certain that 
unique patients are not harmed in the name of cost saving 
initiatives. Put simply, comparative effectiveness should be 
viewed as a tool to influence decisions. It should not, 
however, be used to limit patient access to the best course of 
treatment.
    I look forward to hearing the testimony of the witnesses 
today, and hope that we can work together on legislation that 
will provide providers and patients with the information that 
can improve the quality of their health care.
    Thank you, Mr. Chairman. I yield back the balance of my 
time.
    Chairman STARK. You're welcome. Mr. Camp, I'd like to 
associate myself with your remarks. I think our, at least my 
interest in this effort, is to get us the information. I don't 
want to predetermine how we would use that information, but 
right nowand I've said this often to other people. We just went 
through an allergy season that was one of the worst, my 
pediatrician tells us, in 14 years. But you saw six or eight or 
ten antihistamines in every popular magazine, but nobody really 
had good records of which one was the best to use for your 
kids.
    As I'd say to the people in the audience, when the men in 
the audience get prostate cancer, you won't know what is the 
best treatment. You'll know that you'll live through the 
initial treatment whether you do chemo or radiation or surgery. 
We just don't have figures that are reliable that will tell you 
what happens to you 10 years out. The same with the ladies in 
the audience who may unfortunately get breast cancer. You won't 
have the kinds of statistics we need for you to predict with 
your physician what's the best course for you to follow. I hope 
that whatever comes out of the work we do on this Committee 
will help providers, beneficiaries, the taxpayers and everybody 
to understand that better.
    To that end, I'm pleased to welcome our first witness, 
Congressman Tom Allen from Maine, who has been a leader in the 
House on the issue of comparative effectiveness and has 
recently submitted legislation to address this problem. The 
subsequent witnesses I'm sure will enlighten us on whatever 
their strategy is to improve health care in the United States, 
and I look forward to their testimony.
    Tom, would you like to enlighten us in any manner you'd 
care to? If you have a prepared statement, it will appear in 
the record in its entirety without objection.

   STATEMENT OF THE HONORABLE TOM ALLEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF MAINE

    Mr. ALLEN. Thank you, Mr. Chairman. Thank you for holding 
this hearing, and I want to thank you and Ranking Member Camp 
for inviting me to testify today. I would ask my entire 
statement to be submitted.
    Chairman STARK. Without objection.
    Mr. ALLEN. I will talk from that statement. We have a huge 
gap in our health care system today: the absence of 
independent, evidence-based information about the comparative 
effectiveness of prescription drugs, medical devices and other 
treatments that deal with the same illness or condition.
    Better information on how various treatments compare to one 
another will enable doctors and their patients to make informed 
decisions about whether new or high-priced drugs, devices and 
other medical treatments do or do not provide better clinical 
outcomes. The health care marketplace will be greatly enhanced 
by independent information more widely disseminated.
    We've seen remarkable innovations in health care in recent 
years, but the aggregate health care costs have grown 
considerably faster than the overall economy. The United States 
spends more than any other nation on health care, but we rank 
37th in the world in health outcomes. Nearly 47 million 
Americans are uninsured, and millions more are underinsured.
    On May 7th of this year, I introduced H.R. 2184, the 
Enhanced Health Care Value for All Act, with Representative Jo 
Ann Emerson, who has been with me on this issue for the 
lastwell, this is the third Congress. The bill extends the 
success of the Agency for Healthcare Research and Quality's 
Effective Health Care Program and provides more funding for on 
the comparative effectiveness of health care services, 
including prescription drugs, medical devices, procedures, and 
other treatments, and can include clinical trials as well as 
surveys of existing literature.
    Better clinical information on health care products and 
service is a public good. Therefore, the legislation creates a 
public-private funding mechanism to pool Federal resources with 
funds from health insurance plans and large employers with 
self-insured plans.
    The investment in comparative effectiveness studies 
provides a sound, bipartisan approach to a fundamental 
challenge: how to ensure that we get the best value for our 
health care dollar. This initiative has gained the support of a 
very broad group of stakeholders representing patients, medical 
professionals, health services researchers and health care 
purchasers.
    My bill expands on Section 1013 of the Medicare 
Prescription Drug Improvement and Modernization Act of 2003. 
That provision authorized AHRQ to carry out systematic reviews 
of existing research on the clinical comparative effectiveness 
and safety of prescription drugs and other treatments. Section 
1013 was based on legislation that Representative Emerson and I 
introduced in the 108th Congress, and H.R. 2184, our current 
bill, expands on the small initial investment in comparative 
effectiveness, $15 million appropriated by Congress in the last 
two fiscal years.
    Leaders at CMS, MedPAC, the Institute of Medicine and CBO 
have begun to explore this issue in greater detail. Economists 
Uwe Reinhardt, Stuart Altman and former CMS Administrator Gail 
Wilensky have put forth bold visions on where increased 
investment in comparative effectiveness could take us.
    To have the best medical outcome, patients need the right 
care at the right time. Without good information on comparative 
effectiveness, we can't be confident that we are using products 
in the optimal way. The FDA approval process, as Mr. Camp 
indicated, does not give us this data, because it tests only 
for safety and for effectiveness compared to a placebo, not 
effectiveness compared to other drugs or devicesother drugs in 
that casethat treat the same illness or condition.
    In closing, I want to make four critical points:
    Number one. More effective treatments mean better health 
outcomes and reduce side effects.
    Two. Overall comparative effectiveness data doesn't negate 
the need for individualized care. this is not, as some critics 
argue, a path to one-size-fits-all medicine.
    Three. Broadening comparative effectiveness studies will 
provide better information about differential impacts on 
subpopulations and the interaction of various treatments in 
patients with multiple illnesses. In other words, broader 
information will be very helpful.
    Fourth. High quality comparative effectiveness studies 
shouldn't threaten innovation. Instead, they will clarify the 
many reasons individuals can be exceptions to ``average'' 
outcomes and will facilitate transition to a system of 
affordable, personal health care.
    I thank you very much for having me here today and look 
forward to working with you on this legislation.
    [The prepared statement of Mr. Allen follows:]

           Prepared Statement of The Honorable Thomas Allen, 
          a Representative in Congress from the State of Maine

    Mr. Chairman and Ranking Member Camp, thank you for inviting me to 
testify today.
    We have a huge gap in our health care system: the absence of 
independent, evidence-based information about the comparative 
effectiveness of prescription drugs, medical devices, and other 
treatments that treat the same illness or condition.
    Having better information on how various treatments compare to one 
another will enable doctors and their patients to make informed 
decisions about whether new or high priced drugs, devices, and other 
medical treatments do or do not provide better clinical outcomes. The 
health care marketplace will be greatly enhanced by independent 
information more widely disseminated.
    We have seen remarkable innovations in health care in recent years. 
New discoveries in medicine, medical devices and treatments have 
improved the quality of life and extended the average life expectancy 
of Americans.
    Yet aggregate health care costs have grown considerably faster than 
the overall economy, contributing to double digit inflation for health 
care services. By 2016, U.S. health care spending is expected to almost 
double to $4.1 trillion and account for 20 percent of every dollar 
spent.
    The U.S. spends the most per capita of any nation on health care, 
yet it ranks behind most industrialized nations on major health 
outcomes. Nearly 47 million Americans are uninsured, and millions more 
are underinsured.
    On May 7, 2007 I introduced H.R. 2184, the Enhanced Health Care 
Value for All Act, with Representative Jo Ann Emerson. The bill builds 
on the success of the Agency for Health Care Research and Quality's 
``Effective Health Care Program'' and provides increased funding to 
finance new research on the comparative effectiveness of health care 
services (including prescription drugs, medical devices, procedures, 
and other treatments), which may include clinical trials.
    Recognizing that better clinical information on health care 
products and services is a public good, the legislation creates a 
public-private funding mechanism which will pool federal resources with 
funds from health insurance plans and large employers with self-insured 
plans.
    Investment in comparative effectiveness studies provides a sound, 
bipartisan approach to a fundamental challenge: how to ensure that we 
get the best value for our health care dollar. This initiative has 
gained the support of a broad group of stakeholders representing 
patients, medical professionals, health services researchers and health 
care purchasers.
    My bill expands on Section 1013 of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003. This provision provided 
authority for the Agency for Health Care Research and Quality to carry 
out systematic reviews of existing research on the clinical comparative 
effectiveness and safety of prescription drugs and other treatments. 
Sec. 1013 was based on legislation that Representative Emerson and I 
introduced in the 108th Congress (H.R. 2356) which gained broad 
bipartisan support.
    The Enhanced Health Care Value for All Act expands on the small 
initial investment in this research of $15 million appropriated by 
Congress in Fiscal Years 2005, 2006 and 2007.
    Leaders at the Centers for Medicare and Medicaid Services, Medicare 
Payment Advisory Commission, and Institute of Medicine have also begun 
to explore this issue in greater detail. Economists Uwe Reinhardt, 
Stuart Altman and former Health Care Financing Administration (now CMS) 
Administrator Gail Wilensky have put forth bold visions on where 
increased investment in comparative effectiveness could take us.
    There is widespread agreement that to have the best medical 
outcome, patients need the right care at the right time. If we don't 
have good information on comparative effectiveness we can't have strong 
confidence we are using products in the optimal way. The FDA approval 
process does not give us this data. For example, it approves drugs 
after testing for safety and effectiveness compared to a placebo, not 
for comparative effectiveness at treating a particular illness.
    In closing, I would like to make four critical points about 
comparative effectiveness studies:

        1.  More effective treatments mean better health outcomes and 
        reduced side effects.
        2.  Overall comparative effectiveness data doesn't negate the 
        need for individualized care. This is not, as some critics 
        argue, a path to ``one size fits all medicine.''
        3.  Broadening comparative effectiveness studies will provide 
        better information about differential impacts on sub-
        populations and the interaction of various treatments in 
        patients with multiple illnesses.
        4.  High quality comparative effectiveness studies shouldn't 
        threaten innovation; instead they will clarify the many reasons 
        individuals can be exceptions to ``average'' outcomes, and will 
        facilitate transition to a system of affordable, personalized 
        health care.

    Thank you for inviting me to testify today. I look forward to 
working with you to move toward a common goal: improving value in 
health care spending and ensuring that patients have access to the 
treatments that are right for them.

                                 

    Chairman STARK. Tom, thank you. If I understand your bill 
correctly, the question of who gets to plead their product or 
service at this court of effectiveness, that the entry key 
would be an FDA approval, for example.
    Mr. ALLEN. Yes.
    Chairman STARK. So, first you'd have to go through the 
process of proving that it was safe and as opposed, say, to a 
placebo, it did something.
    Mr. ALLEN. Right.
    Chairman STARK. That you just weren't bringing a placebo to 
the table.
    Mr. ALLEN. That's correct. I don't think it's right to slow 
down the process of getting approval at the FDA level, because 
I think that the AHRQ ought to be able to decide the 
appropriate time to conduct research on a particular group of 
drugs or a particular group of devices or treatments.
    Chairman STARK. Would the stakeholders haveor the 
manufacturers, the providers, the physicians, the 
pharmaceutical companies, whomeverwould they have input into 
selecting theor setting the agenda for this panel? In other 
words, there's certainly going to be more people lined up 
wanting an effectiveness test, then there will be a time lag. 
Howhave you given any thought to how that would be fairly 
determined?
    Mr. ALLEN. Well, what we've done is we create in this 
legislation, we expand the authority for the comparative 
effectiveness advisory board, and we want to make sure that the 
selection of the members of that board takes out people with 
financial interests in stakeholders, whether they be 
manufacturers of devices or manufacturers of prescription 
drugs.
    Then for each individual study, there is a clinical 
advisory panel. We want the same transparency, the same process 
there to make sure that the people with a financial interest in 
the outcome of the study are not choosing the people who will 
oversee it.
    Chairman STARK. So, to pick an example, MedPAC. Would that 
meet the standards that you have in mind? The way it's 
formulated and the panel is picked?
    Mr. ALLEN. Yes. We're looking for panels that have some 
degree of political oversight, because all of this run 
ultimately through the Secretary of Health and Human Services, 
but is as independent as possible and as transparent, and fully 
transparent, so that conflicts of financial interests are 
weeded out. So, you'll really have the independent, evidence-
based product at the end of the day that we need to do this 
research effectively.
    Chairman STARK. Now I hesitate to bring this up, but I know 
you're talking about buy in effect an all payer system, which 
makes sense. But can you give us a ballpark idea of what we're 
talking about in costs? I know you have it coming out ofthe 
money coming out of the trust fund. The question, could we use 
appropriated funds? I don't know. But what kind of agive me a, 
to the closest billion dollars or so what are we going to spend 
on this?
    Mr. ALLEN. Well, as I understand it, ultimately, that's up 
to this Committee and the Congress as a whole. But the 
legislation, we think the appropriate scale of investment os $3 
billion over 5 years, and that one-third of that, $1 billion, 
should be public money and should come from the Medicare trust 
fund, limited to a maximum of $200 million a year.
    The other we have support from the insurers and from large 
employers with self-insured plans, and they have bought into 
the concept of funding the other two-thirds. Because, remember, 
this information is going to be of great help to insurers and 
to large companies with self-insured plans. They're going to 
use it their own way. What we're simply trying to do is get 
good, evidence-based information out there for the public.
    Chairman STARK. So, what you're suggesting is that for the 
public, the beneficiaries at large, the public, the government 
should come up with that money out of revenues of one sort or 
another? The other two-thirds would be contributed by the 
providers and/or the manufacturers, people with a commercial 
interest at stake?
    Mr. ALLEN. Well, by the insurance plans and by large 
employers. We are not suggesting that the pharmaceutical 
industry contribute to that fund. We are saying those who use 
the information in their own way. This kind of research is 
being done now by individual insurance companies, but because 
that information is not widely shared, it's notit doesn't have 
the impact that it could.
    Chairman STARK. Thank you. Mr. Camp?
    Mr. CAMP. Well, thank you, Mr. Chairman. Mr. Allen, thank 
you for your testimony. Obviously, we often lament the fact 
that we don't have good enough data or information even for 
policy decisions, much less so that individuals and physicians 
can make the appropriate decisions on the kind of care, as the 
Chairman mentioned earlier in this hearing.
    But, obviously, I think there's a broad agreement that this 
kind of information, comparative effectiveness research, could 
help informed decision making in the health care area.
    But as you look at other nations that do this, and they're 
further along than we are, there's a concern that insurance 
companies, maybe even CMS in America, could use this 
information to limit access to certain treatments, because 
someone may not fit the ``average'' stereotype. I realize there 
could be subgroups that might sort of mitigate that. But does 
your legislation have any specific safeguards to assure that 
access to patient-centered treatments is still available?
    Mr. ALLEN. I would put it this way. The legislation is 
designed simply to deal with access to information and make 
that information available. We would obviously be open to 
suggestions along the lines that you are making here today. But 
the legislation itself is very clear. In your opening, you 
raised the concern about whether the information would inform 
decisions or drive decisions. It is not the intention of this 
legislation to drive decisions. But we're obviously open to 
suggestions to clarify the point that you're making today.
    Mr. CAMP. Why did you choose the comptroller general and 
not have this be a part of AHRQ? Any particular reason?
    Mr. ALLEN. In terms of selecting the panels?
    Mr. CAMP. Yes. Sort of the authority or the chain of 
command of this group would report to the comptroller general. 
I just was wondering your thought process behind that choice 
and not some other model.
    Mr. ALLEN. What we are trying to do is get a mix of some 
political oversight and some independence from politics. We are 
trying to get something like the MedPAC board. I mean, that's 
the goal. It's a bit of a difficult situation, because though 
we call for a study of completely independent funded centers, 
research centers, we think that probably, probably that leaves 
you never can be quite sure that you've got either the 
transparency and maybe the risk of being infiltrated by parties 
with interests in that kind of system.
    We think we've got the right balance, but that's why we 
were doing it. Trying to get a balance with some control and 
the right mix of control and independence.
    Mr. CAMP. All right. Thank you. Thank you, Mr. Chairman.
    Chairman STARK. Mr. Doggett?
    Mr. DOGGETT. Well, thank you very much for your testimony. 
I don't know of another Member of Congress who has given more 
thought than you have to different ways to improve our health 
care system, and I think this is one important aspect of that.
    As far as the funding, Chairman Stark. explored that with 
you a little bit. I know that, for example, on NIH, that's all 
done through appropriated funds. Should we be considering an 
alternative that focuses on appropriated funds to pay for this 
important public purpose?
    Mr. ALLEN. I would say that we believe, I believe, that an 
all payer system better reflects the sharing of the benefits. 
That you can try to pay for this entirely through appropriated 
funds, but then it becomes a heavier lift in terms of getting 
comparative effectiveness research on the scale that I believe 
it's needed.
    In fact, you alreadywe already have buy-in from insurance 
plans and some large employers who believe and understand that 
it will help both improve the quality of their plans and their 
management of their plans, and drive down their costs. So, the 
benefits are both public and private. There are savings to the 
public systems and there are savings to the private systems, 
and that's why we argue an all payer plan makes the most sense.
    Mr. DOGGETT. Thank you very much for your important 
recommendation.
    Chairman STARK. Thank you. Mr. Ramstad, would you like to 
inquire?
    Mr. RAMSTAD. Thank you, Mr. Chairman. Tom, good to see you 
as always.
    Mr. ALLEN. Thank you.
    Mr. RAMSTAD. I appreciate your kicking off this dialog. 
Like many concepts, I think comparative effectiveness sounds 
good in theory. Who can argue with comparison and 
effectiveness, comparative effectiveness? But I do have 
concerns about its implementation, just to follow up on Mr. 
Camp's line of questioning.
    My question is this. With respect to your legislation, I'm 
concerned about the power that the single comparative 
effectiveness entity or authority might have to determine 
what's covered by insurance, again, to follow up on Mr. Camp's 
questioning.
    Let me ask you specifically, would this advisory board, 
this comparative effectiveness advisory board, as provided in 
your legislation, make specific recommendations about which 
procedures, which devices, which drugs Medicare and private 
plans should cover or not cover?
    Mr. ALLEN. My understanding of the legislation the way it's 
meant to work is the answer is no. The answer is, as I 
understand it, simply the studies will be done. They will be 
available on a public website for those who want the 
information to review, and to use in making their own 
decisions. This legislation does not try to drive the 
decisionmaking process of other bodies.
    Mr. DOGGETT. So, it wouldn't preempt current law with 
respect to that decisionmaking process?
    Mr. ALLEN. That is correct.
    Mr. DOGGETT. It wouldn't say we recommend that Device A 
should be reimbursed and Device B should not?
    Mr. ALLEN. That is correct.
    Mr. DOGGETT. Okay. That's all I have. Thank you again, Tom. 
Mr. Chairman, I yield back.
    Chairman STARK. Thank you. Mr. Camp, we have some full 
Committee Members who are not on the Subcommittee. Could they 
thank you. Then I'd call one of our distinguished Members who 
is here, Mr. Becerra. Would you like to inquire?
    Mr. BECERRA. Mr. Chairman, I just wanted to acknowledge and 
welcome our colleague from Maine, Mr. Allen, for being here 
with us. I applaud him on his effort, but I will yield to my 
other colleagues.
    Chairman STARK. Ms. Schwartz, would you like to?
    Ms. SCHWARTZ. Thank you. I might hold my questions for the 
next panel, but I do think the interest in expanding our 
information about effectiveness and comparing that 
effectiveness is potentially very, very helpful to providers 
making that decision. I do share the concern I think of the 
other side. Mr. Camp mentioned about this information not being 
used in a way to limit access, particularly when it's a 
specific device or treatment is necessary for a particular 
person.
    So, it's interesting information I think partly how we 
expand and how we get that information out there, but then how 
do we actually make sure it's used in the best way possible to 
help our providers provide the best care for the consumers in 
this country.
    Chairman STARK. Mr. McDermott?
    Mr. MCDERMOTT. Thank you, Mr. Chairman. Tom, in answer to 
your question, or Congressman Allen, in answer to your 
questions to Mr. Camp and Mr. Ramstad, this is basically a 
toothless tiger. It will gather up information and have 
information on a website but have no impact, no intended 
impact. Is that correct?
    Mr. ALLEN. I think that sound, evidenced-based information 
on complicated topics that are widely available to providers 
and the public has an impact; that it drives decisions. I'll 
give you an example where it might have been effective in the 
past. Celebrex and Vioxx, two drugs to treat osteoarthritis, 
were advertised at the level, you know, several hundred 
millions of dollars went into advertising those drugs. They 
were best used, according to the research, for those people 
who, when taking ibuprofen, had gastrointestinal troubles.
    But they were marketed through Dorothy Hamill and others to 
a much broader to the entire population as if the entire 
population had something to gain. Simple comparative 
effectiveness studies on Celebrex, Vioxx and ibuprofen, to give 
just one example, might have driven a very different, number 
one, marketing strategy, but also a very different strategy by 
those who were prescribing those particular the two 
prescription drugs.
    I would add, specifically in the case of those drugs, if we 
had had broader information, surveys of existing literature, 
ongoing comparative effectiveness studies that were 
independent, the problems with Vioxx, for example, might have 
been discovered considerably sooner. That's why I don't believe 
that there's a need at this moment. I think we need to create 
the system and provide the information, and that information 
will drive decisionmaking in a helpful way.
    Mr. MCDERMOTT. The reason I asked the question is I guess 
if you've been here a while you sort of see stuff and you see 
it happen and you wonder about it. The quality control agency 
was a very effective agency in the past. Once they did a study 
on back surgery. They suggested that back surgery in many 
instances was not useful at all. They immediately were attacked 
by those folks who were the beneficiaries of that kind of 
surgery, not the patients, but the professionals involved in 
it. Their study was discredited, and there was a great big 
hooha because they were about to use this in Medicare in terms 
of making decisions about whether or not they were going to 
give it.
    Now I wonder about why more information. I know insurance 
companies. I've dealt enough with them, when we did the effort 
with Mrs. Clinton back in 1993. Insurance companies have panels 
where they decide what they're going to put out and what 
they're going to pay for, what they're going to use stem cell 
transplants for, or what they're going to use bone marrow 
transplants for, or what illnesses they're going towhat are 
they going to use and pay for. They don't share that 
information at all. You can't find out from Blue Cross/Blue 
Shield who makes those technical decisions.
    I guess I have some problem with creating another set of 
evidence-based medicine evidence, but not using it to drive 
decisionmaking in terms of how we control cost.
    It seems to me that we're just saying let the market do 
whatever it wants to do, and anybody who can come up with a new 
device comes in and somehow gets it approved and away it goes, 
there has to be some way you look at the evidence as to whether 
this device is actually better than this device, or this 
medicine better than this medicine. Otherwise, there is no end 
of the cost in health care. That's what we've got today. That's 
why we've got the prices going out of sight.I don't did you 
just figure you didn't want to use it yet until you had the 
information gathered? Or do you think it's not a good idea to 
have the government in the position of trying to protect the 
patient's cost?
    Mr. ALLEN. I would say that we believe that by itself, all 
by itself, bettera widerwider availability of better 
information, evidenced-based information that's generated by 
independent studies, not by the manufacturers of the device or 
the drug, and that serves everyone, that's available to 
everyone, it's available to the public and people running the 
public bodies. It's available to doctors and hospitals and 
other health care providers.
    That information is going to, we believe, just by being out 
there and being of the kind of information of which there isn't 
enough now, we think that is going to drive better health care 
decisions both in terms of quality and in terms of cost.
    Now, I mean this is, you know, my crystal ball only works 
some days and not today. But I think all by itself, having 
significantly more and better information on comparative 
effectiveness, is going to drive better decision making and 
save cost at the same time.
    Mr. MCDERMOTT. I hope you're right.
    Mr. ALLEN. I hope I am, too. Mr. Chairman?
    Chairman STARK. Go ahead.
    Mr. ALLEN. Can I just clarify one?
    Chairman STARK. Sure.
    Mr. ALLEN. When Mr. Camp was questioning me, I want to 
clarify some of the things I said right then. The comparative 
effectiveness advisory board reports ultimately to the 
Secretary of Health and Human Services and to Congress, not to 
the comptroller general. The comptroller general's only role is 
to oversee the advisory board's selection process, as it does 
for MedPAC. It's an attempt to get and you may have, I didn't 
say this, and you may have understood this. But it's the 
attempt to make that selection process of the advisory board 
independent of political considerations.
    Chairman STARK. Thank you. I want to thank you for your 
efforts and your testimony and assure you that as soon as one 
of my colleagues plagiarizes your good bill and introduces it 
under their own name, it will probably scoot right through this 
Committee.
    [Laughter.]
    Chairman STARK. You'll be left out there wondering what 
happened.
    Mr. ALLEN. Mr. Chairman, you can't be serious.
    Chairman STARK. Oh, ho ho. But thank you very much, and we 
appreciate your contribution to our venture here in learning 
about this.
    Mr. ALLEN. Thank you.
    Chairman STARK. You're going to be followed by a panel of 
government experts in this case; Dr. Carolyn Clancy, who is the 
Director of the Agency for Healthcare Research and Quality, and 
Dr. Peter Orszag, who is the Director of the Congressional 
Budget Office.
    Dr. Mark Miller, who advises us frequently and often and 
most helpfully on issues before us in the Medicare arena.
    After you are seated, get a chance to get settled, we will 
have you proceed in the manner in which I called you.Without 
objection, your full prepared testimony will appear in the 
record and you can enlighten us in any manner in which you are 
comfortable.
    Dr. Clancy, would you like to lead off?

  STATEMENT OF CAROLYN M. CLANCY, M.D., DIRECTOR, AGENCY FOR 
      HEALTHCARE RESEARCH AND QUALITY, ROCKVILLE, MARYLAND

    Dr. CLANCY. Thank you. Good morning, Mr. Chairman and 
Members of the Subcommittee. I am very pleased to testify 
before you on the exciting issue of comparative effectiveness. 
I ask that my written testimony and samples of AHRQ's 
comparative effectiveness reports and other materials be made 
part of the record.
    I am thrilled about the growing interest in and attention 
to enhancing the role of comparative effectiveness research in 
our health care system. I am particularly pleased to be able to 
tell you about the important work that my agency, the Agency 
for Healthcare Research and Quality, is doing in the area of 
comparative effectiveness.
    AHRQ's mission is to improve the quality, safety, 
efficiency, and effectiveness of health care for all Americans. 
Effectiveness in our mission includes comparative 
effectiveness: What is the right innovation or treatment for 
the right patient at the right time?
    Comparative effectiveness research is a means to an end. 
Our mission is fulfilled when health care decisionmakers, 
including patients, clinicians, purchasers, and policy-makers, 
use up-to-date evidence-based information about their treatment 
options to make informed health care decisions. Since they are 
making these decisions every day, we have a sense of urgency 
about this work.
    As a doctor and as AHRQ's director, I am very pleased that 
Congress recognized the programs and infrastructure the AHRQ 
has established for providing the health care system with 
scientific evidence when it authorized us to do comparative 
effectiveness research. This infrastructure enabled AHRQ to 
establish our Effective Health Care program and begin work 
rapidly without having to reinvent the wheel or create a new 
bureaucracy.
    In addition, our reputation as an unbiased and trusted 
source of information has moved the health care system to adopt 
and use the findings to improve the quality, safety, and 
effectiveness of health care.
    An important hallmark of the Effective Health Care program 
is transparency in all aspects of the process. Priorities for 
the program are set after receiving broad public input through 
Federal Register notices, public listening sessions, and other 
means.
    We have been very fortunate to have developed very 
cooperative relationships with a broad range of stakeholders, 
and we actively seek out comments and input from as many as 
possible.
    The public and all interested stakeholders have the 
opportunity to comment on the initial research priorities, 
framing of the specific questions, and draft reports. We also 
extensively focus test and seek input from consumers on 
materials that we develop specifically for them based on our 
comparative effectiveness reports.
    In addition to the open invitation to comment, 
manufacturers are notified when a study is begun that affects 
their products, and are invited to submit relevant studies and 
data. Input from manufacturers can raise questions and 
concerns. We have worked with our researchers to develop a 
process to minimize conflicts so we can create public/private 
partnerships with confidence.
    As AHRQ has implemented the Effective Health Care program, 
we have five significant observations to share. First is 
priority-setting. It is important to set clear priorities that 
meet the needs of all the stakeholders in health care. 
Therefore, end users and stakeholders must continuously provide 
input through an open and transparent process.
    Second is framing the research questions. Research must 
follow how clinicians and patients make health care decisions 
every day. After much deliberation, we decided that our 
research should focus on conditions rather than interventions. 
At the end of the day, that is how health care decisions are 
made. It is also very important to recognize the importance of 
updating findings frequently to incorporate new evidence that 
may change or modify the conclusions about what works best and 
for whom.
    The third relates to balancing benefits and harms. 
Comparative effectiveness research, by definition, must provide 
information on benefits and harms of a particular medication or 
intervention. Evaluating the balance of harms and benefits is a 
critical component of informed decisionmaking.
    Few interventions are risk-free, and for many chronic 
conditions the therapeutic goal is management of symptoms and 
disease state rather than cure. Oftentimes the decision comes 
with some assumption of harm by both patient and clinician, but 
with the understanding that the benefits are worth that risk.
    Fourth, research is a means, not an end. The ultimate goal 
of our research efforts is to develop timely, relevant 
information for decisionmaking. This requires us to go well 
beyond the products of traditional research, namely, scholarly 
articles, and translate findings in language and formats that 
are appropriate for different audiences. Our goal is that 
valid, reliable, and useful information be there when and where 
people need it.
    Fifth, trust is incredibly important. We view it as a 
process, not a structure. As Gail Wilensky has said, 
comparative effectiveness research can be risky business, and 
there may be winners and losers. While we have learned that 
there are often no clear winners and losers, but differing 
risks and benefits between different interventions, it is still 
important that there be a level playingfield among all 
stakeholders. For that reason, our program has adopted a policy 
of transparency and inclusion.
    In addition, it is clear that the program's success to date 
is dependent on effective collaboration with scientists from 
industry as well as academia. We are working very carefully to 
minimize conflicts in the analysis and development of 
knowledge, while taking advantage of the collective knowledge 
of a variety of different researchers through peer review and 
methodological work.
    The question of trust also extends to the integral role 
that patients plan in research. Although government and the 
private sector pay for research, patients assume the risks and 
benefits of enrolling in clinical trials and other studies. For 
that reason, it is critically important to recognize that these 
findings need to be carefully translated so that patients can 
receive the benefits of this knowledge in making their 
decisions.
    We all need to learn from the knowledge gained in research. 
But for patients, it can be a matter of life and death. Mr. 
Chairman, at some point we are all consumers of health care, so 
we can all recognize the importance of having unbiased, 
trustworthy information to inform our decisions.
    AHRQ's Effective Health Care program is a model for how 
this vision can be achieved. It is a transparent, participatory 
approach that is driven by the needs of users and which 
encourages broad engagement of stakeholders to explore and 
mitigate any controversies, and to expand opportunities for the 
rapid diffusion of findings of this research.
    In short, the Effective Health Care program represents a 
foundation on which a large investment in comparative 
effectiveness can be built. Thank you very much, and I would be 
pleased to answer any questions.
    [The prepared statement of Dr. Clancy follows:]

       Prepared Statement of Carolyn M. Clancy, M.D., Director, 
    Agency for Healthcare Research and Quality, Rockville, Maryland

    Good morning, Mr. Chairman and Members of the Subcommittee. I am 
Dr. Carolyn Clancy, the Director of the Agency for Healthcare Research 
and Quality (AHRQ), an agency of the U.S. Department of Health and 
Human Services (HHS). I am very pleased to testify before you on the 
exciting issue of comparative effectiveness. I am thrilled about the 
growing interest in, and attention to, enhancing the role of 
comparative effectiveness research in our health care system. And I am 
particularly pleased to be able to tell you about AHRQ's important 
efforts in this area of research.
    This is a very interesting time in the history of health and 
medicine. Our investments in biomedical research have resulted in many 
new diagnostic and therapeutic options. Clinicians and patients can 
often now choose among an expanded array of choices for treating 
hypertension, heart failure, HIV, mental illness, and other chronic 
illnesses, and unprecedented innovations in diagnosis and prediction 
bring us closer to a vision of personalized health care than ever.
    We also are beginning to reap the benefits from the advances in 
health information technology (health IT) that can bring this 
information immediately to clinicians, patients, and others when and 
where they need it. Health IT also is enhancing our research capacity 
and our ability to diffuse breakthroughs quickly and efficiently 
throughout the health care system. Health IT can make research a 
natural by-product of delivering health care.
    While this brave new world of health care presents wonderful 
opportunities, it also creates challenges. Chief among them is how to 
evaluate these innovations and determine which represent added value, 
which offer minimal enhancements to current choices, which fail to 
reach their potential, and which work for some patients and not for 
others. The need to develop better evidence about the benefits and 
risks of alternative choices is imperative.
    The mission of AHRQ is to improve the quality, safety, efficiency, 
and effectiveness of health care for all Americans. Effectiveness sits 
squarely in our mission--what is the right treatment for the right 
patient at the right time.
    Comparative effectiveness research is a means to an end. Our 
mission is fulfilled when health care decision makers including 
patients, clinicians, purchasers, and policymakers--use up-to-date, 
evidence-based information about their treatment options to make 
informed health care decisions.This goal was the inspiration for the 
creation of AHRQ by those Members of Congress who grasped the power of 
information to improve the health care system and the health of 
Americans.

Effective Health Care Program
    AHRQ was granted authority under Section 1013 of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) to 
conduct and support evidence syntheses and research on topics of 
highest priority to Medicare, Medicaid, and the State Children's Health 
Insurance Program (SCHIP).
    I would like to thank Congress for its recognition of the programs 
and infrastructure that AHRQ has established for providing the health 
care system with the scientific evidence that it needs to provide safe, 
high quality effective health care. AHRQ's Evidence-based Practice 
Centers (EPCs), Centers for Education and Research on Therapeutics, and 
other research programs have become a trusted, unbiased national source 
of information on health care diagnostics and treatments
    These programs are an integral part of the AHRQ's Effective Health 
Care program, which was created under the authority of Section 1013. 
AHRQ was able to establish the Effective Health Care program and begin 
work very quickly because of our solid, existing research enterprise.
    The Secretary of HHS, Michael Leavitt, has established priorities 
for research conducted in the Effective Health Care Program by 
establishing high priority conditions that have a major impact for the 
Medicare, Medicaid, and SCHIP programs. To be effective, comparative 
effectiveness research must be relevant to its users. Decision makers 
are often faced with situations for which multiple different treatments 
are relevant at different times. For example, should a fifty-five-year-
old woman with a scan showing greatly decreased bone density take 
drugs, increase Vitamin D and calcium intake, focus on weight-bearing 
exercise, or watchfully wait? We know that drugs are effective, but 
there is limited information on their long-term effects. Some women 
will develop kidney stones after increased calcium; current evidence 
does not allow precise formulation of an effective exercise 
prescription; and many women will never experience a fracture.
    The key to success for this research is that it provides evidence 
that informs the choices confronting clinicians and patients and, where 
possible, should closely align with the sequence of decisions they 
face. As MMA Section 1013 directs, we also need to ensure that findings 
are frequently revisited, so they remain relevant and up-to-date. New 
evidence, such as a genetic test that identifies people at increased 
risk of untoward outcomes, affects comparative effectiveness and should 
be incorporated into these reviews at the appropriate times.
    Under the statute, the Secretary of HHS is required to establish 
priorities, informed by a transparent priority-setting process that 
includes all stakeholders. Priorities for the Effective Health Care 
Program therefore are set after receiving broad public input through 
Federal Register notices, public listening sessions, and other means.
    There was much discussion within HHS about how to approach these 
priorities. During our discussion of research on diseases or 
conditions, for example, we debated specific questions about treating 
diabetes and heart disease, and whether our research should center on 
particular medications and interventions, such as stents or proton pump 
inhibitors.
    We decided to take a disease- and condition-based approach because, 
at the end of the day, that is how health care decisions are made. A 
patient comes to the health care system with a condition or disease, 
and all decisions, including how best to treat it, follow.
    In December 2004, based on input from stakeholders, the Secretary 
of HHS identified 10 priority conditions--all of special significance 
to the Medicare program--to be the first addressed by the Effective 
Health Care Program. These conditions are:

          Arthritis and nontraumatic joint disorders
          Cancer
          Chronic obstructive pulmonary disease/asthma
          Dementia, including Alzheimer's disease
          Depression and other mood disorders
          Diabetes mellitus
          Ischemic heart disease
          Peptic ulcer/dyspepsia
          Pneumonia
          Stroke, including control of hypertension

    AHRQ's Effective Health Care Program comprises three parts. The 
first capitalizes on effectiveness research conducted by AHRQ's 
existing 13 EPCs, which were created in 1997. The EPCs develop 
comparative effectiveness reviews which focus on treatments for the 
priority conditions. These reports synthesize currently available 
scientific evidence, including both published and unpublished studies, 
comparing treatments, including drugs, to determine relative benefits 
and risks, and wherever possible, measure these outcomes for 
subpopulation groups. In addition, the EPCs identify major gaps in the 
existing knowledge base.
    To help fill these gaps, AHRQ established the second part of the 
Effective Health Care program, called the DEcIDE network (Developing 
Evidence to Inform Decisions about Effectiveness), which will focus on 
conducting rapid-cycle research to address specific issues that do not 
necessitate larger, more time-consuming randomized clinical trials. The 
DEcIDE network consists of 13 research centers that have access to 
databases that contain clinical information for more than 50 million 
patients but do not identify them individually.
    The third part of the Effective Health Care program is the John M. 
Eisenberg Clinical Decisions and Communications Science Center, based 
at the Oregon Health and Science University's Department of Medicine. 
The Eisenberg Center was established to ensure that the findings of our 
comparative effectiveness research are translated into formats that are 
understandable for all potential users. The center--named the John M. 
Eisenberg Center in honor of AHRQ's late director--assists in ensuring 
that effectiveness research leads to real-world quality improvements by 
translating complex scientific findings into understandable language 
for different audiences. The Center will help assure that reports are 
presented in formats that make them useful to a wide range of audiences 
and also will develop tools that encourage and empower consumers to 
make informed health care decisions.
    An important hallmark of the Effective Health Care program is 
transparency in all aspects of the process. The transparency begins 
with the open process for setting research priorities, described 
earlier. The public and all interested stakeholders also have the 
opportunity to comment on the framing of specific research questions, 
as well as commenting on draft reports. In addition to the open 
invitation to comment, manufacturers are notified when a study is begun 
on one of their products and are invited to submit relevant studies and 
data.
    Draft research questions and reports are posted on AHRQ's Effective 
Health Care Program Web site (www.effectivehealthcare.ahrq.gov), and 
the Web site has a listserv that automatically notifies interested 
parties when draft questions or draft reports are posted.

Comparative Effectiveness Reviews

    To date, AHRQ has released seven comparative effectiveness reviews. 
These reviews can be found on the Effective Health Care Program Web 
site, discussed above. They are:

        Gastroesophageal Reflux Disease (GERD)

          For management of gastroesophageal reflux disease, 
        medications called proton pump inhibitors can be as effective 
        as surgery in relieving the symptoms and improving quality of 
        life.

        Breast Cancer Diagnosis

          Among women who receive an abnormal mammography findings or 
        physical exams, four common noninvasive tests (magnetic 
        resonance imaging, ultrasonography, positron emission 
        tomography scanning, and scintimammography) are not accurate 
        enough to routinely replace biopsies.

        Managing Anemia In Cancer Patients

          Among cancer patients undergoing chemotherapy or radiation, 
        there is no clinically significant difference between epoetin 
        and darbepoetin in the management of anemia. The drugs show no 
        clinically significant difference in improving hemoglobin 
        concentration and reducing the need for transfusion.

        Osteoarthritis Drugs

          Non-steroidal anti-inflammatory drugs (NSAIDs) and COX-2 
        inhibitors present similar increased risks of heart attacks 
        while offering about the same level of pain relief for patients 
        with osteoarthritis. The exception is naproxen, which presents 
        a lower risk of heart attack for some patients than other 
        NSAIDs or COX-2 inhibitors.

        Renal Artery Stenosis

          Increasing numbers of patients with narrowed kidney arteries 
        are undergoing vessel-widening angioplasty and placement of a 
        tubular stent, but evidence does not show a clear advantage of 
        that treatment over prescription drug therapy.

        Off-Label Use Of Atypical Antipsychotics

          Some newer antipsychotic medications approved to treat 
        schizophrenia and bipolar disorder are being prescribed for 
        depression, dementia, and other psychiatric disorders without 
        strong evidence that such off-label uses are effective. 
        Research is urgently needed for new treatments of dementia 
        patients with severe agitation.

        Second-Generation Antidepressants

          Today's most commonly prescribed antidepressants are 
        similarly effective to first-generation antidepressants and 
        provide relief to about six in 10 patients, but current 
        evidence is insufficient for clinicians to predict which 
        medications will work best for individual patients. Six in 10 
        patients experience at least one side effect, ranging from 
        nausea to sexual dysfunction.

    In January 2007, AHRQ released the first summary guide for 
consumers and clinicians derived from a comparative effectiveness 
report by the Eisenberg Center. The consumer report, titled Choosing 
Pain Medicine For Osteoarthriti s, translates the information from the 
comparative effectiveness report on osteoarthritis drugs into language 
that will help consumers choose among their treatment options. The 
companion guide, Choosing Non-Opioid Analgesics for Osteoarthritis, 
further synthesizes the evidence into a resource that can help 
clinicians work with their patients to make informed decisions about 
treatments for osteoarthritis.
    AHRQ has a series of upcoming reports that deal with critically 
important issues facing the health care system. They include:

          Medications for type 2 diabetes
          ACEIs (Angiotensin-converting enzyme Inhibitors) vs. 
        ARBs (angiotensin II receptor antagonists) for high blood 
        pressure
          Surgery vs. stents coronary artery disease
          Medications and other treatments (e.g., diet, 
        exercise) for low bone density

Health Information Technology

    I would like to mention briefly the role of health IT, which will 
make it easier for researchers to gather information for their research 
and for users of research findings to get information in real time when 
they need it. The health care system's growing investments in health IT 
provide us with an unprecedented opportunity for redefining the 
possibilities of observational studies, accelerating and targeting the 
uptake of relevant information, and providing feedback to the 
biomedical enterprise itself.
    Health IT will make it possible for research to answer the pressing 
questions facing the health care system more quickly and efficiently. 
In the future, health IT will provide us with the vehicle for 
transforming our health services research enterprise so that we can 
evaluate the effectiveness of interventions and treatments in real time 
as a byproduct of providing care.
    AHRQ's Fiscal Year 2008 budget request includes $15 million for a 
personalized health care initiative that will begin the infrastructure 
for a federated system of databases that can help answer critical 
comparative effectiveness questions. This system would enable 
researchers to match treatments and outcomes, and in that way learn 
from the nation's day-to-day medical practice and improve safety and 
effectiveness of medical treatments.
    Health IT also will greatly improve the ability to diffuse evidence 
and information more quickly throughout the health care system. For 
example, clinical decision support tools will make it possible to 
deliver relevant information to clinicians and patients, at the point 
of decision making. Most commonly envisioned as a pop-up reminder on a 
screen, clinical decision support should include information 
communicated directly to patients and caregivers at home--by phone, 
computer, or by other means.

Conclusion
    As AHRQ has implemented the Effective Health Care program, we have 
some significant observations:

          Priority setting: It is important to set clear priorities 
        that meet the needs of all of the stakeholders in the health 
        care system. Therefore, end users and stakeholders must 
        continuously provide input through an open and transparent 
        process.

          Framing the research questions: Research must track closely 
        with how clinicians and patients make health care decisions 
        every day. The Secretary's decision to use a disease- and 
        condition-based approach to priorities embodies this 
        perspective. It is also very important to recognize the 
        importance of revising findings frequently to incorporate new 
        evidence that may change the conclusions of what works best and 
        for whom.

          Balancing benefits and harms: Comparative effectiveness 
        research must provide information on benefits and harms of a 
        particular medication or intervention. Evaluating the balance 
        of harms and benefits is a critical component of informed 
        decision making. Few interventions are risk free, and for many 
        chronic conditions the therapeutic goal is management of 
        symptoms and disease state rather than cure. Often times, the 
        decision comes with some assumption of harm--by both patient 
        and clinician--but with the understanding that the benefits are 
        worth that risk.

          Research is a means, not an end: The ultimate goal of our 
        research efforts is the development of timely, relevant 
        information for decision making. This requires us to go beyond 
        the products of traditional research, namely scholarly 
        articles, and translate findings into language and formats that 
        are appropriate for different audiences. Creating evidence and 
        information that is not useful and accessible, or that does not 
        take advantage of the latest communication technologies and 
        vehicles, is a missed opportunity.

          Trust as a process, not a structure: As has been stated, 
        comparative effectiveness research can be a risky business, and 
        there are winners and losers. Therefore, it is important that 
        there be a level playing field among stakeholders. AHRQ's 
        Effective Health Care program has adopted a policy of 
        transparency and inclusion. Manufacturers are notified when a 
        study is begun, are invited to submit relevant studies and 
        data, and have the opportunity--along with any other interested 
        party--to comment on the framing of the specific research 
        questions as well as draft reports. In addition, it is clear 
        that the program's success is dependent on effective 
        collaboration with scientists from industry as well as 
        academia. At the same time, we ensure that the authors of the 
        comparative effectiveness reports are free of conflict to make 
        sure that the results are not perceived as being biased in any 
        way.

    The question of trust also extends to the integral role that 
patients play in research. Although government and the private sector 
pay for research, patients assume the risks and benefits of enrolling 
in clinical trials and other studies. A question that is the subject of 
debate is whether study findings can ethically be kept secret from 
other researchers and patients themselves. We all need to learn from 
the knowledge gained in research, but it can be a matter of life and 
death for patients. We must move to an atmosphere where it is 
unacceptable to hold back research findings that may have an impact on 
the care that patients receive.
    In conclusion, the U.S. health care system is poised to take 
advantage of advances in science and health information and 
communications technology in ways that have previously only seemed like 
something out of science fiction.
    The need for valid, reliable, and accessible information on the 
comparative benefits and potential harms of treatment options has 
gained an urgency due to recent policies to promote the adoption of 
interoperable health IT, continued expansion of diagnostic and 
treatment options, increased consumer interest in health and health 
care decisions, and broad interest in improving value.
    AHRQ's Effective Health Care program is a model for how this vision 
can be achieved: A transparent, participatory approach that is driven 
by the needs of users and encourages broad engagement of stakeholders 
to mitigate any expected controversies and to expand opportunities for 
diffusion of findings of comparative effectiveness research. The 
Effective Health Care Program represents a foundation in which a larger 
investment in comparative effectiveness can be built.
    Thank you very much and I would be pleased to answer any questions.

                                 

    Chairman STARK. Thank you, Doctor.
    Dr. Orszag?

 STATEMENT OF PETER R. ORSZAG, Ph.D., DIRECTOR, CONGRESSIONAL 
                         BUDGET OFFICE

    Mr. ORSZAG. Thank you, Mr. Chairman and Members of the 
Committee. My oral testimony this morning will make three basic 
points.
    First, the central fiscal challenge facing the United 
States is the growth of health care costs, not aging, despite 
what many media portrayals would suggest. This chart 
illustrates the point. Over the past four decades, costs per 
beneficiary in Medicare and Medicaid have grown 2.5 percentage 
points faster than income per capita. If that rate of growth 
continued, you wind up on the top line. Medicare and Medicaid 
would grow from 4\1/2\ percent of the economy to 20 percent of 
the economy by 2050.
    The bottom dotted line shows you what happens if that 
excess cost differential were zero, and isolates the effect of 
aging on the programs. I think you can see that where you wind 
up on that bottom line is higher than where you start. So, 
there is some effect of aging, but that difference is much 
smaller than the difference between the bottom dotted line and 
the top line in 2050.
    In other words, the central long-term fiscal challenge 
facing the United States is how rapidly health care costs grow 
compared to income per capita, not the aging of the population 
or the coming retirement of the baby boomers.
    These rising health care costs, by the way, also represent 
a challenge not only for the Federal Government, but for 
private payors. Indeed, costs per beneficiary in the public 
programs have tracked costs per beneficiary in the rest of the 
health sector over long periods of time.
    My second point is that a substantial opportunity exists to 
constrain health care costs, both in the public programs and in 
the rest of the health system, without adverse health 
consequences. Perhaps the most compelling evidence in favor of 
this observation is the substantial geographic variation in 
costs per beneficiary across parts of the United States that 
cannot be explained by the underlying riskiness of the 
patientand I present the chart here, with the darker areas 
being higher spending regionsand which do not translate into 
higher life expectancy or measured improvements in other health 
statistics in the higher spending regions.
    Furthermore, hard evidence is often unavailable about which 
treatments work best for which patients or whether the added 
benefits of more expensive but more effective care are worth 
the cost. The variation in treatments across the United States 
is often greatest for those types of care for which evidence 
about relative effectiveness is lacking.
    Various Federal efforts to conduct this kind of comparative 
effectiveness have been undertaken in the past and some 
continue today, but on a scale that is significantly smaller 
than most observers believe is warranted.
    If policy-makers want to expand Federal efforts to study 
comparative effectiveness, the effort could be organized and 
funded in various different ways. My written testimony 
describes some of these options, and a forthcoming CBO report 
that has been requested by the Senate Finance and Senate Budget 
Committees will go into even more detailed analysis of them.
    However the effort is organized, having more health records 
available in electronic form would facilitate the use of 
existing data for research, which could create new 
opportunities for examining what works and what doesn't in a 
rigorous way.
    Finally, comparative effectiveness research holds the 
potential to reduce health care spending significantly over the 
long term without having adverse effects on health. To effect 
medical treatment and reduce health spending in this way, the 
results of comparative effectiveness research would have to be 
used in ways that changed the behavior of doctors, other 
professionals, and patients.
    For example, the higher value care identified by 
comparative effectiveness research could be promoted in the 
health system through financial incentives, the payments that 
doctors receive, or the cost-sharing that patients face. Making 
substantial changes in payment policies or coverage under the 
Medicare program to reflect information about comparative 
effectiveness would almost certainly require legislation.
    I must also note that getting to the point where additional 
research on comparative effectiveness could have a noticeable 
impact on health care spending would take time. In addition to 
the time required to get the new activities underway and up to 
scale, a lag would exist before the results were generated, 
particularly if they depended on new clinical trials.
    As a result of these lags and other implementation lags, it 
is relatively unlikely that there would be any significant net 
reduction in costs over the next decade or so. But despite all 
these caveats, it is so rare as CBO director that I get to have 
the ability to say that anything holds the potential to reduce 
costs over the long term that I want to repeat that final 
observation and repeat my basic conclusions, which are:
    The United States is on an unsustainable fiscal course 
largely because of projected health care costs. There is a 
substantial amount of variation in those costs that cannot be 
explained by the underlying riskiness of the patients and that 
does not translate into better health outcomes for the 
population. Additional research on comparative effectiveness, 
if combined with incentives to implement the results of that 
research, hold substantial potential to reduce health care 
costs over the long term without impairing, and perhaps even 
improving, the health of Americans.
    Thank you very much, Mr. Chairman.
    [The prepared statement of Mr. Orszag follows:]

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    Chairman STARK. Thank you very much.
    Dr. Miller?

 STATEMENT OF MARK MILLER, Ph.D., EXECUTIVE DIRECTOR, MEDICARE 
                  PAYMENT ADVISORY COMMISSION

    Dr. MILLER. Chairman Stark, Ranking Member Camp, and 
distinguished Members of the Subcommittee, much of MedPAC's 
work is devoted to improving the efficiency of the Medicare 
Program either through reducing unnecessary costs or improving 
the quality of care for the dollars that we do spend.
    The Commission is acutely aware of the long-run 
sustainability problems facing the Medicare Program. In 
addition to what Peter has said, I would add that the Part A 
trust fund currently looks like it will be exhausted in 2019. 
At historical rates of taxation, Medicare will consume 24 
percent of personal and corporate income tax by 2030. The rate 
of change in part B premiums and copayments is faster than 
beneficiaries' incomes, making Medicare more and more 
unaffordable.
    Medicare needs a broad range of policy changes to gain 
control of spending without sacrificing quality. One of the 
changes is to better understand what works in health care and 
what does not work. Comparative effectiveness analysis 
evaluates the relative effectiveness of drugs, devices, 
therapies, and procedures. The outcomes of this analysis can be 
evaluated in terms of clinical outcomes, such as mortality and 
morbidity; functional outcomes, like quality of life and 
patient satisfaction; and economic outcomes, such as cost-
effectiveness.
    The private sector is unlikely to produce this type of 
information on the scale that is needed because it is costly 
and what it has produced can be used by anyone, including their 
competitors. Moreover, private payors fear litigation on being 
the first to act on comparative effectiveness information. We 
also point out that there is recent research in JAMA and other 
clinical journals that indicate that the results of studies 
sometimes are influenced by the source of funding.
    There is a lot of positive work being done by Federal 
agencies, AHRQ, NIH, CMS, and VA. Here the Commission, however, 
has two concerns. No Federal agency has its mission and budget 
devoted solely to the production of competitive effectiveness 
information, and consequently, the information will not be 
produced on a sufficient scale.
    Second, none of these agencies are organized and funded in 
a way that allows them to be truly independent. For the 
Medicare Program, competitive effectiveness information could 
be used to differentiate payment among providers to encourage 
the pursuit of evidence-based medicine. It could be used to 
avoid higher cost, expensive services when there is no clinical 
evidence that they are better than existing treatments. Other 
researchers have discussed the idea of requiring manufacturers 
to enter risk-sharing relationships where payments are rebated 
to a payor if a product does not perform as expected.
    The Commission has examined this issue over the last 3 
years, and in our forthcoming June report, we recommend that 
the Congress charge an independent entity to sponsor 
comparative effectiveness research and disseminate it to 
patients, providers, and payors.
    To be clear, this organization would not be involved in 
coverage and payment policy decisions. It would generate 
information only, information to be used by patients and 
providers in making clinical decisions, and by payors to 
determine coverage and payment.
    The Commission has discussed the characteristics of this 
entity. It should be independently governed and have a stable 
funding source. I will return to those two points. It should 
have transparent processes in terms of the agenda-setting, the 
research results, and the methods used. It should seek input 
from all stakeholders, establish consistent research methods, 
and establish ethical standards for the conduct of this 
research. As I mentioned, it should disseminate the 
information.
    Returning to governance, the Commission has concerns that 
any Federal agency is truly independent when it comes to 
financing and disseminating unpopular studies and results. The 
Commission, however, is also equally concerned that a wholly 
private organization would not be transparent and objective 
enough to assure credibility. The Commission favors a public/
private governance structure that would resolve these concerns 
and broadly represent patients, providers, and payors in the 
two sectors.
    On financing, and public financing specifically, the 
Commission discussed a continuum of options, from the 
appropriations process to mandatory funding streams. The 
Commission favors a stable funding source, and on balance that 
probably means a mandatory source would be more stable while 
retaining congressional oversight.
    Similarly, the Commission discussed a continuum of private 
financing mechanisms, from voluntary donations to taxes. Again, 
the Commission favors a more stable funding stream, and some 
researchers have suggested, for example, proposing a small tax 
on health insurance premiums to fund this effort.
    In closing, the Commission was also concerned that this 
endeavor not entail creating or recreating existing resources. 
There is an available infrastructure in the Federal agencies, 
the states, and the private sector. Based on new authority, 
AHRQ has created research networks and networks to disseminate 
study results. One could envision an entity with a public/
private governance structure which sets an agenda, sponsors 
research that is conducted by both private organizations and 
Federal agencies, and then disseminates the information to 
patients, payors, and providers.
    I look forward to your questions.
    [The prepared statement of Mr. Miller follows:]

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    Chairman STARK. Well, I would start right there. All of you 
have touched on this issue of who would be in charge or what 
kind of a bureaucracy or agency would handle this work. Mark, I 
direct this to you: Does there exist in our world today an 
agency, whether it studies defense or space or is there an 
agency that would meet the standards that you suggest?
    Dr. MILLER. The Commission discussed a couple of models 
that one could use. The notion of like a Federal Reserve Board, 
where you have a board that is appointed and operates with some 
degree of independence. There are arrangements in the Federal 
agencies where you have combinations of the Federal agency and 
a not-for-profit corporation, which can take Federal and 
private dollars to execute agendas.
    Chairman STARK. Such as?
    Dr. MILLER. There is a list in our testimony. But these 
things can be things like a Jet Propulsion Laboratory 
associated with NASA, things I am not necessarily expert in. 
But there is a list of them in our testimony.
    The concern there would be in a situation like that whether 
the Federal agency would be truly able to operate 
independently. I think that is what drove the Commission in the 
direction of considering a public and private governance 
structure that would be able to set the agenda and direct the 
research. There are a couple of models out there that people 
could work with.
    Chairman STARK. Dr. Clancy, your agency has been suggested 
as a repository or operator of all this. What do you think we 
should do? Do you want us to put it in AHRQ and cut you loose 
from HHS, or what would you suggest?
    Dr. CLANCY. Well, first let me say that the Department and 
Secretary Leavitt have been very supportive of this work, and 
he believes that this is quite critical to a focus on getting 
better value in health care, which I think you and your 
colleagues share a strong interest in as well.
    We believe that doing this research well and rapidly and 
bringing the kind of information to patients and clinicians 
that they need today is, by definition, a team sport, and that 
we have the teams and infrastructure in place to make the most 
of an investment as rapidly as possible. If one starts all over 
again, it is a little bit like that movie, ``We Are Marshall.'' 
Right? You can get there, but it is going to take some time to 
build a new infrastructure and so forth.
    More important, I think that we are very proud of the 
relationships that we have built with a variety of 
stakeholders. Even some industries that were worried about work 
that we were doing came around when we were done to say thank 
you. We were treated fairly. This was transparent. We had a 
say. To the extent that we had information to share that could 
also be shared broadly, you were there to help us, and so 
forth.
    So, I think that we have begun to set a track record here 
and that that is an important consideration.
    Chairman STARK. But it would be my understanding that the 
Secretary, whoever that might be, could sequester the results 
of your reports at any time. For example, if Tommy Thompson 
were back in that seat and you came out with something 
criticizing Swiss cheese, there is no way that report would 
reach the public under any circumstances, I think, the way you 
are structured. Is that not correct?
    Dr. CLANCY. No. Actually, for this program, that is not 
correct, in part because we have set it up to be transparent 
from beginning to end, including posting the draft reports. In 
fact, those draft reports are often covered by electronic 
newsletters and so forth with people voicing their concerns or 
issues or other particulars they want to raise. We think that 
is great because
    Chairman STARK. What you are suggesting is AHRQ now can 
operate without any political influence on the results of its 
work?
    Dr. CLANCY. That has been our record with this program, 
yes.
    Chairman STARK. That is good to know.
    Dr. Orszag, just one question. I am afraid I know the 
answer. But it is often troublesome to us, good and bad, I 
guess, that we can't get scored for savings where we are not 
required by law to spend the money. For example, everybody in 
this room would probably agree that for every dollar we spent 
on early childhood preventive medicine, we would save $5 over 
the next 10 years of that child's life. But the $5 we save you 
won't score us as a savings because we are not required to 
spend it.
    Is there any thought, any hope, that weI guess you would 
call it more dynamic scoring, but that would turn the whole 
budget process on its head. But is there any way out of that 
dilemma, where the prospective, I guess, social savings to the 
country as a whole would help us?
    You mentioned, and you bring it out: We spend five times as 
much on medical care today as we spend on the whole automobile 
industry. Think about that, and look at all the traffic jams we 
have. But we are spending five times as much in our gross 
domestic product on medical care as we do on automobiles, which 
is something to think about when you are commuting.
    But what about is there any chance we could find a 
different way to score some kinds of savings?
    Mr. ORSZAG. Let me say things three things. The first is 
and the preventive medicine example that you raised often has 
very long-term payoffs in terms of cost savings. The budget 
window, which is chosen by the Congress, not by CBO, has been 
five to 10 years. So, that is one inherent limitation in this 
process that in many cases, cost savings over very long periods 
of time are just outside the window that you normally look at.
    The second thing is that CBO is reexamining many issues to 
see whether there are offsetting behavioral responses and other 
things that do not get into dynamic scoring, which involves 
macroeconomic responses. There are a variety of questions that 
we are currently reexamining as new evidence comes to light. We 
would welcome evidence that would help us in that effort.
    The final thing is on dynamic analysis itself, CBO and the 
Joint Committee on Taxation and other official entities have in 
recent years started to do dynamic analysis on some legislative 
proposals. We are reexamining how we do that also so that to 
the extent that on the spending side of the budget there are 
things that have high economic returns and evidence in that 
favor, that could be incorporated at some point into the 
process.
    But we are currently just reexamining the evidence to build 
the evidence base, and we are not at the point where we are 
able to do that yet.
    Chairman STARK. Thank you.
    Mr. Camp?
    Mr. CAMP. Thank you, Mr. Chairman.
    Dr. Miller, do I understand that one of the models that you 
are suggesting for this might be similar to the testimony we 
are going to be hearing in a few minutes from Dr. Wilensky 
about maybe having a federally funded research and development 
center that is mainly funded by the government but attached to 
AHRQ? Is that one of the examples I thought I heard you 
describe?
    Dr. MILLER. Yes. That is one of the models that is reviewed 
in our report. The various pros and cons of that are talked 
through. I would just say that in making that point, the 
concern would be that the Federal agency that it is attached to 
would have the latitude to disseminate research, set an agenda 
and disseminate research, even if it was reaching conclusions 
that are unpopular.
    I think that is why the Commission was moving more toward 
some governance structure that was more separate than a Federal 
agency. But it is one ofyes, it is one of the models.
    Mr. CAMP. You mean your concern is that the Federal agency 
would disseminate information that is unpopular?
    Dr. MILLER. It would be unable to disseminate such 
information.
    Mr. CAMP. Unable to because of political interference?
    Dr. MILLER. Correct.
    Mr. CAMP. Dr. Orszag, you mentioned that comparative 
effectiveness with the right incentives could be a real help. I 
notice in your written testimony you mention that there might 
be the incentive might be to pay for additional costs of less 
effective treatment, for example, the concern being that and I 
would ask both you and Dr. Clancy to comment on this there are 
certain chronic conditions that have unique circumstances that 
respond to different treatments or different drug regimens.
    There may not be one medication that fits every particular 
situation. Just for example, there are 15 drugs to treat 
patients with epilepsy, and two patients with epilepsy could 
suffer the exact same seizures but they require different 
medications based on their body composition or other factors.
    How can we ensure that a system that has comparative 
effectiveness ensures each unique patient has access to the 
medication that is most effective?
    Mr. ORSZAG. Well, and as my written testimony emphasizes, 
one of the goals of comparative effectiveness research should 
be to identify the sub-populations for which different 
treatments or interventions are more or less effective so that 
it is not such a blunt conclusion.
    Incentive structures could then be tied off of that more 
disaggregated, more nuanced data. I agree with you that a blunt 
approach could not only be counterproductive, but backfire. One 
of the goals of this effort, presumably, would be to get a 
finer level of disaggregation about what works and what 
doesn't.
    Mr. CAMP. All right. Dr. Clancy, any comment?
    Dr. CLANCY. Yes. Just to make the point that the question 
you are raising in my mind reinforces exactly the importance of 
this kind of research. You know, today the vast majority of 
patients who are lucky enough to have insurance actually do 
make differential decisions based on tiering of pharmaceutical 
benefits and so forth.
    Oftentimes they have to do that in the absence of 
information, and their clinicians actually don't have bits of 
information, but it is not organized in a way that helps them 
sit down with a patient and say, these are the options that 
would be best for you.
    So, that is actually the vision we have of how this 
information would work.
    Mr. CAMP. Do you have any thoughts just on Dr. Miller's 
comments that if this research were connected with a Federal 
agency, they would be unable to release anything unpopular 
givenhow do you square that with your other comments about the 
transparency?
    Dr. CLANCY. Well, the point about transparency is that you 
have got broad engagement of many people in health care who 
care a lot about the information. So, you will be hearing from 
the American College of Physicians and others in the next 
panel. If they care about it, they are going to be saying, 
okay, so where is it, I mean, in the event that something that 
has not been in our experience were to occur. That is actually 
very, very helpful.
    Not only that, they become a very helpful and supportive 
dissemination partner because at the end of the day, I am an 
internist. Many internists would actually prefer to get 
information that is coming from the College of Physicians than 
from any government agency. I don't take that personally; it is 
just because the College brings a certain level of credibility 
to it.
    So, we see that engagement throughout the process as quite 
critical to the success of this work.
    Mr. CAMP. All right. Thank you. Thank you, Mr. Chairman.
    Chairman STARK. Thank you. Mr. Doggett?
    Mr. DOGGETT. Thank you for your testimony.
    Dr. Clancy, if I might inquire if you about a specific that 
may have some implications for other kinds of services, and 
that is imaging, for which Medicare has seen such an increase 
in cost.
    While comparative effectiveness information is certainly 
useful in looking at imaging, I hear concerns voiced by 
radiologists that this greatly increases the administrative 
burden and that it encourages insurance companies to require 
precertification and other types of utilization management 
restrictions to limit imaging services.
    How do we ensure that the comparative effectiveness 
information is used to improve quality without weighing down 
the health care provider with greater administrative burdens?
    Dr. CLANCY. First, let me say that I am very pleased that 
we have had a number of collaborative opportunities and ongoing 
relationships with the College of Radiology and others. In many 
ways, that college kind of gets the work we do more than some 
others, which is a good thing.
    I don't think you can entirely guard against it. But I do 
think if the information is transparent both in terms of what 
are the facts and what do we not know, then people have good 
grounds to ask questions and to push back if there are policies 
that are actually getting in the way of what is good patient 
care.
    Mr. DOGGETT. I know that you have done one report on the 
effectiveness of noninvasive diagnostic tests for breast 
abnormalities. Do you have plans to investigate the comparative 
effectiveness for any other conditions where imaging is used as 
a diagnostic tool?
    Dr. CLANCY. I don't know, but I will be happy to provide 
that answer in writing. I don't have a good list with me.
    Mr. DOGGETT. Sure. Should comparative effectiveness data 
also be used to develop imaging certification standards that 
would assure that the provider is properly trained to provide 
the imaging scan, has suitable equipment, and has the training 
to read the scan effectively?
    Dr. CLANCY. We think that is very important in terms of 
getting at dimensions of improving quality of care. But I would 
say that most people would say that is not a part of 
comparative effectiveness per se.
    Mr. DOGGETT. Thank you very much.
    Dr. Orszag, you talked about the regional differences that 
exist. How do you take the comparative effectiveness 
information and disseminate it in a way to reduce those 
regional variations?
    Mr. ORSZAG. Well, the first step is to develop the 
information because a lot of that variation is arising in 
situations where there is no evidence on what works and what 
doesn't. Therefore, doctor norms in different parts of the 
country take hold which are not based on scientific evidence 
and therefore don't translate into improvements in life 
expectancy or other metrics of health quality even though they 
cost more. So, the first thing is the provision of the 
information.
    As I think most of the written testimony emphasized, 
whatever entity is designed to do this or expanded to do this 
kind of research would have to pay a lot of attention to the 
dissemination of the information to health professionals. 
Having a more developed HIT backbone, health information 
technology backbone, could facilitate that.
    Then finally, to the extent that the information is 
ultimately incorporated into financial incentives for providers 
or for patients, that is a very direct way of signaling 
information.
    Mr. DOGGETT. I was interested also in the graph that you 
had because it is so dramatic. Do you have it broken down into 
a percentage as to how muchif you assume that health care costs 
to Medicare continue rising at the current rate, how much is 
attributed to just an increase in the population of aged 
beneficiaries and how much of it is related to rising cost?
    Mr. ORSZAG. Yes. In fact, on that first chart, the bottom 
dotted line is precisely what you identified, the demographic 
effect. So, there are more beneficiaries, and they are getting 
older, and that drives up cost. But that cost increase is 
pretty modest, and if I added Social Security to the curve, it 
would be a little bit more.
    It is much, much smaller than how much is driven by the 
rate at which health care costs grow compared to income per 
capita. I think we have woefully under-invested in options that 
could help bend that curve, which is the central long-term 
fiscal challenge facing the country.
    Mr. DOGGETT. Thank you all.
    Chairman STARK. Mr. Ramstad?
    Mr. RAMSTAD. Thank you, Mr. Chairman. I want to thank all 
three of you true experts for your testimony.
    Dr. Orszag, I have a question. My overriding concern here, 
and it is really quite compelling, I believe, is that this new 
standard or model, the comparative effectiveness analysis, call 
it what you will, that it could end up denying patients 
lifesaving medical technology, appropriate medical technology.
    I have seen the empirical data, and they all suggest, at 
least the studies I have seen, that medical technology saves 
dollars in the aggregate rather than costing dollars. Some 
policy-makers don't understand that, I realize. But anyway, 
that is not my question, but I think it needs to be taken into 
account.
    My question is this: How would we ensure under this new 
paradigm, if you willhow would we ensure that complex study 
results, such as evaluation of a surgical procedure versus a 
medical therapy, be properly conducted and analyzed? What would 
be the mechanism to ensure such a quality study?
    Mr. ORSZAG. Well, a few comments. First, I think the 
institutional design of the entity or entities that were 
charged with conducting this kind of analysis would have to 
include standards for how the research would be conducted.
    So, for example, that the researchers not have financial 
ties to the companies that might be producing certain things; 
that the statistical techniques usedand I want to pause on that 
for a second because I do think if we are going to 
significantly expand this kind of research, it is not likely 
that we will be able to rely solely on randomized trials.
    So, the expanded use of statistical analysis of health 
records, basically, will be necessary. Having a dramatically 
expanded system of electronic health records would facilitate 
the kind of rigorous studies that could provide detailed 
analysis of sub-populations in a way that we currently only 
have a limited ability to do.
    Mr. RAMSTAD. So, you think it would be better able to 
consider highly nuanced situations across sub-populations?
    Mr. ORSZAG. With an expanded electronic health record 
backbone, there would be a much greater ability to study sub-
populations, yes.
    Mr. RAMSTAD. Dr. Clancy, I see you shaking your head 
affirmatively. Would you care to comment?
    Dr. CLANCY. Yes. I would just like to reinforce that. Our 
2008 budget request includes a request for $15 million, with 
which we will be launching a partnership with private sector 
health care organizations that have made the investments in 
electronic health records so that we can actually, in effect, 
work with them to create a distributed network both to do the 
kind of work that Dr. Orszag just described, but also to make 
sure that those organizations can use the findings as rapidly 
as possible, which is, I think, a point here that I don't want 
us ever to lose.
    Dr. MILLER. If I could just----
    Mr. RAMSTAD. Please, Dr. Miller.
    Dr. MILLER [continuing]. I mean, one other part of the 
structure is to be sure that the results are open to public 
review and comment, much like you have in an academic process, 
so that other researchers and other analysts and other parties 
can comment on the work.
    Mr. RAMSTAD. Of course, there would be a mechanism for the 
dissemination to all concerned parties, patients, as well as 
providers, practitioners.
    Let me ask you a final question, if I may, Dr. Miller. One 
of the things I have learned over the years is the 
effectiveness of a medical device often depends on the skill of 
the physician using the device. Certainly physicians have to 
learn how to best use the device, determine which patients are 
the appropriate candidates for treatment, and so forth.
    How can we make sure that the comparative effectiveness 
device is assessed in the context of physicians developing the 
skills to use that particular device?
    Dr. MILLER. Well, I think a lot of this research tries to 
see how the given intervention works in a real world setting. 
So, part of the research can actually address the skills that 
are needed toif it happens to be a device or a particular 
procedure. Some of that can be built into the study itself. The 
idea here is real world use of the intervention.
    Mr. RAMSTAD. So, we are not going to determine comparative 
effectiveness before doctors develop the skills to use whatever 
device?
    Dr. MILLER. When you have a controlled trial, you are 
actually doing the procedure or testing the drug itself. Some 
of what you would need would come out of that process.
    Mr. RAMSTAD. Well, thank you. My time is up. I appreciate 
your responses.
    Thank you, Mr. Chairman.
    Chairman STARK. Mr. Pomeroy, would you like to inquire?
    Mr. POMEROY. I sure would, Mr. Chairman. Thank you.
    I want to especially congratulate Dr. Orszag for his 
testimony. He couldn't have laid it out more clearly. We are 
heading to a financial train wreck. Health spending is the 
driver, the largest single driver of this fiscal train wreck 
ahead, and that if you look at it, we are seeing money pour out 
of the Treasury in differing ways across the country, ways that 
don't seem to be getting us anything in terms of health care 
return.
    So, getting to the bottom of that one, you just couldn't 
have laid that out more clearly for us. I wouldn't think there 
would be any bipartisan disagreement across this panel. We have 
got to get to the bottom of that. Data and the analysis of it, 
capturing outcome data, procedural data, trying to get our 
hands around it, is a way to do it.
    We have been talking about this, however, since I was 
insurance commissioner. I remember this coming up in the late 
eighties, early 19nineties. I thought, ah-hah, this is really 
going to advance the practice of medicine in this country. Man, 
we have just gotten almost nowhere. I am a littlewell, anyway, 
we have to get it right away.
    Now, I have heard from some associations that essentially 
the procedure for data collection and outcome analysis launched 
by legislation we passed is not built on a collaborative basis 
at all and doesn't haveit is not going to work very well. Dr. 
Clancy, can you reflect on those concerns?
    Dr. CLANCY. I am not sure which legislation that you are 
referring to. I am pleased with the collaborations that we have 
had to date, but I would be happy to follow up on specific 
concerns that you have been hearing.
    Mr. POMEROY. Did Committee on Ways and Means toward the 
second half of last year do something about data?
    Dr. CLANCY. You may be talking about physicians reporting 
on quality.
    Mr. POMEROY. Yes.
    Dr. CLANCY. Yes.
    Mr. POMEROY. That would be an essential component of this 
effort, wouldn't it?
    Dr. CLANCY. No. It is a little bit separate. Where 
physicians might be involved
    Mr. POMEROY. But equality data will illustrate what you are 
paying for that is providing value versus what you are paying 
for that is not providing value in terms of expanded health 
outcomes. Correct?
    Dr. CLANCY. What the quality data is looking at right now 
are those areas, just a few, where we are pretty sure what the 
right thing to do is. For example, diabetics should have a 
certain type of test done, surgeons should be doing something 
to minimize the occurrence of infections after surgery, and so 
forth. It is a very small subset of samples.
    I think where many physicians are feeling frustrated right 
now, particularly those in small practices, is that it feels 
like a burden and not much value added. That is a concern we 
take very seriously. It is a bit peripheral to our topic of 
conversation today.
    At the same time that they are not really loving that 
quality reporting, a number have been coming to us saying, we 
want to create our own registries. Some have done that. The 
Society of Thoracic Surgeons is probably the best example.
    But the orthopedists, the College of Surgeons, and many 
others, the bariatric surgeons, all want to collect information 
so that they can get at some of the questions that your 
colleague was asking Dr. Orszag about, about physician skill, 
about potential harms, and how people do over time. We are very 
much looking forward to working with them on that.
    Mr. POMEROY. It strikes me that as clear as this is 
conceptually, getting into it is quite difficult, thenwho works 
it up, what is measured, how you measure it. Dr. Miller, I do 
see the quality tying directly into this whole effort at trying 
to evaluate what is unnecessary to pay for and trying to get at 
disparate practice patterns across the country, with an eye on 
cost savings.
    What is MedPAC's response to what passed late last year 
relative to quality reporting?
    Dr. MILLER. I think again we are talking about two slightly 
different issues. But just toI do think I understand where you 
are going. Just to address your issue, one tack that we took 
when we were talking through the collection of quality data for 
physician services is we think that a lot of information can be 
collected from the claim stream.
    So, for example, if a physician ought to be, for a 
diabetic, ordering certain types of tests or having eye exams 
or foot exams, that type of thing, some of that information, 
whether it occurred because they are billing for it, can be 
collected through the claim stream without a significant burden 
on the physician themselves.
    Now, I want to be clear. This is not to say that we don't 
think there may be information that should come from the 
physician themselves. For example, we talked about the notion 
of physician offices reporting on their functionality. Do they 
have the ability to do a patient register? Do they do those 
types of things? But there is a lot of information that can be 
collected from the claim stream without putting a burden on the 
physician.
    Now, just one last point. The connection here is if we have 
comparative effectiveness information through analysis, 
clinical trials, that type of thing, that can tell you which 
measures you might want to be collecting from physicians.
    Mr. POMEROY. Thank you. Thanks, Mr. Chairman.
    Chairman STARK. Mr. Becerra.
    Mr. BECERRA. Thank you, Mr. Chairman. Thank you to the 
three of you for your testimony.
    Dr. Clancy, I may make a mistake here, and forgive me if I 
do. But I believe you know my wife fairly well, Dr. Carolina 
Reyes.
    Dr. CLANCY. I certainly do.
    Mr. BECERRA. I know that if she knew that you were here 
today, she would want me to pass along a hello because I know 
she always speaks so very highly of you.
    Dr. CLANCY. Thank you. Likewise.
    Mr. BECERRA. Thank you. Dr. Miller, MedPAC and others have 
said we need to do more when it comes to figuring out how to 
best compare different services, devices, and all the rest to 
cut back on the costs of health care. MedPAC is probably going 
to issue a report that says that we need to do more on 
comparative effectiveness to get better results. Right?
    Dr. MILLER. On Friday.
    Mr. BECERRA. Okay. Dr. Orszag, I think you have talked 
about, as Mr. Pomeroy said, this looming crisis in our 
budgeting and how health care is such a big part of it. I think 
most people would agree that if we do a good job with this 
comparative effectiveness, we are going to save some money.
    But I don't believe that you are prepared or we are 
prepared to see, coming out of those who do the analysis of how 
this affects dollars, you are going to come out and say, this 
scores well and has a big savings for us, at least not at this 
stage.
    Dr. ORSZAG. What I would say is this holds substantial 
potential to reduce costs over the long term if it is 
implemented aggressively. Savings over the next decade is a lot 
harder because you have to get this thing up and running, you 
have got to do the studies, and then you have got to get it 
implemented.
    So, if you are looking at bending the curve over the long 
term, there might be a material effect. If you are looking for 
cost savings over the next 10 years, that is a much harder 
thing.
    Mr. BECERRA. If we had a bill that would provide a chunk of 
money so that Dr. Clancy could do more research, how would you 
score it?
    Dr. MILLER. Over the next 10 years or over
    Mr. BECERRA. Ten years is our horizon.
    Dr. ORSZAG. Yes. Over the next 10 years, again, I would not 
be expecting any significant cost savings over that period.
    Mr. BECERRA. So, Dr. Clancy, now I come to you. I believe 
you have about $15 million or so to try to do some of this 
research. You were authorized to get up to 50 million, but you 
got 15 through the appropriations process, far less than what 
you were authorized to get, far less than you probably needed 
to be authorized to get, but you have 15 million.
    If we were to go legislation in this PAY-GO world where we 
have to pay for everything that we propose that is new 
spending, we are going to have a tough time figuring out how to 
get you the dollars you need to do the research we need so we 
can start saving the money that everyone acknowledges that we 
can gain from this.
    So, it seems like we are in this awful dilemma, this Catch-
22, where we know that there are savings. We know long term 
they will be there. But for our purposes, we can't score them 
as savings, and as a result you get these meager allocations of 
money through the appropriations process, which never leaves 
you enough time and resources to do the research that will 
prove what we say we know.
    So, I am wondering if you can help us out of this quicksand 
and tell us, how can we persuade our colleagues that we must do 
much more than just provide $15 million in research dollars so 
you can do the work to prove the effectiveness of this?
    Dr. CLANCY. Well, first of all, that is a great question. 
Thank you very much. The MMA, Section 1013, I think only had a 
limit for the first year. You are right that it took the 
appropriations another year to catch up.
    I do think that we have heard considerable private sector 
interest in being part of a serious public/private 
collaboration, and I think that is a good thing, with all the 
caveats about minimizing conflicts and so forth. I think that 
may be part of the answer.
    Ultimately, I think the answer is going to be in the return 
on investments. I think that we are beginning to make a 
downpayment now. We will actually let a contract in the next 
few weeks to see the extent to which we can take advantage of 
all the investments that organizations have made in electronic 
health records to create network where we can learn much 
faster.
    Beyond that, if Dr. Orszag can't help you out, I have to 
say I would defer to his expertise.
    Mr. BECERRA. You mentioned the private sector funding. 
Obviously, the folks in the private sector have a massive 
interest in this as well. My concern is, as we said before, we 
need these firewalls to make sure that the influence doesn't 
drive us in the wrong direction.
    You believe that we could create those firewalls, that the 
tendencies wouldn't be to try to direct the research in ways 
that benefit those from the private sector who are providing 
the resources?
    Dr. CLANCY. I think with this public/private partnership, 
we will have a terrific opportunity to begin to test that. We 
are going to start off with issues that no single health care 
system is big enough to address on its own. We are actually 
going to be examining the impact of breakthrough treatments, 
sometimes referred to as personalized health care, to find out 
how rapidly those treatments are diffused. Do they have the 
impact that is expected that we see in the laboratory? What 
happens to them when they are used off-label, and so forth.
    I think that might be one framework to begin. I think the 
concern is this private sector interests are coming up to say, 
I like this study, and I will contribute here but not over 
here. I think a robust framework that addresses the issues you 
raised would need to mitigate that concern.
    Mr. BECERRA. Thank you. Thank you, Mr. Chairman.
    Chairman STARK. Mr. Kind, would you like to inquire?
    Mr. KIND. Great. Thank you, Mr. Chairman. I want to thank 
our guests here today, too, for your testimony and your help 
and your recommendations and guidance on this issue.
    We in Wisconsin have been very fortunate and quite 
delighted with the whole collaboration for health care quality 
that has been assembled between our providers. It is a 
volunteer basis, but they are establishing standards, reporting 
requirements, transparency. It appears to be really paying 
great dividends now, especially in light of a recent report 
issued by the Federal Agency for Healthcare Research and 
Quality ranking Wisconsin hospitals number one in this 
endeavor. We appreciate that recognition.
    But of course, Wisconsin too is one of the lower reimbursed 
states in the nation when it comes to the Federal programs and 
Medicare reimbursement rates. So, there is a great interest and 
drive for outcomes-based or performance--based measures and 
standards which will drive these reimbursements.
    But to me, it seems the key is making sure that we have got 
a totally integrated health information technology system out 
there. Governor Doyle just announced a statewide project for 
all of our providers. But how we get there and how soon we get 
there is going to be crucial.
    As far as establishing the standards, the measurements, the 
effectiveness, which would then drive reimbursements and best 
practices throughout the country, my question is: Can we get 
there without mandating it, without the threat of no Medicare 
reimbursements unless you have HIT fully in place?
    But if we can do it through an incentive basis, what is the 
best incentives to provide? Because this is expensive, and 
right now there is very little financial incentive for some 
providers to do it. A lot of providers are, but there is 
proprietary interest being built up now with the systems that 
they are using.
    The question is, can we integrate that across the bod? What 
type of incentives should we be looking at to help drive the 
whole HIT movement throughout the country so we can establish 
these standards and measurements and start doing some real 
comparison across the board?
    So, we be looking at accelerated depreciation for these 
hospitals who are implementing these systems, or to the 
providers of these HIT systems through the Tax Code? Should 
there be grants offered to hospitals for training purposes for 
implementing HIT technology? Should we be looking at grants for 
lean or Six Sigma programs with our health care providers, too, 
to go after the low-hanging fruit? Dr. Miller?
    Dr. MILLER. Yes. The Commission looked at this issue a 
couple of years ago. It didn't rule out things like the grants 
and trying to put money on the table to bring people together 
in a community. But I think the feeling of the Commission was 
the first and strongest signal, and I think there has been some 
reference to this elsewhere to start to build it into the 
payment system.
    For example, does a physician's office have the capability 
to have patient registries? Does it have prompts to say that 
for my diabetics, I need to do this next test? You wouldn't 
say, I am paying you to purchase this software, but it would 
say, your payments will be increased if you have this 
capability, and then let the market work in behind it to say 
what is the best way to get that capability.
    Then you change the return on investment ratio that right 
now, a physician's office will look at it and say, I have a lot 
of expenditures but I am not sure what I am getting back. If 
you can change that ratio, you can change the incentive. Then 
we made recommendations for hospitals and managed care plans, 
et cetera.
    The point was that the first signal should be through the 
payment system to say, if you have these capabilities or these 
measures, your payments will increase from----
    Mr. KIND. This would be on a temporary basis, I assume. 
Otherwise we are paying more money to try to make providers 
more efficient and more outcomes-oriented.
    Dr. MILLER [continuing]. No. The Commission's view was that 
paying for these kinds of outcomes should be something that 
would be an ongoing basis so that we don't payand I think this 
was a statement made early onwe don't pay the same to each 
provider. We pay more to the providers who have better quality 
outcomes, greater capabilities to track their patients. This 
would be on an ongoing basis.
    Then they did talk about some of those other things that 
you talked about. But I think their feeling was, first let's 
get Medicare to drive this signal pretty hard through its 
payment system.
    Mr. KIND. All right. Dr. Clancy?
    Dr. CLANCY. Yes. First let me just say we work closely with 
the Wisconsin Collaborative for Healthcare Quality, and they 
are terrific. So, I just wanted to let you know that.
    Mr. KIND. Good.
    Dr. CLANCY. Second, we have been supporting a grants 
program of close to $200 for the past several years, evaluating 
the impact of selected applications of health information 
technology on improving quality and safety, with a special 
focus on those providers in rural and underserved areas. We 
also support these health information exchange projects, 
similar to what Governor Doyle would like in six states right 
at the moment.
    So, we have a resource center that I think can give a lot 
of lessons to providers. Having said that, I think we do keep 
coming up against the issue of what is the incentive to adopt 
and what is going to make it worthwhile. It is an issue we are 
pushing on very hard right now in the Department.
    As we speak, the American health information community is 
meeting today. You are likely to see a demonstration coming out 
of CMS in the near future. There are a number of demonstrations 
ongoing now that I think get right at this incentives issue.
    The issue I am working on very specifically, and we 
recently heard from the collaborative, which was great, is how 
can we make sure that certified electronic health records in 
the very near future include the functionality to report on 
quality.
    Right now, providers who have made that investment have 
sometimes been disappointed after they made a big investment 
only to find out that there is no way to just hit the F7 key; 
for example, up go the quality measures. But that problem will 
get solved over the next year or so, and it will include the 
reminders. We don't want to get better at driving by figuring 
out how to drive faster through the rear view mirror. We need 
to do the right thing to begin with.
    Mr. KIND. Great. Thank you. Thank you, Mr. Chairman.
    Chairman STARK. Mr. English, would you inquire?
    Mr. ENGLISH. Thank you, Mr. Chairman, and thank you for the 
opportunity.
    I was intrigued by one of Mr. Ramstad's remarks to Dr. 
Orszag, and I guess I would like to reframe it as a question to 
Dr. Clancy. Specifically, how will you update the comparative 
effect of this measure to be reasonably sure that you are not 
dampening the innovation in patient treatment and medical 
devices that is occurring today?
    If a plan, for example, limits access or bases coverage on 
formulas derived from comparative effectiveness studies, how 
does the plan avoid penalizing doctors who are on the cutting 
edge and who are trying new surgical techniques or new 
interventions to help their patient?
    Dr. CLANCY. Thank you. That is a concern that many people 
have. We are committed to updating our reports to reflect the 
latest changes in science. We recognize in particular that for 
devices, this is a particularly unique challenge because they 
are constantly being updated.
    This is an area where clinical trials are unlikely to be 
the answer to that particular question. In fact, we think it is 
very consistent with the kind of observational studies we are 
funding right now through a network that we call DEcIDE, and 
would be very interested in additional input on this question.
    Because as these devices get better and as we learn more 
and can collect information about which patients benefit and 
under what circumstances, we will all be better off. Again, we 
think that transparency throughout the process, from setting 
the agenda to framing the questions to reviewing the reports 
and so forth, is the greatest protection against information 
being used in a way that is contrary to patients' interests.
    Mr. ENGLISH. Doctor, I think that is a good answer. I guess 
my concern would continue to be a process one, that simply how 
can you as a government entity stay on top of this in realtime 
and stay on top of current practice? But that is something that 
I will monitor and welcome the opportunity to engage with you 
on.
    Dr. Miller, right now clearly there are significant gaps 
between what we know based on current science and evidence and 
what actually gets implemented into everyday clinical practice. 
In your view, shouldn't we be doing more research to get at the 
best approaches to closing some of those gaps?
    Dr. MILLER. If I understand the question, the answer is 
yes. That is a lot of what we were talking about today and will 
be discussed in the report that is going to come out on Friday. 
But maybe I didn't quite understand.
    Can I say one thing about?----
    Mr. ENGLISH. Go ahead.
    Dr. MILLER [continuing]. You asked about the stifling of 
innovation.
    Mr. ENGLISH. Yes.
    Dr. MILLER. I think one thing that all of us should keep in 
mind is that innovation investment is occurring now, and it is 
doing that on the basis of a very fragmented information basis, 
and in some cases information that is not completely unbiased.
    I think one of our arguments here is that if we want a 
market to work well, we shouldn't be afraid of complete 
information. I think your concern about being sure that we are 
on top of it is well taken. But right now the information is 
very fragmented and incomplete, but driving lots of investment 
and lots of dollars.
    Mr. ENGLISH. Well said. I will yield back the balance of my 
time.
    Chairman STARK. Thank you. Ms. Schwartz, would you like to 
inquire?
    Ms. SCHWARTZ. Thank you, Mr. Chairman. Thank you for the 
opportunity.
    I guess I should say that there are two particular reasons 
why I am here, and I think I am looking at Dr. Clancy because 
my understanding is that you do a pretty good job of what you 
do. Having one of the evidence-based practice centers13 of them 
having one of them in my district, and I have visited with them 
and asked people in the community or providers and payors, and 
tremendous respect for the information that comes out of ECRI, 
which is in Plymouth Meeting, Pennsylvania. I think they do a 
good job, and your shop as well.
    So, I think you have already answered the question that has 
been asked, which seems like a reasonable one, is why create a 
new system to do this when we already have one that is really a 
public/private partnership in a way already? Because there are 
these eleven, in some cases private, in my case, I assume they 
all are evidence-based research institutes that actually do 
this work on your behalf and helps you do all the work that you 
do.
    Is that not true, that there is a mechanism in place now, 
and as was pointed out before, if you actually just do more of 
what you are doing, again with the right priorities, that you 
could have more of an effect in controlling some of the cost, 
or at least providing information to the providers and to the 
usually hospitals and doctors to know that they are using the 
most effective treatments and devices?
    Dr. CLANCY. The vast majority of the investments we make in 
this program are indeed to private sector entities. Some are at 
academic medical centers. Some, like ECRI, are freestanding 
independent institutes or like Blue Cross Blue Shield Tech 
Association and so forth.
    So, yes, I would say that this is very much a public/
private partnership. Thank you for your comments on ECRI. They 
are also very, very interested in this issue and making 
contributions.
    Ms. SCHWARTZ. I know that they would be happy to do more if 
they the funding to do that. I hope to be a part of this.
    Do you have any evidence yet about when you do do a 
comparative study and get that information out, that you have 
even anecdotal information coming back, sayingfrom hospitals or 
physician practices that they have changed their behavior 
because of information you have put out?
    Because that is the point, I think, that Dr. Orszag made, 
is that we need to have some sense that it is being used in the 
real world of health care. Someone is taking that action, 
saying I used to use this treatment because I always did, and I 
am not up on the evidence but your information actually made a 
difference. Or, in fact, I was buying the cheapest thing out 
there, and your information has actually helped me buy 
something else because it is more effective.
    Dr. CLANCY. We have information that a variety of 
organizations have been very, very enthused about this 
information. Much of it is anecdotal and more like case 
studies. We work very closely with the College of Physicians 
that you will be hearing from, from a variety of consumer 
groups. Consumer Reports takes advantage of information that is 
produced by another one of the evidence-based practice centers, 
and so forth.
    I think it would probably be more helpful if I could get 
you a thoughtful written response to that question.
    Ms. SCHWARTZ. I think it would be helpful to the Committee, 
in particular as we move forward, to make sure that it is being 
used, and it is being used in a timely fashion and, of course, 
kept up to date.
    My other than question may actually be for Dr. Orszag more. 
That is: You suggested that because of the regional 
differences, that the I assume doctors and hospitals are not 
using evidence-based information as they make their decisions. 
What do you think they are making their decisions on?
    Mr. ORSZAG. A lot of the variation seems to occur where 
there simply is no evidence. So, I will give you an example. 
You fracture your hip. You go in for surgery. The variation in 
surgery costs for hip fractures is very small across the United 
States.
    For the follow-up costs of that hip fracture surgery, there 
is no evidence on whether you should go see your doctor four 
times a month or twice a month. Should you get an MRI or not? 
Should you do physical therapy or not? There is just no 
evidence.
    For the follow-up costs of the hip fracture surgery, there 
is a lot of variation. I think what happens is in some parts of 
the country, the doctors have been trained in a particular way 
or believe that a certain thing works without any scientific 
evidence behind that. That is what happens.
    Ms. SCHWARTZ. So, the standard of practice is just 
different, in a way?
    Mr. ORSZAG. The doctor norms differ. That is why you see 
this variation even within relatively small geographic areas, 
where different doctor groups are practicing in different ways.
    Ms. SCHWARTZ. Do you think cost comes into this, that 
peopleare you suggesting that even the decision about what 
device you might buy, that cost comes into that as much as 
information about how effective it is? Is it cost? Is it 
availability? Is it who comes to the hospital and sells it? 
That is what I was wondering about, too. Is it based on just 
access to the information?
    Mr. ORSZAG. Our payment----
    Ms. SCHWARTZ. Which then speaks to how do we get at the 
good information broadly enough so that that actually is 
available in helping to make these conditions?
    Mr. ORSZAG [continuing]. Our payment system seems to 
accommodate or facilitate these variations in doctor norms 
because especially within Medicare, we basically provide, we 
pay for, whatever doctors order, to a first approximation. So, 
if in one area doctors practice in a certain way, they get paid 
for that, and if in another area they practice in a more cost-
effective way, they get paidthe payments reflect that.
    So, the payment system is playing a role, and it is 
accommodating this variation in doctor norms.
    Ms. SCHWARTZ. All right. Dr. Clancy, did you want to 
comment on that at all?
    Dr. CLANCY. I think the availability of facilities and 
providers in a particular area often has a lot to do with, say, 
the follow-up costs or other examples of variation. So, for 
example, if there are few physical therapies in an area, 
doctors are going to order less of it, as compared with a 
community where there are a lot of terrific physical 
therapists, and so forth.
    When you look at different providers and how they are 
distributed across the country, it kind of makes you scratch 
your head. But that clearly, I think, does have an impact on 
norms as well.
    Ms. SCHWARTZ. All right. Thank you for your indulgence, Mr. 
Chairman.
    Chairman STARK. Thank you. Do any of the Members have any 
other burning issues? Before I thank the panel for your 
patience and your efforts in helping us wind our way through 
this process. Thank you very much.
    Our next panel will be led of by Dr. Gail Wilensky, who is 
a Senior Fellow at Project Hope, formerly a director of CMS.
    Dr. David Dale, who is president of the American College of 
Physicians.
    Ms. Gail Shearer, who is the Director of Health Policy 
Analysis for Consumers Union.
    Dr. Susan Hearn, who is the Senior Project Manager in 
Environmental Health and Safety at the Dow Chemical Company of 
Midland, Michigan.
    Dr. Steve Teutsch, who is the Executive Director of 
Outcomes Research and Management for the Office of Scientific 
and External Affairs at Merck and Company of West Point, 
Pennsylvania.
    Welcome the panelists. Without objection, your testimony 
will appear in the record in its entirety. We would ask you to 
summarize for us or add to it in any way that you are 
comfortable.
    Gail, do you want to lead off? You have to turn your mike 
on.

STATEMENT OF GAIL WILENSKY, Ph.D., SENIOR FELLOW, PROJECT HOPE, 
                       BETHESDA, MARYLAND

    Ms. WILENSKY. I should know that by now. Thank you, Mr. 
Chairman and Members of the Subcommittee. It is a pleasure to 
be here. The comments I am going to be making reflect my 
training as an economist, my experience at HCFA and MedPAC, and 
also my membership on a Committee established by Academy Health 
to look at the issue of placement, structure, and financing of 
comparative effectiveness research. But my comments here 
reflect my personal views and not those of these organizations.
    I have included in my testimony an article that was 
published online in Health Affairs late last year that lays out 
my thinking on some of the fundamental issues regarding 
placement financing and functions. This has been a very topical 
subject, and the comments today reflect some of the evolution 
in my thinking since then.
    The rationale for such a center, I think, has been stated 
well. We have an unsustainable rate of spending growth, and we 
have that in a world where there is clear and persistent 
indications of problems with both patient safety and with 
quality.
    To be sure, better information will not by itself be enough 
to moderate spendingyou have heard that from several people 
beforeand maybe not even enough to alter practice behavior. 
Changing the incentive structure that faces patients and 
clinicians, using comparative clinical effectiveness 
information along with cost data to set reimbursement rates, 
and a whole myriad of other changes will be needed. the other 
hand, without better information on what works when, for whom, 
provided under what circumstances, it is hard to imagine how 
the U.S. will learn how to spend smarter.
    I have been advocating for a center that would have an 
information function rather than a decisionmaking function as 
it would pertain both to coverage decisions and reimbursement 
decisions, although I primarily see the information in such a 
center as informing better clinical decisionmaking and helping 
in the design of smarter decisions regarding reimbursement, as 
opposed to setting any additional criteria for coverage. These 
are different and fundamental roles compared to some of the 
centers that exist in other parts of the world.
    I believe that the function for such a center should be to 
fund new research, synthesize existing research, and make sure 
that information is available about what is likely to result 
from using different treatment options for different subgroups 
in the population.
    We need to be functioning on medical conditions rather than 
specific interventions or therapeutics; that is, cardiovascular 
disease or orthopedic surgery, and not a particular device. We 
need to be sure medical procedures are being included, and not 
just look at a particular therapeutic or medical device.
    We need to recognize that technologies are rarely always 
effective or never effective, and that the role for a center is 
to inform decisionmaking about the likelihood that a favorable 
outcome will occur. We need to recognize that it is likely that 
the outcomes will differ for different subgroups in the 
population. As was asked in the previous panel, we need to 
understand that this is a dynamic process and not a once done, 
finished forever process.
    I believe that the characteristics of the data help 
determine where the center might best lie. The data needs to be 
regarded as objective, credible, transparent, protected from 
the political process and also from the interest of affected 
parties. It needs to be timely and understandable.
    To me, having looked at the various choices, I believe the 
best combination is a federally funded research and development 
center like the Lawrence Livermore Labs attached to AHRQ, close 
but not too close to government, enough to give it a little 
protection in terms of both the view of the private sector and 
the academic and other communities.
    It is one that would be sponsored by an executive branch 
agency, AHRQ, and make sure that it has a strong tie to AHRQ. I 
think it is important that the center have both intramural, 
that is, in-house research and extramural, that is, contract 
research capability.
    The governance also needs to make sure that it can stand 
the test of credibility, objectivity, and transparency; 
staggered-year appointments by the Executive Branch, maybe 
subject to Senate confirmation, so that no one administration 
has too much control, with specialized scientific boards.
    In terms of funding, I think you can make an argument for 
direct appropriation. But given the realism of the difficulties 
that might present, I think you could also make an argument for 
a contribution from the Medicare trust fund and also one that 
has an assessment on privately covered lives because the payors 
will be the major users.
    Let me summarize, then. I believe such a center would be an 
information center and not a decisionmaking center, providing 
credible information to clinicians, patients, and payors to use 
to make better decisions. I think it would have many important 
purposes, including the development of a reimbursement system 
in which copayments could be tiered to what makes the most 
sense clinically and economically, informed by credible, 
objective, transparent data.
    Different payors can and should make different decisions. 
If Medicare is to be able to make use of this kind of 
information, it will need to have additional authority in 
setting reimbursement rates according to what makes sense for 
various subgroups of the population. I believe the agency would 
be one of the many changes that needs to occur if we are ever 
to learn how to spend smarter on Medicare. Thank you.
    [The prepared statement of Ms. Wilensky follows:]

              Prepared Statement of Gail Wilensky, Ph.D., 
            Senior Fellow, Project Hope, Bethesda, Maryland

    Mr. Chairman and Members of the Subcommittee: Thank you for 
inviting me here to testify on strategies to increase information on 
comparative clinical effectiveness. My name is Gail Wilensky. I am 
currently a senior fellow at Project HOPE, an international health 
foundation that works to make health care available to people around 
the globe. I have previously directed the Medicare and Medicaid 
programs as the Administrator of the Health Care Financing 
Administration and also chaired the Medicare Payment Advisory 
Commission. The views I am presenting here reflect my training as an 
economist, my experience at HCFA and MedPac and also my membership on a 
committee established in by AcademyHealth (the professional society for 
health services research) that considered the placement, structure and 
financing of comparative effectiveness research. My testimony today, 
however, reflects my personal views and not necessarily the views of 
Project HOPE, Academy Health or any other organization.
    I am here today to discuss how to develop information on 
comparative clinical effectiveness (CCE) through the creation of a new 
Center for Comparative Clinical
    Effectiveness. My testimony includes an article I wrote that was 
published on-line in Health Affairs last November which lays out my 
thinking on the fundamental choices regarding the placement, financing 
and functions of such a center. As a result of the many conversations 
that I have had about CCE with potential stakeholders, funders and 
supporters or opponents, my thinking has evolved since the original 
article. My current views are reflected in the following statement.
Rationale:
    In a period when there is little consensus about how to reform 
American health care, there seems to be a developing consensus on the 
need for better information on comparative clinical effectiveness. 
Driving this interest is the recognition that the current rate of 
spending growth in health care (a long term average 2\1/2\% annual 
growth rate in health care faster than the economy) is simply not 
sustainable and that even with this spending growth, there are clear 
and persistent indications of problems with patient safety and with 
quality.
    To be sure, better information will not by itself be enough to 
moderate spending and maybe not even enough to alter practice behavior. 
Changing the incentive structure that faces patients and clinicians, 
using comparative clinical effectiveness information along with cost 
data to set reimbursement rates and a whole myriad of other changes 
will also be needed. On the other hand, without better information on 
what works when, for whom, and provided under what circumstances, it is 
hard to imagine how the U.S. will be able to develop strategies that 
will allow the country to learn to spend ``smarter'' and without this, 
it is hard to imagine how we will lower the longer-term ``excess'' 
spending growth rate.
Role of the Center:
    The interest in comparative clinical effectiveness information is 
neither new nor is it limited to the U.S. Other countries, however, 
have tended to focus their analyses primarily on pharmaceuticals and 
devices and their assessments tend to be an important or required 
element in coverage or reimbursement decisions for their national 
health systems.
    I am advocating for a Center for Comparative Clinical Effectiveness 
that would have a different focus and serve an information function 
rather than a decision-making function--both as it may pertain to 
coverage or reimbursement decisions. Further, I am assuming that the 
information would primarily inform better clinical decision-making and 
help in the design of smarter decisions regarding reimbursement as 
opposed to setting new requirements for coverage. These are fundamental 
and critical differences in roles.
    The purpose of the Center on CCE is to fund new research, 
synthesize existing research, disseminate and otherwise make available 
what is known about the likely clinical results of using different 
treatment options for different subgroups of the population. The focus 
therefore is on medical conditions rather than on specific 
interventions or therapeutics and needs to include medical procedures 
rather than only be limited to pharmaceuticals and devices. It also 
recognizes that technologies are rarely always effective or never 
effective (assuming that some time of approval process is required such 
as the FDA) and that the role of the center is to help inform various 
decision-makers about the probability that a favorable outcome will 
occur. Thus, comparative clinical effectiveness not only provides 
information that is comparative across various interventions but also 
recognizes that the outcomes may differ substantially for various 
subgroups of the population. Because of the nature of the discovery 
process and incremental changes that occur over time, it is important 
to recognize that investment in CCE needs to be thought of as a dynamic 
process and not once-done, finished forever.
Placement of the Center:
    Over the past several months, there has already been a lot of 
discussion about where such a center should be placed and what kind of 
data should be included. In thinking about these issues, it is 
important to think about the characteristics that the information 
itself must possess if it is to serve the function envisioned for such 
a center. The most important are for the data to be regarded as 
objective, credible, and transparent--protected from both the political 
process as well as the interests of affected parties. The information 
should also be timely, span the full range of data available and be 
understandable to the various parties who want to make use of the data 
but the most important characteristics are those associated with 
``trust''. Without that, the center won't be able to serve its 
fundamental reason for existing.
    Some have argued the merits of keeping the Center directly within 
government, with many choosing to house it in the Agency for Health, 
Research and Quality, AHRQ, the place where the Medicare Modernization 
Act directed a limited amount of comparative clinical effectiveness 
analysis to occur. Others have argued the merits of keeping it outside 
of a direct involvement with government. While any placement will have 
its advantages and disadvantages, on balance the one that is most 
appealing to me is the use of a Federally Funded Research and 
Development Center, FFRDC, which is attached to AHRQ. These are 
entities that are primarily funded by government (minimum of 70%) and 
are sponsored by an executive-branch agency, which monitors its use of 
funds. There are several that have been around for many years. The 
Lawrence Livermore Labs is one of the larger, better known FFRDC's. 
This model best reflects the dictum of ``close . . . but not too close 
to government'' and also assures a close linkage with AHRQ, the lead 
agency for health services research which needs importantly to continue 
in that role. I also think the Center would be most effective if it had 
both intramural (in-house research) and extramural (contract research) 
functions as do both AHRQ and the NIH. The in-house researchers provide 
an important element of expertise and hands-on experience but my 
assumption is that much of the work would be contracted out to 
universities, free-standing research groups, etc.

Governance:
    The governance of such a center is almost as important as its 
placement. Again, the key concepts are credibility, objectivity and 
transparency. This means a governing body that is reflective of all the 
major stakeholders, with staggered year appointments by the executive 
branch (and maybe subject to Senate confirmation) so that no one 
administration has too much control. Specialized scientific advisory 
boards would presumably be created for advice on particular comparative 
effectiveness studies, particularly those involving new research.

Funding:
    Like any new entity, a Center for Comparative Effectiveness would 
require several years to reach a ``steady-state'' which I have assumed 
would be several billions of dollars. Because information is clearly a 
``public good'' as the economist uses the term, my preferred funding 
would be by direct appropriation, as is the funding for the NIH. That, 
however, may not be a realistic strategy. Another option is to combine 
funding sources that include monies from direct appropriations, a 
contribution from the Medicare trust fund and a small assessment on all 
privately covered lives. Although all will benefit from the 
availability of such information, thus the rationale for a direct 
appropriation, the payers will be especially advantaged by having this 
information available.

The Role of Costs:
    The most controversial issue to date has been whether or not to 
include cost-effectiveness or cost-benefit analysis directly in a 
Center for Comparative Clinical Effectiveness. While I firmly believe 
the data made available by the Center should be used by payers in doing 
cost-effectiveness and cost benefit analyses and that funding to CMS 
should be made explicitly for this purpose, along with the ability of 
the agency to use such elements in their reimbursement decisions, I 
believe it is best to keep these functions housed separately. Payers 
would be wise to have their 
C/E and C/B analyses subject to the same criteria of credibility and 
transparency that are so critical to the acceptance of comparative 
clinical effectiveness information. This will be key to their 
acceptance and credibility although my expectation is that different 
payers would use the information differently in designing their 
reimbursement policies.
    My rationale for the separation is two fold. One reason is 
technical. The concepts and decisions involved with C/E and C/B 
analysis are more controversial and subject to dispute: where in the 
life cycle is the technology and how much does that affect costs, whose 
costs are being measured--Medicare, small purchasers, large purchasers, 
etc, what functions are or are not absorbed by the purchaser, i.e. is 
the purchaser wholesale or retail, etc. In part because of these 
technical issues but also because of the more controversial nature of 
the implications of cost analyses, including the perceived threat that 
could result from these analyses, I believe combining the inclusion of 
cost analyses, particularly early on, will increase the political 
vulnerability of a center for comparative political effectiveness and 
since such information is the most elemental building block to learning 
how to spend smarter, it needs to be protected.
    Finally, to reiterate, the Center for Comparative Clinical 
Effectiveness would be an information center, not a decision-making 
center, providing credible information for clinicians, patients and 
payers to use to make better decisions. Such information would have 
many important purposes including the development of a reimbursement 
system in which co-payments could be tiered to what makes the most 
sense clinically and economically, informed by credible, objective 
transparent data. Patients and clinicians that want more or want to 
choose differently should be able to do so but should need to pay more 
for their choices. Medicare does not currently have such authority in 
setting reimbursement rates and granting the agency this authority 
would be one of the many changes that would need to occur in learning 
to spend smarter under Medicare.

                                 

    Chairman STARK. Thank you.
    Dr. Dale?

           STATEMENT OF DAVID DALE, M.D., PRESIDENT, 
                 AMERICAN COLLEGE OF PHYSICIANS

    Dr. DALE. Thank you, Chairman Stark, Ranking Member Camp, 
and Members of the Subcommittee for this opportunity for the 
American College of Physicians to testify on comparative 
clinical effectiveness. I am David Dale, president of the 
College and professor of medicine at the University of 
Washington. I will highlight our positions on this issue and 
refer the Members to the written testimony previously 
submitted.
    The College strongly supports congressional efforts to 
provide Medicare and all stakeholders with improved access to 
information about the relative strengths and weaknesses of 
various clinical products, procedures, services, based on the 
best available evidence from clinical effectiveness research.
    From the perspective of a practicing physician, the 
increased availability of sound effectiveness data has direct 
clinical usefulness. For example, I regularly advise men about 
the diagnosis and treatment of prostate cancer and many other 
problems in my general internal medicine practice.
    When a patient, a close friend, recently asked me for 
advice, I tried my best to give him a complete and unbiased 
comparison of the risks and benefits of various treatment 
strategies. But there is really very little comparative data 
available.
    Similarly, women with breast cancer are currently treated 
with a wide range of therapies. We know relatively little about 
their comparative effectiveness, particularly the long-term 
effectiveness and the adverse effects of these therapies. But 
we could know much more through gathering data from current 
clinical practice if we had the mechanisms in place to do so.
    The United States does not currently have a systematic 
means of producing the information to compare the relative 
effectiveness of drugs, durable equipment, therapies, and 
procedures. This is in marked contrast to the organized 
activities in a number of other countries, including Canada, 
Great Britain, Germany, and Australia.
    The College recommends that the Congress take efforts, 
including allocation of secure and sustained funding, to 
support a trusted entity that systematically develops evidence 
on the relatively effectiveness of health care services.
    The College believes that this trusted entity should be an 
unbiased and independent organization; have transparent 
procedures with strong stakeholder involvement, prioritized to 
ensure the evidence produced has the greatest impact; present 
its findings promptly in a way that is accessible and 
comprehensible to all stakeholders.
    The entity in the United States that currently best matches 
this list of characteristics is the Agency for Healthcare 
Research and Quality, AHRQ. The College commends the efforts of 
AHRQ, and has recently urged Congress to increase its level of 
funding in a joint letter signed by the American Medical 
Association and over 80 other medical organizations.
    The College believes that the greatest value of comparative 
effectiveness data is to help answer the question of what works 
best and for whom it works best, given the clinical conditions 
of the patient and the patient's preferences. We believe that 
the primary use of this information right now is for patient-
centered care and counseling.
    Better information will enable physicians and empower 
patients to engage in well-informed shared decisionmaking. 
Shared decisionmaking is a key and essential element for 
improving care through the patient-centered medical home, a 
model of care now supported by provider groups representing 
over 330,000 primary care providers.
    The College is aware of suggestions concerning the 
potential use of comparative effectiveness data by Medicare and 
other payors to redesign their health benefits based on 
reimbursement or patient cost-sharing of comparative evidence 
on effectiveness. The College recognizes the potential savings 
obtained through this approach, but we recommend that Congress 
proceed cautiously. Experience and evidence are required to 
determine the impact of such research on the quality of care 
and patient satisfaction before it is integrated into the 
payment process.
    Finally, the College asks Congress to recognize the value 
of health information technology. Better health information at 
the level of the practicing physician will facilitate the 
collection, reporting, and aggregation of clinical data to 
support evidence-based research on a wide range of important 
clinical problems.
    The pathway for development of comparative efficacy data is 
through implementation of interoperable health information 
technology throughout our health care system. Thank you.
    [The prepared statement of Dr. Dale follows:]

          Prepared Statement of David Dale, M.D., President, 
                     American College of Physicians

    I am David C. Dale, MD, FACP, President of the American College of 
Physicians and professor of medicine at the University of Washington. 
The 123,000 internal medicine physicians and medical student members of 
the American College of Physicians congratulate Chairman Stark and the 
Members of the House Ways and Means Subcommittee on Health for 
convening today's hearing on ``Strategies to Increase Research and 
Information on Comparative Clinical Effectiveness.'' The College 
strongly supports Congressional efforts to provide Medicare and all 
stakeholders within the healthcare community with improved access to 
information about the relative strengths and weaknesses of various 
clinical products, procedures and services based on the best available 
evidence of clinical effectiveness.
    The Members of this Subcommittee are well aware of the significant 
problems that characterize our current healthcare system:

          the unsustainable growth in healthcare costs that 
        affect both payers and beneficiaries; \1\
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    \1\ Kaiser Family Foundation. Trends and indicators in the changing 
healthcare market place. 2006. Accessed at http://www.kff.org/
insurance/7031/index.cfm on May 9, 2007.
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          the presence of significant quality gaps particularly 
        when compared to other industrialized nations that spend much 
        less on healthcare; \2\
---------------------------------------------------------------------------
    \2\ Anderson G, Hussey PS. Comparing Health System Performance in 
OECD Countries: Cross-National Comparisons Can Determine Whether 
Additional Health Care Spending Results in Better Outcomes. Health 
Affairs. May/June 2001;20(3):219-32.
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          the presence of significant variation in healthcare 
        costs throughout this country without any evidence that 
        increased costs result in improved care.\3\
---------------------------------------------------------------------------
    \3\ Fisher, E., Wennberg, D., et al., The Implications of Regional 
Variations in Medicare Spending: Part 2, Health Outcomes and 
Satisfaction with Care, Annals of Internal Medicine 2003; 138:288-98.

    As stewards of the Medicare Trust Fund and the largest payer of 
healthcare services in the country, it is Congress' responsibility to 
address these problems and help ensure that our taxpayer funds are 
being used effectively to provide high quality care and achieve the 
best possible patient outcomes. The increased production and 
availability to payers, providers and beneficiaries of methodologically 
sound information from a trusted source on the effectiveness of 
alternative treatments would be a good step towards improving the value 
obtained from healthcare dollars spent.
The Public Need for Comparative Clinical Effectiveness Research

    From the perspective of the practicing physician, the increased 
availability of sound comparative effectiveness data has direct 
clinical usefulness. Each day in the privacy of the examination room, 
patients are treated for conditions that have multiple treatment 
options. Here we are talking about treating a common condition like 
intermittent heartburn, to the more serious chronic conditions of high 
blood pressure or diabetes, to the more immediate life and death issues 
of to having to choose the best approach to treat diagnosed breast or 
prostate cancer. The availability of valid, comparative effectiveness 
data supplemented by the physician's clinical experience and 
professional knowledge, helps ensure that an effective treatment choice 
is made--one that meets the unique needs and preferences of the 
patient.
    The College has a long history of supporting evidenced based 
practice, and since 1981 has been developing evidenced-based clinical 
treatment guidelines through its Clinical Efficacy Assessment Program. 
In fact, I was part of the original panel of experts of this program 
and am currently Editor-in-Chief of ``ACP Medicine,'' a continually 
updated, evidence-based reference of internal medicine published by the 
College. My own patient care experiences, as well as the College's 
experience in producing evidence-based analyses, supports the need for 
an objective, evidence-based and refereed source of information from a 
``trusted entity'' to compare the effectiveness of alternative 
healthcare services.
    The United States currently does not have a systemic means of 
producing comparative information on the relative effectiveness of 
drugs, durable equipment, therapies and procedures. The limited amount 
of comparative effectiveness data that is produced is done piece-meal, 
with little or no prioritization relative to the benefits it would 
provide to individual patients and the general population, little 
coordination or harmonization of clinical efficacy efforts, and uneven 
methodological standards for evaluating clinical efficacy and reporting 
the results to clinicians and patients. Often, evaluations are made on 
a ``single therapy'' basis without comparing such therapies to 
alternative treatments. The Federal Drug Administration assesses the 
safety and effectiveness of drugs, and to a less extent medical 
equipment, but the research it considers generally compares performance 
to no treatment (placebo) conditions, rather than to alternative 
products already in the market place. The National Institutes of Health 
(NIH) is this country's largest sponsor of clinical trials that compare 
alternative treatments, but funds for these studies represent only a 
small amount of their budget. The Agency for Healthcare Research and 
Quality (AHRQ) through Section 1031 of the Medicare Modernization Act 
(MMA) was authorized by Congress in 2003 to conduct and support 
research with a focus on outcomes, comparative clinical effectiveness, 
and appropriateness of pharmaceuticals, devices, and health care 
services. I will discuss more about this effort later in my testimony.
    Private sector entities including pharmaceutical companies, 
pharmaceutical benefit managers, health plans and large provider groups 
also produce some comparative effectiveness data, but the details of 
these studies are often not transparent, access to this data is limited 
due to its proprietary nature, and there is evidence questioning the 
objectivity of some of these findings.\4\
---------------------------------------------------------------------------
    \4\ Medical Payment Advisory Committee. Presentation by Nancy Ray 
on Comparative Effectiveness. April 12, 2007 Public Meeting. Access at 
http://www.medpac.gov/public_meetings/transcripts/
0407_allcombined_transcript.pdf on May 9, 2007.
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    This hodge-podge of comparative effectiveness efforts is in marked 
contrast to the activities conducted in a number of other countries, 
including Canada, Great Britain, Germany an Australia. Perhaps most 
recognized of these efforts is the National Institute for Health and 
Clinical Excellence (NICE) program in Great Britain,\5\ which serves as 
a model of a coordinated, prioritized comparative effectiveness program 
designed to promote trust in its finding through transparency in its 
proceedings and strong stakeholder involvement at all levels of the 
process.
---------------------------------------------------------------------------
    \5\ Pearson D, and Rawlins, M. Quality, innovation and value of 
money. JAMA, Nov. 2005;294(20):2618-2622.
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    The College recommends that the Congress take efforts, including 
allocation of secure and sustained funding, to develop or support a 
trust entity that systematically develops evidence on the relative 
effectiveness of various alternative heathcare services.
    While the College currently has no formal position on the structure 
of this entity (i.e. public, private or public-private), it believes 
that this entity should have the following characteristics:

          it should be an unbiased independent entity protected 
        from both governmental and private sector influence to 
        encourage trust in its findings.
          its proceedings should be transparent.
          it should involve stakeholders, including payers, 
        providers and beneficiaries, at all levels of the evidence 
        development process.
          it should have a prioritization process, informed by 
        input from the stakeholder groups, that ensures that the 
        comparative effective evidence developed will have the greatest 
        impact in improving the quality and efficiency of care 
        provided.
          it should support the development of all levels of 
        evidence including formal review and synthesis of evidence 
        already available in the clinical literature and the initiation 
        of new research in priority areas where such evidence does not 
        already exist.
          it should have established processes that ensures 
        that the comparative effectiveness findings developed are 
        accessible in a comprehensive form to all stake holders and 
        reported in a manner that is useful for clinicians and 
        patients.

    The entity that currently best matches this list of characteristics 
is the AHRQ. Through its Effective Health Initiative, this agency has 
established itself as a trusted source of comparative effectiveness 
data. Since its recent implementation, it has produced seven 
comparative effectiveness research reviews, it is in the process of 
developing at least six others and has initiated at least 14 new 
research projects. It has also made a substantial effort to ensure that 
their findings are accessible to consumers, providers and policy makers 
in a meaningful form. The College commends the efforts of the AHRQ and 
has recently urged Congress to increase its level of funding in a joint 
letter signed by the American Medical Association and over 80 other 
medical organizations.\6\
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    \6\ Joint letter on SGR legislative options sent to key 
Congressional Committee staff delivered on May 17, 2007.
---------------------------------------------------------------------------
    If AHRQ is to be the ``trusted entity'' to conduct effectiveness 
research, then it needs to be assured of sufficient and sustained 
funding to support its activities and be protected from the normal 
political influences that arise through the annual appropriations 
process. If Congress chooses to create a new entity rather than 
facilitate increased funding of the AHRQ to advance the development of 
cost effectiveness evidence, it should use lessons learned from AHRQ in 
developing this new entity and assure that the new entity is funded in 
a way that will protect it from political influences that may arise 
through appropriations.

Use of Comparative Effectiveness in Benefit Design Decisions

    The College is also aware of suggestions concerning the potential 
use of this data by Medicare \7\ (and other payers) to redesign their 
healthcare benefits by basing reimbursement and/or patient cost-sharing 
on the comparative evidence developed by the proposed entity. For 
example, those procedures that prove generally more effective could 
receive higher reimbursement and/or require a lower beneficiary co-
payment. The College, although recognizing potential savings obtainable 
through this approach, recommends that Congress walk down the path of 
using comparative effectiveness data in the Medicare benefit design 
slowly and cautiously. It will take time for clinicians and patients to 
develop trust and have confidence in the evidenced produced from any 
new comparative effectiveness evidence producing entity. In addition, 
procedures will need to be developed to ensure that the unique needs of 
each patient can be recognized, and that clinical decisions are based 
upon what is best for this patient, rather than the economic incentives 
promoted by the benefit design.
---------------------------------------------------------------------------
    \7\ Medical Payment Advisory Committee. Presentation by Gail 
Wilensky and Marilyn Moon on Comparative Effectiveness. April 12, 2007 
Public Meeting. Access at http://www.medpac.gov/public_meetings/
transcripts/0407_allcombined_transcript.pdf on May 9, 2007.
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    The appropriateness of including ``cost effectiveness'' as an 
explicit element in comparative effectiveness research is complex and 
controversial. Cost means different things to different people: 
aggregate costs to a payers of services (Medicare), the economy 
(societal costs), the individual (in the form of out of pocket 
expenses, health care premiums, or individual tax payments to support 
public programs), or clinicians (whose professional value system often 
puts primacy of the individual patient's needs and preferences over 
societal costs) are very different from each other and will result in 
different value judgments. How the relative costs of a treatment and 
procedure should be weighted against the evidence of clinical 
effectiveness will involve value judgments that need to be made in an 
open, transparent, and methodologically sound basis that takes into 
account the different values that each stakeholder brings to the table. 
For these reasons, the College suggests that federally-funded 
comparative effectiveness research should, at least in its early 
stages, focus on relative clinical efficacy rather than cost-
effectiveness. At the same time, however, we support further discussion 
of how cost-effectiveness comparisons might be introduced into the 
evaluation process at a later stage and used, at least in part, to 
influence benefit design by Medicare and other programs.
Comparative Clinical Effectiveness Research and Shared Decision-Making

    The greatest initial value of developed comparative effectiveness 
data at this time is to help answer the question of what works best for 
whom and the use of this information in providing effective patient-
centered treatment. Comparative effectiveness research from a trusted 
entity will enable physicians and patients to engage in informed and 
shared decision-making on the most desired and effective treatment 
alternatives for that individual patient. Such shared decision-making 
is a key element of the Patient-Centered Medical Home (PCMH). This care 
model--supported by the 330,000 primary care physicians represented by 
the American Academy of Family Physicians, the American Academy of 
Pediatrics, the American Osteopathic Association and the American 
College of Physicians and a coalition of large employers and consumer 
organizations--would ensure that treatment decisions informed by 
comparative effective evidence will be delivered in a coordinated, 
integrated manner. The model also emphasizes the importance of actively 
making treatment decisions a shared process between the patient and 
their personal physician. Research using an active shared decision 
making process, using available comparative effectiveness evidence, 
indicates it has the potential to reduce unwarranted variations in 
treatment among providers, increase patient accuracy in expected 
treatment outcomes, and provide patients with greater comfort in the 
treatment choice made.\8\
---------------------------------------------------------------------------
    \8\ O'Connor, A. et al. Modifying unwarranted variations in health 
care: Shared dicision making using patient decision aids. Health 
Affairs Web Exclusive, October 7, 2004. Accessed at 
http://content.healthaffairs.org/cgi/reprint/
hlthaff.var.63v1?maxtoshow=&HITS=10&hits=10&RE
SULTFORMAT=&author1=%27Connor&andorexactfulltext=and&searchid=1&FIRSTIND
EX=0&
resourcetype=HWCIT on May 7, 2007.
---------------------------------------------------------------------------
    Finally, the College urges the Subcommittee to report legislation 
to create Medicare payment incentives for physicians to acquire and use 
health information technology (HIT) in their practices as a means of 
facilitating the collection and reporting of clinical data on 
effectiveness and facilitating evidence-based clinical decision support 
and shared decision-making at the point of care.  The availability of 
clinical decision support technology at the site of care will make 
evidence-based comparative research readily available to physicians and 
their patients to support shared clinical decision-making between the 
physician and the patient. The College specifically supports H.R. 1952, 
the National Health Information Incentives Act of 2007, introduced by 
Representatives Charles Gonzalez (D-TX) and Phil Gingrey, MD (R-GA) to 
provide financial incentives to physicians through Medicare to adopt 
and purchase HIT.
Summary and Conclusion

    In summary, the College strongly supports Congressional efforts to 
provide Medicare and all stakeholders within the healthcare community 
with improved access to information about the relative strengths and 
weaknesses of various clinical products, procedures and services. 
Towards this goal, the College recommends that the Congress take 
efforts, including the allocation of secure and sustained funding, to 
create or support a trusted entity that systematically develops 
evidence on the relative effectiveness of various alternative 
healthcare services. That entity should have the following 
characteristics:

          it should be an unbiased independent entity protected 
        from both governmental and private sector influence to 
        encourage trust in its findings.
          its proceedings should be transparent.
          it should involve stakeholders, including payers, 
        providers and beneficiaries, at all levels of the evidence 
        development process.
          it should have a prioritization process, informed by 
        input from the stakeholder groups, that ensures that the 
        comparative effective evidence developed will have the greatest 
        impact in improving the quality and efficiency of care 
        provided.
          it should support the development of all levels of 
        evidence including formal review and synthesis of evidence 
        already available in the clinical literature and the initiation 
        of new research in priority areas where such evidence does not 
        already exist.
          it should have established processes that ensures 
        that the comparative effectiveness findings developed are 
        accessible in a comprehensive form to all stake holders.

      The Congress should give consideration to continuing to 
support the work of the Agency for HealthCare Research and Quality as 
the ``trusted entity'' for comparative effectiveness research, with 
secure and sustained funding that is not subject to the political 
pressures often associated with the annual appropriations process.
      The College believes that the greatest value of developed 
comparative effectiveness data at this time is to help clinicians and 
patients answer the question of what works best for each patient and 
for clinicians to partner with patients in an informed and shared 
decision-making process when considering alternative treatment options, 
a key element of the Patient-Centered Medical Home.
      The College recognizes the potential savings obtainable 
through comparative effectiveness research, but recommends that 
Congress walk down the path of using comparative effectiveness data in 
the Medicare benefit design deliberatively so that more experience is 
gained first in the impact of such research and its credibility with 
clinicians and patients. As confidence and trust in the process 
increases, steps could then be taken by Congress to create a method for 
incorporating such comparative effectiveness research into benefit 
design issues.
      Congress should recognize that inclusion of ``cost 
effectiveness'' as an element of the comparative evaluation process 
will introduce complex and controversial issues of how individual 
patients, purchasers, clinicians, and society assign a relative value 
to clinical effectiveness and cost. Such value judgments need to be 
made in an open, transparent, and methodologically sound basis that 
takes into account the different value systems that each stakeholder 
brings to the table. For these reasons, the College suggests that 
federally-funded comparative effectiveness research should, at least in 
its early stages, focus on relative clinical efficacy rather than cost-
effectiveness. At the same time, however, we support further discussion 
of how cost-effectiveness comparisons might be introduced into the 
evaluation process at a later stage and used, at least in part, to 
influence benefit design by Medicare and other programs.

      The College asks Congress to recognize the value that a 
more systemized approach to developing comparative effectiveness 
evidence can be leveraged through:

          The establishment of mechanisms to facilitate the 
        implementation of health information technology (HIT) 
        throughout the system
          The implementation of the Patient-Centered Medical Home 
        (PCMH) care model.

                                 

    Chairman STARK. Thank you.
    Ms. Shearer?

             STATEMENT OF GAIL SHEARER, DIRECTOR, 
            HEALTH POLICY ANALYSIS, CONSUMERS UNION

    Ms. SHEARER. Mr. Chairman, Members of the Subcommittee, 
thank you very much for the invitation to testify today on 
strategies to increase research on the comparative clinical 
effectiveness of medical treatments. We believe that 
legislation on this issue is the single most important 
investment you can make to moderate runaway health care costs 
and pave the way for a health care system that better meets the 
needs of all Americans.
    Getting better value for our health care dollars is an 
essential building block for health reform, regardless of 
stripe of reform. In so-called consumer-centric models that 
embrace health savings accounts, consumers need to know where 
their dollars are most effective.
    In a system of predominately employer-based health 
coverage, employers have a strong financial incentive to learn 
how to achieve the best health outcomes at the lowest cost. In 
a universal health care system, whether through an individual 
mandate, public/private expansions of coverage, or even a 
Medicare-for-all type of model, the key to success will be 
getting the maximum value from each premium or tax dollar 
spent.
    This is why we believe so strongly in the need for a 
Marshall Plan-like commitment, to transform our knowledge base 
about the comparative effectiveness of medical treatments to 
fill the gaps in clinical research. Armed with this knowledge, 
providers and consumers could identify and choose the best 
treatment options, and payors could fine-tune benefit packages 
and modify cost-sharing amounts to encourage the most cost-
effective care.
    Today I want to concentrate on one public education program 
that we have developed at Consumers Union that uses the best 
available scientific evidence to help consumers, with their 
health care professionals, choose the most effective, safest, 
and affordable drugs. I highlight this work because it provides 
a tangible example of the potential that expanded government-
funded comparative effectiveness research holds for improving 
health care quality and lowering health care costs.
    Consumer Reports' best buy drugs is based on systematic 
reviews, unbiased medical reviews of the clinical research on 
drug comparative effectiveness, safety, and side effects 
conducted by the Drug Effectiveness Review Project. DERP is a 
preeminent example of the pioneering lead that the States have 
taken with financial support from AHRQ's funding of evidence-
based practice centers in the world of evidence-based medicine, 
specifically, the research that is necessary to enable states 
and other health care payors to shape benefit policy based on 
unbiased scientific evidence.
    Our best buy drugs program translates DERP's complex 
medical reports into consumer-friendly reports that provide 
information the public needs to understand the comparative 
effectiveness, safety, side effects, and costs of drug options.
    One of the reports is attached to my testimony today. It is 
on proton pump inhibitors, which are anti-heartburn medicines. 
We found that there is not a large difference between the 
effectiveness of many drugs in this category. The big story, 
though, is that there is a tenfold difference between the 
monthly price of a heavily advertised purple pill, Nexium, and 
the over-the-counter alternative, Prilosec OTC, that the best 
science shows it is equally effective and safe for almost all 
of us.
    A month's supply of Nexium costs about $193, which a 
month's supply of Prilosec OTC costs about $19 to $26. Having 
said this, I want to stress that we always urge consumers to 
consult with their doctors, and we urge all health plans to 
have effective and easy-to-use exceptions policies for the 
small amount of people who may not respond as well to one of 
the best buy drugs.
    In most categories that we have studied, and we have 
studied 17 now, we have found that by switching from a high-
priced, typically highly advertised brand drug to a best buy 
drug alternative, consumers can typically save between $1,000 
and $2,000 a year. Helping consumers and health plans 
substitute effective, safe, lower-cost medicines for the newest 
heavily advertised alternative can save the nation billions of 
dollars without sacrificing quality.
    In fact, better information about comparative effectiveness 
can help us as a nation improve health care quality by 
educating consumers, physicians, pharmacists, and policy-makers 
about the comparative effectiveness of alternative treatments.
    Educating the public about low-cost, effective alternatives 
can help make health care treatments and prescription drugs 
more affordable. This in turn will increase the number of 
patients who can get the treatment or drug that they need, and 
ultimately improve health outcomes.
    Consumers Union believes that it is appropriate for the 
government to fully fund and sponsor this important research, 
which should be available to all and constitutes the epitome of 
a public good. The benefits will be shared by every one of us 
who uses health care in this country.
    Mr. Chairman, Members of the Subcommittee, the rapidly 
rising cost of health care threatens the budgets of Federal and 
state governments, and ultimately of health care consumers. We 
believe that establishing a new program with sufficient 
reliable funding to assess the comparative effectiveness of 
alternative treatments is a necessary part of the solution to 
this growing problem.
    Enacting this legislation is probably the most important 
thing that you can do in this Congress to save lives and money, 
and to build a foundation for further reforms of our health 
care system. Thank you.
    [The prepared statement of Ms. Shearer follows:]

             Prepared Statement of Gail Shearer, Director, 
                Health Policy Analysis, Consumers Union

Mr. Chairman, Members of the Committee:

    Thank you for the invitation to testify on strategies to increase 
information on comparative clinical effectiveness and H.R. 2184, The 
Enhanced Health Care Value for All Act. We believe that this 
legislation is the single most important investment you can make to 
moderate run-away health care costs and pave the way for a health care 
system that better meets the needs of all Americans.
    Consumers Union \1\ is the independent, non-profit publisher of 
Consumer Reports, with circulation of about 7 million (Consumer Reports 
plus ConsumerReports.org subscribers). We regularly poll our readership 
and the public about key consumer issues, and the high cost of health 
care consistently ranks among their top concerns.
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    \1\ Consumers Union is a nonprofit membership organization 
chartered in 1936 under the laws of the state of New York to provide 
consumers with information, education and counsel about goods, 
services, health and personal finance, and to initiate and cooperate 
with individual and group efforts to maintain and enhance the quality 
of life for consumers. Consumers Union's income is solely derived from 
the sale of Consumer Reports, its other publications and from 
noncommercial contributions, grants and fees. In addition to reports on 
Consumers Union's own product testing, Consumer Reports and 
consumerreports.org with more than 7 million paid circulation, 
regularly carries articles on health, product safety, marketplace 
economics and legislative, judicial and regulatory actions which affect 
consumer welfare. Consumers Union's publications carry no advertising 
and receive no commercial support.
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    I would like to commend the Committee for holding this hearing. 
Health care costs currently consume about 16 percent of our gross 
domestic product. This percent is projected to continue to grow at a 
rate substantially higher than general inflation. It is imperative that 
as a nation we learn how to get better value from every health care 
dollar that we spend. We must not continue to pay $5 for a pill when 
there is an equally effective and safe pill that is available for 50 
cents.
    Getting better value for our health care dollars is an essential 
building block for health reform, regardless of the ``stripe'' of 
reform. In so-called ``consumer centric'' models that embrace health 
savings accounts, consumers need to know where there dollars is most 
effective. In a system of predominantly employer-based health coverage, 
employers have a strong financial incentive to learn how to achieve the 
best health outcomes at the lowest cost. In a universal health care 
system (whether through individual mandate, public/private expansions 
of coverage, or even a Medicare-for-all model), the key to success will 
be in getting the maximum value from each premium or tax dollar spent.
    This is why we believe so strongly in the need for a Marshall Plan-
like commitment to transform our knowledge base about the comparative 
effectiveness of medical treatments to fill the gaps in the clinical 
research. Armed with this knowledge, providers and consumers could 
identify and choose the best treatment options, and payers could fine-
tune benefit packages and modify cost-sharing amounts to encourage the 
most cost-effective care. A commitment to funding and increased 
reliance on evidence-based, unbiased clinical research and synthesis of 
existing research should be a leading-edge building block for health 
care reform. What does this mean for coverage? Some possible examples:

          There might be zero co-payments for diabetic care and 
        other medical treatments that are clearly proven and necessary 
        to improve health outcomes. (Some insurers are already 
        experimenting with this approach to provide early care that 
        greatly improves health outcomes.)
          There might be zero co-payments for certain generic 
        drugs, and much steeper co-payments for the equivalent, higher-
        priced brand name drug where appropriate.

    Our health care work on behalf of consumers is varied. Our 
advocates work to improve quality (e.g., our Stop Hospital Infections 
campaign to require public reporting of hospital acquired infection 
rates), to improve safety (e.g., our Prescription for Change campaign 
to reform drug safety laws), and improve affordability (e.g., our work 
since 1936 in support of affordable health care for all). Consumer 
Reports, Consumer Reports on Health, Consumer Reports MedicalGuide.org, 
and consumerreports.org provide comprehensive information about a range 
of health insurance products, health conditions, and treatments. In 
addition, Jim Guest, CU's President and CEO, serves as a member of the 
Institute of Medicine's Roundtable on Evidence-Based Medicine, which 
has been convened to ``transform the way evidence on clinical 
effectiveness is generated and used to improve health and health 
care.'' \2\
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    \2\ Charter and Vision Statement, Institute of Medicine Roundtable 
on Evidence-Based Medicine, http://www.iom.edu/CMS/28312/RT-EBM/
33544.aspx. See also: Institute of Medicine. 2007. Learning What Works 
Best: The Nation's Need for Evidence on Comparative Effectiveness in 
Health Care. http://www.iom.edu/ebm-effectiveness.
---------------------------------------------------------------------------
    But today I want to concentrate on one consumer program that we 
have developed that uses the best available scientific evidence to help 
consumers, with their health-care professional, choose the most 
effective, safest, and affordable drugs. I highlight this work, because 
it provides a tangible example of the potential that expanded 
government-funded comparative effectiveness research holds for both 
improving health care quality and lowering health care costs. Consumer 
Reports Best Buy Drugs \3\ is based on systematic reviews--unbiased 
medical reviews of the clinical research on drug comparative 
effectiveness, safety, and side effects--conducted by the Drug 
Effectiveness Review Project (DERP). DERP, based at the Center for 
Evidence Based Policy at Oregon Health and Science University, 
coordinates the preparation of the careful (and heavily peer-reviewed) 
reports that are written by various Evidence-based Practice Centers 
which receive support from the federal Agency for Healthcare Research 
and Quality (AHRQ). DERP is a preeminent example of the pioneering lead 
that the states have taken--with financial support through AHRQ's 
funding of Evidence-based Practice Centers--in the world of evidence-
based medicine, specifically the research that is necessary to enable 
states and other health care payers to shape benefit policy based on 
unbiased scientific evidence.
---------------------------------------------------------------------------
    \3\ Reports can be downloaded for free at www.CRBestBuyDrugs.org.
---------------------------------------------------------------------------
    Our Best Buy Drugs program translates DERP's complex medical 
reports into consumer-friendly reports that provide information the 
public needs to understand the comparative effectiveness, safety, side 
effects, and cost of drug options.\4\ Thanks to grants from a private 
philanthropy, The Engelberg Foundation, and the National Library of 
Medicine, Consumers Union is able to provide this information free-of-
charge to the public. This is important, since one of our key target 
audiences is low-income consumers who use multiple drugs--the very 
people who are most in need of unbiased, accurate information.
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    \4\ For a more detailed description, see Steven D. Findlay, 
``Bringing The DERP to Consumers: `Consumer Reports Best Buy Drugs','' 
Health Affairs--Web Exclusive, June 6, 2006.
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    Attached to my testimony is a description of Consumer Reports Best 
Buy Drugs and a sample of a 2-page summary for one class of drugs, 
proton pump inhibitors (anti-heartburn medicines). As you can see from 
the table, there is not a large difference between the effectiveness of 
the drugs in this category. The big story, though, is that there is a 
ten-fold difference between the monthly price of the heavily advertised 
``purple pill'' Nexium and an over-the-counter alternative (Prilosec 
OTC) that the best science shows is equally effective and safe for 
almost all of us. A month's supply of Nexium costs about $193, while a 
month's supply of Prilosec OTC costs $19 to $26. Having said this, I 
want to stress that we always urge consumers to consult with their 
doctors, and we urge all health plans to have effective and easy-to-use 
exceptions policies for the small amount of people who may not respond 
as well to one of the Best Buy Drugs.
    We have completed reports for 17 classes of drugs that millions of 
consumers need today, including: statins to lower cholesterol, the 
high-blood pressure and heart disease medicines (ACE inhibitors, 
calcium channel blockers, beta blockers), anti-depressants, 
antihistamines, menopause drugs, attention deficit and hyperactivity 
disorder (ADHD), insomnia, and many more. We are working in six states 
(Arizona, California, Georgia, Maryland, Minnesota, and Pennsylvania) 
on pilot outreach projects to bring this information to as many diverse 
populations as we can. We are working with doctors, pharmacists, senior 
networks, libraries, state officials, health insurance companies, 
PBMs--basically any entity that shares the goal of improving health 
care quality while lowering health care costs. Under our free, 
information-sharing agreement with Medco Health Solutions, for example, 
we are exposing millions of consumers to Consumer Reports Best Buy 
Drugs information when they click through to our drug reports via 
Medco's Internet tool, My Rx Choices, which helps members identify 
effective, lower-cost drug options. We are working with Tarascon, a PDA 
software provider, to provide summaries of our reports on physicians' 
PDAs to help them at the point of prescribing.
    Helping consumers--and health plans--substitute effective, safe, 
lower-cost medicines for the newest, heavily-advertised alternative can 
save the nation billions of dollars without sacrificing quality. In 
fact, better information about comparative effectiveness can help us as 
a nation improve health care quality by educating consumers, 
physicians, pharmacists, and policy makers about the comparative 
effectiveness of alternative treatments. Educating the public about 
low-cost, effective alternatives can help make health care treatments 
and prescription drugs more affordable, and this in turn will increase 
the number of patients who can get the treatment or drug that they need 
and ultimately improve health outcomes. The stakes are huge. The table 
below shows estimates of annual savings for select drug categories for 
consumers switching from a high priced brand to a Best Buy Drug:

------------------------------------------------------------------------
                                                               Potential
                                                              Individual
                      Category of Drug                          Annual
                                                                Savings
------------------------------------------------------------------------
Statins (to lower cholesterol)                                  $1,300
------------------------------------------------------------------------
Proton Pump Inhibitor (for acid reflux, ulcers, heartburn)      $1,740
------------------------------------------------------------------------
NSAIDs (arthritis and pain)                                     $2,200
------------------------------------------------------------------------
Anti-depressants                                                $1,200
------------------------------------------------------------------------
Beta Blockers (high blood pressure)                             $1,900
------------------------------------------------------------------------

    We have estimated that Medicare beneficiaries who select Best Buy 
Drugs in five leading drug categories, when selecting their Medicare 
Part D plan, can save up to $5,000 a year.\5\ Those switching in just 
one drug category can typically save more than enough to cover the cost 
of their Part D premium. Needless to say, on an aggregate level, the 
potential savings to the nation's health care payers (both taxpayers 
and private payers) can be counted in the billions of dollars. And the 
key to realizing these savings is the basic scientific research, the 
clinical studies that compare drugs' effectiveness, and the systematic 
reviews that allow for an unbiased assessment of all clinical research 
that has been done.
---------------------------------------------------------------------------
    \5\ ``Medicare Prescription Drug Benefit: Beneficiaries Can Lower 
Out-of-Pocket Costs While Getting Safe and Effective Drugs,'' Consumers 
Union, March 2, 2006.
---------------------------------------------------------------------------
    The inclusion of Section 1013 in the Medicare Modernization Act 
represented a turning point in health care in the United States, and we 
thank you for that section. By way of background, it is important to 
keep in mind the short history of the highly successful comparative 
effectiveness program. Congressman Allen, Congresswoman Emerson and 
this Committee were instrumental in getting this non-controversial but 
pioneering provision into the Medicare Modernization Act.
    We are very pleased with the work done to date to implement Section 
1013. AHRQ has already released to the public reports \6\ that provide 
consumer-friendly, unbiased reports about the comparative effectiveness 
of various options for a number of conditions. However, this work has 
been funded at a low level ($15 million/year), far less than even the 
level of funding authorized by the legislation. The expectation to date 
has been that Section 1013 as implemented by AHRQ would fund systematic 
reviews rather than actual new clinical trials that assess the 
comparative effectiveness of treatment options. In order to fund new 
comparative clinical trials, a significant commitment of resources and 
leadership will be needed in order to carry out research that will fill 
the gaps in our knowledge about comparative effectiveness of existing 
and future medical treatments. It is important to keep in mind that 
comparative clinical trials are expensive, and can cost between $40 
million and $150 million.\7\
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    \6\ They have produced consumer guides on pain for osteoarthritis, 
and a report on gastroesophageal reflux disease (GERD). Other reports 
(mostly for medical professions) are on cancer, diabetes, the digestive 
system, heart and blood vessels, brain and nerve conditions, and mental 
health. The reports are available to the public at http://
effectivehealthcare.ahrq.gov.
    \7\ ``The Clinical Antipsychotic Trials of Intervention 
Effectiveness (CATIE) cost $42.6 million; the Antihypertensive and 
Lipid-lowering Treatment to Prevent Heart Attacks trial (ALLHAT) cost 
$125 million; the Study of Tamoxifen and Raloxifene trial (STAR) cost 
$118 million.'' Footnote 14, page 7-6, The Future of Drug Safety, 
Institute of Medicine of the National Academies, September 22, 2006.
---------------------------------------------------------------------------
    Consumers Union has endorsed legislation by Representatives Allen 
and Emerson to create a $3 billion comparative effectiveness trust 
fund, by diverting a fraction of each health penny into the fund.\8\ 
The fund would be used by AHRQ, with the advice of a new advisory 
panel, to fund the needed research. The bill insures the principles 
that any research must be independent, scientifically based, 
transparent and public, and include input from all stakeholders, and 
cover the full spectrum of health care treatments.
---------------------------------------------------------------------------
    \8\ The amount proposed, $3 billion over five years, represents 
about.24 percent of projected funding over five years of about $12.3 
trillion.
---------------------------------------------------------------------------
    Consumers Union believes that it is appropriate for the government 
to fully fund and sponsor this important research, which should be 
available to all and constitutes the epitome of a public good. The 
benefits will be shared by every one of us who use health care in this 
country.
    With regard to governance of any new comparative effectiveness 
research effort, we urge you to make sure that the research is 
conducted independent of all the groups whose products and procedures 
it compares. Far too many clinical trials and research papers funded by 
product sponsors have been found to be distorted and biased. Even the 
nation's finest medical journals have found themselves duped by bad 
data and distorted results.\9\ We agree with the principles that have 
been developed by the Alliance for Better Health Care, a broad 
coalition of consumer, labor, health plans, research organizations and 
employers, that works in support of research on comparative clinical 
effectiveness and dissemination of the research.\10\ We commend AHRQ 
for the superb job it has done to date implementing Section 1013, and 
we would urge you to build on the work AHRQ has done by expanding the 
model of systematic reviews it has tremendous success carrying out. We 
urge you to give careful thought, and draw on the advice of experts in 
organizational structures, to assure that the structure to successfully 
implement this large responsibility is solid and assures high quality, 
transparent, independent research and analysis.
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    \9\ PLoS Medicine, May 2005, Vol. 2, Issue 5 e138, ``Medical 
Journals are an Extension of the Marketing Arm of Pharmaceutical 
Companies,'' by Richard Smith.
    \10\ Key principles include the need for a significant and stable 
investment, consideration of the full spectrum of health care 
treatments, scientific integrity and independence, transparency in all 
processes, stakeholder involvement, and accountability of all conduct. 
See Letter from Alliance for Better Health Care to Congressman Allen 
and Congresswoman Emerson, May 14, 2007. *** TO PREVENT BAD 
BREAK AT BODONI DASH *** deg.
---------------------------------------------------------------------------
    Mr. Chairman, Members of the Committee, the rapidly rising cost of 
health care threatens the budgets of federal and state governments, and 
ultimately, the health of consumers. We believe that establishing a new 
program--with sufficient, reliable funding--to assess the comparative 
effectiveness of alternative treatments is a necessary part of the 
solution to this growing problem. A fully funded, thorough comparative-
effectiveness effort would be a wise and cost-effective investment. We 
commend you for giving this legislation serious attention. Enacting 
this legislation is probably the most important thing that you can do 
in this Congress to save lives and money, and to build a foundation for 
further reforms of our health care system.

                                 

    Chairman STARK. Thank you.
    Dr. Hearn?

  STATEMENT OF SUSAN HEARN, Ph.D., SENIOR PROJECT MANAGER IN 
ENVIRONMENTAL HEALTH AND SAFETY, DOW CHEMICAL COMPANY, MIDLAND, 
                            MICHIGAN

    Ms. HEARN. Mr. Chairman, Ranking Member Camp, and Members 
of the Subcommittee, Dow thanks the Subcommittee for holding 
this hearing to examine the benefits of expanding the 
availability of comparative effectiveness research. We, along 
with members of the broader business community, believe that 
improvements in quality and effectiveness of health care are 
absolutely essential in addressing the many challenges facing 
health care.
    Comprehensive, timely generation, and effective 
dissemination of comparative effectiveness research is 
paramount in making progress. Most unfortunately, this is one 
of the most significant voids in information we face today.
    Dow provides comprehensive health care benefits to over 
110,000 employees, retirees, and their dependents in the United 
States. In total, we spent over $300 million on health benefits 
in the U.S. last year, which is equivalent to about 31 cents a 
share or 25 percent of what we spend on research and 
development.
    When you factor in indirect hidden costs to productivity 
from chronic diseases like obesity, the economic impact 
multiplies by a factor of 2 or 3. Absenteeism and presenteeism 
play a big role in pushing our costs up to $700 million a year, 
or about 70 percent of our R&D budget.
    For the money we spend and for the peace of mind of our 
employees and their families, we want to ensure that we are 
getting the best value in health care available. Today, that is 
not the case.
    Medical errors are the eighth leading cause of death in the 
United States, costing billions of dollars a year, and 
inappropriate care represents up to 30 percent of medical 
expenses. Comparative effectiveness research may greatly 
improve health care quality and patient outcomes, ensuring that 
consumers receive the best care at the best value.
    It is extremely important that patients and payors are 
assured the delivery of quality evidence-based health care. 
With adequate funding, comparative effectiveness research can 
provide information to enable physicians to make better 
decisions based on the scientific information elicited in 
evaluating various treatment options.
    Consumers too need comparative information to make better 
informed choices about their health care. As consumers are 
encouraged to get more involved in management of their health 
care, and as consumer-driven health plans become more 
prevalent, consumers will need to know which treatments are 
more effective in treating their particular condition.
    Currently there are relatively few clinical effectiveness 
research studies conducted each year. An increase in funding 
this research could pay off substantially by reducing 
ineffective treatments, thus improving the quality of care, 
improving health outcomes, and saving significant health care 
dollars.
    The Agency for Healthcare Research and Quality conducts 
such research through their Effective Health Care program to 
examine the effectiveness of alternative treatments, and this 
research is producing good results and valuable information to 
help improve outcomes. At the current funding levels, this 
research, however, is just scratching the surface. We encourage 
Congress to significantly increase the funding for comparative 
effectiveness research.
    This research has the potential to improve health care 
delivery and ultimately benefit the health of all Americans by 
reducing inappropriate and ineffective care. Employers like Dow 
will ultimately benefit from the availability of high-quality 
effective treatment and the potential cost savings that are 
expected through a significant reduction in wasteful spending 
on less effective, ineffective, or inappropriate care.
    Our employees will benefit through improved health 
outcomes, and the peace of mind knowing that they have good 
information to help make better health care decisions for 
themselves and their families. This will also benefit Dow by 
reducing the stress and anxiety that can often accompany a 
personal or family illness. This indirect contribution to our 
productivity, having our employees at the top of their game 
always, will help us achieve our vision of being the most 
profitable, most respected, and largest chemical company in the 
world.
    At Dow we have a very clear health strategy which 
emphasizes prevention, quality and effectiveness of care, and 
health system management. We are strongly committed and very 
engaged at the local and national levels, working with many 
partners to drive improvements and achieve better health 
outcomes as well as an improved economic picture.
    However, we can only do so much without the critical 
information provided by comparative effectiveness research. We 
urge you to significantly increase funding for comparative 
effectiveness research and continue to support this 
tremendously important program, and expand the good work of the 
Agency for Healthcare Research and Quality. Thank you.
    [The prepared statement of Ms. Hearn follows:]

               Prepared Statement of Susan Hearn, Ph.D., 
        Senior Project Manager in Environment Health and Safety,
                Dow Chemical Company, Midland, Michigan

    Mr. Chairman and Members of the Subcommittee, I am Susan Hearn, 
Dr.P.H., Senior Project Manager in Environment, Health and Safety for 
The Dow Chemical Company. The Dow Chemical Company (Dow) thanks the 
Subcommittee for holding this hearing to examine the benefits of 
expanding the availability of comparative effectiveness research. We, 
along with the broader business community, believe that improvements in 
quality and effectiveness of health care are absolutely essential in 
addressing the many challenges facing health care. Comprehensive, 
timely generation and effective dissemination of Comparative 
Effectiveness Research (CER) is paramount in making progress. Most 
unfortunately, this is one of the most significant voids in information 
we face today. In this light, funding for CER is viewed as a key 
investment in both improving the health of people and reigning in 
future health care costs. As you have heard from so many, we must as a 
nation find solutions to the affordability of health care or we will 
continue to be at risk in the global economy.
    Dow provides comprehensive health care benefits to over 110,000 
employees, retirees and their dependents in the United States. In 
total, we spent over $300 million on health benefits in the U.S. last 
year--which is equal to about 31 cents a share, or 25 percent of what 
we spend on Research and Development.
    When you factor in the indirect, hidden costs to productivity from 
chronic diseases like obesity, the economic impact multiplies by a 
factor of two to three. Absenteeism and presenteeism play a big role in 
pushing our costs up to $700 million per year or about 70 percent of 
our R&D budget. For the money we spend--and for the peace of mind of 
our employees and their families--we want to ensure that we are getting 
the best value in health care available . . . and today, that is not 
the case.
    Medical errors are the eighth leading cause of death in U.S., 
costing billions of dollars each year, and inappropriate care comprises 
up to 30 percent of medical expenses.
    Comparative effectiveness research (CER) may greatly improve health 
care quality and patient outcomes, ensuring that consumers receive the 
best care at the best value. It is extremely important that patients 
and payers are assured the delivery of quality, evidence-based health 
care. With adequate funding, comparative effectiveness research can 
provide information to enable physicians to make better decisions based 
on the scientific information elicited in evaluating various treatment 
options. Consumers, too, need comparative information to make better 
informed choices about their health care. As consumers are encouraged 
to get more involved in management of their health care and as consumer 
driven health plans become more prevalent, consumers will need to know 
which treatments are more effective in treating their particular 
condition.
    Currently, under authority granted by Section 1013 of the Medicare 
Modernization Act (MMA), the Agency for Healthcare Research and Quality 
(AHRQ) conducts research to examine the comparative clinical 
effectiveness and appropriateness of different treatments, and the ways 
that those treatments can be provided in a more effective and efficient 
manner. Since FY2005, AHRQ has received $15 million per year as funding 
for CER. AHRQ has already released final reports on treatment options 
for breast cancer, gastroesophogeal reflux disease (GERD), cancer-
related anemia, low-bone density, depression and other conditions.
    The findings released by AHRQ have just begun to show the value of 
CER for patients, providers, and health care payers. However, there is 
much more that can be done and, under current levels of funding, AHRQ 
is very limited in the types and numbers of studies it can conduct. To 
remedy this, and to ensure this research contributes fully to improving 
care and saving significant federal dollars, we request that Congress 
act to increase its investment substantially.
    As a member of the Alliance for Better Health Care (ABHC), Dow 
supports the principles developed for prioritizing, conducting, 
disseminating, and using CER.

          CER has the potential to benefit the health of all 
        Americans and is a true public good.
          Significant and stable investment is needed in CER--
        in the development of research methods and researchers, the 
        design and conduct of studies, the scientific review of 
        research, and the dissemination and communication of results--
        for it to reach its full potential.
          The scope of CER should address the full spectrum of 
        health care treatments, including pharmaceuticals, devices, 
        medical and surgical procedures, and other interventions.
          Scientific integrity and independence are paramount.
          CER should be based on scientific evidence employing 
        an array of appropriate methods, such as randomized clinical 
        control trials, observational studies, meta-analyses, and 
        systematic technology assessment reviews.
          The processes for identifying research priorities, 
        conducting research, validating the science, and disseminating 
        results should be transparent.
          Any entity that commissions or conducts CER should 
        involve stakeholders in setting research priorities and 
        disseminating research.
          Board governance should assure accountability in the 
        conduct and dissemination of CER.

    Comparative effectiveness research has the potential to improve 
health care delivery and ultimately benefit the health of all Americans 
by reducing inappropriate and ineffective care. Employers like Dow will 
ultimately benefit from the availability of high-quality, effective 
treatment and the potential cost savings that are expected through a 
significant reduction in wasteful spending on less effective, 
ineffective or inappropriate care. Our employees will benefit through 
improved health outcomes and the peace of mind knowing that they have 
good information to help make better health care decisions for 
themselves and their families. This will also benefit Dow by reducing 
the stress and anxiety that can often accompany a personal or family 
illness. This indirect contribution to our productivity--having our 
employees at the top of their game always--will help us achieve our 
vision of being the largest, most profitable, most respected chemical 
company in the world.
    At Dow we have a very clear health strategy which emphasizes 
prevention, quality and effectiveness of care and health system 
management. We are strongly committed and very engaged at the local and 
national levels working with many partners to drive improvements and 
achieve better health outcomes, as well as an improved economic 
picture. However, we can only do so much without the critical 
information provided by comparative and effectiveness research. Our 
senior physician was a member of the Clinical Research Roundtable 
chartered by the National Academies. This group, which concluded its 
work in 2004, made strong calls for expanded effectiveness research and 
clinical effectiveness research.
    We urge you to significantly increase funding for comparative 
effectiveness research and continue to support this tremendously 
important program and expand the good work of AHRQ.
    The research that would be produced by this effort will be 
invaluable to doctors, other health professionals, and patients, as 
they increasingly demand to know the benefits of various treatment 
options for their conditions. It promises to significantly improve 
quality and safety as we learn more about what medical interventions 
work, how well they work, and which ones do not work.
    Thank you for the opportunity to share our views.

                                 

    Chairman STARK. Thank you.
    Dr. Teutsch?

STATEMENT OF STEVEN M. TEUTSCH, M.D., MPH, EXECUTIVE DIRECTOR, 
 OUTCOMES RESEARCH AND MANAGEMENT, OFFICE OF EXTERNAL MEDICAL 
   AND SCIENTIFIC AFFAIRS, MERCK AND CO., INC., WEST POINT, 
                          PENNSYLVANIA

    Dr. TEUTSCH. Good afternoon, Mr. Chairman and Members of 
the Subcommittee. I am Dr. Steven Teutsch, Executive Director 
of the Outcomes Research Group in the Office of External 
Medical and Scientific Affairs at Merck. Thank you for the 
opportunity to discuss issues of comparative effectiveness in 
health care.
    Merck supports a role for comparative effectiveness 
analysis. We understand the needs of payors, providers, and 
patients for better information on what works and for whom, and 
believe that comparative effectiveness is an important 
mechanism for producing that information.
    We are collaborating with America's health insurance plans 
to develop a road map to provide guidance on how comparative 
effectiveness can be incorporated into coverage decisions, and 
have cosponsored a forum last fall with AHIP and Kaiser 
Permanente on the same topic.
    Companies such as Merck have extensive experience in the 
methods for assessing effectiveness as well. There is a lot at 
stake in a greater national effort to conduct systematic 
comparative effectiveness of medical treatments. Consumers and 
patients want continued access to new, possibly life-saving 
medical interventions. Providers want the ability to practice 
the best medicine for their patients and to keep up with the 
latest information. Payors want rapid diffusion of 
scientifically valid information about what works best, for 
whom, and in what circumstances. Innovative suppliers like 
Merck want continued incentives to develop and market those 
treatments.
    Finally, while comparative effectiveness analysis generally 
produced analyses at the group or sub-population level, 
patients and physicians want to find the best treatment for 
each individual. It will be important to bring the individual 
and population sciences and perspectives together to optimize 
patient management.
    The science of comparative effectiveness has come a 
tremendous way in recent years, and there is a consensus about 
many of the methods. There remain a number of legitimate 
concerns about the scope of comparative effectiveness, as well 
as some specific methods and policy considerations. Among those 
are whether economic analyses should be included, and if so, 
from whose perspective.
    What level of scientific rigor is needed for each type of 
decision? How do we assure transparency of the scientific 
process? Which observational methods are sound, replicable, and 
transparent? How best to proceed when the available evidence is 
insufficient?
    Despite the worries and reservations, I think it is fair to 
say that there is an emerging consensus among various system 
stakeholders on the shape and purpose of a larger national 
effort to conduct comparative effectiveness. This emerging 
consensus seems to be shaping up as follows.
    Comparative effectiveness analysis should be guided by 
input from a broad array of public and private stakeholders. It 
should be applied to the full array of health care 
interventions, including diagnostics, procedures, and devices, 
as well as drugs.
    Resources should target research for diseases or conditions 
that impose a high clinical and economic burden on the health 
care system and society, and where the information can lead to 
improvements in health and efficiencies in the health care 
system. The analyses should be scientifically sound, rigorous, 
predictable, replicable, transparent, and fair.
    New stable sources of funding are needed to generate 
evidence, since much of what is needed does not exist. We also 
need to further develop the methods, assure that the results 
can be used by decisionmakers, and develop the human capital 
necessary to perform the work.
    Comparative effectiveness analysis should be conducted by 
an entity independent of payors, including the government 
payors, and industry. The results should inform clinical 
guidelines for use by medical professionals, quality 
improvement, as well as by payors for coverage and 
reimbursement.
    There are other points that Merck would like to emphasize. 
Results should be used equally by payors and others when the 
results are positive and when the results are negative. For 
example, where the outcome of an evaluation is positive, payors 
should commit to reasonable coverage and encourage appropriate 
use.
    As payors use comparative effectiveness analysis to help 
assess the value of an intervention, they should consider the 
short and long-term value to patients. The purpose should not 
be to hinder access to new technologies, but to assure their 
appropriate use. Comparative effectiveness information cannot 
be static. It must remain current with the state or the 
science, and thus there must be timely processes to incorporate 
new evidence.
    Merck supports actions that bring new resources to bear on 
this work in this country. We believe that, properly 
implemented, it has great potential to assure better 
decisionmaking and improved clinical management. The 
pharmaceutical industry has a great deal of experience in this 
area, and we believe that we have a vision of a better future 
based on an expanded role for evidence-based medicine in 
general and comparative effectiveness in particular.
    I thank you for your time, and would be pleased to answer 
any questions.
    [The prepared statement of Dr. Teutsch follows:]

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    Chairman STARK. Well, thank you all. I guess, first of all, 
Dr. Teutsch, you are a member in good standing of PhRMA? You 
haven't been kicked out?
    Dr. TEUTSCH. Yes. The company is definitely a member.
    Chairman STARK. Dr. Hearn, you are a member in good 
standing of the National Association of Manufacturers? You 
haven't been thrown out?
    Ms. HEARN. Right.
    Chairman STARK. You are not going to lose your 501 status, 
I gather. Everyone is in good shape here. The questions, it 
seems to me, are that we should proceed with outcomes research 
or effectiveness research. There is a question of who, where, 
what. Gail gave us four choices in hers. But what entity does 
this?
    The question of who pays for it, and I think that we get 
unanimity that everybody doesin some manner the taxpayers, and 
in some manner stakeholdersmaybe the docs have to kick in 
through the AMA; I don't knowbut that everybody pays some 
portion of the cost of maintaining this, and that the world has 
free accessand I guess I am asking this of any of you; I will 
get aroundto the information. I can think of no reason other 
than to protect some personal identities that this information 
shouldn't be publicly available to researchers or companies or 
consumers or anybody that wants to use it.
    So, I guess the next question is: How do we get started? 
How do I sell my colleagues on both sides of the aisle that we 
should proceed with this?
    Let me start with Gail. You suggested, I think, most 
prominently as a model, if not the place to start, would be 
AHRQ. Is that a fair assessment?
    Ms. WILENSKY. I believe the better strategy is to have what 
is called a federally funded research and development center 
attached to AHRQ. So, it would have the close linkage to AHRQ 
is very important. I would like just a little distance to try 
to make sure the objectivity and credibility is conferred.
    Chairman STARK. I guess I would just ask if there are any 
of the witnesses who would have an objection to at least 
starting down this road. You are familiar, Dr. Teutsch, with 
some of the Federal bureaucracy and the health bureaucracy.
    Dr. TEUTSCH. Yes. I spent 21 years at CDC, and I had the 
pleasure of working closely with AHRQ on a lot of its evidence-
based development projects. They provide an incredible 
leadership.
    We believe that there really should be some public/private 
partnership to make it work. Gail obviously has given us an 
example of what such a model might look like. We believe that 
there needs to be a structure that does that, but that there is 
also a group of stakeholders, as part of the leadership, that 
can guide the process to make sure it meets the needs of the 
users and all those who have important stakes in that 
information.
    Chairman STARK. somebody suggested a Federal Reserve-like 
entity. But I am just thinking, as legislators, for us to 
create a Federal Reserve, the first problem would be finding a 
suitable site on the Mall. We would be competing with every 
former president for memorials there. That may be somewhat more 
ambitious.
    But I am not so sure that a Federal Reserve-like structure 
attached to AHRQ isI guess it is one thing to say, how do we 
start? It would be wasteful, as far as I am concerned, to spend 
two or 3 years getting some kind of a commission to decide 
where are we going to start this entity. My instinct would be 
to say, start it with AHRQ and have some kind of a sunset three 
or four years out to see how they are progressing, and then 
legislators could make a change if it wasn't working.
    Would there be anybody on the panel that would be 
uncomfortable with that sort of a procedure?
    Ms. WILENSKY. The only hesitation and the answer is no. But 
as a temporary measure, if this grows to be the size that I 
think it needs to be, which is a couple billion dollars when we 
are spending $2 trillion on health care, that kind of a size 
would totally overwhelm AHRQ. AHRQ would become the Center for 
Comparative Clinical Effectiveness Analysis.
    AHRQ is the only place where any health services research 
gets done. There are so many other questions that once this is 
started, I think it needs to be in a slightly removed place.
    This is a discussion I have had with Carolyn Clancy on 
several occasions, and my understanding is she is quite 
comfortable with this not quite an AHRQ but directly linked to 
AHRQ because you want to make sure that there as I a close 
working relationship.
    Chairman STARK. But using AHRQ as a model, with some 
additions.
    Ms. WILENSKY. Right.
    Chairman STARK. Dr. Teutsch, you mentioned something about 
the idea, and I am not so sure that we could sell that, as I 
that there be some requirement that where there is a savings, 
either an improvement in health or a cost savings to 
stakeholders, that it be required.
    I am afraid, if that is what I understood your testimony to 
be, that we ought to have a mechanism for saying if something 
appears as Consumers Union might show us, that it saves us, as 
individuals, a lot of money.
    I am not sure we could get much further than that, and I 
would be troubled by saying we would do anything except require 
that the information be put out there, and that the 
stakeholders, whomever they may be, use it as they choose 
without any mandates from us. I don't think politically that 
wouldbut maybe I misunderstood what you were saying.
    Dr. TEUTSCH. Well, we are certainly not talking about 
mandates ensconced in legislation. But this is a partnership 
for which we all have to contribute in order to reach that 
common good of getting appropriate care to patients and getting 
the value for our health care dollar. That is going to require 
a commitment to a common goal on all parts so that we then 
develop the kind of quality improvement and reimbursement all 
parties align to try and deliver that value.
    What we are talking about here is understanding where that 
value will be and providing that information. But we believe 
all stakeholders have to have a common commitment to that 
common goal.
    Chairman STARK. I like the idea of a commitment, like a 
pledge of allegiance. But that is okay. But to memorialize it 
in legislation would trouble me some because as good a job as 
you may do, with something for my kids, if you don't get rid of 
the bubble gum flavor, they ain't ever going to buy a Merck 
product, I can tell you, regardless of what the commission 
would say they should do. So, there are some levels at which 
you may never get the consumers to march in lockstep.
    Well, I guess I would just as soon give Dave Camp a chance 
to try and defeat what seems to be a unanimous recommendation 
here.
    Mr. CAMP. No. I actually liked what I have been hearing.
    Chairman STARK. Good.
    Mr. CAMP. Thank you, Mr. Chairman. I think there is a lot 
of bipartisan support on this entire concept in the way to move 
forward. I think it has been a good hearing. So, thank you for 
having it.
    I notice, Dr. Wilensky, in your testimony you mentioned 
that the political vulnerability of the center is probably the 
most critical issue. Dr. Mark Miller earlier said if it is 
connected to a Federal agency, they won't deliver any bad news, 
this center.
    I notice you have got a model where there is a tie to AHRQ, 
but somewhat independent. How do you think we best avoid this 
problem of the difficult issues? This will be very 
controversial information, I think, at times; obviously, very 
helpful at times as well.
    Ms. WILENSKY. Right. There is no perfect placement. So, I 
want people to understand that. Everything is involving a 
tradeoff between credibility and independence, objectivity.
    The removal of being exactly a part of AHRQ, although the 
legislation could describe how the information is able to be 
released to the publicI mean, that is something legislation 
could do I was more concerned. I have spoken to a number of 
groups, industry but academic health centers or individuals on 
the right and left of the political spectrum. The sense I had 
is having this function directly in government AHRQ, NIH, new 
agency left a lot of people feeling very uncomfortable. It was 
too close to government.
    That was why, to me, having the FFRDC linked to AHRQ was 
appealing because on the other hand, you want to make sure you 
have accountability. I mean, there are a lot of ways to remove 
it from government. You could put it attached to the Institute 
of Medicine, which I think is another option. You could have it 
ms freestanding.
    But if there is going to be a lot of public money here, I 
have heard from Members and congressional staff that there is 
in having make sure that there is a real accountability. That 
is why the notion of having it linked to AHRQ was so appealing 
as the best tradeoff, close but not too close, to government.
    That seemed to strike the bell, so that I have moved 
forward in the last 6 months in my thinking of being more 
specific that I believe that is the best tradeoff. But I would 
certainly not object to other kinds of tradeoffs.
    Mr. CAMP. Yes. Well, it is a good suggestion. You view a 
board similar to a MedPAC board, with a variety----
    Ms. WILENSKY. Absolutely.
    Mr. CAMP [continuing]. Of members that oversee this 
organization?
    Ms. WILENSKY. You need to have all the stakeholders 
governing what goes onindustry, academia, patient advocates. 
The consumers have to be involved. If they are not there, they 
are going to be lobbing grenades from the outside.
    So, the need to be on the governing board as to how 
decisionmakinghow priorities are set; making sure the 
information is fair and credible. Practicing physicians in 
addition to the academic medical Committee have to be 
represented. Everybody is going to be affected by this.
    Mr. CAMP. I appreciate that. I wondered if anyone would 
like to comment. First of all, I want to thank you all for your 
testimony. It is very helpful.
    I notice, Ms. Shearer, this best buy drugs program really 
looks at the presence of a single disease. Many people, 
particularly seniors, have multiple chronic illnesses and take 
multiple prescription drugs. It is really that dynamic that I 
think we have to be concerned about as we move ahead. My 
concern is if you look at the best buy for a particular drug, 
it may not relate with the entire health regimen an individual 
is on. Can you comment on that?
    Ms. SHEARER. Yes. That is a very, very important point. 
That really goes to the heart of why each of our reports says 
that recommends that the patient talk with their doctor. Each 
of the systematic reviews that form the basis of our analyses 
do look at co-morbidities, and we do try to include that 
information. If a person has various conditions, there may be a 
different recommendation.
    So, to the extent possible, we try to address that in our 
reports. But we always say that this is not about consumers 
picking their medicine, but they should talk with their health 
care provider.
    Mr. CAMP. Last, Dr. Wilensky, you are viewing this 
organization has the bulk of its funding from government 
sources, but that there would be a significant private sector 
component to this as well. How do you see that?
    Ms. WILENSKY. There are two ways to do that. The law allows 
for up to 30 percent of the funding to come from the private 
sector. It is frequent that these FFRDCs and there is a good 
description, I think, in MedPAC, and also the Institute of 
Medicine has a very good description of some existing FFRDCs. 
So, you can look at what is out there. How long. How big.
    It could be through voluntary contributions. We have some 
very large foundations that are interested in this type of 
work, the Robert Wood Foundation. But also, several of the 
insurance companies when they have converted to for-profit 
status have set aside. These large foundations, they are all 
expressing an interest.
    So, one possibility is to have that. Another is to have 
just a direct assessment. Then you could decide, does that 
really count for being private? Or if it is a direct 
assessment, is that public? I don't know what the legal ruling 
would be.
    It is the flexibility, and particularly in the startup, but 
even ultimately having some private sector dollars in there to 
make people feel like they are directly a part of the process. 
But of course, you need to make sure there are a lot of rules 
in place so that you can't have that influence what goes on in 
terms of the studies.
    But of course, that happens with FDA all the time. PhRMA 
companies do the trials or fund the trials. They just have to 
be subject to auditable results. They have to follow the rules 
or the results aren't acceptable to the FDA review process. So, 
we think there are some models as to how that part of it could 
work.
    Mr. CAMP. All right. Thank you. Thank you, Mr. Chairman.
    Chairman STARK. Mr. Johnson?
    Mr. JOHNSON. Thank you, Mr. Chairman.
    Dr. TEUTSCH. how do you ensure that comparative 
effectiveness research is not misused in ways to discourage 
medical advances, and how do we make sure that the research 
supports the quest for an implementation of new breakthrough 
therapies?
    Dr. TEUTSCH. That would be a concern, of course, that a 
manufacturer would be likely to have, too. But we believe in 
the medications and the innovation that industry delivers. We 
believe that by developing products that provide real value, 
making sure that value is clearly understood, and then that we 
have the processes to help translate that so that the right 
patients get them at the right time, are all ways to assure 
that that innovation is adequately rewarded.
    So, we actually see this as very much part of the solution 
to stimulate innovation, and even personalized health care, as 
we go forward.
    Mr. JOHNSON. So, the doctor combines it?
    Dr. TEUTSCH. Well, doctors do need that information, and 
Dr. Dale can talk about it. It is very difficult to keep up 
with all the current information that is available out there. 
You heard earlier that there is a wide variation in care. What 
we want is not homogeneity of care. We want to have doctors 
with the right information to deliver the best information to 
patients.
    When we talk about comparative effect issues, it doesn't 
mean one size fits all. It means understanding the tradeoffs 
among these different innovations to where they fit most 
appropriately into care, and how we take advantage of the 
diagnostic products and other kinds of information so doctors 
can make better decisions.
    This feeds into the systems of decision support that will 
allow doctors to have the information that they need so that 
they can have the information that is scientific, but then 
weigh it, along with the uncertainties and the preferences and 
the values that the patients, the communities, and the 
profession holds to make better decisions.
    Mr. JOHNSON. Thank you, sir. Thank you, Mr. Chairman.
    Chairman STARK. Let me try one more, if I can try the 
patience of the panel.
    In trying to legislate, trying to create this $2 billion 
giant whichI mean, I am trying to think of how you ease into 
this and can establish a protocol. For example, Dr. Dale, I 
don't think we could start right away with surgical procedures 
because I think you have got to wait 5 years or so to find out, 
not that you lived through the operation but how is your life 
five years later, to really study the effectiveness.
    That gets me to the point thatand I don't mean to pick, Dr. 
Teutsch, on your industry, but we do have an awful lot of 
information about pharmaceuticals already, starting from the 
genesis at FDA. Zocor is the same Zocor in California as it is 
in Michigan as it is in Maine. So, we are not talking about 
differentthey may use it differently in different parts of the 
country.
    But what if we started with that areaadmittedly, physicians 
would be involved because some physicians would administer the 
pharmaceuticals differentlyand then proceed, maybe take up the 
vices or physician practices, as we get the ability to collect 
the information.
    Would there be any down side in that, just as a way to 
begin? Dr. Teutsch, could Merck live with that?
    Dr. TEUTSCH. I think that that actually creates some 
issues. The reason is, the pharmaceutical side is a but like 
looking under the lamppost because we do have good information.
    In fact, the real paucity of information tends to be on the 
utility of diagnostic devices and procedures. That is where 
some 90 percent of the cost is. So, it is going to be important 
to look at those technologies and help drive the generation of 
that information.
    So, we do need to look broadly, and in fact not look where 
the information is best, but actually try to figure out where 
there is a paucity of information where decisions are sub-
optimal because of the lack thereof.
    Chairman STARK. Dr. Dale?
    Dr. DALE. Well, I will just comment. I think there is room 
for good work in all those areas. For instance, in the follow-
up on surgical patients, having an adequate record system to 
know what the long-term consequences are. For instance, in our 
country now with the rampant use of obesity surgery, what 
happens? For the next patient, how do you describe what is 
likely to happen to that person?
    So, I think there is room in surgery and in devices. But I 
would also say in terms of the long-term use of drugs as well. 
Many side effects are not recognized in the early phase of 
clinical trials when it is clear that there is an effect. But 
the long-term consequences of use need to be better studied.
    Ms. WILENSKY. I think if you want to affect spending, you 
really have to move away from just the drug focus. That is just 
10 cents of the dollar. A study that was recently reported
    Chairman STARK. I didn't imply that we wouldn't do it all. 
I am just saying at some point you have got to start.
    Ms. WILENSKY. But I think if you think about a staggered 
research agenda, where you want to have some early wins because 
you want to make sure to everyone it is clear why this is good 
investment.
    But looking at areas that either high cost or high volume, 
we could look at a couple of the major DRGs as to where are we 
spending our money, where there are significant differences 
about how you could go at delivering the care. There are a lot 
of dollars attached.
    A recent study that was released that looked at the whole 
issue of stenting versus angioplasty versus conservative 
treatment of medicine versus bypass surgery indicated the kinds 
of questions that are still out there. It is only the first 
look at a broad-based set of questions in cardiovascular 
disease.
    But cardiovascular disease, orthopedic surgeryI mean, these 
are areas where there is a lot of money and a lot of 
uncertainty in variation trying to inform who actually gains. 
Because the answer is almost always going to be for some people 
these aggressive interventions are really important.
    The question is, what about the other groups? What can we 
say about how to help them that may result in a lot of reduced 
spending because they don't need such aggressive treatment? It 
is the binary all-or-nothing thinking that tends to get us in 
trouble.
    If it is really important for one small subgroup of the 
population, does that mean it is useful for everybody that 
might have something that looks related? That is the kind of 
work that we have got to get started on or we will never be 
able to get Peter Orszag's money scored.
    Chairman STARK. Is there anyone else who would like to 
comment before you go to lunch?
    Ms. SHEARER. Well, I would just like to make one point. I 
think that Mr. Orszag gave us a very cautious read on potential 
savings. I think it is important for the Committee to keep in 
mind that the drug effectiveness review product is already 
yielding huge savings on behalf of states that use that 
information for their Medicaid programs.
    So, I think that there is tremendous potential. I think 
that it could be realized sooner than he may have thought in 
his cautious analysis.
    Chairman STARK. Well, in the absence of any of the 
witnesses that would like to add any more comment to the 
record, I would ask Mr. Camp if we can keep the record open so 
that Dr. Clancy and others could respond to written questions 
by Members. You may find in the coming days that Members will 
send some of you written requests, which we would hope you 
might be willing to respond to for the record.
    I want to thank you for your patience and your contribution 
to this very much. Thank you very much. The hearing is 
adjourned.
    [Whereupon, at 12:44 p.m., the hearing was adjourned.]

                                 

    [Submissions for the Record Follow:]

          Statement of Advanced Medical Technology Association

    We thank the Committee for holding this important hearing today on 
strategies to increase information on comparative clinical 
effectiveness.
    AdvaMed is the largest medical technology trade association in the 
world. AdvaMed member companies produce the medical devices, diagnostic 
products and health information systems that are transforming health 
care through earlier disease detection, less invasive procedures and 
more effective treatments. Our members produce nearly 90 percent of the 
health care technology purchased annually in the United States and more 
than 50 percent purchased annually around the world. AdvaMed members 
range from the largest to the smallest medical technology innovators 
and companies. The medical technology industry directly employs 
approximately 350,000 workers in the U.S.
The Important Role of Research to Guide Clinical Decision-Making
    AdvaMed is strongly committed to the principles of evidence-based 
medicine and we support comparative effectiveness research as a means 
to improve clinical outcomes and promote access to quality of care. 
Sound comparative effectiveness research can be used to assist patients 
and physicians in medical decision-making by identifying the relative 
advantages and disadvantages of alternative means to prevent, diagnose 
and treat disease.
    For any government-funded comparative effectiveness research 
initiative, we believe that the following principles should be applied 
to ensure that comparative effectiveness research is carried out 
appropriately:

          Patient-centered care and independent professional 
        medical judgment. Comparative effectiveness research should 
        inform medical decisions, not replace medical judgment with 
        national treatment formulas. Its objective should be to provide 
        better evidence for physicians and patients to use in making 
        individual clinical decisions for each patient's. unique 
        condition.

          Protecting patient access. Comparative effectiveness 
        research typically analyzes which medical intervention, on 
        average, is usually more effective across a population. The 
        intervention that is ``generally best,'' however, may not be 
        best for each individual patient. A determination of what may 
        be more effective on average may not account for the age or sex 
        of a patient. It wouldn't consider what is most effective under 
        the presence of comorbidities or special patient care needs. 
        Therefore, the entity should neither make recommendations nor 
        decisions about coverage. In addition, comparative 
        effectiveness research should not be used by Medicare, 
        insurance companies, or other payers to deny coverage. Patients 
        should maintain access to treatment options based on their 
        needs and preferences, including the desire to receive an 
        intervention that may be determined to be on average less 
        effective, but may be less painful or provide for shorter 
        recovery times for the patient.

          Setting priorities. The comparative effectiveness 
        research agenda must be prioritized and designed with pre-
        stated objectives, research questions, and stakeholder input. 
        It should focus resources on areas that have major clinical 
        significance and will have the greatest return on investment. 
        The agenda development process must be open and include 
        practicing physicians, patients, manufacturers, and other 
        stakeholders.

          Robust databases and analysis. It is critical that 
        effectiveness be evaluated over a period of time that is 
        appropriate for the specific intervention being evaluated. 
        Studies should be based on the time period over which all 
        relevant benefits and other factors accrue, not set 
        arbitrarily--at 30 or 60 days, or 1 year. In addition, any 
        database that is used to assess the effectiveness of an 
        intervention must include robust data on that particular 
        intervention.
Using Clinical Information to Improve the Quality of Care and 
        Efficiency of the Health Care System

          AdvaMed strongly supports using clinical information 
        that exists or could be derived from comparative effectiveness 
        research to improve patient care and reduce waste and 
        unnecessary costs in the health care system. Improvements could 
        include:

                  Advances in the quality of care provided, 
                including the appropriate use of preventive, screening 
                and diagnostic services and reduction in medical/
                medication errors;
                  Changes in clinical processes that eliminate 
                practices that are not beneficial, as determined by a 
                consensus of the peer-reviewed literature or by the 
                relevant medical specialty societies; and
                  Improvements in administrative or health care 
                delivery processes, such as through the use of 
                information technology or the reduction of unnecessary 
                emergency room use.

    For example, for more than a decade medical researchers have known 
that people on ventilators should generally have their heads elevated. 
When the patients are lying down, bacteria can easily travel from the 
stomach, up to the mouth and breathing tube, and ultimately into the 
lungs, causing pneumonia. When people are propped up, gravity becomes 
their ally, but hospitals have had a hard time translating this 
scientific knowledge into better medical care. Patients frequently need 
to be put on their backs, to be bathed or to receive treatment, and 
once they are lying down, doctors and nurses, who are busy worrying 
about dozens of other things, don't always remember to move the bed 
back up. The solution is to set up a rule that every patient on a 
ventilator had to be sitting up. Making common-sense practice pattern 
changes such as these to reduce infections in the intensive care unit 
do not involve cutting-edge science, but can make a big difference, 
cutting the incidence of ventilator-associated pneumonia by more than 
40 percent in some hospitals. It can be the difference between life and 
death for some patients.
    We think there are potentially great opportunities for both quality 
improvement and cost savings in these types of health system changes. 
As a result, we believe that a government-funded comparative 
effectiveness research initiative should include this type of research 
involving health system changes that affect the management and delivery 
of health care items, services, and procedures.
Appropriate Uses of Comparative Effectiveness Research
    Comparative effectiveness research should be used to inform medical 
decisions, not replace medical judgment with national treatment 
formulas. We recommend:

          Studying clinical effectiveness only. Patients should 
        have access to the interventions that are best for them. 
        Consequently, comparative effectiveness research should study 
        clinical effectiveness only, with the goal to inform medical 
        decision-making. As a result, quality of care and overall 
        efficiency in the health care system should improve.

          Recognizing the process of medical device innovation. 
        Medical device innovation is evolutionary, and the 
        effectiveness of a particular product is dependent on the 
        training, experience, and skill of health care professionals. 
        Since many devices are a component of a medical procedure, 
        introduction of a new product may require that physicians 
        develop new skills. For example, the introduction of 
        percutaneous transluminal cardiac angioplasty (PTCA) during the 
        1980s offered an alternative to cardiac bypass surgery but 
        physicians needed additional training in order to perform the 
        procedure. The existence of a ``learning curve'' can be an 
        important constraint on the speed of introduction of a new 
        medical procedure.

    As physicians gain experience with the device, they may be better 
able to identify patients who are suitable--or not--for the therapy. 
They learn how to recognize subtle anatomical differences that 
influence how best to perform the procedure. Experience also helps the 
clinician learn to tailor after care for the needs of a particular 
patient. A case in point is bariatric surgery for weight loss. Clinical 
practice guidelines recommend a training program involving at least 10 
open procedures or 25 laparoscopic procedures performed under the 
supervision of a qualified proctor. The development of this training, 
experience and skill can have a major impact on patient outcomes.
    Furthermore, research that is conducted too early may quickly 
become dated, and a snapshot of a particular device at a specific time 
may incorrectly state its relative effectiveness. Accordingly, studies 
on the comparative effectiveness of devices should consider the effect 
of training and experience upon outcomes, should be applicable to the 
current generation of technology, and should only be conducted when the 
technology has an experience base and is widely available and mature. 
Likewise, those using the studies should recognize these challenges and 
limitations.

          Transparency and stakeholder input.  Comparative 
        effectiveness research must be developed and conducted in an 
        open and transparent fashion that incorporates stakeholder 
        input. This must include all aspects of research to enhance the 
        credibility of its conclusions, including the determination of 
        research priorities, the research methodology, and opportunity 
        to comment on the proposed findings through a formal peer 
        review process. Stakeholders should include patients, 
        physicians, hospitals, and experts from the medical device and 
        diagnostics industry. Governance of any public-private entity 
        should include representation of all stakeholders.

          Defining quality and benefit appropriately. 
        Comparative effectiveness research should be both comprehensive 
        and tailored to the specific intervention being evaluated. For 
        example, because diagnostics are used to inform clinical 
        decision-making, such technologies should be evaluated based on 
        their impact on patient care management. Comparative 
        effectiveness research should consider the influence of health-
        related quality of life (including disability reduction, 
        functional status, reduction in pain, and overall patient 
        satisfaction); work loss and productivity loss; patient 
        adherence; patient preferences and lifestyle choices; symptom 
        control; reduction in medical/medication errors and enhancement 
        of patient and healthcare worker safety; and estimated long-
        term outcomes (which may result long after a clinical trial has 
        ended).

          Supporting personalized medicine. For personalized 
        medicine to flourish, comparative effectiveness research 
        findings should be used as a reference, not a mandate, for 
        individual treatment decisions. As scientific advances in 
        technology continue, genomic and proteomic analysis, health 
        information technology, and other innovations in health care 
        have the potential to promote tailored treatment decisions for 
        each individual patient's unique needs, thereby saving patients 
        from unnecessary care and saving the health care system from 
        the expense of trial-and-error approaches to therapy.

          Communication of findings and conclusions. Research 
        findings should be communicated in a fashion that clearly 
        acknowledges any limitations of the research and underlying 
        data. Armed with the knowledge of which conclusions can and 
        cannot be drawn, patients and physicians will be able to use 
        the research findings appropriately for individual diagnosis 
        and treatment situations. Details regarding the assumptions and 
        data sources should also be readily available. At the same 
        time, there should be a system for assuring that health 
        professionals making decisions are aware of the findings of 
        comparative effectiveness studies.

          Congressional oversight. Any government funded 
        comparative effectiveness research initiative, whether 
        conducted through existing agencies or a newly formed 
        organization, should be subject to Congressional and executive 
        branch oversight.
Conclusion
    Thank you again for holding this important hearing. As supporters 
of evidence-based medicine, we look forward to working on this effort 
to deliver the right treatment to the right patient at the right time.
    We believe that comparative effectiveness research is a means to 
improve clinical outcomes and promote access to quality care. It can be 
used to assist patients and physicians in medical decision-making for 
prevention, diagnosis and treatment.
    However, comparative effectiveness research should be used to 
inform medical decisions, not replace medical judgment with national 
treatment formulas. It should enhance, not hinder independent 
professional medical decision-making. Since comparative effectiveness 
research looks at what is best on average for patients, protections 
must be established to ensure patient access to treatments, drugs, and 
devices that meet their individual needs.

                                 

          Statement of Coalition for Health Services Research

    The Coalition for Health Services Research (Coalition) is pleased 
to offer this testimony for the record regarding the promise of 
comparative effectiveness research. The Coalition's mission is to 
support research that leads to accessible, affordable, high-quality 
health care. As the advocacy arm of AcademyHealth, the Coalition 
represents the interests of 3,800 researchers, scientists, and policy 
experts, as well as 135 organizations that produce and use health 
services research.
    Health care in the United States has the potential to improve 
people's health dramatically, but often falls short and costs too much. 
Health services research is used throughout the health care field to 
understand how to better finance the costs of care, measure and improve 
the quality of care, and improve coverage and access to affordable 
services. As an emerging science in the broader field of health 
services research, comparative effective research--where 
pharmaceuticals, medical devices and medical procedures used to treat 
the same conditions are evaluated for their relative safety, 
effectiveness, and cost--has great potential to improve health care 
quality and patient outcomes while ensuring that consumers receive the 
best care at the best value. When optimally funded, comparative 
effectiveness research has the promise to inform health care decisions 
that are:

          Patient-specific, enabling doctors to make 
        individualized treatment decisions according to patient 
        characteristics (sex, age, and race/ethnicity).

          Evidence-based, providing patients and practitioners 
        with the timely, scientific information they need to evaluate 
        which treatment options will help them achieve better outcomes.

          Value-driven, empowering patients to make informed 
        decisions in the face of rising health care costs and myriad 
        treatment options.

    There are increasing examples that demonstrate how comparative 
effectiveness research provides the scientific basis needed to make 
better decisions when it comes to the care we give and receive:

          The Agency for Healthcare Research and Quality (AHRQ) 
        found that episiotomies--a preemptory incision intended to 
        prevent pregnant women from tearing tissue during labor--has no 
        positive benefit, and probably results in more complications 
        and causes more pain than if no incision was made during 
        childbirth.i The report will save millions of women 
        from having to undergo this painful procedure, not to mention 
        the costs saved by eliminating the routine use of this 
        procedure.
---------------------------------------------------------------------------
    \i\ Viswanathan, M., et. al. ``The Use of Episiotomy in Obstetric 
Care: A Systemic Review,'' Agency for Healthcare Research and Quality 
(May 2004). Available on the Web at www.ahrq.gov/downloads/pub/
evidence/pdf/episiotomy/episob.pdf.
---------------------------------------------------------------------------
          Another AHRQ study found that drugs can be as 
        effective as surgery in management of gastroesophageal reflux 
        disease (GERD)--where stomach acid enters the esophagus, 
        causing heartburn and potential esophageal damage.ii 
        GERD is one of the most common health conditions among older 
        Americans and results in $10 billion annually in direct health 
        care costs. Knowing that, for the majority of patients, drugs 
        can be as effective as surgery in relieving the symptoms could 
        result in significant health care savings and improved quality 
        of life.
---------------------------------------------------------------------------
    \ii\ Ip, S., et. al. ``Comparative Effectiveness of Management 
Strategies for Gastroesophageal Reflux Disease,'' Agency for Healthcare 
Research and Quality (Dec. 2005). Available on the Web at 
www.effectivehealthcare.ahrq.gov/reports/final.cfm.
---------------------------------------------------------------------------
          The National Institute of Mental Health (NIMH) found 
        that, within a class of antipsychotic drugs, the older, less 
        expensive drug (Perphenazine) was just as effective and caused 
        no worse side effects than the three newer, more expensive 
        drugs in treating patients with schizophrenia. One of the newer 
        drugs (Zyprexa) was slightly more effective in controlling 
        systems than the other drugs, but at the cost of serious side 
        effects.iii This study enables greater flexibility 
        in care and informs patients and providers about costs and 
        quality of care.
---------------------------------------------------------------------------
    \iii\ Lieberman, J.A., et. al. ``Effectiveness of Antipsychotic 
Drugs in Patients with Chronic Schizophrenia, '' New England Journal of 
Medicine, Vol. 353, No. 12, pp.1209-1223 (Sept. 22, 2005). Available on 
the Web at http://content.nejm.org/cgi.content/abstract/353/12/1209.
---------------------------------------------------------------------------
          In a study of more than 2,200 patients funded mostly 
        by the Veterans' Administration, researchers found that those 
        who underwent non-emergency angioplasty--a procedure where a 
        tiny wire-mesh tube called a stent is placed in an artery to 
        hold it open--were no less likely to suffer a heart attack or 
        die than those who took only aspirin and other medicines to 
        lower blood pressure and cholesterol and prevent clots, along 
        with adopting lifestyle changes.iv The procedure, 
        often performed to relieve chest pain and to reduce the risk of 
        having or dying from a heart attack, costs about $50,000 and 
        has become one of the most common medical procedures in the 
        United States.
---------------------------------------------------------------------------
    \iv\ Boden, W.E., et. al. ``Optimal Medical Therapy with or without 
PCI for Stable Coronary Disease,'' New England Journal of Medicine, 
Vol. 356, No. 15, pp. 1503-1516 (April 12, 2007). Available on the Web 
at http://content.nejm.org/cgi/content/abstract/356/15/1503.

    As these examples suggest, comparative effectiveness research can 
contribute greatly to better health care at lower cost. It is a true 
public good, providing a basis for improvements in our health care 
system that benefit the general public. Americans overwhelmingly agree. 
According to a 2005 Research!America survey, approximately 95 percent 
of Americas agree that it is important to support research that focuses 
on how well the health care system works and how it could work better, 
and that health care services should be based on the best and most 
recent research available.v
---------------------------------------------------------------------------
    \v\ Woolley, M. and S. Propst. ``Public Attitudes and Perceptions 
about Health-Related Research.'' Journal of the American Medical 
Association, Vol. 294, No. 11, p. 1382 (Sept. 21, 2005).
---------------------------------------------------------------------------
    Despite the promise of, and general support for, comparative 
effectiveness research, this type of health services research by 
definition often results in ``winners'' and ``losers,'' making the 
entity that commissions this research vulnerable and susceptible to 
attack. For example, if research based on post-marketing surveillance 
finds that device ``A'' has better outcomes and fewer risks than drug 
``B,'' one would expect the demand for device ``A'' to increase at the 
expense of drug ``B.'' The manufacturer of drug ``B'' might then 
attempt to leverage the political process to discredit the research 
and, as has happened in the past, exert political pressure to 
substantially reduce the funding for, or even abolish the entity 
funding, the research.
    Given the potentially controversial nature of comparativeness 
effectiveness research findings, in September 2005 AcademyHealth issued 
a report that provided guidance on the placement, structure, and 
funding of comparative effectiveness research (see appendix 
A).vi The AcademyHealth report recommended that comparative 
effectiveness research be established either within AHRQ or through the 
creation of a new entity that would, in varying degrees, be linked the 
lead agency for health services research. As part of this 
recommendation, the report identifies four structural options for the 
placement of this critical research function. These options range from 
fully embedding the comparative effectiveness function in an 
established federal agency to placing it, along with all other health 
services research, in a new, quasi-governmental organization (see also 
Appendix B):
---------------------------------------------------------------------------
    \vi\ Placement, Coordination, and Funding of Health Services 
Research within the Federal Government, AcademyHealth (Sept. 2005). 
Available on the Web at http://www.chsr.org/placementreport.pdf.

          Option 1: AHRQ sponsors and conducts comparative 
        effectiveness studies with oversight and guidance from an 
---------------------------------------------------------------------------
        external board and panel of experts.

          Option 2: AHRQ sponsors and conducts comparative 
        effectiveness studies with oversight and guidance from an 
        external board and panel of experts, and establishes a 
        Federally Funded Research and Development Center 
        (FFRDC).vii The FFRDC would undertake syntheses of 
        research commissioned by AHRQ and others for the purpose of 
        making comparative effectiveness findings.
---------------------------------------------------------------------------
    \vii\ An FFRDC is a private, nonprofit organization that is 
sponsored by an executive branch agency. The sponsoring agency 
monitors, funds, and assumes responsibility for the overall activities 
of the FFRDC. While FFRDCs are not subject to federal personnel rules, 
the organizations are prohibited from competing for government 
contracts to ensure their independence, objectivity, and freedom from 
organizational conflicts of interest.

          Option 3: With AHRQ remaining as currently 
        structured, create a new, separate quasi-governmental entity 
---------------------------------------------------------------------------
        for comparative effectiveness research.

          Option 4: Reconstitute AHRQ as a quasi-governmental 
        entity, retaining most of its existing functions and adding 
        comparative effectiveness research.

    AcademyHealth assessed these four options against five principles 
designed to further guide policymakers' deliberations on comparative 
effectiveness research (see also Appendix C).

          Comparative effectiveness research is a subset of the 
        broader field of health services research, so increased 
        investments in comparative effectiveness research should not be 
        at the expense of investments in a robust health services 
        research portfolio.
          Given the potentially controversial nature of 
        comparative effectiveness findings, this research must be based 
        on scientific evidence and be kept separate from funding and 
        coverage decisions.
          As a subset of the field of health services research, 
        comparative effectiveness research must be closely linked to 
        AHRQ--as the lead agency for health services research--to 
        ensure that findings are consistent with the best available 
        research, methods, and data.
          Since comparative effectiveness research as a public 
        good requires significant federal investment and has the 
        potential to affect the delivery and cost of health care for 
        all Americans, the entity commissioning or conducting this 
        research should be subject to congressional oversight.
          Stakeholders should be involved in developing the 
        research agenda and ensuring the validity of the research 
        produced. Ensuring transparency in the prioritization, conduct, 
        and dissemination of research will promote public acceptance of 
        the research findings and strengthen support for the program's 
        mission.

    The entity's overall funding and ability to recruit the expertise 
needed are critical factors that should inform the choice among these 
options--the best arrangement for a budget of $50 million might not be 
the best if $5 billion were to be made available for this function. It 
may also be desirable to have portions of this responsibility 
undertaken by a combination of entities. Under such a scenario, the 
lead agency for health services research might commission and undertake 
the research studies, an affiliated entity might do the assessments 
based on that research, and an independent quasi-governmental entity 
might develop consensus studies on the methods and data to be used for 
these studies and assessments.
    Regardless of how this research program is structured and governed 
in the future, AcademyHealth and its Coalition recognize that 
comparative effectiveness research will require a significant 
investment to realize its potential. For example, some experts suggest 
that a robust comparative effectiveness program should be funded at a 
level of $4--$6 billion annually to meet the U.S. health system's 
demands. Comparatively, the Federal Government last year spent nearly 
$32 billion on health research, of which only 5 percent--about $1.5 
billion--was apportioned to health services research. The Federal 
Government's comprehensive investment in comparative effectiveness 
research across the various agencies conducting and funding this work 
is unknown, as this information is not systematically collected. 
However, we do know that AHRQ's comparative effectiveness program was 
appropriated $15 million in fiscal 2007 (and $15 million in each of the 
previous three fiscal years).viii,}ix Congress should 
increase and expand the sources of funding for conducting and 
coordinating a wide spectrum of comparative effectiveness research, 
including systematic reviews of existing literature, analysis of 
administrative data and clinical registries, and pragmatic, 
prospective, head-to-head trials. Doing so would ultimately help 
patients, providers, payers, and policymakers make rational choices 
about new and existing health services, and assure that our investments 
in basic and clinical research are integrated into health care 
delivery. After all, increased spending on new medicines and equipment 
is wasted if the system does not adopt these new treatments in a safe 
and efficient manner.
---------------------------------------------------------------------------
    \viii\ Catlin, A., et. al. ``National Health Spending in 2005: The 
Slowdown Continues,'' Health Affairs, Vol. 26, No. 1, pp. 142-153 
(Jan./Feb. 2007).
    \ix\ Federal Funding for Health Services Research, Coalition for 
Health Services Research (Dec. 2006). Available on the Web at http://
www.chsr.org/AHfundingreport1206.pdf.
---------------------------------------------------------------------------
    In addition, we believe that increased investment in comparative 
effectiveness research must be coupled with greater investment in the 
research infrastructure--the data, methods, and researchers needed to 
conduct this work and ultimately generate meaningful research and 
knowledge. The field of health services research has experienced an 
erosion of investment in its methods, data, and particularly its 
researchers over the last several years. If left unchecked, these 
declining investments could threaten the field's capacity to address 
public and private sector research needs.
    In conclusion, the best health care decisions are based on relevant 
data and scientific evidence. Increased investment in comparative 
effectiveness research and the health services research infrastructure 
will show returns in improved quality, accessibility, and 
affordability. At a time when America is spending over $2 trillion 
annually on health care, we need research--now more than ever--to help 
us spend our health care dollars more wisely.
    The Coalition appreciates the opportunity to submit this testimony 
for the record and looks forward to working with the Subcommittee as it 
continues to assess options for structuring and funding a robust 
comparative effectiveness research capability in the United States. If 
you have questions or comments about this testimony, please contact 
Emily Rowe, Director of Government Relations.
Appendix A: Committee on Placement, Funding, and Coordination of Health 
            Services Research within the Federal Government
            (Affiliations at time of committee appointment)

Sheila Burke, Committee Chair, Deputy Secretary and Chief Operating 
Officer, Smithsonian Institution

Jeanne Lambrew, Ph.D., Vice Chair, Associate Professor, Department of 
Health Policy, George Washington University

David Abernethy, Senior Vice President, Operations, HIP Health Plans

Michael Chernew, Ph.D., Professor, Department of Health Management and 
Policy, School of Public Health, University of Michigan

Jordan Cohen, M.D., President, Association of American Medical Colleges

Judith Feder, Ph.D., Dean of Public Policy, Georgetown University

Harold S. Luft, Ph.D., Caldwell B. Esselstyn Professor and Director, 
Institute for Health Policy Studies, University of California, San 
Francisco

Nicole Lurie, M.D., Senior Natural Scientist and Alcoa Chair, RAND 
Corporation

Donald M. Steinwachs, Ph.D., Professor and Chair, Department of Health 
Policy and Management, Bloomberg School of Public Health, Johns Hopkins 
University

Gail Wilensky, Ph.D., Senior Fellow, Project HOPE

             Appendix B: Four Options for the Placement of 
                   Comparative Effectivenss Research

------------------------------------------------------------------------

------------------------------------------------------------- -------------
Option 1: AHRQ sponsors and conducts   AHRQ would
 comparative effectiveness studies     remain the lead agency
 with oversight and guidance from an   for health services
 external board and panel of           research, supporting a
 experts.                              broad health services
                                       research agenda,
                                       including comparative
                                       effectiveness.
                                       AHRQ would
                                       establish an external
                                       board to oversee the
                                       development of the
                                       comparative
                                       effectiveness research
                                       agenda and a panel of
                                       experts to validate
                                       the science used to
                                       conduct comparative
                                       effectiveness studies.
------------------------------------------------------------------------
Option 2: AHRQ sponsors and conducts   AHRQ would
 comparative effectiveness studies     remain the lead agency
 with oversight and guidance from an   for health services
 external board and panel of           research, supporting a
 experts, and establishes a            broad health services
 Federally Funded Research and         research agenda,
 Development Center (FFRDC).           including comparative
                                       effectiveness.
                                       AHRQ would
                                       establish an external
                                       board to oversee the
                                       development of the
                                       comparative
                                       effectiveness research
                                       agenda and a panel of
                                       experts to validate
                                       the science used to
                                       conduct comparative
                                       effectiveness studies.
                                       AHRQ would
                                       also establish an
                                       independent FFRDC with
                                       the limited mission of
                                       reviewing and
                                       synthesizing
                                       comparative
                                       effectiveness
                                       research.
------------------------------------------------------------------------
Option 3: AHRQ remains as currently    AHRQ would
 structured and a new separate quasi-  remain the lead agency
 government entity is established to   for health services
 fund and conduct comparative          research, supporting a
 effectiveness research.               broad health services
                                       research agenda, but
                                       not comparative
                                       effectiveness.
                                       A new quasi-
                                       governmental agency
                                       would be established,
                                       with both public and
                                       private funding, to
                                       conduct both
                                       intramural and
                                       extramural comparative
                                       effectiveness studies.
------------------------------------------------------------------------
Option 4: AHRQ is reconstituted as a   AHRQ
 quasi-governmental agency retaining   reconstituted as a new
 most existing functions and adding    quasi-governmental
 comparative effectiveness research.   entity would conduct
                                       and fund health
                                       services research,
                                       including comparative
                                       effectiveness.
                                       Those AHRQ
                                       functions that must be
                                       performed by a
                                       governmental entity,
                                       such as the Medical
                                       Expenditure Panel
                                       Survey (MEPS), would
                                       be transferred to
                                       other existing HHS
                                       agencies.
                                       The new quasi-
                                       governmental entity
                                       could be supported by
                                       public and private
                                       funds.
------------------------------------------------------------------------

  Appendix C: Five Principles to Guide Decisions for the Placement of 
                   Comparative Effectiveness Research

------------------------------------------------------------------------

------------------------------------------------------------- -------------
Principle 1: Overall funding for the   Recognizes
 field of health services research     that while comparative
 should continue to support a broad    effectiveness research
 and comprehensive range of topics.    is important, it is a
                                       subset of the broader
                                       field of health
                                       services research.
                                       Regardless of
                                       where comparative
                                       effectiveness research
                                       is placed, this
                                       principle stresses the
                                       need to fund a broad
                                       health services
                                       research portfolio.
------------------------------------------------------------------------
Principle 2: Assessments should be     Given the
 based on scientific evidence and      controversial nature
 kept separate from funding and        of comparativeness
 coverage decisions.                   effectiveness
                                       findings, this
                                       principle stresses the
                                       need for a structure
                                       that ensures the
                                       scientific integrity
                                       of comparative
                                       effectiveness
                                       research.
                                       This principle
                                       stresses the need to
                                       separate the entity
                                       that funds and
                                       conducts these studies
                                       from the entity
                                       directly responsible
                                       for making coverage
                                       decisions.
------------------------------------------------------------------------
Principle 3: Entity commissioning or   Recognizes
 conducting comparative                that comparative
 effectiveness research should         effectiveness research
 maintain close linkage to the lead    is a subset of the
 agency for health services            broader field of
 research.                             health services
                                       research.
                                       As such,
                                       comparative
                                       effectiveness research
                                       must be closely linked
                                       to the lead agency in
                                       order to ensure that
                                       findings are
                                       consistent with the
                                       best available
                                       research, methods, and
                                       data.
------------------------------------------------------------------------
Principle 4: Entity commissioning or   Since
 conducting comparative                comparative
 effectiveness research should be      effectiveness research
 subject to congressional oversight.   has the potential to
                                       affect the delivery
                                       and cost of health
                                       care for all
                                       Americans, this
                                       principle recognizes
                                       that the Federal
                                       Government is
                                       responsible for
                                       ensuring that
                                       decisions about what
                                       health services and
                                       products should be
                                       provided are based on
                                       sound scientific
                                       research.
                                       Since this
                                       research requires
                                       substantial federal
                                       funding (and would not
                                       be funded adequately
                                       by the private sector
                                       alone), this principle
                                       recognizes the need
                                       for appropriate
                                       congressional
                                       oversight of public
                                       funding to ensure
                                       accountability.
------------------------------------------------------------------------
Principle 5: Entity commissioning or   Given the
 conducting comparative                controversial nature
 effectiveness research should         of comparative
 involve key stakeholders to assure    effectiveness
 transparency of the methods and       research, this
 process, promote public acceptance    principle recognizes
 of research findings, and support     the importance of
 for the entity's mission.             involving key private
                                       sector representatives
                                       in developing the
                                       research agenda and
                                       ensuring the validity
                                       of the research
                                       produced, thereby
                                       increasing public
                                       support for the
                                       research findings and
                                       the entity's mission.
                                       As such,
                                       comparative
                                       effectiveness research
                                       must be funded in an
                                       open process to ensure
                                       that no one group is
                                       perceived as
                                       dominating the process
                                       and/or skewing the
                                       results.
------------------------------------------------------------------------


                                 

                                                Epilepsy Foundation
                                           Landover, Maryland 20785
                                                       July 9, 2007

Chairman Pete Stark
House Ways and Means Health Subcommittee
1135 Longworth House Office Building
Washington, DC 20515

Dear Chairman Stark,

    On behalf of the Epilepsy Foundation and the more than 3 million 
Americans living with epilepsy, I am pleased to submit the following 
comments in response to the Health Subcommittees' June 12, 2007 hearing 
on Strategies to Increase Information on Comparative Clinical 
Effectiveness.
    The Epilepsy Foundation applauds the Committee's intent to address 
the issue of rising health care costs and the lack of evidence 
justifying extreme variations in the provision of medical services. We 
recognize many of the potential benefits to increasing, and making 
available, information on the relative effectiveness of health care 
services.
    Yet we are also concerned that this information not be based solely 
on the limited perspective of random clinical trials and that the 
application of Comparative Clinical Effectiveness not be based upon, or 
utilized, for cost containment benefits only.
    Epilepsy is a chronic neurological condition characterized by 
recurrent seizures. Individuals with epilepsy are at a two--to three-
fold increased risk of death, as well as an increased risk of cognitive 
impairments, employment difficulties and personal isolation (due in 
part to the social stigmas associated with this 
condition).i,}ii,}iii,}iv,}v,}vi,}vii,}viii Each year, 
approximately 200,000 individuals in the United States are newly-
diagnosed with epilepsy.ix Although initial onset can occur 
at any age, epilepsy most commonly arises in either early childhood or 
old age.x
---------------------------------------------------------------------------
    \i\ Cockerell OC, Johnson AL, Sander JW, Shorvon SD. Prognosis of 
Epilepsy: A Review and Further Analysis of the First Nine Years of the 
British National General Practice Study of Epilepsy, a Prospective 
Population-Based Study. Epilepsia. 1997; 38(1):31-46.
    \ii\ Hauser WA, Annegers JF, Elveback LR. Mortality in patients 
with epilepsy. Epilepsia. 1980;21:399-412.
    \iii\ Olafsson E, Hauser WA, Gudmundsson G. Long-Term Survival of 
People with Unprovoked Seizures: A Population Based Study. Epilepsia. 
1998;39:89-92.
    \iv\ Zielinski JJ. Epilepsy and Mortality Rate and Causes of Death. 
Epilepsia. 1974;15:191-201.
    \v\ Nilsson L, Tomson T, Farahmand BY, Diwan V, Persson PG Cause-
Specific Mortality in Epilepsy: A Cohort Study of More Than 9,000 
Patients Once Hospitalized for Epilepsy. Epilepsia. 1997;38(10):1062-8.
    \vi\ Motamedi G, Meador K. Epilepsy and cognition. Epilpesy Behav. 
2003;4(Suppl. 2):25-38.
    \vii\ Fisher RS, Vickrey BG, Gibson P, Hermann B, Penovich P, 
Scherer A, Walker S. The impact of epilepsy from the patient's 
perspective I. Descriptions and subjective perceptions. Epilepsy Res. 
2000;41:39-51.
    \viii\ Sillanpaa M, Jalava M, Kaleva O, Shinnar S. Longer-Term 
Prognosis of Seizures with Onset in Childhood. N. Engl. J. Med. 
1998;338:1715-22.
    \ix\ Epilepsy Foundation. Epilepsy and Seizure Statistics. 
Available at: http://www.epilepsyfoundation.org/about/. Accessed on 
April 19, 2007.
    \x\ Centers for Disease Control and Prevention. Living Well with 
Epilepsy, Report of the 2003 National Conference on Public Health and 
Epilepsy. Available at www.cdc.gov/Epilepsy/pdfs/living_well_2003.pdf. 
Accessed on January 10, 2007.
---------------------------------------------------------------------------
    Modern treatment of epilepsy relies primarily on the use of one or 
more antiepileptic drugs (AEDs) with the goal of preventing 
seizures.xi Other treatment options may include surgery, 
special diet and/or the use of a device to stimulate the vagus nerve.
---------------------------------------------------------------------------
    \xi\ Sander JW. The Use of Antiepileptic Drugs--Principles and 
Practice. Epilepsia. 2004;45(Suppl. 6):28-34.
---------------------------------------------------------------------------
    Complete prevention of seizures remains elusive in approximately 
one in three patients with epilepsy. In these patients, the goal of 
treatment is to minimize the frequency and intensity of the seizures 
without unacceptable side effects from treatment. Epilepsy, and 
treatment to control seizures, is not a one size fits all condition. To 
manage patients with epilepsy effectively, patients need access to the 
full range of treatment options and physicians must tailor treatment 
for each patient to achieve maximum control of seizures while 
minimizing adverse side effects.xii,}xiii,}xiv,}xv,}xvi
---------------------------------------------------------------------------
    \xii\ EUCARE. European white paper on epilepsy: Pharmacological 
Treatment. Epilepsia 2003;44(Suppl. 6):33-4.
    \xiii\ Stokes T, Shaw EJ, Juarez-GA, Camosso-Stefinovic J, Baker R. 
Clinical Guidelines and Evidence Review for the Epilepsies: diagnosis 
and management in adults and children in primary and secondary care. 
Royal College of General Practitioners, London England. 2004. Link 
available at: http://www.nice.org.uk/guidance/CG20. Accessed on January 
23, 2007.
    \xiv\ Glauser T, Ben-Menachem E, Bourgeois B, Cnaan A, Chadwick D, 
Guerreiro C, Kalviainen R, Mattson R, Perucca E, Tomson T. ILAE 
Treatment Guidelines: Evidence-based Analysis of Antiepileptic Drug 
Efficacy and Effectiveness as Initial Monotherapy for Epileptic 
Seizures and Syndromes. Epilepsi. 2006;47(7);1094-1120.
    \xv\ French JA, Kanner AM, Bautista J, Abou-Khalil B, Browne T, 
Harden CL, Theodore WH, Bazil C, Stern J, Schachter SC, Bergen D, Hirtz 
D, Montouris GD, Nespeca M, Gidal B, Marks Jr. WJ, Turk WR, Fischer JH. 
Bourgeois B, Wilner A, Faught Jr. RE, Sachdeo RC, Beydoun A, Glauser 
TA. Efficacy and tolerability of the new antiepileptic drugs I: 
Treatment of new onset epilepsy: Report of the Therapeutics and 
Technology Assessment Subcommittee and Quality Standards Subcommittee 
of the American Academy of Neurology and the American Epilepsy Society. 
Neurology. 2004;62:1252-60.
    \xvi\ French JA, Kanner AM, Bautista J, Abou-Khalil B, Browne T, 
Harden CL, Theodore WH, Bazil C, Stern J, Schachter SC, Bergen D, Hirtz 
D, Montouris GD, Nespeca M, Gidal B, Marks Jr. WJ, Turk WR, Fischer JH. 
Bourgeois B, Wilner A, Faught Jr. RE, Sachdeo RC, Beydoun A, Glauser 
TA. Efficacy and tolerability of the new antiepileptic drugs II: 
Treatment of refractory epilepsy: Report of the Therapeutics and 
Technology Assessment Subcommittee and Quality Standards Subcommittee 
of the American Academy of Neurology and the American Epilepsy Society. 
Neurology. 2004;62:1261-73
---------------------------------------------------------------------------
    As the discussion of Comparative Clinical Effectiveness moves 
forward the Foundation encourages that, throughout the process, two key 
principles be applied.
1. Evidence being considered and applied should be broad and inclusive.
    While a comprehensive, and inclusive, approach to comparative 
clinical effectiveness and, in turn, evidence based healthcare can 
indeed lead to high quality healthcare and maximize patient outcomes, a 
limited approach, we fear, would limit access and, in turn, not offer 
people with epilepsy, and others living with chronic disorders, the 
optimal care that is available.
    To assure a comprehensive approach to the topic of comparative 
clinical effectiveness the Epilepsy Foundation supports a model that 
encompasses a broad definition and application of what is accepted as 
``evidence''. The Foundation feels strongly that treatment selection be 
based on a combination of scientific research, physician expertise and 
experience, and the patient's preferred outcomes, preferences and 
expectations.
    We are fearful that a ``one-size-fits-all'' approach to treatment 
can result from strict reliance on ``evidence'' solely from random 
clinical trails and published studies that do not take into account 
diverse populations, co-morbidities, and other real world situations.
12. The process should be transparent and include consumer/patient 
        involvement.
    As decisions are made as to the structure, funding, and utilization 
of a comparative effectiveness entity we encourage that consumers/
patients be considered a primary stakeholder and participant at every 
level.
    We anticipate transparency and public comment periods will be 
included throughout the process and that patients/consumers will be 
encouraged to provide input. The Foundation would like to see that 
outreach to, and participation by, consumers/patients will encourage 
and empower them to be involved in research design, review and 
translation, dissemination, implementation and evaluation. Undoubtedly, 
government, researchers, funders, industry and payors will all play a 
critical role. Each entity should strive to include the patient 
perspective and involvement in their work on this issue.
    Recognizing the importance of the patient perspective in this on-
going discussion, in early 2006 the Epilepsy Foundation became a 
founding member of the National Working Group on Evidence-Based Health 
Care. This group, comprised of consumers, caregivers, practitioners and 
researchers, is committed to promoting accurate and appropriate 
evidence-based policies. Information about this group, and our work, 
can be found at www.evidencebasedhealthcare.org.
    Again, the Epilepsy Foundation is grateful for the opportunity to 
provide these comments to the dialogue on comparative clinical 
effectiveness and welcomes the opportunity to be a continuing resource 
and participant in this evolving issue. For additional information, or 
if we can be of further assistance, please feel free to contact me.

            Sincerely,

                                              Donna Meltzer
                            Senior Director of Government Relations

                                 

                   Statement of Mental Heath America
    Mental Health America (formerly the National Mental Health 
Association) is the country's leading nonprofit dedicated to helping 
ALL people live mentally healthier lives. With our more than 320 
affiliates nationwide, we represent a growing movement of Americans who 
promote mental wellness for the health and well-being of the nation--
everyday and in times of crisis.
    We applaud the Subcommittee on Health, Committee on Ways and Means 
of U.S. House of Representatives for holding a hearing to increase 
information on Comparative Clinical Effectiveness on June 12, 2007. We 
are encouraged by the new proposals to expand Comparative Clinical 
Effectiveness efforts and improve the overall quality and value of 
health care delivery in our country.
    Mental Health America has followed the current national healthcare 
reform debate and witnessed the balancing act between access to safe 
and effective health care, cost and quality. In this environment of 
steadily rising costs, Mental Health America is concerned that the 
evaluation of ``quality'' of care is being used as a means of 
justifying cost-based decisions about the types and quantity of health 
services available. At every level of the debate--federal, local, 
public and private--the stakes are high for how this will impact access 
to care, particularly for vulnerable Americans who are reliant on 
public systems to get basic care for chronic health conditions, such as 
mental illnesses. Mental Health America is particularly concerned with 
how these trends will impact the Medicaid program as well as the public 
mental health system in this country.
    As these deliberations continue to unfold, Mental Health America 
offers the following comments for the Committee's consideration:

          Promoting patient/consumer inclusion: The current comparative 
        clinical effectiveness proposals seek to influence and reform 
        health care delivery in the best interest of the patient. 
        However, these efforts often lack a balanced representation of 
        the very stakeholders for whom these decision will be most 
        important, patients/consumers. Decision makers must recognize 
        the importance of including patients/consumers as partners at 
        every stage of comparative clinical effectiveness efforts 
        including: research design, review, evaluation and governing 
        bodies that make decisions about how to apply evidence in 
        practice and policy. The process to evaluate and develop 
        evidence-based interventions, treatments and policies should be 
        transparent and open to the public and include all stakeholders 
        in the decision making process. Consumers and families should 
        have active and meaningful roles on review, evaluation and 
        governing bodies that make decisions about how to apply 
        evidence in practice and policy. In addition, clear and 
        complete research findings should be communicated to consumers 
        and families, and tools and practices should be developed to 
        aid consumers in how to use such information in their dialogue 
        with caregivers.

          Preserving access to individualized care: Scientific and 
        practical evidence can aid in determining what is the best 
        intervention to optimize an individual's care, but such 
        evidence alone cannot guarantee the right choice for every 
        individual. Therefore, it is important that reimbursement and 
        coverage policies reflect the need for individualized care and 
        maintain flexibility for clinicians and individuals to access a 
        range of treatments and services. In addition, it is important 
        to advocate for wider investment in practical clinical trials 
        and other research methods that generate evidence applicable to 
        real-world treatment settings.

          Promoting quality health care first: The underlying 
        motivation of these initiatives is cost containment rather than 
        improving quality of care. Safety and optimal treatment for the 
        individual should be the overriding goal of any comparative 
        clinical effectiveness approach. Treatment costs are relevant 
        to the discussion but must be weighed in the system context--
        total care costs for an individual across services and 
        settings--rather than as unit costs. In the context of clinical 
        decision making, cost should be evaluated by providers and 
        consumers after a careful weighing and discussion of benefits 
        and risks and a dialogue that emphasizes choice across a range 
        of therapeutic options. Mental Health America opposes processes 
        and policies that emanate solely from cost containment 
        objectives. Moreover, our organization opposes the misuse of 
        the concept of evidence or the findings from comparative 
        clinical effectiveness initiatives as a justification for 
        denial of coverage, reimbursement or access to care except in 
        areas where significant safety concerns are identified.

          Identifying and addressing gaps in research: The boundaries 
        of scientific research are stretching and revealing new 
        understanding and options for treating many chronic illnesses, 
        including mental health conditions. Even as emerging science 
        gives us information about how and why mental illnesses affect 
        individuals, and about genetic biomarkers that may better guide 
        treatment choices, it also reveals the absence of universally 
        effective treatments and practices and the limitations to the 
        current body of scientific evidence in mental health. We 
        believe there are limitations of clinical research design--
        particularly the ``gold standard'' of randomized controlled 
        trials--which do not effectively measure important outcomes, 
        such as quality of life, employment, relationships, and the 
        impact of side effects of different treatments. Realities of 
        the individual consumer (age, gender, ethnicity, co-occurring 
        disorders, and treatment goals and preferences) often are not 
        captured as part of this research. Mental Health America 
        supports the role of all levels of evidence--including 
        randomized clinical trials, quasi-experimental studies, 
        observational studies and expert consensus--in creating the 
        evidence base for an intervention or service.

    Our abovementioned comments mirror those to which we have submitted 
to Oregon's Drug Effectiveness Review Project and the Agency for 
Healthcare Research and Quality's Effective Health Care program. 
Attached are two documents that Mental Health America submitted to 
Oregon's Drug Effectiveness Review Project which include comments to 
their reports on atypical antipsychotics and second generation 
antidepressants. These documents illustrate in further detail the 
concerns we have in using comparative clinical effectiveness approaches 
and caution state leaders regarding the limitations of applying this 
information to public policy decision making.
    We hope you take into consideration our views and thank you again 
for this opportunity to comment.

                               __________

                              Attachment A
NMHA Comments on the

Draft Drug Class Review for Atypical Antipsychotic Drugs--Update 1

March 14, 2006

    Thank you for the opportunity to respond to the draft drug class 
review on pharmacologic treatments for atypical antipsychotic (AAP) 
medications. We appreciate that you have continued to update and review 
your conclusions. We commend DERP for its inclusion of the CATIE study 
in this review and we are most pleased to see that you chose to include 
information about limitations of the research and addressed some of our 
previous concerns.
    However, the review still highlights the desperate need for better 
research on both the efficacy and the effectiveness of these 
medications and points to the ongoing necessity for caution when states 
and private companies develop pharmacy policies based on limited 
information. On page 13, the review acknowledges that ``quality of the 
evidence on effectiveness is a key component, but not the only 
component, in making decisions about clinical policies.'' NMHA 
continues to encourage the Oregon Center to communicate to its 
participating agencies and on its website that the Drug Effectiveness 
Review Project needs to be used within a larger context of policy 
decision-making. Below NMHA has additional questions and comments about 
the review.
Overall Inadequate Research
    As with previous reviews of atypical antipsychotic medications, 
this review found that the research is generally inadequate to draw 
appropriate conclusions about which atypical antipsychotic medications 
work for different individuals. Comments from the CATIE principle 
investigator Dr. Jeffrey Lieberman reinforce this notion. During the 
National Institutes of Mental Health (NIMH) briefing on September 26, 
2005, Dr. Lieberman stated, ``The outcomes show that Schizophrenia 
patient choices must be individualized. What works for one individual 
may not work for another.''
    Furthermore, the CATIE data is presently incomplete. Only Phase 1 
data has been released. Further analysis and more detailed evaluation 
of study findings are forthcoming. It is important to note that CATIE 
study researchers and NIMH Director Dr. Thomas Insel have said that it 
would be counterproductive for anyone to use this data to reduce access 
and that it would be ``premature to change public policy on the basis 
of this study.''
    This lack of data makes it very difficult for policymakers, 
researchers, and others to draw any conclusions about the comparative 
effectiveness of these medications. We strongly urge DERP to clarify in 
its review that a general lack of evidence about differences does not 
mean that there are no differences between the medications.
    On page 18, the DERP review reports that only 3 effectiveness 
trials were identified and reviewed for comparative effectiveness and 
short term adverse events of AAPs in patients with Schizophrenia. Yet 
in the review, it states that the results of effectiveness studies are 
more applicable to the ``average'' patient than results from highly 
selected populations in efficacy studies. The review states, ``The 
remainder of the direct evidence comes from efficacy trails, which 
include narrowly defined patient populations, and are not conducted 
within the context of a care system with the typical range of co-
interventions and/or co-morbidities, and a small number of studies with 
observational designs. The generalizability of the findings of the 
efficacy studies to broader groups of patients and setting is 
limited.'' We are very concerned by this finding, especially because it 
limits stakeholders' abilities to use the review for policymaking 
decisions. We encourage DERP to make a call for more research within 
the review and to offer reasons why this lack of data is important for 
policymakers.
    In addition, on page 20, the DERP review states, ``There is very 
limited evidence regarding AAPs used for the treatment of schizophrenia 
in subgroup populations.'' We are very concerned about the lack of 
research focused on differences in responses by people of different 
genders, race and ethnicity. Again, we encourage DERP to use this 
review to call for more research in this area and to look at other 
sources of information that addresses this important issue.
Adverse Events
    We noted the review did find that patients appeared to have 
significant differences in tolerability of side effects and other 
adverse events. This is a critically important area, and is believed to 
be strongly linked with patients continuing with certain medications. 
We strongly recommend highlighting this finding in the introduction as 
well as conclusion of the report.
    Finally, the information organized is one piece in a complex puzzle 
of making healthcare decisions. As state policymakers face difficult 
choices in an environment of increasing healthcare costs, we are 
concerned that this information will become political cover for 
establishing policies that will harm the health of vulnerable citizens. 
We recommend that the following guidance be shared with participating 
agencies and be featured prominently in the reviews and in your cover 
letters:

          Please note that the information organized in the 
        drug class reviews is an important part of making decisions 
        about the effectiveness of this class of medications, but it 
        should not be the sole source of making such decisions. The 
        Oregon Center recommends that treatment guidelines, clinical 
        experience, and consumer input be also included in any pharmacy 
        management programs.
          The Oregon Center urges participating agencies to 
        work with consumer and provider groups to assess what 
        medications work best in clinical practice, and to ensure that 
        adequate choices are available in participating agency's 
        pharmacy programs. All pharmacy policies should be voluntary to 
        provide flexibility to the physician and the patient.
          All pharmacy policies should contain several choices 
        of medications to accommodate different responses to 
        medications, including different adverse responses or differing 
        responses based on gender, race, or ethnicity.

                               __________

                              Attachment B
NMHA Comments on the Draft Drug Class Review for Second Generation 
    Antidepressants

July 19, 2006

    On behalf of the National Mental Health Association (NMHA), thank 
you for the opportunity to respond to your draft drug class review on 
pharmacologic treatments for second generation antidepressants.
    We applaud the Drug Effectiveness Review Project (DERP) for 
acknowledging on page 5 that, ``The tremendous volume and large 
variability in the quality of evidence to support use of these products 
makes it difficult for clinicians and decision makers to make evidence-
based decisions.'' This acknowledgment supports our concern of the 
limitations of the scope and power of existing scientific research. 
Below NMHA has additional comments about the review.
Effectiveness studies are lacking
    We note that the report comments on the limited number of studies 
that review effectiveness of the compared medications. While we 
recognize this general weakness in scientific research, we are 
surprised that DERP then concludes that it can comment on the 
comparative effectiveness of these medications. Based on the fact that 
an inadequate sample of such studies is presented in the report, we 
urge DERP to comment prominently that such conclusions cannot be drawn 
based on the available evidence.
    Furthermore, of particular concern is the dearth of research on 
quality of life measures as stated on page 16, ``Quality of life and 
functional capacity were rarely assessed, and if they were, they were 
considered only as a second outcome.'' These measures greatly impact a 
patient's satisfaction with and adherence to a particular medication 
and should be weighed equally to measures of efficacy and symptom 
reduction. By including these measures, patients, physicians, payers 
and decision makers will receive a more accurate picture of how 
effective or ineffective a particular medication is.
Limited data on subgroups
    The conclusions that were drawn from this report are generalized to 
subgroups which were not included in many of the studies that were 
reviewed. For example on page 28, the review states, ``We did not find 
any evidence that one group has a greater benefit from an individual 
drug than another.'' Yet we noticed that very little research focused 
on differences in responses by people of different genders or racial 
and ethnic minorities and for people with co morbid health conditions.
    Furthermore, the report acknowledges on page 17 that, ``Most 
studies received a fair rating for internal validity. The 
generalizability of the results was hard to determine and might often 
be limited.''
    While we appreciate DERP's recognition of this issue, these 
conclusions affirm what we know exists in the scientific research 
today. Given this lack of data, however, we call on DERP to prominently 
note that conclusions about response to second generation 
antidepressants among subgroups is ``inconclusive'' rather than the 
current conclusion that evidence shows ``no differences.'' Again, this 
clarification will highlight that the evidence base is insufficient to 
allow conclusions to be drawn that emphasize the need for 
individualized care choices.
    The information about scientific evidence that DERP presents in 
this report is one piece in a complex puzzle of informing and improving 
healthcare decisions. While NMHA is committed to promoting high quality 
mental health care that is informed by the best scientific evidence 
available, we continue to be concerned at the local application of 
reports similar to DERP's as a rationale for limiting choice of care to 
one or two agents, or requiring that individual's fail on the preferred 
(cheapest) medication before being allowed to choose from more 
(possibly) therapeutically appropriate choices.

          As DERP prepares the final report, we urge you to 
        feature prominently the following key messages:

                  Clarify that the information organized in this 
                report is one component in making decisions about the 
                effectiveness of second-generation antidepressants; it 
                should not be the sole source of making such decisions 
                on a clinical or policymaking level.
                  Urge private and public policymakers and payers 
                to work with consumer and provider groups to 
                incorporate scientific evidence with knowledge from 
                clinical practice and from patient viewpoints and 
                values.

          Make prominent the message that evidence that no 
        significant differences exist within this class of medications 
        does NOT imply that:

                  All medications are identical
                  None of the medications are efficacious in 
                treating depression.
                  Call for more research in primary care 
                populations, for subgroups, and for effectiveness 
                research for treatment of depression that includes 
                measure of functionality and patient preference.
                  Clearly state that current evidence on second-
                generation antidepressants does not provide clear 
                justification for policies that limit choice of 
                medication because existing evidence affirms that 
                different therapies are efficacious for different 
                individuals.

    NMHA continues to encourage the Oregon Center to communicate with 
its participating agencies and on its website that the DERP needs to be 
used within a larger context of policy decision-making.
    If you have any questions, please contact Jennifer Bright, Vice 
President for state policy.

                                 

   Statement of the National Alliance on Mental Illness, Arlington, 
                                Virginia
    Chairman Stark and Congressman Camp, on behalf of the National 
Alliance on Mental Illness (NAMI) I am pleased to offer the following 
statement on strategies for increasing information comparative clinical 
effectiveness. As the nation's largest organization representing people 
with serious mental illness and their families--210,000 members and 
1,200 affiliates in all 50 states--I am pleased to offer our views on 
this important issue.
    NAMI feels strongly that comparative effectiveness research can 
serve as an important source of information that contributes to both 
medical care decision-making between patients and providers, as well as 
decisions about coverage and reimbursement. In addition to such 
research, expert clinical guideline development, review of patient 
registries and existing claims and utilization data, health services 
research, disease management strategies, and e-health initiatives all 
have a role in supporting better real-time decisions with a focus on 
the individual patient/consumer.
    NAMI is a member of the National Working Group on Evidence-Based 
Healthcare, a coalition of patient and chronic disease advocacy 
organizations that is working to ensure that comparative effectiveness 
research plays the most appropriate role in our health care system. 
NAMI concurs that the focus of comparative effectiveness research must 
be on health conditions and chronic illness broadly, rather than 
narrowly focused on particular healthcare technology. This will allow a 
more useful analysis of all available approaches and a comparison of 
risks and benefits that will be most relevant and useful to the end 
user--patients and their families. It is also important that updates of 
such research must be frequent to ensure that new evidence is rapidly 
disseminated to clinicians and patients/consumers.
    NAMI would like to commend the Agency for Healthcare Research and 
Quality (AHRQ) for its pursuit of transparent and inclusive processes 
to prioritize, conduct and disseminate the findings from its systematic 
reviews in the Effective Healthcare program. NAMI, along with many of 
our colleagues in the National Working Group on Evidence-Based 
Healthcare, have participated in public forums, offered comments on 
priority setting, key questions for the reviews, and draft reviews and 
participated in review of dissemination materials from the Eisenberg 
Center. These interactions have been positive and we have seen efforts 
to incorporate recommendations and concerns into final products.
    It should be noted however that this positive experience with AHRQ 
is in contrast to NAMI's experience with other organizations involved 
in such work, such as the Drug Effectiveness Review Project (DERP) and 
Consumers' Union. While the DERP's processes have recently improved, 
the organization has been resistant to wider transparency and inclusive 
processes that incorporates meaningful input from patient advocacy 
groups. This has been coupled with an absence of focus on methods of 
dissemination that promote dialogue with all stakeholders to ensure a 
balanced consideration of issues related to implementation in policy 
decision-making.
    DERP reviews in turn have been used to inform the work of 
Consumers' Union's Best Buy Drugs program, which seeks to inform 
consumers--principally by their own definition consumers without health 
coverage or with high pharmaceutical costs--about both comparative 
clinical effectiveness and cost-effectiveness. The Consumers' Union 
program too often portrays choices for consumers in an overly-
simplistic and potentially misleading way. While there are disclaimers 
on the site that consumers should not discontinue medications and that 
individual's response to medications will vary, the notion of 
identifying ``best buys'' leads to a conclusion that there is a choice 
that will fit the majority of the audience.
    In fact, there is overwhelming evidence that in the case of 
medications to treat mental illness, individual response to medications 
will vary based on age, gender, race/ethnicity, health status, co-
occurring health conditions--details which are absent from the Best Buy 
literature. Further, NAMI is extremely concerned about the lack of 
inclusion of chronic disease and patient advocacy organizations in the 
development of Best Buy products. Such exclusion--even omitting public 
comment periods that could ensure relevance to their audience--is 
misguided in an environment where all stakeholder opinions must given 
consideration.
    As with our colleagues in the National Working Group on Evidence-
Based Healthcare, NAMI offers no specific recommendation on where an 
entity conducting comparative effectiveness research should be placed, 
we do urge policymakers to avoid seeking to reinvent processes or 
organizational entities. Instead, it is important to emphasize the need 
for an inclusive and broadly-representative partnership between 
government, private entities, providers, as well as patients and their 
families.
    NAMI also has concerns about any entity that places payor and 
private-stakeholder entities in leadership roles without adequate 
balance from clinical and chronic disease and patient representation. 
It is critical that the voice of Americans living with chronic diseases 
and their families have meaningful and varied representation on 
government bodies, advisory groups and other mechanisms to assure a 
diverse voice. This is in contrast to current bodies organized around 
evidence-based medicine in which a select few organizations are 
representing the global consumer perspective.
    NAMI shares the views of the National Working Group on Evidence-
Based Healthcare Working Group in urging that cost-effectiveness NOT be 
part of any review of comparative clinical effectiveness. The 
consideration of cost factors can sometimes be important to inform 
clinical and consumer decision-making. However, this analysis of cost-
effectiveness must be separate and subsequent to analysis of clinical 
value. This is a necessary separation to emphasize the focus on quality 
of healthcare rather than cost first. Cost-effectiveness analysis is 
even more complex and controversial in terms of reflecting stakeholder 
values, thus potentially further politicizing any conduct of 
comparative effectiveness analysis.
    NAMI agrees strongly that there is tremendous risk in comparative 
effectiveness research being used as a blunt policy instrument for cost 
control. It is troubling that groups as respected as the Congressional 
Budget Office (CBO) have articulated the misguided notion that such 
research can provide a simplistic and objective decision about the best 
choices of therapeutic interventions for every individual. Restrictions 
on patient and clinician choice of therapies in state Medicaid programs 
and in Medicare Part D drug plans demonstrate the potential for 
inappropriate application of comparative effectiveness research to 
coverage decisions, particularly for high-cost chronic health 
conditions. These approaches fail to recognize and support 
individualized care decisions and imply ``population based'' solutions 
to complex individual health conditions.
    NAMI shares the view of the National Working Group on Evidence-
Based Healthcare that comparative effectiveness research is only as 
good as the measures and populations that are included in the research 
being compared and synthesized. Its applicability to a specific 
individual or a particular circumstance may be significantly limited. 
Within a cost containment framework, studies that demonstrate similar 
average outcomes on a limited number of targets can provide a rationale 
for limiting treatment choices. In reality, differences between people 
in their response to treatment and multifaceted outcomes that often 
accompany the management of chronic illnesses confound this logic.
    NAMI is encouraged that you and your colleagues in Congress, 
including Representative Tom Allen, are open to suggestions about how 
to ensure that HR 1184 incorporates protections to ensure patients and 
consumers have access to all options for care. We share his view that 
comparative effectiveness research be an informant rather than a driver 
of healthcare decisions. Full participation of patients and families in 
every aspect of comparative effectiveness research is critically 
important and consistent with the historical tenets of evidence-based 
medicine that balance research, clinical expertise with patient 
perspectives and preferences.
    Thank you for the opportunity to share NAMI's views on this 
important issue.

                                 

    Statement of Pharmaceutical Research and Manufactures of America
    The Pharmaceutical Research and Manufacturers of America (PhRMA) 
appreciates the opportunity to comment on comparative effectiveness 
research and its role in improving the health care patients receive. 
PhRMA supports the development and use of high quality evidence, 
including comparative effectiveness evidence, for health care decision-
making. Development of high quality evidence can support physicians' 
and patients' treatment decisions, consumers' decisions about health 
plans and benefit designs, and health plans' policy decisions. 
Proposals for expanding government-supported comparative effectiveness 
research should be structured to promote better patient health rather 
than to deny or delay patients' access to beneficial care, as occurs in 
Europe and Australia.
    PhRMA has previously issued principles on evidence-based medicine 
and health outcomes research (attached), which encompass comparative 
effectiveness research. Consistent with these principles, programs for 
government-supported research should:

          Recognize and support the central role of the 
        physician and patient in treatment decision-making;
          Provide information to support good decision-making; 
        government or quasi-governmental organizations supporting 
        comparative effectiveness research should not make coverage 
        recommendations or decisions;
          Improve quality of patient care by identifying and 
        supporting approaches to making better use of the evidence we 
        already have about what works in health care;
          Support research to close evidence gaps across the 
        health care system, including care management, health benefit 
        and delivery designs, and the full range of treatments;
          Encourage pluralistic approaches that provide for 
        multiple organizations to generate and evaluate evidence in 
        patient-centered, clinically sensitive ways;
          Reflect emerging use of genomic, health information 
        technology, and other advances (``personalized medicine'') to 
        tailor treatment decisions;
          Draw on a full range of evidence, including evidence 
        on patient reported outcomes and consider both direct benefits 
        and broader indirect benefits that are important to society, 
        such as quality of life, patient functionality and economic 
        productivity;
          Utilize open, transparent, patient-centered processes 
        for setting research priorities, conducting research, and 
        applying and communicating findings; and
          Ensure effective, balanced communication of results, 
        including disclosure of the limitations of the findings.

    PhRMA recognizes the value of expanding the amount of available 
evidence for health care decision-making. We also believe research on 
how to make better use of the evidence we already have about what works 
in health care needs to be an equally prominent part of any new 
effort's agenda. This latter type of work likely has the greatest 
potential to improve both outcomes and efficiency. For instance:

          A National Institutes of Health official has pointed 
        out that if all heart patients were treated according to 
        current guidelines, heart disease would no longer be the 
        nation's number one killer.\1\
---------------------------------------------------------------------------
    \1\ Statement by Dr. Claude Lenfant, Director National Heart, Blood 
and Lung Institute. Dateline NBC. 21 May 2001.
---------------------------------------------------------------------------
          Physician organizations have pointed out that there 
        are treatments known to effectively control diabetes, yet many 
        patients do not receive them.\2\
---------------------------------------------------------------------------
    \2\ Agency for Health Care Quality and Research. Closing the 
Quality Gap: Diabetes Care Strategies. April 2004.
---------------------------------------------------------------------------
          A 2007 study in the journal Health Affairs estimates 
        that if all patients with hypertension were treated to 
        guideline, 89,000 premature deaths and 420,000 hospitalizations 
        could be avoided annually--in addition to the 86,000 premature 
        deaths and 8333,000 hospitalizations for heart attack and 
        stroke already avoided.\3\
---------------------------------------------------------------------------
    \3\ D. Cutler, et al. The Value Of Antihypertensive Drugs: A 
Perspective On Medical Innovation Health Affairs, January/February 
2007; 26(1): 97-110.

    Research that determines how to close these and many other known 
gaps between what we already know and the care patients receive is a 
priority that needs to be included in any new health research 
initiative.
    As part of this integrated approach, programs for comparative 
effectiveness research should include research to develop comparative 
evidence on care management approaches and benefit designs that ensure 
delivery of high quality care, rather than being limited to treatments 
and services. This broad agenda is defined in current statute (Sec. 
1013 of the Medicare Modernization Act) but has yet to be fully 
implemented. The importance of pursuing this portion of the agenda is 
evident in recent reports of forward-looking employers who have 
achieved better health outcomes and savings by modifying their health 
benefit designs in ways that promote access to treatment for several 
chronic conditions, rather than by restricting access.\4\ Likewise, 
academic studies have pointed to the importance of benefit design in 
determining health outcomes and costs.\5\
---------------------------------------------------------------------------
    \4\ Milt Freudenheim. To Save Later, Employers Offer Free Drugs 
Now, The New York Times, 21 February 2007.
    \5\ A. Chandra, Harvard University, et al., ``Patient Cost-Sharing, 
Hospitalization Offsets, and the Design of Optimal Health Insurance for 
the Elderly,'' NBER Working Paper Series, Working Paper 12972, March 
2007.
---------------------------------------------------------------------------
    In addition, as the Committee considers expanding the government's 
role in comparative effectiveness research, it should ensure that the 
research questions that are relevant to patients, physicians and other 
health care providers are given a high priority. Having an open, 
patient-centered process for setting research goals and allowing 
patient and provider voices to be heard will ensure that comparative 
research benefits patients and providers.
    PhRMA and our member companies are engaged in a number of 
activities to strengthen the field of comparative effectiveness 
research and enhance the evidence base. However, we also believe more 
can be done to strengthen the field of comparative effectiveness 
research and strengthen our health care evidence base.
    While supporting steps to expand evidence on comparative 
effectiveness, we also recognize that this type of evidence can be 
misapplied as a blunt cost control tool through ``one size fits all'' 
coverage or payment policies. Physician and patient experience, a 
growing body of research, and the emerging science of molecular 
medicine all show why one size almost never fits all in medicine. 
Comparative effectiveness research should be used in ways that reflect 
differences in patient response to treatment and differences in 
individual clinical needs and preferences, and enable physicians to 
tailor treatment for the individual based on best available evidence.
    Some proposals for creating a new comparative effectiveness 
research entity have pointed to the example of governments in other 
developed countries that use comparative and cost-effectiveness 
information. Experience with the use of comparative--and cost-
effectiveness evidence in these countries illustrates the way it can 
lead to patient access restrictions on important medical advances. In 
the United Kingdom and Australia, patients face very significant 
restrictions on access to treatments based on the use of rigid 
comparative- and cost-effectiveness standards to establish centralized 
coverage policies. Patients who have diseases such as cancer, 
Alzheimer's disease, diabetes, osteoporosis, blindness, and rare 
diseases, have faced government-imposed access restrictions. These 
access barriers illustrate one of the major challenges of centralized 
government approaches to generating and using comparative and cost-
effectiveness research, and the strengths of more pluralistic 
approaches.
    The range of different proposals for government comparative 
research illustrates some of the important, unresolved issues in this 
area. Important issues to be addressed include clarifying the 
definition and goals of comparative effectiveness research; defining 
the scope of government-supported comparative effectiveness research; 
establishing patient-centered approaches to research priority-setting 
and communication; developing research methods to support high quality 
comparative effectiveness research; and understanding the relationship 
between comparative effectiveness research, personalized medicine, and 
health information technology. *** TO PREVENT BAD BREAK AT 
BODONI DASH *** deg.
    PhRMA looks forward to working with policy makers to address these 
issues and advance the field of comparative effectiveness research.

                                 

           Statement of Society of General Internal Medicine
Mr. Chairman and Members of the Subcommittee:

    Thank you, Mr. Chairman, for calling this hearing to address the 
issues surrounding comparative clinical effectiveness for improving 
healthcare and thereby the health of Americans. Your long record of 
fighting for the best possible health care for the American people is 
well-known and deeply appreciated by all of us who share your passion 
for improving a system that everyone in America knows has great 
strengths and very deep flaws.
    We are testifying today on behalf of the Society of General 
Internal Medicine (SGIM), an organization comprised of approximately 
3,000 academic general internists throughout the United States. SGIM 
exists to promote improved patient care, research, and education in 
primary care and general internal medicine. Our members are specialists 
in adult medicine, treating patients who often present with complex, 
multiple diseases--some chronic, some acute--in a healthcare system 
that sometimes works against the provision of the highest quality care.
    As an organization, we are especially sensitive to the needs of 
minority and underserved populations, who suffer the most from 
inadequate access to quality care and the needless health consequences 
resulting from leaving otherwise minor conditions untreated.
    We understand that comparative clinical effectiveness research will 
not cure all the ills of the health care system. However, we believe 
that such the development of the methods, individuals, and capacity to 
do such research and to translate its findings into practice will very 
significantly contribute to improving the quality of health care in 
this country. Moreover, the implementation of the results of such 
research could ultimately result in reductions in the costs of care, 
thereby allowing much needed improvements in access to care for 
underserved Americans.
    As you know, Mr. Chairman, the FY08 Budget Resolution includes a 
provision authorizing the committees of jurisdiction in the House and 
Senate to establish a deficit neutral trust fund for comparative 
effectiveness research (CER) in healthcare. Because members of SGIM are 
leaders in the fields of clinical and health services research that 
form the basis for CER, because SGIM members are the leaders of the 
AHRQ and NIH research training programs that will need to produce those 
who will make such a national CER initiative possible, and because SGIM 
members are on the front line of delivering primary care, we fully 
expect they will play a major role in the development of this emerging 
sphere of research and its translation into clinical practice.
    As the Subcommittee prepares to address this critical issue, SGIM 
would like to offer comments on a variety of aspects of the legislation 
you are developing, including (a) the location of the research 
infrastructure within the existing governmental health care structure, 
(b) the methods to assure that the research priorities chosen as well 
as the conduct and dissemination of the research that is undertaken are 
held to the highest scientific standards, free of political or other 
undue influence, (c) the sources of funding for this initiative, and 
(d) the substantive areas that need to be addressed to maximize the 
impact of this research.
No Need to Reinvent the Wheel

    SGIM believes that the prioritization and governance of the conduct 
of comparative clinical effectiveness research is fundamentally a 
Federal Governmental responsibility. The federal responsibility for 
assuring that the provision of healthcare throughout the United States 
is of the highest quality should be unquestioned. No outside entity--
whether for profit or non-profit--can demonstrate the strength, the 
independence, the commitment to all citizens' health, and the degree of 
acceptance that the Federal Government can. To ``outsource'' such a 
responsibility would call into question the seriousness of the 
commitment and could create a series of undermining unintended 
consequences.
    Within the Federal Government, SGIM believes strongly that the 
Agency for Healthcare Research and Quality (AHRQ) is the natural home 
for any newly-developed CER program. Placing the program into an 
existing governmental agency saves both time and money during the 
initial--and crucial--implementation phase. CER is an important 
component of translational research. AHRQ's role in the Department of 
Health and Human Services (HHS) is facilitating the translation of 
medical evidence into practice, which it accomplishes, in part, through 
its Evidence-Based Practice Centers, as well as through collaborations 
with the Food and Drug Administration (FDA) and the Centers for 
Medicare and Medicaid Services (CMS). AHRQ's role in leading the 
development and implementation of health information technology (HIT) 
to support the translation of such efforts into improved access and to 
further quality improvement and patient safety also would leverage its 
being the home for CER. Understandably and importantly, the national 
healthcare industry outside of HHS looks to AHRQ as the fair and 
committed leader and partner to fulfilling this translational role.
    In addition, because AHRQ's authorizing statute already contains 
the mandate to address issues related to health disparities, locating 
the CER program in that Agency assures these critical issues will be 
addressed in any approved research and that they will be reported in 
the peer-reviewed scientific journal articles that result from that 
research.
Assuring an Objective and Independent Process

    Ultimately, comparative clinical effectiveness is about the 
provision of quality health care. But, we would be naive not to 
acknowledge that there are financial implications for the government, 
for private industry, for physicians, and for patients involved in 
nearly every decision that would be made in this field. For this 
reason, it is imperative that this research be undertaken under the 
most transparent, ethical and objective conditions possible.
    First, the decision about what research to do--and not do--must be 
based on scientific standards that are widely recognized and accepted. 
Priority setting by AHRQ must be a public process in which all 
stakeholders--individuals and organizations--have the opportunity to 
make their case for what they believe to be the appropriate priorities. 
But the decisions on those priorities should be made by an objective 
advisory committee of career experts from within the government and 
nationally-recognized authorities outside the government with no 
conflicts of interest that could raise questions concerning the 
objectivity of the decisions made.
    Second, the conduct of the research must be held to the highest 
ethical standards. SGIM believes that this research is best conducted 
at academic health centers and other similar institutions throughout 
the United States. Specific grant awards should be chosen by well-
established practices by peer-review panels operating within the 
confines of the priority-setting described above. Research and 
researchers should be reviewed periodically by career AHRQ employees to 
assure the adherence to the high ethical standards.
    Finally, it is critically important that the results of this 
objective research be made available and broadly disseminated to the 
American people and to the health care community in a timely and 
accurate manner. Therefore, concrete provisions should be included in 
the legislation to assure that no future Congressional Committee, no 
Executive Branch employee, and no Administration is able to delay or 
prevent the publication or dissemination of the results of this 
research.
Sources of Funding

    As the Subcommittee delves into this initiative, it will be 
obligated to consider the source from which the resources to make it a 
reality will come. This question is, to an extent, a subset of the 
issue described above, as the sources of funding used can have a 
significant impact on the objectivity and independence of the project.
    There is no question that Medicare Trust Fund money should and will 
be an important contributor to this effort. Medicare (and for that 
matter, Medicaid) stand to benefit greatly from the improvements in 
clinical effectiveness that will result from this concentrated research 
effort and it is reasonable that these funds will contribute to the 
investment needed to launch this initiative.
    However, it is also undeniable that the private health insurance 
industry will also benefit from learning what medical procedures, 
processes, and products have the highest clinical utility for patients. 
Clearly, treating or curing people faster results in long-term cost 
savings that will inure to the benefit of the insurance industry. It 
follows that they should be active participants in making the 
investments that lead to the needed research.
    The Subcommittee is uniquely positioned to devise a formula that 
will result in both the public sector and the private sector 
contributing to this initiative. It is important, however, that any 
formula used is broad-based and does not tie dollars invested to any 
specific research. To do otherwise would generate questions related to 
the independence of the research effort, specifically as it relates to 
the funding. That would undercut the arms-length relationship that will 
be crucial for establishing the program's integrity.
The Needs for a Successful Comparative Clinical Effectiveness Research 
        Initiative

    Merely suggesting that there should be a stronger national effort 
in comparative clinical research, that it should be handled according 
to the highest scientific standards through AHRQ, and that it should be 
funded broadly will not lead to a successful, high impact, and 
sustained result. For the success of this potentially transforming 
healthcare initiative, it is critical that the Subcommittee be specific 
in identifying those issues that are currently not being addressed 
through existing research mechanisms.
    To do this, SGIM recommends that the subcommittee create a six-part 
research program by statute to address the specific unmet needs of 
comparative clinical effectiveness research as called for in the Budget 
Resolution:
    1. Capacity to Develop Reports Based on Current Knowledge
          There is an almost unlimited amount of recent research, 
        funded by the National Institutes of Health (NIH), Centers for 
        Disease Control and Prevention (CDC), AHRQ, and others, that 
        has already been done that can provide the raw material to set 
        in motion quickly research that will add significantly to our 
        knowledge base of the comparative effectiveness of clinical 
        treatments.

          SGIM recommends that AHRQ use the infrastructure established 
        by Section 1013 of the Medicare Modernization Act (MMA), but 
        utilize not less than $25 million in the first year (with 
        amounts growing each year after that) to expand the existing 
        capacity beyond the current limited research that has been 
        conducted as a result of the modest effort of the MMA. Such 
        expansion would provide the wide range of data needed to 
        leverage optimally current information to result in a 
        measurable improvement in care.

          The goal of this effort would be the production of a minimum 
        of 80-100 reports yearly on a range of important healthcare 
        issues with decision support for implementation.
    2. Capacity to Develop New Understanding of Effective Care Based on
        Ongoing Care
          While SGIM believes it is important to obtain the maximum 
        benefit from existing research, we also believe in developing 
        new understanding about effectiveness based on on-going care. 
        Specifically, we would use, in part, the existing 
        infrastructure of the Centers for Education and Research on 
        Therapeutics (CERTs) and the Developing Evidence to Inform 
        Decisions about Effectiveness (DeCIDE) Network for this 
        purpose.
          At the same time, we recommend the creation of additional 
        capacity to develop new information on the effectiveness of 
        treatments through the use of existing and developing public 
        and private sector electronic medical records (EMR) systems. 
        This would not create new databases, but would leave control of 
        health records and data with the owners of the data--a 
        distributive model. With greater emphasis being placed on EMRs, 
        it is important that any CER program be positioned to capture 
        data on EMRs for maximum benefit.
          The objective of this effort would be to create methods and 
        capacity to do research cheaper and faster (e.g., 6-18 month 
        projects instead of multi-year multi-million dollar research) 
        that takes advantage of the increased use of EMRs and HIT for 
        assessing the outcomes of new and existing interventions for 
        which full scale clinical trials are not necessary. It is 
        anticipated that not less than $50 million could be expended on 
        this effort in the first year, with the available funds growing 
        each year thereafter.
    3. Accelerating the Translation of New Information into Practice 
        and
        Routine Healthcare Delivery
          As indicated above, SGIM does not believe it is necessary or 
        wise to reinvent the wheel in the implementation of this 
        effort. We believe it is possible to use the existing 
        infrastructure of networks including Accelerating Change and 
        Transformation in Organizations and Networks (ACTION), the 
        Primary Care Practice-based Research Networks (PBRNs), and 
        AHRQ's Innovations Clearinghouse. These networks would be ideal 
        for translating new information into practice and routine 
        healthcare delivery, something that currently is lacking in our 
        health care system.
          The goal of this aspect of the program would be to expand the 
        number of AHRQ's ``learning collaboratives'' that link cutting 
        edge providers and health plans with those seeking to emulate 
        the national leaders in adoption of health information 
        technology, patient safety, and quality improvement. In 
        addition, it should be a stated objective of the legislation to 
        create specific implementation roadmaps for proven 
        interventions and to expand support for training and 
        implementation teams. Not less than $50 million should be set 
        aside in the first year to meet these important objectives, 
        with the amount growing each year thereafter.
    4. Demonstrate Approaches that Improve Efficiency and Reduce Waste
          Currently, AHRQ provides very limited support for 
        organizational redesign to improve efficiency by 
        comprehensively addressing the structure and management of 
        healthcare settings, as well as processes of care. SGIM 
        recommends that this initiative be increased to not less than 
        $40 million in initial year funding, with the available funding 
        levels growing in each subsequent year.
          The goal of this program is to use demonstrated and proven 
        approaches for increasing the efficiency with which care is 
        organized and delivered rather than the obtrusive traditional 
        cost containment measures that often generate negative 
        unintended consequences. We expect that this will generate 
        patient and provider support for needed expansion of healthcare 
        coverage in the context of limited resources.
          In addition, we expect that this will create support for such 
        models of improved efficiency being adopted by healthcare 
        systems, clinics, and academic health centers that otherwise 
        would be hesitant to risk redesign of their systems.
    5. Increase Transparency on Value to Support Consumer Choice
          AHRQ presently plays a number of key roles related to quality 
        and value, including serving as the chair of the Ambulatory 
        Quality Alliance (AQA) and the co-chair of the joint AQA-
        Hospital Quality Alliance Steering Committee, a leading role 
        with the Quality Demonstration projects, and chair of the 
        Quality Interagency Coordination (QuIC) Task Force of all 
        Federal Departments and agencies with an interest in healthcare 
        quality. In addition, it operates many public-private 
        partnerships. Thus, it would be reasonable and practical for 
        AHRQ to undertake the development of systems specifically 
        designed to measure and report on healthcare performance. We 
        would anticipate a need for not less than $30 million in the 
        first year of this undertaking, with the funding growing 
        substantially in subsequent years.

          The first goal is for AHRQ to establish valid and robust 
        methods to measure and report the quality of healthcare 
        performance and to support transparency, accountability, and 
        rewards that are fair and accurate, something that is currently 
        very much in question and undermining trust in, and ultimately, 
        the positive impact of, such efforts.
          The second goal is to create sufficient capacity to assist in 
        the implementation of such methods, including the use of 
        voluntary, consensus-based standard-setting intended to 
        harmonize measures across Federal agencies and across the 
        entire healthcare industry.
    6. Research and Research Training to Support Remaking Healthcare
          SGIM believes that AHRQ can reasonably use not less than $75 
        million in the first year (with growing outyear funding) to 
        apply existing approaches to funding peer-reviewed, 
        investigator initiated research, research training, and career 
        development to expand greatly the ability to address the wide 
        and crucial needs for basic research in healthcare delivery, 
        the development of new methods, and demonstrations of 
        innovative approaches to improve healthcare, to train badly 
        needed new researchers in this area, and to establish, support 
        and retain early researchers' career development.
          The very specific goal of this initiative is to establish the 
        capacity for new innovative research and a cadre of researchers 
        nationally that would be positioned to apply the innovations 
        developed by biomedical researchers to improve the efficiency 
        and effectiveness of healthcare delivery and, ultimately, to 
        improve the health of our citizens with maximal efficiency.
          SGIM estimates that the total first year funding for the six 
        initiatives discussed above should not be less than $270 
        million. We also believe that the goal should be to grow this 
        funding to not less than $1.0 billion per year at the earliest 
        possible date. We would support the Subcommittee devising a 
        mechanism to assure that the funds available are not 
        artificially limited through binding statutory provisions that 
        prevent fully addressing the need. Given that 17 percent of the 
        Gross Domestic Product (GDP) is spent on health care, this is 
        an exceedingly modest proposal designed to elevate comparative 
        clinical effectiveness research closer to its appropriate level 
        within a well managed health care system.
Conclusion

    This Congress has an enormous task, and an enormous opportunity, 
before it in addressing the shortcomings of the healthcare system. 
Forty-seven million Americans, including nine million children, are 
struggling without health insurance. Hospitals and physicians are 
subject to annual reduction proposals in Medicare reimbursement rates. 
States are feeling the strain of a Medicaid system that often treats 
the poorest people in the most expensive manner possible--in emergency 
departments.
    In the face of these seemingly intractable problems, comparative 
clinical effectiveness is a research field whose time clearly has come. 
It will not solve everything that is wrong with the healthcare system. 
But, it is a strong, serious, positive step that this Congress and 
Administration can take together to improve the quality and the 
availability of healthcare for all Americans.
    The Society for General Internal Medicine is a long-time advocate 
for the funding of such research and training for such research, with 
the ultimate objective of improving healthcare and health. Our mission 
is to promote improved patient care, research, and education in primary 
care--a mission that is core to every action and position we take. We 
are pleased and proud to participate in the debate over this important 
initiative and look forward to working closely with you, Mr. Chairman, 
and the other Members of the Subcommittee in the days and months ahead 
to help bring this proposal to fruition.

    Thank you.

                                 
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