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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 

SANDER M. LEVIN, Michigan 

JIM MCDERMOTT, Washington 

JOHN LEWIS, Georgia 

RICHARD E. NEAL, Massachusetts 

MICHAEL R. MCNULTY, New York 

JOHN S. TANNER, Tennessee 

XAVIER BECERRA, California 

LLOYD DOGGETT, Texas 

EARL POMEROY, North Dakota 

STEPHANIE TUBBS JONES, Ohio 

MIKE THOMPSON, California 

JOHN B. LARSON, Connecticut 

RAHM EMANUEL, Illinois 

EARL BLUMENAUER, Oregon 

RON KIND, Wisconsin 

BILL PASCRELL, JR., New Jersey 

SHELLEY BERKLEY, Nevada 

JOSEPH CROWLEY, New York 

CHRIS VAN HOLLEN, Maryland 

KENDRICK MEEK, Florida 

ALLYSON Y. SCHWARTZ, Pennsylvania 

ARTUR DAVIS, Alabama 

JIM MCCRERY, Louisiana 

WALLY HERGER, California 

DAVE CAMP, Michigan 

JIM RAMSTAD, Minnesota 

SAM JOHNSON, Texas 

PHIL ENGLISH, Pennsylvania 

JERRY WELLER, Illinois 

KENNY HULSHOF, Missouri 

RON LEWIS, Kentucky 

KEVIN BRADY, Texas 

THOMAS M. REYNOLDS, New York 

PAUL RYAN, Wisconsin 

ERIC CANTOR, Virginia 

JOHN LINDER, Georgia 

DEVIN NUNES, California 

PAT TIBERI, Ohio 

JON PORTER, Nevada 

JANICE MAYS, Chief Counsel and Staff Director 

BRETT LOPER, Minority Staff Director 

SUBCOMMITTEE ON HEALTH 

FORTNEY PETE STARK, California, Chairman 

LLOYD DOGGETT, Texas 

MIKE THOMPSON, California 

RAHM EMANUEL, Illinois 

XAVIER BECERRA, California 

EARL POMEROY, North Dakota 

STEPHANIE TUBBS JONES, Ohio 

RON KIND, Wisconsin 

DAVE CAMP, Michigan 

SAM JOHNSON, Texas 

JIM RAMSTAD, Minnesota 

PHIL ENGLISH, Pennsylvania 

KENNY HULSHOF, Missouri 

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. 

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iii 

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 

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(1) 

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:] 

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ADVISORY 

FROM THE COMMITTEE ON WAYS AND MEANS 

SUBCOMMITTEE ON HEALTH 

FOR IMMEDIATE RELEASE CONTACT: (202) 225–3943 

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. 

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DETAILS FOR SUBMISSION OF WRITTEN COMMENTS: 

Please Note: Any person(s) and/or organization(s) wishing to submit for the hearing record must follow the appropriate link on the hearing page of the Committee 

website and complete the informational forms. From the Committee homepage, 

http://waysandmeans.house.gov, select ‘‘110th Congress’’ from the menu entitled, ‘‘Committee Hearings’’ (http://waysandmeans.house.gov/Hearings.asp?congress=18). 

Select the hearing for which you would like to submit, and click on the link entitled, 

‘‘Click here to provide a submission for the record.’’ Once you have followed the online instructions, completing all informational forms and clicking ‘‘submit’’ on the 

final page, an email will be sent to the address which you supply confirming your 

interest in providing a submission for the record. You MUST REPLY to the email 

and ATTACH your submission as a Word or WordPerfect document, in compliance 

with the formatting requirements listed below, by close of business June 26, 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 House Office Buildings. For questions, or if you encounter technical problems, please call (202) 225–1721. 

FORMATTING REQUIREMENTS: 

The Committee relies on electronic submissions for printing the official hearing 

record. As always, submissions will be included in the record according to the discretion of the Committee. The Committee will not alter the content of your submission, 

but we reserve the right to format it according to our guidelines. Any submission 

provided to the Committee by a witness, any supplementary materials submitted for 

the printed record, and any written comments in response to a request for written 

comments must conform to the guidelines listed below. Any submission or supplementary item not in compliance with these guidelines will not be printed, but will 

be maintained in the Committee files for review and use by the Committee. 

1. All submissions and supplementary materials must be provided in Word or WordPerfect 

format and MUST NOT exceed a total of 10 pages, including attachments. Witnesses and submitters are advised that the Committee relies on electronic submissions for printing the official 

hearing record. 

2. Copies of whole documents submitted as exhibit material will not be accepted for printing. 

Instead, exhibit material should be referenced and quoted or paraphrased. All exhibit material 

not meeting these specifications will be maintained in the Committee files for review and use 

by the Committee. 

3. All submissions must include a list of all clients, persons, and/or organizations on whose 

behalf the witness appears. A supplemental sheet must accompany each submission listing the 

name, company, address, and telephone and fax numbers of each witness. 

Note: All Committee advisories and news releases are available on the World 

Wide Web at http://waysandmeans.house.gov. 

The Committee seeks to make its facilities accessible to persons with disabilities. 

If you are in need of special accommodations, please call 202–225–1721 or 202–226– 

3411 TTD/TTY in advance of the event (four business days notice is requested). 

Questions with regard to special accommodation needs in general (including availability of Committee materials in alternative formats) may be directed to the Committee as noted above. 

f 

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 

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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 prosmartinez on PROD1PC64 with HEARING

5 

viders 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 

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6 

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. 

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7 

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 

smartinez on PROD1PC64 with HEARING

8 

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. 

smartinez on PROD1PC64 with HEARING

9 

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. 

f 

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 

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10 

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. 

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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. 

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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 

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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? 

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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? 

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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. 

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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, 

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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. 

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search 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-todate. 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 

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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. 

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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 

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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. 

f 

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 

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that rate of growth continued, you wind up on the top line. Medicare and Medicaid would grow from 41⁄2 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. 

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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 

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over, 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 

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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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f 

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-forprofit 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 

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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? 

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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 

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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? 

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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 

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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 

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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. 

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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 cresmartinez on PROD1PC64 with HEARING

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ate 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 resmartinez on PROD1PC64 with HEARING

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port 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. 

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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. 

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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, 

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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? 

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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 

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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 evidencebased 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 

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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 evidencebased 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. 

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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 cirsmartinez on PROD1PC64 with HEARING

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cumstances, 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, inhouse 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. 

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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 21⁄2% 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. 

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I am advocating for a Center for Comparative Clinical Effectiveness that would 

have a different focus and serve an information function rather than a decisionmaking 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 inhouse 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 

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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. 

f 

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. 

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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, 

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1Kaiser 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. 2 Anderson G, Hussey PS. Comparing Health System Performance in OECD Countries: CrossNational Comparisons Can Determine Whether Additional Health Care Spending Results in 

Better Outcomes. Health Affairs. May/June 2001;20(3):219–32. 3Fisher, 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. 

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

• the presence of significant quality gaps particularly when compared to other 

industrialized nations that spend much less on healthcare; 2

• the presence of significant variation in healthcare costs throughout this country without any evidence that increased costs result in improved care.3

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. 

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4Medical 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. 5Pearson D, and Rawlins, M. Quality, innovation and value of money. JAMA, Nov. 

2005;294(20):2618–2622. 

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

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. 

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. 

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6 Joint letter on SGR legislative options sent to key Congressional Committee staff delivered 

on May 17, 2007. 7Medical 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. 

• 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

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. 

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 treatsmartinez on PROD1PC64 with HEARING

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8O’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&FIRSTINDEX=0& 

resourcetype=HWCIT on May 7, 2007. 

ment. 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

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 

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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: 

Æ The establishment of mechanisms to facilitate the implementation of 

health information technology (HIT) throughout the system 

Æ The implementation of the Patient-Centered Medical Home (PCMH) 

care model. 

f 

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. 

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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, lowercost 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. 

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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. 

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. 

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 medsmartinez on PROD1PC64 with HEARING

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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. 3 Reports can be downloaded for free at www.CRBestBuyDrugs.org. 

4For 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. 

ical 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

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 healthcare 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. 

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-ofcharge to the public. This is important, since one of our key target audiences is lowincome consumers who use multiple drugs—the very people who are most in need 

of unbiased, accurate information. 

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 

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5 ‘‘Medicare Prescription Drug Benefit: Beneficiaries Can Lower Out-of-Pocket Costs While 

Getting Safe and Effective Drugs,’’ Consumers Union, March 2, 2006. 

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, informationsharing 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: 

Category of Drug 

Potential 

Individual 

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. 

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. 

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6They 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. 8The amount proposed, $3 billion over five years, represents about.24 percent of projected funding over five years of about $12.3 trillion. 9PLoS Medicine, May 2005, Vol. 2, Issue 5 e138, ‘‘Medical Journals are an Extension of the 

Marketing Arm of Pharmaceutical Companies,’’ by Richard Smith. 10Key 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. 

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

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. 

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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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. 

f 

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 

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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 

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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, retir- ees 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 

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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. 

f 

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 

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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. 

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main 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 

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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 evidencebased 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. 

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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 

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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 

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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 comorbidities, 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 

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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. 

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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. 

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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.] 

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[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 

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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: 

Æ Advances in the quality of care provided, including the appropriate use 

of preventive, screening and diagnostic services and reduction in medical/ 

medication errors; Æ 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 Æ 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 

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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 longterm 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 evidencebased medicine, we look forward to working on this effort to deliver the right treatment to the right patient at the right time. 

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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. 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. 

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. 

f 

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. 

• 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. 

• The National Institute of Mental Health (NIMH) found that, within a class 

of antipsychotic drugs, the older, less expensive drug (Perphenazine) was just 

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iiiLieberman, 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. 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. vWoolley, 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). viPlacement, Coordination, and Funding of Health Services Research within the Federal Gov- ernment, AcademyHealth (Sept. 2005). Available on the Web at http://www.chsr.org/ 

placementreport.pdf. 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. 

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. 

• In a study of more than 2,200 patients funded mostly by the Veterans’ 

Administration, researchers found that those who underwent nonemergency 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. 

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

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): 

• 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 

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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). ixFederal Funding for Health Services Research, Coalition for Health Services Research (Dec. 

2006). Available on the Web at http://www.chsr.org/AHfundingreport1206.pdf. 

by AHRQ and others for the purpose of making comparative effectiveness 

findings. 

• 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. 

In addition, we believe that increased investment in comparative effectiveness research must be coupled with greater investment in the research infrastructure—the 

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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 comparative effectiveness 

studies with oversight and guidance from an external board and 

panel of experts. 

• AHRQ would remain the lead agency for health 

services research, supporting a 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 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). 

• AHRQ would remain the lead agency for health 

services research, supporting a 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. 

• AHRQ would also establish an independent FFRDC 

with the limited mission of reviewing and synthesizing comparative effectiveness research. 

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Option 3: AHRQ remains as currently structured and a new separate quasi-government entity is established to fund and conduct 

comparative effectiveness research. 

• AHRQ would remain the lead agency for health 

services research, supporting a 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 quasi-governmental agency retaining most existing functions 

and adding comparative effectiveness research. 

• AHRQ reconstituted as a new quasi-governmental 

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 

field of health services research 

should continue to support a broad 

and comprehensive range of topics. 

• Recognizes that while comparative effectiveness research 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 

based on scientific evidence and 

kept separate from funding and 

coverage decisions. 

• Given the controversial nature of comparativeness 

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 conducting comparative effectiveness research should maintain 

close linkage to the lead agency 

for health services research. 

• Recognizes that comparative effectiveness research 

is a subset of the broader field of 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 conducting comparative effectiveness research should be subject to congressional oversight. 

• Since comparative effectiveness research 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. 

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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. iiiOlafsson E, Hauser WA, Gudmundsson G. Long-Term Survival of People with Unprovoked 

Seizures: A Population Based Study. Epilepsia. 1998;39:89–92. ivZielinski 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. viMotamedi G, Meador K. Epilepsy and cognition. Epilpesy Behav. 2003;4(Suppl. 2):25–38. viiFisher 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. viiiSillanpa ̈a ̈ 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. 

Principle 5: Entity commissioning 

or conducting comparative effectiveness research should involve 

key stakeholders to assure transparency of the methods and process, promote public acceptance of 

research findings, and support for 

the entity’s mission. 

• Given the controversial nature of comparative effectiveness research, this principle recognizes the importance of 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 

f 

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

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xiSander JW. The Use of Antiepileptic Drugs—Principles and Practice. Epilepsia. 

2004;45(Suppl. 6):28–34. xii EUCARE. European white paper on epilepsy: Pharmacological Treatment. Epilepsia 

2003;44(Suppl. 6):33–4. xiiiStokes 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. xivGlauser 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. xvFrench 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. xviFrench 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 

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. 

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

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 

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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 

f 

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 resmartinez on PROD1PC64 with HEARING

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flect 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, 

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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. 

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• 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: 

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Æ 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. Æ 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: 

Æ All medications are identical Æ None of the medications are efficacious in treating depression. Æ 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. Æ 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. 

f 

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 

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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 famismartinez on PROD1PC64 with HEARING

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1Statement by Dr. Claude Lenfant, Director National Heart, Blood and Lung Institute. Dateline NBC. 21 May 2001. 2 Agency for Health Care Quality and Research. Closing the Quality Gap: Diabetes Care Strategies. April 2004. 

lies 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. 

f 

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 quasigovernmental 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

• Physician organizations have pointed out that there are treatments known to 

effectively control diabetes, yet many patients do not receive them.2

• 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 presmartinez on PROD1PC64 with HEARING

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3D. Cutler, et al. The Value Of Antihypertensive Drugs: A Perspective On Medical Innovation Health Affairs, January/February 2007; 26(1): 97–110. 4Milt 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. 

mature deaths and 8333,000 hospitalizations for heart attack and stroke already avoided.3

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

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. 

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PhRMA looks forward to working with policy makers to address these issues and 

advance the field of comparative effectiveness research. 

f 

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. 

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partment of Health and Human Services (HHS) is facilitating the translation of 

medical evidence into practice, which it accomplishes, in part, through its EvidenceBased 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 naı ̈ve 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. 

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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 multimillion 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 

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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 publicprivate 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 

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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. 

Æ 

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