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Suggested Citation:"Front Matter." Institute of Medicine. 2000. Extending Medicare Reimbursement in Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/9742.
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Extending Medicare Reimbursement in Clinical Trials

Committee on Routine Patient Care Costs in Clinical Trials for Medicare Beneficiaries

Henry J. Aaron and Hellen Gelband, Editors

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.

Suggested Citation:"Front Matter." Institute of Medicine. 2000. Extending Medicare Reimbursement in Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/9742.
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NATIONAL ACADEMY PRESS
2101 Constitution Avenue, N.W. Washington, DC 20418

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard for appropriate balance.

Support for this project was provided by the Health Care Financing Administration (Contract No. 500-98-0275). The views presented in this report are those of the Institute of Medicine Committee on Routine Patient Care Costs in Clinical Trials for Medicare Beneficiaries and are not necessarily those of the funding agencies.

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Copyright 2000 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

Suggested Citation:"Front Matter." Institute of Medicine. 2000. Extending Medicare Reimbursement in Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/9742.
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THE NATIONAL ACADEMIES

National Academy of Sciences

National Academy of Engineering

Institute of Medicine

National Research Council

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. William A. Wulf is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy's purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

Suggested Citation:"Front Matter." Institute of Medicine. 2000. Extending Medicare Reimbursement in Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/9742.
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Suggested Citation:"Front Matter." Institute of Medicine. 2000. Extending Medicare Reimbursement in Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/9742.
×

COMMITTEE ON ROUTINE PATIENT CARE COSTS IN CLINICAL TRIALS FOR MEDICARE BENEFICIARIES

HENRY J. AARON, Ph.D. (Chair),

The Brookings Institution, Washington, D.C.

ROBERT M. CALIFF, M.D.,

Duke University Medical Center

KAY DICKERSIN, Ph.D.,

Brown University School of Medicine

BERTIE A. FORD, M.S, R.N., O.C.N.,

Amgen, inc., Columbus, Ohio

PETER D. FOX, Ph.D.,

PDF Inc., Chevy Chase, Md.

LANCE LIEBMAN, L.L.B.,

Columbia Law School

JOHN M. LUDDEN, M.D.,

Harvard Medical School

ROBERT S. McDONOUGH, M.D., J.D.,

Aetna U.S. Health care, Hartford, Conn.

WILLIAM T. McGIVNEY, Ph.D.,

National Comprehensive Cancer Network, Rockledge, Pa.

ROSEMARY ROSSO, J.D.,

Baltimore/Washington Breast Cancer Advocacy Group, National Breast Cancer Coalition, Washington, D.C.

ELIZABETH STONER, M.D.,

Merck & Co., Inc., Rahway, N.J.

ROBERT THOMPSON, M.S., M.A.,

Medtronic, Minneapolis, Minn.

PETER J. WHITEHOUSE, M.D., Ph.D.,

Case Western Reserve University School of Medicine

Study Staff

HELLEN GELBAND, Study Director

ELLEN JOHNSON, Administrative Assistant

ANNIKA OLSSON, Research Assistant

ROBERT M. COOK-DEEGAN, Director,

National Cancer Policy Board

Consultants

ALLEN DOBSON, The Lewin Group, Fairfax, Va.

ERON STURM, The Lewin Group, Fairfax, Va.

Suggested Citation:"Front Matter." Institute of Medicine. 2000. Extending Medicare Reimbursement in Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/9742.
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REVIEWERS

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council's Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the Institute of Medicine in making the published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The committee wishes to thank the following individuals for their participation in the review of this report:

WADE AUBRY, M.D., The Lewin Group and University of California at San Francisco

TOM AULT, Health Policy Alternatives, Washington, D.C.

PATRICIA A. BARR, J.D., Barr, Sternberg, and Moss, Bennington, Vt.

NORMAN DANIELS, Ph.D., Newton, Mass.

OLGA JONASSON, M.D., F.A.C.S., The American College of Surgeons, Chicago

ALAN S. LICHTER, M.D., University of Michigan Medical School

JAN PLATNER, J.D., JRI Health/Justice Resource Institute, Boston

HELEN L. SMITS, M.D., Ivoryton, Conn.

ROBERT YOUNG, M.D., Fox Chase Cancer Center, Philadelphia

Although the individuals listed above have provided constructive comments and suggestions, it must be emphasized that responsibility for the final content of this report rests entirely with the authors and the Institute of Medicine.

Suggested Citation:"Front Matter." Institute of Medicine. 2000. Extending Medicare Reimbursement in Clinical Trials. Washington, DC: The National Academies Press. doi: 10.17226/9742.
×

Acknowledgments

We thank the following people for providing information or other assistance during the course of this project.

Wade Aubry

University of California at San Francisco

Grant P. Bagley

Health Care Financing Administration

Carmella Bocchino

American Association of Health Plans

Charles A. Coltman, Jr.

San Antonio Cancer Institute

Chuck Cutler

Prudential Health Care

Ronald Herberman

Association of American Cancer Institutes

Doug Kamerow

Agency for Health Care Policy and Research

Deborah Kamin

American Society of Clinical Oncology

Allen S. Lichter

University of Michigan School of Medicine

Joanne R. Less

Food and Drug Administration

Sridhar Mani

Montefiore Medical Center, Albert Einstein College of Medicine

Mary McCabe

National Cancer Institute

Alexa McCray

National Library of Medicine

Charles J. McDonald

American Cancer Society

Stephen J. Northrup

Medical Device Manufacturers Association

Michael O'Conneil

Mayo Clinic Cancer Center

Arnold Potosky

National Cancer Institute

Richard Rettig

Rand Corporation

Richard L. Schilsky

University of Chicago Cancer Research Center

Ellen M. Smith

General Accounting Office

Fran Visco

National Breast Cancer Coalition

Judith L. Wagner

Congressional Budget Office

Robert C. Young

Fox Chase Cancer Center

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Increasingly over the past five years, uncertainty about reimbursement for routine patient care has been suspected as contributing to problems enrolling people in clinical trials. Clinical trial investigators cannot guarantee that Medicare will pay for the care required, and they must disclose this uncertainty to potential participants during the informed consent process. Since Medicare does not routinely "preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial.

This report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.

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