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Extending Medicare Reimbursement in Clinical Trials
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.
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Extending Medicare Reimbursement in Clinical Trials
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.
International Standard Book Number 0-309-06888-6
Additional copies of this report are available for sale from the
National Academy Press,
2101 Constitution Avenue, N.W., Box 285, Washington, DC 20055. Call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area), or visit the NAP on-line bookstore at www.nap.edu. The full text of this report is available on line at www.nap.edu/readingroom.
For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu.
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.
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Extending Medicare Reimbursement in Clinical Trials
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.
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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.
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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.
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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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Contents
EXECUTIVE SUMMARY
1
1
CLINICAL TRIALS IN THE UNITED STATES
15
Background on Clinical Trials,
15
Sponsorship of Clinical Trials,
22
Clinical Trial Protocol Review and Monitoring,
24
Costs of Patient Care in Clinical Trials,
25
Clinical Trials Registry,
27
2
PAYING FOR PATIENT CARE IN CLINICAL TRIALS
30
Current Medicare Reimbursement Rules Relating to Investigational Medical Services and Clinical Trials,
31
The Status Quo in Reimbursement,
37
Programs and Proposals for Reimbursing Patient Care Costs in Clinical Trials,
44
Appendix: A Primer on Medicare,
48
3
RECOMMENDATIONS FOR MEDICARE CLINICAL TRIAL REIMBURSEMENT
53
Recommendations,
55
Administrative and Cost Implications,
63
Conclusion,
64
REFERENCES
65
APPENDIXES
A
Glossary, Acronyms, and Abbreviations,
67
B
Committee Biographies,
73
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