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 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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Extending Medicare Reimbursement in Clinical Trials 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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Extending Medicare Reimbursement in Clinical Trials 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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Extending Medicare Reimbursement in Clinical Trials 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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Extending Medicare Reimbursement in Clinical Trials 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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