Extending Medicare Coverage for Preventive and Other Services

Marilyn J.Field, Robert L.Lawrence, and Lee Zwanziger, Editors

Committee on Medicare Coverage Extensions

Division of Health Care Services

INSTITUTE OF MEDICINE

NATIONAL ACADEMY PRESS
Washington, D.C.



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Extending Medicare Coverage for Preventive and Other Services Extending Medicare Coverage for Preventive and Other Services Marilyn J.Field, Robert L.Lawrence, and Lee Zwanziger, Editors Committee on Medicare Coverage Extensions Division of Health Care Services INSTITUTE OF MEDICINE NATIONAL ACADEMY PRESS Washington, D.C.

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Extending Medicare Coverage for Preventive and Other Services 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 competences and with regard for appropriate balance. Support for this project was provided by the Department of Health and Human Services (Contract Number 500–98–0275). The views presented are those of the Institute of Medicine Committee and are not necessarily those of the funding organization. International Standard Book Number 0-309-06889-4 Extending Medicare Coverage for Preventive and Other Services is 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. 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 Coverage for Preventive and Other Services 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 Coverage for Preventive and Other Services COMMITTEE ON MEDICARE COVERAGE EXTENSIONS ROBERT S.LAWRENCE, M.D. (Chair), Associate Dean for Professional Education and Programs and Professor of Health Policy, Johns Hopkins University School of Hygiene and Public Health, Baltimore JACK C.EBELER, Senior Vice President and Director, Robert Wood Johnson Foundation, Princeton, N.J. MARTHE R.GOLD, M.D., Arthur C.Logan Professor and Chair, Department of Community Medicine, City University of New York Medical School BERTRAM L.KASISKE, M.D., Director, Division of Nephrology, Hennepin County Medical Center and Professor of Medicine, University of Minnesota LAUREN L.PATTON, D.D.S., Associate Professor of Dental Ecology, University of North Carolina School of Dentistry, Chapel Hill (from May 1999)* STEPHEN G.PAUKER, M.D., Vice Chairman for Clinical Affairs, Department of Medicine, New England Medical Center, and Sara Murray Jordan Professor of Medicine, Tufts University School of Medicine ROBERT S.STERN, M.D., Professor of Dermatology, Harvard University Medical School at Beth Israel Deaconess Medical Center, Boston Staff MARILYN J.FIELD, Ph.D., Study Director and Deputy Director, Health Care Services LEE L.ZWANZIGER, Ph.D., Senior Program Officer DEE SUTTON, Administrative Assistant *   Dr. Patton replaced Robert J.Genco, D.D.S., Ph.D., distinguished professor and chairman, Department of Oral Biology, and distinguished professor of microbiology, Schools of Dentistry and Medicine, State University of New York (SUNY) at Buffalo, who was unable to continue his service on the committee.

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Extending Medicare Coverage for Preventive and Other Services Acknowledgments In developing this report, the committee benefited from the expertise and experience of many individuals. In particular, it learned much from the presenters and participants in three workshops held in May and June 1999. Appendix A lists the workshop participants, presenters, and agendas. The authors of the commissioned background papers presented in Appendixes B (Mark Helfand, Karen Eden, and Susan Mahon), C (Alex White, James Lipton, William Kohn, and Lauren Patton), D (Robert Gaston), and E (Jesse Kerns, Al Dobson, and Joan Da Vanzo) made essential contributions to this report through their evidence reviews and their extensive discussions with committee members and staff. Their ability to develop the evidence reviews on a tight schedule for discussion at the workshops was especially appreciated. At the Health Care Financing Administration, project officer Katharine Pirotte and medical adviser Joseph Chin were always helpful. Paul Eggers provided information and guidance for developing estimates of the cost of extending Medicare coverage of immunosuppressive drugs. Others at the agency who provided information and explanations about policies and practices included John Whyte, Peter Hickman, Joan Stieber, Odette Cohen, Willam Larson, Dorothy Honemann, and Lauren Geyer. The committee and staff likewise appreciate the assistance of David Atkins at the Agency for Health Care Policy and Research in developing a cooperative strategy for a background paper on skin cancer screening that could be used both by the committee and by the U.S. Preventive Services Task Force (consistent with provisions of the legislation providing for this study). The Task Force will be publishing clinical practice recommendations on skin cancer screening and other topics early in 2000.

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Extending Medicare Coverage for Preventive and Other Services The committee and staff also benefited from information provided by a number of other individuals and organizations including Greg Raab of the Health Industry Manufacturers Association, Andrew Swire of the Pharmaceutical Research and Manufacturers of America, Dolph Chianchiano and Troy Zimmerman of the National Kidney Foundation, Julia Christensen of the Congressional Budget Office, Charles (Bud) Conklin of Carilion Dental Care, Alan Geller of Boston University, Ira Parker of the University of California at San Diego, Geoffrey Cook of Novartis, Bill Leinhos of Fero Pharmaceuticals, Robert Spieldenner of the United Network for Organ Sharing, John Rutkauskas of the American Academy of Pediatric Dentistry (formerly of the Federation of Special Care Organizations in Dentistry), and Cheryl Jacobs, Marilyn Leister, and Melissa Kamps, all of Fairview University Transplant Services. At the Institute of Medicine, study staff appreciate the assistance of Claudia Carl, Mike Edington, Sue Barren, Sally Stanfield, Ellen Johnson, Barbara Rice, Janice Mehler, Kay Harris, and Linda Kilroy among others. Florence Poillon helped in copy editing the report. 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: James D.Bader, D.M.D., School of Dentistry, University of North Carolina at Chapel Hill David R.Challoner, M.D., Institute for Science and Health Policy, University of Florida Chester W.Douglass, D.D.S., Department of Oral Health Policy and Epidemiology, Harvard University School of Dental Medicine Robert J.Genco, Ph.D., D.D.S., Department of Oral Biology, School of Dental Medicine, University at Buffalo, State University of New York Bernard J.Gersh, M.B., Ch.B., D. Phil., Mayo Clinic, Cardiovascular Diseases Division, Rochester, Minnesota Barbara A.Gilchrest, M.D., Department of Dermatology, Boston University Thomas A.Gonwa, M.D., Dallas Nephrology Associates, Dallas, Texas Roland E. (Guy) King, Ernst & Young, Annapolis, Maryland

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Extending Medicare Coverage for Preventive and Other Services Peter B.Lockhart, D.D.S., Department of Oral Medicine, Carolinas Medical Center, Charlotte, North Carolina Lorelei Mucci, M.P.H., Department of Oral Health Policy and Epidemiology, Harvard School of Dental Medicine Joseph P.Newhouse, Ph.D., Department of Health Policy and Management, Harvard University, Cambridge Len Nichols, Ph.D., Health Policy Center, The Urban Institute, Washington, D.C. Arthur J.Sober, M.D., Department of Dermatology, Massachusetts General Hospital, Boston George E.Thibault, M.D., Partners HealthCare System, Inc., Boston 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 Coverage for Preventive and Other Services Preface When Congress created the Medicare program over three decades ago, no one could anticipate the dramatic improvements in diagnostic and therapeutic measures that would emerge in subsequent years. Nor was there any expectation that health care costs would so steadily outpace the annual increase in the cost of living and cause the Medicare budget to grow so rapidly. Pressures to expand the original coverage limitations have become a regular feature of debates about the Medicare budget. The original concept of providing health insurance for those age 65 or over to protect them from the substantial costs of medical care, especially that requiring hospitalization for unexpected illnesses, was first changed to include coverage of some younger individuals with disabilities or permanent kidney failure. In 1980, the first preventive service was added when pneumococcal vaccine was covered. Our committee was asked to analyze the possible extension of Medicare coverage for three very different conditions: skin cancer screening, medically necessary dental services, and elimination of time limits on coverage of immunosuppressive drugs for certain transplant recipients. The committee commissioned background papers for review of the evidence published in peer-reviewed scientific papers, heard from interested specialty organizations and patient advocacy groups, and contracted with consultants for estimates of the cost to Medicare of various coverage scenarios. In the course of our work we were struck by the advances in the methods for reporting clinical research, reviewing scientific evidence, and assessing the effectiveness of health care services. At the same time, we saw that continued work was needed to improve these methods and to employ them consistently to guide decisions and recommendations about clinical care and coverage policy. We include in this

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Extending Medicare Coverage for Preventive and Other Services report our observations of these systemic problems with coverage decision making and offer some examples of different approaches for the Congress to consider. Robert S.Lawrence, M.D. Chair

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Extending Medicare Coverage for Preventive and Other Services Contents     SUMMARY   1 1   INTRODUCTION   13      The Medicare Program,   15      Medicare Coverage Decisions,   18      Coverage, Access to Care, and Outcomes,   22      Overview of the Report,   24 2   OBJECTIVES, PRINCIPLES, AND METHODS   26      Objectives and Principles,   26      Analytic Strategy,   29      Estimating Costs to Medicare of Extending Coverage,   33 3   SCREENING FOR SKIN CANCER   38      Assessment Approach: Intervention, Population, and Outcomes,   40      Population Burden of Disease,   43      Availability of Effective Treatment,   45      Screening and Diagnostic Procedures,   46      Benefits and Harms of Skin Cancer Screening,   50      Evidence of Benefits from Early Detection of Skin Cancer Through Screening,   51      Estimated Costs to Medicare of Extending Coverage,   53      Statements of Others About Skin Cancer Screening,   57      Committee Findings and Conclusions,   58

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Extending Medicare Coverage for Preventive and Other Services 4   MEDICALLY NECESSARY DENTAL SERVICES   63      Defining Medically Necessary Dental Services,   65      Assessment Approach: Intervention, Population, and Outcomes,   66      Head and Neck Cancer,   69      Leukemia and Lymphoma,   75      Solid Organ Transplants,   80      Heart Valve Repair or Replacement,   83      Estimated Costs to Medicare of Extending Coverage,   85      Statements of Others on “Medically Necessary Dental Services,”   89      Committee Findings and Conclusions,   91 5   IMMUNOSUPPRESSIVE DRUGS FOR TRANSPLANT PATIENTS   99      Evolution of Immunosuppressive Drug Coverage by Medicare,   100      Assessment Approach,   102      Burden of Disease,   104      Availability of Effective Treatment,   109      Barriers to Adequate Therapy,   111      Estimated Costs to Medicare of Extending Coverage,   118      Statements of Others on Coverage for Immunosuppressants,   123      Committee Findings and Conclusions,   124 6   FUTURE DIRECTIONS   127      Linking Evidence to Medicare Coverage: The Case of Preventive Services,   127      Strengthening the Infrastructure for Coverage Decisions,   131      The Limits of Coverage,   136      The Limits of Evidence,   138     REFERENCES   141     APPENDIXES     A   Study Activities,   165 B   Screening for Skin Cancer,   172 C   Medically Necessary Dental Services,   222 D   Part 1: Immunosuppressive Therapy: The Scientific Basis and Clinical Practice of Immunosuppressive Therapy in the Management of Transplant Recipients,   286     Part 2. Transplantation and Immunosuppressive Medications: Evolution of Medicare Policy Involving Transplantation and Immunosuppressive Medications—Past Developments and Future Directions,   310

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Extending Medicare Coverage for Preventive and Other Services E   Cost Estimates for Expanded Medicare Benefits: Skin Cancer Screening, Medically Necessary Dental Services, and Immunosuppressive Therapy for Transplant Recipients,   329 F   Committee Biographies,   363     INDEX   367 BOXES, FIGURES, AND TABLES Boxes 3.1   Summary of Estimated Costs to Medicare for Covering a New Program of Screening Asymptomatic Beneficiaries for Skin Cancer,   54 4.1   Summary of Estimated Costs to Medicare for “Medically Necessary Dental Care” Associated with Certain Medical Conditions,   86 5.1   Summary of Estimated Costs to Medicare for Extending Coverage of Immunosuppressive Drugs After Transplant Operations,   119 Figures 2.1   Evidence pyramid for assessing a health care intervention,   28 2.2   Evidence pyramid for assessing a coverage policy,   29 3.1   Evidence pyramid for assessing a screening intervention,   42 3.2   causal pathway: Skin cancer screening, with examples of uncertainty that could affect outcome at several key points,   59 4.1   Evidence pyramid for assessing “medically necessary dental services,”   69 5.1   Evidence pyramids for extending coverage of immunosuppressive drugs,   104 5.2   Possible consequences when a Medicare-eligible kidney transplant patient reaches the end of coverage and cannot locate other funds for immunosuppressive drugs,   116 Tables 2.1   Expanding Coverage to a New Intervention: Possible Outcomes and Directions for Decisionmakers,   36 4.1   Medicare Coverage of Dental Services as Specified in Statute or by the Health Care Financing Administration,   64 4.2   Summary of Dental Services Currently Covered and Not Covered Under Medicare for Selected Diseases or Conditions,   68 5.1   Summary of Current Medicare Coverage Policy on Transplants,   103

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Extending Medicare Coverage for Preventive and Other Services 5.2   Number and Types of Transplants Performed in 1998,   105 5.3   Number of Patients on Waiting Lists at Year’s End, Selected Years,   108 5.4   Graft and Patient Survival Rates at One and Five Years,   109 5.5   Medicare Expenditure per ESRD Patient, 1994,   122 6.1   Preventive Services Covered by Medicare,   128 6.2   Interventions Considered and Recommended by USPSTF for Periodic Health Examinations for Persons Age 65 and Older,   130

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