Medicare Coverage of Routine Screening for Thyroid Dysfunction

Marc B. Stone and Robert B. Wallace, Editors

Committee on Medicare Coverage of Routine Thyroid Screening

Board on Health Care Services

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C. www.nap.edu



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Medicare Coverage of Routine Screening for Thyroid Dysfunction Marc B. Stone and Robert B. Wallace, Editors Committee on Medicare Coverage of Routine Thyroid Screening Board on Health Care Services INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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 Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services (Contract Number 500-01-0055). The views presented in this report are those of the Institute of Medicine Committee on Medicare Coverage of Routine Thyroid Screening and are not necessarily those of the funding agencies. International Standard Book Number 0-309-08885-2 (Book) International Standard Book Number 0-309-50706-5 (PDF) Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2003 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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This page in the original is blank. “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Shaping the Future for Health

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THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine 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. Wm. 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. Harvey V. Fineberg 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. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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COMMITTEE ON MEDICARE COVERAGE OF ROUTINE THYROID SCREENING ROBERT B. WALLACE, M.D. (Chair), the Irene Ensminger Stecher Professor of Epidemiology and Internal Medicine, University of Iowa College of Medicine GAY J. CANARIS, M.D., M.S.P.H., Assistant Professor of Medicine in the Department of Internal Medicine, University of Nebraska Medical Center, College of Medicine INDER J. CHOPRA, M.D., Professor of Medicine, University of California at Los Angeles Center for Health Services LAURENCE MAURICE DEMERS, Ph.D., Distinguished Professor of Pathology and Medicine, Pennsylvania State University College of Medicine NEIL R. POWE, M.D., M.P.H., M.B.A., Professor of Medicine in the Department of Medicine, Johns Hopkins University School of Medicine JANE E. SISK, Ph.D., Professor of Health Policy, Mount Sinai School of Medicine ROBERT D. UTIGER, M.D., Clinical Professor of Medicine, Harvard University School of Medicine STEPHEN D. WALTER, Ph.D., Professor of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University STEVEN H. WOOLF, M.D., M.P.H., Professor of Family Practice and Preventive and Community Medicine, Virginia Commonwealth University Staff MARC B. STONE, M.D., Study Director and Senior Program Officer, Board on Health Care Services STELLA OPARA, Senior Program Assistant

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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 NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its 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. We wish to thank the following individuals for their review of this report: Alfred O. Berg, M.D., M.P.H., Professor and Chair, Department of Family Medicine, University of Washington School of Medicine Byron Wm. Brown, Jr., Ph.D., Professor of Biostatistics, Emeritus, Department of Health Research and Policy, Stanford University Gerard N. Burrow, M.D. Dean Emeritus, Yale University School of Medicine, David Cooper, M.D., Professor of Medicine Johns Hopkins University School of Medicine Danny O. Jacobs, M.D., M.P.H., Arnold K. Lempka Distinguished Professor of Surgery and Chairman, Department of Surgery, Creighton University Judith R. Lave, Ph.D. Professor of Health Economics, Department of Health Policy & Management, Graduate School of Public Health, University of Pittsburgh

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Adrian M. Ostfeld, M.D. Anna M.R. Lauder Professor of Epidemiology and Public Health and of Medicine, Emeritus, Yale University School of Medicine Frank A. Riddick Jr., M.D., Chief Executive Officer Emeritus, Ochsner Clinic Foundation Carole Spencer, Ph.D., F.A.C.B., Professor of Medicine, University of Southern California Judith L. Wagner, Ph.D. National Cancer Policy Board Noel S. Weiss, M.D., Dr.P.H., Professor, Department of Epidemiology, School of Public Health and Community Medicine, University of Washington Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Barbara J. McNeil, M.D., Ph.D., Ridley Watts Professor and Head Department of Health Care Policy, Harvard Medical School, and Joseph P. Newhouse, Ph.D., John D. MacArthur Professor of Health Policy and Management Harvard University. Appointed by the National Research Council and Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

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Preface When the Medicare program was established in 1965, it was viewed as a form of financial protection for the elderly against catastrophic medical expenses, primarily those related to hospitalization for unexpected illnesses. The first expansions to the program increased the eligible population from the retired to the disabled and to persons receiving chronic renal dialysis. It was not until 1980 that an expansion of services beyond those required “for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member”1 was included in Medicare. These services, known as preventive services, are intended either to prevent disease (by vaccination) or to detect disease (by diagnostic test) before the symptoms of illness appear. Our Committee was formed “to conduct a study on the addition of coverage of routine thyroid screening using a thyroid stimulating hormone test as a preventive benefit provided to Medicare beneficiaries under Title XVIII of the Social Security Act for some or all Medicare beneficiaries.”2 We approached this task in the context of another Institute of Medicine report published in 2000, Extend ing Medicare Coverage for Preventive and Other Services. In addressing this issue, we were aided by a background paper commissioned by the United States Preventive Services Task Force that reviewed the evidence published in peer-reviewed scientific papers, heard from a broad range of experts in relevant fields, 1   Title XVIII of the Social Security Act, Section 1862(a)(1)(A). 2   Consolidated Appropriations Act for 2001, Section 123.

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and looked at the current state of thyroid disease and testing among Medicare beneficiaries through both an analysis of Medicare claims data and a population-based study of Medicare beneficiaries. Robert B. Wallace, M.D. Chair

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Acknowledgments The Committee would like to express its appreciation for the fine assistance it received from a number of individuals: David Atkins and the United States Preventive Services Task Force, in response to the legislation ordering this volume, commissioned the Systematic Evidence Review that is the principal background paper for this document as well as part of the process for the Task Force’s new clinical practice recommendations for screening for thyroid disease. Mark Helfand developed the comprehensive Evidence Review (presented in Appendix B) and provided additional advice and insight. Robert Lindeman provided additional data and analysis pursuant to his work on the New Mexico Elder Health Survey. Mark Helfand, Robert Lindeman, Douglas Bauer, Chester Ridgway, Marshall McBean, and Mark Danese provided thoughtful presentations and discussion at the October workshop (Appendix A). Mary Gabay and Anthony D’Andrea of Peterson Consulting developed and executed the technical specifications and programming for the claims data analysis. Katharine Pirotte of the Centers for Medicare and Medicaid Services served as project officer for this volume and was helpful in all matters, particularly in securing access to Medicare claims data for analysis. At the Institute of Medicine, the staff would like to thank, among others, Clyde Behney, Janet Corrigan, Tony Burton, Teresa Redd, Bronwyn Schrecker, Jennifer Bitticks, Sue Barron, Linda Kilroy, Donald Holmes, and Bill McLeod.

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Contents     SUMMARY   1 1   INTRODUCTION   7     The Origins of Medicare,   8     Medicare and Health Insurance Today,   9     Medicare Coverage Policy and Preventive Services,   11     Methods and Approach,   12     References,   13 2   PATHOPHYSIOLOGY AND DIAGNOSIS OF THYROID DISEASE   14     Thyroid Function Testing,   16     Testing for Diagnosis and Management of Thyroid Dysfunction,   17     References,   20 3   PREVALENCE AND CONSEQUENCES OF THYROID DYSFUNCTION   21     Prevalence of Subclinical and Overt Hypothyroidism,   23     Consequences of Subclinical Hypothyroidism,   24     Prevalence of Subclinical and Overt Hyperthyroidism,   27     Consequences of Subclinical Hyperthyroidism,   27     Conclusion,   29     References,   30

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4   SCREENING FOR THYROID DYSFUNCTION   32     Principles of Disease Prevention,   32     Evidence of Efficacy of Screening for Thyroid Dysfunction,   36     Evidence of Efficacy of Treatment for Thyroid Dysfunction,   40     Summary and Conclusions,   42     References,   43 5   THE COST OF COVERAGE   44     Coverage and Use of Preventive Services,   44     Estimating Demand for TSH Screening,   47     Estimated Costs of Screening,   53     Conclusions,   66     References,   68 6   CONCLUSIONS AND RECOMMENDATIONS   69     APPENDIXES     A   Workshop on Screening for Thyroid Dysfunction   73 B   Screening for Thyroid Disease: Systematic Evidence Review   75 C   Diagnoses Currently Covered by Medicare for Serum TSH Testing   114 D   Committee Biographies   119