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CANCER-RELATED GENETIC TESTING AND COUNSELING

Workshop Proceedings

National Cancer Policy Forum

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu



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National Cancer Policy Forum

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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. This study was supported by Contracts No. HHSN261200611002C, 200-2005-13434, TO #1, HHSM-500-2005-00179P, HHSP23320042509XI, TO #4, 223-01-2460, TO #27, HHSH25056133, TO #6 between the National Academy of Sciences and, respec- tively, the National Cancer Institute, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Food and Drug Administration, and the Health Resources and Ser- vices Administration. Support was also received from the American Cancer Society, the American Society of Clinical Oncology, and C-Change. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-10977-0 International Standard Book Number-10: 0-309-10977-3 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 2007 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: Institute of Medicine (IOM). 2007. Cancer-related genetic testing and counseling: Workshop proceedings. Washington, DC: The National Academies Press.

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“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe Advising the Nation. Improving Health.

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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 man- date that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone 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. Charles M. Vest 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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NATIONAL CANCER POLICY FORUM HAROLD L. MOSES (Chair), Professor of Cancer Biology, Medicine, and Pathology, Director Emeritus, Vanderbilt-Ingram Comprehensive Cancer Center, Vanderbilt University Medical Center PETER BACH, Associate Member, Memorial Sloan-Kettering Cancer Center EDWARD BENZ, President, Dana-Farber Cancer Institute THOMAS BURISH, Past Chair, ACS Board and Provost, Notre Dame University BETTY FERRELL, Research Scientist, City of Hope National Medical Center JOSEPH FRAUMENI, Director, Division of Cancer Epidemiology and Genetics, National Cancer Institute STEPHEN FRIEND, Executive Vice President, Oncology, Merck PATRICIA GANZ, ASCO Board Member and Professor of Medicine, University of California at Los Angeles ROY HERBST, Chief, Section of Thoracic Medical Oncology, M.D. Anderson Cancer Center THOMAS KEAN, Executive Director, C-Change WILLIAM LAWRENCE, Director, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality LYNN MATRISIAN, Chair, Division of Cancer Biology, Vanderbilt University JOHN NIEDERHUBER, Director, National Cancer Institute DAVID PARKINSON, Senior Vice President, Oncology Research and Development, Biogen IDEC EDITH PEREZ, Director, Cancer Clinical Study Unit, Mayo Clinic SCOTT RAMSEY, Member, Fred Hutchinson Cancer Research Center EDDIE REED, Director, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention MARGARET SPITZ, Chair of Epidemiology, M.D. Anderson Cancer Center ELLEN STOVALL, President and CEO, National Coalition for Cancer Survivorship BARRY STRAUBE, Director, Office of Clinical Standards and Quality and Chief Medical Officer, CMS JANET WOODCOCK, Deputy Commissioner and Chief Medical Officer, Food and Drug Administration 

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Staff SHARYL NASS, Senior Program Officer ROGER HERDMAN, Director, National Cancer Policy Forum LAURA LEVIT, Research Associate MARY ANN PRYOR, Senior Program Assistant This volume has been reviewed in draft form in accordance with procedures approved by the NRC’s Report Review Committee. We wish to thank Betty Ferrell, Ph.D., FAAN, for her review and Clyde Behney for serving as coordinator of the review. i

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Contents Abbreviations and Acronyms ix 1 Introduction 1 2 Prepared Presentations and Discussion 3 References 117 Appendix: Workshop Agenda 121 ii

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Abbreviations and Acronyms AAFP American Academy of Family Practitioners ACMG American College of Medical Genetics ACS American Cancer Society AHRQ Agency for Healthcare Research and Quality AMA American Medical Association ASCO American Society of Clinical Oncology ASHG American Society of Human Genetics ASR analyte-specific reagent CDC Centers for Disease Control and Prevention CLIA Clinical Laboratory Improvement Amendments of 1988, or CLIA CME continuing medical education CMS Centers for Medicare and Medicaid Services CPT current procedural terminology DHHS Department of Health and Human Services DOE Department of Energy DTC direct-to-consumer ELSI ethical, legal, and social implications FAP familial adenomatous polyposis ix

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x ABBREVIATIONS AND ACRONYMS FDA Food and Drug Administration FTC Federal Trade Commission FTE full-time equivalent GAO Government Accountability Office GI gastrointestinal GINA Genetic Information Nondiscrimination Act GNRH gonadotrophin-releasing hormone GRE Graduate Record Examination HIPAA Health Insurance Portability and Accountability Act HMO health maintenance organization HNPCC hereditary nonpolyposis colorectal cancer HRSA Health Resources and Services Administration IOM Institute of Medicine IRB institutional review board IVDMIA in vitro diagnostic multivariate index assay MRI magnetic resonance imaging NCCN National Comprehensive Cancer Network NCI National Cancer Institute NIH National Institutes of Health NPI national provider identification NSABP B-04 National Surgical Adjuvant Breast and Bowel Project NSGC National Society of Genetic Counselors OCN oncology-certified nurse PSA prostate specific antigen RBRVS resource-based relative value system RVU relative value unit UPIN universal provider identification number USC University of Southern California USPSTF U.S. Preventive Services Task Force