CR report - public comment draft

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• Publié par: Shewyer
• Nombre de lectures: 76
• Langue: English

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DRAFT
This draft report does not represent the final findings, conclusions or recommendations of SACGHS nor does it represent the views of the U.S. Government.







Coverage and Reimbursement of
Genetic Tests and Services
_________________________________

Draft Report of the
Secretary’s Advisory Committee on Genetics, Health, and Society







PUBLIC COMMENT DRAFT
April 2005

Coverage and Reimbursement of Genetic Tests and Services 1
DRAFT
This draft report does not represent the final findings, conclusions or recommendations of SACGHS
nor does it represent the views of the U.S. Government.








































Disclaimer: Current Procedural Terminology (CPT) is copyright 2005 American Medical Association. All
Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The
AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to
government use.
Coverage and Reimbursement of Genetic Tests and Services 2
DRAFT
This draft report does not represent the final findings, conclusions or recommendations of SACGHS
nor does it represent the views of the U.S. Government.

About SACGHS

The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) was
established in 2002 by the Secretary of Health and Human Services (HHS) as a public
forum for deliberations on the broad range of human health and societal issues raised by
the development and use of genetic tests and, as warranted, to provide advice on these
issues. The scope of the Committee’s charge includes:
• Assessing how genetic tests are being integrated into health care and public
health;
• Studying the clinical, ethical, legal and societal implications of new medical
applications, such as preimplantation genetic diagnosis, and emerging
technological approaches to clinical testing;
• Identifying opportunities and gaps in research and data collection efforts;
• Exploring the use of genetics in bioterrorism;
• Examining current patent policy and licensing practices for their impact on access
to genetic tests;
• Analyzing uses of genetic information in education, employment, insurance,
including health, disability, long-term care, and life, and law, including family,
immigration, and forensics; and
• Serving as a public forum for discussion of emerging scientific, ethical, legal and
social issues raised by genetic tests.

SACGHS is composed of 13 experts in a wide range of disciplines relevant to genetic
technologies, including molecular biology, human genetics, health care, public health,
bioterrorism, ethics, forensics, law, psychology, social sciences, education, occupational
health, insurance, consumer issues, and other relevant fields.

The Committee also includes 19 nonvoting ex officio members from the Administration
for Children and Families (HHS), Agency for Healthcare Research and Quality (HHS),
Centers for Disease Control and Prevention (HHS), Centers for Medicare & Medicaid
Services (HHS), Food and Drug Administration (HHS), Health Resources and Services
Administration (HHS), National Institutes of Health (HHS), Office for Civil Rights (HHS),
Office for Human Research Protections (HHS), Office of the Secretary (HHS), Department
of Commerce, Department of Defense, Department of Education, Department of Energy,
Department of Justice, Department of Labor, Department of Veterans Affairs, Equal
Employment Opportunity Commission, and Federal Trade Commission.
Coverage and Reimbursement of Genetic Tests and Services 3
DRAFT
This draft report does not represent the final findings, conclusions or recommendations of SACGHS
nor does it represent the views of the U.S. Government.

COMMITTEE ROSTER
_________________________________________________________________________________________________________

Chair

Joan Y. Reede, M.D., M.P.H., M.S. Department of Health and Human Reed V. Tuckson, M.D.
Assistant Professor of Maternal & Services Senior Vice President
Child Health Consumer Health & Medical Care
Harvard School of Public Health Martin Dannenfelser Advancement
Assistant Professor of Medicine Administration for Children and UnitedHealth Group
Harvard Medical School Families Minnetonka, MN
Director, Minority Faculty
Development Program Francis D. Chesley, Jr., M.D. Members
Boston, MA Agency for Healthcare
Research and Quality
Cynthia E. Berry, J.D. Joseph Telfair, Dr.P.H., M.S.W.-
Partner M.P.H. Muin J. Khoury, M.D., Ph.D.
Powell Goldstein Frazer & Murphy
Associate Professor Centers for Disease Control Washington, DC
Department of Maternal & Child and Prevention
Health
Barbara Willis Harrison, M.S. University of Alabama at Sean Tunis, M.D., M.Sc.
Certified Genetic Counselor & Birmingham School of Public Centers for Medicare &
Instructor
Health Medicaid Services Division of Medical Genetics
Birmingham, AL Department of Pediatrics
Steven I Gutman, M.D., M.B.A.
Howard University College of Huntington F. Willard, Ph.D. Food and Drug Administration
Medicine Director
Washington, DC
Institute of Genome Sciences & Sam Shekar, M.D., M.P.H.
Policy Health Resources and Services C. Christopher Hook, M.D.
Vice Chancellor for Genome Administration
Director of Ethics Education Sciences
Mayo Graduate School of Genome Sciences Research Francis S. Collins, M.D., Ph.D.
Medicine
Duke University Medical Center National Institutes of Health Assistant Professor of Medicine
Durham, NC Mayo Medical School
Robinsue Frohboese, J.D.,
Rochester, MN Emily S. Winn-Deen, Ph.D. Ph.D.
Vice President Office for Civil Rights
Debra G.B. Leonard, M.D., Ph.D.
Strategic Planning & Business Vice-Chair of Laboratory Medicine
Development Michael A. Carome, M.D. New York Presbyterian Hospital
Cepheid Office for Human Research
New York, NY Sunnyvale, CA Protections

Agnes Masny, R.N., M.P.H., M.S.N.
Kimberly S. Zellmer, J.D. Howard Zucker, M.D. Adjunct Assistant Professor of
Mission Hills, KS Office of Public Health and Nursing
Science
Temple University College of
Allied Health Professionals Vahid Majidi, Ph.D. Ex Officios Research Assistant & Nurse
Department of Justice Practitioner
Hratch G. Semerjian, Ph.D. Family Risk Assessment Program
Thomas Alexander, J.D. Department of Commerce Fox Chase Cancer Center Department of Labor Philadelphia, PA Col. Martha Turner, USAF, Ph.D.
Ellen Fox, M.D. Department of Defense Edward R.B. McCabe, M.D., Ph.D.
Department of Veteran Affairs Professor & Executive Chair
Doug Mesecar Department of Pediatrics Cari M. Dominguez Department of Education David Geffen School of Medicine Equal Employment Opportunity Physician-in-Chief
Commission Daniel Drell, Ph.D. Mattel Children's Hospital
Department of Energy University of California-Los
Matthew Daynard, J.D. Angeles Federal Trade Commission
Los Angeles, CA

Coverage and Reimbursement of Genetic Tests and Services 4
DRAFT
This draft report does not represent the final findings, conclusions or recommendations of SACGHS
nor does it represent the views of the U.S. Government.

Table of Contents

Preface ……………………………………………………………………….......7

Introduction ……………………………………………………………………..9

Genetic Tests & Services: Challenges to the
U.S. Health Care System …………………………………………….………13

Coverage …………..……..19

Coverage Decisions …....…………………………..……………………………….19

Medicare Coverage ………………………………………………………………….28

Medicaid Coverage ……….…………………………………………………………33

Billing and Reimbursement ………………………………….……………..35

Coding Systems ……………………………………………………………………..35

Medicare Clinical Laboratory Fee Schedule ………………………..…………..43

Billing and Reimbursement of Genetic Tests…..……………………………….45
Reimbursement of Genetic Counseling Services………………..48

Broader Issues ………………………………….…………………………….53

Health Disparities ……………………………………………….……………………….53

Provider Education and Training ………………….………………………………….54

Coverage and Reimbursement of Genetic Tests and Services 5
DRAFT
This draft report does not represent the final findings, conclusions or recommendations of SACGHS
nor does it represent the views of the U.S. Government.

Public Awareness………………………………………………………………………..54

Appendix A: Health Care Financing in the U.S.………….………………57

Appendix B: Report of the Work Group on Genetic Counseling
Services ………………………………………………………………………...69

Appendix C: Public Commenters ………………………………………….93
Coverage and Reimbursement of Genetic Tests and Services 6
DRAFT
This draft report does not represent the final findings, conclu