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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×

Implementing and
Evaluating Genomic
Screening Programs
in Health Care Systems

PROCEEDINGS OF A WORKSHOP

Siobhan Addie, Meredith Hackmann, Theresa Wizemann, and
Sarah Beachy, Rapporteurs

Roundtable on Genomics and Precision Health

Board on Health Sciences Policy

Health and Medicine Division

images

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Washington, DC
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This project was supported by contracts between the National Academy of Sciences and 23andMe (unnumbered contract); Accenture (unnumbered contract); Air Force Medical Service (FA8052-17-P-0007); American Academy of Nursing (unnumbered contract); American College of Medical Genetics and Genomics (unnumbered contract); American Medical Association (unnumbered contract); American Society of Human Genetics (unnumbered contract); Association for Molecular Pathology (unnumbered contract); Biogen (unnumbered contract); Blue Cross and Blue Shield Association (unnumbered contract); College of American Pathologists (unnumbered contract); Color Genomics (unnumbered contract); Department of Veterans Affairs (Contract No. VA240-14-C-0037); Eisai Inc. (unnumbered contract); Eli Lilly and Company (unnumbered contract); Health Resources and Services Administration (HHSH250201500001I, Order No. HHSH250); Illumina, Inc. (unnumbered contract); Johnson & Johnson (unnumbered contract); Marc Grodman (unnumbered contract); Merck & Co., Inc. (Contract No. CMO-170216-001875); National Institutes of Health (Contract No. HHSN263201200074I; Task Order No. HHSN 26300093): National Cancer Institute; National Human Genome Research Institute; National Institute of Mental Health; National Institute of Nursing Research; National Institute on Aging; and Office of Disease Prevention; National Society of Genetic Counselors (unnumbered contract); and Northrop Grumman Health IT (unnumbered contract). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-47341-5
International Standard Book Number-10: 0-309-47341-1
Digital Object Identifier: https://doi.org/10.17226/25048

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Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and evaluating genomic screening programs in health care systems: Proceedings of a workshop. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25048.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×

PLANNING COMMITTEE ON IMPLEMENTING AND EVALUATING GENOMIC SCREENING PROGRAMS IN HEALTH CARE SYSTEMS1

W. GREGORY FEERO (Co-Chair), Representative of the Journal of the American Medical Association; Faculty, Maine Dartmouth Family Medicine Residency Program, Fairfield, ME

DAVID VEENSTRA (Co-Chair), Professor, Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle

NAZNEEN AZIZ, Executive Director, Kaiser Permanente Research Bank, Kaiser Permanente, Oakland, CA

GAIL GELLER, Director of Education, Berman Institute of Bioethics, Johns Hopkins University, Baltimore, MD

JEFFREY HANKOFF, Medical Officer, Cigna Healthcare, Glendale, CA

GEORGE J. ISHAM, Senior Advisor, HealthPartners; Senior Fellow, HealthPartners Institute for Education and Research, HealthPartners, Minneapolis, MN

MUIN KHOURY, Director, National Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, GA

BRUCE KORF, Wayne H. and Sarah Crews Finley Chair in Medical Genetics; Director, Department of Genetics, Heflin Center for Genomic Sciences, University of Alabama, Birmingham

CHRISTINE LU, Associate Professor, Department of Population Medicine; Co-Director, Precision Medicine Translational Research Center (PROMoTeR), Harvard Pilgrim Health Care Institute, Harvard Medical School, Boston, MA

MARCELLA NUNEZ-SMITH, Associate Professor, General Internal Medicine; Director, Equity Research and Innovation Center; Director, Center for Research Engagement; Core Faculty, National Clinician Scholars Program; Deputy Director, Yale Center for Clinical Investigation, Yale School of Medicine, New Haven, CT

JAMES O’LEARY, Chief Innovation Officer, Genetic Alliance, Washington, DC

CATHY WICKLUND, Past President, National Society of Genetic Counselors; Director, Graduate Program in Genetic Counseling; Associate Professor, Department of Obstetrics and Gynecology, Northwestern University, Evanston, IL

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×

Roundtable on Genomics and Precision Health Staff

SARAH H. BEACHY, Director

SIOBHAN ADDIE, Program Officer

MEREDITH HACKMANN, Research Associate

REBECCA RAY, Senior Program Assistant

Board on Health Sciences Policy Staff

ANDREW M. POPE, Director

STEPHANIE YOUNG, Program Coordinator (from January 2018)

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×

ROUNDTABLE ON GENOMICS AND PRECISION HEALTH1

GEOFFREY GINSBURG (Co-Chair), Director, Center for Applied Genomics and Precision Medicine, Duke University, Durham, NC

SHARON TERRY (Co-Chair), President and Chief Executive Officer, Genetic Alliance, Washington, DC

NAOMI ARONSON, Executive Director, Technology Evaluation Center, Blue Cross and Blue Shield Association, Chicago, IL

NAZNEEN AZIZ, Executive Director, Kaiser Permanente Research Bank, Kaiser Permanente, Oakland, CA

KARINA BIENFAIT, Head, Global Genomics Policy, Process and Compliance, Merck and Co., Inc., Kenilworth, NJ (from January, 2018)

REBECCA BLANCHARD, Executive Director, Genetics and Pharmacogenomics, Head of Clinical Pharmacogenomics, Merck and Co., Inc., West Point, PA (until January 2018)

RUTH BRENNER, Chief of Air Force Medical Support Personalized Medicine, Air Force Medical Support Agency, Falls Church, VA

ANN CASHION, Scientific Director, National Institute of Nursing Research, National Institutes of Health, Bethesda, MD

ROBERT B. DARNELL, President and Scientific Director, New York Genome Center; Investigator, Howard Hughes Medical Institute, Heilbrunn Cancer Professor and Senior Physician, Head, Laboratory of Molecular Neuro-Oncology, The Rockefeller University, New York, NY

BARRY DICKINSON, Director, Science and Biotechnology, American Medical Association, Chicago, IL (until February 2018)

JOSEPH DONAHUE, Managing Director, Global Life Sciences Research and Development, Accenture, Berwyn, PA

MICHAEL J. DOUGHERTY, Director of Education, American Society of Human Genetics, Bethesda, MD (until August 2017)

W. GREGORY FEERO, Representative of the Journal of the American Medical Association; Faculty, Maine Dartmouth Family Medicine Residency Program, Fairfield, ME

ANDREW N. FREEDMAN, Branch Chief, Clinical and Translational Epidemiology Branch, Epidemiology and Genetics Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, MD (until February 2018)

MARC GRODMAN, Assistant Professor of Clinical Medicine, Columbia University, New York, NY

___________________

1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×

JILL M. HAGENKORD, Chief Medical Officer, Color Genomics, Mountain View, CA

EMILY HARRIS, Deputy Associate Director, Epidemiology and Genomics Research Program, National Cancer Institute, Rockville, MD (from February 2018)

RICHARD J. HODES, Director, National Institute on Aging, Bethesda, MD

MUIN KHOURY, Director, National Office of Public Health Genomics, Centers for Disease Control and Prevention, Atlanta, GA

THOMAS LEHNER, Director, Office of Genomics Research Coordination, National Institute of Mental Health, Bethesda, MD

DEBRA LEONARD, Representative of the College of American Pathologists; Professor and Chair of Pathology and Laboratory Medicine, College of Medicine, University of Vermont, Burlington, VT

DAVID LITWACK, Staff Fellow, U.S. Food and Drug Administration, Silver Spring, MD

SEAN C. McCONNELL, Senior Policy Analyst, American Medical Association, Chicago, IL (from February 2018)

ROBERT McCORMACK, Head, Biomarker Translation, Disease Interceptor Accelerator, Janssen Research & Development, Raritan, NJ

MONA MILLER, Executive Director, American Society of Human Genetics, Bethesda, MD (from January 2018)

JENNIFER MOSER, Health Science Specialist, Genomic Medicine Program, Office of Research and Development, Department of Veterans Affairs, Washington, DC

LAURA K. NISENBAUM, Advisor, Chorus Clinical Development, Eli Lilly and Company, Indianapolis, IN (until November 2017)

MICHELLE PENNY, Director, Computational Biology and Genomics, Biogen, Boston, MA

VICTORIA M. PRATT, Representative, Association for Molecular Pathology; Associate Professor, Clinical Medical and Molecular Genetics, and Director, Pharmacogenomics Diagnostic Laboratory, Department of Medical and Molecular Genetics, School of Medicine, Indiana University, Indianapolis

MARY V. RELLING, Member and Chair, Department of Pharmaceutical Sciences, St. Jude Children’s Research Hospital, Memphis, TN (until September 2017)

LAURA LYMAN RODRIGUEZ, Senior Advisor to the Director for Research Policy, National Human Genome Research Institute, National Institutes of Health, Bethesda, MD (from July 2017)

NADEEM SARWAR, President, Andover Product Creation Innovation System, Eisai Inc., Cambridge, MA

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×

DEREK SCHOLES, Director of Science Policy, American Society of Human Genetics, Bethesda, MD (until December 2017)

SHERI SCHULLY, Senior Advisor for Disease Prevention, Office of Disease Prevention, National Institutes of Health, Bethesda, MD

JOAN A. SCOTT, Chief, Genetic Services Branch, Division of Services for Children with Special Health Needs, Maternal and Child Health Bureau, Rockville, MD

SAM SHEKAR, Chief Medical Officer, Health Information Technology Program, Northrop Grumman Information Systems, McLean, VA

KATHERINE JOHANSEN TABER, Director, Personalized Medicine, American Medical Association, Chicago, IL (until November 2017)

RYAN TAFT, Senior Director, Population and Medical Genomics, Illumina, Inc., San Diego, CA (from April 2017)

JOYCE TUNG, Vice President, Research, 23andMe, Mountain View, CA (from April 2017)

DAVID VEENSTRA, Professor, Pharmaceutical Outcomes Research and Policy Program, Department of Pharmacy, University of Washington, Seattle

MICHAEL S. WATSON, Executive Director, American College of Medical Genetics and Genomics, Bethesda, MD

CATHERINE A. WICKLUND, Past President, National Society of Genetic Counselors; Director, Graduate Program in Genetic Counseling; Associate Professor, Department of Obstetrics and Gynecology, Northwestern University, Evanston, IL

ROBERT WILDIN, Chief, Genomic Healthcare Branch, National Human Genome Research Institute, Bethesda, MD (until July 2017)

HUNTINGTON F. WILLARD, Professor and Director, Precision Health, Geisinger Health System, Rockville, MD (from February 2018)

JANET K. WILLIAMS, Representative, American Academy of Nursing; Professor of Nursing, Chair of Behavioral and Social Science, College of Nursing, University of Iowa, Iowa City

Roundtable on Genomics and Precision Health Staff

SARAH H. BEACHY, Director

SIOBHAN ADDIE, Program Officer

MEREDITH HACKMANN, Research Associate

REBECCA RAY, Senior Program Assistant

Board on Health Sciences Policy Staff

ANDREW M. POPE, Director

STEPHANIE YOUNG, Program Coordinator (from January 2018)

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×

Reviewers

This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.

We thank the following individuals for their review of this proceedings:

GILLIAN HOOKER, Concert Genetics

GEORGE MENSAH, National Heart, Lung, and Blood Institute (National Institutes of Health)

DEAN REGIER, University of British Columbia

ROBERT WILDIN, University of Vermont Health Network

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by MELVIN WORTH. He was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
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Acknowledgments

The support of the Roundtable on Genomics and Precision Health was crucial to the planning and conduct of the workshop on Implementing and Evaluating Genomic Screening Programs in Health Care Systems. Federal sponsors are the Air Force Medical Service; Department of Veterans Affairs; Health Resources and Services Administration; National Cancer Institute; National Human Genome Research Institute; National Institute of Mental Health; National Institute of Nursing Research; National Institute on Aging; and National Institutes of Health Office of Disease Prevention. Nonfederal sponsorship was provided by 23andMe; Accenture; American Academy of Nursing; American College of Medical Genetics and Genomics; American Medical Association; American Society of Human Genetics; Association for Molecular Pathology; Biogen; Blue Cross and Blue Shield Association; College of American Pathologists; Color Genomics; Eisai Inc.; Eli Lilly and Company; Illumina, Inc.; Johnson & Johnson; Marc Grodman; Merck & Co., Inc.; National Society of Genetic Counselors; and Northrop Grumman Health IT.

The Roundtable on Genomics and Precision Health wishes to express gratitude to the members of the planning committee for their work in developing an excellent workshop agenda and the expert speakers who explored how progress could be made in integrating genomics into large-scale health organizations. The project director would like to thank the project staff, who worked diligently to develop both the workshop and the resulting proceedings.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×

Acronyms and Abbreviations

ACA

Patient Protection and Affordable Care Act

ACO

accountable care organization

ACMG

American College of Medical Genetics and Genomics

AML

acute myeloid leukemia

CDC

Centers for Disease Control and Prevention

CFIR

Consolidated Framework for Implementation Research

CMS

Centers for Medicare & Medicaid Services

COAG

Clarification of Optimal Anticoagulation

CPIC

Clinical Pharmacogenetics Implementation Consortium

CRCP

colorectal cancer and polyposis

CSER

Clinical Sequencing Evidence-Generating Research

EGAPP

Evaluation of Genomics Applications in Practice and Prevention

EHR

electronic health record

eMERGE

Electronic Medical Records and Genomics Network

FH

familial hypercholesterolemia

FQHC

federally qualified health center

GINA

Genetic Information Nondiscrimination Act of 2008

GUARDD

Genetic Testing to Understand and Address Renal Disease Disparities

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
×
HBOC

hereditary breast and ovarian cancer

HIE

health information exchange

ICER

incremental cost-effectiveness ratio

IHC

immunohistochemistry

IGNITE

Implementing Genomics in Practice

LDL

low-density lipoprotein

MSI

microsatellite instability

NHGRI

National Human Genome Research Institute

NIH

National Institutes of Health

OMOP

Observational Medical Outcomes Partnership

PACS

picture archiving and communication system

PCORI

Patient-Centered Outcomes Research Institute

PCORnet

National Patient-Centered Clinical Research Network

QALY

quality-adjusted life year

SNP

single nucleotide polymorphism

UAB

University of Alabama at Birmingham

U-PGx

Ubiquitous Pharmacogenomics

UVM

University of Vermont

VA

Department of Veterans Affairs

VHA

Veterans Health Administration

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2018. Implementing and Evaluating Genomic Screening Programs in Health Care Systems: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25048.
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Genomic applications are being integrated into a broad range of clinical and research activities at health care systems across the United States. This trend can be attributed to a variety of factors, including the declining cost of genome sequencing and the potential for improving health outcomes and cutting the costs of care. The goals of these genomics-based programs may be to identify individuals with clinically actionable variants as a way of preventing disease, providing diagnoses for patients with rare diseases, and advancing research on genetic contributions to health and disease. Of particular interest are genomics- based screening programs, which will, in this publication, be clinical screening programs that examine genes or variants in unselected populations in order to identify individuals who are at an increased risk for a particular health concern (e.g., diseases, adverse drug outcomes) and who might benefit from clinical interventions.

On November 1, 2017, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop to explore the challenges and opportunities associated with integrating genomics-based screening programs into health care systems. This workshop was developed as a way to explore the challenges and opportunities associated with integrating genomics-based programs in health care systems in the areas of evidence collection, sustainability, data sharing, infrastructure, and equity of access. This publication summarizes the presentations and discussions from the workshop.

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