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Grant Details

Grant Number: 5R01CA221870-02 Interpret this number
Primary Investigator: Phillips, Kathryn
Organization: University Of California, San Francisco
Project Title: Coverage, Price, and Reimbursement for Multigene Tests for Cancer and Related Conditions
Fiscal Year: 2019
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Project Summary New technologies are enabling the use of genetic tests that measure multiple rather than single genes (gene panels and whole exome/genome sequencing tests). However, these tests raise questions such as: Will multigene tests be covered by insurers when appropriate so that there is neither overuse nor underuse because of cost? How will coverage, price, and reimbursement for multigene tests influence testing practices across diverse providers and clinical sites, particularly in safety net settings? Our objective is to examine “coverage, price, and reimbursement” (“CPR”) for multigene tests broadly and for cancer- related indications specifically: why tests are covered/not covered by payers, how this is changing over time, and how CPR influences testing decisions and practices in clinic settings. Specific aims are: 1) Examine publicly available payer coverage policies a) Analyze factors associated with coverage/non-coverage and how these are evolving (2015-2019), building from pilot data from our unique, systematic Payer Coverage Policy Registry b) Conduct in-depth analyses exploring why tests are covered/not covered, using data from payer interviews and a Symposium that engages payers, clinicians, and researchers 2) Examine influence of CPR on testing decisions and practices in clinic settings for cancer testing (germline and tumor) a) Conduct semi-structured interviews with genetic counselors, physicians, and clinic administrators in seven sites, including safety net and community clinics, to examine how CPR influences testing in actual practice across diverse providers and sites b) Conduct a national, quantitative survey of genetic counselors to obtain data on how CPR influences testing decisions and practices at the point of care. These synergistic Aims examine an important topic using an innovative, mixed-methods approach. We address why tests are covered/not covered, how this is changing over time, and how CPR influences testing practices by (1) analyzing systematic data on actual coverage policies (2) assessing the role of payers and providers – not only physicians but also genetic counselors and clinic administrators (3) examining seven diverse clinic sites – not only academic medical centers but also community and safety net clinics, and (4) analyzing data from a national survey of genetic counselors. Study outcomes will provide information on what issues need to be addressed and possible solutions, and contribute to the overarching objectives of developing policies and practices that are transparent, consistent, and equitable (regardless of whether tests are covered or not) and that will help patients have access to testing when clinically appropriate.

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Perspectives of US private payers on insurance coverage for pediatric and prenatal exome sequencing: Results of a study from the Program in Prenatal and Pediatric Genomic Sequencing (P3EGS).
Authors: Trosman J.R. , Weldon C.B. , Slavotinek A. , Norton M.E. , Douglas M.P. , Phillips K.A. .
Source: Genetics in medicine : official journal of the American College of Medical Genetics, 2019-09-10; , .
EPub date: 2019-09-10.
PMID: 31501586
Related Citations

Emergence of Hybrid Models of Genetic Testing Beyond Direct-to-Consumer or Traditional Labs.
Authors: Phillips K.A. , Trosman J.R. , Douglas M.P. .
Source: JAMA, 2019-06-25; 321(24), p. 2403-2404.
PMID: 31145414
Related Citations

From the Past to the Present: Insurer Coverage Frameworks for Next-Generation Tumor Sequencing.
Authors: Trosman J.R. , Weldon C.B. , Gradishar W.J. , Benson A.B. , Cristofanilli M. , Kurian A.W. , Ford J.M. , Balch A. , Watkins J. , Phillips K.A. .
Source: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2018 09; 21(9), p. 1062-1068.
EPub date: 2018-08-03.
PMID: 30224110
Related Citations

New Medicare Coverage Policy for Next-Generation Tumor Sequencing: A Key Shift in Coverage Criteria With Broad Implications Beyond Medicare.
Authors: Phillips K.A. , Trosman J.R. , Weldon C.B. , Douglas M.P. .
Source: JCO precision oncology, 2018; 2, .
EPub date: 2018-11-08.
PMID: 31073549
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