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Grant Details

Grant Number: 5R01CA221870-03 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: 2020
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Abstract

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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Publications

Private Payer and Medicare Coverage for Circulating Tumor DNA Testing: A Historical Analysis of Coverage Policies From 2015 to 2019.
Authors: Douglas M.P. , Gray S.W. , Phillips K.A. .
Source: Journal of the National Comprehensive Cancer Network : JNCCN, 2020 Jul; 18(7), p. 866-872.
PMID: 32634780
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Addressing Challenges of Economic Evaluation in Precision Medicine Using Dynamic Simulation Modeling.
Authors: Marshall D.A. , Grazziotin L.R. , Regier D.A. , Wordsworth S. , Buchanan J. , Phillips K. , Ijzerman M. .
Source: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2020 May; 23(5), p. 566-573.
EPub date: 2020-03-26.
PMID: 32389221
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Quantifying Downstream Healthcare Utilization in Studies of Genomic Testing.
Authors: Mackay Z.P. , Dukhovny D. , Phillips K.A. , Beggs A.H. , Green R.C. , Parad R.B. , Christensen K.D. , BabySeq Project Team .
Source: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2020 May; 23(5), p. 559-565.
EPub date: 2020-03-20.
PMID: 32389220
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Insights From a Temporal Assessment of Increases in US Private Payer Coverage of Tumor Sequencing From 2015 to 2019.
Authors: Trosman J.R. , Douglas M.P. , Liang S.Y. , Weldon C.B. , Kurian A.W. , Kelley R.K. , Phillips K.A. .
Source: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2020 May; 23(5), p. 551-558.
EPub date: 2020-03-19.
PMID: 32389219
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Use of Real-World Evidence in US Payer Coverage Decision-Making for Next-Generation Sequencing-Based Tests: Challenges, Opportunities, and Potential Solutions.
Authors: Deverka P.A. , Douglas M.P. , Phillips K.A. .
Source: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2020 May; 23(5), p. 540-550.
EPub date: 2020-03-26.
PMID: 32389218
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Methods for Moving the Evaluation of Precision Medicine Into Practice and Policy.
Authors: Phillips K.A. .
Source: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2020 May; 23(5), p. 527-528.
EPub date: 2020-04-17.
PMID: 32389216
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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, 2020 02; 22(2), p. 283-291.
EPub date: 2019-09-10.
PMID: 31501586
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Can precision medicine help achieve the goal of reducing care when the risks exceed the benefits?
Authors: Phillips K.A. , Marshall D.A. , Kurian A.W. .
Source: Personalized medicine, 2019 09; 16(5), p. 365-367.
EPub date: 2019-09-25.
PMID: 31552799
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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
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A Practical First Step Using Needs Assessment and a Survey Approach to Implementing a Clinical Pharmacogenomics Consult Service.
Authors: Zakinova A. , Long-Boyle J.R. , French D. , Croci R. , Wilson L. , Phillips K.A. , Kroetz D.L. , Shin J. , Tamraz B. .
Source: Journal of the American College of Clinical Pharmacy : JACCP, 2019 Jun; 2(3), p. 214-221.
EPub date: 2018-11-22.
PMID: 32391517
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The Global Market for Next-Generation Sequencing Tests Continues Its Torrid Pace.
Authors: Phillips K.A. , Douglas M.P. .
Source: The Journal of precision medicine, 2018 Oct; 4, .
PMID: 32149190
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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
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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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