Grant Summary: Coverage, Price, and Reimbursement for Multigene Tests for Cancer and Related Conditions
This grant examined the role of price and reimbursement on decision-making for multigene testing for cancer risk screening and treatment. Using mixed methods, we examined (1) factors associated with coverage based on published coverage policies and interviews, and (2) influence of economic factors on testing decisions in clinics based on interviews and surveys with safety-net providers and genetic counselors. We also received a one-year supplement (from NCI but funded by NIA) to broaden our focus to examine the economic, financial/coverage, and policy implications of genetic testing for Alzheimer’s Disease and related dementias.
Three key takeaways:
- The application of genomic medicine for cancer risk screening and for targeting cancer therapies has evolved substantially, with greater payer coverage over time in many (but not all) clinical scenarios.
- The growth of genomic medicine is impacted by the evolving nature of the lab industry, with the emergence of hybrid labs that fall into a middle ground between direct-to-consumer labs and traditional labs and the growth of low cost or subsidized testing that has increased access but may not be sustainable.
- There remain gaps in the evidence base needed for implementation including limited data on test utilization and use of real-world data, insufficient studies on economic value and affordability, not enough attention paid to how testing is actually implemented into clinical care and the patient/provider relationship, and little emphasis yet on how emerging technologies such as cell-free DNA tests and polygenic risk scores will be applied in clinical settings.
This grant produced 29 papers, and 1 in-press, including papers in JAMA (N=2), Science, JNCCN, Health Affairs, Genetics in Medicine (N=5), and Value in Health (theme section of 6 papers).
- Phillips KA. CMS Coverage with Evidence Development: Challenges & Opportunities for Improvement. JAMA Health Forum. Accepted, pending publication.
- Arias JJ, Lin GA, Tyler AM, Douglas MP, Phillips KA. Geriatricians’ Perspectives on the Multiple Dimensions of Utility of Genetic Testing for Alzheimer’s Disease: A Qualitative Study. Alzheimers Dis. 2022 Jul 20;. [Epub ahead of print] NIHMSID: NIHMS1829103.
- Weldon CB, Trosman JR, Liang S-Y, Douglas MP, Scheuner MT, Kurian AW, Schaa K, Roscow B, Erwin D, Phillips KA. Genetic Counselors’ experience with reimbursement and patient out-of-pocket cost for multi-cancer gene panel testing for hereditary cancer syndromes. J Genetic Counseling. 2022. Jul 28; [Epub ahead of print] NIHMSID:NIHMS1818893.
- Deverka PA, Douglas MP, Phillips KA. Multicancer Screening Tests: Anticipating And Addressing Considerations For Payer Coverage And Patient Access. Health Aff (Millwood). 2022 Mar;41(3):383-389. PMCID: PMC8962120.
- Jansen JP, Trikalinos TA, Phillips KA. Assessments of the Value of New Interventions Should Include Health Equity Impact. Pharmacoeconomics. 2022 May;40(5):489-495. PMCID: PMC8890816.
- Phillips KA, Trosman JR, Douglas MP, Gelb BD, Ferket BS, Hindorff LA, Slavotinek AM, Berg JS, Russell HV, Devine B, Greve V, Smith HS. US private payers' perspectives on insurance coverage for genome sequencing versus exome sequencing: A study by the Clinical Sequencing Evidence-Generating Research Consortium (CSER). Genet Med. 2022 Jan;24(1):238-244. PMCID: PMC8962136.
- Douglas MP, Lin GA, Trosman JR, Phillips KA. Hereditary cancer panel testing challenges and solutions for the latinx community: costs, access, and variants. J Community Genet. 2022 Feb;13(1):75-80. PMCID: PMC8799811.
- Lin GA, Trosman JR, Douglas MP, Weldon CB, Scheuner MT, Kurian A, Phillips KA. Influence of payer coverage and out-of-pocket costs on ordering of NGS panel tests for hereditary cancer in diverse settings. J Genet Couns. 2022 Feb;31(1):130-139. PMCID: PMC8893352.
- Phillips KA, Douglas MP, Wordsworth S, Buchanan J, Marshall DA. Availability and funding of clinical genomic sequencing globally. BMJ Glob Health. 2021 Feb;6(2):e004415. PMCID: PMC7880109.
- Jones KM, Cook-Deegan R, Rotimi CN, Callier SL, Bentley AR, Stevens H, Phillips KA, Jansen JP, Weyant CF, Roberts DE, Zielinski D, Erlich Y, Garrison NA, Carroll SR, Ossorio PN, Moreau Y, Wang M. Complicated legacies: The human genome at 20. Science. 2021 Feb 5;371(6529):564-569. PMCID: PMC8011351.
- Arias JJ, Tyler AM, Douglas MP, Phillips KA. Private payer coverage policies for ApoE-e4 genetic testing. Genet Med. 2021 Apr;23(4):614-620. PMCID: PMC8035237.
- Phillips KA, Douglas MP, Marshall DA. Expanding Use of Clinical Genome Sequencing and the Need for More Data on Implementation. JAMA. 2020 Nov 24;324(20):2029-2030. PMCID: PMC7686292.
- Douglas MP, Gray SW, Phillips KA. Private Payer and Medicare Coverage for Circulating Tumor DNA Testing: A Historical Analysis of Coverage Policies From 2015 to 2019. J Natl Compr Canc Netw. 2020 Jul;18(7):866-872. PMCID: PMC7347155.
- Phillips KA. Methods for Moving the Evaluation of Precision Medicine Into Practice and Policy. Value Health. 2020 May;23(5):527-528. PMCID: PMC7217974.
- Trosman JR, Douglas MP, Liang SY, Weldon CB, Kurian AW, Kelley RK, Phillips KA. Insights From a Temporal Assessment of Increases in US Private Payer Coverage of Tumor Sequencing From 2015 to 2019. Value Health. 2020 May;23(5):551-558. PMCID: PMC7217867.
- Mackay ZP, Dukhovny D, Phillips KA, Beggs AH, Green RC, Parad RB, Christensen KD; BabySeq Project Team. Quantifying Downstream Healthcare Utilization in Studies of Genomic Testing. Value Health. 2020 May;23(5):559-565. PMCID: PMC7293136.
- Phillips KA, Marshall DA, Kurian AW. Can precision medicine help achieve the goal of reducing care when the risks exceed the benefits? Per Med. 2019 Sep;16(5):365-367. PMCID: PMC6785357.
- Marshall DA, Grazziotin LR, Regier DA, Wordsworth S, Buchanan J, Phillips K, Ijzerman M. Addressing Challenges of Economic Evaluation in Precision Medicine Using Dynamic Simulation Modeling. Value Health. 2020 May;23(5):566-573. PMCID: PMC7218800.
- Deverka PA, Douglas MP, Phillips KA. Use of Real-World Evidence in US Payer Coverage Decision-Making for Next-Generation Sequencing-Based Tests: Challenges, Opportunities, and Potential Solutions. Value Health. 2020 May;23(5):540-550. PMCID: PMC7219085.
- Phillips KA, Trosman JR, Weldon CB, Douglas MP. New Medicare Coverage Policy for Next-Generation Tumor Sequencing: A Key Shift in Coverage Criteria With Broad Implications Beyond Medicare. JCO Precis Oncol. 2018;2:PO.18.00206. PMCID: PMC6503521.
- Trosman JR, Weldon CB, Slavotinek A, Norton ME, Douglas MP, Phillips KA. 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). Genet Med.2020;22(2): 283-291. PMC7004856.
- Phillips KA, Trosman JR, Douglas MP. Emergence of Hybrid Models of Genetic Testing Beyond Direct-to-Consumer or Traditional Labs. JAMA. 2019 Jun 25;321(24):2403-2404. PMCID: PMC6684382.
- Scheuner MT, Douglas MP, Sales P, Ackerman SL, Phillips KA. Laboratory business models and practices: implications for availability and access to germline genetic testing. Genet Med. 2021 Sep;23(9):1681-1688. PMCID: PMC8460432.
- Zakinova A, Long-Boyle JR, French D, Croci R, Wilson L, Phillips KA, Kroetz DL, Shin J, Tamraz B. A Practical First Step Using Needs Assessment and a Survey Approach to Implementing a Clinical Pharmacogenomics Consult Service. J Am Coll Clin Pharm. 2019 Jun;2(3):214-221. PMCID: PMC7207007.
- Phillips KA, Douglas MP. The Global Market for Next‑Generation Sequencing Tests Continues Its Torrid Pace. J Precision Medicine. November 2018.
- Phillips KA. “The Coming Era Of Precision Health.” Health Affairs Blog. https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2020.02393
- Phillips KA, Deverka PA. “Policy Implications of Commercial Payer Use of Third Party Benefit Managers: The Example of the Emerging Role of Lab Benefit Managers for Genetic Testing.” Health Affairs Blog. https://www.healthaffairs.org/do/10.1377/hblog20191021.563154/full
- Arias JJ, Phillips KA, Karlawish J. Developing an Economic and Policy Research Agenda for Blood Biomarkers of Neurodegenerative Diseases. JAMA Health Forum. https://jamanetwork.com/journals/jama-health-forum/fullarticle/2782056
- Phillips KA, Kroon LA, Bibbins-Domingo K, Douglas MP, Reyes KL. Pharmacies for Covid-19 Care. Public Health Post. https://www.publichealthpost.org/research/pharmacies-for-covid-19-care/
- Phillips KA, Lin GA. What’s Missing in the Controversy Over FDA Approval of the New Alzheimer’s Drug: How Will Patients be Screened to Determine if they are Eligible for Treatment? Health Affairs Blog. https://www.healthaffairs.org/do/10.1377/hblog20210830.474376/full/