Background: Clinical adoption of the sequencing of circulating tumor DNA (ctDNA) for cancer has rapidly increased in recent years. This sequencing is used to select targeted therapy and monitor nonresponding or progressive tumors to identify mechanisms of therapeutic resistance. Our study objective was to review available coverage policies for cancer ctDNA–based testing panels to examine trends from 2015 to 2019. Methods: We analyzed publicly available private payer policies and Medicare national coverage determinations and local coverage determinations (LCDs) for ctDNA-based panel tests for cancer. We coded variables for each year representing policy existence, covered clinical scenario, and specific ctDNA test covered. Descriptive analyses were performed. Results: We found that 38% of private payer coverage policies provided coverage of ctDNA-based panel testing as of July 2019. Most private payer policy coverage was highly specific: 87% for non–small cell lung cancer, 47% for EGFR gene testing, and 79% for specific brand-name tests. There were 8 final, 2 draft, and 2 future effective final LCDs (February 3 and March 15, 2020) that covered non–FDA-approved ctDNA-based tests. The draft and future effective LCDs were the first policies to cover pan-cancer use. Conclusions: Coverage of ctDNA-based panel testing for cancer indications increased from 2015 to 2019. The trend in private payer and Medicare coverage is an increasing number of coverage policies, number of positive policies, and scope of coverage. We found that Medicare coverage policies are evolving to pan-cancer uses, signifying a significant shift in coverage frameworks. Given that genomic medicine is rapidly changing, payers and policymakers (eg, guideline developers) will need to continue to evolve policies to keep pace with emerging science and standards in clinical care.
Submitted October 11, 2019; accepted for publication January 29, 2020.
Author contributions:Study concept or design: Douglas, Phillips. Data acquisition, analysis, or interpretation: All authors. Manuscript preparation or critical revision: All authors.
Disclosures: Mr. Douglas has disclosed that he receives consulting fees from Illumina, Inc. Dr. Gray has disclosed that she has not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article. Dr. Phillips has disclosed that she receives consulting fees from Illumina, Inc., and received consulting fees from Lexent Bio, Inc.
Funding: This work was supported by grants from the National Cancer Institute (R01 CA221870) and the National Human Genome Research Institute (U01 HG009599) to Dr. Phillips.
Disclaimer: The National Human Genome Research Institute and the National Cancer Institute had no role in the preparation, review, or approval of the manuscript or decision to submit the manuscript for publication.
Correspondence: Michael P. Douglas, MS, Department of Clinical Pharmacy, UCSF Center for Translational and Policy Research on Personalized Medicine, 3333 California Street, Room 420, Box 0613, San Francisco, CA 94143. Email: email@example.com
MerkerJD, OxnardGR, ComptonC, . Circulating tumor DNA analysis in patients with cancer: American Society of Clinical Oncology and College of American Pathologists joint review. J Clin Oncol2018;36:1631–1641.
MerkerJD, OxnardGR, ComptonC, . Circulating tumor DNA analysis in patients with cancer: American Society of Clinical Oncology and College of American Pathologists joint review. J Clin Oncol 2018;36:1631–1641.10.1200/JCO.2017.76.8671)| false
DouglasMP, ParkerSL, TrosmanJR, . Private payer coverage policies for exome sequencing (ES) in pediatric patients: trends over time and analysis of evidence cited. Genet Med 2019;21:152–160.10.1038/s41436-018-0043-329997388)| false
TrosmanJR, WeldonCB, SlavotinekA, . 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 Med2020;22:283–291.
TrosmanJR, WeldonCB, SlavotinekA, . 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;22:283–291.3150158610.1038/s41436-019-0650-7)| false
Blue Cross Blue Shield Association. Evidence Street: Circulating tumor DNA and circulating tumor cells for cancer management (liquid biopsy). Accessed June 5, 2020. Available at: https://app.evidencestreet.com/
TrosmanJR, DouglasMP, LiangSY, . Insights from a temporal assessment of increases in U.S. private payer coverage of tumor sequencing from 2015 to 2019. Value Health2020;23:551–558.
TrosmanJR, DouglasMP, LiangSY, . Insights from a temporal assessment of increases in U.S. private payer coverage of tumor sequencing from 2015 to 2019. Value Health 2020;23:551–558.3238921910.1016/j.jval.2020.01.018)| false
TrosmanJR, Van BebberSL, PhillipsKA. Coverage policy development for personalized medicine: private payer perspectives on developing policy for the 21-gene assay. J Oncol Pract 2010;6:238–242.2119718710.1200/JOP.000075)| false
TrosmanJR, WeldonCB, GradisharWJ, . From the past to the present: insurer coverage frameworks for next-generation tumor sequencing. Value Health 2018;21:1062–1068.3022411010.1016/j.jval.2018.06.011)| false
TrosmanJR, WeldonCB, DouglasMP, . Payer coverage for hereditary cancer panels: barriers, opportunities, and implications for the Precision Medicine Initiative. J Natl Compr Canc Netw 2017;15:219–228.10.6004/jnccn.2017.002228188191)| false