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Private Payer and Medicare Coverage for Circulating Tumor DNA Testing: A Historical Analysis of Coverage Policies from 2015 – 2019
- Source :
- J Natl Compr Canc Netw
- Publication Year :
- 2020
-
Abstract
- 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.
- Subjects :
- 0301 basic medicine
MEDLINE
Medicare
Article
Insurance Coverage
Circulating Tumor DNA
03 medical and health sciences
0302 clinical medicine
Neoplasms
Medicine
Genomic medicine
Humans
Clinical scenario
Pace
Aged
Actuarial science
business.industry
Guideline
Therapeutic resistance
United States
030104 developmental biology
Policy
Oncology
Circulating tumor DNA
030220 oncology & carcinogenesis
Non small cell
business
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- J Natl Compr Canc Netw
- Accession number :
- edsair.doi.dedup.....a655c769b4d155a65423f10d3de3d89c