Both private payer and Medicare coverage for circulating tumor DNA (ctDNA) testing in cancer care is on the rise, with coverage policies becoming increasingly more inclusive of different cancer types and types of tests covered, found a recent study in the Journal of the National Comprehensive Cancer Network.

Study researchers reviewed private payer coverage policies and Medicare national coverage determinations and local coverage determinations for cancer ctDNA-based testing panels from January 1, 2015, through July 1, 2019.

The review revealed that neither private payers nor Medicare covered ctDNA testing in 2015 or 2016. The first coverage policy was not until 2017, when Blue Cross Blue Shield Massachusetts provided coverage for the Guardant360 ctDNA-based panel test for non-small cell lung cancer.

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However, by July 2019, 38% of private payer coverage policies had coverage for ctDNA-based panel testing. These coverage policies were primarily for lung cancer but also included solid and hematologic malignancies. The ctDNA tests covered included comprehensive gene analysis using Guardant360 and single-gene EGFR analysis using cobas EGFR Mutation Test v2, Guardant360, or OncoBEAM.

Although no national coverage determinations in Medicare provide ctDNA testing coverage, 12 local coverage determinations as of 2019 do — up from 4 in 2018 and zero in previous years. The type of cancers covered by local coverage determinations in 2019 were primarily lung cancer but also included solid tumors.

According to the study authors, the coverage for Medicare local coverage determinations are “evolving” from “coverage of specific cancers to policies providing coverage of pan-cancer scenarios.”

One “conundrum” that the study authors found was that several payers provide coverage for multigene tests — such as Guardant360 — but only allow interpretation of a single gene — such as EGFR. This “leads to a report that may have results that are not covered by the payer but may still be used to inform the clinician’s ability to properly manage the patient’s cancer,” the study authors wrote.


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;18(7):866-872.