Though a significant shift in coverage frameworks was detected in this study, future research should continue to monitor coverage and its possible impact on test utilization.
A historical analysis of private payer and Medicare coverage for circulating tumor DNA (ctDNA) testing, published in the Journal of the National Comprehensive Cancer Network, found that coverage of the panel testing for cancer indications increased from 2015 to 2019.
Overall, the investigators also found that Medicare coverage policies are evolving to pan-cancer uses, which represents a significant shift in coverage frameworks. However, future research should continue to track coverage and evaluate its impact on test utilization.
“Given that genomic medicine is rapidly changing, payers and policymakers will need to continue to evolve policies to keep pace with emerging science and standards in clinical care,” the authors wrote.
Using publicly available private payer policies and Medicare national coverage determinations (NCDs) and local coverage determinations (LCDs), researchers sought to determine available coverage policies for cancer ctDNA-based testing panels. Variables were coded for each year representing policy existence, covered clinical scenario, and specific ctDNA test covered.
Ultimately, 38% of private payer coverage policies provided coverage of ctDNA-based panel testing as of July 2019. However, most private payer policy coverage was very specific, with 87% specifying for non-small cell lung cancer (NSCLC), 47% for EGFR gene testing, and 79% for specific-brand-name tests.
“Given that tests such as these are panel tests that evaluate multiple genes, the “limited” coverage decision may actually result in testing that is far more comprehensive than intended,” the authors wrote.
Notably, Medicare coverage policies were found to be evolving rapidly. Although there is no NCD policy which explicitly provides coverage for ctDNA-based panel tests, other than for FDA-approved tests, coverage is provided through LCDs.
“The policy framework for Medicare LCDs is evolving from coverage of specific cancers to policies providing coverage of pan-cancer scenarios, which marks a significant change from earlier LCDs,” the authors wrote.
According to the researchers, these results suggest that there is a conundrum between what the test actually evaluates, what the payer is willing to cover, and the information that the clinician receives and can use to guide clinical decisions. Additionally, limited policies, or having no policy, may task clinicians with prior authorization requirements and appeals and therefore delay or prevent access to testing. The investigators indicated that these issues, among others, will require further evaluation.
Importantly, there were 8 final, 2 draft, and 2 future effective final LCDs identified, which are now effective as of February 3 and March 15, 2020, that covered non-FDA-approved ctDNA-based tests. The draft and future effective LCDs were the first policies created to cover pan-cancer use.
“Although there has been a plethora of coverage for the use of ctDNA testing in NSCLC from both private payers and Medicare, the coverage has been primarily for treatment selection, with only 11% of payers with positive coverage including any monitoring indications,” the authors wrote. “We expect that coverage may eventually be added for additional clinical indications, such as monitoring of minimal residual disease after definitive therapy or for detecting recurrence, although payers may be reluctant to adopt these indications because this would expand use to more extensive serial testing over time and thus may greatly increase costs.”
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. doi: 10.6004/jnccn.2020.7542.