Center for Translational and Policy Research on Precision Medicine
TRANSPERS Study Finds Increase in Coverage for Liquid Biopsy (ctDNA sequencing) for both Private Payers and Medicare - but Broader Pan-Cancer Coverage under Medicare
Tue Jul 7, 2020
TRANSPERS has published the first study on coverage for Liquid Biopsy (circulating tumor DNA sequencing - "ctDNA") by private payers and Medicare in JNCCN and highlighted in a press release. Clinical adoption of the sequencing of ctDNA for cancer by testing bodily fluids has rapidly grown in recent years. These assays are particularly valuable in situations where testing needs to be performed rapidly and when tissue-based samples are unavailable. These so-called "liquid biopsy" tests are used to select targeted therapy and monitor non-responding or progressive tumors.
We found rapid increases in coverage for ctDNA sequencing among both private payers and Medicare - but broader pan-cancer coverage under Medicare. Private payers and Medicare began to issue coverage policies for ctDNA sequencing beginning in 2015 and 2017, respectively. Coverage has greatly increased from 2015 to 2019 in private payers with 38% covering (N=200 payers) and Medicare issuing 12 positive coverage Local Coverage Determinations (LCDs for both Non-small Cell Lung Cancer (NSCLC) and Pan-cancer (12 cancer types). Of the positive private payer policies (N=28), the majority (86%) were for NSCLC and only 4 provided coverage for pan-cancer indications. Of the seven Medicare Administrative Contractors, four have provided coverage for pan-cancer indications.
The overall trend for both private payer and Medicare is an increasing number of coverage policies, positive policies, and scope of coverage. The majority of the positive coverage policies are very specifically written with defined clinical scenarios. However, Medicare coverage policies are evolving to pan-cancer uses, which is signifying a significant shift in coverage frameworks.
Ultimately, both private and Medicare coverage policies have to keep up with changing technologies such as ctDNA sequencing. Liquid biopsy tests are key areas of interest as they move into broader use not just by cancer patients but also among healthy individuals for early cancer detection.