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Lab Industry, Cancer Groups Want Expanded Medicare Coverage Of NGS For Advanced Cancers

 
• By Sue Darcey

While device firms that create lab test kits, clinical laboratories and cancer medicine groups supported US Centers for Medicare and Medicaid Services' proposed national coverage determination for use of next generation sequencing (NGS) for advanced cancer tests in recent comments, they want the agency to modify its approach to the NCD in one way or another and, in many cases, expand it. A final coverage decision is imminent.

PCR strip test tubes and micropipette in genetics laboratory. Toned photo

With a final coverage determination imminent on next-generation sequencing (NGS) for beneficiaries with advanced cancer, the laboratory industry, test kit makers, and cancer-focused medical societies generally support elements of a CMS proposal issued last year. However, many want to see some restrictions removed that could make easier for more NGS to be covered by Medicare in the future. There are also some that want a more narrowly defined approach to ensure that only solid tumor tissue-based testing, and not blood sample testing, can be carried out under that NCD.

CMS issued a draft national coverage determination on Nov. 30, 2017 in parallel to FDA approval of Foundation Medicine Inc.'s Foundation One CDx, a multi-drug companion diagnostic test, via...

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