Medicare Coverage For CAR-T Will Require Additional Patient Data Collection

Draft national coverage decision addresses current indications and hospital sites of care. CMS expects to “leverage” existing FDA post-market data collection requirements but seeks additional data on patient-reported outcomes in some cases.

CART

The Centers for Medicare and Medicaid Services issued a proposed national coverage determination for chimeric antigen receptor T-Cell (CAR-T) therapies Feb. 15 that links Medicare coverage to CMS-approved patient registries or clinical trials extending two years post treatment.

The proposed requirement, known as coverage with evidence development (CED), is meant to ensure that Medicare patients receiving the novel...

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