Medicare CAR-T Coverage Decision Appears Hung Up In Political Review, Former CMS Official Says
Proliferation of expensive accelerated approval products requires "a revision to the existing evidence and policy approach for payers," Sean Tunis tells the DIA annual meeting.
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As final decision looms, initial move to hold off on DRG but increase payment for CAR-T therapies shows CMS taking a slow and steady approach to paying for the products.
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.
Association for Accessible Medicines’ interim leader is General Counsel Jeffrey Francer; Chip Davis’ four-and-half year tenure included a total rebrand of the association, a significant legislative victory with the CREATES act – and an abrupt departure for the Healthcare Distribution Alliance.