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CAR-T Therapy In Medicare: National Coverage Policy Could Come In 2019

Executive Summary

Medicare begins analysis process for CAR-T cancer therapies in response to a request from UnitedHealthcare for a national coverage policy.

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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.

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Medicare Evidence Development and Coverage Advisory Committee votes that four existing tools are valid and could be “generalizable” to Medicare beneficiaries.

CAR-T Reimbursement Threatened By Medicare Coverage Analysis, Manufacturers Say

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