Medicare Advisers Endorse Patient Reported Outcomes For CAR-T With Caveats
Medicare Evidence Development and Coverage Advisory Committee votes that four existing tools are valid and could be “generalizable” to Medicare beneficiaries.
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Product developers and researchers applaud the changes, including dropping "coverage with evidence development" approach.
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.