Medicare Final CAR-T Policy Eases Coverage Requirements
Product developers and researchers applaud the changes, including dropping "coverage with evidence development" approach.
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Medicare may look to bolster evidence on Biogen’s potential Alzheimer’s treatment, if approved, with a national coverage decision requiring the collection of clinical data in the postmarket setting.
Proposed rule would also clarify standard for determining whether coverage of a drug, device, or biologic is ‘reasonable and necessary.’
Legislation allows sponsors to request HCPCS code even before US FDA approval, but would extend the sequester until 2030 to pay for the temporary increase in payments for Part B drugs.