Medicare Will Test Payment Model For Accelerated Approvals To ‘Expedite’ Confirmatory Trials
The Center for Medicare and Medicaid Innovation also will develop demonstrations focused on payment arrangements for cell and gene therapy in Medicaid and promoting generic drugs in Medicare Part D.
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But CMMI does not yet have a launch date for the proposed Medicare demonstration on drugs cleared through FDA’s accelerated approval pathway and the demonstration allowing Part D plans to offer certain high-value generics with a $2 beneficiary copay.
CMS’ innovation center creates new division to test alternative payment models, including likely new approaches for accelerated approval drugs and multi-state outcomes-based payment arrangements for cell and gene therapy in Medicaid.
Recommendation meant to drive completion of confirmatory trials for accelerated approvals will be forwarded to Congress. Medicare Payment Advisory Commission also recommends allowing Part B to use reference pricing and to adjust ASP payment add-ons for providers.