CMS Proposes RAPID Pathway to Accelerate Medicare Coverage for FDA-Approved Devices
CMS proposed the Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway to coordinate FDA device approval with Medicare coverage decisions, compressing a typical five-year lag to 60-90 days. The pathway synchronizes regulatory approval and coverage determination processes from the outset. Manufacturers of breakthrough devices would participate in joint FDA-CMS reviews. This matters for Medicaid managed care organizations and state agencies because accelerated Medicare coverage pathways often influence state Medicaid coverage decisions and MCO formulary policies for medical devices and durable medical equipment.
Faster Medicare coverage for breakthrough devices typically pressures state Medicaid programs and MCOs to update coverage policies and prior authorization protocols within months rather than years.
Managed Care
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