The Centers for Medicare & Medicaid Services (CMS) has issued a proposed procedural notice detailing its Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, moving forward with a concept first announced jointly with the Food & Drug Administration (FDA) in April.
RAPID is intended to shorten the time between FDA market authorization and Medicare coverage for eligible breakthrough medical devices. The pathway aligns CMS and FDA evidence requirements earlier in the development and review process, allowing the agencies to conduct aspects of their assessments in parallel.
Under the proposed process, CMS could issue a proposed national coverage determination (NCD) on the same day that the FDA grants market authorization. Medicare coverage could subsequently begin as soon as 60 days after FDA authorization. CMS has opened a 60-day public comment period on the pathway’s operational framework.
RAPID will apply to FDA-designated Breakthrough Devices that address unmet medical needs among Medicare beneficiaries. Eligible technologies include all Class III devices and certain Class II devices participating in the FDA’s Total Product Life Cycle Advisory Program (TAP).
The FDA’s Breakthrough Devices Program supports accelerated development, assessment and review of devices that may offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases and conditions. Technologies receiving breakthrough designation can include continuous glucose monitors, pulsed field ablation systems, AI-enabled diagnostic software and robotic surgical platforms.
In vitro diagnostic (IVD) products will not be eligible for RAPID. CMS said these products involve a specialized area of coverage policy development and noted that it has historically delegated review of many IVDs to specialized Medicare Administrative Contractors. That approach will continue.
Congress established the FDA Breakthrough Devices Program through the 21st Century Cures Act of 2016. CMS and the FDA announced RAPID in April as a framework for coordinating regulatory and Medicare coverage reviews. The new procedural notice provides further detail on how the pathway would operate.
As of March 31, the FDA’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research had granted 1,284 Breakthrough Device designations.
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