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CMS collecting comments on RAPID pathway for device coverage
The Centers for Medicare and Medicaid Services (CMS) is accepting comments on its proposal to speed up manufacturers’ ability to get new devices covered by Medicare. The Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, first announced by CMS and the Food and Drug Administration (FDA) in April, will accelerate beneficiary access to eligible Class II FDA-designated Breakthrough Devices participating in FDA’s Total Product Life Cycle Advisory Program (TAP) and to eligible Class III FDA-designated Breakthrough Devices (regardless of TAP participation).
The RAPID coverage pathway is designed to reduce the review time between when the FDA authorizes a device for the market and when Medicare issues a national coverage determination (NCD). For devices in the RAPID coverage pathway, a proposed NCD will be issued the same day as FDA market authorization, meaning that national Medicare coverage could begin as soon as 60 days after FDA market authorization.
The public can comment on the procedural notice until Oct. 13.