CMS, FDA announce pathway to expedite access to certain medical devices for Medicare beneficiaries

The Centers for Medicare & Medicaid Services and the Food and Drug Administration April 23 announced a new pathway to expedite access to certain FDA-designated Class II and Class III devices for Medicare beneficiaries. The Regulatory Alignment for Predictable and Immediate Device coverage pathway, or RAPID, is designed to reduce delays between FDA market authorization and Medicare national coverage determinations, the agencies said. The pathway is for devices that address unmet medical needs and is available for certain Class II devices participating in the FDA Total Product Life Cycle Advisory Program, also known as TAP, and Class III devices regardless of TAP participation. The agencies said a Federal Register notice will be published outlining the RAPID coverage pathway, in which the public will have 60 days to provide comments.