CMS and FDA Launch RAPID Pathway to Speed Medicare Coverage for Breakthrough Devices

The program links Medicare coverage timing to FDA decisions to end years-long waits.

Overview

Federal regulators unveiled the RAPID pathway for select FDA Breakthrough Devices, cutting the typical Medicare coverage wait from a year or more to as little as two months.
Under RAPID, CMS will issue a proposed national coverage determination the same day a qualifying device receives FDA market authorization, starting a 30-day public comment period.
Eligibility is limited to Breakthrough Devices that meet unmet needs for Medicare patients, with Class II devices in FDA’s TAP program and all Class III devices able to participate.
Manufacturers must run an FDA- and CMS-specified IDE study that enrolls Medicare beneficiaries and measures agreed clinical outcomes to support coverage.
CMS and FDA paused new candidates for the TCET pathway and will set RAPID’s effective date after a final notice following a 60-day comment window, a shift meant to ease the long “valley of death” between approval and access.