CMS details new RAPID pathway for expedited Medicare coverage of breakthrough devices

CMS published the final rule for its Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, creating a parallel process for FDA-designated breakthrough devices. The rule outlines new evidentiary standards and a binding coverage determination process meant to reduce the lag between FDA approval and Medicare payment. This creates a new billing and coding framework for innovative devices entering the market. The program is voluntary for manufacturers. Clinics and hospitals using or planning to adopt new breakthrough technologies should monitor the FDA's breakthrough device list and subsequent CMS coverage decisions published under this new pathway.