CMS, FDA Launch 'RAPID' Coverage Pathway for Breakthrough Medical Devices

CMS and the FDA jointly announced the RAPID Coverage Pathway, a new process to accelerate Medicare coverage for FDA-designated breakthrough devices. The pathway allows for parallel review and aims to reduce the lag between FDA approval and Medicare reimbursement decisions from years to potentially months. It applies to a select group of devices that address unmet medical needs. For practices, this means certain advanced diagnostics and therapeutics may become billable to Medicare sooner after market entry. The first devices under this pathway are expected in 2027.