New Coverage Pathway To Speed Medicare Beneficiary Access To Breakthrough Medical Devices

The Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) launched a coordinated review process to accelerate Medicare beneficiary access to breakthrough medical devices through the new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. Through RAPID, CMS will issue a proposed National Coverage Determination (NCD) the same day an eligible device participating in this pathway receives FDA market authorization, triggering the required 30-day public comment period.

CMS stated the pathway could reduce the time to Medicare coverage to approximately two months after FDA market authorization. The current pathway takes a year . . .