CMS and FDA are creating a fast-track Medicare coverage pathway for breakthrough devices
CMS and FDA are creating a fast-track Medicare coverage pathway for breakthrough devices
The RAPID pathway could cut the wait for Medicare coverage from over a year to about 2 months after FDA market authorization
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The Centers for Medicare & Medicaid Services and the Food and Drug Administration announced a new joint coverage pathway called the Regulatory Alignment for Predictable and Immediate Device, or RAPID, designed to speed Medicare access to certain FDA-designated Class II and Class III Breakthrough Devices.
Under the pathway, CMS will issue a proposed National Coverage Determination the same day an eligible device receives FDA market authorization, triggering a required........
