CMS and FDA Announce Faster Medicare Coverage Pathway for Breakthrough Medical Devices
Federal regulators announced a new Medicare coverage process designed to speed up reimbursement for medical devices the FDA designates as breakthrough innovations. The initiative aims to close a median six-year gap between FDA authorization and Medicare coverage.
New RAPID Coverage Pathway for Breakthrough Devices
Federal regulators are proposing a new, faster Medicare coverage pathway for medical devices deemed by the FDA as breakthroughs. Federal regulators on Thursday announced a new Medicare coverage pathway for devices deemed breakthroughs by the Food and Drug Administration.
Addressing Industry Delays
The program aims to address longstanding industry complaints that it takes too long for Medicare to pay for innovative technology. A new initiative from FDA Commissioner Makary and CMS Administrator Oz aims to close the long gap — a median of nearly six years — between FDA authorization of breakthrough medtech and Medicare coverage.
Program Details
The new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway would "expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare."