FDA and CMS Launch Fast-Track Program for Breakthrough Medical Devices
The FDA and Centers for Medicare and Medicaid Services announced a new program called RAPID that speeds up insurance coverage for innovative medical devices. The initiative could reduce time to coverage from over a year to just two months, helping patients access breakthrough treatments faster.
New Coverage Pathway Accelerates Device Access
Breakthrough medical devices will get faster insurance coverage in the U.S. under a new government program that coordinates coverage with the approval process. The Centers for Medicare and Medicaid Services and the U.S. Food and Drug Administration unveiled the new coverage pathway on Thursday, saying it could result in insurance coverage of the most innovative devices in as little as two months, down from more than a year.
How RAPID Program Works
The Regulatory Alignment for Predictable and Immediate Device, or Rapid, applies to breakthrough technology that addresses unmet medical needs and already undergoes a quicker FDA review. It aligns FDA reviews and CMS coverage, bringing the insurance component in earlier during the development process.
Impact on Patient Access
"The American people deserve timely access to meaningful treatments without red tape or high costs," FDA Commissioner Marty Makary said in a statement.