FDA and CMS Announce Faster Coverage Pathway for Breakthrough Medical Devices
The FDA and Centers for Medicare and Medicaid Services announced a new program that could reduce insurance coverage timelines for innovative medical devices from over a year to as little as two months, helping patients access breakthrough treatments faster.
New Regulatory Alignment Program
Breakthrough medical devices will get faster insurance coverage in the US under a new government program that coordinates coverage with the approval process, streamlining one of the biggest hurdles for patient access and industry sales. The Centers for Medicare and Medicaid Services and the US 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.
Program Details
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
One of the biggest hurdles for medical device companies is the length of time it takes to get insurance coverage for their products, something that can add years to the development process. And it's often scattershot, with patients in some areas getting access while others still wait.