US Plans to Speed Insurance Coverage for Medical Devices

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. 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.