The FDA and CMS launched the RAPID coverage pathway to align regulatory authorization and Medicare national coverage timing for breakthrough medical devices. Under the program, CMS will issue a proposed national coverage determination the same day an eligible device receives FDA authorization, with a mandatory 30-day comment window. The agencies said the streamlined process could cut time to national coverage to as little as two months, compared with roughly a year or more under the current pathway. RAPID is limited to certain device classes and requires inclusion in specific FDA programs and Investigation Device Exemption studies enrolling Medicare beneficiaries. For device-focused biotech and med-tech innovators, RAPID is designed to reduce uncertainty and accelerate access immediately after authorization.