CMS and FDA announce RAPID pathway to accelerate Medicare coverage for breakthrough devices

CMS and the FDA launched the RAPID Coverage Pathway, a joint initiative designed to expedite Medicare coverage for FDA-designated breakthrough medical devices. The program aims to reduce the gap between FDA approval and Medicare national coverage decisions, which historically can take years. It will prioritize devices treating life-threatening or irreversibly debilitating conditions. The agencies will establish parallel review frameworks and dedicated points of contact. This shift signals CMS's push to align coverage policy more closely with the pace of therapeutic innovation.