The U.S. FDA and the Centers for Medicare & Medicaid Services (CMS) announced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway to speed Medicare coverage for breakthrough medical devices. The program is designed to connect FDA authorization timing with Medicare national coverage decisions. Under RAPID, CMS will issue a proposed national coverage determination the same day an eligible device receives FDA authorization, followed by a mandatory 30-day public comment period. The agencies say this could reduce the typical lag between authorization and coverage from roughly a year to as little as two months. The pathway is targeted at medical devices receiving FDA breakthrough designation, with specific eligibility criteria that include device class limits and participation in FDA’s Total Product Life Cycle Advisory Program (TAP) or Investigation Device Exemption studies for Medicare beneficiaries. Biotech and med-tech stakeholders will watch for how quickly coverage decisions translate into reimbursement certainty for next-wave platforms built around faster FDA review tracks.