The U.S. FDA and Centers for Medicare & Medicaid Services announced a new regulatory alignment pathway, RAPID, designed to shorten the delay between FDA authorization of breakthrough medical devices and Medicare national coverage decisions. The pathway is specifically targeted to devices receiving FDA breakthrough designation. 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. CMS and FDA say this could enable Medicare national coverage and payment as early as two months after authorization, compared with roughly a year or more under current timelines. Eligibility is tied to device class and participation in FDA programs, including TAP (Total Product Life Cycle Advisory Program) for certain Class II devices and Investigation Device Exemption participation for enrolling Medicare beneficiaries. The program is also positioned to manage clinical evidence gathering alongside coverage decisions. For med-tech manufacturers, the key impact is earlier reimbursement certainty and reduced time-to-patient access for breakthrough-designated devices, potentially improving adoption curves after regulatory clearance.