The FDA and CMS announced a new RAPID coverage pathway intended to reduce the time between FDA authorization and Medicare coverage decisions for breakthrough medical devices. Under RAPID, eligible devices receive proposed national coverage determinations the same day as FDA authorization, followed by a mandatory 30-day public comment period. The agencies estimate Medicare national coverage and payment could occur as early as two months after authorization for qualifying devices, versus up to a year or more under the current pathway. The policy is limited to devices with FDA breakthrough designation and participation in specified programs, including the Total Product Life Cycle Advisory Program. For device innovators and diagnostics-adjacent developers, the alignment framework shifts a key market-access variable by shortening payer decision timelines, potentially compressing the commercial ramp after regulatory clearance.