The FDA and CMS announced the RAPID coverage pathway to align regulatory review with Medicare coverage decisions for FDA-designated breakthrough medical devices. The program is designed to reduce delays between market authorization and national coverage determinations, targeting an earlier on-ramp to reimbursement. 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 project Medicare national coverage and payment could occur as early as two months after authorization, compared with about a year or more under current steps. RAPID is available for certain Class II devices that participate in FDA’s Total Product Life Cycle Advisory Program (TAP), and for all Class III devices regardless of TAP participation. Eligible devices must also be part of an Investigation Device Exemption study enrolling Medicare beneficiaries. For device makers and translational health technology teams, the policy change targets one of the industry’s most persistent commercialization bottlenecks—coverage timing—by tightly coupling evidence generation and payment decisions earlier in the approval-to-coverage timeline.