The FDA and CMS announced the RAPID coverage pathway to cut the time between FDA breakthrough medical device authorization and Medicare national coverage. Under RAPID, CMS will issue a proposed national coverage determination the same day as eligible FDA authorization, triggering a mandatory 30-day comment period. The agencies said RAPID is aimed at devices receiving FDA breakthrough designation, with eligibility covering certain Class II devices that participate in TAP as well as all Class III devices, and requiring an Investigation Device Exemption study enrolling Medicare beneficiaries. CMS suggested the timeline could shrink to about two months from authorization rather than a year or more. The change matters to med-tech manufacturers because coverage delays often become commercial bottlenecks even after regulatory clearance. Developers will now need to align their evidence packages and study design with the RAPID criteria to capture earlier reimbursement certainty.