The FDA and CMS announced a new RAPID coverage pathway designed to reduce the lag between FDA authorization of breakthrough devices and Medicare national coverage decisions. Under the approach, CMS will issue a proposed national coverage determination the same day a qualifying device receives FDA authorization, followed by a 30-day mandatory public comment period. The agencies said RAPID is intended for devices participating in the FDA’s Total Product Life Cycle Advisory Program (TAP) and certain Class II or Class III products, and it also requires enrollment in an Investigation Device Exemption study with agreed clinical outcomes. If implemented as planned, the pathway could shorten the timeline to Medicare coverage to as little as two months, versus about a year or more under the current sequence—an execution shift with immediate implications for med-tech developers targeting reimbursement read-through.