The FDA and CMS launched the RAPID coverage pathway, a new mechanism intended to reduce the lag between FDA authorization of selected breakthrough medical devices and Medicare national coverage determinations. Under RAPID, eligible devices that receive FDA authorization trigger a proposed national coverage decision immediately, followed by a mandatory 30-day public comment period. CMS said this could enable coverage and payment as early as roughly two months after authorization, compared with timelines that can stretch a year or more. Eligibility is tied to FDA breakthrough designation and participation in specific programs, including TAP and Investigation Device Exemption studies enrolling Medicare beneficiaries to evaluate agreed-upon clinical outcomes. The policy move is designed to compress the regulatory-to-reimbursement timeline—one of the key bottlenecks for device adoption in the U.S. healthcare system.
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