<a href="https://www.fiercehealthcare.com/health-tech/cms-fda-announce-new-program-speed-medicare-coverage-breakthrough-medical-devices" hreflang="en">CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices</a>
The CMS and FDA have launched the RAPID coverage pathway to expedite Medicare coverage for breakthrough medical devices, aiming to reduce delays between FDA approval and Medicare reimbursement. This program enhances collaboration between the two agencies and allows for quicker access to innovative therapies for Medicare beneficiaries.
The CMS and FDA have introduced the RAPID coverage pathway, which significantly speeds up Medicare coverage for FDA-designated Class II and III breakthrough devices by aligning evidentiary expectations early in the development process. This program allows for Medicare coverage within 60 to 90 days of FDA approval, offering a strategic advantage for device manufacturers aiming to expedite market entry and reimbursement processes. This development is crucial for stakeholders in the medtech industry looking to capitalize on reduced timeframes between FDA authorization and Medicare coverage decisions.