CMS issued proposed details for the RAPID pathway, an effort to reduce the gap between FDA breakthrough device approvals and Medicare coverage. The program is designed to address “coverage purgatory,” where device sponsors can wait years for reimbursement coverage despite regulatory clearance. The proposed notice outlines how CMS would create more predictable and immediate coverage alignment for eligible breakthrough devices, signaling incremental progress toward CMS’s alternative to the Transitional Coverage for Emerging Technologies (TCET) pathway. Industry reaction in the report was largely positive given the reimbursement uncertainty many device companies face. For diagnostics and medtech developers, the policy shift is relevant because reimbursement timing directly affects trial-to-adoption trajectories and hospital procurement decisions, especially for high-cost or novel technologies.
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