CMS Proposes RAPID Pathway for Breakthrough Devices; Comments Due Oct. 13

CMS published an NCD notice with comment (91 Fed. Reg. 51710, Aug. 11, 2026) proposing RAPID, a voluntary pathway that would coordinate FDA and CMS at IDE pre-submission so that clinical outcomes serve both marketing authorization and Medicare coverage review. Comments are due October 13, 2026.

Eligibility is narrow: presumptive Class II breakthrough devices in FDA's TAP program planning a de novo request, or Class III breakthrough devices planning a PMA, each still at the IDE pre-submission stage. Devices already covered by a controlling NCD, not separately payable, excluded by law, or in vitro diagnostics would be ineligible; CMS says IVD coverage determinations should continue through existing contractor pathways. CMS also proposes pausing TCET for new candidates and prioritizing RAPID NCDs over the NCD Wait List.

For medtech counsel and device clients, the trade-off is concrete: a possible final NCD within 60 days (Class II) or 90 days (Class III) of FDA authorization, against materially earlier and costlier dual-agency engagement, possible Coverage with Evidence Development conditions where evidence is thin, and voluntary exit only before a proposed NCD issues. Key next steps are the comment docket, whether CMS adopts a temporary route for devices already past IDE pre-submission, and any knock-on effect on wait-list timing for non-RAPID devices.