Part II: CMS's RAPID Coverage Pathway for Breakthrough Devices: What the August 2026 Procedural Notice Actually Does, Why TCET Got Paused, and Why the First Same-Day NCD Probably Lands After 2030

CMS published the RAPID device coverage pathway on August 11, 2026. The headline: a proposed Medicare coverage decision the same day as FDA authorization. The fine print is more complicated.

Eligibility is tight. Only Breakthrough devices at the pre-submission stage qualify. If your study is already enrolling patients, the door is closed. In vitro diagno…