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 diagnostics are excluded entirely.
Coverage is not payment. An NCD says Medicare covers something. It says nothing about the billing code, the payment rate, or the care setting. Those run on separate calendars RAPID does not touch.
Do the timeline math: enter RAPID in late 2026, run a study, get authorized, wait on coding. The first device with both coverage and a workable payment rate is probably a 2031 or 2032 event.
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