CMS and the FDA jointly announced RAPID — Regulatory Alignment for Predictable and Immediate Device coverage — on April 23, 2026. RAPID aims to close the gap between FDA authorization and Medicare national coverage from a year or more down to as little as 60-90 days. CMS released a detailed proposed procedural notice (CMS-3487-NC) on August 7, 2026, opening a 60-day comment period (CMS).
How It Works
RAPID syncs FDA's premarket review with CMS's coverage process starting at the Investigational Device Exemption (IDE) pre-submission stage before the pivotal trial is even designed. CMS experts join early to help define which clinical outcomes matter for Medicare beneficiaries. If the IDE study demonstrates the agreed benefit, CMS will post a proposed National Coverage Determination with a 30-day comment period the same day FDA grants authorization. A final NCD will be issued 60 days later for Class II devices and 90 days for Class III.
Who Qualifies
Eligibility is narrow. Devices must enter RAPID at the IDE pre-submission stage. Already authorized devices or those with an IDE study underway are not eligible to participate. To participate, Class II devices need FDA Breakthrough designation plus enrollment in FDA's Total Product Life Cycle Advisory Program (TAP). Class III devices need Breakthrough designation and a planned Premarket Approval pathway with no TAP requirement.
What It Replaces
RAPID replaces the Transitional Coverage for Emerging Technologies (TCET) pathway, which CMS is pausing for new candidates. Where TCET was capped at five devices per year, RAPID targets a substantially larger pool. Currently, an estimated 40 devices qualify with roughly 20 more potentially eligible. Importantly, RAPID does not grant automatic coverage upon FDA authorization. It remains a synchronized NCD process still subject to public comment. For ASGE members, this means novel endoscopic devices such as capsule systems, AI-assisted detection tools tied to a physical device and ablation or closure technologies could see Medicare coverage decisions in as little as 60 to 90 days after FDA authorization, rather than a year or more, provided the device carries Breakthrough designation and enters RAPID at the IDE pre-submission stage.
Public comments are due on October 13, 2026.