A proposed CMS pathway could get breakthrough devices Medicare coverage within 60 to 90 days of FDA authorization. However, the American Society for Gastrointestinal Endoscopy and the American College of Gastroenterology say gaps remain for gastrointestinal technology, according to recent blog posts.
Here are seven things to know:
1. CMS and the FDA announced the Regulatory Alignment for Predictable and Immediate Device coverage pathway, known as RAPID, in April 2026. A proposed national coverage determination would be issued the same day a device receives FDA market authorization. A 30-day comment period would follow, and the final NCD would come about 60 days after authorization for Class II devices and 90 days for Class III. The traditional NCD process generally takes nine to 12 months.
2. CMS paused the Transitional Coverage for Emerging Technologies pathway for new candidates in April 2026. That pathway had been finalized in August 2024.
3. Devices must have FDA Breakthrough designation, address an unmet need among Medicare patients and be studied in an Investigational Device Exemption trial that enrolls Medicare patients. Class III devices qualify directly. Class II devices must also be in the FDA’s Total Product Life Cycle Advisory Program, known as TAP, which has 159 devices in its pilot and a target of 325 for fiscal 2027.
4. CMS would review the manufacturer’s IDE plan before the study launches, and the FDA would share the final IDE report to inform the coverage decision. ACG calls the early review a new feature of the process and critical to speeding up coverage.
5. CMS generally doesn’t intend RAPID to cover devices already past the IDE pre-submission stage, but it has asked for comment on a transition process. TAP rolled out to FDA divisions in stages and reached the division that reviews GI devices on May 1, 2026. That leaves what ASGE calls a “donut hole” for devices that entered pivotal trials earlier. ASGE is asking CMS to admit devices that have Breakthrough designation, started their IDE or pivotal program before TAP was available, are still premarket when the final RAPID notice takes effect, and whose manufacturers agree to CMS evidence review.
6. Depending on the evidence and a device’s risk, a RAPID NCD could grant conventional coverage or require coverage with evidence development, which ties payment to ongoing data collection. ACG also warns that prioritizing RAPID could delay CMS decisions on other devices waiting for NCDs.
7. Breakthrough devices can currently qualify for new technology add-on payments without showing substantial clinical improvement. CMS is phasing out that alternative pathway in 2028, according to ACG, so devices could gain faster coverage but lose an easier route to add-on payments. The FDA had granted 1,284 Breakthrough Device designations as of March 31, 2026, including 119 assigned to its Gastroenterology & Urology Clinical Panel.
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