The Medicare pathway built two years ago to speed coverage of breakthrough devices is being paused for new applicants, and the replacement filed on Friday admits far fewer devices
Two years, less a day.
That is the gap between 12 August 2024, when the Centers for Medicare & Medicaid Services published the final notice establishing the Transitional Coverage for Emerging Technologies pathway, and Tuesday, when a notice filed at 4.15 on Friday afternoon closes it to new candidates. In its place CMS proposes the Regulatory Alignment for Predictable and Immediate Device coverage pathway, announced in April and now out for comment. Both were built to solve the same problem, which is the lag between the day the Food and Drug Administration authorises a device and the day Medicare decides whether it will pay for it.
The offer
Under the new pathway, if a study shows the device improves health outcomes in the Medicare population, CMS posts a proposed national coverage determination on the day of FDA market authorisation. Final determination follows as soon as 60 days later for a Class II device, 90 for a Class III.
CMS says manufacturers told it that a short gap of 60 to 90 days is useful rather than unwelcome, because it gives them time to prepare distribution.
The gate
Eligibility is where the two pathways part company, and it is narrow. A device must hold FDA breakthrough designation. A Class II device must additionally be enrolled in the FDA's Total Product Life Cycle Advisory Program and be planning a De Novo request. A Class III device must be planning a premarket approval application, in that programme or not.
Then the timing condition. The device must be at the presubmission stage of its investigational device exemption, and the study must enrol Medicare beneficiaries and measure clinical health outcomes that the two agencies have agreed on in advance. Manufacturers who are already past that point are told, in the document, to contact CMS about other mechanisms.
Two things worth reading twice
CMS proposes to publish the names. The identity of specific manufacturers and devices in the pathway would be made public, with the agency's approved study page and its coverage dashboard given as the examples of where.
And the pathway takes priority. If CMS cannot handle the total volume of coverage determinations within its resources, it proposes to open pathway determinations ahead of everything else on the wait list. The notice states that there are already topics on that list.
The status
This is a notice with comment period, not a rule. Comments run 60 days from publication and go to docket CMS-2026-2674. Parallel Review, the older and broader route, stays open.
Administrator Mehmet Oz approved the document on Thursday. The Secretary of Health and Human Services, Robert F. Kennedy, Jr., signed it.
