Reimbursement
Transitional Coverage for Emerging Technologies(TCET)
In one line
CMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices.
Definition
TCET is a voluntary pathway providing predictable, time-limited national Medicare coverage for selected Breakthrough Devices, paired with an evidence development plan to inform a longer-term coverage determination.
CMS finalized TCET in August 2024. Manufacturers of FDA-designated Breakthrough Devices in eligible Medicare benefit categories can nominate their device, and CMS accepts a limited number per year. CMS aims to finalize an NCD within six months of FDA authorization, and coverage is reviewed again once the agreed evidence gaps are filled.
Why it matters
TCET replaced the unimplemented MCIT rule and is intended to shrink the gap between FDA market authorization and Medicare coverage for high-impact devices.
Common pitfalls
- •A common mistake is assuming TCET guarantees permanent Medicare coverage; it provides time-limited coverage tied to evidence development.
- •Failing to adhere to the evidence development plan specified under TCET can jeopardize continued coverage.
- •Misinterpreting the "breakthrough device" designation as an automatic qualifier for TCET without meeting additional CMS criteria is a pitfall.
Sources