Transitional Coverage for Emerging Technologies
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.What this means in practice
TCET replaced the unimplemented MCIT rule and is intended to shrink the gap between FDA market authorization and Medicare coverage for high-impact devices.Examples
- A manufacturer of an FDA-authorized Breakthrough Device for early cancer detection applies for TCET to gain Medicare coverage during the post-market study phase.
- A company with an innovative cardiovascular device utilizes TCET to gather real-world evidence on patient outcomes while their device is accessible to Medicare beneficiaries.
- A MedTech firm uses the TCET pathway to ensure Medicare patients have access to their novel neurological implant while long-term effectiveness data is being collected and analyzed.
- •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.
Frequently asked questions
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsMedicare coverage policies issued nationally (NCD) or by individual MAC contractors (LCD).
Medicare paradigm conditioning coverage on participation in approved clinical studies or registries.
FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
Reimbursement & Market Access
· From this learning pathSupplemental Medicare payment for inpatient use of qualifying new technologies.
Payer requirement for approval before a service or device is covered.
Financial model that estimates the total cost consequences of adopting a new technology to a payer's budget over a defined horizon.
AMA-maintained codes that describe medical procedures and services.
More in Reimbursement
· Same categoryWhere this term appears across MedTech Terms.
- Reimbursement & Market AccessLesson 9 of 14
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Sources
2 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
Official citation replacements checked: . Medicare documents support Medicare coding, coverage or payment context, not every payer policy or CPT editorial procedure. Citation replacement does not change the full term review date.
- 1Medicare Program; Transitional Coverage for Emerging Technologies (Final Notice)Tier 1 VerifiedFederal Register / CMSfederalregister.gov
- 2TCET final notice: pathway and coverage processTier 2 UncheckedCMScms.gov
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