All terms
Transitional Coverage for Emerging Technologies
CMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
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. What the regulation says
The Centers for Medicare & Medicaid Services (CMS) established the Transitional Coverage for Emerging Technologies (TCET) pathway to provide a streamlined and predictable path to Medicare coverage for certain medical devices. This initiative aims to bridge the gap between U.S. Food and Drug Administration (FDA) market authorization and Medicare coverage determinations, particularly for devices designated as Breakthrough Devices by the FDA.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.
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.
Frequently asked questions
TCET is primarily designed for devices that have received an FDA Breakthrough Device designation and meet specific CMS criteria for coverage.
Cross-references
Related terms
Shared paths + categoryReimbursement
National and Local Coverage Determinations(NCD / LCD)
Medicare coverage policies issued nationally (NCD) or by individual MAC contractors (LCD).
Reimbursement & Market Access
Reimbursement
Coverage with Evidence Development(CED)
Medicare paradigm conditioning coverage on participation in approved clinical studies or registries.
Same category
Regulatory
Breakthrough Device Designation(BDD)
FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions.
Reimbursement
New Technology Add-On Payment(NTAP)
Supplemental Medicare payment for inpatient use of qualifying new technologies.
Reimbursement & Market Access · adjacent
Reimbursement
Prior Authorization
Payer requirement for approval before a service or device is covered.
Reimbursement & Market Access · adjacent
Reimbursement
Budget Impact Model(BIM)
Financial model that estimates the total cost consequences of adopting a new technology to a payer's budget over a defined horizon.
Reimbursement & Market Access
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Primary references
2 sourcesLink health: 2 verified· last checked 2026-06-20
AMA·1AdvaMed·1
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