--- title: "TCET Definition & Meaning | MedTech Terms" description: "CMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Reimbursement](/terms?cat=Reimbursement) 6. / 7. Transitional Coverage for Emerging Technologies [All terms](/terms) Reimbursement [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)[Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)TCET # Transitional Coverage for Emerging Technologies CMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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 What types of devices are eligible for TCET? TCET is primarily designed for devices that have received an FDA [Breakthrough Device designation](/terms/breakthrough-device) and meet specific CMS criteria for coverage. How does TCET differ from the previous MCIT rule? What is the role of an evidence development plan in TCET? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ Breakthrough Device Designation(BDD) ](/terms/breakthrough-device) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Reimbursement National and Local Coverage Determinations(NCD / LCD) Medicare coverage policies issued nationally (NCD) or by individual MAC contractors (LCD). ](/terms/ncd-lcd)[ Reimbursement Coverage with Evidence Development(CED) Medicare paradigm conditioning coverage on participation in approved clinical studies or registries. ](/terms/ced)[ Regulatory Breakthrough Device Designation(BDD) FDA program providing expedited review for devices that treat life-threatening or irreversibly debilitating conditions. ](/terms/breakthrough-device) ### Reimbursement & Market Access · From this learning path [ Reimbursement New Technology Add-On Payment(NTAP) Supplemental Medicare payment for inpatient use of qualifying new technologies. Adjacent lesson ](/terms/ntap?from=reimbursement-and-market-access)[ Reimbursement Prior Authorization Payer requirement for approval before a service or device is covered. Adjacent lesson ](/terms/prior-authorization?from=reimbursement-and-market-access)[ 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. ](/terms/budget-impact-model?from=reimbursement-and-market-access)[ Reimbursement CPT Codes(CPT) AMA-maintained codes that describe medical procedures and services. ](/terms/cpt-codes?from=reimbursement-and-market-access) ### More in Reimbursement · Same category [ Reimbursement Current Procedural Terminology Codes(CPT) AMA-maintained codes used to report medical procedures and services for billing. ](/terms/cpt) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Reimbursement & Market Access](/paths/reimbursement-and-market-access)Lesson 9 of 14 Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) - [Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer) ## Primary references 2 sources Link health: 2 verified · last checked 2026-06-20 AMA· 1 AdvaMed· 1 1. [1 AMA CPT Resources Verified AMA · ama-assn.org ](https://www.ama-assn.org/practice-management/cpt) 2. [2 AdvaMed - Payment & Coverage Verified AdvaMed · advamed.org ](https://www.advamed.org/our-work/) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Need cybersecurity expertise on a connected-device launch? Blue Goat Cyber helps MedTech teams ship connected products that hospital security teams will actually procure. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Reimbursement Acronym TCET Sources 2 Updated 5/5/2026 [Compare with another term](/compare?a=tcet) Learn in 60 seconds Card Lesson Quiz CMS pathway providing time-limited Medicare coverage for FDA-designated Breakthrough Devices. - · TCET replaced the unimplemented MCIT rule and is intended to shrink the gap between FDA market authorization and Medicare coverage for high-impact devices. Remember this Watch out: A common mistake is assuming TCET guarantees permanent Medicare coverage; it provides time-limited coverage tied to evidence development. Related terms - [Breakthrough Device Designation(BDD) ](/terms/breakthrough-device) - [National and Local Coverage Determinations(NCD / LCD) ](/terms/ncd-lcd) - [Coverage with Evidence Development(CED) ](/terms/ced) You may also need Auto-suggested from Reimbursement and shared keywords. - [LCD and NCD ](/terms/lcd-ncd) - [Health Technology Assessment(HTA) ](/terms/hta) - [RWE for Reimbursement ](/terms/real-world-evidence-reimbursement) - [Transitional Pass-Through Payment(TPT) ](/terms/tpt) - [Current Procedural Terminology Codes(CPT) ](/terms/cpt) - [Budget Impact Model(BIM) ](/terms/budget-impact-model) [All Reimbursement terms](/terms?cat=Reimbursement) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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