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    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

    Uses

    Concepts or artefacts this term builds on.

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    Primary references

    2 sources
    Link health: 2 verified· last checked 2026-06-20
    AMA·1AdvaMed·1
    1. 1
      AMA CPT Resources
      Verified
      AMAama-assn.org
    2. 2
      AdvaMed - Payment & Coverage
      Verified
      AdvaMedadvamed.org

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