The Centers for Medicare & Medicaid Services (CMS) has officially launched the Transitional Coverage for Emerging Technologies (TCET) pathway, aiming to accelerate Medicare coverage for innovative medical devices designated as Breakthrough Devices by the FDA. This initiative, finalized on August 12, 2024, seeks to bridge the gap between FDA approval and Medicare coverage, ensuring timely access to potentially life-improving technologies for beneficiaries.
Objectives of the TCET Pathway
The TCET pathway is designed to provide a structured approach for evaluating and covering emerging technologies that hold promise but require further evidence to meet the standard “reasonable and necessary” criteria for Medicare coverage. CMS intends for the TCET pathway to benefit both manufacturers and Medicare beneficiaries. For manufacturers, TCET aims to offer a more efficient and transparent Medicare coverage review process that allows for enhanced communications between industry and CMS, clear evidence requirements, and defined timelines for final coverage actions. For Medicare beneficiaries, TCET offers access to the latest medical innovations while ensuring these new technologies are appropriate and beneficial to the Medicare population based on data and available evidence.
Eligibility Criteria
To be eligible for the TCET pathway, devices must meet several criteria:
- Be designated by the FDA as a Breakthrough Device.
- Fall within a recognized Medicare benefit category.
- Not be subject to an existing National Coverage Determination (NCD).
- Not be excluded from coverage by law or regulation.
While in vitro diagnostic (IVD) products are not categorically excluded, CMS intends to prioritize non-IVD devices, suggesting that IVD manufacturers should primarily pursue coverage through Medicare Administrative Contractors or the traditional NCD request process.
TCET Pathway Procedures
The TCET pathway consists of three main stages:
- Pre-market: This stage involves non-binding letters of intent from manufacturers, TCET pathway nominations, CMS review of nominations, evidence previews, and evidence development plans.
- Coverage under the TCET pathway: Following FDA market authorization, CMS initiates the NCD process, contingent on an approved evidence development plan (EDP) where evidence gaps exist. The duration of coverage is tied to the EDP, typically lasting five or more years.
- Transition to post-TCET coverage: CMS initiates an updated evidence review within six months of the EDP review date. Based on this review, CMS may issue an NCD without evidence development requirements, an NCD with continued evidence development requirements, a non-coverage NCD, or allow local MACs to make coverage decisions.
Evidence Development and Review
Central to the TCET pathway is the emphasis on evidence development. If evidence gaps are identified during the Evidence Preview (EP), manufacturers must submit an Evidence Development Plan (EDP) to CMS. CMS aims to finalize the EDP within 90 business days after FDA market authorization. Transitional coverage duration is linked to the approved EDP, facilitating the generation of evidence to inform patient and clinician decision-making.
Implications and Next Steps
CMS plans to review TCET pathway nominations quarterly, aiming to accept up to five candidates per year. The agency intends to release proposed factors that will be used to prioritize TCET nominations in the near future. Until such factors are published, CMS will prioritize TCET candidates based on the magnitude of the potential impact on the Medicare program and its beneficiaries and staffing resources. Nominations for the initial quarterly review are due by October 31, 2024, with subsequent deadlines on January 31, 2025, April 30, 2025, and July 31, 2025.
