Blog | 2/7/2025
TCET: Paving the Way for Medicare's Future in Innovative Technology
By Jeff Abraham, Partner
The TCET (Transitional Coverage for Emerging Technologies) pathway, recently finalized by CMS, aims to enhance access to innovative medical devices for Medicare beneficiaries while ensuring that adequate evidence is developed to support long-term coverage decisions.
TCET represents a significant shift in how Medicare approaches coverage for emerging technologies in digital health. It offers a transparent process and an accelerated path to approval and access: CMS is clear about the evidence requirements and aims to finalize national coverage determinations (NCDs) within six months of FDA authorization, enabling faster access to potentially life-saving technologies for patients.
While there is warranted optimism regarding its potential to enhance access and streamline processes, concerns about limitations in scope, resource allocation, and evidence quality persist. The data must be collected in a Medicare population and the scope is currently limited to products that already fit into existing benefit categories and further excludes diagnostics – it is ironic that an ‘emerging technologies’ scheme excludes proven emerging technologies such as software as medical devices and digital diagnostic tools.
As the TCET pathway unfolds, its success will depend on how effectively it balances the need for rapid access to innovative technologies with the imperative of rigorous evidence development. While it offers a more efficient route for Medicare beneficiaries to access new medical devices, concerns remain about its restrictive eligibility criteria and the exclusion of key digital health innovations. Moving forward, it will be crucial for stakeholders—including manufacturers, healthcare providers, and policymakers—to engage in ongoing dialogue to address these limitations and advocate for broader inclusion of emerging technologies. Ultimately, the TCET pathway has the potential to reshape Medicare's approach to innovative medical devices, but its impact will hinge on the ability to adapt and respond to the evolving landscape of healthcare technology.
Author
- Jeffrey Abraham, Partner, Co-leads Health Advances’ Health IT and Digital Health practice