The Transitional Coverage for Emerging Technologies Pathway: A Balance Between Innovation and Patient Safety

The Centers for Medicare & Medicaid Services (CMS) have launched a new initiative aimed at providing Medicare patients with better access to emerging technologies. The Transitional Coverage for Emerging Technologies (TCET) pathway, announced on June 22, 2023, aims to promote faster access to new technologies while implementing transparent, predictable, and efficient coverage review processes.

The TCET pathway is part of a broader coverage modernization initiative that focuses on certain US Food and Drug Administration (FDA) devices designated by the Breakthrough Devices Program. This program aims to accelerate the development of new medical devices for patients with life-threatening or irreversibly debilitating diseases or conditions.

The TCET pathway aims to support coverage for promising new technologies as manufacturers develop additional evidence after the devices enter the market. It also includes safeguards that protect Medicare beneficiaries while promoting high-quality care. This was developed with extensive stakeholder feedback, with stakeholders expressing support for a more transparent, predictable, and collaborative coverage pathway. To reduce potential risks associated with new technologies, TCET includes safeguards that ensure emerging technologies are provided to clinically appropriate patients.

This pathway represents a significant advancement in CMS’s approach to Coverage With Evidence Development (CED). CMS agrees with stakeholder feedback that CED requirements should not be open-ended and will commit to reviewing the available evidence again after an approved Evidence Development Plan is completed.

In conclusion, CMS remains committed to modernising its coverage pathways to deliver efficient, predictable, and transparent coverage of emerging medical technologies. The TCET pathway aims to accelerate national coverage where the evidence supports it but may offer transitional coverage for technologies that do not yet satisfy the reasonable and necessary standard when they first enter the market.