July 13, 2023

ACR Provides Detailed Summary of the 2023 TCET Pathway and Coverage With Evidence Development Proposed Criteria

The American College of Radiology® (ACR®) released a detailed summary  of the Centers for Medicare and Medicaid Services (CMS) 2023 Transitional Coverage of Emerging Technologies (TCET) that also includes proposed changes to the Coverage with Evidence Development as previously reported.

The summary provides details about current Medicare coverage mechanisms, the U.S. Food and Drug Administration (FDA) Breakthrough Devices program, the TCET pathway with timelines for evidence generation, and its connection with the National Coverage Determination (NCD) process. It also outlines the roles and responsibilities of stakeholders and federal agency partners that seek Medicare coverage through this new pathway.

CMS believes that the TCET pathway can support manufacturers that are interested in working with CMS to generate additional evidence that is appropriate for Medicare beneficiaries and that may demonstrate improved health outcomes in the Medicare population to support more expeditious national Medicare coverage. CMS is seeking feedback from specialty societies and patient advocacy organization experts that have input for recommended conditions of coverage for these emerging technologies.

The ACR will likely submit comments to CMS regarding these proposed concepts. If you have questions or an interest in this topic, contact Alicia Blakey, ACR Principal Economic Policy Analyst.