John A McInnes

In August 2024, the Centers for Medicare & Medicaid Services (CMS) established the Transitional Coverage for Emerging Technologies (TCET) pathway, intended to "accelerate patient access to beneficial medical products while generating evidence" needed to assess long-term coverage.1 This pathway is limited to certain devices that have been designed as Breakthrough devices by the Food and Drug Administration (FDA), and CMS expects that it will be able to accommodate only five devices a year.

In August 2024, the Centers for Medicare & Medicaid Services (CMS) established the Transitional Coverage for Emerging Technologies (TCET) pathway, intended to “accelerate patient access to beneficial medical products while generating evidence” needed to assess long-term coverage.1 This pathway is limited to certain devices that have been designed as Breakthrough devices by the Food and Drug Administration (FDA), and CMS expects that it will be able to accommodate only five devices a year.

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a long-awaited procedural notice with comment period (CMS-3421-NC)1 that outlines a proposed Transitional Coverage for Emerging Technologies (TCET) pathway for certain Breakthrough Devices that would build off the Medicare national coverage determination (NCD) process and Coverage with Evidence Development (CED).