On August 7, the Centers for Medicare & Medicaid Services (CMS) issued a final notice on the Transitional Coverage for Emerging Technologies (TCET) Pathway to expedite national coverage of some FDA-designated breakthrough devices. In August 2023, the CAP offered several recommendations on the proposed TCET pathway. The final notice implemented these recommendations from the CAP:

• Ensure diagnostic tests are included in the TCET pathway. In the final notice, the CMS decided laboratory diagnostic tests will continue to be made by Medicare Administrative Contractors (MAC) through existing local coverage pathways.
• Increased transparency of unspecified criteria used by the CMS to prioritize innovative technologies and transparency of pathway timelines. The CMS agreed to provide this information on a public dashboard that will be updated regularly including quarterly (instead of annual) reviews of the TCET nominations, pre-emptive endpoint reviews, and convening MEDCAC panels to examine the data that has been collected.
• Ensure the protection of a developer or manufacturer’s proprietary information about a device that it has developed if a manufacturer withdraws from the process during the premarket stage. CMS said it will not divulge the identity of specific manufacturers or devices in the TCET pathway prior to the opening of an NCD. However, the CMS said it is important to provide transparency on devices that are accepted into the pathway.

The pathway uses existing national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage for devices where the evidence is promising but does not yet satisfy the reasonable and necessary standard for Medicare coverage. A breakthrough device is defined as a novel medical device that has the potential to provide more effective treatment or diagnosis, and meets the criteria outlined under the 21st Century Cures Act. On average, it takes approximately five years after a device is authorized by the FDA to receive national Medicare coverage, while TCET coverage may be provided within six months of FDA authorization.

Manufacturers interested in the TCET pathway need to notify the CMS of their interest in TCET and may self-nominate to participle in the pathway. The CMS will soon release the proposed factors it will use to prioritize TCET nominations. The public will have an opportunity to provide comments on the CMS’ proposed prioritization factors. In the meantime, the CMS will prioritize TCET candidates based on the magnitude of the potential impact on the Medicare program and its beneficiaries and staffing resources.