CMS Education Session on Transitional Coverage for Emerging Technologies (TCET) Pathway

Among other topics, the session covered data collection requirements, and the steps manufacturers may take to gain expedited coverage for their devices by demonstrating that a device is “reasonable and necessary,” as well as suitable, safe, and effective for Medicare beneficiaries.

HRS submitted comments to CMS last year when this pathway was first proposed. Although medical device groups strongly support an alternative, expedited pathway to coverage and payment for emerging devices and diagnostics, they have some ongoing concerns about the finalized TCET pathway, including: its limited scope, which only allows participation of up to five devices per year, and the complex evidence requirements that could delay market access to breakthrough devices. The CMS session aimed to address these concerns while providing transparency and guidance on how TCET differs from the previously repealed Medicare Coverage of Innovative Technology (MCIT) program.

In August 2024, CMS published a final notice outlining the procedures for the TCET pathway. The pathway intends to expedite Medicare coverage for FDA-designated breakthrough devices; mainly, by leveraging existing frameworks like the national coverage determination (NCD) and coverage with evidence development (CED). Per the final notice, manufacturers are encouraged to submit non-binding letters of intent for breakthrough devices to CMS approximately 18 to 24 months before expected FDA market authorization. While not required, the letter of intent allows CMS to provide manufacturers with advance guidance on the type of data needed for the approval of their devices. Full device nominations must then be submitted approximately 12 months prior to FDA market authorization—at which point, manufacturers can begin discussions with CMS on any gaps in evidence. Approved devices with sufficient evidentiary support will be expedited through the NCD process.

Device nominations submitted by October 31, 2024, will be considered in the first quarterly review cycle. CMS intends to hold another workshop in the near future to assist manufacturers that are considering submitting letters of intent and device nominations.

Additional information about the TCET pathway can be found at CMS fact sheet and CMS article