The Centers for Medicare & Medicaid Services (CMS) issued the final procedural notice on Transitional Coverage for Emerging Technologies (TCET), effective as of August 12, 2024. TCET is a new pathway that uses existing national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain breakthrough devices. CMS decided to establish TCET through a procedural notice leveraging existing coverage structures, rather than rulemaking establishing a novel structure, to create what CMS considers to be a faster, more easily modifiable pathway.

Under this finalized pathway, eligible US Food and Drug Administration (FDA) designated breakthrough devices that fall within a Medicare benefit category can obtain national coverage for several years (and perhaps upwards of five years) as the manufacturer develops evidence to address gaps identified through a contractor-generated evidence preview and pursuant to an evidence development plan (EDP).

TCET is the successor to the Medicare Coverage of Innovative Technology (MCIT) pathway that the Trump Administration finalized in January 2021 and which the Biden Administration repealed in November 2021.

KEY DIFFERENCES BETWEEN THE PROPOSED AND FINAL PROCEDURAL NOTICE FOR TCET

Overall, the main framework for the TCET pathway remained constant between the proposed and final notice. However, a few key changes to highlight include the following:

1. While the notice focused on self-nominating no later than 12 months prior to anticipated FDA market authorization, manufacturers have the opportunity to submit a non-binding letter of intent to nominate 18 to 24 months before the anticipated FDA decision date.
2. If CMS is aware that a manufacturer will likely pursue the TCET pathway for a device where appropriate clinical endpoints are uncertain, CMS may preemptively conduct a clinical endpoints review and may convene a Medicare Evidence Development & Coverage Advisory Committee panel. Early submission of a non-binding letter of intent may avoid delays in TCET reviews.
3. CMS will review nominations on a quarterly basis. If a manufacturer is not accepted in the first review, its application will automatically be considered in the subsequent cycle. Applicants submitting approximately 12 months prior to anticipated FDA marketing authorization therefore will essentially have two chances to be accepted into TCET before becoming ineligible.
4. If an NCD is opened, a summary of the evidence captured as part of the evidence preview will be posted with the tracking sheet on the CMS website for public comment.
5. CMS stated its intent to post the evidentiary summary publicly even if the applicant withdraws from TCET. However, this summary will not include an evidence gap analysis, and CMS will not share the full EP including gap analysis with the MACs as proposed.
6. CMS discussed at a high level how it will prioritize applications for TCET, given the limited resources and capacity. CMS stated that it will release its proposed factors for prioritizing TCET nominations in the near future. CMS noted that until these factors are published, the agency intends to prioritize medical devices that have the potential to benefit the greatest number of Medicare beneficiaries.

Michael W. Ryan, partner at McDermott Will & Emery, also contributed to this +Insight. 

RESOURCES

Along with the final procedural notice for TCET, CMS published a blog post and a fact sheet. CMS also issued finalized versions of the following guidance documents:

• Guidance on Coverage with Evidence Development.
• CMS National Coverage Analysis Evidence Review guidance on fit-for-purpose study designs.
• Clinical Endpoints Guidance: Knee Osteoarthritis. This document is the first in a series of clinical endpoints guidance documents that review health outcomes and their clinically meaningful differences within priority therapeutic areas.