The TCET program is focused on (1) facilitating early, predictable, and safer beneficiary access to new technologies; (2) reducing uncertainty about coverage by evaluating early the potential benefits and harms of technologies with manufacturers; and (3) encouraging evidence development if notable evidence gaps exist for coverage purposes. Just as stated in the proposed notice last year, CMS is limiting TCET candidates to just five per year.

TCET also includes a mechanism to coordinate benefit category, coding, and payment reviews, encourages evidence development if notable evidence gaps exist for coverage purposes, and incorporates patient safeguards intended to ensure that devices are clinically appropriate for the Medicare patient population. Pending legislation may enable faster coverage and for more than just five per year called Ensuring Patient Access to Critical Breakthrough Products Act. It is bipartisan with 87 co-sponsors and passed the House Ways and Means Committee in June 2024. If enacted, it would provide four years of Medicare coverage to any device designated as a Breakthrough Device by the FDA. The main differences between the proposed and final CMS rulemaking include:

• Manufacturers can submit a non-binding letter of intent to nominate 18-24 months before the anticipated FDA decision date despite the notice focusing on self-nominating within 12 months prior to anticipated FDA market authorization.
• 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 convene a Medicare Evidence Development & Coverage Advisory Committee panel – a non-binding letter of intent from the manufacturer may avoid delays in TCET reviews.
• Each quarter, CMS will review nominations and if a manufacturer is not accepted in the first review, its application will automatically be considered in the next cycle. This means applicants submitting approximately 12 months prior to the anticipated FDA marketing authorization date will have two chances to be accepted into TCET before becoming ineligible.
• If a National Coverage Decision (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.
• CMS will post the evidentiary summary publicly even if the applicant withdraws from TCET, but the summary will exclude an evidence gap analysis, and CMS will not share the full EP and gap analysis with the MACs as was proposed.
• CMS said it will release its proposed factors for prioritizing TCET nominations in the near future and noted until these factors are published, the agency intends to prioritize medical devices that have the potential to benefit the greatest number of Medicare beneficiaries.

See our TCET webinar from August 23rd, 2023 here.