The Centers for Medicare & Medicaid Services (CMS) recently announced the Transitional Coverage for Emerging Technologies (TCET) pathway. This program aims to provide Medicare coverage and reimbursement for medical devices designated as Breakthrough Devices by the Food and Drug Administration (FDA). However, the TCET pathway has some limitations that have disappointed industry stakeholders.
CMS plans to accept only up to five technologies per year as TCET candidates. The method for prioritizing nominated devices remains unspecified, and CMS will make acceptance decisions quarterly. TCET applicants must submit formal nominations approximately 12 months prior to an FDA marketing authorization decision.
Devices expected to receive FDA authorization within six months are less likely to be accepted. The devices must also fall within an existing Medicare benefit category to apply, which excludes many digital health technologies. CMS’s goal is to finalize a TCET National Coverage Determination (NCD) within six months after a candidate receives FDA marketing authorization.
Emerging tech faces coverage challenges
However, the timeline could be longer, imposing a potentially significant gap for device manufacturers. In response to the limitations of the TCET pathway, U.S. House Representatives Brad Wenstrup (R-Ohio) and Suzan DelBene (D-Wash.) re-introduced the bi-partisan Ensuring Patient Access to Critical Breakthrough Products Act (H.R. 1691) in March 2023.
This bill aims to authorize Medicare coverage over a four-year period for medical devices designated as Breakthrough Devices and authorized for marketing by the FDA. H.R. 1691 goes beyond CMS’s final notice for the TCET pathway by streamlining the process to ensure patients can access innovative medical devices without unnecessary delays. The bill also requires CMS to assign payment codes for devices within three months of FDA approval.
The Ensuring Access to Critical Breakthrough Products Act has gained significant bipartisan support, with 87 House co-sponsors. However, given the constraints of the election year calendar, there is limited opportunity to bring the bill up for consideration on the House floor. Industry stakeholders have redoubled their advocacy in support of the bill since the TCET final notice.
ML Strategies is working on behalf of several clients to advance the bill and can advise interested parties on the legislation’s prospects.
- JDSupra.”CMS Issues Final Notice on Program for Breakthrough Device Reimbursement but Industry Looks to Congress for More Inclusive Solution”.
- RadiologyBusiness.”CMS expands coverage pathway for emerging technologies, drawing imaging industry criticism”.
- PRNewswire.”Alliance for Aging Research Statement on Restrictive Medicare Coverage Policies that Mandate Clinical Study Participation for FDA-Approved Medical Treatments”.