CBSA advocates for policies that improve patient access to life-saving, novel technologies. This August, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Transitional Coverage for Emerging Technologies (TCET) Pathway Final Notice. Although this rule is a step in the right direction, CBSA continues to urge Congress to pass the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) to more fully address seniors’ need for access to breakthrough diagnostics and treatments soon after they are approved by the Food & Drug Administration (FDA). 

The New TCET Pathway

In January 2021, CMS announced the Medicare Coverage of Innovative Technology (MCIT) rule, which would have provided four years of automatic coverage for FDA-approved breakthrough-designated products. CMS repealed the MCIT rule that November, a month before it was set to go into effect. At the repeal of MCIT, CMS announced it would propose a new rule called Transitional Coverage for Emerging Technologies (TCET). In June of 2023, CMS released its notice on the long-anticipated proposed TCET pathway. 

Additional background information and details about CBSA’s advocacy on this issue can be found in past CBSA policy blogs: CBSA Advocates for Medicare Coverage of Emerging Technologies and CBSA and Partners Provide Recommendations to Improve CMS’ Transitional Coverage for Emerging Technologies (TCET) Proposal. 

While the final TCET pathway released by CMS this August includes some small procedural changes “to achieve more timely and predictable access to certain new medical technologies,” the new TCET pathway is still limited to certain FDA-designated Breakthrough Devices and CMS only anticipates accepting up to five TCET candidates per year, citing resource constraints. AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker on CMS’ final TCET notice: 

“The final TCET notice is a step toward a stronger, more robust policy, but doesn’t go far enough to help the Medicare seniors depending on breakthrough diagnostics and treatments to alleviate their suffering. The limited number of devices CMS can handle demonstrates clearly to Congress the need for greater resources at CMS. And the exclusion of diagnostics is disappointing, particularly considering the potential for a breakthrough diagnostic technology to save not only lives but costs to the health care system overall through earlier detection. While we appreciate that CMS has released the rule, we call on Congress to finish the job by passing HR 1691, the Ensuring Access to Critical Breakthrough Products Act. Too many patients in need of breakthrough diagnoses and treatments are counting on it.” 

Manufacturers interested in the TCET pathway need to notify CMS of their interest in TCET electronically via the Coverage Center Website using the “Contact Us” link. To be considered for the first quarterly review, nominations will need to be submitted by October 31, 2024. The deadlines for the next three quarterly review cycles are January 31, 2025, April 30, 2025, and July 31, 2025. See more information on the TCET pathway in the Federal Register and from AdvaMed. 

The Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691)

Just weeks ahead of CMS’ promised timeline to propose TCET in April 2023, the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691) was introduced to accelerate safe and effective life-changing and -saving therapies to Medicare patients.  This House bill seeks to provide four years of Medicare coverage for medical devices that receive approval from the FDA under the Breakthrough Devices Program. It would also create a roadmap for additional data collection for CMS to make a permanent coverage decision after the initial four years. 

H.R. 1691 rapidly gained growing support from bipartisan co-sponsors and national medical technology organizations, like AdvaMed and Medical Device Manufacturers Organization (MDMA), who expressed the importance of this legislation as a crucial element of the reforms ongoing within CMS. 

Following the introduction of H.R. 1691, CBSA urged members of the Colorado Congressional delegation to co-sponsor this bill and to encourage other members of Congress to take action to support this legislation as well. CBSA applauds Colorado U.S. Representatives Diana DeGette, Joe Neguse, Brittany Pettersen, Yadira Caraveo, and Jason Crow for signing-on as co-sponsors of H.R. 1691. The bill has now amassed 87 co-sponsors. 

On June 27, 2024, the House Ways & Means Committee passed an amended version of H.R. 1691. Congress must take swift action to advance this legislation as it is vital to ensure that older Americans gain access to critical, life-saving novel technologies being developed by our life sciences community. CBSA continues to collaborate with our national partners at AdvaMed and MDMA on outreach regarding H.R. 1691. 

If you are interested in contributing to CBSA’s advocacy efforts, please reach out to CBSA’s Vice President and Counsel for Policy + Advocacy.