Weekly Policy Blog: CBSA and Partners Provide Recommendations to Improve CMS’ Transitional Coverage for Emerging Technologies (TCET) Proposal 

CBSA advocates for policies that improve patient access to life-saving novel technologies. This week, CBSA signed on to a letter responding to the long-awaited proposed Transitional Coverage for Emerging Technologies (TCET) pathway, which is an important opportunity for our industry and CMS to modernize the coverage process, allowing swifter access to innovative technologies and therapies for Medicare beneficiaries. 

Spearheaded by our national partners at AdvaMed’s State Medical Technology Alliance, the letter offers recommendations to improve the existing TCET proposal. While the TCET notice released in late June is a positive step forward, we believe more can be done to ensure patients have timely access to new technologies soon after they are approved by the FDA. 

CBSA and Partner Engagement on TCET 

CBSA is collaborating with our national partners at AdvaMed and MDMA on outreach regarding TCET. 

In October 2022, CBSA encouraged members of the Colorado Congressional Delegation to join a Senate sign-on letter requesting that CMS release the proposed TCET rule by the end of the year. Additionally, in March 2023, CBSA met with members of our delegation virtually, urging them to reach out to CMS and encourage release of the proposed TCET rule. 

This week, CBSA signed on to a letter spearheaded by our national partners at AdvaMed’s State Medical Technology Alliance (SMTA) thanking CMS for introducing the proposed TCET pathway and providing recommendations to improve the current TCET proposal. While the TCET notice is a positive step forward, we believe more can be done to ensure patients have timely access to new technologies soon after they are approved by the FDA. Therefore, in addition to providing recommendations to improve the existing proposal, the SMTA is committed to working with the Agency, the Administration, and Congress to pass legislation and explore ways CMS can use its existing authority to build on the TCET program and enable more robust beneficiary access to safe and innovative medical technologies.  

Considering this understanding and commitment, we make the following recommendations regarding the TCET program: 

Recommendation: Include diagnostic laboratory tests as appropriate candidates for the TCET program 

Explanation: The TCET notice states CMS believes most coverage determinations for diagnostic laboratory tests granted Breakthrough Device designation should continue to be determined by the Medicare Administrative Contractors (MACs) through existing pathways. However, diagnostic laboratory tests are not the only area where review has historically occurred under the MACs. In addition, specialized MACs are not a suitable substitute for the national coverage offered under the TCET program. For example, the MolDx Program only makes coverage determinations for molecular diagnostics and establishes coverage for six MAC jurisdictions. Reliance on this program or other MAC-level review greatly limits coverage opportunities for new and novel in vitro diagnostics. Like the Medicare Coverage of Innovative Technologies (MCIT) final rule, we believe any medical device receiving Breakthrough designation by the FDA, and that meets all other TCET criteria, should be eligible for the pathway. 

Recommendation: Remove the annual cap on nominations to ensure the TCET program can be fully leveraged to improve patient access 

Explanation: CMS anticipates that while it will receive eight nominations per year for the TCET pathway, resource constraints will limit the Agency to only accepting five annually. As noted above, we understand that the TCET program is limited by resources available to CMS; similarly, the SMTA is committed to working with others to increasing resource access to build on a final TCET policy. However, resource constraints should not dictate policymaking or beneficiary access to innovative technologies. We therefore believe any product meeting the TCET program eligibility criteria should have the option to pursue the pathway, free of any annual numerical restriction. 

Recommendation: Include an appropriate lookback period for recently authorized Breakthrough products 

Explanation: The TCET notice does not contain defined or required timelines for when the TCET program will be finalized, which creates added uncertainty for manufacturers that are nearing or may have been recently granted FDA authorization through the Breakthrough program. These technologies should be given an opportunity to pursue nomination, but the TCET notice as currently drafted does not address program access for technologies other than those approximately 12 months away from FDA market authorization. To address this concern, the final TCET notice should include a lookback provision to allow TCET eligibility for breakthrough technologies, including those nearing authorization (i.e., less than 12 months).  

Recommendation: Ensure clear timelines for review of benefit category, coding, and payment 

Explanation: The TCET notice lacks clarity on certain processes, such as determination of Medicare benefit category, coding, and payment. Defining these steps with clear timelines for CMS review will help achieve the goal of the TCET program being an accelerated pathway for appropriate patient access to novel and innovative products. 

Recommendation: Improve transparency in the TCET program nomination process 

Explanation: CMS’ current method for managing the National Coverage Determination (NCD) process – requests, prioritizing topics, and providing information to the public regarding the waiting list – lacks transparency. The lack of specified timeline for CMS to respond to requests, or follow-up for more information, significantly hinders stakeholders’ ability to understand process and timing. 

Similar issues exist within the TCET notice. The proposal does not include public tracking of requests until an NCD is initiated; meaning any details around number of nominations or acceptances are not public. To ensure the TCET program operates as intended, CMS must provide greater transparency into these processes as part of the final policy. 

We applaud CMS’ commitment to ensuring Medicare beneficiaries have access to new and innovative technologies and look forward to a final policy that incorporates the above recommendations as the next step in improving the lives of patients with debilitating and life-threating conditions. 

Other Activity 

In addition to the progress made on TCET, the bipartisan Ensuring Patient Access to Critical Breakthrough Products Act of 2023 (H.R. 1691), which was introduced by Reps. Brad Wenstrup (R-OH) and Suzan DelBene (D-WA) on March 31st, has garnered growing support with 52 co-sponsors. CBSA applauds Colorado U.S. Representative Diana DeGette for signing on as a co-sponsor of H.R. 1691. 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. 

To learn more, read CBSA’s last policy blog about how CBSA Advocates for Medicare Coverage of Emerging Technologies and visit our national partner AdvaMed’s website, which has additional information on TCET and CMS’s Proposed Rule for Breakthrough Technology Coverage. 

See also: MDMA Comment Letter to CMS on the TCET Notice

Categories: CBSA News