TCET pathway may broaden access to breakthrough devices, but reforms still needed

While the Transitional Coverage for Emerging Technologies (TCET) pathway proposed by the Centers for Medicare and Medicaid Services (CMS) offers the potential to speed access to breakthrough medical devices, it also highlights the pitfalls of implementing coverage reform through rulemaking, according to a recent perspective published in The New England Journal of Medicine.

“[M]ost novel devices lack any form of Medicare coverage 5 years after authorization, with local determinations relying on inconsistent standards and national determinations being significantly delayed,” Kushal T. Kadakia, of Harvard Medical School in Boston, and colleagues wrote. “Although rigorous assessment of health technologies is necessary to ensure appropriate use, the current system does not meet the goals of patients or policymakers, and many stakeholders have therefore called for reforms.”

When the Trump administration issued the Medicare Coverage of Innovative Technologies (MCIT) rule in 2021, it made Medicare coverage of breakthrough devices automatic for four years after authorization by the US Food and Drug Administration (FDA). However, the rule was criticized by some policy experts who said it undermined the role of CMS in examining evidence surrounding adoption of a device. It was later repealed under the Biden Administration.

In June 2023, CMS proposed the TCET pathway, which Kadakia and colleagues wrote was “designed to achieve MCIT’s goal” of expedited access to breakthrough devices by starting coverage determination processes earlier and granting Medicare its previous ability of independent evidence generation.

“TCET aims to reduce uncertainty about coverage options through a pre-market evaluation of potential harms and benefits of technologies while identifying any important evidence gaps,” CMS wrote in a blog post announcing the pathway. “In addition, the TCET pathway will help coordinate benefit category determination, coding, and payment reviews. Finally, TCET allows manufacturers to address any evidence gaps through fit-for-purpose studies.”

Compared to the Trump administration’s MCIT rule, TCET “restores CMS’s role in device regulation,” Kadakia and colleagues wrote, but highlighted several limitations to the pathway’s approach. For instance, TCET is similar to the CMS-FDA Parallel Review program, which the authors said had a limited impact, with just 96 total applicants and two successful joint decisions occurring over a decade.

“Although the proposed meeting cadence and review process under TCET may provide much needed structure, the creation of this pathway does not address Parallel Review’s core problems, including manufacturers’ reluctance to take on the additional commercial risk involved in designing premarketing studies that meet both agencies’ expectations,” Kadakia and colleagues wrote.

Another issue with TCET is the timing of the review by CMS. At 12 months prior to FDA authorization, a manufacturer is likely to have already begun pivotal clinical trials, too late to effectively incorporate feedback on premarket study design issues. The authors proposed instead that TCET pathway applications should be submitted at the point when a manufacturer is granted breakthrough designation status for the device, allowing CMS to weigh in on pivotal clinical trials.

Other concerns include the use of Medicare’s Coverage with Evidence Development (CED) program in the postmarketing stage for TCET. A major challenge with the CED program is the use of “costly, one-off, product-specific registries or studies” rather than common research infrastructure, which is beyond the purview of Medicare. CMS officials have signaled that in the TCET pathway, they intend to develop advisories on indication and specific technologies for manufacturers, but Kadakia and colleagues wrote that these initiatives are “insufficient to address legitimate criticisms of CED’s current model.”

“The expedited national coverage determination process will probably shorten the time between FDA authorization and patient access to new technologies, while the evidence-development plans and CED advisories will inform decisions about technologies with evolving risk– benefit profiles by prioritizing considerations that are specific to Medicare beneficiaries,” Kadakia and colleagues wrote. However, while Medicare coverage reform over the last several decades has come in the form of rulemaking, this is a double-edged sword that “makes new programs vulnerable to changes in presidential administration” such as was the case with MCIT, the authors noted.

Using legislation to make reforms to coverage pathways could help overcome some of the limitations of a regulatory approach. However, lawmakers have so far not reached common ground on how to advance device coverage legislation. “Indeed, for its past three sessions, Congress has considered but failed to pass proposals for codifying MCIT into law, which illustrates the lack of consensus on coverage reform and the need for lawmakers to define and provide resources for Medicare’s mandate for evaluating emerging medical technologies,” Kadakia and colleagues wrote.

The authors reported having no relevant conflicts of interests.

NEJM Perspective

TCET pathway may broaden access to breakthrough devices, but reforms still needed

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