Can TCET Accelerate Medicare Coverage for Breakthrough Devices?

August 13, 2024
Can TCET Accelerate Medicare Coverage for Breakthrough Devices?

The Centers for Medicare & Medicaid Services (CMS) has unveiled a groundbreaking procedural notice to speed up Medicare coverage for emerging medical devices through the new Transitional Coverage for Emerging Technologies (TCET) pathway. Proposed in June 2023, this pathway follows earlier efforts to streamline Medicare coverage, specifically the more ambitious Medicare Coverage of Innovative Technology (MCIT) rule suggested during the Trump administration. The TCET initiative addresses long-standing concerns regarding the lengthy Medicare coverage determinations for breakthrough medical devices.

Since the inception of the FDA’s Breakthrough Device designation, which aims to expedite regulatory review for novel and potentially more effective devices for serious conditions, stakeholders have faced significant delays between FDA authorization and CMS coverage decisions. Despite the accelerated FDA process, the average wait time for CMS coverage can exceed five years, creating a critical gap that frustrates device manufacturers and patient advocacy groups. This delay hinders timely access to life-saving treatments for Medicare recipients, making the need for a more streamlined and efficient coverage pathway pressing.

Addressing the Gap Between FDA Authorization and CMS Coverage

Historically, the gap between FDA market authorization and subsequent CMS coverage determinations has been a significant pain point for stakeholders, including device manufacturers and patient advocacy groups. Even with the FDA’s Breakthrough Device designation, which expedites regulatory review, the slow pace of CMS coverage decisions—averaging over five years—has been a major bottleneck. This delay prevents timely access to innovative treatments for Medicare beneficiaries, underscoring the need for a more effective solution to bridge this critical gap.

The TCET pathway aims to close this gap by integrating a more efficient and transparent Medicare coverage review process. Emphasizing increased pre-market engagement, the pathway seeks to use fit-for-purpose studies to fill existing evidence gaps. CMS, in collaboration with the Agency for Healthcare Quality and Research (AHRQ), has reworked its evidence review process to be more agile and responsive to stakeholder input. This collaborative approach is intended to make the review process more interactive and efficient, ensuring that Medicare beneficiaries can access breakthrough medical devices more quickly and reliably.

Enhancements in Transparency and Expediency

The TCET final procedural notice introduces several key enhancements designed to improve transparency and expedite the review process. One significant change is the allowance for manufacturers to submit non-binding letters of intent 18-24 months prior to expected FDA marketing authorization. This proactive measure enables CMS to conduct preliminary clinical endpoints reviews well ahead of time, thereby speeding up the overall process. The ability to get a head start on these reviews is expected to substantially shorten the timeline for Medicare coverage determinations, addressing a long-standing bottleneck in the system.

Devices accepted into the TCET pathway can hold a temporary national coverage decision status indefinitely until sufficient evidence is collected for a definitive coverage determination. While CMS expects this transitional status to last for at least five years, the final notice limits the review to five devices annually. This annual cap has sparked concerns among stakeholders and legislators, who argue that the limited pipeline may not have a significant impact on Medicare beneficiaries’ access to new technologies. To further increase transparency, CMS will publish a tracking sheet, submission dates, and review times on its website. The creation of a TCET dashboard will display accepted devices, and public comments will be solicited to enhance the transparency of the entire process.

However, it’s worth noting that CMS has not yet published the final criteria for prioritizing devices. In the interim, it will rely on a 2013 guidance document and prioritize devices that have the most significant potential impact on Medicare. This approach has garnered mixed reviews, as some stakeholders feel that more concrete and updated guidelines are necessary to ensure the initiative’s success.

Exclusions and Their Impact on Stakeholders

One of the most notable exclusions from the TCET pathway is in vitro diagnostic products, a decision that has disappointed many stakeholders. Breakthrough diagnostic technologies have the potential to save lives and reduce healthcare costs through early detection, and their exclusion is viewed by many as a significant oversight. Scott Whitaker, President and CEO of the Advanced Medical Technology Association (AdvaMed), has emphasized the need for congressional action to expand the TCET initiative and improve CMS resources to better accommodate these essential diagnostic tools.

Whitaker is advocating for the approval of the Ensuring Access to Critical Breakthrough Products Act (HR 1691), a bill designed to provide more comprehensive support for innovative medical devices and diagnostics. He argues that the final TCET notice, as it stands, does not fully address the needs of Medicare seniors who rely on breakthrough diagnostics and treatments. According to Whitaker, the exclusion of diagnostic products from the TCET pathway is a glaring omission that needs to be rectified to ensure a more inclusive and effective initiative.

The Potential and Limitations of TCET

The Centers for Medicare & Medicaid Services (CMS) has issued a pioneering procedural notice aiming to expedite Medicare coverage for new medical devices via the Transitional Coverage for Emerging Technologies (TCET) pathway. Proposed in June 2023, this initiative is a follow-up to earlier efforts, notably the Medicare Coverage of Innovative Technology (MCIT) rule introduced during the Trump administration. The TCET pathway seeks to resolve persistent concerns about the protracted Medicare coverage determinations for breakthrough medical devices.

Since the FDA’s Breakthrough Device designation began, aimed at speeding up regulatory review for innovative and potentially more effective devices for serious conditions, stakeholders have encountered significant delays between FDA approval and CMS coverage decisions. While the FDA accelerates the approval process, CMS often takes over five years to provide coverage, frustrating device manufacturers and patient advocacy groups. This significant lag impedes timely access to life-saving treatments for Medicare beneficiaries, highlighting the urgent need for a more streamlined and efficient Medicare coverage pathway.

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