AI summary from Chat GPT of Kadakia et al, TCET op ed, in NEJM on 11/30/2023.
The Op-Ed from the New England Journal of Medicine, written by Kushal T. Kadakia, Daniel B. Kramer, and Robert W. Yeh, provides a critical perspective on the Medicare coverage of emerging medical technologies, particularly focusing on the Breakthrough Devices Program and the Transitional Coverage for Emerging Technologies (TCET) pathway.
The authors discuss the challenges in bridging the gap between FDA authorization and Medicare coverage for new medical devices. They note that while the FDA authorizes nearly 3,000 new medical devices each year, including breakthrough devices intended to address unmet medical needs or life-threatening conditions, these devices often face delays in Medicare coverage and challenges in postmarketing surveillance. This delay affects patient access to new technologies, as insurance coverage determines accessibility.
The article reviews the Medicare Coverage of Innovative Technologies (MCIT) rule issued in 2021 by the Trump administration, which granted automatic Medicare coverage to all FDA-authorized breakthrough devices for four years after authorization. This rule, however, was criticized for potentially undermining safety and was subsequently repealed by the Biden administration.
In response, CMS proposed the TCET pathway in 2023, aiming to expedite access to breakthrough devices while preserving Medicare's role in evidence generation. TCET allows manufacturers to participate in consultative meetings with CMS before FDA authorization to create evidence-development plans, with guaranteed national coverage determinations within six months after FDA authorization.
Despite these efforts, the authors argue that TCET does not address fundamental issues in Medicare's coverage policy, such as the need for improved infrastructure for evidence generation and the limitations of implementing reforms through regulation rather than legislation. They suggest that broader collaborative efforts and legislative action are required to effectively evaluate and cover emerging medical technologies in Medicare.
In summary, while TCET represents a step towards expedited access to new technologies for Medicare beneficiaries, it has limitations and does not fully resolve the challenges of linking regulatory approval with patient access to emerging medical technologies.
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Here, I asked for a 150 word summary of the paired podcast.
In this interview, Stephen Morrissey from the New England Journal of Medicine speaks with Dr. Robert Yeh, a professor at Harvard Medical School and director at Beth Israel Deaconess Medical Center, about Medicare coverage for emerging medical technologies. Dr. Yeh explains that many medical devices, even after FDA approval, are not covered by Medicare. Coverage typically occurs through local coverage determinations by Medicare Administrative Contractors or, less frequently, through national coverage determinations by CMS.
Dr. Yeh discusses the 2016 introduction of the FDA's "Breakthrough Devices" designation for devices addressing unmet needs in life-threatening or debilitating conditions. About 900 devices have received this designation, with around 80 authorized, predominantly in the cardiovascular category.
The interview also covers the Trump administration's controversial MCIT proposal, which granted automatic Medicare coverage for four years to all breakthrough devices after FDA approval but was repealed by the Biden administration. This led to the proposal of the Transitional Coverage for Emerging Technologies (TCET), allowing manufacturers to engage with CMS prior to FDA approval, assuring a national coverage decision within six months of approval. This approach aims to expedite coverage decisions and involves CMS in evidence evaluation, potentially using real-world data.
However, Dr. Yeh notes limitations in the TCET, including its initial restriction to five devices per year and the potential underutilization, similar to the previously undersubscribed parallel review pathway. He also mentions the challenge of CMS's limited resources in evaluating a large number of devices.
Lastly, Dr. Yeh highlights the limitations of implementing reforms through regulation instead of legislation, noting the instability and changeability of rules and the challenges in passing relevant legislation given the current political climate.
