Today, September 23, 2024, CMS held a one hour webinar, half Q&A, about its Transitional Coverage for Emerging Technologies. Here we provide a link to an Auto Transcript and an AI Article about the event.
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TCET is pathway for getting an NCD for FDA breakthrough devices, which petition to enter the TCET-CED program about a year before their expected FDA approval. As emerged in the Q&A, CMS thinks entry of IVD diagnostics into TCET will be uncommon, but it's not impossible. CMS said they will soon hold a webinar about submitting request letters.
Auto-transcripts aren't as good as human transcripts, but, here is an instant one:
CMS said they will, eventually, post an official transcript.
A screen-grab video is here: https://youtu.be/bDjlu75EeNE
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AI CORNER
Below is an auto-article, based on the transcript, and generated by Chat GPT o1.
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In a move to streamline Medicare coverage for innovative medical devices, the Centers for Medicare & Medicaid Services (CMS) hosted a webinar on the new "Transitional Coverage for Emerging Technologies" (TCET) pathway. The hour-long session, held earlier this afternoon, detailed how the TCET aims to bridge the gap between FDA market authorization and Medicare coverage, ensuring beneficiaries have timely access to breakthrough medical devices.
[In general, the presentation hewed closely to explaining what was already published in the Final Rule - BQ.]
A Collaborative Effort for Faster Access
Dr. Dora Hughes, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality (CCSQ), opened the webinar by emphasizing the agency's commitment to fostering innovation while safeguarding beneficiary health. "People with Medicare deserve faster and more consistent access to emerging technologies that will improve health outcomes," Dr. Hughes stated. She highlighted that the TCET pathway is voluntary and specifically targets certain FDA-designated breakthrough devices.
Under the TCET, CMS plans to coordinate closely with the FDA and device manufacturers during the premarket review process. This collaboration aims to expedite National Coverage Determinations (NCDs), with a goal of finalizing coverage within six months after FDA market authorization. "The new pathway provides manufacturers with opportunities for increased premarket engagement with CMS and a new, unprecedented level of flexibility to address any evidence gaps for coverage," Dr. Hughes added.
Navigating the TCET Pathway
Dr. Steven Farmer, Chief Strategy Officer at CCSQ's Coverage and Analysis Group, provided an in-depth presentation on the mechanics of the TCET pathway. He underscored the challenges that emerging technologies often face in obtaining prompt Medicare coverage, citing issues like misalignment with existing benefit categories and insufficient evidence applicable to Medicare beneficiaries.
"CMS and FDA have different mandates and operate under different legal authorities," Dr. Farmer explained. While the FDA assesses safety and effectiveness, CMS determines whether an item or service is "reasonable and necessary" for the Medicare population. This distinction necessitates a tailored approach to coverage decisions for breakthrough devices.
The TCET pathway is structured in several stages:
Pre-Market Stage: Manufacturers are encouraged to engage with CMS up to 24 months before anticipated FDA market authorization. Early submission of a non-binding Letter of Intent can improve CMS's ability to plan resources and coordinate reviews.
Near-Market Stage: CMS conducts an evidence preview and works with manufacturers to identify the best available coverage options. Enhanced coordination with FDA and the Agency for Healthcare Research and Quality (AHRQ) is a key feature of this stage.
Early Post-Market Stage: If evidence gaps exist, manufacturers can address them through "fit-for-purpose" studies, which may include real-world data. CMS aims to provide transitional coverage while these studies are conducted.
Late Post-Market Stage: CMS assesses the new evidence and may reconsider NCDs, potentially lifting any coverage with evidence development (CED) requirements.
Addressing Stakeholder Concerns
During the Q&A session, CMS officials tackled several pressing questions from stakeholders/
[Answers usually hewed closely to verbiage in the TCET final rule or other prior CMS policies - BQ].
Eligibility and Timing: Devices already in the market or those close to FDA market authorization may not be ideal candidates for TCET. CMS emphasized the importance of early engagement to fully leverage the pathway's benefits.
Diagnostic Lab Tests: While generally excluded from TCET due to their specific coverage policies available at local contractors, CMS acknowledged that NCDs might be appropriate in certain cases. Manufacturers are encouraged to discuss options with CMS.
Prioritization Criteria: CMS plans to prioritize devices based on impact on the Medicare program and beneficiaries, considering both the magnitude of benefit and the number of patients affected. [This is based on existing policy published in 2013.] Health equity impact will also be a factor.
Coding and Payment: TCET aims to better align coding and payment processes by initiating reviews well before FDA market authorization. Manufacturers are urged to proactively pursue codes to facilitate this alignment.
Medicare Advantage Plans must cover TCET NCD's, just like other NCDs.
Implications for the Healthcare Landscape
The TCET pathway represents a significant shift in how CMS approaches coverage for emerging technologies. By fostering early collaboration and providing clear guidance, CMS seeks to reduce uncertainty for manufacturers and accelerate beneficiary access to cutting-edge medical devices.
According to the CMS speakers, manufacturers stand to benefit from a more predictable and transparent coverage process, while clinicians and patients could see faster availability of innovative treatments. However, the pathway also places an emphasis on rigorous evidence applicable to the Medicare population, ensuring that new technologies deliver meaningful health outcomes.
As the TCET pathway rolls out, CMS plans to provide additional guidance and hold workshops to assist manufacturers in navigating the nomination process. With the first quarterly review cycle's nomination deadline set for October 31, 2024, stakeholders are encouraged to engage early to take full advantage of this new opportunity.
Conclusion
CMS's introduction of the TCET pathway marks the agency's effort to bridge the gap between innovation and patient access within the Medicare program. By addressing longstanding challenges and incorporating stakeholder feedback, CMS is hopes that TCET enhance the adoption of high-value medical technologies.
