HEADER: CMS held a webinar on September 23, 2024, to explain operations of the "TCET" NCD CED program which was announced on August 6, 2024. Now, CMS releases a trancript.
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TCET NCD CED for BT Devices - Let's parse the abbreviations Transitional Coverage for Emerging Technologies; applicable only to FDA Breakthrough (BT) Devices; for National Coverage Decisions on an accelerated 6-month basis, deploying "Coverage with Evidence Development."
CMS has now released a 14 page transcript of its TCET webinar. The transcript includes a link to the archive video. There was several interesting slides in the video that were novel to me, but CMS didn't release a separate PDF presentation deck.
Below, I provide an AI "News Story" and a full AI summary of the Q&A, both from Chat GPT. Then I pivot to a new services, Google Notebook LM. GNLM lets you create a folder, load several documents too it, and then it will provide at least four pre-designed reports; (1) a briefing, (2) a study guide with AI Q&A; (3) a timeline and list of speakers; and finally and most notable (4) a ten minute AI podcast with two AI voices chatting to one another - a fully synthetic"podcast."
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Before we pivot to the AI material, here's an essay by Joe Grogan:
Republican health policy expert Joe Grogan has just listed some downsides of the TCET policy in a new article at The Hill,
https://thehill.com/opinion/healthcare/4889436-biden-harris-medical-innovation/
Grogan writes,
[Past the FDA,] innovators must still confront an uncooperative CMS, which keeps finding excuses to deny coverage at every turn.
One strategy used by the agency is “Coverage with Evidence Development,” which requires additional clinical trials on top of those conducted for the FDA.
These requirements can span decades. Of the 27 devices or procedures subjected to this procedure since 2005, only four were not still undergoing it as of April 2022. The evidence development system has been corrupted.
Originally designed to accelerate innovation, it now poses a huge obstacle. A moratorium on new Coverage with Evidence Development programs is needed until it can be fixed or scrapped.
(Not Shown: When Grogan's view was shared with Google Notebook, which had trained on the CMS-origin materials, Google Notebook said that CMS was at least trying to rebut his concerns, and provided a hotlink to paragraphs in the 14-page transcript with regard to each point made in Grogan's essay.)
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AI CORNER - CHAT GPT Report and Q&A
Chat GPT writes up the transcript. Plus the Q&A after.
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CMS Hosts Webinar on TCET Pathway,
Highlighting Changes in Coverage for Breakthrough Devices
The Centers for Medicare & Medicaid Services (CMS) held a public webinar on September 23, 2024, to educate stakeholders on its newly established Transitional Coverage for Emerging Technologies (TCET) pathway. This pathway is designed to accelerate Medicare coverage decisions for FDA-designated Breakthrough Devices. The event featured presentations by Dr. Dora Hughes, CMS Chief Medical Officer, and Dr. Steve Farmer, Chief Strategy Officer in the Coverage and Analysis Group, who elaborated on the TCET pathway’s significance and functionality.
The TCET pathway is aimed at facilitating faster Medicare access to medical innovations while ensuring safety and effectiveness for Medicare beneficiaries. It supports manufacturers by providing a predictable and transparent review process that coordinates both coverage and evidence development. This is achieved through CMS’s use of the National Coverage Determination (NCD) and Coverage with Evidence Development (CED) frameworks, allowing for the incorporation of fit-for-purpose studies into the approval process. As Dr. Hughes noted, “CMS is committed to fostering innovation while ensuring that people with Medicare have faster access to technologies that will improve their health outcomes.”
Dr. Farmer provided further insights into the operation of the TCET pathway, which builds on existing CMS authorities and emphasizes early engagement with manufacturers. The pathway is structured in different stages: premarket, near-market, and postmarket. In the premarket stage, manufacturers can engage with CMS to clarify coverage expectations, ensuring alignment with FDA requirements. A key feature of the pathway is the Evidence Preview, which assesses the available evidence on a device’s safety and effectiveness. Manufacturers can collaborate with CMS and the Agency for Healthcare Research and Quality (AHRQ) to identify and address any evidence gaps before market authorization.
One notable aspect of the TCET pathway is its capacity for flexibility in evidence generation. Manufacturers can conduct fit-for-purpose studies to provide data suited to the specific needs of the Medicare population, which typically differs from the populations included in FDA trials. “Fit-for-purpose studies, including those using real-world data, provide complementary perspectives that enhance the evidence base for coverage decisions,” explained Dr. Farmer.
The webinar also covered specific criteria for devices eligible for the TCET pathway. These include FDA Breakthrough designation, alignment with a Medicare benefit category, and the absence of an existing NCD for the device. A key advantage of the pathway is the ability to expedite the NCD process, with CMS aiming to finalize NCDs within six months of FDA market authorization.
Attendees raised several questions about the logistics of the new pathway. A significant portion of the discussion focused on how devices that are nearing FDA approval would be prioritized. Lori Ashby, a member of the CMS team, clarified that while devices close to receiving FDA market authorization might not qualify for TCET due to the expedited nature of the pathway, they can still pursue coverage through other established processes, such as Local Coverage Determinations (LCDs) by Medicare Administrative Contractors.
CMS plans to expand the transparency and efficiency of the TCET pathway with future guidance documents. These will include detailed protocols for fit-for-purpose studies and real-world data use, as well as prioritization factors for determining which devices enter the pathway. Manufacturers interested in the pathway are encouraged to submit a voluntary letter of intent up to 24 months before FDA market authorization to allow CMS to track potential candidates.
This webinar marks a significant step in CMS’s efforts to modernize the Medicare coverage process and better integrate new medical technologies into the healthcare system. As Dr. Farmer concluded, “The TCET pathway represents a balanced approach that promotes early beneficiary access to breakthrough technologies while maintaining rigorous evidence standards.”
For more information on the TCET pathway and upcoming guidance documents, visit the CMS website or review the full transcript from the September 23 webinar.
Chat GPT continues by summaries the Q&A found in the latter part of the transcript of the webinar.
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Question 1: When does the one-year clock start for nominations? Is it August 12th since that is the date the policy was effective? Or after the first quarter review? And then what happens if there are delays in FDA market authorization?
Answer: Lori Ashby explained that the one-year clock starts approximately 12 months before anticipated FDA market authorization, not tied to the August 12th policy effective date or the quarterly review. Delays in FDA authorization don’t affect acceptance into the pathway, but CMS aims to complete TCET steps within that 12-month window.
Question 2: Is there a lookback period for Breakthrough Devices nearing FDA market authorization or those recently achieving it?
Answer: There is no lookback period. Devices already in the market or nearing FDA market authorization (less than 12 months) are not eligible for TCET and are better suited for other pathways like Local Coverage Determinations (LCDs) or claim-by-claim adjudication.
Question 3: How do software as a medical device and other digital health innovations fit into the TCET pathway?
Answer: CMS clarified that such technologies could be eligible if they meet the criteria outlined in the TCET notice. However, these technologies must fit within a Medicare benefit category under Part A or Part B. CMS is actively exploring this area in policy development, with ongoing interest from Congress.
Question 4: Why are diagnostic lab tests excluded from the TCET pathway?
Answer: CMS recognizes that diagnostic lab tests are regulated as medical devices and eligible for FDA Breakthrough designation. However, diagnostic tests are considered a highly specific area of coverage, typically reviewed by Medicare Administrative Contractors (MACs). NCDs for diagnostic tests are rare, but possible if manufacturers believe additional evidence is needed for Medicare coverage.
Question 5: How will CMS prioritize TCET nominations? Will they consider the impact on Medicare beneficiaries, particularly those with high-cost or less common diseases? Will health equity be a factor?
Answer: Lori Ashby stated that until further guidance is released, CMS will prioritize based on a 2013 Federal Register notice, which considers the magnitude of impact on the Medicare program. CMS will also consider health equity, giving priority to devices that address health disparities.
Question 6: How will CMS prioritize nominations if devices are moved from one quarterly review cycle to the next?
Answer: CMS will automatically reconsider devices not selected in the first review cycle in the next cycle. However, devices within six months of FDA market authorization may not be accepted into TCET due to the short timeframe for CMS to complete the NCD.
Question 7: What level of detail will CMS provide to manufacturers whose nominations are declined for reasons other than the cap being met?
Answer: CMS will provide a justification for declined nominations, including reasons such as the absence of an FDA Breakthrough designation or an existing NCD covering the device.
Question 8: Will CMS notify manufacturers if their device is no longer automatically considered in the next review cycle due to proximity to FDA approval?
Answer: CMS is developing a web-based system to automatically notify manufacturers of their nomination status, including acceptance, reconsideration in future cycles, or withdrawal from the TCET pathway.
Question 9: How will CMS make public the number of TCET applications, device types, and classes accepted into the program after each nomination cycle?
Answer: While the nominations themselves are confidential, CMS will update the NCD dashboard with the number of devices in the pathway, the date of nomination, acceptance, and the initiation of the NCD process. This dashboard will be updated quarterly.
Question 10: How does CMS use TCET nomination material to inform the Evidence Preview? Will the manufacturer’s list of studies be the basis for the Evidence Preview?
Answer: Steve Farmer explained that the Evidence Preview is informed by a systematic literature review conducted by a contractor, which is cross-referenced with the manufacturer's bibliography. Manufacturers can propose technical edits, and the review ensures the evidence is comprehensive.
Question 11: What is the purpose of voluntary letters of intent (LOI) 18 to 24 months before FDA market authorization? How does it benefit manufacturers?
Answer: Lori Ashby clarified that the LOI allows CMS to better predict potential TCET nominations and optimize the review process. While nonbinding, it improves coordination between CMS and the FDA and helps prevent delays in reviews.
Question 12: Is CMS planning any best practice training on how to submit a nomination?
Answer: Yes, CMS plans to conduct workshops to help manufacturers considering LOIs and nominations, with details to be provided soon.
Question 13: How will CMS and FDA coordinate the TCET process, given the reliance on FDA timelines for market authorization?
Answer: CMS regularly engages with FDA and AHRQ, as well as with manufacturers, to help coordinate the process. CMS plans to initiate the TCET process approximately one year before FDA authorization, incorporating trial results and addressing evidence gaps.
Question 14: How will CMS address coding and payment for devices accepted into TCET?
Answer: CMS encourages manufacturers to proactively pursue codes during the TCET process to avoid delays. CMS has also established a Pharmaceutical and Technology Ombudsman to assist with coverage, coding, and payment decisions.
Question 15: How soon before FDA approval can the Evidence Preview and Evidence Development Plan be initiated for follow-on devices?
Answer: Follow-on devices can engage CMS about 12 months before FDA market authorization to initiate an Evidence Preview and develop an Evidence Development Plan. This helps avoid delays in NCD establishment postmarket.
Question 16: Is there noncoverage for follow-on devices until CMS approves a CED study? How can this be minimized?
Answer: Yes, follow-on devices are noncovered until a CMS-approved CED study is in place. To minimize delays, manufacturers should initiate the Evidence Preview as early as possible, ideally 12 months before FDA approval.
Question 17: How will CMS prioritize the Evidence Preview and EDP for follow-on devices?
Answer: CMS believes it has sufficient resources to conduct timely reviews for both first-to-market and follow-on devices.
Question 18: Has the use of a contractor for technical analyses reduced the processing time for NCDs? How will CMS handle the TCET workload?
Answer: CMS has streamlined processes through contractor support, allowing for specialized clinical expertise and greater efficiency. This will help accommodate the additional workload from TCET without affecting other NCDs.
Question 19: What is the anticipated timing of future CMS guidance on fit-for-purpose (FFP) studies, real-world data protocols, and prioritization guidance?
Answer: CMS expects to release guidance on fit-for-purpose studies and real-world data protocols soon. Prioritization guidance will follow after several quarterly review cycles.
Question 20: How will CMS prioritize coverage for devices within six months of FDA market authorization if they are not accepted into TCET?
Answer: Devices nearing market authorization can pursue conventional NCDs if they are not accepted into TCET. CMS will prioritize NCD requests based on their potential impact on the Medicare program and beneficiaries.
Question 21: Will Medicare Advantage plans have to cover devices under TCET?
Answer: Yes, Medicare Advantage plans must cover devices under TCET NCDs just as they do with conventional NCDs.
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Now we switch programs and go over the Google Notebook LM. We create a folder for TCET. We upload the one-hour transcript, just like we gave Chat GPT before. This time, we let Google Notebook lM do its free pre-fab functions, like "Timeline." (Below).
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AI Below is All From Google Notebook LM
Timeline of Events (Google Notebook LM auto function)
2015:
- Ongoing: The FDA Breakthrough Devices Program has granted over 930 Breakthrough Designations.
2022:
- November: The Agency for Healthcare Research and Quality (AHRQ) publishes a report on Coverage with Evidence Development (CED).
2023:
- February: The Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) holds a meeting to discuss AHRQ's CED report.
2024:
- August 6: CMS issues a final procedural notice outlining the Transitional Coverage for Emerging Technologies (TCET) pathway for certain FDA-designated Breakthrough Devices.
- September 23: CMS hosts a webinar to provide an overview of the TCET pathway and answer stakeholder questions.
- October 31: Deadline for manufacturers to submit nominations for the first quarterly TCET review cycle.
2025:
- January 31: Deadline for the second quarterly TCET review cycle.
- April 30: Deadline for the third quarterly TCET review cycle.
- July 31: Deadline for the fourth quarterly TCET review cycle.
- Ongoing: CMS plans to publish additional guidance documents on fit-for-purpose studies, real-world data protocols, and TCET prioritization factors.
Cast of Characters
Centers for Medicare & Medicaid Services (CMS)
- Dr. Dora Hughes: CMS Chief Medical Officer and Director for the Center for Clinical Standards and Quality. Provides opening remarks at the TCET webinar, emphasizing CMS's commitment to innovation and timely patient access.
- Dr. Steve Farmer: Chief Strategy Officer in the Coverage and Analysis Group. Presents a detailed overview of the TCET pathway at the webinar.
- Lori Ashby: CMS representative who answers stakeholder questions during the TCET webinar.
Other Organizations
- Food and Drug Administration (FDA): Responsible for granting Breakthrough Device designations and overseeing the premarket review process for medical devices. Works closely with CMS on the TCET pathway.
- Agency for Healthcare Research and Quality (AHRQ): Collaborates with CMS on the CED pathway and provides feedback on Evidence Previews and Evidence Development Plans.
- Medicare Administrative Contractors (MACs): Process Medicare claims and make local coverage determinations. May continue to review diagnostic lab tests, even if they receive Breakthrough Device designation.
- Medicare Evidence Development and Coverage Advisory Committee (MEDCAC): Provides CMS with independent advice on coverage issues. Reviewed AHRQ's CED report in February 2023.
Key Terms
- Breakthrough Devices: Medical devices that demonstrate the potential to offer a more effective treatment for a life-threatening or irreversibly debilitating disease or condition, for which no approved or cleared alternatives exist.
- Transitional Coverage for Emerging Technologies (TCET): A Medicare coverage pathway that provides expedited coverage for certain FDA-designated Breakthrough Devices.
- National Coverage Determination (NCD): A national Medicare policy that determines whether a particular item or service is covered by Medicare.
- Coverage with Evidence Development (CED): A Medicare coverage pathway that allows for coverage of promising new technologies while requiring manufacturers to conduct additional clinical studies to demonstrate long-term safety and effectiveness.
- Evidence Preview: A focused literature review that provides early feedback on the strengths and weaknesses of the available evidence for a particular technology.
- Evidence Development Plan (EDP): A plan developed by the manufacturer to address any evidence gaps identified in the Evidence Preview. May include traditional clinical studies and/or fit-for-purpose studies using real-world data.
- Fit-for-purpose study: A study where the design, analysis plan, and data sources are appropriate to address the specific research question at hand.
- Real-world data: Data collected from sources outside of traditional clinical trials, such as electronic health records, claims databases, and patient registries.
This timeline and cast of characters should provide a good starting point for understanding the key events and players involved in the TCET pathway.
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Briefing Doc: CMS Transitional Coverage for Emerging Technologies (TCET) Pathway
Date: October 26, 2024
Subject: Overview of the TCET Pathway and Key Takeaways from the September 23rd Webinar
Background:
The Centers for Medicare & Medicaid Services (CMS) has finalized the Transitional Coverage for
Emerging Technologies (TCET) pathway to accelerate Medicare coverage for innovative medical devices designated as "Breakthrough Devices" by the FDA. This briefing document summarizes the key themes and important details of the TCET pathway based on two CMS sources:
- CMS Fact Sheet (August 6, 2024): Provides an overview of the TCET pathway, its goals, eligibility criteria, and the process for manufacturers.
- CMS Webinar Transcript (September 23, 2024): Offers deeper insights into the TCET pathway, addressing specific questions from stakeholders.
Main Themes:
- Accelerated Coverage: The TCET pathway aims to reduce the time lag between FDA market authorization and Medicare coverage for Breakthrough Devices, improving patient access to cutting-edge treatments.
- Predictability and Transparency: The pathway provides manufacturers with a clear and predictable process, outlining evidence requirements and timelines for coverage decisions.
- Collaboration and Engagement: CMS emphasizes collaboration with FDA, AHRQ, manufacturers, and other stakeholders throughout the process.
- Evidence Development: TCET encourages the generation of real-world evidence through fit-for-purpose studies to support coverage decisions.
Key Ideas and Facts:
1. TCET Pathway Overview:
- Target: Certain FDA-designated Breakthrough Devices that fall within a Medicare benefit category.
- Goal: To finalize a National Coverage Determination (NCD) within six months of FDA market authorization.
- Process:Pre-Market: Manufacturers submit a nomination, CMS conducts an Evidence Preview and, if necessary, develops an Evidence Development Plan (EDP) with the manufacturer.
- Post-Market: CMS finalizes an NCD, which may include Coverage with Evidence Development (CED) requirements.
- Post-TCET: CMS will reconsider the NCD based on the EDP timeline and evidence generated.
2. Device Eligibility:
- FDA-designated Breakthrough Devices.
- Within a Medicare benefit category.
- Not already subject to an existing NCD.
- Not excluded from coverage by law or regulation.
3. Nominations and Prioritization:
- Manufacturers self-nominate approximately 12 months before anticipated FDA market authorization.
- CMS accepts nominations quarterly and prioritizes them based on potential impact on the Medicare program and beneficiaries.
- A non-binding letter of intent can be submitted 18-24 months before anticipated FDA market authorization.
4. Evidence Development:
- Evidence Preview: A collaborative review of existing evidence, conducted by CMS, AHRQ, and the manufacturer.
- Evidence Development Plan (EDP): If evidence gaps exist, an EDP is developed to outline fit-for-purpose studies.
- Fit-for-Purpose Studies: Studies designed to address specific evidence needs using appropriate designs and data sources, including real-world data.
5. Coverage Duration and Transition:
- Transitional Coverage: Tied to the completion of the EDP, typically lasting five or more years.
- Post-TCET Coverage: CMS will reconsider the NCD and make a final coverage determination based on the generated evidence.
6. Key Takeaways from the September 23rd Webinar:
- Lookback Period: Devices already on the market are not eligible for TCET.
- Software as a Medical Device: Eligibility depends on meeting the TCET criteria and falling within a Medicare benefit category, which is still under development for SaMD.
- Diagnostic Lab Tests: Generally excluded from TCET, but manufacturers can contact CMS for individual consideration.
- Prioritization: CMS considers beneficiary impact, health equity, and available resources when prioritizing nominations.
- Letters of Intent: Help CMS predict demand and can potentially alleviate delays in the review process.
- Coordination with FDA: CMS emphasizes regular communication and collaboration with the FDA.
- Coding and Payment: CMS encourages proactive pursuit of codes and offers resources to assist manufacturers.
Quotes:
- "CMS is committed to fostering innovation while making sure that people with Medicare have faster access to technologies that will improve their health outcomes." - Dr. Dora Hughes, CMS Chief Medical Officer.
- "TCET aims to reduce uncertainty about coverage options through a premarket evaluation of potential harms and benefits of technologies while identifying any important evidence gaps." - Dr. Dora Hughes, CMS Chief Medical Officer.
- "We believe that manufacturers will be better positioned for multiple product development stages if they anticipate both FDA and CMS requirements when developing clinical studies." - Dr. Dora Hughes, CMS Chief Medical Officer.
Next Steps:
- Review the full CMS Fact Sheet and Webinar Transcript.
- Submit a letter of intent if you have a device that may be eligible for TCET.
- Review upcoming CMS guidance documents on fit-for-purpose studies, real-world data protocols, and prioritization factors.
Conclusion:
The TCET pathway represents a significant shift in Medicare's approach to covering emerging medical technologies. By emphasizing early engagement, collaboration, and evidence development, CMS aims to accelerate patient access to innovative treatments while ensuring the safety and effectiveness of care for the Medicare population.
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Transitional Coverage for Emerging Technologies (TCET) Pathway
Google Notebook TCET "Study Guide"
Purpose of TCET:
- The TCET Pathway is designed to expedite Medicare coverage for innovative medical devices designated as "Breakthrough Devices" by the FDA.
- It aims to balance timely access for Medicare beneficiaries with the need for robust evidence supporting the safety and effectiveness of new technologies.
Key Features:
- Voluntary: Manufacturers can choose to participate.
- Pre-market Engagement: CMS and manufacturers collaborate early to identify evidence gaps and develop Evidence Development Plans (EDPs).
- Expedited NCD Process: CMS aims to finalize NCDs within six months of FDA market authorization.
- Coverage with Evidence Development (CED): Coverage can be provided while evidence is being gathered through fit-for-purpose studies, including real-world data.
- Transitional Coverage: Coverage under TCET is time-limited, tied to the EDP, and typically lasts five or more years.
- Post-TCET Coverage: CMS will reconsider the NCD based on the generated evidence, leading to either continued coverage, modified coverage, or non-coverage.
Eligibility:
- FDA-designated Breakthrough Devices.
- Devices within a Medicare benefit category.
- Devices not already subject to an existing NCD.
- Devices not excluded from coverage by law or regulation.
Process:
- Pre-Market Stage: CMS publishes guidance documents to clarify evidence expectations and manufacturers submit a Letter of Intent 18-24 months before anticipated FDA market authorization.
- Near-Market Stage: Manufacturers formally nominate their device 12 months before anticipated FDA market authorization. CMS conducts an Evidence Preview and holds a stakeholder meeting.
- Early Post-Market Stage: If sufficient evidence exists, an expedited NCD is issued. If not, a CED NCD is issued with an agreed-upon EDP.
- Post-Market Stage: CMS reviews evidence generated through the EDP and reconsiders the NCD.
Benefits:
- For Medicare Beneficiaries: Faster access to potentially life-saving or life-improving technologies.
- For Manufacturers: Reduced uncertainty about Medicare coverage, clear evidence expectations, and a streamlined review process.
- For the Healthcare System: Encourages innovation and promotes the development of high-value, evidence-based medical technologies.
Google Study Guide Quiz
Instructions: Answer the following questions in 2-3 sentences each.
- What is the primary purpose of the TCET Pathway?
- Which medical devices are eligible for the TCET Pathway?
- Describe the role of the Evidence Development Plan (EDP) in the TCET process.
- How does the TCET Pathway benefit Medicare beneficiaries?
- What is the typical duration of coverage under a TCET NCD?
- What are the potential outcomes of the CMS NCD reconsideration after the completion of the EDP?
- How does the TCET Pathway encourage the use of real-world data in evidence generation?
- Explain the difference between an expedited NCD and a CED NCD under the TCET Pathway.
- What is the significance of the "Breakthrough Device" designation in the context of TCET eligibility?
- How does the TCET Pathway streamline the process for manufacturers seeking Medicare coverage for their devices?
Answer Key
- The TCET Pathway aims to expedite Medicare coverage for FDA-designated Breakthrough Devices, balancing timely patient access with the need for robust evidence.
- Eligible devices are FDA-designated Breakthrough Devices that fall within a Medicare benefit category, are not already subject to an NCD, and are not excluded from coverage by law or regulation.
- The EDP outlines a plan for addressing evidence gaps identified in the Evidence Preview and typically includes fit-for-purpose studies. It provides a roadmap for evidence generation that will inform the future NCD reconsideration.
- The TCET Pathway benefits Medicare beneficiaries by providing them with faster access to potentially life-saving or life-improving technologies that may not be covered through traditional Medicare pathways.
- Coverage under a TCET NCD is time-limited and tied to the EDP, typically lasting for approximately five or more years.
- After the completion of the EDP, the NCD will be reconsidered. Potential outcomes include: an NCD without evidence development requirements, an NCD with continued evidence development requirements, a non-coverage NCD, or rescinding the NCD.
- The TCET Pathway encourages the use of real-world data through fit-for-purpose studies, recognizing its value in generating evidence that reflects real-world patient populations and treatment settings.
- An expedited NCD is issued when sufficient evidence already exists to support coverage, while a CED NCD is issued when there are evidence gaps that need to be addressed through further studies. The CED NCD allows for coverage while evidence is being gathered.
- The "Breakthrough Device" designation is a prerequisite for TCET eligibility, as it indicates that the device has the potential to offer significant improvements over existing treatments for serious or life-threatening conditions.
- The TCET Pathway streamlines the process for manufacturers by providing clear evidence expectations, a defined timeline for review, and opportunities for early collaboration with CMS, reducing uncertainty and expediting coverage decisions.
Essay Questions
- Discuss the potential benefits and challenges of the TCET Pathway for Medicare beneficiaries, manufacturers, and the healthcare system as a whole.
- Explain the rationale for including coverage with evidence development (CED) as a key component of the TCET Pathway. How does CED balance the need for timely access to new technologies with the importance of evidence-based coverage decisions?
- Analyze the role of real-world data in the evaluation of emerging medical technologies. How can real-world data studies be designed to generate meaningful evidence to support coverage decisions under the TCET Pathway?
- Describe the collaboration between CMS and the FDA in the TCET process. How do the different mandates and regulatory frameworks of these agencies influence their respective roles in evaluating new medical technologies?
- Explore the potential long-term impact of the TCET Pathway on the innovation landscape for medical devices. How might the pathway influence the development, clinical trial design, and market access strategies for future Breakthrough Devices?
Glossary of Key Terms
- Breakthrough Device: A medical device designated by the FDA as offering significant improvements over existing treatments for serious or life-threatening conditions.
- CED (Coverage with Evidence Development): A CMS coverage pathway that allows for Medicare coverage of a new technology while additional evidence is being collected to support its safety and effectiveness.
- CMS (Centers for Medicare & Medicaid Services): The federal agency responsible for administering Medicare, Medicaid, and other healthcare programs.
- EDP (Evidence Development Plan): A plan outlining the studies and data collection activities that will be conducted to address evidence gaps identified in the Evidence Preview.
- Evidence Preview: A focused literature review conducted by CMS to assess the available evidence on a new technology.
- FDA (Food and Drug Administration): The federal agency responsible for regulating the safety and effectiveness of medical devices, drugs, and biologics.
- Fit-for-Purpose Study: A study designed to address specific evidence gaps relevant to Medicare coverage, often incorporating real-world data.
- NCD (National Coverage Determination): A national policy that determines whether Medicare will cover a particular item or service.
- Real-World Data: Data collected outside of traditional clinical trials, reflecting real-world patient populations, treatment settings, and clinical practices.
- TCET (Transitional Coverage for Emerging Technologies): A CMS pathway that provides expedited Medicare coverage for certain FDA-designated Breakthrough Devices.
Google PODCAST of TCET
This is an open link to an AI podcast with two AI voices It runs 15 minutes. It's open access but may require Googe login.
AUDIO:
https://notebooklm.google.com/notebook/438d7289-547d-44a3-9ebf-5aee19755dff/audio
Crude Auto Text of Google PODCAST OF TCET
https://brucedocumentblog.blogspot.com/2024/10/tcet-ai-podcast-by-google-notebook-lm.html
