For medical device manufacturers, securing Medicare coverage is a critical milestone, yet navigating the complexities of the coverage determination process has long been a challenge. With the introduction of Medicare’s Transitional Coverage for Emerging Technologies (TCET) policy, there’s now a more structured and predictable pathway for breakthrough devices to gain expedited coverage. However, successfully leveraging the TCET policy requires a deep understanding of its requirements, along with strategic planning and engagement with the Centers for Medicare & Medicaid Services (CMS).
What Is the TCET Policy?
The TCET policy was developed to address the unique challenges that emerging medical technologies face in gaining Medicare coverage. Traditionally, new medical devices, particularly those targeting Medicare beneficiaries, struggled to secure coverage due to stringent evidentiary requirements, complex processes, and the high cost of gathering clinical evidence.
With TCET, CMS aims to accelerate access to breakthrough technologies for Medicare beneficiaries while ensuring that the necessary clinical evidence is generated to support long-term coverage decisions. FDA-designated Breakthrough Devices are eligible for this pathway, which allows for earlier coverage decisions, provided certain conditions and evidence generation milestones are met.
Key Features of the TCET Pathway
1. Early Engagement and Proactive Planning
One of the key benefits of the TCET pathway is the opportunity for early and ongoing engagement with CMS. This allows manufacturers to align their development and evidence-generation plans with CMS’s expectations well before they submit a formal coverage application. Early engagement can help you refine your strategy, avoid potential pitfalls, and ensure you’re on the right track.
2. Streamlined Coverage Process
The TCET pathway offers a more transparent and predictable process for Medicare coverage determinations. Manufacturers can submit a non-binding Letter of Intent to CMS up to 18-24 months before anticipated FDA marketing authorization. This provides time for CMS to review the device’s potential impact on Medicare beneficiaries and to provide feedback on the evidence development strategy.
3. Evidence Development Framework
One of the most critical elements of the TCET policy is its emphasis on evidence generation. Devices accepted into the TCET pathway are expected to meet rigorous evidence standards, including the development of an Evidence Development Plan (EDP) to address any gaps in existing data. The EDP can incorporate both clinical trial data and real-world evidence, providing a comprehensive understanding of how the device performs in real-world settings.
CMS collaborates with the Agency for Healthcare Research and Quality (AHRQ) to evaluate the EDP and ensure it meets the scientific standards needed to support Medicare coverage decisions.
4. Duration of Transitional Coverage
Coverage under the TCET policy is not indefinite. It’s tied to the timeline specified in the EDP for evidence generation, with additional time allowed for manufacturers to complete their analysis and submit for peer-reviewed publication. CMS anticipates that the total coverage duration under TCET could last up to five years or more. After this period, a review process is initiated to determine whether the device will receive long-term coverage or whether coverage will be modified, extended, or discontinued.
Benefits and Risks of the TCET Pathway
The TCET policy offers significant benefits for medical device developers, including faster access to the Medicare market, a structured coverage process, and the potential to leverage high-quality evidence for broader reimbursement opportunities with commercial payers. However, there are risks as well. The policy places a heavy emphasis on evidence generation, and failure to meet CMS’s rigorous standards could result in delayed or denied coverage. Additionally, manufacturers must be prepared for the public scrutiny that comes with the transparency requirements of the TCET process.
Positioning Your Medical Device for Success
To successfully navigate the TCET process, device manufacturers need to be proactive in several key areas:
•Understand TCET eligibility criteria: Ensure your device qualifies under the FDA’s Breakthrough Device designation and falls within a Medicare benefit category.
•Align your evidence development strategy with CMS’s expectations: Engage early with CMS to develop a robust Evidence Development Plan that addresses any gaps in your clinical or real-world data.
•Prepare for public transparency: Be ready for non-proprietary elements of your EDP to be made publicly available. Having a solid evidence generation plan can help your device withstand public scrutiny.
By carefully aligning your strategy with the requirements of the TCET pathway, you can position your medical device for expedited Medicare coverage and long-term market success.
Ready to Dive Deeper?
For a more detailed analysis of the TCET policy, including actionable strategies for navigating the coverage process, download our comprehensive white paper. This guide walks you through every step, from meeting eligibility criteria to developing an effective evidence generation plan.
👉 Click below to download the full white paper and learn how to leverage TCET to bring your breakthrough medical device to market faster!
Download your own copy of the TCET policy from CMS itself here!
How Can We Help?
At Gettysburg Healthcare Consulting, our team of Medicare and Medicaid policy pros are dedicated to helping you navigate the complex landscape of diagnostic, pharmaceutical and medical device coverage. With our expertise and insider knowledge, we ensure your molecular diagnostic test receives the necessary coverage, allowing you to generate income quickly. Trust our reliable and honest approach to healthcare consulting, and let us guide you towards success. Schedule a meeting now!