The Centers for Medicare & Medicaid Services (CMS) have announced a significant transformation in their approach to coverage reviews and evidence development. This transformation is part of CMS commitment to encouraging innovation while providing consistent and quick access to emerging technologies for Medicare beneficiaries. The proposed change is known as the Transitional Coverage for Emerging Technologies (TCET) pathway.
What does the TCET Pathway entail?
The TCET pathway is a new expedited route for Medicare coverage. Voluntary in nature, the TCET pathway is designed specifically to support specific FDA-designated Breakthrough Devices. As such, the pathway aims to provide an effective, predictable, and transparent coverage review process while developing robust safeguards for the Medicare beneficiaries.
The TCET pathway offers manufacturers several benefits. This includes opportunities for enhanced engagement with CMS before market launch and an unprecedented level of flexibility to address any evidence gaps related to coverage.
The ultimate goal of the TCET pathway is twofold. Firstly, to develop robust evidence to assist patients and physicians in making informed healthcare decisions. Secondly, to ensure that Medicare beneficiaries receive high-quality care.
The Role of Coverage with Evidence Development (CED) in TCET
The TCET pathway leverages coverage with evidence development processes to expedite Medicare coverage of Breakthrough Devices. The pathway aims to resolve uncertainties regarding coverage options through a pre-market evaluation of the potential risks and benefits of technologies. This also helps in identifying significant evidence gaps.
The TCET pathway also assists in coordinating benefit category determination, coding, and payment reviews. Lastly, the pathway allows manufacturers to plug any evidence gaps using fit-for-purpose studies.
What is a Fit-for-Purpose Study?
A fit-for-purpose study is one where the design, analysis plan, and study data are all aligned perfectly with the objective of the study. In many cases, these studies may leverage data already collected through routine care delivery.
Key Features of the TCET Pathway
- TCET is applicable to certain FDA-designated Breakthrough Devices that fit within a Medicare benefit category.
- Manufacturer participation in the TCET pathway is voluntary.
- CMS may conduct an early evidence review (Evidence Preview) before FDA approves the marketing authorization for the device.
- For Breakthrough Devices in the TCET pathway, CMS aims to finalize a TCET NCD within six months after the FDA market authorization.
Stakeholder Involvement in TCET development
During the development of the TCET pathway and the new evidence development framework, CMS took into account extensive feedback from numerous stakeholders. This includes patient groups, medical professionals, device manufacturers, innovators, and other Federal agencies. Thereby, ensuring that Medicare promotes access to emerging medical technologies while upholding rigorous evidence standards crucial to Medicare beneficiaries.
TCET Procedural Notice Public Review
CMS issued a procedural notice outlining newly proposed criteria, which will be open for public review for 60 days. This includes an updated Coverage with Evidence Development guidance document and new guidance documents that review health outcomes and their clinically meaningful differences. CMS is expected to further publish more detailed fit-for-purpose guidance later this year.
With the TCET procedural notice and guidance documents, CMS is further reinforcing its commitment to making evidence-based healthcare accessible to its beneficiaries, thereby ensuring better health outcomes.
_For more details about the TCET Pathway, visit
Tags: #MedicareCoverage #TCET #EmergingTechnologies #HealthCareInnovation