The Centers for Medicare & Medicaid Services (CMS) issued a proposed procedural notice outlining a new Medicare coverage pathway to achieve more timely and predictable access to new medical technologies for people with Medicare. The new Transitional Coverage for Emerging Technologies (TCET) pathway for Breakthrough Devices supports both improved patient care and innovation by providing a clear, transparent, and consistent coverage process while maintaining robust safeguards for the Medicare population.
The TCET pathway uses current national coverage determination (NCD) and coverage with evidence development (CED) processes to expedite Medicare coverage of certain breakthrough devices.
TCET is voluntary and aims to reduce uncertainty about coverage options through a premarket evaluation of potential harms and benefits of technologies while identifying any important evidence gaps. Additionally, the TCET pathway includes an evidence development framework that provides manufacturers with opportunities for increased premarket engagement with CMS and, in an effort to reduce manufacturer burden, an unprecedented level of flexibility to address evidence gaps to support Medicare coverage. Specifically, TCET allows for any evidence gaps to be addressed through fit-for-purpose studies. A fit-for-purpose study is one in which the study design, analysis plan, and study data are appropriate for the question the study aims to answer. Further, the TCET pathway will help coordinate benefit category determination, coding, and payment reviews.
Given the unique criteria for breakthrough designation status by the US Food and Drug Administration (FDA), the TCET pathway will apply to certain eligible FDA-designated breakthrough devices because this is the area with the most immediate need for a pathway like TCET.
Appropriate candidates for the TCET pathway would include those devices that are:
- Certain FDA-designated breakthrough devices;
- Determined to be within a Medicare benefit category;
- Not already the subject of an existing Medicare NCD; and
- Not otherwise excluded from coverage through law or regulation.
When developing the pathway, CMS solicited extensive feedback from patient groups, medical professionals, device manufacturers, innovators, and other federal agencies. This feedback included requests for CMS to utilize a more agile, iterative evidence review process that considers fit-for-purpose study designs, including those that make secondary use of real-world data. CMS partnered with the Agency for Healthcare Research and Quality to develop a comprehensive approach that incorporates greater flexibility into the proposed CED paradigm and allows fit-for-purpose study designs. CMS will continue to engage with these stakeholders to ensure that Medicare promotes access to emerging medical technologies while maintaining appropriate safeguards and rigorous evidence standards essential to the health of Medicare beneficiaries.
The public will have 60 days to provide comments on the procedural notice. CMS will respond to public comments in a subsequent final notice. The 60 days will begin after publication to the Federal Register, which is planned for June 27.
To read the announcement, visit the CMS website.
To read the unpublished version of the proposed procedural notice, visit the Federal Register.
