The proposed Transitional Coverage for Emerging Technologies (TCET) pathway is designed to facilitate Medicare coverage for new treatments that usually need time to develop data proving their value.
Federal officials are proposing an expedited pathway for Medicare coverage of new medical technologies.
In a notice posted in the Federal Register, the Centers for Medicare & Medicaid Services (CMS) is proposing a voluntary Transitional Coverage for Emerging Technologies (TCET) pathway for designated Breakthrough Devices. Officials say the new pathway, developed in a partnership with the Agency for Healthcare Research and Quality (AHRQ), should speed up the process to bring new treatments to Medicare beneficiaries while ensuring those treatments still meet rigorous review guidelines.
"As part of our commitment to fostering innovation and ensuring patient-centered care, CMS created the TCET pathway to provide a mechanism for coverage for certain new, innovative technologies with limited or developing evidence in the Medicare population using a transparent and predictable evidence generation framework that, when appropriate, not only develops reliable evidence for patients and their physicians to make healthcare decisions but also provides safeguards to ensure that Medicare beneficiaries are protected and continue to receive high-quality care," the agency said in a press release.
Officials said the new pathway was developed through feedback from a wide range of sources and based on 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."
Candidates for the TCET pathway will include 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.
Key elements to the TCET pathway include an evidence preview, or focused literature review, and an evidence development plan (EDP), which would be drafted by the developer to address any evidence gaps spotted in the evidence preview.
Once a treatment has qualified for this pathway, Medicare coverage will remain in place "only as long as needed to facilitate the timely generation of evidence that can inform patient and clinician decision making," along with an additional year to allow manufacturers to finish their analysis. CMS would then launch its updated evidence review.
Public comments on the proposal will be accepted for the next two months.
Eric Wicklund is the associate content manager and senior editor for Innovation, Technology, Telehealth, Supply Chain and Pharma for HealthLeaders.
Innovative new technologies and treatments often take a lot of time in the CMS review portal because they haven't accrued enough real-world data to prove their value.
This new pathway, developed in a partnership with the AHRQ, would give select new devices a quicker pathway to Medicare coverage while they're gathering the data necessary for a full review.
The pathway "not only develops reliable evidence for patients and their physicians to make healthcare decisions but also provides safeguards to ensure that Medicare beneficiaries are protected and continue to receive high-quality care."