The Transitional Coverage for Emerging Technologies Pathway—Enhancing Innovation While Establishing Patient Safeguards

Last year, the Centers for Medicare & Medicaid Services (CMS) committed to ensuring Medicare patients have better access to emerging technologies and outlined principles that would underpin this approach.1 On June 22, 2023, CMS announced that it was seeking public comments on its Transitional Coverage for Emerging Technologies (TCET) pathway, which we believe is a balanced approach that promotes faster access to new technologies by implementing transparent, predictable, and efficient coverage review processes. Simultaneously, it reduces uncertainty about CMS’s evidence expectations for manufacturers seeking national coverage of emerging technologies, thereby promoting innovation.

As part of a broader coverage modernization initiative, TCET focuses on certain US Food and Drug Administration (FDA) devices designated by the Breakthrough Devices Program.2 This program aims to accelerate the development of new medical devices for patients with life-threatening or irreversibly debilitating diseases or conditions that meet particular criteria. Smaller studies using nontraditional study designs and data analysis methods, surrogate outcomes, and real-world evidence may be used to support market authorization of these devices.3 At the time of FDA market authorization, many devices that use these strategies have important evidence gaps relative to the reasonable and necessary legal standard required for Medicare coverage.

For coverage decisions, CMS specifically requires evidence of benefit in the Medicare population, which is often older, has more complex medical needs, and is inadequately represented in clinical studies used to obtain FDA market authorization. The TCET pathway will support coverage for promising new technologies as manufacturers develop additional evidence after the devices enter the market. The pathway also includes safeguards that protect Medicare beneficiaries while promoting high-quality care.