Pathways' Pick of the Week: CMS Seeks Diabetes Device Endpoints Guidance

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CMS aims to identify diabetes endpoints. Excerpted from Pathways' Picks March 27: Dx Debate, Medicare Diabetes Endpoints, EU Expert Panels, and Global Picks.

CMS has scheduled an advisory panel meeting in May to identify appropriate clinical endpoints to support Medicare coverage of new devices for self-management of type 1 and insulin-dependent type 2 diabetes. The May 21 Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting is the first to be convened under CMS’ recently established Clinical Endpoints Guidance program.

The endpoints program was unveiled in conjunction with CMS’ June 2023 Transitional Coverage of Emerging Technologies proposal for streamlining Medicare coverage of FDA Breakthrough Devices. The agency will for the first time issue guidelines detailing outcome measures relevant for older populations in specific clinical areas. Data on those endpoints would be needed to support coverage and to serve as the basis for “coverage with evidence development” conditions for TCET or traditional national coverage determination policies.

In May, CMS will present an agency-commissioned clinical endpoints review for diabetes devices, including continuous glucose monitoring and closed-loop insulin delivery systems, for the MEDPAC panel to consider. They will weigh in on outcome measures that might not be captured in FDA studies but are necessary for the Medicare population. “Studies of devices submitted through the Food & Drug Administration’s Breakthrough Technology pathway have often focused on shorter term data with greater reliance upon intermediate and surrogate outcomes,” CMS states in announcing the May meeting. “Although these endpoints may help in answering FDA questions on safety and efficacy, they are generally less helpful for CMS whose focus is on the more ultimate health outcomes associated with the technologies, and particularly for older adults.” 

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