CMS Digital Therapeutics Coverage Model for Chronic Care Devices

The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services Innovation Center have launched a joint evaluation process under the CMS Digital Therapeutics Coverage Model that links regulatory review with payment pathways for digital health devices addressing chronic conditions in Medicare populations.

Joint FDA-CMS Device Evaluation Pathway

The announcement establishes a coordinated mechanism through which the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services Innovation Center jointly evaluate digital health devices for eventual coverage under the Advancing Chronic Care with Effective, Scalable Solutions model. This linkage creates a structured route for manufacturers to demonstrate that their technologies can support measurable health improvements in chronic disease populations eligible for Medicare. The selection of Dexcom, Inc., as the initial participant signals the operational start of this pathway for metabolic monitoring tools.

Real-World Data Requirements for Model Participation

Participating manufacturers must implement systematic collection, monitoring, and reporting of real-world data tied directly to each device’s stated clinical applications within the Advancing Chronic Care with Effective, Scalable Solutions framework. Selection decisions rest on assessments of potential patient risks, anticipated clinical benefit, data collection plans, and consistency with predefined outcome measures in the CMS Digital Therapeutics Coverage Model. Up to approximately ten manufacturers may be chosen per clinical use area across four targeted domains, with preference given to U.S.-based entities that align with goals of access, safety, and evidence quality.

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Dexcom Program Targets Prediabetes and Glycemic Control

Dexcom’s Glucose Health Program supplies continuous metabolic and nutritional metrics, personalized recommendations, and artificial intelligence-derived insights intended to aid patients and clinicians in behavioral adjustments. The program targets two specific use areas under the model: screening for prediabetes and type 2 diabetes via integrated digital metrics, and support for glycemic improvement and reduced hemoglobin A1c levels among individuals with prediabetes. This configuration allows real-world performance data to be generated whether the device is supplied directly by the manufacturer or through another participating organization in the model.

Outcome-Linked Payment for Chronic Care Technologies

The pilot supplies a mechanism for linking measurable patient outcome improvements to payment under the Advancing Chronic Care with Effective, Scalable Solutions model rather than traditional fee-for-service structures. By generating real-world data on device performance in routine settings, the effort informs both regulatory and coverage decisions for technologies addressing cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions. Ongoing acceptance of statements of interest without a fixed deadline enables continued expansion of the evidence base needed to scale such tools responsibly within Medicare populations.