WASHINGTON, D.C. — The Food and Drug Administration selected Dexcom Inc. as the first participant in a federal pilot linking digital health-device oversight with a Medicare payment model that rewards measurable improvements in chronic disease outcomes.
Dexcom’s Glucose Health Program will be evaluated through the FDA’s Technology-Enabled Meaningful Patient Outcomes, or TEMPO, pilot while being positioned for use under the Centers for Medicare & Medicaid Services Innovation Center’s ACCESS model.
The initiative creates a pathway for manufacturers to generate real-world evidence on digital health technologies while those products are used in care arrangements serving Medicare patients.
ACCESS, which began its first cohort in July 2026, bases payment on patient health improvements rather than individual services. The model covers technology-supported care for certain cardio-kidney-metabolic, musculoskeletal and behavioral health conditions.
“The first TEMPO participant represents an important step toward modernizing how innovative technologies reach people with Medicare,” CMS Innovation Center Director Abe Sutton stated.
Dexcom’s program is intended to help patients, health professionals and caregivers monitor metabolic and nutritional measures, receive tailored guidance and review real-time data and artificial intelligence-generated insights.
The program is also intended to assist in screening for prediabetes and type 2 diabetes through integrated digital health measures. The FDA said it may contribute to improved glycemic control and lower HbA1c levels among people with prediabetes.
Those intended uses remain under FDA evaluation during the pilot.
Participating manufacturers must collect, monitor and report real-world data showing how their devices perform and whether they improve patient outcomes. The information will be used by the FDA and CMS to assess safety, effectiveness and potential patient benefit outside traditional clinical studies.
TEMPO is designed to accommodate the rapid development and updating of digital health products while maintaining federal oversight of patient risks.
“The selection of our first TEMPO participant marks a meaningful milestone as we pilot an approach, in partnership with the CMS Innovation Center, to meet patients where they are and generate the real-world evidence needed to ensure these technologies truly deliver for them,” FDA device center Director Michelle Tarver stated.
The FDA plans to select as many as about 10 manufacturers in each of four ACCESS clinical-use categories. Selection considerations include potential patient risks, expected benefits and the strength of manufacturers’ plans for collecting and reporting real-world data.
Devices may be offered directly by their manufacturers participating in ACCESS or through another organization enrolled in the Medicare model.
The FDA continues to accept statements of interest for TEMPO and has not established a deadline for submissions.
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