What's Happening?
The U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have introduced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program. This initiative aims to facilitate the integration of digital
health devices into the Medicare program by allowing limited, supervised real-world use of these devices. The pilot targets chronic disease management in areas such as cardio-kidney-metabolic conditions, musculoskeletal conditions, and behavioral health. The program seeks to bridge the gap between innovation, evidence development, regulatory authorization, and insurance coverage.
Why It's Important?
The TEMPO pilot represents a significant step towards modernizing healthcare delivery by integrating digital health technologies into routine care. By aligning regulatory flexibility with outcome-based payment incentives, the program could accelerate the adoption of innovative health solutions, potentially improving patient outcomes and reducing healthcare costs. The initiative also addresses the challenge of obtaining FDA authorization and payer uptake without real-world outcomes data, offering a pathway for digital health companies to demonstrate the efficacy of their products in clinical settings.
What's Next?
Digital health companies interested in participating in the TEMPO pilot should prepare to submit statements of interest starting January 2, 2026. The FDA will issue follow-up information requests by March 2, 2026, with the CMS ACCESS model opening applications in early 2026. Companies should also consider advancing traditional marketing pathways in parallel to ensure progress towards market launch, given the limited number of available slots and remaining uncertainties in the program.
