What's Happening?
The U.S. Food and Drug Administration (FDA) has introduced a new pilot program called Technology-Enabled Meaningful Patient Outcomes (TEMPO) aimed at integrating digital health devices into the Medicare program. This initiative, in collaboration with
the Centers for Medicare and Medicaid Services (CMS), seeks to bridge the gap between innovation, regulatory authorization, and insurance coverage. TEMPO allows for the limited, supervised use of digital health devices in real-world settings, focusing on chronic disease management. The program targets four high-burden areas: cardio-kidney-metabolic conditions, musculoskeletal conditions, and behavioral health. The FDA plans to select a small cohort of manufacturers to participate, allowing them to deploy devices, collect real-world data, and work towards FDA marketing submissions. This pilot operates alongside CMS's ACCESS model, which ties payment to patient outcomes, enabling the FDA and CMS to observe device performance in clinical settings.
Why It's Important?
The TEMPO pilot addresses a significant challenge in digital health: the difficulty of obtaining FDA authorization and payer uptake without real-world outcomes data. By allowing limited use of devices under supervision, the program aims to generate the necessary evidence for regulatory and payment decisions. This initiative could accelerate the integration of digital health technologies into routine care, potentially improving patient outcomes and reducing healthcare costs. For digital health companies, TEMPO offers a pathway to demonstrate the efficacy of their products, potentially leading to broader adoption and market access. However, the program is not a guarantee of FDA clearance or payment, as it requires participants to adhere to strict monitoring and risk mitigation plans.
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 review these submissions and issue follow-up information requests by March 2, 2026. CMS's ACCESS model will open applications in early 2026, with a deadline of April 1, 2026, for the first performance period beginning July 1, 2026. Companies should also consider advancing traditional marketing pathways in parallel to ensure progress towards market launch, given the limited slots and uncertainties surrounding the TEMPO program.
Beyond the Headlines
TEMPO represents a strategic effort by the FDA and CMS to align regulatory flexibility with outcome-based payment incentives, potentially transforming how digital health technologies are integrated into healthcare. This approach could set a precedent for future regulatory frameworks, emphasizing real-world evidence and patient outcomes. However, the program's success will depend on its ability to balance innovation with safety and efficacy, ensuring that new technologies meet rigorous standards while addressing healthcare needs.
