What's Happening?
The FDA, in collaboration with the Centers for Medicare and Medicaid Services (CMS), has introduced the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot (TEMPO). This initiative aims to test the real-world use of digital
health devices in the Medicare program, focusing on chronic disease management. TEMPO allows limited, clinician-supervised use of devices in outpatient and home-based care, with a focus on cardio-kidney-metabolic conditions, musculoskeletal conditions, and behavioral health. The pilot seeks to generate real-world evidence to support future FDA marketing submissions and align with CMS's outcome-based payment model.
Why It's Important?
TEMPO addresses the challenge of obtaining FDA authorization and payer uptake for digital health technologies by facilitating real-world evidence generation. This pilot could accelerate the integration of digital health devices into clinical practice, potentially improving patient outcomes and reducing healthcare costs. By aligning regulatory flexibility with payment incentives, TEMPO aims to bridge the gap between innovation and evidence, encouraging the adoption of new technologies in healthcare. The initiative reflects a broader effort to modernize healthcare delivery and enhance chronic disease management through technology.
What's Next?
Digital health companies interested in participating in TEMPO can submit statements of interest starting January 2, 2026. The FDA will select a small cohort of manufacturers to participate, with CMS's ACCESS model opening applications in early 2026. Companies should prepare to generate real-world evidence and work towards FDA marketing submissions. The pilot's success could influence future regulatory and payment policies, potentially expanding the use of digital health devices in Medicare and beyond.
