FDA and CMS Pilot Programs Aim to Expand Digital Health Access for Medicare

On December 8, 2025, the FDA announced the launch of the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, designed to complement the Center for Medicare and Medical Innovation’s (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) payment model. CMMI's ACCESS model aims to promote outcome-aligned payments (OAPs) that enhance access to digital health technologies for Medicare beneficiaries managing chronic conditions such as diabetes, hypertension, depression, and chronic musculoskeletal pain. This model ties payments to measurable clinical improvements, addressing longstanding reimbursement challenges for digital health tools like telehealth software, wearables, and coaching apps. The TEMPO pilot offers participating manufacturers, limited to ten, the opportunity to request FDA enforcement discretion, potentially exempting them from certain regulatory requirements such as premarket authorization and investigational device exemptions. FDA's involvement focuses on facilitating real-world data collection from devices used in the ACCESS model to generate evidence on benefit-risk profiles, which may inform future FDA authorization decisions. While the TEMPO pilot provides a framework for increased regulatory flexibility, its limited scale and lack of detailed benefits suggest its immediate impact on the FDA regulatory process will be modest. In contrast, the ACCESS payment model represents a significant innovation in Medicare’s approach by financially incentivizing health outcome improvements through digital health technologies. The collaboration between FDA and CMS underscores a federal-level recognition of the need to bridge access gaps in digital health for chronic disease management. Though the TEMPO pilot's direct advantages to device manufacturers might be limited, the partnership signals a strategic move towards integrating regulatory and reimbursement pathways that could influence the future landscape of digital health innovation. Industry stakeholders are advised to monitor these pilots closely, as the evolving regulatory and payment frameworks may set precedents for expedited access and evidence generation for digital health technologies. The outcomes could shape reimbursement policies, accelerate technology adoption, and redefine compliance considerations within the Medicare program.