CMS and FDA Launch Digital Health Models to Transform Medicare Care Delivery

On December 11, 2025, CMS Innovation Center and FDA announced two complementary models: ACCESS and TEMPO, aimed at integrating digital health technologies into Medicare to improve chronic condition management and health outcomes. ACCESS is a voluntary 10-year CMS Innovation Center model targeting traditional Medicare (Part B) beneficiaries. It focuses on enhancing care delivery across four clinical tracks using digital health tools, requiring participants to be enrolled Medicare Part B providers or suppliers, and emphasizing tech-enabled, integrated care. The model introduces outcome-aligned payments (OAPs) linked to measurable health results, with specific provisions for rural patient populations and options for continuing care beyond an initial year. Primary care providers retain a supportive role, able to refer patients and bill co-management fees, while beneficiaries can self-enroll with participating providers listed in a CMS directory. TEMPO, a partnership initiative under the FDA's Home as a Health Care Hub, functions as a regulatory sandbox allowing selected manufacturers of non-FDA-authorized digital health devices to pilot their use within ACCESS. This pilot eases certain regulatory constraints, permitting enforcement discretion on premarket authorizations and investigational device exemptions during the pilot, in exchange for real-world evidence collection to support future marketing approvals. Participation will be capped at around 10 devices per clinical area, with safety risk assessments influencing selection. The CMS request for applications for ACCESS is expected soon, with participation announcements starting in mid-2026. The FDA will begin accepting TEMPO statements of interest in January 2026. Key areas needing clarification include how OAPs will interact with existing value-based care frameworks such as ACOs, particularly since beneficiaries may self-refer, potentially complicating care coordination. CMS has indicated OAP inclusion in ACO benchmarks beginning 2028, following a two-year reprieve. CMS hinted at multi-payer alignment goals, noting that OAPs could be recognized within Medicare Advantage medical loss ratios and suggesting that states could allow Medicaid managed care to adopt similar models via ‘in lieu of services’ authorities. This signals a potential broadening of the approach beyond traditional Medicare. Patient protections, including cybersecurity and privacy, are central to both models. CMS anticipates growth in participating organizations and clinical tracks as digital health ecosystems mature. Initial industry interest reported by CMS and FDA is strong, but actual engagement will clarify the models' practical impact. The models represent strategic opportunities for providers and digital device companies, with implications for regulatory compliance, payer/provider reimbursement, and care delivery innovation in U.S. Medicare programs.