CMS and FDA Launch Models to Integrate Digital Health in Traditional Medicare

The Centers for Medicare & Medicaid Services (CMS) Innovation Center and the U.S. Food and Drug Administration (FDA) have introduced two coordinated models, ACCESS and TEMPO, aiming to expand the integration of digital health technologies in traditional Medicare. ACCESS is a voluntary, 10-year initiative designed to modernize Medicare Part B by incorporating digital devices and tech-enabled care to improve outcomes in four clinical tracks. Participating providers must be enrolled in Medicare Part B, excluding certain suppliers, and will receive outcome-aligned payments tied to measurable health improvements, with additional rural patient adjustments to enhance access in underserved areas. Primary care providers will play a supportive role through patient referrals and a new co-management billing code, while Medicare beneficiaries will have direct access to participating organizations through a CMS-maintained directory. TEMPO functions as a regulatory sandbox under the FDA's Home as a Health Care Hub initiative, allowing selected non-FDA-authorized digital health devices to be piloted within ACCESS. This pilot facilitates real-world data collection to expedite regulatory approval processes by exercising enforcement discretion over certain device requirements during the trial period. TEMPO participation is limited to about ten devices per clinical track, focusing on those that do not present serious safety risks. While CMS and FDA have outlined key features of ACCESS and TEMPO, details such as interactions with existing value-based care models, especially Accountable Care Organizations (ACOs), remain to be clarified. CMS plans a two-year reprieve for ACOs on outcome-aligned payments (OAPs), after which OAPs will be included in ACO benchmark calculations, raising questions about managing potential care fragmentation given patient self-referrals. Additionally, CMS signaled a broader long-term strategy for multi-payer alignment, including potential adoption of ACCESS-like payment structures in Medicaid managed care under state ‘‘in lieu of services’’ provisions, and consideration of Medicare Advantage medical loss ratio treatments. Patient protection elements, including cybersecurity and privacy, are prioritized in both models, with CMS and FDA anticipating growth in participating organizations and coverage areas as digital health technology adoption expands. The agencies expect open applications for ACCESS to begin in early 2026, with CMS and FDA already seeing significant interest in these innovation efforts from stakeholders across the healthcare ecosystem.