CMS and FDA Launch ACCESS and TEMPO to Expand Tech-Enabled Medicare Care

CMS and the FDA have jointly introduced initiatives aimed at enhancing access to technology-supported care for Medicare beneficiaries with chronic conditions. The Centers for Medicare & Medicaid Services (CMS) launched the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, a decade-long pilot program focusing on an outcomes-based payment system to facilitate technology-enabled care within Medicare. This model targets improved patient outcomes through tools such as telehealth applications, wearable devices, and coaching platforms that support continuous disease management outside traditional medical settings. Simultaneously, the Food and Drug Administration (FDA) initiated the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot. TEMPO complements the ACCESS Model by allowing certain digital health device manufacturers to request enforcement discretion, enabling use of innovative devices within ACCESS participants without prior FDA market authorization. This approach encourages real-world data collection to potentially support future regulatory approvals while expanding patient access to emerging technologies. ACCESS participants are required to be Medicare Part B enrolled providers or suppliers who integrate technology into coordinated care strategies overseen by appointed clinical directors. The model places emphasis on patient-specific outcome measures, providing flexibility in care delivery and incentivizing providers through outcome-aligned payments. Referring physicians can continue to engage with patients via co-management billing provisions that strengthen collaboration between conventional care and technology-based services. The ACCESS Model focuses on four chronic condition tracks, though specific conditions were not detailed in the announcement. CMS offers safe harbor protections to participating organizations that opt not to impose cost-sharing on patients, aiming to maximize beneficiary engagement. Device use under the TEMPO pilot requires informed patient consent, including disclosure of participation in FDA's enforcement discretion pilot and data sharing policies. Applications for ACCESS participation are due by April 2026, with FDA seeking manufacturer candidates starting January 2026. These coordinated programs represent a regulatory and payment strategy shift designed to integrate digital health innovations within Medicare, potentially influencing future care standards and reimbursement frameworks for chronic disease management.