CMS and FDA Launch ACCESS and TEMPO Pilots to Enhance Tech-Enabled Chronic Care for Medicare

CMS and the FDA have introduced coordinated initiatives aimed at expanding technology-enabled care access for Medicare beneficiaries with specific chronic conditions. The CMS announced the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, a decade-long pilot test focusing on an outcomes-based payment system to support technology-enabled healthcare. Digital health tools such as telehealth platforms, wearable devices, and lifestyle coaching applications are pivotal in this effort, addressing existing gaps in Medicare fee-for-service payment models that inadequately accommodate novel digital healthcare solutions. Complementing CMS's approach, the FDA launched the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. TEMPO aligns with the digital health advancement pace and encourages patient access to innovative medical devices. The FDA pilot allows manufacturers providing devices for the ACCESS Model to seek enforcement discretion concerning premarket authorization requirements, expediting access while gathering real-world data to support future FDA marketing approvals. The ACCESS Model encourages organizations to deliver integrated, technology-supported care tailored to patient outcomes rather than specific services. This flexibility is intended to enhance chronic condition management through monitoring condition-specific metrics and outcome targets. CMS will tie payments to the degree of success in meeting these targets. The model also promotes collaboration by enabling referring providers to co-manage patient care with ACCESS participants, with billing options for co-management services without patient cost-sharing. Organizations participating in ACCESS must enroll as Medicare Part B providers or suppliers, appoint clinical directors for oversight, and comply with federal and state regulations, including FDA device requirements or applicable enforcement discretion for devices under the TEMPO pilot. The program focuses on four chronic condition tracks, with safe harbor provisions to reduce financial barriers for beneficiaries and encourage engagement. The FDA's TEMPO pilot will select roughly ten manufacturers per chronic condition track, facilitating controlled use of devices within the ACCESS Model context. Patients involved must be informed and consent to the device's pilot status and data sharing with the FDA. Expressions of interest for participation in TEMPO begin January 2026, with CMS applications for ACCESS due April 1, 2026. Both agencies aim to collect data that may inform future regulatory and reimbursement frameworks. This collaboration represents a significant regulatory effort to modernize Medicare chronic care through digital solutions, signaling shifts in payment models and device authorization processes. The approach integrates clinical innovation, data analytics, and regulatory flexibility to potentially improve patient outcomes and healthcare delivery efficiency. Industry stakeholders, including digital health companies, manufacturers, and care providers, will need to navigate evolving compliance and reimbursement policies under this new framework. Additional resources and guidance materials, including FAQs and implementation details, are being made available by CMS and the FDA to support prospective applicants and manufacturers. The pilot programs highlight the evolving intersection of healthcare technology, regulatory compliance, and value-based care in the Medicare landscape.