CMS and FDA Launch ACCESS and TEMPO Programs to Promote Outcome-Based Chronic Care

The Centers for Medicare & Medicaid Services (CMS) Innovation Center is launching the "Advancing Chronic Care with Effective Scalable Solutions" (ACCESS) model, a decade-long demonstration project starting in April 2026. This model shifts Medicare reimbursement from traditional fee-for-service payments to a value-based system where payments are tied to patient health outcomes rather than service volume. It targets organizations managing chronic diseases such as obesity, diabetes, musculoskeletal pain, and depression, especially those leveraging technology-enabled services alongside standard care. Complementing ACCESS, the Food and Drug Administration (FDA) introduced the "Technology-Enabled Meaningful Patient Outcomes" (TEMPO) pilot program on December 8, 2025. TEMPO facilitates the use of digital health technologies by offering a risk-based, voluntary regulatory path for up to 40 companies developing tools in cardio-kidney-metabolic conditions, musculoskeletal pain, and behavioral health. Participating entities benefit from FDA enforcement discretion on certain premarket requirements in exchange for collecting and reporting real-world performance data. Both programs have streamlined application processes, with ACCESS requiring Medicare Part B enrollment, a medical director to oversee compliance, and adherence to federal and state healthcare regulations including HIPAA, privacy, and FDA rules. TEMPO applicants need to submit a Statement of Interest followed by detailed documentation and are encouraged to engage in focused discussions with the FDA. Although participating in either ACCESS or TEMPO is independent, the FDA anticipates that products from the TEMPO pilot will complement the ACCESS model for reimbursement eligibility. For digital health companies and healthcare providers, these initiatives present opportunities to commercialize and integrate technology-enabled services under regulatory and payment models designed to emphasize patient outcomes. The programs encourage strategic regulatory planning around product development, real-world data collection, and healthcare compliance. New and emerging companies may find TEMPO especially attractive due to the capacity to launch technologies without awaiting full FDA marketing authorization. Prospective participants are advised to evaluate both programs carefully, considering commercialization objectives, technology readiness, and compliance challenges. Legal advisory firms specializing in life sciences and healthcare regulatory matters are positioned to support stakeholders in navigating these innovative frameworks, ensuring adherence to enforcement policies and optimizing market entry. This transition represents a broader industry shift toward outcome-oriented care models supported by digital health innovation, signaling evolving regulatory and reimbursement environments essential to chronic disease management strategies in U.S. healthcare.