CMS, FDA Launch Pilot Programs to Modernize Digital Health for Medicare

The Centers for Medicare and Medicaid Services, along with the Food and Drug Administration, have released pilot programs aimed at modernizing the federal digital health ecosystem and providing better health care through technology. 

CMS’s Advancing Chronic Care with Effective, Scalable Solutions model (ACCESS) and the FDA’s Technology-Enabled Meaningful Patient Outcomes program (TEMPO) will work to update how Medicare recipients navigate their health, a system that “hasn’t changed much in decades,” according to CMS Administrator Dr. Mehmet Oz. 

“People increasingly expect technology to help them take charge of their health, whether that’s texting with their doctor, checking blood pressure from home or using an app to track steps, or meals or sleep,” he said.“Technology can transform health care from something that happens in a doctor’s office into something that is always within reach.” 

Abe Sutton, CMS director of Medicare and Medicaid Innovation, said people with Original Medicare haven’t traditionally had access to technology-supported care because Medicare “hasn’t done a good job of paying for it.” The new program, which launches in July 2026, expands care and establishes a result-driven payment method. 

The ACCESS Model

The ACCESS model targets high-prevalence chronic conditions including high blood pressure, diabetes, musculoskeletal pain and depression, among others. 

The program will test Outcome-Aligned Payments (OAPs) with Medicare-enrolled care organizations. Participating organizations will receive recurring payments for managing patients’ qualifying conditions, but a full payment will be based on measurable patient outcomes. The goal is for CMS to reward outcomes, rather than just services provided.  

Organizations that participate in ACCESS are expected to offer in-person or virtual care that includes consultation, lifestyle and behavioral support, therapy and counseling, medication management and ordering and interpreting diagnostic tests and imaging. Additionally, organizations should use or monitor FDA-authorized devices. 

Participating organizations are required to enroll in Medicare Part B as providers and supplies and must appoint a clinical director to conduct oversight.   

The TEMPO Pilot 

The FDA’s TEMPO for Digital Health Devices pilot is aimed at promoting access to digital health devices, according to a policy published last week. Companies accepted into the program can ask the FDA to waive premarket authorization and investigational device requirements in order to participate in the ACCESS model. Manufacturers will instead collect and share real-world data demonstrating the device’s performance. 

“Digital health technologies are rapidly transforming how people manage chronic conditions, and we want to ensure our regulatory approach keeps pace,” said Center for Devices and Radiological Health Director Michelle Tarver. “The TEMPO pilot will allow us to responsibly encourage innovation while collecting real-world evidence that may help us better understand how these devices perform for patients in their everyday lives.” 

What’s Next 

The FDA anticipates selecting 10 device manufacturers for each of the ACCESS program’s four areas of interest: early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal and behavioral health.  

Companies interested in participating in the pilot can submit statements of interest beginning Jan. 2. As part of the application, companies should provide information on safety data, risk-mitigation plans and timelines for submitting a formal marketing submission. The ACCESS program is set to start on July 1 and run for 10 years.