FDA Launches Pilot Program for Digital Health Devices to Access Medicare Payment
The Food and Drug Administration (FDA) has introduced a new pilot program that allows digital health devices to access a Medicare payment option through the Centers for Medicare and Medicaid Services (CMS). This initiative, known as the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, aims to facilitate the collection of real-world data by waiving certain premarket authorization and investigational device requirements. The CMS program, called Advancing Chronic Care with Effective, Scalable Solutions (ACCESS), is designed to address barriers in care due to Medicare’s fee-for-service model. It will provide recurring payments to healthcare sites managing patients with qualifying conditions, contingent on achieving measurable health outcomes. The FDA plans to accept up to 10 U.S.-based manufacturers in each of four focus areas: early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal, and behavioral health. 
