CMS Finalizes Medicare Payment Rate for Cardio Diagnostics' AI-Driven CHD Tests

Cardio Diagnostics Holdings Inc., an AI-driven cardiovascular diagnostics company, announced a final gapfill payment rate of $854 from the Centers for Medicare and Medicaid Services (CMS) for its AI-powered Epi+Gen CHD and PrecisionCHD tests. This payment rate is a substantial increase from the preliminary amounts, set to take effect for claims dated on or after January 1, 2026. The tests analyze both genetic and epigenetic markers to assess coronary heart disease (CHD) risk, enabling non-invasive and scalable cardiovascular risk detection through a simple blood draw. Receiving a final gapfill payment rate is a crucial step toward broader Medicare reimbursement for these diagnostic tools, which have dedicated CPT Proprietary Laboratory Analysis codes effective April 1, 2024. Cardiovascular disease remains the leading cause of death in the U.S., with CHD accounting for over 370,000 deaths in 2022, underscoring the importance of innovative early detection technologies like those developed by Cardio Diagnostics. Cardio Diagnostics’ tests aim to identify CHD risks early, which potentially enables preventive interventions to reduce the incidence of heart attacks and strokes. The company has expanded access to its tests through partnerships with 15 new provider organizations across multiple U.S. regions, representing diverse medical specialties and care models. Additionally, Cardio Diagnostics has collaborated with the YMCA of East Tennessee to develop a heart disease prevention program targeting more than 40,000 members and the broader community, enhancing education on heart disease and offering discounted access to its diagnostic tests. These initiatives position Cardio Diagnostics' tests as integral to evidence-based cardiovascular health management across the country. With the Medicare payment rate finalized for 2026 and ongoing partnerships, Cardio Diagnostics is positioned to enhance accessibility and adoption of advanced cardiovascular diagnostic testing, supporting clinicians and payer/provider networks in managing heart disease risk through innovative AI-driven tools.