Cleerly Brokers Medicare Coverage for AI-Enabled Coronary Scans

Cleerly has expanded reimbursed coverage of its artificial intelligence-powered technology that assesses coronary artery disease.

Several Medicare Administrative Contractors (MACs) have officially approved AI-enabled Quantitative Coronary Topography (AI-QCT) scans for Medicare recipients with stable and acute symptoms suspicious of coronary artery disease. The coverage takes effect on Nov. 24 in the Palmetto GBA, CGS Administrators, National Government Services (NGS), and WPS administrative groups. In the United States, MACs provide coverage for approximately 34 million Medicare beneficiaries.

Cleerly requested the MAC decision in February 2023. Its AI-QCT technology, Cleerly Labs, provides a comprehensive, standardized and reproducible coronary artery disease assessment based on a noninvasive cardiac computed tomography angiography (CCTA). In several studies comparing it with invasive gold standards, Cleerly Labs has proven to be highly accurate in assessing the presence, extent, and composition of coronary atherosclerotic plaque and similar to consensus readings of Level 3 expert physician readers. The new Medicare coverage will include Cleerly Labs plaque analysis for patients with acute or stable chest pain with no known CAD, and CAD-RADS 1-3.

“We applaud this decision by the MACs to extend coverage for AI-QCT. When we first requested a coverage decision for Cleerly Labs, our goal was to ensure at-risk patients had coverage for the most advanced cardiovascular testing technology that can most effectively guide clinical decision making,” Cleerly Founder/CEO James K. Min, M.D., said. “We are also extremely thankful to the many physicians and medical society partners who used their voices to advocate for this essential AI-QCT technology. Until Cleerly, healthcare providers have not had a way to easily and completely assess the primary cause of heart attacks, atherosclerotic plaque burden and type, in a noninvasive way, which is especially important for our senior population. This decision by the MACs represents a significant step in advancing the field of cardiology, and providing the best possible care for our seniors.”

Cleerly is aiming to eliminate heart attacks by creating a new standard of care for heart disease. Through its U.S. Food and Drug Administration-cleared solutions driven by artificial intelligence, Cleerly supports comprehensive phenotyping of coronary artery disease, as determined from advanced noninvasive computed tomography imaging. Cleerly’s approach is grounded in science, based on millions of images from more than 40,000 patients. Led by a clinical and technical team, Cleerly enhances health literacy for all coronary care stakeholders.