Elucid has announced that Noridian will begin covering AI-enabled quantitative coronary plaque analysis, including its FDA-cleared PlaqueIQ™ image analysis software, starting December 8, 2024. With this decision, five out of seven Medicare Administrative Contractors (MACs) will offer coverage for this technology, increasing access for over 70 percent of eligible Medicare patients nationwide.
The updated policy will allow Medicare patients with acute or stable chest pain and no known history of cardiovascular disease, covered by five MACs, to be evaluated using AI-enabled plaque imaging software. Elucid’s PlaqueIQ™ is designed to assist physicians in accurately diagnosing and personalizing treatment for cardiovascular disease.
“AI-enabled plaque software enables precise quantification of atherosclerosis, allowing clinicians to tailor treatments based on plaque burden and types, advancing us into personalized medicine,” said Dr. Matthew Jay Budoff, professor of medicine at UCLA. “This has significant implications for patient care, aligning treatment intensity with risk levels.”
Cardiovascular disease (CVD) is the leading cause of death and disability worldwide, primarily due to myocardial infarction and ischemic stroke from atherosclerosis. In the U.S., the cost of CVD is about $219 billion annually, including healthcare services, medications, and lost productivity. This cost is expected to more than triple for individuals over 80 and more than double for those aged 65 to 79 by 2035.
Elucid’s PlaqueIQ is the first FDA-cleared non-invasive software that objectively quantifies and classifies plaque morphology based on histology, the gold standard for plaque characterization. It provides clinicians with clinically validated data to help stratify patients and create personalized treatment plans.
“This expanded coverage by Noridian could significantly benefit more patients through PlaqueIQ, which uniquely measures lipid-rich necrotic core—a high-risk plaque component associated with heart attacks and strokes,” said Kelly Huang, CEO of Elucid. “This recognition from five of the seven MACs underscores the value of innovative technologies that quantify coronary artery plaque to help reduce the clinical and economic burdens of cardiovascular disease.”
PlaqueIQ leverages first-line diagnostic CCTA to generate comprehensive, interactive reports that help physicians visualize and quantify plaque. Its histology-based approach allows for non-invasive quantification and characterization of plaque components, such as lipid-rich necrotic core, providing insights into high-risk plaques that could lead to heart attacks and strokes. Additionally, it may facilitate earlier identification of high-risk plaques before symptoms or major adverse events occur.
About Elucid
Elucid is a Boston-based AI medical technology company focused on providing a clearer understanding of atherosclerosis, the underlying cause of cardiovascular disease. Its PlaqueIQ™ product helps physicians prioritize and personalize treatment based on actual disease status rather than population-based risk. PlaqueIQ is the only FDA-cleared CTA algorithm that quantifies plaque morphology validated against histology, as confirmed by leading pathologists. Elucid is also developing an indication for FFRCT, derived from its plaque algorithm, to non-invasively identify coronary blockages and ischemia.