Cleerly® ISCHEMIA™ Device Billable with CPT® Code for Noninvasive FFR Estimates

Cleerly, a pioneer in heart disease diagnosis, has announced that its FDA-cleared Cleerly ISCHEMIA software, applied to non-invasive coronary CT angiograms (CCTA), can now be billed using the new Category I CPT® code 75580. This service, defined by the AMA as a complementary augmented intelligence tool for noninvasive estimates of fractional flow reserve (FFR), aids healthcare professionals in clinical diagnosis and decision-making. This addition of Category I CPT® code complements the existing Category III codes (CPT® 0623T, 0624T, 0625T, 0626T) used for reporting Cleerly’s advanced coronary atherosclerosis analysis.

As of January 1, 2024, the American Medical Association (AMA) has updated its CPT® code set to introduce a new Category I CPT® code 75580. This code describes a “Noninvasive estimate of coronary fractional flow reserve derived from augmentative software analysis of the data set from a coronary computed tomography angiography, with interpretation and report by a physician or other qualified healthcare professional.” The Cleerly ISCHEMIA software produces an index with a threshold equivalent to invasive FFR >0.80 vs. ≤0.80, as defined in professional societal practice guidelines.

The Cleerly ISCHEMIA software generates data that supports clinical decision-making for both the interpreting imaging physician and the treating physician. This analysis allows physicians to examine each lesion across all coronary vessels, facilitating lesion-by-lesion mapping of actionable anatomical and physiological findings of coronary artery disease. This approach offers a deeper understanding of pathology and encourages the development of personalized treatment management plans for patients.

Dr. James P. Earls, Chief Medical Officer of Cleerly, stated, “The Cleerly ISCHEMIA software provides noninvasive estimates of FFR values that help healthcare professionals make critical decisions in the management of patients with suspected coronary artery disease. Cleerly ISCHEMIA was purposely designed to output estimates of FFR values that are guideline-recommended by professional societies, and to allow comprehensive mapping of both anatomic and physiologic data for each and every coronary lesion across the entire vascular tree.”

Previous studies have shown the independent and incremental benefits of Cleerly ISCHEMIA applied to CCTA beyond traditional assessment. Its application supports improvements in physician certainty, guides medical therapy decision-making, and reduces unnecessary invasive and non-invasive testing.

About Cleerly®:

Cleerly aims to eradicate heart attacks by establishing a new standard of care for heart disease. Using FDA-cleared solutions driven by artificial intelligence, Cleerly facilitates comprehensive phenotyping of coronary artery disease through advanced non-invasive CT imaging. Grounded in science and backed by over 10 million images from more than 40,000 patients collected over a 15-year period in landmark, multi-center clinical trials, Cleerly’s approach enhances health literacy for all stakeholders in the coronary care pathway. Led by a world-class clinical and technical team, Cleerly is dedicated to improving coronary care for everyone involved.

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