HeartFlow Wins New CPT Code for AI-Enabled Plaque Analysis Tool

The American Medical Association has issued a new Category I CPT (Current Procedural Terminology) code for artificial intelligence (AI)-enabled plaque quantification technology, including HeartFlow Inc.’s Plaque Analysis, effective January 2026. The new code was issued in response to increased use of AI-enabled plaque quantification technology like HeartFlow Plaque Analysis and strong clinical evidence supporting its value.

HeartFlow’s Plaque Analysis is touted as the most clinically validated product and the only U.S. Food and Drug Administration-cleared, AI-enabled plaque quantification tool with a reported 95% agreement with the gold standard, IVUS, in a prospective, international trial using blinded core lab adjudication.¹

“We commend the AMA’s issuance of this upgraded Category I CPT billing code, which validates the technology’s clinical value in quantifying and characterizing plaque to help assess risk and personalize treatment for patients with coronary artery disease,” HeartFlow Chief Medical Officer Campbell Rogers, M.D., said. “It has been shown that with HeartFlow’s Plaque Analysis, two out of three patients had their medical management changed and more precisely tailored, which could contribute to better treatment decisions and improved outcomes.”

A Category III CPT code and payment were previously granted for Plaque Analysis in 2021. Along with the transition to a Category I code, the Centers for Medicare & Medicaid Services (CMS) will establish relative value units (RVUs) for Plaque Analysis, which provides payment to physicians for performing the service.

The successful conversion to a Category I code indicates that AI-enabled plaque quantification is considered consistent with current medical practice. The new reimbursement code complements the recent favorable coverage decision by four of seven Medicare Administrative Contractors, which will begin covering HeartFlow Plaque Analysis on Nov. 24. These milestones will expand patient access to HeartFlow Plaque Analysis, which provides highly accurate plaque quantification and characterization to assess the extent of coronary artery disease (CAD) for personalized treatment.

“It has been shown that with HeartFlow’s Plaque Analysis, two out of three patients had their medical management changed and more precisely tailored, which could contribute to better treatment decisions and improved outcomes.”

HeartFlow Chief Medical Officer Campbell Rogers, M.D.

HeartFlow is dedicated to reshaping cardiovascular care and ensuring that physicians and patients have access to comprehensive, accurate, and efficient solutions in precision coronary care. HeartFlow’s suite of non-invasive technologies helps clinicians characterize and quantify coronary atherosclerosis (Plaque Analysis), identify stenoses in the coronary arteries (RoadMap Analysis), and assess coronary blood flow (FFRCT Analysis).

HeartFlow is transforming precision coronary care with the only AI-powered non-invasive integrated heart care solution across the CCTA pathway. As the pioneer of FFRCT, which is now supported by the ACC/AHA Chest Pain Guideline, HeartFlow continues to advance the diagnosis and management of CAD. HeartFlow’s suite of non-invasive technologies includes its FFRCT Analysis, RoadMap Analysis, and Plaque Analysis. More than 500 peer-reviewed publications have validated the firm’s approach and its technologies have helped clinicians diagnose and manage over 250,000 patients.

Reference
¹ Narula et al. Prospective Deep Learning-based Quantitative Assessment of Coronary Plaque by CT Angiography Compared with Intravascular Ultrasound EHJ 2024