HeartFlow Announces New Category I CPT Code from the American Medical Association for AI-Enabled Plaque Analysis to Assess Risk for Coronary Artery Disease

New reimbursement code follows recent favorable Medicare coverage decision, expanding access to HeartFlow’s Plaque Analysis to help physicians provide personalized treatment plans

MOUNTAIN VIEW, Calif. — HeartFlow, Inc. announced that the American Medical Association (AMA) has issued a new Category I Current Procedural Terminology (CPT^®) code for AI-enabled plaque quantification technology, including HeartFlow Plaque Analysis effective January 2026. The new code was issued in response to increased utilization of AI-enabled plaque quantification technology like HeartFlow Plaque Analysis and strong clinical evidence supporting its value.

HeartFlow’s Plaque Analysis is the most clinically validated product and is the only FDA-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,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer of HeartFlow. “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 November 24, 2024. 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.

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 (FFR_CT Analysis).

About HeartFlow, Inc.

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 FFR_CT, 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 FFR_CT Analysis, RoadMap™ Analysis, and Plaque Analysis. More than 500 peer-reviewed publications have validated our approach and more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com.

Reference

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

Find More:

Cardiovascular Ambulatory Surgery Centers (ASCs) Topic Center

The Latest Clinical & Industry News

Case Reports

Grand Rounds With Morton Kern, MD

Watch: Cath Lab Live Videos

Podcasts: Cath Lab Conversations

Go to Cath Lab Digest's current issue page