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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. — Oct. 18, 2024 — HeartFlow, Inc., the global leader in non-invasive artificial intelligence (AI) heart care solutions, today 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 (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 our approach and more importantly, our technologies have helped clinicians diagnose and manage over 250,000 patients. For more information, visit www.heartflow.com.
Elliot Levy
media@heartflow.com
Nick Laudico
VP of Business Development and Investor Relations
nlaudico@heartflow.com
References
HeartFlow Analysis is consisted of four main functions; FFRCT, Planner, Roadmap, and Plaque. All four functions are cleared for clinical use in the United States, Bahrain, Israel, and United Arab Emirates. Only FFRCT and Planner functions are cleared cleared for clinical use in Europe, United Kingdom, Australia, Canada, and Japan. Please see HeartFlow Analysis Indications for Use and Instructions for Use for more information.
© 2024 HeartFlow, Inc. | HeartFlow and the HeartFlow logo are registered trademarks of HeartFlow, Inc. Additionally, RoadMap is claimed as a trademark of HeartFlow, Inc. www.heartflow.com | 331 E Evelyn Ave, Mountain View, CA 94041
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HeartFlow FFRCT 分析は、有資格の臨床医による臨床的に安定した症状のある冠状動脈疾患患者への使用を目的とした個別化された心臓検査です。 HeartFlow Analysis によって提供される情報は、資格のある臨床医が患者の病歴、症状、その他の診断検査、および臨床医の専門的判断と組み合わせて使用することを目的としています。
ハートフロー分析に関する追加の適応情報については、次のサイトをご覧ください。www.heartflow.com/indications.
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The HeartFlow FFRCT Analysis is a personalized cardiac test indicated for use in clinically stable symptomatic patients with coronary artery disease by qualified clinicians. The information provided by the HeartFlow Analysis is intended to be used by qualified clinicians in conjunction with the patient’s history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgement.
For additional indication information about the HeartFlow Analysis, please visit www.heartflow.com/indications.
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Executive Vice President and Chief Medical Officer
Campbell brings a wealth of experience to HeartFlow, where he serves as the Chief Medical Officer. Prior to joining HeartFlow, he was the Chief Scientific Officer and Global Head of Research and Development at Cordis Corporation, Johnson & Johnson, where he was responsible for leading investments and research in cardiovascular devices. Prior to Cordis, he was Associate Professor of Medicine at Harvard Medical School and the Harvard-M.I.T. Division of Health Sciences and Technology, and Director of the Cardiac Catheterization and Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital. He served as Principal Investigator for numerous interventional cardiology device, diagnostic, and pharmacology trials, is the author of numerous journal articles, chapters, and books in the area of coronary artery and other cardiovascular diseases, and was the recipient of research grant awards from the NIH and AHA.
He received his A.B. from Harvard College and his M.D. from Harvard Medical School.