Bunkerhill Health has announced two regulatory milestones supporting the adoption of artificial intelligence in cardiovascular imaging: the establishment of a national reimbursement pathway by the Centers for Medicare and Medicaid Services (CMS) and U.S. Food and Drug Administration (FDA) clearance for new AI algorithms designed to analyze calcium in chest CT scans.
Effective April 1, 2026, CMS has introduced a national billing code under the Hospital Outpatient Prospective Payment System (OPPS) for algorithmic analysis of coronary artery calcium (CAC) and aortic valve calcium (AVC). Bunkerhill Health led the submission through the New Technology APC pathway and worked directly with CMS to define how such AI-enabled analyses can be evaluated and reimbursed in clinical practice.
“Establishing a reimbursement pathway is an important step toward broader adoption of AI in clinical care,” said Nishith Khandwala, co-founder and CEO of Bunkerhill Health. “We worked closely with CMS to help define how this technology can be evaluated and supported in practice. With this pathway in place, health systems have greater clarity on how to incorporate AI-driven insights into clinical workflows in appropriate clinical contexts to help identify and manage patients with meaningful cardiovascular findings.”
In parallel, the FDA has cleared Bunkerhill Contrast CAC and Bunkerhill Contrast AVC, described as the first AI algorithms authorized to detect and quantify coronary artery and aortic valve calcium on contrast-enhanced, routine non-gated chest CT scans. These clearances expand the company’s prior capabilities for non-contrast imaging, enabling analysis across a broader range of commonly performed scans.
The algorithms are designed to identify clinically significant cardiovascular findings from imaging already conducted for other indications. Millions of chest CT scans are performed annually, and the ability to extract additional diagnostic insight from these studies may support earlier identification of at-risk patients.
“Coronary artery and aortic valve calcification carry important implications for cardiovascular risk and disease progression,” said Alexander Sandhu, MD, MS, associate professor in the Division of Cardiology at the University of California, Los Angeles, David Geffen School of Medicine. “The ability to detect and quantify these highly actionable findings on contrast-enhanced routine chest CT scans creates new opportunities to capture clinically relevant information and improve quality of care from imaging that is already being performed at scale.”
The technology was developed in collaboration with academic partners including UCSF, Emory University, and MedStar Health. The algorithms are deployed through Carebricks, Bunkerhill’s AI platform, which enables health systems to integrate AI agents into clinical workflows for tasks such as follow-up coordination and care management.
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