Medicare Finalizes Reimbursement for Caristo's CaRi-Plaque™ Across Hospital and Office Settings

New OPPS and PFS reimbursement rates give hospitals, imaging centers and physicians a unified path to use AI plaque analysis starting 2026

STAMFORD, Conn., Nov. 25, 2025 /PRNewswire/ -- Caristo Diagnostics, on a mission to transform the diagnosis and treatment of cardiovascular disease, announced today that the Centers for Medicare & Medicaid Services (CMS) has set a $950.50 Medicare reimbursement rate under the Hospital Outpatient Prospective Payment System (OPPS) for CaRi-Plaque™, the company's AI-powered coronary plaque analysis performed on coronary CT angiography (CCTA) scans.

The decision completes the two major Medicare reimbursement pathways for nationwide use of CaRi-Plaque. Based on a new Category I CPT® code (75577) for AI quantification and characterization of coronary atherosclerotic plaque derived from analysis of CCTA, CMS recently set a 2026 Physician Fee Schedule (PFS) payment rate of over $1,000 for use of CaRi-Plaque analysis in physician offices and imaging centers. Now with CMS's establishment of the companion OPPS payment rate for the hospital outpatient setting, CaRi-Plaque has complete Medicare coverage across the two settings where CCTA is most often performed.

"CMS should be applauded for recognizing the value of AI-augmented plaque analysis of CCTA, which helps cardiologists assess severity of coronary disease," said Caristo CEO Frank Cheng. "With established payment in both hospital outpatient and physician-office settings, cardiac imaging and prevention professionals finally have a clear path to make CaRi-Plaque part of routine CCTA workflows. It's a critical step toward ensuring Medicare patients have access to the most advanced tools for coronary disease assessment."

Under the new ruling, hospitals can bill Medicare for CaRi-Plaque beginning January 1, 2026, when the new Category I CPT code (75577), and 2026 OPPS and PFS payments rates will all take effect. The decision arrives as CMS continues to expand support for emerging AI diagnostic tools.

CaRi-Plaque quantifies coronary plaque burden and high-risk features on standard CCTA, work that traditionally requires labor-intensive manual interpretation. The technology complements Caristo's flagship CaRi-Heart® technology, which uncovers hidden coronary inflammation on routine CCTA. Currently under FDA review, CaRi-Heart is used widely by hospitals and clinics in Europe and marks a significant advance in heart disease prevention and diagnosis. A landmark 2024 study in The Lancet proved that the technology can reveal hidden, high-risk inflammation markers of coronary artery disease progression — predicting heart attacks up to a decade before they strike.

Caristo is currently working with hospitals and imaging centers across the U.S. to support CaRi-Plaque integration and prepare for 2026 billing.

About Caristo Diagnostics

Caristo Diagnostics is a global leader in cardiovascular disease diagnostics and risk prediction, founded as a spin-out company from the University of Oxford. Caristo's award-winning technology is transforming cardiovascular care by identifying hidden heart attack risks before symptoms appear. In collaboration with leading hospitals, pharmaceutical companies and world-renowned scientists, Caristo is on a mission to save lives through early detection and personalized prevention. For more information, visit caristo.com. Find Caristo online on LinkedIn, YouTube, Instagram, and X.

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SOURCE CARISTO DIAGNOSTICS