#United States #Stamford #Caristo Diagnostics #CaRi-Plaque #Medicare Reimbursement

Medicare's New Reimbursement Model for CaRi-Plaque™

Caristo Diagnostics, a pioneer in cardiovascular disease diagnostics, has reached a significant milestone with the announcement from the Centers for Medicare & Medicaid Services (CMS) regarding its innovative product, CaRi-Plaque™. The new reimbursement rate of $950.50 under the Hospital Outpatient Prospective Payment System (OPPS) will enable hospitals, imaging centers, and physicians to integrate this advanced AI-powered coronary plaque analysis into their services starting in 2026.

This development marks the completion of two major Medicare reimbursement pathways, allowing CaRi-Plaque to be utilized not only in hospital outpatient settings but also in physician offices and imaging centers where coronary CT angiography (CCTA) is routinely performed. A new Category I CPT® code (75577) was introduced for the AI-based quantification and characterization of coronary atherosclerotic plaque, with a scheduled payment rate of over $1,000 under the 2026 Physician Fee Schedule (PFS). This comprehensive coverage represents a significant step forward in ensuring that healthcare providers have a unified path to effectively utilize AI-enhanced diagnostic tools.

Frank Cheng, CEO of Caristo Diagnostics, emphasized the importance of this decision, stating, "CMS should be applauded for recognizing the value of AI-augmented plaque analysis of CCTA, which helps cardiologists assess severity of coronary disease." With established payment structures in place, cardiac imaging and prevention professionals can now confidently incorporate CaRi-Plaque into their routine workflows—ensuring Medicare patients have access to advanced diagnostic tools designed for early detection of coronary disease.

What is CaRi-Plaque™?

CaRi-Plaque quantifies coronary plaque burden and identifies high-risk features on standard CCTA scans. Traditionally, this process was labor-intensive, relying on manual interpretation by healthcare professionals. The technology represents a significant advancement in the field of cardiovascular diagnostics and complements Caristo’s flagship product, CaRi-Heart®, which is focused on detecting hidden coronary inflammation.

As part of Caristo’s broader mission to save lives through the early detection and prevention of heart disease, CaRi-Heart is currently under review by the FDA. Its efficacy has already been demonstrated in clinical settings across Europe, where it has gained acceptance among hospitals and clinics. Notably, a landmark study published in The Lancet in 2024 revealed that CaRi-Heart can identify hidden inflammation markers, predicting the onset of heart attacks up to a decade ahead of time.

Looking Ahead to 2026

Under the new CMS ruling, hospitals will be able to bill Medicare for CaRi-Plaque beginning January 1, 2026. This is not only a remarkable opportunity for healthcare providers to enhance their diagnostic capabilities but also a commitment to improving patient care through innovative technology. As Caristo works with various hospitals and imaging centers across the U.S. to facilitate the integration of CaRi-Plaque, the landscape for cardiovascular disease assessment is set to transform.

Caristo Diagnostics was founded as a spin-out from the University of Oxford and has quickly established itself as a global leader in cardiovascular diagnostics and risk prediction technology. The company partners with leading hospitals, pharmaceutical firms, and top scientists to advance the frontiers of heart disease prevention and treatment.

For more information about CaRi-Plaque and other innovative solutions, visit Caristo's official website at caristo.com. Stay updated by following Caristo on LinkedIn, YouTube, Instagram, and X.

This development signals a promising future for AI in healthcare—and a tangible move towards more personalized, efficient, and effective cardiovascular care across the United States.