Regulatory

United Healthcare to Cover Elucid’s PlaqueIQ Image Analysis Software

PlaqueIQ is the first and only FDA-cleared, non-invasive plaque analysis based on objective histology.

By: Michael Barbella

Managing Editor

Clinicians using Elucid’s plaque analysis technology will now be reimbursed by United Healthcare.

The health insurer has updated its cardiac imaging guidelines to fully align with recent recommendations from radiology benefit manager EviCore. Accordingly, United Healthcare’s new guidelines now include coronary computed tomography angiography (CTA) plaque quantification (page 520), specifically encompassing Elucid’s PlaqueIQ technology. The coverage will apply to all United Healthcare plans beginning on Oct. 1.

PlaqueIQ is the first and only U.S. Food and Drug Administration-cleared, non-invasive plaque analysis based on objective histology. PlaqueIQ delivers automated quantification and classification of plaque morphology, and can identify and quantify lipid-rich necrotic core, a plaque type strongly linked with cardiovascular risk.1,2 The software is designed to help physicians prioritize and personalize treatment based on actual coronary artery disease, rather than population-based risk. This technology supports physicians in evaluating treatment of patients’ symptoms and risk of future cardiac events, such as heart attack and stroke, and enables the development of personalized care pathways informed by each patient’s individual plaque characteristics.

“United Healthcare’s new guidelines further underscore the need for better tools to help clinicians get ahead of heart attack and stroke,” Elucid CEO Kelly Huang, Ph.D., said. “With its basis in CT Virtual Histology, we believe that PlaqueIQ is poised to make a meaningful difference towards this goal.”

United Healthcare’s updated guidelines align with recently issued guidelines by radiology benefit manager EviCore. In addition to the recent coverage decision by United Healthcare, a new CMS rule took effect on Jan. 1, which doubled the amount paid to hospitals and outpatient clinics that perform cardiac CT scans from $175 to $357.13. This has allowed more hospitals, particularly those in non-urban areas, to be able to offer this service, reducing disparities in care. In late 2024, five of the seven Medicare Administrative Contractors (MACs) issued decisions to extend coverage of Elucid’s PlaqueIQ, making it available to more than 70% of eligible U.S. Medicare patients. The newly assigned Category I code for coronary plaque analysis, which takes effect Jan. 1, 2026, complements the recent coverage decisions by United Healthcare and EviCore, allowing for expanded patient access and personalized treatment for patients with coronary artery disease (CAD).

Elucid is a Boston-based AI medical technology company developing technology designed to provide physicians with a more precise view of atherosclerosis (coronary plaque buildup), the root cause of cardiovascular disease. The company’s PlaqueIQ image analysis software helps physicians prioritize and personalize treatment based on actual disease, rather than population-based disease risk. PlaqueIQ equips physicians with critical information regarding the type and amount of plaque in arteries that can lead to heart attack and stroke. Elucid is also pursuing an indication for FFRCT, derived from its plaque algorithm, to help identify coronary blockages and the extent of ischemia non-invasively.

References
1 https://www.ahajournals.org/doi/10.1161/01.ATV.20.5.1262
2 https://pubmed.ncbi.nlm.nih.gov/39600843/

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