Cleerly announced that Aetna will begin covering the Cleerly LABS plaque analysis effective immediately. Aetna, which covers more than 20 million patients, joins UnitedHealthcare, Cigna, Humana, BCBS Kansas City, Excellus BCBS, and EviCore in providing coverage for this advanced technology. 

Cleerly LABS is an interactive analysis software that leverages AI/ML-based advanced plaque analysis to identify, characterize, and quantify coronary artery plaque and stenosis, supporting visualization and measurement of coronary arteries in patients with known or suspected coronary artery disease (CAD).

Aetna’s coverage reflects the rapid industry adoption of Artificial Intelligence Enabled CT-Based Quantitative Coronary Tomography (AI-QCT)/Coronary Plaque Analysis (AI-CPA) in cardiovascular care, according to Cleerly. Following Medicare’s 2024 coverage decision and the technology’s approval for a CPT I code effective Jan. 1, 2026, major commercial payers representing more than 86 million Americans now support AI-QCT/AI-CPA coverage.

Coverage Criteria

CCTA plaque quantification or coronary plaque analysis using data from CCTA when all of the following criteria are met:

• The plaque quantification and/or analysis platform has been cleared by the U.S. Food and Drug Administration (FDA); and
• The member has acute or stable chest pain with no known coronary artery disease (CAD); and
• The member has had a current CCTA and the results indicate any of the following risk categories; Note: CCTA plaque quantification or coronary plaque analysis is not indicated for CAD-RAD 4, 5, and/or N; see Appendix for category definitions:
  • Intermediate risk
  • CAD-RADS 1
  • CAD-RADS 2
  • CAD-RADS 3; and
• Physical examination and other cardiac testing (e.g., electrocardiogram, laboratory testing) are negative or inconclusive for acute coronary syndrome

“We’re seeing unprecedented payor acceptance of AI-powered cardiovascular imaging,” Cleerly Founder/CEO James K. Min, M.D., stated. “Major insurers, covering over 86 million lives, now recognize that AI-QCT delivers better patient outcomes while reducing costs. This is a fundamental shift in how we approach cardiac care.”

This growing payer support reflects increasing clinical evidence that AI-QCT/AI-CPA supports the assessment of coronary artery disease by enhancing diagnostic evaluation and enabling efficient use of healthcare resources, Cleerly bigwigs claim. These advances are critical for addressing cardiovascular disease, the leading cause of death in the United States.

Cleerly aims to eliminate heart attacks by creating a new standard of care for heart disease. Through its FDA-cleared solutions driven by artificial intelligence, Cleerly supports comprehensive phenotyping of coronary artery disease, as determined from advanced noninvasive CT imaging. Cleerly’s approach is grounded in science, based on millions of images from more than 40,000 patients. Led by a clinical and technical team, Cleerly enhances health literacy for all stakeholders in the coronary care pathway.