Cleerly Coverage

Coverage Criteria

• Consult your Medicare Administrative Contractor (MAC) local coverage determination (LCD) for specifics on coverage, restrictions and diagnostic codes.

Consult with your jurisdictional Medicare Local Coverage Determinations (LCDs) for any coverage guidance and limitations of coverage. Even LCDs can vary by jurisdictions.

Medicare Coverage Guidance

• Intermediate-risk patients with acute or stable chest pain and with no known history coronary artery stenosis with finding of 40-90% in proximal or middle coronary artery on CCTA OR
• Patients with acute chest pain and known non-obstructive (<50%) CAD coronary artery stenosis with finding of 40-90% stenosis on CCTA OR
• Stable nonobstructive coronary artery disease (<50% stenosis) with persistent symptoms requiring further test, and finding of 40-90% stenosis on CCTA
  AND
  Not in conjunction with stress testing (unless CCTA was not sufficient quality for FFRCT, and an alternative study is needed)

Medicare Coverage Limitations

1. Prior placement of prosthetic valves
2. Prior placement of grafts in coronary bypass surgery
3. Suspicion of acute coronary syndrome (where MI or unstable angina have not been ruled out)
4. Intracoronary metallic stent
5. Status post-heart transplantation
6. Recent MI (30 days or less)
7. Prior pacemaker or defibrillator lead placement
8. Newly diagnosed systolic heart failure, with no prior left heart catherization
9. Left main coronary artery disease with Intermediated Coronary Stenosis (lumen reduction less than or equal to 40%)
10. Non-obstructing stenosis (<50% of all major epicardial vessels) on CTA or catherization in the past twelve months, in the absence of a new symptom complex.
11. If turnaround times may impact prompt clinical care decisions

Medicare Coverage Guidance

AI-QCT/AI-CPA using CCTA is considered reasonable and medically necessary as a diagnostic study when:

• The patient has acute or stable chest pain with no known CAD1 and is eligible for CCTA*, AND
• CCTA classifies patient as:
  • Intermediate risk ** OR
  • CAD-RADs 1, CAD-RADS 2 or CAD-RADS 3*** category on CCTA 
    AND
  • Cardiac evaluation is negative or inconclusive for acute coronary syndrome (ACS)

Medicare Coverage Limitations

AI-QCT/AI-CPA is NOT considered reasonable or necessary in the following clinical circumstance (non-covered):

1. Screening, (i.e., in the absence of signs, symptoms, or disease)
2. When there is a contraindication to CCTA
3. In conjunction with invasive coronary catheterization
4. In the presence of normal CCTA results (CAD RADS=0 or no plaque disease)
5. In the presence of high-grade stenosis (>70%) or CAD RADS-4 and RADS-5
6. Within 30 days of a myocardial infarction (MI)
7. In the presence of unstable coronary symptoms
8. For disease surveillance

2026 - Coding Update

AMA/CPT^® approved AI-QCT/AI-CPA on October 14, 2024 with a Category I CPT^® code that replaced 0623T-0626T. The Category I CPT^® Code:

• 75577 (Cleerly Plaque Analysis)
  • “Quantification and characterization of coronary atherosclerotic plaque to assess severity of coronary disease, derived from augmentative software analysis of the data set from a coronary computed tomographic angiography, with interpretation and report by a physician or other qualified health care professional.” Work associated with the Cleerly plaque analysis is reported using CPT^® 75577 effective January 1, 2026.