Cleerly Coverage

Coverage Criteria

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

Coverage Restrictions

• Consult your local jurisdiction MAC’s LCD for specifics

Payment for 2025

• Physician Fee Schedule (PFS)
  • CPT® 75574 = $318.29 (2% reduction from 2024 of $329.55) (in office)
  • CPT® 75574–TC = $209.28 (4% reduction from 2024 of $218.37) (in office)
  • CPT® 75574–26 = $111.18 (2% reduction from 2024 of $111.18) (in office)
• Outpatient Prospective Payment System (OPPS)
  • CPT® 75574 = $357.13 (104% increase from 2024 of $175.06 – moved to a higher APC, which has more than doubled the reimbursement amount)

Coverage Criteria

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

Coverage Restrictions

• Consult your local jurisdiction MAC’s LCD for specifics

Payment for 2025

• PFS
  • CPT® 75580 = $839.07 (Non-Facility) (7% reduction from 2024 of $902.76) (in office)
  • CPT® 75580-TC = $805.43 (Non-Facility) (7% reduction from 2024 of $868.14) (in office)
  • CPT® 75580-26 = $33.64 (Non-Facility) (3% reduction from 2024 of $34.62) (in office)
  • CPT® 75580-26 = $33.64 (Facility)
• OPPS
  • CPT® 75580 = $1017.39 (2% increase from 2024 of $996.18)

Criteria

• AI-QCT/AI-CPA (AI-Quantitative Coronary Topography/AI-Coronary Plaque Analysis) 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
• CCTA classifies patient as:
  • Intermediate risk OR
  • CAD-RADS 1, CAD-RADS 2 or CAD-RADS 31,2
  • AI-QCT/AI-CPA should not be performed until after the base study (CCTA) has been completed and interpreted

Coverage Restrictions

• Software to perform AI-QCT/AI-CPA must be FDA cleared or approved
• AI-QCT/AI-CPA is NOT considered reasonable or necessary in the following clinical circumstance (non-covered):
  • Screening, i.e., in the absence of signs, symptoms, or disease
  • When there is a contraindication to CCTA
  • In conjunction with invasive coronary catheterization
  • In the presence of normal CCTA results (CAD RADS=0 or no plaque disease)
  • In the presence of high-grade stenosis (>70%) or CAD RADS-4 and RADS-5
  • Within 30 days of a myocardial infarction (MI)
  • In the presence of unstable coronary symptoms
  • For disease surveillance

Documentation
The patient’s medical record shall document all of the following:

• History and physical exam with detail sufficient to assess pre-test probability for CAD
• Description of symptoms consistent with stable ischemic heart disease
• The clinical findings that led to the initial performance of the CCTA
• The CCTA must be completed and interpreted before the performance of AI-QCT/AI-CPA
  • The clinical indication for the addition of AI-QCT/AI-CPA must be documented
• Coronary computed tomographic angiography report
• AI-QCT/AI-CPA analysis report

2025 - Coding

• 0623T (Global) algorithmic analysis of CCTA to characterize and quantify plaque, inclusive of all components of the service
• 0624T (Site) data transmission
• 0625T (Technical) algorithmic analysis of CCTA (ie, Cleerly service)
• 0626T (Professional) interpretation and report of Cleerly service
• ICD-10-Code that supports medical necessity
• 1 - Abnormal findings on diagnostic imaging of heart and coronary circulation*

2025 - Payment

• PFS = carrier priced
• OPPS = APC 1511, $950.50, Status Indicator “S” (procedure is paid under OPPS and it is not discounted)
• MACs specific variations or relevant information
• First Coast Service Options (FCSO) and Novitas do NOT have an LCD in place and will continue to provide payment via the PFS

2026 - Coding

• NEW Category I CPT® code has been approved and is scheduled to take effect on January 1, 2026