Summary & Overview
CPT 81500: CA-125 and HE4 Laboratory Testing with Algorithmic Risk Score
CPT code 81500 covers a lab-based service that combines assays for CA-125 and HE4 with an algorithmic analysis of patient data to produce a patient-specific risk score. This molecular/biomarker testing with algorithmic interpretation supports clinical decision-making in assessing disease risk, and its use has implications for diagnostic pathways, care coordination, and laboratory workflows nationwide.
Key payers included in the national analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical context for CA-125 and HE4 biomarker testing, national reimbursement benchmarks where available, coding and billing considerations for a laboratory performing both the technical assays and algorithmic reporting, and the policy landscape influencing coverage for algorithm-based diagnostic tests. The publication outlines operational implications for clinical laboratories and diagnostic facilities and highlights areas where payer policies and coding practices intersect with clinical use of algorithmic risk scores.
Data not available in the input for specific reimbursement rates, associated taxonomies, or ICD-10 diagnosis mappings is noted where applicable.
Billing Code Overview
CPT code 81500 describes a laboratory service in which the lab analyst performs the technical assays for CA-125 and HE4 and applies an algorithmic analysis to combine those test results with patient data to generate and report a patient risk score. The service type is laboratory molecular/biomarker testing with algorithmic risk assessment. The typical site of service is a clinical laboratory or diagnostic testing facility, where specimen processing, assay performance, and computational analysis are completed and the resulting risk score is reported to the ordering clinician.
Clinical & Coding Specifications
Clinical Context
A 56-year-old woman with a pelvic mass and abnormal transvaginal ultrasound is seen in a gynecologic oncology clinic to evaluate risk for epithelial ovarian cancer. Her clinician orders serum biomarker testing for CA-125 and HE4, and sends the sample to a reference laboratory that performs the technical assays and applies an FDA-cleared algorithm combining the two markers with patient age and menopausal status to generate a numerical risk score. The laboratory analyst receives the specimen, performs immunoassays for CA-125 and HE4, verifies quality controls, enters patient demographic variables, runs the risk‑prediction algorithm, documents the technical results and algorithm output, and reports the patient risk score to the ordering provider via the laboratory information system. Results inform shared decision-making about further imaging, referral to gynecologic oncology, or surgical planning.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing only the professional interpretation component by the physician when applicable (rare for purely technical lab tests). |