Summary & Overview
CPT 0375U: OvaWatch Assay for Ovarian Mass Risk Assessment
CPT code 0375U designates the proprietary OvaWatch? Assay from Aspira Labs Inc., a laboratory test that measures seven biomarker proteins in a blood sample and applies an algorithm to estimate risk of ovarian cancer in patients with an ovarian mass. Nationally, PLA codes like 0375U matter because they identify manufacturer- or lab-specific tests with unique clinical algorithms that can affect diagnostic pathways, referral decisions, and utilization of surgical versus conservative management.
Key payers examined include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find concise benchmarks for payer coverage patterns, an overview of clinical context for use in patients with ovarian masses, and policy considerations that influence coding and billing for proprietary assays. The publication outlines common billing modifiers applicable to laboratory services and notes where payer policy text or coverage criteria may be relevant.
The report provides guidance on documentation elements linked to algorithmic laboratory assays, summarizes typical sites of service and service type, and highlights areas where payers commonly require medical necessity justification or prior authorization. Data not available in the input are clearly identified where gaps exist.
Billing Code Overview
CPT code 0375U is a Proprietary Laboratory Analyses (PLA) code for the OvaWatch? Assay produced by Aspira Labs Inc. The test analyzes a blood specimen from a patient with an ovarian mass to measure levels of seven specified biomarker proteins and applies an algorithmic analysis incorporating patient data to generate an individualized risk assessment for ovarian cancer.
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Service type: Laboratory diagnostic assay with algorithmic risk stratification
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Typical site of service: Clinical laboratory or reference laboratory processing blood specimens
Clinical & Coding Specifications
Clinical Context
A 52-year-old woman presents to gynecologic oncology clinic with a newly identified adnexal mass on pelvic ultrasound and indeterminate serum CA-125 values. The clinician documents a concern for possible epithelial ovarian malignancy and orders a blood-based proprietary assay to aid risk stratification prior to deciding on surgery versus surveillance. A single venous blood specimen is drawn in an outpatient clinic or hospital outpatient phlebotomy area and sent to the manufacturer-specific laboratory (Aspira Labs Inc.). The laboratory measures seven protein biomarkers and applies a proprietary algorithm combining biomarker results with patient data (age, menopausal status, clinical features) to generate an individualized risk score for ovarian cancer. Results are returned in the electronic medical record to the ordering clinician, who integrates the risk estimate with imaging, clinical exam, and patient preferences to determine next steps (referral to gynecologic oncology, planned surgical approach, or conservative management). Typical sites of service include outpatient clinic, outpatient laboratory, and hospital outpatient departments. The service type is a single-sample, laboratory-based proprietary algorithmic diagnostic test with analytic and interpretive components performed by a specific laboratory.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Placeholder / no modifier | Use when no specific modifier applies and none of the listed modifiers are relevant. |