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.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0375UCPTProprietary Laboratory AnalysesOvaWatchOvarian cancer riskLaboratory diagnosticsAlgorithmic assayReference laboratoryBiomarker panel

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.

Service type: Laboratory diagnostic assay with algorithmic risk stratification
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.
`26`	Professional component	Use when billing only the physician/professional interpretation portion if separated from technical lab service.
`TC`	Technical component	Use when billing only the laboratory/technical component that performed the assay.
`QX`	Modifier for assistant-at-surgery (when applicable)	Not typically applicable to a lab test; included for completeness if an assistant service is billed with associated procedures.
`QY`	Clinical trial professional component	Use when the professional component is furnished as part of an approved clinical trial per payer rules.
`QK`	Medical direction of 2-4 ancillary personnel	Not typically used for this lab test; apply only if specific billing arrangements require it.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist billing	Use when an eligible non-physician practitioner is the ordering or supervising clinician per payer rules.
`FY`	Reimbursement of a lab test performed outside the U.S.	Use only if the laboratory service is performed internationally and payer accepts modifier `FY`.
`52`	Reduced services	Use when the test or reporting is partially reduced compared with the full-service assay and payer allows reduced service reporting.
`53`	Discontinued procedure	Use if the sample collection or testing was attempted but discontinued for clinical reasons prior to completion.
`78`	Return to operating room for a related procedure	Not typical for this assay; include only when subsequent intraoperative procedures relate directly to prior billed services.
`80`	Assistant at surgery	Not typical for this lab test; included only if surgical care billed in the same episode requires this modifier.
`62`	Two surgeons	Rarely applicable; use only when separate surgical services in the same episode are billed with this test as part of the plan.

Taxonomy Code	Specialty	Notes
207V00000X	Obstetrics & Gynecology	Gynecologists often order and interpret ovarian mass risk assays.
207Q00000X	Gynecologic Oncology	Gynecologic oncologists use the test for surgical planning and risk stratification.
208D00000X	Pathology / Clinical Laboratory	Clinical pathologists and laboratory directors oversee assay validation and reporting.
363L00000X	Diagnostic Radiology	Radiologists correlate imaging findings with biomarker risk assessments.
363A00000X	Internal Medicine	Primary care or hospitalists may order the test when coordinating initial evaluation.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`N83.2`	Ovarian cyst	Common indication for ordering the assay to further risk-stratify an adnexal mass.
`N83.20`	Unspecified ovarian cyst	Used when documentation describes an ovarian cyst without further specification; relevant to test ordering.
`N83.0`	Follicular cyst of ovary	Benign-appearing cyst type where biomarker testing may help avoid unnecessary surgery.
`N83.9`	Noninflammatory disorder of ovary, unspecified	Broad code used for adnexal masses when precise diagnosis is pending and assay aids evaluation.
`C56.9`	Malignant neoplasm of ovary, unspecified	Relevant when pretest probability or imaging raises concern for malignancy and risk score informs management.
`R87.619`	Abnormal cytology of ovary (if applicable)	Used when cytology or other abnormal test results accompany imaging and biomarker testing.
`R10.2`	Pelvic and perineal pain	Symptom prompting evaluation of adnexal mass and consideration of the assay.
`Z01.818`	Encounter for other preprocedural examination	Administrative code used when testing is ordered as part of preoperative evaluation prior to planned adnexal surgery.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0375U`	OvaWatch? Assay — proprietary PLA code for a seven‑biomarker blood test with algorithmic risk score for ovarian cancer	This is the primary code to report the laboratory assay and algorithmic interpretation performed by Aspira Labs Inc.
`36415`	Collection of venous blood by venipuncture	Performed immediately prior to laboratory testing to obtain the specimen for `0375U`.
`83036`	Hemoglobin; glycosylated (A1c) — example general chemistry code (representative lab CPT)	Representative of routine lab tests often performed concurrently; not specific to the assay but commonly billed during the same encounter.
`84153`	Tumor marker, CA 125 antigen; quantitative	Commonly ordered classic serum tumor marker for ovarian cancer that may be used alongside `0375U` for clinical correlation.
`88305`	Pathology, surgical pathology, gross and microscopic examination (level IV)	May be billed later if a surgical specimen from the adnexal mass is obtained for histopathologic diagnosis following risk stratification with `0375U`.

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Summary & Overview

CPT 0375U: OvaWatch Assay for Ovarian Mass Risk Assessment

Billing Code Overview

Service type: Laboratory diagnostic assay with algorithmic risk stratification
Typical site of service: Clinical laboratory or reference laboratory processing blood specimens

Clinical & Coding Specifications

Clinical Context

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.
`26`	Professional component	Use when billing only the physician/professional interpretation portion if separated from technical lab service.
`TC`	Technical component	Use when billing only the laboratory/technical component that performed the assay.
`QX`	Modifier for assistant-at-surgery (when applicable)	Not typically applicable to a lab test; included for completeness if an assistant service is billed with associated procedures.
`QY`	Clinical trial professional component	Use when the professional component is furnished as part of an approved clinical trial per payer rules.
`QK`	Medical direction of 2-4 ancillary personnel	Not typically used for this lab test; apply only if specific billing arrangements require it.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist billing	Use when an eligible non-physician practitioner is the ordering or supervising clinician per payer rules.
`FY`	Reimbursement of a lab test performed outside the U.S.	Use only if the laboratory service is performed internationally and payer accepts modifier `FY`.
`52`	Reduced services	Use when the test or reporting is partially reduced compared with the full-service assay and payer allows reduced service reporting.
`53`	Discontinued procedure	Use if the sample collection or testing was attempted but discontinued for clinical reasons prior to completion.
`78`	Return to operating room for a related procedure	Not typical for this assay; include only when subsequent intraoperative procedures relate directly to prior billed services.
`80`	Assistant at surgery	Not typical for this lab test; included only if surgical care billed in the same episode requires this modifier.
`62`	Two surgeons	Rarely applicable; use only when separate surgical services in the same episode are billed with this test as part of the plan.

Taxonomy Code	Specialty	Notes
207V00000X	Obstetrics & Gynecology	Gynecologists often order and interpret ovarian mass risk assays.
207Q00000X	Gynecologic Oncology	Gynecologic oncologists use the test for surgical planning and risk stratification.
208D00000X	Pathology / Clinical Laboratory	Clinical pathologists and laboratory directors oversee assay validation and reporting.
363L00000X	Diagnostic Radiology	Radiologists correlate imaging findings with biomarker risk assessments.
363A00000X	Internal Medicine	Primary care or hospitalists may order the test when coordinating initial evaluation.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`N83.2`	Ovarian cyst	Common indication for ordering the assay to further risk-stratify an adnexal mass.
`N83.20`	Unspecified ovarian cyst	Used when documentation describes an ovarian cyst without further specification; relevant to test ordering.
`N83.0`	Follicular cyst of ovary	Benign-appearing cyst type where biomarker testing may help avoid unnecessary surgery.
`N83.9`	Noninflammatory disorder of ovary, unspecified	Broad code used for adnexal masses when precise diagnosis is pending and assay aids evaluation.
`C56.9`	Malignant neoplasm of ovary, unspecified	Relevant when pretest probability or imaging raises concern for malignancy and risk score informs management.
`R87.619`	Abnormal cytology of ovary (if applicable)	Used when cytology or other abnormal test results accompany imaging and biomarker testing.
`R10.2`	Pelvic and perineal pain	Symptom prompting evaluation of adnexal mass and consideration of the assay.
`Z01.818`	Encounter for other preprocedural examination	Administrative code used when testing is ordered as part of preoperative evaluation prior to planned adnexal surgery.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0375U`	OvaWatch? Assay — proprietary PLA code for a seven‑biomarker blood test with algorithmic risk score for ovarian cancer	This is the primary code to report the laboratory assay and algorithmic interpretation performed by Aspira Labs Inc.
`36415`	Collection of venous blood by venipuncture	Performed immediately prior to laboratory testing to obtain the specimen for `0375U`.
`83036`	Hemoglobin; glycosylated (A1c) — example general chemistry code (representative lab CPT)	Representative of routine lab tests often performed concurrently; not specific to the assay but commonly billed during the same encounter.
`84153`	Tumor marker, CA 125 antigen; quantitative	Commonly ordered classic serum tumor marker for ovarian cancer that may be used alongside `0375U` for clinical correlation.
`88305`	Pathology, surgical pathology, gross and microscopic examination (level IV)	May be billed later if a surgical specimen from the adnexal mass is obtained for histopathologic diagnosis following risk stratification with `0375U`.