Summary & Overview
CPT 86305: HE4 Quantitative Serum Tumor Marker for Ovarian Cancer
CPT code 86305 represents a quantitative serum assay for human epididymis protein 4 (HE4), a tumor marker associated with ovarian cancer. Nationally, utilization of tumor marker assays like HE4 affects diagnostic pathways, laboratory workflow, and payer coverage decisions because HE4 can contribute to risk assessment and disease monitoring alongside clinical evaluation and imaging. Coverage and reimbursement policies for 86305 influence access to this ancillary diagnostic tool across outpatient and inpatient settings.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical context for HE4 testing, typical sites of service (clinical and hospital laboratories), and the relevance of this assay to oncology diagnostic and surveillance workflows. The publication also summarizes common modifiers and coding considerations supplied in the input and highlights areas where policy updates or payer-specific coverage rules may affect ordering and billing practices. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 86305 describes a quantitative laboratory assay measuring human epididymis protein 4 (HE4) in serum, a tumor marker used in the evaluation of ovarian cancer. The test quantifies HE4 concentration to assist clinicians in assessing risk, monitoring disease, or supporting diagnostic workups.
Service Type: Laboratory test — quantitative tumor marker assay
Typical Site of Service: Clinical laboratory or hospital laboratory (ambulatory specimen collection or inpatient specimen processing)
Clinical & Coding Specifications
Clinical Context
A typical patient is a woman aged 45–75 presenting for evaluation of an adnexal mass, persistent pelvic pain, new pelvic fullness, or an abnormal transvaginal ultrasound. The clinician obtains a serum sample to measure human epididymis protein 4 (HE4) as an adjunct tumor marker for ovarian epithelial malignancy. The workflow: the provider orders 86305 on the laboratory requisition; phlebotomy is performed in an outpatient clinic, hospital lab, or ambulatory surgical center; the specimen is labeled and shipped to a clinical laboratory with validated HE4 assay methodology; a qualified laboratory analyst performs a quantitative immunoassay; results are routed to the ordering clinician and documented in the electronic health record. Results are interpreted in context with clinical findings and other markers (for example, CA-125) and imaging reports. Typical sites of service include hospital outpatient laboratory, independent clinical laboratory, ambulatory surgery center, and physician office-based phlebotomy. Common patient scenarios include surveillance after prior ovarian neoplasm, evaluation of a newly detected adnexal mass, or risk stratification in symptomatic patients.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing only the professional portion of laboratory interpretation when split billing applies. |
TC | Technical component | Use when billing only the technical component (laboratory processing) of the test. |
90 | Reference (outside) laboratory | Use when the test was performed by an outside laboratory and the billing provider is reporting results. |
91 | Repeat clinical diagnostic laboratory test | Use when a repeat quantitative HE4 test is performed on the same date to confirm a result. |
52 | Reduced services | Use when the lab procedure was partially reduced or not performed to full extent. |
53 | Discontinued procedure | Use when specimen collection or testing was started but discontinued for clinical reasons. |
59 | Distinct procedural service | Not in raw modifiers list; Data not available in the input. |
90 | Reference (outside) laboratory | Duplicate of above; Data not available in the input. |
91 | Repeat clinical diagnostic laboratory test | Duplicate of above; Data not available in the input. |
22 | Increased procedural services | Use when work or resources significantly exceed the usual for the test and documentation supports it. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Clinical Pathology | Laboratory directors and pathologists who oversee HE4 testing and validation. |
| 207K00000X | Anatomic and Clinical Pathology | Pathologists involved in diagnostic interpretation and reporting. |
| 207L00000X | Medical Laboratory Director | Clinical laboratory professionals responsible for assay quality and reporting. |
| 207KA0000X | Clinical Cytogenetics | Occasionally involved when tumor marker testing is part of broader oncologic evaluation. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C56.9 | Malignant neoplasm of ovary, unspecified | HE4 is used as a tumor marker in the evaluation and follow-up of ovarian epithelial carcinoma. |
N83.20 | Unspecified ovarian cyst | HE4 may be ordered in the workup of adnexal masses to assist risk stratification for malignancy. |
R10.2 | Pelvic and perineal pain | Symptomatic patients with pelvic pain may have HE4 measured as part of an ovarian pathology workup. |
R19.0 | Intra-abdominal and pelvic swelling, mass and lump | Presence of a pelvic mass on exam or imaging prompts tumor marker testing including HE4. |
Z85.43 | Personal history of malignant neoplasm of ovary | Surveillance with serum HE4 can be part of follow-up for patients with prior ovarian cancer. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
36415 | Collection of venous blood by venipuncture | Performed immediately before 86305 to obtain the serum specimen for HE4 testing. |
80053 | Comprehensive metabolic panel | Often ordered alongside tumor markers to assess baseline organ function prior to imaging or therapy. |
82652 | CA 125 (cancer antigen 125) | Commonly ordered concurrently with 86305 for ovarian cancer evaluation and risk assessment. |
88305 | Level IV surgical pathology, gross and microscopic examination | If an adnexal mass is surgically resected, pathology 88305 may follow HE4 testing in the diagnostic workflow. |
88342 | Immunohistochemistry (IHC) per single stain | May be used on tissue specimens when correlating serum tumor marker results with tissue markers. |