CPT® Code 81500

Official Description

Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score

Common Language Description

The CPT® Code 81500 pertains to a specific set of biochemical assays utilized in the field of oncology, particularly for evaluating the risk of ovarian cancer in women presenting with pelvic or ovarian masses. This procedure involves the measurement of two critical protein markers: Cancer Antigen 125 (CA-125) and Human Epididymis Protein 4 (HE4). The test is designed to assess the likelihood of malignancy based on these biomarkers, which are analyzed in conjunction with the patient's menopausal status and age. The results are reported as a risk score through a method known as the Risk of Ovarian Malignancy Algorithm (ROMA). The testing process begins with the collection of a blood sample, which is obtained through a procedure known as venipuncture. The serum extracted from this sample undergoes two distinct assays: CA-125 is measured using a quantitative electrochemiluminescent immunoassay, while HE4 is assessed through a quantitative enzyme immunoassay. The combination of these tests provides valuable diagnostic information that aids healthcare professionals in determining the risk of ovarian cancer, thereby guiding further clinical decision-making. This procedure is particularly significant for women who exhibit symptoms or findings suggestive of ovarian pathology, as it helps in stratifying their risk and planning appropriate management strategies.

1. Indications

The procedure associated with CPT® Code 81500 is indicated for women who present with specific symptoms or conditions that may suggest the presence of ovarian cancer. The following are the explicitly provided indications for performing this biochemical assay:

Pelvic or Ovarian Mass: Women presenting with a pelvic or ovarian mass are evaluated to assess their risk for ovarian cancer.

2. Procedure

The procedure for CPT® Code 81500 involves several critical steps to ensure accurate measurement of the biomarkers CA-125 and HE4. The following outlines the procedural steps:

Step 1: Patient Preparation and Blood Sample Collection The patient is prepared for the procedure, which includes obtaining informed consent. A blood sample is collected through venipuncture, a standard method for drawing blood. This step is crucial as it provides the serum needed for subsequent testing.
Step 2: Serum Testing for CA-125 The serum obtained from the blood sample is tested for the presence of Cancer Antigen 125 (CA-125). This is accomplished using a quantitative electrochemiluminescent immunoassay, a sensitive and specific method that quantifies the level of CA-125 in the serum.
Step 3: Serum Testing for HE4 In addition to CA-125, the serum is also tested for Human Epididymis Protein 4 (HE4). This measurement is performed using a quantitative enzyme immunoassay, which allows for the accurate determination of HE4 levels in the serum.
Step 4: Risk Score Calculation After both biomarkers have been measured, the results are analyzed in conjunction with the patient's age and menopausal status. This information is utilized to calculate a risk score through the Risk of Ovarian Malignancy Algorithm (ROMA), which provides a predictive assessment of the likelihood of ovarian cancer.

3. Post-Procedure

Post-procedure care for patients undergoing the CPT® Code 81500 assay typically involves monitoring for any immediate complications related to the venipuncture, such as bruising or discomfort at the site of blood draw. Patients may be advised to follow up with their healthcare provider to discuss the results of the assay and any further diagnostic or therapeutic steps that may be necessary based on the risk score obtained. It is essential for healthcare professionals to interpret the results in the context of the patient's overall clinical picture and to consider additional imaging or referral to an oncologist if indicated.

Short Descr	ONCO (OVAR) TWO PROTEINS
Medium Descr	ONCO (OVARIAN) BIOCHEMICAL ASSAY TWO PROTEINS
Long Descr	Oncology (ovarian), biochemical assays of two proteins (CA-125 and HE4), utilizing serum, with menopausal status, algorithm reported as a risk score
Status Code	Statutory Exclusion (from MPFS, may be paid under other methodologies)
Global Days	XXX - Global Concept Does Not Apply
PC/TC Indicator (26, TC)	9 - Not Applicable
Multiple Procedures (51)	9 - Concept does not apply.
Bilateral Surgery (50)	9 - Concept does not apply.
Physician Supervisions	09 - Concept does not apply.
Assistant Surgeon (80, 82)	9 - Concept does not apply.
Co-Surgeons (62)	9 - Concept does not apply.
Team Surgery (66)	9 - Concept does not apply.
Diagnostic Imaging Family	99 - Concept Does Not Apply
CLIA Waived (QW)	No
APC Status Indicator	Service Paid under Fee Schedule or Payment System other than OPPS
Type of Service (TOS)	5 - Diagnostic Laboratory
Berenson-Eggers TOS (BETOS)	T1H - Lab tests - other (non-Medicare fee schedule)
MUE	1
CCS Clinical Classification	234 - Pathology

90	Reference (outside) laboratory: when laboratory procedures are performed by a party other than the treating or reporting physician or other qualified health care professional, the procedure may be identified by adding modifier 90 to the usual procedure number.
GZ	Item or service expected to be denied as not reasonable and necessary