CPT® Code 81539

Official Description

Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA, and human kallikrein-2 [hK2]), utilizing plasma or serum, prognostic algorithm reported as a probability score

Common Language Description

The CPT® Code 81539 pertains to a biochemical assay specifically designed for the assessment of high-grade prostate cancer. This assay evaluates four key proteins: Total PSA (tPSA), Free PSA (fPSA), Intact PSA (iPSA), and human kallikrein-2 (hK2). These proteins are measured in either plasma or serum samples obtained from the patient. Prostate-specific antigen (PSA) is a glycoprotein enzyme that is part of the kallikrein family and is secreted by the epithelial cells of the prostate gland. Elevated levels of PSA in the plasma or serum can indicate various conditions, including benign prostatic hypertrophy, prostatitis, and potential malignancy. Human kallikrein-2 (hK2) is another protein secreted by the prostate gland, and its elevated levels are more closely associated with malignant prostate tumors, which can vary in aggressiveness and potential for metastasis. The assay involves obtaining a blood sample through a procedure known as venipuncture, which is separately reportable. The serum or plasma is then analyzed using an electrochemiluminescence immunoassay, a sensitive technique that allows for the precise measurement of these proteins. The results from this blood test are integrated into a prognostic algorithm that takes into account the patient's age, the presence or absence of prostate nodules detected during a digital rectal exam (DRE), and any prior negative biopsy results. This algorithm generates a probability score that indicates the likelihood of finding high-grade prostate cancer, defined as a Gleason score of 7 or higher, upon biopsy. The reported probability score serves as a valuable tool for both the physician and the patient, aiding in the decision-making process regarding the necessity of proceeding with a prostate biopsy. However, it is important to note that this test is contraindicated for patients who have a previous diagnosis of prostate cancer, have undergone a DRE within the last four days, are receiving 5-alpha reductase inhibitor therapy, or have been treated for symptomatic benign prostatic hypertrophy within the past six months.

1. Indications

The CPT® Code 81539 is indicated for use in the assessment of patients who may be at risk for high-grade prostate cancer. The following conditions and symptoms warrant the performance of this biochemical assay:

Elevated PSA Levels: Patients presenting with elevated levels of prostate-specific antigen (PSA) in their plasma or serum.
Prostate Nodules: Patients who have undergone a digital rectal exam (DRE) that indicates the presence of prostate nodules.
Age Considerations: The patient's age is a factor in determining the risk of high-grade prostate cancer.
Prior Negative Biopsy: Patients with a history of prior negative biopsy results who may require further evaluation for prostate cancer risk.

2. Procedure

The procedure for CPT® Code 81539 involves several critical steps to ensure accurate assessment of the risk for high-grade prostate cancer:

Step 1: Patient Preparation The patient is prepared for the procedure, which includes obtaining informed consent and explaining the purpose of the blood test. It is essential to ensure that the patient has not undergone a DRE within the last four days, is not on 5-alpha reductase inhibitors, and has not received treatment for symptomatic benign prostatic hypertrophy within the past six months.
Step 2: Blood Sample Collection A blood sample is obtained through a procedure known as venipuncture. This step is crucial as it provides the serum or plasma needed for the assay. The sample must be collected in a manner that minimizes contamination and ensures the integrity of the specimen.
Step 3: Laboratory Analysis The collected serum or plasma is subjected to an electrochemiluminescence immunoassay. This advanced testing method allows for the precise measurement of the four proteins: Total PSA, Free PSA, Intact PSA, and human kallikrein-2 (hK2).
Step 4: Algorithm Application The results from the assay are then integrated into a prognostic algorithm. This algorithm considers the patient's age, the presence or absence of prostate nodules from the DRE, and any prior negative biopsy results to calculate a probability score.
Step 5: Reporting Results The final step involves reporting the probability score to the physician. This score indicates the likelihood of high-grade prostate cancer being present, which can assist in making informed decisions regarding the need for a prostate biopsy.

3. Post-Procedure

After the procedure associated with CPT® Code 81539, the patient may experience minimal discomfort from the venipuncture. There are no specific post-procedure care requirements related to the assay itself; however, the physician should discuss the results with the patient once they are available. The probability score generated from the assay can guide further diagnostic steps, including the potential need for a prostate biopsy. It is essential for the physician to monitor the patient for any signs of complications related to the blood draw and to provide appropriate follow-up based on the assay results and the patient's overall clinical picture.

Short Descr	ONCOLOGY PROSTATE PROB SCORE
Medium Descr	ONCOLOGY PROSTATE BIOCHEMICAL ASSAY 4 PROTEINS
Long Descr	Oncology (high-grade prostate cancer), biochemical assay of four proteins (Total PSA, Free PSA, Intact PSA, and human kallikrein-2 [hK2]), utilizing plasma or serum, prognostic algorithm reported as a probability 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)	T2D - Other tests - other
MUE	1

GZ	Item or service expected to be denied as not reasonable and necessary
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.