CPT® Code 81539

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

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.