CPT® Code 81313

Official Description

PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related peptidase 3 [prostate specific antigen]) ratio (eg, prostate cancer)

Common Language Description

The CPT® Code 81313 refers to a specific molecular genetic test that evaluates the ratio of PCA3 (prostate cancer antigen 3) to KLK3 (kallikrein-related peptidase 3, also known as prostate-specific antigen or PSA). This test is particularly relevant for men over the age of 50 who have undergone one or more negative prostate biopsies. The primary purpose of this test is to assist healthcare providers in determining whether a repeat biopsy is necessary. The PCA3 biomarker is a non-protein coding RNA that is often found in higher concentrations in malignant prostate cells compared to benign cells, making it a valuable tool for prostate cancer diagnosis. In contrast, KLK3 (PSA) is produced by both malignant and benign prostate cells, which allows for a comparative analysis between the two markers. The test involves collecting a urine sample after a digital rectal exam (DRE), where the prostate is palpated to assess its condition. The first 20-30 ml of voided urine is then analyzed using quantitative nucleic acid amplification techniques to measure the levels of PCA3 and PSA RNA. The results are expressed as a ratio, providing insights into the likelihood of prostate cancer presence, thereby aiding in risk prediction and prognosis for the patient.

1. Indications

The PCA3/KLK3 ratio test is indicated for use in specific clinical scenarios, particularly for men who meet the following criteria:

Age Over 50 Men aged 50 years and older are the primary candidates for this test, as prostate cancer risk increases with age.
Negative Prostate Biopsies The test is specifically designed for individuals who have had one or more negative prostate biopsies, indicating that previous tests have not confirmed the presence of cancer.

2. Procedure

The procedure for obtaining the PCA3/KLK3 ratio involves several key steps that ensure accurate results:

Digital Rectal Exam (DRE) A digital rectal exam is performed by the physician, where each lobe of the prostate is stroked three times. This examination helps assess the prostate's condition and may stimulate the release of PCA3 into the urine.
Urine Collection Following the DRE, the first 20-30 ml of voided urine is collected. This urine sample is critical as it contains the genetic material necessary for the subsequent analysis.
RNA Testing The collected urine is subjected to quantitative nucleic acid amplification techniques to measure the levels of PCA3 RNA and PSA RNA. This involves using reverse transcriptase to create DNA copies of the target RNA, followed by RNA polymerase to duplicate these RNA copies through transcription-mediated amplification.
Detection of Amplification Chemiluminescence-labeled probes are utilized to detect the amount of amplification present in the sample. This step is essential for quantifying the levels of PCA3 and PSA RNA.
Calculation of Ratio The final score is derived from the calculation of the ratio of PCA3 RNA copies to PSA RNA copies. This ratio provides valuable information regarding the likelihood of prostate cancer.

3. Post-Procedure

After the procedure, there are no specific post-procedure care requirements mentioned. However, it is important for the physician to discuss the results of the PCA3/KLK3 ratio test with the patient, as these results will inform the decision-making process regarding the need for further diagnostic procedures, such as repeat biopsies. Patients may be advised to follow up with their healthcare provider to review the findings and discuss any necessary next steps based on the test results.

Short Descr	PCA3/KLK3 ANTIGEN
Medium Descr	PCA3/KLK3 PROSTATE SPECIFIC ANTIGEN RATIO
Long Descr	PCA3/KLK3 (prostate cancer antigen 3 [non-protein coding]/kallikrein-related peptidase 3 [prostate specific antigen]) ratio (eg, prostate cancer)
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