CPT® Code 81542

Official Description

Oncology (prostate), mRNA, microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as metastasis risk score

Common Language Description

The CPT® Code 81542 pertains to a specific molecular genetic test utilized in oncology, particularly for prostate cancer. This test involves the analysis of messenger RNA (mRNA) extracted from formalin-fixed paraffin-embedded (FFPE) prostate tissue samples. The primary objective of this testing is to evaluate the expression of 22 specific genes that are relevant to prostate cancer progression. By employing microarray gene expression profiling, the test quantifies the levels of mRNA present in the tissue, which provides insights into the biological behavior of the cancer. The results of this analysis are crucial for predicting the likelihood of metastasis, especially in patients who have undergone radical prostatectomy. The test is particularly indicated for patients diagnosed with Stage 2 prostate cancer who have positive surgical margins, Stage 3 disease, or those exhibiting rising prostate-specific antigen (PSA) levels post-surgery. The algorithm developed from the genetic data yields a metastasis risk score ranging from 0 to 1, which aids healthcare providers in assessing the risk of clinical metastasis in patients experiencing biochemical recurrence after surgical intervention. Additionally, this risk score can inform decisions regarding the timing of postoperative radiotherapy, thereby playing a significant role in the management and treatment planning for prostate cancer patients.

1. Indications

The CPT® Code 81542 is indicated for use in specific clinical scenarios related to prostate cancer. The following conditions warrant the performance of this molecular genetic test:

Stage 2 Disease with Positive Margins This test is often utilized for patients diagnosed with Stage 2 prostate cancer who have positive surgical margins, indicating that cancerous cells may remain after surgery.
Stage 3 Disease Patients with Stage 3 prostate cancer, which is characterized by more advanced disease, may also benefit from this testing to assess the risk of metastasis.
Rising PSA Levels Post-Surgery The test is indicated for any patient who exhibits rising prostate-specific antigen (PSA) levels following radical prostatectomy, as this may suggest a recurrence of the disease.

2. Procedure

The procedure for CPT® Code 81542 involves several critical steps to ensure accurate molecular genetic testing of prostate tissue. The following outlines the procedural steps:

Sample Collection A sample of formalin-fixed paraffin-embedded (FFPE) prostate tissue is collected, typically from a biopsy or surgical specimen. This tissue is preserved in formalin and embedded in paraffin to maintain its integrity for analysis.
RNA Extraction The mRNA is extracted from the FFPE tissue sample. This step is crucial as it isolates the genetic material necessary for subsequent analysis. The extraction process must be performed carefully to ensure the quality and quantity of the mRNA are sufficient for testing.
Microarray Gene Expression Profiling The extracted mRNA undergoes microarray gene expression profiling, which involves hybridizing the mRNA to a microarray that contains probes for the 22 content genes of interest. This step allows for the quantification of gene expression levels in the sample.
Algorithm Development An algorithm is created based on the expression levels of the 22 genes. This algorithm processes the genetic information to generate a metastasis risk score, which ranges from 0 to 1, indicating the likelihood of clinical metastasis.
Reporting Results The final step involves reporting the metastasis risk score to the healthcare provider. This score assists in clinical decision-making regarding the management of the patient's prostate cancer, including the potential need for postoperative radiotherapy.

3. Post-Procedure

After the completion of the molecular genetic testing associated with CPT® Code 81542, the healthcare provider will review the results, specifically the metastasis risk score. This score is instrumental in guiding further treatment decisions, including the timing and necessity of postoperative interventions such as radiotherapy. Patients may be monitored for any changes in their clinical status, particularly those with rising PSA levels, as this could indicate a recurrence of the disease. Ongoing follow-up and management strategies will be tailored based on the risk assessment provided by the test results, ensuring that each patient receives appropriate care based on their individual risk profile.

Short Descr	ONC PROSTATE MRNA 22 CNT GEN
Medium Descr	ONC PRST8 MRNA MICRORA GENE XPRSN PRFL 22 GENES
Long Descr	Oncology (prostate), mRNA, microarray gene expression profiling of 22 content genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as metastasis 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)	none
MUE	1

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.