CPT® Code 81520

Official Description

Oncology (breast), mRNA gene expression profiling by hybrid capture of 58 genes (50 content and 8 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence risk score

Common Language Description

The CPT® Code 81520 pertains to a specialized molecular genomic testing procedure focused on breast cancer. This test involves mRNA gene expression profiling, which is a method used to analyze the expression levels of specific genes within a tumor sample. In this case, the test evaluates a total of 58 genes, comprising 50 content genes that are indicative of the tumor's characteristics and 8 housekeeping genes that serve as controls to ensure the accuracy of the results. The tissue used for this analysis is formalin-fixed paraffin-embedded breast tumor tissue, which is a common method for preserving biological samples for histological examination.

The primary purpose of this test is to provide a prognostic indicator for recurrence-free survival, particularly in post- and peri-menopausal women diagnosed with Stage I or II breast cancer. This includes patients with lymph node-negative disease as well as those with Stage II lymph node-positive disease involving 1 to 3 nodes, and who have hormone receptor-positive breast cancer. The test results are reported as a recurrence risk score (ROR score), which is generated through a combination of the gene expression data and clinical factors such as tumor type, size, and lymph node involvement. The ROR score categorizes the risk of cancer recurrence into three levels: low, intermediate, and high, based on specific score ranges for both node-negative and node-positive patients. This information is crucial for guiding treatment decisions and patient management strategies in oncology.

1. Indications

The mRNA gene expression profiling test described by CPT® Code 81520 is indicated for specific patient populations and clinical scenarios. The following conditions and characteristics are explicitly associated with the use of this test:

Post- and Peri-Menopausal Women The test is specifically designed for women in the post-menopausal or peri-menopausal stage of life.
Stage I or II Breast Cancer The procedure is applicable for patients diagnosed with Stage I or II breast cancer, which indicates the extent of tumor growth and spread.
Lymph Node Negative The test is indicated for patients with lymph node-negative breast cancer, meaning that the cancer has not spread to the lymph nodes.
Lymph Node Positive It is also indicated for patients with Stage II lymph node-positive breast cancer, specifically those with 1 to 3 affected lymph nodes.
Hormone Receptor Positive The test is relevant for patients whose breast cancer is hormone receptor-positive, indicating that the cancer cells grow in response to hormones.

2. Procedure

The procedure for conducting the mRNA gene expression profiling test involves several critical steps to ensure accurate results. Each step is essential for the successful analysis of the tumor tissue.

Histological Examination Initially, a pathologist examines histology slides prepared from the formalin-fixed paraffin-embedded breast tumor tissue. During this examination, the pathologist identifies and marks the tumor cells, ensuring that the correct areas of the tissue are selected for further analysis.
mRNA Isolation Following the histological examination, a technician isolates the mRNA from the marked tumor cells. This is accomplished using a specialized extraction kit designed to efficiently extract mRNA while preserving its integrity for subsequent analysis.
Data Analysis Once the mRNA is isolated, it undergoes analysis using a computer program. This program processes the gene expression data to produce a recurrence risk score (ROR score), which reflects the likelihood of cancer recurrence based on the expression levels of the analyzed genes.
Score Generation The ROR score is generated by combining the gene expression data with clinical information, including the type of cancer, tumor size, and lymph node status. This comprehensive approach allows for a nuanced understanding of the patient's prognosis.
Risk Categorization Finally, the ROR score is categorized into low, intermediate, or high risk for recurrence-free survival. For node-negative patients, scores of 0-40 indicate low risk, 41-60 indicate intermediate risk, and 61-100 indicate high risk. For node-positive patients, scores of 0-40 indicate low risk, while scores of 41-100 indicate high risk.

3. Post-Procedure

After the mRNA gene expression profiling test is completed, the results are compiled and reported to the healthcare provider. The recurrence risk score generated from the analysis serves as a critical tool for guiding treatment decisions. The healthcare provider will discuss the implications of the score with the patient, including potential treatment options and follow-up care based on the risk of recurrence. It is important for patients to understand the significance of their score in the context of their overall treatment plan and prognosis. Additionally, ongoing monitoring and follow-up appointments may be necessary to assess the patient's condition and response to treatment.

Short Descr	ONC BREAST MRNA 58 GENES
Medium Descr	ONC BREAST MRNA GENE XPRSN PRFL HYBRD 58 GENES
Long Descr	Oncology (breast), mRNA gene expression profiling by hybrid capture of 58 genes (50 content and 8 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a recurrence 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.