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Official Description

Oncology (breast), mRNA, gene expression profiling by RT-PCR of 12 genes (8 content and 4 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence risk score

© Copyright 2026 American Medical Association. All rights reserved.

Common Language Description

The CPT® Code 81522 pertains to a specific molecular genetic test utilized in oncology, particularly for breast cancer. This test involves the analysis of messenger RNA (mRNA) extracted from formalin-fixed paraffin-embedded (FFPE) tissue samples obtained from breast tumors. The primary objective of this testing is to evaluate the expression of 12 specific genes, which include 8 content genes that are directly related to cancer progression and 4 housekeeping genes that serve as controls to ensure the accuracy of the test results. By employing reverse transcriptase-polymerase chain reaction (RT-PCR) technology, the test quantifies the levels of mRNA present in the tissue sample at a specific point in time. This quantification is crucial as it aids in determining the current status of the disease and provides insights into the likelihood of disease recurrence. The results of this test are interpreted through an algorithm that generates a recurrence risk score, which ranges from 1 to 100. This score categorizes patients into different risk levels: a score of less than 39 indicates a low risk of recurrence, scores between 39 and 54 suggest an intermediate risk, and scores of 55 or higher signify a high risk for recurrence. The test is particularly recommended for patients diagnosed with ductal carcinoma in situ (DCIS), as it assists healthcare providers in making informed decisions regarding treatment options and management strategies based on the predicted risk of recurrence.

© Copyright 2026 Coding Ahead. All rights reserved.

1. Indications

The CPT® Code 81522 is indicated for use in patients diagnosed with ductal carcinoma in situ (DCIS). This molecular genetic test is performed to assess the risk of disease recurrence in these patients, providing critical information that can influence treatment decisions and management strategies.

  • Ductal Carcinoma In Situ (DCIS) This test is specifically recommended for patients diagnosed with DCIS, a non-invasive form of breast cancer, to evaluate the likelihood of recurrence.

2. Procedure

The procedure for CPT® Code 81522 involves several key steps that ensure accurate assessment of mRNA expression in breast tumor tissue. First, a sample of formalin-fixed paraffin-embedded (FFPE) tissue is obtained from the patient's breast tumor. This tissue is then processed to extract the mRNA, which is crucial for the subsequent analysis. The extraction process must be performed with precision to ensure that the mRNA is intact and representative of the tumor's genetic profile. Next, the extracted mRNA undergoes reverse transcriptase-polymerase chain reaction (RT-PCR). This technique amplifies the mRNA, allowing for the quantification of the expression levels of the 12 targeted genes—8 content genes that are relevant to cancer progression and 4 housekeeping genes that serve as controls. The RT-PCR process is critical as it provides a snapshot of the gene expression at a specific point in time, reflecting the current status of the disease. Following the amplification, the results are analyzed using a specific algorithm that integrates the expression data to generate a recurrence risk score. This score, which ranges from 1 to 100, categorizes the patient's risk of recurrence into three distinct levels: low risk (score <39), intermediate risk (score 39-54), and high risk (score ≥55). This scoring system is essential for guiding treatment decisions and patient management.

  • Sample Collection A sample of formalin-fixed paraffin-embedded (FFPE) tissue is obtained from the breast tumor for analysis.
  • mRNA Extraction The mRNA is extracted from the FFPE tissue, ensuring it is intact and representative of the tumor's genetic profile.
  • RT-PCR Analysis The extracted mRNA undergoes reverse transcriptase-polymerase chain reaction (RT-PCR) to amplify and quantify the expression levels of the 12 targeted genes.
  • Recurrence Risk Score Calculation An algorithm analyzes the expression data to generate a recurrence risk score, categorizing the patient's risk of recurrence.

3. Post-Procedure

After the completion of the molecular genetic testing associated with CPT® Code 81522, the results, including the recurrence risk score, are reported to the healthcare provider. This information is crucial for guiding further treatment decisions and patient management. Patients may require follow-up consultations to discuss the implications of their risk score and to determine the most appropriate treatment options based on their individual risk of recurrence. Additionally, healthcare providers may consider the recurrence risk score in conjunction with other clinical factors to develop a comprehensive treatment plan tailored to the patient's specific needs.

Short Descr ONC BREAST MRNA 12 GENES
Medium Descr ONCOLOGY BREAST MRNA GENE XPRSN PRFL 12 GENES
Long Descr Oncology (breast), mRNA, gene expression profiling by RT-PCR of 12 genes (8 content and 4 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as 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
GY Item or service statutorily excluded, does not meet the definition of any medicare benefit or, for non-medicare insurers, is not a contract benefit
GZ Item or service expected to be denied as not reasonable and necessary
Date
Action
Notes
2020-01-01 Added Code added.
Code
Description
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