CPT® Code 81545

Official Description

Oncology (thyroid), gene expression analysis of 142 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (eg, benign or suspicious)

Common Language Description

The CPT® Code 81545 pertains to a specialized molecular genetic test focused on the analysis of thyroid tissue obtained through fine needle aspiration (FNA). This procedure involves the examination of messenger RNA (mRNA) expression levels of 142 specific genes simultaneously. Thyroid nodules, which are frequently encountered in clinical practice, necessitate thorough evaluation to ascertain their nature and potential risk for malignancy. The assessment typically includes a combination of clinical evaluation, measurement of thyrotropin (TSH) levels, ultrasound imaging, and, when indicated by the size and characteristics of the nodules, fine needle aspiration biopsy. In cases where the cytopathological classification of the FNA results is indeterminate, gene expression profiling can provide valuable insights. This profiling helps determine the positive percent agreement (PPA) and negative percent agreement (NPA) of the genes analyzed, thereby aiding in clinical decision-making. The results of this test are reported as a categorical outcome, indicating whether the findings are benign, with a greater than 95% NPA, or suspicious for malignancy, with a greater than 50% PPA. The primary utility of this gene expression analysis is to identify benign thyroid nodules preoperatively, which can significantly reduce the number of unnecessary surgical interventions for patients.

1. Indications

The procedure associated with CPT® Code 81545 is indicated for patients presenting with thyroid nodules that require further evaluation. The following conditions and scenarios warrant the use of this gene expression analysis:

Thyroid Nodules Patients with thyroid nodules that have been identified through clinical assessment and imaging studies, necessitating further investigation to determine their nature.
Indeterminate Cytopathology Individuals whose fine needle aspiration biopsy results are classified as indeterminate, where the cytological findings do not provide a definitive diagnosis of benign or malignant disease.
Preoperative Assessment Patients who may benefit from preoperative testing to avoid unnecessary surgical procedures, particularly those with a high likelihood of benign nodules based on gene expression profiling results.

2. Procedure

The procedure for CPT® Code 81545 involves several critical steps to ensure accurate gene expression analysis of thyroid tissue obtained via fine needle aspiration:

Sample Collection A fine needle aspiration is performed on the thyroid nodule to collect a sample of thyroid tissue. This minimally invasive procedure is guided by ultrasound to ensure precise targeting of the nodule.
RNA Extraction Once the sample is obtained, the messenger RNA (mRNA) is extracted from the collected cells. This step is crucial as it prepares the genetic material for subsequent analysis.
Gene Expression Analysis The extracted mRNA is then analyzed for the expression levels of 142 specific genes. This analysis is conducted using advanced molecular techniques that quantify the mRNA levels, providing insights into the biological behavior of the thyroid nodule.
Algorithm Scoring An algorithm is applied to the gene expression data to generate a categorical result. This score indicates whether the nodule is likely benign or suspicious for malignancy based on established thresholds for positive percent agreement (PPA) and negative percent agreement (NPA).
Result Reporting The final results are compiled and reported to the healthcare provider, detailing the categorical outcome of the analysis. This report aids in clinical decision-making regarding the management of the thyroid nodule.

3. Post-Procedure

After the gene expression analysis is completed, the healthcare provider will review the results with the patient. Depending on the outcome, further management may be recommended. If the result indicates a benign nodule, the patient may be monitored with regular follow-up imaging and clinical assessments. Conversely, if the result is suspicious for malignancy, additional diagnostic procedures or surgical intervention may be warranted. It is essential for patients to discuss the implications of the test results and the next steps in their care plan with their healthcare provider to ensure appropriate management of their thyroid condition.

Short Descr	ONCOLOGY THYROID
Medium Descr	ONCOLOGY THYROID GENE EXPRESSION 142 GENES
Long Descr	Oncology (thyroid), gene expression analysis of 142 genes, utilizing fine needle aspirate, algorithm reported as a categorical result (eg, benign or suspicious)
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	Not applicable/unspecified.