CPT® Code 81595

Official Description

Cardiology (heart transplant), mRNA, gene expression profiling by real-time quantitative PCR of 20 genes (11 content and 9 housekeeping), utilizing subfraction of peripheral blood, algorithm reported as a rejection risk score

Common Language Description

The CPT® Code 81595 pertains to a specialized diagnostic procedure known as gene expression profiling, specifically within the context of cardiology and heart transplantation. This procedure utilizes a subfraction of peripheral blood to assess the expression levels of 20 specific genes, which include 11 genes associated with transplant rejection and 9 housekeeping genes that serve as controls. The primary aim of this test is to detect acute heart transplant rejection or the onset of graft dysfunction, providing critical information that can guide clinical decision-making. Gene expression profiling involves analyzing how genetic information is translated into functional proteins or mRNA, thereby indicating which genes are actively expressed (producing mRNA or proteins) and which are not (not producing mRNA or proteins) in the blood sample. The testing process employs real-time quantitative polymerase chain reaction (RT-PCR) technology to quantify the expression levels of these genes. The results are then processed through a computer algorithm that evaluates the contribution of each gene to the overall assessment, culminating in a rejection risk score. This score can be instrumental in conjunction with other diagnostic methods, such as endomyocardial biopsy, to tailor immunosuppressant therapy based on the graft's functional status and the degree of acute cellular rejection.

1. Indications

The gene expression profiling test represented by CPT® Code 81595 is indicated for the following conditions:

Acute Heart Transplant Rejection This test is utilized to detect the presence of acute rejection episodes in patients who have undergone heart transplantation.
Graft Dysfunction The procedure may also be performed to identify the development of graft dysfunction, which can occur post-transplantation.
Immunosuppressant Drug Dosage Adjustment The results from this test can assist in adjusting the dosage of immunosuppressant medications based on the functional status of the graft and the grade of acute cellular rejection.

2. Procedure

The procedure for gene expression profiling as described by CPT® Code 81595 involves several key steps:

Sample Collection A peripheral blood sample is obtained from the patient. This step is crucial as it provides the biological material needed for the analysis of gene expression.
Gene Analysis The collected blood sample is subjected to real-time quantitative polymerase chain reaction (RT-PCR) testing. This technique allows for the quantification of the expression levels of 20 specific genes, which includes 11 genes known to be associated with transplant rejection and 9 housekeeping genes that serve as controls.
Data Processing The results from the RT-PCR are analyzed using specialized computer software. This software processes the expression data to evaluate the contribution of each gene in the panel.
Rejection Risk Score Reporting The final output of the analysis is a rejection risk score, which is reported as a single numerical value. This score reflects the likelihood of acute rejection based on the gene expression profile obtained from the blood sample.

3. Post-Procedure

After the gene expression profiling procedure, the patient may not require any specific post-procedure care related to the blood sample collection itself. However, it is essential for healthcare providers to interpret the rejection risk score in conjunction with other clinical findings and diagnostic tests, such as endomyocardial biopsy. The results may lead to adjustments in the patient's immunosuppressant therapy to optimize graft function and minimize the risk of rejection. Continuous monitoring and follow-up are recommended to ensure the patient's health and the proper functioning of the transplanted organ.

Short Descr	CARDIOLOGY HRT TRNSPL MRNA
Medium Descr	CARDIOLOGY HRT TRNSPL MRNA GENE EXPRESS 20 GENES
Long Descr	Cardiology (heart transplant), mRNA, gene expression profiling by real-time quantitative PCR of 20 genes (11 content and 9 housekeeping), utilizing subfraction of peripheral blood, algorithm reported as a rejection 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)	T1H - Lab tests - other (non-Medicare fee schedule)
MUE	1