2025 CPT code 81315
Effective Date: N/A Pathology and Laboratory Procedures - Molecular Pathology Procedures Feed
PML/RARalpha,(t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (eg, promyelocytic leukemia) translocation analysis; common breakpoints (eg, intron 3 and intron 6), qualitative or quantitative
Modifier 26 can be appended if only the professional component (interpretation and report) is performed by the physician.
Medical necessity is established by the patient's clinical presentation and the need to diagnose or monitor APL.
The laboratory analyst performs the technical aspects of this test, including DNA extraction, amplification, and detection of the gene fusion.
In simple words: This test looks for a specific gene change called PML/RARalpha, which is often found in a type of leukemia.It tells the doctor whether the gene change is present and how much of it there is.
This code represents a laboratory procedure for the analysis of the PML/RARalpha gene fusion, which is a translocation between chromosomes 15 and 17. This fusion gene is commonly associated with acute promyelocytic leukemia (APL). The analysis includes testing for common breakpoints within introns 3 and 6 of the gene and can be either qualitative (determining presence or absence) or quantitative (measuring the amount of fusion gene present).
Example 1: A patient presents with symptoms suggestive of acute promyelocytic leukemia (APL). This test is ordered to confirm the diagnosis by detecting the presence of the PML/RARalpha fusion gene., A patient with known APL is undergoing treatment. This test is used to monitor the effectiveness of the therapy by quantifying the amount of PML/RARalpha fusion gene present., A patient in remission from APL is being monitored for relapse. This test is ordered periodically to detect the reappearance of PML/RARalpha, which could indicate disease recurrence.
Documentation should include the patient's clinical history, reason for testing, and the specific type of analysis performed (qualitative or quantitative).
** The presence of this fusion gene is a hallmark of acute promyelocytic leukemia (APL). The test is crucial for accurate diagnosis, treatment selection, and disease monitoring.
- Modifier TC rule: Modifier TC is not applicable to this code as it is not specific for only the technical component of the testing.
- Place of Service:Independent Laboratory, On Campus-Outpatient Hospital