2025 CPT code 81316
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; single breakpoint (eg, intron 3, intron 6 or exon 6), qualitative or quantitative. (For intron 3 and intron 6 [including exon 6 if performed] analysis, use 81315). (If both intron 6 and exon 6 are analyzed, without intron 3, use one unit of 81316)
Modifier 26 can be appended to the code if only the professional component (interpretation and report) is performed by a physician or other qualified healthcare professional.
Medical necessity for this test is established by the patient's clinical presentation and the suspicion of APL. It is also medically necessary for monitoring response to therapy and detecting minimal residual disease in patients with APL.
The laboratory analyst performs the technical aspects of the test, including cell lysis, nucleic acid extraction, amplification, and detection of the gene fusion. Interpretation of the results is typically performed by a physician or other qualified healthcare professional.
In simple words: This test looks for a specific gene change called PML/RARalpha that is commonly found in a type of leukemia called acute promyelocytic leukemia (APL). It helps doctors diagnose APL by checking for a specific part of this gene change.
This code represents a molecular pathology procedure for analyzing the PML/RARalpha gene fusion, which is a characteristic marker for acute promyelocytic leukemia (APL). It involves testing for a single breakpoint in either intron 3 or intron 6 (or exon 6 if performed) of the gene. The analysis can be either qualitative, determining the presence or absence of the fusion gene, or quantitative, measuring the amount of the fusion gene present.
Example 1: A patient presents with symptoms suggestive of APL, such as fatigue, bruising, and infections. This test is ordered to confirm the diagnosis by detecting the PML/RARalpha fusion gene., A patient with known APL is undergoing treatment. This test is used to monitor the response to therapy by measuring the levels of the PML/RARalpha fusion gene., A patient has achieved remission from APL. This test can be used to monitor for minimal residual disease (MRD) and help guide decisions about further treatment or surveillance.
Documentation should include the patient's clinical history, reason for testing, and the specific breakpoint being analyzed. The laboratory report should include details of the methodology used, the results of the analysis (qualitative or quantitative), and the interpretation of the findings.
- Specialties:Hematology, Oncology, Pathology
- Place of Service:Independent Laboratory, Hospital Laboratory