2025 CPT code 81278
Effective Date: N/A Pathology and Laboratory - Molecular Pathology Procedures Feed
IGH@/BCL2 (t(14;18)) (eg, follicular lymphoma) translocation analysis, major breakpoint region (MBR) and minor cluster region (mcr) breakpoints, qualitative or quantitative.
Modifier 26 can be applied if the provider performs only the professional component (interpretation and report) of the test. Modifier 59 may be applicable in certain distinct procedural service scenarios.
Medical necessity for 81278 is established when the test is used to diagnose follicular lymphoma, monitor the effectiveness of treatment, or detect minimal residual disease in patients with a confirmed diagnosis or history of follicular lymphoma. The test results must directly impact the patient's treatment plan. Payer-specific medical necessity criteria should be consulted.
The laboratory professional performs the technical aspects of this test, which includes extracting DNA from the patient's sample, processing the DNA to amplify the target regions, and then analyzing the DNA to detect the presence or quantity of the translocation.
In simple words: This test analyzes a patient's DNA to look for a specific genetic change called the IGH@/BCL2 (t(14;18)) translocation, which is linked to a type of cancer called follicular lymphoma. The test checks two specific areas of the DNA related to this translocation, called the major breakpoint region (MBR) and the minor cluster region (mcr). The results can either show whether the translocation is present or measure the amount of it in the sample. This information helps doctors diagnose follicular lymphoma, track how well treatment is working, and see if any cancer remains after treatment.
This code represents a molecular pathology procedure involving the analysis of nucleic acid (DNA) to detect the IGH@/BCL2 (t(14;18)) translocation, specifically examining both the major breakpoint region (MBR) and minor cluster region (mcr) breakpoints. This test is either qualitative, determining the presence or absence of the translocation, or quantitative, measuring the amount of the translocation present. It is often used in the context of follicular lymphoma diagnosis, monitoring treatment response, or detecting minimal residual disease.
Example 1: A patient presents with swollen lymph nodes and other symptoms suggestive of lymphoma. A biopsy is performed, and 81278 is ordered on the biopsied tissue to determine if the IGH@/BCL2 translocation is present, which would support a diagnosis of follicular lymphoma., A patient with follicular lymphoma has completed a course of chemotherapy. Code 81278 is used to monitor the patient's response to therapy by quantifying the level of the IGH@/BCL2 translocation. A decrease or disappearance of the translocation suggests a positive response to treatment., A patient with a history of follicular lymphoma is in remission. 81278 can be used to detect minimal residual disease, where small amounts of cancer cells containing the translocation may persist even when the disease is clinically undetectable. This information can help guide treatment decisions and predict the likelihood of relapse.
Documentation should include the type of specimen submitted, the reason for testing (e.g., initial diagnosis, monitoring therapy, minimal residual disease detection), and the results of the analysis, which may be reported as positive/negative (qualitative) or as a numerical value (quantitative). Supporting clinical documentation related to the suspected or confirmed follicular lymphoma is also important. Pathologist's interpretation report should be included.
- Specialties:Pathology, Hematology/Oncology
- Place of Service:Independent Laboratory, Office, Inpatient Hospital, On Campus-Outpatient Hospital, Off Campus-Outpatient Hospital