Summary & Overview
CPT 81315: PML/RARalpha (t(15;17)) Fusion Detection and Quantification
CPT code 81315 represents a molecular diagnostic assay to detect and quantify the PML/RARalpha (t(15;17)) fusion gene, a hallmark genetic alteration in acute promyelocytic leukemia. This code captures the technical laboratory work required to identify common fusion breakpoints, including those on introns 3 and 6, and is critical for diagnosis, risk stratification, and monitoring of minimal residual disease. Nationally, availability of accurate molecular testing supports timely diagnostic confirmation and guides targeted therapy decisions.
Key payers in the scope of this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of clinical context for the assay, payer coverage considerations, and coding and billing implications tied to laboratory molecular diagnostics. The publication summarizes common billing modifiers and service settings, explains how CPT code 81315 fits into laboratory service lines, and outlines typical situations in which the test is medically relevant. Data not available in the input is noted where necessary. This executive summary provides clinicians, laboratory managers, and revenue cycle professionals with a concise national perspective on the role and billing context of CPT code 81315.
Billing Code Overview
CPT code 81315 describes a laboratory test performed by a lab analyst to detect and/or quantify the PML/RARalpha (promyelocytic leukemia/retinoic acid receptor alpha) fusion resulting from the t(15;17) translocation. The assay targets common breakpoints in the gene sequence, including those on introns 3 and 6, to evaluate the presence and amount of the PML/RARalpha mutation.
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Service type: Molecular diagnostic test for detection and quantification of a disease-defining fusion gene.
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Typical site of service: Hospital or independent clinical laboratory molecular diagnostics department; may also be performed in specialized reference laboratories.
Clinical & Coding Specifications
Clinical Context
A 47-year-old patient presents with symptoms suggestive of acute promyelocytic leukemia (APL) including fatigue, easy bruising, and thrombocytopenia on complete blood count. The hematologist orders molecular testing to detect the PML/RARalpha fusion transcript associated with the t(15;17) translocation. A peripheral blood or bone marrow specimen is collected in an appropriate transport tube and sent to a clinical molecular diagnostics laboratory. The lab analyst performs a targeted nucleic acid test (such as reverse transcription PCR or quantitative PCR) to evaluate the presence and/or amount of the PML/RARalpha fusion resulting from common breakpoints in introns 3 and 6. Results are interpreted and reported to the ordering hematologist/oncologist and included in the medical record to guide diagnosis, induction therapy decisions (for example, use of all-trans retinoic acid), risk stratification, and minimal residual disease monitoring during and after therapy. Typical sites of service include hospital inpatient laboratories, outpatient hospital laboratories, and independent reference molecular diagnostic laboratories.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | When reporting only the physician interpretation component of the molecular test separated from the technical component |
TC |