Summary & Overview
CPT 81316: PML/RARα (t(15;17)) Fusion Gene Detection
CPT code 81316 identifies a targeted molecular diagnostic assay for the PML/RARα (t(15;17)) fusion gene, a hallmark genetic rearrangement in acute promyelocytic leukemia. This code covers the laboratory technical procedure to detect and/or quantify the fusion resulting from breakpoints in intron 3 or intron 6. Nationally, precise coding for such molecular tests matters for clinical decision-making, therapy selection, and consistent reimbursement across payers.
Key payers included in this analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of the clinical context for the test, typical sites of service, and the service type. The publication also summarizes payer coverage patterns, common billing modifiers, and benchmarking considerations where available. Policy updates and coding guidance relevant to molecular diagnostic reporting are highlighted to support accurate claim submission and reporting.
This summary equips laboratory managers, billing professionals, and clinicians with the essential context needed to locate CPT code 81316 in billing workflows, understand its clinical purpose in diagnosing PML/RARα-associated leukemia, and identify where to look for payer-specific coverage rules and documentation requirements.
Billing Code Overview
CPT code 81316 describes a laboratory molecular diagnostic test that detects and/or quantifies the promyelocytic leukemia/retinoic acid receptor alpha fusion gene PML/RARα (t(15;17)). The test identifies the presence and amount of the specific fusion mutation formed from breakpoints in either intron 3 or intron 6, but not both.
Service type: Molecular pathology / targeted genetic assay
Typical site of service: Clinical molecular diagnostics laboratory
Clinical & Coding Specifications
Clinical Context
A 48-year-old patient presents to the hematology/oncology clinic with pancytopenia, circulating blasts on peripheral smear, and signs suggestive of acute promyelocytic leukemia (APL). Bone marrow aspiration and biopsy are performed; cytogenetics show a t(15;17) translocation suspicion or the morphology strongly suggests APL. A molecular laboratory order is placed for detection of the PML/RARalpha (t(15;17)) fusion transcript to confirm diagnosis, determine breakpoint type (intron 3 or intron 6), and guide therapy selection (including potential use of all-trans retinoic acid and arsenic trioxide). The typical clinical workflow: hematology orders the molecular test; specimen (bone marrow aspirate or peripheral blood) is collected and sent to a molecular diagnostics laboratory; a molecular technologist performs nucleic acid extraction and either RT-PCR or another validated assay targeting the PML/RARalpha fusion; results are interpreted by the laboratory director and reported to the ordering clinician. Typical site of service: hospital-based laboratory or independent molecular diagnostics lab associated with an outpatient oncology center. Typical patient scenario includes initial diagnostic workup for suspected APL, molecular confirmation after abnormal cytogenetics or flow cytometry, or molecular monitoring during or after therapy to assess minimal residual disease.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing only the professional (interpretation) component of the test when applicable and separated. |