Summary & Overview
CPT 0023U: LeukoStrat CDx FLT3 Mutation Assay
CPT code 0023U designates the LeukoStrat® CDx FLT3 Mutation Assay, a proprietary molecular pathology test that detects mutations in the FLT3 gene to inform treatment planning for patients with acute myelogenous leukemia (AML). As a PLA code, 0023U maps to a single manufacturer's test and is used for reporting the specific diagnostic service performed by Invivoscribe Technologies, Inc. The code matters nationally because FLT3 mutation status is a critical therapeutic and prognostic marker in AML care and influences targeted therapy eligibility and clinical decision-making.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield plans, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical context for FLT3 testing, the significance of a proprietary PLA code, and what to expect in payer coverage discussions. The publication provides benchmarks and comparative policy highlights, including how PLA coding affects billing specificity, common modifiers used when reporting lab services, and implications for laboratory and oncology service lines.
The report is intended for coding professionals, laboratory directors, oncology clinicians, and policy analysts seeking a national-level summary of the code's purpose, payer landscape, and operational considerations related to the use of a manufacturer-specific molecular diagnostic assay.
Billing Code Overview
CPT code 0023U is a Proprietary Laboratory Analyses (PLA) code that describes the LeukoStrat® CDx FLT3 Mutation Assay by Invivoscribe Technologies, Inc. The test is a molecular pathology assay designed to identify mutations in the FLT3 gene to aid treatment planning for patients with acute myelogenous leukemia (AML).
Service type: Molecular pathology / diagnostic laboratory testing
Typical site of service: Clinical laboratory or outpatient laboratory facility, often ordered by oncology providers and performed by the manufacturer's laboratory or certified diagnostic laboratories.
Clinical & Coding Specifications
Clinical Context
A 62-year-old patient with newly diagnosed acute myelogenous leukemia (AML) undergoes molecular profiling to guide initial therapy selection. The oncology team orders the LeukoStrat® CDx FLT3 Mutation Assay (0023U) on a peripheral blood or bone marrow specimen to detect activating FLT3 internal tandem duplications (ITD) and tyrosine kinase domain (TKD) mutations. The clinical workflow begins with specimen collection by the hematology/oncology clinic or inpatient team, accessioning at the hospital or reference laboratory, and performance of the proprietary PCR-based assay in the performing laboratory. Results are reported to the treating hematologist/oncologist and incorporated into treatment planning, such as selection of FLT3-targeted tyrosine kinase inhibitors, enrollment in targeted therapy clinical trials, or risk stratification for transplant referral. Typical sites of service include hospital outpatient departments, inpatient hospital settings, and independent clinical reference laboratories. Common interacting providers include hematologist/oncologists, pathologists, oncology nurses, and laboratory molecular technologists.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Not a valid modifier for professional billing; placeholder | Data not applicable for separate reporting; not used clinically |
11 | Normal, uncomplicated service | Rarely applied to PLA laboratory codes; not typically used for