Summary & Overview
CPT 0040U: MRDx BCR–ABL mRNA Test for CML Monitoring
CPT code 0040U is a Proprietary Laboratory Analyses (PLA) code for the MRDx® BCR–ABL assay from MolecularMD. The assay quantifies BCR–ABL mRNA transcripts (e13a2/b2a2 or e14a2/b3a2) with an ABL endogenous control to monitor response in chronic myelogenous leukemia. As a PLA code, 0040U uniquely identifies a single manufacturer’s test and supports clinical monitoring decisions for CML patients receiving targeted therapy.
Key national payers in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication summarizes payer coverage landscapes and benchmarking where available, with an emphasis on clinical utility, coding specificity, and implications for laboratory billing workflows.
Readers will learn the clinical context for molecular BCR–ABL monitoring, what the PLA designation means for coding and billing, and where to find payer policy details. The report provides benchmarks and policy summaries when available and notes areas where data are not provided in the input. The content is intended for laboratory billing managers, clinicians who oversee CML monitoring, and policy analysts tracking proprietary diagnostic codes.
Billing Code Overview
CPT code 0040U is a Proprietary Laboratory Analyses (PLA) code that describes a single proprietary molecular diagnostic assay: the MRDx® BCR–ABL test from MolecularMD. The test measures BCR–ABL mRNA transcripts (e13a2/b2a2 or e14a2/b3a2) and the ABL endogenous control mRNA to monitor patients with chronic myelogenous leukemia (CML).
Service type: Proprietary molecular diagnostic laboratory test (PLA)
Typical site of service: Clinical reference laboratory
Clinical & Coding Specifications
Clinical Context
A 52-year-old patient with a prior diagnosis of chronic myelogenous leukemia (CML) is seen in hematology/oncology clinic for routine molecular disease monitoring. The patient is stable on a tyrosine kinase inhibitor (TKI) therapy and requires quantitative assessment of BCR–ABL transcript levels to evaluate treatment response and detect molecular relapse. A peripheral blood draw is collected in an appropriate RNA-stabilizing tube and sent to a reference laboratory that performs the MRDx® BCR–ABL assay (Proprietary Laboratory Analysis code 0040U). The laboratory extracts RNA, performs reverse transcription and quantitative PCR targeting the BCR–ABL e13a2/e14a2 transcripts with ABL as the endogenous control, and reports the BCR–ABL/ABL ratio on the International Scale (IS) to guide clinical decisions during follow-up visits.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Standard reporting when no special modifier applies |
26 | Professional component | When reporting only the professional interpretation component separate from the technical component |