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 |
TC | Technical component | When reporting only the technical laboratory component |
59 | Data not provided; not in list | Data not provided; not in list |
62 | Two surgeons — Data not applicable | Data not provided; not in list |
52 | Reduced services | When the test is partially performed or limited by specimen integrity |
53 | Discontinued procedure | If specimen collection or testing was started but discontinued for valid clinical reasons |
77 | Data not provided; not in list | Data not provided; not in list |
80 | Assistant surgeon — Data not applicable | Data not provided; not in list |
QX | Ordering/servicing laboratory modifier (Modifier indicating CLIA-waived or specific reporting) | When a separate independent laboratory performed components under a contractual arrangement; used per payer policy to identify performing lab |
QY | Intrastate rural health center — Data not applicable | Data not provided; not in list |
AD | Payer mandated diagnostic relatedness | When a payer requires a specific payer-association modifier (rare; follow payer rules) |
AS | Physician assistant, nurse practitioner, or clinical nurse specialist services | When the specimen was collected or associated services were provided by these practitioners as allowed by payer policy |
22 | Unusual procedural services | When work or complexity substantially exceeds typical requirements for the test (rare for PLA codes; document justification) |
52 | Reduced services | When only part of the assay panel was completed due to sample limitations (duplicate entry indicates clinical relevance) |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207RH0000X | Hematology | Hematologists order and interpret MRD monitoring for CML |
207RI0003X | Medical Oncology | Medical oncologists manage systemic therapy and use molecular monitoring |
363A00000X | Clinical Laboratory Scientist | Laboratory professionals perform molecular diagnostic testing |
208D00000X | Pathology | Pathologists may oversee molecular laboratory testing and result interpretation |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
C92.1 | Chronic myelogenous leukemia [CML] | Primary indication for serial BCR–ABL transcript monitoring to assess treatment response and minimal residual disease |
C92.10 | Chronic myelogenous leukemia not having achieved remission | Used when ongoing disease activity is present; monitoring guides therapy adjustments |
C92.11 | Chronic myelogenous leukemia in remission | Used to document remission status while continuing surveillance with molecular testing |
D47.Z2 | Chronic myeloproliferative disease, unspecified | Used when a myeloproliferative neoplasm is suspected and BCR–ABL testing helps distinguish CML from other entities |
Z51.11 | Encounter for antineoplastic chemotherapy | Used in patients receiving TKI therapy where molecular monitoring is part of treatment surveillance |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0040U | MRDx® BCR–ABL test — quantitative measurement of BCR–ABL and ABL mRNA for CML monitoring | Primary proprietary laboratory analysis code describing this specific assay |
81206 | BCR-ABL1; quantification of BCR-ABL1 (e.g., for minimal residual disease monitoring) | Alternative or complementary molecular quantification methods; may be used when a non-proprietary assay is performed |
86334 | Antibody; infectious agent antigen detection — Data not applicable | Data not provided; not in list |
83912 | Assay of nucleic acids by probe; hybridization, each separate probe | Related molecular techniques sometimes billed in lab workflows (method-dependent) |