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    v1.0.30
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0016u-bcr-abl1-major-minor-fusion-transcript-testing
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    CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

    CPT code 0016U describes a Proprietary Laboratory Analyses (PLA) test for detection and quantitation of BCR–ABL1 major and minor breakpoint fusion transcripts performed by University of Iowa, Department of Pathology or Asuragen on whole blood or bone marrow aspiration specimens; service type is molecular diagnostic laboratory testing and the typical site of service is clinical laboratory or hospital pathology department.

    For related coverage guidance, see recent payer policy updates: Oral Cancer Screening and Testing, RTM Testing for Alpha-1 Antitrypsin Deficiency, Cytochrome P450 Genotype-Guided Treatment Strategy Corporate Medical Policy.

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    Clinical & Coding Specifications

    Clinical Context

    A 58-year-old patient with newly diagnosed chronic myeloid leukemia (CML) presents for initial molecular baseline testing and later for routine disease monitoring. Peripheral whole blood or bone marrow aspiration is collected and sent to a reference laboratory (University of Iowa Department of Pathology or Asuragen) for BCR–ABL1 major (p210) and minor (p190) breakpoint fusion transcript quantification using a validated laboratory-developed test described by PLA code 0016U. The clinical workflow includes: ordering the test in the electronic medical record, obtaining informed consent for laboratory testing as required by the facility, phlebotomy or bone marrow aspiration by oncology or hematology staff, specimen packaging and shipment to the performing lab, and receipt of a quantitative molecular report used by the treating hematologist/oncologist to guide diagnosis, initial therapy selection, and ongoing response assessment (to assess molecular response, minimal residual disease, or possible relapse). Typical sites of service are hospital inpatient, hospital outpatient infusion or oncology clinic, and reference laboratory processing. Common clinical indications include initial confirmation of BCR–ABL1 transcript presence at diagnosis, baseline quantification before tyrosine kinase inhibitor therapy, periodic monitoring for major molecular response, and evaluation of rising transcript levels suggesting loss of response or resistance.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    81025Urinalysis, by dip stick or tablet reagent; multiple constituents, non-automated, with microscopyOften performed as part of baseline evaluation but not directly related to molecular testing
    36415Collection of venous blood by venipunctureCommonly performed to obtain peripheral whole blood specimen sent for 0016U
    38221Bone marrow; aspiration onlyPerformed when bone marrow aspiration is required for specimen collection for BCR–ABL1 testing
    86336BCR-ABL p210 (This is an example molecular immunoassay code)Other molecular tests for BCR-ABL may be ordered alongside or instead of the PLA; used in parallel workflows
    88363Flow cytometry test(s) performed using peripheral blood or bone marrow aspirate; interpretation and reportPerformed in hematologic malignancy workups and may accompany molecular testing for comprehensive assessment

    Related Modifiers

    7 rows

    ModifierDescriptionWhen to Use
    22Modifier –22 (Increased Procedural Services) is used when a reported procedure is substantially more extensive than normally required. The CPT Manual and CMS state it may be appended only when the…- When to use: Append modifier -22 to a procedural CPT code when the service performed is substantially more extensive than the usual service described by that code — i.e., the procedure required…
    26Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
    52Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
    53Modifier 53 (Discontinued Procedure) signals that a surgical or diagnostic service was begun by the physician but terminated because of extenuating circumstances that threatened the patient’s…- Use modifier -53 when a physician/qualified healthcare professional has started a surgical or diagnostic procedure (e.g., anesthesia administered, incision or scope insertion) and then discontinues…
    62Modifier 62 indicates that two surgeons function as co‑surgeons, each performing distinct parts of the same primary surgical procedure. It is appended to the primary procedure code (and any…- Use modifier -62 when two surgeons act as co‑surgeons (both primary surgeons) on a single definitive primary procedure, each performing distinct parts of the same surgical procedure (append -62 to…
    78CPT modifier -78 indicates an unplanned, related return to the operating or procedure room by the same provider during the global postoperative period. It is appended when treatment for a…- Use modifier -78 when an unplanned, related complication during the original procedure’s global postoperative period requires the patient to return to a formal operating or procedure room and the…
    80CPT® Modifier 80 (Assistant Surgeon) is appended to a surgical CPT code when a physician (MD or DO) provides full, continuous assistance throughout the operative procedure. It is intended only for…- Use CPT Modifier -80 when a physician (MD or DO) serves as an assistant surgeon and provides full, continuous assistance throughout the entire operative procedure; append -80 to the surgical CPT…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    207Q00000X
    207L00000X
    2084P0800X
    305R00000X
    102X00000X
    364SX0204X
    208000000X
    2085H0002X

    Related ICD-10-CM Codes

    27 rows

    ICD-10-CM CodeDescription
    C90.00Multiple myeloma not having achieved remission
    C92.00Acute myeloblastic leukemia, not having achieved remission
    C92.10Chronic myeloid leukemia, BCR/ABL-positive, not having achieved remission
    C92.20Atypical chronic myeloid leukemia, BCR/ABL-negative, not having achieved remission
    C92.40Acute promyelocytic leukemia, not having achieved remission
    C92.50Acute myelomonocytic leukemia, not having achieved remission
    C92.60Acute myeloid leukemia with 11q23-abnormality not having achieved remission
    D46.9Myelodysplastic syndrome, unspecified
    D47.1Chronic myeloproliferative disease
    D61.2Aplastic anemia due to other external agents

    Showing 1–10 of 27

    Related Payer Policy Updates

    Specialty: Genetic & Molecular Testing1 / 3

    10 rows

    PolicyPayerEffective Date
    Oral Cancer Screening and TestingOscar Health2027-01-01
    RTM Testing for Alpha-1 Antitrypsin DeficiencyOscar Health2027-01-01
    Cytochrome P450 Genotype-Guided Treatment Strategy Corporate Medical Policybcbsvermont2027-01-01
    Carrier Testing Panels for Genetic Diseases (for Kentucky Only)UnitedHealthcare2026-10-01
    Genetic Testing for Neurological Disorders (for Kansas Only)UnitedHealthcare2026-10-01
    Genetic and Molecular TestingProvidence Health Plan2026-10-01
    Cell-Free Fetal DNA Testing (for Idaho Only)UnitedHealthcare2026-10-01
    Next Generation Sequencing for Minimal Residual Disease DetectionProvidence Health Plan2026-10-01
    Pharmacogenetic Panel Testing (for Kansas Only)UnitedHealthcare2026-10-01
    Non-Covered Genetic Panel TestsProvidence Health Plan2026-10-01

    Related Codes

    CPT-0001U-PRECISETYPE-HEA-MULTIPLEX-RBC-ANTIGEN-GENOTYPING

    CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

    CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

    CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

    CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

    CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

    CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

    CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

    CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

    CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

    CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

    CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

    CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

    CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

    CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

    CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

    CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

    CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

    CPT-0017U-JAK2-MUTATION-UNIVERSITY-OF-IOWA

    CPT 0017U: JAK2 Mutation Sequencing, University of Iowa

    Showing 1–10 of 536

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    Frequently Asked Questions

    References

    1. 1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
    2. 2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
    3. 3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.
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