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    v1.0.31
    OpenPayerBilling CodesGenetic Analysis ProceduresCPT cpt-81261-igh-clonality-assay-lymphoid-neoplasm-detection
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    CPT 81261: IGH Clonality Assay for Lymphoid Neoplasms

    CPT code 81261 describes a laboratory molecular test that detects clonal immunoglobulin heavy chain (IGH@) gene rearrangements to identify clonal B‑cell populations indicative of lymphoid neoplasms; this is a molecular diagnostic clonality assay typically performed as a technical laboratory service in a clinical molecular pathology or reference laboratory setting (specialty: molecular diagnostics), used to support diagnosis and disease monitoring of B‑cell lymphoproliferative disorders.

    For related coverage guidance, see recent payer policy updates: Minimal Residual Disease (MRD) Testing for Cancer, Biomarker Testing Mandate, Prenatal (Fetal) Diagnostic Testing.

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    Clinical & Coding Specifications

    Clinical Context

    A 62-year-old patient presents to a hematology/oncology clinic with progressive lymphadenopathy, unexplained cytopenias, and constitutional symptoms. The treating hematologist orders lymphoid clonality testing to evaluate for a suspected B-cell lymphoproliferative disorder. A tissue specimen (excisional lymph node) or peripheral blood sample is collected and sent to a reference molecular pathology laboratory. The laboratory technologist performs DNA extraction and a PCR-based or next-generation sequencing assay targeting the Immunoglobulin heavy chain locus (IGH@) to detect clonal IGH gene rearrangements. The lab analyst documents specimen receipt, runs the technical assay, interprets assay quality metrics, and reports the presence or absence of a dominant clonal IGH rearrangement that supports a diagnosis of a lymphoid neoplasm. Typical sites of service include hospital outpatient laboratories, independent reference laboratories, and hospital-based molecular pathology labs. The service type is a molecular diagnostic laboratory test (technical component) performed as part of the diagnostic workup for suspected B-cell lymphomas, chronic lymphocytic leukemia, or minimal residual disease monitoring in treated lymphoid malignancies.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    81261IGH (immunoglobulin heavy chain) gene rearrangement analysis, clonality assessment (e.g., PCR, NGS) — technical component described in this recordPrimary molecular assay to detect clonal IGH rearrangements indicative of B-cell lymphoid neoplasia.
    81403Molecular pathology procedure level 3 (targeted gene sequencing)May be used for broader targeted sequencing panels performed alongside clonality testing to identify mutations relevant to diagnosis or prognosis.
    81275T-cell receptor beta (TCRB) gene rearrangement analysis, clonality assessmentPerformed when assessing T-cell clonality if a T-cell lymphoid neoplasm is suspected instead of B-cell disease.
    88184Flow cytometry, each additional marker; interpretation and reportFlow cytometry immunophenotyping of lymphoid populations is commonly performed before or alongside clonality testing to characterize cell populations.
    88342Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stainIHC stains (e.g., CD20, CD3) on lymph node tissue often precede molecular clonality testing and guide which assays to order.
    88112Cytopathology, evaluation and report of fine needle aspirateIf FNA is used for specimen collection, cytopathology evaluation occurs in the diagnostic workflow prior to molecular testing.

    Related Modifiers

    7 rows

    ModifierDescriptionWhen to Use
    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…
    90Modifier ‑90 (Reference/Outside Laboratory) indicates that a laboratory test was performed by an entity other than the treating or reporting provider. The American Medical Association defines…- Use CPT modifier -90 when a laboratory test is performed by an outside/reference laboratory (an entity other than the treating or reporting physician or qualified professional) and the claim needs…
    59Modifier 59 indicates a distinct procedural service when two procedures that are not normally billed together are clinically and procedurally separate. The CPT definition (as reiterated by CMS)…- Use modifier -59 to report a distinct procedural service when documentation supports that the procedure reported is not normally billed together with another service on the same day because of a…
    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…
    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…
    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…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    207RH0000X
    207K00000X
    207L00000X
    204C00000X
    2083P0011X
    2080P0206X
    3418M1130X
    207QS1201X

    Related ICD-10-CM Codes

    26 rows

    ICD-10-CM CodeDescription
    B20Human immunodeficiency virus [HIV] disease
    C82.90Follicular lymphoma, unspecified, unspecified site
    C83.30Diffuse large B-cell lymphoma, unspecified site
    C83.50Lymphoblastic (diffuse) lymphoma, unspecified site
    C84.90Mature T/NK-cell lymphomas, unspecified, unspecified site
    C85.80Other specified types of non-Hodgkin lymphoma, unspecified site
    C90.00Multiple myeloma not having achieved remission
    C90.02Multiple myeloma in relapse
    C91.00Acute lymphoblastic leukemia not having achieved remission
    C91.01Acute lymphoblastic leukemia, in remission

    Showing 1–10 of 26

    Related Payer Policy Updates

    Specialty: Genetic & Molecular Testing1 / 3

    10 rows

    PolicyPayerEffective Date
    Minimal Residual Disease (MRD) Testing for Cancerregence2027-01-01
    Biomarker Testing MandateBlue Cross Blue Shield - Rhode Island2027-01-01
    Prenatal (Fetal) Diagnostic TestingBlue Cross Blue Shield - Rhode Island2027-01-01
    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
    Polygenic Risk ScoreBlue Cross Blue Shield - Rhode Island2026-12-01
    Gene Expression Profiling for Cutaneous MelanomaBlue Cross Blue Shield - Rhode Island2026-12-01
    Genetic Testing for Macular Degenerationregence2026-11-01
    Pharmacogenetic Panel Testing (for Ohio Only)Colorado Rocky Mountain Health Plans2026-11-01

    Related Codes

    CPT-81105-HPA-1-PLATELET-ANTIGEN-1-GENOTYPING-ITGB3-CD61

    CPT 81105: HPA-1 (ITGB3/CD61) Genotyping, Technical Component

    CPT-81106-HPA-2-T145M-GENETIC-ALLELE-ANALYSIS

    CPT 81106: HPA-2 (T145M) Platelet Antigen Genotyping

    CPT-81107-HPA-3-GENETIC-ANALYSIS-TECHNICAL-COMPONENT

    CPT 81107: HPA‑3 (I843S) Platelet Antigen Genotyping

    CPT-81108-HPA-4-R143Q-GENOTYPING

    CPT 81108: HPA-4 (R143Q) Genotyping

    CPT-81109-HPA-5-K505E-GENETIC-ANALYSIS

    CPT 81109: HPA-5 (K505E) Genotyping Test

    CPT-81110-HPA-6-R489Q-GENOTYPING

    CPT 81110: HPA-6 (R489Q) Genotyping, Technical Component

    CPT-81111-HPA-9-V837M-ALLELE-ANALYSIS

    CPT 81111: HPA-9 (V837M) Genotyping, Technical Test

    CPT-81112-HPA-15-GENETIC-ANALYSIS-S682Y

    CPT 81112: HPA-15 (S682Y) Platelet Antigen Genotyping

    CPT-81120-IDH1-MOLECULAR-DIAGNOSTIC-TEST

    CPT 81120: IDH1 Mutation Detection, Technical Component

    CPT-81121-IDH2-MOLECULAR-DIAGNOSTIC-TEST

    CPT 81121: IDH2 Mutation Detection, Technical Component

    Showing 1–10 of 199

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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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