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    v1.0.30
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0009u-deparray-her2-fish-tumor-cell-isolation
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    CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

    CPT code 0009U describes DEPArray™ HER2 by PacificDx, a Proprietary Laboratory Analyses (PLA) test that performs tumor-cell isolation followed by fluorescence in situ hybridization (FISH) to determine whether the HER2/ERBB2 gene is amplified; service type: molecular pathology/tumor-cell isolation with FISH analysis; typical site of service: clinical laboratory or specialized molecular pathology laboratory.

    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 woman with a history of invasive breast carcinoma presents with a locally recurrent lesion after prior lumpectomy and adjuvant chemotherapy. The treating oncologist requires precise determination of HER2 (ERBB2) gene status from a small tissue sample and from tumor cells isolated from a heterogeneous specimen to guide targeted therapy decisions. A tissue or cytology specimen (core biopsy, fine-needle aspirate, or cell block) is submitted to a certified molecular laboratory. The laboratory performs the DEPArray™ tumor-cell isolation workflow to enrich for tumor cells, followed by fluorescence in situ hybridization (FISH) targeting HER2/ERBB2 to determine gene amplification status. The final report documents HER2 amplified, equivocal, or not amplified and is returned to the ordering oncologist for therapeutic planning. Typical site of service is an outpatient or hospital-based pathology/molecular laboratory; specimen collection occurs in an ambulatory clinic, imaging suite, or hospital procedure area.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    88377Special stains including interpretation and report; each additive stainMay be performed on the specimen for ancillary histochemical staining prior to or alongside FISH in pathology workflow.
    88384Immunohistochemistry (IHC), per specimen; each antigenIHC for HER2 protein expression is commonly performed before or concurrently with FISH to assess HER2 status.
    88367Morphometric analysis, tumor markersUsed when computerized image analysis complements FISH quantification in select cases.
    88271Flow cytometry, per specimen; single cell typeAlternative or complementary cell-based analyses; not specific to DEPArray™ but may be part of cellular characterization.
    88172Cytopathology, cell block, immunocytochemistryRelevant when cytology specimens or cell blocks are processed before molecular testing and enrichment.

    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…
    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…
    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…
    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…
    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
    207RG0100X
    363A00000X
    208D00000X
    2086P0122X
    2084A0401X
    163WD0400X
    1041C0700X
    261QA1903X

    Related ICD-10-CM Codes

    27 rows

    ICD-10-CM CodeDescription
    C50.011Malignant neoplasm of nipple and areola, right female breast
    C50.012Malignant neoplasm of nipple and areola, left female breast
    C50.111Malignant neoplasm of central portion of right female breast
    C50.112Malignant neoplasm of central portion of left female breast
    C50.121Malignant neoplasm of central portion of right male breast
    C50.211Malignant neoplasm of upper-inner quadrant of right female breast
    C50.212Malignant neoplasm of upper-inner quadrant of left female breast
    C50.311Malignant neoplasm of lower-inner quadrant of right female breast
    C50.312Malignant neoplasm of lower-inner quadrant of left female breast
    C50.411Malignant neoplasm of upper-outer quadrant of right female breast

    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-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-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

    CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

    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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