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    v1.0.30
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0438u-effectiverx-pharmacogenomic-panel-33-genes
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    CPT 0438U: EffectiveRX™ Comprehensive Pharmacogenomic Panel

    CPT code 0438U is a Proprietary Laboratory Analyses (PLA) code for the EffectiveRX™ Comprehensive Panel from RCA Laboratory Services LLC d/b/a GENETWORx, a pharmacogenomic test that analyzes variants in 33 genes and performs CYP2D6 duplication/deletion evaluation from a buccal swab to generate a personalized medication response profile and gene–drug interaction report; service type: genetic/pharmacogenomic diagnostic testing performed by a reference or specialty laboratory, typical site of service: outpatient laboratory or clinician office collecting a buccal specimen.

    For related coverage guidance, see recent payer policy updates: Biomarker Testing Mandate, Prenatal (Fetal) Diagnostic Testing, Oral Cancer Screening and Testing.

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    Clinical & Coding Specifications

    Clinical Context

    A 45-year-old patient with a history of multiple medication trials for major depressive disorder and persistent treatment-emergent adverse effects is referred by a primary care physician to a psychiatric clinic for pharmacogenomic testing. The clinician orders the EffectiveRX™ Comprehensive Panel (0438U) from GENETWORx to assess single nucleotide variants across 33 pharmacogenes and CYP2D6 copy-number variation using a buccal swab. The patient provides informed consent, completes a buccal swab collection at the clinic, and the specimen is forwarded to the laboratory. The lab performs variant analysis and duplication/deletion testing for CYP2D6, interprets results relative to established drug–gene interaction databases, and returns a report that includes patient drug–response phenotypes and a personalized medication guidance summary. The clinician reviews the report with the patient to inform medication selection and dosing adjustments, documents the test result in the electronic medical record, and communicates changes to the prescribing providers and pharmacy as needed.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    81225CYP2D6 gene analysis, common variants and copy number (example)May be ordered when targeted CYP2D6 testing is required or to confirm copy-number findings; overlaps with duplication/deletion evaluation reported in 0438U
    81226CYP2C19 gene analysisOften complementary when broader pharmacogenomic profiling is performed for antiplatelet or psychotropic drug metabolism
    81479Unlisted molecular pathology procedureUsed when a proprietary PLA test lacks an applicable CPT and reporting is required for unusual or additional analyses (less common for PLA-coded tests)
    99000Handling and/or conveyance of specimen for transfer from patient to laboratory (example)Administrative or courier charges sometimes billed separately when specimens are shipped to external labs
    G0452Specimen handling for molecular pathology (example)Used in certain payer contexts for specimen handling; may accompany laboratory billing workflows

    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
    2084P0800X
    208000000X
    2084F0202X
    173C00000X
    246YC3301X
    2470A2800X
    332BP3500X

    Related ICD-10-CM Codes

    25 rows

    ICD-10-CM CodeDescription
    B20Human immunodeficiency virus [HIV] disease
    C50.919Malignant neoplasm of unspecified site of unspecified female breast
    E03.9Hypothyroidism, unspecified
    E11.9Type 2 diabetes mellitus without complications
    E78.5Hyperlipidemia, unspecified
    F10.20Alcohol dependence, uncomplicated
    F11.20Opioid dependence, uncomplicated
    F17.200Nicotine dependence, unspecified, uncomplicated
    F32.9Major depressive disorder, single episode, unspecified
    F33.1Major depressive disorder, recurrent, moderate

    Showing 1–10 of 25

    Related Payer Policy Updates

    Specialty: Genetic & Molecular Testing1 / 3

    10 rows

    PolicyPayerEffective Date
    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
    Pharmacogenetic Panel Testing (for Ohio Only)Colorado Rocky Mountain Health Plans2026-11-01
    Cell-Free Fetal DNA Testing (for Kansas Only)Colorado Rocky Mountain Health Plans2026-11-01
    Genetic Testing for Neurological Disorders (for Kentucky Only)Colorado Rocky Mountain Health Plans2026-11-01

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

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

    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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