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    v1.0.30
    OpenPayerBilling CodesTherapeutic Drug AssaysCPT cpt-80159-clozapine-level-assay-therapeutic-drug-monitoring
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    CPT 80159: Clozapine Level Measurement

    CPT code 80159 describes a laboratory test that measures the clozapine level in a patient’s specimen, a therapeutic drug monitoring service typically performed by a clinical laboratory using blood samples; service type: laboratory therapeutic drug monitoring; typical site of service: clinical laboratory or hospital laboratory performing blood-based testing.

    For related coverage guidance, see recent payer policy updates: Long-Acting Injectable Antiretroviral Agents for HIV, B-Hemolytic Streptococcus Testing, Human Immunodeficiency Virus (HIV) — Coverage Criteria for Testing and Resistance Assays.

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    Clinical & Coding Specifications

    Clinical Context

    A 38-year-old patient with treatment-resistant schizophrenia is receiving clozapine therapy under a monitored program. Periodic therapeutic drug monitoring is ordered to measure plasma clozapine concentration to assess adherence, efficacy, and risk of toxicity (including agranulocytosis and seizures). A clinician orders the clozapine level test when the patient reports increased sedation, confusion, or new seizures, after dose changes, or to confirm subtherapeutic levels when symptoms recur. A blood specimen is collected in an outpatient laboratory or hospital phlebotomy service, transported to the chemistry/toxicology laboratory, and analyzed using validated immunoassay or chromatography methods. Results are reported to the prescribing psychiatrist and documented in the medical record for dose adjustment and safety monitoring.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    80159Clozapine; quantitativePrimary test measuring plasma clozapine concentration for therapeutic monitoring.
    80480Clozapine metabolite testing; quantitative (example: norclozapine)Often performed alongside clozapine testing to assess metabolism and adherence.
    36415Collection of venous blood by venipunctureSpecimen collection required prior to performing 80159.
    80307Drug screen, qualitative; multiple drugs, any methodMay be ordered with 80159 when evaluating adherence or concomitant substance use.
    99000Handling and/or conveyance of specimen to outside lab (historical/unlisted)Administrative steps related to sending specimen to a reference laboratory (use depends on payer policy).

    Related Modifiers

    5 rows

    ModifierDescriptionWhen to Use
    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…
    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…
    91Modifier 91 — “Repeat Clinical Diagnostic Laboratory Test” — is appended when the exact same CPT laboratory test is performed more than once for the same patient on the same day because serial,…- Use modifier 91 when the exact same CPT laboratory test is performed more than once on the same patient on the same date because serial or repeated testing is medically necessary to monitor…
    74Modifier ‑74 indicates an outpatient hospital or ASC procedure that was discontinued after anesthesia was administered and after the procedure had begun. Use this modifier when anesthesia (local,…- Use modifier -74 when a procedure in an outpatient hospital or ASC setting is terminated after anesthesia has been administered and after the procedure has commenced (for example, after incision,…
    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…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    2084P0800X
    207L00000X
    207K00000X
    207LP4000X
    364SP0811X
    311Z00000X
    225XF0002X
    103TM1700X

    Related ICD-10-CM Codes

    27 rows

    ICD-10-CM CodeDescription
    D68.9Coagulation defect, unspecified
    E03.9Hypothyroidism, unspecified
    E11.9Type 2 diabetes mellitus without complications
    F06.8Other specified mental disorders due to known physiological condition
    F20.0Paranoid schizophrenia
    F20.3Undifferentiated schizophrenia
    F20.9Schizophrenia, unspecified
    F25.0Schizoaffective disorder, bipolar type
    F25.1Schizoaffective disorder, depressive type
    F29Unspecified psychosis not due to a substance or known physiological condition

    Showing 1–10 of 27

    Related Payer Policy Updates

    Specialty: Infectious Disease1 / 3

    10 rows

    PolicyPayerEffective Date
    Long-Acting Injectable Antiretroviral Agents for HIVColorado Rocky Mountain Health Plans2026-10-01
    B-Hemolytic Streptococcus TestingOscar Health2026-10-01
    Human Immunodeficiency Virus (HIV) — Coverage Criteria for Testing and Resistance AssaysOscar Health2026-10-01
    Hepatitis Testing (A, B, C, D) Coverage CriteriaOscar Health2026-10-01
    Lyme Disease Testing Coverage CriteriaOscar Health2026-10-01
    Pathogen Panel TestingOscar Health2026-10-01
    Diagnostic Testing of Common Sexually Transmitted InfectionsOscar Health2026-10-01
    Coronavirus Testing in the Outpatient SettingOscar Health2026-10-01
    Testing for Vector-Borne InfectionsOscar Health2026-10-01
    Testing for Diagnosis of Active or Latent TuberculosisOscar Health2026-10-01

    Related Codes

    CPT-80143-ACETAMINOPHEN-QUANTITATIVE-SERUM-ASSAY

    CPT 80143: Acetaminophen Quantitative Assay

    CPT-80145-ADALIMUMAB-LEVEL-ASSAY-THERAPEUTIC-DRUG-MONITORING

    CPT 80145: Adalimumab Quantitative Drug Level Assay

    CPT-80150-AMIKACIN-QUANTITATIVE-ASSAY-THERAPEUTIC-DRUG-MONITORING

    CPT 80150: Amikacin Quantitative Serum Level

    CPT-80151-AMIODARONE-QUANTITATIVE-SERUM-ASSAY

    CPT 80151: Amiodarone Quantitative Drug Level Assay

    CPT-80155-CAFFEINE-LEVEL-TESTING

    CPT 80155: Caffeine Level Quantification

    CPT-80156-CARBAMAZEPINE-TOTAL-LEVEL-LAB-ASSAY

    CPT 80156: Carbamazepine Total Level (Serum)

    CPT-80157-FREE-CARBAMAZEPINE-ASSAY

    CPT 80157: Free Carbamazepine Quantitative Assay

    CPT-80158-CYCLOSPORINE-QUANTITATIVE-ASSAY-LAB

    CPT 80158: Cyclosporine Quantitation, Laboratory

    CPT-80161-CARBAMAZEPINE-EPOXIDE-QUANTITATIVE-ASSAY

    CPT 80161: Carbamazepine 10,11-Epoxide Level, Quantitative

    CPT-80162-DIGOXIN-TOTAL-THERAPEUTIC-DRUG-MONITORING

    CPT 80162: Total Digoxin Level in Serum

    Showing 1–10 of 87

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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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