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    v1.0.28
    OpenPayerBilling CodesTherapeutic Drug AssaysCPT cpt-80197-tacrolimus-quantitation-lab-assay
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    CPT 80197: Tacrolimus Quantitation, Therapeutic Drug Monitoring

    CPT code 80197 describes a laboratory technical service that measures the total concentration of tacrolimus, an immunosuppressant drug commonly monitored after organ transplantation; the service is a quantitative drug assay performed by a lab analyst using a patient specimen, and the typical site of service is a clinical laboratory or hospital laboratory performing therapeutic drug monitoring.

    For related coverage guidance, see recent payer policy updates: B-Hemolytic Streptococcus Testing, Human Immunodeficiency Virus (HIV) — Coverage Criteria for Testing and Resistance Assays, Hepatitis Testing (A, B, C, D) Coverage Criteria.

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    Table of contents

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    Clinical & Coding Specifications

    Clinical Context

    A typical patient is a renal or liver transplant recipient on chronic immunosuppression with tacrolimus therapy. The patient presents for routine therapeutic drug monitoring during a clinic visit or outpatient laboratory visit. A blood specimen (usually whole blood collected in appropriate tube) is sent to the clinical laboratory. The laboratory analyst performs the quantitative tacrolimus assay to determine trough or steady-state concentration, which guides dose adjustments to prevent rejection or minimize toxicity. Results are reported to the transplant clinic, and may trigger same-day or follow-up medication adjustments, additional monitoring, or toxicity assessment if levels are supratherapeutic.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    36415Collection of venous blood by venipunctureSpecimen collection commonly performed prior to tacrolimus quantitation.
    80307Drug testing, qualitative; multiple drug classesAncillary toxicology testing sometimes ordered alongside tacrolimus monitoring in complex patients.
    80299Unlisted toxicology procedureOccasionally used if a unique testing method or non-standard panel is used for immunosuppressant measurement.

    Related Modifiers

    6 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…
    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…
    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…
    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…

    Related Provider Taxonomies

    8 rows

    Taxonomy CodeSpecialtyNotes
    207RC0000XCardiovascular Disease PhysicianAn internist who specializes in diseases of the heart and blood vessels and manages complex cardiac conditions such as heart attacks and life-threaten…
    207L00000XAnesthesiology PhysicianAn anesthesiologist is trained to provide pain relief and maintenance, or restoration, of a stable condition during and immediately following an opera…
    208000000XPediatrics PhysicianA pediatrician is concerned with the physical, emotional and social health of children from birth to young adulthood. Care encompasses a broad spectru…
    207K00000XAllergy & Immunology PhysicianAn allergist-immunologist is trained in evaluation, physical and laboratory diagnosis, and management of disorders involving the immune system. Select…
    2084P0800XPsychiatry PhysicianA Psychiatrist specializes in the prevention, diagnosis, and treatment of mental disorders, emotional disorders, psychotic disorders, mood disorders, …
    261QP2400XPrison Health Clinic/CenterAmbulatory Health Care Facilities · Clinic/Center
    152WL0500XLow Vision Rehabilitation OptometristOptometrists who specialize in low-vision care having training to assess visual function, prescribe low-vision devices, develop treatment plans, and r…
    156FX1800XOpticianOpticians help fit eyeglasses and contact lenses, following prescriptions from Ophthalmologists and Optometrists. They also help customers decide whi…

    Related ICD-10-CM Codes

    29 rows

    ICD-10-CM CodeDescription
    B20Human immunodeficiency virus [HIV] disease
    C61Malignant neoplasm of prostate
    D47.Z2Castleman disease
    D86.9Sarcoidosis, unspecified
    E10.65Type 1 diabetes mellitus with hyperglycemia
    E11.65Type 2 diabetes mellitus with hyperglycemia
    F17.210Nicotine dependence, cigarettes, uncomplicated
    H91.90Unspecified hearing loss, unspecified ear
    I12.9Hypertensive chronic kidney disease with stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease
    I50.9Heart failure, unspecified

    Showing 1–10 of 29

    Related Payer Policy Updates

    Specialty: Infectious Disease1 / 3

    10 rows

    PolicyPayerEffective Date
    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
    Testing for Diagnosis of Active or Latent TuberculosisOscar Health2026-10-01
    Testing for Vector-Borne InfectionsOscar Health2026-10-01
    Coronavirus Testing in the Outpatient SettingOscar Health2026-10-01
    Human Immunodeficiency Virus (HIV)blue cross blue shield - louisiana2026-09-15

    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-80159-CLOZAPINE-LEVEL-ASSAY-THERAPEUTIC-DRUG-MONITORING

    CPT 80159: Clozapine Level Measurement

    CPT-80161-CARBAMAZEPINE-EPOXIDE-QUANTITATIVE-ASSAY

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

    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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