Summary & Overview
CPT 80197: Tacrolimus Quantitation, Technical Laboratory Assay
CPT code 80197 represents a laboratory technical service to quantify total tacrolimus levels in patient specimens. Tacrolimus is a critical immunosuppressant used after organ transplantation; accurate measurement guides dosing to prevent rejection and avoid toxicity, making this assay clinically important across transplant programs and specialty labs. Nationally, utilization of tacrolimus testing reflects the volume of transplant care and chronic immunosuppression management.
Key payers included in this analysis are Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication provides readers with benchmarks and contextual clinical information for CPT code 80197, policy and coding clarifications relevant to laboratory billing, and operational considerations for sites that perform specialized pharmacology assays.
Readers will learn the clinical purpose of the code, the typical service setting, payer coverage landscape, common modifiers and billing considerations where available, and how CPT code 80197 fits into laboratory service lines for transplant and immunosuppressant monitoring. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 80197 describes a technical laboratory assay to quantitate total tacrolimus in a patient specimen. This service involves analytic processing and measurement of tacrolimus, an immunosuppressant drug commonly used to prevent organ transplant rejection.
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Service type: Clinical laboratory drug quantitation (technical component)
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Typical site of service: Hospital or independent clinical laboratory performing specialty pharmacology testing
Data not available in the input for associated taxonomies, ICD-10 diagnoses, and related codes.
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.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier required | Default when no specific modifier applies. |
26 | Professional component | When reporting only the professional component for lab interpretation if applicable. |
90 |