Summary & Overview
CPT 80195: Sirolimus Quantitation, Therapeutic Drug Monitoring
CPT code 80195 represents the laboratory technical procedure to quantitate total sirolimus, an immunosuppressant widely used to prevent transplant rejection. Accurate measurement of sirolimus levels is clinically important for dose optimization, toxicity avoidance, and transplant graft management. Nationally, this test is a routine component of post-transplant care and is performed in hospital and commercial clinical laboratories.
Key payers addressed in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of how CPT code 80195 is used in practice, the clinical context for therapeutic drug monitoring of sirolimus, and what to expect in terms of service setting and procedure type. The publication summarizes common billing practices, relevant modifiers and payers for consideration, and clarifies where additional data is not available.
This report is intended to inform clinical, billing, and administrative stakeholders about the purpose and application of CPT code 80195, supporting consistent coding and billing for sirolimus quantitation services across payer types.
Billing Code Overview
CPT code 80195 describes a laboratory technical test that quantifies the total amount of sirolimus in a patient specimen. Sirolimus is an immunosuppressant drug commonly used to prevent organ transplant rejection. The service represented by this code is a therapeutic drug monitoring laboratory assay performed by a lab analyst to measure drug concentration in blood or other clinical specimens.
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Service type: Clinical laboratory drug quantitation (therapeutic drug monitoring)
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Typical site of service: Clinical laboratory or hospital laboratory performing specimen analysis
Clinical & Coding Specifications
Clinical Context
A 52-year-old kidney transplant recipient attends a routine outpatient transplant clinic visit for post-transplant therapeutic drug monitoring. The patient is on sirolimus as part of an immunosuppressive regimen to prevent allograft rejection. The transplant clinic orders a quantitative sirolimus trough level to ensure therapeutic concentration and avoid toxicity or under-immunosuppression. A phlebotomy technician draws a whole blood specimen and sends it to the clinical laboratory. In the lab, a clinical laboratory scientist performs the technical assay using liquid chromatography–tandem mass spectrometry to quantitate total sirolimus. The result is reported to the transplant team and entered into the electronic health record; the ordering provider reviews levels and documents management decisions in follow-up. Typical site of service: outpatient hospital laboratory or independent clinical reference laboratory; typical service type: therapeutic drug monitoring/clinical pharmacology assay.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when billing for the physician or pathologist interpretation component separate from the laboratory technical component (rare for quantitative drug assays). |
TC |