Summary & Overview
CPT 80200: Tobramycin Quantitative Drug Assay
CPT code 80200 designates a laboratory procedure to quantitatively measure the concentration of the antibiotic tobramycin in a patient specimen. This therapeutic drug monitoring (TDM) assay has national importance for optimizing dosing, preventing toxicity, and supporting antimicrobial stewardship programs, particularly for patients with renal impairment or on prolonged aminoglycoside therapy.
Key payers addressed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication outlines payer coverage considerations, coding practice guidance, and typical sites of service for laboratory testing. Readers will find clinical context on why tobramycin quantitation matters, operational benchmarks for lab provision of TDM services, and policy-relevant information affecting billing and payment for quantitative drug assays. Where input data is missing, the document notes that specific items are not available in the input.
Billing Code Overview
CPT code 80200 describes a laboratory assay in which a lab analyst performs the technical testing to quantitate the amount of the antibiotic tobramycin in a biological specimen. The service is a quantitative therapeutic drug monitoring (TDM) laboratory test performed by clinical laboratory personnel.
Service type: Laboratory — quantitative drug assay (therapeutic drug monitoring).
Typical site of service: Clinical laboratory or hospital laboratory (specimens collected in outpatient clinics, hospitals, or ambulatory collection centers and analyzed in a certified laboratory).
Clinical & Coding Specifications
Clinical Context
A typical patient is a hospitalized adult receiving intravenous tobramycin for severe Gram-negative sepsis or ventilator-associated pneumonia who requires therapeutic drug monitoring. The clinical workflow begins when the treating physician orders a serum tobramycin concentration to guide dosing. A timed blood specimen (often trough and/or peak) is collected by nursing and sent to the hospital laboratory. The clinical laboratory technician performs the analytical assay to quantitate tobramycin (CPT 80200) and reports the concentration to the ordering clinician. Results inform dose adjustments, interval changes, or discontinuation to avoid toxicity (nephrotoxicity, ototoxicity) while maintaining efficacy. Typical sites of service include hospital inpatient laboratories, outpatient hospital clinics, and independent clinical reference laboratories. Common patient scenarios include critically ill patients on once-daily or multiple-daily aminoglycoside regimens, patients with renal impairment requiring level monitoring, and pediatric patients receiving weight-based dosing where peak/trough measurements guide therapy.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier applicable (default) | Use when no specific modifier applies to the claim. |
11 | Primary procedure | Use when this test is the primary service provided on the date of service. |
26 | Professional component | Use when billing only the professional component (interpretation) of a test, if applicable; many quantitative drug assays report technical only. |
TC | Technical component | Use when billing only the laboratory technical component for the assay performed by the lab. |
90 | Reference (outside) laboratory | Use when the specimen is sent to an outside reference laboratory and that lab bills separately. |
91 | Repeat clinical diagnostic laboratory test | Use when a repeat quantitative tobramycin level is performed on the same day for medical reasons. |
59 | Distinct procedural service | Use when this test is distinct and separate from another service on the same day that would normally bundle. |
52 | Reduced services | Use when the assay is performed but at a reduced scope or intensity. |
77 | (Not listed in provided modifiers — omitted) | (Omitted) |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 183P00000X | Clinical Pathology | Lab directors and pathologists overseeing toxicology and therapeutic drug monitoring. |
| 207L00000X | Clinical Laboratory | Clinical laboratory technologists/technicians performing the assay. |
| 207LP2900X | Clinical Chemistry | Specialists focused on quantitative serum drug assays. |
| 207Q00000X | Hospital Laboratory | Hospital-based laboratory personnel handling inpatient samples. |
| 208000000X | Internal Medicine | Ordering clinicians managing antimicrobial therapy and interpreting levels. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
A41.9 | Sepsis, unspecified organism | Tobramycin levels are monitored in septic patients receiving aminoglycoside therapy. |
J15.9 | Bacterial pneumonia, unspecified | Tobramycin may be used for severe Gram-negative pneumonia; serum levels guide dosing. |
N17.9 | Acute kidney failure, unspecified | Renal impairment affects tobramycin clearance; monitoring is essential to avoid toxicity. |
T36.8X5A | Adverse effect of aminoglycosides, initial encounter | Used when monitoring or managing suspected aminoglycoside toxicity. |
P36.9 | Bacterial sepsis of newborn, unspecified | Neonates receiving aminoglycosides require therapeutic drug monitoring due to variable pharmacokinetics. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
36415 | Collection of venous blood by venipuncture | Often performed immediately before CPT 80200 for trough or peak level sampling. |
80053 | Comprehensive metabolic panel | Frequently ordered with tobramycin levels to monitor renal function before or during therapy. |
81000 | Urinalysis, by dipstick | May be ordered to evaluate renal status when monitoring aminoglycoside therapy. |
99000 | Handling and/or conveyance of specimen (not an actual CPT; placeholder) | Data not available in the input. |
00000 | (Placeholder) | Data not available in the input. |