Summary & Overview
CPT 80145: Adalimumab Level Assay for Therapeutic Drug Monitoring
CPT code 80145 represents a laboratory assay that quantifies adalimumab levels in patient specimens. Therapeutic drug monitoring for adalimumab guides clinical management of immune‑mediated diseases treated with this anti–TNF‑alpha biologic and has growing relevance as biologic therapies expand. The code denotes a technical laboratory measurement performed by a lab analyst using immunoassay or similar analytic platforms.
Key payers in the national analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find an overview of how CPT code 80145 is used in clinical care, a summary of payer coverage considerations, and contextual information about clinical applications for adalimumab monitoring. The publication also covers what to expect in billing and service settings, typical sites of service, and common laboratory workflows where this assay is performed.
The report provides benchmarks where available, notes on policy updates affecting lab reimbursement, and clinical context on when adalimumab level testing is ordered. Data not available in the input will be indicated explicitly in relevant sections.
Billing Code Overview
CPT code 80145 describes a laboratory analytic procedure in which the lab analyst measures the concentration of adalimumab, a therapeutic monoclonal antibody that targets tumor necrosis factor–alpha (TNF–a). This test quantifies drug levels in a patient specimen to inform therapeutic monitoring for immune‑mediated conditions treated with adalimumab.
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Service type: Clinical pharmacology/toxicology laboratory assay (therapeutic drug monitoring)
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Typical site of service: Clinical laboratory or hospital laboratory performing specialty immunoassay testing
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Clinical & Coding Specifications
Clinical Context
A typical patient is a 35–60 year old individual with a chronic immune‑mediated inflammatory condition such as rheumatoid arthritis, Crohn disease, ulcerative colitis, psoriatic arthritis, or ankylosing spondylitis who is receiving maintenance therapy with the monoclonal antibody adalimumab. The clinical workflow begins when a treating specialist (rheumatologist, gastroenterologist, or dermatology specialist) orders a therapeutic drug monitoring test to measure serum adalimumab concentration to assess drug exposure, investigate loss of response, or guide dose adjustment. A venous blood specimen is collected in an outpatient phlebotomy setting during a routine clinic visit or infusion/biologic clinic, labeled, and sent to the laboratory. In the clinical laboratory, a medical technologist or lab analyst performs the quantitative immunoassay (the technical component) and generates a numerical adalimumab level. The laboratory report is delivered to the ordering provider, who integrates the result with clinical status and other tests (for example anti‑drug antibody testing) to determine therapeutic decisions. Typical sites of service include outpatient clinics, ambulatory infusion or biologic centers, and clinical pathology laboratories. The patient scenario frequently involves evaluation for secondary nonresponse, subtherapeutic levels prior to dose escalation, or confirmation of adequate trough concentration when symptoms persist despite therapy.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component |