Summary & Overview
CPT 0514U: Procise ADL™ Quantitative Adalimumab Immunoassay
CPT code 0514U designates the Procise ADL™ proprietary laboratory test from ProciseDx Inc., a quantitative immunoassay for measuring serum adalimumab (ADL) concentrations in patients receiving adalimumab therapy. As a PLA code, 0514U applies only to this single manufacturer-specific assay, which matters nationally for standardized reporting, lab billing specificity, and payer coverage determinations related to therapeutic drug monitoring of biologic therapies.
Key payers addressed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of clinical use—therapeutic drug monitoring to guide adalimumab dosing or evaluate treatment failure—and the typical laboratory site-of-service for the assay. The publication also provides benchmarks on billing and reimbursement where available, notes on payer policy considerations for PLA-designated tests, and the clinical context that informs test utilization.
This summary equips laboratory administrators, coding staff, and policy analysts with the essential facts about CPT code 0514U, what it represents in clinical practice, and which major payers are relevant for coverage and billing review. Data not available in the input for associated taxonomies, ICD-10 diagnoses, and related codes.
Billing Code Overview
CPT code 0514U is a Proprietary Laboratory Analyses (PLA) code assigned specifically to the Procise ADL™ assay by ProciseDx Inc. The test is an immunoassay that quantitatively measures adalimumab (ADL) levels in venous serum and reports results in micrograms per milliliter (µg/mL).
Service Type: Laboratory test — therapeutic drug monitoring (quantitative immunoassay)
Typical Site of Service: Clinical laboratory or reference laboratory using venous blood specimens
Data not available in the input for associated taxonomies, ICD-10 diagnoses, and related codes.
Clinical & Coding Specifications
Clinical Context
A 42-year-old patient with moderate-to-severe Crohn disease receiving adalimumab therapy presents for routine therapeutic drug monitoring after reporting a loss of response and increased gastrointestinal symptoms. The clinician orders the Procise ADL™ immunoassay (0514U) to obtain a quantitative adalimumab serum concentration in micrograms per milliliter to guide potential dose adjustment, interval change, or evaluation for anti-drug antibodies. Venous blood is drawn in an outpatient laboratory or clinic phlebotomy suite, specimen is processed to serum, and the proprietary assay is performed in a certified clinical laboratory using the manufacturer’s platform. Results are returned to the ordering gastroenterologist or rheumatologist and reviewed in the electronic medical record; result interpretation is integrated with clinical findings and, if available, antibody testing to inform therapeutic decisions. Typical sites of service include outpatient hospital laboratory, independent clinical laboratory, or outpatient clinic-based phlebotomy services. Typical patient scenarios include patients with inflammatory bowel disease, rheumatoid arthritis, psoriatic arthritis, or other chronic inflammatory conditions treated with adalimumab who require therapeutic drug monitoring.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Procedure/Service not further defined (placeholder) | Rarely used; typically not appended — included in raw list but not commonly applied to PLA reporting. |