Summary & Overview
CPT 0515U: Procise IFX™ Infliximab Quantitative Immunoassay
CPT code 0515U designates a Proprietary Laboratory Analyses (PLA) test for Procise IFX™ (ProciseDx Inc.), an immunoassay that quantitatively measures infliximab (IFX) levels in venous serum and reports results in µg/mL. This single-source PLA code matters nationally as therapeutic drug monitoring for biologic agents like infliximab increasingly informs dosing adjustments, treatment decisions, and value-based care models.
Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The coverage landscape for proprietary assays varies by payer policy, medical necessity criteria, and lab-provider contracting; stakeholders should reference each payer’s laboratory and specialty drug monitoring policies for specifics.
Readers will learn the clinical context for 0515U—therapeutic drug monitoring of infliximab—along with typical sites of service and how a PLA code differs from generic laboratory CPT codes. The publication provides benchmarks and payer coverage considerations, highlights policy and coding implications for single-manufacturer laboratory tests, and summarizes operational points relevant to laboratory billing and documentation. Data not available in the input will be noted where applicable.
Billing Code Overview
CPT code 0515U is a Proprietary Laboratory Analyses (PLA) code that applies only to a single, manufacturer- or lab-specific test. Report 0515U only for Procise IFX™ from ProciseDx Inc. The test uses an immunoassay to quantitatively measure infliximab (IFX) levels in venous serum and reports results in micrograms per milliliter (µg/mL).
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Service type: Quantitative therapeutic drug monitoring assay for infliximab levels
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Typical site of service: Clinical laboratory or outpatient phlebotomy/serology service
Clinical & Coding Specifications
Clinical Context
A 38-year-old patient with moderate-to-severe Crohn disease receiving maintenance infliximab therapy presents for routine therapeutic drug monitoring due to loss of response and intermittent abdominal pain. The gastroenterology clinic orders Procise IFX™ (0515U) to quantitatively measure serum infliximab levels prior to the next scheduled infusion. Blood is drawn from a venous specimen collection in the outpatient lab or infusion center; the specimen is sent to the performing laboratory or the manufacturer-designated testing site. The laboratory performs an immunoassay and reports the infliximab concentration in micrograms per milliliter (µg/mL). Results inform interpretation of drug exposure, potential anti-drug antibody assessment (if clinically ordered separately), and next steps in the therapeutic plan such as dose adjustment, interval change, or consideration of alternate biologic therapy.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default - no modifier | Applied when no other modifier is appropriate |
26 | Professional component |