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.