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 | Use when only the professional interpretation component of a split-service laboratory test is billed separately |
TC | Technical component | Use when only the technical component (laboratory processing) is billed |
52 | Reduced services | Use if the test was partially reduced or not fully performed |
53 | Discontinued procedure | Use if specimen collection or testing was started but discontinued for clinical reasons |
62 | Two surgeons or co-surgeons (rare for lab) | Rarely applicable; use only when dual-surgeon reporting is relevant to an associated procedure |
78 | Return to operating/procedure room for a related procedure by same physician | Use only if a related invasive procedure required re-entry (uncommon for lab testing) |
80 | Assistant surgeon | Use when an assistant surgeon is reportable for an associated surgical procedure |
82 | Assistant surgeon (when qualified resident not available) | Use when required for an associated procedure |
QK | Medical direction of 2–4 assistants | Use when applicable to an associated procedure requiring medical direction |
QX | Registered NPP (non-physician practitioner) service | Use when a qualified non-physician practitioner performs an associated service |
QY | Certified registered nurse anesthetist service | Use only if related anesthesia services are billed |
SH | Diagnostic or therapeutic service furnished under an outpatient psychiatric facility's partial hospitalization | Use only when applicable to the site of service |
TC | Technical component | (Listed above) Use when billing technical component only |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207RG0100X | Gastroenterology | Gastroenterologists commonly order infliximab level testing to manage IBD therapy |
| 207RH0000X | Internal Medicine | Internists or hospitalists managing biologic therapy may order therapeutic drug monitoring |
| 207QH0002X | Pediatric Gastroenterology | Pediatric gastroenterologists order drug levels for children on infliximab |
| 261QM0800X | Laboratory Medicine | Pathologists and clinical laboratory directors oversee testing and result validation |
| 363L00000X | Infusion Center | Infusion nurses and centers coordinate specimen collection prior to infusions |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
K50.00 | Crohn disease of small intestine without complications | Crohn disease patients on infliximab commonly require drug level monitoring |
K50.90 | Crohn disease, unspecified, without complications | General Crohn disease diagnosis associated with infliximab therapy |
K51.90 | Ulcerative colitis, unspecified, without complications | Ulcerative colitis patients treated with infliximab may require therapeutic monitoring |
M06.9 | Rheumatoid arthritis, unspecified | Some rheumatologic conditions treated with infliximab where serum drug levels are clinically relevant |
M45.9 | Ankylosing spondylitis, unspecified | Spondyloarthropathies treated with infliximab that may require TDM (therapeutic drug monitoring) |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
36415 | Collection of venous blood by venipuncture | Venous specimen collection required prior to performing the 0515U assay |
80053 | Comprehensive metabolic panel | Common concurrent laboratory testing ordered during infusion visits to assess baseline chemistry |
86644 | Infliximab (therapeutic) antibody, qualitative or semi-quantitative | Complementary testing when anti-drug antibodies are suspected alongside infliximab level measurement |
84702 | Therapeutic drug assay, other (e.g., biologic drug concentration) | General category code sometimes used for non-proprietary assays measuring biologic drugs |
99000 | Handling and/or conveyance of specimen for transfer from physician office to outside lab | Billing element used in some settings when specimens are transported to external performing laboratories |