Summary & Overview
CPT 0044U: Tick–Borne Relapsing Fever Borrelia ImmunoBlot IgG Test
CPT code 0044U identifies a Proprietary Laboratory Analyses (PLA) test: the Tick–Borne Relapsing Fever (TBRF) Borrelia ImmunoBlots IgG produced by IGeneX Inc. The code designates a single manufacturer-specific serologic assay that detects IgG antibodies to four Borrelia species implicated in tick-borne relapsing fever. Nationally, PLA codes like 0044U matter because they enable distinct reporting, tracking, and payment for proprietary diagnostics that do not map to general test families.
Key payers in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the test’s clinical purpose, typical service setting, and payer landscape. The publication outlines common billing modifiers and procedural context where available, summarizes implications for claims submission and coding accuracy, and places the assay in clinical context for diagnosing Borrelia-related infections. This content provides actionable reference material for coding professionals, laboratory billing teams, and policy analysts seeking clarity on how a PLA-designated serologic assay is reported and where it fits within national diagnostic coding and payer frameworks.
Data not available in the input: Associated taxonomies, ICD-10 diagnoses, related codes, and specific payer policy details.
Billing Code Overview
CPT code 0044U is a Proprietary Laboratory Analyses (PLA) code that describes a single, manufacturer- or laboratory-specific test: the Tick–Borne Relapsing Fever (TBRF) Borrelia ImmunoBlots IgG from IGeneX Inc. The test detects IgG antibodies to four species of Borrelia, the tick-borne bacteria associated with relapsing fever and related Borrelia infections.
Service Type: Laboratory serologic diagnostic test for tick-borne Borrelia infection
Typical Site of Service: Clinical laboratory or reference laboratory setting, with specimen collection commonly performed in outpatient clinics, physician offices, or phlebotomy centers.
Clinical & Coding Specifications
Clinical Context
A 38-year-old patient presents to an infectious disease clinic with a history of multiple tick exposures while hiking in a region endemic for relapsing fever. The patient reports recurrent febrile episodes, headache, myalgias, and a transient rash over the prior several weeks. Prior routine Lyme serology was negative or equivocal. The clinician orders the proprietary Tick–Borne Relapsing Fever (TBRF) Borrelia ImmunoBlots IgG (0044U) from IGeneX Inc. to detect IgG antibodies to four Borrelia species associated with tick-borne relapsing fever.
Workflow:
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The ordering clinician documents clinical suspicion for relapsing fever or nonspecific tick-borne illness in the outpatient chart and places the laboratory order for
0044U. -
A phlebotomist obtains a serum specimen at an ambulatory clinic or outpatient lab; typical site of service is an outpatient clinic, physician office, or independent laboratory collection center.
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The specimen is sent to the performing laboratory (IGeneX Inc.) with appropriate test requisition and clinical history; the lab performs the immunoblot and reports qualitative IgG results for the four Borrelia species.
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Results are reviewed by the ordering clinician; positive IgG may support a diagnosis of prior or ongoing tick-borne relapsing fever infection and guide additional clinical evaluation or therapy. Negative results may prompt consideration of acute testing, alternative diagnoses, or repeat testing based on timing of exposure and symptom onset.
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Billing for the test uses the PLA code
0044Uwith appropriate modifier(s) as clinically indicated and the laboratory’s CLIA and payer contractual details applied during claims submission.