CPT 0041U: Lyme ImmunoBlot IgM (IGeneX)

CPT code 0041U designates the proprietary Lyme ImmunoBlot IgM assay produced by IGeneX Inc., a laboratory serology test that detects IgM antibodies to five recombinant protein groups for identification of Borrelia burgdorferi, the causative agent of Lyme disease. As a PLA code, 0041U is unique to a single manufacturer and lab and is used where clinicians and payers need a specific identifier for this proprietary assay. Nationally, PLA codes like 0041U matter because they enable tracking, billing, and policy decisions for tests that do not have generic CPT equivalents.

Key payers covered in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise review of the clinical context for the assay, expected sites of service (clinical laboratories and independent diagnostic testing facilities), and which payers are addressed. The publication outlines benchmarks and payment considerations where available, clarifies coding and billing implications of using a PLA code, and situates the assay within laboratory diagnostic workflows for suspected Lyme disease. Data not available in the input is identified where applicable.

Billing Code Overview

CPT code 0041U is a Proprietary Laboratory Analyses (PLA) code describing the Lyme ImmunoBlot IgM test from IGeneX Inc. The test detects IgM antibodies to five recombinant protein groups to identify Borrelia burgdorferi, the tick-borne bacterium that causes Lyme disease.

Service type: Laboratory / Infectious disease serology

Typical site of service: Clinical laboratory or independent diagnostic testing facility (IDTF)

Clinical Context

A 34-year-old patient presents to an outpatient infectious disease clinic with a recent history of a tick bite and a 2-week history of fever, fatigue, headache, and an expanding erythematous skin lesion. The clinician documents concern for early Lyme disease and orders serologic testing to evaluate for acute infection. The specimen is collected by phlebotomy at the clinic and sent to IGeneX, Inc. for proprietary testing. The laboratory performs the Lyme ImmunoBlot IgM (0041U) to detect IgM antibodies against five recombinant Borrelia burgdorferi protein groups. Results are reported to the ordering provider electronically; interpretation includes band reactivity and an IgM positivity assessment. Typical workflow steps: order placed in the electronic health record, specimen drawn and accessioned, couriered to the reference lab, test performed by IGeneX, result finalized and routed back to the clinician, and follow-up plan documented in the outpatient visit note.

Coding Specifications

Modifier	Description	When to Use
`00`	HCPCS/CPT unmodified	Use when no modifier applies to the laboratory service
`11`	Office/Outpatient

Taxonomy Code	Specialty	Notes
`207RH0000X`	Infectious Disease	Specialists who commonly order confirmatory Lyme testing
`207RC0000X`	Internal Medicine	Primary care physicians who evaluate tick-borne illness
`208000000X`	Family Medicine	Clinicians in outpatient settings who collect specimens and order testing
`171M00000X`	Pathology & Laboratory Medicine	Laboratory directors or pathologists overseeing testing and reporting
`363LF0000X`	Phlebotomy/Specimen Collection	Personnel who perform specimen collection and handling

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`A69.20`	Lyme disease, unspecified	Directly indicates Lyme disease testing and is commonly used when serologic confirmation is sought
`A69.21`	Meningitis due to Lyme disease	Neurologic manifestations prompting serologic testing including IgM immunoblot
`A69.23`	Lyme arthritis	Joint symptoms that often trigger confirmatory Borrelia antibody testing
`R50.9`	Fever, unspecified	Nonspecific systemic symptom that may prompt evaluation for tick-borne infections including Lyme disease
`R53.83`	Other fatigue	Common symptom in early or disseminated Lyme disease leading to serologic evaluation
`L90.5`	Erythema chronicum migrans	Classic skin lesion of early Lyme disease that often prompts immediate serologic testing and clinical evaluation

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`36415`	Collection of venous blood by venipuncture	Commonly performed immediately before `0041U` to obtain the serum sample sent to IGeneX
`99000`	Handling and/or conveyance of specimen for transfer from the physician to a lab (when billable)	May apply when billing for specimen transportation or handling per payer policy
`80061`	Lipid panel (total, HDL, triglycerides)	Example of other laboratory tests that may be ordered at the same visit; not specific to Lyme testing
`86318`	Immunoassay for infectious agent antibody, qualitative or semiquantitative, multiple-step method; each additional step	Represents immunoassay methods commonly used in serologic testing workflows alongside specialized immunoblots
`87070`	Culture, bacterial; any source, aerobic, routine, with isolation and presumptive identification of isolates	May be ordered in differential diagnostic evaluation if other infections are considered

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Summary & Overview