Summary & Overview
CPT 0615U: iDart™ Lyme IgM ImmunoBlot Kit
CPT code 0615U identifies a Proprietary Laboratory Analyses (PLA) test: the iDart™ Lyme IgM ImmunoBlot Kit from ID–FISH Technology Inc., an immunoassay that detects IgM antibodies to 26 recombinant Borrelia burgdorferi protein groups for evaluation of Lyme disease. PLA codes are single‑source codes tied to a specific manufacturer or laboratory, making 0615U important for accurate tracking, billing, and utilization monitoring of this proprietary Lyme assay nationwide.
Key payers in this analysis include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. The publication outlines payer coverage considerations, national benchmarking context, and clinical application of the assay in Lyme disease evaluation. Readers will find: an overview of the code’s clinical purpose and service settings; expected billing and coding context for laboratory services; comparison of payer coverage presence and potential reimbursement patterns; and implications for laboratory operations and reporting when using a PLA code.
This summary is intended for billing managers, laboratory directors, and policy analysts seeking concise national context on CPT code 0615U, its clinical role in Lyme disease serology, and the administrative considerations tied to a proprietary laboratory test.
Billing Code Overview
CPT code 0615U is a Proprietary Laboratory Analyses (PLA) code assigned to the iDart™ Lyme IgM ImmunoBlot Kit from ID–FISH Technology Inc. The test is a laboratory immunoassay designed to detect immunoglobulin M (IgM) antibodies directed against 26 recombinant Borrelia burgdorferi protein groups to support evaluation for Lyme disease.
Service Type: Clinical laboratory diagnostic test using an immunoassay platform.
Typical Site of Service: Clinical laboratory or reference laboratory performing proprietary Lyme disease serologic testing.
Data not available in the input.
Clinical & Coding Specifications
Clinical Context
A 34-year-old patient presents to an outpatient infectious disease clinic in late spring with a recent history of a tick bite and new onset of fever, headache, myalgias, and an expanding erythematous rash suspicious for erythema migrans. The clinician performs a history and physical exam, documents possible early Lyme disease, and orders serologic testing to aid diagnosis. The laboratory performs the proprietary iDart™ Lyme IgM ImmunoBlot Kit (report with CPT code 0615U) on the patient’s serum to detect IgM antibodies to 26 recombinant Borrelia burgdorferi protein groups. The test is processed in a certified clinical laboratory (CLIA-waived not applicable; typically CLIA high-complexity or moderate-complexity lab) and results are returned to the ordering clinician to support clinical evaluation for acute or early Lyme disease.
Typical clinical workflow:
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Clinician evaluates patient and documents indication for Lyme serology.
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Blood specimen (serum) is collected, labeled, and shipped to a laboratory that performs the iDart™ Lyme IgM ImmunoBlot Kit.
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Laboratory performs the proprietary immunoblot assay and reports qualitative/semistructured results to the ordering provider with interpretation notes about IgM reactivity.
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Ordering clinician integrates test results with clinical findings to guide patient management and decisions about antibiotic therapy or further testing.
Typical site of service: outpatient physician office, urgent care clinic, or independent clinical laboratory performing specialized serologic testing.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
26 | Professional component | Use when reporting only the professional component (interpretation) of the test if performed separately from the technical component. |
TC | Technical component | Use when reporting only the technical component (laboratory processing) of the test when billed separately. |
90 | Reference lab | Use when the service is performed by a subcontracted reference laboratory. |
59 | Distinct procedural service | Use when it is necessary to indicate a distinct laboratory procedure or separate service not normally reported together (use cautiously for certain panel vs single-test billing scenarios per payer rules). |
91 | Repeat clinical diagnostic laboratory test | Use when the same laboratory test is repeated on the same day to obtain multiple results (per payer policies). |
24 | Unrelated E/M service by same physician on same day | Use when an unrelated evaluation and management service is provided on the same day as ordering/testing and needs separate payment. |
24X | Placeholder for site-specific X modifiers | Use only if payer requires a site-specific X modifier for lab-related claims (substitute actual X modifier per payer rules). |
QW | CLIA waived test | Not typically applicable to 0615U (included for completeness); use only if the specific assay were CLIA-waived. |
26-LT | Professional component, left side | Use only when laterality modifiers are required by payer for professional component (rare for lab tests). |
TC-RT | Technical component, right side | Use only when laterality is required by payer for technical component (rare for lab tests). |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
207Q00000X | Infectious Disease | Specialists frequently order and interpret Lyme serology. |
207L00000X | Clinical Pathology / Laboratory Medicine | Laboratory directors and pathologists oversee test validation, performance, and interpretation. |
204R00000X | Family Medicine | Primary care and urgent care clinicians commonly order initial Lyme testing. |
208D00000X | Emergency Medicine | Emergency clinicians may order Lyme serology for acute presentations in the ED. |
261QP2300X | Public Health Laboratory | Public health labs may perform or confirm specialized testing and surveillance. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
A69.20 | Lyme disease, unspecified | General code used for Lyme disease diagnosis when the specific manifestation is not specified; commonly associated with ordering serologic testing. |
A69.21 | Meningitis due to Lyme disease | Used when neurologic involvement is suspected and serologic testing including IgM may support diagnosis in early infection. |
A69.22 | Carditis due to Lyme disease | Used with suspected Lyme carditis; serology contributes to diagnostic evaluation. |
A69.29 | Other conditions associated with Lyme disease | Used for other organ-specific manifestations where serology aids evaluation. |
R50.9 | Fever, unspecified | Symptom code when fever prompts evaluation including Lyme serology in endemic settings. |
R50.1 | Fever with chills | Used when systemic symptoms lead to infectious workup including Lyme testing. |
L90.5 | Erythema chronicum migrans | Descriptive code for the classic Lyme rash; strongly associated with ordering Lyme serology. |
Z20.820 | Contact with and (suspected) exposure to vector-borne viral diseases | Used when documenting exposure risk such as known tick bite prompting serologic testing. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0615U | iDart™ Lyme IgM ImmunoBlot Kit — Proprietary Laboratory Analyses (PLA) code for detection of IgM antibodies to 26 recombinant Borrelia burgdorferi protein groups | Primary code used to report this specific proprietary Lyme IgM immunoblot assay. |
86617 | Antibody; Borrelia burgdorferi | Commonly ordered as an initial enzyme immunoassay (EIA) or screening antibody test before confirmatory immunoblot testing in a two-tiered algorithm. |
86618 | Antibody; Borrelia burgdorferi, IgM | Alternative/general code for IgM antibody testing for Lyme disease when a non-proprietary method is used; may be used if payer requires mapping when PLA code is not recognized. |
86320 | Immunoassay for infectious agent antibody, qualitative or semi-quantitative; single-step method | May describe certain screening immunoassays performed prior to specific immunoblot confirmation. |
88120 | Cytopathology, fluid, except nongynecologic | Not typically related; included here only if specimen processing or specialized cytology is needed in rare atypical presentations. (If unrelated, Data not available in the input.) |
Note: If local payer or laboratory policies require, the screening EIA (86617) is often performed before or in parallel with confirmatory immunoblot assays such as the proprietary 0615U test to support Lyme disease diagnosis.