Summary & Overview

CPT 0316U: Lyme Borrelia Nanotrap® Urine Antigen Test

CPT code 0316U designates a Proprietary Laboratory Analyses (PLA) test for the Lyme Borrelia Nanotrap® Urine Antigen Test by Galaxy Diagnostics Inc. The code identifies a specific laboratory-developed assay that enriches and captures outer surface protein A (OspA) from urine using Nanotrap® nanoparticles, followed by Western blot quantification to indicate active Borrelia infection. Proprietary PLA codes matter nationally because they enable unique identification, tracking, and reimbursement of single-manufacturer tests that may offer novel diagnostic capabilities for conditions such as Lyme disease.

Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the clinical purpose of the test, the typical laboratory service context, and the payer landscape relevant to this PLA code. The publication provides benchmarks and policy-relevant details about proprietary laboratory codes, explains clinical context for urine antigen detection of Borrelia OspA, and summarizes common modifiers and administrative considerations where available. Data not available in the input is noted where applicable. This resource is intended for billing managers, laboratory directors, and policy analysts seeking a focused, national-level briefing on CPT code 0316U and its role in diagnostic testing for Lyme disease.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0316UCPTProprietary Laboratory AnalysesLyme diseaseUrine antigen testNanotrapOspALaboratory diagnostics

Billing Code Overview

CPT code 0316U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Lyme Borrelia Nanotrap® Urine Antigen Test from Galaxy Diagnostics Inc. The assay uses proprietary nanoparticle technology (Nanotrap®) to capture outer surface protein A (OspA) from urine, enrich small quantities of the antigen, and quantify OspA using a Western blot laboratory procedure as an indicator of active infection with Borrelia species.

Service type: Laboratory testing (proprietary urine antigen detection with sample enrichment and Western blot quantification)
Typical site of service: Clinical laboratory or reference laboratory performing specialized diagnostic testing

Clinical & Coding Specifications

Clinical Context

A 38-year-old patient presents to an infectious disease clinic with a 3-week history of expanding erythematous rash after a hiking trip in a Lyme-endemic area, intermittent fevers, arthralgia, and new-onset fatigue. Prior serologic testing (ELISA and/or standard Western blot on serum) has been inconclusive or discordant with the clinical picture. The clinician orders the Lyme Borrelia Nanotrap® Urine Antigen Test (0316U) to detect OspA protein in urine as a marker of active Borrelia infection.

Clinical workflow: the outpatient clinician (primary care or infectious disease) documents history, physical exam, and rationale for advanced testing. A urine specimen is collected in the clinic or at an affiliated specimen collection site and sent to Galaxy Diagnostics for Nanotrap® enrichment and Western blot quantification. Results are returned to the ordering provider and incorporated into the diagnostic assessment and treatment planning. Typical sites of service include outpatient clinics, physician offices, and certified clinical laboratories performing the proprietary test. This service is billed using the Proprietary Laboratory Analyses code 0316U and may accompany other laboratory or office visit charges depending on encounter complexity.

Coding Specifications

Modifier	Description	When to Use
`26`

Taxonomy Code	Specialty	Notes
207Q00000X	Infectious Disease	Specialists who commonly order advanced Lyme diagnostics.
208000000X	Family Medicine	Primary care providers who evaluate tick exposures and early Lyme presentations.
207L00000X	Internal Medicine	Internists managing systemic presentations and ordering confirmatory testing.
261QM0800X	Pathology/Laboratory	Laboratory specialists overseeing test processing, interpretation, and reporting.
3336C0003X	Clinical Laboratory Personnel	Clinical laboratory scientists/technologists involved in specimen handling and testing.

ICD-10 Code	Description	Clinical Relevance
`A69.20`	Lyme disease, unspecified	General code for Lyme disease when specific manifestations are not otherwise classified; aligns with testing for active Borrelia infection.
`A69.21`	Meningitis due to Lyme disease	Neurologic manifestation prompting advanced testing for active infection.
`A69.23`	Arthritis due to Lyme disease	Joint involvement where antigen detection may support diagnosis of active disease.
`A69.29`	Other conditions associated with Lyme disease	Miscellaneous systemic or localized manifestations where confirmation of active infection is useful.
`R50.9`	Fever, unspecified	Nonspecific symptom that may trigger evaluation for infectious etiologies including Lyme disease.
`M79.7`	Fibromyalgia	Included because patients with chronic widespread pain are sometimes evaluated for persistent Lyme infection when symptoms overlap.
`R21`	Rash and other nonspecific skin eruption	Skin findings such as erythema migrans that lead to targeted Lyme testing.
`Z20.820`	Contact with and (suspected) exposure to Lyme disease	Epidemiologic reason for testing when recent tick exposure is reported.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0316U`	Lyme Borrelia Nanotrap® Urine Antigen Test (proprietary)	Primary code used to report this proprietary urine antigen assay for OspA detection.
`81000`	Urinalysis, by dipstick or tablet reagent for bilirubin, glucose, hemoglobin, ketones, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen; non-automated, with microscopy	May be performed at specimen collection to document urine quality or gross abnormalities prior to sending sample for specialized testing.
`36415`	Collection of venous blood by venipuncture	Billed when concurrent blood sampling (for serologic Lyme testing such as ELISA or Western blot on serum) is performed during the same encounter.
`87077`	Culture, bacterial, any source, other than blood, with isolation and presumptive identification of isolates, each organism	Occasionally used for differential diagnostic workup when co-infections or other urinary pathogens are suspected; complementary to specialized antigen testing.
`88342`	Immunohistochemistry, each antibody, per specimen; initial single antibody stain	Not routinely used for this urine antigen assay but may be relevant if tissue specimens are evaluated for spirochetal antigens in complex cases.
`87471`	Infectious agent detection by nucleic acid (DNA or RNA); Borrelia burgdorferi, amplified probe technique	Molecular testing for Borrelia DNA which may be ordered alongside or instead of antigen testing depending on clinical question.

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