Capital Bluecross Lyme Disease Testing Coverage

Coverage Criteria for Lyme Disease Testing

Covered clinical indications

Serologic testing using a two-tier strategy (EIA/IFA followed by immunoblot or FDA-cleared second EIA) MEETS COVERAGE CRITERIA when ANY of the following clinical contexts are present in an individual with travel/residence in an endemic region:

Covered clinical presentations: a) Symptoms of Lyme disease with history of travel to or residence in an endemic region (with or without known tick bite). b) Acute myocarditis or pericarditis of unknown cause. c) Meningitis, encephalitis, or myelitis. d) Painful radiculoneuritis. e) Mononeuropathy or mononeuropathy multiplex. f) Acute cranial neuropathy.

From policy indications list.

Not medically necessary / Exclusions

Serologic testing and other methods DO NOT MEET COVERAGE CRITERIA in the following situations:

Not covered indications: a) Screening asymptomatic patients living in endemic areas. b) Individuals with amyotrophic lateral sclerosis. c) Individuals with relapsing-remitting multiple sclerosis. d) Individuals with Parkinson's disease. e) Individuals with dementia, cognitive decline, or new-onset seizures. f) Individuals with psychiatric illness. g) Repeat serologic testing in individuals previously positive for Lyme disease. h) Detection of Borrelia burgdorferi by nucleic acid identification techniques (direct or amplified probe). i) Testing the tick for diagnosis. j) All other testing for Borrelia burgdorferi not described in covered indications (including nonvalidated proprietary or alternative assays).

Explicit noncoverage list from policy.

Covered when guideline-based criteria met

Coverage aligns with guideline-based testing strategies and clinical presentation.

CDC two-tier approach: Perform an initial EIA or IFA; if the first-step result is positive or equivocal, perform a second-tier immunoblot (western blot) or an FDA-cleared EIA as a modified two-tier test; if the initial EIA/IFA is negative, do not perform further testing on that specimen.

CDC and AAP guidance accepting FDA-cleared modified two-tiered assays.

Clinical diagnosis without testing: Patients presenting with erythema migrans (EM) should be diagnosed and treated clinically without laboratory testing.

NICE and AAP recommend clinical diagnosis for EM.

Neuroborreliosis evaluation: For suspected Lyme neuroborreliosis, obtain simultaneous CSF and serum specimens to calculate a CSF:serum antibody index; avoid relying on CSF serology alone and do not routinely use PCR or culture of CSF for diagnosis.

IDSA/AAN/ACR and AAP guidance recommending paired sampling and limited role for PCR.

Serologic testing and many alternative diagnostic methods for Lyme disease are limited by a lack of validation and therefore do not meet coverage criteria. Specifically, detection of Borrelia burgdorferi by nucleic acid identification techniques (direct or amplified probe) is listed as not meeting coverage criteria. Testing of the tick for diagnosis is also explicitly excluded. Proprietary or nonstandard antibody panels and other tests not described in the policy likewise do not meet coverage criteria due to insufficient published evidence or FDA clearance.

The policy identifies several specific modalities as lacking sufficient validation or specificity: urine antigen tests, CD57 assays, novel culture techniques, and antibody panels that differ from standardized two-tier testing have been reported as invalid or too nonspecific and are therefore inappropriate for diagnosis. Proprietary single-step assays and laboratory-specific tests are noted in the literature but are not accepted as replacements for the recommended two-tier or FDA-cleared modified two-tier approaches.

Routine testing of asymptomatic individuals following a tick bite or screening of asymptomatic patients living in endemic areas does not meet coverage criteria. The policy explicitly lists screening asymptomatic patients as a noncovered indication and cites guideline recommendations that advise against testing for exposure after an Ixodes tick bite when the patient is asymptomatic.

Providers should reserve serologic testing for patients with compatible clinical presentations and epidemiologic exposure. Guideline groups (IDSA/AAN/ACR and AAP) recommend clinical diagnosis for patients with erythema migrans and advise against routine laboratory testing in asymptomatic persons or for non-specific neurologic, psychiatric, or developmental complaints without supporting clinical evidence.

Repeat serologic testing in individuals who have previously tested positive for Lyme disease does not meet coverage criteria. The policy notes that once antibodies develop they may persist for many years and that repeating antibody tests is not useful for assessing cure or ongoing infection.

Broad use of non‑validated proprietary or alternative tests (for example, some urine tests and proprietary immunoblots offered by specialty laboratories) is not covered because these tests lack independent validation and FDA clearance. The policy references evaluations showing variable sensitivity and specificity among proprietary assays and reiterates that testing not described in the policy is considered not medically necessary.

Several tests have been specifically identified as invalid or insufficiently specific and therefore are not appropriate for diagnosing Lyme disease. Examples called out include urine B. burgdorferi tests, the CD57 assay, novel culture techniques, and antibody panels that diverge from standardized two‑tier testing.

The policy underscores that these modalities are commercially available in some laboratories but are not FDA cleared and have been found in independent assessments to produce nonspecific or false‑positive results. Consequently, they do not meet coverage criteria and should not be used for clinical decision making in place of validated two‑tier or FDA‑cleared modified two‑tier serologic testing.

Coding and Procedure Codes

Covered CPT Codesmixed

No codes listed

Procedure codes listedmixed

86617	Antibody; Borrelia burgdorferi (Lyme disease) confirmatory test (eg, Western Blot or immunoblot)
86618	Antibody; Borrelia burgdorferi (Lyme disease)
87475	Infectious agent detection by nucleic acid (DNA or RNA); Borrelia burgdorferi, direct probe technique
87476	Infectious agent detection by nucleic acid (DNA or RNA); Borrelia burgdorferi, amplified probe technique
0041U	Borrelia burgdorferi, antibody detection of 5 recombinant protein groups, by immunoblot; IgM (Proprietary: Lyme ImmunoBlot IgM, IGeneX Inc.)
0042U	Borrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot; IgG (Proprietary: Lyme ImmunoBlots IgG, IGeneX Inc.)
0316U	Proprietary test: Lyme Borrelia Nanotrap® Urine Antigen Test (Galaxy Diagnostics Inc.)

Inventory placeholder(no specific codes listed in this group)

Provider Actions, Prior Authorization, and Documentation

Note

Testing sequence requirement

Serologic testing for Lyme disease must follow a two-step/testing sequence: perform a first-tier EIA or IFA and only perform second‑tier testing (immunoblot/western blot or an FDA‑cleared second EIA as a modified two‑tier test) when the first‑tier result is positive or equivocal. If the first‑tier EIA/IFA is negative, no reflex/confirmatory immunoblot or second‑tier test should be performed.

Two‑tier sequence required: first‑tier EIA/IFA → second‑tier immunoblot or FDA‑cleared second EIA (MTTT) only if first tier is positive/equivocal.
Do not order a confirmatory immunoblot when the initial EIA/IFA is negative — specimen is considered seronegative per CDC/AAP guidance.

Denial Risk

Denial triggers — non‑covered indications

Serologic testing does NOT meet coverage criteria for multiple non‑covered indications; ordering tests for these situations may lead to claim denial.

Screening asymptomatic patients living in endemic areas (not covered).

Background on Lyme Disease and Testing

Lyme disease is a multisystem infection caused predominantly in North America by Borrelia burgdorferi transmitted by Ixodes ticks. Early infection commonly presents with erythema migrans (EM) and nonspecific systemic symptoms; if untreated, dissemination can involve the joints, heart, and nervous system.

Serologic testing detects host antibody responses and is less sensitive in early localized disease (when EM is present) but performs better in later stages. For this reason, guidelines and this policy emphasize clinical diagnosis and treatment for patients with EM and recommend serologic testing primarily for patients with compatible clinical syndromes and epidemiologic exposure.

Because antibody responses may persist for many years after infection, serology is not appropriate for routine screening of asymptomatic individuals, nor is repeat serologic testing after a documented prior positive result useful to assess treatment success or ongoing infection.

Definitions and Test Abbreviations

EIA

TermEIA (enzyme immunoassay)

DefinitionScreening serologic assay used as the first step in two-tier testing for Lyme disease.

Usage noteFirst-tier positive or equivocal results require second-tier testing per CDC/AAP guidance.

MTTT

TermMTTT (Modified Two-Tiered Testing)

DefinitionAn algorithm that replaces the second-tier western blot with an FDA-cleared EIA as the confirmatory test.

EvidenceClinical evaluation has shown increased early sensitivity for B. burgdorferi in at least one study.