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    OpenPayerPolicy UpdatesLaboratory/PathologyHumana Lyme disease testing Coverage | OpenPayer
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    CurrentHumanaPolicy LAB2O23037

    Laboratory — Lyme Disease Testing Coverage Criteria

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    Humana payment policy for laboratory testing related to Lyme disease for Medicare Advantage and Commercial products, describing which serologic and molecular tests are reimbursable or not and referencing applicable Medicare LCD/NCD guidance.

    Policy Summary
    PayerHumana
    PolicyLaboratory — Lyme Disease Testing Coverage Criteria
    Policy CodePolicy LAB2O23037
    Change TypeNo material change
    Effective DateJun 1, 2023
    Last ReviewNov 1, 2024
    Next Review Date
    Key ActionUse a two-tier serologic testing strategy (screening EIA/IFA followed by confirmatory Western blot or FDA-cleared second EIA) and document clinical signs to support reimbursement.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2-tierSerologic approach
    Not reimb.PCR testing (87475)

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    7 codesIncluded codes
    Medicare Adv.Applies to

    Coverage Criteria for Lyme Disease Testing

    Reimbursable serologic testing

    Covered when clinical presentation is consistent with Lyme disease and testing follows the two-tier algorithm:

    Two-tier serology coverage: Initial sensitive EIA or IFA (86618) followed by a confirmatory Western immunoblot or FDA-cleared second EIA (86617)

    Examples of clinical presentations include fever, malaise, chills, fatigue, myalgia; cough or shortness of breath; acute myocarditis/pericarditis or cardiomyopathy; meningitis, encephalitis, or myelitis; painful radiculoneuritis; mononeuropathy multiplex or ataxia; acute cranial neuropathy; and urticaria.

    Not reimbursable molecular testing

    Not reimbursable for Medicare Advantage:

    PCR-based detection: PCR-based direct detection of Borrelia burgdorferi (87475) is not reimbursable; procedure code 87476 is also subject to payment criteria per referenced LCDs.

    The payment criterion for 87475 and 87476 applies to all Medicare jurisdictions except those states awarded to specific MACs (CGS Administrators, Noridian, Palmetto GBA, WPS) as listed in the policy and associated LCDs.

    The policy states that PCR-based direct detection of Borrelia burgdorferi (CPT 87475) is not reimbursable for Medicare Advantage. It further notes that payment criteria for molecular detection codes, including 87476, are governed by Medicare payment rules and applicable LCDs and may result in noncoverage in Medicare jurisdictions as described in the policy.

    Molecular PCR testing for Borrelia burgdorferi using CPT 87475 is explicitly listed as not reimbursable under this Medicare Advantage payment policy. Providers should therefore expect denial of reimbursement for 87475 when submitted for Medicare Advantage members except where specific MAC LCDs provide otherwise.

    When Testing is Covered

    Clinical signs or symptoms suggestive of Lyme disease

    Two-tier serology is the reimbursable testing strategy when indicated.

    Clinical indications: Clinical signs or symptoms suggestive of Lyme disease such as fever, malaise, chills, fatigue, myalgia; cough or shortness of breath; erythema migrans and other typical presentations including neurologic (meningitis, encephalitis, myelitis, radiculoneuritis, cranial neuropathy) or cardiac manifestations (myocarditis/pericarditis, cardiomyopathy); urticaria; mononeuropathy multiplex or ataxia.

    When these clinical findings are present, use an initial sensitive EIA/IFA (86618) followed by a confirmatory Western immunoblot or FDA-cleared second EIA (86617) for reimbursement.

    Applicable CPT / PLA Codes

    Applicable CPT/PLA codesmixed
    86617Antibody; Borrelia burgdorferi (Lyme disease) confirmatory test (eg, Western Blot or immunoblot).
    86618Sensitive enzyme immunoassay (EIA) or immunofluorescence assay for Borrelia burgdorferi (screening).
    87475Infectious agent detection by nucleic acid (DNA or RNA); Borrelia burgdorferi, direct probe technique.
    87476Infectious agent detection by nucleic acid (DNA or RNA); Borrelia burgdorferi, amplified probe technique.
    0041UBorrelia burgdorferi, antibody detection of 5 recombinant protein groups, by immunoblot, IgM (Proprietary test: Lyme ImmunoBlot IgM, IGeneX Inc).
    0042UBorrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot, IgG (Proprietary test: Lyme ImmunoBlot IgG, IGeneX Inc).
    0316UBorrelia burgdorferi (Lyme disease), OspA protein evaluation, urine (Proprietary test: Lyme Borrelia Nanotrap Urine Antigen Test, Galaxy Diagnostics Inc).

    Provider Actions and Documentation

    Prior Authorization

    Prior authorization / reimbursement note

    No prior authorization requirement is specified in this policy for the listed Lyme disease testing codes; however, reimbursement limitations described for Medicare Advantage and applicable LCDs still apply.

    Step Therapy

    Required two-tier testing sequence

    Follow a two-tier serologic testing sequence: perform an initial sensitive EIA or immunofluorescence assay (86618) as the screening test, followed by a confirmatory Western immunoblot or FDA-cleared second EIA (86617) for reimbursable testing.

    • Initial test: sensitive EIA or immunofluorescence assay (86618).
    • Confirmatory test: Western immunoblot or FDA-cleared second EIA (86617).

    Ordering Requirements

    Note

    Ordering requirements — provider scope

    This policy is intended for health care providers who treat Humana members; no specific ordering provider restrictions (such as specialty or setting) are listed in the policy.

    Not Covered

    Not covered: PCR-based direct detection of Borrelia burgdorferi (CPT 87475) is not reimbursable. The policy also indicates that 87476 is subject to Medicare payment criteria and referenced LCDs, which may lead to noncoverage depending on the Medicare Administrative Contractor jurisdiction.

    Background

    Lyme disease is caused by organisms in the Borrelia burgdorferi complex and can present with systemic, neurologic, or cardiac manifestations. The policy endorses serologic testing using a validated two-tier strategy (initial sensitive EIA/IFA, CPT 86618, followed by confirmatory Western immunoblot or FDA-cleared second EIA, CPT 86617) as the reimbursable laboratory approach. Molecular PCR testing for Borrelia burgdorferi (CPT 87475) is noted to have limited reimbursement and is not reimbursable for Medicare Advantage per this policy.

    Definitions

    Two-tier serologic testing — definition and codes
    DefinitionTwo-tier serologic testing: an initial sensitive enzyme immunoassay (EIA) or immunofluorescence assay followed by a confirmatory Western blot assay or an FDA-cleared second EIA (codes 86618 then 86617).
    Screening test code86618 — Sensitive enzyme immunoassay (EIA) or immunofluorescence assay for Borrelia burgdorferi (screening).
    Confirmatory test code86617 — Antibody; Borrelia burgdorferi confirmatory test (eg, Western Blot or immunoblot).
    Alternative FDA-cleared confirmatory optionAn FDA-cleared second EIA may be used as the confirmatory assay in place of Western blot.
    Contextual examplesUsed for serologic diagnosis of Lyme disease in patients with compatible clinical presentation (per coverage criteria).
    Policy Summary
    PayerHumana
    PolicyLaboratory — Lyme Disease Testing Coverage Criteria
    Policy CodePolicy LAB2O23037
    Change TypeNo material change
    Effective DateJun 1, 2023
    Last ReviewNov 1, 2024
    Next Review Date
    Key ActionUse a two-tier serologic testing strategy (screening EIA/IFA followed by confirmatory Western blot or FDA-cleared second EIA) and document clinical signs to support reimbursement.
    SourceLink
    On This Page
    Coverage Criteria for Lyme Disease TestingWhen Testing is CoveredApplicable CPT / PLA CodesProvider Actions and DocumentationOrdering RequirementsNot CoveredBackgroundDefinitions
    Documentation Required

    Documentation to support serologic testing

    Document clinical signs or symptoms consistent with Lyme disease and the use of the two‑tier serologic testing strategy (screening EIA/IFA 86618 followed by Western immunoblot or FDA‑cleared second EIA 86617) to support reimbursement.

    • Record clinical presentation such as fever, malaise, neurologic or cardiac manifestations, erythema migrans, or other typical signs.
    • Specify that testing followed the 2‑tier algorithm (86618 then 86617).
    Denial Risk

    Denial risk for molecular tests (87475/87476)

    PCR-based direct detection of Borrelia burgdorferi (87475) is stated as not reimbursable for Medicare Advantage; payment criteria for 87475 and 87476 apply across Medicare jurisdictions except for certain MACs listed in the policy.

    • Do not expect reimbursement for 87475 under Medicare Advantage per this policy.
    • 87476 is also subject to the payment criteria referenced and may not be reimbursable depending on jurisdictional LCDs.