CurrentHumanaPolicy LAB2023037

Laboratory - Lyme Disease

Humana Medicare Advantage payment policy describing reimbursable and non-reimbursable laboratory tests for Borrelia burgdorferi (Lyme disease) and the clinical indications that support serologic testing; applies to Humana Medicare Advantage providers.

Policy Summary

PayerHumana

PolicyLaboratory - Lyme Disease

Policy CodePolicy LAB2023037

Change TypeNo material change

Effective Date06/2023

Next Review Date12/2025

Key ActionPerform two-tier serologic testing (sensitive EIA/IFA followed by western immunoblot or FDA-cleared second EIA) when clinical presentations suggest possible Lyme disease; do not bill for nucleic acid tests or certain proprietary urine antigen tests.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2-tier2-tier testing reimbursed

Not reimbursableNucleic acid tests

Not reimbursableProprietary urine test

Medicare AdvantageApplies to

Coverage Criteria for Lyme Disease Testing

Reimbursable serologic testing criteria

Two-tier serologic testing is reimbursable when performed for specified clinical presentations consistent with possible Lyme disease.

ALL of the following

ANY of the following
- Acute cranial neuropathy
- Acute myocarditis, pericarditis or cardiomyopathy
- Ataxia
- Cough or shortness of breath

Policy Summary

PayerHumana

PolicyLaboratory - Lyme Disease

Policy CodePolicy LAB2023037

Change TypeNo material change

Effective Date06/2023

Next Review Date12/2025

SourceLink

On This Page

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Non-covered tests

The policy explicitly excludes reimbursement for certain molecular and proprietary tests.

ALL of the following

CPT 87475 — Nucleic acid testing to detect Borrelia burgdorferi (direct probe) is not reimbursable.
CPT 87476 — Nucleic acid testing to detect Borrelia burgdorferi (amplified probe) is not reimbursable.
CPT 0316U — OspA urine antigen test (e.g., Nanotrap®) and other specified proprietary tests for Borrelia burgdorferi are not reimbursable.

Relevant CPT / HCPCS / Proprietary Codes

Covered CPT/HCPCS CodesmixedCovered

86618	Antibody; Borrelia burgdorferi (Lyme disease) - sensitive EIA/IFA
86617	Antibody; Borrelia burgdorferi (Lyme disease) confirmatory test (e.g., Western Blot or immunoblot)
0041U	Borrelia burgdorferi, antibody detection of 5 recombinant protein groups, by immunoblot, IgM
0042U	Borrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot, IgG

Not covered / Experimental CodesmixedNot Covered

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
0316U	Borrelia burgdorferi (Lyme disease), OspA protein evaluation, urine (Lyme Borrelia Nanotrap®)

Provider Actions and Reimbursement Guidance

Prior Authorization

Prior authorization / reimbursement actions: Two‑tier serologic testing reimbursable for specified clinical presentations; select tests not reimbursable

Serologic two-tier testing (a sensitive EIA/IFA followed by a western immunoblot or an FDA‑cleared second EIA) is reimbursable only when performed for clinical presentations consistent with possible Lyme disease, specifically: acute cranial neuropathy; acute myocarditis, pericarditis or cardiomyopathy; ataxia; cough or shortness of breath; fever, malaise, chills, fatigue or myalgia; meningitis, encephalitis or myelitis; mononeuropathy multiplex; painful radiculoneuritis; or urticaria. Nucleic acid tests (CPT 87475, 87476) and other proprietary tests (CPT 0316U) are not reimbursable.

Use CPT 86618 as the initial sensitive EIA/IFA when two-tier testing is indicated.
Follow a positive or equivocal initial EIA/IFA with CPT 0041U or 0042U (western immunoblot) or CPT 86617 (FDA‑cleared second EIA) as the confirmatory test.
Do not submit or expect reimbursement for nucleic acid tests CPT 87475 or 87476, or for CPT 0316U.

Definitions and Test Methodology

inv-05: Two-tier serologic testing

DefinitionTwo-tier serologic testing: a sensitive enzyme immunoassay (EIA) or immunofluorescence assay (CPT 86618) followed by a western immunoblot assay (CPT 0041U or CPT 0042U) or an FDA-cleared second EIA (CPT 86617).

Initial test (sensitive EIA/IFA)CPT 86618 — Antibody; Borrelia burgdorferi (Lyme disease) (sensitive EIA or IFA).

Confirmatory test (western immunoblot)CPT 0041U / CPT 0042U — Borrelia burgdorferi antibody detection by immunoblot (IgM/IgG recombinant protein groups).

FDA‑cleared alternativeCPT 86617 — Antibody; Borrelia burgdorferi confirmatory test (e.g., Western blot or FDA‑cleared second EIA).

inv-06: Nucleic acid testing (NAT)

DefinitionNucleic acid testing (NAT): molecular detection methods for Borrelia burgdorferi (direct or amplified probe techniques).

CPT 87475Infectious agent detection by nucleic acid (DNA or RNA); Borrelia burgdorferi, direct probe technique — listed as not reimbursable for Medicare Advantage.

CPT 87476Infectious agent detection by nucleic acid (DNA or RNA); Borrelia burgdorferi, amplified probe technique — listed as not reimbursable for Medicare Advantage.