CurrentHumanaPolicy LAB2023037

Laboratory - Lyme Disease testing and reimbursement

This Humana Medicare Advantage payment policy explains reimbursement rules for laboratory testing for Borrelia burgdorferi (Lyme disease) for Medicare Advantage members, specifying which serologic and molecular tests are reimbursable or not and referencing applicable LCDs and code descriptions.

Policy Summary

PayerHumana

PolicyLaboratory - Lyme Disease testing and reimbursement

Policy CodePolicy LAB2023037

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionReimburse two-tier serologic testing (EIA 86618 followed by immunoblot 0041U/0042U or second EIA 86617); do not reimburse nucleic acid testing (87475/87476) or CPT 0316U.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2-tierTwo-tier serologic testing reimbursable

87475/87476Nucleic acid testing not reimbursable

0316UOther proprietary tests not reimbursable

MedAdvApplies to Medicare Advantage

Coverage Criteria and Exclusions

Coverage criteria and exclusions

Humana reimburses two‑tier serologic testing for specified clinical indications; nucleic acid and certain proprietary tests are not reimbursable. Original Medicare LCDs apply to molecular testing.

ALL of the following

Two-tier serologic testing is reimbursable when ANY of the following clinical indications are present:
- Acute cranial neuropathy
- Acute myocarditis, pericarditis or cardiomyopathy
- Ataxia
- Cough or shortness of breath

Policy Summary

PayerHumana

PolicyLaboratory - Lyme Disease testing and reimbursement

Policy CodePolicy LAB2023037

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionReimburse two-tier serologic testing (EIA 86618 followed by immunoblot 0041U/0042U or second EIA 86617); do not reimburse nucleic acid testing (87475/87476) or CPT 0316U.

SourceLink

On This Page

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Relevant CPT/HCPCS and Proprietary Codes

Lyme disease relevant codesmixed

86618	Antibody; Borrelia burgdorferi (Lyme disease) (sensitive EIA or 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 (Lyme ImmunoBlot IgM)
0042U	Borrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot, IgG (Lyme ImmunoBlot IgG)
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® Urine Antigen Test)

Reimbursement Actions and Billing Guidance

Billing Rule

Reimbursement actions for Lyme disease testing

Two-tier serologic testing for Lyme disease is reimbursable when performed as: an initial sensitive enzyme immunoassay (EIA) or immunofluorescence assay (CPT 86618) followed by either a western immunoblot assay (CPT 0041U, 0042U) or an FDA-cleared second EIA (CPT 86617). Molecular testing (nucleic acid amplification) for Borrelia burgdorferi (CPT 87475, 87476) and other proprietary/non-recommended tests (e.g., CPT 0316U) are not reimbursable. Submit claims using the appropriate CPT codes for the two-tier algorithm and ensure clinical indication aligns with covered conditions (examples include 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; urticaria). Claims for non‑reimbursable tests may be denied.

Covered two-tier sequence: CPT 86618 → CPT 0041U/0042U or CPT 86617
Not reimbursable: CPT 87475, CPT 87476 (nucleic acid testing)
Not reimbursable: CPT 0316U (other Borrelia testing)
Clinical indications must match covered conditions listed in policy

Testing Definitions

inv-04: Two-tier serologic testing (definition)

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

SequenceInitial screening with a sensitive EIA/IFA (CPT 86618) with reflex to confirmatory testing only if initial EIA/IFA is reactive or equivocal.

Confirmatory optionsWestern immunoblot: CPT 0041U (IgM) and CPT 0042U (IgG); or FDA-cleared second EIA: CPT 86617.

Clinical contextReimbursable when used for listed clinical indications such as acute cranial neuropathy, meningitis/encephalitis/myelitis, acute myocarditis/pericarditis/cardiomyopathy, ataxia, painful radiculoneuritis, mononeuropathy multiplex, cough/shortness of breath, fever/malaise/chills/fatigue/myalgia, or urticaria.

inv-05: Non-reimbursable molecular and proprietary tests

Policy stanceNucleic acid testing to detect Borrelia burgdorferi (CPT 87475, CPT 87476) is not reimbursable for Medicare Advantage members.

Proprietary testsOther proprietary or non-standard assays for Borrelia burgdorferi (example: CPT 0316U) are not reimbursable.

Relationship to LCDsOriginal Medicare LCDs for molecular testing are referenced and applicable where established; however, per this policy molecular tests listed are not reimbursable for Medicare Advantage.

Implication for claimsClaims submitted for CPT 87475, 87476, or CPT 0316U should be expected to be denied/not reimbursed under this Medicare Advantage policy.