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Lyme Disease Testing Coverage Criteria
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Defines coverage, indications, limitations, and acceptable testing methodologies for laboratory diagnosis of Lyme disease for Oscar Health members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Lyme Disease Testing
Medically necessary indications for serologic testing
Covered when ANY of the following clinical scenarios apply and testing follows a two-tier serologic algorithm (STTT) or an FDA-cleared MTTT:
Serologic testing must use a sensitive EIA/IFA first-step followed by a western immunoblot confirmatory test or an FDA-cleared second EIA (MTTT).
Repeat testing timing
Repeat testing:
Perform repeat testing per two-tier algorithm (EIA/IFA first; if positive/equivocal, perform confirmatory immunoblot or FDA-cleared second EIA).
Not medically necessary / Excluded indications
Not covered (testing DOES NOT MEET CRITERIA) in the following situations:
These exclusions reflect lack of benefit, high false-positive risk, or absence of validation in published literature.
Appropriate and Inappropriate Testing (Guideline-driven)
Coverage aligned with major guidelines — testing appropriate when clinical and epidemiologic context supports suspicion of Lyme disease; otherwise not recommended.
Results are considered positive only if both steps are positive.
Recommendations based on IDSA/AAN/ACR, AAP, CDC, and NICE guidance.
Strong recommendation in IDSA/AAN/ACR guidance.
Multiple guideline recommendations cite high false-positive risk and low utility.
Guidance and evidence note variable sensitivity of molecular methods (AAP, IDSA statements).
Proprietary and other nonstandard Lyme disease assays are considered unsupported for routine diagnostic use unless they align with accepted, validated methodologies. Examples called out in the policy include proprietary immunoblots and laboratory-developed assays that have limited independent validation, as well as nonstandard specimen types such as urine-based assays. The AAP and other authorities note that several commercially available tests lack broad validation and therefore are not appropriate as substitutes for the recommended serologic algorithms. When reporting or billing for proprietary or LDT assays, include the test name and performing laboratory per documentation requirements.
Certain tests have been specifically identified as invalid or too nonspecific for diagnosis and therefore do not meet criteria. These include urine tests for Borrelia burgdorferi, the CD57 assay, novel culture techniques, and antibody panels that deviate from the standardized two-tier testing approach. The policy references AAP guidance stating these assays are not FDA-cleared and are not appropriate diagnostic tests because they can produce false-positive or otherwise uninterpretable results.
None explicitly stated in these chunks.
Serologic testing is not medically necessary for patients with a classic erythema migrans rash because this presentation should be diagnosed clinically without laboratory testing. The policy follows guideline recommendations that clinicians treat typical EM without reliance on serology. In addition, serology is not indicated for isolated neurologic or psychiatric complaints in the absence of other objective signs or epidemiologic exposure consistent with Lyme disease.
Routine testing of asymptomatic individuals after a tick bite is discouraged and considered not medically necessary. Likewise, routine screening for nonspecific neurologic, psychiatric, or chronic conditions (for example ALS, MS, Parkinson’s disease, dementia, new-onset seizures, or nonspecific MRI white-matter changes) is not recommended and does not meet criteria unless other clinical or epidemiologic evidence supports testing.
No explicit 'not medically necessary' statements are specified in these specific code-list chunks.
Coding and Procedure Codes
| 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 test: Lyme ImmunoBlot IgM, IGeneX Inc). |
| 0042U | Borrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot, IgG (Proprietary test: Lyme ImmunoBlots IgG, IGeneX Inc). |
| 0580U | Borrelia burgdorferi, antibody detection of 24 recombinant protein groups, by immunoassay, IgG (Proprietary test: iDartTM Lyme IgG ImmunoBlot Kit, ID-FISH Technology, Inc). |
| 0615U | Borrelia burgdorferi (Lyme disease), antibody detection of 26 recombinant protein groups, by immunoassay, IgM (Test Name: iDart ™ Lyme IgM ImmunoBlot Kit, ID-FISH Technology, Inc). |
| 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 test: Lyme ImmunoBlot IgM; Lab/Manufacturer: IGeneX Inc). |
| 0042U | Borrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot, IgG (Proprietary test: Lyme ImmunoBlots IgG; Lab/Manufacturer: IGeneX Inc). |
| 0580U | Borrelia burgdorferi, antibody detection of 24 recombinant protein groups, by immunoassay, IgG (Proprietary test: iDartTM Lyme IgG ImmunoBlot Kit; Lab/Manufacturer: ID-FISH Technology, Inc). |
| 0615U | Borrelia burgdorferi (Lyme disease), antibody detection of 26 recombinant protein groups, by immunoassay, IgM (Test Name: iDart ™ Lyme IgM ImmunoBlot Kit; Laboratory: ID-FISH Technology, Inc). |
Provider Actions, Documentation, and Billing Guidance
Authorization note — confirm coverage before ordering
Coverage for serologic two-tier testing (STTT) or an FDA-cleared modified two-tier testing (MTTT) meets criteria when clinical indications align with the policy; providers should confirm member benefit coverage and any authorization requirements prior to ordering testing.
Codes referenced for authorization checks
When checking prior authorization or adjudicating claims, verify services are billed with the policy-listed CPT/HCPCS/PLA codes; these are the codes referenced throughout the policy for authorization and coverage review.
Preferred testing algorithm (STTT or FDA‑cleared MTTT)
The policy accepts a two-step serologic algorithm (screening EIA/IFA followed by immunoblot) or an FDA-cleared MTTT (an EIA followed by a second FDA-cleared EIA) as the approved testing pathway for serologic diagnosis of Lyme disease.
- STTT: screening EIA/IFA then confirmatory western immunoblot
- MTTT: first EIA then FDA-cleared second EIA as alternative to immunoblot
CDC two-step testing requirement
Follow CDC guidance: perform an initial EIA or IFA and only perform the second-step immunoblot if the first-step result is positive or indeterminate; if the first-step is negative, no further testing of that specimen is recommended.
- First step: EIA or, rarely, IFA
- If first step negative — do not perform further testing on that specimen
- If first step positive or equivocal — perform immunoblot (or FDA-cleared alternative)
Required clinical documentation to justify testing
Providers must submit documentation that supports epidemiologic exposure, clinical signs/symptoms consistent with Lyme disease, and timing (e.g., early versus later disease) to justify serologic testing under the policy.
- History of travel to or residence in an endemic area or known tick/environmental exposure
- Signs/symptoms matching covered clinical scenarios (e.g., meningitis, radiculoneuritis, acute cranial neuropathy, myocarditis/pericarditis)
- Timing of symptom onset relative to exposure and prior testing
Specimen and documentation for suspected neuroborreliosis
For suspected Lyme neuroborreliosis, obtain simultaneous CSF and serum samples and document that a CSF:serum antibody index will be determined by a laboratory using validated methodology; avoid CSF serology without the antibody index.
- Collect CSF and serum at the same time for CSF:serum antibody index
- Specify that the laboratory will use validated methods to determine the index
LDT validation and performing laboratory identification
Laboratory-developed tests (LDTs) for Lyme disease are CLIA-regulated as high-complexity tests; laboratories must validate and perform these LDTs in-house and the performing lab/test name should be included when submitting claims for proprietary or LDT assays.
- LDTs are regulated under CLIA as high-complexity tests
- LDTs are not necessarily FDA-cleared; labs must validate them and identify the performing lab on reports/claims
Denial triggers and non-covered indications
Claims may be denied or recouped if coding/billing guidelines or reimbursement policies are not followed; serologic testing is not covered for erythema migrans, asymptomatic screening, testing the tick, repeat serology after a prior positive, or other non‑described methods.
- Serologic testing not covered for individuals with erythema migrans
- Not covered for asymptomatic screening or testing the tick
- Repeat serology after prior positive is not covered
Adhere to two-step testing — do not confirm after negative first step
If the first-step EIA/IFA is negative, do not order confirmatory immunoblot or further testing on that specimen — doing so may trigger denial as the CDC and policy advise no further testing when first-step is negative.
- Negative first-step EIA/IFA → specimen considered seronegative; no further testing indicated
- If first-step is equivocal or positive → proceed to second-step confirmatory testing
Coding-based denial risk — bill with listed codes
Use only the policy-listed CPT/HCPCS/PLA codes when billing Lyme disease laboratory testing; services billed outside these described codes may be denied or paid incorrectly.
Background and Epidemiology
Lyme disease in North America is caused primarily by Borrelia burgdorferi and is transmitted by infected Ixodes ticks. Early localized infection commonly presents with erythema migrans and non-specific viral-type symptoms; without treatment, infection can disseminate to involve the nervous system, heart, or joints. Serologic testing detects the host antibody response and is most sensitive in later stages; direct detection methods such as PCR have limited sensitivity in blood and are used selectively (for example, PCR of synovial fluid in suspected Lyme arthritis). Because antibody development may take weeks, serology is less sensitive in very early disease, and clinical judgment (including diagnosis of EM) should guide management.
Definitions and Abbreviations
Revision History and Governance
Policy effective date published for Lyme Disease Testing.
Original documentation created and governance-approved for the Lyme Disease Testing policy.
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