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    OpenPayerPolicy UpdatesInfectious Diseasepartners_health_management Lyme Zika Testing Cover…
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    Currentpartners_health_managementPolicy CONCERT INFECTIOUS DISEASE: VECTOR-BORNE AND TROPICAL DISEASES TESTING

    CONCERT INFECTIOUS DISEASE: VECTOR-BORNE AND TROPICAL DISEASES TESTING

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    Defines medical necessity and coverage criteria for outpatient laboratory testing for Lyme disease (Borrelia burgdorferi) and Zika virus using serologic and molecular methods for members of Partners Health Management plans.

    Policy Summary
    Payerpartners_health_management
    PolicyVector-borne and tropical disease diagnostic testing (Lyme disease and Zika)
    Policy CodePolicy CONCERT INFECTIOUS DISEASE: VECTOR-BORNE AND TROPICAL DISEASES TESTING
    Change TypeNo material changes
    Effective Date
    Last ReviewNov 1, 2024
    Next Review Date
    Key ActionDocument plausible exposure history, relevant symptoms/findings, and how results will influence treatment decisions when ordering tests.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    2conditions covered (Lyme disease, Zika)
    Outpatientintended care setting
    11/2024policy last revised
    No preconceptionscreening stance

    Coverage Criteria — Vector-borne and Tropical Disease Testing

    Lyme Disease — Serum Antibody Testing

    Lyme disease serum antibody testing is medically necessary when ALL of the following are met:

    Lyme antibody criteria: A. Plausible exposure to Borrelia burgdorferi
    Clinical presentation: At least one of: 1) Skin lesion(s) suggestive of, but atypical for erythema migrans; 2) Suspected Lyme neuroborreliosis involving either the peripheral or central nervous system; 3) Suspected Lyme arthritis; 4) Acute myocarditis or pericarditis.

    Lyme Disease — Nucleic Acid/PCR Testing

    Lyme disease nucleic acid/PCR testing is medically necessary when ALL of the following are met:

    Lyme PCR criteria: A. Member is seropositive for Lyme disease
    Clinical suspicion: B. Suspected Lyme arthritis
    Purpose: C. Testing is necessary for making treatment decisions.

    Zika Virus — Nucleic Acid/PCR Testing

    Zika virus nucleic acid/PCR tests are medically necessary when ANY of the following pregnancy/infant scenarios apply:

    Pregnant individual: A. Member is pregnant AND had plausible exposure to Zika virus (e.g., traveled to or lives in an area with transmission or had sexual relations with someone who traveled to or lives in an area with transmission).
    Infant criteria (maternal laboratory evidence): B. Member is 12 months of age or younger AND the member's mother had laboratory evidence of Zika virus infection during pregnancy.
    Infant symptomatic with maternal exposure: C. Member is 12 months of age or younger AND has symptoms of congenital Zika virus infection AND the member's mother had a plausible exposure to Zika virus (regardless of mother's Zika test results).

    Zika Virus — Antibody Testing

    Zika virus antibody tests are medically necessary when ANY of the following apply:

    Pregnant with ultrasound findings: A. Member is pregnant AND prenatal ultrasound findings are consistent with congenital Zika virus infection (e.g., microcephaly, ventriculomegaly, or abnormalities of the corpus callosum) AND had plausible exposure to Zika virus (e.g., traveled to or lives in an area with transmission or had sexual relations with someone who traveled to or lives in an area with transmission).
    Infant criteria (maternal laboratory evidence): B. Member is 12 months of age or younger AND the member's mother had laboratory evidence of Zika virus infection during pregnancy.
    Infant symptomatic with maternal exposure: C. Member is 12 months of age or younger AND has symptoms of congenital Zika virus infection AND the member's mother had a plausible exposure to Zika virus.

    Zika virus maternal IgM testing

    Covered when ALL of the following are met

    Maternal serum IgM testing for pregnant individuals: Pregnant individuals with a female reproductive system who have a fetus with prenatal ultrasound findings consistent with congenital Zika virus infection AND who live in or traveled to areas with a risk of Zika during pregnancy OR had potential sexual exposure to a partner who lives in or traveled to an area with risk of Zika.

    Based on CDC recommendation

    Infant congenital Zika testing

    Covered when ANY of the following are met

    Infant testing for congenital Zika: Infants born to mothers with laboratory evidence of Zika virus infection during pregnancy; OR infants who have abnormal clinical findings suggestive of congenital Zika virus syndrome AND a maternal epidemiologic link suggesting possible transmission (regardless of maternal Zika virus test results).

    Laboratory testing for congenital Zika is recommended per CDC

    Lyme disease serum antibody testing is not supported for screening or evaluation in patients who do not meet the specific clinical criteria. Current evidence does not support testing for: asymptomatic patients following tick bite; patients with erythema migrans; or for a range of neurologic, neurodegenerative, psychiatric, or other non-specific presentations (including typical amyotrophic lateral sclerosis, relapsing-remitting multiple sclerosis, Parkinson's disease, dementia/cognitive decline, new-onset seizures, nonspecific brain MRI white matter abnormalities, psychiatric illness, children with developmental or behavioral disorders, and chronic cardiomyopathy of unknown cause).

    Lyme nucleic acid/PCR testing is not supported when used to diagnose Lyme disease outside the narrow adjunctive scenario described in the criteria. Specifically, PCR testing is only considered medically necessary when the patient is seropositive for Lyme disease, has suspected Lyme arthritis, and the result is necessary for making treatment decisions. Use of PCR for routine diagnosis or broader indications is unsupported.

    The policy identifies several specific Lyme-related tests that are not supported due to lack of independent, reproducible validation. These include: lymphocyte transformation tests, the Lyme Borrelia Nanotrap urine antigen test, and Lyme ImmunoBlot (IgG and IgM). The guidance also cautions against nonstandard serology interpretation, urine antigen testing, DNA testing outside validated methods, and assays such as the quantitative CD57 lymphocyte test.

    Zika nucleic acid amplification (NAAT/PCR) and serologic testing are not supported for symptomatic, non-pregnant patients or for routine preconception or prenatal screening. NAAT/PCR is reserved for specified pregnancy and infant scenarios (e.g., pregnant individuals with plausible exposure and fetal ultrasound findings, or infants ≤12 months with maternal laboratory-confirmed infection or compatible clinical findings). Ordering Zika NAAT or antibody testing outside those indications may be denied.

    Zika virus serologic testing is not recommended for pregnant individuals who do not meet the policy's fetal or epidemiologic criteria. Maternal IgM testing is indicated only when the pregnant individual has a fetus with prenatal ultrasound findings consistent with congenital Zika infection and a plausible epidemiologic exposure (travel or sexual exposure). Routine maternal serology in the absence of these findings or exposures is not supported per CDC guidance.

    Lyme disease serum antibody testing is considered not medically necessary for the unsupported indications listed in the policy. Examples include testing asymptomatic patients after a tick bite, testing for classic erythema migrans, and testing for the specified neurologic, psychiatric, developmental, or chronic cardiomyopathy presentations when the clinical criteria for antibody testing are not met.

    Other Lyme-specific tests are explicitly designated not medically necessary because they lack sufficient validation. The policy lists lymphocyte transformation tests, the Nanotrap urine antigen test, and certain commercial ImmunoBlot methods (e.g., nonstandard or unvalidated IgG/IgM immunoblots such as some IGeneX offerings) among tests that should be avoided for clinical use.

    Zika testing (either NAAT or antibody) is not medically necessary for symptomatic non-pregnant persons, for routine preconception or prenatal screening, or for asymptomatic pregnant individuals who lack both qualifying prenatal ultrasound findings and an epidemiologic link. These restrictions are aligned with CDC recommendations and reflect current epidemiology.

    Given the current epidemiology and CDC guidance, Zika serologic testing is not recommended for preconception screening and is also not recommended for symptomatic non-pregnant patients. Providers ordering such tests for these purposes should expect that testing may be declined or considered not medically necessary.

    Coding — Referenced CPT Codes

    Referenced CPT codes - serology/immunoblotCPT
    0041UBorrelia burgdorferi, antibody detection of 5 recombinant protein groups, by immunoblot, IgM.
    0042UBorrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot, IgG.
    0316UBorrelia burgdorferi (Lyme disease), OspA protein evaluation, urine.
    86617Antibody; Borrelia burgdorferi (Lyme disease) confirmatory test (eg, Western Blot or immunoblot).
    86618Antibody; Borrelia burgdorferi (Lyme disease).
    86794Antibody; Zika virus, IgM.
    Referenced CPT codes - nucleic acid/PCRCPT
    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.
    87662Infectious agent detection by nucleic acid (DNA or RNA); Zika virus, amplified probe technique.
    CPT codes referencedCPT
    0041UBorrelia burgdorferi, antibody detection of 5 recombinant protein groups, by immunoblot, IgM
    0042UBorrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot, IgG
    0316UBorrelia burgdorferi (Lyme disease), OspA protein evaluation, urine
    86617Antibody; Borrelia burgdorferi (Lyme disease) confirmatory test (eg, Western Blot or immunoblot)
    86618Antibody; Borrelia burgdorferi (Lyme disease)
    86794Antibody; Zika virus, IgM
    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
    87662Infectious agent detection by nucleic acid (DNA or RNA); Zika virus, amplified probe technique

    Provider Actions — Documentation, Billing, and Prior Authorization

    Note

    Coding and prior authorization are payer-specific

    Some CPT codes listed in this policy are provided for informational and coding purposes only. Providers must follow payer-specific prior authorization rules and the plan’s prior authorization process when required; inclusion of a code here does not guarantee prior authorization approval or coverage.

    • Codes listed (e.g., 0041U, 0042U, 0316U, 86617, 86618, 86794, 87475, 87476, 87662) are informational only
    • Follow the payer’s prior authorization policy when submitting requests
    Prior Authorization

    Follow coding tables and payer prior authorization rules

    When submitting claims or authorization requests, reference the policy’s CPT code listings but confirm and follow current payer coding tables and prior authorization rules; a code listed here does not guarantee coverage.

    • Verify CPT descriptions and updates before claim submission

    Background — Vector-borne and Tropical Diseases Overview

    Vector-borne diseases are transmitted to humans by arthropod vectors such as ticks and mosquitoes; risk varies by geography, seasonality, and travel history. This policy focuses on outpatient testing for two vector-borne infections—Lyme disease (Borrelia burgdorferi) and Zika virus—and summarizes when serologic and molecular diagnostics are medically necessary based on exposure risk, specific clinical findings, and public health guidance.

    Definitions and Clinical Terms

    inv-32: Definition — Lyme neuroborreliosis
    DefinitionLyme neuroborreliosis: characterized by cranial or peripheral nerve involvement (e.g., facial palsy, radiculoneuropathy) or central nervous system involvement (meningitis/encephalitis).
    Typical presentationsFacial palsy, radiculoneuropathy, meningitis or encephalitis.
    Anatomic systems involvedPeripheral nerves, cranial nerves, and central nervous system.
    inv-33: Definition — Lyme arthritis
    DefinitionLyme arthritis: characterized by obvious swelling of one or more joints and joint pain with movement.
    Typical featuresVisible joint swelling and movement-associated pain, often monoarticular.

    Revision History

    11/2024Annual review / content revisionLatest

    Annual review with minor rewording and formatting; policy statements were reworded from 'may be considered medically necessary' to 'are considered medically necessary' for Lyme and Zika criteria sections; references updated.

    03/2024Technical correction

    Corrected CPT code descriptions and removed CPT 86353 from the CPT table.

    02/2024
    Policy Summary
    Payerpartners_health_management
    PolicyVector-borne and tropical disease diagnostic testing (Lyme disease and Zika)
    Policy CodePolicy CONCERT INFECTIOUS DISEASE: VECTOR-BORNE AND TROPICAL DISEASES TESTING
    Change TypeNo material changes
    Effective Date
    Last ReviewNov 1, 2024
    Next Review Date
    Key ActionDocument plausible exposure history, relevant symptoms/findings, and how results will influence treatment decisions when ordering tests.
    SourceLink
    On This Page
    Coverage Criteria — Vector-borne and Tropical Disease TestingCoding — Referenced CPT CodesProvider Actions — Documentation, Billing, and Prior AuthorizationBackground — Vector-borne and Tropical Diseases OverviewDefinitions and Clinical TermsRevision History
  1. Obtain prior authorization per payer requirements when applicable
    2. Step Therapy

    Prefer serology first; PCR only as adjunctive

    Order serologic (antibody) testing first for suspected Lyme disease; reserve nucleic acid/PCR testing as adjunctive testing only for seropositive patients when PCR on synovial fluid or tissue is required to inform treatment decisions (e.g., suspected Lyme arthritis).

    • Prefer two‑tier serologic antibody testing in most clinical scenarios as per joint society guidance
    • Use PCR only for seropositive patients with suspected Lyme arthritis when results will affect treatment
    Note
    Documentation Required

    Document exposure, symptoms, and intended management

    Document the member’s plausible exposure history and the specific clinical findings that justify testing, such as atypical erythema migrans, signs of neuroborreliosis (cranial or peripheral nerve involvement, meningitis), suspected Lyme arthritis, or acute myocarditis/pericarditis; include how results will influence management.

    • Record travel, tick exposure, or residence in endemic areas
    • Describe the clinical presentation (e.g., atypical skin lesion, neurologic signs, swollen joint)
    • Explain how test results will change treatment decisions
    Documentation Required

    Document maternal exposure and fetal ultrasound findings

    For maternal Zika testing, document maternal epidemiologic exposure (travel to or residence in areas with Zika risk or potential sexual exposure) and include prenatal ultrasound findings consistent with congenital Zika infection when ordering maternal serum IgM testing.

    • Record travel or sexual exposure history during pregnancy
    • Attach prenatal ultrasound findings (e.g., microcephaly, ventriculomegaly, corpus callosum abnormalities)
    Documentation Required

    Document maternal lab evidence or epidemiologic link for infant testing

    When ordering congenital Zika testing for an infant, document either maternal laboratory evidence of Zika infection during pregnancy or a maternal epidemiologic link (travel/exposure) and the infant’s clinical findings suggestive of congenital Zika.

    • Include maternal laboratory test results if available
    • Document infant symptoms or abnormal clinical findings consistent with congenital Zika syndrome
    Denial Risk

    Avoid antibody testing for unsupported Lyme indications

    Do not order Lyme disease serum antibody testing for unsupported scenarios—these are likely to be denied—such as asymptomatic patients after a tick bite, testing for erythema migrans, or for non-specific neurologic, psychiatric, or chronic conditions listed in the policy.

    • Asymptomatic after tick bite
    • Typical erythema migrans
    • Neurologic/psychiatric conditions (e.g., ALS, MS, Parkinson’s, dementia, new‑onset seizures, nonspecific MRI white matter changes)
    • Children with developmental/behavioral disorders; chronic cardiomyopathy of unknown cause
    Denial Risk

    PCR for Lyme is restricted to adjunctive use

    Lyme nucleic acid/PCR testing ordered outside the specified adjunctive scenario (i.e., for routine diagnosis rather than for seropositive patients with suspected Lyme arthritis where PCR informs treatment) may be denied.

    • PCR is covered only when the member is seropositive, has suspected Lyme arthritis, and testing will affect treatment
    • PCR for general diagnosis of Lyme disease is unsupported
    Denial Risk

    Do not use Zika NAAT for symptomatic non‑pregnant or routine screening

    Zika NAAT (nucleic acid/PCR) testing is not supported—and may be denied—for symptomatic non‑pregnant individuals or for routine preconception or prenatal screening; order NAAT only for the pregnancy/infant scenarios specified in the policy.

    • Not supported for symptomatic non‑pregnant members
    • Not supported for routine preconception or prenatal screening
    Denial Risk

    Zika antibody testing is limited to specified indications

    Zika antibody testing is not supported for individuals outside the policy’s specified indications (including symptomatic or asymptomatic pregnant or non‑pregnant persons without the required ultrasound findings or epidemiologic link) and may be denied.

    • Not supported for symptomatic or asymptomatic pregnant individuals without fetal ultrasound findings and exposure
    • Not supported for symptomatic non‑pregnant individuals under current epidemiology
    • Do not use for routine preconception screening
    Denial Risk

    Preconception Zika testing is not recommended

    Ordering Zika serologic testing for preconception screening is not recommended by CDC and may trigger coverage denial; avoid preconception Zika antibody testing absent specific indications.

    • CDC does not recommend Zika testing for preconception screening
    • Preconception orders may be considered not medically necessary
    Clinical relevanceUsed to identify patients for adjunctive nucleic acid/PCR testing when seropositive and treatment decisions require confirmation.
    inv-34: Definition — Congenital Zika virus infection
    DefinitionCongenital Zika virus infection: syndrome with severe microcephaly (sometimes with craniofacial malformation), decreased brain tissue with characteristic damage (including subcortical calcifications), ocular abnormalities (macular scarring, retinal pigmentary mottling), congenital contractures (eg, clubfoot, arthrogryposis), and hypertonia with restricted movement.
    Neurologic and structural findingsSevere microcephaly, decreased brain tissue with pattern of damage, subcortical calcifications.
    Ocular and musculoskeletal findingsMacular scarring, focal retinal pigmentary mottling, congenital contractures such as clubfoot or arthrogryposis.
    inv-35: Definition — Maternal epidemiologic link
    DefinitionMaternal epidemiologic link: history of living in or travel to areas with risk of Zika virus transmission during pregnancy, or potential sexual exposure to a partner who lived in or traveled to an area with Zika risk.
    Examples of exposureTravel or residence in areas with Zika transmission during pregnancy; sexual exposure to a partner from such an area.
    Documentation neededRecord of travel/residence or sexual exposure when ordering maternal or infant testing for congenital Zika.
    inv-36: Definition — Congenital Zika testing indication for infant
    IndicationInfant congenital Zika testing is indicated for infants born to mothers with laboratory evidence of Zika virus infection during pregnancy, or for infants with abnormal clinical findings suggestive of congenital Zika syndrome plus a maternal epidemiologic link, regardless of maternal test results.
    Age limitApplies to infants 12 months of age or younger in policy criteria for testing.
    Clinical triggersAbnormal clinical findings consistent with congenital Zika (see congenital Zika definition) together with a maternal epidemiologic link.
    Title and coding update

    Added 'lab' to the policy title, removed CPT and ICD-10 codes from the policy reference table, and added a CPT code table and coding section.

    11/23Policy development / external review

    Policy developed and externally specialist reviewed.