Vector-borne and tropical disease testing — Lyme disease and Zika virus (serologic and molecular testing)
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Outpatient coverage criteria for serologic and molecular testing for Lyme disease and Zika virus, including medically necessary indications and excluded tests.
Reworded policy statements from 'may be considered medically necessary' to 'are considered medically necessary' for Lyme and Zika testing sections.
Added CPT code table and moved the 'coding implications' section.
Removed CPT and ICD-10 codes from policy reference table.
Coverage Criteria — Lyme disease and Zika virus testing
Lyme Disease (Borrelia burgdorferi) Serum Antibody Tests
Covered when ALL of the following are met:
Lyme Disease (Borrelia burgdorferi) Nucleic Acid/PCR Tests
Covered when ALL of the following are met:
Zika Virus Nucleic Acid/PCR Tests
Covered when ANY of the following groups are met:
Zika Virus Antibody Tests
Covered when ANY of the following groups are met:
Current evidence does not support testing for Lyme or Zika for a number of other indications. For Lyme disease serum antibody testing and Lyme nucleic acid/PCR testing, examples of indications not supported include: asymptomatic patients following a tick bite, testing for classic erythema migrans, and use for routine evaluation of neurologic or neurodegenerative disorders such as typical amyotrophic lateral sclerosis, relapsing-remitting multiple sclerosis, Parkinson's disease, dementia/cognitive decline, or new-onset seizures. Lyme testing is also not supported for nonspecific MRI white matter abnormalities, psychiatric illness, children with developmental or behavioral disorders, or chronic cardiomyopathy of unknown cause. For Zika virus testing, nucleic acid/PCR and antibody testing are not supported for symptomatic, non-pregnant patients and for routine pre-conception or prenatal screening. These exclusions align with the clinical indications listed for when testing is considered medically necessary and reflect limited evidence for benefit outside those scenarios.
State Medicaid coverage provisions and other legal or regulatory requirements take precedence over this clinical policy when there is any conflict. Coverage decisions and benefit administration remain subject to the specific terms, conditions, exclusions and limitations of the member's coverage documents and applicable state and federal requirements; this policy is a guide to medical necessity but does not guarantee payment.
The following specific tests are identified as not supported by current evidence and therefore considered not medically necessary: lymphocyte transformation tests, the Lyme Borrelia Nanotrap Urine Antigen Test, and Lyme ImmunoBlot IgG and Lyme ImmunoBlot IgM assays.
Coding and Billing
| 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 |
| 0316U | Borrelia burgdorferi (Lyme disease), OspA protein evaluation, urine |
| 86617 | Antibody; Borrelia burgdorferi (Lyme disease) confirmatory test (eg, Western Blot or immunoblot) |
| 86618 | Antibody; Borrelia burgdorferi (Lyme disease) |
| 86794 | Antibody; Zika virus, IgM |
| 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 |
| 87662 | Infectious agent detection by nucleic acid (DNA or RNA); Zika virus, amplified probe technique |
Provider Actions, Prior Authorization, and Documentation
Confirm coding and prior authorization requirements
Codes listed in the policy's CPT/HCPCS table (e.g., 0041U, 0042U, 0316U, 86617, 86618, 86794, 87475, 87476, 87662) are included for informational purposes only. Providers must confirm the exact procedure codes to bill and check whether the member's plan requires prior authorization for those specific codes before submitting claims.
Verify prior authorization per member coverage
This clinical policy is a guide to medical necessity determinations used in coverage decisions. Providers should verify whether prior authorization is required for the member per the member's coverage documents and the Health Plan's administrative procedures.
- Policy guides medical necessity but does not replace plan-level authorization rules
- Check member-specific coverage documents and Health Plan procedures for prior authorization
Reserve Lyme PCR as adjunctive testing for seropositive patients
PCR (nucleic acid) testing for Lyme disease is generally reserved as an adjunct to serology: it is considered medically necessary only when the patient is seropositive, Lyme arthritis is suspected, and PCR results are necessary to make treatment decisions.
- Indications: seropositive for Lyme disease AND suspected Lyme arthritis AND testing necessary for treatment decisions
- IDSA/AAN/ACR guidance: PCR primarily beneficial as adjunctive testing when 2‑tiered serology is positive and recommended for synovial fluid in seropositive patients with possible Lyme arthritis
Match test orders to policy-listed indications
Ensure any test request corresponds to a listed medically necessary indication in this policy before ordering or billing; unsupported indications risk denial or nonpayment.
- Order tests only when the coverage criteria for Lyme or Zika in this policy are met
- Unsupported indications include asymptomatic post-tick bite, routine prenatal screening, and symptomatic non-pregnant Zika patients
Include exposure and indication-specific clinical documentation
Clinical documentation must support plausible exposure epidemiology and the specific indications required by the policy (for example, atypical erythema migrans descriptions, neurologic findings consistent with Lyme neuroborreliosis, evidence of maternal Zika infection during pregnancy, or prenatal ultrasound findings consistent with congenital Zika).
- Document plausible exposure (travel, residence in transmission area, or sexual exposure) where required
- For Lyme: describe skin lesions, neurologic signs, or joint findings as applicable
- For Zika: include maternal laboratory evidence or prenatal ultrasound findings when indicated
Follow plan and regulatory requirements for claims submission
When submitting claims, follow the member's plan coverage documents and applicable state and federal requirements; this clinical policy provides medical necessity guidance but does not guarantee payment.
- Adhere to Health Plan billing and administrative policies and procedures
- Policy guidance does not supersede contract terms or regulatory requirements
Potential denial for non-indicated tests
Requests for Lyme or Zika testing that do not meet the policy's medical necessity indications are likely to be denied—for example, testing asymptomatic patients after a tick bite, routine prenatal or pre-conception screening, or testing symptomatic non-pregnant patients for Zika.
- Asymptomatic post‑tick bite testing is not supported
- Routine pre-conception or prenatal screening is not supported
- Symptomatic, non-pregnant Zika testing is not supported
Coverage subject to plan terms and legal requirements
Coverage decisions and benefit administration remain subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and to state and federal requirements; the policy is a guide and does not alter contractual provisions.
- Evidence of Coverage, certificate of coverage, policy, or contract terms govern payment
- State Medicaid provisions take precedence where they conflict with this policy
Background
Vector-borne diseases such as Lyme disease and Zika virus are transmitted by arthropod vectors (ticks for Borrelia burgdorferi; mosquitoes and sexual/vertical exposure routes for Zika) and their clinical risk depends on exposure history, geography, seasonality, and travel. This policy focuses on outpatient serologic and molecular testing for these infections and restricts testing to clinical scenarios supported by evidence — for example, Lyme testing for plausible exposure plus specific clinical syndromes (atypical skin lesions, suspected neuroborreliosis, arthritis, or myocarditis/pericarditis) and Zika testing primarily for pregnant persons or infants with possible congenital infection.
Definitions
Revision History
Annual review with minor rewording and formatting; policy statements reworded from 'may be considered medically necessary' to 'are considered medically necessary' for Lyme and Zika testing sections; references updated.
Annual review noting previous corrections; corrected March 2024 revision log regarding removal of CPT 86353 and added policy number to header; minor rewording and formatting with no clinical significance.
Corrected CPT code descriptions and removed CPT 86353 from the CPT table.
Added CPT code table and moved the 'coding implications' section; removed CPT and ICD-10 codes from the policy reference table.
Policy developed and externally specialist reviewed (Revision Date = 11/23).
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