CurrentWellCarePolicy N/A

CONCERT INFECTIOUS DISEASE: VECTOR-BORNE AND TROPICAL DISEASES TESTING

Outpatient clinical coverage criteria for laboratory testing (serologic and nucleic acid/PCR) for Lyme disease (Borrelia burgdorferi) and Zika virus, specifying medically necessary indications and tests considered not supported by current evidence.

Policy Summary

PayerWellCare

PolicyCONCERT INFECTIOUS DISEASE: VECTOR-BORNE AND TROPICAL DISEASES TESTING

Policy CodePolicy N/A

Change TypeFormatting/administrative (no material clinical changes)

Effective Date

Next Review Date

Key ActionDocument plausible exposure and the specific clinical indication to support medical necessity and obtain required prior authorization per the Health Plan before performing covered tests.

POLICY UPDATE CHANGES

Reworded policy statements from 'be considered medically necessary' to 'are considered medically necessary' for the listed sections.

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

2Diseases covered (Lyme, Zika)

4Lyme supported test scenarios

4Explicitly not supported tests listed

Coverage Summary

Outpatient coverage criteria for laboratory testing for Lyme disease (Borrelia burgdorferi) and Zika virus, addressing both serologic (antibody/IgM/IgG) and nucleic acid/PCR (NAAT) testing modalities. The policy references the IDSA/AAN/ACR 2020 guidance for Lyme disease and CDC Zika guidance (2024) for Zika testing to define medically necessary indications and limits on testing.

Medical Necessity Criteria (grouped by test and intent)

Lyme Disease (Borrelia burgdorferi) Serum Antibody Tests - Medically Necessary

Serum antibody testing is considered medically necessary when ALL of the following are met:

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Not Supported and Non-covered Tests

The policy does not support broad diagnostic use or routine screening: Lyme and Zika testing are limited to the specific medically necessary scenarios listed in the policy and are not supported for general diagnostic or screening purposes. For Lyme disease, the policy’s Not Supported criteria include asymptomatic patients after a tick bite, typical erythema migrans, and multiple neurologic, psychiatric, cardiomyopathy, and pediatric developmental indications, and it explicitly lists non-covered Lyme tests such as Lymphocyte transformation tests; Lyme Borrelia Nanotrap Urine Antigen Test; Lyme ImmunoBlot IgG; and Lyme ImmunoBlot IgM. For Zika, NAAT/PCR and antibody testing are not supported for symptomatic non-pregnant persons or for routine pre-conception or prenatal screening.

Non-covered Lyme tests (explicitly listed)mixedNot Covered

unspecified	Lymphocyte transformation tests (listed as not supported)
unspecified	Lyme Borrelia Nanotrap Urine Antigen Test (listed as not supported)
unspecified	Lyme ImmunoBlot IgG (listed as not supported)
unspecified	Lyme ImmunoBlot IgM (listed as not supported)

Coding

CPT codes referenced in policyCPT

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)
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

Per the policy change log, CPT code 86353 was removed and CPT/ICD-10 codes were removed from the policy reference table with a separate CPT code table added; these coding changes are noted as administrative/coding updates rather than clinical coverage changes.

Provider Actions and Operational Requirements

Documentation Required

Document plausible exposure and clinical indication

Document the patient’s plausible exposure risk and the specific clinical indication to support medical necessity for Lyme or Zika testing.

Exposure: travel, residence in area with transmission, or sexual exposure risk
Clinical indications: suspected Lyme neuroborreliosis (cranial/peripheral nerve or CNS involvement)
Atypical erythema migrans (skin lesion suggestive of, but atypical for, erythema migrans)
Suspected Lyme arthritis (joint swelling and pain with movement)
Acute myocarditis or pericarditis of unknown cause in appropriate epidemiologic setting
Prenatal ultrasound findings consistent with congenital Zika infection (e.g., corpus callosum abnormality)

Documentation Required

Seropositivity requirement for Lyme PCR

For Lyme nucleic acid/PCR testing (CPT 87475, 87476) in the setting of suspected Lyme arthritis, document that the patient is seropositive for Lyme disease and that PCR testing is necessary to inform treatment decisions.

Affected CPT codes: 87475, 87476
Requirement: patient is seropositive for Lyme disease
Requirement: PCR is necessary to guide treatment decisions for suspected Lyme arthritis

Prior Authorization

Prior authorization may be required per plan

Prior authorization may be required by the member’s Health Plan. Obtain any required prior authorization per the Health Plan’s processes before performing covered tests.

Denial Risk

Claims at risk of denial if outside indications

Claims for Lyme or Zika testing that do not meet the policy’s specified medically necessary criteria are at risk of denial.

Asymptomatic patients following a tick bite (Lyme serology not supported)
Routine screening or testing for typical erythema migrans (Lyme serology not supported — clinical diagnosis recommended)
Symptomatic, non-pregnant individuals for Zika NAAT/PCR or serology (not supported by current evidence)

Background and Evidence

Background: The policy aligns with the 2020 IDSA/AAN/ACR Lyme disease guidelines (favoring serologic testing and recommending against broad nonvalidated tests) and with CDC Zika guidance (2024) that limits testing in pregnant persons and infants. Testing prioritization in the policy emphasizes serology as the primary approach for Lyme disease, with PCR/NAAT reserved for seropositive patients when evaluating suspected Lyme arthritis and when results will affect treatment decisions. For Zika, testing is restricted primarily to pregnant persons with plausible exposure and relevant ultrasound findings and to infants ≤12 months with congenital findings or maternal laboratory evidence of infection.

Reference	Role
IDSA/AAN/ACR 2020 Guidelines	Supports recommended and not-recommended testing scenarios for Lyme disease; recommends serum antibody testing in specified clinical scenarios and limits PCR to seropositive patients when evaluating Lyme arthritis
CDC Zika guidance (2024)	Guides limited testing for pregnant persons and infants; advises against routine screening and against testing symptomatic non-pregnant persons in current epidemiology

Definitions

Lyme neuroborreliosisCranial or peripheral nerve involvement (facial palsy, radiculoneuropathy) or central nervous system involvement (meningitis/encephalitis).

Lyme arthritisObvious swelling of one or more joints and joint pain with movement.

Congenital Zika virus infectionSyndrome with severe microcephaly, decreased brain tissue with subcortical calcifications, ocular damage, congenital contractures, and hypertonia.

Revision History

02/24formatting/administrative

Added 'lab' to policy title; removed CPT and ICD-10 codes from the policy reference table and added a CPT code table; moved the 'coding' implications section. (Not a clinical change; material=false.)

03/24administrative/coding

Corrected CPT code descriptions and removed CPT 86353 from the CPT table. (Administrative/coding update; material=false.)

11/24editorial/formatting

Annual review with minor rewording and formatting with no clinical significance; reworded policy statements from 'be considered medically necessary' to 'are considered medically necessary' for Lyme (serology and PCR) and Zika (antibody and NAAT/PCR) sections. (Material=false.)

02/25approval/administrativeLatest

Approval recorded following prior revisions and annual review; reflects continued administrative updates across 2023-2025 logs. (Material=false.)