Concert Infectious Disease: Vector-borne and Tropical Diseases Testing Form

CG.CP.MP.06 Concert Infectious Disease: Vector-borne and Tropical Diseases Testing  
2025.1  
Date of Last Revision: 11/2024  

CENTENE Corporation  

Coding Implications  
Revision log  

# CONCERT INFECTIOUS DISEASE:  
# VECTOR-BORNE AND TROPICAL  
# DISEASES TESTING  

See Important Reminder at the end of this policy for important regulatory and legal information.  

## OVERVIEW  

Vector-borne diseases are caused by bacteria, viruses, and parasites that are transmitted by other living organisms to humans. Mosquitos, fleas, and ticks are examples of vectors. Mosquitos can transmit diseases such as malaria or Zika virus infection, and ticks can transmit Lyme disease and ehrlichiosis, among others. Risk factors for vector-borne diseases include geographical area/climate, seasonality, quality of water supply and sanitation, and social factors influencing contact with vectors, such as travel and trade. Many vector-borne illnesses are most common in tropical or subtropical environments. This policy outlines coverage criteria for Lyme disease and Zika virus testing via serologic and molecular methods.  

This policy is intended for use in the outpatient setting.  

## POLICY REFERENCE TABLE  

| Criteria Sections | Example Tests (Labs) | Ref |
|-------------------|---------------------|-----|
| Lyme Disease (Borrelia burgdorferi) Serum Antibody Tests | Lyme Disease Ab with Reflex to Blot (IgG, IgM) (Quest Diagnostics) | 1 |
| Lyme Disease (Borrelia burgdorferi) Nucleic Acid/PCR Tests | Lyme Disease, Borrelia burgdorferi, Real-time PCR (LabCorps) |  |
| Other Non-covered Lyme Disease Tests | Lymphocyte Antigen Proliferation (ARUP Laboratories) |  |
|  | Lyme Borrelia Nanotrap Urine Antigen Test (Galaxy Diagnostics) |  |
|  | Lyme ImmunoBlots IgG (IGeneX Inc.) |  |
|  | Lyme ImmunoBlot IgM (IGeneX Inc.) |  |
| Zika Virus Nucleic Acid/PCR Tests | Zika Virus, PCR, Molecular Detection, Serum (Mayo Clinic Laboratories) | 2, 3 |
| Zika Virus Antibody Tests | Zika Virus, IgM Antibody Capture ELISA, Serum (Mayo Clinic Laboratories) |  |


## CRITERIA  

It is the policy of health plans affiliated with Centene Corporation® that the specific tests noted below are medically necessary when meeting the related criteria:  

## LYME DISEASE TESTS  

  

  

### Other Non-covered Lyme Disease Tests  

I. Current evidence does not support the use of these specific Lyme disease tests:  
    A. Lymphocyte transformation tests  
    B. Lyme Borrelia Nanotrap Urine Antigen Test  
    C. Lyme ImmunoBlots IgG  
    D. Lyme ImmunoBlot IgM  

## ZIKA TESTS  

  

  

*Personal symptoms of Zika virus infection such as fever and conjunctivitis.  

## NOTES AND DEFINITIONS  

1. Lyme neuroborreliosis is characterized by cranial or peripheral nerve involvement (facial palsy, radiculoneuropathy), or central nervous system involvement (meningitis/encephalitis).  
2. Lyme arthritis is characterized by obvious swelling of one or more joints and joint pain with movement.  
3. Congenital Zika virus infection is a syndrome characterized by a combination of severe microcephaly, sometimes with malformation of the craniofacial bones/skull; decreased brain tissue with a specific pattern of brain damage, including subcortical calcifications; damage to the back of the eye, including macular scarring and focal retinal pigmentary mottling; congenital contractures, such as clubfoot or arthrogryposis; and hypertonia/stiff or rigid posture with restricted movement.  

## BACKGROUND AND RATIONALE  

### Lyme Disease (Borrelia burgdorferi) Serum Antibody Tests  

Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR)  

In the 2020 Guidelines for the Prevention, Diagnosis and Treatment of Lyme Disease, the joint societies make the following recommendations regarding diagnostic testing for Lyme disease. (p. e2-e5)  

- Recommend against testing in:  
    ◦ Asymptomatic patients for exposure to B. burgdorferi following an Ixodes spp. tick bite (strong recommendation, moderate-quality evidence),  
    ◦ Patients with potential tick exposure in a Lyme disease endemic area who have 1 or more skin lesions compatible with erythema migrans; we recommend clinical  

diagnosis rather than laboratory testing (strong recommendation, moderate quality evidence).  
    ◦ [X.2] Patients with typical amyotrophic lateral sclerosis, relapsing-remitting multiple sclerosis, Parkinson’s disease, dementia or cognitive decline, or new-onset seizures (strong recommendation, low-quality evidence).  
    ◦ Patients presenting with nonspecific magnetic resonance imaging (MRI) white matter abnormalities confined to the brain in the absence of a history of clinical or epidemiologic support for the diagnosis of Lyme disease (weak recommendation, low-quality evidence).  
    ◦ Patients with psychiatric illness (strong recommendation, low-quality evidence)  
    ◦ Children presenting with developmental, behavioral or psychiatric disorders (weak recommendation, low-quality evidence).  
    ◦ Patients with neurological syndromes other than those listed in recommendation X.1 or X.2, in the absence of a history of other clinical or epidemiologic support for the diagnosis of Lyme disease (strong recommendation, low-quality evidence).  
    ◦ Patients with chronic cardiomyopathy of unknown cause (weak recommendation, low-quality evidence).  
- Recommend serum antibody testing in:  
    ◦ Patients with 1 or more skin lesions suggestive of, but atypical for erythema migrans (weak recommendation, low-quality evidence).  
    ◦ Patients with possible Lyme neuroborreliosis involving either the peripheral nervous system (PNS) or central nervous system (CNS).  
        ■ [X.1] Patients presenting with 1 or more of the following acute disorders: meningitis, painful radiculoneuritis, mononeuropathy multiplex including confluent mononeuropathy multiplex, acute cranial neuropathies (particularly VII, VIII, less commonly III, V, VI and others), or in patients with evidence of spinal cord (or rarely brain) inflammation, the former particularly in association with painful radiculitis involving related spinal cord segments, and with epidemiologically plausible exposure to ticks infected with B burgdorferi (strong recommendation, moderate-quality evidence).  
    ◦ Patients with possible Lyme arthritis (strong recommendation, moderate quality of evidence).  
    ◦ Patients with acute myocarditis/pericarditis of unknown cause in an appropriate epidemiologic setting, we recommend testing for Lyme disease (strong recommendation, low quality evidence).  

### Lyme Disease (Borrelia burgdorferi) Nucleic Acid/PCR Tests  

Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR)  

In the 2020 Guidelines for the Prevention, Diagnosis and Treatment of Lyme Disease, the joint societies recommend serum antibody testing over PCR or culture methods in most clinical scenarios (V.1, IX.1, p. e2-e5).  

“…numerous nonserologic methods have been proposed or developed, including nucleic acid amplification tests, culture methods, and antigen detection assays, among others. At present, few nonserologic testing methods are useful or practical for clinical diagnosis, and those that are—primarily nucleic acid amplification tests—are mostly  

beneficial as adjunctive tests in select clinical scenarios when 2-tiered serologic testing is positive.”  

The joint societies only explicitly recommend PCR testing for Lyme disease in one clinical scenario:  

“In seropositive patients for whom the diagnosis of Lyme arthritis is being considered but treatment decisions require more definitive information, we recommend PCR applied to synovial fluid or tissue rather than Borrelia culture of those samples (strong recommendation, moderate-quality evidence).” (p. e5)  

### Other Non-covered Lyme Disease Tests  

Infectious Diseases Society of America (IDSA), American Academy of Neurology (AAN), and American College of Rheumatology (ACR)  

“Some commercially available laboratory testing methods, including nonstandard serology interpretation, urine antigen, DNA testing, the use of a lymphocyte transformation test, or quantitative CD57 lymphocyte assay should be avoided for clinical use due to lack of systematic, independent, reproducible validation studies.” (p. e10)  

### Zika Virus Nucleic Acid/PCR Tests  

Centers for Disease Control and Prevention (CDC)  

- For asymptomatic pregnant persons living in or with recent travel to the U.S. and its territories, routine Zika virus testing is NOT currently recommended.  
- For asymptomatic pregnant individuals with a female reproductive system with recent travel to an area with risk of Zika outside the U.S. and its territories, Zika virus testing of any kind is NOT routinely recommended; if testing is performed, it can be performed via NAAT up to 12 weeks after travel.  
- Healthcare providers should test pregnant individuals with a female reproductive system with symptoms of Zika (e.g., fever, rash, headache, arthralgia, conjunctivitis, and muscle pain) if they may have been exposed to Zika through sex without a condom with a person who lives in or traveled to an area with risk of Zika.  
- Zika virus NAAT should be performed on maternal serum and urine for pregnant individuals with a female reproductive system who have a fetus with prenatal ultrasound findings consistent with congenital Zika virus infection who live in or traveled to areas with a risk of Zika during pregnancy.  
- Zika virus testing should NOT be performed as part of preconception screening.  
- Zika testing is NOT currently recommended for symptomatic non-pregnant patients based on the current epidemiology of these viruses.  

“Laboratory testing for congenital Zika virus infection is recommended for infants born to mothers with laboratory evidence of Zika virus infection during pregnancy, and for 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.”  

### Zika Virus Antibody Tests  

Centers for Disease Control and Prevention (CDC)  

- Zika virus serologic testing is NOT recommended for symptomatic or asymptomatic pregnant individuals with a female reproductive system.  

- Zika virus IgM testing should be performed on maternal serum for pregnant individuals with a female reproductive system who have a fetus with prenatal ultrasound findings consistent with congenital Zika virus infection 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.  
- Zika virus testing should NOT be performed as part of preconception screening.  
- Zika testing is NOT currently recommended for symptomatic non-pregnant patients based on the current epidemiology of these viruses.  

“Laboratory testing for congenital Zika virus infection is recommended for infants born to mothers with laboratory evidence of Zika virus infection during pregnancy, and for 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.”  

## Coding Implications