Zika virus risk assessment and testing
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Defines coverage criteria for laboratory testing (NAAT, IgM, PRNT) and specimen types related to Zika virus exposure, with emphasis on pregnant persons, fetuses, and infants; applies to benefit determinations for covered members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Zika Virus Testing
Covered Indications
Covered when ANY of the following are met
From policy items 1a and 1b (III.1) and related CDC guidance
From policy items 2a and Reimbursement Policy item 3 (III.2, Reimbursement Policy 3)
Policy item 2b and Updated Testing Guidance (chunks 18-19)
Policy item 2c (III.2c) and CDC/updated guidance (chunk 18)
Reimbursement Policy item 4 and CDC guidance on interpretation limitations (chunk 4, chunk 18)
Not Medically Necessary / Not Covered
Not covered when ANY of the following are present
Reimbursement Policy item 5 (chunk 4)
Reimbursement Policy item 6 (chunk 4)
Reimbursement Policy item 7 (chunk 4)
Covered Indications per CDC/ACOG
Covered when testing meets CDC/ACOG-guided clinical indications and specimen timing:
CDC/Updated Testing Guidance (chunks 18-19)
CDC guidance cited in reimbursement policy (chunks 18-19)
CDC recommendations (chunk 19 and CDC diagnostic guidelines chunk 21)
Policy items and CDC infant guidance (chunks 3 and 21)
CDC/ACOG context and consideration of declining prevalence and testing limitations (chunk 21)
Serologic IgM testing has important limitations for diagnosing Zika infection and is not routinely recommended for screening asymptomatic pregnant women. IgM antibodies can persist for months after infection and frequently cross-react with other flaviviruses, making interpretation difficult; this can prevent determining whether infection occurred before or during the current pregnancy. Policy language therefore restricts routine use of IgM in asymptomatic pregnant populations and recommends selective use tied to clinical indications (for example, maternal serum IgM when a fetus has ultrasound findings consistent with congenital infection).
Asymptomatic individuals without symptoms suggestive of Zika infection — including asymptomatic pregnant women who only traveled to Zika-affected areas and asymptomatic returned travelers who are trying to conceive — are generally not candidates for routine Zika testing per referenced public health guidance. The policy aligns with PHE and related guidance that testing should be reserved for persons with symptoms or specific clinical indications rather than travel alone.
Within the excerpt provided there are no additional explicit exclusions beyond the stated not-covered items (preconception screening, non-pregnant late presenters, and tests/samples not listed). The policy enumerates tests and specimen types that do not meet coverage criteria but does not list further named exclusions in this section.
The policy explicitly states that preconception screening is not covered: Zika urine and serum NAAT testing and Zika serum IgM testing for preconception screening DOES NOT MEET COVERAGE CRITERIA. Similarly, in non-pregnant individuals presenting ≥ 14 days after symptom onset, urine and serum NAAT and serum IgM testing do not meet coverage criteria.
External advisory bodies, including CATMAT, advise against routine testing of asymptomatic pregnant women because of the low prevalence of infection and the poor positive predictive value of serologic screening; a positive serologic result in low-prevalence settings is likely to be a false positive and carry significant adverse consequences.
In the provided excerpt there is no explicit statement phrased as 'not medically necessary' beyond the enumerated items that 'DOES NOT MEET COVERAGE CRITERIA.' The policy uses the formal language of coverage criteria and non-coverage rather than additional separate 'not medically necessary' declarations in this section.
Applicable Procedure and Billing Codes
| No codes listed |
Provider Actions, Billing & Documentation Requirements
Claim documentation
When submitting claims for Zika testing, include supporting clinical documentation that demonstrates the indication for testing (e.g., pregnancy status, symptom onset date, travel or exposure history, fetal ultrasound findings, infant clinical findings, specimen source and collection timing). Failure to provide adequate documentation may lead to denials or requests for additional information.
- Document specimen source (serum, urine, CSF, amniotic fluid, placental/fetal tissue) and timing relative to symptom onset or delivery.
- Include maternal/infant clinical findings, pregnancy status, prenatal ultrasound results, and exposure/travel history.
Government policy precedence
When government coverage policies (e.g., Medicare Local Coverage Determinations or National Coverage Determinations) conflict with this payer policy, the applicable government policy takes precedence. Verify and follow the most current Medicare or state Medicaid coverage rules for members subject to those programs.
- LCDs and NCDs override payer policy when applicable.
- Check CMS and state Medicaid websites for the latest determinations before finalizing coverage decisions.
Testing sequence for symptomatic pregnant women
For symptomatic pregnant women with recent travel to or sexual contact linked to areas with Zika risk, prioritize molecular testing: perform dengue and Zika NAAT on a serum specimen and Zika NAAT on a urine specimen; perform dengue IgM testing (not Zika IgM). If Zika NAAT is positive on a single specimen, repeat the NAAT on newly extracted RNA from the same specimen to rule out false-positive results. If dengue NAAT or dengue IgM is positive, no further testing is indicated.
- Collect specimens as soon as possible after symptom onset and up to 12 weeks post-onset.
- Perform dengue and Zika NAAT on serum, Zika NAAT on urine, and dengue IgM testing.
- Do NOT rely on Zika IgM for symptomatic pregnant women due to persistence and cross-reactivity.
Repeat NAAT recommendation
If a Zika NAAT is positive on a single specimen, repeat the NAAT on newly extracted RNA from the same specimen to rule out false-positive NAAT results before reporting a confirmed positive.
- Repeat NAAT on newly extracted RNA from the same specimen when an initial single-specimen NAAT is positive.
Definitions and Test Methodology
Background on Zika Virus
Zika virus is a mosquito-borne flavivirus that typically causes mild illness in most infected persons but carries a substantial risk of congenital abnormalities when infection occurs during pregnancy. Laboratory diagnosis relies on NAAT/rRT-PCR for viral RNA in serum, urine, CSF or tissues and on serologic IgM testing with confirmatory PRNT when indicated; however, RNA is transient in body fluids and IgM can persist or cross-react with other flaviviruses, limiting sensitivity and specificity. Because of these diagnostic limitations and the potentially severe consequences for the fetus, the policy focuses coverage on pregnant persons, fetuses, and infants with clinical indications (for example, fetal ultrasound findings, symptomatic pregnant individuals with exposure, or infants with congenital findings) rather than routine screening of asymptomatic persons.
Revision History
Policy became effective on 2023-07-01 (Adopted Avalon policy recommendation).
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