Humana Commercial Clinical Policy

Humana Severe Acute Respiratory Syndrome Coronavirus 2 Serologic (Antibody) Testing Form

Effective Date

05/25/2023

Last Reviewed

NA

Original Document

  Reference



Description

Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, initiates a humoral immune response that produces antibodies against specific viral antigens such as the nucleocapsid (N) protein and spike (S) protein, which include specific anti-S protein antibodies that target the spike’s S1 protein subunit and receptor binding domains (RBD). Serologic tests can detect the presence of these antibodies in serum within days to weeks following acute infection. However, serologic testing should not be used to diagnose acute SARS-CoV-2 infection. Although the immune correlates of protection are not fully understood, evidence indicates that antibody development following infection likely confers some degree of immunity from subsequent infection for at least 6 months.

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Severe Acute Respiratory Syndrome Coronavirus 2 Serologic (Antibody) Testing

Effective Date: 05/25/2023

Revision Date: 05/25/2023

Review Date: 05/25/2023

Policy Number: HUM-0596-003

Page: 2 of 7

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

However, it is not known to what extent emerging viral variants may impact immunity from subsequent infection.

6Tru-Immune is an example of a surrogate viral neutralization test (sVNT) that purportedly measures the neutralizing capacity of antibodies against the SARS-CoV-2 virus. (Refer to Coverage Limitations section)

Coverage Determination

Any federal or state mandates for SARS-CoV-2 serologic (antibody) testing take precedence over this medical coverage policy.

Humana members may be eligible under the Plan for SARS-CoV-2 serologic (antibody) testing (eg, 86328, 86408, 86409, 86413, 86769, 0224U) when the following criteria are met:

  • Ordered by a physician or other licensed healthcare professional; AND
  • Test has received US Food & Drug Administration (FDA) approval or Emergency Use Authorization (EUA); AND
  • Individual has complications of COVID-19 illness, such as multisystem inflammatory syndrome (MIS) or other post-acute sequelae of COVID-19

Coverage Limitations

Humana members may NOT be eligible under the Plan for SARS-CoV-2 serologic (antibody) testing for any indications other than those listed above including, but may not be limited to, the following:

  • Assess for immunity to COVID-19 following COVID-19 vaccination; OR
  • Assess the need for COVID-19 vaccination in an unvaccinated individual; OR
  • Determine the need to quarantine after close contact with an individual who has COVID-19; OR
  • Employment (eg, pre-employment or return to work) or school purposes (eg, return to school); OR

Severe Acute Respiratory Syndrome Coronavirus 2 Serologic (Antibody) Testing

Effective Date: 05/25/2023

Revision Date: 05/25/2023

Review Date: 05/25/2023

Policy Number: HUM-0596-003

Page: 3 of 7

Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

  • Establish the presence or absence of acute SARS-CoV-2 infection; OR
  • General population or public health screening; OR
  • Newborn evaluation; OR
  • Pretransplant screening; OR
  • Surrogate viral neutralization testing (sVNT) (eg, Tru-Immune [0226U])

This is considered not medically necessary as defined in the member’s individual certificate.

Please refer to the member's individual certificate for the specific definition.

Additional information about SARS-CoV-2 may be found from the following websites:

  • BackgroundCenters for Disease Control and Prevention
  • National Library of Medicine
  • US Food & Drug Administration

Medical Alternatives

Physician consultation is advised to make an informed decision based on an individual's health needs.

Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.