Harvard Pilgrim Health Care Medical Policy

COVID-19 Antibody Test

Subject:

COVID-19 Antibody (Serological) Testing

Background:

Serology testing may detect the presence of antibodies in the blood as a result of an adaptive immune response to SARS-CoV-2. In the early days of a COVID-19 infection, the body's adaptive immune response is still building, and antibodies may not be detected. This limits the effectiveness of antibody testing and is one major reason serology testing should not be used to diagnose or exclude an acute COVID-19 infection. Serology testing can be used to identify and provide late COVID-19 diagnosis of previously infected individuals who may have developed an adaptive immune response to SARS-CoV-2. Current studies will better inform the appropriate use of antibody testing, including level of protection needed to prevent or reduce the severity of infection or re-infection and the duration for which this protection may last.

Policy and Coverage Criteria:

Harvard Pilgrim Health Care (HPHC) considers COVID-19 Antibody Testing as medically necessary when documentation confirms ALL of the following:

• Test is being ordered by the member’s treating physician or appropriately licensed care professional;
• COVID-19 antibody test is necessary to make decisions required to treat a member’s immediate medical condition (e.g. pediatric/adult multisystem inflammatory syndrome [MIS-C, MIS-A]);
• Test is being conducted by a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory;
• Requested COVID antibody serology test has received Food and Drug Administration (FDA) approval and/or FDA emergency use authorization (EUA)

Exclusions:

Harvard Pilgrim Health Care (HPHC) considers COVID-19 antibody testing as not medically necessary for all other indications. In addition, HPHC does not cover:

• Antibody testing required by a third party (e.g. employer, school, travel, court) that is not otherwise medically necessary
• Antibody testing to assess immunity to SARS-CoV-2 infection following COVID-19 vaccination, to assess the need for vaccination in an unvaccinated individual or to assess the need for re-vaccination in a vaccinated individual
• Public health and epidemiologic surveillance (e.g. vaccine efficacy, release from isolation)