New guidance issued jointly by the Department of Labor (DOL), the Department of Health and Human Services (HHS), and the Department of the Treasury (Treasury, and collectively, the Departments) on June 23, 2020, as well as guidance issued by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) in July, impacts how antibody (serological) tests are covered under the Families First Coronavirus Response Act (the FFCRA) as amended by the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act).

The Departments’ guidance incorporates guidelines from the CDC for diagnostic testing for COVID-19. The CDC expects individualized health assessments to determine the need for COVID-19 testing, and identifies limited circumstances under which antibody testing serves a diagnostic purpose by stating that the:

• CDC does not currently recommend using antibody testing as the sole basis for diagnosis of acute infection, and antibody tests are not authorized by the FDA for such diagnostic purposes. In certain situations, serologic assays may be used to support clinical assessment of persons who present late in their illnesses when used in conjunction with viral detection tests. In addition, if a person is suspected to have post-infectious syndrome (e.g., Multisystem Inflammatory Syndrome in Children) caused by SARS-CoV-2 infection, serologic assays may be used.

The Departments also clarified that health plans will not be required to cover public health and occupational testing because they are not diagnostic, and therefore, not the medically appropriate care that is covered under member health plans.

For our Medicaid members, Horizon NJ Health is implementing the following changes for the processing of antibody testing claims:

• As of August 1, 2020, claims for antibody testing will require evidence for an individualized clinical assessment to determine whether the test is medically appropriate for the individual in accordance with currently accepted standards of medical practice having been performed by the ordering clinician, acting within their scope of their licensure, to be eligible for reimbursement.
  
  However, because CDC guidelines indicate that antibody testing may be appropriate with respect to Multisystem Inflammatory Syndrome in Children, associated with COVID-19, for those patients less than 21 years of age, Horizon NJ Health will not require proof of an individualized clinical assessment for claims for members and beneficiaries.
  
  These claims will be reimbursed without member cost sharing until at least 90 days after the end of the public health emergency and State of Emergency declared by Governor Murphy in Executive Order 103 of 2020.
  
  Claims for members age 21 years and older who self-direct for antibody testing will be denied unless proof of an individualized clinical assessment is provided and shows that the test was ordered for diagnostic purposes.



• Antibody testing claims received before August 1, 2020 will be paid without member cost sharing and without requiring proof of an individualized health assessment, as testing was done before the federal government released guidance for these claims.