See below Brief Notes regarding a COVID-19 Update for Antibody Testing
Applies to: Fully Insured Commercial Markets
COVID-19 Update: Antibody Testing
The COVID-19 (coronavirus) public health emergency has resulted in changes to the delivery and coverage of health care, including new protocols, new tests and new administrative decisions. Horizon Blue Cross Blue Shield of New Jersey (Horizon BCBSNJ) is actively monitoring and working to comply with guidance issued by federal and state authorities.
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 requirements for coverage for antibody (serological) tests 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 clarifies requirements for coverage for diagnostic testing for COVID-19 by noting that the FFCRA requires coverage when the provider makes an individualized clinical assessment to determine whether the test is medically appropriate for the individual in accordance with current accepted standards of medical practice. The CDC guidelines are generally accepted standards for medical practice that expect an individualized health assessment to determine the need for COVID-19 testing, and identify limited circumstances under which antibody testing serves a diagnostic purpose by stating that:
CDC does not currently recommend using antibody testing as the sole basis for diagnosis of acute infection, and antibody tests are not authorized by 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.
As such, Horizon BCBSNJ is implementing the following changes for the processing of antibody testing claims:
For fully insured Commercial market health plans:
• As of August 1, 2020, claims for antibody testing will require evidence for an individualized clinical assessment determining 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 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 BCBSNJ will not require proof of an individualized clinical assessment for claims for members and beneficiaries under age 21.
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 and older who self-direct for antibody testing will be denied unless evidence for an individualized health 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.
Our self-funded customers retain plan design authority and Horizon BCBSNJ will work with its self-funded customers to administer antibody testing claims per differing requirements established by their group health plans in a manner that is similarly in compliance with the FFCRA and the CARES Act.