The new federal guidance says the relevant sections of the FFCRA and the CARES Act that waive cost-sharing for diagnostic testing — copays, coinsurance and deductibles, in or out of network — also apply to antibody tests. In 2020 the CARES Act was passed through bipartisan legislation. This legislation stated that insurances cannot place any cost sharing, prior authorization, or medical management stipulation on services or products relating to Covid-19. Tests to detect antibodies in people who have previously been infected by Covid-19 must be covered free of charge under health insurance plans and Medicaid, according to the new guidance. There are rare exceptions like short-term limited durations plans. Trump Administration Announces Expanded Coverage for Essential Diagnostic Services Amid COVID-19 Public Health Emergency | CMS
In a document dated April 11, the Departments of Labor, Health and Human Services and Treasury said the Food and Drug Administration has determined that serology testing for antibodies should be considered an "in vitro diagnostic test" and treated the same as tests to detect the virus itself.
"FDA has advised the Departments that serological tests for COVID-19 meet the definition of an in vitro diagnostic product for the detection of SARS-CoV-2," the departments said, using the coronavirus' scientific name. "Therefore, plans and issuers must provide coverage for a serological test for COVID-19 that otherwise meets the requirements of" the Families First Coronavirus Response Act (FFCRA) and the CARES Act, both of which established free diagnostic testing.
The new federal guidance says the relevant sections of the FFCRA and the CARES Act that waive cost-sharing for diagnostic testing — copays, coinsurance and deductibles, in or out of network — also apply to antibody tests.
These new rules apply to Antibody test kits that have an Emergency Use Authorization by the FDA. There are two kinds of EUA approvals for these tests. There is an EUA approval for antibody tests to be used only with High Complexity labs, and there is an EUA approval for antibody tests to be used by Point of Care providers. The majority of tests are approved only for High Complexity labs and do not serve the general medical population that would like to use them. Medsential not only provides a test kit for Point of Care providers, its EUA also has approval for blood draw through finger-stick with its EUA approval. It is only one of two that allow for this. The others that are approved for Point of Care require that blood sample be acquired from a blood draw from the vein. These are important factors for providers to consider when looking to purchase rapid test kits for their office.
Although there are means for patients to receive Antibody tests at no cost through this new legislation, this does not mean that Point of Care facilities will not be reimbursed. They can bill and collect for these testing services being provided. The American Medical Association (AMA) has expedited the approval and release of CPT® coding for these tests. The new codes for use of the rapid antibody test is intended for use as the industry standard for accurate reporting and tracking of blood tests performed to specifically detect antibodies associated with the SARS-CoV-2 virus (Covid-19).
AMA President Patrice A. Harris, MD, MA stated, “Antibody testing that identifies patients that have been exposed to the novel coronavirus (SARS-CoV-2) and developed an immune response is likely to have important public health implications by providing a clearer picture of the prevalence of the disease in the U.S.”. He continued by saying, “The expedited approval of new CPT codes for COVID-19 antibody tests is an important step that enhances the reporting of innovative tools now available to advance medicine's overarching goals of reducing the COVID-19 disease burden, improving health outcomes and reducing long-term care costs.”
The Code established for the Medsential Rapid Covid-19 test kit is Code 86328. This code was established for antibody tests using a single-step method immunoassay. This testing method includes a strip with all of the critical components for the assay and would be most appropriate for a point-of-care platform.
The new Category CPT Code and long descriptor is: 86328: Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single step method (e.g., reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]).
Out of network should be reimbursed full amount billed without reduction in payment. Since the Families First Coronavirus Response Act states that commercial health insurance plans must cover Covid-19 testing without imposing any cost-sharing on enrollees and the CARES act requires that there is no surprise billing to patient and all options have to be made free to them by law if billing insurances. As a result, this provision requires health plants to pay out-of-network providers full billed charges.
Although there are many tests being marketed right now, the FDA currently has only given two Emergency use Authorizations for rapid Covid-19 antibody test kits for use with finger-stick blood draw. This is a huge advantage for the point of care providers that will be administering these tests.
The other key advantage to the Antibody test that Medsential offers is the efficacy of this test. This Covid-19 IgG/IgM test has been validated by the US Government.
· Results within 15 minutes
· Specificity: 100%
· Sensitivity: 98%
· No external reading device needed to read results
· Fingerstick whole blood (not venous blood draw) for test sample
· High sensitivity to recent exposure to SARS-CoV-2 (can pick up asymptomatic people)
Knowing that providers have a clear path for payment, and patients can feel confident that their insurances will pay for Antibody testing. There is a clear pathway for serology testing that public health experts say will be crucial for understanding how extensively the virus has spread among the various demographics and population as a whole. It could also provide valuable information at who currently have the protective antibodies in their decision to lifting lockdowns or stay-at-home orders in safely begin the process of allowing the population to return to work and school. Proper immunization followed by regular widespread antibody testing is thought to be key to achieving the goals of a safe return to business and schooling