FAQ: Must plans cover COVID-19 antibody tests without cost sharing?

July 21, 2020

Yes, plans must cover COVID-19 antibody tests without cost-sharing. As background, the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief and Economic Security (CARES) Act require both insured and self-funded plans to cover COVID-19 testing without cost sharing. Specifically, the FFCRA provides that the required testing includes “in vitro diagnostic products for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19.”

Back in April, HHS, the DOL and the Treasury provided a set of FAQs on the obligations to cover COVID-19 testing under the FFCRA and CARES Act. (We discussed the FAQs in our April 14, 2020, edition of Compliance Corner.) One of the questions explicitly indicates that “in vitro diagnostic products” includes serological tests used to detect antibodies for the virus that causes COVID-19. Q/A 4 reads as follows:

Q4. Do “in vitro diagnostic tests” described in section 6001(a)(1) of the FFCRA, as amended by section 3201 of the CARES Act, include serological tests for COVID-19?
 
Yes. Serological tests for COVID-19 are used to detect antibodies against the SARS-CoV-2 virus, and are intended for use in the diagnosis of the disease or condition of having current or past infection with SARS-CoV-2, the virus which causes COVID-19. The Food and Drug Administration (FDA) currently believes such tests should not be used as the sole basis for diagnosis. 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 or the diagnosis of COVID-19. Therefore, plans and issuers must provide coverage for a serological test for COVID-19 that otherwise meets the requirements of section 6001(a)(1) of the FFCRA, as amended by section 3201 of the CARES Act.

So although the guidance states that serological tests should not be the sole basis for COVID-19 diagnosis at this time, the FFCRA and CARES Act require plans and insurers to cover these tests (among other services) without cost-sharing when medically appropriate for the individual (as determined by the individual’s attending healthcare provider in accordance with accepted standards of current medical practice).