At-home SARS-CoV-2 tests may be a promising avenue to get more people tested in a timely manner and also reduce the risk of exposure in health care settings. The interactive table below includes vendors selling at-home SARS-CoV-2 diagnostic tests that have received emergency use authorization (EUA) from the Food and Drug Administration (FDA). At this time, the FDA has not authorized any SARS-CoV-2 tests that can be completely used and processed at home. The tests that have received EUAs allow for home collection of samples that are then sent back to a laboratory for processing and test reporting. Some companies require a face-to-face telehealth visit with a medical professional who guides the consumer through the sample collection. The FDA has also clarified that any test intended for at-home use, with or without the use of telemedicine, requires an EUA. For more information on at-home testing see our post At-Home SARS-CoV-2 Diagnostic Tests Could be a Breakthrough, But What Are the Limitations?
The Families First Coronavirus Response Act (P.L. 116-127), and the CARES Act require private insurance, Medicare, Medicare Advantage plans, Medicaid, and the Children’s Health Insurance Program to cover (without cost-sharing or other cost-containment measures) a SARS-CoV-2 test if the test has received an EUA from the FDA or if it is FDA-approved. The CARES Act also requires private plans to fully cover out-of-network tests at the price posted on the testing company’s public website, but does not prohibit out-of-network providers from billing patients directly for the test and leaving the patient to submit the bill to the health plan for reimbursement.
KFF will continue to add new vendors who receive EUAs from the FDA for at-home diagnostics tests and sample collection kits.