CMS clarifies when health plans must cover COVID-19 tests; FDA authorizes new at-home test

Mar 01, 2021 - 03:00 PM
COVID19 Testing Web Sized

The Centers for Medicare & Medicaid Services Friday released guidance clarifying federal requirements for health plans to cover certain items and services related to diagnostic testing for COVID-19 without cost-sharing, prior authorization or other medical management requirements.

The guidance also includes information on federal reimbursement for COVID-19-related services provided to the uninsured.

In other news, the Food and Drug Administration today issued an emergency use authorization for the Quidel QuickVue At-Home COVID-19 Test, a prescription antigen test that allows individuals to collect and test a sample at home when their health care provider suspects they have COVID-19 within six days of symptom onset.

The EUA requires Quidel to develop a mobile phone application or website to facilitate results reporting by the user and health care provider. A research team funded by the National Institutes of Health has launched a study to assess the app’s performance and usability.

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