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COVID-19: FDA Updates Test Review Policy, HHS Covers Bebtelovimab for Uninsured

The U.S. Food and Drug Administration (FDA) updated its COVID-19 test policy Sept. 27, urging COVID-19 test developers to shift their focus to traditional premarket review pathways for tests already authorized for emergency use and new tests of the same types as those already available under emergency use authorization (EUA).

Additionally, the updated policy describes FDA’s intent to review only a small subset of new EUA requests for diagnostic tests.

The administration says the update serves to better meet public health needs at the current stage of the COVID-19 public health emergency, citing the status of manufacturing capacity and consumer access.

HHS to Cover Some Bebtelovimab Costs

The U.S. Department of Health and Human Services (HHS) announced on Sept. 23 that it will cover the costs of 60,000 doses of bebtelovimab, a COVID-19 monoclonal antibody treatment, in a new effort to help uninsured and underinsured Americans access the drug.

Through the agency’s initiative, health care providers who use a commercially procured dose of bebtelovimab to treat an uninsured or underinsured patient may be eligible to have the dose replaced for free by HHS. HHS will let health care providers determine a patients’ uninsured or underserved status.

Bebtelovimab was first made commercially available for purchase on Aug. 17.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at or 202.585.0127 with questions.


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