COVID-19: CDC, FDA and CMS Guidance

This page includes AHA Today stories and other AHA content on coronavirus COVID-19 guidance from the CDC, FDA, and CMS.

Children and adolescents in Mississippi who tested positive for the SARS-CoV-2 virus were more likely to report close contact with someone with confirmed COVID-19 and less likely to report consistent mask use at school, according to a study released by the Centers for Disease Control and Prevention…
The Food and Drug Administration issued an emergency use authorization for the first over-the-counter fully at-home diagnostic test for COVID-19. The antigen test for persons age 2 and older can detect the SARS-CoV-2 virus in a nasal swab sample in about 20 minutes.
Ahead of a Dec. 17 meeting of its Vaccines and Related Biological Products Advisory Committee, the Food and Drug Administration released a briefing document confirming Moderna’s data on the safety and efficacy of the mRNA-1273 COVID-19 vaccine candidate.
The Centers for Medicare & Medicaid Services recently posted information on how hospitals and other health care providers should bill Medicare for administering COVID-19 vaccines.
A recent Centers for Disease Control and Prevention analysis based on 14 states found that the cumulative incidence of lab-confirmed COVID-19 cases among American Indian and Alaska Native persons was 3.5 times higher than among white persons, underscoring the need to develop collaborative…
The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee Dec. 10 recommended the approval of Pfizer, Inc.’s BNT162b2 mRNA COVID-19 vaccine. The panel voted 17-4, with one abstention, that FDA issue an emergency use authorization.
The Food and Drug Administration authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by adults without a prescription.
The Centers for Medicare & Medicaid Services updated its FAQs regarding coverage, billing and payment for monoclonal antibody therapies used to treat COVID-19.
The Department of Health and Human Services (HHS) yesterday updated its guidance to hospitals on the reporting of COVID-19-related data. The guidance includes two key changes stemming from the Centers for Medicare & Medicaid Services’ (CMS) Dec.
The AHA Friday, Dec. 11 at 3 p.m. ET will host a call with officials from the Centers for Disease Control and Prevention on COVID-19 vaccine distributions.