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.

Drug overdose deaths increased 18% over the 12-month period that ended in May to a record 81,230, according to a new Centers for Disease Control and Prevention advisory.
The Food and Drug Administration authorized a prescription BinaxNOW COVID-19 test for use by patients at home, in partnership with a telehealth service that will take users through the sample collection process and assist in reading and understanding the results.
The Food and Drug Administration Center for Biologics Evaluation and Research Prevention has addressed new information that shipped vials of Pfizer’s BND162b2 mRNA COVID-19 vaccine contain extra doses, indicating that it is acceptable to use every full dose obtainable from each product vial.
The Centers for Medicare & Medicaid Services (CMS) today announced that it is extending the quarter 3 (Q3) 2020 data submission deadlines for several of its quality reporting and value programs for hospitals, post-acute care and other providers. CMS indicates the extension is intended “to help…
The Centers for Disease Control and Prevention will award states and territories another $227 million in funding from the Coronavirus Aid, Relief, and Economic Security Act and Paycheck Protection Program and Health Care Enhancement Act for COVID-19 vaccine preparedness and complementary activities…
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…