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.

The Centers for Medicare & Medicaid Services Oct. 9 announced a crackdown on labs that are testing for COVID-19 without proper Clinical Laboratory Improvement Amendments certification.
Among 767 hotspot counties for COVID-19 in June and July, early increases in the rate of positive test results for Americans under age 25 were followed by several weeks of rising positivity rates in older age groups, the Centers for Disease Control and Prevention reported.
The Food and Drug Administration recommended that health care providers provide written or video step-by-step instructions, in addition to verbal instructions, to patients who are self-collecting anterior nares (nasal) samples for COVID-19 testing in a health care setting.
The Food and Drug Administration warned Battelle Memorial Institute that its respirator decontamination system does not comply with the requirement in its emergency use authorization to establish internal systems that provide for timely and effective identification, communication and evaluation of鈥
The Food and Drug Administration released guidance and a briefing document outlining the key data needed to support an emergency use authorization for a COVID-19 vaccine candidate and further explaining the EUA process.
The Centers for Medicare & Medicaid Services (CMS) today released guidance on how it will implement an Aug. 25 interim final rule that makes collecting and reporting COVID-19 data a condition of participation (CoP) for hospitals that participate in Medicare.
Please contact your Republican senators today and ask them sign on to a 鈥淒ear Colleague鈥 letter to the Department of Health and Human Services (HHS) expressing concerns that a Sept. 19 change in HHS鈥 COVID-19 Provider Relief Fund (PRF) reporting requirements will create uncertainty and financial鈥
Please contact your Republican senators today and ask them sign on to a 鈥淒ear Colleague鈥 letter to the Department of Health and Human Services (HHS) expressing concerns that a Sept. 19 change in HHS鈥 COVID-19 Provider Relief Fund (PRF) reporting requirements will create uncertainty and financial鈥
The Centers for Disease Control and Prevention updated its guidance on how COVID-19 spreads to acknowledge published reports showing 鈥渓imited, uncommon鈥 circumstances where people with COVID-19 infected others who were more than 6 feet away.
The Centers for Disease Control and Prevention released guidance to help health care and public health providers prevent HIV outbreaks among people who inject drugs, including considerations for delivering services during the COVID-19 pandemic.