Novel Coronavirus (COVID-19) News

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 adverse events, and asked the device maker to submit a correction plan within 14 days.

The American Medical Association released for immediate use Current Procedural Terminology codes for reporting on medical claims two laboratory tests (87636 and 87637) that simultaneously detect the COVID-19 virus, influenza A/B and respiratory syncytial virus.

The National Institutes of Health’s Rapid Acceleration of Diagnostics initiative awarded $98.4 million in contracts to scale up and manufacture new COVID-19 testing technologies.

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 Disease Control and Prevention updated its guidance on how COVID-19 spreads to acknowledge published reports showing “limited, uncommon” circumstances where people with COVID-19 infected others who were more than 6 feet away.

COVID-19 cases in Arizona fell 75% between July 13 and Aug. 7 after sustained community mitigation measures that promoted social distancing, required or encouraged mask wearing, limited large gatherings, and paused business operations where mask use and social distancing were difficult to maintain, the Centers for Disease Control and Prevention reported.

The Centers for Medicare & Medicaid Services released guidance on how it will implement its August interim final rule that makes collecting and reporting COVID-19 data a condition of participation for hospitals that participate in Medicare.

The Food and Drug Administration on Oct. 7 will host the first in a series of virtual Town Halls to answer technical questions about test development and validation for SARS-CoV-2, the virus that causes COVID-19.

To continue amplifying the important message to protect against both the flu and COVID-19, AHA’s Wear A Mask and United Against the Flu campaigns have released new resources, including sample social media messages geared toward different age groups and graphics and videos on the importance of masking up and getting a flu shot.

President Trump issued an executive order creating a cabinet-level working group to develop a federal plan to better coordinate services to prevent suicide and mental and behavioral health conditions in vulnerable populations during the COVID-19 pandemic.

The Department of Health and Human Services opened the application process for $20 billion in funds from the Public Health and Social Services Emergency Fund.

The ongoing COVID-19 pandemic has highlighted a critical need for care that is customized, patient-centered, cost-effective and, most of all, successful. Team-based care checks all of these boxes and more.

The House approved an updated version of the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act that includes $2.2 trillion in additional COVID-19 relief funds.

The National Academies of Science, Engineering and Medicine released A Framework for Equitable Allocation of Vaccine for the Novel Coronavirus to assist and guide the federal government and decision-making bodies, including the Advisory Committee on Immunization Practices, as well as state, tribal, local and territorial authorities in their COVID-19 vaccine allocation planning.

Department of Health and Human Services Secretary Alex Azar announced the renewal of the COVID-19 national public health emergency declaration.

While hospitals and health systems — and their brave front-line caregivers — continue to battle the greatest public health challenge of our lifetimes, the Department of Health and Human Services recently made a change to its COVID-19 Provider Relief Fund (PRF) reporting requirements that could jeopardize access to care for patients and communities.

The Department of Health and Human Services Assistant Secretary for Preparedness and Response has released a recording of its Sept. 24 webinar on strategies to optimize personal protective equipment and supplies during the COVID-19 public health emergency.

A vast majority of nurse leaders (86%) feel prepared for a future COVID-19 surge, according to more than 1,800 nurse leaders the AHA’s American Organization for Nursing Leadership surveyed in July about pandemic preparedness and other key issues.

The Food and Drug Administration posted updated comparative performance data for molecular tests to diagnose the COVID-19 virus.

Beginning October 1, American hospitals can purchase Veklury (remdesivir) directly from the drug’s distributor, the Department of Health and Human Services announced today.