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 Food and Drug Administration issued guidance for the development of a SARS-CoV-2 vaccine, outlining key considerations to satisfy requirements for chemistry, manufacturing and control, nonclinical and clinical data.
The Food and Drug Administration authorized the emergency use of two COVID-19 molecular diagnostic tests. The tests from Inform Diagnostics Inc. and Diagnostic Solutions Laboratory LLC detect in respiratory specimens nucleic acid from SARS-CoV-2, the virus that causes COVID-19.
SARS-CoV-2 infections may be 10 times higher than reported cases, according to new data from a Centers for Disease Control and Prevention partnership with commercial laboratories to test de-identified clinical blood specimens for antibodies in Connecticut, South Florida, the New York City area,…
The Food and Drug Administration added the AustinP51 emergency-use system to its list of ventilator authorized for emergency use in health care settings to treat adults during the COVID-19 pandemic.
The Centers for Disease Control and Prevention has updated and expanded its list of people at risk of severe COVID-19 illness, the agency said.
AHA today urged the Centers for Medicare & Medicaid Services to temporarily extend certain waivers and make others permanent beyond the COVID-19 public health emergency to allow hospitals to provide better and more cost effective care to their patients and communities.
Clinicians participating in the Quality Payment Program Merit-based Incentive Payment System in 2020 whose practice was significantly impacted by the COVID-19 public health emergency may apply for an exception to reweight the MIPS performance categories, the Centers for Medicare & Medicaid…
The Centers for Medicare & Medicaid Services recently confirmed that Medicare contractors will not calculate an average length of stay for long-term care hospitals for cost reporting periods that include the COVID-19 public health emergency, which took effect March 1.
The Food and Drug Administration has partnered with the Critical Path Institute and National Center for Advancing Translational Sciences to launch the CURE Drug Repurposing Collaboratory, a forum for exchanging clinical practice data to inform potential new uses for existing drugs to treat unmet…
Hospitalization rates for COVID-19 were nearly four times higher for black, and two times higher for Hispanic, Medicare beneficiaries than for white Medicare beneficiaries, according to data on COVID-19 cases and hospitalizations released by the Centers for Medicare & Medicaid Services.