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 reminded clinical laboratory staff and health care providers to follow recommended steps to prevent false positive results from antigen tests for the COVID-19 virus, citing reports of false positives in nursing homes and other settings.
The Centers for Disease Control and Prevention would like to partner with one or more organizations to enable centralized reporting from COVID-19 testing entities to public health departments, the agency said this week in a request for information.
The Food and Drug Administration, Customs and Border Protection, and Immigration and Customs Enforcement Oct. 30 announced a memorandum of understanding to maximize inspection and detection capabilities in order to prevent harmful products from entering the U.S. through international mail…
AHA letter urging the Centers for Medicare & Medicaid Services to immediately withdraw the new condition of participation that threatens to expel hospitals from the Medicare program if they fail to comply with “frequently changing and confusing” COVID-19 data collection efforts.
The Department of Health and Human Services issued an important clarification to its Oct. 22 reporting requirements for providers that received Provider Relief Fund payments.
The Food and Drug Administration updated its guidance on enforcement policy for non-invasive remote monitoring devices that support patient monitoring during the COVID-19 public health emergency.
The Centers for Medicare & Medicaid Services announced an interim final rule establishing additional Medicare hospital payment to support Medicare beneficiaries’ access to COVID-19 vaccines and new treatments when they become available.
In partnership with the AHA’s Center for Health Innovation and other national health care organizations, the Centers for Disease Control and Prevention launched Project Firstline, a national training collaborative to help every health care worker understand and adhere to recommended infection…
The Food and Drug Administration released an updated template for developers requesting emergency use authorization for antigen tests for the COVID-19 virus.