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.

As requested by the AHA, the Centers for Medicare & Medicaid Services said it will continue to remain flexible in its approach to surveys if a hospital experiences a COVID-19 surge.
The Centers for Disease Control and Prevention released a COVID-19 Viral Testing Tool to help health care providers and individuals understand their COVID-19 testing options and take appropriate next steps.
Only 11% of pregnant women in the Centers for Disease Control and Prevention’s Vaccine Safety Datalink, which includes vaccine safety monitoring data from nine integrated health systems, were fully vaccinated against COVID-19 by May 8, compared with 25% of non-pregnant women, the CDC reported.
The Food and Drug Administration Friday authorized for emergency use two batches of drug substance manufactured for the Janssen (Johnson & Johnson) COVID-19 vaccine at an Emergent BioSolutions facility in Baltimore.
The Food and Drug Administration warned health care providers and the public not to use an antigen test for COVID-19 made by Innova Medical Group and distributed under several names.
The Centers for Disease Control and Prevention is asking jurisdictions to distribute portions of their COVID-19 vaccine allocations to enable administration at hospitals, emergency departments and urgent care facilities following patients’ discharge.
Johnson & Johnson said the Food and Drug Administration agreed to extend the expiration date for its COVID-19 vaccine by six weeks.
Health care providers participating in the Centers for Disease Control and Prevention’s COVID-19 Vaccination Program must administer the vaccines at no cost to recipients, the Department of Health and Human Services reminded providers and health plans in a letter.
The Food and Drug Administration is warning health care providers and the public not to use two COVID-19 antigen and antibody tests, due to high risk of false results.