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.

About 60% of participants in a study of young adults infected with COVID-19 on a U.S. aircraft carrier had reactive antibodies to the virus, 59% of whom also had neutralizing antibodies at the time of specimen collection, according to a report released by the Centers for Disease Control and…
AHA submitted comment to the Centers for Medicare & Medicaid Services on the agency’s proposed skilled nursing facility prospective payment system for fiscal year 2021, urging CMS to support additional funds to offset the cost of critically important COVID-19 testing.
The Food and Drug Administration does not intend to object to a manufacturer or authorized distributor delivering prescription drug samples directly to licensed practitioners or their patients at their homes during the COVID-19 emergency when requested by the practitioner in accordance with…
The Centers for Medicare & Medicaid Services released a guide for patients considering in-person, non-emergency treatment as the country continues to reopen and COVID-19 cases decline.
FDA released new guidance that expands for the duration of the COVID-19 emergency the availability and capability of non-invasive monitoring devices.
CMS released guidance for non-federal governmental plans implementing the Families First Coronavirus Response Act requirement to cover COVID-19 diagnostic testing and certain related items and services without cost-sharing, prior authorization or other medical management restrictions during the…
The Food and Drug Administration reissued emergency use authorizations that revise policy on the types of respirators that can be decontaminated for reuse.
This document outlines changes made by the Food and Drug Administration to its policy governing the decontamination and reuse of certain respirators during the COVID-19 public health emergency.
The Food and Drug Administration released COVID-19 performance data for four more antibody test kits. The results come from the first collaboration between FDA, the National Institute of Health’s National Cancer Institute, Centers for Disease Control and Prevention and Biomedical Advanced Research…
The Food and Drug Administration this week released guidance for institutional review boards seeking clarity regarding the key factors and procedures they should consider when reviewing requests by physicians and others for individual patient access to investigational drugs.