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’s Vaccines and Related Biological Products Advisory Committee Dec. 10 recommended the approval of Pfizer, Inc.’s BNT162b2 mRNA COVID-19 vaccine. The panel voted 17-4, with one abstention, that FDA issue an emergency use authorization.
The Food and Drug Administration authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by adults without a prescription.
The Centers for Medicare & Medicaid Services updated its FAQs regarding coverage, billing and payment for monoclonal antibody therapies used to treat COVID-19.
The Department of Health and Human Services (HHS) yesterday updated its guidance to hospitals on the reporting of COVID-19-related data. The guidance includes two key changes stemming from the Centers for Medicare & Medicaid Services’ (CMS) Dec.
The AHA Friday, Dec. 11 at 3 p.m. ET will host a call with officials from the Centers for Disease Control and Prevention on COVID-19 vaccine distributions.
Patients should not wear face masks, such as surgical or non-surgical masks and respirators, with metal parts and coatings during a Magnetic Resonance Imaging exam, because they may become hot and burn the patient, the Food and Drug Administration reminded patients and health care providers.
The Centers for Medicare & Medicaid Services updated its guidance on enforcement discretion during the COVID-19 public health emergency for laboratories performing molecular and antigen tests for the virus on asymptomatic individuals at the point of care or in patient care settings operating…
The Centers for Medicare & Medicaid Services Dec. 9 at 4 p.m. ET will host a call to discuss recent flexibilities the agency announced to allow acute health care services to be provided outside of a hospital setting in response to the surging COVID-19 pandemic.
The Food and Drug Administration released a briefing document on Pfizer’s BNT162b2 COVID-19 vaccine candidate that confirms the drug maker’s claims of the vaccine’s efficacy and safety.
The Centers for Disease Control and Prevention has published an addenda with instructions for implementing six new ICD-10 diagnosis codes for reporting COVID-19-related conditions on health care claims effective Jan. 1.