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 said that Moderna can add up to 50% more doses per vial of its COVID-19 vaccine. Moderna had been shipping 10-dose vials; the FDA’s change will enable shipments to contain up to 15 doses per vial. 
The Federal Communications Commission adopted a report and order implementing changes to the COVID-19 Telehealth Program under the Consolidated Appropriations Act, which authorized an additional $249.95 million in funding for the program.
The Centers for Medicare & Medicaid Services released an article informing all Medicare providers and suppliers who requested and received COVID-19 Accelerated and Advance Payments that it began recovering those payments March 30, depending on the one-year anniversary of their first payment.
The Food and Drug Administration has launched a webpage on the impact of viral mutations on COVID-19 tests, including recommendations for clinical laboratory staff and health care providers using the tests. 
The Food and Drug Administration recently issued an emergency use authorization for a next generation sequencing test to detect SARS-CoV-2 in respiratory specimens from individuals suspected of COVID-19 by their health care provider.
The Pfizer and Moderna COVID-19 vaccines reduced the risk of both asymptomatic and symptomatic SARS-CoV-2 infection by 90% at least two weeks after the second dose and by 80% at least two weeks after the first dose in a study of 3,950 vaccinated health care and other essential workers, the Centers…
The Centers for Medicare & Medicaid Services today announced the immediate resumption of survey activities for all complaints. On Jan. 20, 2021, CMS issued guidance limiting hospital surveys for all complaints other than Immediate Jeopardy (IJ) complaints. The suspension period lasted for 30…
The Food and Drug Administration authorized for emergency use an armband device that screens people without COVID-19 symptoms for certain potential SARS-CoV-2 biomarkers, such as excessive blood clotting. 
The Department of Health and Human Services (HHS) March 19 updated its guidance to hospitals on the reporting of COVID-19-related data.
The Food and Drug Administration yesterday updated the health care provider fact sheets for all three monoclonal antibody therapies authorized for emergency use to include information on whether SARS-CoV-2 variants may show resistance to that therapy.