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.

A new Centers for Medicare & Medicaid Services bulletin reviews the anticipated end dates for certain COVID-19-related Medicaid and Children’s Health Insurance coverage flexibilities.
Consumers and health care providers should not use certain SD Biosensor Pilot COVID-19 At-Home Tests distributed by Roche Diagnostics due to bacterial contamination, but throw them in the trash, the Food and Drug Administration announced.
The Centers for Disease Control and Prevention April 19 recommended a second Moderna or Pfizer COVID-19 bivalent vaccine dose for adults aged 65 and older at least four months after their initial bivalent dose, and for immunocompromised individuals at least two months after their initial bivalent…
If President Biden signs as expected Congress’ joint resolution ending the COVID-19 national emergency immediately, the Centers for Medicare & Medicaid Services’ COVID-19 waivers and flexibilities will remain in place through May 11 as planned.
The Centers for Medicare & Medicaid Services yesterday released FAQs on COVID-19 coverage after the public health emergency ends.
The Food and Drug Administration today released final guidance for transitioning medical device enforcement policies and emergency use authorizations established during the COVID-19 public health emergency to normal operations.
The Food and Drug Administration will end 22 COVID-19-related policies when the public health emergency ends May 11 and allow 22 to continue for 180 days, including temporary policies for outsourcing facilities compounding certain drugs for hospitalized patients and non-standard personal protective…
The Centers for Medicare & Medicaid Services yesterday released a fact sheet summarizing the status of public and private coverage for COVID-19 vaccines, testing, and treatments and certain blanket waivers for health care providers once the public health emergency ends on May 11.
In an online survey last November of 1,200 U.S. adults previously vaccinated against COVID-19, 62% had not yet received a bivalent booster dose, most often because they did not know they were eligible or the booster was available, or believed they were immune against infection.
During the COVID-19 public health emergency, CMS will continue to exercise enforcement discretion under the Clinical Laboratory Improvement Amendments to allow providers to test asymptomatic individuals using certain point-of-care SARS-CoV-2 tests authorized for symptomatic individuals, CMS…