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.

To ensure that COVID-19 tests work as intended, the Food and Drug Administration will now enforce premarket review requirements for laboratory developed tests, reversing the prior administration’s policy, Health and Human Services Secretary Xavier Becerra announced. 
The Centers for Disease Control and Prevention will implement three new ICD-10 diagnosis codes for reporting COVID-19 vaccination status effective April 1, 2022.
Ellume has expanded its recall of rapid at-home COVID-19 antigen tests to about 2 million tests, the Food and Drug Administration said in an update this week.
Pfizer asked the Food and Drug Administration to amend the emergency use authorization for its COVID-19 vaccine to allow all individuals age 18 and older to receive booster shots.
The Centers for Medicare & Medicaid Services will host a Nov. 10 call on its recent interim final rule requiring COVID-19 vaccinations for workers in most health care settings that participate in the Medicare and Medicaid programs, including hospitals and health systems.
The Centers for Medicare & Medicaid Services issued an interim final rule requiring COVID-19 vaccinations for workers in most health care settings, including hospitals and health systems, that participate in the Medicare and Medicaid programs.
Centers for Disease Control and Prevention Director Rochelle Walensky, M.D., accepted the recommendation of her agency’s independent Advisory Committee on Immunization Practices to administer Pfizer’s pediatric COVID-19 vaccine to children between the ages of five and 11.
The Centers for Disease Control and Prevention’s independent Advisory Committee on Immunization Practices recommended Pfizer’s COVID-19 vaccine be administered for children ages five through 11.
Health care providers should not purchase or use certain imported medical gloves from certain companies, which appear to have been reprocessed, cleaned or recycled and sold as new, the Food and Drug Administration announced.
Moderna announced an updated timeline for its COVID-19 vaccine for children. According to Moderna, the Food and Drug Administration last week notified the drug maker that it may not complete its assessment of the company’s EUA request for children age 12 to 17 before January 2022.