Policy Updates

3/1/22 — The FDA is warning people not to use certain COVID-19 rapid antigen tests that have not been authorized, cleared, or approved by the FDA for distribution or use in the United States. These tests include, Celltrion USA Inc. DiaTrust COVID-19 Ag Rapid Tests the SD Biosensor STANDARD Q COVID-19 Ag Home Test, and the ACON Flowflex SARS-CoV-2 … Continued

2/28/22 — According to a February 2022 Conformity Assessment Letter to Manufacturers, NIOSH will give approval priority to applications for filtering air-purifying respirators that are produced in the United States. This includes filtering facepiece respirators (e.g. N95s) and powered air-purifying respirators (PAPRs). Read the NIOSH letter.

The FDA issued an emergency use authorization (EUA) for a new monoclonal antibody for the treatment of COVID-19 that retains activity against the omicron variant. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older) with a positive COVID-19 test, and who are … Continued

SD Biosensor, Inc. is voluntarily recalling its STANDARD Q COVID-19 Ag Home Test in the United States, due to confirmed reports that the test kits were illegally imported into the United States. The STANDARD Q COVID-19 Ag Home Test is not authorized, cleared or approved by the U.S. Food and Drug Administration (FDA) for distribution … Continued

COVID-19 Updates: What Clinicians Need to Know About Multisystem Inflammatory Syndrome in Children Multisystem inflammatory syndrome in children (MIS-C) is a rare but severe condition associated with SARS-CoV-2 infection. The Centers for Disease Control and Prevention (CDC) has been actively involved in MIS-C surveillance and research, and development of MIS-C resources to support the public … Continued

The U.S. Food and Drug Administration (FDA) is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test (DART). This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by the … Continued

2/3/22 — The next CMS Long-Term Services and Supports Open Door Forum scheduled for:   Date: Wednesday, February 9, 2022Start Time: 1:00 PM Eastern Time (ET);Conference Leaders: Jodie Sumeracki, CMCS and Jill Darling, CMS Office of Communications Chair – Jodie Sumeracki (CMCS)Moderator – Jill Darling (OC) Announcements & Updates Brief overview of several recent guidance documents and resources … Continued

1/28/22 — The Food and Drug Administration (FDA) issued a safety communication warning people to stop using the Empowered Diagnostics CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test. These tests were distributed with labeling indicating they are authorized by the FDA, but neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States. The … Continued

1/31/22 — The FDA has granted approval of the Moderna COVID-19 vaccine for individuals age 18 and older. The vaccine will be marketed as Spikevax. Read the FDA announcement.