Public Policy Updates

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.

1/26/22 — Following the recent Supreme Court ruling striking down the OSHA COVID-19 Vaccination and Testing Emergency Temporary Standard (ETS), OSHA is withdrawing the ETS effective January 26. Neither this OSHA ETS nor the Supreme Court ruling pertained to healthcare personnel vaccination; however, healthcare personnel employed by facilities receiving Medicare/Medicaid reimbursement are required to receive COVID-19 … Continued

1/14/22 — Following the January 13 Supreme Court decision upholding the CMS Omnibus COVID-19 Health Care Staff Vaccination interim final rule, CMS updated its guidance and survey procedures for assessing and maintaining compliance with these regulatory requirements. This guidance specifically applies to the following states: Alabama, Alaska, Arizona, Arkansas, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, … Continued

1/13/22 — The U.S. Supreme Court ruled in two different cases to uphold the CMS COVID-19 vaccination mandate for healthcare personnel and to strike down the OSHA COVID-19 vaccination and testing emergency temporary standard (ETS). In a 5-4 decision the case of Biden v. Missouri, the Court ruled that CMS was within its authority in imposing the … Continued

1/14/22 — HHS Secretary Xavier Becerra renewed the COVID-19 public health emergency (PHE), effective January 16, 2022. A PHE remains in effect for 90 days but may be extended. Read the secretary’s statement.