Policy Updates

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.

1/13/22 — In the FY 2022 Hospital Inpatient Prospective Payment System (IPPS) final rule, CMS implemented a “Measure Suppression Policy.” Under this policy, CMS will not use certain measures (including NHSN HAI measures) from the Q3 and Q4 2020 reporting periods for performance scoring in the Hospital-Acquired Condition (HAC) Reduction Program and the Hospital Value-Based … Continued

1/11/22 — CMS has updated its “Nursing Home Visitation FAQs” document to provide additional clarification on its revised guidance issued in November 2021. The key message is that visitation must be permitted at all times with very limited and rare exceptions, in accordance with residents’ rights. Nursing homes should enable visitation following these three key points: • Adhere to … Continued

1/11/22 — NIOSH has honored a request by ALG Health to voluntarily rescind ALL NIOSH respirator approvals issued to ALG Health. As of January 6, 2022, any respirator marked with a NIOSH approval label indicating any of the following approval numbers is no longer NIOSH-approved. TC-84A-9259, TC-84A -9262, TC-84A-9270, TC-84A-9271, TC-84A-9273, TC-84A-9274, TC-84A-9275, TC-84A-9280, TC-84A-9281, TC-84A-9282, TC- 84A-9288, … Continued