Public Policy Updates

The FDA revised the Letters of Authorization for two EUAs, Paxlovid and Lagevrio, to remove the requirement for positive test results to prescribe these products. The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19. However, we recognize that, in rare instances, individuals with a recent known exposure (e.g., a household contact) … Continued

The White House issued a Statement of Administration Policy about its plan to extend the COVID-19 national emergency and public health emergency (PHE) to May 11 and then end both emergencies on that date. This wind-down would align with the Administration’s previous commitments to give at least 60 days’ notice prior to termination of the … Continued

The CDC issued a Health Alert Network (HAN) Health Advisory about infections with an extensively drug-resistant strain of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) in 12 states. The majority of patients reported using EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles. As a result, the FDA issued a warning to … Continued

A report from the CDC, “Health Disparities in Hemodialysis-Associated Staphylococcus aureus Bloodstream Infections – United States, 2017 – 2020,” noted that while vascular access type was the major risk factor for hemodialysis-associated S. aureus bloodstream infections (BSI), race, ethnicity, and socioeconomic factors also affected infection rates and distribution. More than 800,000 adults in the U.S. live with … Continued

Based on data that show Evusheld in unlikely to be effective against SARS-CoV-2 variants currently circulating in the U.S., the FDA announced that Evusheld is not currently authorized for use in the U.S. until further notice. Read the FDA announcement.

In the second of three reports, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) found that during the pandemic surges of 2020, more than 1,300 nursing homes had COVID-19 infection rates of 75 percent or more among their Medicare beneficiaries. The report also found that the survey process did … Continued

CMS issued a Quality, Safety & Oversight Group memo (QSO-23-05-NH) providing updates to the Nursing Home Care Compare Website and Five Star Quality Rating System. Among the process revisions noted in the memo, as part of CMS’s commitment to transparency, the agency will allow consumers to see all of the citations a facility received regardless … Continued

The U.S. Government Accountability Office issued a report, “Public Health Preparedness: HHS Could Improve Oversight of Research Involving Enhanced Potential Pandemic Pathogens.” The report’s recommendations include:

The CDC’s Clinician Outreach and Communication Activity (COCA) team is sponsoring a webinar on Tuesday, January 24 at 2 – 3 pm ET. On the call, CDC experts will provide an overview of COVID-19 epidemiology and the current variant landscape, and address current CDC testing guidance and the National Institutes of Health and Infectious Disease … Continued