(April 21, 2023) – PREP Act Amendments
The U.S. Department of Health and Human Services announced on April 14 the agency's intent to amend the Public Readiness and Emergency Preparedness Act related to vaccines, tests and treatments for COVID-19. Primarily, these amendments center around pharmacists retaining the ability to provide COVID-19 vaccines and testing, regardless of the emergency declaration, through December 2024. The PREP Act also contains liability protections for providers administering COVID-19 vaccines, tests and treatments.
Fentanyl Combined with Xylazine Designated as an Emerging Threat
The White House Office of National Drug Control Policy has designated fentanyl combined with xylazine as an emerging threat to the United States. Xylazine is a non-opioid tranquilizer approved by the Food and Drug Administration (FDA) for veterinary use but not human use. Xylazine combined with fentanyl is being sold illicitly across the country and is associated with fatal overdoses and severe morbidity. ONDCP announced it is convening an interagency working group to inform the development of a national response plan.
EUA Available for New COVID-19 Therapeutic
The Food and Drug Administration issued emergency use authorization for Gohibic (vilobelimab), which is an injection for the treatment of COVID-19. This therapeutic is for hospitalized adult patients with COVID-19 who are on a ventilator or receiving ECMO. Gohibic can be given as many as six times throughout the treatment period. Fact sheets for health care providers, as well as patients and caregivers, are available.
OCR Announces End to HIPAA Enforcement Discretion
The Office for Civil Rights announced it will cease exercising enforcement discretion for certain violations of the Health Insurance Portability and Accountability Act when the COVID-19 PHE expires on Thursday, May 11. During the pandemic, OCR published four notifications describing how it would waive enforcement of HIPAA violations for community-based COVID-19 testing sites, telehealth communications, disclosures of PHI to business associates, and online or web-based scheduling applications for COVID-19 vaccinations.
OCR is allowing a 90-day transition period following the expiration of the waivers for providers to come into full compliance with HIPAA rules associated with these topics.
Before You Go ...
- HRSA is hosting a webinar at 1 p.m. Wednesday, May 10, to provide details on the following funding opportunities available to nurses, students and graduates.
- The Centers for Medicare & Medicaid Services released its Medicaid and Children's Health Insurance Program Beneficiary Profile for 2023. The report and infographic provide information on enrollment, expenditures, characteristics and health status of beneficiaries by state.
- According to a study released by the National Council of State Boards of Nursing, the nursing shortage crisis will continue without concerted action. The study found that an estimated 97,000 RNs left the workforce during the past two years due to stress, burnout and retirements, and another 610,388 reported an intent to leave during the next five years.
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