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COVID-19: FDA Expands Bivalent Vaccine EUA, HHS Amends PREP Act

The Food and Drug Administration (FDA) on April 18 amended the emergency use authorizations of the Moderna and Pfizer-BioNTech COVID-19 bivalent vaccines to allow individuals ages 65 and older who have received a single dose of a bivalent vaccine to receive one additional dose at least four months after their initial bivalent dose.

The FDA also stated that, moving forward, most unvaccinated individuals may receive a single dose of a bivalent vaccine rather than multiple doses of the original monovalent vaccines. Monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines no longer are authorized in the United States.

The agency will determine future vaccination recommendations and authorizations in June during an upcoming advisory committee meeting.

HHS Amends PREP Act

HHS announced on April 14 its intent to amend the Public Readiness and Emergency Preparedness (PREP) Act, which enabled pharmacists, pharmacy interns, and pharmacy technicians to administer COVID-19 and seasonal influenza vaccines regardless of any U.S. government agreement or emergency declaration through December 2024.

The amendment would no longer permit COVID-19 vaccination by nontraditional providers and COVID-19 vaccinations across state lines by licensed providers and pharmacists and pharmacy interns.

The impending amendments also would end PREP Act coverage for pharmacists, pharmacy interns, and pharmacy technicians conducting routine childhood vaccinations.

The act will continue to offer liability immunity for pharmacists, pharmacy technicians, and pharmacy interns dispensing COVID-19 treatments such as Paxlovid and Lagevrio.

OCR Ends Notifications of Enforcement Discretion

On April 11, the Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced that the Notifications of Enforcement Discretion issued under HIPAA and the Health Information Technology for Economic and Clinical Health (HITECH) Act will expire on May 11 when the COVID-19 public health emergency ends.

The Notice previously allowed covered health care providers to offer telehealth care through video chat applications without risking a penalty from the OCR for noncompliance with the HIPAA rules related to the good faith provision of telehealth during the COVID-19 nationwide public health emergency.

OCR will provide a 90-calendar day transition period for covered health care providers to make any necessary changes to their operations to provide telehealth securely to comply with the HIPAA rules.

The agency encourages providers to notify patients about privacy risks within third-party applications and enable all available encryption and privacy modes when using the applications.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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