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On January 28, 2021, Norris Cochran, the acting secretary of the U.S. Department of Health and Human Services (HHS), amended the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (PREP Act Declaration) in order to address the need to expand the pool of COVID-19 vaccinators to increase access to COVID-19 vaccinations. As background, the PREP Act (42 U.S.C. § 247d-6d) authorizes the secretary of HHS to issue a declaration to immunize certain individuals including “qualified persons” and entities (Covered Persons) against any claim of loss related to “Covered Countermeasures.” Former Secretary Alex Azar issued his initial COVID-19 PREP Act Declaration on March 10, 2020.
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Back in March, we wrote about how the Department of Health and Human Services (HHS) had extended the Public Readiness and Emergency Preparedness (PREP) Act to grant immunity to “Covered Persons” providing “Covered Countermeasures” against COVID-19. The Office of the General Counsel for HHS issued an omnibus advisory opinion on April 14 that addressed common questions and concerns about the scope of PREP Act immunity, as discussed in our April update. Last month, we described how courts across the country have interpreted the PREP Act in the context of the ongoing pandemic.
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On December 3, 2020, HHS issued its fourth amendment to the Declaration for Medical Countermeasures Against COVID-19 under the Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act authorizes the Secretary of HHS to issue a declaration to provide liability protections to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from, the manufacture, distribution, administration, or use of certain medical countermeasures (Covered Countermeasures). Among other measures, the amendment authorizes qualified healthcare personnel using telehealth to order or administer medical Covered Countermeasures for patients in a state other than the state where the healthcare personnel are already permitted to practice.