As COVID-19 cases continue heading toward a third calendar year, and diagnosis and treatments continue to evolve, the expectations of a high volume of malpractice cases has not come to fruition due to enhanced protection from state attorney generals and governors, along with previous protection from the Public Readiness and Emergency Preparedness (PREP) Act.
The PREP Act authorizes the Secretary of Health and Human Services (HHS) to limit the legal liability and responsibility for losses that occur during the implementation of medical countermeasures including diagnostics, treatments, vaccines and other emergency services.
By the beginning of the COVID-19 outbreak in February 2020, the Secretary of HHS invoked the PREP Act as COVID-19 was declared a public emergency. Many legal and medical experts alike still thought there was a reasonable chance that liability could be restored within the year, not recognizing the long-term effect COVID-19 was going to have across society.
To quell any chances of a backlog of malpractice cases once COVID-19 subsided, several state governors and attorneys general took the initiative to implement further protection for the health care industry against future malpractice cases. From a federal standpoint, HHS has continued to add new amendments to further protect health organizations.
After adding two amendments in August and December 2020, covering the expanded category and definition of disease and covered persons and reinforcing HHS advisory opinions, the new Biden administration has added several amendments since taking office in January 2021. The Acting Secretary of HHS issued three amendments to “expand the pool of COVID-19” vaccinators to more than just providers already licensed in a certain state. The amendments broadened the definitions of “covered persons” who may serve as COVID-19 vaccinators according to HHS guidelines.
The end of summer saw additional amendment activity as the Eighth Amendment was added in early August to expand coverage to state-licensed pharmacists who administer the vaccine for adults or children. The amendment also clarifies personnel considered as qualified personnel and extends liability protections through October 1, 2024, unless the emergency is declared over before.
Finally, on Sept. 14 the Ninth Amendment further expanded the pool of providers who may administer COVID-19 therapeutics, including monoclonal antibodies. The amendment authorizes state-licensed pharmacists, interns and qualified pharmaceutical technicians to administer those therapeutics, taking state law requirements into considerations.
The malpractice environment with COVID-19 will continue to develop, as does the disease, and expect state and federal governments to take the initiative to prevent a bottleneck of malpractice cases in the future.
6,504 Comments