A crucial component of the response to the COVID-19 pandemic in the United States is the swift expansion of testing capabilities at facilities of all types nationwide. Given that the vast majority of Americans live near retail or independent community-based pharmacies, the U.S. Department of Health and Human Services (HHS) concluded that pharmacists are a critical group of health care professionals who can assist in testing and should thus play a substantial role in the response to this public health emergency. Pharmacists are on the frontlines and continue to serve the general public as some of the most accessible health care professionals.
Therefore, on April 8, 2020, HHS issued new guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to further expand access to COVID-19 testing. The new guidance authorizes licensed pharmacists to order and administer COVID-19 tests, including serology tests, that are approved by the Food and Drug Administration (FDA).
Generally, the PREP Act permits HHS to immunize certain classes of health care professionals from liability – except in cases of willful misconduct – in connection with countermeasures against diseases or other threats that endanger public health, such as COVID-19. Specifically, the PREP Act authorizes HHS to declare that certain "covered persons" are immune from liability for taking necessary "covered countermeasures" in response to a public health emergency. On March 10, 2020, HHS Secretary Alex Azar issued such a declaration, effective February 4, 2020, in connection with COVID-19.
Under the new guidance, pharmacists now qualify as "covered persons" under the PREP Act. This new classification means that pharmacists will now receive immunity with respect to all claims for loss in connection with the administration or use of FDA-authorized COVID-19 tests that do not involve willful misconduct. The purpose of this policy change is to facilitate access to testing as current capacities cannot accommodate national and local needs.
"Giving pharmacists the authorization to order and administer COVID-19 tests to their patients means easier access to testing for Americans who need it," said Azar in a press release issued with the new guidance. He noted that "[p]harmacists play a vital role in delivering convenient access to important public health services and information" and the administration wants "to give pharmacists the chance to play a bigger role in the COVID-19 response."
As with other new policy guidance and policy changes, it is essential to understand how these changes fit into the existing regulatory frameworks that govern the delivery of health care. Please contact your Much attorney for guidance on these and any other health care issues.