A crucial component of the response to the coronavirus disease 2019 (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 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 the most accessible health care professional.

Therefore, on April 8, 2020, to further expand access to COVID-19 testing, the HHS issued new guidance under the Public Readiness and Emergency Preparedness Act (PREP Act). The new guidance authorizes licensed pharmacists to order and administer COVID-19 tests, including serology tests, that are approved by the FDA.

Generally, the PREP Act permits the HHS to immunize certain classes of health care professional 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, Secretary of HHS 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 in granting immunity to pharmacists who order and administer COVID-19 tests is to facilitate access to testing as current capacities cannot accommodate national and local needs.

HHS Secretary Alex Azar acknowledged pharmacists’ vital role in delivering convenient access to public health services and information

“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. 

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 healthcare.  Please contact your healthcare attorney for guidance on these and any other healthcare issues, whether or not related to COVID-19.


REFERENCES

HHS Statements on Authorizing Licensed Pharmacists to Order and Administer COVID-19 Tests [news release]. Washington, DC; April 8, 2020: HHS website. https://www.hhs.gov/about/news/2020/04/08/hhs-statements-on-authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.html Accessed April 21, 2020.