On Wednesday, April 8, 2020, the U.S. Department of Health & Human Services (HHS) Office of the Assistant Secretary for Health released guidance authorizing pharmacists to “order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized.”  HHS noted that it recognized that most Americans are relatively close to a retail pharmacy and they interact with pharmacists more frequently than other healthcare professionals. Allowing pharmacists to administer the tests should reduce travel to testing locations – an important mitigation step.  HHS Secretary Alex Azar issued the following statement:

“Giving pharmacists the authorization to order and administer COVID-19 tests to their patients means easier access to testing for Americans who need it. Pharmacists play a vital role in delivering convenient access to important public health services and information. The Trump Administration is pleased to give pharmacists the chance to play a bigger role in the COVID-19 response, alongside all of America’s heroic healthcare workers.”

In its guidance, HHS also granted licensed pharmacists immunity when administering or using FDA-authorized COVID-19 tests and stated that they will be considered a “covered person” under the Public Readiness and Emergency Preparedness Act when taking such actions. This immunity for “covered persons” is extremely broad. It protects individuals from all claims or losses caused by, arising out of, relating to, or resulting from, the administration or use of FDA-authorized COVID-19 tests.

Finally, HHS noted that the guidance does not address or change whether pharmacists may be reimbursed for ordering or providing such tests under the federal healthcare programs or other third-party payors.

We previously released recorded webinars related to the pharmacies’ and pharmacists’ roles and responsibilities during the COVID-19 public health emergency. You can find the most recent recording here.  For more information, or if you have any questions, please contact one of our Husch Blackwell healthcare attorneys.