The Office of the Assistant Secretary for Health issued new guidance under the Public Readiness and Emergency Preparedness Act (“PREP Act”) designed to expand COVID-19 testing capabilities by relaxing pharmacy regulations. Under the new guidance, licensed pharmacists, who often are the most accessible and the first healthcare professionals contacted by many individuals, may order and administer COVID-19 tests, including serology tests, authorized by the FDA. These pharmacists qualify as “covered persons” under the PREP Act, and thus will have the benefit of the Act’s immunity protection for all claims--except for death or serious physical injury caused by willful misconduct--for any loss, including death and physical or mental injury resulting from the administration or use of these tests as a covered countermeasure. The guidance does not change government or private payer reimbursement rules.

The full guidance document can be found here.