Updated May 27, 2020
HHS Confirms Pharmacists’ Authority to Order and Administer COVID-19 Tests
On May 19, 2020, the Department of Health and Human Services (HHS) issued Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration Under the Act.
In this advisory opinion, HHS states that “Any state or local law or legal requirement that prohibits or effectively prohibits licensed pharmacists from ordering and administering FDA-authorized COVID-19 tests are different from or in conflict with the declaration—and therefore, a legal requirement under the PREP Act. So during the effective period of the PREP Act declaration, a state or locality cannot establish, enforce, or continue any such legal requirements under the PREP Act’s preemption provision.”
The advisory opinion goes on to state, “It is important to note that the PREP Act does not preempt all state and local legal requirements. Not all legal requirements that regulate the pharmacy profession differ from or conflict with the PREP Act or any declaration issued under that Act with respect to COVID-19 tests.”
Pharmacies interested in providing COVID-19 testing services should review TPA’s previously released COVID-19 testing guidance and Medicare enrollment email to obtain a federal CLIA waiver, to file for state-based waived testing authorization, and to enroll with Medicare as an Independent Clinical Diagnostic Laboratory.