HHS Overrides State Barriers to Pharmacist-Provided COVID-19 Testing

May 20, 2020

A new guidance from the US Department of Health & Human Services (HHS) paves the way for pharmacists nationwide to administer coronavirus disease 2019 (COVID-19) tests.

A new guidance from the US Department of Health & Human Services (HHS) paves the way for pharmacists nationwide to administer coronavirus disease 2019 (COVID-19) tests. The

, issued on May 19, overrides state and local rules preventing pharmacists from administering COVID-19 diagnostic tests.1

“We have received requests from pharmacists, pharmacies, and one trade association asking the Office of the General Counsel (OGC) whether the Public Readiness and Emergency Preparedness (PREP) Act preempts state licensing laws that restrict the ability of pharmacists to order and administer COVID-19 diagnostic tests where the Department of Health and Human Services (HHS) has expressly authorized pharmacists, under the PREP Act, to order and administer those tests,” HHS said.1

“For the reasons and subject to the limitations set forth below, we conclude that the PREP Act, in conjunction with the Secretary’s March 10, 2020 declaration, preempts any state or local requirement that prohibits or effectively prohibits a pharmacist from ordering and administering a COVID-19 diagnostic test that the Food and Drug Administration (FDA) has authorized,” the agency added.1

When the authorization was granted on April 8 allowing pharmacists to provide COVID-19 testing, HHS Secretary Alex Azar said that “pharmacists play a vital role in delivering convenient access to important public health services and information.”

The new guidance demonstrates that pharmacists should be able to order and provide COVID-19 testing, NCPA said in a press release.2 “There are 21,000 independent pharmacists across the country. Thanks to the secretary’s decision, they can now make an even bigger contribution to the war against COVID-19.”

“More widespread testing is the key to winning this battle. The faster we can expand testing, the sooner we can get back on our feet economically. Pharmacists are the country’s most accessible health care providers and they have been on the front lines since the beginning of the pandemic. They are well positioned to expand testing rapidly and safely,” NCPA added in the statement.2

At least 34 states have taken action to remove remaining barriers to pharmacists administering COVID-19 tests, NACDS said in an advisory to its members. “NACDS pursued a dual track of vigorously and comprehensively advocating for the removal of remaining barriers in the states, while seeking additional clarity in federal policy, so pharmacies could help the nation scale testing as supplies become more commercially available,” the organization said.3

NACDS will be discussing with its committees, councils, and task forces the effects of HHS’ “seemingly pivotal, advisory opinion,” the group said.3 “We will determine the appropriate path forward to ensure the removal of any remaining barriers, to continue to address reimbursement issues related to COVID-19 testing, and to ensure pharmacies and pharmacists are empowered all the more to help protect public health and to help reopen our states and nation for good.”

References:

1. US Department of Health & Human Services. Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration Under the Act. May 19, 2020. Accessed May 20, 2020.

2. NCPA Statement on HHS Guidance Clarifying COVID-19 Testing by Pharmacists. News Release. NCPA; May 20, 2020. Accessed May 20, 2020. https://ncpa.org/newsroom/news-releases/2020/05/20/ncpa-statement-hhs-guidance-clarifying-covid-19-testing

3. HHS Advisory Opinion further Supports Pharmacist-Provided Testing: Federal Action Preempts State, Local Policies. News Release. NACDS; May 20, 2020. Accessed May 20, 2020. https://www.nacds.org/news/hhs-advisory-opinion-further-supports-pharmacist-provided-covid-19-testing-federal-action-preempts-state-local-policies/.