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HHS Guidance on Authorizing Licensed Pharmacists to Order and Administer COVID-19 Tests

April 09, 2020

On April 8, 2020, Health and Human Services (HHS) published guidance under the Public Readiness and Emergency Preparedness (PREP) Act authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests, for the duration of the national public health emergency, declared January 31, 2020.

In announcing this guidance, HHS Assistant Secretary for Health Brett P. Giroir, M.D., stated:

"In an effort to expand testing capabilities, we are authorizing licensed pharmacists to order and administer COVID-19 tests to their patients. The accessibility and distribution of retail and independent community-based pharmacies make pharmacists the first point of contact with a healthcare professional for many Americans. This will further expand testing for Americans, particularly our healthcare workers and first responders who are working around the clock to provide care, compassion, and safety to others."

Importantly, the guidance does not address the issue of payment for testing or propose any alternative mechanisms to provide for an ongoing, sustainable model for care delivery. Specifically, HHS states:

“This guidance does not speak to or change reimbursement policy whether a licensed pharmacist may obtain reimbursement from a government or private payer for ordering or administering an FDA-authorized test.”

ACCP applauds the leadership of HHS in utilizing pharmacists as members of the health care team as part of its emergency response effort and for recognizing the central role of America’s community pharmacies in providing front line services.

However, as we evaluate the guidance and work to support the development of best practices with our pharmacy and non-pharmacy colleagues, we have identified a number of key questions related to safety, accuracy, reporting, and epidemiologic surveillance where we aim to seek further clarification:

  • Safety: provisions to ensure pharmacists and pharmacy staff have access to personal protective equipment (PPE) and guidance on its appropriate use, recognizing well-documented shortages and supply chain issues.
  • Accuracy of testing: determining the reliability of test results and associated quality assurance processes.
  • Reporting and documentation of test results: timely documentation and reporting of test results to patients and providers.
  • Public health epidemiologic surveillance: ensuring the systematic collection, analysis, and interpretation of testing data.

Through our collaborative efforts within the pharmacy profession and with external partners, ACCP is working to help align the appropriate resources and expertise within the profession with the complex needs within our care delivery systems as part of this emergency response. We continue to advocate on behalf of the profession to ensure our members are utilized to practice safely and effectively within team-based practice as they contribute their unique expertise to help optimize medication use.

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