Pharmacy-based CLIA-waived testing in the United States: Trends, impact, and the road ahead

Federal authorization of the use of Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived point-of-care tests for SARS-CoV-2 by pharmacists during the pandemic resulted in a dramatic rise in the number of community pharmacies that became CLIA-waived test sites. Now as we exit the pandemic, the wide-ranging expansion of the scope of practice facilitated currently by the PREP Act is set to expire in fall 2024. As a result, American pharmacists' ability to offer CLIA-waived testing services will revert to a patchwork of state laws.

This study aims to examine both the number of pharmacies in the United States with CLIA Certificates of Waiver before and after the SARS-CoV-2 pandemic and the state-by-state differences in the percentage of pharmacies with CLIA Certificates of Waiver.

Data were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website on May 3rd, 2015, August 4th, 2019, November 26th, 2020, October 6th, 2021, November 23rd, 2022, and December 4th, 2023. The website allows for the exportation of demographic data on all CLIA-waived facilities by state.

The total number of pharmacies with a CLIA-waiver grew from 10,626 (17.9%) locations in 2015 to 12,157 (21.4%) locations in 2019, to 15,671 (27.6%) locations in 2020, and to 29,011 (51.6%) locations in 2023. States demonstrated considerable variability in the percentage of pharmacies possessing a CLIA certificate of waiver in 2023, with a range of 10.7%-87.9%.

Use of CLIA-waived tests in pharmacies has grown by 140% since 2019. The time period from 2019 to 2021 witnessed a 92.5% increase in pharmacies that possessed a certificate of waiver which was largely driven by the pandemic. Interestingly, from 2021 to 2023 the was continued growth in the market of 31.6%. This suggests that pharmacies continue to see opportunity in offering CLIA-waived testing services beyond those that had been extended as a result of the pandemic.