Kalamazoo, MI—As a consequence of the COVID-19 pandemic, pharmacies have become an increasingly important location for patients to access Clinical Laboratory Improvement Amendments of 1988 (CLIA) tests in the United States.

In fact, according to a recent report in the journal Research in Social and Administrative Pharmacy, drugstores now are the second largest provider of CLIA-waived tests by the total number of locations. Kalamazoo College–led researchers point out that the number of community pharmacies with CLIA-waivers grew from 10,626 (17.94%) locations in 2015 to 15,671 (27.63%) locations in 2020.

“Most of this growth occurred between 2019 and 2020 due to the COVID-19 pandemic, and concentrated efforts will be necessary to sustain this momentum,” the authors advise.

Background information in the report recounts how, to meet increased patient demand for diagnostic testing, the U.S. Department of Health and Human Services (HHS) authorized licensed pharmacists to order and administer FDA-authorized COVID-19 tests during the medical emergency.

For the study, researchers collected data from the CDC CLIA Laboratory Search website on May 3, 2015, August 4, 2019, and November 26, 2020. Results indicate that pharmacies demonstrated the largest growth both in number (4,865 new locations) and percentage (45%) of CLIA-waived facilities between 2015 and 2020. The total number of pharmacies with a CLIA-waiver grew from 10,626 (17.94%) locations in 2015 to 12,157 (21.43%) locations in 2019, and 15,671 (27.63%) locations in 2020.

States demonstrated considerable variability in the percentage of pharmacies with a CLIA-waiver, however, with a range of 2.92% to 56.52%, the study notes.

The authors describe how, in its guidance, the U.S. Department of Health and Human Services noted the close relationships pharmacists have with patients and healthcare providers as well as the close proximity of pharmacies to most Americans. At the same time, they point out, states have also rapidly expanded pharmacy-based CLIA-waived testing through both legislative and executive action to increase the capacity of providers and availability of diagnostic testing for COVID-19.

Researchers suggest that the growth in pharmacy-based CLIA-waived testing during the COVID-19 pandemic is similar to the growth in pharmacy-based vaccinations during the 2009 H1N1 influenza pandemic, explaining, “Pharmacists had started providing vaccines in community pharmacies over a decade prior to the pandemic, but the concentrated efforts to mass immunize the population permanently changed where vaccines were sought, with nearly 1 in 3 vaccines now provided in community pharmacies.”

The authors raise the question of whether this increase is sustainable or if the number of CLIA-waived pharmacies will return to prepandemic levels. One issue is that payment for pharmacy-based vaccines is supported under Medicare but is less established for testing, they note.
Another factor is the state legal environment for pharmacy-based testing, according to the study, which also points to an additional factor: the ability of pharmacists to act on the results of tests. “Influenza and Group A Streptococcus are among the most common tests provided in community pharmacies,” according to the report. “The advantage of such tests is to identify patients with these minor ailments and initiate therapy quickly. If pharmacists do not have the ability to act on the tests, there is arguably less benefit, and therefore likely less demand for these services.”

The authors point to recent changes in state laws as promising for pharmacists’ increasing ability to initiate some treatment.

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