Impact of COVID-19 on prevalence of community pharmacies as CLIA-Waived facilities

Abstract

Background The Clinical Laboratory Improvement Amendments of 1988 (CLIA) enabled greater access to low-risk tests by allowing their use in facilities with a Certificate of Waiver in the U.S. Recently, the 2019 novel coronavirus (COVID-19) pandemic has shined a spotlight on CLIA-waived diagnostic testing. To meet this 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. Objective This study aims to update the previous national benching report and 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. Methods Data were collected from the U.S. Centers for Disease Control and Prevention CLIA Laboratory Search website May 3rd, 2015, August 4th, 2019 and November 26th, 2020. The website allows for exportation of demographic data on all CLIA-waived facilities by state. Results Pharmacies exhibited the largest growth both in number (4865 new locations) and by percent (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, to 15,671 (27.63%) locations in 2020. States demonstrated considerable variability in the percentage of pharmacies with a CLIA-waiver, with a range of 2.92%–56.52%. Conclusions Pharmacies have become an increasingly important location for patients to access CLIA-waived tests in the United States, now serving as the second largest provider of CLIA-waived tests by the total number of locations. 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.

Pharmacist scope of practice expansion: The virtue of forbearance

“…Thus, even with significant federal support of pharmacy-based testing to increase access to testing during the COVID-19 global pandemic, more than 70% of pharmacies did not obtain the CLIA-waiver necessary to provide testing services. 15,16 Limited uptake is also observed with the 2.4% of North Carolina pharmacists who have sought the Clinical Pharmacist Practitioner designation or the 11.1% of California pharmacies offering contraceptive services. 17,18 Perhaps the most significant example of forbearance is Alberta pharmacists who may legally prescribe nearly any medication under provincial law.…”

“…Per the aforementioned studies, barriers include consumer acceptance and demand, payer policies, facility policies such as staffing, threat of civil liability, professional ethics and restraint, and in some cases, stigma of the patient population seeking the service. 5,[9][10][11][12][13][14][15][16][17][18][19][20][21][22][23] It can take significant lead time to overcome these barriers.…”

“…In 2015, just 17.9% of pharmacies held a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver; this grew to just 27.6% of pharmacies in 2020. Thus, even with significant federal support of pharmacy‐based testing to increase access to testing during the COVID‐19 global pandemic, more than 70% of pharmacies did not obtain the CLIA‐waiver necessary to provide testing services 15,16 …”

“…What may appear as practice inertia is more a result of the complex milieu of market forces governing the pharmacy profession. Per the aforementioned studies, barriers include consumer acceptance and demand, payer policies, facility policies such as staffing, threat of civil liability, professional ethics and restraint, and in some cases, stigma of the patient population seeking the service 5,9‐23 …”

Pharmacy-Based Point-of-Care Testing: How a “Standard of Care” Approach Can Facilitate Sustainability

“…The number of pharmacies providing testing services grew by 45% between 2015 and November 2020, with the largest gains occurring in the last year amid the pandemic. 4 Sustaining the growth of pharmacy testing services will require concentrated efforts, including the development of a more supportive regulatory environment. State-level regulatory impediments have been known to limit uptake of POCT services at pharmacies.…”