CLIA Waiver Pharmacy Growth

As the demand for medical care continues to grow faster than supply, the United States will likely face a large shortage of primary care physicians in the near future. Expanding the role of nonphysician practitioners, such as pharmacists, in the provision of health care is one possible solution to this pending crisis.

A new study published by the Mercatus Center at George Mason University addresses concerns about whether these practitioners can efficiently absorb the additional responsibilities into their workflow, and it finds that pharmacists and lab technicians appear to be capable of providing low-risk medical tests without significantly affecting the number of hours worked.

Saint Francis University Associate Professor Edward J. Timmons and Mercatus MA Fellow Conor S. Norris examine the effects of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which allow pharmacies to apply for waivers to conduct low-risk medical tests, and they conclude that broadening the scope of practice for pharmacists may help alleviate the rising costs of providing health care in the United States.

THE INCREASING USE OF CLIA WAIVERS

• CLIA legislation was facilitated by rapid advances in medical technology—most notably handheld testing devices that personnel with limited medical training can operate.
• Substantial state-to-state variation in the requirements for obtaining CLIA waivers has slowed their adoption and still appears to affect the distribution of CLIA pharmacies.
• By 2014, every state except Hawaii had CLIA waiver pharmacies, with Washington, Illinois, California, and Texas each home to more than 500 CLIA waiver pharmacies. In fact, Texas alone had more than 1,000 such pharmacies.

EFFECTS ON PHARMACIST AND TECHNICIAN LABOR MARKETS

• Econometric analysis using 2000–2014 data drawn from the American Community Survey shows little evidence that the spread of CLIA pharmacies is affecting the number of hours pharmacists and lab technicians are working, indicating that routine testing can be incorporated into pharmacists’ existing work schedules with little disruption.
• A separate analysis that takes into account the possibility of broad changes in the healthcare market confirms the above finding.
• These results imply that pharmacies can accommodate routine medical testing in employees’ current job duties without causing significant disruption in their ability to dispense prescription drugs.

CONCLUSION

Though nonphysician healthcare professionals may not be equipped to substitute for physicians in every capacity, a variety of professionals, including pharmacists, can help bring affordable health care to those who need it most. States that currently make it onerous for pharmacists to obtain CLIA waivers should consider relaxing restrictions and allowing pharmacies to expand their role in the provision of healthcare services. Expanding the roles of nonphysician medical practitioners to allow the provision of health care to expand without significantly increasing its cost seems to be the right prescription for the US healthcare market.