State governments can reduce the costs of health care by allowing more pharmacists to write prescriptions and administer certain medical screenings, a study by the Mercatus Center at George Mason University has found.
The Clinical Laboratory Improvement Amendments (CLIA), national legislation passed in 1988, permits pharmacies to apply to the Centers for Medicare and Medicaid Services (CMS) for a waiver allowing their personnel to administer routine and highly accurate medical tests, such as for pregnancy, strep throat, and high cholesterol.
To obtain a CLIA waiver, a pharmacy must meet federal requirements, in addition to requirements that “vary substantially from state to state,” according to the October 2016 study, titled “CLIA Waiver Pharmacy Growth: How Does Broadening Scope of Practice Affect the Pharmacist Labor Market?”
As of 2014, Hawaii was the only state without a pharmacy operating under a CLIA waiver, and only two Nevada pharmacies had obtained CLIA waivers as of 2016, the study states. Texas has more than 1,000 pharmacies with CLIA waivers.
“States that currently make it onerous for pharmacists to obtain CLIA waivers (e.g., Nevada) should consider relaxing restrictions to allow pharmacies to expand their role in the provision of healthcare services,” authors Edward J. Timmons and Conor Norris wrote. “Expanding the roles of existing professionals should allow the provision of health care to expand without significantly expanding cost—and this seems to be the right prescription for what ails the US market for health care.”
Solutions Available Since 1988
The United States will face a shortage of 20,400 primary care physicians in 2020, the U.S. Department of Health and Human Services reported in 2013.
Timmons, an associate professor of economics and director of the Center for the Study of Occupational Regulation at Saint Francis University, says one solution to the expected physician shortage is expanded use of the decades-old CLIA law.
“Pharmacists can play a greater role in the provision of health care in the United States,” Timmons told Health Care News. “Federal law passed more than 20 years ago allows pharmacists to obtain a [CLIA] waiver to perform routine medical testing.”
CLIA, State to State
The process for obtaining a CLIA waiver varies by state. In general, pharmacists must meet certain standards and pay biennial certification fees. Washington State grants CLIA waivers to pharmacies with medical testing performance licensure from the state, according to the study.
Other states mandate pharmacy lab staffers get licensed individually or have a medical physician serve as a pharmacy lab director.
States with more-stringent CLIA waiver requirements than those imposed by CMS have fewer pharmacies authorized to perform routine tests, Timmons says.
“Some states have regulation that significantly increases the expenses associated with obtaining the waiver,” Timmons said. “As a result, states in the northeast and Nevada have very few pharmacies with CLIA waivers. This reduces competition in the marketplace and likely leads to higher prices of and less access to health care.”
Collaborative Practice Agreements
Dr. Michael E. Klepser, a professor of pharmacy practice at Ferris State University’s College of Pharmacy, says permitting pharmacists to perform certain services usually performed by primary care physicians can lower costs.
“Ideally, the most cost-effective use for delivery of care is for the ability to have a collaborative practice agreement executed that allows the pharmacist then to evaluate a patient, conduct [waived] tests, and dispense an antibiotic, if necessary,” said Klepser.
In most states, collaborative practice agreements (CPAs) define the formal working relationships among pharmacists and physicians. A CPA allows a pharmacist to provide specific primary care functions independent of a primary care provider in certain circumstances, according to the American Pharmacists Association’s website.
Most pharmacies can take on CLIA-waived testing without straining their workforce, Klepser says.
“Pharmacies are well-equipped to absorb this type of workflow,” Klepser said. “We found that the workflow with these models does not add significant interruption to a pharmacist’s workload. It is very similar to a pharmacist administering vaccinations—roughly five minutes of the pharmacist’s time or less.”
Patients Express Satisfaction
More than nine out of 10 patients who undergo CLIA-waived testing at pharmacies approve of the care they receive, Klepser says.
“We have found that patient satisfaction with these types of pharmacy-based services is incredibly high,” Klepser said. “Roughly, 90–92 percent of the patients are satisfied with the care provided to them.”
Michael McGrady ([email protected]) writes from Colorado Springs, Colorado.
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