NEW YORK – New research suggests there has been a significant rise in the use of expensive multiplex molecular syndromic panels to test for urinary tract infections (UTIs) in elderly individuals in the US, even in the absence of clinical data supporting the routine use of such testing in the clinic.
"Despite a lack of clinical evidence supporting their value, claims for costly multiplex molecular tests for UTIs are frequent among Medicare beneficiaries, including nursing home residents," Kelly Hatfield, an epidemiologist with the US Centers for Disease Control and Prevention's Office of Prevention Research and Evaluation, and Joseph Lutgring, a medical officer with the CDC's epidemiology research and innovations branch, said in an email. "This may contribute to inappropriate antibiotic use."
As they reported in JAMA Network Open on Tuesday, Hatfield, Lutgring, and their colleagues examined Medicare Part A or Part B beneficiary data on related clinician office, laboratory services, or nursing home claims tallied by the Centers for Medicare and Medicaid Services, using these patterns to follow the frequency of unspecified multiplex test use to make primary diagnoses of a UTI between January 2016 and the end of 2023. These tests typically can identify multiple pathogens at once and antimicrobial resistance genes.
"Ensuring that the right test is ordered for the right patient at the right time can limit excessive testing and overdiagnosis, improve antibiotic use, and decrease the risk of adverse events and infection with antimicrobial-resistant organisms," Hatfield, the paper's first author, and senior author Lutgring explained.
Although multiplex molecular syndromic panel tests are used in other clinical settings — from tests for bloodstream or central nervous system infections to tests for respiratory or sexually transmitted infections — the team noted that the US Food and Drug Administration has not yet approved such tests for diagnosing common UTIs, where there is a chance of identifying asymptomatic bacteria or otherwise overprescribing antibiotics.
"There are currently no FDA-approved multiplex molecular syndromic panels to diagnose urinary tract infection (UTI), but such panels exist as laboratory-developed tests (LDTs)," the researchers wrote in the paper, adding that the FDA announced this year plans to increase its regulation of LDTs.
With the help of a computational tool to search for CPT codes linked to UTI fee-for-service coverage between 2016 and 2023, the team tracked down nearly 1.7 million claims linked to multiplex testing for UTIs across the up to 36 million Medicare beneficiaries included in the analysis.
The investigators highlighted a sharp rise in the rate of multiplex testing for UTIs, jumping from just 2.4 claims per 10,000 fee-for-service beneficiaries in 2016 to more than 148 claims per 10,000 by 2023, with nursing home-based beneficiaries making up some 1 percent of those receiving such testing in 2016 and 12 percent by 2020.
That increase was coupled with an uptick in the cost of diagnosing UTIs. An average multiplex test cost $585 in 2023, compared to the $8 to $16 charged for urine culture-based UTI testing the same year.
"We found recent, dramatic increases in the use of multiplex molecular tests for UTI as well as the substantial costs associated with these tests, despite a lack of evidence supporting their value for patient care and the significant potential for inappropriate antibiotic prescribing," the authors reported.
The available data suggested that urology or advance practice clinicians were often among those who referred patients to such testing in the community setting, while nursing home residents more often received referrals from internal medicine or family medicine clinicians. The testing itself was done by several types of specialists, including those working in laboratories, pathologists, and urologists.
"Clinicians should be aware of the limited clinical data supporting this testing and the risk of potentially further contributing to inappropriate antibiotic use," Hatfield and Lutgring noted. "Education about these limitations should occur across healthcare professional specialties."
Further research, the team said, is expected to help in untangling the situations in which multiplex testing may be beneficial and to understand how current multiplex testing patterns influence antimicrobial use in individuals with authentic or suspected UTIs.
More broadly, Hatfield and Lutgring noted that the study underlines research underway at the CDC, including a new framework known as the Core Elements of Hospital Diagnostic Excellence, designed to ensure that the "right tests are ordered, interpreted, communicated, and acted upon appropriately to prevent patient harm."
In a related commentary in JAMA Network Open, Daniel Morgan, with the University of Maryland School of Medicine and Veterans Affairs Maryland Healthcare System, and Rocky Mountain Regional VA Medical Center researcher Margaret Fitzpatrick noted that the new study "provides much needed data to begin addressing the concerning rise in urine multiplex molecular testing."
In particular, Morgan and Fitzpatrick called for further research on everything from sample collection and processing to protocols in the lab and on the reporting front, together with the development of related standards and regulation. On the UTI front, for example, they pointed to research gaps around antibiotic use and antibiotic resistance patterns related to urine molecular testing, as well as a need to clarify when and how multiplex testing may have clinical utility for UTI testing.
"In the absence of such data, we advocate that Medicare and other payors consider not reimbursing for these non-FDA approved and likely harmful tests," Morgan and Fitzpatrick wrote, "and that medical societies highlight the lack of evidence for urine multiplex molecular tests in UTI clinical guidelines."