An evaluation of Medicare claims knowledge discovered a 60-fold improve in using unregulated fast molecular diagnostic exams for urinary tract infections (UTIs) in older adults from 2016 to 2023, researchers reported yesterday in JAMA Community Open.
For the examine, researchers with the Facilities for Illness Management and Prevention (CDC) used Facilities for Medicare and Medicaid (CMS) claims knowledge to evaluate the quantity and fee of paid claims for multiplex molecular syndromic panels for UTI amongst older Medicare beneficiaries.
Though urine tradition is the standard take a look at for UTI, multiplex panels produce sooner outcomes, are extra analytically delicate, and may concurrently detect a number of pathogens and a few antibiotic-resistance genes.
Whereas the Meals and Drug Administration has accepted multiplex molecular syndromic panels for bloodstream, respiratory, and different forms of infections, it has not accepted any such take a look at for UTI analysis. Nevertheless, the panels exist as laboratory-developed exams, and so they can be utilized in labs licensed underneath the Medical Laboratory Enchancment Amendments of 1988.
The researchers wished to get a greater understanding of how typically these unregulated exams are getting used, notably in older adults, for whom UTIs are a standard and main purpose for outpatient antibiotic use.
“Multiplex panels for UTIs are of specific curiosity for monitoring, given the big variety of UTIs and the frequency with which antibiotics are given for asymptomatic bacteriuria, which can end in affected person hurt,” the examine authors wrote.
Potential to extend inappropriate antibiotic prescribing
The examine included greater than 36 million older community-dwelling adults and nursing house residents with Medicare Half A and Half B advantages. Over the examine interval, researchers recognized 1,679,328 claims for UTI multiplex testing. The median age of beneficiaries with claims was 77, and 66% of claims had been from feminine beneficiaries.
From 2016 to 2023, the noticed fee of UTI multiplex testing elevated from 2.4 to 148.1 claims per 10,000 fee-for-service beneficiaries yearly. The speed of urine cultures (1,116.2 claims/10,000 fee-for-service beneficiaries yearly) didn’t improve over the identical interval.
The rise in UTI multiplex testing was most pronounced amongst beneficiaries residing in nursing properties, rising from 1% in 2016 to 12% in 2020. Along with laboratories or pathologists, urology was the most typical clinician specialty conducting this testing.
Multiplex panels for UTIs are of specific curiosity for monitoring, given the big variety of UTIs and the frequency with which antibiotics are given for asymptomatic bacteriuria, which can end in affected person hurt.
The examine additionally discovered that the price of UTI multiplex testing was 70 occasions larger than urine cultures, with a median value per declare of $585 in 2023, in contrast with $8 for a urine tradition.
The examine authors say that whereas revolutionary diagnostics are wanted to enhance turnaround occasions and higher differentiate asymptomatic bacteriuria from UTIs, the shortage of specificity in UTI multiplex exams could result in extra antibiotic overprescribing. Moreover, there’s restricted proof demonstrating the good thing about UTI multiplex testing over urine tradition.
“Clinicians ought to pay attention to the shortage of information supporting this testing and the potential to additional contribute to inappropriate antibiotic prescribing,” they wrote. “Extra monitoring and analysis are wanted to find out the results of multiplex testing to diagnose UTI on antimicrobial use and whether or not there are scientific conditions during which this testing could profit sufferers.”
In an accompanying editorial, infectious illness consultants from the College of Colorado Faculty of Drugs and the College of Maryland Faculty of Drugs say the findings elevate considerations that the widespread and unregulated use of those exams will make a nasty state of affairs worse, notably in settings similar to nursing properties, the place there’s restricted antimicrobial stewardship assist.
“Inappropriate therapy of misdiagnosed UTI in sufferers with asymptomatic bacteriuria (ASB) is already a considerable drawback, notably amongst nursing house residents,” Margaret Fitzpatrick, MD, MS, and Daniel Morgan, MD, MS, wrote. “There may be excessive potential for urine molecular exams to extend antibiotic overuse, inflicting elevated antimicrobial resistance, hostile results, and well being care prices.”
They add that till knowledge show the scientific utility of multiplex UTI exams in varied affected person populations and care settings, CMS and different payers ought to take into account not reimbursing for these exams, and medical societies ought to spotlight the shortage of proof in UTI scientific tips.
