Unregulated UTI Test Surge Among Older Adults

A recent study published in JAMA Network Open has highlighted a concerning trend regarding the widespread use of unregulated rapid molecular diagnostic tests for urinary tract infections (UTIs) among older adults. The research, conducted by scientists at the Centers for Disease Control and Prevention (CDC), utilized Medicare claims data to analyze the prevalence and implications of these diagnostic tests from 2016 to 2023.

Increase in Unregulated Test Utilization

The analysis revealed a staggering 60-fold increase in the use of multiplex molecular syndromic panels for UTIs over the observed period. The study encompassed more than 36 million older adults, including both community-dwelling individuals and nursing home residents transitioning to health services through Medicare Part A and Part B benefits.

The predominant utilization of these tests, particularly in nursing homes, raises significant concerns regarding appropriate clinical practices. Specifically, the analysis indicated that the proportion of beneficiaries from nursing homes utilizing UTI multiplex tests grew from 1% in 2016 to 12% in 2020.

Cost Implications of Testing

Financially, these multiplex tests are significantly more expensive than traditional urine cultures. For instance, the median cost of a UTI multiplex test claim was approximately $585 in 2023, compared to a mere $8 for a standard urine culture. This discrepancy in costs prompts critical discussions about healthcare resource allocation and prudent spending, particularly in an already financially strained healthcare system.

Concerns about Antibiotic Prescribing

The rise in the use of these unregulated tests for UTI diagnosis carries potential risks, particularly in the context of antibiotic overprescribing. Many older adults receive antibiotics for diagnoses that may be inappropriate, especially in cases of asymptomatic bacteriuria (ASB). The researchers expressed concern regarding the potential for these molecular tests to exacerbate antibiotic misuse, consequently heightening the risk for antibiotic resistance and related adverse effects.

“Clinicians should be aware of the lack of data supporting this testing and the potential to further contribute to inappropriate antibiotic prescribing.” – Study Authors, JAMA Network Open

Regulatory Perspectives and Future Directions

Currently, the Food and Drug Administration (FDA) has not approved any multiplex molecular syndromic panels specifically for UTI diagnosis, though they are employed as laboratory-developed tests in certified labs. This regulatory gap necessitates a careful examination of when and how these tests should be applied in clinical settings.

The authors of the study call for additional monitoring and research to assess the broader implications of multiplex testing for UTI diagnoses, particularly concerning antimicrobial use. They recommend that ongoing dialogues involve medical societies refining clinical guidelines to include the lack of evidential support for these tests.

Given the significant evidence presented in this study, it becomes crucial for health regulators, providers, and researchers to collaborate, ensuring that diagnostic tests meet rigorous standards and deliver value without compromising patient safety. Until further clarity is provided regarding the benefits of multiplex UTI diagnostics, it may be prudent for payment agencies like the Centers for Medicare & Medicaid Services (CMS) to reassess the reimbursement policies for these unregulated tests.

References

[1] Hatfield, K. M., et al. (2024). Use of Multiplex Molecular Panels to Diagnose Urinary Tract Infection in Older Adults. JAMA Network Open.

[2] Fitzpatrick, M. A., et al. (2024). The Proliferation of Multiplex Molecular Testing for Urinary Tract Infections. JAMA Network Open.

[3] Lifespan.io