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LUGPA Research Team's Groundbreaking New Publication on PCR in UTI Evaluation

Oct. 2, 2023 

Dear LUGPA Members,

Since the sudden announcement by MolDx of new guidelines pertaining to PCR reimbursement, LUGPA has been intensively involved in the effort to define, explicate, and support the role of this modality in clinical GU practice. The new guidelines, which limited patient access to this diagnostic tool, were implemented without notification or input by critical stakeholders and could dramatically impact urological practices nationwide.

LUGPA has been involved in several studies to establish and highlight the real-life practical application of PCR urine testing, lending both support and research to these efforts. In collaboration with P4Diagnostics, the health policy and research team are pleased to announce the publication of “The Essential Role of PCR Panel Size in Comparison with Urine Culture in Identification of Polymicrobial and Fastidious Organisms in Patients with Complicated Urinary Tract Infections,” a recently published article in the International Journal of Molecular Science. The new article can be found here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10531650/.

Key findings of this study include:

  • PCR demonstrated a significantly higher rate of pathogen and polymicrobial UTI/Fastidious organism detection compared to urine culture, indicating its superior sensitivity in identifying microbial pathogens in the recurrent UTI patient population.
  • PCR revealed pathogens in 35% of cases where UC yielded negative results, highlighting enhanced detection.

These findings have important implications for diagnosing and treating recurrent UTI patients, highlighting the potential of improving clinical outcomes for this subset of individuals by providing complementary data provided by both UC and PCR, which can guide clinicians in making more informed decisions regarding patient care.

BACKGROUND:

Regarding urinary NAATs, while MolDx technically permits their use, it has rejected technical assessments and supporting literature provided by providers. This program governs coverage and reimbursement for molecular diagnostic tests in its MAC regions, such that many member practices faced challenges in navigating the MolDx registration process for PCR tests.

  1. LCD L39001: Covers "Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing." This LCD provides limited coverage for outpatient testing with molecular syndromic panels.

LUGPA has taken proactive steps to assist its member practices in understanding the MolDx registration process for PCR tests; our webinars on the program and its guidelines are available on our website here.

LUGPA Health Policy team will continue to post updates and information as it becomes available on the website: https://www.lugpa.org/policy-advocacy.