The Missing Link: Evaluating Economic Outcomes of an Uncoded Novel Diagnostic from Claims Data

OBJECTIVES: Healthcare claims are often used to assess medical resource utilization (MRU) and costs but are less suited for evaluating novel diagnostics or therapeutics not issued a unique code, limiting payer decision-making on their real-world value. Complicated urinary tract infections (cUTIs) must be diagnosed and treated early and accurately to reduce their risk of poor outcomes. We aimed to develop and evaluate a claims-based method to identify an uncoded rapid novel diagnostic (ND) for mono/polymicrobial pathogens and sensitivities and assessed MRU and cost outcomes of its use compared with standard culture and sensitivities (SC) for cUTI.

METHODS: Using a 5% 2017-2019 Medicare Limited Dataset, we algorithmically identified Parts A+B beneficiaries with cUTI; identified the specific rapid ND from billed codes, laboratory identifiers and test date; and compared UTI-related MRU and cost for propensity-matched cUTI cohorts whose outpatient UTIs were diagnosed entirely with ND versus with SC for one year following a baseline year.

RESULTS: About 11% of ~1.5M beneficiaries in each year had claims with principal or secondary diagnosis of UTI. 3184 ND tests were identified, representing 0.40% of all UTI tests. Adjusting for sample size, this represented 110% of the laboratories’ reported volume on the diagnostic. 69 ND and 678 SC individuals were propensity-matched. 65.2% of ND and 72.0% of SC had >1 additional UTI in the year (p=0.24). Rates of a UTI-related MRU composite (urgent care, emergency, inpatient, skilled nursing) were 115.9 and 199.1 events per 1000 patient-years for ND and SC (p=0.168) and mean allowed total UTI costs (excluding ND and SC) were $629.55 (95%CI: 430.27, 920.90) versus $1,131.39 (1002.16, 1,277.27) (p=0.004). Subgroup analyses suggested greatest benefit for diabetics (p=.012)..

CONCLUSIONS: We demonstrated a claims-based method to identify a novel uncoded diagnostic and found a significant cost benefit compared with the standard diagnostic for patients with cUTIs.