Laboratory and clinical data integration: Toward an evidence development framework.

Abstract

e18318 Background: Decision making in precision oncology relies on the timeliness of diagnostic testing. Uncertainty surrounding the clinical utility of laboratory developed molecular and next generation sequencing (NGS) tests (LDTs) has engendered a predominantly manual claims review process. Denials and delays may create hurdles for optimally treating patients, and denials may contribute to financial toxicity. ASCO’s CancerLinQ aggregates clinical data from EHRs of participating oncology practices to improve the quality of care for patients. We hypothesized that standardized clinical data could be used in the short term to appeal denials of NGS LDTs and in the long run, lead to evidence-based coverage decisions. Methods: Using National Provider Index IDs, CancerLinQ participating physicians were cross-walked to ordering physicians of tests offered from 100 U.S. laboratories using XIFIN for billing services in 2018 to evaluate the feasibility of using CancerLinQ clinical data for claims adjudication. We determined the proportion of molecular and NGS tests (based on CPT coding) initially denied and the proportion of successful appeals through a manual submission process for clinical documentation (not including CancerLinQ data). CancerLinQ clinical data were evaluated for key elements necessary for successful appeals. Results: Sixty-five percent of CancerLinQ participating physicians ordered tests from the laboratories identified. Approximately 80% of NGS and 40% of molecular services were initially denied. After appealing with clinical information through the manual process, 55% of denials were successfully overturned. Key clinical data provided manually could be automatically extracted from CancerLinQ at high rates, such as ICD-9/ICD-10 cancer diagnosis (100% of 1,082,606 patients), Stage Group (47.6 %), and treatment plan (35.9%). Metastatic disease status is available through M1-stage (23.2% of total M-Stage), AJCC Stage IV (29.0% of total AJCC Stage) and Metastatic diagnosis codes (17.2%). Conclusions: CancerLinQ contains key data elements necessary for successful appeals and can streamline the claims adjudication process, ultimately helping to build the evidence base for coverage decisions.