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WHDL - 00015484
Research sites with medical billing practices are at risk for clinical research billing (CRB) non-compliance under the False Claims Act, and violations have serious ramifications. Centers for Medicare and Medicaid Services (CMS) have rules and guidelines regarding billing and claims processing requirements when submitting claims. Financial toxicity impacts patients seeking healthcare services through unexpected financial burdens, distress, or decreased satisfaction. Best practices around processes to justify and document financial responsibility during the study start-up process and then the capture of charges for study-related items and services exist across the industry but often differ across sites. Clinical research and medical billing combined may increase site and participant risk of financial toxicity and CRB non-compliance.