Clinical Research Billing: EHR Optimization Recommendations for Non-Academic Medical Practices

Physicians employed in a variety of academic and non-academic medical environments conduct clinical research studies to benefit their patients, engage in scientific advancement, gain professional and personal satisfaction, and obtain financial benefit.  Within the past few decades, the United States government has developed and applied a variety of regulations related to billing for clinical research services, which may be unfamiliar to medical practice operations professionals.  In parallel, most practices have adopted complex electronic health record (EHR) systems, and practice teams must fully leverage those systems to ensure maximal operational efficiency and full compliance with clinical research revenue cycle regulations.  Every practice that performs clinical research must engage a multidisciplinary team to master the associated billing rules and regulations, including the three different classifications applicable to charges that can be generated for research participants, and effectively translate those rules into their EHR-specific workflows.  Such a coordinated effort will maximize practice efficiencies, ensure billing accuracy, and encourage continued involvement in clinical research participation.