The explosive rise in clinical trial and other clinical research activities at hospitals and academic medical centers across the United States has been accompanied by increased risk of noncompliance and greater opportunity for financial hazard and reward. The federal government's recent changes regarding Medicare billing of clinical research services and the subsequent focus on the billing of patient care services has complicated the clinical research regulatory environment. The research enterprise within a hospital or physician group only achieves financial success by implementing policies and procedures to control and coordinate billing to sponsors and payors.
Effective billing practices begin with the creation of a complete budget and continue with the establishment of internal controls for trial enrollment, billing procedures, audit mechanisms and quality control processes. Our discussion will explore the details within each element and illustrate current examples of best practices in clinical research.