Financial Compliance in Clinical Trials

Financial compliance considerations are an important aspect of the design and funding of clinical trials. Such research often involves a mixture of sponsor funding and insurance billing for the clinical services provided in the trial. In the United States, what can be billed to insurance and what must be paid by a sponsor are in general determined by the Centers for Medicare & Medicaid Services (CMS). Other third-party payer policies largely mimic those of CMS. Medicare reimbursement for clinical trials is determined by the interagency agreement between the Food and Drug Administration and CMS regarding investigational devices, the clinical trials policy, and CMS guidance on coverage with evidence development. Non-compliance in research billing carries risk of monetary penalty. To ensure compliance, providers and institutions must conduct coverage analyses to determine if a trial qualifies for CMS coverage and, if it does, which clinical items and services can be billed to CMS. Claims with items and services being billed to CMS must be identified with research codes and modifiers. While these policies and procedures have brought some clarity to research billing, there are still murky waters that providers and institutions need to navigate. The risk from non-compliance is not theoretical. Several cases of large fines to major research institutions have been well publicized. The imperative for having a comprehensive program for billing compliance continues to mount, and the cost of this necessary infrastructure must be part of the calculation of institutional overhead for clinical research.