Part 2: Impact of Fraud and Abuse Laws on Clinical Research

The second part of the meeting will address the effect on clinical research of fraud and abuse laws, including the Anti-Kickback Statute and the Beneficiary Inducement provisions of the Civil Monetary Penalty Law, as well as their state law counterparts. Briefly stated, fraud and abuse laws place limitations on remuneration provided to health care providers and patients to prevent third-party payors of healthcare services from paying for medically unnecessary or excessive services and to prevent patients from being induced to select a particular healthcare provider. While these laws are not explicitly directed towards the research environment, they have major implications for clinical research conducted in the United States, affecting practices ranging from research sponsors paying for copayments or deductibles associated with standard of care services required under a clinical trial protocol, to payments from life sciences companies to physicians to collect data for registry studies, to the provision of “smart devices” to patients as part of a research study.

Attendees learned about the impact of fraud and abuse laws on clinical research, overviewing research situations that may violate these laws and discussing how these laws relate to recruitment, compensation, and financial aid for research participants.

Deliverables