Effective Corporate Compliance: Pharmaceutical Speaker Arrangements with Physicians Continue to Pose Significant Challenges
This Briefing is brought to you by AHLA’s Fraud and Abuse Practice Group.
- April 11, 2023
- Asha Scielzo , American University Washington College of Law
- Rachel M. Fleischer , American University Washington College of Law
- Maria F. Martinez , American University Washington College of Law
The U.S. Department of Justice (DOJ) and the Department of Health and Human Services Office of Inspector General (OIG) have long expressed concern about fraud and abuse risks posed by the pharmaceutical industry’s relationships with health care professionals. Arrangements between pharmaceutical companies and physicians who speak or present about drug products have been the focus of particular attention from government regulators and continue to present significant compliance challenges. Notably, in September 2022, pharmaceutical company Biogen Inc. agreed to a $900 million settlement to resolve allegations that it caused the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians, including through speaker programs, to induce them to prescribe its drugs. In order to achieve effective corporate compliance, the OIG strongly recommends that pharmaceutical companies consider speaker arrangements with physicians to be an area of high risk warranting close review prior to implementation and ongoing scrutiny while in place. This article summarizes pertinent aspects of the Biogen settlement along with key OIG and industry guidance and offers compliance takeaways for pharmaceutical companies and physicians seeking to minimize fraud and abuse risks arising from speaker programs.
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