Last month, we had an engaging Fast Break session covering compliance topics regarding healthcare professionals' relationships with pharmaceutical and medical device manufacturers. We were joined by Terrence Burek, senior counsel, neurology & immunology at EMD Serono, and Morgan Lewis partner Scott Memmott, who highlighted specific compliance risk areas for healthcare professionals (HCPs), as well as permissible interactions with pharmaceutical and medical device manufacturers and contracting/risk mitigation best practices.
If you were still recovering from the Thanksgiving holiday and weren't able to catch the live program, we have you covered with some key takeaways.
Our speakers provided an initial overview of the legal sources from which these compliance risk areas are derived, including the Anti-Kickback Statute; the False Claims Act; the Federal Food, Drug, and Cosmetic Act; the Physician Payments Sunshine Act; and state law transparency reporting, gift ban, and other compliance requirements. For further discussion of these risk areas, view our program.
Although these compliance risks exist, there are still a number of ways that industry and HCPs can interact appropriately as long as the proper safeguards are maintained. The program highlighted various generally acceptable lower risk interactions that were categorized into three general types: medical and scientific, training and education, and commercial. The presenters also discussed potentially problematic interactions.
As these interactions continue to come under government scrutiny, the presenters reflected on the current enforcement environment in light of the US Department of Health and Human Services, Office of Inspector General's Special Fraud Alert (SFA) on speaker programs, recent amendments to the Pharmaceutical Research and Manufacturers of America's (PhRMA) Code on Interactions with Health Care Professionals that become effective the first of the year, and recent enforcement actions that immediately preceded the SFA and directly implicated HCPs. There is not any evidence yet that initial speculation about the SFA leading to a government "crackdown" was accurate, but we probably won't know the actual impact of the SFA for a couple of years as what is in the pipeline works its way through the process.
Lastly, Terrence provided an in-house counsel perspective on best practices for contracting and risk mitigation. For these tips and to replay the webinar in full, check out our program on demand.
Don't forget you can view any of our previous webinars on our Fast Break series page >>
This article is provided as a general informational service and it should not be construed as imparting legal advice on any specific matter.