Healthcare Speaker Programs and AKS Compliance: Regulatory Update, Lessons Learned From Recent Settlements

Of Counsel, Rachel Yount will be speaking on the panel for the Strafford webinar, "Healthcare Speaker Programs and AKS Compliance: Regulatory Update, Lessons Learned From Recent Settlements." 

Description:

The pharmaceutical and medical device industries have long used speaker programs to educate healthcare professionals on the uses of company products and emerging developments. However, the government continues to increase scrutiny of these programs, looking for potential AKS noncompliance and imposing severe penalties for violations.

The AKS prohibits offering or paying anything of value to induce the referral of items or services covered by Medicare, Medicaid, and other federal programs so that medical providers' judgments are not compromised by improper financial incentives. HHS-OIG issued a special fraud alert related to these programs and the inherent abuse risks where the agency found that participating healthcare providers often receive generous compensation to speak at programs that "are not conducive to learning or to speak to audience members who have no legitimate reason to attend" thereby suggesting that the purpose of the remuneration to the speakers and attendees is to induce or reward referrals in violation of the AKS.

Subsequent to HHS-OIG's fraud alert, the Pharmaceutical Research and Manufacturers of America (PhRMA), updated its Code on Interactions with Health Care Professionals with guidance on speaker program conduct that is less likely to violate the AKS.

However, despite this guidance, companies continue to offer speaker programs that violate the AKS and have been subject to severe penalties as demonstrated by recent settlements such as the $202 million Gilead Sciences Inc. settlement to resolve claims that it used speaker programs to induce physicians to prescribe its HIV drugs. Or the $3.6 million Assertio Therapeutics Inc. settlement to resolve similar allegations related to its fentanyl product.

Listen as our expert panel takes a closer look at the use of speaker programs in the healthcare industry and the history of government scrutiny and guidance. The panel will examine notable recent settlements related to speaker programs and discuss lessons learned. The panel will also offer best practices for developing compliant speaker programs and minimizing the risk of enforcement action.