This Bulletin is brought to you by the Fair Market Value Affinity Group of AHLA’s Hospitals and Health Systems Practice Group.
The Department of Health and Human Services Office of Inspector General (OIG) released a Special Fraud Alert on November 16, 2020 related to the inherent fraud and abuse risk associated with physicians or other health care professionals (HCPs) being offered, solicited, and/or receiving remuneration associated with speaking arrangements on behalf of pharmaceutical and medical device companies.[1] The alert specifically addresses speaking programs where HCPs present or speak about a device, disease state, or a drug and are paid an honorarium or other remuneration by the company. In addition, it focuses on the increased scrutiny associated with these arrangements and how they could potentially violate the Anti-Kickback Statute. Of note, this type of Special Fraud Alert is rare as the last one was issued over six years ago and tackled laboratory payments to referring physicians.[2]
Background
According to the Centers for Medicare & Medicaid Services (CMS), device and drug companies reported paying almost $2 billion to various HCPs in conjunction with speaker-related services.[3] In addition, the alert acknowledges that both the OIG and the Department of Justice (DOJ) have investigated and pursued civil and criminal cases against companies and HCPS with relation to speaker programs. Specifically, the alert cites various alleged cases including:
- selected high-prescribing HCPs to be speakers and rewarded them with lucrative speaker deals (e.g., some HCPs received hundreds of thousands of dollars for speaking);
- conditioned speaker remuneration on sales targets (e.g., required speaker HCPs to write a minimum number of prescriptions in order to receive the speaker honoraria);
- held speaker programs at entertainment venues or during recreational events or otherwise in a manner not conducive to an educational presentation (e.g., wineries, sports stadiums, fishing trips, golf clubs, and adult entertainment facilities);
- held programs at high-end restaurants where expensive meals and alcohol were served (e.g., in one case, the average food and alcohol cost per attendee was over $500); and
- invited an audience of HCP attendees who had previously attended the same program or HCPs’ friends, significant others, or family members who did not have a legitimate business reason to attend the program.[4]
