On November 16, 2020, the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG) published a new Special Fraud Alert on speaker programs sponsored by pharmaceutical and medical device companies. This marks the first Special Fraud Alert issued by the agency in over six years.
The Special Fraud Alert addresses the “inherent” fraud and abuse risks under the Federal health care program anti-kickback statute, 42 U.S.C. § 1320a-7b(b) (Anti-Kickback Statute), associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs. For purposes of the Alert, a “speaker program” is defined as an event sponsored by a pharmaceutical or medical device company at which a physician or other health care professional (HCP) makes a speech or presentation to other HCPs about a drug, device, or disease state on behalf of the company. The company generally pays the HCP speaker an honorarium, and often provides various items of remuneration (e.g., free meals) to program attendees.
In the Special Fraud Alert, HHS-OIG states that, industry claims notwithstanding, it is “skeptical about the educational value of such programs” for the following reasons:
HHS-OIG goes on to provide an “illustrative” list of “suspect characteristics” that, “taken separately or together,” could potentially indicate a speaker program arrangement that could violate the Anti-Kickback Statute. The list includes the following:
HHS-OIG concludes by noting that the COVID-19 public health emergency is “necessarily curtailing many in-person activities,” including in-person speaker programs, and that, going forward, “[c]ompanies should assess the need for in-person programs given the risks associated with offering or paying related remuneration and consider alternative less-risky means for conveying information to HCPs.” HHS-OIG also cautions that “HCPs should likewise consider the risks of soliciting or receiving remuneration related to speaker programs given other available means to gather information relevant to providing appropriate treatment for patients.” In short, the Special Fraud Alert places the industry on notice that those involved in speaker programs — i.e., organizers, sponsors, speakers, and attendees alike — should expect heightened scrutiny on a go-forward basis.