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:
- Investigations and enforcement actions have revealed that HCPs often “receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend.” According to HHS-OIG, “[s]uch cases strongly suggest that one purpose of the remuneration to the HCP speaker and attendees is to induce or reward referrals.”
- “[S]tudies have shown that HCPs who receive remuneration from a company are more likely to prescribe or order that company’s products. This remuneration to HCPs may skew their clinical decision making in favor of their own and the company’s financial interests, rather than the patient’s best interests.”
- “There are many other ways for HCPs to obtain information about drug and device products and disease states that do not involve remuneration to HCPs. HCPs can access the same or similar information provided in a speaker program using various online resources, the product’s package insert, third-party educational conferences, medical journals, and more.” According to HHS-OIG, “[t]he availability of this information through means that do not involve remuneration to HCPs further suggests that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals.”
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:
- “The company sponsors speaker programs where little or no substantive information is actually presented.”
- “Alcohol is available or a meal exceeding modest value is provided to the attendees of the program (the concern is heightened when the alcohol is free).”
- “The program is held at a location that is not conducive to the exchange of educational information (e.g., restaurants or entertainment or sports venues).”
- “The company sponsors a large number of programs on the same or substantially the same topic or product, especially in situations involving no recent substantive change in relevant information.”
- “There has been a significant period of time with no new medical or scientific information nor a new FDA-approved or cleared indication for the product.”
- “HCPs attend programs on the same or substantially the same topics more than once (as either a repeat attendee or as an attendee after being a speaker on the same or substantially the same topic).”
- “Attendees include individuals who don’t have a legitimate business reason to attend the program, including, for example, friends, significant others, or family members of the speaker or HCP attendee; employees or medical professionals who are members of the speaker’s own medical practice; staff of facilities for which the speaker is a medical director; and other individuals with no use for the information.”
- “The company’s sales or marketing business units influence the selection of speakers or the company selects HCP speakers or attendees based on past or expected revenue that the speakers or attendees have or will generate by prescribing or ordering the company’s product(s) (e.g., a return on investment analysis is considered in identifying participants).”
- “The company pays HCP speakers more than fair market value for the speaking service or pays compensation that takes into account the volume or value of past business generated or potential future business generated by the HCPs.”
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.