On November 16, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a Special Fraud Alert (“Alert”) highlighting the fraud and abuse risks associated with speaker programs. The Alert confirms the government’s scrutiny of speaker programs, which it defines as company-sponsored events at which a healthcare professional makes a speech or presentation to other healthcare professions about a drug, device, or a disease state on behalf of the company that provides the speaker remuneration. When remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal healthcare program, the anti-kickback statute is violated. Importantly, remuneration is broadly defined and includes “anything of value, directly or indirectly, overtly or covertly, in cash or in kind.”
Although an unnamed pharmaceutical trade group explained that individuals participate in speaker programs to educate other healthcare professions, the “OIG is skeptical about the educational value of such programs.” The OIG cites multiple studies (including a JAMA article) for the proposition that healthcare professionals that receive remuneration from a company are more likely to prescribe or order that company’s products. The OIG also notes that the availability of information offered in speaker programs (that do not involve remuneration) also suggests that at least one purpose of remuneration associated with speaker programs is to induce or reward referrals.
The OIG provided a list (not exhaustive) of “suspect characteristics” that potentially indicate a speaker program arrangement that could violate the anti-kickback statute.
- The company sponsors speaker programs where little or no substantive information is 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 many programs on the same or substantially the same topic or product, especially in situations involving no recent substantive change in information.
- There has been a significant period 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 without 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 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 considers the volume or value of past business generated or potential future business generated by the HCPs.
The OIG’s Alert provides a clear warning to any healthcare professional engaged in or considering engaging speaker programs. “Parties involved in speaker programs may be subject to increased scrutiny.” If the requisite intent is present, the OIG warned that the company and the healthcare professional “may be subject to criminal, civil, and administrative enforcement actions” for improper speaker program arrangements, according to Alert. Not mentioned in the Alert, but of equal concern, are state anti-kickback and false claims act laws that often closely mirror federal counterparts. In some circumstances, violating the federal anti-kickback statute or the False Claims Act could also create state culpability exposure.
The OIG’s Alert and warnings of increased scrutiny should not be considered idle warnings. Chilivis Grubman attorneys have written extensively about enforcement actions related to speaker programs, speaker fees, consulting fees, and related activities. In July 2020, Chilivis Grubman attorneys wrote about False Claims Act settlements totaling $729 million for alleged kickbacks paid to doctors under the guise of speaker programs. Chilivis Grubman attorneys also wrote about an $18 million False Claims Act settlement related to speaker programs.
The attorneys at Chilivis Grubman – which include a former federal prosecutor – represent clients of all types and sizes in connection with government investigations, both criminal and civil, and False Claims Act litigation. If you need assistance with such a matter, please contact us today.