On November 16, 2020, the U.S. Health & Human Services (HHS) Office of Inspector General (OIG) issued a rare Special Fraud Alert – a type of guidance historically used to signal enforcement priorities – “to highlight certain inherent risks” of remuneration related to speaker programs sponsored by drug and device companies. OIG states that it “is skeptical about the educational value of such programs” and that companies should “consider alternative less-risky means for conveying information” to health care professionals (HCPs). While the OIG’s position is not surprising in light of the increase in speaker program-related settlements with drug and device manufacturers over the past five years, several of which have resulted in restrictions as well as outright prohibitions on speaker program activity, the Special Fraud Alert marks the OIG’s clearest signal to date that speaker programs will be subject to continuing, and potentially heightened, enforcement scrutiny.

Speaker programs typically involve an HCP who is not an employee of the company speaking in person to other HCPs about a company product or disease state using a presentation developed and approved by the company. OIG expresses “significant concerns” that companies organize and pay for such programs with the intent to induce HCPs to prescribe, order, or recommend the prescription or ordering of the companies’ products, in violation of the federal anti-kickback statute.^[1] OIG states that any party involved in speaker programs may be subject to increased scrutiny, including the drug or device company that organizes the program, any HCP who is paid to speak, and any HCP attendees who receive remuneration from the company (e.g., free food and drink).

OIG advises drug and device companies and HCPs to consider the inherent risks of speaker programs as they evaluate whether and how to resume in-person speaker programs that have been curtailed during the COVID-19 pandemic. To guide this decision, OIG provides a list of factors that would render a speaker program suspect, and which, when combined with the requisite intent, could create potential liability under the anti-kickback statute. These factors, while generally reflective of industry best practices, include a few new or more explicitly stated restrictions^{[2], [3]} and emphasize the importance of robust controls and oversight for companies who choose to continue to offer in-person speaker programs.

• No substantive content presented. The company sponsors speaker programs where little or no substantive information is actually presented;
• Any alcohol or excessive value of food available. A meal exceeding modest value is provided to the attendees of the program or alcohol is made available (this concern is further heightened when the alcohol is free);
• No restaurants or entertainment venues. The program is held at a location that is not conducive to the exchange of educational information (e.g., certain restaurants or entertainment or sports venues);
• Number of programs, repeat topics. 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;
• No new or recent information imparted. 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;
• Repeat attendees. 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 without legitimate business interest. 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;
• Sales or marketing influence on speaker selection. 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);
• Excessive speaker compensation. The company pays HCP speakers more than fair market value for the speaking service (with the example of some speakers compensated hundreds of thousands of dollars) or pays compensation that takes into account the volume or value of past business generated or potential future business generated by the HCPs.

The Special Fraud Alert noted a suspicion about the educational value of speaker programs, in general. OIG rounds out this skepticism with examples of non-remunerative avenues to convey the same information, such as online resources, third-party educational conferences, product packaging, and medical journals. Given the OIG’s identification of various “less risky” alternative means for conveying information to HCPs, it remains to be seen what role in-person speaker programs will play in the future. However, in light of the heightened scrutiny OIG signals in this Special Fraud Alert, drug and device companies should ensure that appropriate safeguards are in place to protect against any of the suspect characteristics identified by OIG.

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