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. 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,  and emphasize the importance of robust controls and oversight for companies who choose to continue to offer in-person speaker programs.
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.
 Office of Inspector General, Special Fraud Alert: Speaker Programs (Nov. 16, 2020), https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/SpecialFraudAlertSpeakerPrograms.pdf.
 See, e.g., Novartis Corporation Corporate Integrity Agreement (June 30, 2020), https://oig.hhs.gov/fraud/cia/agreements/Novartis_Corporation_06302020.pdf.
 See, e.g., Insys Therapeutics, Inc. Corporate Integrity Agreement (June 5, 2019), https://oig.hhs.gov/fraud/cia/agreements/Insys_Therapeutics_Inc_06052019.pdf