In November 2020, the Department of Health and Human Services, Office of Inspector General (HHS-OIG) published a Special Fraud Alert regarding speaker program suspect factors. SFA speaker programs_11.13 v2 (hhs.gov). In the last three years, drug and device companies have reported paying nearly $2 billion to healthcare providers for speaker-related services. Both HHS-OIG and the Department of Justice (DOJ) resolved numerous fraud cases involving allegations that remuneration paid in connection with speaker programs violated the anti-kickback statute (AKS). 42 U.S.C. § 1320a-7b(b)(1)–(2). Such violations of the AKS can result in criminal, civil and administrative sanctions, including exclusion from government healthcare programs.
The alert listed the following non-exhaustive factors that are suspect when drug and device companies host or pay for speaker programs for healthcare providers.
Lack of substantive content. The company sponsors speaker programs where little or no substantive information is presented.
Exorbitant meals and alcohol. Alcohol is available or a meal exceeding modest value is provided to the attendees (the concern is heightened when the alcohol is free).
Program at an entertainment venue or restaurant. The program is held at a location that is not conducive to the exchange of educational information.
Large number of similar programs. The company sponsors many programs on the same or similar topics or product, especially in situations involving no recent substantive change in relevant information.
No new information regarding product. There has been significant time with no new medical or scientific information nor a new FDA-approved or cleared indication for the product.
Attending similar programs. Healthcare providers attend or speak at multiple programs on the same or substantially the same topics.
Attendees include friends, family, employees, and staff. Attendees include individuals who do not have a legitimate business reason to attend the program, including (1) friends or family members of the speaker or attendee; (2) employees or medical professionals who are in the speaker’s own medical practice; (3) staff of facilities for which the speaker is a medical director; and (4) other individuals with no use for the information.
Relationship between attendee/speaker selection and revenue. The company and/or its sales or marketing departments influence the selection of 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 products.
Paid more than fair market value. The company pays speakers more than fair market value for the speaking service or pays compensation that considers the volume or value of past business or potential future business generated by the healthcare providers.
Proactive Measures for Companies and Healthcare Providers
Overall, HHS-OIG has significant concerns about companies paying and healthcare providers receiving remuneration in connection with speaker programs. Companies should assess the need for in-person programs given the risks associated with paying related remuneration and consider alternative less-risky means for conveying information. Healthcare providers should likewise consider the risks of receiving remuneration related to speaker programs given other available means to gather information relevant to providing appropriate treatment for patients. It could be beneficial for companies, speakers and attendees to document both the assessment and necessity of the program.
If healthcare providers are paid speaker fees or attend company sponsored programs, companies and healthcare providers should also contemporaneously document the time attending and preparing for the program, costs including lost revenue, educational value and attendance associated with the same. Companies and healthcare providers who sponsor, speak at or attend such programs should consider consulting with counsel so that the documentation is as robust as possible if there is a future government investigation.