Earlier this month, OIG issued a Special Fraud Alert on Speaker Programs warning drug and device companies and health care providers that it has significant concerns about payments for “speaker programs.” Based on recent investigations and enforcement activity, the OIG has found that a number of speaker programs sponsored by drug and device manufacturers violate the federal Anti-Kickback Statute (AKS). OIG is skeptical about the educational value of speaker programs provided under circumstances that are not conducive to learning and to audience members who have no legitimate reason to attend. Additionally, OIG questions the value of such events given that health care providers can access the same or similar information online, on the product’s package insert, third-party educational conferences, medical journals, and more. Because all of this material is already available, OIG warns “that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals” in violation of the federal Anti-Kickback Statute (AKS).
OIG defined speaker programs as drug or device “company-sponsored events at which a [outside] physician or other health care professional (collectively, “HCP”) makes a speech or presentation to other [outside] HCPs about a drug or device product or a disease state on behalf of the company” using a presentation developed and approved by the company. HCPs are paid an honorarium and attendees are paid generally through free meals and drinks, for example.
Based on its investigations to date, OIG provided an illustrative list of speaker program characteristics that result in higher level of scrutiny with respect to AKS violations:
- Little or no substantive information is actually presented by the speaker;
- Alcohol (especially if for free) or a meal exceeding modest value is provided;
- Environment is not conducive to the exchange of educational information (e.g., restaurants or entertainment or sports venues);
- Large number of speaker programs sponsored on the same or substantially the same topic or product (especially if no recent substantive change in relevant information or applicable law/regulation) and repeat attendees or attendees are past speaker on the same or substantially the same topic;
- Attendees without a legitimate business reason or use for the information attend the program;
- HCP speakers or attendees selected based on past or on expected revenue from prescribing or ordering the company’s product(s) (e.g., a return on investment analysis is considered in identifying participants);
- Higher than fair market value honorarium paid for the speaking service or compensation that takes into account the volume or value of past business generated or potential future business generated by the HCPs.
In light of the COVID-19 pandemic, OIG recognizes that the speaker activity may have slowed. But OIG fully anticipates that once in person meetings are back in full swing, it will be paying attention to any drug or device company that organizes or pays remuneration associated with 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).
The OIG acknowledged that speaker programs sponsored by manufacturers are not per se illegal. Yet, this alert is a warning to all manufacturers that they should scrutinize their speaker programs to ensure that they serve a legitimate purpose and avoid the areas of warning from the OIG. This Alert is also notable, in that the OIG not only used experience from their enforcement actions to inform this statement, they also used data from CMS’s Open Payments program that requires reporting of financial relationship data between manufacturers and physicians and academic medical centers. It will be interesting to see if the OIG continues to mine this financial data to provide additional alerts in the future. Finally, while the OIG has not focused on speaker programs sponsored by other healthcare providers like durable medical equipment suppliers or laboratories, the same warnings in this fraud alert can apply. Therefore, all providers should evaluate their speaker programs to mitigate risks that are raised under the AKS.