OIG Issues Special Fraud Alert on Speaker Programs

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Earlier this month, the OIG issued a special fraud alert on speaker programs warning drug and device makers and healthcare providers that it had serious concerns about payments for “speaker programs”. Based on recent investigations and enforcement activities, the OIG has found that a number of speaker programs sponsored by drug and device manufacturers violate the federal anti-bounce law ( AKS). The OIG is skeptical of the educational value of speaker programs provided in circumstances that are not conducive to learning and to members of the public who have no legitimate reason to attend. Additionally, the OIG questions the value of such events given that healthcare providers can access the same or similar information online, on the product insert, at third-party educational conferences, medical journals , etc Since all of this material is already available, the OIG warns “that at least one purpose of compensation associated with speaker programs is often to induce or reward referrals” in violation of federal anti-kickback law ( AKS).

The OIG has defined speaker programs as “company-sponsored events at which a [outside] physician or other healthcare professional (collectively, “HCP”) makes a speech or presentation to others [outside] Healthcare Professionals About a Drug or Device or Medical Condition on Behalf of the Company” using a presentation developed and approved by the Company. Medical professionals receive an honorarium, and participants are usually paid in the form of free meals and drinks, for example.

Based on its investigations to date, the OIG has provided an illustrative list of speaker program features that result in a higher level of scrutiny with respect to AKS violations:

  • Little or no substantial information is actually presented by the speaker;
  • Alcohol (especially if free) or a meal of more than modest value is provided;
  • The environment is not conducive to the exchange of educational information (e.g.., restaurants or places of entertainment or sport);
  • A large number of sponsored speaker programs on the same or substantially the same topic or product (particularly if there is no recent substantial change in relevant information or applicable law/regulation) and regular attendees or participants are former lecturers on the same or substantially the same subject;
  • Participants without a legitimate business reason or use of information attend the program;
  • Speakers or HCP attendees selected based on past or expected revenue from prescribing or ordering the company’s product(s) (e.g.., an analysis of the return on investment is taken into account to identify the participants);
  • Fees above fair market value paid for speaker service or compensation that takes into account the volume or value of past business generated or potential future business generated by healthcare professionals.

In light of the COVID-19 pandemic, the OIG recognizes that speaker activity may have slowed. But the OIG fully anticipates that once face-to-face meetings resume in full swing, it will pay attention to any drug or device company that organizes or pays compensation associated with the program, to any HCP that is paid to speak and to all HCP participants who receive company compensation (eg, free food and drink).

The OIG has recognized that manufacturer-sponsored speaker programs are not per se illegal. Still, this alert is a warning to all manufacturers that they should review their speaker programs to ensure they serve a legitimate purpose and avoid the OIG warning zones. This alert is also noteworthy, in that the OIG not only used experience from its enforcement actions to inform this statement, but it also used data from CMS’s Open Payments program which requires the reporting of data on financial relationships between manufacturers and physicians and academic medical centers. It will be interesting to see if the OIG continues to leverage 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 such as durable medical equipment suppliers or laboratories, the same warnings from this fraud alert may apply. Therefore, all vendors should assess their speaker programs to mitigate the risks raised by AKS.

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