On November 16, 2020, the HHS Office of Inspector General (“OIG”) issued a special fraud alert regarding “the offer, payment, solicitation, or receipt of remuneration” relating to speaker programs for pharmaceutical and medical device companies.
The targeted speaking engagements involve programs presented by physicians or other healthcare provider, who are not employed by the company, and the programs are prepared or approved by the drug or device company.
The OIG is warning that all parties involved speaking programs will be subject to increased scrutiny for potential Anti-Kickback Statute (“AKS”) violations, including:
- Any drug or device company that organizes or pays remuneration associated with the program
- Any healthcare provider paid to speak
- Any healthcare provider attendee who receives remuneration from the company (including free food and drink).
Based on prior cases and investigations, the OIG expressed skepticism regarding the educational value of the speaking programs, combined with the amount of remuneration provided to the presenter and any attendees. And it is concerned that remuneration may influence a provider to use the product or may be seen as a reward for past use, without regard for the patient’s needs. Thus, any criteria for the remuneration or the award of the speaking engagement that could be seen as being tied to usage of the company’s product is being closely monitored for potential AKS violations.
The OIG provided an illustrative, non-exhaustive list of characteristics of a speaking program that would raise suspicion:
- “The company sponsors speaker programs where little or no substantive information is actually presented;”
- “Alcohol is available or a meal exceeding modest value is provided to the attendees of the program (the concern is heightened when the alcohol is free);”
- “The program is held at a location that is not conducive to the exchange of educational information (e.g., restaurants or entertainment or sports venues);”
- “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;”
- “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;”
- “[Health care providers] 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 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 [health care provider] 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;”
- “The company’s sales or marketing business units influence the selection of speakers or the company selects [health care provider] 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);”
- “The company pays [health care provider] speakers more than fair market value for the speaking service or pays compensation that takes into account the volume or value of past business generated or potential future business generated by the [health care providers].”
The OIG has made it clear that it will continue to monitor these speaking programs closely, particularly in light of the fact that the pandemic has shown that in-person programs are not always necessary. Thus, should in-person programs resume at some point, the OIG is warning, drug and device manufacturers, as well as program organizers, presenters and attendees, to assess the risks involved with in-person programs and any related remuneration for presenting or attending.
The full alert can be found here.