A special fraud alert from a government watchdog warning companies of red flags to avoid when soliciting doctors as speakers has caused quite a stir in the medical technology industry, in particular a new guide on the alcohol served at events.
The November 2020 alert from the Office of the Inspector General addresses “suspicious circumstances” that medical technologies and drug manufacturers could avoid staying on the right side of compliance and avoid violating the Anti-Bribery Statute. The alert notes that many cases involving industry and physicians occur in settings “not conducive to learning,” such as high-end restaurants, bars and sports venues, including fisheries and wineries.
“The OIG is skeptical of the educational value of such programs,” the alert states.
In addition to suspicious circumstances warning of alcohol at events, alert notes invite the same speakers on the same topic multiple times and if the company sponsors a large number of programs on the same topic.
“The fraud special alert has caused quite a stir in the industry over the past year,” said Sarah Cummings, an attorney representing medical technologies in fraud cases at Reed Smith, during a session at AdvaMed’s annual conference.
First on his list to argue with Ben Wallfisch, senior attorney for the Industry Guidance Branch of the Inspector General’s Office of Legal Counsel with HHS, was alcohol.
“Alcohol is available or a meal exceeding the modest value is provided to program attendees (concern increases when alcohol is free),” the guide reads.
Drug and device manufacturers have spent $ 2 billion in the past three years on such events, according to the OIG. Companies are required since 2013 to disclose payments to doctors and health systems, which are made public annually.
“How much is too much? Does the OIG really expect companies to phase out all alcohol? Are companies really expected to ban alcohol?” Cummings asked.
Wallfisch said companies set the tone for such events and should think about where an event will be located: a bar, a high-end restaurant, or something more like a classroom.
“I think it’s fair to ask which one is more like an educational event rather than which one is more like an entertainment event,” Wallfisch noted.
The discussion of the Public Health Emergency context also emerged, since the alert was issued in the midst of the pandemic. Cummings asked if there is an implicit push towards virtual events by the OIG, noting that medical technology could be viewed differently than pharmaceutical with physical products involved.
“We think virtual shows are probably less risky from a compliance perspective,” Wallfisch said, noting that food, alcohol and an expensive venue would be removed from the table.
As for what companies should do in response to the alert, Wallfisch noted that some trade groups have revised their codes of ethics, including the Phrma pharmaceutical lobby.
“This is an opportunity to look closely and see if it’s worth it. The document may indicate that some types of practices are too risky,” Wallfisch said.
AdvaMed’s code of ethics is dated May and does not explicitly mention alcohol.