There’s no such thing as a free lunch…. This adage is over 50 years old, and the Office of Inspector General for Health & Human Services (OIG) wants to remind doctors that it remains true.
The pharmaceutical and medical device industry continues to woo doctors with invitations to educational speaker programs in high-end restaurants, with golf excursions, or at sporting venues. On Monday, November 16, the OIG issued a new Special Fraud Alert to remind doctors that speaker programs sponsored by pharmaceutical and medical device companies must serve a legitimate educational purpose and must be appropriately tailored to meet a need in the medical community.
The Open Payments Act requires pharmaceutical and medical device companies to report their spending on entertainment. According to Open Payments data, cumulative doctor payments in the three years from 2017-2019 exceeded $2 billion, and the OIG emphasized that this high amount of spending, and its potential to influence the prescribing or ordering habits of targeted physicians, was one of the reasons for this new alert.
The OIG and the US Department of Justice (DOJ) continue to pursue criminal and civil cases against pharmaceutical and medical companies involving improperly structured speaker programs. The OIG and DOJ especially worry about industry efforts to reward high prescribing or ordering doctors with lucrative speaker deals. In some cases, speaking offers have even been conditioned on the doctor meeting certain target thresholds.
So what can a doctor do is asked to speak at this type of event? The doctor should consider the following:
- Why am I being asked to speak at this event?
- Am I an expert in this field with unique knowledge to impart?
- Am I responsible for the content of the presentation?
- Where is the event? What are the optics of its location?
For example, a speaking engagement in a local hospital conference center is much more likely to be viewed as a legitimate event than a meeting room in a four-star resort across the country or in an exotic location. Any event that involves expensive restaurants, alcohol, fishing, or golf is also unlikely to meet the “sniff test.” In fact, the OIG is “skeptical” that these venues and programs contain any legitimate educational content.
The presentation content can also be an area of concern, especially if it is put together by the vendor and contains no new medical information or updates. Other indicators of fraud include invitations to friends and family of the presenter, or compensation exceeding fair market value. According to the OIG, any time a drug or device company engages in “entertainment, recreation, travel, meals or other benefits in association with information or marketing presentations,” such arrangements could implicate the anti-kickback statute. Anti-kickback violations can result in steep penalties, including a maximum fine of $100,000, imprisonment up to ten years, or both. If the violation is severe, the doctor can also be excluded from the Medicare or Medicaid programs.
What many doctors do not realize is that the penalties not only apply to the pharmaceutical or medical device company offering the money, but also to the doctor who receives the offer and accepts payment for the presentation. Penalties could even extend to the doctors attending the events.
When considering a speaking engagement, a doctor should be certain that it serves a legitimate educational purpose and is appropriately tailored to meet a need of the medical community. The event location should be reasonable for the type of education event, and excessive payments beyond a modest honorarium raise concern.
Remember—there is no free lunch!