The Department of Health and Human Services (HHS) released a Special Fraud Alert from the Office of Inspector General (OIG) highlighting the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration related to speaker programs sponsored by healthcare companies.
The OIG and Department of Justice (DOJ) have investigated numerous fraud cases involving allegations that compensation offered and paid in connection with speaker programs violated the anti-kickback statute, and the Federal government has pursued civil and criminal cases against pharmaceutical and medical device companies and individual health care professionals (HCPs) involving these speaker programs.
Congress enacted the anti-kickback statute, in part, to protect patients from referrals or recommendations by HCPs who may be influenced by inappropriate financial incentives. Individuals and companies violate the statute when compensation purposefully induces or rewards the referral of items or services payable by a Federal health care program.
While healthcare company-sponsored speaking events were created with the purpose of educating listeners regarding the use or value of a company's medical devices or medications, OIG revealed that often, "HCPs receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend." These cases "strongly suggest that one purpose of the remuneration to the HCP speaker and attendees is to induce or reward referrals."
These speaking events are significant investments for the companies involved and that many providers have earned significant amounts from appearing at these events. OIG reported that drug and device companies have reported paying nearly $2 billion to HCPs for speaker-related services over the last three years.
OIG also notes that the information shared at speaking events can be found via other sources, such as online resources, information in a product's packaging, third-party educational resources, medical journals and more.
As a result of the inherent risk in using speaking events to share information, these events may be subject to increased scrutiny.
Below is a selection of the characteristics OIG provided in its Alert to provide an illustrative, though not exhaustive, list of features that indicate a speaker program arrangement could potentially violate the anti-kickback statute.
- 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;
- The company pays HCP 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 HCPs.
Ultimately, OIG suggests that companies should assess the need for in-person programs, particularly given the risks associated with offering or paying related compensation, and consider alternative, less-risky means for conveying information.
While the pandemic has effectively curtailed many in-person events for the time being, OIG says it makes this a good time for providers to review past activities and establish stronger policies and guidelines for participation in future events, or to establish a policy against participating in such events
If you have questions about a specific speaker program arrangement involving remuneration to referral sources, the OIG Advisory Opinion process remains available.