The United States Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a “Special Fraud Alert: Speaker Programs,” that highlights some of the fraud and abuse risks associated with speaker programs typically run by pharmaceutical and medical device companies.
Issues with Speaker Programs
The Fraud Alert states that based on Open Payments data, pharmaceutical and device companies have paid nearly $2 billion to healthcare professionals for speaker-related services. The Fraud Alert cites the PhRMA Code on Interactions with Health Care Professionals, which states that health care professionals “participate in company-sponsored speaker programs in order to help educate and inform other health care professionals about the benefits, risks, and appropriate uses of company medicines,” but indicates that OIG is skeptical about the educational value of such programs, believing that “one purpose of the remuneration to the HCP speaker and attendees is to induce or reward referrals” and that “studies have shown that HCPs who receive remuneration from a company are more likely to prescribe or order that company’s products.”
OIG believes that there are “many other ways for HCPs to obtain information about drug and device products and disease states that do not involve remuneration to HCPs” and therefore, the availability of information in ways that do not involve remuneration to HCPs “further suggests that at least one purpose of remuneration associated with speaker programs is often to induce or reward referrals.”
Suspect Characteristics, According to HHS-OIG
At the close of the Fraud Alert, HHS-OIG does recognize that there are lawful reasons for some remunerative arrangements, and the lawfulness depends on the specific facts and circumstances, including the intent of the parties. HHS-OIG goes on to note that the parties’ intent can be determined by looking at the characteristics of the speaker program and the actual conduct of the parties involved.
Below is a list of some characteristics – taken separately or together – which may indicate a speaker program that is in violation of the Anti-Kickback Statute. Note that the below list is not the entire list from the Fraud Alert, and even the entire list from the Fraud Alert is not exhaustive. The presence or absence of any of the below factors is not determinative by itself whether a particular arrangement would be considered suspect by HHS-OIG.
- The company sponsors speaker programs where little or no substantive information is actually presented;
- Alcohol is available or a meal that exceeds “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;
- HCPs 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).
Continue Speaker Programs at Your Own Risk
In the Fraud Alert, HHS-OIG explicitly noted that, “[p]arties involved in speaker programs may be subject to increased scrutiny,” including “any drug or device company that organizes or pays remuneration associated with the program, any HCP who is paid to speak, and any HCP attendees who receive remuneration from the company” – including those who only attend and receive free food and/or drink.
We have written many times, both on this site and in our sister publication Policy & Medicine Compliance Update, about myriad settlements that involve speaker programs. This Fraud Alert should, at a bare minimum, show compliance departments the seriousness and importance of having strict guidelines on venues and attendance at any speaker events. Given the seriousness with which HHS-OIG and other government agencies focus on speaker events, it may be more prudent at this stage for manufacturers to refocus financial support to the activities outlined as alternatives in the report including: “various online resources, the product’s package insert, third-party educational conferences, medical journals, and more.”