Earlier this week, the Office of Inspector General OIG issued a Special Fraud Alert (Alert) on speaker programs by pharmaceutical and medical device companies in connection with the Federal Anti-Kickback Statute. In the Alert, the “speaker programs” are defined as company-sponsored events at which a health care professional makes a speech or presentation to other health care professionals about a drug or device product or a disease state on behalf of the company. In these scenarios, the company generally pays the health care professional speaker and provides remuneration (such as free meals) to the attendees. In the last three years, drug and device companies have reported paying nearly $2 billion to health care providers for speaker-related services.
In the Alert, the OIG highlighted it is skeptical of the educational value and intent of these speaker programs when there are numerous other ways for health care professionals to obtain information about products and disease states that do not involve remuneration, such as online resources, package inserts, third party educational conferences and journals.
The Alert also provided a number of factors that could evidence improper intent, including, but not limited to:
- 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 professionals 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 professional 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 professional 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 professional 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 professionals.
In the conclusion of the Alert, the OIG reasoned the Alert is not intended to discourage meaningful health care provider education, but rather to highlight certain inherent risks.
As a result of this Alert, drug and device companies and health care providers should consider the risks when assessing whether to offer, pay, solicit, or receive remuneration related to speaker programs.
Should you have any questions regarding the Alert, any member of Fox Rothschild LLP’s Health Law Group would be happy to assist you.