By Divya Srivastav-Seth, Esq.

The Office of Inspector General at the United States Department of Health and Human Services (“OIG”) issued a rare Special Fraud Alert (“Alert”) earlier this week aimed at speaker programs sponsored by pharmaceutical and medical device companies. The Alert is the first issued by the OIG since 2014 and signals its increasing concern about speaker programs where a heath care professional (“HCP”), usually a physician, receives remuneration for a speech or presentation to other HCPs about a drug, device or a disease state on behalf of the company. 

The Alert warns that company sponsored speaker programs involve certain inherent risks that could potentially implicate the Federal Antikickback Statute (42 U.S.C. § 1320a-7b(b)(1)(2))(“AKS”). The AKS makes it a criminal offense to knowingly, willfully solicit, receive, offer, or pay any remuneration to induce or reward among other things, referrals for or orders of items or services reimbursable by a Federal health care program.

The OIG notes that it has increasingly been investigating allegations and pursuing enforcement actions regarding such speaker programs which have an inherent risk of providing a potentially prohibited mechanism for the inducement of prescriptions or ordering of products reimbursable under Federal health care programs in violation of the AKS. 

The Alert states that its intent is not to discourage meaningful HCP training and education, but rather to highlight certain inherent risks of remuneration related to speaker programs. The OIG identifies the following characteristics as indicative of suspect speaker programs: 

•  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.
• 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).
• 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 HCP 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 HCP 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 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.

The Alert states that these characteristics are illustrative and not exhaustive and that programs will be evaluated on individual facts and circumstances.

The OIG also notes that companies who are planning on resuming speaker programs that were necessarily paused during the COVID-19 pandemic, should carefully weigh the risks involved in resuming such activities in light of the Alert and consider alternative less-risky means for conveying information to HCPs.

For more information, contact Divya Srivastav-Seth at dss@spsk.com or 973-540-7855.

DISCLAIMER:  This Alert is designed to keep you aware of recent developments in the law.  It is not intended to be legal advice, which can only be given after the attorney understands the facts of a particular matter and the goals of the client.