Legal Matters

Legal Matters No Steak, No Wine? OIG Cautions Against Physician Speaker Programs

By Asher D. Funk, J.D. Dayna C. Laplante, J.D. Polsinelli, PC

In a recent Special Fraud, the Department of Health and Human Services Office of Inspector General (HHS-OIG) raised significant fraud and abuse concerns with companies offering or providing remuneration in connection with physician speaker programs. Speaker programs typically involve one health care professional presenting to others on a company’s drug or device, or a disease state relevant to the company’s products, in exchange for a speaker honorarium. While speaker programs may have some legitimate purposes, HHS-OIG warned of risk the programs create, if one purpose is to induce or reward federal health care program referrals.

Because the HHS-OIG rarely issues Special Fraud Alerts and has not done so in over six years, this guidance warrants the attention of health care providers along with a review of health care entities’ current practices.

In the Fraud Alert, HHS-OIG identified the following non-exhaustive list of “suspect characteristics,” which may be present in speaker programs and increase the risk of liability under the Anti-Kickback Statute: • Little or no substantive information is presented at a company-sponsored speaker program; • Alcohol is available or free, or a meal greater than modest value is provided to attendees; • The program’s setting is not conducive to the exchange of educational information (e.g. restaurants, sports or entertainment venues); A company sponsors a large number of programs on the same or similar topic, particularly where there is no recent substantive change in relevant information; No new medical or scientific information, or a new FDA-approved or clear indication for the product, has occurred in a significant period of time; Health care professionals attend the same or substantially similar programs more than once; Program attendees do not have a legitimate business reason to attend (e.g. significant others of the health care professional attendee, employees of the speaker’s medical practice, others with no use for the information, etc.); Sales or marketing personnel influence the selection of speakers or the company selects speakers or attendees based on past or expected revenue they will generate by ordering company products; and, Compensation the company pays health care professionals for speaking is more than fair market value or takes into account the volume or value of past or potential business generated.

HHS-OIG emphasized in the Fraud Alert that many investigations and enforcement actions under the federal False Claims Act and Anti-Kickback Statute included one or more of the characteristics listed above. HHS-OIG also acknowledged the nearly $2 billion that drug and device companies reported as being paid to physicians for speaker-related services in the last three years. A recent settlement between Medtronic USA Inc. and the Department of Justice highlights these enforcement efforts and the importance of properly

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