HHS-OIG Focuses on Speaker Programs with Special Fraud Alert

HHS-OIG Focuses on Speaker Programs with Special Fraud Alert

The United States Department of Health and Human Services Office of Inspector General (HHS-OIG) has issued a "Special Fraud Alert: Speaker Programs". The Fraud Alert points out potential risks associated with company sponsored events by pharmaceutical and medical device companies that hire physicians to educate healthcare professionals about the benefits and risks associated with company drugs. According to OIG, pharmaceutical and device companies have paid nearly $2 billion to healthcare professionals for speaker-related services, based on Open Payments data available through the Centers for Medicare & Medicaid Services.

In recent years, there have been numerous fraud cases and settlements with OIG and the Department of Justice (DOJ) involving allegations that pharmaceutical and device companies have violated the anti-kickback statute by paying remuneration to physicians in connection with speaker programs with the intent of inducing HCPs to prescribe company products. Such cases have demonstrated that not only companies, but HCPs may face liability under the anti-kickback statute. The Fraud Alert includes some of the allegations found within these cases. For example, such cases have involved generous compensation to speakers "under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend". OIG cites studies that point out that HCPs are more likely to prescribe a company's products when receiving remuneration from the company which may induce the prescribing of products paid for by Federal health care programs.

The Fraud Alert also states that "OIG recognizes that the lawfulness of any remunerative arrangement, including speaker program arrangements, under the anti-kickback statute depends on the facts and circumstances and intent of the parties. Such intent may be evidenced by the speaker program’s characteristics and the actual conduct of the parties involved."

OIG provides in the Fraud Alert a list of characteristics, meant to be illustrative and not exhaustive, that could potentially be suspect under the anti-kickback statute. Below are some of the factors provided by OIG:

• 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;
• 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;
• 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; and
• The company pays HCP speakers more than fair market value for the speaking service.
• It is notable that OIG is issuing this alert during the pandemic emergency, while many companies are curtailing many in-person activities. OIG points out that whenever payments are offered or paid to HCPs, the risks remain and also offers this Fraud Alert if companies resume in-person speaker programs.

A copy of the Fraud Alert is available here.

For more information regarding OIG enforcement, please see the Government Prosecutions section of the Enforcement Actions Database.