Paid physician speaker programs for drugs and devices under scrutiny by OIG

Many physicians are paid to serve as speakers on behalf of drug or device companies. The type of compensation paid to physicians for such activities can vary, but according to the Office of Inspector General of the Department of Health and Human Services (“OIG”), over the past three years drug and device companies have reported paying nearly $2 billion dollars to healthcare professionals for speaker-related services.

The OIG has investigated and resolved numerous fraud cases that involve allegations of remuneration being paid pursuant to speaker programs in violation of the Antikickback Statute (“AKS”). The AKS generally prohibits the payment of remuneration in exchange for referrals. Remuneration can be anything of value, directly or indirectly, overtly or covertly, in cash or in kind. The OIG is very suspicious of drug and device company organizing and paying for speaker programs and believes that the intent behind such activity is to induce health care providers to prescribe or order the company’s products, which would violate the AKS.

Some of the cases the OIG gives as examples of suspicious activities include the following:

• Selecting high prescribing healthcare professionals to be speakers and rewarding them with lucrative speaker deals.
• Conditioning speaker remuneration on sales targets (i.e. requiring speakers to write a minimum number of prescriptions to receive the speaker honoraria).
• Holding speaker programs at entertainment venues or during recreational events or otherwise in a manner not conducive to a true educational presentation (i.e. wineries, golf clubs, adult entertainment facilities).
• Holding programs at high end restaurants where expensive meals and alcohol are served.
• Inviting an audience of healthcare professional attendees who already attended the same program or the healthcare provider’s friends, significant others or family members who do not really have a legitimate purpose to attend the program.

Because the OIG is sufficiently concerned about these type of activities, they recently put out a special fraud alert on this topic, of which all physicians should be aware. As part of their fraud alert, the OIG warned that parties involved in speaker programs may be subject to increased scrutiny and has recommended that physicians consider the propriety of any proposed relationship with a drug/device company. To help physicians and other healthcare providers understand activities that could potentially indicate a speaker program arrangement that violates the AKS, the OIG has provided a list of some characteristics that they consider to be suspect, including:

• The drug/device company sponsors speaker programs where little or no substantive information is actually presented.
• Alcohol is available or a meal exceeding modest value is provided.
• The program is held at a location that is not conducive to the exchange of educational information.
• The company sponsors a large number of programs on the same or substantially the same topic or product when there has been no recent substantive change in relevant information.
• Healthcare providers attend programs on the same or substantially the same topics more than once.
• Attendees include individuals who don’t have a legitimate business reason to attend the program.
• The company sales or marketing business units influence the selection of speakers or the company selects healthcare provider speakers or attendees based on past or expected revenue that will be generated.
• The company pays more than fair market value for the speaking services or compensation that takes into account volume or value of past business generated or potential future business generated by that healthcare provider.

For physicians who engage in speaking activities on behalf of pharmaceutical or device companies, it is important to closely review your relationships with such companies, as well as the types of events at which you have been speaking in order to assure that there are no red flags. For physicians that are approached by a device or pharmaceutical company, be mindful of these guidelines when considering the opportunity. 

I advise my practices clients to have written policies in place that require review and approval of all outside activities, including paid speaking opportunities. This assures that such opportunities are vetted for compliance as well as other legal concerns. Non-compliant arrangements can put both the physician and the practice at risk.

_{About the Author}

_{Ericka L. Adler, JD, LLM has practiced in the area of regulatory and transactional healthcare law for more than 20 years. She represents physicians and other healthcare providers across the country in their day-to-day legal needs, including contract negotiations, sale transactions, and complex joint ventures. She also works with providers on a wide variety of compliance issues such as Stark Law, Anti-Kickback Statute, and HIPAA. Ericka has been writing for Physicians Practice since 2011.}