The Department of Health and Human Services Office of the Inspector General (OIG) published a Special Fraud Alert on November 16, 2020 (the Alert) regarding a common practice within the pharmaceutical and medical device industry known as "speaker programs."
The Alert suggests that the fraud and abuse risks associated with hosting or even attending such programs outweighs any potential educational benefit, unless very strict protocols are followed.
Generally speaking, a speaker program is an in-person event sponsored by a pharmaceutical or device manufacturer where a non-employee of the company – another physician or scientist – will speak to the science, uses, and benefits of a particular drug or device product to an audience of fellow physicians, who are, importantly, in a position to recommend or prescribe that particular product. These events can occur over dinners, educational conferences, or other professional gatherings. The inherent risk in such programs is that the manufacturer could provide improper remuneration to the speaker and even to the attendees, which could affect clinical judgment when it comes time to prescribe a particular therapy for a patient, in violation of the Federal Anti-Kickback Statute (AKS). The government's concern is always that any remuneration – anything of value – can result in the clouding of clinical judgment and disregard for the best clinical and financial (cost) decision for patients of federal health care programs, such as Medicare, Medicaid, or TRICARE.
Recent settlements have shown that the government is still very active in its enforcement of AKS matters, particularly with respect to speaker programs. The Alert emphasizes recent enforcement actions and provides a non-exhaustive list of risk factors that the OIG says should be considered when determining "whether a particular arrangement would be suspect" under the AKS. Such factors include whether:
- 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; or
- 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.
The OIG specifically addressed the fact that since industry is operating under the unique confines of a global pandemic, pharmaceutical companies should carefully evaluate "the need for in-person programs given the risks associated with offering or paying related remuneration and consider alternative less-risky means for conveying information to" health care providers. As the OIG only rarely issues Special Fraud Alerts, pharma and device manufacturers would do well to carefully evaluate how speaker events have been conducted in the past, and the extent to which further measures going forward can minimize AKS risk.
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