A special fraud alert was issued by the Office of the Inspector General (OIG) on November 16, 2020 highlighting the potential fraud and abuse related to the offer or payment of remuneration for speaker programs by pharmaceutical and medical device companies. Speaker programs were defined by the OIG for purposes of the special fraud alert as “company-sponsored events at which a physician or other health care professional (collectively, HCP) makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of the company.”
The OIG referenced CMS’ Open Payments database in its alert to highlight the fact that over the past three years, $2 billion had been paid to HCPs for speaker-related payments. Specifically, according to Open Payments, companies paid nearly $2 billion for “compensation for services other than consulting, including serving as faculty or as a speaker at a venue other than a continuing education program” for years 2017, 2018 and 2019.
This Special Fraud Alert highlights some of the fraud and abuse risks associated with speaker programs, particularly pertaining to the Anti-Kickback Statute. The Anti-Kickback Statute makes it a criminal offense to “knowingly and 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.” Speaker programs often include an HCP who is not an employee of the company speaking, on behalf of the company, about their products or disease state which naturally leads to the risk of improper encouragement of inducing referrals or rewards. The OIG references studies that have shown that HCPs who receive remuneration from a company are more likely to prescribe or order that company’s products. The OIG states their skepticism about the educational value of these programs by pointing to the fact that there are many other ways for HCPs to gather the same educational information, such as using online resources, medical journals and other third-party conferences.
The special fraud alert then goes into the details and characteristics around speaker programs which may be evidence of whether the program has the correct intent to be lawful under the Anti-Kickback Statute. Several characteristics were listed that can indicate a speaker program arrangement that may be in violation. A few of these characteristics include:
- 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
- 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)
The full list can be found here.
Although the OIG stated that the Special Fraud Alert is not intended to dissuade significant HCP training and education, it is important that companies are aware of the OIG’s skepticism of these events and should take into account the characteristics and guidance provided by the OIG when assessing the need and weighing the risks for these in-person programs. HCPs should also consider gathering relevant information related to patient treatment using other available means and assessing the risks of receiving such remuneration in response for speaking or attending a speaker program.
To stay up-to-date on industry knowledge, subscribe to MediSpend Perspectives to receive monthly updates from our MediSpend Compliance Solutions team. MediSpend Compliance Solutions is led by a team of experienced attorneys and compliance professionals to assist life sciences companies with the development and implementation of policies and procedures that facilitate compliance with global healthcare laws, regulations and codes of conduct. Areas of expertise include global transparency, HCP engagement and data privacy.