The healthcare industry can be full of tempting offers, many perfectly legal, though there are some that are not. To make matters more difficult, illegal ones can appear above-board and acceptable when, in fact, some aspects of them pose a significant legal risk to you and your business.
For example, speaker programs are a popular tool for medical device and pharmaceutical companies to expose their products to a target audience of healthcare professionals. These programs are also popular with industry experts and innovators as a way to network, build their professional or brand value and, in many cases, receive some attractive compensation on the side—often in the form of an honorarium or free food and lodging in a highly desirable location where these types of conferences and presentations are held.
However, it’s important to note that the Department of Health and Human Services Office of the Inspector General and the Department of Justice have investigated and resolved numerous fraud cases involving allegations that remuneration was offered and paid in connection with speaker programs that violated the Federal anti-kickback statute. The Federal government has actively pursued civil and criminal cases against companies and individual healthcare professionals involving speaker programs.
Where the situation can slip from legal to illegal is if remuneration is paid purposefully to induce or reward referrals of items or services payable by a Federal healthcare program. The Federal 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.
As an experienced regulatory consulting firm that provides FDA regulatory compliance as well as other Federal statutory assistance to medical device start-ups, we counsel our clients to be extremely cautious about using speaker programs as a means to promote the visibility and efficacy of their products to a healthcare provider audience.
If you are a medical device manufacturer that sponsors speaker programs as a part of your marketing strategy, your company may be subject to increased scrutiny if you organize or pay remuneration in association with your program. That legal scrutiny can also extend to any healthcare professional paid to speak and any healthcare attendees who receive remuneration, such as free food and drink.
So how do you know if your company’s speaker program is potentially fraudulent, or if your participation as a speaker may be suspect? Here are some program characteristics that may trigger an investigation:
- The program offers little or no substantive information.
- Alcohol is available or a meal exceeding modest value is included.
- The program is held in a non-educational location – for example, at an entertainment or sports venue.
- The sponsor offers a large number of programs that are essentially the same, with no significant difference in the information provided, if any.
- 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.
- Attendees include individuals who don’t have a legitimate business reason to attend the program, like friends, significant others, or family members of the speaker or attendees.
- Speakers are paid more than fair market value or are compensated based on past business conducted between them and the program sponsor.
Companies should assess the need for speaker programs given the risks associated with offering or paying related remuneration and consider less risky alternatives to convey information to a target audience. If you have compliance questions about a specific speaker program arrangement involving remuneration to referral sources, contact us – our team of regulatory experts is ready to assist you.
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MEDIcept is an international consulting firm offering a full portfolio of services to the medical device and IVD industry. For over 25 years, our unique consulting practice and multidisciplinary team of former FDA, Notified Body, and industry experts have assisted hundreds of companies of all sizes with innovative, compliant, trusted, and cost-effective Regulatory, Quality, Clinical, and Engineering solutions.
For additional information, please contact Susan Reilly at SReilly@MEDIcept.com.