Federal authorities recently issued a (ahem) *strongly worded* warning to pharmaceutical and medical device companies about speaker programs and kickbacks. In an especially ominously named Special Fraud Alert, the very, very official-sounding Department of Health and Human Services Office of Inspector General (HHS-OIG) stated it was “skeptical about the educational value of such programs” and that companies should “consider alternative less-risky means for conveying information.” On a scale of zero to a Tom Cruise sock-slide, speaker programs rank at about the “eating a six-day-old hot dog” level.
Speaker programs are one of the most popular marketing tools used by the life sciences industry to promote and educate healthcare professionals (HCPs) about the benefits, risks, and best practices of prescribing their drugs or devices. However, over the past few years, these company-sponsored events have been rife with allegations of inappropriate conduct or off-label promotion.
The improper use of a speaker program can expose a company to large penalties, large fines, and/or XL Jumbo Mega-Size penalties and fines. One pharma company recently agreed to pay $678 million to settle claims that it systematically violated the federal False Claims Act and the Anti-Kickback Statute with its physician-led speaker programs. The settlement was the largest ever for speaker programs, and we should know. Once we commissioned Beyoncé to speak about programming speakers. (It turns out her knowledge of next-gen AV equipment is more remedial than you’d expect.)
With the help of Real Biz Shorts by Second City Works, here are three industry best practices to follow that will help alleviate the risks associated with speaker programs:
“Holding a speaker program at a location that serves alcohol or is not conducive to learning” was high on HHS-OIG’s list of suspect characteristics. In one cited example, the average food and alcohol cost per attendee was over $500. If you have to host a speaker event at a restaurant, make sure it has a private room, and stay within your company’s cost-per-person limit. Bread baskets are nice, too.
Speaker programs at luxurious locations may be seen as intent to influence and can open a company up to liability--even without evidence that a speaker event actually resulted in an increase in prescriptions or medical device sales. Employees can refuse to engage in conduct that violates the Anti-Kickback Statute and are protected from retaliatory action by their employer. Save your razzle-dazzle for your factual information, not your infinity pool.
Unlawful prescription kickbacks are intended to influence doctors' behavior. Some pharma companies reward physicians who write a minimum number of prescriptions by compensating them as “speakers” or “consultants” in connection with bogus speaker programs or advisory boards. Make sure HCPs have a legitimate business reason to attend your speaker program. That legitimate reason might be a UV sanitized, all-you-can-eat-with-freshly-bleached-hands nacho bar. In that case, it’s not only legitimate...it’s legit.
Want more? Contact us to learn how Real Biz Shorts can help your organization minimize the risks associated with speaker programs and kickback violations.