With heightened government scrutiny on educational forums, biopharma manufacturers need a sound framework that demonstrates they are following best practices.
Travel is ramping back up, and live events are possible again. Many life sciences companies are restarting speaker programs, which were put on hold at the start of the pandemic more than two years ago. But companies can’t simply go back to the policies and practices that used to determine their involvement and investment.
In the past two years, the regulatory and compliance environment has become stricter. In 2020, the Office of Inspector General (OIG) of the US Department of Health and Human Services put the industry on notice that paying healthcare providers (HCPs) to speak at company-sponsored events risks violating the federal anti-kickback statute—if proper rules aren’t followed. The OIG’s so-called Special Fraud Alert led, in turn, to a revision of the code of conduct published by the Pharmaceutical Research and Manufacturers of America (PhRMA), which went into effect at the beginning of this year. In other words, there are now stricter limits on the involvement of speakers who present information about a company’s drugs or devices—and clear risks if the guidelines aren’t followed.
The overall intent of the OIG’s work in this area is to ensure that there’s a real educational purpose for every program, and that there’s nothing which can be construed as an attempt to encourage or reward practitioners to use or prescribe a company’s products. In practice, this affects where speaker events can be held, what can be provided to speakers and participants, and who can be selected to participate. What’s more, there’s an obligation on every organization to maintain sufficient documentation to show that its speaker program complies.
In our work at Grant Thornton, we have developed a framework that can help clients organize their compliance initiatives. This framework, informed by the OIG’s conclusions and PhRMA’s guidelines, can help companies be confident they are meeting their obligations. The key principles in our framework include:
Speaker programs need to be held at an appropriate venue. It is no longer acceptable for these events to be scheduled at golf courses or fancy resorts, and they can’t be timed to bring attendees to town for a desirable sporting event or concert. They also can’t simply be part of an expensive meal. Rather, the company sponsoring the program needs to be able to show that the venue was selected to help foster an educational purpose.
The OIG has cited as inappropriate speaker programs that were held as part of fishing trips or took place at a winery—or an adult entertainment venue. The new standard also requires that any meals provided must be modest, and the company sponsoring the event can’t pay for alcohol. Organizations should retain receipts to demonstrate they met these standards.
It has become vital for companies to document the educational purpose of every speaker program. Presentations should be recorded and archived. Materials provided to participants such as slide decks or handouts should also be preserved.The goal is to demonstrate the value of the event and, ideally, the ways in which an in-person presentation was better than other methods of imparting such information to providers. The OIG has specifically highlighted as problematic speaker programs where little substantive information was presented, and has noted that there are many other ways, besides an in-person event, to educate HCPs about a medical product.
Even for virtual speaker events, which became so much more common during the pandemic, companies should be sure to archive the presentation and accompanying materials to help establish that the speaker’s remuneration was appropriate.
Organizations also need to keep track of speakers and attendees. In addition to being able to establish the relevance of what was presented during a speaker program, it’s important to document who gave the presentation and who attended.
The OIG has specifically noted that cases under the anti-kickback law have in the past alleged that lucrative payments went to speakers as a reward for prescribing a drug or device at a high level or that remuneration was conditioned on sales targets. The point of tracking who speaks and who attends is to show that this has not occurred. Companies need to be able to demonstrate that they are not favoring high-prescribers.
Tracking attendance, along with the effort to archive what was presented at an event, can also help a company to show that attendees are not being brought to multiple events which are covering substantially the same topics—another practice that could be a red flag.
Perhaps most important of all: Life sciences companies with speaker programs should have an appropriate policy in place. Formal policies describing a company’s standards—in line with the principles outlined earlier—need to exist and be enforced.
An explicit policy can establish the behaviors and practices that the sales team and others must uphold. It also can establish internal procedures that create important checks and controls. For example, the policy might demand that an authority from the company’s compliance team or legal office approve speaker events.
Establishing a clear policy for the scheduling and conduct of speaker programs will go a long way toward protecting a company against the risk that it will run afoul of the OIG’s guidance or violate the anti-kickback statute.
Speaker programs can be a useful and appropriate tool for life sciences companies to better convey accurate information about their medicines, treatments, and devices to HCPs. Approached with that purpose in mind—and with past episodes of abuse in mind, too—an organization can easily establish the procedures and parameters that will make such events successful.
Marisol Cooke, Senior manager, advisory life sciences operation transformation practice, Grant Thornton