8 Things to Avoid in Life Sciences Speaker Programs

On November 16, 2020, the Office of the Inspector General issued a Special Fraud Alert regarding speaker programs in the health care industry. This was the first Special Fraud Alert in six years, and only the fourth issued in the past two decades. Only 11 have been announced in total since they began in 1994. In other words, listen up, because this is a warning! 

In the past three years, drug and device companies have reported paying nearly $2 billion to health care professionals (HCPs) for speaker-related programs. The OIG has taken note, and has significant concerns about such remunerations and the value of these programs. Specifically, the concern is that these enticements are meant to induce ordering or prescribing items paid for by federal health care programs. In the eyes of the OIG, if that intent is present, both the company and the HCPs may be subject to criminal, civil, and administrative enforcement actions.

It's important to note that this Special Fraud Alert is not intended to discourage meaningful HCP training and education. But it does highlight certain inherent risks of remuneration related to speaker programs. As a result, drug and device companies, as well as HCPs, should carefully consider the risks when assessing whether to offer, pay, solicit, or receive remuneration related to speaker programs. Furthermore, under the Biden-Harris Administration, compliance enforcement is likely to expand. Be prepared! Smart executives would be wise to remember this as we emerge from pandemic shutdowns and resume in-person gatherings. 

Understanding the difference between what's considered ethical and what's suspect is critical to running a successful speaker program. The list below illustrates key examples of what will have the OIG raising an eyebrow, but it's not exhaustive. The presence or absence of any one of these factors is not the only determination of whether a particular program would be suspect under the anti-kickback statute, but they're certainly all worth your attention and thoughtful consideration. 

1. Lack of substance

A company that sponsors speaker programs where little or no substantive information is actually presented is going to raise some flags. Programs should be specifically focused on drugs and devices and news and innovations within the industry.  

2. Fancy food and drink 

If you're serving alcohol, especially if it's free, or a lavish meal, you might catch the attention of the OIG. Keep food and beverage costs modest – it's an industry event, not a party.

3. Location, location, location

If your program is being held at a venue that seems more fun than work-oriented, reconsider the place. The setting should be conducive to the exchange of educational information – think conference rooms, not restaurants or entertainment and sports centers. 

4. No recent updates to product 

Sponsoring multiple programs on the same topic or product, especially if there have been no recent or relevant updates to it, is frowned upon. Likewise, if a significant period of time has passed with no new medical or scientific information and/or it hasn't been recently FDA-approved, holding a speaker program would be risky. To be safe, time programs to coincide with substantial changes and announcements about your products or research.

5. HCPs attending repeat programming

When health care providers attend multiple programs on the same or closely related topics, it raises a red flag. This can include being a repeat attendee and/or speaker at multiple programs.

6. Including non-relevant guests 

Individuals who don’t have a legitimate business reason to attend a program should be left off the guest list. To meet the OIG's guidelines, friends, significant others, and family members of speakers or attendees should stay at home. The same goes for employees, medical professionals, and other staff who would not directly benefit from the program's information.

7. Hiring speakers based on potential (or past) revenue

Your company’s sales and marketing teams should not influence the selection of speakers (or attendees). Hiring talent or identifying participants based on prior or potential revenue is considered bad form by the OIG. 

8. Paying speakers too much 

Paying or otherwise compensating HCP speakers more than the fair market value (FMV) for their services is another warning sign. Avoid this by paying fairly, but within reasonable parameters. There are very reasonable software programs available to assist with FMV determinations.

With the recent Special Fraud Alert, trends toward stricter compliance regulations, and the likely tendency for the Biden-Harris administration to be more skeptical of industry motivations, it's more important than ever to make sure your compliance program is in order. Compliance isn't just nice to have, it's essential for peace of mind that you can compete and win aggressively in the marketplace! That’s what I call winning with compliance!

To ensure your speaker programs are compliant, better understand compliance risks and guidelines, or enhance an existing compliance program, contact me at [email protected] or 617-800-3704. Working with TRESTLE Compliance will help you develop a compliance action plan that will lead your company to commercial success!

Copyright ? Steve Vincze 2021.  All rights reserved.

#compliance #trestlecompliance #lifescience #healthcare #risk #pharmaceuticalsales #pharmaceuticalcompany #pharmaceuticalindustry #ethics #departmentofjustice #fraud #medicalfraud #fraudalert #speakerprograms