Be careful accepting that speaking fee.

I left academia in 2009 after 20 years of research as a student, grad student, postdoc, faculty member, and core director. That was also about the time that the ACA changed some aspects of the Anti-Kickback Statute [42 U.S.C. § 1320a-7b(b)]. This seems like a good place to note that I am not a lawyer or compliance expert. Just an average person offering some advice. For as long as I have been in sales I have been dealing with the Anti-Kickback Statute. When it first came out, it froze companies, since in its broadest interpretation it limited not only buying meals and handing out pens at shows, but doing demonstrations. I have been taking the mandatory HR training on Anti-Kickback and other statutes every year since then. So, imagine my surprise when I heard a physician having this conversation today:

MD: Hi, I wanted to talk about the trip you were offered to send me on, and unfortunately, it appears that it breaks the rules for our university and our state. Were you aware of these rules?

Unheard company response, I assume it went something like this: scramble, scramble, everyone does it, something something

MD: Well, I was told pretty clearly that this was a violation and that the only way I can attend this meeting is to pay myself. That would be an expensive trip….

At this point the MD walked away from my table where he had been standing having this conversation.

There are two reasons I bring this up. First, you might be tied to this rule closer than you think. The law states that anyone associated with a healthcare organization is covered by these rules. That means you basic researcher in a medical school/hospital environment. Or, maybe not. It seems that everyone interprets the law differently. That is why some states, like Virginia, seem to outlaw taking anything from anyone at anytime. No lunch & learns, no coffee meetings, no lunches.

Second, in the past when a company was found guilty of some criminal business activity they were held accountable, but the MD/scientist was not. That is no longer the case. The poor MD above, if he had gone through with the trip, could have been found guilty under the Anti-Kickback Statute. Doubtful, but possible. If so:

Criminal penalties and administrative sanctions for violating the AKS include fines, jail terms, and exclusion from participation in the Federal health care programs. Under the CMPL, physicians who pay or accept kickbacks also face penalties of up to $50,000 per kickback plus three times the amount of the remuneration.

Two points.

  1. Be aware that the laws are complex and innocent mistakes are going to be made. However, there are also reps out there that have been doing it differently for a long time and might think these rules don’t apply to them. You have to look out for yourself.
  2. There are lots of legitimate exceptions to the law, including those covered under the “safe harbor” regulations.

In the end, you should probably pay attention to the compliance training you receive every year. Figure out who your compliance officer is and reach out to them when you have any questions. I do.


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