FOR THOSE OF YOU waiting for a list of do's and don'ts from the Office of Inspector General in order to help you comply with the OIG's new pharmaceutical marketing guidance and avoid violating federal anti-kickback laws, don't hold your breath.
“We probably never will provide such a list,” said Mary E. Riordan, senior counsel, OIG, speaking at the American Medical Association's 14th Annual Conference of the National Task Force on CME Provider/Industry Collaboration. Held September 8 to 11 in Chicago, the meeting attracted 437 participants. “We can never write a list that captures all the problematic arrangements; if we did, just as soon as we wrote it, a creative person would come up with a way to skirt items that were on the do-not-do list. But probably more important, we can't write a list of do's and don'ts for an intent-based criminal statute. We have to make an analysis of all the facts and circumstances of each particular arrangement before it can be prosecuted. There are not a lot of easy answers.”
So what can CME providers and commercial supporters do to protect themselves against government prosecution? You need to ask the following questions, said Riordan:
Is the funding based on referrals [the volume of prescriptions speakers or attendees will be able to generate for the company providing the funds]?
Is the funding for bona fide educational purposes?
Does the manufacturer influence or control the substance or context of the program?
Is the speaker/presenter paid by the manufacturer, and does he or she have other relationships with the manufacturer?
The OIG guidance recognizes the benefit and legitimacy of industry-funded CME, “but — and there is always a but — you have to ask these questions to get at the true nature of the relationship,” she said.
Attendees wanted more specifics. “Suppose that a pharma company gives an unrestricted educational grant of $500,000 to an accredited provider and recommends the lead speaker of the program, who then is paid $10,000 out of that $500,000 by the provider. Is that a violation?” asked Lewis A. Miller, chairman, Intermedica Inc., based in Darien, Conn.
“We can never answer questions like that,” Riordan responded. “It's going to depend on the facts and circumstances. We would look at the amount given to the physician and ask about how the $10,000 [fee] was determined, and whether or not that is an appropriate amount of money. To me, as a government lawyer, it sounds like a lot of money. If the accredited provider followed all the industry guidelines, the risk would be less.”
Following up on Miller's question, Marc Wilenzick, senior corporate counsel, Pfizer Inc., New York, said, “Having reviewed hundreds of grant requests and rejected a reasonable proportion of those because of what the provider was suggesting that we fund, I think there's a dilemma that we have to face. People have different views about whether we should tell the provider how to run the program. We could say, for example, that $7,200 is the proper fee or $14,000 is the fair market value. We can look at the program and say we think there's not enough discussion of this therapy or that therapeutic alternative, and propose changes in the interests of balance as we see it. It is not clear to me whether the OIG is advocating manufacturers take a more aggressive approach or whether we should distance ourselves and say [to the accredited provider], ‘If you are going to do the program, you're responsible; you have obligations to the profession, to the public.’ That message is not clear and it creates an ‘It's your problem if you do, your problem if you don't’ dilemma that is not in the interests of the public or profession.”
Riordan answered: “In an ideal world, if CME could be put on without funding from pharmaceutical manufacturers, my office would be a lot more comfortable and the Department of Justice would be a lot more comfortable. That's probably not a realistic option. It is not within the OIG's bailiwick to regulate the content of CME or to regulate the content of anything the manufacturer puts out. That's the bailiwick of the FDA.” But if the OIG did investigate the funding of a particular CME program, it would look at theand the content to ascertain whether the program “was a bona fide educational activity or whether it was something that was closer to marketing,” she said. “The preference would be for manufacturers to have less influence over the content than more. That is the bottom line.”
Riordan suggested that accredited providers and commercial supporters who have questions about specific arrangements — but not hypothetical situations — take advantage of the OIG's advisory opinion process. A favorable response is a binding, written opinion, she stressed. Another, faster option is to call staffers in the industry guidance branch for their advice. She also said that the OIG has posted descriptions about recent investigations and settlements on its Web site, http://oig.hhs.gov.