Interested in the glamorous world of pharmaceutical events and big drug-company money? Where dashing doctors swill champagne and multimillion-dollar budgets barely raise CFOs' eyebrows? Where the only limits are your own creativity and willingness to lavish care and luxury on attendees? Well, you'd better be prepared to swallow a big bowl of alphabet soup first, because a handful of acronym-laden regulatory organizations with names like OIG and ACCME have just about put an end to the party.
Starting several years ago, government and nonprofit watchdogs began to impose dozens of guidelines and laws on medical meetings, with two basic goals in mind: preventing pharmaceutical manufacturers from using meetings as kickbacks for doctors who distribute their drugs, and preventing the drug companies from running marketing events in the name of education. In this multibillion-dollar industry the stakes are high, and the recent laws have made many medical events logistical nightmares. But meeting planners are a resourceful bunch, and many of those that work in this lucrative market have found creative ways to work within the rules.
The Letter of the Law
If you think staying on top of all the guidelines and regulations surrounding continuing medical education (CME) is more difficult than brain surgery, you might be right. But by keeping abreast of the basics, medical meeting planners can provide better events for their clients—while staying within the directives of the law. "Companies that produce medical meetings need to be informed of industry guidelines," says Jacqueline Parochka, president of Excellence in Continuing Education, a CME consulting service based in Gurnee, IL. This way planners can obey the standards of regulators, while also pleasing physician attendees, who can be notoriously difficult.
The regulatory revolution in medical meetings began in July 2002, says Parochka, when the voluntary Pharma-ceutical Research and Manufacturers of America Code went into effect, prompting drug companies to examine their spending on CME events and the educational value of the gatherings. Since doctors in most states are compelled to complete CME to maintain their licenses, they became captive audiences at the events, which sometimes degenerated into infomercials for the companies that sponsored them.
But the boondoggle couldn't last forever, and by April 2003, the drug companies' wining and dining of doctors had attracted the attention of the federal government, in the form of the Office of the Inspector General (OIG). "The Office of the Inspector General's document really set the tone for the industry," says Parochka, "because it said that if you are giving kickbacks in any shape or form, or trying to disguise the content in any way, you could go to jail because it is a federal offense. So that made everyone stand up and take notice."
"The OIG does a lot of investigations and provides guidance, but we have relatively little prosecutorial authority," explains Donald White, a spokesperson for the OIG. "Most offenders are handled by the Department of Justice. But there are administrative fines we can impose, and we also have the authority to ex-clude people from receiving medical reimbursement."
Mainly, says White, "The rules have to do with how pharmaceutical manufacturers comply with federal laws having to do with Medicare, Medicaid, and other federal health-care programs. And there is a section having to do with marketing by the pharmaceutical companies." But the OIG guidelines were enough to shake up the way the big drug companies were doing business, and the medical meetings industry took notice.
This year, the Accreditation Council for Continuing Medical Education (ACCME), which certifies all CME courses so that they count towards physicians' state licensing requirements, is expected to ratify a new set of guidelines that reinforce the directives of the OIG. "The final draft of the ACCME guidelines was approved and the final action will be taken at the council meeting in September 2003," says Parochka. "These standards for commercial support are putting into place a fortification of the OIG guidelines, so we now have two sets of rules working together."
Getting Creative (Within the Rules)
Even though thousands of words have been written to regulate medical meetings and CME, planners say there's a lot of wiggle room to be found within the codes, as long as event producers and the clients are on the same page. "Basically, the character of the event is determined by the pharmaceutical company that contacted you and asked you to set up the meeting," says Denise Baran, vice president of operations at Sacramento, CA-based Spectrum Events, a longtime producer of events for drug companies. "The guidelines are helpful but each corporation reads them differently. How companies enforce the rules is strictly up to them."
The specifics of the rules, insiders say, are open to interpretation. "Everyone recognizes that the basic premise of the rules is that the companies are not to influence physicians to prescribe the drugs" or provide kickbacks, explains Baran. "But even if you study the guidelines closely, it can be ambiguous as to whom they apply to. Some organizations say the rulings are more for sales and marketing events, and only apply when sales members are present. Others feel that the rules don't apply to clinical meetings at all."
The guidelines have had a particularly noteworthy impact on the areas of site selection, meals, family participation, attendee giveaways, entertainment, and recreation. But even within these categories, savvy planners have found ways to please finicky doctors and drug companies by offering the best options available, while staying within the letter of the law.
When it comes to venues for housing, meals, or meetings, planners say to stay away from four-star hotels or glitzy-sounding establishments that could raise the eyebrows of regulators. "We have a customer that won't go to any place with the word 'resort' in it," says Baran. Another pharmaceutical company wanted to have an off-site meeting, she says, but nixed a local theater as a venue, because it could be viewed as entertainment. But others say that name-brand properties are still fair game, as long as luxury properties are avoided. "I still see the major hotels handling the business," says Parochka. "There are only so many places in the country that can handle these groups."
Likewise, the guidelines have banished flashy meals from CME, but planners can still arrange food and beverage service so that the doctors eat well. "We used to have really cool theme parties, but now we're doing a lot of simple meetings with chicken for dinner," says Baran. In some cases, she says, the changes come down to words. "It's a difference of how you word the invite—you can't say, 'We're having a scrumptious meal.' You have to say, 'We're having a meal.' " In other words, if you're serving lobster and filet mignon at dinner, don't put it in writing.
And planners have found ways to provide entertainment for attendees without breaking the rules. "To get around the regulation of entertainment, rather than have a party in the hotel, a way to get the same results is to go to a themed restaurant," explains Baran. "That way you are not bringing the entertainment to the venue."
Anti-kickback laws have affected pillow gifts and other meeting giveaways, says Baran, but gifts are still given. "The gifts are a big thing. They have to be functional for the physicians," she explains. "Before, if a meeting was held in Orlando, you'd give attendees beach towels, beach bags, and tickets to Disneyland. Now, at the same meeting, you'd give them laser pointers and pens, so the gifts are more practical and functional."
The guidelines also mean that family attendance at CME events, once a fixture of medical meetings, has dropped significantly. "Before the family would come to everything and it would be paid for," says Baran. "Now they have to pay their own way. If you bring a guest to dinner they have to pay for it. It's kind of embarrassing."
One thing planners haven't found a way around are the rules that forbid recreational activities as part of CME. "The recreational options are totally out. Even in sales and marketing you can't take your doctors golfing anymore," says Baran. "And there's no way around that, really. At least I haven't figured out a way, yet. And I try to be creative."
Cause for Applause
If it sounds as if these regulations have made medical meetings and CME a lot less fun and a whole lot more time-consuming, they have. But the good news is, medical meetings remain one of the strongest sectors of the meetings industry, even if these events aren't as glitzy or growth oriented as they used to be. In fact, there were 1,240 medical meetings in the first half of this year, according to the 2004 Medical Industry Conference Calendar. That's about seven medical meetings each day.
Experts say that both event providers and attendees foster the steady demand for medical meetings. And it's not just a matter of earning those CME credits. "While self-directed learning is very important, physicians like to associate with colleagues, and that needs to take place in a meeting environment," explains Parochka. "That goes for the whole industry. They like to see their cohorts."
Likewise, planners who work with the drug companies don't see any slackening in the supply of medical meetings soon. Although some meetings have disappeared, others are growing in number. "The drug dinner meetings are gone," says Baran. "And we used to do roundtable meetings focused on particular drugs, and that has stopped." But regional, issue-oriented meetings have become more popular, and drug manufacturers will continue to use these events as a point of contact with physicians. "Pharmaceutical companies will always have to come out with new drugs" to stay competitive, says Baran. "The market's not as hot as it was, but the meetings will continue."