CME Events Face Renewed Scrutiny

Physician-attended meetings have been a headache for pharmaceutical companies for years, especially in 2002 with the release of The Pharmaceutical Research and Manufacturers of America Code, and in 2003, when the U.S. Office of the Inspector General issued guidelines curtailing the value of gifts pharma companies could give to physicians, lavish dinners and incentive trips.

Pharmaceutical companies often sponsor continuing medical education events, but the practice has been increasingly scrutinized by the government, wary of corporate influence on the U.S. healthcare industry. Regulators fear that physicians could receive kickbacks from pharma companies that attempt to persuade doctors to using their products.

This year, with new Medicare rules in place, federal regulatory scrutiny has been renewed. The government will become the single largest purchaser of pharmaceuticals, and regulators are expected to crack down even further on continuing medical education events, associate U.S. attorney at the Department of Justice in Philadelphia James Sheehan told attendees at the second annual Pharmaceutical Meeting Planners Forum earlier this year.

The continuing medical education industry has formed several advocacy groups and a professional certification program to improve the segment's reputation and counter excessive event regulations. Currently, CME providers can be accredited through the Chicago-based Accreditation Council of Continuing Medical Education.

However, the larger Alliance of Continuing Medical Education said it will not offer a formal certification program for CME at this time. Instead, said Bruce Bellande, executive director of the Birmingham, Ala.-based group, the alliance will focus on educational programming.

"I think the operative words there are 'at this time.' We're looking at more of a professional model of maintenance of competence. It really begins with what we established of eight competency areas for CME professionals," Bellande said, adding that the alliance is building performance indicators, self-assessment tools and an educational curriculum for each of those areas.

Many of the issues that the advocacy group addresses extend beyond dealing with regulators, to public interest on how tax dollars are spent.

"For example, the commercial support of continuing medical education permeates and transcends across a lot of different interests," Bellande said.

The group also plans to advocate the value of CME programs. "If you're not in continuing medical education—and this is not a criticism, just a reality—you really don't understand what it is and the nuances that surround it," Bellande said.

Concerns over lavish gifts and parties for doctors, sponsored by pharmaceutical companies, have become confused with true CME events. In addition to CME scrutiny, pharma companies operate under a multitude of government-contract regulations. Bellande said he was surprised to learn 25 percent of government expenditures are on healthcare.

"The government is spending more and more of our money, taxpayers' money, on healthcare—particularly drugs and devices. It's intuitive and relatively likely that regulations will continue to be released because of the nature of wanting to protect the public's interest," Bellande said.

The meetings industry, corporate providers of CME events and the hospitality industry all have approached the alliance for help in navigating regulations.

Resort destinations have been hit especially hard, as many pharma companies try to avoid any perception of excessive spending, he said.

Frank McVeigh, president and CEO of McVeigh Associates, a meetings and incentive management company that represents such major pharmaceutical companies as AstraZeneca Pharmaceuticals and Merck & Co., said his company and clients have recognized the need for more education on government regulations. Pharmaceutical companies are holding more internal meetings to learn about regulations for external and CME events, and require vendors to be experts as well.

"We sort of separate the forces on regulatory issues. Most of our pharmaceutical clients are having meetings in relationship to the regulations," McVeigh said. "It's mutual. We look to their legal and compliance areas and also what we see in upcoming legislation."

Every pharmaceutical client has its own internal regulatory division that reviews every proposed meeting to ensure compliance with legal requirements.

"Companies are becoming very cautious in terms of money spent on programs and in terms of what the value of the meeting is. Most pharmaceuticals, before they can have a meeting, have to go through regulatory. There's a gatekeeper now, and the gatekeeper says: 'What is this meeting for? Do you really need this meeting? What's the value?' It's very different than a couple years ago."

Increased scrutiny has added another time-consuming step to a lengthy process of planning pharmaceutical events.

"Sometimes they have a new drug coming out and they can't get it out as quickly as the product people," McVeigh said.