It's Been a Frightening Year for CME professionals, with increasing government scrutiny, including the Senate Finance Committee's report on CME. The good news is that the feds are unlikely to pass legislation involving CME in the near future, said John Kamp, PhD (at right), executive director, Coalition for Healthcare Communication, New York; and attorney with Wiley Rein LLP.
Kamp moderated a panel about the regulatory environment on the opening day of the 18th Annual Conference of the National Task Force on CME Provider/Industry Collaboration, held October 17 to 19 in Arlington, Va. The conference attracted a record 704 registrants, many of whom packed the ballroom to hear speakers discuss how to contend with the growing government, public, and media criticism of CME/pharmaceutical industry relationships.
“The staff of the Senate Finance Committee have made it very clear to us that they think that self-regulation is better than government regulation — something that we all agree on,” said Kamp. “How can we proactively demonstrate to ourselves and the world that we are and should continue to be self-regulated?”
Kamp said that it's critical to step up enforcement. “We all support the Accreditation Council for CME as it focuses on the real, right things in [the SFC] report and focuses on serious, immediate enforcement; finding the bad guys and then doing something about them quickly and publicly. We all have to supportin that or we won't have a clear enforcement record that [will be credible to] enforcers and inspector generals.”
He then asked the panelists for their recommendations. (Presenters said they were giving their own opinions, and not speaking on behalf of their organizations.)
Steele: We don't need to sit back and wait to see what the ACCME does. Regardless of what flavor provider you are, whether you're an academic medical center or medical education/communication company, you need to take a proactive role in your organizations, be the voice to the ACCME and provide recommendations. Be a part of the solution instead of part of the problem.
If we're ever going to be a respected profession, we've got to be competent professionals. The National Commission for Certification of CME Professionals is going to oversee a process for ensuring that we can certify competent professionals. [See story, page 17.] All organizations need to be a part of establishing a curriculum. We all need to contribute the expertise for educating competent professionals. Then, we need to step up to the plate within our own organizations to insist that we have the funding to create competent offices.
Overstreet: There's a feeling in this room and throughout the CME community that the Senate Finance Committee, media, and public don't understand CME. What is certified education? What is promotional education? Where is the line between different types of education? All of us need to advocate for the good that CME does. We spend a lot of time talking about violations and noncompliance and the negative stuff, but let's celebrate the good that we're doing. It is going to take all of us individually as well as the work of our professional associations to get that message out there.
Second, I'd like to focus on transparency. I'd like to applaud Lilly for making its grant funding process transparent. Several [other] commercial supporter organizations are evaluating that model. Perhaps providers should consider making their commercial support public, letting everybody know who they get grants from and in what amount. Accredited providers need to be more transparent about the organizations they work with. Certainly, joint sponsorship relationships are supposed to be disclosed. There's a lot that's happening behind the scenes, and educational partners as well as accredited providers need to demand transparency in sponsorship relationships.
And finally, I'd like to encourage all of us to demand that the ACCME be transparent with its data and its rationale for making these new policy changes and recommendations.
Horn: It strikes me the first thing you do is not be guilty of the allegation. [At Pfizer] we have endeavored, as have our sister companies, to take marketing and sales out of the [CME] equation. I think we've been successful in doing that. We need to talk about what we're doing and give examples. Ultimately, that changes the rhetoric. I don't think there's a lot of people really interested in the arcana of regulations. They're interested in more dramatic stories.
Kahn: I'm going to use satellite symposia as an example. In my case, we instituted on-site monitoring by trained staff and physician reviewers, with providers penalized for non-compliance. In 2000, reviewers found bias in 4 out of 15 symposia, or 27 percent. Six years later, they found no bias. Now, how did that happen?
Well, in one case, it was the [supporting] company that put pressure on the communications company to develop a program that would send a promotional message. If you are in a [pharmaceutical] company, don't do that.
In one case, it was a medical education/communication company that said to the [supporting] company: “I can deliver quality CME and the best speakers, and I'll make sure your message gets in there and the provider will never know about it.” Don't do that.
In one case, it was the provider who said: “I've got to make some money on this program. I'm going to hire a medical education and communication company that can give me a big grant from a [pharmaceutical] company, and I'm going to produce CME and all I really care about is how much money I make.” Don't have that attitude. That's not going to help self-regulation.
In one case, it was the speaker who said: “I make a lot of money from my speaker's bureau and I have to protect my relationship with industry; I'm going to insert these promotional slides whether anybody cares about it or not.” If you're a speaker, you're just bringing down the system on us; and if you're a provider, you need to do something about that speaker.
The last player is the audience. In our experience, the audience doesn't care. [Participants] don't recognize bias when they see it, and they don't complain about it because they are there to get some CME hours. So I hereby anoint all of you providers as the captain of this team of five players [commercial supporters, medical education and communication companies, speakers, providers, and participants] because you are the ones who are going to be held accountable.
Attendee: The media recently reported that we've turned the corner on cancer. I read nothing about the contributions of the pharmaceutical companies or CME. Does anybody believe that this happened without any education? How many programs have we done on smoking cessation? Do you think that people just quit on their own? How many programs have we sponsored on colorectal screening? We're left out of the good stories, and we're only in the bad stories, but to a degree, that's our own fault. We don't have an action room somewhere, so when a story comes out, we hit back.
Pines: About correcting the record — that's a defensive posture, that's a reactive posture. You've got to create the rhetoric, and you've got to be very, very aggressive. Most people don't understand any of this stuff, so you've got an open slate there to educate [the public]. It's important to make violations public, as the panel has talked about, but you've also got to publicize the protective measures that are in place to [ensure] integrity. We've got to get to the people who matter, and educate key constituencies.
Joseph S. Green, PhD, has joined the American College of Cardiology, Washington, D.C., as vp for professional development and chief learning officer. He had been associate dean of CME and associate consulting professor, Dept. of Community and Family Medicine, Duke U. School of Medicine, Durham, N.C..
Maureen Doyle-Scharff, MBA, FACME, has joined Pfizer Inc. in New York as director, medical education group, U.S. external medical affairs. She was formerly with the Ross Products Division of Abbott Labs in Columbus, Ohio, where she served as director, health education.
Robert E. Kristofco, MSW, has joined Pfizer Inc. as director, medical education group, U.S. external medical affairs. Previously, he served as president, Meniscus Educational Institute, West Conshohocken, Pa.
Marcia J. Jackson, PhD, FACME has formed her own consulting company, CME by Design. Based in Santee, S.C., Jackson formally served as division vice president and senior advisor, education, with the American College of Cardiology
MELINDA STEELE, MED, director, CME, Texas Tech University Health Sciences Center, Lubbock, Texas
KAREN OVERSTREET, EdD, RPh, FACME, president, Indicia Medical Education LLC, North Wales, Pa.
MARK L. HORN, MD, MPH, senior director, worldwide medical policy, Pfizer Inc., N.Y.
NORMAN B. KAHN JR., MD, vice president, science and education, American Academy of Family Physicians, Leawood, Kan.
WAYNE L. PINES, president, regulatory services and healthcare, APCO Worldwide, Washington, D.C.