“EVERYONE'S AFRAID,” says Janice Miller, director, CME, Brown Medical School, Providence, R.I. “Pharmaceutical companies have their legal departments working overtime to protect themselves from the threat of a huge, multibillion-dollar fine. I don't know if that was the intent of the OIG [Office of Inspector General's Compliance Program Guidance for Pharmaceutical Manufacturers], but that's the result.”
And they have reason to be afraid. In just this past year the industry has shelled out more than $6 billion in government fines for stepping over the line from marketing activities — including education — to violating fraud and anti-kickback laws. The OIG has enforcement power, adding clout to voluntary guidances like the PhRMA and AdvaMed Codes for interaction with healthcare professionals, and as a result pharma companies are restructuring their organizations to separate promotion from education. This means retraining their personnel and developing online and other centralized systems to take the perception of any wrongdoing out of the equation.
CME providers too are feeling the pain from all this reform in longer, legalistic letters of agreement and other forms, longer lead times in getting a grant proposal through the system, and the elimination of sales reps from the grant process. “We're working a lot harder for the same commercial support,” says Keith Dillon, director, corporate relations, with the American College of Cardiology, Bethesda, Md. “They're requiring things from us that they've never required before.”
Breaking Up Is Hard to Do
The revolution started when the voluntary PhRMA Code went into effect in 2002. “The PhRMA Code began to drive CEOs to really examine the process of commercial support, to look at what it was they were funding,” says Bruce Bellande, PhD, executive director of the Alliance for CME in Birmingham, Ala. After the voluntary assessment that code induced, these CEOs began to realign their thinking about funding — CME isn't about a party or a golf. Add to that the “CEOs' concern over bad press and the ever-declining public opinion of Big Pharma — which fell alarmingly low, alarmingly fast. That really put the message on their radar screens that they had to do something to build image,” he says. But, while the PhRMA Code was significant, “it pales in comparison to the turmoil the OIG guidance has caused,” he adds.
The main thrust of the OIG guidance is to reduce the perception of bias by truly separating sales from education, but from a pharma organizational structure perspective, breaking up is hard to do. According to Bellande, while the majority of CME funding is still coming from the marketing and research-and-development departments in the restructured companies, “there's now a good chunk of money going into the science or medical affairs department. Companies have had to train staff to work in medical affairs, or whatever they call that department, and now these people report to the science and education divisions, rather than the sales department.” It's a touchy situation, he adds. “The company has to be careful to ensure that, while the money's still coming from marketing, the disbursement has to come through an independent group not directly responsible for sales.”
Frederic S. Wilson, category manager CME, with Procter & Gamble Pharmaceuticals in Mason, Ohio, thinks this separation is an overreaction — and one that could have negative repercussions. “Because marketing controls the discretionary funding for the company's brands, if they can't have a voice in funding CME for a particular category or relevant disease, they could redirect that funding into other activities, such as direct-to-consumer advertising.”
Other types of changes also are in the works. For example, Alcon Laboratories in Fort Worth, Texas, now has its own compliance officer and committee to provide input concerning support for “questionable programs,” says Alcon's professional education director Carol Duke. In addition, she says, “We focus the majority of our dollars and efforts on high-quality CME events, and less on promotional programs, to ensure we are in compliance with all guidelines governing the pharmaceutical industry.”
Jacqueline Parochka, EdD, president and CEO of Excellence in Continuing Education, Ltd., Chicago, says that in addition to establishing multidisciplinary committees to review grant proposals, some companies have established education departments to review these proposals a second time. Some firms are awarding grants through the medical affairs department, and others are still awarding grants through the brand teams. At least four companies have put their grant-request process online, and many others require that all requests go directly to headquarters, bypassing the sales rep entirely.
In fact, first nationally, then regionally, many companies over the past year or so have been cutting the sales rep and other marketing/sales/promotion personnel out of the process, either by putting the granting process online, or through a designated central committee or department at headquarters. While providers used to collaborate with sales reps on CME activities, “You can't even call your usual contacts now,” says Miller. “They say it's coming from upstairs.”
We Miss Our Reps
“We're missing the opportunity to interact with the sales reps,” says Lynn Thomason, MLS, director, CME, University of South Dakota School of Medicine, Sioux Falls. “We can't even have them say that we do a good job and that they recommend us, that our work and experience with them has been a positive thing. Their input is no longer permitted, and I wonder who really ends up being at risk when things are so impersonal.”
Wilson agrees that taking the rep out of the process is not a good idea. “I don't understand the histrionics,” says Wilson, whose company hasn't made any significant changes in its process, other than to continue to reinforce its training efforts for reps in the field. He poses a situation where, for example, “an application might be turned down by a major pharmaceutical company because the name of the hotel sounds like it is a resort, when in reality it is a Holiday Inn. The local rep would know that.” He believes the sales rep is vital to the process in other ways as well: “They are in the best position to contribute input to the needs assessment process — they have the most accurate and detailed understanding of the diagnostic skills and treatment proficiencies of the physicians in their territories. That input has now been completely cut off.”
While some of the larger CME organizations are able to retain their direct connection to their higher-up contacts, “there are an awful lot of organizations that don't have that connection, and their only way in was through the reps,” says Jann Balmer, PhD, director, CME Office, University of Virginia, Charlottesville. Of the impersonality of online proposal systems, Thomason says, “We feel there's a much higher level of trust that can be accomplished between two people than could ever be developed between a provider and a Web site.”
And the tough sell has definitely gotten tougher. “This tears the guts out of providers like me,” says Linda Wilhelm, whose education and organizational development department with Floyd Medical Center in Rome, Ga., is having a difficult time getting support for a spirituality in healthcare presentation. “Our program doesn't fit into an easily identifiable slot. In years past, some of my loyal sources of support could stretch their budgets and criteria to be able to give a grant for something that's not 100 percent product-related. All this has put fear into supporters, unnecessarily so when they're dealing with legitimate CME.”
Letters and the Law
Now that lawyers are running the show, official communications are changing, too. “For the first time, someone asked me if I would rewrite my cover letter to their specific requirements,” says Wilhelm. “My standard letter began with, ‘Thank you for your willingness to provide an educational grant for this activity.’ Now it had to be worded, ‘I am officially requesting an educational grant.’ Now the letter sounds like the first contact we've had about the activity, instead of acknowledging that we've talked with a rep previously and reached an agreement on what the grant and the activity will be. It was a coverup, but fortunately it wasn't anything that would impact the integrity of my letter.”
But the cover letter is nothing compared to the contortions people are going through with the new, more complicated, lawyer-generated Letters of Agreement, or LOAs. “Companies are opposed to accepting others' LOAs or having theirs amended in any way,” says the Alliance for CME's Bellande, who points out that this is not just a provider problem. “It's frustrating for those who are trying to disperse the funds to deal with this. On one side they have providers asking if they can amend [the LOA], on the other they have legal saying ‘No.’ It's causing some real difficulty.”
But Balmer says it's definitely worth trying to amend language in a pharma LOA if it contains something that goes against your organization's policies. “It shouldn't be a one-way agreement,” she says. “There are a lot of providers who don't think they can make any changes to the letters, but they should agree to only what their organizations [are comfortable with].” For example, she will not sign any letter that asks her to agree to abide by the laws of any state other than Virginia. “As a state institution, we never [want to] have a situation where we are held accountable for the laws of any state other than ours. This is supposed to be a partnership, albeit one at arm's length. You have to be respectful of the other person's position, but that doesn't mean you relinquish control.”
Thomason says that while no one wants to spend the time and energy to change wording, “I take the time to cross things out — it takes more time than I wish out of my day — but it's necessary. And I've never lost an event or a grant because of it.” Dillon says his organization has had to be “smarter internally in how we go through the process. We try to get our solicitations for grants out a little earlier than we used to” not only because some back-and-forth on wording might be needed, but also because some companies' grant review committees meet only once a month, “so if we miss this one, our next opportunity isn't until next month.”
Inconsistency, Thy Name Is Pharma
“Some of the mistakes that have happened in the past are a result of the way the industry is configured,” says Parochka. “The companies more or less can't talk to each other, which makes it difficult for them to maneuver effectively when something like this comes to pass. Everyone is working independently, which ups the difficulty for accredited providers exponentially.” Dillon says the inconsistency has been a challenge for him as well. “It puts the burden on us to have a clear understanding.” (See sidebar on page 38 for his tips on dealing with this.)
Ultimately, if the lawyers continue to drive the process, Parochka thinks more CME program officials will turn to their own legal counsel for document review and sign-off. “It will be safer for everyone concerned if attorneys deal with each other and leave educators to what they do best.” Or perhaps all the compliance departments for pharmaceutical and medical device companies could reach an agreement on a standardized LOA?
Not going to happen, says P&G's Wilson. “The National Task Force on CME Provider/Industry Collaboration formed a working group to resolve this issue. Very early on, I said I didn't think it would be possible. The guidelines — whether they're the 1992 Standards for Commercial Support or the 2003 OIG guidance, contain too many gray areas that require interpretation, and each company's lawyers are going to interpret them differently. Consequently, you're going to have different LOAs.”
Dillon thinks part of the answer is education. One of ACC's subspecialty groups recently held a meeting for medical device manufacturers that was led by representatives of AdvaMed, a device industry association that last fall released its own ethical guidelines for members. “Even within the fairly narrow niche of companies that make electrophysiology devices, the understanding of the AdvaMed Code went from one end of the spectrum to the other,” he says. “AdvaMed's CEO gave a presentation on the origins of and the spirit behind the code, and an attorney from Arnold & Porter interpreted how the code relates to their dealings with medical societies. It made a big difference in reconciling all the different perspectives these companies' representatives had.”
For Whom the Pendulum Swings
While the CME enterprise has seen the commercial support pendulum swing from one extreme to the other, usually coming to rest somewhere in the middle, consensus is that this time it's not swinging back toward a more lax attitude. “I think it will continue to intensify,” says Bellande. “Self-regulation would have been a good way to protect yourself and survive — and the PhRMA Code was an attempt to do that. The problem was that the code came too late; the horse had already left the barn. With $500 billion dollars in Medicare prescription drug benefits on the line, all the media needs to say is, ‘Let's look into how the federal government's money is being spent by Big Pharma,’ and you're likely to see even more external regulation.”
And the revolution still has a ways to go within individual pharma companies, too. “Everyone I talk with says it's all still a work in progress. It's going to take a while to shake out,” says Balmer.
There Is an Upside
But while the brave new world of commercial funding may be a chaotic, ever-changing hassle right now, it isn't all bad. “The good news is that all this has caused companies that had perhaps not been paying attention to what they were doing with CME to take a look at what was going on and establish policies where they had none before,” says Wilson. He adds that it has also caused companies to revamp their training in both CME and gifts to physicians policies, and also feels it's positive that PhRMA is being more proactive. “They've never had much interest in CME in the past,” he says.
Another plus, says Dillon, is that, “generally, companies are trying to find ways to be compliant, not ways to work around the system.” Adds Duke: “For the most part, the results have been positive for companies that have taken the high road. It has reinforced our commitment to quality, fair, and balanced educational programs.”
Even the online granting systems, which providers say still have some glitches, at least ensure that your approval comes back with a signed LOA, eliminating the need for providers to track down someone to sign an incompletely signed letter, says Miller. “I think you're going to see these systems get much more sophisticated,” says Bellande. “Now they're mostly administrative, quasi-legal applications, but companies are going to realize this is where they need to determine if the quality of the activity will achieve the desired outcome. They're not there yet, but I think that's where it's going.”
And there's still much work to be done. For example, says Duke, while physicians, CME providers, and industry will become more accustomed to doing business under the new guidelines, making the process easier for everyone, “We are finding that the CME providers and industry, for the most part, know the guidelines, but the physicians don't.” Dillon agrees that “we still need education targeted to healthcare professionals outside of CME. There are a lot of people in the healthcare industry and the legislature who don't have a good understanding of the process and how it differs from FDA-approved on-label promotion.” Dillon recommends that medical societies step up to the plate and develop training programs to educate members on the guidelines. “PhRMA and AdvaMed are reaching out to medical societies and other organizations to help teach physicians what the guidelines mean to them, too, so they don't push the envelope in their relations with a company.”
Bellande sees even bigger changes on the horizon, namely the entire mind-set of the pharmaceutical industry toward CME. “The mentality of justifying the funding by considering CME as a way to promote a product has to change,” he says. “Companies have to realign their view of education as a strategic resource that is both a way to increase the appropriate prescribing of drugs for certain conditions, and a way to improve the public image of Big Pharma. I think companies will look at their goals and values from a strategic perspective, then determine how education can help the company achieve them.”
“Pharma and CME providers are all trying to figure things out in this new environment,” says Thomason. While she says that “one bad experience right now is worse than at any other time, because the spotlight is on us,” she says the spotlight also can increase awareness of all the good that can come out of the partnership. Adds Balmer, “We have a real opportunity here to shine the light on the important things, the fact that CME providers and commercial supporters are all moving toward positively impacting physician behavior.”
The MECCs Effect
Medical education and communication companies are seeing another potentially huge impact of the restructuring of the pharma industry. The pharmaceutical companies “are deciding to award MECCs (defined as companies that produce both certified CME activities, if accredited, and promotional activities) grants for either CME or promotion, but not both,” says Jacqueline Parochka, EdD, president and CEO of Excellence in Continuing Education, Ltd., Chicago, who also is past-president of the North American Association of Medical Education and Communication Cos.
In fact, NAAMECC recently surveyed its members on the impact of this trend on their businesses, and found that 22 percent made the decision to create a separate company for CME in the past year, and an additional 26 percent plan to do so in the future. Nine percent plan to phase out CME. Factors behind their decisions to change the configuration of their companies include a client directive to fund either promotion or CME activities (29 percent), and a client directive for separate promotion and CME account teams (19 percent). However, 70 percent said they plan to retain their Accreditation Council for CME accreditation.
“Communication companies are going to have to make the internal decision on whether or not to create in-house education companies to ward off the appearance of a combined promotion and education unit,” says Parochka. “Some will decide to do only education or promotion. Eventually, I see the definition of education companies, as opposed to communication companies, becoming clearer.” While the transition period may take a while, “That's the way I see it going. They're not going to lose out on business just because this regulation comes along; they'll figure out how they're going to maneuver in the new system.”
Advice from the Field
“If a Letter of Agreement comes in from a company we haven't worked with before, we do an almost word-for-word comparison against the language in our LOA documents. If there is anything that we're not comfortable with, we send it out for legal advice. Then we negotiate any changes and ask the company to use the same letter in the future so we can have consistency, or to flag any changes in future letters. That way, we cut down on the amount of document review we have to do.” — Keith Dillon, director, corporate relations, American College of Cardiology, Bethesda, Md.
“Be much more aware of companies' funding cycles and how those relate to budget, and who will be reviewing the proposals. Be prepared to provide more than just the usual administrative details.” — Bruce Bellande, PhD, executive director of the Alliance for CME in Birmingham, Ala.
“We are very diligent in reviewing grant requests and requests for supporting CME programs. We have specific criteria we are looking for, whether for CME or nonaccredited programs. We want a written letter of request designating the purpose of the grant, a program agenda if available, and follow-up information on the number of attendees and summary of the evaluations — we review these to determine our future support of the requesters' programs.” — Carol Duke, professional education director, Alcon Laboratories, Fort Worth, Texas
“Keep reading industry publications, keep dialoguing with your colleagues, keep attending professional conferences. If you're not a member of a professional organization, join, because these organizations can provide legitimate and timely information.” — Jacqueline Parochka, EdD, president and CEO of Excellence in Continuing Education, Ltd., Chicago
“Just suck it up and deal with it, and try not to shoot yourself in the foot.” — Janice Miller, director, CME, Brown Medical School, Providence, R.I.