“In my company, CME is now considered too risky. We're pulling back,” said a participant at the Pharmaceutical Alliance for CME breakout session at the American Medical Association's conference on CME Provider/Industry Collaboration, held in September in Baltimore.
Many other participants said they are encountering similar concerns. When asked what the biggest barrier is to CME provider/industry collaboration, more than half of the approximately 75 participants responded: fear of compliance problems. In recent months, this fear has caused companies to go further than setting up online systems or centralized grant-approval committees — moves that caused delays and other problems for CME providers, as we reported in “The Frustration Factor” (March/April 2004). Now companies are questioning whether or not to fund CME at all. With nationally accredited providers alone bringing in $971 million in commercial support in 2003, according to the Accreditation Council for CME data report, this could spell disaster for CME providers.
“We've come to a tipping point,” says Michael Saxton, consultant and facilitator, CME Best Practices in Glen Gardner, N.J.; and director, professional development, University of Medicine and Dentistry of New Jersey. Saxton, who has 23 years' experience working in pharma firms, adds, “Companies are, or soon will be, fundamentally rethinking their role in transferring their research data to the medical community.” He predicts that even though commercial support levels have continued to increase to record levels, despite gloomy forecasts in the past, “now I think it will flatline at the end of 2004 and drop in 2005. How deep the valley will be, I don't know. But it will be a real shake-up to the system.”
REACTING TO REGS
While the Accreditation Council for CME's new Standards for Commercial Support, the PhRMA Code, and the Advamed Code, have had an effect, the real driver behind the system shake-up is the Office of Inspector General's pharmaceutical marketing guidance and the increasing number of government investigations — and hefty settlements paid by pharma. “The lawsuits and public scrutiny have had the greatest impact,” says David Bloch, an industry attorney and partner with Reed Smith in Washington, D.C.
In 2001, TAP Pharmaceutical Products shelled out $875 million to settle civil and criminal charges of illegally marketing and manipulating the costs of Lupron, its prostate cancer drug. Earlier this year, Pfizer dropped $430 million to settle charges of medical fraud in the promotion of Neurontin, a case it inherited when it purchased Warner Lambert. Experts expect many more investigations in the future. “I suspect you'll see more enforcement actions from the OIG if they find more bad actors in CME,” says Bloch, adding that any CME-related action would most likely be part of a larger inappropriate promotional effort, as happened in the TAP and Pfizer cases.
There is also increasing scrutiny at the state level. This fall, California became the first state to turn the OIG's pharma compliance guidance and the PhRMA code into law. A dozen or more other states may be considering similar measures, according to Rx Compliance Report, paving the way for state-level prosecutions.
OFF-LABEL OFF THE TABLE?
Because the Pfizer case charged that CME was used as a marketing vehicle for off-label promotion, some in the pharma industry are increasingly wary of CME, even though it has long been considered by the FDA and others to be a “safe harbor” for discussion regarding unapproved uses of drugs and devices. In fact, under the new Standards for Commercial Support, speakers do not need to disclose, as they did under the original Standards, whether they are discussing off-label uses.
Eric Aaronson, senior corporate counsel with New York — based Pfizer Inc., says, “Whether or not off-label discussion is allowable under therules is not the only question. A pharmaceutical company must consider whether a product discussed at a CME event could be the focus of an inquiry. The risk that the commercial support would be perceived as an attempt to promote a product off-label may have a chilling effect on a company's funding decisions for that product.”
One problem, he says, is that not all CME providers interpret the rules in the same way, are in a position to provide the same level of independence, or are in the same level of accordance with the ACCME rules. He sees pharma companies as having two potential choices: “Either they deal with fewer [providers] who they can independently confirm always abide by the guidelines, which may limit the breadth of [support] they provide and possibly reduce the overall amount of CME — or [companies can] still deal with a broad array of accredited providers who represent that they follow the guidelines, but [pharma will] steer away from funding meetings with topics that potentially could be perceived as attempts to promote off-label.”
But isn't that, in a sense, controlling the content by rejecting any activity that may have potential for off-label discussion? “Pharmaceutical companies should never say, nor should an ACCME-accredited provider accept one saying, ‘If you want funding, you will do x.’ On the other hand, pharmaceutical companies are not required to fund every request that is made of them,” Aaronson says. “We're not controlling the content if, before we agree to fund, we want to know the topics on the agenda. To make a funding decision, pharmaceutical companies do not need to know what will be said about each topic, just which topics will be discussed.”
Saxton cautions companies to be careful not to follow the letter of a regulation without understanding the spirit behind it. “If there's peer-reviewed, evidence-based literature out there — whether it's in-label or out-of-label — and pharma compliance policy tries to condition support on restricting a provider's use of evidence-based data that benefits patients, a company actually increases its risk. Many corporate compliance policies align with this view, and support decisions in favor of evidence that matters to patients. It is alarming, however, to see the number of companies that know so little about education that they're making decisions that put them at greater risk.”
The risk avoiders who do not understand education are most likely to reduce or eliminate their CME budgets, says Saxton.
FROM CRISIS TO OPPORTUNITY
“You could see the current situation as a crisis, or as an opportunity — as I do — to change the direction of CME from a vendor-based model to one that provides effective education that makes a difference in patients' lives,” Saxton says. “These regulatory issues are causing people to sit up and take notice that CME isn't a commodity or commercial product. The field has not been level. The industry has been rewarding some providers who were not good at education, instead of consistently rewarding those who are good at it. Now industry is paying attention to the quality of education, because it has realized this is the key to good compliance.” Once both pharma and providers really “get” that the real value of CME is educational, not promotional, industry dollars will return to providers who can supply CME where learning is not measured by the number of “butts in seats,” says Saxton.
“When we turn the corner to an outcomes-oriented model of CME that focuses on learning rather than teaching, I think CME support will increase above any level we've seen in the past. This is also the best way to improve compliance through the support of effective evidence-based CME activities. As long as we continue to go along with the butts-in-seats measure, dollars will decline, and ensuring compliance through such ineffective approaches is much more difficult.”
THE OUTCOMES DEBATE
But outcomes measurement can be a double-edged sword. Companies want to demonstrate the value of their CME investments; but they are concerned that data proving that CME changed physician behavior could be interpreted by investigators as evidence that CME was used as a marketing tool.
At a meeting of the North American Association of Medical Education and Communication Cos., held in conjunction with the AMA conference, participants were asked via an audience-response system how interested commercial supporters are in outcomes measurements. Sixty-nine percent said that commercial supporters want outcomes measurements, but they are not willing to pay for them; 23 percent said companies aren't interested. Only 8 percent said that commercial supporters both want and are willing to fund outcomes measurements.
But providers should not give up, said a pharmaceutical company executive at the PACME session. “Don't give them the option not to pay. Incorporate information into the proposal so they can't carve it out. Don't bury outcomes measurements in the proposal — showcase it. Measuring outcomes helps mitigate risk. If the OIG knocks on a company's door, it can show why it [funded the activity].
“It's like tough love,” she added. “If companies don't agree, maybe you shouldn't work with those companies. You're the education provider — you're accountable for the quality.”
IS SCRIP-TRACKING OFF LIMITS?
CME professionals disagree about what types of outcomes measurements will mitigate risk. Frederic S. Wilson, director of professional relations with Procter & Gamble Pharmaceuticals, Mason, Ohio, says, “Since ACCME Essential Element 2.5 requires that accredited providers measure the outcome of their overall CME programs, and since chart reviews are difficult and time-consuming, HIPPA implications notwithstanding, collaborating with a commercial supporter can easily produce objective measurement of participant practice application via the syndicated prescription data that most pharmaceutical companies purchase.”
According to Pfizer's Aaronson, the most useful data would be “what percentage of doctors who attended this presentation were more educated when they left than when they came in — not which physicians would prescribe more. Reliance on a prescription-based outcomes measurement could be used to show that the pharmaceutical company's decision to fund an event was driven by an attempt to drive sales, not education. That's not our intent so it would not be an appropriate measure of a successful program.”
Saxton says it's important to define outcomes as a way of improving compliance for pharma. “Outcomes, at the end of the day, will be a wonderful addition to compliance programs because they will provide [impartial] evidence that the appropriate needs-based behavioral objectives were met,” he says. “There's nothing about money going under the table or scrip tracking in that. Educational outcomes verify that we developed and implemented CME activities that focused on improving health care for patients. Nobody in that setting can ever accuse us of doing something inappropriate á la OIG. A good outcomes orientation will improve compliance, not undermine it. But I will hasten to add that there are not many providers who are good at outcomes yet — they're scrambling to get there. I think that's one of the big changes we're going to see.”
Another big change that is necessary is educating pharma about the value of CME. “[Cutting commercial support] does a disservice to the physician audience,” said the PACME participant quoted at the beginning of this article. “It's important that we argue that point. We need to follow the guidelines and be informed.”
Toward that end, PACME is developing a speakers bureau that will send CME experts to pharmaceutical companies, where they will speak with corporate attorneys, and regulatory and compliance staff to educate them about the value of CME. At press time, PACME's first presentation was planned for November.
In another effort currently under way, a group of pharma companies have agreed to work with the University of Medicine and Dentistry of New Jersey in a collaborative effort with the provider community. The objective is to develop competency-based training that targets performance and compliance improvement for industry personnel involved in a variety of positions with various levels of CME responsibility. While the program is still a work in progress, Saxton, who is involved in developing it, says the group will outline more of the specifics during the Alliance for CME meeting in January 2005. “We recognize that education has got to be one of the keys,” Saxton says. “It may well lead to certification of industry personnel involved with CME.” He adds that pharma likely will put out a call for this type of training for providers as well.
As a scientific affairs manager with a large pharma company, who prefers to remain anonymous, says, “It would be nice to have the CME [provider] have some sort of certification, or at least training. We've picked up on situations where there were errors in their processes, and we had to show them the ACCME guidelines and say, ‘Since we're [supporting] this, we don't want anyone to come back with an audit and end up biting us.’”
While government investigations target pharma companies for abusing CME, “we are in the situation not just because pharma has manipulated the system. We could not have done it ourselves,” said a participant at the PACME session. “Accredited providers are not doing their job.” Participants agreed that they needed more information about which accredited providers were compliant with regulations.
CHANGE — NOW OR NEVER
Saxton is not alone in cautioning CME professionals that they need to act now in order to preserve CME provider/industry collaboration. “There has never been a better time for accredited providers to take back complete control of this and start driving the need for analysis upfront and measurement on the back end,” said a pharmaceutical company participant at the AMA conference. “We have a window of opportunity and [we have to] seize this now and take advantage of the fear within the industry. Please help industry get together and move forward.”
“This time of change is uncomfortable for a lot of people,” adds Saxton. “The challenge is to embrace where we need to go, which is toward effective education that makes a difference in patient care, instead of regretting where we used to be. Conflict of interest and compliance issues are resolved best when we employ effective CME. Until we do that, there will always be questions about the relationship between CME and commercial support. Let's get there sooner rather than later.”
Reporting from the AMA conference on CME Provider/Industry Collaboration by Tamar Hosansky.
MECCs Under the Microscope
While pharma companies are reevaluating their relationships with all types of providers, MECCs in particular are under scrutiny. As Frederic S. Wilson, director of professional relations with Procter & Gamble Pharmaceuticals, says, “If you aren't from an academic center, hospital, or nonprofit, you're going to provide a wider potential risk because your motivation isn't the patient or the physician, it's profitability. As far as being the accredited provider, MECCs are going to be less attractive.” He predicts MECCs will work more closely with accredited nonprofits, medical schools, and hospitals.
David Bloch, industry attorney and partner, Reed Smith, Washington, D.C., doesn't see it going quite that far: “The main impact has been with regard to [pharmaceutical companies'] willingness to support CME through companies that also offer promotional services. I find that manufacturers have gotten a lot more demanding about the separation between the two.”
Michael Saxton, consultant and facilitator, CME Best Practices, Glen Gardner, N.J., says, “There are good and bad providers; I don't believe in stereotyping any particular group. The biggest solution to a lot of this is elevating the professionalism and knowledge of everyone involved.
“Good providers will survive this and eventually thrive,” he adds. “But there will be a lot of people who won't, and frankly, I believe there are a number of people who should go out of business, or at least get out of this part of the field, because they are not education-focused professionals.”
Improving Your Odds
OK, pharma companies are feeling very skittish about their involvement in CME. Here is what some in industry say would make them more likely to want to work with you.
Michael Saxton, consultant and facilitator, CME Best Practices, Glen Gardner, N.J., who worked directly for pharma before founding his firm, says that at least 90 percent of the provider account teams he saw were “what I would consider very unknowledgeable about CME. And increasingly, industry is paying attention to that.” Some suggestions: Know the basics, such as the difference between the Alliance for CME and the Accreditation Council for CME; have a good compliance program; and show how you incorporate good adult-learning principles into your activities. “It's not just about being able to fill out the paperwork. You have to be able to show that you think like an adult educator, not a vendor.”
While exemplary status with the ACCME is a good selling point, it is not enough, says Tracy D. Rockney, JD, executive director, professional education support, Wyeth Pharmaceuticals, Collegeville, Pa. “We want to understand how an accreditor accredits a program. We want to ensure that it is a robust process and not just a rubber stamp. There are accreditors that have ACCME exemplary status; however, our evaluation of some of their programs, as well as our evaluation of their accreditation process, has led us to not support their programs.
KNOW WHAT YOU CAN AND CAN'T ASK
According to Frederic S. Wilson, director of professional relations with Procter & Gamble Pharmaceuticals, Mason, Ohio, “The most important factor is supporting activities that are sponsored by accredited providers who understand ‘appropriate behavior,’ as described by the ACCME in the 1992 Standards of Commercial Support. Specifically, understanding that it's OK to request from a commercial supporter ‘assistance with educational planning’ and ‘assistance with preparation of educational materials,’ as long as the provider is watchful that the assistance not advance the specific proprietary interests of the commercial supporter.” Providers should “document that they have ensured that they made the final decision on ‘all things CME,’ and keep the enhancement of the physician's ability to care for patients the focus of their responsibility,” he says.
DON'T JUST TAKE THE MONEY AND RUN
A pharma company scientific affairs manager who prefers to remain anonymous says he values flexibility and communication. “Are they willing to at least talk with us, instead of just taking the money and running? We want to know if the activity is on target with anticipated attendance and if there are any logistical issues we can assist them with.”
TAKE THE MONEY AND RUN
“Don't ask us to do your job — even if it is only logistics,” says Eric Aaronson, senior corporate counsel, Pfizer, New York, N.Y. “The more distant the provider is from the supporter, the less we have to fear that the presentation will be seen as an attempt to promote our products. The less involved we are, the cleaner it is, and the safer it is.”
PROVIDE A GOOD NEEDS ASSESSMENT
“Data is powerful. Industry needs scientific research into real and perceived needs,” said one of the participants at the North American Association of Medical Education and Communication Cos. meeting in September. “We need to know who needs this education. Attorneys and regulatory people ask these questions. If data shows a [learning] gap that can be [corrected] with off-label info, a company then has the paper trail to show why [it funded this activity].”
“I've heard providers who for the first time are getting turned down because they didn't do a needs assessment very well,” adds Saxton, who underscores that the need must be evidence-based. Wilson says that his company is “most likely to support those therapeutic areas where we've done the needs assessment ourselves and know there are educational need gaps concerning diagnosis and treatment in the therapeutic areas where we're investing research and development.”
MAKE SURE THE ACTIVITY IS EVIDENCE-BASED, BALANCED, AND UNBIASED
“We're more likely to support evidence-based activities, and we expect providers we support would insist on it,” says P&G's Wilson.
“I think one of the most important things an accredited provider can do is demonstrate that all of the programs that they conduct, regardless of the supporter, are done in a balanced and unbiased fashion,” says Rockney. “I often send my team out to evaluate programs supported by other pharmaceutical companies. I want to know if the particular accredited provider is providing unbiased education.”
Wyeth is also working with providers to address potentialconflict-of-interest issues. “For example, when we receive a proposal, and the accredited provider indicates who their faculty may be, we are attempting to develop a system where we will disclose to the accredited provider if any of their selected faculty has any relationship with our company,” says Rockney.