Get ready to prove yourself. Pfizer's new CME team demands grantees meet high standards of compliance and education. And MECCs need not apply.
Imagine proposing to your higher-ups that they eliminate your department. That's what the Pfizer CME team did last year.
With government, public, and media criticism of pharmaceutical industry support of CME intensifying, the Medical Education Group decided it was time to step back and do a strategic analysis of their future role. During the previous few years, the group's leader, Mike Saxton, had put together a team of CME leaders drawn from a diversity of backgrounds — including the academic, association, and hospital sectors. This team took a hard look at the risks and benefits of funding CME.
They decided that maintaining the status quo was unacceptable. The next option was to eliminate funding entirely, which would certainly help with the perception and risk problem — but would remove their ability to contribute to healthcare improvements through supporting independent education. Another choice was to adopt an entirely new approach: develop stricter eligibility requirements for CME providers and award grants only to education that would actually make a difference in patient care. The team recommended those two options to company execs.
“We felt so passionate about it that we literally put our jobs on the line. If our company had supported [eliminating commercial support], we'd be closing up our shop,” says Mike Saxton, Med, FACME, senior director, team leader, Medical Education Group, U.S. External Medical Affairs, Pfizer Inc., New York.
Fortunately for the group, the leadership at Pfizer gave the go-ahead to create a completely new model.
Launched in January 2008, the new approach has three major goals: to fund only providers that meet Pfizer's standards for compliance and independence; to support performance-improvement education that results in measurable changes in physician behavior and patient care; and to redirect resources from national programs to local and regional initiatives. The team, whose budget comes from medical affairs, says the system is a work in progress. In fact, on July 2, as we were getting this article ready for publication, Pfizer announced a major change: medical education and communication companies would no longer be eligible for grants. (See sidebar, page 25.)
To address their first goal, the group created a CME Web portal with a provider registration process. Only CME departments or those individuals who are ultimately responsible for education within their organization are allowed to register. One purpose is to prevent applicants from skirting the system. For instance, non-accredited organizations cannot get a grant and then “shop” for a provider. Pfizer holds the accredited provider that registers in the system responsible for the actions of its educational partners.
The process also ensures that the right department within an organization is in charge. “Sometimes, at a hospital or academic medical center, for example, an individual department or an important physician will get a grant, set up the agenda, and then go find the CME department and say, ‘I need credit for this.’ The provider walks a very fine line managing that situation and that relationship,” says Maureen Doyle-Scharff, MBA, FACME, director, Medical Education Group, U.S. External Medical Affairs, Pfizer Inc. “We are seeking to empower providers so that they can do their job.”
Rated on Risk
In the next step of the registration process, providers are asked questions to assess their level of independence, compliance, and professionalism, such as: Do you have a mechanism to resolve conflicts of interest? Do you have a content validation process? Does your staff undergo professional development training in CME? Are you or is anyone on your staff a member of a CME professionals' organization such as the Alliance for CME or the Society for Academic CME? As well, applicants are asked to include any history of noncompliance with Accreditation Council for CME requirements.
To evaluate the registration request, the team uses a score card with about 30 items; each one is assigned a risk score. Providers that request 100 percent of an activity's funding from Pfizer are perceived as more risky than those seeking grants from multiple commercial interests, as are organizations that receive 100 percent or close to 100 percent of their revenue from industry.
The team members not only assess the provider's responses — they also look at seemingly innocuous things such as: Is the applicant sending the form from a personal e-mail address? “That sounds simple, but we have found that about half of the people applying from a personal e-mail were higher risk. There's a reason they weren't using a business e-mail,” says Saxton.
The team excludes about 10 percent of the providers that apply for eligibility, says Saxton, usually because of independence issues. And while the team's questions reflect similar values to the's, their assessments don't always align with a provider's accreditation record. “We have excluded organizations that are accredited with commendation,” he says. “On the flip side, organizations with lower levels of accreditation may be more compliant.”
Each team member is responsible for reviewing grants within certain therapeutic areas. While they are individually empowered to approve providers, there is a team review to make a final decision before ruling an applicant ineligible. As with other aspects of the CME process, the score card is evolving; there have been four different versions this year. Pfizer hopes to publish the evaluation criteria in the future.
The rest of the grant approval process depends on the dollar level. Grants under $25,000 can be approved by the team; those between $25,000 and $250,000 are approved by the MEG team in collaboration with their medical affairs colleagues. Grants above that amount also must be reviewed by the regulatory, legal, and medical affairs departments. The Medical Education Group conducts a quarterly retrospective review of all grants, whether they were for $500 or $5 million.
So far, the team members say, they've gotten positive feedback from providers on the new system. One major plus: Organizations have to register only once and update their information annually. They can then apply for multiple grants. However, there was a learning curve involved, as some people weren't sure which departments within their organizations handle CME. “Some institutions have intricate structures with no centralized CME/CE departments and are accredited through a partnering medical school, for instance.” says Sarah Krüg, director, Medical Education Group, U.S. External Medical Affairs, Pfizer Inc.
There have been providers who have bristled at the questions about how much industry funding they receive. Calling that attitude “an entitlement mentality,” Doyle-Scharff says, “If you don't like the questions we're asking, that's fine. You don't have to request funding from Pfizer, just as we're not obligated to provide funding to anyone.”
Back to the Trenches
The team's second and third goals — funding quality-improvement CME and supporting local initiatives — are linked. Aiming to support educational initiatives that meet the ACCME's criteria for Level 3 accreditation, Pfizer is reducing funding for traditional activities like one-off conferences and live lecture formats, and it is shifting funds to performance-based initiatives, such as an educational series that includes a live event followed by a monograph and quality-improvement tools.
“The really good education that's tied to a true quality-improvement model is not happening in the one-size-fits-all mass national education activities that are often produced by medical education companies and major academic medical centers,” says Doyle-Scharff. “They say all politics is local; so is medicine.”
“National initiatives can make a difference but with a regional or community approach, you are more likely to address local needs, identify regional barriers to care, and provide effective educational interventions,” adds Jacqueline Mayhew, director, Medical Education Group, U.S. External Medical Affairs, Pfizer Inc.
And those community-based programs have been squeezed out of funding in recent years, says Saxton. When companies moved to centralized, impersonal online grant systems in response to the regulatory environment, the goal was to prevent industry from influencing education — but there were negative side effects. Providers' long-term relationships with their local industry sales reps and medical science liaisons were severed. They had no one to turn to if they had questions about seeking funding, and there was a drop in support for regional providers. In fact, according to the ACCME Annual Data Report 2006, local providers get only about 3 percent of the total commercial-support pie yet they produce more than 35 percent of the education. “We have created a system that is not democratic,” says Saxton.
Pfizer's new process aims to redress those issues. Each team member is responsible for a particular region (in addition to their therapeutic areas). Their role is to offer providers face-to-face contact with grantors, facilitate discussions about public health issues, and encourage providers to collaborate with each other and with others in the healthcare community, a direction that aligns with the ACCME's Level 3 accreditation criteria.
“I might meet with different providers within the same state who may not be talking to one another but might be trying to tackle the same thing,” says Doyle-Scharff. “I can say, ‘What do you think about coming together? By bringing together your individual strengths, you could really tackle this on a statewide level.’”
The team members express excitement when discussing the regional approach. “It is very rewarding to be able to meet with regional CME providers who are tackling the needs of the healthcare professionals they directly serve and be able to encourage them in their work,” says Mayhew. “It has been important to provide a personal face to Pfizer grant support instead of just a centralized New York office.”
“It's always nice to work where your heart is,” says Robert E. Kristofco, MSW, director, Medical Education Group, U.S. External Medical Affairs, Pfizer Inc. “I value being able to provide educational support to practitioners at the local feet-on-the-ground, in-the-trenches setting where healthcare is practiced. Jackie [Mayhew] and I can talk about cardiovascular issues that relate to the South, and we can talk about the things folks are doing in her region in terms of pain management.” One of the things that attracted him to Pfizer was the opportunity to do more than sit at a desk and manage money. “This is much more than a transactional kind of experience,” he says.
Guarding the Boundaries
But isn't opening up interaction between supporters and providers risky from a compliance standpoint? Conversations are not about individual activities and content, as that would be inappropriate and violate regulations, the team members say. “We find that with the better providers who are focusing on performance-improvement education, there's no ambiguity; we're all clear on the boundaries,” Saxton says. “There are occasions when providers reach out to us with explicit questions and content-related issues. Then, we are the ones saying, ‘We can't have this conversation.’”
He cites one example that occurred within the week of our June interview where a provider contacted him, implying that Pfizer would have an interest in a monograph about one of its new drugs based on a presentation at an upcoming meeting. “That's a black-and-white issue; there are some a little more gray,” he says.
The problems are not usually with regional providers, he says, but are more typical of national-level providers or non-accredited MECCs. If the team believes the inappropriate behavior was intentional, they may exclude the provider, and they certainly will deny any grant associated with the conversation, Saxton says. If the problem is with a nonaccredited MECC, the team tries to find out who its partners are to identify accredited providers that might rubber-stamp proposals.
“There are some providers of every type that are still too lax in their oversight of joint sponsor arrangements,” says Saxton. “Sometimes the provider doesn't realize that kind of conversation occurred, but it still demonstrates the provider is not in control of the joint sponsor arrangement.”
Saxton says a group of CME professionals from industry are meeting with the ACCME to discuss ways for pharma companies to report providers that may be acting inappropriately.
The 50 Percent Solution
One of the Medical Education Group's next goals is to determine a commercial-support ceiling for providers. They're currently considering excluding providers that earn 80 percent or more of their income from pharma grants, beginning in 2009. Going forward, Saxton believes that it's appropriate for providers to receive about 50 percent of their funding from the pharmaceutical industry. “Balanced funding is not a new idea,” he says. “It's time that we in industry do our part to encourage it in a way that is respectful to providers.”
Providers should diversify their funding sources, the team members say. “I think it should be very rare that an initiative is fully funded by one commercial interest,” says Mayhew. “Multi-company support, grants from foundations or the public sector, [and] physician registration or participation fees are all important.”
There have been dire predictions in recent years about companies drastically reducing or cutting off CME funding. In fact, Pfizer's CME funding decreased in 2008 from 2007 levels, although not substantially. That's not necessarily a bad thing, says Doyle-Scharff. “If we don't support education that's not providing an appropriate impact, that might mean we don't need [as much] money,” she says. “We're not trying to protect dollars. We want to be smart about it.” Being smart means funding education that yields data demonstrating its effectiveness in improving patient care, she says.
Saxton foresees that pharmaceutical companies will make big cuts in funding in the near future, but he remains optimistic. “We have reached that tipping point — we have to either fundamentally change the commercial-support system or it's going to go away,” he says. “I still believe that the golden age of commercial support is in the future. If people judge [our success] by how many dollars are in the system, then the golden age is in the past. But if they judge by the contributions commercial supporters make to patient care, then the golden age is absolutely in our future.”
Focus: Educational quality and leadership
Background: 25-plus years as a CME professional in the pharmaceutical industry, with companies including Wyeth and Pharmacia, before joining Pfizer in 2006
On industry funding of needs assessments: “Commercial supporters should fund needs assessments and put all the results in the public domain. We should not fund three or four and cherry-pick the one we happen to like.”
Region: Northeast, international
Therapeutic area: Oncology
Background: Clinical research. Joined Pfizer in 2001; previously worked for Memorial Sloan Kettering
On global CME: “I don't believe that it's crucial that CME/CE credits be reciprocal between countries, as each country has very different standards. Global relicensure of one's professional degree should be mandatory and contingent upon demonstration of continuing professional development.”
Robert E. Kristofco
Therapeutic areas: Neuroscience, chronic pain
Background: 19 years as associate professor in the division of CME, University of Alabama at Birmingham. Did a short stint as president, Meniscus Education Institute, before joining Pfizer in 2007
On moving from academia to industry: “My view of the commercial supporter was somewhat naïve. There are a great many complexities to the grant-making process. I'm clearer now about the adage about walking a mile in someone's shoes.”
Therapeutic area: Infectious disease
Background: 18-year CME veteran, serving companies including the Upjohn Co., Pharmacia, Johnson & Johnson, and Abbott Laboratories, before joining Pfizer in 2007
On creating balanced funding standards: “The Alliance for CME needs to tackle balanced funding. It's the only organization that represents every stakeholder. The collective CME community can have a conversation about [funding] standards, and commercial interests should sit at the table.”
Therapeutic areas: Cardiovascular, metabolic, urology, and respiratory
Background: Prior to joining Pfizer in 2006, served as director of continuing professional education for the American Heart Association
On why she switched from the provider side to industry: “By being in a position to award grants to CME providers who adopt the ACCME's new criteria, I can make the most difference in improving CME and patient care.”
MECCs Need Not Apply
In a move certain to spark great controversy in the CME community, Pfizer announced on July 2 that it will no longer award grants to medical education companies.
“We are eliminating support for commercial CME providers, whether they are for-profit or nonprofit, and regardless of whether they have firewalls,” says Mike Saxton, Med, senior director, team leader, Medical Education Group, Pfizer, New York. “Our intention is to send a signal that funds must be used exclusively for independent education.”
Up until this announcement, Pfizer had awarded 17 percent of its CME funding to medical education and communication companies in 2008. “That figure will now drop to zero,” says Saxton.
He clarifies that this move is not a blanket condemnation of medical education and communication companies. “Some of the best providers out there are MECCs — and some of the worst are MECCs — so it is unfortunate that this action will not allow us to give direct support to quality MECCs,” he says. Pfizer will continue to fund CME initiatives that involve MECCs, he says, as long as they're not the primary sponsor.
“MECCs' role is critical. Patients would clearly lose if MECCs were not part of the equation. They're innovative, they're efficient, and they have competencies that other provider groups often lack. The best model for MECCs is to collaborate with hospitals, associations, and academic medical centers.”
Follow the Compensation
Pfizer is making this move, Saxton says, in part, because of the widespread perception among the healthcare community and the public that MECCs blur the line between education and promotion.
In addition, Saxton says Pfizer is extremely concerned about some MECCs' business practices, whether they are for-profit or nonprofit, particularly their use of business development personnel who are compensated financially based on the amount of funding they bring in. This can motivate people to cross ethical lines in order to please grantors, Saxton says. The CME team has tried to screen for MECCs that use such a business development model, but without success.
“We've made what I consider a Herculean effort to ask questions on our new application to get at these issues and it simply has not worked,” says Saxton. “We've been disappointed and frustrated by our inability to get verifiable data. We do not have a way to be certain that the data is accurate; in fact, we know in some cases it's not accurate.
ACCME: A Minimum Standard
Pfizer's exclusion of MECCs includes those that have developed firewalls between their marketing and educational arms, even those that are or will be approved under the ACCME's new policy, released in August 2007, which requires MECCs to alter their corporate structures so that they are completely separate from sister companies involved in marketing. (MECCs whose parent companies are redefined as commercial interests are no longer eligible for accreditation.)
But Saxton says the business development practices Pfizer is concerned about “create an irreconcilable conflict with independence that is not currently addressed by the ACCME system at all. The MECC community will appropriately point out that as a group they're more in compliance than other provider groups, but noncompliance findings are often for relatively minor issues involving paperwork and ignore more fundamental conflicts of interests that aren't even being looked at or discussed. As the accreditation system becomes less paper-driven and more outcomes-driven, then the ACCME's data will be more relevant to this discussion. Today, it is only one piece of information and we know it is not sufficient. It's a minimum standard.”
Saxton acknowledges that there are independence issues with other provider types, but says they're not as institutionally ingrained as they are with MECCs.
“It doesn't mean that we're ignoring conflicts of interests in those other settings. We have excluded providers in every setting for some of these same reasons, but the issue was just not on the same level of magnitude.”
To comment on this development, please send e-mail to Tamar Hosansky at firstname.lastname@example.org.
Getting Grants: 3 Tips
In addition to encouraging providers to focus on performance-improvement initiatives and collaboration with other organizations, the Pfizer CME team offers these pointers for putting together a grant proposal.
Start with your mission. “If a CME provider is applying for a grant and they start with, ‘Oh, Pfizer has funding available on smoking cessation, so let's come up with a smoking intervention,’ and then they come up with an activity, and they go backwards a step and write up objectives, and then they go backwards a step and do a needs assessment, then it's obvious the activity is not driven by a mission to improve healthcare quality,” says Jacqueline Mayhew, director, Medical Education Group, U.S. External Medical Affairs, Pfizer Inc.
Account for all your costs, including staff time. In several cases, Pfizer has awarded small $10,000 grants to associations for an annual meeting, and subsequently the organization raised enough through other grants and registration fees to cover the costs as delineated in their budgets. Pfizer then asked for the money back. “The [association] hadn't taken into consideration that they had three full-time people working all year on that meeting,” says Mayhew.
Get funding in stages. “It is fine to think about an educational intervention in stages and seek funding along the way,” says Mayhew. “We have given grants just to support a needs assessment or planning phase. We can also award grants just for an outcomes-assessment project. Grants do not always have to be for the education intervention itself.”