No one seemed to see it coming when, just after Labor Day, the Accreditation Council for Continuing Medical Education dropped a bomb on the CME provider community in the form of 22 new accreditation criteria. “The ACCME has been talking about it for a long time, but no one knew what form it would take, when it would come, or what direction it would go in,” says Jann Balmer, PhD, director of CME with the University of Virginia School of Medicine, Charlottesville. “Now we know.”

To achieve Level 1 (provisional) or Level 2 (full) accreditation under the new criteria, which go into effect in November 2008, CME providers will have to revamp their mission statements to focus on education that improves physician competence, performance, or patient outcomes. They also need to design educational interventions that can live up to those mission statements, and to continually improve their CME programs. To meet Level 3 (accreditation with commendation) requirements, they also have to integrate CME into practice improvement, address barriers to physician change, and participate in quality improvement — all of which asks providers to take on components of the healthcare system that traditionally have been outside the purview of CME. (For a full listing of the 22 criteria, along with supporting documents and FAQs, go to accme.org.)

Once the shock of those 22 criteria virtually thudding into their in-boxes began to wear off, most CME providers seemed to approve of the new accreditation requirements — at least in principle. Robert Addleton, EdD, director of education, Medical Association of Georgia, Atlanta, speaks for many when he says, “The ‘quality movement’ has been active in healthcare since the late 1980s. This document is the first time that CME has been identified as an integral partner in that movement. The success metric is being shifted from numbers of activities, attendance, and the paper trail to the impact on physician learning and even patient outcomes. How refreshing.”

Why then, as providers talked about the new criteria at the National Task Force on CME Provider/Industry Collaboration conference in Baltimore a month after the documents were released, were so many saying things like, “It's time for me to start thinking about my second career as a Wal-Mart greeter,” and even contemplating which nonessential organ to schedule for removal so they can be out on medical leave when the ACCME surveyor next comes to their office?

The Gray Zone

As is often the case with ACCME's newly released documents, the criteria for accreditation contain a number of gray areas. For many providers, the lack of specificity, coupled with the November 2008 deadline for implementation, are causing great angst. Byron Roseman, MD, director of medical education with Lowell General Hospital in Lowell, Mass., for example, finds criterion 19 (“The provider implements educational strategies to remove, overcome, or address barriers to physician change”) to be too vague to implement. And he doesn't see any difference between criteria 20 and 21, which state, respectively, “The provider builds bridges with other stakeholders through collaboration and cooperation,” and “The provider participates within an institutional or system framework for quality improvement.”

“A two-year implementation is not a long time for 22 criteria, and the anxiety comes from much of this not being clearly defined yet,” says Balmer. She points out: “On a good day, there are things that would take a good two years to get your head and hands and program around.” Because her organization is coming up for reaccreditation in 2009, she says, “I don't have the luxury of waiting. I'm going to give it my best guess and hope I'm right. Even if I don't have the GPS points laid out, I know I have to go north, and I'm going to ask everyone I run into along the way if they know a better route.”

The ACCME has stated that it doesn't expect full compliance with all 22 of the new criteria until 2012, but that it does want providers to show progress as of the November 2008 cycle. (See the list of FAQs at accme.org for more details about ACCME expectations.) But providers still have many questions, including how much of their program needs to be compliant to get a passing grade for reaccreditation.

Kurt Boyce, president, Global Education Group, Rutherford, N.J., on the other hand, says he has no problem with the document's ambiguity. “As for clarity, I suppose the criteria can be perfectly clear to any two CME professionals, but they may not agree on exactly what any particular criterion means. Thus, we will have a situation much like what we find today: Different groups developing different methods to comply. This is as it should be. In the past, ACCME has been very receptive to this diversity. Also, it is important to note that ACCME is concerned with a provider's process as well as its results. This allows for trial and error.”

Is It Worth It?

Even for providers in hospitals, who already have the potential to be in the quality improvement loop, the criteria can look like a whole new pile of work. Says Roseman, who is no fan of the new criteria, “The added burden, expense, and frustration may cause some providers to leave the industry.” And he may be right. It's particularly daunting for those who are already strapped by limited resources, small staffs, and shrinking grant dollars.

That's the case for this CME manager with a hospital in the Midwest, who asked to remain anonymous. “After looking at the new criteria, I said to myself, ‘We have met the enemy, and he is us.’” She says she just can't face the idea of revamping her system to align with the new criteria.

“We just finished reworking our whole process, and we received exemplary [accreditation] in every area. We have everything up to speed and we are doing everything we can with the resources we're given. We just don't have the resources to go into every physician's charts and track what happens after an educational intervention. The way the new criteria line things up, we could go from exemplary [accreditation] to provisional in the blink of an eye. I am ready to turn in my retirement papers — sometimes you come to a place in your life where it's just not worth it.” She adds that she can see some of the smaller institutions giving up on CME altogether because they lack the resources to implement the new criteria.

On the other hand, Linda Caples, continuing medical education coordinator with Waukesha Memorial Hospital, Waukesha, Wis., says that while she initially questioned whether she had the resources to make it all work, she found that her hospital, like many, already has quality improvement initiatives and is tracking physician performance improvement — just not in the CME office. As she attempts to get CME into the loop of quality improvement, she says her goal is “to find a system of communication that's not going to burden everyone involved. There is a team in place already. I don't have to do the chart reviews, I don't have to get the articles, I don't have to send them out, and I don't have to do the [post-activity] review. I do have to draft the evaluation and close the loop, but once that is established, we should be good.”

Caples says it may not be as much work as people think to meet the new criteria, but it would help to have examples of how some institutions have integrated outcomes, quality improvement, and CME. And it helps to do a reality check, rather than throw up your hands at first glance. “The new criteria specify that your mission and activities address competence, performance, or patient outcomes. It doesn't say you have to do all three for every activity you do. And it doesn't say you have to have peer-reviewed, publishable, fancy outcomes. When you first look at those criteria, that's where your brain goes, that it has to be scholarly work. But they don't say that anywhere. She adds that many providers may already be in compliance because criterion 4 allows for a physician to attend CME to reaffirm his or her current practice, and most CME addresses competence (medical knowledge) and performance already. “The updated criteria do not say providers need a certain percentage of CME to change patient outcomes. The language in criteria 1 through 3 reads ‘competence, performance, or patient outcomes.’ I like that word or.”

It also would help providers to get a little support from outside the immediate CME community, says Balmer. “We need organizations like the Joint Commission on Accreditation of Healthcare Organizations and the Agency for Healthcare Research and Quality to say [to institutions], ‘You know, you really need to get your CME office involved, because they bring a piece to this you don't have anywhere else.’ That [kind of support] empowers the CME provider to talk with [the quality improvement and quality assurance] departments. It's unrealistic to expect every CME provider to have those conversations within their organizations without some assistance.”

Out of the Loop?

While it undoubtedly will be more difficult for those outside a health system's QI loop to achieve accreditation with commendation under the new criteria, it's far from impossible. Medical education companies don't have ready access to quality improvement initiatives or patient data, for example, but they do have strengths in other areas — e.g., business development, project management, graphic design, and medical writing and editing — that they can bring to a smaller hospital or academic medical center that may lack in those areas, says Karen Overstreet, EdD, president, Indicia Medical Education in North Wales, Pa. “Each type of provider and each individual provider within those categories have their own skill sets and competencies. It's a great opportunity to partner,” she says.

“I think [the new criteria] might increase the level of collaboration between provider types,” adds Boyce. “This will result in more thorough, more effective CME programs and CME activities. I hope it will also serve to lessen some of the misconceptions that groups may have about each other.”

Marcia J. Jackson, PhD, senior advisor of education, American College of Cardiology, Bethesda, Md., says that while it will be a little tougher for medical societies than for providers whose parent organizations already have QI initiatives in place, there still are ways to achieve Level 3 accreditation. For example, a society can provide support to its members as they go through self-assessment and performance improvement activities in their own clinical settings. Many physicians now are required to do this as part of their maintenance of certification, so it would be to their benefit to work with a society to provide outcomes data they then can use for their MOC. “That's one way every CME provider can be of service to the physicians. You're not going to get outcomes data unless there's something in it for the physician,” she says.

Some societies may already be fulfilling criterion 16, which says that providers need to integrate CME into performance improvement. (Providers must meet this criterion to achieve Level 3 accreditation.) The American College of Cardiology, for example, already includes performance measures in its education about clinical practice guidelines. “The thought that we would begin to use guidelines and performance measures as part of our educational activities, then measure changes, are all consistent with directions we've been moving toward,” Jackson says. Criterion 17, which requires that providers use noneducational strategies to enhance change, is something the College also is already doing with programs like its Guidelines Applied in Practice, which includes items like chart stickers and checklists.

Others, like the executive director of a small state specialty society, who also prefers to remain anonymous, aren't as hopeful they can keep up. “I am appalled at the new ACCME criteria,” he says. “Where's the money supposed to come from to pay the professional for time to fill out all these forms and [implement these] procedures? Keep in mind that in smaller organizations like mine, we're all volunteers; you can't just keep putting more and more tasks on people.” And, he adds, “We're really being hit with the outcomes piece. It's one thing in a hospital where you can look through the records and find out what the outcomes were. We're an association. I'm not going to survey [participants] six months later to see what they retained, because I won't get the surveys back. I barely get the evaluations back from a symposium.” He's considering getting out of the CME game altogether. “We got accreditation to apply for grant money, and that's becoming more of a hassle. I'm going more the exhibitor route anyway [to bring in revenue], because I can get the marketing money fairly easily, and I don't have to jump through all the CME hoops.”

For smaller providers who feel overburdened and alone when faced with the new criteria, Balmer says she hopes larger providers will step in and provide some relief. “Some of those smaller providers get to a sector of the physician audience that large providers may not serve,” she says. “Rural areas, small hospitals, and small regional specialty societies that are the only lifeline of education to their learners' world are important. It really requires all of us to rethink our connections, because people in those smaller environments don't have the time or resources to build collaboratives; they're all about keeping their heads above water.”

The Good News

While the details are still to come — and most agree that the devil will lie therein — many providers appear to relish the challenges the new criteria bring. “It's a very exciting time to be in CME — and not exciting in the way that all the recent rules and regulations and U.S. attorneys have made it exciting recently,” says Mark Schaffer, EdM, vice president, CME Compliance, Thomson Healthcare, Secaucus, N.J. “ACCME is saying, ‘OK providers. You have a responsibility now not only to help docs understand and correct their own issues, but also to work within the system to correct larger problems providers haven't worked on before.’ I've been talking about outcomes measures for a long time. Now people are starting to get it, because it's going to be important to many aspects of accreditation, as well as being the right thing to do.”

Accreditation under the current system “just means that you're really good at doing the paperwork,” Schaffer adds. “I have surveyed groups that probably deserved exemplary accreditation but didn't get it because they couldn't demonstrate what they were doing. There are probably others who got exemplary accreditation because they were really good on paper, and maybe they weren't so good in reality.” The new criteria, by emphasizing outcomes measures and performance improvement, would make Level 3 accreditation with commendation more meaningful. As a surveyor, Schaffer also is glad to see the phrase “innovative and creative” deleted from the verbiage for achieving exemplary accreditation under Essential Element 3.2. “It was too subjective. And it started to lose its meaning, because what was deemed innovative and creative during one cycle didn't get the same evaluation in the next cycle. People were getting concerned, if not downright annoyed, when they did all the things the other guy did before, and didn't get exemplary accreditation, too.”

Balmer adds, “Theoretically, it's absolutely the right way to go. CME has to get itself placed in the healthcare system in a way that is demonstrable and measurable. We have to go there, whether we want to or not. A lot of us have been moving in this direction for a long time, and this just pushes us to put a time frame on our efforts.” Jackson says that it also puts CME more in line with where physician learners are already going: performance improvement.

Even the new criteria's harshest critics agree with the their philosophical underpinnings. For example, Roseman said in an e-mail on an Alliance for CME listserv that while the criteria themselves add “redundancy, repetition, and seeming obfuscation to the current Essentials,” they are “splendid in intent.” In a follow-up conversation, he adds, “The goal is good. It's apple pie and ice cream and warm bread. The problem is that the document provides very little insight into what the precise, actual requirements will be.”

“It's not so much that the challenges are new, but that the bar has been raised,” says Michael Lemon, president, Postgraduate Institute for Medicine, Englewood, Colo. “Every provider will have to devote serious time and effort to refining needs assessments, activity design and development, and outcomes measurements in order to maintain their accreditation status. The next two to four years should prove to be times of great creativity and opportunity for the CME enterprise.”

As turned out to be the case with the updated Standards for Commercial Support, the most trying time may be this period of uncertainty as providers determine exactly what the new criteria mean and form strategies for meeting them. Once that's done, the implementation may not be as painful as some are braced for, says Jackson. “Change is easy,” she says. “It's the transition that's hard.”

12 Predictions and Portents

The Accreditation Council for CME intends to release more information about how to implement the new accreditation criteria as soon as possible, according to Murray Kopelow, MD, ACCME's chief executive. In the meantime, providers are looking into their crystal balls to see where this new direction might lead. Here are some thought-provoking ideas from those interviewed for this article on the potential ramifications of the new criteria:

  1. In offices where some areas could qualify for Level 3, while others may qualify only for Level 2, the CME office may split into two and seek separate accreditations.

  2. Unaccredited medical education and communication companies may pursue more joint-sponsored activities, and accredited MECCs may co-sponsor more activities with hospitals and academic medical centers. Some may drop out of CME and focus on promotion.

  3. Medical schools will have to decide whether they want to provide CME for external doctors, or stick with providing education exclusively for those within their system to have a better shot at achieving Level 3 accreditation.

  4. Quality improvement department leadership will have to get involved to goad their staff to include CME providers in the QI process.

  5. Providers likely will offer fewer activities, and the ones they offer will be more focused, relevant, and strategic.

  6. The number of objectives for a CME program will shrink to just a few, and those few will have to be measurable.

  7. The target audience will narrow, perhaps even down to an individual physician, as the topic narrows. Your manager may not like it that you're bringing in fewer attendees, but if you get good outcomes, it's hard to argue with that.

  8. Series like grand rounds may not be offered for credit because the outcomes would be difficult or impossible to measure.

  9. Providers will have to collaborate to gather data from learners, because doctors won't participate in outcomes measures unless they have to.

  10. The content validation process will expand beyond just ensuring that the content is valid on its face. “The content can be equally valid if your activity is for primary care physicians or the American College of Cardiology,” says Jann Balmer, PhD, director of CME with the University of Virginia School of Medicine, Charlottesville. “But the context [physicians] work in makes a difference as to whether or not they can use it.” And the new criteria are forcing you to take the work environment into consideration.

  11. Given the accelerating rate of change in the healthcare system, expect the ACCME to change its criteria again in the near future.

  12. If you're not flexible and willing to collaborate, it's time to take yoga and ballroom dancing classes if you want to stay in CME.

Share Your Strategies

Medical Meetings will continue its coverage of the new accreditation criteria in upcoming issues. To share your questions, opinions, and strategies for implementing the new system, please contact Editor Tamar Hosansky at (978) 466-6358; or send an e-mail to thosansky@meetingsnet.com.

New Criteria and Commercial Support

“It'll be interesting to see how pharma will react [to the new accreditation criteria],” says Mark Schaffer, EdM, vice president, CME Compliance, Thomson Healthcare, Secaucus, N.J. “Will they be ultra-safe and provide grants only to Level 3 providers?” wonders Carlsbad, Calif. — based CME consultant Debra Gist. Given current trends, it may well end up that the majority of the grants do go to those with higher levels of accreditation, some say. “Commercial supporters are already looking to see who's doing outcomes and the types of outcomes they're doing,” says Jann Balmer, PhD, director of CME with the University of Virginia School of Medicine, Charlottesville.

“It would bother me if [commercial supporters] got stuck on supporting only Level 3 providers,” says Schaffer. “There could be a lot of providers who for reasons not of their own doing can't get to Level 3 on their own. Accreditation status should be for providers; commercial supporters should be asking other questions, like what kind of outcomes measures they are capable of doing.” But pharma companies may focus on Level 3 providers. Maureen Doyle-Scharff, director, health education, Ross Products Division, Abbott Laboratories, Columbus, Ohio, says, “My goal representing my company would be for us to get to a place where we spend the bulk of our time and support with Level 3 providers. What that says to me is that these are the ones who have figured out — through partnership and collaboration, and leveraging tools and resources — how to make a difference in medical education. That's just a smart business decision on my part. Why spend money on medical education that doesn't do what it is intended to do?”

And funding mostly Level 3 providers will have benefits from the compliance perspective, she says. “My guess is that regulatory bodies would have a hard time poking holes in the industry support of a provider with proven integrity and ability to produce education that makes a difference.”

Will it cause commercial support levels in general to rise or fall? Michael Lemon, president, Postgraduate Institute for Medicine, Englewood, Colo., thinks the new criteria could have a positive cash-flow effect: “If properly implemented, I believe that the updated criteria will result in CME providers elevating their CME programming to address actual practice-related problems of physicians that should ultimately result in increased funding.”

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