The world of commercial support is changing, and CME providers find themselves frustrated and confused by all the new forms, online grant-request processes, and the dearth of people to turn to for help. That's why they swarmed to a session presented by a group of pharmaceutical executives entitled, “Navigating the CME Landscape to Improve Patient Care: Pleasures, Pain, Perils, and Pitfalls of Commercial Support.” The session was part of the Alliance for CME annual conference, held in January in San Francisco.
The pharma panelists, who did not want to be quoted by name, first explained just how the landscape has changed: While the number of activities — and grant proposals — are still on the rise, resources on the pharma side are not keeping pace. And while providers need to satisfy the Accreditation Council for CME's requirements, pharma companies also have to comply with the Office of Inspector General and Food and Drug Administration guidelines — something that providers tend to forget. As one panelist said, “One of the big barriers to collaboration is the provider's lack of knowledge about commercial support. Some providers say, ‘We don't care about the FDA.’ Well, we do.” They also explained that those regulatory agencies were behind much of the pharmaceutical industry's move to separate education from.
What can CME providers do to give their proposals the best chance for approval in this tightened environment? Here's what the panelists suggested.
Getting in the Door
It used to be that CME providers could work with pharma sales reps to explain their proposals. Now most companies have centralized the incoming grant review process under a Medical Affairs or similar-sounding department, or have put their proposal-processing systems online. As a result, the number of staff people handling grants has shrunk from hundreds or thousands to just a handful, in many cases. While this is safer from a regulatory standpoint, it makes life more difficult for providers who have relied on relationships with sales reps or others in the marketing department to get their foot in the door, grant-wise.
When the audience asked how to find the right person to speak with about their grant, panelists suggested looking at the Alliance for CME directory for likely prospects at various pharma companies. “Even if [the Alliance member is] not the right person, [he or she will] help you find the right person,” said one. But keep in mind that most companies get tens of thousands of grant requests, have only a comparatively small bucket of money, and lack the infrastructure to deal with all the providers who want to plead their case. In response to a question about why they didn't just list their CME people on their Web sites, one panelist said candidly, “We did that on purpose. We wouldn't be able to handle all the requests.” Some companies have medical liaisons to handle smaller requests. If you simply must talk with someone about CME, ask the switchboard to connect you with medical information or public affairs, they suggested.
Grand rounds requests seemed to be particularly bothersome. The sales reps used to be able to break down aneeds assessment into individual clinical categories, but with reps out of the loop in most cases now, CME providers are on their own, panelists said. You need to provide individual needs assessments for each therapeutic area that is covered in your grand round activities.
While some companies still allow CME providers to deal with the marketing department, that wasn't the case for these panelists. “We're really strict. If something comes to us from marketing, even if they didn't open it, it won't be approved,” said one. Others added that marketing people have been fired for getting involved on any level in the grant process. The panelists said providers should ask their marketing contacts whom to call. If they say they don't know, “That's tantamount to saying there's no interest in your idea. They know.”
Conflicts and Firewalls
Not surprisingly, conflicts of interest — and the avoidance thereof — were an issue for the pharma panelists and the CME providers in the audience. After all, it's in part the appearance of the potential for impropriety that caused pharma to make all the changes it has recently, including cutting sales reps and marketing departments out of the commercial support loop, centralizing their grant-proposal processes and, in many cases, putting the process online. Further complicating the issue on the activity level is that some states now require pharmaceutical companies to adhere to certain dollar limits when it comes to payments to. Some companies are also requiring documentation on how the CME provider is ensuring that there are no conflicts of interest among their committee members and faculty.
Med ed companies that include a promotional arm were particularly anxious about the criteria they must meet to get a share of the commercial support pie. The panelists said that it helped to have a serious focus on independence: “We like to see a monitoring process, good compliance with, excellence in the therapeutic area, and the ability to generate outcomes data,” said one. “If there's marketing anywhere in the education, you will not get a grant from us,” said another.
Pharma companies want to know that there are firewalls between a MECC's promotional and educational arms, but added that they aren't willing to police firewalls. (See box on page 28 for some suggested firewall components.)
Forget Passive Programs
Noting the sheer volume of proposals the pharma folks were getting, one audience member asked, “What one thing could we put in our proposals that would make your life easier?” One panelist said, “Follow the directions exactly.” Another replied that he'd want to see a “fantastic needs assessment and a dynamic program, not the same old [format].”
Another noted: “Passive learning is the least-effective way to take away new knowledge. So why are passive learning activities the vast majority of the grant proposals we get?” The takeaway was to be sure to include any use of audience-response systems, Q&As, and case studies for lecture-based activities, and include any preliminary and post-activity follow-up that shows it's more a process of serial learning than just a lecture. The needs assessment should effectively identify why the activity is needed.
Outcomes measurement also will help get your activity over the grant-process hurdle, but only if it's done right. “In the past, some companies might have accepted evaluations based on prescriptions. No more. We need to know how you spent the money and what the patient outcomes were,” said a panelist. While prescription-tracking is generally verboten, it still can be a “reasonable measure” if it can be done across the therapeutic class, said another panelist, with the caveat that there would have to be more than one drug in that class.
Another complained that even the basic measure of attendance isn't being met in all too many cases, and that the results they do get tend to be “sloppy.” One panelist, whose company tries to fund two to three outcomes measurements per year, looks for a minimum of pre- and post-activity surveying. Another said, “I want proof, not just a survey. We have to defend the money we spend.” Another replied, “What you're hearing now that you wouldn't have heard five years ago is that we want to see outcomes measures and we're willing to pay for it.”
Sorry, Wrong Topic
But if your activity is outside of that company's clinical categories, it isn't going to fly, regardless of how great the needs assessment, programming, and outcomes measurement is. One audience member asked about funding for a program about off-label uses for depression medications in adolescents, and all the panelists could say was, “Sorry.” One added, “There is a tremendous need for education in some topics, but [pharma companies] can't support them.” While disheartening to the CME provider, it was not an unexpected response, given the recent media roasting some companies have had over the increased use of depression medications for adolescents and off-label promotion
One question that didn't get answered after all this discussion, though, was an essential one: “How do you convey what you're doing when all they want [on the grant proposal] is therapeutic category and title?”
If MECCs with both educational and promotional arms want to obtain funding, they need to include the following components in their firewalls, said the pharma panelists at the Alliance for CME annual conference session about industry's new grant policies.
Separate content development — a writer can't work on promotion and CME, for example.
Have a compliance officer, separate tax ID numbers and P&Ls (profit and loss statements), and a policy on repercussions for noncompliance.
Make sure no personnel on either side overlap.
Have separate servers for the computer systems.
Dealing with Rejection
Audience members at the Alliance for CME annual conference session about commercial support wanted to know how to deal with resubmitting rejected grant proposals.
The panelists reminded them that one clinical category may get 2,000 proposals, and have the resources to accept only 70 — rejection is very common. One panelist had a different take: “There's a reason why a proposal get rejected, so think about why it got rejected before you resubmit.”
Another pointed out that you have to consider where that category is in terms of the life cycle of the company's drugs — you might be looking at an area that no longer has funding. In that case, resubmittal would be a waste of everyone's time.