An Already Highly competitive funding environment is becoming even tougher for CME providers. Facing decreasing budgets and increasing regulatory scrutiny, commercial supporters are becoming much more discriminating about approving grants.

“Five years ago we approved 70 percent of the grant applications we received; that figure dropped to 26 percent in 2008,” said Christine Beebe, MS, associate director, medical affairs, Takeda Pharmaceuticals, Deerfield, Ill. Speaking during a standing-room-only session, Elements of a Quality Grant Application: An Industry Perspective, at the Alliance for Continuing Medical Education annual conference, held January 28-31 in San Francisco, Beebe and two other panelists offered providers their insights. (They clarified that their views were their own and didn't necessarily represent the opinions of their companies.) With her team reviewing 3,000 grants annually, some of them 100 pages long, yours must stand out in order to gain approval, said Beebe. Providers need to demonstrate that the education they are proposing will result in improved patient care, the speakers said. “I can't say enough about how important it is that providers include a mechanism for appropriately measuring and publishing the outcomes of education activities so that we can demonstrate their value internally to our administration,” Beebe said.

Get Specific

To make your grant request stand out, you need to include very specific needs assessments, panelists said. “We are not interested in humongous literature reviews,” said Beebe. “We know there is a diabetes epidemic. You need to home in on practice gaps.” To illustrate that point, panelists asked attendees to weigh the relative merits of two grant applications.

The needs assessment in Grant A included a four-page narrative describing the prevalence of hypertension in the United States, with current references, documentation showing that hypertension continues to go underdiagnosed and undertreated, and the results of a national survey illustrating some of the reasons physicians may undertreat hypertension. Grant B included all of the above, but it then zeroed in on a rural practice network of four clinics in Alabama where a sampling of patient charts showed that while healthcare practitioners are checking 80 percent of patients' blood pressure, they are giving only 20 percent of patients the treatment recommended by guidelines.

Grant A proposed live and Web-based presentations, reaching physicians across the entire United States. In contrast, Grant B proposed local education, including six “lunch and learns” for the entire clinic staff in Alabama, ongoing patient chart audits, and patient-education posters. The provider also planned to publish a paper about the project.

Asked to comment on which proposal was more fundable, participants said Grant B won easily. One attendee noted that Grant B was more effective because the provider collected data about a practice gap from a specific community and proposed education that would target those local needs.

Another attendee pointed out that Grant B included education for patients and all of the staff, as well as physicians — another plus from a commercial supporter standpoint.

“As we move to performance-improvement CME, it's important to remember that physicians are only one part of the healthcare team,” said Jacqueline Mayhew, director, medical education group, Pfizer, New York.

Attendees also thought Grant B had the potential to achieve Level 5 outcomes (changes in patient health), while they thought Grant A might achieve Level 4 outcomes (changes in physician performance).

The panelists considered Grant B much more likely to receive funding, even though it aimed to reach fewer people at a higher cost. The expected cost per learner for Grant A was $80 ($400,000 divided among 5,000 learners); in contrast, the cost per learner for Grant B was $1,500, or $60,000 divided by 40 learners. One attendee observed that even though Grant B's cost per learner was much higher, the impact could be much greater. Mayhew agreed, saying that the publication of the results in Grant B meant that the project could be replicated, adding to its value. Cost is less of an issue for us than the quality of the grant, she said.

Match the Objectives

Another grant-writing essential: Make sure the learning objectives are focused on the practice gap, said Beebe. “Sometimes I see a fabulous needs assessment, but the learning objectives don't match up. It sounds intuitive, but it's one of the main reasons we reject grants.” For example, if a needs assessment shows that primary care physicians do not use the “gold standard” of joint aspiration in diagnosing gout, an appropriate learning objective would be that participants be able to identify when to use joint aspiration for diagnosis. Learning objectives that don't fit this particular need might be: Participants will be able to discuss the pathophysiology and etiology of gout, and participants will recognize how to effectively use gout therapies.

From Paper to Practice

While many providers realize activities should employ adult-learning principles and incorporate formats that will be most effective in achieving the learning objectives, they need to ensure that these methods work in practice, not just on paper.

For instance, show that you will use an audience-response system appropriately, said Beebe. “We see ARS used to ask questions about the weather,” she said. Case studies must be incorporated into the presentation, she said, explaining that her team has observed activities where a case study was up on one screen, while the lecturer went over slides on another screen, making the cases gratuitous. Or presenters left no time at the end of the presentations to review the cases.

Budget Basics

Providers also need to demonstrate fiscal responsibility, said Beebe. Takeda received $1 million back from providers for grants allocated in 2008, Beebe said. While there are many reasons for the refunds, the company is re-examining the process to make sure they are not overcharged in the future. Budgets should not include large lump sums for overhead, said Beebe. Rather, grantors need to see individual line items, showing, for example, how much an administrator will be paid per hour for how many hours. Providers also need to prepare reconciliation reports documenting how the activity money was spent.

What's in a Faculty Name?

In addition to focusing on educational and fiscal aspects, you must also consider legal and compliance ramifications, explained Kristin Rand, JD, group manager, Genentech, South San Francisco. Grants must not suggest in any way that commercial supporters have input or influence over content or faculty. “Every word tells a story,” Rand said, “so your language choices are important.” For example, if a grant says “recommended” or “suggested” faculty versus “potential” faculty, it can imply that the provider is asking the supporter whether or not they accept the faculty choices. “It's subtle,” Rand said, but such wording can be a reason for some companies to decline a grant request.

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Since each company has different policies regarding whether or not they can approve or even review grant requests that include faculty names, Rand said, it's important to find out the policy of the commercial supporter you are approaching or you may get a decline letter and not know why. Takeda does approve appropriate and compliant grants that include faculty names, Beebe said. However, Mayhew recommended not including faculty names in proposals for Pfizer. Under the terms of a court settlement, Pfizer cannot fund grants if speakers named in the proposal have been promotional speakers for their companies during the 12 months prior to the grant request. (Merck is under similar restrictions.) Commercial supporters' policies regarding this and other issues should be posted on their Web sites, but to get answers to your specific questions, you may need to call, panelists said.

While providers know that supporters will reject grant requests that focus on brand names, some grantors will also look at the number of times treatments are mentioned by their scientific names, said Rand, as part of their evaluation of the proposed activity's overall balance. “Some requestors think that by mentioning a company's products multiple times, the chances of approval may increase,” Rand said. But those mentions may have the opposite effect, she said.

When describing outcomes measurements, it's particularly problematic to mention changes in prescribing behavior, Rand said, as the goal of activities should be to close identified educational gaps that may or not have anything to do with prescribing behavior.

Another potential trouble spot is including a section of an outcomes study from a prior activity if the example you choose has to do with a specific treatment, as it could look biased to review committees at some companies, Rand said. n

Sidebar #1: Code Blue for Resort Meetings?

The revised PhRMA Code on Interactions with Healthcare Professionals, which went into effect in January, states that resorts are inappropriate venues for meetings sponsored by pharma companies, such as consultant meetings. But what about CME events? Polled via an audience-response system, attendees at a grant-writing session at the Alliance for CME annual conference about were asked whether it was acceptable to hold conferences in ski resorts. The largest number of respondents — 53 percent — said no, because of the perception issue. Twenty-five percent said ski resorts are acceptable sites as long as the education, rather than skiing, is the focus of the conference; while 22 percent of respondents were on the fence.

However, the speakers from pharmaceutical companies were much more definite. “Nine times out of 10, if we see a ski resort on the grant application, we will decline the application because of that,” said Jacqueline Mayhew, director, medical education group, Pfizer, N.Y. Her fellow panelists, Christine Beebe, MS, associate director, medical affairs, Takeda Pharmaceuticals, Deerfield, Ill.; and Kristin Rand, JD, group manager, Genentech, South San Francisco, agreed.

A frustrated audience member from a medical specialty society pointed out that the PhRMA code specifically states that accredited providers should control all aspects of CME, including venue selection. “How can you say you comply with the PhRMA code and then decline grants for meetings held at resorts?” she asked.

”Yes, it is up to you to choose the venue, and you can choose resorts, but commercial supporters may not be able to support the grant due to internal corporate policies,” responded Rand.

Sidebar #2: The Panelists

Jacqueline Mayhew, director, medical education group, Pfizer, New York

Christine Beebe, MS, associate director, medical affairs, Takeda Pharmaceuticals, Deerfield, Ill.

Kristin Rand, JD, group manager, Genentech, South San Francisco