I love this idea from Tom Peters:

STOP … using the term “healthcare.”

START … using the term “health.”



Better HEALTH is the goal–and if we did “it” (focus on “health”), then “healthcare” would be far, far, far less necessary. (Understatement.)

…get a life. Here I am in beautiful San Francisco on a Saturday night, and I’m sitting in a hotel room typing up notes. Is that pathetic or what?? I have one more session to write up, but I think I’m going to call it quits for the night—my brain hurts.

This is such an important topic for CME providers that I hope the Alliance gives it a marathon of its own next year. Now that New Jersey and California have rules mandating some form of cultural competency training for healthcare workers in place, and several other states are considering it, this topic will only get hotter as time goes on and the U.S. population continues to diversify—and as disparities in healthcare among different ethnicities continue to plague our people. OK, off my soapbox.

I’ll wait until I get the slides before doing a full writeup on this one. Medical Meetings also covered some of the same ground in an article I can’t find right now online (I’ll add the link when I can find it. Update: here it is). Plus writing up the marathon commercial support session has me whipped for the night. But presenter Alejandro Aparicio, MD, with the AMA, made a compelling case for the pervasiveness of healthcare disparities that exist in the U.S., even after adjusting for income and insurance. The Institute of Medicine 2001 and 2002 reports said that medicine should be equitable, and that healthcare providers can benefit from cross-cultural education. Robert Like, MD, with the UMDNJ Center for Healthy Families and Cultural Diversity, outlined the efforts in this area currently going on in the undergraduate and graduate arenas, the Calif. and N.J. rules, and efforts going on globally from New Zealand and Australia to Europe.

Like talked about the business case for cultural competency training for healthcare workers (employers have to cope with absenteeism and unhealthy workers as a result of the disparity in care), the research case, and of course the financial case.

“Keep in mind that there can be huge disparities and differences within one group,” he added. For example, be careful when using the terms “Hispanic” or “Latino” when addressing that ethnicity: “There are political things attached to each term, and you could get a volcanic reaction if you use the one that isn’t how people identify themselves.”

Some rules to live by:

* There is no “cookbook approach” to treating patients.

* Avoid stereotyping and overgeneralization.

* Think of ethnicities in terms of strengths and assets

* Keep in mind that every encounter is a cross-cultural encounter.

Admittedly, this self-selected group already had an interest in the topic, but I still was surprised when, using an audience response system, we found out that 64 percent of the audience had already provided CME activities dealing with healthcare disparities or cultural competency. Some examples the audience provided of programs they’d done:

* To resolve problems physicians were having dealing with death and dying among patients of different ethnicities, the provider brought in religious leaders within the various cultures to help docs understand how to handle their specific needs.

* Another provider said his university was in the fourth year of providing conferences on disparities in specific disease states.

* Another is planning a three-day program on disparities in healthcare.

Eighty percent of the audience also said they were planning to provide cultural competency activities in the future. But there are hurdles to overcome. For example, one audience member is struggling with terminology: to her, the “underserved” in the annual CME innovations in best practices for the underserved her organization puts on means “minorities,” since she’s in an urban environment. For others in her organization in more rural areas, “underserved” means something else. There’s also pushback from docs, as one California-based provider said. “Physicians in California are angry because they’re being legislated to have to do cultural competency CME, on top of the other mandated topics. It’s just another micromanaged part of their education.” But, as Like pointed out, cultural competency isn’t just another topic for CME—it’s part of everything you do (remember, every encounter is a cross-cultural one. Think about it.).

Cultural competency training really has to take a systems approach, he added. “It’s not just the culture of the patients, but also the doctor’s cultural background, the culture of the organization, and the culture of healthcare.

Update/Note: When I interviewed Dr. Like for this article on cultural competency and CME last year, he sent me a terrific list of resources to go to for more information. It fell off our home page when we redesigned Medical Meetings last fall; I’ll add it back, now that I notice it had disappeared. To download the Word file, click here.

That’s right, this morning was a three-hour, 45-minute, no-break marathon on everything you wanted to know about commercial support, but never had the opportunity to ask. Led by moderator Lawrence Sherman, who I just learned today has left Jobson to be the CEO of The Physicians Academy for Clinical and Management Excellence in New York, the session consisted partly of presentations from a panel of pharma folks (and one ex-pharma person), and partly of lots and lots of Q&A from the audience. I don’t know if I have the stamina left to post everything they talked about (look for more in the next issue of Medical Meetings), but here are some of the highlights.

But first, my favorite quote from the session. An audience member who had attended this session for the past couple of years said at the outset, “I’ve found the Pain, Perils, and Pitfalls sessions gave me more pain than pleasure. Can we have a better balance this year?” Alas, since the situation remains painful, that person probably left looking for an aspirin once again.

Supporting off-label CME: When asked by the audience what the situation looks like nowadays for getting support for off-label CME, one panelist said, “Our policy follows the Neurontin case. If we don’t have a trial in place or an indication moving forward, we won’t support it.” Another said, “The label is irrelevant to CME as long as what you’ve done represents the true and complete story.” The echo from another panelist: “If the grant request is based on appropriate science, the label doesn’t matter to me.” One panelist said that most CME contains some discussion of off-label use. “We just have to make sure we’re not just talking about off-label use.” Another added, “We would not support an activity that just talks about off-label use and nothing else. While the OIG isn’t focusing on CME, they will get to it.” But if the off-label use is the standard of practice and you don’t teach it, that wouldn’t be right. “The point is that you can do it—we can’t. Prove independence and verify that there’s no conflict of interest, and you’re done,” said a panelist. Sherman added, “Keep in mind the confluence of the needs of the learners, commercial supporters, and providers when justifying the use of off-label discussion. You have to figure out where the point is where all these needs meet.”

Supporting non-specific-disease-state CME

Another burning question from the audience was about the chances of getting commercial support for CME that doesn’t focus on a specific disease state. One panelist said his company does a few of these a year, but most of what they support is disease-state-specific.

Meeting outside the U.S.

One audience member who works for a U.S.-based organization that will be holding a meeting in Canada. Whose rules rule? The panelists agreed that it should be U.S. rules. One whose company’s headquarters is based outside the U.S. said enterprising MECCs where getting to know marketing managers in other countries in the effort to gain a foothold with them. “We trained the other offices to kick anything that mentions ACCME back to the U.S.” to stop that from happening, he said. Another panelist said that any grants they provide must take place on U.S. soil. “The others are a pain in the gluteus maximus. We end up having to ship the proposal off to attorneys in that country. There’s also tax involvement—it’s just a nightmare.”

Compliance is job #1

This came through loud and clear from the pharma panelists. One even started her presentation by quoting the Ford motto, adding, “if we don’t make compliance job #1, the funds for CME just may dry up.” She reminded the audience that ACCME rules are just one piece of the puzzle, and not one on the top of pharma’s mind. “We have providers sign an agreement to follow all the rules, including corporate and state rules. We can work together as long as we make sure it’s done ethically.” She added that the Office of the Inspector general views pharma as “guilty until proven innocent,” adding that “the inability to prove compliance can be as costly as noncompliance.”

Compliance also means ensuring that there are no conflicts of interest of any kind, including being able to verify and document all due diligence. The OIG is looking for policies and procedures, monitoring and auditing, ensuring that there’s a compliance officer, and training and education in following the rules. This means pharma may very well be double-checking providers on things like ensuring the line budget items are fair market value, and that any foundation listed as a partner really is a 5013C by checking with GuideStar. For medical education companies, pharma wants to know the firewall is heat resistant, this panelist said. “This is critical. We’re not allowing vendors to cross the line at all. If you have our promotional business, you won’t get our CME business.”

A smaller pharma company person from the audience asked if her company had to do everything that big pharma does. The panelists were a little mixed on the answer. One said that OIG won’t expect them to do everything the big companies do, but to document your processes and the intent of your compliance program. Another said, “I disagree. If you don’t have enough people to do all the screening and monitoring, you need to go to management and plead your case. OIG doesn’t care if you’re big pharma, small pharma, or a MECC. If you don’t audit, monitor, and correct, all you have are words on a paper.” Another added, “You need to have and follow defined processes. FDA and OIG are tracking all the dollars.”

Support for disease-state topics that may not cover a specific product category within that disease state

An audience member spoke of a dilemma: “We recently had a grant turned down under general GI disease because it didn’t meeting their guidelines for a sub-topic under GI: GERD. One panelist said that if it doesn’t cover that company’s interests, don’t submit it. “Keep in mind that we’re restricted,” another panelist said. “I know you can’t tie it to a specific product, but it would be a good idea to be more targeted. It’s a fine line.” To which a provider replied, “You can’t get too specific, but if you’re too general, you won’t get the grant. We’re in a Catch-22.”

Panelists suggested looking at the Web sites to find topics they would be willing to support within that disease state. “We offer some of the top-level learning objectives we’re interested in to help guide requestors, and our lawyers are comfortable with that.” Another suggested scoping out the company’s Web site to see what they’re doing in that topic area. “If there’s a match, submit it. But don’t make up a match if one doesn’t exist already from your needs assessment.”

What pharma wants

One panelist outlined what his company was looking for in some areas. For a grant request, that means: a signed grant request letter on official provider letterhead; budget with line items; thorough, referenced, and valid needs assessment; outcomes assessment tools; general topic (not the content); tactical p lan of the activity; type of audience; number of credits; type of program(s) to be supported (monograph, seminar); name of any company that will be assisting with the activity so the company can ensure that it doesn’t have a separate relationship that could prove problematic.

Can we meet face to face?

Providers really want the chance to plead their case to a live human, and not rely on an impersonal Web site that doesn’t let them explain the nuances. Not going to happen, said the panelists. “Submit a request and if we’re interested, we’ll get in touch with you” to find out more about who you are and what your activity is all about.

How do pharma companies decide how much to spend on what? Does marketing have a say?

The question: “When you do your budget, do you h ave a strategy for the types of grants you want t o fund and wait for them to come in, or do you just evaluate the ones that come in based on your disease states of interest?” The answer: “Yes.” Another panelist said his company does its own needs assessment to determine the relevant audience and what type of education is most likely to affect that audience. “We do this with compliance, medical affairs, finance, and sales and marketing.” But should sales and marketing be involved in this type of decision? “The OIG says sales and marketing shouldn’t be involved in granting functions, but our money comes from the sale of our products, bottom line. During our budget planning season, we ask them for general directions, but not specific guidance. After all, the money comes from them.”

Another pointed out that every company is set up differently, and some medical affairs departments actually compete with sales for the dollars. Others get the money straight from corporate. “Sales might see our budgets and line items, but not our grant requests. After a grant is approved, we can share.”

Providers also wanted to know if there are limits on the number of grants, or on the dollar amount, they give to a particular provider over the course of the year. “We do limit dollar amounts for each disease state, and spread them around geographically. But this really refers mainly to grand rounds,” said one panelist. Another said his company limited the dollar amount given to a specific provider to “the amount the lawyers have determined would amount to us have bought the organization.” Another added that the senator investigation by Grassley et al is looking closely at this area.

Do pharma companies have a list of preferred providers that they use? If so, would they be willing to share it with third parties who also want to work with providers supporters like to work with?

Most of the panelists said they didn’t keep a list like this. “We work with the same people more than once, sure, but we don’t keep a list.” Another said, “You as providers need to qualify your own MECCs, do your own due diligence.” Sherman added that sharing such a list, even if they had one, would entail a huge potential legal liability. A panelist added, “We have to be careful not to be a perceived agent of record.” Another said, “We do have a list of med ed companies that do promotional work for us, and another of those that do med ed. We don’t let anyone do both.”

What about three-way contracts?

Well, it varies from company to company. “We only sign letters of agreement with the provider, and the provider works with their providers. We steer clear of three-way contracts,” one panelist said. Another said, “We want a contract with all the providers.” Yet another said, “We want them all listed in the LOA, but it has to be signed by the provider.” Another added that they insist on including a line in the LOA that the MECC isn’t involved in anything on the promotional side.

If it’s a joint or co-sponsorship, one panelist said he would want signed letters from both partners; another said one letter is OK, but it has to be signed by both.

Any spinoffs from the conference, such as monographs or CDs based on the main event, also should be determined ahead of time, including who is going to produce them.

Why support a didactic dinner lecture that you know isn’t going to change behavior?

One panelist said that, while the lecture might not be the best vehicle for learning, its effectiveness in large part depends on where the product is in its life cycle. “If it’s new, that big association dinner meeting is the perfect place for that product. And if a mature product gets a new indication, it’s like it’s new again.”

“It’s not wrong to support a large, didactic activity,” said another panelist. “We have a brand in a mature market, and there’s no need to do a lecture. But we’re the market leader, so we have to be there. We’ll do it for goodwill and public relations, support whatever the provider thinks would be important for people to learn.”

More on product lifecycles

One panelist pointed out that, as a product matures, the funding shifts from CME to promotion. “Keep the lifecycle of the product in mind when making a grant request.” Another added that patent expirations, which are public records, also can be a way of seeing when a product is nearing maturity.

All about outcomes measurement

Pharma says its interested in supporting outcomes measurement, but it’s not without its challenges. For example, outcomes measurement is still fairly new, and there are no standard was of statistically measuring to get the data as of yet. Also, since the data providers give to supporters may go beyond the medical affairs office, it needs to be in a format that’s easily understandable to people who aren’t well-versed in CME. And the methods need to be spelled out: “Outcomes are expensive, so I need to know what I’m paying for, and why.”

There also are limitations on outcomes measurement when a commercial supporter is involved. For example, the architecture and methodology could pose a problem for funding if it appears to be specific to prescriptions to that company’s drugs. While scrip data of a drug class is not forbidden, one has to be careful not to get too specific. Also, the outcomes being measured should align very closely with the objectives of the activity. The level of outcome being measured also should be aligned with what you could expect from that program. An activity to raise awareness of the guidelines for a particular disease state, for example, shouldn’t measure level five gains in overall public health statistics. “That’d be a reach,” said one panelist.

One area of non-agreement among panelists was if a financial incentive were involved in recruiting a control group (which most said was a must-have for any credible outcome measure). “If they were going to give an Amazon.com certificate to incentivize the control group to participate, we’d have a problem with that,” said one panelist. Another added that they couldn’t support a study that included an exchange of money or gifts, while yet another panelist said “we don’t mind a small payment to those who participate in the control group for outcomes measurement. It’s not our relationship with the physician; it’s the provider’s.” To be safe, another said she’d run it by her lawyer if she saw that as a line item. “I’d find the $100 dinner more problematic that $5 sent with a survey,” a panelist retorted.

As to whether a third party should be funded separately by the supporter to do the outcomes measurement on another provider’s activity, well, some perceived that to be too close for comfort. While an outside pair of eyes can find things the provider may not, there could be all kinds of problems with things like getting a detailed list of participants, understanding the content well enough to measure outcomes, and the potential for it being seen as attaching a string or condition to the grant. A panelist said, “The provider should do the outcomes.” An audience member agreed, saying, “It’s part of the educational process and should be the provider’s job to do.” Another added, “If a third party is going to do it, the provider should hire that third party.” The panelists said that they approve grants with this as a budget line item all the time. And the methodology should be laid out from the start so the provider can’t change it in mid-stream if the results aren’t looking too good.

But what if the outcomes don’t turn out so great? “It has to be what it is, good, bad, or ugly,” replied a panelist.

There also was some discussion of what seems to be a highly theoretical potential problem with outcomes measurement, i.e., what to do if an adverse drug reaction is uncovered during the outcomes measurement. This only would happen with chart audits and, as one panelist said, “If I know enough about an individual patient’s adverse event to report it, I’m getting information I shouldn’t get. We’re getting into HIPPA territory.” This would be much more likely to come up at a promotional event, another added, where someone might stand up and say the drug didn’t work.

This has nothing to do with CME, but I thought it was fascinating: HomeWeb game provides breakthrough in predicting spread of epidemics.

Using a popular internet game that traces the travels of dollar bills, scientists have unveiled statistical laws of human travel in the United States, and developed a mathematical description that can be used to model the spread of infectious disease in this country. This model is considered a breakthrough in the field.



“We were confident that we could learn a lot from the data collected at the www.wheresgeorge.com bill-tracking website, but the results turned out far beyond our expectations,” said Lars Hufnagel, a post-doctoral fellow at the Kavli Institute for Theoretical Physics at the University of California, Santa Barbara and co-author of an article describing the research in the January 26 issue of the journal Nature.

Bird flu was in the news again last night, freaking me out once again. So, if this works, that’d be great. In the meantime, are you prepared?

I’ve been told that I can’t write anything about this session without running it past the American Medical Association first, but from what I heard, most of the updates to the system have to do with protecting the AMA’s intellectual property and streamlining the system. Look for some feedback and answers to attendees’ burning question in the March/April issue of Medical Meetings. But most of what they talked about is covered in the new booklet that is now available from the AMA’s Web site at no cost (the direct link to the download is here). They also said, and I think it’s safe to say this much, that they’d be glad to answer any questions you might have. Just give them a call.

Phew, I’m done for the night! I’m looking forward to the marathon commercial support section tomorrow morning, especially since it’s being moderated by Jobson Educational Group’s Lawrence Sherman, moderator extraordinaire.

This turned out to be a really interesting session. Brooke Johnson, Duke Office of Continuing Medical Education, walked us through a pilot study she conducted to determine what physicians, residents, and pharmacists know about what’s appropriate in a CME setting. Despite a low response rate and some other design limitations, the results were worth noting.

Most of those surveyed had attended CME activities, 40ish percent (it’s hard to tell exact percentages from the bar charts) had experience as speaker/moderator, and some had served as CME committee members and course directors (almost none currently were current or past CME medical directors). Sixty-ish percent had no commercial relationships, and less than 20 percent were members of speakers bureaus, stockholders, or received clinical research grants.

The survey posed a number of questions and scenarios, most of which came straight from the American Medical Association’s Web site. Johnson also had the audience respond with a yes, no, or not sure to the same questions before telling us what the survey results were for each scenario (yes, I got one wrong). Anyway, the first was: ACCME-accredited providers are responsible for reporting, to each commercial supporter, information concerning the expenditure of funds each has provided (this is the one I got wrong—I had no idea you had to do this. Still sounds wrong to me. But I digress). The answer was “true.” A little more than 40 percent got it right; a little more than 20 percent said “false,” and the rest were unsure. But then again, the audience at the session was really mixed, so we weren’t too different from those surveyed in the study.

The second question they asked was: When a commercial supporter provides an educational grant in support of a certified CME activity, they can receive free exhibit space. Even I know that this is false, that education and exhibits have nothing to do with each (or shouldn’t, anyway), though from what people in the audience were saying, it’s not an uncommon practice to give them a freebie as long as it’s not a part of the deal. Debra Gist, a consultant who formerly was with Duke and who helped Johnson present, said it’s just good practice to avoid any possible appearance of quid pro quo going on.

The third question was a scenario: A referring physician is invited to a 45-minute lecture by a respected clinical researcher. The activity is certified for AMA PRA Category 1 ™ credit by an academic medical center.

An educational grant has been provided by ABC pharmaceutical company, there are no registration fees, and the session will take place in a baseball park just prior to a professional game.

Following the meeting, attendees and their spouses are given free tickets to stay for the baseball game. Could this be considered in violation of the antikickback statute?

Well duh, of course. But only 40ish percent of survey respondents said yes, while 20ish percent each either weren’t sure or said no.

Next scenario: A pharmaceutical company invites physicians to Whitewater Adventure for a weekend of rafting and continuing educations. Physicians will spend Saturday conquering the river, followed by a speaker who will lead a brief medical discussion Saturday evening. Is this offer appropriate?

Duh again, obviously not. Most of those surveyed recognized this as a no no, although 25 or so percent thought it was OK or weren’t sure.

The next one had the really surprising results. Here’s the scenario: A physician attends a CME activity certified for AMA PRA Category 1 credit by an ACCME-accredited provider and financially supported by a pharmaceutical company.

At the end of the activity, the industry rep stands up and thanks everyone for coming on behalf of the company. She also states that anyone who would like additional information about the drug discussed in the CME activity should feel free to contact her. Is the behavior of the rep appropriate for the forum?

Most definitely not. But 60 percent or so of the physicians, pharmacists, and residents thought it was just fine.

And when asked how reliable they thought the information comparing their company’s drug to others on the market a pharma sales rep gives them is, the physicians were most likely to say it was very reliable, followed by the residents. The majority of all three groups, though, put it firmly in the “somewhat reliable” category.

Johnson then asked for ideas for followup research, to which I replied, why not survey the major newspapers’ medical reporters on their knowledge of CME regs? (Yes, I was getting snarky, but wouldn’t that be fun?) Most of the discussion centered around the fine print of some of the scenarios, and pointed out that the AMA questions were written three years ago, and things have changed since then. If you have any good ideas, I’m sure Johnson would love to hear them (you can e-mail her here). She also is looking for feedback on a site Duke put together to help increase awareness of CME regs. It’s at http://cme.mc.duke.edu.

P.S. I asked Johnson to e-mail me her slides, and also the write-in comments people had, and I just have to share this one because I hear some version of it every year on our Annual Physicians Preferences Survey: ” i wholly support drug company funded educational activities. No one else will provide them to us for free, we will not pay to attend them, and we learn a great deal from them. It is idiotic to assume that we are swayed like little children by a drug rep when the next day their competitor will come and refute it with other evidence. we are grown-ups that can decipher the truth in the materials and make clinically appropriate decisions.”

Though my favorite was this one: “FACT: I am for sale and can be bought–especially if a golf trip is involved. I freely and publicly disclose this. Please share this fact with ALL in the industry.” Well, dude, consider it shared.

Here’s another case from the session on preventing the appearance of bias.

Case 3: Faculty selection

Dr. Gray Matter has been asked by the American Society of Cardiac Cures to make a presentation regarding a heart gizmo newly released by Fix-It Device Company. Dr. Matter, an excellent presenter and world-renowned interventional cardiologist, is the primary researcher for this new product and spent ore than a decade developing it. He is a major shareholder in Fix-It, and has noted this on his disclosure form. The education coordinator for the society has noted the disclosure information and intends to discuss this during the upcoming Education Advisory Committee meeting.

Seventy-four percent of the audience voted via ARS that this had a high chance of having the perception of bias; 60 percent said it would be most difficult to comply with Standard 2 (resolution of personal conflicts of interest), 20 percent said it would be tough to comply with Standard 5 (content and format without commercial bias). The vast majority said they would exclude him altogether.

He still could be doable, some said, if he was limited to talking about the development of the product, not patient recommendations. Other possible mitigators people suggested included rigorous peer review, fact checking, making sure his results had been published in reputable journals, and add in competing devices. Or just offer the event as uncertified CME. One person pointed out that, if it was the only treatment for that disease, he could make an argument for Dr. Gray Matter being OK to use.

I missed some of the beginning stuff in this session, like the definition of speakers bureau and the regulations that affect speakers bureaus (I came in just as Debra Gist, consultant, was finishing up on the regs part and was recommending that people check out my article on the Phase II rules of the Stark Law—thanks, Deb!) . I’ll post more when the presenters e-mail those slides to me. Here’s the part I caught.

Maureen Doyle-Scharff, Abbott Laboratories, outlined some of the realities pharma companies are dealing with that impact their speakers bureaus:

* Budgets are being cut across the board, not just for CME but everywhere.

* The firewalls between marketing and medical affairs can create confusion when it comes to key opinion leader services.

* Pharma is trending away from “road shows” (i.e., visiting professor programs).

* Investment in single, standalone events is viewed as less risky.

* Some companies are beginning to differentiate between promotinal and independent speakers.

“It’s turning into a ‘read our minds’ situation,” she said. “We don’t want to have anything to do with speaker selection. Don’t ask us.”

The good news, she said, is that we all are beginning to recognize that faculty need training on what is and is not appropriate. In fact, industry is “champing at the bit for this”—”this” being a formalized training program that will walk faculty through what they can do in each setting. She said that one component of a training program that should be rolled out later this year (I’m not sure who, exactly, is developing it, but from what she said, it sounds like a cooperative effort between industry and some of the major players on the CME side), will be a certification that the faculty member has gone through the training and has agreed to follow the rules.

Every major pharma company that was at the table plans to rquire any individual who serves as faculty to go through this training, she said. “Many of the CME providers also said they won’t use faculty who haven’t gone through this training. It could come down to pharma companies not being willing to support any activity whose faculty haven’t gone through this training.”

Nathalie Harden, with Health Science Communications Health Science Center for CME, then spoke about how to partner effectively in joint or co-sponsorships in today’s “overly regulated environment.” Why partner? “We need to to survive. We’re all vying for the same funds. Partners can request grants together and share the pot.” Partnering also can help match one company’s strengths with another’s weaknesses.

The biggest obstacles, she said, were ineffective early communication, misunderstandings about what roles each partner will play, and a lack of documentation to cement the deal. She recommended talking with partners early and often, exchanging written policies, and creating realistic timelines that meet each partner’s needs. Know who’s in charge of what, and whose resources are best suited for each aspect. Create a process for resolving issues that come up, and don’t rely on verbal agreements. Have each provider sign a collaborative agreement and share it among all the stakeholders.

The Q&A mostly revolved around the faculty training program Doyle-Scharff talked about. I asked if there would be any consequences for not living up to the agreement to live by what they learn, and there aren’t any built into the program itself. But Doyle-Scharff said that CME providers hopefully wouldn’t use faculty who haven’t gone through the training, or who violate what they learned. Mark Schaffer, EdM, Thomson Professional Postgraduate Services, also a presenter, said that the purpose really is to educate the faculty, because a lot of them really don’t understand the difference between promotional and educational events. He believes that they want to behave correctly, and will once they understand where the lines are drawn.

The topic of whether companies are cutting back on promotional meetings also came up. Schaffer said that physicians tend to like certified education better than promotional meetings, and that companies are cutting back on promotional meetings because they’re recognizing that fact. Doyle-Scharff said that some companies are in fact cutting back on promotional meetings, something that doesn’t break her heart. “I believe educational meetings have more value than a commercial. But doctors do like the promotional meetings.” Another pharma person in the audience pointed out that the amount spent on promotional versus educational events really depends on where a specific product is in its life cycle. If it’s close to being launched or newly launched, the budget will increase for promotional events, and decrease over time.

Van Harrison, who was in the audience, piped up with a question about policies on paying for training for educational speakers. Do they get honoraria? Schaffer replied that his company doesn’t pay for them to attend, but it does pay their airfare and living expenses, just not lavishly, so it’s a budget-neutral thing for them to attend.

There also was some back-and-forth about the value of national versus local speakers. Is it really worth it to bring in a big name, big money speaker to do a hit-and-run lecture, or is it better to rely on local experts who are better known to the audience and will be around to answer questions after the event is over? Schaeffer pointed out the obvious: It depends on your audience.

This free-for-all, no-holds-barred CME provider/industry dialogue, led by Maureen Doyle-Scharff of Abbott Laboratories and Mike Saxton with Wyeth Pharmaceuticals was pretty lively, to say the least. It was pretty much all a back-and-forth between the pharma and CME people in the audience, so I’ll just do my notes up as a Q&A (there sometimes were several A’s to each Q). Here goes:

Q: As companies move to online systems, some have also gone to an online contract. According to the Standards, we need an actual signed contract, not a virtual one. Is pharma working with ACCME on this?

A: The short answer is “no.” You’ll get a different answer from every company in this room. The dialogue is only happening on an individual basis, and at this meeting.

A: The closest thing to it is the Task Force (on CME collaboration), which has asked if we can be on the same page with some of the basic documents. Keep in mind that these online systems were built based on compliance [with OIG and PhRMA] compliance only, not ACCME regs.

Q: What can a CME provider do to make their application stand apart from all the other proposals in the Web-based system?

A: Quality, basically. Outcomes, needs assessment, objectives, methods. Another fundamental is that it’s aligned with our research interests.

A: We expect to get between 10,000 and 24,000 proposals this year. Short is good. Needs assessments are very important, too. The main reason we turn grants down are that they just present a need for a lump sum and don’t break it down into what will be spent for each faculty, for example. Also, we don’t give grants if meals are over $100 per person.

A: Don’t ask for meals, just educational expenses.

Q: The online forms are mainly geared toward live meetings, which makes it next to impossible to find the right fields for enduring materials or Internet activities.

A: Every week we have meetings on what we need to change. Give us some time; we’re still working it out.

Q: Are there limits on grant size that can go through an online system?

A: Our Web site is for smaller proposals; anything over $50,000 is given to managers to handle.

A: For us, it’s anything over $10,000.

Q: Is there any value in putting in a $9,999 request, then, to keep it under the threshold?

A: We see more of the opposite: If you have a proposal for $12,000, we may ask you to push it down to $10,000 to get it through faster. If it has to go to a manager, then to a committee, it will take longer.

Q: A lot of times we ask for $10,000, and they come back with, “we’ll give you $5,000.” Also, it’s hard to find the right Web site. Is there some way to find the right place to go?

A: Both the Alliance and the Task Fore are talking about developing common letters of agreement, which I don’t see happening. More likely, they’ll publish a guide to the right place to go. It’s one way to help you sort through the clutter. Cojmjpanies will have to wade through a lot of red tape, but I’m dedicated to making it happen this year. But it won’t be comprehensive, because some companies won’t agree to do it.

A: Call PACME members directly. They’ll help you if they can.

Q: Is there any hope for a topic that’s not product-related to get funded? Like medical ethics? If so, who would fund that?

A: Merck. There’s a list of “other” topics they’re willing to support on their Web site.

A: Does industry view this as a charitable contribution or as a return on education? We fund a lot of charitable contributions, and that might be one of them. But keep in mind that charitable contributions are only maybe 3 percent of our budget. The bulk of the money will always be evidence-based medicine areas related to our product areas.

A: We stick to areas of educational interest. There are broad interests, sometimes, like multicultural disparities, that we can support. What trips us up are topics related to practice management—we’re uncomfortable going in that arena.

A: Nontraditional topics may still have value to us. But you need to do more primary research during the needs assessment.

Q from pharma: We don’t have an online grant process yet, but we will by the end of the year. Could you give us the five things we need to keep in mind as we build that system?

A: Logical budget item entry.

A: Entries that allow enough characters in the field, or the ability to upload.

A: Flexibility in allowing providers to propose programs other than live events.

A: Make it stable (BIG applause on this one).

A: Make it saveable, and don’t let it time out on you.

A: List the company’s main research areas that are open to funding at the present time.

A: Ability to upload budget, agenda, needs assessment, etc., so we don’t have to re-input it all.

A: Save some of the basic information in the template so I don’t have to re-input it every time. Also, give us some idea of whether it actually went through and where it is in the process. Also, why a grant was rejected (pharma replied that that’s not going to happen, due to the sheer volume of requests they get).

A: A phone number to call for troubleshooting (one pharma person said, “I didn’t understand when I was a provider how much money it costs us to give away money. I would have to hire five more people to answer all those calls if we installed an 800 number).

Q: We have heard that some field-based personnel are coaching some providers on how to get a few steps up on the online process. Is this going to continue?

A: This shows there’s still a need for compliance training. Alert the company when something like this happens.

A: We would want to know if there was any coaching going on.

Q: I want to know about location. One of our hospitals is in the Florida keys, and they want to have the CME in their own backyards, not to have to travel to the mainland for it. It’s totally unfair that I get penalized for living in a beautiful place.

A: I would document your reality, in detail, in your grant request.

A: The tendency is to see “resort” and “Keys” and turn it down. Show how it’s an appropriate exception.

A: If you were in Iowa (not to pick on Iowa) and wanted it to be in the Keys, we would get nervous. For people in that circumstance, I would suggest restructuring your meeting so instead of having a five-day, four-hour/day meeting, have a two-day intensive on Thursday and Friday, and let them do the weekend on their own.

Q: We go to a nice place, but we go off-season, and we go all day long, every day.

A: Remember that it’s about perception, not actual costs. That’s why any application with “resort” in it will be kicked out. I don’t care if you got a $59 room rate and you went 24/7. All that would get printed in the paper is that you went to a resort. Some brand hotels are off-limits, period. It’s all about perception.

Q from pharma: We’ve been talking for almost an hour now, and it’s all been about money. We get tired of being your money pit. Isn’t there anything else you want to ask us about?

Q from CME: What market research can pharma give us that we can use for our needs assessment?

A: We couldn’t provide any.

A: As a provider, I remember drooling over that data. But our lawyers won’t let you have 95 percent of it. But ask anyway, because we want to show our lawyers that it’s important to share it, as long as it’s done right.

A: The amount of time it would take to go through all the data would prohibit this, since we can’t share anything that’s product-related, which most of it is, and rightfully so.

A: Find the info that’s published in clinical trials. You’re supposed to come up with an independent needs assessment.

We ran out of time at this point, but tomorrow (Saturday) there’s another three-plus-hour session on this kind of stuff that I plan to attend, so more is on the way (I feel like the pharma queen at this conference—for some reason, I’m going to all the pharma-focused sessions. But that’s OK, because they get pretty rowdy.)