Can you imagine getting a memo from your hospital s compliance officer telling you that you can t provide more than $300 per year of CME to a physician that refers Medicare/Medicaid patients to your organization, and that you have to have the commercial supporter cut the check directly to faculty?

Believe it or not, that memo did go out to an organization recently, according to Denver attorney Jim Miles, of Miles & Peters, PC. It was in reaction to the Stark II regs I wrote about last week.

Stark II, which is aimed at ridding the system of Medicare and Medicaid abuse and fraud caused by hospitals or other organizations that handle Medicare/Medicaid patients wooing their best referrers with perks, firmly places CME in the perk realm, much to the dismay and annoyance of providers I ve been speaking with. Up to $300 per year can be exempted from the rule, or so it appears in the vaguely worded document after that, you risk noncompliance. Maybe.

Miles says that it s all a tempest in a teapot and, basically, don t worry about it. Here s a boiled down version of his reasoning (some of it will make it into the article for the next issue of Medical Meetings, but there s never space to say it all, so I ll blog it instead):

[Communication company s] services provide pharmaceutical companies cost effective access to physicians, augmenting their existing sales and marketing activities. Additionally, [Communications company] enables physicians to conveniently learn important and relevant information about product and treatment options from thought leaders and their peers in an interactive environment, which physicians prefer.

While pharma has been going to great lengths to emphasize the separation of church and state, it sounds like some companies who service them still are not. It almost sounds as if the actual education is tacked on, just an “additional” benefit to the sales and marketing aim of putting docs and pharma together.

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Move over pharma: Now that so many foods are making health claims, is it any surprise that organizations like the California Walnut Commission are getting into the healthcare education game? (Walnuts are supposed to contain Omega-3 fatty acids and other “good” fats.) CWC, for example, is supporting a curriculum at an Alabama hospital to teach nurse practitioners about healthy fats, according to this article.

In addition, physicians employed by food companies are presenting information at medical conferences. This month, at the American College of Obstetricians and Gynecologists annual meeting in Philadelphia, James Greenberg, an obstetrician gynecologist at Brigham and Women’s Hospital in Boston, made a presentation about the benefits of cranberry juice cocktail for preventing urinary-tract infections. Dr. Greenberg is a paid consultant for Ocean Spray Cranberries Inc. Ocean Spray says it has long conducted research and marketed health information to consumers, but that in the past couple of years it has refocused energies on physicians.”

With all the new regulation relating to what pharmaceutical companies can and can t do in relation to medical meetings (go to mm.meetingsnet.com and search for PhRMA Code, OIG Guidance, AdvaMed Code, and Standards for Commercial Support for articles on the regs), it seems it would just be a matter of time before food company sponsorships and speakers will come under fire as well.

Or maybe not. According to the article, “The new approach to food marketing comes at a time when regulators are making it easier for companies to advertise health claims about their products.” While they used to only be able to advertise their products health benefits if the FDA agreed there was conclusive evidence, as of last year FDA began to allow “qualified health claims” for products that just have limited and preliminary scientific evidence.

Consumer advocates say the marketing tactics are raising some of the same ethical concerns that have drawn widespread criticism in the pharmaceuticals industry. For years, drug-company sales representatives have lavished gifts upon doctors, including golf vacations, cash and expensive dinners in an effort to get doctors to prescribe specific brand-name drugs. While the food-industry marketing tactics aren’t at that level, gifts, grants and sponsorships from food companies given to doctors or medical organizations are triggering similar concerns.

And it gets even more convoluted, says the article, with food companies working with pharma to bundle coupons for their products in with drug samples given to docs. And they re exhibiting at medical conferences now, too.

Oy vey.

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Even though the pharma giant s spokespeople keep insisting that it had already disseminated all its clinical trial data at meetings and other means including negative data GlaxoSmithKline PLC still “agreed Thursday to release negative data on the safety and effectiveness of its drugs to settle a lawsuit by New York’s attorney general that accused the pharmaceutical maker of misrepresenting data on prescribing its antidepressant drug Paxil to children& The London-based company is the first major drug maker to agree to disclose all its studies. The company also will pay $2.5 million to the state as part of the settlement.”

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While the difficulty in getting foreign physicians into the U.S. for meetings continues to be a problem, there s at least some some good fallout from this policy.

Before doctors such as Mircea Rachita from Romania came, patients in the small timber town of Roseburg had to wait months for medical appointments.



Now, underserved communities are finding good doctors easier to come by because of a visa-waiver program that creates incentives for foreign-born physicians to work in communities that U.S. doctors shun.

I would also hazard a guess that it s proving to be a boon for meetings held outside the U.S. as well, especially for specialties whose U.S.-based societies don t have a well-established reputation.

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The American Cancer Society is beta-testing a new PDA-based educational tool called C-Tools 2.0.

Saying that it is designed to provide physicians with instant access to the most recent cancer information, the tool will be “available free of charge to anyone in the health care field.” It will be offered in both Palm OS and Microsoft Pocket PC versions. “All clinical content for the software has been developed and reviewed by physicians, the American Cancer Society National Health Promotions Review Board and additional cancer education professionals. The software program will be a complete collection of the most recent cancer facts, findings and information.”

Starting in January 2005, the tool will be available free of charge to anyone in the healthcare field.

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The almost 50,000 medical students who belong to the American Medical Student Association are being urged to join in on a national campaign called The Amnesty Campaign. The idea is to collect everything that pharma has doled out to them from pens and Post-it notes to mugs, calendars. According to a press release:

“The campaign is the first in a number of events leading up to National PharmFree Day, which will be recognized on December 8, 2004. National PharmFree Day will serve as a day of action where medical students, residents and physicians alike to speak out against the pharmaceutical industry’s biased marketing practices.



“ The pharmaceutical industry has ramped up its spending on marketing dramatically over the past few years, says Brian Palmer, M.D., M.S., M.P.H., AMSA national president.  As physicians in training, AMSA believes that prescribing decisions should be made on evidence instead of marketing. The collective effect of these giveaways is to drive up drug costs and hinder evidence-based medicine.

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War and corruption has a lot to do with why the Iraqi healthcare system is in such rough shape right now, but so does a systemic lack of medical education, according to USA Today.

“Medical care was locked in a time warp in the ’70s because doctors couldn’t attend meetings or obtain journals.  The isolation Saddam (Hussein) put them through was a kind of terrorism itself, [Jim Haveman, President Bush’s newly appointed health advisor to the provisional authority] says.”

The authority has a lot of work to do to live up to its pledge to restructure Iraq s healthcare system, and increasing medical education access, while just one piece of the puzzle, can only help. But with today s visa hassles, chances are Iraqi docs won t be coming to the U.S. in droves to get that education, and it s doubtful that many non-Iraqis will be heading to that war-torn country until it stabilizes, especially now that Doctors Without Borders has pulled out.

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According to a report on eurekalert.org, “Physicians appear to be performing surveillance colonoscopies at frequencies higher than those recommended by evidence-based medical guidelines, according to results of a survey conducted by the National Cancer Institute (NCI), part of the National Institutes of Health& These results, which appear in the August 17, 2004, Annals of Internal Medicine*, suggest that as the demand for colonoscopies in the United States increases, overperformance could use up limited physician resources and cause unnecessary risk to patients.”

Part of the problem, it seems, is that the physicians are getting information that conflicts with the guidelines from clinical evidence in scientific journals. “Information obtained at medical conferences or meetings also was perceived as influential. The authors noted that one problem may be that different medical groups have somewhat differing recommendations, so doctors do not have one single source to turn to for practice guidelines.” The study said that 80 percent of the surveyed physicians “said scientific evidence was significantly more influential than medical guidelines.”

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The Stark II law, which just went into effect a few weeks ago, has to be one of the most frustrating documents I ve dealt with in a while. Sponsored by U.S. Congress Representative Pete Stark, the revisions focus on many aspects of Medicare/Medicaid, including potential fraud and abuse on the part of hospitals that have rewarded physicians for referring Medicare/Medicaid patients to them rather than to competing hospitals. These rewards have included sizeable dollar payments per patient, free parking in hospital structures, free meals, free travel, special gifts and now, says CMS, CME falls under the same umbrella. Maybe.

It s all pretty vague: “In many cases, the provision of CME to physicians could constitute a benefit of significant monetary value to physicians. CME may be covered under the non-monetary compensation up to $300 exemption,” according to the Federal Register document. The other direct mention of CME in the comments portion of the document is in response to a hospital association s question on benefits that can t fit into the $300 exception, including “Free continuing medical education or other training at the hospital. [The commentator noted that hospitals often obtain educational speakers free of charge, thus enabling them to provide low-cost training.]” The response was: “The free CME could constitute remuneration to the physician, depending on the content of the program and the physician s obligation to acquire CME credits.” So it depends on whether it s accredited CME or not?

When I contacted CMS, they weren t about to give me an answer to that question (or my many other questions), saying that “We really can t work in hypotheticals there are so many variations on the facts of the various CME arrangements that it would not be possible [to provide] one-size-fits-all answers.” Fair enough, but that still leaves providers especially hospitals in limbo. If they don t comply, they get nailed to the tune of $15,000 per occurrence, according to one attorney I spoke with. But there s no guidance telling you specifically how you can comply.

And why on earth is CME lumped in with holiday gift baskets and parking spaces as a perk? The whole point is to improve patient care: Isn t that what CMS wants? And the Catch-22 is that CMS Medicaid/Medicare reimbursement is moving toward a “pay for performance” standard for reimbursement, meaning that hospitals and others who receive reimbursement from Medicare/Medicaid will only be reimbursed as long as they can prove with data that they meet the standard of care. So let s penalize hospitals and other providers who provide education to physicians so they can do just that?

This makes no sense to me. If you have any information, please post it by clicking the “comment” button below, or e-mail me.

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