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Pharmaceutical Industry Disclosure Practices

Beyond the firewalls
by Marc Iskowitz, Medical Marketing & Media (August 1, 2005)

Pharmaceutical companies have rewritten the rules for supporting medical education in response to mandates demanding content is insulated from marketing influence. Meanwhile, providers are reporting mixed experiences dealing with a bevy of complex funding systems. The result seems to be a fresh commitment to providing CME that is as effective as it is compliant.

April 28, 2003, stands out as one of those seminal dates in pharmaceutical regulatory history. On that day an important document came across the desk of many pharma executives. Although technically not a mandate, the communique effectively told pharma how to handle what is now a billion dollars a year of investment in continuing medical education grants.

The directive of the document--Compliance Program Guidance for Pharmaceutical Manufacturers, from the Office of Inspector General (OIG) of the Department of Health and Human Services--was to separate med ed grant-making from marketing and sales.

Some companies had already roused to the importance of this. Wyeth Pharmaceuticals formed a discrete division--Professional Education Support (PES)--to administer grants back in 1999.

Nevertheless, the guidance "was a significant change that led to us establish a separate policy for grants and donations," recalls Anthony Iacono, PES assistant vice president.

Today PES plays a central role in a new policy designed to ensure that Wyeth's involvement in CME programs does not compromise their independence. All contacts with the CME provider pass through PES, and grants are decided by a committee consisting of a doctor, lawyer and PES member.

Wyeth is one of about a dozen pharma companies, including AstraZeneca, Bristol-Myers Squibb, Merck and Pfizer, that have revamped the way they handle CME in the wake of the OIG guidance. These firms have erected nationally centralized med ed support structures. Common among them is a central intake point for all requests, often in the form of a Web site or phone number. (Wyeth's central site, grantsanddonationsúwyeth.com is set to go live this month.) Sales reps at these companies no longer have authority to give gifts for CME. Instead each firm has assigned responsibility for decisions on financial gifts to a unit responsible for educational, professional or legal functions.

Well-defined funding criteria are the norm. Wyeth's PES carefully delineates permissible involvement, such as suggesting general topics if asked by the CME provider. "Marketing can see the grant, but they do not have a vote on whether or not it's supported," Iacono says. "We look at [requests] from the point of view of whether they're strategically aligned, and we have a budget."

To help make such decisions, Wyeth bolstered competency in PES recently, bringing in veteran industry hand Mike Saxton as executive director. Saxton has 17 years of CME experience in a variety of settings and 23 years in pharma. PES senior director Jennifer Smith, Ph.D., another recent hire, joins after a five-year stint as executive director of the FCG Institute for Continuing Education--an accredited CME unit of Sudler & Hennessey--and one year as president, continuing education, at Scios. "We have moved to an age where compliance is a minimum standard, and we also want to see that [a proposed activity is] effective," says Saxton.

So far 11 pharmas have reorganized, but until that number doubles, sorting through the myriad of processes on a company by company basis has providers vexed.

"It's a moving target," notes Don Stewart, chief marketing officer, International Meetings & Science (IMSci.), a non-accredited meded unit of Grey Healthcare Group (GHG). "Different [ pharma ] companies have understandably dealt with [the OIG guidance] in different ways. Some have possibly gone beyond the guidelines in separating marketing from having any influence in CME events. Other firms have interpreted the guidelines less absolutely."

Indeed, some are supporting education through decentralized brand teams, others have a compliance-driven program, and still others have created the early stages of education units. Providers report coping with ever more complex processes to get funding.

"Our funders have built this regulatory fortress, and it can be nearly impregnable," observes Eric D. Peterson, Ed.M., vice president of the Academy for Health Education, a division of the Impact Group. Money is there, "but you have to work a lot harder for it."

That means lengthier planning cycles as multi-level, multi-disciplinary grant committees pore over requests. One provider said the process of preparing the grant application and receiving the approval takes anywhere from four to eight weeks. Lead time to do a symposium is almost a year.

A less direct channel of communication with pharma is one reason for the protraction. By moving the grant request process in house, some pharmas have eliminated the field-based medical science liaison, the individual responsible for collaboration between industry and CME provider. Rapport has not been the same.

"I could name at least five companies where the liaison with us has left the company due to the reorganization in the last two years," reports Nancy Davis, Ph.D., director, division of Continuing Medical Education at American Academy of Family Physicians (AAFP). "That shakeup has really affected our relationship with the industry."

Davis believes that the lack of a relationship with the local pharma rep will impact smaller, community-based providers the hardest, such as hospitals and medical schools. "Certainly our local chapters are feeling that," she notes.

Grantors acknowledge that the changes have added layers of bureaucracy to what was once a relatively uncomplicated system.

"We have taken what used to be a fairly simple process, especially when CM E was supported through unrestricted educational grants, to a very complex process that is starting to weed out the providers who are not large enough from a human resource capacity to deal with and manage these processes," says Maureen Doyle-Scharff, director, professional services and medical education at Ross Products, a division of Abbott Laboratories. "Relatively speaking, the process is just very cumbersome. So it's harder to offer the support."

These moves come as support from FDA-regulated companies reached $1.04 billion in 2004 and total revenue of the CME enterprise peaked at $2.04 billion (see Fig. 1). As CME grows with regard to commercial funding and available offerings, the industry acknowledges a growing need to protect content from bias.

Marty Cearnal, chief strategy officer at Thomson Medical Education, says providers have to think like a pharma executive to get funding. He cites two criteria: that it is safe from a regulatory stand-point to support the activity; and that the activity aligns with a research interest that can be justified to pharma's shareholders.

"I call that the reestablishment of 'safe harbor,'" says Cearnal. "That's not an area where any kind of behavior is sanctioned but an area where companies can feel if they are acting appropriately they are not putting themselves at risk."

However, he says, "companies are not sure how to act and not put themselves at risk, and the net result of that is no action or little action. So it's hard for any of us in any situation to cope efficiently and effectively in an environment filled with uncertainty."

According to the latest data from the Accreditation Council for Continuing Medical Education (ACCME). The amount of funding coming from FDA-regulated commercial sources shot up $100 million to $1.04 billion from 2003 to 2004, an 11 percent gain, according to ACCME's 2004 annual report. However, that's less than half the 31-percent increase from 2002 to 2003. Reflecting this slowdown in support, the proportion of revenue from commercial sources (gifts and exhibits) dropped from 65 percent of to 62 percent in 2004.

As other pharmas centralize their funding systems, Peterson predicts funding will increase. "It's just that we've seen this period of paralysis while the whole system adjusts to the new reality," he says.

The slowdown is difficult to quantify. R. Van Harrison, Ph.D.. a professor in the Department of Medical Education at the University of Michigan Medical School, has tracked companies that have instituted new systems. "Each [ pharma ] company that has changed its procedures has stopped the flowed of funds one way and started it in another, and there has been a lag time in between," he says.

No one knows the effect this lag time will have on the overall level of CME funding, or whether funding among these firms has been fully restored. Complicating the picture, many academic centers report on a year that ended in July 2004, so the numbers don't reflect what might have happened to their grant funding in the second half.

ACCME guidelines for providers

Providers, meanwhile, are wading into regulations of their own, designed to prevent faculty members and others participating in CME activities from biasing content. ACCME issued a revision to its 1992 Standards for Commercial Support last September, which became effective in May this year. The intended effect: require disclosure of commercial ties by anyone in a position to influence content and resolve any conflicts prior to the activity.

Most providers say they already had procedures in place to prevent commercial bias. But the broader disclosure requirement now affects people other than faculty, like medical writers.

"If your edits alter the content, even if it's just copyediting or proofing, you have the ability to influence content," says Marissa Seligman, vice president, programs and compliance, Pri-Med Institute. "Then you have to provide disclosure."

Acknowledging that such conflicts are "a natural consequence," Murray Kopelow, M.D., chief executive of ACCME, is trying to focus providers on two stages: conflict identification and resolution.

To determine the existence of a meaningful faculty member conflict, he says, providers first must check for the relevancy of the relationship. "Just because [a faculty member] has a relationship with a firm or speakers bureau doesn't necessarily mean there is a conflict at this educational activity." If a conflict exists, make sure the presentation is truthful (a set of content validity statements, available from ACCME, can help) and ensure safeguards are in place to ensure commercial bias will be absent from the presentation. These considerations "trump everything," Kopelow says.

ACCME has said that the response to a conflict should be proportionate to the problem. Having commercially disinterested peers review content and referencing best available evidence in the literature are two of the tactics providers can use to manage a moderate commercial conflict and still preserve speaker participation.

"People didn't first understand how easily they could resolve a conflict of interest," Kopelow explains. "We gave examples, and then we gave more examples, of how they could do it. And now people have started to integrate that concept into the way they do CME.'"

Indeed, says AAFP's Davis, "I couldn't imagine eliminating a faculty member from a CME activity if they have a conflict of interest. Whatever the conflict is, you can resolve it through peer review."

However, ironing out conflicts among CME planners and peer reviewers for enduring CME materials is another matter. "If you have a planner with a conflict, you don't have much of an option except to eliminate them from the planning process," she says. "We're finding that a bigger obstacle. With a faculty person, you can review their content, but with a planner you can't." Using evidence-based content is one way to protect against bias in these instances. However, collecting disclosures and evaluating conflicts presents an "administrative burden," Davis says.

The problem, notes Seligman, is that "there's no landscape, no roadmap," to complying with the ACCME guidelines.

Kopelow has tried to chart a course and predicts that, "As in everything that is new, I would expect with experience, the system will be streamlined." He says he finds it "very gratifying" that both sides--the accredited providers and the commercial supporters-are addressing the ACCME requirements and working to ensure the independence of CME.

A fresh commitment to content

Despite grumbling on both sides, the changes among pharmas and providers have proven to be a catalyst for a fresh commitment to producing content that not only is compliant but also is effective at changing physician behavior.

"A lot of people in the industry are recognizing the unique contribution that medical education--CME specifically--can make in the future for the pharmaceutical industry," says Wyeth's Saxton. "It's a very responsible, effective way to fulfill our mission to accelerate the adoption of evidence-based research."

As pharmas alter their DTC communication to convey risks more clearly and run more disease-awareness ads, medical advertising agencies have sought to cater to them. Most have split promotional med ed shops from accredited providers in their networks, and some have even bought providers to enhance their portfolio.

GHG's Stewart says agency networks can deploy these units as needed. "Generally the way it works is if it's a promotional program, IMSci. will be engaged to do it, and if it's a CME program, then [for-credit GHG division] CME Scholar will be engaged. Both groups can draw off the same technology, but one takes the lead depending on what type of education it is."

The firewalls between two of Publicis Medical Education Group's med ed holdings are even thicker. "We're on a separate phone system than [promotional unit Discovery Group], even though we're in the same building," says Don Young, head of Discovery Institute of Medical Education (DIME), a for-credit unit.

While Young says he sees support growing, "More is being asked of us up front in terms of better documentation in needs assessment, outcomes measurement, and metrics we would put in place."

According to IMSci's Stewart, these requirements are being applied to promotional med ed, as well, to improve its credibility.

Allocations overall are moving toward multifaceted initiatives that include sophisticated outcomes measurements, enabling providers to measure if they are really making a difference.

ACCME requires providers to evaluate CME activities, and one of the criteria for earning a commendable rating is that they go beyond the usual satisfaction index--pre- and post-tests--to the looking at changes and improvements in provider behavior.

" Pharma has become aware that this is an important issue," says Linda Casebeer, Ph.D., president of Outcomes Inc. "Not only for providers in terms of their accreditation, but because the data is useful in better understanding what is effective in CME.'"

Outcomes Inc. works with pharmas on their larger educational initiatives, often looking at a series of events in a particular clinical or disease-management area and the effectiveness of those educational events in improving physician performance and patient health outcomes. The most effective learning methods are changing as physicians' information-seeking habits shift, notes Casebeer, who is also associate professor in the Department of Continuing Medical Education at the University of Alabama Medical School.

She says a six-year study UAB has done with Harvard University Medical School shows physician information-seeking habits have changed fairly radically. The lines are often drawn by specialty, between physicians that have a broad knowledge base--family practitioners and primary care physicians, and to an extent ER doctors and Ob/Gyns--versus those with a narrower one, like specialists and sub-specialists. The latter seek information on the latest trial data, most often relying on their specialty societies and on portals like Medscape that rapidly update information. PCPs most often search for information in response to a problem they see.

Across both groups, live meetings are less well attended than they were five and 10 years ago. At the same time, there has been a significant increase in anything physicians can do on their own time, including eCME, CD-ROMs or monographs. These trends reflect in the ACCME 2004 data (Fig.2 [not included]), which portray eCME as the fastest growing area of reed ed. with about 14 percent of CME registrants.

"The shift among ways physicians seek medical information, largely due to the Web and the explosion in medical information, has [altered] fairly dramatically how physicians seek CME credit," Casebeer says. "'At the same time.., we need to watch carefully what's engaging physicians and what's influencing what they do in their practice."

Providers are doing their part by creating CME that harnesses new formats. BioScience Communications, a med ed unit of Edelman, champions use of technology in live symposia, such as keypads for audiences to respond to questions. Mark Deitch, BioScience global managing director, says such technology relieves wear on audiences, although "good and important science presented by the top people in the field" is still the best way to attract clinicians.

Summit Grey, a technology startup of GHG. added a new twist to the medium with its HyperCD, a disk that directs users to a Web site where they view online interviews with thought leaders, video and animation. Following an American Heart Association meeting last year, Summit Grey produced a HyperCD for Celebrex and packaged it in seven medical journals. Subsequently. while 250 doctors attended the AHA meeting, through the HyperCD "'we were able to extend the audience of that symposium to more than 40,000 physicians," reports Sharon Callahan, Summit Grey president.

Seeking to keep up with new formats, most med ed providers work with other technology shops. One, mobile software firm ePocrates, has given busy physicians a way to earn CME credits by downloading courses to a handheld device. Doctors read an article and can take a test. Test results are updated when the device is synchronized, and physicians can submit the activity for CME credit.

A miniscule but innovative group of providers report moving toward practice-based activities. The AAFR in tandem with the American Medical Association, has been awarding credit for so-called self-directed learning, in which physicians search the literature via a database system to find answers to questions generated by patient interaction. The groups started a pilot four years ago and launched their separate services this year. Two other self-directed programs, Stanford SKOLAR and MerckMedicus CME Program for Searching and Researching, arc similar.

After completing an CME activity, relatively few physicians ask for credit, even when available. That's because they have so many options to get CME, says Callahan. "Even at live dinner meetings, we get maybe 15 or 20 percent asking for a certificate ... What the CME really does is lend credibility to the program."

Destry Sulkis, MD, managing director of CME at Medsite, says he's seen higher rates of clinicians registering to get credit. "Overall we see a 63-percent completion rate and a 33-percent credit rate."

Sulkis attributes that to Medsite's case-based methodology, using simple HTML and occasional graphics. "'It's the way [physicians] were trained in medical school, residency and fellowship."

Callahan says providers can boost participation in eCME by marketing it better. But Bernard M. Sklar, M.D., notes in his June 2005 research that eCME use is still low because much live CME, especially at hospitals, is convenient, free and offers collegial interaction.

The predominance of text-based instruction in eCME bothers others. "In our research physicians have been very disappointed by eCME," Callahan says, citing data from Sklar that just 18 percent of eCME programs employ case-based interactive learning. Most are text only (34 percent) or text and graphics (23 percent).

"Even in a world where everyone has broadband, some want to read material," counters Steve Zatz, MD, executive vice president, professional services for Medscape, a unit of WebMD. "You're always going to see a mixture of learning styles."

Zatz says the majority of Medscape content integrates graphics, sound or video. The portal includes some nice features, such as conference coverage, as well as offering CME credit in some cases for reading medical news. Medscape's editors select which news stories to accredit, along with specific journal articles.

Innovative CME also suffers from a lack of funding, often due to relatively small numbers of participants. A new AAFP Web-based activity, Measuring Evaluating and Translating Research into Care (METRIC) is designed to assess physicians' improvement in practice by having them input data from patient charts at baseline and after six months. A diabetes module launched in January but has just 140 users. "We are trying to put out two modules a year and are having trouble finding the support we need," Davis says.

Casebeer laments the situation, adding, " Pharma tends to invest in similar products because that's what CME providers bring to them. Other formats are greatly neglected, even though evidence shows they are highly effective with physicians."

However, "As data accumulate and pharma begins to pay more attention to the data already there ... it's my hope we will see investments in formats that are most effective," she says.

Ongoing dependence on commercial support

Though support is unsubstantial in some sectors, most of the industry continues to be very reliant on pharma funding (Fig. 3), some say at the expense of independent CME.

Little consideration has been paid to the cumulative effect of bias in the topics chosen for presentation, even if the content about the topics is not biased, the University of Michigan's Harrison observed in a paper published in 2003 called "The Uncertain Future of Continuing Medical Education: Commercialism and Shifts in Funding." In it he argues that the overall curriculum of courses providers address is being biased to get funding. Steps should be taken by medical societies, oversight bodies and physicians themselves to reduce the funding influence, he says.

Harrison also explores what would happen in the event of a drop in future commercial funding when the Medicare prescription drug benefit takes effect. Medicare, he says, will reduce the amount paid for drugs, lowering pharma's interest in marketing to physicians. "Within the medical community is an ongoing debate on the extent to which the CME 'system' would collapse without commercial support," Harrison says. He doesn't think it would, "but different parts of the system would be affected by varying degrees."

Notwithstanding these warnings, most recognize the positive consequences of commercial support--more rapid knowledge diffusion about new products and technology. Considering the marked decrease in CME funding from medical schools over the years, commercial funding could be CME's best source for longevity.

As one agency-based provider said, CME may be undergoing an upheaval, but it's never going away. With OIG restricting other kinds of marketing practices and pharma committing more to disease-awareness, CME remains an acceptable and highly relevant medium. The industry seems to be turning the quality corner just in time, even if it hits a few bumps along the way.

"I applaud the industry for taking this more seriously than we ever have before and doing it right," Ross' Doyle-Scharff says. "The question is, have we figured that out yet?"

Challenges of global CME

Is CME going south? Barbara Pritchard thinks so.

Pritchard is president of Intermedica, a firm whose purpose is to bring the best of U.S. medical education content to physicians and patients in Latin America and elsewhere around the globe. Intermedica works with its live meetings company LiveMed to produce symposia other medical education events. Associations typically partner on the meetings, which are funded through local pharmaceutical sponsorship.

"Latin American physicians are hungry for really good medical education, particularly developed [in the U.S.]," says Pritchard.

A thirst certainly was evident at March's International Medical Forum, held in Mexico City (pictured). More than 6,000 primary care physicians attended the two<lay event, listening to lectures by Harvard Medical School professors and Mexican opinion leaders. In 2006, it's expected to draw 10,000 physicians.

Seeking to continue the momentum, Intermedica will produce the International Cardiology Forum later this month in Mexico, featuring specialists from The Cleveland Clinic lecturing to around 2,000 top heart specialists. (The speeches are simultaneously translated for attendees.) And next February LiveMed plans to run a program with the American College of Physicians, bringing internists to Cancun.

Although clinicians in developing countries probably feel a greater desire to hear these physicians, Pritchard says the top key opinion leaders from the U.S. "are well respected and in demand any place in the world." That includes Italy, Spain and Portugal, as well as India, China and the Pacific Rim.

While certification is a requirement in many of these markets, standards for obtaining credits, ensuring quality and regulating commercial support vary or simply are lacking.

" Pharmaceutical companies want their affiliates in other parts of the world to follow the same thing that's done here," as far as separating promotion from education, says Pritchard. "But it's nowhere near that. When we work with a society, we have to explain that a pharma company has to help pay for a physician to attend a meeting, because the physicians don't make that much money."

An initiative, Project Globe, is under way to help address some of these needs. Priorities for the project this year include identifying the CME needs of globalists generally, and starting a pilot group of countries to evaluate the availability of tools and resources to deliver cost-effective, evidence-based CME.

In a further sign of progress, one of the associations partnering on Project Globe, the nonprofit Global Alliance for Medical Education (GAME), met this year under the theme, "Finally, Globalization of CME." However, the meeting's keynote address reflected a more sober view. It was called "Globalization: Curse or Cure?"

U.S. attorneys tackle off, label issue

In a dangerous and potentially costly legal approach, government prosecutors are investigating pharma's off-label communication. The suits arise in the context of a variety of cases, including sampling and drug-pricing, and come either from law enforcement agencies or through whistleblowers.

As a result of the heightened legal atmosphere, pharma is stepping back from funding med ed that discusses off-label uses. "There's a general tendency toward a more conservative attitude on the part of the industry [regarding] promotional activities, because there's more at stake now," says Wayne Pines, president of regulatory services and healthcare at PR firm APCO Worldwide.

Companies must avoid the perception of acting unethically, even if certain legal theories provided firm legal footing in the past. "Office of Inspector General (OIG) has said on many occasions that a commercial supporter can be held liable for [off-label] commercial activity they support with a grant," says Jennifer Smith, Ph.D., senior director in Wyeth Pharmaceuticals' Professional Education Support Department. "It puts us in an awkward situation if we're supposed to be independent and we have anything to do with it." However, she says she would not turn away a grant solely because the activity potentially could contain off-label topics. "We're not willing to block that kind of educational exchange."

While Medicare and Medicaid cover medications prescribed for unapproved uses routinely, and the FDA recognizes that unapproved drug use is legitimate, pharma firms still feel vulnerable. And with good reason. One of the penalties available to prosecutors is debarment from selling to government health programs--a powerful incentive to settle. "For big drug companies, it's the gun to the head; it's your death penalty," says John Kamp, executive director, Coalition for Healthcare Communication.

Last year Pfizer paid $430 million to settle a suit brought under the False Claims Act related to marketing its anti-seizure drug Neurontin for unapproved uses. "If you're a drug company involved in one of these enforcement actions, you cannot take the risk of this penalty being assessed," Kamp notes. "The practical reality here is the prosecutors hold all the cards."

Most ominous to some is the lead prosecutor on these cases-the OIG of the Department of Health and Human Services (HHS) and U.S. Attorneys Offices. "I and some others think the FDA's jurisdiction is being unwarrantedly usurped by this process," says Kamp. "The HHS is doing the FDA's job without consulting the FDA, and I think they're making a mistake."

Promotion of off-label uses constitutes a violation of the Federal Food, Drug and Cosmetic Act, but there are some very clear exceptions. A Washington Legal Foundation case, which dragged on for six years before the courts dismissed a government appeal in 2000, opened up some narrow avenues, including dissemination of certain peer-reviewed journal reprints during details, as long as they state that FDA has not approved the use.

A broader opportunity appears in a 1997 Guidance for Industry: Industry-Supported Scientific and Educational Activities, where FDA says it recognizes that discussions of unapproved uses "can be an important component of scientific and educational activities" and that participants are free to discuss their data or express such views, as long as it is within activities produced independently from the influence of companies marketing products related to the discussion.

"The FDA is an expert agency given the primary role of interpreting the Federal Food, Drug and Cosmetic Act," notes David Adams, a partner in the law firm Venable LLP, and head of its FDA group. Adams also served in the office of FDA commissioner David Kessler. "The concern here is that some assistant U.S. attorneys seem not to be letting the FDA take the lead. Rather, they are being pretty aggressive about expanding the concept beyond the FDA's interpretation."

While off-label communication remains an important regulatory matter for FDA, such promotion usually occurs outside its normal enforcement activities, says Pines. "I think philosophically the FDA is where it's always been, that off-label promotion is inappropriate," says Pines, who was associate commissioner of the FDA in the '70s and '80s. "The issue for FDA is a matter of enforcement prerogative. What do you take action against?"

OIG treads where FDA doesn't, but it does so carefully, insists James G. Sheehan, associate U.S. attorney. Although decisions about whether a doctor can prescribe a non-controlled substance for an unapproved use are generally not regulated by the FDA, "We look to the FDA to say what is a labeled use and for expertise, and then we look to the [government] payers to determine what they will pay for."

An OIG spokesperson told MM&M that attorneys there could not comment on off-label use cases, "since it is in the jurisdiction of the FDA, and when a case involves off-label, OIG works with FDA."

The fact that one agency says it defers to the other offers little reassurance to Kamp. "This is a very esoteric policy area. I'm not sure all the investigators who are general government prosecutors get it."

He adds, "Any time an enforcement agent uses a new interpretation of a law to bring an action, he or she is making policy. The HHS doesn't always have the expertise or motivation to understand the nuances of the policy."

Two legal arguments come into play when deciding whether to investigate and prosecute off-label litigation, Sheehan explains. One is a pricing theory based on the False Claims Act, the other on the mail fraud statutes. He says unapproved-use cases are not an anti-kickback issue. Sheehan takes issue with the contention that he and colleagues are interpreting anew. As prosecutors their job has been to protect the Centers for Medicare and Medicaid Services (CMS) from paying fraudulent claims. "Certain payers have always had restrictions on off-label uses," he says, "and they're often framed in terms of prior-authorization requests."

Answering the call for better outcomes measurement

All accredited providers of continuing medical education (CME) have an outcomes requirement. But not all of them meet it the same way. CME LLC is expanding its outcomes process by taking what it says is a more comprehensive approach to evaluation that eventually will be applied to all of its med ed programs.

"We've been doing outcomes measurement for a long, long time," says Marsha Meyer, R.Ph., senior vice president of clinical information for Irvine, Calif.-based CME LLC. Last year the firm did some 1,200 educational sessions. Surveys and opinion polls have helped it keep its finger on the pulse of what clinicians want to learn.

CME LLC says the new system will widen the aperture, assessing clinicians' needs and prior to an activity. Follow-up will take place immediately after the activity to determine if participants understood the information, and then three and six months on to see if they retain the knowledge and whether they made practice-based changes.

While the system won't be implemented widely until next year, it's already in play in its Lifelong Learning Initiative on Bipolar Disorder, an eight-month CME program running through the end of the year. This initiative, funded by AstraZeneca, focuses on how the primary care physician (PCP) and psychiatrist may work together to care for patients with bipolar disorders. To present each aspect of diagnosis and management, multiple activities will be used, including meetings, teleconferences, online courses and written materials.The pre- and post-tests will CME's bipolar disorder program, pose the same questions to primary care physicians. "We determine the outcomes measure based on what the gap in education was and what we hope physicians will end up using for better patient care," Meyer says.

One aspect of the gap is that PCPs, when they detect a patient is depressed, may not screen further to distinguish between unipolar disorder or bipolar disorder. In a pre-test, physicians said they were aware of the potential for misdiagnosis and of the existence of screening tools. Future tests will ask them to characterize the types of patients they are seeing in their practice.

Over the past few years the Accreditation Council for Continuing Medical Education (ACCME) has encouraged accredited providers to move beyond simple measures of physician meeting takeaways. CME LLC hopes its new measurement tool answers that call.

Pharmaceutical Industry Donations & Continuing Medical Education
Pharmaceutical Industry Donations & Policy Think Tanks and Advocacy Groups
Pharmaceutical Industry Support for Patient Groups/Promotion of Prescription Drugs
Pharmaceutical Industry Donations & Charitable Conduits to Doctors
Pharmaceutical Industry Donations & Influencing Prescribing Guidelines

Pharmaceutical Industry Disclosure Practices