According to a recent article in Oncology Business Review, oncology patients will be hurt by the withdrawal of commercial support of CME. They also outline how the new rules have forced some medical education companies to give up their CME provider status. It is important to consider all the costs of regulations and that the industry has changed significantly in the last few years.
The oncologists interviewed were very candid in their comments in the effects of CME on Oncology.
If industry is cowed by all the attention, and pulls away from CME funding, the effect would be profound, says Jordan Berlin, M.D., Clinical Director of Oncology, at the Vanderbilt-Ingram Cancer Center. “There will be significant reductions in CME activities.”
For instance, we run two courses reviewing ASCO and ASH presentations and those will go away—that data is the newest information.” There will also be a shift to online content, which Berlin finds to be far less comprehensive and too demanding of a physician’s time. “And what happens when you can’t get knowledge from [our program] or other CME programs? People will turn to their drug rep.” And most feel this would not be a step in the direction of unbiased, patient centric information.
Another oncologist, Debu Tripathy, M.D., Director of the Komen/UT Southwestern Breast Cancer Research Program at the University of Texas, and a frequent faculty member of CME activities, considers Pfizer’s move to be a kneejerk reaction. “I think that was done for cosmetic reasons, because there’s a perception that for-profit companies may have bias, but the evidence actually speaks to the contrary.” According to him, the ACCME has for many years required all MECCs to keep track of the audience’s perception of bias; and most programs, he stated, score pretty high with “95% to 98% of attendees usually feeling that the information was fair balanced.”
The Accreditation Council for Continuing Medical Education (ACCME) reported in 2008 that continuing medical education (CME) providers had income of over $2.3 billion, with $1.0 billion of that sum coming from commercial support.
Although Senator Grassley (R-IA) of the Senate Finance Committee believes that CME funding largely comes from pharmaceutical manufacturers, the ACCME numbers prove him wrong: roughly one-half of the money that goes to CME is not directly from industry.
Interestingly, in August 2007ACCME set a deadline date of August 2009 for one of its most restrictive policies to date: Providers of CME cannot be owned directly by a commercial interest (a CME provider must be a distinct legal entity with offices separate from marketing). As a result, ACCME will start to hold accredited providers accountable to its revised definition of commercial interests, in which commercial interests cannot be accredited providers and cannot be joint sponsors of CME material.
Prior to this date, companies such as Pfizer announced that it would no longer provide funds or unrestricted educational grants, to medical education communication companies (MECCs) to produce CME materials. Instead, Pfizer decided to only provide unrestricted educational grants to non-profit entities such as academic institutions, teaching hospitals, and medical societies.
While in theory this seems to be a good idea, most non-profit entities and academic institutions still cannot afford to pay staff or physicians to support large educational programs based solely on these grants. This will lead to fewer CME courses, and sometimes a failure to even take on a course.
Karen Overstreet, President of Indicia Medical Communications, and a pharmacist by training, emphasized the problem perfectly: “It’s unfortunate that the misdeeds occurring when a different set of rules were in place keep bubbling up and getting a lot of attention.”
In other words, the labels are ex post facto: the laws that exist now cannot punish the past. Furthermore, “the majority of CME providers have updated their procedures, and are diligent in their compliance with existing guidelines, especially to those pertaining to fair balance or the promotion of off-label use.”
The Alliance for Continuing Medical Education (ACME) and the Society for Academic Continuing Medical Education (SACME) has launched the faculty education initiative to help physician educators and others to understand the differences between Certified CME and company-directed FDA regulated education.
The Alliance has developed a set of core competencies for CME professionals—skills and abilities needed in order to be effective and unbiased communicators. These include partnering techniques with fellow CME stakeholders; systems that recognize the complexity of the healthcare system; and organizational self assessment. “There’s a huge amount of confusion out there related to CME,” says Balmer, “and the more we are all on the same page, the better we can communicate with the regulators.”
As far as the August 2009 deadline, Balmer reports that there’s been no mass exodus from the CME world as yet, and the main complaint to date is the effort and expense it takes to actually fill out all the necessary forms
Any negative impact on CME funding will result in worse patient care, which is contrary to the new ACCME guidelines. Instead of restricting funding, guidelines need to focus more on reporting, and making certain that companies and physicians do so properly.
At the annual ACME meeting, one participant noted that “there’s a huge amount of confusion out there related to CME, and the more we are all on the same page, the better we can communicate with the regulators.” Rather than trying to eliminate this confusion by prohibiting funding, the reasonable approach is to find ways to encourage a uniform system for industry to provide funds in order to reduce any signs of conflict.
While the main complaint of these new guidelines will be the paperwork it creates, “CME isn’t going away, it is changing, and the companies that provide CME are changing too, making the process harder for providers, grant writers, and sponsors.”
Consequently, funding should be making the process easier for providers and grant writers, because they will be able to extrapolate new theories and ideas that are not restricted by monetary measures. Hence, if freedom of enterprise and innovation in medicine and technology are to last much longer in America, industry and CME need guidelines that support their teamwork and not work against it.