Throughout their careers, physicians must acquire new knowledge based on ongoing research and discovery to provide patients with the best diagnostic and treatment methods. To ensure that physicians continue this practice of lifelong learning, most states in the United States have mandatory continuing medical education (CME) requirements for physicians to obtain or maintain licensure. The Accreditation Council for Continuing Medical Education (ACCME) oversees CME activities and accredits the organizations that provide this learning to physicians.
The ACCME and Commercial Interests
The ACCME criteria restrict accredited CME providers to organizations that are independent of commercial interests and promote advances in health care, rather than those that have proprietary or commercial interests.1 Pharmaceutical and medical device companies may be commercial supporters of CME activities, but they are barred by the ACCME’s Standards for Commercial Support from influencing CME activities, including the educational needs assessment, objectives, content, selection of persons in control of the content, educational methodology, and evaluation. Despite these prohibitions, commercial spending on CME for physicians and other health care professionals reached a peak of $1.2 billion in 2007 before dropping to $659 million in 2013. Since then, spending has increased steadily to nearly $740 million in 2017, when commercial support accounted for 28% of all CME funding.2
To prevent undue influence by commercial interests, commercial funding from pharmaceutical and medical device companies for CME events is granted to ACCME-accredited organizations (e.g., medical education companies, academic organizations, health and hospital systems, physician member organizations) that then apply that support to offset their CME activity costs. Working through accredited CME providers ensures that the content reaching health care professionals is unbiased and that any conflicts of interest due to the event planners’ or speakers’ relevant financial relationships with commercial interests have been successfully resolved.
The ACCME rules prohibiting the accreditation of “commercial interest[s]” state that commercial interests “cannot be accredited providers and cannot be joint providers.”3 The ACCME defines a “commercial interest” as “any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.”3 According to ACCME President Graham McMahon, the “guiding principle behind the definition is that [the ACCME rules are meant to] prohibit organizations that might use CME to market products or services they produce to doctors who then would prescribe or use those products or services on patients inappropriately.”4
The Effects of Commercially Funded CME on Physicians’ Behaviors
There is concerning evidence that completing a pharmaceutical company-supported CME activity, even when the event is run by an ACCME-accredited provider, alters physicians’ prescribing behaviors, which might not be in the best interest of patients, payers, and society.5 Commercial support for CME events affects presentation content,6 with the drug of the company supporting the event often being preferentially highlighted.7 Similar to direct interactions between physicians and pharmaceutical sales representatives, which have been shown to alter prescribing and formulary requests,8 commercially supported CME events lead to physicians increasing their prescribing of the drugs produced by the companies supporting the events more than their prescribing of other drugs in the same class.7 Physicians who accepted commercial funding to attend symposia were more likely to generate more formulary addition requests for the drugs produced by the companies funding the symposia.9 According to a 2001 article, most residents reported that pharmaceutical companies’ marketing efforts did not influence their prescribing, but only 16% believed the same of their peers.10 Physicians receiving compensation from medical device manufacturers frequently did not disclose this information when publishing on related topics.11
With mounting public concern about physician–industry relationships,12,13 the ACCME in 2007 redefined “commercial interest[s]” to include companies involved in “marketing” health care goods or services consumed by, or used on, patients.3 They also created a structured self-assessment so companies could determine if they were commercial interests under the new definition.14
The U.S. Senate Finance Committee’s 2007 report “Use of Educational Grants by Pharmaceutical Manufacturers” had a significant impact on commercial funding for CME activities, with pharmaceutical companies assiduously separating their grant-making processes and departments from their marketing divisions.15 Updates to the ACCME accreditation criteria in 2006 and 2016 were associated with decreases in perceptions of bias in commercially supported CME activities.16,17
Electronic Health Record Vendors as Commercial Interests
While focusing on preventing pharmaceutical and medical device companies from becoming CME providers, the ACCME has accredited other commercial entities that produce and market products and services that could be used inappropriately on patients. These entities are electronic health record (EHR) vendors. The EHR industry is a $31.5 billion per year business,18 and the interaction of physicians and EHR vendors is highly consequential for physicians themselves, patients, payers, and society. The U.S. Department of Health and Human Services Office of the National Coordinator (ONC) for Health Information Technology reported that EHRs are used by 86% of office-based physicians and that 4 of every 5 clinics has adopted an ONC-certified EHR system.19
Even though the 21st Century Cures Act excluded EHR systems from the Food and Drug Administration’s (FDA’s) oversight, they should be considered medical devices similar to pacemakers, insulin pumps, and CT scanners, which are all under the purview of the FDA. No other commercial device or technology is used more often by physicians and other health care professionals than EHRs. In addition, EHR vendors meet the definition of a commercial interest, namely they are entities that produce, market, resell, or distribute health care goods or services that are consumed by, or used on, patients. Not only is the care of patients influenced by how EHRs are designed and implemented, but patients and their caregivers also interact with EHRs directly through patient portals.20 Therefore, there are compelling ethical reasons for EHR vendors to be considered commercial entities that are ineligible for ACCME accreditation.
The Need for Unbiased EHR Education
EHRs have led to novel unintended challenges as well as patient safety issues in clinical care.21–23 Although health information technology (IT) has the potential to improve patient safety, especially once the technology has matured,24,25 it also may jeopardize patient–physician communication26 and the safe provision of care and may lead to physician burnout.27–29 EHR vendors’ efforts to encourage the correct use of their products can counter these challenges. However, known publication bias for positive studies of EHRs30 and the “hold harmless” and nondisclosure clauses in vendor contracts, which prevent physicians from disclosing flaws in these systems,31,32 combined with marketing focused on improving vendors’ profits, can result in poor purchasing and upgrade decisions by physicians, which may adversely affect patients.
The use of EHRs and their embedded decision-support systems have led to ethical challenges related to the range of appropriate uses and users, skill degradation, and interoperability, which may further diminish the utility of vendor-specific education.33 Because of the inherent risk in using EHRs, as with recognized medical devices, the education of the physician workforce that implements and maintains these systems, including those in the new clinical informatics subspecialty,34,35 must be as sound, comprehensive, and free from influence by commercial interests as possible.
The Effects of EHR Vendor-Funded CME on Physicians’ Behaviors
EHR vendors with large market shares36 currently hold and sponsor multiday CME events. These events are attended by thousands of health care professionals and offer nicely furnished surroundings (frequently on vendor campuses) and gifts in the form of free food and drink, entertainment, and social programs that are designed to provide levity and amusement. From these vendors, attendees receive greatly discounted (or free) CME credits, which they need to maintain their license to practice medicine. Attendees also receive other gifts, which have been shown to alter their neuropsychological responses,37 generate reciprocity,38 and modify their behavior unbeknownst to them.39
To describe the potential effects of EHR vendor gifts, we replaced “drug companies” with “EHR vendors” in the following key quote from a seminal New England Journal of Medicine article:
The relationships between [EHR vendors] and doctors would be of little interest if they did not have potential consequences for patients, doctors, and the larger society. Explicitly or implicitly, much of the debate about these relationships revolves around the question of whether [EHR vendors] influence physicians’ behavior and, if they do, whether the results are, on balance, positive or negative for the quality and cost of health care and for the profession of medicine itself.12
Similar to pharmaceutical companies’ “expert” dinner meetings,40 which are now prohibited by the pharmaceutical industry’s own code of conduct41 and the federal Anti-Kickback Statute,42 EHR vendor-sponsored CME events focus exclusively on and highlight preferentially one EHR product and its benefits and by design do not discuss or even mention solutions or products by competitors. Because every EHR system has intrinsic limitations, attendees are not adequately trained on alternate ways to solve problems. Variations in EHR system functionalities and layouts can be a source of data bias.43 Vendors might tell the truth about their product, but they provide an incomplete version of the known knowledge in the field, which is another form of information bias. Instead of learning best clinical informatics practices44 and challenging the vendor to improve its product, attendees are presented with only the vendor’s worldview, which may result in their suboptimal or inappropriate use of EHR products or services on patients.
Former president and chief executive officer of the American Medical Informatics Association Douglas Fridsma explained:
To prevent harm to patients, clinicians need fundamental training in how to collect, analyse, and use health data—training that is not tied to a specific technology. Without that foundation, … we are faced with the educational equivalent of drug companies teaching medical students the mechanics of how to write a prescription for their products, without teaching them essential pathophysiology, pharmacology, and microbiology to make them safe and effective prescription writers. We need to move beyond the basic mechanics of how to use information technology and teach health providers the underlying science of health information.45
At the CME events they sponsor, EHR vendors only present solutions that are specific to their systems and, in theory, prevent attendees from considering associated products (analytics, messaging, interoperability, consumer interfaces, web portals, other integration activities, etc.). This may lead attendees to “anchor” in the EHR system of the event sponsor. Many EHR vendors are already known to provide very little corporate social responsibility information.46 They also like their customers to wait until they develop and introduce additional proprietary services and technologies to the market, rather than have clients adopt solutions from other companies that are already available. In addition, they divert customers’ attention from their competitors’ solutions, which might improve care immediately and might very well replace their product in the future. EHR vendors focus physicians’ attention on future enhancements to their systems so physicians may miss opportunities to implement available solutions that are more congruent with the needs of their patients, organizations, and the community.
In itself, EHR vendors educating and training physicians to better use their systems is not concerning. This kind of education could lead to better patient care. In fact, the ACCME has defined specific scenarios in which employees of ACCME-defined commercial interests are permitted to control the content of certified CME events, for example, a technician “teach[ing] the safe and proper use of medical devices.”47 However, education provided directly by an EHR vendor does not meet the stringent requirements for unbiased CME.
Is the accreditation of EHR vendors as CME providers a problem? We believe the answer is yes, because vendors focus their CME events solely on their own content and products rather than the full scope of the health IT available. Clinical informatics is a board-certified medical specialty, and the ACCME’s clinical content validation rules for all specialties demand that “all the recommendations involving clinical medicine in a CME activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients.”48 Omitting substantial portions of that evidence is not acceptable.
In addition, potential reciprocation or “quid pro quo” by attendees to the EHR vendors that sponsor a CME event is similar to the altered medication prescribing practices of attendees of pharmaceutical industry-sponsored events. As the purchase of health IT, such as an EHR system, is a large project involving many groups and individuals in a health care system, some have argued that no single attendee of a vendor-sponsored CME event alone can affect the purchasing of an EHR system or the subsequent care of patients. Unfortunately, this is not the whole story. First, EHR vendor-sponsored CME events may include tens or even hundreds of attendees from a single institution, thereby vendors do have the power to influence institutional decisions. Chief medical informatics officers49 and other physicians who attend vendor-sponsored CME events are in a position to make important purchasing and update/improvement decisions that ultimately affect patient care. The potential need for them to reciprocate for the gifts they receive from EHR vendors that are CME providers could prejudice their decisions to the detriment of patient care. Further, there is the risk that published evaluations of vendor products by these attendees may become more favorable or their conflicts (like receiving CME from the EHR vendor) may not be properly disclosed, as has been the case with attendees of medical device company-sponsored CME events.13
As with medical devices, EHR systems require “interaction between physicians and industry that is considerably more intimate than that in pharmaceutical development.”50 Though physician–industry partnerships can have desirable outcomes, they must be fully transparent and not overlook flaws that jeopardize patient care. The ideal patient–physician relationship places the best interests of patients over those of physicians, even as they pertain to health IT, which may not be possible if physicians are influenced by the vendors that sponsor their CME activities.51
Unmanaged conflicts of interest are most concerning during the purchase of an EHR system. Such purchases require large investments in products that will be used for decades. However, health IT is constantly changing, and systems are always in need of new features, modules, and modifications. EHR systems are upgraded, replaced, and modified, even while they are in use in patient care. Thus, physicians often have to make important decisions about vendor partners, products, consultants, and overall strategy that directly affect patients. They cannot get too close or become indebted to vendors. Patients need physicians to critically analyze EHR system modifications, demand improvements, and modify the deployment of health IT to meet their needs and to protect them from potentially poor or self-interested vendor decisions.
Unlike the airline industry, which is heavily regulated and tightly overseen by the Federal Aviation Administration, EHR vendors, whose systems contain the sensitive data of hundreds of millions of people, have limited government supervision, as the 21st Century Cures Act excluded EHR systems from the FDA’s oversight of medical devices.52 This leaves only limited product certification by nongovernmental, ONC-authorized testing and certification bodies.
Conclusions and Recommendations
We applaud the American Board of Preventive Medicine’s (ABPM’s) past practice of declining EHR vendors’ requests for Lifelong Learning and Self-Assessment (LLSA) credits for their sponsored CME events. This practice has led health care professionals to instead attend conferences offered by independent ACCME-accredited CME providers, such as the American Medical Informatics Association. At these events, optimal and differential clinical informatics solutions are presented and discussed without focusing on any specific EHR system or vendor. However, the ABPM’s recent combining of LLSA credits and CME credits into a single CME requirement for physicians board certified in clinical informatics53 poses the risk that a physician may now earn all her or his CME credits through one EHR vendor.
EHR vendor-provided CME events are potentially biased, and they pose a risk to patient care and safety. We call on the ACCME to recognize EHR vendors as commercial interests and to remove them from the list of eligible CME providers. EHR vendors that want to support unbiased CME events should follow the same process that was developed for other commercial interests, such as pharmaceutical and medical device manufacturers.
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