The Accreditation Council of Continuing Medical Education (ACCME), the main accrediting body for CME courses, responded to two reports dealing with transparency in physician-industry relationships. ACCME President and CEO Murray Kopelow, MD voiced his concerns with the Journal of the American Medical Association (JAMA) as well as the Pew Charitable Trusts' Pew Prescription Project.
As a background, on December 18, JAMA published a report seeking to explore the relationship between drug/device companies and "medical communication companies" (MCCs). Among the study's conclusions were that MCCs receive more funds than other types of CME providers and that they collect personal data from healthcare providers to share with third parties.
We pointed out several flaws with the study in our article on the report. Importantly, JAMA failed to differentiate between accredited medical education companies, which may not promote on behalf of pharma and "medical communication companies," which are not accredited and may. The report also disingenuously categorized charitable contributions of pharmaceutical companies as medical education payments, and identified two not-for-profit foundations as MCCs. Furthermore, JAMA criticized medical education companies' policy of sharing data, when JAMA's own policy includes sharing data with undisclosed third parties.
In addition to JAMA's inaccuracies, they failed to mention the rigorous accrediting process conducted by ACCME. Murray Kopelow explained ACCME's issues with the study in an interview with MeetingsNet.
"The article is wrong about ACCME-accredited providers from the beginning," he states. "There are no ACCME-accredited providers that are 'supported mainly by drug and device companies' and that 'develop prelaunch and branding campaigns." He continued: "Organizations involved in marketing or promotion are not even eligible for ACCME system accreditation. Thus, medical communication companies are not part of accredited CME in the ACCME system."
By merging medical communication companies and medical education companies in the article, Kopelow argues that JAMA presented a "misleading, inaccurate, and imbalanced picture of accredited continuing medical education and the stringent requirements in place to safeguard its independence." Kopelow described these safeguards ACCME in place to ensure that medical education companies are not providing promotional services to industry:
Before an organization can become accredited, it must meet the ACCME eligibility requirements. The organization cannot be involved in producing, marketing, distributing, or re-selling healthcare products or services used by, or on, patients. ACCME does a corporate review to ensure that the organization does not fall into the definition of commercial interest…
If there is a question as to whether a company is acting as a communication company, the ACCME does a corporate review to ensure that the organization does not fall into the definition of commercial interest. No organization that is accredited within the ACCME system can be owned or controlled by an ACCME-defined commercial interest.
The authors of the JAMA article imply that continuing medical education companies are funded almost entirely by industry. In fact, the majority of CME produced by medical education companies is not commercially supported. According to ACCME's annual report, only 18 percent of activities presented by ACCME-accredited providers received commercial support in 2012.
Kopelow also disagreed with the article's implications about a lack of transparency regarding this support: "Details of industry grants in the form of commercial support to all accredited providers have been available for review by the ACCME for decades. Every written agreement for every commercial support grant in all ACCME-accredited CME is available to the ACCME for review."
Kopelow made a number of other important points regarding the JAMA article, as well as CME transparency.
Is CME being "tainted by promotion"?
Kopelow believes "marketing masked as education," as the interviewer called it, is a concept that has been made obsolete by the ACCME's Standards for Commercial Support of CME, as well as the myriad of other government, professional, and industry laws, rules, regulations, and guidelines put into place over the last three decades. Accredited CME is based on professional practice gaps. It is designed without input from industry with respect to identification of need, determination of educational objectives, selection and presentation of content, selection of persons and organizations in a position to control the content, selection of educational methods, and the evaluation of the activity. The management of all funds is strictly regulated and all the terms and conditions of the commercial support are laid out in a written agreement. The ACCME Standards are recognized nationally, by the profession, by the regulators, and by the government as safeguarding the independence of CME.
While Kopelow acknowledges that pre-existing relationships that speakers and authors have with companies does present a threat to the independence of accredited CME, this problem was addressed in 2004 with the addition of the ACCME's Standards regarding the identification and resolution of conflict of interest. All those involved in the development and presentation of CME activities must disclose relevant financial relationships with commercial interests. Accredited CME providers must implement strategies for identifying and resolving any conflicts of interest that are identified through this process.
In the ACCME's opinion, JAMA also glazed over the most important aspect of CME: the actual content. 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. All scientific research referred to, reported, or used in CME in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, and analysis. Providers are not eligible for ACCME accreditation or reaccreditation if they present activities that promote recommendations, treatment, or manners of practicing medicine that are not within the definition of CME, or known to have risks or dangers that outweigh the benefits or known to be ineffective in the treatment of patients. An organization whose program of CME is devoted to advocacy of unscientific modalities of diagnosis or therapy is not eligible to apply for ACCME accreditation.
Is the Sunshine Act's CME exemption a loophole to allow industry to influence CME content?
Kopelow states, "[t]here is no back door allowing industry to influence the content of accredited CME." The CME exemption in Open Payments is not an exemption from ACCME, but rather "recognition that the commercial support of accredited CME does not establish a relationship with authors or speakers. It also shows that the government recognizes the value of the Standards for Commercial Support: Standards to Ensure Independence in CME Activities in safeguarding the independence of accredited CME."
While there are in fact loopholes allowing medical communication companies to bypass ACCME's policies, these companies are not accredited. "All accredited providers in the ACCME system, including the publishing and education companies, are held to the same high standards," and "under [ACCME's] rules, industry can provide no input whatsoever regarding content or speakers for accredited CME activities."
JAMA's editorial implies that industry regularly pays for physicians to fly to Maui for CME trips. Is this allowable?
"Under ACCME rules, industry is not allowed to make direct payment to physician learners or speakers with respect to an accredited CME event. Providers cannot use commercial support to pay the personal expenses of learners or their family for any reason whatsoever. Commercial support may be used to pay for faculty travel and expenses—but again, payments cannot be made directly from industry to physicians."
In addition to JAMA's deceptive data, Kopelow took issue with their misrepresentation of the 2007 Senate Finance Committee Report. While JAMA used various out-of-context quotes to conclude that abuse continued to be rampant in 2013, the report concluded that pharma was in fact doing a better job complying with fraud and abuse laws back in 2007. Kopelow states that since 2007, improvement has been even greater: "the ACCME took the concerns of the Senate Finance Committee very seriously and in response we enhanced our monitoring efforts. We accelerated the accreditation enforcement process to ensure more timely and rigorous oversight, particularly of noncompliance issues related to independence."
Finally, Kopelow addressed JAMA's assumption that medical communication companies collect healthcare providers' personal information to share with third parties. Kopelow stated, again, that accredited medical education companies are not MCCs: "We can only speak to rules regarding accredited providers and we cannot comment on the practices of medical communication companies, as they are not accredited in our system. The ACCME has rules requiring accredited providers to track participation and to explain to participants if the information is going to be shared."
In mid-December, the Pew Charitable Trust issued a report that indicated the ACCME's "Standards for Commercial Support" were not sufficient to ensure transparency in physician/industry relationships or to manage conflicts of interest in academic medical centers. We stated that the Pew recommendations merely restate their longstanding condemnation of accredited CME: that any financial support from commercial interests—no matter how stringent the restrictions on its use—renders the curriculum irrevocably tainted.
ACCME President and CEO Murray Kopelow, MD again answered questions and defended the rigorous standards in place. Indeed, Kopelow calls the successful and widespread adoption and implementation of ACCME 2004 Standards for Commercial Support: Standards to Ensure Independence in CME Activities by the ACCME and the CME community "one of the great successes of medical education in the 21st century":
We believe the [Standards] are the only common set of educational standards shared by multiple professions, specifically medicine, pharmacy, nursing, optometry, dentistry, and physician assistants. They are a fundamental building block of nursing, medicine, and pharmacy's Joint AccreditationTM—which is the only interprofessional education accreditation system in the world…
The 2004 Standards were approved by each of the ACCME's seven member organizations, which represent the profession of medicine and include physician licensing and credentialing bodies.
The Standards have become a national model. The ACCME Standards have been recognized across the health professions. The Accreditation Council for Pharmacy Education has adopted the Standards. In addition, the fields of dentistry, family medicine, nursing, optometry, osteopathy, and physician assistants base their accreditation standards on the Standards.
The federal government recognizes the value of the ACCME Standards in safeguarding independence and the role of accredited CME in supporting public health. The FDA has leveraged the accredited CE system in support of the [Risk Evaluation and Management Strategies] REMS for Extended-Release and Long-Acting Opioid Analgesics. Under this REMS, the FDA is requiring opioid manufacturers to provide grants for CME. This is one example of how commercially supported CME can address a critical public health initiative. In addition, CMS recognized the value of the SCS in safeguarding independence when it exempted accredited CME from its rule regarding physician payments reporting.
The ACCME Standards are recognized nationally, by the profession, by the regulators, and by the government as safeguarding the independence of CME.
Kopelow also expressed disagreement over the accuracy of Pew's claims and the relevancy of Pew's data, which, as we noted in our article, come from 1988, 1992, and 2001 statistics:
[T]he Pew report says, "… central [CME] offices do not prevent companies from specifying the topic of the course or which academic department should receive the funds." Of course they prevent companies from specifying the topics. ACCME says, "There is no reason for the CME provider to request suggestions for speakers or topics from commercial interests—since it is unacceptable to act upon their suggestions. CME providers can receive commercial support from industry. CME providers cannot receive guidance, either nuanced or direct, on the content of the activity or on who should deliver that content."
Pew also says, "...studies suggest that industry funding of continuing medical education tends to bias topic choices and content in favor of the sponsors' products and therapeutic areas." Pew cites studies from 1988, 1992, and 2001. The first ACCME SCS were adopted in 1992. The current version was adopted in 2004. The ACCME commissioned a review of this literature in 2008 looking for the evidence in support of this Pew hypothesis. We could not find it. We do not think it is appropriate to infer that there is research evidence for Pew's opinions.
Pew's report recommends "[i]n general, continuing medical education should not be supported by industry." Where industry funding is "nonetheless being considered," however, Pew advises several additional safeguards beyond compliance with the ACCME, including:
Creating an undesignated, or blinded, pool of money contributed by multiple companies for the purpose of supporting an institution's CME program.
Requiring that commercially funded courses be supported by at least two companies and that no single company contribute more than 50 percent for a given program.
Requiring that physicians personally contribute some money toward industry-supported courses.
Requiring that industry-supported courses take place in non-resort locations.
Kopelow concluded: "we do not have plans for incorporating those recommendations into our requirements."
Placing unfounded doubts in the minds of physicians over disclosure policies, as the Pew and JAMA articles do, is counterproductive and creates concern and confusion relating to the application of valuable information. As recently as late December, the Food & Drug Administration (FDA) distributed a presentation entitled: FDA Role in Continuing Medical Education (CME), which determined that: "CME (is an) essential part of staying informed as a practitioner," and that "FDA has (an) emerging role in using CME as one component of our work to improve safe use of medical products."
Last month, the CME Coalition responded to the JAMA and Pew reports, calling them "inaccurate…and disingenuous" and "dangerous to America's health" respectively. The ACCME's response reinforces these criticisms. The authors in both articles unfortunately make no effort to elaborate on (1) the content of the CME programs they attack, (2) the FDA mandates that the sponsor control the content so that speakers do not talk about off-label use or non-evidence-based application of products, or (3) the rigors of complying with the ACCME.