An article and accompanying editorial in the December 18 edition of the Journal of the American Medical Association explored the relationship between “medical communication companies” and drug and device companies—and drew some conclusions that caused many in continuing medical education to cry “foul.”
“Medical Communication Companies and Industry Grants,” by Sheila M. Rothman; Karen F. Brudney, MD; Whitney Adair; and David J. Rothman, PhD; all affiliated with Columbia University, was based on an analysis of 2010 data from 14 pharma and device companies. Among the study’s conclusions were that “medical communication companies” receive more funds than other types of CME providers and that they collect personal data from healthcare providers to share with third parties. The editorial, “Medical Communication Companies and Continuing Medical Education: Clouding the Sunshine,” by Lisa M. Schwartz, MD, MS, and Steven Woloshin, MD, MS, both with the Center for Medicine and the Media, Dartmouth Institute for Health Policy and Clnical Practice, similarly concludes that CME is tainted by association with promotional activities and that MCCs are collecting HCP data to use for pharmaceutical and device company promotional purposes.
The problem, says Andrew Rosenberg, senior advisor with CME advocacy group the CME Coalition, is that “there are so many inaccuracies and examples of unfounded innuendo contained in both the ‘report’ and the editorial, it is a challenge to enumerate them all.” Among the errors he cites are a failure to differentiate between accredited medical education companies that provide CME activities, and medical communication companies, which are not accredited to provide CME, but which do provide communications and promotional services to pharma and device companies.
The Association of Clinical Researchers and Educators also points out flaws in the study, such as “inclusion of foundation funds and nonprofit giving in the aggregate,” identifying two not-for-profit foundations as MCCs, and disparaging the medical education companies’ policy of sharing data with third parties as unique, when in fact JAMA’s own policy includes sharing data with undisclosed third parties.
MeetingsNet: Under ACCME’s current accreditation requirements, what role, if any, do medical communication companies play in accredited CME? What role do medical education companies play? What is the difference between the two?
Kopelow: The article is wrong about ACCME-accredited providers from the beginning. There are no ACCME-accredited providers that are “supported mainly by drug and device companies” and that “develop prelaunch and branding campaigns.” (I believe this is how the authors define a medical communications company) It is contrary to ACCME regulations for accredited providers to involve themselves in promotion or marketing for industry—for example, to develop prelaunch and branding campaigns. 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.
On the other hand, there are over 150 publishing/education companies accredited within the ACCME system, operating in compliance with ACCME requirements.
By conflating medical communication companies and medical education companies, the article presents a misleading, inaccurate, and imbalanced picture of accredited continuing medical education and the stringent requirements in place to safeguard its independence.
MeetingsNet: What safeguards does ACCME have in place to ensure that medical education companies are not in fact acting as communication companies or otherwise providing promotional services to industry?
Kopelow: We screen to prevent such organizations from becoming accredited and we provide surveillance through the accreditation process to ensure they do not begin to provide such services. Before an organization can become accredited, it must meet the ACCME eligibility requirements. It cannot be involved in producing, marketing, distributing, or re-selling healthcare products or services used by, or on, patients. This definition means that medical communication companies cannot become accredited providers or serve as joint sponsors.
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. No ACCME-accredited provider has a parent company that produces, markets, distributes, or re-sells healthcare products or services used by, or on, patients.
MeetingsNet: Are there any points of comparison you'd like to make with ACCME's most recent data report?
Kopelow: The publishing and education companies make an important contribution to the continuing medical education enterprise of the United States. Their presence, their role, and their importance should not be denigrated or underestimated. In 2012, the publishing and education companies provided 22,000 accredited activities (17 percent of the total of 133,000 activities), comprising 70,000 hours of accredited CME (7 percent of the total of 988,000 hours). These activities drew 4.3 million physicians (30 percent of the total of 14 million physician participants) and 4.3 million nonphysician participants (43 percent of the total of 10.2 million nonphysician participants). The absence of publishing and education companies from the family of ACCME-accredited providers would have a profound and negative impact on healthcare professionals’ access to unbiased, independent, practice-based accredited CME. This access is critical to healthcare improvement, as accredited CME is designed to change learners’ competence or performance or patient outcomes.
According to our 2012 data, publishing/education companies did receive more commercial support than other provider types. However, the recent JAMA article states that that medical communication companies are “mainly supported mainly by drug and device companies.”
The ACCME’s published annual report data does not support this claim [for medical education companies]. Medical education companies accredited by the ACCME do not receive most of their income from commercial support. In 2012, publishing/education companies (as they are categorized in our data) received an average percentage of 38 percent of their total income from commercial support. The majority of CME produced by medical education companies is not commercially supported. An average of 35 percent of their activities received commercial support. This information is shown in Figure 3.6 of the ACCME’s 2012 annual report, page 34. Figure 3.6 also allows for comparisons with the other provider types.
MeetingsNet: What about the finding that "medical communication companies," as defined in the article, received more funds than academic medical centers, societies, and research organizations in the authors' 2010 data pull?
Kopelow: As I said, no communication companies are accredited by the ACCME system. We do not find the commercial support received by publishing/education companies worrisome because all accredited providers are held to the same high standards regarding educational quality and independence. All accredited providers go through the same rigorous reaccreditation process. Our compliance data shows that publishing/education companies perform as well as other provider types in terms of complying with the accreditation requirements for independence. We regularly review and analyze compliance data and we have never found any compliance concerns related to provider type.
Further, the article implies there has been a lack of transparency about commercial support provided to medical education companies. We have produced annual reports since 1998, which include aggregate numbers for the commercial support received by accredited providers, by provider type. These reports are published on our Web site and enable the public to see how much commercial support accredited medical education companies and other accredited providers have received each year.
The article also says, “Industry…are not publicly available and until recently neither were industry grant awards.” 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. We review all the agreements from a random sample of commercially supported CME for every accredited provider. The ACCME expects every letter of agreement for each commercial support grant to be appropriately executed and on file for each commercially supported activity.
MeetingsNet: Would you explain why the ACCME has historically rejected the call to eliminate commercial support for accredited CME?
Kopelow: The ACCME member organizations, which represent the profession of medicine and include physician licensing and credentialing bodies, and the CME community overwhelmingly rejected the ACCME’s 2008 call for comment about the elimination of commercial support as unnecessary and potentially damaging to U.S. healthcare education. The majority of stakeholders deferred to the power and sensitivity of the ACCME’s Standards for Commercial Support of CME as appropriate educational safeguards. Since then the healthcare continuing education accrediting bodies of family medicine, osteopathy, optometry, dentistry, pharmacy, nursing, and the physician assistants have based their systems on these same Standards.
It is also important to put commercial support in perspective. Only 18 percent of activities presented by ACCME-accredited providers received commercial support in 2012, according to our annual report. Eighty-two percent of activities did not receive commercial support, accounting for 81 percent of physician participants and 78 percent of nonphysician participants.
MeetingsNet: The editorial says that the only way to keep CME from being “tainted by promotion” so that it is “marketing masked as education” is to eliminate commercial support altogether and provide “routine, independent vetting” of individual activities.
Kopelow: I do not believe that there is any mechanism for commercially supported ACCME-compliant accredited CME to become “tainted by promotion” or to be “marketing masked as education.” These are concepts 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.
Of primary importance are the ACCME’s rules. Accredited CME is always 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.
The pre-existing relationships that speakers and authors have with companies does present a threat to the independence of accredited CME—but this 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 addition, the content must be valid. 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.
The ACCME does vet individual activities. During each provider’s reaccreditation process, the ACCME selects up to 15 activities for review. These activities are reviewed by trained,surveyors, ACCME staff, and the Accreditation Review Committee. This activity review, along with the accredited provider’s self-study report and interview, is an integral part of the reaccreditation process. The ACCME has a rigorous, multilevel process for making accreditation and reaccreditation decisions. In addition, the complaints process allows CME learners or anyone else who has concerns about an accredited provider’s compliance to submit a complaint to the ACCME.
MeetingsNet: The editorial also marks the CME exemption from Sunshine Act transfer-of-value tracking and reporting requirements as a back-door way to allow industry to influence CME content. Keeping in mind ACCME accreditation requirements and the Standards for Commercial Support, is this likely and/or possible if the CME provider were an ACCME-accredited MEC?
Kopelow: There is no back door allowing industry to influence the content of accredited CME and frankly we do not understand why someone would say that. The CME exemption in the Open Payments program is not an exemption from ACCME’s requirements. It is 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. What possible association could there be between this exemption and industry influencing content?
MeetingsNet: Are there in fact “loopholes that allow medical communication companies to bypass some of [ACCME and individual organizational] policies”?
Kopelow: Yes—because, as I have said, these companies are not accredited. Education that bypasses ACCME-accredited providers has not demonstrated that it meets the profession’s standards for independence, freedom from commercial bias, content validity, or the identification and resolution of personal conflict of interest. All nonaccredited CME and all education emanating from promotional and communication companies circumvents the ACCME requirements and system of accountability. As we stated earlier, all accredited providers in the ACCME system, including the publishing and education companies, are held to the same high standards.
The accreditation decision-making process includes evaluation of the organization’s compliance with the Standards for Commercial Support and related policies. Under our rules, industry can provide no input whatsoever regarding content or speakers for accredited CME activities.
MeetingsNet: The editorial implies that industry regularly pays for physicians to fly to Maui for CME activities. Is this allowable under ACCME rules? Are there other rules that also may prohibit this type of transfer of value for U.S. physicians?
Kopelow: Again, we are not accountable for nonaccredited education. Under ACCME rules, industry is not allowed to make direct payments 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 fortravel and expenses—but again, payments cannot be made directly from industry to physicians.
MeetingsNet: The article cites the rationale behind the 2007 Senate Finance Committee Report, but not its conclusion that pharma is in fact doing a better job of complying with fraud and abuse laws than it once did. Is this an important omission for those interested in where this issue currently stands?
Kopelow: Yes, this is an important omission. The concerns of the Senate Finance Committee staff were that commercially supported CME could contribute to the overuse of products. Overuse is still a potential undesirable outcome, which is why we continue to enforce our Standards. 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. We added four- and eight-month progress reports to our process to create more of a “rapid cycle improvement process” for providers that are found out of compliance with the Standards for Commercial Support. Previously, providers were given 12 or 18 months to submit reports. We also increased the support and monitoring of providers that receive probation and are on the path to nonaccreditation. For example, the ACCME CEO now speaks directly to the CEO of each accredited provider put on probation. Virtually all of these providers implement improvements quickly, leading to sustained compliance. The few that do not demonstrate improvement go to a nonaccreditation status.
MeetingsNet: Do you have any comment on the articles’ assumption that “medical communication companies” are collecting healthcare providers’ personal information to share with third parties for promotional reasons? Could there be other reasons they collect individual information such as the learner’s graduation date, specialty, training level, National Provider Identifier numbers, and pre- and post-activity assessments?
Kopelow: 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.
ACCME policy states, “The accredited provider must have, adhere to, and inform the learner about its policy on privacy and confidentiality that relates to the CME activities it provides on the Internet.” Any assumption that learners are not informed on these matters implies that providers are not in compliance with the ACCCME’s requirements. Perhaps the study’s investigators were not aware of this ACCME policy.
ACCME policy also states, “An accredited provider must have mechanisms in place to record and, when authorized by the participating physician, verify participation for six years from the date of the CME activity.”
As for the reasons accredited providers may collect individual information from learners, one example is if the accredited provider is developing-compliant CE under the Extended-Release and Long-Acting Opioid Analgesics REMS, as stipulated by the Food and Drug Administration (FDA). In this case, the providers have volunteered to collect and report data for the FDA about accredited CE activities including learners’ professions, specialties, and practice types. This example demonstrates how data collection by accredited providers can support public health initiatives.