Life Science Compliance Update

« Previous article | Home| Next article »

November 05, 2010

CME Crossroads: Regulation and Enforcement Addresses Potential Conflict of Interest

Traffic-Police-001 
As we noted earlier, Global Education Group published a report entitled “CME Crossroads: A Survey of Continuing Medical Education Analysis, Criticism, Research and Policy Proposals,” which looked at four recent trends in continuing medical education (CME). Our first analysis of the report discussed conflicts of interest and the confusion between certified CME and non-CME. We also looked at the first two trends in CME the report found: better outcomes in CME and focusing CME on adult learning and expertise. This article will discuss the third and fourth trends, and analyze the recommendations the Crossroads report made.

Trend 3: Heighten CME Regulation/Enforcement

There is no doubt that between the founding of ACCME in the 1980s through 2004, there were a number of un­healthy practices in need of reform, including but not limited to dialogues between CME funding organizations and accredited providers regarding faculty selection and content. Between 2005 and 2010, the authors found a number of papers calling for a more restrictive regulatory framework, resulting in what was to become a radical transformation of the way in which CME is managed.

However, most of the cases of unethical or illegal practices involved marketing programs, not CME. Problems of lack of disclosure at Emory University and Stanford were related to direct payments for marketing ser­vices or research from industry to physicians, not CME grants to accredited providers. Additionally, the authors found no OIG settlements identified that related specifically to certified CME developed between 2005 and 2010.

Consequently, part of the problem today is that some critics are talking about a CME system that they were part of a decade ago. There are no more gifts, vacations, golf outings, etc. Still, those opposed to industry grant support for CME such as the Josiah Macy, Jr. Foundation and members of Congress said that CME needs increased regulatory vigilance.

In 2007, Senate Finance Committee Chairman Max Baucus (D-MT) asked the ACCME to take additional regulatory steps, saying. In addition, the 2009 Institute of Medicine report on Conflict of Interest in Medical Education cited several articles questioning whether or not ACCME standards and guidelines were effective in managing some CME practices. It should be noted that the IOM references to support these claims were from 2001 and 2003, prior to a series of more stringent ACCME policies implemented between 2004 and 2009.

CME Enterprise Response to Trend 3: Heighten CME Regulation/Enforcement

The ACCME, accredited providers, planners, faculty, and others actively responded to calls for change related to CME regulation and enforcement in a transparent rulemaking process. CME stakeholders updated policies, implemented new practices, and restructured their organizations to ensure that certified CME was managed by organizations and individuals independent of promotional influence. The ACCME produced a series of policy updates, new definitions, proposals, and standards that went into effect between 2005 and 2010.

In testimony to the U.S. Senate, the ACCME stated that it was “willing to add additional layers of monitoring, surveillance, and support to the systems it oversees.” The AMA introduced new CME formats stressing performance in practice in 2005. During the same year, the ACCME re­quired providers to begin implementing and demonstrating compliance with updated Standards for Commercial Support. As a result of this requirement, the ACCME produced several guides for the implementation of new rules, including those for “Identifying and Resolving Conflicts of Interest in Medical Education.” The following are quality improvement indicators related to Trend 3:

  • 2005 Implementation of updated ACCME Standards for Commercial Support requiring
    • Independence,
    • Resolution of Conflicts of Interest,
    • Appropriate Use of Commercial Support Grant Funding,
    • Appropriate Management,
    • Development of Content and For­mat without Commercial Bias, and
    • Disclosures to ensure transparency
    • 2006 ACCME Accreditation Criteria 1 through 22 (setting forth requirements to ensure edu­cational rigor and independence)
    • 2006 ACCME Elements addressing appropriate educational Purpose/Mission, Planning, and Evaluation/Improvement
    • 2007 updated definition of “commercial interest” requiring all accredited CME providers to sever any relationships to pharmaceutical and medical device marketing/promotion
    • 2008 and 2009 policy updates and calls for comment to ensure CME’s independence from promotional influences
    • 2009 ACCME statement to the IOM referencing ACCME Content Valida­tion Value Statements requiring CME content to:
      •  include evidence-based clinical recom­mendations,
      • rely on research that conforms to generally accepted standards of experimental design, data collection and analysis, and
      • meet the definition of CME and avoid patient care recommendations in which risks outweigh the benefits
      • Ongoing ACCME audits of accredited education providers to ensure they fully comply with all criteria and policies
      • 2009 ACCME rapid response measures to identify compliance infractions, place accredited providers on probation, and work with these organizations to bring them back into compli­ance
      • 2010 and future ACCME on-site audits of CME activities and Program Activity Reporting System

Trend 4: Address Conflicts of Interest

The authors noted that the most cited and debated issue regarding certified CME between 2005 and 2010 is that of “conflicts of interest.” Some of the materials the Crossroads Report reviewed claimed that accredited providers of CME did not comply with the requirement to “identify and resolve all conflicts of interest prior to education activities.”

Several articles and policy recommendations called for managing “both real and perceived conflict of interests.” Other articles reference conflicts by analyzing the intersection of “commercial and professional interests.”

The IOM defined conflict of interest as “a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest.” Virtually all the conflicts discussed in the literature fell within the IOM definition of conflict of interest, and most focused on financial conflicts or connections between industry and physicians. That is, a physician has a financial relationship with industry that creates a risk of undue influence.

The Crossroad reports makes an important finding by noting that most reports “comingle discussion of conflicts under a broad category of “educa­tion,” which often includes certified CME activities under the same umbrella as promotional pro­grams that are directly funded by industry.” This is problematic because there is a huge distinction between activities that are directly funded by indus­try for promotional purposes and certified CME activities.

Yet the consensus in the literature is that all financial relationships between industry and physicians create a potential for conflict of interest. The confusion appears to occur when authors and edi­torialists consider all forms of so-called “education” as certified CME.

When CME was specifically addressed and analyzed related to conflicts of interest, the authors categorized the literature within four conflict-related sub-topics.

Conflicts differ among accredited providers

The authors noted that several papers indicated that conflicts could be traced to a particular type of provider, despite a common set of accreditation criteria and rules for managing certified CME. Very few reports or testimony note the fact that all accredited providers – hospitals, schools of medicine, publishing/education companies, and physician membership organizations – must demonstrate compliance with the same rules for independence and appropriate management or risk losing their accreditation.

Eliminate Conflicts/Bias by Eliminating Industry Grants to Support CME

A group of reports recommends the elimination of industry grants to accredited CME providers. Others do not cite evidence but conclude that certified CME “may promote sales of new medica­tions” or that there “may be overlap between the material presented at promotional events…and CME courses.” Some articles noted the need to eliminate industry influence, not funding. Several organizations and individuals promoted proposals for physicians pay directly for all of their CME, similar to continuing legal education. However, even groups that promote the idea of physician-funded CME, such as the IOM, conclude that the proposal may not work as planned.

The Crossroads report made a significant comparison between CLE and CME, which many authors did not address. The authors noted that using this analogy between lawyers and physicians may be based on misperception, and actually could be harmful to public health. It should be noted that physicians, through their membership dues and registration fees paid to attend medical society meetings, already do help to underwrite the cost of a significant number of CME programs. Three of the major differences are:

Volume of information: More than 400,000 medical journal articles are published each year, making the practice of medicine much more dynamic than that of law. The sheer volume of new scientific data and changes in medicine requires as many appropriate avenues for funding certified CME as possible.

Changes to practice: The nature of medicine involves constant advancement, testing, and application. Medicine features landmark breakthroughs, such as the discovery and testing of a new therapeutic agent. The legal system is based on the tradition of stare decisis, or precedent. In short, changes in the law are evolutionary while changes in medicine often are revolutionary.

Mistakes make a difference: Continuing professional education is a must for physicians, partially because a drug used incorrectly is a poison. When a lawyer makes a mistake in practice, parties can appeal to a higher court. A physician mistake with prescriptions or on the operating table can mean serious illness or even death, a situation for which no appeal process exists.

Address Possible Bias in Certified CME

Several reports debate or attempt to define the meaning of bias. These proposals and critiques make the argument that industry funding of certified CME grants leads to bias in the educational activities. Many of these claims draw from psychological studies from 1986 and 1988 indicating that bias can enter into a discussion or educational presentation sometimes unnoticed. However, the specific 2008 Cervero and He survey concluded “there is no evidence to support or refute” speculation that commercial support produces bias in CME activities. Recently however, three studies produced this year showed substantial data that demonstrate a lack of commercial bias in industry-sponsored CME (Cleveland Clinic; Medscape, and UCSF).

Conclusions in the Absence of Evidence

The authors of the Crossroads Report found that “the practice of making strong claims regarding alleged CME problems without providing evidence to support the accusations was widespread in the literature.” In fact, they asserted that “In addition to making specific accusations without evidence, several articles make inferences about certified CME without cit­ing evidence. These authors often utilize statements incorporating the words “may” or “might” or “growing concern.” To the authors, discovering multiple examples of accusations without evidence was somewhat unexpected in an enterprise that otherwise strongly promotes development of “evidence-based” CME and a reliance on principles of “sound science.”

CME Enterprise Response to Trend 4: Address Conflicts of Interest

In reviewing the COI literature, the authors noted that many of the articles did not acknowledge the fact that the CME enterprise has policies to assess and address COIs prior to allowing a healthcare professional to work on a particular project. Conflicts of interest are inherent in any profession, especially one as large as medicine. While the risks that conflicts create will never cease, the CME enterprise responded to the risks with new practices, rules, and evidence demonstrating significant improve­ments and high ratings from the profession regarding CME quality.

The Crossroads Report does recommend that accredited CME providers now must manage a system for detecting, disclosing, and addressing conflicts of interest. In addition, these providers also must monitor for perceived bias. This examination and management prior to and following a CME ac­tivity requires accredited CME providers to actively manage CME content during its development and survey the physician audience members regarding any possible bias during the presentation of the certified CME content.

The Crossroads Report also notes that presently, all accredited providers now work in the CME planning and implementation phases to identify and manage conflicts. In addition, CME activities include surveys addressing potential bias of the CME faculty and content. The following are quality improvement indicators related to Trend 4:

  • National Faculty Education Initiative to train CME faculty on the difference between certified CME content and presentations and promotional/other content
  • Comprehensive bias study of more than a million physician CME participants
  • Comprehensive hospital network bias study > 95,000 physician CME partici­pants
  • ACCME requirement to both identify (via financial disclosures for all faculty and CME con­tent developers) conflicts and resolve them through mechanisms including elimination of the faculty member, altering the conflicted faculty member’s role, etc.
  • Monitoring and enforcement of Standards for Commercial Support for CME independence from promotional influence
  • The development of separate CME/IME departments within commercial interest organiza­tions, ensuring CME is managed outside of sales/marketing departments
  • ACCME rules prohibiting control over faculty selection and CME content by potential/cur­rent funding organizations, ensuring independence of accredited providers that develop certi­fied CME
  • Dramatic increases in the number of accredited CME providers on probation or working with the ACCME on progress reports for quality improvement
  • Increased transparency of ACCME reporting on accredited provider compliance
  • Increased transparency among pharmaceutical and medical device companies regarding CME grants issued

Recommendations

The Crossroads report recommends that the CME enterprise must be able to self-correct problems from the past to restore public perception by showing a willingness to adapt and improve. This includes a continued commitment to transparency and full disclosure, which can restore confidence in the quality of educational activities. There is also a need to have strong leaders who take responsibility for mistakes to reduce negative perceptions and restore faith in the efficacy of CME industry guidelines without additional government regulation.

Over the next five years, the report recommended that the CME enterprise must widen the national discussion about the importance of CME. Since the CME enterprise is made up of patients, physicians, faculty, accredited CME providers and many other stakeholders, the authors noted the need to embrace the calls for continued improvement and convene transparent, honest discussions about where CME has been, our progress, and our plan for the future. These individual voices, representing all stakeholder groups, then need to be harnessed into a national discussion that identifies areas for growth, improvement, and col­laboration ahead.

The authors also noted that since the CME enterprise expects CME to advance science and adhere to “generally accepted standards of experi­mental design, data collection, and analysis,” that CME analysis, criticism, and policy proposals should meet the same standard. They assert that “articles or papers without supporting evidence should continue to be publicly rejected,” and recognized that “in the absence of evidence, claims about the CME enterprise are at best a distrac­tion and at worst a turn in the wrong direction.”

ACCME Chief Executive Murray Kopelow, MD, appropriately summed up the path the CME enterprise has taken: “We’re in a different regulatory and operational environment now. It’s clear where the boundaries are. The commercial supporters see them and are respectful of them. The providers see them and know how to manage them. We need this to play out over some years, and ACCME needs to pro­duce data on compliance, and we’re going to.”

Conclusion

In the end, the authors recognize that “today’s CME professionals have the experience, expertise, and long-term commitment to manage the challenges posed by an increasingly complex healthcare environment.” Additionally, many stakeholders that comprise the CME enterprise have taken significant steps toward quality improvement.

Accordingly, instead of confusing definitions and making misguided claims or inappropriate regulations, the authors assert that the CME enterprise must better manage the success and quality improvement of certified CME by engaging in meaningful debate from within while educating the periphery (those not aware of the policies and practices of the CME enterprise).

The Crossroads report acknowledged that the CME enterprise needs to communicate clearly to groups outside of our industry exactly what the CME enterprise is, and perhaps more important, what it is not. They noted that, as “managers of CME, our movement toward quality will continue to improve healthcare through physician per­formance improvement. Genuine fidelity to that vision will ultimately lead to improved patient care, the goal of certified CME.”

« Previous article | Home| Next article »

TrackBack

TrackBack URL for this entry:
http://www.typepad.com/services/trackback/6a00e5520572bb88340133f5989976970b

Listed below are links to weblogs that reference CME Crossroads: Regulation and Enforcement Addresses Potential Conflict of Interest:

Comments

Feed You can follow this conversation by subscribing to the comment feed for this post.

The comments to this entry are closed.

Newsletter


Preview | Powered by FeedBlitz

Search


 
Sponsors
February 2018
Sun Mon Tue Wed Thu Fri Sat
1 2 3
4 5 6 7 8 9 10
11 12 13 14 15 16 17
18 19 20 21 22 23 24
25 26 27 28