CEJA Releases New Report on Industry Relationships with CME

The American Medical Association's Council on Ethical and Judicial Affairs has released a new report, 1-A-09 Financial Relationships with Industry in Continuing Medical Education, to be introduced at the AMA's Annual House of Delegates meeting in June. The report can be accessed on the AMA's website here.

The report differs dramatically from the one issued last year, most notably by eliminating the recommendation to ban industry support of CME completely. Instead, this report makes a distinction between what is ethically preferable, permissible and prohibited.

It is ethically preferable that:

"CME providers accept funding only form sources that have no direct finacncial interest in a physician's clinical recommendations and that that those involved in CME have no current, recent or potential direct financial interest in the subject matter and are not currently/have not recently been involved in a compensated relationship with a commercial interest in the educational subject matter."

However, the council recognizes "... that this ethical ideal cannot feasibly be implemented for all professional education". In certain situations, interaction with persons or organizations with a conflict can be ethically permissible. These situations include:

1. CME providers accept funding from industry sources if the following conditions are met:
   a. the educational activity is planned by the provider based on needs identified independent of and prior to solicitation or acceptance of the funding; and
   b. the use of the funding is not restricted in any way; and
   c. the source of the funding is clearly disclosed; and
   d. the CME provider is not overly reliant on funding from industry sources.
2. CME providers permit individuals who have modest financial interests in the educational subject matter to program, develop content for, or teach in CME activities if the following conditions are met:
   a. the existence and magnitude of any financial interests are clearly disclosed; and
   b. steps are taken to eliminate or mitigate the potential influence of those interests.
3. CME providers permit an individual who currently has a direct, substantial, and unavoidable financial interest in the educational subject matter (e.g., as the inventor of a new device) to program, develop content for, or teach in a CME activity only if the following conditions are met:
   a. the individual is demonstrably uniquely qualified as an expert in the relevant body of knowledge or skills; and
   b. participants are clearly informed about the nature and magnitude of the individual’s specific financial interest in the subject matter; and
   c. there is a demonstrated, compelling need for the specific CME activity in the professional community that cannot otherwise be met; and
   d. steps are taken to mitigate the potential influence of the unavoidable financial interest to the greatest extent possible; and
   e. every effort is made to develop a pool of qualified, independent experts as quickly as possible.
   

If none of these conditions are met the financial relationship would be deemed ethically prohibited.

It is clear that great time and effort was put into this report (Over 35 references, plus a supplemental report) and the council did take the concerns of stakeholders into consideration.

What do you think about the report? On target? Too restrictive? Make comments, below!

Diversity Mélange in Healthcare: Cultural & Linguistic Competency in Continuing Medical Education

By Yumi Aikawa, MPH, Institute for Medical Quality, San Francisco, CA

The need for Cultural & Linguistic Competency (CLC) in healthcare begins with a concern about how to prevent, reduce, and eliminate disparities in health and the healthcare system as a whole. There are a growing number of studies that document that the patient-provider relationships influence quality of care, and consequently, patient health outcome. Thus the goal of incorporating CLC topics into CME is to provide opportunities for healthcare professionals to strengthen their understanding of and communication with patients in ways that impact care delivery and health outcomes for all patients. The idea of identifying physicians’ performance and competence gaps as a means to address underlying deficits in the quality of care has been one of the key evolutionary points of the CME paradigm, and it is the fundamental motivation behind the movement to incorporate CLC into CME.

A few pioneering states including California has a bill that mandates all CME activities provided within the state to include CLC components. In the California healthcare system, CLC is interpreted as “a set of integrated attitudes, knowledge, and skills that enables a health care professional or organization to care effectively for patients from diverse cultures, groups, and communities.*”

The terms “attitude, knowledge, and skills” include such practical components as: 1) linguistic accommodations, 2) information to establish therapeutic relationships, and 3) cultural and ethnicity data in diagnosis, treatment, and overall process of clinical care. Likewise, “cultures, groups, and communities” can also be based on a wide range of ideas and characteristics including (but are not limited to): 1) religion/faith/spirituality, 2) nationality, 3) race/ethnicity, 4) sexuality, 5) gender roles/identities/presentations, 6) age, and 7) geographical associations.

The important point about culture that must be acknowledged when planning CME activity is that “culture” in this context includes dimensions beyond commonly used demographic categories. Culture must be approached as a dynamic concept that is not mutually exclusive, each component inter-related in a non-linear fashion. This is because often those who are affected the most by disparities identify with multiple cultural identities. Culture also pervades every aspect of our lives including the way health and wellbeing manifest. Some examples include (but are not limited to) disproportionate differences and/or disparities in:
• Risks
• Disease burden
• Susceptibility
• Treatment adherence
• Rates of diagnosis
• Incidence & prevalence
• Access
• Policies

Some of these key areas of disparity may be prevented at a clinical level, through appropriate physician training and education that would improve patient-provider relationship. It is essential to recognize the diversity of the community that the US physicians serve, and be able to accommodate and offer care for patients from all walks of life.

To learn further about national effort to reduce health disparities through incorporating CLC into CME, please visit:

US DHHS Office of Minority Health - Think Cultural Health: Bridging the Healthcare Gap Through Cultural Competency Continuing Education Programs

For an example of a regional effort to reduce health disparities through CLC training in CME, please visit:
UCSF Center for the Health Professions: The Network for Multicultural Health


For additional information on CLC and CME, please visit the resources page of our website:

*California Assembly Bill Number 1195 amending Division 2, Chapter 5, Article 10, Section §2190.1 of the Business and Professions Code. (2005).

The IMQ CLC program is funded by the California Endowment, a private, statewide health foundation that is working to expand access to affordable, quality health care for underserved individuals and communities in California, and to promote fundamental improvements in the health status of all Californians. For more information, please visit their website.

ACCME Release Executive Summary of March Board Meeting

The Accreditation Council for Continuing Medical Education (ACCME®) recently released the executive summary of their March 2009 Board of Directors Meeting. To view the full summary click here.

Highlights include:

The ACCME will not be taking any action regarding eliminating commercial support of CME.

Although they reserved the right to reevaluate this decision in the future, the report states:

"The ACCME is committed to providing oversight of accredited continuing medical education that is developed in compliance with the ACCME® Standards for Commercial SupportSM and that includes commercial support and/or teachers and authors who have financial relationships with ACCME-defined commercial interests."

Accreditation Outcomes

Ninety-seven organizations were reviewed under the 2006 ACCME Accreditation Criteria. From those organizations:

• Five of seven initial applicants have received Provisional Accreditation
• Seven providers have been recommended for Accreditation with Commendation
• Five providers were put on Probation
• Forty-eight providers are required to submit a Progress Report because of noncompliance findings in at least one element of the ACCME® Standards for Commercial SupportSM.
  

Facilitation of a CME Funding Organization

The ACCME will begin the process of investigating the feasibility of creating an independent, single grant-making organization that would distribute unconditional grants to accredited CME providers.

ACCP Releases New CME Guidelines

In the March 2009 issue of The American College of Chest Physician’s (ACCP) journal Chest, ACCP introduced the first evidence-based guideline that evaluates the effectiveness of current continuing medical education (CME) practices and provide recommendations on how practices need to change in the future. View the guideline and recommendations online at www.chestjournal.org

The CME Center contacted ACCP, asking how the guidelines were developed and how the ACCP membership as well as the general public have reacted.

Answers from Lisa K. Moores, MD, FCCP, Co-Chair of CME Guidelines Panel and Ed Dellert, RN, MBA, Vice President of Educational Resources at ACCP appear below.

What was the major impetus for creating these guidelines? Was this a reaction to anything specific or did it just naturally rise to the top of your strategic priorities?

In 2005, the ACCP’s Medical Education committee and the Health and Science Policy committee recognized the need to assess its medical education curriculum. During this assessment process, a proposal was made to evaluate the literature to determine what CME tools and techniques are most effective in improving our physician members’ knowledge and skills. It quickly became clear that there was much more to be learned from this effort and that its potential impact could benefit not only the ACCP membership but also the medical education community as a whole. Thus, the ACCP proposed and obtained acceptance from the Agency for Healthcare Research and Quality (AHRQ) to identify and synthesize the evidence for the effectiveness of CME. Johns Hopkins University and ACCP used this literature review and expanded upon it for the development of this guideline.

What was the process for the creation of these guidelines? Were there any parts of the process that were challenging? Are there any specific tips you would give to other medical societies who are interested in creating something like this?

The purpose of this evidence-based guideline, based upon the Johns Hopkins systematic literature review, is to make recommendations to assist ACCP members, the ACCP Education Committee, and any others involved in CME to further the effectiveness of their CME programs. Although the level of evidence was generally of low quality, certain recommendations could be derived substantiating what is currently being conducted by CME providers. In addition, suggestions for further investigation and research were synthesized by the panel. During the Johns Hopkins’ literature review, a primary limitation became obvious: the differences in terminology used in CME activities and in conducting CME research. Examples of terminology variation include the terms used to define the educational interventions applied, the different target audiences, the multiple types of learning objectives, the diverse content areas, and the numerous educational teaching methodologies. This variation has led to a lack of standardized CME approaches and CME research including CME research controls. This clearly makes comparison difficult and quantitative syntheses impossible.

How do you think these guidelines will affect your CME programs? Have these recommendations been adopted by your CME committee yet, or are they planning to?

The guideline writing panel noted that a primary limitation in the literature review was the absence of or little formalized training in CME to date-- for both individual teachers and professional societies providing educational programs. Educational skills and knowledge needed by CME providers is not extensively reviewed in the literature.
Very few studies indicated or outlined the training needs necessary for CME providers. Going forward, this must be addressed. The ACCP has already begun this process by creating and implementing an educational curriculum that guides the development of all of our educational programs. In addition, the ACCP has created a 6-learning categorical system that correlates with its educational curriculum is used not only in the development of its individual activities but also is reflected in its CME certificate process as one of the end products that the physician learner can receive.

What has been the reaction you have received from your membership?

Too early to tell as far as the guideline is concerned. We anticipate feedback over the next few months to be coming in from ACCP membership and the CME community at large.

From the literature review, what was the main take-away you want executives to walk away with?

There are 7 areas that we would highlight from this guideline that executives will need to work with their education leadership toward developing:

1. Instructional techniques: That a CME program should use CME interventions with multiple instructional techniques in preference to a single technique to improve physician knowledge
2. Frequency of exposure: CME programs should use multiple exposures (sessions) to CME content in preference to a single exposure be used to improve physician knowledge.
3. CME programs should not just use AMA’s definition of CME and the terms articulated in this guideline (or their modifications) should be integrated consistently by CME practitioners and researchers as they develop CME programs and study the educational and patient outcomes of CME interventions.
4. Widespread dissemination, elaboration and clarification of the terms in this document is needed. They should be used by journal editors, specialty and professional societies and by the research community so future evidence reviews can reflect a common language and make future comparisons easier.
5. CME professionals and researchers need to explicitly consider the inclusion and documentation of teaching and learning principles in the design and implementation of further trials of CME. In addition, we suggest that, whenever possible, trials be designed to study the educational outcomes of such variables.
6. When studies of CME interventions are performed, that special attention to full descriptions of elements expressed in the Continuing Healthcare Education Study and Systematic Review Template (CHESST) be incorporated (highlighted in document).
7. We highly suggest that leaders in medical education and related fields foster (i) the identification of high priority research topics in CME research that would span the broad scope of CME and (ii) conduct scientifically rigorous studies of the process and effectiveness of CME that demonstrates the effect of CME programs on individual and collective physician learners who participate in these programs.

We thank Dr. Moores and Mr. Dellert for taking the time to prepare these answers, and we would also like to acknowledge the work of ACCP’s Senior Manager for Public Relations, Jennifer Stawarz, in facilitating this conversation.

And please let us know your opinion on the guidelines and the work of the ACCP in the comments section below.

What a Difference a Year Makes

Not surprisingly, the AMA’s Council on Ethical and Judicial Affair’s (CEJA) Report on Industry Support of Professional Education in Medicine, prompted strong and varied reactions, when they circulated a draft last year. (To read AAMSE’s official reaction to the CEJA Report click here). Some responders aimed their heaviest criticism at the process CEJA used - it afforded little time for meaningful input before CEJA submitted it to the AMA’s House of Delegates for review. (At the end of the day, the report died a quiet death on the delegate floor.)

The issue of industry support for professional education in medicine is as relevant today as it was last year – if not more so. So, CEJA is again drafting a report for this year’s AMA’s House of Delegates Annual Meeting. The good news is it looks like CEJA listened to the complaints! CEJA, along with the AMA’s Council on Medical Education, reached out to the CME community early in the process by inviting key stakeholders to a facilitated discussion in late February. Kudos go to Regina M. Benjamin, MD, MBA and Claudette C. Dalton, MD, chairs respectively of CEJA and the Council on Medical Education, for making sure that, this year, stakeholders had time to consider the issues and provide input.

Invited stakeholders included the ACCME, the Alliance for CME, AAMSE, CMSS, PHARMa, and various medical societies, among others. Each organization’s representative was asked to share responses to the following questions:

1. When is conflicted expertise essential in CME? How can we tell when it is no longer needed?
2. What unique challenges do you as a stakeholder face regarding CME?
3. How can we ensure that medicine sets the agenda for CME overall so that it meets the needs of patients and physicians rather than the interest of commercial support?
   

How would you answer these questions? Leave your responses in the comments section below.

And check back later, when Shelly Rodrigues, AAMSE’s representative to this meeting and chair of the Medical Education Leadership Forum will share AAMSE’s response and her meeting take-aways.

Massachusetts Gift Ban Rules Approved

Massachusetts officials gave final approval for the rules banning pharmaceuticals and medical device manufacturers from providing gifts and other perks to physicians.

For the complete story click here

To read the complete rules, click here

The Physician Payments Sunshine Act of 2009: Better or worse than the 2008 bill?

Medical society executives and presidents are wondering how the recently introduced bill, S. 301: Physician Payments Sunshine Act of 2009, would impact their physician members.

Introduced on January 22, 2009, by Senators Charles E. Grassley (R-IA) and Herb Kohl (D-WI) the Sunshine Act would require pharmaceutical and medical device manufacturers to report a wide range of payments or other transfers of value to physicians and physician-owned entities to the Secretary of Health and Human Services (HHS). Grassley and Kohl drafted a similar bill introduced in 2007 and modified by the House in 2008 but never acted on by Congress.

Comparisons between 2008 & 2009

Direct CME payments must be reported
Under the 2007 and 2008 versions, manufacturers were required to report payments made to physicians for “participation in a medical conference, continuing medical education, or other educational or informational program or seminar.” In other words indirect payments were included – payments made by medical societies, for example, using manufacturers’ sponsorship support. The 2009 bill omits this requirement and instead calls for a direct payment reporting system. It reads:

“In the case where an applicable manufacturer provides a payment or other transfer of value to an entity or individual at the request or designated on behalf of a covered recipient, the applicable manufacturer shall disclose that payment or other transfer of value under the name of the covered recipient.”

While it isn’t clear how HHS would interpret and formulate a rule based on this section of the bill, on first blush it looks as if manufacturers will not need to report medical education sponsorships paid to medical societies. But, payments made from the manufacturer directly to a physician for “…serving as a faculty member or as a speaker for a continuing medical education program” must be reported.

Reporting threshold changed – to $100

Cumulative payments valued at $100 or more must be reported. The 2007 bill originally called for reporting of payments as low as $25, an amount later raised, in 2008, to $500. The bill’s definition of payments or transfers of value encompasses 14 items but allows the HHS Secretary to define more.

Stricter state laws would apply

The 2009 bill preempts state sunshine laws except those where requirements are stricter.

What do you think?

American Academy of Family Physician President Ted Epperly, MD, welcomes transparency and agrees with the overall intent of the bill but worries that it “…could discourage physicians from participating in CME.” He considers this version overly onerous, saddling physicians with an inordinate amount of paperwork. Epperly wants a return to the 2008 version, which he considered the “right thing to do” but less restrictive.

Tell us what you think!

For additional information & commentary:

• Text of bill
• Track the bill
• Policy and Medicine: Physician Payment Sunshine Act 2009 Introduced
• AdvaMed Statement on Physician Payments Sunshine Act of 2009
• AAFP Expresses Concerns About Revised Physician Sunshine Act
• Statement of NLARx Director Sharon Treat on the "Physician Payments Sunshine Act"
• Statement from The Prescription Project, regarding the revised Physician Payments Sunshine Act
  

Serving the Public Interest – by Resolving Conflicts of Interest

For CME providers who enjoy developing procedures that address crucial requirements, complying with the Accreditation Council for Continuing Medical Education (ACCME)’s standard 2.3, could be a pleasure. The standard – designed to ensure the independence of CME activities from commercial interest – invites rigor and creativity. It requires the provider to “…have implemented a mechanism to identify and resolve all conflicts of interest prior to the educational activity being delivered to learners.” Because this standard is critically important and has engendered myriad approaches – according to provider – it represents a good starting point for CME Center discussions.

First step is identifying a conflict of interest. (A little more difficult than just knowing it when you see it.) When CME planners, faculty, managers, staff, authors, and reviewers report a financial relationship with a commercial interest – and the provider must require all persons involved with CME to report such relationships – the provider then determines whether the individual also has the opportunity to “affect the content of CME about the products or services of that commercial interest.” Also is key, here. A conflict of interest exists when the individual who reported the relationship also has the aforementioned opportunity. In short, financial relationship plus opportunity to affect content equals a conflict of interest, and a conflict of interest requires resolution.

Note, too, that the current ACCME standards call for disclosure of financial relationships with any commercial interest whereas the earlier standard used the term commercial entity. Interest conveys a broader, more encompassing concept than entity.

To learn more about resolution mechanisms, or how-to’s, as well as the philosophy behind the requirement, read the piece by Shelly Rodrigues, CAE, Chair of the Advisory Council for the Medical Education Leadership Forum and Deputy Executive Vice President of the California Academy of Family Physicians. Then tell us what you think and what you do!

Sidebar:
Check out a “Conflict of Interest Flow Chart for Continuing Medical Education Sessions” developed by the CME Leadership Forum located in the CME Resource Center.

An end to commercial support for CME?

Remember, last summer, when the ACCME posted a call for comments on several proposed policies, including this: “The ACCME believes that due consideration be given to the elimination of commercial support of continuing medical education activities.” Not surprisingly, the call netted quite a few comments by the September 12, 2008, deadline now posted on the ACCME Web site.

No surprise, either, that comments on the comments abound, see, for example:

The Policy and Medicine (blog) summary

Coalition for Healthcare Communication’s summary

Floyd Pennington’s blog

and

here

What did ACCME decide to do? Nothing, yet. The Executive Summary of the November 2008 Meetings of the ACCME Board of Directors reads, in part:

"The ACCME will continue discussions on these matters as it analyzes the feedback received…The issues presented in the calls-for-comment will be on the next several Board agenda…The ACCME does not plan on taking final action on these issues until the end of 2009."

Stay tuned!

Standards for Commercial Support – Do We Really Need Them?

Shelly B. Rodrigues, CCMEP, CAE

We’re all professionals, right? We always follow the rules, right? We know when a speaker is a mouthpiece for a drug or product, right? We get “conflict of interest,” right? So, why do we need a whole set of standards for commercial support and pages of guidelines on how to identify, manage and resolve conflicts of interest?

Dr. X., a well-liked physician, who has been a residency director, society president, and frequent lecturer, stops practicing medicine to take up continuing medical education. He’s well-liked, charming, a good speaker and he has many contacts with industry folks who enjoy working with him. He begins contracting with medical associations for a percentage of grants to “make rain” or bring in dollars for CME activities. He helps develop the courses, prepares the slides, recruits the faculty, chairs and usually speaks at the sessions – and each time he speaks the slide says, “Dr. X. declares that he has no financial affiliation with any company providing support for this CME activity.”

Does he have an affiliation? Is there a conflict of interest? You decide –

Now granted, this situation is the exception, not the rule, but we have all experienced these exceptions. The problem is that we have also borne the brunt of major new regulations, standards, initiatives adopted to deal with the exceptions. That said, the ACCME’s Standards for Commercial Support – while appearing to be over-onerous – are our protective blanket. They protect us from the Dr. Xs of the world, from the perception of promotional bias, from undue influence by industry, and maybe even from some of the Senator Grassley fall-out.

Understanding and implementing the standards are not all that tough – they require education on the part of everyone in your organization – from the CEO and education specialist to the annual meeting planning committee and Board members. There are many topics covered in the Standards, but as a first step, they require each of us to begin on the highest ground by identifying conflict, then managing and resolving it.

Identify: Ask each person who has even the slightest opportunity to influence educational content to complete a financial disclosure statement – before they are in a position to influence content. For example: all committee members, curriculum development teams, staff, and potential faculty should have a financial disclosure statement on file with you. We collect them annually (in January), and then before inviting someone to speak in April ask them to “check here” if their statement has changed since the last filing.

Manage: A process to identify, manage and resolve the conflict is vital. An algorithm for action will help guide the process. “If this, then that … if yes, then.” Check the sample we’ve developed for you. Simply having a slide at the beginning of a presentation declaring the conflict is no longer enough. You need to tell learners how the conflict has been managed or resolved.

Resolve: If an individual who has potential influence reports a financial relationships, for example, a research grant from a pharmaceutical company, that just so happens to be on a therapy you plan to present, this constitutes a conflict and you need to begin a process to resolve the conflict. Ask the speaker to recuse herself; have the speaker present on a different topic; ask the speaker to present only evidence-based findings; or require peer review.

The good news is that there is plenty of help out there:

• Accreditation Council for CME: On the ACCME Web site you’ll find FAQs about not only the standards, but all the CME criteria. You’ll also find sample conflict of interest statements, and links to providers who have earned commendation in their work on the commercial standards.
• Alliance for CME: The ACME has many resources available on its Web site as well, and offers several educational sessions – live and web-based – on a wide array of CME topics, including conflict of interest.
• National Faculty Education Initiative: The NFEI is a new initiative launched by ACME and the Society for Academic CME to facilitate faculty and provider development. The first offering is a four-part case-based course on conflict of interest.
• NC-CME: The National Commission for Certification of CME Professionals Inc launched the exam to certify those of us to do CME. The designation CCMEP shows that a professional has passed an exam that tests the many aspects of CME – from the ACCME standards to the nuts and bolts of a program.

Here’s my conflict of interest – I’m lucky enough to chair AAMSE’s incredibly talented Council for Medical Education Leadership Forum– the Council members are all experts in CME and continuing professional development, and we promise the Council will work diligently to make your lives easier.

We’ve already:

• Completed a baseline needs assessment survey with AAMSE members
• Presented our first session at the 2008 Annual meeting
• Gathered Web resources and made them available on AAMSE’s site via links
• Launched this new blog

And we will continue to offer educational sessions at AAMSE meetings – all with your needs in mind.

Got questions? Got comments? Let’s hear them.

Welcome to the CME Center!

Welcome to the Medical Education Leadership Forum's CME Center! Medical society executives realize that high quality continuing medical education (CME) is not only key for members but crucial to a society’s vitality. Question is – how to design, deliver, evaluate and improve your society’s CME programming and systems. All medical society executives, no matter how little they are involved in CME, need to keep a firm footing on the ever-shifting CME landscape, and that is what we are here for.

What you will find on this blog is:

• continuously updated resource library
• a CME events calendar
• timely commentary
• best practices;and
• a chance to be heard!

Check back often to get updated news and commentary on everything CME. To find out more about the members and goals of the Medical Education Leadership Forum, click here.