Life Science Compliance Update

May 05, 2015

ACCME Updates Disclosure Policy For Commercial Support

*CME Providers may now use hyperlinks to link to disclosure information

*Also, starting May 1: All commercial logos must be removed from educational materials and disclosures in accordance with last year's decision

 

Accme

The Accreditation Council for Continuing Medical Education (ACCME) now allows for accredited CME providers to use tabs and hyperlinks to transmit disclosure information to learners at educational activities. ACCME notes that this revised policy does not affect the actual disclosure requirements under the Standards for Commercial Support, just the method for disclosure. Furthermore, one year after ACCME modified its logo policy, no educational material or disclosures should contain a commercial logo or slogan. Materials may still state the name, mission, and areas of clinical involvement of commercial interests.

Updated: 5/5/2015: We previously indicated that starting May 2015, there is "no longer an exception" to the new logo policy for materials that existed at the time of ACCME's April 2014 policy. ACCME has indicated that there was never a specific exception for these materials, only an extended timeframe for accredited providers to come into compliance with the new rules. CME providers were told that they did not need to discard their current materials and reprint them without a logo, but that they were expected to make the changes by May 2015 into all current and future CME materials. ACCME states: "After May 2015, the ACCME will begin to find providers in noncompliance if logos of ACCME-defined commercial interests are included with disclosure of commercial support."

ACCME requires all commercial support to be disclosed in a specific manner, in accordance with their Standards for Commercial Support (SCS):

ACCME SCS: Disclosure Relevant to Potential Commercial Bias

  • Standard 6.1: An individual must disclose to learners any relevant financial relationship(s), to include the following information: The name of the individual; The name of the commercial interest(s); The nature of the relationship the person has with each commercial interest.
  • Standard 6.2: For an individual with no relevant financial relationship(s) the learners must be informed that no relevant financial relationship(s) exist.  
  • Standard 6.3: The source of all support from commercial interests must be disclosed to learners. When commercial support is "in-kind‟ the nature of the support must be disclosed to learners.  
  • Standard 6.4: 'Disclosure' must never include the use of a corporate logo, trade name or a product-group message of an ACCME-defined commercial interest.  
  • Standard 6.5: A provider must disclose the above information to learners prior to the beginning of the educational activity.  

"In a continuing effort to simplify compliance expectations and make them consistent across activity types, the ACCME has decided to allow accredited CME providers to use tabs, links, or other electronic mechanisms to transmit disclosure information to learners for CME activitiesm" states ACCME. Previously, CME providers were restricted from using methods such as electronic tabs or links and had to "use a method that ensured learners passed through electronic disclosure information before engaging in an activity."

"Now, CME providers can make electronic disclosure information available via an electronic tab or link, just as they have always been able to make disclosure available via a tabbed section in a printed syllabus."

"Regardless of the method, the ACCME expects—as it always has—that disclosure information will be delivered prior to the beginning of the CME activity and will be clearly marked, accessible, and useful for learners," ACCME advises. 

As noted in Standard 6.4, last year, ACCME elected to disallow the use of company logos on educational materials and disclosure information. ACCME CEO and President, Dr. Murray Kopelow, discussed the modifications in a webinar, noting that a CME provider's "acknowledgment of commercial support as required by Standards 6.3 and 6.4 may state the name, mission, and areas of clinical involvement of an ACCME-defined commercial interest but may not include corporate logos and slogans."

He stated that this change is effective immediately but does not apply to currently printed existing materials. CME providers "do not need to throw them out and reprint them, but you do need to make all of these changes and incorporate this new policy by May 2015 into your printed materials and your Internet presentations of continuing medical education."

Kopelow also clarified: 

I want to emphasize that this change only applies to mixing educational materials and logos and only applies to mixing disclosure of commercial support and logos; it applies to nothing else. It is not relevant to when a speaker mentions a brand name in your educational materials or if you're using a device to teach accredited continuing medical education and that device has a logo or brand on it. You don't have to remove that logo from the device.

 

February 02, 2015

ACCME Update: Murray Kopelow Offers Recommendations For European CME Accreditation; Provides Thoughts For The Next Generations of CME Learners

KOPELOW

Last week, Dr. Murray Kopelow, president and CEO of the Accreditation Council for Continuing Medical Education (ACCME), offered his insight into two important areas of continuing education: international CME and the challenges CME faces for the next generation of physician learners. 

European Accreditation for Continuing Medical Education

Continuing medical education accreditation systems in Europe and the United States are very different from each other. "The majority of accredited CME in Europe comes from individually accredited activities either by the national accreditation authority or by the UEMS, while in the United States, the majority of accredited CME is delivered by CME providers, accredited within the ACCME system," writes Dr. Kopelow. 

He believes the U.S. model has developed at least in part because of the link between accredited CME and physicians’ maintenance of licensure and specialty certification. "Virtually every doctor in the United States is involved in a professional regulation system that requires, or expects, participation in accredited CME," Kopelow notes. This has contributed to a more unified licensure requirement than abroad. "These uniform regulations affect more than 90% of the licensed physicians in the United States," he states.

"The ACCME system has always been a provider-based system and remains so because of the economies of scale and scope it offers in addressing the task of the quality assurance of so many activities every year," Kopelow writes. "This provider-based system has been an efficient distribution channel for a single CME standard applied to the 130,000+ ACCME-accredited CME activities offered by 2,000+ providers for 24 million physician and non-physician registrants per year."

Dr. Kopelow recommends that "perhaps, a step forward in Europe would be a single set of CME/CPD accreditation standards, promulgated by a committee whose members represent the various types of CME provider organisations that could exist in Europe." As with the ACCME, the European model would "need not accredit activities or providers but rather it could simply oversee the accurate application of its requirements by other organisations which it has deemed acceptable accreditors."

View Dr. Kopelow full article: Journal of European CME 2015, 4: 27103, available at http://dx.doi.org/10.3402/jecme.v4.27103

 

Dr. Kopelow also took up another challenging question last week when he addressed, what is the future of continuing medical education?

"As you might imagine, the ACCME...is thinking about and asking whether our system is ready for the future of continuing medical education," states Kopelow in a video commentary, available here

"Of the 856,000 physicians that are operating now in the United States, many of them were born after 1980," he notes. This group of millennials are the group of physicians that accreditation systems like the ACCME need to plan for going forward.

Currently, less than 10 percent of the physicians are under 30 years of age. Over the next 20 years--"over the period of time during which I was the CEO of the ACCME," notes Kopelow--50 percent of the physicians in the United States are going to have been born after 1980.

Kopelow believes that this group, having essentially grown up using Google, YouTube, and Skype has integrated technology into their lives in an entirely different way than previous generations. Quick access to information, of various levels of quality, is now a way of life.  

Furthermore, blogs, Twitter, LinkedIn discussions etc. allow for interactive discussion with others. Kopelow states:

This is a group, synchronously, asynchronously, getting together, learning about some issue, and discussing some issue. And it would seem that the skill involved here is different than the one that's present in the current system. Here, people are going to have to be challenged and have the ability to validate the content. To determine whether what they're hearing and seeing is something that should be integrated into their practice. It isn't going to be, have any value to accredit Twitter because Twitter is not going to really have any control over what happens here.

...

[Today's] models were built from a framework of people saying: I know what my professional practice gap is. And I know what the framework is for me to address those. I have to do it in the context of a competency. There's a certain subject that I have to go get information about and I have to modify my knowledge, competence, or performance and that will satisfy the educational needs. But is that going to be [how] millennials, are going to operate? And is that enough of a construct for the accreditation system, for the standard setters, being explicit about obligations and expectations? When in fact, in 20 years from now, people are going to recognize what their professional practice gap is, but they're going to find that learning in certain communities and locations via certain unpredictable, unknown media. And it is that context in which they're going to be doing their learning and changing. Don't we owe it to these people to establish a context and a set of rules and requirements and expectations for behavior in those opportunities?

While his commentary doesn't offer a concrete solution, Kopelow has provided a lot to dwell on as the ACCME changes leadership in the next few months. 

 

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