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O’Brien Overtures - “Areas of Non-Compliance with Regard to Standards of Commercial Support in RSS Programs”

sobrien

Background

Everyone knows that the SCS were updated in 2004, providers were required to demonstrate full compliance by May 2005, and yet why are so many organizations having problems with regards to disclosure in their RSS program?

The problem is multifaceted. Here are a few common issues:

  • Lack of knowledge on who must disclose and when that information is provided to the learners.
  • How disclosure information is to be made transparent to the learners.
  • Comprehending the necessity for a reviewer or moderator to provide disclosure information to the provider? To the learners?

Our Findings

In the past, RSS sessions offered by hospitals and medical schools were often not disclosing everyone who had influence over the content of the series. They marched to their own drummer, but in 2005 and again in August 2008 the ACCME made it crystal clear that every activity certified for CME credit must adhere to all of the SCS including RSS.

I often review RSS programs and I find providers are still not fully in compliance with Standards 2.1, 6.1 and 6.2. Everyone knows that the presenters must provide disclosure information to the provider and the provider must implement their mechanisms to identify and resolve COI and then disclose to the learners. But, course directors, CME planning committee members, moderators, and reviewers are often missing from the disclosure information provided to the learners. Why is this I ask? The response I often hear is: “We collect disclosure information from everyone in a position to influence the content and we keep that information in our files.”

This is not in compliance with the Standards of Commercial Support. Everyone—especially the course director and or his/her planning committee—were greatly involved in the development of the RSS. That person or committee had to:

  • Identify the practice gaps of their own learners
  • Determine whether or not the activity fit within the “scope of [that department’s] practice”
  • Assure that the format was appropriate for the setting, the learning objectives, and the desired results (including the rationale for selecting those formats)
  • Identify universal competencies that would be addressed throughout the series
  • Draft global objectives, topics, and most likely, select the presenters/faculty.

So, of course they had influence over the content of the CME series.

Like the course director, any moderators who engaged in the presentations, or had any control over the content, also had to make their financial relationships transparent to learners.

If the content was reviewed for resolution of COI, the reviewer also had control or influence over the content, as that person might have made recommendations for changes in the presentation, or asked that additional evidence be cited, etc. Again, this person influenced the content of the session, so any disclosure information provided to the provider (including the fact that there was nothing to disclose) must in turn be communicated to the learners in advance of the session or sessions.

The “Fix”

How can this problem be fixed? There is an easy solution. Develop a template that can be used by all departments offering RSS, as follows:

➢    On the template, designate a “Disclosure” box. In that box, clearly show where “Faculty” information is provided, “Planner” information is provided (this would include the course director and any committee members involved in the development of the series), “Reviewer “(if you use a reviewer, be sure that reviewer does not have any COI related to the session), and “Moderator.”

➢    If you don’t use a moderator, then don’t include that in your template. Make this document real to your organization, so that it will ensure you comply with all of the SCS.

Don’t forget to educate your course directors and department coordinators. If they “don’t know what they don’t know,” they will keep doing what they have been doing for years and years and it will not bear fruit when it is time for you to go through your re-accreditation process. The ACCME expects all CME providers to adhere to all of their Criteria for Accreditation, so RSS need to step-up and demonstrate full compliance as well. By the way, the ACCME is serious about this; we’ve seen clients either go on probation for this or have to submit a progress report!

Once you have educated those in control of the series on how to comply, then you need to keep monitoring to ensure those departmental representatives are making appropriate disclosure to their learners in advance of the activity. If you find they are not, go back and work with them. If they continue to disregard the disclosure requirements, counsel them again. If they still don’t comply, I recommend you adopt a “three strikes” policy. Suspend their credits until they can fully demonstrate compliance.

It’s your accreditation on the line, so work with the departments by educating them, providing them tools to comply and then monitor to ensure disclosure for everyone in a position to control is provided to learners.

I believe that your attitude and approach will garner you the best results. Let your course directors and planners know that you are there to help them, that this is in the best interests of the public and the organization, and obtain support from your management to assure they back you up. Make it a “win-win” and they will comply.

Written by sobrien

February 23rd, 2009 at 4:15 pm

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