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.

In January 2008, the ACCME released an updated RSS toolkit. In the memo attached to the toolkit, Dr. Kopelow emphasized the importance of developing RSS activities that support learning and change, as well as improvements in professional practice. He stated that RSS make up 40% of all certified CME in the US and this type of activity must be based on the professional practice gaps of the learners.
The ACCME expanded the requirements for RSS activities in 2008. Monitoring data for each series must continue to be gathered to demonstrate compliance with Criteria 2-11, and providers are now required to list each series within their RSS program on the summary report form that accompanies the Self Study for Accreditation document. Files for series listed on the summary report may be called for review by the ACCME during the accreditation process to demonstrate performance-in-practice.
The ACCME defined its expectation for RSS in terms of meeting Criterion 2 (gap analysis). Dr. Kopelow states, “Professional practice gaps can be those of individuals; however, it is more likely that in an institutional setting the gaps will be those of the healthcare team, or system, in which the learners practice. Providers must deduce the educational need that underlies the professional practice gaps.” He went on to provide questions that will assist providers in assessing the gaps, including the following:

• Why is it that the professionals have this gap?

• Is it because they do not ‘know’? Is it because they do not have an appropriate strategy in place to address the problem?

• Is it that they know what to do, but that they have not, or cannot, implement it?

Accordingly, then, RSS activities must be developed to make a change in clinical competence (strategy), performance or patient outcomes (Criterion 3), and they must be designed to allow for measurement of the changes (Criterion 11) in the series based on the designation outlined in the planning process (e.g., changes in competence and/or performance in practice and/or patient outcomes). Measurement of change can be determined either at the system or healthcare team level, the individual learner level, or within the community of professionals. The ACCME will review the monitoring data to ensure RSS are practice based learning opportunities that impact changes and improvements.
RSS offers opportunities for integrating CME into the process for improving professional practice, development of non-educational strategies to enhance change, collaboration in education, an opportunity to bridge identified barriers to change and to impact the scope and content of education offered within and beyond the organization in which CME is provided. (Criteria 16-22).

SP&A-Recommended Strategies for Demonstrating Your RSS Monitoring System

As mentioned previously, the monitoring requirements have not changed. They are provided as a reminder.  Providers that produce RSS are required to:

• Implement monitoring systems that demonstrate their RSS meet the ACCME’s Updated Criteria

• Provide evidence (e.g., reports) of their monitoring system(s) that meet the following expectations:

1. The ACCME expects that all series and all sessions within a series will meet ACCME’s Updated Criteria and be in compliance with ACCME Policies.  Providers’ monitoring systems must incorporate, measure, and document compliance with Criteria 2 - 11 and applicable ACCME Policies.
2. The provider must collect data and information from all series as a part of its monitoring system. However, data on each criterion and policy need not be collected from every series. For example, a CME provider may monitor Series A for meeting Criterion 2 and Series B for meeting Criterion.
3. Monitoring data may be derived from either (1) a sample of a provider’s sessions or (2) from all sessions. However, if sampling is used, it must be applied consistently for 10% to 25% of the sessions within each series across the whole accreditation term.
4. A provider must analyze the data and information and determine if the RSS has met ACCME’s Criteria 2 - 11 and the applicable ACCME Policies.
5. A provider must also analyze the data and information for Criteria 16 - 22 (only if the your organization intends to demonstrate it is a Level 3 provider). A provider would indicate that an RSS has met a criterion or is in compliance with an ACCME Policy if its monitoring system indicates performance—as outlined in the criterion or policy—is achieved in 100% of the sample.
6. The provider will report whether or not it has met Criteria 2-10 and is in compliance with the applicable ACCME Policies within the self study report.

If monitoring system data indicate that performance within the sampled series or sessions did not meet any one of Criterion 2 - 10 or an applicable ACCME Policy, then the provider must:

• Identify the problem and describe it within the chapter on Criterion 13

• Describe the implemented improvements within the chapter on Criterion 14

• Describe the impact of the implemented improvements in the chapter on Criterion 15

You may access the most recent documents and formats related to managing RSS programs at www.passinassociates.com/downloads/rss1.doc and www.passinassociates.com/downloads/rss2.pdf.

Upcoming Dates and Events to Remember:

• Alliance for CME Annual Meeting (January 28-31,2009). NOTE: If you want to schedule a brief work session with any member of the SP&A staff at the Alliance meeting, please contact Kathy Cseke as soon as possible to get on the agenda. Kathy can be reached at cseke@passinassociates.com.

• March 2009 Cohort Decisions Released (week of March 16)

• Upcoming 2009 ACCME Workshops (May 13-15; August 12-13; December 9-10)

• July 2009 ACCME Self Study Cohort Decisions Released (week of July 20)