2013 Joint KMS and MSMA CME Provider Conference

The Provider describes that its CME Committee sets the topics and educational goals of its CME activities. To ensure independence of its CME activities, a 3-step process is implemented for every CME activity via a “Faculty Disclosure Form…”

Provider XYZ – Faculty Disclosure Form  Step 1: You have been given this form because you are a faculty member who will be speaking/presenting information as part of this CME activity. Faculty speakers/presenters who refuse to disclose may not participate in the CME activity. If you are not speaking/presenting during the activity, you may disregard this form.

Provider XYZ – Faculty Disclosure Form  Step 2: Using the spaces below, please disclose any significant financial relationship(s) that you (or your partner/spouse) have had in the past 12 months with companies that produce health care goods or services that are consumed by, or used on, patients.

Provider XYZ – Faculty Disclosure Form  Step 3: Please sign below to attest that you will ensure that the content of your presentation will not contain information related to the clinical area of the financial relationships that you provided above.

This provider also resolves conflicts-of- interest by including a disclosure slide in each speaker’s presentation that states the speaker’s financial relationships with any pharmaceutical or medical device company.

Regarding the expectations for Criterion 7, please indicate whether the following conclusions about Provider XYZ’s performance are TRUE or FALSE:  1) The provider’s ‘Faculty Disclosure Form’ is adequate to identify individuals who need to disclose. i. True ii. False

 Standard 2.1 outlines the parameters of what constitutes a “relevant financial relationship” that requires resolution in Standard 2.3.  To have a “relevant financial relationship”, a person must be (1) in control of the content of the CME activity, (2) have had, within the past 12 months, a financial relationship with an ACCME-defined commercial interest.

 The financial relationship is also considered relevant if it is a relationship that the spouse/partner of the person (who controls the content) possesses.  In the case, “Step 1” of the Faculty Disclosure Form will fail to get disclosures of financial relationships from the CME Committee members who control the content of the activities by selecting topics and educational goals.

2) The provider’s ‘Faculty Disclosure Form’ describes a valid process to resolve conflicts of interest. i. True ii. False

In this case, the Provider’s approaches for resolving conflicts of interest (Criterion 7, Standard 2.3) do not meet the expectations for compliance. An attestation (eg, via the Faculty Disclosure Form) is not—by itself—sufficient to satisfy the expectation that the Provider resolves conflicts-of-interest.

 Standard 2.3 expects that the Provider identifies and resolves conflicts-of-interest through its active engagement with those who possess relevant financial relationships.

3) Disclosure to learners, by using a slide in each speaker’s presentation as described above, is a valid mechanism to resolve conflicts of interest. i. True ii. False

The disclosure of relevant financial relationships to learners—required by Criterion 7, Standard 6—is not a valid mechanism for resolving conflicts of interest.

4) The provider’s process(es) will yield adequate information about relevant financial relationships with commercial interests. i. True ii. False

Standard 2.1 requires that providers have information regarding the financial relationships of those who control content with ACCME-defined commercial interests.

 “Step 2” in the provider’s ‘Faculty Disclosure Form’ does not use the ACCME definition of a commercial interest—eg, does not include entities ‘marketing, reselling or distributing’ health care goods or services—and may fail to identify all financial relationships with commercial interests.

 Further, Standard 2.3 does not include a deminimus amount for financial relationships. Therefore, the Provider’s expectation for disclosure of “significant” financial relationships will not yield all financial relationships.

5) Which of the following examples would NOT be considered a valid mechanism to “resolve all conflicts of interest prior to the education activity being delivered to learners” per Criterion 7, Standard 2.3?

 a. Each faculty member participates in a ‘planning interview’ with CME staff in which they discuss approaches to reduce bias in the CME activity. After content for the activity is submitted to the CME office, CME staff communicate with the faculty via s regarding modifications to the content.

 b. After the CME activity, an electronic survey is sent to each of the attendees asking whether they perceived commercial bias during the educational session. Comments submitted via the surveys are shared with the faculty from the CME activity.

 c. The CME activity content is sent out to an outside reviewer who is asked to complete an ‘Activity Review Form’. The provider keeps notes on the form about changes made by the CME staff prior to the activity.  d. All of the above.

b. After the CME activity, an electronic survey is sent to each of the attendees asking whether they perceived commercial bias during the educational session. Comments submitted via the surveys are shared with the faculty from the CME activity.

 Criterion 7, Standard 2.3 requires the resolution of conflicts of interest prior to the educational activity being delivered to learners.  The scenario of a post-activity survey for bias is not a valid approach to resolving conflicts- of-interest prior to the activity.

After discussion of provider QRS’s survey materials, your CME committee has come to a finding of noncompliance for Criterion 11 based on the following information received through the reaccreditation process:  The provider measures the impact of its Regularly Scheduled Series (RSS) via an electronic survey issued on a quarterly basis to all “Grand Rounds” (eg, RSS) attendees that asks the questions: “Did the educational activity help to increase your knowledge of this topic?” and “Are you going to make a change in your practice as a result of your participation in the Internal Medicine Grand Rounds?”

 The provider creates data tables that compare and contrast the number of respondents who responded “Yes” or “No” to the questions for each CME activity it conducted during each the 4 years of its accreditation term. From the table, the provider draws the conclusion that its CME Program has had a positive impact on changing physicians’ knowledge, competence and performance across several topic areas.

6) Which of the following statements most accurately describes the reason(s) that the provider’s process does not meet expectations for Criterion 11?

◦ a. The provider did not demonstrate that it has information about what specific changes (eg, competence/strategies, performance) learners made to their practice as a result of the educational activities. ◦ b. The provider only measures the impact of its Regularly Scheduled Series (RSS) on a quarterly basis.

◦ c. The provider’s electronic survey tool, as an assessment of learner change, should not include questions about changing participants’ knowledge. ◦ d. a. and b. ◦ e. All of the above.

In the case scenario, the provider’s electronic survey to measure change in its learners asks for a “Yes” or “No” response to whether the learner will change their practice as a result of the educational activity.

This data is not sufficient to fulfill the expectation of Criterion 11 that the Provider, “analyzes changes in learners’ competence, performance, or patient outcomes.” In order to satisfy that requirement, Providers need to have data or information about what specific changes have occurred in learners’ competence (strategies), performance or patient outcomes.