Posted on August 28, 2023

SORTING OUT ISSUES WITH THE MITIGATION OF STOCK OWNERSHIP AND STOCK OPTIONS

As most of you know by now, the ACCME (and JA) require that – when determining mitigation strategies for relevant financial relationships – you distinguish if the stock is publicly traded or if it is from a privately held company. In and of itself, this process is onerous for most CE providers. Before moving on, we want to clarify this rule:

PUBLICLY TRADED VS PRIVATELY HELD STOCKS

If a person that is affecting the content of a CE activity owns stock in a PUBLICLY TRADED ineligible company (“publicly traded” means a company whose ownership is organized via shares of stock which are intended to be freely traded on a stock exchange or in over-the-counter markets. A public company can be listed on a stock exchange, which facilitates the trade of shares, or not) stocks they own are considered a normal financial relationship and are mitigated in the standard way most providers, which is normally to have the slides of a presenter reviewed by a non-conflicted reviewer or by having a planner paired with another nonconflicted planner who makes all of the decisions. But if that person owns stock in a PRIVATELY HELD INELIGIBLE COMPANY, ACCME considers those stock holdings to be the same as ownership of the company. In other words, those persons would be excluded from participating in CE (unless one of the three exceptions to this rule can be met).

WHAT ABOUT STOCK OPTIONS?

“Stock Options” are defined as contracts to purchase stock in the future at an agreed-upon price.

The ACCME has stated state that if you have determined that a company is ineligible, and an individual has stock options with a publicly traded company, we would not consider that individual to be an owner, but we would consider them to have a financial relationship which may need to be mitigated and disclosed if the CE content they are controlling is related to the products or business lines of their company.

By contrast, if an individual owns stock in a privately held company, ACCME considers that individual to be an owner of the company who must be excluded from controlling content outside of the exceptions to Standard 3.2. Further, the ACCME has stated that individuals who may be in a position to control accredited continuing education are expected to disclose all their financial relationships with ineligible companies within the past 24 months to the provider, including contracts to purchase stock at an agreed-upon price (stock options). As described in Standard 3, the provider is expected to determine if the relationship, in this case, stock options, is relevant to the educational content. If so, the provider needs to take steps to mitigate the relationship and disclose the relationship to learners.

An individual who holds stock options in an ineligible company is not considered an owner or employee of that ineligible company.

But, as described in Standard 3, the provider is expected to determine if the relationship, in this case, stock options, is relevant to the educational content. If so, the provider needs to take steps to mitigate the relationship and disclose the relationship to learners. Or, to state this another way [from the ACCME] “If an individual has stock options with an ineligible company that have not been exercised, we consider them to have a financial relationship with that company which, if relevant, would need to be mitigated and disclosed in keeping with Standard 3.”

To summarize:

• Stocks from a publicly traded ineligible company whose products are relevant to the content of a presentation or the activity itself and held by persons that affect the content of a CE activity must be mitigated and disclosed to learners per normal procedures.
• Persons that own stock from privately held ineligible companies relevant to the content of a presentation or the activity are considered to be owners of that company. As such, they are ineligible to participate in CE activities and must be excluded (except when one or more of the exceptions to this rule are valid).
• Ownership of stock options – exercised or not – are considered to have a financial relationship with that company, which, if relevant, must be mitigated and disclosed to learners regardless of whether the company is publicly traded or privately held.

Please note that there are a number of potential “what ifs” that you might encounter, such as if the company is acquired, the stocks are sold, and/or the company goes public etc. Please contact us when such unusual situations occur.

WHAT IF THE STOCK OPTIONS ARE FROM A START-UP?

A question has arisen as to whether a person with a financial relationship with a PRIVATELY HELD startup should be excluded from CE. The ACCME definition of a “startup” is a company that has begun the governmental (FDA) regulatory process for a product in development.

The question is whether a presenter who has a relationship with the company can have a role in an activity. The ACCME has provided clarification about this question by stating that “it would not have any bearing on determining whether an individual is an owner of that company.” In other words, ACCME is taking a broad brush to this issue and erring on the side of caution by including financial relationships with such companies. This is true whether the company is privately held or publicly traded.

We know these issues are complex, and we hope this Client Advisory has clarified them. If you have questions, please reach out to Steve Passin at passin@passinassociates.com.

Posted on June 19, 2023

The distinction between stocks in publicly traded organizations and privately held companies

As you may know, more than a year ago the ACCME began requiring that “stock ownership” in privately held companies be mitigated differently than with publicly traded organizations. As such planners or faculty reporting that they own stock in any amount with a privately help Ineligible Company be treated as if  that person “owns” the company. This means that the person is not eligible to participate in CME/CE activities when the products relate to the presentation.

The ACCME has indicated that they intend to enforce this requirement despite the difficulties many providers are having making the determination and having to replace the planner or faculty. They have indicated that a few bad apples in the CE Community have been using the complexity of organizational structures to hide these relationships. This is important if you are jointly providing the activity with a non-accredited entity.

Be aware that developing procedures for making this determination is important. If you have questions or need assistance, don’t hesitate to contact Steve Passin, president, at passin@passinassociates.com.

Posted on May 10, 2023

Mitigation of Stock Ownership with Privately Held Companies

General Overview of This Issue
The Accreditation Council for Continuing Medical Education (ACCME) has indicated that when people involved in accredited CE own stocks in privately held companies, they must be treated as owners of those companies.

Here is the rule from ACCME:

• Individuals who own stock (not through a mutual fund or pension plan)in privately held ineligible companies are considered owners or employees and therefore must be excluded from controlling content or participating as planners or faculty in accredited CE, unless they meet the exceptions to the exclusion described in Standard 3.2.
• Individuals who own stock in publicly traded ineligible companies are not considered owners or employees. As described in Standard 3, the provider is expected to determine if the relationship is relevant to the educational content. If so, the provider needs to take steps to mitigate the relationships and disclose the relationship to learners.

This means that unless there is clear evidence that one of the three exceptions to the rule can apply, such planners and presenters must be disqualified from participation in an accredited activity.

As a reminder, here are the three possible exceptions to the rule:

1. When the content of the activity is not related to the business lines or products of their employer/company.
2. When the content of the accredited activity is limited to basic science research, such as pre-clinical research and drug discovery, or the methodologies of research and they do not make care recommendations.
3. When they are participating as technicians to teach the safe and proper use of medical devices, and do not recommend whether or when a device is used.

This is an area we have observed that both the ACCME and Joint Accreditation (JA) are rigidly enforcing. Hence, our recommendation is that if the reported relationships with privately held companies are present, be conservative and replace the planner or presenter with some one that has a mitigable financial relationship or no relevant financial relationships.

Deciding of a Relationship is with a Privately Held Company

Remember that you cannot rely on the person with the conflict to determine how to mitigate. As the accredited provider, it is your responsibility to reach a judgment. Some steps to consider include:

• Google the company. In the ‘about us’ section of their website, you should be able to tell if the company is publicly traded or privately held.
• If Google is not definitive, then consult your organization’s financial experts to ask for help.
• Also, consider consulting the activity’s course director for input.
• When looking at relevance in terms of the products the manufacturer produces and their relationship to the topics of the activity, always be conservative and if there is any potentially relevant relationship, disqualify and replace!

As always, if there are questions or concerns, please contact Steve Passin at passin@passinassociates.com. And please visit our website: www.PassinAssociates.com.

Posted on May 10, 2023

Plan ahead for your initial Interprofessional Joint Accreditation

Thinking of applying for your initial Interprofessional Joint Accreditation (Joint Accreditation)? If so, consider these best practices to ensure a successful result:

• The shift from an individual accreditation, such as Accreditation Council for Continuing Medical Education (ACCME) to Joint Accreditation is not just a conceptual exercise. It takes 18 months of advance planning!
• Essentially, to successfully attain JA, you must operate as if you are already accredited by JA insomuch as you must understand and implement the JA Criteria for Accreditation and the Standards for Integrity and Independence in the educational activities you offer. This will enable you to demonstrate to JA a mastery of their requirements.
• Don’t rely on another organization with whom you may be partnering to demonstrate compliance because they may not be up to speed on the requirements. You need to understand them and master them.
• Develop your own JA Planning Guide. One builds this Guide based on the Planning Criteria (JA Criteria 4-10) and Standard 3 of the Standards for Integrity and Independence to be able to collect the correct information about planner and faculty financial relationships with ineligible companies, and then vet those disclosure forms to determine which reported relationships are relevant to your CE activity.
• Remember that planning JA activities does not take place in silos in which you inquire about needs from physicians, and then inquire about needs from nurses, etc. ALL planners must be on an even playing field and communicate with each other about their roles, functions, and impact on patient care.
• Remember that you must plan a minimum of 25% of your total educational activities by and for the healthcare team.
• Start immediately to add new evaluation questions that measure the impact on your healthcare team – both to measure improvements in Skills/Strategy (intent to change) and Performance (actual implementation in practice 2-4 months after the educational activity).
• Be aware that JA activities must be interactive so that your attendees learn with, from, and about each other. This is the essence of JA.
• Interested in JA Accreditation with Commendation? This also takes many months of advance planning to achieve compliance with the seven advanced commendation criteria you select to demonstrate. Be wide-eyed about what each commendation criteria requires, take an honest look to see if you are already compliant for each criterion or if you can be compliant. Create a Tracking Sheet to manage your commendation progress.

Have questions? Need answers? Feel free to reach out to Steve Passin from PassinAssociates at passin@passinassociates.com, or visit our website: www.PassinAssociates.com

Posted on October 12, 2017

Part II: Add MOC to Your CME! Practice Assessment and Patient Safety

By Karen J. Kaminskas, MS. Ed., CHCP

This follow-up article discusses how to align ABMS Member Boards’ MOC practice assessment and patient safety credit to your CME activities, which aligns with the ABMS Member Boards’ MOC program requirements.

Read the full article here: Practice Assessment and Patient Safety

Posted on July 5, 2017

Add MOC to Your CME! As Simple as 1-2-3

By Karen J. Kaminskas, MS. Ed., CHCP

This article discusses how to add ABMS MOC Part II: Lifelong Learning credit to your CME activities, which aligns with the ABMS MOC program requirements for Part II credit obtained from participation in certified CME activities. Additional opportunities for aligning MOC credit to your activities for other MOC Part II requirements, such as self-assessment and patient safety or MOC Part IV Practice Improvement, will be addressed in subsequent newsletters.

Read the full article here: MOC Simple as 123

 

Posted on September 11, 2015

Reflections on How to Choose Your Best Examples for ACCME Chapter on Educational Activities (C2-7)

Over the years, I have listened to clients struggle over the decision about which of their activities should be discussed in their examples for C2-7. Regardless of whether they have thousands of examples or a few dozen, the discussion always seems to go something like this:

 

We want to put our best foot forward … We want to use our best examples … We had tremendous responses for this particular activity. Let’s use this one … We received lots of commercial support for that one … We had hundreds/thousands of attendees at this one! We should use it.

 

In all cases, of course, they are trying to make the best selection for their two or three examples for C2-7.

 

The ACCME guide asks providers to ‘tell their story’ and so they should. But like any good author, some of the initial questions should be: Who is my reader? What are they looking for in my examples?

 

Launching off with your ‘best’ as described above doesn’t always answer those two questions. Often it isn’t until two-thirds of the way through writing the first or second example when writers throw up their hands up in the air and start over with another example. This is often because while they realize that maybe the format was great, their documentation of the resolution process wasn’t up-to-par; or, they realize that their compliance with the SCS was stellar, but their underlying educational needs documentation was weak.

 

So with the above considerations as context, the following thoughts represent a few ideas to avoid these frustrations:

 

1. Start with the criteria and follow the ACCME guide exactly. This seems obvious but it isn’t. Before your fingers hit the keyboard, think about your examples from the specific guidelines laid out in: C2-A (gaps), C2-B (underlying causes), C3, C5, C7 and the applicable SCS. That is it – nothing else (click here to link to ACCME guide to reaccreditation) or click on QR Code #1 below, left.

 

2. Review the criteria that the surveyors are asked to complete when they review your self – study. Start with the end in mind and ‘teach to the test.’ This is a mantra that I heard many fellow teachers remark upon as they faced standardized testing for their students, and I think that it is highly relevant here (click here to link to the ACCME surveyor report form) or click on QR Code #2 below, right.

 

3. There are no ‘extra’ marks for an in depth discussion about collaboration or sterling evaluation outcomes. There is an opportunity to talk about those criteria in C11-13 and C16-22; it just isn’t necessary in this chapter.

 

4. Think carefully about what is required for the SCS. Importantly, can you clearly address and provide evidence of disclosure received in a timely manner for everyone that affected the content of the activity (planners, reviewers, faculty, editors, and staff if appropriate)? Second, can you demonstrate that the information collected is relevant? Third, can you demonstrate that relevant conflicts of interest were resolved? Finally, can you demonstrate that all relevant financial relationships were disclosed to learners? In addition, can you demonstrate how you ensured that your activity was developed free of the influence of any commercial interest? Each of those elements is important and required for compliance.

 

5. If you receive commercial support for your overall CME Program, consider selecting a commercially supported activity as one of your examples. If you have both enduring and live activities, then choose one enduring and one live. Do you have both direct and joint providerships, then choose one of each. The aim here is to avoid, as much as possible, a repetition of the process for each example. That being said, stick to the yardstick and focus your description on exactly what the ACCME guide asks of you.

 

6. Consider starting each of your examples with an overview of the activity in order to give your reader an idea of the genesis of the activity and a brief description of the scope of the activity. All of this introductory information provides the reader a ‘fly-leaf’ orientation before digging into the criteria.

 

7. If you are suffering from a serious writer’s block, consider picking your favourite criterion, or one that you are most familiar with, and write it first. Then move throughout the criteria and build the chapter as you continue writing.

There is no question that C2-7 is a big chapter with lots of criteria and their documentation including the SCS. But using a few of the tactics and techniques outlined above will go a long way toward avoiding false starts, allows a more efficient use of precious time, and provides straight-forward evidence of compliance.

 

Posted on September 11, 2015

Updated Policies and Procedures

During the summer months, it may be a good time to make sure your CME Policies and Procedures are up to date. We have revised the following documents in 2015:

 

• Policy on Commercial Support (Updated 4/1/15)
• Policy on Content of CME (Updated 4/13/15)
• Policy on Internet CME (Updated 5/3/15)
• Joint Providership Agreement (Updated 5/15/15)

All of the above forms are Word documents; so you should have no problem customizing them to meet your needs. As always, let us know if you need any assistance with Policies and Procedure Documents.

In case you’ve misplaced the 2015 log-in credentials, they are as follows (Please note that fields are case sensitive):

 

Username: Client
Password: Passin2015

 

Posted on September 11, 2015

High Value CME! – ABIM and the ACCME

The ACCME and the American Board of Internal Medicine (ABIM) have announced a new collaboration that will both streamline a documentation process and, more importantly, further contribute to high-value CME. The collaboration will recognize CME providers as a one-stop shop for physicians who will be able to receive ABIM MOC credits at the same time that they also achieve CME credit. Currently, ABIM is the only entity currently collaborating with the ACCME, but the latter is actively negotiating with other boards to establish similar relationships for the future.

 

The purpose of this article is to highlight some of the requirements for those CME providers who wish to offer CME credits that also conform to the ABIM MOC credits.

 

Currently, if a CME provider wishes to create an activity for which there is MOC credit, the provider must submit an application to the ABIM for approval and peer review. This process is time consuming and labor intensive. The new collaboration suggests that CME providers will no longer be required to submit an application for MOC credit. Instead CME providers will use the Program and Activity Reporting System (PARS) as the gateway to ABIM MOC. Beta testing of the new system with PARS is underway, with a view to full functionality by the end of 2015.

 

The ACCME will maintain a list of activities that have met ABIM requirements and that are registered for MOC credit. Physicians will be able to go to the ACCME website where all courses currently approved for MOC will reside. The PARS technology, accessible through the ACCME site, will also communicate credits to the ABIM. As it stands now, nearly all formats are eligible except Point of Care (PoC) and manuscript CME.

A physician can access the ACCME site and make a choice to take MOC activities that are also registered for CME credit. It is up to the provider whether or not they will choose to make a CME activity eligible for MOC. In order to qualify, there are a few requirements for the CME provider that need to be met:

 

• Assess an outcome or conduct a posttest.
• Inform the learner of the result of each question of the posttest or outcomes response. The correct answer must be provided if answered incorrectly, as well as where to go to learn more about the content.
• Completion of new fields within PARS that include learner ABIM number and date of birth.
• Inherent in the above, is the amendment of the claim for credit form and/or the evaluation-outcomes method of submission.

 

In summary, the synergies of this collaboration are hard to ignore. It offers the opportunity to meet not only lifelong learners’ needs for CME, but also to offer MOC credits that are fundamentally tied to certification/recertification. This is collaboration is clearly a boon to any CME provider.

 

References:
1. ACCME: ABIM and ACCME Announce Collaboration in Support of Physician Life-Long Learning
2. Policy and Medicine: ABIM and ACCME Announce Collaboration in Support of Physician Lifelong Learning
3. ABIM: Maintenance of Certification Guide
4. Interview with ABIM staff

 

Additionally, you may access references by clicking on the below QR codes:

 

 

Posted on September 11, 2015

August 2015 SP&A Client Newsletter

Coming to Terms with ACCME Criteria 3 and 11
by
Judy M. Sweetnam, M.Ed., CHCP

 

The ACCME asks us not only to determine the educational outcome for a planned activity (C3), but also to measure its effectiveness (C11). We are given three choices for the educational goals that we are we seeking to achieve:

• A competence-based outcome, and/or
• A performance-based outcome, and/or
• A patient-based outcome.

 

Accordingly, the ACCME expects us to measure the effectiveness of the activity against the stated goals. If our activity is planned to change or improve competence, we evaluate for changes in competence. If our goal is to change or improve competence and performance, we design tools to evaluate our effectiveness in changing both competence and performance, and so on. Meanwhile, measuring changes in performance based on anecdotal changes in patient outcomes can still be fairly straight-forward if there are sufficient time and resources devoted to designing questions and analyzing learner responses. Of course, there are the problems associated with reliability and validity in a scenario where there are limited responses; but that is a discussion for another day.

 

Over the last four years, many of us have struggled with the definition of competence and, more importantly, how to measure the effectiveness of a competence-based outcome. (ACCME FAQ November 11, 2011). (Click on the highlighted title or click on QR Code #1, below.) The ACCME’s definition is based on Miller’s (1990) work, where he describes competence as “knowing how” to do something. Knowledge, in the presence of experience and judgment, is translated into ability (competence) – which has not yet put into practice. It is what a professional would do in practice, if given the opportunity. The skill, abilities and strategies one implements in practice, is performance.

 

The most straightforward and reliable way to measure this type of outcome is simply to ask learners how they will apply what they have learned from an activity. This type of qualitative, free text response, gives very rich data when completed appropriately. However, it also opens the door for poorly written one-word answers, or to nonsense responses when required as part of an online attestation for credit claim. In order to help address poor data, different formats (e.g., paired questions, pre/post questions) are created to measuring competence. Sadly, despite innovative design, some of these evaluation tools still only measure knowledge. Objective, measureable, statistically significant changes in knowledge gain are important but they are not what the ACCME ask for when they ask us to measure competence. How can this be so?

 

In searching out an explanation, it is useful to read one of the articles recommended in the AMA MedEd update: “10 Must-Read Articles for Medical Educators: Applying the Science of Learning to Medical Education,” by Richard E Mayer (Medical Education 2010; 44: 543-549). While many have struggled with whether their evaluation tools measure knowledge or competence, this latter article helps differentiate between the two:

 

Learning outcomes can be measured with retention tests and transfer tests. Retention test measure how well the learner remembers the presented material such as whether he or she is able to recall what was presented (e.g., ‘Define retention test’) or recognize what was presented (e.g., Remembering what was presented is an example of [a] a retention test, [b] a transfer test’. Transfer tests measure how well the learner can apply what was learned to new situations (e.g., Generate a transfer test item from this section’). P.546

 

In summary, the question to ask ourselves in determining whether we have created a tool that measures competence or knowledge is, “Does this tool address retention, or does it address transfer?” If I have addressed transfer as Mayer describes above, then, and only then, have I measured competence. Measuring retention misses the mark.

 

P.S. This article (click highlighted text or click on QR Code #2, below) is rich with instructional design pearls and their scientific rationale.