While you can’t eliminate the stress surrounding commercial independence compliance, you can reduce it. In this post, we’ll show you how to avoid compliance panic while mastering the commercial independence review process.
Ready to Make Your Declaration of Independence? Take This Commercial Independence Quiz First
ACCME commercial independence standards compliance was never meant to be easy, but it doesn’t have to be a slow and painful process. Although commercial independence compliance may appear complicated, understanding the steps to achieve and maintain ACCME standards can be simple to understand and implement.
Here’s a short quiz to help you gauge your compliance readiness:
1) Can I easily identify and detail any potential commercial independence conflicts among staff, affiliates, or sponsors and create a corresponding report regarding the remediation process?
2) Is there a unified system for delivering financial relationship disclosure documents to stakeholders?
3) Am I able to simply track the receipt and verification of commercial relationship disclosure documents through a single, secure platform?
4) Does my organization routinely notify new CME program participants, staff, and stakeholders of ACCME commercial independence standards using documents that can be tracked and responded to?
5) Can I easily demonstrate commercial independence compliance efforts with a series of reports that document our compliance strategy and results?
6) Have all staff and affiliates with influence over content and program management been made aware of my organization’s process of dealing with current or potential financial relationship conflict of interest via a trackable document?
7) Are commercial supporters provided with a simple report regarding ACCME-compliant financial relationship boundaries and regulations?
8) Are all documents presented with proper ACCME logo and trademarks intact?
9) Can learners and staff easily find any relevant financial disclosure notations on distributed documents and online?
10) Does your organization have a simplified method for finding current and archived commercial sponsorship data over the entire timeline of your CME program?
Viewing compliance as a system of analysis and response rather than a series of regulations is essential for meeting the challenge of ongoing compliance.
Didn’t get a perfect score? Fret not. The easiest way to manage the compliance process is to have a single, integrated data- and learning management system that allows you to monitor and direct compliance assurance activities from a single dashboard.
If you aren’t using an enterprise-grade LMS then you can still benefit from the following tips.
3 Scenarios that Might Present a Challenge to Your Commercial Independence Compliance
Regardless of your organization’s level of preparation for the Self-Study or attention to commercial independence guidelines, you are likely to face instances which challenge your ACCME standards savvy. Here are just a few examples:
1. A curriculum designer insists that a ground-breaking medicine developed by a Nobel Laureate’s new healthtech company should be included as a part of a new activity.
While the ACCME does not prohibit the use of trade names, it encourages generic names of products when possible. It also requires that relevant alternative therapeutic approaches be included alongside the trade name product or service when available. The content must focus on demonstrable improvements in healthcare not merely the product itself. Standards 5.1-5.2.
2. A new instructor discloses that their husband recently left the employ of a pharmaceutical company but refuses to reveal if they still own stock in the company.
According to the ACCME, any significant financial relationships (including that of a spouse) which occurred within the last 12 months must be revealed to the CME provider. This includes the ownership of stock. An individual who will not offer full disclosure of relevant financial relationships cannot be an instructor for an ACCME-accredited CME provider. Standards 2.1-2.2.
3. Your non-accredited partner is unable to fulfill their duties and one of their commercial sponsors, a medical equipment manufacturer, offers to step in to help with free textbooks, a guest speaker from the company describing the proper use of their equipment, and a location for a live-streamed educational event.
This is an easy one. The ACCME stipulates that a commercial interest cannot take the role of a non-accredited partner, even if their support is limited to the identification of educational needs. This standard also prevents commercial interests and their representatives from presenting CME content. Standards 1.1-1.2.
Become Compliance Efficient: How to Create an Action Plan for Resolving Commercial Independence Conflicts
The provider must have implemented a mechanism to identify and resolve all conflicts of interest prior to the education activity being delivered to learners.
Having a demonstrable method for resolving conflicts of interest is a requirement, but that doesn’t mean it has to be a burden. It can also be a “set it and forget it” system that allows you and your team to be compliance efficient in the future. Here are the 5 steps to take charge of potential commercial independence conflicts.
1. Own the documentation process. Ensure that there are commercial relationship disclosure forms at-the-ready which can be emailed and tracked.
2. Present the financial relationship disclosure forms to every new hire along with a succinct summary of current ACCME regulations for CME provider staff and affiliates.
3. Present a detailed report as required reading for all staff and affiliates outlining the procedure for resolving commercial relationships that may present a conflict of interest. Include disclosure form submission process, how the ACCME defines a commercial interest, and the consequences of a failure to disclose relevant financial relationships.
4. Ensure that stakeholders can easily communicate with your organization about potential conflicts of interest. Use an advanced notification system in addition to email to be certain that each party is always up-to-date on organizational policies and decisions.
5. Keep track of email responsiveness and form submissions through a platform that allows you to identify and track program data and compliance issues (such as forms left unsubmitted) early.
Learn more about how to use an integrated data management and learning management system.
The ACCME on Commercial Independence: What You Should Know in 2019
- Standards for Commercial Support (webpage)
- ACCME Standards for Commercial Support (PDF)
- Accreditation Requirements (PDF)
Need a quick primer on commercial independence? Find out how the ACCME defines and regulates commercial independence for CME providers.
A Recent Update to Commercial Independence Standards
Now, if your spouse or partner is an employee or representative of a commercial interest, you may be considered to have a conflict of interest for the purposes of ACCME standards.
The ACCME is now planning to issue a further revised version of the Standards for Commercial Support in 2020:
“We expect to issue a revised version of the ACCME Standards for Commercial Support: Standards to Ensure Independence in CME Activities℠ (the Standards) for comment in early 2020.”
Finding the Right Technology Partner for Compliance
EthosCE makes documenting commercial independence easy with simple report generation and elegant templates that make creating commercial relationship notifications in reports and publications painless.
The EthosCE LMS also streamlines internal communications, making it easier to ensure that your entire staff has the same information and level of access to data.
We make it simple for CME CEs to develop a robust plan to address commercial independence issues. Want to watch us work? Click through for a free demo of our platform.
EthosCE believes CME technology solutions should be designed to improve healthcare professionals’ user experience, comply with ACCME guidelines, reduce administrative costs, and demonstrate measurable outcomes.
To learn how EthosCE can enhance the continuing education of your medical professionals, request a free 1-on-1 demo with one of our specialists today.