ACCME Standards for Integrity: Update at a Glance

See the updated ACCME Standards for Integrity and Independence in this free eBook!

You’ll learn:


  • Get the latest news on ACCME commercial support standards.
  • Find answers to the most-asked questions with these new updates.
  • See details on how the ACCME is battling commercial bias in CE.

  • Get a quick rundown in what you need to know about conflict of interest.
  • See the new standards around funding.
  • Learn about new CME provider responsibilities and more!

Excerpt

Stream, clarify, and modernize. New structural revisions. New terminology. What do these words mean for you?

The new ACCME Standards for Integrity and Independence in Accredited Continuing Education. were drafted to make accredited continuing education serve the needs of patients and the public. Learning materials are based on validated content and are free from any kind of commercial influence from ineligible companies.

As of December 10, 2020, the former ACCME Standards for Commercial Support have been replaced to reflect these updated, streamlined, and modernized Standards. After this time of transition, as an accredited provider, you’ll be expected to comply with the new requirements by January 1, 2022. 

In this ebook, we provide you with a breakdown of all the changes in the Standards in detail, if they affect you, and what you need to know and do.

A Who’s Who of the Eligible and Ineligible

There is a vast difference between ACCME System organizations that are considered to be eligible and those that are not. Your organization must show that you provide direct clinical services or education of healthcare professionals or serve as a fiduciary to patients, the public, a population’s health, or any other organization that is otherwise ineligible. These eligible organizations include:

  • Ambulatory procedure centers
  • Blood banks
  • Diagnostic labs that do not sell proprietary products
  • Electronic health records companies
  • Government or military agencies
  • Group medical practices
  • Health law firms
  • Hospitals or healthcare delivery systems
  • Infusion centers
  • Insurance or managed care systems
  • Nursing homes
  • Pharmacies that do not manufacture proprietary compounds
  • Publishing or education companies
  • Rehabilitation centers
  • Schools of medicine or health science universities
  • Software or game developers

Ineligible companies cannot become ACCME accredited because their primary business is to produce, market, sell, resell, and/or distribute healthcare products. These include:

  • Advertising, marketing, or communications firms whose clients are ineligible companies
  • Biomedical startups that have begun a governmental regulatory approval process
  • Compounding pharmacies that manufacture proprietary compounds
  • Device manufacturers or distributors
  • Diagnostic labs that sell proprietary products
  • Growers, distributors, sellers, or manufacturers of medical foods and dietary supplements
  • Manufacturers of health-related wearable products
  • Pharmaceutical companies or distributors
  • Pharmacy benefit managers
  • Reagent manufacturers or sellers 

The Five ACCME Standards for Integrity and Independence in Accredited Continuing Education

The ACCME oversees the Standards for Integrity and Independence in Accredited Continuing Education. They were designed to apply to accredited continuing education across health professions in order to better reflect their scope and extent. The Standards:

  • Ensure that accredited continuing education serves the needs of patients and the public.
  • Provide learners with only accurate, balanced, and scientifically justified recommendations.
  • Assure healthcare professionals and teams that they can trust accredited continuing education to help them deliver safe, effective, cost-effective, and compassionate care that is based on best practices and best proactive evidence.
  • Create a clear, unbridgeable separation between accredited continuing education, marketing, and sales.

Let’s look at each of the five ACCME Standards in greater detail.

Standard 1: Ensure That Content Is Valid

Comprising several areas, Standard 1 applies to all accredited continuing education. Here’s what you need to know.

As an accredited provider, your organization is responsible for ensuring that your education is both fair and balanced and that all your clinical content supports safe and effective patient care.

Your accredited continuing education must be based on current science and evidence and clinical reasoning. There must be balanced views of diagnostic and therapeutic options.

In addition, you must conform to a number of generally accepted standards of experimental design, data collection, analysis, and interpretation related to all scientific research that is referred to, reported, or used in accredited education in support or justification of patient care recommendations.

Next, areas such as the discussion, debate, and exploration of new and evolving opportunities need to be clearly identified within your program and individual presentations. The accredited providers have to facilitate involvement with these topics without advocating for or promoting practices that are not yet adequately based on science, evidence, and clinical reasoning.

Finally, your organization cannot be accredited if you advocate for unscientific approaches to diagnosis and therapy or if your education promotes recommendations, treatment, or manners of practicing healthcare that are determined to have risks or dangers that outweigh the benefits or are known to be ineffective in the treatment of patients.

Standard 2: Prevent Commercial Bias and Marketing in Accredited Continuing Education

Standard 2 applies to all accredited continuing education. Here’s what to take on board as you prepare to make the year-long transition.

Your accredited continuing education must protect your learners from any commercial bias and marketing. As an accredited provider, you must make sure all decisions related to your planning, faculty selection, delivery, and evaluation of accredited education are made with no influence or involvement from the owners and employees of an ineligible company.

Next, your accredited education must be free of marketing or sales of products or services. Your faculty must not actively promote or sell products or services that serve your professional or financial interests during the accredited continuing education.

Finally, as an accredited provider, you must not share the names or contact information of your learners with any ineligible company or its agents without their explicit consent.

Standard 3: Identify, Mitigate, and Disclose Relevant Financial Relationships

Standard 3 applies to all continuing education. Here’s what you need to know.

While healthcare professionals may have financial relationships with companies that are ineligible, the relationships cannot be allowed to influence accredited continuing education. So as an accredited provider, you must identify any relevant financial relationships between individuals who are in control of educational content and ineligible companies. You have to manage these to ensure that there is no commercial bias brought into the education. Financial relationships of any dollar amount are defined as relevant if the educational content is related to the products or services of the ineligible company.

You also have several critical steps that you must follow when developing your educational content.

  • Collect information: You must collect information from all faculty, planners, and others who control educational content about all their financial relationships in the past twenty-four months. The disclosure must include the name of the ineligible company involved and the nature of the financial relationship, such as an employee, researcher, speaker-contracted researchers, patent or royalty beneficiaries, or ownership in the areas of individual stocks and stock options. Diversified mutual funds do not need to be disclosed.
  • Exclude any owners or employees of ineligible companies from controlling content: Owners or employees of ineligible companies must be excluded from controlling content or participating as planners or faculty in accredited education. However, there are three exceptions to this rule. Employees of ineligible companies can participate as planners or faculty in these specific situations:
    • If the content is not related to products, business lines, or services of their employer or company
    • If the content is limited to basic scientific research, like pre-clinical research, drug discovery, or research methodologies (but care recommendations must not be made)
    • If technicians are demonstrating safe and proper uses of items like medical devices (but they cannot recommend whether or when a device is used)
  • Identify relevant financial relationships: You must review the information that you gather to determine which relationships are relevant. Financial relationships are relevant if the educational content controlled by the individual with the relationship is related to products, business lines, or services of the ineligible company.
  • Mitigate relevant financial information: You must take steps to prevent everyone who has financial relationships from adding commercial bias into your content.
  • Mitigate relationships prior to individuals assuming their roles: For example, you must take steps for individuals based on their specific roles, e.g., faculty would have different steps than those of planners, which would take place before planning begins.
  • Document the steps taken to mitigate relevant financial relationships: You should also document the steps that you took to mitigate any financial relationships.
  • Disclose all relevant financial relationships to your learners: Your learners will receive disclosure information regarding the names of individuals with relevant financial relationships, as well as the names of the ineligible companies that they are associated with and the nature of those relationships. They will also receive the statement that all relevant financial relationships have been mitigated.
  • Identify ineligible companies by their names only: You must not disclose ineligible companies’ names, corporate or product logos, trade names, or product group messages.
  • Disclose absence of relevant financial relationships: You must inform your learners about continuing education planners, faculty, and any others in control of content with no relevant financial relationships with ineligible companies.

Finally, your learners must also receive disclosure information that is in a format that can be verified at the time of accreditation prior to engaging with the accredited continuing education. The exceptions include non-clinical accredited education, learner group-controlled content, and self-directed learning, whereby the learners control their educational goals and report on the changes that resulted.

Standard 4: Manage Commercial Support Appropriately

Standard 4 addresses the accredited continuing education that receives financial or in-kind support from ineligible companies. How does this affect you?

If you are an accredited provider that accepts commercial support from ineligible companies, you are responsible for ensuring that your education remains independent of the ineligible company. This support cannot result in any form of commercial bias or influence in the continuing education.

Decision-making and disbursement: As an accredited provider, you must make all decisions about your receipt and disbursement of the commercial support. In addition, the ineligible companies that you deal with must not directly pay for any expenses incurred from the learners’ education. However, you can use commercial support for honoraria funding or travel expenses for individuals or groups of individuals in accredited education. You can also use any commercial support in order to defray or eliminate education costs for learners. You must document all terms, conditions, and purposes into an agreement with your accredited organization and the ineligible company.

Accountability: You must keep a record of the amount or type of commercial support that you are receiving and how it was used. From there, you must produce that accounting upon request by the accrediting body or the ineligible company that provided the commercial support.

Disclosure to learners: Learners must receive disclosure regarding the name(s) of the ineligible company(ies) that provided commercial support and the nature of the support. This disclosure cannot include corporate or product logos, trade names, or product group messages.

Standard 5: Manage Ancillary Activities Offered in Conjunction with Accredited Continuing Education

In the final Standard for Integrity and Independence in Accredited Continuing Education, we see that Standard 5 applies only when there is marketing by ineligible companies or non-accredited continuing education. What does this mean for you? 

First, accredited providers are responsible for making sure that their learners’ education is separate from marketing by ineligible companies (this includes all advertising, exhibits, sales, and promotions) and from non-accredited education that is offered in conjunction with accredited continuing education. This includes making arrangements to allow ineligible companies to market or exhibit in association with accredited education.

Second, your arrangements with ineligible companies must not influence any decisions related to the planning, delivery, and evaluation of the continuing education or interfere with education presentations. Learners will need to have the ability to easily distinguish between an accredited education and other activities.

Furthermore, for any marketing, exhibits, or non-accredited education developed by ineligible companies, planners, or faculty who have unmitigated financial relationships, there are now new requirements. Their activities must not occur within the same space as accredited educational activities in the thirty minutes before or after that activity. If there are activities that are part of the event but are not accredited for continuing education, these have to be clearly labeled and communicated as such.

When it comes to print, online, or digital continuing education activities, your learners cannot be presented with marketing messages while they are taking part in the accredited education activity. They must be able to click through without having to listen, watch, or be presented with product promotions.

Additionally, any educational materials, like slides, handouts, abstracts, or evaluations, must not contain any marketing content produced by an ineligible company, including logos, trade names, or product messages.

On the other hand and as an exception, information about accredited education that does not include educational content—like schedules or logistical information—can include marketing by or for an ineligible company. 

Finally, these companies may not provide access to or distribute accredited education to learners.

The Current Adopters

Six accrediting bodies representing multiple health professions have adopted these newly evolved Standards for Integrity and Independence in Accredited Continuing Education to reflect the values of the continuing education community. 

  • Accreditation Council for Continuing Medical Education (ACCME)
  • Accreditation Council for Pharmacy Education (ACPE)
  • American Academy of Family Physicians (AAFP)
  • American Nurses Credentialing Center (ANCC)
  • Association of Regulatory Boards of Optometry’s Council on Optometric Practitioner Education (ARBO/COPE)
  • Joint Accreditation for Interprofessional Continuing Education™

Summing It Up

As a continuing education provider, you must comply with the new ACCME Standards. Let’s revisit all five.

Standard 1: Ensure That Content Is Valid

Content validity for patient care must be based on current science, evidence, and clinical reasoning. Likewise, accredited continuing education is where discussions, debates, and the explorations of new and upcoming topics take place. This Standard goes on to state that continuing education must not advocate practices that are not yet based on the current science, evidence, and clinical reasoning.

Standard 2: Prevent Commercial Bias and Marketing in Accredited Continuing Education

As an accredited continuing education provider, you must protect your learners from commercial bias and marketing exposure. Your decisions related to planning, faculty selection, course delivery, and the evaluation of accredited education must be made with no influence from the owners or employees of ineligible companies.

Also, be aware that your faculty must not actively promote products or services that benefit their professional or financial interests during the accredited continuing education.

When planning your continuing education activities, you must not share the name or contact details of your learners with any ineligible company or its representatives without their explicit consent.

Standard 3: Identify, Mitigate, and Disclose Relevant Financial Relationships

You will collect information from all individuals about their financial relationships with ineligible companies within the past twenty-four months. The disclosed information must include the names of any ineligible companies that the person has a relationship with and the nature of the financial relationship.

You will exclude any owners of ineligible companies in order to identify those who are owners or employees of these companies. However, there are three exceptions to this: 1) when the activity content isn’t related to the business lines or products of the company or employer; 2) when the accredited activity’s content is limited to areas such as pre-clinical research, drug discovery, or research methodologies and the company doesn’t provide care recommendations; or 3) when the company is participating as a technician that teaches safe and proper uses of medical devices and does not makes recommendations on the device’s use.

You also have to mitigate relevant financial relationships, taking steps to prevent these individuals from placing commercial bias into content. You will perform this mitigation before these individuals commence their roles. Also, bear in mind that mitigation steps will be different for faculty than for planners.

Standard 4: Manage Commercial Support Appropriately

If you choose to accept commercial support, you are responsible for ensuring that education stays independent of the ineligible company. That support cannot result in commercial bias in your continuing education.

Standard 5: Manage Ancillary Activities Offered in Conjunction with Accredited Continuing Education

You need to ensure that your education is separate from any ineligible company marketing, such as advertising, sales, promotions, and exhibits. You must make sure your learners can distinguish between their accredited education and other activities. Any live continuing education activities can’t occur in the accredited educational space within thirty minutes before or after an accredited educational activity. You also have to ensure that any print, online, or digital continuing education activities, such as abstracts, slides, evaluation mechanisms, or disclosure information, do not contain marketing messaging from ineligible companies. 

When Do These Changes Affect You?

Since December 10, 2020, the former ACCME Standards for Commercial Support have been replaced to reflect these updated, streamlined, and modernized Standards. After this time of transition, as an accredited provider, you’ll be expected to comply with the new requirements by January 1, 2022. 

This transition phase applies to providers that are ACCME-accredited, state-accredited, or jointly accredited. If you are accredited by other accrediting bodies that have adopted the Standards, you should contact their accreditor for information about your timeline.

Enduring Materials: What Do You Need to Know and Do?

ACCME advises you to begin the transition now when it comes to your enduring materials, especially for activities that start in 2021 and will continue to be available in 2022. If you have activities that were planned or released before 2021, ACCME does not expect you to make changes to or obtain new disclosure information from any individuals who were in control of the content.

You should also take note that your activities are subject to the Content Validity of Enduring Materials policy. You need to ensure that your content is up to date and is accurate at least every three years or more frequently if the content requires review.

Tools Available to Help

To help you make the transition to the Standards for Integrity and Independence in Accredited Continuing Education, ACCME offers a complete downloadable toolkit in a fillable PDF format that contains sample letters, worksheets, and other tools. 

In addition, you can download other tools with the same PDF-fillable format:

Conclusion

These new Standards for Integrity and Independence in Accredited Continuing Education are intended to provide learners with accurate and evidence-based information that enables better, safer, and more effective patient care. The Standards work to identify eligible and ineligible companies to determine who can and cannot be accredited or control continuing education content for those activities, making the process a successful one for learners and providers alike.
At EthosCE, we understand the challenges of staying up to date and compliant with ACCME changes. We know how critical it is to get things done right the first time when it comes to team-based education and success.

To learn how EthosCE can enhance the continuing education of your healthcare teams, schedule a free 1-on-1 demo with one of our specialists today!

 

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