ACCMERulesStandardEligibility

Rule

Eligibility

  • Standard

Table of contents

About the Rule

The ACCME is committed to ensuring that accredited continuing education (1) presents learners with only accurate, balanced, scientifically justified recommendations, and (2) protects learners from promotion, marketing, and commercial bias. To that end, the ACCME has established the following guidance on the types of organizations that may be eligible to be accredited in the ACCME System. The ACCME, in its sole discretion, determines which organizations are awarded ACCME accreditation.

Types of Organizations That May Be Accredited in the ACCME System

Organizations eligible to be accredited in the ACCME System (eligible organizations) are those whose mission and function are: (1) providing clinical services directly to patients; or (2) the education of healthcare professionals; or (3) serving as fiduciary to patients, the public, or population health; and other organizations that are not otherwise ineligible. Examples of such 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
  • Health profession membership organizations
  • Hospitals or healthcare delivery systems
  • Infusion centers
  • Insurance or managed care companies
  • 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

Types of Organizations That Cannot Be Accredited in the ACCME System

Companies that are ineligible to be accredited in the ACCME System (ineligible companies) are those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Examples of such organizations include:

  • Advertising, marketing, or communication firms whose clients are ineligible companies
  • Bio-medical 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, manufacturers or sellers of medical foods and dietary supplements
  • Manufacturers of health-related wearable products
  • Pharmaceutical companies or distributors
  • Pharmacy benefit managers
  • Reagent manufacturers or sellers

Owners and Employees of Ineligible Companies

The owners and employees of ineligible companies are considered to have unresolvable financial relationships and must be excluded from participating as planners or faculty, and must not be allowed to influence or control any aspect of the planning, delivery, or evaluation of accredited continuing education, except in the limited circumstances outlined in Standard 3.2.

Owners and employees are individuals who have a legal duty to act in the company’s best interests. Owners are defined as individuals who have an ownership interest in a company, except for stockholders of publicly traded companies, or holders of shares through a pension or mutual fund. Employees are defined as individuals hired to work for another person or business (the employer) for compensation and who are subject to the employer’s direction as to the details of how to perform the job.

Ineligible companies are prohibited from engaging in joint providership with accredited providers. Joint providership enables accredited providers to work with nonaccredited eligible organizations to deliver accredited education.

The ACCME determines eligibility for accreditation based on the characteristics of the organization seeking accreditation and, if applicable, any parent company. Subsidiaries of an ineligible parent company cannot be accredited regardless of steps taken to firewall the subsidiaries. If an eligible parent company has an ineligible subsidiary, the owners and employees of the ineligible subsidiary must be excluded from accredited continuing education except in the limited circumstances outlined in Standard 3.2.

Key Concepts and Definitions

Key Concept: Structured Self-Assessment Related to ACCME’s Definition of an Ineligible Company

The ACCME provides a set of self-assessment questions that can help an organization determine whether it falls under the definition of an ineligible company. These questions are listed below:

  1. Does your organization, or a part of your organization, produce, market, sell, re-sell, or distribute healthcare products used by or on patients?
  2. Does your organization advocate for, or on behalf of, an ineligible company?
  3. Does your organization develop, or assist in the development of, non-accredited education in collaboration/partnership with ineligible companies?
  4. Does your organization have a parent company (a separate legal entity that owns or fiscally controls an organization) that:
    • produces, markets, sells, re-sells, or distributes healthcare products used by or on patients, and/or…
    • advocates for, or on behalf of, an ineligible company?
    • develops, or assists in the development of, non-accredited education in collaboration/partnership with ineligible companies?
  5. Does your organization have a sister company (a separate legal entity which is a subsidiary of the same parent company that owns or fiscally controls an organization) that:
    • produces, markets, sells, re-sells, or distributes healthcare products used by or on patients, and/or…
    • advocates for, or on behalf of, ineligible companies?
      develops, or assists in the development of, non-accredited education in collaboration/partnership with ineligible companies?

If Yes to 5:

  1. Does your organization share management, employees, or governance structure with the sister company?
  2. Are any owners, employees, or agents of the sister company involved in the planning, development, or implementation of educational content?
  3. Does the sister company control or influence, in whole or in part, the operations of your organization?

If your organization answers yes to any of these questions, it would likely be defined by ACCME as an ineligible company. If after answering these questions your organization still has questions regarding its status, you may wish to request that the ACCME conduct a corporate structure review.

An organization may contact the ACCME directly at info@accme.org to request that ACCME perform a corporate structure review. There is a $4,000 fee for a corporate structure review.

Definition: Ineligible Company

ACCME has incorporated eligibility information directly into the Standards for Integrity and Independence in Accredited Continuing Education. Companies that are ineligible to be accredited in the ACCME System (ineligible companies) are those whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients. Examples of such organizations include:

  • Advertising, marketing, or communication firms whose clients are ineligible companies
  • Bio-medical 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, manufacturers or sellers of medical foods and dietary supplements
  • Manufacturers of health-related wearable products
  • Pharmaceutical companies or distributors
  • Pharmacy benefit managers
  • Reagent manufacturers or sellers

Key Concept: Biomedical Startup Companies and Ineligibility

As described in the Standards’ section on eligibility, a biomedical startup is considered an ineligible company if it has begun a governmental regulatory approval process. For this requirement, the term “governmental regulatory approval process” applies to United States federal regulatory activities or equivalent regulatory processes outside of the US. There are several paths to regulatory approval, depending on the product being developed by the startup company. These are some examples:

  1. Prescription drugs and biologics: before a compound can be made available for clinical trials, it must be approved by the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) through an Investigational New Drug (IND) application. A startup is eligible until the company submits an IND application.
  2. Medical devices, including in-vitro diagnostics: a startup is eligible until it initiates a Premarket Submission process with the FDA, such as a Premarket Notification 510(k). Premarket Approval (PMA), a De Novo Classification Request, etc.
  3. Over the counter (OTC) drugs: a startup is eligible until it submits an application or Over-the-Counter (OTC) Drug Review (OTC drug monograph) to the FDA.

ACCME encourages providers to become more familiar with the overall FDA regulatory design for each class of product, as the above is only a brief summary and may not apply in every case. Resources to better understand each of these market entry processes can be found at the FDA website.