Accredited CME Providers Restructure to Ensure Compliance

Case examples illustrate how ACCME worked with accredited providers to implement the redefinition of commercial interest
Chicago, IL
March 30, 2010

 

The Accreditation Council for Continuing Medical Education (ACCME) is providing an update and case examples to illustrate how its redefinition of commercial interest has been implemented.

In August 2007, the ACCME announced that it was expanding its definition of commercial interest in order to further safeguard CME’s independence. The redefinition states that a commercial interest is: "any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients." Entities that meet this definition are not eligible for ACCME accreditation and cannot act as joint sponsors (educational partners of accredited providers). Previously, the ACCME had defined commercial interests as "any proprietary entity producing health care goods or services consumed by, or used on, patients."

The ACCME broadened the definition in response to evolution in the CME environment. Some accredited providers have parent and/or sister companies or divisions that are involved in marketing, reselling or distributing health care goods or services — and because of that relationship the accredited provider could fall under the expanded definition of commercial interest, unless they took steps to restructure their organizations. The ACCME’s goal is to ensure that those accredited providers have effective safeguards in place to protect their independence and produce CME that promotes improvements in health care. All accredited providers must adhere to the ACCME Standards for Commercial SupportSM: Standards to Ensure Independence in CME Activities.

Implementing the Expanded Definition of Commercial Interest

When the redefinition was announced, all accredited providers were expected to examine their organizational structure to ascertain whether they, their parent or their sister organizations (if such relationships exist within their structure) would meet the modified definition of commercial interests. If so, they needed to restructure to remain eligible to be accredited. The ACCME allowed those providers a two-year grace period, until August 2009, to alter their organizational structure and separate their CME program from the commercial interest.

To assist providers, the ACCME published information on its Web site, including an example of a compliant corporate structure. The ACCME worked individually with accredited providers affected by the redefinition, answering questions and providing them with information so that they could make informed decisions about how to proceed. The ACCME also reviewed providers' proposed solutions before they were implemented, to help assure that the plans complied with ACCME requirements.

In 2008 and 2009, the ACCME reviewed 30 accredited providers that appeared to be affected by the change in the definition of a commercial interest, and found that 17 would be considered commercial interests. Of those, 14 successfully restructured and retained their accreditation; three did not restructure and withdrew from accreditation. As an additional safeguard, in August 2009, the ACCME asked all accredited providers to take a self-assessment to ensure they were not commercial interests.  This self assessment can also be used by accredited providers that are determining whether or not to work in joint sponsorship with a non-accredited entity.

For more information, see ACCME Policies — Commercial Support and Disclosure. For FAQs regarding the redefinition of commercial interests, visit Ask ACCME — Standards for Commercial Support, 1: Independence.

Case Examples

The ACCME offered several alternatives for corporate restructuring that would meet its requirements. Below is one example of a corporate structure that is ACCME-compliant and one description of structures that are not compliant.

Example #1: Successful Restructuring — Accredited Provider with Parent and Sister Companies

An accredited CME provider can have a sister corporation that is a commercial interest. The parent corporation cannot be a commercial interest, each corporation must be a separate legal entity and there must be proper firewalls in place.

An accredited provider restructured by setting up a parent corporation and two sister corporations. One sister corporation is a commercial interest (it markets, re-sells or distributes health care products or services); the other is an accredited CME provider. The parent corporation functions as a holding company comprising areas such as information technology, human resources and financial services. These services are shared by the sister corporations. Each corporation is a separate legal entity (LLC, Sub S or C Corporation).

This structure would be considered compliant because the CME provider

  • is not owned or controlled by a commercial interest,
  • has separate management,
  • is the employer of record,
  • has a governance structure separate from the governance structure of the commercial interest,
  • receives any funds from a commercial interest only as commercial support in accordance with the Standards for Commercial Support.

Separate staffing, physical location and secure information technology infrastructure that cannot be accessed by the sister corporation are additional features of independent organizations. The presence of written firewall policies, demonstrating that decisions concerning CME content are independent of the ACCME-defined commercial interest formalize the independence.

This approach to separation was adopted by a number of corporations with multiple divisions, including entities that engaged in advertising, marketing, and publishing in numerous fields in addition to health care.

Example #2: Unsuccessful Restructuring — Withdrawal from Accreditation

Some organizations were not able to ensure the independence of education from promotion and as a result withdrew from ACCME accreditation. In some cases, corporations were unwilling to convert divisions to separate legal entities. Some accredited providers were unable to clearly demonstrate that heir governance was independent of the parent and sister(s) corporations, that they had authority to manage planning and content independent of commercial interests. Some did not have written firewall policies. Some failed to clearly demonstrate separation of staffing, physical location or secure infrastructure (e-mail/servers). Given those findings, the ACCME determined that these organizations would not meet the ACCME’s expectations as articulated in the definition of a commercial interest.

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The Accreditation Council for Continuing Medical Education is a not-for-profit organization based in Chicago that is responsible for accrediting U.S. institutions that offer continuing medical education through a voluntary, self-regulatory system. The ACCME also has a system for recognizing state medical societies as accreditors for local organizations offering CME.

The ACCME's mission is to identify, develop and promote standards for quality continuing medical education that improves health care for patients and their communities. There are currently approximately 2,500 accredited CME providers in the United States, whose educational activities draw more than 17 million health care practitioner participants annually.

The ACCME's member organizations include the American Board of Medical Specialties, the American Hospital Association, the American Medical Association, the Association for Hospital Medical Education, the Association of American Medical Colleges, the Council of Medical Specialty Societies and the Federation of State Medical Boards of the U.S. Inc.

For more information, visit www.accme.org.

 

Contact Info: 
thosansky@accme.org