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August 25, 2014

Physician Payments Sunshine Act: ACCME Responds to CMS' Proposal to Remove CME Exemption

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The Accreditation Council for Continuing Medical Education (ACCME) has sent a letter to CMS urging them to reconsider their proposal to remove Section 403.904(g)(1), the CME exemption, from the Sunshine Act. The ACCME joins a long list of commenters who believe that indirect commercial support to an accredited CME vendor, which may be used to pay physician speaker fees, should be exempt from reporting requirements. The ACCME comment holds added importance because their Standards of Commercial Support is the model policy for ensuring complete separation between promotion and education. Furthermore, ACCME’s enforcement powers provide a great amount of “teeth” to ensure companies follow their Standards.

The ACCME believes that CMS should retain two of the requirements for accredited CME currently listed in Section 403.904(g)(1):

  • The applicable manufacturer does not pay the covered recipient speaker directly.
  • The applicable manufacturer does not select the covered recipient speaker or provide the third party (such as a continuing education vendor) with a distinct, identifiable set of individuals to be considered as speakers for the continuing education program.

“These requirements are essential elements” of the ACCME’s Standards for Commercial Support (SCS) states ACCME President and CEO Murrary Kopelow. “Under the Standards, commercial interests are not allowed to pay speakers directly nor are they allowed to suggest or select speakers. In addition, the Standards safeguard independence by requiring the identification and resolution of conflict of interest; the appropriate management of funds derived from industry; the absolute separation of promotion from education; the freedom from commercial bias; and the full disclosure of relevant financial relationships, as well as of any commercial support."

Two-Step Process for Exemption

In its letter to CMS, the ACCME puts forth a two-step process for CME learners, planners, and teachers and authors in commercially supported accredited continuing professional education to be exempt from reporting in Open Payments.

  • (1) The accreditation system must utilize the ACCME SCS exactly as written by the ACCME, and
  • (2) The accreditation system must successfully complete an ACCME verification process to “ensure that it evaluates its continuing education providers for compliance with the ACCME SCS using the same rules, data sources, and interpretations as the ACCME.”

“We believe this would establish a valid mechanism to a) retain a list of accreditation systems in which the ACCME SCS are implemented, as is currently the case in the regulations of the Open Payments program, and b) provide verification of this implementation using already existing processes within the system of professional self-regulation in accredited continuing education,” states Kopelow.

The ACCME states that “[b]y using the Standards for Commercial Support verification process as the mechanism for ensuring independence, CMS would leverage the long-established system of professional self-regulation in continuing education. Since 1987, the ACCME has administered an oversight system for other CE accreditors. This ACCME verification system includes 42 US state and territorial medical societies, the Accreditation Council for Pharmacy Education (ACPE), and the Joint Accreditation for Interprofessional EducationTM  program created in partnership by the ACCME, the ACPE, and the American Nurses Credentialing Center (ANCC).”

Murray Kopelow notes that many bodies already base their accreditation, activity approval, and credit system requirements on the ACCME SCS, including:

  • American Academy of Family Physicians
  • American Academy of Physician Assistants
  • American Dental Association
  • American Medical Association
  • American Nursing Credentialing Center
  • American Osteopathic Association
  • Association of Regulatory Boars of Optometry

We also would point out that the Council on Optometric Practitioner Education (COPE), the Accreditation Council for Pharmacy Education (ACPE), the American College of Obstetricians and Gynecologists (ACOG), and several others have either identical or very similar policies to the ACCME SCS.

“Verification could be a next step in order to ensure unity in requirements and interpretation,” states Kopelow. He also notes that “ACCME understands the enormity of the concession that each of the above organizations would be making if an ACCME SCS verification process became a requirement for exclusion under the Open Payments program. This service is not intended to impinge on the rights, responsibilities, or autonomy of continuing education accreditation and credit bodies or to imply any judgment on the integrity of their systems.” Kopelow states in the letter that ACCME is offering the verification service to CMS to “facilitate the appropriate exclusion of accredited continuing education from reporting under the Open Payments program."

“We propose to offer a service to the healthcare professions of the US—and the people that we all serve—that we believe will facilitate health professionals’ engagement in valid, practice-based, independent continuing education that has been shown, unequivocally, to improve their abilities and performance-in-practice in the healthcare system."

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