Life Science Compliance Update

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August 06, 2013

Physician Payment Sunshine Act: CME Coalition’s Sunshine Act Compliance Guide for CME Providers and Supporters

The CME Coalition released a comprehensive guidebook to provide clear rules for participation in Sunshine-exempt Continuing Medical Education (CME) activities. We have written about the guidebook previously, along with our numerous Sunshine-related posts.

The CME Coalition's Sunshine Act Compliance Guide will: "provide clarity on the CME Sunshine exemption to medical education providers, CME event sponsors, commercial supporters and physicians."

A direct link to the Sunshine Act Compliance Guide can be found here and at http://www.cmecoalition.org/.

The Guide draws on legal guidance commissioned by the CME Coalition from the law firm Alston & Bird and discussions with CME providers and other outside council.

The CME Coalition anticipates: "further guidance outlining possible additions to the list of accrediting bodies that are counted towards meeting the Sunshine-exemption criteria outlined in the Act, as well as more details around the treatment of attendee meals. However, in advance of that guidance, there is still adequate information available to safely plan Sunshine-exempt CME programs."

Andrew Rosenberg, Senior Advisor to the CME Coalition stated: "We hope that this Compliance Guide will quickly become industry standard and are confident it will provide stakeholders with the necessary confidence to plan successful CME events without the burdens or penalties that are applicable to non-accredited activities."

The guide is broken down into several sections to help CME providers ensure compliance at all stages in the CME lifecycle. For example, the guide includes recommendations on how to plan CME programs during the grant or proposal phase, and what kind of information CME providers should include and exlucde in such proposals. The guide also provides in-depth recommendations about:

  • Reporting educational value associated with CME, such as slides or handouts;
  • Reporting payments under $10;
  • Meals to physician-attendees as well as speakers
  • Unaccredited or non-certified CME programs;
  • Payments made directly to teaching hospitals for CME;
  • Joint sponsorship of CME programs; and
  • Exhibit booths

The guide also includes a "compliance decision tree" that helps CME providers make simple and quick determinations about reporting meals and other items associated with CME programs for both speakers and attendees. Finally, the Guide includes frequently asked questions (FAQ) that affect CME providers and related stakeholders.

The CME Coalition represents a collection of continuing medical education provider companies, in addition to other supporters of CME and the vital role it plays in the US health care system. Its member organizations provide, manage and support the development of healthcare continuing education programs that impact more than 500,000 physicians, nurses and pharmacists annually.

The CME Coalition notes that: "graduation from medical school and completion of residency training are the first steps in a career-long educational process for physicians. To take advantage of the growing array of diagnostic and treatment options, physicians must continually update their technical knowledge and practice skills. CME is a mainstay for such learning."

In addition to the guide the CME Coalition will be posting a frequently asked questions from CME providers in the Sunshine Act resource center in the coming days.

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