The Case: Arnie Acme, EdD, the newly hired senior educational strategist for the Society Against Depression (SAD), is reviewing the organization’s employee handbook as part of his orientation. Based on his years of experience in a variety of accredited-provider organizations, he is pleased with the society’s policies on commercial support and joint sponsorship, but is surprised to learn that SAD has no formal CME compliance program and no procedures for investigating noncompliance and arbitrating disputes.
How should compliance concerns be handled?
Overstreet: In this era of increased scrutiny and transparency, with increasing surveillance and newspapers running stories about noncompliance, providers need clearly defined processes and lines of communication. All of us should be careful to adhere to our own policies as well as those of the regulatory and accrediting agencies. And we should ensure that CME-related tasks, such as collaborating with educational partners, are coordinated by appropriately trained and experienced individuals.
The months roll by before Arnie learns that SAD’s meeting planner, Angie Amapra, has committed the society to jointly sponsor several independent nonaccredited education companies’ educational symposia. She also agreed that the companies can submit grant requests and accept funds on behalf of the society. Arnie recognizes that this is clearly a violation of the society’s policies, but he is puzzled about how to handle the situation without defined procedures.
Parochka: Arnie has a clear opportunity to demonstrate his leadership skills. He can quickly organize educational sessions to review the Standards for Commercial Support and joint sponsorship. This would allow him to update SAD’s staff without insulting his colleagues, while still showing the organization that it is out of compliance. And he could talk with his manager about creating processes for monitoring compliance and the benefits of an ongoing training program.
Is a formal compliance program required?
Overstreet: While providers are not currently required to have an official compliance program, the Code of Conduct for Commercially Supported CME recently endorsed by the North American Association of Medical Education and Communication Companies strongly encourages both providers and supporters to comply with the seven elements of a compliance program as defined by the OIG: having written policies and procedures; designating a compliance officer and/or committee; conducting effective staff training; developing effective lines of communication, including an anonymous reporting function; conducting internal monitoring and auditing; enforcing standards through well-publicized disciplinary guidelines; and responding promptly to detected problems and undertaking corrective action. And according to the most recently published profile of medical education companies*, 76 percent have implemented a formal compliance program and 10 percent are planning to do so. It might be wise for Arnie and his team to determine the level of and commitment to compliance—with the society’s policies as well as national ones—of all of his potential joint sponsors.
Parochka: Regulations should be no surprise to CME staff members. Professional CME organizations should seize this opportunity to bond together and promote compliance. Providers should issue clear and easy-to-follow codes and procedures and share them so that CME professionals can be united around common goals and values.
What can you do about another provider’s noncompliance?
Parochka: Everyone knows whistleblowers have been rewarded with hefty payments. Get over it!! We are in an environment where cellphones take pictures and send text messages that can be shared with colleagues in a nanosecond, and none of us is immune to having someone misinterpret our intentions. My advice is to put yourself in the other provider’s shoes and ask how you would like to be treated. Take the high road. Pick up the phone and call the provider’s CME director. Ask her if she is aware of the noncompliant situation and provide a “heads up” if she is not. Asking questions and acting as a facilitator will go a long way toward improving professional relationships.
Karen Overstreet, EdD, RPh, FACME, CCMEP, is president, Indicia Medical Education LLC, North Wales, Pa. Reach her at Karen.Overstreet@indiciaed.com
Jacqueline Parochka, EdD, FACME, is president and CEO, Excellence in Continuing Education Ltd., Gurnee,
Ill; and partner, PTR Educational Consultants.Reach her at JacquelineParochka@comcast.net.
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