Life Science Compliance Update

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October 25, 2013

CME Joint Sponsorship Requires Significant Cooperation

As continuing medical education (CME) stakeholders began addressing concerns from commercial supporters about reporting requirements under the Physician Payments Sunshine Act, one area may need particular attention: joint sponsorship.

We previously noted that the Centers for Medicare & Medicaid Services (CMS) finalized in a Frequently Asked Question (FAQ) that the list of five (5) accrediting bodies is exhaustive. Thus, payments to speakers at CME events that are not run by CME providers accredited or certified by one of these entities are reportable payments or other transfers of value for Open Payments.

Consequently, several CME stakeholders have expressed concern about this limitation. Others have suggested that entities not recognized by one of these five bodies jointly sponsor CME programs.

Interestingly, a recent article from Medical Meetings reminds stakeholders considering joint sponsorship to be cautious, even though such collaborations can be productive and help CME providers avoid the burdens of the Sunshine Act.

Specifically, the authors noted that CME providers need to ensure that "joint sponsors—and others who can control or influence content—are not commercial interests (CI)." The ACCME does not prescribe how to determine eligibility for joint sponsorship; providers have to select and implement their eligibility-determination method based on their risk tolerance, and knowledge of and comfort level with potential partners, along with other factors.

Some require a signed attestation that the entity is independent from CIs. Reviewing the potential partner's Web site and marketing materials also may shed some light on its business model, the authors note.

In addition, the article points out that the National Association of Medical Education Companies and the Society for Academic CME developed an attestation form that could be used to determine whether a medical education company fit the definition of a CI. However, the form did not require proof of a company's structure.

Accordingly, the authors suggest that accredited providers require potential joint sponsors to have their administrative structure reviewed by the ACCME. " Having a copy of ACCME's response in the activity files would go a long way toward documenting an educational partner's eligibility," they note.

Further, "If joint sponsors balk at the cost of the ACCME review, providers might consider requiring that content be peer-reviewed independently before certifying jointly sponsored activities for credit. (The joint sponsor would need to be forewarned that allocation of credit may be denied based on the peer-review findings.)"

In addition, the ACCME notes on their Joint Sponsorship Page that "special requirements exist for accredited providers that jointly sponsor activities with nonaccredited organizations that have a history of joint-sponsoring activities that do not comply with ACCME's content validation policies or policies for disclosure and commercial support." See Maintaining Compliance: ACCME Monitoring for additional information.

These considerations are particularly important even though the CME industry is facing funding challenges. For example, a recent webinar available on YouTube discussed the implications of increasing compliance restrictions on funding for CME/CPD, the effects of the global economic crisis, and other potential future challenges on CME funding are great.

Consequently, one important resource was recently published to address funding and other increased compliance challenges. Specifically, an international nonprofit dedicated to the advancement of global medical education, the Rome CME-CPD Group has developed the Red Book for Medical Meetings, a comprehensive guide for medical meeting planners on the regulations of sponsorship for medical meetings and CME/CPD accreditation systems around the world. The book offers an international compendium of pharmaceutical regulations, CME/CPD requirements, and industry regulations that are broken down on a country-by-country basis.

 

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