Regulatory Guidelines Meeting the New Guidelines and Grantor Needs: Adapt, Comply, or Die Brian P. Russell, R.Ph., M.B.A. President, Institute for Continuing Healthcare Education Medical education companies must change the way they do business to meet the new guidelines and grantor needs. Vox Medica Medical education companies must think beyond ACCME Standards for Commercial Support and FDA guidance if they are to understand what most concerns commercial funding sources in today’s environment: the Department of Health and Human Services’ Office of the Inspector General (OIG) Compliance Guidance. With their own internal compliance programs now in place, many major pharmaceutical and biotechnology companies have eliminated the influence of sales and marketing personnel from educational grant functions and established new processes, such as grant committees, to review and approve all requests for financial support of educational programs. Many companies now will accept educational grant requests only directly from accredited providers. As a result, medical education companies must change the way they do business to meet the new guidelines and grantor needs. Demonstrate Independence Wisely, most major commercial funding sources now insist on a clear, distinct, and well-documented separation of support for accredited educational activities from any form of promotional influence or activity. It is the responsibility of any educational organization, including medical education companies, to demonstrate and thoroughly document this independence. Ensure Transparency Providers should be able to clearly demonstrate that they understand the issues and have implemented policies and procedures, including an internal compliance program, in accordance with all current regulatory concerns: OIG Guidance, the Anti-Kickback Statute, the False Claims Act, and CME safe harbor, in addition to guidances issued by bodies such as the ACCME, PhRMA, and others. A good provider will be happy to open its files for review to any interested party. Be in Compliance, Really Policies and procedures must be applied consistently to all activities, regardless of the funding source or type of activity, for all educational initiatives. Such consistency of behavior protects the provider from suggestions of external influence and protects funding sources from suggestions of attempting to exert such influence. Think Outcomes Demonstrating positive patient outcomes is required of CME providers for accreditation and is increasingly expected by funding sources, which are, very appropriately, looking to outcomes measures to gauge the effectiveness of grant-supported programs in improving patient care. Measuring outcomes, based on a needs assessment, helps to mitigate risk for commercial supporters. Use Sound Evidence Providers need to make sure all programs are evidence-based, balanced, and unbiased, and needs assessments should be well-documented. Faculty should represent diverse points of view when appropriate. Content should be balanced and supported by appropriate evidential sources. Commercial funding sources should expect and encourage this level of performance, and target audiences should expect nothing less. Document Everything Providers must document full adherence to all policies and procedures. Clear demonstration that actions taken were based on the provider’s policies and procedures — not the funding source’s intent — mitigates risk by leaving few elements open to interpretation by others. Look Smart Providers should be able to demonstrate that they are fully aware of all regulatory guidances, their implications, and processes and procedures to mitigate risk in funding educational programs. And they should do this for all grant requests, in addition to showing that the program that is in need of funding is worth supporting. Businesses, including pharmaceutical and biotechnology companies are not philanthropic organizations. There are sound strategic reasons for them to support independent, accredited continuing-education activities for physicians and other healthcare practitioners. These reasons may be corporate, or they may be product-specific. But in today’s regulatory environment, this support must come with absolutely “no strings attached.” It is the responsibility of the provider to manage and execute high-value programs that mitigate risk and maximize compliance with regulatory guidelines for all funding sources, and it’s in the best interests of the provider, too. Vox Medica, Philadelphia, is an independent healthcare marketing communications company that includes three marketing groups: Health-Care Public Relations, Health-Care Marketing and Communications, and Health-Care Training and Development, as well as the independent Institute for Continuing Healthcare Education. For more information, visit voxmedica.com. August 2005 VIEW on Medical Education

Download PDF