Adapting to Meet the New Guidelines and Clients’ Needs Compliance Heidi L. Liston, Pharm.D. Senior VP and General Manager DiMedix To ensure success in today’s environment, MECs will need to invest to meet the requirements of set guidelines and standards and remain flexible to change. To adapt to the new guidelines and meet their clients’ needs, medical education companies (MECs) must first recognize the many different types of clients they support in producing effective continuing medical-education (CME) programs. These groups — grantors, accredited providers, academic institutions, professional associations, government agencies, expert faculty, and ultimately the healthcare audience — form the MEC’s network of clients. Fostering solid relationships with these groups provides the foundation on which compliant educational programming is developed. Compliance at the Core At the core of every successful MEC is an internal compliance administration with sound knowledge and understanding of the guidelines to ensure the company adheres to the industry standards. The internal compliance administration also is responsible for training and ongoing quality improvement for everyone employed by the MEC. In addition, MECs will need to be appropriately organized and structured to ensure compliance with guidelines and regulations. Group holding companies must be able to demonstrate strict firewalls among their subsidiary companies that work on continuing professional education and promotional education, respectively. Separation includes all facets, from scientific support to accounting. Investing the Resources for Compliance To ensure success in today’s environment, MECs will need to invest to meet the requirements of set guidelines and standards and remain flexible to change. In this new era of securing grant funding from pharmaceutical companies for CME, there is often no or limited interaction with medical experts from within companies, as more pharmaceutical companies move to an online grant submission process. Historically, MECs relied on feedback from pharmaceutical companies for direction on the identified need for medical-education funding. MECs now must be willing to invest time and expertise to research and understand the educational needs of healthcare providers; to develop innovative learning modalities; and to determine the needs of potential grantors. Through these investments, MECs will be better equipped to align the educational needs of practitioners with potential grantors to secure grant funding. MECs with solid scientific expertise will form alliances with expert faculty, academic institutions, professional organizations, and government agencies to enhance needs analyses that lead to learning initiatives that respond to healthcare providers’ unmet educational requirements. In addition, adopting proficient measurements for educational outcomes will determine the effectiveness of programs on changing behaviors to improve patient health and assist with future educational planning. Measuring educational outcomes is becoming imperative as changes in Medicare Part D and pay-for-performance programs are implemented. The government, as the greatest funding agency for healthcare, will be looking for educational solutions that ensure physician proficiency. Cost-Effectiveness is Critical Pharmaceutical company educational grant divisions are under increasing scrutiny not only to ensure compliance but to make certain available grant dollars are used appropriately. This is especially important as available funding becomes harder to get. MECs must find cost-effective methods to deliver quality educational programming to greater numbers of healthcare providers. While most healthcare providers prefer live CME activities, there is increasing use of Web-based learning options by practitioners. Staying abreast of adult-learning trends is important, especially to expand reach to those most in need of education and to realize cost savings through enduring programs. DiMedix, Warren, N.J., offers innovative products, services, and audience-generation solutions that impact the dissemination of scientific information to physicians and allied health professionals. For more information, visit dimedix.com. To ensure success in today’s environment, MECs will need to invest to meet the requirements of set guidelines and standards and remain flexible to change. August 2006 VIEW on Medical Education Compliance

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