Sunshine Act Requirements have Implications for Companies' Product-Oriented Activities, According to Report by Cutting Edge Information

RESEARCH TRIANGLE PARK, NC--(Marketwired - July 23, 2015) - With the passage of the Sunshine Act, companies may face challenges recruiting sufficient key opinion leaders (KOLs) to support their activities, according to a recent study published by fair market value (FMV) benchmarking firm Cutting Edge Information.

The study, Global Key Opinion Leader Compensation 2015, found that reporting obligations under the Sunshine Act may indirectly impact companies' drug safety activities, such as developing educational Risk Evaluation and Mitigation Strategies programs. If a company either selects or directly pays physicians for associated costs, it would report this investment - just as it would for non-accredited, continuing medical education speaker programs or advisory board panels. Granted, if payments exclusively cover materials that have FDA approval - such as medical information guides - companies need not report expenses.

Reporting requirements may also impact companies' publications activities as well. Generally, companies are responsible for defining outside parties' roles and tracking the extent these individuals contribute to the medical writing process. After coordinating with the Centers for Medicare & Medicaid Services, the International Society for Medical Publications Professionals (ISMPP) developed and released an informal guidance in August 2013: ISMPP Suggested Approaches for Sunshine Act Interpretation and Implementation for Publication Support Requirements.

This guidance urges companies to track their publications activities and provides best practices for compensating physicians for their services. By advising companies to research competitive rates and pay physicians on either an activity-by-activity basis or for the scope of the project, the resulting guidance highlights the importance of FMV data.

Global Key Opinion Leader Compensation 2015, available at http://www.cuttingedgeinfo.com/research/medical-affairs/thought-leader-fmv-physician-fee-schedules/, is designed to help drug and device companies stay compliant and keep pace with the rapid, worldwide formalization of FMV processes and legislation, as well as to determine whether company FMV payments for specialists and non-MDs are defensible and clear. Other key questions answered by this report include:

• What are the most relevant factors to consider when determining FMV compensation?
• How do subspecialists fit into the FMV determination process?
• What factors should companies take into account when formalizing their payments?
• How is the US Sunshine Act influencing transparency requirements in other markets?

To learn about Cutting Edge Information's fair market value service, please visit http://www.cuttingedgeinfo.com/physician-fair-market-value/.

Cutting Edge Information's FMVConnect Database

FMVConnect, a benchmarking and analysis solution by Cutting Edge Information, provides healthcare companies with the data necessary to build key opinion leader relationships and to establish top-notch physician and non-physician fair market value fee schedules.

Our team of research experts has worked with thought leaders and pharmaceutical executives to develop a time-tested methodology for identifying and segmenting healthcare professionals and for determining fair market value for specific thought leader activities.

With Cutting Edge Information's FMV services, you can:

• Implement a fee schedule based on detailed KOL compensation benchmarks
• Establish sound consultant and advisor payment practices
• Receive a customized data set based on your company's specific needs

FMV data for different thought leader activities are presented in tables and grouped by specialty, geographic region and tier. Our comprehensive database includes information from 117 countries, 109 specialties and subspecialties and 63 non-specialties.
Go to http://www.cuttingedgeinfo.com/physician-fair-market-value/ for more information.