As pharmaceutical companies continue to change their granting policies and procedures to stay focused on quality improvement initiatives, many CME stakeholders want to know how these changing models are impacting patient care, physician behavior and stakeholder relationships. What is the effect of these funding models on partnerships between supporters and providers? These issues are particularly prominent in light of the Sunshine Act and other government requirements affecting public reporting and quality measures.
Early next fall, CBI will be hosting its 10th Annual Forum on Educational Grants. The title of this year’s event is “Ensure Compliant Funding & Evaluate Quality Improvement for Medical Education Programs. The program, which will be held in Philadelphia, Pennsylvania, on September 11-12, 2012, is led by CME experts from supporter and provider organizations. The annual event will discuss the challenges surrounding commercial support for medical education programs and provides a forum to discuss how to overcome those challenges and maintain compliance in the funding of outcomes-driven educational programs. Some of the distinguished speakers include:
– Thomas Sullivan, President, Rockpointe
– Jan Price, Director, Medical Education and Investigational Studies, U.S. Medical Affairs, Bayer HealthCare
– John Ruggiero Ph.D., MPA, CCMEP, Group Manager, Oncology, Genentech
– Frank Skopowski, Senior Director, Global Academic and Professional Affairs – Grant Operations, Merck & Co., Inc.
– Emily A. Miles CCMEP, Publications and Grants Associate, U.S. Medical Communications, Actelion Pharmaceuticals
– Laura Muttini RPh, MBA, CCMEP, Associate Director, Proprietary Products Division – U.S. Grant Management Department, Abbott Laboratories
Topics include:
- Examination of transparency measures and compliant reporting of grant funding under the Physician Payment Sunshine Act
- Evaluation of the changing CME environment and granting policies
- The integration of FDA-mandated REMS and continuing education initiatives
- How to monitor and audit CME programs through needs assessment
- The grant submission and review process
- Outcomes measurement and reporting
Below are some of the topics and panels in greater detail.
CME and Sunshine
With the implementation of the Sunshine Act in January 2012, many pharma companies are increasingly concerned about how the new public reporting guidelines will ultimately affect CME. The guidelines released by CMS are rather vague, using broad terminology such as “applicable manufacturer” and “covered recipient.” If a CME organization receives an educational grant from an applicable manufacturer and uses any portion of the payment toward a covered recipient (i.e. physician or teaching hospital), the manufacturer is responsible for reporting that payment. What are the pros and cons of this regulation, how are pharma companies dealing with the uncertainties
surrounding this law and how does the regulation affect both supporters and providers?
– How should supporters and providers navigate and interpret the guidance?
– What do the ambiguous terms actually mean?
– What resources are being used to meet government requirements?
– How will healthcare reform affect funding for CME?
– What other quality measures is the federal government looking at?
CME and REMS
For the first time ever, the FDA issued a REMS around long-acting and extended release opioids that required certified continuing education as part of its plan. While considered by many to be a positive move, this presented many challenges for the manufacturers and CE community alike. This session provides an update on the opioid REMS and also evaluates the potential role of certified CE in support of other REMS programs.
– Review lessons to be learned from the Industry Working Group (IWG) on meeting FDA’s expectations for certified CE in support of opioid REMS
– Explore how to align goals of REMS with educational needs
– Identify if, when and how certified CE can be integrated into any REMS program
How to Promote CME to Government, Public
As CME activities continue to receive scrutiny from the government and other stakeholders, how can companies justify their CME budget? If these educational initiatives are accomplishing positive results, how can this information be made known? How can the perceived improvement outcomes be disseminated? This panel describes how to raise the profile of CME impact with the public and the government, discusses how to advocate for CME internally and explains best practices for extending the life of important medical information through publication.
– Discuss the process of getting material published and identifying appropriate journals for your data
– Get outcomes data in front of government agencies and the general public
– Make use of outcomes data to validate CME spend inside pharma
Industry’s Role in Outcomes
As pharma works to take a bigger role in moving outcomes forward, how can pharma companies help to move providers up the outcomes continuum by requesting them to submit grant requests for high level educational outcomes? How can there be more consistent and open communication between providers and supporters? This panel discussion brings together representatives from Pfizer, GSK, Abbott and Astellas to discuss pharma’s elevated role in outcomes measurement and to address the changing granting models.