1. CME Under Fire THOMAS SULLIVAN President Rockpointe Corporation March 6, 2009

2. Disclosure Rockpointe is a Science based Medical education company of 25 full time employees based in Columbia Maryland The Potomac Center for Medical Education is an ACCME accredited provider and receives financial grants from pharmaceutical and device manufactures I am committed to the free flow of ideas in CME and support the current ACCME Standards for Commercial Support™ Author of the website policy and medicine www.policymed.com

3. What is CME Continuing medical education is important for: – Everyone in the field of medicine – Maintenance of competency/ licensure/board certification and hospital privileges – Uptake and the free flow of new information and practices – Translation of 150,000 journal articles published each month

4. Certified CME: Education produced by an accredited CME provider (not easy process) Complies with ACCME and other accrediting bodies standards Complies with federal compliance FDA/OIG guidance Content and delivery are independent of supporter (commercial) influence Complies with the AMA definition of CME Does not pay for participation, expenses, travel

5. Promotional Programs – Non CME Events/Courses Promotional Education – Pharma or Device company directed – Must stay on FDA Label – Reviewed by FDA and HHS IG’s office – Can not be altered by speakers – Designed to familiarize HCP’s with approved Drugs/ Devices and approved indications

6. Financial Support for CME 50% from private and public sources (subscriptions and attendee fees) 50% from grants including industry support Grants Represent $1.2 Billion of support (2007) Little support from public health, insurance companies, hospitals/health systems, universities

7. Regulatory Stakeholders in CME FDA HHS IG Congress States Attorney Generals State Legislatures Corporate Integrity Agreement s PhRMA -- AdvaMed CMS ACCME AMA, AAFP, ACPE, ANCC, State medical boards

8. How is CME regulated Federal and ACCME rules require that accredited providers: – Ensure that content is evidence based – Conflicts of Interest Disclosed and Resolved Speakers, staff, writers…. – Independence of Provider – On-Site Audits – Public Disclosure of Accreditation Status

9. Physicians Choice CME agenda is controlled by medicine Physicians are not paid to attend CME Participation is voluntary Physicians evaluate for Bias Varied CME opportunities: associations, journals, internet, meetings Quality wins out

10. Points to Consider with CME Commercial and Public Interest are not incompatible No evidence that commercial bias is harmful or wide spread Changes accelerated over last four years No viable alternative to funding Changes in regulations can have profound effect on patient care especially in rural and inner-city areas.

11. Revised PPSA 2009 and CME Reporting Payments over a cumulative value of $100 dollars. Requires Reporting of: –Honoraria, Food, Travel, Education –Compensation for serving as a faculty member or as a speaker for a continuing medical education program –Grant –Any other nature of payment or other transfer of value as defined by the secretary Collection of Medicare Billing Number

12. PPSA 2009 Language (Direct Payments) Provides a payment or other transfer of value to covered recipient (or to an entity or individual at the request of or designated on behalf of a covered recipient) Question – Does this exempt reporting information on CME participants and faculty and if so how?

13. PPSA 2009 Compensation as a CME Faculty or Speaker Local CME Providers – Must provide “timely” information to supporter on speaker compensation, travel and incidental expenses – Manufacturers will be hesitant to give small grants Multi Supported Programs – Would you apply the full payment to the physician to each supporter. Drive away non-conflicted faculty

14. PPSA 2009 Collection of Medicare Billing Number For CME events and activities this could be considered a problem due to identity theft Physicians don’t know this number or readily give this out

15. PPSA 2009 Payment Application If the payment or other transfer of value is related to marketing, education, or research specific to a covered drug, device, biological, or medical supply, the name of that covered drug, device, biological, or medical supply. Question: CME is not brand or device specific, and the language directly references education what is this meant to capture?

16. PPSA 2009 Effect on Exhibits at National Meetings Reporting cumulative payments of $100 – Negative effect on convention business – Exhibits would have to keep track of Educational Items Distributed and Value Coffee/Tea stations at exhibits (would have to swipe your card for coffee) Will reduce overall traffic to exhibit (physicians hesitant from giving their information just because they visited an exhibit hall)

17. Changes to Report Physicians but not Manufactures can change report No resolution for physicians to change prior to the publishing of the report.

18. Pre-Emption No Pre-emption of additional requirements Without some type of true pre-emption, states will be able to pass additional restrictions (this could become a never ending process)

19. American Academy of Family Physicians Goals Minimizes the administrative burden that reporting requirements would place on physicians; Enables the physician to correct incorrect reporting data before the companies releases it for publication; and Ensures the reporting requirements do not have a chilling effect on efforts to educate physicians about research and new developments in diagnosis and treatment.

20. For More Information Thomas Sullivan, Rockpointe tsullivan@rockpointe.com www.policymed.com and www.rockpointe.com John Kamp, Coalition for Healthcare Communication www.cohealthcom.org jkamp@cohealthcom.org