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CME Under Fire THOMAS SULLIVAN President Rockpointe Corporation March 6, 2009 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 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 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 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 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 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 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 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 • • • • • 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. 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 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? 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 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 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? 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) Changes to Report • Physicians but not Manufactures can change report • No resolution for physicians to change prior to the publishing of the report. 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) 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. For More Information • Thomas Sullivan, Rockpointe [email protected] www.policymed.com and www.rockpointe.com • John Kamp, Coalition for Healthcare Communication www.cohealthcom.org [email protected]