Continuing Education: Perspective from a Commercial Supporter Cathryn M. Clary, MD Vice President, US External Medical Affairs Pfizer Inc December 11, 2008 1
Disclosures: Cathryn Clary, MD n Full time employee and shareholder of Pfizer Inc n Pfizer Inc supports grants for independent Continuing Medical Education across multiple disease areas and clinical competency areas that cross disease states n The content in this presentation is my own 2
Topics n Changes in Industry Support for CME n How Does Industry Support CME? n Perspective on a Potential CE Institute 3
Evolving External Environment n 2002 PhRMA Code on Interaction with Health Care Professionals n 2003 OIG HHS Compliance Program Guide for Pharmaceutical Manufacturers n 2003 AdvaMed Code of Ethics on Interactions with HealthCare Professionals n 2004 ACCME Updated Standards for Commercial Support n 2004 Conjoint Committee CME Task Force Recommendations n 2006 ACCME Revised Accreditation Standards n 2007 Senate Finance Committee Report on Use of Educational Grants by Pharmaceutical Manufacturers n 2009 New PhRMA Code of Interaction with Health Care Professionals 4
Significant Changes in How Industry Supports CME Since OIG Guidance n CME grant making moved into Medical Affairs departments n Sales and marketing removed from grant decisions n Many companies operating under Corporate Integrity Agreements (CIAs) Warner Lambert Settlement in 2004 for $430M had False Claims Act CME component Recent settlements requiring separation of CME and promotional speakers n Significant focus on compliance with regulations Annual training of staff Internal and external auditing Continuous process improvement efforts to remove support for CME from promotion while still retaining value to corporation n Online posting of CE grants funded 5
Accelerating Pace of Scrutiny and Change 2008 Dec 2007 April 16th May June July/August u Macy Report: Continuing Education in the Health Professions u Recommends phasing out support for CME u Journal of the American Medical Association published editorial calling on professional organizations and CME providers not to condone or tolerate input from for-profit companies u Senator Grassley (R-IA) reintroduced Physician Payments Sunshine Act requiring public disclosure of gifts to physicians u Industry-supported CME is a form of payment u AMA House of Delegates refers back proposal by Committee on Ethical and Judicial Affairs to purge industry funding from CME u AAMC Task Force report on industry funding u ACCME Call for Comments: Should industry Support CME? u Senator Grassley inquiry of APA industry funding u Pfizer changes eligibility criteria for grant recipients Source: http://www.mmm.online.com/the-end-of-cme-as-we-know-it/ 6
Why Does Industry Continue to Support CME? Overlapping zones of mutual value Patient Needs Business Needs Ideal Area for Commercial Support Healthcare Provider Performance Gaps Healthcare System Quality Gaps 7
Concerns about Bias have led to Additional Changes in How Industry Evaluates and Supports CE n Increased funding for educational needs assessments n Increase in funding for: Performance improvement CME (increasingly understood by industry) Evidence based CME CME with good educational outcomes assessments Issue with all above: good grants sparse n Educational alignment with clinical interests of firm n Venue for learning Overly lavish venues, or programs with too little education are denied n Capabilities of provider n Single funding source vs multiple (latter preferred) 8
Potential Steps Industry Could Take to Further Manage COI n Increase transparency Disclosure of grant name, provide and amount industry standard Greater transparency about processes for grant reviews n Encourage Performance Improvement CME block grants Allows local providers ie AMCs, Medical Associations to target education where it is most needed Enhances impact of education n Consider organizational COI issues in grant approval % dependence on company funding; consider only funding grants with multiple funders Patient-centric degree of parent mission alignment n In AMCs, approve grants only through central CME office CME office control and delegation of authority n Provide Grants to Educate Providers and Physicians about COI issues in CME 9
New Medical Education Grant Policy Pfizer 2008 n To only support providers most likely to meet the highest standards of quality and independence defined by the medical profession Direct funding support towards duty of care providers i.e. AMCs, medical associations n To support the profession s move towards performanceimprovement initiatives that integrate education and quality Initiate a competitive grant review period for grant applicants to encourage more innovative, high-quality grant applications (2009) Review all major grants using criteria equivalent to ACCME s highest level of accreditation Redirect resources closer to the point of care in order to better meet the needs of the new model of PI-CME n To support the medical community s call for balanced funding in CME by establishing organizational or grant dependency financial caps on commercial support 10
How Might an Institute Facilitate Commercial Support of Performance Improvement CME? n We would strongly support formation of such an institute n Strong need for better understanding of what educational methods work, for which learners, in what context n Research generated would presumably increase quality of grants Enable us to approve more grants that would enhance quality of care Direct our spending for greater impact Improve ability of providers to innovate n Would enhance training of CE personnel throughout the field; internal to industry as well as on provider side Ultimate endpoint: Better CE producing better care for patients 11