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FDA’s Hamburg, AHRQ’s Clancy, and Others Address Policy, Practice, Health Law, Informed Consent, and More

The term “patient-centeredness” is now enshrined in law by the Affordable Care Act, which created the new Patient Centered Outcomes Research Institute. Patient-centeredness is increasingly embedded in program developments at the federal and state level, and in the private sector, too. But what does patient-centeredness actually mean? What programs are working and how do we know? Will patient-centeredness have staying power? Is there a business case for patient-centeredness?

More than 30 distinguished speakers, including Margaret Hamburg, MD, Commissioner, FDA; Carolyn Clancy, MD, Director, Agency for Healthcare Research and Quality, Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health, FDA; Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA; Joe V. Selby, MD, MPH, Executive Director, Patient-Centered Outcomes Research Institute; and Karen Ignagni, President and CEO, America’s Health Insurance Plans, are convening  November 29-30, 2011, at FDA to discuss these issues and more at ECRI Institute’s 18th Annual Conference, Patient-Centeredness in Policy and Practice: A Conference on Evidence, Programs, and Implications. 

The program, cosponsored by the U.S. Food and Drug Administration, is a free public service and will be held onsite at FDA’s White Oak Campus in Silver Spring, MD, and web-streamed for those unable to travel. Advance registration is required.

“Concrete movements in the direction of patient-centeredness are visible in a number of areas, including the development and deployment of new technologies that must be regulated effectively and paid for appropriately,” says Jeffrey C. Lerner, PhD, President and CEO, ECRI Institute. “We’re also seeing closer relationships among clinicians and patients that include shared decision-making, the evolution of less-fragmented care delivery systems, and the application of health services research and regulatory science to stimulate and evaluate patient-centered approaches.” 

“The patient is the ultimate beneficiary of innovative medical technology,” says Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. "Patient experience can help FDA make better informed benefit-risk determinations."

The two-day program features eleven sessions that move progressively from theme to theme so that attendees who participate from the first through the last session will gain a coherent understanding of many of the most crucial elements in the movement towards patient centeredness.  Day 1 sessions cover researching and regulating for patient-centeredness; health law; patient-centeredness as a core medical skill; the use of evidence in patient-centered informed consent; quality measurement in building accountability; and  influencing consumer perception and behavior with advertising, social media, and behavioral economics. 

Day 2 sessions examine the use of technology in patient reporting; FDA’s perspective on the role that patients play in the life cycle of medical products; patient centeredness in health systems; federal and state models; and an important closing session on the business case for patient centeredness. 

“The agenda is designed with many question-and-answer periods that give attendees an unprecedented opportunity to participate in the deliberations, not just to listen to others speak,” adds Lerner.

The initial list of confirmed speakers includes:

• Annette Bar-Cohen, Executive Director, The Center for National Breast Cancer Coalition Advocacy and Training
• Christine Bechtel, Vice President, National Partnership for Women & Families
• Gregory Campbell, PhD, Director, Division of Biostatistics, US Food and Drug Administration
• Kristin Carman, PhD, Managing Director, Health Policy & Research, American Institutes for Research
• Carolyn M. Clancy, MD, Director, Agency for Healthcare Research and Quality
• Malcolm Cox, MD, Chief Academic Affiliations Officer, Veterans Health Administration
• Leah Hole-Curry, JD, Medical-Administrator, Department of Labor and Industries, Washington State;  Member, Patient Centered Outcomes Research Institute (PCORI)  Board of Governors
• Susan Dentzer, Editor-in-Chief, Health Affairs
• Kay Dickersin, PhD, Director, Center for Clinical Trials, Johns Hopkins Bloomberg School of Public Health
• Diane Dorman, Public Policy Vice President, National Organization for Rare Disorders
• Susan Edgman-Levitan, Executive Director, John D. Stoeckle Center for Primary Care Innovation, Massachusetts General Hospital, Boston
• Michael Fordis, MD, Director, Center for Collaborative and Interactive Technologies; Director, John M. Eisenberg Center for Clinical Decisions and Communications Science; and Senior Associate Dean for Continuing Medical Education, Baylor College of Medicine
• Daniel M. Fox, PhD, President Emeritus, Milbank Memorial Fund  
• Margaret A. Hamburg, MD, Commissioner, FDA
• Florence Haseltine, MD, PhD, Director, Center for Population Research, National Institutes of Health; Founder, Society for Women’s Health Research
• Eric Holmboe, MD, Chief Medical Officer, American Board of Internal Medicine
• Carmen Hooker-Odom, MRP, President, Milbank Memorial Fund
• David Hoyt, MD, FACS, Executive Director, American College of Surgeons
• Karen M. Ignagni, President and Chief Executive Officer, America’s Health Insurance Plans (AHIP)
• Craig Jones, MD, Director, Vermont Blueprint for Health, Department of Vermont Health Access
• Richard Kuntz, MD, MSc, Senior Vice President and Chief Scientific, Clinical and Regulatory Officer, Medtronic Inc.; Member, Patient-Centered Outcomes Research Institute  (PCORI) Board of Governors 
• Joel Kupersmith, MD, Chief Research and Development Officer, Veterans Health Administration
• Jeffrey C. Lerner, PhD, President and CEO, ECRI Institute
• Sharon Levine, MD, Associate Executive Director, The Permanente Medical Group, Inc.
• Ben Moulton, JD, MPH, Senior Legal Advisor, The Foundation for Informed Medical Decision Making
• Michael Park, JD, Counsel, Alston and Bird
• John B. Reiss, JD, PhD, Partner, Saul Ewing, LLP
• Amy Schwartz, Founder, IDEO Chicago’s User Research Group
• J. Sanford Schwartz, MD, Leon Hess Professor of Medicine, Health Care Management, and Economics, School of Medicine and the Wharton School, University of Pennsylvania
• Joe V. Selby, MD, MPH, Executive Director, Patient-Centered Outcomes Research Institute
• Karen Sepucha, PhD, Director, Health Decision Sciences Center, Massachusetts General Hospital; Assistant Professor, Harvard Medical School
• Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health (CDRH), FDA
• Dale Collins Vidal, MD, Dartmouth Hitchcock Medical Center
• Mary Weich-Brady, MSN, RN, Senior Policy Analyst, Center for Devices and Radiological Health, US Food and Drug Administration 
• Steven E. Weinberger, MD, FACP, Executive Vice-President, Chief Executive Officer, American College of Physicians
• Janet Woodcock, MD, Director, Center for Drug Evaluation and Research (CDER), FDA
• Additional speakers will be announced shortly

Senior leaders from the U.S. Agency for Healthcare Research and Quality, Health Affairs, Foundation for Informed Medical Decision Making, American Board of Internal Medicine, Kaiser Permanente Institute for Health Policy, the Milbank Memorial Fund, and the Leonard Davis Institute of Health Economics at the University of Pennsylvania played key roles in designing the program intended for multiple healthcare constituencies, including payers and providers, policymakers, researchers, industry, government, and consumer groups.

ECRI Institute is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Details on continuing medical education, nursing, and legal credits will be posted to the conference site.There is no fee to attend this program in person or via Webcast, but space is limited and early registration is strongly recommended. ECRI Institute will offer live updates from the event on Twitter.

Source: ECRI Institute