Within the Patient Protection and Affordable Care Act [Section 6301 and Section 10602, Public Law 111-148], Congress created a Patient-Centered Outcomes Research Institute (PCORI). According to the legislation, the PCORI will act as a non-profit organization to assist patients, clinicians, purchasers, and policy-makers in making informed health decisions by carrying out research projects that provide quality, relevant evidence on how diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed.
Under this provision, the Comptroller General of the United States was required to appoint 19 members to the Board of Governors of the. The Act also provides that the Directors of the Agency for Healthcare Research and Quality (AHRQ) and the National Institutes of Health (NIH), or their designees, be members of the Board.
Last week, the Government Accountability Office (GAO) announced the 2010 appointments to the PCORI Board. Members of the Board appointed by Gene L. Dodaro, Acting Comptroller General, serve six-year terms and are eligible for reappointment for one subsequent six-year term. The terms of the PCORI Board members first appointed are staggered, with the appointments made in September 2010 set at two, four, and six year terms. Board members must meet the qualifications listed in the Affordable Care Act.
The Act also directs the Comptroller General to appoint not more than 15 members to a Methodology Committee of PCORI. A Federal Register notice calling for nominations to this Committee is expected to be issued by September 30th.
In making this announcement, Mr. Dodaro noted that, “The research to be developed by PCORI has the potential to improve the quality of health care for people across the nation.” Accordingly, he pointed to the “outstanding group of individuals” chosen, which bring “an impressive range of knowledge, expertise, and professional experience to this important initiative.” Short biographies of these individuals are located at the bottom of the GAO press release. Most of the members are in academia or non-profit organizations, with a few from the health care industry. Commissioners whose first term will expire in September 2016 are:
– Eugene Washington, MD, MSc, Vice Chancellor, UCLA Health Sciences, and Dean, David Geffen School of Medicine, University of California Los Angeles. Dr. Washington will serve as the chair of the PCORI Board of Governors.
– Steven Lipstein, MHA, President and Chief Executive Officer, BJC Health Care, a non-profit health care delivery system. Mr. Lipstein will serve as the vice chair of the PCORI Board of Governors.
– Christine Goertz, DC, PhD, Vice Chancellor for Research and Health Policy, Palmer College of Chiropractic and Palmer Center for Chiropractic Research.
– Sharon Levine, MD, Associate Executive Director for The Permanente Medical Group of Northern California, a large multi-specialty group practice within Kaiser Permanente’s integrated delivery system.
– Ellen Sigal, PhD, Chairperson and founder of Friends of Cancer Research, a cancer research think tank and advocacy organization.
– Harlan Weisman, MD, Chief Science and Technology Officer, Medical Devices and Diagnostics, for Johnson & Johnson.
– Robert Zwolak, MD, PhD, a vascular surgeon at Dartmouth-Hitchcock Medical Center and professor of surgery at the Dartmouth Medical School.
Commissioners whose first term will expire in September 2014 are:
– Lawrence Becker, Director, Strategic Partnerships and Alliances, Xerox Corporation.
– Arnold Epstein, MD, the John H. Foster Professor and Chair of the Department of Health Policy and Management at Harvard University School of Public Health, and practicing internist at Brigham and Women’s Hospital.
– Andrew Imparato, JD, President and Chief Executive Officer of the American Association of People with Disabilities.
– Robert Jesse, MD, PhD, Principal Deputy Under Secretary for Health and National Program Director for Cardiology, Department of Veterans Affairs.
– Freda Lewis-Hall, MD, Chief Medical Officer and Senior Vice President of the Pfizer Medical Division.
– Grayson Norquist, MD, MSPH, Professor and Chairman, Department of Psychiatry and Human Behavior, University of Mississippi Medical Center.
Commissioners whose first term will expire in September 2012 are:
– Debra Barksdale, PhD, RN, Associate Professor, University of North Carolina (UNC) at Chapel Hill School of Nursing.
– Kerry Barnett, JD, Executive Vice President of Corporate Services and Chief Legal Officer, The Regence Group.
– Allen Douma, MD, Chief Executive Officer of Empower, LLC, and a member of the AARP Board of Directors.
– Leah Hole-Curry, JD, Program Director for the Health Technology Assessment (HTA) program, Washington State Health Care Authority.
– Harlan Krumholz, MD, Harold H. Hines, Jr. Professor of Medicine and Epidemiology and Public Health at Yale University School of Medicine.
– Richard E. Kuntz, MD, Senior Vice President and Chief Scientific, Clinical, and Regulatory Officer of Medtronic, Inc.
The board includes representatives from academia, hospitals, patient organizations and industry. Overall the makeup represents a balanced panel.
Many United States based comparative effectiveness research is still in the early phases. Much of the current CE trials are retrospective Meta analysis’s and sample sizes vary by type of trial, and often don’t answer the question they are looking for. In the case of one example PCI vs. CABG in diabetic patients the comparative effectiveness trials brought on more questions than answers.
As the PCORI board begins on this endeavor, it is crucial that they do not blur the differences between scientific and policy debates. The PCORI must not discourage innovation in research, discovery, and development in new medicines and devices.
While it is important that we find effective treatments for physicians to use, the motivations of these decisions must be scientific, not policies designed only to save money.