Expert Views
Learn how these experts define CER
Louis Jacques, MD, joined CMS in 2003 and has been director of the Division of Items and Devices in the Coverage and Analysis Group since 2004. The division reviews evidence and develops Medicare coverage policy for Part B drugs and biologicals, medical imaging and durable medical equipment. Prior to his arrival at CMS, Dr. Jacques was the Associate Dean for Curriculum at Georgetown University School of Medicine, where he retains a faculty appointment. He served on a number of university committees including the Executive Faculty, Committee on Admissions and the Institutional Review Board. He previously worked in the Palliative Care program at Georgetown’s Lombardi Cancer Center where he covered the gynecologic oncology service and he made home visits as a volunteer physician for a rural hospice on the Maryland Eastern Shore.
Following graduation from Georgetown University in 1978, he entered the University of Maryland School of Medicine, graduating in 1982. He completed residency in 1985 and was National Health Service Corps assignee to Peoples Community Health Clinic in Waterloo Iowa for four years. From 1989 to 1995 he saw primary care patients while also holding a variety of administrative and academic positions at Henry Ford Health Systems and Wayne State University School of Medicine in Detroit. His research interests and publications focused on injury prevention, physician workforce issues, and medical education.
"I think CATT showed the value of public investment in an important research questions that was probably not going to be addressed in the private sector"
The discussion presented represents the views of Dr. Louis Jacques MD, and does not necessarily represent the views of CMS or the United States government. No statement should be construed as an official position of CMS.
Hon. Tony Coelho, is a former United States congressman from California, and primary author and sponsor of the Americans with Disabilities Act.In March 2009, Coelho was named as Chairperson for the Partnership to Improve Patient Care (PIPC). In this capacity, Coelho will work to amplify the voice of the partnership’s diverse members, including people with disabilities, racial and ethnic communities and the elderly, among others. Coelho also serves as board Chairman of the America Association of People with Disabilities (AAPD), the country’s largest cross-disability membership organization.
Coelho was elected to Congress in 1978 and served for six terms until 1989. He served on the Agriculture, Interior, Veterans Affairs, and Administration Committees during his tenure, specializing in disabled rights. In 1986, Coelho was elected House Majority Whip. As the chief vote counter for his party, Coelho oversaw a series of Democratic victories in the House on measures ranging from the budget to cutting off funds for the war in Central America.
Coelho was the original author of the Americans with Disabilities Act, signed into law by President George H.W. Bush. By 1994, the U.S. Census Bureau reported that some 800,000 more people with severe disabilities had found employment than were employed when the bill was first enacted. The promise of Coelho’s political career had been redeemed by the disabled community from whose ranks he had arisen.
President Bill Clinton appointed Coelho to serve as Chairman of the President’s Committee on Employment of People with Disabilities, a position he held from 1994 to 2001. He also served as Vice Chair of the National Task Force on Employment of Adults with Disabilities. In 1998, Clinton appointed Coelho as the United States Commissioner General at the 1998 World Expo in Portugal. Clinton also appointed Coelho as Co-Chair to the U.S. Census Monitoring Board, a position he held until his appointment as general chairman of the Gore presidential campaign.
Coelho now makes his home in Rehoboth Beach, DE. He participates annually at New York Law School for its Tony Coelho Lecture in Disability Employment Law & Policy. He has endowed a chair in Public Policy at the University of California in Merced and also in Neurology for Pediatric Surgery at UCLA. In addition to currently chairing Life Without Limits and the Disability Pride & Power Committee, he serves on the Epilepsy Foundation Board of Directors.
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Kalipso Chalkidou, MD, PhD, is the director of the policy consulting arm of NICE (National Institute for Health and Clinical Excellence), responsible for managing and developing consulting services for international clients drawing on the Institute’s experience of using evidence to inform health policy and practice. Between 2007 and 2008, she spent a year in the US as a Harkness fellow in health policy and practice, studying conditional coverage (Centre for Medical Technology Policy, San Francisco) and drug pricing policies (Department of Health Policy and Management, Johns Hopkins School of Public Health, Baltimore). She holds a doctorate on the molecular biology of prostate cancer from the University of Newcastle upon Tyne (2003).“The question is not whether you have perfectly personalized information, or whether you have less perfectly personalized information. The question is really whether you have some information or have no information. Right now, the alternative to CER is basically having very little or no information."
Kevin Frick, PhD, MA, is a health economist who has been on the faculty of the Johns Hopkins Bloomberg School of Public Health for nearly 15 years. He is a professor in the Department of Health Policy and Management. He has taught about and performed cost-effectiveness research and other research comparing costs and outcomes of care or interventions for most of his career.He has taught in the School of Nursing at the Johns Hopkins University both as a guest lecturer and as the instructor running most of the health economics and finance course for the Doctor of Nursing Practice Students. The lecture he is asked to give most commonly is an overview of economics and cost-effectiveness analysis. He has participated in a number of research projects with colleagues at the School of Nursing—each of which has focused on measuring costs related to interventions that are being led by nurse researchers.
In addition to his work with the Johns Hopkins University School of Nursing, he has lectured at the Schools of Nursing at Loyola University of Chicago, at Columbia University, at the University of Maryland, at Pace University, and at the Univeristy of Indiana. He has presented plenary sessions at the Southern Nursing Research Society, at the NDNQI Meeting, and at several other nursing meetings. He has completed four years of service on the National Institute for Nursing Research Advisory Council. Prior to his membership on the Council and once while he has been on the Council he has helped to organize workshops on cost-effectiveness for nurse researchers.
His focus on cost-effectiveness and comparative effectiveness in nursing and in eye care demonstrates his clear interest in this area.
James Goodwin, PhD, is the Head of Research in Age UK, the new organization which resulted from the merger of Age Concern England and Help the Aged. The mission of Age UK is to improve the lives of older people.He holds a visiting professorship at Loughborough University in the Department of Human Sciences.
He is a member of the editorial board of the journal ‘Quality in Aging’ in the UK. He sits on numerous expert bodies, including the UN Research Agenda for Aging panel, the UN Digital Health Group, a WHO Advisory Group, scientific advisory panels of the research councils and is Chair of the Halcyon Knowledge Transfer Steering Committee at UCL. He is a member of a Ministerial Advisory Group on Dementia Research for the UK Government.
Professor Goodwin graduated with a bachelor’s degree in Biology from Keele University, UK. After graduation he read for a Master’s in Human Physiology at Loughborough University and then for a PhD in climatic physiology at the Postgraduate Medical School, University of Exeter. His research area was the effects of temperature variations on the autonomic cardiovascular responses of older people, an area highly relevant to the issue of climate change and older people’s health. His other area of expertise is knowledge transfer, sitting on the advisory Board of KT-EQUAL, as a panel member of the LLHW Program and as an adviser to Imperial College on their age-related research in the Faculty of Engineering.
Chris Henshall, PhD, is the Chair of the Health Technology Assessment international (HTAi) Policy Forum for the period of 2010 to 2013, and is an Associate Professor in the Health Economics Research Group at Brunel University and an Honorary Fellow in the Centre for Health Economics at the University of York in the UK. He is also a member of the Alberta Research and Innovation Authority in Canada. He was HTAi's founding President as well as the first Chair of the Policy Forum (2005 - 2007). Dr. Henshall held the position of Pro-Vice-Chancellor for External Relations at the University of York from January 2005 to April 2010. Prior to this, he had been Director of the Science and Engineering Base Group in the Office of Science and Technology in the Department of Trade and Industry in London, where he was responsible for around £3b (US $5b) per annum of government support for research and innovation. Before joining the Department of Trade and Industry, Dr. Henshall served as Deputy Director or Research and Development in the Department of Health. During his tenure there, he was closely involved in establishing the NHS HTA Program, the National Institute for Clinical Excellence, and, with colleagues in other countries, INAHTA. Over the years, he has also been involved in various initiatives to promote and co-ordinate HTA across Europe.
William W. Li, MD, President, Medical Director, and Co-founder of the Angiogenesis Foundation, has been changing the face of modern Medicine for 25 years, by tackling a "common denominator" of disease called angiogenesis, or new blood vessel growth. Trained by research pioneer Dr. Judah Folkman, Dr. Li is leading national and international efforts to bring forth revolutionary new treatments for cancer, diabetes, blindness, and heart disease that restore the body's normal balance of blood vessels. Through the Foundation, he has created a unique model for speeding medical advances by driving collaborations between scientists, clinicians, industry, regulators, payers, and patients. A major current focus of Dr. Li is aligning the goals of medical innovation and comparative effectiveness research and emerging health policy.A native of Pittsburgh, Dr. Li received his undergraduate degree from Harvard College, and his medical degree from the University of Pittsburgh School of Medicine. He completed his clinical training in Internal Medicine at the Massachusetts General Hospital in Boston. Dr. Li has served on the faculties of Harvard Medical School, and Tufts University School of Veterinary Medicine, and is currently a Visiting Assistant Professor of Medicine at Dartmouth Medical School. His work has been published in Science, The New England Journal of Medicine, The Lancet, and other leading peer-reviewed journals. Dr. Li has been a speaker at the TED Conference, and is a member of the Clinton Global Initiative.
Maureen G. Maguire, PhD, received her doctoral degree from the Department of Biostatistics, Johns Hopkins Bloomberg School Public Health and then joined the faculty of the Department of Ophthalmology, School of Medicine, Johns Hopkins University. Dr. Maguire served in increasingly more responsible positions (protocol monitor, biostatistician, senior biostatistician, deputy director, director) in as series of multicenter clinical trains in ophthalmology that were based either in the School of Medicine or School of Public Health. During this period, she also collaborated on multiple clinical research projects with colleagues in the Department of Ophthalmology and in teaching research methods with colleagues in the Welch Center for Prevention, a joint venture of the Schools of Medicine and Public Health.In July 1994, Dr. Maguire joined the faculty of the University of Pennsylvania to establish the Center for Preventive Ophthalmology and Biostatistics (CPOB). Since then, she has held leadership positions in several multicenter clinical trials for the prevention and treatment of age-related macular degeneration sponsored by industry and the NIH, including the ongoing CATT trial. In addition, she was actively involved in the development of the Vision In Preschoolers Study, an NEI-sponsored, multicenter, clinical investigation of methods for screening young children for vision problems.
Dr. Maguire is now the Carolyn F. Jones Professor of Ophthalmology and Vice Chair for Clinical Research in the Department of Ophthalmology. She has served on and chaired several data and safety monitoring committees and is on the editorial board of the journal Ophthalmology and Cornea. She has more than 125 publications in the areas of ophthalmology and clinical research.
Barbara McLaughlan, is the Policy & Campaigns Manager at the Royal National Institute of Blind People(RNIB). At RNIB, McLaughlan has played a major role in the successful campaign to ensure that patients with wet age-related macular degeneration are given treatment with new anti-VEGF treatments on the NHS. Access to treatment remains a major focus of her work as well as running several eye health promotion projects. Ms. McLaughlan is also the Chair of Patients involved in NICE (PIN), an independent group made up of patient and voluntary organizations that work closely with NICE. "From a patient’s perspective, if I were the patient I would always say ‘I want the licensed treatment because that’s gone through all the trials and I can be absolutely sure about what I’m getting, plus there is monitoring of outcomes and possible adverse events following licensing and use in clinical practice.’ So from a patient’s perspective it’s always better to get licensed treatments."
Dan Ollendorf, MPH, ARM, is Chief Review Officer for the Institute of Clinical and Economic Review (ICER); in this capacity, he is responsible for the conduct of systematic reviews of the comparative effectiveness of new or emerging health care technologies, as well as the coordination and oversight of the broader health technology assessment process. Dan’s 25 years of health care experience include work in the insurance, managed care, hospital, informatics, and consulting sectors, the last 15 years of which have been spent conducting health-economic, epidemiologic, and other relevant evaluations for a variety of stakeholders.
Prior to joining ICER, Dan was Executive Director, Health Economics and Outcomes Research, for IMS Health, where he was responsible for the operations and strategy of a $20 million franchise as well as the successful acquisition and integration of a US consulting practice. Dan has also served as Vice President of Applied Research at PharMetrics (now a unit of IMS), where he managed the scientific team conducting a variety of research initiatives using integrated claims data; and as a senior consultant at Policy Analysis Inc. (PAI), where he was responsible for the conduct and design of numerous health-economic, quality-of-life, and retrospective database analyses in a variety of therapeutic areas.
Dan holds a Master’s of Public Health in epidemiology/biostatistics and health services from Boston University, an Associate’s degree in Risk Management from the Insurance Institute, and a Bachelor of Arts in Health Administration from the University of Rochester. He has authored over 40 peer-reviewed articles, is a reviewer for several medical-scientific journals, and currently serves on the editorial advisory board of the Journal of Managed Care Pharmacy.
Alexander Ommaya, DSc, MA, is Director of Translational Research at the Department of Veterans Affairs. In this role he is responsible for managing development of new research activities focusing on health systems improvements, genomic medicine, text analysis of the VA electronic health record, comparative effectiveness research, traumatic brain injury, and Post Traumatic Stress disorder. Previously he was Director of the Institute of Medicine’s Drug Forum and Clinical Research Roundtable. These multi stakeholder groups addressed science policy issues concerning the research enterprise and established public / private collaborative research activities.At Blue Cross and Blue Shield of Florida he directed Business Knowledge Management where his department evaluated and developed improvements for pharmacy, disease, and utilization management programs. Dr. Ommaya has worked for the Agency for Healthcare Research and Quality as a Senior Advisor for the Office of the Administrator; Walter Reed Army Medical Center as a Senior Analyst for the Defense and Veteran’s Brain Injury Program; the U.S. Senate as a Health Policy Fellow; and the National Institutes of Mental Health. His previous research focused on neuroplasticity and cortical reorganization; treatment of malignant Glioma; rehabilitation after traumatic brain injury; and health care quality and costs of care. Dr. Ommaya is a member of the Veterans Affairs Technology Assessment Advisory Group and previously the Medicare Coverage Advisory Committee. Dr. Ommaya received his Doctoral degree in Health Policy and Management from Johns Hopkins University; a Master’s degree in Biopsychology from Mount Holyoke College; and his undergraduate degree in Philosophy from Vassar College.
The discussion presented represents the views of Alexander Ommaya, D.Sc., MA, and does not necessarily represent the views of the Department of Veterans Affairs or the United States government. No statement should be construed as an official position of the Department of Veterans Affairs.
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Sean Tunis, MD, MSc, is the Founder and Director of the Center for Medical Technology Policy in Baltimore, Maryland. CMTP’s main objective is to improve the quality and relevance of clinical research by providing a neutral forum for collaboration among experts, stakeholders and decision makers. Dr. Tunis was a member of the Institute of Medicine Committee on Initial National Priorities for Comparative Effectiveness Research. He advises a wide range of domestic and international public and private health care organizations on issues of comparative effectiveness, evidence based medicine, clinical research, reimbursement and health technology policy.
Through September of 2005, Dr. Tunis was the Director of the Office of Clinical Standards and Quality and Chief Medical Officer at the Centers for Medicare and Medicaid Services (CMS). In this role, he had lead responsibility for clinical policy and quality for the Medicare and Medicaid programs, which provide health coverage to over 100 million US citizens. Dr. Tunis supervised the development of national coverage policies, quality standards for Medicare and Medicaid providers; quality measurement and public reporting initiatives, and the Quality Improvement Organization program. As Chief Medical Officer, Dr. Tunis served as the senior advisor to the CMS Administrator on clinical and scientific policy. He also co-chaired the CMS Council on Technology and Innovation.
Dr. Tunis joined CMS in 2000 as the Director of the Coverage and Analysis Group. Before joining CMS, Dr. Tunis was a senior research scientist with the Technology Assessment Group, where his focus was on the design and implementation of prospective comparative effectiveness trials and clinical registries. Dr. Tunis also served as the Director of the Health Program at the Congressional Office of Technology Assessment and as a health policy advisor to the U.S. Senate Committee on Labor and Human Resources, where he participated in policy development regarding pharmaceutical and device regulation.
He received a B.S. degree in Biology and History of Science from the Cornell University School of Agriculture, and a medical degree and masters in Health Services Research from the Stanford University School of Medicine. Dr. Tunis did his residency training at UCLA and the University of Maryland in Emergency Medicine and Internal Medicine. He is board certified in Internal Medicine and holds adjunct faculty appointments at Johns Hopkins, Stanford and the University of California San Francisco Schools of Medicine.
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David O. Meltzer MD, PhD, is Chief of the Section of Hospital Medicine, Director of the Center for Health and the Social Sciences, and Chair of the Committee on Clinical and Translational Science at The University of Chicago, where he is Associate Professor in the Department of Medicine, Department of Economics and the Harris School of Public Policy Studies. Meltzer’s research explores problems in health economics and public policy with a focus on the theoretical foundations of medical cost-effectiveness analysis and the cost and quality of hospital care. Meltzer is completing a randomized trial comparing the use of doctors who specialize in inpatient care (“hospitalists”) with traditional physicians in six academic medical centers and is Director of the AHRQ-funded Hospital Medicine and Economics Center for Education and Research in Therapeutics (CERT) at the University of Chicago.
Meltzer received his MD and PhD in economics from the University of Chicago and completed his residency in internal medicine at Brigham and Women’s Hospital in Boston. Meltzer is the recipient of numerous awards, including the Lee Lusted Prize of the Society for Medical Decision Making, the Health Care Research Award of the National Institute for Health Care Management, and the Eugene Garfield Award from Research America. Meltzer is a research associate of the National Bureau of Economic Research, elected member of the American Society for Clinical Investigation, and past president of the Society for Medical Decision Making. He has served on panels examining the future of Medicare for the National Academy of Social Insurance and the Department of Health and Human Services (DHHS) and U.S. organ allocation policy for the Institute of Medicine (IOM). He is currently serving on an IOM panel on the Learning Health Care System, the DHHS Secretary’s Advisory Committee on Healthy People 2020,and the Patient Centered Outcomes Research Institute Methodology Committee, as a Council Member of the National Institute for General Medical Studies, and as a health economics advisor for the Congressional Budget Office.
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Cynthia Bens is the Director of Public Policy at the not-for-profit Alliance for Aging Research in Washington, DC. In this capacity, Ms. Bens is responsible for guiding the organization’s federal policy work, representing the Alliance in multiple national coalitions, and directing the Accelerate Cure/Treatments for Alzheimer’s Disease (ACT-AD) Coalition.
For the past eleven years Ms. Bens has worked to inform federal policymakers and educate the public on a variety of issues. For more than half of that time her efforts have centered on the formulation of policies to expedite the development of interventions to treat and prevent many debilitating age-related disease; to remove access barriers to needed treatments and therapies; and to improve the coordination and quality of care seniors receive.
Prior to joining the Alliance in 2006, Ms. Bens was a senior manager of government affairs with the Loeffler Group. As part of its federal government affairs practice, she represented diverse client interests before the U.S. Congress and the administration. Her core areas of focus included appropriations, budget, health care, education, telecommunications, and international trade. Through various other positions on Capitol Hill and in the private sector, she has acquired extensive experience researching and analyzing federal legislation and regulations. Ms. Bens holds a Bachelor’s of Arts degree from New York University with concentrations in Political Science and Women’s Studies.
"However, if {CER} results are poorly communicated, the availability of more information could lead to confusion for patients on what choices are the right ones for them and also confusion for providers on how they should treat their patients."
Prior to heading NAC, Ms. Hunt was President of her own aging services consulting firm for 14 years. She conducted corporate eldercare research for the National Institute on Aging and the Social Security Administration, developed training for caregivers with AARP and the American Occupational Therapy Association, and designed a corporate eldercare program for EAPs with the Employee Assistance Professional Association.
She was appointed by the White House to serve on the Policy Committee for the 2005 White House Conference on Aging. Ms. Hunt was on the Advisory Panel on Medicare Education, is chair of the National Center on Senior Transportation, is a Commissioner of the Center for Aging Service Technology, and is Secretary of the Long-Term Quality Alliance. Additionally, Ms. Hunt is on the Governing Board of the Patient-Centered Outcomes Research Institute (PCORI).