Sean Tunis, MD, MSc. is a Principal with Rubix Health where he consults with public and private sector organizations on health technology issues at the interface of regulatory and reimbursement policy, market access, comparative effectiveness, outcomes measurement and health technology assessment. He is also a Senior Fellow in the Tufts Center for the Evaluation of Value and Risk in Health. Dr. Tunis also serves as a Mentor-in-Residence at Johns Hopkins Tech Ventures, helping early stage companies to develop their initial reimbursement strategy and to align their clinical development programs with payer and regulatory requirements.
In 2020 and 2021, Dr. Tunis served as a Senior Advisor in the Office of the Principal Deputy Commissioner at the Food and Drug Administration, where he worked on the use of real-world data to inform regulatory and reimbursement decisions for medical devices and diagnostics.
From 2006 to 2019, Dr. Tunis was the Founder and CEO of the Center for Medical Technology Policy in Baltimore, Maryland. CMTP is an independent, non-profit organization that provides a neutral platform for multi-stakeholder collaborations that are focused on improving the quality, relevance, and efficiency of clinical research.
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. 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 master’s 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, Tufts and the University of California San Francisco Schools of Medicine.