Paying for Cell and Gene Therapies in Medicare

The first gene therapy, called Chimeric Antigen Receptor (CAR)-T cell therapy, was approved by the FDA in 2017 after it showed remarkable results with certain blood cancers.  But it took three years for CMS to approve a payment structure for hospitals that enabled Medicare patients to access the breakthrough treatment. The process threatens to repeat itself with dozens of promising gene therapies in coming years, imperiling lives and innovation, unless reforms are made.

On January 29, the USC-Brookings Schaeffer Initiative for Health Policy will host a Richard N. Merkin, MD Distinguished Speaker Series webinar on policy lessons learned and potential solutions to support innovation and patient access in cell and gene therapies. Moderated by Schaeffer Center Director Dana Goldman, the conversation will feature Jeet Guram, former senior advisor at CMS and the FDA, and Kathy Buto, a veteran health policy expert whose experience spans leadership roles in CMS, the Congressional Budget Office (CBO) and Johnson & Johnson, including developing payment and cost models for new drugs and devices.

Event Date
Friday, January 29, 2021
9:00 AM - 9:45 PM Pacific
Dana Goldman is the Interim Dean at the USC Sol Price School of Public Policy, as well as the Leonard D. Schaeffer Chair and Distinguished Professor of Pharmacy, Public Policy, and Economics at the University of Southern California. Goldman began serving in his new capacity as interim dean on July 1, 2020. One of his first initiatives is to establish the Price School Social Justice Advisory Board representing faculty, staff and students. He is an elected member of the National Academy of Medicine and the National Academy of Social Insurance – two of his field’s highest honors.   He is the author of more than 300 articles and book chapters, and his research has been published in leading medical, economic, health policy, and statistics journals.  He has raised over $100 million in funding from external sources—including more than $50 million from the National Institutes of Health. Goldman pioneered the “Netflix model” to improve access to prescription drugs and the value of reduced copayments for the chronically ill.  He served as a formal health policy advisor to the Congressional Budget Office, Covered California, National Institutes of Health, and the Fred Hutchinson Cancer Institute.  He serves on the editorial boards of Health Affairs and the American Journal of Managed Care and is founding editor of the Forum for Health Economics and Policy. His work has been featured in the New York Times, Wall Street JournalWashington PostThe Economist, NBC Nightly News and other media.  He is former director of ISPOR and ASHEcon and a co-founder of Precision Health Economics, a health care consultancy.  Goldman received his B.A. summa cum laude from Cornell University and a Ph.D. in Economics from Stanford University.
Kathy Buto is currently an independent consultant, focused on health policy issues. She recently served as a Commissioner, Medicare Payment Advisory Commission, which advises Congress and the Administration on Medicare payment and coverage policy. She serves as a venture advisor for InCube Labs, a research and venture capital organization. Ms. Buto retired in March 2013 as Vice President, Global Health Policy, at Johnson & Johnson, where she was responsible for identifying opportunities for J&J to take leadership in shaping health policy globally. She managed a team that included physicians, economists, and health policy analysts that addressed issues, such as expanding access to health services for populations in emerging markets, interacting with health care authorities, and promoting preventative care globally.
Prior to joining J&J, Kathy was a senior health adviser at the Congressional Budget Office, helping to develop the cost models for the Medicare drug benefit. Before that, she spent more than 18 years in senior positions at the Health Care Financing Administration, now called the Centers for Medicare and Medicaid Services. In these positions, she headed the policy, reimbursement, research, and coverage functions for the agency, as well as co-leading Medicare’s fee-for-service and managed care organizations.
Kathy was the recipient of 5 Presidential Rank Awards and the 1999 Public Service Award while in government and the New Jersey’s Women and Industry Award in 2010, while at Johnson & Johnson. She received her Bachelor of Arts from Rutgers University and her Masters in Public Administration from Harvard University.
Dr. Jeet Guram most recently served as a Senior Advisor to the Commissioner of the Food and Drug Administration, where he supported the agency’s response to COVID-19. Prior to that, he was a Senior Advisor to the Administrator of the Centers for Medicare & Medicaid Services, where he led efforts to modernize payment policies for innovative new therapies and lower prescription drug costs. Dr. Guram has an M.D. from Harvard Medical School and an M.B.A. from Harvard Business School, and he worked at McKinsey & Company before entering the government. He has been published in Health Affairs and The New England Journal of Medicine.