101 Workshop: MedTech Coverage, Coding and Reimbursement

Chandra N. Branham, JD, Sr. Director, Payment & Care Delivery, Health Policy, Johnson & Johnson

Chandra Branham, JD, joined Johnson & Johnson’s Global Government Affairs and Policy team in January 2023 as Senior Director, leading health policy development for the medtech sector. She had most recently served as Senior Vice President, Payment and Health Care Delivery Policy, at the Advanced Medical Technology Association (AdvaMed), since 2011, where she led AdvaMed’s policy work in a number of areas, including Medicare coverage and payment issues, diagnostic payment, and value of medical technology. Prior to joining AdvaMed, Ms. Branham was an associate at large D.C. law firm where she focused on healthcare regulatory and legislative issues involving Medicare coverage, coding, reimbursement and quality for providers and suppliers of Medicare items and services.

Ms. Branham previously was a senior legislative analyst at the Centers for Medicare & Medicaid Services (CMS) Office of Legislation; and early in her career, served as associate director of regulatory affairs at the National Association for Home Care. She has a Bachelor of Science degree from Drexel University and a JD from the George Mason University School of Law.

Megan Anderson Brooks, PhD, President, Innovation Policy Solutions LLC

Megan Anderson Brooks, President at Innovation Policy Solutions LLC, has expertise in science and health advocacy strategies in support of an innovative and robust biomedical research system. Megan focuses on science and regulatory policy related to basic and clinical scientific research, personalized medicine, federal oversight of diagnostics and biotech devices, and patient-specific issues related to access and patient-centered treatment development. On behalf of clients, she assists in the development and implementation of policy strategies; coordinates congressional briefings and public policy symposiums; organizes client advocacy days on Capitol Hill; facilitates report language requests, and engages in direct lobbying.

As a researcher in the field of neuroscience for over a decade, Megan brings first-hand experience and a deep scientific understanding to her work on behalf of clients. She conducted research on brain health and the neural mechanisms of learning and memory, and is best known for her work to understand the role of learning in the formation of new neurons in the adult brain.

Megan previously served as a Vice President for over four years at CRD Associates. She also worked for the Society for Neuroscience developing grassroots advocacy activities and on issues related to research replicability. During a fellowship placement at the New Jersey Department of Health, she assisted in the development of a successful CDC-awarded program that aimed to promote healthy behaviors, increase electronic health record adoption, and develop community-clinical linkages to prevent and control chronic disease in the State.

Amanda Cassidy, MPP, Senior Health Policy Advisor, Arnold & Porter

Amanda Cassidy is a Senior Health Policy Advisor at Arnold & Porter and focuses on healthcare regulatory issues involving coverage, coding and payment under Medicare. Former staff in the Center for Medicare and the Office of Legislation at the Centers for Medicare & Medicaid Services (CMS), she works with device and drug manufacturers on reimbursement strategy, including developing applications for code requests and for new technology payments. She has a Master’s in Public Policy from the College of William and Mary and lives in Richmond, VA.

Sara Davis, MPH, Senior Director, Global Operations and Market Access, Health Economics & Reimbursement, Abbott Medical Devices

Sara Davis joined Abbott Medical Devices in 2016, with responsibility for developing reimbursement strategy and policy for newly approved FDA products across 5 different cardiovascular and neuromodulation therapy areas. Her areas of responsibility have grown from Payer Relations to include Operations, Customer Education and Clinical Trial Reimbursement across North and South America. Attention has primarily focused on strategic planning, correct coding initiatives, education of regional & national payors, and implementation of programs to ensure procedure approval without payer coverage, while working with clinical affairs to develop publications that will push payer coverage.

Prior to joining Abbott, Sara Davis was the Senior Director of Payer Relations and Reimbursement at Torax Medical and Director of Payer Relations and Reimbursement at Hologic, Inc. In her twelve years with the 2 companies, she was responsible for staff management, strategic planning, managed care initiatives & marketing activities, as well as reimbursement analysis for prospective company/product acquisitions.

Mark D. Domyahn, MBA, Partner, JD Lymon Group

Mark has committed his 25+ year career entirely in the health care industry with the vast majority focused on medical technology, provider reimbursement and health economics. Prior to joining JD Lymon, Mark founded Pursuance Consulting, a reimbursement and health economics consulting practice. As a consultant with JD Lymon and Pursuance Consulting, Mark has developed reimbursement strategies and executed implementation plans for numerous products for medical device and pharmaceutical companies ranging in size from start-ups to Fortune 500 companies. Direct results of Mark’s efforts include establishing payment levels for technologies prior to FDA approval, securing multiple new technology payments from Medicare, creating new CPT and HCPCS codes and engaging CMS, physician societies and other interested stakeholders to support overall reimbursement for a variety of technologies.

Mark has also served in reimbursement related leadership positions at medical device companies, including Medtronic, St. Jude Medical, Restore Medical, CardioMEMS, and Zimmer. In those roles, he had success in formulating and executing reimbursement and health economic strategies for multiple therapy areas including heart failure, cardiology, neuromodulation, orthopedics, and sleep disorders. In these roles, Mark successfully integrated reimbursement and health economics into overall business strategies to accelerate market access and increase product adoption.

Deborah R. Godes, MBA, Vice President, McDermott+ Consulting

Deborah Godes is a Vice President at McDermott+Consulting, a consulting firm that serves health industry clients with market access and policy experience supported by data analytics capabilities. Deborah is a seasoned regulatory and reimbursement consultant, advising clients on reimbursement and policy strategy for diagnostics, medical devices, biologics, and health services with public and private payers, including CMS and managed care organizations. She focuses primarily on coding, coverage, payment and other reimbursement models for new and existing products and services. She has over twenty years of experience providing strategic, operational and policy consultative services to companies of all sizes from start-up organizations to Fortune 50 companies. Deborah offers clients the ability to analyze and manipulate reimbursement databases to buttress data-oriented policy positions.

Tom A. Gustafson, PhD, Senior Policy Advisor, Arnold & Porter

Thomas Gustafson, Ph.D., is Senior Policy Advisor at Arnold & Porter, where he concentrates on health care policy and reimbursement issues. Since joining Arnold & Porter in 2008, he has advised health-care providers, device and pharmaceutical manufacturers, and trade associations on a wide array of issues, including physician, outpatient hospital clinical laboratory, and end-stage renal disease reimbursement systems; accountable care organizations; and launch and reimbursement issues, inlcuding coverage, coding and payment, for devices, laboratory tests, and pharmaceuticals.

Dr. Gustafson spent 32 years at the Department of Health and Human Services, in the Office of the Assistant Secretary for Planning and Evaluation and in the Centers for Medicare & Medicaid Services, where he held several executive posts responsible for Medicare and Medicaid legislation, strategic planning, research and demonstrations, and development and implementation of regulations. From 2003 to 2007, Dr. Gustafson served as Deputy Director of the Center for Medicare Management (CMM), which coordinated the fee-for-service portion of the Medicare program and set payment rates for more than a million providers. He supervised coding and payment policies affecting approximately $300 billion in Medicare spending on hospitals, physicians, nursing facilities, home health agencies, and other providers. He led the development and introduction of the hospital outpatient prospective payment system and major improvements in Medicare’s other payment policies and systems. He oversaw a sweeping reform, intended to improve accountability and efficiency, of Medicare’s administrative structure for paying claims. In 2006-2007, he served as Acting Director of the CMM.

Jennifer Leib, ScM CGC, Founder, Innovation Policy Solutions LLC

Jennifer Leib, founder of Innovation Policy Solutions LLC, began her career as a board-certified genetic counselor conducting clinical research in the Neurogenetics Branch at the National Institute of Neurological Disorders and Stroke at the National Institutes of Health before being selected for the prestigious National Human Genome Research Institute (NHGRI)/American Society of Human Genetics’ Genetics and Public Policy Fellowship in 2003. Jennifer worked directly in the office of then NHGRI Director Francis S. Collins, M.D., Ph.D., and also worked on the late Senator Edward M. Kennedy’s Health, Education, Labor and Pensions Committee staff for two years before transitioning to lobbying by directing the Washington, DC office of Affymetrix, a California-based biotechnology company.

Jennifer helps clients navigate the evolving regulatory and reimbursement landscape for targeted therapeutics, laboratory-based diagnostics, and mobile and digital health technologies. Jennifer also specializes in assisting young companies and associations with building a brand presence in Washington through relationship building with advocates and policymakers. Some of her key professional accomplishments include leading the advocacy effort in support of the plaintiffs in the Supreme Court’s unanimous decision in the Association for Molecular Pathology vs. Myriad Genetics Inc. that invalidated gene patents, serving on the Executive Committee of the Coalition for Genetic Fairness which successfully advocated for the enactment of the Genetic Information Nondiscrimination Act, and more recently, successfully securing national coverage for all types of SARS-Cov-2 diagnostics with varying regulatory approvals and statuses.

John S. McInnes, MD, JD, Counsel, Arnold & Porter

Dr. John McInnes, a board-certified ophthalmologist, is counsel at Arnold & Porter. He is fellowship trained in anterior segment surgery. He brings his medical experience to bear for life sciences clients navigating complex regulatory challenges. He rejoined Arnold & Porter in 2017, after almost eight years at CMS: as the Director of the Division of Outpatient Care in the Center for Medicare (OPPS/ASC), and as a Medical Officer at the Center for Medicare and Medicaid Innovation. He also served as Acting Director of the Division of Practitioner Services (PFS), the division responsible for the development of national Medicare payment policies for physician services.

In those roles at CMS, Dr. McInnes was often the principal liaison for life science companies and healthcare professional organizations, while reforming the OPPS and leading teams to develop new payment service delivery models that aim to achieve higher quality care for patients and lower costs through improvements in Medicare payment policy.

At Arnold & Porter Dr. McInnes works with both biopharmaceutical companies and medical device companies on a variety of complex reimbursement and compliance matters. He specializes in reimbursement strategy for new technologies.