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2023年8月22日（火） 6:00 - 8:00 pm

SC1: PAMA Reform: Reimbursement Challenges and Pathways Forward
SC1：PAMA改訂：償還の課題と今後の進路

6:00 pm

PAMA Reform: Reimbursement Challenges and Pathways Forward

Adam Borden, Senior Vice President of Policy & Strategy, American Clinical Laboratory Association

Tara Burke, PhD, Vice President, Payment and Healthcare Delivery Policy, AdvaMed

Samuel K. Caughron, MD, FCAP, Chair, Economic Affairs Committee (EAC), AMP; President, CEO & Director of Molecular Lab, MAWD Pathology Group; Chair of Pathology and Clinical Lab Medical Director, AdventHealth Kansas City

Nicholas Halzack, MPH, Director, Health Policy, Roche Diagnostics

This course will describe the reimbursement landscape under PAMA, the current expected outlook for 2024 lab payments, and examine how the Medicare process for rate-setting for new diagnostic tests interacts with PAMA policy. There will also be a discussion about ongoing efforts to reform the underlying statute, including details about the Saving Access to Laboratory Services Act of 2022 (SALSA), and how passage and implementation of a similar policy might impact lab reimbursement in the future. Understanding this complex legislation and how it may change is crucial to ensuring the existence of a strong diagnostic laboratory infrastructure after the COVID-19 public health emergency.

7:30 pm Concluding Panel Discussion

PANEL MODERATOR:

Nicholas Halzack, MPH, Director, Health Policy, Roche Diagnostics

PANELISTS:
Adam Borden, Senior Vice President, Policy & Strategy, American Clinical Laboratory Association

Tara Burke, PhD, Vice President, Payment and Healthcare Delivery Policy, AdvaMed

INSTRUCTOR BIOGRAPHIES:

Adam Borden, Senior Vice President of Policy & Strategy, American Clinical Laboratory Association

Adam R. Borden joined ACLA in July 2022 as Senior Vice President of Policy and Strategy. He has had a diverse career in healthcare and has developed deep knowledge and understanding of federal health policy, provider reimbursement, and the changing landscape of healthcare delivery in the United States. Adam was previously Vice President of Market Access and Reimbursement at Cleerly, Inc. and Senior Director of Policy and Reimbursement Strategy at Siemens Healthineers, where he led strategic efforts for all business areas including imaging, laboratory diagnostics, and digital products. During this time, Adam served as Chair of the Reimbursement Committee at the Medical Imaging & Technology Alliance (MITA) and Chair of the Diagnostics Payment Work Group at AdvaMedDx. Adam also spent time as Vice President/Director at the premier D.C.-based policy consulting firm Avalere Health, and worked in health policy, reimbursement, and administrative roles at the American Gastroenterological Association and several leading academic medical centers. He is a member of the Advisory Board at the Cancer Support Community's Cancer Policy Institute. Adam holds a Bachelor of Arts degree from Rutgers University and a Master of Health Administration degree from A.T. Still University of Health Sciences.

Tara Burke, PhD, Vice President, Payment and Healthcare Delivery Policy, AdvaMed

Tara Burke joined AdvaMed in 2022 and currently serves as Vice President of Payment and Healthcare Delivery Policy. Previously, he served as Senior Director of Public Policy and Advocacy at the Association for Molecular Pathology, where she focused on the regulatory and reimbursement issues affecting molecular diagnostics. Dr. Burke has over a decade of biomedical research experience specializing in biochemistry, molecular genetics, and epigenetics. After receiving her BS in Molecular Biology from Vanderbilt University and a PhD in Biochemistry and Molecular Genetics from The University of Virginia, she completed a postdoctoral fellowship at The National Institute of Child Health and Human Development (NICHD) at the NIH.?Her training and research in molecular genetics showed her the hope and promise that genetics can bring to improving human health, and she is proud to be able to work towards the realization of this goal.

Nicholas Halzack, MPH, Director, Health Policy, Roche Diagnostics

Nick is the Director of Health Policy at Roche Diagnostics Corporation. He believes that diagnostics are one of the most crucial elements to improving public health, and that broad access to new diagnostic technologies is based on a solid foundation of reimbursement and access policies. Prior to Roche, Nick worked on federal health policy at the American Society of Anesthesiologists and Nemours Children's Health System. He holds a M.P.H. in Health Policy from The George Washington University and a B.S. in Biological Sciences from Cornell University.

2023年8月22日（火） 6:00 - 8:30 pm

SC2: Translating CTCs, ctDNA, and Exosomes for Clinical Use
SC2：臨床使用のCTC、ctDNA、エクソソームの翻訳

6:00 pm

Translating CTCs, ctDNA, and Exosomes for Clinical Use

Utkan Demirci, PhD, Professor of Radiology, Canary Center for Cancer Early Detection, Stanford University

Gozde Durmus, PhD, Assistant Professor, Radiology, Stanford University

Short Course attendees will learn about the current landscape of ctDNA, CTCs, exosomes, and extracellular vesicles (EVs) applied for translation in the clinic. This course will focus on liquid biopsy biomarker isolation and enrichment, assay, and product development. Finally, attendees will gain perspective on the hurdles faced when diagnostics are translated into the clinic.

INSTRUCTOR BIOGRAPHIES:

Utkan Demirci, PhD, Professor of Radiology, Canary Center for Cancer Early Detection, Stanford University

Dr. Utkan Demirci is a tenured professor at Stanford University School of Medicine and currently serves as the interim director and division chief at the Canary Center for Cancer Early Detection in the Department of Radiology. Prior to joining Stanford in 2014, he held the position of Associate Professor at the Brigham and Women’s Hospital, Harvard Medical School, at the Harvard-MIT Health Sciences and Technology division. His research group is focused on the early detection of cancer and has made significant contributions to the development of microfluidic platforms and point-of-care technologies for sorting rare cells and exosomes. He was elected as a fellow of the American Institute of Medical and Biological Engineering in 2017. With a PhD in Electrical Engineering from Stanford University in 2005, as well as an MS in Electrical Engineering and an MS in Management Science and Engineering in the same year, Dr. Demirci has an impressive academic background. He has published over 250 peer-reviewed articles, 300 abstracts and proceedings, 24 book chapters and editorials, and 7 edited books. Additionally, he holds over 25 patents, both granted and pending, and serves on the editorial board of various peer-reviewed journals. Dr. Demirci's pioneering work in infertility has resulted in the creation of cutting-edge devices and platforms. These innovations have undergone translation and approval by the FDA and CE, making them readily accessible to patients globally.

Gozde Durmus, PhD, Assistant Professor, Radiology, Stanford University

Dr. Gozde Durmus is an Assistant Professor of Radiology at Stanford University. She conducted her postdoctoral research at Stanford; working with Prof. Ronald W. Davis at the Stanford Genome Technology Center. She received her Ph.D. degree in Biomedical Engineering from Brown University in May 2013, with a minor in Innovation Management and Entrepreneurship. She is also an alumna of the Ignite Program at the Stanford University Graduate School of Business. She was a Fulbright Scholar at Boston University and received her M.Eng. degree in Biomedical Engineering as a College of Engineering Fellow in 2009. She received her B.S. degree in Molecular Biology and Genetics from Middle East Technical University (METU) in 2007. She has been recognized among the "Top Innovators Under 35" (TR35) by the MIT Technology Review. She received the Career Award at Scientific Interface from Burroughs Wellcome Fund (BWF-CASI) in 2018. She has been named a "Rising Star in Biomedicine" by the Broad Institute of MIT and Harvard. Recently, Dr. Durmus has received major research awards, such as the Moore Inventor Fellow, Baxter Faculty Scholar Award, and Koret Foundation Catalyst Award. Dr. Durmus is also a co-founder of LevitasBio, a start-up company in Silicon Valley commercializing magnetic levitation-based devices for label-free sample processing.

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2023 Conference Programs