AdvaMed® Payment Policy Forum

Dr. Alpert served as Vice President of Regulatory Sciences for C.R. Bard, Inc. She also previously worked at FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the Director of the Office of Device Evaluation. Dr. Alpert is a microbiologist and a pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials.

Dr. Alpert serves on the board of advisors for the Medical Technology Leadership Forum and the board of the Women Business Leaders, or organization of women leaders in the health care sector. She also serves on the Executive Committee of the Clinical Trials Transformation Initiative, one of the public/private partnerships working with FDA to streamline the development of medical products.

Carol Blackford is the Executive Vice President of Payment and Health Care Delivery Policy at AdvaMed. AdvaMed’s Payment and Health Care Delivery Policy department develops and advocates for policies to ensure and expand patient access to medical technologies by improving coverage, coding, and payment processes used by Medicare and commercial payers.

Ms. Blackford comes to AdvaMed with over two decades of health care policy experience. Prior to joining AdvaMed in 2023, Ms. Blackford served as a Senior Executive and Director of the Hospital and Ambulatory Policy Group in the Center for Medicare & Medicaid Services (CMS). In this role, Ms. Blackford had responsibility for payment and benefits policy on the acute care side of the Medicare Fee-For Service Program. These payment systems, which account for approximately $270 billion in Medicare spending, include inpatient and outpatient hospital services, physician services, Part B drugs and laboratory services, and other acute care services and providers. During her 28 year career at CMS, Ms. Blackford lead work in every major Medicare fee-for-service payment system and served in a number of enterprise wide leadership roles, including serving as the Agency’s COVID-19 Pandemic Response Coordinator.

Chris serves as Director, Healthcare Economics for Impulse Dynamics, Inc., a medical device manufacturer dedicated to transforming treatment of chronic heart failure. Previously, he has held positions at medical device manufacturers of various size in sales, sales management, strategy and healthcare economics. Additionally, he held multiple roles for a privately-held owner/operator of specialty medical practices in the U.S. and overseas. He started his career in the financial technology sector. Chris earned his B.A. from Pennsylvania State University and M.B.A. from the University of Michigan.

He and his amazing wife, Kristen, have three terrific children. They also have two equally terrific doodles, both of whom occasionally offer canine opinions on matters related to coding, coverage, payment and policy on conference calls. Working in the medical technology and healthcare fields has given Chris the opportunity to learn from many amazing individuals from a wide range of backgrounds. The chance to participate in exchange of ideas with such people at conferences like this one is something he considers a great privilege.

Lindsay Bockstedt, Ph.D. is Vice President of Global Health Economics and Outcomes Research at Medtronic, Inc. In her role, Dr. Bockstedt leads the global HEOR function at Medtronic, focusing on developing evidence to support the coverage, payment, and access to medical technologies. She has established enterprise-wide standards to ensure transparency, reproducibility and rigor for non-interventional studies using secondary data. Dr. Bockstedt has deep domain expertise in observational research methods, real-world data regulations, health policy, and health technology assessment. She has led several RWE programs, including highly visible ones that have established new approaches and standards for the application and use of RWE in regulatory and payer decision-making. Her work has influenced international medical guidelines and has been published in top-tier journals.

She received her Ph.D. and M.S. in health services research and policy from the University of Minnesota, and B.S. in public health from Rutgers University. Dr. Bockstedt sits on multiple industry leadership groups for organizations such as International Society for Pharmacoeconomics Research (ISPOR) Institutional Council, Health Technology Assessment International, and the Medical Device Innovation Consortium.

Lee A. Fleisher, MD, ML (Masters in Law) is the former Chief Medical Officer and Director of the Center for Clinical Standards and Quality for the Centers for Medicare and Medicaid Services (2020-2023) and Founding Principal and CEO at Rubrum Advising. He is currently Emeritus Professor of Anesthesiology and Critical Care at the University of Pennsylvania Perelman School of Medicine and continues to practice clinically. He is also the LLC. He serves as a Senior Advisor of the Bipartisan Policy Center and FasterCures of the Milken Institute, Senior Fellow of the Leonard Davis Institute of Health Economics and Visiting Fellow of the Duke-Margolis Center. He is a member of the HITAC of the ONC. As CMS CMO, he was responsible for executing all national clinical, quality, and safety standards for healthcare facilities and providers, as well as establishing coverage determinations for items and services that improve health outcomes for Medicare beneficiaries.

From 2004 through July 2020, he was the Robert D. Dripps Professor and Chair of Anesthesiology and Critical Care and Professor of Medicine at the University of Pennsylvania. In 2007, he was elected to membership of the National Academy of Medicine of the National Academy of Sciences and served on Committees including the Board of Health Services of the NAM.

Nancy Foster is the former Vice President for Quality and Patient Safety Policy at the American Hospital Association. In this role, she provided advice to public policymakers on legislation and regulations intended to improve patient safety and quality in America’s hospitals and health systems. Nancy worked with the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Administration for Strategic Preparedness and Response and several other federal agencies.

She was the AHA’s point person at the National Quality Forum and the AHA’s liaison to the Joint Commission’s Board. She represented hospital and health system perspectives to key policymakers and played a pivotal role during the COVID 19 pandemic to assist the Federal agencies with information and secure Agencies help as hospitals dealt with surging demand for care and shortages of needed resources. Prior to joining the AHA, Nancy was the Coordinator for Quality Activities at the Agency for Healthcare Research and Quality (AHRQ) and principal staff person for the Quality Interagency Coordination Task Force. She led the development of patient safety research agenda for AHRQ and managed a portfolio of quality and safety research grants in excess of $10 million. She is a graduate of Princeton University and has completed graduate work at Johns Hopkins University. In 2000, she was chosen as an Excellence in Government Leadership Fellow.

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, 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 U.S. Department of Health and Human Services, 24 of which were at 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.

Jamie Haggard co-founded Green Sun Medical in 2013 and is currently Board Chair and CEO.  Green Sun Medical is transforming the treatment of scoliosis.  Jamie brings over 20 years of award-winning executive experience in the spine and orthopedic implant industry.  Prior to founding Green Sun Medical, he held two VP of sales positions.  During his career, he has helped launch disruptive technologies such as the artificial disc replacement and lateral spine fusion implants.  In addition, he was named to AdvaMed’s Orthopedic Sector, Digital Health Executive Leadership Team, and Pediatric Working Group.
Jamie is passionate about improving pediatric medical device outcomes.

Beth Halpern helps health care clients achieve coverage and reimbursement for innovative technologies. She advises pharmaceutical and device manufacturers, health care providers, and trade associations about Medicare and other payers’ policies and develops strategies to improve access to care. Beth helps clients advocate before administrative agencies and Congress, and she advises about Medicare law for clients involved in litigation.

In more than 15 years of practice, Beth has worked with clients on securing coding, coverage, and reimbursement for many new drugs, devices, and medical services. By analyzing the regulatory landscape, including Medicare’s payment systems for drugs and biologicals, physicians, hospitals, dialysis clinics, and durable medical equipment, she has helped clients benefit from health reform and take advantage of incentive payments for new technologies. She advises clients not only about what the law is now, but also about how to change the law, drafting amendments to the Medicare law and successfully advocating for changes to regulations and coverage policies.

Zach Hochstetler is the Vice President of CPT Coding and Payment at the American Medical Association’s Health Solutions business unit. He leads the strategic development of the AMA’s CPT® code set and CPT Editorial Panel process, working closely with key stakeholders to deliver trusted, high-value data to the healthcare ecosystem. Under his leadership, CPT continues to evolve as the definitive standard for procedure coding, ensuring the AMA remains at the forefront of healthcare innovation, data integrity, and reporting accuracy.

Robert Jarrin is a strategic advisor on digital health and medicine to various companies, associations, and medical organizations. Jarrin’s areas of expertise include CPT coding of digital services, CMS coverage and payment of digital medical services, FDA regulation of digital health, and ONC policies on Health IT interoperability.

Jarrin has served on several Federal Advisory Committees covering innovation, safety, health IT standards, and consumer advocacy. He has testified numerous times before the U.S. House of Representatives providing expert testimony on innovation, mobile medical apps, and the 21st Century Cures Act. Jarrin has also participated on a federally sponsored Technical Expert Panel (TEP) on the use of technology to facilitate clinical preventive services. He currently serves as a founding member of the American Medical Association (AMA) Digital Medicine Payment Advisory Group (DMPAG).

Justin Klein, MD, JD, is a co-founder and Managing Partner at Vensana Capital, a leading venture capital and growth equity firm dedicated to medtech innovation. Justin currently or previously served on the board of directors of Apella, Cartiva (acquired), ChromaCode, Cleerly, Curate BioSciences, CV Ingenuity (acquired), Epix Therapeutics (acquired), Evident Vascular, Intact Vascular (acquired), Personal Genome Diagnostics (acquired), PhaseBio Pharmaceuticals (IPO), Relievant Medsystems (acquired), Senseonics (IPO), Topera (acquired), Ulthera (acquired), Vertiflex (acquired), Vesper Medical (acquired), and VytronUS (acquired). Justin currently serves as a member of the board of directors of the Medical Device Manufacturers Association and that of AdvaMed Accel, where he is the Vice Chair of the Investor Advisory Committee of AdvaMed’s board. He is also a member of the board of directors of CareFirst BlueCross BlueShield, one of the country’s largest not-for-profit healthcare organizations that serves over 3.5 million patients in the greater Washington, DC, region.

Prior to Vensana, Justin was a partner and leader of the medical technology investing practice at NEA, one of the largest and most active venture capital firms in the world. Justin also worked at the Duke University Health System where his experience included roles in strategy, finance, and operations as Duke built one of the nation’s first integrated healthcare delivery systems. Justin graduated with an AB in Economics, a BS in Biological Anthropology & Anatomy, and a Minor in Chemistry from Duke University. He also concurrently earned an MD from the Duke University School of Medicine and a JD from Harvard Law School.

Parashar is an accomplished healthcare executive with a demonstrated history of leadership in the medical device industry and public sector. He brings more than 30 years of health policy and market access experience to clients.
Parashar develops efficient and effective plans to engage stakeholders, including healthcare policymakers and payers in the United States and abroad. His areas of expertise include payment and coverage policy, market access strategies, healthcare delivery systems, medical devices and clinical research.

Prior to joining McDermottPlus, Parashar served as senior vice president for government affairs and market access at ViewRay, where he led global efforts to drive adoption of MRIdian in cancer treatment. He previously led Boston Scientific’s global teams focused on the development and execution of market access, health economics and public policy strategies for key technologies.

Christine oversees the strategic planning and execution of coding, coverage, and payment strategies for the Transcatheter Mitral and Tricuspid Therapies (TMTT) portfolio at Edwards Lifesciences. She focuses on health policy and reimbursement for a portfolio that includes early-stage technologies to commercialized technologies. Her work requires close cross-functional collaboration across Edwards, as well as with external groups including professional societies, policymakers, and patient advocacy groups. Christine’s areas of focus include US health policy, reimbursement strategy planning (including coding, coverage, and payment), Medicare payment systems (IPPS, OPPS, ASC, PFS, and others), clinical trial reimbursement, and reimbursement training programs.

Prior to joining Edwards, Christine worked for 14 years as a health policy and market access consultant developing reimbursement strategies and advancing policy to achieve market access for healthcare companies. As a consultant, she supported her reimbursement strategy and health policy work with data analytics, including budget impact models, gaining insights from real-world data, Medicare claims analyses, and replication of Medicare payment calculations. Christine received her Bachelor’s degree from Johns Hopkins University and Master’s degree in Public Health from Yale University. She resides in Los Angeles, CA with her family.

Elizabeth Thoma is the Director of Health Economics and Reimbursement for Abbott’s Structural Heart business. After engineering roles across pharmaceutical and medical device manufacturing and research and development, she took an opportunity to learn about health economics and outcomes research. For over 10 years now she has focused on global market access and value enablement through evidence generation.

Venk is the co-founder and Chief Executive Officer of Nanowear, a New York-based connected-care and companion diagnostics technology platform built upon first-of-its-kind cloth-based nanosensors. Nanowear was founded in 2014 and received its first FDA 510(k) Class II clearance in December 2016, establishing Nanowear as the first-and-only company in the world to receive this accreditation for cloth-nanotechnology-based remote monitoring. Nanowear’s first product, SimpleSense, which launched clinically in July 2019, is an undergarment that captures and algorithmically scores 7 metrics from the body, alerting hospital providers of worsening Heart Failure ~3 weeks in advance of a hospitalizing event. Nanowear’s business model centers around its CHF digital therapeutic device and select licensing opportunities of its cloth-based nanosensors to Healthcare OEMs.

Before Nanowear, Venk spent ~7 years in Technology Investment Banking, focusing exclusively on venture-backed software and communications technology in which he successfully advised growth companies in over $3bn USD worth of transactions at UBS Investment Bank, Citadel Investment Group and Wells Fargo Securities in New York. Prior to his finance career, Venk spent ~ 3 years in product marketing and sales at Eli Lilly and Sanofi Aventis Pharmaceuticals in New York.