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Medtech Payment Summit

Wednesday, September 18, 2024 (8:00 AM - 4:00 PM) (EDT)

Description

Our Medtech Payment Summit is a unique event that discusses various payment models and reimbursement pathways for medical devices, diagnostics and digital health products. Featuring interactive panels with medtech leaders and hospital partners, the Summit will help to clarify the payment pathways for your product and build relationships among industry peers.

Kicking off the day with an optional "Payment 101 Crash Course," the agenda will include presentations and panel discussions on various payment models featuring real-world case studies, as well as topics such as, the evolving political and legal landscape around payment policy and recent updates including the Supreme Court's recent ruling on the Chevron Deference.

This is a great program to garner actionable information about identifying and securing relevant payment pathways for your products, as well as a chance to get your questions answered by our experts.

We will provide a Uniform Certificate of Attendance for in-person attendees should you wish to apply for continuing education units (CEU).

AGENDA

Time	Session	Speaker(s)

8:00 AM	Registration, Breakfast & Networking
8:30 AM	Payment 101 (Optional) Join us for a crash-course on payment 101! This high-level overview will equip you with payment processes, procedures and important terms if you are not in the space or need a refresher. Come and get a CliffsNotes version of the payment landscape for medical devices to help you navigate conversations that will dive deeper throughout the day.	Angela Lively, Senior Advisor, Covington & Burling
10:00 AM	Welcome Remarks
10:05 AM	Overview of Possible Payment Models This session will include strategy of payment models for your medical device, to include possible payment models: reimbursement code coverage, direct to insurance/hospital, and direct to consumer.	Rujul Desai, Partner, Covington & Burling Michelle Fox, Corporate Vice President and Chief Medical Officer, Teleflex Stephanie Wimmer, Global Vice President, Health Economics, Market Access, and Reimbursement (HEMAR), Philips Head of Population Health, Best Buy Health
10:45 AM	Working with CMS This session will highlight the payment pathway of receiving reimbursement through CMS. Presentations will be in the form of case studies.	Ira Goldman, VP of Government Affairs, Lantheus Yajuan Lu, J.D., Director, Corporate Health Policy & Reimbursement, Boston Scientific Nick Doucette Manager, Health Policy & Reimbursement, Novocure
11:30 AM	Networking Break
11:45 AM	What’s Next: Will Congress Act on Payment Policy after TCET? In August, CMS released its long-awaited final guidance on the Transitioning Coverage of Emerging Technologies or TCET, capping an eight-year journey from the first introduction of a breakthrough pathway for medical devices to receive transitional coverage. However, the limited scope of TCET leaves much to be desired and it is not the game changer the device industry has been hoping for. Congress has a chance to improve the program with HR 1691, the Ensuring Patient Access to Critical Breakthrough Products Act of 2023. With just three months left in the session, and a national election ahead, will any action be taken on this critical legislation? Hear from experts on what to watch out for in this critical debate.	Lee A. Fleisher, M.D., M.L., Principal and Founder, Rubrum Advising
12:15 PM	Lunch & Networking
1:15 PM	What the Jarkesy, Chevron and Cornerpost Decisions Mean for You Over the course of three days this summer, the U.S. Supreme Court dealt a three-punch combination to the vast array of federal agencies and sub-agencies that critics refer to as “the administrative state.” While each case represented a significant development in its own right, the cumulative effect of all three cases will have a generational effect on the way federal agencies act, defend their rules and regulations, and operationalize their enforcement activities. Join this session to learn how this tectonic shift in federal administrative law will affect the entire healthcare system for better, or for worse.	Andrew S. Tsui, Of Counsel, Greenberg Traurig
1:45 PM	Ask the Experts Do you have a question not covered on the agenda? This is your opportunity to ask our panel of medtech reimbursement and policy experts your questions.	Michael Hill, Managing Principal, Healthcare Business Consulting, EPAM Continuum Patrick Cunningham, Founder and Principal, Re-architect Health LLC Michael Ferguson, Ph.D., Vice President, Global Healthcare Economics and Reimbursement, AtriCure Melissa Schooley, VP, Global HEMA & GA, Abiomed, part of JNJ MedTech
2:30 PM	Networking Break
3:00 PM	Hospital Value Analysis Submission and New Therapies This session will highlight the payment pathway of receiving payment through a hospital system. Through a moderated panel discussion, we’ll hear from decision makers at leading hospital systems and medtech companies, including how to influence their buying decisions and keys to value analysis when reviewing new therapies.	Liz Kwo, MD, MBA, MPH, Chief Commercial Officer of Everly Health Stacey A. Bunk, MS, CPC, CCC, FABC, Director, Reimbursement & Market Access, AtriCure Charlie Miceli C.P.M., Strategic Advisor Network Finance, University of Vermont Health Network
3:45 PM	Closing Remarks

SPEAKERS

	Stacey Bunk, MSc, CPC, CCC, FABC Director of Market Access and Reimbursement AtriCure With over 25 years of experience in healthcare, Stacey has held leadership roles in both hospital settings and the medical device industry. Previously, she served as the Revenue Director at a large academic medical center in Boston and Vice President of a hospital system encompassing community and academic hospitals. At a medical device company focused on cardiovascular care, Stacey led the global reimbursement strategy. She collaborated with federal agencies to establish new Diagnosis Related Groups (DRGs) as well as successfully transitioned their technology into existing DRGs that better reflected the cost of care for critically ill patients. Stacey holds a Master's degree in Organizational Leadership, is a certified coder, and is a Fellow of the Advisory Board Company. Her career has been dedicated to advancing patient care through sustainable financial models and innovative solutions.
	Patrick Cunningham Founder and Principal Re-architect Health LLC Patrick is the Founder and Principal at Re-architect Health LLC, a firm which provides consulting services on the architecture of virtual care delivery models, including the formation, reimbursement, operation, and scalability of technology-enabled specialty service lines. Current clients include pharmaceutical manufacturers, medical device manufacturers, and venture-backed start-ups building virtual clinics for chronic diseases, neurology, cardiology, and women’s health among others. Previously, Patrick was an early employee at Onduo, a joint venture between Sanofi and Verily Life Sciences, and was directly responsible for building and scaling the first nationwide virtual diabetes clinic as well as value-based contracting with commercial and government payers. Patrick earned a BS in Chemistry from Bates College and an MBA from the Tuck School of Business at Dartmouth College.
	Rujul Desai Partner Covington & Burling Rujul Desai is a Partner in Covington's Washington, DC office, where he is a member of the Health Care and Digital Health Practice Groups. He advises life science clients on novel contracting, compliance, and policy issues related to pricing, market access, and reimbursement for medical products. He brings decades of experience advising on the complex system of federal and state laws governing the healthcare industry. Rujul regularly advises drug, biologic, device, and diagnostic manufacturers on legal risk assessments involving new product launches, government and commercial pricing, PBM and payer formulary access, value-based contracting, GPO and supplier arrangements, patient access and hub services, affordability programs, e-prescribing, telehealth, digital health, and the use of health economic data and modeling.
	Nick Doucette Manager, Health Policy & Reimbursement Novocure Nick has developed a broad knowledge of the Reimbursement workflow in his five years with Novocure. In his most recent role, he focused on strategy and scaling opportunities including projects that led to the implementation of projects that created efficiencies supporting patients. Nick manages the relationships and coverage policy with the Department of Veterans Affairs and State Medicaid Agencies. He lives in New Hampshire with his wife, two girls, and Golden Retriever. In his free time, he enjoys teaching his girls to golf, running, and spending time by the water with family.
	Michael Ferguson Vice President of Healthcare Economics and Reimbursement AtriCure Michael is the Vice President of Healthcare Economics and Reimbursement for AtriCure, a surgical medical device company focused on treatment of atrial fibrillation. Michael has responsibility for overall reimbursement, health economics, and market access strategy. Some of his groups work and collaboration with specialty societies has resulted in new CPT and MS-DRG payment codes. Prior to his role at AtriCure he held leadership positions at Boston Scientific, Philips Healthcare, and Medtronic. He earned his PhD at the University Florida in Applied Physiology.
	Lee A. Fleisher, MD, ML CEO Rubrum Advising, LLC Lee A. Fleisher, MD, ML (Masters in Law) is the Founding Principal and CEO at Rubrum Advising, LLC, a consulting firm dedicated to identifying strategic pathways, including regulatory counsel, to ensure the highest quality care is adopted and diffused across the healthcare sector. From July 2020-July 2023, he was the Chief Medical Officer and Director of the Center for Clinical Standards and Quality for the Centers for Medicare and Medicaid Services. 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 Steering Committee of CHAI (Coalition of Health AI), consultant to the FDA Digital Health Advisory Committee and a member of the HITAC of the ONC. 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 and is currently Emeritus Professor and continues to practice clinically. In 2007, he was elected to membership of the National Academy of Medicine.
	Michelle Fox Corporate Vice President & Chief Medical Officer Teleflex As the Chief Medical Officer of Teleflex, Michelle Fox and her leadership team set the clinical vision and strategy for Teleflex. She provides leadership to Medical Affairs which provides medical guidance for the Company’s global product portfolio and assures compliance with global regulatory, legislative and medical requirements. Clinical Affairs representatives lead the design of and implementation of multidisciplinary clinical development programs covering a broad range of products and therapeutic areas in collaboration with strategic business partners. Michelle also leads the scientific, clinical research and reimbursement arm of the organization. Michelle’s work has focused on organizational and systems development. This includes interactive medical education, as a means to making transformational change and supporting research that implements the best medical practices into bedside clinical care. Michelle offers a rare blend of strong clinical practice and leadership, driven by her desire to improve patient outcomes, and tempered by a clear understanding of the challenges facing healthcare today.
	Ira N. Goldman Vice President, Global Public Policy and Government Relations Lantheus Holdings Ira N. Goldman is Vice President, Global Public Policy and Government Relations, Lantheus Holdings. He is Co-Chair of the Isotope Supply Committee, Council on Radioisotopes and Radiopharmaceuticals (CORAR) and Vice-Chairman of the Security of Supply Working Group, Nuclear Medicine Europe. Mr. Goldman is responsible for development and execution of Lantheus’s strategy and actions for public and healthcare policy, including legislative strategy and interactions with the U.S. Congress as well as relationships with Executive Branch agencies.He coordinates Lantheus’s involvement with trade associations, business and regional advocacy groups and medical societies. He also interacts with U.S. and foreign governments and international organizations regarding medical isotope production and supply matters. Mr Goldman earned a Master of Arts in International Affairs (with distinction) from the Johns Hopkins University Nitze School of Advanced International Studies in Washington DC in 1980, including study at the Johns Hopkins Centre for European Studies in Bologna, Italy (1978-1979). Mr Goldman earned a Bachelor of Arts (with honours) in History and was Phi Beta Kappa at Trinity College, Hartford, Connecticut in 1978.
	Michael Hill Managing Principal, Healthcare Business Consulting EPAM Continuum Mr. Hill brings 25+ years of Business Value & Healthcare Transformation for health systems, health plans, and innovative healthcare companies. Prior to joining EPAM, Mike served numerous consulting and leadership roles focused on business transformation and optimizing healthcare economic and clinical outcomes through deployment of technology, data, predictive analytics, and payer and provider collaboration. Selected prior client organization work includes national and regional payers including Optum/UnitedHealth Group, Aetna/CVS, Blue Cross Blue Shield Plans, and others; large academic health systems, and innovative technology and value-based care companies specific to the Medicare Advantage business.
	Liz Kwo, MD, MBA, MPH Chief Commercial Officer Everly Health Dr. Liz Kwo is a transformative physician entrepreneur, payer executive, and instructor at Harvard Medical School. Dr. Liz Kwo is currently the Chief Commercial Officer of Everly Health, a digital health company at the forefront of the $300 billion virtual diagnostics-driven care industry. With a proven track record of building companies for two decades, Dr. Kwo authored “DIGITAL MD: Revolutionizing the Future of Care” and served as Deputy Chief Clinical Officer for Elevance (NYSE: ELV) modernizing care for 43 million Americans in Medicare, Medicaid, and Commercial populations. Prior to Elevance, Dr. Kwo started several venture backed companies as the CEO and co-founder of InfiniteMD (acquired by Consumer Medical), and President and co-founder of New Pathway Education and Technology Group (acquired by EIC Education). Dr. Kwo is on the Board of Directors of Asensus Surgical (NYSE AMERICAN: ASXC), Walmart Mexico and Central America (Mexican Stock Exchange/BMV: WALMEX), BlueWind Medical and ChroniSense. Dr. Kwo continues to see patients in urgent care at Cambridge Health Alliance Hospital, teach residents as a faculty lecturer at Harvard Medical School, and is board certified in Preventive Care and Occupational Medicine. She earned a BA in Human Biology from Stanford University, MD from Harvard Medical School, MBA from Harvard Business School, and an MPH from Harvard T.H. Chan School of Public Health.
	Angela (Menchaca) Lively Senior Advisor Covington & Burling Angela (Menchaca) Lively is a Senior Advisor in Covington’s Health Care and Digital Health Practice Groups. She has decades of experience analyzing, understanding and determining implications of health and reimbursement policy changes on beneficiaries, providers, health systems and manufacturers, particularly as it relates to access to new technology. Throughout her industry and consulting experience she has supported the launch of dozens of products and has spent her career understanding the intersection of coverage, coding, and reimbursement with broader health policy change and the effect of those changes on patient and provider decision making. She has particularly focused on the market access elements of health system change, coverage, coding, and reimbursement across settings of care, beneficiary protections, value determination, alternative payment models, and quality measurement.
	Yajuan Lu Director, HEMA Boston Scientific Yajuan Lu is a Director of the Boston Scientific Corporate HEMA team, leading the company’s corporate Medicare policy strategies. Prior to BSC, Yajuan worked at Johnson and Johnson, where she advanced through a number of roles, including Director of U.S. Coverage and Reimbursement Policy and Lead of China Health Policy. Prior to her experience with the private sector, Yajuan served in Senator Grassley’s personal office as a David A. Winston Health Policy fellows. Yajuan graduated from University of Pittsburgh School of Law, and obtained Bachelor’s degree from Peking University Health Science Center.
	Charlie Miceli Strategic Advisor for Finance University of Vermont Health Network Charlie Miceli Currently serves as Strategic Advisor for Finance at University of Vermont Health Network. Charlie served at University of Vermont Health Network Chief Supply Chain Officer through March 2024. Charlie has also served as Interim CEO for both Inter-Lakes Heath in 2010-2011 and 2014 as well as CIO for One Care Vermont and Deputy CIO and VP Pharmacy for UVM Medical Center. Prior Supply Chain roles include Chicago (Northwestern, Loyola and Univ of Chicago) and Boston (Partners Healthcare and Newton Wellesley) as well as consultancy for BD Health Care Consulting and Services. In October 2023 he was inducted into the Bellwether League Foundation Healthcare Supply Chain Hall of Fame. He earned a B.A. in Psychology from Notre Dame.
	Melissa Schooley VP, Global HEMA & GA Abiomed, part of JNJ MedTech Melissa manages Abiomed US and Global health economics and market access strategy consistent with the core principles of recovering hearts and saving lives. She specializes in the intersection of reimbursement, health economics, policy, and government advocacy. She has led and works closely with our physician partners and patient advocates to support coverage, coding, and payment for new technologies. She has held leadership roles in payment and advocacy within AdvaMed and has served on the steering committee and advisory roles for the Medical Device Innovation Consortium (MDIC). Melissa has over 25 years of market access and reimbursement experience, most recently working for Medtronic. She worked on Capitol Hill for the Senate Judiciary Committee and has a law degree from American University and degree in Political Science and Business from JMU. Melissa also serves on the Virgina Tech Fralin Biomedical Research Institute Board. Her career has been focused on advancing innovation and supporting patient access to care.
	Andrew Tsui Of Counsel Greenberg Traurig Drawing on more than a decade of experience litigating on behalf of the U.S. Department of Health and Human Services (HHS), Office of the General Counsel for the Centers for Medicare & Medicaid Services (CMS) Division, Andrew Tsui represents healthcare providers, suppliers, and laboratories in complex, government-facing investigations, appeals, and direct litigation. Andrew also provides regulatory and compliance counsel to healthcare and life sciences companies requiring an insider’s view to the federal framework. Andrew’s recent work includes advising early-stage start-up companies in digital and AI-enhanced healthcare technologies. Andrew obtained his law degree from the University of North Carolina School of Law and his Master’s of Public Health from the UNC Gillings School of Global Public Health. He graduated with high honors from Wesleyan University in Middletown, CT.
	Stephanie Nelson Wimmer, MBA, MPH Vice President Global Health Economics, Market Access, and Reimbursement (HEMAR) Philips Stephanie currently leads the Global Health Economics, Market Access, and Reimbursement (HEMAR) organization for Philips, championing patient access for Philips’s $18B product portfolio. She previously served as the VP, Health Economics Policy, and Reimbursement for Medtronic’s Medical Surgical Portfolio where she led a suite of global shared functions including, health economics and outcomes research (HEOR), global market access strategy development and evidence planning, field reimbursement, and health policy. Stephanie holds a Bachelor of Arts in American Studies and Religion from Hamilton College (Clinton, New York), a Master of Business Administration from the Amos Tuck School at Dartmouth College (Hanover, New Hampshire), and a Master of Public Health in Health Policy and Administration from the Mailman School at Columbia University (New York, New York). She also is a graduate of General Electric’s Financial Management Program.