Health Care Litigation, Compliance & Investigations Forum. Wednesday, October 25, 2017 The Langham Chicago
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1 Health Care Litigation, Compliance & Investigations Forum Wednesday, October 25, 2017 The Langham Chicago
2 We are pleased to invite you to 's annual Health Care Litigation, Compliance & Investigations Forum. The Forum will explore the evolving litigation and compliance risks facing health care entities today, including challenges associated with defending False Claims Act investigations and litigations; preventing and responding to data breaches; and expanding risks for health systems, manufacturers and others who contract with physician groups, among other important topics. You will hear a variety of perspectives on these key enforcement issues from government and McDermott lawyers as well as from business, legal and compliance executives from from major health care providers, payors and life science companies. We are excited to welcome Andy Slavitt, Acting Administrator for the Centers for Medicare & Medicaid Services ( ), as our keynote speaker. Mr. Slavitt will provide our attendees with a behind the scenes look at how the rules that impact the health care world are developed at the White House, Department of Health and Human Services and Congress. We hope you'll join us for one of the most informative health care events in Rebecca Martin Program Co-Chair Tom Ryan Program Co-Chair Monica Wallace Program Co-Chair Health Care Litigation, Compliance & Investigations Forum 2
3 AGENDA WEDNESDAY, OCTOBER 25 8:00 8:45 am Registration and Networking Breakfast 8:45 9:00 am Welcome and Opening Remarks Ira Coleman, Chairman, Monica Wallace,, 9:00 10:00 am General Counsel Panel What s on the Horizon? The panel, comprised of general counsel from different health care sectors, will discuss the evolving trends in the health care industry today. Matt Klein, General Counsel, Universal Health Services Brad Lerman, General Counsel, Medtronic Catherine Levitt, General Counsel, Astellas Pharma US Scott Nehs, General Counsel, Blue Cross Blue Shield Association Danae Prousis, General Counsel, Northwestern Memorial Healthcare Moderator: Jeff Stone, Chairman Emeritus, 10:00 10:45 am Compliance and Auditing Programs: How to Find Compliance Issues and Properly Address Them This panel will explore best practices, challenges and practical lessons learned in developing compliance and audit programs, including the roles of the legal and compliance departments and outside counsel, conducting compliance and audit reviews, selecting proper disclosure mechanisms and determining compliance with the 60-day overpayment rule. Lisa Estrada, Chief Compliance Officer, Fresenius Medical Care Anthony Manderschied, Chief Compliance Officer, KOS Services/Dental Dreams Laura Sak-Castellano, Vice President - Internal Audit, Advocate Health Care Tony Maida,, Moderator: Monica Wallace,, Health Care Litigation, Compliance & Investigations Forum 3
4 AGENDA 10:45 11:00 am Networking Break 11:00 11:45 am Increasing Physician Relationship Litigation Risks This panel will discuss the risks associated with physician relationships with particular focus on litigation risks and how to best address them when contracting with physicians. Litigation involving alleged violations of Stark and non-compliance with various state corporate practices of medicine and fee splitting statutes will be explored, as will recent litigation trends involving out-of-network providers and exclusive contracts. Joseph Clamon, Associate Vice President for Legal Affairs, University of Iowa Hospitals & Clinics Mary Ann E. Moore, Chief Legal Officer, MEDNAX National Medical Group Mike Austin,, Joan Polacheck,, Moderator: Tom Ryan,, 11:45 am 1:15 pm Lunch and Keynote Speaker: Andy Slavitt, Acting Administrator for the Centers for Medicare & Medicaid Services ( ) Andy Slavitt has decades of private and public sector leadership in health care. Over his career, he has shaped some of the most significant and successful health initiatives that have impacted millions of Americans and shaped the health care system. Andy served as the Acting Administrator for the Centers for Medicare & Medicaid Services (CMS) under President Obama. In that role, he oversaw programs that provide access to quality health care for 140 million Americans, including Medicaid, Medicare, the Children s Health Insurance Program and the Health Insurance Marketplace. Health Care Litigation, Compliance & Investigations Forum 4
5 AGENDA 1:15 2:00 pm How to Manage a Government Investigation The panel will examine key strategies for defending both civil and criminal investigations, including those under the False Claims Act, the Anti-kickback Statute and other statutes that govern those in the health care industry. The panel will address how to work with DOJ to reduce the scope of an investigation, how to reach resolution short of government intervention, how to anticipate issues and manage risks in matters involving qui tam relators, and when and how to deal with issues of individual liability. The panel will also address recent DOJ policies and case law, and how those influence the decisions made during the investigative phase of a case. Kevin Cornish, Managing Director, Navigant Consulting Clarice McCauley, Assistant General Counsel, Ethics and Compliance, Roche Diagnostics Linda Wawzenski, Deputy Chief, Civil Division and Head of Civil Health Care Fraud Investigations, Northern District of Illinois Mark Pearlstein,, T. Reed Stephens,, Moderator: Paul Thompson,, 2:00 2:45 pm Tales from the Front: Lessons Learned in Government Enforcement Litigation While health care organizations are often able to resolve or conclude matters at the investigation stage, it is sometimes necessary to proceed to court to litigate disputed or unresolved legal questions. The panelists will discuss how to approach the fight or flight decisions inherent in litigating, the types of issues where defendants tend to do better in court than in conference rooms, key substantive guidance coming out of recent enforcement litigation, and the government perspective on litigation risks. Lil Delcampo, Associate General Counsel, Health Sciences, University of Southern California Deborah Gordon, Chief Legal Officer /Chief Compliance Officer, Memorial Hermann Cristy Phillips, Deputy Chief of the Civil Frauds Unit, Southern District of New York Becky Martin,, Moderator: Dave Rosenbloom, Global Head of Litigation Practice, Health Care Litigation, Compliance & Investigations Forum 5
6 AGENDA 2:45 3:00 pm Networking Break 3:00 3:45 pm Health Care Cybersecurity: Risk Areas, Government Investigations and Civil Litigation The panel will address practical considerations in managing challenges involving electronic protected health information (ephi). Panelists will discuss key cybersecurity risk areas for health care organizations and effective mitigation tools. The panel will also review current trends in enforcement actions by the US Department of Health and Human Services, Office for Civil Rights (OCR) and offer insights on how to effectively manage and respond to OCR investigations. Finally, panelists will address the evolving landscape of private litigation following health care data incidents and offer insights for effectively managing the risk of private litigation. Laura Merten, Chief Privacy Officer, Advocate Health Care David Reis, PhD, Senior Vice President / Chief Information Officer, Lahey Health Jason Smolanoff, Senior Managing Director, Global Practice Leader, Cybersecurity and Investigations, Kroll Mike Morgan,, Moderator: Ed Zacharias,, 3:45 4:00 pm Closing Remarks Stephen Bernstein, Global Head of Health Practice, 4:00 6:00 pm Networking Reception Health Care Litigation, Compliance & Investigations Forum 6
7 ADDITIONAL INFORMATION ACCOMMODATIONS & ACCREDITATION The Langham Chicago 330 N Wabash Ave. Chicago, IL RESERVATIONS Our room block has now closed. If you are in need of a hotel room, please contact Sonal Sullivan at sosullivan@mwe.com. ABOUT THE VENUE Housed in a skyscraper designed by renowned architect Mies van der Rohe, The Langham Chicago is mere minutes from the Loop, Grant Park, The Magnificent Mile, Millennium Park and Navy Pier and offers majestic views of the cityscape, the Chicago River and Lake Michigan. While staying at The Langham, you ll discover the perfect blend of convenience and stylish comfort. TRANSPORTATION Ground transportation to and from The Langham is not pre-arranged. Taxis are available at O Hare International Airport (ORD) and Midway International Airport (MDW), and at The Langham. The distance between The Langham and ORD is 17 miles, and the trip takes approximately 40 minutes by car, depending on traffic. The distance between The Langham and MDW is 13 miles, and takes approximately 35 minutes by car, depending on traffic. CLE CREDIT We are pleased to offer Continuing Legal Education (CLE) credit to our attendees. CLE credit is pending in California, Illinois, New York and Texas. A Certificate of Attendance will be made available to participants requesting CLE credit in all other states. Should you be interested in obtaining CLE credit, please be sure to sign in on the appropriate sign-in sheet, which will be located at the registration desk the day of the conference. We will not be able to honor CLE credit to any individual who has not signed in. Pursuant to its responsibilities as an accredited provider of Minimum Continuing Legal Education (MCLE) in various states, McDermott has adopted financial aid/financial hardship policies to assist lawyer participants who are unable to attend programs because of cost considerations. For further information regarding CLE credit, please contact Jordan Navarro at jnavarro@mwe.com. Health Care Litigation, Compliance & Investigations Forum 7
8 SPEAKERS Mike Austin Stephen Bernstein Global Head of Health Practice Joseph Clamon Associate Vice President for Legal Affairs University of Iowa Hospitals & Clinics Ira Coleman Chairman Kevin Cornish Managing Director Navigant Consulting Lil Delcampo Associate General Counsel - Health Sciences University of Southern California Lisa Estrada Chief Compliance Officer Fresenius Medical Care Deborah Gordon Chief Legal Officer / Chief Compliance Officer Memorial Hermann Matt Klein General Counsel Universal Health Services Brad Lerman General Counsel Medtronic Catherine Levitt General Counsel Astellas Pharma US Tony Maida Anthony Manderschied Chief Compliance Officer KOS Services/Dental Dreams Becky Martin Clarice McCauley Assistant General Counsel, Ethics and Compliance Roche Diagnostics Laura Merten Chief Privacy Officer Advocate Health Care Mary Ann E. Moore Chief Legal Officer MEDNAX National Medical Group Mike Morgan Scott Nehs General Counsel Blue Cross Blue Shield Association Mark Pearlstein Cristy Phillips Deputy Chief of the Civil Frauds Unit Southern District of New York Joan Polacheck Danae Prousis General Counsel Northwestern Memorial Healthcare David Reis, PhD Senior Vice President / Chief Information Officer Lahey Health Dave Rosenbloom Global Head of Litigation Practice Tom Ryan Laura Sak-Castellano Vice President - Internal Audit Advocate Health Care Andy Slavitt Acting Administrator for the Centers for Medicare & Medicaid Services ( ) Jason Smolanoff Senior Managing Director, Global Practice Leader, Cybersecurity and Investigations Kroll T. Reed Stephens Jeff Stone Chairman Emeritus Paul Thompson Monica Wallace Linda Wawzenski Deputy Chief, Civil Division and Head of Civil Health Care Fraud Investigations Northern District of Illinois Ed Zacharias Health Care Litigation, Compliance & Investigations Forum 8
9 SPONSORS McDermott thanks the following Health Care Litigation, Compliance & Litigations Forum sponsors: DIAMOND GOLD Health Care Litigation, Compliance & Investigations Forum 9
10 WHAT IF Compliance with industry rules and regulations was business as usual? Working side-by-side with our clients and their counsel, we apply our extensive litigation capability, investigation experience, and industry insight to provide solutions that deliver powerful results. At Navigant, we help turn what if into what is. OUR SERVICES INCLUDE: Investigation Support Government Settlement Negotiation Support Compliance Program Development, Implementation, and Evaluation Government Monitorships and IRO Support Services Litigation Support Data Analytics and Customized Technology Solutions Regulatory Strategy Quality System Design and Update PROFIT FROM EXPERIENCE OUR EXPERTS INCLUDE: Navigant.com/FinancialServices Former regulatory agency and FDA execs Former compliance and risk officers Expert testifiers Data analysts navigant.com 2017 Navigant Consulting, Inc. All rights reserved. W18473
11 ABOUT McDERMOTT is a premier international law firm with a diversified business practice. Numbering more than 1,000 lawyers, we have offices in Boston, Brussels, Chicago, Dallas, Düsseldorf, Frankfurt, Houston, London, Los Angeles, Miami, Milan, Munich, New York, Orange County, Paris, Rome, Seoul, Silicon Valley and Washington, DC. Further extending our reach in Asia, we have a strategic alliance with MWE China Law Offices in Shanghai. McDERMOTT HEALTH With more than 30 years of experience serving the health care industry, s Health Industry Advisory Practice Group is one of the world s largest and most prestigious. Our group is interdisciplinary, bringing together all of the regulatory, transactional, finance, real estate, restructuring and tax knowledge necessary to deliver effective, efficient and focused services to our health industry clients and those entities seeking to invest in the health industry. McDermott is the undisputed leading law firm in health care as evidenced by the fact that McDermott is the only firm to receive Tier 1 rankings in health care nationally by all of the industry s top legal directories: Chambers USA, The Legal 500 USA and U.S. News Best Lawyers. For the eight consecutive year, Chambers USA ranked the Firm s health practice as the only firm in Tier 1 in the United States ( ). Visit our website for more information about McDermott s health practice. McDERMOTT LITIGATION GROUP Our Firm s Litigation Practice Group provides clients with litigation skills and experience effective in the many areas of law and business where disputes arise. We are regularly engaged in all aspects of civil, regulatory and white-collar criminal defense litigation in US and international forums. Our goal is to efficiently resolve disputes to the satisfaction of clients, whether by trials, alternative dispute resolution or favorable settlements. With more than 50 experienced trial lawyers and more than 100 health regulatory, transaction and compliance lawyers in offices located across the globe, we have one of the largest and most accomplished health care litigation practices worldwide. We represent clients in civil and criminal litigation, US Office of Inspector General (OIG) investigations, corporate internal investigations, data privacy investigations and litigation, congressional hearings, and domestic and international arbitrations. Visit our website for more information on McDermott s litigation practice This communication may be considered attorney advertising. Previous results are not a guarantee of future outcome.
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