11th Annual Advanced Forum on False Claims and Qui Tam Enforcement - DS

EARN CLE/ETHICS/CYBERSECURITY CREDITS

11th Annual Advanced Forum on

False Claims and Qui Tam Enforcement January 23–24, 2024 | New York Bar Association, New York, NY

Distinguished Chairs:

Hear Directly From Government Enforcers:

Tara Shewchuk Global Chief Ethics & Compliance Officer Medtronic

Andy Mao Deputy Director, Fraud Section National Elder Justice Coordinator U.S. Department of Justice

Julie Bracker Partner Bracker & Marcus LLC

Brian Miller Special Inspector General for Pandemic Recovery U.S. Department of Treasury

Gustav Eyler Partner Gibson, Dunn & Crutcher LLP Former Director, Consumer Protection Branch, Civil Division, U.S. Department of Justice

Michael Galdo Director of COVID-19 Fraud Enforcement U.S. Department of Justice, Office of the Deputy Attorney General

SUPPORTING SPONSORS

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Kelly P. Mayo Director of Defense Criminal Investigative Services, Office of the Inspector General U.S. Department of Defense

Sean Leddy Assistant Special Agent in Charge, Office of Criminal Investigations U.S. Food and Drug Administration

Jacob Foster Principal Assistant Chief National Rapid Response Strike Force, Fraud Section, Criminal Division U.S. Department of Justice

Charlene Keller Fullmer Deputy Chief, Civil Division USAO, Eastern District of PA

ASSOCIATE SPONSORS

Part of C5 Group’s LEGAL GLOBAL SERIES

Hundreds of millions of dollars in government recoveries. A developing legal landscape for scienter post SCOTUS’s SuperValu decision. The creation of two new Covid-19 Fraud Strike Force Teams. The rise of data analytics and the data whistleblower. All of this, and more, has marked the False Claims Act landscape for 2024.

F

iscal Year 2022 marked the fourteenth straight year where recoveries exceeded $2 billion. The government and qui tam relators filed 948 new cases in 2022, surpassing the previous record set in 2020 (937). The FCA continues to be a powerful tool, as the statistics reflect a sustained appetite by relators to pursue FCA litigation, even when the government declines to intervene.

DOJ has continuously ramped up its investigations of pandemic-related fraud, as well as its enforcement efforts against Medicare Advantage organizations and the telehealth industry. Recent government enforcement initiatives and settlements reflect an expanding willingness by DOJ to assert liability based on the actions of third parties.

DOJ continues to employ advanced data analytics to detect potential fraud, and in some cases may issue a civil investigative demand solely relying on data-driven inferences.

By all accounts, these latest trends signal sustained and aggressive enforcement efforts by the government and qui tam relators alike.

Join us live for ACI’s 11th Advanced Forum on False Claims and Qui Tam Enforcement. Attend and hear directly from government enforcers, cross-industry compliance and investigations counsel, and leading attorneys from the defense and relators’ bar about what you can do to prepare for the next wave of FCA enforcement and stay out of the government’s crosshairs.

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DOJ False Claims Act Recoveries in 2022

hands-helping 351

Settlements

Totaling

EQUALS 2.2B $

Repeat-alt 1.7B $

$

Recovered from the healthcare industry

Meet leading industry decision-makers from: ą BAE Systems ą Bristol-Myers Squibb ą Fluor Government Group ą General Electric

Gavel

652

Qui tam suits filed in 2022

balance-scale

1.9B

$

Recovered from qui tam lawsuits

MEDIA PARTNERS

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ą Lockheed Martin Corporation ą Northwell Health ą Pfizer ą U.S. Bancorp

DISTINGUISHED FACULTY CHAIRS Tara Shewchuk Global Chief Ethics & Compliance Officer Medtronic Julie Bracker Partner Bracker & Marcus LLC Gustav Eyler Partner Gibson, Dunn & Crutcher LLP (Former Director, Consumer Protection Branch, Civil Division, U.S. Department of Justice) GOVERNMENT Andy Mao Deputy Director, Fraud Section National Elder Justice Coordinator U.S. Department of Justice Brian Miller Special Inspector General for Pandemic Recovery U.S. Department of Treasury Michael Galdo Director of COVID-19 Fraud Enforcement U.S. Department of Justice, Office of the Deputy Attorney General Kelly P. Mayo Director of Defense Criminal Investigative Services, Office of the Inspector General U.S. Department of Defense Jamie Ann Yavelberg Director, Commercial Litigation Branch (Fraud Section), Civil Division U.S. Department of Justice Jacob Foster Principal Assistant Chief, National Rapid Response Strike Force, Fraud Section, Criminal Division U.S. Department of Justice

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Brian Martens Director of Strategic Projects and Initiatives U.S. Department of Health and Human Services, Office of Inspector General Sean Leddy Assistant Special Agent in Charge, Office of Criminal Investigations U.S. Food and Drug Administration Charlene Keller Fullmer Deputy Chief, Civil Division USAO, Eastern District of PA Ken Dieffenbach, CFE, CCEP Deputy Assistant Inspector General for Investigations U.S. Department of Energy Lee M. Cortes, Jr. Executive Assistant AUSA USAO, District of NJ Miriam Glaser Dauermann Acting Assistant Chief, Criminal Division, Healthcare Fraud Unit USAO, Eastern District of NY John Vagelatos AUSA, Criminal Division USAO, Eastern District of NY Lisa Podewils Korologos AUSA, Criminal Division USAO, Southern District of NY ESTEEMED SPEAKERS Jolie Apicella Partner, Wiggin & Dana LLP (Former Chief, Civil Health Care Fraud, USAO, Eastern District of NY) Maurice Bellan Partner | Managing Partner Washington Baker & McKenzie LLP (Former Trial Attorney, U.S. Department of Justice) Renée Brooker Partner, Tycko & Zavareei LLP (Former Assistant Director, Civil Division, USDOJ)

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Matthew J. Cannon Shareholder, Greenberg Traurig, LLP (Former AUSA, USAO Central District of IL) Craig Carpenito Partner, King & Spalding LLP (Former U.S. Attorney, USAO, District of NJ) Kevin Chambers Partner, Latham Watkins LLP (Former Director of COVID-19 Enforcement, USDOJ) Brian Craig Vice President & Assistant General Counsel Science Applications International Corporation (SAIC) Jason M. Crawford Partner, Crowell & Moring LLP (Former Trial Attorney, Civil Division, Fraud Section, USDOJ) Ethan P. Davis Partner, King & Spalding LLP (Former Acting Assistant AG, Civil Division, USDOJ( Alice M. Eldridge Senior Vice-President & General Counsel BAE Systems, Inc. Justin Chiarodo Partner Blank Rome LLP Jay Dewald Partner | Head of Healthcare Investigations Norton Rose Fulbright US LLP Michael Gill Assistant General Counsel & Director of Investigations Huntington Ingalls Industries, Inc. (Former Criminal Chief, USAO, Eastern District of VA) Kevin Gingras Vice President & Associate General Counsel Litigation & Compliance Lockheed Martin Corporation (Former Trial Attorney, FCPA Unit, Fraud Section, Criminal Division, USDOJ) Scott Grubman Partner Chilivis Grubman LLP Part of C5 Group’s LEGAL GLOBAL SERIES

ESTEEMED SPEAKERS CONTINUED

Lisa Kutlin Senior Compliance Counsel, Investigations Pfizer

Jaime Raich Chief Counsel, Global Investigations, GE Aerospace (Former AUSA, USAO Southern District of FL)

Kevin Lamb Partner Wilmer, Cutler, Pickering, Hale & Dorr LLP

Eric W. Sitarchuk Partner Morgan, Lewis & Bockius LLP

Tirzah Lollar Partner Arnold & Porter

Daniel Spicehandler VP Compliance, Commercial Divisions Stryker

Mary Inman Partner Constantine Cannon LLP

Nicole Mastropieri Senior Director, Legal Counsel Teva Pharmaceuticals (Former AUSA, USAO, District of NJ)

Daniel Suleiman Partner | Co-Chair, Aerospace, Defense, and National Security Group Covington & Burling LLP

Nkechi A. Kanu Counsel Crowell & Moring LLP

Colette G. Mattzie Partner Phillips & Cohen LLP

Paul Kaufman Vice President, Deputy General Counsel Northwell Health

Patrick McCarthy Senior Vice President, Managing General Counsel Fluor Mission Solutions

Eric Triana Chief Compliance Officer, Talkiatry (Former Deputy Assistant Administrator, Diversion Control Division, DEA)

John Kokkinen Senior Associate General Counsel UnitedHealth Group (Former AUSA, Criminal Health Care Fraud Coordinator, USAO District of MN)

Krysten Rosen Moller Partner Covington & Burling LLP

Douglas Hallward-Driemeier Partner | Head of Appellate and Supreme Court Practice Ropes & Gray LLP Erica Blachman Hitchings Partner Whistleblower Law Collaborative LLC (Former AUSA, N.D. California; Former Trial Attorney, Civil Fraud Section, USDOJ)

Andrew O’Connor Partner | Co-Head of False Claims Act Practice Ropes & Gray LLP

Jonathan Kroner Founding Lawyer Jonathan Kroner Law Office

Jonathan M. Phillips Partner | Co-chair FCA/Qui Tam Defense Practice Group, Gibson, Dunn & Crutcher LLP (Former AUSA, Fraud Section, Civil Division, USDOJ)

Jennifer Verkamp Partner Morgan Verkamp LLC Jaclyn Unis Whittaker Partner Morgan, Lewis & Bockius LLP Adam Yoffie Executive Director, Head of C&E Investigations & Integrity Line, Bristol-Myers Squibb Company (Former U.S. Trial Attorney, Health Care Fraud Strike Force, USDOJ)

6000

FCA RECOVERIES

BY SECTOR

BY DOLLARS RECOVERED

In Millions

5000 4000 square Other square Dep’t of Defense square Health & Human Serv.

3000 2000 1000

2010

2011

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

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Day 1

January 23, 2024 7:45am

Registration and Breakfast

8:45am

Opening Remarks from the Conference Chairs microphone-alt Tara Shewchuk, G lobal Chief Ethics & Compliance Officer, Medtronic Gustav Eyler, P artner, Gibson, Dunn & Crutcher LLP (Former Director, Consumer Protection Branch, Civil Division, U.S. Department of Justice) Julie Bracker, P artner, Bracker & Marcus LLC 9:00am

A Year After the SCOTUS SuperValu Decision: Exploring the Impact of the Subjective Scienter Standard on File Strategy and Future Litigation microphone-alt Andy Mao , Deputy Director, Fraud Section, National Elder Justice Coordinator, U.S. Department of Justice

Recent government enforcement initiatives and settlements show the expanding reach of the FCA and a willingness to assert liability based on the actions of third parties. As the services that receive government funding become increasingly decentralized, in-house counsel must revamp their due diligence checklists to avoid enforcement risks. In this session, in-house and defense counsel will take you through the questions to ask when: • Applying recent DOJ and OIG compliance program guidance to the evolving FCA landscape • Developing new strategies to satisfy third-party compliance » How far down the supply chain should you conduct due diligence? » Formalizing requirements that business partners, agents abide by the same compliance standards as the company » Best strategies for interviewing third parties on potentially problematic conduct » Knowing which red flags can be resolved and when you should walk away from certain relationships • Reviewing best practices for compliance during M&A (due diligence as well as integration) » Exploring the risk implications when the acquired company has been funded by a private equity firm • Fine-tuning speaker programs in healthcare and strategies to ensure the procedures and policies are being followed by agents and other third parties » Unpacking the OIG Special Fraud Alert » Identifying when affiliation rules may implicate and FCA or AKS violation • Practically scoping internal investigations and how to manage third parties during the process • Considering how to best manage the implications of the Monaco memo, recidivism, and interagency collaboration » When do FCPA risks play into FCA risks (and vice versa)?

Eric W. Sitarchuk, Partner, Morgan, Lewis & Bockius LLP

11:00am Morning Networking Break

Nicole Mastropieri, Senior Director, Legal Counsel, Teva Pharmaceuticals (Former AUSA, USAO, District of NJ)

11:15am

Ethan P. Davis, Partner, King & Spalding LLP (Former Acting Assistant AG, Civil Division, USDOJ) • Learning how defense and relator’s counsel are rethinking the strength of their cases in light of the new standard » Is early dismissal based on lack of scienter harder to prove? » How should defense and relator’s counsel react?

• Learning the best strategies for advancing the defense of good faith misinterpretation of the terms of a requirement that is material to the decision to pay • Addressing how the lower courts interpret the Supreme Court’s clarifications regarding reckless disregard • Understanding how relator’s counsel and government counsel review their cases for merit in light of the subjective scienter standard 10:00am

Spotlight on Compliance: Revamping Your Third Party Due Diligence Checklist to Protect Against the FCA’s Expanding Reach microphone-alt MODERATOR: Tara Shewchuk, G lobal Chief Ethics & Compliance Officer, Medtronic Lisa LeCointe-Cephas, SVP | Chief Ethics & Compliance Officer, Office of General Counsel, Merck Daniel Spicehandler, VP Compliance, Commercial Divisions, Stryker Craig Carpenito, Partner, King & Spalding LLP (Former U.S. Attorney, USAO, District of NJ)

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The DOJ’s Civil Cyber Fraud Initiative in Action: The Latest Cross-Industry Trends and How Companies Can Become Compliant microphone-alt MODERATOR: Julie Bracker, P artner, Bracker & Marcus LLC (2024 Conference Chair) Adam Yoffie, Senior Corporate Counsel – Litigation and Government Investigations, Bristol-Myers Squibb Company (Former U.S. Trial Attorney, Health Care Fraud Strike Force, USDOJ) Tirzah Lollar, Partner, Arnold & Porter Jaclyn Unis Whittaker, Partner, Morgan Lewis & Bockius LLP Brian Craig, Vice President & Assistant General Counsel, S cience Applications International Corporation (SAIC) Andrew O’Connor, Partner | Co-Head of False Claims Act Practice, Ropes & Gray LLP This panel will examine the types of allegations that are forming the basis for actions under the cyber fraud initiative, most of which remain under seal. Topics of discussion include: • Examining cybersecurity scenarios that could potentially lead to FCA recoveries • Learning how the cyber security standards were developed and unpacking the complexity of the regulations • Unpacking the lessons learned from FCA settlements under the initiative • Considering overlapping cybersecurity requirements, such as HIPAA regulations in healthcare • Balancing the cost of becoming IT compliant against the cost of being found non-compliant, and potentially facing an FCA claim » Knowing the self-reporting considerations Part of C5 Group’s LEGAL GLOBAL SERIES

12:45pm Networking Lunch 1:45pm

Government Enforcement and Investigate Priorities: Exclusive Roundtable microphone-alt Sean Leddy, Assistant Special Agent in Charge, U.S. Food and Drug Administration, Office of Criminal Investigations Kelly P. Mayo, Director of Defense Criminal Investigative Services, U.S. Department of Defense, Office of the Inspector General Ken Dieffenbach, CFE, CCEP, Deputy Assistant Inspector General for Investigations, U.S. Department of Energy Brian Martens, Director of Strategic Projects and Initiatives, U.S. Department of Health and Human Services, Office of Inspector General In this exclusive roundtable, Inspectors General’s will share the enforcement priorities of their respective departments, as well as the focus of their investigative efforts.

2:45pm

Crunching the Numbers: The Rise of Data Relators and DOJ Data Analytics to Identify Fraud microphone-alt Scott Grubman, Partner, Chilivis Grubman LLP Jonathan Kroner, Founding Lawyer, Jonathan Kroner Law Office Lee M. Cortes, Jr., Executive Assistant AUSA, USAO, District of NJ Increased globalization and decentralization of services combined with advances in machine learning, artificial intelligence and software has ushered in a new era of data and data analytics.

In the first part of the series Crunching the Numbers, relator’s counsel and government attorneys will share valuable insights into how they use data to identify potential claims of fraud: • Demystifying how government is using data to identify outliers

4:00pm

Government Contracts Under the Microscope: Navigating Procurement Fraud and Mitigating Risk microphone-alt Jaime Raich, Chief Counsel, Global Investigations, GE Aerospace (Former AUSA, USAO Southern District of FL) Justin Chiarodo, Partner, Blank Rome LLP Nkechi A. Kanu, Counsel, Crowell & Moring LLP Michael Gill, Assistant General Counsel & Director of Investigations, untington Ingalls Industries, Inc. (Former Criminal Chief, USAO, Eastern District of VA) H In July 2023, the U.S. Department of Justice recovered $377 million dollars in one of the largest procurement fraud settlements in history. In today’s ever-evolving landscape of government contracting, ensuring transparency, accountability, and integrity is paramount. Topics of discussion include: • Revisiting strategies for calculating statutory penalties and actual damages following the Ninth Circuit’s clarifications in U.S. ex rel. Hendrix v. J-M Manufacturing Co., • Analyzing the nexus between costs charged to a government contract and the objective of the contract to avoid allegations of overcharging or misallocation of resources • Applying theories of damages relating to subpar goods or services, and defenses against them • Assessing theories to hold the prime contractor liable for a failure to oversee a subcontractor, and ensuring compliance and avoiding false certification throughout the supply chain and/or procurement processes • Understanding admissions of factual liability and explicit rejections of legal liability in the Settlement Agreement 5:00pm

The Public-Private Partnership Between Relator’s Counsel and Government: Everything You Never Knew You Never Knew microphone-alt MODERATOR: Renée Brooker, P artner, Tycko & Zavareei LLP (Former Assistant Director, Civil Division,USDOJ) Charlene Keller Fullmer, D eputy Chief, Civil Division, USAO, Eastern District of PA

» How does government assess the quality and accuracy of the data they receive?

Erica Blachman Hitchings, Partner, Whistleblower Law Collaborative LLC (Former AUSA, N.D. California; Former Trial Attorney, Civil Fraud Section, USDOJ)

» From where does government receive data?

Colette G. Mattzie, P artner, Phillips & Cohen LLP

• Learning how whistleblowers, relators, and their counsel use data to allege FCA violations • Knowing the factors considered by government before deciding to issue a CID based off data analytics » Governmental sensitivity to the costs, financial and otherwise, associated with “big data” requests » Navigating a strategic response to CID’s for a data-based claim » Balancing the cost of a comprehensive response against the benefit of an investigation ending • Exploring what an FCA defendant can argue to prevent a relator from getting past the pleading stage when the claim is based on data analytics 3:45pm

Afternoon Networking Break

This session is devoted to shedding light on the nature and context of the relationship between relator’s counsel and the government. Topics of discussion will include: • Exploring the relationship both when government declines to intervene, and when they intervene • Benchmarking which factors lead to significant changes in the cadence of this relationship? » E.g., the Supreme Court’s recent resolution of the circuit split over the government’s dismissal authority in the Polansky case • Considering practical actions that relator’s counsel may take when the government declines to intervene • Investigating how relator’s counsel can best reconcile the perception that their case is weak because the government declined to intervene » Exploring statement of interests and their efficacy

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6:00pm

Cocktails and Industry Think Tanks with ACI’s FCA Advisory Board Attendees are invited to select one of the think tank topics below for structured networking and discussion. Each think tank will be moderated by a member of the Advisory Board.

Procurement Fraud 1. In the government contracting space, what strategies and factors do you use to calculate loss? microphone-alt Alice M. Eldridge, Senior Vice-President & General Counsel, BAE Systems, Inc 2. Explore what government contractors can and should be doing today to protect against potential FCA liability from grants received under Biden’s infrastructure bill microphone-alt Patrick McCarthy, Senior Vice President, Managing General Counsel, Fluor Mission Solutions

Day 2

January 24, 2024 7:45am

Registration and breakfast

8:45am

Welcome Back from the Conference Chairs microphone-alt Tara Shewchuk, G lobal Chief Ethics & Compliance Officer, Medtronic Gustav Eyler, P artner, Gibson, Dunn & Crutcher LLP, Former Director, Consumer Protection Branch, Civil Division, U.S. Department of Justice Julie Bracker, P artner, Bracker & Marcus LLC 9:00am

SPOTLIGHT ON HEALTHCARE AND PHARMA

Life Sciences and Healthcare

Part I: Newest Trends of Enforcing and Defending Claims under the Anti-Kickback Statute and Medicare Advantage Plans

3. How are attorneys adapting their arguments in light of the circuit splits on but-for causation between alleged kickbacks and the claim?

microphone-alt Miriam Glaser Dauermann, Acting Assistant Chief, Criminal Division, Healthcare Fraud Unit, U SAO, Eastern District of NY

microphone-alt Lisa Kutlin, Senior Compliance Counsel, Investigations, Pfizer

Jay Dewald, Partner | Head of Healthcare Investigations, Norton Rose Fulbright US LLP

4. Discuss the advantages and the risks of the increasing use of technology in healthcare and the life sciences (electronic health records, real word devices/evidence, telemedicine)

Krysten Rosen Moller, Partner, Covington & Burling LLP

microphone-alt Adam Yoffie, Senior Corporate Counsel – Litigation and Government Investigations, Bristol-Myers Squibb Company, Former U.S. Trial Attorney, Health Care Fraud Strike Force, U.S. Department of Justice Constitutional and Legislative 5. What do you think of Justice Thomas’s dissent in Polansky? Are the Qui Tam provisions unconstitutional, and is a constitutional challenge likely? What would it mean for FCA practitioners if these provisions become unconstitutional? microphone-alt Ann Claire H. Phillips, Senior Vice President, Chief Government Investigations Counsel, Chief Risk Officer, Legal, U.S. Bancorp, Former AUSA 6. Discuss Senator Grassley’s proposed amendments on the FCA – do you support his perspective on materiality? Why or why not? microphone-alt Kevin Gingras, Vice President & Associate General Counsel Litigation & Compliance, Lockheed Martin Corporation, Former Trial Attorney, FCPA Unit, Fraud Section, Criminal Division, U.S. Department of Justice 6:30pm

Conference Adjourns

John Kokkinen, Senior Associate General Counsel, UnitedHealth Group Former AUSA, Criminal Health Care Fraud Coordinator, USAO District of MN Kevin Lamb, Partner, Wilmer, Cutler, Pickering, Hale & Dorr LLP Anti-Kickback Statute and Causation • Analyzing the implications of the 8th Circuit decision in United States ex rel. Cairns v. D.S. Medical LLC (July 26, 2022); United States v. Teva Pharmaceuticals 1.20-cv-11548 (D. Mass)(July 14, 2023); United States v. Regeneron Pharmaceuticals (D. Mass)(September 27 2023); and other recent decisions and petitions for certiorari regarding causation in FCA/AKS cases » Incorporating takeaways from these rulings into future litigation strategies • Examining the causation defenses from recent cases • Considering venue selection and pleadings, considering the circuit splits on causation • Appreciating the impact of HHS OIG’s revisions to the regulations implementing the AKS

Medicare Advantage Plans: Analyzing the latest DOJ investigations, enforcement activity and settlements involving Medicare Advantage plans in connection to: • Offering kickbacks to healthcare professionals and the waiver of co-payments • Risk adjustment and diagnostic coding fraud • Inappropriate restriction of beneficiary access to medically necessary care » Overzealous diagnostic testing based off available coverage and not medical necessity • Submitting inaccurate information about the health status of MA plan beneficiaries

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Part of C5 Group’s LEGAL GLOBAL SERIES

10:15am

Part II: Countering Compliance Uncertainty in the Telehealth Rules and Managing Post-Pandemic Telehealth Fraud Risks microphone-alt Jacob Foster, P rincipal Assistant Chief, National Rapid Response Strike Force, Fraud Section, Criminal Division, U.S. Department of Justice Eric Triana, Chief Compliance Officer, Talkiatry (Former Deputy Assistant Administrator, Diversion Control Division, DEA) Jolie Apicella, Partner, Wiggin & Dana LLP (Former Chief, Civil Health Care Fraud, USAO, Eastern District of NY) Jonathan M. Phillips, Partner | Co-chair FCA/Qui Tam Defense Practice Group, Gibson, Dunn & Crutcher LLP (Former AUSA, Fraud Section, Civil Division, USDOJ) Medicare providers can continue to provide telehealth at home until December 31, 2024, but complacency in reviewing potential FCA or AKS risks can be costly as DOJ remains committed to combatting telemedicine fraud post-pandemic. In this session, topics of discussion will include:

• Strategizing when the right time is to engage outside counsel to assist with an internal investigation » Strategizing who should conduct the interviews, how to record them, and what to document » Reviewing privilege and when it does and does not apply to communications between in-house and external counsel » Knowing when to implement a legal records hold • Finding the balance between protecting the company without crossing into conduct that could lead to a retaliation claim from the whistleblower » If a retaliation claim and/or class action claim is likely, should the same external counsel be used? Why or why not?

• Reviewing the Department of Justice’s corporate and criminal voluntary self-disclosure programs and analyzing the advantages and disadvantages of this strategy » If voluntary self-disclosure is not an option, how can outside counsel and in-house work together to preserve evidence and prepare the file for litigation? » Considering the benefits and pitfalls of entering into a joint defense agreement, especially Upjohn warnings

• Exploring the enforcement trends of the DOJ’s nationwide coordinated law enforcement action to combat telemedicine, laboratory and durable equipment (DME) fraud • Untangling HHS-OIG’s special fraud alert regarding telehealth arrangements » Establishing clear procedures to comply with the alert towards mitigating potential FCA and AKS risks • Clarifying what CMS’s proposed changes to Medicare telehealth policies mean for your company and how to streamline the changes in your practice

1:15pm

11:15am Morning break

2:45pm

Comments 11:30am

Pandemic Recovery Fraud: Special Interview

microphone-alt Michael Galdo, Deputy Director of COVID-19 Fraud Enforcement, U.S. Department of Justice, Office of the Deputy Attorney General Brian Miller, Special Inspector General for Pandemic Recovery, U.S. Department of Treasury INTERVIEWED BY: Kevin Chambers, Partner, Latham Watkins LLP (Former Director of COVID-19 Enforcement, USDOJ) 12:15pm

Conducting Effective Internal Investigations When the Whistleblower is an Employee: Best and Newest Practices microphone-alt Alice M. Eldridge, Senior Vice-President & General Counsel, BAE Systems, Inc Paul Kaufman, Vice President, Deputy General Counsel, Northwell Health Jason M. Crawford, Partner, Crowell & Moring LLP (Former Trial Attorney, Civil Division, Fraud Section, USDOJ) In this session, leading FCA practitioners will teach you the best strategies for handling an internal whistleblower complaint, including strategies for working effectively with outside counsel. Topics of discussion will include: • Reviewing the first and essential steps that should be taken when a whistleblower report of an FCA violation is reported internally » Appreciating the benefits and risks of monitoring communication within the company

Networking Lunch 2:15pm

Comment-Alt Keynote: U.S. Department of Justice microphone-alt Jamie Ann Yavelberg, Director, Commercial Litigation Branch (Fraud Section), Civil Division, U.S. Department of Justice

A Deep Dive into Navigating the Intricacies of Parallel Proceedings and Strategically Negotiating Global Settlements microphone-alt John Vagelatos, AUSA, Criminal Division, USAO, Eastern District of NY Lisa Kutlin, Senior Compliance Counsel, nvestigations, Pfizer Kevin Gingras, Vice President & Associate General Counsel Litigation & Compliance, Lockheed Martin Corporation (Former Trial Attorney, FCPA Unit, Fraud Section, Criminal Division, USDOJ) Daniel Suleiman, Partner | Co-Chair, Aerospace, Defense, and National Security Group, Covington & Burling LLP The DOJ’s efforts to increase corporate and executive prosecutions is increasingly resulting in parallel criminal and civil FCA proceedings. In this session, leading practitioners will conduct a deep dive into the intricacies of navigating parallel proceedings and strategies to negotiate the best outcome possible. Topics of discussion will include: • Identifying what factors in the CID or investigative interview suggest a criminal investigation is coming, and how to mitigate this risk without violating ethical or evidentiary rules » Considering what non-disclosure of potential criminal intent could mean for future civil settlement negotiations in light of DOJ’s corporate self-disclosure policy • Tackling the risks of adverse inferences when individuals plead the 5th and incorporating this possibility into settlement negotiations » Appreciating the unintended consequence of attracting the attention of the criminal division by pleading the 5th • Knowing when to hire separate counsel for the individual and the corporation and considering the benefits and pitfalls of entering into a joint defense agreement, including how Upjohn warnings work when there is a joint defense agreement • Developing unique strategies for settlements where DOJ insists on admissions and appreciating the potential impact of admissions

8 | #ACIConferences LINKEDIN Financial Services: Legal, Regulatory, Insurance and Compliance Professionals

3:45pm

Afternoon Networking Break Tara Shewchuk, Global Chief Ethics & Compliance Officer, Medtronic

4:00pm

From Prep to Verdict: Trial Advocacy Advice from Trial and Appellate Counsel microphone-alt Maurice Bellan, Partner | Managing Partner Washington, Baker & McKenzie LLP Jennifer Verkamp, Partner, Morgan Verkamp LLC

I’m excited and honored to serve as co-chair of the 11th annual Advanced Forum on False Claims and Qui Tam Enforcement. I look forward to learning the latest developments in this ever-evolving enforcement space from a multitude of experts in the field.

Douglas Hallward-Driemeier, Partner | Head of Appellate and Supreme Court Practice, Ropes & Gray LLP Although many FCA cases are filed annually, trials are rare due to frequent settlements. However, the FCA’s growing scope, encompassing areas like PPP loans, cybersecurity, telehealth, and customs, alongside traditional healthcare and procurement, hints at more upcoming trials. The now-confirmed subjective scienter standard means cases will be highly fact-specific, leading to more trials for determining the truth, making this trial advocacy refresher a can’t miss opportunity. Discussion topics include: • Contrasting how evidence is weighed differently at trial versus during the government’s investigation » What discussions remain protected as privileged and what discussions or communications can be used at trial?

• Unpacking retrospective insights from appellate counsel: the unanticipated ways that investigative efforts and first instance pleadings harm or help the case on appeal • Preparing the right jury instructions for complicated topics like scienter and recoveries • Considering the use of experts 5:00pm

Gustav Eyler, Partner, Gibson, Dunn & Crutcher LLP Former Director, Consumer Protection Branch, Civil Division, U.S. Department of Justice

I am thrilled to co-chair ACI’s 11th Annual Conference on False Claims and Qui Tam Enforcement. Please join us in New York on January 23–24, 2024, to hear from an impressive group of speakers and panelists on issues of top importance to practitioners and in-house counsel. The Conference will be an exciting opportunity to learn and build connections.

Julie Bracker, Partner, Bracker & Marcus LLC

ETHICS

Demystifying Ethical E-Discovery and Privilege in FCA Internal and External Investigations microphone-alt Lisa Podewils Korologos, AUSA, Criminal Division, USAO, Southern District of NY Patrick McCarthy, Senior Vice President, Managing General Counsel, Fluor Mission Solutions

I am delighted at the opportunity to serve as a chair, where I look forward to bringing together some of the sharpest minds in the FCA arena to discuss issues common to us all. Don’t miss out on this chance to discuss this powerful statute with other leaders in the field!

Mary Inman, Partner, Constantine Cannon Matthew J. Cannon, Shareholder, Greenberg Traurig, LLP (Former AUSA, USAO Central District of IL) • Examining the pros and cons of making conservative privilege decisions during investigations and extrapolating the potential impact on litigation or settlement » Addressing the possibility of worsening your FCA liability by being either too conservative or too open • Untangling e-discovery and privilege when a relator is involved in the investigation • Strategizing how to build credibility with DOJ through e-discovery production while avoiding ethical privilege violations • Learning the tools and strategies for comprehensive e-discovery 6:00pm

Conference Concludes

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Looking back on 40 years, we are grateful for our achievements—hosting global conferences, uniting industry leaders, and supporting business growth. However, we are not done yet! We are committed to pushing boundaries and creating impactful experiences and we're excited for the next 40 years of success.

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BUILDING VENUE INFORMATION New York Bar Association 42 West 44th Street, New York, NY 10036

ACCOMMODATIONS American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate at the Sofitel Hotel.

To take advantage of these rates, please contact the hotel directly and quote “ACI’s January Event”.

Hotel: Sofitel New York Address: 45 West 44th Street Reservations: Sandra.Schoeffler@sofitel.com or 212-782-3021 Online: To reserve online, CLICK HERE Please note that the guest room block cut-off date is December 22, 2023.

After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

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Register and pay to lock in your early rate and be eligible for a full refund until January 12, 2024.

If you are unable to attend for any reason, you will have the following options: y A full credit note for you, or a colleague to attend another event. y A full refund.

All cancellations and changes must be submitted to CustomerService@AmericanConference.com by January 12, 2024.

Dan Manganiello, American Conference Institute

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Bringing a Team?* 3–4

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5–6

15% Conference Discount

7

20% Conference Discount

8+

Call 888-224-2480

Special Discount ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service. * Team/group registrations must be from the same organization/firm and register together in one transaction.