9th Annual Advanced Forum on False Claims and Qui Tam Enforcement - DS

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June 22–23, 2022 | New York Marriott Downtown | New York, NY

9th Annual Advanced Forum on

False Claims and Qui Tam Enforcement Responding to the Expanding Reach of the FCA Learn Enforcement Priorities Directly from Government Philip Selden First Assistant United States Attorney United States Attorney’s Office, District of Maryland Sean Keveney Deputy General Counsel U.S. Department of Health and Human Services

Brian D. Miller Special Inspector General for Pandemic Recovery (SIGPR) U.S. Department of The Treasury

y Regeneron Pharmaceuticals Inc. y Huntington Ingalls Industries, Inc. y Northwell Health y Bayer US LLC

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Michael Granston Deputy Assistant Attorney General, Civil Division U.S. Department of Justice

Richard Hayes Deputy Chief, Civil Division Eastern District of New York

Robert J. Troester United States Attorney Western District of Oklahoma

Insights from Key Industry Stakeholders at:

Kevin Andrew Chambers Associate Deputy Attorney General Director of Covid-19 Fraud Enforcement Department of Justice

Scott Spiegelman Acting Bureau Chief Investor Protection Bureau NYS Office of the AG

Matthew Feeley Deputy Chief, Civil Division U.S. Attorney’s Office, Southern District of Florida

Michael J. Petron CPA, CFE, Manager, Forensic Investigations Group Executive Office of United States Attorneys

John Vagelatos Assistant United States Attorney, Criminal Division Eastern District of New York

Sean O’Donnell Acting Inspector General U.S. Department of Defense

Conference Co-Chairs Joseph “Jody” Hunt Partner Alston & Bird LLP (Former Assistant Attorney General, United States Department of Justice) Kirsten Mayer Head of U.S. Compliance, Vice President, Legal argenx, US, Inc

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The United States Department of Justice (DOJ) released its annual statistics for the False Claims Act (FCA) and fraud cases for fiscal year 2021. The DOJ reported that it recovered $5.6 billion in final judgments and settlements during this time period—the second largest annual total in FCA history, and the largest since 2014.

With 598 qui tam lawsuits filed in 2021, and 203 filed by DOJ, the recovery statistics for fiscal year 2021 show a sustained and aggressive use of the FCA by the government and qui tam relators alike.

The DOJ also announced that the Civil Division will “energetically use every enforcement tool available to prevent wrongdoers from exploiting the COVID-19 crisis.” In addition, DOJ appointed a Chief Prosecutor to lead pandemic recovery fraud efforts.

Finally, DOJ revealed the creation of a Civil Cyber-Fraud Initiative that will utilize the FCA to pursue cybersecurity related fraud by government contractors and grant recipients.

By all accounts, the trend for government initiated FCA actions is continuing to climb, leaving the industry wondering: ĉ What will total recoveries amount to at the end of Fiscal ‘22?

ĉ Which industries are at greatest risk?

ĉ What can we expect for Fiscal ‘22?

ĉ What can you do now to prepare for the next wave of FCA enforcement and protect your client’s interests?

ĉ Where will government enforcement priorities lie?

ACI’s 9th Advanced Forum on False Claims and Qui Tam Enforcement, taking place IN-PERSON in New York City, will address the underlying controversies and challenges posed by these questions. Join us for in-depth discussions and analyses of the latest guidance, initiatives, and enforcement statistics, featuring a faculty of government speakers and leading defense, in-house, and relators’ counsel.

DOJ False Claims Act Recoveries in 2021

Repeat-alt $

BY DOLLARS RECOVERED

Recovered due to False Claims Act lawsuits

6000

5B

$

Recovered from healthcare and life sciences alone

WHISTLE 598

Whistleblower qui tam suits filed in 2021

Gavel

FCA RECOVERIES BY SECTOR

203

Non qui tam suits initiated

by DOJ

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5000 In Millions

balance-scale

5.6B

$

4000 3000 2000 1000

2010

2011

square Other

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 square Dep’t of Defense

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square Health & Human Serv.

DISTINGUISHED FACULTY 2022 Co-Chairs Joseph “Jody” Hunt Partner Alston & Bird LLP (Former Assistant Attorney General, United States Department of Justice)

Kirsten Mayer Head of U.S. Compliance, Vice President, Legal argenx, US, Inc

Government Philip Selden First Assistant United States Attorney United States Attorney’s Office, District of Maryland Sean Keveney Deputy General Counsel U.S. Department of Health and Human Services

Richard Hayes Deputy Chief, Civil Division Eastern District of New York John Vagelatos Assistant United States Attorney, Criminal Division Eastern District of New York

Robert J. Troester United States Attorney Western District of Oklahoma

Matthew Feeley Deputy Chief, Civil Division U.S. Attorney’s Office, Southern District of Florida

Brian D. Miller Special Inspector General for Pandemic Recovery (SIGPR) U.S. Department of The Treasury

Kevin Andrew Chambers Associate Deputy Attorney General Director of Covid-19 Fraud Enforcement Department of Justice

Scott Spiegelman Acting Bureau Chief Investor Protection Bureau NYS Office of the AG Michael Granston Deputy Assistant Attorney General, Civil Division U.S. Department of Justice Michael J. Petron CPA, CFE, Manager, Forensic Investigations Group Executive Office of United States Attorneys Sean O’Donnell Acting Inspector General U.S. Department of Defense

Esteemed Faculty Arunabha Bhoumik Executive Director, Assistant General Counsel | Head, General Litigation and Government Investigations Regeneron Pharmaceuticals, Inc. Julie Bracker Founding Partner Bracker & Marcus LLC Renée Brooker Partner Tycko & Zavareei LLP Hui Chen Ethics & Compliance Expert HC Ethics LLC Daniel Chudd Corporate Director Division Counsel Northrop Grumman Zachary Coseglia Managing Principal, Head of Innovation, and Co-Lead Ropes & Gray LLP Insights LAB Emily Derr Director, Healthcare Counsel Alkermes Jay Dewald Head of Healthcare Investigations, United States Norton Rose Fulbright LLP

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David Eskew Founding Partner Abell Eskew Landau LLP Todd Haugh Associate Professor of Business Law and Ethics Indiana University – Kelley School of Business Gregory Krakower Adjunct Professor of Law Cardozo Law School Carrie Sarhangi Love Partner Armstrong Teasdale Lon R. Leavitt Partner Chair of FCA/Whistleblower Practice Group Halunen Law Joseph Mack Senior Assistant General Counsel Bayer US LLC Hamsa Mahendranathan Partner Constantine Cannon Patrick McCarthy Vice President Law Managing General Counsel Fluor Mission Solutions Ryan McCarthy Parnter Morgan Lewis

Jason Mehta Partner Bradley Arant Boult Cummings LLP Lynn Neils Partner Foley Hoag Allison O’Neil Partner Locke Lorde Michael E. Paulhus Partner King & Spalding J.B. Perrine Assistant General Counsel Huntington Ingalls Industries, Inc. Galia Porat Associate General Counsel Teva Pharmaceuticals Greg Radinsky, JD Senior Vice President & Chief Corporate Compliance Officer Northwell Health Jaime Raich Executive Counsel, Global Investigations General Electric Company Michael Rogoff Partner Arnold & Porter Kaye Scholer LLP

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Eric Sitarchuk Partner Morgan Lewis Brendan Stewart Of Counsel Gibson Dunn LLP Robert M. Thomas, Jr. Managing Member, Co-Founder Whistleblower Law Collaborative LLC Roderick L. Thomas Partner Wiley Rein LLP Robert Vogel Partner Vogel, Slade and Goldstein LLP Jeb White President & CEO Taxpayers Against Fraud Adam Yoffie Senior Corporate Counsel, Litigation & Government Investigations Bristol Myers Squibb Maryana Zubok Assistant General Counsel, Litigation Pro Bono Lead, Legal Division Pfizer Inc.

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Day 1 Wednesday, June 22 7:45 | Registration and Breakfast 8:45

Opening Remarks from Co Chairs Microphone-alt Joseph (Jody) Hunt, Partner, Alston & Bird (Former Assistant Attorney General, United States Department of Justice) Kirsten Mayer, Head of U.S. Compliance, Vice President, Legal, argenx, US, Inc 9:00

A Special Interview with Microphone-alt Michael Granston, Deputy Assistant Attorney General, Civil Division, U.S. Department of Justice 9:45

Materiality, Scienter, and Falsity: Clarity or More Confusion?

Microphone-alt Arunabha Bhoumik, Executive Director, Assistant General Counsel, Head, General Litigation and Government Investigations, Regeneron Pharmaceuticals, Inc. Carrie Sarhangi Love, Partner, Armstrong Teasdale Lynn Neils, Partner, Foley Hoag Michael Rogoff, Partner, Arnold & Porter Maryana Zubok, Assistant General Counsel, Litigation, Pro Bono Lead, Legal Division, Pfizer Inc.

11:00 | Networking Break 11:30

Cybersecurity Fraud: The New Frontier in FCA and Qui Tam Enforcement?

Microphone-alt Richard Hayes, Deputy Chief, Civil Division, United States Attorney’s Office, Eastern District of New York Renee Brooker, Partner, Tycko & Zavareei LLP David Eskew, Founding Partner, Abell Eskew Landau LLP Greg Radinsky, JD, Senior Vice President & Chief Corporate Compliance Officer, Northwell Health Although cybersecurity fraud is not new, DOJ’s focus, via the creation of the Cyber-Fraud Initiative, suggests an uptick in cybersecurity-based FCA actions, coming from a growing pool of whistleblowers — those in IT and tech. No matter what your current level of familiarity is with cybersecurity, this panel will prepare you and your clients for the next wave of claims.

Topics of discussion will include: • Understanding the three facets of cybersecurity fraud that form the focus of DOJ’s enforcement initiative • Reviewing the Federal Acquisition Regulation and the Defense Federal Acquisition Regulation to understand what makes a cybersecurity program compliant » Including the U.S Department of Defense (DoD)’s Cybersecurity Maturity Model Certification (CMMC) program • Discovering common pitfalls that may give rise to an FCA claim and how to mitigate those risks • Learning lessons from the cases that have resolved before and after the initiative began 12:30

Advanced Advocacy in FCA and Qui Tam Claims: The Defense Perspective Microphone-alt Jason Mehta, Partner, Bradley Arant Boult Cummings LLP

Federal courts issued a number of important FCA related decisions over the past year. There also have been policy changes concerning agency guidance (the Brand and Garland memos), as well as a new enforcement cadence under the Biden administration, with modifications to DOJ’s policy manuals. And Senator Grassley has proposed legislative amendments to the FCA. Each of these could impact how you assess and prepare your cases. In this extended session, points of discussion will include:

During this session, leading defense lawyers will present advanced tactics for preparing and defending against FCA and Qui Tam claims. Topics of discussion will include:

• Legal developments based on recent and important federal court decisions concerning materiality, scienter, and falsity

• Reviewing the different types of subpoenas and civil investigative demands (CIDs) and negotiating their scope with DOJ

• Strategizing venue selection and pleadings in light of widening Circuit splits on dismissal authority and changing government policies

• Establishing positive dialogue with government attorneys and considering the value of cooperation credit

• Extrapolating the impact of policy changes and federal court decisions on litigation strategy

• Seeking declination and dismissal

Eric Sitarchuk, Partner, Morgan Lewis Brendan Stewart, Of Counsel, Gibson Dunn LLP

• Addressing the unique considerations that arise from criminal, parallel or administrative proceedings • Understanding the unique aspects of litigation where the government does not intervene, but the relator continues • Special considerations for private equity firms

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1:30 | Networking Lunch 2:45

Drafting, Pleading, and Litigating: The Relator’s Counsel Perspective Microphone-alt Julie Bracker, Founding Partner, Bracker & Marcus LLC Robert Vogel, Partner, Vogel, Slade & Goldstein, LLP Jeb White, President and CEO, Taxpayers Against Fraud The DOJ’s FY21 report shows that whistleblowers and their counsel initiated 75% of all FCA matters in FY21. In this panel, leading relator’s counsel will discuss: • Understanding the practicalities of choosing one venue over another • Addressing pleading standards under the Federal Rules of Civil Procedure • Proceeding to litigation with the intervention of DOJ versus without the intervention of DOJ • Overcoming statutory barriers, such as public disclosure 3:45

Afternoon Break

Day 2 Thursday, June 23 7:45 | Registration and Breakfast 8:45

Opening Remarks from Co-Chairs and Recap of Day 1 9:00

The Who, What, Where, and When of Pandemic Fund Recovery Microphone-alt Moderator: Brian Miller, Special Inspector General for Pandemic Recovery, U.S. Department of the Treasury Philip Selden, First Assistant United States Attorney, United States Attorney’s Office, District of Maryland Sean Keveney, Deputy General Counsel, U.S. Department of Health and Human Services Kevin Andrew Chambers, Associate Deputy Attorney General, Director of Covid-19 Fraud Enforcement, Department of Justice

4:00

Optimal Strategies for Resolving FCA Matters and Qui Tam Lawsuits Microphone-alt Emily Derr, Director, Healthcare Counsel, Alkermes Joseph Mack, Senior Assistant General Counsel, Bayer US LLC

Robert J. Troester, United States Attorney, U.S. Attorney’s Office for the Western District of Oklahoma Sean O’Donnell, Acting Inspector General, U.S. Department of Defense

This session is devoted to the last mile of FCA and qui tam proceedings.

Leading in-house, defense and relator’s counsel will discuss:

We all know the why: $6 trillion dollars were made available to those suffering financially from the pandemic via federal stimulus programs from the CARES Act, and some of that funding was obtained fraudulently.

The DOJ is prioritizing recovery of these funds, through civil, criminal, or parallel proceedings, and the creation of specialized task forces and Inspectors General (IG). In this government-led roundtable, topics of discussion will include:

• Negotiating a favorable resolution (damages, multipliers, and cooperation credit)

• Reviewing a Main Street Lending Program and Paycheck Protection Program (PPP) fraud case by the U.S. Attorneys who prosecuted them

• Satellite negotiations: relator’s share, fees

• Assessing the Health and Human Services (HHS) approach to Provider Relief Fund (PRF) fraud enforcement

Allison O’Neil, Partner, Locke Lorde Robert M. Thomas, Jr., Managing Member, Co-Founder, Whistleblower Law Collaborative LLC

• Resolving partially intervened cases and declined cases • Dealing with sanctions other than fines and restitution, e.g., corporate monitorship and corporate integrity agreements • Mitigating the reputational harm that comes with a settlement or judgment at trial 5:30

Champagne Roundtables

• Hearing the government’s priorities in terms of recovering pandemicrelated fraud • Learning how DOJ and other government agencies approach collaboration in pandemic fraud recovery (e.g., Memorandums of Understanding and parallel investigations) 10:00

Critical Developments Involving the Stark Law, the AntiKickback Statute, and Medicare Advantage Program Microphone-alt Hamsa Mahendranathan, Partner, Constantine Cannon Ryan McCarthy, Partner, Morgan Lewis Galia Porat, Associate General Counsel, Teva Pharmaceuticals Adam Yoffie, Senior Corporate Counsel, Litigation & Government Investigations, Bristol Myers Squibb Of the total FY21 recoveries, 90% ($5B) came from the healthcare and life sciences industries. The DOJ will continue to focus its enforcement efforts on individuals and entities in these industries. In this session, leading defense, in-house, and relator’s counsel will discuss:

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The Stark Law and the Anti-Kickback Statute (AKS) • Analyzing the impact of the changes to the Stark Law • Analyzing the impact of HHS OIG’s revisions to the regulations implementing the AKS • Discussing the takeaways from important cases • Reviewing best practices for parallel proceedings

3:00

Government Procurement Fraud and the FCA: An In-Depth Exploration of Unique Legal Considerations and Enforcement Trends Microphone-alt Daniel Chudd, Corporate Director Division Counsel, Northrop Grumman

Medicare Advantage Program

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

• Risk Adjustment Diagnosis Coding • Trends in Medicare Advantage litigation

James Perrine, Assistant General Counsel, Huntington Ingalls Industries, Inc

11:00 | Networking Break

Jaime Raich, Executive Counsel, Global Investigations, General Electric Company

11:30

Understanding DOJ’s Enforcement Priorities: Private Equity, Telehealth, Electronic Health Records (EHRs) and Opioids Microphone-alt Matthew Feeley, Deputy Chief, Civil Division, U.S. Attorney’s Office, Southern District of Florida Jay Dewald, Head of Healthcare Investigations, United States, Norton Rose Fulbright LLP Michael E. Paulhus, Partner, King & Spalding The DOJ announced it will strengthen its focus on rooting out potential fraud amongst private equity firms, telehealth, EHRs, and the ongoing opioid crises. In this session, topics of discussion will include:

• Critical developments with respect to telehealth including why DOJ is emphasizing enforcement • Understanding how EHRs are used and where to look for fraud detection and prevention • Issue-spotting and important considerations for private equity firms and their principals • Reviewing EKRA and Opioid enforcement considerations 12:30

Crunching the Numbers: The Use of Data Analytics and Statistical Sampling to Identify and Prosecute Fraud Microphone-alt John Vagelatos, Assistant United States Attorney, Criminal Division, United States Attorney’s​Office, Eastern District of New York Lon R. Leavitt, Partner, Chair of FCA/Whistleblower Practice Group, Halunen Law Michael Petron, CPA, CFE, Manager, Forensic Investigations Group, Executive Office of United States Attorneys Statistical sampling is one tool available to extrapolate liability under the FCA, as well as determine damages. In recent years, DOJ has significantly increased filing its own FCA claims, which it directly attributes to the use of data analytics. Numbers are clearly a game-changer in civil and criminal liability under the FCA. In this session, topics of discussion include: • How DOJ conducts data analysis to extrapolate potential liability • Knowing which agencies coordinate and share information with DOJ • Strategies for and against the use of statistical sampling as a basis for liability and damages 1:30 | Networking Lunch

Roderick L. Thomas, Partner, Wiley Rein LLP Combating procurement fraud remains a priority of the federal government.

With the recent passing of a $2 trillion-dollar Bipartisan Infrastructure Law, this in-depth exploration of government procurement fraud is most timely.

In this session, in-house and defense counsel will discuss: • Some of the most charged fraud cases including fraud regarding nonconforming materials, cost mischarging, and defective pricing • How to predict and manage collateral consequences in procurement fraud (e.g., suspension and debarment and criminal liability) • Unique considerations flowing from self-disclosures and the mandatory self-disclosure requirement in the Federal Acquisition Regulation (FAR) • Potential liability of prime contractors for fraud allegations involving subcontractors • Emerging theories of False Claims Act liability 4:00 | Networking Break 4:30

Fireside Chat: A Primer on Tax FCA and Qui Tam Special Guest: Microphone-alt Scott Spiegelman, Acting Bureau Chief, Investor Protection Bureau, NYS Office of the AG Interviewed by: Gregory Krakower, Adjunct Professor of Law, Cardozo Law School 5:00 ETHICS

Proactively Combating the Potential for Fraud: Behavioral Ethics and Fraud Prevention Microphone-alt Zachary Coseglia, Managing Principal, Head of Innovation, and Co-Lead, Ropes & Gray LLP Insights LAB Hui Chen, Ethics & Compliance Expert, HC Ethics LLC Todd Haugh, Associate Professor of Business Law and Ethics, Indiana University – Kelley School of Business Moderator: Kirsten Mayer, Head of U.S. Compliance, Vice President, Legal, argenx, US, Inc Establishing a workplace culture that values ethics and integrity shows employees that fraud isn’t an acceptable route to personal or professional success. In this session, leading in-house, defense and relator’s counsel will discuss: • The compatibility of behavioral ethics and fraud prevention • The behavioral and ethical circumstances that facilitate fraud in a company • How to address and change workplace culture behaviors for the better 6:00 | Conference Concludes

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WHO ATTENDS y General Counsel y Chief Legal Counsel y Assistant General Counsel y In-House Counsel

y Outside Counsel specializing in: » False Claims Act

» Government Contracts

» Fraud

» Healthcare

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» Life Sciences

» White Collar Crime

» Financial Services

y Litigators

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