12th Annual Advanced Forum on False Claims and Qui Tam Enforcement - DS

EARN CLE CREDITS

12th Annual Advanced Forum on

False Claims and Qui Tam Enforcement January 27 – 28, 2025

New York City Bar Association, New York, NY

Distinguished CHAIRS:

Lisa Kutlin

Senior Compliance Counsel, Investigations Pfizer (Former Assistant U.S. Attorney, Eastern District of New York)

Mary Inman

Partner Whistleblower Partners

Roderick Thomas Partner Wiley Rein LLP

Supporting Sponsors

REGISTER NOW

Hear Directly from

GOVERNMENT ENFORCERS:

Exclusive

ONE-ON-ONE INTERVIEW WITH:

Jacob Foster

Michael Granston

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

Zachary Cunha

US Attorney for the District of Rhode Island United States Attorneys’ Office

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

Meet Leading Industry DECISION-MAKERS FROM: • BAE Systems, Inc. • Bristol-Myers Squibb • GE Aerospace

Brian Miller

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

Associate Sponsors

AmericanConference.com/FalseClaims • 888 224 2480

• Lockheed Martin Corporation • Northwell Health • Pfizer

Premium Exhibitor

Part of C5 Group’s LEGAL GLOBAL SERIES

F

iscal Year 2023 marked the fifteenth straight year of recoveries exceeding $2 billion, hitting a record $2.68.

Over $1.8 billion of these recoveries come from the healthcare industry alone. With an emphasis on data from enforcers and relators, and incentive programs encouraging whistleblowers, the FCA remains a steadfast tool that promises to only get stronger.

A record in

government recoveries over $2 billion. The announcement of new Whistleblower Incentive Programs. The rise of data driven analysis and artificial intelligence.

Increased liability for third parties. These are the fundamentals of the False Claims Act landscape for 2025.

DOJ has continued to utilize data across the enforcement landscape, diving deeper into pandemic-related fraud and Medicare advantage matters, identifying outliers to indicate likely fraud. Additionally, whistleblowers and relators filed 712 qui tam cases in 2023, with settlements and judgements exceeding $2.3 billion. With the introduction of the DOJ’s new Corporate Whistleblower Awards Pilot Program, the intersection of the Anti-Kickback Statute and the FCA, and rigorous investigations into the minutiae of fraud, enforcement efforts have never been more powerful.

Considering judicial questions surrounding knowledge standards for liability, cybersecurity adequacy, and the constitutional validity of the qui tam provision, the future of the False Claims Act landscape remains uncertain.

Attending ACI’s 12th Annual Advanced Forum on False Claims and Qui Tam Enforcement will provide the clarity you need in this evolving environment. Join us live in NYC to hear directly from government enforcers, cross-industry compliance and investigations counsel, and top attorneys from both the defense and relators’ bar on how to prepare for the next wave of FCA enforcement and avoid becoming a target of government action.

DOJ False Claims Act Recoveries in FY2023 543

hands-helping

Totaling

EQUALS 2.68B $

Settlements

FCA RECOVERIES BY SECTOR

BY DOLLARS RECOVERED

$6B $5B $4B

Repeat-alt $

1.8B

$

Recovered from the healthcare industry

Gavel 712

Qui tam suits filed in 2022

$3B $2B $1B

balance-scale 2.3B $

Recovered from qui tam lawsuits

2010

2011

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

square Healthcare

square Defense

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square Other

CHAIRS

Lisa Kutlin

Senior Compliance Counsel, Investigations Pfizer (Former Assistant U.S. Attorney, Eastern District of New York)

“ The diverse perspectives of panelists and participants make this my go-to FCA conference every year.”

Mary Inman

Partner Whistleblower Partners

“ [This] is the definitive, must-attend event for all False Claims Act practitioners.”

Roderick Thomas Partner Wiley Rein LLP

“ This is a great opportunity to exchange ideas and build relationships within this diverse FCA bar.”

GOVERNMENT Michael Granston

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

Zachary Cunha

US Attorney for the District of Rhode Island United States Attorneys’ Office

Erek Barron

US Attorney for the District of Maryland United States Attorneys’ Office

Brian LaMacchia

Chief, Affirmative Civil Enforcement Unit, District of Massachussets United States Attorney’s Office

Charlene Keller Fullmer

Deputy Chief, Civil Division, Eastern District of Pennsylvania United States Attorney’s Office

Clarissa Pinheiro

Jake M. Shields

Former Senior Trial Counsel, Civil Division, Fraud Section U.S. Department of Justice

Jillian Estes

Jacob Foster

Lyndsay A. Gorton

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

Sara Vann

Senior Assistant Attorney General, Medicaid Fraud Division Office of the Attorney General of the State of Georgia

Jill Brenner

Special Assistant Attorney General, Medicaid Fraud Control Unit Office of the New York State Attorney General

Peter S. Hyun

Former Chief for the Enforcement Bureau Federal Communications Commission

Partner Crowell & Moring LLP

Rebecca J. Hillyer

Partner Morgan, Lewis & Blockius LLP

Jody Hunt

General Counsel Samford University (Former Assistant Attorney General, Civil Division, U.S. Department of Justice)

Paul Kaufman

Vice President, Office of Legal Affairs Northwell Health

Amy Kossak

ESTEEMED SPEAKERS

Partner, Ropes & Gray LLP (Former Senior Trial Counsel, Civil Division, U.S. Department of Justice)

Jolie Apicella

Hamsa Mahendranathan

Jenelle Beavers

Enu Mainigi

Partner Wiggin and Dana LLP Managing Director Alvarez & Marsal Holdings, LLC (Former Trial Counsel, Civil Division, U.S. Department of Justice)

Maurice Bellan

Partner Baker & McKenzie LLP

Heather Bloom

Partner Whistleblower Partners LLP Partner Williams & Connolly LLP

Rebecca C. Martin Partner Jones Day

Brian Tully McLaughlin Partner Crowell & Moring LLP

Director and Associate General Counsel for Litigation and Compliance Lockheed Martin

Ann McRitchie

Julie Bracker

Partner Blank Rome LLP

Partner Bracker & Marcus LLC

Renée Brooker

Partner Tycko & Zavareei LLP

Matthew Cannon

Shareholder Greenberg Traurig, LLP.

Assistant US Attorney for the Southern District of Florida United States Attorneys’ Office

Justin A. Chiarodo

Richard Hayes

Jay Dewald

Chief Civil Division U.S. Attorney’s Office, Eastern District of New York

Partner Morgan Verkamp LLC

Partner Blank Rome LLP

Assistant General Counsel Amentum

Luke Meier

Lisa Noller

Partner Foley & Lardner LLP

Jaime Raich

Executive Counsel, Global Investigations, GE Aerospace (Former Assistant U.S. Attorney, Southern District of Florida)

Christian D. Sheehan

Partner Arnold & Porter Kaye Scholer LLP

Partner | Head of Healthcare Investigations Norton Rose Fulbright

Jennifer M. Wollenberg

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

Jonathan Diesenhaus

Adam Yoffie

Amanda Riedel

Alice M. Eldridge

Brian Miller

Partner, Litigation, Arbitration, and Employment Hogan Lovells

Director, COVID-19 Fraud Senior Vice-President & Task Force General Counsel REGISTEREnforcement NOW AmericanConference.com/FalseClaims • 888 224 2480 U.S. Department of Justice BAE Systems, Inc.

Partner Morgan, Lewis & Blockius LLP Senior Corporate Counsel – Litigation & Government Investigations Bristol-Myers Squibb Company (Former U.S. Trial Attorney, Part of C5Strike Group’s Health Care Fraud Force, LEGAL of GLOBAL U.S. Department Justice,SERIES District of Columbia)

Day 1 – January 27, 2025 7:15am

Registration and Breakfast

8:15am

Opening Remarks from the Conference Chairs Lisa Kutlin

Senior Compliance Counsel, Investigations Pfizer (Former Assistant U.S. Attorney, Eastern District of New York)

8:30am

Mary Inman

Roderick Thomas

Partner Whistleblower Partners

Partner Wiley Rein LLP

Navigating High-Stakes: Supreme Court Rulings Reshaping FCA and Qui Tam Enforcement

With heightened attention from the Supreme Court, the False Claims Act landscape is undergoing shifts that demand scrutiny. In this conference opening session, participants will hear critical insights into the most significant Supreme Court and lower court rulings transforming the practice.

Topics of discussion will include: • Examining Supreme Court and lower court decisions in cases impacting the enforcement of the False Claims Act including » U.S. ex rel. Schutte v. SuperValu Inc. » Universal Health Services, Inc. v. United States ex rel. Escobar

Partner, Litigation, Arbitration, and Employment Hogan Lovells

Enu Mainigi

Partner Williams & Connolly LLP

Hamsa Mahendranathan

Partner Whistleblower Partners LLP

» U.S. ex rel. Polansky v. Executive Health Resources Inc. » Wisconsin Bell, Inc. v. United States, ex rel. Todd Heath • Discussing the impact of Loper Bright Enterprises v. Raimondo on FCA enforcement and litigation

9:45am

Jonathan Diesenhaus

Brian Tully McLaughlin Partner Crowell & Moring LLP

FIRESIDE CHAT: Insider Perspectives on FCA Enforcement and Policy

Join Jody Hunt and Michael Granston for an exclusive discussion offering insider perspectives on the latest trends and enforcement priorities under the False Claims Act. This candid conversation will provide invaluable insights into policy shifts, DOJ strategies, and what lies ahead for litigation.

Michael Granston

Deputy Assistant Attorney General, Civil Division U.S. Department of Justice INTERVIEWED BY

Jody Hunt

General Counsel, Samford University (Former Assistant Attorney General, Civil Division, U.S. Department of Justice)

10:15am

Morning Networking Break

10:45am

Targeted for Action: Unpacking DOJ’s Enforcement Priorities and Focus Areas

This session will explore the evolving enforcement strategies at DOJ. Topics of discussion will include: • Reviewing DOJ’s efforts to uncover Pandemic related fraud • Understanding the impact of DOJ’s new data-driven enforcement efforts on investigations • Exploring DOJ’s recent focus on telehealth companies in the healthcare and life sciences industries, and what this means for traditional healthcare companies implementing new technologies • Predicting new focus areas and enforcement priorities under the new administration

Zachary Cunha

US Attorney for the District of Rhode Island United States Attorneys’ Office

Julie Bracker

Partner Bracker & Marcus LLC

4 | LINKEDIN Financial Services: Legal, Regulatory, Insurance and Compliance Professionals

Amy Kossak

Partner Ropes & Gray LLP (Former Senior Trial Counsel, Civil Division, U.S. Department of Justice)

Day 1 – January 27, 2025 11:45am

Whistleblowers Awards on the Rise: DOJ’s Pilot Program and the Industry-Wide Impacts

This session will explore DOJ’s new Corporate Whistleblower Awards Pilot Program and the far-reaching impact on compliance, enforcement, and legal strategies. Topics of discussion will include: • Unveiling DOJ’s new program and its potential to expose corporate fraud • Exploring how SEC, CFTC, and FinCEN programs will amplify compliance and enforcement efforts

Jacob Foster

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

• Examining the impact on defense and relator strategies

Partner Tycko & Zavareei LLP

12:45pm

Networking Lunch

1:45pm

Five Years of Pandemic Fraud Recovery in Review

• Assessing the work of the DOJ Task Force on COVID-19 Fraud Enforcement • Revisiting recent pandemic fraud cases involving False Claims Act enforcement in the District of Massachusetts, such as the Kabbage case • Examining pandemic fraud enforcement in the District of Maryland • Reviewing the 5-year tenure of the Office of the Special Inspector General for Pandemic Recovery

2:45pm

Erek Barron

Brian Miller

Brian LaMacchia

Amanda Riedel

US Attorney for the District of Maryland United States Attorneys’ Office Chief, Affirmative Civil Enforcement Unit, District of Massachussets United States Attorney’s Office

Special Inspector General for Pandemic Recovery U.S. Department of Treasury Director, COVID-19 Fraud Enforcement Task Force U.S. Department of Justice

When to Disclose: A Cost Benefit Analysis of How and When to Voluntarily Self-Disclose

This session will detail the intricacies of self-disclosure credit programs from DOJ, OIG, and HHS, explaining how companies can leverage these programs to mitigate risk. We will look closer at how to determine if, and when, disclosure should be made. Topics of discussion will include: • Understanding how these voluntary self-disclosure programs operate and interact • Learning the criteria for receiving credits when voluntarily disclosing potential violations • Exploring the importance of Voluntary Self-Disclosure (VSD) in compliance strategies • Maximizing the benefits to protect your organization • Untangling the impact of self-disclosure on internal company structures » Concerns regarding fiduciary duty to stakeholders • Assessing when VSD is appropriate for your client

Alice M. Eldridge

Senior Vice-President & General Counsel BAE Systems, Inc.

Lisa Noller

Partner Foley & Lardner LLP

Charlene Keller Fullmer

Deputy Chief, Civil Division, Eastern District of Pennsylvania United States Attorney’s Office

3:45pm

Afternoon Networking Break

4:00pm

Challenging the Constitutionality of the False Claims Act’s Qui Tam Provisions

This session will explore the constitutional challenges to the FCA’s qui tam provisions, including key rulings and dissenting opinions that question its fate. Topics of discussion will include: • Examining U.S. ex rel. Polansky v. Executive Health Resources Inc. and Justice Clarence Thomas’s dissent on (c)(2)(A) • Analyzing the impact of lower court cases • Discussing the transforming landscape with cases like Zafirov v. Florida Medical Associates LLC and United States v. ExacTech Inc.

Champagne Roundtables

5:00pm 6:00pm

Executive Counsel, Global Investigations GE Aerospace (Former Assistant U.S. Attorney, Southern District of Florida)

Renée Brooker

• Predicting the effects of the program on risk mitigation and legal strategies

In 2020, in the wake of the COVID-19 Pandemic, a Special Inspector General for Pandemic Recovery position was created by CARES Act. The office and position are scheduled to sunset on March 28, 2025. Join Special Inspector General Brian Miller as he speaks with government officials from across the enforcement landscape on:

Jaime Raich

Conference Adjourns

REGISTER NOW

AmericanConference.com/FalseClaims • 888 224 2480

Matthew Cannon

Shareholder Greenberg Traurig, LLP.

Lyndsay A. Gorton

Partner Crowell & Moring LLP

Ann McRitchie

Assistant General Counsel Amentum

Christian D. Sheehan

Partner Arnold & Porter Kaye Scholer LLP Part of C5 Group’s LEGAL GLOBAL SERIES

Day 2 – January 28, 2025 7:30am

Registration and Breakfast

8:30am

Welcome Back from the Conference Chairs

8:45am

Staying Above Board: Spotlight on In-House Cooperation and Compliance

Maintaining a strong compliance practice that protects your company, fosters good DOJ relations, and avoids fraud requires robust internal systems. To succeed, you must track compliance rigorously and ensure full cooperation with agency requests – actions that can save or cost millions. During this in-house led roundtable, topics of discussion will include: • Maintaining and utilizing data analytics to ensure consistent compliance and safeguard against potential self-incrimination

Director and Associate General Counsel for Litigation and Compliance Lockheed Martin

Paul Kaufman

» How to defend a case in which a company’s data may indicate outliers without providing the complete picture » How to prosecute a case in which a company’s data is self-incriminating without the capacity to comprehensively analyze said data • Identifying how and when to look further into a whistleblower complaint • Analyzing the intersection between internal data analysis and the scienter standard to avoid constructive knowledge of fraud • Understanding how to comply sufficiently and promptly with a CID, Subpoena, or Civil Request to avoid unnecessary delay and ensure cooperation with investigative action

9:45am

Heather Bloom

Vice President, Office of Legal Affairs Northwell Health

Adam Yoffie

Senior Corporate Counsel – Litigation & Government Investigations Bristol-Myers Squibb Company (Former U.S. Trial Attorney, Health Care Fraud Strike Force, U.S. Department of Justice, District of Columbia)

The Anatomy of an FCA Trial: How, When, and Where to Get Off the Ride

This practical session will explore key milestones in an FCA case where strategic decisions can save time and money, and protect your reputation. Topics of discussion will include:

Roderick Thomas

• Identifying exit strategies at every stage of government intervention

Partner Wiley Rein LLP

• Determining whether to settle with the government or take a case to trial after the government has intervened

Peter S. Hyun

• Establishing strategies for settlements to limit expense and prepare for success should there be additional civil or criminal trials

Former Chief for the Enforcement Bureau Federal Communications Commission

10:45am

Morning Networking break

11:00am

The Intersection of Fraud: How the Anti-Kickback Statute Fuels FCA Cases

This session will examine the connection between the AKS and the FCA, exploring how violations of one can trigger liabilities under the other.

Topics of discussion will include: • Analyzing the 2010 ACA amendments that ties AKS violations to FCA claims • Examining the growing body of case law and the implication for legal strategy, including Grenfield, Cairns, Martin, Teva, and Regeneron • Understanding the circuit split and its implications for future risk mitigation

12:00pm

Richard Hayes

Jay Dewald

Maurice Bellan

Rebecca J. Hillyer

Chief Civil Division U.S. Attorney’s Office, Eastern District of New York Partner Baker & McKenzie LLP

Networking Lunch

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Partner | Head of Healthcare Investigations Norton Rose Fulbright

Partner Morgan, Lewis & Blockius LLP

Day 2 – January 28, 2025 1:00pm

Spotlight on Healthcare: Navigating Telehealth, AI, and Emerging Risks

This panel will identify new focus areas in healthcare fraud enforcement, with special attention paid to emerging technologies including Telehealth platforms, data analytics, and AI. Topics of discussion will include: • Exploring FDA compliance requirements in the evolving healthcare landscape • Utilizing data analytics and AI to strengthen compliance and prevent fraud risks • Examining cases like United States ex rel. Doe v. eviCore Healthcare MSI and Shire Pharmaceuticals to understand emerging enforcement priorities • Identifying insights from healthcare that can inform compliance strategies in other industries adopting new technologies

2:00pm

Clarissa Pinheiro

Managing Director Alvarez & Marsal Holdings, LLC (Former Trial Counsel, Civil Division, U.S. Department of Justice)

Lisa Kutlin

Senior Compliance Counsel, Investigations Pfizer (Former Assistant U.S. Attorney, Eastern District of New York)

Rebecca C. Martin Partner Jones Day

State and Federal Enforcement: Understanding the Similarities and Distinctions Between Investigations at Every Level

With over 30 states enforcing FCA statutes alongside federal provisions, enforcement is growing in both arenas. This session will provide an in-depth exploration of the evolving interplay between state and federal efforts, highlighting key trends, challenges, and opportunities for navigating this increasingly complex enforcement landscape.

Jennifer M. Wollenberg

Partner Morgan, Lewis & Blockius LLP

Sara Vann

Senior Assistant Attorney General, Medicaid Fraud Division Office of the Attorney General of the State of Georgia

3:00pm

Afternoon Networking Break

3:15pm

Expanding the Scope: Private Equity Liability in False Claims Act Cases

Recently the DOJ has emphasized holding third parties accountable when they have caused the submission of false claims. These “third parties” increasingly include private equity firms, particularly in the healthcare industry. Topics of discussion will include: • When do private equity companies become liable for fraudulent acts by the companies in which they invest?

• How do private equity companies ensure safety from liability?

• How do companies and their funders work together to remain diligent?

• Lessons learned from PE cases that can be applied across other industries facing FCA scrutiny

4:00pm

Jenelle Beavers

Assistant US Attorney for the Southern District of Florida United States Attorneys’ Office

Jake M. Shields

Former Senior Trial Counsel, Civil Division, Fraud Section U.S. Department of Justice

Jolie Apicella

Partner Wiggin and Dana LLP

Mary Inman

Partner Whistleblower Partners

ETHICS – From AI to Gag Orders: Ethical Concerns in the False Claims and Qui Tam Environment

• Identifying potential ethical pitfalls when utilizing AI for document and data review • Maintaining privilege while gaining efficiency through new digital technologies • Avoiding possible ethical violations when utilizing gag orders in litigation and settlement strategies

Jillian Estes

Partner Morgan Verkamp LLC

Luke Meier

Partner Blank Rome LLP

5:00pm

Conference concludes

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