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

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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

Hear Directly from GOVERNMENT ENFORCERS:

Jacob Foster

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

Brian Miller

Special Inspector General for Pandemic Recovery

U.S. Department of Treasury

Exclusive

ONE-ON-ONE INTERVIEW WITH:

Michael Granston

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

• Lockheed Martin Corporation

• Northwell Health

• Pfizer

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.

Fiscal 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

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.

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

Assistant US Attorney for the Southern District of Florida

United States Attorneys’ Office

Richard Hayes

Chief Civil Division

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

Brian Miller

Special Inspector General for Pandemic Recovery

U.S. Department of Treasury

Amanda Riedel

Director, COVID-19 Fraud Enforcement Task Force

U.S. Department of Justice

Jacob Foster

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

ESTEEMED SPEAKERS

Jolie Apicella Partner

Wiggin and Dana LLP

Jenelle Beavers

Managing Director Alvarez & Marsal Holdings, LLC

Maurice Bellan Partner

Baker & McKenzie LLP

Heather Bloom Director and Associate General Counsel for Litigation and Compliance

Lockheed Martin

Julie Bracker Partner Bracker & Marcus LLC

Matthew Cannon Shareholder Greenberg Traurig, LLP.

Justin A. Chiarodo Partner Blank Rome LLP

Jay Dewald Partner | Head of Healthcare Investigations Norton Rose Fulbright

Jonathan Diesenhaus Partner, Litigation, Arbitration, and Employment Hogan Lovells

Alice M. Eldridge

Senior Vice-President & General Counsel

BAE Systems, Inc.

Jillian Estes Partner

Morgan Verkamp LLC

Lyndsay A. Gorton Counsel 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

John Kokkinen

Senior Associate General Counsel – Optum Litigation

UnitedHealth Group

Former Assistant United States Attorney, Criminal Health Care Fraud Coordinator, U.S. Department of Justice

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

Enu Mainigi Partner

Williams & Connolly LLP

Brian Tully McLaughlin Partner

Crowell & Moring LLP

Ann McRitchie Assistant General Counsel Amentum

Luke Meier Partner Blank Rome LLP

Lisa Noller Partner Foley & Lardner LLP

Jaime Raich

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

Tejinder Singh Partner Sparacino PLLC

Christian D. Sheehan Partner

Arnold & Porter Kaye Scholer LLP

Jennifer M. Wollenberg Partner

Morgan, Lewis & Blockius LLP

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)

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 Navigating

Mary Inman Partner Whistleblower Partners

Roderick Thomas Partner Wiley Rein LLP

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

» 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

• Revisiting the “Brand Memorandum” in the wake of Loper

» Assessing how Loper has shifted the application of the memo in DOJ FCA dismissals

9:45am FIRESIDE

Jonathan Diesenhaus Partner, Litigation, Arbitration, and Employment Hogan Lovells

Enu Mainigi Partner

Williams & Connolly LLP

Tejinder Singh Partner

Sparacino PLLC

Brian Tully McLaughlin Partner

Crowell & Moring LLP

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

Amy Kossak Partner Ropes & Gray LLP

(Former Senior Trial Counsel, Civil Division, U.S. Department of Justice)

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

• Examining the impact on defense and relator strategies

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

12:45pm Networking Lunch

1:45pm

Five Years of Pandemic Fraud Recovery in Review

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:

• 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

Jacob Foster

Principal Assistant Chief, National Rapid Response Strike Force, Fraud Section, Criminal Division

U.S. Department of Justice

Jaime Raich

Executive Counsel, Global Investigations

GE Aerospace

(Former Assistant U.S. Attorney, Southern District of Florida)

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

Brian Miller

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

Amanda Riedel 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

3:45pm Afternoon Networking Break

4:00pm Challenging

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

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.

5:00pm Champagne Roundtables

6:00pm Conference Adjourns

Matthew Cannon Shareholder

Greenberg Traurig, LLP.

Lyndsay A. Gorton Counsel Crowell & Moring LLP

Ann McRitchie

Assistant General Counsel Amentum

Christian D. Sheehan Partner

Arnold & Porter Kaye Scholer LLP

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

» 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 The Anatomy

of an FCA Trial: How, When, and Where

Heather Bloom

Director and Associate General Counsel for Litigation and Compliance

Lockheed Martin

Paul Kaufman

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)

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:

• Identifying exit strategies at every stage of government intervention

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

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

10:45am Morning Networking break

Roderick Thomas Partner

Wiley Rein LLP

John Kokkinen

Senior Associate General Counsel –Optum Litigation

UnitedHealth Group

Former Assistant United States Attorney, Criminal Health Care Fraud Coordinator, U.S. Department of Justice

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 Networking Lunch

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

Maurice Bellan Partner Baker & McKenzie LLP

Jay Dewald Partner | Head of Healthcare Investigations

Norton Rose Fulbright

Rebecca J. Hillyer Partner

Morgan, Lewis & Blockius LLP

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 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.

3:00pm Afternoon Networking Break

Clarissa Pinheiro

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

Lisa Kutlin

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

Jenelle Beavers

Managing Director Alvarez & Marsal Holdings, LLC

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

3:15pm 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

Jolie Apicella Partner Wiggin and Dana LLP

Mary Inman Partner Whistleblower Partners

4:00pm 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

EARN CLE CREDITS

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

For more information on ACI’s CLE process, visit: www.AmericanConference.com/Accreditation/CLE

Upcoming Events

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April 30 – May 1, 2025

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For over 40 years, C5 Group has provided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities. Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

VENUE

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 False Claims”.

HOTEL: Sofitel New York

ADDRESS: 45 West 44th Street

RESERVATIONS: Anna.Li@Sofitel.com or 212-782-3015

Please note that the guest room block cut-off date is December 27, 2024. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.

BOOK NOW

If you are unable to attend for any reason, you will have the

or

by January 17, 2025.

Contact our Customer Service Representatives:

Conference Institute G.Dounis@AmericanConference.com 1 212 352 3220 x7536

Use Registration Code: B00-999-GDS25

D.Manganiello@AmericanConference.com 1 212 352 3220 x5464 Use Registration Code: B00-999-DMO25

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