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Day 1 - Wednesday, June 22, 2022

7:45
Registration and Breakfast
8:45
Opening Remarks from Co Chairs
9:00
A Special Interview with Michael Granston, Deputy Assistant Attorney General, Civil Division
9:45
Materiality, Scienter, and Falsity: Clarity or More Confusion?
11:00
Networking Break
11:30
Cybersecurity Fraud: The New Frontier in FCA and Qui Tam Enforcement?
12:30
Advanced Advocacy in FCA and Qui Tam Claims: The Defense Perspective
1:30
Networking Lunch
2:45
Drafting, Pleading, and Litigating: The Relator’s Counsel Perspective
3:45
Afternoon break
4:00
Optimal Strategies for Resolving FCA Matters and Qui Tam Lawsuits
5:30
Networking Cocktail Reception

Day 2 - Thursday, June 23, 2022

7:45
Registration and Breakfast
8:45
Opening Remarks from Co-Chairs
9:00
The Who, What, Where, and When of Pandemic Fund Recovery
10:00
Critical Developments Involving the Stark Law, the Anti-Kickback Statute, and Medicare Advantage Program
11:00
Networking Break
11:30
Understanding DOJ’s Enforcement Priorities: Private Equity, Telehealth, Electronic Health Records (EHRs) and Opioids
12:30
Crunching the Numbers: The Use of Data Analytics and Statistical Sampling to Identify and Prosecute Fraud
1:30
Networking Lunch
3:00
Government Procurement Fraud and the FCA: An In-Depth Exploration of Unique Legal Considerations and Enforcement Trends
4:00
Networking Break
4:30
Fireside Chat: A Primer on Tax FCA and Qui Tam
5:00

ETHICS

Proactively Combating the Potential for Fraud: Behavioral Ethics and Fraud Prevention
6:00
Conference Concludes

Day 1 - Wednesday, June 22, 2022

7:45
Registration and Breakfast
8:45
Opening Remarks from 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.

9:00
A Special Interview with Michael Granston, Deputy Assistant Attorney General, Civil Division

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

Joseph “Jody” Hunt
Partner
Alston & Bird LLP
(Former Assistant Attorney General, United States Department of Justice)

9:45
Materiality, Scienter, and Falsity: Clarity or More Confusion?

Michael A. Rogoff
Partner
Arnold & Porter Kaye Scholer LLP

Maryana Zubok
Assistant General Counsel, Litigation
Pro Bono Lead, Legal Division

Pfizer Inc.

Arunabha Bhoumik
Executive Director, Assistant General Counsel | Head, General Litigation and Government Investigations.
Regeneron Pharmaceuticals, Inc.

Lynn Neils
Partner
Foley Hoag

Carrie Sarhangi Love
partner
Armstrong Teasdale 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:

  • Legal developments based on recent and important federal court decisions concerning materiality, scienter, and falsity
  • Strategizing venue selection and pleadings in light of widening Circuit splits on dismissal authority and changing government policies
  • Extrapolating the impact of policy changes and federal court decisions on litigation strategy

11:00
Networking Break
11:30
Cybersecurity Fraud: The New Frontier in FCA and Qui Tam Enforcement?

Richard Hayes
Deputy Chief, Civil Division
United States Attorney's Office, Eastern District of New York

Renée 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

Eric Sitarchuk
Partner
Morgan Lewis

Brendan Stewart
Of Counsel
Gibson Dunn LLP

Jason Mehta
Partner
Bradley Arant Boult Cummings LLP

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:

  • Reviewing the different types of subpoenas and civil investigative demands (CIDs) and negotiating their scope with DOJ
  • Establishing positive dialogue with government attorneys and considering the value of cooperation credit
  • Seeking declination and dismissal
  • 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

1:30
Networking Lunch
2:45
Drafting, Pleading, and Litigating: The Relator’s Counsel Perspective

Julie K. Bracker
Founding Partner
Bracker & Marcus LLC

Robert Vogel
Partner
Vogel, Slade and Goldstein LLP

Jeb White
President & 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
4:00
Optimal Strategies for Resolving FCA Matters and Qui Tam Lawsuits

Robert M. Thomas, Jr
Managing Member, Co-Founder
Whistleblower Law Collaborative LLC

Joseph Mack
Senior Assistant General Counsel, Compliance and Investigations
Bayer US LLC

Emily Derr
Director, Healthcare Counsel
Alkermes

Allison O’Neil
Partner
Locke Lorde

This session is devoted to the last mile of FCA and qui tam proceedings. Leading in-house, defense and relator’s counsel will discuss:

  • Negotiating a favorable resolution (damages, multipliers, and cooperation credit)
  • Satellite negotiations: relator’s share and fees
  • 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
Networking Cocktail Reception

Day 2 - Thursday, June 23, 2022

7:45
Registration and Breakfast
8:45
Opening Remarks from Co-Chairs
9:00
The Who, What, Where, and When of Pandemic Fund Recovery

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

Philip Selden
First Assistant United States Attorney
United States Attorney’s Office, District of Maryland

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

Moderator:

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

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:

  • Reviewing a Main Street Lending Program and Paycheck Protection Program (PPP) fraud case by the U.S. Attorneys who prosecuted them
  • Assessing the Health and Human Services (HHS) approach to Provider Relief Fund (PRF) fraud enforcement
  • Hearing the government’s priorities in terms of recovering pandemic-related 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 Anti-Kickback Statute, and Medicare Advantage Program

Hamsa Mahendranathan
Partner
Constantine Cannon

Ryan McCarthy
Partner
Morgan Lewis

Adam Yoffie
Senior Corporate Counsel, Litigation & Government Investigations
Bristol Myers Squibb

Galia Porat
Associate General Counsel
Teva Pharmaceuticals

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:

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

Medicare Advantage Program
  • Risk Adjustment Diagnosis Coding
  • Trends in Medicare Advantage litigation

11:00
Networking Break
11:30
Understanding DOJ’s Enforcement Priorities: Private Equity, Telehealth, Electronic Health Records (EHRs) and Opioids

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

Jay Dewald
Head of Healthcare Investigations, US
Norton Rose Fullbright

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

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

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

Lon R. Leavitt
Partner
Halunen Law

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
3:00
Government Procurement Fraud and the FCA: An In-Depth Exploration of Unique Legal Considerations and Enforcement Trends

James Perrine
Assistant General Counsel
Huntington Ingalls Industries, Inc

Roderick L. Thomas
Partner
Wiley Rein LLP

Patrick McCarthy
Vice President Law
Managing General Counsel

Fluor Mission Solutions

Daniel Chudd
Corporate Director Division Counsel
Northrop Grumman

Jaime Raich
Executive Counsel, Global Investigations
General Electric Company

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:

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

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