False Claims and Qui Tam Enforcement

Registration and Breakfast

Opening Remarks from the Conference Chairs

Tara Shewchuk
Global Chief Ethics & Compliance Officer
Medtronic

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

Julie Bracker
Partner
Bracker & Marcus LLC

A Year After the SCOTUS SuperValu Decision: Exploring the Impact of the Subjective Scienter Standard on File Strategy and Future Litigation

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

Eric W. Sitarchuk
Partner
Morgan, Lewis & Bockius LLP

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

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

Spotlight on Compliance: Revamping Your Third Party Due Diligence Checklist to Protect Against the FCA’s Expanding Reach

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

Moderator:

Tara Shewchuk
Global Chief Ethics & Compliance Officer
Medtronic

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 inter-agency collaboration
  • When do FCPA risks play into FCA risks (and vice versa)?

Morning Networking Break

The DOJ’s Civil Cyber Fraud Initiative in Action: The Latest Cross-Industry Trends and How Companies Can Become Compliant

Tirzah Lollar
Partner
Arnold & Porter

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

Brian Craig
Vice President & Assistant General Counsel
Science Applications International Corporation (SAIC)

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

Moderator:

Julie Bracker
Partner
Bracker & Marcus LLC

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

Networking Lunch

Government Enforcement and Investigative Priorities: Exclusive Roundtable

Ken Dieffenbach, CFE, CCEP
Deputy Assistant Inspector General for Investigations
U.S. Department of Energy

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

Brian Martens
Director of Strategic Projects and Initiatives
U.S. Department of Health and Human Services, Office of Inspector General

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

Crunching the Numbers: The Rise of Data Relators and DOJ Data Analytics to Identify Fraud

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

Afternoon Networking Break

Government Contracts Under the Microscope: Navigating Procurement Fraud and Mitigating Risk

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

Justin Chiarodo
Partner
Blank Rome LLP

Michael Gill
Assistant General Counsel & Director of Investigations
Huntington Ingalls Industries, Inc.
Former Criminal Chief, USAO, Eastern District of VA

Nkechi A. Kanu
Counsel
Crowell & Moring LLP

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

The Public-Private Partnership Between Relator’s Counsel and Government: Everything You Never Knew You Never Knew

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

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

Colette G. Mattzie
Partner
Phillips & Cohen LLP

Moderator:

Renée Brooker
Partner
Tycko & Zavareei LLP
Former Assistant Director, Civil Division, USDOJ

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

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?
   
   Moderated by: 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
   
   Moderated by: Patrick McCarthy, Senior Vice President, Managing General Counsel, Fluor Mission Solutions
   
   Life Sciences and Healthcare
   
   
3. How are attorneys adapting their arguments in light of the circuit splits on but-for
   causation between alleged kickbacks and the claim?
   
   Moderated by: Lisa Kutlin, Senior Compliance Counsel, Investigations, Pfizer
   
   
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)
   
   Moderated by: 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?
   
   Moderated by: 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?
   
   Moderated by: 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

Conference Adjourns

Registration and Breakfast

Welcome Back from the Conference Chairs

Tara Shewchuk
Global Chief Ethics & Compliance Officer
Medtronic

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

Julie Bracker
Partner
Bracker & Marcus LLC

Spotlight on Healthcare and Pharma

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

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

Krysten Rosen Moller
Partner
Covington & Burling LLP

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

Miriam Glaser Dauermann
Acting Assistant Chief, Criminal Division, Healthcare Fraud Unit
USAO, Eastern District of NY

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

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

Spotlight on Healthcare and Pharma

Part II: Countering Compliance Uncertainty in the Telehealth Rules and Managing Post-Pandemic Telehealth Fraud Risks

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

Jolie Apicella
Partner
Wiggin & Dana LLP
Former Chief, Civil Health Care Fraud, USAO, Eastern District of NY

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

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:

• 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

Morning Break

Pandemic Recovery Fraud: Special Interview

Michael Galdo
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

Conducting Effective Internal Investigations When the Whistleblower is an Employee: Best and Newest Practices

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
• 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

Networking Lunch

Keynote: U.S. Department of Justice

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

Lisa Kutlin
Senior Compliance Counsel, Investigations
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

John Vagelatos
Assistant United States Attorney, Criminal Division
USAO, Eastern District of NY

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

Afternoon Networking Break

From Prep to Verdict: Trial Advocacy Advice from Trial and Appellate Counsel

Maurice Bellan
Partner | Managing Partner Washington
Baker & McKenzie LLP

Jennifer Verkamp
Partner
Morgan Verkamp LLC

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

ETHICS

Demystifying Ethical E-Discovery and Privilege in FCA Internal and External Investigations

Lisa Podewils Korologos
Assistant United States Attorney, Criminal Division
USAO, Southern District of NY

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

Mary Inman
Partner
Constantine Cannon LLP

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

Conference Concludes