False Claims and Qui Tam Summit for Life Sciences and Healthcare - DS by C5Group

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False Claims and Qui Tam Summit for Life Sciences and Healthcare Calendar-alt September 24, 2021 (EDT) Virtual Conference

Reducing Risk Amid the Expanding Reach of the FCA

Distinguished Co-Chairs: Savaria B. Harris Senior Counsel, Regulatory Law Johnson & Johnson “This life sciences and healthcarespecific conference will provide a tremendous annual opportunity for leading attorneys from the government, relator and defense bar to gather, present and discuss trends and issues concerning the False Claims Act in a structured, intimate, and informal setting.”

Paul Kaufman Vice President, Office of Legal Affairs Northwell Health “This conference is going to cover many hot topics in the health care enforcement field, and I am looking forward to hearing from the numerous current and former high-level government enforcement attorneys that are scheduled to speak on those topics.”

Featuring a Special Pandemic Recovery Update with: Brian D. Miller Special Inspector General for Pandemic Recovery (SIGPR)) U.S. Department of The Treasury

Hear Directly from Government Enforcers: Jolie Apicella Chief, Civil Health Care Fraud, United States Attorney’s Office Eastern District of New York

Sean R. Keveney Deputy General Counsel U.S. Department of Health and Human Services

Jacob M. Bergman Deputy Chief, Civil Frauds Unit United States Attorney’s Office Southern District of New York

Lisa D. Kutlin Assistant U.S. Attorney Eastern District of New York

Matthew Feeley Special Assistant U.S. Attorney U.S. Department of Justice Charlene Keller Fullmer Deputy Civil Affirmative Chief, U.S. Attorney’s Office Eastern District of Pennsylvania Rachael A. Honig Acting U.S. Attorney District of New Jersey

AmericanConference.com/FalseClaimsHealthcare • 888 224 2480

Joseph A. Marutollo Assistant United States Attorney, Acting Chief, Civil Division, United States Attorney’s Office Eastern District of New York Sean O’Donnell Acting Inspector General U.S. Department of Defense

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

There is a sustained and aggressive use of the False Claims Act by the government and Qui Tam relators alike in the Life Sciences and Healthcare Sectors. Although they are companion industries, life sciences and healthcare often operate in individual silos. However, these industries are now bonding over being trapped in the cross hairs of FCA activity. Stakeholders for each industry now often work hand in glove. The unwritten lessons that each industry can learn from the other can foster collaboration and a commitment to compliance. By all accounts, the trend for government initiated FCA actions is continuing to climb, leaving the life sciences and healthcare industries pondering:

» Will the FCA enforcement increase under the Biden Administration? » What can we expect for Fiscal ‘21? » Where will government enforcement priorities lie? » What can you do now to prepare for the next wave of FCA enforcement?

This dual industry-tailored summit will address the underlying controversies and challenges posed by the latest FCA activity. The forum will feature key stakeholders from the life sciences and healthcare communities, including senior government officials, industry executives and leading private practitioners for a meeting of the minds between the life sciences and healthcare. Join us for in-depth discussion and analyses of the latest guidance, initiatives, and enforcement statistics impacting the life sciences and healthcare industries as we analyze what each group can learn from the other.

HANDSHAKE WHO SHOULD ATTEND ĉ General Counsel ĉ Chief Legal Counsel ĉ Chief Compliance Officer ĉ Assistant General Counsel ĉ In-House Counsel ĉ Litigators ĉ Outside Counsel specializing in: • • • • • • •

Corporate Compliance False Claims Act Fraud and Abuse Healthcare Life Sciences Litigation White Collar Crime

Media Partners:

Testimonials from Our Co-Chairs:

PLAY

2 | #FalseClaimsHealthcare twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

Distinguished Faculty CO-CHAIRS: Savaria B. Harris Senior Counsel, Regulatory Law Johnson & Johnson

Paul Kaufman Vice President, Office of Legal Affairs Northwell Health

GOVERNMENT: Jolie Apicella Chief, Civil Health Care Fraud, United States Attorney’s Office Eastern District of New York Jacob M. Bergman Deputy Chief, Civil Frauds Unit United States Attorney’s Office Southern District of New York Matthew Feeley Special Assistant U.S. Attorney U.S. Department of Justice

Charlene Keller Fullmer Deputy Civil Affirmative Chief, U.S. Attorney’s Office Eastern District of Pennsylvania Rachael A. Honig Acting U.S. Attorney District of New Jersey Sean R. Keveney Deputy General Counsel U.S. Department of Health and Human Services Lisa D. Kutlin Assistant U.S. Attorney Eastern District of New York

Joseph A. Marutollo Assistant United States Attorney, Acting Chief, Civil Division, United States Attorney’s Office Eastern District of New York Brian D. Miller Special Inspector General for Pandemic Recovery (SIGPR) U.S. Department of The Treasury Sean O’Donnell Acting Inspector General U.S. Department of Defense

LAW FIRM AND IN-HOUSE COUNSEL: Kenneth M. Abell Partner Abell Eskew Landau LLP

David N. Kelley Partner Dechert LLP

Zachary Coseglia Managing Principal and Head of Innovation Ropes & Gray LLP

Tara Shewchuk Deputy Chief Ethics & Compliance Officer Medtronic

Rebecca C. Martin Partner Jones Day

Eric W. Sitarchuk Partner Morgan, Lewis & Bockius LLP

(Former Assistant General Counsel, Head of Global Compliance Monitoring, Pfizer)

Jacob T. Elberg Associate Professor Seton Hall University School of Law

(Former Chief, Health Care & Government Fraud Unit, U.S. Attorney’s Office, District of New Jersey)

Gejaa T. Gobena Partner Hogan Lovells Hollie K. Foust Deputy General Counsel Cardinal Health

Galia Porat Associate General Counsel Teva Pharmaceuticals Courtney Gilligan Saleski Partner DLA Piper Robert S. Salcido Partner Akin Gump Strauss Hauer & Feld LLP Gregg Shapiro Attorney Newman & Shapiro

Scott D. Stein Partner Sidley Austin LLP A. Brendan Stewart Partner Gibson Dunn LLP (Former Assistant Chief Fraud Section, Criminal Division, U.S. Department of Justice) Robert L. Vogel Partner Vogel, Slade & Goldstein, LLP

(Former Chief, Affirmative Civil Enforcement Unit, U.S. Attorney’s Office, District of Massachusetts)

AmericanConference.com/FalseClaimsHealthcare • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

CONFERENCE AGENDA

Friday, September 24, 2021 (EDT) 9:30 AM

» Evaluating fraudulent or unproven medical products

Co-Chairs’ Opening Remarks

• Adapting to Medicare requirements announced by CMS

microphone-alt Savaria B. Harris, Senior Counsel, Regulatory Law,

• Anticipating an increase in FCA violations related to FDA’s Good Manufacturing

• Preparing for the government’s interest in ensuring PE firms provide oversight of the acquisition of life sciences and healthcare corporations

Johnson & Johnson

Paul Kaufman, Vice President, Office of Legal Affairs, Northwell Health

• Analyzing the expanded reach of FCA enforcement efforts now including opioid marketers and pharmacies

9:45 AM FIRESIDE CHAT WITH SIGPR

What Every Life Sciences and Healthcare Company Needs to Know About CARES Act Oversight microphone-alt Brian D. Miller, Special Inspector General for Pandemic Recovery (SIGPR), U.S. Department of The Treasury

11:30 AM

The Enforcers Speak: The Impact of Recent DOJ Policy Changes and Federal Caselaw on the Government’s Evaluation of a Qui Tam Action in the Life Sciences or Healthcare Sectors

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

microphone-alt Charlene Keller Fullmer, Deputy Civil Affirmative Chief,

Sean R. Keveney, Deputy General Counsel, U.S. Department of Health and Human Services

Rachael A. Honig, Acting U.S. Attorney, District of New Jersey

Joseph A. Marutollo, Assistant United States Attorney, Acting Chief, Civil Division, United States Attorney’s Office, Eastern District of New York

Jacob M. Bergman, Deputy Chief, Civil Frauds Unit, United States Attorney’s Office, Southern District of New York

Moderator: Scott D. Stein, Partner, Sidley Austin LLP

• Understanding what life science and healthcare companies need to know about CARES Act oversight • Analyzing how the SIGPR approaches the critical task of protecting taxpayer money • Reviewing challenges and successes experienced while building an agency from the ground up 10:30 AM 60 MINUTES ON LEGISLATION, POLITICS AND POLICY

The Future of FCA Enforcement Under the Biden Administration: Compliance Strategies for Life Sciences and Healthcare microphone-alt Matthew Feeley, Special Assistant U.S. Attorney,

U.S. Attorney’s Office, Eastern District of Pennsylvania

• Reviewing the expanding regulatory authority of federal and state prosecutors • Assessing the impact intervention has on relator’s eventual recoveries • Understanding §(C)(2)(A) of the FCA, which grants the attorney general the authority to dismiss qui tam actions over a relator’s objection

U.S. Department of Justice

• Reviewing the effect of government declination on the first-to-file bar

David N. Kelley, Partner, Dechert LLP

• Examining the developing case law regarding the standard to prove causation between and false statement and subsequent damages

Courtney Gilligan Saleski, Partner, DLA Piper

Gregg Shapiro, Attorney, Newman & Shapiro (Former Chief, Affirmative Civil Enforcement Unit, U.S. Attorney’s Office, District of Massachusetts)

• Analyzing guidance for prosecutors when: » Investigating a life science or healthcare corporation’s compliance program » Deciding whether to award cooperation credit to defendants

• Analyzing the Biden Administration’s enforcement policies and priorities of FCA violations by life sciences and healthcare companies » Anticipating and predicting trends in enforcement from DOJ and FDA » Preparing for the increase in FCA violations related to FDA’s Good Manufacturing Practice requirements (cGMP) • Reviewing state and federal investigations and prosecutions stemming from COVID-19 related fraud

12:30 PM

1:1 Networking 12:40 PM Break

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4 | #FalseClaimsHealthcare twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

Spotlight on AKS and Stark Law 1:30 PM PART I

Manufacturer Speaker Programs, Sunshine Act Penalties, and Off-Label Promotion microphone-alt Galia Porat, Associate General Counsel, Teva Pharmaceuticals

3:15 PM

FCA Activity Surrounding Nursing Homes, Skilled Nursing Facilities, and Hospice Care: Unwritten Lessons for Life Sciences and Healthcare Companies

Eric W. Sitarchuk, Partner, Morgan, Lewis & Bockius LLP

Robert L. Vogel, Partner, Vogel, Slade & Goldstein, LLP

microphone-alt Lisa D. Kutlin, Assistant U.S. Attorney, Eastern District of New York

Hollie K. Foust, Deputy General Counsel, Cardinal Health

Robert S. Salcido, Partner, Akin Gump Strauss Hauer & Feld LLP

Kenneth M. Abell, Partner, Abell Eskew Landau LLP

• Reviewing the HHS OIG issued special fraud alert on manufacturersponsored speaker programs and the implications for industry post-pandemic » Bolstering compliance controls for selecting speakers and attendees • Reviewing the manner in which promotional review committees evaluate materials to ensure compliance with DOJ’s evolving approach to enforcing off-label promotion cases • Appreciating the expansion of the Sunshine Act requiring reporting of payments or transfers of value made » Preparing for increased interest in parallel settlements between DOJ and CMS under the Sunshine Act’s Open Payments program 2:15 PM PART II

Telehealth, Electronic Health Records, and Cybersecurity Related Fraud

• Identifying areas of high-risk exposure • Analyzing how enforcement priorities impact providers • Implementing best practices for minimizing risk • Understanding how mitigation tactics can be adapted by life sciences and healthcare companies 4:15 PM

CCO Roundtable: How to Reduce Risk by Leveraging Data microphone-alt Tara Shewchuk, Deputy Chief Ethics & Compliance Officer, Medtronic

Zachary Coseglia, Managing Principal and Head of Innovation, Ropes & Gray LLP, (Former Assistant General Counsel, Head of Global Compliance Monitoring, Pfizer)

Moderator: Jacob T. Elberg, Associate Professor, Seton Hall University School of Law (Former Chief, Health Care & Government Fraud Unit, U.S. Attorney’s Office, District of New Jersey)

microphone-alt Jolie Apicella, Chief, Civil Health Care Fraud, United States Attorney’s Office, Eastern District of New York

Gejaa T. Gobena, Partner, Hogan Lovells

Rebecca C. Martin, Partner, Jones Day

A. Brendan Stewart, Partner, Gibson Dunn LLP (Former Assistant Chief Fraud Section, Criminal Division, U.S. Department of Justice)

• Preparing for increased enforcement stemming from the dramatic expansion of telemedicine during the pandemic • Implementing best practices and requirements for conducting effective risk analysis • Identifying risks and compliance considerations related to data privacy

» How relators and government are using data in FCA cases • Learning how to monitor and mitigate risk by leveraging data » Understanding your data and how to use it as a sword and a shield to detect and defend fraud » Incorporating data analytics into compliance programs • Analyzing data to identify outliers and deviations inconsistent with accepted policies 5:00 PM

3:00 PM Break

Closing Remarks from the Co-Chairs

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• Reviewing data mining and the use of data analysis in FCA enforcement

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Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

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9 th Annual Advance Forum on:

False Claims and Qui Tam Enforcement January 31 – February 1, 2022 | New York, NY

AmericanConference.com/FalseClaimsHealthcare • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES