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Day 1 - Friday, September 24, 2021

9:30
Opening Remarks from the Co-Chairs

Savaria B. Harris
Senior Counsel, Regulatory Law
Johnson & Johnson

Paul Kaufman
Vice President, Office of Legal Affairs
Northwell Health

9:45

Fireside Chat with the SIGPR

What Every Life Sciences & Healthcare Company Needs to Know About CARES Act Oversight

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

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

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

  • 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

60 Minutes on Legislation, Politics and Policy

The Future of FCA Enforcement Under the Biden Administration: Compliance Strategies for Life Sciences & Healthcare

David N. Kelley
Partner
Dechert LLP

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

Matthew Feeley
Assistant United States Attorney
Southern District of Florida

Courtney Gilligan Saleski
Partner
DLA Piper

  • 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
    • Evaluating fraudulent or unproven medical products
  • Adapting to Medicare requirements announced by CMS
  • 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
  • Analyzing the expanded reach of FCA enforcement efforts now including opioid marketers and pharmacies

11:30
The Enforcers Speak: The Impact of Recent DOJ Policy Changes and Federal Caselaw on the Government’s Evaluation of a Qui Tam Action on Life Sciences or Healthcare Sectors

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

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

  • 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
  • Reviewing the effect of government declination on the first-to-file bar
  • Examining the developing case law regarding the standard to prove causation between and false statement and subsequent damages
  • Analyzing guidance for prosecutors when:
    • Investigating a life science or healthcare corporation’s compliance program
    • Deciding whether to award cooperation credit to defendants

12:30
1:1 Networking
12:40
Break
1:30

Spotlight on AKS and Stark Law

Part I: Manufacturer Speaker Programs, Sunshine Act Penalties and Off-Label Promotion

Galia Porat
Associate General Counsel
Teva Pharmaceuticals

Eric W. Sitarchuk
Partner
Morgan, Lewis & Bockius LLP

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

Hollie K. Foust
Deputy General Counsel
Cardinal Health

  • Reviewing the HHS OIG issued special fraud alert on manufacturer-sponsored 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 post-Medtronic

2:15

Spotlight on AKS and Stark Law

Part II: Telehealth, Electronic Health Records and Cybersecurity Related Fraud

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

3:00
Break
3:15
FCA Activity Surrounding Nursing Homes, Skilled Nursing Facilities and Hospice Care: Unwritten Lessons for Life Sciences & Healthcare Companies

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

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

Kenneth M. Abell
Partner
Abell Eskew Landau LLP

  • 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
CCO Roundtable: How to Reduce Risk by Leveraging Data

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)

  • Reviewing data mining and the use of data analysis in FCA enforcement
    • 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
Closing Remarks from the Co-Chairs