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Handouts - 2017 - National - Enforcement

Sunday, October 29 ( Pre-Conference)



Anatomy of False Claims Act Case

Moderator: Craig Holden, Shareholder, Baker Donelson

Amy Easton, Phillips and Cohen LLP

Tamara Forys, Senior Counsel, OIG-U.S. Department of HHS

Natalie Waites Priddy, Civil Fraud Branch, U.S. Department of Justice

  • The Investigation Phase: subpoenas/ CIDs, data analysis, witness interviews and more
  • The Negotiation Phase: initiation, ADR, scope of release, monetary and other issues
  • The Resolution Phase: settlement agreements, individual liability, CIAs/ OIG and relator issues

Presentation (2 slides/page)
Presentation (3 slides/page)



Health Information Privacy & Security: Recent Developments & Enforcement Actions

Joan Podleski, Chief Privacy Officer, Children’s Health Dallas

R. Brett Short, Chief Compliance Officer, UK Healthcare, University of Kentucky

  • Review of 2016 and 2017 OCR enforcement actions
  • Trends to watch: what are the common themes in recent actions
  • Breaking news: what are the new issues that have been cited recently

Presentation (2 slides/page)
Presentation (3 slides/page)



Are We Ineffective at Assessing Compliance Program Effectiveness or Are Industry and Government Using Different Standards?

Thomas Beimers, Partner, Hogan Lovells

Judy A. Ringholz, VP of Compliance & Ethics and Chief Compliance Officer, Jackson Health System

Sara Kay Wheeler, Partner, King & Spalding

Laura Ellis, Senior Counsel, OIG – U.S. Department of HHS

  • The essential elements of an effective compliance program including the more recent focus on Individual accountability and its impact on compliance programs
  • Potential consequences for failing to have an effective compliance program
  • Strategic considerations to help attendees better understand if their program would satisfy these new industry expectations and ideas for enhancement, if warranted

Presentation (2 slides/page)
Presentation (3 slides/page)



Litigating a False Claims Act Case

John T. Boese, Of Counsel, Fried, Frank, Harris, Shriver & Jacobson LLP

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

Latour Lafferty, Partner, Holland & Knight LLP

David Wiseman, Civil Fraud Branch, U.S. Department of Justice

  • Common motions in FCA litigation
  • Proving/disproving falsity, knowledge and damages after Escobar
  • Discovery and trial issues in intervened vs. non-intervened cases
  • Role of individual defendants in FCA litigation

Handout 1
Handout 2



Kickback and Stark Law Developments

Daniel Melvin, Partner, McDermott Will & Emery, LLP

Charles Oppenheim, Partner, Hooper Lundy Bookman, PC

Kevin McAnaney, Law Office of Kevin G. McAnaney

  • Overview of key statutory terms and exceptions for anti-kickback statute
  • Overview of key statutory terms and exceptions for Stark law
  • Overview of enforcement trends and recent noteworthy decisions

Presentation (2 slides/page)
Presentation (3 slides/page)



Enforcement, Compliance and Long Term Care: Home Health, Hospice and Nursing Homes

Nicole Martin, Director of Quality & Compliance, Samaritan Healthcare & Hospice

Adam Schwartz, Shareholder, Carlton Fields

Eva Gunasekera, Of Counsel, Finch McCranie LLP

  • OIG Workplan for 2017
  • Identified vulnerabilities for hospice providers
  • Quality of care issues

Presentation (2 slides/page)
Presentation (3 slides/page)



Negotiating False Claims Act Settlements

Charles Graybow, Assistant U.S. Attorney, U.S. Attorney’s Office-District of NJ

Jack Wenik, Partner, Epstein Becker & Green PC

Andrea Treese Berlin, Senior Counsel, OIG-U.S. Department of HHS

  • Current trends in False Claims Act settlements, including the effect of Universal Health Services v. United States ex rel. Escobar
  • Negotiating False Claims Act settlements including special situations such as reverse false claims
  • Drafting False Claims Act settlement agreements from the defense and government perspectives

Presentation (2 slides/page)
Presentation (3 slides/page)



Handling a Criminal Healthcare Fraud Case

Michael E. Clark, Special Counsel, Duane Morris LLP

Ralph Caccia, Partner, Wiley Rein LLP

Sally B. Molloy, Trial Attorney, Fraud Section, U.S. Department of Justice, Criminal Division

  • Investigative interviewing techniques
  • The use of Big Data
  • Emerging trends in criminal healthcare fraud

Slides are not available for distribution



Options and Strategies for Self-Disclosure: Why, When, Where and How?

Gabriel Imperato, Managing Partner, Broad and Cassel

Tony Maida, Partner, McDermott Will & Emery

Tamar Terzian, Senior Counsel, Administrative and Civil Remedies Branch, Office of Counsel to the Inspector General, U.S. Department of Health and Human Services

  • Is it voluntary or obligated?
  • Report and repayment rule
  • Resolution and releases

Presentation (2 slides/page)
Presentation (3 slides/page)



Avoiding Criminal and Civil Liabilities for Overpayments

David Glaser, Shareholder, Fredrikson & Byron PA

Sanford Teplitzky, Shareholder, Baker Donelson

  • Analyze why insufficient documentation doesn’t create a Medicare overpayment
  • Discuss strategies for handling audits to private payors
  • Examine common mistakes made when making a voluntary disclosure and suggest language for refund letters

Presentation (2 slides/page)
Presentation (3 slides/page)



Federal Administrative Sanctions: Exclusion & Civil Money Penalities

Edgar Bueno, Partner, Morris, Manning & Martin LLP

David Blank, Senior Counsel, OIG-U.S. Department of HHS

  • Affirmative Exclusions and CMPs - Enforcement Trends and Recent Settlements
  • Intersection with DOJ Investigations, CMS Audits, and Other Parallel Proceedings
  • Compliance Measures that Mitigate Against Liability

Presentation (2 slides/page)
Presentation (3 slides/page)



Damages & Liability to Federal Health Programs

Tim Renjilian, FTI Consulting

R. Joseph Burby IV, Partner, Bryan Cave

  • Discuss key concepts in the calculation of damages related to Federal health care programs
  • Address ongoing issues and debates involving damage calculations
  • Analyze newly emerging damage theories from recent settlements and what their implications are

Presentation (2 slides/page)
Presentation (3 slides/page)


Monday, October 30 


Department of Justice Update on Criminal Health Care Fraud Enforcement

Joseph Beemsterboer, Chief, Healthcare Fraud Unit, Fraud Section, Criminal Division, U.S. Department of Justice

Slides are not available for distribution



Department of Justice Update on Civil False Claims Act Enforcement

Michael Granston, Director, Commercial Litigation Branch, Fraud Section, Civil Division, U.S. Department of Justice

No presentation available



The Future of Enforcement: Ten Issues to Bring Home for Your 2018 Compliance Program

James G. Sheehan, Chief, Charities Bureau, NY Attorney General

Presentation (2 slides/page)
Presentation (3 slides/page)

Handout 1
Handout 2
Handout 3




Best Practices for Life Sciences Companies Repeatedly Targeted in Whistleblower Lawsuits

Gejaa Gobena, Partner, Hogan Lovells LLP

David Schumacher, Partner, Hooper Lundy & Bookman, PC

Matthew L. Stennes, Senior Legal Director of Healthcare Law & Investigations, Medtronic, Inc.

  • The panel will explore the hows, whys, and consequences that large life sciences companies face as they are targeted by whistleblowers who see deep pockets
  • We’ll focus on each of those three areas, and how strong compliance programs and appropriate remediation can act as a shield against the normal consequences of being considered a repeat player or “recidivist” due to multiple investigations

Presentation (2 slides/page)
Presentation (3 slides/page)



Tips and Tools for Mitigating CMS Enforcement Actions

Sean McKenna, Shareholder, Greenberg Traurig, LLP

David Wright, Director, Survey and Certification Group, CMS

  • Recognizing red flags that lead to enforcement matters
  • Using transparency and data to enhance the quality of Medicare providers
  • Overview of best practices, tools, and resources to limit surveys and avoid enforcement actions

Presentation 1 (2 slides/page)
Presentation 1 (3 slides/page)

Presentation 2 (2 slides/page)
Presentation 2 (3 slides/page)



Managing the Consultant Relationship in the Landscape of Self-Disclosure and FCA Investigations

Lester J. Perling, Partner, Broad and Cassel

Jean Acevedo, Senior Consultant, Acevedo Consulting Inc

  • Attendees will learn strategies for managing consultant relationships in the context of auditing for possible self-disclosure in order to attempt to preserve attorney client privilege
  • Attendees will learn how to determine when to bring in a consultant in a government investigation and how to manage that relationship
  • Attendees will learn how to utilize consultants in the context of a government investigation—dos and don’ts

Presentation (2 slides/page)
Presentation (3 slides/page)



Using Data and Statistics to Defend Against Health Care Enforcement

Christopher Haney, Managing Director, Forensus Group, LLC

Daniel M. Tardiff, Chief Legal Counsel, Walgreens Prime Strategic Alliance

  • Trends in the government’s use of data including statistical sampling and extrapolation
  • Affirmatively using your own, routinely gathered data to reduce exposure
  • Pairing data and statistical analyses with internal investigations

Presentation (2 slides/page)
Presentation (3 slides/page)



Conducting Internal AKS and Stark Investigations and Managing Resolution Risks

Joseph Hudzik, Counsel, Latham & Watkins, LLP

Alex Krouse, Attorney, Parkview Health

Steven W. Ortquist, Managing Director, Aegis Compliance & Ethics Center, LLP

  • Conducting appropriate internal investigations of AKS and Stark Law violations in an era new regulatory obligations and heightened enforcement activity
  • Managing disclosure and resolution challenges when disclosing noncompliance through the OIG and CMS protocols or directly to DOJ
  • Assessing the individual enforcement risk associated with self-disclosure

Presentation (2 slides/page)
Presentation (3 slides/page)



Best Practices for Internal Investigations

Hannah Levinson, Associate, Nelson Mullins Riley & Scarborough

Shachi Mankodi, Assistant General Counsel (Regulatory), Davita Medical Group

  • Responding to reports of potential non-compliance and setting up an investigation
  • Managing investigations internally and with outside counsel
  • Decision-making factors regarding potential corrective action and disclosures

Presentation (2 slides/page)
Presentation (3 slides/page)



An Ounce of Prevention: The Role of Compliance Programs in False Claims Act Investigations and Litigation

Scott Grubman, Partner, Chilivis, Cochran, Larkins & Bever

Lena Amanti, Assistant United States Attorney, U.S. Attorney’s Office, Northern District of Georgia

Renee Brooker, Of Counsel, Finch McCranie LLP

Lauren Marziani, Senior Counsel, OIG-U.S. Department of HHS

  • What the government looks for in a corporate compliance program, including guidance from the OIG regarding an effective compliance program
  • Tips on how to build and implement an effective compliance program, as well as common pitfalls to avoid
  • How corporate compliance programs play a role in government investigations and litigation, including how the government takes the existence and effectiveness of such a program into account in connection with such matters

Presentation (2 slides/page)
Presentation (3 slides/page)



Program Integrity in the State Medicaid Program: Best Practices for Coordination between the Compliance Officer and the State Medicaid Inspector General

Ryan T. Lipinski, CountyCare Compliance Officer, Cook County Health

Bradley Hart, Inspector General, State of Illinois Department of Healthcare and Family Services

Cathy Bodnar, Chief Compliance and Privacy Officer, Cook Ccounty Health and Hospital System

  • Overview of a State Medicaid Program Integrity Official’s Role in Preventing and Investigating Fraud, including coordination with State Medicaid Fraud Control Unit (MFCU). Presentation will highlighting priority areas for States in 2017
  • Examples of collaboration and coordination among State agencies and private sector partners, to strengthen the State’s efforts to address fraud, waste, and abuse in State-administered health care programs
  • Focus on Managed Care: How a Health Plan’s Special Investigation Unit can advance the State’s efforts in detecting aberrant billing patterns, conduct medical record reviews to ensure proper reimbursement and perform Provider education

Presentation (2 slides/page)
Presentation (3 slides/page)



Corporate Integrity Agreements: Living Under a CIA or using CIAs to Shape Legal/Compliance Programs

Robert A. Wade, Partner, Barnes & Thornburg, LLP

Laura Ellis, Senior Counsel, OIG-U.S. Department of HHS

  • Key elements of a CIA
  • Potential negotiable terms for a CIA
  • How to use recent CIAs to shape an organization’s legal/compliance functions

Presentation (2 slides/page)
Presentation (3 slides/page)



Responding to Government Investigations and Enforcement: Managing the Crisis and Communicating with Key Constituencies

Richard Westling, Epstein Becker & Green, P.C.

Molly Cate Jarrard, Phillips, Cate & Hancock, Chicago, IL

  • Coordinating your compliance and legal response with your communications strategy
  • What to tell the board, employees and medical providers
  • How and what to communicate with patients and the community

Presentation (2 slides/page)
Presentation (3 slides/page)



Three Competing Perspectives on Federal Health Care Enforcement Trends: Federal Prosecutor, In-House Counsel, Outside Counsel

Scott McBride, Partner, Lowenstein Sandler, LLP

Joseph Mack, Senior Compliance Counsel, Bayer U.S.

Bernard Cooney, Assistant United States Attorney, Office of the United States Attorney, District of New Jersey

  • Panel will discuss, from the competing perspectives of a federal prosecutor, in-house counsel, and outside counsel, current enforcement trends in the federal health care arena
  • Subjects will include First Amendment law in the off-label marketing space, as well as anti-kickback and related safe harbor developments
  • The panel will additionally explore other potential new hot enforcement areas

Presentation (2 slides/page)
Presentation (3 slides/page)



“Just Say No!” Avoiding Addiction Treatment Fraud and Abuse: What You Need to Know to Get and Stay in Compliance

Benton Curtis, Senior Counsel, Broad and Cassel

Zachary Rothenberg, Partner, Nelson Hardiman LLP

  • Current trends in Federal- and State- level fraud and abuse enforcement in the addiction treatment industry, and a realistic look at what those trends mean for compliance professionals in the industry.
  • “Hot topics” in enforcement for addiction treatment, including: (1) drug treatment marketing, (2) urine drug testing, (3) problematic relationships between outpatient programs and sober living facilities; (4) “step-down” billing, and (5) co-pay waivers.
  • Practical, “real world” strategies for getting (and staying!) in compliance.

Presentation (2 slides/page)
Presentation (3 slides/page)



Tuesday, October 31


Handling an Investigation in the Spotlight

Michael Horowitz, Inspector General, U.S. Department of Justice

Presentation (2 slides/page)
Presentation (3 slides/page)



CMS Update

Kimberly Brandt, Principal Deputy Administrator for Operations, CMS

Presentation (2 slides/page)
Presentation (3 slides/page)




Medicare Enrollment: Appeals, Compliance, and Collateral Consequences Under CMS’s Expanded Revocation Authority

Andrew Wachler, Partner, Wachler & Associates, PC

Richard R. Burris, Shareholder, Polsinelli PC

  • Identify key enrollment risk areas that all current and prospective providers need to be aware of, including the heightened reporting requirements and CMS’s expanded authority to deny or revoke provider enrollments under recent CMS rulemaking
  • Practical compliance tips for avoiding adverse enrollment actions, and strategic approaches for navigating through the enrollment appeals process
  • The interplay between provider enrollment, claims audits, and False Claims Act liability in today’s Medicare landscape

Presentation (2 slides/page)
Presentation (3 slides/page)




Complex Health Care Organization Relationships and the Impact of OCR HIPAA Enforcement Actions

Blaine A. Kerr, Chief Privacy Officer, Jackson Health System

Ryan Meade, Partner, Meade, Roach

Gregory V. Kerr, Director, Aegis Compliance & Ethics Center LLP

  • A discussion of Organized Health Care Arrangements (OHCA’s), Affiliated Covered Entities (ACE’s) and Hybrid Entities
  • How complex organizational changes may impact privacy investigations, breach liability responsibilities and the enforcement actions of the OCR
  • Methods to review and revise HIPAA strategies to more effectively address the complexities encountered by many health care organizations

Presentation (2 slides/page)
Presentation (3 slides/page)




Effective Compliance with I.M.P.A.C.T.™

Gurujodha Khalsa, Chief Deputy County Counsel, Kern County

Kristen Lilly, Healthcare Consultant, PYA

  • I.M.P.A.C.T is an acronym that stands for: Intention, Meditation, Projection, Action, Commitment and Trust
  • The communication and team building skills necessary to set Specific, Measurable, Achievable, Realistic, and Time-Bound Goals
  • Using breath meditation and visualization as a means to get the compliance team on the same page and working with “directional harmony”; using Affirmation and Visual Reminders to reinforce goals
  • Designing an action plan consistent with the Intention, Meditation, and Projection; nurturing consistency and commitment to achieve the stated goals of the team; refining communication and building rapport to enhance trust and build team efficacy

Presentation (2 slides/page)
Presentation (3 slides/page)





Your Company Has Been Served with a Civil Investigative Demand: Now What?

Candice M. Deisher, Assistant Attorney General, Virginia Attorney General’s Office

Marc S. Raspanti, Partner, Pietragallo, Gordon, Alfano, Bosick & Raspanti, LLP

  • What is a civil investigative demand and who has the power to issue one?
  • What does it mean if your company has received a civil investigative demand?
  • What to expect after receipt of a civil investigative demand and some best practice considerations when responding

Presentation (2 slides/page)
Presentation (3 slides/page)

Handout 1
Handout 2




Security & Cyber Risk: Breach & Compliance

Bob Chaput, CEO, Clearwater Compliance

Sheetal Sood, Senior Executive Corporate Compliance Officer, New York City Health + Hospitals

  • Clean the house: Cyber-hygiene to safeguard patient information and ensure patient safety
  • Practical tips on how to practice effective and good cyber-hygiene. Learn about current cybersecurity landscape in healthcare, including recent and emerging trends, and their impact on compliance programs
  • Learn how to conduct a comprehensive risk identification and assessment exercise that covers all connected devices
  • Connecting the dots: Patient Information and Patient Safety—yes, they are connected

Presentation (2 slides/page)
Presentation (3 slides/page)




Clinical Trial Fraud & Enforcement

F. Lisa Murtha,Senior Managing Director, Ankura Consulting, Inc.

Kelly M. Willenberg, CEO, Kelly Willenberg & Associates

  • Preparation tools for an audit or investigation
  • Analyzing your risks for non compliance
  • Validating poor record keeping and lack of training

Presentation (2 slides/page)
Presentation (3 slides/page)




The Government Official & Chief Compliance Officer: Learned Experiences on Proactive Inititatives to Mitigate and Minimize Risk

Bret S. Bissey, Healthcare Compliance Executive

Alec Alexander, Partner, Breazeale, Sachse & Wilson

  • The negotiation activities which surround a CIA or Settlement Agreement can be stressful and potentially result in an agreement which contains flaws or inaccuracies. What elements is the government looking for? Who is best to negotiate for providers?
  • Every investigation/settlement has a history of something that could have been done differently or maybe in a more proactive manner. Hear from the speakers about applicable cases, settlements and investigations where proactive actions were missed
  • Board Governance is a key element of a compliance program. Learn of proactive activities that can be taken to demonstrate that this is working as recommended by OIG-DHHS including making sure the Board is always involved and aware of their obligations

Presentation (2 slides/page)
Presentation (3 slides/page)




State Civil Enforcement Updates

George Codding Sr., Assistant Attorney General, State of Colorado

Kathleen Von Hoene, Bureau Chief, MFCU-Complex Civil Enforcement Bureau, Office of the Attorney General, State of FL

  • Understand what areas and entities are being investigated by the states
  • Learn how the recent Escobar “materiality” decision is influencing state enforcement
  • Discuss what you can do to avoid being the object of unwanted attention from state enforcement authorities

Presentation (2 slides/page)
Presentation (3 slides/page)




Ask the Stark Law Professionals: Q & A Session

Bob A. Wade, Partner, Barnes & Thornburg LLP

Lester J. Perling, Partner, Broad and Cassel

Kevin McAnaney, Law Office of Kevin McAnaney

  • Very brief overview of the Stark Law
  • Respond to pre-submitted & live questions regarding case examples of the application of the Stark Law

Presentation (2 slides/page)
Presentation (3 slides/page)


Wednesday, November 1 


Whistleblower Case Study

Gabriel Imperato, Managing Partner, Broad and Cassel

Lesley Ann Skillen, Attorney, Getnick & Getnick LLP

  • Whistleblowers; Who are they and why do they file Qui Tam cases?
  • Are there strategies for health care organizations to manage the whistleblower risk and what are the key features?
  • How important is an organizational anti-retaliation policy and what are important tips for compliance program effectiveness?

Presentation (2 slides/page)
Presentation (3 slides/page)



Managed Care Fraud Enforcement & Compliance

Christopher Horan, VP Compliance Investigations, Wellcare Health Plan, Inc.

David Leviss, Partner, O’Melveny & Meyers LLP

  • Recent False Claims Act enforcement trends affecting managed care organizations
  • Navigating regulatory challenges in a managed care environment
  • Role of an SIU (or Compliance Dept.) in managed care

Presentation (2 slides/page)
Presentation (3 slides/page)



Opioid Crisis: Drug Diversion & Enforcement

Gary Cantrell, Deputy Inspector General for Investigations, OIG HHS

Michael Cohen DHSc, JD, PA-C, Operations Officer, HHS OIG Office of Investigations

  • Overview of the HHS’s work to protect beneficiaries from opioid abuse and diversion
  • Criminal enforcement case studies
  • Highlights from OIG’s analysis of Medicare spending on opioids

No presentation available



Criminal & Civil Enforcement & Compound Pharamacies

Daniel Bernstein, AUSA, United States Attorney’s Office, Southern District of Florida

Samuel Sheldon, Partner, Quinn Emanuel

  • Government enforcement lawyers will describe the magnitude, scope and nature of the compounding pharmacy fraud scheme against the Tricare program from 2013–2015
  • Prosecutors and defense lawyers will offer their perspective on several different schemes that have been aggressively investigated by the government including doctor kickbacks in the form of research fees and medical director fees, patient kickbacks in the form of clinical research participation fees, and various medical necessity issues
  • Prosecutors and defense lawyers will discuss enforcement trends, defense theories, and recent cases

Presentation (2 slides/page)
Presentation (3 slides/page)



Medical Necessity and the False Claims Act: Investigating, Proving, and Defending FCA Cases Involving Issues of Medical Necessity

JD Thomas, Waller

Jeffrey Dickstein, Partner, Phillips & Cohen LLP

Robert McAuliffe, Assistant Director, U.S. Department of Justice, Civil Division, Commercial Litigation Branch (Frauds)

  • Medical necessity, from the validity of inpatient admissions to the amount of rehab provided to patients, increasingly dominates FCA cases. This panel of experienced attorneys from the government, defense, and relator’s bar will examine these issues
  • We will consider legal issues around medical necessity cases, including post-Escobar questions of materiality, as well as regulations typically in play in common questions of medical necessity
  • We will discuss factual issues that arise in medical necessity cases, including investigating, proving, and defending against allegations of the lack of medical necessity, as well as designing and implementing statistically valid medical reviews

Presentation (2 slides/page)
Presentation (3 slides/page)



Private Payer Activities in Addressing Fraud and Abuse and Compliance Issues in the Health Care Industry

Lou Saccoccio, CEO NHCAA (Moderator)

Rick Munson, Vice President, Investigations, UnitedHealthcare

Nicholas Messuri, VP Fraud Prevention & Recovery, DentaQuest

Thomas J. Daly, Acting Unit Chief, U.S. Dept. of Justice, Federal Bureau of Investigation

  • The analytical and other tools being used by private payers and government agencies to identify and prevent fraud, along with the importance of pre-pay review and the elimination of fraudsters from the system
  • The critical role that private-public partnerships are playing to increase information sharing and collaboration between private payers and law enforcement in the fight against health care fraud
  • The close alignment between private payer SIUs and Compliance to ensure there is oversight of FWA programs that meet the expectations of regulators

Presentation (2 slides/page)