Agenda

Sunday, November 3

  • 09:00 AM - 10:30 AM
    Breakout Sessions
    #P01
    P1: Anatomy of a False Claims Act Case Katherine Lauer, Partner, Latham & Watkins, LLP Colin Huntley, Assistant Director, Commercial Litigation Branch, Fraud Section, Civil Division, U.S. DOJ Madeline Bainer, Senior Counsel, HHS-OIG
    • 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
    General Compliance
    #P02
    P2: Corporate Integrity Agreements: The Role of an Independent Review Organization (IRO) Steven Ortquist, Founder & Principal, Arete Compliance Solutions, LLC Glennon Moyers, Partner, KPMG LLP Amanda Copsey, ACRB Senior Counsel, Office of the Inspector General, US Department of Health and Human Services
    • Why do CIAs include an IRO? Frequently utilized review requirements
    • How have the roles and obligations of IRO been modified in recent years? What is behind the modifications?
    • Working with your IRO: Keys to a Successful IRO engagement
    General Compliance
    #P03
    P3: Navigating Enforcement Action, Investigations, and Settlements Anne Daly, Chief Compliance & Integrity Officer, Children's Hospital of Chicago Medical Center Christina Villa, Compliance Audit Coordinator, Adventist Health Ana-Cristina Navarro, Chief Compliance Officer, Shasta Community Health Center
    • This session will provide an overview, through a case study, of how an organization can have an adverse event lead them down the path of government surveys and formal enforcement actions on multiple levels, including a 195 item Systems Improvement Agree
    • Illustrate how a compliance team can, and should, assist in facilitating the planning and actions needed to not only overhaul a Health Care Organization’s (HCO) policies and training, but also to support the change in culture needed to sustain
    • Provide tools and methods for supporting the organization wide efforts, as well as lessons learned and mechanisms to help prevent your organization from having to navigate the choppy waters of a formal enforcement action
    General Compliance
  • 09:00 AM - 12:15 PM
    Pre Conference AM Pre Conference
  • 10:30 AM - 10:45 AM
    Networking Break Coffee & Hot Tea available
  • 10:45 AM - 12:15 PM
    Breakout Sessions
    #P04
    P4: Litigating a False Claims Act Case John Boese, Of Counsel, Fried, Frank, Harris, Shriver & Jacobson LLP Robert Vogel, Partner, Vogel, Slade & Goldstein, LLP Latour "LT" Lafferty, Partner, Holland & Knight Patrick Klein, Senior Trial Counsel, 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
    • Escobar-related discovery from the government regarding claims payment
    General Compliance
    #P05
    P5: Anti-Kickback Developments Tony Maida, Partner, McDermott Will & Emery Jillian Sparks, Senior Counsel, Industry Guidance Branch, U.S. Department of Health and Human Services, Office of Counsel to the Inspector General Sally Molloy, Chief, Strategy, Policy and Training Unit, U.S. Department of Justice, Criminal Division, Fraud Section

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  • Discussion of the recent OIG notice of proposed rule-making on value-based payments and regulatory burden reduction
  • Overview of recent anti-kickback enforcement actions and settlements
  • Review of the new all-payor kickback statute, Eliminating Kickbacks in Recovery Act of 2018 (EKRA)
  • Insights on how these developments impact your compliance program and strategies to mitigate risk

General Compliance
#P06
P6: Managed Care Enforcement and Compliance Kay Mesia, Principal, Two International Rose Dunn, Chief Operating Officer, First Class Solutions, Inc.
  • FDR enforcement in a Medicare Advantage Plan: Compliance process and oversight
  • RADV expectations of Medicare Advantage for claims data accuracy
  • Deficiency remediation
General Compliance
  • 12:15 PM - 01:30 PM
    Lunch (On Your Own)
  • 01:30 PM - 03:00 PM
    Breakout Sessions
    #P07
    P7: Negotiating False Claims Act Settlements and Mediation Jack Wenik, Partner, Epstein Becker & Green PC Janice Symchych, Mediator and Arbitrator, JAMS Sean O'Connell, Counsel, Hunton Andrews Kurth Laura Laemmle-Weidenfeld, Partner, Jones Day
    • Latest developments in False Claims Act settlements, including new DOJ policies and the effect of Universal Health Services v. United States ex rel. Escobar
    • Negotiating False Claims Act settlements including corporate and individual settlements
    • Drafting False Claims Act settlement agreements from the defense and government perspectives
    General Compliance
    #P08
    P8: Handling a Criminal Healthcare Fraud Case Richard Westling, Member, Epstein Becker & Green, P.C. Ralph Caccia, Partner, Wiley Rein LLP Amy Markopoulos, Counsel to the Chief, Healthcare Fraud Unit, U.S. DOJ
    • The role of data in criminal cases
    • Emerging criminal enforcement trends
    • Responding to criminal investigations and prosecutions
    General Compliance
    #P09
    P9: Enforcement and Compliance for General Counsel and Compliance Officers John Kelly, Member, Bass, Berry & Sims PLC Lisa Adkins, Vice President Compliance/Chief Compliance Officer, Children's National Health Shannon Sumner, Principal/Chief Compliance Officer, PYA
    • Enforcement agencies, government regulators, and whistleblowers remain focused on pursing health care fraud and abuse matters placing compliance programs and legal counsel as the first lines of defense
    • With so much at risk, our panelists will provide guidance and advice about what is keeping them up at night from the different perspectives of in-house counsel, compliance officer, and outside counsel
    • The panelists will provide advice on best practices to minimize the identified risks and enhance both legal and compliance functions
    General Compliance
  • 01:30 PM - 04:45 PM
    Pre Conference PM
  • 03:00 PM - 03:15 PM
    Networking Break Coffee & Hot Tea available
  • 03:15 PM - 04:45 PM
    Breakout Sessions
    #P10
    P10: Cyber Security and Health Care Privacy Roy Wyman, Attorney, Nelson Mullins Broad and Cassel David Kessler, Public Sector Product Compliance Counsel, Verizon Marti Arvin, Executive Advisor, CynergisTek, Inc. Joseph Dickinson, Partner, Smith Anderson
    • Assessing current cyber security and privacy legal landscape and enforcement actions
    • erging technologies: Cyber security and privacy risks for healthcare-related entities
    • Addressing risks from supply chain and third-party vendors to help reduce enforcement risks
    General Compliance
    #P11
    P11: Federal Administrative Sanctions: Exclusions, Civil Money Penalties, and Case Update Kristin Carter, Sharehloder, Baker, Donelson, Bearman, Caldwell & Berkowitz, PC Michael Torrisi, Senior Counsel, Office of Counsel to the Insepctor General, U.S. D
    • Overview of HHS-OIG and CMS administrative enforcement tools and sanctions, including civil monetary penalties, exclusions, revocations, and suspensions
    • Trends, priorities, and updates in HHS-OIG enforcement and CMS program integrity actions
    • A review of recent federal administrative healthcare enforcement actions
    General Compliance
    #P12
    P12: Compliance, Repayment and Self-Disclosure Brian Bewley, Member, Bass Berry & Sims PLC David Fuchs, Senior Counsel, Office of Counsel to the IG, U.S. Department of Health and Human Services Heather Bokor, Senior Director of Compliance, University of Florida Health System Nicole Caucci, Deputy Branch Chief, OIG HHS
    • Discuss applicable rules and provider obligations to return a known overpayment
    • Discuss best practices in identifying, quantifying, and remedying an overpayment
    • Discuss options and considerations for remedying an overpayment for simple repayments and voluntary disclosures
    General Compliance
  • 04:45 PM - 06:15 PM
    Welcome Reception Join us for a networking reception with our Exhibitors. Light appetizers and beverages will be served.

    • Monday, November 4

    • 07:00 AM - 08:00 AM
      Continental Breakfast
    • 08:00 AM - 08:15 AM
      Opening Remarks Monday
    • 08:15 AM - 09:30 AM
      General Session: Government 1: Enforcement Panel Kirk Ogrosky, Partner, Arnold & Porter Alec Alexander, Deputy Administrator, CMS, Director, Center for Program Integrity, CMS David Tanay, Division Chief, Health Care Fraud Division, Michigan Department of Attorney General Gustav Eyler, Director, Consumer Protection Branch, U.S. Department of Justice Andy Mao, Acting Director, Civil Fraud Section, US Department of Justice Gregory Demske, Chief Counsel to the Inspector General, HHS-OIG Allan Medina, Assistant Chief, U.S. Department of Justice, Fraud Section, Criminal Division
      • Discussion of DOJ Criminal and Civil Enforcement Priorities
      • Discussion of OIG and CMS Enforcement Initiatives
      • Discussion of Medicaid Fraud Enforcement Priorities
    • 09:30 AM - 10:00 AM
      Networking Break Coffee & Hot Tea available
    • 10:00 AM - 11:00 AM
      Breakout Sessions
      #101
      101: Collateral Consequences to Audits and Adverse Enrollment Actions Richard Burris, Shareholder, Polsinelli PC Andrew Wachler, Partner, Wachler & Associates, P.C.
      • Discussion of interplay between provider enrollment, claims audits, and False Claims Act liability in today's Medicare landscape
      • Description of interplay between claim audits, such as Target Probe and Educate and UPIC, and adverse enrollment actions
      • Navigating key risk areas that all revoked or terminated Medicare providers need to be aware of, along with practical tips and proactive compliance measures to avoid common pitfalls, including self-audits under the 60-Day Rule
      General Compliance
      #102
      102: What Makes a Compliance Program "Effective"?" Thomas Beimers, Partner, Hogan Lovells Heather Bokor, Senior Director of Compliance, University of Florida Health System Felicia Heimer, Senior Counsel, Office of Counsel To the Inspector General, U. S.
      • Discuss new and historical published guidance on compliance programs, measuring effectiveness, and program evaluation
      • Discuss benchmarking and the use of industry enforcement activity and Corporate Integrity Agreement requirements in your program
      • Discuss tips for achieving effectiveness in your organization and the view from multiple vantage points
      General Compliance
      #103
      103: Due Diligence and Compliance Edgar Bueno, Partner, Morris Manning & Martin LLP Lindsey Lonergan, Deputy General Counsel, Navicent Health
      • Learn what is or is not a red flag
      • How to access Information while the government investigates or when a case is under seal
      • Setting expectations as the deal moves forward and how to have productive conversations with the other side
      General Compliance
    • 11:00 AM - 11:15 AM
      Networking Break Coffee & Hot Tea available
    • 11:15 AM - 12:15 PM
      Breakout Sessions
      #201
      201: Nurse Practitioners and Physician Assistants: Emerging Compliance Issues for Hospitals Carolyn Buppert, Attorney, Law Office of Carolyn Buppert Elizabeth Skinner, Regional Corp Responsibility Ofcr, AdventHealth
      • Compliance professionals must understand billing requirements when the rendering clinician is a nurse practitioner or physician assistant and when clinical work is shared with physicians
      • Hospitals should not allow their employed nurse practitioners and physician assistants to be utilized by self-employed physicians. It's a Stark Law problem
      • New state and CDC guidelines on prescribing opioids have opened up a new line of fraud cases involving nurse practitioners and physician assistants. Compliance professionals should have general knowledge of state and national guidelines for prescribing
      General Compliance
      #202
      202: Building an Effective Investigative Team Tamra Smith, Principal Compliance Specialist, Providence St. Joseph Health Mike Sandulak, Director of Investigations, Providence St. Joseph Health Matthew Tormey, Chief Compliance Officer, Ensemble Health Partners
      • Evaluation: Identifying goals, assessing the current program, leveraging internal resources, and defining roles/responsibilities and scope of work. Ensuring investigations are valuable (consistent, high quality), variable (adaptable), and visible.
      • Investigation program elements: Building the team (identifying the right investigators and partners, and developing the right knowledge and skills), assembling the critical tools for your investigation's program, and developing metrics to monitor progress
      • Communicating for success and sustainability: Delivering well-written and complete reports, demonstrating an effective investigations process to reporters and stakeholders, and obtaining buy-in from senior leaders, stakeholders, and your team
      General Compliance
      #203
      203: Privacy Breach Response Blaine Kerr, Chief Privacy Officer, Jackson Health System Greg Kerr, Chief Privacy Officer, Ensemble Health Partners
      • A discussion of the importance of being proactive about data security and how information security is a dynamic process that must assess risks to e-PHI on an ongoing basis
      • Strategic insights to navigate interaction with the media such that protected health information is not disclosed in an egregious way
      • Methods to assess when a Business Associate Agreement is necessary and the obligations of the business associate throughout the life cycle of PHI
      General Compliance
    • 12:15 PM - 01:15 PM
      Networking Lunch LAFAYETTE LUNCH BUFFET
    • soup of the day
    • fresh sliced artisan breads and butter
    • caesar salad, parmesan cheese, croutons **cheese on the side**
    • fresh mozzarella - prosciutto salad in basil vinaigrette
    • roasted cauliflower , roasted mushrooms, romesco dressing
    • braised chicken thighs in pumpkin seed sauce
    • salmon medallions, lentil ragout
    • succotash of Blue Ridge Farm vegetables
    • Israeli couscous
    • carrot cake
    • key lime pie
    • Royal Cup regular and decaffeinated coffee
  • 01:15 PM - 02:15 PM
    Breakout Sessions
    #301
    301: False Claims Act Liability in Post-Acute Care Claudia Reingruber, Shareholder, Saltmarsh, Cleaveland & Gund Latour "LT" Lafferty, Partner, Holland & Knight
    • A review of recent False Claims Act cases, both civil and criminal, and areas of governmental focus on post-acute providers, including nursing homes, home health agencies, and hospice providers
    • Challenges facing post-acute providers, including changes in payment systems giving rise to new compliance risks and claim audit initiatives
    • Current enforcement trends, including potential liability for both providers and corporate management - Designing and implementing strategies to minimize compliance risks, understanding the benefits of an effective compliance program, and using data to identify areas of payment vulnerability - Federal Sentencing Guidelines, recent interpretations and important considerations during a False Claims Act investigation
    General Compliance
    #302
    302: Risk Management for Compliance Officers Steven Ortquist, Founder & Principal, Arete Compliance Solutions, LLC Scott Grubman, Partner, Chilivis, Cochran, Larkins & Bever
    • How and when are compliance officers at risk? What guidance, enforcement actions and war stories tell us
    • Managing and mitigating risks: How can you protect yourself?
    • What to do if you run into a challenge
    General Compliance
    #303
    303: Privacy and Compliance, HIPAA State Law and GDPR Iliana Peters, Shareholder, Polsinelli, PC Uday Ali Pabrai, CEO, ecfirst
    • Examine the state of federal and state privacy and security priorities that will impact regulated entities in 2020, particularly regarding compliance and enforcement
    • Review key HIPAA and GDPR challenges that continue to impact organizations
    • Discuss the leveraging cybersecurity frameworks such as NIST CsF and HITRUST enhance entities’ compliance programs
    General Compliance
  • 02:15 PM - 02:45 PM
    Networking Break Snack along with Coffee, Hot Tea & Sodas available
  • 02:45 PM - 03:45 PM
    Breakout Sessions
    #401
    401: HHS Health Industry Cyber Security Practices - Managing Threats and Protecting Patients Erik Decker, CISO and Chief Privacy Officer, University of Chicago Hospitals Karen Greenhalgh, Managing Principal, Cyber Tygr
    • HHS convened over 150 cybersecurity officers, privacy experts, medical professionals, and healthcare industry leaders to strengthen the US Healthcare and Public Health cybersecurity posture. In January of 2019 this task group released voluntary guidance.
    • In easy to understand terms, learn the 5 cybersecurity threat vectors that are most impactful. Understand the 10 Best Practices, supported by HHS/OCR, for suggested mitigation strategies across small, medium and large organizations
    • Ensure your organization is focusing on the highest risk threats with appropriate control techniques, policies, and procedures. Templates and toolkits will quickly integrate this knowledge into effective compliance and risk management programs
    General Compliance
    #402
    402: Lessons from Stark Investigations David Glaser, Shareholder, Fredrikson & Byron PA Matthew Krueger, United States Attorney, Eastern District of Wisconsin
    • A US Attorney and defense lawyer discuss how cooperation between the government and defendants can lower the cost of an investigation.
    • Analysis of Stark's complexities, including how regulatory definitions can undermine arguments for both parties.
    • Exploration of the limitations in salary survey data and why it can be difficult to evaluate fair market value compensation.
    General Compliance
    #403
    403: A Sensible Approach to Global Security and Data Privacy Michelle Caswell, Principal, Coalfire Juan Carlos Palacio, Associate Privacy Counsel, Stryker
    • Learn from a global privacy attorney and a cybersecurity attorney/consultant on how an organization should approach leveraging enterprise-level reasonable and appropriate safeguards to satisfy a multitude of privacy regulations.
    • Understand the underlying similarities between various privacy regulations and security requirements and learn how to apply a reasonable and appropriate approach to information security to satisfy regulatory requirements
    • Minimize your team's level of effort in implementing appropriate security measures
    General Compliance
  • 03:45 PM - 04:00 PM
    Networking Break Snacks, Coffee, Hot Tea and Sodas available
  • 04:00 PM - 04:30 PM
    General Session 2: 2019 Update from CMS Kimberly Brandt, Principal Deputy Administrator for Operations, Centers for Medicare & Medicaid Services
    • Update on the agency’s ongoing burden reduction and regulatory reform efforts
    • Recent steps to advance interoperability and data sharing
    • CMS efforts to combat the opioid epidemic, including SUPPORT Act initiatives
    • Updates on CMS program integrity focus areas and regulatory changes

    • Tuesday, November 5

    • 07:15 AM - 08:15 AM
      Continental Breakfast
    • 08:15 AM - 08:30 AM
      Opening Remarks Tuesday
    • 08:30 AM - 09:30 AM
      General Session 3: OCR Update Roger Severino, Director, Office for Civil Rights
      • Describe recent HIPAA enforcement actions and recognize patterns of noncompliance
      • Identify best practices for HIPAA compliance
      • Explain the importance of risk analysis and other strategies for an effective HIPAA compliance program
    • 09:30 AM - 09:45 AM
      Networking Break Coffee & Hot Tea available
    • 09:45 AM - 10:45 AM
      Breakout Sessions