Healthcare Enforcement Compliance Conference
Virtual, Central Standard Time (CST)Agenda
Monday, November 7
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08:55 AM - 09:00 AMWelcome and Announcements
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09:00 AM - 10:30 AMBreakout Sessions#P01Recent Developments: Kickback and Stark Law Christopher Terranova, Senior Trial Counsel, U.S. DOJ Tony Maida, Partner, McDermott Will & Emery Niall O'Donnell , Assistant Chief , U.S. Department of Justice Criminal Division, Fraud Section
- Overview of Anti-Kickback or Stark Law developments and settlements
- Summary of recent regulatory developments including value-based payment arrangements
- Review and developments in all-payer kickback statue (EKRA 2018)
Intermediate#P02CIAs and IROs Steven Ortquist, Founder & Principal, Arete Compliance Solutions, LLC Darrell Contreras, Chief Compliance Officer, Millennium Health Nicole Caucci, Deputy Branch Chief, OIG HHS- Corporate integrity agreements and requirements for an Independent Review Organization (IRO)
- Obligations and role of an IRO
- Keys to successful IRO engagements
Intermediate -
10:30 AM - 10:45 AMBreak
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10:45 AM - 12:15 PMBreakout Sessions#P03Anatomy of a False Claims Act Case Paul Perkins, Deputy Director, U.S. DOJ Gabriel Imperato, Managing Partner, Nelson Mullins Riley & Scarborough Laura Laemmle-Weidenfeld, Partner, Jones Day
- 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
#P04Compliance Experts and Compliance Program Effectiveness Judy Ringholz, Founder and Principal, Sage Compliance Advisors, LLC Felicia Heimer, Senior Counsel, Office of Counsel To the Inspector General, U. S.- What to ask and look for in effectiveness evaluation proposals
- Things to consider as your effectiveness review is being conducted
- Using review results to improve your compliance program’s performance
Intermediate -
12:15 PM - 01:00 PMMid-Conference Break
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01:00 PM - 02:30 PMBreakout Sessions#P05Not Everything Is Illegal! Mitigating Risk by Clearly Distinguishing Between Regulatory Requirements and Guidance David Glaser, Shareholder, Fredrikson & Byron PA
- Suggestions for improving your hiring process for compliance professionals
- Tips for explaining complicated rules and legal hierarchy to compliance and medical professionals
- Strategies for analyzing contradictory "expert" opinions reducing legal anxiety
Intermediate#P06Enforcement Liability and Insolvency and Bankruptcy Laurence Freedman, Member, Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. Samuel Maizel, Director, Distressed Healthcare, Dentons US LLP- Tactical and practical considerations for entities and individuals under FCA investigation considering submitting financial disclosure documentation.
- Discussion of Department of Justice policies and procedures for considering "ability to pay" in False Claims Act cases.
- Discussion of FCA settlement process and documentation if entity or individual submitted financial disclosure documentation
Intermediate -
02:30 PM - 02:45 PMBreak
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02:45 PM - 04:15 PMBreakout Sessions#P07Federal/State Enforcement and the Opioid Crisis David Lazarus, Partner, Health Care and White Collar Defense, Verrill Dana LLP Kilby MacFadden, Principal Assistant Chief, U.S. Department of Justice Ashlee Martin, Partner, Gerger Hennessy & Martin Michael Clark, Senior Counsel , Womble Bond Dickinson
- Criminal and civil federal and state enforcement initiatives to combat the opioid crisis
- The legal basis for criminal and civil enforcement and the changing landscape
- Pain management and pain doctors and the opioid crisis
Intermediate#P08Hospital and Physician Compensation and Value-Based Arrangements Robert Wade, Partner, Nelson Mullins Riley & Scarborough LLP Edward White, Attorney, Nelson Mullins Law Firm- Emerging compensation arrangements including value-based/bundled Arrangements, quality, and access
- How are emerging contracting compensation arrangements complying with legal/regulatory requirements?
- How do emerging contracting compensation arrangements further integration for hospitals/physicians?
Basic
Tuesday, November 8
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08:55 AM - 09:00 AMOpening Remarks
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09:00 AM - 10:30 AMGeneral Session: Government Enforcement Panel Kirk Ogrosky, Partner, Goodwin Procter Jamie Yavelberg, Director, Fraud Section, Commercial Litigation Branch, Civil Division, USDOJ Toby Unger, Director , Massachusetts MFCU Gustav Eyler, Director, Consumer Protection Branch, U.S. Department of Justice Lisa Re, Assistant Inspector General for Legal Affairs, Office of Inspector General, Department of Health & Human Services Jacob Foster, Assistant Chief, U.S. Department of Justice
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10:30 AM - 10:45 AMBreak
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10:45 AM - 11:45 AMBreakout Sessions#101Effective Compliance and Due Diligence Kaitlyn Dunn, Counsel, Manatt Health Charles Overstreet, Sr Managing Director, FTI Consulting
- Explore the foundation of a comprehensive compliance-centered due diligence process
- Explore how transaction structures affect the scope and approach of due diligence, review the minimum compliance due diligence that should occur, and learn best practices for monitoring post-transaction compliance and mitigation of identified risks
- Examine case studies, lessons learned, practice tips, risks, and common pitfalls of conducting due diligence
Advanced#102Federal Administrative Sanctions Howard Young, Partner, Morgan Lewis Jacob Harper, Partner, Morgan Lewis & Bockius- Understand OIG enforcement actions, remedies, and appeals
- Appreciate differences between available CMS enrollment actions
- Identify new CMS program integrity rules and authorities
Basic#103Privacy Breach Response through the Eyes of a Business Associate Blaine Kerr, AVP, Deputy Chief Privacy Officer, Ensemble Health Partners Greg Kerr, Chief Privacy Officer, Ensemble Health Partners- Recognize the importance of establishing communication with the Covered Entity’s Privacy Office at or near the time the Business Associate Agreement is signed.
- Identify what obligations and tasks the Business Associate may have as part of the Privacy Breach Response.
- Learn the basics of providing comprehensive, accurate and timely reports to the Covered Entity.
Intermediate -
11:45 AM - 12:30 PMMid-Conference Break
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12:30 PM - 01:30 PMBreakout Sessions#201Effective Responses to Civil Investigative Demands Ilene Albala, Partner, Goodwin Procter LLP Lindsey Breedlove, Senior Counsel , Ultragenyx
- Learn the legal authority and the scope of civil investigative demands
- Learn the difference between a civil investigation demand and a subpoena
- Learn how to respond to civil investigative demands requesting e-data
Intermediate#202Enforcement and Compliance and Electronic Health Records Joseph Burby, Partner, Alston & Bird LLP Kelley Hauser, Senior Trial Counsel , U.S. DOJ- DOJ enforcement priorities related to electronic health records and recent enforcement actions
- Emerging compliance concerns and the impact of the 21st Century Cures Act
- Opportunities for collaborative efforts by EHR vendors, their counsel and the government related to compliance
Intermediate#203Enforcement, Compliance Officer, and General Counsel Laura Ellis, Senior Counsel, Office of Inspector General, HHS Shannon Sumner, Principal, PYA John Kelly, Partner & Chair of Healthcare Industry Practice, Barnes & Thornburg LLP- Learn about compliance and the role of general counsel management and the compliance officer
- OIG’s perspective on the general counsel and compliance officers
- Learn about management general counsel and compliance officers what works and what doesn’t work for effective compliance
Intermediate -
01:30 PM - 01:45 PMBreak
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01:45 PM - 02:45 PMBreakout Sessions#301Cybersecurity in Healthcare Privacy Cory Hall , Executive Director, Information Technology , Nicklaus Children's Health System Timothy Noonan, Deputy Director, Health Information Privacy Division, U.S. Department of Health and Human Services, Office for Civil Rights
- Assessing the current cybersecurity and privacy legal landscape and enforcement actions
- Emerging technologies: Cybersecurity and privacy risks for healthcare-related entities
- Addressing risks from supply chain and third-party vendors
Intermediate#302DOJ Criminal Enforcement, Priorities, and Practices Kirk Ogrosky, Partner, Goodwin Procter Kurt Erskine, Shareholder, Polsinelli- Learn about the Department of Justice’s criminal enforcement priorities in the Biden administration
- Review recent cases that reflect DOJ’s criminal enforcement policies and learn important takeaways from these enforcement actions
- A view of what we can expect from DOJ and other federal agencies in the area of criminal enforcement in the next couple of years
Advanced#303Whistleblowers, Who Are They, and What Makes a Good Whistleblower Case Jeb White, Presdient, Taxpayers Against Fraud Education Fund Shelley Slade, Partner, Vogel, Slade, & Goldstein, LLP Hamsa Mahendranathan, Partner, Constantine Cannon Josh Russ, Partner, Reese Marketos- Understand why employees become whistleblowers
- Advocate compliance culture that encourages internal reporting
- Recognize concerns that devolve into whistleblower cases
- List key factors of actionable whistleblower cases
Basic -
03:00 PM - 04:00 PMBreakout Sessions#401Criminal and Civil Enforcement and Telehealth Nadia de la Houssaye, Partner, Jones Walker LLP Raul Ordonez, Vice President & Chief Compliance Officer, Jackson Health System Justin Woodard , Greater New Orleans Region, Assistant Chief, U.S. Department of Justice, Criminal Division Brynn Schiess, Dallas, Texas, Acting Assistant Chief, U.S. Department of Justice, Criminal Division
- Telemedicine Fraud and Enforcement Efforts by DOJ and HHS-OIG ·
- COVID-19 Fraud Schemes - Examples and Warning Signs
- Genetic Testing, Urine Drug Testing and Other Lab Fraud Schemes
Intermediate#402Collateral Consequences to Audits and Adverse Enrollment Actions in a Post COVID-19 World Richard Burris, Shareholder, Polsinelli PC Andrew Wachler, Partner, Wachler & Associates, P.C.- Enrollment, claims audits, and False Claims Act liability
- Responding to adverse enrollment actions
- 60-day rules and investigations related to Covid-19 related services
#403Using Data in Enforcement and Compliance Martha Arvin, VP, Chief Compliance Officer, Erlanger Health System Laura Ellis, Senior Counsel, Office of Inspector General, HHS- How OIG uses data to fulfill its mission
- Why OIG recommends compliance officers have access to all the data
- How to find and use the data healthcare providers have
Intermediate -
04:00 PM - 04:15 PMBreak
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04:15 PM - 05:15 PMGeneral Session 2: OIG Investigate Efforts, Strike Force, Managed Care, and the Pandemic Christian Schrank, Deputy Inspector General for Investigations, DHHS OIG
- Participants should be able to understand OI’s role in Managed Care criminal, civil, and administrative proceedings.
- Participants should understand the necessary collaboration between OIG, DOJ, law enforcement partners, CMS contractors, as well as compliance offices and special investigative units to effectively protect the Medicare Trust Fund.
- Participants should understand the interaction and collaboration of OIG components associated with our pandemic response.
Wednesday, November 9
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08:55 AM - 09:00 AMOpening Remarks
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09:00 AM - 10:00 AMGeneral Session 3: Evaluating a Corporate Compliance Program Lauren Kootman, Trial Attorney - Compliance Specialist, U.S. Department of Justice, Criminal Division, Fraud Section
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10:15 AM - 11:15 AMBreakout Sessions#501Criminal and Civil Liability and Medical Necessity Holly Snow, Senior Trial Counsel, U.S. Department of Justice Judy Ringholz, Founder and Principal, Sage Compliance Advisors, LLC Jeffrey Dickstein, Partner, Phillips & Cohen LLP Rosalind Cordini, Senior Vice President, Coding & Compliance Services, Coker Group
- What medical necessity means and how it is established
- How medical necessity cases are enforced and the primary factors for distinguishing a civil medical necessity case from a criminal case
- Do robust compliance measures prevent medical necessity cases, and how to respond when a medical necessity matter arises within your organization
Intermediate#502Litigating a False Claims Act Case and Taking a False Claims Act Case to Trial Tom Morris, Senior Trial Counsel, U.S. DOJ Michael Bittman, Partner, Nelson Mullins Broad and Cassel Bradley Klein , Partner, Skadden- Define and discuss key provisions of the False Claims Act that regularly get litigated
- Identify emerging issues that often arise during FCA litigation
- Learn strategies for maximizing discovery in FCA cases
Basic#503The Medicare Secondary Payer Act - Best Practices and Emerging Issues William McClintock, Senior Associate , King & Spalding, LLP Yelena Kotlarsky, Senior Associate, Special Matters & Government Investigations, King & Spalding, LLP- Understand the reporting and repayment obligations under the MSP statute
- Learn best practices to mitigate CMS penalties and other exposure
- Understand emerging issues facing your workforce given the changing regulatory landscape
Basic -
11:15 AM - 12:00 PMMid-Conference Break
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12:00 PM - 01:00 PMBreakout Sessions#601Beneficiary Inducement and False Claims Act Karen Glassman, Senior Counsel, Office of Counsel to the IG, DHHS Ilene Albala, Partner, Goodwin Procter LLP
- Prohibitions against beneficiary inducement for healthcare services
- False claims and civil money penalty liability
- OIG fraud alerts and authorities on prohibited beneficiary inducement
- Criminal and civil liability for routine waiver of co-payments
Intermediate#602Managed Care Enforcement and Compliance Daniel Meron, Partner, Latham & Watkins LLP Niurka Adorno-Davies, AVP Compliance, Molina Healthcare of South Carolina & Molina Healthcare of Puerto Rico- Managed care fraud and enforcement actions
- Managing compliance risks in managed care
- Education and training and managed care compliance
Intermediate#603False Claims Act Liability and Post-Acute Care Janet Feldkamp, Partner, Benesch, Friedlander, Coplan & Aronoff Lisa Renaker, Chief Compliance Officer, Communicare Family of Companies- A review of recent False Claims Act cases, both civil and criminal, and current enforcement focus areas in Medicare for SNF, home health, and hospice providers
- Challenges facing post-acute providers, including those associated with new payments systems and regulatory requirements, and new claim audit initiatives
- Current enforcement trends, including potential liability for providers and management, sources of data to manage risk, expectations from CMS, and enhanced focus on “worthless care” concerns
Intermediate -
01:00 PM - 01:15 PMBreak
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01:15 PM - 02:15 PMBreakout Sessions#701Handling a Criminal Healthcare Fraud Case Ralph Caccia, Partner, Wiley Rein LLP Fritz Scanlon, D.C. Assistant Chief, U.S. Department of Justice, Criminal Division
- The role of data in criminal cases
- Emerging criminal enforcement trends
- Responding to criminal investigations and prosecutions
Intermediate#702Negotiating and Mediating False Claims Act Cases Sarah Arni, Senior Trial Counsel Janice Symchych, Mediator and Arbitrator, JAMS Sean O'Connell, Counsel, Hunton Andrews Kurth LLP- False Claims Act settlements and DOJ policy and procedure
- Negotiating and mediating False Claims Act cases
- Drafting False Claims Act settlement agreements
Intermediate#703Enforcement and Compliance Clinical Research F. Lisa Murtha, Partner, Moses & Singer LLP Clint Narver, Assistant Director, Consumer Protection Branch, U.S. Department of Justice- This session will explain new research related laws and regulations as well as potential fraud focus areas affecting research across the United States
- The speakers will outline the circumstances surrounding recent OIG/DOJ investigations and settlements over the last 24 months
- The speakers will make practical recommendations for compliance oversight of research programs in an effort to avoid investigations and maintain ongoing compliance
Intermediate -
02:15 PM - 02:30 PMBreak
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02:30 PM - 03:30 PMBreakout Sessions#801Medicaid Fraud Enforcement Jack Wenik, Partner, Epstein Becker & Green PC Andrew Schulke, Chief Deputy Attorney General , Medicaid Fraud Control Unit - Nevada
- Medicaid fraud control unit collaboration and coordination
- Medicaid fraud identification, investigation, and multi-state prosecution
- Government and defense perspectives on Medicaid fraud investigations
Intermediate#802Behavioral Health Jim Hayes, Senior Litigation Counsel, U.S. Department of Justice, Criminal Division- Eliminating kickbacks in recovery act and its application to behavioral health
- Federal and state enforcement against mental health and substance abuse treatment facilities and sober homes
- Common arrangements and kickback liability
Basic#803Internal Investigation, Repayment and Self-Disclosure Brian Bewley, Partner - Healthcare & Life Sciences, Manatt, Phelps & Phillips, LLP Tamar Terzian, Senior Counsel, Office of Inspector General, HHS- Authority and practical considerations for conducting internal investigations
- Procedures and best practices for internal investigations
- Evaluation and report and potential self-disclosure
Intermediate
Session Levels
All sessions have a knowledge level associated with them, these levels are just guidelines and you are free to attend sessions of any level.
Basic: Program knowledge level most beneficial to Compliance Professionals new to a skill or an attribute. These individuals are often at the staff or entry level in organizations, although such programs may also benefit a seasoned professional with limited exposure to the area.
Intermediate: Program knowledge level that builds on a basic program, most appropriate for Compliance Professionals with detailed knowledge in an area. Such persons are often at a mid-level within the organization, with operational or supervisory responsibilities, or both.
Advanced: This level focuses on the development of in-depth knowledge, a variety of skills, or a broader range of applications. Advanced level programs are often appropriate for seasoned professionals within organizations, and professionals with specialized knowledge in a subject area.