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 Madeline Bainer, Senior Counsel, HHS-OIG Colin Huntley, Assistant Director, Commercial Litigation Branch, Fraud Section, Civil Division, U.S. DOJ
    • 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, VP of Compliance, Samaritan Health System Christina Villa, Senior Compliance Analyst, Adventist Health Ana-Cristina Navarro, Deputy Chief Compliance Officer, HealthRIGHT360
    • 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
    100
  • 10:30 AM - 10:45 AM
    Networking Break Coffee & Hot Tea available
    Networking
  • 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 Lafferty, Of Counsel, Gunster, Yoakley & Stewart, PA 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 Sally Molloy, Chief, Strategy, Policy and Training Unit, U.S. Department of Justice, Criminal Division, Fraud Section Jillian Sparks, Senior Counsel, Industry Guidance Branch, U.S. Department of Health and Human Services, Office of Counsel to the Inspector General

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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)
    Networking
  • 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 LLP 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, Partner, Barnes & Thornburg LLP Lisa Adkins, SVP/Chief Compliance and Privacy Officer, University of Maryland Shannon Sumner, Principal, 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
    Networking
  • 03:15 PM - 04:45 PM
    Breakout Sessions
    #P10
    P10: Cyber Security and Health Care Privacy Roy Wyman, Attorney, Nelson Mullins Riley & Scarborough LLP David Kessler, Public Sector Product Compliance Counsel, Verizon Martha Arvin, VP, Chief Compliance Officer, Erlanger Health System Joseph Dickinson, Member, Nexsen Pruet, PLLC
    • 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, Partner - Healthcare & Life Sciences, Manatt, Phelps & Phillips, LLP Heather Bokor, VP / Chief Compliance, Privacy & Risk Officer, Health Care District of Palm Beach County Nicole Caucci, Deputy Branch Chief, OIG HHS David Fuchs, Senior Counsel, Office of Counsel to the IG, U.S. Department of Health and Human Services
    • 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.
    Networking

    • Monday, November 4

    • 07:00 AM - 08:00 AM
      Continental Breakfast
      Networking
    • 08:00 AM - 08:15 AM
      Opening Remarks Monday
      General Compliance
    • 08:15 AM - 09:30 AM
      General Session: Government 1: Enforcement Panel Kirk Ogrosky, Partner, Goodwin Procter 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, Chief of the Department of Justice, Health Care Fraud Unit, Criminal Division, U.S. Department of Justice
      • Discussion of DOJ Criminal and Civil Enforcement Priorities
      • Discussion of OIG and CMS Enforcement Initiatives
      • Discussion of Medicaid Fraud Enforcement Priorities
      General Session
    • 09:30 AM - 10:00 AM
      Networking Break Coffee & Hot Tea available
      Networking
    • 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, VP / Chief Compliance, Privacy & Risk Officer, Health Care District of Palm Beach County 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, Nelson Mullins 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
      Networking
    • 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 Officer, Trinity Health
      • 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, Compliance/Privacy Manager, UCHealth Michael Sandulak 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, AVP, Deputy Chief Privacy Officer, Ensemble Health Partners 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
    Networking
  • 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 Lafferty, Of Counsel, Gunster, Yoakley & Stewart, PA
    • 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, Grubman, Dalbey & Warner, LLP
    • 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
    Networking
  • 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
    Networking
  • 04:00 PM - 04:30 PM
    General Session 2: 2019 Update from CMS Kimberly Brandt, Partner, Tarplin, Downs & Young
    • 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
    General Session

    • Tuesday, November 5

    • 07:15 AM - 08:15 AM
      Continental Breakfast
      Networking
    • 08:15 AM - 08:30 AM
      Opening Remarks Tuesday
      General Compliance
    • 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
      General Session
    • 09:30 AM - 09:45 AM
      Networking Break Coffee & Hot Tea available
      Networking
    • 09:45 AM - 10:45 AM
      Breakout Sessions
      #501
      501: Delegate Oversight and Protecting PHI Erin Miskell, Consultant, ATTAC Consulting Group LLC
      • General delegation oversight requirements and how the plan holds ultimate responsibility
      • The risk of a HIPAA breach not only within the health plan operations but also through delegate systems, processes and activities
      • Prevention mechanisms plans should employ, including education to delegates and plan representatives who manage delegate relationships, attestations, and contractual provisions. Detection mechanisms including auditing, monitoring
      General Compliance
      #502
      502: Root Cause Analysis Workshop Rosalind Cordini, Senior Vice President, Coding & Compliance Services, Coker Group Dwight Claustre, Retired Compliance Professional
      • Participants will review and understand the Department of Justice’s 2017 guidance pertaining to the performance of root cause analyses.
      • Participants will understand the root cause analysis structure and purpose.
      • Participants will perform a root cause analysis pertaining to a [mock] serious compliance issue to learn skills for the performance of a root cause analysis in their institutions/organizations
      General Compliance
      #503
      503: Confidentiality of Substance Use Disorder Records Karolina Austin, HIM Director/ Privacy Officer, Operation PAR
      • To obtain a strong knowledge of the confidentiality and privacy regulations that govern substance abuse facilities and records
      • Understand new changes and consent requirements of the final rule established in 2017
      • Understand the restrictions and how to explain them to requesters, gain ability to educate other entities and agencies about the privacy regulations of 42 CFR part 2
      General Compliance
    • 10:45 AM - 11:15 AM
      Networking Break: Last Chance to Visit the Exhibit Hall Coffee and Hot Tea available
      Networking
    • 11:15 AM - 12:15 PM
      Breakout Sessions
      #601
      601: Controlled Substance Crisis: A Holistic Approach for Hospitals Tamara Mattox, Consultant, Crowe Healthcare
      • Leading practices from a large healthcare system on their holistic approach to controlled substance diversion and abuse monitoring
      • Share the key critical fundamentals that every hospital should have
      • Share the vision of the future state of hospital controlled substance monitoring through automation through the latest technologies such as blockchain and artificial intelligence
      General Compliance
      #602
      602: Compliance and Risk Assessments: Prepared? Uday Ali Pabrai, CEO, ecfirst Marcie Swenson, President, Skyda Law Group
      • Prepare for 2020 privacy & security mandates including lessons learned from recent settlements and enforcement.
      • Examine core components necessary to conduct a comprehensive and thorough privacy & security risk assessment.
      • Walk through key areas for designing & establishing a credible, evidence-based privacy & security risk assessment program.
      General Compliance
      #603
      603: Quality Payment Program Raul Ordonez, Assoc VP for Compliance, Jackson Health System Michael Stearns, Chief Executive Officer, Apollo HIT, LLC
      • CMS Quality Payment Program (QPP): Identify aspects of the program that have the potential for fraud, waste and abuse and their prospect for enforcement
      • Risk adjustment in the QPP - Will we see compliance challenges similar to Medicare Advantage?
      • Clinical documentation integrity challenges in the QPP
      General Compliance
    • 12:15 PM - 01:15 PM
      Networking Lunch
      Networking
    • 01:15 PM - 02:15 PM
      Breakout Sessions
      #701
      701: Ask the Stark Law Professionals Charles Oppenheim, Partner, Hooper Lundy Bookman, PC Lester Perling, Senior Counsel, McDermott Will & Emery LLP Robert Wade, Partner, Nelson Mullins Riley & Scarborough LLP
      • General overview of the Stark Law
      • Bring your Stark Law questions and the panel will analyze and discuss "real time" potential Stark Law risks
      • "Live"answers to your Stark Law operational questions
      General Compliance
      #702
      702: The Opioid Crisis and Compliance Amy Boring, Attorney, King & Spalding LLP Michelle Seegers, Regulatory Risk Manager, Comcast Julia Russell, Associate Director, Protiviti
      • Compliance Requirements and Beyond - Evaluating the effectiveness of your compliance program and remedial efforts to implement or improve one in the face of the opioid epidemic
      • Systems Controls - Addressing which buttons and levers can be pulled and protected to achieve 100% compliance for each team of stakeholders while retaining individual decision-making authority of the clinicians
      • Response Plan - Implementing a response plan in a multidisciplinary project plan to address vulnerabilities and improve the coordinate response of the Compliance Program
      General Compliance
      #703
      703: Navigating Parallel Investigations, Criminal, Civil, State and Federal Sally Blinken, Counsel, Lupkin PLLC Edward Baker, Counsel, Constantine Cannon LLP
      • Government investigations of alleged healthcare fraud are often far more complex and multi-faceted than they may first appear, particularly to the entities or persons under investigation.
      • Parallel investigations-whether state/federal or civil/criminal/administrative-present significant challenges and pitfalls for all parties.
      • A global resolution of all aspects of an investigation is generally in the best interest of all parties, but often difficult to achieve.
      General Compliance
    • 02:15 PM - 02:30 PM
      Networking Break
      Networking
    • 02:30 PM - 03:30 PM
      Breakout Sessions
      #801
      801: Patient Support Services and False Claims Act Risks Winston Chan, Partner, Gibson, Dunn & Crutcher LLP William Harrington, Partner, Goodwin Procter LLP A. Marisa Chun, Partner, Crowell & Moring LLP
      • Healthcare providers face increasing scrutiny for patient support services programs. These services range from reimbursement assistance to wellness counseling.
      • In some instances, the government's focus has turned to services provided to healthcare providers. In all cases, the investigatory focus is whether these services constitute unlawful inducements.
      • This panel of former prosecutors will provide an overview of the government's recent enforcement actions in this area, and engage in an interactive discussion concerning risk factors and mitigation strategies.
      General Compliance
      #802
      802: Enforcement and Compliance, Retail Pharmacy Selina Coleman, Partner, Reed Smith LLP Daniel Fitzgerald, Senior Counsel, Government Litigation Dept., Walgreen Co.
      • Compliance strategies related to scrutiny of pharmacy rewards, government audit initiatives, and other hot topics in pharmacy law
      • Discount card programs in the wake of lawsuits alleging that club prices are the "usual & customary" charges that should have been passed on to payers
      • Practical implications of post-Escobar cases on potential allegations of False Claims Act violations in the retail pharmacy environment
      General Compliance
      #803
      803: Clinical Trial Enforcement and Compliance F. Lisa Murtha, Partner, Moses & Singer LLP Toby Boenig, Vice President and Chief Compliance Officer, UTMB Health
      • This session will outline recent enforcement efforts/cases from the OIG, the FDA, OHRP, the DOJ, and ORI
      • Based upon recent enforcement cases, the session will detail common high risk areas for research organizations
      • This session will then summarize efforts that research compliance professionals should take to address all of the high risk areas.
      General Compliance
    • 03:30 PM - 03:45 PM
      Networking Break
      Networking
    • 03:45 PM - 04:45 PM
      General Session 4: Operationalizing Compliance Through Data Analytics James Passey, Vice President, Chief Audit & Compliance Officer, HonorHealth Vince Walden, CEO, Kona AI Lee Tiedrich, Distinguished Faculty Fellow in Ethical Technology and Law Professor, Duke University Geoffrey Hymans, Deputy Branch Chief, Exclusions Branch , OIG
      • Understand leading frameworks for operationalizing compliance
      • Leading analytical techniques and practical case examples
      • Analytics considerations and pitfalls to avoid when deploying your program
      General Session

    Wednesday, November 6

    • 08:30 AM - 10:00 AM
      Breakout Sessions
      #POST
      Post Conference
      #W1
      W1: SNF Mandatory Compliance is Here: Lessons Learned from CIAs Tamar Abell, CEO, TBA Consultant Claudia Reingruber, Shareholder, Saltmarsh, Cleaveland & Gund
      • Review of the RoP for Skilled Nursing Home mandatory compliance program and how it will effect long-term care facilities
      • Lessons learned from corporate integrity agreements and challenges long-term care organizations face in operationalizing including anti-kickback violations and working with IROs and Federal Quality of Care Monitors
      • Tools for implementation and risk assessment specific for post-acute providers
      General Compliance
      #W2
      W2: The Parkland Health & Hospital System Story: How We Learned, the Hard Way, What Every Healthcare Organization Must Know Mary Findley, Sr. Director, Alvarez & Marsal Healthcare Industry Group Robert D. Martinez, Retired Board Member, Parkland Health Kathleen Murphy, Managing Director, Alvarez & Marsal Felicia Heimer, Senior Counsel, Office of Counsel To the Inspector General, U. S.
      • Implementing a Systems Improvement Agreement with CMS and a Corporate Integrity Agreement with OIG and monitoring Parkland's transformation: Important perspectives from the Chief Compliance Officer, Board Member, Review Organization and Regulator.
      • Parkland's governance and cultural overhaul - meaningful board oversight, tone at the top, disclosure/non-retaliation, effective communication, buy-in at all levels.
      • Using the experiences from Parkland's SIA and CIA to stand up sustainable and effective compliance and quality programs.
      General Compliance
      #W3
      W3: Enforcement and the Opioid Crisis Gary Cantrell, Deputy Inspector General for Investigations, OIG HHS Jill Furman, Deputy Director, Consumer Protection Branch, U.S. D.O.J. Katherine Payerle, Assistant Chief, Healthcare Fraud Unit, U.S. Department of Justice
      • Latest trends and enforcement strategies in the fight against prescription opioid diversion and fraud
      • Use of data to detect and investigate fraud and diversion and to measure impact
      • Collaboration and data sharing, public and private sector partnerships
      • Fraud and access concerns in the treatment of substance use disorder
      General Compliance
    • 10:00 AM - 10:15 AM
      Networking Break Coffe & Hot Tea available
      Networking
    • 10:15 AM - 11:45 AM
      Breakout Sessions
      #W4
      W4: Privilege and Compliance Nicholas Merkin, CEO, Compliagent Anna Grizzle, Partner, Bass, Berry & Sims PLC
      • Compliance programs may produce evidence of regulatory violations against healthcare organizations and their officers/directors. CCOs, however, are required to communicate that data to internal/external stakeholders as part of robust compliance efforts
      • In some cases, evidentiary privileges may protect this information from disclosure and, thus, encourage more robust auditing and monitoring activities, thorough internal investigations, and transparent communications concerning compliance matters
      • The scope and use of these privileges in the context of compliance programs, however, is often misunderstood. This presentation will explore and clarify the application of different privileges and provide practical advice as to appropriate usage
      General Compliance
      #W5
      W5: 21st Century Data and Detection: Implementing a World-Class Global Continuous Monitoring Program to Detect FCPA and Kickback Risks Before They Become Systemic Parth Chanda, CEO, Lextegrity Jeffrey Klink, President and CEO, KLINK
      • Learn hands-on best practices from former in-house and outside counsel and a cutting-edge technologist about how healthcare companies can manage their data to reduce their risks.
      • Understand how to get the structured and unstructured data you need, what analytical risk tests to run on that data, and how to action risk flags and use machine learning to improve your risk analyses over time
      • Most importantly, learn how companies can operationalize and embed continuous monitoring into existing company processes in a sustainable and cost-effective way without needing an army of new compliance headcount
      General Compliance
      #W6
      W6: Medical Necessity and the False Claims Act JD Thomas, Partner, Waller Lansden Dortch & Davis, LLP Jeffrey Dickstein, Partner, Phillips & Cohen LLP Robert McAuliffe, Assistant Director, United States Department of Justice, Civil Division
      • Medical necessity cases are very much alive in the FCA world, though the environment is ever-changing. This panel of attorneys, with experience in the government, defense, and relator’s bar will examine the evolving landscape
      • We will consider legal issues around medical necessity cases, recent rulings, 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
      General Compliance
    • 11:45 AM - 12:30 PM
      Lunch (On Your Own)
      Networking
    • 12:30 PM - 01:00 PM
      CHC Exam Check In
      Exam
    • 01:00 PM - 03:30 PM
      CHC Exam
      Exam

    Agenda subject to change.

    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.