November 15 - 18, 2020
2020 Healthcare Enforcement Compliance Conference
Washington, DC, United StatesAgenda
Sunday, November 15
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09:00 AM - 10:30 AMBreakout Sessions#P01P1: Anatomy of a False Claims Act Katherine Lauer, Partner, Latham & Watkins, LLP Michael Morse, Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP Sean O'Connell, Counsel, Hunton Andrews Kurth LLPGeneral Compliance#P02P2: Encryption: Policy to Practice, Lower Risk, Increase Compliance! Uday Ali Pabrai, CEO, ecfirst
- Examine encryption mandates defined in HIPAA Security, HITECH Act, PCI DSS, State regulations and more
- Review specific areas that encryption can have a significant impact in lowering enterprise risk, while improving compliance posture
- Step through core elements of an encryption policy to address both at rest and in motion requirements and understand how to simplify the use of encryption in your organization and do so consistently
General Compliance#P03P3: Medicaid Fraud Enforcement Update Josh Lichtblau, Director, Medicaid Fraud Division, NJ Comptroller's Office Jack Wenik, Partner, Epstein Becker & Green PC- Recent developments in Medicaid fraud/abuse enforcement at the state level, including regarding managed care organizations.
- Focus on home health, adult day care and other providers receiving extra scrutiny.
- Government and defense perspectives in responding to Medicaid fraud and abuse investigations.
General Compliance -
09:00 AM - 12:30 PMPre Conference AM Pre Conference
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10:30 AM - 11:00 AMNetworking Break
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11:00 AM - 12:30 PMBreakout Sessions#P04P4: Litigating a False Claims Act Case John Boese, Of Counsel, Fried, Frank, Harris, Shriver & Jacobson LLP Scott Grubman, Partner, Chilivis, Grubman, Dalbey & Warner, LLP Amy Easton, Partner, Phillips and Cohen LLPGeneral Compliance#P05P5: Is your Conflicts of Interest Program Effective? Debra Berns, Senior Vice President and Chief Risk Officer, as Memorial Sloan Kettering Cancer Center Julie Hamilton, Managing Director, Deloitte & Touche LLP Colleen Curran, Managing Director, Alvarez & Marsal Healthcare Industry Group
- Highlights of regulatory and enforcement activity related to Conflicts of Interest COI
- Components of an effective COI program
- Lessons learned and tactical steps for assessment and enhancement of COI programs
General Compliance#P06P6: Understanding the Components of a Comprehensive Compliance Risk Assessment Process Carrie Kusserow, Managing Senior Consultant, Strategic Management Services Anne Daly, Chief Compliance & Integrity Officer, Children's Hospital of Chicago Medical Center- Review the importance of risk assessment in health care compliance, including an overview of historical and recently published health care regulator guidance and enforcement (DOJ, OIG, OCR etc.)
- Outline and discuss the core components for a credible compliance risk assessment process
- Elaborate on processes, tips and best practices for implementing and supporting compliance risk identification and mitigation
General Compliance -
12:30 PM - 01:45 PMLunch (On Your Own)
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01:45 PM - 03:15 PMBreakout Sessions#P07P7: Handling a Criminal Healthcare Fraud CaseGeneral Compliance#P08P8: Root Cause Analysis Workshop Dwight Claustre, Retired Compliance Professional Rosalind Cordini, Senior Vice President, Coding & Compliance Services, Coker GroupGeneral Compliance#P09P9: DOJ Updated Guidance – June 2020 Judy Ringholz, VP of Compliance and Ethics & Chief Compliance Officer, Jackson Health SystemGeneral Compliance
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01:45 PM - 05:15 PMPre Conference PM
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03:15 PM - 03:45 PMNetworking Break
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03:45 PM - 05:15 PMBreakout Sessions#P10P10: Federal Administrative Sanctions Julie Kass, Lawyer, Baker DonelsonGeneral Compliance#P11P11: Big Data: How Can it be Shared and What are the Considerations Regarding Enforcement? Marti Arvin, Executive Advisor, CynergisTek, Inc. Blaine Kerr, Chief Privacy Officer, Jackson Health System
- Brief primer on the way in which individually identifiable information can be shared with regulatory parameters, both federal and state
- Discussion of considerations when evaluating the sharing of big data sets with 3rd parties for healthcare operations and/or research
- Overview of the enforcement trends: Where it has been, where it is going, consumer privacy concerns, class actions and more
General Compliance#P12P12: Why Whistleblowers Matter to Healthcare Compliance Tony Maida, Partner, McDermott Will & Emery- In light of recent research suggesting that companies with robust internal reporting systems are more profitable, and have lower litigation costs, than those that do not, what is the best way to handle whistleblower complaints to minimize risk
- What is the process by which whistleblower complaints are filed, investigated, and litigated by the government
- Strategies and best practice techniques to evaluate, litigate, and settle FCA qui tam complaints
General Compliance -
05:15 PM - 06:45 PMWelcome Reception Join us for a networking reception with our Exhibitors.
Monday, November 16
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07:00 AM - 08:00 AMContinental Breakfast
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08:00 AM - 08:15 AMOpening Remarks Monday
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08:15 AM - 09:30 AMGS1: Government Compliance Enforcement Panel
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09:30 AM - 10:00 AMNetworking Break
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10:00 AM - 11:00 AMBreakout Sessions#101101: Preventing Enforcement Actions in Clinical Research - Operational Strategies for Avoiding Financial Frauds Brian Annulis, Sr Managing Director, Ankura Consulting Group
- Billing errors in Clinical Research can and have resulted in large settlements arising from False Claims Act violations
- Accurate billing for research activities is dependent on an multi-step process involving numerous players, departments, and functions. Breakdowns at any point in the process can result in large fines, settlements, and CIAs
- This presentation will show how successful clinical research billing (CRB) revolves around ensuring your clinical research operations team is effectively communicating and that the rules are properly interpreted and applied
General Compliance#102102: The Secret Sauce for Complying with Privacy Regulations Karen Snyder, Dir Healthcare & Life Sciences Channels Solutoins, Iron Mountain Darrell Contreras, Chief Compliance Officer, Millennium Health- Privacy is more of a priority than ever. Organizations must be able to react and respond quickly to increasing consumer privacy concerns, data breaches, and heavy-hitting regulations such as the CCPA and GDPR
- The key to a successful privacy program is instituting an information lifecycle management (ILM) program that provides strong governance rooted in policy. This protects your organization from compliance risks and is vital to protecting patient privacy
- Join us to discuss the impact of today's privacy regulations and learn how ILM enables you to secure a unified view of patient data and related obligations, dispose of PHI in accordance with retention requirements, and reduce exposure to data breaches
General Compliance#103103: The Myth(s) of Median to 75th: New Perspectives on Assessing, Managing and Monitoring Physician Compensation Arrangement Risk Adam Klein, Principal, ECG Management Consultants James Sheehan, Chief, Charities Bureau, NY Attorney General Heather Fields, Shareholder, Chair - Hospital/Health Systems Practice, Reinhart Boerner Van Deuren s.c.- Impact of USA ex rel. Bookwalter v. UPMC 938 F.3d 397 (3d Cir. December 20,2019)-the new Stark burden of proof is on the hospital
- Lessons from litigated cases about improving your organization's physician compensation arrangement risk assessment process and strategies and resources for identifying and managing outlier arrangements at an enterprise level
- Innovative, lower cost, and more effective risk management approaches alternatives for determining and monitoring FMV and commercial reasonableness, including tips for mitigating risks inherent in relying on survey data and "independent" FMV reviews
General Compliance -
11:00 AM - 11:30 AMNetworking Break
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11:30 AM - 12:30 PMBreakout Sessions#201201: Managed Care Enforcement and Compliance Pamela Brecht, Attorney/Partner, Pietragallo Gordon Alfano Bosick & Raspanti, LLP Barbara Fonte, Vice President of Managed Care and Population HealthGeneral Compliance#202202: How OIG Uses Data in its Affirmative Cases & How Data Can be Incorporated into Compliance Geoffrey Hymans, Senior Counsel, Office of Inspector General, US Health and Human Services
- Learn how the OIG uses data to develop affirmative Civil Monetary Penalty Law and Exclusion cases
- Learn how data can be used in unorthodox ways, such as to prove knowledge, or in quality-of-care cases
- Learn how both large and small entities can incorporate data analysis into their compliance programs
General Compliance#203203: HHS’ Regulatory Sprint to Coordinate Care-
To the extent HHS publishes any Regulatory Sprint final rules before the conference, OIG and CMS representatives will discuss the Regulatory Sprint to Coordinated Care and the provisions of any final rule, including
- The legal and policy drivers of the Regulatory Sprint to Coordinated Care
- Overview of the provisions of any final rules
General Compliance -
12:30 PM - 01:30 PMNetworking Lunch
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01:30 PM - 02:30 PMBreakout Sessions#301301: False Claims Act Liability in Post-Acute Care Claudia Reingruber, Shareholder, Saltmarsh, Cleaveland & Gund
- 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 that providers have effective compliance programs, and enhanced focus on "worthless care" concerns
General Compliance#302302:Staying Afloat in a Sea of Privacy Laws Jeff Gibson, Member, Bass, Berry & Sims John Bailey, Global Privacy Counsel, St Jude Children's Research Hosp- Review domestic and international data privacy laws and trends
- Identity practical steps to understand laws applicable to your organization
- Identify resources to help your organization comply with competing and potentially conflicting laws
General Compliance#303303: Lessons Learned from Stark Investigations David Glaser, Shareholder, Fredrikson & Byron PA Matthew Krueger, United States Attorney, Eastern District of Wisconsin- A U.S. 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 -
02:30 PM - 03:00 PMNetworking Break
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03:00 PM - 04:00 PMBreakout Sessions#401401: Enforcement and Compliance for Pharmacies Josh Lichtblau, Director, Medicaid Fraud Division, NJ Comptroller's Office Jennifer Krusa, Chief Compliance Officer Daniel Meier, Healthcare Regulatory and Transactional Attorney, Benesch Friedlander Coplan & Aronoff
- Medicaid Enforcement Behind-the-Scenes: Identifying a healthcare provider / supplier with a focus on comparing claims, data mining and oddities
- Pharmacy's Response: How to prepare for a state Medicaid review / audit, seek guidance and address the issues
- Resolution: Counsel's role in considering options such as paybacks to MACs, use of the self-disclosure protocol or proceeding to litigation after appeals are exhausted, including discussion about cases and documentation
General Compliance#402402: Compliance Repayment and Self-Disclosure Edward Baker, Counsel, Constantine Cannon LLP Sandra Miller, Attorney, Womble Bond Dickinson (US) LLPGeneral Compliance#403403: Trends and Best Practices in Healthcare Privacy and Security Investigations Timothy Noonan, Deputy Director, Health Information Privacy Division, U.S. Department of Health and Human Services Office for Civil Rights Jonathan Skrmetti , Chief Deputy Attorney General, Office of Tennessee Attorney General Brian Stimson, Principal Deputy General Counsel, U.S. Department of Health and Human Services- Trends in management and reporting of health information privacy and security incidents
- Emerging federal and state enforcement priorities regarding health information privacy and security
- Best practices for regulated entities involved in health information privacy or security investigations
General Compliance -
04:00 PM - 04:30 PMNetworking Break
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04:30 PM - 05:30 PMGS2: Civil and Criminal Enforcement Under the New Stark & Anti-Kickback Statute Rules Neil Evans, Attorney, Lane Powell PC
Tuesday, November 17
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07:15 AM - 08:15 AMContinental Breakfast
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08:15 AM - 08:30 AMOpening Remarks Tuesday