Sunday, November 3
09:00 AM - 10:30 AMBreakout Session 1#P01P1: Anatomy of a False Claims Act Case Katherine Lauer, Partner, Latham & Watkins, LLPGeneral Compliance#P02P2: CIA Focus Arrangements, Claims Review & IRO's Steven Ortquist, President, Arete Compliance Solutions, LLC Glennon Moyers, Partner, KPMG LLP
General Compliance#P03P3: Navigating Enforcement Action, Investigations, and Settlements Anne Daly, Chief Compliance and 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
- What is new/what has changed in the new Focus Arrangement CIA form?
- Critical elements of an arrangements compliance program
- Understanding Focus Arrangements risks: What settlements and recent enforcement actions tell us
- 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
09:00 AM - 12:15 PMPre Conference AM Pre Conference
10:30 AM - 10:45 AMNetworking Break Coffee & Hot Tea available
10:45 AM - 12:15 PMBreakout Session 2#P04P4: Litigating a False Claims Act Case John Boese, Of Counsel, Fried, Frank, Harris, Shriver & Jacobson LLP Robert Vogel, Partner, Vogel, Slade & Goldstein, LLP LT Lafferty, Partner, Holland & KnightGeneral Compliance#P05P5: Anti-Kickback Developments Tony Maida, Partner, McDermott Will & Emery
General Compliance#P06P6: Managed Care Enforcement and Compliance Kay Mesia, CEO/Chief Compliance Officer, Two International Rose Dunn, Chief Operating Officer, First Class Solutions, Inc. Benjamin Singer, Partner, O’Melveny & Myers LLPGeneral Compliance
- In-depth analysis of the new all-payor kickback statute, Eliminating Kickbacks in Recovery Act of 2018 (EKRA)
- Comparing EKRA to the federal health care program anti-kickback statute
- Tips for compliance strategies and risk assessment
12:15 PM - 01:30 PMLunch (On Your Own)
01:30 PM - 03:00 PMBreakout Session 3#P07P7: Negotiating False Claims Act Settlements and Mediation Jack Wenik, Partner, Epstein Becker & Green PC Janice Symchych, Case Manager, JAMS Sean O'Connell, Assistant United States Attorney, U.S. Department of Justice Laura Laemmle-Weidenfeld, Partner, Jones Day
General Compliance#P08P8: Handling a Criminal Healthcare Fraud Case Richard Westling, Member, Epstein Becker & Green, P.C. Ralph Caccia, Partner, Wiley Rein LLPGeneral Compliance#P09P9: 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
- 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
- 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
01:30 PM - 04:45 PMPre Conference PM
03:00 PM - 03:15 PMNetworking Break Coffee & Hot Tea available
03:15 PM - 04:45 PMBreakout Session 4#P10P10: 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.General Compliance#P11P11: Federal Administrative Sanctions: Exclusions, Civil Money Penalties, and Case UpdateGeneral Compliance#P12P12: Compliance, Repayment and Self-Disclosure Brian Bewley, Member, Bass Berry & Sims PLC Heather Noughton-Bokor, Sr Dir Corporate Compliance, University of Florida Health SystemGeneral Compliance
04:45 PM - 06:15 PMWelcome 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 AMContinental Breakfast
08:00 AM - 08:15 AMOpening Remarks Monday
08:15 AM - 09:30 AMCompliance Keynote Address
09:30 AM - 10:00 AMNetworking Break Coffee & Hot Tea available
10:00 AM - 11:00 AMBreakout Session 1#101101: Collateral Consequences to Audits and Adverse Enrollment Actions Richard Burris, Shareholder, Polsinelli PC Andrew Wachler, Partner, Wachler & Associates, P.C.
General Compliance#102102: What Makes a Compliance Program "Effective"?" Thomas Beimers, Partner, Hogan Lovells Heather Noughton-Bokor, Sr Dir Corporate Compliance, University of Florida Health System
- 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#103103: Due Diligence and Compliance Edgar Bueno, Partner, Morris Manning & Martin LLP Lindsey Lonergan, Deputy General Counsel, Navicent Health
- Identify metrics that compliance officers can develop to demonstrate the effectiveness of their compliance programs to board members, senior leaders, enforcement agents, and others
- Discuss how compliance officers can help board members and compliance committee members understand their roles and responsibilities
- Explore how to best make work force members aware of what types of issues should be reported to the compliance department
- 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
11:00 AM - 11:15 AMNetworking Break Coffee & Hot Tea available
11:15 AM - 12:15 PMBreakout Session 2#201201: 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
General Compliance#202202: 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
- 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#203203: Privacy Breach Response Blaine Kerr, Chief Privacy Officer, Jackson Health System Gregory Kerr, Managing Director, Ankura Consulting Group, LLC
- 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
- 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
12:15 PM - 01:15 PMNetworking Lunch
01:15 PM - 02:15 PMBreakout Session 3#301301: False Claims Act Liability in Post-Acute Care Claudia Reingruber, Shareholder, Saltmarsh, Cleaveland & Gund LT Lafferty, Partner, Holland & KnightGeneral Compliance#302302: Risk Management for Compliance Officers Steven Ortquist, President, Arete Compliance Solutions, LLC Scott Grubman, Partner, Chilivis, Cochran, Larkins & Bever
General Compliance#303303: Privacy and Compliance, HIPAA State Law and GDPR Iliana Peters, Shareholder, Polsinelli, PC Uday Ali Pabrai, CEO, ecfirstGeneral Compliance
- 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
02:15 PM - 02:45 PMNetworking Break Snack along with Coffee, Hot Tea & Sodas available
02:45 PM - 03:45 PMBreakout Session 4#401401: HHS Health Industry Cyber Security Practices - Managing Threats and Protecting Patients Erik Decker, CISO and Chief Privacy Officer, University of Chicago Hospitals Ty Greenhalgh, Managing Member, Cyber Tygr
General Compliance#402402: Lessons from Stark Investigations David Glaser, Shareholder, Fredrikson & Byron PA Matthew Krueger, United States Attorney, Eastern District of Wisconsin
- 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#403403: A Sensible Approach to Global Security and Data Privacy Michelle Caswell, Principal, Coalfire
- 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.
- 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
03:45 PM - 04:00 PMNetworking Break Snacks, Coffee, Hot Tea and Sodas available
04:00 PM - 04:30 PMCompliance Keynote Address
Tuesday, November 5
07:15 AM - 08:15 AMContinental Breakfast
08:15 AM - 08:30 AMOpening Remarks Tuesday
08:30 AM - 09:30 AMCompliance Keynote Address
09:30 AM - 09:45 AMNetworking Break Coffee & Hot Tea available
09:45 AM - 10:45 AMBreakout Session 1#501501: Delegate Oversight and Protecting PHI Erin Miskell, Consultant, ATTAC Consulting Group LLC
General Compliance#502502: Root Cause Analysis Workshop Rosalind Cordini, Senior Vice President/Director of Compliance Services, Coker Group Dwight Claustre, President/CEO, Healthcare Compliance Professional, 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#503503: Confidentiality of Substance Use Disorder Records Karolina Austin, HIM Director/ Privacy Officer, Operation PAR
- 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
- 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
10:45 AM - 11:15 AMNetworking Break: Last Chance to Visit the Exhibit Hall Coffee and Hot Tea available
11:15 AM - 12:15 PMBreakout Session 2#601601: Controlled Substance Crisis: A Holistic Approach for Hospitals Tamara Mattox, Healthcare Consulting Sr. Audit Manager, Crowe
General Compliance#602602: Compliance and Risk Assessments Uday Ali Pabrai, CEO, ecfirst Marcie Swenson, President, Skyda Law Group
- 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#603603: Quality Payment Program Raul Ordonez, Hospital Compliance Ofcr, Jackson Health System Michael Stearns, Chief Executive Officer, Apollo HIT, LLCGeneral Compliance
- Step through compliance mandates & standards for risk assessment
- Examine core components for a comprehensive and thorough risk assessment exercise while walking thru a sample risk assessment report to understand key sections such as a Corrective Action Plan (CAP)
- Understand how to integrate a technical vulnerability assessment & penetration test within the scope of a risk assessment and walk through a sample risk assessment report to understand key sections such as a Corrective Action Plan (CAP)
12:15 PM - 01:15 PMNetworking Lunch
01:15 PM - 02:15 PMBreakout Session 3#701701: Ask the Stark Law Professionals Charles Oppenheim, Partner, Hooper Lundy Bookman, PC Lester Perling, Partner, Nelson Mullins Broad and Cassel Robert Wade, Partner, Barnes & Thornburg LLP
General Compliance#702702: The Opioid Crisis and Compliance Amy Boring, Attorney, King & Spalding LLP Michelle Seegers, Pharmacist & Regulatory Compliance Consultant, ProtivitiGeneral Compliance#703703: Navigating Parallel Investigations, Criminal, Civil, State and Federal Sally Blinken, Counsel, Lupkin PLLC Edward Baker, Counsel, Constantine Cannon 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
- 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.
02:15 PM - 02:30 PMNetworking Break
02:30 PM - 03:30 PMBreakout Session 4#801801: Patient Support Services and False Claims Act Risks Winston Chan, Partner, Gibson, Dunn & Crutcher LLP William Harrington, Partner, Goodwin Procter LLP Joshua Hill, Parnter, Sidley Austin LLP
General Compliance#802802: Enforcement and Compliance, Retail Pharmacy Selina Coleman, Partner, Reed Smith LLP Daniel Fitzgerald, Senior Counsel, Commercial Litigation Dept. , Walgreen Co.
- 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#803803: Clinical Trial Enforcement and Compliance F. Lisa Murtha, Senior Managing Director, Ankura Consulting, Inc. Toby Boenig, Vice President and Chief Compliance Officer, UTMB HealthGeneral Compliance
- 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
03:30 PM - 03:45 PMNetworking Break
03:45 PM - 04:45 PMOperationalizing Compliance Through Data Analytics Jim Passey, Vice President, Chief Audit & Compliance Officer, HonorHealth Vince Walden, Partner, Ernst & Young - Understand leading frameworks for operationalizing compliance - Leading analytical techniques and practical case examples - Analytics considerations and pitfalls to avoid when deploying your program
Wednesday, November 6
08:30 AM - 10:00 AMBreakout Session 1#POSTPost Conference#W1W1: SNF Mandatory Compliance is Here: Lessons Learned from CIAs Tamar Abell, CEO, TBA Consultant Claudia Reingruber, Shareholder, Saltmarsh, Cleaveland & Gund
General Compliance#W2W2: 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 Martinez, Board Member, Parkland Health & Hospital System Kathleen Murphy, Managing Director, Alvarez & Marsal
- 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#W3W3: Enforcement and the Opioid CrisisGeneral Compliance
- 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.
10:00 AM - 10:15 AMNetworking Break Coffe & Hot Tea available
10:15 AM - 11:45 AMBreakout Session 2#W4W4: Privilege and Compliance Nicholas Merkin, CEO, CompliagentGeneral Compliance#W5W5: 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 Odell Guyton, Managing Director, Klink & Co. Inc
General Compliance#W6W6: Medical Necessity and the False Claims Act JD Thomas, Partner, Waller Lansden Dortch & Davis, LLP Jeffrey Dickstein, Partner, Phillips & Cohen LLPGeneral Compliance
- Learn hands-on best practices from a current in-house compliance counsel, a leading 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
11:45 AM - 12:30 PMLunch (On Your Own)