2019 Healthcare Enforcement Compliance Conference

1. 21st Century Data and Detection: Implementing a World-Class Global Continuous Monitoring Program to Detect FCPA and Kickback Risks Before They Become Systemic

   2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Parth Chanda, Jeff Klink  | November 06, 2019 

   • 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

2. Enforcement and the Opioid Crisis

   2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Gary Cantrell, Jill Furman, Katherine Payerle  | November 06, 2019 

   • 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

3. Medical Necessity and the False Claims Act

   2019 Healthcare Enforcement Compliance Conference  | Presenter(s): J.D. Thomas, Jeffrey Dickstein, Rob McAuliffe  | November 06, 2019 

   • Medical necessity cases are very much alive in the FCA world, though the environment is everchanging. 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

4. Privilege and Compliance

   2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Nicholas Merkin, Anna Grizzle  | November 06, 2019 

   • 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

5. Mandatory Compliance is Here: Lessons Learned from CIAs

   2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Tamar Abell, Claudia E. Reingruber  | November 06, 2019 

   • Review of the RoP for Skilled Nursing Home mandatory compliance program and how it will affect 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

6. The Parkland Health & Hospital System Story: How We Learned, the Hard Way, What Every Healthcare Organization Must Know

   2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Mary S. Findley, Robert D. Martinez, Kathleen Murphy, Felicia Heimer  | November 06, 2019 

   • 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

7. Ask the Stark Law Professionals (2019 Healthcare Enforcement Compliance)

   2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Charles Oppenheim, Lester Perling, Robert Wade  | November 05, 2019 

   • 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

8. Confidentiality of Substance Use Disorder Records

   2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Karolina Austin  | November 05, 2019 

   • 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

9. Delegate Oversight and Protecting PHI

   2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Erin Miskell  | November 05, 2019 

   • 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

10. Enforcement and Compliance: Retail Pharmacy

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Selina Coleman, Daniel P. Fitzgerald  | November 05, 2019 

    • 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

11. Controlled Substance Crisis: A Holistic Approach for Hospitals

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Tamara Mattox  | November 05, 2019 

    • 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

12. Clinical Trial Enforcement and Compliance

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Toby Boenig, Craig A. Conway  | November 05, 2019 

    • 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

13. Compliance and Risk Assessments: Prepared?

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Uday Ali A. Pabrai  | November 05, 2019 

    • 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

14. General Session: OCR Update (2019 Healthcare Enforcement Compliance)

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Roger Severino  | November 05, 2019 

    • 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

15. General Session: Operationalizing Compliance Through Data Analytics

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Vincent M. Walden, Jim Passey, Lee Tiedrich, Geoff Hymans  | November 05, 2019 

    • Understand leading frameworks for operationalizing compliance

    • Leading analytical techniques and practical case examples

    • Analytics considerations and pitfalls to avoid when deploying your program

16. Patient Support Services and False Claims Act Risks

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Winston Chan, William J. Harrington, A. Marisa Chun  | November 05, 2019 

    • 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

17. Quality Payment Program (QPP)

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Raul Ordonez, Michael Marron-Stearns  | November 05, 2019 

    • 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

18. Root Cause Analysis Workshop

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Rosalind Cordini, Dwight Claustre  | November 05, 2019 

    • 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

19. The Opioid Crisis and Compliance

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Amy Boring, Michelle Seegers, julia Russell  | November 05, 2019 

    • 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

20. Navigating Parallel Investigations: Criminal, Civil, State, and Federal

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Sally Blinken, Edward A. Baker  | November 05, 2019 

    • 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

21. Building an Effective Investigative Team (2019 Healthcare Enforcement Compliance)

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Tamra L. Smith, Michael D. Sandulak, Matt Tormey  | November 04, 2019 

    • 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

22. Due Diligence and Compliance

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Edgar D. Bueno, Lindsey Lonergan  | November 04, 2019 

    • 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

23. False Claims Act Liability in Post-Acute Care

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Claudia E. Reingruber, Latour "LT" Lafferty  | November 04, 2019 

    • 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

24. A Sensible Approach to Global Security and Data Privacy

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Michelle Caswell, Juan Carlos (JC) Palacio  | November 04, 2019 

    • Learn from a global privacy attorney and a cyber security 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

25. Collateral Consequences to Audits and Adverse Enrollment Actions

    2019 Healthcare Enforcement Compliance Conference  | Presenter(s): Richard R. Burris, Andrew B. Wachler  | November 04, 2019 

    • 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 (TPE) 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