P1 Clinical Research and Compliance
Speakers: Kelly Willenberg, Ryan Meade
- Define research compliance in clinical research
- Analyze regulatory regulations in research compliance
- Evaluate current enforcement and challenges sites face
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P2 Whistleblowers: Who Are They and What Makes a Good Whistleblower Case
Speakers: Jacklyn DeMar, Michael Ronickher, Renee Brooker, David Jochnowitz
- Internal reporting and response to non-compliant activity
- Understand why employees become whistleblowers and keys to recognizing potential whistleblower risk
- Key factors for actionable whistleblower cases
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P3 Privacy Breach Response
Speakers: Gina Greenwood, Joan Podleski
- Covered entity and business associates and breach response
- Obligations of covered entity and business associate
- Comprehensive, accurate and timely reports to the covered entity
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P4 Anatomy of a FCA Case
Speakers: Amy Easton, Gabriel Imperato, Jordan Kearney
- The investigation phase: Subpoenas/CIDs, data analysis, witness interviews, and more
- The negotiation phase: Initiation, ADR, scope of the release, damages, and other issues
- The resolution phase: Settlement agreements, individual liability, CIAs/OIG, and relator issues
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P5 Managed Care Enforcement and Compliance
Speakers: Dan Meron, Sarah Kessler, Teresa Mason
- Managed care fraud and enforcement
- Managing compliance risks in managed care: Risk adjustment and best practices
- Education and training and managed care compliance
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P6 Criminal and Civil Enforcement and Telehealth
Speakers: Catherine Wagner, Jonathan Porter
- 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 and telehealth
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P7 Negotiating and Mediating an FCA
Speakers: Michael Theis, Sara Vann, Steve Altman
- Negotiating and mediating False Claims Act cases
- Effective settlement and mediation strategies
- Drafting False Claims Act settlement agreements
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Handout
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P8 Clinical Research and Enforcement 2023
Speakers: Linda Malek, Lisa Murtha, Clint Narvar
- Latest developments in clinical research enforcement actions
- Common compliance risks for clinical research
- Best practices for managing clinical trial risk
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P9 EKRA and Kickback Enforcement
Speakers: James Hayes, Tony Maida
- EKRA prohibitions for recovery and laboratory organizations
- Criminal and civil developments in application of EKRA
- EKRA and the Anti-Kickback Statute
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P10 Information Blocking
Speakers: James Hansen, Scott Stiefel
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P11 Enforcement, Compliance Officer, and General Counsel
Speakers: Laura Ellis, Linda Epstein, Rebekah Stewart
- Effective compliance and management: General counsel and compliance officer
- OIG’s perspective on the role of general counsel and compliance officers
- Effective compliance practices and priorities
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P12 Enforcement and Private Equity
Speakers: James Sheehan, Kirk Ogrosky, Matthew Tormey
- Private equity participation in the healthcare industry
- Basis for liability for private equity
- Managing risk for private equity investors
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GS1: Evaluation and Compliance Program Effectiveness - DOJ, OIG & Industry Benchmarks
Speaker: Lauren Kootman, Tom O'Niel, James Sheehan
Handout
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Handout 4
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Handout 6
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GS2: OIG Update
Speaker: Robert DeConti
No Presentation
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101 Beneficiary Inducement and FCA Liability
Speakers: Ben Wallfisch, Kim Stanger
- Prohibitions against beneficiary inducement for healthcare services
- False claims and civil money penalty liability
- OIG fraud alerts and authorities on prohibited beneficiary inducement, including criminal and civil liability for routine waiver of co-payments
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102 Conflicts of Interest in Healthcare
Speaker: Judy Ringholz, Aaron Narva
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103 Post Pandemic Enforcement
Speakers: Colin Huntley, Justin Woodard
- Status of post-pandemic enforcement actions
- Payment Protection Program and Provider Relief Fund Liability
- Responding to Administrative Actions to Recover Pandemic Funds
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201 Enforcement, Compliance, and Long-Term Care
Speakers: David Hoffman, Ilene Warner-Maron, Paul J. Mahoney, Susan Lynch
- Criminal and civil enforcement actions
- Common basis for long term care liability
- Managing long term care risk
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202 FCA and Liability for Risk Adjustment
Speakers: Alex Oliphant, Edward Baker
- Origins of liability for risk adjustment
- State of settlements and litigation
- Recent final RADV rule and audit liability
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203 FCA Developments
Speakers: Brian Bewley, Jamie Yavelberg, Jonathan Diesenhaus
- Review of recent False Claims Act Supreme Court decisions
- Latest developments in False Claims Act liability and damages
- Dismissal and Summary Judgment in False Claims Act cases
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301 Internal Investigations, Repayment, and Self-Disclosure
Speakers: Candace Ashford, Ellen Gallagher, Thomas Barnard
- Authority and practical considerations for conducting internal investigations
- Methods and best practices for internal investigations
- Evaluation and report, potential self-disclosure, and resolution of compliance matters
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302 Enforcement, Compliance, and Data Analytics
Speaker: Greg Becker, Nora Witek, Mandy Asgeirsson
- Overview of OIG administrative enforcement: Civil Monetary Penalties and Exclusion
- Data analytics as an OIG enforcement tool
- Cast study and Discussion
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303 Hospital and Physician Compensation and Value-Based Arrangements
Speakers: Charles B. Oppenheim, Raul Ordonez, Bob Wade
- Legacy of liability for hospital/physician compensation arrangements
- Emerging compensation arrangements including value-based/bundled arrangements: Legal and regulatory requirements
- Compensation arrangements and hospital/physician alignment strategies
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401 Medical Necessity: Criminal and Civil Enforcement
Speakers: Alison Rousseau, Anna Grizzle
- Medical necessity and criminal and civil enforcement
- Compliance effectiveness and medical necessity
- Effective response to medical necessity compliance matters
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402 OIG Compliance Program Guidance
Speakers: Amanda Copsey, Laura Ellis
- Discuss the vision of the updated General Compliance Program Guidance (GCPG) as part of the OIG’s push to modernize its publicly available resources;
- Provide input on the contents of the GCPG;
- Highlight points of particular interest; and
- Preview the role of upcoming industry-specific CPGs (ICPGs).
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403 Medicaid Fraud Enforcement
Speakers: David Tanay, Jack Wenik
- Medicaid fraud control unit collaboration and coordination
- Medicaid fraud identification, investigation, and multi-state prosecutions
- Government and defense perspectives on Medicaid fraud investigation
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General Session #3
No Presentation
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501 Federal Administrative Sanctions
Speakers: Geoff Hymans, Greg Demske, Jonathan Culpepper
- Understand OIG enforcement sanctions, remedies, and appeals
- Appreciate differences from available CMS Sanctions
- Identify new CMS program integrity rules and authorities
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502 Hot Topics in Fraud and Abuse
Speakers: Brian Martens, Felicia Heimer, Colette Matzzie
- Latest developments in fraud cases
- Kickback and Stark liability
- Medical necessity, risk adjustment, and common false claims
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503 Compliance and Due Diligence
Speakers: Betty Kinsey, Charles Overstreet
- Compliance-centered due diligence process
- Transaction structure and scope of due diligence, best practices for monitoring post-transaction compliance
- Case studies, practice tips, and common risks and due diligence
No Presentation
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601 Published Guidance and Compliance Program Effectiveness
Speakers: Edward Case, Judy Ringholz
- 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
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602 CIA's and IRO's
Speakers: Gary Keilty, Steven Ortquist
- Corporate integrity agreements implementation and coordination with OIG Monitor
- Obligations and role of an IRO
- Keys to successful IRO engagements
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603 Enforcement, Compliance, and Behavioral Health
Speakers: Andrew Schulke, Crane Pomerantz
- Eliminating Kickbacks in Recovery Act and its application to behavioral health
- Criminal and civil federal and state enforcement against mental health and substance abuse treatment facilities and sober homes
- Common arrangements and kickback liability
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701 Response to Civil Investigative Demands
Speakers: Edgar Bueno, Jordan Kearney
- Legal basis and scope of Civil Investigative Demands
- Civil Investigative Demand and subpoenas
- Civil Investigative Demands for e-data and response
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702 Enhanced Enforcement of Hospital Transparency Rule
Speakers: Christine Worthen, Raul Ordonez
- Overview of the price transparency rule
- Review CMS enforcement efforts
- Compliance Tips
- Upcoming changes
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703 Fraud and Compliance in Retail Pharmacy
Speakers: Drew Walgreen, Lisa Murtha
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801 Handling a Criminal Healthcare Fraud Case
Speakers: Kathleen Cooperstein, Thomas Tynan
- Emerging criminal enforcement trends
- Role of data in criminal cases
- Unique aspects of responding to criminal enforcement actions
No Presentation
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802 Internal Investigations and Remedial Actions
Speakers: Dwight Claustre, Rosalind Cordini
- Discuss the importance of having a structured process for conducting an investigation
- When should legal counsel be brought into the investigation
- Identify mitigation strategies based on the facts as developed from the investigation
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803 Enforcement and Compliance in Clinical Laboratories
Speakers: Felicia Heimer, Darrell Contreras
- EKRA, AKS and Clinical Laboratories
- Marketing Activities and Compliance Risk
- Identification and Response to EKRA and AKS Compliance Risk
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GS4 Anti-kickback Statute 50 Year Anniversary
Speakers: Fritz Scanlon, Laura Oberembt, Sandy Teplitzky, Susan Edwards
- Discuss the 50-year history of legislative and regulatory changes to the Federal anti-kickback statute and its exceptions and safe harbors
- Understand the evolution of AKS-related case law and currently litigated issues
- Provide an overview of the development of the advisory opinion process and highlight some notable advisory opinions
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