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Course Details

Course Information
  • smart_display Format

    On-Demand

  • signal_cellular_alt Difficulty Level

    Intermediate

  • work Practice Area

    Health

Date & Time
  • event Date

    Wednesday, September 4, 2024

  • schedule Time

    1:00 p.m. ET./10:00 a.m. PT

  • timer Program Length

    90 minutes

Credit Information

  • This 90-minute webinar is eligible in most states for 1.5 CLE credits.

$297.00
CLE
ALL

This CLE webinar will examine when healthcare providers should consider self-disclosure of possible False Claims Act (FCA) violations to the DOJ in addition to HHS-OIG. The panel will examine recent DOJ FCA settlements with healthcare providers to address the risks and benefits of self-disclosure to the DOJ and to determine what actions were taken by the providers that were considered favorable by the DOJ and led to a reduced damages calculation.

Faculty

Denise M. Barnes
Member
Bass Berry & Sims Plc

Ms. Barnes counsels clients in high-stakes matters related to fraud allegations, including in healthcare, federal contract procurement, and securities and financial services. A former trial attorney with the U.S. DOJ, she has extensive experience handling issues related to compliance, white-collar and regulatory investigations, and complex commercial litigation. Ms. Barnes represents businesses in public and non-public investigations, regulatory inquiries, and proceedings involving federal and state agencies. She frequently assists clients navigating government investigations related to allegations arising under the False Claims Act, Anti-Kickback Statute, Stark Law, and FIRREA. Ms. Barnes is also a recognized leader in her practice, frequently participating in various speaking engagements and authoring articles on critical topics such as cybersecurity, government contract billing, financial data rights, and developments related to the FCA. 

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Anjali N.C. Downs
Member
Epstein Becker & Green PC

Ms. Downs’ commanding knowledge of the False Claims Act, Anti-Kickback Statute, and Stark Law safeguards healthcare clients’ products, services, and ensures operational success. Clients, which range from providers to device manufacturers and ambulatory centers, depend on her in-depth understanding of the fraud and abuse laws and what triggers government authorities to take exception. As regulatory counsel, Ms. Downs aligns clients’ risk tolerance with commercial opportunities to create a path forward. As value-based care expands, she is preparing clients to meet related challenges on fraud and abuse laws and the interactions by and between healthcare referral sources.

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Description

Recent DOJ settlements (e.g., Baptist Health System Inc. and Innovasis Inc.) demonstrate the importance of healthcare providers considering self-disclosure of potential FCA violations, not only to HHS-OIG, but also to the DOJ to mitigate the potential of future liability. Even when settling with HHS-OIG, without a DOJ release of FCA liability, healthcare providers may still be open to FCA qui tam suits for the same alleged FCA violations disclosed to HHS-OIG.

The DOJ has a strong interest in incentivizing companies and individuals to voluntarily disclose possible FCA violations and extends "credit" to those who do so during the resolution of the FCA case. Such "credit" refers to the DOJ's discretion to reduce penalties or damages from the treble damages required by the FCA to 1.5-2 times the amount of damages under certain circumstances as demonstrated in recent settlements.

Listen as our expert panel discusses when healthcare providers should contemplate self-disclosure to the DOJ for possible FCA violations. The panel will discuss the DOJ self-disclosure protocol as compared to the HHS-OIG self-disclosure protocol and address the possible risks and benefits of self-disclosure to the DOJ by examining recent DOJ FCA settlements with healthcare providers.

Outline

  1. Introduction
    1. FCA overview
    2. Evaluating when to make a self-disclosure
  2. HHS-OIG self-disclosure vs. DOJ self-disclosure
    1. Agency protocol
    2. Risks and benefits of self-disclosure
  3. Recent DOJ FCA settlements and the impact of self-disclosure
    1. Innovasis Inc. (May 2024)
    2. Baptist Health System Inc. (May 2024)
    3. Lee Moffitt Cancer Center & Research Institute Hospital (Jan. 2024)
    4. Oliver Street Dermatology Management Inc. (Sept. 2023)
    5. Others
  4. Practitioner takeaways

Benefits

The panel will review these and other important considerations:

  • When should counsel and their healthcare provider clients consider self-disclosure to HHS-OIG? To the DOJ?
  • What are the risks and benefits associated with self-disclosure to the DOJ?
  • What can counsel learn from recent DOJ FCA settlements as to when to voluntarily disclose possible FCA violations to the DOJ?