| Title: AI:
Zesty Topics Involving the False Claims Act
Presenter: Rachel Rose, JD, MBA
Time: 53.34 minutes
Description:
The False Claims Act remains the federal government's number one vehicle for recovering funds for the federal fisc. With two Supreme Court opinions issued in 2023, the impact on compliance and the litigation landscape is significant. This webinar highlights key issues that litigators and compliance officers should consider, as well as cases that are making an indefatigable mark.
Objectives:
- Understand the False Claims Act and fraud enforcement.
- Learn about recent cases and the downstream impact on compliance initiatives.
- Appreciate the DOJ enforcement initiatives and the impact on the healthcare industry.
Key Topics:
- Brief overview of the False Claims Act
• Fraud enforcement
• DOJ's cybersecurity initiative announcement
• First civil cyber-fraud initiative settlement
• DOJ – Jellybean settlement
- False Claims Act hot topics and notable cases
• Biogen Inc. agrees to pay $900 million to settle allegations related to improper physician payments.
• SC physician and practice agree to pay over $585,000 to settle laboratory kickback allegations.
• Artificial Intelligence (AI) and machine learning (AI/ML) enabled medical devices
• AI
- Recent Supreme Court cases and the relevance to meeting the 9(b) standard
- FRCP 9(b) requirements in an FCA case
• FRCP 9(b)
• FCA pleadings must conform to the heightened pleading standard.
• What does "pleading with particularity" mean? Historical and still relevant fifth circuit opinions
• Always consider FRCP 12(B)(6).
- Learn about the federal government's position in its amicus briefs over the past decade.
- Understand the nuances of what is required in terms of "proof" in order to meet 9(b), even at the pleading stage, across different circuits.
• 9(B) "proof" across the circuits
• Circuit highlights
• Circuit highlights (10 th and 11 th )
- The role of compliance in mitigating False Claims Act liability from both a civil and criminal vantage point.
• HHS - OIG compliance requirements
• DOJ - Evaluation of corporate compliance programs (updated 2023)
• DOJ issues guidance on FCA matters and updates Justice Manual
Speaker Rachel V. Rose, JD, MBA - Principal. https://www.rvrose.com/ Ms. Rose has a unique background. Throughout her career, she has accumulated knowledge in a multitude of fields, with an emphasis on various facets of healthcare. Her experiences include: - working on Wall Street and at one of the "Big Four" consulting firms;
- producing for the Chairman of the Reform and Oversight Committee on Capitol Hill;
- interning at the Department of Health and Human Services;
- compiling policy papers at the Royal College of Nursing in London;
- consultative work as a top performing representative for the pharmaceutical and medical device industry;
- clerking for the Honorable Linda R. Allan (6th Judicial Circuit, FL).
Prior to opening her law firm, she was Director of Business Development and Assistant General Counsel for a healthcare advisory company. She is extensively published and presents on a variety of healthcare, False Claims Act and securities law topics including: cybersecurity, qui tam, physician reimbursement, ICD-10, access to care, anti-kickback and Stark laws, U.S. Supreme Court cases impacting the medical device industry, international comparative healthcare laws, and the HIPAA/the HITECH Act.
Presently, she is the immediate past-chair of the Federal Bar Association's Corporate and Associations Counsel Division (2014-2016), one of eighteen lawyers, who serves on the Federal Bar Association's Government Relations Committee. Ms. Rose has co-authored The American Bar Association's books - The ABCs of ACOs and What Are International HIPAA Considerations?, as well as being a co-editor of American Health Lawyers Association’s Enterprise Risk Management Handbook (2nd Edition). Ms. Rose is also an Affiliated Member of the Baylor College of Medicine's Center for Health Policy and Medical Ethics, where she teaches bioethics and is on the University of Houston Law School's Healthcare Law Advisory Board. Education - Bachelor of Arts- History (The Pennsylvania State University)
- Master of Business Administration (Vanderbilt University)
- Doctorate of Jurisprudence (Stetson University College of Law); Editor, The Journal of International Law and Aging
Honors and Awards - National Scribes Award
- The William F. Blews Pro Bono Service Award
- Federal Bar Association Fellow
- Named to Texas Bar College
- National Women Trial Lawyers Association - Top 25,, 2018 and 2019
- Houstonia Magazine's Top Lawyers- Healthcare Law, 2018 and 2019
License
| |
