1 THE AMERICAN LAW INSTITUTE Continuing Legal Education Strategies for Avoiding and Responding to Health Care Fraud and Abuse Claims May 6, 2015 Telephone Seminar/Audio Webcast Strategies for Avoiding and Responding to Health Care Fraud and Abuse Claims PowerPoint Presentation By Thomas W. Beimers Faegre Baker Daniels LLP Minneapolis, Minnesota Amy F. Lerman Epstein Becker & Green, PC Washington, D.C. Robert D. Stone Alston & Bird LLP Atlanta, Georgia Michaela ("Kayla") Tabela Locke Lord LLP Boston, Massachusetts 2 Strategies for Avoiding and Responding to Health Care Fraud and Abuse Claims Wednesday, May 6, 2015 12:00 – 1:30 pm Eastern Telephone Seminar Audio Webcast INTRODUCTION OF SPEAKERS • Thomas W. Beimers, Faegre Baker Daniels LLP (Moderator) • Robert D. Stone, Alston & Bird LLP • Amy Lerman, Epstein Becker & Green, P.C. • Michaela (“Kayla”) Tabela, Locke Lord LLP 2 3 INTRODUCTION OF TOPICS FOR TODAY • Federal Anti-Kickback Statue – Recent AKS enforcement efforts and regulatory changes • Novartis case and switching arrangements • OIG special advisory on pharmacy co-payment coupons • Safe harbor amendments • Federal False Claims Act (FCA) – “Reverse” False Claims – 60-Day Overpayment Rule • • Continuum and Keltner cases Federal Physician Self-Referral Law (“Stark Law”) – Stark litigation update: Tuomey & Halifax cases – Stark law enforcement and compliance trends – Update on the CMS self-referral disclosure protocol • Summary of Government Enforcement, Investigations, and Risk Mitigation – Understanding the Enforcement Environment – Risk mitigation and key compliance considerations 3 Anti-Kickback Statute Michaela (“Kayla”) Tabela, Locke Lord LLP 4 Overview • 42 U.S.C. § 1320a-7b(b) • Prohibits offering, paying, soliciting or receiving anything of value to induce or reward referrals or generate Federal health care program business • Referrals can be from anyone • Any item or service • Any Federal health care program 5 Regulatory Changes • Criminal Statute: Government must show that defendant acted with requisite intent (“knowingly and willfully”) – Specific Intent? • Post-ACA: “With respect to violations of this section, a person need not have actual knowledge of this section or specific intent to commit a violation of this section.” – One Purpose Test • Safe Harbors 6 5 Penalties • Criminal – Fines up to $25,000 per violation – Up to a 5 year prison term per violation • Civil/Administrative – Liability under the False Claims Act – Civil monetary penalties (“CMPs”) and program exclusion – Potential $50,000 CMP per violation – Treble damages 7 U.S. ex rel. Bilotta v. Novartis Pharmaceuticals Corp. • In 2011, a whistleblower (former employee) filed an action under the False Claims Act alleging that “from January 2002 through at least November 2011, Novartis systematically bribed doctors to induce them to prescribe drugs from Novartis’s cardiovascular division for their patients.” 8