Spotlight on Healthcare and Pharma

Part I: Newest Trends of Enforcing and Defending Claims under the Anti-Kickback Statute and Medicare Advantage Plans

January 24, 2024 9:00am

Jay Dewald
Partner | Head of Healthcare Investigations
Norton Rose Fulbright US LLP

Krysten Rosen Moller
Covington & Burling LLP

Kevin Lamb
Wilmer, Cutler, Pickering, Hale & Dorr LLP

Miriam Glaser Dauermann
Acting Assistant Chief, Criminal Division, Healthcare Fraud Unit
USAO, Eastern District of NY

John Kokkinen
Senior Associate General Counsel
UnitedHealth Group
Former AUSA, Criminal Health Care Fraud Coordinator, USAO District of MN

Anti-Kickback Statute and Causation

  • Analyzing the implications of the 8th Circuit decision in United States ex rel. Cairns v. D.S. Medical LLC (July 26, 2022); United States v. Teva Pharmaceuticals 1.20-cv-11548 (D. Mass)(July 14, 2023); United States v. Regeneron Pharmaceuticals (D. Mass)(September 27 2023); and other recent decisions and petitions for certiorari regarding causation in FCA/AKS cases
    • Incorporating takeaways from these rulings into future litigation strategies
  • Examining the causation defenses from recent cases
  • Considering venue selection and pleadings, considering the circuit splits on causation
  • Appreciating the impact of HHS OIG’s revisions to the regulations implementing the AKS

Medicare Advantage Plans:
Analyzing the latest DOJ investigations, enforcement activity and settlements involving Medicare Advantage plans in connection to:

  • Offering kickbacks to healthcare professionals and the waiver of co-payments
  • Risk adjustment and diagnostic coding fraud
  • Inappropriate restriction of beneficiary access to medically necessary care
    • Overzealous diagnostic testing based off available coverage and not medical necessity
  • Submitting inaccurate information about the health status of MA plan beneficiaries