As state and federal governments increase regulation, expand enforcement efforts and intensify scrutiny of healthcare industry transactions and operations, stakeholders are facing increased risk and potentially devastating consequences arising from fraud and abuse matters. Fraud and abuse compliance remains one of the most significant areas of risk facing providers, and Kutak Rock has the depth and breadth of experience necessary to address these challenges with our clients.  Our team understands the complexities involved in compliance and investigations.  We have extensive experience providing comprehensive guidance on these matters and developed strong relationships with regulators and investigators that allows us to help clients navigate the complex and critical processes.  Our representation has included clients across the full spectrum of the industry, such as publicly traded, privately held, not-for-profit, and governmental entities, hospitals, health plans, long-term care facilities, managed care organizations, physician organizations, university systems, pharmaceutical manufacturers, dialysis suppliers, and others involved in healthcare delivery.

Fraud and abuse compliance requires consistent and vigilant oversight.  When issues arise, we have been called upon to both resolve matters internally and, when necessary, coordinate responses and resolutions with regulators and oversight authorities.  We have developed strong relationships with representatives of the Department of Justice and Office of Inspector General, as well as state officials in various Offices of Medicaid Inspector General and State Attorneys General. 

Kutak Rock is well-versed in the regular subjects of these inquiries:

• Statutory and Regulatory Frameworks
  
  • Federal and state Anti-Kickback Statutes
  • Civil Monetary Penalties Law
  • Stark Law and state Self-Referral Laws
  • Licensure prohibitions related to fraud and abuse
• Compensation, Remuneration, and Reimbursement
  
  • Physician compensation structures
  • Medicare and Medicaid compliance
  • Private third-party payor requirements
  • Physician ownership and related-entity matters
  • Beneficiary inducement concerns
  • Safe Harbor structuring
  • Enrollment activities
• Inquiries and Investigations
  
  • Conducting internal investigations
  • Performing regular corporate compliance audits
  • Coordinating responses to internal and external investigations
  • Drafting and negotiation of Corrective Action Plans, Corporate Integrity Agreements and related settlement agreements
  • Challenging healthcare program exclusions and other issues related to the List of Excluded Individuals/Entities