Polsinelli’s Health Care attorneys use their knowledge and experience to help clients identify, avoid, and (when necessary) resolve difficult regulatory compliance issues. Our top priority is to assist clients with avoiding compliance problems in the first instance. In this regard, we regularly advise our clients on structuring transactions and day-to-day operations that maximize the business goals while minimizing the compliance risks.

We also recognize that potential noncompliance (whether actual or just alleged) can occur. We provide practical and effective strategies to clients who have identified compliance problems. Our solutions are based upon our experiences in law and regulations, our deep understanding of the health care industry, our knowledge of how the governmental agencies “think” about compliance issues, and what actually “works” to reduce risk and resolve issues.

Our compliance work includes:
  • Development of joint venture structures that address business realities and legal requirements
  • Counseling clients on operational and contract issues that are impacted by fraud and abuse laws
  • Ensuring that complex health care transactions comply with all applicable state and federal law including but not limited to the federal Anti-kickback Statute, the Stark law, state self-referral laws, licensure laws, and reimbursement requirements
  • Development of physician compensation models and programs
  • Resolution of OIG and DOJ investigations and audit
  • Negotiation, revision, and implementation of OIG integrity agreements
  • Requests for Advisory Opinions from the OIG
  • Practical analysis and solutions for potential Stark noncompliance
  • Preparation and submission of Stark Self-Disclosures
  • Internal reviews into whistleblower claims and allegations of noncompliance, including strategies for bringing finality to potential instances of noncompliance
  • Advice and counseling regarding identified overpayments, including practical methods for repaying overpayments in a manner that minimizes risk of unwarranted governmental scrutiny
  • Responding to state and federal surveys and inspections, including developing plans of correction (and appeals, when strategic)
  • Advising manufacturers, providers, and physicians regarding the Physician Payment Sunshine Act
  • Assessment and development of a variety of operational programs that potentially implicate the Beneficiary Inducement Statute
  • Responding to inquiries from state licensure boards
  • Responding to all varieties of Medicare and Medicaid auditors
  • Coordinating and assisting with complex coding, billing and reimbursement issues
  • Troubleshooting Medicare and Medicaid enrollment issues
  • Solutions for issues related to individuals who are excluded from federal health care programs
  • False Claims Act
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