Healthcare Regulatory Compliance

Whether it's day-to-day operational issues or long-term strategic matters, our healthcare attorneys work to understand our clients' objectives and then develop effective strategies for achieving their goals. The depth and breadth of our regulatory experience is central to our mission.

The confidence our clients place in us is based on our more than 50 years of experience with healthcare regulatory law and the fact that many of the solutions we have developed are now models used throughout the healthcare industry.

Federal Regulations

Healthcare clients rely on Waller's compliance and operations team for assistance with a variety of federal regulations, including:

• Medicare enrollment and reimbursement
• Stark, state and federal Anti-Kickback compliance
• The Emergency Medical Treatment and Active Labor Act

Mergers, Acquisitions and Joint Ventures

Waller attorneys are familiar with Joint Commission standards and numerous other regulations. Our healthcare attorneys have extensive experience in structuring mergers, acquisitions and joint ventures to ensure compliance with federal and state regulations.

We advise clients with respect to innovative models for hospitals and physicians to work together, including through clinical co-management agreements and foundation models, within physician-hospital organizations and accountable care organizations, and through clinically integrated networks.

State Licensures and Certifications

Healthcare lawyers at Waller have comprehensive experience regarding state licensure and certification issues and represent clients in matters involving Certificate of Need applications, whether for or against.

Data Security and Patient Privacy

We also advise clients on:

• HIPAA patient privacy and security regulations
• Electronic storage and transfer of medical records
• Electronic payment systems
• Security programs under the HITECH Act
• Data breaches
• HIPAA enforcement matters with the Office of Civil Rights

Regulatory Investigations and Audits

Clients rely on Waller attorneys for regulatory investigations, audits and appeals involving:

• Medicare reimbursement, including Zone Program Integrity Contracts (ZPIC), Recovery Audit Contractors (RACs) and Medicare Administrative Contractors (MACs)
• Department of Justice, HHS-OIG and Medicaid Fraud Control Unit investigations and enforcement actions
• Allegations of violations of the False Claims Act (FCA), Anti-Kickback Statute (AKS) and Stark Law