Hospitals, surgery centers, imaging centers, skilled nursing facilities, behavioral care providers, senior living facilities, hospices and home health agencies, renal care providers, urgent care centers, healthcare suppliers and many others turn to Waller every day for assistance with navigating the federal and state regulations that impact both their day-to-day operations and their long-term objectives. Our goal is to provide peace of mind as we guide them through a virtual regulatory minefield. Their confidence is based on our 40+ years of experience with healthcare regulatory law and the fact that many of the solutions to complex problems we have developed are now models used throughout the healthcare industry.

Whether it's day-to-day operational issues or transactional matters, our healthcare regulatory compliance attorneys work closely with our clients to understand their strategic objectives and then develop creative approaches to achieve those goals. The depth and breadth of our regulatory experience is central to our mission. Clients rely on Waller for assistance with Medicare enrollment and reimbursement,  Stark, state and federal anti-kickback compliance, along with the Emergency Medical Treatment and Active Labor Act, Joint Commission standards, patient privacy rules and myriad other regulations.

We work to develop innovative models for hospitals and physicians to work together, e.g., through clinical co-management agreements and foundation models, within Physician-Hospital Organizations and Accountable Care Organizations and through joint venture arrangements. In each approach, our objective is to minimize the regulatory risk faced by our clients as they achieve their strategic goals. Our regulatory compliance attorneys work in concert with the firm's transactional attorneys to structure mergers, acquisitions and joint ventures to ensure compliance with federal and state regulations.

We are frequently called upon to assist clients with regulatory investigations, audits and appeals involving Medicare reimbursement, including Zone Program Integrity Contracts (ZPIC), Recovery Audit Contractors (RACs) and Medicare Administrative Contractors (MACs). In addition, we assist clients with state survey and certification issues, and we also have extensive experience preparing and filing Certificate of Need applications where they are required for the establishment of new healthcare services and facilities.

Waller provides guidance with respect to patient information technology, and we advise clients on day-to-day operational issues and compliance issues related to HIPAA patient privacy/security regulations, the electronic storage and transfer of medical records and electronic payment systems. We assist clients in developing internal policies and procedures for health information and provide counsel on new and existing agreements with business associates that are now required to implement security programs under the HITECH Act. Additionally, we advise clients on how to respond to security breaches.

Finally, Waller has successfully represented and defended companies and individuals in the healthcare industry in a wide range of government investigations and proceedings. We represent companies, boards of directors and individual executives in federal, state and local regulatory matters throughout the country. We help clients respond to and survive government investigations with strategies that minimize – or avoid completely – sanctions, negative publicity and disruptions to core business operations.

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