Life Sciences and Healthcare Regulatory

Hospitals, Health Systems and Clinically Integrated Healthcare Delivery

Operation of a hospital or health system is one of the most complex and regulated business enterprises, whether on a for-profit or nonprofit basis. In addition to the customary concerns associated with a business that must maintain a high census at all times to avoid waste, other issues such as payer mix, length of stay, and billing and collection matters can materially affect the financial success and even viability of hospital services providers. At the same time, success requires the need to maintain an active medical staff while competing with physician-owned ventures and complying with the Anti-Kickback, Stark, and other fraud and abuse laws. Nonprofit tax exempt hospitals face additional challenges arising out of the need to provide charity care and avoid private inurement issues and management must report to boards of directors or trustees that may include members who do not have an in-depth understanding of the hospital business.

Our work includes: healthcare transactions, physician-contracting, creation of new delivery models, including some of the first accountable care organizations, physician-led clinically integrated networks, creation of new specialty independent physician associations, and new models involving private equity partners. We are a recognized leader in the field of healthcare compliance services. We have designed, helped implement, and provided ongoing advice with respect to hundreds of compliance programs. We have performed in-depth and confidential compliance audits to help strengthen existing compliance programs and assure that they meet the "effectiveness" standard necessary to provide protection in a situation involving a government inquiry.

Our attorneys have successfully defended and advised some of the most substantial healthcare providers in the nation with respect to investigations and proposed enforcement actions pertaining to the False Claims Act, the Anti-Kickback law, the Stark law, and other federal and state fraud and abuse laws by the OIG, the Department of Justice, Offices of the United States Attorneys, and state enforcement agencies. To the extent practical, we attempt to resolve these issues informally with the applicable agencies; however, we are experienced in defending our physician and hospital/healthcare system clients in court or through administrative proceedings. In addition, our attorneys have negotiated and provided advice to our healthcare clients relating to numerous Corporate Integrity Agreements and Individual Integrity Agreements.


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