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What Is...The Physician Payments Sunshine Act or "Open Payments"?
By Abraham Gitterman, Daniel Kracov, Allison Shuren and
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This guide provides a detailed overview of the Sunshine Act, transparency initiatives, and related implications associated with increased attention on physician-industry relationships. • Section II provides background and the legislative history of the Sunshine Act. • Section III provides a detailed summary and analysis of the technical statutory and regulatory requirements manufacturers and group purchasing organizations must abide by to comply with the law. • Section IV analyzes the Sunshine Act's regulatory requirements as they may impact other healthcare fraud and abuse and compliance obligations and requirements, including the Anti-Kickback Statute and the False Claims Act. • Section IV.C provides an overview of related state transparency laws and gift ban laws, including how such provisions are preempted under the Sunshine Act. • Section V offers a brief overview of CMS's first data release on the Open Payments website and discusses potential issues and future concerns for all stakeholders
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Abraham Gitterman
Abraham Gitterman is an associate in Arnold & Porter's FDA andHealthcare Group in the firm's Washington, DC office, where his practicefocuses on FDA and health-care regulatory matters involving pharmaceuticals,medical devices, medical technology and software, and mobile apps.
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