What Is...the Physician Payments Sunshine Act or Open Payments?

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

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.

Daniel Kracov is co-chair of Arnold & Porter, LLP’s FDA and Healthcarepractice. He assists clients, including start-up companies, trade associations,and large manufacturing companies, in negotiating the challenges relating tothe development, approval and marketing of drugs, biologics, and medical devices.

AllisonWeber Shuren is co-chair of Arnold & Porter, LLP’s FDA/Healthcare practicegroup, where she focuses her practice on a variety of regulatory andlegislative healthcare issues involving Medicare coverage, reimbursement andcoding issues; fraud and abuse counseling and investigations including defenseof allegations of False Claims Act, Anti-Kickback, and StarkLawviolations; and implementation and audit of corporate compliance programs andgovernment imposed corporate integrity agreements.

Alan Reider is a Partner in the FDA and Healthcare practice group in Arnold& Porter, LLP’s Washington, DC office, with more than 30 years ofexperience representing national healthcare corporations, pharmaceutical andmedical device companies, as well as institutional providers and individualpractitioners and suppliers.

Paul Rudolf is a partner in Arnold & Porter,LLP’s Washington, DC office. Dr. Rudolf has significant experience in both Medicareand FDA legal, regulatory and policy issues, particularly those relating tocounterfeit drugs and radiofrequency identification technology as applied topharmaceuticals and medical devices.

Lauren Nicole Miller is an associate in Arnold & Porter LLP's FDA andHealthcare practice group, where she provides counseling on regulatory andpublic policy issues for clients in the drug, food, medical device, andhealthcare sectors.