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 moving forward. As a bonus at the end of this guide you will find: *Appendix A - Table of U.S. Transparency, Gift Ban Requirements *Appendix B - District of Columbia *Appendix C - Massachusetts *Appendix D - Nevada *Appendix E - Vermont
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| What is the Physician Payments Sunshine Act or "Open Payments"? |
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1 | (1) |
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II Background and Legislative History of the Physician Payments Sunshine Act |
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9 | (7) |
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III Sunshine Act Regulations and Guidance |
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16 | (41) |
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IV Analysis and Implications |
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57 | (30) |
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87 | (1) |
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88 | (8) |
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96 | (3) |
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Appendix A Table of U.S. Transparency, Gift Ban Requirements |
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99 | (2) |
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Appendix B District of Columbia |
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101 | (8) |
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Persons or Entities Licensed to Provide Healthcare in D.C. |
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101 | (1) |
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Reported Marketing Expenses to D.C. Healthcare Professionals and Entities |
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102 | (2) |
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104 | (1) |
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105 | (1) |
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Prohibition on Gifts and Remuneration to Medication Advisory Committee Members |
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106 | (1) |
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Pharmaceutical Detailing Licenses |
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107 | (2) |
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109 | (8) |
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Prohibited Conduct, Items, or Payments |
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110 | (2) |
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112 | (1) |
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Permissible Payments to Healthcare Practitioners |
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112 | (2) |
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114 | (1) |
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Transparency/Reporting Requirements |
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114 | (1) |
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115 | (1) |
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Formulary Committee Members |
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116 | (1) |
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117 | (2) |
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119 | (2) |
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Gift or Payment Prohibitions |
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121 | (1) |
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122 | (1) |
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Disclosure of Permitted and Allowable Payments (Excluding Samples) |
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123 | (1) |
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Disclosure of Samples and Other Items Provided to a Healthcare Provider for Free Distribution |
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124 | |
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 Stark Lawviolations; 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 radio-frequency 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.
