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解读《阳光法案》:医疗保健领域的透明度监管与财务冲突

Deciphering the Sunshine Act: Transparency Regulation and Financial Conflicts in Health Care.

作者信息

Saver Richard S

机构信息

Arch T. Allen Distinguished Professor, UNC School of Law; Professor (Secondary Appointment), UNC School of Medicine; Adjunct Professor, UNC Gillings School of Global Public Health. This article benefited from helpful comments received by participants at the UNC School of Law Faculty Workshop and a conference at Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. Special thanks also to MacKenzie Dickerman and Kerry Dutra for excellent research assistance.

出版信息

Am J Law Med. 2017 Nov;43(4):303-343. doi: 10.1177/0098858817753403.

Abstract

The Physician Payments Sunshine Act ("Sunshine Act"), enacted to address financial conflicts in health care, is the first comprehensive federal legislation mandating public reporting of payments between drug companies, device manufacturers, and medicine. This article analyzes the Sunshine Act's uneven record, exploring how the law serves as an intriguing example of the uncertain case for transparency regulation in health care. The Sunshine Act's bumpy rollout demonstrates that commanding transparency through legislation can be arduous because of considerable implementation challenges. Capturing all the relevant information about financial relationships and reporting it with sufficient contextual and comparative data has proven disappointingly difficult. In addition, the law suffers from uncertainty and poor design as to the intended audience. Indeed, there is strong reason to believe that it will not significantly impact decision-making of primary recipients like patients. Yet the Sunshine Act nonetheless retains important and perhaps underappreciated value. From the almost four years of information generated, we have learned that industry-medicine financial ties vary significantly by physician specialty, and somewhat by physician gender. In many medical fields the distribution of top dollar payments tends to be heavily skewed to a few recipients, all of which have important implications for optimal management of financial conflicts and for health policy more generally. Accordingly, the Sunshine Act's greatest potential is not guiding decisions of individual patients or physicians, but its downstream effects. This Article traces how secondary audiences, such as regulators, watchdogs, and counsel are already starting to make productive use of Sunshine Act information. Public reporting has, for example, made more feasible linking industry payment information with Medicare reimbursement data. As a result, policymakers can more closely examine correlations between industry spending directed at individual physicians and their prescribing and referral decisions. Moreover, savvy counsel are recognizing that Sunshine Act information provides explosive evidence in private civil litigation and this Article explores the first wave of cases.

摘要

《医生薪酬阳光法案》(“阳光法案”)旨在解决医疗保健领域的财务冲突,是首部要求公开报告药品公司、器械制造商与医生之间薪酬情况的综合性联邦立法。本文分析了阳光法案参差不齐的实施记录,探讨了该法律如何成为医疗保健领域透明度监管存在不确定性的一个有趣例证。阳光法案的推出并不顺利,这表明通过立法强制实现透明度可能很艰巨,因为存在诸多实施方面的挑战。事实证明,要获取有关财务关系的所有相关信息并附上足够的背景和比较数据进行报告非常困难。此外,该法律在目标受众方面存在不确定性且设计不佳。确实,有充分理由相信它不会对像患者这样的主要受众的决策产生重大影响。然而,阳光法案仍然具有重要且可能未得到充分重视的价值。从近四年产生的信息中,我们了解到行业与医疗领域的财务关系因医生专业不同而有很大差异,在一定程度上也因医生性别而异。在许多医学领域,高额薪酬的分配往往严重偏向少数接受者,所有这些对于财务冲突的优化管理以及更广泛的卫生政策都具有重要意义。因此,阳光法案的最大潜力并非指导个体患者或医生的决策,而是其下游效应。本文追溯了监管机构、监督机构和律师等二级受众如何已经开始有效利用阳光法案的信息。例如,公开报告使将行业薪酬信息与医疗保险报销数据相联系变得更加可行。结果,政策制定者可以更密切地审查针对个体医生的行业支出与其开处方及转诊决策之间的相关性。此外,精明的律师认识到阳光法案的信息在私人民事诉讼中提供了强有力的证据,本文探讨了首批此类案件。

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