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The Effect of Any Willing Provider and Freedom of Choice Laws on Prescription Drug Expenditures 任何自愿提供者和自由选择法对处方药支出的影响
Pub Date : 2015-03-01 DOI: 10.2139/ssrn.2183279
Jonathan Klick, Joshua D. Wright
Pharmacy benefit managers (PBMs) potentially lower costs associated with prescription drugs through increased bargaining power with manufacturers. PBMs engage in selective contracting with pharmacies which has the potential to reduce retail competition, leading to increased prices. Proponents of "Any Willing Provider (AWP)" and "Freedom of Choice (FOC)" laws limiting this selective contracting claim increased retail competition will lower prescription drug spending. Examining the passage of such laws over the period 1991–2009, we find that AWP laws increase spending on prescription drugs by ~5% beyond any pre-existing trends in spending while FOC laws have no significant effect.
药房福利管理(PBMs)通过提高与制造商的议价能力,有可能降低处方药的相关成本。药品福利管理机构与药店签订选择性合同,这有可能减少零售竞争,导致价格上涨。“任何自愿提供者(AWP)”和“选择自由(FOC)”法律的支持者限制这种选择性合同,声称增加零售竞争将降低处方药支出。考察1991-2009年期间此类法律的通过,我们发现AWP法律使处方药支出比任何先前存在的支出趋势增加了约5%,而FOC法律没有显著影响。
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引用次数: 6
First Do No Harm: Protecting Patients Through Immunizing Health Care Workers 首先不伤害:通过卫生保健工作者免疫保护患者
Pub Date : 2015-02-08 DOI: 10.2139/SSRN.2562091
Rene Najera, Dorit R. Reiss
To protect vulnerable patients, hospitals increasingly adopt policies requiring health care workers to be vaccinated against influenza. More than twenty states have also enacted statutes or regulations on the topic. A small minority of health care workers oppose the requirement, and several have appealed to our courts of justice. This article examines the legal issues surrounding influenza mandates for health care workers, including the constitutional framework, federal employment discrimination statutes, and the effect of collective bargaining. It argues that requiring vaccination for health care workers is both ethical and appropriate. While better done via state statute, hospitals have the authority to require vaccination from their workers -- and are not, arguably, required to exempt any workers that do not have medical barriers to vaccination.
为了保护脆弱的病人,医院越来越多地采取政策,要求卫生保健工作者接种流感疫苗。20多个州也颁布了有关该主题的法规或条例。一小部分医疗工作者反对这一要求,其中一些人已经向我们的法院提出上诉。本文探讨了有关卫生保健工作者的流感授权的法律问题,包括宪法框架、联邦就业歧视法规和集体谈判的影响。它认为,要求卫生保健工作者接种疫苗是合乎道德和适当的。虽然最好通过州法规来完成,但医院有权要求其员工接种疫苗,而且可以说,没有必要免除任何没有医疗障碍的工人接种疫苗。
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引用次数: 8
Aging Populations and Physician Aid in Dying: The Evolution of State Government Policy 人口老龄化与医生协助死亡:州政府政策的演变
Pub Date : 2014-11-24 DOI: 10.18060/18390
D. Orentlicher
As state governments respond to the needs of their aging populations, an issue of particular concern is health care at the end of life. With the many advances in public health and medical treatment — as well as in education, wealth, and other socioeconomic metrics — Americans are living much longer lives. But many Americans also face prolonged illness at the end of life that can result in great suffering. Often the suffering can be relieved with good palliative care, but for some Americans continued life becomes intolerable.As a result, there has been increased interest in a right for terminally ill individuals to hasten the dying process by taking a lethal dose of prescription medication (i.e., by “physician aid in dying,” commonly described as “physician-assisted suicide”). The existence of such a right has been litigated in the U. S. Supreme Court and state supreme courts, debated in state legislatures, and addressed in ballot proposals at the state level. Voters in Oregon and Washington have legalized aid in dying by public referendum, legislators in Vermont have done so by statutory enactment, and justices in Montana and a trial court in New Mexico have done so by court holding.In this Article, I discuss the trend toward legalization of physician aid in dying and what it tells us about societal morality regarding medical decisions at the end of life — while legal recognition of a right to aid in dying is growing, its greater recognition does not reflect a change in societal views about the propriety of physician-assisted suicide. We are not seeing an evolution in ethical thought. Rather, society is refining its legal rules for end-of-life law so they better reflect the public’s long-standing moral views about death-hastening choices at the end of life.
随着各州政府对老龄人口的需求作出反应,一个特别令人关注的问题是生命末期的保健。随着公共卫生和医疗的进步,以及教育、财富和其他社会经济指标的进步,美国人的寿命更长了。但许多美国人在生命的最后时刻也面临着长期的疾病,这可能会导致巨大的痛苦。通常,通过良好的姑息治疗,这种痛苦可以得到缓解,但对一些美国人来说,继续生活变得无法忍受。因此,人们越来越关注身患绝症的人是否有权通过服用致命剂量的处方药(即“医生协助死亡”,通常被描述为“医生协助自杀”)来加速死亡过程。这种权利的存在已经在美国最高法院和州最高法院提起诉讼,在州立法机关进行辩论,并在州一级的投票提案中得到解决。俄勒冈州和华盛顿州的选民已经通过全民公决将协助死亡合法化,佛蒙特州的立法者已经通过制定法律来实现这一目标,蒙大拿州的法官和新墨西哥州的一个初审法院已经通过法院裁决实现了这一目标。在这篇文章中,我讨论了医生协助死亡合法化的趋势,以及它告诉我们的关于生命结束时医疗决定的社会道德——虽然法律承认帮助死亡的权利正在增长,但它的更大认可并没有反映出社会对医生协助自杀的适当性的看法的变化。我们没有看到伦理思想的进化。相反,社会正在完善其生命终结法的法律规则,以便更好地反映公众长期以来对生命终结时加速死亡选择的道德观点。
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引用次数: 1
Does Medical Malpractice Law Improve Health Care Quality? 医疗事故法提高了医疗质量吗?
Pub Date : 2014-01-01 DOI: 10.2139/ssrn.2374599
Michael D. Frakes, A. Jena
We assess the potential for medical liability forces to deter medical errors and improve health care treatment quality, identifying liability's influence by drawing on variations in the manner by which states formulate the negligence standard facing physicians. Using hospital discharge records from the National Hospital Discharge Survey and clinically-validated quality metrics inspired by the Agency for Health Care Research and Quality, we find evidence suggesting that treatment quality may improve upon reforms that expect physicians to adhere to higher quality clinical standards. We do not find evidence, however, suggesting that treatment quality may deteriorate following reforms to liability standards that arguably condone the delivery of lower quality care. Similarly, we do not find evidence of deterioration in health care quality following remedy-focused liability reforms such as caps on non-economic damages awards.
我们评估了医疗责任力量在阻止医疗差错和提高医疗保健治疗质量方面的潜力,通过借鉴各州制定医生面临的过失标准的不同方式来确定责任的影响。利用来自全国医院出院调查的出院记录和由医疗保健研究和质量机构启发的临床验证的质量指标,我们发现证据表明,期望医生坚持更高质量的临床标准的改革可能会提高治疗质量。然而,我们没有发现证据表明,在责任标准改革后,治疗质量可能会恶化,而责任标准改革可能会纵容提供低质量的护理。同样,我们没有发现在以补救为重点的责任改革(如非经济损害赔偿上限)之后医疗保健质量恶化的证据。
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引用次数: 43
Removing Financial Barriers to Organ and Bone Marrow Donation: The Effect of Leave and Tax Legislation in the U.S. - Online Appendix 消除器官和骨髓捐赠的经济障碍:美国休假和税收立法的影响-在线附录
Pub Date : 2013-10-08 DOI: 10.2139/SSRN.2337645
N. Lacetera, Mario Macis, Sarah S. Stith
This is an online appendix to Lacetera, N., Macis, M., and Stith, S., 2013: “Removing Financial Barriers to Organ and Bone Marrow Donation: The Effect of Leave and Tax Legislation in the U.S.“ Journal of Health Economics, Forthcoming.The paper "Removing Financial Barriers to Organ and Bone Marrow Donation: The Effect of Leave and Tax Legislation in the U.S" to which these Appendices apply is available at the following URL: http://ssrn.com/abstract=2157956
这是Lacetera, N., Macis, M.和Stith, S., 2013:“消除器官和骨髓捐赠的财务障碍:美国休假和税收立法的影响”的在线附录,即将出版的《卫生经济学杂志》。《消除器官和骨髓捐赠的经济障碍:美国休假和税收立法的影响》这篇论文的附录适用于以下网址:http://ssrn.com/abstract=2157956
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引用次数: 8
The Legal Regulation of Biobanks - National Report: Lithuania 生物银行的法律监管-国家报告:立陶宛
Pub Date : 2013-07-19 DOI: 10.2139/SSRN.2295956
J. Sandor, E. Demény, Petra Bárd
Authors describe and analyze the protection of genetic data in the field of biomedical research and the forensic use of genetic data in Lithuania.
作者描述和分析了立陶宛生物医学研究领域对遗传数据的保护和遗传数据的法医使用。
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引用次数: 2
Waivers and Negligence: Defining the Patient-Physician Relationship by Refusal of Blood Transfusions 免责与过失:以拒绝输血界定医患关系
Pub Date : 2013-04-13 DOI: 10.2139/ssrn.2314076
P. Ciechanowski
This paper discusses a recent health law issue originating from British Columbia, Canada. In Hobbs v. Robertson, the health law issue in question is whether a waiver that bars physician liability for negligence is valid. This is an important question because any answer will have a significant effect on both health law and the patient-physician relationship dynamic. At present, there is no judgment on this case and the British Columbia Court of Appeals has, for the second time, remitted that action back to trial court. This inquiry addresses aspects of tort and contract law in the patient-physician relationship. To address this health law issue, three critical questions are analyzed. The first question is if a waiver can be valid between a patient and physician. The second is whether a waiver is valid only between a patient and a hospital or also with the physician. The final question asks if negligence may be included in a waiver. After analysis, three potential solutions are suggested and discussed with one being chosen as the most suitable for implementing.
本文讨论了最近发生在加拿大不列颠哥伦比亚省的一个卫生法问题。在霍布斯诉罗伯逊案中,卫生法的问题是禁止医生对过失承担责任的弃权是否有效。这是一个重要的问题,因为任何答案都将对卫生法和医患关系产生重大影响。目前,对此案尚未作出判决,不列颠哥伦比亚省上诉法院已第二次将该诉讼退回初审法院。本调查涉及的侵权行为和合同法方面的医患关系。为了解决这一卫生法问题,本文分析了三个关键问题。第一个问题是病人和医生之间的弃权是否有效。第二个问题是弃权是否仅在病人和医院之间有效,还是对医生也有效。最后一个问题是,过失是否可以包括在弃权书中。经过分析,提出并讨论了三种可能的解决方案,并选择了一种最适合实施的解决方案。
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引用次数: 0
Unique Proposals for Limiting Legal Liability and Encouraging Adherence to Ventilator Allocation Guidelines in an Influenza Pandemic 在流感大流行中限制法律责任和鼓励遵守呼吸机分配指南的独特建议
Pub Date : 2013-01-01 DOI: 10.2139/ssrn.2174511
V. Koch, Beth E. Roxland
In a severe influenza pandemic, many more patients would require the use of mechanical ventilators than can be accommodated with current supplies. In order to proactively confront the rationing of resources in preparation for the possibility of severe ventilator scarcity, in 2007, the New York State Task Force on Life and the Law and the New York State Department of Health released a draft guidance document entitled Allocation of Ventilators in an Influenza Pandemic, laying out a comprehensive clinical and ethical framework to guide distribution of ventilators in the event of a severe public health emergency using objective medical criteria, with the ultimate goal of saving the most lives. However, adhering to the Guidelines – despite the significant public health goals contained therein – may expose health care providers and entities to considerable costs and burdens, including the risk of jail time and/or financial penalties, the time and costs of discovery and preparing a case, higher medical malpractice insurance rates, and damage to one’s reputation, unless proper and adequate legal protections are in place. This article addresses the issue of liability for health care workers and entities who adhere to the recommended clinical protocol contained in the Ventilator Guidelines while rendering care in a disaster emergency. We consider the “trigger” for implementing emergency plans – a declaration of a public health or disaster emergency, explore current federal and State law that might offer immunity, defense, or indemnification to certain individuals or entities who provide care in response to that declaration, and offer several unique alternative approaches to mitigate clinicians’ and other entities’ burdens in the event of a lawsuit. The article culminates in recommendations for legislation granting adequate civil and criminal liability protections to health care workers and entities who adhere to the State’s Ventilator Guidelines in a pandemic.
在严重的流感大流行中,需要使用机械呼吸机的患者将远远超过现有供应所能容纳的数量。为了积极应对资源配给问题,为可能出现的呼吸机严重短缺做准备,纽约州生命与法律问题工作队和纽约州卫生部于2007年发布了一份题为“流感大流行中呼吸机的分配”的指导文件草案。制定全面的临床和伦理框架,指导在发生严重公共卫生紧急情况时使用客观的医疗标准分发呼吸机,最终目标是挽救最多的生命。然而,遵守《准则》——尽管其中载有重要的公共卫生目标——可能会使卫生保健提供者和实体承担相当大的成本和负担,包括监禁和(或)经济处罚的风险、发现和准备案件的时间和费用、更高的医疗事故保险费率以及个人声誉受损,除非有适当和充分的法律保护。本文讨论了在灾难紧急情况下提供护理时遵守《呼吸机指南》中所包含的推荐临床方案的卫生保健工作者和实体的责任问题。我们考虑了实施应急计划的“触发因素”——宣布公共卫生或灾难紧急状态,探讨了现行的联邦和州法律,这些法律可能会为响应该声明提供护理的某些个人或实体提供豁免权、辩护或赔偿,并提供了几种独特的替代方法,以减轻临床医生和其他实体在诉讼情况下的负担。文章最后提出了立法建议,为在大流行期间遵守国家呼吸机指南的卫生保健工作者和实体提供充分的民事和刑事责任保护。
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引用次数: 8
Synthetic Biology: Does Re-Writing Nature Require Re-Writing Regulation? 合成生物学:改写自然需要改写规则吗?
Pub Date : 2012-10-01 DOI: 10.2139/SSRN.1975054
J. Paradise, E. Fitzpatrick
Technological advancements in the life sciences are continually pressing forward despite frequent and vocal resistance. Examples of such advancements include reproductive technologies, genetics, stem cell research, nanotechnology, and now synthetic biology. In May 2010, the J. Craig Venter Institute, a multidisciplinary scientific organization led by one of the first scientists to sequence the human genome, announced in the journal Science the creation of the first synthetic cell — a man-made, single-celled organism with the ability to self-replicate. While hailed as a monumental step forward for science, the response from opponents was swift: stop the science from going forward, keep the products off the market, and protect society from the inherent and unknown risks. Recognizing that there are measurable and important differences among advancements in the life sciences in terms of the touchstone risk-benefit dichotomy, this article will examine some promising synthetic biology developments in the medical realm in order to assess the application and performance of the Food and Drug Administration (FDA) regulatory framework. It concludes that the FDA is well equipped to assess and implement protections for products that fit into the traditional clinical trial, review and approval, and post-market regime. However, unlike other developments in the life sciences, synthetic biology poses potential environmental problems not previously contemplated by the limited life-cycle inquiry undertaken by the FDA, suggesting that it may be necessary to reassess the regulation of medical products using synthetic biology techniques.
生命科学领域的技术进步在不断向前推进,尽管有频繁的反对声。这些进步的例子包括生殖技术、遗传学、干细胞研究、纳米技术以及现在的合成生物学。2010年5月,由首批完成人类基因组测序的科学家之一领导的多学科科学组织克雷格文特尔研究所(J. Craig Venter Institute)在《科学》(Science)杂志上宣布,他们创造了第一个合成细胞——一种具有自我复制能力的人造单细胞生物。尽管被誉为科学向前迈出的巨大一步,但反对者的反应很快:阻止科学向前发展,阻止产品进入市场,保护社会免受固有和未知风险的影响。认识到生命科学的进步在风险-收益二分法方面存在可衡量的重要差异,本文将研究医学领域中一些有前途的合成生物学发展,以评估食品和药物管理局(FDA)监管框架的应用和性能。它的结论是,FDA有能力评估和实施符合传统临床试验、审查和批准以及上市后制度的产品保护。然而,与生命科学的其他发展不同,合成生物学带来了潜在的环境问题,而FDA之前进行的有限生命周期调查并未考虑到这一点,这表明可能有必要重新评估使用合成生物学技术的医疗产品的监管。
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引用次数: 8
Legislating Respect: A Pro-Choice Feminist Analysis of Embryo Research Restrictions in Canada 立法尊重:加拿大胚胎研究限制的支持选择女权主义分析
Pub Date : 2012-08-04 DOI: 10.7202/1013389AR
Maneesha Deckha
This article investigates the impact of legislating respect and dignity for the embryo in vitro on the legal and cultural status of the embryo in utero. It evaluates the restrictions on embryo research in Canada’s Assisted Human Reproduction Act (AHRA) to consider whether they should receive pro-choice feminist support. Specifically, the article explores whether it is possible for feminists to accord respect to the in vitro embryo, as the AHRA attempts to do, without jeopardizing support for abortion. The article canvasses the theoretical possibilities of this position by comparing the compatibility of feminist articulations of a right to abortion (bodily integrity and equality) with feminist arguments against the expansive use of embryos in research (commodification and exploitation). The article argues that it is logically compatible for feminists to promote “respect” and “dignity” for in vitro embryos while maintaining a pro-choice position on abortion. The article nevertheless cautions against feminist support for AHRA as it currently stands given that, on a practical basis, a feminist understanding of the AHRA’s restricted embryo research regime is difficult to achieve in the public sphere. The article explains why the more likely result for the public sphere will be an unqualified discourse of respect and dignity for embryos in general, which could then problematically revive the abortion debate and destabilize the non-personhood status of the in utero embryo. As a remedy, the article provides recommendations for how AHRA should be amended so as to better ensure that legislative restrictions on embryo research signal a legislative intent that respects women’s reproductive autonomy.
本文探讨了立法上对体外胚胎的尊重和尊严对体外胚胎的法律和文化地位的影响。它评估了加拿大《辅助人类生殖法》(AHRA)中对胚胎研究的限制,以考虑它们是否应该得到支持堕胎的女权主义者的支持。具体来说,这篇文章探讨了女权主义者是否有可能尊重体外胚胎,就像AHRA试图做的那样,而不损害对堕胎的支持。这篇文章通过比较女权主义者对堕胎权(身体完整和平等)的阐述与女权主义者反对在研究中广泛使用胚胎(商品化和剥削)的论点的兼容性,详细分析了这一立场的理论可能性。文章认为,女权主义者提倡对体外胚胎的“尊重”和“尊严”,同时在堕胎问题上保持支持选择的立场,这在逻辑上是可以兼容的。然而,这篇文章对女权主义者对AHRA的支持提出了警告,因为在实践的基础上,女权主义者对AHRA受限制的胚胎研究制度的理解很难在公共领域实现。这篇文章解释了为什么公共领域更可能的结果是对胚胎的尊重和尊严的毫无保留的论述,这可能会引发堕胎辩论的问题,并破坏子宫内胚胎的非人格地位。作为补救措施,本文就如何修改《人类健康法》提出了建议,以便更好地确保对胚胎研究的立法限制表明尊重妇女生殖自主权的立法意图。
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引用次数: 7
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Medical-Legal Studies eJournal
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