Journal of health care law & policy最新文献

{"title":"When Not to Ask: A Defense of Choice-Masking Nudges in Medical Research.","authors":"Susanna McGrew,&nbsp;Sarah Raskoff,&nbsp;Benjamin E Berkman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>In this article, we examine the legality and ethics of a controversial but widespread practice in clinical research: choice-masking nudges. A choice-masking nudge (CMN) exists when a research team explicitly obscures a meaningful choice from participants by presenting a default decision as the standard way forward. Even though an easy-to-use opt-out mechanism is available for participants who independently express concerns with the standard default, the fact that a default has been pre-selected is not made obvious to research participants. To opt out of the nudge, a participant must overtly request non-standard treatment. We argue that use of such nudges in medical research can be justified by their individual, collective, and social benefits, provided that they respect autonomy and satisfy our four further acceptability conditions. The structure of this Article is as follows. In Part II, we describe three controversial cases of CMNs in medical research. In Part III, we provide background on nudging and explain how our proposed CMNs fit into the existing literature on nudging and libertarian paternalism. In Part IV, we explain how the reasonable person standard as employed by United States research regulations can be used to support CMNs. In Part IV, we anticipate some of the strongest objections to CMNs by explaining how CMNs are compatible with a wide range of plausible accounts of autonomy. Finally, in Part VI, we discuss four additional core considerations an acceptable CMN must meet: legitimate policy goals; benefits outweighing harms; burdens distributed fairly; and absence of ethically superior feasible alternatives. We also analyze the three existing controversies explored in Part II and show how each would benefit from the conceptual clarity offered by our analytic framework. Medical research is complicated and can be difficult for participants to understand; thoughtfully designed CMNs can play an important role in gently guiding large numbers of research participants toward decision outcomes that really are best for them and their communities.</p>","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10078241/pdf/nihms-1885893.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9627495","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FAIR BENEFITS AND ITS CRITICS: WHO IS RIGHT?","authors":"David Wendler, Seema K Shah","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10569338/pdf/nihms-1885492.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41222247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"REFUTING THE RIGHT NOT TO KNOW.","authors":"Benjamin E Berkman","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>While promising to eventually revolutionize medicine, the capacity to cheaply and quickly generate an individual's entire genome has not been without controversy. Producing information on this scale seems to violate some of the accepted norms governing the practice of medicine, norms that evolved during the early years of genetic testing when a targeted paradigm dominated. One of these widely accepted norms was that an individual had a right not to know genetic information about him or herself. Prompted by evolving professional practice guidelines, the right not to know has become a highly controversial topic. The medical community and bioethicists are actively engaged in a contentious debate about the extent to which individual choice should play a role (if at all) in determining which clinically significant findings are returned. This paper explores the extent to which it is legally and ethically necessary to respect the so-called right not to know genetic information about oneself. Challenging the majority view that the right not to know is sacrosanct, I push back against that vigorously held (although not always rigorously defended) position, in defense of the idea that we should abandon the notion of a strong right not to know. Drawing on the fields of law, philosophy and social science, I provide an extended argument in support of a default for returning high value genetic information without asking about a preference not to know. I conclude by offering some recommendations about how best to balance individual autonomy and professional beneficence as the field of genomic medicine continues to evolve.</p>","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10078625/pdf/nihms-1885904.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9641625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"DO ETHICS DEMAND EVALUATION OF PUBLIC HEALTH LAWS? SHIFTING SCIENTIFIC SANDS AND THE CASE OF YOUTH SPORTS-RELATED TRAUMATIC BRAIN INJURY LAWS.","authors":"Kerri McGowan Lowrey, Stephanie R Morain, Christine M Baugh","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2016-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5241084/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89720979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fragmentation in Mental Health Benefits and Services: A Preliminary Examination into Consumption and Outcomes","authors":"Barak D Richman, F. Sloan, Daniel S. Grossman","doi":"10.2139/ssrn.1460935","DOIUrl":"https://doi.org/10.2139/ssrn.1460935","url":null,"abstract":"In this chapter, we examine consumption patterns and health outcomes within a health insurance system in which mental health benefits are administered under a carved-out insurance plan. Using a comprehensive dataset of health claims, including insurance claims for both mental and physical health services, we examine both heterogeneity of consumption and variation in outcomes. Consumption variation addresses the regularly overlooked question of how equal insurance and access does not translate into equitable consumption. Outcomes variation yields insights into the potential harms of disparate consumption and of uncoordinated care. We find that even when insurance and access are held constant, consumption of mental health services varies dramatically across race and class. We are unable, however, to find any evidence that higher levels of consumption correspond with improved health when health status is controlled. We also find some evidence of the costs of fragmentation, such as uncoordinated care, low adherence rates, and variation in sources of care. These findings have important implications for both the delivery of health services and the administration of health insurance benefits.","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2012-08-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88419332","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"QALYs and Policy Evaluation: A New Perspective","authors":"M. Adler","doi":"10.2139/ssrn.655865","DOIUrl":"https://doi.org/10.2139/ssrn.655865","url":null,"abstract":"This Article presents a new, welfarist defense of the use of QALYs (quality adjusted life years) in policy evaluation. It challenges both the conventional wisdom among health economists that QALY-based analysis is dominated by traditional cost-benefit analysis (i.e., the sum of willingness-to-pay amounts) as well as the standard view of public health researchers that QALYs should function as the effectiveness metric in a cost-effectiveness analysis. Instead, the Article defends a nontraditional form of cost-benefit analysis, where QALYs are multipled by a conversion factor, for example $100,000 per QALY, and added to the monetized non-health effects of a policy. Part I of the Article surveys the current literature on QALYs. Part II shows that QALYs can be a more accurate measure of overall well-being than WTP amounts, under certain conditions, and argues that cognitive difficulties interfering with the measurement of WTP amounts can be circumvented by QALYs. Part III describes the limitations of QALYs. Part IV discusses the role that QALYs should play in welfarist policy analysis, given their strengths and limitations. In particular, it presents a pragmatic approach to determining the QALY-to-dollar conversion factor, and sheds new light on the controversy about pricing whole lives versus life-years.","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2010-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87379356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Impact of Tort Reform on Employer-Sponsored Health Insurance Premiums","authors":"R. Avraham, Leemore S. Dafny, Max M. Schanzenbach","doi":"10.2139/ssrn.1441903","DOIUrl":"https://doi.org/10.2139/ssrn.1441903","url":null,"abstract":"We evaluate the effect of tort reform on employer-sponsored health insurance premiums by exploiting state-level variation in the timing of reforms. Using a dataset of healthplans representing over 10 million Americans annually between 1998 and 2006, we find that caps on non-economic damages, collateral source reform, and joint and several liability reform reduce premiums by 1 to 2 percent each. These reductions are concentrated in PPOs rather than HMOs, suggesting that can HMOs can reduce \"defensive\" healthcare costs even absent tort reform. The results are the first direct evidence that tort reform reduces healthcare costs in aggregate; prior research has focused on particular medical conditions.","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2009-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87937873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Stark Contrasts: The Impact of Prohibiting Physician Self-Referrals on the Prevalence of Overtreatment in Health Care","authors":"Brian K Chen","doi":"10.2139/ssrn.1409936","DOIUrl":"https://doi.org/10.2139/ssrn.1409936","url":null,"abstract":"Do physicians invest in medical service facilities to profit from the overtreatment of patients? Current literature only shows that physicians with a financial interest in an entity to which they refer patients order more services than physicians without such a financial interest. These studies, however, do not prove that the additional services constitute “overtreatment.” Using medical claims data from Taiwan, I examine the impact of a policy designed to remove physicians’ financial incentives to overprescribe drugs by prohibiting clinic-pharmacy integration, and make three principal findings: (1) Physicians in clinics that are vertically integrated with a pharmacy overtreat patients with prescription drugs. (2) Removing the incentives to overprescribe drugs causes physicians to overprescribe diagnostic and laboratory tests instead (3) This overtreatment occurs even when physicians refer patients to an employee-pharmacist in the clinic rather than to an outside entity in which physicians have a financial interest. These findings have important implications for federal Stark Legislation (42 U.S.C.S. §1395nn), which prohibits physicians’ referral of Medicare/Medicaid patients to an entity in which they have a “financial relationship” for certain designated health services. In particular, the third finding calls into question Stark Law’s implicit assumption that vertically integrated medical providers are unlikely to overtreat patients, as exemplified by the “bona fide employee” safe harbor exception.","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2009-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89507864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"An Analysis of the General Consumer Interest as a Source of Regulatory Legitimacy in the Case of the Dutch Healthcare Authority","authors":"W. Sauter","doi":"10.2139/ssrn.1409625","DOIUrl":"https://doi.org/10.2139/ssrn.1409625","url":null,"abstract":"Economic regulation by independent regulatory authorities is justified in a legal sense by theories based on delegation, (partial) ministerial responsibility and judicial review, or more recently on regulatory contracts and stakeholder representation. While none of these models is fully satisfactory they all focus either on the relationship between the regulator and the central authority, or on that with the parties that are the subject of economic regulation, and do not focus upon the ultimate objective of economic regulation itself: consumer benefits. The Dutch Healthcare Market Regulation Act (Wmg) creates a new starting point because it not only introduces the general consumer interest as a legal concept but as the priority objective of regulation - albeit based on a motivation that is largely implicit. This paper provides an initial investigation on how to interpret this concept, operationalised in the three variables quality, affordability and accessibility. It draws inter alia on the economic approach to regulation (based on the concepts of market failure and market power, and more recent notions of bounded rationality), and whether it can provide a non-trivial source of legitimacy based on the results achieved in serving the statutory constituency of the regulator: the consumer.","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2009-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85799279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Property, Privacy and the Pursuit of Integrated Electronic Medical Records","authors":"M. Hall","doi":"10.2139/SSRN.1334963","DOIUrl":"https://doi.org/10.2139/SSRN.1334963","url":null,"abstract":"Who owns a patient's medical information? The patient, the provider, or the insurer? All of the above? None of the above? In the emerging era of electronic medical records, no other legal question is more critical, more contested, or more poorly understood. Ownership was never much in doubt in an age of paper-based records, but now that information content can be easily digitized and freed from any particular storage medium, confusion reigns. How this issue is resolved can have huge impacts on how or whether massive anticipated developments in electronic and personal health records will take shape. The respective property rights of patients, providers and insurers will strongly influence, if not determine, what form of electronic health informatics ends up predominating. And, whether rights to access and use medical information can be commercialized may determine whether effective, comprehensive medical information networks can emerge at all, absent overt government mandate. This paper analyzes optimal property rights in medical information from the perspective of network economics. It proposes that patients be allowed to monetize their access and control rights by assigning them to a trusted intermediary who may then place these rights in a stream of commerce that determines their value and best use. The funds generated can then be distributed both to patients and providers to encourage their adoption and use of interconnected electronic records.","PeriodicalId":73765,"journal":{"name":"Journal of health care law & policy","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2009-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90392119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}