In Pacificare Health Systems, Inc. v. Jefrey Book, the US. Supreme Court ruled that the mandatory arbitration clause in an HMO contract should be enforced to compel a physician to arbitrate his RICO charges against the health plan, even though the clause could be construed to limit the arbitrator’s authority to award full damages under the RICO statute. The ruling could prevent physicians with health plan arbitration agreements from taking future reimbursement claims against insurance companies directly to court, even (...) when the allegations involve a potential statutory breach outside of the explicit scope of the provider contract.Dr. Book’s arbitration claim was part of a larger class action lawsuit filed in August of 2000 by a group of physicians and patients seeking reimbursement from eight managed care companies for unpaid health insurance claims. (shrink)

In Pacificare Health Systems, Inc. v. Jefrey Book, the US. Supreme Court ruled that the mandatory arbitration clause in an HMO contract should be enforced to compel a physician to arbitrate his RICO charges against the health plan, even though the clause could be construed to limit the arbitrator’s authority to award full damages under the RICO statute. The ruling could prevent physicians with health plan arbitration agreements from taking future reimbursement claims against insurance companies directly to court, even (...) when the allegations involve a potential statutory breach outside of the explicit scope of the provider contract.Dr. Book’s arbitration claim was part of a larger class action lawsuit filed in August of 2000 by a group of physicians and patients seeking reimbursement from eight managed care companies for unpaid health insurance claims. (shrink)

There are marked differences between countries with regard to reimbursement decision-making, yet few studies have tried to understand this process and its consequences by a detailed analysis of the local context and decision-making structure. This article describes reimbursement decision-making and subsequent prescribing patterns of new pharmaceuticals by means of a case study on glitazones in treatment of type 2 diabetes mellitus patients in Denmark. The study shows that institutional arrangements, providing the context in which evidence is used, are (...) highly important for understanding the reimbursement decision-making process. In particular the Danish Medicines Agency (DMA) has shaped the decision to reimburse glitazones on the basis of physician-mediated requests of individual patients. Relatively few patients have been prescribed glitazones since their introduction in 2000, suggesting that individual reimbursement may be an effective instrument in controlling overall expenditure of selected pharmaceuticals, although in the case of glitazones this has likely been achieved at the expense of equality in access to the products. The discussion focuses on the generalizability of the findings to both other pharmaceuticals in the individual reimbursement scheme in Denmark, and to other countries that are trying to balance the need to control overall pharmaceutical care expenditure with the need to secure equality in access to new drugs with therapeutic added value. (shrink)

When the cost-effectiveness of newly approved cancer treatments is insufficient or unclear, they may not (immediately) be eligible for reimbursement through basic health insurance in publicly funded healthcare systems. Patients may seek access to non-reimbursed treatment through other channels, including individual funding requests made to hospitals, health insurers, or pharmaceutical companies. Alternatively, they may try to pay out of pocket for non-reimbursed treatments. While currently little is known of these practices, they run counter to a deeply held egalitarian ethos (...) that is prevalent in many publicly funded healthcare systems. In this article, we investigate to what extent this ethos can be grounded in theories of justice, notably egalitarianism and prioritarianism. We argue that allowing out-of-pocket payments by patients themselves, in principle, is not unjust from the perspective of either of these theories, provided that it does not raise in-practice justice-based concerns, for instance by displacing more cost-effective care, to the detriment of other patients, or by failing to treat patients equally. In contrast, we conclude that the practice of making exceptions for individual patients by health insurers or healthcare providers does run counter to the justice-based requirements of equal treatment. (shrink)

It has been hypothesised that the reimbursement system pertaining to radiotherapy is influencing prescription practices for patients with cancer with bone metastases. In this paper, we present and discuss the results of an empirical study that was undertaken on patient records, referred to radiotherapy for the treatment of bone metastases, in a medium-size city, in southern Brazil, during the period of March 2006 to March 2014. Our findings seem to confirm this hypothesis: after a change in the reimbursement (...) method, radiation prescriptions were adapted accordingly, in order to maximise profits. Once such patients become highly vulnerable due to their diagnoses, they also become susceptible to a subtle form of exploitation; physicians let patients believe that more radiation will be better for their health, and they do so despite knowing otherwise, and as it seems, out of pecuniary interests. (shrink)

This article investigates the distribution of power in Poland’s drug reimbursement policy in the early 2000s. We examine competing theoretical expectations suggested by neopluralism, historical institutionalism, corporate domination, and clique theory of the post-communist state, using data from a purposive sample of 109 semi-structured interviews and documentary sources. We have four concrete findings. First, we uncovered rapid growth in budgetary spending on expensive drugs for narrow groups of patients. Second, to achieve these favorable policy outcomes drug companies employed two (...) prevalent methods of lobbying: informal persuasion of key members of local cliques and endorsements expressed by patient organizations acting as seemingly independent “third parties.” Third, medical experts were co-opted by multinational drug companies because they relied on these firms for scientific and financial resources that were crucial for their professional success. Finally, there was one-way social mobility from the state to the pharmaceutical sector, not the “revolving door” pattern familiar from advanced capitalist countries, with deleterious consequences for state capacity. Overall, the data best supported a combination of corporate domination and clique theory: drug reimbursement in Poland was dominated by Western multinationals in collaboration with domestically based cliques. (shrink)

ZusammenfassungDie Arzneimittelzulassung und der Aufnahmeprozess zur Kostenerstattung sollen die Entwicklung und Vermarktung von pharmazeutischen Innovationen mit Patientennutzen nicht behindern, zugleich aber die Wirtschaftlichkeit der Arzneimittelversorgung für die Kostenträger nicht gefährden. Eine Anpassung der Verfahren an die Merkmale personalisierter Arzneimittel erscheint notwendig. Dabei ist allerdings zu fragen, ob eine ungerechtfertigte Privilegierung erfolgt. In den USA und in der EU werden die jeweiligen Zulassungsverfahren für Arzneimittel und Tests schrittweise angepasst und integriert. Zulassung und Erstattungsentscheidungen sollen koordiniert werden. Eine Privilegierung, wie bei Arzneimitteln (...) für seltene Indikationen, findet jedoch für personalisierte Medizin nicht statt. Es bestehen keine unzumutbaren Hürden für die Hersteller. Zurückhaltung bei der Entwicklung innovativer Produkte wäre deshalb nicht gerechtfertigt. (shrink)

Clinical next generation sequencing is a term that refers to a variety of technologies that permit rapid sequencing of large numbers of DNA segments, up to and including entire genomes. As an approach that is playing an increasingly important role in obtaining genetic information from patients, it may be viewed by public and private payers either positively, as an enabler of the promised benefits of personalized medicine, or as “the perfect storm” resulting from the confluence of high market demand, an (...) uproven technology, and an unprepared delivery system. A number of recent studies have noted that coverage and reimbursement will be critical for clinical integration of NGS, yet the evidentiary pathway for payer decision-making is unclear. Although there are multiple reasons for this uncertain reimbursement environment, the situation stems in large part from a long-standing lack of alignment between the information needs of regulators and post-regulatory decision-makers such as payers. (shrink)

An ethical issue that has largely been overlooked and neglected is the potential conflict of interests faced by medical professionals in the recruitment, counselling and reimbursement of egg donors. It must be noted that fertility treatment in private practice is an overwhelmingly profit-driven enterprise. To attract more patients and generate more income, there is a strong incentive for fertility clinics and doctors to actively and aggressively recruit women for their egg donation programme. In some countries where substantial financial remuneration (...) for egg donation is permitted—for example, the United States,1 2 fertility doctors and clinical embryologists often act as the “middleman” or broker to facilitate the transaction of eggs between donor and recipient. Very often, the usual practice is for fertility clinics to charge patients a commission for sourcing egg donors, which is an additional profit on top of substantial medical fees that would be earned from provision of fertility treatment to the same patient. This is ethically contentious; because the money earned is not directly related to medical services rendered to the patient, but is instead attributed to the brokerage and transaction of donated human material.There is a risk that the welfare of the …. (shrink)

This paper reviews the main pricing policies in Latin American countries, discussing their shortcomings. It also gives an overview of the most common pricing and reimbursement policies in Europe and describes in detail three well-established approaches — international price referencing, value-based pricing, including setting up of health technology assessment, and generic and biosimilar policies — building on country examples.

Public healthcare systems are increasingly refusing (temporarily) to reimburse newly approved medical treatments of insufficient or uncertain cost-effectiveness. As both patient demand for these treatments and their list prices increase, a market might arise for voluntary additional health insurance (VHI) that covers effective but (very) expensive medical treatments. In this paper, we evaluate such potential future practices of VHI in public healthcare systems from a justice perspective. We find that direct (telic) egalitarian objections to unequal access to expensive treatments based (...) on different ability to afford VHI do not stand up to scrutiny. However, such unequal access might lead to loss of self-respect among individuals, or loss of fraternity within society, rendering it more difficult for citizens to interact on equal moral footing. This would be problematic from a relational egalitarian perspective. Moreover, the introduction of VHI might turn out to have negative consequences for the comprehensiveness and/or the quality of the public healthcare services that are offered to all patients equally through basic health insurance. These consequences must be weighed against potential health gains and the value of liberty. We conclude that governments should be careful when considering the introduction of VHI in public healthcare systems. (shrink)

Controversies still exists within the research fraternity on the form and level of incentives, compensation and reimbursement to study participants in resource-constrained settings. While most research activities contribute significantly to advancement of mankind, little has been considered in rewarding directly the research participants from resource-constrained areas. A study was conducted in Zimbabwe to investigate views and expectations of various stakeholders on study participation incentives, compensation and reimbursement issues. Data was collected using various methods including a survey of about (...) 1,008 parents/guardians of school children participating in various immunological cohort studies and parasitology surveys. Community advisory boards (CABs) at 9 of the sites were also consulted. Further, information was gathered during discussions held at a basic research ethics training workshop. The workshop had 45 participants that including 40 seasoned Zimbabwean researchers and 5 international research collaborators. About 90% (907) of the study participants and guardians expected compensation of reasonable value, in view of the researchers' value and comparison to other sites regardless of economic status of the community. During discussion with researchers at a basic ethics training workshop, about 80% (32) believed that decisions on level of compensation should be determined by the local research ethics committees. While, the few international research collaborators were of the opinion that compensation should be in accordance with local guidelines, and incentives should be in line with funding. Both the CAB members and study participants expressed that there should be a clear distinction between study incentive and compensation accorded to individual and community expectations on benefits from studies. However, CABs expressed that their suggestions on incentives and compensation are often moderated by the regulatory authorities who cite fear of unknown concerns. Overall, both personal and community benefits need to be considered colectively in future studies to be conducted in resource-constrained communities. There is projected fear that recruitment in future may be a challenge, now that almost every community, has somehow been reached and participated in some form of studies. A major concern on reimbursement, compensation or incentives should be internationally pegged regardless of different economic status of the individuals or communities where the study is to be conducted. (shrink)

BackgroundDuring the last decade, the possibility for women to cryopreserve oocytes in anticipation of age-related fertility loss, also referred to as social egg freezing, has become an established practice at fertility clinics around the globe. In Europe, there is extensive variation in the costs for this procedure, with the common denominator that there are almost no funding arrangements or reimbursement policies. This is the first qualitative study that specifically explores viewpoints on the (lack of) reimbursement for women who (...) had considered to uptake at least one social egg freezing cycle in Belgium.MethodsTo understand the moral considerations of these women, drawing from twenty-one interviews, this paper integrates elements of a symbiotic empirical ethics approach and thematic analysis.ResultsWe identify four themes: (1) being confronted with unclear information; (2) financial costs as ongoing concern; (3) necessity of coverage; (4) extent of reimbursement. In the first theme, we found that some women were concerned about the lack of clear information about the cost of social egg freezing. In the second theme, we report moral sentiments of injustice and discrimination which some women attributed to their struggles and needs not being recognised. The third theme illustrates diverse views on reimbursement, ranging from viewing social egg freezing as an elective treatment not appropriate for reimbursement to preferences for greater public responsibility and wider access. Finally, we describe the participants’ varying proposals for partial reimbursement and the idea that it should not be made available for free.ConclusionsThis research adds important empirical insights to the bioethics debate on social egg freezing, in particular by presenting (potential) users’ views on the lack of reimbursement. While there is much more to say about the ethical and political complexities of the reimbursement of this procedure, our study highlighted the voices of (potential) users and showed that at least some of them would welcome the coverage of SEF through the public healthcare insurance. (shrink)

The U.S. Court of Appeals for the District of Columbia upheld, in Presbyterian Medical Center of the University of Pennsylvania Health System v. Shalala, 170 F.3d 1146, a federal district court ruling granting summary judgment to the Department of Health and Human Services in a case in which Presbyterian Medical Center challenged Medicare's requirement of contemporaneous documentation of $828,000 in graduate medical education expenses prior to increasing reimbursement amounts. DHHS Secretary Donna Shalala denied PMC's request for reimbursement for (...) increased GME costs. The appellants then brought suit in federal court challenging the legality of an interpretative rule that requires requested increases in reimbursement to be supported by contemporaneous documentation. PMC also alleged that an error was made in the administrative proceedings to prejudice its claims because Aetna, the hospital's fiscal intermediary, failed to provide the hospital with a written report explaining why it was denied the GME reimbursement. (shrink)

In January 2016, Medicare began reimbursing clinicians for time spent engaging in advance care planning with their patients or patients’ surrogates. Such planning involves discussions of the care an individual would want to receive should he or she one day lose the capacity to make health care decisions or have conversations with a surrogate about, for example, end‐of‐life wishes. Clinicians can be reimbursed for face‐to‐face explanation and discussion of care and advance directives and for the completion of advance care planning (...) forms. Although it seems that political barriers to reimbursement for such planning have largely faded, the Medicare policy's impact on provider billing practices appears to be limited, suggesting other barriers to clinician engagement in advance care planning. Additionally, the effects of this policy on patient behavior and the clinician‐patient relationship are not yet known. (shrink)

Integrity and research ethics are cherished institutions in academic world. Although most societies have rules and codes that govern ethical conducts in research, few studies have provided quantitative evidence on the impacts of these regulations and codes on the behaviors of researchers. In the context of a nationwide anti-corruption campaign in China, this paper evaluates the changes of principal investigators’ reimbursement behavior in a leading university when new reimbursement policies were introduced. Utilizing a novel grant dataset and a (...) regression discontinuity design, we find that the new policies lowered PIs’ monthly average amount of reimbursement from research grants by 35%, which can be interpreted as a reduction in grant misuse. Following speculations we argue that institutionalizing orchestrated efforts on grant management, payroll systems, and research integrity education is in the right direction toward building China into a true scientific power. (shrink)

The proposed framework by Lynch et al. (2021) for promoting ethical forms of payment in Human Infection Controlled Studies (HICS) in general and SARS-Cov-2 HICS in particular is an important contri...

Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their preparticipation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may (...) be permissible to offer differential incentive payments if necessary to advance the goals of a study. We encourage investigators and Institutional Review Boards to think about whether to offer payment, in what amounts and for what purpose, and also to consider whether differential payment can help promote the scientific and ethical goals of clinical research. (shrink)

Recognizing that offers of payment to research participants can serve various purposes—reimbursement, compensation, and incentive—helps uncover differences between participants that can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their pre-participation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may (...) be permissible to offer differential incentive payments if necessary to advance a study’s goals. We encourage investigators and Institutional Review Boards to think not only about whether to offer payment, in what amounts, and for what purpose, but also to consider whether differential payment can help promote the scientific and ethical goals of clinical research. (shrink)

Background When anti-cancer treatments have been given market authorization, but are not (yet) reimbursed within a healthcare system, physicians are confronted with ethical dilemmas. Arranging access through other channels, e.g., hospital budgets or out-of-pocket payments by patients, may benefit patients, but leads to unequal access. Until now, little is known about the perspectives of physicians on access to non-reimbursed treatments. This interview study maps the experiences and moral views of Dutch oncologists and hematologists.Methods A diverse sample of oncologists and hematologists (...) (n = 22) were interviewed. Interviews were analyzed thematically using Nvivo 12 qualitative data software.Results This study reveals stark differences between physicians’ experiences and moral views on access to anti-cancer treatments that are not (yet) reimbursed: some physicians try to arrange other ways of access and some physicians do not. Some physicians inform patients about anti-cancer treatments that are not yet reimbursed, while others wait for reimbursement. Some physicians have principled moral objections to out-of-pocket payment, while others do not.Conclusion Oncologists and hematologists in the Netherlands differ greatly in their perspectives on access to expensive anti-cancer treatments that are not (yet) reimbursed. As a result, they may act differently when confronted with dilemmas in the consultation room. Physicians working in different healthcare systems may face similar dilemmas. (shrink)

Recent major amendments of the Code of Civil Procedure of the Republic of Lithuania have added new and improved older procedural instruments that may be used for reimbursement of losses inflicted by the abuse of process. The law now clearly states that the court may take into account improper conduct of the participants when deciding on distribution of litigation costs. A fine in favour of the party aggrieved by the abuse may also be imposed. Therefore, in this article the (...) authors analyse litigation costs and private fine as measures to reimburse losses caused by the abuse of civil procedure. The authors argue that litigation costs can be a fairly effective and relatively easy-to-use procedural instrument, which might not only prevent procedural abuses, but also compensate losses inflicted by it that falls within the category of litigation costs. Therefore, changes to the statutory legislation, expressly empowering a court to deviate from general rules of distributing and awarding litigation costs, by taking into account the propriety of the party’s actions in a procedure and causes that have given rise to those litigation costs, are welcomed. (shrink)

The current legal framework within the Lithuanian health system is described including a review of the physician’s autonomy, rights and duties, and patients’ rights including the right to reimbursement. The role of ethical codes and the law are discussed.

Restructured health care reimbursement systems and new requirements for nonprofit hospitals are transforming the U.S. health system, creating opportunities for enhanced integration of public health and health care goals. This article explores the role of public health practitioners and lawyers in this moment of transformation. We argue that the population perspective and structural strategies that characterize public health can add value to the health care system but could get lost in translation as changes to tax requirements and payment systems (...) are rapidly implemented. We urge public health leaders to take a more active role in hospital assessments of community health needs and evaluation of the patient outcomes for which providers are accountable. (shrink)

Next SectionClaims for reimbursement of child support, the reversal of property settlements and compensation can arise when misattributed paternity is discovered. The ethical justifications for such claims seem to be related to the financial cost of bringing up children, the absence of choice about taking on these expenses, the hard work involved in child rearing, the emotional attachments that are formed with children, the obligation of women to make truthful claims about paternity, and the deception involved in infidelity. In (...) this paper it is argued that there should not be compensation for infidelity and that reimbursement is appropriate where the claimant has made child support payments but has not taken on the social role of father. Where the claimant’s behaviour suggests a social view of fatherhood, on the other hand, claims for compensation are less coherent. Where the genetic model of fatherhood dominates, the “other” man (the woman’s lover and progenitor of the children) might also have a claim for the loss of the benefits of fatherhood. It is concluded that claims for reimbursement and compensation in cases of misattributed paternity produce the same distorted and thin view of what it means to be a father that paternity testing assumes, and underscores a trend that is not in the interests of children. (shrink)

Poor people predominate as a subgroup of those who take part in healthy volunteer research. They are subjected to minimised but unknown risks and unpleasant burdens so that the safety of new medicines can be evaluated. This is prima facie unfair especially given that the poor are often unable to access expensive medicines. Although participants in this kind of research often do receive compensation for their time, these payments are usually capped at a very low level. This paper defends a (...) version of a reimbursement model for the payment of research subjects. This model is practical, would benefit those without an income who take part in research, and would make it possible for those in regular work to take part in phase 1 research. (shrink)

Controlled Human Infection Model (CHIM) research involves the infection of otherwise healthy participants with disease often for the sake of vaccine development. The COVID-19 pandemic has emphasised the urgency of enhancing CHIM research capability and the importance of having clear ethical guidance for their conduct. The payment of CHIM participants is a controversial issue involving stakeholders across ethics, medicine and policymaking with allegations circulating suggesting exploitation, coercion and other violations of ethical principles. There are multiple approaches to payment: reimbursement, (...) wage payment and unlimited payment. We introduce a new Payment for Risk Model, which involves paying for time, pain and inconvenience and for risk associated with participation. We give philosophical arguments based on utility, fairness and avoidance of exploitation to support this. We also examine a cross-section of the UK public and CHIM experts. We found that CHIM participants are currently paid variable amounts. A representative sample of the UK public believes CHIM participants should be paid approximately triple the UK minimum wage and should be paid for the risk they endure throughout participation. CHIM experts believe CHIM participants should be paid more than double the UK minimum wage but are divided on the payment for risk. The Payment for Risk Model allows risk and pain to be accounted for in payment and could be used to determine ethically justifiable payment for CHIM participants.Although many research guidelines warn against paying large amounts or paying for risk, our empirical findings provide empirical support to the growing number of ethical arguments challenging this status quo. We close by suggesting two ways (value of statistical life or consistency with risk in other employment) by which payment for risk could be calculated. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:What Makes a Mental Disorder Mental?Jerome C. Wakefield (bio)Keywordsharmful dysfunction, mental disorder, intentionality, mental dysfunction, mental functioning, phenomenality, somatic disorderWhat makes a medical disorder mental rather than (exclusively) somatic or physical? Psychiatry to some extent depends for its existence as a medical specialty on the distinction between mental and somatic disorders, yet the history of this distinction presents a bewildering array of puzzling judgments, radical shifts, and seemingly arbitrary (...) distinctions. The historical observation that putative mental disorders are often reclassified as physical disorders as soon as their physiologic basis is understood further confuses matters. Moreover, recent debates about such classifications often seem to reflect desires to protect professional turf or obtain optimal reimbursement for treatment more than they do the application of a coherent conceptual distinction. No wonder that Brülde and Radovic (2006) disarmingly admit at the outset of their exploration of this question that there is a case to be made that their topic is relatively unimportant or even meaningless intellectually, a rare way to start an inquiry!Could there nonetheless be a cogent conceptual distinction lurking here? Brülde and Radovic usefully invite us to reframe the question, in effect as follows: Suppose we pay attention to professional and lay judgments as evidence but at the same time try to avoid being ensnared by the distortions resulting from turf issues and other pragmatic motives and constraints. Can we then identify some principled distinction in this domain that is worth making and that interestingly corresponds to the distinction generally made between mental disorders and strictly somatic disorders? Brülde and Radovic do not come to any confident or compelling conclusion about this.My answer, based on my harmful dysfunction analysis of disorder (Wakefield, 1992a, 1992b, 1999a, 1999b), is that a mental disorder is a harmful mental dysfunction, where a mental dysfunction is a failure of the capacity of some mental mechanism to perform a function for which it was biologically designed. I argue that, owing to a series of logical missteps, Brülde and Radovic needlessly reject this view. After some preliminary comments and clarifications, I defend the internal dysfunction approach from the objections posed by Brülde and Radovic, and then conclude by elaborating this view in some new ways. Note that Brülde and Radovic critique something they call the "internal cause view" of what makes a disorder mental, and they name others who hold that view. However, my work figures prominently in their discussion, and for expository simplicity, I will presume to simply construe their arguments as aimed at the harmful dysfunction analysis. [End Page 123]Clarifying the QuestionIt is easy to misconstrue the question "What makes a mental disorder mental" as demanding a precise account of the mental, an error to which Brülde and Radovic succumb in their repeated complaints that various writers do not present principled accounts of the mental but rely on lists of prototypical mental states or tentative guidelines to fix the reference of mental. We would need a precise definition of mental if the problem were how to classify cases in which it is ambiguous whether some phenomenon is mental or physical. We might imagine, for example, someone being genuinely puzzled as to whether inability to sleep is failure of a mental function or process. But this sort of puzzle about the boundaries of the mental is not the problem with which Brülde and Radovic are concerned; anyway, ambiguous cases may just be inherently ambiguous. The problem, which a crisp definition of mental will not resolve, is what relation mental states or mechanisms must have to a disorder to make it a mental disorder; must there be mental symptoms, or mental dysfunctions, or either one, and so on? But, even if a precise resolution of the nature of the mental is not needed, some notion of the mental domain is essential in pursuing this discussion. We can pick out the mental ostensively, by pointing to lots of examples (e.g., perception, motivation, emotion, thought, and sensation) much more confidently than we can define it in a principled way. But because Brülde and Radovic find fault in such ostensive reference fixing, let me... (shrink)

BackgroundThe use of a Community Advisory Board is one method of ensuring community engagement in community based research. To identify the process used to constitute CABs in Zambia, this paper draws on the perspectives of both research team members and CAB members from research groups who used CABs in Lusaka. Enabling and restricting factors impacting on the functioning of the CAB were identified.MethodsAll studies approved by the University of Zambia Bioethics Research Committee from 2008 – 2012 were reviewed to identify (...) those studies that were likely to include a CAB. Eight teams with studies that included a CAB were identified. For each of these studies, consent was obtained to conduct an informal interview with a research team member and to obtain contact details for one CAB member. In total 14 interviews were conducted with 8 research team members and 6 CAB members from 12–30 August 2013.ResultsIdentification of potential CAB members from the community and their participation in developing the terms of reference for CABs was perceived to have contributed to the success of the CAB. Due to the trust that the community had in members of their community the CABs were then in a stronger position to influence community participation in the research. Training of CAB members was identified as a factor that enhanced the functioning of a CAB. Lack of commitment and low literacy levels of CAB members posed a threat to the role of the CAB. Although compensation in the form of a stipend was not provided, CAB members were provided with transport reimbursements for attending meetings.ConclusionsSelection of CAB members from within the community contributed to community confidence in the CAB, enhancing its ability to act as an effective link between study team and community. This contributed positively to the conduct of the study and enhanced community awareness and acceptance of the research. However, establishment of study specific CABs has the potential to compromise CAB independence due to support provided by the research team in the form of transport reimbursements and other forms of support. Consideration should be given to establishing community wide Community Advisory Boards that could function across a range of studies to increase independent objective decision-making. (shrink)

Recently, Petersen provided in this journal a critical discussion of individualisation arguments in the context of social egg freezing. This argument underlines the idea that it is morally problematic to use individual technological solutions to solve societal challenges that women face. So far, however, there is a lack of empirical data to contextualise his central normative claim that individualisation arguments are implausible. This article discusses an empirical study that supports a contextualised reading of the normative work of Petersen. Based on (...) a qualitative interview study, we found that most women could make sense of this argument but addressed other concerns that are overlooked in the premises of moral individualisation arguments, for instance, the influence of relationship formation on the demand of egg freezing. Furthermore, women did not experience social egg freezing as morally problematic. Nonetheless, the interviewees pointed to a need of more societal solutions and even actively advocated for efforts to increase accessibility such as a partial reimbursement and better quality of information. The implications of these findings for empirical bioethics are discussed. While more research is needed, we argue that, in order to better address individualisation arguments and related ethical concerns, we need to contextualise normative evaluations within women’s moral reasoning. (shrink)

The definition of ‘patient’ is commonly taken for granted and considered as obvious, but the term is rather underconceptualised in the literature. In this paper, it will be argued that the criterion of suffering can be considered a sufficient criterion for a parent to be considered a secondary patient when their seriously ill child is receiving medical care (i.e. not necessarily the parents themselves) – these parents are sufferers in virtue of the suffering of others. The nature of parental and (...) child health and well-being is clearly relational and bidirectional, thus also a bidirectional and relational integration of parental and paediatric patient care is necessary. A genuine expansion of the concept ‘patient’ to parents, both practically and theoretically, can help to bring awareness to the closely intertwining, interacting and interdependent vulnerabilities of both parties, the potential conflicts of interests involved, and also to demand support and reduce hurdles, for example, in reimbursement by health insurers. Treating parents as patients will (1) help the affected child (the primary patient), as unhealthy and/or mentally unstable parents are likely to negatively influence a child's treatment and (2) prevent the parents (the secondary patients) from becoming primary patients themselves due to their suffering because of their child's illness. (shrink)

In the 1950s, estimates of the incidence of depression were fifty people per million; today the estimate is 100,000 per million. What was once defined as “anxiety” and treated with tranquilizers in the wake of the crisis of benzodiazipine dependence and the development of selective serotonin reuptake inhibitors became “depression.” And as SSRIs have been shown to be effective for treating other nervous conditions, such as panic disorder, estimates of their frequency have increased markedly as well. Disease increasingly means whatever (...) we have a reimbursable treatment for. (shrink)

Using payment to recruit research subjects is a common practice, but it raises ethical concerns that coercion or undue inducement could potentially compromise participants’ informed consent. This is the first national study to explore the attitudes of IRB members and other human subjects protection professionals concerning whether payment of research participants constitutes coercion or undue influence, and if so, why. The majority of respondents expressed concern that payment of any amount might influence a participant’s decisions or behaviors regarding research participation. (...) Respondents expressed greater acceptance of payment as reimbursement or compensation than as an incentive to participate in research, and most agreed that subjects are coerced if the offer of payment makes them participate when they otherwise would not or when the offer of payment causes them to feel that they have no reasonable alternative but to participate . Views about undue influence were similar. We conclude that human subjects protection professionals hold expansive and inconsistent views about coercion and undue influence that may interfere with the recruitment of research participants and impede valuable research. (shrink)

The federal government's introduction in 1983 of DRG‐based reimbursement for Medicare patients shook the entire health care industry into the vigorous and dramatic cost containment efforts which today are reshaping health care in America.

The experience of the use of applied containerized biomedical software tools in cloud environment is summarized. The reproducibility of scientific computing in relation with modern technologies of scientific calculations is discussed. The main approaches to biomedical data preprocessing and integration in the framework of the intelligent analytical system are described. At the conditions of pandemic, the success of health care system depends significantly on the regular implementation of effective research tools and population monitoring. The earlier the risks of disease can (...) be identified, the more effective process of preventive measures or treatments can be. This publication is about the creation of a prototype for such a tool within the project «Development of methods, algorithms and intelligent analytical system for processing and analysis of heterogeneous clinical and biomedical data to improve the diagnosis of complex diseases», implementted by the V.M. Glushkov Institute of Cybernetics, National Academy of Sciences of Ukraine, together with the United Institute of Informatics Problems, National Academy of Sciences of Belarus. The insurers, entering the market, can insure mostly low risks by facilitating more frequent changes of insurers by consumers and mixing the overall health insurance market. Socio-demographic variables can be risk adjusters. Since age and gender have a relatively small explanatory power, other socio-demographic variables were studied – marital status, retirement status, disability status, educational level, income level. Because insurers have an interest in beneficial diagnoses for their policyholders, they are also interested in the ability to interpret relevant information – upcoding: insurers can encourage their policyholders to consult with doctors more often to select as many diagnoses as possible. Many countries and health care systems use diagnostic information to determine the reimbursement to a service provider, revealing the necessary data. For processing and analysis of these data, software implementations of construction for classifiers, allocation of informative features, processing of heterogeneous medical and biological variables for carrying out scientific research in the field of clinical medicine are developed. The experience of the use of applied containerized biomedical software tools in cloud environment is summarized. The reproducibility of scientific computing in relation with modern technologies of scientific calculations is discussed. Particularly, attention is paid to containerization of biomedical applications, this permits to get reproducibility of the conditions in which the calculations took place, technologies of software pipelining of calculations, that allows to organize flow calculations, and technologies for parameterization of software environment, that allows to reproduce, if necessary, an identical computing environment. The main approaches to biomedical data preprocessing and integration in the framework of the intelligent analytical system are described. The experience of using the developed linear classifier, gained during its testing on artificial and real data, allows us to conclude about several advantages provided by the containerized form of the created application: it permits to provide access to real data located in cloud environment; it is possible to perform calculations to solve research problems on cloud resources both with the help of developed tools and with the help of cloud services; such a form of research organization makes numerical experiments reproducible, i.e. any other researcher can compare the results of their developments on specific data that have already been studied by others, in order to verify the conclusions and technical feasibility of new results; there exists a universal opportunity to use the developed tools on technical devices of various classes from a personal computer to powerful cluster. (shrink)

In this paper, I claim that live uterus donors ought to be considered for the possibility of compensation. I support my claim on the basis of comparable arguments which have already been applied to gamete donation, surrogacy, and other kinds of organ donation. However, I acknowledge that there are specificities associated with uterus donation, which make the issue of incentive and reward a harder ethical case relative to gamete donation, surrogacy, and other kinds of organ donation. Ultimately, I contend that (...) while reimbursement for the costs incurred by live uterus donors should be treated as a necessary ethical minimum, how much further we ought to remunerate uterus donations remains an open question. (shrink)

Hospitals in the United States have been engaging in the practice of returning immigrant patients, usually undocumented immigrant patients, to their country of origin when the patient has long-term medical needs for which no reimbursement is available. I argue that for such an action to be ethical, it must be done in accordance with the mission and values of hospitals. I describe three standards that an individual instance of repatriation must meet to be ethical: (1) patient best interests, (2) (...) medical due diligence, and (3) informed consent. I argue that these should form the basis for best practices in regard to medical repatriation for all hospitals in the United States. (shrink)

The rule of rescue describes the moral impulse to save identifiable lives in immediate danger at any expense. Think of the extremes taken to rescue a small child who has fallen down a well, a woman pinned beneath the rubble of an earthquake, or a submarine crew trapped on the ocean floor. No effort is deemed too great. Yet should this same moral instinct to rescue, regardless of cost, be applied in the emergency room, the hospital, or the community clinic? (...) -/- In health care, the desire to save lives at any cost must be reconciled with the reality of resource scarcity. As one example, the estimated cost for prophylactic Factor VIII to treat one patient with hemophilia for one year is $300,000. Costs of this magnitude have been accepted by public and private insurers in the developed world, even though, in principle, these sums could provide greater overall health benefit if allocated to pay for the unmet health care needs of many other patients. Looking forward, however, broad application of the rule of rescue will be increasingly untenable. But the moral instinct will remain: the desire to help those weakest among us, especially when their small numbers allow us to see them as unique individuals. What, then, is the ethical framework that can guide coverage and reimbursement decisions for orphan drugs into the future? (shrink)