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2.
Med Leg J ; 88(2): 90-97, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32490743

RESUMO

We consider various types of litigation that may follow the Covid-19 pandemic, including: claims against National Health Service (NHS) Trusts by patients who have contracted the coronavirus (or by their bereaved families), claims by NHS staff against their employer for a failure to provide any or adequate personal protective equipment or testing, commercial claims arising from the procurement of medical supplies, the potential liabilities to those who suffer adverse reactions to any vaccine and the guidance issued by the regulators in relation to subsequent disciplinary action.


Assuntos
Betacoronavirus , Infecções por Coronavirus/epidemiologia , Responsabilidade Legal , Pneumonia Viral/epidemiologia , Contratos/legislação & jurisprudência , Transmissão de Doença Infecciosa/legislação & jurisprudência , Disciplina no Trabalho/legislação & jurisprudência , Emprego/legislação & jurisprudência , Pessoal de Saúde , Humanos , Imperícia/legislação & jurisprudência , Exposição Ocupacional/legislação & jurisprudência , Pandemias , Reino Unido/epidemiologia , Vacinação/legislação & jurisprudência
3.
Value Health ; 23(4): 421-424, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32327158

RESUMO

Steep increases in prices and spending on prescription drugs in the United States have triggered public outrage and questions over their value. Value-based pricing has emerged as a preferred alternative to prices determined by what the market will bear. In response, manufacturers and health plans have begun to publicize their efforts to engage in outcomes-based contracts and long-term financing agreements, which they describe as value-based. Nevertheless, both contracting approaches perpetuate existing distortions in the financial incentives of supply chain and prescribing intermediaries, and fail to realign the prices of drugs to their value to patients, the healthcare system, or society. This commentary describes the challenges of managing drugs according to their value, and describes several alternatives that promise greater impact than contracting strategies.


Assuntos
Contratos/economia , Assistência à Saúde/economia , Medicamentos sob Prescrição/economia , Aquisição Baseada em Valor/economia , Custos e Análise de Custo/economia , Assistência à Saúde/organização & administração , Custos de Medicamentos , Indústria Farmacêutica/economia , Humanos , Estados Unidos
4.
Value Health ; 23(4): 434-440, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32327160

RESUMO

OBJECTIVES: Outcomes-based contracts tie rebates and discounts for expensive drugs to outcomes. The objective was to estimate the utility of outcomes-based contracts for diabetes medications using real-world data and to identify methodologic limitations of this approach. METHODS: A population-based cohort study of adults newly prescribed a medication for diabetes with a publicly announced outcomes-based contract (ie, exenatide microspheres ["exenatide"], dulaglutide, or sitagliptin) was conducted. The comparison group included patients receiving canagliflozin or glipizide. The primary outcome was announced in the outcomes-based contract: the percentage of adults with a follow-up hemoglobin A1C <8% up to 1 year later. Secondary outcomes included the percentage of patients diagnosed with hypoglycemia and the cost of a 1-month supply. RESULTS: Thousands of adults newly filled prescriptions for exenatide (n = 5079), dulaglutide (n = 6966), sitagliptin (n = 40 752), canagliflozin (n = 16 404), or glipizide (n = 59 985). The percentage of adults subsequently achieving a hemoglobin A1C below 8% ranged from 83% (dulaglutide, sitagliptin) to 71% (canagliflozin). The rate of hypoglycemia was 25 per 1000 person-years for exenatide, 37 per 1000 person-years for dulaglutide, 28 per 1000 person-years for sitagliptin, 18 per 1000 person-years for canagliflozin, and 34 per 1000 person-years for glipizide. The cash price for a 1-month supply was $847 for exenatide, $859 for dulaglutide, $550 for sitagliptin, $608 for canagliflozin, and $14 for glipizide. CONCLUSION: Outcomes-based pricing of diabetes medications has the potential to lower the cost of medications, but using outcomes such as hemoglobin A1C may not be clinically meaningful because similar changes in A1C can be achieved with generic medications at a far lower cost.


Assuntos
Contratos/economia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Avaliação de Resultados em Cuidados de Saúde/métodos , Idoso , Canagliflozina/administração & dosagem , Canagliflozina/economia , Estudos de Coortes , Diabetes Mellitus Tipo 2/economia , Exenatida/administração & dosagem , Exenatida/economia , Feminino , Seguimentos , Glipizida/administração & dosagem , Glipizida/economia , Peptídeos Semelhantes ao Glucagon/administração & dosagem , Peptídeos Semelhantes ao Glucagon/análogos & derivados , Peptídeos Semelhantes ao Glucagon/economia , Humanos , Hipoglicemiantes/economia , Fragmentos Fc das Imunoglobulinas/administração & dosagem , Fragmentos Fc das Imunoglobulinas/economia , Masculino , Pessoa de Meia-Idade , Proteínas Recombinantes de Fusão/administração & dosagem , Proteínas Recombinantes de Fusão/economia , Fosfato de Sitagliptina/administração & dosagem , Fosfato de Sitagliptina/economia
6.
Value Health ; 23(4): 418-420, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32327157

RESUMO

In response to rising healthcare costs, value-based arrangements (VBAs) have emerged as a mechanism for transforming how we pay for high-cost therapies. As we think about how VBAs fit into the larger effort of the United States healthcare system to transition to value-based payment, it is important to consider the strengths and limitations associated with this model and to set appropriate expectations for what VBAs can realistically achieve. For example, for VBAs to meaningfully affect overall healthcare spending, there needs to be a sufficient number of products that meet the ideal criteria for a value-based contract. These products also need to represent a meaningful share of healthcare spending, and the VBA contracts need to be designed with enough financial risk to actually influence spending. Although there are limited data about the components of current contracts (eg, how much financial risk is involved, product and class specifications), VBAs will likely not be a singular solution for improving healthcare cost containment. Instead, VBAs offer an opportunity for the US healthcare system to achieve higher value for dollars spent when implemented in combination with other value-based payment mechanisms and policies that disincentivize low-value care.


Assuntos
Contratos/economia , Assistência à Saúde/economia , Custos de Cuidados de Saúde , Aquisição Baseada em Valor/economia , Controle de Custos , Humanos , Estados Unidos
7.
Value Health ; 23(2): 154-156, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32113619

RESUMO

Value-based pharmaceutical contracts (VBPCs) are performance-based reimbursement agreements between healthcare payers and pharmaceutical manufacturers in which the price, amount, or nature of reimbursement is tied to value-based outcomes. VBPCs are often complex, and the nature of who benefits and in what ways can be unclear. We discuss how VBPCs compare with value-based payer-provider arrangements in terms of performance-based reimbursements and alignment of incentives. In addition, we examine how VBPCs can affect costs, clinical outcomes, and access to medications. Because these contracts are unlikely to reduce costs in isolation, we recommend taking a patient-centered approach when developing VBPCs and tying VBPCs to more overarching payer drug cost reduction strategies.


Assuntos
Contratos/economia , Custos de Medicamentos , Indústria Farmacêutica/economia , Alocação de Recursos para a Atenção à Saúde/economia , Reembolso de Seguro de Saúde/economia , Seguro de Saúde Baseado em Valor/economia , Aquisição Baseada em Valor/economia , Redução de Custos , Análise Custo-Benefício , Gastos em Saúde , Acesso aos Serviços de Saúde/economia , Humanos , Formulação de Políticas
8.
Proc Natl Acad Sci U S A ; 117(13): 7103-7107, 2020 03 31.
Artigo em Inglês | MEDLINE | ID: mdl-32179683

RESUMO

Honest reporting is essential for society to function well. However, people frequently lie when asked to provide information, such as misrepresenting their income to save money on taxes. A landmark finding published in PNAS [L. L. Shu, N. Mazar, F. Gino, D. Ariely, M. H. Bazerman, Proc. Natl. Acad. Sci. U.S.A. 109, 15197-15200 (2012)] provided evidence for a simple way of encouraging honest reporting: asking people to sign a veracity statement at the beginning instead of at the end of a self-report form. Since this finding was published, various government agencies have adopted this practice. However, in this project, we failed to replicate this result. Across five conceptual replications (n = 4,559) and one highly powered, preregistered, direct replication (n = 1,235) conducted with the authors of the original paper, we observed no effect of signing first on honest reporting. Given the policy applications of this result, it is important to update the scientific record regarding the veracity of these results.


Assuntos
Contratos , Decepção , Humanos
9.
Value Health ; 23(2): 191-199, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32113624

RESUMO

BACKGROUND: Changes in the regulatory context enable faster approval of transformative medicines. They also lead to health technology assessment (HTA) agencies having to make decisions with less evidence. In response, HTA agencies have also initiated forms of conditional approval. When the evidence base for a new oncology treatment leaves substantial uncertainty, the new Cancer Drugs Fund allows the National Institute for Heath and Care Excellence to give the manufacturer two options: (1) offer a low price based on conservative assumptions and obtain immediate approval ("stick") or (2) wait until the evidence base has further matured before finalizing a potentially higher agreed price ("twist"). OBJECTIVES: The purpose of this article is to explain how, using the theoretical framework of the expected value of sample information, simulation methods can help inform a manufacturer's decisions when faced with the option to stick or twist. METHODS: We first summarize a general model to help frame the manufacturer's negotiating strategy. We then use a motivating case study, based on a hypothetical immunotherapy, to illustrate how manufacturers can use simulation methods to robustly characterize the uncertainty inherent to further data collection and incorporate this uncertainty within their decision making. RESULTS: Our approach allows us to estimate the commercial value of generating additional data (the difference between the estimated net present value of stick and twist). We test the sensitivity of the results to different assumptions via scenario analyses. CONCLUSIONS: This article shows that simulation methods can be used to help pharmaceutical managers make informed strategic decisions in contexts of uncertainty.


Assuntos
Antineoplásicos Imunológicos/economia , Antineoplásicos Imunológicos/uso terapêutico , Orçamentos , Contratos/economia , Tomada de Decisões , Técnicas de Apoio para a Decisão , Aprovação de Drogas/economia , Custos de Medicamentos , Desenvolvimento de Medicamentos/economia , Negociação , Avaliação da Tecnologia Biomédica/economia , Antineoplásicos Imunológicos/efeitos adversos , Simulação por Computador , Análise Custo-Benefício , Alocação de Recursos para a Atenção à Saúde/economia , Humanos , Modelos Econômicos , Modelos Estatísticos , Formulação de Políticas , Resultado do Tratamento , Incerteza
10.
Am J Orthod Dentofacial Orthop ; 157(2): 278-279, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32005480

Assuntos
Imperícia , Contratos
11.
Med Care ; 58(8): 674-680, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32049878

RESUMO

BACKGROUND: Starting in 2014, the Affordable Care Act mandated that Medicare Advantage (MA) contracts spend at least 85% of total revenue on claims and quality improvement [ie, the medical loss ratio (MLR)] and submit revenue and cost data annually in MLR reports. These reports can improve transparency of the financial performance of MA contracts. However, little is known about revenues and costs of insurers that participate in MA and its impacts on status changes in the following year. OBJECTIVE: To characterize revenues and costs of MA contracts in 2014, with a focus on MLRs and gross margins, and to assess heterogeneity in subsequent-year plan renewal and termination rates by gross margins. RESEARCH DESIGN: Cross-sectional data from MLR reports submitted in 2014 by MA contracts and from 2015 Part C & D Plan Crosswalk Files regarding plan renewal, termination, and other status changes from 2014 to 2015. SUBJECTS: Three hundred eighty-nine MA contracts. MEASURES: Primary outcomes are MLRs and gross margins. RESULTS: MLRs averaged 93% in 2014; 11% of contracts reported MLRs of at least 100%. Fifty-six percent reported negative margins, or costs that exceeded revenues. Seventeen percent of plans in contracts in the lowest quartile of gross margins were terminated in 2015, compared to under 5% of plans in the highest-margin contracts. CONCLUSIONS: In 2014, MA contracts reported MLRs greater than the mandatory minimum of 85%. Gross margins likely contribute to trends in plan and insurer availability. MLR reports from subsequent years can help explain fluctuations in insurers' participation in MA.


Assuntos
Contratos/economia , Administração Financeira/estatística & dados numéricos , Medicare Part C/economia , Contratos/normas , Contratos/estatística & dados numéricos , Estudos Transversais , Humanos , Medicare Part C/normas , Medicare Part C/estatística & dados numéricos , Estados Unidos
12.
J Psychol ; 154(3): 249-272, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31916918

RESUMO

With a basis in conservation of resources theory, this study investigates the relationship between employees' exposure to perceived contract breaches and their job performance, while also considering the mediating role of knowledge hiding and the moderating role of positive affectivity. Multisource, three-wave data from employees and their peers in Pakistani organizations reveal that breaches in the psychological contract hinder job performance, because employees respond with an unwillingness to contribute valuable knowledge to execute their job tasks. This mediating role of knowledge hiding is mitigated if employees can draw from their own positive affectivity trait. This study accordingly identifies a key factor, intentional attempts to conceal knowledge requested by other members, that can backfire and make employees suffer doubly: from unfulfilled organizational promises and from lower performance. It also reveals how this risk might be contained, that is, by encouraging employees' positive affect.


Assuntos
Afeto , Contratos/ética , Emprego/ética , Emprego/psicologia , Conhecimento , Modelos Psicológicos , Desempenho Profissional , Feminino , Humanos , Masculino , Negociação , Paquistão , Revelação da Verdade , Desempenho Profissional/normas
14.
J Clin Nurs ; 29(1-2): 75-84, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31512306

RESUMO

AIM: To develop a substantive theoretical explanation that makes sense of the decision-making process that clinical instructors use to place students on a learning contract. BACKGROUND: Clinical instructors are challenged with the task of objectively evaluating students using subjective tools such as anecdotal notes, diaries, unstructured observations and verbal feedback from other nurses. Clinical instructors' assessment decisions have a considerable impact on a variety of key stakeholders, not least of all students. DESIGN: Grounded theory method and its heuristic tools including the logic of constant comparison, continuous memoing and theoretical sampling to serve conceptualisation were used in the process of data collection and analysis. METHODS: Seventeen individual semi-structured interviews with clinical instructors in one university in Western Canada were conducted between May 2016-May 2017. Data were analysed using open, axial and selective coding consistent with grounded theory methodology. The study was checked for the Standards for Reporting Qualitative Research (SRQR) criteria (See Appendix S1). FINDINGS: Three subcategories, "brewing trouble," "unpacking thinking" and "benchmarking" led to the study's substantive theoretical explanation. "Gut feeling" demonstrates how clinical instructors reason in their decision-making process to place a student on a learning contract. CONCLUSION: Placing a student on a learning contract is impacted by personal, professional and institutional variables that together shift the process of evaluation towards subjectivity, thus influencing students' competency. A system-level approach, focusing on positive change through implementing innovative assessment strategies, such as using a smart phone application, is needed to provide some degree of consistency and objectivity. RELEVANCE TO CLINICAL PRACTICE: Making visible the objective assessments currently being done by clinical instructors has the potential to change organisational standards, which in turn impact patient and clinical outcomes.


Assuntos
Bacharelado em Enfermagem/métodos , Docentes de Enfermagem/psicologia , Estudantes de Enfermagem/psicologia , Canadá , Contratos , Avaliação Educacional/métodos , Teoria Fundamentada , Humanos , Intuição , Resolução de Problemas , Pesquisa Qualitativa
15.
J Shoulder Elbow Surg ; 29(1): 121-125, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31668501

RESUMO

BACKGROUND: The economic loss following ulnar collateral ligament reconstruction (UCLR) in Major League Baseball (MLB) pitchers has not been evaluated. The purpose of this study is to quantify the financial impact of UCLR on MLB teams. We hypothesize that MLB teams incur significant losses annually as a result of salaries paid to injured players following reconstruction. METHODS: Public records were accessed to identify MLB pitchers from January 1, 2004, to December 31, 2014, who had undergone UCLR. Contract terms and time away from competition were used to approximate economic loss. Successful return was considered when a pitcher returned to play in at least 1 Minor League Baseball (MiLB) or MLB game. RESULTS: One hundred ninety-four MLB pitchers underwent UCLR from 2004 to 2014, missing on average 180.2 days of the MLB regular season. Cost of recovery (COR) amounted to $395 million, averaging $1.9 million per player. Starting pitchers accounted for the largest total COR at $239.6 million, whereas closers had the largest economic loss per player ($3.9 million/player). Only 77% of pitchers returned to MLB play. CONCLUSION: UCLR has a substantial economic impact on MLB teams. Starting pitchers represented a majority of team cost, but closers represented higher costs per pitcher.


Assuntos
Beisebol/economia , Ligamento Colateral Ulnar/lesões , Traumatismos Ocupacionais/economia , Salários e Benefícios/economia , Reconstrução do Ligamento Colateral Ulnar/economia , Adulto , Beisebol/lesões , Contratos , Custos e Análise de Custo , Humanos , Masculino , Pessoa de Meia-Idade , Traumatismos Ocupacionais/cirurgia , Ocupações/economia , Volta ao Esporte/estatística & dados numéricos , Salários e Benefícios/estatística & dados numéricos , Fatores de Tempo , Adulto Jovem
16.
Tex Med ; 115(12): 30-34, 2019 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-31800090

RESUMO

Only patients can pick up their own prescriptions, and only patients can propel that medication into their own bodies. Physicians can educate, emphasize, and admonish - but at the end of the day, they can't restrain and "pill" a squirming, uncooperative patient like a dog or cat. It's up to patients to do the right thing for themselves. Yet, some health plans' quality programs are putting that onus on physicians - through medication adherence metrics that determine whether physicians and accountable care organizations (ACOs) in value-based contracts receive bonus payments.


Assuntos
Organizações de Assistência Responsáveis , Benchmarking , Adesão à Medicação , Papel do Médico , Médicos , Organizações de Assistência Responsáveis/economia , Organizações de Assistência Responsáveis/normas , Contratos , Fidelidade a Diretrizes , Humanos , Seguro Saúde , Medicaid , Medicare , Médicos/economia , Médicos/normas , Reembolso de Incentivo , Justiça Social , Sociedades Médicas , Texas , Estados Unidos
18.
J Law Health ; 33(1): 1-16, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31841615

RESUMO

Chronic Traumatic Encephalopathy (CTE) is a neurodegenerative brain injury that has become prevalent among high-contact professional sports, especially American football. More and more retired players are exhibiting symptoms of CTE and being diagnosed with CTE post-mortem. While the neuroscience community constantly releases studies showing a causal connection between brain trauma and CTE, the National Football League (NFL) continues to deny that any brain injury can arise from playing football. The NFL must implement provisions in their contracts to fully inform and protect players from this lethal brain injury. This article examines the repercussions of CTE, how players' contracts do and do not provide protections, and the possible provisions the NFL can implement in its contracts to adequately protect players of repeated brain trauma.


Assuntos
Traumatismos em Atletas/prevenção & controle , Concussão Encefálica/complicações , Encefalopatia Traumática Crônica/diagnóstico , Contratos/normas , Futebol Americano/lesões , Futebol Americano/legislação & jurisprudência , Sociedades/legislação & jurisprudência , Atletas , Autopsia , Concussão Encefálica/mortalidade , Encefalopatia Traumática Crônica/etiologia , Encefalopatia Traumática Crônica/mortalidade , Humanos , Masculino , Estados Unidos/epidemiologia
19.
Healthc Q ; 22(3): 21-25, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31845853

RESUMO

This case describes a competitive dialogue strategy to procure a cardiac program solution to strengthen performance, outcomes and value in an Ontario hospital. All major contracts for the cardiac program were expiring, offering a unique opportunity for procurement of innovation. Procurement was completed in two phases, with an additional request for proposals issued for the unique specialty products not included in the initial procurement. The implementation of contracts was monitored to ensure that outcomes and deliverables were achieved. The procurement for the entire cardiac program was complex; however, it resulted in substantial cost savings and value-added services for the cardiac program.


Assuntos
Equipamentos e Provisões/provisão & distribução , Administração Hospitalar/métodos , Inovação Organizacional , Contratos , Doença das Coronárias , Equipamentos e Provisões/economia , Humanos , Ontário , Estudos de Casos Organizacionais
20.
Ger Med Sci ; 17: Doc10, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31728135

RESUMO

The objective of clinical trials is to transfer findings gained from basic research to patients and to result in innovative treatment approaches. Along with basic research, results from clinical trials thus represent a core area of medical advances. As a location for clinical trials, Germany is currently well-positioned and internationally competitive. This is evident in its position as No. 2 in Europe and No. 3 worldwide - behind the US and UK - in clinical trials of pharmaceuticals [1]. Maintaining and further improving this favorable positioning as a location for clinical trials is in the mutual interest of all parties involved in the field of clinical research, patients, trial sites and sponsors of clinical trials. For patients, clinical trials offer opportunities to gain early access to innovative therapy options. In addition to the scientific interest from medical faculties, clinical research is thereby an important aspect for university clinics in Germany as they fulfill their medical care mandate. Their involvement in clinical trials gives physicians the ability to gather experience with new treatment approaches at an early stage and to pass this know-how on to their patients. A location's clinical research is thus an important competitive factor in terms of international comparison as well. Industry likewise benefits from the favorable research infrastructure in Germany, which provides rapid patient recruitment and outstanding quality of results obtained and can thus contribute to the early approval of new drugs. From the perspective of the authors, it is therefore essential that Germany continues to remain competitive as a location for conducting clinical trials, precisely because the number of clinical trials is decreasing overall. Companies themselves are in international competition internally and externally, which often creates a certain pressure on trial preparation and thus on the start of a clinical trial. To ensure that a clinical trial can begin early, it is essential that contracts related to the trial are concluded quickly and simply, including remuneration for participants and full, transparent and comprehensible coverage of content for the business relationship. The swift agreement of key contractual and budgetary aspects is therefore in the interest of everyone involved. Against this backdrop, the German Association of Medical Faculties (MFT), the German Association of Academic Medical Centers (VUD), the Coordination Center for Clinical Studies (KKS-Netzwerk) and the German Association of Research-Based Pharmaceutical Companies (vfa) have held joint discussions regarding an important aspect of the contract negotiations - the cost consideration of clinical trials. As a result of these talks, these organizations have developed and published joint "Recommendations for the preparation of a total services calculation for remuneration related to the conduct of a clinical trial in a trial center" [2], [3]. The parties concerned share the conviction that, against the backdrops described, it would be helpful if the potential contract partners had access to recommendations that offer examples of constantly recurring cost positions in order to more precisely determine remuneration related to the conduct of a clinical trial. This article explains how the "Recommendations for the preparation of a total services calculation for remuneration related to the conduct of a clinical trial in a trial center" [2], [3] were developed and provides an overview of their content.


Assuntos
Ensaios Clínicos como Assunto/organização & administração , Contratos , Ensaios Clínicos como Assunto/economia , Contratos/economia , Contratos/normas , Indústria Farmacêutica/economia , Indústria Farmacêutica/organização & administração , Alemanha , Humanos , Remuneração
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