The Issue of Reimbursement and Price Regulation of Medicinal Products during Provision of Health Services This master thesis deals with the price and reimbursement regulation of medicinal products in the Czech Republic and with selected problematic aspects of this field. The thesis describes and analyzes the issue in broader, especially economic, contexts and aims to give the reader a comprehensive view of the subject. The work itself is divided into nine chapters. The introductory chapter outlines the issue of prices of medicinal products in general and outlines healthcare reforms that have attempted to focus more or less successfully on problematic aspects of the field. The following chapter is devoted to explaining the terms that are key or somehow unclear to health or pharmaceutical law. The third chapter deals with an economic approach to regulation and aims to explain to readers why regulation by state authorities in modern society is in some cases important and in some cases even necessary. There are also described and explained the tools of regulation and at the conclusion of the chapter the economic approach is directly reflected in the situation of the market of medicinal products in the territory of the Czech Republic. The following chapter characterizes the actual entry of a particular...

O presente estudo procurou obter uma estimativa dos custos diretamente ligados ao atendimento de lesões traumáticas maxilofaciais em crianças e adolescentes, comparados com a população adulta acometida do mesmo agravo, bem como o perfil sóciodemográfico da população atendida em um Hospital Público do Município de São Paulo, Brasil,com o intuito de fornecer evidências para avaliação quantitaiva do dano em perícias odontolegais,. Material e Método. Os dados dos prontuários foram colhidos, no período de janeiro de 2002 a dezembro de 2008 dos pacientes atendidos no serviço de Cirurgia Buco-Maxilofacial de um hospital do município de São Paulo. As variáveis classificatórias foram descritivamente apresentadas em tabelas de contingência contendo frequências absolutas (n) e relativas (%). A associação entre elas foi avaliada com o teste Qui-quadrado ou teste da razão de verossimilhança. Para a análise dos custos diretos foram utilizados os valores de referência da Tabela do Sistema de Informações de Tratamento Ambulatorial do Sistema Único de Saúde- SIA-SUS do Ministério da Saúde. Resultados Do1.200 casos analisados, 419preencheram os requisitos da pesquisa. O grupo caso obteve 108 registros (faixa etária até 19 anos), e os demais foram classificados, como grupo controle (acima de 20 anos de idade). O grupo caso apresentou uma incidência de 1,5% ao ano de lesões traumáticas, e a média de idade no grupo caso foi de 14,35 +- 4,76 e no grupo controle foi de 33,65 +- 11,73 anos de idade. Em relação ao sexo predominaram os indivíduos do sexo masculino em ambos os subgrupos O tipo de tratamento cirúrgico prevaleceu em ambos os subgrupos, e o tempo de internação em dias foi cerca de duas vezes maior no grupo controle em relação ao grupo caso, entretanto as complicações foram mais freqüentes no grupo caso em relação ao grupo controle. Os tipos de lesões mais freqüentes no grupo caso foram as fraturas nasais/dentárias, seguidas das fraturas e mandíbula, e que no grupo controle o quadro inverteu-se. A distribuição de custos teve o maior número de casos na faixa de custos até R$500,00 em ambos os subgrupos amostrais A freqüência de ocorrência de complicações foi significativamente maior no grupo caso, em relação ao grupo controle, da mesma forma que os retornos ambulatoriais foram também significativamente maiores neste grupo. Conclusões A distribuição de custos teve o maior número de casos na faixa de custos até R$500,00 em ambos os subgrupos amostrais; esses custos foram calculados com base no repasse de verbas da Tabela de Valores do Sistema Único de Saúde, onde não esta discriminado o custo dos honorários profissionais. A valoração do dano nas atividades periciais deve considerar, além dos custos diretamente envolvidos com o atendimento do traumatizado, as consequências para suas atividades diárias especialmente quando se trata de criança ou adolescentes cuja função social ainda está por se definir / The aim of this study is to provide evidence for the quantitative assessment of injury in forensic dentistry investigation, thorough the estimate of costs directly linked to the care of maxillofacial trauma lesions in children and adolescents, compared to adults who suffered the same injuries, as well as trace a social demographic profile of the patients admitted in a public hospital in Sao Paulo. Material and Method. The hospital chart data were collected from January 2002 to December 2008 and the charts belonged to patients cared for by the Buco-Maxillofacial Surgery Department of a hospital in Sao Paulo. Classification variables were described in contingency tables which comprise absolute (n) and relative (%) frequencies. Their association was assessed using the chi-square test. Reference prices from the Ambulatory Care Price Table, provided by the Unified Health System (SIA-SUS), the government managed Public Health System in Brazil, were used to determine direct costs. Outcome: out of the 1200 cases analyzed, 419 matched the requisites of this survey. The case group comprised 108 cases (up to 19 years old) and the other 311 were classified as the control group (above 20 years old). The incidence rate of trauma lesions was of 1,5% per year in the case group and the average age was of 14,35 +-4,76, while in the control group, the average age was 33,65 +- 11,73. Male individuals prevailed in both groups and so did the surgical treatment. The number of days of hospital stay was about twice as big in the control group in relation to the case group. Complications, however, were more frequent in the case group. The most frequent kinds of lesion in the case group were the dental or nasal fractures, followed by jaw fractures, and this was directly opposite to what happened in the control group. The Unified Health System (SUS) reimbursed treatments of up to 500 reais in both groups. The frequency of complications and returns to the Ambulatory Care facilities were significantly higher in the case group. Conclusion: The reimbursement of expenses happened more frequently when treatment cost up to 500 reais in both sample groups. These costs were calculated taking reference prices from the Ambulatory Care Price Table, provided by Unified Health System (SUS). The prices dont include professional fees. When calculating how much to refund, the Government should take into account not only the direct costs involved in caring for the injured patient, but also the consequences such treatments have on their daily activities, especially when we consider that children and adolescents do not have a their social roles defined yet.

Reimbursement of costs in trial proceedings and enforcement proceedings Abstract Thesis Reimbursement of costs in trial proceedings and enforcement proceedings describes and evaluates selected concepts concerning the reimbursement of costs in trial proceedings and enforcement proceedings. The primary goal is to describe essence of reimbursement of costs and to answer this common question: "Who shall pay it in the end?" Thesis is dived into three parts. The thesis starts with introduction where author sets goals of the thesis and methods of scientific work to compile and process assigned subject. Furthermore there is briefly defined distinction between reimbursement of costs and payment of costs. The part is concluded with description of the goals of costs in proceedings and types of systems of reimbursement of costs. The first part of the thesis is concerned with reimbursement of costs in trial proceedings. The first chapter starts with reimbursement of costs in trial and adversarial proceedings. This chapter is the most extensive. It consists of description of reimbursement of costs and types of costs. There is also dedicated part to decisions and remedies concerning the reimbursement of costs. The second chapter is concerned with reimbursement of costs in trial and non-adversarial proceedings. This...

Healthcare in the Czech Republic is currently undergoing reform changes. The aim of the thesis is to evaluate the upcoming changes in the reimbursement of health care in hospitals. To achieve the goal is used as the literature, as well as proposed legislation and the case law. The practical part of the thesis focuses on the hospitals. Emphasis is placed on the analysis of mechanisms fixed costs reimbursement of health care and reimbursement of health care by the DRG method. The potential impact of reform measures is presented on the example of an extremely costly medical care (orphan drugs). Based on the information and analysis are in the final part of the thesis describes the effects of health reform on financing health care in hospitals. At the same time also outlined a possible solution to save the cost of medical equipment in the field of medicines.

En pharmaco-épidémiologie, la mesure de l’exposition médicamenteuse est fondamentale. Des données déclaratives recueillies par interrogatoire des sujets ou des données extraites des bases de remboursement de l’Assurance Maladie peuvent être utilisées. Les objectifs de ce travail étaient de comparer l’exposition mesurée à partir de ces deux sources de données et d’évaluer l’impact du choix de l’une ou l’autre source sur les mesures de risque dans les études étiologiques. Les travaux ont été conduits au sein de l’étude des Trois-Cités, cohorte de sujets âgés pour laquelle étaient disponibles des données déclaratives et de remboursement. La concordance entre les expositions issues des deux sources ou la validité de l’exposition issue de l’une par rapport à celle issue de l’autre ont été évaluées dans différents contextes. La survenue d’événements a été simulée dans la population et des études cas-témoins nichées ont été conduites pour évaluer l’association entre l’exposition issue de chaque source et chaque événement. Pour les médicaments cardiovasculaires, les mesures d’exposition étaient peu différentes entre les deux sources. L’impact du choix de l’une ou l’autre source sur les mesures d’association entre l’exposition et un événement était faible. Pour les benzodiazépines ou les anti-inflammatoires non stéroïdiens, des différences étaient observées entre les expositions issues des deux sources. Pour ces médicaments, l’association avec un événement pouvait varier selon la source utilisée. Pour des médicaments pris de manière irrégulière ou intermittente, le choix de la source de données pour la mesure de l’exposition peut donc être un élément déterminant. / In pharmacoepidemiology, assessment of drug exposure is fundamental. It can rely on data collected through patient interviews or extracted from healthcare insurance system databases recording reimbursement claims. This work aimed to compare drug exposure measured from these two data sources and to evaluate the impact of choosing one source or the other on risk estimates in etiological studies. It was conducted as part of the Three-City Study, a cohort of French elderly persons for which both interview and reimbursement data were available. Agreement between exposures measured from both sources or validity of exposure measured from one source with reference to that measured from the other were evaluated in different backgrounds. Simulated outcomes were generated in the study population and nested case-control studies were conducted in order to estimate the association between the drug exposure measured from each source and each simulated outcome. For cardiovascular system drugs, exposure measured from interview data was close to that measured from reimbursement data. The choice of one source or the other had few impact on the estimated associations between the exposure and an outcome. For benzodiazepines or non-steroidal anti-inflammatory drugs, exposure measured from both sources could differ. For these drugs, the association between the exposure measured from each source and an outcome could vary. For drugs that can be used irregularly or intermittently, the choice of the source of data for drug exposure assessment could thus be of great importance.

The purpose of this dissertation is to examine the extent of competition between generic products and therapeutic substitutes under different regulatory regimes in the European Union (EU) pharmaceutical industry. In particular, this study investigates generic competition among the five largest European pharmaceutical markets; the United Kingdom, Germany, France, Italy and Spain, with comprehensive IMS data for 10 years (1994-2003), in order to estimate the effect of generic entry on drug prices at the product level. This analysis finds that generic entry has a negative effect on prices in countries with free pricing originator market, whereas in EU countries with strict price and reimbursement regulation, generic competition is ineffective and/or counterproductive. Fewer generics and less competitive late entrants are consistent with incentives in regulated environments: low regulated prices for originator products discourage generic entry following patent expiration. These findings suggest that regulation of both manufacturers' prices and retail pharmacy prices undermines price competition in the off-patent sector, and that budgetary savings from generic price competition are not realized in countries with strict regulatory systems.

As part of healthcare reform through the Affordable Care Act of 2010, hospitals across the United States are being held accountable for providing a positive patient experience and will lose up to 2% of their reimbursement by 2017 if they fail to reach targeted scores. The purpose of this quality improvement project was to review the process used by a Georgia hospital to educate newly-hired nurses about customer service expectations and to provide recommendations for process improvement. Theoretical foundations supporting customer service included the caring philosophy of Mayeroff; the caring theories of Watson, Leininger, Boykin, and Nyberg; and Roy's adaptation theory. Using the plan-do-study-act model, the project began with a literature review to discover evidence-based customer service strategies. A qualitative evaluation was then conducted of the organizational documents (job description, annual review form, orientation checklists, clinical orientation record, the Standards of Behavior Form) and the educational slide presentations to determine how customer service was presented to new employees. The customer service strategies introduced during orientation and reinforced by the organization in employee evaluations were compared with evidence-based strategies. Improvement recommendations were developed and presented to the 13 nursing leaders of the organization. Materials developed to improve customer service included a poster for display, a tool for examining customer service strategies in hourly rounding, and a performance competency tool to assess nurses' customer service delivery. The project promotes social change by enhancing nurse-patient interactions, improving patients' perceptions of care, and increasing trust between the patients and the healthcare team to improve patient outcomes.

Extended hospital length of stay (LOS) causes increased health care costs and incidence of never events, such as hospital-acquired infections, pressure ulcers, and falls, which are not reimbursed by Medicare. This study examined if there would be a statistically significant decrease in the LOS of patients after the implementation of a discharge process improvement initiative (DPII), The model for improvement and small tests of change concept were used to guide the DPII at a hospital in northern California. Sources of data included archival data obtained from the hospital's quality improvement department that showed LOS prior to and after the implementation of the DPII. The LOS for 2015 and 2017 were compared using the t test for independent samples. The LOS in 2015 was longer (M = 4.59, SD = 3.66) than in 2017 (M = 4.09, SD = 3.81), a statistically significant difference, M = 0.50, 95% CI [0.32, 0.67], t (77) = 5.574, p = .005, d = 1.3, showing that the implementation of the DPII led to a reduction in the LOS. This reduction cannot be attributed solely to the DPII because other projects were implemented at the same time, such as the Clinical Decisions Unit and multidisciplinary rounds. Future research could focus on the relationship between reduced LOS and readmission and the degree of collaboration among health care team members. The implications of this study for social change include the potential to lower health care costs and increase patients' awareness of their responsibility for their own health.

Background The European level of alcohol consumption, and the subsequent burden of disease, is high compared to the rest of the world. While screening and brief interventions in primary healthcare are cost-effective, in most countries they have hardly been implemented in routine primary healthcare. In this study, we aim to examine the effectiveness and efficiency of three implementation interventions that have been chosen to address key barriers for improvement: training and support to address lack of knowledge and motivation in healthcare providers; financial reimbursement to compensate the time investment; and internet-based counselling to reduce workload for primary care providers. Methods/design In a cluster randomized factorial trial, data from Catalan, English, Netherlands, Polish, and Swedish primary healthcare units will be collected on screening and brief advice rates for hazardous and harmful alcohol consumption. The three implementation strategies will be provided separately and in combination in a total of seven intervention groups and compared with a treatment as usual control group. Screening and brief intervention activities will be measured at baseline, during 12 weeks and after six months. Process measures include health professionals’ role security and therapeutic commitment of the participating providers (SAAPPQ questionnaire). A total of 120 primary healthcare units will be included, equally distributed over the five countries. Both intention to treat and per protocol analyses are planned to determine intervention effectiveness, using random coefficient regression modelling. Discussion Effective interventions to implement screening and brief interventions for hazardous alcohol use are urgently required. This international multi-centre trial will provide evidence to guide decision makers. / <p>Funding Agencies|European Communitys Seventh Framework Program|259268|The Netherlands Organisation for Health Research and Development (ZonMW)|200310017|FP7 EC Grant||</p>

This study investigates the required implementation of the System of Choice in the Swedish County Council of Västerbotten. The System of Choice is a national law with the objective to improve efficiency within primary care in Sweden. This was done by opening the market for more competition and giving the citizens the right to choose where to seek care. The reform was a big change for the organisation of health provision, which had up until the reform been characterized by monopolistic behaviour by county councils as dominant firms. At the time of this study it had been three years since the beginning of Health Choice, which is the name for the reform in Västerbotten. The aim of this research was to find out if the way in which Västerbotten County Council has chosen to shape Health Choice has led to the fulfilment of the objective of increased competition and thus higher motivation to perform quality care. This has been done by examining the development of the Health Choice and its reimbursement system through the eyes of the primary care providers. The study has further looked at the reasons underlying the result and ways to improve it. This area is not new ground for research. The organisation of health care is a popular topic all over the world since the population is growing and becoming older, thus putting increased pressure on the provision of health care (WHO, 2010, p. VI). Research has however showed that the optimal organisation of a reimbursement system for the primary care largely depends upon local conditions (Anell, 2005, p. 61). Since there is little previous in-depth information about the outcome of the Health Choice, the approach of this study has been inductive. Due to this exploratory and explanatory nature of the study a qualitative approach was applied. The data-collection has been done through 14 semi-structured interviews of about an hour each. To be able to catch the effects of the reimbursement system 11 of the interviews were conducted with health centre directors, representing both private and public providers as well as the different regions within the county council. The three other interviews were held with representatives from the county council and the supporting department for the Primary Care Group. The interviews generated transcribed text of 250 pages. This material was sifted and processed using the template analysis approach. The result shows that the county council‟s attitude to the Health Choice has negatively affected how it has been implemented. Too little resources have been spent on the purchasing department that is responsible for the development of the Health Choice and its reimbursement system. These factors have led to an organisation of Health Choice that discourages private providers to enter the primary care market in Västerbotten and there has thus only been a small increase in competition. A complex system with low continuity, lack of information and focus on the wrong things have led to the value of the reimbursement system as a motivational tool for increasing cost effectiveness and quality of care to be low.