Hospitals' financial performance across European countries: a scoping review protocol.

INTRODUCTION: Hospitals remain the cornerstone of health systems in European countries. Therefore, the financial sustainability of hospitals constitutes an important determinant of healthcare provision security. The fragmentary data available indicate that hospitals in many European countries are continuously facing financial deficits and/or insolvency problems. Yet a comparative analysis of hospital financial performance across European countries has been lacking. The proposed review will, therefore, fill in an important research gap and build a knowledge base on the topic of assessing and monitoring the financial sustainability of hospitals in Europe. The general objective is to identify, synthetise and map existing evidence on hospital financial performance across European countries. METHODS AND ANALYSIS: This scoping review will follow six stages: (1) defining the research question, (2) identifying relevant literature, (3) studies selection, (4) data extraction, (5) collating, summarising and reporting of results and (6) consultation process and involvement of knowledge users. The following databases will be searched:(1) Medline via PubMed, (2) Web of Science Core Collection, (3) Scopus and (4) ProQuest Central. In addition, a Google Engine search will also be performed. Furthermore, reference lists of relevant papers will be visually scanned to identify further studies of interest. The review will include both quantitative and qualitative empirical studies as well as theoretical papers and technical reports. The PRISMA extension for a Scoping Review checklist will be used for reporting. ETHICS AND DISSEMINATION: Formal ethical approval is not required because no primary data will be collected in this study. Results will be published in a peer-reviewed journal. The findings will also be disseminated through conference presentations and summaries to key stakeholders.

Development of a tool for assessing the performance of long-term care systems in relation to care transition: Transitional Care Assessment Tool in Long-Term Care (TCAT-LTC).

BACKGROUND: Improving the quality and safety of care transitions is a priority in many countries. Carrying out performance measurements play a significant role in improving quality of decisions undertaken by different actors involved in reforms. Therefore, the main objective of this paper is to present the development of an evaluation tool for assessing the performance of long-term care systems in relation to care transition, namely the Transitional Care Assessment Tool in Long-Term Care (TCAT-LTC). This study is performed as part of a larger European TRANS-SENIOR project. METHODS: The development of the TCAT-LTC involved three steps. First, we developed a conceptual model based on Donabedian's quality framework and literature review. Second, we carried out a thorough process of item pool generation using deductive (systematic literature review) and deductive-inductive methods (in-depth interviews) with experts in the field of long-term care. Third, we conducted preliminary validation of the tool by asking experts in research and practice to provide an opinion on a tool and to assess content validity. Future fourth step will involve a tool's pilot with country experts from Germany, the Netherlands and Poland. RESULTS: By applying methodological triangulation, we developed the TCAT-LTC, which consists of 2 themes, 12 categories and 63 items. Themes include organizational and financial aspects. Organizational aspects include categories such as communication, transfer of information, availability and coordination of resources, training and education of staff, education/support of the patient/informal caregiver, involvement of the patient/informal caregiver, telemedicine and e-Health, and social care. Financial aspects include categories such as primary care, hospital, and long-term care. We also present the instructions on the application of the TCAT-LTC. CONCLUSIONS: In this paper, we presented the development of the TCAT-LTC evaluation tool for assessing the performance of long-term care systems in relation to care transition. The TCAT-LTC is the first tool to assess the performance of long-term care systems in relation to care transition. Assessments can be carried out at the national and international level and enable to monitor, evaluate, and compare performance of the long-term care systems in relation to care transition within and across countries.

The 2021 plan for hospital care centralization in Poland - When politics overwhelms the policy process.

The health system in Poland is characterized by oversized hospital infrastructure, with simultaneous deficits in the ambulatory and long-term care sectors. The main challenges of the hospital sector involve i.a. weak stewardship and fragmented governance with a concurrent problem of persistent hospital debts as well as huge workforce deficits. The objective of this paper is to present the government's 2021 plan for hospital care centralization. The reform project aimed i.a. at improving hospital service coordination by implementing a professional and centralized system for hospital sector supervision and effective restructuration processes. The proposed regulation project focused on three major issues: (1) adjusting the existing hospital network towards better concentration of specialized services; (2) launching an independent central agency responsible for monitoring public hospital financial standing as well as initiating and/or managing hospitals restructuration processes; and (3) introducing a formal certification of hospital managers competencies. The reform plans were developed in a relatively short time frame, with a top-down approach and strongly pushed towards the adoption in 2022. Many of the health system stakeholders were strongly opposed to the project which, in connection with new challenges faced by the health system in 2022 (the economic crisis) led the reform suspension. At the same time, a new restructuration and debt relief programme for public hospitals was announced.

Changes in the use and uptake of a national out-of-hours telephone triage service by younger and older patients seeking non-urgent unplanned care surrounding the COVID-19 pandemic in Flanders (Belgium).

BACKGROUND: This study seeks to examine if and how the COVID-19 pandemic has prompted changes in the use and uptake of a national out-of-hours (OOH) telephone triage service by younger and older patients seeking non-urgent unplanned care in Flanders (Belgium). METHODS: A descriptive study was conducted using registry data obtained from the 1733 OOH telephone triage service in a Flemish region of Belgium. All calls received between 1 January 2019 and 31 December 2020 were analyzed. RESULTS: A significant association was found between patient age and period of call (χ2 = 594.54, p < .001). Calls made to the 1733 OOH telephone triage service were significantly less likely to be dispatched to a higher level of urgency by operators compared to calls made before the COVID-19 period (OR = 0.80, 95% CI [0.74-0.85]). While calls concerning older adults were significantly more likely to be dispatched to a higher level of urgency by operators compared to younger adults (regardless of period of call) (65 to 74 yrs: OR = 5.75, 95% CI [4.86-6.80]; 75 to 84 yrs: OR = 15.21, 95% CI [13.18-17.56]; ≥ 85 yrs: OR = 28.77, 95% CI [25.01-33.09]), only 6.7% of all COVID-19 related calls involved older adults over 65 years of age. CONCLUSION: Findings showed that there was a general decline in the number of calls dispatched to a higher level of urgency by operators during the COVID-19 period but that there were differences in the use and uptake of these services by younger and older age segments.

Eating Choices-The Roles of Motivation and Health Literacy: A Cross-Sectional Study.

Food choices are determined by intrinsic and extrinsic product characteristics, biological and physiological features, psychological factors, and situational and socio-cultural factors. Self-determination theory offers the explanation of health behavior change identifying motivations located along a continuum of autonomy. Another approach to the motivations guiding health behaviors, including food choices, relies on distinguishing thematic categories. Health motivations seem to be an obvious determinant of health behaviors, but final decisions regarding health are also the effect of other types of motivations such as economic, cultural, or emotional. The role of marketing pressure in modern society is perceived to be an important source of motivation for purchasing food and other products. The Motivation-Opportunity-Ability (MOA) framework was initially proposed in order to explain the processing of brand information from advertisements and was later expanded to other areas, including health and nutritional behaviors. The aim of this study was the analysis of determinants of food choices. We have developed a common regression model including six categories of motivations addressed by the Eating Motivations Scale and three health literacy types corresponding with element of ability from the MOA framework, adjusted for socio-demographic factors, health status, and the use of the Internet and TV. The analysis was performed on data from a computer-assisted web-based interviewing (CAWI) survey among 2008 adult Internet users completed in May 2022. The uni- and multivariate linear regression models were developed with the Index of Unhealthy Food Choices (IUFC), calculated based on the responses to items asking about the frequency of the consumption of twelve food categories. Univariate modeling revealed that IUFC is significantly associated with health, food, and e-health literacies and with five out of six eating motivations. However, the multivariate regression model yielded significant associations only for eating motivations but not for the three literacy scores. Health motivation was negatively associated with IUFC (B, standard error (SE): 0.83, 0.07; 95% confidence interval (95% CI): 0.98-0.69), but positively with emotional (B, SE: 0.22, 0.04; 95% CI: 0.14-0.3), economic (B, SE: 0.41, 0.08; 95% CI: 0.25-0.56), and marketing (B, SE: 0.62, 0.08; 95% CI: 0.47-0.78) motivations. Our findings suggest that motivations guiding food choices may prevail over the element of 'ability' distinguished in the frameworks and models that explain people's behaviors, including behaviors relating to health. Thus, it is essential to emphasize development of appropriate motivations and not only to provide knowledge and skills. Furthermore, one should also remember motivations other than health motivations when searching for the determinants of health behaviors.

Associations between the COVID-19 Pandemic and Hospital Infrastructure Adaptation and Planning-A Scoping Review.

The SARS-CoV-2 pandemic has put unprecedented pressure on the hospital sector around the world. It has shown the importance of preparing and planning in the future for an outbreak that overwhelms every aspect of a hospital on a rapidly expanding scale. We conducted a scoping review to identify, map, and systemize existing knowledge about the relationships between COVID-19 and hospital infrastructure adaptation and capacity planning worldwide. We searched the Web of Science, Scopus, and PubMed and hand-searched gray papers published in English between December 2019 and December 2021. A total of 106 papers were included: 102 empirical studies and four technical reports. Empirical studies entailed five reviews, 40 studies focusing on hospital infrastructure adaptation and planning during the pandemics, and 57 studies on modeling the hospital capacity needed, measured mostly by the number of beds. The majority of studies were conducted in high-income countries and published within the first year of the pandemic. The strategies adopted by hospitals can be classified into short-term (repurposing medical and non-medical buildings, remote adjustments, and establishment of de novo structures) and long-term (architectural and engineering modifications, hospital networks, and digital approaches). More research is needed, focusing on specific strategies and the quality assessment of the evidence.

Key Care Provision Aspects That Affect Care Transition in the Long-Term Care Systems: Preliminary Review Findings.

The aim of this brief report is to present the protocol and preliminary findings of a systematic review on key aspects of care provision that affect care transition of older adults 60+ within the long-term care systems. This brief report describes and classifies the relevant literature found in the review with the purpose to provide a base for further full systematic reviews, and to outlines a model of organizational and financing aspects that affect care transition. Our search was conducted in MEDLINE, Embase and CINAHL on 2 March 2020, before the COVID-19 pandemic. The protocol was registered at the International Prospective Register of Systematic Reviews (number: CRD42020162566). Ultimately, 229 full-text records were found eligible for further deliberation. We observed an increase in the number of publications on organizational and financial aspects of care transition since 2005. Majority of publications came from the United States, United Kingdom and Australia. In total, 213 (92%) publications discussed organizational aspects and only 16 (8%) publications were related to financial aspects. Records on organizational aspects were grouped into the following themes: communication among involved professional groups, coordination of resources, transfer of information and care responsibility of the patient, training and education of staff, e-health, education and involvement of the patient and family, social care, and opinion of patients. Publications on financial aspects were grouped into provider payment mechanisms, incentives and penalties. Overall, our search pointed out various care provision aspects being studied in the literature, which can be explored in detail in subsequent full systematic reviews focused on given aspects. We also present a model based on our preliminary findings, which enables us to better understand what kind of provision aspects affect care transition. This model can be tested and validated in subsequent research. Understating factors that affect care transition is crucial to improve the quality of transitions and ultimately the outcomes for the patients.

Do financial aspects affect care transitions in long-term care systems? A systematic review.

BACKGROUND: Suboptimal care transitions of older adults may ultimately lead to worse quality of care and increased costs for the health and social care systems. Currently, policies and financing often focus on care in specific settings only, and neglect quality of care during transitions between these settings. Therefore, appropriate financing mechanisms and improved care coordination are necessary for effective care transitions. This study aims to review all available evidence on financial aspects that may have an impact on care transitions in LTC among older adults. METHODS: This systematic review was performed as part of the European TRANS-SENIOR project. The databases Medline, EMBASE (Excerpta Medica Database) and CINAHL (Cumulated Index to Nursing and Allied Health Literature) were searched. Studies were included if they reported on organizational and financial aspects that affect care transitions in long-term care systems. RESULTS: All publications included in this review (19 studies) focused specifically on financial incentives. We identified three types of financial incentives that may play a significant role in care transition, namely: reimbursement mechanism, reward, and penalty. The majority of the studies discussed the role of rewards, specifically pay for performance programs and their impact on care coordination. Furthermore, we found that the highest interest in financial incentives was in primary care settings. CONCLUSIONS: Overall, our results suggest that financial incentives are potentially powerful tools to improve care transition among older adults in long-term care systems and should be taken into consideration by policy-makers. TRIAL REGISTRATION: A review protocol was developed and registered in the International Prospective Register of Systematic Reviews (PROSPERO) under identification number CRD42020162566 .

Balancing financial incentives during COVID-19: A comparison of provider payment adjustments across 20 countries.

Provider payment mechanisms were adjusted in many countries in response to the COVID-19 pandemic in 2020. Our objective was to review adjustments for hospitals and healthcare professionals across 20 countries. We developed an analytical framework distinguishing between payment adjustments compensating income loss and those covering extra costs related to COVID-19. Information was extracted from the Covid-19 Health System Response Monitor (HSRM) and classified according to the framework. We found that income loss was not a problem in countries where professionals were paid by salary or capitation and hospitals received global budgets. In countries where payment was based on activity, income loss was compensated through budgets and higher fees. New FFS payments were introduced to incentivize remote services. Payments for COVID-19 related costs included new fees for out- and inpatient services but also new PD and DRG tariffs for hospitals. Budgets covered the costs of adjusting wards, creating new (ICU) beds, and hiring staff. We conclude that public payers assumed most of the COVID-19-related financial risk. In view of future pandemics policymakers should work to increase resilience of payment systems by: (1) having systems in place to rapidly adjust payment systems; (2) being aware of the economic incentives created by these adjustments such as cost-containment or increasing the number of patients or services, that can result in unintended consequences such as risk selection or overprovision of care; and (3) periodically evaluating the effects of payment adjustments on access and quality of care.

Assessing Policy Challenges and Strategies Supporting Informal Caregivers in the European Union.

Cost containment and the preferences of older adults are important stimuli for encouraging the provision of informal care worldwide. Nevertheless, informal caregiving can have negative effects on caregiver's health, wellbeing, and employment opportunities. Moreover, it is questionable whether informal caregivers can substantially contribute to meeting the increasing demand for care or serve as a substitute for formally provided services. This commentary assesses strategies to remediate the negative effects of caregiving and ultimately to improve informal caregiving and to support their critical role in European long-term care systems. Cash benefits are a particularly common method of supporting informal caregivers; paid and unpaid leave, and flexible work arrangements are the most prevalent measures to support family caregivers within labor market policy, specifically. Providing training and counseling services to individuals engaged in informal care is a strategy used to support caregivers at home. Disparities in the level of support provided to informal caregivers across the European Union need to be addressed. A lack of supporting policies increases the likelihood that caregivers experience negative physical and psychosocial health problems, as well as unemployment and impoverishment.

Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe.

BACKGROUND: The reimbursement of orphan drugs (OD) is an increasingly important for country policymakers, and still insufficiently understood, especially in Central and Eastern Europe. The aim of this research was to provide a comprehensive description of country-specific health technology assessment (HTA) policies as well as evaluate the percentage of HTA recommendations and reimbursement decisions for oncology OD. In addition, the study was designed to elucidate the impact of reimbursement of these drugs on the public budget and the agreement between HTA recommendations and reimbursement decisions in the analysed countries. A questionnaire survey was used to collect data on the reimbursement status, HTA recommendation, marketing authorisation, and public expenses on reimbursement in 2014, 2015, and 2016 for all oncology drugs with an orphan designation by the European Medicine Agency in 2017 in Bulgaria, Croatia, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, and Slovakia. The agreement between the HTA recommendation and reimbursement status was assessed using the kappa coefficient. The Pearson's correlation was used to analyse the relationship between gross domestic product (GDP) and GDP per capita and reimbursement expenses. RESULTS: A total of 36 drugs were analysed (25% conditionally approved; 5.56% approved under exceptional circumstances). The share of reimbursed drugs ranged from 11.11% in Latvia to 41.67% in Poland. The highest share of positive recommendations was observed for Bulgaria and Estonia (36.11%), and the lowest, for Latvia (11.11%). The agreement varied from 0.4 for Poland to 1 for Latvia, Hungary, and Slovakia. Expenses were correlated with GDP (0.95 [0.81-0.99]), and not with GDP per capita (0.54 [- 0.136 to 0.873]). Expenses per capita were not correlated with GDP per capita (0.52 [- 0.15 to 0.87]). CONCLUSIONS: In Hungary, Latvia, and Slovakia, a positive recommendation was associated with a reimbursement, and a negative one, with the lack of reimbursement. The reimbursement of oncology OD is associated with a growing burden for public budget, and the expenses are correlated with the total GDP. The highest share of drugs with any recommendation was observed in Poland, and the lowest, in Latvia and Romania. The share of reimbursed drugs was the lowest in Latvia and the highest in Poland.

What next after the 'commercialization' of public hospitals? Searching for effective solutions to achieve financial stability of the hospital sector in Poland.

The problem of hospital indebtedness has fraught the Polish health care sector for many decades. While it is largely attributed to the shortcomings of the legal form of the independent public health care unit (SPZOZ), which is the main legal form in which public hospitals operate in Poland, analysis of hospital indebtedness shows that the problem had been apparent before this legal form was introduced in 1999. The problem also did not appear to diminish with the transformation of the SPZOZs into Commercial Code companies, which effectively started in 2011 and was recently halted. While the shortcomings of the legal forms (SPZOZ and others) in which public hospitals operated did contribute to the accumulation of debts in the hospital sector, limited public spending on health and certain reforms were also to blame. Further, repeated rounds of debt reduction financed by the state have likely instilled the conviction among the hospital directors that debts would always be cleared eventually and provided little incentive for prudent financial management. While the government has recently pledged to increase public spending on health, this alone does not guarantee to resolve the problem of hospital indebtedness. Other key changes, such as implementing rational financial management in the hospitals and shifting more care from hospitals to primary and long-term care, are also needed.

[ASSESSMENT OF THE FINANCIAL STANDING OF SELECTED RESEARCH INSTITUTES SUPERVISED BY THE MINISTER OF HEALTH IN 2014-2018].

OBJECTIVE: The aim: The purpose of this study is the analysis of the financial situation of the institutes supervised by the Minister of Health in the period 2014-2018. PATIENTS AND METHODS: Material and methods: The study group consisted of 10 institutes that conducted inpatient and / or outpatient medical activities in 2018. Data to analysis derived from financial statements of research institutes from 2014 to 2018. The selection of financial indicators to ratio analysis is based on Ministry of Health ordinance from 2017. RESULTS: Results: The situation of the analyzed hospitals is difficult, with the difference between individual entities. The analyzed units were characterized by high net losses (9 out of 10 units generated a loss each year) low value of revenues in relation to costs and high share of remuneration in the structure of operating costs. There was no visible financial situation improvement per year. Simultaneously, in 2018 the difference between units were major: on a point scale 0 -70 ranged from: 51 points (73%) at the Institute of Physiology and Pathology of Hearing to 9 points (13%) at the Institute of Polish Mother's Health Center. The results are consistent with the conclusions of the Supreme Audit Office's reports, that baseline, medical institutes do not pursue a sustainable policy. CONCLUSION: Conclusions: Based on the analyzed data, it can be concluded that the economic situation of these units in 2014-2018 is difficult and has not changed much compared to previous periods.

Poland: Health System Review.

This analysis of the Polish health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. In late 2017, the Polish government committed to increase the share of public expenditures on health to 6% of GDP by 2024. If the GDP continues to grow in the years to come, this will present an opportunity to tackle mounting health challenges such as socioeconomic inequalities in health, high rates of obesity, rising burden of mental disorders and population ageing that put strain on health care resources. It is also an opportunity to tackle certain longstanding imbalances in the health sector, including overreliance on acute hospital care compared with other types of care, including ambulatory care and long-term care; shortages of human resources; the negligible role of health promotion and disease prevention vis-a-vis curative care; and poor financial situation in the hospital sector. Finally, the additional resources are much needed to implement important ongoing reforms, including the reform of primary care. The resources have to be spent wisely and waste should be minimized. The introduction, in 2016, of a special system (IOWISZ) of assessing investments in the health sector that require public financing (including from the EU funds) as well as the work undertaken by the Polish health technology assessment (HTA) agency (AOTMiT), which evaluates health technologies and publicly-financed health policy programmes as well as sets prices of goods and services, should help ensure that these goals are achieved. Recent reforms, such as the ongoing reform of primary care that seeks to improve coordination of care and the introduction of the hospital network, go in the right direction; however, a number of longstanding unresolved problems, such as hospital indebtedness, need to be tackled.

The 2017 reform of the hospital sector in Poland - The challenge of consistent design.

Beginning in October 2017 a system of basic hospital service provision, popularly called the 'hospitals network' was implemented in Poland. It covered 594 hospitals out of a total number of approx. 920 operating in 2017. The regulation's official objectives were to: "(1) improve the organization of services delivered by hospitals; (2) improve access to hospital care; (3) optimize the number of specialist wards; (4) improve coordination of in- and out-patient care; (5) facilitate hospital management". The aim of this paper is to describe the background of the reform planning and its formal objectives, content and implementation process, as well as to assess the preliminary results and discuss the possible limitations and implications. Although the official term 'hospitals network' is used to describe the reform, in practice it does not involve an element of cooperation between hospitals. The regulation's main feature was changing the financing methods for a pre-defined scope of services (from per-case to global budget).The reform was planned and implemented on a rather ad-hoc basis while its major controversy is the lack of quality of care, health outcome and population health need measures in the network inclusion criteria. The assessment of the reform's impact on service provision requires long-term analysis and access to detailed quantitative data.

Improving oncological care organization in Poland-The 2015 reform evaluation in the context of European experiences.

Cancer is one of the leading causes of morbidity and mortality worldwide with a significant economic impact which has been increasing in recent decades. Numerous expert groups and/or international organizations have developed guidelines on how to build effective cancer control mechanisms, while in the European Union the majority of countries have developed national programmes. In Poland, cancer is the second leading cause of death. Compared with other European countries, Poland is characterized by a relatively low cancer incidence ratio, yet in terms of mortality and survival ratios, the situation is much worse than the average. On 1 January 2015, an oncological therapy fast track was implemented in Poland, popularly known as the "oncological package." Its formal objectives were to improve access to and systemize the process of cancer diagnostics and treatment. The reform introduced some of the solutions existing in other European countries, including waiting time limits, patient pathways, multidisciplinary medical consultations, and a care coordinator position. The preliminary evaluation analyses suggest that after the reform implementation the average waiting time for diagnostics and treatment for patients covered by the new system was significantly shortened in comparison to those excluded. Further research evaluating the reform impact on quality and/or comprehensiveness of care are needed.

Poland: health system review

This analysis of the Polish health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. In late 2017, the Polish governmentcommitted to increase the share of public expenditures on health to 6% of GDP by 2024. If the GDP continues to grow in the years to come, this will present an opportunity to tackle mounting health challenges such as socioeconomicinequalities in health, high rates of obesity, rising burden of mental disorders and population ageing that put strain on health care resources. It is also an opportunity to tackle certain longstanding imbalances in the health sector, including overreliance on acute hospital care compared with other types of care, including ambulatory care and long-term care; shortages of human resources; the negligible role of health promotion and disease prevention vis-à-vis curative care; and poor financial situation in the hospital sector.Finally, the additional resources are much needed to implement important ongoing reforms, including the reform of primary care. The resources have to be spent wisely and waste should be minimized.The introduction, in 2016, of a special system (IOWISZ) of assessing investments in the health sector that require public financing (including from the EU funds) as well as the work undertaken by the Polish health technology assessment (HTA) agency (AOTMiT), which evaluates health technologies and publicly financed health policy programmes as well as sets prices of goods and services, should help ensure that these goals are achieved. Recent reforms, such as the ongoing reform of primary care that seeks to improvecoordination of care and the introduction of the hospital network, go in the right direction; however, a number of longstanding unresolved problems, such as hospital indebtedness, need to be tackled.

Reimbursement of Orphan Drugs in Europe in Relation to the Type of Authorization by the European Medicines Agency and the Decision Making Based on Health Technology Assessment.

Objective: To assess shares of reimbursed orphan drugs and agreement in reimbursement decision-making in different European Union member states as well as to define odds for reimbursement influenced by the presence of conditional approval or exceptional circumstances granted by the European Medicines Agency (EMA) or by type of the disease. Methods: The list of authorized drugs with current orphan designations was collected from the website of the EMA. For each drug, the information regarding conditional approval or approval under exceptional circumstances was collected. The reimbursement statuses were available on national reimbursement or HTA agencies websites. The agreement for reimbursement decisions between selected countries was assessed using the κ coefficient for the measurement of agreement. The impact of the EMA's conditional approval as well as approval under exceptional circumstances was assessed using the logistic regression and presented as odds ratio. Results: The percentage of reimbursed orphan drugs varied significantly from 27% in Poland to 88% in Denmark, with an average value of 51% (p < 0.0001). Regarding the reimbursement status, the highest, substantial agreement was observed between Spain and Italy, and the lowest agreement was observed between Germany and England, with κ of 0.64 and 0.01, respectively. Conditional approval status significantly decreased the chance for reimbursement in France, Italy, and Spain by 77-80%; however, approval granted under exceptional circumstances had significant impact only in Germany with 85% decrease in chances for reimbursement. The type of the disease (oncology or metabolic) was significantly associated with both conditional approval (p of 0.03-oncology drugs were more likely to be conditionally approved then the rest of analyzed drugs) and exceptional circumstances (p of 0.02-drugs for metabolic diseases were more likely to be approved under exceptional circumstances). Conclusions: Access to reimbursed orphan drugs varies significantly across EU countries. The highest, substantial agreement in reimbursement decisions was observed between Italy and Spain and the lowest between Germany and England. Conditional approval and approval under exceptional circumstances were significant negative predictors of reimbursement in some countries and they were significantly associated with the type of the disease (oncology or metabolic).

Building hospital capacity planning mechanisms in Poland: The impact of 2016/2017 regulatory changes.

Capacity planning is a crucial component of modern health care governance. The aim of this paper is to analyze the requirements that need to be met to build effective hospital capacity planning mechanisms in Poland. In this context, the recent regulatory changes strongly influencing hospital sector functioning, including introduction of health care needs maps, capital investment assessment, and hospital network regulations, are analyzed. Some possible ways forward, based on review of international experiences in hospital capacity planning, are discussed. Applied methods include literature review and analysis of statistical data as well as desk analysis of key national regulations related to hospital sector. Results indicate that at the system level, the process of capacity planning involves 4 elements: capital investment in facilities, equipment, and technology; service delivery; allocation of staff; and financial resources. For hospital capacity planning to be effective, the strategic decision at the macrolevel must be complemented by appropriate management of individual hospitals. The major challenge of building hospital capacity planning mechanism in Poland is imbedding it into the overall health system strategy. Because of the lack of such a strategy, the practical implementation of the ad hoc changes, which have been introduced, shows some inconsistencies. The regulations implemented between 2016 and 2017 provided a basis for hospital capacity planning, yet still need evaluation and adjustments. Also, including a mechanism for human resources planning is of crucial importance. The regulations should provide incentives for reducing oversized hospital infrastructure with simultaneous development of the long-term and coordinated care models.

Pharmaceutical Regulation in Central and Eastern European Countries: A Current Review.

Objectives: The aim of this study was to review reimbursement environment as well as pricing and reimbursement requirements for drugs in selected Central and Eastern Europe (CEE) countries. Methods: A questionnaire-based survey was performed in the period from November 2016 to March 2017 among experts involved in reimbursement matters from CEE countries: Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovakia, and Romania. A review of requirements for reimbursement and implications of Health Technology Assessment (HTA) was performed to compare the issues in above-mentioned countries. For each specified country, data for reimbursement costs, total pharmaceutical budget, and total public health care budget in the years 2014 and 2015 were also collected. Questionnaires were distributed via emails and feedback data were obtained in the same way. Additional questions, if any, were also submitted to respondents by email. Pricing and reimbursement data were valid for March 2017. Results: The survey revealed that the relation of drug reimbursement costs to total public healthcare spending ranged from 0.12 to 0.21 in the year 2014 and 2015 (median value). It also revealed that pricing criteria for drugs, employed in the CEE countries, were quite similar. External reference pricing as well as internal reference pricing were common in mentioned countries. Positive reimbursement lists were valid in all countries of the CEE region, negative ones were rarely used; reimbursement decisions were regularly revised and updated in the majority of countries. Copayment was common and available levels of reimbursement differed within and between the countries and ranged from 20 to 100%. Risk-sharing schemes were often in use, especially in the case of innovative, expensive drugs. Generic substitution was also possible in all analyzed CEE countries, while some made it mandatory. HTA was carried out in almost all of the considered CEE countries and HTA dossier was obligatory for submitting a pricing and reimbursement application. Conclusions: Pricing and reimbursement requirements are quite similar in the CEE region although some differences were identified. HTA evaluations are commonly used in considered countries.