Allokationsethik im deutschen Gesundheitswesen: Zur Diskrepanz von Rationierungsrealität und Rationierungsdebatte in Deutschland

This paper takes a close look at the distributive principles of the German health system and analyses to what extent the highest standard of health care can still be ensured for all patients in Germany. The way in which the public rationing debate is being conducted and ethical issues are being addressed, highlights the necessity to distinguish between egalitarian and utilitarian approaches to the distribution of health care services. The terminology derived by making this distinction can then be used to analytically classify the rationing of health care services as well as the debate surrounding the issue within the context of german neocorporatism. Whilst there is already clear evidence of rationing in Germany, in the debate the exclusion of health care services is generally treated as something that will become relevant in the future. This apparent discrepancy between debate and reality is also mirrored by a rationing praxis, which at times contravenes the principles upon which a pluralistic society is based. This paper concludes with an attempt to define the democratic bounds within which justifiable restrictions to current health care services can conceivably be carried out.     

Rationing versus rationality: observations from outside the United States.

This commentary takes up A. David Paltiel's invitation to reflect on how to promote the use of decision analysis and cost-effectiveness analysis in health. From the perspective of a health services researcher outside the U.S. system, I make 3 arguments. First, the unthinking use of the term rationing for all applications of cost-effectiveness analysis distorts research priorities and may jeopardize wider public support. Second, public skepticism about decision and cost-effectiveness analysis (and thus the skepticism of decision makers) is well founded when ethical dimensions of these methods are not considered. We must continue to refine our methods to take account of societal values. Third, the United States may have particular problems in adopting more rational decision making in health care. The dominance of for-profit institutions in the U.S. health care system erodes the social legitimacy on which other systems depend to improve the rationality of health care decision making.     

The German strategy for quality improvement in health care: still to improve

One basic aim of German Health Policy is to secure a high quality of medical services financed by Statutory Health Insurance (SHI). Due to the specific relationships among patients, insurance funds and medical providers this aim is in a potential conflict with various cost-containment efforts introduced within the last 10 years. This article outlines a general theoretical framework to analyze the possible effects of these efforts on the quality of health care. It then analyzes the actual regulation approach strategy taken by German Health Policy for quality assurance in health care. Finally, it outlines a two-tier strategy based on regulation and competition as a means to ensure a high quality of care.     

Forum: rationing health care services. Introduction

Explicit rationing of health care is one of the most important issues under debate in the academic and political fields in both developed and developing countries. The articles presented in this Forum provide an approach to some of the questions relating to this issue. The approach is multidisciplinary, covering complex ethical questions and the contribution of economics to the debate. The analyses reveal specificities associated with the shift from implicit approach for rationing of health care, traditionally dominant in health systems, to a systematic and explicit priority-setting method in general and the potential incompatibility between efficiency and equity objectives in health policy in particular. The Forum's reflections link directly to current worldwide discussions on the questions "Why ration health care?" and "How to ration health care?"     

A Multi-Perspective Cost-Effectiveness Analysis Comparing Rivaroxaban with Enoxaparin Sodium for Thromboprophylaxis after Total Hip and Knee Replacement in the German Healthcare Setting

ABSTRACT: BACKGROUND: Patients undergoing major orthopaedic surgery (MOS), such as total hip (THR) or total knee replacement (TKR), are at high risk of developing venous thromboembolism (VTE). For thromboembolism prophylaxis, the oral anticoagulant rivaroxaban has recently been included in the German diagnosis related group (DRG) system. However, the cost-effectiveness of rivaroxaban is still unclear from both the German statutory health insurance (SHI) and the German hospital perspective. Objectives To assess the cost-effectiveness of rivaroxaban from the German statutory health insurance (SHI) perspective and to analyse financial incentives from the German hospital perspective. METHODS: Based on data from the RECORD trials and German cost data, a decision tree was built. The model was run for two settings (THR and TKR) and two perspectives (SHI and hospital) per setting. RESULTS: Prophylaxis with rivaroxaban reduces VTE events (0.02 events per person treated after TKR; 0.007 after THR) compared with enoxaparin. From the SHI perspective, prophylaxis with rivaroxaban after TKR is cost saving (E27.3 saving per patient treated). However, the costeffectiveness after THR (E17.8 cost per person) remains unclear because of stochastic uncertainty. From the hospital perspective, for given DRGs, the hospital profit will decrease through the use of rivaroxaban by E20.6 (TKR) and E31.8 (THR) per case respectively. CONCLUSIONS: Based on our findings, including rivaroxaban for reimbursement in the German DRG system seems reasonable. Yet, adequate incentives for German hospitals to use rivaroxaban are still lacking.     

QALYs and ethics: A health economist's perspective

Objectors on ethical grounds to the use of QALYs in priority-setting in public health care systems are here categorised as (1) those who reject all collective priority-setting as unethical; (2) those who accept the need for collective priority-setting but believe that it is contrary to medical ethics; (3) those who accept the need for collective priority-setting and do not believe that it is contrary to medical ethics, but reject the role of QALYs in it on other ethical grounds; and (4) those who accept the need for collective priority-setting in principle, but are unwilling to specify how it should be done in practice. It is argued that the first two groups of objectors are simply wrong, if distributive justice is a proper ethical concern in this context. The third group is of more interest, as this group appears to believe that QALYs are unethical because it is unethical to regard QALY maximisation as the sole objective of the health care system. This paper argues that QALYs are relevant to a much wider range of objectives than QALY maximisation, and that they can accommodate a wide variety of health dimensions and sources of valuation. They can also accommodate the differential weighting of benefits according to who gets them, so they do not commit their users to any particular notion of distributive justice. What they do commit their users to is the notion that the health of people is a central concept in priority-setting, and that it is desirable, for reasons of accountability, to have the bases for such priority-setting made as precise and explicit as possible. The fourth group of objectors needs to acknowledge that there is no perfect system on offer, and since priority-setting does and will proceed willy-nilly we cannot wait until there is. It would be more constructive to set up the desiderata that a priority-setting system should ideally fulfil, and then appraise all feasible alternatives (including the status quo) even-handedly by those criteria. None will be perfect, but this author predicts that QALYs would emerge from such an appraisal with a significant role to play.     

Rationing health care services: an inherent issue

Limited resources in the health sector force a process of choice between alternative health care programs and services and patients or groups of patients who will receive care. In the absence of a price mechanism, the priority-setting process serves to allocate scarce resources among competing uses, and is thus a form of rationing. Traditionally, implicit approaches have dominated the health sector's decision-making, mostly by physicians. However, in the face of increasing budget constraints and rising patient expectations, more explicit and socially acceptable priority-setting practices are needed. Internationally, the development of explicit prioritization has proven difficult and controversial.     

Demografischer Wandel und Notwendigkeit der Priorisierung im Gesundheitswesen

The German health care system will face major challenges in the near future. Progress in medicine as well as demographic change will combine to drastically exacerbate the scarcity of resources in the health care system. The word scarcity in this case not only refers to the availability of funds. Other resources, e.g., staff, attention, time, and organs for transplantation, are also becoming scarce. It is conceivable that, in the future, it will no longer be possible to provide medical services for all patients to the same extent as in the past. If the necessary resources are not available in the health care system, if the potential for saving resources has been more or less exhausted, and if rationing shall not be an option, the only option to resort to will be prioritization. Prioritization in the health care sector denotes a supply of services according to specific, predetermined criteria. A broad and open public debate, which would have to be accompanied as well as moderated by the Health Council (“Gesundheitsrat”), is essential for determining such criteria.     

Primary Care Groups and NHS Rationing: Implications of the Child B Case

Implementing The new NHS and the 1997 NHS (Primary Care) Act will gradually extend cash-limiting into primary health care, especially general practice. UK policy-makers have avoided providing clear, unambivalent direction about how to 'ration' NHS resources. The 'Child B' case became an epitome of public debate about NHS rationing. Among many other decision-making processes which occurred, Cambridge and Huntingdon Health Authority applied an ethical code to this rationing decision. Using new data this paper analyses the rationing criteria NHS managers and clinicians used at local level in the Child B case; and the organisational structures which confronted them with such decisions. Primary Care Groups are likely to confront similar rationing decisions in respect of 'gate-kept' NHS services. However, such rationing processes are not so easily transposed to open-access services such as general practice. NHS rationing decisions, especially in PCGs, will require a much more specific ethical code than hitherto used. This revised version was published online in July 2006 with corrections to the Cover Date.     

Social health insurance in Nepal: A health system departure toward the universal health coverage

The World Health Organization has identified universal health coverage (UHC) as a key approach in reducing equity gaps in a country, and the social health insurance (SHI) has been recommended as an important strategy toward it. This article aims to analyze the design, expected benefits and challenges of realizing the goals of UHC through the recently launched SHI in Nepal. On top of the earlier free health‐care policy and several other vertical schemes, the SHI scheme was implemented in 2016 and has reached population coverage of 5% in the implemented districts in just within a year of implementation. However, to achieve UHC in Nepal, in addition to operationalizing the scheme, several other requirements must be dealt simultaneously such as efficient health‐care delivery system, adequate human resources for health, a strong information system, improved transparency and accountability, and a balanced mix of the preventive, health promotion, curative, and rehabilitative services including actions to address the social determinants of health. The article notes that strong political commitment and persistent efforts are the key lessons learnt from countries achieving progressive UHC through SHI.     

Multicriteria Decision Analysis for Including Health Interventions in the Universal Health Coverage Benefit Package in Thailand

ObjectivesConsidering rising health expenditure on the one hand and increasing public expectations on the other hand, there is a need for explicit health care rationing to secure public acceptance of coverage decisions of health interventions. The National Health Security Office, the institute managing the Universal Coverage Scheme in Thailand, recently called for more rational, transparent, and fair decisions on the public reimbursement of health interventions. This article describes the application of multicriteria decision analysis (MCDA) to guide the coverage decisions on including health interventions in the Universal Coverage Scheme health benefit package in the period 2009–2010.MethodsWe described the MCDA priority-setting process through participatory observation and evaluated the rational, transparency, and fairness of the priority-setting process against the accountability for reasonableness framework.ResultsThe MCDA was applied in four steps: 1) 17 interventions were nominated for assessment; 2) nine interventions were selected for further quantitative assessment on the basis of the following criteria: size of population affected by disease, severity of disease, effectiveness of health intervention, variation in practice, economic impact on household expenditure, and equity and social implications; 3) these interventions were then assessed in terms of cost-effectiveness and budget impact; and 4) decision makers qualitatively appraised, deliberated, and reached consensus on which interventions should be adopted in the package.ConclusionThis project was carried out in a real-world context and has considerably contributed to the rational, transparent, and fair priority-setting process through the application of MCDA. Although the present project has applied MCDA in the Thai context, MCDA is adaptable to other settings.     

Health care technology in the Federal Republic of Germany

The basic goal of the German health care system is equal access to all medical services for all citizens. The federal government sets the legal framework for the system, but most health policy decisions are made through bargaining between large organizations within a legal framework. The federal government took little active role in health care until the early 1990s, when it became increasingly apparent that budgeting and other cost containment measures seemed to be insufficient to successfully reduce the growth of mandatory sickness funds expenditures. A 1993 law has attempted to address some of the most obvious deficiencies in the system, while encouraging a market-oriented approach to health care. Health care technology assessment has almost no role in the German health care system. Attempts by professionals and politicians to introduce technology assessment into the health care arena have been largely unsuccessful.     

Gesundheit und Gerechtigkeit

The paper discusses issues of justice related to health and illness. The special normative status of health is justified based on Norman Daniels' theory of just health. As the health status of individuals is not only determined by access to health care services, the relationship between social inequalities and health status is described empirically and evaluated from an ethical perspective. There are good ethical and conomical reasons against a purely market driven organization of the health care system. As a result we have to answer the question how we can deal with the increasing scarcity of health care resources. Three strategies are presented and ethically evaluated: (1) Increase efficiency ("rationalization"), (2) increase available resources and (3) limit access to services ("rationing"). Especially the pros and cons of implicit vs. explicit ways to limit services are discussed. Finally, the procedural and material ethical criteria for the just distribution of scarce health care resources are presented.     

Correction to: A systematic review of economic evaluations of enzyme replacement therapy in Lysosomal storage diseases

In December 2019, the Digital Health Care Act (“Digitale-Versorgung-Gesetz”) introduced a general entitlement to the provision and reimbursement of digital health applications (DiGA) for insured persons in the German statutory health insurance. As establishing a new digital service area within the solidarity-based insurance system implies several administrative and regulatory challenges, this paper aims to describe the legal framework for DiGA market access and pricing as well as the status quo of the DiGA market. Furthermore, we provide a basic approach to deriving value-based DiGA prices. To become eligible for reimbursement, the Federal Institute for Drugs and Medical Devices evaluates the compliance of a DiGA with general requirements (e.g., safety and data protection) and its positive healthcare effects (i.e., medical benefit or improvements of care structure and processes) in a fast-track process. Manufacturers may provide evidence for the benefits of their DiGA either directly with the application for the fast-track process or generate it during a trial phase that includes temporary reimbursement. After one year of \]reimbursement, the freely-set manufacturer price is replaced by a price negotiated between the National Association of Statutory Health Insurance Funds and the manufacturer. By February 2022, 30 DiGA had successfully completed the fast-track process. 73% make use of the trial phase and have not yet proven their benefit. Given this dynamic growth of the DiGA market and the low minimum evidence standards, fair pricing remains the central point of contention. The regulatory framework makes the patient-relevant benefits of a DiGA a pricing criterion to be considered in particular. Yet, it does not indicate how the benefits of a DiGA should be translated into a reasonable price. Our evidence-based approach to value-based DiGA pricing approximates the SHI’s willingness to pay by the average cost-effectiveness of one or more established therapy in a field of indication and furthermore considers the positive healthcare effects of a DiGA. The proposed approach can be fitted into DiGA pricing processes under the given regulatory framework and can provide objective guidance for price negotiations. However, it is only one piece of the pricing puzzle, and numerous methodological and procedural issues related to DiGA pricing are still open. Thus, it remains to be seen to what extent DiGA prices will follow the premise of value-based pricing.     

Health Technology Assessment (HTA), evidenzbasierte Medizin (EbM) Alter Wein in neuen Schläuchen?

Health Technology Assessment (HTA) defines the systematic analysis of short and long-term consequences of the application of medical technologies with the aim of supporting decisions in policy-making and practice. The aim of directly supporting decision-making at a political level is the major difference to evidence-based medicine and guideline development. In Germany, HTA is being established only since the nineties. In this period, however, important steps for a permanent establishment of HTA in the German health service have been undertaken. One of these steps was the German HTA project, which was funded from 1995 to 2001 by the Federal Ministry of Health. Beginning in 2001, this initiative will be relaunched by the German Institute for Medical Documentation and Information (DIMDI) as a regular HTA program. The bodies managing the German health care system rely increasingly on HTA reports when deciding on coverage of health technologies. HTA thus proves to be an instrument, which could be of benefit in the optimisation of the health care system.     

HTA in den Entscheidungsprozessen des IQWiG und G-BA

The development of the German HTA system and the corresponding HTA law began in 2000 and was concluded for the time being with the coming into force of the law on the modernisation of statutory health insurance on 1 January 2004. This law has established the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) as "new institutions" of statutory health insurance, restructured the procedures for the assessment of health services and formulated more precise assessment criteria than hitherto provided. There are other institutions in the health care system concerned with HTA which are not dealt with here.     

Health impact assessment of building and investment projects

For regional planning and approval procedures for building projects of a certain order of magnitude and power rating according to the German Federal Act on the Prevention of Emissions with Integrated Environmental Impact Assessment (EIA), the German public health departments, acting as public authorities, increasingly perform health impact assessments (HIA). The amended Act on Environmental Impact Assessment, the Decree on industrial plants which require approval (4th Federal Decree on Emission Prevention) and the Health Service Acts of the Federal States of Germany form the legal basis for the assessment of health issues with regard to approval procedures for building and investment projects. In the framework of the "Action Programme for the Environment and Health", the present article aims at making this process binding and to ensure responsibility and general involvement of the Public Health departments in all German Federal States. Future criteria, basic principles and procedures for single-case testing as well as assessment standards should meet these requirements. The Federal Ministry for the Environment and the Federal Ministry for Health should agree on Health Impact Assessment (HIA ) as well as on the relaxant stipulations in their procedures and general administrative regulations for implementing the Environmental Impact Assessment Act (EIA). Current EIA procedures focus on urban development and road construction, industrial investment projects, intensive animal husbandry plants, waste incineration plants, and wind energy farms. This paper illustrates examples meeting with varying degrees of public acceptance. However, being involved in the regional planning procedure for the project "Extension of the federal motorway A 14 from Magdeburg to Schwerin", the Public Health Service also shares global responsibility for health and climate protection. Demands for shortest routing conflict with objectives of environmental protection which should be given long-term consideration. Assessing the direct impact of projects on human beings should be rank first in the list of priorities. The Hygiene Institute supports the efforts of the Public Health departments by providing professional consultant services to ensure consistency in the application of procedures.