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Over the last decades, methods for the economic evaluation of health care technologies were increasingly used to inform reimbursement decisions. For a short time, the German Statutory Health Insurance makes use of these methods to support reimbursement decisions on patented drugs. In this context, the discounting procedure emerges as a critical component of these methods, as discount rates can strongly affect the resulting incremental cost-effectiveness ratios. The aim of this paper is to identify the appropriate value of a social discount rate to be used by the German Statutory Health Insurance for the economic evaluation of health technologies. On theoretical grounds, we build on the widespread view of contemporary economists that the social rate of time preference (SRTP) is the adequate social discount rate. For quantifying the SRTP, we first apply the market behaviour approach, which assumes that the SRTP is reflected in observable market interest rates. As a second approach, we derive the SRTP from optimal growth theory by using the Ramsey equation. A major part of the paper is devoted to specify the parameters of this equation. Depending on various assumptions, our empirical findings result in the range of 1.75-4.2% for the SRTP. A reasonable base case discount rate for Germany, thus, would be about 3%. Furthermore, we deal with the much debated question whether a common discount rate for costs and health benefits or a lower rate for health should be applied in health economic evaluations. In the German social health insurance system, no exogenously fixed budget constraint does exist. When evaluating a new health technology, the health care decision maker is obliged to conduct an economic evaluation in order to examine whether there is an economically appropriate relation between the value of the health gains and the additional costs which are given by the value of the consumption losses due to the additional health care expenditures. Therefore, a discount rate lower than the SRTP for consumption should be applied if an increase in the consumption value of health is expected. However, given the limited empirical evidence on the relationship between consumption and the value of health, it is hardly possible to make reliable forecasts of this value. Regarding the practice of the German evaluation authority, it is not recommended to use differential discounting in the base case. Instead, the issue of differential discounting should be addressed in sensitivity analyses. Reducing the discount rate for health compared to the rate for costs by a figure in the range between near 0% and 3% may be considered to be appropriate for Germany.

The central tasks of health services research include the description and analysis of health care under everyday conditions as well as the development and evaluation of new concepts. As a first step, the reality of the health services' situation should be assessed using representative data. For that, registries, claims data of health insurance funds or observational studies are suitable. To investigate specific patterns or decisions, qualitative methods are of importance. To evaluate the effectiveness of health care concepts or structures, pragmatic randomized, controlled trials are considered to provide the best evidence. In this paper we discuss these questions on the basis of treatment for patients with small renal masses. Although recent guidelines recommend nephron-sparing surgery instead of radical nephrectomy for these patients, international studies suggest that there is a significant underuse of nephron-sparing procedures. However, national data describing the situation in Germany are necessary to analyse reasons and to develop new concepts which subsequently have to be tested in randomized trials. Therefore, the aim of health services research is to create a scientific basis for continuous improvements in health care. Urology needs health services research and we should find ways to overcome barriers to improve quality of care.

In Germany, health services research has become an important area of research. Health services research is a multidisciplinary field of scientific investigation that studies central problems of health care to increase knowledge and understanding and provide solutions for those problems. The paper aims to demonstrate the value of health services research for health care practitioners by defining its central tasks, by describing the development of this research field in Germany and by deriving future challenges for health services researchers.

The Federal Joint Committee (FJC; Gemeinsamer Bundesausschuss, G-BA) defines the health-care elements that are to be reimbursed by sickness funds. To define a directive, the FJC can commission benefit assessments, which provide an overview of the scientific evidence regarding the efficacy and benefits of an intervention. This paper describes the operational implementation of the legal requirements with regard to the benefit assessments of medicines. Such benefit assessments are sometimes referred to as "isolated benefit assessments," to distinguish them from benefit assessments as part of a full economic evaluation.The FJC has the freedom to commission these assessments from any agency; however, to date the majority have commissioned the Institute for Quality and Efficiency in Health Care (IQWiG). Nevertheless, the content of this paper applies integrally to any institute commissioned for such assessments. In this report, 'the institute' is used when the text refers to any of these institutes.The legal framework for benefit assessments is laid out in the German Social Code Book version V ( http://www.sozialgesetzbuch.de ), Sects. 35b ( section 1), 139a ( section 4-6) and Sect. 139b ( section 3). It is specified that: The institute must guarantee high transparency. The institute must provide appropriate participation of relevant parties for the commission-related development of assessments, and opportunity for comment on all important segments of the assessment procedure. The institute has to report on the progress and results of the work at regular intervals. The institute is held to giving the commission to external experts. Based on the legal framework, the institute must guarantee a high procedural transparency. Transparency of the whole process should be achieved, which is evidenced by clear reporting of procedures and criteria in all phases undertaken in the benefit assessment. The most important means of enhancing transparency are: 1. To implement a scoping process to support the development of the research question. 2. To separate the work of the external experts performing the evidence assessment from that of the institute formulating recommendations. Therefore, the preliminary report as produced by external experts needs to be public, and published separately from any subsequent amendments or (draft-)reports made by the institute, which includes the institute's recommendations. 3. To implement open peer review by publishing both the comments of the reviewers and their names. Based on the legal framework, the institute must provide for adequate participation of relevant parties. These include organisations representing the interests of patients; experts of medical, pharmaceutical and health economic science and practice; the professional organisations of pharmacists and pharmaceutical companies; and experts on alternative therapies. Patients and health care professionals bring in new insights with respect to research priorities, treatment and outcomes.The relevant parties should be identified and contacted whenever the global scope of the assessment has been drafted. Subsequently, the relevant parties should be involved in defining the research question, developing the protocol and commenting on the preliminary report. To implement the involvement of relevant parties in defining the research question a scoping process is suggested. For the other phases, written comments followed by an oral discussion should be used. Finally, the relevant parties should have the right to appeal the final decision on judicial grounds. None of these steps mean that the institute would lose any part of its scientific independence.From the relevant sections of the legal framework with respect to the assessment methods, it can be concluded that: 1. The institute must ensure that the assessment is made in accordance with internationally recognised standards of evidence-based medicine (EBM). 2. The assessment is conducted in comparison with other medicines and treatment forms under consideration of the additional therapeutic benefit for the patients. 3. The minimum criteria for assessing patient benefit are improvements in the state of health, shortening the duration of illness, extension of the duration of life, reduction of side effects and improvements in quality of life. EBM refers to the application of the best available evidence to answer a research question, which can inform questions about the care of patients. The optimal design, even for effectiveness questions, is not always the randomised, controlled trial (RCT) but depends on the research question and the outcomes of interest. To increase transparency for each question, the levels of evidence examined should be made explicit. There is no empirical evidence to support the use of cutoff points with respect to the number of studies before making recommendations. To get the best available evidence for the research question(s), all relevant evidence should be considered for each question, and the best available evidence should be used to answer the question. Separate levels of evidence may have to be used for each outcome.There are many ways in which bias can be introduced in systematic reviews. Some types of bias can be prevented, other types can only be reported and, for some, the influence of the bias can be investigated. Reviews must show that potential sources of bias have been dealt with adequately.Methods used by other agencies that perform benefit assessments are useful to interpret the term 'international standards' to which the institute must comply. The National Institute for Health and Clinical Excellence (NICE) is a good example in this respect. NICE shows that it is possible to have transparent procedures for benefit assessments but that this requires detailed documentation. NICE has implemented an open procedure with respect to the comments of reviewers, which makes the procedure transparent. Although the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany invites comments on their protocol and preliminary report by posting them on their website, and comments are made public, the individual comments are not evaluated openly, and therefore it remains uncertain whether or not they lead to changes in the reports. The participation of relevant parties in the assessment process as implemented by NICE guarantees a process that is transparent to all relevant parties.Transparency of the whole process is assured by clear reporting of procedures and criteria in all phases undertaken in the benefit assessment. In a scoping process, a draft scope is commented on first in writing and subsequently in the form of a scoping workshop. In this way, all relevant aspects can be heard and included in the final scope. The protocol is then developed, followed by evidence assessment. The methods used should be completely reported to show readers that the assessment has been performed with scientific rigour and that bias has been prevented where possible. All relevant parties should have the opportunity to comment on the draft protocol and the draft preliminary report. Each comment should be evaluated as to whether or not it will lead to changes, and both the comments and the evaluation should be made public to ensure transparency of this process. The same procedure should be used for the peer-review phase. Based on the final report of the evidence assessment, the institute forms recommendations and the FJC appraises the evidence.During the writing of the final report, a separation between the evidence assessment and the evidence-appraisal phase should be implemented. Ideally, this separation should be legally enforced to prevent any confusion about conflict of interests.Such a process guarantees a feasible combination of the legal requirements for transparency and involvement of relevant parties with international standards of EBM to ensure that the benefit assessments of medicines in Germany are performed according to the highest standards.

The aim of this methodological paper is to summarize evidence on how to implement cost-benefit assessment according to the new German legislative framework (Competition Enhancement Act). Given the complexity of existing health policy frameworks within industrialised countries in adapting health economics in their respective regulatory scheme, no clear international scientific consensus on which health economic methods should be chosen for assessment can be determined. Nevertheless, a broad consensus on the internal properties of methods itself can be found. Based on these common international standards in methodology, this work provides a minimum catalogue of methods and criteria that meet legal and local German requirements with regard to specific factors of its health care system. Aside from categorising clearly defined standards (e.g., study forms, cost and benefit categories) the suggested catalogue specifies some intensively debated areas in Germany (e.g., the QALY, modelling, the perspective used in the assessment). After the proposition of certain methods the paper leads to a first recommendation of a detailed assessment-process itself specific for the German way in implementing cost-benefit ratios within regulatory decision making in Germany.

Telepathology, defined as the practice of pathology over a distance by viewing images transmitted from a remote site, was previously analyzed mainly with respect to technical equipment and diagnostic accuracy compared with conventional histological diagnosis. In this paper, telepathology is analyzed with regard to economic points of view, demonstrating the background for the cost-saving analysis of telepathology. The acquisition cost and the operating costs of a telepathology system are compared with potential cost-saving and other benefits from telepathology. This analysis may help to decide whether or not telepathology should be established in a hospital.

With a system of modeling, simulation, animation of information, communication in medicine (mosaic-m) the structures of organisation and information in a level 1 trauma center were analysed and animated as a virtual environment on screen in a first step. One result: in existing paper orientated documentation 50% of documentation was redundant. In a second step the requirements of the future information system were described systematically, user- and organisation-oriented. All components (hard- and software) were simulated an screen that the user could work virtually in the future working place. With mosaic-m the user is fully integrated in analysing and developing a new information system in the clinic.

The legal "contract for patient care" issued by the Federal Government for all hospitals interferes with graduate medical education (approbation order), postgraduate surgical training, the KMK paper for new structures and financing of university medicine, health politics of the Physicians Parliament and the Legal Health System, guidelines for surgical practice, internal and external quality measurement, and, last but not least, with clinical research in surgery. The different effects are outlined in detail.