Prof. Dr. started with a rather harsh criticism of health care research. Karl Lauterbach (SPD parliamentary group) presented the first block “Quality orientation from the perspective of politics and self-administration” of the MVF congress “Quality 2015”. With the words “very good ideas, no good methodology” he summed up the dilemma of German health services research, which could leave this critical approach behind once and for all in the wake of the upcoming innovation fund. But there is still a lot to do until then, as Prof. Dr. Matthias Schrappe (University of Cologne) explained in his “Lecture on Quality 2030 – From Measuring to Controlling”, who compared German quality assurance efforts with Michael Ende’s pseudo-giant “Tur Tur”: the closer it gets, the smaller it becomes.

> In Lauterbach's view (see p. 20 f.), cost-benefit analysis and here QALY-oriented methodology will “rightly experience a renaissance” - starting from the field of oncology. Although this method, which is now relatively well standardized and easy to implement, has fallen into disrepute to some extent in recent years, the SPD health politician, who gave a more scientific lecture at the MVF congress, sees it as a very interesting, important and also a lot tougher methodology than is used in many other areas of economics. Lauterbach: “For example, if I compare the environmental-economic studies with the classic cost-benefit analysis, in the medical field the outcomes and also the costs are much easier to standardize and measure.”
This analysis therefore enjoys a very good reputation within economics, but not yet in health care research and medicine. “But that will change,” predicts the politician, because Germany is also moving more and more into the area in which important decisions have to be made. Lauterbach: “Even if in Germany there will never be a cut-off line like in the English system, beyond which a service will no longer be reimbursed – never!”

Klakow-Franck: “a political decision-making process”

Before there can be an approach to the Anglo-Saxon QALY system in Germany, there is still a lot of other homework to be done - for example, quality-oriented requirements and remuneration planning, a dream child of Federal Health Minister Hermann Gröhe. “Looking back, I find the combination of quality assurance and fee schedule to be an enrichment,” explained Dr. Regina Klakow-Franck, impartial member of the Federal Joint Committee, added: “Because the link between money and quality makes it a little easier to approach the issue of quality premiums and discounts.” As an officially indirect state administration and sub-statutory standard setter, the G -BA to bring about a balance of interests between the cost bearers and the service providers through the guidelines it has issued - including quality requirements. Although the G-BA tries to scientifically base its decisions and guidelines, Klakow-Frank knows very well: “Ultimately, their coming about is to a large extent a political decision-making process.”
In this context, the federal-state working group has assigned many new tasks to the Federal Committee in connection with the upcoming hospital reform, which are to be implemented quickly from next year with the help of the new Institute for Quality Assurance and Transparency in Health Care (IQTiG) and the IQWIG. However, this requires indicators relevant to planning and remuneration, which, from the G-BA's point of view, are “excessive and overloaded in their political expectations”.
One component of the hospital reform is the quality-oriented further development of hospital planning, which, according to Klakow-Franck, must in turn be accompanied by a further development of the entire remuneration system and the targeted reduction of the shortage of skilled workers in nursing. What is important, however, is: “The quality-oriented further development of hospital planning, as important as this detail is in principle, is only one building block in an overall concert that has to work together if something is actually to change.” In this concert, the G-BA is now assigned a number of tasks which are already foreseeable from the key points of the federal-state working group. On the one hand, with the help of the new quality institute IQTiG, not only indicators relevant to planning are to be developed, but also sanction regulations for under-documentation are to be issued, specifications for security surcharges are to be developed and a tiered system for emergency care is to be defined. Furthermore, as Klakow-Franck emphasized, the G-BA should, as Klakow-Franck emphasized, set minimum requirements for structural, process and result qualities in guidelines and develop criteria for a test procedure to be carried out by the MDK with which compliance with the minimum requirements can be ensured in the future should be checked. Furthermore, the Federal Committee should use the minimum quantity instrument and also launch a second group of indicators, which will also include quality surcharges and discounts, develop plannable services for quality-oriented selective contracts and the second opinion procedure and finally further develop the quality reports so that they are more than before can actually be used by the insured. Klakow-Franck, impartial member of the G-BA: “So a whole lot of work, of which the planning-relevant indicators are only a detailed point, even though the overarching goal has already been formulated very elegantly in the coalition agreement.” It is written there that Currently location-based hospital planning should be “further developed into accessibility-oriented care management”. Klakow-Franck: “That makes sense in principle, but it requires the development of new, planning-relevant quality indicators in the areas of structure, process and result quality.” But defining these is anything but easy, because on the basis of these quality indicators, if necessary Decisions about the inclusion or retention of a department or even an entire hospital in the hospital plan are made.
Since the discussions in the G-BA have not officially started yet, Klakow-Franck would like the following statements to be understood as very personal considerations. In her very personal opinion, the G-BA - and also the IQTIG - will only be able to move within the limits within which the G-BA is equipped with its standard-setting competence when developing the planning-relevant indicators. However, since the G-BA is bound to standardization limits, in their opinion the planning-relevant indicators to be developed must also deliver comparable results. Another major requirement is that these new indicators must be legally secure to a high degree because decisions may be linked to them - for example, whether a hospital or a specialist department is included in the hospital plan or not. On top of that, the whole thing has to be relevant to care, because ultimately care should be controlled and ultimately also evidence-based.
At this point, the G-BA and also the IQTIG, which will work on its behalf, will have to ensure that they only act within the scope of the G-BA's own competencies. According to Klakow-Franck's view, it must be clear to everyone that the Federal Joint Committee is "not responsible for planning and ensuring public services" - part of which is inpatient care - because that is "the sole responsibility of the states". The G-BA is exclusively responsible for setting minimum quality requirements - but that again at the facility level; I mean: valid in every single and for every single hospital. Klakow-Franck: “The G-BA will concentrate precisely on these planning-relevant quality indicators that are aimed at the individual facilities.” On the other hand, the G-BA is specifically required by case law in connection with the minimum quantities to carry out an impact assessment - particularly with regard to the effects of possible restrictions on supply in the region. According to Klakow-Franck, the G-BA will certainly have to look at this impact assessment “even more carefully than in the past”, and not only in connection with the minimum quantity regulations.
Apart from that, what is ultimately developed must produce comparable results. Klakow-Franck: “That may sound succinct, but the necessary risk adjustment using regression analyzes is anything but easy.” Of course, demographic factors such as age and gender, as well as clinical factors, would have to be taken into account in a risk adjustment, but there would also be comorbidities, socio-economic factors such as migration background and education as well as the health-related behavior of the insured. The problem with this is: “We will hardly be able to adequately represent this individual data with the existing social database, which we should preferably use.” In the previous development of the cross-sector quality assurance procedures, the G-BA has had to experience that a lot of necessary information is currently available cannot be derived from the social database even for risk adjustment purposes. The Federal Committee therefore welcomes the fact that the usability of social data should be promoted at the federal and state level, even if it will probably only be a data basis limited specifically for risk adjustment purposes.
Since the new planning-relevant indicators are intended to control inpatient care at the state level, they must be relevant to care. But, Klakow-Franck asks rhetorically: “Can we actually do that with our current stationary quality assurance indicators?” Her answer: “Probably not, because the previous set of indicators was originally developed for stationary quality assurance for benchmarking in a protected space.”
In addition, it tends to follow the tracer philosophy: For example, one only looks at the performance area of gallbladder removal as a representative of the entire area of visceral surgery and then extrapolates. In addition, for historical reasons, the previous set of indicators for hospital care is procedure-oriented, meaning it is related to operations, rather than diagnosis or morbidity-oriented. In addition, only very few sections would be illuminated, while other and often important areas would not be shown at all. Klakow-Franck: “This in turn means that this set of indicators can actually only contribute very little to regional, population-based and morbidity-oriented care management. But that is not the fault of this set of indicators or even of the entire quality concept, because it was originally developed for other purposes.”
Schrappe: No taxes without a goal
“Taxes without a goal are somehow a difficult thing,” replied Prof. Dr. Matthias Schrappe, University of Cologne, in his lecture “Quality 2030 – From measuring to controlling”, who, as a passionate sailor, knows exactly what he is talking about. His petition: “It is better to avoid any quality assurance and any quality improvement without knowledge of the goal.” It is not for nothing that he compares the “very energetic quality assurance efforts that are becoming endless” with the picture of Michael Ende's pseudo-giant “Tur Tur”. Schrappe: “If you look at our quality assurance from the outside, you say: my God, what we have.” But when you look closer at what he has been doing as a scientist for decades, your perspective changes, especially when you look at the currently popular “ Taxes instead of measurements”. This is mainly due to the lack of target definition, which is already expressed in the German terminology. While the English countries would call this “quality improvement”, the Germans would say “quality assurance”, a term that would already contain “defeat”. “We need a term like quality improvement at the system level,” demands Schrappe, because this nomenclature would encourage everyone involved to talk about improvement. And above all about benefits, as Prof. Dr. Franz Porzsolt from Ulm University Hospital emphasized in the subsequent panel and plenary discussion (see p. 25).
When it comes to quality assurance, quality management and the question of quality in general, Schrappe asks; “How do we manage to convert what is to be measured into an explicit value?” His answer: “By first and foremost becoming clear about the requirements.” That's exactly why Germany needs a discussion about goal orientation. And when you talk about hospital planning, the most pressing health problem is no longer the need to equip hospitals to treat acute illnesses, as it used to be, but rather that of an aging population with chronic multiple illnesses and an enormous need for coordination. Schrappe: “After we have considered whether we have a reasonable idea of goals, we need indicators for a quality improvement strategy that is not above addressing structural issues in our health system.” If Germany really has one If we wanted to make grounded policy, every indicator measured would have to have a potential in the direction of coordination and integration of our system. If these components were not made an object, they should at least resonate. Schrappe: “We should consider whether certain useless and unpleasant side effects of our compensation systems, such as the quantity incentive, could be partially positively replaced by a quality incentive.”
Schrappe, who outed himself as an “absolute fan of the Federal Joint Committee” as a sub-legal form of opinion formation, responded to Lauterbach's criticism by saying that politicians have often made things too easy for themselves in recent times. Namely, by delegating “everything very quickly in huge lists” to the G-BA, without having, however, politically defined the necessary strategic objectives beforehand.
Pfeifer: Quality must have consequences
One of these necessary political decisions is the one that Hans-Werner Pfeifer, National Association of Statutory Health Insurance Funds, took up from the perspective of the health insurance companies in his lecture “From quality assurance to quality control?” He is firmly convinced that “quality must finally have consequences” - not only for the quality of the structure, but also for the quality of the results. This paradigm shift alone will lead to a completely changed supply reality in the short term.
But there is still a long way to go before then. Or to get it out of the way. Because, according to Pfeifer, the federal and state governments initially only concentrated on the inpatient area, which had historical reasons. He considers the goal of adding quality to hospital planning and formulating the necessary indicators this year “to be very ambitious and actually not achievable”. At the same time, the evaluation process in structured dialogue should be significantly shortened; and the states should be given the opportunity to make this regulation part of hospital planning. Pfeifer's criticism: "The legislature is making the mistake of granting the states this option, but not making it mandatory, and the states are also given the opportunity to make regional regulations that deviate from this." The Federal Association sees this as a significant risk a regional reduction in quality requirements. “If a country has the opportunity to deviate from certain hard criteria, then there is a great temptation to do so,” says Pfeifer.
Compliance with the mandatory requirements in the form of quality assurance guidelines is extremely important for the central association of health insurance companies. “It can only be the case that non-compliance will of course result in reductions in remuneration and ultimately the withdrawal of billability,” says Pfeifer, who advocates for a reduction system. However, a step-by-step concept is needed, as there will be a gray area in which the assessment of the service provided causes difficulties. Pfeifer: “We find it very important and essential that the MDK is given significantly greater importance than it already has in terms of checking compliance with specifications and also checking documentation in the hospitals.” The check is also necessary the OPS complex codes. In Pfeifer's opinion, only then can the performance of the hospital be presented with the necessary transparency. Of course, the regulation cannot be made by the G-BA, but is a matter for the contractual partners at the federal level. But it remains to be seen whether the federal states will ultimately draw conclusions from the new findings gained in this way as part of hospital planning.
For example, the connection between quality and remuneration. As Pfeifer explained, implementation of the structural quality specifications, a large number of which have already been created in the G-BA, is already feasible today. But if quality has to be worth it, which is certainly undisputed, it would ultimately be difficult to convey if quality reductions were only made after a transition period of two years. But a discount cannot be the only solution. “Anyone who consistently provides poor quality and remains below a certain level of quality should be consistently excluded from providing services,” demands the Spibu representative, who ultimately assumes that “these measures will lead to the hospital market slowly but surely gradually cleaned up.” <<