>> According to the OECD indicators 2017 [OECD, 2017], Germany is in third place with 11.3 % of gross domestic product (GDP), behind the USA (17.2%) and Switzerland (12.4%). If you only look at contributions and tax money, Germany is in first place. When it comes to the number of hospital beds, a key cost factor, Germany is in fourth place (out of 43) with 8.1 beds per 1,000 inhabitants, behind Japan, Korea and Russia.
The picture changes when it comes to the results: these resources do not always put Germany in the top positions. What is striking in the OECD report is, among other things, high rates of thrombosis and embolism (419 and 340 in 100,000 procedures, respectively) after hip and knee procedures.
In a study that is based on the health burden and calculates an index for access and quality of care, Germany only ranks 20th out of 50 [GBD 2015]. The results for Germany were also unfavorable for epilepsy, testicular cancer, drug side effects and stomach ulcers. When it comes to the state of health perceived by citizens, Germany is well behind in 25th place (out of 34) with 64.5% positive answers “good or very good”. This impression varies with the level of citizens' income between 78% (high income) and 50.5% (low income) [OECD, 2017].
Over the years, attitudes (expansion of supply, economics, bureaucracy) and procedures (guidelines, regulations, bundles of laws) have gained space that not only hinder, but even block future-oriented development. Our health system, with a gross added value of 370 billion euros [BMG, 2019], urgently needs care goals and values that can be used to guide service design. Since these have not yet been explicitly defined, it is not possible to assess how good the health system really is. Does it achieve what it could really achieve with its extensive resources? The Advisory Council on Healthcare has been criticizing the relationship between effort and impact in its reports for more than ten years [SVR, 2018].
In this sense, Bismarck's great achievement from 1883 [Reichstag, 1883] has acquired some patina and should urgently be adapted to current requirements and available options. Binding target definitions are urgent and have been repeatedly recommended by the Council of Experts. Responsibility for results should be clearly assigned based on these goals. Goal achievement and resource consumption must be presented in a timely manner that is understandable and transparent for all citizens.
Numerous current initiatives by the BMG and other health system institutions are aimed in this direction. The salu.TOP concept offers an orientation framework for a comprehensive realignment of the healthcare system.
Realignment on the
Basis salu.TOP
Realignment of the healthcare system means that elements for which there is a broad consensus are functionally and logically linked via a set of rules. The essential elements of this realignment can be found in Table 1.
The concept for the realignment (salu.TOP) is characterized by the following key elements:
1. Orientations,
2. goals and values,
3. responsibility,
4. needs,
5. Compensation and efficiency
6. transparency,
7. Digitalization

salu.TOP contains some assumptions that are currently (still) firmly anchored in the system. Some partners in the system would almost present it as a call for a socialist revolution if the following provisions were questioned: sectoral structure, federal decision-making authority over the content of care, dual financing of hospitals, mixed financing from statutory and private health insurance with subsidies from taxpayers' money, a gag-like DRG system, high remuneration for technical and operational-curative measures, lack of transparency of the resources used and the results achieved, economization of care, to name just a few. The list could be continued for a long time. All of this is not new and has been critically presented in the past and regularly by the Council of Experts and reports from various foundations.
Parts are continued here as a firm assumption, not because this is good and right - quite the opposite - but because the persisting forces are so great. The assumptions cannot really be justified objectively. However, the salu.TOP rules show that these assumptions generally lead to contradictions and should actually be eliminated.

Orientations
Salu.TOP is based on the care needs of the population, the medical options, the scientifically accepted principles and the available resources. The distinguishing feature is always patient and benefit orientation. These orientations are supplemented by socially set norms. Technical developments, such as the expected digital platform for the healthcare system or the health apps that can now even be prescribed, are developed based on goals and evidence, scientifically evaluated and used taking all patients' rights into account.
Salu.TOP uses the competence, commitment and swarm intelligence of everyone involved for the benefit of citizens and patients. Targetless bureaucracy and corporatist paternalism have no place in the new system. Citizens finance the system. As patients, they are neither supplicants nor objects; rather, they have a legal right to efficient and good care. However, these rights according to §§ 12 and 70 SGB V are implemented rather patchily; financial aspects are too often in the foreground - income for DKG and KBV as well as costs for GKV-SV (treatment order).

Goals and values
Nationwide health and care goals are defined first and with the highest priority. Goals are always formulated “smartly” (specific, measurable, attractive, relevant and time-bound). The top rule is: “The BMG has patient and needs-oriented care goals developed for the entire population. These are based on a social consensus process, affect at least 90% of the supply volume and will be published during this legislative period.
For implementation in salu.TOP, the care goals and responsibilities are clearly regulated. Medicine and nursing content is based on reliable scientific evidence.
The care goals are accompanied by framework conditions and ethical standards. The self-organization in the health system regulates which processes are used to achieve goals and take values into account in the concrete implementation. Results must be presented in a timely, comprehensive and understandably transparent manner.
The new healthcare system salu.TOP has the main purpose of caring for patients. Citizens, taxpayers and insured persons provide all the resources. In this sense, they “own” the system. Health systems are also important economic factors. Making a profit is possible, but it is always subordinate to the purpose and the patient's well-being.

Responsibility
Responsibility through delegation
As a basis for implementation, rules are proposed on the basis of which salu.TOP can be developed. The desired health system uses our country's strengths, gives citizens the best opportunities for their health and protects them from undesirable developments. These rules take into account some requirements that were initially assumed to be unchangeable, such as a vertical structure into five levels, a federally oriented implementation and a sectoral structure of self-government. Of course, further optimizations would also be conceivable. This means that sectorization should be able to be overcome unconditionally and promptly.
The five levels of the health system are structured according to their functions and are operationally linked (Table 2).
Three rules are formulated for each level: Z1 to Z3, S1 to S3, ... P1 to P3. These hierarchically structured functional levels shape the salu.TOP health system with their rules, framework conditions and ethical requirements.

Responsibility through self-organization
In level 1 “Setting goals” the principles according to which the salu.TOP health system is designed are defined. Health policy initiates the process of defining the goals and provides the necessary resources. The goals themselves are developed with broad social consensus. Politics and citizens work closely together. This process must be kept free of special or political interests.
Level 2 “Self-organization” is functionally oriented, stands for “Organizing the system itself” and replaces the outdated term “self-management”. In salu.TOP, health care is self-organized and not managed in a goal- and patient-oriented manner.
At the top of this level is an institution that can handle the complex tasks of designing and managing the health system. This could be a further development of the GB-A. However, this “New GB-A” must be independent of the partial interests of the previous self-government bodies. Rather, these organs work together under his leadership in a constructive and patient-oriented manner. In doing so, they are committed to the care goals and the standards that accompany them.
Currently, the existing self-government bodies are required by statute to represent the interests of their members. This forced situation prevents them from constructively and innovatively designing a new, future-proof and patient-oriented healthcare system. With the new orientation, they can contribute in a targeted manner with their high level of expertise in their respective areas. It is obvious that a system as complex as our healthcare system cannot be led into the future with guidelines and structural laws.
The new institution at the forefront of self-organization will have low-threshold access to scientific competence and valid facts. At the forefront are scientific societies and institutions from areas such as medicine, epidemiology, medical sociology, health management, health services research, health economics, population demography, health reporting and statistics.
At level 3 “Regionalization”, the content specifications such as treatment paths from level 2 are adapted to the different geopolitical conditions in the regions. The main task is to derive organizational supply chains from the content-oriented treatment paths in such a way that equivalent living conditions are ensured despite large regional differences. At this level, the federal and municipal institutions work together with the structures of GKV, DKG and KBV. The state health ministries are responsible for the orientation and implementation.
Even in level 4 “Organize”, the service providers in practices, MVZs and clinics have all the options to organize care themselves, as long as they adhere to the relevant requirements: treatment paths, supply chain, evidence base, patient orientation, framework conditions and ethical standards and principles. In level 5 “Treatment” the primacy of patient co-decision and the principle that the benefit must always be greater than the harm are added as guidelines for treatment.

needs
The need to align the health system with the care needs of the population is undisputed. In several reports, the Advisory Council on Health Care has pointed out the need to align the health system with needs and not with supply; most recently in the report “Needs-based management of health care” [SVR, 2018].
The fact that it is possible to determine needs in the area of outpatient care is proven by a report from the G-BA 2018 “Expert report on the further development of needs planning within the meaning of Sections 99 ff. SGB V to ensure statutory health care” [GB-A, 2018]. For the stationary sector, the current report from the Bertelsmann Foundation [Loos et al., 2019] shows ways in which quality, efficiency and proximity to the citizen can be combined in accordance with Section 70 SGB V “Quality, Humanity and Economic Efficiency”. Methods and results for estimating structural needs in inpatient care are presented for a model region.
Compensation and efficiency
The core of the salu.TOP system is the comprehensible, goal- and needs-oriented connection of tasks and resources. Epidemiologically based care needs, goals and purposes are defined in a binding and transparent manner at level 1 “setting goals” and level 2 “self-organization”. They form the basis for allocating funds to health care facilities. The funds are no longer allocated to the sectors across the board, but rather the remuneration follows the services within the supply chains. Since the type and scope of the services follow the care needs and are assigned to the facilities via the treatment chains according to their performance, all measures to limit services upwards (expansion of cases) and downwards (minimum quantities) are unnecessary. The use of funds is regularly evaluated and presented transparently in the interests of allocative efficiency based on the appropriateness of the type and quantity of services as well as their quality. The quality is based on the planning-relevant IQTiG quality indicators associated with the treatment chains.

transparency
The technical support of documentation and communication using means and methods of modern information technology is structured and secured by the legally required standardization of documentation and interoperability between all those involved. This forms the data basis for level-specific health reporting on goals, tasks, responsibility, goal achievement, quality and resource consumption.
This means that health services research finds a valuable basis to, on the one hand, support decision-making at levels 1 and 2 and, on the other hand, to give those responsible for action at levels 3 and 4 a factual basis on which they can continuously optimize their service provision. Further scientific evaluations in the fields of epidemiology, health economics, care and quality management can also be carried out on this data basis.
The results of all evaluations are published promptly and in an understandable manner.

Digital transformation
For IT-based communication in integrative treatment chains and for evaluation in the sense of modern health reporting, an interoperable technology platform with binding specifications must be created.
The options available as part of the digital transformation must be checked for benefits, risks, side effects and contraindications before their introduction using health services research methods, in accordance with the procedure for drug testing. Using health economics methods, costs and benefits must be weighed up. In the area of self-organization, a decision is made about admission.
The rules and their implementation
The rules were derived from the bottom up based on the relationship between patients and practitioners in level 5 “Treatment”. The derivation begins with the rule “The patient decides what happens”. What was characteristic of level 4 “Organizing” was the organizational context in which the facilities work together to provide integrative care. Regional peculiarities were identified and taken into account in level 3 “Regionalization”. Here the regional self-organization bodies work together under the supervision of the state health ministries. Crucial foundations for the content and organization of health care are created in level 2 “Organize the system”. At this level, a crucial obstacle to future-oriented development is removed: the work of the current Federal Joint Committee is often hampered by irresolvable conflicting goals between the “benches” (“dead lock”). This deadlock, which cannot be solved by the statutes of the bodies, is resolved through a clear, goal-oriented work assignment to the “self-organization” level. In level 1, “Setting goals,” binding health and care goals as well as additional standards are created.
For implementation, the set of rules is linked to the framework conditions and ethical standards. The implementation starts top-down at level 1 “Setting goals” with the definition of the care goals (rule G1). The tasks of health policy are limited to enabling the development of goals as well as framework conditions and ethical standards and ensuring the provision of resources. A delegation procedure plays a key role in implementation. This means that the responsibility for operationalizing and implementing the goals and values is formally and structured transferred to Level 2 “Organize the system itself”.
It becomes clear that the “Joint Federal Committee” in its current form was not designed to handle such tasks. The “dead lock” in which the organs of previous self-government have found themselves will be lifted by the redefinition of an institution at the top of level 2 “self-organization”. This “New G-BA” develops the content, scope and type of care with comprehensive scientific support. It is based on the care needs, the available evidence and the available resources. Framework conditions and ethical requirements are binding cornerstones.
The existing bodies are thus released from definitional obligations, but are given comprehensive implementation tasks. In addition, their implicit conflict of objectives between the statutory tasks of representing the interests of their members and the constructive participation in the design of the health system as a whole is resolved. The patient's well-being always takes precedence over the interests of the members of GKV-SV, DKG and KBV. §70 in SGB V on quality, humanity and economic efficiency is operationalized.
In level 3 “Regionalization”, the evidence-based health care content from level 2 is adopted. The state ministries, together with local authorities, ensure the regional design and the adaptation of needs to the socio-demographic and geopolitical conditions. Here, level 2 treatment pathways are translated into regional supply chains.
The country-specific bodies of the previous self-administration work constructively and cooperatively. The patient's well-being always takes precedence over the interests of the organ members. The requirement for allocative efficiency always applies to the use of resources: the means always follow the goal and purpose as well as the type, scope and quality of the services.
In level 4 “Organizing care” the outpatient, inpatient and rehabilitation facilities work together on the basis of the treatment chains. To do this, they follow the principles of Donabedian and organize a) access to their facilities, b) the internal provision of services and c) the continuity of care in cooperation with other facilities. At this level, the requirements of the health system meet the business orientation of the facilities. These should achieve an appropriate operating result. In salu.TOP, patient well-being always takes precedence over profit optimization.
The facilities create the working conditions for the service providers and thus the conditions for optimal care in level 5 “Treat”. The patient decides on the treatment itself within the scope of his or her individual possibilities. Based on this informed decision, the treatment team applies its professional skills.
The limits for care are the evidence-based needs and the available resources as well as the framework conditions and ethical requirements of the higher levels. The tried and tested requirement “Benefit is greater than harm” ensures that patient well-being always comes first, and the quality of the indication plays a special role.
The rules in a reality check
According to the criteria of systems theory, our healthcare system is a complex system. Complex means that the actual effect of interventions through laws, guidelines or regulations cannot fundamentally be predicted. This is due to the high level of internal networking and the countless and non-transparent rules of the game between those involved.
The following section shows how to reduce complexity through goals, responsibility and transparency. In this way, the health system corrects and optimizes itself in many areas in the sense of a learning system.

Current legislative initiatives
The functionality of the salu.TOP rules was tested using six legislative initiatives from this and the last legislative period. The following were selected: Appointment Service and Care Act (TSVG), Nursing Personnel Lower Limits Ordinance (PpUGV), quality indicators relevant to planning (Plan-QI-RL), Implant Register Establishment Act (EIRD), Minimum Quantity Regulation (Mm-R), electr. Medicines Information Ordinance (EAMIV). They show that the application of the rules would have made the initiatives unnecessary or at least significantly reduced in scope. [Piwernetz and Neugebauer, 2019].
The example of problems with appointments with specialists clearly shows the different ways of dealing with the problem. Under the current conditions of requirements legislation by the Bundestag in order to solve scheduling problems, with the methods and rules of salu.TOP, the facilities in level 2 “Organize care” regulate this themselves. The results are reported in the regional health reporting.
Similar differences can also be presented for the problems of “nursing staff minimum limits” and for “minimum quantities”. The problem with minimum quantities does not exist at all because salu.TOP is a needs-based system and the supply requirements for these treatments are carried out at specific, accredited centers.
The main differences are that in the current healthcare system there are no binding goals for those taking action, responsibility for the results is not assigned and there is no transparency about the use of resources and the results achieved. Results always mean the increase in health for patients and the quality of the organization of health care.

Future-oriented projects
Several requirements derived from the rules, framework conditions and ethical requirements have already been successfully implemented in some countries and projects.
In Germany, health goals were described as early as 2005, but were not consistently implemented in everyday care [Kurth, 2006; Hess, 2012; Buses, 2016]. There are currently no operationalized care goals.
In 2007, a Konrad Adenauer Foundation project developed the basis for setting ethical standards. The results are still current. In particular, conflicting goals between humanity and competition were explored [Spahn, 2007; Hedges, 2007; Schmidt-Jortzig, 2007]. As editor, Hacker summarizes suggestions on how medicine and economics could be further developed together [Hacker, 2016].
The concepts of Evidence-Based Medicine [Sackett, 1996], Evidence-Based Healthcare [Gray, 2004] and Value-Based Heathcare [Porter, 2012] have lost none of their relevance. They are among the basic methods implemented in salu.TOP.
In 2011, Austria published health goals and assigned responsibilities within the system [Federal Ministry of Health and Women, Austria (BMGF), 2011]. The achievement of goals is reported regularly [BMGF, 2017].
The health maintenance organization Innermountain HealthCare (IMHC) in the state of Utah in the USA has been showing for years how a powerful and efficient care system can be implemented for the mutual benefit of patients and HMOs with more than 900,000 insured people [Abelson, 2016; James, 2018]. The proven methods can be adapted.
Sweden has created the basis for needs-based care [Broqvist, 2011] and regularly evaluates the results [Sandman, 2018]. In Denmark, the government has launched a structured quality initiative with concrete quality goals [Nørby, 2018] and is continually improving it [Jylling, 2018].
Patient involvement in medical decisions has a long history in other countries. The demand “Nothing about me without me” dates back to 2001 [DelBanco et al., 2001]. In 2012, the “Open Notes” initiative took transparency and patient orientation to a new level. It opens the records of their treating doctor to patients in electronic form [DelBanco et al., 2012].
outlook
Rules, framework conditions and ethical requirements of salu.TOP offer the basic design principles for a healthcare system that...
• is goal-oriented towards patient well-being,
• is based on available evidence,
• is oriented towards supply needs,
• uses the available resources in a targeted and efficient manner,
• respects and uses the competence and commitment of service providers,
• organizes itself, continuously learns and incorporates future-oriented developments,
• and is transparent in results, performance and resource consumption.

In this sense, salu.TOP provides a blueprint for a healthcare system that we actually deserve. This results in three options for action:
1. The salu.TOP reference makes it clear where our healthcare system can be optimized. The elements of current care that need to be reformed are becoming apparent.
2. Deficit analyzes have been reported on the five levels for a long time. With salu.TOP you can structure them and evaluate them according to consequences and possible corrections.
3. On this basis, those responsible at the respective levels can decide on priorities and time frames for concrete improvements and regularly and transparently present progress to the public.

Numerous existing and proven elements and regulations can be integrated into salu.TOP and lighthouse projects from abroad can be specifically adapted.
In economics, Nobel Prizes were recently awarded for exposing “homo oeconomicus” as a chimera. There is also no such thing as a “homo sanitarius” – i.e. the being who only behaves rationally in the health system in the interests of the common good. Anyone who wants to see it can see that our health system can neither be rationally controlled nor sustainably changed through interventions in the form of laws, guidelines or regulations alone.
What we need today are binding goals, clear responsibilities and timely transparency. Medical progress and digital transformation will not wait. It is high time for action. <<
from:
Dr. Dr. Klaus Piwernetz, Managing Director of medimaxx health management GmbH
and Univ.-Prof. Dr. Prof. hc Dr. hc Edmund AM Neugebauer, President of the Brandenburg Theodor Fontane Medical School (MHB).

Citation note: