The work of Dr. Axel Munte, outgoing CEO of KV Bayern, said that his efforts were solely aimed at securing more of the nationwide fee cake for Bavarian doctors. It is undisputed that he succeeded in this during his term of office, which has now ended. Nevertheless, for him personally, the focus is not so much on the fees, but rather on the rock-solid conviction that good medical quality has its value and that the quality achieved through good fees then has its healthcare-relevant and ultimately also economic benefits. The most important means of doing this is health services research and numerous care contracts and projects are modeled on by other KVs. When it comes to outpatient medical care, Bavaria certainly seems to be a kind of “model country” in which the future of care is already partly being lived today.

>> Mr. Dr. Munte, in the election for the KVB representative assembly that has just ended, the list of the Bavarian General Practitioners Association with top candidate Dr. Wolfgang Hoppenthaller. What impact do you think this election result will have on the “Bavarian path” taken during your term of office and on the future of collective and selective contracting in Bavaria? And: Why weren't you re-elected?
Bavaria's doctors have been extremely unsettled by the reforms of the past two years - centralized fee reforms have led to severe upheavals and thus deprived doctors of their planning security. Although the KVB was only the “enforcer” of the federal regulations, many doctors have lost trust in the current system and joined the strongest fighter in the German medical profession in this election. To what extent the election result will have an impact on the “Bavarian way” of quality orientation remains to be seen. First of all, the now elected representative assembly will determine the new board in January.

What experiences led to your personal commitment to health services research?
When I started as a practicing doctor, my everyday life was characterized by a flood of paper. Diagnoses, treatment steps and so on, everything was recorded by hand on index cards, and after a while it was difficult to decipher many things yourself. It was difficult to exchange ideas between doctors. Although information was written down by a doctor, it was not in a form that, for example, made it easy to see the passage of time afterwards - a disadvantage that had to be remedied in the interest of the individual patient. In my opinion, the solution is electronic documentation of medical data - provided, of course, that data protection is guaranteed in every respect.

In the inpatient sector, healthcare research based on this is almost an integral part...
... but a much greater challenge in the outpatient area. After all, the data that is lying dormant in the individual practices must first be combined into a large “data pool”. In Bavaria we have developed a web-based documentation portal specifically for this purpose.

But data alone is not enough to gain knowledge.
Exactly. Data must be used and must be evaluated. For example, we have already found out that the incidence of colon cancer is distributed differently in Bavaria - and we can now advocate for appropriate recommendations for action - keyword invitations for early detection of colon cancer. The patients benefit from this - and that is my greatest motivation.

Do you evaluate this data yourself?
No. I even explicitly forbade my employees to do this. Nobody who collects their own data should evaluate it themselves; this applies to chambers, health insurance companies or associations of statutory health insurance physicians. We always advertise studies publicly and thus find the best healthcare research partners for each task - and not just in Bavaria, but now also nationwide.
Health care research and health care evaluation are an important concern of the KVB board, you write on your website. What does that mean in detail?

There are several reasons for a care evaluation. In Bavaria, in collaboration with specialists, we have introduced quality measures in various outpatient service areas - from prenatal diagnostics to early detection of colon cancer, which are generally intended to improve structural and process quality. This is exactly where care evaluation comes into play, because it is of course important that we evaluate our quality measures in order to check their effectiveness and, if necessary, readjust them.

And what does the patient get out of it?
Health services research is important in order to improve medical care and, for example, to detect illnesses at an early stage. To stay with the example of colon cancer: Thanks to more than a million documented data sets, we can increasingly track down the causes of colon cancer, make recommendations such as targeted invitations and thus reduce colon cancer mortality in the long term. Health services research also serves to ensure transparency about outpatient services. For example, in cooperation with the State Association for Outpatient Surgery, we conducted a study on patient satisfaction after outpatient surgery. While such evaluations are commonplace in the inpatient sector, we are still lagging behind in the outpatient sector.

What came out of it?
96 percent of the patients surveyed would have an outpatient operation again. The results are good and important evidence of the quality of outpatient services. Everyone benefits from the corresponding results: doctors, health insurance companies and ultimately, of course, the patients.

Transparency is also important, especially when it comes to performance - especially when it comes to the distribution of fees.
Exactly. Because according to the current plans for the GKV Financing Act, Bavaria is supposed to be disadvantaged; we are essentially being punished for our good care structures. In Bavaria, many operations are carried out on an outpatient basis; other federal states would not be able to do this due to a lack of outpatient care structures. Operations carried out on an outpatient basis also trigger follow-up costs in the outpatient sector that arise in the inpatient sector in other federal states. We, on the other hand, should now be “punished” for this; a disadvantage not only for doctors, but of course also for the payers. This shows that we still think too much in terms of different “financial pots” - outpatient/inpatient - and that health services research is important for transparency regarding service provision.

Can doctors from outpatient care carry out healthcare research themselves? Conversely, how much do doctors need results from health services research?
Of course, practicing physicians can also conduct healthcare research by collecting their individual data treasures in a centrally structured manner and scientifically evaluating them. We have in
Bavaria has created a web-based documentation portal for this purpose: “OPAL”, the “online portal for outpatient services”. There, practicing doctors can document medical data in various service areas online. We evaluate the documentation accordingly - taking data protection regulations into account. In a nutshell: Health services research in the outpatient sector is teamwork - every resident doctor makes a contribution.

And how do the participating doctors receive feedback? This is the only way every doctor can assess his or her therapeutic behavior?
Of course, practicing physicians should not “document across the board” without learning about the evaluations. This is also very important for motivation! Our doctors therefore receive two types of information: Firstly, their personal results, often in comparison to other doctors in their specialist group, in order to allow individual benchmarking. For example, it's about detection rates of anomalies or complication rates during examinations.

And secondly?
We also inform our doctors about the evaluation results at an aggregate level, for example about the spatial distribution of colon cancer incidence in Bavaria. This is also important so that the participants see that they are not “documenting in general”, but that their documentation represents an important basis for health services research.

The Bavarian Association of Statutory Health Insurance Physicians is involved in many research projects and evaluations. What are the basic directions of the KVB's involvement in health services research?
First of all, as part of health services research, the KVB is committed to creating transparency in the quality of outpatient care - towards patients and payers, but also opinion leaders in politics. In this way, possible deficits can be identified and remedied - or the high quality of outpatient care can be presented and communicated.
Secondly, we would of course like to scientifically evaluate the various quality measures that we have brought together under the umbrella of our quality program “Excellent Patient Care” (www.auszeichene-patientenbedarf.de). We currently have 17 quality measures in a wide variety of performance areas, in which over 20 specialist groups can currently take part. The evaluation has already taken place for the quality measures “Outpatient Operations”, “Colonoscopy” and “Electronic Documentation in Pregnancy”, while for the quality measure “Tonsillotomy” we and the evaluators are busy planning and collecting data. And thirdly, we use the data collected as part of our quality measures for medical care research.

Can you give an example?
For example, the Institute for Cancer Epidemiology at the University of Lübeck, together with the Bavarian Cancer Registry and us, created a regional comparison of the incidence of colorectal cancer between 2006 and 2008 in Bavaria. The findings of this study are an important first step towards better recognizing regional differences in the frequency of colorectal cancer - including the precursors -, identifying risk factors accordingly and deriving appropriate recommendations for action.

What were the important initial findings?
For example, it has been shown that the burden of colorectal cancer is high in regions where colonoscopy participation is lower and social indicators are weaker. Through this study and additional analyses, we are now in a position to specifically strengthen primary and secondary prevention at the regional level. The implementation of an organized request or invitation process for colorectal cancer screening appears to be an effective means of secondary prevention in order to substantially increase participation in screening.

What happens to these findings?
The KVB is currently in discussions at federal and state levels to implement a pilot project. The regions identified by the study, with low participation and a high burden of colon cancer, are ideal for a model project to reach people who cannot be reached through current opportunistic screening.

Where are the opportunities and problems in cooperation with the pharmaceutical industry?
One thing is clear: pharmaceutical companies are commercial enterprises whose goal is to generate the highest possible profits. KVs do not have this ambition. For us, the best possible outpatient care is our priority. Ensuring this - and, if necessary, optimizing it - is a central task of a modern CT. In the next step, this also includes solid pharmacotherapy advice for our members. One of our biggest challenges is to evaluate the study results from the pharmaceutical industry. Of course we have an advantage: As a corporation under public law, we are completely independent and not subject to any sales constraints. But this is also where the opportunities for cooperation with the pharmaceutical industry lie. In research collaborations with KVen, holistic transparency is guaranteed - with regard to study background, design and, in particular, results - this also applies to results that may be unpleasant for the pharmaceutical industry.

Nevertheless, the points of contact with the pharmaceutical industry must certainly be more structured and, in particular, the framework conditions for cooperation must be defined.
This is essential. One of the planned areas of cooperation is the implementation of joint healthcare research projects. The problem is obvious: although many drugs are tested in years of studies before they are approved, their effect is then hardly evaluated in the real world of care. However, studies are also useful here in order to minimize risks for patients and, if necessary, to optimize the relationship between costs and benefits. This is where the opportunities lie for cooperation between the pharmaceutical industry and KVen, especially with regard to the requirements of the upcoming AMNOG.

When do you find collaborations with industry problematic?
From my point of view, when they are not transparent. That's why we professionalized the contacts and created a transparent basis for objective healthcare research projects by the KVB and the pharmaceutical industry with “Pharaoh”.

What are the central points of these conditions for cooperation with the pharmaceutical industry? And how do they prove themselves in the practical implementation of joint projects?
At the beginning of a possible cooperation, we always define clearly defined questions and goals. In addition, absolute transparency is contractually agreed - with regard to objectives, implementation and, in particular, the complete and objective presentation of the results. For this purpose, documents such as study protocols and results reports are made available on the cooperation partner's homepage. We have published all collaborations - regardless of who we are conducting a study with - on our homepage at www.kvb.de in the Partner/Health Care Research section.
The actual implementation of supply projects then takes place according to a clearly defined process. For example, we use sample documents for the individual phases of a project and define clear responsibilities. We have also defined the legal, financial and data protection framework.

What legal framework is there for this?
As a corporation under public law, we are of course subject to legal restrictions regarding our area of activity. Activities that do not belong to our “sovereign mandate” according to SGB V must be approved by our legal supervisory authority, i.e. the Bavarian State Ministry for the Environment and Health, in accordance with Section 75 Paragraph 6 SGB V. Approval of the research project is a mandatory requirement for implementation.

And what are the financial conditions?
As a corporation under public law, we finance ourselves from the contributions of our members. We are obliged to use these for specific purposes for sovereign or approved tasks. Health care research projects, unless they are part of the sovereign mandate, must be financed using other means to cover costs.

So pharmaceutical companies are particularly in demand here?
True, but research-based pharmaceutical companies can only invest funds in accordance with the ethics manual and based on indications. That's why we create a financial plan before every project and agree on it with our potential partner. Ideally, we also raise third-party funds, for example as part of federal funding projects. For example, our “DiMelli” study on children and adolescents with newly discovered diabetes, which we are conducting in cooperation with the Technical University of Munich, is funded by the Federal Ministry of Education and Research - however, no pharmaceutical company is involved in this study.

Do you see common approaches to health care research studies with health insurance companies? Where are the difficulties and where are the opportunities?
The interest of the health insurance companies in our planned or already carried out scientific evaluations is great and also shows that we definitely have common approaches to health care research with the health insurance companies. This is all the more gratifying because, especially given the current financial situation of the German healthcare system, untapped potential should be exploited. The greatest opportunities lie, among other things, in the use of cross-sector data sets. For example, in the study on the quality measure “Outpatient Operations” carried out together with the Ludwig Maximilian University of Munich and the Federal Association for Outpatient Surgery, we examined patient outcomes after an outpatient operation. For this purpose, we were able to use outpatient and - thanks to the commitment of the health insurance companies - also inpatient billing data. The great opportunity of research collaborations with health insurance companies is simply that we can look beyond outpatient care and, in the future, conduct research across sectors.

What challenges need to be overcome?
In order to get as comprehensive a picture of the population as possible, we would theoretically ideally have to work with all health insurance companies on a topic. Otherwise, purely theoretically, we can only make statements about the insured persons of a single health insurance company. Since the insured structure of the individual health insurance companies differs significantly, it is often difficult to draw conclusions about the entire population. The solution would be to work with all health insurance companies, which is logistically not possible with 160 health insurance companies in the statutory health insurance sector alone. In addition, both partners (both health insurance companies and KVB) have reservations when it comes to exchanging data. By that I don't even mean because of data protection, as this is guaranteed in any case. It's more about the fact that both partners could fear that the other could use the data, for example for fee negotiations. Here you would have to contractually agree on the confidential handling of the data - also within the respective organization.

In addition to medical services, communication is a crucially important factor in healthcare. How do you promote communication between doctors and patients?
You are absolutely right! Communication is extremely important for healthcare - and understandable communication. Patients need to understand their diagnosis, its triggers and the reasons for their doctors' recommendations for action. For example, in the area of prevention, a good educational discussion can, in the best case scenario, motivate patients to undergo a preventive examination. As part of our quality measure “Colon Cancer Prevention”, for example, we motivate our doctors to electronically document the consultation for early detection of colon cancer. The documentation serves as a guide for the doctor during the conversation. This ensures that patients receive all the information relevant to them - in an understandable form. The result is a quality-assured consultation - for which participating doctors receive an additional fee.
We also support participating doctors in the area of prenatal diagnostics by incorporating a function into the electronic documentation that allows the doctor to create a patient letter at the push of a button. This letter explains the results and importance of the ultrasound scan to the pregnant woman in an understandable way. Participating doctors also receive a fee supplement for this. The two examples show how communication can be promoted and doctors can also be financially rewarded for their commitment.

What role does communication play in health services research?
A very important one! Of course, evaluation results must always be communicated transparently. Decision makers in particular should be informed about study results.

Supply management is becoming more and more important. Where do you see the big lines for the future here? How intensively does care management have to be linked to health care research?
In my opinion, the supply management of the future is the “Pay for Performance” approach - P4P for short, i.e. quality-oriented remuneration. P4P is becoming increasingly important internationally and is a pioneering instrument for increasing quality and reducing costs in healthcare. Many of our quality measures use the surcharge or surcharge and deduction approach. This approach creates financial incentives for transparent - i.e. proven - high-quality care. This motivates doctors to participate.

So, in principle, no meaningful healthcare management can be created without healthcare research?
This is true. Health care research based on objective criteria is necessary for almost all steps of care management, from identifying care deficits to designing care models and measuring the success of established care models. I advocate for more intensive use of health care research, both to create transparency and to support health care management - but of course only in areas where this makes sense.

The Bavarian Health Prize, which has just been awarded for the first time, is intended to honor and support projects that - according to the joint call for proposals from the KV Bayerns and the Vereinigte IKK - "contribute in a particularly creative and innovative way to high-quality, outpatient medical care in Bavaria" and thereby " should provide sustainable benefits, be implemented according to the criteria of economic efficiency and should serve as a role model for other regions. Dr. Munte, how many projects applied for this prize and what insights do you gain from this as an organizer and juror?
We received a total of 54 applications. We were very pleased with this great response in the first year. I was particularly impressed by the high level of personal and often voluntary commitment with which the projects were and are being implemented. And that applies to all projects, not just the award winners. Especially in rural regions, doctors have developed many good approaches to offer patients optimal care despite the often long distances. I would be happy if some of the projects nominated for the Bavarian Health Prize were taken as role models and spread further.

Bavaria seems to be a kind of “model country” in outpatient medical care since you started the “Excellent Patient Care” quality program in 2008. Now one could say - to put it negatively - that the Bavarian doctors needed this more urgently than their colleagues in other federal states, or from a positive perspective that such a quality program was only possible in Bavaria due to the already good outpatient care. How did you argue in 2008?
The fact is that Germany offers its insured persons a very high level of care compared to international standards. Nevertheless, there are always supply areas in which there are deficits that cannot be eliminated quickly at the federal level, but can be eliminated within the framework of a regional quality measure. When introducing our quality program, I was not only concerned with optimizing individual areas of care, but also, in particular, with transparently presenting the existing quality within outpatient care. My vision was and is that doctors who agree to provide above-average standards in process and structural quality will be appropriately “rewarded” for doing so. This includes financial incentives - the keyword "Pay for Performance" - as well as possible marketing effects, such as the awarding of our "seal of quality" in the relevant care area, the certificate for the doctor's practice and the entry in our special doctor search on www. excellent-patientcare.de.

The approach back then was really new, but is Bavaria's KV still a pioneer for the federal territory today?
New ideas always need a pioneer - a role that is not always entirely pleasant and for which one often comes under criticism. I was still happy to take on this role and withstood the criticism in order to further realize my vision. I feel encouraged on my path, as more and more state KVs and even the KBV have recently approached us to take over our supply contracts. For example, seven other KVs have now taken over the contract for our quality measure “tonsillotomy” - i.e. the reduction of the palatine tonsils in children.

As part of the GKV-WSG, the possibilities of KVs for regional contracts were to be severely restricted, which they managed to prevent by introducing the so-called “quality paragraph” 136 paragraph 4. To this end, you spent a year in discussions with political decision-makers in which you promoted the Bavarian approach to quality-oriented remuneration. What pro or con opinions did you hear?
That was a tough fight back then. I am all the more pleased today that the “Quality Paragraph” has finally been included in the law. At that time we felt a lot of tailwind but also a lot of headwind. The main argument was of course our existing experiences. After all, we had already worked with surcharges and deductions (higher and lower point values at the time) and were already able to demonstrate the control effect. Our examples were tangible; we were able to show political decision-makers live how, for example, our specialist knowledge tests take place online or how our doctors documented medical data online back then. Given the limited resources in the healthcare system, the approach of quality-oriented remuneration is of course also an excellent option for a fair distribution of fees.

Doubters will certainly ask the important question of whether your Bavarian approach could even be implemented “on a large scale”, i.e. nationwide?
Absolutely. And it was particularly questioned whether financially neutral solutions - and that is the principle of the “quality paragraph” - would actually be technically and organizationally feasible. The health insurance companies in particular feared that the health insurance companies could use the “quality paragraph” as a “trick” to negotiate additional reimbursement. In times of constant reform, it was also doubted whether the new paragraph would even work in conjunction with the other legal regulations. But a look back shows me today: It was and is possible to implement it. And of course we don't “trick” any cash registers - even if I definitely believe that in some areas a surcharge system should give way to the bonus-malus system. It is only when it comes to compatibility with other legal regulations that we actually have more and more problems - further evidence that the system is too complex and that good regulations are gradually being replaced by increasingly complicated regulations.

Role models always need imitators. What is hindering the translation of the Bavarian model projects to other federal states or regions?
First of all, of course, there is the skepticism and often clear resistance from the medical profession. The introduction back then was also a hard struggle - often against the wishes of our own members. A rethink has now taken place. We increasingly have successful examples of how projects have secured higher remuneration for specialist groups. The number of participants in our projects is now increasing continuously - and not only that. The doctors themselves are also thinking about how care could be improved. This is impressively demonstrated by our “ideas competition” that we announced in the winter of 2009/2010. At that time, our members were able to apply with new ideas for quality measures. More than 30 contract ideas were submitted back then, some of which we have already implemented. Our latest measure, “Risk prevention when you want to have children,” is based on a concept suggested by a practicing gynecologist. The example shows me that, at least in Bavaria, a rethink is slowly taking place. However, my suspicion is that the resistance is still present to a greater extent in other federal states.

The second challenge is certainly the necessary IT infrastructure.
Exactly, because electronic documentation and online tutorials require appropriate web-based platforms. Many KVs don't have something like this and unfortunately there is still a certain competitive spirit in the KV system. There is a certain inhibition threshold to adopt products from “sister KVen”.

What would be your suggestion?
We should pull together, share our experiences and have no inhibitions about adopting or offering good products. Against this background, I am very pleased that the National Association of Statutory Health Insurance Physicians (KBV) has decided to offer our online portal for outpatient services - OPAL for short - nationwide. We now have a small branch of the KBV here in Munich, where the portal is developed and operated centrally for all KVs. In this way, we use our accumulated experience to promote the quality of outpatient care nationwide.

Accordingly, the IT age has already begun in Bavaria, in contrast to other federal states.
And that was seven years ago. Since then, we have acted as a model for a nationwide IT structure. After all, in 2003 we created KV-SafeNet, a virtual private network that has now established itself as the nationwide networking standard in the outpatient medical community. Especially in the IT sector - regardless of whether this means the introduction of electronic documentation, online specialist knowledge tests or networking opportunities between practices and KVs - we see ourselves repeatedly confirmed that the KVB is a pioneer in Germany. It's been that way for a long time and should stay that way!

Such projects certainly require employees with the appropriate professional skills.
Here too, a rethink has begun, at least here at KVB. While we used to rightly concentrate more on the operational areas and recruit the appropriate personnel, since 2002 we have been continuously building up strategic business areas that deal with the development of services, IT solutions and quality measures. In order for KVs to develop from comfortable authorities to modern service companies, we need appropriate products or software solutions. We have 60 employees in Bavaria dealing with such strategic issues.

Quality-oriented remuneration must have one thing in mind if it is not only to result in an increase in fees for the doctor: the patient. With what instruments, ideas and arguments that go beyond the existing warranty mandate and Hippocratic oath of the medical profession were you able to achieve a clear benefit for the patient?
Anyone who knows me knows that providing the best possible patient care is my top priority. With this vision in mind, I was and continue to be prepared to accept criticism from the medical profession. The advantages for patients that result from the individual quality measures are diverse: In addition to the general quality assurance of the diagnosis and examination, there are very specific aspects from which patients benefit. For example, the “Excellent Patient Care” doctor search offers a kind of compass: Using objective quality criteria, patients can find doctors from over 20 different specialties in their area using the online search.

Which of the projects introduced since 2003 - starting with mammography screening - is the one that you consider to be a role model nationwide or perhaps across Europe?
You have already mentioned it: Mammography screening, i.e. the introduction of a systematic early detection examination for breast cancer, was our first project that was born here and was then adapted to the requirements of the cancer early detection guidelines in 2007 and integrated into the nationwide screening. This was also a particularly complex project, not least because of the standardized chain of findings. The X-ray images of at least two different findings are then examined - and this again requires a secure online connection. In this context, we have developed the online connection variant KV-SafeNet.
But we have also set standards in the area of hygiene: As part of the so-called “HYGEA study” in endoscope tests in Munich in 1999/2000, almost half of the endoscopes examined showed hygienic defects - and that was with voluntary participation. As a consequence, we have established regular microbiological examinations of flexible endoscopes in the practices of general practitioners. The Robert Koch Institute (RKI) then developed the KVB in collaboration with Dr. Lutz Bader from the Max von Pettenkofer Institute at the Ludwig Maximilians University in Munich adopted the hygiene guidelines. This is how the project from back then became a nationwide standard. By the way: If the results of the endoscope sampling are without any complaints, the microbiological examination is free of charge for participating doctors: the costs are reimbursed by the statutory health insurance companies.

In selective contracts, such as those concluded between AOK and some BKKs and MEDI, there is a bonus but no penalty. However, KVB's quality-oriented remuneration often has a combined bonus-malus system. Would you consider that a success factor?
I have been advocating for medical compensation to be controlled through quality for years. However, a pure bonus system requires additional funds from the health insurance companies. And since the introduction of the health fund, through which financial resources are withdrawn from Bavaria, the health insurance companies have been very restrictive with regard to additional funds. The “Bonus-Malus System”, which was incorporated into law with Section 136 Paragraph (4) at the initiative of the KVB, gives us the opportunity to reward quality and still remain financially neutral for the system. Our evaluations confirm: The control effect towards proven quality works. But of course such a system also has its limits. For example, if almost all doctors meet the quality requirements, supplements for participants can no longer be financed from the remuneration reductions of non-participants. In fund negotiations, I primarily advocate pure bonus systems. And on October 1st we were able to conclude several new contracts for various specialist groups, including with AOK Bayern.

Another success factor is sectoral linkages. What about the corresponding interface definitions in Bavaria? How are hospital, doctor and specialist lines linked on a contractual basis?
This raises a sore point, because unfortunately there is no real sectoral link yet - nowhere in Germany, by the way. Such a link would be possible with the successful KV-SafeNet model, but to date the necessary standards between doctor information systems and hospital information systems are missing. These standards are a mandatory requirement for the easy exchange of diagnostic data, for example. You could say we need an interpreter between systems, and indeed between all systems. Only when this interpreter exists and is integrated can a true sectoral link be created. Conclusion: It's the system manufacturers' turn. <<

The conversation was conducted by MVF editor Prof. Dr. Reinhold Roski and MVF editor-in-chief Peter Stegmaier.