The qualified economist Thomas Ballast is a “health insurance man”: in 1992 he was a consultant for “medical care” at the Federal Association of Guild Health Insurance Funds, in 1995 he was head of the “Doctors” department at the VdAK, and in 2008 he was chairman of the board of the Association of Replacement Insurance Funds. V. (vdek) and since 2012 deputy chairman of the board of the Techniker Krankenkasse. Here he is responsible for the outpatient and inpatient care, information technology and internal services divisions as well as for the health sciences department, the strategic care management department and for the procurement and data protection departments.

>> Mr. Ballast, you have been deputy chairman of the Techniker Krankenkasse for two years and are particularly responsible for the health sciences area. What have you been able to accomplish in these 24 months?
In the area of WINEG, the TK was already very well positioned, for example when it comes to dealing with our routine data, collaborating with chairs or with scientific cooperation partners. At the beginning of my term in office, we sat down with WINEG in several workshops. The aim was to analyze how the acceptance and visibility of WINEG can be further increased externally in the scientific community, but especially also internally.

Have you made any progress with this?
We have identified four topic areas in which WINEG will position itself more strongly. The first is the scientific processing of routine data, a field in which we also process many inquiries from potential cooperation partners. The second is the topic of patient safety, an area in which we have been active for a long time as a member of the “Patient Safety Action Alliance”. A third topic area is internal - this is about how the scientific language can be translated into understandable language so that as many of our employees as possible can be adequately informed. The fourth topic area, which is very important to me personally, is the freestyle, so to speak, in which we concentrate on topic areas in which we suspect excess or incorrect care.

Why not undersupply too?
There are sufficient social forces and interests that draw attention to the places where there is not enough care, which is absolutely fine. But we want to position WINEG as a scientific institute for our health insurance company, precisely at the point where over- or incorrect care often comes to the detriment of the patient.

Which essentially means you're killing two birds with one stone.
True. By contributing to quality and patient safety, resources that are being used in the wrong place are automatically identified. But what matters most to me is the perspective: economics is important, but not the decisive fact.

Which areas do you particularly want to focus on?
The range of topics ranges from the question of the correct use of medication, to questions about the development of indications, for example in the area of mental illnesses, to the frequency of operations or the correct use of medical devices. For example, the durability of certain prostheses has already been examined and it was found that there are significant problems.

What do you do with the resulting findings?
We publish our findings primarily in the scientific community. However, information is also produced that is relevant to a broader public.

You do scientific health services research and those that interest you individually as a health insurance fund. At the end of the day, what is a trade secret and what is there for science in general?
Scientists, including ours, generally don't like to work for the drawer, but rather want to publish. In this respect, I would say that all studies that were developed under scientific criteria should and can be published.

So everything that WINEG does?
Basically, this applies to everything that WINEG does. Even if your own projects are evaluated, the results should be documented and published at the end. Everything we do is in the interests of our insured people. As a result, the question of whether our studies are more science-oriented or more TC-oriented is relatively easy to answer: Neither, they should always serve to ensure the best possible care.

Where is the limit? What separates tough business and competition from improving care in a social sense?
That's actually hard to say. Of course, we also attach importance to not wasting money on projects that we do in social or political interests. This also applies to projects or products that we think will help us as a cash register to paint a positive image of ourselves in the market. The fact is that we - like all other health insurance companies - are not set up for profit. In this respect, our primary business goal is to ensure that we are positioned in a stable and future-proof manner. This means that, based on this focus, we invest a lot in the care of our insured people, because that is our core business.

Hand on heart: What is particularly important to you in health services research?
In general, the difficulty lies in finding out what health services research can and cannot do. Now the TK has a real wealth of routine data that we can draw on and with which we can do a lot. But unfortunately only at first glance. Because the problems begin with the second one. Because then questions arise that are anything but trivial: What exactly do I do with the statements that emerge from this data? Once you have answered this, the next one follows: How do I isolate developments or tendencies that I read from this data with regard to specific causalities?

What happens in actual day-to-day care is always the result of a multifactorial and multiprofessional process.
But that also makes the whole thing quite complicated. The analysis of routine data, for example, can very well determine that certain things have changed; something has become more or less somewhere. But what exactly do you do with these results? Have any treatment results become good, better or even worse? Is the observed change due to medical intervention taking place or not? Or simply that certain tendencies have manifested themselves in the population or in the environment?

What I mean is: The meaningfulness of routine data is limited.
To put it this way: They are relatively easy to analyze, but anything but easy to evaluate. Therefore, every analysis of routine data is accompanied by the question of how much meaningfulness can actually be generated from this data, which is the basis for the most common type of health services research. For this reason, we try - wherever possible - to supplement our data analyzes with other findings, whether using surveys or data from cooperation partners or from other countries, in order to generate greater meaningfulness.

To make matters worse, health is largely determined by general living conditions, nutrition and genetics, while only 10 to 15 percent is determined by medicine. And of these 10 to 15 percent, studies show us a very idealized world of medicine. Health care research alone could provide more reality. Is that what’s fascinating about this science for you too?
In general, I am extremely interested in the fact that with health services research, and in principle only with health services research, it is possible to determine how the actual everyday care routine develops beyond the clinical study situation, which always represents an artificial and constructed world. The slightly defeatist basic approach of the limited influence of medicine should not stop us from paying more attention to everyday care and the quality of care in the future. Because sometimes it is actually possible to point out negative developments and then influence them positively.

Routine data is certainly a treasure that you will certainly want to uncover. But what can actually be done with routine data and what can't?
The fundamental problem is that routine data per se is not collected to serve scientific purposes. They are used either for billing, for generating fund allocations or for other legal obligations, for example the quality documentation at DMP. This purpose alone can give rise to certain problems with the use of this data in studies. One of them is the difficulty of being able to develop time series because constantly changing billing regulations and different incentives have to be taken into account, as well as changes in the fee and flat rate catalogs. All of this makes it quite difficult to create time series and then draw the right conclusions from them. That is why the act of analytical evaluation, which isolates external from internal influences, is a very complex process.

Can you do that?
I think we've gotten pretty good at that. However, it also helps if comparison groups or comparison parameters across several populations are examined in parallel and compared with each other. Ideally, one would then observe the situation in which the change in external influences has an identical effect on both populations, which means that this comparison can provide valid information as to which influences need to be eliminated or scaled up. In order to obtain the necessary matched pairs, we use sophisticated procedures and actively apply them, for example to evaluate our IV contracts or coaching projects. This allows us to see fairly precisely how an intervention or design affects a particular population compared to another. For such questions, routine data can be used very well, which paints a very good picture of certain care realities.
The image of reality drawn by routine data will always differ from reality. But what is the question?
This is indeed a problem in static analysis. Nobody really knows to what extent an image is right or wrong. That's why you should always concentrate on statements that are as simple as possible. For example, you can say how often something happens, how often certain diagnoses are made, and then link these facts to certain demographic characteristics of patients. If you then correlate these findings with other data, for example from other countries, you can certainly draw rough conclusions about the actually existing supply structure. But I wouldn't do much more than that. That would overwhelm the routine data.

Where do you see excessive demands?
For some treatment or care outcomes in a region or patient population, the significance of routine data is finite. Here you should correlate data from other European countries - if available and available - in order to be able to compare different conditions with each other. However, it would still be a stretch to conclude that one population or region is sicker or healthier than another.

Where do you see problems when evaluating forms of care and approaches to care management?
Unfortunately, we do not have the necessary manpower and computer capacity available to us indefinitely. For this reason, operational processes generally take priority over scientific questions. But first and foremost, you always have to know what data is available where, and how questions can be translated so that something sensible comes out of it. But actually everything runs relatively smoothly for us once the question of data availability is clarified.

Is data protection a big concern for you? Or do you think its impact is greater than it actually is?
Data protection is not a problem, but of course it must be taken into account. At TK and certainly other health insurance companies, we handle our data in a very legally compliant manner. This means nothing other than that the first step is always the anonymization of data. Every new project is also coordinated with data protection officers.

Data protection is therefore not an obstacle, but a condition that simply has to be observed.
Particularly in projects with external cooperation partners whose hunger for data is strong and whose understanding of data protection is perhaps not so strong, coordination can be somewhat more complex. The trick is to take data protection into account without completely detracting from scientific interest. But so far I have not come across a project that failed because of this.

The development of demographics is one of the major problems of all societies, including that of the TK insured collective?
I'm not even sure to what extent this oft-touted demographic will actually hit.

Because people age healthier.
Today's 80-year-olds have a completely different biography than the generations before, where there were world wars with hunger situations. The enormous developments in environmental protection and primary prevention are already having their effects. Therefore, I have a certain hope that those who are now middle-aged will have a somewhat more favorable disease development in old age than those who are sick today. In addition, TK has a relatively young insured population, but on average it is getting a little older, also because we are growing. But we are still a long way from a real supply problem that would arise from a reversing age pyramid. Nevertheless, we are currently in the process of developing a new field, which we have the working title “Supply Network 60+”. The reason is the aging insured population structure, but we believe that there are particularly many of them who want to live in their home environment for as long as possible, be mobile as long as possible and stay as healthy as possible. To support this, we want to build and test a structure with which we can create an environment in which the home environment, mobility and health can be maintained for as long as possible through more intensive care from service providers, but also through health insurance companies and the use of technical aids can be preserved as much as possible. We are currently in the conception phase and will probably publish the results at the end of the year.

And this despite the fact that, as you yourself say, your budget is far from a real supply problem. The AOK, for example, has been hit harder.
All health insurance funds that have an older insured population on average tend to be more affected than we are. But we also have special focus points in our insured structure. Supply problems arise in TK, for example, where operations are carried out particularly frequently or where mental illnesses are diagnosed. Here we are significantly more affected than other health insurance companies. However, this is the effect of a historically grown structural question that goes back to the 1980s, when the TK was the first health insurance fund to take over psychotherapy. The effects of that decision back then continue to this day.

AMNOG theme. How do you use AMNOG information to promote innovation?
We prepare the information from the Federal Joint Committee for both patients and doctors in different designs and levels and then make this information available to interested patients and doctors.

This means that this is information that is translated for a specific target group.
You have to prepare information for specific target groups if you want it to be understandable. The good response, especially from doctors, shows that we seem to be succeeding. The difficulty is that doctors are basically bombarded with information, although you have to recognize which ones are interest-driven and how. That's why doctors are really grateful when they receive a short, concise, neutral presentation of information. We usually offer our insured persons a combination offer by providing, upon request, an overview of the medications prescribed to the patient over a certain period of time. Anyone who requests this overview will receive further patient information because we can then assume that there is a basic interest.

How many of your patients/insured persons are interested in this?
If you were to express this as a percentage, it would be a relatively sobering value. But you shouldn't let that discourage you. It's about the actual day-to-day care and the question of how information can be made accessible in such a way that it helps ensure that, on the one hand, medicines that are not needed are not additionally prescribed, but on the other hand, those whose benefits have actually been proven find a quicker route to care . Our “Innovation Report” is intended to clearly express that we are concerned with the topic of innovation in pharmaceutical supply. When we launched the “Innovation Report”, we were somewhat overtaken by AMNOG. But when we launched the project, there was no mention of AMNOG. Nevertheless, we still have a unique selling point because we will continue to look at the existing market, which is no longer the mandatory task of the G-BA following the recent AMNOG reform. The reactions of the pharmaceutical industry show that we are obviously not entirely wrong with this approach.

The medicines recognized as innovations by AMNOG are implemented very differently on the market, which is also causally linked to the way in which different KVs deal with the topic of innovation, as Dr. André Kleinfeld from INSIGHT Health showed at the last MVF congress “Innovation 2014”. Where do you see your role in promoting innovation?
Of course, KVs try to inform their doctors according to their respective goals. What worries us is the fact that, despite a positive AMNOG procedure, newly approved, innovative medicines are not being used quickly or sufficiently enough in the right indication area.

Why is that?
There are currently a handful of active ingredients that have gone through the AMNOG process and therefore essentially have the AMNOG seal of quality, but which are not used for the appropriate indication because their indication has been expanded. This results in more costs without proven additional benefits.

Despite all medical freedom, there should be prescription assistance.
A lot could certainly be achieved with software support. To do this, however, you would have to get access to the practice software, although the pharmaceutical industry has generally been making sure that the right pop-up opens in the right place for a long time.

There should be more accurate information about the prescribing process, which would certainly produce a better outcome.
This is exactly where we as an individual fund reach our limits. Although we have around 12 percent market share, the proportion of patients in the practice is probably lower. But for only around one in ten patients, such an approach probably doesn't make much sense.

We previously spoke about the ideal world of study and the real world of care, which has very little to do with an early benefit assessment of AMNOG.
Basically, the AMNOG process has been quite successful and works much better than many people previously claimed. The pharmaceutical industry worldwide is used to benefit assessments.

There are many managers in the pharmaceutical industry who claim that the German market is becoming unattractive for innovative active ingredients
A global market company will not be influenced by whether there is a benefit assessment in Germany or not. However, I understand when the industry complains that virtually every country has a different benefit assessment procedure. For example, in England, not only a benefit but also a cost-benefit assessment is carried out, which heavily involves Qaly; We, on the other hand, do a pure early benefit assessment without Qaly, but focus on determining life extension and, increasingly, on patient-relevant endpoints. Every benefit assessment system is based on the specifics of the respective system, which is always a reflection of a society.

Shouldn’t there still be a late benefit assessment?
The main question will be what basis new data can be produced for a late benefit assessment. That will certainly be health services research. But at the moment I understand the discussion that is being held in the G-BA, but especially in the IQWiG, to mean that the seemingly safe platform of evidence-based medicine must then be abandoned, which means that safe judgments can no longer be made. The circle closes here again, because in healthcare research, which is largely based on routine data, it is not possible to say exactly whether a particular result in the reality of healthcare can actually be traced back to a particular active ingredient or not. This would require new primary data generated specifically for health services research studies.

Could there be a solution for this?
I have some sympathy for the pharmaceutical industry when it says that it cannot set up another randomized controlled trial that produces results in five or even ten years. Seen this way, there is still no solution.

And what if there was a suitable method for this?
That would be awesome. The safety, tolerability, effect and adherence of a drug can only be determined under real-world care conditions. As a fund, we have a particular interest in such studies, provided they are methodologically sound. The methodologists have to get to it now.

What benefits has AMNOG brought to everyday care so far? Or can this question only be answered in five to ten years?
Doctors are now in a position to prescribe more specifically. Simply because they are no longer solely dependent on the industry's advertising activities, but rather, through the GBA assessment, they receive objective evidence as to which medication is worth switching a patient to and which is not. In many cases, this already avoids cost burdens. I don't see that the pharmaceutical industry has been significantly negatively affected by this; in fact, I'm following the wave of mergers with interest - the industry's coffers seem to be well filled.

The mergers probably have little to do with the possible effects of AMNOG. Logically, shouldn’t the existing market need to be addressed?
If it had been possible, it would certainly have been the right thing to do to analyze the existing market in a legally secure manner and with justifiable material and time expenditure. But we are talking about a market that represents a transitional phenomenon. It will take a maximum of ten years until the last patents expire, then the issue will resolve itself. There would have been a risk of triggering enormous legal problems by intervening in an existing market. The mere question of the order in which which drug or which segment in the existing market should be examined has a direct impact on the legal certainty of the companies concerned. Since it was foreseeable that this would give rise to many disputes and lawsuits that would drag on for years, with results that might not be available until the patent had already expired, it was certainly the better way to forego the appeal. And instead to concentrate on the area of new drugs. However, we show that the existing market is still of interest by continuing to analyze it ourselves, regardless of what the G-BA does.

What can and what should other actors do to implement innovation more quickly?
The statutory health insurance associations would be natural comrades-in-arms

But they are not comrades-in-arms, but mostly fight quite independently of each other.
There are already associations of statutory health insurance physicians that deal more with the topic of drug therapy than others, but this is usually based more on personnel rather than structural interests.

For example, it is structurally rather rare for health insurance companies and doctors to pull together.
In principle, we are more allies than opponents, because the associations of statutory health insurance physicians also have a great interest in doctors practicing rational pharmacotherapy and not one that depends on the marketing budget of the respective pharmaceutical companies. In this respect, we are united by the idea of not allowing industry to have too much influence.

Wouldn't other health insurance companies also be required here?
The AOKen are already doing a lot, often at the state level. As a nationally active fund, we focus primarily on topics that we can serve uniformly across the country, but that does not mean that we would close ourselves off to regional activities.

A backlog of innovation has been observed for some time, particularly in the area of integrated contracts. What would have to be done to resolve it?
At the beginning, a strict distinction should be made between product and process innovations. We are still very friendly when it comes to product innovations, whether it is a new drug or an innovative treatment method or a medical device. Germany is a market where, in our view, the industry has relatively good market access conditions, although the industry may see this a little differently. But I don't think we have a backlog of innovation here. When it comes to the question of process innovation and care structures and processes, however, one simply has to realize that the necessary instruments, which were created since the mid-1990s, have become quite cumbersome today. By this I mean, for example, practice networks, paragraphs 73a, b and c, model trials, integrated care and so on. You certainly no longer see the dynamics here that you could see five years ago.

Maybe we're running out of ideas?
From the mid-1990s, when the idea of managed care came relatively recently from America to Germany, there was politically initiated start-up funding for integrated care, which brought about a wave of change. This has generated a lot of energy on the part of the health insurance fund and also the service providers to think about new things and take new paths. It should not be forgotten that this took place at a time that was characterized by rigid budgets, strict requirements planning and highly separated sectors. The third factor at that time was the box office competition that had arisen as a result of the new social competition order, along with the need to differentiate oneself from one another and to offer different products. Today, however, we no longer have any start-up funding and therefore no longer have any economic incentives, nor, by the way, for the service providers, especially the doctors, who have seen a gigantic increase in fees in these years.

And then comes the Federal Insurance Office, with its restrictive supervisory practices, strictly lege artis.
Complaining is not appropriate. The BVA is tasked with treating all health insurance companies equally. The ideal of equal treatment gives rise to relatively rigid test catalogs, which of course have difficulty taking the circumstances of the individual case into account. However, especially in the area of these supply innovations, very specific constellations in a place or region are often important, which on the other hand also makes the negotiation processes quite complex. So that sometimes you ask yourself how a result came about in the end, even though there are actually good intentions on both sides. Everything together is already leading to a certain disillusionment at the moment.

What can cause movement again?
I rely to some extent on the legislature. Politicians want to streamline the relevant paragraphs and simplify them in a new constellation. If this succeeds, the existing energy could be concreted into actions again. The newly launched innovation fund also promises up to 225 million euros to support projects like these.

What do you think should be done with the remaining 75 million, which may already have been mentally distributed, in the field of health services research?
We are not terribly happy that the distribution of the money is handled by the Federal Joint Committee, which I am not arguing against the people involved, but rather against the structure. The G-BA is a body in which interests must first be balanced, which experience shows takes a certain amount of time.

You will think about guidelines and requirements.
Everything will be put out to tender, which is a complex process in itself. This will require a certain amount of patience from anyone who speculates on these means. I'm cautiously anticipating the second quarter of 2015. If it turns into 2016, I wouldn't be surprised either.

Which approaches will be supported by the Innovation Fund?
A meta-topic will certainly be supply in rural areas; another the technology. A completely new world of data, applications, data transfer, data collection, use of technical devices and smartphones is emerging everywhere. Only the health sector seems almost like an island where almost nothing moves.

With the immense imagination of many apps, software and big data applications, the real health sector is only marginally involved.
Until now.

Is that a danger? Or healthy caution?
I wouldn't say danger, I just find it annoying. We could do much more than we do if we got beyond the level of structural and role conflict. It is now almost ridiculous that KVs, hospitals and health insurance companies are fighting among themselves for data sovereignty instead of working together to provide better care.

One could almost speak of mutual paralysis.
No wonder we have little standardization in this increasingly important area. If you just look at practice software, hospital software and nursing software, you can see an enormous lack of interoperability. On the other hand, more and more apps are emerging in the area of health that use existing standards and, based on this, make technology tangible for patients. This is a trend that we as health insurance companies have to deal with, but in which we always quickly reach the limits of data protection. With these apps we enter a gray area between their private lives, where people are all too happy to share their personal information on Facebook, but as soon as a cash register with any vital parameters is involved, it becomes extremely difficult to define an interface , which appears to be sufficient for data protection. I still believe that new business models will emerge in this area that we cannot even imagine today, but that will change the supply situation.

For example, when technology and supply are brought together in rural areas.
You simply have to be allowed to think openly about whether and how the Internet or other data transfer options could enable new treatment options. This partly comes up against data protection and, above all, the ban on remote treatment, but at some point society has to ask itself whether certain standards or the coverage of basic services are more important to it.

Mr. Ballast, thank you very much for the interview. <<

The interview was conducted by MVF editor Prof. Dr. Reinhold Roski,
Interview edited by MVF editor-in-chief Peter Stegmaier.

Citation information: doi: 10.24945/MVF.03.14.1866-0533.1938

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