Output and implementation

Decision output

The decisions of the G-BA are published in the ‘Bundesgesetzblatt’. There is further no structured or formalized procedure in place to communicate the decision to the different parties involved in the implementation of a new service. The information is rather spread in an informal process taking place via the different working groups involved on the different levels of the decision-making process of the self-governance system.

39 In sect. 21 of the code of procedure the hierarchy of the evidence-based evaluation criteria are listed (GemeinsamerBundesausschuss, 2005).

The decision of the G-BA is legally binding and mandatory. The decisions of the G-BA are classified in judicial terms as an ‘untergesetzliche Norm’, which implies that it is below the category of law and regulation decreed by the Ministry of Health, but it has the character of a mandatory and legally binding norm and rule. These rules apply and are legally binding for the field of the SHI (not for the private insurances). Once a technology is excluded by the decision of the G-BA, the statutory sickness funds are not allowed to cover it. Private insurances are exempted of this rule and are allowed to cover such technologies. Only the legal way to appeal against G-BA decisions is through legal complaints. In general, however, such legal complaints are not successful. If there is a legal proceeding and the G-BA and the complainant is heard, then it was till now always the case that the position of the G-BA has been acknowledged and confirmed by such a legal proceeding. There were a few exceptions, but these cases were related to issues concerning competition and antitrust laws. In these cases questions are raised if the practice of the G-BA is actually compatible with existing European legislation. The G-BA can actually not be held accountable for possible incompatibilities with the European legislations. It is more the task of the government to make sure that the respective regulations and laws are compatible and not contradictory.⁴⁰ Implementation of a decision

When the G-BA decides on the inclusion of a service into the benefit package, its inclusion must be regulated. This involves definition of the actual benefit, and regulation of technical quality as well as qualification of the providers. The responsibility for definition of the benefit and quality assurance rests with separate committees who are not part of the G-BA: the committee on quality assurance and the committee on the specification of the reimbursement. The Valuation Committee works on the reimbursement details in close cooperation with the G-BA (e.g. in terms of description of the new service) and the committee working on the specifications of quality assurance. The discussions of these two aspects of the implementation are taking place in working groups that are appointed by the deciding boards. These working groups work and bargain on the details and present a proposal for the final decision. Generally, the groups work contemporarily in order to ensure a quick inclusion of the new service. Formally these entities are separate and ‘sovereign’, but practically a lot of communication and cooperation is taking place between these entities. The working groups involved in the process are

‘automatically’ (that is, by the nature of the self-governing system) aware and informed about the current issues. The moment it becomes clear that soon a certain issue will be on the agenda of the G-BA, the representatives of the joint self-governing system in the working groups can already inform their respective bodies.

Notably, implementation of a technology will not take place as long as no agreement is reached on the specification of quality assurance and the reimbursement details. This can sometimes be problematic.

There is an interplay; that is the more complicated a new service, the more extensive and elaborative the quality assurance agreements and the higher the possible reimbursement for the physicians. It is of course

40 It happened so far only once that a regulation released by the G-BA was interfering with existing European laws, but it was not related to the question of effectiveness, but to the question of free trade.

in the interest of the medical fraternity to reach an agreement for a reimbursement as high as possible for a specific service. The interest of the health insurance funds lies, however, in controlling the expenses for services. These opposing and conflicting interests of the physicians and the health insurance funds entails of course quite some bargaining. As a result, the competition is often hard in the Valuation Committee.

An agreement on quality aspects is made by a committee that is composed of representatives of the health insurance funds and of the National Association of Statutory Health Insurance Physicians. The quality assurance regulations describe which demands and standards the physicians have to meet that are offering this new service and technology. The agreement on quality assurance is normally a very detailed regulation and it can take quite some time to negotiate the details depending also very much on the degree of the controversy that the new service entails. This is for example illustrated by the acupuncture example.

Acupuncture is included in the benefit package for two indications only. Physicians who want to offer this service must have a qualification for pain therapy and psychosomatic medicine. Furthermore, the quality assurance regulations discuss which needles are allowed, what kind of room facilities are appropriate, how long a acupunctural treatment should go, how many hours of training in acupunctural treatment the physicians need to exhibit, etc.

A clear description of a service in the Uniform Value Scale (EBM) is stipulated as a condition for the provision of the respective service. The Valuation Committee defines the actual benefit for the insured, in terms of the EBM and the associated reimbursement rate. The EBM is part of the contract that is concluded between physicians and insurers at the federal level (the so-called ‘Bundesmantelverträge-Ärzte’, or BMV-Ä), which also regulates participation in ambulatory care, the pertinent aspects of quality assurance, and entitlement to benefits. Accordingly, definition of the EBM depends on consensus between the two contract parties, the Federal Association of SHI Physicians and representatives of the federal associations of sickness funds. Also the Valuation committee is set up with people from the joint self-governing bodies. If the Valuation Committee fails to reach consensus, at least two of its members or the Federal Ministry for Health and Social Security may demand that the extended Valuation Committee be brought in to resolve a split decision (SGB V, Sect. 87 para. 4). Resolutions are to be submitted to the Ministry of Health, which in the event of unresolved objection, may define alternative executions (Busse

& Riesberg, 2005).

The respective federal associations of the joint self-governing system (KBV etc.) provide channels and fora for further informal mechanisms of communication of the decision-making process. Till now there has been apparently no need to formalize such communication mechanisms; the informal mechanisms or better the joint self-governing system entails and includes the spreading and communicating aspect of the implementation of a new service.

Reappraisal

There is no systematic reappraisal mechanism in place. A decision can of course be revised or updated, but it has to be formally applied for. Any of the organizations represented in the G-BA (sickness funds, doctors, federation of hospitals, patients) can apply for such a reappraisal provided it is applied for with a

substantiated argumentation. Conflicting interests of insurers and physician sometimes drive the reappraisal process. In 2000, for example, there has been a discussion of bone densitometry for asymptomatic persons as a consequence of increased use as it was very attractive and well reimbursed as a service. It has been performed in large quantities and has been handled as a sort of ‘grey or opportunistic screening’; that is, a screening that does not need to be done in practice, but that is still performed as it is financially rewarding for the performing doctors. As a consequence, the G-BA excluded bone densitometry for asymptomatic patients (i.e., patients who do not show indications of having osteoporosis) from the SHI package. The reappraisal of including bone densitometry in the benefits catalogue has been discussed extensively and in a very controversial way. The application for reappraisal has been based on an extensive and evidence-based counselling process. Currently, the discussion about reimbursement is opened again as the situation has changed by the introduction of a new drug that allows treatment of osteoporotic patients in an early stage. This implies that the possibility of measuring the density of the bones gets a different meaning.

Interesting in this context are of course the informal mechanisms of prioritizing certain issues or not. Here there is quite some strategic and political margin. A few criteria have to be followed (see code of procedure of G-BA). There are several examples of claims for a reappraisal and re-consultation that have been made and that are waiting already for six or seven years to be dealt with. They have not been prioritized very highly and by this not dealt with, because no one of the responsible ones has a real interest to deal with them. One example is the first anamnesis in homoeopathic treatment (‘homoeopathische Erstanamnese’) which has till now only been delayed as it is not considered as important enough to be dealt with. There has been a request of reappraisal for this issue, but there is no real interest within the G-BA and till now it has been postponed by prioritizing other requests of reappraisal that are put forward.

The priorities are assigned by the G-BA itself, actually in the respective sub-committees, and the prioritizing of the applications for reappraising certain services cannot be changed from ‘outside’. The G-BA can be forced to act in a certain way from ‘outside’, but there is no other formal way of changing the priorities set by the G-BA. It can happen, like it is now the case with mammography, that pressure is coming from the political side. In the case of mammography screening it was the federal government who wanted it to be included in the benefit package of the SHI and who decreed the inclusion of mammography in the benefit package. The G-BA had no possibility of rejecting this decision as its regulating scope is overruled by federal law. The G-BA initiated pilot projects and experiments of mammogram screenings, but the federal government ignored them and did not wait for the evaluation of them.

Impact of the system for reimbursement decisions

Anything that is approved and decided by the G-BA has got – by its legal nature – a direct impact. There is unfortunately no research undertaken to evaluate what kind of impact HTA reports do have on the state of health of the patients concerned. It is a difficult undertaking in practice as so many known and unknown factors do have an influence on the health of a human being. The medical factor is always only

one factor amongst many. If we take for example the complexity of chronic pain and if we would like to investigate if an acupunctural treatment is releasing chronic neck or back pains, we would have to consider also all other factors that could have an impact on the chronic pain of a patient. This is (so far?) practically impossible.