The acceptance of basal implantology by German insurance companies and courts

The acceptance of basal implantology by German insurance companies and courts

Implantology is characterised by an enormous enthusiasm for innovation, the pace of which is generated by industry and science alike. Even in 2000, the highest German court in the area of state health insurance declared that implantology is a new science for which there are not yet any results regarding long-term effects. Since around 1990, a hitherto unseen number of reimbursement claims for previously little-known treatment plans including pre-implant bone augmentation measures have hit payors - namely the private health insurance companies, which cover about 10% of the German population.

For a long time - up until the decision by the German Federal Court of Justice (BGH) of 12/03/2003, to be precise - the insurance companies could still fall back on the argument that an implant constitutes a non-reimbursable luxury treatment if the provision of the implant-supported measure created an expense that was more than 3 times the cost of a conventional measure. "Conventional measures" referred to removable and mucosa-supported measures or measures using telescopic bridges. Since then, however, it no longer comes down to a cost comparison, i.e. if the policyholder chooses a disproportionately more expensive implant treatment and rejects less costly measures, the insurance company must accept this decision.

We can take from this situation that, these days, dental implantology is securely established within mainstream medicine and as such has been adequately scientifically proven. Moreover, treatment success sought can be reasonably expected and achieved in practice. Recently, the insurance industry has been trying to regain ground by basing its decisions on a risk comparison. Thus, a reimbursement claim would be rejected if upon weighing up properly understood patient interests one came to the conclusion that the treatment entails unacceptable risks in comparison with conventional treatment that is also feasible. A reimbursement obligation could thus be negated as a result of, to a certain extent, general considerations, even though the patient has already decided for the procedure after individual risk disclosure. This view, however, must be rejected, as it finds no support in the insurance contract and as it impedes the insurance contractual right to free choice of physician and treatment, and indeed is baseless, since cost reduction considerations on the part of the insurer are excluded from consideration.

The prevalence of the screw implant design at the beginning of the millennium was instrumental for the establishment of implantology in the face of resistance from payors and continues to have an impact to this day because subsequent case law refers to the earlier respective judgements. The economic success and ultimately the breakthrough of implantology helped to give this implant design a certain degree of recognition. Leading university professors have been and continue to be involved with this implant design through research contracts, cooperation agreements with the industry and, of course, through their own use of this design. In line with the slogan "never change a winning team", a group of implantologists focused on the protection of existing implantology against innovations and counter-proposals was formed. Science and the insurance industry, professional associations, and ultimately even industry only tolerated slight improvements of existing designs, which sometimes raised the question whether the further modification of the product actually had functional features or whether the change of design was simply chosen to simulate the progressiveness of the product.

In this situation, the Regional Court Saarbrücken found, on the basis of a favourable assessment by Prof. Riediger from Aachen, that a treatment by means of basal implants may be regarded as medically necessary, since such a treatment was in the meantime performed by a large number of dentists in Germany and was now also scientifically recognised in many academic circles. This treatment of basal implants as being comparable with screw type implants ended the unique position screw implants had enjoyed and brought about the emancipation of basal implantology.

During this stage of developments, basal implants were introduced to the market and promoted, particularly in the German-speaking world. This was preceded by positive experiences, particularly in France, Italy and Belgium. Basal implants were approved as medical devices and CE marked for their intended use throughout the European Union. However, this approval did not bring about immediate equal recognition of basal implants and screw implants, because both dental professional associations as well as many payors were of the view that general professional recognition of a basal implant could only be given after many years of testing and product monitoring. The costs of product development and the market launch as well as a further stage of product monitoring could have brought about a quick demise for this treatment approach. However, since 2003, the expert testimonies of Prof. Dr Neugebauer from Cologne have established that the basal implant, as a CE-marked implant, has successfully and promisingly met the the demands of practice, as its efficacy can be viewed as equal to that of approved conventional medical methods.

The categorical rejection and scathing criticism with which basal implants were met even before the end of the millennium was quite astonishing. Those who provided screw implant treatment were regularly asked to make decisions on the medical necessity of the use of basal implants for the courts. The fact that the screw implants themselves were still in the testing phase and that long-term monitoring of them was not yet available was not taken into consideration. It was also significant that such evaluators of basal implants would make their evaluations without ever having seen them, let alone ever having used them themselves. This view was held by the courts, since there was no right to a so-called internal evaluator, as long as the treatment in question was not part of mainstream medicine. In Germany, basal implants were still considered an outsider method as late as 2006. The breakthrough of basal implants and their recognition as mainstream medicine was prevented by the advocates of screw type implants for at least ten years.

But the segregation attempts of screw implantology, which was becoming established at the time, were directed not only against the basal dental implants as such, but - and possibly even principally - against immediate loading and immediate restoration about which the followers of basal implantology were at least open-minded. The legal appraisal of this treatment approach only began in 2003. Up to this point, the immediate loading or restoration of an implant was rejected across the board and, when evaluated by an expert, assessed as too risky and not scientifically proven.

A paradigm shift only began in 2004. It concerned the immediate restoration of basal implants for an upper jaw restoration that was to be certified as medically necessary. The appointed expert, Prof. Dr. Zöller from Cologne, a proponent of the process of bone distraction for the creation of sufficient bone bed for implantation, saw a significant advantage in basal implants in that they did away with the need for the bone grafting from the pelvic region that would otherwise be recommended. At the same time he realised that in the patient in question, the specific immediate restoration in situ had been successful. The Cologne Regional Court therefore introduced case law, according to which basal implantology must be regarded as equivalent to the screw implant. At the same time, with this decision, a successful implant-supported immediate restoration was given a positive assessment in a court for the first time. Basal implantology thus assisted in the advent of immediate loading and immediate restoration. Presumably, the approach taken by the advocates of screw implants, which aimed at segregation and stagnation, would not have been able to bring about the breakthrough of such an innovation. In the shadow of the breakthrough of basal implants, immediate loading and restoration became increasingly prevalent.

The case law, in particular from the District Court in Cologne, solidified into established case law, which also characterised basal implantology as mainstream medicine in the context of immediate loading and restoration. After an argument that had been going on for at least 10 years, the first legal battle was concluded in favour of basal implants. This case was widely published. It subsequently became noticeable that even supporters of screw type implants had to invoke this decision taken in connection with basal implants if they wanted to prove the admissibility of immediate loading and immediate restoration in court proceedings, even though immediate loading can and could be realised with only a very few screw implant types.

Since then, there has been legal certainty for patients and practitioners that the immediate restoration and loading of basal implants are recognized as mainstream medical treatments and that the payors would be obliged to reimburse the costs incurred for them. The past had shown how gravely payors have been able to interfere with the doctor-patient relationship, for example by alleging that the intended treatment was an outsider method lacking technical-scientific validation. Understandably, patients would revise their decision for this treatment once the refusal of reimbursement was signalled.

The advocates screw type implant now set about trying to change people's opinions. They published calls to arms against practitioners who carried out basal implants, by calling for the reporting of failed immediate restorations on basal implants in order to be able to use failed individual cases to be able to attack the method of basal implantology in general. The courts deemed such calls as unethical. Subsequently, warnings were issued about using this type of implant in general and individual cases of failed treatments were cited in support of this view, albeit these cases were not due to a shortcoming of the system but demonstrably due to the misapplication of the product by the implantologist. The facts underlying the call for caution had not even been sufficiently researched by the authors. As is well known, deviations from the standard of care also occur in the use of screw type implants, but this certainly cannot be used as evidence for the defectiveness of the product or even as an argument against implantology as such. Finally, general falsehoods about basal implants were produced and propagated in the scientific print media of the advocates of the screw implants. The best scientists from the screw implant supporters' camp did not feel any shame about invoking academic freedom in their defamation of basal implants. After the unscientific nature and inaccuracy of the allegations had been proved by judicial inquiry, the authors adopted the fall-back position that they only wanted to express their personal opinions, which could not be judged as right or wrong, as the utterances of a scientist should never be understood as statements of fact, but instead always stood under the protection of freedom of expression. Otherwise, they went on to say, a further development of science would be thwarted if any scientific theory were to be subject to injunctive relief requests from competitors or third parties. Yet in fact, it was precisely scientific progress that they wanted to prevent in appealing to academic freedom.

It turned out that in this conflict situation the scientific associations were either not willing or not able to confirm the medical acceptability of basal implantology or even to tolerate it within the context of a tolerance for scientific methods. Advocates of basal implants countered the general criticism raised with the stream of case law, which identified this type of implant as mainstream medicine. It was objected that this law was adopted on the basis of individual cases and could not make a general statement about the implant system as such. The paradox here was in fact that the warning against the system of basal implants was based on the analysis of five cases of treatment, hence it was also argued on a case-by-case basis. Scientific comparative studies between basal and conventional implants had never been carried out. It is likely that they would also be difficult to achieve, because, with regard to the two treatment options, fully informed study participants (patients) would never opt for traditional screw implants (incl. the bone augmentation and a healing time lasting months).

As to the quality of the analysis, it need only be observed that the individual cases were discussed without knowledge of treatment documentation and without consultation with the practitioner. These individuals exploited the fact that a desired publication in a professional journal often does not even have to meet those criteria, which in a court-appointed expert opinion would properly be required. The vast number of negative publications - even when signed by well-known university professors - proved quite simply to be wrong and their further distribution was prohibited quickly by German courts.

Specifically, the insight that there are no general implantology-related drawbacks to basal implants that would justify a less favourable assessment of the use of this implant type is owed to thorough expert assessment by Prof. Schmelzle from Hamburg. It was confirmed that the allegations were false, that in so doing a defamation had been perpetrated and that the scientists had committed significant violations of basic principles of methodology, with the ultimate aim of impeding a progressive-alternative treatment system that was gaining in self-confidence and of supporting the system of screw implants that they favoured. Once again, the state courts had to intervene to protect the development of basal implants, since neither dental science nor the scientific professional associations – the DGZMK (German Association of Dentistry) in particular – were prepared to mediate and bring about a settlement between the experts.

It would be desirable for these bodies to contribute actively to the implementation of existing case law in favour of basal implants. It is an intolerable contradiction that case law should certify a method of treatment as mainstream medicine whilst a professional association calls into question its long-term safety - unlike with all other implant systems. The DGZMK itself has established the standard that scientific opinions must be updated at least once every 5 years, precisely in order to be open to current findings and to incorporate them into a position statement. Nevertheless, a statement from 2000 continues to be upheld, the year in which the highest German Social Court found that a long-term justification for implantology as such did not exist, according to which no long-term studies on basal implants were available. For many years, this statement was of critical importance for payors looking to answer the question as to whether or not costs are to be reimbursed in specific cases or not. In 2010, a modification of this opinion was requested again after a suggestion relating to this matter was rejected in 2005.

It can already be observed that the pre-implant information for the patient must also make reference to the possibility of restoration based on basal implant, either in the case of the restoration of a highly atrophied upper jaw, which would otherwise first need to be augmented, or if there is the risk of individual nerve damage due to the proximity of the nerves in the mandible. Today, it would no longer be acceptable not to mention the basal implant in the context of patient information or to fail to mention the fact that when using this implant a transplant operation can often be avoided and that it only requires one surgical site, indeed that it can be said generally to be gentler than the implantation of a screw into a bone graft. In any event, the patient must also be informed of the fact that immediate loading and immediate restoration has been deemed suitable for this type of implant. Special obligations regarding information and advice arise with patients who smoke, because in their case the pre-implant bone augmentation measures are associated with particular risks. These patients must absolutely be alerted to the fact that there is a treatment method using basal implantology whereby highly risky bone augmentation can be avoided. In light of this, it is all the more surprising that bone augmentation measures for smokers continue to be subsidized by health insurers.