DGAO statements concerning the (German) Dental Fee Schedule draft legislation from 24 March 2011

The following statement concerning the proposed legislation is made from the perspective of aligner orthodontics, its users and patients. Here, the focus is on the observation that aligner orthodontics involves a "new" procedure within the meaning of Art. 6, s. 2 (German) Dental Fee Schedule, which has been only recognised in the Federal Republic of Germany as having become ready to be used since 2001 and since at least 2006 as conventional medicine, i.e., after the effective date of the current (German) Dental Fee Schedule on 22 October 1987. It is considered one the best documented dental procedures, with approx. 1.5 million patients treated alone to date. In comparison conventional, multi-band treatment ("braces"), this procedure has been inadequately and ambiguously accounted for in the draft legislation. It appears, therefore, that the draft legislation needs urgently to be amended.

At the outset, it is important to recognise that the (German) Dental Fee Schedule in its current version does not include statutory requirements for billing of aligner orthodontics. The draft legislation submitted proposes only a single textual insertion regarding the dental fee within the framework of orthodontic treatment in accordance with the (German) Dental Fee Schedule 6080 at the end, as follows:

"The measures referred to in subsections 6030 to 6080 include all services for reshaping of the jaw and retention or for adjustment of the mandible to the normal occlusion regardless of the methods of treatment used (e.g., incorporation, activation and/or removal of loops, arches, attachments with aligners or fixed retainers) or the therapeutic devices used (e.g. including plastic splints)."

Otherwise, the proposed changes and additions to section G involve editorial changes and clarifications concerning billing for the material and laboratory costs of orthodontic treatment.

I. Revision or clarification of the existing legislation

Hence, particularly in consideration of the justification for the draft legislation, it remains uncertain if the legislature wants to regulate or only to clarify by the insertion of the text passage at the end of item 6080. The wording of the justification of the draft legislation speaks in favour of the latter, that the (known) services of numbers 6030 to 6080 will be "specified". So, the legislature has merely explained the existing regulations without wanting to change the regulatory content itself. This is confirmed by the fact that the legislature intends to avoid textually amending, supplementing or adding new service codes for claims to the service items themselves. In the draft legislation, such changes to the (German) Dental Fee Schedule service items concern the field of preventative, preservative and implantology services, while a regulatory intent becomes apparent in the field of orthodontic services only in terms of the stipulation of additional costs. Further, the only other textual addition to 6160 (for the material and laboratory costs included in the fee) also contains merely clarifying content with no regulatory content.

Those who pay will tend to understand the questionable wording of the draft legislation as regulation, which no longer justifies reimbursing the introduction of attachments for aligners in analogous application of item 6100 in the future. The analogous settlement for the mounting of attachments according to the inclusion of an bonded braces in accordance with item 610 of the (German) Dental Fee Schedule is currently common practice, which has been confirmed by expertly advised, established case law. This billing practice would be questioned in the future by the payer. Since the use of plastic attachments is necessary for virtually any treatment with aligners and represents its own special service, such a signification portion of the expenses as part of aligner therapy would simply be withdrawn from the clear criteria against which invoices will be able to be issued in the future.

It seems questionable whether the authors of the draft legislation, who only wanted to describe the service content of the existing service items, were themselves aware of the effect that payers may not just raise a claim against the questionable wording as a billing barrier for major treatment features, but also against the new aligner therapy. On the basis of the reasoning of the draft legislation, it stands more to reason that a regulatory impact in terms of a billing block was not intended at all for the newly developed aligner technique and the possible regulatory impact of its explanations remained hidden from the legislature. Therefore, the deletion of the words "attachments for aligners" would be required in the draft. In addition, this should apply to all other lists mentioned here (incorporation, activation and/or removal of loops, arches or fixed retainers), which contribute to misunderstanding in the same manner.

II. Inadequate regulation of aligner orthodontics

The draft legislation does not implement the mandate contained in the coalition agreement, “to adapt the (German) Dental Fee Schedule (GOZ) to the state of scientific knowledge and, at the same time, to take cost developments into consideration”. This objective, formulated as a political postulate, also arises as an immediate result of the statutory provision of Art. 6 of the (German) Dental Fee Schedule, according to which, newly developed and practised treatment approaches should be invoiced through an appropriate use of the existing (German) Dental Fee Schedule service items. Likewise, the legislature is obliged, where an act is amended, to accommodate the accounting regulations to scientific and dental advances (as was the case, for example for the introduction of item 900, once dental implantology had emancipated itself as a constituent part of conventional medicine).

By a single reference to an aligner therapeutic device in a list of examples alone and in a parenthetical addition, without a concrete billing item, it should not be assumed that the treatment approach as such has been included and incorporated at all by the legislature. In view of the future billing of aligner orthodontics, the draft legislation instead creates uncertainty as to whether the present analogous billing will continue to apply or even whether the omitted consideration for this treatment approach in a separate service item suggests that in the future (in the absence of explicit provision), these orthodontic measures will be billable neither directly nor analogously.

III. No requirement for regulation for the fragmentary provision enacted

There was no requirement for regulation for the inclusion at the end of item 6080. In its justification, the draft legislation states that the inclusion was made “in order to avoid the occurrence of ambiguities in practice”. Ambiguities of this kind may have occurred in the billing for the other treatment approaches addressed. Since at least 2006, it has been clarified that the billing of aligner treatment concerns an established, new procedure, which should be billed in analogous application of the (German) Dental Fee Schedule. On this basis, a billing practice was established, which was more precisely refined by case law. Consequently, the ambiguities addressed in the justification for the draft legislation do not concern aligner orthodontics.

Nor do the cost aspects addressed in the coalition agreement require the inclusion referred to: orthodontic treatment with aligners does not regularly result in costs higher than treatment with the customary braces. It should be emphasised that this is the case even if the insertion of the attachments – as is currently customary – is billed analogously to item 610 of the (German) Dental Fee Schedule. Hence, these treatment costs for aligner treatment in minors were viewed in case law as necessary and economically reasonable expenditures within the meaning of Art. 6, s. 1 of the (German) Federal Benefits Regulation. In the final analysis, therefore, the aligner technique also qualifies for benefit from a cost effectiveness point of view of the statutory sickness insurance in accordance with Art. 28, s. 2, subs. 5 of the (German) Social Security Regulation.

IV. Undesirable regulatory effects

Ultimately, regulatory effects are to be expected which will not be borne by the objectives of the draft legislation, but which run counter to them:

The implementation of the draft would result in the innovative aligner technique being, from a billing point of view, more poorly positioned than the conventional, multi-band treatment (“braces”). In order to clarify the economic appropriateness of the aligner technique, cost comparisons of both treatment approaches were carried out by the benefits offices and the administrative courts, which verify the result, given the hitherto valid premise, that there is no difference in cost between the two techniques and that both variations of bonding the braces or the attachments can be billed via (German) Dental Fee Schedule 610. If this billing were to be withdrawn from users of the aligner technique in the future, the legislature would have set remuneration incentives to the disadvantage of this innovative technique. This would not be compatible with its intention of integrating innovative methods adequately into the billing system.

Furthermore, the regulatory target of the draft, preventing double billing by highlighting the target performance principle, would be missed. As the cost comparison shows directly, the emancipation of the innovative aligner technique in the market led to a cost adjustment to the conventional multi-band technique. To the extent that the aligner technique is affected, undesirable double billing has neither been brought to light nor is it to be feared, such that this regulatory objective cannot justify the questionable inclusion, either. If anything, it even seems contrary to the system, that the legislature, by its subsequent configuration of the service items, is impinging on the competition between methods.

V. Proposed amendment

From the point of view of aligner orthodontics, its users and patients, the draft legislation presented is a scrappy, ambiguous regulatory stump. The most clarity would be achieved if aligner orthodontics were not addressed at all (by the deletion of the words “attachments for aligners”) and thus by leaving it in the current, safe legal position.

Moreover, the deletion of the general provision from item 6000 of the (German) Dental Fee Schedule, on the standard materials covered, is encouraged. A provision for additional costs of this type in private liquidation law is an obvious break with the system and promotes neither the transparency of the billing nor brings about an increase in consumer protection. Above all, the bearers of the cost in the future will always want to restrict reimbursement to the cheapest materials, which the guideline does not take into account, that the privately insured patient should also then be able to decide freely among several therapeutic options if there is a difference in cost.

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