Judgment of 26 March 2015 -
BVerwG 5 C 9.14ECLI:DE:BVerwG:2015:260315U5C9.14.0


Please note that the official language of proceedings brought before the Federal Administrative Court of Germany, including its decisions, is German. This translation is based on an abbreviated version of the original decision. It is provided for the reader’s convenience and information only. Please note that only the German version is authoritative. Page numbers in citations have been retained from the original and may not match the pagination in the English version of the cited text.
When citing this decision it is recommended to indicate the court, the date of the decision, the case number and the paragraph: BVerwG, Judgment of 26 March 2015 - BVerwG 5 C 9.14– para. 16.

Headnote

The eligibility of medical devices is effectively restricted by section 22 second sentence of the Ordinance on the Health Allowance Scheme for Civil Servants of the Federal State of Berlin (Landesbeihilfeverordnung Berlin, LBhVO BE). The two-stage reference to section 31 (1) second sentence of the Social Code Book V (Sozialgesetzbuch V, SGB V) and the provisions provided in the German Medicinal Products Directive (Arzneimittel-Richtlinie) issued by the Joint Federal Committee (Gemeinsamer Bundesausschuss) regarding medical devices does not violate constitutional law. It is in particular compatible with the principle of the requirement of the specific enactment of a statute (Vorbehalt des Gesetzes).

  • Sources of law
    Basic Law for the Federal Republic of Germany GG, Grundgesetz article 2 (1), article 20 (1) and (3), article 28 (1) first sentence, article 33 (5), article 80 (1) second sentence
    Civil Service Law Framework Act BRRG, Beamtenrechtsrahmengesetz section 127 no. 2
    Act on the Status of Civil Servants BStG, Beamtenstatusgesetz section 45, section 63 (3) second sentence
    Social Code Book V SGB V, Sozialgesetzbuch V section 31 (1) second and third sentence, section 91 (1) first sentence, section 92 (1) second sentence no. 6, section 93 (1) second sentence, section 94 (2)
    Law on Civil Servants of the Federal State of BerlinBeamtengesetz des Landes Berlin section 76 (11)
    Ordinance on the Granting of Assistance Under the Health Allowance Scheme for Civil Servants in the Case of Illness, Care Dependence, Childbirth, and Other Cases (Ordinance on the Health Allowance Scheme for Civil Servants of the Federal State of Berlin) LBhVO, Verordnung über die Gewährung von Beihilfen in Krankheits-, Pflege-, Geburts- und sonstigen Fällen (Landesbeihilfeverordnung Berlin) section 22 first and second sentence, section 7 second sentence, section 6 (1)

Summary of the facts

The parties are in dispute about the eligibility of a medical device for assistance under the health allowance scheme for civil servants (hereinafter: health allowance scheme) on the basis of the Ordinance on the Health Allowance Scheme for Civil Servants of the Federal State of Berlin.

The claimant is a retired civil servant of the defendant and, as such, receives assistance under the health allowance scheme in the amount of 70 % of her expenses incurred due to illness. In the context of the medical treatment for osteoarthritis of both knees with hyaluronic acid, invoices dated 16 February 2010 for expenditures for five “Ostenil pre-filled syringes” in the amount of EUR 437 had been issued to her. In March 2010, she filed an application for assistance under the health allowance scheme, seeking the granting of assistance with respect to these invoices, among others.

The defendant refused to provide assistance under the health allowance scheme on the basis that hyaluronic acid preparations were generally not subject to any prescription requirements and, therefore, not reimbursable. The claimant lodged an objection (Widerspruch) against this decision, which the defendant rejected, noting that “Ostenil” was a medical device which, pursuant to the applicable directive issued by the Federal Joint Committee (Gemeinsamer Bundesausschuss) which concerns the provision of medicinal products, was not reimbursable. The claimant thereupon lodged an action and the Administrative Court found against her.

The Higher Administrative Court granted the appeal which the claimant had lodged against this and ordered the defendant to grant the claimant further assistance under the health allowance scheme in the amount of EUR 305.90.

Reasons (abridged)

7 The defendant’s appeal is well-founded. The judgment of the Higher Administrative Court violates federal law (section 137 (1) no. 1 of the Code of Administrative Court Procedure (VwGO, Verwaltungsgerichtsordnung), section 127 no. 2 of the Civil Service Law Framework Act (BRRG, Beamtenrechtsrahmengesetz) (in conjunction with section 63 (3) second sentence of the Act on the Status of Civil Servants - BStG, Beamtenstatusgesetz)). The Higher Administrative Court improperly proceeded on the assumption that the provision on the eligibility for assistance of expenditures incurred for medical devices under the health allowance scheme (section 22 second sentence of the Ordinance on the Granting of Assistance Under the Health Allowance Scheme for Civil Servants in the Case of Illness, Care Dependence, Childbirth, and Other Cases < Ordinance on the Health Allowance Scheme for Civil Servants of the Federal State of Berlin (LBhVO BE, Landesbeihilfeverordnung Berlin)> of 8 September 2009 <Law and Ordinance Gazette (GVBl., Gesetz- und Verordnungsblatt Berlin) p. 436> in the version of the First Regulation Amending the Ordinance on the Health Allowance Scheme for Civil Servants of the Federal State of Berlin of 8 May 2012 <GVBl. p. 138>, which came, retroactively, into effect as of 1 January 2010) was void because of a violation of the principle of the requirement of a specific enactment of a statute (Vorbehalt des Gesetzes), of the principle of precision (Bestimmtheitsgebot), and the constitutional principle that the state has the duty to have due regard for the welfare of its civil servants (Fürsorgegrundsatz).

8 (…) This provision contains a special rule as to medical devices that is applicable here (1.) and as to the validity of which there exist no well-founded doubts (2). Neither is the claimant entitled to assistance under the health allowance scheme pursuant to aspects relating to a case of hardship (3.).

9 1. Due to their purely physical mode of action on joint diseases, remedies containing hyaluronic acid, such as, e.g., the “Ostenil pre-filled syringes” which are at issue here, have to be regarded as medical devices (Medizinprodukte) (...) and not as medicinal products in the sense of pharmaceuticals (Arzneimittel) (…) (cf. Federal Administrative Court, (BVerwG, Bundesverwaltungsgericht) judgment of 12 September 2013 - 5 C 33.12 - Rulings of the Federal Administrative Court (BVerwGE, Entscheidungen des Bundesverwaltungsgericht) 148, 1 para. 22 with further references).

10 The Higher Administrative Court is ultimately correct in holding that expenditures for medical devices are on principle only then eligible for assistance under the health allowance scheme - pursuant to section 22 second sentence LBhVO BE in conjunction with section 31 (1) second and third sentence of the Social Code Book V (SGB V, Sozialgesetzbuch V) - Statutory Health Insurance - of 20 December 1988 (Federal Law Gazette (BGBl., Bundesgesetzblatt) I p. 2477) - applicable here in the version in force at the relevant time as amended by the Law of 16 May 2008 (BGBl. I p. 842, 847) - if they are listed in annex V to the Directives issued by the Federal Joint Committee based on section 92 (1) second sentence no. 6 of the SGB V (German Medicinal Products Directive, AM-RL, Arzneimittelrichtlinie) (a). Because the “Ostenil pre-filled syringes” which are at issue here are not listed therein, any expenditure incurred for them is not eligible for assistance under the health allowance scheme (b).

11 a) As a special provision with respect to the eligibility of medical devices for assistance under the health allowance scheme, the provision of section 22 second sentence LBhVO BE prevails within its scope of applicability - this is not something which is at issue between the parties - over both the provision on medicinal products (section 22 first sentence LBhVO BE) as well as over the general provision of section 6 (1) LBhVO BE. This is because section 22 first sentence LBhVO BE itself contains, in turn, a reference to an analogous application of section (1) second and third sentence of the SGB V, which contains a special provision for medical devices in the context of the statutory health insurance. According to this provision, the Joint Federal Committee has to determine - in its directives issued pursuant to section 92 (1) second sentence no. 6 SGB V - in which medically necessary cases substances and preparations derived from substances which are determined to be used on or in the human body as medical devices pursuant to section 3 no. 1 or no. 2 of the Act on Medical Devices (MPG, Medizinproduktegesetz) are eligible to be included in the provision of medicinal products on an exceptional basis. According to section 27 (1) first sentence of the Directive of the Joint Federal Committee on the Prescription of Medicinal Products in the Context of the Provision by Physicians Enrolled in the Statutory Health Insurance Scheme (German Medicinal Products Directive, Richtlinie des Gemeinsamen Bundesausschusses über die Verordnung von Arzneimitteln in der vertragsärztlichen Versorgung) of 18 December 2008 / 22 January 2009 (Federal Gazette(BAnz, Bundesanzeiger) 2009, No. 49a), medical devices are generally excluded from the provision of medicinal products. Section 27 (1) second sentence of the German Medicinal Products Directive excludes only those medical devices from this principle which are, in medically necessary cases, included on an exceptional basis in the provision of medicinal products in accordance with said Directive. The medical devices to which this applies are listed exhaustively in section 27 (8) first sentence of the German Medicinal Products Directive in an overview that is attached as annex V to the Directive.

12 section 22 second sentence LBhVO BE therefore contains, as the Higher Administrative Court correctly explains, a two-stage dynamic reference. Initially, the norm refers, at a first stage, directly to the social security provision contained in section 31 (1) first and third sentence SGB V. Because that norm contains yet another reference, this means that section 22 second sentence LBhVO BE also indirectly refers - at a second stage, in a manner of speaking - to the provisions in the directives issued by the Joint Federal Committee pursuant to section 92 (1) second sentence no. 6 SGB V (German Medicinal Products Directive), which, in turn, makes reference to section 31 (1) second sentence SGB V. To this extent, the reference is to be interpreted broadly. Section 22 second sentence LBhVO BE refers at that second stage not only to the abstract principles laid down in the German Medicinal Products Directive regarding the prescribability of medical devices in sections 27 through 29 of this Directive, but it also refers to the medical devices which were specifically recognised as being prescribable by the Joint Federal Committee in accordance with the procedure laid down for that purpose, and which are exhaustively listed in annex V to the German Medicinal Products Directive pursuant to section 27 (8) first sentence of this Directive. (...)

15 b) In view of this, the expenditures for the “Ostenil pre-filled syringes” which are at issue here are not eligible for assistance under the health allowance scheme. (...)

16 2. Contrary to the opinion of the Higher Administrative Court, the regulator has effectively excluded the eligibility of the medical devices listed in annex V of the German Medicinal Products Directive by means of section 22 second sentence LBhVO BE for assistance.

17 a) section 22 second sentence LBhVO BE complies with the prerequisites of the principle of the requirement of a specific enactment of a statute (Vorbehalt des Gesetzes).

18 This principle - which proceeds from the rule of law and democracy of the constitutional system established by the Basic Law (GG, Grundgesetz) (article 20 (1) and (3) GG) and which is, in any event by virtue of the requirement of homogeneity (article 28 (1) first sentence GG), also binding upon the legislation at federal state level - requires that government action in certain fundamental normative areas must be legitimised by a formal law. The parliamentary legislator is obliged to make all decisions on its own and is not permitted to leave it to other legislative bodies or to the administrative procedure. As to the determination of the question in which cases it is necessary, in accordance with the foregoing, that a rule has to be adopted by the parliamentary legislator, this can only be assessed with respect to each particular area and the characteristic features of the respective matter which needs to be regulated (BVerwG, judgment of 19 July 2012 - 5 C 1.12 - BVerwGE 143, 363 (…) para.12 with further references).

19 According to the jurisprudence of the Federal Administrative Court, the principle of the requirement of a specific enactment of a statute (Vorbehalt des Gesetzes) applies also to the law on assistance under the health allowance scheme. In the scope of its constitutional possibilities, the parliamentary legislator has to lay down the health allowance scheme which provides civil servants and their families with protection in case of illness or dependency on care. Furthermore, the parliamentary legislator has to assume the responsibility for significant restrictions with respect to the standard of assistance provided under this health allowance scheme. Otherwise, the executive branch would be able to unilaterally impair - by virtue of cancellations and reductions of the assistance under the health allowance scheme - the maintenance level that had been established in the laws on remuneration and maintenance of civil servants. Even if the combined system as it is currently practiced, which consists of privately financed health care provision and supplementary health allowance, does not form part of the traditional principles of the professional civil service and, consequently, is not guaranteed under article 33 (5) of the Basic Law, at least the decision as to under which circumstances support in the form of assistance has to be denied in its entirety is of a fundamental nature and as such, consequently, has to be made by the parliamentary legislator itself (BVerwG, judgments of 10 October 2013 – 5 C 29.12 - BVerwGE 148, 116 para. 14 and of 19 July 2012 – 5 C 1.12 - BVerwGE 143, 363 para. 13 with further references). Conversely, the prerequisites imposed by the principle of the requirement of a specific enactment of a statute (Vorbehalt des Gesetzes) are lower insofar as restrictions on the assistance are merely specified by the regulator, when such restrictions have - as, e.g., the restriction on the assistance with respect to medical devices - already been laid out in the law on assistance under the health allowance scheme (as to the transitional law, see BVerwG, judgment of 10 October 2013 – 5 C 29.12 - BVerwGE 148, 116 para. 28). The same applies when there is a subject matter or an assistance category within the health allowance scheme involved - and this is equally applicable to assistance for medical devices - whose significance for the beneficiaries entitled to receive assistance under the health allowance scheme cannot be deemed to be of great importance.

20 In view of this, the restriction on the eligibility of medical devices for assistance under the health allowance scheme to that standard which applies in the statutory health insurance, which restriction is laid down in section 22 second sentence LBhVO BE, is compatible with the principle of the requirement of a specific enactment of a statute. This regulatory provision is founded on a basis of authorisation which is sufficiently precise (aa) and is - based on an assessment made in line with the abovementioned standards - still compatible with the specific requirements imposed on dynamic references by the principle of the rule of law and the principle of democracy (bb).

21 aa) As to the necessity to issue a decision for which it bears the responsibility, the legislator may, in principle, also fulfil this obligation by virtue of authorising the administration to regulate the exclusion of the assistance by means of an ordinance enacted by the federal state. To that end, it is necessary that federal state law contains an authorisation for the adoption of ordinances which is sufficiently specific by the standards of the principle of precision (Bestimmtheitsgebot) which proceeds from article 80 (1) second sentence of the Basic Law and which has to be observed by the federal state legislator as well, and that said authorisation covers the exclusion of assistance in question in terms of content (BVerwG, judgment of 19 July 2012 - 5 C 1.12 - BVerwGE 143, 363 para. 15, with reference to Federal Constitutional Court (BVerfG, Bundesverfassungsgericht), decision of 13 September 2005 – 2 BvF 2/03 - Entscheidungen des Bundesverfassungsgerichts (BVerfGE, Rulings of the Federal Constitutional Court) 114, 196 <238>).

22 section 76 (11) of the Law on Civil Servants of the Federal State of Berlin in the version of 19 March 2009 (GVBl. p. 70) complies with these requirements, as this provision authorises the administration to regulate the exclusion, in whole or in part, of medicinal products, remedies, and therapeutic appliances from being granted assistance under the health allowance scheme by virtue of a statutory regulation following the lines of the Social Code Book V. (...)

23 (bb) Furthermore, the dynamic reference contained in section 22 second sentence LBhVO BE to section 31 (1) second and third sentence SGB V, and the German Medicinal Products Directive, which is, in turn, referred to therein and which has to be enacted by the Joint Federal Committee, also still meets (...) the specific requirements established by the principle of the rule of law and the principle of democracy, which have to be imposed in the context of the principle of the requirement of a specific enactment of a statute on any dynamic references to rules issued by third parties (such as the Joint Federal Committee).

24 (1) It is true that it may give rise to constitutional concerns when the decision-making power about the recognition of the eligibility of (medical) devices for assistance under the health allowance scheme is transferred to the Joint Federal Committee, which, pursuant to section 91 (1) first sentence SGB V consists of the National Association of Statutory Health Insurance Physicians, the German Hospital Federation, and the National Association of Statutory Health Insurance Funds. Such concerns may arise in particular with regard to the systemic difference between the health allowance scheme on the one hand and statutory health insurance on the other hand. Such concerns might obligate the legislator to make the detailed determination as to any exclusions of benefits itself, rather than leaving the decision to a panel like the Joint Federal Committee, in which the state as an employer is not represented and which is a committee which makes its decisions not by the standards of the constitutionally guaranteed duty of the state to have due regard for the welfare of its civil servants, but rather as a self-governing body of various insurance communities organised as public bodies to protect the interests of such public bodies (BVerwG, judgments of 28 May 2008 - 2 C 24.07 - of 6 November 2009 - 2 C 60.08 - juris para. 24 as well as 12 September 2013 – 5 C 33.12 - BVerwGE 148, 1<9>).

25 (2) However, dynamic references of the kind mentioned above are not automatically inadmissible from the outset. Pursuant to the jurisprudence of the Federal Administrative Court, it is settled that a legislative body is allowed to refer to rules of other legislative bodies and not merely to its own rules. Moreover, references to other sets of rules that were created by non-governmental standardisation bodies are not generally inadmissible, as long as it is clearly discernible for the persons subject to them which provisions shall apply to them in detail (BVerwG, judgment of 27 June 2013 – 3 C 21.12 - BVerwGE 147, 100 para. 39). However, this may not be implemented in a manner which results in citizens finding themselves at the mercy of a body which has the power to lay down rules in an unfettered way, and whose legitimisation as against the citizen is based neither on the government, nor on membership. This would be contrary to the principle of the rule of law, according to which any restrictions on the freedom of the citizen, insofar as such restrictions are admissible in the first place, may exclusively be implemented by or pursuant to state laws, and it would be contrary to the principle of democracy, according to which the regulation of areas of life which, pursuant to the Basic Law, are amenable to governmental regulation have to be traced back to a voluntary decision on the part of the legislative bodies which were democratically appointed by the people. It is only to the extent to which the contents of the rules enacted by a private party, which are then referred to by provisions of state legislation, are determined in terms of their essence that the referring provision meets the requirements that proceed from article 2 (1) of the Basic Law in conjunction with the principle of the rule of law and the principle of democracy. The answer to the question whether these legal boundaries, which were set to such a dynamic reference on account of the constitution, have been complied with depends on the subject matter and the relevance to basic rights associated therewith, and beyond this, it depends, essentially, on the scope of the reference (established jurisprudence, see BVerwG, judgment of 27 June 2013 – 3 C 21.12 - BVerwGE 147, 100 para. 42 et seq. with reference to BVerfG, decision of 25 February 1988 – 2 BvL 26/84 - BVerfGE 78, 32 and judgment of 14 June 1983 – 2 BvR 488/80 - BVerfGE 64, 208). Thus, dynamic references are generally admissible when the scope allotted to the reference is “narrow”. When the reference in question has a narrow range, it can be assumed that the referring regulator will be able to keep an eye on the regulations referred to, so that it may react immediately to any amendments which exceed the prescribed framework or which are undesirable to it (BVerwG, judgment of 27 June 2013 - 3 C 21.12 - BVerwGE 147, 100 para. 44). The dynamic reference contained in section 22 second sentence LBhVO BE still meets the abovementioned requirements.

26 (a) Changes in legislation regarding the Social Code Book V comply with the publicity requirement under the rule of law as they are published in the Federal Law Gazette, and, with respect to the enactment of the German Medicinal Products Directive, in the Federal Gazette and the internet, pursuant to section 93 (1) second sentence, section 94 (2) SGB V.

27 (b) The restriction as to the scope of the reference, which is required under both the principle of the rule of law as well as the principle of democracy, may be taken account of in terms of quantity, but also in terms of quality, by means of a limitation of the referred norms, in the manner that the regulator limits their binding character, prescribing and/or granting the administration its own rules and a margin for action within the context of their application of such norms. In section 7 LBhVO BE, which contains limitations that the state acting as employer has to take into account when applying the referred norms, the regulator did prescribe such a limitation in terms of quality with respect to references to provisions of the Social Code Book V.

28 This applies, on the one hand, to section 7 first sentence LBhVO BE, which subjects the eligibility for assistance under the health allowance scheme which is based on the Social Code Book V to the following conditions: the generally recognised state of medical knowledge regarding the diagnostic and therapeutic benefits along with the medical necessity and the reasonableness must have been proven, furthermore, they have to be appropriate, and any other reasonable treatment method which offers a comparable diagnostic and therapeutic benefit must be unavailable. Through this, principles regarding the prescribability which originate from the law of statutory health insurance are being incorporated - in an autonomous and modified manner - into the law on assistance under the health allowance scheme. This leads to the effect that, as the case may be, amendments to the Social Code Book V may not necessarily automatically affect the law on assistance under the health allowance scheme. Consequently, the dynamic effect of the references is at least in this respect partially disrupted.

29 On the other hand, section 7 second sentence LBhVO BE contains a significant qualitative restriction of the scope of the references to the German Medicinal Products Directive. This provision prescribes that in case of the application of law - when dealing with references to directives and decisions issued by the Joint Federal Committee - while taking into account the principle that the state has the duty to have due regard for the welfare of its civil servants pursuant to section 45 BStG - only the principles laid down in such norms or decisions have to be considered. The wording is far from being precise. Nevertheless, it is, at the very least, possible to interpret the provision with regard to its content and rationale which is that the employer and the agency responsible for determining the amount of the assistance both retain the “ultimate competence” to decide on the eligibility for assistance under the health allowance scheme in keeping with the principle that the state has the duty to have due regard for the welfare of its civil servants, thus ensuring that the dynamic reference is constitutional (see Parliament of Berlin - Printed Records 16/2631, ordinance no. 16/190 p. 92). Therefore it can be derived, that the norms which are referred to apply only on principle and that, when they are applied, the principle that the state has the duty to have due regard for the welfare of its civil servants pursuant to article 33 (5) of the Basic Law has to be taken into account.

30 In spite of its indeterminate character, the qualitative restriction of the reference in section 22 second sentence LBhVO BE to the Social Code Book V and the directives of the Joint Federal Committee by section 7 second sentence LBhVO BE still meets the requirements which have to be imposed to dynamic references to any third-party norms. This rule offers the employer a margin for assessment and discretion - provided that principles relating to the law on the civil service are taken into consideration - and guarantees that assistance for expenditures incurred for medical devices is provided under the health allowance scheme at least in those cases where this is required pursuant to the constitutional principle that the state has the duty to have due regard for the welfare of its civil servants. Conversely, although there is an interference with the previous standard of assistance under the health allowance scheme, which is connected to the general exclusion but the exceptional eligibility of medical devices under the health allowance scheme through section 22 second sentence LBhOV BE, this interference is of low intensity and represents, in terms of its nature, rather a specific expression of the scope of assistance which was already granted.

31 Moreover, the constitutional duty according to which a state must have due regard for the welfare of its civil servants does not require that any and all expenditures incurred in the event of illness are completely and consistently reimbursed. Therefore, the regulator is generally permitted to exclude the reimbursement of costs for medical devices as long as a medically appropriate and adequate care in the event of illness is guaranteed and as long as it does not fall short of the standard of what is medically required (see BVerwG, judgment of 13 December 2012 – 5 C 3.12 - (…)).

32 b) Contrary to the opinion of the Higher Administrative Court, the partial exclusion of expenditures for medical devices in section 22 second sentence LBhVO BE does not constitute a violation of the principle that the state has the duty to have due regard for the welfare of its civil servants pursuant to article 33 (5) of the Basic Law because of the absence of a precise, general, and abstract hardship case rule, either. (...)

35 bb) Contrary to the opinion of the Higher Administrative Court, at least section 7 second sentence LBhVO BE contains a sufficiently precise hardship case rule, to the extent to which said provision prescribes that the principle that the state has the duty to have due regard for the welfare of its civil servants pursuant to section 45 BStG has to be taken into consideration in the context of the application of the referred directives of the Joint Federal Committee. It thereby establishes the opportunity of constitutionally required deviations from the regulations of the Joint Federal Committee (see Parliament of Berlin - printed papers (Abgeordneten-Drucksache) 16/2631, ordinance no. 16/190 p. 93).

36 On the one hand, section 7 second sentence LBhVO BE thereby reflects the principle that - irrespective of the exhaustive nature of the provisions relating to assistance under the health allowance scheme - the constitutionally guaranteed duty of the state to have due regard for the welfare of its civil servants may be relied on directly as a basis for a claim for remuneration if, otherwise, it would mean that an undue burden is imposed on the civil servant even if one takes into consideration that the provisions relating to the assistance under the health allowance scheme are of a standardising and generalising nature, and that the refusal to grant assistance under the health allowance scheme violates the essential core of the duty of the state to have due regard for the welfare of its civil servants. (...)

37 On the other hand, section 7 second sentence LBhVO BE does not only amount to a reference to the principle that the state has the duty to have due regard for the welfare of its civil servants, but it allows for the compensation for hardship cases even in cases in which the core area of this duty is not affected. Accordingly, it is sufficient when, in an individual case, there exist circumstances with regard to which it becomes self-evident that this principle will lead to an exceptional recognition of the eligibility of the assistance under the health allowance scheme in this case, the inclusion of a medical device.

38 3. The claimant also has no entitlement to receive the requested assistance under the health allowance scheme on the basis of the hardship case rule of section 7 second sentence LBhVO BE. (…)