3.1 Reimbursement
As we could see above, one of the central elements of the directive is the manda-tory reimbursement by the insurance company of a certain proportion of the costs incurred during using healthcare services in another member state. First of all, it should be pointed out that regarding this reimbursement, what is meant here is the expressis verbis stipulation of eligibility on the one hand, and making the procedure of such reimbursement clearer and more transparent, on the other hand. Of course, the eligibility to reimbursement arises from the case law of the Court but declaring it in a directive undoubtedly contributes to applying the law uniformly. Besides the regulation mechanism, the directive puts a new mecha-nism into effect, which is based on the provisions of the Treaty on free move-ment. This mechanism allows the patient to use healthcare services in another member state if they are also eligible to this in the member state of affiliation, and the costs of these to be reimbursed by the insurance company up to the level of costs that would have been incurred if the treatment had been received at home (Par. 4, Article 7).
Paragraph (4), Article 7 of the directive provides that ‘The costs of cross-bor-der healthcare shall be reimbursed or paid directly by the Member State of affiliation up to the level of costs that would have been assumed by the Member State of affiliation, had this healthcare been provided in its territory without ex-ceeding the actual costs of healthcare received.’ This wording reflects the princi-ple laid down in the Vanbraekel case489, according to which a supplementary
re-489 The Vanbraekel case No. C–368/98 [2001] ECR I–5363. According to the facts of the case, Mrs.
Descamps, who was insured by Belgian social security, applied for authorization to her own health insurance fund for the performance of an orthopedic surgery in France. The Belgian authorities re -fused the application filed by Mrs. Descamps because the intervention had not been commented on by a specialist of a Belgian clinic. After she had received treatment in France, without having been granted prior authorization, Mrs. Descamps returned to Belgium and lodged a successful appeal to the Belgian court. They consulted the European Court of Justice for deciding the extent of the reim-bursement, i.e. whether the treatment should be reimbursed by applying French or Belgian tariffs.
According to form No. E 112, the insured person should have been reimbursed on the basis of the rates applied in France (38 thousand French Franks), while pursuant to the Kohll and Decker proce-dure, she should have been reimbursed on the basis of the rates applied in Belgium (50 thousand French Franks). The Court finally concluded that as long as the patient receives a lower level of re-imbursement than the amount that she would have received if she had been treated in her own coun-try, this would prevent her from searching for a cross-border healthcare provider, this is why the
imbursement equivalent to the difference between the reimbursement level specified in the laws of the member state of affiliation and the reimbursement level applied by the member state of treatment should be provided to the patient.
This circumstance is explained by that as long as the insured person receives less favorable reimbursement for using hospital treatment in another member state than when the same care is received in the member state of affiliation, this may make the patient uncertain about, or may even prevent them from consult-ing healthcare service providers in another member state, which in turn consti-tutes an obstacle to the freedom to provide services.490
As it turns out from the above, the directive endeavors to codify the liberal ju-dicial case law related to reimbursement, however, it also takes the requirement to safeguard the financial interests of the member states into account. The com-petence of the member state is primarily manifested in that the member states are entitled to determine which healthcare services will be reimbursed by the in-surer, however, this right can only be exercised within the framework provided by the directive.491 Thus, as a general rule, it is not mandatory to provide reim-bursement if the healthcare service is not listed in the ‘insurance package of the member state’. Such services typically include the different plastic surgeries ex-clusively done for aesthetic purposes.
However, if the healthcare service provided in another member state is not in-cluded in the ‘list of reimbursable treatments’, in each case individual conside-ration should be given to the granting or rejection of authorization by the com-petent authority of the country of affiliation if the medical condition in question cannot be treated in the member state of affiliation. Consequently, if no appro-priate treatment can be provided, such national regulation in which authorization is automatically rejected on the basis that such treatment is not available in the territory of the member state in question goes contrary to EU law.492
However, it should be underlined that if the national regulation has sufficient detail, and it only provides reimbursement for a certain type of treatment in the healthcare service used in its territory, then this principle will also be valid out-wards, i.e. it is only this very type of treatment that will be reimbursed in the case of healthcare services received in another member state too. The principle
Court instructed the Belgian authorities to reimburse the patient by applying the higher Belgian rates.
490 Case C–368/98, Vanbraekel, p. 45.
491 See: Para. (3), Art. 7 of the directive.
492 See: Art. 8 (5) of the directive: ‘The Member State of affiliation may not refuse to grant prior autho-risation when the patient is entitled to the healthcare in question in accordance with Article 7, and when this healthcare cannot be provided on its territory within a time limit which is medically justi-fiable, based on an objective medical assessment of the patient’s medical condition, the history and probable course of the patient’s illness, the degree of the patient’s pain and/or the nature of the pa -tient’s disability at the time when the request for authorisation was made or renewed.’
itself is laid down in Paragraph (5), Article 8 of the directive, the basis for which was provided by the famous Elchinov decision of the Court.493 However, the Bulgarian regulation that served as the basis for the Elchinov case was not de-tailed, so it did not accurately define what treatments were eligible to reimburse-ment (more specifically: it does make a difference whether a national law stipu-lates that it ensures ophthalmic care, or says that it ensures a specific form of ophthalmic care).
Finally, when discussing the rules of reimbursement, those provisions which contain more favorable conditions for the patients depending on the discretion of the member states than those provided by the general rule should also be men-tioned. The situation is that the member states may decide to reimburse the total costs, as long as the total costs of the cross-border healthcare services exceed the costs of the treatment in the patient’s own territory.
This also refers to the reimbursement of the so-called related costs, such as accommodation or travel costs, as well as extra costs which persons with dis-abilities might incur.494
493 Elchinov is a Bulgarian resident, who held a health insurance with NZOK (the National Health In-surance Fund of Bulgaria) and suffered from a serious condition. He asked the health inIn-surance fund to issue form No. E 112, to ensure that he can receive a peak technology treatment which is not ap -plied in Bulgaria at a Berlin-based specialist clinic. With regard to his health condition, Elchinov was in the meantime admitted to the German clinic and he received the treatment there before he got any response from NZOK. The director of NZOK, however, refused to grant the requested autho-rization to Elchinov, among others, because the conditions for granting the authoautho-rization laid down in Article 22 of the directive had not been met, as the director thought that the treatment in question was not listed among those regulated by Bulgarian law and reimbursed by NZOK. According to the Court’s decision, the authorization cannot be refused in a case where the treatments specified by the national laws are provided in a list in which the applied treatment method is not specifically or accu-rately mentioned, where only the types of treatments reimbursed by the competent institution are de-fined, and by applying the usual principles of interpretation, after conducting an objective and non-discriminative assessment, by taking all the relevant medical criteria and available scientific data into account, it is concluded that this method of treatment corresponds to the types of treatment specified in the list in question. Judgment of 5 October 2010 in Case C-173/09, Georgi Ivanov Elchinov v Natsionalna zdravnoosiguritelna kasa (Elchinov case), [2010] ECR 08889., Gabriella Berki, ‘Az Európai Bíróság újabb ítélete az egészségügyi szolgáltatás tervezett külföldi igénybevé-telének tárgyában. A tagállami ellátási csomag tartalmának kérdése’ (A new decision adopted by the European Court of Justice on the planned use of cross-border health services abroad. The contents of the member state treatment package), Jogesetek Magyarázata, 2012/2.
494 Art. 7(4) (3) of the Directive. See: Judgment of 15 June 2006 in Case C-466/04, Manuel Acerada Herrera v. Servicio Cantabro de Salud, [2006] ECR 05341. In this decision, it was declared by the Court that Article 22 of the decree cannot be interpreted as one that generates eligibility for the in-sured person authorized to travel to another member state to use hospital treatment to receive reim-bursement from the institution mentioned above, for their own costs incurred in the territory of this member state, or the travel, accommodation and meal costs incurred by the person who accompanies them, except for the hospital accommodation and meal costs of the insured person.
3.2 Prior authorization in the provisions of the directive
On the one hand, the directive maintains the compelling requirements set forth in its earlier case law, however, it also extends the scope of healthcare services that may depend on prior authorization, which are as follows: (1) the goal of en-suring sufficient and permanent access to a balanced range of high-quality healthcare services; (2) the existence of planning requirements related to the en-deavor to control costs and prevent any waste of financial, technical and human resources; (3) finally, when the maintenance of the service capacity and the healthcare expertise in the territory of the member state are of critical impor-tance for public health.
It is in view of these three compelling requirements that those cases where prior authorization may be required can be defined. This is the subject of Article 8 of the directive, which specifies three such groups of services. Prior authoriza-tion does not extend to those services which are beyond this scope, including the majority of non-hospital services.
Thus, it can be pointed out that in the directive, it is the closed list of services that require authorization that is specified, ensuring flexible interpretation for the member states. So, the question remains which those cases are where the provision of healthcare services may be tied to prior authorization according to the rules of the directive.
(1) The healthcare service is made subject to planning requirements relating to the object of ensuring sufficient and permanent access to a balanced range of high-quality treatment in the Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resource and, cumulatively, one of the options described in the two subsections below is realized (see Point (2) (a) of Article 8 of the directive).
Thus, it involves overnight hospital accommodation of the patient in question for at least one night, or requires the use of highly specialized and cost-intensive medical infrastructure or medical equipment.
As regards hospital treatment, as has been pointed out by the Court in the Smits and Peerbooms case, prior authorization is fully understandable, as the number, geographical position, level of equipment of the hospitals and the medi-cal services that they offer require thorough planning. Thus, the member states enjoy a high level of freedom regarding this policy, which allows them to apply different standards in the individual regions. However, it can be assumed that the directive will contribute to a ‘common thinking’ of the member states in the bor-der regions.
At the same time, it is also possible that the healthcare service is provided out-side the hospital but it still requires the use of highly specialized and
cost-inten-sive medical infrastructure or medical equipment, so it will also make prelimi-nary planning necessary, similarly to the above cases. The Commission v France case495 gives an important insight, since it was declared by the Court that the use of MRI scanners and PET scanners should be regarded as such.
The other two groups of cases discussed in the directive belong much more to the public health exceptions explained in Article 36 of the Treaty on the Func-tioning of the European Union than under the justification criteria for the com-pelling requirements.
(2) Thus, if the healthcare service involves treatments presenting a particular risk for the patient or the population (see Points (2) (a) and (b) of Article 8 of the directive),
(3) or the healthcare service is provided by a healthcare provider that, on a case-by-case basis, could give rise to serious and specific concerns relating to the quality or safety of the care (see Point (2) (c) of Article 8 of the directive).496
The latter exceptions were included in the text of the law at the express re-quest of the Council in order to increase the space of the member states, what is more, without an accurately defined wording.497 This may give too wide a space of maneuver to the member states, furthermore, it may generate tension on the basis of case law, since a distinction is only made between hospital and non-hos-pital care.
Finally, one of the key guarantee elements of the directive cannot be stressed enough, i.e. that the authority may only refuse to grant prior authorization on the basis of the reasons specified individually in the closed list in Paragraph (6), Article 8 of the directive.
3.3 Patients’ rights
In the preamble, it is strongly emphasized that European values should be taken into account in public health and the comprehensive values of universality, ac-cess to good quality care, equity and solidarity are specifically highlighted.498 In this respect, those endeavors of the European Union which are targeted at the so-cial commitment after the adoption of the Union’s Treaty of Lisbon (or at least this is what is meant to be demonstrated) are well reflected, on the one hand, in declaring the healthcare rights specified in the Charter of Fundamental Rights,
495 Judgment of 5 October 2010 in Case C-512/08, Commission v France, [2010] ECR 08833.
496 These derogations can actually be connected to the secondary legislation on pharmaceutical products or the practicing of healthcare professions.
497 According to the original draft, the list that was to be prepared by the Council would have contained the specific cases.
498 See the directive, Point 21 of the Preamble.
on the other hand, through the ‘social clause’ that was included in the primary law.499
This value-oriented approach is also obvious in the guarantee requirement of the directive, according to which the various administrative and financial con-siderations should not play any role in deciding whether to grant or refuse prior authorization.500 Thus, under Paragraph (5), Article 8, prior authorization cannot be refused if the healthcare service cannot be provided within a medically rea-sonable time based on an objective medical assessment regarding the patient’s condition at the time of submitting or renewing the application for authorization, the patient’s medical history and the probable progress of the disease, as well as the intensity of the pain suffered by the patient, or the disability of the patient.
Although the directive, in harmony with the judicial case law, specifically with the Watts case, does not criticize the waiting list system in itself, it requires some flexibility from the member states in this respect. At this point, the above-mentioned values are given key importance. The situation is that bureaucratic and financial considerations can never be more important than the condition of the patient. As is also laid down in the preamble to the directive, ‘(…) the re-fusal to grant prior authorisation may not be based on the ground that there are waiting lists on national territory intended to enable the supply of hospital care to be planned and managed on the basis of general clinical priorities’,501 as long as there is no objective, personalized medical examination.
Finally, when speaking of new types of patients’ rights, the information autho-rizations guaranteed by the directive should also be mentioned.
According to the provisons set out by the directive, each member state shall designate one or more national contact points for cross-border healthcare and communicate their names and contact details to the Commission.502 In order to enable patients to make actual use of their rights in relation to cross-border healthcare, national contact points in the member state of treatment shall provide them with information concerning healthcare providers, as well as information on patients’ rights, with special regard to complaints procedures and mecha-nisms for seeking remedies, furthermore, the legal and administrative options available to settle disputes, including in the event of harm arising from cross-border healthcare. Access to information and providing information are of key importance in a sensitive area like cross-border healthcare, as it is based on these that the patient can make a truly informed decision on using a healthcare service abroad.503
499 Art. 9 of the Treaty on the Functioning of the European Union.
500 Watts case, Point 120.
501 See the directive, Point 43 of the Preamble.
502 See Art. 6 of the directive in question.
It is the responsibility of the healthcare providers under the effect of the direc-tive to provide information on the specific healthcare services. Point (2) (b) of Article 4 of the directive provides on that healthcare providers provide relevant information to help individual patients to make an informed choice on treatment options, on the availability, quality and safety of the healthcare that they provide in the Member State of treatment and that they also provide clear invoices and clear information on prices, as well as on their authorisation or registration sta-tus, their insurance cover or other means of personal or collective protection with regard to professional liability. To the extent that healthcare providers al-ready provide patients resident in the Member State of treatment with relevant
It is the responsibility of the healthcare providers under the effect of the direc-tive to provide information on the specific healthcare services. Point (2) (b) of Article 4 of the directive provides on that healthcare providers provide relevant information to help individual patients to make an informed choice on treatment options, on the availability, quality and safety of the healthcare that they provide in the Member State of treatment and that they also provide clear invoices and clear information on prices, as well as on their authorisation or registration sta-tus, their insurance cover or other means of personal or collective protection with regard to professional liability. To the extent that healthcare providers al-ready provide patients resident in the Member State of treatment with relevant