1 This request for a preliminary ruling concerns the interpretation of Articles 49 and 56 TFEU, Article 22(1)(c) of Council Regulation (EEC) No 1408/71 of 14 June 1971 on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community (OJ 1971 L 149, p. 2), in the version amended and updated by Council Regulation (EC) No 118/97 of 2 December 1996 (OJ 1997 L 28, p. 1), as amended by Regulation (EC) No 592/2008 of the European Parliament and of the Council of 17 June 2008 (OJ 2008 L 177, p. 1) (‘Regulation No 1408/71’), and Article 7(7) of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ 2011 L 88, p. 45), as well as the principles of free movement of patients and services and the principles of efficiency and proportionality.
2 The request has been made in proceedings between AF, a natural person residing in Romania, on the one hand, and the Guvernul României (Romanian Government), the Ministerul Sănătăţii (Ministry of Health, Romania), and the Casa Judeţeană de Asigurări de Sănătate Mureș (District Health Insurance Fund, Mureș, Romania) (‘the Health Insurance Fund’), on the other, concerning the refusal, by those authorities, to reimburse AF for the costs of the healthcare with which he was provided in Germany.
3 Article 49 TFEU is worded as follows: ‘Within the framework of the provisions set out below, restrictions on the freedom of establishment of nationals of a Member State in the territory of another Member State shall be prohibited. Such prohibition shall also apply to restrictions on the setting-up of agencies, branches or subsidiaries by nationals of any Member State established in the territory of any Member State. Freedom of establishment shall include the right to take up and pursue activities as self-employed persons and to set up and manage undertakings, in particular companies or firms within the meaning of the second paragraph of Article 54, under the conditions laid down for its own nationals by the law of the country where such establishment is effected, subject to the provisions of the Chapter relating to capital.’
4 The first paragraph of Article 56 TFEU provides: ‘Within the framework of the provisions set out below, restrictions on freedom to provide services within the [European] Union shall be prohibited in respect of nationals of Member States who are established in a Member State other than that of the person for whom the services are intended.’
5 Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems (OJ 2004 L 166, p. 1, and corrigendum OJ 2004 L 200, p. 1) repealed and replaced Regulation No 1408/71 with effect from 1 May 2010.
6 Article 20 of Regulation No 883/2004, entitled ‘Travel with the purpose of receiving benefits in kind - authorisation to receive appropriate treatment outside the Member State of residence’, provides, in paragraphs 1 and 2 thereof: ‘1. Unless otherwise provided for by this Regulation, an insured person travelling to another Member State with the purpose of receiving benefits in kind during the stay shall seek authorisation from the competent institution. 2. An insured person who is authorised by the competent institution to go to another Member State with the purpose of receiving the treatment appropriate to his/her condition shall receive the benefits in kind provided, on behalf of the competent institution, by the institution of the place of stay, in accordance with the provisions of the legislation it applies, as though he/she were insured under the said legislation. The authorisation shall be accorded where the treatment in question is among the benefits provided for by the legislation in the Member State where the person concerned resides and where he/she cannot be given such treatment within a time limit which is medically justifiable, taking into account his/her current state of health and the probable course of his/her illness.’
7 Recitals 5 and 29 to 31 of Directive 2011/24 read as follows:
8 Under Article 1 of that directive: ‘1. This Directive provides rules for facilitating the access to safe and high-quality cross-border healthcare and promotes cooperation on healthcare between Member States, in full respect of national competencies in organising and delivering healthcare … [and] also aims at clarifying its relationship with the existing framework on the coordination of social security systems, Regulation (EC) No 883/2004, with a view to application of patients’ rights. … 4. This Directive shall not affect laws and regulations in Member States relating to the organisation and financing of healthcare in situations not related to cross-border healthcare. In particular, nothing in this Directive obliges a Member State to reimburse costs of healthcare provided by healthcare providers established on its own territory if those providers are not part of the social security system or public health system of that Member State.’
9 Article 7 of Directive 2011/24, entitled ‘General principles for reimbursement of costs’, provides: ‘1. Without prejudice to Regulation (EC) No 883/2004 and subject to the provisions of Articles 8 and 9, the Member State of affiliation shall ensure the costs incurred by an insured person who receives cross-border healthcare are reimbursed, if the healthcare in question is among the benefits to which the insured person is entitled in the Member State of affiliation. … 4. The costs of cross-border 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 exceeding the actual costs of healthcare received. … 7. The Member State of affiliation may impose on an insured person seeking reimbursement of the costs of cross-border healthcare, including healthcare received through means of telemedicine, the same conditions, criteria of eligibility and regulatory and administrative formalities … as it would impose if this healthcare were provided in its territory. This may include an assessment by a health professional or healthcare administrator providing services for the statutory social security system or national health system of the Member State of affiliation, such as the general practitioner or primary care practitioner with whom the patient is registered, if this is necessary for determining the individual patient’s entitlement to healthcare. However, no conditions, criteria of eligibility and regulatory and administrative formalities imposed according to this paragraph may be discriminatory or constitute an obstacle to the free movement of patients, services or goods, unless it is objectively justified by 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 resources. 8. The Member State of affiliation shall not make the reimbursement of costs of cross-border healthcare subject to prior authorisation except in the cases set out in Article 8. …’
10 The ‘detailed rules on cross-border healthcare’ (‘the detailed rules’) are set out in the annex to Hotărârea Guvernului nr. 304/2014 pentru aprobarea Normelor metodologice privind asistența medicală transfrontalieră (Government Decision No 304/2014 approving detailed rules on cross-border healthcare) of 16 April 2014 (Monitorul Oficial al României, Part I, No 318, of 30 April 2014).
11 Article 3(1) of the detailed rules provides: ‘At the written request of the insured person, a member of his or her family (parent, spouse, son/daughter) or a person authorised by him or her, accompanied by supporting documents, the health insurance fund shall reimburse the consideration for cross-border healthcare provided in the territory of a Member State of the [Union] and paid for by the insured person at the rates provided for in Article 4 if: … (b) the following eligibility criteria are met: (i) hospital medical services were provided in another Member State of the [Union] following a medical assessment carried out by a health professional providing health services under the Romanian social health insurance system, which gave rise to a request for hospitalisation …’
12 Article 4 of the detailed rules provides: ‘(1) The level at which reimbursement of the consideration for cross-border healthcare provided for in Article 3(1) shall be made shall be as follows: (a) for specialised outpatient medical services, medicinal products used in outpatient care, and outpatient care devices: rates expressed using the final point value, established in the quarter preceding the date on which the service was paid for, rates, percentage of rates, reference prices, rental amounts, amounts corresponding to the application of the compensation percentage with regard to reference prices, settlement prices (maximum wholesale settlement prices plus [value added tax (VAT)]), as provided for by the legislative acts in force governing the social health insurance system in force on the date that payment for the service was made by the insured person, a member of his or her family (parent, spouse, son/daughter), or a person authorised by him or her. For medicines received by insured persons in connection with cross-border healthcare and which are not included in the Lista preţurilor de referinţă pe unitate terapeutică aferente medicamentelor - denumiri comerciale (List of reference prices per therapeutic unit relating to medicinal products - trade names), but in respect of whose international non-proprietary name provision has been made for settlement to be made from the Fondul naţional unic de asigurări sociale de sănătate (Single National Social Health Insurance Fund), the reimbursement shall be made as follows: … (iii) up to the level of the settlement price (maximum wholesale settlement price plus VAT) corresponding to a medicinal product (trade name) with the same concentration and in a similar pharmaceutical form; … (2) In a situation where the purchase of medical services, medicinal products, [or] medical devices was completed in several instalments, the level of reimbursement shall be determined by taking the date of the final instalment as the date on which payment was made. (3) No other costs - such as consideration for accommodation or travel services incurred by insured persons and additional costs incurred by persons with disabilities as a result of one or more disabilities when they receive cross-border healthcare - shall be covered.’
13 On 8 March 2018, AF, a resident of Romania affiliated with the national public health insurance system, was diagnosed with adenocarcinoma of the prostate at a private medical establishment in that Member State.
14 In view of the benefits for the patient’s health and subsequent recovery, the recommended treatment consisted of a radical prostatectomy, which could be carried out, inter alia, with the assistance of a surgical robot. AF was informed that there was such a robot at the public hospital in Cluj (Romania), but that the robot was not yet operational at that time, and that he could undergo the same procedure at the private clinic in Brașov (Romania), at a cost of approximately EUR 13 000.
15 In that context, AF decided to receive the operation using the surgical robot, at an equivalent cost, at a specialist clinic located in Germany and devoted exclusively to that pathology.
16 At the beginning of April 2018, AF requested that the Health Insurance Fund issue him with a specific form - Form E 112 - which was required under Regulation No 1408/71 in order to obtain authorisation to travel to the territory of another Member State to receive healthcare there. The Health Insurance Fund allegedly refused to register that request.
17 In parallel with that procedure, AF was offered the opportunity to be operated on in Germany on 9 May 2018, following a cancellation by another patient. Given that, if he did not take advantage of that cancellation, he would have to wait eight weeks after receiving the Health Insurance Fund’s approval before being able to request another date for surgery, AF made a payment on 24 April 2018 in order to reserve the date of 9 May 2018.
18 After making that payment, AF repeated his request for the Health Insurance Fund to issue him with Form E 112. The Health Insurance Fund refused that request on the ground that it had not been made using the standard request form and was not accompanied by the documents required by national legislation.
19 Following the operation, which did indeed take place on 9 May 2018, AF requested reimbursement from the Health Insurance Fund of the amount of EUR 13 069, corresponding to the cost of the healthcare he had received in Germany. That body refused to reimburse him for that amount on the grounds that (i) Form E 112 should have been issued before the recipient travelled to another Member State to receive healthcare there and (ii) AF should have followed the procedure provided for by the detailed rules in order to receive reimbursement.
20 In particular, according to the Health Insurance Fund, AF could not claim that reimbursement, because he had not attached to his request a copy of the ‘request for hospitalisation’ drawn up by a health professional providing health services under the Romanian social health insurance system, as expressly required by Article 3(1)(b)(i) of the detailed rules.
21 AF brought an action before the Curtea de Apel Târgu Mureș (Court of Appeal, Târgu Mureș, Romania) seeking (i) the annulment, in part, of Government Decision No 304/2014 approving detailed rules on cross-border healthcare, (ii) the annulment of various refusal letters issued by the Health Insurance Fund, and (iii) the reimbursement of all the costs associated with the medical treatment he had received in Germany. He claimed, inter alia, that the provisions of Romanian law concerning the conditions for reimbursement of the costs of medical services and the method for calculating reimbursement of the costs of cross-border healthcare constituted an incorrect transposing of Directive 2011/24. AF added that he was entitled to reimbursement of the full cost of the treatment carried out in Germany, or at least reimbursement up to the level of the costs for which he would have been reimbursed in Romania on the basis of the national health insurance system if he had been issued with the authorisation to undergo the surgical operation in question beforehand.
22 By a ruling of 30 December 2019, the Curtea de Apel Târgu Mureș (Court of Appeal, Târgu Mureș) dismissed AF’s action as unfounded.
23 AF then brought an appeal against that ruling before the Înalta Curte de Casație și Justiție (High Court of Cassation and Justice, Romania), which is the referring court.
24 That court has doubts as to the compatibility with EU law of the provisions of Romanian law which make the reimbursement of the costs of cross-border medical services subject to (i) a medical assessment being carried out by a health professional belonging to the public health system of the Member State of affiliation - to the exclusion of a health professional belonging to the private health system of that State - and (ii) a document authorising the hospitalisation of the insured person subsequently being issued by such a health professional.
25 In addition, it questions whether the national rule which limits the amount of reimbursement of the costs of cross-border medical services significantly as compared with the costs actually incurred by that insured person in the Member State where those medical services were provided is consistent with EU law. Under that national rule, AF, who had incurred, according to the documents in the file submitted to the Court, a cost of EUR 13 069, could be reimbursed only for an amount of between 1 367 and 4 618 Romanian lei (RON) (approximately EUR 280 to 925).
26 In those circumstances, the Înalta Curte de Casație și Justiție (High Court of Cassation and Justice) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:
27 In response to a request for information made by the Court of Justice, the referring court has indicated, in essence, first of all, that the medical operation performed on the appellant in the main proceedings is included, as required by Article 7(1) of Directive 2011/24, among the services the costs of which are to be assumed by the competent Romanian authority in so far as, while the treatment method or medical technique are, admittedly, not specified as such in national legislation, that service is nevertheless part of a list of diagnostic groups established by decree. Next, that court has specified that the medical operation at issue in the main proceedings is among the services subject to ‘the [prior] issuing of Form E 112’. Lastly, it has explained that the condition relating to a prior assessment being carried out by a professional falling exclusively within the public health system applies both to the provision of national healthcare and to the provision of cross-border healthcare.
28 As a preliminary point, it should be noted that, according to the statements made by the referring court, the ‘request for hospitalisation’ concerned by the first question is a document intended to bear witness to the fact that a medical assessment of the insured person has been carried out by a health professional belonging to the Romanian public health insurance system, authorising the hospitalisation of that person. The interpretation provided by the Court will therefore be based on that factual premiss, the accuracy of which it is however for the referring court to verify.
29 In addition, it should be noted that it is not apparent from any of the documents in the file submitted to the Court that there is a link between the situation at issue in the main proceedings and the exercise of the freedom of establishment as enshrined in Article 49 TFEU. Accordingly, there is no need to interpret that provision in the present case.
30 In those circumstances, it must be held that, by its first question, the referring court asks, in essence, whether Article 7(7) of Directive 2011/24, read in the light of Article 56 TFEU, is to be interpreted as precluding national legislation which makes reimbursement of the costs of cross-border healthcare incurred by an insured person in the Member State of affiliation subject to a medical assessment, carried out by a health professional belonging to the public health insurance system of that State, which has given rise to the issuing, by that health professional, of a document authorising the hospitalisation of that insured person.
31 In that regard, it should be borne in mind that, according to settled case-law, in interpreting a provision of EU law it is necessary to consider not only its wording, but also its context and the objectives pursued by the rules of which it is part (judgments of 17 November 1983, Merck, 292/82, EU:C:1983:335, paragraph 12, and of 30 April 2025, Generalstaatsanwaltschaft Frankfurt am Main (Export of cash to Russia), C‑246/24, EU:C:2025:295, paragraph 18 and the case-law cited).
32 In the first place, as regards the wording of Article 7(7) of Directive 2011/24, it is apparent therefrom that a Member State of affiliation may, subject to the limits set out in that provision, impose on an insured person seeking reimbursement of the costs of cross-border healthcare the same conditions, criteria of eligibility and regulatory and administrative formalities as it would impose if this healthcare were provided in its territory. That provision specifies that this may include an assessment by a health professional or healthcare administrator providing services for the statutory social security system or national health system of the Member State of affiliation, such as the general practitioner or primary care practitioner with whom the patient is registered, if this is necessary for determining the individual patient’s entitlement to healthcare.
33 It thus follows from the wording of that provision that a Member State may, in principle, require that the person insured in the Member State of affiliation be subject to a medical assessment by a health professional belonging to the ‘statutory social security system’ or the ‘national health system of [that] State’.
34 However, it is necessary to determine whether that wording is suggesting that the EU legislature intended to enable the Member States to make reimbursement to the insured person, in his or her Member State of affiliation, of the costs of cross-border healthcare incurred by him or her subject to a medical assessment, carried out exclusively by a health professional belonging to the statutory public social security system or the national health system of that Member State, which has given rise to the issuing, by that health professional, of a document authorising the hospitalisation of that insured person.
35 In that regard, in the second place, it should be borne in mind, as regards the context in which Article 7(7) of Directive 2011/24 occurs, that Article 1(4) thereof provides, inter alia, that none of the provisions of that directive obliges a Member State to reimburse costs of healthcare provided by healthcare providers established on its own territory if those providers are not part of the social security system or public health system of that Member State.
36 In so far as Article 7(7) of Directive 2011/24 provides that the Member State of affiliation may impose on a person seeking reimbursement of the costs of cross-border healthcare the same conditions, criteria of eligibility and regulatory and administrative formalities as it would impose if this healthcare were provided in its territory, it follows from this that, where a Member State has chosen not to reimburse costs of healthcare provided by healthcare providers established on its own territory unless those providers are part of the social security system or public health system of that Member State, the same condition may, in principle, be imposed in connection with that provision.
37 As has been noted, in essence, by the Advocate General in points 56 and 57 of his Opinion, Directive 2011/24 does not harmonise the healthcare or health insurance systems of the Member States and does not require a national health system to be organised in a certain way.
38 Accordingly, it follows from a literal and contextual interpretation of Article 7(7) of Directive 2011/24 that that provision does not preclude - subject to the limits expressly laid down by that provision which it will be necessary to examine subsequently - a Member State of affiliation from requiring, for the purposes of the reimbursement of the costs of cross-border healthcare, that that reimbursement be subject to a medical assessment of the insured person, carried out by a health professional belonging to the public health system or health insurance system of that Member State, which has given rise to the issuing, by that health professional, of a document authorising the hospitalisation of that insured person.
39 That interpretation is borne out, in the third place, by the purpose pursued by Directive 2011/24.
40 It should be borne in mind that Directive 2011/24 is intended, as is apparent from Article 1(1) thereof, to facilitate access to safe and high-quality cross-border healthcare and promotes cooperation on healthcare between Member States, in full respect of national competencies in organising and delivering healthcare.
41 In that regard, recital 5 of that directive specifies that decisions about, inter alia, the mechanisms used to finance and deliver cross-border healthcare must be taken in the national context.
42 It follows that the Member States have a broad discretion to determine the arrangements and conditions for reimbursing the costs of cross-border healthcare services, so that they may provide that such services are to be subject to certain conditions, such as the condition that the insured person has undergone, in the Member State of affiliation, a medical assessment, carried out by a health professional belonging exclusively to the public health system or health insurance system of that Member State, which has given rise to the issuing, by that health professional, of a document authorising the hospitalisation of that insured person.
43 However, as has been stated in paragraph 38 of the present judgment, it is still necessary to verify whether that national condition complies with the limits set out in paragraph 7 of Article 7 of Directive 2011/24. In that regard, it should be borne in mind that that provision states, in the last sentence thereof, that the conditions, criteria of eligibility and regulatory and administrative formalities imposed according to that paragraph may not be discriminatory or constitute an obstacle to, inter alia, the freedom to provide services guaranteed by Article 56 TFEU, unless that obstacle is objectively justified by 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 resources.
44 In this instance, as regards, in the first place, the existence of possible discrimination or obstacles contrary to Article 56 TFEU, it is apparent from the referring court’s answer to the request for information put to it by the Court of Justice that the condition, laid down by Article 3(1)(b)(i) of the detailed rules, that the reimbursement of the costs of cross-border healthcare is subject to a medical assessment, carried out by a health professional belonging to the Romanian public health insurance system, which has given rise to the issuing, by that health professional, of a document authorising the hospitalisation of that insured person is also laid down in a similar way in respect of healthcare provided in Romania. As that condition thus applies identically to cross-border and national healthcare, it is not discriminatory.
45 However, the Court has repeatedly held that Article 56 TFEU precludes the application of any national rules which have the effect of making the provision of services between Member States more difficult than the provision of services purely within a Member State and that restrictions on the freedom to provide services are national measures which prohibit, impede or render less attractive the exercise of that freedom (see, to that effect, judgment of 26 September 2024, Nord Vest Pro Sani Pro, C‑387/22, EU:C:2024:786, paragraphs 39 and 40 and the case-law cited).
46 In particular, a national rule constitutes an obstacle to the freedom to provide services where, although not directly preventing persons affiliated with the public health insurance system from approaching providers of medical services established in other Member States, it has a deterrent effect on the use of cross-border healthcare services (see, to that effect, judgment of 6 October 2021, Casa Naţională de Asigurări de Sănătate and Casa de Asigurări de Sănătate Constanţa, C‑538/19, EU:C:2021:809, paragraph 48 and the case-law cited).
47 By requiring a person affiliated with the Romanian social security scheme, with a view to the reimbursement of the costs of healthcare provided in another Member State, to undergo a medical assessment by a health professional belonging to the Romanian public health insurance system and to obtain from that health professional, following that assessment, a document authorising his or her hospitalisation, even though, in the context of cross-border hospital treatment, more often than not, such an assessment will be carried out and such a document will normally be drawn up by a health professional operating in the Member State in whose territory the healthcare is to be provided, the Romanian legislation lays down a condition which is capable of having a deterrent effect on the use of cross-border healthcare services.
48 Accordingly, the national legislation at issue in the main proceedings constitutes an obstacle to the freedom to provide services guaranteed by Article 56 TFEU.
49 Therefore, it is necessary, in the second place, as can be seen from paragraph 43 of the present judgment, to verify whether that obstacle may be objectively justified by planning requirements, as referred to in Article 7(7) of Directive 2011/24, 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 resources.
50 In that regard, it should also be noted that it follows from settled case-law that, even assuming that that obstacle is justified in the light of such requirements, it cannot be allowed unless (i) it is appropriate for ensuring the requirement relied on is met and (ii) it does not go beyond what is necessary to meet that requirement (see, to that effect, judgment of 21 June 2016, New Valmar, C‑15/15, EU:C:2016:464, paragraph 48 and the case-law cited).
51 In this instance, it is apparent from the order for reference that the objective pursued by the Romanian legislation consists of ensuring the financial stability of the national social security system, the Health Insurance Fund having also relied, before the referring court, on the need to control costs and avoid wasting financial resources.
52 It should be borne in mind, in that regard, that, under Article 7(4) of Directive 2011/24, the system of reimbursement of the costs of cross-border healthcare provided for in that article may be subject to a twofold limit. First, that reimbursement is to be calculated on the basis of the rates applicable to healthcare in the Member State of affiliation. Second, if the level of costs of the healthcare provided in the host Member State is lower than that of the healthcare provided in the Member State of affiliation, the reimbursement is not to exceed the actual costs of the healthcare received. Accordingly, the health system of the Member State of affiliation is not liable to be faced with a risk of additional costs linked to the assumption of the costs of cross-border healthcare in connection with Directive 2011/24, as is confirmed by recital 29 of that directive, which expressly states that that assumption of costs cannot have any significant effect on the financing of the national healthcare systems (see, to that effect, judgment of 29 October 2020, Veselības ministrija, C‑243/19, EU:C:2020:872, paragraphs 73 to 76).
53 Consequently, the general objective of preserving the financial stability of the social security system is not, in any event, capable of justifying, pursuant to Article 7(7) of Directive 2011/24, the condition requiring the insured person to have undergone a medical assessment, by a health professional belonging to the public health system or health insurance system of the Member State of affiliation, which has given rise to the issuing, by that health professional, of a document authorising the hospitalisation of that insured person.
54 Furthermore, even if it cannot be ruled out that that condition enables (i) costs to be controlled and (ii) any waste of financial resources resulting from, inter alia, needless hospitalisations prescribed by health professionals who, not belonging to the public health system or health insurance system of the Member State of affiliation, would not be constrained by a need to control public spending to be avoided as far as possible, it must be pointed out, in any event, that such a condition does not appear to be in line with the principle of proportionality referred to in paragraph 50 of the present judgment. Indeed, as the European Commission has emphasised in its written observations, less restrictive measures could have been provided for by the Romanian legislature, such as the implementation of a procedure for accepting equivalent medical certificates or reports, accompanied by review of the apparent accuracy of the diagnosis and the relevance of the proposed treatment.
55 Accordingly, the national legislation at issue in the main proceedings, inasmuch as it requires the insured person, for the purposes of the reimbursement of the costs of cross-border healthcare, to have undergone a medical assessment, carried out by a health professional belonging to the public health insurance system of the Member State of affiliation, which has given rise to the issuing, by that health professional, of a document authorising the hospitalisation of that insured person, constitutes an obstacle to the freedom to provide services which cannot be justified on the basis of Article 7(7) of Directive 2011/24, read in the light of Article 56 TFEU.
56 In the light of all those considerations, the answer to the first question is that Article 7(7) of Directive 2011/24, read in the light of Article 56 TFEU, must be interpreted as precluding national legislation which makes reimbursement of the costs of cross-border healthcare incurred by an insured person in the Member State of affiliation subject to a medical assessment, carried out by a health professional belonging to the public health insurance system of that State, which has given rise to the issuing, by that health professional, of a document authorising the hospitalisation of that insured person.
57 In the first place, it should be borne in mind that, according to settled case-law, in the context of the cooperation between the Court of Justice and the national courts provided for in Article 267 TFEU, it is solely for the national court, before which the dispute has been brought and which must assume responsibility for the subsequent judicial decision, to determine, in the light of the particular circumstances of the case, both the need for a preliminary ruling in order to enable it to deliver judgment and the relevance of the questions which it submits to the Court. Consequently, where the questions submitted concern the interpretation of EU law, the Court is, in principle, bound to give a ruling (judgments of 29 November 1978, Redmond, 83/78, EU:C:1978:214, paragraph 25, and of 20 March 2025, Arce, C‑365/23, EU:C:2025:192, paragraph 38 and the case-law cited).
58 It follows that questions concerning EU law enjoy a presumption of relevance. The Court may refuse to rule on a question submitted by a national court only where it is quite obvious that the interpretation of EU law that is sought bears no relation to the actual facts of the main action or its purpose, where the problem is hypothetical, or where the Court does not have before it the factual or legal material necessary to give a useful answer to the questions submitted to it (judgment of 20 March 2025, Arce, C‑365/23, EU:C:2025:192, paragraph 38 and the case-law cited).
59 In this instance, the second question concerns, inter alia, the interpretation of Regulation No 1408/71, which was repealed and replaced by Regulation No 883/2004, while the first question concerned, for its part, the interpretation of Directive 2011/24.
60 As regards the link between Directive 2011/24, on the one hand, and Regulation No 883/2004, on the other, it should be emphasised that recital 30 of that directive states that, for the sake of consistency, either the directive is to apply or the Union regulations on the coordination of social security systems, which include Regulation No 883/2004, are to apply. In addition, recital 31 of Directive 2011/24 specifies, in that regard, that, where the patient is entitled to cross-border healthcare under both that directive and Regulation No 883/2004, and the application of that regulation is more advantageous to the patient, the patient’s attention should be drawn to this by the Member State of affiliation.
61 Accordingly, the question of the applicability, to a factual situation, of Regulation No 883/2004 or of Directive 2011/24 depends on the choice of the insured person and the duty of the Member State of affiliation to advise the patient regarding that choice. As this is an assessment of a factual nature, it is not for the Court to give a ruling as to the applicability of one or other of those acts of the Union to the dispute in the main proceedings.
62 Consequently, in light of the presumption of relevance enjoyed by the second question, as derived from the case-law referred to in paragraph 58 of the present judgment, it is for the Court to examine that question in the light of Regulation No 883/2004 in order to provide the referring court with an answer which will be of use to it, it being nonetheless specified that it will be for the referring court to verify, having regard to the clarifications provided in paragraphs 60 and 61 of the present judgment, whether that regulation is applicable to the situation of the appellant in the main proceedings, as the application of that regulation cannot be combined with the application of Directive 2011/24 in respect of the same instance of healthcare provision.
63 In the second place, it should be borne in mind that, according to settled case-law, in the procedure laid down by Article 267 TFEU providing for cooperation between national courts and the Court of Justice, it is for the latter to provide the national court with an answer which will be of use to it and enable it to decide the case before it. To that end, the Court should, where necessary, reformulate the questions submitted to it. The Court may also find it necessary to consider provisions of EU law which the national court has not referred to in its questions (judgments of 17 July 1997, Krüger, C‑334/95, EU:C:1997:378, paragraphs 22 and 23, and of 15 July 2021, Ministrstvo za obrambo, C‑742/19, EU:C:2021:597, paragraph 31 and the case-law cited).
64 In this instance, it must be pointed out, first, that it is not Regulation No 1408/71, but Regulation No 883/2004 that is applicable rationae temporis to the dispute in the main proceedings. Second, as has been noted in paragraph 29 of the present judgment, the request for a preliminary ruling does not contain any element permitting the consideration that the situation at issue in the main proceedings falls within the scope of Article 49 TFEU.
65 In those circumstances, it is appropriate to reformulate the second question and to consider that, by that question, the referring court asks, in essence, whether Article 20(1) and (2) of Regulation No 883/2004, read in the light of Article 56 TFEU, is to be interpreted as precluding national legislation pursuant to which, where an insured person has not obtained the prior authorisation required in order to receive certain cross-border healthcare, the amount of reimbursement of the costs of that healthcare by the Member State of affiliation is limited to the amount provided for by the health insurance scheme of that State, applying, to that end, a calculation method which significantly limits the amount of that reimbursement as compared with the costs actually incurred by the insured person in the Member State where he or she was provided with that healthcare.
66 In that regard, it should be borne in mind that, under Article 20(1) of Regulation No 883/2004, unless otherwise provided for by that regulation, an insured person travelling to a Member State other than his or her Member State of residence with the purpose of receiving benefits in kind during his or her stay must seek authorisation from the competent institution.
67 In accordance with the second sentence of Article 20(2) of that regulation, such authorisation must be given by the competent institution where the two conditions laid down in that sentence are satisfied (judgment of 6 October 2021, Casa Naţională de Asigurări de Sănătate and Casa de Asigurări de Sănătate Constanţa, C‑538/19, EU:C:2021:809, paragraph 30 and the case-law cited).
68 Under the first sentence of Article 20(2) of that regulation, an insured person who has obtained that authorisation is to receive the benefits in kind provided, on behalf of the competent institution, by the institution of the place of stay, in accordance with the provisions of the legislation it applies, as though he or she were insured under that legislation.
69 That being said, as the applicability of Article 20 of Regulation No 883/2004 to a given situation does not mean that provisions on the freedom to provide services and, in this instance, Article 56 TFEU, cannot apply to that situation at the same time, that article of that regulation must be interpreted in the light of that provision of the FEU Treaty and of the case-law of the Court relating thereto (judgment of 6 October 2021, Casa Naţională de Asigurări de Sănătate and Casa de Asigurări de Sănătate Constanţa, C‑538/19, EU:C:2021:809, paragraph 32 and the case-law cited).
70 The Court has identified two scenarios in which an insured person, even without an authorisation issued before the beginning of the provision of scheduled treatment in the Member State of stay, is entitled to obtain reimbursement directly from the competent institution in an amount equivalent to that which would ordinarily have been assumed by that institution if he or she had had such an authorisation.
71 In the first scenario, the insured person is entitled to obtain such reimbursement when, an application for authorisation having been made by that insured person, that application has been refused by the competent institution and it is subsequently established, either by the competent institution itself or by a court decision, that that refusal was unjustified (judgment of 6 October 2021, Casa Naţională de Asigurări de Sănătate and Casa de Asigurări de Sănătate Constanţa, C‑538/19, EU:C:2021:809, paragraph 38 and the case-law cited).
72 In the second scenario, the insured person is entitled to obtain such reimbursement when, for reasons relating to his or her state of health or to the need to receive urgent treatment in a hospital, that person was prevented from applying for such authorisation or was not able to wait for the decision of the competent institution on the application for authorisation submitted. The Court has held in that respect that national legislation which excludes, in all cases, reimbursement in respect of hospital treatment given in another Member State without prior authorisation deprives the insured person of reimbursement in respect of such treatment, even though all other conditions for reimbursement are satisfied. Such legislation, which cannot be justified by requirements of public interest and, in any event, does not meet the requirement of proportionality, therefore constitutes an unjustified restriction on the freedom to provide services (judgment of 6 October 2021, Casa Naţională de Asigurări de Sănătate and Casa de Asigurări de Sănătate Constanţa, C‑538/19, EU:C:2021:809, paragraph 39 and the case-law cited).
73 On the other hand, insured persons who travel to a Member State other than the Member State of affiliation with the purpose of receiving hospital treatment there who have not sought and obtained the prior authorisation required or in respect of whom the refusal to issue a prior authorisation is well founded may claim reimbursement in respect of that treatment, on the basis of Article 56 TFEU, only within the limits of the cover provided by the health insurance scheme of the Member State of affiliation (see, to that effect, judgments of 5 October 2010, Elchinov, C‑173/09, EU:C:2010:581, paragraph 80 and the case-law cited, and of 23 September 2020, Vas Megyei Kormányhivatal (Cross-border healthcare), C‑777/18, EU:C:2020:745, paragraph 63).
74 The Court has also specified, in that regard, that nothing precludes a Member State from fixing the amounts of the reimbursement which patients who have received care in another Member State can claim, provided that those amounts are based on objective, non-discriminatory and transparent criteria (judgment of 23 September 2020, Vas Megyei Kormányhivatal (Cross-border healthcare), C‑777/18, EU:C:2020:745, paragraph 64 and the case-law cited).
75 It follows from the foregoing that, where an insured person has received cross-border healthcare without having sought and obtained the prior authorisation required for that purpose or where the refusal to issue that authorisation was well founded, the insured person is entitled to reimbursement of the costs of that healthcare only within the limits of the cover provided by the health insurance scheme with which he or she is affiliated, and the amount of reimbursement of those costs may be fixed by that Member State at a level lower than that of the costs actually incurred by that insured person, provided that the mechanism for calculating that amount is based on objective, non-discriminatory and transparent criteria. In this instance, it is for the referring court to verify whether the calculation method established by the detailed rules meets those requirements. Nevertheless, if, for reasons relating to his or her state of health or to the need to receive urgent treatment in a hospital, that person was prevented from applying for such a prior authorisation or was not able to wait for the decision of the competent institution on the application for authorisation submitted, he or she is entitled to obtain reimbursement, from the competent institution, of an amount equivalent to that which would ordinarily have been assumed by that institution if he or she had had such an authorisation.
76 In the light of the foregoing considerations, the answer to the second question is that Article 20(1) and (2) of Regulation No 883/2004, read in the light of Article 56 TFEU, must be interpreted as not precluding national legislation pursuant to which, where an insured person has, justifiably, been refused the prior authorisation required in order to receive certain cross-border healthcare, the amount of reimbursement of the costs of that healthcare by the Member State of affiliation is limited to the amount provided for by the health insurance scheme of that State, applying, to that end, a calculation method which significantly limits the amount of that reimbursement as compared with the costs actually incurred by the insured person in the Member State where he or she was provided with that healthcare, provided that that calculation method is based on objective, non-discriminatory and transparent criteria. Nevertheless, if, for reasons relating to his or her state of health or to the need to receive urgent treatment in a hospital, that person was prevented from applying for such a prior authorisation or was not able to wait for the decision of the competent institution on the application for authorisation submitted, he or she is entitled to obtain reimbursement, from the competent institution, of an amount equivalent to that which would ordinarily have been assumed by that institution if he or she had had such an authorisation.
77 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable. 1. Article 7(7) of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare, read in the light of Article 56 TFEU, 2. Article 20(1) and (2) of Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems, read in the light of Article 56 TFEU,