Within the Medical Law practice of the civil law firm Costaș, Negru & Asociații, we are discussing today the judgment of the Court of Justice of the European Union of 4 September 2005 in case C-489/23, AF. In our opinion, for the reasons set out below, this judgment reconfirms a right of patients in Romania who have benefited from medical treatments that they have paid for in other Member States of the European Union to obtain reimbursement of these. Thus, based on the judgment in the AF case and Directive 2011/24/EU, Romanian citizens in similar situations will be able to successfully challenge a refusal of full or partial reimbursement by the Romanian authorities.
The Court of Justice ruled on the violation of Art. 56 TFEU on the freedom to provide medical services within the EU by the legal provisions contained in Romanian national legislation on the reimbursement of costs incurred with cross-border medical care, subject to restrictive criteria.
As a preliminary point, it should be noted that the Court has repeatedly held that Article 56 TFEU precludes the application of any national legislation which has the effect of making the provision of services between Member States more difficult than the provision of services carried out exclusively within a Member State and that national measures which prohibit, hinder or make the exercise of that freedom less attractive constitute restrictions on the freedom to provide services.
According to the Court’s settled case-law, medical services provided for remuneration fall within the scope of the provisions on the freedom to provide services, including where the care is provided in a hospital. The freedom to provide services includes the freedom of recipients of services, including persons who need to receive medical care, to move to another Member State in order to receive those services.
It follows from the case-law of the Court that Union law does not affect the competence of the Member States to organise their social security systems. It is for the legislation of each Member State to determine, on the one hand, the conditions of the right or obligation to be affiliated to a social security system and, on the other hand, the conditions giving rise to benefits. However, in exercising that competence, the Member States must comply with Union law, in particular the provisions relating to the freedom to provide services, which in the present judgment was infringed by the Romanian State.
The context of the preliminary questions referred by the High Court of Cassation and Justice to the European Court is a dispute in which the applicant, a person insured in Romania and who underwent a medical intervention (operation) in Germany (robotic prostatectomy) in 2018 and for which he incurred costs of EUR 13,069. The Romanian insurance Health Insurance Authority refused to reimburse the costs incurred, citing domestic regulations, namely Government Decision No. 304/2014, which made reimbursement subject to 2 conditional elements:
(i) obtaining prior authorization (form E112) or, as the case may be, submitting an “admission ticket” issued by a doctor from the Romanian public system;
(ii) applying a national calculation formula that significantly capped the amount of reimbursement in the absence of the aforementioned authorization.
The national court referred two preliminary questions to the CJEU regarding the compatibility of these national provisions with EU law (Directive 2011/24, Regulation 883/2004 and the principle of the freedom to provide services/Article 56 TFEU).
The first question that the Court was called upon to answer is: Does Article 7(7) of Directive 2011/24 (read in the light of Article 56 TFEU) preclude national legislation which makes the reimbursement of cross-border healthcare conditional on an assessment by a doctor from the national public system and the issuance of a hospitalisation document issued exclusively by that doctor (i.e. excluding equivalent documents issued by doctors from the private sector or from abroad)?
The first question therefore concerns the double condition relating to the assessment by a doctor from the Romanian public health insurance system, completed by the issuance of a hospitalisation note.
The Court’s reasoning took into account Directive 2011/24, which aims to facilitate access to cross-border healthcare, but which respects the competences of the Member States regarding the organisation and financing of their national health systems. Art. 7 par. (7) authorizes Member States to impose the same administrative conditions as for domestic treatments, including assessments by doctors from the national system, but these conditions may not be discriminatory or constitute unjustified obstacles to the free provision of services.
Article 7 of that Directive, entitled ‘General principles for the reimbursement of costs’, states:
‘(1) Without prejudice to Regulation (EC) No 883/2004 and subject to Articles 8 and 9, the Member State of affiliation shall ensure the reimbursement of costs incurred by an insured person receiving cross-border healthcare, if that healthcare 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 the costs which would have been borne by the Member State of affiliation if the healthcare had been provided in its territory, without exceeding the actual costs of the healthcare received.
(7) The Member State of affiliation may impose on an insured person who claims reimbursement of the costs of cross-border healthcare, including healthcare received by means of telemedicine, the same conditions, eligibility criteria and regulatory and administrative formalities […] as it would impose if the healthcare in question were provided within its territory. This may include an assessment by a healthcare professional or a healthcare administrator providing services to the statutory social security system or the national healthcare system of the Member State of affiliation, such as the general practitioner or primary care doctor with whom the patient is registered, if this is necessary to determine the patient’s individual entitlement to healthcare. However, the conditions, eligibility criteria and regulatory and administrative formalities imposed pursuant to this paragraph may not be discriminatory or constitute an obstacle to the free movement of patients, services or goods, unless this is objectively justified by planning requirements relating to ensuring sufficient and permanent access to a balanced range of high-quality treatments in the Member State concerned or by the desire to control costs and to avoid, as far as possible, any waste of financial, technical and human resources.
(8) The Member State of affiliation shall not subject the reimbursement of the costs of cross-border healthcare to prior authorisation, except in the cases provided for in Article 8.
In contrast, GD no. 304/2014 exclusively requires that the assessment and the document be issued only by a doctor from the national public system. This conditionality has, in practice, a deterrent effect on the recourse to cross-border care (since in many cases the equivalent document is issued by doctors/institutions from the State in which the treatment is provided, and cannot be obtained “in advance” from a Romanian public doctor).
Thus, the Court held that this regulation in Romanian law is an obstacle that does not pass the proportionality test: there were reasonable less restrictive measures (for example, the acceptance of equivalent medical certificates/reports and a subsequent control of the accuracy of the diagnosis and treatment) and therefore, the exclusive requirement cannot be justified.
Thus, to the first question asked, the Court answered in the affirmative, to the detriment of the national legislation, namely that Article 7(7) of Directive 2011/24, read in the light of Article 56 TFEU, precludes national legislation which makes the reimbursement of the costs of cross-border healthcare conditional on an assessment carried out exclusively by a doctor from the public health insurance system and on the issuance, by that doctor alone, of a document authorising hospitalisation.
Therefore, such a conditionality is not compatible with the right to freedom to provide healthcare services within the EU, since it constitutes an obstacle to the free movement of patients and services.
The second question to which the Court was called upon to answer is whether Article 20 (1)-(2) of Regulation 883/2004 (read in the light of Article 56 TFEU) precludes national legislation which, in the absence of prior authorisation, limits the amount of reimbursement by means of a calculation formula which substantially reduces the amount reimbursable compared to the actual cost incurred.
According to the Court, in the absence of prior authorisation, EU regulation (883/2004) allows the Member State of affiliation to limit reimbursement to the coverage provided by the national system, and the State may establish mechanisms for calculating the amount, but these must be objective, non-discriminatory and transparent; exceptions apply where the refusal of authorisation is unfounded or where patients have been unable to request authorisation for urgent medical reasons.
Regulation (EC) No 883/2004 of the European Parliament and of the Council of 29 April 2004 on the coordination of social security systems provides in Article 20 entitled “Travelling for the purpose of receiving benefits in kind. Authorisation to receive appropriate treatment outside the Member State of residence”:
“(1) Unless otherwise provided for in this Regulation, an insured person travelling to another Member State in order to receive benefits in kind during his stay must request authorisation from the competent institution.
(2) An insured person who is authorised by the competent institution to travel to another Member State in order to receive treatment appropriate to his condition shall receive benefits in kind provided, on behalf of the competent authority, by the institution of the place of stay, in accordance with the provisions of the legislation it applies, as if he were insured under that legislation. Authorisation shall be granted if the treatment in question is among the benefits provided for by the legislation of the Member State in whose territory the person concerned resides and if such treatment cannot be provided to him in the State of residence within a period justified on medical grounds, having regard to his current state of health and the probable course of his illness.’
The Court therefore ruled that Article 20(1) and (2) of Regulation 883/2004, read in the light of Article 56 TFEU, do not preclude national legislation which, where prior authorisation has been refused on a justified basis, limits reimbursement to the level of cover provided by the national system (by applying a calculation formula which even results in a significant limitation), provided that the formula is based on objective, non-discriminatory and transparent criteria. However, where the refusal of authorisation is unfounded or where the insured person was unable to request authorisation for reasons related to his state of health/urgency, the insured person is entitled to reimbursement equivalent to the amount that would have been paid if authorisation had existed.
As a result of this ruling of the Court of Justice of the European Union, the Romanian authorities are required to amend their methodological rules or administrative practice in such a way as to:
– accept “equivalent” medical documents issued by private providers or providers in the host Member State, under conditions in which the justification of the diagnosis and treatment can be subsequently verified; or
– establish less restrictive administrative procedures that do not create unjustified obstacles to access to cross-border treatments (e.g. recognition of foreign medical reports, documentary verification procedures, possibilities to request a rapid national assessment in specific cases).
On the other hand, as regards the capping of the reimbursement amount when prior authorisation is lacking, the exceptional situation in which authorisation is not mandatory (urgent cases) is not applicable: the rules may provide for calculation formulas that reduce the reimbursable amount compared to the actual cost, but the formula must be objective, non-discriminatory and transparent.
This article was prepared for the blog of the law firm Costaș, Negru & Asociații by atty. Clara Dohotar, from the Bucharest Bar Association.
Costaș, Negru & Asociații is a law firm with offices in Cluj-Napoca, Bucharest and Arad, which provides assistance, legal representation and advice in several practice areas through a team of 16 lawyers and consultants. Details of the legal services and the composition of the team can be found at https://www.costas-negru.ro. All rights for materials published on the company’s website and via social media belong to Costaș, Negru & Asociații, reproduction is permitted for information purposes only and with full and correct citation of the source.
