Dr. Dimitrios Kremalis, LL.M Lecturer of Health Law, University of Peloponnese, Greece Partner, KREMALIS Law Firm Access to healthcare providers: implementation of Regulation (ΕC) 883/2004 and Directive 2011/24/ΕU Contribution to the TRESS Conference, Athens

The freedom of movement and establishment traditionally coexisted within the scope of EU Law with the competence of the member states to regulate the organization and financing of their healthcare systems in an interesting if not sometimes controversial but increasingly dynamic relationship Over the years EU has ventured to develop a cohesive system of tackling the complex issues arising from patient mobility. Since the landmark Decker and Kohll cases and the more recent Watts, Stamatelaki, Van Delft and Elchinov there have been numerous cases involving freedom to provide services, goods and more recently freedom of establishment. The jurisprudence of the Court of Justice has highlighted the need for clarification with regard to the interaction between the Treaty provisions on free movement and the health services provided by the national health care systems. However, it was a strong belief of the European Leaders, as expressed in their statement on common values and principles, that developments in the field of health care should not be solely based on case law but ought to be a result of political consensus. As the European Commission has stated, the new directive will venture to provide a Union-wide framework for safe, high quality and efficient health services. The new directive, the first piece of secondary legislation on cross border health care, without going as far as to deprive the Member States of their freedom to choose the type of health care they consider appropriate, constitutes nonetheless a step forward towards the Europeanization of health care. However, the new Directive raises questions regarding its application in practice, due to the lack of comprehensive procedural provisions, and its interplay with Regulation 883/2004 on the coordination of social security systems. This contribution will venture to present the issues which may arise in Greece, acting either as state of affiliation or state of treatment, and discuss the overall impact of the two instruments on healthcare providers, as well as aspects related with the creation of a unified cross border health care system.

Interplay between the Regulations on the coordination of social security systems and the Directive on patients’ rights In each case involving patient mobility the first question that must be addressed is whether the Directive and/or the Regulations are applicable. As stated in the preamble, the new Directive does not affect the rights insured patients in respect of the assumption of costs of health care which is becomes necessary on medical grounds during temporary stay in another member state according to the Regulation. However, in the case of patients traveling for the sole purpose of receiving health care services, the two instruments may overlap. The most obvious issue arises from the process for granting prior authorization to patients planning to receive scheduled health care services in a Member State other than the Member State of affiliation as a prerequisite for receiving reimbursement from the competent state. Furthermore, since the level of reimbursement received will vary depending on the applicable legal instrument, it is evident that the interaction between the two must be further explored. While the two legal instruments complement each other, the authorization procedure provided for in the Directive and its counterpart in the Regulation 883/2004 defer significantly. According to the Regulation, insured patients traveling to other Member States to receive scheduled medical treatment ought to seek authorization from the competent institution. The competent institution is obliged to provide authorization only in cases where the patient cannot receive such treatment in the state of affiliation within a time limit which is medically justifiable. On the other hand, the scope of the authorization system under the directive is significantly narrower and evidently echoes the Court’s freedom of services jurisprudence which considers patients entitled to cross border health care. According to the Directive the prior authorization system may only include treatment involving overnight stay in hospital, or requiring highly specialized and cost-intensive infrastructure or equipment, or treatment involving particular risk to the patient, or the treatment will be provided by a health provider about whom serious concerns were raised regarding the quality of provided care. In practice, the Member states will choose and then notify the Commission for which categories of healthcare prior authorization will be required. This provision raises an interesting question. What happens when/if the directive is not implemented in time, like most cases in Greece, and the provided system of prior authorization for reimbursement of costs is not set up. In that case would that result to an obligation of the competent institutions to reimburse costs for even hospital care which includes accommodation without prior authorization?

Interplay between the Regulations on the coordination of social security systems and the Directive on patients’ rights Furthermore, according to the Directive, the Member state of affiliation may refuse prior authorization only when one or more of the patient or public health and safety reasons described in Article 8 (6) (a) – (c) may be applied or the treatment can be provided on its territory within a medically justifiable time limit. However, whatever the case is, the member of affiliation may not refuse to grant prior authorisation when the patient is entitled to healthcare which cannot be provided on its territory within a time limit which is medically justifiable, unless serious concerns regarding patient or public health and safety are raised. In the case of treatment which cannot be provided in the Member state of affiliation within a time limit which is “medically justifiable” and without “undue delay”, authorization can be granted under both legal instruments. However, in that case priority shall be given to the Regulation. As stated in the preamble of the directive “[where the patient is entitled to cross-border healthcare under both […] Directive [2011/24] and Regulation (EC) 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” so as to make the most beneficial choice. Regarding prior authorization Article 8(3) of the Directive expressly provides that the Member State of affiliation must examine first whether the conditions for implementing the Regulation have been met and, if that is the case, grant authorization on the conditions of the coordination of social security systems regime unless otherwise requested by the patient. It is however evident that in most situations patients will opt for protection under the Regulation. Reimbursement according to the Regulation has to be made on the basis of the tariffs of the country providing the treatment and consequently the full amount of costs born by the patient is covered. On the other hand, the Directive provides for reimbursement up to the level of the domestic tariffs of the Member state of affiliation.

Interplay between the Regulations on the coordination of social security systems and the Directive on patients’ rights Consequently, in the case of treatment which cannot be provided in the member state of affiliation, patients will most likely apply for and receive reimbursement under the provisions of the Regulation. According to the Regulation, insured patients who are authorized by the competent institution to travel abroad for the purpose of receiving health care shall receive the benefits in kind in accordance with the provisions of the member state of treatment. However, the treatment will be provided the contractual service providers of the competent institution of the member state of treatment. In the case where a patient, for whatever the reason, prefers to receive treatment by a different non-contractual provider then the Directive comes into play. Indeed, the Directive for the first time allows the patient to choose a specific health care provider of a Member State other than the Member State of affiliation. In that case it will only be reimbursed on the basis of the Directive which covers the costs incurred for benefits in kind received abroad up to the level of the tariff charged for that treatment in the Member State of affiliation, provided of course that the healthcare in question is among the benefits to which the insured person is entitled to in the Member State of affiliation. An interesting point here is that while the competent institutions will usually not reimburse patients who choose to receive treatment by non-contractual partners in their own state, the Directive obliges them to do so in the case of foreign non-contractual providers. The Directive in that sense provides a way for the patients to by-pass the contractual agreements of the competent institutions and receive treatment by private health care providers. Although in most cases patients will prefer to be treated as near their home as possible, there will be situations where a patient will prefer to receive treatment which can be provided in the Member state of affiliation without “undue delay” by a foreign service provider. In this situation there is no direct obligation under the Regulation to give the authorization, since the competent authority cannot be required, especially in the case of low tariff states such as Greece, to reimburse the patient for the full cost of treatment in another country when such treatment could have been provided by the competent Member State in proper time and quality.

Interplay between the Regulations on the coordination of social security systems and the Directive on patients’ rights On the other hand, under the Directive, in situations that do not fall under article 8 (2), patients will be reimbursed up to a certain point without the need of prior authorization. This aspect of the Directive provides a window of opportunity for cross border cooperation between Health providers and even competent institutions. This kind of cooperation, which already exists between the NHS and providers in Thessaloniki, will be made possible at a European level through the setting up of the European Reference Networks and the Centres of Reference. Article 12.4(a) of the Directive requires the Commission to adopt, via delegated acts, a list of criteria that the network must fulfill and the conditions which must be fulfilled by the providers wishing to join such networks. Providers which will be admitted to the network will be able to exchange information and cooperate with each other to provide a European-wide high level of health care. Additionally, patients who have to wait a significant amount of time to receive treatment for cases which have been classified as routine in their member state of affiliation, as in the landmark Watts case, may choose to receive treatment in a provider abroad that fulfills the Network’s standards of quality. Furthermore, health providers who wish to use their time and funds to treat more specialized and complex cases will be able to forward some of their routine cases to health providers abroad. As the NHS notices, countries with high tariffs will not be able to compete in that part of the health care services market and will have to focus on research, specialized and rare disease treatment. This could also benefit the competent institutions since receiving countries will most likely be countries with low tariffs. Since under the Directive the costs reimbursed will be the ones actually spent in the state of treatment, this process could actually be financially beneficial to the competent institutions while simultaneously provide high quality treatment to patients and decongest the service providers. In that sense, we may be entering a new era where the competent institutions not only will provide authorization for cross border care but they will also urge their insured patients to receive cheaper treatment abroad.

Interplay between the Regulations on the coordination of social security systems and the Directive on patients’ rights Countries, such as Greece, which have a long tradition of high quality health care services may act as havens for such type of cooperation. Greek providers will rather easily meet the Commission standards to be classified as centres of reference. In the relevant market the only real competition is providers in countries with equally low tariffs. However, this choice of policy may, in the long-term, create a two gear Union with regard to health services, consisting of the rich North which will provide highly specialized medical expertise and absorb complex cases and research funding and the poor South which will only treat routine cases.

Application/Administrative procedures The Member States decided not to include a comprehensive procedural aspect to the Directive. Article 9 merely urges the Member States to ensure administrative procedure for the use of cross border health care and reimbursement of the incurred costs is easily accessible, based on objective and non discriminatory criteria which are necessary and proportionate. The Directive provides for a two-degree procedure for administrative protection and that any individual decision must be subject to judicial review. Due to the lack of specific provisions regarding administrative and judicial protection the directive will borrow the administrative and legal instruments provided in the member state. As a result, patients asking for authorization for cross border care will, in case of refusal, have to rely on the protection provided by the member states. In the case of Greece, the two-degree administrative procedure, followed by judicial review could be very time consuming due to the notorious inefficacy of the Greek public administrations and almost paralyzed administrative justice system. As a result, the patients will mostly rely on the competent institutions good will since the directive includes many general terms which inevitably will require interpretation.

Application/Administrative procedures All things considered, the most crucial interpretation seems to be the one provided by the competent institution, which may limit patients’ rights at will by arbitrarily choosing the legal instrument applied in each situation. In addition to that, since patients will have to pay upfront for the services they wish to receive abroad, an administrative practice to deny reimbursement will render the exercise of the right to cross border health care less attractive. The fact that after judicially challenging the decision of the competent institute they will, most likely, receive compensation after three to five years is not sufficient protection for patients’ right to receive treatment abroad by a provider of his choosing. Concluding, the new Directive has significantly contributed to the creation of a unified cross- border health system within EU but left certain aspects pending especially regarding the implementing role of the competent national institutions/authorities, as well as the applicability of provisions in relation with the Regulations on the coordination of social security systems.