Dr. Éva Lukács Gellérné Ph.D. Ministry of Human Capacities, Hungary 27th of April 2015

Prior authorisation referral (if required) in MS X Provision of health care in MS Y Return to MS x and reimburse- ment Aftercare, redress etc. Search for information (MS X) NCPs, service providers

Responsibilities of the Member States Control mechanisms (EU, patients etc.)  Legal obligation for the MSs for  Setting up the proper regulatory and institutional framework for  Completing all the foreseen requirements  To operate the whole cycle.  Failing this legal obligations ◦ MSs face infringement procedures initiated by COM (pilot, reasoned opinion, ECJ proceedings) ◦ Patients and service providers can assert the rights enshrining in the Directive before authorities and courts

Implementation (basis: adapting the national system) Insitutional framework (Changes, even setting up of new institutions) Designation, setting up of NCP (information, transparency) Health Authority, insurance funds, service providers Regulatory framework (complete screening and impact assessment) New laws, amendments, circulars: incoming and outgoing patients, recognition of prescriptions

 COM sent formal requests (reasoned opinion) to alltogether 17 MSs to notify full transposition of the Directive and to 5 MSs to notify full transposition of the Commisison Regulation (7 July 2014, 17 September 2014, 26 November 2014)  „…to date, the above Member States have not fully turned this Directive into national law, despite being required to do so by 25 October These countries have two months to inform the Commission of the measures taken to fully implement Directive 2011/24/EU. Failure to notify adequate measures could lead to the Commission referring the cases to the EU Court of Justice”. ◦ ◦ ◦

What remaines untouched by the Directive Situation of incoming patients Situation of outgoing patients

Areas Directive requirement (not others e.g. medical devices)  Set up and provision of care in the national health system (e.g. what is subject to referral, protocolls) - TFEU  Quality and safety standards of healthcare – Art. 4 (1)  Usage of official languages in the process of providing care (eg. documents, communication) - Art. 4 (5)  Complaint procedures and remedies - Art. 4. (2) c)  Privacy and confidentiality data protection – Art. 4. (2) f.  There shall be rules regulating these areas.  The competence for prescribing the concrete content of national legislation is untouced by this Directive.

Responsibilities of the Member State of treatment

 Patients treated under the Directive will need to invest a lot to cover health care costs personally prior to being reimbursed. Additionally they will need to cover travel, accommodation and accompanying persons’ expenses.  They have to pay upfront.  Ergo presumably the wealthiest patients will travel.

 „Medical tourism can become a national product in addition to tourism.”  „This has led the Polish government to sponsor campaigns, for example in Sweden, to attract foreign patients. A growing number of Danes and Germans already use Polish dental care facilities.”

◦ To provide for access in accordance with the Directive ◦ To grant certain patients’ rights explicitly during the treatment and during aftercare ◦ To regulate medical liability insurance of providers ◦ To set limitations only on the basis of „overriding reasons of public interest”

 Definition of ‚health care’ is very broad: access is granted to all types of treatments and medicines (except what is out of the scope of the Directive like organ transplantation). It is not possible to pinpoint certain services.  Personal scope is broad. EU citizens, EU and also third- country national insured persons are included in the term ‚insured person’ and they can avail themselves of the possibility to buy health care services in accordance with the Directive.  E.g. a Chinese patient (insured in MS A) wants a planned treatment (ophtalmology, usually no prior authorisation is necessary) in MS B and s/he shall be treated on the basis of equal treatment not as a private patient. New!  Services provided by private (non-contracted) operators shall also be accessible on equal footing for ‚insured persons’, e.g. spa and dentistry. New!

 Related financial question: there can not be different price categories in the state-funded system for the same treatment between insured persons in the MS and insured persons in other MSs. Those who were ‚private patients’ before now mostly became ‚insured persons of other MSs’. Category of ‚private patients’ might be shrinking.  Private (non-contracted) providers can set their prices but no distinction is allowed  Is this an extra revenue of the provider or part of the state- funded sum (especially if the care is provided entirely in a public environment (persons and equipment)?  Whether to allow state-funded access to private non-contracted providers within the state (especially in countries where the benefits are free of charge) on the basis of the Directive?

 The Directive can have an impact on domestic health policy, it might drive towards greater clarity on the definition of the benefit package for citizens.  Calculation of the internal tariff’s rate. What is included and what is not included (e.g. strictly the care or also related services like counselling about providers, rights, other supporting services, costs of personel). How medical devices, depreciation costs are calculated?  What if the former ‚private tariff rate’ was higher than the ‚internal tariff rate’? And this rate shall be the same rate what is used for outgoing patients.

Only healthcareContent is important  Art. 7 (4) states „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.  The Member State of affiliation may decide to reimburse other related costs, such as accommodation and travel costs, or extra costs which persons with disabilities might incur due to one or more disabilities when receiving cross-border healthcare, in accordance with national legislation and on the condition that there be sufficient documentation setting out these costs.”  Receipt: shall be capable of justifying the exact content of healthcare, otherwise the reimbursement in the MS or origin will not be possible. It shall make clear what health care elements / categories are covered.

 Possible areas of technical intervention: ◦ The MS of treatment can operate a control system whether the person is really an ‚insured person’ in terms of the Directive. ◦ If there is electronic data control a separate IT ‚highway’ can be established (e.g. a new code that is carried throughout the service). ◦ The calculation formula shall be built-in. ◦ The adjustment of the issuance of receipts might be necessary (e.g. in countries where the benefits are free of charge like the UK NHS system, the Spanish system and some CEE countries). The content of the receipts is very important – it shall be the basis of the reimbursement.

 Real addition to a European Framework of Patients’ Rights, aimed at providing for the same rights in the MS of care as for its own nationals.  European Charter of Patients’ Rights contains 14 rights.  Directive lays down minimum patients’ rights expressis verbis as follows: ◦ Right to access, right to information and right to free choice (informed choice) ◦ Right to privacy and confidentiality (data protection) ◦ Right to quality and safety ◦ Right to complaint and compensation  All needs to be regulated in national laws.  Transparency and legality requirement a kind of ‚precision’ of national settings.

 Art. 4 (2) 2. The Member State of treatment shall ensure that: „healthcare providers provide relevant information to help individual patients to make an informed choice, including on treatment options, on the availability, quality and safety of the healthcare 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 status, their insurance cover or other means of personal or collective protection with regard to professional liability.  To the extent that healthcare providers already provide patients resident in the Member State of treatment with relevant information on these subjects, this Directive does not oblige healthcare providers to provide more extensive information to patients from other Member States;”

 Art. 4 (3) The principle of non-discrimination with regard to nationality shall be applied to patients from other Member States.  This shall be without prejudice to the possibility for the Member State of treatment, where it is justified by overriding reasons of general interest, such as planning requirements relating to the aim 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, to adopt measures regarding access to treatment aimed at fulfilling its fundamental responsibility to ensure sufficient and permanent access to healthcare within its territory. Such measures shall be limited to what is necessary and proportionate and may not constitute a means of arbitrary discrimination and shall be made publicly available in advance.

Planning requirementsControl costs  Healthcare service providers are required to accept referrals made out to the Union patient by any competent health-care professional in any Member State of the European Union,  except if the healthcare service provider is unable to understand it or it fails to provide sufficient information regarding the patient’s condition, and hence, on the medical procedures that may be required.  If the healthcare provider has no capacity to provide for the treatment.  A healthcare service provider may refuse to provide healthcare services to a Union patient if it would jeopardize its vested obligation to maintain continuous service to patients within its own region.

Responsibilities of the Member State of affiliation

 There will be direct reimbursement costs, there might also be indirect costs, less efficient utilisation of certain infrastructure and human resources (financial sustainability issue)  At the same time patient satisfaction might be higher, choice of providers can attribute to better organisation of certain resources.  Because of lacking data the monitoring of the situation will be most decisive.

 Coverage of prior authorisation ◦ Which healthcare is accessible abroad without or with prior authorisation.  Administrative formalities before leaving and after returning for the patient  Conditions of reimbursement  Aftercare (medical follow-up) shall be provided (Art. 5 c)  Monitoring - assessment to be made whether change is normal within a deviation range or there is a significant irregularity that needs action.

 Some Member States merged the rules of the Regulation 883/2004/EC with the Directive (UK, DE, BE, PL, HU), usually a multistage procedure in which preference is given to the Regulation unless the patient declares otherwise.  Some kept distinct procedures (ES, IT, AT).  Important is that the individual retains the right to choose.

 Process usually (take the UK example) looks as follows: ◦ You get informed ( consult your GP. ◦ You will need to complete the application form (PDF, 102kb). application form (PDF, 102kb) ◦ Find out what types of services require prior authorisation (PDF, 72kb).services require prior authorisation (PDF, 72kb)  In countries with regional administrative units the situation is even more complex, e.g. there is no unified list of prior authorisation in Germany, this falls within the competence of the Lander.

Referral (to which services is it necessary), LithuaniaTranslation costs (e.g. official translation), PolandCo-payment, preliminary report, Hungary

Pre-conditionsConsultation, referral  Very important that conditions of reimbursement might be pre-conditions of accessing care in the MS of origin.  This is independent from the issue of prior authorisation.  Art. 7 (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, whether set at a local, regional or national level, 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.

 Art. 7 (9). The Member State of affiliation may limit the application of the rules on reimbursement for cross-border healthcare based on overriding reasons of general interest, such as planning requirements relating to the aim 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.  Difficult to see how these theoretical protections could be translated into practice.

 Art. 5. c) where a patient has received cross- border healthcare and where medical follow-up proves necessary, the same medical follow-up is available as would have been if that healthcare had been provided on its territory;  However, this is different from responsibility for damages caused abroad.  Example: „Note: an agreement to fund your treatment abroad by the NHS does not mean the NHS is liable for the treatment you receive.”

EU level European Commission National decision- making National authorities National implemen- tation Healthcare funds, service providers

„..one of the mechanisms to provide for information”

 Article 6  National contact points for cross-border healthcare  1. 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. The Commission and the Member States shall make this information publicly available. Member States shall ensure that the national contact points consult with patient organisations, healthcare providers and healthcare insurers.

 EU law obligation to set it up.  Aim: „..one of the mechanisms to provide for information”.  Content: ◦ the minimum (compulsory) information requirements are laid down in the Directive and in the implementing Commission Directive on recognition of prescriptions, ◦ a clear distinction shall be made between the rights which patients have by virtue of this Directive and rights arising from Regulation (EC) No 883/2004, ◦ but NCPs can provide for more information voluntarily.  The concrete form is not foreseen (separate institution/s, a designated social security institution/s).  Technical implementation through web sites, call centres and personal counselling is possible (Art. 6. information „…shall be easily accessible and shall be made available by electronic means and in formats accessible to people with disabilities, as appropriate”.) There has been an NCP websites feasibility study.

Quality and safety laid down by the Member State of treatment, including provisions on supervision and assessment of healthcare providers, information on which healthcare providers are subject to these standards and guidelines and information on the accessibility of hospitals for persons with disabilities; Art. 4 (2) a) Rights and entitlements in that Member State relating to receiving cross-border healthcare, in particular as regards the terms and conditions for reimbursement of costs in accordance with Article 7(6) and procedures for accessing and determining those entitlements and for appeal and redress if patients consider that their rights have not been respected; Art. 5 (b) Provider’s right to provide services or any restrictions on its practice, as well as information on patients’ rights, complaints procedures and mechanisms for seeking remedies, according to the legislation of that Member State, as well as the legal and administrative options available to settle disputes, including in the event of harm arising from cross- border healthcare. Art. 6 (3) Contact details of national contact points in other MSs, Art. 6 (2) and content of prescriptions (Commission Directive 2012/52/EU)

 Laying down measures to facilitate the recognition of medical prescriptions issued in another Member State:  Article 4  Information requirements  Member States shall ensure that the national contact points referred to in Article 6 of Directive 2011/24/EU inform patients about the elements to be included, pursuant to this Directive, in prescriptions issued in a Member State other than the Member State where they are dispensed.

Something useful Addition to support mobility Accessible in at least one foreign, major language Concrete guidance on forms of care, providers, waiting lists, prices. Administrative formality Level of ambition is low Control patient activism Multilingualism does not cover essential information only basics

 The two pillar of implementation is related to incoming and outgoing patients: ◦ On one hand the European Patients’ Rights aspect is strenghtened and patients have much wider choices to buy healthcare services in other EU states.  This is supported, states usually see this as a potential for medical tourism. ◦ On the other hand the ECJ’s case law is implemented and reimbursement shall be paid subject to conditions.  This is case-law since 1998 but still not unambiguously triggered.  Implementation is a process.  Monitoring is essential hence this can determine the realities of cross-border patient flows and the directions for the future.

 European Commission materials  COM(2014) 44 final (Report on obligations foreseen under Article 20(3) of Directive)  df df   COM (2012) 153 final (communication on external dimension)  n.pdf (NCP website design feasiblity study) n.pdf  National legislations  ross_Border_Healthcare_and__Patient_Mobility.pdf ross_Border_Healthcare_and__Patient_Mobility.pdf  application-form-v10.pdf (Application form) application-form-v10.pdf  tions/Transposition_and_national_level_resources.pdf tions/Transposition_and_national_level_resources.pdf  NCP information  info/index_en.htm (List of NCPs) info/index_en.htm  Other   es_co108_en.pdf (European Charter of Patients’ Rights) es_co108_en.pdf

Correspondence to: Dr. Éva Lukács Gellérné Ph.D. Thank you for your attention!