Regional Health Conference on Health InsuranceSarajevo, 06-07 July 2011Tomislav Sokol LL.M.,

PhD Researcher at KU Leuven Institute for Social Law, Lecturer at Zagreb School of Economics and

Management

PATIENT MOBILITY IN THE EU: PLANNED HEALTH CARE

EU FRAMEWORK� 1. Treaty Framework

� 2. Coordination rules of the EU

� 3. Case-law by the Court of Justice, mainly applying freedom to provide services

� 4. Patient Mobility Directive

1. TREATY FRAMEWORK� art 168 TFEU – public health

� art 153 TFEU – harmonisation of social security

� art 48 TFEU – social security coordination for employed and self-employed workers

� art 21(3) – social security coordination for professionally non-active persons

1. TREATY FRAMEWORK� art 114 TFEU – harmonisation related to internal

market

� art 115 TFEU – harmonisation related to internal market

� art 352 TFEU – where Treaties have not provided necessary powers

1. TREATY FRAMEWORK� art 56 TFEU – freedom to provide and receive services

� art 34 TFEU – free movement of goods

� Charter of Fundamental Rights of the EU

2. COORDINATION REGULATIONS� Regulation 1408/71 and its Implementing Regulation

574/72

� Regulation 883/2004 became applicable after its Implementing Regulation 987/2009 entered into force – 01 May 2010

2. COORDINATION REGULATIONS� planned health care:

When a person insured in Member State A(competent state) travels to the Member State B for the purpose of obtaining a health treatment there, he/she must ask for prior authorisation from his/her health insurer, in order to get the social coverage of the treatment (applies also to family members). That authorisation must be granted 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 cannot be given such treatment within a time-limit which is medically justifiable, taking into account his current state of health and the probable course of his illness.

2. COORDINATION REGULATIONS� planned health care for pensioners:

When a pensioner receiving pension from Member State A travels to the Member State B for the purpose of obtaining a health treatment there, he/she must ask for authorisation from the competent institution of Member State A. The requirements for granting the authorisation are the same as for insured persons, and the tariffs of Member State B are applicable. If the pensioner has residence in a Member State C, which receives reimbursement from Member State A on the basis of fixed amounts, Member State C is considered to be the competent state. This also applies to family members.

2. COORDINATION REGULATIONS - OVERVIEW

� prior authorisation required for non-urgent treatments, entitlement to reimbursement if refused unlawfully

� state of treatment rules and tariffs applicable; competent state’s if higher than in the state of treatment (up to the level of actual cost)

� competent state pays the state of treatment’s insurer

� only providers affiliated with the state of treatment social security system

� travel and accommodation costs which are inseparable from the treatment covered, if covered domestically

3. CASE-LAW

� several judgements applying primary EU law (mainly freedom to provide services) on social coverage of foreign treatments

� starting with:

� C-120/95 Nicolas Decker v Caisse de maladie des employés privés[1998] ECR I-1831 – free movement of goods

� C-158/96 Raymond Kohll v Union des caisses de maladie[1998] ECR I-1931 – freedom to provide services

3. CASE-LAW � ECJ: mandatory prior authorisation an obstacle to the

internal market (Kohll)

� ECJ: can be justified by the need to protect the financial stability of the system and the balanced medical and hospital service open to all (Kohll, C-157/99 Geraets-Smits)

� ECJ: prior authorisation condition possible for hospital services and treatments encompassing major medical equipment, but not for other non-hospital services and in cases of urgency (C-385/99 Müller-Fauré,C-512/08 Commission v France and C-173/09 Elchinov)

3. CASE-LAW � ECJ: authorisation must be given if the same or equally effective

treatment cannot be provided in the competent state without ‘undue delay’, taking into account patient’s medical history, degree of pain, the ability to conduct a professional activity (Müller-Fauré)

� ECJ: same criteria under coordination rules and under primary law (C-372/04 Watts)

� ECJ: prior authorisation scheme must be based on objective, non-discriminatory criteria known in advance, so that the authorities’discretion is not used arbitrarily (Müller-Fauré, Elchinov)

- the authorisation system must be based on a procedural system which is easily accessible and capable of ensuring that a request for authorisation will be dealt with objectively and impartially within a reasonable time

3. CASE-LAW� ECJ: reimbursement according to domestic (competent

state) legislation, patient must pay upfront

� ECJ: patient entitled to the difference between the higher domestic coverage and lower state of treatment coverage under free provision of services and coordination rules (C-368/98 Vanbraekel)

� ECJ: reimbursement up to the level of the real cost of the treatment if coverage and cost higher in the competent state (Watts, C-512/08 Commission v France)

3. CASE-LAW� ECJ: patient is entitled to the reimbursement of

ancillary travel and accommodation costs if that right is granted for treatment within the competent state (Watts)

� ECJ: avoiding disadvantageous treatment of health care abroad (Watts)

3. CASE-LAW� ECJ: ‘Community law cannot in principle have the effect of

requiring a Member State to extend the list of medical services paid for by its social insurance system.’(Geraets-Smits)

� ECJ: Member States free to determine the package of socially covered health treatments – must comply with the EU law (Geraets-Smits)

� ECJ: packages must be based on objective, non-discriminatory criteria – ‘international medical science’(Geraets-Smits)

3. CASE-LAW

� EFTA Court: If an adequate domestic treatment is available in medically justifiable time and the foreign treatment is equally effective, the Member State can refuse to cover the expenses of the foreign treatment. This rule applies even when the foreign treatment is available sooner than the domestic treatment.

� EFTA Court: If the foreign treatment is more advanced, according to international medicine, than the domestic treatment, then ‘the State may no longer justify prioritising its own offer of treatment.‘

3. CASE-LAW� C-173/09 Georgi Ivanov Elchinov v National

Health Insurance Fund (ECJ 05 October 2010)

� Bulgarian patient obtaining a treatment for an eye tumor in Germany; alternative in Bulgaria removing the eye

� vague and broad definition of coverage in Bulgarian legislation

3. CASE-LAW� in cases where national legislation does not contain

detailed lists of precise covered health care treatments (but broader definitions, of types of diseases, for instance), the national social security system is obliged to cover the most effective health treatment available within the EU, which falls within the broad national definitions, even if that treatment is not provided on the territory of the competent state

3. CASE-LAW� What is the real scope of Member States’ freedom

to define their social packages?

� medical conditions v. medical treatments

� return to Pierik?

� crucial importance of legislative methods and phrasing

3. CASE-LAW - OVERVIEW� prior authorisation required for non-urgent hospital

and treatments involving major medical equipment� competent state rules and tariffs applicable (up to

the level of actual cost)� patient pays upfront and receives reimbursement

from the competent state� all providers who legally provide health care in the

state of treatment� travel and accommodation costs covered, if

covered domestically

4. PATIENT MOBILITY DIRECTIVE� 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 [2011] OJ L88/45

� emphasis on health care obtained outside the competent state (Member State of affiliation)

� parallel to coordination

� transparency and administrative cooperation (national contact points)

� non-discrimination by the state of treatment

4. PATIENT MOBILITY DIRECTIVE� rules on social coverage of health treatments apply to

persons to whom EU rules on social security coordination are applicable, including third country nationals (non-EU), and also to third country nationals who satisfy the conditions of the competent state (state of affiliation) for entitlement to health care benefits

� covers health care provided by any natural or legal person, or an entity, which is legally providing health care in a Member State

4. PATIENT MOBILITY DIRECTIVE� Not covered:

� (a) services in the field of long-term care the purpose of which is to support people in need of assistance in carrying out routine, everyday tasks;

� (b) allocation of and access to organs for the purpose of organ transplants;

� (c) with some exceptions, public vaccination programmes against infectious diseases which are exclusively aimed at protecting the health of the population on the territory of a Member State and which are subject to specific planning and implementation measures

4. PATIENT MOBILITY DIRECTIVE

� Member State of affiliation must be the one that is competent to grant prior authorisation under coordination rules

4. PATIENT MOBILITY DIRECTIVE� ...if a Member State is listed in Annex IV to Regulation

(EC) No 883/2004 and in compliance with that Regulation has recognised the rights to sickness benefits for pensioners and the members of their families, being residents in a different Member State, it shall provide them healthcare under the Directive at its own expense when they stay on its territory, in accordance with its legislation, as though the persons concerned were residents in the Member State listed in that Annex

4. PATIENT MOBILITY DIRECTIVE� … if the healthcare provided in accordance with the

Directive is not subject to prior authorisation, is not provided in accordance with Chapter 1 of Title III of the Regulation (EC) No 883/2004, and is provided in the territory of the Member State that according to that Regulation and Regulation (EC) No 987/2009 is, in the end, responsible for reimbursement of the costs, the costs shall be assumed by that Member State.

� This Member State may assume the costs of the healthcare in accordance with the terms, conditions, criteria of eligibility and regulatory and administrative formalities that it has established, provided that these are compatible with the TFEU

4. PATIENT MOBILITY DIRECTIVE� prior authorisation includes health care which:� (a) is made subject to planning requirements relating to the object of ensuring

sufficient and permanent access to a balanced range of high-quality treatment in the Member State concerned or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources and:

� (i) involves overnight hospital accommodation of the patient in question for at least one night; or

� (ii) requires use of highly specialised and cost-intensive medical infrastructure or medical equipment;

� (b) involves treatments presenting a particular risk for the patient or the population, or

� (c) is provided by a healthcare provider that, on a case-by-case basis, could give rise to serious and specific concerns relating to the quality or safety of the care, with the exception of healthcare which is subject to Union legislation ensuring a minimum level of safety and quality throughout the Union

4. PATIENT MOBILITY DIRECTIVE� defined list of grounds for refusal of authorisation

� state of affiliation must provide for administrative procedures, related to coverage of cross-border health care, which are objective, non-discriminatory and proportionate

� the procedures must prescribe reasonable periods of time (no concrete deadlines in the Patient Mobility Directive) to deal with requests for cross-border health care, and be made public in advance

� the decisions must be subject to case-by-case review and judicial control (including interim measures)

4. PATIENT MOBILITY DIRECTIVE� reimbursement according to state of affiliation legislation,

patient must pay upfront

� patient entitled to the difference between the higher domestic coverage and lower state of treatment coverage

� reimbursement up to the level of the real cost of the treatment if coverage and cost higher in the state of affiliation

� coverage of travel costs ambiguous

4. PATIENT MOBILITY DIRECTIVE� Member States of affiliation should give patients the right

to receive at least the same benefits in another Member State as those provided for by the legislation of the Member State of affiliation

� if the list of benefits does not specify precisely the treatment method applied but defines types of treatment, the Member State of affiliation should not refuse prior authorisation or reimbursement on the grounds that the treatment method is not available in its territory, but should assess if the cross-border treatment sought or received corresponds to benefits provided for in its legislation

� local-level decision-making emphasised

4. PATIENT MOBILITY DIRECTIVE-OVERVIEW

� prior authorisation required for hospital (overnight stays) and other cost-intensive treatments, in cases of health hazards and unsuitable providers

� competent state rules and tariffs applicable (up to the level of actual cost)

� patient pays upfront and receives reimbursement from the competent state

� all providers who legally provide health care in the state of treatment

� coverage of travel and accommodation costs unclear

4. PATIENT MOBILITY DIRECTIVE -PROBLEMS

� Member State of affiliation is the one that is competent to give prior authorisation under coordination rules – issue of pensioners living abroad (compromise)

� parallel existence of two different systems of social security coverage of foreign health treatments – tariffs and requirements for prior authorisation

� if the national list of benefits does not specify precisely the treatment method applied but defines types of treatment, the Member State of affiliation should not refuse prior authorisation or reimbursement on the ground that the treatment method is not available in its territory -interpretation

� lack of definition of ‘international medical science’ and ‘international medical standards’

GENERAL ISSUES� What is the real scope of Member States’ freedom to define

their social security health care coverage?

� definition of covered health care crucial (treatments v conditions, international medical standards)

� applicable legislation (tariffs) – danger for the poorer Member States

� using cooperation between social security systems to tackle the lack of resources?

Thank you for your attention!

Contact info:tomislav.sokol@student.kuleuven.be