Transcript Dr. Dimitrios Kremalis, LL.M Lecturer of Health Law

Dr. Dimitrios Kremalis, LL.M
Lecturer of Health Law,
University of Peloponnese, Greece
Partner, KREMALIS Law Firm
[email protected]
Access to healthcare providers: implementation of
Regulation (ΕC) 883/2004 and Directive 2011/24/ΕU
Contribution to the TRESS Conference, Athens 27.06.2012
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
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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
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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
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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
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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
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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
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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
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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
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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 crossborder 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.