Transcript TAIEX workshop April 2015 THx

TAIEX Workshop on the CrossBorder Healthcare Directive
Ankara, Turkey, 27-28 April 2015
Topic 3: Reimbursement of Costs of
Cross-Border Healthcare
Professor Tamara Hervey, Jean Monnet
Professor of EU Law and Head of School,
School of Law, University of Sheffield, UK
[email protected]
Outline
1. The ‘general principle’
2. Regulation 883/2004 and Article 56 TFEU
1. Undue delay
2. Amount of reimbursement
3. Prior authorisation
4. The ‘basket of care’
5. Conclusions
The ‘general principle’
Article 7
General principles for reimbursement of costs
1. Without prejudice to Regulation (EC) No
883/2004 and subject to the provisions of Articles
8 and 9, the Member State of affiliation shall
ensure the costs incurred by an insured person
who receives cross-border healthcare are
reimbursed, if the healthcare in question is
among the benefits to which the insured person
is entitled in the Member State of affiliation.
Reimbursement of costs
• Same basis as entitlement within the MS
• Assessment by health professional or
administrator
• If assessments are ‘obstacles’ to free
movement, must be objectively justified
• Justifications by ‘planification’, ensure
sufficient access to healthcare, control costs,
avoid waste of resources
Reimbursement of costs
• Only up to the level of costs that would have
been paid in the home MS
• Only for actual healthcare, not associated
costs, unless MS chooses otherwise
Subject to 3 key exceptions
• It applies “without prejudice to Regulation
883/2004/EC” (the relationship with Regulation
883/2004)
• It is subject to the provisions on prior
authorization in Directive 2011/24/EU, Articles 8
and 9 (the prior authorization rules)
• It applies only to circumstances where “the
healthcare in question is among the benefits to
which the insured person is entitled in the
Member State of affiliation” (the “basket of
care”)
Relationship with Regulation 883/2004
and Article 56 TFEU
• Regulation 883/2004 (ex Regulation
1408/71/EEC) oldest part of EU law on mobile
patients
• Free movement of workers and self-employed
in practice
• Coordination of social security entitlements
between MS
• Broad personal scope and material scope
Regulation 883/2004
• Based on non-discrimination, aggregation of
benefit rights, exportability of benefits, ‘single
state’ rule for affiliation
• Generally applies to person moving not as a
patient, but as a worker, self-employed person,
family member, or travelling for pleasure
• Right to healthcare for workers and selfemployed as if insured in MS of residence
• Right to emergency
healthcare during a stay in a MS
Regulation 883/2004
• Rights where travel to another MS for the
purpose of receiving healthcare/medical
treatment
• MS may authorise treatment – retain control
• MS must authorise treatment (Article 20 (2)):
(a) the treatment in question is covered by the
home Member State’s health care system and (b)
where the patient cannot be given such
treatment within a medically justifiable timelimit, taking into account his or her current state
of health and the probable course of his illness
Article 56 TFEU
• Prohibits ‘restrictions’ on freedom to provide
services
• Includes freedom to receive services
• Very broad definition of ‘restriction’ – in line
with its aim
• Any measures which make provision of
services between MS more difficult than
within one MS
Article 56 TFEU
• Non-contentious (generally) for private
healthcare
• Since 1990s, also applies to healthcare
reimbursed by national health (insurance)
system
• Surprising, because ‘remuneration’ needed
• National health (insurance) systems organised
on solidarity – assumed no ‘remuneration’
• But CJEU held otherwise in Kohll case
Article 56 TFEU
• It follows that application of the prior
authorisation rules under Regulation
883/2004/EC may in itself be a ‘restriction’ in
the sense of Article 56 TFEU, wherever such a
system of prior authorisation ‘prevents or
deters’ patients from seeking health care from
providers in other Member States
Reg 883/2004 & Article 56
• CJEU stresses interconnected
• Also stressed in Directive 2011/24/EU
• Article 56 does not invalidate Regulation – rather
they must be interpreted consistently
• CJEU has considered:
– the question of what counts as ‘undue delay’ so as to
require an authorization to receive cross-border care;
– the amount of reimbursement to which a patient is
entitled;
– the question of when an authorization system is
justified; and
– the ‘basket of care’ that is covered by a health system.
‘Undue delay’
• Inizan and Watts – ‘within the time normally
necessary for obtaining the treatment in
question’ from the Regulation interpreted as
‘without undue delay’ in cases involving
Article 56 TFEU
• Must be individual assessment of the patient
• General rules about waiting times not
sufficient
Directive 2011/24, Article 8
Healthcare that may be subject to prior authorisation
5. Without prejudice to points (a) to (c) of paragraph 6, the Member State of
affiliation may not refuse to grant prior authorisation when the patient is
entitled to the healthcare in question in accordance with Article 7, and
when this healthcare cannot be provided on its territory within a time
limit which is medically justifiable, based on an objective medical
assessment of the patient’s medical condition, the history and probable
course of the patient’s illness, the degree of the patient’s pain and/or the
nature of the patient’s disability at the time when the request for
authorisation was made or renewed.
6. The Member State of affiliation may refuse to grant prior authorisation for
the following reasons:
…
(d) this healthcare can be provided on its territory within a time limit
which is medically justifiable, taking into account the current state of
health and the probable course of the illness of each patient concerned
Amount of reimbursement
• Vanbraekel - where the application of the prior
authorisation rules under Regulation
1408/71/EEC results in a lower level of cover
where treatment is received in another Member
State to that in which the patient is insured, this
constitutes a restriction in the sense of Article 56
TFEU – implies patients could make a profit
• Commission v Spain (Emergency hospital care) –
rule in Vanbraekel applies only to scheduled
treatment, not emergency treatment
Directive 2011/24, Article 7
General principles for reimbursement of costs
4. 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.
Prior authorisation
• Article 8 – MS may have a system of prior
authorisation of cross-border health care
• There is a list of types of health care that may
be subject to prior authorisation
• The list is inspired by the CJEU’s rulings
• The list goes further than
the CJEU’s rulings
May be subject to prior authorisation
• Health care that 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;”
May be subject to prior authorisation
• Health care that “involves treatments presenting
a particular risk for the patient or the
population”, or
• Health care that 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”.
MS must authorise cross-border health
care
• when the patient is entitled to the healthcare in
question in accordance with Article 7, and when
this healthcare cannot be provided on its
territory within a time-limit which is medically
justifiable, based on an objective medical
assessment of the patient's medical condition,
the history and probable course of the patient's
illness, the degree of the patient's pain and/or
the nature of the patient’s disability at the time
when the request for authorisation was made or
renewed”.
MS need not authorise
• this healthcare is to be provided by a
healthcare provider that raises serious and
specific concerns relating to the respect of
standards and guidelines on quality of care
and patient safety, including provisions on
supervision, whether these standards and
guidelines are laid down by laws and
regulations or through accreditation systems
established by the Member State of
treatment;
MS need not authorise
• “the patient will, according to a clinical
evaluation, be exposed with reasonable certainty
to a patient-safety risk that cannot be regarded as
acceptable, taking into account the potential
benefit for the patient of the sought cross-border
healthcare;
• the general public will be exposed with
reasonable certainty to a substantial safety
hazard as a result of the cross-border healthcare
in question;
MS need not authorise
• this healthcare can be provided on its territory
within a time-limit which is medically
justifiable, taking into account the current
state of health and the probable course of the
illness of each patient concerned.
National authorities must
• Consider whether a treatment
method/healthcare provided in another MS
‘corresponds to benefits provided for’ by the
home MS
• If it does, authorisation must be given under the
Regulation
• If it does not, no obligation to authorise under
the Regulation
• And no obligation to reimburse under the
Directive either
‘Basket of care’
• Case law on basket of care states nothing in
EU law requires MS to extend their
reimbursable ‘basket of care’
• But - Elchinov – a general rule excluding, in all
cases, payment for hospital treatment given in
another Member State without prior
authorisation breaches Article 56 TFEU and is
not justified
‘Basket of care’
• Elchinov para 62 “where the list of medical benefits reimbursed
does not expressly and precisely specify the treatment method
applied but defines types of treatment, on the one hand, … it is for
the competent institution of the Member State of residence of the
insured person to assess, applying the usual principles of
interpretation and on the basis of objective and non-discriminatory
criteria, taking into consideration all the relevant medical factors
and the available scientific data, whether that treatment method
corresponds to benefits provided for by the legislation of that
Member State. It also follows, on the other hand, that, if such is the
case, an application for prior authorisation cannot be refused on
the ground that such a treatment method is not available in the
Member State of residence of the insured person, since such a
ground, if it were accepted, would imply a restriction on the scope
of the second subparagraph of Article 22(2) of Regulation No
1408/71”
‘Basket of care’
• Similarly – Petru - authorisation under
Regulation 1408/71 must be given where lack
of medication and basic medical supplies and
infrastructure means that the treatment
concerned cannot be provided ‘in good time’.
This assessment must be by reference to all
hospitals in the home Member State.
‘Basket of care’
• Petru, para 36 “the second subparagraph of Article 22(2) of
Regulation No 1408/71 must be interpreted as meaning
that the authorisation necessary under Article 22(1)(c)(i) of
that regulation cannot be refused where it is because of a
lack of medication and basic medical supplies and
infrastructure that the hospital treatment concerned
cannot be provided in good time in the insured person’s
Member State of residence. The question whether that is
impossible must be determined by reference to all the
hospital establishments in that Member State that are
capable of providing the treatment in question and by
reference to the period within which the treatment could
be obtained in good time”
‘Basket of care’
• Where treatment abroad is more medically advanced than in the
home Member State, according to the internationally accepted
views of the medical profession
• “The state may no longer justify prioritizing its own offer of
treatment” (Rindal v Norway, EFTA Court, [83])
• but must interpret its list of types of treatment appropriately, taking
into account “the available scientific data” (Elchinov EU:C:2010:581,
[62])
• not simply refuse to authorise treatment on the basis that that
particular treatment is not available in the home Member State.
• Moreover, lack of medical infrastructure, medication and basic
medical supplies can be a reason that authorization must be given,
because ‘the same or equally effective treatment cannot be given in
good time’ (Petru EU:C:2014:2271, [33]) in the home Member
State.
Directive 2011/24
• Article 7
• General principles for reimbursement of costs
• 1. Without prejudice to Regulation (EC) No
883/2004 and subject to the provisions of Articles
8 and 9, the Member State of affiliation shall
ensure the costs incurred by an insured person
who receives cross-border healthcare are
reimbursed, if the healthcare in question is
among the benefits to which the insured person
is entitled in the Member State of affiliation.
‘Basket of care’
• Patients’ Rights Directive different approach
• But Elchinov and Rindal are consistent with the Patients’
Rights Directive in the sense that the list of types of
treatment is to be determined by the Member State
concerned. It is simply that the interpretation of the list is
subject to EU law on free movement.
• Thus the home Member State controls the “basket” of
health care entitlements
• The desire of a patient to consume health care services
available in another Member State, but not the home
Member State, has not been translated into a right
embodied in EU legislation to do so, or an obligation on the
Member States to pay for such treatment where desired.
Conclusions
• Directive consolidates and extends case law under
Article 56 TFEU
• Directive clarifies the relationship between that case
law and Regulation 883/2004/EC.
• Directive in the language of entitlements of patients
• But substantive content is about national health
systems
• Detail is on exceptions to patients’ rights
• In understanding the rules on reimbursement of costs
of cross-border health care, and implementing them, it
is essential to take this into account
A blank slide
TAIEX Workshop on the CrossBorder Healthcare Directive
Ankara, Turkey, 27-28 April 2015
Topic 6: Cooperation on Health
Technology Assessment
Professor Tamara Hervey, Jean Monnet
Professor of EU Law and Head of School,
School of Law, University of Sheffield, UK
[email protected]
Health technology assessment
• Article 15
• Cooperation on health technology assessment
• 1. The Union shall support and facilitate cooperation and the
exchange of scientific information among Member States within a
voluntary network connecting national authorities or bodies
responsible for health technology assessment designated by the
Member States. The Member States shall communicate their names
and contact details to the Commission. The members of such a
health technology assessment network shall participate in, and
contribute to, the network’s activities in accordance with the
legislation of the Member State where they are established. That
network shall be based on the principle of good governance
including transparency, objectivity, independence of expertise,
fairness of procedure and appropriate stakeholder consultations.
Objectives of the network
• Cooperation
• Provide comparable information on
effectiveness of health technologies
• Information analysis
• Avoid duplication of assessments
• Network receives aid
• National competence remains
Attempt at ‘EU added value’
• Individual assessments at national level
• Competing objectives balanced
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•
•
•
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Patient access to new technologies
Patient demand
Reward innovation
Cost-effectiveness to health systems
Fiscal prudence within the Eurozone
Financial sustainability of health systems
Relative efficacy
Not ‘scientific’ – many ‘political’ elements
Only technologies recognised for reimbursement will succeed
Single market in pharmaceuticals and medical devices
But no harmonised procedure for coverage within national health
systems – which is what matters in practice
Other legislation
• Transparency of Pharmaceuticals Pricing
Directive
– applies only to pharmaceuticals, not to medical
devices or equipment
– does not directly affect how national health
systems set pharmaceuticals prices
– does not directly affect HTA
– only seeks to ensure transparency – procedure
not substance
Other legislative proposals
• Proposed amendment to Transparency Directive
– attempted to reduce overlap between the marketing
authorisation procedure (at which equivalence or
similarity of assessments is already determined) and
the procedure for national health (insurance) system
pricing and reimbursement rules.
– permitted Member States to continue to use data on
equivalence or similarity as part of the health
technology assessment process
– withdrawn in March 2015
Coordination, not harmonisation
Source: Finn Børlum Kristensen, Development of European HTA: from Vision to EUnetHTA
Michael 2012;9: 147–156
http://www.dnms.no/index.php?seks_id=149347&a=1&treeRoot=147800
Barriers
• differences in the extent and scope of health
technology assessment analysis
• differences in reporting the results
• need for glossary of common terms
• need for ‘toolkit’ (a ‘series of checklists and
resources that identify or clarify the relevance,
reliability, and transferability of data and
information from existing reports’) to achieve
comparability of health technology assessments
• new information infrastructures must also be
agreed and designed
Benefits
• the EU has many health technology
assessment agencies, each producing their
own health technology assessment reports
• multiple reports are produced on the same
health technology
• if these reports could be used in different
contexts, across different Member States,
there would be a significant saving in time and
resources
Indirect effects
• sharing of information or practice envisaged under the
Directive could result in significant challenges for
national health technology assessment procedures
• particularly if such procedures currently lack full
transparency
• availability of comparable data on health technology
assessment across the EU provides political capital for
patients’ rights groups
• may affect discussions about which novel health
technologies are available within national health care
systems