The cross-border that became a European law in 2013 has many valuable provisions but its implementation seems almost impossible due the complex European health care reimbursement systems, lack of information for patients, delay in establishing Eur. Reference Centers,
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The Challenges of Cross-Border Healthcare Law
1. The challenges of
Cross-Border Healthcare Law
An opportunity or a fallacy?
Annual General Meeting 2014
Bucharest-Romania
Kathi Apostolidis – Vice President ECPC
2. Patient Rights
• Right to decide where to be treated
• Right to obtain copy of medical records
• Right to privacy
• Non discrimination for cost & treatments on
the basis of nationality
• Right to complaint and to seek redress
• Right of appeal on authorisation and
reimbursement decisions
3. Who knows IT?
Two pieces of EU legislation in validity
• Regulation 883/2004 on the coordination
of social security systems
• Directive 2011/24/EE on the application of
patient rights to cross border healthcare
4. Differences between the
Regulation & the Directive
• Regulation> Only public healthcare providers covered
Directive> covers both public & private healthcare
providers for both planned & unplanned care
• Regulation foresees prior authorisation, which may be
required under the Directive
• Regulation> covers all healthcare costs incurred in
another MS,
• Directive> only at the cost the same services would
have in the country of the patient
• Directive> more support to patients National Contact
Points, European Reference Networks
5. From declaration to reality
Article 6: National Contact Points for Cross-Border
Healthcare
...Member States shall ensure that the national contact
points consult with patient organizations......
... In order to enable patients to make use of their rights
in relation to cross-border healthcare, national contact
points in the member state of treatment shall provide them
with information concerning healthcare providers,.....as
well as information on patients’rights, complaint
procedures & mechanisms for seeking remedies.....
7. Οbligations of the member states
• rules concerning the
reimbursement of costs of
cross-border healthcare
• responsibilities of the
Member States with regard
to cross-border healthcare
• cooperation between
healthcare systems.
Prior authorization
What & how much is re-
imbursed
National Contact Points
European Reference
Networks
Interoperability of healthcare
systems for the exchange of
documents
8. Rules on the reimbursement of costs
of cross-border healthcare
MS have two instruments to reduce access &
re-imbursement
Prior authorization
Eligible cost and level of re-imbursement
9. Responsibilities of MS
with regard to cross-border healthcare
• National Contact Points
• European Reference Networks
10. Cooperation
between healthcare systems
• Interoperability of European healthcare
systems
• ehealth
• Quality and safety guidelines
• Cross border care in border regions
• Health technology assessment.
• Need for culture of trasparency &
collaboration
11. European citizens remarks
on the Directive
• Slow and non transparent transposition
procedure
• Non involvement of citizens’organizations
• Lack of information to patients & citizens on
their rights
• Need for multi-language Information about the
Directive and health care providers
• Need for user friendly, high quality, effective &
in lay language information on NCP websites
13. How patient organisations
can help improve the implementation
• Get well informed
• Start a dialogue with membership & other
patient and citizens’ organizations
• Set an appointment with the Head of the NCPs
• Requested to be consulted by the NCP on issues
relevant to your expertise
• Propose concrete measures for improving and
accelerating patient safety, quality of care,
access & reimbursement
14. How patient organisations
can help improve the implementation
• Keep a record of reported issues by patients
who have had cross-border care
• Ask other organizations for similar records
• Send your findings to the Commission
• Commission welcomes feedback from
patients to assess effectiveness of
implementation
15. Thank for your attention
CHAMPIONING THE INTERESTS OF EUROPEAN CANCER PATIENTS
email : kathi.apostolidis@ecpc.org
@cancereu
European Cancer Patient Coalition
ECPCtv
Editor's Notes
Good morning ladies and gentlemen,
Patients and patient organizations across Europe welcomed last year the decision to make the Directive on the application of patient rights to cross border healthcare a European law .
They expected that after October 25, 2013 it would be much easier for European patients to seek treatment in another Member State.
The Directive on patients’ rights in cross-border healthcare is an important achievement of the ‘patient empowerment’ policy of the EU and an essential requirement enabling European citizens to benefit from cross-border healthcare services. It is a natural extension of the fundamental freedoms enshrined into the EU Treaties.
Τhe Directive on the application of patients’ rights in cross-border healthcare aims to establish clear rules to facilitate access to safe and high quality health services in the European Union, guaranteeing mobility of individuals/patients seeking health services in another Member State from that of their origin.
Patients under the Directive have a number of rights, but are patients informed about these rights? Are all other health care stakeholders informed about these patient rights and their obligation to respect them? the issue is how easily patients can exercise those rights. When they do exercise their rights under the Directive is there adequate information and support to guide them?
Deciding on the appropriate coverage for cross border healthcare is not easy for the European patient. All the more since two different instruments are in validity: the regulation and the directive. How patients will make sense of legal documents?
The European legislation and rules are not transparent to European citizens and the existence of two pieces of legislation governing cross border healthcare with different rules i.e. only adds to lack of clarity for patients. Will the National Contact Points explain to interested patients that there are two systems and that they may choose under which piece legislation they might seek treatment in another EU member state? How patients and families will be helped to understand which of the two possibilities is better for their particular circumstances?
The differences among the two systems of cross border care are not easy to evaluate in financial or other terms for the average patient, since many factors are
Article 6 provides for the detailed and specific information of patients by a new structure the NATIONAL CONTACT POINTS. Are they all in place seven months after the
expiry date for transposition? The reality is that many questions remain unanswered for those needing treatment in another EU member state. When in October 2013 the transposition into national legislation of he member states expired, few of t he 28 member states had transposed the directive, 30 months after the EU had agreed to the rule, and even those were not ready to face all the details its implementation encompasses. Few National Contact Points are equipped to answer all questions of patients. How the continuity of care will be assured when they returned to their country of origin?
Does the brochure offer answers to all patients’ questions? One could hardly support this. Two many issues remain open or are patient’s responsibility. Are patients really able to go to another EU member state for treatment? How they will make a decision? Will they be re-imbursed for the cost of care abroad? How they will know that the specialist they will visit in another country is really a specialist?
Nothing is made easy for the patients seeking treatment abroad. Patients will bear the responsibility for many of the elements involved in accessing planned treatment across borders:
The responsibility to find information on potential treatments
The responsibility to find the HCP who delivers the chosen treatment
The burden to obtain prior authorization
the burden of proof in demonstrating to insurers that the treatment has been carried out and
the responsibility to submit the correct documentation
the financial burden to cover cross border care costs not covered under the direc
Member states have used the prior authorization, the eligible costs and the level of re-imbursement as measures for reducing the flow of patients from countries with low level of health care services to those with modern high technology ones, or from countries with long waiting lists to countries with adequate admission times. Both the regulation and the directive provide for measures aiming to reduce the burden on healthcare systems from patients using cross border health care.
Art 4 of the Dir. Stipulates that Member States shall ensure that the national contact points consult with patient organisations, healthcare providers and healthcare insurers.
However very few of the 28MS have consulted with patient organizations during the transposition period, and the overwhelming majority of the patient organizations did not know that their health authority had the obligation to consult with them.
The Directive clearly states that the “Member States shall ensure that the national contact points consult with patient organisations, healthcare providers and healthcare insurers”. The NCPs are conceived as information focal points for health care services in other EU members states covering a wide array of information services
They inform citizens about their rights and obligations in regard to cross border healthcare
• They refer citizens to other pertinent authorities for more information.
• Patients will be able to complain and seek redress if not satisfied
• All treatment must be covered by liability insurance or similar guarantee
• Prescriptions issued in one member state, will be recognized in another
Art 4 of the Dir. Stipulates that Member States shall ensure that the national contact points consult with patient organisations, healthcare providers and healthcare insurers.
However very few of the 28MS have consulted with patient organizations during the transposition period, and the overwhelming majority of the patient organizations did not know that their health authority had the obligation to consult with them.
Currently it is clear what European Reference Networks mean since there are no agreed terminologies nor agreed standards to define highly specialized centers. Art. 12 of the Dir. Foresees that the Commission will define the criteria that the ref. networks and health centers members of the networks should fulfill. The primary aim of the ERN will be to benefit European citizens, allowing them to be referred to qualified centers of expertise within EU.
The implementation and clarification of the many details of the Directive requires the close and genuine collaboration of MS at all levels and among all stakeholders of every MS. Issues like electronic transfer of documents, uniform quality and safety guidelines, are not yet here.
Patient self-guidance in the choice is a possible critical issue