Back in 2008, the European Commission adopted the proposal for a Directive on Cross Border Healthcare. Two years later, is it any closer to becoming a reality? IMTJ provides an update on the latest developments in the saga of the EU Directive….
In July 2008, the European Commission adopted a proposal for a directive to help patients exercise their rights to cross border health care and to codify the case law of the EU Court of Justice. The principles of the Directive are based on Article 95 of the treaty that established the European Community. The Directive is now back on the political agenda.
In April 2009, the European Parliament approved 122 amendments to the original proposal. European health ministers made more changes in July 2010. The Council has adopted its position at first reading by qualified majority .The European Parliament’s second reading is scheduled for December 2010.
The EU member states have been widely divided on the need for this legislative proposal and how it should be regulated. Several fear loss of national sovereignty over healthcare, and have been stressing that patients should only be able to make use of cross-border healthcare, if they have received prior authorization. Last June, the Council agreed on the draft directive on the basis of a compromise proposal by the Spanish presidency.
The draft directive contains provisions on prior authorisation and reimbursement of healthcare provided in another member state. The Council and the MEPs have broadened the scope of the directive. Both specified that for the purpose of reimbursing cross-border healthcare, the present draft directive not only covers situations where the patient receives healthcare provided in another member state but also health goods, including prescriptions, dispensation and provision of medicinal products and medical devices when provided in the context of a health service. The European Parliament and the Council amended the proposal to specify that the directive shall not apply to long-term care or organ transplants or public vaccination programmes against infectious diseases.
MEPs and the Council have made amendments so the member state of treatment shall ensure that patients receive, if requested, information on standards and guidelines as well as information on the healthcare provider’s authorisation or registration status, healthcare availability, information on prices and the provider’s insurance cover. But the Council specifies that healthcare providers are not obliged to provide more information to patients from another member state than they are already providing to patients resident in the member state of treatment; nor are they obliged to provide information in other languages. Patients who have received treatment will be entitled to a written or electronic medical record of the treatment.
Under the earlier draft proposal, member states must ensure that their patients seeking to receive healthcare provided in another member state will not be prevented from receiving it; but how this can be done remains a mystery and the European Scrutiny Committee has expressed doubts over the home state’s ability to ensure that the patient is not prevented from receiving the treatment in question. So Council has not included this provision in the latest draft proposal.
The latest draft would allow patients to seek healthcare in another member state which would have been provided at home and then be reimbursed the costs of anything up to the full amount that would have been paid if they have had received that treatment at home. The Council and the European Commission have different views on the issue of prior authorisation for reimbursement of health care costs. Member states have been stressing that they should be able to make the use of cross-border healthcare subject to prior authorization. Under the Commission draft proposal there is no requirement of prior authorisation for reimbursement by the statutory social security system of a member state of affiliation for healthcare considered as non-hospital care. The Commission has asserted that a prior authorisation requirement on cross-border non-hospital care represents an obstacle to the free movement of health services that is not justified.
A member state will not be obliged to reimburse treatment provided in another member state which is not offered by its own national health system. The European Parliament agreed with the rule that patients are to be reimbursed up to the level they would have received in their home country. So member states cannot make subject to prior authorisation the reimbursement of the costs of non-hospital care provided in another member state if the cost of that care, if it had been provided in its territory, would have been paid for by its social security system.
The European Parliament has added a new provision where the member state may decide to cover not just the actual cost of treatment, but also other related costs, such as therapeutic treatment and accommodation and travel costs. MEPs have also introduced the requirement that if a member state rejects the reimbursement of a treatment it must give a medical justification for its decision, not a financial one.
The European Parliament First Reading position also provides that the member state should reimburse patients affected by rare diseases for healthcare in another member state even if that treatment is not among the benefits provided for by its legislation. MEPs specifically added, “If there are several methods available for treating a certain disease or injury, the patient should have the right to reimbursement for all methods of treatment that are sufficiently tried and tested by international medical science, even if they are not available in the patient’s member state.”
Under the draft proposal, the member state is required to ensure that patients who travel to another member state for seeking or receiving healthcare have access to their medical records. The MEPs have added a rider that the patient or patient’s relatives shall give express consent in writing before data is transmitted.
The First Reading identified that, as there is no common definition of what constitutes hospital care throughout the different health systems in the EU, so states could manipulate to their advantage what does or does not need prior authorisation. So, the Commission has introduced an EC wide definition of hospital care, “Treatment that requires at least one night of stay in a hospital or clinic. Treatment that requires the use of highly specialised and cost-intensive medical infrastructure or medical equipment or involves treatments presenting a particular risk for the patient or the population.” And the Commission plans to define a regularly updated technical list of the latter treatments. Currently, member states will be allowed to make the reimbursement of costs of cross-border healthcare subject to prior authorisation if “the treatment requires at least one night stay in a hospital, requires the use of highly specialised and cost-intensive medical infrastructure or medical equipment, or raises serious and concrete concerns related with the quality or safety of the care.”
The Council text agreed in Spain allowed member states to limit the reimbursement of cross-border healthcare if this can be justified by overriding reasons of general interest such as the risk of seriously undermining the financial balance of a social security system, or the objective of maintaining a balanced hospital service open to all. The European Parliament, at First Reading, no longer includes this get-out clause that would be triggered just by individual member states. Instead the European Parliament says that it will add this get-out for specified member states. But each state must provide evidence that due to the directive implementation the outflow of patients is likely or seriously undermines the financial balance of the social security system or the planning of hospital capacity, that there is the risk of seriously undermining the financial balance of a social security system as well as the objective of keeping on grounds of public health a balanced medical and hospital service open to all and the objective of maintaining treatment capacity or medical competence on the territory of the concerned member state, essential for the public health. The Council will then decide if they will allow the member state to add limits. In practice, it will be almost impossible for any state to get this agreed.
Member states will be responsible for establishing rules on management, requirements, quality and safety standards and the organisation and delivery of healthcare, and will individually decide whether it is necessary to introduce a system of prior authorisation, and to identify the healthcare requiring prior authorisation within the limits of the EC definition of hospital care. So individual states can either decide to not have any system of pre-authorisation, or to have a limited system, but cannot demand pre-authorisation of anything wider than the EC definition of hospital care.
The latest draft lists allowable reasons for member states to refuse prior authorization, although others may be acceptable -
No entitlement to the treatment in question.
Healthcare can be provided in the home country within a time limit that is medically justifiable.
According to a clinical evaluation, the patient or the general public will be exposed to a safety risk.
There are serious concerns on standards and guidelines on quality of care and patient safety about the specified healthcare provider.
Member states must establish time limits to deal with requests for the use of healthcare in another member state to take into account the specific medical condition, individual circumstances, and the nature of the patient's disability. Member states must specify in advance and in a transparent way the criteria for refusal of the prior authorisation. So, states cannot avoid paying by procrastinating bureaucracy, nor refuse to pay without giving detailed reasons.
Member states must make publicly available all relevant information on the prior authorisation systems. The European Parliament has introduced, at the first reading, a new provision that they must set up specific prior authorisation application systems.
The European Parliament also voted to introduce special rules for patients with rare diseases and disabilities who may need special treatment. These patients would have the right to access healthcare in another member state not subject to prior authorisation and to reimbursement “even if the treatment in question is not among the benefits provided for by the legislation of the Member State of affiliation.”
The latest draft specifies that member state national health authorities are required to take their decisions related to cross-border healthcare, including reimbursement of costs, in a timely manner and respecting the principles of objectivity, non-discrimination and transparency, as well as the circumstances of the case. The proposal provides that in general a decision regarding the cross-border healthcare should take fifteen days, but less if the treatment is urgent.
There are three key areas where MEPs, and the European Commission disagree, which will have to be discussed and agreed before the second reading-
On the question of patients paying in advance and getting reimbursed later the European Parliament has included a new provision under which member states will be allowed to offer their patients a system of voluntary prior notification. So, citizens travelling abroad for treatment would obtain approval from their health authority in advance. In return, for such notification, reimbursement would be made directly by the member state to the hospital of treatment. Leaving such patients only to pay advance or top-up payments. But the Council has rejected this amendment as impractical as the healthcare that a patient might receive abroad and the actual cost cannot be known in advance.
The European Parliament wants the Commission to carry out a study on the viability of establishing a clearing house to enable the reimbursement of costs across borders, healthcare systems and currency zones and, if necessary, to present a legislative proposal. The Council has rejected this amendment.
The European Commission wants the draft directive to become national law within twelve months of finalisation, but the Council has proposed three years.
The latest version of the draft directive will make it more difficult for member states to require prior authorisation for reimbursement of hospital treatment provided in another member state. Other get outs and freedom of individual action that the health ministers thought they had succeeded in getting agreed in Spain, have universally been stamped on by the European Parliament. But it is now clear that for pre-authorisation, patients will have to specify the actual hospital and the treatment programme. They cannot get authorization and then decide where to go. It is also very unlikely that states will, except in very special circumstances, authorize treatment outside of European member states.
The Council and MEPs have agreed on the wording of several provisions but the Council has rejected several amendments proposed by the European Parliament. It remains to be seen what will come out from the negotiations with the European Parliament, but it is clear that the latest version is much closer to the original intent than interim ones.
There are only two things we can be certain of:
the final directive will inevitably have more surprises and changes;
and that the number of people prepared to fight their way through the bureaucratic jungle will be limited.
Whether the cost and burden of administration necessary to make this work across Europe is justified by the impact on health care is debatable.