In 2008, the Commission adopted a proposal for a Directive on the application of patient’s rights in cross-border healthcare. The proposal aims to help patients exercise their rights to cross border health care in order to codify the case law of the EU Court of Justice.
The EU Member States have been widely divided on the need for such legislative proposal and on how this area should be regulated. Several Member states fear loss of national sovereignty over healthcare and that such proposal could have a negative impact on their ability to organise their respective national health systems or on the safety and security of patients. Nevertheless, the European Parliament and the Council reached an agreement on the proposal last December, and the European Parliament has recently endorsed the compromise deal, adopting, at second reading, the proposal. The Council is expected to formally adopt the Directive in March. Then, the Member States will have till 2013 to transpose it into national law.
The Commission’s original proposal would have made more difficult for the Member States to require prior authorisation for reimbursement of hospital treatment provided in another Member State, restricting, in this way, the Member States responsibility for deciding entitlement to healthcare. The Council was, therefore, able to water down the Commission proposal.
The rights of patients who seek/receive cross-border healthcare should be protected but one could wonder if the draft directive would protect those rights whilst ensuring the Member State’s responsibility for the organisation and delivery of health services and medical care. The new text is definitely a more acceptable version comparing to the Commission original proposal. But it is far from ensuring us that such measures will work.
According to the European Commission just 1% of patients seek treatment in other member state, which costs national healthcare systems around €10 billion a year. It has been estimated that under the new directive the costs increase will be up to €30 million a year. According to a Eurobarometer 53% of EU citizens are willing to receive medical treatment abroad.
The Directive will create further bureaucratic and administrative burdens for the UK health commissioning bodies. There would be further costs in administering mechanisms for reimbursing costs. It seems there will be a huge administrative burden to keep a system to just a few. In the other hand, if there is a wave of ´health tourism´ and the number of foreign patients increases this would have a negative impact on NHS.
The Commission has said “the Directive fully respects the differences of national health-care systems and the Member States' responsibilities for organisation and delivery of health services and medical care.” However, the wording of the Commission’s draft proposal could not guarantee this. But, it is now specified in the draft directive that it “establishes cooperation mechanisms on healthcare between Member States, whilst fully respecting national competencies in the organisation and delivery of healthcare.” The Council was also able to include a provision, which provides that the proposal “shall not affect laws and regulations in Member States relating to the organisation and financing of healthcare in situations not related to cross-border healthcare.”
The present draft Directive, for the purpose of reimbursing cross-border healthcare, not only covers situations where the patient receives healthcare provided in another Member State but also health goods, including prescriptions. The European Parliament and the Council amended the Commission proposal in order to specify that the directive shall not apply to health services in the field of long-term care, including services provided over an extended period of time whose purpose is to support people in need of assistance in carrying out daily routines. Under the compromise deal, the Directive does not also apply to organ transplants and, at the Council request, to public vaccination programmes against infectious diseases.
The Member State of treatment is defined as the Member State where cross-border healthcare is actually provided. The proposal specifies that the legislation of the Member State of treatment shall apply to cross-border healthcare. The Member State of treatment shall ensure that patients receive, if requested, information on standards and guidelines as well as information on which healthcare providers are subject to those standards. Moreover, patients shall get information by healthcare providers on the healthcare availability that they provide, including information on prices.
In fact, Member States would be required to establish national contact points for cross-border healthcare to provide patients with information such as reimbursement procedures as well as practical assistance.
The Council and the European Commission have different views on the issue of prior authorisation for reimbursement of health care costs. At the Council request, it is now provided in the Directive that the Member State of affiliation is the one responsible to determine, whether at a local, regional or national level, healthcare for which an insured person is entitled to reimbursement of costs and the level of reimbursement of those costs, regardless of where it is provided.
It was agreed that the obligation to reimburse cross-border healthcare is limited to the healthcare that is among the benefits to which the patient is entitled within its Member State of affiliation. The Member State of affiliation shall, therefore, reimburse the costs of cross-border healthcare up to the level of costs that would have been assumed by it, had this healthcare been provided in its territory without exceeding the actual costs of healthcare received. Member States may decide to reimburse other costs, such as accommodation and travel costs but they will not be obliged to do it as the MEPS have requested.
The draft directive provides that “Member States may adopt provisions in accordance with the Treaty aimed at ensuring that patients enjoy the same rights when receiving cross-border healthcare as they would have enjoyed if they had received healthcare in a comparable situation in the Member State of affiliation.” However, it is difficult to foreseen how member states will apply such provision.
The Member State of affiliation may impose on a patient-seeking healthcare provided in another Member State, its general conditions as well as its criteria for eligibility and regulatory and administrative formalities for receipt of healthcare and reimbursement of healthcare costs providing that “such conditions are necessary, proportionate to the aim and are not discretionary and discriminatory.” This may include the requirement to consult a general practitioner before consulting a specialist or before receiving hospital care, if this is necessary for determining the individual patient’s entitlement to healthcare.
The Member State of affiliation would not be allowed to make the reimbursement of costs of cross-border healthcare subject to prior authorisation except in the cases foreseen in the Directive. However, at the Council request, the Member State of affiliation “may limit the application of the rules on reimbursement for cross-border healthcare” if this can be justified by overriding reasons of general interest. But, such restriction on the reimbursement of costs shall be limited to what is necessary and proportionate and cannot constitute arbitrary discrimination.
Member States would be, therefore, required to put in place a mechanism for calculation of costs that are to be reimbursed for healthcare provided in another Member State, which shall be based on objective, non-discriminatory criteria, and it shall be known in advance.
The Member States of affiliation may provide for a system of prior authorisation for reimbursement of costs of cross-border healthcare. The systems of prior authorisation shall be, under the draft directive, limited to what is necessary and proportionate and not constitute arbitrary discrimination or an unjustified obstacle to the free movement of persons. Furthermore, the criteria to grant prior authorisation must be justified in the light of the overriding reasons of general interest, including “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, so far as possible, any waste of financial, technical and human resources.” Member States would 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.” Hence, under the compromise deal a prior authorisation may be refused by the Member State of affiliation for different reasons including: the healthcare can be provided on national territory within a time-limit which is medically justifiable, if according to a clinical evaluation, the patient or the general public will be exposed to a safety risk as a result of the cross-border healthcare in question and if the healthcare providers meant to provide treatment raise serious concerns as regard the respect of standards and guidelines on quality of care and patient safety, established by the Member State of treatment. It will be difficult for member states to apply such provision as their refusal to grant prior authorisation for treatment in another Member State must be based on objective evidence of their serious and concrete concerns about healthcare providers in the Member State of treatment in question.
Nevertheless, if a Member State has established a system of prior authorisation the costs of hospital care provided in another Member State shall be reimbursed by the Member State of affiliation up to the level of costs that would have been taken had the same treatment been provided at home.
Member States would be required when establishing 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. At the European Parliament request, the Member States’s individual decisions on the use of cross-border healthcare and reimbursement of costs of healthcare incurred in another Member State must be “ properly reasoned”. In fact, any administrative decisions regarding the use of healthcare in another Member State as well as reimbursement of costs, shall be subject to administrative review as well as being capable of challenged in judicial proceedings.
Under the draft proposal patients would pay in advance for cross border treatment and then be reimbursed by national health authorities. Member States of affiliation would be required to “ensure that patients receive reimbursement without undue delay.”
The draft proposal also provides for the recognition of prescriptions issued in another Member State. In order to implement this provision the Commission would adopt measures, through delegated acts, which would enable the health professional to verify the authenticity of the prescription. Whereas the Commission has proposed to develop a Community prescription template, under the compromise deal, the Commission will develop “a non-exhaustive list of elements to be included in the prescriptions.” At the Council request, Member States would not be obliged to reimburse an insured person for a medicinal product prescribed in the Member State of treatment if it is not amongst the benefits provided to that person by the Member State of affiliation.