Briefing: cross border care

Introduction

In March 2011 the Council of the European Union adopted Directive 2011/24/EU ¹ on the application of patients’ rights in cross-border health care. ^a This was the culmination of over a decade of fierce political debate ² about the rights of patients to have free movement within the EU for their health care, arising from a series of rulings by the European Court of Justice dating from 1998. Member States now have until September 2013 to implement the Directive's principles in domestic law, and there has been a high level of uncertainty about the difficulties they will encounter in the process. Questions include the impact of the Directive in practice and how key stakeholders in the health system (from patients to health insurers to providers and public authorities) will react to its requirements.

Context

The implementation of the Directive is likely to throw up unexpected consequences as it interacts with other EU legislations, Member State health-care legislation, as well as different professional and system approaches to health care in Member States. To gain insights into the implementation European Health Management Association, together with European Social Observatory and Association Internationale de la Mutualité, supported financially by the Belgian National Institute of Health and Disability Insurance ^b developed a cross-border health-care simulation. ³ This simulation brought together the key stakeholders including patients, insurers/purchasers, public authorities and health-care providers to test the impact of the Directive in practice.

The simulation involved participants from six EU countries: Belgium, France, Germany, The Netherlands, Luxembourg and Spain. This cluster of countries has relatively large movement of patients between them; the mix was also designed to reflect different health systems and cultures, from health insurance to ‘NHS-type’ models. The stakeholder groups from the six countries worked together on a series of case studies designed to illuminate the key issues of the Directive. Although the simulation was the first of its kind at EU level, it proved an effective tool and highlighted real challenges for Member States and most of all for patients.

Key issues

The simulation painted a picture of the Directive that was very different from the discussions that dominated the political debate in the run-up to its adoption into European law. In some areas there was a striking consensus, which suggests that the Directive will bring substantial legal certainty. Perhaps surprisingly this includes areas where tensions in implementation might have been predicted, such as on the articulation between the Directive and Regulation 883/04, ^4,5 but where, in practice, pragmatic solutions are being found.

For other issues, while there was a large consensus within stakeholder groups, there were equally large divergences between stakeholder groups. For instance, while purchasers and public authorities made it clear that for care to be reimbursed, it should comply with the conditions as defined by the patient's Member State, the providers were equally clear that they would not adapt procedures or processes to conditions of the health insurer or payee of the foreign patient. Both payers and providers looked to the patient themselves to bridge the resulting gap. As long as the number of cross-border patients remains low, this may be solved pragmatically on a case by case basis, but it clearly creates scope for misunderstandings.

Some areas within the Directive, in particular those resulting from heavy political wrangling, were not seen to be particularly relevant at a practical level. This includes the provisions allowing Member States to prevent high inflows of patients under certain conditions. It was clear from the simulation that few if any Member States have the means to track the number of foreign patients using health care in their country, let alone a system for regulating that flow, and thus it was difficult to see how these theoretical protections could be applied in practice.

However, in other areas the implementation of the Directive may have an important and largely unpredicted impact on domestic health policy. For example, it is likely to drive Member States towards greater clarity on the definition of the benefit package for citizens, as inclusion of a given treatment in the existing benefit package is a prerequisite for funding of care abroad under the Directive. This greater clarity in turn may prompt discussions and changes in entitlements for domestic patients who never leave their own country.

Impact on patients

Among all the groups affected by the Directive, patients seem likely to bear the brunt of the implementation. Where the payers, providers or Member States are unable to agree or lack the means to manage the flow of cross border care, the burden is likely to fall back onto the patients.

For example, patients will bear the responsibility to find information on potential treatments and provider, they will also be responsible for putting together the burden of proof to demonstrate to insurers or payers what treatment has been carried out and the responsibility to submit the correct documentation, including medical records and ensuring accurate translations if required.

Within the simulation it was notable that patients who go abroad for treatment under the directive were in many ways treated as if they were not part of the public system. The providers did not see any necessity to comply with the tariffs agreed within the Member State of treatment as they would for patients receiving care under Regulation 883/04. Rather, they saw themselves as able to freely set their tariffs and request additional payments as they would for domestic private patients. Although covered by the public system of their own Member State, the patient using the directive is perceived as a ‘consumer’ shopping around with their ‘voucher’.

To tackle this, some payers have put in place institutionalized relationships with providers in other countries. Without this or some kind of formalized arrangement between the payer and the provider in which the provider commits to comply with certain conditions and the payer assumes responsibility for the care provided, the patient will be left to defend their own interests. Within the simulation the mechanisms put in place through the directive such as national contact points and other institutions seemed unable to bridge this gap – or at least, there seemed to be much uncertainty about what they should do and how they might do it.

Given this situation it is perhaps an advantage that both patients and payers agreed that obtaining prior authorization for care before travelling was likely to become the norm, even when it is in principle not required by the directive. For patients this was in order to protect themselves against unexpected expenditure and for payers to enable them to anticipate any problems the patient might have. This is somewhat ironic, as a central element of the Court rulings which led to the Directive was precisely that such prior authorization should not be necessary.

Discussion

The simulation proved itself to be a valuable tool for highlighting some of the implementation challenges of the Directive. Certainly it uncovered some potential issues for patients while at the same time highlighting some of the practical challenges for health systems. As is so often the case with EU legislation, it also highlighted shortcomings within the health systems of Member States themselves. For example, the simulation highlighted the difficulties finding or using, or even the complete lack of reliable, independent and publicly available patient safety data. While within their own countries it can be difficult for patients to get an accurate picture of the quality of a provider or clinician, trying to do that in another country with different systems and possibly in a different language can be almost impossible.

The challenge is not just on patient safety and quality, it is also important that the patients understand the options for treatment that they have and are able to make an informed decision about the one most appropriate for them. During the simulation it was clear that the payers thought that the responsibility for ensuring that the patient was informed lay with the providers and the clinicians; however the providers thought that this was the job of the national contact point, and the national contact points thought this was something that would be picked up clinically. This risks leaving patients in the dark, making inappropriate treatment choices due to a lack of good explanation of the different treatment options open to them.

Given the size of the burden for patients, it is therefore likely that the Directive, far from heralding a new era of large flows of patients across borders, will only be used when there is really no alternative, better-managed option to receive the treatment, or by patients who may not understand the responsibility on their shoulders and the risks they take. Nevertheless, the process of implementing the Directive seems likely to have a wider impact on health systems as a whole, even if the actual number of patients using its provisions remains low.

Useful websites:

Cross Border Care – EHMA website http://www.ehma.org/index.php?q=node/608