Cross Border Healthcare & Patient Mobility: Public Consultation on Scotland's Transposition and Implementation of Directive 2011/24 EU on the Application of Patients' Rights in Cross-border Healthcare.

Article 5 - Responsibilities of the Member State of affiliation

9.1 Article 5 sets out the responsibilities of the patient's home Member State under the Directive. This includes the reimbursement of the eligible costs of cross-border healthcare and ensuring that patients are provided with information about accessing cross-border healthcare services. This is about making information on rights and entitlements publicly available and easily accessible, as well as the conditions that will apply to reimbursement and procedures for appeal and redress if patients consider that their rights have not been respected.

9.2 Information about providers or services available in other Member States may also be facilitated through the respective National Contact Points. As such, Article 5 is central in making the Directive workable and relevant for EU citizens.

9.3 The Directive sets out the rights of patients in exercising personal choice to go to another EEA country to access healthcare and seek reimbursement of those costs where the treatment in question would have been made available at home to the patient in Scotland under the NHS. Importantly it is not about the NHS formally commissioning healthcare for patients in other EEA Member State. Separate rules exist to regulate this. For example when healthcare providers decide that a rare cancer should receive proton beam therapy, as this technology is not available on the NHS at this time.

9.4 In choosing to access healthcare in another Member State, the home patient is effectively stepping outside the NHS system and using their rights under EU law to seek healthcare elsewhere in the EEA.

9.5 At this point, the patient is taking individual responsibility for ensuring that the treatment they obtain is appropriate and safe within the laws of the country of treatment (not under UK or Scottish legislation). The NHS in Scotland will not be commissioning treatment or services from foreign providers under Article 5 and will not be responsible or liable in any way for the outcome of treatment provided. The implementing regulations will, however, need to impose the duties set out In Article 5 on relevant NHS bodies such as NHS Boards and the National Contact Point.

Publicising information on rights

9.6 In terms of making information on rights and entitlements publicly available, we will need to consider what communication channels we use for Scottish citizens. At the moment we package Regulation 883/2004 and the Directive together in a section on Healthcare in Europe on the Scottish Government web site at:

http://www.scotland.gov.uk/Topics/Health/Services/Europe/Healthcare-Directive

9.7 This will be revised to take account of the implementation of the Directive and to give greater emphasis on individual rights and the processes that are in place. The NCP and NHS Boards will also have a strong online presence from which information on the procedures and processes to follow can be publicised. We will also work with NHS Boards to develop approaches to reach GPs and other general medical services providers within a comprehensive information and engagement strategy to ensure that all parts of the health system in Scotland respond effectively and appropriately to patient requests.

Issues

9.8 Article 5 requires health systems to respond, on request, with appropriate clarity about an individual's entitlement to services within the home system, as well as the terms and conditions that apply for reimbursement. The expectation is that there should be easily accessible published information providing clarity and transparency on entitlements for patients in making decisions about cross-border healthcare.

Much of this information is already produced by the NHS in terms of treatment policies, criteria and thresholds for treatment. However, much of this information is not accessible to patients and needs to be made available in easily understood formats.

9.9 The Directive does not allow NHS patients to go anywhere within Europe and get any treatment (or drug) they may desire and then seek reimbursement from the NHS. Patients will only be eligible to receive reimbursement for treatments, products and services that would normally be provided by the NHS based on their clinical need.

9.10 However, the way in which European law continues to develop suggests that countries that wish to refuse reimbursement for services they do not normally provide will need to ensure that their patients are well informed as to their healthcare entitlements.

9.11 The NHS does not have a defined list of healthcare to which all patients are entitled. NHS legislation is instead premised on providing a comprehensive range of services within a universal healthcare system where local commissioners make decisions on what treatments should be prioritised for their local population, with a clear focus on commissioning for outcomes.

9.12 To avoid the risk of challenge in the future, the NHS will now need to provide patients with much greater levels of clarity as to which services the NHS does and does not in principle fund. If information on entitlements is not publicised and patients challenge the NHS on the basis that they had no means of knowing that a particular treatment method was not provided by the NHS, then it would not be possible to refuse them reimbursement in cases involving cross-border care. Therefore, to avoid uncertainty for patients, to meet transparency requirements and reduce the risk of legal challenge, healthcare providers will need to be clear to patients at the outset as to what types of healthcare they provide, or alternatively, what they do not provide.

9.13 In transposing the Directive, the Scottish Government will seek to set out the principles under which the NHS should provide clarity on entitlements to patients. There is also a need to assess the adequacy and consistency of current system requirements, and whether these leave the NHS in Scotland vulnerable to challenge on the administrative processes that patients have to go through to get information on the availability of particular treatments.

9.14 In setting out the principles under which the NHS should provide clarity on entitlements to patients in the implementing regulations, we propose placing a broad legal requirement on NHS Boards to provide information to patients on their rights and entitlements in relation to receiving cross-border healthcare. The regulatory measure would set the basic legal framework for health commissioners (NHS Boards) and detailed underpinning guidance would set out how the requirements are to be met, including:

• the information to be provided (this would need to include published information on services that are not generally available to NHS patients, including clinical and other access thresholds);
• how the information will be provided;
• the time limits by which it should be made available;
• training requirements for staff dealing with queries; and
• any other necessary directions to ensure this this function is delivered appropriately.

9.15 In the information they publish for patients, NHS Boards could also provide information about how patients can get further information including details of who to contact. However, we cannot compel patients to have further discussions with any contact point (although we could certainly recommend that they do so).

9.16 Where NHS Boards have a policy on a treatment or service, they will be required to publish at least a summary of what this means for the patient in terms of entitlement - including any clinical or other criteria used to confirm that entitlement. Where there is not a policy in place, we would not seek to require Boards to to develop new policies about services they do or do not commission. But by the same token patients cannot be made to wait for weeks while a policy is developed and agreed locally.

9.17 It is proposed that NHS Boards and / or the National Contact Point will act as contact points for patients wishing to ascertain whether or not a treatment is available and whether or not there is a policy or published information on the availability of the treatment sought. Guidance will cover what is specifically required, and we propose to ensure that, from the outset, patients can get the information they need easily without requiring NHS Boards to do more than is necessary to ensure that this is achieved.

Consultation questions

• Do you agree that this broad requirement would ensure that NHS Scotland is able to deliver the required clarity on entitlements and thereby respond appropriately to requests from patients for information on their entitlements?

• If not, what additional measures should be considered to ensure that NHS Scotland is able to deliver the required clarity on entitlements and thereby respond appropriately to patients' requests?