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 8 - Healthcare that may be subject to prior authorisation

12.1 Article 8 (1) allows Member States to operate a system of prior authorisation for healthcare that satisfies the criteria set out in Article 8(2). As derogation from the primary purpose of the Directive, the way in which a system of prior authorisation is operated will be interpreted by the courts. Any system of prior authorisation and decisions to grant or refuse authorisation is restricted to what is necessary and appropriate. A blanket approach cannot be adopted, nor can a system of prior authorisation be used to discriminate against patients or place obstacles in the way of their rights under the Directive.

12.2 Currently, in Scotland, patients seeking treatment in another EEA Member State should contact their GP or local NHS Board in advance of travelling to discuss whether prior authorisation is required and what levels of cost reimbursement will apply. This should happen before the patient accesses treatment in another Member State, although retrospective applications may also be considered.

12.3 Under Article 8(7) of the Directive, the NHS will have to publish clear information to patients as to which services come within the scope of prior authorisation and what the process is for applying for prior authorisation. We will advise patients in guidance to have a conversation with their local NHS health professionals before travelling for treatment.

12.4 This process of authorisation enables the patient to confirm that they are entitled to the treatment they want to receive in another part of the EEA, as well as the level of reimbursement they can expect. It also gives NHS healthcare providers the opportunity to ensure that patients are aware of all of the possible treatment options within the NHS, which may be more beneficial and convenient for the patient. However, this must not go beyond the provision of information on options - patients who insist on using their rights to seek treatment in the EEA are entitled to do so and to apply for reimbursement, subject to the conditions and limits set out in legislation.

12.5 Under existing legislation, reimbursement for certain types of specialised or cost intensive treatment or services is subject to the patient obtaining prior authorisation. And authorisation must be granted where the NHS cannot provide the treatment without undue delay.

12.6 Therefore, to ensure that the Directive provides a sustainable framework for cross-border healthcare and that Member States can manage their healthcare systems effectively and appropriately, the Scottish Government believes that prior authorisation systems are a sensible and necessary measure.

12.7 The Directive permits Member States to adopt a system of prior authorisation, which meet the conditions set out in Article 8(2), where:

(a) healthcare is made subject to 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 and:

(i) involves overnight hospital accommodation of the patient in question for at least one night; (e.g. general planned surgery) or

(ii) requires use of highly specialised and cost-intensive medical infrastructure or medical equipment; (examples here might be expensive diagnostic services, PET CT, MRI scans etc.)

(b) involves treatments presenting a particular risk for the patient or the population; (could include any treatment using e.g. radioactive isotopes) or

(c) is provided by a healthcare provider which, on a case-by-case basis, could raise serious and specific concerns relating to the quality or safety of the care with the exception of healthcare which is subject to Union legislation ensuring a minimum level of safety and quality throughout the Union (this might be where there is specific evidence from a regulator that a provider has poor outcomes in a particular procedure)

12.8 The categories of healthcare selected by the Member State must be notified to the Commission and be made publicly available. It will be necessary to have robust evidence that demonstrates the categories of healthcare satisfy the criteria. Under current domestic legislation, in sections 75B, 75C and 75D of the NHS (Scotland) Act 1978 the right to reimbursement of the cost of some healthcare, defined as "specified services" will need to be replaced to reflect the criteria set out above. The categories of healthcare to which a system of prior authorisation might apply is set out below.

Discretion to refuse prior authorisation in certain cases

12.9 Article 8(6) sets the criteria for refusal of prior authorisation for treatment requested under the terms of the Directive. Refusal of prior authorisation is only permitted in only 4 circumstances:

(a) Where the patient will, according to a clinical evaluation, be exposed with reasonable certainty to a patient-safety risk that cannot be regarded as acceptable, taking into account the potential benefit for the patient of the sought cross-border healthcare; (this could be from poor quality care or unproven procedures).

(b) Where the general public will be exposed with reasonable certainty to a substantial safety hazard as a result of the cross-border healthcare in question; (this might include where a patient who had a highly contagious disease wanted to go to another state for treatment or where a patient with mental health problems and a history of violence requested authorisation)

(c) Where this healthcare is to be provided by a healthcare provider that raises serious and specific concerns relating to the respect of standards and guidelines on quality of care and patient safety, including provisions on supervision, whether these standards and guidelines are laid down by laws and regulations or through accreditation systems established by the Member State of treatment; (this would require evidence from the appropriate regulator or authority)

(d) Where this healthcare can be provided on its territory within a time limit which is medically justifiable, taking into account the current state of health and the probable course of the illness of each person concerned.

12.10 The criteria (a), (b) and (c) above are relatively straightforward and uncontroversial, although they are really only seen as exceptional measures. For (c) in particular, it is unlikely that this could be applied as it would require health systems to have defensible evidence about a lack of robust service regulation and quality failures by a provider in order to avoid challenge.

12.11 Criterion (d) above can be summed up as "where there is no undue delay" and presents difficult issues that need to be considered carefully.

12.12 It essentially means that the cost of cross-border healthcare may be refused where the NHS is able to deliver the healthcare to the patient in a medically justified time-scale based on a clinical assessment of the individual patient's condition and not merely by reference to a general waiting time.

12.13 The European Court of Justice, in previous cases (notably in Watts - v - the UK) has said that refusal of prior authorisation is permitted where treatment can be provided within the home system in these circumstances. Some parts of the NHS could find it helpful to use this provision as a way of limiting reimbursement expenditure. However, the Directive is clear that the use of the criteria is restricted and cannot be used as an unjustified obstacle to free movement of patients. The Court of Justice has also confirmed that the unjustified use of systems of prior authorisation constitutes a barrier to freedom of movement and is contrary to European law.

12.14 Essentially, the Directive starts from the premise that the use of systems of prior authorisation should be restricted to what is necessary and proportionate. The operation of a system of prior authorisation in accordance with the Directive should be seen as a two stage process:

• to identify those categories of healthcare that we can demonstrate satisfy the criteria in Article 8(2) - i.e. subject to prior authorisation; and
• to ensure that if we adopt the discretion to refuse authorisation, where the NHS can provide equivalent treatment "without undue delay" then that discretion is operated correctly, in a proportionate manner and not in a way that undermines the purpose of the Directive.

12.15 Research commissioned by the Department of Health and conducted over 2009/10 (by the Health Economics Consortium at the University of York) concluded that many NHS healthcare providers lacked understanding and clarity about patients' rights under EU law and their entitlement to reimbursement. While knowledge in this regard has increased in recent, years, following the publication of the draft Directive and its subsequent adoption, there is still a need to educate both the Service and the public. We need to provide clarity to NHS Boards around the limits of the powers to refuse prior authorisation and what they must do when a decision to refuse is made.

12.16 The process of applying prior authorisation in individual cases would be handled by territorial NHS Boards in Scotland. When the criterion of "where there is no undue delay" was to be used to justify refusal of authorisation, it would be necessary for the decision letter to set out the reasons in full, explaining why the decision maker had concluded that the NHS could provide the treatment within a medically justified period of time. We anticipate that in using this criterion, the NHS would be expected, in each individual case, to specify in writing the medically justified period of time during which treatment must be provided based on the individual patient, and what would constitute undue delay for that patient. The ECJ has been clear that "undue delay" cannot be determined simply on the basis of general waiting time guarantees, whether national or local.

Options

12.17 This is a complex measure and we recognise that there will be legitimate interests within the NHS and beyond on how (or whether) Article 8(6)(d) should be taken forward. We therefore seek views on the issue, with three potential options as follows:

Option (i) - Adopt Article 8(6)(d) without limit

12.18 This would require clarity and consistency in the application of the procedures to ensure that the refusal was appropriate, as well as careful record keeping. There would need to be proper consideration of each case and the reasons for any refusal fully set out. Given that the criteria cannot be used as a blanket restriction on patients, we have some concerns that adoption without limit would lead to a tendency to ignore the restrictions in order to limit the number of patients seeking to access their rights in line with waiting times at home.

12.19 The Directive is intended to allow patients to access rights under EU law on the freedom to obtain services. Waiting restrictions at home for the purpose of managing resources are not the key factor for determining undue delay. Therefore, in considering whether to adopt the provision without restriction, we need to consider whether it is necessary and proportionate approach, given that there are only small numbers of patients using their rights under EU law.

12.20 If the need for a restriction is because of a sudden and growing demand from patients for particular services, the NHS could seek to use the powers available at Article 7(9). This allows, in certain circumstances, and where evidence is available, a Member State to limit access to cross-border healthcare for overriding reasons of general interest.

Option (ii) - Adopt Article 8(6)(d) but apply it to a limited list of those services requiring prior authorisation and apply certain additional caveats on the system

12.21 This option would limit application to a narrower list of services requiring authorisation, probably more specialist in nature. Applying the discretion to refuse authorisation to a more limited category of healthcare, where it is necessary to have the discretion to refuse authorisation where the NHS can provide treatment, would demonstrate that we are operating the system of prior authorisation narrowly. Taken together with carefully selected and justified categories of healthcare to which prior authorisation will apply, this would demonstrate that in adopting this system a balanced and proportionate approach was being taken. This option would limit any administrative burden on the NHS and the restrictions on an individual patient's freedom to choose to obtain healthcare in another Member State and claim a reimbursement.

12.22 As described above, the NHS would also need to set out for each patient it wished to refuse, exactly what would, from a medical standpoint, represent "undue delay" in their individual case. This would be in order to avoid patients being refused authorisation but being forced to wait longer than medically necessary for treatment at home.

12.23 The list of services subject to prior authorisation and the restrictions that apply would need to be developed and agreed, with the same safeguards applied as with option (i). In providing evidence of the proportionality of refusal, the NHS would need to do the following:

• Consider the patient's medical history;
• Consider the extent of any pain, disability, discomfort or suffering that is attributable to the medical condition to which the service relates to;
• Whether any such pain, disability, discomfort or suffering makes it impossible or extremely difficult for the patient to carry out ordinary daily tasks;
• The extent to which the provision of the service would be likely to alleviate, or enable the alleviation of pain, disability, discomfort or suffering; and
• Set out what is the medically necessary time limit within which the treatment that the patient needs should be carried out. NB - this should not be confused with waiting time guarantees or averages within the home system, which may not be appropriate in the context of the individual circumstances of the patient.

Option (iii) - Do not adopt Article 8(6)(d)

12.24 This preserves the central ethos of freedom of movement of EU citizens, which underpins this Directive and would ensure that there was limited administrative risk of the NHS imposing unreasonable restrictions, which would constitute obstacles to the freedom of movement of patients. However, by not adopting Article 8(6)(d) we would have less control on specialist and sometimes expensive services.

12.25 The Scottish Government's current thinking is that we either adopt:

Option (i) - this would require careful management, perhaps with decisions taken centrally, if it were to be operated satisfactorily, with each decision taken on the basis of the individual patient's clinical needs and in a proportionate manner, bearing in mind the overall purpose of the Directive to facilitate a patient's right to choose to obtain healthcare in another Member State; or

Option (ii) - with a limited list of services for prior authorisation and clear evidence to patients' as to why they might be refused authorisation.

However, we would welcome your views on the three options.

Consultation questions

• Do you have a view on whether or how the Scottish Government should adopt the Article 8(6)(d) derogation?
• Should the derogation (if taken) be limited to the list of services?
• Do you believe this Article can be made to work in practice?

Categories of treatments subject to prior authorisation

12.26 Where the home Member State exercises the discretion to have a system of prior authorisation, Article 8 requires that the home State must notify the European Commission of the categories of healthcare subject to prior authorisation and to make this information publicly available to citizens.

12.27 For the categories of "treatments subject to prior authorisation", Member States need to show that a convincing methodology has been used for determining this. The Commission will be reviewing those services requiring authorisation and will challenge Member States that seek to restrict the freedom of individuals to obtain services, where this is done in an arbitrary or inappropriate way. It is therefore necessary to establish a reasoned and justifiable starting position.

12.28 We take the view that prior authorisation will not be applicable generally to services such as primary care, dentistry and optometry. Equally, we do not believe that it will be reasonable to justify the application of prior authorisation to the majority of routine, planned elective care or outpatient services provided by the NHS. For example, in the case of orthopaedic or general day surgery, which are routine and form a large number of surgical procedures carried out by the NHS, we do not believe it would be possible, in the majority of cases, to demonstrate through evidence that these services meet the requirements of the criteria set out in Options (i) and (ii) above.

Specialised & High Cost Services

12.29 Although the majority of NHS services in Scotland are commissioned by NHS Boards there are different arrangements for commissioning what are called "specialised services". National Services Division (NSD) is a division within NHS National Services Scotland. Each year, NSD receives ring-fenced funding from the Scottish Government to commission and performance manage nationally designated specialist services and screening programmes.

12.30 National commissioning is reserved for those specialist services where local or even regional commissioning is not appropriate. The services are generally concerned with the diagnosis and / or treatment of rare conditions.

12.31 NSD also funds services provided in England through two distinct funding streams:

a contribution to the National Specialised Commissioning Team (NSCT) for Scottish access to designated highly specialist services which are provided on a UK basis; and

by managing a pool of funds (risk share scheme) on behalf of NHS Boards for specialised services in England which are not nationally designated.

12.32 A full list of nationally funded services is available at:

http://www.nsd.scot.nhs.uk/services/specialised/index.html.

There would seem to be some symmetry in aligning this list of specialised services with the categories for prior authorisation. However, there will be other treatments and interventions, which require significant levels of health system planning or cost-intensive medical infrastructure that may potentially need to be included in the list of categories of "treatments subject to prior authorisation". For example, complex diagnostics and imaging services (PET-CT, MRI etc), which can cost millions of pounds in capital set up costs, training and so on. We welcome views on other such services that might be included in the categories of treatments subject to prior authorisation.

Consultation questions

• Do you agree that Scotland should continue to operate a system of prior authorisation for patients requiring certain types of medical treatment or services

• In addition to specialist services and services such as diagnostics requiring considerable planning and financing, what other services might come within the scope of treatments / services that should be subject to prior authorisation?
• What is the evidence to support this?

Interaction with Directive 883/2004

12.33 Significantly, Article 8(3) states that when a patient requests prior authorisation for a relevant treatment, the home state must first of all determine whether or not the patient meets the requirements of Regulation 883/2004 (the S2 route). If they do, they should be granted authorisation under the Regulation unless the patient specifically requests to use the Directive - for example, to access the private/independent sector.

12.34 NHS Boards will need to consider the relevant aspects of both the Regulation and Directive routes. The language at Article 8(3) may need to be simplified or clarified, but this clause will need to be reflected in the implementing regulations (and underpinned by guidance).

Rare Diseases

12.35 Article 8(4) then states that if a patient is suspected of having a rare disease and applies for authorisation, the home state may carry out a clinical evaluation by experts. If there are no experts in the rare disease in question, or the expert's opinion is inconclusive, the home state may seek scientific advice of experts in another State. This clause reflects the European Parliament's and Commission's growing interest in seeking to advance the rights of citizens suffering with rare disease in particular (rare disease is defined as a prevalence of 5:10,000). However, this is discretionary and is not a binding obligation. Therefore it will not form part of the implementing legislation.