10.—(1) In section 6A of the NHS (Wales) Act (reimbursement of the cost of services provided in another EEA state)(1) after subsection (1) insert—
“(1A) But the duty in subsection (1) does not apply where section 6BA applies.”.
(2) After section 6B of the NHS (Wales) Act (prior authorisation for the purposes of section 6A) insert the following—
(1) This section applies where expenditure is incurred by a person on or after 25 October 2013 (but see subsections (9) and (14)).
(2) The Welsh Ministers must, on an application made by the person, reimburse to that person the amount of the qualifying EEA expenditure incurred by that person, but this is subject to subsections (8) and (9), to any limit applicable under subsection (11) and to any deduction applicable under subsection (12).
(3) For the purpose of this section, “qualifying EEA expenditure” is expenditure incurred on the provision by an authorised provider, in an EEA state other than the United Kingdom, to a person ordinarily resident in Wales (“the patient”) of a service as respects which condition A or condition B is met.
(4) Condition A is that the service—
(a)was necessary to treat or diagnose a medical condition of the patient, and
(b)is the same as or equivalent to a service that the Welsh Ministers or the Local Health Board in whose area the patient usually resides would make or have made available to the patient under this Act in the circumstances of the patient’s case.
(5) But in the case of a service which, although meeting the requirements in paragraphs (a) and (b) of subsection (4), falls within subsection (6), condition A is only met if, before the service was provided, the Welsh Ministers had given authorisation under section 6BB for the provision of the service to the patient.
(6) A service falls within this subsection if—
(a)it is subject to planning requirements relating to the objective of ensuring sufficient and permanent access to a balanced range of high quality treatment or to the wish to control costs and avoid, as far as possible, any waste of financial, technical and human resources, and—
(i)it involves a stay in hospital accommodation for at least one night, or
(ii)it requires the use of highly specialised and cost-intensive medical infrastructure or medical equipment;
(b)it involves treatments presenting a particular risk for the patient or the population, or
(c)it is provided by a healthcare provider that, on a case-by-case basis, could give rise to serious and specific concerns relating to the quality or safety of the care, with the exception of a service which is subject to European Union legislation ensuring a minimum level of safety and quality throughout the European Union.
(7) Condition B is that, before the service was provided, the Welsh Ministers had given authorisation under section 6BB(4)(b) for the provision of the service to the patient.
(8) The duty in subsection (2) does not apply where the applicant incurred the qualifying EEA expenditure in connection with an arrangement which was entered into by the applicant in the course of business and under which the applicant has gained or might be expected to gain any financial benefit.
(9) This section does not apply in circumstances where Article 20 or 27(3) of Regulation (EC) No 883/2004 applies.
(10) Subsections (11) and (12) apply where the service is the same as or equivalent to a service that the Welsh Ministers or the Local Health Board in whose area the patient usually resides would have made available to the patient under this Act in the circumstances of the patient’s case.
(11) The Welsh Ministers may limit the amount of any reimbursement under this section to the cost that the Welsh Ministers or the Local Health Board would have incurred if the same or an equivalent service had been made available by either of them.
(12) The Welsh Ministers may deduct from any reimbursement under this section the amount of any NHS charge which would have been payable for the same service or an equivalent service if the service had been made available by the Welsh Ministers or the Local Health Board; and in determining for this purpose the amount of any NHS charge regard shall be had to any entitlement the patient would have had—
(a)to any payment or contribution by virtue of regulations made under section 129(1) or (3), or
(b)to any remission or repayment by virtue of regulations made under section 130.
(13) The Welsh Ministers may determine—
(a)the form in which an application under this section must be made, and
(b)the information to be provided in support of the application.
(14) This section does not apply where expenditure is incurred in Iceland, Liechtenstein or Norway before Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare applies to those states in accordance with the EEA Agreement.
(15) In this section and section 6BB, “authorised provider”, “NHS charge” and “service” each have the meaning given in section 6A.
(1) A person may apply to the Welsh Ministers under this section for prior authorisation for the purposes of section 6BA in relation to the provision of a service (“the requested service”) to a person ordinarily resident in Wales (“the patient”).
(2) The requested service must be—
(a)a service which falls within section 6BA(6) and meets the requirements in paragraphs (a) and (b) of section 6BA(4), or
(b)a service that is neither the same as nor equivalent to a service that the Welsh Ministers or the Local Health Board in whose area the patient usually resides would make available to the patient under this Act in the circumstances of the patient’s case.
(3) The Welsh Ministers may determine—
(a)the form in which an application under this section must be made, and
(b)the information to be provided in support of the application.
(4) The Welsh Ministers—
(a)must authorise the provision of the requested service if it is a service mentioned in subsection (2)(a) (but see subsection (5)), and
(b)may authorise the provision of the requested service in any case where—
(i)the requested service is necessary to treat or diagnose a medical condition of the patient, and
(ii)the duty in paragraph (a) does not apply.
(5) The duty in subsection (4)(a) does not apply if at least one of the following conditions is met—
(a)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 requested service;
(b)the general public will be exposed with reasonable certainty to a substantial safety hazard as a result of the requested service;
(c)the requested service 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 or regulations or through accreditation systems established by the state in which the service will be provided;
(d)The Welsh Ministers or the Local Health Board can provide to the patient a service that is the same as or equivalent to the requested service within a period of time that is medically justifiable, taking into account the patient’s state of health at the time the decision under this section is made and the probable course of the medical condition to which the service relates.
(6) The matters to which the Welsh Ministers are to have regard in determining for the purpose of subsection (5)(d) whether the length of any delay is medically justifiable include—
(a)the patient’s medical history,
(b)the extent of any pain, disability, discomfort or other suffering that is attributable to the medical condition to which the service is to relate,
(c)whether any such pain, disability, discomfort or suffering makes it impossible or extremely difficult for the patient to carry out ordinary daily tasks, and
(d)the extent to which the provision of the service would be likely to alleviate, or enable the alleviation of, the pain, disability, discomfort or suffering.
(7) Any authorisation under this section must be in writing.”
Section 6A (reimbursement of the cost of services provided in another EEA state) was inserted by regulation 5 of the National Health Service (Reimbursement of the Cost of EEA Treatment) Regulations 2010 (S.I. 2010/915).