The National Health Service (Ophthalmic Services) (Wales) Regulations 2023

Made: 27 September 2023

Laid before Senedd Cymru: 29 September 2023

Coming into force: 20 October 2023

The Welsh Ministers make the following Regulations in exercise of the powers conferred on them by sections 2, 3, 10, 12(3), 15, 71, 72, 73, 74, 76(6) and (9), 78(6), 104, 105, 106, 107(5) and (7), 110(6)(a), (9) and (10), 115(9), 116, 117, 118, 119(3), (4) and (5), 203(9) and (10), 204(3)(c)(i) and 205 of the National Health Service (Wales) Act 2006[^f00001].

PART 1 — General

Title, coming into force and application

1

• (1) The title of these Regulations is the National Health Service (Ophthalmic Services) (Wales) Regulations 2023.

• (2) These Regulations come into force on 20 October 2023.

• (3) These Regulations apply in relation to Wales.

Interpretation

2

In these Regulations—

• “the Act” (“y Ddeddf”) means the National Health Service (Wales) Act 2006;

• “combined list” (“rhestr gyfunol”) has the meaning given in regulation 10;

• “commencement date” (“dyddiad cychwyn”) means the day on which these Regulations come into force under regulation 1(2);

• “contractor” (“contractwr”) means a qualified practitioner, other than a student optometrist, who has entered into an arrangement with a Local Health Board to provide primary ophthalmic services;

• “corporate optician” (“optegydd corfforedig”) means a body corporate registered in the register maintained under section 9 of the Opticians Act 1989[^f00002] (list of bodies corporate carrying on business as opticians), which is carrying on business as an optometrist, and for the purpose of this definition, “optometrist” has the meaning given in section 36 of that Act[^f00003] (interpretation);

• “deputy” (“dirprwy”) means an ophthalmic medical practitioner or an optometrist who is included in a combined list and assists in the provision of primary ophthalmic services;

• “director” (“cyfarwyddwr”) means—a director of a body corporate;a member of a body of persons controlling a body corporate (whether or not a limited liability partnership);

• “dispensing optician” (“optegydd cyflenwi”) means a person registered as a dispensing optician in the register maintained under section 7 of the Opticians Act 1989[^f00004] (register of opticians);

• “eligible person” (“person cymwys”) has the meaning given in regulation 5;

• “employer” (“cyflogwr”) includes any partnership of which a qualified practitioner is or was a member;

• “employment” (“cyflogaeth”) means any employment whether paid or unpaid and whether under a contract of service or not, and “employee”, “employed” and “employer” must be interpreted accordingly;

• “equivalent body” (“corff cyfatebol”) means—in relation to England, NHS England, as established by section 1H of the National Health Service Act 2006[^f00005];in relation to Scotland, a Health Board established under section 2 of the National Health Service (Scotland) Act 1978[^f00006];in relation to Northern Ireland, the Department of Health in Northern Ireland;

• “equivalent list” (“rhestr gyfatebol”) means a list kept by an equivalent body which is equivalent to a primary care list;

• “eye examination” (“archwiliad llygaid”) has the meaning given in regulation 3;

• “eye examination services” (“gwasanaethau archwilio llygaid”) has the meaning given in regulation 3;

• “First-tier Tribunal” (“Tribiwnlys Haen Gyntaf”) means the First-tier Tribunal established under section 3(1) of the Tribunals, Courts and Enforcement Act 2007[^f00007] (the First-tier Tribunal);

• “general ophthalmic services” (“gwasanaethau offthalmig cyffredinol”) has the meaning given in regulation 4;

• “Health Education and Improvement Wales” (“Addysg a Gwella Iechyd Cymru”) means the body established by the Health Education and Improvement Wales (Establishment and Constitution) Order 2017[^f00008];

• “hospital” (“ysbyty”) has the meaning given in section 206 of the Act (interpretation);

• “licensing or regulatory body” (“corff trwyddedu neu reoleiddio”) means a body that licenses or regulates any profession of which the qualified practitioner is or has been a member, including a body licensing or regulating the education, training or qualifications of those professions, and any body which licenses or regulates any such profession, its education, training or qualifications, outside the United Kingdom;

• “local authority” (“awdurdod lleol”) has the meaning given in section 206 of the Act (interpretation);

• “medical” (“meddygol”) has the meaning given in section 206 of the Act (interpretation);

• “medical practitioner” (“ymarferydd meddygol”) means a fully registered person within the meaning of section 55 of the Medical Act 1983[^f00009] who holds a licence to practise under that Act;

• “mobile practice” (“practis symudol”) has the meaning given in Schedule 3;

• “mobile services” (“gwasanaethau symudol”) means primary ophthalmic services provided at a place other than a registered premises;

• “a national disqualification” (“anghymhwysiad cenedlaethol”) means—a decision made by the First-tier Tribunal under section 115 of the Act[^f00010] (national disqualification);a decision made under provisions in force in England, Scotland or Northern Ireland corresponding to section 115 of the Act;

• “the NHS Counter Fraud Authority” (“Awdurdod Gwrth-dwyll y GIG”) means the body established by the NHS Counter Fraud Authority (Establishment, Constitution, and Staff and Other Transfer Provisions) Order 2017[^f00011];

• “NHS Resolution” (“NHS Resolution”) means the NHS Litigation Authority, a body established by the National Health Service Litigation Authority (Establishment and Constitution) Order 1995[^f00012];

• “notice” (“hysbysiad”) means a notice in writing;

• “officer” (“swyddog”) has the meaning given in section 206 of the Act (interpretation);

• “ophthalmic hospital” (“ysbyty offthalmig”) includes an ophthalmic department of a hospital;

• “ophthalmic list” (“rhestr offthalmig”) has the meaning given in regulation 10;

• “ophthalmic listed appliance” (“teclyn rhestredig offthalmig”) means an appliance on the list of preparations approved by the Welsh Ministers which may be ordered by a qualifying optometrist for national health service primary ophthalmic services patients;

• “ophthalmic listed medicine” (“meddyginiaeth restredig offthalmig”) means an item on the list of preparations approved by the Welsh Ministers which may be ordered by a qualifying optometrist for national health service primary ophthalmic services patients;

• “ophthalmic medical practitioner” (“ymarferydd meddygol offthalmig”) means a person recognised under regulation 9 and Schedule 2;

• “Ophthalmic Qualifications Committee” (“Pwyllgor Cymwysterau Offthalmig”) means such committee appointed by organisations representative of the medical profession as may be recognised by the Welsh Ministers for the purposes of approving—ophthalmic hospitals, academic degrees, academic or postgraduate courses in ophthalmology and appointments affording special opportunities for acquiring the necessary skill and experience of the kind required for the provision of general ophthalmic services, andthe qualifications of medical practitioners for the purpose of general ophthalmic services;

• “optometrist” (“optometrydd”) means a person registered as an optometrist in the register maintained under section 7 of the Opticians Act 1989 (register of opticians);

• “originating events” (“digwyddiadau cychwynnol”) has the meaning given in Schedule 3;

• “patient” (“claf”) means a person for whom a contractor has agreed to provide primary ophthalmic services;

• “primary care list” (“rhestr gofal sylfaenol”) means a list referred to in section 115(1)(a) to (d) of the Act;

• “primary ophthalmic services” (“gwasanaethau offthalmig sylfaenol”) has the meaning given in regulation 4;

• “primary ophthalmic services form” (“ffurflen gwasanaethau offthalmig sylfaenol”) means a form provided by a Local Health Board which must be completed by a contractor to receive payment for providing primary ophthalmic services under these Regulations;

• “professional conduct” (“ymddygiad professiynol”) includes matters relating both to professional conduct and professional performance;

• “professional registration number” (“rhif cofrestru proffesiynol”) means the number against the qualified practitioner’s name in the relevant register maintained by the General Medical Council or the General Optical Council;

• “qualified practitioner” (“ymarferydd cymwysedig”) means—a corporate optician;an optometrist;an ophthalmic medical practitioner;a student optometrist;

• “qualifying optometrist” (“optometrydd cymhwysol”) means a person who is an optometrist included on a Local Health Board’s combined list who is providing or assisting in the provision of primary ophthalmic services in Wales;

• “the register” (“y gofrestr”) has the meaning given in Schedule 3;

• “registered premises” (“mangre gofrestredig”) means an address which is included in an ophthalmic list in relation to a contractor, in accordance with paragraph 1(g) of Schedule 3;

• “the Statement” (“y Datganiad”) has the meaning given in regulation 31;

• “student optometrist” (“myfyriwr optometreg”) means a person registered as a person undertaking training as an optometrist in the register maintained under section 8A of the Opticians Act 1989[^f00013] (register of students);

• “supplementary list” (“rhestr atodol”) has the meaning given in regulation 10;

• “suspended” (“wedi eiatal dros dro”) means suspended—under the Act;under the National Health Service Act 2006;under the National Health Service (Scotland) Act 1978;under the Health and Personal Social Services (Northern Ireland) Order 1972[^f00014];

• “terms of service” (“telerau gwasanaeth”) means the terms set out in Schedule 4.

PART 2 — Arrangements for ophthalmic services

Duty to arrange eye examinations

3

• (1) Each Local Health Board must arrange, as respects its area, for the provision of eye examinations in accordance with these Regulations.

• (2) Each Local Health Board must administer the arrangements for these services in accordance with these Regulations.

• (3) In these Regulations—

• (a) an “eye examination” means an examination of the eye for the purpose of diagnosing or determining treatment for an eye condition, or reviewing an existing condition, which includes such tests, procedures and advice as appropriate to the presenting signs, symptoms and needs of the patient, and

• (b) the services required by paragraph (1) are referred to as “eye examination services”.

General ophthalmic services and primary ophthalmic services

4

In these Regulations—

• (a) “general ophthalmic services” means the services that a contractor must provide under paragraph 23 (testing of sight) of the terms of service, and

• (b) “primary ophthalmic services” means, collectively—

• (i) general ophthalmic services, and

• (ii) eye examination services.

PART 3 — Eligibility and applications for a sight test

Eligibility for a sight test

5

A person who meets any of the criteria in paragraph 1 of Schedule 1 is eligible for a sight test under general ophthalmic services (and is referred to in these Regulations as an “eligible person”).

Application for a sight test

6

• (1) An eligible person may apply to a contractor for a sight test.

• (2) The application must—

• (a) be made on a form provided for that purpose to contractors by the relevant Local Health Board, and

• (b) contain a written declaration, signed by the applicant in writing or electronically, to the effect that they are an eligible person.

• (3) Before providing such a sight test, a contractor to whom an application has been made must—

• (a) except where paragraph (4) applies, ask the person to produce satisfactory evidence that they meet one of the criteria in paragraph 1 of Schedule 1,

• (b) where the person has been asked for, but has not provided, satisfactory evidence that they are an eligible person, record that fact on the person’s primary ophthalmic services form,

• (c) ensure that the person’s details and the approximate date of their last sight test, if any, are recorded on a primary ophthalmic services form, and

• (d) satisfy themselves that the sight test is necessary.

• (4) This paragraph applies where—

• (a) the person is eligible by reason of paragraph 1(1)(d) of Schedule 1, and

• (b) satisfactory evidence of the person’s eligibility is already available to the contractor.

• (5) Paragraph 2 of Schedule 1 makes provision about the specific evidence that a contractor must request before providing a sight test to certain persons.

• (6) The contractor—

• (a) may appoint a member of their staff to carry out the requirements of paragraph (3)(a) and (b) on their behalf, and

• (b) must ensure that the member of staff appointed for that purpose is given instruction to enable them to fulfil the requirements on behalf of the contractor.

• (7) Subject to paragraph (8), an application for general ophthalmic services under these Regulations may be made and a signature required by these Regulations may be given—

• (a) on behalf of any person under 16 years of age, by either parent, the guardian or other adult who has care of the child;

• (b) on behalf of any person under 18 years of age—

• (i) in the care of a local authority to whose care they have been committed under the Children Act 1989[^f00015] or which has received them into care under the Social Services and Well-being (Wales) Act 2014[^f00016], by a person duly authorised by that authority;

• (ii) in the care of a voluntary organisation, by that organisation or a person duly authorised by them;

• (c) on behalf of any other person who is incapable of making the application or giving the signature, by a relative or any other adult who has care of that person.

• (8) A signature on an application may not be given by the contractor to whom the application is made.

Other services treated as general ophthalmic services

7

• (1) Paragraph (5) applies where—

• (a) a person receives a sight test, other than general ophthalmic services, from a contractor,

• (b) immediately before receiving the sight test, that person was not an eligible person, and

• (c) Condition A, Condition B or Condition C is met in relation to the person.

• (2) Condition A is met in relation to the person if,

during the provision of the sight test, the person is shown to meet the eligibility criterion at paragraph 1(1)(e) of Schedule 1.

• (3) Condition B is met in relation to the person if—

• (a) before the end of a period of 14 days beginning with the day on which the sight test was provided, the person becomes an eligible person by reason of meeting the eligibility criterion in paragraph 1(1)(d) of Schedule 1 by reference to paragraph 1(2)(c), (d) or (g) of that Schedule, and

• (b) before the end of the period of 3 months beginning with the day on which the sight test was provided, the person provides to the Local Health Board a notice of entitlement to that effect.

• (4) Condition C is met in relation to the person if, before the end of the period of 3 months beginning with the day on which the sight test was provided, the person becomes an eligible person by reason of meeting the eligibility criterion in paragraph 1(1)(d) of Schedule 1 by reference to paragraph (2)(n) of that Schedule.

• (5) Where this paragraph applies the sight test must be treated as having been general ophthalmic services under the Act—

• (a) for the purposes of regulation 8(1)(a) of the National Health Service (Optical Charges and Payments) Regulations 1997[^f00017], and

• (b) for the purposes specified in section 71(8) and (9) of the Act.

• (6) Where the sight test received by a person is treated by virtue of paragraph (3) or (4) as being general ophthalmic services—

• (a) that person may provide to the Local Health Board a receipt for, or other evidence of, any fee paid for that sight test, and

• (b) if the Local Health Board is satisfied as to the amount paid for that sight test, it must pay that person an amount equal to the fee paid.

PART 4 — Combined lists

CHAPTER 1

Provision of primary ophthalmic services

8

• (1) A qualified practitioner (other than a student optometrist) may provide primary ophthalmic services in a Local Health Board’s area if they are included in that Local Health Board’s ophthalmic list (see regulation 10(2)(a)).