Clause 151: Liability of insurers

344.     Clause 151 provides that where an insurance policy covers, to any extent, a compensation payment made by an insured person in consequence of an injury, that policy will also cover any NHS costs for which the insured person is liable in respect of that injury and that this cover cannot be restricted or excluded. Subsection (4) enables regulations to be made limiting an insurer's liability in circumstances set out in the regulations. It is envisaged that this might be appropriate, for example, to enable a reduction in the NHS costs payable in cases where an insurer has only covered a proportion of the total compensation due as a result of a cap on the amount payable under the insurance policy.

Clause 152: Power to apply Part 3 to treatment at non-health service hospitals

345.     Clause 152 enables regulations to be made extending the scheme for recovery of NHS costs to cases in which treatment has been provided at a non-health service hospital under an arrangement with one of the NHS bodies listed in subsection (3)(b) and in which an injured person has been provided with ambulance services to take him to such a hospital for treatment. This would cover, for example, treatment at private or voluntary hospitals paid for by the NHS. The regulations could cover such issues as the bodies who would receive any payments recovered under the extended scheme. Subsection (2) excludes from any such extension treatment which, had it taken place at an NHS hospital, would have been private treatment or treatment under arrangements for primary dental services or general or personal medical or dental services. This mirrors the exclusions from the main scheme set out in clause 137(5).

Clause 153: The Crown

346.     This clause provides that the scheme for recovery of NHS costs will extend to the Crown (i.e.: the Queen and Government Departments) except, as a result of the definition of compensation payment in clause 137(3)(a), in circumstances where the person concerned can have no legal liability. This applies, for example, to ex-gratia payments made by or on behalf of the Queen in her personal capacity.

PART 4 - DENTAL SERVICES

347.     Part 4 is concerned with the provision of dental services in a primary care setting. Annex A to these Explanatory Notes sets out the existing law relating to the family health services (including general dental services) and personal dental services (Primary Care Act).

• First, it replaces the existing duty on PCTs to make arrangements for the provision of general dental services with a new duty to provide, or secure the provision of, primary dental services. Provision is made for general dental services contracts. Part 4 also provides for a single list of performers of primary dental services.

• Secondly, regulations may place on PCTs functions in relation to dental public health.

• Thirdly, the Dental Practice Board is abolished.

• Finally, Part 4 replaces the existing provisions in the 1977 Act about dental charges.

Clause 157: Provision of primary dental services

348.     Clause 157 inserts a new section 16CA into the 1977 Act. The new section 16CA directly confers on each PCT and LHB a duty to provide or secure the provision of primary dental services in its area to the extent that it considers reasonable to do so (16CA(1)). This new duty replaces the existing duty in section 35 of the 1977 Act (arrangements for general dental services) which requires a PCT to make arrangements with dental practitioners for the provision of dental services where a dental practitioner has agreed to provide dental treatment and appliances to a patient.

349.     Subsection (2) allows the PCT to fulfil its duty by the direct provision of dental services. This is the power that will underpin what will be known as PCT Dental Services ('PCTDS'). This will enable a PCT to employ dentists.

350.     Subsection (3) place a duty on PCTs and LHBs to publish information about the services they commission or provide. This will assist patients in identifying providers of NHS dental care in the PCT's area and the range of services offered. The duty is in response to the recommendations in Options for Change for "improving the patient experience".

351.     Subsection (4) imposes a duty on PCTs and LHBs in Wales to co-operate with other PCTs and LHBs and each other in making arrangements for primary dental services. In particular, PCTs will need to co-operate with LHBs where practices straddle the England and Wales border.

352.     Subsections (5) and (6) provide regulation making powers to define what should, or should not, be considered as primary dental services for which the PCTs and LHBs have duty to secure provision. This would allow for services in care homes, for example, to be provided not as primary dental services, but as a community health service under Part 1 of the 1977 Act.

Clause 158: Dental public health

353.     Clause 158 inserts a new section 16CB into the 1977 Act. Section 16CB gives power to confer on PCTs, LHBs and the Assembly dental public health functions. The existing duty for dental treatment and dental education in schools (section 5(1A) of the 1977) will cease to have effect under subsection (2). Functions likely to be prescribed under section 16CB(1) include school screening as well as oral health promotion and local oral health surveys to help plan services. PCTs and LHBs may involve other agencies in discharging dental public health functions, such as independent contractors or dental practices. For example, a PCT or LHB might wish to involve a dental practice in providing an oral health promotion or smoking cessation programme.

Clause 159: General dental services contracts

354.     Clause 159 inserts six new sections, 28K to 28P, into the 1977 Act.

355.     New section 28K(1) and (2) provides for a PCT or LHB to enter into a general dental services contract. A general dental services contract is a contract for primary dental services, but it may also include services which are not primary dental services, for example, specialised services such as orthodontics. The general dental service contract replaces the current statutory arrangements for the provision of general dental services as set out in the National Health Service (General Dental Services) Regulations 1992 (S.I. 1992/661). Subsection (3) of section 28K provides for PCTs and LHBs to negotiate the terms of a GDS contract with individual practices seeking to provide dental services under a GDS contract.

356.     Section 28L(1) provides regulation-making power for the Secretary of State or the Assembly to prescribe the services that must be provided under a general dental services contract. Subsection (2) would allow the services to be prescribed by reference to the manner or circumstances in which they are provided. So, for example, the regulations could provide for certain services to be provided on weekdays only between 9 am and 6pm.

357.     Section 28M provides for the PCT or LHB to enter into a GDS contract either with a dental practitioner, dental corporation ¹⁸ or a group of individuals practising in partnership. Where the contract is to be with a partnership at least one member of the partnership must be a dental practitioner. Subsection (2)(b) of new section 28M provides that where any partner is not a dental practitioner, that person must be either a health care professional as defined, an NHS employee or a person employed by a provider of PDS or PMS. This will enable persons who are not dentists to be a party to a GDS contract. Subsection (1) of new section 28M provides that regulations may place conditions on the persons who may enter into GDS contracts. It is envisaged that these regulations will disqualify certain individuals, such as those convicted of a serious offence, from holding a contract.

¹⁸ A dental corporation is a limited company permitted to carry on the business of dentistry under s40 of the Dentists Act 1984

358.     New section 28N replaces the existing system of remuneration for dentists providing general dental services under section 35 of the 1977 Act. Currently, the rules setting out the remuneration for dentists are contained in the Statement of Dental Remuneration. The SDR is a determination made by the Secretary of State or the Assembly under regulation 19 of the National Health Service (General Dental Services) Regulations 1992 (which in turn are made under section 43A and 43B of the 1977 Act).

359.     Section 28N(1) will allow the Secretary of State or Assembly to give directions regarding payments to be made under the new contract. Where directions are made, the GDS contract must require that payments are made under the contract in accordance with the directions (subsection (2)). In this way, payments in respect of any particular matter under the contract can be set on a national basis. Directions may relate to payments to be made by a PCT to a GDS provider or by a GDS provider to a PCT. Where there are no applicable directions, the parties to the GDS contract are free to determine the remuneration to be paid under the contract.

360.     Subsection (3) sets out how the power to make directions may be exercised. It will enable directions to provide for payments to be determined by reference to the meeting of particular standards for example. Directions may also be made in respect of individual practitioners and so would enable, for example, payments to be made where a dental practitioner takes maternity leave.

361.     Subsection (4) of new section 29N recreates the existing requirement in section 43B of the 1977 Act for the Secretary of State or the Assembly to consult representative bodies on remuneration matters. Under the new multi-professional GDS contract this extends consultation rights to other groups whose members can become GDS providers, for example representatives of other groups of dental health care professionals whose remuneration might also be affected.

362.     Subsection (5) provides for directions to be made by regulations or by an instrument in writing and provides where directions are made by an instrument in writing for them to be revoked or varied. Where directions are made by regulations the Interpretation Act 1889 makes equivalent provision.

363.     Subsection (6) sets out some examples of what payments under this section include, namely fees, allowances, reimbursements, loans and repayments.

364.     New section 28O(1) provides for the Secretary of State to make regulations to determine terms which the contract must include or what the contract must make provision about. Section 28O(2) gives examples of what the regulations under section 28O(1) may cover, such as, the circumstances as to the variation of contracts, details about rights of entry to, and inspection of, practice premises in connection with, for example health and safety legislation, and the dispute resolution procedure.

365.     New section 28P(1) provides for regulations concerning the resolution of pre-contract disputes to be made. In particular, the regulations may provide for the Secretary of State or the Assembly or a person appointed by him or it to determine the terms on which any GDS contract may be entered into. Section 4(4) of the National Health Service and Community Care Act 1990 makes similar provision in relation to NHS contracts to be entered into by health service bodies ¹⁹.

¹⁹ Section 4(1) of the 1990 Act defines an "NHS contract" and section 4(2) defines by way of a list "health service body".

366.     New section 28P(3) allows GDS contractors to elect to be treated as health service bodies for contracting purposes. The effect is that the contract is treated as a health service contract under section 4 of the 1990 Act, and any disputes arising under the GDS contract once it has been entered into will be determined by the Secretary of State or his appointee. Subsection (5) provides for regulations to make payments relating to NHS contracts enforceable through the courts. No GDS contractor will be forced to have health service body status (and therefore an NHS contract). If a contractor does not have the status of a health service body, then the contract is enforceable as an ordinary legal contract before the courts unless the contract itself sets out an alternative route for resolution of disputes.

367.     Subsection (4) allows regulations under subsection (3) to make provision about the effect of a change in the partnership of a GDS contractor. The purpose would be to ensure that a change in the partnership should not affect the health service body status of the contractor.

368.     Clause 159(2) provides for the repeal of sections 35 and 36 of the 1977 Act. As stated above the new GDS contract will replace the existing statutory arrangements for the provision of general dental services.

Clause 160: General dental services: transitional

369.     Subsection (1) requires the Secretary of State or the Assembly to make an Order in respect of dentists who are providing GDS under section 35 of the 1977 Act immediately prior to the coming into force of clause 159. An Order may require a PCT to enter into a new GDS contract with such a person. An Order may also require a PCT to enter into a contract for the provision of dental services. A contract under clause 160(3) may be appropriate where it has not been possible to enter into a GDS contract before the coming into force of clause 159. An Order may prescribe the circumstances in which a PCT or LHB must enter into a contract, the terms of the contract, remuneration and the resolution of any disputes.

Clause 161: Persons performing Primary Dental Services

370.     It is intended that primary dental services may only be provided to patients by persons who are considered suitable to be engaged in performing primary dental services and included on a list maintained by a PCT or LHB. New section 28Q, inserted into the 1977 Act by this clause, provides for regulations to be made to this effect and sets out how the power may be exercised. In particular, subsection (3) provides for the regulations to make provision about eligibility for inclusion in a list, grounds for refusal for inclusion in a list and the procedure to be followed. It allows provision to be made corresponding to sections 49F to 49N of the 1977 Act, thereby providing for suspension and removal from the PCT's list and appeals to the Family Health Service Appeals Authority. Further, subsection (3)(e) allows for the regulations to make provision about requirements that a person whom is included in a list must comply with if their name is to remain in the list.

371.     Section 28Q(4) and (5) allows regulations to set out the conditions that must be met before a dentist can be included in the list. The new list will replace the present dental list (section 36 of the 1977 Act), supplementary list (section 43D of the 1977 Act) and services lists in PDS (sections 8ZA of the Primary Care Act, and 28DA of the 1977 Act). Under the new arrangements a dentist who is performing primary dental services need only be on one PCT list - normally that of the PCT with who he holds a contract.

372.     Section 49M(7) of the NHS Act enables regulations to be made about payments to practitioners who have been removed from lists by primary care organisations, whose appeals to the appeals body (the Family Health Services Appeals Authority) have been unsuccessful, but have been successful on further appeal to the Courts. Subsection (2) of clause 161 provides that the regulations may also include provision for the amount of any payment or the method of calculating the amount to be determined by the Secretary of State or someone appointed by the Secretary of State.

Clause 162: Assistance and support

373.     Clause 162 inserts a new section 28R in the 1977 Act. This new section gives PCTs and LHBs a power to assist and support providers and prospective providers of primary dental services. Support and assistance includes financial support and the provision of premises on such terms as the PCT or LHB thinks fit. This will enable PCTs or LHBs, for example, to increase primary dental services capacity by giving financial assistance to establish or extend dental practice premises

374.     A PCT/LHB will be able to charge for the support given. It is expected that a charge would be made where PCT/LHB staff provide clerical functions for the practice or where a PCT/LHB dentist covered a vacancy within a practice. This is because in both these examples the practice will have received funding for those staff through the practice contract. It is not expected that a charge will be made where an additional dentist is provided on a temporary basis to help out in a crisis that might otherwise lead to a contract variation.

Clause 163: Abolition of Dental Practice Board

375.     The DPB for England and Wales is responsible for the payment of remuneration of general dental practitioners who provide general dental services under section 35 of the 1977 Act or personal dental services under a pilot scheme. Secondly, the DPB approves some higher cost proposed treatments and the fees in relation to certain general dental services and personal dental services, not specifically provided for in the Statement of Dental Remuneration, and their associated patient charges under the NHS (Dental Charges) Regulations 1989. Thirdly, it has recently been directed under section 122A of the 1977 Act to recover charges and other payments.

376.     The current structure of the DPB is inflexible in that the DPB is prevented from taking on additional NHS functions that do not relate to general dental services. In addition, the DPB is currently restricted in that the Chair and the majority of its Board members must be dental practitioners.

377.     Clause 163 provides for the abolition of the DPB. A Special Health Authority is to be established under section 11 of the 1977 Act by the Secretary of State and the Assembly. The new SHA will be a cross border SHA undertaking functions in relation to both England and Wales. The assets, liabilities and staff (subject to consultation) of the DPB will be transferred under section 11 powers to the new SHA. Until the new arrangements for contracting for GDS are brought into force, the new SHA will carry out the existing functions of the DPB. Thereafter the new SHA will undertake monitoring and quality assurance functions in relation to the new primary dental service regime.

Clause 164: Special Health Authorities

378.     Subsection (1) amends section 11 of the 1977 Act, adding a reference to the NHS (Primary Care) Act 1997. This will allow the new SHA that replaces the DPB to take on the DPB's functions in relation to PDS pilot arrangements.

379.     Subsection (2) amends section 16B of the 1977 Act in relation to the exercise of functions by PCTs. An Order may provide for the transfer to a SHA of the rights and liabilities of a PCT under a GDS contract where the SHA is to exercise functions on its behalf, and for transfer back should that function cease. Subsection (3) make similar provisions in relation to LHBs in Wales.

Clause 165: Charges for dental services

380.     The current law, section 79A of the 1977 Act, provides for the charge to be paid by a patient for dental treatment under general dental services to be based on the remuneration paid to the dentist. In particular, the existing regulations provide for the charge to be calculated on an item of service basis. The existing system may act as an incentive for the dental practitioner to maximise the items of treatment provided to a patient to maintain income.

381.     Clause 165 inserts a new section 79 and a new schedule 12ZA to the 1977 Act replacing sections 78A, 79 and 79A which make new provision in relation to dental charging.

382.     Subsection (1) of new section 79 provides for regulations to prescribe the way in which patient charges can be made and recovered for dental services. Subsection (2) provides that regulations made under subsection (1) may for example, set a maximum charge and exempt certain treatments from a charge. It is intended that dental charges will continue to bear relation to the level of service provided such as per course of treatment or per visit. Subsection (5) ensures that charges apply to all primary dental services whether provided under a GDS contract, PDS or by the PCT/LHB, and to dental appliances under other Part 1 services. Subsection (3) enables regulations made under subsection (1) to provide for the amount that PCTs, LHBs or SHAs recompense dental clinics or practices to be reduced by the amount that has been collected in patient charges by that clinic or practice.

383.     Schedule 12ZA maintains the same exemptions from dental charges as under the current provisions set out in s79 and Schedule 12 of the 1977 Act. Paragraphs 1, 2, 4 and 6 set out the circumstances in which dental charges will not apply. Paragraph 2 makes it clear that, normally, charges will not apply to the replacement or repair of appliances. Paragraph 3 provides that charges will, however, apply to the repair or replacement either of prescribed appliances, or of appliances which need to be repaired or replaced because of something that person supplied with the appliance has done (or where that person is under 16, something that their parent or guardian has done). Dental appliances will remain free of charge when provided by a hospital for its in-patients (paragraph 4). However, if dental appliances are provided for a hospital in-patient under GDS or PDS contracts or by a PCT as part of Primary Care Trust Dental Services, then the normal charges will apply (paragraph 5).

384.     Paragraph 7 enables regulations to prescribe the evidence that must be provided when a patient claims an exemption from charge. For example, a patient may be required to provide a birth certificate or FP92 Maternity Exemption Certificate issued by a PCT/LHB.

PART 5 - MISCELLANEOUS.

Clause 167: Replacement of the Welfare Food Schemes

385.     The Welfare Food Scheme was established in 1940 to protect the health of mothers and children at a time of food shortages and price rises. The scheme currently provides tokens for milk (in both liquid and dried form) and vitamins to expectant mothers and children up to the age of 5. It also provides non means-tested milk to children up to age 5 in nurseries and day care and to a very few disabled children.

386.     The consultation document, 'Healthy Start: proposals for reform of the Welfare Food Scheme' ²⁰, outlined the government's intention to set up a new scheme or schemes in 2004 with the aims of ensuring that children in low income families have access to a healthy diet and giving increased support for breastfeeding.

²⁰ For copies - postal address: PO Box 777, London SE1 6XH. Website address: www.doh.gov.uk/healthystart

387.     Clause 167 replaces section 13 of the Social Security Act 1988, which provided powers for a scheme or a number of schemes to be set up to distribute welfare food. The new section 13 provides powers for regulations to be made setting up a new scheme or schemes, better linked with health services, to help certain pregnant women, mothers and children to have access to and incorporate into their diets, food of a prescribed description.

388.     It is intended that the nutritional basis of the current scheme will be extended under the first new scheme to include a broader range of foods in addition to milk such as fruit, vegetables, cereal-based foods and other foods suitable for weaning. The aim is to use a voucher bearing a fixed value to enable beneficiaries to access these foods. It is also intended that the new scheme should be integrated with the NHS and health policies so that beneficiaries can receive appropriate advice on nutrition to accompany the prescribed food benefit.

389.     Subsection (1) supplies powers for regulations to establish one or more schemes to provide benefits for specified categories of pregnant women, mothers and children to have access to food of a prescribed description. It is intended that the new scheme, like the existing scheme, will continue to be targeted primarily at low income families in receipt of specified benefits such as Income Support, Income Based JobSeekers' Allowance and Tax Credits, and that the nursery element of the scheme will remain non means-tested.

390.     Subsection (2) obliges the Secretary of State to consult the Assembly and Scottish Ministers on the establishment or variation of a scheme. The scheme in Northern Ireland is governed by separate legislation.

391.     Subsection (3) introduces a new provision that enables requirements to be set in order that pregnant women, mothers and children can receive benefits under the scheme. Subsection (4) details some of the possible requirements that may be set, including that a beneficiary be registered to participate in the scheme, that she attend a hospital, clinic or doctor's surgery, or receive nutritional or dietary advice.

392.     The 'Healthy Start' consultation document set out a framework for registration, which included potential re-registration after the birth of a child to ensure that contact with the health service would be maximised. Such new requirements were intended to ensure that health service contact was an integral part of the scheme and that the beneficiary (or person with parental responsibility for the beneficiary) could receive advice on nutrition and matters relating to child and maternal health direct from a health professional. Provisions under subsection (4)(e) also would enable lay health workers, such as breastfeeding peer supporters, to assist in the delivery of appropriate nutrition and health advice.

393.     The current section 13 of the 1988 Act enables regulations to provide for the distribution or disposal of welfare food. Subsection (5)(a) of the new section 13 specifies on the face of the Bill the categories of providers who may supply food under the scheme. This could include food suppliers, providers of day care, and health service bodies. It is intended that retailers will supply the majority of foods in exchange for the voucher as they do presently with the current milk token and that nursery or day care institutions will provide the non-means-tested element of the scheme. Other suppliers, such as food co-operatives or voluntary and community organisations will also be encouraged to participate. As set out in the consultation document, 'Healthy Start', the government intends to shift the supply of dried milk (infant formula) to retail outlets and to end distribution via NHS clinics in order to remove a potential barrier to the promotion of breastfeeding.

394.     Subsection (5)(b) makes provision to enable beneficiaries to gain access to the prescribed food benefit by means of a voucher or other arrangement. The current scheme is based primarily upon the use of tokens that are exchangeable for specified quantities of liquid or formula milk. As it is the policy intention to provide a wider range of foods under a new scheme or schemes, different mechanisms for enabling access to the foods may be required. These may include, for example, a system based on vouchers of a fixed value which will enable parents to obtain food of a prescribed description from a wide variety of retailers.

395.     Paragraphs (d) and (e) of subsection (5) provide powers for the recompense of registered providers and the payment of beneficiaries, for example, those who fail to receive the benefit for whatever reason. These provisions, amongst other things, replace respectively subsections (4)(c) and (3)(b) of the current section 13.

396.     Paragraphs (f) and (g) of subsection (5) give the Secretary of State the power to delegate the operation of all or part of a scheme to health service or other bodies that are specified in regulations. The Department of Health, for example, may wish to contract-out elements of the scheme which relate to the distribution of vouchers to beneficiaries and reimbursement of suppliers.

397.     Subsections (5)(h) and (6) largely replace and update subsections (4)(d) and (5) of the current section 13 and provide for prescribed persons to be required to supply information to assist in the administration of the scheme. For instance, suppliers may be required to provide information to verify that vouchers have been properly exchanged in accordance with the provisions of the Scheme. Subsection (6) provides for a requirement that information be provided in legible form. Such a provision could, for example, ensure that computerised records are made available in printed form.

398.     Subsection (7) provides new powers for the Assembly to prescribe the range of foods to be available under the scheme in relation to beneficiaries in Wales and to prescribe descriptions of the advice that is provided to them. Although the existing scheme is primarily based upon social security benefits, and is therefore reserved, it is recognised that the potential range of foods and nutritional advice are issues which link closely to the devolved health policies of the Assembly. These powers have therefore been transferred to the Assembly, with agreement that the scheme will be uniform across Great Britain at the outset.

399.      It has been agreed that powers to prescribe the range of foods and descriptions of advice will also be transferred to Scottish Ministers by means of an order under section 63 of the Scotland Act 1998 after the Bill receives Royal Assent.

400.      Subsection (8) provides the power for the Secretary of State to direct a body, such as a health body or contracted service provider, in relation to the operation of the scheme. Subsection (9) provides a power for the Assembly to direct bodies administering the scheme in relation to matters relating to the operation of the scheme (or that part of the scheme) in Wales. The subsection also requires the Assembly to gain the agreement of the Secretary of State to ensure that any proposed changes will not adversely affect the operation of the scheme throughout GB, beyond the boundaries of devolved responsibilities. It is intended that this power will also be transferred to Scottish Ministers by section 63 Order after Royal Assent.

401.     Subsection (10) replaces and updates the current power in section 13(4)(e) of the 1988 Act relating to the prosecution of some offences.

402.     Subsection (11) contains, among other definitions, a definition of "enactment" which takes account of changes made by the Scotland Act 1988 to the Interpretation Act 1978.

403.     The amendment in subsection (2) of the clause to section 15A of the 1988 Act ensures that the Assembly's procedures regarding subordinate legislation are reflected in the primary legislation.