|
Navigation
News
|
 |
Statutory Instrument 2004 No. 627
The National Health Service (Personal Medical Services Agreements) Regulations 2004
(The document as of February, 2008)
-- Back --
STATUTORY INSTRUMENTS
2004 No. 627
NATIONAL HEALTH SERVICE, ENGLAND
The National Health Service (Personal Medical Services Agreements) Regulations 2004
| | Made | 8th March 2004 | | | | Laid before Parliament | 11th March 2004 | | | | Coming into force | 1st April 2004 | |
ARRANGEMENT OF REGULATIONSPART 1General
| 1. | Citation, commencement and application |
PART 2Agreements
| 3. | Conditions: introductory |
| 4. | Conditions relating solely to medical practitioners |
| 5. | General condition relating to all agreements |
PART 3Pre-agreement Dispute Resolution
PART 4Health Service Body Status
| 9. | Health service body status |
PART 5Agreements Required Terms
| 10. | Health service contract |
| 16. | Opt outs of out of hours services |
| 17. | Consequences of termination |
| 18. | Other contractual terms |
PART 6Right To A General Medical Services Contract
| 19. | Right to a general medical services contract |
PART 7Transitional Provisions
SCHEDULES
| | Schedule 1 | - Repeat Dispensing Forms |
| | Part 1 | Repeatable Prescription |
| | Schedule 2 | - List of Prescribed Medical Certificates |
| | Schedule 3 | - Fees and Charges |
| | Schedule 4 | - Opt Outs of Out of Hours Services |
| | 1 | 1.Opt outs of out of hours services where the opt out notice is served after 30th September 2004 |
| | 2 | 2.Opt outs of out of hours services where the opt out notice is served before 1st October 2004 |
| | 3 | 3.Informing patients of opt outs |
| | Schedule 5 | - Other Contractual Terms |
| | Part 1 | Provisions of services |
| | 1 | 1.Services to registered patients |
| | 3 | 3.Attendance at practice premises |
| | 4 | 4.Attendance outside practice premises |
| | 8 | 8.Criteria for out of hours services |
| | 9 | 9.Standards for out of hours services |
| | 10 | 10.Duty of co-operation |
| | 14 | 14.Application for inclusion in a list of patients |
| | 16 | 16.Refusal of applications for inclusion in the list of patients or for acceptance as a temporary resident |
| | 17 | 17.Patient preference of practitioner |
| | 18 | 18.Removal from the list at the request of the patient |
| | 19 | 19.Removals from the list at the request of the contractor |
| | 20 | 20.Removals from the list of patients who are violent |
| | 21 | 21.Removals from the list of patients registered elsewhere |
| | 22 | 22.Removals from the list of patients who have moved |
| | 24 | 24.Removals from the list of patients absent from the United Kingdom etc |
| | 25 | 25.Removals from the list of patients accepted elsewhere as temporary residents |
| | 26 | 26.Removals from a list of pupils etc of a school |
| | 27 | 27.Termination of responsibility for patients not registered with the contractor |
| | 28 | 28.Closure of lists of patients |
| | 29 | 29.Approval of closure notice |
| | 30 | 30.Rejection of closure notice |
| | 31 | 31.Assignment of patients to lists: open lists |
| | 32 | 32.Assignment of patients to lists: closed lists |
| | 33 | 33.Factors relevant to assignments |
| | 34 | 34.Assignments to closed lists: determinations of the assessment panel |
| | 35 | 35.Assignments to closed lists: NHS dispute resolution procedure relating to determinations of the assessment panel |
| | 36 | 36.Assignments to closed lists: assignments of patients |
| | Part 3 | Prescribing and dispensing |
| | 39 | 39.Repeatable prescribing services |
| | 40 | 40.Repeatable prescriptions |
| | 41 | 41.Restrictions on prescribing by medical practitioners |
| | 42 | 42.Restrictions on prescribing by supplementary prescribers |
| | 44 | 44.Excessive prescribing |
| | 45 | 45.Dispensing services: general |
| | 46 | 46.Provision of dispensing services by contractors other than Primary Care Trusts |
| | 48 | 48.Contractors who previously provided dispensing services under pilot schemes or section 28C arrangements or a general medical services contract |
| | 49 | 49.Provision of dispensing services by Primary Care Trusts |
| | 50 | 50.Terms relating to the provision of dispensing services |
| | 51 | 51.Dispensing contractor list |
| | 52 | 52.Provision of drugs, medicines and appliances for immediate treatment or personal administration |
| | Part 4 | Persons who perform services |
| | 53 | 53.Qualifications of performers |
| | 57 | 57.Conditions for employment and engagement |
| | 63 | 63.Arrangements for GP Registrars |
| | 64 | 64.Doctors with provisional registration |
| | 65 | 65.Independent nurse prescribers and supplementary prescribers |
| | 66 | 66.Signing of documents |
| | 68 | 68.Appraisal and assessment |
| | 69 | 69.Sub-contracting of clinical matters |
| | Part 5 | Records, information, notifications and rights of entry |
| | 71 | 71.Confidentiality of personal data |
| | 72 | 72.Contractor's leaflet |
| | 73 | 73.Provision of information |
| | 74 | 74.Requests for information from Patients' Forums |
| | 75 | 75.Inquiries about prescriptions and referrals |
| | 76 | 76.Reports to a medical officer |
| | 77 | 77.Annual return and review |
| | 78 | 78.Notifications to the relevant body |
| | 80 | 80.Notice provisions specific to an agreement with a qualifying body |
| | 81 | 81.Notification of deaths |
| | 82 | 82.Notifications to patients following variation of the agreement |
| | 83 | 83.Entry and inspection by the relevant body |
| | 84 | 84.Entry and inspection by members of Patients' Forums |
| | 85 | 85.Entry and inspection by the Commission for Healthcare Audit and Inspection |
| | 86 | 86.Complaints procedure |
| | 87 | 87.Making of complaints |
| | 89 | 89.Period for making complaints |
| | 90 | 90.Further requirements for complaints procedures |
| | 91 | 91.Co-operation with investigations |
| | 92 | 92.Provision of information about complaints |
| | 93 | 93.Local resolution of agreement disputes |
| | 94 | 94.Dispute resolution: non-NHS agreements |
| | 95 | 95.NHS dispute resolution procedure |
| | 96 | 96.Determination of dispute |
| | 97 | 97.Interpretation of Part 7 |
| | Part 8 | Variation and termination of agreements |
| | 98 | 98.Variation of an agreement: general |
| | 99 | 99.Termination by agreement |
| | 100 | 100.Termination by notice |
| | 101 | 101.Late payment notices |
| | 102 | 102.Termination by the relevant body: general provisions |
| | 103 | 103.Termination by the relevant body for breach of conditions in regulation 4 |
| | 104 | 104.Termination by the relevant body for the provision of untrue etc information |
| | 105 | 105.Termination by the relevant body on fitness grounds |
| | 106 | 106.Termination by the relevant body where there is a serious risk to the safety of patients or risk of financial loss to the relevant body |
| | 107 | 107.Termination by the relevant body: remedial notices and breach notices |
| | 108 | 108.Termination by the relevant body: additional provisions specific to agreements with qualifying bodies |
| | 109 | 109.Agreement sanctions |
| | 110 | 110.Agreement sanctions and the NHS dispute resolution procedure111.Termination and the NHS dispute resolution procedure |
| | 112 | 112.Clinical governance |
| | 115 | 115.Compliance with legislation and guidance |
| | 116 | 116.Third party rights |
| | Schedule 6 | - Out of Hours Transitional Provisions |
| | 1 | 1.Out of hours arrangements |
| | 2 | 2.Application for approval of an out of hours arrangement |
| | 4 | 4.Suspension of approval |
| | 5 | 5.Immediate withdrawal of approval other than following review |
| | 6 | 6.Suspension or termination of an out of hours arrangement |
| | Schedule 7 | - Modification of Patient Provisions where the Contractoris a Primary Care Trust |
| | Schedule 8 | - Closure Notice |
| | Schedule 9 | - PCTs specified for the Purposes of Repeatable Prescribing |
| | Schedule 10 | - Information to be included in a Contractor's Leaflet |
The Secretary of State for Health, in exercise of the powers conferred upon him by sections 28D, 28E and 126(4) of the National Health Service Act 1977[1], section 4(5) of the National Health Service and Community Care Act 1990[2] and of all other powers enabling him in that behalf, hereby makes the following Regulations: PART 1GENERALCitation, commencement and application 1. - (1) These Regulations may be cited as the National Health Service (Personal Medical Services Agreements) Regulations 2004 and shall come into force on 1st April 2004. (2) These Regulations apply in relation to England only[3]. Interpretation 2.In these Regulations - "the Act" means the National Health Service Act 1977; "the 1990 Act" means the National Health Service and Community Care Act 1990; "the 2003 Order" means the General and Specialist Medical Practice (Education, Training and Qualifications) Order 2003[4]; "Abolition of the Tribunal Regulations" means the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2001[5]; "Abolition of the Tribunal (Wales) Regulations" means the Abolition of the National Health Service Tribunal (Consequential Provisions) Regulations 2002[6]; "adjudicator" means the Secretary of State or a person or persons appointed by the Secretary of State under section 4(5) of the 1990 Act or paragraph 95(5) of Schedule 5; "agreement" means, except where the context otherwise requires, an agreement for primary medical services made under section 28C of the Act; "appliance" means an appliance which is included in a list for the time being approved by the Secretary of State for the purposes of section 41 of the Act; "approved medical practice" shall be construed in accordance with section 11(4) of the Medical Act 1983[7]; "armed forces GP" means a medical practitioner, who is employed on a contract of service by the Ministry of Defence, whether or not as a member of the United Kingdom Armed Forces of Her Majesty; "assessment panel" means a committee or sub-committee of a Primary Care Trust (other than the Primary Care Trust which is a party to the agreement in question) appointed to exercise functions under paragraphs 30 and 34 of Schedule 5; "bank holiday" means any day that is specified or proclaimed as a bank holiday pursuant to section 1 of the Banking and Financial Dealings Act 1971[8]; "batch issue" means a form provided by a Primary Care Trust and issued by a prescriber at the same time as a repeatable prescription to enable a chemist to receive payment for the provision of repeat dispensing services which is in the format specified in Part 2 of Schedule 1, and which - (a) is generated by a computer and not signed by a prescriber,
(b) relates to a particular repeatable prescription and contains the same dates as that prescription,
(c) is issued as one of a sequence of forms, the number of which is equal to the number of occasions on which the drugs, medicines or appliances ordered on the repeatable prescription may be provided, and
(d) specifies a number denoting its place in the sequence referred to in paragraph (c);
"CCT" means Certificate of Completion of Training awarded under article 8 of the 2003 Order, including any such certificate awarded in pursuance of the competent authority functions of the Postgraduate Medical Education and Training Board specified in article 20(3)(a) of that Order; "charity trustee" means one of the persons having the general control and management of the administration of a charity; (a) a registered pharmacist,
(b) a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968[9], or
(c) a supplier of appliances,
who is included in the list of a Primary Care Trust or a Local Health Board under section 42 of the Act, or who provides local pharmaceutical services in accordance with LPS arrangements;
"child" means a person who has not attained the age of 16 years; "closed", in relation to the contractor's list of patients, means closed to applications for inclusion in the list of patients other than from immediate family members of registered patients; "contractor" means, except where the context otherwise requires - (a) where a Primary Care Trust is not providing services under the agreement, a person or persons other than a Primary Care Trust, who is a party, or are parties, to the agreement, or
(b) where a Primary Care Trust is providing services under the agreement, that Primary Care Trust and any other person or persons (other than a Strategic Health Authority) who is a party, or are parties, to the agreement;
"contractor's leaflet" means a leaflet drawn up in accordance with paragraph 72 of Schedule 5; "contractor's list of patients" means the list prepared and maintained by the Primary Care Trust under paragraph 13 of Schedule 5 and references to the contractor having a list of patients shall be interpreted accordingly; "contractor's practice area" means the area specified in the agreement as the area in which essential services are to be provided; "contractor's premises" means an address specified in the agreement as one at which services are to be provided under the agreement; "core hours" means the period beginning at 8am and ending at 6.30pm on any day from Monday to Friday except Good Friday, Christmas Day or bank holidays; "dispensing services" means the provision of drugs, medicines or appliances that may be provided as pharmaceutical services by a medical practitioner in accordance with arrangements made under regulation 20 of the Pharmaceutical Regulations; "Drug Tariff" has the same meaning as in regulation 18 of the Pharmaceutical Regulations; "essential services" means the services described in regulation 15(3), (5), (6) and (8) of the General Medical Services Contracts Regulations; "FHSAA" means the Family Health Service Appeal Authority constituted under section 49S of the Act[10]; "FHSAA (SHA)" means the Family Health Services Appeal Authority (Special Health Authority) established by article 2 of the Family Health Services Appeal Authority (Establishment and Constitution) Order 1995[11]; "general medical practitioner" means, except where the context otherwise requires - (a) on or after the coming into force of article 10 of the 2003 Order, a medical practitioner whose name is included in the General Practitioner Register, and
(b) before the coming into force of that article, a medical practitioner who is either -
(i) until the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, suitably experienced within the meaning of section 31(2) of the Act, section 21 of the National Health Service (Scotland) Act 1978[12] or Article 8(2) of the Health and Personal Social Services (Northern Ireland) Order 1978[13], or has an acquired right to practise as a general medical practitioner pursuant to regulation 5(1)(d) of the Vocational Training for General Medical Practice (European Requirements) Regulations 1994[14], or
(ii) upon the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, an eligible general practitioner pursuant to that paragraph;
"General Medical Services Contracts Regulations" means the National Health Services (General Medical Services Contracts) Regulations 2004[15]; "General Practitioner Register" means the register kept by the General Medical Council under article 10 of the 2003 Order; (a) until the coming into force of article 5 of the 2003 Order, means a medical practitioner who is being trained in general practice by a medical practitioner who -
(i) has been approved for that purpose by the Joint Committee on Postgraduate Training for General Practice under regulation 7 of the National Health Service (Vocational Training for General Medical Practice) Regulations 1997[16], and
(ii) performs primary medical services, and
(b) from the coming into force of that article, means a medical practitioner who is being trained in general practice by a GP Trainer whether as part of training leading to the award of a CCT or otherwise;
"GP Trainer" means a general medical practitioner who is - (a) until the coming into force of article 4(5)(d) of the 2003 Order, approved as a GP Trainer by the Joint Committee on Postgraduate Training for General Practice under regulation 7 of the National Health Service (Vocational Training for General Medical Practice) Regulations 1997, or
(b) from the coming into force of that article, approved by the Postgraduate Medical Education and Training Board under article 4(5)(d) of the 2003 Order for the purposes of providing training to a GP Registrar under article 5(1)(c)(i);
"Health and Social Services Board" means a Health and Social Services Board established under the Health and Personal Social Services (Northern Ireland) Order 1972[17]; "Health and Social Services Trust" means a Health and Social Services Trust established under the Health and Personal Social Services (Northern Ireland) Order 1991[18]; "Health Board" means a Health Board established under the National Health Service (Scotland) Act 1978; "health care professional" has the same meaning as in section 28M of the Act (persons eligible to enter into GDS contracts)[19] and "health care profession" shall be construed accordingly; "health service body" has, unless the context otherwise requires, the meaning given to it in section 4(2) of the 1990 Act[20]; "immediate family member" means - (a) a spouse,
(b) a person (whether or not of the opposite sex) whose relationship with the registered patient has the characteristics of the relationship between husband and wife,
(c) a parent or step parent,
(d) a son,
(e) a daughter,
(f) a child of whom the registered patient is -
(i) the guardian, or
(ii) the carer duly authorised by a local authority to whose care the child has been committed under the Children Act 1989[21], or
(g) a grandparent;
"independent nurse prescriber" means a person - (a) who is either engaged or employed by the contractor or is a party to the agreement,
(b) who is registered in the Nursing and Midwifery Register, and
(c) in respect of whom there is an annotation signifying that he is qualified to order drugs, medicines and appliances from -
(i) the Nurse Prescribers' Formulary for District Nurses and Health Visitors in Part XVIIB(i) of the Drug Tariff, or
(ii) the Nurse Prescribers' Extended Formulary in Part XVIIB(ii) of the Drug Tariff;
"licensing authority" shall be construed in accordance with section 6(3) of the Medicines Act 1968[22]; "licensing body" means any body that licenses or regulates any profession; "Local Medical Committee" means a committee recognised under section 45A of the Act[23]; "local pharmaceutical services" has the same meaning as in regulation 2 of the National Health Service (Local Pharmaceutical Services and Pharmaceutical Services) Regulations 2002[24]; "medical card" means a card issued by a Primary Care Trust, Local Health Board, Health Authority, Health Board or Health and Social Services Board to a person for the purpose of enabling him to obtain, or establishing his title to receive, primary medical services; "medical officer" means a medical practitioner who is - (a) employed or engaged by the Department for Work and Pensions, or
(b) provided by an organisation in pursuance of an agreement entered into with the Secretary of State for Work and Pensions;
"medical performers list" means a list of medical practitioners prepared and published by a Primary Care Trust pursuant to regulation 3(1) of the National Health Service (Performers Lists) Regulations 2004[25]; "Medical Register" means the registers kept under section 2 of the Medical Act 1983[26]; "NCAA" means the National Clinical Assessment Authority established as a Special Health Authority under section 11 of the Act; "national disqualification" means - (a) a decision made by the FHSAA under section 49N of the Act (national disqualification)[27],
(b) a decision under provisions in force in Scotland or Northern Ireland corresponding to section 49N of the Act, or
(c) a decision by the NHS Tribunal which is treated as a national disqualification by the FHSAA by virtue of regulation 6(4)(b) of the Abolition of the Tribunal Regulations or regulation 6(4)(b) of the Abolition of the Tribunal (Wales) Regulations;
"NHS trust" in relation to Scotland means a NHS trust established under the National Health Service (Scotland) Act 1978; "NHS contract" has the meaning assigned to it in section 4 of the 1990 Act; "the NHS dispute resolution procedure" means the procedure for resolution of disputes specified - (a) in paragraphs 95 and 96 of Schedule 5, or
(b) in a case to which paragraph 35 of Schedule 5 applies, in that paragraph;
"the NHS Tribunal" means the Tribunal constituted under section 46 of the Act[28] for England and Wales, and which, except for prescribed cases, had effect in relation to England only until 14th December 2001 and in relation to Wales only until 26th August 2002[29]; "normal hours" means, except in Schedule 6, those days and hours on which and the times at which services under the agreement are normally made available and may be different for different services; "Nursing and Midwifery Register" means the register maintained by the Nursing and Midwifery Council under the Nursing and Midwifery Order 2001[30]; "open", in relation to a contractor's list of patients, means open to applications from patients in accordance with paragraph 14 of Schedule 5; "out of hours period" means - (a) the period beginning at 6.30pm on any day from Monday to Thursday and ending at 8am on the following day,
(b) the period between 6.30pm on Friday and 8am on the following Monday, and
(c) Good Friday, Christmas Day and bank holidays,
and "part" of an out of hours period means any part of any one or more of the periods described in paragraphs (a) to (c);
"out of hours services" means services required to be provided in all or part of the out of hours period which would be essential services if provided in core hours; "parent" includes, in relation to any child, any adult who, in the opinion of the contractor, is for the time being discharging in respect of that child the obligations normally attaching to a parent in respect of his child; (a) a registered patient,
(b) a temporary resident,
(c) persons to whom the contractor is required to provide immediately necessary treatment as part of its obligation to provide essential services, and
(d) any other person to whom the contractor has agreed to provide services under the agreement;
"Patients' Forum" means a Patients' Forum established for a Primary Care Trust under section 15 of the National Health Service Reform and Health Care Professions Act 2002[31]; "Pharmaceutical Regulations" means the National Health Service (Pharmaceutical Services) Regulations 1992[32]; "the POM Order" means the Prescription Only Medicines (Human Use) Order 1997[33]; (a) a medical practitioner,
(b) an independent nurse prescriber, and
(c) a supplementary prescriber,
who is either engaged or employed by the contractor or is a party to the agreement;
"prescription form" means a form provided by the Primary Care Trust and issued by a prescriber to enable a person to obtain pharmaceutical services or local pharmaceutical services and does not include a repeatable prescription; "prescription only medicine" means a medicine referred to in article 3 of the POM Order (medicinal products on prescription only); "primary care list" means - (a) a list of persons performing primary medical or dental services prepared in accordance with regulations made under section 28X of the Act (persons performing primary medical and dental services)[34],
(b) a list of persons undertaking to provide general medical services, general dental services, general ophthalmic services or, as the case may be, pharmaceutical services prepared in accordance with regulations made under sections 29 (arrangements and regulations for general medical services), 36 (arrangements for general dental services), 39 (regulations as to section 38), 42 (regulations as to pharmaceutical services) or 43 (persons authorised to provide pharmaceutical services) of the Act,
(c) a list of persons approved for the purposes of assisting in the provision of any such services mentioned in paragraph (b) prepared in accordance with regulations made under section 43D of the Act (supplementary lists)[35],
(d) a services list referred to in section 8ZA of the National Health Service (Primary Care) Act 1997 (lists of persons who may perform personal medical services or personal dental services)[36],
(e) a list corresponding to a services list prepared by virtue of regulations made under section 41 of the Health and Social Care Act 2001 (corresponding provision and application of enactments)[37], or
(f) a list corresponding to any of the above lists in Scotland or Northern Ireland;
"Primary Care Trust" means, except where the context otherwise requires, the Primary Care Trust which is a party, or prospective party, to an agreement; "primary carer" means, in relation to an adult, the adult or organisation primarily caring for him; "registered patient" means - (a) a person who is recorded by the Primary Care Trust pursuant to paragraph 13 of Schedule 5 as being on the contractor's list of patients or its list of patients, or
(b) a person whom the contractor has accepted for inclusion on its list of patients, whether or not, in the case of a contractor which is not a Primary Care Trust, notification of that acceptance has been received by the Primary Care Trust and who has not been notified by the Primary Care Trust as having ceased to be on that list;
(a) in a case where a contractor is a party to an agreement with a Primary Care Trust, that Primary Care Trust, and
(b) in a case where a contractor is a party to an agreement with a Strategic Health Authority, that Strategic Health Authority;
"relevant register" means - (a) in relation to a nurse, the Nursing and Midwifery Register, and
(b) in relation to a pharmacist, the register maintained in pursuance of section 2(1) of the Pharmacy Act 1954 (the registers and registration)[38] or the register maintained in pursuance of articles 6 (the registers) and 9 (the registrar) of the Pharmacy (Northern Ireland) Order 1976[39];
"relevant Strategic Health Authority" means the Strategic Health Authority established for an area which includes the area for which the Primary Care Trust is established; "repeat dispensing services" means pharmaceutical services or local pharmaceutical services which involve the provision of drugs, medicines or appliances by a chemist in accordance with a repeatable prescription; "repeatable prescribing services" means services which involve the prescribing of drugs, medicines or appliances on a repeatable prescription; "repeatable prescription" means a prescription contained in a form provided by a Primary Care Trust and issued by a prescriber to enable a person to obtain pharmaceutical services or local pharmaceutical services, which is in the format specified in Part 1 of Schedule 1 and which - (a) is generated by a computer but signed by a prescriber, and
(b) indicates that the drugs, medicines or appliances ordered on that form may be provided more than once and specifies the number of occasions on which they may be provided;
"restricted availability appliance" means an appliance which is approved for particular categories of persons or particular purposes only; (a) a drug, medicine or other substance specified in any directions given by the Secretary of State under section 28U of the Act (GMS contracts: prescription of drugs etc)[40] as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under a general medical services contract, or
(b) except where the conditions in paragraph 41(2) of Schedule 5 are satisfied, a drug, medicine or other substance which is specified in any directions given by the Secretary of State under section 28U of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes;
"Strategic Health Authority" means, except where the context otherwise requires, the Strategic Health Authority which is a party, or prospective party, to an agreement; "supplementary prescriber" means a person - (a) who is either engaged or employed by the contractor or is a party to the agreement,
(b) whose name is registered in -
(i) the Nursing and Midwifery Register,
(ii) the Register of Pharmaceutical Chemists maintained in pursuance of section 2(1) of the Pharmacy Act 1954, or
(iii) the register maintained in pursuance of Articles 6 and 9 of the Pharmacy (Northern Ireland) Order 1976, and
(c) against whose name is recorded in the relevant register an annotation signifying that he is qualified to order drugs, medicines and appliances as a supplementary prescriber;
"temporary resident" means a person accepted by the contractor as a temporary resident under paragraph 15 of Schedule 5 and for whom the contractor's responsibility has not been terminated in accordance with that paragraph; "walk-in centre" means a centre at which information and treatment for minor conditions is provided to the public under arrangements made by or on behalf of the Secretary of State; "working day" means any day apart from Saturday, Sunday, Christmas Day, Good Friday or a bank holiday; and "writing", except in paragraph 98(1) of Schedule 5 and unless the context otherwise requires, includes electronic mail and "written" should be construed accordingly. (2) In these Regulations, the use of the term "it" in relation to a contractor shall be deemed to include a reference to a contractor which is an individual or two or more persons contracting together to provide services under an agreement and related expressions shall be construed accordingly.
PART 2AGREEMENTSConditions: introductory 3.A relevant body may make an agreement only if the conditions set out in regulations 4 and 5 are met. Conditions relating solely to medical practitioners 4. - (1) A relevant body may make an agreement with a medical practitioner (whether he falls within section 28D(1)(b) or another paragraph of section 28D(1)), only if he - (a) is a general medical practitioner; or
(b) is employed by a Primary Care Trust, a Local Health Board, (in England and Wales and Scotland) an NHS Trust, an NHS foundation trust, (in Scotland) a Health Board or (in Northern Ireland) a Health and Social Services Trust.
(2) A relevant body may make an agreement with a qualifying body only if any share or shares in the qualifying body are legally and beneficially owned by a medical practitioner who is -
(a) a general medical practitioner; or
(b) a medical practitioner who is employed by a Primary Care Trust, a Local Health Board, (in England and Wales and Scotland) an NHS Trust, an NHS foundation trust, (in Scotland) a Health Board or (in Northern Ireland) a Health and Social Services Trust.
(3) In paragraph (1)(a) and (2)(a) "general medical practitioner" does not include -
(a) from the coming into force of article 10 of the 2003 Order, a medical practitioner whose name is included in the General Practitioner Register by virtue of paragraph 1(d) of Schedule 6 to that Order; and
(b) until the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, a medical practitioner who either -
(i) has an acquired right to practise as a general medical practitioner pursuant to regulation 5(1)(d) of the Vocational Training for General Medical Practice (European Requirements) Regulations 1994[41], or
(ii) upon the coming into force of paragraph 22 of Schedule 8 to the 2003 Order, is an eligible general practitioner pursuant to that paragraph by virtue of an acquired right under paragraph 1(d) of Schedule 6 to the 2003 Order.
General condition relating to all agreements
5. - (1) A relevant body may make an agreement with an individual falling within section 28D(1)(b) to (d) only if that individual does not fall within paragraph (3).
(2) A relevant body may make an agreement with a qualifying body only if -
(a) the qualifying body;
(b) any person legally and beneficially owning a share in the qualifying body; and
(c) any director or secretary of the qualifying body,
does not fall within paragraph (3).
(3) A person falls within this paragraph if -
(a) he or it (in the case of a qualifying body), is the subject of a national disqualification;
(b) subject to paragraph (4), he or it is disqualified or suspended (other than by an interim suspension order or direction pending an investigation) from practising by any licensing body anywhere in the world;
(c) within the period of five years prior to the signing of the agreement or commencement of the agreement, whichever is the earlier, he has been dismissed (otherwise than by reason of redundancy) from any employment by a health service body unless he has subsequently been employed by that health service body or another health service body and paragraph (5) applies to him or that dismissal was the subject of a finding of unfair dismissal by any competent tribunal or court;
(d) within the period of five years prior to signing the agreement or commencement of the agreement, whichever is the earlier, he or it has been removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 49F(2), (3) and (4) of the Act respectively[42]) unless his name has subsequently been included in such a list;
(e) he has been convicted in the United Kingdom of murder;
(f) he has been convicted in the United Kingdom of a criminal offence, committed on or after 1st April 2002, and has been sentenced to a term of imprisonment of over six months;
(g) subject to paragraph (6) he has been convicted elsewhere of an offence -
(i) which would, if committed in England and Wales, constitute murder,
(ii) committed on or after 3rd November 2003 which would, if committed in England and Wales, constitute a criminal offence other than murder, and been sentenced to a term of imprisonment of over six months;
(h) he has been convicted of an offence referred to in Schedule 1 to the Children and Young Persons Act 1933 (offences against children and young persons with respect to which special provisions of the Act apply)[43] or Schedule 1 to the Criminal Procedure (Scotland) Act 1995 (offences against children under the age of 17 years to which special provisions apply)[44] committed on or after 1st April 2004;
(i) he or it has -
(i) been adjudged bankrupt or had sequestration of his estate awarded unless (in either case) he has been discharged or the bankruptcy order has been annulled,
(ii) been made the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A to the Insolvency Act 1986[45],
(iii) made a composition or arrangement with, or granted a trust deed for, his or its creditors unless he or it has been discharged in respect of it, or
(iv) an administrator, administrative receiver or receiver appointed in respect of it;
(j) he has been -
(i) removed from the office of charity trustee or trustee for a charity by an order made by the Charity Commissioners or the High Court on the grounds of any misconduct or mismanagement in the administration of the charity for which he was responsible or to which he was privy, or which he by his conduct contributed to or facilitated, or
(ii) removed under section 7 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990 (powers of the Court of Session to deal with management of charities)[46], from being concerned in the management or control of any body; or
(k) he is subject to a disqualification order under the Company Directors Disqualification Act 1986[47], the Companies (Northern Ireland) Order 1986[48] or to an order made under section 429(2)(b) of the Insolvency Act 1986 (failure to pay under county court administration order)[49].
(4) A person shall not fall within paragraph (3)(b) where the relevant body is satisfied that the disqualification or suspension from practising is imposed by a licensing body outside the United Kingdom and it does not make the person unsuitable to be -
(a) a party to an agreement; or
(b) in the case of an agreement with a qualifying body -
(i) a person legally and beneficially owning a share in the qualifying body, or
(ii) a director or secretary of the qualifying body,
as the case may be.
(5) Where a person has been employed as a member of a health care profession any subsequent employment must also be as a member of that profession.
(6) A person shall not fall within paragraph (3)(g) where the relevant body is satisfied that the conviction does not make the person unsuitable to be -
(a) a party to an agreement;
(b) in the case of an agreement with a qualifying body -
(i) a person legally and beneficially owning a share in the qualifying body, or
(ii) a director or secretary of the qualifying body,
as the case may be.
Reasons
6. - (1) Where a relevant body is of the view that the conditions in regulation 4 or 5 for making an agreement are not met it shall notify in writing the person or persons intending to make the agreement of its view and the reasons for that view and of his, its or their right of appeal under regulation 7.
(2) The relevant body shall also notify in writing of its view and the reasons for that view any person legally and beneficially owning a share in, or a director or secretary of, a qualifying body that is notified under paragraph (1) where its reason for the decision relates to that person or those persons.
Appeal
7.A person who has been served with a notice under regulation 6(1) may appeal to the FHSAA against the decision of the relevant body that the conditions in regulation 4 or 5 are not met by giving notice in writing to the FHSAA within the period of 28 days beginning on the day that the relevant body served its notice.
PART 3PRE-AGREEMENT DISPUTE RESOLUTIONPre-agreement disputes 8. - (1) Except where both parties to the prospective agreement are health service bodies (in which case section 4(4) of the 1990 Act applies), if, in the course of negotiations intending to lead to an agreement, the prospective parties to that agreement are unable to agree on a particular term of the agreement, either party may refer the dispute to the Secretary of State to consider and determine the matter. (2) Disputes referred to the Secretary of State in accordance with paragraph (1) or section 4(4) of the 1990 Act shall be considered and determined in accordance with the provisions of paragraphs 95(3) to (14) and 96(1) of Schedule 5, and paragraph (3) (where it applies) of this regulation. (3) In the case of a dispute referred to the Secretary of State under paragraph (1), the determination - (a) may specify terms to be included in the proposed agreement;
(b) may require the relevant body to proceed with the proposed agreement, but may not require the proposed contractor to proceed with the proposed agreement; and
(c) shall be binding upon the prospective parties to the agreement.
PART 4HEALTH SERVICE BODY STATUSHealth service body status 9. - (1) A contractor shall be regarded as a health service body for the purposes of section 4 of the 1990 Act from the date that it makes an agreement unless - (a) in the case of an agreement with a single individual or qualifying body, that individual or body; or
(b) in the case of any other agreement, any of the proposed parties to the agreement (other than the relevant body),
objects in a written notice served on the relevant body at any time prior to the agreement being made.
(2) Where a contractor is to be regarded as a health service body for the purposes of section 4 of the 1990 Act pursuant to paragraph (1), any change in the parties comprising the contractor shall not affect the health service body status of the contractor.
(3) If, pursuant to paragraph (1) or (4) a contractor is to be regarded as a health service body, that fact shall not affect the nature of, or any rights or liabilities arising under, any other agreement or contract with a health service body entered into by that contractor before the date on which the contractor is to be so regarded.
(4) A contractor may at any time request a variation of the agreement to include provision or remove provision from the agreement that the agreement is an NHS contract, and if it does so -
(a) the relevant body shall agree to the variation; and
(b) the procedure in paragraph 98(1) of Schedule 5 shall apply.
(5) If, pursuant to paragraph (4), the relevant body agrees to the variation of the agreement so as to remove provision from the agreement that the agreement is an NHS contract, the contractor shall, subject to paragraph (7), cease to be regarded as a health service body for the purposes of section 4 of the 1990 Act from the date that variation is to take effect.
(6) If, pursuant to paragraph (4), the relevant body agrees to the variation of the agreement so as to include a provision in the agreement that the agreement is an NHS contract, the contractor shall be regarded as a health service body for the purposes of section 4 of the 1990 Act from the date that the variation takes effect.
(7) Subject to paragraph (8), a party or parties who were to be regarded as a health service body pursuant to paragraph (1) or (4), as the case may be, shall cease to be a health service body for the purposes of section 4 of the 1990 Act if the agreement terminates.
(8) Where a contractor ceases to be a health service body pursuant to -
PART 5AGREEMENTS: REQUIRED TERMSHealth service contract 10.If the contractor is to be regarded as a health service body, the agreement must state that the agreement is an NHS contract. Agreements: general 11. - (1) An agreement must specify - (a) the services to be provided;
(b) subject to paragraph (2), the address of each of the premises to be used by the contractor or any sub-contractor for the provision of such services;
(c) to whom such services are to be provided;
(d) where the agreement requires the contractor to provide essential services, the area as respects which persons resident in it will, subject to any other terms of the agreement relating to patient registration, be entitled to -
(i) register with the contractor, or
(ii) seek acceptance by the contractor as a temporary resident; and
(e) subject to paragraph (4), where the agreement requires the contractor to provide essential services, whether, at the date on which the agreement comes into force, the contractor's list of patients is open or closed.
(2) The premises referred to in paragraph (1)(b) do not include -
(a) the homes of patients; or
(b) any other premises where services are provided on an emergency basis.
(3) Where, in accordance with paragraph (1)(e), the agreement specifies that the contractor's list of patients is closed, it must also specify in relation to that closure each of the items listed in paragraph 28(8)(a) to (d) of Schedule 5.
(4) Where the contractor is a Primary Care Trust, the agreement must specify that its list of patients is open.
Certificates
12. - (1) An agreement which requires the contractor to provide essential services must contain a term which has the effect of requiring the contractor to issue free of charge to a patient or his personal representatives any medical certificate of a description prescribed in column 1 of Schedule 2, which is reasonably required under or for the purposes of the enactments specified in relation to the certificate in column 2 of that Schedule, except where, for the condition to which the certificate relates, the patient -
(2) The exception in paragraph (1)(a) shall not apply where the certificate is issued pursuant to regulation 2(1)(b) of the Social Security (Medical Evidence) Regulations 1976 (which provides for the issue of a certificate in the form of a special statement by a doctor on the basis of a written report made by another doctor)[50].
Finance
13. - (1) Subject to paragraph (2), the agreement must contain a term which has the effect of requiring the relevant body to make payments to the contractor under the agreement promptly and in accordance with both the terms of the agreement and any other terms based on which the payment is made and any other conditions relating to the payment contained in directions given by the Secretary of State under section 17 (Secretary of State's directions: exercise of functions) or 28E(3A) of the Act[51].
(2) The obligation referred to in paragraph (1) is subject to any right the relevant body may have to set off against any amount payable to the contractor under the agreement any amount -
(a) that is owed by the contractor to the relevant body under the agreement; or
(b) that the relevant body may withhold from the contractor in accordance with the terms of the agreement or any other applicable provisions contained in directions given by the Secretary of State under section 17 or 28E(3A).
14.The agreement must contain a term to the effect that where, pursuant to directions under section 17 or 28E(3A), a relevant body is required to make a payment to a contractor under an agreement but subject to conditions, those conditions are to be a term of the agreement.
Fees and charges
15. - (1) The agreement must contain terms relating to fees and charges which have the same effect as those set out in paragraphs (2) to (4).
(2) The contractor shall not, either itself or through any other person, demand or accept from any patient of its a fee or other remuneration, for its own or another's benefit, for -
(a) the provision of any treatment whether under the agreement or otherwise; or
(b) any prescription or repeatable prescription for any drug or appliance,
except in the circumstances set out in Schedule 3.
(3) Where a person applies to a contractor for the provision of services and claims to be entitled to be treated by the contractor without paying a fee or other remuneration, and the contractor has reasonable doubts about that person's claim, the contractor shall give any necessary treatment and shall be entitled to demand and accept a reasonable fee accordingly in accordance with paragraph (e) of Schedule 3, subject to the provision for repayment contained in paragraph (4).
(4) Where a person from whom a contractor received a fee under paragraph (e) of Schedule 3 applies to the relevant body for a refund within 14 days of payment of the fee (or such longer period not exceeding a month as the relevant body may allow if it is satisfied that the failure to apply within 14 days was reasonable) and the relevant body is satisfied that the person was entitled to be treated by the contractor without paying a fee or other remuneration when the treatment was given, the relevant body may recover the amount of the fee from the contractor, by set off or otherwise, and shall pay that amount to the person who paid the fee.
Opt outs of out of hours services
16. - (1) Where -
(a) an agreement which is made before 1st October 2004 with a contractor (other than a Primary Care Trust) requires the contractor to provide out of hours services pursuant to regulation 20; and
(b) the contractor has contracted to provide out of hours services only to patients which it is required to provide essential services to under the agreement,
the agreement must contain terms relating to the procedure for opting out of those services which have the same effect as those specified in paragraphs 1 to 3 of Schedule 4 except paragraph 1(15) to (17) and paragraph 2(17) in so far as that sub-paragraph relates to paragraph 1(15) to (17).
(2) Where -
(a) an agreement which is made on or after 1st October 2004 with a contractor (other than a Primary Care Trust) requires the contractor to provide out of hours services pursuant to regulation 20; and
(b) the contractor has contracted to provide out of hours services only to patients which it is required to provide essential services to under the agreement,
the agreement must contain terms relating to the procedure for opting out of those services which have the same effect as those specified in paragraphs 1 and 3 of Schedule 4 except paragraph 1(15) to (17) of that Schedule.
(3) Paragraph 1(15) to (17) and paragraph 2(17) in so far as that sub-paragraph relates to paragraph 1(15) to (17) of Schedule 4 shall have effect in relation to the matters set out in those paragraphs.
Consequences of termination
17.An agreement shall make suitable provision for arrangements on termination of an agreement, including the consequences (whether financial or otherwise) of the agreement ending, subject to any specific requirements in these Regulations.
Other contractual terms
18. - (1) An agreement must, unless it is of a type or nature to which the particular term does not apply, contain other terms which have, or make provision having, the same effect as those specified in Schedule 5 except paragraphs 30(6) to (8), 34(5) to (9), 35(5) to (17), 95(5) to (14) and 96.
(2) Paragraphs 30(6) to (8), 34(5) to (9), 35(5) to (17), 95(5) to (14) and 96 shall have effect in relation to the matters set out in those paragraphs.
PART 6RIGHT TO A GENERAL MEDICAL SERVICES CONTRACTRight to a general medical services contract 19. - (1) A contractor which is providing essential services and which wishes a general medical services contract to be entered into pursuant to this regulation shall notify the relevant body in writing at least three months before the date on which it wishes the general medical services contract to be entered into. (2) A notice under paragraph (1) shall - (a) state that the contractor wishes to terminate the agreement and the date on which the contractor wishes the agreement to terminate which must be at least three months after the date of service of the notice;
(b) subject to paragraph (3), give the name or names of the person or persons whom the contractor wishes the relevant body to enter into a general medical services contract with; and
(c) confirm that the person or persons so named meet the conditions set out in section 28S of the Act (persons eligible to enter into GMS contracts)[52] and regulations 4 and 5 of the General Medical Services Contracts Regulations or, where the contractor is not able so to confirm, the reason why it is not able to do so and confirmation that the person or persons immediately prior to entering into the general medical services contract will meet those conditions.
(3) A person's name may only be given in a notice referred to in paragraph (1) if that person is a party to the agreement.
(4) The relevant body shall acknowledge receipt of the notice served under paragraph (1) within the period of 7 days beginning on the day that it received the notice.
(5) Provided that the conditions set out in section 28S of the Act and regulations 4 and 5 of the General Medical Services Contracts Regulations are met, the relevant body shall enter into a general medical services contract with the person or persons named in the notice served under paragraph (1).
(6) In addition to the terms required by the Act and the General Medical Services Contracts Regulations, a general medical services contract entered into pursuant to this regulation shall provide for -
(a) the general medical services contract to commence immediately after the termination of the agreement;
(b) the names of the patients included in the contractor's list of patients immediately before the termination of the agreement to be included in the first list of patients to be prepared and maintained by the Primary Care Trust pursuant to paragraph 14 of Schedule 6 to the General Medical Services Contracts Regulations;
(c) the same services to be provided under the general medical services contract as were provided under the agreement immediately before it was terminated unless the parties otherwise agree; and
(d) the opt out of out of hours services referred to in paragraph (7) in accordance with the terms specified in Schedule 3 to the General Medical Services Contracts Regulations.
(7) The out of hours services are the services which the contractor was providing under the agreement pursuant to regulation 20 immediately before its termination and which the general medical services contract continues to require the contractor to provide.
(8) An agreement shall terminate on the date stated in the notice given by the contractor under paragraph (1) unless a different date is agreed by the contractor and the relevant body or no general medical services contract is entered into by the relevant body pursuant to this regulation.
(9) Where there is a dispute as to whether or not a person satisfies the conditions set out in section 28S of the Act or regulation 4 or 5 of the General Medical Services Contracts Regulations, the contractor may appeal to the FHSAA and the relevant body shall be the respondent.
(10) Any other dispute relating to this regulation shall be determined by the Secretary of State in accordance with regulation 9(2) and (3) of the General Medical Services Contracts Regulations.
(11) The parties to a dispute referred to the Secretary of State in accordance with paragraph (10) shall be the contractor and the relevant body.
PART 7TRANSITIONAL PROVISIONSOut of hours services 20.Subject to paragraph 8 of Schedule 5, an agreement under which essential services are to be provided before 1st January 2005 (whether or not such services will be provided after that date) must provide for out of hours services to be provided throughout the out of hours period unless - (a) the relevant body has accepted in writing, prior to the signing of the agreement, a written request from the contractor that the agreement should not require the contractor to make such provision;
(b) the contractor has opted out of providing such services in the out of hours period in accordance with paragraph 1 or 2 of Schedule 4; or
(c) the agreement has been otherwise varied to exclude a requirement to make such provision.
21.An agreement which includes the provision of out of hours services pursuant to regulation 20 must contain terms which have the same effect as those specified in Schedule 6.
Signed by authority of the Secretary of State
John Hutton
Minister of State, Department of Health
8th March 2004
SCHEDULE 1Regulation 2 REPEAT DISPENSING FORMSPART 1REPEATABLE PRESCRIPTION
PART 2
BATCH ISSUE
SCHEDULE 2Regulation 12
LIST OF PRESCRIBED MEDICAL CERTIFICATES
| Description of medical certificate | Short title of enactment under or for the purpose of which certificate required | 1.To support a claim or to obtain payment either personally or by proxy; to prove incapacity to work or for self-support for the purposes of an award by the Secretary of State; or to enable proxy to draw pensions etc
| Naval and Marine Pay and Pensions Act 1865[55] Air Force (Constitution) Act 1917[56] Pensions (Navy, Army, Air Force and Mercantile Marine) Act 1939[57] Personal Injuries (Emergency Provisions) Act 1939[58] Pensions (Mercantile Marine) Act 1942[59] Polish Resettlement Act 1947[60] Social Security Administration Act 1992[61] Social Security Contributions and Benefits Act 1992[62] Social Security Act 1998[63] | 2.To establish pregnancy for the purpose of obtaining welfare foods
| Section 13 of the Social Security Act 1988 (schemes for distribution etc of welfare foods)[64] | 3.To secure registration of still-birth
| Section 11 of the Births and Deaths Registration Act 1953 (special provision as to registration of still-birth[65] | 4.To enable payment to be made to an institution or other person in case of mental disorder of persons entitled to payment from public funds
| Section 142 of the Mental Health Act 1983 (pay, pensions etc of mentally disordered persons)[66] | 5.To establish unfitness for jury service
| Juries Act 1974[67] | 6.To support late application for reinstatement in civil employment or notification of non-availability to take up employment owing to sickness
| Reserve Forces (Safeguading of Employment) Act 1985[68]. | 7.To enable a person to be registered as an absent voter on grounds of physical incapacity
| Representation of the People Act 1983[69] | 8.To support applications for certificates conferring exemption from charges in respect of drugs, medicines and applicances
| National Health Service Act 1977[70] | 9.To support a claim by or on behalf of a severely mentally impaired person for exemption from liability to pay the Council Tax or eligibility for a discount in respect of the amount of Council Tax payable
| Local Government Finance Act 1992[71] |
SCHEDULE 3Regulation 15
FEES AND CHARGES
The contractor may demand or accept, directly or indirectly, a fee or other remuneration -
(a) from any statutory body for services rendered for the purposes of that body's statutory functions;
(b) from any body, employer or school for a routine medical examination of persons for whose welfare the body, employer or school is responsible, or an examination of such persons for the purpose of advising the body, employer or school of any administrative action they might take;
(c) for treatment which is not primary medical services or otherwise required to be provided under the agreement and which is given -
(i) pursuant to the provisions of section 65 of the Act (accommodation and services for private patients), or
(ii) in a registered nursing home which is not providing services under that Act,
if, in either case, the person administering the treatment is serving on the staff of a hospital providing services under the Act as a specialist providing treatment of the kind the patient requires and if, within 7 days of giving the treatment, the contractor or the person providing the treatment supplies the relevant body, on a form provided by it for the purpose, with such information about the treatment as it may require;
(d) under section 158 of the Road Traffic Act 1988 (payment for emergency treatment of traffic casualties)[72];
(e) when it treats a patient under regulation 15(3), in which case it shall be entitled to demand and accept a reasonable fee (recoverable in certain circumstances under regulation 15(4)) for any treatment given, if it gives the patient a receipt;
(f) for attending and examining (but not otherwise treating) a patient -
(i) at his request at a police station in connection with possible criminal proceedings against him,
(ii) at the request of a commercial, educational or not for profit organisation for the purpose of creating a medical report or certificate,
(iii) for the purpose of creating a medical report required in connection with an actual or potential claim for compensation by the patient;
(g) for treatment consisting of an immunisation for which no remuneration is payable by the relevant body and which is requested in connection with travel abroad;
(h) for prescribing or providing drugs, medicines or appliances (including a collection of such drugs, medicines or appliances in the form of a travel kit) which a patient requires to have in his possession solely in anticipation of the onset of an ailment or occurrence of an injury while he is outside the United Kingdom but for which he is not requiring treatment when the medicine is prescribed;
(i) for a medical examination -
(i) to enable a decision to be made whether or not it is inadvisable on medical grounds for a person to wear a seat belt, or
(ii) for the purpose of creating a report -
(aa) relating to a road traffic accident or criminal assault; or
(bb) that offers an opinion as to whether a patient is fit to travel;
(j) for testing the sight of a person to whom none of paragraphs (a), (b) or (c) of section 38(1) of the Act (arrangements for general ophthalmic services) applies (including by reason of regulations under section 38(6) of that Act);
(k) where it is a contractor which is authorised or required by a Primary Care Trust or a Strategic Health Authority under regulation 20 of the Pharmaceutical Regulations or paragraph 46, 48 or 49 of Schedule 5 to provide drugs, medicines or appliances to a patient and provides for that patient, otherwise than by way of pharmaceutical services or, as the case may be, dispensing services, any Scheduled drug; and
(l) for prescribing or providing drugs or medicines for malaria chemoprophylaxis.
SCHEDULE 4Regulation 16
OPT OUTS OF OUT OF HOURS SERVICES
Opt outs of out of hours services where the opt out notice is served after 30th September 2004
1. - (1) This paragraph applies where a contractor (other than a Primary Care Trust) serves an out of hours opt out notice after 30th September 2004.
(2) In this paragraph -
"OOH day" is the day specified by the contactor in its out of hours opt out notice to a Primary Care Trust for the commencement of the out of hours opt out; "B day" is the day six months after the date of service of the out of hours opt out notice; and "C day" is the day nine months after the date of service of the out of hours opt out notice. (3) A contractor which falls within regulation 16(1) or (2) and which wishes to terminate its obligation to provide out of hours services shall notify the Primary Care Trust in writing to that effect ("an out of hours opt out notice").
(4) An out of hours opt out notice shall specify the date from which the contractor would like the opt out to take effect, which must be either three or six months after the date of service of the out of hours opt out notice.
(5) As soon as is reasonably practicable and in any event within 28 days of receiving the out of hours opt out notice, the Primary Care Trust shall approve the notice and specify in accordance with sub-paragraph (6) the date on which the out of hours opt out is to commence ("OOH day"). The Primary Care Trust shall notify the contractor of its decision as soon as possible.
(6) The date specified in sub-paragraph (5) shall be the date specified in the out of hours opt out notice.
(7) A contractor may not withdraw an out of hours opt out notice once it has been approved by the Primary Care Trust under sub-paragraph (5) without the Primary Care Trust's agreement.
(8) Following receipt of the out of hours opt out notice, the Primary Care Trust must use its reasonable endeavours to make arrangements for the contractor's registered patients to receive the out of hours services from an alternative provider from OOH day.
(9) The contractor's duty to provide the out of hours services shall terminate on OOH day unless the Primary Care Trust serves a notice under sub-paragraph (10) (extending OOH day to B day or C day).
(10) If the Primary Care Trust is not successful in finding an alternative provider to take on the provision of the out of hours services from OOH day, then it shall notify the contractor in writing of this fact no later than one month before OOH day, and -
(a) in a case where OOH day is three months after service of the out of hours opt out notice, the contractor shall continue to provide the out of hours services until B day unless at least one month before B day it receives a notice in writing from the Primary Care Trust under sub-paragraph (11) that despite using its reasonable endeavours, it has failed to find an alternative provider to take on the provision of the out of hours services from B day;
(b) in a case where OOH day is six months after the service of the out of hours opt out notice, the contractor shall continue to provide the out of hours services until C day unless at least one month before C day it receives a notice from the Primary Care Trust under sub-paragraph (14) that it has made an application to the relevant Strategic Health Authority under sub-paragraph (13) seeking its approval of a decision to refuse an opt out or to delay the commencement of an opt out until after C day.
(11) Where in accordance with sub-paragraph (10)(a) the opt out is to commence on B day and the Primary Care Trust, despite using its reasonable endeavours has failed to find an alternative provider to take on the provision of the out of hours services from that day, it shall notify the contractor in writing of this fact at least one month before B day, in which case the contractor shall continue to provide the out of hours services until C day unless at least one month before C day it receives a notice from the Primary Care Trust under sub-paragraph (14) that it has applied to the relevant Strategic Health Authority under sub-paragraph (13) seeking the approval of the relevant Strategic Health Authority to a decision to refuse an opt out or to postpone the commencement of an opt out until after C day.
(12) As soon as is reasonably practicable and in any event within 7 days of the Primary Care Trust serving a notice under sub-paragraph (11), the Primary Care Trust shall enter into discussions with the contractor concerning the support that the Primary Care Trust may give to the contractor or other changes which the Primary Care Trust or the contractor may make in relation to the provision of the out of hours services until C day.
(13) The Primary Care Trust may, if it considers that there are exceptional circumstances, make an application to the relevant Strategic Health Authority for approval of a decision to -
(a) refuse an opt out; or
(b) postpone the commencement of an opt out until after C day.
(14) As soon as practicable after making an application under sub-paragraph (13) to the Strategic Health Authority, the Primary Care Trust shall notify the contractor in writing that it has made such an application.
(15) On receiving an application under sub-paragraph (13) for approval of a decision to refuse an opt out, the Strategic Health Authority shall -
(a) approve the Primary Care Trust's application;
(b) reject the Primary Care Trust's application, but nonetheless recommend a different date for the commencement of the opt out which shall be later than C day; or
(c) reject the Primary Care Trust's application.
(16) On receiving an application under sub-paragraph (13) for approval of a decision to postpone the commencement of an opt out until after C day, the Strategic Health Authority shall -
(17) The relevant Strategic Health Authority shall notify the Primary Care Trust and the contractor in writing of its decision under sub-paragraph (15) or (16) as soon as is practicable, including reasons for its decision.
(18) Where the Strategic Health Authority -
(a) approves a decision to refuse an opt out under sub-paragraph (15)(a); or
(b) recommends that an opt out be refused under sub-paragraph (16)(b)(ii),
the Primary Care Trust shall notify the contractor in writing that it may not opt out of the out of hours services.
(19) Where a Primary Care Trust notifies a contractor under sub-paragraph (18), the contractor may not serve an out of hours opt out notice for a period of 12 months beginning with the date of service of the Primary Care Trust's notice under sub-paragraph (18) unless there has been a change in the circumstances of the contractor which affects its ability to deliver services under the agreement.
(20) Where the Strategic Health Authority -
(a) recommends a different date for the commencement of the opt out under sub-paragraph (15)(b);
(b) approves a Primary Care Trust's application to postpone an opt out under sub-paragraph (16)(a); or
(c) recommends an earlier date to that proposed by the Primary Care Trust in its application under sub-paragraph (16)(b)(i),
the Primary Care Trust shall in accordance with the decision of the Strategic Health Authority notify the contractor in writing of its decision and the notice shall specify the date of the commencement of the opt out. The opt out shall commence from that date.
(21) Where the Strategic Health Authority rejects the Primary Care Trust's application under sub-paragraph (15)(c) or (16)(c), the Primary Care Trust shall notify the contractor in writing that there shall be an opt out and the opt out shall commence on C day or 28 days after the date of service of the Primary Care Trust's notice, whichever is the later.
(22) If the relevant Strategic Health Authority has not reached a decision on the Primary Care Trust's application under sub-paragraph (13) before C day, the contractor's obligation to provide the out of hours services shall continue until the date specified in sub-paragraph (20) or (21).
(23) Nothing in sub-paragraphs (2) to (22) above shall prevent the contractor and the Primary Care Trust from agreeing a different date for the termination of the contractor's duty under the agreement to provide the out of hours services and accordingly, varying the agreement in accordance with paragraph 98 of Schedule 5.
(24) The opt out takes effect at 08.00 on the relevant day unless -
(a) the day is a Saturday, Sunday, Good Friday, Christmas Day, or a bank holiday, in which case the opt out shall take effect on the next working day at 08.00; or
(b) the Primary Care Trust and the contractor agree a different day or time.
Opt outs of out of hours services where the opt out notice is served before 1st October 2004
2. - (1) This paragraph shall apply where a contractor (other than a Primary Care Trust) serves an out of hours opt out notice before 1st October 2004.
(2) In this paragraph -
"OOH day" is the day specified by the Primary Care Trust for the commencement of the out of hours opt out in its decision under sub-paragraph (5); "OOHB day" is the day six months after the date of service of the out of hours opt out notice; and "OOHC day" is the day specified by the Primary Care Trust it its decision under sub-paragraph (11) or (13) (which must be nine months after the date of service of the out of hours opt out notice or before 2nd January 2005). (3) A contractor which falls within regulation 16(1) and wishes to terminate its obligation to provide out of hours services shall notify the Primary Care Trust in writing to that effect ("an out of hours opt out notice").
(4) An out of hours opt out notice shall state the date on which the contractor would like the opt out to take effect, which must be either three or six months after the date of service of the out of hours opt out notice.
(5) As soon as is reasonably practicable and in any event within 28 days of receiving the out of hours opt out notice, the Primary Care Trust shall approve the notice and specify in accordance with sub-paragraphs (6) and (7) the date on which the out of hours opt out is to commence ("OOH day"). The Primary Care Trust shall notify the contractor in writing of its decision as soon as possible, including reasons for its decision.
(6) Subject to sub-paragraph (7), OOH day shall be -
(a) the date specified in the out of hours opt out notice; or
(b) any other date before 2nd January 2005.
(7) A Primary Care Trust may not specify under sub-paragraph (5) a date earlier than the date specified in the out of hours opt out notice.
(8) A contractor may not withdraw an out of hours opt out notice once it has been approved by a Primary Care Trust under sub-paragraph (5) without the Primary Care Trust's agreement.
(9) Following receipt of the out of hours opt out notice, the Primary Care Trust must use its reasonable endeavours to make arrangements for the contractor's registered patients to receive out of hours services from an alternative provider from OOH day.
(10) The contractor's duty to provide the out of hours services shall terminate on OOH day unless the Primary Care Trust -
(a) serves a notice under sub-paragraph (11) (extending OOH day to OOHB day or OOHC day); or
(b) makes an application under sub-paragraph (14) (seeking the approval of the relevant Strategic Health Authority to a decision to refuse an opt out or to delay the taking of effect of an opt out until after OOH day).
(11) If the Primary Care Trust is not successful in finding an alternative provider to take on the provision of the out of hours services from OOH day, then it shall notify the contractor in writing of this fact no later than one month before OOH day, and -
(a) in a case where OOH day is three months after service of the out of hours opt out notice, the contractor shall continue to provide the out of hours services until OOHB day unless at least one month before OOHB day it receives a notice in writing from the Primary Care Trust under sub-paragraph (13) that despite using its reasonable endeavours, it has failed to find an alternative provider to take on the provision of the out of hours services from OOHB day;
(b) in a case where OOH day is after the day three months after the service of the out of hours opt out notice, the contractor shall continue to provide the out of hours services until OOHC day (which shall be specified by the Primary Care Trust in accordance with sub-paragraph (12) and included in its notice to the contractor under this sub-paragraph) unless at least one month before OOHC day it receives a notice from the Primary Care Trust under sub-paragraph (16) that it has made an application to the relevant Strategic Health Authority under sub-paragraph (14) seeking its approval to a decision to refuse an opt out or to delay the commencement of the opt out until after OOHC day.
(12) OOHC day shall be any day before 2nd January 2005 or the day nine months after the service of the out of hours opt out notice.
(13) Where in accordance with sub-paragraph (11)(a) the out of hours opt out is to commence on OOHB day and the Primary Care Trust, despite using its reasonable endeavours has failed to find an alternative provider to take on the provision of the out of hours services from that day, it shall notify the contractor in writing of this fact at least one month before OOHB day, in which case the contractor shall continue to provide the out of hours services until OOHC day (which shall be specified by the Primary Care Trust in accordance with sub-paragraph (12) and included in its notice to the contractor under this sub-paragraph) unless at least one month before OOHC day it receives a notice from the Primary Care Trust under sub-paragraph (16) that it has applied to the relevant Strategic Health Authority under sub-paragraph (14) seeking the approval of the relevant Strategic Health Authority of a decision to refuse an opt out or to postpone the commencement of an opt out until after OOHC day.
(14) The Primary Care Trust may, if it considers there are exceptional circumstances, make an application to the relevant Strategic Health Authority for approval of a decision to -
(a) refuse an opt out; or
(b) postpone the commencement of an opt out until after -
(i) OOHC day, or
(ii) OOH day where OOH day is 1st January 2005 and 1st January 2005 is nine months or more after the date of the out of hours opt out notice.
(15) Where OOH day is 1st January 2005, and 1st January 2005 is nine months or more after the date of the out of hours opt out notice, an application under sub-paragraph (14) shall be made at least one month before OOH day.
(16) As soon as practicable after making an application under sub-paragraph (14) to the Strategic Health Authority, the Primary Care Trust shall notify the contractor in writing that it has made such an application.
(17) Sub-paragraphs (15) to (24) of paragraph 1 shall apply to an out of hours opt out notice served 1st October 2004 as they apply to an out of hours opt out notice served after 30th September 2004 and as if the reference to "C day" was a reference to OOHC day or OOH day where OOH day is 1st January 2005 and 1st January 2005 is nine months or more after the date of the out of hours opt out notice.
Informing patients of opt outs
3. - (1) Prior to any out of hours opt out taking effect, the Primary Care Trust and the contractor shall discuss how to inform patients of the proposed opt out.
(2) The contractor shall, if requested by the Primary Care Trust inform its registered patients of an opt out and the arrangements made for them to receive the out of hours services by -
(a) placing a notice in the contractor's waiting rooms; or
(b) including the information in the contractor's practice leaflet
SCHEDULE 5Regulation 18
OTHER CONTRACTUAL TERMS
PART 1
PROVISION OF SERVICES
Services to registered patients
1Where the agreement provides for a contractor to provide essential services, the contractor must -
(a) provide those services and such other services that it is required to provide to those patients, at such times, within core hours, as are appropriate to meet the reasonable needs of its patients; and
(b) have in place arrangements for its patients to access such services throughout the core hours in case of emergency.
Premises
2.Subject to any plan which is included in the agreement for bringing the contractor's premises up to the required standard, the contractor shall ensure that the premises used for the provision of services under the agreement are -
(a) suitable for the delivery of those services; and
(b) sufficient to meet the reasonable needs of the contractor's patients.
Attendance at practice premises
3. - (1) The contractor shall take steps to ensure that any patient who -
(a) has not previously made an appointment; and
(b) attends at the contractor's premises during the normal hours for essential services,
is provided with such services by an appropriate health care professional during that surgery period except in the circumstances specified in sub-paragraph (2).
(2) The circumstances referred to in sub-paragraph (1) are that -
(a) it is more appropriate for the patient to be referred elsewhere for services under the Act; or
(b) he is then offered an appointment to attend again within a time which is appropriate and reasonable having regard to all the circumstances and his health would not thereby be jeopardised.
Attendance outside practice premises
4. - (1) In the case of a patient whose medical condition is such that in the reasonable opinion of the contractor -
(a) attendance on the patient is required; and
(b) it would be inappropriate for him to attend at the contractor's premises,
the contractor shall provide services to that patient at whichever in its judgment is the most appropriate of the places set out in sub-paragraph (2).
(2) The places referred to in sub-paragraph (1) are -
(a) the place recorded in the patient's medical records as being his last home address;
(b) such other place as the contractor has informed the patient (and the relevant body) is the place where it has agreed to visit and treat the patient; or
(c) some other place in the contractor's practice area.
(3) Nothing in this paragraph prevents the contractor from -
(a) arranging for the referral of a patient without first seeing the patient, in a case where the medical condition of that patient makes that course of action appropriate; or
(b) visiting the patient in circumstances where this paragraph does not place it under an obligation to do so.
Clinical reports
5. - (1) Subject to sub-paragraph (4), where the contractor provides any clinical services, other than under a private arrangement, to a patient who is not on its list of patients it shall prepare a clinical report relating to the consultation, and any treatment provided.
(2) Subject to sub-paragraph (4), the contractor (other than a Primary Care Trust) shall as soon as reasonably practicable, provide a copy of the clinical report to the relevant body.
(3) The relevant body shall send any report prepared by it under sub-paragraph (1) or received by it under sub-paragraph (2) -
(a) to the person with whom the patient is registered for the provision of essential services (or their equivalent); or
(b) if the person referred to in paragraph (a) is not known to it, to the Primary Care Trust, Local Health Board, Health Board or Health and Social Services Board, in whose area the patient is resident unless it is that Primary Care Trust.
(4) This paragraph does not apply in relation to out of hours services provided by a contractor which is required pursuant to paragraph 9 to comply with the quality standards referred to in that paragraph.
Storage of vaccines
6.The contractor shall ensure that -
(a) all vaccines are stored in accordance with the manufacturer's instructions; and
(b) all refrigerators in which vaccines are stored have a maximum/minimum thermometer and that readings are taken on all working days.
Infection control
7.The contractor shall ensure that it has appropriate arrangements for infection control and decontamination.
Criteria for out of hours services
8.Except to the extent that the agreement otherwise provides, a contractor whose agreement includes the provision of out of hours services shall only be required to provide such services if, in the reasonable opinion of the contractor in the light of the patient's medical condition, it would not be reasonable in all the circumstances for the patient to wait for the services required until the next time at which he could obtain such services during core hours.
Standards for out of hours services
9. - (1) A contractor which provides out of hours services to registered patients of another contractor or provider of essential services (or their equivalent) and who does not fall within sub-paragraph (2), must, in the provision of out of hours services, meet the quality standards set out in the document entitled "Quality Standards in the Delivery of GP Out of Hours Services" published on 20th June 2002[73].
(2) A contractor which has contracted to provide out of hours services only to patients which it provides essential services to under the agreement, must from 1st January 2005, in the provision of such out of hours services, meet the quality standards set out in the document entitled "Quality Standards in the Delivery of GP Out of Hours Services" published on 20th June 2002.
Duty of co-operation
10. - (1) A contractor which does not provide to its registered patients or to persons whom it has accepted as temporary residents -
(a) a particular service; or
(b) out of hours services, either at all or in respect of some periods or some services,
shall comply with the requirements specified in sub-paragraph (2).
(2) The requirements referred to in sub-paragraph (1) are that the contractor shall -
(a) co-operate in so far as is reasonable with any person responsible for the provision of that service or those services;
(b) comply in core hours with any reasonable request for information from such a person or from the relevant body relating to the provision of that service or those services; and
(c) in the case of out of hours services, take reasonable steps to ensure that any patient who contacts the contractor's premises during the out of hours period is provided with information about how to obtain services during that period.
(3) Nothing in this paragraph shall require a contractor whose agreement does not include the provision of out of hours services to make itself available during the out of hours period.
11.Where a contractor is to cease to be required to provide to its patients -
(a) a particular service; or
(b) out of hours services, either at all or in respect of some periods or some services,
it shall comply with any reasonable request for information relating to the provision of that service or those services made by the relevant body or by any person with whom the relevant body intends to enter into an agreement, general medical services contract or other contract for the provision of such services or any Primary Care Trust in whose area its registered patients reside.
PART 2
PATIENTS
General Provision
12. - (1) This Part shall apply to contractors which provide essential services.
(2) Where the contractor is a Primary Care Trust which provides essential services under the agreement this Part shall apply as modified in accordance with Schedule 7.
List of patients
13.Where the agreement requires the contractor to provide essential services, the Primary Care Trust shall prepare and keep up to date a list of the patients -
(a) who have been accepted by the contractor for inclusion in its list of patients under paragraph 14 and who have not subsequently been removed from that list under paragraphs 18 to 26; and
(b) who have been assigned to the contractor under paragraph 31 or 32 and whose assignment has not subsequently been rescinded.
Application for inclusion in a list of patients
14. - (1) The contractor may, if its list of patients is open, accept an application for inclusion in its list of patients made by or on behalf of any person whether or not resident in its practice area or included, at the time of that application, in the list of patients of another contractor or provider of primary medical services.
(2) The contractor may, if its list of patients is closed, only accept an application for inclusion in its list of patients from a person who is an immediate family member of a registered patient whether or not resident in its practice area or included, at the time of that application, in the list of patients of another contractor or provider of primary medical services.
(3) Subject to sub-paragraph (4), an application for inclusion in a contractor's list of patients shall be made by delivering to the contractor's premises a medical card or an application signed (in either case) by the applicant or a person authorised by the applicant to sign on his behalf.
(4) An application may be made -
(a) on behalf of any child -
(i) by either parent, or in the absence of both parents, the guardian or other adult who has care of the child,
(ii) by a person duly authorised by a local authority to whose care the child has been committed under the Children Act 1989[74], or
(iii) by a person duly authorised by a voluntary organisation by which the child is being accommodated under the provisions of that Act; or
(b) on behalf of any adult who is incapable of making such an application, or authorising such an application to be made on their behalf, by a relative or the primary carer of that person.
(5) A contractor which accepts an application for inclusion in its list of patients shall notify the Primary Care Trust in writing as soon as possible.
(6) On receipt of a notice under sub-paragraph (5), the Primary Care Trust shall -
(a) include that person in the contractor's list of patients from the date on which the notice is received; and
(b) notify the applicant (or, in the case of a child or incapable adult, the person making the application on their behalf) of the acceptance.
Temporary residents
15. - (1) The contractor may, if its list of patients is open, accept a person as a temporary resident provided it is satisfied that the person is -
(a) temporarily resident away from his normal place of residence and is not being provided with essential services (or their equivalent) under any other arrangement in the locality where he is temporarily residing; or
(b) moving from place to place and not for the time being resident in any place.
(2) For the purposes of sub-paragraph (1), a person shall be regarded as temporarily resident in a place if, when he arrives in that place, he intends to stay there for more than 24 hours but not more than three months.
(3) A contractor which wishes to terminate its responsibilit |
