The National Health Service (General Medical Services Contracts) Regulations 2015
Made: 6th November 2015
Laid before Parliament: 13th November 2015
Coming into force: 7th December 2015
The Secretary of State for Health, in exercise of the powers conferred by sections 9(8), 83(3), (6), 85(1), 86(1) and (4), 89(1), (1A)(a) and (b), (3) and (4), 90(1), (3), 91(1), 97(6) and (8), 187 and 272(7) and (8) of the National Health Service Act 2006 , makes the following Regulations.
PART 1 — General
Citation and commencement
1
- (1) These Regulations may be cited as the National Health Service (General Medical Services Contracts) Regulations 2015.
- (2) They come into force on 7th December 2015.
Application
2
These Regulations apply to a contract—
- (a) to which the National Health Service (General Medical Services Contracts) Regulations 2004 applied immediately before the date on which these Regulations come into force; or
- (b) which is entered into between a contractor and NHS England on or after that date.
Interpretation
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- (1) In these Regulations—
- “the Act” means the National Health Service Act 2006;
- “2004 Regulations” means the National Health Service (General Medical Services Contracts) Regulations 2004;
- “2010 Order” means the Postgraduate Medical Education and Training Order of Council 2010 ;
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- “adjudicator” means the Secretary of State or one or more people appointed by the Secretary of State under section 9(8) of the Act (NHS contracts) or under regulation 83(5)(b);
- “advanced electronic signature” means an electronic signature which meets the following requirements—it is uniquely linked to the signatory;it is capable of identifying the signatory;it is created using electronic signature creation data that the signatory can, with a high level of confidence, use under the signatory’s sole control; andit is linked to the data signed in such a way that any subsequent change in the data is detectable;
- “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 126 of the Act (arrangements for pharmaceutical services);
- “appropriate person”—in relation to a person who has not attained the age of 16 years, means a person mentioned in paragraph 18(4)(a)(i), (ii) or (iii) of Schedule 3;in relation to a person who lacks capacity—to make an application or provide information to, to accept an offer from, or otherwise communicate with, the contractor, orto authorise the making of an application or provision of information to, the acceptance of an offer from, or other communication with, the contractor on their behalf,means a person mentioned in paragraph 18(4)(b)(i), (ii), (iii) or (iv) of Schedule 3;
- “armed forces of the Crown” means the forces that are “regular forces” or “reserve forces” within the meaning given in section 374 of the Armed Forces Act 2006 ;
- “assessment panel” means the panel appointed by NHS England for the purpose of making determinations under paragraph 41(7) of Schedule 3;
- “authorised person”, in relation to a patient, is a person who is entitled to make an application for pharmaceutical services on behalf of the patient by virtue of regulation 116(a) to (c) of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (authorised persons to apply for services);
- “bank holiday” means any day that is specified or proclaimed as a bank holiday in England and Wales under section 1 of the Banking and Financial Dealings Act 1971 (bank holidays);
- “batch issue” means a form, in the format required by NHS England and approved by the Secretary of State, which—is issued by a repeatable prescriber at the same time as a non-electronic repeatable prescription to enable a chemist or person who provides dispensing services to receive payment for the provision of repeat dispensing services;relates to a particular non-electronic repeatable prescription and contains the same date as that prescription;is generated by a computer and not signed by a repeatable prescriber;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 non-electronic repeatable prescription may be provided; andhas included on it a number denoting its place in the sequence referred to in paragraph (d);
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- “Care Quality Commission” means the body established under section 1 of the Health and Social Care Act 2008 (The Care Quality Commission);
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- “CCT” means a certificate of completion of training awarded under section 34L(1) of the Medical Act 1983 (award and withdrawal of a Certificate of Completion of Training) ...;
- “cervical screening services” has the meaning given in paragraph (2);
- “charity trustee” means one of the persons having the general control, management and administration of a charity;
- “chemist” means—a person lawfully conducting a retail pharmacy business in accordance with section 69 of the Medicines Act 1968 (general provisions); ora supplier of appliances,who is included in the list held by NHS England under section 129 of the Act (regulations as to pharmaceutical services), or a local pharmaceutical services scheme made under Schedule 12 to the Act (LPS Schemes);
- “child” , other than in Part 2A of Schedule 3, means a person who has not attained the age of 16 years;
- “child health surveillance services” has the meaning given in paragraph (3);
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- “chiropodist or podiatrist independent prescriber” means a person—who is engaged or employed by the contractor or is a party to the contract; andwho is registered in Part 2 of the register maintained under article 5 of the Health Professions Order 2001 (establishment and maintenance of register), and against whose name in that register is recorded an annotation signifying that the chiropodist or podiatrist is qualified to order drugs, medicines and appliances as a chiropodist or podiatrist independent prescriber;
- “clinical services” means medical services under the contract which relate to the actual observation and treatment of patients;
- “closed”, in relation to a 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;
- “contraceptive services” means the following services—the giving of advice about the full range of contraceptive methods;where appropriate, the medical examination of patients seeking such advice;the treatment of such patients for contraceptive purposes and the prescribing of contraceptive substances and appliances (excluding the fitting and implanting of intrauterine devices and implants);the giving of advice about emergency contraception and, where appropriate, the supplying or prescribing of emergency hormonal contraception;the giving of advice and referral in cases of unplanned pregnancy including advice about the availability of free pregnancy testing in the contractor’s practice area;the giving of initial advice about sexual health promotion and sexually transmitted infections; andthe referral as necessary to specialist sexual health services, including tests for sexually transmitted infections;
- “contract”, except in regulation 96 and in the definitions of “contract of engagement” and “third party contract” in regulation 27AA, means a general medical services contract made under section 84(2) of the Act (general medical services contracts: introductory);
- “contractor”, except in regulation 6, has the meaning given in section 84(5) of the Act (general medical services contracts: introductory);
- “contractor’s EPS phase 4 date” means the date, encoded within the Electronic Prescription Service software, which is the date that a contractor has agreed is to be the date on and after which the contractor’s prescribers are to use the Electronic Prescription Service for all eligible prescriptions;
- “contractor's list of patients” means the list prepared and maintained by NHS England under paragraph 17 of Schedule 3;
- “core hours” means , subject to regulation 3A(1), the period beginning at 8.00am and ending at 6.30pm on any day from Monday to Friday except Good Friday, Christmas Day or bank holidays;
- “digital practice area map” means a map of the practice area produced on digital tools provided by NHS England;
- “directly bookable appointment” means an appointment of a type which, in line with the guidance entitled “Directly bookable appointments – guidance for practices” issued by NHS England, is available for booking by a registered patient or an appropriate person on their behalf;
- “dispenser” means a chemist, medical practitioner or contractor whom a patient wishes to dispense the patient's electronic prescriptions;
- “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 under section 126 (arrangements for pharmaceutical services) and section 132 (persons authorised to provide pharmaceutical services) of the Act ;
- “Drug Tariff” means the publication known as the Drug Tariff which is published by the Secretary of State and which is referred to in section 127(4) of the Act (arrangements for additional pharmaceutical services);
- “electronic communication” has the meaning given in section 15 of the Electronic Communications Act 2000 (general interpretation);
- “electronic prescription” means an electronic prescription form or an electronic repeatable prescription;
- “electronic prescription form” means a prescription form which falls within paragraph (b) of the definition of “prescription form”;
- “Electronic Prescription Service” means the service of that name which is managed by NHS England;
- “electronic repeatable prescription” means a prescription which falls within paragraph (b) of the definition of “repeatable prescription”;
- “electronic signature” means data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign;
- “electronic signature creation data” means unique data which is used by the signatory to create an electronic signature;
- “English health service medicine” means a medicinal product used to any extent for the purposes of the health service continued under section 1(1) of the Act;
- “enhanced services” are—services other than essential services, minor surgery or out of hours services; oressential services, minor surgery or out of hours services, or an element of such a service, that a contractor agrees under the contract to provide in accordance with specifications set out in a plan, which requires of the contractor an enhanced level of service provision compared to that which it needs generally to provide in relation to that service or element of that service;
- “EPS token” means a form (which may be an electronic form), approved by the Secretary of State, which—is issued by a prescriber at the same time as an electronic prescription is created; andhas a barcode that enables the prescription to be dispensed by a provider of pharmaceutical services that is able to use the Electronic Prescription Service for the purposes of dispensing prescriptions, in circumstances where the provider is not dispensing the prescription as a nominated dispenser;
- “essential services” means the services required to be provided in accordance with regulation 17;
- “financial year” has the meaning given in section 275(1) of the Act (interpretation);
- “general medical practitioner” means a medical practitioner whose name is included in the General Practitioner Register kept by the General Medical Council under section 2 of the Medical Act 1983 (registration of medical practitioners);
- “GPIT Operating Model” means the document entitled “Securing Excellence in Primary Care (GP) Digital Services: The Primary Care (GP) Digital Services Operating Model 2021-23 V5” issued by NHS England;
- “global sum” has the meaning given in the GMS Statement of Financial Entitlements;
- “GMS Statement of Financial Entitlements” means the directions given by the Secretary of State under section 87 of the Act (GMS contracts: payments);
- “GP Specialty Registrar” means a general medical practitioner who is being trained in general practice by a general medical practitioner who is approved under section 34I(1)(c) of the Medical Act 1983 (postgraduate education and training: approvals) for the purpose of providing training in accordance with that section, whether as part of training leading to a CCT or otherwise;
- “Health and Social Services Board” means a Health and Social Services Board established under article 16 of the Health and Social Services (Northern Ireland) Order 1972 (establishment of Health and Social Services Boards);
- “Health and Social Services Trust” means a Health and Social Services Trust established under article 10 of the Health and Personal Services (Northern Ireland) Order 1991 (ancillary services);
- “Health Board” means a Health Board established under section 2 of the National Health Service (Scotland) Act 1978 (Health Boards);
- “health care professional” has the meaning given in section 108 of the Act (participants in section 107 arrangements) and “health care profession” is to be construed accordingly;
- “health service body” has the meaning given in section 9(4) of the Act (NHS contracts);
- “home oxygen order form” means a form provided by NHS England and issued by a health care professional to authorise a person to supply home oxygen services to a patient requiring oxygen therapy at home;
- “home oxygen services” means any of the following forms of oxygen therapy or supply—ambulatory oxygen supply;urgent supply;hospital discharge supply;long term oxygen therapy; andshort burst oxygen therapy;
- “immediate family member” means—a spouse or civil partner;a person whose relationship with the registered patient has the characteristics of the relationship between spouses;a parent or step-parent;a son or daughter;a child of whom the registered patient is—the guardian, orthe carer duly authorised by the local authority to whose care the child has been committed under the Children Act 1989 ; ora grandparent;
- “independent nurse prescriber” means a person—who is either engaged or employed by the contractor or who is a party to the contract;who is registered in the Nursing and Midwifery Register; andagainst whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines or appliances as a community practitioner nurse prescriber, a nurse independent prescriber or as a nurse independent/supplementary prescriber;
- “integrated care board” means an integrated care board established under Chapter A3 of Part 2 of the Act;
- “licensing body” means a body that licenses or regulates a profession;
- “limited partnership” means a partnership registered in accordance with section 5 of the Limited Partnerships Act 1907 (registration of limited partnerships required);
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- “listed prescription items” means the prescription items mentioned in regulation 13(1) of the National Health Service (Charges for Drugs and Appliances) Regulations 2015 (exemption from charges: risks to public health);
- “listed prescription items voucher” means a form which—is provided or approved by NHS England for the purposes of ordering a prescription item mentioned in regulation 13(1) of the National Health Service (Charges for Drugs and Appliances) Regulations 2015; andmay be an electronic form sent or to be sent via a secure service approved for this purpose by NHS England;
- “Local Health Board” means a body established under section 11 of the National Health Service (Wales) Act 2006 (Local Health Boards);
- “Local Medical Committee” means a committee recognised by NHS England under section 97 of the Act (local medical committees);
- “maternity medical services” has the meaning given in paragraph (4);
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- “medical performers list” means the list of medical practitioners maintained and published by NHS England in accordance with section 91 of the Act (persons performing primary medical services);
- “Medical Register” means the registers kept under section 2 of the Medical Act 1983 (registration of medical practitioners);
- “minor surgery” has the meaning given in paragraph (6A);
- “national disqualification” means—a decision made by the First Tier Tribunal under section 159 of the Act (national disqualification) or under regulations corresponding to that section made under—section 91(3) of the Act (persons performing primary medical services),section 106(3) of the Act (persons performing primary dental services),section 123(3) of the Act (persons performing primary ophthalmic services), andsections 145, 146, 147A or 149 (performers of pharmaceutical services and assistants),of the Act ; ora decision under provisions in force in Wales, Scotland or Northern Ireland corresponding to section 159 of the Act (national disqualification);
- “NHS contract” has the meaning given in section 9 of the Act (NHS contracts);
- “NHS dispute resolution procedure” means the procedure for the resolution of disputes specified—in Part 12; orin a case to which paragraph 42 of Schedule 3 applies, in that paragraph;
- “NHS England” means the body corporate established under section 1H of the Act;
- “NHS foundation trust” has the meaning given in section 30 of the Act (NHS foundation trusts);
- “NHS trust” means a body established under section 25 of the Act (NHS trusts);
- “nominated dispenser” means a chemist, medical practitioner or contractor who has been nominated in respect of a patient where the details of that nomination are held in respect of that patient in the Patient Demographics Service which is managed by NHS England;
- “non-electronic prescription form” means a prescription form which falls within paragraph (a) of the definition of “prescription form”;
- “non-electronic repeatable prescription” means a prescription form for the purpose of ordering a drug, medicine or appliance which—is provided by NHS England, a local authority or the Secretary of State;is issued, or is to be issued, by the prescriber;indicates that the drug, medicine or appliance ordered may be provided more than once; andspecifies, or is to specify, the number of occasions on which the drag, medicine or appliance may be provided;
- “normal hours” means those days and hours on which and the times at which services under the contract are normally made available and normal hours may be different for different services;
- “Nursing and Midwifery Register” means the register maintained by the Nursing and Midwifery Council under article 5 of the Nursing and Midwifery Order 2001 (establishment and maintenance of register);
- “online consultation tool” has the meaning given in regulation 71ZD(2);
- “online practice profile” has the meaning given in regulation 73(7);
- “open”, in relation to a contractor's list of patients, means open to applications from patients in accordance with paragraph 18 of Schedule 3;
- “optometrist independent prescriber” means a person—who is registered in the register of optometrists maintained under section 7(a) of the Opticians Act 1989 (register of opticians); andagainst whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines and appliances as an optometrist independent prescriber;
- “out of hours period” means subject to regulation 3A(2)—the period beginning at 6.30pm on any day from Monday to Thursday and ending at 8.00am on the following day;the period beginning at 6.30pm on Friday and ending at 8.00am on the following Monday; andGood 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 the services required to be provided in all or part of the out of hours period which—would be essential services if provided by a contractor to its registered patients in core hours; orare included in the contract as minor surgery funded under the global sum;
- “paramedic independent prescriber” means a person—who is either engaged or employed by the contractor or who is a party to the contract;who is registered in the register maintained by the Health and Care Professions Council under article 5 of the Health Professions Order 2001 (establishment and maintenance of register); andagainst whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines or appliances as a paramedic independent prescriber;
- “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 their child;
- “patient” means—a registered patient;a temporary resident;persons to whom the contractor is required to provide immediately necessary treatment under regulation 17(7) or (9) respectively;any other person to whom the contractor has agreed to provide services under the contract; andany person in respect of whom the contractor is responsible for the provision of out of hours services;
- “performer” means a performer of medical services under the contract to whom the provisions of Part 7 of these Regulations apply;
- “pharmacist independent prescriber” means a person—who is either engaged or employed by the contractor or is a party to the contract;who is registered in Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (establishment, maintenance of and access to the register) or the register maintained under article 6 (the Register) and article 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 1976 ; andagainst whose name in that register is recorded an annotation signifying that that person is qualified to order drugs, medicines and appliances as a pharmacist independent prescriber;
- “physiotherapist independent prescriber” means a person who is—engaged or employed by the contractor or is a party to the contract; andregistered in Part 9 of the register maintained under article 5 of the Health Professions Order 2001 (establishment and maintenance of register), and against whose name in that register is recorded an annotation signifying that that physiotherapist is qualified to order drugs, medicines and appliances as a physiotherapist independent prescriber;
- “post registration programme” means a programme that is for the time being recognised by the General Medical Council under regulation 10A of the Medical Act 1983 (programmes for provisionally registered doctors) as providing provisionally registered doctors with an acceptable foundation for future practise as a fully registered medical practitioner;
- “practice” means the business operated by the contractor for the purpose of delivering services under the contract;
- “practice area” means the area referred to in regulation 20(1)(d);
- “practice leaflet” means a leaflet drawn up in accordance with regulation 78;
- “practice premises” means an address specified in the contract as one at which services are to be provided under the contract;
- “practice website” means a website through which the contractor advertises the primary medical services it provides;
- “prescriber” means—a chiropodist or podiatrist independent prescriber;an independent nurse prescriber;a medical practitioner;an optometrist independent prescriber;a paramedic independent prescriber;a pharmacist independent prescriber;a physiotherapist independent prescriber;a supplementary prescriber; anda therapeutic radiographer independent prescriber;
- “prescription form” means—a form for the purpose of ordering a drug, medicine or appliance which—is provided by NHS England , a local authority or the Secretary of State and is in the format required by the NHS Business Services Authority ,is issued, or is to be issued, by the prescriber, anddoes not indicate that the drug, medicine or appliance ordered may be provided more than once; orin the case of an electronic prescription to which regulation 57 applies, data created in an electronic form for the purpose of ordering a drug, medicine or appliance, which—is signed, or is to be signed, with a prescriber's advanced electronic signature,is transmitted, or is to be transmitted, as an electronic communication to a nominated dispenser or via an information hub by the Electronic Prescription Service, anddoes not indicate that the drug, medicine or appliance ordered may be provided more than once;
- “prescription only medicine” means a medicine referred to in regulation 5(3) of the Human Medicines Regulations 2012 (classification of medicinal products);
- “primary care list” means—a list of persons performing primary medical services, primary dental services, primary ophthalmic services or pharmaceutical services prepared in accordance with regulations made under—section 91 of the Act (persons performing primary medical services),section 106 of the Act (persons performing primary dental services),section 123 of the Act (persons performing primary ophthalmic services), orsections 145, 146, 147A or 149 (performers of pharmaceutical services and assistants),of the Act ;a list of persons undertaking to provide, or assist in the provision of—primary medical services in accordance with regulations made under Part 4 of the Act (primary medical services),primary dental services in accordance with regulations made under Part 5 of the Act (primary dental services),primary ophthalmic services in accordance with regulations made under Part 6 of the Act (primary ophthalmic services), andpharmaceutical services in accordance with regulations made under Part 7 of the Act (pharmaceutical services and local pharmaceutical services); ora list corresponding to any of the above in Wales, Scotland or Northern Ireland;
- “Primary Care Trust” means the Primary Care Trust which was a party to the contract immediately before the coming into force of section 34 of the Health and Social Care Act 2012 (abolition of primary care trusts);
- “primary carer” means, in relation to an adult, the adult or organisation primarily caring for that adult;
- “primary medical services” means medical services provided under or by virtue of a contract or agreement to which the provisions of Part 4 of the Act applies;
- “Primary Medical Services (Directed Enhanced Services) Directions” means directions relating to provision of enhanced services given to NHS England under section 98A(3) of the Act;
- “private services” means the provision of any treatment which would amount to primary medical services if it were provided under or by virtue of a contract or agreement to which the provisions of Part 4 of the Act apply;
- “registered patient” means—a person who is recorded by NHS England as being on the contractor's list of patients; ora person whom the contractor has accepted for inclusion in its list of patients, whether or not notification of that acceptance has been received by NHS England, and who has not been notified by NHS England as having ceased to be on that list;
- “relevant register” means—in relation to a nurse, the Nursing and Midwifery Register;in relation to a pharmacist, Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (establishment, maintenance of and access to the register) or the register maintained under article 6 (the Register) and article 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 1976 ;in relation to an optometrist, the register maintained by the General Optical Council in pursuance of section 7(a) of the Opticians Act 1989 (register of opticians); andthe part of the register maintained by the Health and Care Professions Council under article 5 of the Health Professions Order 2001 (establishment and maintenance of register) relating to— chiropodists and podiatrists, paramedics, physiotherapists, or radiographers;
- “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;
- “remote consultation” means a consultation under the contract in which a patient, or their representative, participates by any means permitted under the contract, other than in person;
- “remote service” means a service under the contract which is—an online consultation under regulation 71ZD;a secure electronic communication under regulation 71ZE;a video consultation under regulation 71ZF;a telephone consultation;an electronic prescription;any other service which can be provided through a digital or telecommunications method, including administrative tasks in support of the contract;
- “repeatable prescriber” means a prescriber who is—engaged or employed by a contractor which provides repeatable prescribing services under the terms of its contract which give effect to regulation 59; ora party to a contract under which such services are provided;
- “repeatable prescribing services” means services which involve the prescribing of drugs, medicines or appliances on a repeatable prescription;
- “repeatable prescription” means—a form provided by NHS England, a local authority or Secretary of State for the purpose of ordering a drug, medicine or appliance which is in the format required by the NHS Business Services Authority and which—is issued, or is to be issued, by a repeatable prescriber to enable a chemist or person providing dispensing services to receive payment for the provision of repeat dispensing services,indicates, or is to indicate, that the drug, medicine or appliance ordered may be provided more than once, andspecifies, or is to specify, the number of occasions on which the drug, medicine or appliance may be provided; orin the case of an electronic prescription to which regulation 57 applies, data created in an electronic form for the purpose of ordering a drug, medicine or appliance, which—is signed, or is to be signed, with a prescriber’s advanced electronic signature,is transmitted, or is to be transmitted, as an electronic communication to a nominated dispenser or via an information hub by the Electronic Prescription Service, andindicates, or is to indicate, that the drug, medicine or appliance ordered may be provided more than once and specifies, or is to specify, the number of occasions on which the drug, medicine or appliance may be provided;
- “restricted availability appliance” means an appliance which is approved for particular categories of persons or for particular purposes only;
- “Scheduled drug” means—a drug, medicine or other substance specified in any directions given by the Secretary of State under section 88 of the Act (GMS contracts: prescription of drugs etc.) as being a drug, medicine or other substance which may not be ordered for patients in the provision of medical services under the contract; orexcept where the conditions in regulation 61(3) are satisfied, a drug, medicine or other substance which is specified in any directions given by the Secretary of State under section 88 of the Act as being a drug, medicine or other substance which can only be ordered for specified patients and specified purposes;
- “section 92 provider” means a person who is providing services in accordance with arrangements under section 92 of the Act (arrangements for the provision of primary medical services);
- “service provider” has the meaning given in regulation 2 of the Care Quality Commission (Registration) Regulations 2009 (interpretation);
- “signatory” means a natural person who creates an electronic signature;
- “supplementary prescriber” means a person—who is either engaged or employed by the contractor or is a party to the contract;whose name is registered in—the Nursing and Midwifery Register,Part 1 of the register maintained under article 19 of the Pharmacy Order 2010 (establishment, maintenance of and access to the register),the register maintained under article 6 (the Register) and article 9 (the Registrar) of the Pharmacy (Northern Ireland) Order 1976 , the register maintained by the Health and Care Professions Council under article 5 of the Health Professions Order 2001 (establishment and maintenance of register) relating to— chiropodists and podiatrists,dieticians,paramedics,physiotherapists, orradiographers, orthe register of optometrists maintained by the General Optical Council under section 7(a) of the Opticians Act 1989 (register of opticians); andagainst whose name is recorded in the relevant register an annotation or entry signifying that that person is qualified to order drugs, medicines and appliances as a supplementary prescriber or, in the case of the Nursing and Midwifery Register, a nurse independent/supplementary prescriber;
- “temporary resident” means a person—accepted by the contractor as a temporary resident under paragraph 20, 32E or 32G of Schedule 3, andfor whom the contractor’s responsibility has not terminated under paragraph 20, 32E or 32G (as the case may be) of Schedule 3.
- “therapeutic radiographer independent prescriber” means a radiographer—who is registered in Part 11 of the register maintained under article 5 of the Health Professions Order 2001; andagainst whose name in that register is recorded—an entitlement to use the title “therapeutic radiographer”, andan annotation signifying that the radiographer is qualified to order drugs, medicines and appliances as a therapeutic radiographer independent prescriber;
- “vaccine and immunisation services” has the meaning given in paragraph (7);
- “working day” means any day except Saturday, Sunday, Christmas Day, Good Friday or a bank holiday; and
- “writing”, except in paragraph 57 of Schedule 3, includes electronic mail and “written” is to be construed accordingly.
- (2) “Cervical screening services” means the following services—
- (a) providing necessary information and advice to assist women who are identified by NHS England as recommended nationally for a cervical screening test in making an informed decision as to their participation in the NHS Cervical Screening Programme ;
- (b) performing cervical screening tests on women who have agreed to participate in that programme;
- (c) ensuring that test results are followed up appropriately;
- (d) where a cervical screening test is performed on a woman, recording in the patient’s record—
- (i) the carrying out of the test,
- (ii) the result of the test, and
- (iii) any clinical follow up requirements.
- (3) “Child health surveillance services” means the following services—
- (a) monitoring the health, well-being and physical, mental and social development (“development”) of a patient who has not attained the age of five years (a “relevant patient”) with a view to detecting any deviations from normal development—
- (i) by the consideration of information concerning the relevant patient received by or on behalf of the contractor, and
- (ii) on any occasion when the relevant patient is examined or observed by or on behalf of the contractor (whether by virtue of sub-paragraph (c) or otherwise);
- (b) offering to the parent of the relevant patient an examination of the relevant patient at the frequency that has been agreed with NHS England in accordance with the nationally agreed evidence based programme set out in the fifth edition of “Health for all Children” ;
- (c) where any offer of an examination under sub-paragraph (b) is accepted, carrying out the examination of the relevant patient;
- (d) maintaining, in the relevant patient’s record, an accurate record of the development of the patient whilst under the age of five years, which is compiled as soon as reasonably practicable following the first examination of the relevant patient and, where appropriate, amended following each subsequent examination;
- (e) recording in the relevant patient’s record the response (if any) to any offer of an examination under sub-paragraph (b).
- (4) “Maternity medical services” means the following services—
- (a) providing to expectant mothers all necessary relevant services throughout the antenatal period;
- (b) providing to mothers and their babies (if relevant) all necessary relevant services throughout the postnatal period other than neonatal checks;
- (c) inviting each mother who gives birth to a child to attend a maternal postnatal consultation;
- (d) where the invitation is accepted, providing the mother with such a consultation—
- (i) otherwise than at the same time as any consultation at which the physical health of the baby is reviewed (if relevant), and
- (ii) wherever possible, within the postnatal consultation period;
- (e) providing all necessary relevant services to patients whose pregnancy has terminated as a result of miscarriage or abortion.
- (5) For the purposes of paragraph (4)(c) “child” includes a still-born child within the meaning of the Births and Deaths Registration Act 1953 (see section 41(1) of that Act).
- (6) For the purposes of paragraph (4)—
- “antenatal period” means the period beginning with the start of the pregnancy and ending with the onset of labour;
- “maternal postnatal consultation” means a consultation with a general medical practitioner, at which the physical and mental health and well-being of the mother is reviewed;
- “postnatal consultation period” means the period which—begins six weeks after the conclusion of the delivery of the baby, andends—eight weeks after the conclusion of the delivery, orif the mother has not been discharged from secondary care services before the end of that period, eight weeks after the mother’s discharge from secondary care services;
- “postnatal period” means the period which—begins with the later of—the conclusion of the delivery of the baby, andthe mother’s discharge from secondary care services, andends eight weeks after the conclusion of the delivery;
- “relevant services”—in relation to a patient (other than a baby), means all primary medical services relating to pregnancy, excluding intra partum care;in relation to a baby, means any primary medical services necessary in their first eight weeks of life.
- (6A) “Minor surgery” means the following services—
- (a) making available to patients where appropriate—
- (i) curettage,
- (ii) cautery, and
- (iii) cryocautery of warts, verrucae and other skin lesions;
- (b) recording in the patient’s record—
- (i) details of the minor surgery provided to the patient, and
- (ii) the consent of the patient to that surgery.
- (7) “Vaccine and immunisation services” means the following services—
- (a) offering to administer or provide to patients all vaccines and immunisations of the type, and in the circumstances which are, specified in the GMS Statement of Financial Entitlements;
- (b) providing appropriate information and advice to patients and, where appropriate, to the parents of patients, about such vaccines and immunisations;
- (c) in relation to patients other than children and taking into account the individual circumstances of the patient, considering whether—
- (i) immunisation ought to be administered by the contractor or by another health care professional, or
- (ii) a prescription form ought to be provided for the purpose of self-administration by the patient of the immunisation;
- (d) recording in the patient’s record any refusal of the offer mentioned in sub-paragraph (a);
- (e) where—
- (i) the offer mentioned in sub-paragraph (a) is accepted, and
- (ii) in case of a patient who is not a child, the immunisation is to be administered by the contractor or another health care professional,
administering the immunisations and recording the immunisation information in the patient’s record, using codes agreed by NHS England for this purpose;
- (f) where—
- (i) the offer mentioned in sub-paragraph (a) is accepted, and
- (ii) in the case of a patient who is not a child, the immunisation is not to be administered by the contractor or another health care professional,
issuing a prescription form for the purposes of self-administration by the patient.
- (8) For the purposes of paragraph (7)—
- “immunisation information” means—either—the patient’s consent to immunisation, orwhere another person consents to immunisation on behalf of the patient, the name of the person who gave that consent and their relationship to the patient;the batch number, expiry date and title of the vaccine;the date of administration of the vaccine;where two vaccines are administered by injections, in close succession, the route of administration and the injection site of each vaccine;any contraindications to the vaccine; andany adverse reactions to the vaccine.
- (9) For the purposes of paragraphs (2) to (7) “a patient’s record” means the record which is kept in relation to a patient in accordance with regulation 67.
PART 2 — Contractors: conditions and eligibility
Conditions: general
4
- (1) NHS England may only enter into a contract if the conditions specified in regulations 5 and 6 are met.
- (2) Paragraph (1) is subject to the provisions of any scheme made by the Secretary of State under section 300 (transfer schemes) (before its repeal), section 302 (transfer schemes in respect of previously transferred property) and section 303 (power to make consequential provision) of the Health and Social Care Act 2012 .
Conditions relating solely to medical practitioners
5
- (1) Where NHS England enters, or is proposing to enter, into a contract with—
- (a) a medical practitioner, that medical practitioner must be a general medical practitioner;
- (b) two or more persons practising in partnership—
- (i) at least one partner (who must not be a limited partner) must be a general medical practitioner, and
- (ii) any other partner who is a medical practitioner must be—
- (aa) a general medical practitioner, or
- (bb) employed by 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; or
- (c) a company limited by shares—
- (i) at least one share in the company must be both legally and beneficially owned by a general medical practitioner, and
- (ii) any other share or shares in the company that are both legally and beneficially owned by a medical practitioner must be so owned by—
- (aa) a general medical practitioner, or
- (bb) a medical practitioner who is employed by 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) In paragraph (1)(a), (b)(i) and (c)(i) “general medical practitioner” does not include a medical practitioner whose name is included in the General Practitioner Register by virtue of being a medical practitioner to whom paragraph (3), (4) or (5) applies.
- (3) This paragraph applies to a medical practitioner referred to in article 4(3) of the 2010 Order (general practitioners eligible for entry in the General Practitioner Register) who was exempt from the requirement to have the prescribed experience under—
- (a) regulation 5(1)(d) of the National Health Service (Vocational Training for General Medical Practice) Regulations 1997 ;
- (b) regulation 5(1)(d) of the National Health Service (Vocational Training for General Medical Practice) (Scotland) Regulations 1998 ; or
- (c) regulation 5(1)(d) of the Medical Practitioners (Vocational Training) Regulations (Northern Ireland) 1998 .
- (4) This paragraph applies to a medical practitioner who has an acquired right for the purposes of article 6(2) of the 2010 Order (persons with acquired rights) by virtue of—
- (a) having been a restricted services principal; and
- (b) that medical practitioner's name being included, as at 31st December 1994, in—
- (i) a medical list which was, at that date, kept by a Family Health Services Authority , or
- (ii) any corresponding list which was, at that date, kept by a Health Board or by the Northern Ireland Central Services Agency for the Health and Social Services in Northern Ireland.
- (5) This paragraph applies to a medical practitioner who has an acquired right for the purposes of article 6(6) of the 2010 Order (which relates to persons engaged or provided as a deputy or employed as an assistant) because, on at least ten days in the period of four years ending with 31st December 1994, or on at least 40 days in the period of ten years ending with that date, that medical practitioner was—
- (a) engaged as a deputy by, or provided as a deputy to, a medical practitioner whose name was included in—
- (i) the medical list which was, at that date, kept by a Family Health Services Authority, or
- (ii) any corresponding list kept, at that date, by a Health Board or by the Northern Ireland Central Services Agency for the Health and Social Services in Northern Ireland; or
- (b) employed as an assistant (other than as a trainee general practitioner) by such a medical practitioner.
- (6) In paragraph (4)(a), “restricted services principal” means a medical practitioner who provided general medical services limited to child health surveillance, contraceptive services, maternity medical services (except the services mentioned in regulation 3(4)(c) or (d)) or minor surgery.
General condition relating to all contracts
6
- (1) NHS England must not enter into a contract with—
- (a) a medical practitioner to whom paragraph (2) applies; or
- (b) two or more persons practising in partnership, where paragraph (2) applies to any person who is a partner in the partnership; or
- (c) a company limited by shares where paragraph (2) applies to—
- (i) the company,
- (ii) any person both legally and beneficially owning a share in the company, or
- (iii) any director or secretary of the company.
- (2) This paragraph applies if—
- (a) the contractor is the subject of a national disqualification;
- (b) subject to paragraph (3), the contractor is disqualified or suspended (other than by interim suspension order or direction pending an investigation) from practising by any licensing body anywhere in the world;
- (c) the contractor has, within the period of five years before the signing of the contract or commencement of the contract (whichever is the earlier), been dismissed (otherwise than by reason of redundancy) from any employment by a health service body, unless—
- (i) if the contractor was employed as a member of a health care profession at the time of the dismissal, the contractor has not subsequently been employed by that health service body or by another health service body, and
- (ii) the dismissal was the subject of a finding of unfair dismissal by any competent tribunal or a court;
- (d) the contractor has, within the period of five years before the signing of the contract or commencement of the contract (whichever is the earlier), been removed from, or refused admission to, a primary care list by reason of inefficiency, fraud or unsuitability (within the meaning of section 151(2), (3) and (4) of the Act (disqualification of practitioners)), or a performers list held by NHS England by virtue of regulations made under section 91(3) (persons performing primary medical services) of the Act, unless the contractor's name has subsequently been included in such a list;
- (e) the contractor has been convicted in the United Kingdom of murder;
- (f) the contractor has been convicted in the United Kingdom of a criminal offence other than murder committed on or after 14th December 2001 and has been sentenced to a term of imprisonment of longer than six months;
- (g) subject to paragraph (3), the contractor has been convicted outside of the United Kingdom of an offence which would, if committed in England and Wales, constitute murder and—
- (i) the offence was committed on or after 14th December 2001, and
- (ii) the contractor was sentenced to a term of imprisonment of longer than six months;
- (h) the contractor 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 this Act apply), or in Schedule 1 to the Criminal Procedure (Scotland) Act 1995 (offences against children under the age of 17 years to which special provisions apply), committed on or after 1st March 2004;
- (i) the contractor has at any time been included in—
- (i) any barred list within the meaning of section 2 of the Safeguarding Vulnerable Groups Act 2006 (barred lists), or
- (ii) any barred list within the meaning of article 6 of the Safeguarding Vulnerable Groups (Northern Ireland) Order 2007 (barred lists),
unless the contractor was removed from the list either on the grounds that it was not appropriate for the contractor to have been included in it or as the result of a successful appeal;
- (j) the contractor has, within the period of five years before the signing of the contract or commencement of the contract (whichever is the earlier), been removed from the office of charity trustee or trustee for a charity by an order made by the Charity Commission, the Charity Commission for Northern Ireland or the High Court, and that order was made on the grounds of misconduct or mismanagement in the administration of a charity for which the contractor was responsible or to which the contractor was privy, or which was contributed to, or facilitated by, the contractor's conduct;
- (k) the contractor has, within the period of five years before the signing of the contract or commencement of the contract (whichever is the earlier), been removed from being concerned with the management or control of any body in a case where the removal was by virtue of section 34(5)(e) of the Charities and Trustee Investment (Scotland) Act 2005 (powers of Court of Session);
- (l) the contractor—
- (i) has been made bankrupt and has not been discharged from the bankruptcy or the bankruptcy order has not been annulled, or
- (ii) has had sequestration of the contractor's estate awarded and has not been discharged from the sequestration;
- (m) the contractor is the subject of a bankruptcy restrictions order or an interim bankruptcy restrictions order under Schedule 4A to the Insolvency Act 1986 (bankruptcy restrictions order and undertaking), Schedule 2A to the Insolvency (Northern Ireland) Order 1989 (bankruptcy restrictions order and undertaking), or sections 56A to 56K of the Bankruptcy (Scotland) Act 1985 (bankruptcy restrictions order, interim bankruptcy restrictions order and bankruptcy restrictions undertaking), unless the contractor has been discharged from that order or that order has been annulled;
- (n) the contractor—
- (i) is subject to moratorium period under a debt relief order under Part VIIA of the Insolvency Act 1986 (debt relief orders), or
- (ii) is the subject of a debt relief restrictions order or an interim debt relief restrictions order under Schedule 4ZB to that Act (debt relief restrictions orders and undertakings);
- (o) the contractor has made a composition agreement or arrangement with, or granted a trust deed for, the contractor's creditors and the contractor has not been discharged in respect of it;
- (p) the contractor is subject to—
- (i) a disqualification order under section 1 of the Company Directors Disqualification Act 1986 (disqualification orders: general) or a disqualification undertaking under section 1A of that Act (disqualification undertakings: general),
- (ii) a disqualification order or disqualification undertaking under article 3 (disqualification orders: general ) or article 4 (disqualification undertakings: general) of the Company Directors Disqualification (Northern Ireland) Order 2002 , or
- (iii) a disqualification order under section 429(2) of the Insolvency Act 1986 (disabilities on revocation of an administration order against an individual);
- (q) the contractor has had an administrator, administrative receiver or receiver appointed in respect of the contractor;
- (r) the contractor has had an administration order made in respect of the contractor under Schedule B1 to the Insolvency Act 1986 (administration); or
- (s) the contractor is a partnership and—
- (i) a dissolution of the partnership is ordered by any competent court, tribunal or arbitrator, or
- (ii) an event happens that makes it unlawful for the business of the partnership to continue, or for members of the partnership to carry on in partnership.
- (3) Paragraph (2)(b) or, as the case may be, paragraph (2)(g), does not apply to a person where—
- (a) that person—
- (i) has been disqualified or suspended from practising by a licensing body outside of the United Kingdom, or
- (ii) has been convicted outside of the United Kingdom of a criminal offence; and
- (b) NHS England is satisfied that the disqualification, suspension or, as the case may be, the conviction does not make that person unsuitable to be—
- (i) a contractor,
- (ii) a partner, in the case of a contract with two or more persons practising in partnership, or
- (iii) in the case of a company limited by shares—
- (aa) a person who both legally and beneficially owns a share in the company, or
- (bb) a director or secretary of the company.
- (4) For the purposes of paragraph (2)(c)—
- (a) 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; and
- (b) a health service body includes a Strategic Health Authority or a Primary Care Trust which was established before the coming into force of section 33 (abolition of Strategic Health Authorities) or 34 (abolition of Primary Care Trusts) of the Health and Social Care Act 2012 .
- (5) In this regulation, “contractor” includes a person with whom NHS England is proposing to enter into a contract with.
Notice of conditions not being met and reasons
7
- (1) Where NHS England considers that the conditions specified in regulation 5 or 6 for entering into a contract are not met, it must give notice in writing to the person or persons intending to enter into the contract of—
- (a) its view and the reasons for that view; and
- (b) the right of appeal under regulation 8.
- (2) NHS England must also give notice in writing of its view and the reasons for that view to any person who both legally and beneficially owns a share in, or who is a director or secretary of, a company that is given notice under paragraph (1) in any case where its reason for the decision relates to such a person.
Right of appeal
8
A person who has been given a notice by NHS England under regulation 7(1) may appeal to the First-tier Tribunal against the decision of NHS England that the conditions in regulation 5 or 6 are not met.
PART 3 — Pre-contract dispute resolution
Pre-contract disputes
9
- (1) If, in the course of negotiations intending to lead to a contract, the parties to the proposed contract (“the prospective parties”) are unable to agree on a particular term of the contract, either party may refer the dispute to the Secretary of State to consider and determine.
- (2) Where the prospective parties are health service bodies, any dispute which arises in the course of the negotiation of the proposed contract may be referred to the Secretary of State for determination under section 9 of the Act (NHS contracts).
- (3) Any dispute referred to the Secretary of State in accordance with paragraph (1), or to which section 9 of the Act applies by virtue of paragraph (2), must be considered and determined in accordance with the provisions of regulations 83(3) to (15) and 84(1) and, where applicable, paragraph (4) of this regulation.
- (4) Where the Secretary of State determines a dispute referred under paragraph (1), the determination—
- (a) may specify terms to be included in the proposed contract;
- (b) may require NHS England to proceed with the proposed contract, but may not require the intended contractor to proceed with the proposed contract; and
- (c) is binding upon the prospective parties.
PART 4 — Health service body status
Health service body status: election
10
- (1) A person who proposes to enter into a contract with NHS England (a “proposed contractor”) may elect, by giving notice in writing to NHS England prior to entering into the contract, to be regarded as a health service body for the purposes of section 9 of the Act (NHS contracts).
- (2) An election made by a proposed contractor under paragraph (1) has effect from the date on which the contract is entered into.
- (3) If, by virtue of paragraph (1), a proposed contractor elects to be regarded as a health service body, the nature of, or any rights or liabilities under, any other contract previously entered into by that proposed contractor with a health service body before the date of that election remains unaffected.
- (4) Paragraph (5) applies where—
- (a) a contractor who is an individual medical practitioner enters, or two or more persons practising in a partnership enter, into a contract with NHS England; and
- (b) that contractor is to be regarded as a health service body in accordance with paragraph (1).
- (5) Subject to regulation 11, the contractor is to be regarded as a health service body for the purposes of section 9 of the Act (NHS contracts) for as long as the contract continues irrespective of any change in the—
- (a) partners in the partnership;
- (b) status of the contractor from that of an individual medical practitioner to that of a partnership; or
- (c) status of the contractor from that of a partnership to that of an individual medical practitioner.
Health service body status: variation of contracts
11
- (1) A contractor may at any time request in writing a variation of the contract to include in, or remove from, the contract provision to the effect that the contract is an NHS contract and, if it does so—
- (a) NHS England must agree to the variation; and
- (b) the procedure specified in regulation 29 and Part 8 of Schedule 3 for the variation of contracts applies.
- (2) If, by virtue of a request under paragraph (1), the contractor is to be regarded as a health service body—
- (a) any rights or liabilities under any other contract with a health service body entered into by the contractor before the date on which the contractor is so regarded remain unaffected; and
- (b) the contractor is to be regarded as a health service body for the purposes of section 9 of the Act (NHS contracts) from the date on which the variation takes effect in accordance with regulation 29 and Part 8 of Schedule 3.
- (3) Where NHS England agrees to the variation of the contract, the contractor is to be regarded or, subject to regulation 12, is to cease to be regarded, as a health service body for the purposes of section 9 of the Act (NHS contracts) from the date on which the variation takes effect in accordance with regulation 29 and Part 8 of Schedule 3.
Cessation of health service body status
12
- (1) A contractor ceases to be regarded as a health service body for the purposes of section 9 of the Act (NHS contracts) if the contract terminates.
- (2) Where, by virtue of paragraph (1), a contractor ceases to be regarded as a health service body in relation to a contract (“the relevant contract”), the contractor is to continue to be regarded as a health service body for the purposes of any other NHS contract to which it became a party between the date on which it entered into the relevant contract and the date on which it ceased to be regarded as a health service body for the purposes of that contract (but it ceases to be a health service body for the purposes of such other NHS contract on the termination of that contract).
- (3) Where—
- (a) a contractor ceases to be regarded as a health service body in relation to a contract by reason of a variation of the contract by virtue of regulation 11(1); and
- (b) the contractor or NHS England —
- (i) has referred any matter to the NHS dispute resolution procedure before it ceases to be a health service body, or
- (ii) refers any matter to the NHS dispute resolution procedure, in accordance with regulation 82, after it ceases to be a health service body,
the contractor is to continue to be regarded as a health service body (and accordingly the contract is to continue to be regarded as an NHS contract) for the purposes of the consideration and determination of the dispute.
- (4) Where a contractor ceases to be regarded as a health service body by virtue of regulation 11(1) but continues to be regarded as a health service body for the purposes of the NHS dispute resolution procedure where that procedure was commenced—
- (a) before the termination of the contract; or
- (b) after the termination of the contract (whether in connection with or arising out of the termination of the contract or otherwise),
the contractor ceases to be regarded as a health service body for those purposes on the conclusion of that procedure.
PART 5 — Contracts: required terms
Parties to the contract
13
A contract must specify—
- (a) the names of the parties to the contract;
- (b) in the case of each party to the contract, the address to which official correspondence and notices should be sent; and
- (c) in the case of a party to the contract which is a partnership—
- (i) the names of the partners,
- (ii) whether or not the partnership is a limited partnership, and
- (iii) in the case of a limited partnership, the status of each partner as a general or a limited partner.
Health service contract
14
If, by virtue of regulation 10 or 11, a contractor is to be regarded as a health service body, the contract must state that it is an NHS contract.
Contracts with individuals practising in partnership
15
Where a contract is with two or more individuals practising in partnership—
- (a) the contract is to be treated as made with the partnership as it is from time to time constituted, and the contract must make specific provision to this effect; and
- (b) the terms of the contract must require the contractor to ensure that any person who becomes a partner in the partnership after the contract has come into force is automatically bound by the contract whether by virtue of a partnership deed or otherwise.
Duration
16
- (1) Except as provided in paragraph (2), a contract must provide for it to subsist until it is terminated in accordance with the terms of the contract or by virtue of the operation of any other legal provision.
- (2) NHS England may enter into a temporary contract for a period not exceeding 12 months for the provision of services to the former patients of a contractor following the termination of that contractor's contract.
- (3) Either party to a prospective contract to which paragraph (2) applies may, if it so desires, invite the Local Medical Committee (if any) for the area in which it is intended that primary medical services are to be provided by the prospective contractor, to participate in the negotiations intending to lead to such a contract.
Essential services
17
- (1) Subject to paragraph (2), for the purposes of section 85(1) of the Act (requirement to provide certain medical services), the services which must be provided under a contract (“essential services”) are the services described in paragraphs (4), (6), (7) and (9).
- (2) Essential services are not required to be provided by the contractor during any period in respect of which the Care Quality Commission has suspended the contractor as a service provider under section 18 of the Health and Social Care Act 2008 (suspension of registration).
- (3) Subject to regulation 20(2)(b) and (c), a contractor must provide the services described in paragraphs (4) and (6) throughout the core hours.
- (4) The services described in this paragraph are services required for the management of a contractor's registered patients and temporary residents who are, or believe themselves to be—
- (a) ill, with conditions from which recovery is generally expected;
- (b) terminally ill; or
- (c) suffering from chronic disease,
which are delivered in the manner determined by the contractor's practice in discussion with the patient.
- (5) For the purposes of paragraph (4)—
- “disease” means a disease included in the list of three-character categories contained in the tenth revision of the International Statistical Classification of Diseases and Related Health Problems ; and
- “management” includes—offering consultation and, where appropriate, physical examination for the purposes of identifying the need, if any, for treatment or further investigation; andmaking available such treatment or further investigation as is necessary and appropriate, including the referral of the patient for other services under the Act and liaison with other health care professionals involved in the patient's treatment and care.
- (6) The services described in this paragraph are the provision of appropriate ongoing treatment and care to all of the contractor’s registered patients and temporary residents taking into account their specific needs including—
- (a) advice in connection with the patient’s health and relevant health promotion advice; and
- (b) the referral of a patient for services under the Act,
together with the provision of the services specified in paragraph (6A).
- (6A) The services mentioned in paragraph (6) are—
- (a) cervical screening services;
- (b) child health surveillance services;
- (c) contraceptive services;
- (d) maternity medical services; and
- (e) vaccine and immunisation services.
- (7) A contractor must provide primary medical services required in core hours for the immediately necessary treatment of any person to whom the contractor has been requested to provide treatment owing to an accident or emergency at any place in the contractor's practice area.
- (8) In paragraph (7), “emergency” includes any medical emergency whether or not related to services provided under the contract.
- (9) A contractor must provide primary medical services required in core hours for the immediately necessary treatment of any person to whom paragraph (10) applies who requests such treatment for the period specified in paragraph (11).
- (10) This paragraph applies to a person if—
- (a) that person's application for inclusion in the contractor's list of patients has been refused in accordance with paragraph 21, 32D or 32F of Schedule 3, and that person is not registered with another provider of essential services (or their equivalent);
- (b) that person's application for acceptance as a temporary resident has been refused under paragraph 21, 32E or 32G of Schedule 3; or
- (c) that person is present in the contractor's practice area for a period of less than 24 hours.
- (11) The period specified in this paragraph is, in the case of a person to whom—
- (a) paragraph (10)(a) applies, 14 days beginning with the relevant date or until that person has been subsequently registered elsewhere for the provision of essential services (or their equivalent), whichever occurs first;
- (b) paragraph (10)(b) applies, 14 days beginning with the relevant date or until that person has been subsequently accepted elsewhere as a temporary resident, whichever occurs first; or
- (c) paragraph (10)(c) applies, 24 hours or such shorter period as the person is present in the contractor's practice area.
- (11A) For the purposes of paragraph (11) “relevant date”—
- (a) if the person’s application is refused in accordance with paragraph 32D, 32E, 32F or 32G of Schedule 3, means the later of—
- (i) the date on which the application is refused, and
- (ii) the date on which the person returns to the United Kingdom;
- (b) if the person’s application is refused in accordance with paragraph 21 of Schedule 3, means the date on which the application is refused.
- (12) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (13) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (14) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (15) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Out of hours services
18
- (1) Subject to paragraphs (2) and (3), a contract must provide for the provision by a contractor of out of hours services.
- (2) A contractor whose contract includes the provision of out of hours services—
- (a) is only required to provide out of hours services to a patient if, in the contractor's reasonable opinion having regard to the patient's medical condition, it would not be reasonable in all the circumstances for the patient to wait to obtain those services; and
- (b) must, in the provision of out of hours services—
- (i) meet the quality requirements set out in the Integrated Urgent Care Key Performance Indicators published on 25th June 2018, and
- (ii) comply with any requests for information which it receives from, or on behalf of, NHS England about the provision by the contractor of out of hours services to its registered patients in such manner, and before the end of such period, as is specified in the request.
- (3) Where a contractor is not required to provide out of hours services under a contract or, by virtue of Part 6, has opted out of the provision of such services under the contract, the contractor must—
- (a) monitor the quality of the out of hours services which are offered or provided to the contractor's registered patients having regard to the Integrated Urgent Care Key Performance Indicators referred to in paragraph (2)(b), and record, and act appropriately in relation to, any concerns arising;
- (b) record any patient feedback received, including any complaints;
- (c) report to NHS England , either at the request of NHS England or otherwise, any concerns arising about the quality of the out of hours services which are offered or provided to patients having regard to—
- (i) any patient feedback received, including any complaints, and
- (ii) the quality requirements set out in the Integrated Urgent Care Key Performance Indicators referred to in sub-paragraph (2)(b).
Additional services
19
- (1) Subject to Part 6, a contract may provide for the provision by a contractor of minor surgery.
- (2) A contract which includes minor surgery must contain a term which requires the contractor to provide such facilities as are necessary to enable the contractor to properly perform that service.
Services: general
20
- (1) A contract must specify—
- (a) the services to be provided;
- (b) subject to paragraph (4), the address of each of the premises to be used by the contractor or any sub-contractor for the provision of such services;
- (c) the persons to whom such services are to be provided;
- (d) the area (the contractor's “practice area”) as respects which persons resident in it are, subject to any other terms of the contract relating to patient registration, entitled to—
- (i) register with the contractor, or
- (ii) seek acceptance by the contractor as a temporary resident; and
- (e) whether, at the date on which the contract comes into force, the contractor's list of patients is open or closed.
- (2) A contract must also—
- (a) state the period (if any) for which the services are to be provided except where those services are—
- (i) essential services,
- (ii) minor surgery funded under the global sum, and
- (iii) out of hours services;
- (b) contain a term which requires the contractor to provide—
- (i) essential services, and
- (ii) minor surgery funded under the global sum,
at such times, within core hours, as are appropriate to meet the reasonable needs of patients; and
- (c) contain a term which requires the contractor to have in place arrangements for its patients to access essential services and minor surgery funded under the global sum throughout the core hours in case of emergency.
- (3) A contract—
- (a) may also specify an area, other than the contractor's practice area, which is to be known as the outer-boundary area as respects which a patient who—
- (i) moves into that outer-boundary area to reside, and
- (ii) would like to remain on the contractor's list of patients,
may remain on that list, if the contractor so agrees, notwithstanding that the patient no longer resides in the contractor's practice area; and
- (b) which specifies an outer-boundary area must also specify that, where a patient remains on the contractor's list of patients as a consequence of sub-paragraph (a), the outer boundary area is to be treated as part of the contractor's practice area for the purposes of the application of any other terms and conditions of the contract in respect of that patient.
- (4) The premises referred to in paragraph (1)(b) do not include—
- (a) the homes of patients; ...
- (b) any other premises where services are provided on an emergency basis ; or
- (c) premises where services are provided under regulation 20A (services: remote provision outside practice premises).
- (5) Where, on the date on which the contract is signed, NHS England is not satisfied that all or any of the premises specified in accordance with paragraph (1)(b) meet the requirements set out in paragraph 1 of Schedule 3, the contract must include a plan, drawn up jointly by NHS England and the contractor, which specifies—
- (a) the steps to be taken by the contractor to bring the premises up to the relevant standard;
- (b) any financial support that may be available from NHS England; and
- (c) the timescale on which the steps referred to in sub-paragraph (a) are to be taken.
- (6) A contract must specify that where the contractor proposes to provide private services in addition to primary medical services, to persons other than its patients the provision must take place—
- (a) outside of the hours the contractor has agreed to provide primary medical services; and
- (b) on no part of any practice premises in respect of which NHS England makes any payments pursuant to the National Health Service (General Medical Services - Premises Costs) Directions 2013 save where the private services are those specified in regulation 24(2B).
Membership of a CCG
21
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Certificates
22
- (1) Subject to paragraphs (2) and (3), a contract must contain a term which has the effect of requiring the contractor to issue any medical certificate of a description prescribed in column 1 of Schedule 2 under, or for the purposes of, the enactments specified in relation to that certificate in column 2 of that Schedule if that certificate is reasonably required under or for the purposes of the enactments specified in relation to that certificate.
- (2) A certificate referred to in paragraph (1) must be issued free of charge to a patient or to a patient's personal representatives.
- (3) A certificate must not be issued where, for the condition to which the certificate relates, the patient is—
- (a) being attended by a medical practitioner who is not—
- (i) engaged or employed by the contractor,
- (ii) in the case of a contract with two or more persons practising in a partnership, one of those persons, or
- (iii) in the case of a contract with a company limited by shares, one of the persons legally or beneficially owning shares in that company; or
- (b) not being treated by or under the supervision of a health care professional.
- (4) The exception in paragraph (3)(a) does not apply where the certificate is issued in accordance with regulation 2(1) of the Social Security (Medical Evidence) Regulations 1976 (evidence of incapacity for work, limited capability for work and confinement) or regulation 2(1) of the Statutory Sick Pay (Medical Evidence) Regulations 1985 (medical information).
Finance
23
- (1) The contract must contain a term which has the effect of requiring payments under the contract to be made promptly and in accordance with—
- (a) the terms of the contract; and
- (b) any other conditions relating to payment contained in directions given by the Secretary of State under section 87 of the Act (GMS contracts: payments) .
- (2) The contract must contain a term to the effect that where, in accordance with directions given by the Secretary of State under section 87 (GMS contracts: payments) or section 98A of the Act (exercise of functions), NHS England is required to make a payment to a contractor under a contract but subject to conditions, those conditions must be a term of the contract.
- (3) The obligation referred to in paragraph (1) is subject to any right that NHS England may have to set off against an amount payable to the contractor under the contract any amount that—
- (a) is owed by the contractor to NHS England under the contract; or
- (b) NHS England may withhold from the contractor in accordance with the terms of the contract or any other applicable provisions contained in directions given by the Secretary of State under section 87 of the Act (GMS contracts: payments).
Fees and charges
24
- (1) The contract 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 must not, either itself or through any other person, demand or accept from any of its patients a fee or other remuneration for its own benefit or for the benefit of another person in respect of—
- (a) the provision of any treatment whether under the contract or otherwise; or
- (b) a prescription or repeatable prescription for any drug, medicine or appliance,
except in the circumstances set out in regulation 25.
- (2A) The contractor must not, either itself or through any other person, demand or accept from any of its patients a fee or other remuneration for its own benefit or for the benefit of another person, for the completion, in relation to the patient’s mental health, of—
- (a) a mental health evidence form; or
- (b) any examination of the patient or of the patient’s medical record in order to complete the form,
the purpose of which is to assist creditors in deciding what action to take where the debtor has a mental health problem.
- (2B) The contractor must not, either itself or through any other person, demand or accept from anyone who is not a patient of the contractor, a fee or other remuneration for its own benefit or for the benefit of another person, for either of the following services provided on practice premises to which regulation 20(6)(b) applies, unless those services are provided outside of core hours—
- (a) for treatment consisting of an immunisation for which the contractor receives no remuneration from NHS England when provided to its patients and which is requested in connection with travel abroad; or
- (b) for prescribing or providing drugs or medicines for malaria chemoprophylaxis.
- (3) Subject to paragraph (4), where—
- (a) a person—
- (i) applies to a contractor for the provision of essential services, and
- (ii) claims to be on that contractor's list of patients, and
- (iii) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- (b) the contractor has reasonable doubts about that person's claim,
the contractor must give any necessary treatment to that person and may demand and accept from that person a reasonable fee in accordance with regulation 25(e).
- (4) Where—
- (a) a person from whom the contractor has received a fee under regulation 25(e) applies to NHS England for a refund within 14 days from the date of payment of the fee (or within such longer period not exceeding one month as NHS England may allow if it is satisfied that the failure to apply within 14 days was reasonable); and
- (b) NHS England is satisfied that that person was on the contractor's list of patients when the treatment was given,
NHS England may recover the amount of the fee from the contractor, by deduction from the contractor's remuneration or otherwise, and must pay the amount recovered to the person who paid the fee.
Circumstances in which fees and charges may be made
25
The contractor may demand or accept (directly or indirectly) a fee or other remuneration—
- (a) from a statutory body for services rendered for the purposes of that body's statutory functions;
- (b) from a body, employer or school for—
- (i) a routine medical examination of persons for whose welfare the body, employer or school is responsible, or
- (ii) an examination of such persons for the purpose of advising the body, employer or school of any administration action that they might take;
- (c) for treatment which is not primary medical services or is otherwise required under the contract and which is given—
- (i) at accommodation made available in accordance with the provisions of paragraph 11 of Schedule 6 to the Act (accommodation and services for private patients), or
- (ii) in a registered nursing home which is not providing services under the 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 seven days of giving the treatment, the contractor or the person giving the treatment supplies NHS England, on a form provided by NHS England for that purpose, with such information as NHS England may require;
- (d) under section 158 of the Road Traffic Act 1988 (payment for emergency treatment of traffic casualties);
- (e) when the contractor treats a patient under regulation 24(3), in which case the contractor is entitled to demand and accept a reasonable fee (recoverable in certain circumstances under regulation 24(4)) for any treatment given, if the contractor gives the patient a receipt;
- (f) for attending and examining (but not otherwise treating) a patient—
- (i) at a police station, at the patient's request, in connection with possible criminal proceedings against the patient,
- (ii) for the purpose of creating a medical report or certificate, at the request of a commercial, educational or not for profit organisation,
- (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 NHS England 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 their possession solely in anticipation of the onset of an ailment or occurrence of an injury while that patient is outside of the United Kingdom but for which that patient is not requiring treatment when the drug, medicine or appliance 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 the patient is fit to travel;
- (j) for testing the sight of a person to whom none of paragraphs (a) to (e) of section 115(2) of the Act (primary ophthalmic services) applies (including by reason of regulations made under section 115(7) of the Act) ;
- (k) where the contractor is authorised or required in accordance with arrangements made with NHS England under section 126 of the Act (arrangements for pharmaceutical services) and in accordance with regulations made under section 129 of the Act (regulations as to pharmaceutical services) to provide drugs, medicines or appliances to a patient and provides for that patient, otherwise than by way of dispensing services, any Scheduled drug; ...
- (l) for prescribing or providing drugs or medicines for malaria chemoprophylaxis.
- (m) for responding to an exemption confirmation request as defined in regulation 22A(2)(a), if that request is not one which the contractor is required to respond to in accordance with regulation 22A.
Patient participation
26
- (1) The contractor must establish and maintain a group known as a “Patient Participation Group” comprising some of its registered patients for the purposes of—
- (a) obtaining the views of patients who have attended the contractor's practice about the services delivered by the contractor; and
- (b) enabling the contractor to obtain feedback from its registered patients about those services.
- (2) The contractor is not required to establish a Patient Participation Group if such a group has already been established by the contractor in accordance with any directions about enhanced services which were given by the Secretary of State under section 98A of the 2006 Act (exercise of functions) before 1st April 2015.
- (3) The contractor must make reasonable efforts during each financial year to review the membership of its Patient Participation Group in order to ensure that the Group is representative of its registered patients.
- (4) The contractor must—
- (a) engage with its Patient Participation Group, at such frequent intervals throughout the financial year as the contractor must agree with that Group, with a view to obtaining feedback from the contractor's registered patients, in an appropriate and accessible manner which is designed to encourage patient participation, about the services delivered by the contractor; and
- (b) review any feedback received about the services delivered by the contractor, whether by virtue of sub-paragraph (a) or otherwise, with its Patient Participation Group with a view to agreeing with that Group the improvements (if any) which are to be made to those services.
- (5) The contractor must make reasonable efforts to implement such improvements to the services delivered by the contractor as are agreed between the contractor and its Patient Participation Group.
Publication of earnings information
27
- (1) The contractor must publish each year on its practice website or online practice profile the information specified in paragraph (2).
- (2) The information specified in this paragraph is—
- (a) the mean net earnings in respect of the previous financial year of—
- (i) every general medical practitioners who was a party to the contract for a period of at least six months during that financial year, and
- (ii) every general medical practitioners who was employed or engaged by the contractor to provide services under the contract in the contractor's practice, whether on a full- time or a part-time basis, for a period of at least six months during that financial year; and
- (b) the—
- (i) total number of any general medical practitioners to whom the earnings information referred to in sub-paragraph (a) relates, and
- (ii) (where applicable) the number of those practitioners who were employed or engaged by the contractor to provide services under the contract in the contractor's practice whether on a full-time or a part-time basis, for a period of at least six months during the financial year to which that information relates.
- (3) The information specified in paragraph (2) must be—
- (a) published by the contractor before the end of the financial year following the financial year to which that information relates; and
- (b) made available by the contactor in hard copy form on request.
- (4) For the purposes of this regulation, mean net earnings are to be calculated by reference to the earnings of a general medical practitioner that, in the opinion of NHS England, are attributable to the performance or provision by the practitioner under the contract of primary medical services, after having disregarded any expenses properly incurred in the course of performing or providing those services.
Sub-contracting
28
A contract must contain terms which prevent a contractor from sub-contracting any of its obligations to provide clinical services under the contract except in the circumstances provided for by Part 5 of Schedule 3.
Variation of contracts
29
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