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

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• (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

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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);