These Regulations may be cited as F24the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 and, subject to paragraphs (2) to (4), come into force on 1st April 2013.

Part 8 of these Regulations, insofar as the provisions of that Part are made under section 75 of the 2012 Act, comes into force immediately after that section comes fully into force M1.

Part 11 of these Regulations (financial duties of a relevant body in relation to administration) comes into force immediately after sections 24 and 27 of the 2012 Act come fully into force M2.

In these Regulations—

• “1983 Act” means the Mental Health Act 1983;

• “the 2006 Act” means the National Health Service Act 2006;

• “the 2012 Act” means the Health and Social Care Act 2012;

• “armed forces” means the regular forces and the reserved forces within the meaning of the Armed Forces Act 2006 M3;

• “the Board” means the National Health Service Commissioning Board M4;

• “CCG” means clinical commissioning group M5;

• “commissioning contract” means a contract, other than a primary care contract, entered into by a relevant body in the exercise of its commissioning functions;

• “commissioning functions” means the functions of a relevant body in arranging for the provision of services as part of the health service, but it does not include, in relation to the Board, its functions in relation to services provided under a primary care contract;

• “consultant” means a person who has been appointed to a medical consultant post with a health service provider;

• “general dental practitioner” means a person whose name is included in the register maintained by the General Dental Council under section 14 of the Dentists Act 1984 M6;

• “general medical practitioner” means a person registered in the General Practitioner Register held by the General Medical Council under section 34C of the Medical Act 1983 M7;

• “health care professional” means a member of a profession regulated by a body mentioned in section 25(3) of the National Health Service Reform and Health Care Professions Act 2002 M8;

• “health care services” means one or more services consisting of the provision of treatment for the purposes of the health service;

• “health service provider” means a person, other than a relevant body, who has entered into a commissioning contract;

• “immigration removal centre” means a removal centre within the meaning of section 147 of the Immigration and Asylum Act 1999 M9;

• “maternity services” includes all services relating to female patients from the start of the pregnancy to 6 weeks after the birth other than—

  1. a

     the treatment of any medical condition unrelated to pregnancy,

  2. b

     the treatment of any medical condition which does not usually occur in the ordinary course of pregnancy, or

  3. c

     services relating to the termination of pregnancy in accordance with the Abortion Act 1967 M10;

• “mental health services” means services provided to patients in relation to a disorder or disability of the mind;

• “optometrist” means a registered dispensing optician or a registered optometrist within the meaning of the Opticians Act 1989 M11;

• “patient” means any person who is receiving treatment provided as part of the health service;

• “primary care contract” means a contract or other arrangement between the Board and a provider of primary care services to provide one or more primary care services;

• “primary care services” means services provided as part of the health service pursuant to arrangements made by the Board under Parts 4 to 7 of the 2006 Act;

• “relevant body” means a CCG or the Board;

• “relevant date” means 1st April 2013;

• “secure children's home” means a children's home used for the purpose of restricting liberty and approved for that purpose in respect of which a person is registered under Part 2 of the Care Standards Act 2000 M12;

• “secure training centre” means a place in which offenders subject to detention and training orders under section 100 of the Powers of Criminal Courts (Sentencing) Act 2000 (offenders under 18: detention and training orders) M13 may be detained and given training and education and prepared for their release;

• “treatment”, except in Part 9 (waiting times), means an intervention that is intended to manage a person's disease, condition or injury and includes prevention, examination and diagnosis;

• “young offender institution” means a place for the detention of offenders sentenced to detention in a young offender institution or to custody for life.

Subject to paragraphs (2) to (4), for the purposes of sections 3 and 3A of the 2006 Act (which relate respectively to a CCG's duty to commission services and its power to do so), a CCG has responsibility for the persons listed in paragraph 2 of Schedule 1 (in addition to those mentioned in section 3(1A) of that Act).

In the case of a person listed in paragraph 2(a), (b), (d), (e) or (f) of Schedule 1, a CCG has responsibility only in relation to the provision of accommodation or services specified in the sub-paragraph of paragraph 2 which relates to that person.

The responsibility for a person listed in paragraph 2(c), (g), (h), (i) or (j) of Schedule 1, does not apply in relation to the provision of ambulance services or accident and emergency services, whether provided at a hospital accident and emergency department, a minor injuries unit, a walk-in centre or elsewhere (but excluding any services provided after the person has been accepted as an in-patient, or at an out-patient appointment).

The arrangements to be made by the Board under paragraph (2)(b) in respect of a person referred to in paragraph (1)(a) must include the provision of any infertility treatment to that person and to that person's partner.

In paragraph (1)(b), “family”, in relation to a person to whom this regulation applies, means that person's immediate family registered for primary care services with Defence Medical Services.

For the purposes of paragraph (6)(b), a relationship is not an exclusive relationship if one or both of the parties is a party to another relationship which is, or could be considered to be, a substantial and exclusive relationship having regard to the provisions of this regulation.

The Board must arrange, to such extent as it considers necessary to meet all reasonable requirements, for the provision as part of the health service of infertility treatment to a person to whom this regulation applies and to that person's partner.

For the purposes of this regulation and regulation 9, “partner” is to be construed in accordance with regulation 7(6) to (9).

Where infertility treatment is provided by the Board under paragraph (1) to the named partner of a person referred to in regulation 8(1), that treatment must be provided at the same facility at which specialist sperm retrieval took place in relation to that person and at which that person's extracted sperm has been stored.

In this regulation, “court” means any court in which criminal proceedings against a person are heard.

A relevant contract in relation to transferring services is not terminated or modified by virtue of the omission of those transferring services from Schedule 4 with effect from the transfer date and continues in force as it did immediately before the transfer date.

The Board retains the duty under regulations 7(2)(c), 10(1)(c) and 11 which it held in relation to those transferring services immediately before the transfer date for so long as a relevant contract for the provision of those services continues to have effect in relation to those transferring services but only to the extent of the provision which is made in that relevant contract for such services.

This regulation applies to services provided by an Independent Sector Treatment Centre pursuant to the arrangements specified in paragraph (2).

The Board must arrange, to such extent as it considers necessary to meet all reasonable requirements, for the provision as part of the health service of the services to which each of the agreements specified in paragraph (2)(a) to (f) relates for the period beginning on 1st April 2013 and, in the case of each respective agreement, ending on the date on which that agreement comes to an end.

In this regulation—

• “assessment and minor elective care services” means services related to the assessment, screening and planned care or treatment of minor medical conditions;

• “diagnostic services” includes imaging services (such as MRI, CT, Ultrasound, Xray, Dexa Scan), physiological measurement, audiology, endoscopies, including direct access diagnostic services from primary care and other ancillary services needed to support the delivery of these services; and

• “elective services” means clinical care services including Final Finished Consultant Episodes relating to, for example, trauma and orthopaedic surgery, general surgery, ear nose and throat, oral surgery, urology, gynaecology, plastic surgery, ophthalmology, hepatobiliary and pancreatic surgery, colorectal surgery, vascular surgery, gastroenterology, respiratory medicine, endocrinology, rheumatology, pain management and dermatology.

The Board must arrange, to such extent as it considers necessary to meet all reasonable requirements, for the provision as part of the health service of specialised clinical risk assessment and management services for people with mental health problems who may present a risk to prominent people or locations.

The duty imposed by subsection (2) of section 117 of the 1983 Act on a CCG M17 (CCG A) to arrange for the provision of after-care services for a person (P) to whom section 117 applies is to be imposed instead on another CCG (CCG B) in the circumstances below.

The duty imposed by subsection (2) of section 117 of the 1983 Act on a CCG to arrange for the provision of after-care services for a person (P) to whom section 117 of the 1983 Act applies is to be imposed instead on the Board in the circumstances below.

These circumstances are where P is receiving an after-care service under section 117 which, if it were being provided under the 2006 Act, would be a service whose provision the Board had a duty to arrange.

In this regulation—

• “appropriate apology” means a sincere expression of sorrow or regret, given in writing, for the harm that has resulted from a patient safety incident;

• F37“LETB” means a local education and training board appointed by Health Education England under section 103 of the Care Act 2014;

• “patient safety incident” means an unintended or unexpected incident that occurs in respect of a patient, during and as a result of the provision of health care services, that could have led to, or did lead to, harm to that patient;

• “relevant person” means the patient in respect of whom the patient safety incident occurred, or someone lawfully acting on that patient's behalf;

• “relevant information”, in relation to a patient safety incident, means written details of—

  1. a

     the patient safety incident,

  2. b

     any investigation that has been carried out into that incident, and any causes of that incident, or other findings, that have been identified as a result of such an investigation, and

  3. c

     any steps that have been taken to prevent the recurrence of such an incident.

The Board may draft model commissioning contracts which reflect the terms and conditions it has drafted pursuant to paragraph (1).

A relevant body must incorporate the terms and conditions drafted by virtue of paragraph (1)(a) in commissioning contracts entered into by it.

The Board may require CCGs to incorporate the terms and conditions it has drafted pursuant to paragraph (1)(b) in commissioning contracts that a CCG enters into.

If a CCG is required by the Board to incorporate terms and conditions pursuant to paragraph (4), it must do so.

The requirements in regulations 16 and 17 apply in relation to commissioning contracts entered into on or after 1st February 2013.

Consultation undertaken before the coming into force of this Part is as effective for the purposes of regulation 18 as consultation undertaken after the coming into force of this Part.

In this Part—

• “2008 Act” means the Health and Social Care Act 2008 M22;

• “Fast Track Pathway Tool” means the Fast Track Pathway Tool for NHS Continuing Healthcare issued by the Secretary of State and dated 28th November 2012 M23;

• F25“flat rate payment” except in regulation 29(1), means a payment of F43£112 per week;

• F26“high band payment” except in regulation 30(1), means a payment of F44£154.14 per week;

• “low band payment” means a payment made at the low band rate following a RNCC determination;

• “medium band payment” means a payment made at the medium band rate following a RNCC determination;

• “National Framework” means the National Framework for NHS Continuing Healthcare and NHS-funded Nursing Care issued by the Secretary of State and dated 28th November 2012 M24;

• “NHS Continuing Healthcare” means a package of care arranged and funded solely by the health service in England for a person aged 18 or over to meet physical or mental health needs which have arisen as a result of disability, accident or illness;

• “nursing care” means nursing care by a registered nurse and “nursing care by a registered nurse” has the same meaning as in section 49(2) of the Health and Social Care Act 2001 M25;

• “old Guidance” means the documents entitled “Guidance on Free Nursing Care in Nursing Homes” dated 25th September 2001 M26 and “NHS Funded Nursing Care Practice Guidance and Workbook (August 2001)” dated 5th September 2001 M27, as supplemented by “NHS Continuing Health Care: Action following the Grogan Judgement” dated 3rd March 2006 M28;

• “registered manager” means, in respect of relevant premises, a person registered with the Care Quality Commission under Chapter 2 of Part 1 of the 2008 Act as a manager in respect of the regulated activity carried on at those premises;

• “registered person” means, in respect of relevant premises, a person who is a service provider or registered manager in respect of those premises;

• “regulated activity” means the activity of providing residential accommodation, together with personal or nursing care, specified in paragraph 2 of Schedule 1 to the Health and Social Care Act 2008 (Regulated Activities) Regulations 2010 M29;

• “relevant premises” means premises where regulated activity is carried on and for which there is a registered person;

• “relevant social services authority” means the social services authority appearing to a relevant body to be the authority in whose area a patient is ordinarily resident;

• “RNCC determination” means a determination as to the Registered Nursing Contribution to Care taken in respect of a person in accordance with the National Health Service (Nursing Care in Residential Accommodation) (England) Directions 2001 M30;

• “service provider” means, in respect of relevant premises, a person registered with the Care Quality Commission under Chapter 2 of Part 1 of the 2008 Act as a service provider in respect of the regulated activity carried on at those premises;

• “social services authority” means a local authority for the purposes of the Local Authority Social Services Act 1970 M31 and the Council of the Isles of Scilly;

• “social services authority area” means an area for which a local social services authority is responsible.

For the purposes of this Part, an assessment in relation to a person's need for nursing care means such assessment as the relevant body considers appropriate in the circumstances in order to determine whether the person has a need for nursing care.

In exercising its functions under or by virtue of sections 3, 3A or 3B of the 2006 Act, insofar as they relate to NHS Continuing Healthcare, a relevant body must comply with paragraphs (2) to (11).

If a relevant body decides that a person has a primary health need in accordance with paragraph (5)(b), it must also decide that that person is eligible for NHS Continuing Healthcare.

Paragraph (7B) applies where an NHS trust makes a recommendation to a relevant body that it should decide that a person is eligible for NHS Continuing Healthcare pursuant to direction 2(6) of the Delayed Discharges Directions.

Where this paragraph applies, the relevant body may decide that the person is eligible for NHS Continuing Healthcare in reliance on the recommendation of the NHS trust, and if it does so, paragraphs (2) to (6) do not apply.

In carrying out its duties under this regulation, a relevant body must have regard to the National Framework.

In this regulation—

• “appropriate clinician” means a person who is—

  1. a

     responsible for the diagnosis, treatment or care of the person under the 2006 Act in respect of whom F12the Fast Track Pathway Tool is being completed, and

  2. b

     a registered nurse M34 or a registered medical practitioner M35;

• F13“Delayed Discharges Directions” means the Delayed Discharges (Continuing Care) Directions 2013;

• “healthcare profession” means a profession which is concerned (wholly or partly) with the physical or mental health of individuals F14(whether or not a person engaged in that profession is regulated by, or by virtue of, any enactment);

• “multi-disciplinary team” means a team consisting of at least—

  1. a

     two professionals who are from different healthcare professions, or

  2. b

     one professional who is from a healthcare profession and one person who is responsible for assessing persons for community care services under F38section 9 of the Care Act 2014 (assessment of an adult’s needs for care and support).

Where an application for a review under paragraph (3) relates to the procedure followed by, or a decision taken by, the Board, it must ensure that in organising a review of that decision, it makes appropriate arrangements as regards the manner in which it organises such a review so as to avoid any conflict of interest.

The procedure and operation of the review panel are to be a matter for the chair of the review panel, having regard to the National Framework.

The Board must, as soon as reasonably practicable, give notice in writing of the review decision and the reasons for it to the applicant and, where the relevant body is a CCG, to the CCG whose decision has been the subject of review.

A relevant body must, unless it determines in accordance with paragraph (9) that there are exceptional reasons not to do so, implement the decision of the review panel as soon as reasonably practicable.

In determining whether under paragraph (8) there are exceptional reasons, a relevant body must have regard to the National Framework.

Subject to regulation 25 (disqualification for appointment), the CCG members and social services authority members must be appointed by the Board following nomination by a CCG or a social services authority in respect of which they are to be appointed.

Subject to regulation 27 (termination of appointment), the term of appointment of a chair, a CCG member or a social services authority member is to be such period, not exceeding three years, as the Board specifies on making the appointment.

Subject to regulation 25 (disqualification for appointment), a chair, CCG member or social services authority member is to be eligible for reappointment on the termination of the period of that chair or member's term of appointment.

The Board must pay to a chair such remuneration and expenses as appear to it to be reasonable.

Persons of the description set out in Schedule 5 are, subject to regulation 26 (cessation of disqualification), disqualified for appointment as a chair, CCG member or social services authority member.

Where the Board refuses an application to remove a disqualification, no further application may be made by that person to the Board until the second anniversary of the day of the refusal and this paragraph applies to any subsequent application.

Where a person is disqualified under paragraph 6 of Schedule 5, the disqualification is to cease on the second anniversary of the termination of the person's appointment, or at the end of such longer period as may have been specified on termination.

A chair, CCG member or social services authority member may resign at any time during their term of appointment by giving notice in writing to the Chief Executive of the Board.

Subject to paragraph (3), where the Board is of the opinion that it is not in the interests of the health service that a chair, CCG member or social services authority member should continue to hold office, it may terminate that person's appointment with immediate effect by giving notice to that person in writing to that effect.

The term of appointment of a CCG member or social services authority member must not be terminated under paragraph (2) unless the body responsible for nominating that member has been consulted.

Upon receipt of any notification referred to in paragraph (4), the person's term of appointment, if any, terminates with immediate effect and that person must cease to act as a chair, CCG member or social services authority member.

Before carrying out an assessment under paragraph (1), the relevant body must consider whether its duty under regulation 21(2) is engaged, and if so, it must comply with the requirements of regulation 21 prior to carrying out any assessment under this regulation.

Paragraph (1) does not apply if a relevant body has made arrangements for providing the person with NHS Continuing Healthcare.

In paragraphs (6A) and (6B)—

• “accommodation” means—

  1. a

     in relation to Northern Ireland, residential or other accommodation in Northern Ireland of a type which may be provided under article 15 of the Health and Personal Social Services (Northern Ireland) Order 1972 and includes a nursing home within the meaning of article 11 of the Health and Personal Social Services (Quality Improvement and Regulation) (Northern Ireland) Order 2003;

  2. b

     in relation to Scotland, residential accommodation in Scotland of a type which may be provided under or by virtue of section 12 or 13A of the Social Work (Scotland) Act 1968 or section 25 of the Mental Health (Care and Treatment) (Scotland) Act 2003;

• “local authority” has the same meaning as in section 1(4) of the Care Act 2014; and

• “relevant provider” means—

  1. a

     in relation to Northern Ireland, the person registered under Part 3 of the Health and Personal Social Services (Quality, Improvement and Regulation) (Northern Ireland) Order 2003 in respect of that accommodation;

  2. b

     in relation to Scotland, the person who provides in respect of that accommodation a care service registered under section 59 of the Public Services Reform (Scotland) Act 2010.

Where, immediately before the relevant date, a Primary Care Trust was making a flat rate payment in respect of any person pursuant to the National Health Service (Nursing Care in Residential Accommodation) (England) Directions 2007 M36, paragraph (2) applies.

Where, immediately before the relevant date, a Primary Care Trust was making a high band payment in respect of any person pursuant to direction 4 of the National Health Service (Nursing Care in Residential Accommodation) (England) Directions 2007, paragraphs (2) and (3) apply.

Where paragraph (3) applies, the Board must organise or complete the review in accordance with regulation 23 (the Board's duty: reviewing decisions).

Subject to regulation 27, the appointment of a person appointed as a chair in accordance with the Responsibilities Directions continues for such period as it would have continued if those directions had not been revoked, and such a person must be treated as if they had been appointed by the Board under regulation 23.

In this Part—

• “Continuing Care for Children” means that part of a package of care which is arranged and funded by a relevant body for a person aged 17 or under to meet needs which have arisen as a result of disability, accident or illness;

• “eligible person” means a person for whom a relevant body considers it necessary to arrange the provision of a relevant health service;

• “NHS Continuing Healthcare” means a package of care arranged and funded solely by the health service in England for a person aged 18 or over to meet physical or mental health needs which have arisen as a result of disability, accident or illness;

• “personal health budget” means an amount of money—

  1. a

     which is identified by a relevant body as appropriate for the purpose of securing the provision to a person of F30all or part of a relevant health service; and

  2. b

     the application of which is planned and agreed between the relevant body and the eligible person or their representative; and

• “relevant health service” means—

  1. a

     Continuing Care for Children; or

  2. b

     NHS Continuing Healthcare.

References in this Part to an eligible person’s representative are to such persons whom, in the opinion of the relevant body, it is appropriate to consult about, and involve in, decisions about the provision of a relevant health service to the eligible person by means of a personal health budget.

A relevant body must ensure that it is able to arrange for the provision of a relevant health service to an eligible person by means of a personal health budget which is managed in accordance with paragraph (2).

Where a request is made by or on behalf of an eligible person for a personal health budget, a relevant body must grant that request, save to the extent that it is not appropriate to secure provision of all or any part of the relevant health service by that means in the circumstances of the eligible person’s case.

Where a relevant body arranges a personal health budget under paragraph (4), it must decide which of the ways mentioned in paragraph (2) would be the most appropriate way in which to manage that personal health budget.

A relevant body must make arrangements for eligible persons for whom a personal health budget has been arranged, and their representatives, to obtain information, advice and other support in connection with the management of the personal health budget.

The duty in paragraph (5) does not apply in relation to any part of a personal health budget to which regulation 9 of the National Health Service (Direct Payments) Regulations 2013 (information, advice and other support) applies.

If a relevant body decides to refuse a request for a personal health budget made by or on behalf of an eligible person F32in full or in part, it must provide that person and their representatives with the reasons for that decision in writing.

A relevant body must inform the eligible person or their representatives in writing of the decision following a review, and state the reasons for the decision.

A relevant body may not be required to undertake more than one review following a decision under paragraph (7) in any six month period.

A relevant body must have in place arrangements for making decisions and adopting policies on whether a particular health care intervention is to be made available for persons for whom the relevant body has responsibility.

For the purposes of this regulation, a relevant body has responsibility for a person in respect of a healthcare intervention only if it has responsibility for that person in relation to services which involve, or would if the intervention was funded involve, the provision of that intervention.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

For the purposes of this Part, a health service provider, or a team led by a consultant or a health care professional, is clinically appropriate if, in the opinion of the person making the referral, they offer services that are clinically appropriate for that person in respect of the condition for which that person is referred.

F21Regulation 39(1) does not apply to any service where it is necessary to provide urgent care.

A relevant body must make arrangements to ensure that the availability of choice under the arrangements it makes pursuant to regulation 39 are publicised and promoted.

The relevant body must ensure that, in respect of a person who makes a complaint falling within paragraph (3)(a) or (b), it deals with the complaint in accordance with the procedures published pursuant to direction 7 of the Choice Directions by the Primary Care Trust that previously had responsibility for that person.

In this regulation, “clinically appropriate secondary care provider” has the meaning given in direction 1(2) and (3)(a) of the Choice Directions.

In this Part—

• “appropriate treatment” means treatment that is the first treatment provided to a person as a result of, and in response to, an elective referral;

• “eligible referrer” means—

  1. a

     a general dental practitioner,

  2. b

     a general medical practitioner,

  3. c

     a person approved to make an elective referral under arrangements made by the relevant body which has responsibility for the person being referred, and

  4. d

     any other person whose request to refer is accepted by—

     1. i

        a consultant,

     2. ii

        a member of a consultant's team, or

     3. iii

        persons providing interface services where a person who has been referred may be referred on from those services to a consultant or consultant-led team,

     who is to provide the assessment or treatment required as a result of a referral;

• “elective referral” means referral by an eligible referrer to a health service provider for assessment or treatment that is not identified as being immediately required at the time of referral;

• “each data collection period” means each calendar month and the end of such a period means the end of the last day of the calendar month in question;

• “interface services” means services that are provided otherwise than by a consultant-led team, which provide clinical triage, assessment and treatment services, but does not include mental health services or services provided under a primary care contract;

• “registered healthcare professional” means a person who is a member of a profession regulated by one of the following bodies—

  1. a

     the General Medical Council,

  2. b

     the Nursing and Midwifery Council, or

  3. c

     the Health and Care Professions Council;

• “specialist” means a registered healthcare professional working as a consultant, or as part of a consultant-led team, who specialises in the area of professional practice which is most appropriate for the diagnosis and treatment of the type of suspected cancer in question;

• “start date” means the date on which the person's referral request was received by the health service provider to whom that person has been referred for the provision of health care services by—

  1. a

     in regulations 45 to 51—

     1. i

        an eligible referrer; or

     2. ii

        themselves, with the prior approval of an eligible referrer, or

  2. b

     in regulations 52 and 53, a general medical practitioner, a general dental practitioner or a person authorised to act on their behalf;

• “suitable health service provider”, in relation to a person who has been referred for assessment or treatment, is a health service provider who—

  1. a

     can provide services which consist of, or include, treatment which is clinically appropriate for that person in response to the reasons for the referral, and

  2. b

     will provide those services pursuant to a commissioning contract with a relevant body;

• “treatment” means an intervention that is intended to manage a person's disease, condition or injury and, insofar as reasonably practicable, avoid further interventions, but does not include a therapy or healthcare intervention referred to in regulation 46(3);

• “treatment for suspected cancer” means—

  1. a

     assessment by a specialist in order to progress towards a diagnosis, or

  2. b

     treatment for suspected cancer that is provided by a specialist;

• “Waiting Times Directions” means the Primary Care Trusts and Strategic Health Authorities (Waiting Times) Directions 2010 which came into force on 1st April 2010 M48.

For the purposes of this Part, where reference is made to an appointment date being reasonable, it is reasonable if it falls at least 3 weeks after the date on which the offer of the appointment was made.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

A relevant body must make arrangements to ensure that at the end of each data collection period, not less than 92% of the persons falling with paragraph (4) have been waiting to commence F46appropriate treatment for less than 18 weeks.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The waiting time period for a person, as referred to in regulation 45(4)(c), begins with the start date and ends when any of the following paragraphs applies.

The referred person received appropriate treatment.

The referred person commenced therapy or received a healthcare science intervention where a consultant, a member of a consultant-led team or an individual providing an interface service decides that the therapy or that intervention is the treatment that is most appropriate for that person.

A person's name is added to a national transplant waiting list.

Regulation 48 applies if the conditions in paragraph (2) to (6) are met.

The relevant body which has responsibility for the person referred is satisfied that the person has not commenced or will not commence appropriate treatment within eighteen weeks, beginning with the start date.

Subject to regulation 49, where this regulation applies, the relevant body which has responsibility for the person referred must take all reasonable steps to ensure that that person is offered an appointment in accordance with paragraphs (2) to (4).

The appointment offered must be with a consultant, or a member of a consultant's team, at a suitable health service provider other than the relevant health service provider.

The appointment must be an appointment to commence treatment earlier than the person referred would have commenced treatment if they had continued to wait for treatment at the relevant health service provider.

If there is more than one suitable health service provider, the person referred must be offered a choice of appointment with more than one suitable health service provider that meets the requirements of paragraphs (2) and (3).

In this regulation and regulation 49, “relevant health service provider” has the meaning given to it in regulation 47(2).

Regulation 48 does not apply in the circumstances described in any of paragraphs (2) to (10).

The person referred decided that they did not want to commence treatment.

A person falling within regulation 47(3)(a), (b) or (c) has assessed the person referred and decided that the person requires a period of monitoring which consist of or includes being re-assessed at intervals within the period of 18 weeks beginning with the start date.

The patient is placed on the national transplant waiting list.

The patient is referred for the purpose of receiving maternity services.

The requirement referred to in paragraph (1) is that at the end of each data collection period, treatment for suspected cancer has commenced within the period of 2 weeks beginning with the start date in not less than 93% of cases where that treatment is provided in that data collection period.

In carrying out its duties under this regulation, a relevant body must have regard to the National Institute for Health and Clinical Excellence Referral Guidelines for Suspected Cancer dated June 2005 M49.

Where this paragraph applies, the relevant body which has responsibility for the person referred must take all reasonable steps to ensure that the person is offered an appointment in accordance with paragraphs (3) to (5).

The appointment must be with a specialist at a suitable health service provider other than the relevant provider.

The appointment must be at an earlier date than the appointment the person would have had if they had continued to wait for an appointment at the relevant provider.

If there is more than one suitable health service provider the patient must be offered an appointment falling within paragraphs (2) and (3) at more than one such provider.

In this Part—

• “scheme” means the arrangement between the Department of Health (England), the National Assembly for Wales, the Scottish Ministers, the Northern Ireland Department of Health, Social Security and Public Safety, Biogen Idec Inc., Bayer PLC, Merck Serono Limited, and Teva Pharmaceutical Industries Limited together with Aventis Pharma Limited, dated 1st February 2002, for the supply and administration of products for the treatment of multiple sclerosis M50;

• “scheme patient” means a patient with multiple sclerosis who is eligible to receive treatment under the scheme and who consents to receive such treatment;

• “scheme product” means—

  1. a

     Interferon beta-1a: Avonex and Rebif (22mg and 44mg);

  2. b

     Interferon beta – 1b: Betaferon; or

  3. c

     Glatiramer acetate: Copaxone,

  which is given for the treatment of multiple sclerosis and which is manufactured by a company that is a party to the scheme.