The National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012

Explanatory Note

(This note is not part of the Regulations)

These Regulations provide for a range of matters relating to the functions and commissioning responsibilities of the National Health Service Commissioning Board (“the Board”) and clinical commissioning groups (“CCGs”). They are made under powers in the National Health Service Act 2006 (c.41) (“the 2006 Act”) and the Mental Health Act 1983 (“the 1983 Act”), as amended by the Health and Social Care Act 2012 (c. 7) (“the 2012 Act”), and powers in the 2012 Act.

Part 2 of the Regulations makes provision in respect of persons for whom a CCG must or may commission services. Section 3(1A) of the 2006 Act (inserted by section 13(3) of the 2012 Act) provides for a CCG to have the duty to commission services for persons who are provided with primary medical services by a member of the CCG, and persons who usually reside in the CCG's area and who are not provided with primary medical services by a member of any CCG. Section 3A of the 2006 Act (inserted by section 14 of the 2012 Act) makes corresponding provision in relation to further services which a CCG has the power, but not the duty, to commission. By virtue of section 3(1B) of the 2006 Act, regulations may also provide for additional categories of person for whom a CCG has the duty to commission services under section 3 of that Act, and the power to commission certain other services under section 3A of that Act. Regulation 2 and Schedule 1 therefore provide for the additional categories of person for whom a CCG has the duty to commission services under section 3 of the 2006 Act, and the power to commission other services under section 3A of that Act. The list of such persons is in paragraph 2 of Schedule 1.

Part 3 of the Regulations is made under section 3B(1) of the 2006 Act. They make provision in respect of the services which the Board is required to arrange, to the extent which it considers necessary to meet all reasonable requirements, for the provision of as part of the health service. The Board is established under section 1H of the 2006 Act as inserted by section 9 of the 2012 Act. Regulation 6(a) requires the Board to arrange for the provision of dental services that are generally provided outside of a general dental practice or hospital setting such as in a community hospital or clinic, a health centre or in a person's home. Regulation 6(b) and Schedule 2 require the Board to arrange for the provision, as part of the health service, of the dental services that are specified in that Schedule.

Regulations 7 to 9 require the Board to make arrangements for the provision of secondary care services, community services and the services specified in Schedule 4 to serving members of the armed forces and their families who are registered with Defence Medical Services. Secondary care services are specialist health services which are provided on referral from a primary care practitioner. Community services include such health services as district nursing, contraceptive services, physiotherapy and home oxygen services. The services specified in Schedule 4 are specialised health services for people suffering from rare and very rare conditions. Regulation 7 also requires the Board to make arrangements for the provision of infertility treatment to serving members of the armed forces. Regulation 8 requires the Board to provide infertility treatment to severely injured members of the armed forces and veterans who have been injured in service and who are in receipt of compensation under the Armed Forces Compensation Scheme 2011 if, as a result of the injury sustained, they suffer from infertility and wish to receive infertility treatment, and they are eligible for and have been accepted for such treatment. Regulation 9 makes provision for infertility treatment to be provided by the Board in specified circumstances to the named partner of a serviceman or veteran referred to in regulation 7(1)(a) or 8(1) who has died or has become mentally incapacitated.

Regulation 10 and Schedule 3 require the Board to make arrangements for the provision of secondary care services and the services specified in Schedule 4 to prisoners and also to persons who have been detained in the other accommodation described in paragraph (2). Regulation 11 and Schedule 4 require the Board to make arrangements for the provision of the services specified in Schedule 4. Regulation 12 requires the Board to make arrangements for the continued provision of the health services currently provided by certain Independent Sector Treatment Centres pursuant to specified agreements with the Secretary of State for Health, including diagnostic and assessment services (such as screening and imaging services) and elective services (including trauma surgery, general surgery and pain management). Regulation 13 requires the Board to make arrangements for the provision of services for the specialist mental health assessment and management of persons with mental health problems who may present a risk to prominent people or locations.

Part 4 provides for the circumstances in which the duty imposed on a clinical commissioning group under section 117 of the 1983 Act, to arrange for the provision of after-care services for a person to whom that section applies, is instead be imposed on another clinical commissioning group or on the Board.

Part 5 of the Regulations makes provision as to matters which must be included in contracts to commission health care services entered into by the Board or clinical commissioning groups. Regulation 16 requires that such contracts must contain terms and conditions relating to the circumstances in which an apology and particular information must be provided where there has been a patient safety incident during the provision of health care services (“duty of candour provisions”). Regulation 17 also requires the Board to draft model terms and conditions in respect of the duty of candour provisions, and it requires both the Board and clinical commissioning groups to incorporate such terms and conditions in any commissioning contract entered into. Regulation 17 requires the Board to draft such other terms and conditions as it considers appropriate, and also empowers the Board to require clinical commissioning groups to incorporate any such further terms and conditions into any commissioning contract it enters into. Regulation 18 requires the Board to consult particular persons or bodies, such as Monitor and the Secretary of State, before drafting model terms and conditions, or revising them in any significant way.

Part 6 makes provision about NHS Continuing Healthcare and NHS funded nursing care. Regulation 21 imposes duties on the Board and clinical commissioning groups in relation to the assessment of need for NHS Continuing Healthcare, and, where appropriate, as to the provision of such care. Regulation 22 imposes requirements to work collaboratively with Local Authorities' social services as regards assessments for NHS Continuing Healthcare, in particular to ensure the continuity of services for persons who become eligible for, or cease to be eligible for, NHS Continuing Healthcare. Regulation 23 makes provision in relation to the Board's duty to organise a review where a person is dissatisfied with the procedure followed in reaching a decision as to eligibility for NHS Continuing Healthcare, or the decision itself. Regulations 24 to 27, and Schedule 5, make provision in respect of the appointment and term of office of members of a review panel, the circumstances in which a person is disqualified for appointment and the circumstances in which such an appointment can be terminated. Regulation 28 makes provision in respect of the circumstances in which the Board or a clinical commissioning group must arrange for the assessment of a person's need for nursing care, and payments that must be made in respect of nursing care where a person is found to have such a need. Regulations 29 and 30 afford protection to persons in receipt of historical rates of payment in respect of nursing care, preserving the position under the National Health Service (Nursing Care in Residential Accommodation) (England) Directions 2007. Regulation 32 revokes Directions that underpinned the previous system for NHS Continuing Healthcare and NHS-funded nursing care, and makes transitional provision in respect of matters that are on-going immediately before 1st April 2013.

The provisions in Part 7 underpin rights set out in the NHS Constitution. The Constitution states “You have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you,” and “You have the right to expect local decisions on funding of drugs and other treatments to be made rationally following a proper consideration of the evidence. If the local NHS decides not to fund a drug or treatment you and your doctor feel would be right for you, they will explain that decision to you.” Part 7 imposes duties on the Board or clinical commissioning groups to have arrangements in place for ensuring that those bodies comply with relevant NICE recommendations, and where there is no relevant NICE recommendation, for making decisions and adopting policies on whether a particular healthcare intervention is to be funded (regulation 34), including a duty to give reasons for particular policies or decisions as to whether or not to fund a healthcare intervention (regulation 35). The Board or clinical commissioning groups must have written information on the arrangements the body has in place and publish them on its website, and have them available at the main office of the body for inspection (regulation 36). Regulation 37 makes transitional provision in respect of matters on-going under the Directions to Primary Care Trusts and NHS trusts concerning decisions about drugs and other treatments 2009 immediately before 1st April 2013.

The provisions in Part 8 underpin rights set out in the NHS Constitution, namely the right to “choose the organisation that provides your NHS care when you are referred for your first outpatient appointment with a service led by a consultant”, subject to certain exceptions. Part 8 of the Regulations is made under both section 6E of the 2006 Act and section 75 of the 2012 Act, the effect being that, by virtue of section 76 of the 2012 Act, enforcement powers may be conferred on Monitor in relation to the provisions in Part 8. Part 8 imposes a duty on the Board and clinical commissioning groups to ensure that a person for whom it has responsibility and who requires an elective referral is able to choose any clinically appropriate health service provider as regards the first outpatient appointment with a consultant or a member of a consultant's team, as long as the Board or any clinical commissioning group has a commissioning contract with such a provider for the service required (regulation 39): it also imposes a duty on the Board and clinical commissioning groups to offer a choice of any clinically appropriate team led by a named consultant who is employed or engaged by that provider. Regulation 39 also imposes a duty on the Board and clinical commissioning groups to offer a choice of a team led by any clinically appropriate health care professional who is employed or engaged by the health service provider to whom the patient is referred for mental health services, where it is an elective referral. Regulations 40 and 41 set out the services in respect of which, and persons in relation to whom, the duties to offer a choice do not apply. Regulation 42 imposes duties on the Board and clinical commissioning groups as to the publication and promotion of information about choice under the arrangements made by them. Regulation 43 makes transitional provision in respect of matters on-going under the Primary Care Trusts (Choice of Secondary Care Provider) Directions 2009 immediately before 1st April 2013: prior to 1st April 2013, the Directions formed the legal basis for the NHS Constitution right but from 1st April 2013, Part 8 of the Regulations forms the legal basis of this right.

The provisions in Part 9 underpin rights set out in the NHS Constitution, namely the right to access services within maximum waiting times, or for the NHS to take all reasonable steps to offer a range of alternative providers if this is not possible. Regulation 45 imposes a duty to make arrangements to ensure that treatment appropriate to the reason for an elective referral is provided within eighteen weeks of receipt of notice of such a referral in a specified percentage of cases. Regulations 47 and 48 impose a duty to offer an alternative provider of health care services in particular circumstances where a person is not going to receive appropriate treatment within the eighteen week period, and regulation 49 sets out the exceptions to the duty, for example where a patient has decided they do not want to commence treatment. Regulation 50 requires the Board and clinical commissioning groups to have regard to a guidance document entitled “The Referral to Treatment Consultant-led Waiting Times Rules Suite” published in January 2012 in carrying out its duties under regulations 45 to 48. Regulation 51 sets out the circumstances in which a clinical commissioning group must notify the Board that a particular person will not commence treatment with the eighteen week period. Regulation 52 imposes a duty to make arrangements to ensure that where a person is urgently referred for suspected cancer, that person is provided treatment for suspected cancer within two weeks of the notice of referral being received by the health service provider in a particular percentage of cases. Regulation 53 imposes a duty to offer an alternative provider of health care services in particular circumstances where a person is not going to receive appropriate treatment in respect of suspected cancer within the two week period. Regulation 54 imposes obligations on clinical commissioning groups to establish a service providing advice and assistance to persons for whom it has responsibility and who benefit from the waiting times provisions in Part 9. Regulation 55 makes transitional provision in respect of matters on-going under the Primary Care Trusts and Strategic Health Authorities (Waiting Times) Directions 2012 which came into force on 1st April 2010, immediately before 1st April 2013.

Part 10 imposes an obligation on the Board and clinical commissioning groups in respect of the funding of certain disease modifying therapies for Multiples Sclerosis. It ensures that these bodies continue to fund such therapies in accordance with an arrangement made between the Department of Health, the National Assembly for Wales, the Scottish Ministers, the Northern Ireland Department for 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.

Part 11 concerns duties of the Board and CCGs in relation to the amount of financial resource those bodies may use in respect of administration. Section 223D(3) of the 2006 Act (as inserted by section 24 of the 2012 Act) provides that the Board must ensure that the total revenue resource use in a financial year by the Board and CCGs taken together does not exceed the amount specified by the Secretary of State. Section 223E then provides for additional controls on revenue resource use, including a provision at section 223E(3) that the Secretary of State may direct the Board to ensure that total revenue resource use, and the Board's revenue resource use, in a financial year attributable to such prescribed matters relating to administration as are specified in the directions do not exceed the amounts specified. Section 223J(3), when read with section 223J(6), then gives the Board a consequential power to direct a CCG to ensure that its revenue resource use in a financial year attributable to those prescribed matters relating to administration does not exceed an amount specified. Part 11 of the Regulations prescribes the matters relating to administration which may apply for the purposes of those directions. Paragraph (3) of regulation 2 specifies that the making of certain payments cannot be included as matters relating to administration for these purposes.

A full impact assessment has been produced in relation to the provisions of the 2012 Act and a copy is available at www.dh.gov.uk/en/Publicationsandstatistics/Publications/ PublicationsLegislation/DH_123583: in respect of Parts 1 to 4, 6, 7 and 9 to 11, no separate impact assessment has been produced as the Parts have no impact on the private sector or civil society organisations. A copy of impact assessments that relate to Part 5 (standing rules: contract terms) and Part 8 (standing rules: choice of health service provider) can be found at www.dh.gov.uk/health/2012/12/duty-candour and www.dh.gov.uk/en/Consultations/Live consultations/DH_134221 respectively.