David Lock QC is a barrister at the Landmark Chambers.
180 Fleet Street
London, EC4A 2HG
DX 1042 (London)
He was called to the Bar in 1985 and was appointed Queens Counsel in 2011.
A Guide to the law on patient choice
1. Background to patient choice issues.
2. Patient choice of GP.
3. Patient choice in secondary care.
4. The limitation of secondary care patient choice rights to a first out-patient appointment.
5. Does NHS England have patient choice arrangements in place?
6. Patient Choice arrangements by CCGs.
7. The requirements that must be fulfilled before a patient can establish "patient choice" rights under Part 8 of the 2012 Regulations.
8. The Guidance on patient choice published by the Department of Health.
9. NHS England's Guidance concerning patient choice rights.
10. The general duties on CCGs and NHS England to commission services in accordance with preferences expressed by patients.
1. Background to patient choice issues.
1.1 The principle that NHS patients should be entitled to choose where they are treated has become a key part of government policy in recent years. The underlying concept is that patients should be able to choose the clinician who they want to provide them with healthcare and that the money should follow the patient. Turning this political aspiration into reality is far from straightforward but this chapter attempts to explain how the systems are supposed to operate to deliver patient choice. Whether the choices made by patients are respected in practice is, of course, an entirely different matter.
1.2 The importance of patient choice was reflected in the key 5 year Forward View document published by NHS England which said at pages 12/13:
"We will make good on the NHS longstanding promise to give patients choice over where and how they receive care"
1.3 The importance of patient choice was also set out in the Mandate issued by the Secretary of State for 2016/17 which said:
"We want people to be empowered to shape and manage their own health and care and make meaningful choices, particularly for maternity services, people with long term conditions and end-of-life care"
1.4 The 2020 goals in the Mandate included a requirement to significantly improve patient choice. NHS England has responded to this part of the Mandate by saying on its website:
ÒNHS England is therefore committed to a major programme of work to realise the NHS "longstanding promise to give patients choice over where and how they receive care, as highlighted in the NHS Five Year Forward View."
1.5 NHS England has set up a "Patient Choice Unit" and refers to the government guidance called the "Choice Framework". The ambit of this Guidance is considered below.
The rights under the NHS Constitution
1.6 The NHS Constitution was created in 2009 to be a single summary of the "rights" that NHS patients have and the rights and expectations of NHS staff. Section 2(1) of the Health Act 2009 provides that NHS bodies must, in performing [their] ... health service functions, have regard to the NHS Constitution. The duty to "have regard" to the NHS Constitution is a legal duty to consider the NHS Constitution when exercising functions. However it is a procedural duty and does not necessarily make it unlawful for an NHS body to act in a way that contravenes the NHS Constitution. However, in order to take a lawful decision to depart form the NHS Constitution, an NHS Body would have to have very carefully considered the relevant provisions of the NHS Constitution and to have departed from it for very good reasons.
1.7 There areprovisions of the NHS Constitution relating to patient choice in both primary care and secondary care. They are referred to below.
2. Patient choice of GP.
2.1 The NHS Constitution provides as follows concerning choice and GP services:
"You have the right to choose your GP practice, and to be accepted by that practice unless there are reasonable grounds to refuse, in which case you will be informed of those reasons.
You have the right to express a preference for using a particular doctor within your GP practice, and for the practice to try to comply."
This wording is a summary of the rights given to patients by the rules under which NHS GP practices operate and does not materially add to those rights.
2.2 Patients living in the catchment area of an NHS GP practice have the right to apply to be registered at that practice. Please see chapter 6.7 for details of the application process and the limited grounds on which a GP practice with an open list can refuse to register a patient.
2.3 Once a patient is registered at a GP practice, the rules about patient preferences for seeing a particular doctor within are set out in regulation 22 of the National Health Service (General Medical Services Contracts) Regulations 2015 (SI 2016/1862) ("the GMS Regulations"). These provide that every GMS contract must contain a term to the following effect:
"22.-(1) Where the contractor has accepted an application made under paragraph 18 or 20, the contractor must-
(a) give notice in writing to the person (or, in the case of a child or an adult who lacks capacity, to the person who made the application on the applicant's behalf) of that person's right to express a preference to receive services from a particular performer or class of performer either generally or in relation to any particular condition; and
(b) record in writing any such preference expressed by or on behalf of that person.
(2) The contractor must endeavour to comply with any reasonable preference expressed under sub-paragraph (1) but need not do so if the preferred performer-
(a) has reasonable grounds for refusing to provide services to the person who expressed the preference; or
(b) does not routinely perform the service in question within the contractorÕs practiceÓ
An identical provision is in Regulation 21 of the National Health Service (Personal Medical Services Agreements) Regulations 2015.
2.4 In accordance with these Regulations, once a patient is accepted onto the list of an NHS GP practice, the contractor must inform the patient of the right to "express a preference to receive services from a particular performer or class of performer either generally or in relation to any particular condition" and that, if a patient expresses a preference, the practice "must endeavour to comply with any reasonable preference".
2.5 Thus if a patient expresses a preference to see Dr Ahmad, the practice must operate a system which endeavours to comply with this preference. Patients can also request to be treated by a "class of performer". This may raise some difficult issues about discrimination. This provision could be used to permit a female patient to express a preference to see a woman doctor, particularly if she needs to be treated for gynaecological or family planning matters. Equally, a male patient may express a preference for being treated by a male doctor if he has erectile dysfunction problems. Patients for whom English is a second language may properly ask to be seen by "class" of doctors who can speak their language. However, it is almost certainly not permissible to use this part of the contract for a patient to express a preference only to be seen by a "white doctor".
2.6 There are different ways that the practice can comply with this requirement in practice, including ensuring that the practice computer system informs the receptionist where a patient has expressed a preference and prompts the receptionist to offer an appointment with the patient's preferred GP.
3. Patient choice in secondary care.
3.1 Patient choice in secondary care is more complex than in primary care. The rules are both substantive and procedural but there is considerable ambiguity about what the rules mean and there have been attempts to cut down the ambit of the rules by "Guidance" produced by NHS England. Accordingly, the extent to which patients can exercise any meaningful choice in secondary care is somewhat unclear.
The gatekeeping role of the GP or other primary care professional.
3.2 Patients make their own choices about when they visit primary care. In contrast, NHS patients can only make their own choices about the provider that delivers NHS funded secondary care where they seek care on an emergency basis or where a patient is referred for a specific secondary care procedure by their GP, community dentist or an optometrist. The vast majority of referrals are made by GPs and so this chapter will describe patient choice rights by reference to a GP. However, the same principles apply to referrals by community dentists and optometrists.
3.3 Patient choice is generally concerned with elective procedures as opposed to emergency procedures, and the role of the GP as "gatekeeper" in the system is essential. Giving effect to patient choice for secondary care is not, in reality, giving effect to a choice for the patient alone. It is giving effect to joint decision making between a GP and the patient. The GP makes the decision to offer a referral and, if the patient agrees to the proposed referral, the patient has the right to be referred to any clinically appropriate provider who contracts with the NHS.
The sources of the legal right to exercise choice in secondary care.
3.4 Patient choice is delivered by 2 complimentary processes, namely:
i) Specific occasions on which a patient can establish a legal right to choose their secondary care provider in a specific case; and
ii) General procedural duties which are imposed on NHS England and CCGs (which are only relevant where (i) does not apply).
The duty on CCGs and NHS England to make patient choice arrangements.
3.5 Part 8 of the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 (Òthe 2012 Regulations sets up the system of legal rights of patients to make their own choices about which provider should provide treatment to them. Subject to the terms of the Regulations, patients have a legal right to choose the secondary care provider to whom they are referred for a first appointment by their NHS GP (and certain other NHS primary care professionals) where the GP decides that the patient requires an Òelective referralÓ.
3.6 Regulation 38 defines the meaning of an "elective referral" as follows:
""elective referral" means referral by a general medical practitioner, general dental practitioner or optometrist to a health service provider for treatment that is not identified as being immediately required at the time of referral"
3.7 Hence, a patient cannot "self-refer" for secondary NHS care and claim to exercise patient choice rights in respect of that referral. The person making the referral must be a GP, community dentist or optometrist. Further the rules about choice for elective referrals do not apply to emergency procedures and so a referral by a GP for treatment that is "immediately required" does not give rise to patient choice rights.
3.8 The elective referral must be made to a "health service provider" This term is widely defined in Regulation 2 of the 2012 Regulations to mean:
""health service provider" means a person, other than a relevant body, who has entered into a commissioning contract"
3.9 Accordingly, a health service provider can be any public body, commercial organisation or third sector body, provided it holds a "commissioning contract" with any CCG or NHS England (referred to in the Regulations as the "relevant body". There is some controversy about what is meant by a "commissioning contract". The proper ambit of this term is considered below. It is possible that guidance on the meaning of the term "commissioning contract" will be given when the High Court gives judgment in R (AA) v Haringey CCG (which is expected in late 2016). However the starting point is that this term is defined in Regulation 2 as follows:
""commissioning contract" means a contract, other than a primary care contract, entered into by a relevant body in the exercise of its commissioning functions"
Hence, the Regulations appear to define the term "commissioning contract" as meaning any contract entered into by a CCG or NHS England in exercise of their commissioning functions other than a primary care contract.
3.10 Regulation 39 of the 2012 Regulations provides:
(1) A relevant body must make arrangements to ensure that a personÑ
(a) who requires an elective referral; and
(b) for whom that body has responsibility,
is given the choices specified in paragraph (2).
(2) Subject to regulations 40 and 41, the choices specified for the purposes of this paragraph are the choice-
(a) in respect of a first outpatient appointment with a consultant or a member of a consultant's team, of-
(i) any clinically appropriate health service provider with whom any relevant body has a commissioning contract for the service required as a result of the referral, and
(ii) any clinically appropriate team led by a named consultant who is employed or engaged by that health service provider; and
(b) in relation to an elective referral for mental health services in respect of which the patient's first outpatient appointment is not with a consultant or a member of a consultant's team, of-
(i) any clinically appropriate health service provider with whom any relevant body has a commissioning contract for the service required as a result of the referral, and
(ii) any clinically appropriate team led by a named health care professional who is employed or engaged by that health service provider.
(3) . . .
(4) . . .
(5) The arrangements referred to in paragraph (1) must include such arrangements as are necessary to ensure that a person may make the choices specified in those paragraphs where that personÑ
(a) has not been offered that choice by the person making the initial referral; and
(b) notifies the relevant body who has responsibility for that person that that choice was not offered.
(6) 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.
3.11 Regulation 39(1) imposes a legal duty on each CCG and NHS England to Òmake arrangementsÓ to give effect to the right of patients to exercise their patient choice rights. The imposition of a legal duty Òto make arrangementsÓ is used throughout the NHS Act. It imposes a legal obligation on the CCG to operate systems which ensure that patients can access those services that are within the scope of the arrangements. In Tandy v East Sussex CC  A.C. 714 the House of Lords was concerned with a duty to make arrangements to provide suitable education services to children in its area. Whilst emphasising that the council had a discretion to decide the form of these arrangements, Lord Browne-Wilkinson said at page 747:
"The duty is to make arrangements for what constitutes suitable education for each child. That duty will not be fulfilled unless the arrangements do in fact provide suitable education for each child"
3.12 It follows that, when making decisions as to whether to fund medical treatment for an NHS patient, regulation 39(1) requires both CCGs and NHS England to put in place a decision making processes, which asks 4 questions, namely:
i) Is this patient a person for whom the CCG/NHS England has commissioning responsibility;
ii) Is this patient a person who "requires" an elective referral; and
iii) Do the patient's circumstances come within Regulation 39(2); and
iv) Is the patient entitled to exercise patient choice rights for this particular episode of treatment.
3.13 The decision making process in the policy which constitutes the "arrangements" must provide that if the answer to all 4 questions is "yes", the CCG or NHS England must make a decision to fund the initial consultation with the preferred secondary care clinician which is the subject of the referral. That appointment must be funded because the patient's "legal right" to have NHS funded treatment have been established and so the CCG or NHS England ceases to have a discretion to decide whether to fund the treatment or not as part of NHS funded care. It follows that any set of legal "arrangements" must set up a decision making process that guide a decision maker to ask whether the answer to all 4 questions set out above are answered in the affirmative.
3.14 Regulation 39(6) provides that the assessment as to whether the referral is clinically appropriate is exclusively a matter for the person making the referral, not for the CCG or NHS England. Hence, the decision making processes cannot allow the commissioner to reach their own view as to whether the referral is appropriate treatment to be funded as part of NHS care.
4 The limitation of secondary care patient choice rights to a first out-patient appointment.
4.1 The right of patients to choose their secondary care provider under the Regulations is limited to a "first appointment". On the face of it this seems a strange limitation because it suggests that a patient only has a very limited right to choose who the patient should be treated by and thereafter must accept the choice foisted on the patient by the NHS commissioner. As far as the author is aware, neither the government nor NHS England has advanced a policy reason why the right to patient choice under Part 8 of the 2012 Regulations is limited to a first out-patient appointment.
4.2 In the absence of any other explanation, it seems that the limitation of the right to a first out-patient appointment reflects a compromise between the interests of NHS commissioners and those of individual NHS patients. NHS commissioners have no absolute duty to commission every clinically appropriate service for an NHS patient. CCGs are entitled to adopt policies to define the services that they wish to commission for the patients for whom they are responsible in order to manage their budgets: see for example R v Cambridge Health Authority ex parte B  1 WLR 898 and R (AC) v Berkshire West Primary Care Trust & Anor  EWCA Civ 247. In contrast, NHS England and CCGs are not entitled to have blanket policies to refuse to fund particular treatments and have a legal duty to consider requests to commission care for a patient outside their usual policies and to make decisions whether to commission the requested treatment: see R v North West Lancashire Health Authority ex parte A  1 WLR 977 and Regulations 34 and 35 of the 2012 Regulations.
4.3 It follows the purpose of limiting the legal right of a patient to choose their provider for a first out-patient appointment appears to be designed to enable the provider of the patient's choice to have a first meeting with the patient, funded by the NHS, to discuss treatment options. Following this first appointment the patient can then request the NHS commissioner for funding to support a full course of treatment with the patient's favoured provider (either as part of an existing CCG or NHS England policy or as an individual funding request outside the policy).
4.4 The purpose of limiting the legal right to a first out-patient appointment appears to allow the patient to be seen by the secondary care provider of the patient's choice and for the CCG (or NHS England) to be informed by the secondary care provider what treatment that provider recommends for the patient. The CCG (or NHS England) is then in a better position to make a decision whether to commission further treatment for the patient. It is also relevant to note:
i) When making decisions about funding further treatment, both NHS England and CCGs must comply with their general procedural duties (see below) to exercise their functions with a view to enabling patients to make choices with respect to aspects of health services provided to them; and
ii) Each CCG must have regard to the Guidance issued by NHS England concerning whether to commission any further treatment in accordance with the patient's choice: see section 14Z8 of the NHS Act.
4.5 Accordingly, properly understood, the legal framework appears to represent a balance between the interests of the individual patient and the interests of the NHS commissioner, who acts on behalf of the general body of patients for whom the NHS commissioner is required to commission services.
5 Does NHS England have patient choice arrangements in place?
5.1 NHS England has no policy on its website which informs patients how decision makers within NHS England are required to give effect to patient choice rights when services are commissioned by NHS England. It is therefore unclear what arrangements, if any, have been put in place by NHS England to ensure that patients can exercise their choice rights when referred for care commissioned by NHS England.
5.2 The department of NHS England which regulates CCGs appears to be focused on making sure CCGs respect the patient choice rights of patients. The NHS England website says:
ÒClinical commissioning groups (CCGs) have a duty to enable patients to make choices, and to promote their involvement in decisions related to their care or treatment. NHS England will work alongside CCGs to help them meet their legal responsibilities and build on their offer of choice to patients, to ensure that choices are meaningful and deliver positive improvements to patient outcomes including patient experience of the services they access and use.
The initial priorities of this programme of work are:
á Strengthening choice in outpatient services
á Enhancing the choice available in maternity services, including through a programme of Pioneers to develop and test ways of improving choice in maternity services for national replication
á Improving choice in end of life care (EOLC) (including ensuring more people are able to achieve their preferred place of care and death)
á Securing choice in the new care models that some Vanguard areas of the country are developing.
More information on these priority areas will be available via this webpage by summer 2016.
5.3 However, it is less clear how NHS England is complying with its own patient choice obligations. If NHS England does not have any "patient choice" arrangements in place then it will be acting in breach of its duty under Regulation 39 and any decisions which fail to respect patient choice rights could be challenged by way of judicial review.
6 Patient Choice arrangements by CCGs.
6.1 There are some CCGs with well developed Òpatient choice policesÓ. A good example is Blackpool CCG (see http://blackpoolccg.nhs.uk/patient-choice/). However, there are many other CCGs that have no specific policy which explains patient choice to patients and, crucially, to decision makers within the CCG. As with NHS England, CCGs will be acting unlawfully if they do not have a policy which guides decision makers to identify and respect appropriate choices made by patients.
6.2 The legal rights given by Part 8 of the 2012 Regulations need to be seen within the overall legal structures operating in the NHS. These structures provide that that decisions about which NHS funded medical treatment should be provided to an NHS patient are primarily a matter to be decided between the patient and their treating NHS GP or other primary care clinician. This balance between the decision making power of GPs and the powers of the CCG is seen in 3 areas in particular, namely:
i) Drugs or medical appliances prescribed for patients by a GP;
ii) NICE recommended treatments for NHS patients (usually prescribed within secondary care); and
iii) Patient choice rights for secondary care recommended by a GP or other primary care clinician.
Drugs or medical appliances prescribed for patients by a GP
6.3 The question as to whether a pharmaceutical drug should be provided to patients of a GP practice is, in the first instance, a matter exclusively for the GP. A CCG cannot impose any fixed cost limit on the pharmaceutical drugs a GP can prescribe for an NHS patient and which must be funded by a CCG as part of NHS funded care. See regulation 56 of the GMS Regulations. The only exceptions are the "black list" of drugs published by the Secretary of State that an NHS GP cannot prescribe and a "grey" list of products such as Viagra which can only be prescribed in limited circumstances. However outside these limited examples, the only restraint on GPs and other primary care clinicians on prescribing is in Regulation 64 of the GMS Regulations which provides:
"(1) The contractor must not prescribe drugs, medicines or appliances the cost or quantity of which, in relation to a patient, is, by reason of the character of the drug, medicine or appliance in question, in excess of that which was reasonably necessary for the proper treatment of the patient.
(2) In considering whether a contractor has breached its obligations under paragraph (1), the Board must seek the views of the Local Medical Committee (if any) for the area in which the contractor provides services under the contract."
6.4 Save where GPs are prescribing branded drugs when generics are available, the requirement not to prescribe drugs where the cost or quantity is "in excess of that which was reasonably necessary for the proper treatment of that patient" is almost impossible to enforce because the GP must follow GMC Guidance in prescribing the most appropriate drug for the patient regardless of the cost. A drug should only be prescribed for a patient where the patient agrees to take the drug (or it is a waste of NHS resources), but a joint decision between the GP and the patient on the choice of drug binds the CCG. Once the prescription is written, the patient goes to an NHS pharmacy which dispenses the drug to the patient. The pharmacist then makes a financial claim from the NHS Business Services Agency for payment for dispensing the drug (where the payment depends on the type of the drug). The cost of the drug eventually makes its way back to the local clinical commissioning group. CCGs can encourage GPs to limit costs when prescribing drugs but have no powers to prevent GPs exercising their clinical judgement to prescribe the drug GP considers most appropriate for the NHS patient.
NICE recommended treatments for NHS patients (usually prescribed within secondary care).
6.5 There is, in principle, no limit on the types of drugs or other treatments that a secondary care provider, such as a Hospital Trust, can provide to an NHS patient. However, the contract between a CCG (or NHS England) and a secondary care provider can place limits on the costs that a secondary care provider can recover from the CCG. Secondary care providers will usually prevent clinicians providing expensive drugs or other medical interventions for an NHS patient unless the secondary care provider can recover the costs of those drugs or interventions from the CCG.
6.6 However, CCGs are obliged to fund drugs or other treatments provided to patients where the drug or medical appliance is recommended in a Technology Appraisal Guidance (ÒTAGÓ) by the National Institute for Health and Social Care Excellence (ÒNICEÓ). A combination of section 237(8) of the Health and Social Care Act 2012 and Regulation 34 of the 2012 Regulations means that CCGs must have arrangements in place which require the CCG to fund drugs or treatments for patients with medical conditions which come within a cohort defined by a NICE TAG. Regulation 34 provides:
"1) 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.
(2) Arrangements under paragraph (1) must-
(a) ensure that the relevant body complies with relevant NICE recommendations; and
(b) include arrangements for the determination of any request for the funding of a health care intervention for a person, where there is no relevant NICE recommendation and the relevant body's general policy is not to fund that intervention"
6.7 This right is repeated in the NHS Constitution which says:
"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"
6.8 Thus, a CCG may not lawfully adopt a policy not to reimburse a secondary care provider for providing drugs or treatments to patients with medical conditions which come within a cohort defined by a NICE TAG.
7 The requirements that must be fulfilled before a patient can establish "patient choice" rights under Part 8 of the 2012 Regulations.
7.1 The wording of Part 8 of the 2012 Regulations provides that NHS patients have a legal right to have a referral funded by their CCG or NHS England for the first consultation with the clinician to whom they are referred by their GP if the following conditions are satisfied:
i) Condition 1: The patient is a patient for whom the CCG has responsibility (Regulation 39(1)(b));
ii) Condition 2: The patient requires an elective referral (Regulation 39(1)(a)). The wording of the regulation is that the patient requires an elective referral, not that the patient requires an elective referral for a form of treatment that the CCG considers she ought to receive. Regulation 39(6) provides that the exercise of clinical judgement to determine what treatment the patient requires is for the GP and not the CCG;
iii) Condition 3: A referral has been made by the patientÕs GP to a Òclinically appropriate providerÓ (Regulation 39(2)(a) and (b)). However Regulation 39(6) provides that whether a provider is clinically appropriate is solely a decision for the person making the referral;
iv) Condition 4: The provider to whom the patient is referred has a commissioning contract with a Òrelevant bodyÓ for the service required by the referral (see Regulation 39(2)(a) and (b)). The expression Òrelevant bodyÓ is also defined in Regulation 2 as follows:
""relevant body" means a CCG or the Board"
Thus, this condition is satisfied if any CCG or the Board (known as NHS England) has a commissioning contract for the service required by the referral with the proposed provider. It is not necessary for the patientÕs own CCG to have an existing contract with the proposed provider for the proposed service;
v) Condition 5: The service is not of a type listed in Regulation 40 where the choice right does not apply. The services that are exempted from patient choice rights are:
a. Cancer services (where a 2 week wait right arises Ð as to which see below);
b. Maternity services; and
c. Services for which the patient has a need for urgent care;
vi) Condition 6: The patient is not a person who comes within Regulation 41 (which defines those patients who cannot exercise choice). The following patients do not have patient choice rights under Regulation 41:
a. Patients detained under the Mental Health Act 1983;
b. Patients who are detained in or on temporary release from prison, in an immigration removal centre , secure training centre or detained other accommodation described in regulation 10(2) of the 2012 Regulations; or
c. Patients who are serving as a member of the armed forces.
7.2 Mental Health services were excluded from patient choice rights when the 2012 Regulations were originally made. However, mental health services were removed from the list of excluded services with effect from 1 April 2014 by the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) Regulations 2013. It follows that, from 1 April 2014, mental health patient gained the same legal rights to choose a secondary care provider from that date as other NHS patients.
8 The Guidance on patient choice published by the Department of Health.
8.1 The Department of Health has published Guidance concerning the 2015/16 Choice Framework. This suggests that the only occasions where a patient does not get the legal right to access treatment following a GP referral to a secondary care provider are those set out in the Regulations. An example of the exercise of patient rights is given in the recent Guidance from the Secretary of State as follows:
"Fatima is suffering from a mental health condition and visits her GP to be referred for treatment. She would like to exercise her entitlement to choose a named health care professional, whose team will then be responsible for her care. She has heard of a particular consultant that she would like to go to for her treatment and discusses this with her GP. He uses the NHS e-Referral Service to search for this named consultant and show Fatima the list of organisations and locations where the consultant works. Her GP creates a shortlist from these options and gives her log-in details for the NHS e-Referral service so she can do some research at home before deciding which one she would like to choose for her first outpatient appointment.
Fatima uses NHS Choices to research each organisation before choosing one that is close to where she lives and has a number of convenient available appointments. A close friend of hers has also received treatment at this organisation and tells her that the quality of care is good. Fatima logs into the NHS e-Referral Service, selects her chosen organisation and books an appointment. She will be treated by her chosen health care specialist or a member of their team"
8.2 There is no suggestion in the Secretary of State's Guidance (or in the example above) that the legal right to choose is constrained by whether the patient's chosen provider holds a "Standard NHS Contract" or whether the treatment for which the patient is referred is treatment that is routinely commissioned by the patient's CCG.
9 NHS England's Guidance concerning patient choice rights.
9.1 NHS England takes a substantially different approach to the conditions which must be satisfied before patient choice rights arise. Despite the many statements made by NHS England in support of the concept of patient choice and the existence of a team within NHS England which promotes patient choice, Guidance issued by NHS England following the inclusion of mental health patients within the patient choice rights framework seeks to place additional restrictions on the ability of all NHS patients to exercise patient choice rights.
9.2 NHS England published interim Guidance on patient choice in mental health services in May 2014 and then published final guidance in December 2014. The December 2014 NHS England Guidance suggests that, in addition to the qualifying criteria set out in the 2012 Regulations, there are 2 further restrictions on patient choice rights, namely:
i) The referral must be for treatment which is of a type which the patient's own CCG routinely commissions; and
ii) The "commissioning contract" held by the provider must be in the form of an NHS Standard Contract and not any other form of contract.
9.3 However, the Regulations must apply equally to patient choice for physical and mental health conditions because they are both governed by the same regulatory structure. It follows that the additional restrictions on patients' rights to exercise their Part 8 choice rights suggested by NHS England must either apply to both physical and mental health services or not apply to any NHS services. For the reasons set out below, the latter appears likely.
Are the additional NHS England restrictions on patient choice part of the law?
9.4 A conventional approach to statutory construction would suggest that a patient who could show that he or she satisfied each of the 6 conditions laid down by the 2012 Regulations would have a legal right to require the CCG to fund a referral made by his or her GP. There must, at the very least, be serious questions as to whether NHS England has acted lawfully in publishing guidance suggesting there are additional conditions that a patient must meet before a patient choice right arose. There would also be serious issues about the legality of any CCG refusing to recognise a patient choice had been established where the patient satisfied the 6 conditions set out in the 2012 Regulations but was denied the right to exercise patient choice based on the NHS England additional restrictions. The legality of the additional restrictions may be tested when the case of R (AA) v Haringey CCG comes to court in December 2016.
The suggestion in NHS England Guidance that the referral must be for treatment which is of a type which the patient's own CCG routinely commissions
9.5 The NHS England Interim Guidance provided at pages 4/5:
"Since 1 April 2013, people with mental health conditions who have been referred for a first outpatient appointment have had a right to choose who treats them within the organisation providing their care and treatment. This means having a right to choose which team, led by a named healthcare professional, delivers their care and treatment. Until April 2014, this right was limited to a mental health provider with which the patient's clinical commissioning group (CCG) or NHS England had contracted.
The right to choice is no longer limited to mental health providers that have a contract with the CCG responsible for that patient, but is extended to other providers with a contract with any CCG, in the same way there is a right to choice of provider in physical health. This is an important step both towards establishing "parity of esteem", or equal status, between mental and physical health services in the NHS and towards improving access, personalising and improving both the quality of care that people receive and, ultimately, their health outcomes"
9.6 That part of the Interim Guidance appears to be correct. However the Interim Guidance goes on to say:
"These changes mean that a patient who requires an elective referral for mental health services has a right from 1 April 2014 to choose any clinically appropriate health service provider (whether an NHS mental health trust, a Foundation Trust or a mental health provider in the independent or third sector) for the their first outpatient appointment as long as the provider has a contract with any CCG or with NHS England for the service required, and that the service or treatment is routinely commissioned by the patient's CCG or NHS England, or is approved by the relevant Independent Funding Review Panel. This brings mental health services a step closer towards "parity of esteem", or equal status, with physical health services in the NHS" [Emphasis added]
9.7 This Guidance thus suggested patient choice rights were restricted to services that are already "routinely commissioned" by a CCG or where a specific commissioning decision was made by a CCG to support the commissioning of the service. This proposed restriction is repeated in the next part of the Interim Guidance which says:
"Consistent with the operation of choice in physical health care, patients cannot generally choose services or treatments which are not routinely commissioned by their local CCG or NHS England. Patients wishing to access services not commissioned by their CCG or (where relevant) NHS England, may seek to demonstrate exceptionality and so access funding for the treatment through the commissioner's Independent Funding Review Panel. Patients should discuss their options with their GP who is required to support such an application"
9.8 In December 2014 NHS England published guidance on "Choice in Mental Health Care". In the introduction the NHS England Medical Director, Prof Sir Bruce Keogh states:
"The changes in law that have given patients with mental health conditions the same legal rights as they have in physical health services are a significant step towards parity. They are part of the more significant shift to increase the direct control patients have over their care and every one of us working in mental health has a part to play to help implement these rights and make them work well for patients"
9.9 This guidance provides at page 4:
"This guidance seeks to interpret these regulations and set out the principles for how these legal rights to choice should operate. It is important to note that the right choice does not mean that a patient only has their first outpatient appointment with their chosen provider: consistent with physical health care, once a patient has chosen a provider, that provider will normally treat the patient for their entire episode of care unless the patient's diagnosis changes significantly"
9.10 However the NHS England Guidance departs from the terms of the Regulations in suggesting that a patient's legal right to choose a provider was limited as follows:
"As is the case in physical health, the legal rights to choose in mental health do not give a legal right to choose their treatment. It is for commissioners to decide which services to secure in order to meet the needs of their local population. Where commissioners routinely commissioned particular mental health services, eligible patients may choose any provider team, in line with the description above, to access those services. Where patients, with the support of their GP, wish to access services that are not routinely commissioned by their responsible commission, they may apply through the Commissioner's Individual Funding Request (ÒIFRÓ) process or if in receipt of a personal health budget through the care planning process"
9.11 This wording follows the Interim Guidance but appears to confuse 2 different matters namely (a) whether patients can choose which NHS medical services they wish to access without the support of their GP and (b) whether the clinical decision maker should be the patient's referring clinician or the CCG. Neither the 2009 Choice Directions which preceded Part 8 of the 2012 Regulations nor Part 8 of the 2012 Regulations gives the patient a "choice of treatment" which is not supported by the patient's clinician. However, neither the 2009 Choice Directions nor Part 8 of the 2012 Regulations contain any wording which suggest that the CCG has the right to restrict the choices agreed between the patient and the patient's referring GP.
9.12 If it were to have been the Secretary of State's intention that patient choice rights should be restricted to services that are routinely commissioned by the patient's CCG or approved by way of that CCG's IFR panel, it is surprising that this important restriction is not referred to in either the Regulations or in the Department of Health Guidance. These Regulations were, after all, made by the Secretary of State and not by NHS England.
9.13 The duty on a CCG under Regulation 39(1) is to make arrangements to fund a first appointment for patients who "require" an elective referral. The use of the word "require" appears to echo the duty on the CCG under section 3(1) of the National Health Service Act 2006 ("the NHS Act"), namely that:
"A clinical commissioning group must arrange for the provision of the following to such extent as it considers necessary to meet the reasonable requirements of the persons for whom it has responsibility ..."
9.14 However, the 2012 Regulations were made by the Secretary of State in exercise of his powers under section 6E of the NHS Act which provides that the Secretary of State may make Regulations which direct CCGs how they are required to exercise their commissioning responsibilities. There are wide powers in section 6E(2) to make Regulations directing CCGs as follows:
"The regulations may, in relation to the commissioning functions of the Board or clinical commissioning groups, make provision-
(a) requiring the Board or clinical commissioning groups to arrange for specified treatments or other specified services to be provided or to be provided in a specified manner or within a specified period;
(b) as to the arrangements that the Board or clinical commissioning groups must make for the purpose of making decisions as to-
(i) the treatments or other services that are to be provided;
(ii) the manner in which or period within which specified treatments or other specified services are to be provided;
(iii) the persons to whom specified treatments or other specified services are to be provided;
(c) as to the arrangements that the Board or clinical commissioning groups must make for enabling persons to whom specified treatments or other specified services are to be provided to make choices with respect to specified aspects of them"
9.15 These powers add to the commissioning responsibilities under section 3(1) and thus the limitation suggested by the NHS England Guidance does not appear to be consistent with these extensive powers. Further Regulation 39(1) appears reasonably clear that the decision maker as to whether a patient "requires" a secondary care referral is the patient's GP as opposed to the CCG.
9.16 The ambit of the right is also important. It is a right for a first consultation and the strict legal right does not extend beyond the first consultation. Hence, a right to a first consultation with a secondary care clinician in an area of treatment that the CCG would not routinely fund does not necessarily lead to the CCG having any further extended liability for treatment. It follows that this part of the NHS England Guidance appears to be legally incorrect mainly because a limitation to a referral for treatment that the CCG routinely commissions is not a limitation which is set out in the 2012 Regulations.
9.17 The author thus expresses the view that, as a matter of law, a patient who is referred by his or her GP for a first appointment with a secondary care clinician who has a contract with another CCG or NHS England but seeks a type of care which the patients CCG does not routinely commission can establish a legal right to an NHS funded first appointment under Part 8 of the 2012 Regulations.
The observations in the NHS England Guidance about the need for the provider to have an NHS Standard Contract.
9.18 The NHS England Guidance suggests that a provider will only qualify for patient choice rights if the provider holds a Standard NHS Contract for the service in question and that any other type of contracting arrangement will not suffice to give rise to patient choice rights. This additional requirement is not in the Department of Health Guidance and appears to be even more problematic than the suggestion that the service is limited to a service that the CCG routinely commissions.
9.19 This suggested limitation was not included in the May 2014 Interim Guidance but was set out in the December 2014 NHS Guidance. This says at page 6:
"Routinely commissioned services are the types of treatments that commissioners secure for their populations on an ongoing basis, through the award of NHS Standard Contracts. These treatments exclude spot contracts between a commissioner and a provider on a one-off basis for the treatment of a specific patient"
9.20 Thus, the Guidance suggests that if a CCG enters into a "spot contract" with a provider to treat a specific patient, that contract cannot be relied on by other patients in order to establish a right to be referred to that provider. There are 2 major problems with this suggested limitation. First, in entering into these contracts, CCGs are discharging commissioning functions in relation to particular patients under section 3(1) of the NHS Act. Accordingly, these contracts constitute "commissioning contracts" within the definition of that term in Regulation 2 of the 2012 Regulations. There is a full definition of the term "commissioning contract" in Regulation 2 of the 2012 Regulations as follows:
""commissioning contract" means a contract, other than a primary care contract, entered into by a relevant body in the exercise of its commissioning functions"
9.21 The attempt in the NHS England Guidance to restrict the meaning of the term "commissioning contract" to a contract which was concluded using the NHS Standard Contract is thus not contained within the wording of the 2012 Regulations. If it were the definition would read:
""commissioning contract" means a contract, other than a primary care contract, entered into by a relevant body in the exercise of its commissioning functions which, if entered into by a CCG, is in a form that complies with any obligations on a CCG under Part 5 of these Regulations and if entered into by the Board is in a like form"
9.22 However, this is not what the 2012 Regulations provide. It follows that the Guidance is attempting to introduce limitations which do not appear in the Regulations. Guidance which attempts to impose obligations on a statutory scheme or to re-interpret the form of the statutory scheme is unlawful: see for example R (Simpson) v Police Medical Appeal Board & Ors  EWHC 808 (Admin).
9.23 The second difficulty in suggesting that a "commissioning contract" should mean "a commissioning contract in the form of an NHS Standard Contract and not in any other form" is that a CCG that entered into a commissioning contract in any form other than the NHS Standard Contract would be acting in breach of NHS England's own rules. Hence a CCG would not be acting lawfully in entering into a "spot contract" with a provider for the delivery of NHS services to a patient in any form other than the NHS Standard Contract.
9.24 The requirement on CCGs to use the NHS Standard Contract when commissioning all NHS services is set out in Part 5 of the 2012 Regulations which is headed "Standing rules: commissioning contract terms". Regulation 16 provides :
"(1) The Board must draft-
(a) terms and conditions making provision for the matters specified in regulation 16; and
(b) such other terms and conditions as the Board considers are, or might be, appropriate for inclusion in commissioning contracts entered into by a relevant body.
(2) The Board may draft model commissioning contracts which reflect the terms and conditions it has drafted pursuant to paragraph (1).
(3) A relevant body must incorporate the terms and conditions drafted by virtue of paragraph (1)(a) in commissioning contracts entered into by it.
(4) 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.
(5) If a CCG is required by the Board to incorporate terms and conditions pursuant to paragraph (4), it must do so"
9.25 NHS England has complied with this obligation by publishing the NHS Standard Contract, which is revised on annual basis. NHS England has exercised the power under Regulation 17(4) to require CCGs to use the NHS Standard Contract. The NHS England website says:
"The NHS Standard Contract is mandated by NHS England for use by commissioners for all contracts for healthcare services other than primary care"
9.26 NHS England also produces ÒTechnical GuidanceÓ each year concerning the legal obligations on NHS bodies to use the NHS Standard Contract. Although these documents describes themselves as being "Guidance", the documents set out the rules set by NHS England exercising its powers under Regulation 17 of the 2012 Regulations. Accordingly, CCGs have a legal duty to follow the rules set out in the Technical Guidance document as opposed to merely having a duty to have regard to them. Para 5.2 of the 2015/16 Technical Guidance provides:
"5.2 The NHS Standard Contract must be used by CCGs and by NHS England where they wish to contract for NHS-funded healthcare services (including acute, ambulance, patient transport, continuing healthcare services, community-based, high-secure, mental health and learning disability services). The Contract must be used regardless of the proposed duration or value of a contract (so it should be used for a small-scale short-term pilots as well as for long-term or high-value services). Where a single contract includes both healthcare and non-healthcare services, the NHS Standard Contract must be used.
5.3 The only exceptions are:
á primary care services commissioned by NHS England, where the relevant primary care contract should be used; and
á any primary care improvement schemes agreed by CCGs with GP practices (with contractual arrangements, involving a variation or supplement to existing general practice contract, agreed between local NHS England teams and CCGs). Such Local Improvement Schemes involve payments for improving the quality of services provided under an existing GP contract, not the commissioning of additional services [Emphasis added]"
9.27 The compulsory nature of the obligations set out in these paragraphs is shown by the use of the word "must" in the first line of paragraph 5.2. It follows that, at least until April 2016, CCGs were under a legal obligation to use the NHS Standard Contract whenever they were commissioning ÒNHS funded healthcare servicesÓ unless the services were exempted because they came within the type of services set out in paragraph 5.2. CCGs may now use an approved form of "NHS Contract light" but cannot enter into commissioning contracts in any other form.
9.28 Three points appear to emerge from the 2015/16 rules concerning the extent of the legal obligations on CCGs to use the NHS Standard Contract which are relevant to the issue of patient choice, namely:
i) There is no exemption from the legal duty where the proposed contract is of low value. The legal duty to use the NHS Standard Contract arises regardless of the value of the contract;
ii) There is no exemption from the mandated duty to use the NHS Standard Contract where the commissioning decision has been made by an IFR panel. The Technical Guidance shows that the fact that the commissioning decision has been made through an IFR process as opposed to be made by any other process does not exempt a CCG from using a Standard NHS Contract when putting the IFR commissioning decision into effect; and
iii) There is no exemption from the duty to use the NHS Standard Contract where services are being commissioned by a CCG for a single patient as opposed to being commissioned for cohorts of patients. This is clear from the rules in paragraph 5.2 which provides that the only exceptions to the mandated rule under paragraph 5.1 others exemption set out in paragraph 5.2. Further the use of the NHS Standard Contract is emphasised at paragraph 12.1 of the Technical Guidance.
9.29 It follows that every CCG is under a public law legal obligation to use an NHS Standard Contract when placing a contract with a chosen provider following an IFR decision for an individual patient. It is therefore difficult to see that this part of the NHS England Guidance can possibly be correct because it fails to give effect to NHS England's own rules on the type of contracts that must be used by CCGs. The view is therefore put forward that the attempt by the NHS England Guidance to limit the type of contracts that count as "commissioning contracts" for establishing patient rights under Part 8 of the 2012 Regulations is wrong as a matter of law.
10 The general duties on CCGs and NHS England to commission services in accordance with preferences expressed by patients.
10.1 Section 13I of the NHS Act provides:
"The Board must, in the exercise of its functions, act with a view to enabling patients to make choices with respect to aspects of health services provided to them"
10.2 A like provision is imposed on CCGs by section 14V of the NHS Act 2006 which provides:
"Each clinical commissioning group must, in the exercise of its functions, act with a view to enabling patients to make choices with respect to aspects of health services provided to them"
10.3 This general duty is clearly not relevant where a patient seeks to establish a right to exercise patient choice under Part 8 of the 2012 Regulations. However, this duty is relevant to categories of patients who are outside the patient choice rights under Part 8 of the 2012 Regulations and to any request for funding for treatment that goes beyond an initial consultation.
10.4 Sections 13I and 14V impose procedural duties which require NHS England and each CCG to act at all times "with a view" to enabling patients to make their own choices about inter alia their selected healthcare provider. It is thus a general duty which applies to all commissioning decision-making processes by NHS England and every CCG. It therefore applies to CCGs when formulating general policies as well as when they are considering Individual Funding Requests.
10.5 A CCG has a legal duty to have regard to NHS England Guidance when making commissioning decisions in accordance with this duty. This duty is set out in section 14Z8 of the NHS Act which provides:
"(1) The Board must publish guidance for clinical commissioning groups on the discharge of their commissioning functions.
(2) Each clinical commissioning group must have regard to guidance under this section.
(3) The Board must consult the Healthwatch England committee of the Care Quality Commission-
(a) before it first publishes guidance under this section, and
(b) before it publishes any revised guidance containing changes that are, in the opinion of the Board, significant"
10.6 The December 2014 NHS England Guidance to CCGs provides at page 4:
"It is important to note that the right to choice does not mean that the patient only has their first outpatient appointment with their chosen provider: consistent with physical health care, once the patient has chosen a provider, that provider will normally treat the patient for their entire episode of care unless the patientÕs diagnosis changes significantly"
10.7 This is statutory guidance that each CCG must follow unless it has a good reason to depart from the Guidance. The courts scrutinise those "good reasons" carefully and they need to be very good reasons: see R (Fisher) v North Derbyshire Health Authority  EWHC Admin 675 and R (Rose) v Thanet Clinical Commissioning Group  EWHC 1182 (Admin). NHS England has no specific statutory duty to follow its own guidance but may well be acting irrationally if it has identical legal duties and yet fails to follow guidance it issues to CCGs about how the duties under the section are to be discharged.
10.8 However, sections 13I and 14V only impose procedural duties. It follows that there can be countervailing factors on which a CCG or NHS England could rely upon to reach a final decision which does not enable a patient to make choices with respect to aspects of health services provided to them. That raises the interesting question as to how a CCG or NHS England should approach a request for a provider to fund treatment which the CCG or NHS England has made a specific decision not to commission. The factors would have to be balanced in the decision making but it is probably lawful to override the patientÕs preference and to apply the general policy. It is not, however probably permissible to adopt a general policy not to fund any medical treatments where no specific decision has been taken to fund the form of treatment.
11 These legal structures probably mean that NHS England and CCGs can only discharge the duty by adopting a starting point that it should enable a patient to make choices with respect to aspects of health services provided to them, and then depart from that position if driven to do so by other factors. Some helpful guidance on the meaning of the section 14V duty can be drawn from the observations of Aitkens LJ in R (Brown) v Secretary of State for Work and Pensions  EWHC 3158 (Admin) which was concerned with the similarly worded "due regard" duty under section 149 of the Equality Act 2010. It follows that, in order to act lawfully:
i) Decision makers in a CCG and NHS England must record their awareness of the duty when making decisions. A CCG or NHS England decision maker will be in difficulties in asserting that he or she complied with this legal obligations in making a commissioning decision if the person who made the decision was not aware of the legal duty and/or made no reference to the legal duty in the decision making process;
ii) The mind of the decision maker must be focused on the duty during each stage of the commissioning decision making processes. Decision makers must have a Òconscious approach and state of mindÓ which is focused upon the legal obligation when they are taking commissioning decisions;
iii) The legal duty must be exercised in substance, with rigour and with an open mind;
iv) The duty is a nonÐdelegable duty;
v) The duty is a continuing duty throughout the commissioning process;
vi) It is good practice for those exercising public functions in public authorities to keep an adequate record showing that they had actually considered this duty and pondered relevant questions.
12 In summary therefore patient choice rights are powerful rights but are not generally well understood and are rarely exercised in practice. However, these legal rights are likely to become more important as NHS resources become tighter and patients are therefore increasingly denied treatment that they seek in order to balance the books.
David Lock QC
 The law stated in this chapter is with effect from 1 October 2016.
 There is a list of NHS bodies which have a legal duty to have regard to the NHS Constitution. It includes NHS England, CCGs, NHS trusts, NHS Foundation Trusts and local authorities exercising NHS functions. It does not include the Secretary of State but a like duty is imposed on the Secretary of State by section 1B of the NHS Act 2006.
 The original text of the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 is at http://www.legislation.gov.uk/uksi/2012/2996/contents/made but these Regulations have been amended on a number of occasions since they were made in 2012. References in this chapter are to the form of the 2012 Regulations in force in September 2016.
 This is the Regulation which requires a CCG and NHS England to have an Individual Funding Arrangement policy and to operate IFR panels. Where an IFR request is turned down the CCG or NHS England must give reasons: see Regulation 35.
 Or another person who can make a referral under Regulation 38.
This chapter has been updated in June 2014
Payment to GPs under Practice Contracts with NHS England.
This chapter contains:
1.1 The payment which is due to the service provider under a commercial contract is one of the key features of the contract. However in GP practice contracts payment terms are not straightforward. The payment obligation depends on the type of GP practice contract and on whether the services which the contractor agrees to provide are essential, additional or enhanced services. Further the payment terms (as well as other terms) are reviewed on an annual basis and, for those practices holding GMS contracts, can be changed by the unilateral action of a person who is not a party to the contract, namely the Secretary of State. Changes cannot be made to PMS agreements without the consent of the contract holder.
2.1 The sums due to a GP practice that holds a GMS contract are only partially set out in the GMS contract but are mainly set out in Directions made by the Secretary of State. The Direction are known as the General Medical Services Statement of Financial Entitlement Directions (“the SFE”). This document defines the amounts that are payable for essential, additional and enhanced services to GP practices that hold a GMS contract.
2.2 The legal basis for payments being set by directions is in section 87 of the NHS Act 2006 which provides as follows concerning payments to GP practices that hold a GMS contract:
2.3 Consideration of changes to the GP contract and the payment rates follows an annual cycle. The Secretary of State has delegated the job of negotiating the changes to GP contracts to staff at NHS Employers, who hold the consultations referred to in section 87(4). The “representative” tends to be the General Practice Committeeof the BMA. These discussions are often described as “negotiations” to seek to reach a common conclusion about changes to the GP contract and payment rates but, in law, this is a consultation. This means that the Secretary of State has to take due account of the views expressed by the GPC on behalf of working doctors but the Secretary of State remains as the ultimate decision maker. Hence the GPC can register its support or objection to a proposed change of terms but, once those consultations are completed, the Secretary of State makes the final decision. The Secretary of State then issues Directions which set out the changes to the existing SFE that affect GMS practices will be paid in the coming year.
2.4 In 2013 the Secretary of State revised the SFE and published an entirely new document rather than making Directions which contained reference to previous versions. The 2013 SFE can be accessed here. The 2013 Directions document runs to 141 pages. It is beyond the scope of this website to seek to describe every aspect of the payment system but it builds on previous structures. In 2014 the Secretary of State published Directions which built upon and amended the 2013 Directions. The 2014 amending Directions can be accessed here. It follows that the sums payable to a GMS practice in 2014 are set out in the 2013 SFE as amended by the 2014 SFE.
2.5 The Directions take effect as a term of the GMS contract by clause 18.1.2 (of the standard GMS contract published by NHS England) which provides:
2.6 Thus the Directions made by the Secretary of State form a term of the GMS contract. The contract also includes “set off” provisions under which NHS England are entitled to set off any sums which are due to NHS England from the contractor against any sums payable under the Directions. All payments must be made promptly by NHS England under clause 18.1.1. which provides:
2.7 In practice payments are made monthly by NHS England to GMS practices.
3.1 The power to set up different types of commercial arrangements with GP practices was first set out in the NHS (Primary Care) Act 1997. That power is now included in the NHS Act 2006 (as amended by the Health and Social Care Act 2012). These new forms of agreement were originally temporary but were made into permanent agreements in 2004. Section 94 of the NHS Act provides that the Secretary of State can make Regulations about the terms to be included in PMS agreements. Section 94(4) then provides:
3.2 Regulation 13(1) of the PMS Regulations 2004 provided that PMS agreements were required to contain a term that payments were to be made in accordance with Directions issued by the Secretary of State. That Regulation reads as follows:
3.3 This statutory scheme appeared to envisage that the Secretary of State would make directions to set out the payments due to PMS practices in the same way as directions were made for GMS practices. However the Secretary of State has not made any Directions which fix the sums that PMS contractors are required to be paid for the provision of essential services because these remain a matter for local negotiation. The Secretary of State retains a power to issue directions which would define the sums that would be paid to PMS practices but, at this point, there is no evidence that the Secretary of State has contemplated using that power. The sums payable thus continue to remain a matter for negotiation between NHS England and PMS practices.
3.4 The Secretary of State issued directions in 2013 to PMS practices which cover payments due to doctors working on the Flexible Careers Scheme, the Returners Scheme and the Doctors’ Retainer Scheme, all of which were designed to keep as many GPs as possible working within the NHS. These Directions are accessible here.
3.5 However Directions have been made which refer to the payments that are to be made for the following Enhanced Services provided by PMS practices:
a) Extended Hours Access Scheme;
b) Alcohol Related Risk Reduction Scheme;
c) Learning Disabilities Health Check Scheme;
d) Childhood Immunisation Scheme;
e) Violent Patients Scheme;
f) Minor Surgery Scheme;
g) Patient Participation Scheme;
h) Dementia Scheme; and
i) Avoiding Unplanned Admissions and Proactive Case Management Scheme.
3.6 In each case the PMS Directions set out the type of conditions that must be considered when NHS England is entering into a PMS contract for each of the above schemes with a PMS practice. However, unlike the GMS Directions, when it comes to payment the Directions do not fix the sums that a PMS practice are to be paid if the practice agrees to participate in any of the above schemes. The Directions say that in determining the amount to be paid by NHS England to the practice, NHS England must “have regard to” the sums paid under the relevant part of the GMS Directions. The phrase “have regard to” means that the payments under the GMS Directions must be a starting point for any negotiations between the PMS practice and NHS England for the provision of an Enhanced Service but allows NHE England and the PMS practice to agree a higher or lower sum to be paid for the provision of the service.
3.7 If the practice and NHS England were unable to agree the amount to be paid to a PMS practice for an additional service then theoretically NHS England would be able to define the sum that was to be paid and, if the PMS practice wished to continue to provide the service, it would have to accept the sum that was stipulated by NHS England. However, in that case, NHS England would need to have considered the sum payable under the SFE for the provision of the services and to have justifiable reason for departing from that sum in the PMS agreement with the practice.
3.8 The absence of directions to cover essential services and terms such as premises costs means that PMS contracts need to be read carefully to determine the payments due without necessarily any reference to the equivalent GMS terms. A large number of PMS agreements define that the sums paid to the practice will be fixed by reference to the SFE. If this is the case then, as the terms of the SFE are varied each year, so the terms of the PMS contract are varied. However in the absence of an express term incorporating the SFE as a term of the PMS agreement, in principle, terms agreed for GMS contracts will only apply to PMS agreements if there is a written agreement between the parties that varies the contractual terms to incorporate the new term.
3.9 In this context it is particularly relevant whether the PMS agreement has an “entire agreement” clause. Although no standard PMS agreement was produced by the Department of Health, many of the forms of PMS agreement used by PCTs (and the contract promoted by the BMA) contained an “entire agreement” clause. This clause provides that the written document contains the entire agreement between the parties and thus makes it very difficult if not impossible to allege that implied terms should supplement the terms of the written agreement.
3.10 An example of the way this works is shown in the FHSAU decision 15512. In this case a PMS contractor sought to change the basis of its premises payment from a Cost Rent basis to a Notional Rent basis, in accordance with the National Health Service (General Medical Services - Premises Costs) (England) Directions 2004. However these 2004 Directions only apply to GMS contracts and not PMS agreements. The PCT refused to change the basis of the premises payment and referred to an “entire agreement” clause in the contract. The PCT thus disputed that the PMS practice was entitled to rely on the 2004 Directions. The FHSAU sided with the PCT saying
3.11 Thus the sum to be paid for premises under this agreement was fixed by the agreement itself. The position was repeated in FHSAU casedated 29 June 2010 where the FHSAU said:
3.12 Thus the payment terms within a PMS agreement are set out in the written document itself and in any subsequent written agreement and cannot be set by reference to the equivalent GMS terms.
4.1 APMS contracts are awarded by NHS England exercising its general powers under section 83(2) of the NHS Act. There is no provision for the Secretary of State to make Directions to govern payments under such contracts. It follows that the payment terms must be governed by the terms of any such contract (as varied by agreement between NHS England and the contractor from time to time).
5.1 The standard GMS contract commits NHS England to making payments to a contractor “promptly and in accordance with both the terms of the Contract”: see clause 18.1.1. If payments are not made by NHS England to a GP practice then the GP practice can either register a dispute with the FHSAU or, if it is a legally binding contract, sue NHS England for the monies owing in the county court.
5.2 If the practice obtains a determination from the FHSAU that monies are owing by NHS England to the practice (or NHS England obtains a determination that monies are owing by the practice to NHS England) then NHS England comes under a statutory duty to pay the monies determined to be owing. The legal route by which NHS England comes under that statutory duty is not wholly clear. When NHS Contracts were first defined in legislation by section 4 of the National Health Service and Community Care Act 1990, section 4(7) provided:
5.3 This provision set up a clear statutory duty on the NHS body to pay the monies owing as a result of any determination made by the Secretary of State (or made by the FHSAU on his behalf). Hence a GP practice that was not paid sums owing under a determination could rely on the statutory duty under section 4(7) to commence proceedings in the county court. This position was reflected in paragraph 96(2) of the PMS Regulations 2004 which provided that PMS Agreements were to have the following terms included in the agreement:
5.4 However there was no equivalent in the GMS Regulations and the clear statutory duty in the 1990 Act does not appear to be replicated within section 9 of the NHS Act 2006 which made provision for NHS contracts. However the practice of the FHSAU is to anticipate that, once a determination is made in respect of an NHS contract which provides for sums to be owing, it can be used by either party to bring proceedings in the county court.
 I would like to extend thanks to Michael Rourke of Lockharts Solicitors who provided valuable feedback on an earlier draft of this chapter. However I bear sole responsibility for the final text (subject to the terms of the site).
 Please see chapter 7 of this Guide which explains the meaning of essential, additional and enhanced services.
 References in Regulations to “the Board” are references to NHS England.
 Although a PMS agreement can be a legally binding contract they are usually referred to as “agreements” rather than contracts because the default position is that a PMS agreement is an NHS contract rather than a legally binding contract.
 This was a reference to the relevant provision in the NHS Act 1977 as imported into that Act by the NHS (Primary Care) Act 1997. The relevant provision is now in section 94 of the NHS Act 2006.
 Please see chapter 7 of this website for a description of the services that all standard general practice contracts are required to provide.
 For more details on the effect of an entire agreement clause in a GP practice contract please see paragraph 11 of chapter 3 of this website.
Breaches of GP practice contracts, Remedial and Breach Notices
and termination of GP Practice Contracts.
This Chapter contains:
Summary: This chapter examines what happens if a GP Practice acts in breach of the terms of a GO Practice Contract, the notices that NHS England can serve on the GP Practice if there is a breach, the consequences of such a notice and the circumstances in which both the GP Practice and NHS England are permitted to terminate a GP Practice contract.
1.1 A GP practice contract is a legally binding agreement under which the GP practice takes on a large number of obligations, although primarily to deliver primary care services to NHS patients, and NHS England agrees to make payments to the GP practice in accordance with the contract. Although, to a great extent, the terms of a GMS or PMS contract is prescribed by Regulations, once the contract has been signed it takes effect as a normal commercial contract between the parties. The position was explained by Hickinbottom J in Tomkins v Knowsley Primary Care Trust  EWHC 1194 (QB) who said at §8:
“.. once a contract  had been agreed between the PCT and a dentist, it took effect as an ordinary contract, enforceable as such”
1.2 The rights and obligations of both the contractor and NHS England are set out in the wording of the GMS or PMS contract and it takes effect as a normal contract between the parties. That document defines the totality of the rights and obligations of both parties and defines how each party is entitled to react if there is a breach of contract by the other party (for more details see chapter 3). For the purposes of this chapter it is rarely relevant whether the GP practice has an NHS contract or a legally binding contract. Please click here for an explanation of the differences between an NHS contract and a legally binding contract. The only difference is that a dispute about the termination of an NHS Contract can only be raised within the NHS Disputes Resolution process.
1.3 The scheme described in this chapter is based around a General Medical Services Contract (“GMS”)  contract. Personal Medical Services (“PMS  ”) and Alternative Personal Medical Services (“APMS”) contracts ought to have an largely identical scheme for breaches and termination because the relevant parts of the GMS Regulations are replicated in the PMS Regulations.
1.4 There are a large number of obligations that GP practices take on within a practice contract. NHS England is thus entitled to require GP practices to perform all of the obligations. Thus, for example, the practice is obliged to be open for core hours as defined in the GMS Regulations. Christmas day is excluded from core hours but the practice must be open on Christmas Eve. A practice that fails to provide services to NHS patients on either Christmas Eve would be acting in breach of contract and NHS England would therefore be entitled to take enforcement action against the practice for that breach.
1.5 However NHS England is rarely able to terminate a GP practice for a single breach of contract of that type. The contract sets out a scheme under which NHS England is entitled to respond to breaches of contract in a measured and proportionate way. This scheme requires the contractor to respond appropriately to an alleged breach. The scheme seeks to avoid unnecessary confrontation and to manage the relationship between the contractor and NHS England in a sensible way. However a contractor which does not co-operate with NHS England by responding appropriately to action by NHS England under the contract can find that his, her or its contract is lawfully terminated.
 The Tomkins case concerned a dental contract but the same principles apply to a GP medical contract.
 GMS stands for “General Medical Services”. It is the default form of agreement for GP practices. For details of the different types of contracts that a GP practice can hold please see chapter 3. The original Regulations setting up GMS contracts were the National Health Service (General Medical Services Contracts) Regulations 2004. These Regulations are at http://www.legislation.gov.uk/ssi/2004/291/contents/made However the www.legislation.gov.uk website has not been updated to show all the changes made by the numerous amending regulations made since the Regulations were introduced in 2004. The wording quoted in this chapter is the version which is current at 1 January 2014 when this chapter has been written.
 PMS stands for “Personal Medical Services”, a form of GP Practice contract originally brought in by the National Health Service (Primary Care) Act 1997. For details please see chapter 3. The original PMS Regulations are the National Health Service (General Medical Services Agreements) Regulations 2004. These Regulations are at http://www.legislation.gov.uk/ssi/2004/619/contents/made However the www.legislation.gov.uk website has not been updated to show all the changes made by the numerous amending regulations made since the Regulations were introduced in 2004. The wording quoted in this chapter is the version which is current at 1 January 2014 when this chapter has been written.
When can fees be charged to a patient by a GP Practice? (Extract)
This chapter contains:
1.1 NHS services are generally free at the point of use for patients. However the NHS has always imposed charges for some healthcare services and there are other functions undertaken by NHS doctors which are outside their NHS duties and hence attract a fee. It follows that full legal position is somewhat more nuanced. The general requirement that services should generally be provided free of charge is set out in section 1(4) of the National Health Service Act 2006 (“the NHS Act”) which provides:
“The services provided as part of the health service in England must be free of charge except in so far as the making and recovery of charges is expressly provided for by or under any enactment, whenever passed”
1.2 There are a number of areas where Regulations provide that charges may be imposed for NHS services including:
b) Dental services;
c) Optical services;
d) Contraceptive services;
e) Hospital services for persons who are not usually ordinarily resident in the UK.
1.3 Primary care services provided under a GMS or PMS contract to patients on the practice list or temporary residents are required to be provided free of charge. The GMS and PMS contracts also provide that GP practices have a contractual obligation to provide a range of other services to patients. However GP practices are (almost all) private sectors businesses that have contracted with NHS England to provide defined primary care services to a defined group of patients and to provide defined level of emergency medical services in limited circumstances. If a registered patient or temporary resident seeks primary care services from an NHS GP practice outside the terms of the contract held by that practice, the NHS GP practice has no obligation to provide services to that person. However the GP practice cannot charge for treatment provided outside the GP Practice contract unless the service falls within a limited categories of specific services.
 GMS stands for “General Medical Services”. It is the default form of agreement for GP practices. For details of the different types of contracts that a GP practice can hold please see chapter 3.
 PMS stands for “Personal Medical Services”, a form of GP Practice contract originally brought in by the National Health Service (Primary Care) Act 1997. For details please see chapter 3.
 Please see chapter 7 for details of the range of services that a GMS or PMS practice is obliged to provide.
 Please see chapter 6 for details about how GP practice lists work and the persons to whom a GP is obliged to provide services.
The services an NHS GP Practice is obliged to provide to patients (Extract)
This Chapter contains:
4. Core hours.
1.1 This chapter seeks to identify which medical services GP Practices are obliged to provide as part of NHS funded treatment and where a GP is entitled to refer a patient to another NHS provider. Section 83 of the National Health Service Act 2006 (“the NHS Act”) provides:
“The Board must, to the extent that it considers necessary to meet all reasonable requirements, exercise its powers so as to secure the provision of primary medical services throughout England”
1.2 “The Board” in the above section is a reference to the National Health Service Commissioning Board, known as NHS England. The Board is referred to within this chapter as NHS England but citation from statutes refer to it as “the Board”. Section 83(1) means that NHS England is under a statutory duty to secure the provision of primary medical services throughout England. Sections 83(5) and (6) provide:
“(5) Regulations may provide that services of a prescribed description must, or must not, be regarded as primary medical services for the purposes of this Act.
(6) Regulations under this section may in particular describe services by reference to the manner or circumstances in which they are provided”
1.3 The relevant regulations under section 83 are the National Health Service (Primary Medical Services) (Miscellaneous Amendments and Transitional Provisions) Regulations 2013 (“the 2013 Regulations”). However several sets of Regulations were made under the statutory predecessors of section 83 which remain in force to the extent that they have not been amended by the 2013 Regulations.
1.4 The 2013 Regulations make extensive changes to the National Health Service (General Medical Services Contracts) Regulations 2004 (“the GMS Regulations) and the National Health Service (Personal Medical Services Agreements) Regulations 2004 (the “PMS Regulations”). These Regulations define the contents of GMS and PMS contracts (and have been updated on numerous occasions since they were first published). There are no Regulations for APMS contracts but the form of these contracts usually follows the GMS/PMS model, with amendments made to the model as required.
1.5 The current definitions of what are and are not “primary medical services” for the purposes of section 83 are contained within the GMS Regulations. These Regulations define the services that those delivering primary care within the NHS are obliged to provide. These definitions take effect as terms of practice contracts with NHS England held by GP practices. The definitions of primary medical services include:
a) essential services;
b) additional services;
c) enhanced services; and
d) emergency services.
 The electronic version of the National Health Service Act 2006 on the www.legislation.gov.uk website has not yet been updated to show all the changes to the 2006 Act made by the Health and Social Care Act 2012. Hence the present publicly accessible version of section 83 at http://www.legislation.gov.uk/ukpga/2006/41/section/83 still refers to the duty to provide primary care services being a duty resting on primary care trusts.
 Under the NHS Act 2006 as originally passed this duty rested on primary care trusts. It was transferred to NHS England in April 2013 as a result of amendments made in the Health and Social Care Act 2012.
 Transitional provisions mean that Regulations made under the equivalent of section 83 in the National Health Service Act 2006 continue to have effect./
 The electronic version of the National Health Service (General Medical Services) Regulations 2004 on the www.legislation.gov.uk website has not yet been updated to show all the changes made by the numerous amending regulations made since the Regulations were introduced in 2004. The original Regulations are at http://www.legislation.gov.uk/ssi/2004/115/contents/made but the wording quoted in this chapter is the version which is current at 1 January 2014 when this chapter has been written.
Management of the Practice list of patients (Extract)
This chapter contains:
1.1 GP services are the building block of NHS services because, other than attendance at an Accident and Emergency Department of an NHS hospital, the GP is the gateway by which the vast majority of NHS services are accessed by patients. However the provision of all medical services to patients only usually occur where the patient seeks those services from a GP practice where the patient is registered (although GP practice must provide services to other persons as set out below). There is no obligation on anyone living in England to register with an NHS GP practice. This is a matter of free choice for each individual. But the patient can only generally access services by first getting themselves registered with a local GP practice.
1.2 The legal duty for the NHS to commission GP services rests on the National Health Service Commissioning Board, known as “NHS England”. Section 84 of the National Health Service Act 2006 (“the NHS Act”) provides that NHS England is required to set up “arrangements” so as to provide primary medical services throughout England “to the extent that it considers necessary to meet all reasonable requirements”.
1.3 The wording of the statutory duty means that there is no absolute legal requirement on NHS England to ensure that every individual is able to register with a GP practice which is local to their home. The duty is to set a network of GP services to meet the reasonable requirements of patients, and what is reasonable will depend in part on the resources available to NHS England.
1.4 There are occasions when a person cannot find a GP who is prepared to admit that person to their list (either as a registered patient or as a temporary patient). There can be many reasons why an individual patient may find it difficult to find a place on a GP list of a local practice. There are very occasional circumstances where all local GP practices are full and have closed their lists. In such circumstances NHS England will probably have a duty to secure additional GP services in the area to meet its duty under section 84. However the more common reason why a person finds difficulty in registering with a GP practice is because that person has previously been removed from lists of other GP practices in the area for being violent, offensive or for another permissible reason. Most NHS areas have a reserve facility to provide GP services to patients who have been excluded from the lists of other practices. The details of removal and its consequences are explored below.
1.5 The fact that a patient is having difficulty finding a GP will not usually, of itself, be sufficient to demonstrate a breach by NHS England of their duty under section 84. A breach of the section 84 duty would only be established if NHS England had failed to make a proper assessment of the level of local need for GP services in an area or had not produced a plan to deliver services to meet the identified needs. NHS England cannot form a judgment as to whether it is delivering on its duty to provide services to meet the reasonable requirements of the local population for GP services unless it has knowledge of the needs of the population for those services. That knowledge could be based on a needs assessment or could be judged by the number of practices who are open to new patients in an area (and the number of registered patients per GP).
1.6 NHS England’s role is to commission a GP practice to deliver services to NHS patients. Once the commissioning contract is in place the onus shifts to the relationship between the GP and the individual patient because a doctor/patient relationship will only work if there is a measure of trust on both sides. The patient has to have confidence in the medical practice and, if the patient does not have that confidence, the statutory scheme allows the patient to leave the practice and register with another medical practice. However a measure of trust is also required the other way – namely from the doctor to the patient. This can be a very delicate area in practice because there are conflicting interests. On the one hand the NHS ought not to foist a patient on a GP with whom the practice cannot build any form of therapeutic relationship. On the other hand GPs are delivering public services and so should have a duty to work with any member of the public who wishes to access their services. Teachers and social workers cannot, for example, pick and choose the members of the public to whom they are obliged to provide public services as part of their occupation (paid for by taxpayers money). GPs should certainly not be able to react to complaints by removing a patient from their practice list.
1.7 This chapter explores the legal rules which apply to doctors admitting patients to their lists, removing patients from their lists and the powers of NHS England to force an NHS GP practice to take a patient onto the practice list.
 There are limited exceptions to this approach, particularly for services for those suffering from Sexually Transmitted Diseases. STI clinics can be accessed by patients without a referral from their GP.
GPs and the law on commissioning NHS services (Extract).
This chapter contains:
1.1 There are many definitions of the word “commissioning”. The NHS Improvements Website describes commissioning the achievement of high quality and value-for-money services for the NHS. It states:
“Commissioning is a cycle of activities that includes assessing the needs of a population; analysing 'gaps'; setting priorities and developing commissioning strategies; influencing the market to best secure services and monitoring and evaluating outcomes. In other words, it involves buying in services from a range of health service providers (including GPs, dentists, community pharmacists, NHS and private hospitals, and voluntary sector organisations) to meet the health needs of local people, and monitoring how well they are being delivered. Commissioning is an on-going process that applies to all services, whether they are provided by the local authority, NHS, other public agencies, or by the independent sector”
1.2 The placing of contracts with a provider is thus the final act of the procurement stage of the commissioning process. The contract is the last step in a long sequence of events that ought to take place before the decision is made by the CCG that the NHS ought to contract for any specific service. However commissioning is a continuing process because, after the contract has been placed, the commissioner is then responsible for monitoring the performance of the contractor.
1.3 Hence commissioning process is thus complex. This chapter describes some of the legal challenges which arise in the commissioning process. It also contains an outline as to how NHS bodies are able to make lawful commissioning decisions. The model will not be followed by every CCG in every case, but the steps which are set out below are the essential building blocks of a lawful commissioning process.
1.4 Commissioning is challenging for GPs who want to do the best for their patients because the demand for clinically effective healthcare treatment for individual patients (suffering from both common and rare medical conditions) vastly exceeds the ability of the NHS to fund such treatment. NHS bodies have a finite budgets and this means that difficult choices have to be made about how services are organised and structured and, in the end, which drugs and other treatments can and cannot be provided to patients suffering from both common and rare conditions. Once it is recognised that choices have to be made as to which treatments the NHS can afford to provide to patients, it is a legal necessity that the process of making those policy choices should be transparent and rational.
1.5 Section 1 of the National Health Service Act 2006 imposes a duty on the Secretary of State to continue the promotion of “a comprehensive health service”. Some patients and clinicians rely on this section to argue that the NHS is obliged to provide them with a comprehensive service and so argue that rationing NHS services is inherently unlawful. However inevitably it is not that straightforward. Section 1(1) of the NHS Act provides:
“The Secretary of State must continue the promotion in England of a comprehensive health service designed to secure improvement—
(a) in the physical and mental health of the people of England, and
(b) in the prevention, diagnosis and treatment of physical and mental illness”
1.6 The Court of Appeal decided in that the “duty of promotion” on the Secretary of State was not a duty to provide a comprehensive health service. The Court accepted that budget considerations may mean that the Secretary of State could never in fact provide a service that was truly comprehensive, in that it provided services to meet all healthcare needs. The court decided that the section meant the Secretary of State was required to use his or her powers to focus on providing as comprehensive a service as the NHS budget would permit, recognising that the NHS may never get to that state of healthcare nirvana.
1.7 In Coughlan the Court of Appeal was considering the wording of section 1(1) in the NHS Act 1977. The only change since that time is that is the Health and Social Care Act 2012 changed the words in sub-section (b) from “illness” to “physical and mental illness”. “Illness” already had a wide definition in section 275 of the NHS Act which states that “includes mental disorder within the meaning of the Mental Health Act 1983 and any injury or disability requiring medical or dental treatment or nursing”. This change accordingly appears to make no difference at all, save that it emphasises that the NHS has a duty to provide mental health services as well as services to meet physical illnesses.
1.8 So what is the legal effect, if any, of the duty on the Secretary of State to “continue the promotion in England of a comprehensive health service”? The practical answer is that this section has little if any legal effect because it is difficult to imagine any set of circumstances in which the decision is required to be different because the Secretary of State has the section 1 duty. There has been no court case concerning reorganisation of NHS services or access to NHS funded medical a treatment which (and there have been many) which, as far as I am aware, has criticised the Secretary of State for failing to discharge the section 1 duty.
1.9 The Court of Appeal in noted that the Secretary of State has a duty to continue the promotion in England of a comprehensive health service. The court then said:
“His duty under section 3 is subject to the qualification that his obligation is limited to providing the services identified to the extent that he considers that they are necessary to meet all reasonable requirements. He does not automatically have to meet all the requirements and in certain circumstances he can exercise his judgment and legitimately decline to provide them. In exercising that judgment he is entitled to take into account the resources available to him and the demands on those resources”
1.10 It is therefore clear that the Secretary of State does not have a statutory duty to deliver a comprehensive health service. NHS commissioners are required to remain focused on the fact that the Secretary of State has a duty to promote the delivering of a comprehensive health service remains the ultimate aim of the NHS even if that is unachievable in practice.
1.11 The real world of restricted budgets (which is fully recognised by the courts) means that lawful commissioning needs to focus on how decisions are made. Commissioning is concerned with the process by which decisions are made in the NHS because, whenever a decision is made, there will be winners and losers. There will be patients and clinicians who secure the funds for the services they have been seeking and there will be those that are disappointed (and often angry) and feel that the wrong decision has been taken. The focus of this chapter will therefore be on the process of taking decisions and the challenges of ensuring that the decision making process is legally robust.
1.12 The NHS has a Constitution to which all NHS bodies, including Clinical commissioning Groups (“CCGs”) are required to “have regard to the NHS Constitution”: see section 2 of the Health Act 2009. The duty to “have regard” to the NHS Constitution during a decision making process means that the CCG is obliged to understand the terms of the NHS Constitution and act in accordance with the principles set out in that document unless it has a very good reason to depart from those principles. The relevant part of the NHS Constitution on commissioning provides:
“The NHS commits to make decisions in a clear and transparent way, so that patients and the public can understand how services are planned and delivered.”
1.13 Hence, throughout the commissioning process, there is a need for CCGs to act in a clear and transparent way, and to ensure that they can defend their reasoning at all times within the commissioning decision making process. It also ties in to the central importance of public participation in the commissioning process which is considered at chapter 11 below.
Managing conflicts of interest for GPs (Extract).
This chapter contains:
1.1 Managing actual or potential conflicts of interest is essential for every professional. General Practitioners are in no different position to lawyers, accountants or many other professionals who ply their professional trade for the benefit of clients but, to a greater or lesser extent, are not paid by clients but by a third party (and often the government). No professional can avoid conflicts of interest, every professional must be acutely aware of them, understand how differing interests are seen by others and act in a professional manner to manage these interests properly. This is far from easy for all professionals but the present NHS structures have created particularly difficult issues around conflict of interests for GPs.
1.2 NHS England has published Guidance concerning the management of conflicts of interest. It explains their understanding of a conflict of interest as follows:
1.3 Helpful guidance on identifying what is meant by a conflict of interest is also set out in a Paper prepared by the NHS Confederation and the Royal College of General Practitioners dated September 2011. This defined a conflict of interest as follows:
1.4 It is impossible to describe and provide guidance about every single all factual situation which might give rise to a conflict of interest for GPs in practice. The arrangements which have been set up the government which involve GPs in commissioning will inevitably involve GPs in many situations where they potentially have more than one interest in a proposed decision. However it is important to remember that conflicts of interest can never be eliminated. They existed for GPs before the creation of CCGs (in particular under the old fundholding system) are an inevitable feature of all professional practice.
1.5 Hence the key requirements for GPs are to identify where conflicts arise and to make sure that these are properly disclosed and registered, and then managed in accordance the arrangements that CCGs have put in place are the proper disclosure and management of actual and potential conflicts.
1.6 Every GP Practice which holds an NHS practice contract is required to be a member of the local Clinical Commissioning Group (“CCG”) : See section 14A(1) of the NHS Act. The constitution of the CCG will define how members of a practice can become involved in the workings of the CCG, stand for election to its committees and otherwise become involved in its work. There is an obvious potential for conflicts of interest where a GP practice, which is a member of a CCG, bids for a contract where the NHS commissioner is the local CCG.
1.7 However there are many other circumstances where a GP, acting perfectly properly, may become involved in a situation where a conflict of interest or potential conflict of interest arises. Many GPs are also shareholders, directors, employees or partners in medical or social care businesses that provide medical services to NHS patients or provide primary medical services to such businesses. These businesses may have contracts with NHS commissioners. There is a potential conflict of interest if any of these businesses tender for a contract with the CCG of which the GP is a part.
1.8 There can be both legal and professional consequences for a GP who fails to recognise and properly manage a conflict of interest. However managing conflicts of interest is part of the professional duties of a GP as the Royal College of GPs and NHS Confederation observed in their Paper in September 2011:
1.9 Issues around conflicts of interest do not usually arise with general practice contracts (i.e. GMS, PMS and APMS contracts) because those contracts are awarded and managed by NHS England and not by the local CCG. However local GP practices, either individually or through consortia, are in a prime position to contract for the delivery of a large number of services in addition to those governed by GMS, PMS and APMS contracts. These are very often contracts which are let by the local CCG, whose members are the local GP practices. The transfer of NHS services out of hospital settings and into the community over the coming years means that the volume of such contracts is certain to increase and hence managing the actual and potential conflicts of interest inherent in such arrangements will become a problem that GPs, CCGs and those who advise them will need to focus on with particular care.
1.10 The legal obligations on practising doctors concerning conflicts of interest arise in a number of different ways. There are provisions of the GMC Code about managing conflicts of interest (which are set out below). There are also provisions in both the NHS Act (as amended by the Health and Social Care 2012) and the in National Health Service (Procurement, Patient Choice and Competition) (No. 2) Regulations 2013 (“the 2013 Regulations”) around managing conflicts of interest. Rules for managing conflicts exist within CCG constitutions and standing orders and guidance on this subject has also been given by both NHS England and Monitor. Much of this Guidance from different bodies covers the same grounds.
1.11 It follows that all GPs who are working the NHS must have a working understanding of the concepts that lie behind managing conflicts of interest and have a legal and professional duty to ensure that they know and abide by the national and local rules to manage potential conflicts. Obligations of openness and proper management of conflicts of interest have been imposed on elected councillors and local government officers for many years. These rules are, to a large extent, an inevitable consequence of their roles within a tax payer funded public service. The rules referred in this chapter impose similar obligations on those working in the NHS. Whilst GPs may resent the level of openness that properly managing conflicts inherently entails, doctors (and CCG staff) have to take difficult decisions about how tax-payers monies are spent and what services are received by NHS patients. Patients pay the taxes that fund the service. The openness about decision making required by the present arrangements is part of the system under which those who make public service decisions are accountable to their paymasters for the decisions that are made.
GPs and Practice Contracts with NHS England (Extract).
This chapter contains:
· GMS Contracts
· PMS Contracts
· APMS Contracts
· The present status of former 1997 pilot scheme contracts (as varied in 2004)
1.1 Unlike doctors working in hospitals, General Practitioners have never been required to be employees of the NHS. General practices operated as private sector businesses prior to World War II, with many patients covered by insurance schemes. As a result the British Medical Association rejected the government’s original proposal that GPs should become local authority employees and argued that they should remain as self-employed individuals, contracting into the new NHS as required. This reality was accepted by the Minister for Health, Rt. Hon Aneurin Bevan, MP, and thus when the NHS was set up in 1949 (as a result of the National Health Service Act 1946) general practices continued without the doctors being required to become NHS employees. GPs remained as self-employed professionals and were originally paid a fee by the NHS for every patient on their practice list.
1.2 Although there have been various experiments with directly employed GPs working for the NHS in general practice operated by NHS Trusts, the vast majority of GP practices are not staffed by doctors who are employees of the NHS. Increasingly however there can be a distinction between the GPs who provide professional services to NHS patients and the individuals who own the medical practices within which those services are delivered.
2.1 Section 29 of the National Health Service Act 1977 provided that Health Authorities were required to “arrange as respects their area with medical practitioners to provide personal medical services for all persons in the area who wish to take advantage of the arrangements”. Thus, under the NHS 1977 Act (and the NHS Act 1946 which preceded it), GP practises were licensed by the NHS and were paid for treating NHS patients under a statutory scheme. The terms of service for GPs were set out in Regulations and the payment scheme was governed by Directions made by the Secretary of State. This scheme was known as “General Medical Services” and, at the time, was the only mechanism under which GPs could provide primary care services for NHS patients.
2.2 In 1991 the Conservative government created the division between “purchasers” and “providers” in the NHS. The legislation which brought this about was the National Health Service and Community Care Act 1990. It created two models of commissioning – one based on health authorities, and the other based on general practice. General practices were encouraged to become commissioners through a route known as “fundholding”. This meant that the GP practice held the budget that was used to commission secondary care for the patients of the practice.
2.3 Under GP fundholding GPs held real budgets with which they purchased primarily non-urgent elective and community care for patients; they had the right to keep any savings and had the freedom to deliver new services. The aim was to give GPs a financial incentive to manage costs and to apply some competitive pressure to hospital providers. Some GP practices came together in consortia, creating larger organisations to pool financial risk and share resources. From 1994 the total purchasing pilot scheme (TPP) allowed general practices – either individually or in groups – to commission all services for their patients, though most were highly selective in what they chose to purchase. TPPs acted as sub-committees of health authorities and used an indicative, rather than a real, budget. However the payment to the GPs for their own work continued to be under the general statutory scheme. Section 29(4) provided somewhat cryptically that payment to a GP:
“… shall not, except in special circumstances, consist wholly or mainly of a fixed salary which has no reference to the number of patients for whom he has undertaken to provide such services”
2.4 The details of the payment to GPs was set out in the annual “Statement of Fees and Allowances” (“SFE”). This is a Direction made by the Secretary of State every year which sets out the sums that GP practices are entitled to be paid for every aspect of their work. The 2013 SFE can be accessed here.
2.5 The Labour government abolished GP fundholding in 1997 but retained the purchaser/provider split. However just before the 1997 general election Parliament passed the National Health Service (Primary Care) Act 1997. This introduced a new form of “arrangement” for primary care contracting called a “personal medical services” (“PMS”) contract. The original PMS agreements were pilot agreements which were only designed to last for a limited period. There was no standard PMS contract because the idea was to allow local health authorities to be flexible in agreeing new ways of working with innovative GPs. A doctor who provided GP services to NHS patients under a PMS agreement was not permitted to deliver General Medical Services.
2.6 The 1997 Act brought in powers to amend the NHS Act 1977 to allow Health Authorities to enter into permanent PMS contracts. However that power was not implemented until March 2004.
2.7 The transition from pilot agreements to PDS agreements was not a straightforward process, the details of which are the subject of a present case before the Court of Appeal (Pitalia v NHS England which is due to be heard in early 2014). However by 2004 the government had decided that all GP practices should have contracts with their local NHS commissioners (who were Primary Care Trusts at that stage). This signalled an end to GPs being paid under a statutory scheme. It follows that the primary legal relationship between the NHS commissioner and the GP ceased to be based on statutory duties and became a contractual relationship.
Providers of NHS services.
Regulators of NHS services.