Introduction

1. The Health and Care Act 2022 (‘the 2022 Act’) amended the NHS Act 2006 and gives NHS England powers to oversee and take enforcement action in relation to ICBs’ compliance with patient choice requirements.

2. Patient Choice requirements are set out in Part 8 of the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 (‘the NHS Standing Rules’) – as amended, including by the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) (No. 2) Regulations 2023. These rules are the source of patients’ rights to choose certain aspects of their healthcare as described in the NHS Choice Framework. They set out ICBs’ responsibilities in relation to patient choice and obligations in relation to the qualification of providers for services where legal rights to choice apply or choice is otherwise offered on an unrestricted basis. ICBs’ obligations in relation to both patient choice and the qualification of providers are referred to collectively as “patient choice requirements” in this document.

3. The authority to take enforcement action with ICBs in relation to patient choice requirements sits with NHS England. This document, which is published as an annex to the NHS England Enforcement guidance, outlines how NHS England intends to exercise those enforcement powers.

4. This guidance should be read alongside the Patient choice guidance which provides operational guidance to ICBs, Providers and Primary Care on the patient choice requirements and explains how the patient choice requirements should be implemented.

5. In keeping with a system-led approach, NHS England will discharge its duties through dialogue with ICBs wherever possible, offering the ICB advice and encouraging it to resolve issues locally before escalation.

Legislation in relation to ICB failure to comply with patient choice requirements

6. NHS England has specific powers to investigate whether an ICB has failed/is likely to fail to comply with patient choice requirements under the NHS Standing Rules.

7. Section 6F of the NHS Act 2006 gives NHS England the power to:

1. investigate whether an ICB has failed or is likely to fail to comply with a patient choice requirement
2. direct an ICB: (a) to put in place measures for the purpose of preventing failures to comply with patient choice requirements or mitigating the effect of such failures, or (b) where an investigation as mentioned above has been conducted, to remedy a failure to comply with patient choice requirements; and
3. where an investigation as mentioned above is being or has been conducted, accept from the ICB an undertaking that it will take any action falling within (ii) above that is specified in the undertaking, within a period that is so specified.

8. Schedule 1ZA requires NHS England to:

1. publish a procedure for entering into undertakings.
2. publish a non-confidential version of the undertaking where an undertaking has been accepted; and
3. issue a compliance certificate where it is satisfied that an undertaking has been complied with.

9. The terms of an undertaking (including, the action specified in it and the timeframes in which the action must be taken) may be varied if both the ICB giving the undertaking and NHS England agree.

Gathering and handling information

10. NHS England can investigate a potential failure to comply with patient choice requirements on its own initiative or in response to third-party information. In line with its oversight function, it may consider concerns raised by patients and providers about ICBs and seek to resolve these through dialogue with ICBs.

11. For complaints from providers about the patient choice provisions in relation to the qualification of providers, NHS England has established a Choice Provider Qualification Complaints Panel (the Choice Panel) to work with NHS England’s national patient choice team to provide advice and support the timely resolution of these types of complaint (where a provider considers a commissioner has not properly complied with a request to be assessed against qualification criteria, and the provider has been unable to resolve the issue directly with the commissioner , the provider can submit a complaint to NHS England using the pro-forma complaint form on NHS England’s website/email address england.choice@nhs.net). The Choice Panel may make recommendations in relation to the use of investigation or enforcement powers, which are subject to the governance arrangements outlined in paragraph 17.

12. By maintaining records of complaints raised about compliance with patient choice requirements, NHS England can identify any potential concerns and intervene where it will bring the most benefit to patients.

13. NHS England prefers to give parties an opportunity to provide information voluntarily to assist its enquiries. However, in certain circumstances, it may be more appropriate for NHS England to exercise its formal information gathering powers (section 14Z60 of the NHS Act 2006) – for instance, at the request of a party; or because it has concerns that not all relevant evidence has been or will be handed over; or because it has concerns about the accuracy of the information given to it.

14. NHS England manages confidential and sensitive information with great care, ensuring that it is only used for the appropriate purposes and that it is shared within NHS England or more widely only to the extent strictly necessary for the intended purpose. See section 3.3 of the NHS Enforcement Guidance for information on NHS England’s handling of sensitive information.

15. NHS England will evaluate and analyse the gathered information to determine whether initial concerns about an ICB’s role in performing its patient choice functions are sufficient to warrant further investigation. This may be done as part of NHS England’s ongoing considerations of an ICB’s overall performance or as a standalone exercise. See section 3.4 of the NHS Enforcement Guidance for more information on NHS England’s approach to information evaluation and analysis.

Investigations                              

16. In some cases, it may be appropriate for the information gathering and analysis to be conducted in the context of a formal investigation. NHS England may open an investigation to look at whether an ICB has failed or is likely to fail to comply with a patient choice requirement in response to a complaint or on its own initiative. When NHS England becomes aware of a potential breach it will consider how to proceed in accordance with this guidance. See section 3.5 of the NHS Enforcement guidance for more information on NHS England’s approach to investigations.

17. The national patient choice team, supported by the Choice Panel, advises on action to support compliance. The national choice team leads investigation processes. For cases where the use of investigation and enforcement powers are being considered, the relevant committee of NHS England will take the decision, in line with NHS England’s scheme of delegation.

Outcomes

18. NHS England’s enquiries or investigation may result in any of the outcomes outlined below:

1. No action/informal action – NHS England may not pursue a formal enforcement where the evidence does not indicate a requirement for immediate action or there are other good reasons for not taking formal action (for example, because the issues are not of sufficient priority or the ICB is already taking effective remedial action). NHS England may agree informal action with the ICB, including providing guidance and support, and maintain dialogue and oversight of the ICB in relation to the areas of concern. Should further relevant information come to light suggesting that NHS England should revisit its decision, NHS England may do so at any point and will notify the ICB.
2. Acceptance of undertakings to prevent, mitigate or remedy failures to comply with patient choice requirements – where NHS England is investigating a potential failure to comply with a choice requirement, it may accept undertakings from the ICB to prevent a failure, or to mitigate such a failure. If an investigation has established that a failure to comply with a choice requirement has occurred, NHS England can accept undertakings to remedy the failure. Undertakings set out actions formally agreed between the ICB and NHS England to tackle any concerns identified. Further details on the process relating to undertakings is set out in paragraphs 19 to 28 below.
3. Direct the ICB – NHS England may issue directions for the purpose of preventing failures to comply with patient choice requirements, mitigating the effect of such failures, or to remedy a failure to comply with a patient choice requirement following an investigation. Specific powers to direct an ICB in respect of a failure to comply with a patient choice provision are set out at paragraph 7 and described further in paragraphs 33-39 below.

Integrated care board undertakings

19. NHS England may accept undertakings in respect of patient choice requirements only where an investigation into an alleged failure to comply with those requirements is being or had been conducted. Where NHS England considers that an ICB has failed or is likely to fail a patient choice requirement, NHS England may accept undertakings from that ICB.

20. An ICB can approach NHS England about offering undertakings at any point after NHS England has begun an investigation into whether the ICB has failed or is likely to fail to comply with a patient choice requirement.

21. Any discussions regarding undertakings are expected to take place in good faith with the aim of finding a simple and effective solution to concerns relating to the ICB’s compliance with a patient choice requirement. Where NHS England believes that an ICB is not engaging in good faith with a view to agreeing undertakings or it has otherwise not been possible to agree an effective solution it may continue an investigation.

22. Where NHS England determines that the proposed undertakings represent an effective solution to the identified concerns and it is minded to accept them, NHS England may consult third parties with a material interest in the matter, for example a complainant. NHS England will consider the extent of any consultation having regard to the circumstances of the matter. Typically, NHS England will want to seek views on how undertakings will protect the interests of patients or otherwise be of benefit. NHS England will consider any responses to consultation prior to deciding whether to modify, accept or reject the proposed undertakings.

23. The relevant committee of NHS England will take the formal decision to accept undertakings. The undertakings may be agreed in principle, then confirmed with the committee. In other cases, the relevant committee may agree a proposal to seek undertakings, or an outline proposal for undertakings, while authorising that an officer of NHS England approves the final undertakings. Similarly, the ICB will need to confirm its agreement to the undertakings, and this is typically done by way of a board decision.

24. A non-confidential version will be published shortly after the undertakings have been accepted (paragraph 3 of Schedule 1ZA to the NHS Act 2006). In publishing undertakings NHS England must ensure that it does not disclose commercial or private information that would significantly harm legitimate business interests or the interests of any person. The ICB will be provided with a draft of the undertakings and should identify any confidential information it wishes to be redacted prior to publication and provide an explanation as to why disclosure would or might significantly harm the private or commercial interests of the person or organisation to whom or which it relates. NHS England will not accept blanket redactions.

25. Once undertakings are agreed and in place, NHS England will notify certain stakeholders of the action that has been taken. For ICBs this will depend on the relevant issues. Stakeholders may include the relevant integrated care partnership, other NHS bodies within the system, and relevant regulators, such the Parliamentary and Health Service Ombudsman.

26. By agreement with the ICB, NHS England may vary undertakings that have been accepted, including terms relating to action to be taken and the period within which such action must be taken. The revised undertakings will be published following the same procedure on confidentiality set out in paragraph 24 of this Annex.

Compliance certificates

27. Where NHS England is satisfied that an ICB or provider has complied with an enforcement undertaking, NHS England will issue a compliance certificate to that effect. Typically, NHS England will issue a compliance certificate of its own initiative when it is satisfied that there is sufficient evidence of compliance. However, the ICB may apply to NHS England at any time for a certificate and NHS England will give its decision within 14 days (a response within 14 days (starting on the day after the day on which the application is received) is required by paragraph 5(4) of Schedule 1ZA to the NHS Act 20).

28. Should NHS England refuse an application for a compliance certificate in relation to a patient choice undertaking, its refusal decision may be appealed on the grounds that it was based on a factual error; was wrong in law; or was unfair or unreasonable (paragraph 6 of Schedule 1ZA to the NHS Act 2006 (patient choice undertakings). See the ‘How to appeal a decision to refuse a compliance certificate’ section below.

29. After accepting an undertaking, if information comes to NHS England’s attention that indicates the ICB has supplied it with inaccurate, misleading, or incomplete information relating to matters relevant to the undertakings, NHS England may treat the ICB as having failed to comply with the undertakings. In that case, after giving notice, NHS England will revoke any compliance certificate it may have previously issued to the ICB.

30. Where an undertaking is agreed but is then breached by the ICB, NHS England may consider placing the ICB under directions.

How to appeal a decision by NHSE to refuse a compliance certificate

31. A decision by NHS England to refuse to issue a compliance certificate in relation to a patient choice undertaking may be appealed to the First-tier Tribunal (the right of appeal does not apply to a decision by NHS England to give a direction to an ICB). The grounds for an appeal are that the decision was based on an error of fact, wrong in law; or unfair or unreasonable.

32. Guidance is available on how to make an application to the tribunal. In the case of an appeal against a decision to refuse an application for a compliance certificate, the Tribunal may confirm the decision or direct that it is not to have effect.

Directions

33. Directions are measures put in place for the purpose of preventing failures to comply with patient choice requirements or mitigating the effect of such failures, or to remedy a failure to comply with a patient choice requirement following an investigation. Where an investigation has been conducted NHS can direct an ICB to remedy a failure to comply with patient choice requirements.

34. If NHS England has accepted undertakings in respect of a particular failure or breach, it will not then impose a direction in respect of that same breach, unless the ICB fails to comply with the undertakings.

35. Directions should only be issued to an ICB as a last resort or where other intervention, or support measures, have failed to adequately address the failures to comply with a choice provision that have been identified.

36. Where NHS England determines that directions are required NHS England may consult third parties with a material interest in the matter, in the same way as described for Undertakings at paragraph 20 of this Annex. As with Undertakings the relevant committee of NHS England will take the formal decision to make directions or agree a proposal to make directions.

37. A non-confidential version will be published shortly after the directions have been made following the same procedure on confidentiality set out in paragraph 24 of this Annex.

38. Once undertakings are agreed and in place, NHS England may notify stakeholders of the action that has been taken.

39. The decision to issue Directions in respect of failures to comply with a choice provision is not appealable.

Publication reference: PRN00966