Introduction

Under the Health and Care Act 2022 (the 2022 Act), NHS England has statutory accountability for oversight of both integrated care boards (ICBs) and NHS providers. NHS Improvement (Monitor and the NHS Trust Development Authority) has been abolished and NHS England has assumed responsibility for the regulation of providers of NHS services, the exercise of provider enforcement powers, and producing and revising guidance on those powers.

The NHS enforcement guidance was introduced in 2013 alongside the provider licence. Much has changed since then, so we wrote to the sector in October 2022 setting out our proposals to update the NHS enforcement guidance and align it with current statutory and policy requirements, including new legislation.

These changes were designed to reflect:

• the abolition of NHS Improvement and the transfer of functions to NHS England
• NHS England’s changed responsibilities under the 2022 Act, including:
  • new ICB enforcement powers
  • the removal of competition functions
• current policy and operational best practice.

These proposed changes were subject to a statutory consultation from 27 October to 9 December 2022.

This document summarises the feedback we received and any changes we have made to the final guidance in response. It should be read alongside the final updated NHS enforcement guidance, which will come into effect on 1 July 2023.

We are grateful to everyone who engaged with this consultation, helping us to develop this guidance.

Consultation feedback

We received 26 responses via an online consultation webpage and by email, and held 2 roundtables with providers and ICBs organised by national partners. NHS Confederation separately indicated that it agreed with the approach being taken.

Introduction of a two-tier approach to ICB enforcement

• To introduce an ICB undertakings process that would be applied at a lower threshold than that required for directions (reasonable grounds to suspect that the ICB has failed or is at risk of failing to discharge its functions).

Feedback

• 84% of respondents supported the proposed changes.
• Alignment of ICB enforcement guidance with the existing provider regulatory regime was welcomed. However, some respondents raised concerns that the introduction of undertakings could increase the regulatory burden and that NHS England could seek to agree undertakings based on suspicion alone.

Response and outcome

• The NHS enforcement guidance makes clear that NHS England will only seek to agree undertakings with an ICB where there are reasonable grounds to suspect a failure or risk of failure to discharge its functions. 
• The proposed changes have been retained in the final enforcement guidance.

Alignment with current policy and operational best practice

Proposal

• To reduce the emphasis on investigations in the event of suspected provider licence breach.
• To remove the ‘prioritisation framework’ Monitor used to inform its decisions on whether to begin cases or continue ongoing cases.

Feedback

• 92% of respondents supported the proposed changes.
• The shift away from rigid application of the ‘prioritisation framework’ and from formal investigations in favour of a more flexible approach based on NHS England regional teams and ICBs working together was welcomed.

Response and outcome

• The proposed changes have been retained in the final enforcement guidance.

Cross-cutting feedback on implementation of the NHS enforcement guidance

We also received cross-cutting feedback on the implementation of the guidance. Some respondents:

• raised questions about the roles and responsibilities of ICBs and NHS England with respect to enforcement action relating to providers, provider collaboratives and place-based partnerships
• requested that any enforcement action by NHS England should align with enforcement action being taken by other regulators such as the Care Quality Commission (CQC)
• expressed concern around possible enforcement action with individual providers where the root cause of challenges is system wide. Similarly, some respondents expressed concern that an ICB might face enforcement action for provider-specific issues.

Response and outcome

The guidance makes clear that the statutory power to enforce a provider rests with NHS England, and any action will be taken in consultation with the relevant ICB. The NHS Oversight Framework sets out further detail on the circumstances in which we may consider formal regulatory intervention and how we work with partners such as the CQC to align regulatory approaches. The enforcement guidance should be read alongside the NHS Oversight Framework.

We have updated the ‘Background’ section of the NHS enforcement guidance to clarify that we will only consider enforcement action against an organisation for issues that are directly within its control. All enforcement action will be evidence-based, proportionate and agreed by the relevant NHS England committee.

Other amendments to the guidance

The proposed changes relating to patient choice (and procurement) have still to be brought into force and there is currently no agreed date for doing so. The patient choice provisions have therefore been removed from the final guidance. In the meantime, the enforcement guidance on the procurement, patient choice and competition regulations remains applicable, with the adjustments from 1 July 2022 set out in the explanatory note on our website.

We have added references to NHS England’s specific enforcement powers on compliance with the NHS Payment Scheme. These reflect our direction-making powers relating to breaches of the NHS Payment Scheme rules, which are different from the general direction-making powers for ICB failure.

Publication reference: PR00308_ii