NHS England's new enforcement guidance

Following a public consultation in autumn 2022, NHS England (NHSE) has issued updated NHS enforcement guidance. It describes the approach NHSE will take to using its enforcement powers, aligning with the Health and Care Act 2022 (the 2022 Act), including how these apply to Integrated Care Boards (ICBs) and all providers of NHS healthcare services in England.

Since the NHS enforcement guidance was first introduced in 2013 alongside the provider licence, much has changed since then requiring an update to the enforcement guidance and to align it with current statutory requirements and new legislation.

These changes reflect:

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

Two-tier intervention regime for ICB enforcement 

NHSE’s new two-tier intervention process for ICBs is designed to ensure ‘parity’ with the provider enforcement regime by introducing undertakings as the first step of NHSE’s enforcement action for ICBs.

NHSE “may accept undertakings” from the ICB where it has “reasonable grounds to suspect a potential failure or is concerned that an ICB is at risk of failing to discharge its functions” according to the guidance document.

If an ICB does breach an undertaking this, then “may justify the use of directions. As with provider undertakings, an undertaking may be accepted on the basis of reasonable suspicion, rather than the higher threshold that applies for directions (where NHS England must be satisfied there is a failure or significant risk of failure).”

84% of respondents supported this change and welcomed the alignment of ICB enforcement guidance with the existing provider regulatory regime. However, some respondents raised “concerns” that “the introduction of a undertakings could increase the regulatory burden and NHS England could seek to agree undertakings based on suspicion alone”. NHSE in its feedback summary provide that it 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.”

Implementation of NHS enforcement guidance

The consultation feedback also raised questions on the implementation of the guidance. Respondents raised concerns about the roles and responsibilities of ICBs and NHSE with respect to enforcement action relating to providers, provider collaboratives and place-based partnerships.

NHSE state that the “statutory power to enforce a provider rests with NHSE, and any action will be taken in consultation with the relevant ICB” which is set out in the guidance:

“In keeping with a system-led approach, NHS England will discharge its duties in collaboration with ICBs, asking the ICB to oversee and seek to resolve local issues before escalation. Where NHS England intervenes directly with individual providers, this will happen with the awareness of the relevant ICB.”

But as to who decides the appropriate outcome for ICB and provider enforcement, NHSE guidance states:

• “For ICBs, NHS trusts and foundation trusts, and certain NHS controlled providers, NHS England’s regional teams take the lead in progressing enforcement matters. Teams are responsible for making recommendations on whether, and if so what, enforcement action is necessary based on the evidence.”

• “For certain NHS controlled providers and licensed independent providers of NHS services, the national independent provider team is responsible for ongoing monitoring and also takes the lead in licence enforcement matters, including opening and conducting any necessary investigations.”

Respondents also requested that any enforcement action by NHSE should align with enforcement action being taken by other regulators such as the CQC. NHSE refer to the NHS Oversight Framework which sets out detail on how they look to work with partners such as the CQC to align regulatory approaches.

NHSE say that “All enforcement action will be evidence-based, proportionate and agreed by the relevant NHS England committee.”

Patient choice provisions

The proposed changes to the patient choice (and procurement) have still to be brought into force. These provisions are therefore not covered in this guidance. In the meantime, NHSE state that enforcement guidance on the procurement, patient choice and competition regulations remains applicable, with the adjustments from 1 July 2022 set out in its explanatory note.