Monitoring and enforcement

This page contains information on our regulatory oversight of independent providers and NHS-controlled providers, including our powers to take regulatory action. This page replaces the original information and guidance previously hosted by Monitor on GOV.UK.

Content

Overview

NHS England has a statutory duty to issue licences for providers of NHS services that are not exempt, and has enforcement powers to require providers to remedy licence breaches where there is evidence that this has occurred.

Oversight of independent providers

Independent providers are overseen under the risk assessment framework and reporting manual for independent sector providers of NHS services. This covers:

  • NHS England’s oversight responsibilities in respect of independent providers
  • how independent providers subject to the Continuity of Service (CoS) licence conditions are monitored, how risk to the continued provision of these services is assessed, and when action may be taken to safeguard continuity of NHS services for patients.
  • the annual reporting and self-certification requirements for all independent sector licensees
  • how NHS England keeps licensees’ business sensitive information confidential.

This was published on 24 July 2023 and incorporates updates that were consulted on between 25 January and 22 February 2023. It supersedes the previous risk assessment framework and reporting manual for independent sector providers of NHS services that was published in December 2020.

Providers subject to the Continuity of Service (CoS) conditions

Providers of commissioner requested services (CRS) as designated by commissioners. CRS are any services that commissioners have formally designated as needing the protection of the CoS conditions stated in Section 6 of the NHS provider licence. These are services that would need to remain in their area if a provider were to get into difficulty because:

  • there is no alternative provider close enough
  • and/or removing them would increase health inequalities
  • and/or removing them would make dependent services unviable.

Hard to replace providers as designated by NHS England. In some cases, a provider’s services may be of sufficient scale or complexity nationally or regionally that NHS England considers that their unavailability – due to the provider’s insolvency or quality issues – would impact on patients.

To identify potential ‘hard to replace’ providers, NHS England will consider one or more of the following factors:

  1. previous and existing CRS designations by commissioners
  2. known reliance on the independent sector for delivery of significant amounts of activity
  3. known fragilities in the sector such as staff shortages and adverse trends in CQC ratings
  4. regional reliance on a large independent sector provider that does not currently have services designated as CRS
  5. likely ‘market response’ to provider failure – that is, there may be no alternative organisations with access to external finance that could acquire or replace a failing competitor.

The application of our ‘hard to replace’ provider policy will allow us to apply the CoS licence conditions of an independent provider’s licence irrespective of existing CRS designations by commissioners.

A list of ‘hard to replace’ providers will be kept under review and it may change as providers enter or leave oversight in response to changes in markets and sector pressures.

Providers will be able to appeal their status as a ‘hard to replace’ provider once this status has been assigned by NHS England, on the basis that they do not meet any of the criteria set out above. The review process following appeal will be similar to (in terms of the timeframe and information gathering) a CRS designation review. However, ‘hard to replace’ providers will be subject to the CoS licence conditions from the time they are notified of this status and until an NHS England board sub-committee determines otherwise following a provider appeal.

Continuity of Service (CoS) licence conditions

The following table sets out the scenarios in which the seven CoS licensing conditions are applicable.

  CRS Hard to replace
CoS 1: Continuing provision of Commissioner Requested services Yes No
CoS 2: Restriction of the disposal of assets Yes* No
CoS 3: Standards of corporate governance, financial management and quality governance Yes Yes
CoS 4: Undertaking from the ultimate controller Yes Yes
CoS 5: Risk pool levy N/A N/A
CoS 6: Cooperation in the event of financial or quality stress Yes* Yes*
CoS 7: Availability of resources Yes Yes

* Only applies if the provider has received a notice of going concern risk or a notice of quality stress.

Some providers will be designated by NHS England as hard to replace and also have services designated by a commissioner as CRS.  In these cases conditions CoS1 and CoS2 will apply to the CRS.

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Oversight of NHS-controlled providers

NHS-controlled providers are providers that:

  • are not themselves NHS trusts or NHS foundation trusts
  • are ultimately controlled by one or more NHS trusts and/or foundation trusts, where ‘control’ is defined on the basis of IFRS 10
  • are not exempt from the requirement to hold a licence

NHS-controlled providers are overseen either under the ‘NHS oversight framework’ for NHS trusts and foundation trusts, or successor framework, or the ‘risk assessment framework and reporting manual for independent sector providers of NHS services’. This will depend on factors such as the scope of the services provided, size of turnover, and whether the provider is a wholly owned subsidiary or is jointly owned by a number of providers.

Further details can be found in the oversight of NHS controlled providers guidance.

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If you think you meet the criteria set out above or control an organisation in a way that meets the criteria, please email england.licensing@nhs.net as you will need to apply for the NHS provider licence.

Enforcement guidance

Providers should refer to this section for information on how action can be taken against healthcare providers who hold an NHS provider licence.

NHS England can take action against healthcare providers who hold an NHS provider licence if there has been a breach, or suspected breach, of licence conditions that has been confirmed via an investigation.

This guidance explains:

  • when we may investigate
  • how we may investigate
  • who we may investigate

It also outlines the penalties we can impose if we find a provider has breached their licence.

How to request the withdrawal of your NHS provider licence

If you no longer meet the licensing criteria (see ‘NHS England provider licence: Check if you need a licence’) then you should request the withdrawal of your licence.

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Contact us

For enquiries relating to the NHS provider licence, please contact england.licensing@nhs.net.