In early 2023, NHS England consulted on proposals for updating the risk assessment framework for independent sector providers of NHS services.

This follows amendments we made to the NHS Provider Licence Continuity of Services conditions to make specific quality governance requirements.

If we are satisfied that an independent sector provider has inadequate processes in place to safeguard quality, the new licence conditions give us the power, in extremis, to require the provider to take the necessary steps to address this.

This complements the existing Care Quality Commission (CQC) oversight/inspection regime by giving the NHS the flexibility to require the necessary actions to address failings highlighted by the CQC.

We received 19 responses to the consultation from licensed independent providers, licensed independent providers of commissioner requested services (CRS), other regulators and other stakeholders.

Responses demonstrated broad support for the proposed updates. The following themes came out of the responses:

1. Greater clarity on how the new approach will link with that of other regulators

Most agreed that working with CQC to collect relevant information is appropriate.

Some felt the proposed approach was too reliant on data produced by CQC, while others suggested that the framework was too duplicative of work already delivered by other regulators.

Concern was raised about a lack of consistency of approach by NHS England when quality concerns were raised by CQC.

The purpose of this updated oversight framework is not to duplicate CQC’s role as a regulator of care quality, but instead to ensure there are robust and consistent processes at NHS England to respond appropriately to concerns about independent sector providers.

The changes to the provider licence will provide us with regulatory levers to respond to the most serious quality concerns in situations where the NHS lacks any alternative provision.

We will consider a wide range of information when assessing providers. The information we need will, in most instances, already be available where the provider is deemed low risk.

In the first instance, a significant proportion of the information we use will be obtained from CQC, primarily; CQCs inspection findings and data that the organisation would have already provided to CQC.

There may be occasions when we need to request additional information, but we will seek to limit these.

2. Greater clarity on how the new approach will link with other frameworks/processes within NHS England

Some respondents asked for more clarity on how this updated framework aligns with other frameworks and processes within NHS England, including the NHS Oversight Framework and the National Quality Board (NQB) guidance.

Licensed independent providers are not subject to foundation trust (FT) conditions of the licence. Therefore, NHS England cannot regulate them using the same approaches set out in the NHS Oversight Framework.

Many independent providers also have material income streams from outside of the NHS and from non-public sector sources; therefore, elements will not apply.

We have aligned this framework to the NQB guidance on the escalation of quality concerns.

Maintaining the principle that concerns are initially addressed locally, with national intervention in extreme high-risk instances only, where local solutions have not been possible.

We have opted not to mirror the NQB categories of ‘routine’, ‘enhanced’ and ‘intensive’ in our risk ratings; as local categorisations may not accurately reflect the national view of that provider and we want to avoid confusion.

For example, a single location may be defined as ‘intensive’ under NQB guidance, but may represent an isolated quality issue when the provider is viewed regionally or nationally.

We have also considered the integrated care board (ICB) quality oversight responsibility and will continue to review our framework to ensure it remains aligned.

We have opted for three risk ratings (high, medium and low) because, in a risk-based approach, we do not consider there to be sufficient differentiation in how we would act between two lower-risk ratings.

This creates a difference between the three quality governance risk ratings and the four financial risk ratings. We will keep this under review.

3. Proportionality of oversight considering the risk posed

The majority of those who responded agreed with our proposals across each consultation question.

However, some raised concerns that oversight could be disproportionate where the risk was considered low and that it may not represent value for money.

Some also queried whether we should consider inherent risks or risks that providers may have little control over, for example, national workforce shortages.

We have proposed a risk-based approach as this means we can tailor our process to the risk present at each provider.

This means that where risk is considered low, our monitoring can be light touch to reduce unnecessary regulatory burden on the provider.

In scenarios of low risk, we will obtain information that will, in most instances, already be readily available, often from third parties (eg CQC). This will further reduce the burden on providers and streamline our process.

When assessing providers, a wide range of information will be evaluated, including inherent risks in specific sectors.

The context in which a provider operates will be considered; however, even where factors outside of the provider’s control lead to increased risk, there may still be value in increased monitoring to ensure continuity of essential services for NHS patients.

Other comments

Some respondents raised the concern that an adverse risk rating may significantly impact the provider if it were to be published.

We do not intend to publish risk ratings. This is consistent with the approach taken for financial monitoring.

We are, however, required to publish an up-to-date list of any enforcement actions currently in place. CQC ratings provide a transparent view of the quality-of-care organisations provide.

Respondents also queried why specific exit criteria for mandated support was not outlined.

While we do not think it is appropriate to set and publish strict exit criteria that may not fit all circumstances, we intended to develop exit criteria that are specific to each situation at the start of any support process.

We do not intend to publish exit criteria, and this is consistent with our approach to the national Recovery Support Programme.

With regards to the Hard to Replace provider policy, some respondents queried the value of interventions if quality issues were caused by external factors, for example, workforce issues.

Although there are potentially going to be scenarios where NHS intervention is less likely to lead to improvements, there will still be value in ensuring NHS England is aware of ongoing risks in the sector.

Some respondents also queried the loss of local insight when taking a national or multi-regional view.

The CRS policy, which is focused on locally commissioned services, will remain.

The Hard to Replace provider policy is designed to work alongside the CRS policy to make sure that NHS England is sighted on risks that could impact on patients.

We are therefore proposing that the factors outlined in the consultation will be considered when identifying Hard to Replace providers. We will continue to keep the provider list and the factors we consider under review.

Following consultation and a detailed review and consideration of all the responses we received, we have not made any material changes to the risk assessment framework.

We will keep our oversight approach under review to ensure it remains appropriate and fit for purpose.

If you have any questions, please email england.ip-monitoring@nhs.net.

Publication reference: PRN00425_ii