Despite the clear benefits to taking the context of ICS working into account, as well as the need for regulatory frameworks to reflect the changing legislative landscape, there are still areas of uncertainty as new models of assessing and regulating ICSs and trusts are developed. While trusts support the direction of travel, it will be important that issues around accountability and governance, the management of trusts spanning multiple ICSs, and how quality and performance should be defined at a system level, are resolved as new models are tested and refined. Trusts are also worried about an increase in bureaucracy and burden if additional scrutiny of ICS performance is simply layered onto the existing regulatory system without reducing burden elsewhere.
Accountability and governance
The potential impact of system-focused regulation on trusts’ existing accountabilities is a prominent concern for trust leaders. Although NHS England and NHS Improvement states that changes to the governance of ICSs "will not fundamentally change the core duties and functions of NHS trusts and foundation trusts to improve quality of care for patients and meet key financial requirements", trusts remain concerned that new regulatory frameworks will create confused and conflicting accountabilities.
For example, the SOF sets out how performance will be assessed across systems as well as at trust and (for 2021/22) CCG level. ICSs will play an increasing role, depending on their level of capability, in overseeing trusts’ performance. Local oversight arrangements will be agreed by ‘memoranda of understanding’ with local priorities forming part of conversations about performance. NHS England and NHS Improvement has set out the expected governance arrangements of ICBs, but it is not expected that all trusts will be represented on this board, and where board members are drawn from local trusts, they will not be expected to act as representatives of either their own organisation or the wider trust sector. Trusts are therefore concerned that, for example, they could be placed in mandated support because the wider system has not delivered outcomes which were agreed in a conversation they were not party to. This demonstrates the need for full consultation and engagement in setting ICS priorities, given the importance of ensuring there is no separation between decision-making and accountability for delivering against those decisions.
ICBs will be expected to distribute funding to local partners, as well as develop plans for how they will meet local population needs. Under the SOF they will then be asked to participate in, or lead, the oversight of trusts’ performance against these plans, with allocations they have made. This raises important questions about how conflicts of interest will be managed if a trust is struggling to meet targets with the funding it has been given. The role of the NHS England and NHS Improvement regional teams in helping to resolve disagreements will also need to be made clear.
Similarly, CQC plans to roll out a framework for assessing quality across an area, and is currently developing a model for this. We expect the amendments to be tabled to the Bill to include a proposal for CQC to have powers to regulate and rate ICSs. There appears to be strong political appetite for ‘trust-style’ ratings for systems. If effective, this may offer increased transparency for the public, providers and national bodies about ICS performance. However, it is not clear what audiences would find a system level rating helpful, and whether this would be beneficial as giving ratings would imply a level of accountability that does not exist in practice: while CQC may intervene when trusts are rated inadequate, the same powers do not extend to ICBs. While decisions made by an ICB may influence performance and quality in its component organisations, trust boards will remain legally accountable for care. Trusts will need clarity on what outcomes they should expect under a variety of scenarios, with transparent lines of accountability.
Some trust leaders question whether the system has been ‘overcorrected’ from one in which people do not work together to support joined up care for local populations, to one which is beginning to embed multiple conflicting structures of accountability, while simultaneously creating accountability gaps. Despite complex agreements between providers and the introduction of duties to cooperate, when a serious failing in care is identified it will be the trust that provided the frontline care that holds legal accountability for the care they provide.
Measuring performance and aggregating data
CQC and NHS England and NHS Improvement are setting out how they intend to build a picture of performance and quality across systems. This raises questions around how data collected at provider-level and aggregated to ICS-level can offer a meaningful understanding of the contribution the ICS leadership makes to the operational performance of its component organisations.
The aggregation of data means that if national regulators identify an issue at the level of the ICS, they will still likely need to drill down to organisational level to understand what is driving the issues. There is uncertainty about the utility of using traditionally organisation- level measurements aggregated to system-level as a proxy for a system-wide picture of care. This approach also risks introducing confusion about where intervention would be best placed to drive improvement.
The influences of good performance and quality differ at the system level compared to the organisation-level. The ICB can drive good care and outcomes across its patch through strong leadership, building relationships, enabling collaboration and innovation, and making effective use of resources. However, it is trusts that deliver the frontline services and have a much clearer link to the quality of frontline care.
Despite this, there are clear benefits to striving for a better understanding of the link between local decision-making and leadership and the delivery of care, in recognition of the fact that trusts do not operate in a vacuum. They face decisions and trade-offs in managing their many responsibilities and challenges, with many of these influenced by outside pressures. It will be important that the same data aggregated at different levels is not used to derive conflicting conclusions depending on which organisation is being assessed. National leaders should instead use this process as an opportunity to create a holistic picture of the interrelated factors influencing performance in a place.
Any measurement of performance should bear a clear relation to the actions the organisation being assessed has taken to influence that measure. For example, system-wide performance against urgent and emergency care targets is only a reliable measure for how well an ICB has performed its own duties if accompanied by a clear narrative understanding of how decisions taken by the ICB, including planning and distribution of funding, has influenced the functioning of urgent and emergency care pathways and services.
The challenge of assessing quality at system level
Currently, CQC has powers to regulate registered providers ‘which carry on regulated activities’. As an adjunct to its formal regulatory powers, over the past four years CQC has been carrying out thematic reviews of local systems and reporting on how well system partners are working together to achieve desired outcomes for a defined population group. This has taken place through its system reviews of care for people aged 65 and older in 2018 and 2019, and more recently its provider collaboration reviews, which assessed systems’ COVID-19 response with a focus on specific services (such as cancer services and pathways). So far, CQC has not attempted to create an authoritative definition of quality at system level, and these reviews have been intended as informative, supportive assessments for systems to use for local learning and improvement.
CQC now intends to review how well systems are working together to improve outcomes for their populations. Although it does not intend to register ICSs as providers in order to regulate them, there are still unanswered questions about how an assessment of quality at system level can meaningfully reflect the impact of decisions being made at that level. A planned amendment to the Health and Care Bill is likely to introduce more formal mechanisms for CQC to assess ICSs, which will provide welcome clarity on how CQC’s role in the regulation of ICSs will look in the future.
ICSs do not directly provide care, but they will, through the ICB, set priorities, agree funding flows, bring together partners, review data to identify population need, and plan for how they will meet these needs. The challenge for CQC will be to draw a clear link between these functions and any future measure of quality at a system level, and create clarity on how ICSs are influencing quality at place and in individual services. Given system level assessments are intended to provide public accountability and transparency, it will be important for regulators to consider how the public relate to their local ICS.
Arguably, if services are challenged due to the leadership and decisions made by an ICB, then accountability should sit with the ICB board. However national leaders have not yet clearly set out how an ICS-level measure of quality would offer better public accountability than assessments of quality at service- and place-level, given that people receive care from services and along pathways often operating at the level of place. A core part of CQC’s assessment of systems will be how well they are listening to local communities, which raises a question about whether an ICS is the right level to look at this measure: there may be better opportunities at place for dialogue between providers and the public and a basis for accountability which is meaningful to all parties.
The role of non-NHS parties
The separation of the ICB and the ICP in the legislative proposals further complicates the task of ensuring accountability when regulating for quality and performance is clear. The purpose of assessing ICSs will be to understand how quality and performance is influenced by all the partners across a system, rather than by individual organisations. By its nature, this includes social care partners and local government, as well as the independent and voluntary sectors, all of which provide services which contribute to the effectiveness of pathways. However, these wider partners will sit on the ICP, rather than the statutory ICB. Given the ICB, which governs the NHS part of the ICS, is the only part of the ICS which will have statutory duties and will be regulated by these frameworks, there is a question about how robustly the wider system partners can be held to account for their contribution to outcomes and care in their patch.
The SOF can only apply to NHS organisations as NHS England and NHS Improvement only has powers to regulate NHS organisations. However, partnerships with non-NHS bodies are a significant part of trusts’ role as system partners, and there is a risk of creating an artificial separation between NHS and non-NHS parts of the system as a secondary consequence of the framework. For example, the SOF will assess trusts and ICSs on collaboration and relationships, but it is unclear how it will capture the impact of behaviours in organisations outside its remit, such as local authorities, primary care or social care, and this may leave trusts exposed to judgements on their contribution to system-working based on incomplete information. NHS England and NHS Improvement will need to consider further how to achieve this fundamental aim of system-level regulation within the bounds of available mechanisms of oversight. This is a complex question which has yet to be clearly addressed.
There is also still a need for further clarity about how non-NHS bodies outside the reach of the current regime will be taken into account as part of system-level assessments. Primary care, social care and local authorities and their wider services all make essential contributions to pathways, patient flow, patient experience and health outcomes, but do not fall within the remit of the SOF.
However, CQC does recognise its role in bringing together insights about wider organisations given its remit to regulate social care, primary care and the independent sector. This underscores the need for CQC and NHS England and NHS Improvement to work together in creating a shared understanding of what good looks like in systems despite their differing remits, so that trusts falling under both regulators will not be subject to conflicting judgements. Done well, there is an opportunity for CQC’s system-wide regulatory insights to offer helpful context to the SOF.
The need for a clear statement of how the performance and input of non-NHS partners will be included as part of assessments of how well pathways are working for local populations is even more important when considering the level of 'place'. Trusts and other NHS bodies will work alongside social care, local government and independent and voluntary sector organisations as a matter of course at a smaller level of scale than NHS England and NHS Improvement or CQC are planning to review. Trust leaders have expressed concerns that if resource challenges outside of their control, such as social care market challenges or financial pressures faced by local voluntary sector organisations, hinder progress locally on agreed outcomes, this could impact regulatory judgements made about their own contribution to this work.
Burden and duplication
Both regulators have stated an intention to avoid duplication in approach and reduce burden on trusts. However, statutory responsibility for the quality of health and care services still lies with trusts. This will continue to be the case after ICSs are placed on a statutory footing, so there remains a risk of overlap and ongoing duplicated intervention at trust and system-level as national regulators will need to continue to carry out assurance on how trusts are meeting their duties.
Trusts are supportive of greater coordination and alignment between NHS England and NHS Improvement and CQC to reduce burden and duplication at an organisational level, such as reducing repeated or duplicated data requests and avoiding. As the regulators bring ICSs into their frameworks, and begin assessing how well they are meeting their new statutory duties and contributing to care and outcomes across an area, this will likely become more complex and challenging to avoid.
NHS England and NHS Improvement’s SOF describes its ambition to work through ICSs as much as possible and sets out an intention for ICSs to oversee the performance of trusts that sit within their geographical footprint. Trusts have highlighted the risk that this could lead to the creation of a new oversight tier whereby duplication occurs between NHS England and NHS Improvement regional teams and ICSs, particularly if their specific roles are not clear and distinct. This will be particularly applicable to less mature ICSs which will be required to ‘jointly conduct’ the oversight of trusts with NHS England and NHS Improvement regional teams. It will be important for NHS England and NHS Improvement to clearly define the circumstances in which trusts would work through ICSs and when they would work with regional teams, to ensure duplication is avoided as much as possible.
Regulation within and of systems could also become particularly challenging for trusts spanning multiple ICSs, which could be subject to multiple judgements and duplicative assessments, particularly as ICSs begin to take on oversight responsibilities. Some trusts straddling multiple ICS boundaries, such as ambulance trusts, some community service trusts and those providing specialised services, have highlighted to us the risk that they could be held accountable by more than one ICS. This could lead to increased paperwork and overlapping data requests and assessments. Establishing a lead ICS working on behalf of the relevant ICSs, or streamlining regulatory activity at ICS level, could help to streamline the approach and reduce burden for trusts. This will require joined up communication between the respective ICSs and between ICSs and the trust in question, and support from NHS England and NHS Improvement where necessary.
With increasing coverage of provider collaboratives, NHS England and NHS Improvement and ICSs will also need to take into consideration the variety and types of arrangements that exist at place level (for example formal alliances or more informal collaborations) and how this will impact on its oversight approach at this level. Practically, this is likely to result in multiple overlapping lines of oversight, as trusts will be operating multiple collaborative arrangements across their patch for different services and populations, all of which will need oversight agreements. This will be extremely complex, and it will be important to consider the practical implications in terms of the resource required to adhere to all monitoring arrangements.
We will continue to highlight the need for greater alignment between NHS England and NHS Improvement and CQC within this new system context, and the commitment from both organisations to continue to align approaches is welcome. This is particularly pertinent as trusts continue to face significant pressure to recover services from COVID-19 while these changes to regulation are taking place. We highlighted in response to the Bill that some trust leaders are increasingly concerned about a mismatch between the pace and scale of change, and the sector’s capacity to carry out this major transformation at the same time as they grapple with pandemic recovery.
The shift towards regulating systems will require new datasets, regulatory capabilities, processes and assessment frameworks to support, and these will be significant new developments for trusts to adapt to. The regulators will need to take this context into consideration when implementing their new frameworks to ensure it doesn’t add burden at a time trusts can least afford it, provide appropriate support to trusts and ICSs and allow time for their approaches to bed in.
Intervention and improvement
The increasing focus on assessing quality and performance at a system level raises a significant question about how intervention will operate at this level. Meaningful regulation at a system level needs to be focused on improvement at that level, rather than at the levels below it.
If the regulators are using an aggregated measure of quality or operational performance across a geographical area, improvement or deterioration in one provider may alter the overall picture. It will be important that improvements are attributed to intervention or change at the correct level. National regulators will need to build a sophisticated understanding of the drivers of changing performance, so that fluctuation at the provider- level does not disguise ongoing issues or overall improvement across systems, or vice versa.
Similarly, it is unclear how CQC would intervene in the event of finding poor system-wide quality. Realistically, if CQC identified problems across a system, it would take a combination of interventions at ICS level on leadership and relationships, and at provider level on specific quality issues in services. If it does not have intervention powers at ICS level, CQC will likely seek remedies at the trust level. This risks undermining the purpose of assessing systems and leaves trusts vulnerable to regulatory intervention as a result of issues identified elsewhere in the system.
NHS England and NHS Improvement has set out its desired system-wide approach to improvement through its new ‘recovery support programme’, a welcome replacement for the previous special measures regime. Under this new programme, struggling providers are expected to receive support from stronger organisations within their ICSs, in recognition of the impact of wider-system pressures. While the direction of travel towards a more supportive, and inclusive response to challenges, is welcome, questions do remain about the practical operation of the new regime: There is a question around what this means for higher-performing trusts, which may be asked to take on additional risk, and whether wider system partners outside of the remit of the SOF could be asked to act differently, receive support or indeed offer support. NHS England and NHS Improvement will be reliant on the strength of relationships between system partners to make the programme work, and while relationships in systems have improved in many places over the past year due to collaboration in the COVID-19 response, there is still a risk that the effectiveness of the programme will be curtailed by strained relationships or differences of culture and governance between NHS and non-NHS partners.