The window of opportunity is still open (until 4 March, when the consultation closes) to influence how the CQC will regulate health and social care providers going forward.
For those who have yet to respond to the CQC’s consultation on its future strategy, this alert shines a light on aspects of the proposed changes likely to impact providers the most and offers our perspective on some of the issues/challenges/questions these raise.
The strategy proposals paint a picture of a nimbler, tougher, broader and more supportive regulator - but what lies ahead?
More nimble?
The strategy proposes a radical overhaul of the inspection regime as we know it, with a move away from scheduled inspections towards continuous analysis of data to inform ‘real-time’ ratings for providers. Whilst some providers may welcome living without the burden of periodic comprehensive CQC inspections, others may be concerned that, under the new regime, they will instead be subject to a more constant style of scrutiny by the CQC. The prospect of health and social care users being able to access a more up-to-date picture of the quality of care at a service has to be positive, and will also mean that providers who have had a poorer rating on a previous inspection should in theory be able to improve that rating more rapidly, rather than simply wait until the CQC decide to inspect again. What goes up, however, can of course - equally rapidly - come down, with ratings to be considered more frequently and on different evidence to that used historically.
The strategy proposals also raise many questions about the source, accuracy and integrity of the data which the CQC will use to inform ratings, and providers are also likely to want to know more detail about how the regulator intends to use ‘artificial intelligence’ to replace the manual review of data obtained during the inspection process. Providers will be equally keen to know how the concept of ‘real-time’ ratings will work in practice and, importantly, how they can be challenged. The current CQC inspection regime allows for correction and where appropriate, challenge, ahead of report publication via the factual accuracy process, but the CQC have so far not been drawn on how they envisage providers being able to challenge the accuracy of any findings which may negatively impact on a rating under the proposed, more dynamic, data-driven system. Also, whilst the current regime allows for challenge post-publication via a ratings review where there is evidence that the CQC has not followed their own processes in awarding a rating, in circumstances where ratings have been reached using ‘artificial intelligence’ or ‘innovative analysis’ as proposed, it is unclear how the CQC will ensure transparency in how ratings judgments are reached. The devil is, as ever, in the detail of how the new strategy will be implemented.
Tougher?
One of the key themes underlying the proposed strategy is a desire to accelerate improvement in areas where it is needed and some of the language used in the consultation gives a strong indication that the CQC will adopt a robust approach to making this happen. There is an emphasis on “calling out” unwarranted health inequalities and “unacceptable” behaviour from providers, and a commitment to responding quickly to concerns. This provides the CQC with a challenge in ensuring that decisions and actions taken rapidly are robust and supported by evidence which has been triangulated and verified to ensure accuracy, whilst still allowing providers a reasonable opportunity for challenge and response.
It is already our experience that the CQC are making increased use of the urgent enforcement powers available to them in existing legislation to impose urgent conditions on providers or require rapid turnaround action plans (sometimes within hours) so it is notable that within the consultation the regulator commits to intervening more quickly when they identify people who are at risk - does this mean a continued increase in the use of existing emergency enforcement powers (s.31) or is the CQC considering alternative approaches to effect change?
The consultation makes repeated, understandable, reference to culture and leadership as being key ingredients in creating and sustaining a safe service. It seems likely that the tougher, more immediate response to risk will include taking action in response to organisational and systemic concerns. Care will be needed to ensure that any response is measured, proportionate and targeted, recognising that in the vast majority of situations where cultural and organisational concerns are raised, the provider will need time to be able to demonstrate meaningful, sustainable change, rather than the quick fixes that can be achieved within the very tight response deadlines that are often used under the current enforcement approach.
Broader grip?
Another key element of the proposed strategy embraces the wider sector landscape changes announced in the White Paper launched on 11 February 2021, heralding system-wide changes at a policy and legislative level. The changes in Integrated Care Systems, reduction in local CCGs, legislated collaboration between health and Local Authorities, all speak to a place-based population health and social care agenda. For such a system to be effectively regulated requires a conscious shift by the CQC in approach, and the draft strategy indicates the time has now come for the CQC to plan for regulating at a local system level, by adding specific scrutiny to their registered providers on issues such as collaboration with local partners, continuous improvement with an eye to health outcomes, and health inequalities. The strategy indicates a strong focus on how services work with each other and in partnership with communities, suggesting “It will be unacceptable for services not to be working in this way”.
The ‘big society’ tone to the proposed strategy continues, as the CQC indicate that they plan to look at how every provider embeds equality, diversity, inclusion and corporate social responsibility in “everything they do” to benefit local health and wellbeing, society, the economy and the environment. Such wide-ranging aspirations are of course laudable, however translating this into matters that can be regulated appears ambitious, and may create inequalities in provider types unless proportionate responses are uppermost in the CQC’s mind when considering these matters.
Are these now to extend the fundamental standards and new KLOEs created to analyse providers’ approaches, or does this aspiration and scrutiny sit more at the level of a new ‘voice’ the CQC plans to have in the sector to effect real change and improvement? It is a very notable, and probably welcome, shift in positioning for the CQC as a regulator, to get more actively involved in wider health system issues, as part of the drive for improvement in quality, safety and equality of access to services. However the practical impact of this extended ‘reach’ requires further exploration, to ensure transparency of function for the CQC with their regulatory hat on, as opposed to broader contribution to the wider health system improvement agenda.
Finally, the strategy revisits a proposal to widen the definition of ‘provider’, which appears to be resurrecting the idea first raised some years ago about extending the CQC’s reach to Top Cos/parent companies to ensure accountability for the true decision makers controlling and directing activities in corporate group structures, delivering enforceability against a wider range of registered provider entities.
More supportive?
Alongside the more rapid intervention approach described above, the proposed strategy also suggests the regulator intends to adopt a new approach as an encourager, with an emphasis on supporting services in health and care systems to improve. Whilst this was always the underlying intent for the CQC, our clients have struggled to see this element of the CQC’s role come to the fore historically but will no doubt be interested to see how this translates to positive engagement with the regulator in this new era.
The CQC envisage providing support to “facilitate national sector-wide improvement coalitions”, but it is unclear how this in practice will be delivered. Historically, the CQC have identified issues to local healthcare providers but then have left the identification of solutions to providers themselves. Some of the challenges that providers face locally cannot always be overcome with local solutions but require national solutions to address the problem - e.g. national staff shortages in specialist services. The CQC envisage encouragement of national partners to offer support to local systems, however it is unclear whether the CQC envisages a broader role in dialogue with commissioners regarding achieving local and national solutions.
In providing support and empowering providers to help themselves and to ensure consistency of service, the CQC envisage offering analysis and benchmarking data to providers to support self-assessment. This is potentially a very positive shift in emphasis and engagement as between the regulator and the regulated, provided comparator data is accurate and relevant, and presents credible benchmarking that providers have confidence in.
There is particular emphasis on encouraging innovative practice and technological change. Will the CQC expand their current work and become the national conduit for providers to share best practice/change given the proposed strategy makes reference to promoting collaboration?
Whilst the change of emphasis within the proposed strategy is encouraging, the CQC recognise that there is still a tension between these aims and its pure regulatory role. It is unclear as to how the CQC will manage this tension and whether, in practice, they can be both.
How can we help?
Our experienced team of healthcare regulatory lawyers work with organisations across the independent and public sector to provide advice and support on the full range of issues that CQC regulation brings with it, including:
• Strategic advice to Boards on the changing regulatory landscape
• 'Well-led' assessment support, including advice/mock interviews for Board members and senior managers
• Advice pre-registration, including corporate structures for start-ups or growth/acquisitions
• Pre-inspection compliance support - e.g. Head Office pre-inspection reports on key risk areas
• Regulatory due diligence within health and social care transactions
• Support with factual accuracy check responses to draft inspection reports, including working with in-house teams on which issues to include and how best to evidence them
• Advice on process flaws which may open the way to judicial review challenge if the factual accuracy process does not resolve the provider’s concerns
• Representations about Warning Notices, Notices of Proposal and appeals to the First Tier Tribunal about Notices of Decision
• Advice and support during CQC investigations, including preparing/accompanying Registered Managers and/or nominated individuals at interviews under caution for regulatory breach and defence of criminal prosecutions if charges are brought