Key issues for healthcare organisations · leading healthcare firm, overseen by specialist...

Key issues for healthcare organisations

NHS Confederation conference 2017

Introduction

Welcome to our special edition of key ideas for organisations working in the health sector.

At Capsticks we are the leaders in health and social care legal issues, acting for over 300 healthcare organisations. We pride ourselves on being one step ahead.

We hope you find this edition useful and if you need any help with anything feel free to let us know.

Rachael HeenanSenior Partner

[email protected] 680 529

How we can help?We provide an outsourced inquest and claims handling service for healthcare clients. For a fixed annual fee we will deliver all of your inquest and claims handling functions from the moment a request for records or statements is received to the reporting of the claim to NHSR or the listing of an inquest hearing. The service is provided at a lower cost to the Trust than your current service and sits within a leading healthcare firm, overseen by specialist healthcare lawyers. We will act as your claims and legal department and will liaise with all internal and external stakeholders in the claims and inquest processes.

Reducing your costs and increasing efficiency – inquest and claims management

Catherine BennettPartner, Clinical Law

[email protected] 0208 780 4731

Ian CooperPartner, Clinical Law


BackgroundIn March this year, the Care Quality Commission (CQC) confirmed it would use its regulatory powers to pursue a criminal case against an NHS Trust after a patient sustained serious injuries falling from a roof. To date, such prosecutions have only been directed at care home providers.

Duties owed under statute and regulationsThe duties owed under health and safety legislation and under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 are very similar in effect. s.2(1) Health and Safety at Work Etc Act 1974 – (“HSWA”) requires employers to protect, so far as is reasonably practicable, the health and safety of their employees, with a matching duty under s.3(1) owed to persons not in their employment such as patients, visitors and contractors. Breach of either duty is a criminal offence, punishable with an unlimited fine, and with the potential for individual criminal liability.

Regulation 12 of the 2014 Regulations relates to preventing people from receiving unsafe care and treatment and preventing avoidable harm or risk of harm. Breach of the regulations is a criminal offence and the CQC can prosecute without having to issue a warning notice.

HSE or CQC? The 2015 Memorandum of Understanding (MoU) between the CQC, HSE and Local Authorities makes clear that the CQC is the lead inspection and enforcement body under the Health and Social Care Act 2008 for safety and quality of treatment and care matters involving patients and service users in receipt of a health or adult social care service from a provider registered with CQC. HSE and Local Authorities have those roles where providers are not registered with CQC, and for all health and safety matters involving workers, visitors and contractors, irrespective of registration.

The MoU gives a non-exhaustive list of incidents that fall to CQC and HSE/Local Authorities respectively (leaving aside potential involvement of the police/CPS).

An Inspector Calls – but which one? The roles of HSE and CQC following health and safety incidents

CQC to consider and decide the action to be taken • patient/service user falling from a window;

• severe scalding of a patient/service user in a bath/shower;

• patient/service user with a need for assistance with eating being given inappropriate food and being seriously harmed or dying from choking;

• patient/service user who did not receive treatment in line with their care plan who died or was severely harmed as a result; and

• ill-treatment or wilful neglect of a patient/service user.

Incidents falling to HSE/Local Authorities • where the commissioner of the service, rather than

the provider, seems to have been primarily at fault;

• where the provider is not required to be registered with CQC;

• manual handling injury to an employee from moving ill-maintained trolleys; and

• a contractor’s tower scaffold collapses into a care home car park.

How we can helpWe have supported NHS bodies and private providers of health and social care facing prosecution for almost all of the breaches listed in the MoU, as well as for corporate manslaughter (investigated by the Police and CPS).

We provide on site representation nationally for organisations under investigation and advise on handling strategies both in relation to the investigator and assisting your communications teams in responding to press interest. If your organisation is prosecuted, we have unrivalled experience in supporting you from interview under caution, representations against prosecution, advice on plea, through to a contested trial or concluding on a guilty plea with effective mitigation to minimise the financial and reputational impact of criminal proceedings.

David FirthPartner, Litigation


Siwan Griffiths Legal Director, Clinical Law




The Constitution is a key document for every CCG, but recent developments suggest that not all constitutions are fit for the future.

Complying with your public involvement dutyUnder the NHS Act 2006, each CCG must include in its constitution a description of the arrangements it has made to secure public involvement in its planning and decision-making, and a statement of the principles which it will follow in implementing those arrangements. In a recent judicial review application, one of the grounds relied on by the Claimant in support of an argument that a CCG had failed to comply with its public involvement duty when consulting on major service changes was that its Constitution did not contain these provisions. Are you confident that your CCG Constitution could withstand this level of scrutiny?

Next steps on the NHS Five Year Forward ViewThe Next Steps document published in March 2017 explained that all STPs need a basic governance and implementation ‘support chassis’ to enable effective working. As a result, all NHS organisations now form part of a Sustainability and Transformation Partnership. In order to ensure that these new structures are consistent with the internal governance arrangements of each CCG, your constitution should allow for appropriate collaborative decision making. Whilst many CCGs amended their constitutions to allow for joint working in the context of the delegation of primary care commissioning responsibilities, some have not created a general power in their Constitutions to enter into joint decision-making structures for other purposes. Many CCGs are now also sharing appointments for their Accountable Officer, CFO and other roles. You need to ensure that your CCG Constitution allows for this approach before adopting joint working arrangements.

Is your CCG Constitution fit for the future?

Future-proofing your ConstitutionAmending your CCG’s constitution can be quite an onerous task. It will require support from the Membership; agreement of the Governing Body and approval from NHS England. Having reviewed more than 30 CCG Constitutions in the last 12 months we have identified various ways in which you can reduce the future burden of making amendments. These include:

• Making the CCG Scheme of Reservation and Delegation an appendix that does not form part of the Constitution so that you do not need to amend the Constitution every time the CCG decides to delegate a function;

• Removing descriptions of each committee of the CCG from the body of the Constitution. This means that you will not need to amend the Constitution each time you form new or additional committees in future;

• Subjecting your Constitution to a “health check” to ensure it includes all the information required by statute; that provisions relating to quorum and voting reflect the composition of the CCG and/or Governing Body and that paragraph references are internally-consistent and accurate.

How we can helpWe offer all CCGs a free initial 20 minute consultation to discuss your current constitution, and any changes you are considering. Following that consultation we can carry out a “health check” review of your Constitution and recommend changes that will ensure it is fit for the future, or if you have specific requirements in respect of joint decision-making; shared appointments or other amendments, we can provide wording based on our extensive database of tried and tested clauses.

Peter EdwardsPartner, Clinical Law


The Care Quality Commission (CQC) uses five questions to assess and rate an organisation’s services:

• Are they safe?

• Are they effective?

• Are they caring?

• Are they responsive to people’s needs?

• Are they well-led?

How does this impact on estates?There are two main areas where this will impact your organisation’s estate:

1. Regulation 15

The main focus on CQC estates compliance is through Regulation 15 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This focuses primarily on the role played by your estate in satisfying the CQC key question of whether your services are safe.

Regulation 15 sets out the requirements for premises and equipment. Premises must be clean, secure, suitable, properly used, maintained and appropriately located. As part of this, the premises need to meet the requirements of all relevant legislation, much of which relates to health and safety. Responsibility for any shortfall in meeting the regulation lies with the provider of the relevant care and treatment.

It’s important to note that providers keep legal responsibility under these regulations, even when they delegate responsibility through arrangements or contracts with a third party. So it’s vital that you document any contractual relationship, including occupational leases or licences. This is to assess, crystallise and minimise risk to your organisation and to flow down (or up!) any relevant obligations within your occupational arrangements.

2. Applications to add a location to an approved regulated activity

In April 2015 the CQC updated the application form for existing CQC-registered service providers who need to add a location to an approved regulated activity. For example, where (due to acquisition) you have won a new services contract and have taken over a service or location run by an existing registered provider. This now has a much greater estates focus than before.

The form now requires details of planning consent and building regulations consent for each new location. If you don't own the new location, the form requires confirmation that you have your landlord’s written permission and (if relevant) the mortgagee’s written permission to use the premises for the regulated activity. Where you don’t have this written permission, applicants must explain why it's not needed, or has not been received yet.

The CQC and your estate making sure you’re compliant

If you are occupying premises as a tenant, you will therefore need to get your landlord’s written consent to carry on providing your service, as a CQC requirement.

In any event, the best evidence of consent is via fully documented estates arrangements such as a lease or licence. This should also help to satisfy the CQC’s key question about whether your services are well-led.

How we can helpOur team of healthcare estates lawyers can support you in:

• Advising on CQC Regulation 15 requirements and their impact on your estate, including health and safety queries

• Negotiating leases and licences to regularise your occupation

• Undertaking CQC-compliant estates due diligence where you are acquiring a new services contract or in advance of business acquisitions

Mark Paget SkelinPartner, Real Estate


Henry Matveieff Associate, Real Estate


Get ready for the data revolution

The General Data Protection Regulation (“GDPR”) comes into effect on 25 May 2018. Whilst much of the content of the Regulation covers territory already charted in the Data Protection Act 1998, the emphasis in GDPR is more heavily geared towards transparency and accountability in how personal data is processed. The GDPR builds will place a more significant compliance burden on health sector bodies. For instance, health organisations will be expected to:

• provide enhanced privacy information more regularly

• undertake privacy impact assessments more often

• maintain comprehensive records of processing activities

• appoint data protection officers

• tell affected individuals when certain data breaches occur

• have in place organisational and technical measures to ensure and demonstrate compliance with all aspects of the GDPR (rather than simply security measures, under the DPA).

We await further detail on the specific national rules that will apply (which will follow the election), but in the meantime we recommend that organisations map the data that they hold and use; and the reasons they hold it. This provides a foundation to then assess areas where compliance with the requirements of GDPR will be necessary. It is important to remember that the new rules don’t just apply to patient data, but also to information about staff and members of the public.

How we can helpCapsticks has excellent experience in all aspects of advisory, transactional and contentious data protection and information governance work. Clients tell us that in this area our “input, knowledge and participation [is] immensely valuable”. Our friendly, practical team can help your organisation make the best use of information whilst achieving compliance with the law, including:

• Review, audit and development of policies, procedures and agreements, checking compliance with the new requirements

• Responding to complex subject access requests, complaints and data losses

• Liaising with the Information Commissioner

• Providing training for staff.

Francis LyonsPartner, Clinical Law


Andrew LathamSenior Solicitor




New collaborative working and relationship based contracts in healthcareIn the advent of the Five Year Forward view with the development of New Care Models and increased focus on care pathways contracting for outcomes, we have seen an increase in the scale and value of contracts in healthcare. Importantly these contracts have challenged providers by requiring skillsets outside of the remit of one provider in the care pathway, needing providers to review and adjust their approach to collaborate and develop different commercial and risk based relationships with other providers to a degree that was not previously present.

The demands of collaborative working can cover a wide range of working practices, both contractual and non-contractual. Many of these, such as joint ventures and partnering, will already be familiar to parties in healthcare, but some such as alliance contracting or population based Multi-Specialty Community Provider arrangements, Accountable Care Organisations (ACO) or Accountable Care Systems (ACS) are more recent developments in the healthcare field so the approaches are not yet as widely adopted.

The push towards greater collaboration in healthcare comes partially from central initiatives (including the Five Year Forward View, RightCare and New Care Models), as well as from the adoption of new approaches by commissioners such as alliances and collaborative framework arrangements.

NHS Standard Contracts are traditionally quite adversarial, with very little, if any, alignment between the Commissioner and the Providers interests. However, collaborative working methods would represent a significant shift away from this approach and have the potential to benefit the wider health system.

Collaborative working in the NHS can take a number of forms. At the lower end of the spectrum shown above commissioners and provider parties may include contractual commitments to act in a collaborative manner or in good faith. These could be new Memorandum of Understanding or new principles of working and governance arrangements which are then annexed to current contractual arrangements.

At the far end of the collaborative spectrum are forms of contract for population based healthcare which represent the greatest break from the current approach. For example, the MCP Contract envisages a whole population budget arrangement for more integrated provision of healthcare services across a defined population group. Under these contracts you may see an integrated provider team appointed to deliver the services under a new form of payment mechanism which would see the providers covering cost overruns above the agreed budget.

In addition, alliance type arrangements have recently been adopted by a number of NHS bodies (across Lambeth, Nottingham, Leicester and Stockport

The Spectrum of Collaboration in health contracting – relationship building

Networking1

Cooperation2

Coordination 3

Coalition4

Collaboration5

Relationship Characteristics

Aware of the other

organisation

Parties provide information to

each other

Parties will share information and

resources

Members share ideas and

resources to mutual benefit

Members belong to one system

Loosely defined roles under the arrangements

More defined roles in the

relationship

Defined roles for the parties in the

relationship

Frequent and prioritized

communication

Frequent communication is characterised by mutual trust

between the members and ownership of

shared risk and reward in agreed

proportions

Little requirement for communication

Formal need for communication

Frequent communication required by the closer model of

working

All members have a vote in a

decision making structure

Consensus is reached on all

decisions1

All decisions are made

independently by the parties

All decisions are made

independently by the parties

Some shared decision making

between the parties

Five Levels of Collaboration and Their Characteristics

Approaches to collaborative working

1 Table adapted from Frey, B.B., Lohmeier, J.H., Lee, S.W., & Tollefson, N. (2006). Measuring collaboration among grant partners. American Journal of Evaluation, 27, 3, 383-392

for example) for the delivery of various healthcare services such as urgent care and mental health services. Under the form of alliance adopted by Lambeth (previously adopted widely by the Australian state authorities and sometimes referred to as a ‘pure’ alliance approach) the services are overseen by an integrated alliance team, which includes the CCG and Local Authority.

Practical issues arising These issues can change depending on the levels of experience and approach of the parties to the collaboration, as well as any external factors, such as the drive towards New Care Models (the Virtual form of MCP utilised an alliance approach by way of example). Other issues could include:

(1) Shared ownership and responsibility for services

Providers will need to get used to sharing risk and gain as well as a different approach to delivery of the services which may put pressure on their existing workforce and infrastructure.

(2) Collaboration with your supply chain and with third party organisations (such as VCS)

There are debates in some of the wider population based contracts around how far the collaboration should be extended and whether parties should be part of the core contract delivery (sharing risks and reward) or rather be subcontractors. For those parties

who fall outside the collaborative relationship the providers need to take a clear view on how they will be incentivised to help the collaboration achieve its objectives. Will it be possible to flow down a painshare/gainshare mechanism and would success in the services mean that there is a reduced level of activity provided to other parties. This could create perverse incentives where these parties are incentivised to act differently to the core collaborative partners if they are not entitled to any share of the potential saving/gain.

NHS Organisations and delivery of more collaborative and relationship based workingProviders of healthcare services should consider at the outset of a process whether they are equipped to deliver in the collaborative manner envisaged by the contract and their commissioners. There are a number of potential approaches to contracting to facilitate and encourage collaboration; however a model which enforces collaboration upon parties who do not have a good relationship or track record of collaborative working is unlikely to get the best from groups of provider.

Working under these collaborative contracts requires a different mindset to the traditional contracting approaches in order to maximise the potential benefits from closer working and greater integration across providers. In these circumstances providers must be

willing, to embrace new ways of working both at a contractual level and in provision on the ground (i.e. co-located and integrated teams). Making decisions on a ‘best for service or best for population basis” will cause some conflict for healthcare providers who are familiar with operating to protect the activity conducted by their organisation. The culture shift to a ‘no blame/no claim’ culture can also be problematic given that organisations have been set against each other for many years under a competitive procurement framework.

Conclusion: New Models require new thinking and new approachesGiven the drive towards New Care Models and optimal pathway solutions it is likely that there will be a requirement for more contracts to be delivered on a collaborative/relationship based basis.

A move away from adversarial contractual approaches towards better collaboration between providers at all levels, has the potential to bring benefits to patients from more integrated care / redesigned care pathways around patients/populations rather than organisations. This can also unlock economies of scale for providers and help towards sustainability.

The greater alignment between the interests of providers can help deliver services more effectively and also allow for rewards to be shared between providers or even all parties to greatly incentivise performance, while the risks are similarly shared between those delivering the services, rather than being pushed around the system in a form of financial musical chairs.

How we can helpWe are working with health economies throughout England on their structures for the future. If you would like an initial chat for some of our ideas, please contact Mike Clifford or Jamie Cuffe.

Jamie CuffePartner, Commercial


Mike CliffordPartner, Head of Commerical


The Capsticks health team We have over 200 specialist solicitors – below are some of our key contacts:

Catherine BennettPartner, Clinical Law


Lisa GearyPartner


Jacqui AtkinsonPartner, Employment


David FirthPartner, Litigation


Mike CliffordPartner, Head of Commerical


Siwan Griffiths Legal Director, Clinical Law


Abi Condry Partner, Litigation


Martin Hamilton Managing Partner Elect




Philip HatherallPartner, Clinical Law


Jamie CuffePartner, Commercial


Rachael HeenanSenior Partner


Peter EdwardsPartner, Clinical Law


Sam HopkinsPartner, Head of Real Estate


Tracey LucasPartner, Clinical Law


Andrew RowlandPartner, Employment


Matthew Hunter Partner, Real Estate


David RobertsPartner, Clinical Law


Francis LyonsPartner, Clinical Law


Kiran SekhonPartner, Clinical Law


Peter MarquandPartner, Head of Clinical Law


Claire ShawHead of HRA Advisory


Henry Matveieff Associate, Real Estate


Ron SimmsPartner, Employment


Mark Paget SkelinPartner, Real Estate


Victoria WatsonPartner, Employment


Dan PurcellPartner, Litigation


Capstickswww.capsticks.com

@capsticksllp

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