H E A LT H C A R E NEWSBRIE F The Jackson Reforms one year on The importance of being compliant Hospital chains: unlocking hidden value to improve patient outcomes Restricting the persistent litigant CCG governance lessons learned Monitor’s latest procurement guidance published Is saying sorry good enough? Is the stethoscope becoming obsolete? w ww. h em p so n s. c o . u k @ h em p s on s l e g a l J UNE 2 014 Healthcare Newsbrief Contents Welcome to the June 2014 edition of Hempsons’ Health Care News Brief. 2 Healthcare newsbrief April 2013 saw the inception of the biggest shake up to civil justice in recent memory. One year on, James Birch reviews their impact and asks whether the Jackson Reforms achieved their aims? 3The Jackson Reforms one year on? 4The importance of being compliant 6 Hospital chains: unlocking hidden value to improve patient outcomes 8 Restricting the persistent litigant 10CCG governance lessons learned 12Monitor’s latest procurement guidance published 14Is saying sorry good enough? 15 Is the stethoscope becoming obsolete? Victoria Yuan explains the importance for all NHS Trusts of being able to demonstrate compliance with the principles of competition law, given the serious consequences of a breach, which stretch beyond a Trust’s balance sheet. Corporate and commercial partner Christian Dingwall reviews the latest thinking behind hospital chains, and how they might be used in the future as a means of improving quality across the NHS. Sharon Cooney describes a case in which a Civil Restraint Order was obtained against a persistent Claimant. The High Court confirmed that the civil rights of a litigant in person could be restrained without infringing upon his Article 6 rights under the European Convention on Human Rights (‘ECHR’). Carol Mosedale looks back over the first 12 months of Clinical Commissioning Groups, and highlights some key governance lessons, especially in light of the potential for cocommissioning of primary care with NHS England. 2 Healthcare Newsbrief Now that Monitor has published its final substantive guidance on the provisions of the NHS (Procurement, Patient Choice and Competition) (No.2) Regulations 2013 (the “s.75 Regulations”), Oliver Crich and Victoria Yuan summarise the guidance. The Health Secretary, Jeremy Hunt, has said that doctors and nurses must ‘say sorry’ when mistakes are made in order to end the culture of defensiveness in parts of the NHS. The NHSLA has released a guidance document which further emphasises this message by reassuring clinicians that saying sorry is not an admission of liability but is the right thing to do. Sajeda Adam provides an overview. And finally, Lucy Cannon investigates whether the stethoscope, now almost 200 years old, is nearing obsolescence. The advent of point of care ultrasound devices would appear on the face of it to be the way forwards, but it seems the stethoscope still has a few years’ service left yet. The Jackson Reforms one year on? April 2013 saw the inception of the biggest shake up to civil justice in recent memory. More than one year on, have the Jackson Reforms achieved their aims? The anticipated reforms heralded by Lord Justice Jackson took effect from 1 April 2013. It had been expected that the majority of the reforms would focus on costs management. However the changes have been far wider reaching, creating a new civil litigation landscape in which the Courts have adopted a much stricter regime with an almost zero tolerance policy for non-compliance with rules and Orders. Structural changes Perhaps the most significant reform for the NHS and other public bodies is the ending of Claimant solicitors’ rights to recover CFA success fees and ATE insurance premiums from Defendants and QOCS (‘qualified one way costs shifting’). Since the 1999 Woolf reforms Claimant solicitors who secure compensation for their clients have been able to add ‘success fees’ to their costs claims (sometimes 100% of their normal costs) and recover these from the Defendant. Defendants have also been required effectively to refund the insurance policy premiums that have been incurred by Claimants pursuing a ‘no win no fee’ case. For claims issued after 1 April 2013 that recoverability no longer exists. However, this is balanced by an increase in some damages and the introduction of rules removing the right of successful Defendants to recover legal costs from unsuccessful Claimants. Whilst there was a rush of claims in the run-up to 1 April 2013 (Claimant lawyers wanted to make sure they could claim their success fees!), it is still too early to tell whether the new recoverability rules will result in significant savings for public bodies, although the expectation is that eventually they will. Practical changes Costs budgeting is intended to involve the Court early (rather than right at the end of the case) to prevent costs from spiralling out of control. At various stages the parties must tell the Court what costs have been incurred and what further costs they are likely to incur. The Court then approves a budget for the various stages of the litigation. It is too early to say whether this change will reduce costs, but the widely publicised case of Mitchell v News Group 3 Healthcare Newsbrief Newspapers demonstrates the new regime in action. The Claimant’s solicitors were late in filing their costs budget and sought to rely on ‘pressure of work’ and ‘staff shortage’ arguments to avoid sanction from the Court. The Court rejected those arguments and decided that the Claimant’s costs budget should be limited to Court fees only. As a result Mr Mitchell was precluded from recovering any other legal costs from his opponent (even if successful). His attempt to persuade the Court to grant ‘relief from sanction’ failed. Many similar decisions have followed Mitchell. There is a concern that this new stringent and inflexible emphasis on procedural compliance is compromising fairness and justice itself. Those arguments will run and run. Ultimately, the message from Jackson and Mitchell is clear. The right to pursue litigation and potentially recover damages and costs has changed. Parties are now compelled to strictly comply with the Court’s rules and Orders. Parties who fail to comply will suffer the consequences. The Jackson Five: What you need to know •Claimant’s costs should come down but it is still a little early to say how much and which of the changes is likely to be the real driver behind this in practice. •Don’t assume that the Court won’t be prepared to make what would previously have been regarded as an ‘unfair’ decision. We have seen an immediate change in attitude and this is the best way to ensure meaningful change. • Diarise deadlines immediately and ensure that an appropriate system of reminders is in place. Make any applications to extend deadlines before the deadline itself. Although by no means guaranteed to succeed, any application is far more likely to be successful if made in advance of the procedural deadline. Remind experts and witnesses of their duties in light of the Court’s new stricter approach. • Don’t rely on ‘pressure of work’ excuses for noncompliance with deadlines. We have seen from Mitchell that the Courts will simply take a zero tolerance approach in this situation. • Don’t dismiss Alternative Dispute Resolution. LJ Jackson concluded that greater encouragement should be given for this, particularly for low value claims. James Birch, Solicitor e: j.birch@hempsons.co.uk t: 0161 234 2484 www.hempsons.co.uk@hempsonslegal The importance of being compliant Additionally, the CMA has identified ‘NHS mergers’ as the hot topic for 2014. The Health and Social Care Act 2012 has made clear the application of competition law to the NHS. As a result of that Act, NHS organisations at every level and in their every interaction with patients, suppliers, competitors and regulators must now comply with competition law. This article focuses on compliance of competition rules by Foundation Trusts (FTs) and NHS Trusts. An effective compliance strategy enables an organisation to minimise the risk of competition law infringements, and the costs resulting from anti-competitive behaviour. What is compliance? In 2012, the European Commission published guidance on compliance with competition law. It identified the three main features of compliance: a) Organisations have freedom to decide how they wish to comply with competition law. There are no prescribed rules b) The benefits of an active and supportive compliance programme boost staff morale and enhance the organisation’s reputation c) Compliance with competition law reduces risk of breaches and fines. In essence, the Commission advocates a credible internal compliance programme that is supported by the organisation’s management and its leaders in order to establish an effective compliance culture. NHS regulators As the concurrent healthcare regulator with the CMA, Monitor has the power to enforce competition law against FT’s. It also has separate powers to enforce the competition conditions in FTs’ Provider Licence. NHS Trusts operating under the auspices of the NHS Trust Development Authority (TDA) must also abide by competition law principles. Although NHS Trusts are exempt from the requirements to hold a licence, in order to ensure fairness and coherence across the sector, the TDA requires them to comply with the choice and competition conditions in the Provider Licence. Strands of competition law The first step to compliance is for all Trusts to improve their understanding of competition law to help them to shape their long term strategy and ensure that competing Trusts are not breaching competition law to another Trust’s commercial disadvantage. “ “ On 1 April 2014, the Competition and Markets Authority (CMA) became the UK’s key regulator for competition law as the unified successor of the Office for Fair Trading and the Competition Commission. Its Chief Executive, Alex Chisholm, sent a clear message that the CMA is focussing on nurturing a culture of compliance as its new regulatory strategy. In order to understand compliance with competition law, it is necessary to distinguish between the rules governing merger control1 and behavioural competition law². Compliance with merger control regime The NHS is perhaps more familiar with the merger control regime as a result of high profile merger cases such as Bournemouth/Poole3 and Frimley Park/Wexham . Compliance with the merger control regime usually means that the parties to a proposed transaction need to undertake self assessment to determine whether it triggers the jurisdictional threshold for CMA clearance and to cooperate with the authorities in a helpful and timely fashion during the merger notification and investigation processes. 1These are derived from EU Merger Control Regulations and are enshrined in the UK through the Enterprise Act 2002 2These stem from the Treaty on the Functioning of the EU and implemented by the Competition Act 1998 (CA98) in the UK. 3The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust and Poole Hospital NHS Foundation Trust 4Heatherwood and Wexham Park Hospitals NHS Foundation Trust / Frimley Park Hospital NHS Foundation Trust 4 Healthcare Newsbrief The mostly likely scenarios where a Trust may fall foul of competition rules include sharing sensitive information during a collaboration with other Trusts and agreeing to share the market during tenders for commissioner contracts. “ “ It is imperative for NHS providers to understand and be demonstrably compliant with competition law in its day-to-day activities and interaction with competitors rather than just during major transactions. Often, breaches of competition law are discovered by the CMA either through whistleblowers, third party complaints or its own market intelligence. It is likely that Monitor is working closely with the CMA to gather information and is supporting the CMA in its investigations. The CMA has been given stronger investigative powers than its predecessors and has made clear that it intends to increase the use of these investigative powers to uncover harmful practices. The risk of non compliance for a Trust is potentially catastrophic: Monitor may levy financial penalties of up to 10% of a Trust’s annual turnover and directors engaging in the most serious forms of anti-competitive practices may face civil and criminal charges. The CMA has been vocal in its intention to increase the use of penalties such as competition (director) disqualification orders to deter anti-competitive behaviour. 5 Healthcare Newsbrief Practical steps Trusts can take to be competition law compliant A compliant approach needs to be embedded in an organisation from the top down. Management and leaders must set an example to the team that competition law simply has to be accepted as part of the overall risk management, legal obligations and licence condition compliance. This can be achieved by having a comprehensive and structured compliance training programme for the Board and decision markers. It is noted that the CMA has previously reduced penalties for organisations where they can demonstrate that active steps have been taken to comply with competition law, although it does not absolve an organisation from its breach. The next steps Compliance with competition law is business critical. Breaches of competition law attract serious consequences stretching beyond a Trust’s balance sheet. The CMA’s emphasis on cultivating a competition law compliant society is as relevant to NHS providers as they are to multinational conglomerations. Trusts must take note of this. “ “ Compliance with behavioural competition law Under the CA98, Trusts must not engage in anti-competitive behaviours. The two types of anti-competitive behaviours are: (a) Participating in anti-competitive agreements, decisions or concerted practices, such as market sharing or bid rigging (b) Engaging in a conduct which amounts to an abuse of a dominant position in a market, for example, limiting or restricting supply or innovation of healthcare to the prejudice of patients. Trusts are advised to take active steps to educate their members of competition law rules and implement an effective compliance programme both to demonstrate compliance to regulators and to avoid breaching competition law. Hempsons has developed a comprehensive competition compliance programme and toolkit to help the NHS to be competition law compliant. Contact Victoria Yuan (v.yuan@hempsons.co.uk) or Lindsay Draffan (l.draffan@hempsons.co.uk) for more information. Victoria Yuan, Solicitor e: v.yuan@hempsons.co.uk t: 020 7484 7640 www.hempsons.co.uk@hempsonslegal Hospital chains: unlocking hidden value to improve patient outcomes Specifically the review will consider: • The arrangements which could enable local and non-geographical networks of hospitals or services to be established under a single leadership team • A new framework for NHS providers who are certified as outstanding and the go-to people for turnaround projects and extended management responsibilities • Management contracts so that outstanding leadership teams can take on a more formal relationship with other providers • T he extension of the buddying and mentoring schemes in the special measures hospital programme • Improving incentives for the best NHS hospital trusts to take on turnaround projects and extended management responsibilities. “ “ The aim is not just to improve quality and safety, but to develop 7-day services and to centralise services where this will improve outcomes. The review is expected to produce a progress report in June 2014 and aims to submit its findings and recommendations to the Secretary of State by end September 2014. Hempsons has worked with clients to explore factors that may facilitate or inhibit NHS hospital chains, and the organisational models that may be appropriate for them. At first glance the 6 Healthcare Newsbrief foundation trust model may seem to run counter to the concept of hospital chains. Potential inhibitors are: • Localism – the membership model for most foundation trusts is largely based on local constituencies • Centralised management – foundation trusts are highly restricted in their inability to delegate decision-making beyond the board of directors • Autonomy – each foundation trust is an independent corporate body which is incapable of ownership or direction by a third party • Governance – a high performing foundation trust’s risk rating may be sensitive to the distressed balance sheet and performance metrics of a potential partner in a hospital chain • Competition – foundation trusts are treated as economic entities for the purpose of merger law regulated by the Competition and Markets Authority (CMA) under the Enterprise Act and there is a low threshold for a change of control that would trigger a merger inquiry by the CMA. The traditional NHS model of corporate growth has been by way of merger or acquisition between adjacent neighbours – typically a large foundation trust acquires a smaller neighbour. “ “ The Secretary of State has commissioned a review, led by Sir David Dalton, into how leading NHS organisations can establish hospital chains to expand their reach and deliver more for patients. But a foundation trust is likely to reach a maximum size beyond which one or more potential inhibitors will prevent it from further growth by accretion of neighbours. Hospital chains are likely to require innovative service and organisational models. And in seeking standardisation of the highest quality of care, there may be some loss of localism and autonomy. NHS England’s Chief Executive Simon Stevens has indicated that there is a future for smaller, local hospitals, but that may be at the cost of losing local independence. In the NHS context, the hidden value is likely to be the quality, compassion and volume of care: a successful NHS organisation will understand how to improve patient outcomes in another hospital or service line, which (for whatever reason) are beyond the reach of its current management. In a recent interview with the HSJ (reported 27 May 2014) Sir David indentified the requirement for a system – dubbed “credentialing” – to accredit a list of excellent providers who would be the go to candidates to take on ownership or management of challenged trusts. There will not be a one-size fits all solution for hospital chains, but potential organisational models for a successful NHS provider (Trust A) to realise hidden value in a challenged NHS provider (Trust B) by way of hospital chains will include: • B uddying arrangement – relatively informal sharing of operational best practice, but Trust A does not take on Trust B management functions • Interim management contract – similar to buddying arrangements, depending on the degree of formality. Trust A would provide management support (which may include a limited number of managers on secondment) but it would not itself provide a whole management team for Trust B • M anagement contract – a significantly different arrangement from interim management. Trust A would contract with Trust B to provide the Board level management team to run it • F ranchise agreement - A franchise contract would require Trust A to take full operational control of Trust Board to accept financial risks, up to an agreed level. Trust B would operate in association with Trust A’s brand, but there 7 Healthcare Newsbrief would not be a transfer of assets to Trust A and Trust B would continue as a separate corporate body • Acquisition - an outright acquisition by Trust A of Trust B. This model would definitely constitute a merger situation, but if Trust A and Trust B are not contiguous or close to each other, there would be a low risk of substantive competition issues regarding a reduction in patient choice and competition. And hospital chains are not just for a successful NHS provider to take on a challenged NHS provider. “ There is no reason why two successful providers should not partner or merge to establish a hospital chain. Looking to the future, by doing so they might be taking a big step towards setting up a regional or even national accountable care organisation (ACO) that will be well placed to bid for outcomes based commissioning contracts. “ In the context of commercial takeovers and buyouts, the purchaser’s aim is to extract profit by unlocking hidden value: the purchaser achieves a return on investment because he or she has seen value in a business that the current owner has not been able to find or realise. The top level management role of the hospital chain ACO would be quality and financial assurance, potentially liberating its provider units from the current national regulators, and so achieving a new form of localism and autonomy. Christian Dingwall, Partner e: c.dingwall@hempsons.co.uk t: 020 7484 7525 www.hempsons.co.uk@hempsonslegal Restricting the persistent litigant What right does Article 6 of ECHR confer? Article 6 is often more commonly known as the right to a fair trial. It provides that an individual is entitled to a “fair and public hearing” in the determination of their civil rights or obligations or criminal charges. In order for Article 6 to be engaged there must be a real and genuine dispute over rights and obligations that are recognised by domestic law. Case Summary The Claimant, Mr Nowak, was formerly employed as an anaesthetic nurse by the second defendant, Guy’s & St Thomas’ NHS Foundation Trust (‘the Trust’) and was registered with the first defendant, the Nursing and Midwifery Council (‘the NMC’). Mr Nowak was dismissed by the Trust in January 2012 and was subsequently the subject of disciplinary proceedings before the NMC. His claim arose from alleged breaches of the Data Protection Act and Protection from Harassment Act and claims that he had suffered bullying and harassment at work, which caused him to become ill and take sick leave. The NMC were investigating allegations that he had fraudulently claimed sick pay and participated in a training programme without the Trust’s permission. Mr Nowak issued proceedings in October 2012. He subsequently made no less than eight unsuccessful applications, all of which were made over a five month period and found to be wholly without merit. Following failure to comply with an “Unless Order” made on 5 March 2013, Mr Nowak’s Claim Form was struck out on 22 8 Healthcare Newsbrief March 2013. His application to set aside the Order of 5 March 2013 was unsuccessful. Even after the striking out of his claim, Mr Nowak made a number of subsequent applications to the Court, all of which were also dismissed without merit. “ Grounds for making a Restraint Order “ The High Court confirmed in July last year in the case of Przemyslaw Nowak v Nursing and Midwifery Council & Guys and St Thomas’ NHS Foundation Trust [2013] EWHC 1932 (QB) that the civil rights of a litigant in person could be restrained without infringing upon his Article 6 rights under the European Convention on Human Rights (‘ECHR’). Judicial findings that cases which have been struck out are ‘totally without merit’ can open the door to a restraint order. Having ruled that a number of applications brought by Mr Nowak were totally without merit, Mr Justice Leggatt indicated that he was minded to make a civil restraint order. He considered whether a civil restraint order was appropriate in this case in accordance with Rule 2.3(1) of the Civil Procedure Rules. The rules prescribe that one of three types of civil restraint order may be made once the criteria set out in the Practice Directions have been met; (i) a limited restraint order, (ii) an extended restraint order, or (iii) general civil restraint order. The rationale for making such order is that a litigant who makes claims or applications which have absolutely no merit harms the administration of justice by wasting the limited time and resources of the Courts. Coupled with this, the right of access to the Court is not absolute. Consequently Mr Justice Leggatt found that it is possible to impose restrictions on would-be litigants so long as such restrictions are not so wide ranging as to impair the rights protected by the ECHR and so long as the principle of proportionality is applied. Mr Justice Leggatt considered whether making an extended civil restraint order would impinge upon Mr Nowak’s Article 6 rights, as he argued. “ In making his order, Mr Justice Leggatt determined that a wider order was required from the default extended restraint order and so directed that Mr Nowak obtain permission from the Court before issuing any claim or making any application against either defendant in relation to any matter or against either party in relation to any matter arising from the instant case. The Court subsequently heard Mr Nowak’s appeal against a procedural decision of the NMC in which he was unsuccessful in his efforts. 9 Healthcare Newsbrief Key points This is a helpful case in reinforcing the contention that restrictions on access to the Courts by vexatious or persistent litigants are compatible with Article 6. Where a party to litigation issues a number of applications which are found to be totally without merit, particularly where the behaviour is persistent, a civil restraint order may be made restricting their access to the Courts, although each case will turn on their particular facts. “ Decision Mr Justice Leggatt decided that the Court had to satisfy itself of three questions before an extended civil restraint order could be made; 1.Satisfying the first ground set out in the Practice Direction, the Court found that the litigant had “persistently issued claims or made applications which are totally without merit”. Bhanmjee v Forsdick held that persistence in this context has an element of the “irrational refusal to take “no” for an answer”. 2.Next the Court considered whether such an order was necessary to protect the Court’s process from abuse. To do this, the Judge undertook a risk assessment of the case. 3.Having concluded there was a real risk of a further abuse of the Court’s process, the proportionality of making such an order was considered as the final ground and the least restrictive order necessary was applied. Ultimately this case shows that whilst the Court recognises that careful consideration must be given not to fetter a person’s right to a fair trial, such right is not absolute. Essentially the making of a civil restraint order requires careful consideration of risk, necessity and proportionality. This case demonstrates that the Court is willing to take such a measure if the appropriate criteria are met. Sharon Cooney, Senior Solicitor e: s.cooney@hempsons.co.uk t: 020 7484 7519 www.hempsons.co.uk@hempsonslegal CCG governance lessons learned CCG governance is complex and unique to CCGs. CCGs are structured differently from other organisations operating within - and outside - the NHS. CCGs are membership organisations but, unlike Foundation Trusts (FTs), their members are not confined to individuals. CCGs’ members are their local GP practices, which may be single-handed GPs, partnerships or companies. Whereas NHS Trusts, FTs, Special Health Authorities and NHS England (and previously Primary Care Trusts (PCTs) and Strategic Health Authorities) all have Boards with responsibility for exercising (or delegating) their functions, CCGs do not. CCGs have Governing Bodies comprising clinicians, lay members and others (as set out in their Constitutions), which may have responsibility for exercising (or delegating) some, all or none of their CCGs’ commissioning functions. Delegation In our experience, the majority of CCGs have delegated their commissioning functions to their Governing Bodies. Some lawyers are taking a restrictive approach to the ability of Governing Bodies to delegate those functions that have been delegated to them by CCGs. In our view, Governing Bodies have wide-ranging powers to delegate both their statutory functions and the functions that have been delegated to them, provided that CCG Constitutions are drafted appropriately. Some CCGs have delegated their commissioning functions to committees (of the CCGs) and not their Governing Bodies. CCG Committees have different powers of delegation from CCG Governing Bodies, and need to ensure that their delegations are both lawful and in keeping with their powers as set out in their CCGs’ Constitutions. 10 Healthcare Newsbrief “ “ It has been just over a year since the Health and Social Care Act 2012 gave responsibility to CCGs for commissioning health care services for their local populations and in this article we look at some of the key governance issues about which we have advised our CCG clients over the past year. Joint working CCGs do not currently have the power to establish joint committees (as PCTs did) with other CCGs. It has been recognised that this is a gap in the legislation. Working with clients over the past year, we have devised a governance structure that enables CCGs to establish committees (known as “committees-in-common”) that can make decisions on behalf of two or more CCGs. Where CCGs wish to work together to deliver service change across more than one CCG area, it is crucial that they can take joint decisions on matters such as how they will engage with members of the public and local stakeholders and, ultimately, which service change proposal is to be implemented. The committee-in-common structure enables CCGs to make such joint decisions – and has been implemented by a number of CCGs working together to achieve a large-scale service reconfiguration. It is a complex area of governance; all CCGs involved need to work together to implement the structure. The legislation is to be amended to give CCGs the power to form joint committees. It is important to note that this power will enable two or more CCGs to set up a joint committee, and not their Governing Bodies. Any joint committee that is established using this new power will therefore, only, be able to exercise functions of the CCGs i.e. functions that have not been delegated to the CCGs’ Governing Bodies or to committees or sub-committees of the CCGs. As, in our experience, the majority of CCGs have delegated most of their functions to their Governing Bodies, this new power will not facilitate joint working between CCGs in the way that many CCGs are expecting. CCGs may wish to consider re-visiting their governance structure (as set out in their Constitutions), in order to be able to take advantage of the new power, once it comes into force. Subject to the parliamentary approval process, the power for CCGs to establish joint committees will come into force from 1 October 2014. Conflicts of Interest When the government introduced its major reforms and proposed the creation of CCGs, it was with the intention of getting clinicians more directly involved in the commissioning process, in order to improve outcomes. As a result, many of the individuals sitting on CCG Governing Bodies and executive committees are local GPs (and other clinicians). In those roles, the GPs are responsible for commissioning services in the local community. The same GPs may, however, also be responsible for the provision of services in the community. This creates the potential for conflicts of interest to arise, which must be managed appropriately to protect the integrity of the commissioning system. CCGs need to ensure that they have robust processes in place to manage conflicts of interest so that they do not affect – and are not perceived to affect – decision-making processes. CCGs need to take steps to manage conflicts of interest: •In order to comply with the law •To ensure commissioning decisions can withstand scrutiny and challenge • So that the public and local stakeholders can have confidence in the commissioning system • T o protect their reputations and the reputations of those working for them “ “ The scope for actual and potential conflicts of interest to arise will significantly increase as CCGs take on responsibility for cocommissioning primary care with NHS England. 11 Healthcare Newsbrief CCGs need to ensure that: •They have processes in place to secure that their members, employees, Governing Body members and committee members declare actual and potential conflicts of interest and these are appropriately recorded •Their Governing Body or an appropriate committee can be quorate for the purposes of making decisions in relation to procurements • There is an appropriate level of clinical input into decision-making – with arrangements in place to enable individuals with relevant clinical expertise to be coopted onto the Governing Body or to become members of a committee where required (and permitted by their Constitution) • They create a record, in relation to each contract for health care services that they enter into, of how they managed any conflict of interest that arose (as required by legislation). Next steps We recommend that CCGs review their Constitutions to ensure that these give them the maximum flexibility to delegate their functions, within their statutory powers. Some CCGs are purporting to exercise their powers in ways that may not be permitted by their Constitutions, leaving their decisions vulnerable to challenge. CCGs should also review their processes for managing conflicts of interest (both in their Constitutions and their conflict of interest policies). Carol Mosedale, Solicitor e: c.mosedale@hempsons.co.uk t: 01423 724007 www.hempsons.co.uk@hempsonslegal Monitor’s latest procurement guidance published The guidance steers commissioners through the principles of fair procurement, avoiding anti-competitive behaviour and the protection of patient choice. In addition, Monitor has also published revised enforcement guidance outlining its investigation and enforcement processes for alleged breaches of the s.75 regulations. The s.75 Regulations create a framework for decision making that requires the commissioner to honour patient choice and to secure high quality, efficient NHS health care services that meet patients’ needs. The guidance is ‘principles based’ and provides examples of practical considerations that commissioners need to take into account. If commissioners can demonstrate that they have considered these and have applied the relevant elements of the guidance when making their decisions, this will be indicative of compliance with the s.75 Regulations. It is recognised that each commissioning decision needs to be made on a ‘case by case’ basis to meet the needs of patients and local populations by providing safe, efficient, joined up and value for money health care. “ There remains a debate on what is meant in the guidance and s.75 Regulations by the expression “single capable provider” and commissioners will have to make a decision on a case by case basis as to whether they are required or whether it is appropriate to put services out to tender. “ “ 12 Healthcare Newsbrief Commissioners have to apply the s.75 Regulations to their own activities. They also have ultimate responsibility for ensuring that any third parties (e.g. local authorities/ commissioning support units) engaged by them, to provide support or advice, also adhere to the principles of the s.75 Regulations. Commissioners may also consider whether it is appropriate to incorporate s.75 Regulations’ principles into any agreement for the provision of commissioning support services. “ Monitor has published its final substantive guidance on the provisions of the NHS (Procurement, Patient Choice and Competition) (No.2) Regulations 2013 (the “s.75 Regulations”). The s.75 Regulations apply to CCGs and NHS England. It is clear that where appropriate, Monitor intends for commissioners to comply with the s.75 Regulations without incurring additional costs or management time. For example, where the commissioner has prepared joint strategic needs assessments and joint health and wellbeing strategies, these can be used to show that it has considered the current and future needs of the population and to demonstrate compliance with Regulation 2 – the procurement objective. The guidance addresses commissioners’ objectives and each regulation in detail. The guidance reiterates that it is advisable for commissioners to maintain a robust paper trail to evidence how each element of each commissioning decision is arrived at. Monitor suggests that when making commissioning decisions, commissioners ask themselves the following questions (which are designed to ensure that such decisions are fair, transparent and in patients’ best interests). What are the needs of the health care service users? 2.How good are current services? How can the services be improved? 3.How can the commissioner ensure that the services are provided in a more joined-up way? 4.Could services be improved by giving patients a choice of provider to and/or by enabling providers to compete? 5.How can the commissioner identify the most capable provider or providers of the services? 6.Are the commissioner’s actions transparent? Do people know what decisions the commissioner is taking and the reasons why they are being taken? 7.How can the commissioner make sure that providers have a fair opportunity to express their interest in providing services? 8.Are there any conflicts between the interests of those commissioning the services and of those (potentially) providing them? 9.Are the commissioner’s actions proportionate? Do they reflect the value, complexity and clinical risk associated with the services in question and are they consistent with commissioning priorities? 10.Is the commissioner doing anything that removes or materially reduces the incentives on providers to provide high quality services or improvements to those services? Are such actions necessary and required in order to achieve benefits to patients? 11.Does the decision endanger patient choice under the NHS constitution? 13 Healthcare Newsbrief Monitor may only exercise its investigative powers in relation to complaints received from third parties although it may commence investigations independently in relation to suspected anti-competitive behaviour. “ 1. “ When investigating either third party complaints or alleged anti-competitive behaviour, Monitor may take formal or informal action. Formal actions include powers to require information, declare an arrangement invalid, direct commissioners to put in place certain measures to prevent breaches and accept undertakings from a commissioner. Monitor has stated that it will take enforcement action where doing so is proportionate both in terms of severity of the breach and cost to patient interests or restrictions on those interests. It is clear from the guidance that in enforcing the s.75 Regulations, Monitor will assess each matter on a case by case basis. Commissioners are therefore advised to take into account the considerations prescribed in the guidance but also to take a holistic approach. We have worked closely with Monitor since its inception and regularly advise commissioners and providers on the application of s.75 Regulations and other procurement matters. Should you require advice on the s.75 Regulations or any other procurement matter, please do not hesitate to contact us. Victoria Yuan, Solicitor e: v.yuan@hempsons.co.uk t: 020 7484 7640 Oliver Crich, Solicitor e: o.crich@hempsons.co.uk www.hempsons.co.uk@hempsonslegal Is saying sorry good enough? He aims to transform this culture by creating greater transparency in hospitals whilst supporting and encouraging staff to do the right thing. The NHSLA released guidance following the suggestions which emphasises this message by reassuring clinicians that saying sorry is not an admission of liability, but is the right thing to do. There are growing concerns about patient welfare and lack of transparency when mistakes are made. At the Mid Staffordshire Hospital a high profile enquiry found that 1,200 patients had died unnecessarily and many more were “failed by a system which ignored the warning signs and put corporate self-interest and cost control ahead of patients and their safety.” A further 11 more Trusts have since been placed in to special measures, after an official investigation highlighted concerns around high mortality rates. The NHSLA guidance recommends that a verbal apology should be communicated as soon as staff become aware of an incident, followed shortly by a written apology. Apologies should be provided by an appropriately nominated person. Who this will be will depend on the individual case. Important factors will be relationship to the patient, seniority and experience. 14 Healthcare Newsbrief “ Catherine Dixon, Chief Executive of the NHS Litigation Authority, said: “In cases where people perhaps bring a claim out of frustration, because they don’t feel that they’ve been given an explanation or that their complaints have been heard, an apology may make them less likely to pursue an action”. “We actively support organisations being open, transparent and candid with their patients. We have seen some cases where that hasn’t happened in the NHS. It’s important that we create and support the right culture and it can win back people’s trust.” “ UK Health Secretary Jeremy Hunt has said that doctors and nurses must ‘say sorry’ when mistakes are made in order to end the culture of defensiveness in parts of the NHS. The NHSLA guidance suggests that a local policy should explain the process of communication with patients. This would help equip staff with the necessary confidence to effectively communicate with patients. Hempsons has drafted a number of policies around patient care and communication procedures following incidents, contact us to find out more Sajeda Adam, Solicitor e: s.adam@hempsons.co.uk t: 0161 234 2427 Is the stethoscope becoming obsolete? Point of care ultrasound devices can scan for trauma, reduce complications, assist in emergency procedures and improve diagnostic accuracy. A number of air ambulances in the UK now carry and use portable ultrasound devices and the feedback is positive. A search of reported clinical negligence cases and literature reveals no cases of inappropriate diagnosis arising from the use of a stethoscope. In fact, the largest concern seems to be the risk of infection due to stethoscope use. Claims relating to the incorrect interpretation of imaging are however not infrequent and image interpretation is what is required when using point of care ultrasound devices. Images have to be interpreted accurately and anomalies can be missed even by a well trained and experienced eye. Furthermore, problems might arise with the performance and suitability of the device itself. Will the screen on a handheld device be big enough for diagnostic purposes? Clinicians adopting their use will need to be able to evidence the training they have received in using these devices and will have to be used where circumstances deem their use appropriate. They should not be used to replace a more thorough examination where such an examination is required. Detailed maintenance records will need to be kept as well so that it can be demonstrated that the device was fit for purpose when used. “ The journal of the World Heart Federation suggests that the stethoscope could be experiencing its final days due to the rapid advent of point of care ultrasound devices that are becoming smaller, increasingly accurate and less expensive. “ Whilst a stethoscope usually belongs to the individual doctor or healthcare professional handheld ultrasound devices remain costly. The stethoscope remains a powerful diagnostic tool in the correct hands. Over time and with appropriate training the same will be said for point of care ultrasound devices. In the interim the risks and benefits of adopting the new technology need to be carefully balanced. The stethoscope survives for the time being at least. Lucy Cannon, Solicitor e: l.cannon@hempsons.co.uk t: 01423 724037 Awareness of risks Point of care ultrasound devices are being used more frequently. “ “ Consideration needs to be given as to whether images taken can be stored and married up with the medical record for the patient with other scans and radiology. 15 Healthcare Newsbrief www.hempsons.co.uk@hempsonslegal Upcoming events Hempsons DoLS Seminar Hempsons Employment Seminar: There may be trouble ahead…! Trustee Training Workshops 25 June 2014 June/ July 2014 September/ October 2014 Hempsons Manchester All Hempsons offices All Hempsons offices Understand the implications of These seminars will help you navigate some of the Trustee training workshops aimed at charity the Supreme Court judgment in ‘Cheshire West’ and more troublesome issues faced by HR practitioners trustees seeking to understand governance and how Deprivation of Liberty was defined and what on a daily basis, topics include TUPE and their role; whilst demonstrating compliance with this means for healthcare professionals. grievances. the requirement under SORP to receive ongoing training. Hempsons gives you certainty in an ever changing legal landscape. Our sector knowledge means we can quickly get to grips with the key issues facing you and your organisation • Charity Law • Clinical Negligence • Commissioning healthcare •Commercial • Commercial Dispute Resolution • Competition law •Construction •Corporate •Crime •Employment • Environment and Sustainability • Foundation Trusts • Health and Safety • Information Law • IP, Media & Technology • Healthcare, Mental Health and Medical Law •Practitioners • Private Client •Procurement • Projects (LIFT/PFI/PPP) • Real Estate • Social Enterprises About Hempsons Hempsons is a leading national law firm specialising in health and social care, practitioners, real estate, charities and social enterprise sectors across the UK. Our highly experienced lawyers provide a number of cost-effective solutions for a range of private and public healthcare organisations, from employment law through to clinical negligence. We aim to achieve our clients’ objectives and provide support down to the last detail whether the issue is big or small, challenging or simple. We work with over 200 NHS organisations including NHS Trusts, Foundation Trusts and commissioning bodies, with services delivered by a team of over 130 specialist healthcare lawyers. A significant number of our employees hold dual qualifications, combining medical, dental or nursing qualifications with their legal credentials. You can find a list of our employees including their specialisms online. www.hempsons.co.uk LONDON | MANCHESTER | HARROGATE | NEWCASTLE Harrogate : 01423 522 331 | London: 020 7839 0278 | Manchester: 0161 228 0011 | Newcastle: 0191 230 0669 I Hempsons is registered with the Law Society of England & Wales and we are authorised and regulated by the Solicitors Regulation Authority No 51059.