NHS commercial: commissioning
Improving joint commissioning: amendments to the NHS Act 2006
The DH has published a draft Legislative Reform Order (LRO) to address an issue that many of you will have faced since April 2013. Under the NHS Act 2006, commissioners currently face the following two obstacles in relation to joint working:
- Although section 14Z3 allows CCGs to exercise commissioning functions jointly, it does not allow CCGs to form joint committees. This seems odd, especially as PCTs could previously do this and as CCGs can form joint committees with other organisations.
- CCGs and NHS England can jointly exercise NHS England’s functions and NHS England can exercise CCG functions, where requested. However, CCGs and NHS England cannot jointly exercise CCG functions, or form a joint committee.
The LRO proposes both of these points be amended in the NHS Act 2006, to reduce the administrative burden on commissioners. Consultation on the proposals showed support for the changes. We have certainly been advising commissioners on how they can achieve joint working under the current rules and our view is that these amendments should be welcomed. They should make it easier for commissioners to work together in order to improve service quality, value for money and consistency.
A report by NHS Clinical Commissioners (NHS CC) calls for a more joined up approach to primary care commissioning. NHS CC found that the reforms to primary care commissioning were not supporting “transformational ambitions” at a local level and that clinical commissioners must be able to jointly commission services with NHS England if quality of care is to improve.
The publication, Primary Care Commissioning, Transforming healthcare in the community, explores the challenges to improving quality, offers some examples of good working partnerships and explains why integrated services must be founded on a “whole system” commissioning strategy if clinical commissioners are to improve care to patients and local communities.
Moving forward, NHS CC believe an immediate change NHS England could implement to improve collaboration between area teams and clinical commissioners would be to give teams “greater autonomy in deciding their local approach to primary care commissioning, rather than adopting a single operating framework”.
Commissioning support procurement framework launched
NHS England has recently announced the start of its procurement exercise to set up a framework agreement of providers of Commissioning Support Services. NHS England’s aim is to provide a framework to enable
commissioners to select from a list of providers that have demonstrated a capability to deliver a full end-to-end commissioning service. Providers will need to demonstrate capabilities across all service lines in each of the lots NHS England has developed via a consultation process with stakeholders. Bidders will be expected to bring in additional support as required and bids will be accepted from sole providers, lead providers (acting on behalf of sub-contractors) and multiple providers acting as a consortium.
The framework is split into two lots with the second lot allowing commissioners to select providers of more specific, niche support services such as medicines management and continuing healthcare and funded nursing care support services.
Commissioning support services are Part A services (as defined by procurement rules) so commissioners will need to ensure they procure such services via a process that complies with the Public Contracts Regulations 2006 and EU procurement principles. This framework agreement should simplify this for commissioners and help run a compliant process, provided of course that commissioners follow the call-off procedures in the framework.
Commissioners will be expected to competitively tender their commissioning support services in due course. The deadline for this was recently extended to April 2016.
NHS England has issued a pre-qualification questionnaire and details of how to access this are included in their announcement. Providers will need to respond by 12 May 2014 and an invitation to tender will then be submitted to shortlisted bidders on 14 July 2014. NHS England has signalled its intention to conclude the process and appoint providers to the framework by the end of November 2014.
Commissioners will not be compelled to use this framework agreement once it is established, and they will be free to run their own procurement exercise to obtain the commissioning support that best meets their requirements.
Regulatory: health regulation
Consultation outcome: regulation and governance of NHS charities
A DH review of the regulation and governance of NHS charities was carried out in 2011 followed by a consultation on proposals to change the policy on the regulation and governance of charities. The Government’s response was published on 14 March 2014.
NHS charities are linked directly to NHS bodies and as such are currently regulated by both the Charity Commission and the NHS Act 2006. NHS charities identified a number of key issues this dual regulation raises from appointing NHS body representatives to trustee bodies to avoiding conflicts of interest inherent in the corporate trustee model including the need for accounts to be consolidated in the NHS body.
The current legal framework may also give rise to tension for Government ministers who may be seen by some as being “inappropriately” involved in operational issues.
It comes as no surprise therefore, that respondents to the consultation welcomed the proposals to allow charities to seek greater independence under the sole regulation of the Charity Commission and to remove dual regulation requirements.
This change will allow charities to further develop the support they give to patients and improve their opportunities to generate future income. This will also mean NHS charities can, if they choose, appoint a dedicated board of trustees with the expertise to develop the charity. “A layer of central bureaucracy is also being removed because in future where NHS charities decide to follow this path neither the department nor ministers will be involved in appointments to the charities and fund transfers”, according to the DH’s response.
The first results of the new CQC ratings now in!
Ratings of NHS hospitals has been a controversial matter in the past. The Healthcare Commission had a system of ratings associated with their annual health check that they were required to publish. However, when the CQC was created, this requirement to publish ratings was abolished as they were considered to be an unnecessary burden for the regulator. Now ratings are back with recognition that the public need a way of understanding how their hospitals are doing.
Although it can be helpful to know how a regulator rates an organisation, it is also a challenge to explain what any rating actually means in relation to individual care. Of course a hospital’s reputation is key and it will be a challenge for the CQC to manage the process well and avoid possible judicial reviews in the future.
The system that the CQC has adopted is a four point scale comprising: outstanding, good, requires improvement and inadequate. There will be a rating of eight core services, including children's services, maternity and accident and emergency. These services will be inspected and rated against questions including whether they are: safe, effective, caring, responsive and well led. The results will then be used to provide the overall rating for the hospital. The CQC has said that where one or two services “require improvement”,' the overall rating generally will be “requires improvement”. Dartford and Gravesham Trust received a “requires improvement” overall rating despite six of the services achieving a good rating. This may be an approach that will cause potential dispute in the future!
The CQC has now published a report into its first wave of inspections. The public will now need to become familiar with how the ratings work and what information they can provide to help with choice of provider in the future.
For further information or advice please contact Katrina McCrory on 0121 456 8451.
Regulatory: duty of candour
Building a culture of candour: The Dalton and Williams review
Over a year after Francis, another review has been published in connection with his recommendations. As a result of this, the NHS has a further three recommendations to consider on top of the many already made. One of the shorter set of recommendations of recent NHS reviews so that must be positive.
One hope was that this report would assist the NHS, in a practical way, in capturing what needs to be done to create a culture of candour that everyone now accepts and agrees is needed and that the report concludes can act as a catalyst for change for the NHS generally.
The report acknowledges that patients need to be well informed and all caring staff have a responsibility to be open and honest. It sounds simple. Francis thought one way to achieve this would be to have a duty of candour for organisations and individuals. The Government has decided an organisational duty is the way to go. So how do Dalton and Williams thinks it will be achieved?
The three recommendations are made for all organisations registered by the CQC as follows:
A culture of candour requires all staff to be trained to disclose information about unanticipated events in a patient’s care and apologise when appropriate.
To improve the levels and accuracy of reporting patient safety incidents to improve organisational learning and not for criticism of individuals.
Close the audit loop by spreading and applying lessons learned into practice and publicly reporting these.
The duty of candour should apply to all cases of “significant harm”. This would include “moderate, severe and
death” harm that is notifiable to the CQC and “prolonged psychological harm” in line with the Being Open guidance.
The focus of any sanctions should have an impact on the provider's reputation. The NHS Litigation Authority (NHSLA) should consult on reimbursement of compensation costs.
The NHSLA, CQC and NHS England should set out how they will share intelligence about breaches of duty of candour and how they will incentivise candid behaviour. They should ensure proportionate action be taken by the commissioners and the CQC in the event of a breach, including a levy of financial sanctions on organisations who fail to be candid.
The report sets out the challenges for organisations and individuals to achieve the required culture and touches upon the practical ways this may be approached. Yet further work is recommended to be carried out by the professional and organisational regulators. However, it is clear from this report and from what Francis has already said, that change will only happen if each individual and organisation takes responsibility to embrace the duty of candour from now on.
For further information or advice please contact Katrina McCrory on 0121 456 8451.
Regulatory: information governance
Temporary lawful basis granted for use of personal confidential data (PCD) to validate invoices
The tenth edition of NHS England's Information Governance Bulletin is largely devoted to the steps that have been
taken to try and resolve the long-running issues relating to invoice validation for CCGs.
Invoice validation ensures that providers of health and social care services are properly reimbursed for the treatment and care they provide to patients. Prior to 1 April 2013, commissioning processes traditionally relied on the availability of PCD to perform invoice validation. However, since the enactment of the Health and Social Care
Act in April 2013, CCGs, General Practitioners and Commissioning Support Units have been unable to use PCD for invoice validation.
The Secretary of State for Health and Social Care has now approved NHS England’s application for support under the Health Service (Control of Patient Information) Regulations, also known as section 251 approval. This means that, until 22 November 2014, and subject to CCGs fulfilling certain conditions and providing certain assurances, it will be lawful for CCGs to access PCD for invoice validation purposes.
There are two sets of options available for invoice validation depending on whether or not the CCG has achieved stage 1 Accredited Safe Haven Status (ASH). The two sets of options are set out in the bulletin itself.
Health sector data protection report highlights areas for improvement
The findings of a recent Information Commissioner's Office (ICO) report suggests that health sector organisations could do more to improve procedures relating to the handling of personal data under the Data Protection Act. An audit of 19 secondary healthcare organisations, including NHS trusts, Health Boards, Health & Social Care trusts and companies with a focus on health services, looked at how personal data is managed by the organisation and how it complies with NHS information governance guidelines.
The ICO audit covered a number of key scope areas including data protection governance, records management, requests for personal data, training, awareness and data sharing.
For those with an appetite for detail, the report includes detailed audit observations. A summary of the ICO’s findings can be found below:
- All organisations had data protection policies and procedures in place but compliance with the policies was not always effectively monitored, for example through spot checks.
- All organisations had a system in place to track health records but only a few conducted audits for missing files.
- The physical security of records also varied, with concern raised particularly around unlocked trolleys used for moving files.
- A lack of simple password controls forcing regular password changes.
- Some organisations had little in the way of fire or flood protection in place for paper records.
- All organisations had appropriate information governance related risk registers and risk assessments that were regularly reviewed.
- The use of fax machines for sending personal information was a cause for concern given the human error associated with using a fax machine.
According to Claire Chadwick, ICO team manager in the good practice team, the findings of this report are an “opportunity for health organisations to review and improve practices and procedures based on the ICO's experience”.
Mills & Reeve can provide advice on information governance policy and procedure and also provide training to your teams.
Cyber attack leaves the British Pregnancy Advisory Service with a £200,000 fine
The British Pregnancy Advisory Service (BPAS) has received a hefty fine from the Information Commissioner’s Office (ICO) following an attack on its website.
The hacker, an individual who disagrees with abortion, gained access to the personal details of thousands of people who viewed the website. The intention of the attacker was to publish those personal details but, fortunately, the information was recovered by the police before publication.
BPAS was found not to have taken appropriate technical and organisational measures to prevent unauthorised processing of personal information on its website. Importantly, the ICO found the organisation failed to undertake necessary security testing on the website that would have alerted them to its vulnerabilities.
The ICO found it unacceptable that BPAS was unaware of the personal details stored on the website that were vulnerable to this type of attack. This was particularly pertinent given the sensitivity of the personal data stored.
Cyber attacks are on the rise. Organisations must be prepared and ensure information is held securely.
Covert recording of private discussions at disciplinary and grievance hearings
The Employment Appeal Tribunal (EAT) has, in the case of Punjab National Bank (International) Ltd and others v Gosain, considered whether covert recordings of both the public and private discussions disciplinary and grievance hearings should be admissible in evidence and concluded that the fact that the recordings had been made covertly did not in itself rule them inadmissible.
The claimant lodged claims alleging sexual harassment, sex discrimination and constructive dismissal. Prior to her resignation, she attended grievance and disciplinary hearings recording both the “public” conversations (remarks made in the hearings) and the “private” conversations (remarks allegedly exchanged during the adjournments). The employer objected to the recordings of the “private” conversations being used as evidence at the tribunal.
At a preliminary hearing, the judge referred to the case of Amwell View School Governors v Dogherty where the EAT held that secret recordings of the “private” deliberations of a panel conducting a disciplinary hearing could not
At first instance, the tribunal distinguished the Amwell case and held that the recordings were admissible as evidence. The comments that the claimant alleged had been made during the private deliberations were about issues not directly relevant to the matters being decided by the disciplinary and grievance panels. The tribunal said there was no reason why these particular comments, even though made in private, should be protected or treated as an exception to the general rule that relevant evidence is admissible. The employer appealed.
The EAT upheld the tribunal’s decision that the private comments made by the panel were not part of their deliberations on the matters under consideration and this could therefore be distinguished from Amwell. The EAT held that the fact the recordings had been made covertly did not, in itself, rule them inadmissible. That it would be for the tribunal hearing the case to assess the cogency of the recordings and their impact on the issues that it must determine, and therefore this does not mean that such recordings will always be inadmissible.
This case clearly serves as a warning for employers to be cautious to ensure that any discussions that they have at a hearing are appropriate as an express prohibition against the recordings of hearings without consent in a policy will not necessarily be enough to prevent them being admissible. It may also be wise to ensure that at the start of the hearing, the panel chair requests that all those present should ensure that mobile phones, or any other portable devices, are switched off, supplemented by a request that employees and their representatives should remove all their belongings from the hearing room during an adjournment.
For further information or advice please contact Jessica Johnson on 0121 456 8412.
Court rules that post-termination victimisation is unlawful
In Jessemey v Rowstock Ltd and Anor, the Court of Appeal has held that post-termination victimisation is unlawful under the Equality Act 2010 (EqA). The court considered that section108(7) EqA, that specifically excludes post- employment victimisation, was a drafting error.
The claimant was dismissed on the ground of retirement and claimed unfair dismissal and age discrimination. When the claimant later discovered that his former employer had provided an unfavourable reference, he brought a further complaint that he had suffered post-employment victimisation. An employment tribunal found that the claimant’s dismissal was both automatically unfair and age discrimination. However, his victimisation claim was rejected. In the tribunal’s view, it was not able to award any compensation because the EqA specifically excludes post-employment victimisation. The claimant appealed this decision.
The Employment Appeal Tribunal (EAT) upheld the tribunal’s decision and the claimant appealed again. Shortly afterwards, in Onu v Akwiwu, a different EAT took a different view, holding that the EqA could be interpreted as allowing a claim of post-employment victimisation.
Both cases were considered together by the Court of Appeal. The court held that although it was clear that the EqA did not include post-termination victimisation, it was equally clear that this was not what the draftsman intended. If post-termination victimisation was not included in the legislation, the UK would be in breach of its obligations under the EU Law. As a result, the court held that the failure of the statute to include post-termination victimisation was a drafting error.
In light of the tribunal’s finding that the bad reference was given because the claimant pursued tribunal proceedings, the court held that the claimant’s victimisation claim must succeed and that the case should be remitted to the tribunal for an assessment of compensation.
Employers must be mindful of this decision when giving references in circumstances where a complaint of discrimination has been raised as a negative reference could give rise to a claim for post-termination victimisation.
Patient matters: complaints
Reminder that complaints can no longer be put on hold if legal action is intimated
In a recent CCG bulletin, NHS England has reminded NHS bodies that the Local Authority Social Services and NHS Service Complaints (England) Regulations 2009 have removed the exclusion included in the 2004 complaints regulations that prevented a complaint being considered where the complainant has stated in writing that they intend to take legal proceedings.
By virtue of the 2009 regulations, since April 2009, where a complainant expresses an intention to take legal proceedings, NHS bodies should continue to try and resolve the complaint quickly unless there are compelling reasons not to do so.
Apparently Action against Medical Accident (AvMA) has brought to the attention of NHS England that some NHS bodies are continuing to put complaint investigations on hold where the complainant has stated their intent to take legal proceedings.
Only in exceptional circumstances can a complaint be put on hold, for example if there has been a formal request to do so from the police, a coroner or a judge. In circumstances where there is concern that the complaint should be but on hold, this should be raised by the relevant NHS body in discussion with the complainant about how the complaint will be handled. If an NHS body does decide to put a complaint on hold against the wishes of the complainant, they should be informed as soon as practical and provided with a full explanation of reasons for doing so.
The bulletin advises that NHS bodies should review and update their policies, literature and web information on complaints to make sure that it complies with the 2009 regulations and the contents of its advice.
The advice also provides that NHS bodies should make clear to complainants, who are concerned about the amount of time that it has taken to investigate their response, that they can complain to the Parliamentary and Health Service Ombudsman specifically about the issue of delay, who will investigate complaints in certain circumstances before the NHS body has responded.
The advice issued by NHS England was addressed to CCGs who in turn are expected to bring it to the attention of local providers.
For further information or advice please contact Jacqueline Haines on 0121 456 8453.
NHS England publishes a series of short films to promote the Child Protection - Information Sharing project (CP-IS)
Readers may be aware of CP-IS, which was developed last year, with the “first wave” roll-out happening in the
north of England and London. By 2015, it is intended that the majority of local authorities will be connected and able to make their information available to the NHS. By 2018, integration of 80 per cent of the 1200 plus unscheduled care settings is expected.
NHS England developed the project recognising that the process of identifying children who have been maltreated, or are at risk of significant harm from abuse or neglect, during a single attendance, remains difficult for even the most experienced clinician. If a child attends an unscheduled care setting and has a child protection plan or looked after child status, this will be displayed to the NHS user as soon as the child's basic demographic details (such as their name, address or NHS number) are inputted into the local IT system. The relevant local authority will be notified of the attendance.
CP-IS focuses on improving the protection of children who have previously been identified as vulnerable by social services when they visit NHS unscheduled care settings such as emergency departments, paediatric wards and maternity units. It will provide prompt and easy access to key social care information. Full details of the project and its roll-out can be found here.
NHS England and the Health and Social Care Information Centre have launched a series of short films to promote the benefits of CP-IS.
Patient matters: Mental Capacity Act and DoLS
House of Lords Select Committee report on post-legislative scrutiny of Mental Capacity Act 2005
On 13 March 2014, the House of Lords Select Committee published its post-legislative scrutiny of the Mental
Essentially the committee’s aim was to establish whether the Mental Capacity Act (the Act) is working as Parliament intended. It received written and oral evidence amounting to over 1,800 pages. (Laura Jolley, senior solicitor at Mills & Reeve, was part of a group of solicitors who joined with barristers from 39 Essex Street to make submissions).
In summary, the committee found that the Act, as a piece of legislation, has been generally well received but it has not been well implemented. The committee heard evidence that there have been problems with how capacity is determined and the concept of best interests, especially in medical settings, is not well understood. The empowering ethos of the Act has not been widely realised in practice.
The view that the Act is a good piece of legislation does not extend however, to the deprivation of liberty safeguards (DoLS). The report is highly critical of DoLS noting the view that they are “hugely complex, voluminous, overly bureaucratic, difficult to understand … (providing) minimum safeguards”. It concludes that the DoLS legislation is not fit for purpose. The courts have also been considering the application of DoLS as can be seen from the article below.
In total, the report makes 39 recommendations of which two are considered to be key. These are:
- To address the failure to embed the Act in everyday practice, responsibility for oversight of its implementation should be given to a single independent body.
- DoLS should be comprehensively reviewed with a view to replacing them with provisions that are compatible in style and ethos to the rest of the Act.
Landmark decision in deprivation of liberty case: what does this mean for your organisation?
The Supreme Court has recently handed down the long awaited judgment in the case of P v Cheshire West and
Chester Council (& Ors) and P (referred to in the judgment as MIG) and Q (referred to in the judgment as MEG) v Surrey County Council. The Lords agreed that P was deprived of his liberty and by a four to three majority decided that MIG and MEG were also deprived of their liberty.
New test and implications
This decision marks a fundamental shift in determining whether there is a deprivation of liberty within the meaning of the Mental Capacity Act 2005. There are likely to be thousands of people who were not considered to be deprived of their liberty before this judgment who will be now.
In summary, the test is met if someone is under constant supervision and control and is not free to leave.
Local authorities and health bodies alike will now have to reconsider their case load and determine whether they are commissioning a care package that amounts to a deprivation of liberty and if so, make the necessary referral for a deprivation of liberty assessment. If the service user is not in a care home or hospital, an application to the Court of Protection may be required. Failure to do so may result in a claim being made for unlawful detention.
DH letter 28 March 2014
On 28 March, the DH sent an open letter in relation to the judgment. It was addressed specifically to those who are:
- Involved in the assessment and/or authorisation of a deprivation of liberty
- Involved in the care of individuals who may lack capacity
- Responsible for policies and procedures relating to the care of individuals who may lack capacity Suggested actions include:
- When designing and implementing new care and treatment plans for individuals lacking capacity, be alert to any restrictions and restraint that may be of a degree or intensity that mean an individual is being, or is likely to be, deprived of their liberty (following the revised test set out by the Supreme Court).
- Take steps to review existing care and treatment plans for individuals lacking capacity to determine if there is a deprivation of liberty (following the revised test set out by the Supreme Court).
- Where a potential deprivation of liberty is identified, a full exploration of the alternative ways of providing the care and/or treatment should be undertaken, in order to identify any less restrictive ways of providing that care that will avoid a deprivation of liberty.
- Where the care/treatment plan for an individual lacking capacity will unavoidably result in a deprivation of liberty judged to be in that person's best interests, this MUST be authorised.
Mills & Reeve guidance
This remains a complex area of law. We have produced a briefing on the Supreme Court’s decision entitled Supreme Court hands down decision on the joint appeals of Cheshire West and P&Q that looks at the judgment in more detail.
We would be happy to assist you with any deprivation of liberty or Mental Capacity Act queries concerning your organisation or to provide training on these issues.
For further information or advice please contact Laura Jolley on 01223 222448.
Patient matters: Mental Health Act
MindEd launched to assist in identifying child mental health issues
The new MindEd website was launched on 25 March 2014. It aims to provide e-training to adults who work with children, from health and social care staff to community workers, faith groups and sports coaches.
It aims to provide simple, clear guidance on mental health. The website is still under construction but it aims to signpost information about services and therapies available to help children and young people with mental health issues. Topics covered include grief, self-harming and isolation.
The MindEd programme is funded by the DH and backed by the Royal College of Paediatrics and Child Health; The Royal College of GPs; The Royal College of Nursing; The Royal College of Psychiatrists; The British Psychological Society and Young Minds.
Joint review of the operation of section 135 and 136 Mental Health Act 1983 (MHA)
On 27 March 2014, the Secretary of State for Health announced a joint review of the operation of sections 135 and 136 MHA 1983 by the DH and the Home Office. These are the provisions that confer powers on the police to temporarily remove a person who appears to be suffering from a mental disorder and is in need of urgent care to a place of safety, so that a mental health assessment can take place and appropriate arrangements made.
There is a lot of public interest in the way these provisions operate in practice, in particular whether police officers are in the best position to make decisions about how to manage an individual experiencing a mental health crisis.
It is intended that the review of the legislation will ensure that it is fit for purpose, clear and workable. It will consider whether the current provisions respond to the needs of people experiencing mental health crises at the right time and improve outcomes for these people when they come into contact with the police.
For further information or advice, please contact Charlotte Mawdesley on 0121 456 8402.
Patient matters: fertility issues
Judge warns of perils of DIY surrogacy arrangements
In the recent case of JP v (1) LP (2) SP (3) CP (A child by his guardian), Mrs Justice Eleanor King warned of the dangers of informal surrogacy arrangements outside regulated fertility clinics, when an intended mother was left with no parental rights when a parental order was not applied for within time.
JP, unable to conceive naturally following an earlier hysterectomy, arranged for a close friend to be artificially inseminated at home with her (JP’s) husband’s sperm. Because the surrogate was unmarried and the intended father’s sperm was used, the child’s legal parents were the surrogate and the intended father, both of whom had automatic parental responsibility (PR) for the child. The intended mother had no legal status as mother and no PR.
Sadly the couple split a few months after the child’s birth and the intended mother left the marital home with the child. A shared residence order was made and the intended mother thereby acquired PR for her son. Failure to apply for a parental order within six months of the birth, left JP with no means of acquiring legal mother status. Adoption was not an option because JP and her husband had, by now, divorced and JP could not adopt alone because this would extinguish the father’s PR. A special guardianship order was, for analogous reasons, not appropriate. This left JP with PR for the child only by virtue of the residence order; if residence were lost, PR would be lost too. The court made the child a ward of court, to better manage the PR issues between the adults involved but there was no solution to the intractable problem that legal parenthood had not been transferred in time from the surrogate to JP.
The judge delivered the following warning:
‘This case … highlights the real dangers which can arise as a consequence of private ‘partial’ surrogacy arrangements where assistance is not sought at a regulated fertility clinic (or indeed full surrogacy arrangements where the child is born abroad). At a licensed clinic consideration will be given to the welfare of a child born as a result of the surrogacy arrangement and counselling services will be provided to the parties which will include the provision of information about the likely repercussions of a surrogacy arrangement and the importance of obtaining a parental order.
It is to be hoped that a multi agency surrogacy protocol will soon be in place in every Health Authority in England and Wales, drafted in conjunction with their local fertility units and local authorities. Such protocols would go some way to ensuring that, in informal surrogacy arrangements, the welfare condition is met and the adults will be given important information and advice.’
For further information or advice please contact Jane Williams on 0121 456 8421.
Patient matters: funding and provision of treatment and care
New regulations expand responsibilities of NHS England
These Regulations make amendments to Regulation 10 of, and Schedules 3 and 4 to, the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 (the principal Regulations) that require the Board to make arrangements for the provision, as part of the health service, of specified services or facilities, to specified people or groups of people.
Regulation 2 amends regulation 10 of, and Schedule 3 to, the principal Regulations in so far as those provisions require the National Health Service Commissioning Board (now known as NHS England) to make arrangements for the provision of services to persons in secure children’s homes. The effect of these amendments is to remove the exceptions to this obligation, meaning that the Board now has responsibility for commissioning community and secondary care services and services for rare and very rare conditions for those detained in all secure children’s homes.
Regulation 3 amends Schedule 4 to the principal Regulations (services for rare and very rare conditions) to give effect to revised commissioning responsibilities for the Board, that will now include atypical haemolytic uraemic syndrome services and hand transplantation for adults.
For further information or advice please contact Jane Williams on 0121 456 8421.
The latest CCG bulletin from NHS England
In its latest CCG bulletin, NHS England has sent a reminder to CCGs that they need to be ready to both deliver personal health budgets (PHBs) and provide people with information about them.
As readers will be aware, from April 2014, people receiving NHS funded continuing healthcare have the right to ask for a PHB including a direct payment (where money identified for the PHB is transferred to the person, who then purchases the services and support they want in line with the agreed care plan). From October 2014, they will have the right to have a PHB (subject only to clinical or financial grounds that are deemed to make a PHB unviable). The Regulations for direct payments came into force last summer.
Guidance on the Regulations and details of the support programme available can be found on the personal health budget website. Nearly 80,000 people already have a personal budget from their local authority and a few already have PHBs.
Within the bulletin, reference is made to the recent report entitled Personal Health Budgets: including people with learning disabilities from Think Local Act Personal (TLAP) in relation PHBs. The report was produced with the Local Government Association; NHS England and DH led Winterbourne View Improvement Programme. Readers who are/will be involved in setting up or overseeing PHBs will find various useful examples within the report.
The report concludes that PHBs could lead to better support and help avoid poor quality and inappropriate care. It provides various examples of NHS continuing healthcare teams and people from specialist learning disability
services working together to better integrate health and care support for individuals. Key success factors are identified as including having access to independent advice and support from other families, along with the option of a direct payment.
The report highlights that the bar should not be set higher for PHB holders. Support planning needs to be informed by clear clinical advice and that people should get the same opportunities and access to specialist support regardless of which organisation (children's services, adult services, NHS or local Government) is responsible for funding their care. It also emphasises the need for appropriate information sharing between different teams or organisations, particularly in relation to people who lack capacity to consent to sharing their personal information.
County court strikes out interest on redress claim; further guidance from the Ombudsman to come?
Last year Mills & Reeve were instructed by a CCG that had received a county court claim from an organisation that
represents individuals and their estates in seeking to recover from the NHS sums spent on residential care.
These organisations have sprung up since 2007 when the Parliamentary and Health Service Ombudsman (PHSO) published her report, Retrospective Continuing Care Funding and Redress, dealing with the arrangements for compensating individuals who were inappropriately left to fund, or contribute to the cost of, their care when the NHS had incorrectly found them not eligible for NHS continuing healthcare. The PHSO was critical of the guidance that had been issued to PCTs by the DH as to how redress should be calculated. The DH responded by issuing further guidance NHS Continuing Healthcare, Continuing Care Redress.
In this particular case, the dispute arose not from quantification of the principal sum to be reimbursed but from the interest rate applied. The CCG had paid interest at retail price index (RPI) throughout. The claim organisation did not dispute the use of RPI up to the date of death but argued that the CCG should have paid eight per cent from the date of death to the date of payment.
The CCG, contesting jurisdiction, argued that the correct forum for a dispute over the quantification of redress was the Administrative Court, not the county court; that this was a matter of public, not private, law and that the challenge should have been brought by way of judicial review. In the alternative, the CCG sought to strike out the claim as an abuse of process, and sought summary judgment because the claim had no real prospects of success.
The county court struck out the claim on the grounds that the principal sum had already been paid and therefore the sum could not be claimed again in those proceedings solely for the purpose of seeking a greater rate of interest. Moreover, the sum having already been paid, was not a judgment debt upon which the court had jurisdiction to award interest at eight per cent.
We understand that the claimant has submitted the matter to the PHSO for consideration of the interest rate issue. Further clarity from the current PHSO would be most welcome, given that Ann Abraham’s 2007 report and the subsequent department guidance were both compiled at a time before the Government’s Funding for Lending Scheme delivered a harsh blow to investors and the prospect of eight per cent interest became but a distant memory.
Government announces early access to medicines scheme
The early access to medicines scheme, which aims to address the need to improve access, on an unlicensed or off-label basis, to innovative medicines for patients with life threatening or seriously debilitating conditions without adequate treatment options, is now taking applications from pharmaceutical companies.
Under the scheme, the Medicines and Healthcare Products Regulatory Agency (MHRA) will give a scientific opinion on a new medicine or indication that has demonstrated a positive risk-benefit balance. The scientific opinion will be provided after a two-step evaluation process, the first being the “promising innovative medicines (PIM) designation” and the second the “early access to medicines scientific opinion”.
The PIM designation will give an indication that a product may be eligible for the early access to medicines scheme (based on early clinical data) and could be given several years before the product is licensed.
Companies who want to move to the second stage must hold a PIM designation and provide further relevant data on quality, safety and efficacy.
The scientific opinion will describe the benefits and risks of the medicine, based on the information submitted to the MHRA by an applicant after sufficient data have been gathered from patients who will benefit from the medicine. The opinion will support the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.
The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.
For further information or advice please contact Jane Williams on 0121 456 8421.
Proposed new legislation to encourage medical innovation
Case law on clinical negligence currently gives doctors a good basis for innovating where there is support for their decision from a responsible body of medical opinion. However, where a doctor is not confident that there would be such support if the matter came to court, the doctor may feel that there is pressure not to innovate.
If the Bill becomes law doctors will be able to innovate even where there is no body of opinion to support the innovation or where it is not clear whether a body of opinion exists.
There would still be certain safeguards in place, for example doctors should have sound reasons for their innovation and there would be a statutory best practice checklist that would act as a safeguard against irresponsible innovation.
The consultation is inviting the views of doctors, patients and legal professionals on whether the Bill would help to encourage responsible medical innovation and prevent irresponsible innovation.
The consultation closes on 25 April 2014.
For further information or advice, please contact Charlotte Mawdesley on 0121 456 8402.
Patient matters: best interests
Court of Protection allows campaigner Manuela Sykes to return home despite possible risks to her safety
Readers with an interest in the living arrangements of patients who lack capacity will be aware that we have
included updates on Court of Protection (CoP) judgments that illustrate that the court will not shy away from allowing a patient to return to their home, even where it is assessed they lack capacity to decide where they should reside and that following their wishes includes an element of risk. The decision of Manuela Sykes continues this trend.
Manuela Sykes was a well-known political figure earlier in her life. In 2011, she appointed a close friend as her property and affairs attorney under a lasting power of attorney (LPA). Within the LPA, she stipulated that she would not like her attorney to sell her property. Her wish was to remain in her property for as long as was feasible.
At the time of the judgment, she was 89 and suffering from dementia. She had been admitted to a nursing home in December 2012. She was deprived of her liberty at the home via a standard authorisation. It was reported that, following outings, she settled back in quickly and had never “actually attempted” to discharge herself.
On numerous occasions, she had expressed the wish to return to her own home, a flat in central London where she had lived for 60 years. The local authority had refused a suggested trial of care within her home on the basis that 24/7 care was necessary but prohibitive financially.
Westminster Council brought an application to the CoP in order to have their standard authorisation for DoLS reviewed (via section 21A Mental Capacity Act 2005). Ms Sykes had been observed prior to her admission to the nursing home to be non complaint with care, having altercations with neighbours and suffering self-neglect. She was also prone to wandering and lacked awareness about her own personal safety.
The court concluded that “several last months of freedom in one's own home at the end of one's life is worth having for many people with serious progressive illnesses, even if it comes at a cost of some distress”. Ms Syke's strong wish was for her case to be publicly reported in her own name.
The judge referred to the recent guidance from the CoP relating to the transparency of judgments, which outlines that in general judgments and hearings will be conducted in public. It is worth noting that Ms Syke's profile was a deciding factor in this. The judge noted that it was her "last chance to exert a political influence that is recognisable as her influence. Her last contribution to the country's political scene and the workings and deliberations of the council and social services committee that she sat on." It is worth noting that the expectation should now be that NHS and other professional parties may now be named publicly, as can the names of expert witnesses.
Assessing the best interests for a person in relation to where they should live can involve a difficult balancing exercise for providers. Equally, commissioners must ensure that there is a sufficient auditing process in place to satisfy itself that a patient is not deprived of their liberty unlawfully and that proposals with regard to place of care are made on the basis of a best interests assessment that includes the incapacitated person's wishes, feelings, beliefs and values. The case also illustrates that where there appears to be a disagreement about a placement and/or a standard DoLS authorisation, consideration should be given to a CoP application being made. It is also
Jehovah's Witness oral decision to refuse life sustaining treatment upheld
The matter of Newcastle-upon-Tyne Foundation Trust v LM was heard recently in the Court of Protection (CoP) by the Honourable Mr Justice Peter Jackson.
The case concerned the lawfulness of withholding blood transfusions from a Jehovah's Witness patient, LM, who was very unwell. The treatment in question was considered to be life sustaining.
LM who had a history of mental illness had been a Jehovah's Witness since the 1970s. On 6 February 2014, she was found wandering outside her home in a confused state and transferred to hospital.
On 11 February 2014, she suffered a large bleed from a duodenal ulcer. Testing indicated a dangerously low haemoglobin level and a blood transfusion was recommended. A senior nurse from the liaison psychiatry team assessed LM as showing no signs of active psychotic illness but some mild confusion.
On 12 February 2014, she was seen by two gastroenterologists. She said she was adamant that she would not consent to treatment involving blood products. She was assessed as having capacity. The hospital's advance decision form does not appear to have been provided to her to complete but her wishes were noted in her records. It appears she was clear that she would refuse treatment, even if her life was at risk.
On 13 February 2014, she suffered a significant deterioration, prompting an application to the CoP by the trust. The application was for a declaration that it would be lawful to withhold blood transfusions from LM. The trust was of the view that LM had been clear in her wishes and was aware that refusing blood products could lead to her death. The trust outlined that as an alternative argument, the trust would not wish to act against her wishes, on the basis of respecting her individual dignity.
Of note, the hearing was conducted via a video link, on the basis of the urgency of the matter. At this stage, LM had profound anaemia. The judge declared it lawful for the doctors treating LM to withhold blood transfusions or administration of blood products notwithstanding that such treatments might prevent her death. He was of the view that a decision had to be made there and then and indicated full reasons would follow at a later date.
LM died a few hours before the judgment was provided in full.
The judge outlined that his view was that prior to the afternoon of 13 February, LM had capacity to decide whether to accept or refuse a blood transfusion. There was no evidence that her underlying mental illness rendered her unable to make a decision. He was satisfied that she understood the nature, purpose and effects of the proposed treatment, including that refusal of a blood transfusion might have fatal consequences. He was satisfied that she intended for her decision to apply in the circumstances that eventually arose. On that basis, LM made a decision that the doctors caring for her had rightly decided must be respected.
As outlined above, the trust had sought to advance an alternative argument, in the event that their first line of argument (ie, that respecting LM's wishes on the basis of capacity) was not successful. The court's view was that if LM had not made a valid, applicable decision, it would have granted the declaration sought on the basis that to order a transfusion would not have been in her best interests. Her wishes and feelings and her longstanding beliefs
This case highlights key issues in relation to both assessing capacity and considering treatment for gravely ill patients. These include:
- The fact that a patient has an underlying mental illness does not mean they will lack capacity to make decisions about physical treatment.
- If time permits, discussing treatment options with a patient ahead of time/when they are most able to comprehend relevant information is important.
- The court can be engaged on an urgent basis and with a flexible format (here via a video link) if a decision is genuinely urgent.
- If possible, it would always be preferable to have a patient provide a written advance decision that complies with the requirements of the Mental Capacity Act 2005 in order to provide greater clarity around care. In the absence of a valid and applicable advance decision, detailed and clear notes should be made in the patient's records in relation to their wishes and feelings.
It is also advisable to consider whether or not you require advice in relation to the lawfulness of the proposed treatment plan.
Patient matters: inquests
High Court rejects attempt to judicially review a coroner in mid-inquest; criticises such attempts and rules they should only be allowed in exceptional circumstances
In coroners' inquests, as in many other types of hearing, the court has to make legal rulings as the hearing
progresses, before the issues are finally resolved. In a jury inquest, for example, the coroner may rule that s/he is going to allow the jury to consider conclusions such as unlawful killing, or neglect. One or more of the interested persons at the inquest may disagree with that ruling, because it leaves them open to a very damaging conclusion.
In recent years, there have been several cases where an aggrieved interested person has persuaded a coroner to adjourn the inquest after making such a ruling, to allow a challenge to be made at the High Court, seeking a judicial review of the coroner's ruling. We can be sure there are others where coroners have refused to adjourn. The arguments in favour of adjourning are based on fairness to all parties, if there is genuine debate as to whether
a particular conclusion should be left to the jury, why not get certainty on the issue, rather than risking a conclusion that might be wrong in law, and forcing the parties to challenge it at that stage? The problem, of course, is the significant delay that it causes, and the problems of re-assembling an inquest jury months after they have heard the evidence, asking them to come to conclusions based on fading memories.
In the case of Cooper v HM Coroner for North East Kent, the High Court has come down firmly against the idea of challenging coroners' decisions midway through inquests. The case relates to an inquest with an unusual
history, concerning a death on a construction site. The coroner originally decided not to leave the conclusion of unlawful killing to the jury, but adjourned the inquest while the Crown Prosecution Service (CPS) considered whether to bring criminal charges. Once the CPS decided not to prosecute, the coroner then informed the parties
in writing that she had changed her mind and was going to allow the jury to consider an unlawful killing conclusion. She gave no reasons for her change of heart, nor has she allowed the interested persons to make further submissions to her.
The claimant, doubtless concerned at the implications of a possible conclusion of unlawful killing, sought to challenge this decision but was unsuccessful. The court refused permission for a judicial review, that is refused even to hear argument on the coroner's decision. While acknowledging that there may be some highly exceptional cases where it might be necessary to bring a challenge mid-inquest, the court listed the problems caused by adjourning inquests partway through and ruled that the practice should in almost all cases stop. Mr Justice Mitting said that no judge could ever say that no such case can ever be brought, but he set the bar very high for allowing such challenges to proceed. He stated: "challenges of this kind should not in the ordinary case be entertained by the High Court...I find it difficult to envisage circumstances in which this court should ever entertain such a challenge."
Interestingly, he went on to offer some words of advice to the coroner, perhaps not surprisingly, he advised that she set out the reasons for her change of mind and allows legal submissions to be made on the issue of whether she is right to now leave this issue to the jury.
This decision should be broadly welcomed by healthcare providers. While it deprives them (and all other types of interested person) of the chance to challenge a coroner's decision midway through an inquest, other than in truly exceptional circumstances, such challenges are of course available after the end of a hearing if the jury does in fact return a damaging conclusion. The benefit of this decision is the removal of the prospect of very long and costly delays in the inquest process, leaving an unfinished hearing hanging over the heads of organisations and of their staff who have had to give evidence.