Meeting of Bristol Clinical Commissioning Group Governing Body

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1 Meeting of Bristol Clinical Commissioning Group Governing Body To be held on Tuesday 26 April 2016 commencing at 1:30pm at the Vassell Centre, Gill Avenue, BS16 2QQ Title: Commissioning of Homeopathy Agenda Item: 16 1 Purpose To inform a Governing Body discussion and decision on the medium and long term plan for commissioning Homeopathy. 2 Background Bristol, North Somerset and South Gloucestershire (BNSSG) CCGs commissioned a review of Homeopathy services to help inform a decision on the future commissioning arrangements. This review is attached (appendix one) to this paper along with a brief covering note. The review considered a number of options, and was discussed at the BNSSG Partnership meeting. At this meeting the CCGs agreed to ask their decision making bodies to consider plans for Homeopathy. This proposal focused on a recommendation that each CCG undertook a public engagement exercise and that if all three CCGs agreed on this course of action a single engagement exercise be considered. It was noted that each CCG would need to consider the resource implications associated with such an exercise. The agreed policy paper is attached for information. 3 How have service users, carers and local people been involved? The review involved an interview with a patient and considered other forms of patient feedback. 4 Implications on equalities and health inequalities. Any decision regarding the commissioning arrangements for a service and ant associated public engagement exercise would need to take into account equalities and health inequalities.. 5 Evidence Informed Commissioning A previous evidence-based review was undertaken in BNSSG on the efficacy of Homeopathy. This is referenced in the attached review. The attached review considers patient feedback, activity data and clinical professional views. The suggestion to undertake a public consultation is considered best practice when potentially making material changes to the commissioning of services. 6 Financial Implications If you need this document in a different format telephone the CCG on Page 1 of 2

2 Meeting of Bristol CCG 26 April 2016 Commissioning of Homeopathy There is a, as yet unknown, resource implication in relation to the proposed public engagement exercise. 7 Legal implications In making any decision regarding the commissioning arrangements for a service the CCG must have due regard to the legal duties set out in the Health and Social Care Act Risk implications, assessment and mitigation The risks are outlined in the review paper. 9 How does this fit with Bristol CCG s Operational Plan or Strategic Objectives? This service is not referred to in the CCG Operational Plan. 10 Recommendation(s) The Governing Body is asked to agree that: A public engagement exercise on the future commissioning of Homeopathy is completed and Consider a joint public engagement exercise with North Somerset and South Gloucestershire CCGs North Somerset and South Gloucestershire CCGs are also considering this decision, and if all agree to this recommendation it is suggested that one public engagement exercise is undertaken across all three CCGs. Consider the resource requirement for a public engagement exercise Sarah Swift Delivery Director, SCWCSU 18 March 2016 Martin Jones Clinical Chair, Bristol CCG 18 March 2016 Page 2 of 2

3 Bristol, South Gloucestershire & North Somerset CCGs' review of Integrative Medicine 1. Purpose of this document This document has been written on behalf of Bristol, North Somerset and South Gloucestershire (BNSSG) Clinical Commissioning Groups (CCGs). Its purpose is to present information that will assist in a BNSSG review of the NHS homeopathy services commissioned from University Hospitals Bristol NHS Foundation Trust. On 6 August 2015 a meeting of BNSSG CCG representatives was held, to define this review. The brief was then agreed by the Partnership Group of the three CCGs in October The Partnership Group has no decision-making authority, and thus any decisions on the future of homeopathy commissioning must be made by each CCG independently. This document aims to: 1. Review the needs of the patients currently accessing homeopathic services commissioned by BNSSG CCGs, and 2. Appraise the options for commissioning arrangements to best meet the needs of these patients. The document does not set out recommendations, but is intended to give sufficient information to enable a considered decision to be made. 2. Executive summary Medically-led homeopathy has had a long and, right from the start, controversial history in the wider Bristol area. People who seek NHS homeopathic treatment are: predominantly women or children; mostly people who are seeking alleviation of long-term symptoms; reported as often finding the treatment of value. Referrals are mostly from GPs, and, contrary to expectation, geographically quite widespread across the local area. The simple arguments 'for and against' can be summarised as 'we are still looking for the explanation, but it works for me' versus 'it doesn't make any sense medically, and so we should be spending the money on something else.' Conversations with referrers show more modulated views and behaviours: there are clinicians who don't 'believe it' medically but nevertheless refer. The provider of the NHS service is sub-contracted for this work from University Hospitals NHS Foundation Trust. The provider is in transition to a social enterprise. This brings opportunities for change, as well as complexities around contracts and employment. Recent CCG commissioning changes include a local commissioning policy, which has probably been the cause of a recent reduction in referrals. 1

4 The paper reminds decision-makers of the considerations they need to take in making a decision, and cautions against simplifying the decision into a for-or-against debate. Any decision, including the status quo, will have implications for patients and for staff. Decision-makers are also reminded that there other consequences, but these may not necessarily be constitutionally legitimate or primary grounds for a decision [e.g. legal consequences, reputation, management time]. In summary, this decision is not a puzzle with a right or wrong answer, but a challenge to the quality of decision-making. 3. Scope and exclusions In scope Review of the needs of the patients currently accessing the NHS homeopathic service provided by University Hospitals Bristol Appraisal of future options for these patients Out of scope Review of complementary and alternative medicines which are not homeopathic Homeopathy services provided by others, such as high street retailers and non-nhs practitioners Demand and capacity modelling of other referral pathways i.e. describing the knockon effects of any commissioning changes e.g. on pain clinic referrals Assumptions stated in the brief for this document: Clinical evidence on the efficacy of homeopathy has not changed since July Therefore, the [South West] CSU s July 2014 review of homeopathic evidence will be accepted as sufficient for the purposes of this review. 4. Recent BNSSG homeopathy commissioning reviews In 2010/11 work was undertaken by the local Primary Care Trusts with Bristol Homeopathic Hospital to review the levels of activity and explore the potential for a policy to be introduced around homeopathy. A policy was worked up that was intended to reduce new referrals from the BNSSG area. Discussions were also held with the service about the follow-up ratio, and the optimum number of follow-up appointments. In 2014 the service was again reviewed 1. Discussions were held with the homeopathic service, and a clinical commissioning policy was agreed in principle, which was to be taken to the individual BNSSG CCG Boards for decision. The policy was expected to reduce activity by approximately 30-50% if applied as 'Prior Approval' being required for each new referral. 5. How the service is currently commissioned Following the 2014 local review, South Gloucestershire and North Somerset CCGs adopted the proposed policy; it was not adopted by Bristol CCG. The current arrangement is thus: 1 Recorded in minutes of Bristol CCG meeting 29 July

5 CCG Type of Policy Further details Criteria North Somerset and South Prior Approval (PA) A process that requires the referrer to obtain prior authorisation for patients who meet the criteria. If the patient See Appendix 16 2 Gloucestershire demonstrably meets the criteria, then the application must be forwarded to the Commissioners for approval - and confirmation of funding received before a referral is made. Bristol Open Referrals are passed directly from the referrer to the provider None The current policy for North Somerset and South Gloucestershire CCGs states: The CCG has accepted that there are some circumstances where the referring clinician and their patient consider homeopathic management to be the appropriate means of managing their health condition. All requests to fund such referrals will be assessed individually and evidence of clinical effectiveness will be taken into account. 6. The local NHS homeopathy service Homeopathy has been offered in the Bristol area since the 1850s. From 1902 a service ran from a hospital in Brunswick Square; from it was run from the Bristol Homeopathic Hospital; and then from the new South Bristol Community Hospital. Practitioners were invariably qualified doctors, and the current service is also medically-led. Currently all approved referrals from GPs or local secondary care clinicians are passed to the single, local NHS homeopathy service 3. This service is commissioned by the BNSSG CCGs from University Hospitals Bristol (UHB). Features of the local NHS homeopathy service include: Outpatient service only [i.e. no beds] Appointments for both adults and children Clinician-led, including doctors and occupational therapists Patients are offered a first appointment and then no more than four follow-up appointments. Around a third of patients do not use all five appointments. In certain circumstances, such as long-term cancer, a further four appointments are available. Until recently the service was wholly part of University Hospitals Bristol. By mutual agreement, the lead consultant Dr Elizabeth Thompson developed a plan to offer a wider integrative medicine service [e.g. acupuncture], with homeopathy as part of this, and for the whole to become a social enterprise. As the business model relied on a large proportion of NHS referrals, aspects of 'due diligence' and the 2014 review of homeopathy held back this plan for a while. The plan came to fruition in 2015, and the service is now provided by the Portland Centre for Integrative Medicine (PCIM), an employee-owned social enterprise. The service runs from premises in Clifton. It is effectively a 'sub-contractor' of University Hospitals Bristol. The PCIM is in a transition phase in its relationship with University Hospitals Bristol. This has enabled both the 'due diligence' and employment aspects to so far be managed thus: 2 Also see 3 There are also non-nhs providers, but the referral criteria used mean that no referrals have been made to these since the inception of the commissioning policy 3

6 PCIM are responsible for the operating costs of running their services, which is offset by the outpatient tariff received for appointments. This is paid monthly as 1/12 of predicted annual income. Administrative and clinical staff remain University Hospitals Bristol staff, and are seconded to PCIM. For technical reasons, this is until March 31st In summary, patients receive NHS funded appointments, in much the same way that other local services are run by non NHS organisations, such as the Community Interest Companies running community health services in each of the local CCGs. The aspiration of PCIM to offer a broader range of integrative medicine services is mentioned later in this paper. 7. The needs of patients: why do patients and doctors refer? The lead consultant for the service, Dr Elizabeth Thompson, describes some of the typical presentations for which people seek homeopathy: Children: eczema; autism; anxiety; behavioural disorders; chronic fatigue; postural hypertension Adults: depression; menopausal symptoms; vertigo ; anxiety; unstable mood; control of symptoms or side effects in cancer treatment; irritable bowel syndrome; post-viral fatigue; rheumatoid arthritis What are the outcomes that people seek and the benefits they experience? The brief for this paper did not include consultation with patients, but we have interviewed a local patient to illustrate the patients perspective: I'd always had chronic allergies - I'd been in hospital all through childhood. This meant, as an adult, I was allergic to dust, food and other unidentifiable causes. I had to live in virtually hermetically sealed rooms; I couldn t sleep in the same room as my wife; I had itches; used inhalers; couldn t have a dog, and I was off sick from work a lot. I was on antihistamines, but they weren't having much of an effect, and the only avenues my GP could explore - higher doses, allergy tests - weren't getting anywhere. As a research scientist I had always considered it a pseudo-science I couldn t believe there was a whole hospital devoted to it when I drove past once, and that it was on the NHS. I used to think this was an absolute joke. But I decided to ask my GP for a referral I was sceptical but desperate. I had an appointment and was prescribed and I went from not being able to function to everything working in two days. This was the first summer I had gone hay fever-free for my entire life... and that was three summers ago. I was trying other self-help things too cleaning up my diet, for example. I charted some of my main symptoms, and my diet made 10-15% difference, whilst the homeopathic remedy was 90%. I thought this can't just be the placebo effect. Because I am a scientist, I couldn t believe it, so I asked a friend at work to do a blind-trial on me. I got him to give me water or a homeopathic remedy; within 2-3 days my symptoms would improve, but with water they came back. But what's the future of homeopathy? Where is the voice? It needs to be kept a lifeline until the science becomes clearer. 4

7 In compiling this report, referring GPs said that people are not led to expect a 'miracle cure', but more a relief from the symptoms with which they are living, or treatment of side effects. The brief for this paper does not include further reviewing the published evidence of the comparative effectiveness of homeopathy vis a vis other treatments/placebos. However from the patients' perspective, it is useful to note a recent study 4 undertaken by the local homeopathy service on the outcomes reported by 200 patients. In this study there was a significant reduction in 'problem symptoms' and an increase in reported well-being [as described in the quote above]. There are a number of ways of categorizing the needs of people who are referred for homeopathy. As well as categorizing people by their medical conditions, a local clinician describes it thus: As a GP you know there is little else you can do with conventional medicine. They have a significant, chronic problem but not usually diagnosed. I will have done a full range of tests CT scan, X ray etc and there appears to be no significant cause. The other main group of patients is those who are very aware of integrative medicine and request homeopathy at an early stage. The first of these categories can include medically diagnosed conditions (e.g. depression) where conventional medicine is not being effective for that person, as well as 'medically unexplained symptoms.' 5 Regarding the second group mentioned in the quote above, in a study of 100 patients undertaken by the local homeopathy service, five were reported as seeking homeopathy because they would not/never use conventional or 'allopathic' medicine, whilst the remaining 95 were primarily seeking a holistic approach to their health. In summary, it seems as though the majority of people using the service are those for whom conventional medicine has either run its course, or failed to unearth medical causes of continuing pain, concerns or symptoms. Some of these are seeking an approach that they see as holistic and safe, particularly when given alongside other conventional interventions. A minority wish, from the start, to eschew a conventional 'allotropic' approach. 8. What do we know about the population who are referred for homeopathy? At population level, data are available on, for example, gender, age and place of residence. Whilst none of these is a ground for decisions about commissioning, the data illustrates the diversity of people being referred. The data below are drawn from all recorded applications for referral from people registered with a BNSSG GP practice [both direct referrals from a GP and those from a secondary care clinician]. The period is December 2014 November 2015, and the total is Carried out by Dr David Spence, using the Measure Yourself Medical Outcome Profile [MYMOP] 5 Medically unexplained symptoms (MUS) is the term used to refer to disorders where the patient s physical symptoms have no medical explanation. 5

8 Number Gender profile women men Age profile Referrals by age 116 referrals across BNSSG Dec November Age For interest, though clearly not a ground for commissioning decisions, Appendix 17 shows the referral rate from BNSSG GP surgeries [including those who are referred by a secondary care consultant.] Nothing about clinical need can be drawn from this data, but it does show that the population is widespread and not concentrated in one area. 6

9 M1 2013/14 M2 2013/14 M3 2013/14 M4 2013/14 M5 2013/14 M6 2013/14 M7 2013/14 M8 2013/14 M9 2013/14 M /14 M /14 M /14 M1 2014/15 M2 2014/15 M3 2014/15 M4 2014/15 M5 2014/15 M6 2014/15 M7 2014/15 M8 2014/15 M9 2014/15 M /15 M /15 M /15 M1 2015/16 M2 2015/16 M3 2015/16 M4 2015/16 M5 2015/16 M6 2015/16 M1 2013/14 M2 2013/14 M3 2013/14 M4 2013/14 M5 2013/14 M6 2013/14 M7 2013/14 M8 2013/14 M9 2013/14 M /14 M /14 M /14 M1 2014/15 M2 2014/15 M3 2014/15 M4 2014/15 M5 2014/15 M6 2014/15 M7 2014/15 M8 2014/15 M9 2014/15 M /15 M /15 M /15 M1 2015/16 M2 2015/16 M3 2015/16 M4 2015/16 M5 2015/16 M6 2015/16 9. How many people use the service? To illustrate any trend in referrals, figures have been aggregated for the BNSSG CCGs. New and follow-up appointments are shown below, for the last 2.5 years, up to the most recently available data: New Outpatients Activity Follow-up Outpatients Activity A linear trend line has been applied to the New Activity data. Using this (although not a wholly reliable tool), the data can be interpreted to read that there has been a downward trend in activity. One possible cause, as was intended, is the implementation of Prior Approval for referrals from South Gloucestershire and North Somerset CCGs. 10. What is the cost of referrals? Comparative data on activity and cost 6 are available for 2013/14 and 2014/15. For 2013/14 this data is for all ages; for 2014/15 it is available split by adults and children. Data for this current year-to-date can also be made available; at month 6 the forecast total activity for the year is, for all three CCGs, lower than that in 2014/15. 6 Speciality no:0770 HRG ID Homeopathy 7

10 2013/14 Work type Description Value Volume NHS Bristol CCG Follow-up Outpatients 111, New Outpatients 34, NHS Bristol CCG Total 145,420 1,236 NHS North Somerset CCG Follow-up Outpatients 19, New Outpatients 4, NHS North Somerset CCG Total 24, NHS South Gloucestershire CCG Follow-up Outpatients 19, New Outpatients 4, NHS South Gloucestershire CCG Total 24, /15 Work type Description Value Volume NHS Bristol CCG Adults Follow-up Outpatients 101, Adults New Outpatients 19, Paediatrics Follow-up Outpatients 23, Paediatrics New Outpatients 5, NHS Bristol CCG Total 149,819 1,299 NHS North Somerset CCG Adults Follow-up Outpatients 21, Adults New Outpatients 4, Paediatrics Follow-up Outpatients 5, Paediatrics New Outpatients 1, NHS North Somerset CCG Total 31, NHS South Gloucestershire CCG Adults Follow-up Outpatients 22, Adults New Outpatients 3, Paediatrics Follow-up Outpatients 2, Paediatrics New Outpatients NHS South Gloucestershire CCG Total 29,

11 11. What are the options for commissioning local homeopathy services? The main options are set out below. They are not mutually exclusive. For example, Option D would take time to develop, and therefore an interim decision based on the other options would need to be made. Equally, Option C, for example, could be decided on for a limited time and then reviewed [all IFR reviews have a date for review]. Option A: no change Option B: cease commissioning NHS homeopathy services Option C: continue but with altered approvals policy Option D: to continue to offer referrals but as part of a wider well-being service Continue to commission, using the same approach to referrals i.e. prior approval for patients in South Gloucestershire & North Somerset, and open access for those in Bristol. In addition to a simple cessation of NHS referrals, a further sub-option arose in discussion, that of having homeopathy available (only) through Personal Health Budgets [PHB]. It would be a way of meeting some patients' needs alongside a decision to cease direct commissioning. One clinician stated: PHB is about well-being, and thus this detaches it from the medical scientific criticism. If the clinical and patient agree this will help, then the PHB is used; there are many private homeopaths, and so the patient could use these. This would also move away from the position that the CCGs are commissioning from one provider. CCGs are currently planning the implementation of national policy, whereby PHBs "will be extended to those with long term conditions (including mental health conditions) who could benefit." The policy describes this as: The provision of greater choice and improving the personalisation of treatment, via opening up a wider range of non-traditional treatment options as alternatives to NHS services for people with ongoing conditions. If this option were chosen it would be a way of meeting some patients' needs, as part of managing the impact of Option B 7. Continue with referrals to the service, but introduce either Prior Approval [for Bristol] using the criteria used by the other two CCGs or Individual Funding Requests [for all or any of the CCGs]. A further option is to develop different criteria Homeopathy is most frequently sought by those with a long term condition, and Option D has arisen from discussion with commissioners and individual clinicians. Homeopathy would not be seen as a discrete service, but as one of a range of options [not necessarily from one provider]. Referrals would still be offered but as part of a wider 'holistic' wellbeing service; in the words of a commissioner, 'for people where treatment doesn t fit into a straight medical interpretation. This might include talking therapies. Currently the service offered via UH Bristol is almost too specific' One commissioner said of the current provider 'They provide a range of services that look potentially far more interesting from a CCG perspective, not least NICErecommended mindfulness-based cognitive therapy'. This would be a planned change as part of a wider commissioning strategy around self care and long term conditions. How such a service would be commissioned and from whom is a matter for further discussion. Commissioners would need to consider how they could support a range of 'Any Qualified Providers' in this field. 7 A commissioner further developed this proposal: I would want to see a consistent commissioning approach to complementary treatments,.. this is best approached from the perspective of increasing choice and personalisation via the development of Personal Health Budgets. The introduction of PHBs will potentially provide access to a greater range of non-traditional treatments that patients may wish to take up instead of mainstream NHS services. It would be consistent with enabling greater patient choice to fund homeopathy, only when agreed as part of a package of care under a PHB. 9

12 The option of removing the current prior approval policy is not explored here, as it was seen to be very unlikely to be approved by local CCGs. 12. What issues need to be considered in any possible changes in commissioning? CCGs' constitutions require them to make decisions based on a number of criteria. The most relevant, taken from the local constitutions & local policies are summarized below: 1...commissioning (certain) health services that meet the reasonable needs of.. all people registered with member GP practice 2. Take an evidence-based approach utilising public health and clinical advice 3. act effectively, efficiently and economically, with particular respect to commissioning decision making, procurement and financial procedures 4. A duty of equality 5. Adhering to national and local policies The following sections list these key considerations required of CCGs in their decision-making. Each option is appraised in the light of these factors. Any views expressed are based on discussion with some of the key stakeholders listed in the Appendix The needs of patients Section 7 described some of the health needs for which patients seek treatment through a referral to homeopathic services 8. There is no doubt that a proportion of people who have received treatment feel that it has been beneficial. In compiling this report, experienced clinicians have described two perspectives on this need, and the impact of Options B or C [further restriction or withdrawal of the service]. If people are not referred, their need doesn t go away. It is most likely that the patient will continue to request multiple investigations, multiple visits to primary care and to secondary care outpatients. So the consequences of withdrawing the service are a remaining unmet need. This type of service has been running for a long time, and it has been valued by some it has not suddenly become dangerous. This view highlights that the effect of stopping a service that is valued by some is not simply like turning off a tap. Some kind of need remains, and if this is to be met then that, too, would bear a commissioning cost if it were to be met by the NHS. A counter argument expressed is that: I referred a patient with ME. [But] we already offer services for some of these long term issues such as the Chronic Fatigue Service. We do offer acupuncture on the NHS, which has a better evidence base. If people want to use, for example, a chiropractor, they know they have to pay. Despite the clinical & financial argument [about its evidence base and whether it should be funded] neither of these clinicians denied a need exists; the difference of opinion is over the method of supporting and funding this. 8 The brief for this paper excluded surveying patients needs, and so any views about patients in this section simply present the broad views available in written papers and via clinicians 10

13 One further view, on behalf of patients, was expressed: 'if you offer homeopathy you might be blocking/slowing down their journey to something more effective.' In summary, the implications of the options for the needs of patients are: Option Option A: no change Option B: cease commissioning Option C: continue but with altered approvals policy Option D: offer referrals but as part of a wider well-being service Implication and issues Current and future patients treated in the same manner The patient needs as described above would need to be met with other treatment options; or patient expectations managed, or needs met privately without NHS funding Reduced service, and thus much of Option B would still need to be addressed Discussed further in section 12.5 National and local policies 12.2 Duty to ' take an evidence-based approach utilising public health and clinical advice' The most frequently used view to support Option B (removing funding for referrals) is the quality of the evidence base for homeopathic treatment. Those who refer to a number of reviews and meta-reviews conclude that homeopathy is: Not effective no better than a placebo or a glass of water Not cost-effective [obviously not, if it is not deemed effective] Misleading for patients who will then not accept other treatments One commissioner said 'I certainly don t think the same rigour has been applied to Homeopathy as we would expect from a new cancer drug, for example.' Those, such as the Homeopathy Research Institute, who take the view that it is a valuable treatment, say: There is evidence that other very commonly used treatments [e.g. SSRIs] are 'no better than placebos', and yet they are widely used There are studies which show a significantly reduced use of conventional medicines by patients A considerable number of other treatments have a lower burden of proof we still use them, but we just don't understand how they work yet Observational studies show that patients report improved health The brief for this paper is to refer to the local CCGs review of the evidence (Appendix 18). Generally, the most commonly quoted NHS paper is the House of Commons Science and Technology Committee's Evidence Check 2 Homeopathy. A useful quote from this makes the distinction made between efficacy and effectiveness; We have set out the issue of efficacy and effectiveness at some length to illustrate that a non-efficacious medicine might, in some situations, be effective (patients feel better) because of the placebo effect. That is why we put more weight on evidence of efficacy than of effectiveness. In summary, the implications of the options for the duty to take an evidence based approach are: 11

14 Option Option A: no change Option B: cease commissioning Option C: continue but with altered approvals policy Option D: offer referrals but as part of a wider well-being service Implications and issues The CCG would attract criticism from some of its GP members 9, as well as from others within and outside the local health community This option would satisfy CCG Governing Bodies where the criterion of 'evidencebased' is their main factor in decision-making This option would not substantially change the current commissioning approach that local CCGs have adopted Discussed in section 12.5 National and local policies 12.3 Duty to act effectively, efficiently and economically, with particular respect to commissioning decision making, procurement ' The annual costs of outpatient referrals to the local service are shown in section 10. There is no suggestion that the current service could be commissioned for a significantly lower cost. In appraising the options against this duty there are two viewpoints that local stakeholders have raised. One viewpoint is the 'opportunity cost' i.e. with a limited budget there are other NHS treatments which CCGs could commission/expand if this was not spent on homeopathy 10. Clinicians described services in other clinical areas that they would like to offer, that are limited by funding, such as the Community Heart Failure Service. Other clinicians described the missed opportunity to invest more in services specifically related to the typical problems of homeopathy patients, such as acupuncture. The alternative viewpoint expressed is to take the total cost of a full 'pathway of care', rather than homeopathy being a stand-alone cost. One stakeholder said: I m sure there are difficult and/or impossible to assess medical treatments (less so surgical treatments) that cost the NHS and the CCG far greater sums of money than the obvious attributable costs of Homeopathy. As Homeopathy is also seen almost as a last resort option, the cost of treatments up to and including Homeopathy itself maybe should be considered. It may well be that Homeopathy is actually a more cost-effective placebo than a continuation of traditional prescription medicines. In summary, the implications of the options for the duty to act efficiently and economically are: Options Option A: no change Option B: cease commissioning Implications and issues The service would continue to cost around 117 per person for a completed treatment This option would release money to off-set against savings requirement or reinvest in 9 GPs form the membership of the CCG. Whilst views have not been sought comprehensively, local GP leaders are of the view that the majority of members do not accept homeopathy is sufficiently evidence-based. This is not to be confounded with a view that it should not be used, as some GPs hold both views. 10 One clinician stated: 'we are not denying you want homeopathy, we are not denying you might benefit, but [the CCG is] not paying with tax payers money' 12

15 Option C: continue but with altered approvals policy Option D: offer referrals but as part of a wider well-being service other services. For the reasons described earlier, patients would still seek treatment for their symptoms, and thus the savings would be less than the total current homeopathy spend. This option would reduce the spend Discussed in section 12.5 National and local policies 12.4 Duty of Equality If changes are to be made to commissioning i.e. Options B, C & D, then expert advice is that an equalities impact assessment would need to be made National and local policies In making a decision on homeopathy commissioning, the local CCGs need to take account of national policies and their local strategies, policies and operational plans. The most relevant for the patient group being considered are those relating to the support of self-care, especially for people with a long term condition. The national Five Year Forward View and each of the BNNSG CCGs have this as an important part of their strategy. Homeopathy is most frequently sought by those with a long term condition, and Option D has arisen from discussion with commissioners and individual clinicians. This would be to continue to offer some referrals but as part of a wider 'holistic' well-being service. 13. Practical and managerial issues Each of the options brings a number of practical consequences. These may or may not be factors of which a CCG needs to take account in discharging its duties. In brief, these include: 13.1 Public consultation Expert advice is that any change to the service will require public consultation. This would be for a minimum of four weeks. For a substantial change, such as Option B, cessation of commissioning, consultation would include working with the wider public, not just those currently using the service The impact on the providers [UH Bristol and PCIM] and staff Options B (cease commissioning) and C (continue but with stricter criteria, which would be likely to lower referrals) could make the sub-contractor PCIM unviable. There is a level of referrals at which it is not viable for the fixed costs of employing staff. Although PCIM's plan is to build their portfolio [e.g. further 'Kitchen on Prescription' work on nutrition and obesity; and mindfulness services] the great majority of their current income is from local NHS referrals for homeopathy. If these options were implemented so swiftly as to make the service unviable, then there are contractual and employment consequences. There would need to be a staff consultation carried out by the employer, which remains UH Bristol, as the staff are seconded. Redundancies would be avoided if possible, but there are liabilities [e.g. for pensions] held by UH Bristol. It is understood that UH Bristol would be willing to see the provider PCIM move to being fully independent from its current transition phase, once the sharing of the risks and liabilities is agreed and the service is viable. If the commissioning of the service remains in doubt, then it is unlikely that there would be sufficient 'due diligence' to enable staff to be fully transferred and be employed by PCIM. 13

16 For option B (cessation) the sub-contract would need to be extended beyond March 31 st 2016, if the commissioners decide to honour a commitment to existing patients' follow-up. UH Bristol would need a 'contract variation' if this were the case Challenges to the CCGs' decision The commissioners are likely to face challenges to a decision to continue in some form, and also if they decide to cease commissioning. These challenges may come from: GP members of the CCG The local public and specific local stakeholders Current users of homeopathy services Lobbying groups or organizations. Most notably, these could include the Good Thinking Society and the British Homeopathic Society Commissioning issues Because of the risk of the challenges mentioned above, it may be unwise to enter into a full one-year contract with UH Bristol until both a decision has been made and the practical implications understood in detail, particularly the timescales [either a public consultation or a legal challenge will both take several months]. Alternatives to extending the sub-contract with UH Bristol for some or all of 2016/17 include directly commissioning the service from PCIM. 'Commissioning intentions' are the first conventional indication from commissioners to providers before contracts are completed. 14. Options appraisal Section 9 describes the main options in detail. The table below summarises the main issues associated with each of these options. Any decision will attract interest, and the status quo is unlikely to go unnoticed. All of the main options continuing or ceasing commissioning will take managerial time to implement. Any of the options taken will require excellent communication in order to explain the reasons and the consequences. This will include good communications with the public, with staff affected, and with other stakeholders. Some might welcome a local discussion about holistic treatments and selfcare, and see it as an opportunity to explain the CCG's work and aims. Others might count the managerial time that could be spent on other activities. As mentioned above, the options are not mutually exclusive. For example, Option D would take time to develop, and therefore an interim decision based on the other options would need to be made. Equally, Option C, for example, could be decided on for a limited time and then reviewed [all IFR reviews have a date for review]. 14

17 Option A: no change Option B: cease commissioning NHS homeopathy services Option C: continue but with altered approvals policy Option D: to continue to offer referrals but as part of a wider well-being service Issues and implications 1. Provides opportunity for patients to be funded by the NHS 2. Likely to be popular with the current referrers to the service 3. This position does not follow the evidence base 4. Unlikely to be popular with some clinicians who are seeking funding for other evidence based treatments 5. Negotiations required with provider (UH Bristol) to address issues of due diligence and employer liability as PCIM moves to full independence 1. Those patients who would have been referred to the service may take up more NHS resource by being referred to multiple other services; may be increased non-concordance with medications for those patients 1. This position follows the evidence base 2. This provides a clear and defendable statement 3. Requires a managed cessation to allow the provider time to change the service to being for privately patients 4. Unlikely to be popular with former users of the service, and those wishing to access the service on the NHS 5. Unlikely to be popular with those referring to the service 6. Would require public consultation & equalities impact assessment 7. UH Bristol would need a 'contract variation' to ensure current patients can complete their treatment beyond March 31 st This provides some opportunity for patients to be funded by the NHS 2. Those patients using the service may take up more NHS resource by being referred to multiple other services 3. This position does not follow the evidence base 4. This policy is unlikely to be popular with the local providers of the service and those referring to the service 5. The sub-contractor PCIM may become unviable, and cease; negotiations required with provider (UH Bristol) to address issues of employer liability 8. May be advisable to have public consultation & equalities impact assessment, even if not obligatory 1. This position does not follow the evidence base 2. Likely to be popular with the current referrers to the service 3. The wider service could be designed as a response to CCGs' self-care and long-term conditions strategies i.e. as a planned way of addressing identified need, rather than focussing on stand-alone service 4. Issues of Any Qualified Provider and other commissioning approaches would need to be considered 5. As this option would take time to develop, an interim option would need to be taken whilst this work was completed 6. Would require negotiation with provider to ensure changes were part of a broader plan, and the shorter-term concerns managed and risks shared Author: Martin Howard, South, Central & West Commissioning Support Unit 15

18 APPENDICES 15. Glossary University Hospitals Bristol University Hospitals Bristol NHS Foundation Trust, which is commissioned by the CCGs to provide outpatient homeopathy services. Local CCGs Bristol, North Somerset and South Gloucestershire Clinical Commissioning Groups New and follow-up A new appointment is the first (or first recent) appointment made by a patient with the service. The appointment follows a referral from their clinician (their GP or a secondary care clinician e.g. Breast Cancer Nurse). Follow-up appointments are agreed between the patient and the service. The service the outpatient homeopathy service provided by UH Bristol. CSU South Central &West Commissioning Support Unit, the NHS body contracted by the BNSSG CCGs to provide financial, contracting and other support. Partnership Group the regular meeting between the three BNSSG CCGs where matters of common interest are discussed. The partnership does not have decision-making powers. Types of commissioning policy: IFR - Individual Funding Request Panel (not routinely funded, requires panel decision) CBA - Criteria Based Access (if patient meets criteria, refer directly) PA - Prior Approval (seek approval from CCG and then refer if evidence provided) PCIM - The Portland Centre for Integrative Medicine - 'an employee owned social enterprise, led by healthcare professionals'. Effectively the sub-contractor providing the services discussed in this paper. 16

19 16. Current criteria for approval of referrals by North Somerset and South Gloucestershire CCGs 17

20 Page 2 18

21 17. Where do referred patients come from? 19

22 20

23 21

24 18. BNSSG CCGs' review of clinical evidence 22

25 23

26 24

27 25

28 26

29 27

30 19. Sources of views and information used in compiling this report We wish to thank the following teams and individuals: A local patient South, Central & West Commissioning Support Unit: o Contract and performance management o Individual Funding o GIS (maps) Bristol, North Somerset & South Gloucestershire CCGs: o Clinical Leads/Governing Body chairs o Patient Engagement o Governance o Performance o Equalities o Commissioning o CCG membership Clinical Lead for the provider, the Portland Centre for Integrative Medicine UH Bristol Divisional Director Sample of referring GPs Public Health [for the original evidence review] 28

31 TREATMENT UNDER THIS POLICY REQUIRES PRIOR APPROVAL FROM THE CCG INDIVIDUAL FUNDING TEAM THIS POLICY RELATES TO ALL PATIENTS Homeopathy Policy Statement: Date of Issue: 1 December 2014 The CCG has accepted that there are some circumstances where the referring clinician and their patient consider homeopathic management to be the appropriate means of managing their health condition. All requests to fund such referrals will be assessed individually and evidence of clinical effectiveness will be taken into account. Prior approval must be gained before referring. Policy - Criteria to Access Treatment INDIVIDUAL FUNDING REQUEST APPROVAL REQUIRED Requests will be assessed for funding if the following criteria are met: 1. Severity of the Unresolved Health Issues Where the patient has a significant condition which causes the patient significant health problem(s) which have a severe impact on quality of life, defined as: Symptoms prevent the patient fulfilling routine work or educational responsibilities, or Symptoms prevent the patient carrying out routine domestic or carer activities Or where the patient is a child with significant health problems, significantly affecting family life. AND 2. Treatment Options Where the condition has not been helped by conventional treatment, OR Where conventional treatment is contraindicated, OR Where conventional treatment is unacceptable to the patient and no acceptable alternative is available OR Treatment of side effects of mainstream treatments or medications that would otherwise mean mainstream treatment would cease e.g. cancer treatments NOTE: Homeopathy is NOT commissioned for patients with conditions where the standard commissioned treatment is undertaken in primary care e.g. : facial blushing/ hot flushes, low back pain, mild/moderate cough, allergies, rhinitis (chronic or seasonal), menopausal problems, musculoskeletal pain, insomnia/ interrupted or unsatisfactory sleeping patterns, receding gums, hyperhidrosis. One new appointment and up to four follow up appointments are commissioned for each patient when patients meet the above criteria. Further follow-up appointments would need to be agreed via the Individual Funding Request (IFR) Process. Re-referrals within two years of referral will not be expected, and would also require an IFR application.

32 Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed at the Commissioner s Individual Funding Request Panel upon receipt of a completed application form from the patient s GP, Consultant or Clinician. Applications cannot be considered from patients personally. If you would like further copies of this policy or need it in another format, such as Braille or another language, please contact the Patient Advice and Liaison Service on or This policy has been developed with the aid of the following references and collaborations: (a) Work with the homeopathy service locally (b) A list of evidence for the effectiveness of homeopathic medicine for some illnesses ( and (c) The fact that commissioners have to prioritise mainstream treatments for which there is strong evidence of effectiveness. Developed in Collaboration with Dr Elizabeth Thompson - Lead Consultant Homeopathic Physician and Honorary Senior Lecturer in Palliative Medicine, University Hospital Bristol. Approved by (committee): Clinical Policy Review Group Date Adopted:: 1 December 2014 Version: Produced by (Title) Commissioning Manager Individual Funding EIA Completion Date: Undertaken by (Title): Review Date: Earliest of either NICE publication or three years from approval. Bristol CATEGORY VERSION CATEGORY VERSION CATEGORY VERSION Not North Criteria Based South Criteria Based Adopted Somerset Access Gloucestershire Access

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