Breast Reduction as Low Priority
17. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not found any indications that something has gone wrong.
18. The ICB’s role is to decide when to fund treatments that are not routinely commissioned by the NHS. Ms R says the ICB has decided that breast reduction is a low priority procedure and therefore it will be funded only in exceptional circumstances. The ICB’s criteria for a low priority procedure is set out in its Commissioning Policy. It states low priority procedures are: • ‘when they are ineffective or do more harm than good • when there is no evidence of being effective • when the treatment is effective but only for patients with specific characteristics, or when resources would be better used for procedures which carry a better balance of benefits to patients in the same group.’
19. Ms R complains the ICB have incorrectly interpreted the evidence of clinical and cost-effectiveness of breast reduction surgery and in doing so, incorrectly deemed the procedure to be low-priority. She explains there is significant research which shows breast reduction is effective in reducing symptoms caused by macromastia and is more cost effective that other treatments.
20. Ms R says all individuals who experience symptomatic macromastia should be entitled to the treatment.
21. Ms R also points out the ICB has done Joint Comprehensive Impact Analysis (JCIA) on its policy. This states ‘all patients who satisfy referral criteria will be entitled to the service.’ She says as breast reduction does not fit low-priority criteria, it is a treatment which satisfies the referral criteria. Therefore, all patients needing breast reduction, should be entitled to the service.
22. In the ICB’s complaint response it explained the policy reflected national evidence-based guidelines and was due for a review.
23. We looked at the relevant information to understand how ICB’s should operate when considering how to fund treatments which are not routinely commissioned by the NHS. the National Health Service Act (2006) is relevant to this issue. It states, ‘in making a decision about the exercise of its functions, NHS England must have regard to all likely effects of the decision in relation to… efficiency and sustainability in relation to the use of resources by relevant bodies for the purposes of the health service in England.’
24. Additionally, the role and responsibility of integrated care systems (ICS) and integrated care boards (ICB) is relevant to understand what should happen. NHS ICS’ are local partnerships which bring different health organisations together and create and deliver a shared strategy. ICBs operate within an ICS and plan delivery of services on the local level.
25. One of the responsibilities of an ICS is to help the NHS enhance value for money. More specifically, ICBs plan health services for a local population while managing its NHS budget. We can see the ICB should be making decisions about treatments, while considering NHS budgets. Therefore, it should be making sound economic decisions, when deciding what non-routinely commissioned treatments it will fund.
26. The ICB’s website explains as demand of care is growing, it must give priority to clinically and cost-effective treatments and so difficult decisions are made about what the ICB can afford while ensuring the ICB’s spending, benefits the most people.
27. The ICB should be making local policies about treatments that are not routinely commissioned. It should be making these decisions, bearing in mind NHS budgets. This means it will have to make decisions not fund to some treatments.
28. To understand how the ICB defined breast reduction surgery as one which should not be normally commissioned we asked the ICB why it considered breast reduction surgery to be ‘low priority’.
29. The ICB explained to us that breast reduction surgery is considered a low priority procedure as it meets the fourth criteria of low-priority treatments. It uses resources that would produce more value if invested in some other service for the same group of patients.
30. It also explained the JCIA is an assessment done after the policy is put in place. The criteria it refers to is not the ‘low priority’ criteria, but the ICB’s criteria for granting funding and further referral. This is outlined as follows:
• There is no cohort, and the case is clinically exceptional in which case the ICB agrees to fund one off treatment for the individual as an exceptional case.
• There is a cohort and ICB agrees to fund this case because of the clinical evidence of exceptionality provided.
31. This means the JCIA report does not say, if the treatment is not low priority, all patients should have access to treatment. It says if the application meets one of the two above criteria, patients should then have access to treatment.
32. We can see the ICB has a responsibility to make decisions over a finite resource and to make choices about whether to fund treatments not routinely provided in the NHS. Breast reduction treatment is deemed to use resources which could be used more widely for other patients with symptomatic macromastia. For this reason, the ICB decided it will not be routinely commissioned.
33. The ICB did not deem breast reduction surgery to be ineffective or without adequate research (relevant to its three other criteria). Those were the decisions Ms R challenged as she had evidence that breast reduction was well-researched and reported to be effective.
34. Instead, the ICB deemed breast reduction to be low priority because resources (such as funding) would be better spent on another service for those affected (with the possibility that other services may offer a better balance of benefit to harm). That is not to say breast reduction is harmful, but that other services which could be funded to help the wider group of patients with the condition, may have less risk attached.
35. Based on the information we have seen; we do not see evidence the ICB has incorrectly deemed breast reduction to be low priority. Additionally, we do not see evidence the ICB are failing to meet its JCIA report. The report Ms R has identified, refers to criteria related to a cohort or exceptionality, rather than definitions of what is low priority. Overall, the evidence indicates the ICB acted in line with relevant policy. We do not see any indications of a failing with this issue and will be unable to take it further.
Clinical Exceptionality
36. Ms R tells us that when she applied to the ICB for funding for breast reduction surgery, it told her she had not provided evidence of clinical exceptionality. Her application was rejected at triage stage and was not considered by clinicians.
37. Ms R said as part of her application, she provided information from her GP, physiotherapist, psychologist, photographs, and an individual statement. She says all this information showed the severity of her condition, how significantly it was impacting her life, and her chronic secondary pain was unable to be treated by usual methods.
38. We have looked at the ICB’s funding request policy to understand what should have happened. The policy says the panel ‘will consider requests to fund where there is evidence of exceptional clinical need’. It also says the funding request must come from a clinician, and they should show the patient’s condition is significantly different to others who have the condition. The clinician should also show how the patient would benefit more than others if treatment was funded.
39. The policy says at triage stage the application should be completed fully, the clinician must make the case of the patient, clinical evidence should be provided and clinical papers where relevant.
40. The ICB will refuse the application at triage stage, when exceptional clinical need has not been demonstrated. It will also refuse it, when there is not enough evidence provided to support the application and when the evidence shows the patient would not benefit from treatment more than anyone else.
41. We also asked the ICB what standards it uses to make its assessments at triage and application phase. It directed us to the AMRC’s guidance on ‘Breast Reduction’. This guideline says breast reduction will only be provided when the patient has already received a full package of care from their GP. Patient must also have had a physiotherapy assessment; demonstrate their breast size results in functional symptoms (such as kyphosis). And that the functional symptoms require other interventions, and other criteria. Kyphosis is excessive curvature of the upper spine.
42. To understand what happened when Ms R’s application was submitted, we reviewed the application sent, and the ICB’s complaint correspondence. The application to the ICB included a letter from Ms R’s GP. The GP stated Ms R’s clinical need was great. The GP wrote in the application Ms R’s bra size, inability to exercise, impact on her mental health and the development of Functional Neurological Disorder (FND). FND is a disorder where the brain does not send and receive messages properly to the body. There is emphasis on how her breast size is affecting her mental wellbeing and ability to function well in society.
43. Where the IFR application asks how the patient is different to others with the condition, the GP explained there were no bras that could fit Ms R’s chest and cup size, inability to engage with physiotherapy for symptomatic relief, direct impact of macromastia on FND and that Ms R’s potential could not be reached because of the condition.
44. There was also a report from a psychologist, a personal statement from Ms R and a physiotherapy report. The physiotherapy report stated Ms R presents with kyphotic thoracic spine and protracted shoulders.
45. In its response on 28 September 2023, the ICB explained it could not consider Ms R’s statement as it is only able to consider evidence from the clinicians. It said applications cannot be considered because of psychological impacts from the condition. This is because these should be treated by relevant mental health services.
46. This meant the psychologist’s report could not be considered nor Ms R’s statement. The references to mental health in the application could not be considered. This is in line with the AMRC’s guidance which does not include consideration of mental health impact.
47. The response said the physiotherapist’s report was helpful, but other information was needed. We can see that the physiotherapist explained Ms R had kyphosis but did not explain why it needed further intervention (as outlined in the AMRC guidance).
48. The ICB said types of evidence it needed were patient notes which evidence visits to the GP or secondary care, clinical photos, bust measurements (rather than bra size), imaging, secondary care referrals, evidence that all other options have been explored and that the condition impacts on the functionality of the patient’s life.
49. We can see from the evidence available, the ICB needed more information about the clinical impact of the condition on Ms R’s physical wellbeing to assess clinical exceptionality. We can see the personal statement and psychologist report would not have been considered as evidence.
50. We can see the application did not include medical records or referral information. Information about how all other options had been explored, including, for example, inability to take medications, and prescription records could have been helpful.
51. There was some information about how the condition affected the patient’s functionality in the physiotherapy report. However, while the physiotherapist reported issues with kyphosis, information about whether this condition needed intervention, would also be needed.
52. We can see the application gave some necessary information. However, the ICB needed more clinical evidence to demonstrate that Ms R was more significantly impacted by the condition than others, and that treatment would significantly improve her outcomes, compared to another with the same condition.
53. The ICB has explained for a patient to evidence impact and improvement of their outcomes, the GP needed to send further information, as outlined. We can see the physiotherapist could also have discussed whether intervention was needed for kyphosis.
54. Based on the evidence we have seen, the ICB seemed to follow its policy in reaching its decision. We see no indications of failings with this issue.
Application Requirements for Funding Requests
55. Ms R says the ICB told her the evidence for her application did not meet its threshold to evidence of clinical exceptionality. She complains the ICB has not explained what information it needs, for the application to have sufficient evidence. Ms R says she is allowed to put in a new application; however, she does not want to until she knows what information is needed.
56. To understand what should happen when communicating about a selection process, we have consulted our Principles of Good Administration. The relevant guidance in this is that ‘public bodies should give people information and, if appropriate, advice that is clear, accurate, complete, relevant and timely.’
57. We can see the ICB was clear about its policy. It said it only considered funding if a referring clinician showed the patient was different to other similar patients and the applicant would benefit more than others from treatment. We can see it was initially clear about clinicians needing to provide evidence.
58. In the original application form, the ICB explained it cannot consider surgery based on evidence of a psychological impact. It was clear that discussion of psychological issues would not be considered.
59. The ICB’s complaint responses show there was other specific information it needed but it had not outlined these in the policies and forms. It said in responses, specific measurements of bust and body, clinical photographs and medical records, were needed. The response said the medical records should demonstrate the condition affected the patient and the patient had tried all other options available.
60. From the clinician’s application form and the ICB decision letter, we can see the evidence the ICB needed was not explained to the original GP making the referral. By not providing this information, the ICB was not giving complete information to clinicians, as our administration standards outlines. For this reason, we see indications of failings.
61. When we see indication of failings, we consider if there are signs of an impact. If there are, we consider if the organisation has done anything, to put the issues right. The failure to communicate information has caused Ms R to put her best efforts into the application without indication of what to provide. This has caused frustration and further delays to possibly getting treatment for pain caused by macromastia.
62. Our NHS Complaint Standards say when things go wrong, organisations should ‘identify suitable ways of putting things right.’
63. We can see from the ICB’s responses, that it did not uphold Ms R’s complaint and because of this it did not propose to make any changes. We spoke with the ICB on 5 August 2024 and 2 September 2024. It explained the ICB has now updated the application form to include a section that states that measurements and clinical photography should be included in applications for breast surgery. It said Ms R’s complaint highlighted the need for the ICB to be clearer on the forms.
64. The ICB has also explained Ms R is able to send a new application providing the information it has set out in its complaint response.
65. We have reviewed the new application form. We can see that the ICB have outlined the evidence to include in applications, including relevant medical records, scans, photos assessments and measurements. It has also included an appendix for clinicians who are applying for a patient to be funded for breast surgery. The appendix outlines the measurements it requires to make its assessment about clinical exceptionality.
66. The ICB has acted to remedy issues in communicating the evidence it needs to make an assessment. We think the new information on its application form, resolves the issue. It has also provided more detail about information it needs and what the evidence should show, in responses to Ms R. It has welcomed her to put in a new application. The actions are, in our view, as close to those Ms R seeks as we could achieve for her.
67. Based on the changes made to the application form, information provided in responses and invitations to Ms R to apply again, we think the organisations has done enough to put the issue right. For this reason, we do not propose to take this issue further.
Criteria for Clinical Exceptionality
68. Ms R explains she has been invited to apply again for funding for breast surgery by the ICB. She says it requires patients to show clinical exceptionality, however the ICB will not share what criteria it uses to make this judgement. Ms R says, without the criteria the applicant is disadvantaged. She says without this information clinicians and patients must guess what evidence they should provide, to show clinical exceptionality.
69. Ms R says while the ICB has said it is difficult to define what is normal and therefore exceptional, information is freely available showing when a patient’s breast size is outside a normal range. This includes the NHS website. She complains the ICB says there is no set criteria for showing clinical exceptionality, and each case is considered in a case-by-case basis. However, there is a strong evidence-base and published material which tells people what the symptoms and signs are of breast size being a clinical issue.
70. The ICB has said assessment of clinical exceptionality is made on a case-by-case basis and because all cases are different, it cannot set parameters and definitive criteria to what is an ‘exception’. It has said exceptionality is something unusual and therefore, cannot be defined.
71. To understand how applications should be assessed, we asked the ICB what guidance it adheres to, when writing its funding policy on breast reduction. It directed us to AMRC’s ‘Breast Reduction’ standards. The standards say breast surgery should not be provided if the criteria it lists, is not met. It does not say if the criteria are met, that surgery must or should be provided.
72. The criteria include patients have already received a package of care, a physiotherapy assessment, functional symptoms which require intervention etc, as discussed above.
73. Our Principles of Good Administration are also relevant here. The relevant standard to this issue is that ‘public administration should be transparent, and information should be handled as openly as the law allows.’
74. We can see the ICB has not provided information about the AMRC’s standards on what criteria must be met before breast reduction can be considered. We spoke with the ICB on 2 September and asked why it did not share this information and whether this might be possible. We also asked if it could provide more detail on what makes a case of macromastia exceptional.
75. It explained, while the AMRC guidance is part of its consideration, it still has to make further judgements about whether someone had demonstrated clinical exceptionality after considering those factors.
76. It said judgements were made by clinicians and would take into consideration how an issue was affecting a patient and whether, for example, it was hindering their basic functioning. It explained that might be different from one patient to another, even if two patients had a condition with similar markers.
77. The ICB explained this using a lipoma as an example. A lipoma is a benign tumour of fat. The ICB said a lipoma may be equally large for two patients, but one might be on someone’s eye, affecting their sight. The other might be on a patient’s neck and not affecting functionality.
78. For this reason, the size of the lipoma is not relevant, its impact on the patient is the deciding factor. We can see from the ICB’s explanation a set criteria would not capture whether the condition was impacting one patient more significantly than others in the same cohort. This is why assessments are made on a case-by-case basis.
79. We can see how two patients may have equally sized breasts and have macromastia. But one patient may have a different body shape, weight and height, and this combination of factors, could cause them functional issues. However, another patient with macromastia and the same size of breasts as the other patient, may have a body shape, weight and height, which means their breast size does not affect them to the degree their functionality is affected.
80. As such details are numerous and nuanced. Clinicians would have to consider all those factors together, and not simply the patient’s breast size and height for example. We understand conditions can present in a range of different ways and impact patients variously. We understand this is what the ICB clinical team must consider when assessing IFR applications. We think it is reasonable that the ICB do not have a specific criteria for assessing a patient’s morphology as exceptional, when considering breast reduction surgery.
81. We can also see why the ICB do not publish the AMRC’s guidance. The guidance is only part of what the panel must consider. It must also consider the other exceptional circumstances meaning the patient would benefit from treatment more than others. Publishing the information may mislead patients that fulfilling the AMRC’s guidance, is enough to demonstrate clinical exceptionality. We can see this is not the case.
82. On this basis, we think the ICB’s explanation of how it assesses is accurate. It says it does this on a case-by-case basis and we can see this is likely true. The assessment of an individual’s condition is a nuanced and necessarily individualised process. For this reason, there is no specific criteria it can provide.
83. We consider the ICB’s policy provides information about how decisions are made, as transparently as it should and meets our standards. For this reason, we will not be taking this issue further.
84. We recognise our decision may be upsetting for Ms R. She is very keen to get treatment for macromastia and wants to put forward the best case she can. To do this she would like clarity on what information and detail will help her application to be successful. This is entirely understandable.
85. We hope our decision has explained where her complaint has helped to improve the service of the ICB. Particularly, in making changes to the information it provides about applications for breast reduction. This will benefit Ms R and other patients. We also hope we have clearly explained why we have not seen indications of failings in other areas, and why we think the ICB cannot do more to explain its decision-making process.
86. We wish Ms R all the best with her future treatment and thank her for bringing this complaint to us.