Cambridgeshire and Peterborough CCG

3. Mr E complains about the Cambridgeshire and Peterborough Clinical Commissioning Group’s (the CCG) decision to refuse to fund a removal of an obstructive lipoma on his right breast. He says:

· he met two of the exceptional criteria, however this has never been considered by the CCG

· the CCG did not acknowledge or investigate the level of pain or restriction of movement the problem causes him

· the CCG did not address the size of the lipoma and it changed in the documents

· the CCG made its decision before it met with him in June 2020

· the decision was guided by NHS resource constraints rather than a medical need

· he believes had he been a woman, he would have been granted funding for this.

4. Mr E says he continues to suffer pain and a reduction of movement due to his lipoma. He says the pain affects him every day at work. He says other areas of his body are also affected due to a forced unnatural posture which he developed trying to avoid hitting his lipoma. He says the rejection decision strained his family’s finances as they attempt to save for surgery for him. He says he is embarrassed by ‘what looks like a breast developing on one side’. He says he is no longer able to undress in front of his wife and their relationship lost its intimacy as a result. He says he is unable to play with his young child as quite often it causes him pain. He says he changed emotionally, and he feels let down by the health system. He says his wife had to get a job to try and save money for private appointments and surgery. He says his lipoma grew larger since he was refused funding.

5. Mr E would like the CCG to reconsider their decision into the funding of his lipoma removal.

6. Mr E has a lipoma on his right breast.

7. On 19 October 2019, a consultant oncoplastic breast surgeon diagnosed Mr E’s lipoma as a benign (non-cancerous) lesion.

8. On 16 December 2019, Mr E’s GP submitted the Individual Funding Request (IFR) to the CCG to surgically remove the lipoma.

9. The CCG refused the funding on 30 December 2019. Mr E appealed the decision. The CCG confirmed it upheld its decision on 19 March and then 29 May 2020 following a further appeal.

10. On 10 June 2020, Mr E and the CCG had a one-to-one appeal meeting. The CCG upheld its decision again on 29 June 2020.

11. On 10 July 2020, the CCG provided a stage three appeal response involving a medical director and chief nurse review. The CCG confirmed its original decision and refused the funding.

The funding refusal

14. During the primary investigation stage, we look at whether there are signs the CCG has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and we have not found any indications that something has gone wrong.

15. Mr E says the CCG has not made an appropriate decision as he met two criteria to receive the funding. Specifically, he says his lesion ‘significantly impacts function’ and it ‘causes pressure symptoms’.

16. He says the CCG did not acknowledge or investigate the level of pain, restriction of movement, and the size of the lipoma. He also says the size of the lipoma changed in the documents.

17. Mr E says the CCG made its decision before the appeal meeting in June 2020 and that the decision was guided by NHS resource constraints rather than a medical need.

18. Finally, Mr E believes the decision was discriminatory as had he been a woman, the funding would have been granted due to the location of the lipoma.

19. We are sorry to hear of Mr E’s doubt at whether his funding request was considered in line with the policy and the information he provided. We appreciate the difficulties he says he faces due to the lipoma.

20. It is not our position at the Ombudsman to question the policy in place, but to determine if this has been applied appropriately and the process followed as expected.

Is the CCG’s funding policy in line with any applicable NICE guidance?

21. The National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012 (Regulations), paragraph 34, says CCGs are responsible for funding healthcare treatment in their local areas. The CCG has discretion to set reasonable criteria to determine what will, and will not, be available in their area.

22. In line with the Regulations, paragraph 35 says the CCG’s policies must comply with relevant guidance from the National Institute for Health and Care Excellence (NICE).

23. The CCG’s Exceptional and Individual Funding Request (IFR) policy (paragraph 1.1) states that individuals have ‘the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you’.

24. The CCG’s Benign or Soft Tissue Lesions policy refers to the NICE guidelines on ‘Suspected cancer: recognition and referral’.

25. The NICE guidelines specify that where skin lesions are determined to be malignant (cancerous) or indicated to be, the correct pathway referrals should be made within certain timescales.

26. This confirms that, in line with the NICE guidance, surgery would be funded in these cases only.

27. The CCG’s IFR policy (paragraph 5.11.1) also states IFR will be approved where the CCG concludes there are likely to be no similar patients to the requesting patient, and there is sufficient evidence to show that the proposed treatment is likely to be clinically effective and cost-effective.

28. As Mr E’s lipoma is benign (non-cancerous), it was necessary for the funding to be requested in line with the CCG’s IFR process for approval to be granted.

Has the CCG followed its own funding policy?

29. The IFR policy (paragraph 5.6.1) says ‘the application must be made by a clinician providing NHS service’. The GP made a funding request on 16 December 2019 on behalf of Mr E. This is in line with the process.

30. The request provides written support and evidence in line with the IFR policy (paragraph 5.6.3). It explains the lipoma is ‘troublesome due to its superficial nature and location’ as it gets ‘unavoidably and recurrently’ knocked and as a result it becomes painful. It details its non-cancerous nature, location, size, and Mr E’s history of multiple lipomas.

31. The CCG’s Benign or Soft Tissue Lesions policy says where there is no diagnostic uncertainty, the benign skin and soft tissue lesions are to be treated only if a patient meets at least one out of seven criteria which stipulate the lipoma causes a clinical problem. It says it will not consider treatment to improve appearance.

32. It says, to satisfy the criteria, the lesion must be ‘unavoidably and significantly traumatised on a regular basis with evidence of regular bleeding or infections requiring two or more courses of antibiotics per year’. Alternatively, there must be ‘a repeated infection requiring two or more antibiotics per year’, or ‘bleeding due to normal everyday activity’.

33. Otherwise, the lesion must ‘obstruct an orifice or impairing field of vision’, or ‘impact on function’ (for example restrict joint movements), or ‘cause pressure symptoms’ (for example on nerve or tissue), or ‘if untreated, a more invasive intervention would be required’.

34. Mr E says he met two criteria to receive the funding. Specifically, he says his lesion ‘significantly impacts function’ and it ‘causes pressure symptoms’.

35. The IFR policy (paragraph 5.11.5) says ‘the IFR Panel shall determine, based upon the evidence provided to the panel, whether the patient has demonstrated exceptional clinical circumstances’.

36. On 30 December 2019, the CCG refuses funding as ‘no evidence of exceptionality has been demonstrated’. This is in line with its policy.

37. The appeal of 18 March 2020 includes further information on Mr E’s lipoma. The letter advises the lipoma is growing, and that there are several others on the chest and abdomen area. It elaborates on the physical discomfort and pain, and the psychological impact the lipoma has on Mr E.

38. The CCG’s response of 19 March 2020 upholds its decision to reject the funding. It states, ‘no new evidence has been demonstrated’. The appeal request and provided response is in line with the first stage appeal consideration as per the IFR policy (paragraph 5.14.1).

39. Between the 21 May and 3 June 2020, the CCG and Mr E exchanged emails regarding the CCG’s decision. Mr E elaborates on the physical and psychological impact he suffers due to the lipoma. He explains his clinical exceptionality. He explains his financial situation will not allow a private solution to his medical need. The CCG rejects the appeal and suggest a one-to-one meeting between the Panel and the patient in line with the second stage appeal consideration as per IFR policy (paragraph 5.14.2).

40. The IFR policy (paragraph 5.14.2) says the purpose of the meeting is to ‘explain the CCG’s policy and process, and the reasons that the IFR Panel reached its decision not to approve funding’. It says the meeting is an opportunity to ‘listen to the concerns of the patient and answer any questions they may have’, and ‘for the patient to provide any new information that was not presented… before’.

41. On 10 June 2020, Mr E and the CCG had a one-to-one meeting via Teams. The meeting is in line with the IFR policy.

42. On 11 June 2020, Mr E emails the CCG explaining further his rationale. He explains the lipoma restricts movement of his right arm as he ‘constantly swings to avoid catching it yet again’. He also explains he experiences ‘pain from the pressure it causes frequently’. He refers to his financial situation.

43. On 29 June 2020, the CCG rejects the funding request advising the information provided does not bring any new clinical information.

44. On 10 July 2020, the CCG provides a stage three appeal response which involves a medical director and chief nurse review. It agrees with the original decision and refuses the funding. This is in line with the third stage appeal consideration as per IFR policy (paragraph 5.14.3).

Our view

45. Mr E says he met two criteria to receive the funding. Specifically, he says his lesion ‘significantly impacts function’ and it ‘causes pressure symptoms’.

46. We are sorry to hear of Mr E’s funding request being rejected.

47. The IFR policy (paragraph 5.11.5) says the Panel is to determine exceptionality based on the clinical evidence.

48. We note the CCG considered all the information provided by Mr E and his GP. The CCG followed the process and gave Mr E sufficient opportunity to fully present his case. It made a decision in line with its IFR policy. Sadly, the funding was rejected for clinical reasons.

49. Mr E says the CCG did not acknowledge or investigate the level of pain, restriction of movement, and the size of the lipoma. He also says the size of the lipoma changed in the documents.

50. We are sorry to hear of Mr E’s doubt of whether his funding request was considered in line with the information he provided.

51. The CCG’s IFR policy advises that, ‘you have the right to expect local decisions on funding of other drugs and treatments to be made rationally following a proper consideration of the evidence’ (paragraph 1.1).

52. We note the CCG considered all the information provided by Mr E and his GP in line with its IFR policy.

53. In terms of investigation and size, we note it is not the role of the CCG to investigate or assess Mr E’s symptoms. It is the responsibility of a patient and their GP to provide a full clinical picture when requesting funding. This is in line with the IFR policy (paragraph 5.6.3).

54. Mr E says the CCG made its decision on funding before the appeal meeting in June 2020.

55. We are sorry to hear of Mr E’s frustration with the IFR process, however, the purpose of the meeting was to explain the process, rationale of the decision, answer questions, and allow new evidence, if any. As such, we consider the meeting was in line with the IFR policy (paragraph 5.14.2).

56. Mr E says the CCG’s decision was guided by NHS resource constraints rather than a medical need.

57. We are sorry to hear of Mr E’s doubt whether his medical need was considered.

58. The Regulations 2012 says CCGs have discretion to decide on the reasonable criteria which define what will, and what will not, be funded in its local area. The rationale for such policy is to allow allocation of resources for persons for whom the CCG has responsibility.

59. We found no evidence the CCG has not followed the relevant policies and regulations. As such, we consider the CCG declined funding in line with its discretion to do so.

60. Mr E says he believes the location of the lipoma would make the CCG agree the funding had he been a woman. He says the decision to refuse the funding was discriminatory.

61. We are sorry to hear of Mr E’s belief that the CCG was discriminatory in its decision-making.

62. The IFR policy (paragraph 5.11.7) says the CCG ‘does not discriminate on ground of sex’ when making a funding decision. It says it will consider a patient’s gender only ‘where a treatment has a differential impact as a result of [it]’.

63. We have not seen any evidence the CCG considered Mr E’s gender when making its decision to refuse the funding. The rationale is based on the clinical information.

64. In summary, we are very sorry to hear of the difficulties Mr E faces due to his lipoma and the surgery funding refusal. It appears the CCG gave full consideration to the evidence provided, but sadly, the funding request was declined for clinical reasons.

65. Overall, we do not have any grounds to ask the CCG to reconsider its decision because it has followed the process that we would expect it to follow. We have seen nothing to suggest there has been a service failure.

66. As such, after completing a primary investigation, our view is that there is no further action we can take on this complaint.

1. We have carefully considered Mr E’s complaint about the Cambridgeshire and Peterborough Clinical Commissioning Group (the CCG). We would like to take this opportunity to say how sorry we are to learn of the reasons behind Mr E’s complaint. We have reviewed all the relevant evidence and we have seen no indication that anything went seriously wrong.

2. We are satisfied the CCG considered all the information provided by Mr E and his GP. We consider the CCG followed the process adequately and gave Mr E sufficient opportunity to fully present his case. We are satisfied the one-to-one meeting in June 2020 was in line with the CCG’s funding request policy. We believe the CCG was not discriminatory in its decision.