BHA response to NHSE consultation

Please find below our response to the recent NHSE consultation, or click to download the full response as a pdf.

Clinical Commissioning Policies

5 Please indicate which clinical commissioning policy you would like to comment on:
Hyperbaric Oxygen Therapy
Clinical Commissioning Policies (continued)

6 Has all the relevant evidence been taken into account?
No

If you selected ‘No’, please give details:

The evidence reviews are deficient in two main areas.

The first is a failure to distinguish between clinical trials in which the intervention and control groups have received appropriate treatments and those in which they have not, despite clear guidance on these matters from clinicians experienced in the use of hyperbaric oxygen and who have a sound knowledge of the basic research and clinical practice to justify their advice. As a result, irrelevant evidence has been allowed to influence conclusions.

The second is a failure, despite strong support from non-hyperbaric clinicians who use our services, to take into account evidence from sources other than randomised controlled trials for conditions in which the numbers of patients and / or the heterogeneous nature of the condition precludes such trials. In the opinion of the British Hyperbaric Association, this approach is not consistent with the principles of evidence-based medicine and promotes an ideal (that has long been discredited) ahead of a genuine desire to enhance outcomes of care.

The Association’s members consider that it is inappropriate that NHS England has used of a lack of data from randomised controlled trials as a justification to dismiss existing modest evidence of benefit and strong non-hyperbaric clinician opinion in support of continued use.

Furthermore, the paradox has arisen that NHS England has accepted decompression illness and gas embolism as routinely funded indications in the absence of any supporting evidence from randomised controlled trials, yet does not accept conditions such as diabetic foot ulcers, carbon monoxide poisoning and late radiation tissue injury, for which favourable evidence from randomised controlled trials exists if it is interpreted with appropriate insight.

In its report dated 17 February 2016, NHS England’s Clinical Panel concludes that there is insufficient new evidence identified in the evidence review to change the commissioning position. If this is the case, why has the panel endorsed a change in the commissioning position which now excludes carbon monoxide poisoning and makes no mention of the current policy to fund treatment costs of HBOT in other indications where these are “part of well-designed multi-centre trials that will answer questions of clinical and cost effectiveness”?

7 Does the impact assessment fairly reflect the likely activity, budget and service impact?

No

If you selected ‘No’, please tell us what is accurate?:

Limiting the use of Hyperbaric Oxygen Therapy to decompression illness and gas embolism will lead to the breakdown of well-founded pathways, the development of which required significant investment in terms of hard work and many hours of training. An interruption in these referring pathways will take years to restore to a position where the most deserving patients are referred in good time.

8 Does the policy proposition accurately describe the current patient pathway that patients experience?

No

If you selected ‘No’, what is different?:

The policy proposition refers the reader to the service specifications which describe the current patient pathway for decompression illness in detail. The pathway for gas embolism casualties will be very similar except that referrals will generally be only from medical practitioners in secondary or tertiary care facilities. The pathways for conditions that NHS England proposes should not be routinely commissioned, however, are not described. In view of our earlier comments, these pathways should not be omitted.

9 Please provide any comments that you may have about the potential impact on equality and health inequalities which might arise as a result of the proposed changes that have been described? Please provide any comments that you may have about the potential impact on equality and health inequalities which might arise as a result of the proposed changes that have been described?:

If the worst-case situation arises and some hyperbaric facilities become non-viable, time to treatment will increase for patients in the areas where facilities cease to operate, resulting in poorer outcomes for seriously ill and / or progressively deteriorating cases of decompression illness and gas embolism. The increase in distance travelled for treatment will incur additional transport costs for NHS England, will place a greater burden on valuable assets such as ambulances and helicopters, and will dilute the service available for transportation of patients with serious illnesses and injuries which are not dive related.

We are also concerned that many of the patients hitherto treated for conditions for which NHS England now proposes that hyperbaric oxygen therapy will not be routinely commissioned come from small populations of cancer survivors and others with a range of long-term severely debilitating conditions which limit the patients’ capacity to represent themselves in an online consultation. Thus, in our opinion, those with the greatest need are being denied access to treatment without adequate consideration of their views of what they want from a health service.

10 Are there any changes or additions you think need to made to this document, and why?

NHS England appears to be reluctant to permit the practice of true evidence-based medicine in fear of spiralling health care costs, hence the limitation on routine commissioning for conditions other than decompression illness and gas embolism. British Hyperbaric Association members are distressed by the fact that, while the numbers of patients who genuinely require hyperbaric oxygen therapy are very small, the numbers are sufficient to make cohorts and so Individual Funding Requests are most unlikely to be approved. We work very carefully with non-hyperbaric clinicians to select patients for whom hyperbaric oxygen therapy is likely to be of benefit and, even if commissioning restrictions were relaxed, we do not envisage that activity would increase sufficiently to cause overall national costs to increase. In order to accommodate our observations on evidence based medicine, the impact of reduced activity on effectiveness and safety and the disproportionate effect on vulnerable patient groups, we recommend that the document should permit treatment for individual patients conditional upon approval by a multidisciplinary expert panel which would ensure that hyperbaric oxygen therapy is available for all those patients who need it most while limiting national costs to historical levels. If any unit were to exceed its anticipated quota for a particular indication, the provider would bear the additional cost.

While the impact assessment does reflect most of the likely impact on activity, budget and service, we remain concerned that the process to date does not include the development of appropriate mitigations against the potentially catastrophic disruption of the service for providing even those treatments that NHS England proposes should be commissioned routinely. We understand from the impact assessment that these mitigations are likely to be formulated within the service review and, in order to avert a significant degradation to patient care and safety, we strongly advise that the proposed commissioning policy is not implemented before the service review delivers its recommendations and that this condition is made clear in the document.

Final question

11 Before completing the survey you must declare any financial or other interests in any specialised services.

The British Hyperbaric Association (BHA) is an unincorporated association, full membership of which is open to hyperbaric facilities in the British Isles run by organisations that accept and treat emergency referrals for hyperbaric oxygen (HBO). Members pay a subscription to the Association. No individuals, apart from an Honorary Secretary when appointed, receive any remuneration for their work on behalf of the BHA. All funds received are used to pursue the objectives of the BHA which are as follows:

• To further the use of hyperbaric treatments according to best practice;
• To encourage and maintain high standards in the provision of hyperbaric oxygen therapy and therapeutic recompression;
• To publish information that relates to the safe and effective provision of hyperbaric oxygen therapy in the British Isles;
• To maintain records relating to the volume and efficacy of hyperbaric activity in the British Isles;
• To engage with other professional bodies with relevant interests in hyperbaric medicine and therapy;
• To provide a forum for discussion of hyperbaric therapy with particular consideration of:
  • Clinical Indications;
  • Therapeutic Standards;
  • Audit and Research;
  • Funding;
  • Management;
  • Issues specific to the British Isles;
• To encourage best practice by peer-group review and dissemination of relevant medical advances.
• To represent Hyperbaric medicine at national and international levels and provide a co-ordinated overview of hyperbaric activity in the British Isles.
• To convene Scientific Meetings.

In view of the foregoing, most individuals within the BHA including myself will work for a provider and will have a financial interest in the hyperbaric oxygen therapy service. It is noteworthy, however, that many of the hyperbaric clinicians receive no additional remuneration for accepting extra patients for treatment and that there is absolutely no financial incentive for the non-hyperbaric clinicians who refer emergency cases or take part in multidisciplinary teams that refer elective patients.