Specialised Services Policy: CP07 Hyperbaric Oxygen Therapy Document Author: Specialist Planner for Cardiothoracic Services Executive Lead: Director of Planning Approved by: Management Group Issue Date: 05 March 2013 Review Date: February 2014 Document No: CP07 Page 1 of 17
Document History Revision History Version No. Revision date Summary of Changes Updated to version no.: 1.0 November 2006 Addition of clinical indications where HBOT is the last resort for a small number of patients at highest risk Details of evidence basis for each of the proposed indications 2.0 February 2008 3.0 May 2008 Listing of exact clinical references as the basis for the evidence on which the clinical criteria are defined 4.0 February Re-draft 5.0 2010 5.0 February Transferred onto new template, minor 5.1 2013 amendments made 5.1 March 2013 Ratified through Chair s Action on behalf of Management Group 6.0 Date of next revision February 2014 Consultation Name Date of Issue Version Number 2.0 3.0 4.0 Approvals Name Date of Issue Version No. Commissioning Board 04/03/2010 5.0 Directors 22/03/2010 5.0 WHSSC Management Group 05.03.2013 3.0 Distribution this document has been distributed to Name By Date of Issue Version No. Page 2 of 17
Policy Statement Background Summary of clinical criteria Hyperbaric oxygen therapy (HBOT) is breathing 100% oxygen while under increased atmospheric pressure. When a patient is given 100% oxygen under pressure, haemoglobin is saturated, but the blood can be hyperoxygenated by dissolving oxygen within the plasma. Emergency indications: Decompression illness; Carbon monoxide intoxication; Life threatening anaerobic or mixed soft tissue infections; or Crush injuries and other traumatic ischaemia with comprised circulation. Elective indications: Diabetic foot ulcers; Osteoradionecrosis (ORN) of the head and neck; Prevention of osteo-radionecrosis for head and neck surgery; Soft tissue radiation tissue damage; or Chronic refractory osteomyelitis. Responsibilities Referrers should: Inform the patient that this treatment is not routinely funded outside the criteria in this policy; and Refer via the agreed pathway. Clinician considering treatment should: Discuss all the alternative treatment with the patient; Advise the patient of any side effect and risks of the potential treatment; Inform the patient that treatment is not routinely funded outside of the criteria in the policy; and Confirm that there is contractual agreement with WHSSC for the treatment. In all other circumstances submit an IPFR. Page 3 of 17
Table of Contents 1. Aim... 5 1.1 Introduction... 5 1.2 Relationship with other Policies and Service Specifications.. 5 2. Scope... 6 2.1 Definition... 6 2.2 Codes... 6 3. Access Criteria... 8 3.1 Clinical Indications... 8 3.2 Criteria for Treatment... 10 3.3 Referral Pathway... 10 3.5 Exceptions... 11 3.6 Responsibilities... 11 4. Putting Things Right: Raising a Concern... 13 5. Equality Impact and Assessment... 14 Annex (i)... 15 Annex (ii) Checklist... 16 Page 4 of 17
1. Aim 1.1 Introduction The document has been developed as the policy for the planning of Hyperbaric Oxygen Therapy for Welsh patients. The policy applies to residents of all seven Health Boards in Wales. The purpose of this document is to: Set out the circumstances under which patients will be able to access Hyperbaric Oxygen Therapy services; Clarify the referral process; and Define the criteria that patients must meet in order to access treatment. 1.2 Relationship with other Policies and Service Specifications This document should be read in conjunction with the following documents: All Wales Policy: Making Decisions on Individual Patient Funding Requests (IPFR). Page 5 of 17
2. Scope 1. Purpose 2.1 Definition Hyperbaric oxygen therapy (HBOT) is breathing 100% oxygen while under increased atmospheric pressure. When a patient is given 100% oxygen under pressure, haemoglobin is saturated, but the blood can be hyperoxygenated by dissolving oxygen within the plasma. The patient can be administered systemic oxygen via 2 basic chambers: Type A, multiplace; and Type B, monoplace. Both types can be used for routine wound care, treatment of most dive injuries, and treatment of patients who are ventilated or in critical care. 2.2 Codes ICD-10 Codes Code Category Code Description ICD-10 T70.0 Otitic barotrauma ICD-10 T70.1 Sinus barotrauma ICD-10 T70.3 Caisson disease (decompression sickness) ICD-10 - compressed air disease ICD-10 - diver's palsy or paralysis ICD-10 T79.0 Air embolism (traumatic) ICD-10 T80.0 Air embolism following infusion, transfusion and therapeutic injection ICD-10 T81.7 Vascular complications following a procedure not elsewhere classified ICD-10 - air embolism following procedure NEC ICD-10 T53 Toxic effects of halogen derivatives of aliphatic and aramatic carbons ICD-10 T53.0 Carbon tetrachloride ICD-10 - Tetrachloromethane ICD-10 T58 Toxic effect of carbon monoxide ICD-10 D62 Acute post haemorrhagic anaemia ICD-10 X47* Accidental poisoning by and exposure to other gases and vapours ICD-10 X67* Intentional self poisoning by and exposure to other gases and vapours ICD-10 Y17* Poisoning by and exposure to other gases and vapours, undetermined intent ICD-10 T66 Unspecified effects of radiation ICD-10 K10.2 Osteoradionecrosis of jaw ICD-10 N30.4 Irradiation cystitis ICD-10 L55 - L59 Radiation related disorders of the skin and subcutaneous tissue ICD-10 K52.0 Gastroenteritis and colitis due to radiation ICD-10 M86.4 Chronic osteomyelitis with draining sinus ICD-10 M86.6 Other osteomyelitis Page 6 of 17
ICD-10 K10.2 Inflammatory conditions of jaws - osteoradionecrosis ICD-10 T01.0 Open wounds involving head and neck ICD-10 T01.1 Open wounds involving thorax with abdomen, lower back and pelvis ICD-10 T01.2 Open wounds involving multiple regions of upper limb(s) ICD-10 T01.3 Open wounds involving multiple regions of lower limb(s) ICD-10 T01.6 Open wounds involving multiple regions of upper limb(s) with lower limb(s) ICD-10 T01.8 Open wounds involving other combinations of body regions ICD-10 T01.9 Multiple open wounds, unspecified ICD-10 T14.1 Open wound of unspecified body region ICD-10 E14 Diabetes mellitus (relating to wound). This code would be in addition to the code for the specified wound. ICD-10 T14.7 Crushing injury and traumatic amputation of unspecified body region ICD-10 Crushing injury NOS ICD-10 Traumatic amputation NOS ICD-10 T04 Crushing injuries involving multiple body regions ICD-10 T04.0 Crushing injuries involving head and neck ICD-10 T04.1 Crushing injuries involving thorax with abdomen, lower back and pelvis ICD-10 T04.2 Crushing injuries involving multiple regions of upper limb(s) ICD-10 T04.3 Crushing injuries involving multiple regions of lower limb(s) ICD-10 T04.4 Crushing injuries involving multiple regions of upper limb(s) with lower limb(s) ICD-10 T04.7 Crushing injuries of thorax with abdomen, lower back and pelvis with limb(s) ICD-10 T04.8 Crushing injuries involving other combinations of body regions ICD-10 T04.9 Multiple crushing injuries, unspecified ICD-10 G06.0 Intra-cranial abscess and granuloma ICD-10 A48.0 Gas gangrene (including cellulitis) Page 7 of 17
3. Access Criteria 3.1 Clinical Indications This policy covers emergency and elective indications for HBOT. 3.1.1 Emergency Indications Emergency indications for treatment are: a) Decompression illness / gas embolism; b) Carbon monoxide intoxication; c) Life threatening anaerobic or mixed soft tissue infections; or d) Crush injuries and other traumatic ischemia with compromised circulation. 3.1.2 Elective Indications 3.1.2.1 Diabetic Foot Ulcer All the following criteria apply: After assessment and discussion with the DDRC a relevant MDT believes that: (i) There is a clear case for treatment; (ii) There is a significant probability of successful treatment; and (iii) There is a risk of amputation. Where conservative treatment has not been successful, and no healing has resulted from 6 weeks of intensive management by an expert diabetic wound management team; and/or Where the Wagner score is between 2 and 5. Where trans-cutaneous oxygen monitoring (TCOM) near the wound indicates that tissue oxygen levels are <40 mmhg in atmospheric air but rise to >200 mmhg on 100% oxygen at pressure 2.2-2.5 ATA. 3.1.2.2 Osteoradionecrosis (ORN) of the Head and Neck All the following criteria apply: After assessment and discussion with the DDRC a relevant MDT believes: Page 8 of 17
(i) That there is a clear case for treatment; and (ii) There is a significant probability of successful treatment; and Reconstructive surgery will be performed, if appropriate, to remove any dead tissue. 3.1.2.3 Prevention of Osteo-radionecrosis, for Head and Neck Surgery All the following criteria apply: After assessment and discussion with the DDRC a relevant MDT believes that: (i) that there is a clear case for treatment; and (ii) there is a significant probability of a chronic nonhealing wound which will be successful prevented by HBOT; and The MDT confirm that there has been used a radiation dose of >45 Gy in the field of operation or where severe accidental overdosing with radiation has occurred. 3.1.2.4 Soft Tissue Radiation Tissue Damage Including Rectum, Intestine, Bladder and Laryngeal Irradiated Fields) Soft tissue radio necrosis of the CNS is not funded, as the evidence base for this is very poor. All the following criteria apply: After assessment and discussion with the DDRC a relevant MDT believes that: (i) There is a clear case for treatment; and (ii) There is a significant probability of successful treatment; and Where conservative treatment has not been successful failing to show healing tendency within 6 weeks; and Reconstructive surgery has been performed, if appropriate, to remove any dead tissue. 3.1.2.5 Chronic Refractory Osteomyelitis All the following criteria apply: After assessment and discussion with the DDRC a relevant MDT believes that: (i) There is a clear case for treatment; and Page 9 of 17
(ii) There is a significant probability of successful treatment; and Surgery to remove dead tissue has been or will be performed, if appropriate. HBO may be given perioperatively; and Where conservative treatment, including appropriate high dose antibiotics, has not been successful over a 6 weeks of intensive treatment. 3.2 Criteria for Treatment The main providers for emergency HBOT are the Diving Diseases Research Centre DDRC, with a local chamber in Cardiff, which supplies the South Wales population and the North West Emergency Recompression Unit in the Wirral which supplies the North Wales Population. All emergency indications must be clinically assessed by a physician qualifies in diving diseases and hyperbaric oxygen treatment 3.3 Referral Pathway Elective referrals can only be received directly from a relevant secondary care multi-disciplinary team (MDT) that has assessed the case, and after discussion with the DDRC believes that there is a clear case for treatment and a significant probability of successful treatment. Cases will be assessed by a doctor within DDRC before treatment is commenced. 3.3.1 Decompression Illness / Gas Embolism Referrals can be received directly from the Emergency services or the responsible clinician involved in the care of the patient. Cases will be assessed by a doctor within DDRC before treatment is commenced. Prior approval for treatment is not required. 3.3.2 Carbon Monoxide Intoxication Referrals can be received directly from the emergency services or the responsible clinician involved in the care of the patient. Cases will be assessed by a doctor within DDRC before treatment is commenced. Prior approval for treatment is not required. 3.3.3 Life Threatening Anaerobic or Mixed Soft Tissue Infections Referrals can only be received directly from a secondary care Consultant. Cases will be assessed by a doctor within DDRC before Page 10 of 17
treatment is commenced. Prior approval for treatment is not required. Treatment will only be given for severe or life threatening infections like gas gangrene or necrotising fasciitis and not for milder soft tissue infections. 3.3.4 Crush Injuries and Other Traumatic Ischemia With Compromised Circulation Referrals can only be received directly from a secondary care Consultant. Cases will be assessed by a doctor within DDRC before treatment is commenced. Prior approval for treatment is not required. 3.4 Exclusions Only those indications listed in 3.1 are funded. 3.5 Exceptions If the patient does not meet the criteria for treatment, but the referring clinician believes that there are exceptional grounds for treatment an Individual Patient Funding Request (IPFR) can be made to WHSS under the All Wales Policy for Making Decisions on Individual Patient Funding Requests (IPFR). If the patient wishes to be referred to a provider out of the agreed pathway, an IPFR should be submitted. Guidance on the IPFR process is available at www.whssc.wales.nhs.uk 3.6 Responsibilities Referrers should: Inform the patient that this treatment is not routinely funded outside the criteria in this policy; and Refer via the agreed pathway. Clinician considering treatment should: Discuss all the alternative treatment with the patient; Advise the patient of any side effect and risks of the potential treatment; Page 11 of 17
Inform the patient that treatment is not routinely funded outside of the criteria in the policy; and Confirm that there is contractual agreement with WHSSC for the treatment. In all other circumstances submit an IPFR. Page 12 of 17
4. Putting Things Right: Raising a Concern Whilst every effort has been made to ensure that decisions made under this policy are robust and appropriate for the patient group, it is acknowledged that there may be occasions when the patient or their representative are not happy with decisions made or the treatment provided. The patient or their representative should be guided by the clinician, or the member of NHS staff with whom the concern is raised, to the appropriate arrangements for management of their concern: When a patient or their representative is unhappy with the decision that the patient does not meet the criteria for treatment further information can be provided demonstrating exceptionality. The request will then be considered by the All Wales IPFR Panel. If the patient or their representative is not happy with the decision of the All Wales IPFR Panel the patient and/or their representative has a right to ask for this decision to be reviewed. The grounds for the review, which are detailed in the All Wales Policy: Making Decisions on Individual Patient Funding Requests (IPFR), must be clearly stated. The review should be undertaken, by the patient's Local Health Board; When a patient or their representative is unhappy with the care provided during the treatment or the clinical decision to withdraw treatment provided under this policy, the patient and/or their representative should be guided to the LHB for NHS Putting Things Right. For services provided outside NHS Wales the patient or their representative should be guided to the NHS Trust Concerns Procedure, with a copy of the concern being sent to WHSSC. Page 13 of 17
5. Equality Impact and Assessment The Equality Impact Assessment (EQIA) process has been developed to help promote fair and equal treatment in the delivery of health services. It aims to enable Welsh Health Specialised Services Committee to identify and eliminate detrimental treatment caused by the adverse impact of health service policies upon groups and individuals for reasons of race, gender re-assignment, disability, sex, sexual orientation, age, religion and belief, marriage and civil partnership, pregnancy and maternity and language (welsh). This policy has been subjected to an Equality Impact Assessment. The Assessment demonstrates that the policy is robust and that there is no potential for discrimination or adverse impact. All opportunities to promote equality have been taken. Page 14 of 17
Annex (i) Elective Referral Pathway Secondary care MDT HBOT centre (DDRC Cardiff and Plymouth; North West Emergency Recompression Unit, Wirral; or, for emergency treatment, nearest chamber) Page 15 of 17
Annex (ii) Checklist CP07 Hyperbaric Oxygen Therapy The following checklist should be completed and retained as evidence of policy compliance by the receiving centre. It is expected that this evidence will be provided at the point of invoicing by the receiving centre. i) Where the patient meets the criteria AND the procedure is included in the contract AND the referral is received by an agreed centre, the form should be completed and retained by the receiving centre for audit purposes. ii) The patient meets the criteria AND is received at an agreed centre, but the procedure is not included in the contract. The checklist must be completed and submitted to WHSSC for prior approval to treatment. iii) The patient meets the criteria but wishes to be referred to a non contracted provider. An Individual Patient Funding Request (IPFR) Form must be completed and submitted to WHSSC for consideration. iv) The patient does not meet criteria, but there is evidence of exceptionality. An Individual Patient Funding Request (IPFR) Form must be completed and submitted to WHSSC for consideration for treatment. Page 16 of 17
To be completed by the referring gatekeeper or treating clinician PRIOR APPROVAL Please tick the appropriate boxes: Patient NHS No: Patient is Welsh Resident Patient is English Resident Post Code: GP Code: Patient meets following access criteria for treatment: Emergency indications: a. Decompression illness / gas embolism b. Carbon monoxide intoxication c. Life threatening anaerobic or mixed soft tissue infections d. Crush injuries and other traumatic ischemia with compromised circulation Elective indications: Diabetic foot ulcers Osteoradionecrosis (ORN) of the head and neck prevention of osteo-radionecrosis for head and neck surgery soft tissue radiation tissue damage Chronic refractory osteomyelitis Patient wishes to be referred to non-contracted provider An Individual Patient Funding Request (IPFR) must be completed and submitted to WHSSC for approval prior to treatment. The form must clearly demonstrate why funding should be provided as an exception. The form can be found at http://www.wales.nhs.uk/sites3/docopen.cfm?orgid=898&id=181455 Patient does not meet access criteria but is exceptional An Individual Patient Funding Request (IPFR) must be completed and submitted to WHSSC for approval prior to treatment. The form must clearly demonstrate why funding should be provided as an exception. The form can be found at http://www.wales.nhs.uk/sites3/docopen.cfm?orgid=898&id=181455 Yes No Name: Designation: Signature: Date: Authorised by TRM Gatekeeper Authorised by Patient Care Team? Authorised by Other (Please state whom) Patient care Team/IPFR TRM Reference number: Name (printed): Signature: Date: Yes No Page 17 of 17