Specialised Services Policy: CP35 Cochlear Implants Document Author: Specialised Planner for Women & Children s Services Executive Lead: Director of Planning Approved by: Executive Board Issue Date: 05 August 2014 Review Date: August 2017 Document No: CP35 Page 1 of 21
Document History Revision History Version No. Revision date Summary of Changes Updated to version no.: 0 27/03/2012 New Policy Developed & Published 1.0 1.0 May 2007 Include adult cochlear implants at rate 2.0 of 7pmp 2.0 February 2013 Moved to new template with minor changes 2.0 May 2014 Provided greater clarity on criteria for 2.1 bilateral and unilateral cochlear implant and information on clinical indications for assessment and clinical criteria for treatment. 2.1 March 2013 Ratified through Chair s Action on 3.0 behalf of Management Group 3.0 June 2014 Minor changes made to language 3.1 3.1 05/08/2014 Approved by Executive Board. Ratified through Chair s Action on behalf of Management Group 4.0 Date of next revision August 2017 Consultation Name Date of Issue Version Number South Wales Cochlear Implant Programme North Wales Cochlear Implant Programme Central Manchester NHS Foundation Trust South Wales Cochlear Implant Programme 8/6/2014 North Wales Cochlear Implant Programme 8/6/2014 South Wales Cochlear Implant Programme 7/7/2014 North Wales Cochlear Implant Programme 7/7/2014 Central Manchester NHS Foundation Trust 15/7/2014 Approvals Name Date of Issue Version No. HCW Clinical Policy Group Sept 2006 0.2 HCW Management Team/Director s Group Oct 2006 1.0 WHSSC Joint Committee March 2012 2.0 WHSSC Management Group (Chair s action) 05/03/13 3.0 WHSSC Management Group (Chair s action) 05/08/14 4.0 Distribution this document has been distributed to Name By Date of Issue Version No. Welsh Health Specialised Services Committee Website WHSSC Page 2 of 21
Page 3 of 21
Policy Statement Background The Welsh Health Specialised Services Committee is responsible for the commissioning of Cochlear Implant services including assessment, surgical implantation, rehabilitation and maintenance of implants. A cochlear implant is an implanted electronic hearing device designed to produce useful hearing sensations to a person with severe to profound nerve deafness by electrically stimulating nerves inside the inner ear. The implant consists of two main components: an externally worn microphone, sound processor and transmitter and the implanted receiver and electrode system which contains the electronic circuits that receive signals from the external system and send electrical currents to the inner ear. Summary of Access Criteria For the purpose of this policy, severe to profound deafness is defined as hearing only sounds that are 90 dbhl or greater at 2 khz and 4 khz. The clinical indications for assessment is where children or adults do not gain adequate benefit from acoustic hearing aids for at least 3 months (unless contraindicated or inappropriate). Children and adults should only be considered for cochlear implantation after an assessment by the Cochlear multidisciplinary team. Paediatric and adult cases are eligible for implantation as long as the following points are met: The patient meets all of the agreed audiological, physical and psychological criteria outlined in the relevant national Guidelines (e.g. BCIG and NICE); The patient should be fit for general anaesthesia; Parental and/or patient understanding of the expectations and agreement to the Page 4 of 21
long-term commitment of a cochlear implant. Unilateral cochlear implantation is recommended as an option for people with severe to profound deafness who do not receive adequate benefit from acoustic hearing aids. Adequate benefit is defined by national guidance and is reviewed on an annual basis with WHSSC through the All Wales Cochlear Audit Day. Simultaneous bilateral cochlear implantation is recommended as an option for the following groups of people with severe to profound deafness who do not receive adequate benefit from acoustic hearing aids (as defined above): Children Adults who are blind or who have other disabilities that increase their reliance on auditory stimuli as a primary sensory mechanism for spatial awareness Sequential cochlear implantation was recommended by the National Institute for Health and Clinical Excellence (NICE) in 2009 for children who had previously received unilateral cochlear implantation. Sequential cochlear implantation may also be used when there are complications during surgery for bilateral cochlear implantation or where patients are blind or who have other disabilities that increase their reliance on auditory stimuli as a primary sensory mechanism for spatial awareness. Responsibilities Referrers should: Inform the patient that this treatment is not routinely funded outside the criteria in this policy; Refer via the agreed pathway. Clinician considering treatment should: Discuss all the alternative treatment(s) with the patient; Advise the patient of any side effects and risks of the potential treatment; Page 5 of 21
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 request Page 6 of 21
Table of Contents 1. Aim... 8 1.1 Introduction... 8 1.2 Relationship with other Policies and Service Specifications... 8 2. Scope... 9 2.2 Codes... 10 3. Access Criteria... 12 3.1 Clinical Indications for assessment... 12 3.2 Criteria for Treatment... 12 3.4 Exclusions... 14 3.5 Exceptions... 14 3.6 Responsibilities... 14 4. Putting Things Right: Raising a Concern... 16 5. Equality Impact and Assessment... 17 Annex (i) Referral Pathway... 18 Annex (ii) Checklist... 19 Page 7 of 21
1. Aim 1.1 Introduction The document has been developed as the policy for the planning of Cochlear Implants 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 Cochlear Implants services; clarify the referral process; and define the criteria that patients must meet in order to be eligible for treatment. 1.2 Relationship with other Policies and Service Specifications This document should be read in conjunction with the following documents: Specialised Services Service Specification: Cochlear Implantation; All Wales Policy: Making Decisions on Individual Patient Funding Requests (IPFR); National Institute for Health and Clinical Excellence (2009) Cochlear Implants for children and adults with severe to profound deafness NICE technology appraisal guidance 166; British Cochlear Implant Group guidelines. Page 8 of 21
2. Scope 1. Purpose 2.1 Definition The Welsh Health Specialised Services Committee is responsible for the commissioning of Cochlear Implant services including assessment, surgical implantation, rehabilitation and maintenance of implants. A cochlear implant is an implanted electronic hearing device designed to produce useful hearing sensations to a person with severe to profound nerve deafness by bypassing the damaged hair cells in the inner ear and stimulating the hearing nerve directly. The implant consists of two main components: an externally worn microphone, sound processor and transmitter and the implanted receiver and electrode system which contains the electronic circuits that receive signals from the external system and sends electrical currents to the inner ear. Hearing loss may be caused by interference with the transmission of sound from the outer to the inner ear (conductive hearing loss) or damage within the cochlea, the auditory nerve or auditory centres in the brain (sensorineural hearing loss). Deafness is not typically associated with increased mortality, and need not be associated with significant morbidity. Some people who are deaf identify with a cultural model of deafness in which deafness is not considered an impairment. These people, who often use sign language and grow up as members of the Deaf community, may not perceive deafness to have a major impact on their quality of life. However for a child who is born deaf within a hearing family or for a person who becomes deaf and is used to functioning in an hearing environment deafness can have a significant impact on their quality of life. For children, deafness may have significant consequences for linguistic, cognitive, emotional, educational and social development. Loss of hearing affects an adult s ability to hear environmental noises and to understand speech; this can affect their ability to take part in their daily activities and be part of their usual social and professional networks, which can lead to isolation and mental health problems. There are services for people who are deaf which aim to improve their quality of life by maximising their ability to communicate, using the means most appropriate for the person and their Page 9 of 21
environment, and to enable the person to move safely within their environment. This includes using sign language and hearing aids. However for some people there are two few functioning hair cells for hearing aids to be of use. Cochlear implantation is therefore considered when there is no other suitable intervention. A Cochlear implant programme provides: Identification and assessment for suitability of patients for cochlear implant; Implantation of the cochlear implant; Post surgical management; Rehabilitation; Audiological/speech and language therapy; Regular maintenance and upgrades 2.2 Codes ICD-10 Codes Code Code Description Category ICD-10 H90.3 Sensorineural hearing loss, bilateral ICD-10 H90.6 Mixed conductive and sensorineural hearing loss, bilateral ICD-10 H90.5 Sensorineural hearing loss, bilateral (which includes congenital deafness) OPCS 4 Codes Code Code Description Category OPCS 4 D13 Attachment of Bone Anchored Hearing Prosthesis OPCS 4 D16 Reconstruction of Ossicular Chain OPCS 4 D24 Operation on Cochlea OPCS 4 D241 Implantation of intracochlear prosthesis OPCS 4 D242 Implantation of extra cochlear prosthesis OPCS 4 D243 Attention to cochlear prosthesis OPCS 4 D246 Removal of cochlear prosthesis HRG Codes Code Category Code CZ25Q Description Cochlear Implants without CC? Page 10 of 21
CZ26Z Bone Anchored Hearing Aids Page 11 of 21
3. Access Criteria 3.1 Clinical Indications for assessment For the purpose of this policy, severe to profound deafness is defined as hearing only sounds that are 90 dbhl or greater at 2 khz and 4 khz. The clinical indications for assessment is where children or adults do not gain adequate benefit from acoustic hearing aids for at least 3 months (unless contraindicated or inappropriate). Children and adults should only be considered for cochlear implantation after an assessment by the Cochlear multidisciplinary team. 3.2 Criteria for Treatment Paediatric and adult cases are eligible for implantation as long as the following points are met: The patient meets all of the agreed audiological, physical and psychological criteria outlined in the relevant national Guidelines (e.g. BCIG and NICE); The patient should be fit for general anaesthesia; Parental and/or patient understanding of the expectations and agreement to the long-term commitment of a cochlear implant. The following describes the different clinical indications for each form of cochlear implantation. 3.2.1 Unilateral cochlear implantation Unilateral cochlear implantation is recommended as an option for people with severe to profound deafness who do not receive adequate benefit from acoustic hearing aids. Adequate benefit is defined by national guidance and is reviewed on an annual basis with WHSSC through the All Wales Cochlear Audit Day. 3.2.2 Simultaneous bilateral cochlear implantation Simultaneous bilateral cochlear implantation is recommended as an option for the following groups of people with severe to profound Page 12 of 21
deafness who do not receive adequate benefit from acoustic hearing aids (as defined above): Children Adults who are blind or who have other disabilities that increase their reliance on auditory stimuli as a primary sensory mechanism for spatial awareness 3.2.3 Sequential bilateral cochlear implantation Sequential cochlear implantation was recommended by the National Institute for Health and Clinical Excellence (NICE) in 2009 for children who had previously received unilateral cochlear implantation. Sequential cochlear implantation may also be used when there are complications during surgery for bilateral cochlear implantation or where patients are blind or who have other disabilities that increase their reliance on auditory stimuli as a primary sensory mechanism for spatial awareness. 3.3 Referral Pathway Potential candidates for cochlear implants are referred to one of the cochlear implant centres in England and Wales where contracts are in place with the Welsh Health Specialised Services Committee. Patients will receive a multidisciplinary assessment to determine whether they are suitable for cochlear implantation. Both audiological hearing and functional hearing are assessed as part of the multidisciplinary assessment, as well as other factors such as fitness for surgery, structure of the cochlea, the presence of a functioning auditory nerve and the likely ability of the person to derive benefit from the stimuli produced by the cochlear implant system. As part of the assessment children and adults should also have had a valid trial of an acoustic hearing aid for at least 3 months (unless contraindicated or inappropriate). Referrals are to be made by either a GP; an ENT specialist, Audiovestibular Physician or an Audiologist to the centres below where contracts are in place with the Welsh Health Specialised Services Committee. Population referral routes are confirmed below: North Wales Page 13 of 21
Adult referrals should be made to the North Wales Cochlear Implant Programme in Betsi Cadwaladr University Health Board (Glan Clwyd Hospital). Paediatric cases should be referred to Manchester Cochlear Implant Programme at Central Manchester University Hospitals NHS Foundation Trust. Mid & West and South Wales Referrals should be made to the South Wales Cochlear Implant Programme based in both Abertawe Bro Morgannwg Univerity Health Board and Cardiff and Vale University Health Board. The service is led by Cardiff and Vale University Local Health. A Referral Pathway flow diagram is included as Annex (i). 3.4 Exclusions There are no exclusion criteria. Patients who meet the access criteria will be assessed by either Cochlear Implant Programme for cochlear implantation. 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 WHSSC under the All Wales Policy for Making Decisions on Individual Patient Funding Requests (IPFR). Form should be included in appendix? If the patient wishes to be referred to a provider out of the agreed pathway and the referring clinician believes that there are exceptional grounds for treatment at an alternative provider, an Individual Patient Funding Request (IPFR) can be made to WHSSC under the All Wales Policy for Making Decisions on Individual Patient Funding Requests (IPFR). Guidance on the IPFR process is available at www.whssc.wales.nhs.uk 3.6 Responsibilities Referrers should: Page 14 of 21
Inform the patient that this treatment is not routinely funded outside the criteria in this policy; and Refer via the agreed pathway and provide a written referral with supporting audiological information. Clinicians considering treatment should: Discuss all the alternative treatments with the patient; Advise the patient of any side effect and risks of the potential treatment; Confirm that there is contractual agreement with WHSSC for the treatment; and Inform the patient that treatment is not routinely funded outside of the criteria in the policy; In all other circumstances submit an IPFR request. Page 15 of 21
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, of the gatekeeper, 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 Request (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 16 of 21
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 the policy is robust and there is no potential for discrimination or adverse impact. All opportunities to promote equality have been taken. Page 17 of 21
Annex (i) Referral Pathway GP, Secondary Care ENT Specialist or Audiologist South Wales Cochlear Implant Service (Cardiff and Vale LHB & Abertawe Bro Morgannwg University LHB) (Contract in place) North Wales Adults to Cochlear Implant Programme (Betsi Cadwaladwr University LHB) (Contract in place) Paediatrics cases should be referred to Manchester Cochlear Implant Programme, Central Manchester University Hospitals NHS Foundation Trust (to be agreed via IPFR process) Page 18 of 21
Annex (ii) Checklist CP35 Cochlear Implants The following checklist overleaf 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. This needs rewording 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 19 of 21
To be completed by the referring gatekeeper or treating clinician The following checklist should be completed for all patients to whom the policy applies, before treatment, by the responsible clinician. Please complete the appropriate boxes: Patient NHS No: Patient is Welsh Resident Patient is English Resident registered with NHS Wales GP Post Code GP Code: Patient meets following access criteria for treatment: Severe to profound hearing loss bilaterally averaging > 90dBHL at 2 & 4 KHz The patient meets all of the agreed audiological, physical and psychological criteria outlined in the relevant national Guidelines (e.g. BCIG and NICE) Patient should be fit for anaesthesia and surgery Patient must have an understanding of the expectations and agreement to the long term commitment Patient wishes to be referred to non-contracted provider If the patient wishes to be referred to a 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 on the basis of exceptionality. The form can be found at http://www.wales.nhs.uk/sites3/docopen.cfm?orgid=898&i d=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&i d=181455 Yes No Name: Designation: Signature: Date: Authorised by TRM Gatekeeper Authorised by Patient Care Team Authorised by Agreed other (please state) IPM/IPFR TRM Reference number: Name (printed): Signature: Date: Yes No Page 20 of 21
Page 21 of 21