specialised services policy: cp35 cochlear implants...icd-10 h90.3 sensorineural hearing loss,...

CP35 Cochlear Implants Version: 4.0 of 21

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


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

of 7pmp

2.0

2.0 February

2013

Moved to new template with minor

changes

2.0 May 2014 Provided greater clarity on criteria for

bilateral and unilateral cochlear

implant and information on clinical

indications for assessment and clinical

criteria for treatment.

2.1

2.1 March 2013 Ratified through Chair’s Action on

behalf of Management Group

3.0

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


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


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;


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


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


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.


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


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

Category

Code Description

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

Category

Code Description

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 Description

CZ25Q Cochlear Implants without CC?


CZ26Z Bone Anchored Hearing Aids


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


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


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:

http://www.wales.nhs.uk/sites3/Documents/898/Item%208%20-%20IPFR%20Funding.pdf




http://www.whssc.wales.nhs.uk/


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.


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.


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.


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)


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.


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:

Name: __________________________ Designation: _______________

Signature: ______________________ Date: ____________________

Patient NHS No:

Patient is Welsh Resident Post

Code

Patient is English Resident registered with

NHS Wales GP

GP

Code:

Yes No

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

Name (printed):

Signature: Date: Yes No

Authorised by

TRM Gatekeeper

Authorised by

Patient Care

Team

Authorised by

Agreed other

(please state)

IPM/IPFR TRM Reference number:

http://www.wales.nhs.uk/sites3/docopen.cfm?orgid=898&id=181455


