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NHS BOLTON CLINICAL COMMISSIONING GROUP Public Board Meeting AGENDA ITEM NO: ……8……………… Date of Meeting: ……13th November 2020………… TITLE OF REPORT:

GM Policies for Approval

AUTHOR:

GMSS Effective Use of Resources Team/ Michael Robinson, Associate Director Integrated Governance & Policy

PRESENTED BY:

Jane Bradford, Clinical Director, Governance & Safety

PURPOSE OF PAPER: (Linking to Strategic Objectives)

The paper updates the Board on 2 new GM Policies which have been through the agreed GM Effective Use of Resources governance arrangements and approved by GM Directors of Commissioning: Cough Assist. Non Specialist and Augmentative & Alternative

Communication Aids.

LINKS TO CORPORATE OBJECTIVES (tick relevant boxes):

Deliver the outcomes in the Bolton Joint Health and Care Plan.

Ensure compliance with the NHS statutory duties and NHS Constitution.

Deliver financial balance. Regulatory Requirement. √ Standing Item.

RECOMMENDATION TO THE BOARD: (Please be clear if decision required, or for noting)

The Board is asked to approve the policies which will be varied in to our contract with providers and disseminated throughout primary care thereafter.

COMMITTEES/GROUPS PREVIOUSLY CONSULTED:

Greater Manchester Effective Use of Resources Steering Group and associated clinical consultation. Greater Manchester Directors of Commissioning. CCG Executive.

REVIEW OF CONFLICTS OF INTEREST:

Conflicts of Interest are reviewed through the GM governance and consultation processes.

VIEW OF THE PATIENTS, CARERS OR THE PUBLIC, AND THE EXTENT OF THEIR INVOLVEMENT:

Full clinical consultation undertaken as part of this review process.

OUTCOME OF EQUALITY IMPACT ASSESSMENT (EIA) AND ANY ASSOCIATED RISKS:

EIA and an assessment undertaken as part of the GM policy development process.

Greater Manchester EUR Policy Statement on:

Cough Assist (Mechanical

Insufflation and Exsufflation (MI-E)) GM Ref: GM073 Version: 0.4 (17 February 2020)

DRAFT Policy is currently awaiting governance approval to

implement

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Commissioning Statement

Cough Assist (Mechanical Insufflation and Exsufflation (MI-E)

Policy Exclusions (Alternative commissioning arrangements apply)

Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect). NHSE Commissioned services are excluded from this policy

Policy Inclusion Criteria

Cough Assist is commissioned for patients with weak cough which increases the risk of chest infection as a result of an underlying condition including, but not restricted to, the following:

Neuromuscular diseases such as Amyotrophic lateral sclerosis (ALS); Spinal muscular atrophy; Muscular dystrophy; Myasthenia gravis; multiple sclerosis

Guillain-Barré Syndrome

Post polio syndromes

Kypho-scoliosis

Syringomyelia

Spinal cord injuries

Patients should also have one of the following:

PCF (Peak Cough Flow) less than 160 L/min OR

PCF (Peak Cough Flow) of < 270 l/pm and have clinical symptoms / weak cough requiring an intervention in order to clear bronchial secretions or infection. (PCF can be measured by coughing into a peak flow meter attached to a mask MI-E Guidelines 2013 3) OR

VC (vital capacity) below 1.1L in general respiratory muscle weakness.

Requests for Mechanical Insufflation and Exsufflation (MI-E) or 'cough assist therapy' for patients who do not meet the above criteria are considered low priority and will not be routinely funded.

For individuals who cannot undergo Peak Cough Flow testing the following criteria should be used instead:

Recurrent hospital admissions, OR

Effective use of equipment during inpatient admission, OR

2 courses of antibiotics prescribed for chest infections over 6 month period,

OR

evidence of retained secretions on auscultation with an inability to clear these

Funding Mechanism: Monitored Approval (MA) provided the patient meets the above criteria.

Cough Assist is not routinely commissioned for patients with:- Absolute contraindications

When the patient has haemoptysis, untreated or recent pneumothorax, bullous emphysema, nausea and emesis, severe COPD, severe asthma or has had a recent lobectomy

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When the patient has Increased intra cranial pressure (ICP) including when managed by ventricular drains

When the patient has impaired consciousness or an inability to communicate in instances where the patient does NOT have an artificial airway (unless supported by the specialist team)

Relative contraindications

if the patient has tachypnea

there is a history of COPD and pneumothorax

in the presence of large pleural effusion

when the presence of a cervical spinal injury is unclear

where there is hemodynamic instability

where there is an inability to communicate where the patient has an artificial airway

Supplemental oxygen should not be bled into the MI-E circuit unless the device is designed specifically designed to allow this. Oxygen passing through the fan system during the exsufflation phase could result in a potential fire hazard.

Funding Mechanism: Individual funding request (exceptional case) approval: Requests must be submitted with all relevant supporting evidence in the first instance.

(Note: These must come from a Secondary/Tertiary Care Clinician)

Clinical Exceptionality

Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

Best Practice Guidelines

All providers are expected to follow best practice guidelines (where available) in the management of these conditions.

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Contents Commissioning Statement ........................................................................................................................ 2

Policy Statement ...................................................................................................................................... 5

Equality & Equity Statement ..................................................................................................................... 5

Governance Arrangements ....................................................................................................................... 5

Aims and Objectives ................................................................................................................................. 5

Rationale behind the policy statement ...................................................................................................... 6

Treatment / Procedure .............................................................................................................................. 6

Epidemiology and Need ........................................................................................................................... 7

Adherence to NICE Guidance .................................................................................................................. 7

Audit Requirements .................................................................................................................................. 7

Date of Review ......................................................................................................................................... 7

Glossary ................................................................................................................................................... 7

References ............................................................................................................................................... 8

Governance Approvals ............................................................................................................................. 9

Appendix 1 – Evidence Review .............................................................................................................. 10

Appendix 2 – Diagnostic and Procedure Codes ...................................................................................... 12

Appendix 3 – Version History ................................................................................................................. 14

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Policy Statement The GM Effective Use of Resources (EUR) Policy Team, in conjunction with the GM EUR Steering Group, have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document. In creating this policy the GM EUR Steering Group has reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester. This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR).

Equality & Equity Statement CCGs have a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012. CCGs are committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, CCGs will have due regard to the different needs of protected characteristic groups, in line with the Equality Act 2010. This document is compliant with the NHS Constitution and the Human Rights Act 1998. This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GM EUR Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their ‘starting point’ is considered to be further back than any other group. This will be reflected in CCGs evidencing taking ‘due regard’ for fair access to healthcare information, services and premises. An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact policyfeedback.gmcsu@nhs.net.

Governance Arrangements The Greater Manchester Joint Commissioning Board has given delegated authority to the Greater Manchester Directors of Commissioning and Directors of Finance to approve GM EUR treatment policies for implementation. Further details of the governance arrangements can be found in the GM EUR Operational Policy.

Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by:

reducing the variation in access to treatments/procedures.

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ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness.

reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester.

promoting the cost-effective use of healthcare resources.

Rationale behind the policy statement There have been a number of Individual Funding Requests (IFRs) received by the GM EUR Team for cough assist machines. As these can be cost effective by reducing acute admissions for respiratory infection in the target group of patients this policy has been developed to ensure consistency in decision making.

Treatment / Procedure The mechanical insufflator/exsufflator (MI-E) assists the clearance of bronchopulmonary secretions in those patients with an ineffective cough by the use of both positive and negative pressure.

Cough Assist is a non-invasive therapy that safely and consistently removes secretions in patients with an ineffective ability to cough (peak cough flow <270 l/m). The Cough Assist device clears secretions by gradually applying a positive pressure to the airway, then rapidly shifting to negative pressure. The rapid shift in pressure produces a high expiratory flow, simulating a natural cough.

It can be used with a face mask, mouthpiece or with an adapter to a patient's endotracheal or tracheostomy tube. It is approved for home use in adults and children and is available in automatic and manual models.

Benefits Removes secretions from the lungs

Reduces the occurrence of respiratory infections

Safe, non-invasive alternative to suctioning in some patients

Easy for patients and caregivers to operate

Indications for Use Typical Cough Assist patients include those with the following conditions:

Amyotrophic lateral sclerosis

Spinal muscular atrophy

Muscular dystrophy

Myasthenia gravis

Spinal cord injuries

Reduced Peak Cough Flow (PCF) of 160l/pm or 270 l/pm or < 270 l/pm and have clinical symptoms or a weak cough and therefor require intervention necessary to clear bronchial secretions or infection

PCF can be measured by coughing into a peak flow meter attached to a mask MI-E Guidelines 2013 3

Contraindications

Any patient with a history of bullous emphysema

Susceptibility to pneumothorax or pnuemo-mediastinum

Recent barotrauma, should be carefully considered before use

The above contraindications should be carefully considered before use.

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Epidemiology and Need As this device can be used for a number of indications exact epidemiology is not available but the device is targeted at those within each indication for whom the alternative would be hospital admission.

Adherence to NICE Guidance None available

Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request.

Date of Review One year from the date of approval by the governance process and thereafter at a date agreed by the Greater Manchester EUR Steering Group, unless new evidence or technology is available sooner. The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review.

Glossary

Term Meaning

Asthma A respiratory condition marked by attacks of (reversible) spasm in the bronchi of the lungs, causing difficulty in breathing. It is usually connected to allergic reaction or other forms of hypersensitivity.

Bullous Emphysema The presence of one or several abnormally large air spaces surrounded by relatively normal lung tissue.

Chronic Obstructive Pulmonary Disease (COPD)

Is a lung disease characterized by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible. The more familiar terms 'chronic bronchitis' and 'emphysema' are no longer used, but are now included within the COPD diagnosis.

Emesis The action or process of vomiting.

Guillain-Barré Syndrome

A very rare and serious condition that affects the nerves. It mainly affects the feet, hands and limbs, causing problems such as numbness, weakness and pain. It can be treated and most people will eventually make a full recovery, although it can occasionally be life-threatening and some people are left with long-term problems. Guillain-Barré syndrome affects people of all ages, but your chances of getting it increase as you get older.

Hemodynamic Instability Where there are serious problems with the blood circulatory system.

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Haemoptysis The coughing up of blood.

Intra-Cranial Pressure The pressure inside the skull and thus in the brain tissue and cerebrospinal fluid (CSF). ICP is measured in millimeters of mercury (mmHg) and, at rest, is normally 7–15 mmHg for a supine adult.

Kypho-Scoliosis

A deformity of the spine characterized by abnormal curvature of the vertebral column in two planes (coronal and sagittal). It is a combination of kyphosis and scoliosis.

Lobectomy Surgical removal of a lobe of an organ (in the case of this policy – the lung)

Neuromuscular Diseases

The term that encompasses many diseases and ailments that impair the functioning of the muscles, either directly, being pathologies of the voluntary muscle, or indirectly, being pathologies of nerves or neuromuscular junctions

Peak Cough Flow The maximum air flow generated during a cough. It is used to assess cough in patients with respiratory muscle weakness, mainly in patients with neuromuscular pathology

Pleural Effusion Sometimes referred to as “water on the lungs,” is the build-up of excess fluid between the layers of the pleura outside the lungs. The pleura are thin membranes that line the lungs and the inside of the chest cavity and act to lubricate and facilitate breathing

Pneumothorax The presence of air or gas in the cavity between the lungs and the chest wall, causing collapse of the lung.

Post-Polio Syndrome

A condition that affects polio survivors years after recovery from an initial acute attack of the poliomyelitis virus. Most often, polio survivors start to experience gradual new weakening in muscles that were previously affected by the polio infection.

Syringomyelia

A chronic progressive disease in which longitudinal cavities form in the cervical region of the spinal cord. This characteristically results in wasting of the muscles in the hands and a loss of sensation.

Tachypnea Abnormally rapid breathing

Ventricular Drains A device used in neurosurgery to treat hydrocephalus and relieve elevated intracranial pressure when the normal flow of cerebrospinal fluid (CSF) inside the brain is obstructed.

Vital Capacity The maximum amount of air a person can expel from the lungs after a maximum inhalation. It is equal to the sum of inspiratory reserve volume, tidal volume, and expiratory reserve volume. A person's vital capacity can be measured by a wet or regular spirometer.

References 1. GM EUR Operational Policy 2. Walsall Clinical Commissioning Group - Commissioning Policy for Cough Assist Requests

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Governance Approvals

Name Date Approved

Greater Manchester Effective Use of Resources Steering Group 20/11/2019

Greater Manchester Directors of Commissioning / Greater Manchester Chief Finance Officers (Delegated authority given to approve policy by Greater Manchester Joint

Commissioning Board).

Bolton Clinical Commissioning Group

Bury Clinical Commissioning Group

Heywood, Middleton & Rochdale Clinical Commissioning Group

Manchester Clinical Commissioning Group

Oldham Clinical Commissioning Group

Salford Clinical Commissioning Group

Stockport Clinical Commissioning Group

Tameside & Glossop Clinical Commissioning Group

Trafford Clinical Commissioning Group

Wigan Borough Clinical Commissioning Group

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Appendix 1 – Evidence Review Cough Assist (Mechanical Insufflation and Exsufflation (MI-E)

GM073

Search Strategy The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; and the relevant Royal College and any other relevant bespoke sites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below:

Database Result

NICE Evidence BTS/ICS guideline for the ventilatory management of acute hypercapnic respiratory failure in adult.s. Davidson AC, et al. Thorax 2016;71:ii1–ii35. doi:10.1136/thoraxjnl-2015-208209

Summary of the evidence There is limited high level evidence as the studies required to achieve that would be unethical. However there is evidence that cough assist does reduce acute admissions and it has the backing of the British Thoracic society.

The evidence

Levels of evidence

Level 1 Meta-analyses, systematic reviews of randomised controlled trials

Level 2 Randomised controlled trials

Level 3 Case-control or cohort studies

Level 4 Non-analytic studies e.g. case reports, case series

Level 5 Expert opinion

1. LEVEL N/A - Specialist Guidelines based on Professional opinion and some studies BTS/ICS guideline for the ventilatory management of acute hypercapnic respiratory failure in adults. Davidson AC, et al. Thorax 2016;71:ii1–ii35. doi:10.1136/thoraxjnl-2015-208209 Extract from the relevant section: Sputum retention Recommendations 10. In patients with neuromuscular disease (NMD), mechanical insufflation and exsufflation should be used, in addition to standard physiotherapy techniques, when cough is ineffective and there is sputum retention (Grade B). 11. Mini-tracheostomy may have a role in aiding secretion clearance in cases of weak cough (NMD/chest wall disease (CWD)) or excessive amounts (COPD, cystic fibrosis (CF)) (Grade D).

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Added following clinical feedback:

2. LEVEL N/A - Specialist Guidelines based on Professional opinion and some studies British Thoracic Society guideline for respiratory management of children with neuromuscular weakness. Thorax 2012;67(Suppl 1):1–40 Richard S. Finkel, et al., Extract: Airway clearance and respiratory muscle training <Children with ineffective cough (including children over 12 years of age with cough peak flow <270 litres/min), particularly if they have had episodes of deterioration with respiratory infection, should be taught augmented cough techniques

Manual cough assist and air-stacking methods to achieve maximum insufflation capacity are effective methods of improving cough efficiency and should be used when appropriate

Mechanical insufflation/exsufflation (MI-E) should be considered in very weak children, those with loss of bulbar function, and those who cannot cooperate with manual cough assist or air-stacking or in whom these methods are not effective

Oscillatory techniques such as high-frequency chest wall oscillation and intrapulmonary percussive ventilation should be considered in children who have difficulty mobilising secretions or who have persistent atelectasis, despite use of other airway clearance techniques

Airway clearance techniques should be used during respiratory infection when oxygen saturation levels fall below 95% while the child is breathing room air. If the techniques being used fail to result in an increase in oxygen saturation to 95% or above, different methods of airway clearance should be used. This may require attendance at hospital for treatment.

MI-E should be available in the acute setting in all hospitals that treat neuromuscular patients as an alternative method of airway clearance with the purpose of preventing deterioration and the need for intubation and mechanical ventilation.

Nebulised normal saline may be considered in children who have continued tenacious secretions.

Humidification should be considered in children who use non-invasive ventilation (NIV) and who have tenacious airway secretions. Care should be taken to ensure that use of humidification does not result in a troublesome increase in oral secretions.

When using sputum mobilising techniques, appropriate emergency equipment (eg, resuscitation bag and suction) should be available in case of mobilising large mucus plugs into the central airways where they may result in airways obstruction.

Children who use regular night-time or diurnal NIV should use their ventilator to support deep breathing during airway clearance treatments. Use of NIV during airway clearance sessions can help prevent respiratory muscle fatigue.

Children who use MI-E for airway clearance should be given long enough periods of rest during treatment sessions to prevent respiratory muscle fatigue due to coughing.

At the end of a treatment session with MI-E it is important to complete the session with an insufflation to leave the child with an appropriate functional residual capacity.

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Appendix 2 – Diagnostic and Procedure Codes Cough Assist (Mechanical Insufflation and Exsufflation (MI-E)

GM073

(All codes have been verified by Mersey Internal Audit’s Clinical Coding Academy)

GM073 – Cough Assist (Mechanical Insufflation and Exsufflation (MI-E)

OPCS-4 Procedure Codes

Other specified ventilation support - Note: this is the closest code for this procedure, although might not be currently coded at all)

E895

Mechanical insufflation and exsufflation (code expected to be implemented on 1 April

2020)

With the following ICD-10 diagnosis code(s):

Motor neuron disease G122

Spinal muscular atrophy, unspecified G129

Muscular dystrophy G710

Myotonic disorders G711

Congenital myopathies G712

Hereditary motor and sensory neuropathy G600

Myasthenia gravis G700

Transient neonatal myasthenia gravis P940

Multiple sclerosis G35X

Guillain-Barré syndrome G610

Postpolio syndrome G14X

Scoliosis, unspecified M419

Congenital deformity of spine Q675

Syringomyelia and syringobulbia G950

Sequelae of injury of spinal cord T913

ICD-10 codes (Exceptions)

Haemoptysis R042

Unspecified pulmonary haemorrhage originating in the perinatal period P269

Spontaneous tension pneumothorax J930

Other spontaneous pneumothorax J931

Other pneumothorax J938

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Other pneumothorax J939

Pneumothorax originating in the perinatal period P251

Emphysema, unspecified J439

Nausea and vomiting R11X

Other specified chronic obstructive pulmonary disease J448

Chronic obstructive pulmonary disease, unspecified J449

Predominantly allergic asthma J450

Nonallergic asthma J451

Mixed asthma J458

Asthma, unspecified J459

Acquired absence of lung [part of] Z902

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Appendix 3 – Version History Cough Assist (Mechanical Insufflation and Exsufflation (MI-E)

GM073

Version Date Summary of Changes

0.1 02/07/2019 Initial draft

0.2 17/07/2019 01/08/2019

GM EUR Steering Group reviewed the initial draft policy and requested the following change:- Funding Mechanism for relative contraindications be changed from Individual Prior Approval (IPA) to Individual Funding Request (IFR) exceptional case. Subject to the above change being made the policy was approved to go out for a period of clinical engagement. Clinical Exceptionality Section updated to read: Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

0.3 20/11/2019 The GM EUR Steering Group reviewed the feedback received during the period of clinical engagement and agreed the following changes:- Name of policy amended to include ‘Mechanical Insufflation and Exsufflation (MI-E)’ in the title. Policy Exclusions – Added ‘NHSE Commissioned services are excluded from this policy’ Policy Inclusion Criteria – First paragraph reworded from: Cough Assist is commissioned for patients with the following (or similar) conditions: To: Cough Assist is commissioned for patients with weak cough which increases the risk of chest infection as a result of an underlying condition including, but not restricted to, the following: (MI-E) now written out in full - Mechanical Insufflation and Exsufflation The following paragraph added: For individuals who cannot undergo Peak Cough Flow testing the following criteria should be used instead:

Recurrent hospital admissions, OR

Effective use of equipment during inpatient admission, OR

2 courses of antibiotics prescribed for chest infections over 6 month

period, OR

evidence of retained secretions on auscultation with an inability to clear

these

The following words added to the end of the final bullet point of Absolute Contraindications ‘(unless supported by the specialist team)’ The following bullet point removed from the Relative contraindications

therapy immediately following meals

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The final paragraph under Relative contraindication amended from: Supplemental oxygen should not be bled into the MI-E circuit. Oxygen passing through the fan system during the exsufflation phase results in a potential fire hazard.

To: Supplemental oxygen should not be bled into the MI-E circuit unless the device is designed specifically designed to allow this. Oxygen passing through the fan system during the exsufflation phase could result in a potential fire hazard.

Treatment /Procedure - Benefits – ‘in some patients’ added following Safe, non-invasive alternative to suctioning

Evidence Review (Appendix 1) – Added an extract from the British Thoracic Society guideline for respiratory management of children with neuromuscular weakness. Thorax 2012;67(Suppl 1):1–40 Richard S. Finkel, et al., has been Following the above changes the GM EUR Steering Group approved the policy to progress through the governance process.

0.4 17/02/2020 Diagnostic and Procedure Codes added to Appendix 2

Greater Manchester EUR Policy Statement on:

Non-Specialist Augmentative and Alternative Communication (AAC) Aids GM Ref: GM057 Version: 0.4 (20 November 2019)

DRAFT Policy is currently awaiting governance approval to

implement

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Commissioning Statement

Non-Specialist Augmentative and Alternative Communication (AAC) Aids

Policy Exclusions (Alternative commissioning arrangements apply)

AAC aids for patients with complex needs are commissioned by NHS England and are excluded from this policy. AAC aids provided as part of an externally funded trial or as a part of locally commissioned service are excluded from this policy. Locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect). For more information see: https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2016/03/guid-comms-aac.pdf

Policy Inclusion Criteria

Devices not covered by the above arrangements are commissioned when:

They meet the definition of a locally commissioned device and are not commissioned elsewhere.

AND

The request has come from or has the support of a locally commissioned service.

Applications should include costs (giving three quotes or stating why less than three are available) If further information or advice is needed please email the following address: areeves@acecentre.org.uk

The device once funding is approved will be considered to be the property of the individual and they (the individual) are responsible for any insurance / maintenance arrangements. Replacement devices and / or replacement software will be considered in the same way as new requests and the same funding mechanism will apply

Funding Mechanism

Individual prior approval at triage (up to a value of £1,000) provided the patient meets the above criteria. Requests must be submitted with all relevant supporting evidence including three quotes for the device and software.

Clinicians can submit an individual funding request outside of this guidance if they feel there is a good case for clinical exceptionality. Requests must be submitted with all relevant supporting evidence.

Clinical Exceptionality

Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

Best Practice Guidelines

All providers are expected to follow best practice guidelines (where available) in the management of these conditions.

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Contents Commissioning Statement ........................................................................................................................ 2

Policy Statement ...................................................................................................................................... 4

Equality & Equity Statement ..................................................................................................................... 4

Governance Arrangements ....................................................................................................................... 4

Aims and Objectives ................................................................................................................................. 4

Rationale behind the policy statement ...................................................................................................... 5

Treatment / Procedure .............................................................................................................................. 5

Epidemiology and Need ........................................................................................................................... 5

Adherence to NICE Guidance .................................................................................................................. 5

Audit Requirements .................................................................................................................................. 5

Date of Review ......................................................................................................................................... 5

Glossary ................................................................................................................................................... 6

References ............................................................................................................................................... 6

Governance Approvals ............................................................................................................................. 6

Appendix 1 – Version History ................................................................................................................... 8

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Policy Statement The GM Effective Use of Resources (EUR) Policy Team, in conjunction with the GM EUR Steering Group, have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document. In creating this policy the GM EUR Steering Group has reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester. This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR).

Equality & Equity Statement CCGs have a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012. CCGs are committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, CCGs will have due regard to the different needs of protected characteristic groups, in line with the Equality Act 2010. This document is compliant with the NHS Constitution and the Human Rights Act 1998. This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GM EUR Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their ‘starting point’ is considered to be further back than any other group. This will be reflected in CCGs evidencing taking ‘due regard’ for fair access to healthcare information, services and premises. An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact policyfeedback.gmcsu@nhs.net.

Governance Arrangements The Greater Manchester Joint Commissioning Board has given delegated authority to the Greater Manchester Directors of Commissioning and Directors of Finance to approve GM EUR treatment policies for implementation. Further details of the governance arrangements can be found in the GM EUR Operational Policy.

Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of non-specialist Augmentative and Alternative Communication (AAC) Aids by CCGs in Greater Manchester by:

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reducing the variation in access to non-specialist Augmentative and Alternative Communication (AAC) Aids.

ensuring that non specialist Augmentative and Alternative Communication (AAC) Aids are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness.

reducing unacceptable variation in the commissioning non specialist Augmentative and Alternative Communication (AAC) Aids across Greater Manchester.

promoting the cost-effective use of healthcare resources.

Rationale behind the policy statement Requests have been received for non-specialist Augmentative and Alternative Communication (AAC) Aids where the patient does not meet the complexity of need required for an NHS England commissioned device and the ideal device is not routinely available via the local service(s). There is no evidence review for this policy as it is designed to close a funding gap and ensure equity of access to this equipment and to ensure consistency in decision making.

Treatment / Procedure Non-specialised devices including those devices that require message formulation by spelling and through direct access with the device. They are main stream and may be used for a limited range of communication production. Simple or text-based devices are often termed ‘lite tech’ and generally include some or all of the following features:

they are used to produce a relatively small number of utterances

are used to produce only single-concept utterances

have overlays or physical interfaces

are battery powered

use recorded speech

Epidemiology and Need Exact needs are not quantifiable as AAC services are not accessed by any single patient group. They are needed by individuals of all ages who may find communication difficult for a number of reasons. Those using AAC services include but is not limited to people with congenital disabilities (such as cerebral palsy, learning disability or autism); progressively disabling conditions (such as Motor Neurone Disease); or suddenly acquired disabilities (through stroke or brain damage following an injury).

Adherence to NICE Guidance None but there is NHS guidance on the provision of a local service – this policy is based on that guidance

Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request.

Date of Review One year from the date of approval by the governance process and thereafter at a date agreed by the Greater Manchester EUR Steering Group, unless new evidence or technology is available sooner.

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The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review.

Glossary

Term Meaning

Augmentative and Alternative Communication (ACC) Aids

Any device from the simple to the complex that enables people to talk to family and carers. Is an umbrella term that encompasses the communication methods used to supplement or replace speech or writing for those with impairments in the production or comprehension of spoken or written language.

Utterance A spoken word, statement, or vocal sound. The action of saying or expressing something aloud.

Congenital disabilities Functional difficulty caused by any abnormality that was present at birth.

Learning disability A disability that affects the way a person learns new things throughout their lifetime.

Autism or autism spectrum disorder (ASD)

A broad range of conditions characterised by challenges with social skills, repetitive behaviours, speech and nonverbal communication.

Progressive illness or disease A disease which despite treatment will worsen, or spread e.g Motor Neurone Disease.

Acquired disabilities A functional difficulty caused by any abnormality developed during the person’s lifetime that is a result of an accident or illness rather than occurring at birth.

Physical interfaces An interface is a shared boundary or connection between two dissimilar objects, devices or systems through which information is passed. A user interface (physical interface) is a linkage between a human and a computer.

References

1. GM EUR Operational Policy 2. Guidance for commissioning AAC services and equipment NHS England/Specialised Commissioning

published 04 March 2016 https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2016/03/guid-comms-aac.pdf

Governance Approvals

Name Date Approved

Greater Manchester Effective Use of Resources Steering Group 20/11/2019

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Greater Manchester Directors of Commissioning / Greater Manchester Chief Finance Officers (Delegated authority given to approve policy by Greater Manchester Joint

Commissioning Board).

Greater Manchester Joint Commissioning Board

Bolton Clinical Commissioning Group

Bury Clinical Commissioning Group

Heywood, Middleton & Rochdale Clinical Commissioning Group

Manchester Clinical Commissioning Group

Oldham Clinical Commissioning Group

Salford Clinical Commissioning Group

Stockport Clinical Commissioning Group

Tameside & Glossop Clinical Commissioning Group

Trafford Clinical Commissioning Group

Wigan Borough Clinical Commissioning Group

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Appendix 1 – Version History

Non-Specialist Augmentative and Alternative Communication (ACC) Aids GM057

Version Date Summary of Changes

0.1 29/03/2019 Initial draft

0.2 15/05/2019 The GM EUR Steering Group agreed the following changes to the policy:- Commissioning Criteria – Following sentence added ‘Applications should include costs (giving three quotes or stating why less than three are available)’ Following the above amendment the GM EUR Steering Group approved the policy to go out for a period of clinical engagement.

0.3 28/09/2019 The GM EUR Steering Group reviewed the feedback received during the period of clinical engagement and agreed the following changes:- Funding Mechanism – Added ‘including three quotes for the device and software’. Clinical Exceptionality Section updated to read: Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy Treatment/Procedure – ‘light tech’ amended to read ‘lite tech’.

0.4 20/11/2019 The GM EUR Steering Group reviewed the changes requested at the last meeting and approved these. They also agreed the following changes:- Policy Inclusion Criteria – The following paragraph has been added: The device once funding is approved will be considered to be the property of the individual and they (the individual) are responsible for any insurance / maintenance arrangements. Replacement devices and / or replacement software will be considered in the same way as new requests and the same funding mechanism will apply. Funding Mechanism – Amended to read Individual prior approval at triage (up to a value of £1,000) provided the patient meets the above criteria….. Following the above changes the GM EUR Steering Group approved the policy to progress through the governance process.