19
Greater Manchester EUR Policy Statement on: Orthoses, Bespoke Orthoses & 24-hour Posture Management GM Ref: GM043 Version: 2.0 (20 November 2019)

Greater Manchester EUR Policy Statement on: … Policies/GM Orthoses...Greater Manchester EUR Policy Statement on: Orthoses, Bespoke Orthoses & 24-hour Posture Management GM Ref: GM043

  • Upload
    others

  • View
    9

  • Download
    0

Embed Size (px)

Citation preview

Greater Manchester EUR Policy Statement on:

Orthoses, Bespoke Orthoses & 24-hour Posture Management GM Ref: GM043 Version: 2.0 (20 November 2019)

GM Orthoses Policy v2.0 FINAL Page 2 of 19

Commissioning Statement

Orthoses, Bespoke Orthoses & 24-hour Posture Management Policy Exclusions (Alternative commissioning arrangements apply)

Orthoses provided locally under a service specification are excluded from this policy but may be subject to audit. 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).

Policy Inclusion Criteria

This policy assumes that there are local commissioning arrangements in place supported by a service specification for the supply of ‘off the shelf’ orthoses. New 'Off the Shelf' and Standard Orthoses

'Off the Shelf' Orthoses

'Off the shelf' orthoses are those products which are not patient specific and are ordered to a standardised sizing protocol. These can be considered stock orthoses and can be held in store for distribution when required. 'Off the shelf' orthoses are supplied through local service specifications and patients should be referred in the normal way. These include:

Stock functional foot orthoses

Basic stock ankle foot orthoses

Basic stock knee orthoses

Basic stock spinal orthoses

Basic stock upper limb orthoses Standard Orthoses

Standard orthoses are those products which are patient specific when an 'off the shelf' orthotic product will not meet the biomechanical need. Standard orthoses are supplied through local service specifications and patients should be referred in the normal way. These include:

Functional foot orthoses: When an 'off the shelf' orthosis will not accurately match the patients foot anatomy or provide accurately directed force application

Total contact foot orthoses: When an orthoses is required to redistribute plantar pressure

Footwear: When a patients foot anatomy cannot be accommodated within standard 'high street' footwear

Footwear adaptations

Ankle foot orthoses: When an 'off the shelf' orthosis will not accurately match the patients anatomy or provide the required biomechanical force application

Knee orthoses: When an 'off the shelf' orthosis will not accurately match the patients anatomy or provide the required biomechanical force application

Knee ankle foot orthoses

Hip knee ankle foot orthoses

GM Orthoses Policy v2.0 FINAL Page 3 of 19

Spinal Orthoses: When an 'off the shelf' orthosis will not accurately match the patients anatomy or provide the required biomechanical force application

Upper limb orthoses: When an 'off the shelf' orthosis will not accurately match the patients anatomy of provide the required biomechanical force application

Protective head orthoses

Funding Mechanism

Monitored approval: Referrals may be made in line with the criteria without seeking funding. NOTE: May be the subject of contract challenges and/or audit of cases against commissioned criteria.

New Complex / Specialist: Non Standard Orthoses

Where an 'off the shelf' orthosis cannot be used, OR where no standard orthosis is available for the patient - prior to the referral for a non-standard orthosis the referrer must seek approval for funding for that assessment. NOTE: if the request is for purely cosmetic reasons it will not be funded unless exceptional circumstances apply. Non-standard orthoses include:

Non-standard functional foot orthoses

o Provided for cosmetic enhancement over standard orthoses

o Carbon fibre functional foot orthoses

o When the requirement for the functional foot orthoses are for sporting purposes only

Non-standard footwear

o When the requirement for footwear is for cosmetic purposes

o When the requirement for footwear is for sporting purposes only

o When the requirement for footwear is for socio-economic purposes only

o When the footwear does not provide biomechanical control e.g. soft slippers and backless sandals

Non-standard ankle foot orthoses

o Provided for cosmetic enhancement over standard orthoses

o When the requirement for the ankle foot orthoses is for sporting purposes only

Knee orthoses

o Provided for cosmetic enhancement over standard orthoses

o When the requirement for a knee orthosis is for sporting purposes only

o Carbon fibre knee orthoses

Non-standard knee ankle foot orthoses

o Provided for cosmetic enhancement over standard orthoses

o Stance phase control knee ankle foot orthoses

Non-standard hip knee ankle foot orthoses

o Reciprocating gait orthoses

Spinal orthoses

o Provided for cosmetic enhancement over standard orthoses

Upper limb orthoses

o Provided for cosmetic enhancement over standard orthoses

GM Orthoses Policy v2.0 FINAL Page 4 of 19

o Carbon fibre upper limb orthoses Stage 1: Approval for Assessment

The application should include the following:

The reason why the standard device is unsuitable OR a statement that a standard device is not available.

A statement of the additional clinical benefit that will be derived from the supply of this device over and above routinely prescribed items.

Stage 2: Approval for production of orthoses

After referral and before production of the orthosis the provider must seek funding approval. The application should include the following:

A description of the condition and the rationale behind the provision of the bespoke orthosis

A description of the orthosis and the benefits to the patient over no orthosis and, or a standard orthosis

The full cost of the bespoke orthosis

If more than one is needed the application should include the reason for duplicate provision

Funding Mechanism

Individual prior approval at Clinical Triage provided the responses to the questions above are felt to indicate clinical need. Requests must be submitted with all relevant supporting evidence.

24-hour posture management

24-hour postural management helps to prevent or manage complications such as contracture, structural changes in the skeletal system, and to improve an individual's quality of life. These can include specialised mattresses and sleep systems, wheel chair adaptations, standing frames and other postural management inserts for seating etc. Most of these are available through local equipment stores. If a system is needed that is not locally available, then an application for funding can be made. The application must include the following information:

A description of the underlying condition and the rationale behind the provision of this particular postural management system.

A description of the postural management system and the benefits to the patient over no postural management system and/or a postural management system available from the local service.

The full cost of the postural management system.

If the postural management system has been requested as part of a package of care on discharge from a specialist centre, e.g. spinal injury, then copies of any discharge plan or letter stating the need for this particular postural management system must also be included in the application.

Funding Mechanism

Individual prior approval at Clinical Triage provided the responses to the questions above are felt to indicate clinical need. Requests must be submitted with all relevant supporting evidence.

GM Orthoses Policy v2.0 FINAL Page 5 of 19

Replacement / Spare Orthoses

Where existing orthoses have been outgrown or have worn out they can be replaced with a comparable orthosis (like for like allowing for improved technology). Where it is not possible for an individual to function without the orthosis and a spare is considered essential by the orthotist, a single spare may be provided. Funding Mechanism

'Off the shelf' or standard orthoses (see lists above): Monitored approval: Can be supplied in line with the criteria without seeking funding. NOTE: May be the subject of contract challenges and/or audit of cases against commissioned criteria. All other orthoses: Individual prior approval at Clinical Triage provided there is clinical need. Requests must be submitted with all relevant supporting evidence. Orthoses will not be supplied where:

There is no specific clinical or biomechanical need

The short-term need has passed and the patient no longer requires replacements

The orthoses is being supplied as a placebo

They are being supplied only for reasons other than enhanced functioning or improved posture

The need is for sporting requirements only

The following can be used as a guide when assessing requests:

Table of suggested number, frequency and replacement:

Product Group Standard NHS Provision when Clinically required

Orthotic Footwear Period of rapid change in size or clinical need - One pair Period of slow change in growth or clinical need - Two pairs of serviceable boots or shoes supplied after the trial period completed. Replaced immediately when no longer clinically effective or patient has outgrown. For patients clinically at risk of harm or deterioration, the Orthotist may consider exceptional circumstances. It is the patient’s responsibility to check the condition of the footwear issued at regular intervals. It is recommended a locally agreed Standard Operating Procedure or policy is in place detailing how footwear can be repaired, and who is responsible for the cost. Footwear provided to the patient are the property of the hospital and patients must ensure footwear issued are maintained. However, replacements must be issued when beyond economic repair if still clinically required.

GM Orthoses Policy v2.0 FINAL Page 6 of 19

Footwear adaptations – raises, rockers, sockets for callipers

Period of rapid change in size or clinical need – One pair Period of slow change in growth or clinical need - Two pair at any given time. Stable clinical presentation - Three in the first year following the initial referral to department. One in consecutive years thereafter. Replacements should be issued if size or clinical circumstances change.

Foot Orthoses One or one pair at any given time. It expected that patients transfer their Foot Orthoses into alternative shoes as required. Activity, patient weight, shoe design, material choice and insole thickness influence longevity. Patients should be advised (at supply) the expectant lifespan of their orthoses. They should also be advised on how to seek repair or replacement when the current orthoses no longer meet their needs. For patients at high risk the Orthotist may consider exceptional circumstances.

Ankle Foot Orthoses

(AFO)

One orthosis or One pair depending clinical presentation. Patients who require long term input, have no changing clinical need, and are unable to cope with daily activities without, may be issued with a second AFO to ensure servicing and safety. The timescale is dependent on condition and circumstance and therefore should be decided by the Orthotist. They will be replaced when beyond economic repair, outgrown or no longer clinical effective.

Knee Ankle Foot Orthoses

(KAFO)

Two per limb as required at any given time. Second supplied after trial period completed. They will be replaced when beyond economic repair, outgrown or no longer clinical effective.

Temporary devices (wrist splints, stock fabric AFOs, temporary footwear, etc.)

One orthosis. Due to the breadth of clinical input the Orthotist should exercise their right of autonomy to ensure patients are safe and provided with cost effective treatment.

GM Orthoses Policy v2.0 FINAL Page 7 of 19

Graduated Compression Hosiery *

*If applicable to service

Two per limb as required initially and then discharged to GP care. If to be managed by the Orthotic service long term Two per limb every 6 months (i.e. four per limb per year).

Abdominal Supports, Fabric belts & Truss

If used throughout the day, on a regular basis - Two at any given time

If used infrequently or sparingly – One at any given time

Repairs As required. If repairs seem too frequent then consideration is given to changes to specification.

Repairs should not be undertaken to adapted retail footwear unless adapted component requires refurbishment

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.

GM Orthoses Policy v2.0 FINAL Page 8 of 19

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

Policy Statement ...................................................................................................................................... 9

Equality & Equity Statement ..................................................................................................................... 9

Governance Arrangements ....................................................................................................................... 9

Aims and Objectives ................................................................................................................................. 9

Treatment / Procedure ............................................................................................................................ 10

Epidemiology and Need ......................................................................................................................... 11

Adherence to NICE Guidance ................................................................................................................ 11

Audit Requirements ................................................................................................................................ 11

Date of Review ....................................................................................................................................... 11

Glossary ................................................................................................................................................. 11

References ............................................................................................................................................. 13

Governance Approvals ........................................................................................................................... 13

Appendix 1 – Evidence Review .............................................................................................................. 14

Appendix 2 – Diagnostic and Procedure Codes ...................................................................................... 17

Appendix 3 – Version History ................................................................................................................. 18

GM Orthoses Policy v2.0 FINAL Page 9 of 19

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 [email protected].

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.

GM Orthoses Policy v2.0 FINAL Page 10 of 19

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.

Treatment / Procedure Orthotics is a specialty involving the application of external devices to the body to support and improve posture, function and mobility and to manage pain and deformity. 'Orthoses' is the term used to describe these external devices which includes, but is no limited to, insoles, braces, splints, calipers, footwear, spinal jackets and helmets. Compression hosiery can sometimes be provided as part of the orthotics service. Orthotists are generally the designated professionals responsible for the assessment, prescription, design, manufacture and fitting of orthoses to patients. The role of the orthotist is to consider and discuss with the patient the type of orthoses that will best meet his or her needs. Increasingly, this role is undertaken by other allied health professionals involved in a patient’s care such as podiatrists, physiotherapists and others. Orthotics services provide treatment options for people with a wide range of conditions and orthotists work closely with several clinical specialties within the NHS including diabetes care, elderly medicine, neurology, orthopaedics, paediatrics, stroke and trauma teams. The correct supply and fitting of orthoses can help improve quality of life by reducing pain, keeping people mobile and independent, and preventing more invasive and expensive interventions like surgery, amputation or the need for social care. Thus, the provision of orthotics plays a major role in many rehabilitation programmes. The provision of orthoses has a beneficial impact on a range of clinical conditions by relieving pain, increasing mobility, protecting tissues and promoting healing along with a whole host of other benefits, including improved independence and self-image. The range of clinical conditions benefiting from orthoses includes chronic diseases and trauma as well as neurological, musculoskeletal and congenital conditions. A number of these remain as policy priorities for the Government and the NHS, examples of which are set out below:

Diabetes: prevention and reduction of ulceration rates and amputation

Stroke and other neurological conditions such as multiple sclerosis and cerebral palsy

Chronic Obesity: often leading to Type 2 diabetes and musculoskeletal problems

Cancer: managing the side effects of chemotherapy (peripheral neuropathy)

Cardiovascular, including peripheral disease: effects of poor circulation

Degenerative conditions: rheumatoid arthritis and osteoarthritis

Congenital conditions: spina bifida

Spinal cord injury and scoliosis

Complications of viral infections such as polio

Common musculo-skeletal conditions and sports injuries: maintaining mobility and returning people to work sooner

Treatment of the frail and elderly such as falls prevention Rationale behind the policy statement

As technology and materials develop, more and more orthoses become available and have a key role to play in improving outcomes and reducing other interventions as the demand increases year on year.

GM Orthoses Policy v2.0 FINAL Page 11 of 19

This policy is aimed at ensuring that all orthoses are appropriate to the individuals needs and that the overall resource is targeted at the individuals who will get the most benefit.

Epidemiology and Need Orthoses support several conditions and specialties and no specific epidemiology figures are available. Orthoses are accessed in 3 ways:

1. Over the counter orthoses: This includes e.g. knee braces and sporting splints

2. 'Off the shelf' and standard orthoses

3. Complex / specialist: Non-standard orthoses Data is not routinely collected for all of the above.

Adherence to NICE Guidance There is no NICE guidance 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 Five years from the date of the last review, 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

Ankle foot orthoses (AFOs)

A brace, usually made of plastic, that is worn on the lower leg and foot to support the ankle, hold the foot and ankle in the correct position and correct foot drop.

Biomechanical Relating to the mechanical laws concerning the movement or structure of living organisms.

Braces A device fitted to something, in particular a weak or injured part of the body, to give support.

Calipers A metal support for a person's leg.

Complex / Specialist: Non Standard Orthoses

Complex or specialist orthoses made specifically to fit one individual (made to measure).

Compression hosiery Specialized stockings designed to help prevent the occurrence of, and guard against further progression of, venous disorders such as edema, phlebitis and thrombosis. Compression hosiery are elastic garments worn around the

GM Orthoses Policy v2.0 FINAL Page 12 of 19

leg, compressing the limb.

Footwear Outer coverings for the feet, such as shoes, boots, and sandals.

Helmets Hard or padded protective hats.

Insoles A removable inner sole worn in a shoe to improve the fit.

Knee ankle foot orthoses (KAFOs)

A brace, usually made of plastic, that is designed to control knee and ankle motion; extends from the upper portion of the thigh, crossing the knee and ankle, and terminating at the toes.

Knee braces Supports that you wear for a painful or injured knee. Some people use them to prevent knee injuries during sports. Braces are made from combinations of metal, foam, plastic, elastic material and straps. They come in many sizes, colors and designs.

Neurology The branch of medicine dealing with the nervous system.

'Off the Shelf' and Standard Orthoses

Ready to use (often mass produced) but may require adaptation to fit the individual using them.

Orthopaedics The branch of medicine dealing with bones and joints.

Orthoses A brace, splint, or other artificial external device serving to support the limbs or spine or to prevent or assist relative movement.

Orthotist Clinician responsible for the prescription, manufacture and management of orthoses.

Paediatrics The branch of medicine dealing with children.

Placebo A medicine or procedure prescribed for the psychological benefit to the patient rather than for any physiological effect.

Postural management A programme of suitable handling, treatment and positioning of children that promotes motor development and reduces the risk of postural deformity.

Shoe adaptations Something that is done to the outside of the shoe for a variety of reasons, including: a socket for a calliper, a wedge or flare to alter your foot position and a raise for a short leg.

Shoe inserts Something that is done to the inside of the shoe.

Socio-economic Relating to or concerned with the interaction of social and economic factors.

Spinal brace A device fitted on the back to give support to the spine.

Spinal jacket A molded jacket, also called a thoracolumbosacral orthosis (TLSO), provides rigid stabilization to treat a number of spinal conditions, including spinal fractures and scoliosis. A molded jacket is a total-coverage brace.

Splints A strip of rigid material used for supporting and immobilising a limb.

Standard orthoses Orthoses produced to a general template and adjusted to fit (NOT made to measure).

Upper limb orthoses

A brace, splint, or other artificial external device serving to support the upper limbs or to prevent or assist relative movement.

GM Orthoses Policy v2.0 FINAL Page 13 of 19

References

1. Greater Manchester Effective Use of Resources Operational Policy

2. Improving the Quality of Orthotics Services in England, NHS England, 19 November 2015

3. Scottish Orthotic Services Review, Commissioned by the Rehabilitation Technology Services Advisory Group, May 2005

4. Centre for Economics and Business Research Ltd, The economic impact of improved orthotic services provision; A review of some of the financial and economic benefits of a better functioning system for the provision of orthotic services ; Report for the British Healthcare Trades Association (BHTA)

5. NHS England Orthotics service specification document

Governance Approvals

Name Date Approved

Greater Manchester Effective Use of Resources Steering Group 19/07/2017

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

Commissioning Board)

13/11/2018

Bolton Clinical Commissioning Group 25/01/2019

Bury Clinical Commissioning Group 13/11/2018

Heywood, Middleton & Rochdale Clinical Commissioning Group 13/11/2018

Manchester Clinical Commissioning Group 13/11/2018

Oldham Clinical Commissioning Group 13/11/2018

Salford Clinical Commissioning Group 13/11/2018

Stockport Clinical Commissioning Group 13/11/2018

Tameside & Glossop Clinical Commissioning Group 13/11/2018

Trafford Clinical Commissioning Group 13/11/2018

Wigan Borough Clinical Commissioning Group 13/11/2018

GM Orthoses Policy v2.0 FINAL Page 14 of 19

Appendix 1 – Evidence Review

Orthoses, Bespoke Orthoses & 24-hour Posture Management GM043

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. Comparisons of different types of orthosis for specific conditions were found but no evidence based or cost effectiveness reviews were found. Guidance on the commission of and a model service specification for orthotic services was found.

Summary of the evidence As these are aids to normal functioning and not a specific treatment or intervention there is no current evidence of effectiveness relating to the overall use of orthoses There are NHS England guidelines for the commissioning of a local orthotic service with a supporting model for the development of a local service specification. The references above can be used to see the background information accessed in putting this policy together. Added at review November 2019

1. LEVEL n/a Specialist Opinion NHS ORTHOTIC MANAGERS GROUP Guidelines to Accessing NHS Orthotic Services and Orthosis Provision Eligibility - Last updated May 2019

Orthotic Treatment not provided within standard NHS Orthotic Service Contract

Functional Electrical Stimulation. (Nb. Patients should have access to services that offer F.E.S. treatment. This may be an alternative service or additionally provided by the Orthotic Service under additional funding)

Walking aids, buggies, wheelchairs and assistive devices

Orthoses of low clinical effectiveness, where there is either: 1) a lack of robust evidence of clinical effectiveness, OR 2) a perceived effectiveness by the treating clinician OR 3) there are significant safety concerns

Orthoses which are clinically effective but where more cost-effective products are available

Orthoses that have no identifiable outcome or goal

Any Specialised product where there is not sufficient expertise and knowledge by the local team to ensure effectiveness. Commissioning arrangements should be in place to ensure local patients receive specialist intervention if not provided by the local provider (such as; Scoliotic bracing, stance phase KAFO, and Functional Electrical Stimulation)

Where the local Orthotic Service is unable to cater for the needs of a local patient, funding arrangements must be in place to allow the patient to be seen by alternative providers (such as; specialist products, complex footwear, Knee Ankle Foot Orthoses)

GM Orthoses Policy v2.0 FINAL Page 15 of 19

Table of recommended numbers of orthoses Product Group Standard NHS Provision when Clinically required

Orthotic Footwear Period of rapid change in size or clinical need - One pair Period of slow change in growth or clinical need - Two pairs of serviceable boots or shoes supplied after the trial period completed. Replaced immediately when no longer clinically effective or patient has outgrown. For patients clinically at risk of harm or deterioration, the Orthotist may consider exceptional circumstances. It is the patient’s responsibility to check the condition of the footwear issued at regular intervals. It is recommended a locally agreed Standard Operating Procedure or policy is in place detailing how footwear can be repaired, and who is responsible for the cost. Footwear provided to the patient are the property of the hospital and patients must ensure footwear issued are maintained. However, replacements must be issued when beyond economic repair if still clinically required.

Footwear adaptations – raises, rockers, sockets for callipers

Period of rapid change in size or clinical need – One pair Period of slow change in growth or clinical need - Two pair at any given time. Stable clinical presentation - Three in the first year following the initial referral to department. One in consecutive years thereafter. Replacements should be issued if size or clinical circumstances change.

Foot Orthoses One or one pair at any given time. It expected that patients transfer their Foot Orthoses into alternative shoes as required. Activity, patient weight, shoe design, material choice and insole thickness influence longevity. Patients should be advised (at supply) the expectant lifespan of their orthoses. They should also be advised on how to seek repair or replacement when the current orthoses no longer meet their needs. For patients at high risk the Orthotist may consider exceptional circumstances.

AFO One orthosis or One pair depending clinical presentation. Patients who require long term input, have no changing clinical need, and are unable to cope with daily activities without, may be issued with a second AFO to ensure servicing and safety. The timescale is dependent on condition and circumstance and therefore should be decided by the

GM Orthoses Policy v2.0 FINAL Page 16 of 19

Orthotist. They will be replaced when beyond economic repair, outgrown or no longer clinical effective.

KAFO Two per limb as required at any given time. Second supplied after trial period completed. They will be replaced when beyond economic repair, outgrown or no longer clinical effective.

Temporary devices (wrist splints, stock fabric AFOs, temporary footwear, etc.)

One orthosis. Due to the breadth of clinical input the Orthotist should exercise their right of autonomy to ensure patients are safe and provided with cost effective treatment.

Graduated Compression Hosiery * *If applicable to service

Two per limb as required initially and then discharged to GP care. If to be managed by the Orthotic service long term Two per limb every 6 months (i.e. four per limb per year).

Abdominal Supports, Fabric belts & Truss

If used throughout the day, on a regular basis - Two at any given time If used infrequently or sparingly – One at any given time

Repairs As required. If repairs seem too frequent then consideration is given to changes to specification. Repairs should not be undertaken to adapted retail footwear unless adapted component requires refurbishment

Replacements will only be provided when the device is beyond economic repair or a change of device is required following assessment due to clinical need or change.

GM Orthoses Policy v2.0 FINAL Page 17 of 19

Appendix 2 – Diagnostic and Procedure Codes

Orthoses, Bespoke Orthoses & 24-hour Posture Management GM043

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

GM043 – Orthoses, Bespoke Orthoses & 24-hour Posture Management

OPCS-4 Procedure Codes

Other specified other external support of limb (there are no codes available in OPCS-4 for this procedure so

might be coded to this) X498

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

Fitting and adjustment of orthopaedic device Z467

GM Orthoses Policy v2.0 FINAL Page 18 of 19

Appendix 3 – Version History

Orthoses, Bespoke Orthoses & 24-hour Posture Management GM043

Version Date Summary of Changes

0.1 01/03/2017 Initial draft

0.2 15/03/2017 The GM EUR Steering Group meeting on 15 March 2017, agreed the following amendments to the policy:

Title of policy changed from 'Orthotics' to 'Orthotics, Bespoke Orthotics & 24-hour Posture Management'

Commissioning Statement: Policy Inclusion Criteria

Funding mechanism of Monitored Approval added under the heading 'Standardised ('off the shelf') Orthoses'

Funding mechanism of Individual prior approval at Clinical Triage added under the headings 'Bespoke Orthoses' and '24-hour posture management'

Under 'Bespoke Orthoses' heading, 'Stage 1' and 'Stage 2' added to the sub-headings.

Under the section ‘Orthoses will not be supplied where’ the 4th bullet point reworded slightly from ‘They are being supplied for only socio-economic reasons ‘ to ‘They are being supplied only for socio-economic reasons’. Also the word only in the 5th bullet point highlighted to differentiate from those with a clinical need requiring orthoses for sport.

The GM EUR Steering Group also agreed that following the above amendments the policy could go out for a period of clinical engagement.

0.3 19/07/2017 The GM EUR Steering Group meeting on 19 July 2017, agreed the following changes to the policy following review of feedback from clinical engagement:

Throughout the policy references to 'orthotic' and 'orthotics' have been changed to 'orthosis' and 'orthoses' respectively where appropriate, including the title of the policy.

Policy Exclusions: The words 'but may be subject to audit’ added to end of the first paragraph.

The heading 'Standardised ('off the shelf') Orthoses' changed to 'New 'Off the Shelf' and Standard Orthoses' and whole section rewritten.

The heading 'Bespoke Orthoses' changed to ' New Complex / Specialist: Non Standard Orthoses' and section rewritten up to 'Stage 1: Approval for Assessment', and funding mechanism reworded for clarity.

24-hour posture management: Funding mechanism reworded for clarity.

Section added for ‘Replacement / Spare Orthoses’

Orthoses will not be supplied where: 'socio economic reasons' amended to read 'reasons other than enhanced fucntioning or improved posture' on 4th bullet point.

Epidemiology and Need: Numbered list reworded to reflect changes in 'Commissioning Statement'

Glossary: Amended to reflect changes in 'Commissioning Statement' Subject to the above changes being made the GM EUR Steering Group agreed the policy could progress through the governance process.

0.4 24/04/2018 Procedure and Diagnostic Codes added to Appendix 2

0.5 01/10/2018 Branding changed to reflect change of service from Greater Manchester Shared

GM Orthoses Policy v2.0 FINAL Page 19 of 19

Services to Greater Manchester Health and Care Commissioning.

1.0 13/11/2018 Approved by Greater Manchester Directors of Commissioning / Greater Manchester Chief Finance Officers (Delegated authority given to approve policy by Greater Manchester Joint Commissioning Board).

Commissioning Statement: Best Practice Guidelines section added

1.1 29/01/2019 Links updated as documents have all moved to a new EUR web address.

Commissioning Statement: ‘Best Practice Guideline’ section moved to bottom of ‘Commissioning Statement’

1.2 01/08/2019 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

2.0 20/11/2019 Policy reviewed by GM EUR Steering Group and the following changes were agreed:

Policy Inclusion Criteria: Table of suggested number, frequency and replacement of orthoses added. Date of Review: Date amended to state: Five years from the date of the last review, unless new evidence or technology is available sooner. Evidence Review: NHS ORTHOTIC MANAGERS GROUP Guidelines to Accessing NHS Orthotic Services and Orthosis Provision Eligibility - Last updated May 2019 added.