item number: 8.3 governing body meeting · the potential full year impact for the ccg based on...

Our Vision – to Improve the Health & Wellbeing of our Communities

Item Number: 8.3

GOVERNING BODY MEETING Meeting Date: 22nd July 2015 Report’s Sponsoring Governing Body Member: Richard Mellor

Report Author: Richard Mellor/ Gaye Hanson

1. Title of Paper: Mitigating actions in respect of possible under-delivery of QIPP in 2015/16 2. Strategic Objectives supported by this paper: (check those which apply) ☒ To create a viable & sustainable organisation, whilst facilitating the development of a different, more innovative culture ☐ To commission high quality services which will improve the health & wellbeing of the people in Scarborough & Ryedale ☐ To build strong effective relationships with all stakeholders and deliver through effectively engaging with our partners ☐ To support people within the local community by enabling a system of choice & integrated care ☒ To deliver against all national & local priorities incl QIPP and work within our financial resources 3. Executive Summary: The QIPP plan for 2015/16 has a target of £6m savings, with large elements predicated on the ability to reduce non elective admissions, in conjunction with the Better Care Fund aspirations. Early indications of non elective activity are that activity remains high, with a consequent pressure on our financial position. This paper proposes actions to the Governing Body to mitigate the impact on our financial position in year from under-delivery of QIPP savings. The Governing Body are requested to review the proposals in the attached paper, and decide whether to accept the proposals. 4. Risks relating to proposals in this paper: Reputational from impact of decisions 5. Summary of any finance / resource implications: Estimated impact for each proposal is identified in the paper 6. Any statutory / regulatory / legal / NHS Constitution implications: Alll the proposals are believed to be consistent with our legal and constitutional obligations 7. Equality Impact Assessment: The CCG would need to consider Equality impact for any decisions 8. Any related work with stakeholders or communications plan: The proposal has been shared at the Council of Clinical Reps, and discussed at the QIPP group and Finance and Contracting committee

Our Vision – to Improve the Health & Wellbeing of our Communities

For further information please contact: Name: Richard Mellor Title: Chief Finance Officer ☎: 01723 343675

9. Recommendations / Action Required The Governing Body are requested to review the proposals in the attached paper, and approve the proposed .schemes. 10. Assurance QIPP Steering Group, Finance and Contracting Committee

SCARBOROUGH & RYEDALE CLINICAL COMMISSIONING GROUP

QIPP PROGRAMME RECOVERY PLAN

July 2015

1. INTRODUCTION The purpose of this paper is to propose additional actions for consideration as part of the CCG Financial Recovery Plan for 2015/16. The QIPP steering group has identified areas where spending reductions could potentially be made in year.

2. BACKGROUND The CCG financial plan for 2015/16 is challenging, with a need to achieve £6m savings, and limited reserves to support under-delivery of savings. The plan for 2015/6 has risks to the savings which can be delivered. A key component of the QIPP plans for 2015/16 is the reduction in emergency admissions, and a number of schemes are in place to deliver this, with funding through both the Better Care Fund and the CCG. Early indications of activity for non-elective admissions show activity levels above plan, and financial pressure on the acute contract from this activity and the lack of discernible reductions associated with QIPP schemes. The potential full year impact for the CCG based on over-performance in the first two months could be as much as £2 million. The CCG is looking for the actions it can take to reduce the organisation’s financial risk in the event that the schemes in place do not deliver the savings required, particularly in respect of the reductions in non-elective admissions. This paper proposes some options to reduce the spend of the CCG in the remainder of the year through the following areas:

• Reduce the availability of Paracetamol on prescription to Adults between the ages of 18 and 65

• Increasing the number of Low Clinical Value procedures which are not routinely commissioned by the CCG;

• Requiring smoking cessation courses to have been undertaken for smokers who are referred for a procedure;

• Requiring weight management courses to have been undertaken for patients who are referred for a procedure where the patients’ BMI is excessively high or low.

3. RECOVERY PLAN PROPOSALS FOR CONSIDERATION 3.1 Paracetamol Prescribing

3.1.1 Proposal SCRCCG currently spends c£189k per annum on paracetamol prescribing, of which c £72k is for patients < 65 years (39%) and within this £10k is for paediatric prescriptions.

Under this proposal the CCG would either undertake a public campaign to encourage people to purchase their own medication wherever possible or could go further and revise its prescribing guidance for paracetamol in order to restrict access to an agreed cohort of patients only for example: > 65 year olds with chronic conditions requiring daily pain relief e.g. osteoarthritis.

3.1.2 Evidence/Rationale Recent national media publicity has highlighted the fact that the NHS spends over £80 million p/a on prescriptions for paracetamol, with each prescription on average costing £3.67. It is acknowledged that many of these prescriptions may be for volumes of pills significantly higher than the numbers that can be bought over the counter. However it is also the case that paracetamol can be purchased for as little as 19p for 16 tablets in national supermarket chains. Other CCGs have taken the lead in developing public campaigns to highlight this issue and encourage patients not to ask their doctor for a prescription for paracetamol (see Ipswich and East Suffolk CCG)

3.1.3 Impact The scope for saving will depend on the approach taken however it could be feasible to estimate a target of c£50k p/a

3.1.4 Options The Governing Body is asked to support reducing Paracetamol prescribing for patients between 18 and 65, and consider the following options:

• Undertake a public campaign to encourage people to purchase their own medication wherever possible;

• Revise prescribing guidance to restrict access to Paracetamol to agreed cohorts of patients. Authorise the Business committee to approve the prescribing guidance

3.2 Clinical Thresholds

3.2.1 Proposal Under this proposal SCRCCG would revise its thresholds for certain clinical procedures. The CCG proposes that the Service Restriction Policy and thresholds from West Essex CCG (Appendix 1) be considered for local application and in particular in relation to the following procedures where their thresholds are more detailed/ stringent that currently in place for SCRCCG:

• Arthroscopy • Blepharoplasty • Adenoidectomy

• Grommets with/without adenoidectomy • Cataracts • Asymptomatic Gall Stones • Benign Skin Lesions • Gynaecomastia

3.2.2 Impact

The 2014/15 activity levels and annual cost for each of these procedures is detailed below:

2014/15

Procedure SCRCCG Status Activity Value

Adenoidectomy Threshold less stringent than WECCG 3 £3,557

Arthroscopy No Threshold defined 159 £336,076

Asymptomatic Gall Bladder stones Threshold less stringent than WECCG 131 £290,306

Benign Skin Lesions Threshold less stringent than WECCG 175 £114,477

Blepharoplasty No Threshold defined 7 £5,896 Cataracts No Threshold defined 891 £644,523

Grommet (with/without adenoidectomy) Threshold less stringent than WECCG 61 £47,854

Gynaecomastia Threshold less stringent than WECCG 8 £16,192

Total 1435 £1,458,881 The impact of each threshold change is difficult to assess, but the CCG should consider thresholds for the treatments above where we currently do not have thresholds in place, and consider tightening the criteria for other procedures where

3.2.3 Options The Governing Body is asked to support the development of additional thresholds for SCRCCG, and authorise the Business Committee to approve thresholds based on the West Essex model.

3.3 Stop Smoking before elective surgery

3.3.1 Proposal SCRCCG referral pathways for total hip replacement and knee replacement surgery require patients to have been a non-smoker for at least 4 weeks at the point of referral. This proposal would require all patients seeking referral for an elective procedure and that are identified as smokers should be referred into a smoking cessation service – either prior to referral or prior to addition to the waiting list.

3.3.2 Evidence/Rationale The evidence for the clinical benefits of smoking cessation prior to surgery has been well documented by wide range of credible organisations (Appendix 2).

3.3.3 Impact In 2014/15 c.14,000 elective procedures (inpatient and day-case including endoscopy) were undertaken at a total cost to the CCG of £12.7m. Reported smoking prevalence in the 2013 Integrated Household Survey for Scarborough was 21.8% and for Ryedale was 15.8%. If this higher rate is applied crudely to the total elective activity figure this might therefore mean up to 3000 patients being referred to smoking cessation prior to surgery per annum.

3.3.4 Options The Governing Body is asked to support the principle of requiring smoking cessation prior to surgery, authorise officers to develop pathways which build in smoking cessation prior to surgery, and authorise the Business committee to approve those pathways.

3.4 BMI thresholds and elective surgery 3.4.1 Proposal

Figures for SCRCCG, taken from the 2012 Sport England Active People Survey shows total prevalence of adults with a BMI defined as overweight or obese as 71.1% (Scarborough District) and 73.7% (Ryedale District) against an England average of 63.8%. Within this NYCC Public Health have estimated the number of people with a BMI > 40 i.e. severely obese across Scarborough & Ryedale at 2362 currently. As per section 2.3.1 above SCRCCG current referral guidance for hip replacement and knee replacement surgery require patients with a BMI over 35 to be given appropriate support prior to referral and should demonstrate a sustained commitment to lose weight over at least a 4 month period.

This proposal would require all patients seeking referral for an elective procedure and with a BMI of > 40 to be referred for weight loss support either prior to referral or prior to being placed on the waiting list for surgery Scarborough Borough Council will be launching a Tier 2 Weight Loss Service with effect from 1st September 2015. This will offer a 12 week weight loss support programme for people with a BMI > 25. Further consideration would need to be given to the capacity within this service

and/or the scope of provision for Tier 3 Weight Management support to support this policy.

3.4.2 Evidence/Rationale

The American Society of Anesthesiologists (ASA) includes high BMI in its Physical Status Classification for determining fitness and associated risks for surgery (Appendix 3). This identifies that patients with a BMI >40 would routinely be graded as ASA III i.e. with severe systemic disease and therefore at greater risk of complications from surgery including VTE, breathing problems, delay to wound healing amongst others.

3.4.3 Options The Governing Body is asked to support the principle of requiring patients with a BMI over 35 to undertake a weight loss course prior to surgery. The Governing Body is asked to authorise officers to assess the requirements for a Tier 3 weight management support programme, and develop a business case to implement this proposal.

4. RECOMMENDATION The Governing Body is asked to review the contents of this proposal and:

• Agree the reduction/elimination of paracetamol prescribing for adults, and select an option to proceed.

• Agree the adoption/refinement of clinical thresholds in line with the WECCG policy, and Authorise the Business Committee to approve thresholds.

• Approve the adoption of a policy on smoking cessation prior to elective surgery, and Authorise officers to develop pathways which build in smoking cessation prior to surgery, and Authorise the Business committee to approve those pathways.

• Approve the adoption of weight management thresholds for elective surgery, and require officers to develop a business case to implement the proposal.

Policy Ref: WECCG35 Version: Approved: Review date:

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Service Restriction Policy West Essex CCG Policy Reference:

WECCG35

Target Audience All providers commissioned by WECCG for the provision of services

Brief Description (max 50 words)

West Essex CCG’s policy is that treatments/

interventions/ procedures not currently included in

commissioned established care pathways (as identified

for example in the Schedules to the service agreements

with acute care provides) or identified for funding

through the commissioning process are not routinely

funded.

This policy document sets out the access to treatments/

interventions/ procedures where there is a specific policy

in place:

Document Information

Version 2

Accountable Officer Clinical Director

Policy Owner Clinical Commissioner

Date Policy Approved 23rd October 2014

Approved By WECCG Health Care Commissioning Committee

Review Date

Stakeholders engaged in development/review


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Amendment History

Version Date Reviewer Name(s) Comments 2 23/06/2015 Hewitt Hyperhidrosis policy removed as it

has been replaced by Medicines Management Policy and Pathway. Tonsillectomy and Pinnaplasty policies updated, Gallstones policy added.


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Document Summary West Essex CCG’s policy is that treatments/ interventions/ procedures not currently

included in commissioned established care pathways (as identified for example in

the Schedules to the service agreements with acute care provides) or identified for

funding through the commissioning process are not routinely funded. For a number

of commissioned interventions the CCG has specific policy statements setting out

restrictions on access, based on evidence of effectiveness or relative priority for

funding. Those related to treatments/ interventions/ procedures are included within

this document; those relating to prescribing can be found on the West Essex CCG

website Medicines Management – West Essex CCG

Policy development is an on-going process and future policy on further treatments as

developed or in response to NICE Guidance/Guidelines, health technology

assessments etc. will be produced and published periodically.

This policy document sets out the access to treatments/ interventions/ procedures

where there is a specific policy in place:

Threshold Approvals – Those procedures which are commissioned by West Essex CCG on a routine basis but only for patients who meet the defined criteria set out within this policy but for which individual prior approval is not required e.g. cataract surgery. CCG notification of compliance or audit will be required according to contractual arrangements. Providers should be aware that payment may be withheld where it cannot demonstrate that patients treated meet the criteria specified.

Individual Prior Approvals - Those procedures which are commissioned by West Essex CCG but only for patients who meet the defined criteria set out within this policy and which require individual approval on a patient by patient basis.

For these procedures, the criteria listed form guidance to both the referring and treating clinicians and if a patient is deemed to meet these criteria prior approval should be sought. In instances in which eligibility is unclear the final decision is made through the application of the Exceptional Cases process.

Not Normally Funded – Those procedures which have been assessed as Low Clinical Priority by West Essex CCG and which will not be funded unless there are exceptional clinical circumstances. Applications for funding for these procedures can be made to the Individual Funding Request Team but should only be made where the patient demonstrates true clinical exceptionality.

Individual Funding Requests- West Essex CCG always allows patients the

opportunity to make specific funding requests via its Individual Funding Request

Team.

http://www.midessexccg.nhs.uk/Your%20NHS/medicines-management.htm


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INDEX

Requests may include patients with conditions for which the CCG does not have an

agreed policy, including patients with rare conditions and whose proposed treatment

is outside agreed service agreements. Such requests should not constitute a

request for a service development. For further information refer to West Essex

Individual Funding Request Policy.

Referral Process: All referrals/requests should be sent to:

Individual Funding Request Co-ordinator

NHS West Essex Clinical Commmissioning Group

Building 4, Spencer Close

St Margaret’s Hospital

Epping

Essex

CM16 6TN

Tel: 01992 566147

Fax: 01992 566148

[email protected]

mailto:[email protected]


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A Abdominoplasty or Apronectomy

Adenoidectomy

Aesthetic Facial Surgery

Arthroscopy

B Benign Skin Lesions

Blepharoplasty

Bobath Therapy

Breast Asymmetry

Breast Augmentation – Clinical (including revision and replacement)

Breast Augmentation – Cosmetic

(including revision and replacement) Breast Reconstruction

Breast Reduction

Bunion Surgery

C Carpal Tunnel Syndrome

Cataracts

Chronic Fatigue Syndrome / Myalgic Encephalomyeltis (CFS/ME)

Circumcision

Complementary and Alternative Therapies

Correction of Privately Funded Treatments

Cosmetic surgery general principles

Cosmetic Surgery on mental health

grounds

D Dilatation and Curettage/Hysteroscopy

E Endoscopic Laser Spinal Surgery

Exogen for non-union or delayed

healing of long bone fractures

F Face Lifts and Brow Lifts (Rhytidectomy)

Facet Joint Injections for Lower Back Pain

Functional Electrical Stimulation (FES)

Fertility

G Gallstones (asymptomatic)

Grommets (with or without Adenoidectomy)

Gynaecomastia (including revision surgery)

H Hair Loss

Hernias – Referral guidance

Hip Replacement surgery: Non acute

Hip Arthroscopy

Hyperhidrosis – please see medicines management policies

Hysterectomy for heavy menstrual bleeding

I J

K Knee Arthroscopy

Knee Replacement Surgery: Non- acute

L Labiaplasty (Vaginal Labia reduction/refashioning

Laser Treatment for Severe Facial Hirsutism

Laser Treatment for Soft Palate (Snoring)


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Liposuction

Lycra Dynamic Splinting for Children with Neurological Impairment

Lymphoedema Services

M Mastopexy (Breast Lift)

Minor Hand Conditions N Nipple Inversion

O P Penile Implants

Photodynamic Therapy for age-related

Macular Degeneration

Pinnaplasty/Otoplasty Plagiocephaly

Q R Repair of ear lobes

Reversal of Sterilisation (Male and Female)

Rhinophyma

S Scar Revision

Scotopic Sensitivity Sundrome (Mears- Irlen Syndrome) and Coloured filters/tinted lenses

Septoplasty and Rhinoplasty

Skin Contouring

Sleep Apnoea

Snoring and ENT consultation

Spinal Cord Simulation

T Tattoo Removal

Temporoman Dibular Joint

Replacement

Tonsillectomy

Trigger Finger

U V Varicose Vein Surgery

Varicose Vein Referral Guidelines

Vasectomy

W X

Y Z

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Policy Statement: Abdominoplasty or Apronectomy

Status: Individual Prior Approval

Abdominoplasty and apronectomy may be offered to the following groups of patients

A Those with disfiguring* scarring following trauma or previous abdominal

surgery (excluding scarring resulting from caesarean sections), resulting in

skin tethering to deep tissues and functional problems or severe pain. OR

Where it is required as part of abdominal hernia correction or other abdominal

wall surgery, OR

B Those patients from the following groups who have significant abdominal

aprons as a result of weight loss and have severe functional problems**:

Patient with excessive abdominal folds who had an initial BMI >40 and have

achieved a reduction in BMI < 25 and have maintained the BMI < 25 for at

least 2 years OR

Patient with excessive abdominal folds who have an initial BMI > 50 and have

achieved their maximum weight loss goal (which must be a minimum drop of

20 BMI points) and have maintained at that lowest weight for at least 2 years,

without fluctuation up or down.

*Contour irregularities and moderate asymmetry are predictable following surgery.

Any post-surgical cosmetic irregularities (including dog ears or unequal fat

distribution) will not be funded by the CCG for revision surgery.

**Severe functional problems include:

Recurrent intertrigo beneath the skin fold

Experiencing severe difficulties with daily living i.e. ambulatory restrictions.

These patients will need full assessment by the appropriate professional e.g.

OT prior to referral

Where previous post trauma or surgical scarring (usually midline vertical or

multiple) leads to very poor appearance and results in disabling psychological

distress or risk of infection

Abdominal wall prolapse with proven urinary symptoms.

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Problems associated with poorly fitting stoma bag

Patients who have predictable abdominal changes due to pregnancy are excluded.

All funding will for abdominoplasty/apronectomy will be for a single stage procedure.

Applications for a 2 stage abdominoplasty must be reviewed internally by the trust in

advance of applications to the CCG for funding. The application must clearly

indicate that the procedure will occur in two stages and the cost associated with this

pathway of care.

All patients who are smokers should be referred to smoking cessation services at the

initial assessment appointment.

Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed as per the CCG policy.

Approved by (committee)

West Essex Executive Commissioning Committee

Date approved: 20th June 2013

Produced by (Title): Commissioning Manager

Review date: By June 2015

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Policy Statement: Adenoidectomy

Status: Threshold

Policy:

Adenoidectomy combined with grommets may be considered in children who fulfil the criteria for grommets as follows:

The CCG will only agree to fund treatment with Grommets for children under 12

years old with bilateral otitis media with effusion (OME) under the following

circumstances:

A) There has been a period of 3 months watchful waiting from the date of the first appointment with an audiologist AND

OME persists after 3 months and the child suffers from at least one of the following:

At least 5 recurrences of acute otitis media in a year

Evidenced delay in speech development

Hearing level in the better ear of 25-30 dBHL or worse averaged at 0.5, 1, 2,

& 4 KHZ (or equivalent dBH where dBHL not available) (Hearing results

through audiologist assessment must be provided).

Hearing loss of less than 25-30 dBHL where the impact on a child’s

development, social or educational status is judged to be significant*

A second disability such as Down’s syndrome or cleft palate

OR

B) OME is overlaying sensorineural deafness or is delaying diagnosis or treatment with aids or cochlear implants (this would be an indication for immediate grommets).

*Evidence from GP or Community Healthcare professional that symptoms prevent

the child from carrying out vital educational activities or symptoms prevent the child

from carrying out other vital activities.

All other reasons for grommets in children are not funded.

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All referrals should be through an agreed pathway to optimise access to

conservative treatment and advice. Regular audit of the indications for the surgical

procedures carried out should be undertaken.

Other indications for adenoidectomy in conjunction with tonsillectomy that the

exceptional circumstances panel should consider include:

Sleep apnoea (demonstrated by a sleep study or other accepted method of

diagnosis) - a literature review by Ryan6 in 2005 was published in Thorax. This

found that, in children, including those that are obese, “adenotonsillectomy was

curative for 75-100%”. However, a Cochrane review7 (2006) noted that there is no

randomised trial data relating to adenotonsillectomy for obstructive sleep apnoea in

children and more research is needed.

Definition:

Surgical removal of the adenoids. Adenoids are an overgrowth of glandular tissue at the back of the throat, into which the nose opens

Rationale:

Clinical Evidence, last updated in November 2005 8, states that:

ventilation tubes (grommets) and adenoidectomy represents a trade-off between benefits and harms;

Adenoidectomy on its own is of unknown effectiveness.

In a Cochrane review of grommets9, the reviewers note some improvement in outcomes that look at adenoidectomy and grommet insertion compared to grommet insertion alone.

In 2005, in a randomised control trial (n=193) comparing watchful waiting with

adenotonsillectomy for otitis media, Oomen et al10 found no significant difference in

the occurrence of otitis media between the Adenotonsillectomy group and the

watchful waiting group.

Glossary:

Down's Syndrome

A genetic disorder in which the affected person usually carries an extra chromosome - 47 instead of the usual 46.

Grommet: A small bobbin-shaped tube used to keep open the incision made in the ear drum in the treatment of secretory otitis media. It acts as a ventilation tube by allowing the Eustachian tube to recover its normal function.

Otitis Media: Infection of the middle ear.


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REFERENCES

1. MRC Multicentre Otitis Media Study Group (2001). Surgery for persistent otitis

media with effusion: generalisability of results from the UK trial (TARGET). Clin. Otolaryngol (26); 417-424.

2. Rosenfeld et al (2004). Clinical practice guideline: Otitis media with effusion. Otolaryngology- Head and Neck Surgery (130);5;s95-s118.

3. Rovers, M et al (2000). The Effect of Ventilation Tubes on Language Development in Infants with Otitis Media with Effusion: A Randomised Trial. Paediatrics (106);3.

4. Paradise, J.L (2001). Effect of early or delayed insertion of tympanostomy tubes for persistent otitis media on developmental outcomes at the age of three years. NEJM (344);16;1179-1187.

5. Paradise, J.L (2005). Developmental Outcomes after Early or Delayed Insertion of Typmanostomy Tubes. NEJM (353);6;576-587.

6. Ryan, C.F (2005). Sleep 9: An approach to treatment of obstructive sleep apnoea/hypopnoea syndrome including upper airway surgery. Thorax (60);595- 604.

7. Lim, J and McKean, M (2001). Adenotonsillectomy for obstructive sleep apnoea in children. Cochrane Database of Systematic Reviews Issue 3.

8. BMJ Clinical Evidence: Otitis media with effusion (available online at http://www.clinicalevidence.com/ceweb/conditions/ent/0502/0502.pdf, free registration required.

9. Cochrane Database of Systematic Reviews. Grommets (ventilation tubes) for hearing loss associated with OME in children. http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001801/pdf .fs.html

10. Oomen. K et al (2005). Effect of adenotonsillectomy on middle ear status in children. Laryngoscope Apr;115(4):731-4. Black's Medical Dictionary. 40th Edition. A&C Black. London 2002.




Date approved: October 2016


Review date: August 2016

http://www.clinicalevidence.com/ceweb/conditions/ent/0502/0502.pdf

http://www.clinicalevidence.com/ceweb/conditions/ent/0502/0502.pdf

http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001801/pdf.fs.html




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Policy statement: Aesthetic Facial Surgery


Funding should be considered for:

Anatomical abnormalities in children <19 years, likely to cause impairment of normal emotional development

Pathological abnormalities

Correction of post traumatic bony and soft tissue deformity of the face

Please refer also to the cosmetic surgery general principles prior to submitting an exceptional funding request.





Produced by (Title): Consultant in Public Health

Review date: By August 2016


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Policy statement: Arthroscopy (please note that knee and hip elements

of policy have been replaced by separate policies)

Status: Threshold

Referral Criteria:

Knee Arthroscopy

There is no evidence for the use of an invasive procedure like arthroscopy for the investigation of knee pain. MRI is effective in diagnosis. Diagnostic arthroscopy may be considered in the following:

1. Medial knee pain where the Plica Syndrome is suspected 2. Chondromalaica patellae

Therapeutic arthroscopy is indicated in the following:

Meniscal surgery

Removal of loose body where there is a clear history of locking and other treatment has failed

Repair of cruciate ligament

Synovectomy

The use of arthroscopy with lavage / debridement :

does not improve pain or ability to function compared to placebo (sham

surgery)

leads to little or no difference in pain or ability to function

debridement may improve pain compared to washout

Autologous Chondrocyte Implantation (ACI) should not be undertaken except as part of a study.

Hip Arthroscopy

In diagnosis, HA was found to be more sensitive and specific than MRI and MRI arthrography. It is useful in patients with chronic (>6m) hip pain who have negative radiological investigations.


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Therapeutic HA is indicated for the following :

Loose bodies

Labrum lesions ( tears, flaps)

Septic arthritis – for debridement and lavage Shoulder Arthroscopy

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In diagnosis of shoulder pain, examination by a specialist can rule out rotator cuff

tears.

Ultrasound or MRI is effective in diagnosis although ultrasound was better at picking

up partial tears.

Shoulder arthroscopy as treatment is indicated in: Patients with adhesive capsulitis when other treatments have been tried and have not been successful. The patient would have had activity modification, physiotherapy and an exercise programme, oral analgesics including NSAID’s, intra-artucular steroid injections and MUA before shoulder arthroscopy is considered.

Definition: An arthroscopy is a form of keyhole surgery that is used to look inside a joint and

repair any damage that has occurred.

An arthroscopy has two main uses:

diagnosis - an arthroscopy can help diagnose problems with the joint, such as joint pain, stiffness, or limited range of joint movement, and

treatment - an arthroscopy can be used to repair damage to the joint.

The Arthroscopies covered by this policy are:

Knee Arthroscopies

Hip Arthroscopies

Shoulder Arthroscopies

Rationale: In the shoulder in the majority of circumstances a clinical examination (history and

examination) by a competent clinician will give a diagnosis and demonstrate if

internal joint derangement is present. If there is diagnostic uncertainty despite

competent examination or if there are “red flag” symptoms/signs/ conditions then an

MRI scan might be indicated.


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Red flag symptoms or signs include recent trauma, constant progressive non-

mechanical pain (particularly at night), previous history of cancer, long term oral

steroid use, history of drug abuse or HIV, fever, being systematically unwell, recent

unexplained weight loss, persistent severe restriction of joint movement, widespread

neurological changes, and structural deformity. Red flag conditions include infection,

carcinoma, nerve root impingement, bony fracture and avascular necrosis.

Evidence:

Knee arthroscopy for the treatment of Osteoarthritis

Both a NICE procedure overview and Cochrane protocol review highlighted that

there is uncertainty regarding the efficacy of arthroscopic knee washout with or

without debridement where the key outcomes are relief of pain and reduction of

mechanical symptoms. The NICE procedure overview was based on a small

evidence base of six randomised controlled trials, one non-randomised controlled

trial and three case series2. Both documents pointed to a blinded random controlled

trial, the results of which brought into question the efficacy of arthroscopy. The trial

reported that arthroscopy with debridement had no clinically meaningful difference

from ‘placebo surgery.

Diagnostic knee arthroscopy for investigation of abnormalities of the knee

Diagnostic arthroscopy is considered to have high diagnostic accuracy. However,

this invasive and expensive procedure might be more cost effectively replaced by

greater use of magnetic resonance imaging (MRI). Case series data suggests that

MRI might be an appropriate alternative to arthroscopy.

GLOSSARY:

Arthroscope A narrow tube with a light source attached to a tiny video camera, which transmits pictures back to a TV monitor. The arthroscope is about the diameter of a pencil.

Arthroscopic knee washout

An arthroscopic knee washout (lavage) involves flushing the joint with fluid, which is introduced through small incisions in the knee.

Debridement The removal of loose debris around the knee joint

MRI Magnetic Resonance Imaging is useful for looking at soft tissue structures, including identification of disc prolapse and nerve root prior to surgery; and early detection of malignancy and infection.

Osteoarthritis Osteoarthritis of the knee is the result of progressive


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degeneration of the cartilage of the joint surface.

Randomised Control Trial

Randomised controlled trials are medical studies designed to test whether a trial treatment works. Patients are split into groups in a random way. One group is given the treatment being tested while another group (called the comparison or control group) is given an alternative treatment. This could be a different type of drug, or a dummy treatment (a placebo). Researchers then compare the effects of the different treatments.

Synovectomy Excision of a portion or all of the synovial membrane of a joint

REFERENCES:

NICE. IPG230 Arthroscopic knee washout, with or without debridement, for the treatment of osteoarthritis. National Institute for Health and Clinical Excellence Interventional Procedures Programme, August 2007.

NICE IPG213 Arthroscopic femoro-acetabular surgery for hip impingement syndrome. National Institute for Health and Clinical Excellence Interventional Procedures Programme. March 2007

NICE CG59 the care and management of osteoarthritis in adults. National Institute for Health and Clinical Excellence Clinical Guideline. February 2008.

Laupattarakasem W, Laopaiboon M and Sumananont C. Arthroscopic debridement for knee osteoarthritis. (Protocol) Cochrane Database of Systematic Reviews 2005, Issue 1. Art. Number: CD005118.

Bandolier





Produced by (Title):



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Arthroscopy Surgical Threshold Checklist BACK TO INDEX

Patient Details

Name:

Hospital Number: NHS Number:

Date of Birth:

Address: Postal Code:

Telephone Number:

Clinician Details

Name of Referring

Clinician:

Referrer's Address or

Stamp: Postal Code:

Referrer's Telephone

Number:

Referrers Email

Address:

Name of Trust being

Referred to:

Criteria Checklist - patients should meet the following criteria: tick boxes as appropriate

A KNEE ARTHROSCOPY:

Required for a diagnostic purpose where patient suffers from:

Medial knee pain where the Plica Syndrome is suspected

OR

Chondromalaica patellae


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Required for a therapeutic purpose for:

Meniscal surgery

OR Removal of loose body where there is a clear history of locking and other treatment has

failed

OR Repair of cruciate ligament

OR Synovectomy

B HIP ARTHROSCOPY:

Required for a diagnostic purpose where patient suffers from:

Chronic (>6m) hip pain who have negative radiological investigations.


Loose bodies

OR Labrum lesions ( tears, flaps)

OR Septic arthritis – for debridement and lavage

C

SHOULDER ARTHROSCOPY:


Patients with adhesive capsulitis when other treatments have been tried and have not been

successful.

AND

The patient has had activity modification, physiotherapy and an exercise programme, oral

analgesics including NSAID’s, intra-artucular steroid injections and MUA


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Additional Information

Significant Medical history

Current medication

Other relevant information

Form completed by:

Title:

Authorising Signature:

Dated:


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Policy statement: Benign Skin Lesions

Status: Threshold and Individual Prior Approval

Clinically benign skin lesions/conditions should not be removed or treated on purely cosmetic grounds.

Lesions included in this policy include:

Benign pigmented moles

Comedones

Corn/callous

Lipoma

Milia

Molluscum contagiosum

Sebaceous cysts (epidermal or pilar

cysts)

Seborrhoeic keratoses (basel cell papillomata)

Skin tags including anal tags

Spider naevus (telangiectasia)

Warts

Xanthelasma

Neurofibromata

Threshold Approval

If a benign skin lesion of the eye obscures vision or is causing a separate ocular problem then the patient can be referred to an ophthalmologist for removal A patient with a skin or subcutaneous lesion that has features suspicious of malignancy must be referred to an appropriate specialist for urgent assessment

Individual Prior Approval (partial exclusion):

Size or location that interferes with physical function or routine daily activity and prevents the individual from fulfilling work/study/carer or domestic responsibilities Lesions on the face where the extent, location and size of the lesion can be regarded as disfigurement Removal of lesions for other clinical indications including changes to the lesion over time with respect to itching, bleeding, pain, active inflammation, recurrent infection requiring antibiotics, or recurrent trauma will be funded by the CCG subject to prior approval on an individual basis


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Port wine stains on the face will be funded for removal. Port wine stains on other parts of the body that are causing physical discomfort or are resulting in tissue hypertrophy should be funded Treatment should be considered for other haemangiomatous or vascular lesions should be funded if:

There are physical problems such as bleeding or ulceration

The lesion is on the face and is unusually prominent and is getting bigger

Evidence that previous treatment has been pursued before referral has been made will be required. The threshold for agreeing funding will be lower in patients under the age of 19 years







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Policy statement: Blepharoplasty


In all cases photography will be required for the individual prior approval

Blepharoplasty (upper and lower lid) will only be funded to correct functional impairment (and not purely for cosmetic reasons).

Blepharoplasty will be offered for one or more of the following indications:

A. Excess eyelid tissue (Dermatochalasis) causing functional visual impairment

AND

Documented complaints of interference with vision or visual field-related activities such as difficulty reading or driving due to upper eyelid skin drooping, looking through the eyelashes or seeing the upper eyelid skin.

AND

Photographic evidence must show redundant skin overhanging the upper eyelid margin and resting on the upper eyelashes when gazing straight ahead. (NOTE: excess tissue below the eye rarely causes functional visual impairment and therefore lower lid blepharoplasty is not funded for this indication)

B. Rehabilitation of eyelids affected by the pathological processes of thyroid eye

disease, nerve palsy or blepharochalasis

AND

Causing either functional visual impairment (complaints of interference with vision or visual field-related activities such as difficulty reading or driving due to upper eyelid skin drooping, looking through the eyelashes or seeing the upper eyelid skin) or corneal exposure/irritation

C. To correct prosthesis difficulties in an ophthalmic socket

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Page 22 of 152

NOTE: Photographs must be taken from the front with the camera at eye level and the individual looking straight ahead (primary gaze). Relevant OPCS codes:

C13 1

EXCISION OF REDUNDANT SKIN OF EYELID

BLEPHAROPLASTY OF BOTH EYELIDS

C13 2


BLEPHAROPLASTY OF UPPER EYELID

C13 3


BLEPHAROPLASTY OF LOWER EYELID

C13 4


BLEPHAROPLASTY NEC

C13 8


OTHER SPECIFIED

C13 9


UNSPECIFIED

Background:

Blepharoplasty is a surgical procedure to remove excess skin and fatty tissue from either the upper or lower eyelid. It can be done either on its own or in combination with a ptosis repair of the eyelid muscles or brow muscles (to correct drooping of the eyelids or brow). A blepharoplasty can be performed for both cosmetic and functional purposes. West Essex CCG will NOT fund blepharoplasty for cosmetic reasons.

Dermatochalasis refers to an excess of eyelid tissue (skin and underlying muscle, connective tissue and fat can also all be excessive). It is usually due to the ageing process and can therefore be considered as normal. However where the excess eyelid skin interferes with vision and causes a functional impairment this can warrant treatment. Surgical removal of these overhanging skin folds may improve the function of the upper eyelid and restore peripheral vision. Photographic evidence submitted should demonstrate excess upper eyelid tissue overhanging the upper eyelid margin and resting on the upper eyelashes (photographs taken from the front with the camera at eye level and the individual looking straight ahead).

Although Dermatochalasis is most often due to the ageing process, the excess eyelid tissue may result from specific disorders, such as thyroid eye disease or blepharochalasis (an inflammatory eye condition) which cause stretching of the eyelid skin. In these instances the excess upper eyelid skin should interfere with vision causing a functional impairment or excess lower eyelid skin should cause corneal exposure and irritation.

Nerve palsy can predispose to corneal exposure and irritation through abnormal relaxation of the upper and lower eyelids causing lagophthalmos (inability to fully close the eye) and paralytic ectropion (eversion of the lower eyelid).


Page 23 of 152

Visual field testing is not necessary to determine the presence of excess upper eyelid skin, a patient could cause a visual field defect by lowering their lids during the test. Photographs that document redundant skin overhanging the upper eyelid margin and resting on the upper eyelashes when gazing straight ahead provide a practical indication of the need for surgery. If visual field tests are performed, the tests should show that eyelids impinge on visual fields reducing field to 120° laterally and 40° vertically.

References:

Cahill,K.V., Bradley,E.A., Meyer,D.R., et al. (2011) Functional Indications for Upper Eyelid Ptosis and Blepharoplasty Surgery : A Report by the American Academy of Ophthalmology. Ophthalmology. 118(12): 2510-2517

Ho,S.F., Morawski,A., Sampath,R., Burns,J. (2011) Modified visual field test for ptosis surgery (Leicester Peripheral Field Test). Eye. 25:365–369

Rahman,I. and Sadiq,S. (2007) Ophthalmic management of facial nerve palsy: A review. Survey of Ophthalmology. 52(2): 121-144.

Nerad,J. (2009) Techniques in ophthalmic plastic surgery. Elsevier: London

Koursh,D., Modjtahedi,S., Selva,D. and Leibovitch I. (2009) The blepharochalasis syndrome. Survey of ophthalmology. 54(2):235-44




Health and Care Commissioning Committee

Date approved: May 2014

Produced by (Title): Clinical Commissioner

Review date: April 2016

http://www.ncbi.nlm.nih.gov/pubmed?term=Koursh%20DM%5BAuthor%5D&cauthor=true&cauthor_uid=19298902

http://www.ncbi.nlm.nih.gov/pubmed?term=Koursh%20DM%5BAuthor%5D&cauthor=true&cauthor_uid=19298902

http://www.ncbi.nlm.nih.gov/pubmed?term=Modjtahedi%20SP%5BAuthor%5D&cauthor=true&cauthor_uid=19298902

http://www.ncbi.nlm.nih.gov/pubmed?term=Modjtahedi%20SP%5BAuthor%5D&cauthor=true&cauthor_uid=19298902

http://www.ncbi.nlm.nih.gov/pubmed?term=Leibovitch%20I%5BAuthor%5D&cauthor=true&cauthor_uid=19298902


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Policy statement: Bobath Therapy


Policy:

This policy specifies the criteria for referral of children with cerebral palsy to the

Bobath Centre in London. Referrals are to be considered by the multidisciplinary

team caring for the child, led by the Consultant Community Paediatrician. The policy

advocates that children fulfilling one or more of the listed criteria should be

considered for referral.

Children with cerebral palsy, requiring multidisciplinary therapeutic input, can be

considered for referral for Bobath therapy. These would include:

Severe, complex cerebral palsy

Ataxia cerebral palsy

Athetoid cerebral palsy

Children with severe feeding difficulties

Dystonic and hypertonic cerebral palsy

These children are to be assessed for the need for, and potential to benefit from

Bobath therapy, prior to referral. The Consultant Community Paediatrician leading

the child's care will be responsible for the medical assessment, the co-ordination of

the multi-disciplinary assessments the referral for funding.

The referral should indicate:

The severity and complexity of the condition

Details of multiple impairment

Benefits of referral in general and in relation to the age of the child

Need for multi-disciplinary input and why local services are unable to meet the

needs of the child

Commitment of local services and the parents to support the Bobath training


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Parental understanding/involvement and ability to carry out Bobath programme at

home

The referral documents must include a report from the Bobath centre on the

suitability of the child for assessment and the costings for this.

The panel should inform the referrer and the Children’s Commissioner of its decision.

Definition: Please see Bobath Centre leaflet on therapy services and tariff








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Policy Statement: Breast Asymmetry


Funding will only be considered if there is gross disparity of breast cup sizes i.e.

asymmetry where there is at least 2 cup size difference in breast size on initial

consultation with the patient’s GP. The goal of surgery is to correct a significant

deformity. Contour irregularities and moderate asymmetry (including dog-ears,

nipple direction or position, breast size and shape disparity) are predictable following

surgery. Any post-surgical cosmetic irregularities will not be funded by the CCG in

revision surgery.

Patients are eligible for surgery to correct breast asymmetry if all the following

criteria are met and confirmed by a consultant plastic surgeon:

There is a natural absence of breast tissue unilaterally where there is no

ability to maintain a normal breast shape using non-surgical methods (e.g.

padded bra), and

There is a difference of at least 2 cup sizes (e.g. C and DD cup size

differential), and

Patient Aged ≥ 18 years old and has reached end of puberty (referral should

be delayed if end of puberty has not been reached), and

Where relevant, treatment of the underlying cause of the problem has been

undertaken and

The patient has a BMI<25 and evidence that the patient’s weight has been

stable for 2 years.

The choice of surgical intervention (i.e. unilateral breast reduction or unilateral breast

augmentation) should be made jointly by the person and the clinician and taking into

account:

The experience of the surgeon who will perform the operation, and

The best available evidence on effectiveness and long term effects, and

The facilities and equipment available, and

Significant musculoskeletal pain/functional problems


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Patient must be aged at least 18 years. Surgery for patients aged 16 or 17 years will

only be funded if breast size has been stable for at least one year, and the referring

clinician can satisfy the clinical review group that it is unreasonable to wait until the

patient is 18 years old.

All patients who are smokers should be referred to smoking cessation

services at the initial assessment appointment

Please refer also to the cosmetic surgery general principles prior to submitting

an exceptional funding request.








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Policy statement: Breast Augmentation – Clinical (including revision

and replacement)


Breast implants may be funded for the following clinical indications:

Amastia (complete absence of breast tissue)

Reconstructive Surgery following mastectomy (see Breast Reconstruction below)

Chest cavity wall deformity

Insertion of breast implants is not otherwise commissioned.

Removal and replacement of breast implants: There are instances for clinical

indications where breast implants will need to be removed and replaced.

These include when the following indications are met:

Original procedure was provided by the NHS; and

Implant is proven to be ruptured.

The removal and replacement of breast implants is not otherwise commissioned.




patient is 18 years old.










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Policy statement: Breast Augmentation – Cosmetic (including revision

and replacement)

Status: Not Normally Funded

Insertion of breast implants is not commissioned.

All other breast augmentation surgery is regarded as a procedure of low priority and is only funded on an exceptional basis. Prior to submitting an application, please be aware of the section below “Cosmetic Surgery General Principles” paragraph 5 for the CCG’s commissioning position on seeking funding for cosmetic surgery on Mental Health/Psychological Grounds.

Where patients are assessed by clinicians to meet the criteria, prior approval to treat is not required from the CCG. Where patients do not meet the criteria, approval must be obtained from the CCG prior to treatment.

Removal and replacement of breast implants:

There are instances for clinical indications where breast implants will need to be removed and replaced.

These include when the following indications are met: Original procedure was provided by the NHS (e.g. as part of treatment for breast cancer), and

Implant is proven to be ruptured.

The removal and replacement of breast implants is not otherwise commissioned.

Removal of privately funded breast implants:

The removal of privately funded breast implants, both unilaterally and bilaterally, is commissioned where there is a clinical reason requiring removal, such as the implant is proven to be ruptured. Patients will be offered the choice of removing both prostheses in the event that only one has been ruptured with the intention of ensuring symmetry.


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The replacement of privately funded breast implants, either unilaterally or bilaterally, where removal is required is not commissioned. Replacement with privately purchased prostheses is not allowed alongside NHS removal of ruptured implants. Patient must be aged at least 18 years. Surgery for patients aged 16 or 17 years will only be funded if breast size has been stable for at least one year, and the referring clinician can satisfy the clinical review group that it is unreasonable to wait until the patient is 18 years old.

All patients who are smokers should be referred to smoking cessation services at the initial assessment appointment




Acute Transformation Delivery Board





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Policy statement: Breast Reconstruction

Status: Threshold

Breast reconstruction surgery, including the insertion of implants, is

commissioned for reconstructive surgery following mastectomy;

Where patients are assessed by clinicians to meet the criteria, prior approval to treat

is not required from the CCG.

Removal and replacement of breast implants:

There are instances for clinical indications where breast implants will need to be

removed and replaced.

These include when both of the following indications are met:

Original procedure was provided by the NHS (e.g. as part of treatment for breast cancer), and

Implant is proven to be ruptured. The removal and replacement of breast implants is not otherwise commissioned.




patient is 18.


services at the initial assessment appointment.








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Policy statement: Breast Reduction


Breast reduction surgery is regarded as a procedure of a low clinical priority. Cosmetic breast surgery (surgery undertaken exclusively to improve appearance) is not normally provided to correct natural changes such as those associated with pregnancy or ageing. This procedure is therefore not routinely funded by the CCG. The goal of surgery is primarily functional and not cosmetic. Contour irregularities and moderate asymmetry (including dog-ears, nipple direction or position and breast size disparity) are predictable following surgery. Any post-surgical cosmetic irregularities will not be funded by the CCG for revision surgery.

Breast reduction surgery is funded on a restricted basis only. GPs and Consultants must obtain prior approval before proceeding.

Breast reduction surgery is an effective intervention that should be funded if one of the following sets of criteria is met:

SET 1:

The patient is suffering from neck ache or backache. Clinical evidence will need to be produced to rule out any other medical/physical problems to cause these symptoms; and the wearing of a professionally fitted brassiere has not relieved the symptoms, and

Full evidence is provided of all conservative management options that have been attempted and

The patient has a BMI < 25 and evidence that the weight has been stable for 2 years, and

The patient has persistent intertrigo for at least one year and confirmed by GP OR another serious functional impairment for at least one year

SET 2:

The patient is male with hormonal or drug related breast growth (Please see Gynaecomastia)

SET 3: Pubertal hyperplasia


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A reduction can be performed if it is expected that at least 500g will be removed from each breast. If this is not clinically appropriate, funding will not be available. Patients who have predictable breast changes due to pregnancy are excluded. Patients should have an initial assessment by the referrer prior to an appointment with a consultant plastic surgeon to ensure that these criteria are met. At, or following this assessment, there should be access to a trained bra fitter, to assess if this alone will relieve the symptoms experienced by the patient. Assessment of the thorax should be performed, including the use of x-ray, scan etc.

All patients who are smokers should be referred to smoking cessation services at the initial assessment appointment.








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Policy statement: Bunion Surgery

Status: Threshold

The term Bunion refers to any enlargement or deformity of the 1st MTP joint,

including enlarged bursae, overlying ganglion, gouty arthropathy, and hallux vagus,

as well as bony masses that can develop secondary arthritis. They also often cause

marked lesser toe deformities.

The surgical treatment of asymptomatic bunions is regarded as a procedure of low clinical priority. These procedures are, therefore, not routinely funded.

Requests for the removal of bunions will only be considered where

conservative methods of management* have failed, AND

the patient suffers significant functional impairment** as a result of the bunions, AND

radiographic evidence of joint damage (at point of referral) *Conservative measures include:

Avoiding high heel shoes and wearing wide fitting leather shoes

Non-surgical treatments such as bunion pads, splints, insoles or shields or exercise where appropriate

**Significant functional impairment is defined as:

The patient complains of moderate to severe joint pain not relieved by

extended non-surgical management AND has severe impact on their ability to undertake activities of daily living.

Concerns about cosmetic appearance should be managed by the patient or Primary Care and not referred into secondary care or a Community Podiatric service. Detailed documentation against the criteria that are fulfilled is mandatory in the referral letter to secondary care. Clinically inappropriate referrals will be returned to GPs. Follow up will be capped at one follow up unless there are exceptional circumstances


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Policy statement: Surgery for Carpal Tunnel Syndrome

Status: Threshold

Policy: The CCG will fund Carpal Tunnel Surgery where:

Symptoms persist after conservative therapy of: nocturnal splinting, local corticosteroid injections and physiotherapy. Or

There is neurological deficit, for example sensory blunting, muscle wasting or weakness or thenar abduction.

AND

Severe symptoms significantly interfere with daily activities.

Definition: Carpal Tunnel Syndrome is a condition characterised by attacks of pain and tingling in the first

three or four fingers of one or both hands, which usually occurs at night. It is caused by

pressure on the median nerve as it passes under the strong ligament that lies across the front of

the wrist.

Rationale: Conservative treatment offers short-term benefit (1-3 months) similar to surgery and many

patients’ symptoms may resolve for at least a year after conservative treatment. After

corticosteroid injection, up to 50% of patients may report minor or no symptoms at one year.

The benefits of conservative therapy are seen early after treatment and then decrease while the benefits of surgery take longer to be fully realised.

Corticosteroid injections and nocturnal splinting are effective conservative therapies. Therefore patients would not normally be referred for carpal tunnel syndrome unless they have had a local steroid injection into the carpal tunnel together with the provision of night splints. Electro-diagnostic tests are not indicated in the diagnosis of classical carpal tunnel syndrome. These may be done where there is doubt about the diagnosis, which is uncommon.

In the longer term (3-18 months), surgery is better than conservative therapy with up to 90% of patients reporting complete or much improvement at 18 months.

trial of conservative therapy offers the opportunity to avoid surgery for some patients.


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Evidence: Local corticosteroid injection is effective in relieving symptoms, but effectiveness beyond one

month is uncertain. Local injection is more effective than oral steroids (Cochrane Review,

Search Date May 2002).

Some studies suggest up to 80% effectiveness (no or minor symptoms) at one month which decreases to 50% at one year for corticosteroid injection (Dammers et al) compared with placebo.

Non-surgical treatment, including oral steroids, splinting, ultrasound, yoga and carpal bone

mobilisation show short-term benefit compared with placebo or other non-surgical control

interventions (Cochrane Review, Search Date March 2002).

Surgery is better than splinting at relieving symptoms at three months and one year (Cochrane Review, Search Date October 2002).

Two recent randomised controlled trials compared surgery to injected steroids. One (n=50) showed greater symptomatic improvement with surgery at 20 weeks. The other (n=163) showed greater improvement in the steroid group for nocturnal paraesthesiae at three months but equivalence at six and twelve months. In the second study, most patients needed two steroid injections and referral to surgery was counted as treatment failure in the intention to treat analysis (Hui 2005, Ly-Pen 2005).

One recent randomised controlled trial compared splinting to surgery. This study, included in the Cochrane review, showed improved outcomes with surgery at three months and 18 months (Gerritsen 2002). By 18 months, 41% of the splinting group had undergone surgery.

Two randomised controlled trials have compared steroid injections with splinting. In one study in mild to moderate carpal tunnel syndrome, at one year, splinting was effective for both symptoms and nerve conduction when worn every night. Steroid injection was not effective at one year (Sevim 2004). The other study (Celiker 2002) compared non-steroidal anti-inflammatory agents and splinting to steroid injection. Both groups showed similar improvement at eight weeks.

Risk of nerve damage is low for most patients and the relationship between symptoms and nerve conduction study results is not good.

Smoking status of all patients undergoing procedures in secondary care: Patients should be aware that their smoking status may need to be determined if they are being

referred to secondary care for treatment. The CCG recommends that patients are non-smoking

for a minimum period of 8 weeks prior to any surgical operation taking place, especially if under

general anesthetic. Patients should be made aware that there is strong evidence that smokers

are more likely to have lung, heart and infectious complications and remain in hospital longer

after their operation. Support is available through the Health Promotion Team to help patients

who wish to stop smoking.

BMI: All non-urgent patients with a BMI above 30 should be offered advice and support by their GP to

help them lose weight. The patient should be reassessed after 3 months and a clinical decision


Page 38 of 152

taken whether to refer them for surgery or to continue with weight reduction.

References 1. Ly-Pen D, Andreu JL, de Blas G, Sanchez-Olaso A, Millan I. Surgical decompression

versus local steroid injection in carpal tunnel syndrome: a one-year, prospective, randomised, open, controlled clinical trial. Arthritis Rheum 2005;52: 612-9.

2. J W H H Dammers, M M Veering, and M Vermeulen, Injection with methylprednisolone proximal to the carpal tunnel: randomised double blind trial BMJ 1999 319: 884-886.

3. A.C.F. Hui, S. Wong, C. H. Leung, P. Tong, V. Mok, D. Poon, C. W. Li-Tsang, L. K. Wong, and R. Boet A randomised controlled trial of surgery vs steroid injection for carpal tunnel syndrome Neurology, June 28, 2005; 64(12): 2074 - 2078.

4. Marshall S, Tardif G, Ashworth N. Local corticosteroid injection for carpal tunnel syndrome. The Cochrane Database of Systematic Reviews 2002, Issue 4.

5. O'Connor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) for carpal tunnel syndrome. The Cochrane Database of Systematic Reviews 2003, Issue 1.

6. Verdugo RJ, Salinas RS, Castillo J, Cea JG. Surgical versus non-surgical treatment for carpal tunnel syndrome. The Cochrane Database of Systematic Reviews 2003, Issue 3.

7. Sevim S, Dogu O, Camdeviren H, Kaleagasi H, Aral M, Arslan E, Milcan. A Long-term effectiveness of steroid injections and splinting in mild and moderate carpal tunnel syndrome. Neurol Sci. 2004 Jun;25(2):48-52.

8. Gerritsen AA, de Vet HC, Scholten RJ, Bertelsmann FW, de Krom MC, Bouter LM. Splinting vs surgery in the treatment of carpal tunnel syndrome: a randomised controlled trial. JAMA 2002 Sep 11;288(10):1245-51.

9. Celiker R, Arslan S, Inanici F. Corticosteroid injection vs nonsteroidal anti-inflammatory drug and splinting in carpal tunnel syndrome. Am J Phys Med Rehabil. 2002 Mar;81(3):182-6.

10. Thoseby M, Commissioning Information Manager, Anglia Support Partnership; January 2007; Updated Clinical Thresholds Analysis.

11. Black’s Medical Dictionary. 40th Edition. A & C Black. London 2002.

Glossary11

Nocturnal splinting: A support worn on the hand at night.

Neurological: Conditions affecting the nervous system.

Placebo: Inactive substance - often used in clinical trials. Also has the ability to relieve

a variety of symptoms.

Thenar: The thenar eminence is the body of muscle on the palm of the human hand

just beneath the thumb.

Paraesthesiae: Unusual feelings, apart from mere increase, or loss of sensation, experienced

by a patient without any external cause.


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Policy statement: Cataracts

Status: Threshold

Referrals should not be based simply on the presence of a cataract. Referral of patients with cataracts to ophthalmologists should be based upon the two following indications: A Impairment of lifestyle (not exhaustive list) such as;

the patient is at significant risk of falls, or

the patient’s vision is affecting their ability to drive, or

the patient’s vision is substantially affecting their ability to work, or

the patient’s vision is substantially affecting their ability to undertake leisure activities such as reading, watching television or recognising faces or

management of other co- existing eye conditions AND

B Willingness to have cataract surgery: The referring optometrist or GP should discuss the risks and benefits using an approved information leaflet (national or locally agreed) and ensured that the patient understands and is willing to undergo surgery before referring.

Second eye As the benefits of second eye surgery have been demonstrated patients will be offered second eye surgery provided they fulfil the referral criteria. Second eye surgery should be deemed urgent when there is resultant anisometropia (a large refractive difference between the two eyes of 2 ½ dioptas) which would result in poor binocular vision or diplopia (this should be clearly recorded in the patient’s notes). The reasons why the patient’s vision and lifestyle are adversely affected by cataract and the likely benefit from surgery must be documented in the clinical records. Providers will be audited on the indications for cataract surgery. Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed as per the CCG policy.




Date approved: 20th

June 2014




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Policy statement: Chronic Fatigue Syndrome/Myalgic

Encephalomyelitis (CFS/ME)


Policy:

Referral for a specialist opinion may be required if there is doubt about the diagnosis,

or the patient is not improving despite management in primary care. There is limited

high quality evidence relating to the effectiveness of interventions in CFS. The Chief

Medical Officers Independent Working Group on CFS/ME identified three potentially

beneficial approaches to managing CFS:

Graded exercise therapy

Cognitive behavioural therapy

Pacing

Funding for inpatient care will not be funded. Patients should be diagnosed and

managed in a community setting.

Definition (from Chief Medical Officer’s Independent Working Group on

CFS/ME – Annex 6 – January 2002):

“Chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) is now generally

accepted as being a discrete disorder or spectrum of disorders. This condition

may also be known as post-viral or post-infections fatigue syndrome. Some

believe that ME is separate from CFS, but little evidence currently exists to support

this decision”. Concerns remain over the name given to the condition, but while

awaiting review of the terminology, this clinical policy refers to the disorder as

CFS/ME, in line with the report of the Chief Medical Officer’s Independent Working

Group.

CFS/ME is a debilitating disorder characterised by profound tiredness or fatigue.

Patients may become exhausted with only light physical exertion. They most often

function at a level of activity substantially lower than their capacity before the onset

of illness. In addition to these key defining characteristics, patients generally

support various non-specific symptoms, including weakness, muscle aches and

pains, excessive sleep, malaise, fever, sore throat, tender lymph nodes, impaired


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memory and/or mental concentration, insomnia and depression. The report of the Chief Medical Officer’s Independent Working Group states that

the majority of the treatment and care of people with CFS/ME should be

undertaken by primary and community services, with referral through to local

secondary care specialist services when appropriate. Treatment and follow up

following assessment should be provided locally.

Resource Implications: This policy does not change current practice; therefore, the resource implications

remain unchanged.

Background: A total of 38 randomised control trials (RCTs) have been investigated seven

different categories of intervention: behavioural, immunological, antiviral,

pharmacological, supplements, complementary/alternative and multi-treatment.

Overall, interventions demonstrated mixed results in terms of effectiveness. All

conclusions about effectiveness should be considered together with the

methodological inadequacies in some of the studies.

The report of the Chief Medical Officer’s Independent Working Group and the

Effective Healthcare Bulletin volume 7, No 4, 2002 highlighted that there is

evidence from randomised controlled trials for cognitive behavioural therapy (CBT)

and graded exercise therapy (GET). Further research is required to evaluate the

effectiveness of pacing (an energy management strategy in which patients are

encouraged to achieve an appropriate balance between rest and activity).

GLOSSARY

Cognitive-behavioural

therapy

Is a type of psychological treatment where the

therapist attempts to clarify with the patient specific

features of behavioural or mental outlook and

identify step-by-step methods the patient can use

for controlling the disorder.

Fibromyalgia: A syndrome with symptoms that vary, with pain and

fatigability generally prominent.

Malaise: Feeling unwell and/or tired.

Lymph nodes: Part of the immune system.

Insomnia: Sleep difficulties.

Immunological treatment: Treatment to modify the immune response of an


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individual.

Serological variables: Results of blood tests.

References:

1. Sutton G, Camillerie-Ferrante C. Chronic Fatigue Syndrome: Epidemiology, Aetiology and Treatment. ACET, Institute of Public Health, University of Cambridge, 1996.

2. Price JR Coouper J. Cognitive Behaviour Therapy for Adults with Chronic Fatigue Syndrome. Systematic Review: The Cochrane Library, Issue No 3 2000, Oxford: Update Software Abstract available from: www.update- software.com/abstracts/ab001027.htm

3. Holmes G et al. Chronic Fatigue Syndrome: A Working Case Definition. Annals of Internal Medicine, 108 387-389, 1998.

4. Lawrie SM, Pelosi AJ. Chronic Fatigue Syndrome in the Community: Prevalence and Associations. British Journal of Psychiatry, 166 (6), 793-7, 1995.

5. Wessely S et al. Post-infections Fatigue: Prospective Cohort Study in Primary Care. Lancet, 345 (8961): 1333-8, 1995.

6. Best L Stevens A. Cognitive behavioural therapy in the treatment of chronic fatigue syndrome. DEC Report No 50, Development and Evaluation Committee, R & D Directorate South & West, 1996. www.hta.nhsweb.uk/rapidhta/

7. Wilson A et al. Longitudinal Study of Outcome of Chronic Fatigue Syndrom. BMJ, 308, 756-9,1994. www.bmj.com/cgi/content/full/308/6931/756

8. Hickie I et al. Chronic Fatigue Syndrome: Current Perspectives on Evaluation and Management. Medical Journal of Australia, 163 (6), 314-18, 1995

9. Black’s Medical Dictionary. 40th Edition. A & C Black, London 2002. 10. A Report of the CFS/ME Independent Working Group to the Chief Medical

Officers – January 2002. www.doh.gov.uk/cmo/cfsmereport 11. Effective Healthcare Bulletin volume 7 No 4 2002.

www.york.ac.uk/inst/crd/ehc74.pdf




Date approved: 20th

June 2013



http://www.update-software.com/abstracts/ab001027.htm

http://www.update-software.com/abstracts/ab001027.htm

http://www.hta.nhsweb.uk/rapidhta/

http://www.hta.nhsweb.uk/rapidhta/

http://www.bmj.com/cgi/content/full/308/6931/756

http://www.doh.gov.uk/cmo/cfsmereport

http://www.york.ac.uk/inst/crd/ehc74.pdf

http://www.york.ac.uk/inst/crd/ehc74.pdf


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Policy statement: Circumcision

Status: Threshold

Policy:

Circumcision is considered a low priority treatment and will only be provided for

therapeutic reasons in line with these guidelines:

Phimosis (inability to retract the foreskin due to a narrow prepucial ring) in children with spraying, ballooning and/or recurrent infection

Adult phimoisis

Recurrent balanitis, balantitis xertotica obliterans (chronic inflammation leading to a rigid fibrous foreskin)

Paraphimosis ((inability to pull forward a retracted foreskin)

Suspicion or evidence of malignancy, dermatological disease (such as lichen planus or eczema) which is unresponsive to other treatment, where biopsy is required and occasionally for selected patients with urinary tract infections (normally referred by a paediatrician)

Balanoposthis (recurrent bacterial infection of the prepuce)

Definition:

Circumcision is a surgical procedure to remove the foreskin of the penis.

There are several alternatives to treating retraction difficulties before circumcision

is carried out. It is important that all those performing circumcision should follow

the General Medical Council (GMC) guidelines.

Resource implications: This policy does not change current practice; therefore, the resource implications

remain unchanged. Circumcision for religious or social reasons is not funded in

any circumstances.

Risks: Haemorrhage and infection are well-recognised complications. In addition, in the

long-term, problems such as psychological trauma and possible decreased sexual


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pleasure have been reported.

GLOSSARY: (ref 6)

Foreskin: Penile Cancer:

Prepuce:

(see prepuce). cancer of the penis.

Is the free fold of skin that overlaps the glans penis and retracts

when the penis becomes erect. It is the part that is removed at

circumcision.

REFERENCES: 1. Davenport M (1996). ABC of General Surgery in Children: Problems with the

Penis and Prepuce. BMJ 1996; 312:299-301. http://www.bmj.com/cgi/content/full/312/7026/299

2. Frisch M et al. (1995). Falling Incidence of Penis Cancer in an Uncircumcised Population (Denmark 1943-90). BMJ 1995; 311:1471. http://www.bmj.com/cgi/content/full/311/7018/1471

3. General Medical Council. Guidance for doctors who asked to circumcise male children (September 1997). www.gmc-uk.org/n hance/good/circum.htm

4. Norm-UK. Clinical Guidelines: the management of phimosis October 1999. http://www.norm-uk.co.uk/clinicalquide.htm

5. Szabo R et al. Education and Debate, How Does Male Circumcision Protect Against HIV Infection? BMJ 2000, 320: 1592 – 1594 (10 June). http://www.bmj.com/cgi/content/full/320/7249/1592

6. Black’s Medical Dictionary. 40th Edition. A & C Black. London. 2002.











http://www.gmc-uk.org/n%20hance/good/circum.htm

http://www.norm-uk.co.uk/clinicalquide.htm

http://www.norm-uk.co.uk/clinicalquide.htm




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Policy statement: Complementary and Alternative Therapies


Policy:

Complementary and alternative therapies are a mixed group of therapies considered

low priority treatments on the basis of weak evidence of clinical effectiveness. They

will only be provided under the NHS as part of an existing service where:

The individual therapy used for a specific condition has been critically appraised and has been shown to have proven clinical effectiveness

The training and practice of the therapist is regulated by a statutory regulatory body.

Definition:

Complementary and alternative therapies comprise a wide range of disciplines.

We have adapted the classification recently used by the House of Lords Select

Committee, which divides these therapies into three groups:

Group 1- those which are regarded as the principle disciplines:

o Group1a – with statutory regulatory control – osteopathy, chiropractic o Group 1b – acupuncture, herbal medicine and homeopathy

Group 2 - therapies used to complement conventional medicine without embracing diagnostic skills, e.g. massage, aromatherapy, hypnotherapy, reflexology and the Alexander Technique

Group 3 - therapies which are long established and rational in certain cultures (e.g. Ayurvedic medicine)

o Group 3b – others with no credible evidence such as crystal therapy and dowsing.

Whilst some evidence of effectiveness exists for therapies in Group 1, the clinical

effectiveness of the majority of these therapies has not been proved with strong

evidence as obtained through properly established scientific trials. Some NHS

professionals use a selection of these therapies in their practice, e.g.


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physiotherapists using manipulation or acupuncture, or GP’s using homeopathy.

With effective regulatory mechanisms in place for individual professionals and

under NHS clinical governance arrangements use of such therapies is acceptable.

Resource implications: This policy does not change current practice; therefore, the resource implications

remain unchanged

Health Benefits: While some complementary treatments may give health benefits, these have

proved difficult to quantify. A placebo effect can lead people (both patients and

therapists) to conclude that a treatment is effective when it is not. This is true for

new treatments in scientific medicine as well as for complementary and alternative

medicine.

This is why new scientific treatments are subject to experimental trials and the

evidence of effectiveness is critically appraised. There is little good quality

evidence comparing alternative therapies with other treatments, and this makes it

particularly difficult to judge the health benefit of the therapy.

Risks: In general, these are likely to be low, but should not be ignored. Adverse reactions

to herbal medicines can be due to toxic compounds, interaction with conventional

drug treatments, heavy metals or corticosteroids in the preparation as well as the

herbs themselves. Infections linked to acupuncture and the improper handling of

needles or their reuse, without sterilisation, has included Hepatitis B and C, HIV,

bacterial endocarditis and staphylococcal septicaemia. It is accepted that these

are rare events, but they highlight the need for therapies to be used by properly

trained and accredited professionals in a controlled environment.

Regulatory framework: National developments such as the relatively recent creation of General

Osteopathy and General Chiropractic Councils will help establish accreditation and

quality standards for professionals in Group 1a as defined by the House of Lords

Report.

Priority: Due to low evidence of effectiveness, complimentary therapies will only be funded

in exceptional circumstances and where they are incorporated into mainstream

NHS practice.


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GLOSSARY

Acupuncture

Endocarditis

Homeopathy

Placebo effect

Septicaemia

Where fine sterile needles are inserted into the skin at specific

points on the body Inflammation of the lining of the heart cavity and valves

An alternative approach to medicine based upon the theory that

diseases are curable by those drugs which produce effects on the

body similar to symptoms caused by the disease.

A medicine that is ineffective but may help to relive a condition

because the patient has faith in its powers. New drugs are tested

against placebos in clinical trials.

Widespread destruction of tissues due to absorption of disease-

causing bacterial or their toxins from the bloodstream. The term is

also used loosely for any form of ‘blood poisoning’.

REFERENCES: 1. Complementary and alternative medicine. Report of the House of Lords Select

Committee on Science and technology: Session 1999-2000. HL Paper 123. London: The stationery Office; 2000.

2. Oxford Concise Colour Medical Dictionary. New Third Edition. Oxford University Press. 2002.







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Policy statement: Correction of privately funded treatments


Policy:

Correction of privately funded treatments which are causing clinical problems for the patient should be considered on a case by case basis by the CCG exceptions panel.

Definition:

This policy covers any privately funded treatment for which funding is sought to

correct or revise the treatment on the NHS.

Rationale: The increase in privately funded surgery has led to an increase in requests for

correction or amendments of such surgery on the NHS. Referrals should be

considered by the CCG to and will only be funded where there is a clinical need.

Referral Criteria: Corrections or revisions of privately funded treatments will only be considered for

funding if there is a clinical need, or a clinical risk to the patient. Corrections or

revisions for cosmetic reasons will not be funded. Corrections or revisions for

implants or procedures such as breast implants or bariatric surgery will only

consider removal and not replacement unless the patient meets the current criteria

listed within the relevant service restriction policy.

Smoking status of all patients undergoing procedures in secondary care: Patients should be aware that their smoking status may need to be determined if

they are being referred to secondary care for treatment. The CCG recommends

that patients are non-smoking for a minimum period of 8 weeks prior to any

surgical operation taking place, especially if under general anaesthetic. Patients

should be made aware that there is strong evidence that smokers are more likely

to have lung, heart and infectious complications and remain in hospital longer after

their operation. Support is available through the Health Promotion Team to help

patients who wish to stop smoking.


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Policy statement: Cosmetic Surgery General Principles

Status: Individual Prior Approval (unless covered by an

alternative policy)

Referrals for plastic surgery from both primary and tertiary sources will be assessed in line with the Service Restriction Policy and the clinical evidence provided.

For an authorised first appointment, the Plastic Surgery Specialist to whom the referral is subsequently passed should decide whether the patient would benefit from plastic surgical intervention, and if so, establish that the patient fully understands the risks and benefits of surgery.

All referrals should be assessed for both first OPD appointments and subsequent procedure appointments, in line with the policy and clinical evidence.

Cosmetic surgery undertaken exclusively to improve appearance should not be funded in adults, in the absence of previous trauma, disease or congenital deformity.

The clinical effectiveness of cosmetic surgery to treat symptoms such as depression and anxiety was reviewed by the Mental Health and Learning Disabilities Programme Board in December 2013. The Board agreed the position that it could not support commissioning cosmetic interventions as a result of mental health presentations due to insufficient evidence to support the effectiveness of the intervention in terms of treating mental health conditions. Such referrals will only be reviewed on an exceptional cases basis.

Assessment of patients being considered for referral who have an underlying genetic or endocrine etc reasons should have had this fully investigated by a relevant specialist prior to the referral to plastic surgery being made.

Surgery should be supported where a patient has been accepted onto an NHS waiting list prior to taking up residence in West Essex, providing the existing clinical evidence has remained the same.

Referrals within the NHS for the revision of treatments originally performed outside the NHS will not usually be permitted unless the patient meets the local criteria for the original treatment. Referrers should be encouraged to re-refer to the practitioner who carried out the original treatment for resolution first where not endangering the health of the individual.


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Where a patient has previously had NHS funded treatment, procedures necessary for dealing with complications or an outcome that, because of complications or technical difficulties, has resulted in cosmetic or physical problems that, from a professional point of view, are severe enough to oblige the NHS to fund corrective treatment, should be supported.

Revision surgery will not be funded for purely aesthetic reasons.

The National Service Framework for Children (National Service Framework for Children, Young People and Maternity Services (DH October 2004)), defines childhood as ending at 19 years. Funding for this age group should only be considered if there is a problem likely to impair normal emotional development. Children under the age of five rarely experience teasing and referrals may reflect concerns expressed by the parents rather than the child, which should be taken into consideration prior to referral. Some patients are only able to seek correction surgery once they are in control of their own healthcare decisions and again this should be taken into consideration prior to referral.





Produced by (Title): Public Health Specialist



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BACK TO INDEX

Policy statement: Cosmetic Surgery on mental health grounds


Referrals will only be reviewed on an exceptional cases basis.

The clinical effectiveness of cosmetic surgery to treat symptoms such as depression and anxiety was reviewed by the Mental Health and Learning Disabilities Programme Board in December 2013. The Board agreed the position that it could not support commissioning cosmetic interventions as a result of mental health presentations.

Rationale: The Institute of Education (2013) carried out a systematic review of research into cosmetic procedures on the request of the Department of Health and found as part of their research that patients who had cosmetic surgery were found to be significantly more likely to suffer from psychological issues such as depression and in particular Body Dysmorphic Disorder (BDD). The study indicated that cosmetic surgery often did not improve the conditions and in some cases made it worse. Psychological and medical treatments such as anti-depressants or CBT were shown to be more effective at reducing depression and other mental health problems in those with BDD. A study by Tilmann Von Soest (2012), focused on females, also concluded that a series of mental health problems predict cosmetic surgery, but cosmetic surgery does not in turn seem to alleviate such mental health problems.

References:

1) Psychosocial predictors, assessment and outcomes of cosmetic interventions,

Brunton G et al, (2013), Institute of Education London.

2) Predictors of cosmetic surgery and its effects on psychological factors and mental health: a population-based follow-up study among Norwegian females Soest, Tilmann M. von; Kvalem, I. Lundin; Wichstrøm, L. (2012) Psychological Medicine, 42(3):617-626



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Produced by (Title); Public Health Specialist


BACK TO INDEX

Policy statement: Dilatation and Curettage/Hysteroscopy

Status: Threshold

D&C and hysteroscopy will only be used in line with NICE guidance (CG44, 2007) Patients will undergo hysteroscopy in the investigation and management of heavy menstrual bleeding only when it is carried out:

as an investigation for structural and histological abnormalities where ultrasound has been used as a first line diagnostic tool and where the outcomes are inconclusive, for example to determine the exact location of a fibroid or the exact nature of the abnormality;

where dilatation is required for non-hysteroscopic ablative procedures, hysteroscopy should be considered immediately prior to the ablative procedure to ensure correct placement of the device (unless pre-operative ultrasound assessment has already been undertaken).

Patients will not receive D&C:

as a diagnostic tool for heavy menstrual bleeding; or

as a therapeutic treatment for heavy menstrual bleeding.

Postmenopausal women who have had a pelvic scan and endometrial biopsy and who present with further bleeding 6 months later should be offered hysteroscopy to be sure no small cancer has been missed without a mandatory preliminary scan. Hysteroscopy for the majority of women can normally be performed as an outpatient procedure.




Date approved: 21st

March 2013


Review date: By March 2015


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BACK TO INDEX

Policy statement: Endoscopic Laser Spinal Surgery


Endoscopic laser spinal surgery for chronic back pain is of unproven benefit.

Referral and treatment should only be considered under exceptional

circumstances, in settings which meet the requirements of NICE guidance

(IPG027, IPG031, IPG061 and IPG088).

Definition:

Chronic back pain is a common condition, responsible for considerable morbidity

among the population. In general, all appropriate therapies for this condition

should be supplied by providers within West Essex.

Endoscopic spinal laser surgery is done on prolapsed intervertebral discs and

other spinal conditions using minimally invasive laser techniques such as laser

lumbar discectomoy and endoscopic laser foraminoplasty.

Criteria:

The only indications for this spinal surgery to be considered are those from NICE

guidance (IPG027, IPG031, IPG061, IPG088, IPG081) and must conform to this

guidance i.e. should not be used without special arrangements for audit consent

and research.

IPG061 Percutaneous endoscopic laser thoracic disectomy is used to treat symptomatic thoracic disc hemiation

IPG027 Laser lumbar disectomy considered when there is nerve compression or persistent symptoms that are unresponsive to conservative treatment. Laser disectomy can be performed when the prolapse is contained. It is one of several minimally invasive surgical techniques which are alternatives to open repair procedures such as open lumbar disectomy or laminectomy.


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IPG031 Endoscopic laser foraminoplasty for chronic back and leg pain from a variety of causes

IPG088 Endoscopic division of epidural adhesions for lower back pain, particularly when radiculopathy (a disorder of the spinal nerve roots) is present

IPG981 Percutaneous intradiscal electrothermal therapy for discogenic back pain

Patients should have a BMI of between 20kg/m2 and 27kg/m2. Evidence will be

required that the patient’s weight has been stable for a period of not less than

two years.




surgical operation taking place, especially if under general anesthetic. Patients


to have lung, heart and infectious complications and remain in hospital longer

after their operation. Support is available through the Health Promotion Team to

help patients who wish to stop smoking.

Estimated number of people affected: Low back pain affects 70% of people at some point in their lives, and chronic

back pain Is the commonest cause of disability in the developed world, affecting

an estimated 2.7% of adults. Endoscopic laser spinal surgery is used for those

with extensive previous back treatments that have failed (“failed back

syndrome”).

Resource implications: This policy does not change current practice; therefore,

the resource implications remain unchanged.

Health benefits: The evidence for the effectiveness of the intervention is currently poor. Recent

NICE guidance IPG027 states that “current evidence on the safety and efficacy

of laser lumbar discectomy does not appear adequate to support the use of this

procedure without special arrangements for consent and for audit or research”.

This was also the conclusion for endoscopic laser foraminoplasty (IPG031),

percutaneous endoscopic laser thoracic discectomy (IPG061) and endoscopic

division of epidural adhesions (IPG088). Referrals to out of area providers for

this treatment will not be supported except in exceptional circumstances.

Risks: The risks of any type of spinal surgery are well recognised. Risks of


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endoscopic laser spinal surgery, in particular, can include possible high rates of

subsequent open surgery, infection and unnecessary surgery. This means that it

is essential that the possible benefits of any such procedure are demonstrated

clearly before becoming part of routine practice.

GLOSSARY:

Endoscopic:

Laser:

Using a tube-shaped instrument inserted into a body cavity to

investigate and treat disorders. An abbreviation for Light Amplification by Stimulated

Emission of Radiation. Produces a light with a very high level

of energy, which can be focussed on a small spot, e.g. to

make an incision.

REFERENCES: 7. Fairbank J. The incidence of back pain in Britain. In: Hukins, D,

Mulholland R (eds) Back pain. Methods for clinical investigation and assessment. Manchester University Press, 1986.

8. Boult M et al. Percutaneous Endoscopic Laser Discectomy. Australian & New Zealand Journal of Surgery. 70(7):475-9, 2000 Jul.

9. Knight ML et al. Endoscopic laser foraminoplasty on the lumbar spine – early experience. Minimally Invasive Neurosurgery. 41(1):5-9, 1998 Mar.

10. National Institute for Clinical Excellence. IPG027 Laser Llumbar discectomy, guidance. December 2003.

11. National Institute for Clinical Excellence. IPG031 Endoscopic laser foraminoplasty, guidance. December 2003.

12. National Institute for Clinical Excellence. IPG061 Percutaneous endoscopic laser thoracic discectomy, guidance. May 2004.

13. National Institute for Clinical Excellence. IPG088 Endoscopic division of epidural adhesions, guidance. September 2004.








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Policy statement: Exogen for non-union or delayed healing of long

bone fractures

Status: Individual Prior approval

Recommendation Exogen may be funded under the following circumstances: Fractures of long bone fractures with non-union (failure to heal 9 months after fracture), where surgery is otherwise the option, if:

fracture gap is ≤ 1 cm, AND non-union is not related/secondary to malignancy, AND non-union confirmed by 2 radiographs minimum 90 days apart and

physician statement of no clinical evidence of fracture healing For the purposes of this evaluation, long bone fractures are defined as fractures of the humerus, ulna, radius, femur, tibia and fibula.

If the fracture is unstable or inter-fragment gap >1 cm then surgery is the expected option.

Exogen will NOT be funded for: Delayed healing (no radiological evidence of healing between 3 and 9 months)

Additional information needed Date of fracture Dates of radiography confirming non-union and no further progression towards radiographic healing

For the purposes of exceptionality, the cohort is defined as: Non-union fracture of long bone, where surgery is otherwise an option, and where fracture is stable, aligned and inter fragment gap is <1cm.

Rationale NICE Medical Technology Guidance 12 http://guidance.nice.org.uk/MTG12/Guidance/pdf/English

The NICE Committee recognised that the available clinical data on the effectiveness of EXOGEN for treating long bone fractures with non-union show high rates of fracture healing and it judged them sufficient to support the efficacy and utility of Exogen treatment. Despite the absence of direct evidence on

http://guidance.nice.org.uk/MTG12/Guidance/pdf/English


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avoiding surgery, the Committee considered that the assumptions in the cost model were plausible and that Exogen is cost saving compared with current management for the treatment of non-union. Overall, therefore, the case for adoption of Exogen in the treatment of long bone fractures with non-union was found to be supported by the evidence.

For long bone fractures with delayed healing the Committee considered that the clinical evidence was more limited. In addition there were significant uncertainties about the rate at which healing progresses between 3 and 9 months after fracture, both with and without Exogen, and about whether or not surgery would be required if Exogen was not used. These and other considerations influenced the Committee's views about the most appropriate assumptions for cost modelling: the model considered to be most appropriate estimated that Exogen treatment would be more costly than current management. The Committee therefore judged that the case for adoption of Exogen to treat long bone fractures with delayed healing was not supported by the current evidence.

There is some evidence that use of Exogen is cost saving compared to surgery; should surgery not be an option then use of Exogen is likely to be a cost pressure.

Uncertainties: Evidence is from observational studies which are weaker sources of evidence Variation in fracture healing time among patients which could account for some of the findings Selection criteria for treatment with Exogen is unclear No direct studies to prove outcomes compared with do nothing or surgery Outcomes were based on healing rates rather than weight bearing or return to normal daily living

NICE costing implications 1% of females and 1.6% males >18 years incidence of long bone fracture 7.5% of fractures do not heal, of which 21.4% non union at 9 months 50% stable, aligned and inter fragment gap <1cm – suitable for Exogen Per 100,000 standard population Exogen would be offered to ~8 patients per annum ~£5k savings from Exogen instead of surgery under the above assumptions



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BACK TO INDEX

Policy statement: Face Lifts and Brow Lifts (Rhytidectomy)


These procedures will be considered for treatment of:

Congenital face abnormalities

Facial palsy (congenital or acquired paralysis)

As part of the treatment of specific conditions affecting the facial skin e.g. cutis laxa, pseudoxanthoma elasticum, neurofibromatosis

To correct the consequences of trauma

To correct deformity following surgery

They will not be available to treat the natural processes of ageing.

Please refer also to the cosmetic surgery general principles prior to

submitting an exceptional funding request.








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Policy statement: Facet Joint Injections for lower back pain


Policy:

Referral to a hospital consultant for Facet Joint Injections for lower back pain are

considered low priority, and will only be provided under the NHS in line with the

guidance below.

Definition:

A facet joint injection is an injection of local anaesthetic and steroid either directly

into the joint or to the path of the small nerve which supplies sensation to the

joint. The injection will test whether the pain is actually arising from the joint or

nerve itself, and whether the pain would respond to a longer-lasting procedure to

stun the nerve supplying the joint.

Specifically this policy relates to the following injections:

Epidural

Facet joints (intra-articular, peri-articular, nerve blocks)

Local trigger points

Rationale:

Facet joints are considered to be a common source of chronic spinal pain. Facet joint interventions, including intraarticular injections (with anaesthetics and/or steroids), medial branch nerve blocks, and neurotomy (radiofrequency and cryoneurolysis) are used to manage chronic facet-mediated spinal pain. The limited research available on this treatment suggests that injections are not

likely to reduce pain or make the patient more flexible. Furthermore facet joint

and lumbar epidural injections have rare, but serious adverse effects, such as

pain at injection site, infection, haemorrhage, chemical meningitis and possible


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damage to the nervous system.

Referral Criteria:

Whatever benefit is only moderate, if at all, and only limited long term benefit.

There is no evidence that injection therapy is of any use in back pain. Injection of

facet joints may sometimes aid diagnosis in back pain. Such cases should be

approved by the CCG’s exceptions panel. It is recognised that for a small number of patients facet joint and epidural

injections can produce a longer term solution. However, such cases will be

exceptional and at the discretion of the CCG’s exceptions Panel.

Patients may be entitled to repeat injections only where previous injections have

provided at least 6 months pain relief.






to have lung, heart and infectious complications and remain in hospital longer

after their operation. Support is available through the Health Promotion Team to

help patients who wish to stop smoking.

REFERENCES: 1. Injection therapy for subacute and chronic low-back pain. J Bart Staal,

Rob de Bie, Henrica CW de Vet, Jan Hildebrandt, Patty Nelemans – 2007.

2. Therapeutic facet joint interventions in chronic spinal pain: a systematic review of effectiveness and complications Boswell M V, Colson J D, Spillane W F. 2005

3. NICE CG 88

4. Low back pain: an evaluation of therapeutic interventions. Evans G, Richards S.

5. Chronic Low back pain. Maurits van tulder. 2006

6. Low Back Pain. Cathy Speed. ARC 2003

7. Epidural steroids in the management of chronic spinal pain : a systematic


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review. Abdi S, Datta S, Trescot A M, Schultz D M, Adlaka R, Atluri S L, Smith Hs, Manchikanti L. 2007

8. The basis for recommending repeating epidural steroid injections for radicular low back pain : a literature review. Novak & Nemeth. 2008.

9. BMJ evidence

10. Overtreating chronic back pain : Time to back off?. Deyo R A, Mirza S K, Turner J A, Martin B I

11. European Guidelines for the Management of Acute and Chronic Non- Specific Low Back Pain.

12. Airaksinen O etal – European Spine Journal. 2006

13. American Pain Society. May 2008








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Policy Statement: Functional Electrical Stimulation


Recommendation Functional electrical stimulation (FES) is not routinely funded for drop foot of central neurological origin.

For patients already being treated, who will require ongoing funding for maintenance and support, prior approval will be required and the following criteria apply: The patient will have objectively demonstrated (using validated tools) that the use of FES is still clinically appropriate, e.g. by • foot drop which impedes gait and evidence that this is not satisfactorily controlled using ankle–foot orthoses • gait improvement from its use.

FES is not routinely funded for other indications unless explicitly indicated.

Additional information needed For ongoing funding – evidence of the two criteria listed above.

For the purposes of exceptionality, the cohort is defined as: People with drop foot of neurological origin (including stroke, multiple sclerosis and spinal cord injury) impeding gait not satisfactorily controlled using ankle–foot orthoses

Rationale Whilst NICE IPG 2878 concluded adequate evidence of effectiveness the studies are small and methodologically weak and whilst they suggest an effect on walking speed the significance of this for patient quality of life eg falls prevention is uncertain. The Scottish Intercollegiate Guidelines Network (SIGN 2010) concluded insufficient good quality evidence to support or refute use of FES.

East Midlands Specialised Commissioning Group (2013) undertook an update of the evidence and concluded that overall the literature relating to the use of FES is of moderate quality and on balance there is stronger evidence to suggest that


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FES is not more effective that currently available alternative treatments. Only the East Midlands review assessed the cost effectiveness of FES.

Compared with the usual treatment option (ankle foot orthosis) there is little difference between interventions with no data report on cost comparisons.

Estimates of the prevalence and incidence of foot drop in the UK caused by neurological deficits are difficult to find due to the range of neurological disorders causing upper neurone lesions and variability in the symptom, often not reported.

In consideration of stroke rehabilitation and falls prevention agenda in West Essex, FES has not been raised for consideration in local pathways.

Acknowledgements http://www.leicestercity.nhs.uk/Library/EMSCGPolicyFESEOupdated3March11_3 _V1D3.pdf NICE IPG 278 (2009) Functional Electrical Stimulation for drop foot of central neurological origin http://publications.nice.org.uk/functional-electrical-stimulation-for-drop-foot-of- central-neurological-origin-ipg278 http://www.cambsphn.nhs.uk/Libraries/Lower_Clinical_Priority_Policies/V1_FES_ DEC13_1.sflb.ashx






Produced by (Title); Consultant in Public Health


http://www.leicestercity.nhs.uk/Library/EMSCGPolicyFESEOupdated3March11_3_V1D3.pdf

http://www.leicestercity.nhs.uk/Library/EMSCGPolicyFESEOupdated3March11_3_V1D3.pdf

http://publications.nice.org.uk/functional-electrical-stimulation-for-drop-foot-of-central-neurological-origin-ipg278

http://publications.nice.org.uk/functional-electrical-stimulation-for-drop-foot-of-central-neurological-origin-ipg278

http://www.cambsphn.nhs.uk/Libraries/Lower_Clinical_Priority_Policies/V1_FES_DEC13_1.sflb.ashx

http://www.cambsphn.nhs.uk/Libraries/Lower_Clinical_Priority_Policies/V1_FES_DEC13_1.sflb.ashx


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Treatment threshold Asymptomatic gallbladder stones will not be approved for treatment. - This is in patients who have a normal gallbladder and normal biliary tree. - The patient will have had stones diagnosed incidentally and had no symptoms from

the stones within the previous 12 months prior to being diagnosed (NICE 2014). If symptoms develop, the patient will be treated by the correct clinical pathway. Exceptions to the treatment threshold include the following groups where treatment will be considered (Behari and Kapoor, 2012);

o People with diagnosed chronic haemolytic syndromes o People with an increased risk of developing gallbladder cancer o Immunosuppressed patients who would be at a greater risk of infective

complications o Others deemed at an increased risk of complication (as confirmed by a

secondary care clinician) Stones found within the common bile duct should be treated. This includes both symptomatic and asymptomatic patients (see NICE guideline CG188). Condition - Gallstones are hard deposits that form within the gallbladder. - The gallbladder is a small structure that sits behind the liver on the left side of the

body. It holds bile. Bile is made in the liver. - The bile moves from the liver to the gallbladder via small tube like structures called

ducts. - It is estimated that up to 15% of people have gallstones in the UK (NICE 2014).

Most people will experience no symptoms from them. - Often they will be diagnosed during tests including ultrasounds or scans for other

health problems. - Treatment options commonly include drug therapy, ultrasound treatment or surgery

that removes the gallbladder. This surgery is called a cholecystectomy. Rationale - NICE guidelines (CG188) published in October 2014 recommend that people with

asymptomatic gallstones should not receive treatment. This is in people who have a normal gallbladder and normal biliary tree.

Policy statement: Asymptomatic gallbladder stones

Status: Threshold


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- They should receive reassurance about their condition rather than have treatment. - They may receive treatment if they develop symptoms. - 80% of people with gallbladder stones will not develop symptoms (NICE 2014). - There are exclusions to the threshold. These groups should be considered for

treatment due to the co-morbidities that exist and the complications that could develop if they do not receive treatment (Behari and Kapoor, 2012).

- Common bile duct stones should be treated regardless of symptoms. This is due to

the complications that can develop if they are left (NICE, 2014). Evidence (NICE 2014 CG188) - The evidence reviewed for the NICE guidelines was insufficient. The

recommendations are largely based on the panel’s experience and judgement. - From the review that was carried out on the question ‘what strategies should be

used to treat asymptomatic gallbladder stones?’ no evidence could be found. - The recommendations on treatment were made from the experiences of the panel. - Cholecystectomy (the surgical removal of the gallbladder) is a common treatment.

Although successful because it removes the gallbladder and stone content, the risks of surgery including general anaesthetic were thought to outweigh benefits of surgery.

- Overall, treatments were not thought to benefit the patient nor be an effective use of NHS resources.

Additional searches for evidence did not find further information to dispute NICE guidelines. Equality Impact Assessment has been completed and submitted for review. References NICE (2014) NICE guidelines (CG188) Gallstone Disease (Full guidance). www.nice.org.uk Kapoor A and Behari V.K. (2012) Asymptomatic gallstones (AsGs); to treat or not to treat? Indian Journal of Surgery 2012 Feb; 74 (1): 4-12 Accessed April 2015 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3259178/ NICE (2014) NICE guidance costing statement (CG188) www.nice.org.uk Glossary Gallbladder; this is a pouch that sits on the left side of the body near the liver. Common bile duct; this is a channel like structure that is the main duct between the liver and gallbladder. Gallstones; these are small stones that form within the gallbladder. Most of these stones are made up of cholesterol or pigment. Common bile duct stones; these are stones that have moved from the gallbladder into the common bile duct. Cholecystectomy; surgical removal of the gallbladder.

http://www.nice.org.uk/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3259178/

http://www.nice.org.uk/


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West Essex Health and Care Committee

Date approved: April 2015



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Policy statement: Grommets (with or without Adenoidectomy)

Status: Threshold

The CCG will only agree to fund treatment with Grommets for children under 12 years old with bilateral otitis media with effusion (OME) under the following circumstances: There has been a period of 3 months watchful waiting from the date of the first appointment with an audiologist AND OME persists after 3 months and the child suffers from at least one of the following:

At least 5 recurrences of acute otitis media in a year

Evidenced delay in speech development

Hearing level in the better ear of 25-30 dBHL or worse averaged at 0.5, 1, 2, & 4 KHZ (or equivalent dBH where dBHL not available)

Hearing loss of less than 25-30 dBHL where the impact on a child’s development, social or educational status is judged to be significant*

A second disability such as Down’s syndrome or cleft palate OR OME is overlaying sensorineural deafness or is delaying diagnosis or treatment with aids or cochlear implants (this would be an indication for immediate grommets). *Evidence from GP or Community Healthcare professional that symptoms prevent the child from carrying out vital educational activities or symptoms prevent the child from carrying out other vital activities. Requirements for approval Two sets of hearing results through audiologist assessment three months apart. Documented evidence of the impact of hearing loss on the child’s development as defined above. All other reasons for grommets in children are not funded.




Date approved: 21st March 2013




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Policy statement: Gynaecomastia (including revision surgery)


All men have breast tissue and a breast bud. This policy intends to provide treatment for extreme/severe breast contour resulting from true breast development. This policy excludes treatment for excess skin folds in the breast following weight loss. True gynaecomastia is benign enlargement of male breast tissue. It can be defined as the presence of >2cm palpable, firm, subareolar gland and ductal tissue (not fat). True gynaecomastia will be funded (i.e. true breast tissue is present not just adipose tissue – pseudogynaecomastia). The clinician should ensure that the following are confirmed:

Breast cancer has been ruled out

Testicular cancer has been ruled out

Underlying endocrine or liver abnormality has been ruled out

The condition is not due to the abuse of drugs with bodybuilding

The condition is not a side effect of medication or drugs e.g. spironolactone, cimedtidine, digoxin or cannabis.

Surgery to correct unilateral or bilateral gynaecomastia should be allowed if the patient:

Is post pubertal (stable height for past 6 months) AND

Has BMI < 25 kg/m2 with evidence that the patient’s weight has been stable for 2 years AND Has breast enlargement on at least one side which is Grade III or above using Cordova’s classification system (see appendix) OR has unilateral breast enlargement with a difference of at least 2 grades (e.g. normal and Grade II differential).

Scarring, contour irregularities and moderate asymmetry (including dog-ears, nipple direction or position, breast size and shape disparity) are predictable following surgery. Any post-surgical cosmetic irregularities will not be funded by the CCG in revision surgery. Applications must include at least 2 colour photographs of the chest. Photographs should go from the top of the chest down to the umbilicus. One should be taken from directly in front of the patient and another at an angle of 45 degrees (see the attached classification photos, Grades II – IV, for examples).



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Appendix 1. Cordova and Moschella Classification1

Grade I No submammory fold

Grade II Nipple-areolar complex above the fold

Grade III Nipple-areolar complex same level as fold

Grade IV Nipple-areolar complex under the fold

1. 1 Cordova, A., & Moschella, F. (2008). Algorithm for clinical evaluation and surgical

treatment of gynaecomastia. Journal of plastic, reconstructive & aesthetic surgery : JPRAS, 61(1), 41–9. doi:10.1016/j.bjps.2007.09.033


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Grade I

Grade II

Grade III Grade IV

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Produced by (Title): Public Health Registrar

Review date: By June 2015


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Policy statement: Hair Loss


Alopecia – funding will be considered when it is a result of previous surgery or

trauma including burns.

Male pattern baldness is low priority.

Hair transplantation is low priority.










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Policy statement: Hernias – Referral Guidance

Status: Guidance

Definition: A hernia is the protrusion and subsequent displacement of a viscus through an orifice or a weakness in the wall of the cavity in which it is contained. There are several types of herniae:

Inguinal hernias These occur above the inguinal ligament and are the most

common type of hernia. Every year in England, 70,000 surgical operations are required to repair inguinal hernias. 98% occur in men and are commoner as one gets older. Approximately 63,000 primary hernia repairs and 5,000 repairs of recurrent inguinal herniae take place annually. 5% of primary repairs and 9% of recurrent repairs are done as emergencies for complications of hernia. 30% of people with a unilateral hernia develop one on the opposite side.

Femoral hernias These also occur in the groin but below the inguinal ligament. They occur in 16 out of every 100,000 people in England and 75% occur in females.

Incisional hernias These develop as a complication of abdominal surgery, due to consequent weakness in the muscles of the abdominal wall. Incisional hernia develops in 0.5-10% of patients after abdominal surgery.

Umbilical hernias These are very common in young children, with one in six children being affected. Black children are 10 times more likely to develop an umbilical hernia than white children. The reasons for this are unclear. In most cases, an umbilical hernia will resolve as a child grows older, without the need for treatment.

Hernias are very common and in many cases cause very few or no symptoms. However a hernia could cause intestinal obstruction or strangulation of the bowel, both of which are medical emergencies.

General Guidelines: A direct hernia with a wide neck, and hence a smaller risk of complications, may be managed conservatively by observation and review, especially if the patient is elderly and treatment is a surgical risk. However herniae with a narrow neck or that are symptomatic should be referred directly for surgical assessment.

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Clinical examination will generally suffice in the diagnosis of a hernia Repair to umbilical herniae is generally considered unnecessary. Incisional herniae that are symptomatic may need surgical repair

Smoking cessation is specifically important in the management of patients with hernias as a chronic cough will cause/worsen a hernia.

Only requests for surgical support for asymptomatic wide necked herniae should, in the first instance be referred to the Special Cases Panel of the CCG. Date: 01.04.2011 Review date: 01.04.2013

REFERENCES:

European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. M. P. Simons, T. Aufenacker, M. Bay-Nielsen, J. L. Bouillot, G.Campanelli, J. Conze, D. de Lange, R. Fortelny, T. Heikkinen, A. Kingsnorth, J. Kukleta, S. Morales-Conde, P. Nordin, V. Schumpelick, S. Smedberg, M. Smietanski, G.Weber, and M. Miserez . Hernia. 2009 August; 13(4): 343–403.

Map of Medicine

Laparoscopic surgery for inguinal hernia repair: systematic review of effectiveness and economic evaluation. K McCormack, B Wake, J Perez, C Fraser, J Cook, E McIntosh, L Vale, A Grant. Health Technol Assess 2005;9(14):1–218

Open or endoscopic total extraperitoneal inguinal hernia repair? A systematic review. Kuhry E, van Veen RN, Langeveld HR, Steyerberg EW, Jeekel J, Bonjer HJ. Surg Endosc. 2007 Feb;21(2):161-6

NICE TA 083; Sept 2004

SSAT 2005

A cost-utility analysis of treatment options for inguinal hernia in 1,513,008 adult patients. Stylopoulos N, Gazelle G S, Rattner D W. Surgical Endoscopy and Other Interventional Techniques 2003; 17(2): 180-189; NHS Economic Evaluation Database (NHS EED)

Laparoscopic techniques versus open techniques for inguinal hernia repair McComack K, Scott N, Go PM, Ross SJ, Grant A, Collaboration the EU Hernia Trialists. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database of Systematic Reviews 2003, Issue 1. Art. No.: CD001785. DOI:

Koninger J, Redecke J, Butters M. Chronic pain after hernia repair: a randomised trial comparing Shouldice, Lichtenstein and TAPP. Langenbecks Arch Surg. 2004; 389(5):361-5.



West Essex Clinical Commissioning Executive




http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Kuhry%20E%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus



http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Langeveld%20HR%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Langeveld%20HR%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Jeekel%20J%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Jeekel%20J%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus


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Policy statement: Primary Total Hip Replacement Surgery: Non-Acute

Status: Threshold

Policy:

The most common indication for elective primary total hip replacement (THR) is

degenerative arthritis (osteoarthritis) of the joint, other indications include

rheumatoid arthritis, injury, bone tumour and necrosis of the hip bone.

The aims of THR are relief of pain and improvement in function1. THR can be very

successful for the appropriate patients. More than 90% of people who undergo

these operations will never need revision surgery.

The CCG will agree to fund referrals and surgery, under prior approval, where the

patient meets the following criteria.

Referral criteria for routine referral to orthopaedic services* (refer to Table 1

for referral criteria definitions) based on RAND appropriateness methodology

developed by Jose Quintana and colleagues9,10.

Candidates for elective THR should have:

Moderate to severe persistent pain not adequately relieved by an extended course of non-surgical management. • AND clinically significant functional limitation resulting in diminished quality of life. • AND radiographic evidence of joint damage.

Guidance for secondary care on thresholds for hip replacement surgery. Evidence suggests that the following groups of patients would benefit from hip joint

replacement surgery9,10.

1. When the patient complains of: a. Severe joint pain.

b. AND has severe functional limitation irrespective of whether or not there has


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been a trial of conservative management. c. OR has minor to moderate functional limitation, despite the use of non-surgical

treatments such as adequate doses of non-steroidal anti-inflammatory drug

(NSAID) analgesia, weight control management and physical therapies.

OR 2. Where the patient complains of: a. Mild to moderate joint pain.

AND has severe functional limitation, despite the use of non-surgical treatments

such as adequate doses of NSAID analgesia, weight control treatments and

physical therapies.

AND is assessed to be at low surgical risk.

Referral criteria definitions:

Variable Definition

Pain level

Mild Pain interferes minimally on an intermittent basis with usual daily activities. Not related to rest or sleep. Pain controlled by one or more of the following: NSAIDs with nor or tolerable side effects, aspirin at regular doses, paracetamol.

Moderate Pain occurs daily with movement and interferes with usual daily activities. Vigorous activities cannot be performed. Not related to rest or sleep. Pain controlled by one or more of the following: NSAIDs with nor or tolerable side effects, aspirin at regular doses, paracetamol.

Severe Pain is constant and interferes with most activities of daily living. Pain at rest or interferes with sleep. Pain not controlled, even by narcotic analgesics.

Previous non-surgical interventions

Correctly done NSAIDs, paracetamol, aspirin or narcotics analgesics at regular doses during 6 months with no pain relief; weight control management if overweight, physical therapies done.

Incorrectly done NSAIDs, paracetamol, aspirin or narcotics analgesics at inadequate doses or less than 6 months with no pain relief; or no weight control management if overweight (community weight reduction service will be available from April 2011), or no physical therapies done.


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Functional limitations

Minor Functional capacity adequate to conduct normal activities and self care. Walking capacity of more than one hour. No aids needed.

Moderate Functional capacity adequate to perform only a few or none of the normal activities and self care. Walking capacity of about one half hour. Aids such as a cane are needed.

Severe Largely or wholly incapacitated. Walking capacity of less than half hour, or unable to walk or bedridden. Aids such as a cane, a walker or a wheelchair required.

Definition:

Relevant OPCS(s):

W37 – Total prosthetic replacement of hip joint using cement.

W38 – Total replacement of hip joint not using cement.

W39 – Other total replacement of hip joint.

Rationale: A small number of patients experience complications following elective total hip

replacement, and for this reason patients should not be considered for joint

replacement until their condition has become chronic and conservative

management has failed.

Guidance to Primary Care on the Treatment of Hip Pain due to Osteoarthritis The Musculoskeletal Services Framework from the Department of Health (DH) and

guidance from NICE, the GP Training Network and the National Institute of Health

(NIH) Consensus Panel suggests that:

Management of common musculoskeletal problems, including hip pain, in primary care is ideal.

Primary care practitioners need direct access to therapy, walking aids, dietetic and health promotion services.

Primary care management should seek to maximise the benefits of surgery and minimise complications when surgery is necessary.

The initial non-surgical management of hip pain due to OA should provide a

package of care that may include weight reduction (community weight reduction

service will be available from April 2011), activity modification, adequate doses of

NSAIDs and analgesics, introducing walking aids, other forms of physical

therapies.

Contraindications There are few absolute contradictions for THR other than active local or systemic


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infections and other medical conditions that substantially increase the risk of serious peri-operative complications or death. Severe peripheral vascular disease and some neurological impairment are both relative contraindications to THR. Advanced age and obesity (BMI 30-39.9) are not a contra-indication to surgery.




surgical operation taking place, especially if under general anaesthetic. Patients





GLOSSARY

BMI Body Mass Index provides an objective assessment of

whether a person is at a healthy weight in relation to

height, to enable an estimation to be made of an

individual’s risk of mortality or morbidity. The BMI is

calculated by dividing the person’s weight in kilograms

by their height in metres squared

References: 1. National Institute of Clinical Excellence. Primary care referral guidelines for common conditions. NICE 2003; London. 2. The Musculoskeletal Services Framework – A joint responsibility: doing it differently. Department of Health, 2006. 3. Lübbeke A, Stern R, Garavaglia G, Zurcher L and Hoffmeyer P. Differences in outcomes of obese women and men undergoing primary total hip arthroplasty. Arthritis and Rheumatism, 2007; 57: 327-334. 4. National Institute of Clinical Excellence and National Collaborating Centre for Primary Care. Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children. NICE December 2006; London. 5. Azodi OS, Bellocco R, Eriksson K and Adami J. The impact of tobacco use and body mass index on the length of stay in hospital and the risk of post-operative complications among patients undergoing total hip replacement. Journal of Bone and Joint Surgery British, 2006; 88: 1316-1320. 6. Furlong C. Preoperative Smoking Cessation: A model to Estimate Potential Short Term Health Gain and Reductions in Length of Stay. A Report by the London Health Observatory, 2005. 7. Patel VP, Walsh M, Sehgak B, Preston C, DeWal H and Di Cesare PE. Factors associated with prolonged wound drainage after primary total hip and knee arthroplasty. Journal of Bone and Joint Surgery American, 2007; 89: 33-38.


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8. NICE. Guidance on the use of metal on metal hip resurfacing arthroplasty. Technology Appraisal Guidance No 44, 2002. 9. Quintana JM, Arostegui I, Azkarate J, Goenaga I, Elexpe X, Letona J and Arcelay A. Evaluation of explicit criteria for total hip replacement. Journal of Clinical Epidemiology, 2000; 53: 1200-1208. 10. Quintana JM, Escobar A, Arostegui I, Bilbao A, Azkarate J, Goenaga I and Arenaza J. Health related quality of life and appropriateness of knee or hip joint replacement. Archives of Internal Medicine, 2006; 166: 220-226. 11. Dawson J, Fitzpatrick R, Fletcher J and Wilson R. Osteoarthritis Affecting the Hip and Knee. In Health Care Needs Assessment: The epidemiologically based needs assessment reviews, Second Edition, Volume 1. Editors; Stevens A, Raftery J, Mant J and Simpson S. Radcliff, 2004; Radcliffe Publishing Oxford and San Francisco. 12. Bedfordshire and Hertfordshire Priorities Forum Statement Number 32: Referral criteria for patients from primary care presenting with hip pain due to osteoarthritis and clinical thresholds for elective primary hip replacement surgery, February 2007.





Produced by (Title): Public Health Consultant



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BACK TO INDEX

Policy statement: Hip Arthroscopy

Status: Threshold

Arthroscopy of the hip can be carried out for the following:

Sepsis of the Hip Joint (Septic arthritis /Infectious arthritis) – Hip arthroscopy is supported in the washout of an infected native hip joint in patients who are resistant to medical management; patients with underlying diseases; or patients who are immunosuppressed

Loose Bodies – Hip arthroscopy is supported for the removal of radiologically proven loose bodies within the hip joint

Excision of Radiological Proven Labral Tears in the Absence of Osteoarthritis or Femoro-Acetabular Impingement Syndrome (FAI) – Hip arthroscopy is supported for the excision of radiological proven labral tears associated with an acute traumatic episode in the absence of osteoarthritis or FAI syndrome.

Arthroscopy of the hip should NOT be used for the following:

Femoro-Acetabular Impingement Syndrome (also known as Hip Impingement Syndrome)

Any other indication or pathologies

Rationale: In March 2012 the East Midlands Specialist Commissioning Group

produced a comprehensive policy on Arthroscopy of the Hip1. This looked at the

evidence behind all the listed treatments.

Sepsis of the Hip Joint – This usually arises in elderly people or very young children.

Whilst incidence is said to be uncommon, mortality is high. In 2011 Draper2 states

‘surgical drainage may be required in any infected joint which does not respond to

medical treatment, although the decision as to whether to use a repeated needle

aspirations or arthroscopic lavage is chiefly anecdotal and not supported by a large

comparative evidence base. Patients with underlying disease, such as rheumatoid

arthritis and diabetes, or are immune-suppressed, benefit from earlier surgical

intervention’.

Without the option of arthroscopy, surgical intervention would be more formal and

recovery would be hampered not only by the condition, but the operation itself.


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Despite a lack of comprehensive research evidence, arthroscopic washout is

considered an option.

Loose Bodies – Physiotherapy or conservative treatment will not relieve the pain

symptoms of radiologically proven loose bodies in the hip joint as it is a mechanical

problem. In the absence of arthroscopy a more formal and extensive arthrotomy

(larger incision) is required. Recovery is then hampered by the initial problem, but

also as a result of the operation itself.1

Excision of Radiological Proven Labral Tears in the Absence of Osteoarthritis or

Femoro-Acetabular Impingement Syndrome (FAI) – One systematic review (Schmerl

2005)3 found that the short-term results of arthroscopic debridement of labral tears

have been favourable. However, one study they identified found that after two years

those with minor tears reported excellent results, but the more severe tears did not

fair as well. Arthroscopy may be beneficial for the short- term relief of symptomatic

labral tears, however longer term consequences are unknown.

Femoro-Acetabular Impingement Syndrome (also known as Hip Impingement

Syndrome) –

At the time East Midlands were writing their policy the IPG 213, 2007 was under

review. This has now been replaced by IPG 408 (2011). The IP overview 365 (June

2011) again noted a number of concerns regarding the validity and generalisability of

the studies they considered when making their recommendations for IPG 408.

East Midlands reported that there had been other reviews in 2005, 2008 which had

concluded that there is insufficient evidence to support the use of hip arthroscopy.

Three systematic reviews in 2009 & 10 (Longo, 2010, Stevens, 2010 and Baldwin,

2010) were all cautious and recommended that issues needed to be addressed.

From these Stevens did suggest that the level of evidence is higher for FIA than for

other indications, but agrees that the ‘higher –quality trials (Level I and II) are needed

to provide support for the increasing application of this surgical technique’

Based on the available evidence there is still an absence of reliable information

about health gain over the medium and long term, the associated costs and

complete information about the risks of treatment, therefore at the present time FIA

will not be included in the policy.

Note: Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed as per the CCG policy.

References:

1) East of Midlands Specialised Commissioning Group, Policy: Arthroscopy of

the Hip, 2012


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http://www.emscg.nhs.uk/Library/EMSCGP047V1HipArthroscopyallpathologie sFINALAug2012.pdf

2) Draper R. Septic Arthritis. Patient UK, 2011. www.patient.co.uk/doctor/spetic- arthritis.htm

3) Schmeri M, Pollard H, Hoskins W. Labral Injuries of the Hip: A Review of Diagnosis and Management. Journal of Manipulative and Physiological Therapeutics, 2005 p632

4) Arthroscopic femoro-acetabular surgery for hip impingement syndrome (IPG408, 2011) http://publications.nice.org.uk/arthroscopic-femoroacetabular- surgery-for-hip-impingement-syndrome-ipg408




Date approved: June 2014



http://www.emscg.nhs.uk/Library/EMSCGP047V1HipArthroscopyallpathologiesFINALAug2012.pdf

http://www.emscg.nhs.uk/Library/EMSCGP047V1HipArthroscopyallpathologiesFINALAug2012.pdf

http://www.patient.co.uk/doctor/spetic-arthritis.htm

http://www.patient.co.uk/doctor/spetic-arthritis.htm

http://publications.nice.org.uk/arthroscopic-femoroacetabular-surgery-for-hip-impingement-syndrome-ipg408

http://publications.nice.org.uk/arthroscopic-femoroacetabular-surgery-for-hip-impingement-syndrome-ipg408


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BACK TO INDEX

Policy statement: Hysterectomy for heavy menstrual bleeding

Status: Threshold

Hysterectomy for heavy menstrual bleeding is considered low priority and will be funded only under the following circumstances: There has been a prior unsuccessful trial with a levonorgestrel intrauterine system

MirenaR) and it has failed to relieve symptoms unless it is medically inappropriate, contraindicated or declined by the patient AND At least two of the following treatments have failed to relieve symptoms, are not appropriate, are contraindicated or declined by the patient:

AND

Non-steroidal anti-inflammatory agents OR

Tranexamic acid OR

Other hormone methods (e.g. combined oral contraceptives, injected progesterons, Gn-RH analogue)

Surgical treatment such as endometrial ablation, thermal balloon ablation, microwave endometrial ablation, endometrial resection, uterine-artery embolisation (in selected cases) or myomectomy have failed to relieve symptoms, are not appropriate, are contraindicated or declined by the patient. NOTE: Removal of healthy ovaries at the time of hysterectomy should not be undertaken as per the NICE guidelines.

Requirements for approval Evidence from GP notes that the treatment pathway above has been followed including information on when and why a patient declines treatment.

Smoking Status of all patients undergoing procedures in secondary care: Patients should be aware their smoking status will be determined, where relevant in all those being referred to secondary care for treatment. All patients who are smokers should be referred to smoking cessation services at the initial assessment appointment. If funding is approved, patients should be aware that the CCG has a


Page 85 of 152

policy of ‘Stop before the Op’ which means patients must be non-smoking for a minimum period of 8 weeks prior to any operation taking place.








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BACK TO INDEX

Policy statement: Knee Arthroscopy

Status: Threshold

Arthroscopy of the knee can be undertaken where a competent clinical examination

(or MRI scan if there is diagnostic uncertainty or red flag* symptoms/signs/conditions) has demonstrated clear evidence of an internal joint derangement (meniscal tear, ligament rupture or loose body) and where conservative treatment has failed or where it is clear that conservative treatment will not be effective. Knee arthroscopy can be carried out for:

Removal of loose body where there is a clear history of locking and other

treatment has failed

Meniscal surgery

Repair of cruciate ligament

Synovectomy / symptomatic plica

Treatment of osteoarthritis with arthroscopic lavage (washout) and debridement only if the person has knee osteoarthritis with a clear history of mechanical locking (not gelling, ‘giving way’ or X-ray evidence of loose bodies)

Continuing diagnostic uncertainty following MRI, but only in the following circumstances:

o When the MRI is of low quality and cannot be interpreted o The report shows a significant degree of movement artefact o Where the patient has had an Anterior Cruciate Ligament

reconstruction and the metal screws are affecting the image quality o Patient has a pacemaker

Knee arthroscopy should NOT be carried out (and will not be funded) for any of the following indications:

Diagnostic purposes only (noting the above exception)

Treatment of osteoarthritis with arthroscopic lavage (washout) and debridement. In line with NICE guidance CG59; this should not be offered as part of treatment for osteoarthritis unless the person has knee osteoarthritis with a clear history of mechanical locking (not gelling, ‘giving way’ or X-ray evidence of loose bodies)

*Red flag symptoms or signs include recent trauma, constant progressive non-

mechanical pain (particularly at night), previous history of cancer, long term oral

steroid use, history of drug abuse or HIV, fever, being systematically unwell, recent


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unexplained weight loss, persistent severe restriction of joint movement, widespread

neurological changes, and structural deformity. Red flag conditions include infection,

carcinoma, nerve root impingement, bony fracture and avascular necrosis

Rationale: In relation to treatment of osteoarthritis with arthroscopic lavage and debridement NICE1 looked at studies to investigate the efficacy and safety of arthroscopic lavage (with or without debridement) compared with tidal irrigation and placebo with respect to symptoms, function and quality of life. Eight RCTs were compared. NICE highlighted that there is uncertainty regarding the efficacy of arthroscopic knee washout where the key outcomes are relief from pain and reduction of mechanical symptoms.

Diagnostic Arthroscopy - In the past it has been used as an effective diagnostic tool for knee disorders/pain as it offers the advantage of being accurate and enabling treatment at the same time as diagnosis. However studies have promoted the use of MRI as a primary diagnostic tool as it is non-invasive, safer and less expensive than arthroscopy. Adding to this evidence are two prospective cohort studies, one of which demonstrated MRI to be a sensitive and specific diagnostic tool for knee disorders2 and the other showed MRI to be no better at predicting the final diagnosis than a competent clinical examination3. However, MRI scan of the knee is useful for situations where there is diagnostic uncertainty.

Note: Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed as per the CCG policy.

References:

1) Osteoarthritis – National Clinical Guideline for Care and Management in

Adults, (2008) NICE http://guidance.nice.org.uk/CG59

2) Vincken PW et al: Effectiveness of MR imaging in selection of patients with arthroscopy of the knee. Radiology.2002 Jun: 223(3(:739-46)

3) Brooks, S, Morgan, M: Accuracy of clinical diagnosis in knee arthroscopy. Annals of the Royal College of Surgeons of England 2002, 84:265-268







http://guidance.nice.org.uk/CG59


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Policy statement: Primary Total Knee Replacement Surgery – Non-

Acute

Status: Threshold

Policy:

Primary elective total knee replacement (TKR) is most commonly performed for

knee joint failure caused by osteoarthritis (OA); other indications include

rheumatoid arthritis (RA), juvenile rheumatoid arthritis, osteonecrosis and other

types of inflammatory arthritis1. This threshold relates to adults.

The aims of TKR are relief of pain and improvement in function. TKR can be very

successful for the appropriate patients with over 90% of TKR still in place and

functioning well 10 to 15 years after surgery1.

The CCG will agree to fund referrals and surgery, under prior approval, where the

patient meets the following criteria. Criteria for immediate / urgent referral are given

for information.

Criteria for immediate/urgent referral to orthopaedic services* (see below for referral criteria definitions): *Based on RAND appropriateness methodology developed by Antonio Escobar and Colleagues12.

Symptoms indicating a rapid deterioration in the joint. Persistent symptoms that are causing severe disability.

Criteria for routine referral to orthopaedic services:

Moderate to severe persistent pain not adequately relieved by an extended course of non-surgical management. AND clinically significant functional limitation resulting in a diminished quality

of life. AND radiographic evidence of joint damage.

Thresholds for knee replacement surgery The following groups of patients would benefit from TKR:

Where the patient complains of:

a. Intense or severe symptomatology. b. AND has radiological features of severe disease.

c. AND has demonstrated disease within all three compartments of the knee


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(tri-compartmental) or localised to one compartment plus patello-femoral

disease (bi-compartmental).

OR

Where the patient complains of:

a. Intense or severe symptomatology.

b. AND has radiological features of moderate disease.

c. AND is troubled by limited mobility or stability of the knee joint.

OR

Where the patient complains of: a. Severe symptomatology.

b. AND has radiological features of slight disease.

c. AND is troubled by limited mobility or stability of the knee joint

Referral criteria definitions1:

Variable Definition

Mobility and stability

Preserved mobility

and stable joint

Preserved mobility is equivalent to minimum range of

movement from 0 to 90 . Stable or not lax is equivalent to an absence of slackness of

more than 5mm in the extended joint.

Limited mobility

and / or stable joint

Limited mobility is equivalent to a range of movement less

than 0 to 90 . Unstable or lax is equivalent to the presence of slackness of

more than 5mm in the extended joint.

Symptomatology

Slight Sporadic pain Pain when climbing / descending stairs

Allows daily activities to be carried out (those requiring great

physical activity may be limited)

Medication: aspirin, paracetamol or non-steroidal anti-


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inflammatory drug (NSAID) analgesia to control pain, with no

side effects.

Moderate Occasional pain. Pain when walking on level surfaces (half an hour, or

standing).

Some limitation of daily activities. Medication: aspirin, paracetamol or NSAID to control pain,

with no / few side effects.

Intense Pain of almost continuous nature. Pain when walking short distances on level surfaces or

standing for less than half an hour.

Daily activities significantly limited.

Continuous use of NSAIDs for treatment to take effect.

Requires the sporadic use of support systems (walking stick,

crutches).

Severe Continuous pain. Pain when resting.

Daily activities significantly limited constantly.

Continuous use of analgesics / NSAIDs with adverse effects

or no response.

Requires more constant use of support systems (walking

stick, crutches).

Radiology

Slight Ahlback grade I

Moderate Ahlback grade II and III

Severe Ahlback grade IV and V

Localisation

Unicompartmental Excluded patello-femoral isolated.

Bicompartmental Unicompartmental plus patello-femoral.


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Tricompartmental Disease affecting all three compartments of the knee.

Definition: Relevant OPCS(s):

W40 – Total prosthetic replacement of knee joint using cement

W41 – Total replacement of knee joint not using cement

W42 – Other total replacement of knee joint

Rationale:A small number of patients experience complications following elective

total knee replacement that can be devastating and for this reason, patients should

not be considered for joint replacement until their condition has become chronic

and conservative methods have failed.1,6,12

Guidance to Primary Care on the treatment of knee pain due to osteoarthritis The Musculoskeletal Services Framework from the Department of Health (DH) and

guidance from NICE, the GP Training Network and the National Institute of Health

(NIH) Consensus Panel suggests that2-5:

Management of common musculoskeletal problems, including knee pain, in primary care is ideal.

Primary care practitioners need direct access to therapy, walking aids, dietetic and health promotion services.

Primary care management should seek to maximise the benefits of surgery and minimise complications when surgery is necessary.

The initial non-surgical management of knee pain due to OA should provide a

package of care that may include weight reduction, activity modification, patient

specific exercise programme, adequate doses of NSAIDs and analgesics, joint

injection, walking aids and other forms of physical therapies.2-6 Referral should be

considered when relevant pre-existing medical conditions have been optimised.6

Contraindications for TKR include: Local or systemic infection. Medical conditions that substantially increase the risk of serious peri-operative

complications or death. Advanced age and obesity (BMI 30 to 39) are NOT contraindications to TKR.

Obesity There is evidence that patients who are morbidly obese (BMI>40) have increased

complications following knee surgery.8 If morbidly obese patients are to have their

knee surgery delayed because of their weight, they should be referred into a weight

loss programme that meets their specific needs.9-12 There will be a community

weight reduction programme available in west Essex from 1st April 2011.


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Evidence indicates that knee disability in overweight or obese patients can be

effectively improved following weight reduction at a rate of 0.24% reduction per

week or a total weight reduction in excess of 5%.13 Evidence also suggests that

patients who are overweight (BMI 25-29.9) or obese (BMI >30) benefit from support

through a community weight reduction programme to achieve clinical weight loss of

at least 5% over 20 weeks before referral for knee replacement surgery.11-13

Smoking status of all patients undergoing procedures in secondary care:

Patients should be aware that their smoking status may need to be determined if


that patients are non-smoking for a minimum period of 8 weeks prior to any surgical

operation taking place, especially if under general anaesthetic. Patients should be

made aware that there is strong evidence that smokers are more likely to have

lung, heart and infectious complications and remain in hospital longer after their

operation. Support is available through the Health Promotion Team to help patients

who wish to stop smoking.

GLOSSARY

BMI Body Mass Index provides an objective assessment of

whether a person is at a healthy weight in relation to

height, to enable an estimation to be made of an

individual’s risk of mortality or morbidity. The BMI is

calculated by dividing the person’s weight in kilograms

by their height in metres squared

References:

1. Bedfordshire and Hertfordshire Priorities Forum Statement Number 33: Referral criteria for patients from primary care presenting with knee pain due to osteoarthritis and clinical threshold for elective primary knee replacement surgery, February 2007.

2. National Institute of Clinical Excellence. Primary Care Referral Guidelines for Common Conditions. NICE 2003; London.

3. National Institute of Health. Consensus development program. Dec 2003. See also the National Guideline Clearing House (www.guideline.gov).

4. British Orthopaedic Association. Total Knee Replacement; A Guide to Best Practice. 2001

5. The Musculoskeletal Services Framework – A joint responsibility: doing it differently. Department of Health, 2006.

6. Quintana JM, Escobar A, Arostegui I, Bilbao A, Azkarate J, Goenaga I and Arenaza J. Health related quality of life and appropriateness of knee or hip joint replacement. Archives of Internal Medicine, 2006; 166: 220-226.

7. Furlong C. Preoperative Smoking Cessation: A model to Estimate Potential


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Short Term Health Gain and Reductions in Length of Stay. A Report by the London Health Observatory, 2005.

8. Amin AK, Clayton RAE, Patton JT, Gaston M, Cook, RE and Brenkel IJ. Total knee replacement in morbidly obese patients results of a prospective, matched study. Journal of Bone and Joint Surgery British, 2006; 88: 1321-1326.

9. Gillespie GN and Porteous AJ. Obesity and knee arthroplasty. The Knee, 2007; 14: 81-86.

10. Martin K, Fontain KR, Nicklas BJ, Dennis KE, Goldberg AP and Hochberg MC. Weight loss and exercise walking reduce pain and improve physical functioning in overweight postmenopausal women with knee osteoarthritis. Journal of Clinical Rheumatology, 2001; 7: 219-223.

11. National Institute of Clinical Excellence and National Collaborating Centre for Primary Care. Obesity: the prevention, identification, assessment and management of overweight and obesity in adults and children. NICE December 2006; London.

12. Escobar A, Quintana JM, Arostehui I, Azkarate J, Güenaga, Arenaza JC, Garai I. Development of explicit criteria for total knee replacement. International Journal of Technology Assessment in Healthcare, 2003; 19: 57-70.

13. Christensen R, Bartels EM, Astrup A and Bliddal H. Effect of weight reduction in obese patients diagnosed with knee osteoarthritis: a systematic review and meta analyses. Annals of the Rheumatic Diseases, 2007; 66: 433-439.

14. Dawson J, Fitzpatrick R, Fletcher J and Wilson R. Osteoarthritis Affecting the Hip and Knee. In Health Care Needs Assessment: The epidemiologically based needs assessment reviews, Second Edition, Volume 1. Editors; Stevens A, Raftery J, Mant J and Simpson S. Radcliff, 2004; Radcliffe Publishing Oxford and San Francisco.

15. Black’s Medical Dictionary. 40th Edition. A & C Black. London 2002.








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Policy statement: Vaginal Labia Reduction/Refashioning


If a clinician wishes to refer the patient to secondary care then funding must be approved by the CCG and will only be considered in the following circumstances. In all cases, medical photography will be required for the individual prior approval Labiaplasty Labiaplasty is generally a cosmetic procedure to improve appearance alone and is not routinely funded. Requests for labiaplasty will be considered for the following indication:

Where repair of the labia is required after severe trauma; common consequence of childbirth will not be sufficient reason.

Vaginoplasty Non-reconstructive vaginoplasty or "vaginal rejuvenation" is used to restore vaginal tone and appearance and is not routinely funded. Requests for vaginoplasty will be considered for the following indications:

Congenital absence or significant developmental/endocrine abnormalities of the vaginal canal,

Where repair of the vaginal canal is required after severe trauma; common consequence of childbirth will not be sufficient reason.

Hymenorrhaphy Hymenorrhaphy, or hymen reconstruction surgery, is a cosmetic procedure and is not routinely funded. Please refer also to the cosmetic surgery general principles prior to submitting an exceptional funding request.




Date approved: 20th December 2013




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Policy statement: Laser treatment for severe Facial Hirsutism


Policy:

Laser treatment for facial hirsutism is considered a low priority treatment and will only be provided in exceptional circumstances.

Definition: Laser treatment is recognised as being the most effective treatment for the removal of excessive unwanted hair. Only hairs actively growing in anagen are susceptible to permanent laser hair removal. A typical growth cycle of facial hair is approximately six months. Local treatments available for the removal of unwanted hair include bleaching, shaving, plucking, depilatory creams, waxing, electrolysis and laser treatment.

Rationale: Laser treatment is not always a cure and can lead to ongoing treatment.

Criteria: Patients will only be considered for laser treatment if they have confirmed severe hirsutism of face (assessed by local Consultant Endocrinologist) that requires daily shaving which has resulted in a significant withdrawal from social, educational and/or work environments. A patient meeting these criteria will be eligible for up to six laser treatments to the face and neck areas. This treatment will be provided over a six month period. If after 6 months the local Consultant believes more treatments are required then an application for these should be made to the Special Cases Co-ordinator.

Risks: Laser treatment will not be effective and is not as effective in dark skinned women.

GLOSSARY:

Hirsutism Hirsutism is the name given for the excessive growth of hair on areas of the body where such growth is not expected

Anagen The growth cycle








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Policy statement: Laser treatment for Soft Palate (snoring)


Surgical treatment for simple snoring is considered a low priority and will not

normally be funded. Surgical interventions for simple snoring include the following

and are not normally funded:

Uvulopalatopharyngoplasty (UP3 or UPPP)

Laser assisted uvulopalatoplasty (LAUP)

Radiofrequency ablation (RFA)

Soft palate implants In circumstances where a cancer is suspected, the 2 week wait referral process

should be used.

Please also refer to policy on Septoplasty and rhinoplasty.

Rationale: There is limited evidence on the efficacy of the surgical interventions

listed. A systematic review in 20091 concluded that both UP3 and LAUP reduced the

number of snores per hour and produced a modest reduction in snoring loudness,

but there appeared to be no consistent and significant differences in terms of the

effectiveness of the two procedures. RFA was associated with a reduction in partner

assessed snoring intensity although evidence for an objective reduction in snoring

sound levels was mixed. Soft palate implants were moderately effective at reducing

partner-rated snoring intensity, but had no effect on objective snoring indices.

NICE guidelines on RFA2 concluded that evidence on the short term efficacy is

limited and long term outcomes uncertain. NICE guidelines on soft palate implants

for snoring3 states that current evidence raises no major safety concerns, however

the evidence on efficacy is based on small case series only and there is a lack of

well-controlled and comparative data.

Please refer also to the cosmetic surgery general principles prior to submitting an exceptional funding request


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References:

1) Main C, Liu Z, Welch K, Weiner G, Jones SQ, Stein K. Surgical procedures and non-surgical devices for the management of non-apnoeic snoring: a systematic review of clinical effects and associated treatment costs. Health Technol Assess 2009;13(3). http://www.hta.ac.uk/fullmono/mon1303.pdf

2) Radiofrequency ablation of the soft palate for snoring May 2005 NICE http://www.nice.org.uk/nicemedia/pdf/ip/IPG124guidance.pdf

3) Soft-palate implants for simple snoring. November 2007 NICE http://www.nice.org.uk/nicemedia/pdf/IPG240QRG.pdf







http://www.hta.ac.uk/fullmono/mon1303.pdf

http://www.nice.org.uk/nicemedia/pdf/ip/IPG124guidance.pdf

http://www.nice.org.uk/nicemedia/pdf/ip/IPG124guidance.pdf

http://www.nice.org.uk/nicemedia/pdf/IPG240QRG.pdf


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Policy statement: Liposuction


Liposuction may be useful for contouring areas of localised fat atrophy or

pathological hypertrophy e.g. multiple lipomatosis, lipodystropies. Liposuction is

sometimes an adjunct to other surgical procedures. It will not be funded simply to

correct the distribution of fat.










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Policy statement: Lycra Dynamic Splinting for Children with

Neurological Impairment

Status: Not Normally funded

Requests for funding will only be considered on an individual patient basis by

exceptional treatment panels. The referral needs to come from a local lead specialist

physiotherapist or occupational therapist. The expected benefits for that patient over

other treatments must be clearly quantified.

Expert opinion suggests that younger children with athetoid disorders (involuntary

movements), those with quadriplegic palsy and those with neuromuscular disorders

benefit the most. Lycra dynamic splinting splinting is not suitable for clients who have

fixed deformities of a bony nature which are not amenable to change. Compliance

has a significant role to play in determining outcome, as it does for all therapy and

medical interventions. The client and family or carers, who may be assisting them to

apply the splints, are made fully aware of the commitment required to ensure

success.

Provision of subsequent garments will depend on clear, quantifiable demonstration

of benefit for the individual patient which has been set upfront.








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Policy statement: Lymphoedema Services (Specialist treatment in

Private Sector)


Policy:

Treatment of patients with Lymphoedema should be carried out through local

Lymphoedema services. Treatment of Lymphoedema by specialist units in the

private sector will only be funded in exceptional circumstances following involvement

of appropriate local services.

Definition:

Lymphoedema is swelling due to excess accumulation of fluid in the tissues caused by

inadequate lymphatic drainage. It can affect any part of the body, but most commonly

affects the arms and legs. There is no agreement on the quantitative definition of

Lymphoedema.

Lymphoedema can be classified as primary or secondary. Primary lymphoedema is due to

abnormality intrinsic to the lymphatic system. Secondary Lymphoedema is due to

damage/obstruction of the lymphatic system. This can be caused by cancer or cancer

treatment, but there are a variety of other, non-cancer causes. Historically, Lymphoedema

services have often developed in relation to cancer services and have extended their

scope to treat other types of Lymphoedema.

Lymphoedema is essentially incurable as it represents end-stage failure of lymph drainage

and will invariably progress unless controlled. Skin infections occur which can necessitate

hospital admissions and there is increasing lack of mobility if patients are untreated.

Symptoms include the weight and discomfort of the affected limb, recurrent inflammation

and infection, and the psychological distress caused by the appearance on the limb.

Criteria:

As Lymphoedema is only one cause of oedema the GP should ensure:

1. the correct diagnosis has been made (remembering that most causes of peripheral oedema are cardiac, renal, hepatic or venous in origin, rather than Lymphoedema);

2. the oedema is persistent or greater than 3 months duration; or


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3. the patient is at known risk of Lymphoedema. Once correct diagnosis has been established, the patient should be referred on to a local

Lymphoedema service.

Where children or younger adults present with limb swelling, the GP may wish to refer to

the appropriate specialist to exclude diagnosis such as malignant or vascular causes,

dependant on the exact clinical picture. If Lymphoedema is diagnosed following

investigation, these patients should be regarded as high priority by local Lymphoedema

services, to prevent avoidable deterioration.

Intensive inpatient therapy will not be provided.

Estimated number of people affected: Because of the lack of agreement on the quantitative definition of Lymphoedema, there is a

lack of good quality epidemiological date on its incidence and prevalence.

Resource implications: In the short term, this policy emphasises appropriate referral into current local

Lymphoedema services. In the future, there may be resource implications for further

development of local services, in line with the emerging National Framework for

Lymphoedema.

Health benefits: Treatment of Lymphoedema usually consists of a programme of physical treatment divided

into two phases – reduction and maintenance.

Reduction is necessary for more severe oedema and is performed in two ways:

Multi-layer Lymphoedema bandaging

Manual lymphatic drainage (MLD) – a type of skin massage performed by trained therapists which stimulates lymph flow proximally

Maintenance therapy has four components:

Skin care – to maintain good tissue condition and reduce risk of infection

External compression – elastic compression garments to reduce new lymph

formation and enhance lymph drainage by improving muscle pump efficiency

Exercise – dynamic muscle contractions encourage lymph drainage

Simple lymphatic drainage (SLD) – a modified form of MLD undertaken by the patient or carer.

A Cochrane Review of physical therapies for Lymphoedema was carried out in 2004. The

review included studies that looked at the effects over a period longer than six months.

Only three studies involving 150 randomised patients were found that satisfied the criteria.

One concluded that wearing a compression sleeve is beneficial; another that MLD provided

no extra benefit above use of a compression sleeve; a third that bandage plus hosiery

resulted in a greater reduction of excess limb volume than hosiery alone. The reviewers


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conclude that there is not currently enough good quality evidence to draw conclusions

about which treatment is most useful. A review of physical therapies for Lymphoedema was also carried out by North and East

Hertfordshire PCTs, using the Critical Appraisals Skills Programme (CASP) for randomised

controlled trials (RCT’s). This review identified eleven relevant RCTs and concluded that

there is evidence that elastic compression sleeves, multi-layer compression badges and

manual lymph drainage (MLD) are effective in the treatment of Lymphoedema. The

relative efficacy of MLD to other interventions needs to be clarified.

Risks: There is a risk that local Lymphoedema services may have difficulty prioritising demand

and may not be rapidly accessible for patients with deteriorating Lymphoedema.

Referral process: Referrals will not be accepted directly from General Practitioners. All referrals/requests should be on the West Essex CCG

GLOSSARY

Lymph

System:

Is a network of organs, lymph nodes, lymph ducts and lymph vessels that

produce and transport lymph from tissues to the bloodstream. The lymph

system is a major component of the body’s immune system.

References:

12. Badger et al. Physical Therapies for reducing and controlling lymphoedema of the limbs. Cochrane Database of Systematic Reviews 2004, Issue 4.

13. Report on provision of lymphoedema services for East and North Hertfordshire PCT’s. Dr Hilary Angwin.

14. Lymphoedema Framework Journal. 1 Edition. Autumn 2003. 15. Moffat et al. Lymphoedema: an underestimated health problem. OJM Vol 96 no 10.

2003 16. British Lymphology Society, www.lymphoedema.org/bls

17. Black’s Medical Dictionary. 40th Edition. A & C Black, London 2002







http://www.lymphoedema.org/bls


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Policy statement: Mastopexy (Breast Lift)


This is included as part of the treatment of breast asymmetry and reduction but not

for purely cosmetic/aesthetic purposes such as post-lactational ptosis.










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Policy statement: Minor Hand Conditions

Status: Threshold

Policy:

Referral to a hospital consultant for Minor Hand conditions such as those mentioned

below are considered low priority, and will only be provided under the NHS in line

with the guidance below.

Definition:

The Minor Hand conditions covered in this policy are stated below:

Wrist Ganglia

Ganglia are caused by cystic degeneration of a joint capsule or tendon sheath. Lesions at the base of the digits are often small but very tender (seed ganglion). Mucoid cysts arise at the distal interphalangeal joint and may disturb nail growth. Ganglia arising at the level of the wrist are rarely painful and most will resolve spontaneously within 5 years. The recurrence rate after excision of wrist ganglia is between 10-45 %.

Trigger Finger

A tender nodule in the flexor tendon at base of a finger or thumb causing a snapping of the finger/thumb as it is extended from a flexed position.

Dupu ytren’ s Contra c ture

Nodular or cord-like thickening of the palmar fascia causing a tethering of the digits and a loss of range of extension.

Rationale:

Many hand conditions occur commonly, cause few serious symptoms and will

generally resolve spontaneously. Given the potential complications of surgical

procedures and the duty of the CCG to use its limited resources to provide the

greatest benefit to the population of West Essex, the below criteria for referral have

been developed. These criteria are aimed at offering treatment to those who need

it most and who are most likely to benefit from surgical treatment.

Wrist Ganglia:

Ganglia arising at the level of the wrist are rarely functionally impairing and


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about 50% will resolve spontaneously within 5 years. In the longer term approximately 60% of ganglia remain resolved following aspiration and about 70% following surgery. When other complications of surgery such as scar sensitivity, joint stiffness or distal numbness are taken into account operating is usually an unattractive option. Appropriately counselled patients will often not request surgical referral. Patients with asymptomatic ganglia should not be referred to secondary care. They can be reassured in primary care and asked to seek assistance if the ganglion becomes symptomatic.

Trigger Finger:

Trigger finger and thumb in adults is caused by thickening of the A1 pulley. It is most common in middle aged women, is more frequent in diabetics but is usually idiopathic. Patients complain of the finger becoming stuck bent. When the digit is straightened there is a palpable clunk which is painful. Examination reveals a tender thickening over the A1 pulley which is at the level of the distal palmar crease in the fingers and at the base of the thumb.

Conservative treatment includes rest and avoiding precipitating activities.

Non-steroidal anti-inflammatory drugs will often settle early cases. Injection

of hydrocortisone is safe and can provide lasting relief in up to 70% of

cases.

Trigger thumb is also very common and often more painful. It also occurs in

infants due to a lump in the tendon rather than pulley thickening. In adults

trigger thumb seems to respond less well to injections than fingers but it is

still worthwhile. In infants surgery is often required if the deformity persists

after 1 year.

Dupuytrens Contracture:

Most patients with Dupuytren's disease do not need treatment, but regular follow-up is needed to detect early joint contracture. Intervention is almost exclusively surgical and should be considered when the patient is having functional difficulties. Recurrence is very common after surgery (up to 50%) but some patients with a ‘Dupuytren’s diathesis’ are particularly at risk. A recent review regarding this found that with a family history, bilateral disease, Garrod’s pads, male sex and onset less than 50 years the risk of recurrent disease was 71%. With none of these risk factors the rate was 23%.

Referral Criteria:

Wrist Ganglia:

Surgery for ganglion of the wrist will only be funded for patients who have fulfilled

the criteria as follows:-

there are symptoms associated with the ganglia such as pain, loss of sensation in certain parts of the hand, neurological loss or weakness of the wrist with the ganglion, and restriction of work or hobbies because of the


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ganglia

patients are aware that most ganglia resolve spontaneously over time

Patients are aware of the complications of excision such as scar

tenderness, stiffness or numbness, and likelihood of recurrence. Trigger Finger:

Referrals for surgery for trigger finger will only be funded for patients who have

fulfilled the criteria as follows:-

failure to respond to conservative measures [e.g. up to 2 hydrocortisone injections]

where the patient has a fixed deformity that cannot be corrected. Dupuytrens Contracture:

Simple nodules in the palm are not an indication for referral.

Surgery for Dupytren’s contracture will only be funded for patients who have a

flexion contracture exceeding 30 degrees at the metacarpophalanageal joint and/or

a contracture exceeding 10 degrees at the proximal interphalangeal joint. Needle

apronectomy will not be funded (this may be reviewed in light of any published

NICE guidance for the treatment)









GLOSSARY:

Interphalangeal

joint:

A joint between the bones of a finger

Excision: Surgical removal

Aspiration: The removal of fluid and/or material with a syringe

Dysaesthesia: A loss of sensation

Thenar

abduction:

Abduction of the thumb, when it is moved away from the palm


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REFERENCES: Wrist Ganglia: 1. Wildin C, Dias J, Heras-Palou C, Bradley M, Burke FD. Trends in elective hand surgery referrals from primary care. Annals of The Royal College of Surgeons of England 2006; 88 [6]: 543-546 2. Dias J, Buch K. Palmar wrist ganglion: does intervention improve outcome? A prospective study of the natural history and patient-reported treatment outcomes. J Hand Surg (Br) 2003;2: 172-6. 3. Bandolier. www.jr2.ox.ac.uk/bandolier/booth/miscellaneous/wristgang.html 4. FD Burke et al. Primary care referral protocol for wrist ganglia. Postgrad Med J 2003 79: 329-331. Trigger Finger: 1. Marks MR, Gunther SF: Efficacy of cortisone injection in treatment of trigger fingers and thumbs. J Hand Surg [Am] 1989; 14:722–727. 2. Peters-Veluthamaningal C, Winters JC, Groenier KH, Meyboom-de Jong B. Corticosteroid injections effective for trigger finger in adults in general practice: a double-blinded randomized placebo controlled trial. Ann Rheum Dis. 2008 Jan 7; [Epub ahead of print] 3. Fleisch SB, Spindler KP, Lee DH.Corticosteroid injections in the treatment of trigger finger: a level I and II systematic review. J Am Acad Orthop Surg. 2007 Mar;15(3):166-71

Dupuytrens Contracture: 1. Bird B, Ball C, Balasuntharam P. Rehabilitation after surgery for Dupuytren’s Contracture. (Protocol) Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD006508. DOI: 10.1002/14651858.CD006508. 2. Townley W A, Baker R, Sheppard N, Grobbelaar A O. Clinical review: Dupuytren's contracture unfolded BMJ 2006;332:397-400 (18 February), doi:10.1136/bmj.332.7538.397 3. Hindocha S, Stanley JK, Watson S, Bayat A. Dupuytrens’s diathesis revisited: Evaluation of prognostic indicators for risk of disease recurrence. J Hand Surg (Am) 2006 Dec;31(10):1626-34.







http://www.ingentaconnect.com/content/rcse/arcs%3Bjsessionid%3D1i287wbevl9f0.henrietta

http://www.ingentaconnect.com/content/rcse/arcs%3Bjsessionid%3D1i287wbevl9f0.henrietta

http://www.jr2.ox.ac.uk/bandolier/booth/miscellaneous/wristgang.html

http://www.ncbi.nlm.nih.gov/pubmed/18180279?ordinalpos=4&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Fleisch%20SB%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Spindler%20KP%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Lee%20DH%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus


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Policy statement: Nipple Inversion

Status: Threshold

Nipple inversion may occur as a result of underlying breast malignancy. If the

inversion is newly developed, it requires urgent referral and assessment.

Surgical correction of nipple inversion should only be available for functional reasons

in a post-pubertal woman and if the inversion has not been corrected by correct use

of a non-invasive suction device.










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Policy statement: Penile Implants


This will not be funded other than post cancer reconstruction.










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Policy statement: Photodynamic Therapy for Age-related Macular

Degeneration

Status:

Threshold

Summary:

NICE (National Institute for Clinical Excellence) has made the following recommendations about the use of photodynamic therapy (PDT) to treat age-related macular degeneration (ARMD)

NICE recommends PDT for people with wet ARMD who have a confirmed diagnosis of classic subfoveal choroidal neovascularisation (CNV) with no sign of occult CNV. People should also have at least 6/60 vision – this means that they can see (with glasses if they usually wear them) the same line of test letters 6 meters away that a person with normal vision can see when 60 meters away. PDT treatment should be carried out by doctors who specialist in treating disorders of the retina and who have experience in using PDT.

PDT is not recommended for people who have wet ARMD with mostly classic subfoveal CNV (that is, at least half is classic but there is also some occult CNV). The exception is where the person is treated as part of a clinical study designed to provide useful information on the effectiveness of the treatment.

NICE has not made any recommendation about PDT for people who have ARMD with occult CNV. This is because, when the appraisal process started, the light- sensitive substance was not licensed to be marketed or prescribed for occult CNV in the UK. (This is because its ‘marketing authorisation’, which is normally needed before a medicine can be marketed or prescribed, did not cover patients with occult CNV. The process of giving medicine its marketing authorisation is not related to the NICE appraisal process and it is not carried out by NICE. Further information on this is available from the Medicines and Healthcare Products Regulatory Agency (MHRA).

Everyone with ARMD who started a course of PDT on the NHS before the NICE guidance was issues should have the option of continuing the course until their clinical condition indicates that it is appropriate to stop. This may be judged by the effects of PDT on the results of fluorescein angiography and the rate of loss of vision. Individual patients will need to be assessed by a referring consultant against the following criteria.


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Criteria for patients:

People with wet ARMD who have a confirmed diagnosis of classic subfoveal choroidial neovascularisation (CNV) with no sign of occult CNV

Predominantly “classical” features

Visual acuity 6/60 or better

Lesions smaller than or equal to 5400um

Commissioners will need to ensure criteria for provider units are met, and approve each referral on an individual basis.

Criteria for provider units:

A sub regional centre with retinal expertise and access to stereoscopic fluorescein angiography

Participating in a systematic and ongoing evaluation supported by an appropriate clinical study protocol

Participants in the SERNIP reporting system (for adverse events)

Definition: Macular degeneration is relatively common disorder of the eye among the older population. It causes significant morbidity due to loss of central vision, for which there is currently no safe and effective treatment. Photoreative therapy is a treatment which uses a combination of a photoreative chemical and illumination from a laser source, to treat the new vessel formation in the retina associated with this disease. This treatment appears to reduce visual loss in a specific group of patients, but will not improve vision.

Health benefits: From one large multi-centre randomised trial, results suggest that if a subgroup of patients, with >50% neovascular macular degeneration, are treated according to trial protocols, only two people need to be treated to prevent on person losing 3 or more lines of vision over one year. This may allow maintenance of independence in an elderly person. However, results are not yet available for more than two years of follow up. NICE has included this therapy on its formal work programme and is due to report in July 2002, but a policy is needed for the interim period.

Risks: Due to the short follow up time of the only existing trial, it is not possible to confidently predict the risks. There have been some instances of early visual loss after treatment, although this does not appear to be significant and, in general, the rate of adverse events in trial was low. The main risk is the assumption of efficacy over time when this has not yet been fully demonstrated.

Priority: Low priority treatment, except for those people fulfilling the outlined criteria for whom benefit has been shown.

Resource Implications: This policy does not change current practice, therefore, the resource implications remain unchanged.


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GLOSSARY

Choroid: Vascular layer of tissue underlying the retina

Macular: Pertaining to the macular, an area of the retina of the eye with the ability to produce a high level of visual acuity (i.e. distinguish objects clearly)

Neo-vascularisation: The formation of new blood vessels

Photodynamic: Altered by light

Retina: Tissue lining the inside of the eye, containing cells which are sensitive to light. Information is passed from the retina to the optic nerve, where images are transmitted to the brain.

SERNIP: Safety and Efficacy Register of New Interventional Procedures, set up under the auspices of the Academy of Royal Medical Colleges in 1996.

Subfoveal/juxtafoveal: Under or near to the fovea, the central area of the macula.








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Policy statement: Pinnaplasty/Otoplasty


Funding may be available if one of the following sets of criteria are met: SET A

Age between 5 years old and 18 years old at the time of referral and procedure

The child has prominent ears

The child is suffering from distress, e.g. from bullying, the impact of this distress

should be recorded within the application.

Surgical correction must be desired by the child; referral should not be made for

children who appear indifferent or opposed to the idea of surgery. Parents

requesting surgery for their child in order to prevent distress when their child

starts school or at some time in the future should be advised that referral should

wait until their child specifically requests treatment.

SET B

In children under the age of 5 years old when correction of ear prominence is

required to better support a hearing aid

Funding is not available for pinnaplasty/otoplasty in adults over the age of 18 years.

Rationale Pinnaplasty and otoplasty surgery are surgical methods of correcting prominent ears. Ear prominence is very common and can lead to low self-esteem, bullying and significant psychological morbidity in childhood and adolescence. A Commissioning Guide produced by the Royal College of Surgeons advises that surgical correction should only be offered to children between the ages of 5 years and 18 years and only in cases when the child desires the correction. Referral to a specialist should not be made for children who appear indifferent or opposed to the idea of surgery, any parent requesting surgery for their child in order to prevent psychological distress should be advised that referral should wait until their child specifically requests treatment.


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In infants up to the age of 6 months cartilage moulding devices should be used, when correctly applied and well tolerated they can reduce ear prominence, however they are most effective in the neonatal period when the cartilage is malleable and therefore they should be applied as soon as possible. Surgery should not be offered to children under the age of 5 years, they are less likely to tolerate the procedure or comply with dressings care. Psychological distress is unlikely to have developed prior to the age of 5 years and therefore surgery should be delayed until later. However the Royal College of Surgeons advises that surgical correction may be considered appropriate in children under the age of 5 years when a hearing aid is required which will be better supported following the correction of ear prominence. References Royal College of Surgeons. Pinnaplasty Commissioning Guide. 2012. Available at [http://www.rcseng.ac.uk/healthcare-bodies/docs/published-guides/pinnaplasty] Note: Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed as per the CCG policy.

Approved by (committee) Health and Care Commissioning Committee


Produced by (Title); Clinical Commissioner

Review date: May 2017

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Policy statement: Plagiocephaly


Helmets (cranial moulding devices) will not be eligible for NHS funding.

Plagiocephaly may be divided into craniosynostosis, which results from premature

closure of one or more of the cranial sutures, and nonsynostotic or positional

plagiocephaly (also referred to as deformational plagiocephaly, non-synostotic

plagiocephaly, positional plagiocephaly, flat-head syndrome and occipital

plagiocephaly).

This distinction is highly important as craniosynostosis carries a significant risk of

raised intracranial pressure, therefore requiring interventional surgery. Interventions

for craniosynostosis are covered by specialist commissioning arrangements.

Positional plagiocephaly, however, has not been shown to be associated with any

long term developmental problems and its treatment has been described as entirely

cosmetic.








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Policy statement: Repair of ear lobes


This will be routinely funded for primary suture post trauma e.g. the patient is

automatically eligible for emergency treatment when he/she presents for repair at

A&E at the time of trauma.

Post emergency applications will only be considered on an exceptional basis.










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Policy statement: Reversal of Sterilisation (Male and Female)


Policy:

Reversal of sterilisation (both male and female) is considered a low priority treatment

and will not normally be provided under the NHS. Sterilisation is provided under the

NHS on the understanding that it is an irreversible procedure. Patients are informed

and written consent is sought before the operation is carried out. Trust clinical

governance systems should continue to embrace good practice guidelines from the

Royal Colleges regarding the giving of information and informed consent prior to

sterilisation

Definition:

Sterilisation is a procedure by which a person is rendered permanently unable to

produce children. This is called a vasectomy in men and operative occlusion of

the fallopian tubes in women. Reversal of sterilisation is a surgical procedure that

involves the reconstruction of the fallopian tubes in women and vas deferens in

men.

Resource implications:

This policy does not change current practices; therefore, the resource implications

remain unchanged.

GLOSSARY (ref 4)

Occlusion: Closing or obstruction of a duct, hollow organ or

blood vessel.

Fallopian Tubes: (or uterine tubes) tubes, one on each side, lying in

the pelvic area of the abdomen, which are attached

at one end to the uterus and have the other


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unattached, but lying close to the ovary.

Vas deferens: A narrow tube that leads from each testicle

References:

1. Royal College of Obstetricians and Gynaecologists. Guideline summary – Male and Female Sterilisation, February 1998 www.rcog.org.uk

2. Grew R. Reversal of sterilisation. North Essex Health Authority low priorities policy, 18th February 1999.

3. Dorland’s Illustrated Medical Dictionary. 40th Edition. A & C Black. London 2002.







http://www.rcog.org.uk/


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Policy statement: Rhinophyma

Status: Threshold

The first-line treatment of the nasal skin condition is medical. Severe cases or those

that do not respond to medical treatment may be considered for surgery or laser

treatment.

Requirements for approval

A standard size photograph showing the whole face








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Policy statement: Scar Revision


Funding will not be available for:

Keloid scars on parts of the body other than the face (see below)

Keloid scars secondary to body piercing procedures Funding may be available via individual prior approval for: [In all cases, medical photography will be required for the individual prior approval]

Scars as a result of self-harm These are very difficult to treat and usually the only achievable outcome is to make the scars resemble trauma or burns rather than be obviously due to self- harm. Treatment will only be funded when there has been a minimum period of three years where there has been no self-harm and where there is a supporting report from a psychiatrist indicating that the behaviour would be unlikely to recur.

Scars secondary to trauma/accidents

Scars on the face that are ragged, or can otherwise be regarded as particularly disfiguring will be funded.

Scars on the rest of the body. Scar revision for cosmetic purposes will not be funded unless the disfigurement can be regarded as particularly grave. Cases will be judged on an individual basis.

Other

Keloid scars that result in physical distress due to significant pain or pruritis

Significant keloid scarring on the face

Scars that are resulting in physical disability due to contraction, tethering or recurrent breakdown will be funded.

Scar revision will only be offered after 2 years to allow the natural healing process to complete. All patients who are smokers should be referred to smoking cessation services at the initial assessment appointment.








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Policy statement: Scotopic Sensitivity Syndrome (Mears-Irlen

Syndrome and Coloured Filters/Tinted Lenses


Policy: Provision of coloured filters/tinted lenses for specific reading difficulty (SRD) is not normally funded

Definition: The most common specific learning difficulty is specific reading difficulty (SRD). Developmental dyslexia or specific learning difficulty for reading has been defined as attainment of reading skills below normal for age, in the presence of normal intelligence, and adequate learning opportunities. In 1983 Irlen described Scotopic Sensitivity Syndrome which was said to cause visual discomfort in a subgroup of people with dyslexia. It consisted of six major categories of symptoms:

Photophobia: sensitivity to light

Background distortion

Visual resolution: the inability to see print clearly and free from distortions

Scope of focus: the inability to perceive groups of letters, notes, numerals, or words at the same time

Sustained focus: the inability to maintain focus except with the employment of inordinate energy and effort

Depth perception/gross motor activities: the inability to judge distance accurately

Sufferers from SSS were diagnosed by a set of questions constituting the Irlen Differential Perceptual Schedule (IDPS) test and treated with coloured lenses specific to each individual.

Priority: Pending further high quality research, provision of coloured filters/tinted lenses for specific reading difficulty (SRD) will not be funded.








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Policy statement: Septoplasty and Rhinoplasty


Septoplasty should be funded for:

Problems caused by obstruction of the nasal airway amenable to the procedure

Deviated nasal septum

Rhinoplasty should be funded for:

Significant nasal deformity caused by trauma

Part of reconstructive head and neck surgery

Correction of complex congenital conditions e.g. cleft lip and palate

Patients with isolated airway problems, in the absence of visible nasal deformity, should be referred initially to an ENT consultant for assessment and treatment. Prior approval is NOT needed for rhinoplasty in instances of trauma or when patients are being treated as an emergency.









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Policy statement: Skin Contouring


Buttock lifts, thigh lifts and arm lifts (brachioplasty), procedures will only be funded in

exceptional circumstances.










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Policy statement: Sleep Apnoea

Status: Individual prior approval

If sleep apnoea is suspected, one or more criteria must be present prior to referral to the sleep unit.

1) Daytime sleepiness (rather than tiredness) assessed by Epworth score (>10)

And one or more of the following:

2) Witnessed regular or frequent nocturnal apnoeic episodes of stopping breathing 3) Waking with sensations of choking/obstruction 4) Neck circumference 17ins or over 5) Significant retrognathia 6) Small oedematous pharynx on visual inspection

Patients referred for sleep studies should also have a nasendoscopic assessment of their upper airways to exclude any structural cause for obstruction

Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed as per the CCG policy. A copy of the completed Epworth Score Questionnaire must be submitted.







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Policy statement: Snoring – ENT consultation


Surgical treatment for simple snoring is considered a low priority and will not

normally be funded. Patients with simple snoring should be advised on lifestyle

modifications without referral to secondary care.

Where snoring is complicated by episodes of breathing cessation please refer to the

Sleep Apnoea Policy.

If clinical assessment suggests a serious underlying pathology rather than simple

snoring a referral for an assessment will be funded. A serious underlying pathology

could include, but is not limited to the following:

Abnormal structure within the upper airways

Neurological causes

Tumours of the post nasal space In circumstances where a cancer is suspected, the 2 week wait referral process

should be used.








Policy statement: Spinal Cord Stimulation

Status: Threshold

Version: 2

Version Control:

Version Number Reason for Amendment Author Date

2 To Align with NICE TA159

guidance

Jennifer L Y Yip

Policy:

Spinal cord stimulation is recommended as a treatment option for adults with chronic pain of

neuropathic origin who:

continue to experience chronic pain (measuring at least 50 mm on a 0–100 mm visual

analogue scale) for at least 6 months despite appropriate conventional medical

management, and

Who is under the care of a specialist multidisciplinary pain team who have recommended

referral for spinal cord stimulation treatment, and

who have had a successful trial of stimulation as part of the assessment by a

multidisciplinary team experienced in chronic pain assessment and management of people

with spinal cord stimulation devices, including experience in the provision of ongoing

monitoring and support of the person assessed.

Patients with chronic pain of ischaemic origin are excluded from spinal cord stimulation

except in the context of research as part of a clinical trial. Such research should be designed

to generate robust evidence about the benefits of spinal cord stimulation (including pain

relief, functional outcomes and quality of life) compared with standard care.

The spinal cord stimulation must be provided at a centre which meets the following criteria

and make the following assessments:

A multidisciplinary pain management team experienced in chronic pain assessment and

management of people with spinal cord stimulation devices, including experience in the

provision of ongoing monitoring and support of the person assessed.

Patients scheduled for spinal cord stimulation should be screened for methicillin-resistant


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Staphylococcus aureus less than four weeks before the procedure to allow rational choice of

antibiotic prophylaxis at the time of surgery.

When assessing the severity of pain and the trial of stimulation, the

multidisciplinary team should be aware of the need to ensure equality of

access to treatment with spinal cord stimulation. Tests to assess pain and

response to spinal cord stimulation should take into account a person’s

disabilities (such as physical or sensory disabilities), or linguistic or other

communication difficulties, and may need to be adapted.

If different spinal cord stimulation systems are considered to be equally

suitable for a person, the least costly should be used. Assessment of cost

should take into account acquisition costs, the anticipated longevity of the

system, the stimulation requirements of the person with chronic pain and the

support package offered.

People who are currently using spinal cord stimulation for the treatment of

chronic pain of ischaemic origin should have the option to continue treatment

until they and their clinicians consider it appropriate to stop.

Implanting centres should audit their spinal cord stimulation activity and

provide patients with information on outcomes and complications.

Implanting centres should report specific devices used and demonstrate

clinical effectiveness, cost effectiveness and quality of their choice.

Clinical need Pain that persists for more than several months, or beyond the normal course of a disease

or expected time of healing, is often defined as chronic. This pain becomes a significant

medical condition in itself rather than being a symptom. Chronic pain can affect people of all

ages, although in general, its prevalence increases with age. Estimates of the prevalence of

this condition in the UK vary from less than 10% to greater than 30% depending on the

specific definition of chronic pain used. Chronic pain is accompanied by physiological and

psychological changes such as sleep disturbances, irritability, medication dependence and

frequent absence from work. Emotional withdrawal and depression are also common, which

can strain family and social interactions.

Standard Treatment: The goal of treatment for chronic pain is to make pain tolerable and to improve functionality

and quality of life. It may be possible to treat the cause of the pain, but usually the pain

pathways are modulated by a multidisciplinary approach (described as conventional medical

management [CMM] in this document). This may include pharmacological interventions such

as non-steroidal anti-inflammatory drugs, tricyclic antidepressants, anticonvulsants,

analgesics and opioids. Non-pharmacological interventions, such as physiotherapy,

acupuncture, transcutaneous electrical nerve stimulation and psychological therapies, can

also be a part of CMM. For some chronic pain conditions there may also be condition-

specific treatments; for example, people with FBSS may have a repeat operation. People

with chronic pain may continue to experience pain despite CMM, and complete relief is


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rarely achieved. The technology:

Spinal cord stimulation (SCS) is a treatment for chronic pain that is usually considered after

standard treatments (such as those listed above) have failed. SCS modifies the perception

of neuropathic and ischaemic pain by stimulating the dorsal column of the spinal cord. SCS

is minimally invasive and reversible. A typical SCS system has four components.

A neurostimulator that generates an electrical pulse (or receives radio frequency pulses) –

this is surgically implanted under the skin in the abdomen or in the buttock area.

An electrode(s) implanted near the spinal cord either surgically or percutaneously (the latter

via puncture, rather than through an open surgical incision, of the skin). A lead that connects the electrode(s) to the neurostimulator.

A remote controller that is used to turn the neurostimulator on or off and to adjust the level of

stimulation.

Rationale: Spinal cord stimulation was recommended for funding using the guidance outlines above in

NICE TA 1591. The Department of Health has directed that the NHS should provide funding

for NICE TA recommended medicines and treatments within three months, unless instructed

by the Secretary of State. New evidence was reviewed by the NICE General Executive in November 2013, and it was

found that the new evidence supported the recommendations in TA1592. The guidance has

been transferred to the static guidance list, until such time when new evidence is made

available.

Referral Process: All referrals/requests should be sent on the Spinal Cord Stimulation

Surgical Threshold Checklist to:

Special Cases Co-ordinator

West Essex CCG

Building 4, Spencer Close

St Margaret’s Hospital

The Plain

Epping

CM16 6TN

Tel: 01992 566140


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Fax: 01992 566148

REFERENCES:

1. NICE TA 159 October 2008

2. NICE TA 159 review decision February 2014

Patients who are not eligible for treatment under this policy may be considered on an

individual basis where their GP or consultant believes exceptional circumstances exist that

warrant deviation from the rule of this policy. Individual cases will be reviewed as per the

CCG policy.

Approved by (committee) Health and Care Commissioning Committee


Produced by (Title); Specialist Registrar in Public Health

Review date: June 2015

Glossary

Ischaemic pain pain associated with decreased blood flow caused by mechanical

obstruction, or insufficient blood flow that results from injury or

surgical trauma.

Neuropathic pain pain caused by a problem with one or more nerves themselves.

The function of the nerve is affected in a way that it sends pain

messages to the brain. Neuropathic pain is often described as

burning, stabbing, shooting, aching, or like an electric shock.


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Spinal Cord Stimulation Surgical Threshold Checklist

Patient Details

Name:

Hospital Number: NHS Number:

Date of Birth:

Address: Postal Code:

Telephone Number:

Clinician Details

Name of Referring

Clinician:

Referrer's Address or

Stamp: Postal Code:

Referrer's Telephone

Number:

Referrers Email

Address:

Name of Trust being

Referred to:

Criteria Checklist - patients should meet the following criteria: tick boxes as appropriate

A

Patients should meet the following criteria

Patient has chronic pain of neuropathic origin


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AND continues to experience has chronic pain ( measuring at least 50mm on a visual analogue scale of

0-100 mm) for at least 6 months despite appropriate conventional medical management

AND is under the care of a specialist multidisciplinary pain team who has referred the patient for spinal

cord stimulation

AND patient has had a successful trial of spinal cord stimulation as part of multidisciplinary assessment

by a team experienced in chronic pain assessment assessment and management of people with spinal

cord stimulation devices, including experience in the provision of ongoing monitoring and support of the

person assessed.

AND diagnosis of ischaemic pain has been excluded

Additional Information

Significant Medical history

Current medication

Other relevant information


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BACK TO INDEX

Form completed by:

Title:

Authorising Signature:

Dated:


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BACK TO INDEX

Policy statement: Tattoo Removal


The funding for removal of tattoos will be considered in the following circumstances:

Funding may be considered for tattoos inflicted under duress during adolescence. In

such instances, tattoo removal will only be considered where the tattoo is on the face

or visible parts of the body and in unusual circumstances where the tattoo causes

marked limitations of psychosocial function. Psychiatric/psychological reports will

need to be provided with the initial referral.










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Policy statement: Temporomandibular Joint Replacement


Temporomandibular Joint Replacement should be considered a LOW PRIORITY

due to limited evidence of clinical effectiveness. Exceptional cases may be

considered by the CCG.

Criteria:

The affected patients usually have severe disease of the temporomandibular joint which may be more serious if patients cannot open their mouths adequately, as dentistry, anaesthesia and resuscitation may be severely complicated and even life-threatening. In such rare cases, TMJ replacement may be considered.

Contraindications:

1) Active or chronic infection 2) Patient conditions where there is insufficient quantity or quality of bone to

support the components 3) Systemic disease with increased susceptibility to infection 4) Patients with extensive perforations in the mandibular fossa and/or bony

deficiencies in the articular eminence or zygomatic arch that would severely comprise support for the artificial fossa component

5) Partial TMJ joint reconstruction 6) Known allergic reaction to any materials used in the components; patients

with mental or neurological conditions who are unwilling or unable to follow post-operative care instructions

7) Skeletally immature patients 8) Patients with severe hyper-functional habits (e.g. Clenching, grinding etc.).

Rationale

There is limited evidence of effectiveness for this procedure. There are no RCTs, no agreed diagnostic classification scheme or universally accepted outcome measures or evidence on the relative cost effectiveness of total TMJ replacement. The research community in the USA have expressed caution about using irreversible surgery for TMJ disorders.

In rare cases of patients with extremely severe cases of TMJ disorder with re- ankylosis who cannot open their mandible and who are at great risk from failure to maintain the airway, there may be a case for total TMJ replacement. If this surgical service development were to proceed then it must be on condition that all patients


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should give full informed consent and be included in a national register using valid outcome measures. The surgery should only be offered by specialist reconstructive maxillo-facial units.

Smoking status of all patients undergoing procedures in secondary care:

Patients should be aware their smoking status will need to be determined, where relevant in all those being referred to secondary care for treatment. If funding is approved, patients should be aware that the CCG has a policy of ‘Stop Before the Op’, which means patients must be non-smoking for a minimum period of 8 weeks prior to any operation taking place. Support is available through the Health Promotion Team to help patients stop smoking.

BMI:

All non-urgent patients with a BMI above 30 should be offered advice and support by their GP to help them lose weight.

References:

American Society of Temporomandibular Joint Surgeons: Guidelines for Diagnosis and Management of Disorders Involving the Temporomandibular Joint and Related Musculoskeletal Structures Dec 2000. Accessed Jul 10, 2006. http://www.astmjs.org/frame_guidelines.html

Glossary: Temporomandibular Joint:

Mandibular Fossa

Zygomatic Arc

The hinge joint of the lower jaw A depression in the temporal bone in which the

condyle of the mandible rests.

The part of the temporal bone of the skull that

forms the prominence of the cheek.







http://www.astmjs.org/frame_guidelines.html

http://www.astmjs.org/frame_guidelines.html


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Policy statement: Tonsillectomy

Status: Threshold

Patients with lymphoma or cancer of the tonsil are excluded from this policy. Criteria Tonsillectomy is funded for the following indications:

1. Tonsillectomy for the treatment of Recurrent Tonsillitis or it’s complications, patients must meet the following criteria:

significant sore throat due to tonsillitis AND

the episodes of tonsillitis are disabling and prevent normal functioning AND

seven or more well documented, clinically significant, adequately treated episodes in the preceding year

OR

five or more such episodes in each of the preceding two years OR

three or more such episodes in each of the preceding three years. OR

Peritonsillar abscess (quinsy)

2. Sleep apnoea in children <16 years old:

Diagnosis to be confirmed through history, examination and investigations (sleep study) where appropriate

Documented large tonsils with or without nasal obstruction

3. Patients with specific clinical conditions or syndromes, who require tonsillectomy as part of their on-going management strategy:

Psoriasis

Nephritis

PFAPA syndrome (Periodic Fever, Aphthous Stomatitis, Pharyngitis, Adenitis Syndrome)


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Rationale

This policy has been developed using the criteria within the Royal College of Surgeons commissioning guide for tonsillectomy. Evidence for the benefits of tonsillectomy is poor. In children surgery may be beneficial in selected cases. In adults, limited evidence suggests that tonsillectomy may benefit people with recurrent infection. (NICE evidence summaries). The potential benefits of tonsillectomy in reducing recurrent or chronic throat infection need to be weighed against complications and operative risks and the possibility that the throat infections may resolve without intervention (watchful waiting). A period of watchful waiting is more appropriate for children with mild sore throats (SIGN 2010). The Royal College of Surgeons advise that before referral to secondary care a discussion should take place of the benefits and risks of tonsillectomy vs. watchful waiting for both recurrent tonsillitis and sleep disordered breathing. Information to be provided and reassurance given if no further treatment or referral for tonsillectomy is deemed necessary at this stage. This discussion should be documented (Royal College of Surgeons 2013). For recurrent tonsillitis in children <16 years old the Right Care Shared Decision Aid for recurrent sore throats should be used before referral into secondary care (http://sdm.rightcare.nhs.uk/pda/). Information to be provided and reassurance given if no further treatment or referral for tonsillectomy is deemed necessary at this stage. This discussion should be documented (Royal College of Surgeons 2013). The impact of recurrent tonsillitis on a patient’s quality of life and activities of daily living should be taken into consideration. A fixed number of episodes, as described above, may not be appropriate for adults with severe or uncontrolled symptoms, or if complications (eg quinsy) have developed (Royal College of Surgeons 2013). There is a lack of published evidence demonstrating the benefit of performing tonsillectomy for the treatment of tonsilloliths (evidence review April 2015) and therefore this has not been included as an indication for tonsillectomy. References Scottish Intercollegiate Guidelines Network. (2010) Management of sore throat and indications for tonsillectomy. (SIGN Guideline No 117). [online] Available from http://www.sign.ac.uk/pdf/sign117.pdf [accessed 6 January 2015] NICE Clinical Knowledge Summaries. Evidence for tonsillectomy. [online] Available from http://cks.nice.org.uk/sore-throat-acute#!supportingevidence [accessed 14 January 2015] Royal College of Surgeons Tonsillectomy Commissioning Guide. 2013 [online] Cochrane Review. Decision aids for people facing health treatment or screening decisions. (2014) Wiley Online Library [online] Available from http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001431.pub4/abstract [accessed 7 April 2015]

http://sdm.rightcare.nhs.uk/pda/

http://www.sign.ac.uk/pdf/sign117.pdf

http://cks.nice.org.uk/sore-throat-acute#!supportingevidence

http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001431.pub4/abstract


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Right care. Shared Decision Aid for Recurrent Sore Throat. [online] Available from http://sdm.rightcare.nhs.uk/pda/recurrent-sore-throat/ Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed as per the CCG policy


West Essex Health and Care Committee


Produced by (Title): Clinical Commissioner


http://sdm.rightcare.nhs.uk/pda/recurrent-sore-throat/


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Policy statement: Trigger Finger

Status: Threshold

Referrals for surgery for trigger finger will only be funded for patients who have

fulfilled the criteria as follows:-

failure to respond to conservative measures [e.g. up to 2 hydrocortisone

injections], AND

where the patient has a fixed* deformity that cannot be corrected.

*Fixed: - “attached or placed so as to be immovable; not subject to change”








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Policy statement: Varicose Vein Surgery

Status: Threshold

Treatment for varicose veins will not normally be offered for cosmetic reasons.

Surgery for varicose veins is considered to be a low priority and will only be provided

under the NHS to patients suffering from one or more of the following:

Criteria:

Unsuccessful use of compression stockings for 3 month duration, where this is considered an appropriate part of the management plan.

AND one or more of the following:

Obvious or severe skin changes, including significant varicose eczema, lipodermatosclerosis, moderate to severe oedema

Ulceration

Recurrent phlebitis

Bleeding from a varicose vein

AND

Chronic venous insufficiency assessed by a Hospital Consultant.

Definition: Varicose veins are dilated superficial veins in the leg caused by incompetent valves which

allow high pressure blood to reflux from the deep veins impairing the venous circulation of

the leg.

Estimated number of people affected: Varicose veins more commonly affect women than men; the prevalence in the UK was 31%

in women and 17% in men in a London study. Prevalence increases consistently with

increasing age. In Wales, a study found that 25% of women aged between 25-34 suffered

from varicose disorders, compared to 66.6% of women over 55 years.

Evidence: There is little evidence on cost effectiveness of surgery and sclerotherapy compared to other

elective surgical procedures. NICE’s Interventional Procedure guidance 37, published in

January 2004, concluded transillumination powered phlebectomy for varicose veins, should

not be used without special arrangements for consent, audit and research.


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However, the Interventional Procedure guidance 52 (published in March 2004) concluded

that current evidence on the safety efficacy of endovenous laser treatment of the long

saphenous vein appears adequate to support its use if normal arrangements are in place for

consent, audit and clinical governance. Clinicians considering its use in preference to

existing practice will need to discuss this with their own Trust and with commissioners.

Consideration of subfascial endoscopic perforator vein surgery in IPG 59 published in May

2004, concluded that the efficacy of the procedure is currently unproven and as indications

of the procedure are now well established, careful selection will be particularly important if

the procedure is being considered.

IPG 182 published in June 2006 suggests that current evidence on ultrasound-guided foam

sclerotherapy for varicose veins shoes that it is efficacious in the short term.

However, the evidence on safety indicates that there are transient side effects that suggest

that the procedure should be used with special arrangements for consent, for audit or

research. Also, currently only liquid sclerosants are licensed for the treatment of varicose

veins. The method used to mix liquid sclerosant with air and the size of the foam bubbles

used may influence safety.

Health benefits: Treatment for significant varicose veins may improve quality of life. Studies indicate that this

improvement is more likely to be short-term rather than long-term.

Risks: There is a chance of complications associated with, either during or following surgical

interventions.

Priority: Surgery for varicose veins is considered a low priority treatment and will only be provided

under the NHS in line with the guidelines specified above. Other cases will be reviewed on

an individual case basis.

GLOSSARY (ref 3)

Eczema: Symptoms typically include itching, dryness or cracking and

occasionally soreness of the skin.

Lipodermatosclerosis: Means hardening of the fat layer of the skin.

Oedema: Means an abnormal accumulation of fluid beneath the skin, or in

one or more of cavities of the body.

Phlebitis: Means inflammation of a vein.


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Sclerotherapy: A treatment that involves injecting varicose veins with a

sclerosing fluid. This causes fibrosis of the lining of the vein and

its eventual obliteration.

Subcutaneous: Means anything pertaining to the loose cellular tissue beneath

the skin.

Venous Insufficiency: Normally blood flows from the subcutaneous tissues to the

superficial veins which drain via perforating veins into the deep

veins of the leg. This flow, back towards the heart, is aided by

valves within the veins. When the valves fail this is called

venous insufficiency. This results in increased pressure within

the vessels leading to dilation known as varicose veins.

References:

18. Robbins M et al, Varicose Vein Treatment in Health Care Needs Assessment: The Epidemiologically Based Needs Assessment Reviews, edited by A Stevens and J Raftery. Oxford Radcliffe Medical Press 1994.

19. London N J M et al. Varicose Veins. BMJ 2000; 320: 1391-1394 (20th May)

20. Black’s Medical Dictionary 38th Edition. A & C Black. London 1997 21. Gaunt ME General Surgery Outpatient Decisions, chapter 10. Arnold 2000 22. Franks PJ, Wright DD, Moffatt CJ, Stirling J, Fletcher AE, Bulpitt CJ, et all.

Prevalence of venous disease: a community study in West London. Eur J Surg 1992:158:143-7.

23. National Institute for Clinical Excellence. IPG 037 Transilluminated powered phlebectomy for varicose veins.

24. National Institute for Clinical Excellence. IPG 052 Endovenous laser treatment of the long saphenous vein.

25. National Institute for Clinical Excellence. IPG 059 Subfascial endoscopic perforator vein surgery.

26. National Institute for Clinical Excellence. IPG 182 Ultrasound-guided foam sclerotherapy for varicose veins.







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Varicose Veins Referral Guidelines – March 2013

Introduction

Most patients with varicose veins can be managed in primary care. These

guidelines provide graphical illustrations to aid the classification of varicose veins to

ensure appropriate referrals are made to secondary care. These guidelines should

also be read in conjunction with the West Essex service restriction policy relating to

varicose veins.

Commissioning Policy

Treatment for varicose veins will not normally be offered for cosmetic reasons.

Surgery for varicose veins is considered to be a low priority and will only be provided

under the NHS to patients suffering from one or more of the following:

Criteria:

Unsuccessful use of compression stockings for 3 month duration, where this

is considered an appropriate part of the management plan.

AND one or more of the following:

Obvious or severe skin changes, including significant varicose eczema,

lipodermatosclerosis,

moderate to severe oedema

Ulceration

Recurrent phlebitis

Bleeding from a varicose vein

AND

Chronic venous insufficiency assessed by a Hospital Consultant.

Varicose Veins Referral Guidelines

Varicose veins belong to the group of Chronic Venous Disorders (CVD) which

include a spectrum of clinical presentations ranging from uncomplicated

telangiectasias and varicose veins to chronic venous insufficiency (CVI) resulting in

venous ulceration. This document uses the ‘C’ (clinical) class of the CEAP grading

system to classify chronic venous insufficiency (including varicose veins) and

indicate where referral into specialised services may be appropriate:


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Grade C0. No venous disease.

No visible or palpable signs of venous disease.

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Treatment is NOT available in the NHS and patients without visible or palpable signs

of venous disease should NOT be referred to NHS vascular clinics.

Grade C1. Telangiestasia or reticular veins

Red/blue spider veins or flares are all forms of telangiectasia. Reticular veins are

easily visible small blue veins (less than 3mm diameter), not associated with valvular

incompetence of superficial venous trunks (e.g. long or short saphenous veins).

Telangiectasia Telangiectasia and Reticular

Telangiectasia and reticular may be unsightly but are of cosmetic concern only.

Treatment is NOT available in the NHS and patients with such veins should NOT be

referred to NHS vascular clinics.

Grade C2. Varicose Veins

Varicose veins, which have a diameter 3mm (therefore distinguishable from reticular

veins), and may be associated with long or short saphenous valvular incompetence.

Varicose veins may be subdivided into; asymptomatic, uncomplicated and

associated with mild symptoms, or associated with complicating symptoms.

Asymptomatic Varicose Veins

Asymptomatic varicose veins may be associated with long or short saphenous

valvular incompetence but have no associated symptoms. These veins may cause

cosmetic concerns, or needless worries about possible harm they might cause.


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Specialist treatment for patients with asymptomatic varicose veins is NOT available

in the NHS and they should NOT be referred to NHS vascular clinics.

Uncomplicated Varicose veins with symptoms such as pain, aching, heaviness or

itching.

These symptoms are common among people with varicose veins. Varicose veins

may also cause itching (not associated with eczema or skin changes). Other

causes of pains in the legs should be considered: varicose veins do not cause

severe or sharp pains or pain on movement.

Asymptomatic and Uncomplicated Varicose Veins

Specialist treatment is NOT routinely available in the NHS for patients with

uncomplicated varicose veins with mild symptoms and they should NOT normally be

referred to NHS vascular clinics.

Varicose veins with complications, including bleeding and recurrent phlebitis

Patients who have had bleeding associated with varicose veins should be referred

urgently.

Patients with recurrent thrombophlebitis associated with varicose veins may be

referred, especially if phlebitis has affected veins above the knee.


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Thrombophlebitis

Source:

These patients should be referred to a vascular surgical service for consideration of

treatment for their varicose veins. Treatment is available on the NHS.

Grade C3. Oedema

Varicose veins can be associated with chronic lower limb oedema. Where there is mild lower limb oedema associated with varicose veins referral is

NOT normally advised. Where there is moderate/severe lower limb oedema associated with varicose veins

NHS treatment is available and these patients should be referred to a vascular

surgical service.

Grade C4. Obvious or severe changes in skin and subcutaneous tissue

indicating Chronic Venous Insufficiency

This includes those patients with signs of Chronic Venous Insufficiency are at

significant risk of developing Chronic Venous Ulceration and should be referred into

specialised services. They can be further subdivided into:

C4a. Eczema

Patients presenting with varicose veins associated with eczema requiring specific

treatment in order to prevent skin breakdown. This should not include simple itching

without skin changes.

Patients with severe eczema near the ankle or associated with varicose veins below

the knee which endangers tissue viability should be referred for specialist advice.


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Varicose Stasis Gravitational Eczema

C4b. Lipodermatosclerosis or atophie blanche

Patients with lipodermatosclerosis (hardened, tight, red or brown skin, typically

affecting the inner aspect of the calf) or atrophie blanche (star-shaped, ivory white,

depressed, atrophic scars with surrounding pigmentation, often found in areas where

an ulcer has healed) are at risk of developing ulceration.

Lipodermatosclerosis Atrophie Blanche source:

http://www.urgo.co.uk/268-

clinical-signs-of-venous-

disease#c4

Prompt referral is advised and these patients should be given clinical priority in

vascular clinics.

http://www.urgo.co.uk/268-


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Grade C5. Healed Venous Ulcer

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Patients with healed venous ulceration and resulting trophic changes are at

significant risk of developing further ulceration.

Healed Venous Leg Ulcer

Prompt referral is advised and these patients should be given priority on vascular

clinics.

Grade C6. Active venous ulcer

Patients who develop leg ulcers should initially be seen in specialist community-

based ulcer clinics where arterial disease can be excluded and venous ulcers may

then be treated by four layer bandaging.

Most venous ulcers are associated with superficial venous disease and if this is

treated then the risk of further ulceration is reduced. There should therefore be a

low threshold for referring patients with ulcers to a specialist vascular service,

especially if they have arterial disease, painful ulceration or obvious varicose veins.

Active Leg Ulceration


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Exceptions to the Policy

Commissioning, by its very nature, focuses on the high level. However,

Commissioners recognise that every patient is an individual and that there may be

particular circumstances which give grounds for funding treatment in an individual

case contrary to the decision not to fund in general.

To receive exceptional funding for varicose veins at grade 0, I or II, a clinical

advocate for the patient needs to be able to demonstrate that:

The patient is significantly different to the general population of patients with

the condition in question;

And

The patient is likely to gain significantly more health benefit from the

intervention that might be normally expected for patients with that condition.

Applications need to be submitted to the appropriate Exceptional Cases Panel:

Summary Table

CEAP Grade Characteristic Referral Guidance

C1 Telangiectasia / thread veins

Treatment NOT available on NHS, referral NOT advised Reticular veins (3mm)

C2

Asymptomatic Varicose Veins

Treatment NOT available on NHS, referral NOT advised

Uncomplicated Varicose Veins with mild symptoms of pain, aching, heaviness or itching

Treatment NOT routinely available and referral NOT normally advised

Varicose Veins with Complicating symptoms of bleeding and thrombophlebitis

Referral advised

C3

Varicose veins associated with mild oedema

Referral NOT advised

Varicose veins with moderate/severe oedema

Referral advised


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C4a

Severe eczema requiring specific treatment to prevent skin breakdown

Referral advised

C4b Lipodermatosis or atrophie blanche

Prompt referral advised

C5 Previous venous ulceration

Prompt referral advised

C6 Active venous ulceration

Referral advised

References

Varicose Veins Guidance. NHS Devon, NHS Plymouth & Torbay Care Trust. 2011 Eklof B, Rutherford RB, Bergan JJ et al. Revision of the CEAP classification for

chronic venous disorders: Consensus statement. J Vasc Surg 2004; 40: 1248-52.

http://www.cks.nhs.uk/venous_eczema_and_lipodermatosclerosis#340892004 NHS

Evidence Knowledge Summaries. Lipodermatosclerosis

Berridge B, Bradbury W, Davies A et al. Recommendations for the referral and

treatment of patients with lower limb chronic venous insufficiency (including varicose

veins). Venous Forum of the Royal Society of Medicine. 2010

http://www.cks.nhs.uk/venous_eczema_and_lipodermatosclerosis#340892004


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Policy statement: Vasectomy Secondary Care


Policy:

Vasectomy will not be funded in secondary care unless there are exceptional

medical circumstances. The exceptional medical circumstances will be considered

on a case by case basis by the Exceptions Case Panel of West Essex CCG.

Definition: Vasectomy is a surgical procedure to cut and seal off the two tubes (vas deferens)

that carry sperm from the testicles to the penis, thus rendering the patient sterile.

Vasectomy should be considered irreversible and permanent.

Resource implications: This policy clarifies current practice and therefore the resource implications remain

unchanged.

Priority: This is a low priority treatment.







ASH Fact Sheet on Smoking and surgery Planned review date: August 2016

IntroductionIn addition to the general health risks associated with smoking, research has shown that smokers are also more likely to suffer complications during and following surgery.1 2 3 The Royal College of Anaesthetists (RCoA) advises smokers undergoing surgery to quit for several weeks before their surgery in order to reduce the risk of breathing problems.4 Smokers who are unable to quit smoking are advised to refrain from smoking on the day of the operation.4 Smokers undergoing cosmetic surgery are advised to refrain from smoking for at least two weeks before and after the operation to improve post-operative recovery.5

Risks associated with smoking and surgerySome surgeons will not perform surgery on patients who smoke6 7 and the RCoA considers quitting smoking to be essential before undergoing heart surgery. There is some research which suggests that smokers who have been smoking for longer than ten years should not undergo breast reconstructive surgery as the risk of complications is so high.8

There is strong evidence that smokers who undergo surgery: have a higher risk of lung and heart complications• 9 10 11

have higher risk of post-operative infection• 12 13 14

have impaired wound healing• 15 16 17 18

are more likely to be admitted to an intensive care unit• 19

have an increased risk of dying in hospital• 20 21

are at higher risk of readmission• 22

remain in hospital longer.• 23

A prospective cohort study from the United States found that smoking was associated with an almost sixfold increased risk for post-operative pulmonary complications.23 Smoking is the single most important risk factor for the development of serious post-operative complications in patients undergoing elective hip and knee replacement19 24 as well as the single most important factor for the development of post-operative cardiopulmonary and wound-related complications in elective orthopaedic surgery.25 Smoking has pronounced effects in foot and ankle surgery, resulting in higher rates of complications, particularly non-union.26 Smoking is also an important predictive factor for anastomotic leakage after colonic and rectal resection27 and smokers are at significantlyhigherriskofcomplicationsduringreconstructivebreastsurgeryandbreastcancersurgery.28 29

A function of anaesthesia is to reduce coughing and spasms during surgery but because smokers are more prone to coughing during surgery they need a higher dose of anaesthesia than non-smokers.30 Also, smokers have decreased blood oxygenation, leading to decreased oxygen delivery to their tissues31 and are consequently more likely to need oxygen therapy. Depriving vital organs of oxygen for even a short period of time can lead to serious complications.

Smoking and surgery

March 2014

29

ASH Fact Sheet on Smoking and surgery2

Benefits of quitting before surgeryThere is evidence to suggest that quitting smoking before having surgery:

reduces the risk of post-operative complications• 32

reduces lung, heart and wound-related complications• 33 34 decreases wound healing time• 35

reduces bone fusion time after fracture repair• 36

reduces length of stay in hospital.• 23

This is in addition to the long-term benefits of quitting smoking such as reduced risk of lung cancer and heart disease.

Evidence about the optimum time to quit smoking prior to surgery varies, with most research finding that two months prior to surgery provides the most benefit.37 38 39 40 For smokers who are unable to quit, the Royal College of Anaesthetists advises that they should at least refrain from smoking on the day of surgery to help avoid breathing problems during the procedure.4

There is some older evidence which suggests that stopping smoking shortly before surgery may increase complications.41 However, independent research investigating this question found no increased risk in pulmonary complications amongst smokers who quit just before surgery42 and a 2011 review found no increase in complications amongst smokers who quit within two months of surgery.43

Smokers who are concerned should seek advice from their surgeon, or preferably the anaesthetist who will be with them during surgery.

Quitting smoking after surgery also brings significant benefits. A 20 year follow-up study of smokers who underwent coronary artery bypass graft surgery found that smoking cessation after surgery was an important independent predictor of a lower risk of death and repeat coronary procedures compared with patients who continued smoking.44

Costs to the NHSThe health problems associated with smoking have been estimated to cost the NHS around £2.7 billion every year45 while other estimates have put the cost as high as £5.2 billion.46 This does not include the cost of work days lost, sickness benefits and other indirect costs.

It has been estimated that, in London alone, savings of around £2,650,000 a year could be made if between 8% and 17% of smokers quit before having surgery.47 The Welsh government has estimated that supporting smokers to quit before having surgery smokers could save as much as £2.3 million more every year.48 These savings are derived from “bed days” saved and the reduced cost of treating post-operative complications.

Stop Smoking Advice for smokers undergoing elective surgeryResearch in the USA found that many surgeons and most anaesthetists do not routinely counsel prospective patients to quit smoking prior to surgery, (42% and 70% respectively).49 In the UK, the National Institute for Health and Care Excellence (NICE) recommends that “patients referred for elective surgery should be encouraged to stop smoking before an operation” and that services should be developed to assist them.50 51

Evidence suggests that smoking cessation programmes aimed at assisting smokers undergoing surgery to quit are effective at reducing post-operative complications52 53 and intensive interventions which begin during the hospital admission are especially effective.54 A hospital admission may boost a person’s receptivity to smoking cessation interventions and increase


their motivation to stop smoking.55

Provision of Stop Smoking Services for prospective surgical patients in the UK has increased in recent years. Some hospitals offer brief intervention counselling for smokers or provide information during surgical pre-admission checks56 57 while others write to all prospective surgical candidates about the risks associated with smoking and surgery with contact details for local stop smoking services and a number have produced leaflets for patients58 59 or provide information on their websites.60


References

1 Theadom A, Cropley M. Effects of preoperative smoking cessation on the incidence and risk of intraoperative and postoperative complications in adult smokers: a systematic review. Tobacco Control, 2006; 15: 352–8.2 Azodi OS, Belloco R, Eriksson K, et al The impact of tobacco use and bodymass index on the length of stay in hospital and the risk of post-operative complications among patients undergoing surgery. Journal of Bone and Joint Surgery, 2006: (88B) 10:1316-1320. 3 Jones RM. Smoking before surgery: the case for stopping. British Medical Journal, 1985; 290: 1763-1764. 4 Royal College of Anaesthetists leaflet. You and your anaesthetic. Royal College of Anaesthetists, May 2008.5 Cosmetic Surgery Consultants website. “Smoking and Cosmetic Surgery”. Accessed 9 Jun. 2013.6 Ishikawa SN, Murphy GA, Richardson EG. The effect of cigarette smoking on hindfoot fusions. Foot Ankle International, 2002; 23 (11): 996–8.7 Cosmetic Surgery Consultants website. “Smoking and Cosmetic Surgery”. Accessed 9 Jun. 2013.8 Chang DW, Reece GP, Wang B, Rob G et al. Effect of smoking on complications in patients undergoing free TRAMflapbreastreconstruction. Plastic and Reconstructive Surgery, 2000.105. 7: 2374-2380.9 Møller AM, Pedersen T, Villegro N. Effect of smoking on early complications after elective orthopaedic surgery. Journal of Bone and Joint Surgery 2003; (85-B) 178 – 81.10 Walker NM, Morris SAC, Cannon LB. The effect of pre-operative counselling on smoking patterns in patients undergoing forefoot surgery. Foot and Ankle Surgery, 2009; 15: 86 – 89. 11 Petrar S, Bartlett C, Hart RD, MacDougall P. Pulmonary complications after major head and neck surgery: a retrospective cohort study. The Laryngoscope, 2012. 12. 5: 1057-106112 Jorgensen LN, Kallchave F, Christensen E, et al. Less collagen production in smokers. Surgery, 1998; 123:450–5.13 Jones RM. Smoking before surgery: the case for stopping. BMJ, 1985; 290: 1763-1764.14 Sørensen LT, Horby J, Friis E, Pilsgaard B et al. Smoking as a risk factor for wound healing and infection in breast cancer surgery. European Journal of Surgical Oncology. 2002. 28. 8: 815-82015 Jones JK, Triplett RG. The relationship of cigarette smoking to impaired intraoral wound healing: a review of evidence and implications for patient care. J Oral Maxillofac Surg, 1992; 50:237-9. 16 Silverstein P. Smoking and wound healing. American Journal of Medicine, 1992; 93 (1A):22S-24S. 17 Sørensen LT, Horby J, Friis E, Pilsgaard B et al. Smoking as a risk factor for wound healing and infection in breast cancer surgery. European Journal of Surgical Oncology, 2002. 28. 8: 815-820. 18 Sørensen LT. Wound healing and infection in surgery: the clinical impact of smoking and smoking cessation: a systematic review and met-analysis. Arch Surg, 2012. 147. 4: 373-383.19 Møller AM, Maaloe R, Pedersen T. Post-operative intensive care admittance: the role of tobacco smoking. Acta Anaesthesiol Scand, 2001; 45:345-8. 20 London Health Observatory. Stop before the op. LHO and SmokeFree London, 2006.21 Delgado-Rodriguez M, Medina-Cuadros M, Martinez-Gallego G, Gomez-Ortega A et al. A prospective study of tobacco smoking as a predictor of complications in general surgery. Infection control and hospital epidemiology, 2003, 24. 1: 37-4322 Myers K, Hajek P, Hinds C, McRobbie H. Stopping smoking shortly before surgery and postoperative complications. Archive of Internal Medicine, 2011. 171. 11: 983-98.

23 London Health Observatory. Stop before the op. LHO and SmokeFree London. 24 Kotani N, Hashimoto H, Sessler DI, et al. Smoking decreases alveolar macrophage function during anaesthesia and surgery. Anesthesiology, 2000; 92:1268-77. 25 Møller AM, Pedersen T, Villegro N. Effect of smoking on early complications after elective orthopaedic surgery. Journal of Bone and Joint Surgery, 2003; (85-B) 178 – 81.26 Ishikawa SN, Murphy GA, Richardson EG. The effect of cigarette smoking on hindfoot fusions. Foot Ankle Int, 2002; 23 (11): 996–8.27 Sørensen LT, Jørgensen T, Kirkeby LT, Skovdal J et al. Smoking and alcohol abuse are major risk factors for anastomotic leakage in colorectal surgery. British Journal of Surgery, 1999. 86.7: 927-931.28 Chang DW, Reece GP, Wang B, Rob G et al. Effect of smoking on complications in patients undergoing free TRAMflapbreastreconstruction. Plastic and Reconstructive Surgery, 2000. 105. 7: 2374-2380.29 Sørensen LT, Horby J, Friis E, Pilsgaard B et al. Smoking as a risk factor for wound healing and infection in breast cancer surgery. European Journal of Surgical Oncology, 2002. 28. 8: 815-820.30 Chimbira W, Sweeney BP. The effect of smoking on postoperative nausea and vomiting. Anaesthesia, 2000. 55. 6: 540-544.31 Jensen JA, Goodson WH, Hopf HW. Cigarette smoking decreases tissue oxygen - Arch Surg, 1991; 126: 1131-1134. 32 Moore S, Mills BB, Moore RD, et al. Perisurgical smoking cessation and reduction of postoperative complications. American Journal of Obstetric Gynaecology, 2005; 192: 1718-21.

http://www.rlbuht.nhs.uk/OurHospitals/Pages/Patient%20Leaflets/Anaesthetics%20and%20Theatres/Stop%20Smoking%20Before%20Your%20Operation.aspx



































33 Møller AM, Pedersen T, Villegro N. Effect of smoking on early complications after elective orthopaedic surgery. Journal of Bone and Joint Surgery, 2003; (85-B) 178 – 81. 34 Nakagawa M, Tanaka H, Tsukuma H, Kishi Y. Relationship between the duration of preoperative smoke-free period and the incidence of postoperative pulmonary complications after pulmonary surgery. Chest Journal, 2001. 120. 3: 705-710.35 Sorensen LT, Karlsmark T, Gottrup F. Abstinence from smoking reduces incisional wound infection: a randomized controlled trial. Annals of Surgery, 2003; 238(1): 1-5. 36 Ishikawa SN, Murphy GA, Richardson EG. The effect of cigarette smoking on hindfoot fusions. Foot Ankle Int, 2002; 23 (11): 996–8. 37 Myers K, Hajek P, Hinds C, McRobbie H. Stopping smoking shortly before surgery and postoperative complications. Archive of Internal Medicine, 2011. 171. 11: 983-989.38 Bluman LG, Mosca L, Newman N, Simon DG. Preoperative smoking habits and postoperative pulmonary complications. Chest, 1998. 113 4: 883-889. 39 Khan MA, Hussain SF Pre-operative pulmonary evaluation. J Ayub Med Coll Abbottabad, 2005.17 4: 82- 86. 40 Furlong C Preoperative Smoking Cessation: A Model to Estimate Potential Short-term Health Gain and Reductions in Length of Stay. London Health Observatory, 2005. 41 Warner MA, Offord KP, Warner ME, Lennon RL, et al. Role of preoperative cessation of smoking and other factors in postoperative pulmonary complications: a blinded prospective study of coronary artery bypass patients. Mayo Clin Proc, 1989. 64. 6: 609-616. 42 Barrera R, Shi W, Amar D. Smoking and timing of cessation: impact on pulmonary complications after thoracotomy. Chest, 2005; 127: 1977-1883. 43 Myers K, Hajek P, Hinds C, McRobbie H. Stopping smoking shortly before surgery and postoperative complications. Archive of Internal Medicine, 2011. 171. 11: 983-989. 44 van Domburg RT, Meeter K, van Berkel DFM, Veldkamp RF et al. Smoking cessation reduces mortality after coronary artery bypass surgery: a 20 year follow-up study. Journal American College of Cardiology, 2000. 36. 3. 45 Callum C, Boyle S, Sandford A. Estimating the costs of smoking to the NHS in England and the impact of declining prevalence. Health Economics Policy & Law, 2010. 46 Allender, S. The burden of smoking-related ill health in the UK. Tobacco Control, 2009; 18: 262-267. 47 London Health Observatory. Stop before the op. LHO and SmokeFree London, 2006. 48 Stop Smoking Wales. Asummaryofthehealthimpactofsmokingandshort-termbenefitsofstopping smoking before an operation in Wales. Welsh Assembly Government, 2007. 49 Khullar D, Schroeder SA, Maa J. Helping smokers quit around the time of surgery. JAMA, 2013. 309. 10: 993- 994.50 National Institute for Health and Care Excellence Website “Commissioning a smoking cessation service for people having elective surgery”. Accessed 3 Jun. 2013. 51 National Institute for Health and Care Excellence. Public Health Guidance PH10 on Smoking Cessation Services. Published February, 2008. 52 Lindstrom D et al. Effects of a perioperative smoking cessation intervention on postoperative complications: a randomized trial. Annals of Surgery, 2008; 248: 739-745. 53 Walker NM, Morris SAC, Cannon LB. The effect of pre-operative counselling on smoking patterns in patients undergoing forefoot surgery. Foot and Ankle Surgery, 2009; 15: 86 – 89. 54 Thomsen T, Villebro N & Moeller A. Interventions for preoperative smoking cessation. Cochrane database of Systematic Reviews, 2010 (7). 55 Rigotti NA, Munafo MR, Stead LF. Interventions for smoking cessation in hospitalised patients. Cochrane database of systematic reviews, 2007 (3). 56 Southend Hospital. Accessed 17 May 2013. 57 Bedford Hospital. Accessed 20 Jun. 2013.58 NHS Grampian. Accessed 20 Jun. 2013. 59 University of Southampton Hospital. Accessed 15 May 2013. 60 The Royal Liverpool and Broadgreen University Hospital. Accessed 15 May 2013.






























1

ASA PHYSICAL STATUS CLASSIFICATION SYSTEM

Last approved by the ASA House of Delegates on October 15, 2014

Table 1: Current definitions (NO CHANGE) and Examples (NEW)

ASA PS Classification

Definition Examples, including, but not limited to:

ASA I

A normal healthy patient Healthy, non-smoking, no or minimal alcohol use

ASA II

A patient with mild systemic disease

Mild diseases only without substantive functional limitations. Examples include (but not limited to): current smoker, social alcohol drinker, pregnancy, obesity (30<BMI<40), well-controlled DM/HTN, mild lung disease

ASA III

A patient with severe systemic disease

Substantive functional limitations; One or more moderate to severe diseases. Examples include (but not limited to): poorly controlled DM or HTN, COPD, morbid obesity (BMI ≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, ESRD undergoing regularly scheduled dialysis, premature infant PCA < 60 weeks, history (>3 months) of MI, CVA, TIA, or CAD/stents.

ASA IV

A patient with severe systemic disease that is a constant threat to life

Examples include (but not limited to): recent (<3 months) MI, CVA, TIA, or CAD/stents, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, sepsis, DIC, ARD or ESRD not undergoing regularly scheduled dialysis

ASA V

A moribund patient who is not expected to survive without the operation

Examples include (but not limited to): ruptured abdominal/thoracic aneurysm, massive trauma, intracranial bleed with mass effect, ischemic bowel in the face of significant cardiac pathology or multiple organ/system dysfunction

ASA VI

A declared brain-dead patient whose organs are being removed for donor purposes

*The addition of “E” denotes Emergency surgery: (An emergency is defined as existing when delay in treatment of the patient would lead to a significant increase in the threat to life or body part)

2

Appendix 1 1 2 References related to use of the ASA PS Classification System 3 1. Guidelines for the use of Sedasys by non-anesthesia trained proceduralist and nurse. 4

http://www.sedasys.com/ 5 2. American College of Surgeons’ proposed guidelines for care of pediatric surgical patients. 6

Journal of the American College of Surgeons, 2014;218:479-48 7 3. Guidelines for local anesthesia cases in a major academic center. “Monitoring patients 8

receiving local anesthesia”, MGH, Perioperative Nursing, OR L. 16 9 4. Office Based Procedure guidelines 10

https://phpmm.org/Portals/79/WebFiles/Provider%20Manual%20Updates/Clinical%20Guidel11 ines/MQIC%202009%20Office-Based%20Surgery%20Guideline.pdf 12

5. Preoperative testing guidelines. http://www.choosingwisely.org/doctor-patient-lists/american-13 society-of-anesthesiologists/ 14

15 Appendix 2 16 17 Selected References Addressing Inter-Rater Reliability of the ASA PS Classification System 18 1. Owens WD, Felts JA, et al. ASA physical status classifications: A study of consistency of 19

ratings. Anesthesiology. 1978;49:239–43 (Editorial by Keats AS. The ASA Classification of 20 Physical Status – A Recapitulation. Anesthesiology 1978;49:233-6) 21

2. Haynes SR, Lawler PG. An assessment of the consistency of ASA physical status 22 classification allocation. Anaesthesia. 1995;50:195-9 23

3. Mak PH, Campbell RC et al. The ASA physical status classification: inter-observer 24 consistency. Anaesth Intensive Care 2002;30:633-40 25

4. Aronson WL, McAuliffe MS, Miller K. Variability in the American Society of 26 Anesthesiologists Physical Status Classification Scale. AANA J. 2003;71:265–74 27

5. Jacqueline R, Malvivya S et al. An assessment of interrater reliability of the ASA physical 28 status classification in pediatric surgical patients. Paediatr Anaesth 2006;16:928-31 29

6. Burgoyne LL, Smeltzer MP. How well do pediatric anesthesiologists agree when assigning 30 ASA physical status classifications to their patients. Paediatr Anaesth 2007;17:956-62 31

7. Bernard PA, Makin CE et al. Variability of ASA physical status class assignment among 32 pediatric sedation practitioners. Int J Adolesc Med Health 2009;21:213-20 33

8. Cuvillon P, Nouvellon E et al. American Society of Anesthesiologists' physical status system: 34 a multicentre Francophone study to analyse reasons for classification disagreement. Eur J 35 Anaesthesiol 2011;28:742-7 36

9. McMillan M, Brearley J. Assessment of the variation in American Society of 37 Anesthesiologists Physical Status Classification assignment in small animal anaesthesia. Vet 38 Anaesth Analg. 2013 May;40(3):229-36 39

10. Sankar A, Johnson SR et al. Reliability of the American Society of Anesthesiologists physical 40 status scale in clinical practice. Br J Anaesth 2014 Apr 11 (epub ahead of print) 41

http://www.sedasys.com/

https://phpmm.org/Portals/79/WebFiles/Provider%20Manual%20Updates/Clinical%20Guidelines/MQIC%202009%20Office-Based%20Surgery%20Guideline.pdf

https://phpmm.org/Portals/79/WebFiles/Provider%20Manual%20Updates/Clinical%20Guidelines/MQIC%202009%20Office-Based%20Surgery%20Guideline.pdf

http://www.choosingwisely.org/doctor-patient-lists/american-society-of-anesthesiologists/

http://www.choosingwisely.org/doctor-patient-lists/american-society-of-anesthesiologists/

item number: 8.3 governing body meeting · the potential full year impact for the ccg based on...

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