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Low Priority Procedures Process NW London Commissioning Consortium & North West London Hospital Trust Brent Teaching Primary Care Trust Working with our partners for a healthier Brent www.brentpct.nhs.uk

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Page 1: Low Priority Policy.doc.doc

Low Priority Procedures Process NW London Commissioning Consortium &

North West London Hospital Trust

Brent

Teaching Primary Care TrustWorking with our partners for a healthier

Brentwww.brentpct.nhs.uk

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Low Priority Procedures Process

North West London Hospital Trust

1. Introduction

Brent PCT, in conjunction with its consortium PCTs, has identified in the 2008/09 contract certain elective surgical interventions as “low priority” which should not be funded by the NHS. Low priority procedures can broadly be classified into four groups:

Procedures with limited evidence of effectiveness Procedures where initial conservative therapy is possible Effective procedures where a threshold for intervention may be appropriate Procedures where NHS provision may be inappropriate

2. Agreed Process

2.1 For treatments outside the contract where criteria apply

A group prior approval process will be applied PCTs will take responsibility for ensuring that GPs keep to the process in relation

to referrals NWLH will take responsibility for ensuring that acute clinicians keep to the process

in relation to decisions to treat NWLH will keep individual simple audit forms for all low priority cases signed by a

consultant. As a minimum these will record the source of referral (by GP practice) and tick list demonstrating how criteria have been met.

NWLH together with Brent PCT, as the lead commissioner, will undertake quarterly audits. This will comprise of a review of 100 randomly selected patient notes against the contracted HRGs OPCS codes for low priority procedures across all PCTs using the SUS data. The audit would ascertain whether a low priority treatment form had been completed, providing evidence that the patient met the criteria.

The % treatments identified through the audit as having been undertaken outside of the agreed criteria / process (as per the individual cases audit forms) within the sample will be applied to all treatments undertaken within this process within the same time period and the SLA payment for that quarter’s low priority procedures will be reduced accordingly on a quarterly basis.

This process will be undertaken by Brent PCT as lead commissioner on behalf of all participating PCTs and the same % will apply across all PCTs.

2.2 For exceptional circumstances where a patient falls outside agreed criteria

Should any clinician identify a case where the patient falls outside the agreed criteria but there are exceptional circumstances that should be considered in relation to referral / treatment this will be electronically referred to the relevant PCT using the established TOSLA form (Appendix 1 of Low Priority procedure).

Only electronically received copies will be accepted. Complete the form as fully as possible and include any additional information or evidence you feel will enable the decision to be made. Once completed the form should be sent by email to the patient’s PCT. For NW London PCTs the following e mail addresses should be used:

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Brent PCT - [email protected] Harrow PCT - [email protected] Ealing PCT - [email protected] Hillingdon PCT - [email protected] For all other PCTs the relevant e mail address will need to be obtained from that PCT.

Referral will be acknowledged by the PCT electronically within 4 working days. All responses will be made electronically

Each PCT’s decision making forum will consider all the evidence and make a recommendation on the information provided as well as that obtained from other sources. In some instances the requests may need to be referred to the PCT exceptional treatment panel. A decision on treatment will normally be made by the PCT within four weeks.

3. Changes to the List or Criteria The current low priority procedures list is identified below and reflects the list in the 2008/09 contract with NWLHT. The existing criteria will be applied and any changes to the criteria will be subject to negotiation. Additional procedures may be added to this list by referring it to Brent PCT and negotiating it within the consortium. As the co-ordinating commissioner, it is Brent PCT’s responsibility to ensure that NWLHT is informed of any changes.

The most urgent areas identified for review relate to minor surgery and other procedures where NWLH already operate more stringent criteria than set out (NWLH will continue to apply these in the interim).

4. Low Priority Procedures

4.1 Low Priority Procedures List Requiring Prior Approval

HRG OPCS Code OPCS Description     LOW PRIORITY REQUIRING PRIOR APPROVAL AS PER 08/09 CONTRACT J01 B301 Insertion of prosthesis for breastJ01 B302 Revision of prosthesis for breastJ01 B308 Prosthesis for breast OSJ01 B309 Prosthesis for breast unspecifiedJ01 B311 Reduction mammoplastyJ01 B312 Augmentation mammoplastyJ01 B313 MastopexyJ01 B314 Revision of mammoplastyJ01 B356 Eversion of nippleJ04 B302 Revision of prosthesis for breastJ04 B308 Prosthesis for breast OSJ04 B312 Augmentation mammoplastyJ04 B314 Revision of mammoplastyJ04 B356 Eversion of nippleJ05 B302 Revision of prosthesis for breastJ05 B308 Prosthesis for breast OSJ05 B312 Augmentation mammoplastyJ05 B314 Revision of mammoplasty

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J05 B356 Eversion of nippleJ06 B303 Removal of prosthesis for breastJ07 B303 Removal of prosthesis for breastJ07 S011 Facelift and tightening of platysmaJ07 S012 Facelift necJ07 S021 AbdominoplastyJ07 S022 AbdominolipectomyJ07 S031 Buttock liftJ07 S032 Thigh liftJ07 S211 Hair bearing flap skin to scalp for male pattern baldnessJ07 S212 Hair bearing flap of skin to scalp necJ07 S332 Hair bearing strip graft to scalp for male pattern baldnessJ07 S333 Hair bearing graft to scalp for male pattern baldness necJ29 S011 Facelift and tightening of platysmaJ29 S012 Facelift necJ29 S013 Submental lipectomyJ29 S014 BrowliftJ29 S018 Plastic excision of skin of head or neck OSJ29 S019 Plastic excision of skin of head or neck unspecifiedJ29 S031 Buttock liftJ29 S032 Thigh liftJ29 S332 Hair bearing strip graft to scalp for male pattern baldnessJ29 S333 Hair bearing graft to scalp for male pattern baldness necJ32 S011 Facelift and tightening of platysmaJ32 S012 Facelift necJ32 S013 Submental lipectomyJ32 S014 BrowliftJ32 S018 Plastic excision of skin of head or neck OSJ32 S019 Plastic excision of skin of head or neck unspecifiedJ32 S032 Thigh liftJ32 S332 Hair bearing strip graft to scalp for male pattern baldnessJ32 S333 Hair bearing graft to scalp for male pattern baldness necJ33 S331 Hair bearing punch graft to scalp for male pattern baldnessJ33 S601 Dermabrasion of skin of head or neckJ33 S602 Dermabrasion of skin necJ33 S621 Liposuction of subcutaneous tissue of head or neckJ33 S622 Liposuction of subcutaneous tissue necJ34 S603 Tattooing of skinJ34 S604 Refashioning of scar necJ35 S603 Tattooing of skinJ35 S604 Refashioning of scar necJ50 B301 Insertion of prosthesis for breastJ50 B302 Revision of prosthesis for breastJ50 B308 Prosthesis for breast OSJ50 B309 Prosthesis for breast unspecifiedJ50 B311 Reduction mammoplastyJ50 B312 Augmentation mammoplastyJ50 B313 MastopexyJ50 B314 Revision of mammoplastyJ50 B356 Eversion of nipple

4.2 Procedures where criteria apply

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PCTs will not fund these procedures unless they meet the criteria listed in the low priority policy (annex A). It is expected that activity related to these procedures will reduce in line with the level of activity of the best performing trusts nationally. It is the responsibility of referring and treating clinicians to ensure that only patients meeting the defined criteria are referred or treated. The majority of ineligible patients should not be referred and thus adherence to this policy is the responsibility of the referring clinician. PCTs will monitor adherence to this policy via monthly audit of the simple audit sheets in the patient’s notes.

LOW PRIORITY PROCEDURES WHERE CRITERIA APPLYB17 C132 Blepharoplasty of upper eyelidB17 C133 Blepharoplasty of lower eyelidB17 C134 Blepharoplasty necB18 C131 Blepharoplasty of both eyelidsB18 C181 Correction of ptosis eyelid using levator muscle techniqueB18 C182 Correction of ptosis eyelid using frontalis muscle techniqueB18 C183 Correction of ptosis of eyelid using sling of fasciaB18 C184 Correct ptosis eyelid using superior rectus muscle techniqueB18 C186 Correction of ptosis of eyelid using aponeurosis techniqueB18 C188 Correction of ptosis of eyelid OSB18 C189 Correction of ptosis of eyelid unspecifiedC21 D033 PinnaplastyC21 D038 Plastic operations on external ear OSC21 D039 Plastic operations on external ear unspecifiedC21 D062 Repair of lobe of external earC32 E025 Reduction rhinoplastyC32 E026 Rhinoplasty necC32 E028 Plastic operations on nose OSC32 E029 Plastic operations on nose unspecifiedC56 E094 Shave of skin of noseJ29 S021 AbdominoplastyJ29 S022 AbdominolipectomyJ29 S028 Plastic excision of skin of abdominal wall OSJ29 S029 Plastic excision of skin of abdominal wall unspecifiedJ32 S021 AbdominoplastyJ32 S022 AbdominolipectomyJ32 S028 Plastic excision of skin of abdominal wall OSJ32 S029 Plastic excision of skin of abdominal wall unspecifiedJ32 S031 Buttock liftL42 N181 REVERSAL OF BILATERAL VASECTOMYL43 N181 REVERSAL OF BILATERAL VASECTOMYM05 Q291 REANASTOMOSIS OF FALLOPIAN TUBEM05 Q292 OPEN REMOVAL OF CLIP FROM FALLOPM05 Q298 OTHER SPECIFIEDM05 Q299 UNSPECIFIED ( femal sterilisation)M06 Q291 REANASTOMOSIS OF FALLOPIAN TUBEM06 Q292 OPEN REMOVAL OF CLIP FROM FALLOPM06 Q298 OTHER SPECIFIEDM06 Q299 UNSPECIFIED ( femal sterilisation)M07 Q291 REANASTOMOSIS OF FALLOPIAN TUBEM07 Q292 OPEN REMOVAL OF CLIP FROM FALLOPM07 Q298 OTHER SPECIFIEDM07 Q299 UNSPECIFIED ( femal sterilisation)M08 Q291 REANASTOMOSIS OF FALLOPIAN TUBEM08 Q292 OPEN REMOVAL OF CLIP FROM FALLOP

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LOW PRIORITY PROCEDURES WHERE CRITERIA APPLYM08 Q298 OTHER SPECIFIEDM08 Q299 UNSPECIFIED ( femal sterilisation)C55 D151 Insertion of ventilation tube through tympanic membraneC55 D158 Drainage of middle ear OSC55 D159 Drainage of middle ear unspecifiedC55 D202 Maintenance of ventilation tube through tympanic membraneC55 D203 Removal of ventilation tube from tympanic membraneC55 D208 Other operations on middle ear OSC55 D209 Other operations on middle ear unspecifiedC55 D288 Other operations on ear OSC55 D289 Other operations on ear unspecifiedC57 F091 Surg rem impacted wisdom toothC57 F092 Surg rem impacted tooth NECC57 F093 Surg removal wisdom tooth NECC57 F094 Surgical removal of tooth NECC57 F095 Surg rem retained tooth rootC57 F098 Surgical removal of tooth OSC57 F099 Surgical removal of tooth NOSC58 E201 Total adenoidectomyC58 E208 Operations on adenoid OSC58 E209 Operations on adenoid unspecifiedC58 F091 Surg rem impacted wisdom toothC58 F092 Surg rem impacted tooth NECC58 F093 Surg removal wisdom tooth NECC58 F094 Surgical removal of tooth NECC58 F095 Surg rem retained tooth rootC58 F098 Surgical removal of tooth OSC58 F099 Surgical removal of tooth NOSC58 F341 Bilateral dissection tonsillectomyC58 F342 Bilateral guillotine tonsillectomyC58 F344 Bilateral excision of tonsil necC58 F345 Excision of remnant of tonsilC58 F346 Excision of lingual tonsilC58 F348 Excision of tonsil OSC58 F349 Excision of tonsil unspecifiedC58 F361 Destruction of tonsilC58 F368 Other operations on tonsil OSC58 F369 Other operations on tonsil unspecifiedC60 D241 Implantation of intracochlear prosthesis C60 D242 Implantation of extracochlear prosthesisH13 A651 Carpal tunnel releaseH13 A658 Release of entrapment of peripheral nerve at wrist OS H13 A659 Release of entrapment of peripheral nerve at wrist USL38 N301 PrepuceplastyL38 N302 Freeing of preputial adhesionsL38 N303 CircumcisionL38 N304 Dorsal slit of prepuceL38 N305 Stretching of prepuceL38 N306 Manual reduction paraphimosisL38 N308 Operation on prepuce OSL38 N309 Operation on prepuce NOSL39 N301 Prepuceplasty

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LOW PRIORITY PROCEDURES WHERE CRITERIA APPLYL39 N302 Freeing of preputial adhesionsL39 N303 CircumcisionL39 N304 Dorsal slit of prepuceL39 N305 Stretching of prepuceL39 N306 Manual reduction paraphimosisL39 N308 Operation on prepuce OSL39 N309 Operation on prepuce NOSM07 Q072 Abdominal hysterectomy and excision periuterine tissue nec M07 Q073 Abdominal hysterocolpectomy necM07 Q074 Total abdominal hysterectomy nec M07 Q075 Subtotal abdominal hysterectomy M07 Q078 Abdominal excision of uterus M07 Q079 Abdominal excision of uterus unspecified M07 Q081 Vaginal hysterocolpectomy and excision of periuterine tissueM07 Q082 Vaginal hysterectomy and excision of periuterine tissue necM07 Q083 Vaginal hysterocolpectomy nec M07 Q088 Vaginal excision of uterus OS M07 Q089 Vaginal excision of uterus unspecified Q11 L832 Subfascial ligation of perforating vein of legQ11 L851 Ligation of long saphenous veinQ11 L852 Ligation of short saphenous veinQ11 L853 Ligation of recurrent varicose vein of legQ11 L858 Ligation of varicose vein of leg OSQ11 L859 Ligation of varicose vein of leg unspecifiedQ11 L871 Stripping of long saphenous vein Q11 L872 Stripping of short saphenous vein Q11 L873 Stripping of varicose vein of leg necQ11 L874 Avulsion of varicose vein of legQ11 L875 Local excision of varicose vein of legQ11 L876 Incision of varicose vein of leg Q11 L878 Other operations on varicose vein of leg OSQ11 L879 Other operations on varicose vein of leg unspecifiedQ11 L918 Other vein related operations OSQ11 L919 Other vein related operations unspecifiedQ11 L931 Excision of vein necQ11 L932 Incision of vein necQ11 L933 Ligation of vein nec

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Annex A

Low Priority Procedures PolicyContents

Introduction...............................................................3

Aesthetic Surgery......................................................3

Circumcision..............................................................3

Cochlear Implants......................................................3

Surgery for Carpal Tunnel Syndrome.........................3

Dental Implants.........................................................3

Grommets..................................................................3

HOMEOPATHY............................................................3

Hysterectomy for Heavy Menstrual-Bleeding............3

Minor Skin Lesions.....................................................3

Reversal of Sterilisation.............................................3

Tonsillectomy............................................................3

Varicose Veins...........................................................3

Wisdom Teeth Removal.............................................3

Appendix 1.

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Low Priority Procedure Request Form ……………………………44

Introduction

Policy statement

PCTs are required to improve and care for the health of their populations within a limited financial envelope. It is therefore appropriate for PCTs to ensure that the most effective use is made of the resources they have. This implies a priority setting culture where the access to some treatments or procedures, of low effectiveness or cost effectiveness, is limited. This isan ethically and legally sound position for PCTs to take.

Brent PCT, as the co-ordinating commissioner, will establish and maintain a list of low priority procedures which will only be funded on an exceptional basis or where patients have been treated or investigated within defined referral or treatment criteria. The list follows this policy introduction. This list includes two categories of procedure:

1. Those which, as routine are not provided by the PCT and where provision is only possible on an individual patient basis, via the referral of the case by the relevant clinician to the PCT Treatment Outside of Service Level Agreement panel (TOSLA panel). These are listed as “PARTIALLY EXCLUDED PROCEDURE”

2. Those which may be offered on a routine basis but only for patients who meet defined criteria. These are listed as “THRESHOLD APPLIES”

Ethical framework

The principles on which this low priority procedure policy is built and implemented should be embedded within a transparent and reasonable ethical framework. These principles include:

Benefit vs. harm - If there is insufficient evidence that a treatment confers a benefit its use should be questioned• The default position should be that a treatment is not offered

unless a case can be made for its use in a particular circumstance• Evidence of effectiveness should be sought for all treatments from

a variety of sources including national guidance (such as NICE guidance) and repositories of clinical evidence (such as the Cochrane collaboration)

• For low priority treatments, guidelines on their use are needed and exceptional decisions should be taken on a patient by patient basis

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Equity/justice - the PCT should aim to provide equal access to treatments for all its patients, based on need• PCTs have a duty not to exceed their budgets and decisions

around limiting access to treatments should, legitimately, include aspects of financial cost. Decisions to treat inevitably divert resources from other health care options.

• Both cost effectiveness and individual cost of treatments should be considered in deciding which treatments to limit and in making individual patient decisions

• In some cases the needs of a community for a range of treatments may outweigh the needs of an individual for a highly expensive treatment of unproven effectiveness

Patient choice/autonomy – patients should have a right to request treatments and have their case heard and considered• The criteria and process for taking these decisions should be

transparent and deemed fair• A differently constituted body to that making initial decisions

should receive and hear appeals

Referral procedures

Partially excluded procedures Partially excluded procedures should not be referred for treatment or placed on treatment waiting lists without the approval of the Brent PCT TOSLA Panel. The TOSLA panel will assess the criteria on the basis of the information supplied on the TOSLA form. This panel meets monthly. Exceptionally, cases may be discussed between meetings.

Referrals to the TOSLA panel can only be made on an individual, named patient basis and must be made by an appropriate referring clinician. Decisions made by the panel will relate to the individual patient only and are not an indication of PCT policy or precedent for the provision this procedure. Neither are positive decisions an absolute approval for the treatment to go ahead, the clinical decision for which must rest with the clinician to whom the patient is referred in consultation with the patient themselves.

The following information must be provided:• Full patient details• Contact details for referring clinician• Full details of the costs of the procedure including all knock on

effects such as additional drug costs, monitoring costs• Full details of any cost savings to be gained from this procedure

such as likely downstream procedures avoided• Full details of patient’s clinical status and justification for the

effectiveness of the procedure for this case• Description of how the patient meets the eligibility criteria for the

individual procedure and the generic eligibility criteria of:

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treatment needs to be given immediately as a patient’s life is in jeopardy

or a delay in treatment will result in significant, immediate deterioration in a patient’s condition

• Where eligibility is felt to be due to the presence of a major psychiatric disorder details of this should be given including:

Psychiatric diagnosis Evidence that the psychiatric problem is clearly related to the

physical problem Details of the psychiatric and/or psychological interventions that

have been tried without success in the past

Wherever possible, an indication of whether further such cases are anticipated

Appeals process

In the case of a negative decision the patient and/or clinician will have the right to request the panel review its decision in the light of either:

additional evidence becoming available, that was not previously presented, which supports the case for exceptional need, or

there is reason to believe that the panel has not applied the policy fairly or correctly

All appeals should be made in writing to the PCT’s low priorities procedures co-ordinator. The appeals process will not affect the right of patients to pursue a complaint about funding through the statutory NHS complaints procedure.

Procedures where thresholds applyIt is the responsibility of referring and treating clinicians to ensure that only patients meeting the defined criteria are referred or treated. The majority of ineligible patients should not be referred and thus adherence to this policy is the responsibility of the referring clinician.

In the minority of cases it is recognised that a specialist opinion is needed before eligibility can be determined. In these cases it is the responsibility of the receiving clinician to ensure that threshold policies are adhered to and that referring clinicians are informed that they must receive the ineligible patient back into their care.

Audit and monitoring

PCTs will monitor adherence to this policy on a regular basis. This will be via:

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• Regular review of activity and financial payments made for partially excluded procedures to enable discussions at quarterly reconciliation meetings

• Planned audits of referrals in primary and secondary care

Addition of procedures to the policyAdditions will be made no more frequently than every six months. The Brent PCT Commissioning Steering Group will recommend additions to the policy based on evidence of effectiveness and local information on practice, activity and financial burden.

Policy review

Each low priority procedure has a review date. These are annual unless otherwise specified. Any amendments will be ratified by Brent PCT Board and communicated to stakeholders.

Availability of policies

All policies will be available on Brent PCT website and any amendments flagged.

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Aesthetic Surgery

Introduction

The aim of these guidelines is to provide effective criteria that allow requests for aesthetic surgery/interventions to be limited to patients in high-need groups. Also, to update previous local policies, in order to bring them more in-line with nationally-published guidelines.

The national guidelines referred to are in the document Action On Plastic Surgery ‘Information for Commissioners of Plastic Surgery Services. Referrals and Guidelines in Plastic Surgery’. A table, based on these national guidelines, forms the main body of this document.

The Action On guidelines were developed by a multi-professional sub-group of the NHS Modernisation Agency’s ‘Action On plastic surgery programme’. From the guidance:

The group reviewed the existing policies in place across the NHS and considered any available evidence of effectiveness and outcome for individual procedures. Where no robust evidence was available the guidance represents a consensus view.

This national set of guidelines can be used as a justification for contract exclusions/other policies in aesthetic surgery in Brent. However, some of the decisions about procedures might have been taken by ‘consensus view’ rather than on an evidence-base. Previous Brent guidelines have sought to prevent the commissioning of procedures in the following circumstances:

where procedures have not been shown to be effective;

where procedures are for purely aesthetic/cosmetic procedures;

where procedures are required as follow-up to operations done in the private sector;

where another intervention is available;

where there is a sense in which the procedure is necessary, or in which results of surgery may be impaired, as a consequence of the patient’s own actions ( tattooing, piercing, obesity, smoking and others).

The line between these two groups is blurred, for a number of reasons: almost all surgery has an aesthetic element to it; appearance is an important surgical outcome. It occurs, therefore, that much surgery that is not aesthetic will have cosmetic components.

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In view of these considerations, some modifications have been made to the national guidelines (these are highlighted by a ** in the table below). These changes are principally in areas where the national guidelines may be insufficiently robust or would represent a service development in a low priority area, and are intended to give PCTs greater control over exclusions. Examples from the draft guidelines are as follows.

The guidelines in Action On concerning breast-enlargement surgery have been amended so that this surgery can only be approved by the exceptional route.

Likewise, breast-lift surgery changed classification in this guideline, so that it is only provided in exceptional circumstances.

For face lifts and brow lifts, when trauma is the indication for surgery, the appropriateness of funding surgery should be considered via the exceptions route.

In nasal surgery, problems caused by obstruction of the nasal airway must be considered by the exceptions route.

Surgery to correct prominent ears in patients under five year old will only be considered by the exceptions route.

For abdominoplasties, the exceptions panel will assess whether or not the patient meets the criteria below (because of the complexity of these criteria).

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1) Procedure 2) Patient group that may be considered for funding of surgery

3) Actions that need to be undertaken before consideration of surgery

4) Contra-indications to surgery in patients who fall into patient group in column 2).

Female breast reduction

This procedure will not normally be funded. Exceptional circumstances only.**

1) Symptoms not relieved by wearing a fitted brassiere (fitted by trained bra fitter).

Body mass index greater than or equal to 30.

Breast enlargement (Augmentation mammoplasty)

This procedure will not normally be funded. Exceptional circumstances only.**

If surgery is to be performed, patients undergoing breastaugmentation should:

1) be encouraged to participate in the UK national breast implant registrationsystem;

2) be counselled regarding the risks and natural history of breast implants;

3) be provided with a copy of the DoH guidance booklet “Breast implants information for women considering breast implants”;

4) understand that they may not be entitled to replacement of the implant(s) in future (except in cases of leaking implants with health consequences), if criteria for augmentation are not met at that time.

‘Tummy tuck’ (apronectomy or abdominoplasty)

Will not normally be funded**The exceptions panel will consider whether or not the patient fulfills the criteria outlined below.

Patient groups:

• scarring following trauma or previous abdominal surgery;

• patients undergoing

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1) Procedure 2) Patient group that may be considered for funding of surgery

3) Actions that need to be undertaken before consideration of surgery

4) Contra-indications to surgery in patients who fall into patient group in column 2).

treatment for morbid obesity who haveexcessive skin folds;

• previously obese patients, who have lost a large amount of weight and maintained the loss for at least two years;

• as part of abdominal hernia correction or otherabdominal wall surgery.

Criteria:

1) Need to have achieved a stable BMI between 18 and 27 kg/m2.

AND

2) Have severe functional problems which may include:

• recurrent intertrigo beneath the skin fold;

• severe difficulties with daily living i.e. ambulatory restrictions;

• post-trauma or surgical scarring leading to poor appearance and resulting in disablingpsychological distress or risk of infection;

• poorly-fitting stoma bags.Breast lift (Mastopexy)

This procedure will not normally be funded. Exceptional circumstances only. **

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1) Procedure 2) Patient group that may be considered for funding of surgery

3) Actions that need to be undertaken before consideration of surgery

4) Contra-indications to surgery in patients who fall into patient group in column 2).

Male Breast Reduction for Gynaecomastia(Liposuction may form part of the treatment plan for this condition)

Post pubertal patients with severe** gynaecomastia. Pre-authorisation is required from the PCT. Approval will only be given for post-pubertal males, who are of normal height weight ratio, when the proposed volume of reduction is greater than 200g per side or for gross asymmetry’**

1) Male breast cancer should not be mistaken for gynaecomastia. If there is any doubt, urgent specialist consultation should be obtained.

2) Screen for endocrinological and drug related causes and/or psychological distress.

BMI > 25 kg/m2

.

Revision of Breast Augmentation

Revision surgery will only considered if the NHS commissioned the original surgery (e.g. post malignancy)**

If surgery is for implant failure, the decision to fund surgery should be based on clear evidence of adverse health consequences related to failure. The NHS will not fund the cost of replacement of the implant without prior approval**

Original implant not carried out on NHS.

Nipple Inversion This procedure will not normally be funded. Exceptional circumstances only**

1) Nipple inversion may occur as a result of breast malignancy; it is essential that this be excluded.

2) Use of a non-invasive suction device.

Face lifts and brow lifts (Rhytidectomy)

These procedures will be considered for the treatment of:

• congenital facial abnormalities;

• facial palsy;

• treatment of rare specific conditions affecting the facial skin, e.g. cutis laxa, pseudoxanthoma elasticum, neurofibromatosis;

Not to treat the natural processes of ageing.

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1) Procedure 2) Patient group that may be considered for funding of surgery

3) Actions that need to be undertaken before consideration of surgery

4) Contra-indications to surgery in patients who fall into patient group in column 2).

• deformity following surgery.

• when trauma is the indication for surgery, this must be considered via the TOSLA panel.**

Surgery on the upper eyelid (Upper lid blepharoplasty)

To correct functional impairment including:

1) impairment of visual fields in the relaxed, non-compensated state;

2) clinical observation of poor eyelid function;

3) discomfort (such as headache worsening towards end of day) and/or evidence of chronic compensation through elevation of the brow.

Not purely for cosmetic reasons.

Surgery on the lower eyelid (Lower lid blepharoplasty)

Available for:

1) correction of ectropion or entropion

2) Removal of lesions of the eyelid skin or lid margin.

Excessive skin in the lower lid may cause ‘eyebags’, but, does not affect eyelid function or vision and, therefore, does not need correction.

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1) Procedure 2) Patient group that may be considered for funding of surgery

3) Actions that need to be undertaken before consideration of surgery

4) Contra-indications to surgery in patients who fall into patient group in column 2).

Surgery to reshape the nose (Rhinoplasty)

Problems caused by obstruction of the nasal airway must be considered by the exceptions route.**

Available for:

1) objective nasal deformity caused by trauma;

2) correction of complex congenital conditions e.g. cleft lip and palate. (This should be pre-authorised by the PCT following completion of a form).

Prior ENT consultation may be considered for patients with isolated airway problems (in the absence of visible nasal deformity).

Correction of prominent ears (Pinnaplasty / Otoplasty)

This procedure will not normally be funded. Exceptional circumstances only.**

• Patient should be seen by a plastic surgeon, and, following assessment, if there is any concern, assessed by a psychologist.

• Patients under 5 years of age at the time of referral will only be considered for surgery by the exceptions route.

Repair of external ear lobes (lobules)

Repair of completely split ear lobes as a result of direct trauma.

Advice regarding:

• likely success rate;

• the risk of keloid and hypertrophic scarring at this site;

• the risks of further trauma with re-piercing of the ear lobule.

Operations on congenital anomalies of the face and skull

Usually available. Some such conditions are highly specialised and are commissioned in the UK through NSCAG.

Correction of post traumatic bony and soft tissue deformity

Is available on the NHS.

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1) Procedure 2) Patient group that may be considered for funding of surgery

3) Actions that need to be undertaken before consideration of surgery

4) Contra-indications to surgery in patients who fall into patient group in column 2).

of theface

Correction of hair loss (Alopecia)

Available on NHS only when the result of previous surgery or trauma, including burns.

Correction of male pattern baldness

Is excluded from treatment by the NHS.

Hair transplantation

This procedure will not normally be funded. Exceptional circumstances only.**

Other skin excision for contour e.g. Buttock lift, Thigh lift, Arm lift (brachioplasty)

This procedure will not normally be funded. Exceptional circumstances only.**

Liposuction This procedure will not normally be funded. Exceptional circumstances only.**

.

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1) Procedure 2) Patient group that may be considered for funding of surgery

3) Actions that need to be undertaken before consideration of surgery

4) Contra-indications to surgery in patients who fall into patient group in column 2).

Minor skin lesions (benign pigmented moles,comedones,corn/callous,lipoma,milia,molluscum contagiosum,sebaceous cysts (epidermoid or pilar cysts),seborrhoeic keratoses (basal cell papillomata),skin tags including anal tags,spider naevus (telangiectasia),warts,xanthelasma,neurofibromata)

Minor skin lesions are covered in a separate section of this document.

Tattoo removal This procedure will not normally be funded. Exceptional circumstances only.**

Skin hypo-pigmentation

This procedure will not normally be funded. Exceptional circumstances only.**

Cosmetic camouflage is recommended treatment. This should be byaccess to a qualified camouflage beautician.

Vascular skin lesions

This includes treatment of port wine stains on head and neck. **

Treatment of small, benign, acquired, vascular lesions such as thread veins and spider naevi.

This procedure will not be funded.

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1) Procedure 2) Patient group that may be considered for funding of surgery

3) Actions that need to be undertaken before consideration of surgery

4) Contra-indications to surgery in patients who fall into patient group in column 2).

Acne vulgaris(resurfacingand other surgical interventions for scarring)

This procedure will not normally be funded. Exceptional circumstances only.**

The treatment of active acne vulgaris should be provided in primary care orby a dermatology service.

Rhinophyma PCTs should not fund any surgical or laser treatment for rhinophyma except in exceptional circumstances

Skin resurfacing techniques(including laser, dermabrasion and chemical peels)

This procedure will not normally be funded. Exceptional circumstances only.**

Botulinum toxin Treatment of pathological conditions by appropriate specialists, for example in: • Blepharospasm;• Cerebral palsy.

Not available for the treatment of facial ageing or excessive wrinkles.

Hair depilation (hair removal)

This procedure will not normally be funded. Exceptional circumstances only.**

Gender reassignment surgery

Patients should be referred to recognized NHS programme of care for management of these cases. Each case should be considered on itsindividual merits.

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Circumcision

Circumcision is a surgical procedure that involves partial or complete removal of the foreskin (prepuce) of the penis.

Circumcision is considered a low priority treatment. It should only be funded by the NHS for medical reasons, and not for religious or social reasons.

Medical indications for circumcision are (subject to specialist surgical assessment and advice): phimosis in children with spraying, ballooning and/ or recurrent infection; adult phimosis; recurrent balanitis; balantitis xertotica obliterans; paraphimosis; 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).

Evidence

There is much debate currently in the medical literature about circumcision. There are claims that there may be health benefits associated with this procedure, for example, a lower rate of penile cancer and a reduced chance of sexual transmitted diseases including HIV. However, the evidence is inconclusive.

Haemorrhage and infection are well-recognised complications. In addition, in the long-term, problems such as psychological trauma and possible decreased sexual pleasure have been reported.

Glossary:

Phimosis - a tight ring often made of scar tissue preventing retraction of the foreskin, which may be primary, or secondary to recurrent infection Balanitis - infection of the glans/ glans and foreskin Balantitis xertotica obliterans - lichen sclerosis primarily affecting the foreskin Paraphimosis – Inability to replace the foreskin after retraction

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/312/7026/2992. 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/311/7018/14713. General Medical Council. Guidance for doctors who asked to circumcise male children. (September 1997). www.gmc uk.org/n_hance/good/circum.htm4. Norm-UK. Clinical Guidelines: the management of phimosis October 1999.http://www.norm-uk.co.uk/clinicalguide.htm

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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/320/7249/15926. Black’s Medical Dictionary. 40th Edition. A & C Black. London. 2002.

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Cochlear Implants

The PCT will fund cochlear implantation in those people meeting the following criteria:

In Children

Bilateral severe-to-profound sensorineural hearing loss (i.e. ≥ 90dBHL at 2000Hz and above for better ear) also ski slope or reverse losses

Average PTA ≥ 90dBHL (progressive hearing loss to be referred before reaching this level)

Limited or no useful benefit from hearing aids: Birth-2 years: limited access to speech sounds with hearing aids 2-5 years: failure to develop acceptable level of auditory skills (e.g. speech

and language delay) > 5 years: 50% or less open-set sentence discrimination

In Adults

50% or less open-set sentence discrimination scores in ear to be implanted Bilateral severe-to-profound sensorineural hearing loss (i.e. ≥ 90dBHL at 2000Hz

and above for better ear) including ski slope or reverse losses Average PTA ≥ 90dBHL (progressive hearing loss to be referred before reaching this

level) Post lingual hearing loss with oral/aural communication skills Limited or no useful benefit from hearing aids

Definition

A cochlear implant is a sophisticated hearing aid which stimulates the cochlear nerve directly. A cochlear implant improves the ability to hear environmental sounds such as cars, doorbells, and pets, and to hear rhythms and patterns of speech, thus improving speech recognition. The technology is continually improving and now in some cases hearing improves enough to allow telephone conversation. The implantation itself is a relatively simple surgical procedure, but the overall process involves a complex series of pre-operative investigations and post-operative training and follow-up.

Rationale

Cochlear implantation is appropriate for only a minority of those with sensorineural hearing impairment.

The potential health gain for children is dramatic and includes improvement in speech and language skills, hence their education

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The universal neonatal hearing screening programme is identifying children who are congenitally deaf at a very young age.

Although it is a relatively simple procedure there is a chance of complications associated with any surgical intervention.

Evidence

Deaf children who have cochlear implants by the time they are two-and-a-half years old have the best chance of developing auditory abilities close to those of children with normal hearing.

Cochlear implants dramatically increase the speech and language development of hearing impaired children, making integration into mainstream school easier and significantly reducing the costs of education.

Cochlear implants are becoming a more effective intervention for adults and children with a severe to profound sensorineural hearing loss who are no longer able to benefit or who have never benefited from hearing aids

References

Schorr, E.A., N.A. Fox, et al. In press. Auditory-visual fusion in speech perception in children with cochlear implant. Proceedings of the National Academy of Sciences. Abstract available at http://www.pnas.org/cgi/doi/10.1073/pnas.0508862102.

Sharma, A., M.F. Dorman, and A.J. Spahr. 2002. A sensitive period for the development of the central auditory system in children with cochlear implants: Implications for age of implantation. Ear & Hearing 23(December):532-539. Abstract

Francis HW, Niparko JK. Cochlear implantation update; Pediatr Clin N Am 2003; 50: 341-361

Cohen NL. Cochlear Implant Candidacy and Surgical Considerations; Audiol Neurootol. 2004; 9(4):197-202.

West Sussex PCTs PCTs Cochlear Implant Policy

Cambridgeshire and Peterborough Public Health Network Cochler Implants Policy

British Cochlear Implant Group http://www.bcig.org

The National Deaf Children’s Society http://www.ndcs.org.uk/about_ndcs/ndcs_policies_campaigns/ndcs_policies/cochlear_implant.html

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Surgery for Carpal Tunnel SyndromeThe PCT will fund carpal tunnel surgery where: Symptoms persist after conservative therapy with either local

corticosteroid injection and/or nocturnal splinting.

OR

There is neurological deficit, eg sensory blunting, muscle wasting or weakness of thenar abduction.

OR

Severe symptoms significantly interfere with daily activities.

Rationale

Conservative treatment offers short-term benefit (1-3 months) similar to surgery and many patient’s 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 injection and nocturnal splinting are effective conservative therapies.

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.

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

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

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)

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

Non surgical treatment, including oral steroid, splinting, ultrasound, yoga and carpal bone mobilisation show short-term benefit. (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 RCTs compared surgery to injected steroids. One (n=50) showed greater symptomatic improvement with surgery at 20 week. The other (n=163) showed greater improvement in the steroid group for nocturnal paraesthesia at 3 months but equivalence at six and twelve months. In the second study most patients needed two steroid injections and referal to surgery were counted as treatment failures in the intention to treat analysis. (Hui et al, 2005, Ly-Pen et al 2005)

One recent RCT of compared splinting to surgery. This study, included in the Cochrane review, showed improved outcomes with surgery at 3 month and 18 months. (Gerritsen et, 2002). By 18 months, 41% of the splinting group had undergone surgery.

Two RCTs have compared steroid injections and 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 et al, 2004). The other study (Celiker et al) compared NSAIDs and splinting to steroid injection. Both groups showed similar improvement at eight weeks.

References

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, randomized, open, controlled clinical trial. Arthritis Rheum 2005;52: 612-9

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.

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 randomized controlled trial of surgery vs steroid injection for carpal tunnel syndrome Neurology, June 28, 2005; 64(12): 2074 - 2078.

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

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.

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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

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.

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 randomized controlled trial. JAMA. 2002 Sep 11;288(10):1245-51.

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

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Dental Implants

Dental implants are considered a low priority procedure and will only be funded for patients with maxillofacial defects resulting from developmental or congenital disorders, major trauma or the treatment of tumours.

In exceptional circumstances the use of implants will be considered foredentulous or partially dentate patients meeting the criteria established by the Faculty of Dental Surgery guidance, and where tooth or tissue borne dentures (made using appropriate specialist techniques) have proved unsuccessful. Restorative dental treatment would be provided by tertiary referral.

Definition

An endosseous dental implant is a surgically implanted device which replaces the lost roots of a tooth. An artificial tooth, partial denture, or denture can be attached to the implant. Traditional procedures for replacing missing teeth include partial dentures, complete removable dentures, or fixed bridges that attach to existing teeth or rest on the gums. However, for individuals where this is not successful, eg those who have a weakened jawbone, who cannot manage removable dentures or cannot properly chew food, implants may be a preferred option.

Rationale

The Faculty of Dental Surgery has produced guidance on the selection of patients for dental implant treatment within the NHS. These include three groups of patients for consideration:

1. Edentulous in one or both jaws:• Severe denture intolerance (eg gagging, pain);• prevention of severe alveolar bone loss.2. Partially dentate:• preservation of remaining healthy teeth;• complete unilateral loss of teeth in one jaw.3. Maxillofacial and cranial defects:• intraoral prostheses, eg considerable amounts of missing hard

and soft tissue;• extraoral/cranial prostheses, eg partial or total loss of ears, eyes

or nose.

In each category a list of treatment options and a checklist to be considered before proceeding to dental implant treatment is provided.

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It is recommended that treatment outcomes for those receiving implants be audited.

Evidence

Dental implants have been shown to be a successful treatment for replacingmissing teeth by providing support for fixed bridge prostheses, individual crowns, and overdentures. Evidence from randomised controlled trials shows increased ability to chew tough food, and increased patient satisfaction with implants in comparison to normal dentures.

Complications of implant surgery include swelling, pain, bleeding, possibleinfection, and partial numbness at implant site. Nerve disturbances that may be permanent and bone fracture can occur, as can rejection of the implant. However, severe complications are rare.

References

1.Guidelines for selecting appropriate patients to receive treatment with dental implants: Priorities for the NHS. Faculty of Dental Surgery, National Clinical Guidelines 1997, Royal College of Surgeons.2. Lekholm U. The Surgical Site. In Lindhe J, Karring K and Lang NP (eds). Clinical Periodontology and Implant Dentistry. 3rd ed, p 890-905. Copenhagen: Munksgaard, 1998.3. Meraw SJ et al. Analysis of surgical referral patterns for endosseous dental implants. The International Journal of Oral and Maxillofacial Implants 14(2), 265-270, 1999.4. Balshi TJ et al. Analysis of 356 pterygomaxillary implants in edentulous arches for fixed prosthesis anchorage. International Journal of Oral and Maxilofacial Implants 14 (3), 398-406, 1999.5. Black’s Medical Dictionary. 40th Edition. A & C Black. London. 2002.6. Royal College of Surgeons 1997 Guidelines for Selecting Appropriate Patients To Receive Treatment With Dental Implants: Priorities For The NHS http://www.rcseng.ac.uk/dental/fds/pdf/ncg97.pdf.7. Awad M A, Locker D, Korner-Bitensky N, Feine J S. Measuring the effect of intra-oral implant rehabilitation on health related quality of life in a randomised controlled clinical trial. J Dent Res 2000; 79(9): 1659-63.8. Jonsson B, Karlsson G. Cost-benefit evaluation of dental implants. Int J Technol Assess Health Care 1990; 6(4): 545-57.9. Goodacre CJ, Kan JY, Rungcharassaeng K. Clinical Complications of Osseointegrated Implants. The Journal of Prosthetic Dentistry 1999; 81(5): 537-52.10. The Consort Group, The Consort Statement: revised recommendations for improving the quality of reports of parallel group randomised trials 2001 http://www.consort-statement.org/11. Lindh T, Gunne J, Tillberg A, Molin M. A meta-analysis of implants in partial edentulism. Clinical Oral Implants Research 1998; 9: 80-90.12. Bory E, Durieux P. Oral implantology. Current state of knowledge. Paris: Agence Nationale pour le Developement de l’Evaluation Medicale. L’Agence Nationale d’Accreditation d’Evaluation en Sante (ANAES). 1993; 87.13. Creugars N H, Kreulin C M, Snoek P A, de Kanter R J. A systematic review of single-tooth restorations supported by implants. J Dent Res 2000; 28(4): 209-17.14. Scottish Needs Assessment Report. Dental Implants. 2004.http://www.phis.org.uk/pdf.pl?file=publications/dental%20implants.pdf

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Grommets

The PCT will agree to fund treatment with grommets for children with otitis media with effusion (OME) where:

There has been a period of at least six months watchful waiting from the date of the first outpatient appointment/appointment with audiologist or /ENT GPSI AND the child is placed on a waiting list for the procedure at the end of this period

AND

OME persists after six months and the child (over three years of age) suffers from at least one of the following:

At least 5 recurrences of acute otitis media in a year

Delay in speech development

Educational problems or behavioural problems attributed to hearing impairment which is persistent. With a hearing loss of at least  25dB particularly in the lower tones (low frequency loss)

A second disability such as Down’s syndrome

Severe collapse of the ear drum

Rationale

Evidence of effectiveness is limited: surgery may resolve glue ear and improve hearing in the short term, but there is less certainty about long-term outcomes and large variation in effect between children.

There continues to be debate about how best to select children for surgery. The issue is complicated by the high rate of resolution of glue ear, particularly in younger children.

Timing of surgery may not be critical. A 1999 trial compared 9 months 'watchful waiting' with immediate surgery and found outcomes to be similar by 18 months (by this time, however, 85% of children in the watchful waiting group had been treated with grommets).

The benefits of surgery have to be balanced against possible harms. About one third of children who have grommets have complications. Tympanosclerosis frequently occurs after grommet insertion, infection may occur, and there is a slightly increased incidence of chronic perforation.

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The reduced risk of serious complications of anaesthesia and surgery must be balanced against the increased hearing loss and episodes of infection requiring antibiotic treatment and time off work, school or college.

Restricting access to grommets is not a new phenomenon: a 1995 survey revealed that 23 of the 129 then health authorities in England, Scotland and Wales had excluded grommets.

Evidence

Cochrane review: Grommets for hearing loss associated with otitis media with effusionLous J, Burton MJ, Felding JU, Ovesen T, Rovers MM, Williamson I

Conclusion: The benefits of grommets in children appear small. The effect of grommets on hearing diminished during the first year. Potentially adverse effects on the tympanic membrane are common after grommet insertion. Therefore an initial period of watchful waiting seems to be an appropriate management strategy for most children with OME. As no evidence is yet available for the subgroups of children with speech or language delays, behavioural and learning problems or children with defined clinical syndromes (generally excluded from the primary studies included in this review), the clinician will need to make decisions regarding treatment for such children based on other evidence and indications of disability related to hearing impairment.

BMJ Clinical Evidence: Otitis media with effusionWilliamson I

Summary:One systematic review found that grommets improved hearing at up to 2 years, but not at 5 years compared with no grommets. The clinical significance of the improvement seen (<10dB) was unclear. The review found that grommets did not significantly improve cognition, language comprehension or expression compared with no grommets, although relatively insensitive outcomes may have been used. Grommets were associated with an increased risk of tympanosclerosis at 1 year. One systematic review found that grommets plus adenoidectomy improved hearing at 6 months compared with no treatment, although the difference between the groups was reduced at 12 months. The review found no significant difference between the combined treatment and grommets alone at up to 12 months. Another review found that the combined treatment improved hearing more than adenoidectomy alone at up to 12 months, but found no significant difference between treatments at 2-5 years. The clinical significance of the improvements seen with surgery was unclear.

SIGN guideline recommendation:

A: Children under three years of age with persistent bilateral otitis media with effusion and hearing loss of =<25 dB, but no speech and language, development or behavioural problems, can be safely managed with watchful

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waiting. If watchful waiting is being considered, the child should undergo audiometry to exclude a more serious degree of hearing loss.

B: Children with persistent bilateral otitis media with effusion who are over three years of age or who have speech and language, developmental or behavioural problems should be referred to an otolaryngologist.

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HOMEOPATHY

These procedures will not normally be commissioned unless there are exceptional circumstances.

Rationale

Brent Primary Care Trust has considered the question of funding for homeopathy and reviewed best available evidence for clinical effectiveness of homeopathy treatments. This included high quality review papers from peer review journals.

Homeopathy has not been proved to be efficacious beyond the placebo for any one particular treatment by independently randomised control trials. Until this evidence is available, Brent Commissioning Group recommends the following:

That homeopathy should remain a low priority treatment due to the limited evidence for clinical effectiveness

The contract between Brent Primary Care Trust and the Royal London Homeopathic Trust has been terminated

Evidence

A number of meta-analyses have been published. The majority conclude that there is insufficient evidence for specific homeopathic remedies for specific clinical conditions (2-7). When compared with studies into conventional treatments, homeopathy studies show weak specific effects in contrast to the strong effects of allopathic interventions (8). These findings are compatible with the conclusion that the clinical effects of homoepathy are partly attributable to placebo. Although there is some evidence that homeopathic treatments are more effective than placebo, this evidence is weak as it comes from poor quality studies (9). Until more rigorous randomised trials on particular preparations for specific conditions are available, it is not possible to recommend the use of homeopathy.

References

1. Effective Health Care : Homeopathy 2002 7(3)http://www.york.ac.uk/inst/crd/ehc73.pdf

2. Bandolier (1997) Homeopathy-dilute information and little knowledge. Bandolier 1997, pp.42-5

3. Ernst E, Pitler MH (1998) Efficacy of homeopathic arnica: A systematic review of placebo and controlled clinical trials. Archives of Surgery 133:11: 1187-90

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4. Kleijnen J, Knipschild P, Reit G. (1991) Clinical trials of homeopathy. BMJ 1991 302: 316-147.

5. Linde K, Jobst K (1999) Homeopathy for chronic asthma. Cochrane Review 1999.

6. Reilley D (1994) Is the evidence for homeopathy reproducible? Lancet: 334:1601-6

7. Vickers A (1999) Homeopathic Oscilloccinum for preventing and treating influenza and influenza like syndromes. Cochrane review 1999.

8. Shang A, et al. (2005) Are the clinical effects of homeopathy placebo effects? Comparative study of placebo-controlled trials of homeopathy and allopathy. The Lancet; 366 726-732

9. Cucherat M, et al (2000) Evidence of clinical efficacy of homeopathy. European journal of clinical pharmacology. 56(1) April 27-33.

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Hysterectomy for Heavy Menstrual-Bleeding

PCTs will fund hysterectomy for heavy menstrual-bleeding only when:

There has been a prior trial with a LNG-IUS intra-uterine device (unless contraindicated) which this has not successfully relieved symptoms

AND

Other treatments (such as NSAIDs, Tranexamic Acid, Endometrial ablation, uterine-artery embolisation) have failed, are not appropriate or are contra-indicated in line with NICE guidelines.

Contraindications to LNG-IUS are:

Severe anaemia, unresponsive to transfusion or other treatment whilst a LNG-IUS trial is in progress

Distorted or small uterine cavity (with proven ultrasound measurements)

Genital malignancy

Active trophoblastic disease

Pelvic inflammatory disease

Established or marked immunosuppression

Rationale

The Mirena® device has been shown to be effective in the treatment of heavy menstrual-bleeding.

It is considerably cheaper than performing a hysterectomy, even if required for many years.

A number of effective conservative treatments are available as second line treatment after failure of Mirena or where Mirena is contra-indicated

Evidence

NICE released draft guidelines on heavy menstrual-bleeding (HMB) in July 2006, and these form the basis of these proposals. The

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proposals will be reviewed, when final guidelines are released by NICE (this is expected to be in January 2007).

A Cochrane systemic review concluded that LNG-IUS/Mirena® coil improved the quality of life of women with menorrhagia as effectively as hysterectomy.

In a NICE study of long-acting reversible contraception, the costs of Mirena® were assessed. The total first-year cost to the NHS was £207, including consultation fees. The removal cost was £26. Average duration of use was 3.32 years, giving an average annual cost to the NHS of £70. Costing for treatment of heavy menstrual bleeding is unlikely to differ greatly from these figures.

The cost to the PCT of performing a hysterectomy is £2362.

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Minor Skin Lesions

PCTs will fund removal of benign minor dermatological lesions where there is a suspicion of malignancy OR obstruction of orifice or vision OR functional limitation on movement or activity.

PCTs will consider funding of the removal of moderate to large facial lesions which cause disfigurement through prior approval.

Removal of lesions for other clinical indications including itching, bleeding, pain, active inflammation or recurrent trauma will be funded by the PCT subject to prior approval on an individual basis.

Lesions included in this policy include Benign Pigmented Moles Comedones: Corn/Callous: Lipoma: Milia Molluscum Contagiosum: Sebaceous cysts (epidermoid or pilar cysts) Seborrhoeic Keratoses (Basal Cell Papillomata): Skin Tags including anal tags Spider Naevus (Telangiectasia): Warts - patients will be considered only when all other

conventional forms of wart removal have been tried Xanthelasma Neurofibromata

Rationale

Approach supported by national guidelines on cosmetic surgery. Limited evidence that surgery on these lesions for aesthetic

reasons offers benefit to patients. Where there is no suspicion of malignancy or complications,

benign skin lesions may be self-limiting, respond to conservative measures and have no long-term, health consequences for patients.

The policy acknowledges the potential for uncertainty of diagnosis, and, where there is concern over risk of malignancy, a secondary-care opinion may be sought.

There is a wide clinical-consensus on the list of lesions included, and similar policies have been adopted by a number of PCTs.

References

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Action on referral and guidelines in plastic surgery. NHS Modernisation Agency

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Reversal of Sterilisation

Reversal of sterilisation 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.

It is recommended that thorough counselling be given to the patient and that the patient (and partner) have clear understanding before proceeding with sterilisation or vasectomy, ensuring that the patient is fully aware of current local NHS policy of not normally funding reversal of sterilisation and vasectomy.

It is recommended that sterilisation or vasectomy are not normally performed on those under 30, those who appear to be unstable or in conflict relationships and that sterilisation is not performed during caesarean section. Exceptions to these can be assessed during counselling.

Sterilisation is a procedure by which a person is rendered permanently unable to produce children. This is called 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.

Evidence

Health benefits: The need for reversal of sterilisation is not a life threatening condition, but the procedure may improve quality of life. Counselling before sterilization can reduce demand for reversal of sterilisation requests.Risks: Psychological and social distress.

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 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.uk2. Grew R. Reversal of sterilisation. North Essex Health Authority low priorities policy, 18 February 1999.

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3. Dorland’s Illustrated Medical Dictionary, 27th ed, W B Saunders 1988.4. Black’s Medical Dictionary. 40th Edition. A & C Black. London. 2002.

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Tonsillectomy

PCTs will not ordinarily fund tonsillectomy except in cases of suspected malignancy or significant severe impact on quality of life indicated by at least 7 episodes in the preceding year or 5 episodes/year in the preceding 2 years, or 3 episodes/year in the preceding 3 years and documented evidence of absence from school or attendance at GP or other health care setting.

Rationale

Tonsillectomy offers relatively small clinical-benefits, measured best in terms of time taken away from school. The benefit in the year after the operation is roughly 2.8 days less taken away from school.

Tonsillectomy carries a risk of mortality estimated to lie between 1 in 8,000 and 1 in 35,000 cases

The cost to the PCT of performing a day case tonsillectomy is £730.

Evidence

A Cochrane systemic review concluded that

“There is no evidence from randomised controlled trials to guide the clinician in formulating the indications for surgery in adults or children”

The frequency of sore throat episodes and upper respiratory infections reduces with time whether (adeno)tonsillectomy has been performed or not

(Adeno)tonsillectomy probably gives an additional, but small, reduction of sore throat episodes, days of sore throat associated school absence, and upper respiratory infections compared to watchful waiting

Tonsillectomy is not a recommended treatment for obstructive sleep Apneoa, according to SIGN guidelines

Sources:

Cochrane Database of Systematic Reviewshttp://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001802/frame.html

Adenotonsillectomy for upper respiratory infections:evidence based? Arch Dis Child 2005;90:19–25

Sign Clinical Guidelines for Obstructive Sleep Apnoeahttp://www.sign.ac.uk/pdf/sign73.pdf

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Varicose Veins

The PCT will fund surgery on lower-limb varicose-veins due to venous reflux where there are:

Skin changes or ulceration or bleeding or recurrent phlebitis (more than one documented episode)

OR

Severe symptoms attributable to the venous disease which not acceptably relieved by conservative management including compression hosiery

The PCT will not fund surgery for uncomplicated varicose vein where there are no significant physical symptoms or surgery for reticular veins or telangiectasia.

All referrals should be through an agreed pathway to optimise access to conservative treatment and advice.

Rationale

Varicose veins are common in the adult population, and the majority of patients do not experience complications or symptoms

The relationship between visible varicose-veins and common symptoms such as leg aching is uncertain.

There is no evidence that surgery on uncomplicated varicose-veins reduces long-term complications such as ulceration.

Consensus advice generally supports discretionary or conservative management of varicose veins.

Surgery is superior to compression hosiery alone in preventing recurrence of venous ulceration but not healing.

Compression improves healing of venous ulcers.

Recent evidence suggests improvements in symptoms and health-related quality of life for patients with uncomplicated varicose-veins with reflux when compared to conservative management, including compression hosiery. The cost-effectiveness of surgery compared to conservative treatment was within an acceptable range for the NHS.

The quality of life benefits of surgery for patients with uncomplicated varicose veins are relatively small.

Although surgery is effective, a trial of conservative treatment is warranted for uncomplicated disease to reduce the need for surgery in some patients, and confirm the relationship between symptoms and varicosities.

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Funding varicose-vein surgery for aesthetic reasons alone would be inconsistent with the PCTs position on other cosmetic procedures.

Evidence

A population study has suggested that symptoms attributable to varicose veins are common but their relationship to visible trunk-varices is not clear. (Bradbury et al)

There is only one RCT (n=246) comparing surgery with conservative treatment. This suggests benefit in terms of symptoms and quality of life at one year. The quality of life benefits were small but measurable and significant. The study experienced high loss-to-follow-up, and, by three years, over 50% of the conservative group had undergone surgery (Michaels et al, 2006)

A recent HTA report (April 2006) concluded that standard surgical treatment of varicose veins by saphenofemoral ligation, stripping and multiple phlebectomies is a clinically effective and cost-effective treatment for varicose veins, with an ICER well below the threshold normally considered appropriate for the funding of treatments within the NHS. Injection sclerotherapy also appears to be cost-effective, but produces less overall benefit, with a higher ICER than surgery for patients with superficial venous-reflux. In minor varicose veins without reflux, sclerotherapy is likely to provide a small average-benefit with acceptable cost-effectiveness.

RCT evidence supports compression as effective in improving healing of venous ulcers suggesting it can address the underlying pathophysiology of venous disease in the legs. (Cochrane Review)

A large recent RCT has shown that surgery is superior to compression alone in preventing recurrence of venous ulceration but not healing. This suggests that surgery addresses the underlying pathophysiology of venous disease in the legs and reduce complications among those at risk. (ESCHAR study)

References

Cullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcers. The Cochrane Database of Systematic Reviews 2001, Issue 2.

Bradbury A, Evans C, Allan P, Lee A, Ruckley CV, Fowkes FG. What are the symptoms of varicose veins? Edinburgh vein study cross sectional population survey. BMJ 1999;318:353–6.

Referral Advice: a guide to appropriate referral from general to specialist services. NICE 2001

J. Barwell, C. Davies, J. Deacon, K. Harvey, J. Minor, A. Sassano, M. Taylor, J. Usher, C. Wakely, J. Earnshaw Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial.  The Lancet, Volume 363, Pages 1854-1859

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J. A. Michaels, J. E. Brazier, W. B. Campbell, J. B. MacIntyre, S. J. Palfreyman, J. Ratcliffe. Randomized clinical trial comparing surgery with conservative treatment for uncomplicated varicose veins.British Journal of Surgery.Volume 93, Issue 2, 2006. Pages 175-181

J. Ratcliffe, J. E. Brazier, W. B. Campbell, S. Palfreyman, J. B. MacIntyre, J. A. Michaels Cost-effectiveness analysis of surgery versus conservative treatment for uncomplicated varicose veins in a randomized clinical trial British Journal of Surgery Volume 93, Issue 2, 2006. Pages 182-186

JA Michaels,1* WB Campbell,2 JE Brazier,3 JB MacIntyre,4 SJ Palfreyman,1 J Ratcliffe3 and K Rigby1 Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial)Health Technol Assess 2006;10(13):1–196

London N J M and Nash R.  ABC of arterial and venous disease. Varicose veins. BMJ. 2000 May 20;320(7246):1391-4

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Wisdom Teeth Removal

To avoid the removal of disease free wisdom teeth. Continue to implement NICE guidance that impacted wisdom teeth that are free from disease (healthy) should not be operated on.

Defintion

Wisdom teeth usually come through between the ages of 18 and 24 years. Sometimes as they come through they cause problems. The term used to describe wisdom teeth that don’t come through normally is impacted wisdom teeth. Two reasons for this are a lack of space, or other teeth being in the way. For most people impacted wisdom teeth cause no problems at all, but some people can suffer problems such as inflammation of the surrounding gum and a higher risk of tooth decay.

Evidence

Impaction of wisdom teeth is estimated to occur in up to 73% of people aged 20 – 29 years. Of these, it is estimated that 2-8% will have associated complications.

There is no evidence to support a health benefit to patients from prophylactic removal of pathology free impacted wisdom teeth. In contrast, there is a health benefit to patients from removal of wisdom teeth with associated pathology including relief of symptoms and prevention of progression of such problems as cyst formation andresorption of adjacent teeth.

Wisdom teeth removal is not without its dangers. The rate of complications after removing wisdom teeth is 12% in youths (age range 12-29) and 22% in older age (age range 25-81). These include nerve damage, damage to adjacent teeth, fracture of mandibular or maxillary tuberosity, swelling/airway problems. In addition, there are potential risks associated with undertreatment of those patients with problemssuch as recurrent pericoronitis and cyst formations.

1. National Institute for Clinical Excellence. Guidance on the Removal of Wisdom Teeth – Technology Appraisal Guidance No 1, March 2000http://www.nice.org.uk/nice-web/Embcat.asp?page=oldsite/appraisals/wis_guide.htm2. Hugoson A Kugelberg C F. The prevalence of third molars in a Swedish population epidemiological study: Community Dental Health 1988:5; 121-138.3. Shepherd J P, Brickley M. Surgical removal of third molars. British Medical Journa 1994:309; 620-621 http://www.bmj.com/cgi/content/full/309/6955/6204. Song F, Landes D P, Glenny A M. Sheldon T A. Prophylactic removal of impacted third molars: an assessment of published reviews. British Dental Journal 1997:182(9):339 – 346.5. Toth B. The appropriateness of prophylactic extraction of impacted third molars: a review of the literature. Health Care Evaluation Unit, University of Bristol 1993.

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6. Daley T D. Third molar prophylactic extractions: a review and analysis of the literature. General Dentistry 1996: 44(4); 310-320.7. Black’s Medical Dictionary. 40th Edition. A & C Black. London. 2002.

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Appendix 1LOW PRIORITY PROCEDURE REQUEST FORM

For approval of all exceptional cases where criteria do not apply

Please complete this form as soon as possible and email to the patient’s PCT.

PCT Commissioning number (for PCT use)Patient Details

DiagnosisCurrent condition

Proposed intervention

If relevant state where the patient is on the 18 week pathway

The applicant

NameSpecialtyTrust / UnitTelephone numberE-mail address

Patient’s GP

Patient’s GPGP’s address

GP’s telephone number

The patient and their condition

1. What is the approximate frequency (prevalence/incidence) of the condition?

2. What are the treatment goals for this patient?

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3. Please describe any special features of the condition in this patient that may influence the decision.

The intervention (this may be an operation or other procedure, a drug or another kind of therapy)4. Please describe the intervention, including long term follow up requirements.

5. Please provide the name of the service provider (trust or other organisation) who will supervise or carry out the intervention

6. Is this intervention already provided by another service provider ? If yes, please describe why the intervention should be provided by the service provider given in question 6.

7. Are there other treatments available for this condition? If so, please describe.

8. What is the cost of the intervention? Please include costs of:

A. Assessment

B. Treatment

C. Follow up

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9.What are the possible adverse effects of the intervention? Please provide quantitative information if possible.

Thank you for providing this information. Please email to:

For the NW London PCTs: Brent PCT - [email protected] Harrow PCT - [email protected] PCT - [email protected] Hillingdon PCT - [email protected]

For any patient outside these PCTs please contact the PCT in order to ascertain the correct e mail address.

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