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Low Priority Policy.doc.doc

  1. 1. Brent Teaching Primary Care Trust Working with our partners for a healthier Brent www.brentpct.nhs.uk Low Priority Procedures ProcessNW London Commissioning Consortium & North West London Hospital Trust
  2. 2. Low Priority Procedures Process North West London Hospital Trust1. IntroductionBrent PCT, in conjunction with its consortium PCTs, has identified in the 2008/09 contractcertain 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 inappropriate2. Agreed Process2.1 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: NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 2
  3. 3. • Brent PCT - Bre-pct.tosla@nhs.net • Harrow PCT - Har-pct.SLA@Nhs.net • Ealing PCT - carol.hall2@nhs.net • Hillingdon PCT - katrina.mindel@nhs.net • 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 CriteriaThe current low priority procedures list is identified below and reflects the list in the 2008/09 contractwith NWLHT. The existing criteria will be applied and any changes to the criteria will be subjectto negotiation. Additional procedures may be added to this list by referring it to Brent PCT andnegotiating it within the consortium. As the co-ordinating commissioner, it is Brent PCT’sresponsibility to ensure that NWLHT is informed of any changes.The most urgent areas identified for review relate to minor surgery and other procedures whereNWLH already operate more stringent criteria than set out (NWLH will continue to apply these inthe interim).4. Low Priority Procedures4.1 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 breast J01 B302 Revision of prosthesis for breast J01 B308 Prosthesis for breast OS J01 B309 Prosthesis for breast unspecified J01 B311 Reduction mammoplasty J01 B312 Augmentation mammoplasty J01 B313 Mastopexy J01 B314 Revision of mammoplasty J01 B356 Eversion of nipple J04 B302 Revision of prosthesis for breast J04 B308 Prosthesis for breast OS J04 B312 Augmentation mammoplasty J04 B314 Revision of mammoplasty J04 B356 Eversion of nipple J05 B302 Revision of prosthesis for breast J05 B308 Prosthesis for breast OS J05 B312 Augmentation mammoplasty J05 B314 Revision of mammoplasty NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 3
  4. 4. J05 B356 Eversion of nipple J06 B303 Removal of prosthesis for breast J07 B303 Removal of prosthesis for breast J07 S011 Facelift and tightening of platysma J07 S012 Facelift nec J07 S021 Abdominoplasty J07 S022 Abdominolipectomy J07 S031 Buttock lift J07 S032 Thigh lift J07 S211 Hair bearing flap skin to scalp for male pattern baldness J07 S212 Hair bearing flap of skin to scalp nec J07 S332 Hair bearing strip graft to scalp for male pattern baldness J07 S333 Hair bearing graft to scalp for male pattern baldness nec J29 S011 Facelift and tightening of platysma J29 S012 Facelift nec J29 S013 Submental lipectomy J29 S014 Browlift J29 S018 Plastic excision of skin of head or neck OS J29 S019 Plastic excision of skin of head or neck unspecified J29 S031 Buttock lift J29 S032 Thigh lift J29 S332 Hair bearing strip graft to scalp for male pattern baldness J29 S333 Hair bearing graft to scalp for male pattern baldness nec J32 S011 Facelift and tightening of platysma J32 S012 Facelift nec J32 S013 Submental lipectomy J32 S014 Browlift J32 S018 Plastic excision of skin of head or neck OS J32 S019 Plastic excision of skin of head or neck unspecified J32 S032 Thigh lift J32 S332 Hair bearing strip graft to scalp for male pattern baldness J32 S333 Hair bearing graft to scalp for male pattern baldness nec J33 S331 Hair bearing punch graft to scalp for male pattern baldness J33 S601 Dermabrasion of skin of head or neck J33 S602 Dermabrasion of skin nec J33 S621 Liposuction of subcutaneous tissue of head or neck J33 S622 Liposuction of subcutaneous tissue nec J34 S603 Tattooing of skin J34 S604 Refashioning of scar nec J35 S603 Tattooing of skin J35 S604 Refashioning of scar nec J50 B301 Insertion of prosthesis for breast J50 B302 Revision of prosthesis for breast J50 B308 Prosthesis for breast OS J50 B309 Prosthesis for breast unspecified J50 B311 Reduction mammoplasty J50 B312 Augmentation mammoplasty J50 B313 Mastopexy J50 B314 Revision of mammoplasty J50 B356 Eversion of nipple4.2 Procedures where criteria apply NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 4
  5. 5. PCTs will not fund these procedures unless they meet the criteria listed in the low prioritypolicy (annex A). It is expected that activity related to these procedures will reduce in line withthe level of activity of the best performing trusts nationally. It is the responsibility of referringand treating clinicians to ensure that only patients meeting the defined criteria are referred ortreated. The majority of ineligible patients should not be referred and thus adherence to thispolicy is the responsibility of the referring clinician. PCTs will monitor adherence to this policyvia monthly audit of the simple audit sheets in the patient’s notes. LOW PRIORITY PROCEDURES WHERE CRITERIA APPLY B17 C132 Blepharoplasty of upper eyelid B17 C133 Blepharoplasty of lower eyelid B17 C134 Blepharoplasty nec B18 C131 Blepharoplasty of both eyelids B18 C181 Correction of ptosis eyelid using levator muscle technique B18 C182 Correction of ptosis eyelid using frontalis muscle technique B18 C183 Correction of ptosis of eyelid using sling of fascia B18 C184 Correct ptosis eyelid using superior rectus muscle technique B18 C186 Correction of ptosis of eyelid using aponeurosis technique B18 C188 Correction of ptosis of eyelid OS B18 C189 Correction of ptosis of eyelid unspecified C21 D033 Pinnaplasty C21 D038 Plastic operations on external ear OS C21 D039 Plastic operations on external ear unspecified C21 D062 Repair of lobe of external ear C32 E025 Reduction rhinoplasty C32 E026 Rhinoplasty nec C32 E028 Plastic operations on nose OS C32 E029 Plastic operations on nose unspecified C56 E094 Shave of skin of nose J29 S021 Abdominoplasty J29 S022 Abdominolipectomy J29 S028 Plastic excision of skin of abdominal wall OS J29 S029 Plastic excision of skin of abdominal wall unspecified J32 S021 Abdominoplasty J32 S022 Abdominolipectomy J32 S028 Plastic excision of skin of abdominal wall OS J32 S029 Plastic excision of skin of abdominal wall unspecified J32 S031 Buttock lift L42 N181 REVERSAL OF BILATERAL VASECTOMY L43 N181 REVERSAL OF BILATERAL VASECTOMY M05 Q291 REANASTOMOSIS OF FALLOPIAN TUBE M05 Q292 OPEN REMOVAL OF CLIP FROM FALLOP M05 Q298 OTHER SPECIFIED M05 Q299 UNSPECIFIED ( femal sterilisation) M06 Q291 REANASTOMOSIS OF FALLOPIAN TUBE M06 Q292 OPEN REMOVAL OF CLIP FROM FALLOP M06 Q298 OTHER SPECIFIED M06 Q299 UNSPECIFIED ( femal sterilisation) M07 Q291 REANASTOMOSIS OF FALLOPIAN TUBE M07 Q292 OPEN REMOVAL OF CLIP FROM FALLOP M07 Q298 OTHER SPECIFIED M07 Q299 UNSPECIFIED ( femal sterilisation) M08 Q291 REANASTOMOSIS OF FALLOPIAN TUBE M08 Q292 OPEN REMOVAL OF CLIP FROM FALLOP NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 5
  6. 6. 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 prosthesisC60 D242 Implantation of extracochlear prosthesisH13 A651 Carpal tunnel releaseH13 A658 Release of entrapment of peripheral nerve at wrist OSH13 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 PrepuceplastyNWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 6
  7. 7. 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 necM07 Q073 Abdominal hysterocolpectomy necM07 Q074 Total abdominal hysterectomy necM07 Q075 Subtotal abdominal hysterectomyM07 Q078 Abdominal excision of uterusM07 Q079 Abdominal excision of uterus unspecifiedM07 Q081 Vaginal hysterocolpectomy and excision of periuterine tissueM07 Q082 Vaginal hysterectomy and excision of periuterine tissue necM07 Q083 Vaginal hysterocolpectomy necM07 Q088 Vaginal excision of uterus OSM07 Q089 Vaginal excision of uterus unspecifiedQ11 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 veinQ11 L872 Stripping of short saphenous veinQ11 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 legQ11 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 necNWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 7
  8. 8. Annex A Low Priority Procedures Policy ContentsAesthetic Surgery.........................................................................12Circumcision...............................................................................21Cochlear Implants.........................................................................22Surgery for Carpal Tunnel Syndrome...................................................24Dental Implants............................................................................26Grommets..................................................................................28HOMEOPATHY..............................................................................30Hysterectomy for Heavy Menstrual-Bleeding.........................................32Minor Skin Lesions.........................................................................34Reversal of Sterilisation..................................................................35Tonsillectomy..............................................................................36Varicose Veins.............................................................................37Wisdom Teeth Removal..................................................................40Diagnosis....................................................................................41The intervention (this may be an operation or other procedure, a drug oranother kind of therapy).................................................................42 IntroductionPolicy statementPCTs are required to improve and care for the health of their populationswithin a limited financial envelope. It is therefore appropriate for PCTs toensure that the most effective use is made of the resources they have. Thisimplies a priority setting culture where the access to some treatments orprocedures, 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 listof low priority procedures which will only be funded on an exceptional basis orwhere patients have been treated or investigated within defined referral ortreatment criteria. The list follows this policy introduction. This list includestwo categories of procedure:1. Those which, as routine are not provided by the PCT and where provision isonly possible on an individual patient basis, via the referral of the case by therelevant clinician to the PCT Treatment Outside of Service Level Agreementpanel (TOSLA panel). These are listed as “PARTIALLY EXCLUDED PROCEDURE”2. Those which may be offered on a routine basis but only for patients whomeet defined criteria. These are listed as “THRESHOLD APPLIES”NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 8
  9. 9. Ethical frameworkThe principles on which this low priority procedure policy is built andimplemented should be embedded within a transparent and reasonable ethicalframework. These principles include:Benefit vs. harm - If there is insufficient evidence that a treatment confers abenefit 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 basisEquity/justice - the PCT should aim to provide equal access to treatments forall 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 effectivenessPatient choice/autonomy – patients should have a right to request treatmentsand 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 appealsReferral proceduresPartially excluded proceduresPartially excluded procedures should not be referred for treatment or placedon treatment waiting lists without the approval of the Brent PCT TOSLA Panel.The TOSLA panel will assess the criteria on the basis of the informationsupplied on the TOSLA form. This panel meets monthly. Exceptionally, casesmay be discussed between meetings.Referrals to the TOSLA panel can only be made on an individual, named patientbasis and must be made by an appropriate referring clinician. Decisions madeby the panel will relate to the individual patient only and are not an indicationof PCT policy or precedent for the provision this procedure. Neither areNWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 9
  10. 10. positive decisions an absolute approval for the treatment to go ahead, theclinical decision for which must rest with the clinician to whom the patient isreferred in consultation with the patient themselves.Thefollowing 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: • 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 anticipatedAppeals processIn the case of a negative decision the patient and/or clinician will have theright 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 correctlyAll 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 acomplaint about funding through the statutory NHS complaints procedure.Procedures where thresholds applyIt is the responsibility of referring and treating clinicians to ensure that onlypatients meeting the defined criteria are referred or treated. The majority ofNWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 10
  11. 11. ineligible patients should not be referred and thus adherence to this policy isthe responsibility of the referring clinician.In the minority of cases it is recognised that a specialist opinion is neededbefore eligibility can be determined. In these cases it is the responsibility ofthe receiving clinician to ensure that threshold policies are adhered to and thatreferring clinicians are informed that they must receive the ineligible patientback into their care.Audit and monitoringPCTs will monitor adherence to this policy on a regular basis. This will be via:• 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 careAddition of procedures to the policyAdditions will be made no more frequently than every six months. The BrentPCT Commissioning Steering Group will recommend additions to the policybased on evidence of effectiveness and local information on practice, activityand financial burden.Policy reviewEach low priority procedure has a review date. These are annual unlessotherwise specified. Any amendments will be ratified by Brent PCT Board andcommunicated to stakeholders.Availability of policiesAll policies will be available on Brent PCT website and any amendmentsflagged.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 11
  12. 12. Aesthetic SurgeryIntroductionThe aim of these guidelines is to provide effective criteria that allow requestsfor aesthetic surgery/interventions to be limited to patients in high-needgroups. 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 PlasticSurgery ‘Information for Commissioners of Plastic Surgery Services. Referralsand 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 ofthe 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 contractexclusions/other policies in aesthetic surgery in Brent. However, some of thedecisions about procedures might have been taken by ‘consensus view’ ratherthan on an evidence-base. Previous Brent guidelines have sought to preventthe 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 importantsurgical outcome. It occurs, therefore, that much surgery that is not aestheticwill have cosmetic components.In view of these considerations, some modifications have been made to thenational guidelines (these are highlighted by a ** in the table below). TheseNWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 12
  13. 13. changes are principally in areas where the national guidelines may beinsufficiently robust or would represent a service development in a low priorityarea, and are intended to give PCTs greater control over exclusions. Examplesfrom 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).NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 13
  14. 14. 1) Procedure 2) Patient group that may be 3) Actions that need to be 4) Contra- considered for funding of surgery undertaken before indications consideration of surgery to surgery in patients who fall into patient group in column 2).Female breast This procedure will not normally be 1) Symptoms not relieved by Body massreduction funded. Exceptional circumstances wearing a fitted brassiere (fitted index greater only.** by trained bra fitter). than or equal to 30.Breast enlargement This procedure will not normally be If surgery is to be performed,(Augmentation funded. Exceptional circumstances patients undergoing breastmammoplasty) only.** augmentation should: 1) be encouraged to participate in the UK national breast implant registration system; 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’ Will not normally be funded**(apronectomy or The exceptions panel will considerabdominoplasty) whether or not the patient fulfills the criteria outlined below. Patient groups: • scarring following trauma or previous abdominal surgery; • patients undergoing treatment for morbid obesity who have excessive skin folds; • previously obese patients, who have lost a large amount of weight and maintained the loss for at least NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 14
  15. 15. 1) Procedure 2) Patient group that may be 3) Actions that need to be 4) Contra- considered for funding of surgery undertaken before indications consideration of surgery to surgery in patients who fall into patient group in column 2). two years; • as part of abdominal hernia correction or other abdominal 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 disabling psychological distress or risk of infection; • poorly-fitting stoma bags.Breast lift This procedure will not normally be(Mastopexy) funded. Exceptional circumstances only. **Male Breast Post pubertal patients with 1) Male breast cancer should not BMI > 25 kg/Reduction for severe** gynaecomastia. be mistaken for gynaecomastia. m2.Gynaecomastia Pre-authorisation is required from If there is any doubt, urgent(Liposuction may the PCT. Approval will only be specialist consultation should beform part of the given for post-pubertal males, who obtained.treatment plan for are of normal height weight ratio,this condition) when the proposed volume of 2) Screen for endocrinological reduction is greater than 200g per and drug related causes and/or side or for gross asymmetry’** psychological distress. NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 15
  16. 16. 1) Procedure 2) Patient group that may be 3) Actions that need to be 4) Contra- considered for funding of surgery undertaken before indications consideration of surgery to surgery in patients who fall into patient group in column 2).Revision of Breast Revision surgery will only OriginalAugmentation considered if the NHS implant not commissioned the original surgery carried out (e.g. post malignancy)** on NHS. 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**Nipple Inversion This procedure will not normally be 1) Nipple inversion may occur as funded. Exceptional circumstances a result of breast malignancy; it only** is essential that this be excluded. 2) Use of a non-invasive suction device.Face lifts and brow These procedures will be Not to treatlifts (Rhytidectomy) considered for the treatment of: the natural processes of • congenital facial abnormalities; ageing. • facial palsy; • treatment of rare specific conditions affecting the facial skin, e.g. cutis laxa, pseudoxanthoma elasticum, neurofibromatosis; • deformity following surgery. • when trauma is the indication for surgery, this must be considered via the TOSLA panel.** NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 16
  17. 17. 1) Procedure 2) Patient group that may be 3) Actions that need to be 4) Contra- considered for funding of surgery undertaken before indications consideration of surgery to surgery in patients who fall into patient group in column 2).Surgery on the To correct functional impairment Not purelyupper eyelid including: for cosmetic(Upper lid reasons.blepharoplasty) 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.Surgery on the Available for: Excessivelower eyelid skin in the(Lower lid 1) correction of ectropion or lower lid mayblepharoplasty) entropion cause ‘eyebags’, 2) Removal of lesions of the eyelid but, does not skin or lid margin. affect eyelid function or vision and, therefore, does not need correction.Surgery to reshape Problems caused by obstruction of Prior ENT consultation may bethe nose the nasal airway must be considered for patients with(Rhinoplasty) considered by the exceptions isolated airway problems (in the route.** absence of visible nasal deformity). 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). NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 17
  18. 18. 1) Procedure 2) Patient group that may be 3) Actions that need to be 4) Contra- considered for funding of surgery undertaken before indications consideration of surgery to surgery in patients who fall into patient group in column 2).Correction of This procedure will not normally be • Patient should be seen by aprominent ears funded. Exceptional circumstances plastic surgeon, and, following(Pinnaplasty / only.** assessment, if there is anyOtoplasty) 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 Repair of completely split ear Advice regarding:ear lobes (lobules) lobes as a result of direct trauma. • 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 Usually available. Some suchcongenital conditions are highly specialisedanomalies of the and are commissioned in the UKface and skull through NSCAG.Correction of post Is available on the NHS.traumatic bony andsoft tissuedeformity of thefaceCorrection of hair Available on NHS only when theloss (Alopecia) result of previous surgery or trauma, including burns.Correction of male Is excluded from treatment by thepattern baldness NHS.Hair This procedure will not normally betransplantation funded. Exceptional circumstances only.**Other skin excision This procedure will not normally befor contour e.g. funded. Exceptional circumstancesButtock lift, Thigh only.**lift, Arm lift(brachioplasty) NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 18
  19. 19. 1) Procedure 2) Patient group that may be 3) Actions that need to be 4) Contra- considered for funding of surgery undertaken before indications consideration of surgery to surgery in patients who fall into patient group in column 2).Liposuction This procedure will not normally be funded. Exceptional circumstances . only.**Minor skin lesions Minor skin lesions are covered in a(benign pigmented separate section of this document.moles,comedones,corn/callous,lipoma,milia,molluscumcontagiosum,sebaceous cysts(epidermoid or pilarcysts),seborrhoeickeratoses (basal cellpapillomata),skin tags includinganal tags,spider naevus(telangiectasia),warts,xanthelasma,neurofibromata)Tattoo removal This procedure will not normally be funded. Exceptional circumstances only.**Skin hypo- This procedure will not normally be Cosmetic camouflage ispigmentation funded. Exceptional circumstances recommended treatment. This only.** should be by access to a qualified camouflage beautician.Vascular skin This includes treatment of portlesions wine stains on head and neck. **Treatment of small, This procedure will not be funded.benign, acquired,vascular lesionssuch as threadveins and spidernaevi. NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 19
  20. 20. 1) Procedure 2) Patient group that may be 3) Actions that need to be 4) Contra- considered for funding of surgery undertaken before indications consideration of surgery to surgery in patients who fall into patient group in column 2).Acne vulgaris This procedure will not normally be The treatment of active acne(resurfacing funded. Exceptional circumstances vulgaris should be provided inand other surgical only.** primary care orinterventions for by a dermatology service.scarring)Rhinophyma PCTs should not fund any surgical or laser treatment for rhinophyma except in exceptional circumstancesSkin resurfacing This procedure will not normally betechniques funded. Exceptional circumstances(including laser, only.**dermabrasion andchemical peels)Botulinum toxin Treatment of pathological Not available conditions by appropriate for the specialists, for example in: treatment of • Blepharospasm; facial ageing • Cerebral palsy. or excessive wrinkles.Hair depilation This procedure will not normally be(hair removal) funded. Exceptional circumstances only.**Gender Patients should be referred toreassignment recognized NHS programme ofsurgery care for management of these cases. Each case should be considered on its individual merits. NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 20
  21. 21. CircumcisionCircumcision is a surgical procedure that involves partial or complete removalof the foreskin (prepuce) of the penis.Circumcision is considered a low priority treatment. It should only be fundedby the NHS for medical reasons, and not for religious or social reasons.Medical indications for circumcision are (subject to specialist surgicalassessment and advice): phimosis in children with spraying, ballooning and/ orrecurrent infection; adult phimosis; recurrent balanitis; balantitis xertoticaobliterans; paraphimosis; suspicion or evidence of malignancy; dermatologicaldisease (such as lichen planus or eczema) which is unresponsive to othertreatment; where biopsy is required; and occasionally for selected patientswith urinary tract infections (normally referred by a paediatrician).EvidenceThere is much debate currently in the medical literature about circumcision.There are claims that there may be health benefits associated with thisprocedure, for example, a lower rate of penile cancer and a reduced chance ofsexual transmitted diseases including HIV. However, the evidence isinconclusive.Haemorrhage and infection are well-recognised complications. In addition, inthe long-term, problems such as psychological trauma and possible decreasedsexual pleasure have been reported.Glossary:Phimosis - a tight ring often made of scar tissue preventing retraction of theforeskin, which may be primary, or secondary to recurrent infectionBalanitis - infection of the glans/ glans and foreskinBalantitis xertotica obliterans - lichen sclerosis primarily affecting the foreskinParaphimosis – Inability to replace the foreskin after retractionREFERENCES1. Davenport M (1996). ABC of General Surgery in Children: Problems with the Penis and Prepuce. BMJ1996; 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 (Denmark1943-90). 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. (September1997). 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.htm5. Szabo R et al. Education and Debate, How Does Male Circumcision Protect Against HIV Infection? BMJ2000, 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.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 21
  22. 22. Cochlear ImplantsThe PCT will fund cochlear implantation in those people meeting the followingcriteria: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 discriminationIn 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 aidsDefinitionA cochlear implant is a sophisticated hearing aid which stimulates the cochlearnerve directly. A cochlear implant improves the ability to hear environmentalsounds such as cars, doorbells, and pets, and to hear rhythms and patterns ofspeech, thus improving speech recognition. The technology is continuallyimproving and now in some cases hearing improves enough to allow telephoneconversation. The implantation itself is a relatively simple surgical procedure,but the overall process involves a complex series of pre-operativeinvestigations 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 • 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.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 22
  23. 23. 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 aidsReferencesSchorr, E.A., N.A. Fox, et al. In press. Auditory-visual fusion in speech perception in childrenwith cochlear implant. Proceedings of the National Academy of Sciences. Abstract available athttp://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 thecentral auditory system in children with cochlear implants: Implications for age of implantation.Ear & Hearing 23(December):532-539. AbstractFrancis HW, Niparko JK. Cochlear implantation update; Pediatr Clin N Am 2003; 50:341-361Cohen NL. Cochlear Implant Candidacy and Surgical Considerations; Audiol Neurootol. 2004;9(4):197-202.West Sussex PCTs PCTs Cochlear Implant PolicyCambridgeshire and Peterborough Public Health Network Cochler Implants PolicyBritish Cochlear Implant Group http://www.bcig.orgThe National Deaf Children’s Societyhttp://www.ndcs.org.uk/about_ndcs/ndcs_policies_campaigns/ndcs_policies/cochlear_implant.htmlNWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 23
  24. 24. 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) 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)NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 24
  25. 25.  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.ReferencesLy-Pen D, Andreu JL, de Blas G, Sanchez-Olaso A, Millan I. Surgical decompression versus local steroidinjection in carpal tunnel syndrome: a one-year, prospective, randomized, open, controlled clinical trial.Arthritis Rheum 2005;52: 612-9J W H H Dammers, M M Veering, and M Vermeulen, Injection with methylprednisolone proximal to the carpaltunnel: 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 Arandomized 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 CochraneDatabase of Systematic Reviews 2002, Issue 4.OConnor D, Marshall S, Massy-Westropp N. Non-surgical treatment (other than steroid injection) forcarpal tunnel syndrome. The Cochrane Database of Systematic Reviews 2003, Issue 1.Verdugo RJ, Salinas RS, Castillo J, Cea JG. Surgical versus non-surgical treatment for carpal tunnelsyndrome. The Cochrane Database of Systematic Reviews 2003, Issue 3Sevim S, Dogu O, Camdeviren H, Kaleagasi H, Aral M, Arslan E, Milcan A Long-term effectiveness of steroidinjections 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 thetreatment 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 splintingin carpal tunnel syndrome. Am J Phys Med Rehabil. 2002 Mar;81(3):182-6.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 25
  26. 26. Dental ImplantsDental implants are considered a low priority procedure and will only befunded for patients with maxillofacial defects resulting from developmental orcongenital 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 theFaculty 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.DefinitionAn endosseous dental implant is a surgically implanted device which replacesthe lost roots of a tooth. An artificial tooth, partial denture, or denture can beattached to the implant. Traditional procedures for replacing missing teethinclude partial dentures, complete removable dentures, or fixed bridges thatattach to existing teeth or rest on the gums. However, for individuals wherethis is not successful, eg those who have a weakened jawbone, who cannotmanage removable dentures or cannot properly chew food, implants may be apreferred option.RationaleThe Faculty of Dental Surgery has produced guidance on the selection ofpatients for dental implant treatment within the NHS. These include threegroups 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 consideredbefore proceeding to dental implant treatment is provided. It is recommendedthat treatment outcomes for those receiving implants be audited.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 26
  27. 27. EvidenceDental implants have been shown to be a successful treatment for replacingmissing teeth by providing support for fixed bridge prostheses, individualcrowns, and overdentures. Evidence from randomised controlled trials showsincreased ability to chew tough food, and increased patient satisfaction withimplants in comparison to normal dentures.Complications of implant surgery include swelling, pain, bleeding, possibleinfection, and partial numbness at implant site. Nerve disturbances that maybe permanent and bone fracture can occur, as can rejection of the implant.However, severe complications are rare.References1.Guidelines for selecting appropriate patients to receive treatment with dental implants: Prioritiesfor the NHS. Faculty of Dental Surgery, National Clinical Guidelines 1997, Royal College ofSurgeons.2. Lekholm U. The Surgical Site. In Lindhe J, Karring K and Lang NP (eds). ClinicalPeriodontology 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. TheInternational 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 fixedprosthesis 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 ReceiveTreatment With Dental Implants: Priorities For The NHShttp://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 implantrehabilitation on health related quality of life in a randomised controlled clinical trial. J Dent Res2000; 79(9): 1659-63.8. Jonsson B, Karlsson G. Cost-benefit evaluation of dental implants. Int J Technol Assess HealthCare 1990; 6(4): 545-57.9. Goodacre CJ, Kan JY, Rungcharassaeng K. Clinical Complications of OsseointegratedImplants. The Journal of Prosthetic Dentistry 1999; 81(5): 537-52.10. The Consort Group, The Consort Statement: revised recommendations for improving thequality 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 Nationalepour le Developement de l’Evaluation Medicale. L’Agence Nationale d’Accreditation d’Evaluationen Sante (ANAES). 1993; 87.13. Creugars N H, Kreulin C M, Snoek P A, de Kanter R J. A systematic review of single-toothrestorations 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.pdfNWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 27
  28. 28. GrommetsThe PCT will agree to fund treatment with grommets for children with otitismedia 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 periodAND  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 drumRationaleEvidence of effectiveness is limited: surgery may resolve glue ear andimprove hearing in the short term, but there is less certainty about long-termoutcomes 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, particularlyin younger children.Timing of surgery may not be critical. A 1999 trial compared 9 monthswatchful waiting with immediate surgery and found outcomes to be similar by18 months (by this time, however, 85% of children in the watchful waitinggroup had been treated with grommets).The benefits of surgery have to be balanced against possible harms. Aboutone third of children who have grommets have complications. Tympanosclerosisfrequently occurs after grommet insertion, infection may occur, and there is aslightly increased incidence of chronic perforation.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 28
  29. 29. The reduced risk of serious complications of anaesthesia and surgery mustbe balanced against the increased hearing loss and episodes of infectionrequiring antibiotic treatment and time off work, school or college.Restricting access to grommets is not a new phenomenon: a 1995 surveyrevealed that 23 of the 129 then health authorities in England, Scotland andWales had excluded grommets.EvidenceCochrane review: Grommets for hearing loss associated with otitis media witheffusionLous J, Burton MJ, Felding JU, Ovesen T, Rovers MM, Williamson IConclusion:The benefits of grommets in children appear small. The effect of grommets on hearingdiminished during the first year. Potentially adverse effects on the tympanicmembrane are common after grommet insertion. Therefore an initial period ofwatchful waiting seems to be an appropriate management strategy for most childrenwith OME. As no evidence is yet available for the subgroups of children with speech orlanguage delays, behavioural and learning problems or children with defined clinicalsyndromes (generally excluded from the primary studies included in this review), theclinician will need to make decisions regarding treatment for such children based onother evidence and indications of disability related to hearing impairment.BMJ Clinical Evidence: Otitis media with effusionWilliamson ISummary:One systematic review found that grommets improved hearing at up to 2 years, butnot at 5 years compared with no grommets. The clinical significance of theimprovement seen (<10dB) was unclear. The review found that grommets did notsignificantly improve cognition, language comprehension or expression compared withno grommets, although relatively insensitive outcomes may have been used. Grommetswere associated with an increased risk of tympanosclerosis at 1 year. One systematicreview found that grommets plus adenoidectomy improved hearing at 6 monthscompared with no treatment, although the difference between the groups wasreduced at 12 months. The review found no significant difference between thecombined treatment and grommets alone at up to 12 months. Another review foundthat the combined treatment improved hearing more than adenoidectomy alone at upto 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 witheffusion and hearing loss of =<25 dB, but no speech and language, development orbehavioural problems, can be safely managed with watchful waiting. If watchfulwaiting is being considered, the child should undergo audiometry to exclude a moreserious degree of hearing loss.B: Children with persistent bilateral otitis media with effusion who are over threeyears of age or who have speech and language, developmental or behaviouralproblems should be referred to an otolaryngologist.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 29
  30. 30. HOMEOPATHYThese procedures will not normally be commissioned unless there areexceptional circumstances.RationaleBrent Primary Care Trust has considered the question of funding forhomeopathy and reviewed best available evidence for clinical effectiveness ofhomeopathy treatments. This included high quality review papers from peerreview journals.Homeopathy has not been proved to be efficacious beyond the placebo for anyone particular treatment by independently randomised control trials. Until thisevidence 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 terminatedEvidenceA number of meta-analyses have been published. The majority conclude thatthere is insufficient evidence for specific homeopathic remedies for specificclinical conditions (2-7). When compared with studies into conventionaltreatments, homeopathy studies show weak specific effects in contrast to thestrong effects of allopathic interventions (8). These findings are compatiblewith the conclusion that the clinical effects of homoepathy are partlyattributable to placebo. Although there is some evidence that homeopathictreatments are more effective than placebo, this evidence is weak as it comesfrom poor quality studies (9). Until more rigorous randomised trials onparticular preparations for specific conditions are available, it is not possible torecommend the use of homeopathy.References1. Effective Health Care : Homeopathy 2002 7(3)http://www.york.ac.uk/inst/crd/ehc73.pdf2. Bandolier (1997) Homeopathy-dilute information and little knowledge. Bandolier 1997,pp.42-53. Ernst E, Pitler MH (1998) Efficacy of homeopathic arnica: A systematic review of placebo andcontrolled clinical trials. Archives of Surgery 133:11: 1187-904. 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.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 30
  31. 31. 6. Reilley D (1994) Is the evidence for homeopathy reproducible? Lancet: 334:1601-67. Vickers A (1999) Homeopathic Oscilloccinum for preventing and treating influenza andinfluenza like syndromes. Cochrane review 1999.8. Shang A, et al. (2005) Are the clinical effects of homeopathy placebo effects? Comparativestudy of placebo-controlled trials of homeopathy and allopathy. The Lancet; 366 726-7329. Cucherat M, et al (2000) Evidence of clinical efficacy of homeopathy. Europeanjournal of clinical pharmacology. 56(1) April 27-33.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 31
  32. 32. Hysterectomy for Heavy Menstrual-BleedingPCTs will fund hysterectomy for heavy menstrual-bleeding only when:There has been a prior trial with a LNG-IUS intra-uterine device (unlesscontraindicated) which this has not successfully relieved symptomsANDOther 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 immunosuppressionRationale 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-indicatedEvidence NICE released draft guidelines on heavy menstrual-bleeding (HMB) in July 2006, and these form the basis of these proposals. The proposals will be reviewed, when final guidelines are released by NICE (this is expected to be in January 2007).NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 32
  33. 33.  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.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 33
  34. 34. Minor Skin LesionsPCTs will fund removal of benign minor dermatological lesions where there is asuspicion of malignancy OR obstruction of orifice or vision OR functionallimitation on movement or activity.PCTs will consider funding of the removal of moderate to large facial lesionswhich 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 PCTsubject 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  NeurofibromataRationale  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.ReferencesAction on referral and guidelines in plastic surgery. NHS Modernisation AgencyNWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 34
  35. 35. Reversal of SterilisationReversal of sterilisation is considered a low priority treatment and will notnormally be provided under the NHS. Sterilisation is provided under the NHS onthe understanding that it is an irreversible procedure. Patients are informedand written consent is sought before the operation is carried out.It is recommended that thorough counselling be given to the patient and thatthe patient (and partner) have clear understanding before proceeding withsterilisation or vasectomy, ensuring that the patient is fully aware of currentlocal NHS policy of not normally funding reversal of sterilisation andvasectomy.It is recommended that sterilisation or vasectomy are not normally performedon those under 30, those who appear to be unstable or in conflict relationshipsand that sterilisation is not performed during caesarean section. Exceptions tothese can be assessed during counselling.Sterilisation is a procedure by which a person is rendered permanently unableto produce children. This is called vasectomy in men and operative occlusion ofthe fallopian tubes in women. Reversal of sterilisation is a surgical procedurethat involves the reconstruction of the fallopian tubes in women and vasdeferens in men.EvidenceHealth benefits: The need for reversal of sterilisation is not a life threateningcondition, but the procedure may improve quality of life. Counselling beforesterilization 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 pelvicarea of the abdomen, which are attached at one end to the uterus and havethe other unattached, but lying close to the ovary.Vas deferens: A narrow tube that leads from each testicle.References1. Royal College of Obstetricians and Gynaecologists. Guideline summary - Male andFemale Sterilisation,February 1998 www.rcog.org.uk2. Grew R. Reversal of sterilisation. North Essex Health Authority low priorities policy,18 February 1999.3. Dorland’s Illustrated Medical Dictionary, 27th ed, W B Saunders 1988.4. Black’s Medical Dictionary. 40th Edition. A & C Black. London. 2002.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 35
  36. 36. TonsillectomyPCTs will not ordinarily fund tonsillectomy except in cases of suspectedmalignancy or significant severe impact on quality of life indicated by at least 7episodes in the preceding year or 5 episodes/year in the preceding 2 years, or 3episodes/year in the preceding 3 years and documented evidence of absencefrom 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 guidelinesSources:Cochrane Database of Systematic Reviewshttp://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD001802/frame.htmlAdenotonsillectomy for upper respiratory infections:evidence based? Arch Dis Child 2005;90:19–25Sign Clinical Guidelines for Obstructive Sleep Apnoeahttp://www.sign.ac.uk/pdf/sign73.pdf NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 36
  37. 37. Varicose VeinsThe PCT will fund surgery on lower-limb varicose-veins due to venous reflux wherethere 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 hosieryThe PCT will not fund surgery for uncomplicated varicose vein where there are nosignificant physical symptoms or surgery for reticular veins or telangiectasia.All referrals should be through an agreed pathway to optimise access toconservative 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. NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 37
  38. 38.  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)ReferencesCullum N, Nelson EA, Fletcher AW, Sheldon TA. Compression for venous leg ulcers. TheCochrane Database of Systematic Reviews 2001, Issue 2.Bradbury A, Evans C, Allan P, Lee A, Ruckley CV, Fowkes FG. What are the symptomsof varicose veins? Edinburgh vein study cross sectional population survey. BMJ1999;318:353–6.Referral Advice: a guide to appropriate referral from general to specialist services.NICE 2001J. 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 compressionalone in chronic venous ulceration (ESCHAR study): randomised controlled trial. TheLancet, Volume 363, Pages 1854-1859J. A. Michaels, J. E. Brazier, W. B. Campbell, J. B. MacIntyre, S. J. Palfreyman, J.Ratcliffe. Randomized clinical trial comparing surgery with conservative treatmentfor uncomplicated varicose veins.British Journal of Surgery.Volume 93, Issue 2, 2006.Pages 175-181 NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 38
  39. 39. J. Ratcliffe, J. E. Brazier, W. B. Campbell, S. Palfreyman, J. B. MacIntyre, J. A.Michaels Cost-effectiveness analysis of surgery versus conservative treatment foruncomplicated varicose veins in a randomized clinical trial British Journal ofSurgery Volume 93, Issue 2, 2006. Pages 182-186JA Michaels,1* WB Campbell,2 JE Brazier,3 JB MacIntyre,4 SJ Palfreyman,1 J Ratcliffe3and K Rigby1 Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial)Health Technol Assess2006;10(13):1–196London N J M and Nash R. ABC of arterial and venous disease. Varicose veins. BMJ.2000 May 20;320(7246):1391-4NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 39
  40. 40. Wisdom Teeth RemovalTo avoid the removal of disease free wisdom teeth. Continue to implement NICEguidance that impacted wisdom teeth that are free from disease (healthy)should not be operated on.DefintionWisdom teeth usually come through between the ages of 18 and 24 years. Sometimesas they come through they cause problems. The term used to describe wisdom teeththat don’t come through normally is impacted wisdom teeth. Two reasons for this area lack of space, or other teeth being in the way. For most people impacted wisdomteeth cause no problems at all, but some people can suffer problems such asinflammation of the surrounding gum and a higher risk of tooth decay.EvidenceImpaction of wisdom teeth is estimated to occur in up to 73% of people aged 20 – 29years. 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 removalof pathology free impacted wisdom teeth. In contrast, there is a health benefit topatients from removal of wisdom teeth with associated pathology including relief ofsymptoms 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 afterremoving wisdom teeth is 12% in youths (age range 12-29) and 22% in older age (agerange 25-81). These include nerve damage, damage to adjacent teeth, fracture ofmandibular or maxillary tuberosity, swelling/airway problems. In addition, there arepotential 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 WisdomTeeth – 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 populationepidemiological study: Community Dental Health 1988:5; 121-138.3. Shepherd J P, Brickley M. Surgical removal of third molars. British Medical Journa1994:309; 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 impactedthird molars: an assessment of published reviews. British Dental Journal1997:182(9):339 – 346.5. Toth B. The appropriateness of prophylactic extraction of impacted third molars: areview of the literature. Health Care Evaluation Unit, University of Bristol 1993.6. Daley T D. Third molar prophylactic extractions: a review and analysis of theliterature. General Dentistry 1996: 44(4); 310-320.7. Black’s Medical Dictionary. 40th Edition. A & C Black. London. 2002.NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 40
  41. 41. Appendix 1 LOW PRIORITY PROCEDURE REQUEST FORM For approval of all exceptional cases where criteria do not applyPlease complete this form as soon as possible and email to the patient’s PCT.PCT Commissioningnumber (for PCT use)Patient DetailsDiagnosisCurrent conditionProposed interventionIf relevant state wherethe patient is on the18 week pathwayThe applicantNameSpecialtyTrust / UnitTelephone numberE-mail addressPatient’s GPPatient’s GPGP’s addressGP’s telephone numberThe patient and their condition1. What is the approximate frequency (prevalence/incidence) of the condition?2. What are the treatment goals for this patient? NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 41
  42. 42. 3. Please describe any special features of the condition in this patient that mayinfluence 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) whowill supervise or carry out the intervention6. Is this intervention already provided by another service provider ? If yes, pleasedescribe why the intervention should be provided by the service provider given inquestion 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. AssessmentB. TreatmentC. Follow up NWLHT Commissioning Consortium Low Priority Procedure Process 17 7 08 42