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Service Restriction Policy Version 1: Ratified by: Date ratified: Author Executive Sponsor Lead Director September 2015 Mid Essex CCG September 2015 Paula Wilkinson-Chief Pharmacist Dr. Donald McGeachy-Medical Director Dan Doherty-Director of Clinical Commissioning Name/Title of responsible committee/individual: Mid Essex CCG Clinical Commissioning Committee Mid Essex CCG Board 12th February 2016 September 2016 Version 5 Date issued: Review date: GPs, Optometrists, Dentists, Secondary care consultants, Central Referral Service Triagers, Public and Patients Target audience Version Control Version Version 1 Version 2 Version 3 Version 4 Version 5 Version 6 Key Changes Restoration of criteria for apronectomy, pinnaplasty, breast implants; clarification of cosmetic surgery statement; criteria for referral to specialist obesity services; removal of collagenase. Referral for assessment of bariatric surgery Patient has completed a Tier 2 weight management course within the last 12 months.change from 6 months Inclusion of restriction of vasectomy and female sterilisation- not routinely funded Inclusion of continuous glucose monitoring-not routinely funded Restoration of SRP for snoring- omitted from this document in error. Authorisation CCG Board Clinical Commissioning Committee and Board. Clinical Commissioning Committee CCG Board Clinical Commissioning Committee Clinical Commissioning Committee 1 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Document Summary Mid Essex CCG’s policy is that treatments/ interventions/ procedures not currently included in commissioned established care pathways (as identified for example in the Schedules to the service agreements with acute care provides) or identified for funding through the commissioning process are not routinely funded. For a number of commissioned interventions the CCG has specific policy statements setting out restrictions on access, based on evidence of effectiveness or relative priority for funding. Those related to treatments/ interventions/ procedures are included within this document; those relating to prescribing can be found on the Mid Essex CCG website Medicines Optimisation- . Providers must not assume that because a treatment/intervention/procedure is not included in this policy that by default it will be funded. Policy development is an on-going process and future policy on further treatments as developed or in response to NICE Guidance/Guidelines, health technology assessments etc. will be produced and published periodically on the CCG website-Service Restriction Policies Each new referral, regardless of advice provided following a previous referral or episode of care, must be assessed against the policy in place on the date the referral is made. The fact that a patient has previously been treated for the referral condition, or a related condition, and previously met the policy in place at the time does not support a referral or treatment outside the current service restriction policy. This policy document sets out the access to treatments/ interventions/ procedures* where there is a specific policy in place: Threshold Approvals – Those procedures* which are commissioned by Mid Essex CCG on a routine basis but only for patients who meet the defined criteria set out within this policy but for which individual prior approval is not required e.g. cataract surgery. CCG notification of compliance or audit will be required according to contractual arrangements. Providers should be aware that payment may be withheld where it cannot demonstrate that patients treated meet the criteria specified. Individual Prior Approvals - Those procedures* which are commissioned by Mid Essex CCG but only for patients who meet the defined criteria set out within this policy and which require individual approval on a patient by patient basis. For these procedures, the criteria listed form guidance to both the referring and treating clinicians and if a patient is deemed to meet these criteria prior approval should be sought. In instances in which eligibility is unclear the final decision is made through the application of the Exceptional Cases process. Not Funded – Those procedures* which have been assessed as Low Clinical Priority by Mid Essex CCG and which will not be funded unless there are exceptional clinical circumstances. Applications for funding for these procedures can be made to the Exceptional Case Team but should only be made where the patient demonstrates true clinical exceptionality. Individual Funding Requests-Mid Essex CCG always allows patients the opportunity to make specific funding requests via its Exceptional Case Team. Requests may include patients with conditions for which the CCG does not have an agreed policy, including patients with rare conditions and whose proposed treatment is outside agreed service agreements. Such requests should not constitute a request for a service development. The responsibility for adherence to these policies lies with the treating clinician and failure to adhere to these criteria may result in non-payment of the activity. All patients being referred for non-urgent elective surgery and who are smokers should be referred to smoking cessation services at the initial assessment appointment. There is strong clinical evidence that obese patients undergoing surgery are at significantly higher risk of getting infections and suffering heart, kidney and lung problems than people who are a healthy weight. They are also likely to have to spend more time in hospital recovering and their risk of dying as a result of surgery is higher compared to patients with a normal weight. Overweight patients should be strongly encouraged to lose weight before their operation and consider delaying referral for non-urgent elective surgery. *includes treatments, interventions and procedures 2 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Index A Abdominoplasty/Apronectomy Acne Vulgaris Aesthetic Facial Surgery Autologous Cartilage Transplantation H B Bariatric surgery and access to specialist obesity services Benign Skin lesions Blepharoplasty Bobath Therapy Bone anchored hearing aid Breast Asymmetry Breast Augmentation/ Implants Breast reduction Bunions I C D Capsule Endoscopy and Double Balloon Enteroscopy Carpal Tunnel Cataracts Chalazia Chronic Fatigue Syndrome Circumcision Cochlear Implants Complementary and alternative therapies Continuous Glucose Monitoring Continuous Positive Airways Pressure (CPAP) Dental Procedures (orthodontics) Dilatation and curettage / hysteroscopy Dupuytren's Contracture Dysthyroid eye disease Drugs-see Medicines Management-CCG K L M N O Hernia (surgical treatment) Hip Arthroscopy Hip Injections Hip Replacement Hip Resurfacing Hirsutism Hair Depilation Hysterectomy IngrownToeNail Interventional Procedure Guidance-policy statement IVF (assisted conception) Knee Arthroscopy Knee replacement Labial Reduction-Refashioning Liposuction Lymphoedema MRI (See Open MRI) Nasal Surgery (Rhinoplasty and Septorhinoplasty) Nipple Inversion Open MRI Orthoses P Penile implants Pinnaplasty/ Otoplasty R Repair of ear lobes Reversal of sterilisation Rhinophyma S Sacroneuromodulation Scar revision Shoulder arthroscopy Skin contouring Sleep Studies/Snoring Snoring Sperm, Embryo or Oocyte storage Spinal Cord Stimulation Spinal Injections Spinal surgery for non-acute lumbar conditions Surrogacy Tattoo removal Temporomandibular joint replacement Temperomandibular Joint Retainers and Appliances Tinnitus Tonsillectomy Toric Lens implants Trigger Finger E Exogen Bone Healing Ultrasound Systems F Face lifts and brow lifts (Rhytidectomy) Facet Joint Injections and Medial Branch Blocks Female Sterilisation Fibroid embolization and Uterine Artery Embolisation Functional Electrical Stimulation (FES) T G Ganglion Gastroelectrical Stimulation (GES) Gender Dysphoria Grommets Gynaecomastia V Varicose veins Vasectomies W Wigs, Hairpieces and Hair Transplant/Replacement Systems 3 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Abdominoplasty or Apronectomy Status: Individual Prior Approval MECCG commissions abdominoplasty and apronectomy on a restricted basis in patients who meet the following criteria: A Where it is required as part of abdominal hernia correction or other abdominal wall surgery OR B Those patients from the following groups who have significant abdominal aprons as a result of weight loss and the flap (panniculus) hangs at or below the level of the symphysis pubis and have severe functional problems*: Patients with excessive abdominal folds who had an initial BMI >40 and have achieved a reduction in BMI < 25 and have maintained the BMI < 25 for at least 2 years OR Patient with excessive abdominal folds who have an initial BMI > 50 and have achieved a minimum drop of 20 BMI points and have maintained this BMI (reduction of a minimum of 20 points) for at least 2 years. *Severe functional problems include: Chronic and persistent skin condition (for example, intertriginous dermatitis, cellulitis or skin ulcerations) that is refractory to at least six months of medical treatment. In addition to good hygiene practices, treatment should include topical antifungals, topical and/or systemic corticosteroids and/or local or systemic antibiotics Abdominal wall prolapse with proven urinary symptoms Problems associated with poorly fitting stoma bag Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 4 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Bariatric Surgery and access to specialist obesity services Status: Individual Prior Approval Essex County Council is responsible for commissioning Tier 2 services and currently commissions courses for overweight or obese patients with a BMI over 25kg/m2 or 23kg/m2 for those from African-Caribbean or Asian [South Asian and Chinese] populations GP or patient self-referral contact current provider-ACE Weight Management Service (‘My Weight Matters’) on 0800 022 4524 then option 3. MECCG does not commission specialist multidisciplinary obesity services (Tier 3) Individual prior approval Patients will be considered for referral to tertiary services (assessment for bariatric surgery) if they meet the following criteria: Patient is 18 year or older. Patient has BMI > 35 for at least 5 years with significant co-morbidities (for example type 2 diabetes, hypertension, cardiovascular disease, osteoarthritis, dyslipidaemia and sleep apnoea), OR Patients with BMI > 40 for at least 5 years without co-morbidities Patient provides evidence of attendance, engagement and full participation in a weight management programme. Engagement can be judged by attendance records and achievement of pre-set individualised targets (for example steady and sustained weight loss of 5-10%, or maintaining constant weight whilst stopping smoking). Patient has completed a Tier 2 weight management course within the last 12 months.Examples of Tier 2 courses would include My Weight Matters (delivered by ACE), Slimming World and Weight Watchers, although others are available. Such a programme should be in the spirit of a lifestyle weight management service as described by NICE (“Managing overweight and obesity in adults”, NICE Public Health Guidance 53, May 2014):o Are multi-component, e.g. consider diet, physical activity levels and behaviour change; o Focus on life-long lifestyle change; o Last at least 3 months, and that sessions are offered at least weekly or fortnightly and include a 'weigh-in' at each session; o Ensure specific dietary targets are agreed and progress monitored; o Ensure discussions take place about how to reduce sedentary behaviour and the type of physical activities that can easily be integrated into everyday life and maintained in the long term; 5 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED o Use a variety of behaviour-change methods, e.g. how to make changes to the social environment; self-monitoring of weight and behaviours that can affect weight. AND Patient has completed a Tier 3 weight management programme or has kept a 12 month (minimum) diary recording physical exercise undertaken, diet consumed and weight progress which has been reviewed and signed by a registered healthcare professional at least once every 3 months. The healthcare professional should keep a record of their discussion with the patient re progress. Patients who partially complete a Tier 3 management programme may count time spent within Tier 3 towards this 12 month minimum requirement. Patient is a non-smoker at the time of referral (as confirmed by CO monitor) and maintains this status. GP has addressed and optimised management of any underlying social circumstances or clinical conditions which may be affecting weight management in the patient e.g. hormone problems such as underactive thyroid, Cushing's syndrome, polycystic ovarian syndrome (PCOS); substance misuse o lack of sleep- exclude obstructive sleep apnoea-Epworth score of 10 or less o depression- patients with a score of more than 17 on PHQ9 screening tool must be referred to IAPT and condition managed before referral o alcohol consumption-refer to http://openroad.org.uk/contact_us/ and condition managed before referral o social circumstances- refer to appropriate service through Essex Connects (social prescribing project) http://www.nice.org.uk/guidance/PH53 Funding for patients to be referred for assessment not meeting the above criteria will only be granted in clinically exceptional circumstances. Patients will only be considered for surgery if the patient fulfils the criteria for treatment as per the NHS England’s Clinical Commissioning Policy: Complex & Specialised Obesity Surgery, www.england.nhs.uk/wp-)content/uploads/2013/04/a05-p-a.pdf) released April 2013. Please note: The NHS England complex obesity surgery policy states that bariatric surgery should not be commissioned for children under 18 years. Such cases would be reviewed on an exceptional treatment case basis by the local CCG. Ref: http://www.nice.org.uk/guidance/PH53 https://www.nice.org.uk/guidance/cg189/resources/guidance-obesity-identificationassessment-and-management-of-overweight-and-obesity-in-children-young-people-andadults-pdf 6 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Benign Skin Lesions/Conditions Status: Threshold and Individual Prior Approval MECCG does not commission surgical removal, laser treatment or cryotherapy of clinically benign skin lesions/conditions for purely cosmetic reasons. Surgery or treatments to improve appearance alone is not provided for normal changes such as those due to ageing. The fact that a patient wants to have a lesion removed does not constitute a sound reason for doing so at NHS expense. MECCG commissions the removal of benign skin lesions on a restricted basis only. This restriction applies to referrals to secondary care dermatology/plastic surgery services commissioned by the CCG. GPs should not refer patients who do not meet the criteria detailed below. Referrals to CCG commissioned community based dermatology or minor surgery clinics must meet the criteria laid down in the service specification. Providers will not be funded where patients are treated outside the commissioned service. This policy does not apply to minor surgery undertaken in primary care which is outside the remit of this policy as it falls under the commissioning responsibility of NHS England. GPs providing Minor Surgery as an Additional Service (curettage and cautery and, in relation to warts, verrucae and other skin lesions e.g. seborrhoeic keratosis, cryocautery) or Minor Surgery as a Directed Enhanced Service (DES) under GMS/PMS contracts must adhere to the restrictions as detailed within those service specifications. GPs should note that removal of benign skin lesions for purely cosmetic reasons will not be funded by NHS England under this DES. All suspected malignant lesions are excluded from this policy – these should be managed via the 2 week wait with the exception of Basal Cell Carcinoma (BCC), where low risk BCC may be removed in the community in line with NICE recommendations and high risk BCC should be referred through the usual pathway. Once it is established that a skin lesion is not malignant its removal will not normally be funded by the NHS though a clinician may request exceptional funding. Clinicians referring on this basis should make the patient explicitly aware that removal of the lesion may not occur. The list below gives examples of lesions included in this policy. This list is not exhaustive. Benign pigmented naevi (moles) Seborrhoeic keratoses (benign skin growths, basal cell papillomas) Comedones Skin tags including anal tags Dermatofibromas (skin growths) Spider naevus (telangiectasia) Lipomas Thread veins Milia Warts and plantar warts Molluscum contagiosum Xanthelasma (cholesterol deposits Sebaceous cysts (epidermoid and pilar cysts) underneath the skin), Port wine stains Neurofibromata Post acne scarring Individual prior approval must be obtained before referral except where a patient meets criteria A below. 7 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED A. Threshold Approval If a benign skin lesion of the eye obscures vision or is causing a separate ocular problem then the patient can be referred to an ophthalmologist for removal B. Individual Prior Approval Requests for the removal of benign skin lesions will be considered where one or more of the following apply: There is confirmed, evidenced history of recurrent infection requiring regular courses of antibiotics. There is significant pain as a direct result of the lesion requiring regular prescribed strong analgesics. Lesions are rapidly growing or abnormally located (e.g. sub-fascial, sub-muscular). Lesions cause functional impairment which prevents the individual from fulfilling work/study/carer or domestic responsibilities Lesions are on the face where the extent, location and size of the lesion can be regarded as considerable disfigurement, and which sets them apart from the cohort of people with lesions. There is clinical evidence that a commonly benign or non-aggressive lesion may be changing to a malignancy, or there is sufficient doubt over the diagnosis to warrant removal. Evidence that previous treatment has been pursued before requesting approval to refer will be required. For those requiring prior approval this evidence must be provided with the request for funding. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. Ref: Greater Manchester EUR Policy Statement Common Benign Skin Lesion November 2014 Reference: GM013 http://northwestcsu.nhs.uk/BrickwallResource/GetResource/587b2fcf-ac0b-4b8c-ae8e3f900d9649d1 8 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Blepharoplasty Status: Individual Prior Approval MECCG commissions blepharoplasty on a restricted basis in patients who meet the following criteria: Upper Lid This procedure will be funded to correct visual functional impairment (not purely for cosmetic reasons). Indications: Impairment of visual fields in the relaxed, non-compensated state. Evidence will be required that eyelids impinge on visual fields reducing field to 120° laterally and 40° vertically (to be confirmed by visual fields test). Lower Lid This will be funded for correction of ectropion or entropian or for the removal of lesions of the eyelid skin or lid margin which impair function. Individual prior approval for funding is required. Also see related policy Dysthyroid eye disease. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 9 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Breast Augmentation/Implants Status: Threshold/Individual Prior Approval MECCG does not commission plastic surgery for purely cosmetic reasons. Funding for surgery or treatments to improve appearance alone is not provided. Breast augmentation Breast augmentation is routinely funded for the following indication: reconstructive following or as part of surgery for breast malignancy or its prevention as defined in the commissioned pathway (threshold approval) congenital amastia (complete absence of breast tissue)-individual prior approval Individual Prior Approval Removal and replacement of breast implants: MECCG only commissions the removal/replacement of breast implants in the following circumstances as detailed: Breast implants were originally funded by the NHS (e.g. as part of treatment for breast cancer), and the implant(s) need to be removed/replaced for clinical reasons, such as implant rupture, infection or capsular contraction OR The implant(s) were privately funded and need to be removed for clinical reasons, such as implant rupture, infection or capsular contraction. Patients will be offered the choice of removing both prostheses in the event that only one has ruptured with the intention of preserving symmetry. The replacement of privately funded breast implants where removal is clinically required is not routinely commissioned. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 10 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Bunion (Hallux valgus) surgery Status: Individual Prior Approval MECCG commissions surgery for bunions on a restricted basis. Bunion surgery is justified and appropriate when: AND AND the patient experiences persistent pain and functional impairment that is interfering with the activities of daily living. all appropriate conservative measures have been tried over a 6 month period and failed to relieve symptoms, including up to 12 weeks of evidence based non-surgical treatments, i.e. analgesics/painkillers/bunion pads, footwear modifications the patient understands that they will be out of sedentary work for 2-6 weeks and physical work for 2-3 months and they will be unable to drive for 6-8 weeks, (2 weeks if left side and driving automatic car) OR there is a higher risk of ulceration or other complications, forexample, neuropathy, for patients with diabetes. Such patients should be referred for an early assessment. A patient should not be referred for surgery for prophylactic or cosmetic reasons for asymptomatic bunions. Funding for patients not meeting the above criteria will only be made available in clinically exceptional circumstances. 11 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Capsule Endoscopy Double Balloon Enteroscopy Status: Individual Prior Approval MECCG commissions wireless capsule endoscopy and double balloon endoscopy on a restricted basis in the following circumstance Diagnostic - Wireless capsule endoscopy (WCE) and double balloon enteroscopy (DBE) in obscure gastrointestinal bleeding Criteria MECCG will fund wireless capsule endoscopy or double balloon enteroscopy for obscure gastrointestinal bleeding when: Patients with gastrointestinal bleeding have undergone a gastroscopy and/or endoscopy and results are negative then Capsule endoscopy for investigation A) If wireless capsule endoscopy identifies source of bleeding in small bowel then Where indicated, double balloon enteroscopy for treatment B) If results of wireless capsule endoscopy are normal but there is persistent bleeding then OR Consider second look wireless capsule endoscopy Double balloon enteroscopy for investigation and treatment where appropriate Rationale The evidence available shows that WCE and DBE are safe and effective diagnostic procedures for the detection of OGIB. Both have a higher diagnostic yield than conventional methods. WCE and DBE have common indications but different features. WCE can cover the whole GI tract, requires no sedation and is better tolerated by patients. Its major limitations are the inability to obtain a biopsy, precisely localise a lesion, or perform therapeutic endoscopy. DBE has the advantage of being controllable and enabling therapeutic treatment to take place simultaneously. The procedure is invasive and not as well tolerated as WCE, requiring additional staff, typically two physicians or an additional specialist nurse. Cost-effectiveness modelling suggests that that CE-guided DBE may be associated with better long-term outcomes because of the potential for fewer complications and decreased utilisation of endoscopic resources. 12 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Diagnostic - Wireless capsule endoscopy and double balloon enteroscopy in Crohn’s disease Criteria CCGs will fund wireless capsule endoscopy or double balloon enteroscopy for Crohn’s disease when: Following inconclusive ileocolonoscopy and/or small bowel radiology clinical suspicion of Crohn’s disease remains then: A) If pain is not a significant feature or where pain is a significant feature and there is no evidence of strictures on small bowel radiography. Wireless capsule endoscopy for diagnosis B) If pain is significant feature and there is evidence of strictures on small bowel radiography or wireless capsule endoscopy results are inconclusive. Double balloon enteroscopy to obtain histology Rationale The evidence available shows that WCE is a safe and effective diagnostic procedure for the detection of Crohn’s disease. WCE has a higher diagnostic yield than push enteroscopy and other conventional methods. The results suggest that it is superior to conventional radiological procedures in the detection of lesions in patients with Crohn's disease. However, the high number of patients with strictures limits its use as a first line diagnostic test in patients previously diagnosed. Capsule retention remains a risk in patients with Crohn’s disease with significant strictures. The risk is greater in patients with established Crohn’s disease compared to patients suspected to have Crohn’s disease. Evidence NICE produced interventional procedure guidance on WCE in 2004 Guidelines produced by British Society of Gastroenterologists in 2008, state DBE should be used complementary to WCE, particularly in the context of therapeutic intervention beyond the reach of push enteroscopy. References: 1. NICE. 2004. IPG 101. Wireless capsule endoscopy for investigation of the small bowel – guidance. 13 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Carpal Tunnel Status: Threshold Approval MECCG commissions surgery for carpal tunnel syndrome on a restricted basis. Nerve conduction studies are NOT generally needed to confirm the diagnosis. In elderly patients the condition may develop insidiously and nerve conduction studies may be useful to assess severity. Community based conservative treatment should be initiated for all patients with suspected Carpal Tunnel Syndrome for a period of 6 months, excluding those noted below. Conservative treatment will include the following: Analgesia Splinting with Futuro-type cock up splint (night time only or constant) Steroid injection – should be administered twice prior to referral for consideration of surgery. All GPs should seek access to carpal tunnel injections in the community. Patients with Carpal Tunnel Syndrome should be referred if any of the following apply: Severe symptoms (fewer than 5% of patients) uncontrolled by conservative measures, significantly interfering with daily activities. Neurological deficit i.e. constant sensory blunting or weakness of thenar abduction (wasting or weakness of abductor pollicis brevis). Unclear diagnosis or dual pathology Rheumatoid Recent trauma Previous surgery Where applicable, referral letter must detail conservative methods tried and the length of time that each of these was carried out. Uncomplicated cases who have NOT responded to conservative management for 6 months should be referred to community based service. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 14 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Cataracts Status: Threshold Approval MECCG commissions surgery for cataracts/lens extraction on a restricted basis. Referrals should not be based simply on the presence of a cataract. Cataract surgery should, therefore, not normally be offered to patients with a visual acuity better than 6/12 in the worst eye. This applies to both first and second eye surgery. Patients with the following symptoms or clinical conditions may benefit from cataract surgery when their visual acuity in the worse eye is 6/12 or worse. This list is not exhaustive: 1. 2. 3. 4. 5. 6. Patients experiencing significant glare and dazzle in daylight or difficulties with night vision when these symptoms are due to lens opacities. This indication applies particularly, but not exclusively to driving. Patients requiring particularly good vision for employment purposes. Difficulty with reading due to lens opacities. Significant optical imbalance (anisometropia or anisekonia) following cataract surgery on the first eye. Management of coexisting other eye conditions. Refractive error primarily due to cataract. Cataract surgery/lens extraction should not normally be performed solely for the purpose of correcting longstanding pre-existing myopia (short sighted or near sighted) or hypermetropia (long sightedness). The reasons why the patient’s vision and lifestyle are adversely affected by cataract and the likely benefit from surgery must be documented in the clinical records. All patients referred to be considered for cataract should, whenever possible, have completed the Patient Decision Aid on http://sdm.rightcare.nhs.uk/pda/. This is available on website, on paper and phone app. The referring optometrist or GP should discuss the risks and benefits using an approved information leaflet (national or locally agreed) and ensure that the patient understands and is willing to undergo surgery before referring. Second eye: As the benefits of second eye surgery have been demonstrated patients will be offered second eye surgery provided they fulfil the referral criteria. Second eye surgery should be deemed urgent when there is resultant anisometropia (a large refractive difference between the two eyes of 2 ½ dioptas) which would result in poor binocular vision or diplopia (this should be clearly recorded in the patient’s notes). The reasons why the patient’s vision and lifestyle are adversely affected by cataract and the likely benefit from surgery must be documented in the clinical records. Providers will be audited on the indications for cataract surgery. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 15 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Chalazia Status: Threshold Approval MECCG commissions surgery for chalazia on a restrictive basis. MECCG operates a community service for excision of chalazia when the patient presents with two or more of the following: Present for more than six months Present on the upper eyelid Interferes with vision Conservative management has been tried & failed and there is no appropriate alternative to surgical intervention. The site of the lesion or lashes renders the condition as requiring specialist intervention. Only the patients meeting the following criteria should be referred to secondary care: All children should be referred on. Any recurrent chalazion should be referred. Any atypical features i.e lash loss, bleeding should be referred. Any patient with previous history of Basal cell carcinoma (BCC) or Squamous cell carcinoma (SCC) should be referred on. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 16 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Circumcision Status: Threshold Approval MECCG commissions circumcision on a restricted basis. Circumcision should only be performed for the following indications: Phimosis (inability to retract the foreskin due to a narrow prepucial ring) in children when associated with recurrent infection. This does NOT include normal non-retractile foreskin of childhood. Adult phimosis, usually caused by recurrent balanitis or Balanitis Xerotica Obliterans (BXO) 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) There are several alternatives to treating retraction difficulties ( e.g. steroid creams) before circumcision is carried out. It is important that all those performing circumcision should follow the General Medical Council (GMC) guidelines Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 17 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Policy statement: Continuous Positive Airway Pressure (CPAP) in Adults Status: Threshold Approval MECCG commissions Continuous Positive Airway Pressure (CPAP) for patient with moderate or severe Obstructive Sleep Apnoea/Hypopnoea Syndrome (OSAHS) in Adults (≥15 hypopnoea events/hour per night) CPAP is the first choice therapy for patients with moderate or severe OSAHS that is sufficiently symptomatic to require intervention. Persistent low CPAP use (less than two hours per night) over six months, following efforts to improve patient comfort, should lead to a review of treatment. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 18 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Dilatation and Curettage/Hysteroscopy Status: Threshold Approval MECCG commissions Dilatation and Curettage/Hysteroscopy on a restricted basis. MECCG only funds D&C and hysteroscopy when used in line with NICE guidance (CG44, 2007) Funding for patients to undergo hysteroscopy will only be made available for the investigation and management of heavy menstrual bleeding when it is carried out: as an investigation for structural and histological abnormalities o where ultrasound and endometrial biopsy has been used as a first line diagnostic tool and o where the outcomes are inconclusive, for example to determine the exact location of a fibroid or the exact nature of the abnormality; where endometrial ablation is required hysteroscopy should be considered immediately prior to the ablative procedure to ensure correct placement of the device. Funding will not be made available for patients to receive D&C: as a diagnostic tool for heavy menstrual bleeding; or as a therapeutic treatment for heavy menstrual bleeding. Postmenopausal women who have had a pelvic scan and endometrial biopsy and who present with further bleeding 6 months later should be offered hysteroscopy to be sure no small cancer has been missed without a mandatory preliminary scan. Hysteroscopy for the majority of women can be performed as an outpatient procedure. NICE Heavy Menstrual Bleeding –Clinical Guideline January 2007 http://www.nice.org.uk/nicemedia/live/11002/30404/30404.pdf Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 19 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Dupuytren’s Contracture Status: Threshold Approval Surgical and specialist drug treatment for Dupuytren’s contracture is commissioned by MECCG on a restricted basis. Cases will only be funded if they meet the criteria below: Metacarpophalangeal joint (MCPJ) or Proximal IP joint contracture of 30° or more (inability to place hand flat on table) AND Where such condition (either MCPJ or PIPJ) is severely impacting on activity of daily living OR Young patients with early onset disease (25-40) +/- family history, who may benefit from early assessment The use of Collagenase clostridium histolyticum (Xiapex®) is not funded. Radiation therapy for early Dupuytren’s contracture is not funded. For audit purposes the referral letter should detail loss of extension and functional impairment. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. Ref: www.nice.org.uk/guidance/IPG43 www.nice.org.uk/guidance/IPG368 www.nice.org.uk/guidance/indevelopment/gid-tag364 20 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Dysthyroid eye disease Status: Individual Prior Approval MECCG commissions surgery for proptosis on a restricted basis for which individual prior approval is required. Funding will be provided to treat proptosis, arising from thyroid disease, as a result of enlargement of muscles in the socket and increased fatty tissue or abnormality of position of eyelid which causes extra exposure to the eye surface. Surgery will only be offered for abnormality of the eyelid position after artificial tears have been tried for at least 6 months and failed Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 21 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Exogen® Bone healing ultrasound system Status: Individual Prior Approval MECCG commissions EXOGEN® ultrasound bone healing system for non-union in long bone fracture on a restricted basis. 1 The case for adopting the EXOGEN® ultrasound bone healing system to treat long bone fractures with non-union- i.e. failure to heal after 9 months but less than 12 months - is supported by the clinical evidence, which shows high rates of fracture healing. On this basis MECCG only funds EXOGEN® in the following circumstances: In patients with non-union fractures in long bones which have failed to heal after 9 months but less than 12 months. Patient age > 18 years Patient does not have unstable surgical fixation Bones are well aligned Inter-fragment gap is ≤ 10mm Patient is not pregnant Patient does not have a pacemaker, poor blood circulation or clotting problems Patient does not have fractures due to bone cancer or vertebral/skull fractures Patient has the ability to comply with usage protocol and criteria in line with the EXOGEN® International* Performance Program which includes a 90% minimum adherence to the treatment regimen MECCG does not commission the use of EXOGEN® in patients with delayed healing fractures that have no radiological evidence of healing after 3 months. MECCG does not commission the use of EXOGEN® for any other indications Patients not meeting these criteria will only be funded in exceptional clinical circumstances. NOTE: For treatment failures, providers will ensure that a reimbursement is obtained in accordance with the manufacturers “money back guarantee” arrangement; commissioners will not fund these patients. 1 NICE guidance Medical Technology Guidance 12 found at http://guidance.nice.org.uk/mtg12 22 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Ganglion Status: Threshold Approval Surgical removal of ganglion in secondary care is commissioned by MECCG on a restricted basis. Cases will only be funded if they meet the criteria below: Painful seed ganglia OR Mucoid cysts that are disturbing nail growth or have a tendency to discharge (risk of septic arthritis in distal inter-phalangeal joint) OR Neurological loss or weakness of the wrist OR Where the ganglion has resulted in functional impairment which prevents the individual from fulfilling work/study/carer or domestic responsibilities, but has not responded to all appropriate conservative1 treatments over a minimum period of 3 months. 1 Conservative treatments include: Reassurance – 35-45% of wrist ganglia resolve with no treatment at all. Aspiration – There is a significant recurrence rate after a single aspiration (using wide bore needle) but after 3 serial aspirations the recurrence rate is only 12-15% which is comparable with surgery There is no indication for the routine excision of simple ganglia; these should not generally be referred. For audit purposes, the referral letter and hospital records should include detail on: Precise location of ganglion e.g. flexor tendon Size in cm/inches (length and width) How function of the area is impaired? i.e. what is the patient unable to do as a result of the ganglion? Degree of pain How long it has existed plus dates of 3 serial aspirations Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 23 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Grommets Status: Threshold Approval/Individual Prior Approval MECCG commissions grommet insertion on a restricted basis. Threshold Approval Patients will be funded for grommet (ventilation tube) insertion if they meet the following criteria: Children with persistent bilateral OME documented over a period of 3 months with a hearing level in the better ear of 25–30 dBHL or worse averaged at 0.5, 1, 2 and 4 kHz (or equivalent dBA where dBHL not available) OR Children who have had at least 5 occurrences of acute otitis media in the last year with additional complications such as perforations, persistent discharge, febrile convulsions, sensor neural deafness or cochlear implantation. The persistence of bilateral OME and hearing loss needs to be confirmed over a period of 3 months before surgical intervention will be considered. The child’s hearing should be re-tested at the end of this time. During this active observation period of 3 months, advice on educational and behavioural strategies to minimise the effects of the hearing loss should be offered. Individual prior approval Patients will be considered for funding if they meet one of the following criteria- individual prior approval is required: Children with persistent bilateral OME with a hearing loss less than 25–30 dBHL where the impact of the hearing loss on a child’s developmental, social or educational status is judged to be significant. Adjuvant adenoidectomy will not be considered in the absence of persistent and/or frequent upper respiratory tract symptoms in the child. Children with Down’s Syndrome or cleft palate, as an alternative to hearing aids for treating persistent bilateral OME with hearing loss (and/or significant impact on child’s developmental, social or educational status) For children with Down’s syndrome, the following factors need to be considered before the intervention is offered: o o o o o the severity of hearing loss the age of the child the practicality of ventilation tube insertion the risks associated with ventilation tubes the likelihood of early extrusion of ventilation tubes Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 24 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Hernia (surgical treatment) Status: Threshold Approval MECCG commissions surgical treatment of hernias on a restrictive basis for patients meeting the defined criteria below. This policy covers the management of inguinal, femoral, umbilical, ventral and incisional hernias, with criteria for referrals/treatment. Inguinal: For asymptomatic or minimally symptomatic hernias, we advocate a watchful waiting approach, under informed consent. Surgical treatment should only be offered when one of the following criteria is met: Symptomatic i.e. symptoms are such that they interfere with work or activities of daily living OR The hernia is difficult or impossible to reduce, OR Inguino-scrotal hernia, OR The hernia increases in size month on month OR The patient is currently asymptomatic but works in a heavy manual occupation (for e.g. in removal firms lifting heavy weights) and there is an increased risk of strangulation and future complications. Femoral: All suspected femoral hernias should be referred to secondary care due to the increased risk of incarceration/strangulation Umbilical: Surgical treatment should only be offered when one of the following criteria is met: pain/discomfort interfering with Activities of Daily Living OR increase in size month on month OR to avoid incarceration or strangulation of bowel OR The patient is currently asymptomatic but works in a heavy manual occupation (for e.g. in removal firms lifting heavy weights) and there is an increased risk of strangulation and future complications Incisional Surgical treatment should only be offered when both of the following criteria are met: Pain/discomfort interfering with Activities of Daily Living AND Appropriate conservative management has been tried first e.g. weight reduction where appropriate OR The patient is currently asymptomatic but work in a heavy manual occupation (for e.g. in removal firms lifting heavy weights) and there is a risk of strangulation and future complications. Divarication of Recti: Diastases/Divarication of recti is a separation between the left and right side of the rectus abdominis muscle, and causes a protrusion in the midline, but is not a 'true' hernia and does not carry the risk of bowel becoming trapped within it and thus does not require repair. Evidence suggests that divarication does not carry the same risks as that of actual herniation. MECCG considers repair of divarication of recti as a cosmetic procedure and a low priority and as such does not routinely fund. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 25 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Status: Hip Arthroscopy- including surgery for FemoroAcetabular Impingement (FAI) Individual Prior Approval/Threshold Approval MECCG commissions hip arthroscopy on a restricted basis. Patients will be considered for funding if they meet the following criteria for the conditions listed. Individual Prior Approval Femoro-Acetabular Impingement (FAI) The CCG will fund open or arthroscopic hip surgery for the treatment of femoro-acetabular impingement (FAI) ONLY when patients fulfil ALL of the following criteria: Diagnosis of definite femoro-acetabular impingement defined by appropriate investigations, X-rays, MRI and CT scans. An orthopaedic surgeon who specialises in young adult hip surgery has made the diagnosis. This should include discussion of each case with a specialist musculoskeletal radiologist. Severe symptoms typical of FAI with duration of at least six months where diagnosis of FAI has been made as above. Failure to respond to all available conservative treatment options including activity modification, pharmacological intervention and specialist physiotherapy. Compromised function, which requires urgent treatment within a 6-8 months time frame, or where failure to treat early is likely to significantly compromise surgical options at a future date. Treatment with more established surgical procedures is not clinically viable. Exclusions for FAI MECCG will not fund hip arthroscopy in patients with femoro-acetabular impingement where any of the following criteria apply: • • • • • • Patients with advanced Osteo-Arthritic change on preoperative X-ray (Tonnis grade 2 or more) or severe cartilage injury (Outerbridge grade lll or lV). Patients with a joint space on plain radiograph of the pelvis that is less than 2mm wide anywhere along the sourcil. Patients who are a candidate for hip replacement. Any patient with severe hip dysplasia or with a Crowe grading classification of 4. Patients with generalised joint laxity expecially in diseases connected with hypermobility of the joints, such as Marfan syndrome and Ehlers-Danlos syndrome. Patients with osteogenesis imperfecta. Treatment of FAI should be restricted to centres experienced in treating this condition and staffed by surgeons adequately trained in techniques addressing FAI and all governance and audit undertaken in accordance with NICE IPG 403 and 408. 26 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Threshold Approval Sepsis of the hip joint Hip arthroscopy is supported in the washout of an infected hip joint in patients refractory to medical management, patients with underling disease or patients who are immunosuppressed. Loose bodies Hip arthroscopy is supported for the removal of radiologically proven loose bodies within the hip joint with an associated acute traumatic episode. Arthroscopy is not supported as a diagnostic tool where there is suspicion of loose bodies. Excision/repair of Radiological Proven Labral Tears in the Absence of OA or FemoroAcetabular Impingement Syndrome Hip arthroscopy is supported for the excision of radiological proven labral tears associated with an acute traumatic episode in the absence of OA or FAI syndrome. Funding for hip arthroscopy for all other circumstances will only be made available for clinically exceptional cases. NICE interventional procedure guidance 408 and 403 https://www.nice.org.uk/guidance/ipg408/resources/guidance-arthroscopic-femoroacetabularsurgery-for-hip-impingement-syndrome-pdf https://www.nice.org.uk/guidance/ipg403 27 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Hip Injections Status: Individual Prior Approval Current evidence on safety and efficacy does not appear adequate to routinely recommend hip injections. On this basis MECCG only funds Hip injection in the following circumstances: Diagnostic aid To introduce contrast medium to the joint as part of hip arthrogram Babies for hip arthrography Children and adults with inflammatory arthropathy Investigation of infection in biological and replaced hips. Individual prior approval is required. Funding outside the above circumstances will only be made available in clinically exceptional cases. 28 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Hip Replacement Status: Threshold Approval MECCG commissions surgery for hip replacement on a restricted basis. Referral should be when other pre-existing medical conditions have been optimised AND conservative measures have been exhausted and failed. MECCG will only fund hip joint replacement surgery if: The patient complains of severe joint pain AND has radiological features of severe disease AND has severe functional limitation irrespective of whether conservative management has been trialled, OR The patient complains of severe joint pain AND has radiological features of severe disease AND has minor to moderate functional limitation, despite the use of nonsurgical treatments such as adequate doses of NSAID analgesia, weight control treatments and physical therapies. OR The patient complains of mild to moderate joint pain AND has radiological features of severe disease AND has severe functional limitation, despite the use of non-surgical treatments such as adequate doses of NSAID analgesia, weight control treatments and physical therapies AND is assessed to be at low surgical risk. Prostheses for total hip replacement are recommended as a treatment option for people with end-stage arthritis of the hip only if the prostheses have rates (or projected rates) of revision of 5% or less at 10 years. Please refer to the classification of pain levels and functional limitations in the table on the next page. Referrals will not be accepted if the patient has an Oxford Hip Score greater than or equal to 20. This scoring should be completed in Primary Care prior to referral. The tool can be found at http://www.orthopaedicscore.com/scorepages/oxford_hip_score.html All patients referred to be considered for hip replacement should have completed the Patient Decision Aid on http://sdm.rightcare.nhs.uk/pda/. This is available on website, on paper and phone app. Patients who do not fulfil the above criteria may be considered where there are exceptional clinical circumstances Evidence suggests that the following patients would be INAPPROPRIATE candidates for hip joint replacement surgery: Where the patient complains of mild joint pain AND has minor or moderate functional limitation Where the patient complains of moderate to severe joint pain AND has minor functional limitation AND has not previously had an adequate trial of conservative management as described above Patients who are inappropriate for hip replacement surgery should not be listed for surgery. 29 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Hip replacement: Classification of Pain Levels and Functional Limitations Variable Pain Level Definition Mild Pain interferes minimally on an intermittent basis with usual daily activities. Not related to rest or sleep. Pain controlled by one or more of the following: NSAIDs with no or tolerable side effects, aspirin/paracetamol at regular doses. Moderate Pain occurs daily with movement and interferes with usual daily activities. Vigorous activities cannot be performed. Not related to rest or sleep. Pain controlled by one or more of the following: NSAIDs with no or tolerable side effects, aspirin/paracetamol at regular doses Severe Pain is constant and interferes with most activities of daily living. Pain at rest or interferes with sleep. Pain not controlled, even by narcotic analgesics. Previous non-surgical treatments Correctly Done NSAIDs, paracetamol, aspirin or narcotic analgesics at regular doses during 6 months with no pain relief; weight control treatment if overweight, physical therapies done. Incorrectly Done NSAIDs, paracetamol, aspirin or narcotic analgesics at inadequate doses or less than 6 months with no pain relief; or no weight control treatment if overweight or no physical therapies done. Functional Limitations Minor Functional capacity adequate to conduct normal activities and self care. Walking capacity of more than one hour. No aids needed. Moderate Functional capacity adequate to perform only a few or none of the normal activities and self care. Walking capacity of about one half hour. Aids such as a cane are needed. Severe Largely or wholly incapacitated. Walking capacity of less than half hour or unable to walk or bedridden. Aids such as a cane, a walker or a wheelchair are required. 30 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Hip resurfacing Status: Individual Prior Approval MECCG commissions hip resurfacing on a restricted basis. MECCG will only fund those patients who otherwise qualify for primary total hip replacement, but are likely to outlive conventional primary hip replacements as restricted by NICE Guidance Hip disease - metal on metal hip resurfacing (TA44). Hip resurfacing is not generally considered the best option for women over the age of 65. Clinicians applying for funding approval should provide full clinical rationale for choice. Prostheses for resurfacing arthroplasty are recommended as a treatment option for people with end-stage arthritis of the hip only if the prostheses have rates (or projected rates) of revision of 5% or less at 10 years. http://www.nice.org.uk/guidance/ta304/resources/guidance-total-hip-replacement-andresurfacing-arthroplasty-for-endstage-arthritis-of-the-hip-review-of-technology-appraisalguidance-2-and-44-pdf Issued: February 2014 31 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Hysterectomy for heavy menstrual bleeding Status: Threshold Approval Hysterectomy for heavy menstrual bleeding will only be funded by MECCG within NICE guidance and when There has been a trial, after appropriate clinical assessment, with a levonorgestrelreleasing intrauterine system LNG-IUS, e.g. Mirena®, unless contraindicated, for at least 6 cycles and this has not successfully relieved symptoms or has produced unacceptable side effects. AND At least one of another treatment has failed, is not appropriate or is contra-indicated in line with NICE guidelines2: • Alternative hormonal treatment in keeping with NICE guidance • NSAIDs and Tranexamic Acid For those who for ethical reasons cannot accept the use of Mirena®, they should have tried at least two of the alternative treatments. AND Either of the following are not clinically appropriate • Endometrial ablation if normal uterus or if LNG-IUS contraindicated or if ablation is contraindicated e. g. previous multiple caesarean section • Endometrial resection Contraindications to the levonorgestrel intrauterine system are: Distorted or small uterine cavity (with proven ultrasound measurements; Uterocervical canal length < 5cm) Genital malignancy Active trophoblastic disease Active pelvic inflammatory disease Large cavity over 10cm length Funding for hysterectomy outside the above criteria will only be funded in clinically exceptional circumstances. 32 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement : Status: Ingrown Toe Nails (surgery) Threshold Approval/Individual Prior Approval MECCG commissions surgery for ingrown toe nails on a restricted basis. Threshold Approval Referrals to commissioned community providers for nail surgery for ingrowing toenails will only be accepted for patients with moderate to severe symptoms where primary care management has failed Moderate-Severe Symptoms include: Increased pain and inflammation of the toe Purulent drainage Bleeding Recurrent Infection Severe and disabling pain Substantial erythema and inflammation Severe infection Chronic inflammation and granulation Nail fold hypertrophy Individual Prior Approval Surgery for ingrown toe nails is not routinely commissioned in a secondary care setting unless future orthopaedic surgery would be compromised- for example a recurrent infected ingrown toenail requiring treatment prior to joint replacement surgery. Individual prior approval must be sought. Funding for surgery for ingrown toenails for patients not meeting the above criteria will only be made available in clinically exceptional circumstances. 33 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Knee Arthroscopy Status: Threshold Approval Knee arthroscopy in secondary care is commissioned by MECCG on a restricted basis. Cases will only be funded if they meet the criteria below: Arthroscopy of the knee can be undertaken where a competent clinical examination (or MRI scan if there is diagnostic reason) has demonstrated clear evidence of an internal joint derangement (meniscal tear, ligament rupture or loose body) and where conservative treatment has failed or where it is clear that conservative treatment will not be effective. Knee arthroscopy can therefore be carried out for: Removal of loose body Meniscal repair or resection / repair of chondral defects Ligament reconstruction/repair (including lateral release) Synovectomy / symptomatic plica To assist selection of appropriate patients for uni-compartmental knee replacement Knee arthroscopy should NOT be carried out (and will not be funded) for any of the following indications: Investigation of knee pain (MRI is a less invasive alternative for the investigation of knee pain) Treatment of osteoarthritis including arthroscopic washout and debridement. In line with NICE guidance CG59; this should not be offered as part of treatment for osteoarthritis unless the individual has knee osteoarthritis with a clear history of mechanical locking (not gelling, ‘giving way’) Funding for knee arthroscopy outside the defined criteria will only be funded in clinically exceptional circumstances. 34 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy Statement: Knee Replacement Status: Threshold Approval MECCG commissions knee replacements on a restricted basis. Referral should only be made when other pre-existing medical conditions have been optimised AND conservative measures have been exhausted and failed. This will include weight reduction, NSAIDs and analgesics, changing activity, and introducing a walking aid. Please refer to the classification of pain levels and functional limitations in the table on the next page. MECCG will only fund knee replacements if: The patient complains of intense or severe symptomatology AND has radiological features of severe disease AND has demonstrated disease within all three compartments of the knee (tri-compartmental) or localised to one compartment plus patello-femoral disease (bi-compartmental). OR The patient complains of intense or severe symptomatology AND has radiological features of moderate disease AND is troubled by limited mobility or stability of the knee joint. Referrals will not be accepted if the patient has an Oxford Knee Score greater than or equal to 20. This scoring should be completed in Primary Care prior to referral. The tool can be found at http://www.orthopaedicscore.com/scorepages/oxford_knee_score.html All patients referred to be considered for a knee replacement should have completed the Patient Decision Aid on http://sdm.rightcare.nhs.uk/pda/. This is available on website, on paper and phone app. Patients who do not fulfil the above criteria may be considered where there are exceptional clinical circumstances 35 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Knee replacement: classification of pain levels and functional limitations Variable Pain Level Back to index Definition Mild Pain interferes minimally on an intermittent basis with usual daily activities. Not related to rest or sleep. Pain controlled by one or more of the following: NSAIDs with no or tolerable side effects, aspirin/paracetamol at regular doses Moderate Pain occurs daily with movement and interferes with usual daily activities. Vigorous activities cannot be performed. Not related to rest or sleep. Pain controlled by one or more of the following: NSAIDs with no or tolerable side effects, aspirin/paracetamol at regular doses Severe Pain is constant and interferes with most activities of daily living. Pain at rest or interferes with sleep. Pain not controlled, even by narcotic analgesics. Previous non-surgical treatments Correctly Done NSAIDs, paracetamol, aspirin or narcotic analgesics at regular doses during 6 months with no pain relief; weight control treatment if overweight, physical therapies done. Incorrectly Done NSAIDs, paracetamol, aspirin or narcotic analgesics at inadequate doses or less than 6 months with no pain relief; or no weight control treatment if overweight or no physical therapies done. Functional Limitations Minor Functional capacity adequate to conduct normal activities and self care. Walking capacity of more than one hour. No aids needed. Moderate Functional capacity adequate to perform only a few or none of the normal activities and self care. Walking capacity of about one half hour. Aids such as a cane are needed. Severe Largely or wholly incapacitated. Walking capacity of less than half hour or unable to walk or bedridden. Aids such as a cane, a walker or a wheelchair are required. 36 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Labial Reduction/Refashioning/Vaginoplasty/Cliteroplasty Status: Individual Prior Approval MECCG does not routinely commission elective vaginal labia reduction/refashioning or hymenorrhaphy or vaginoplasty or cliteroplasty as these are considered to be cosmetic procedures except • • vaginoplasty for congenital absence, significant developmental/endocrine abnormalities of the vaginal canal or post-traumatic vaginal stenosis reconstructive surgery for patients who have gone through female genital mutilation or cutting where individual funding requests will be considered. Repair of labia at the time of trauma will be routinely funded. Post immediate trauma applications will only be considered where there are clinically exceptional circumstances. Funding for patients outside this policy will only be granted in clinically exceptional circumstances N.B. NHS England is responsible for commissioning gender identity disorder services from Specialist Gender Identity Disorder Clinic Centres. This includes specialist assessment, nonsurgical care packages, transgender surgery and associated aftercare. . 37 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Lymphoedema Services Status: Threshold Approval MECCG commissions community based lymphoedema services. MECCG does not routinely commission intensive inpatient therapy or treatment in specialist units outside commissioned pathways. As lymphoedema is only one cause of oedema, the GP should ensure the correct diagnosis (remembering that most causes of peripheral oedema are cardiac, renal, hepatic or venous in origin, rather than lymphoedema) The oedema is persistent or greater than 3 months duration; or Patient is at known risk of lymphoedema. Patient must have tried and failed all available conservative management options before referral to a community based lymphoedema service. GPs must include evidence of meeting these requirements and confirm meets the criteria below before referral to a community based lymphoedema service. Patients who are restricted from having treatment for an unrelated condition that is usually available on the NHS and has the effect of increasing life-expectancy or quality life years as a direct result of the lymphoedema will be offered treatment. Funding for patients not meeting the above criteria will only be approved in clinically exceptional circumstances. 38 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Status: Nasal Surgery (including Rhinoplasty and Septorhinoplasty) Individual Prior Approval Nasal surgery to correct deformity and the cosmetic appearance of the nose, including Rhinoplasty and Septorhinoplasty, is not routinely funded by MECCG. Primary care must obtain prior approval before referring patients to secondary care providers and secondary care providers must satisfy themselves that the patient has funding secured prior to seeing the patient. This is to ensure inappropriate out-patient appointments are avoided and patient expectations are properly managed. NB: This policy does not apply to immediate post trauma nasal manipulation which normally occurs two to three weeks after the trauma and does not require prior approval from the Commissioner. Requests for corrective nasal surgery will be considered where the patient has: Post-traumatic nasal injury causing continuous and chronic nasal airway obstruction associated with septal/bony deviation of the nose which is causing significant functional impairment. Nasal deformity secondary to a cleft lip/palate or other congenital craniofacial deformity causing significant functional impairment Part of reconstructive head and neck surgery. OR OR MECCG will not approve funding for patients who are unhappy with the outcome of previous surgeries including immediate post-trauma corrections (whether provided by the NHS or private providers) or for snoring unless they meet the criteria above. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 39 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Nipple Inversion Status: Threshold approval MECCG commissions surgery to correct nipple inversions on a restricted basis. Nipple inversion may occur as a result of underlying breast malignancy. If the inversion is newly developed, it requires urgent referral and assessment. Surgical correction of nipple inversion is only funded for functional reasons i.e inability to feed their child in a post-pubertal woman and where the inversion has not been corrected by correct use of a non-invasive suction device. GPs who refer must ensure that patients comply with this criteria. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 40 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Open MRIs Status: Individual Prior Approval Referral for open MRIs in secondary care is commissioned by MECGG on a restricted basis. Cases will only be funded if they meet the criteria below: Open MRI scans will only be funded for morbidly obese patients unable to access local MRI services because of their size. Patients with claustrophobia are not eligible for open MRI scans. Funding outside this criterion will only be provided in clinically exceptional circumstances. 41 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Orthoses Status: Threshold Approval MECCG commissions orthoses on a restricted basis. MECCG does not routinely fund assessment for and/or orthoses (custom; off-the shelf; ‘inshoe’ appliances) except for conditions listed below. Referrals for assessment for orthoses will only be accepted for the following conditions. 1. Neurodisability 2. Talipes equinovarus 3. Adolescent tendinopathy at risk of developmental compromise 4. Post operative patients 5. Congenital skeletal abnormality 6. Burns MECCG only funds customised orthoses for these listed conditions where the clinical need of a patient cannot be met using an ‘off-the-shelf’ orthoses. Patients with structural/flexible flat foot requiring arch supports/pronation control orthoses should not be referred but advised to purchase ‘off-the-shelf’ /’in-shoe’ orthoses if required. Patients who have been funded for ‘off-the-shelf’ /’in-shoe’ orthoses by MECCG in the past will no longer be funded on this basis alone. Cervical Soft Collars MECCG does not routinely commission cervical soft collars. Lumbar Supports MECCG does not routinely commission lumbar support orthoses other than custom moulded back braces when prescribed following consultation with NHS commissioned spinal specialist surgeons. Funding outside these criteria will only be provided in clinically exceptional circumstances. 42 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Penile Implants Status: Threshold Approval MECCG will only fund penile implants for post-cancer reconstruction. Funding outside this criterion will only be provided in clinically exceptional circumstances. 43 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Pinnaplasty/Otoplasty Status: Individual Prior Approval MECCG commissions Pinnaplasty/Otoplasty surgery on a restricted basis. Cases will only be funded if they meet the criteria below: Patients may be eligible for surgery to correct prominent ears if both of the following criteria are met: Patient is aged between 10 and 16 years old AND With very significant ear deformity or asymmetry- All applications for funding must be accompanied by photographs Funding outside these criteria will only be provided in clinically exceptional circumstances. 44 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Repair of Ear Lobes Status: Threshold Approval MECCG commissions surgical repair of ear lobes on a restricted basis. This will be routinely funded for primary suture post trauma at the time of trauma only. e.g. the patient is automatically eligible for emergency treatment when he/she presents for repair at A&E at the time of trauma. Post immediate trauma applications will only be considered where there are clinically exceptional circumstances. 45 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement Reversal of Sterilisation Status: Individual Prior Approval MECCG commissions reversal of sterilisation on a restricted basis. Funding will only be considered if death of an existing child of the man has occurred, OR remarriage following death of spouse, OR loss of unborn child when vasectomy had taken place during the pregnancy. Funding will only be considered if death of an existing child of the woman has occurred, OR remarriage following death of spouse AND partner has a satisfactory sperm count. Patients should be aware that even if a successful reversal of sterilisation has taken place, they will not be eligible for IVF treatment. Funding outside these criteria will only be provided in clinically exceptional circumstances. 46 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Scar Revision Status: Individual Prior Approval MECCG commissions surgery for scar revision on a restricted basis. Funding for surgery for revision of scars will only be considered where the scar interferes with function. GPs should not refer unless the above criterion applies and referrals must include objective information to demonstrate this. Photographs will be required to support any application for funding Funding will only be made outside this criterion available where there are exceptional clinical circumstances. 47 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Shoulder Arthroscopy Status: Threshold approval MECCG commissions shoulder arthroscopy on a restricted basis. Shoulder arthroscopy will only be funded for patients with adhesive capsulitis (‘frozen shoulder’) if the following treatments have all been tried and failed: (a) (b) (c) (d) (e) Activity modification Physiotherapy and exercise programme Oral analgesics including NSAIDs (unless contraindicated) Intra-articular steroid injections Manipulation under anaesthetic GPs should not refer unless all the above have been tried and failed, and referrals must include objective information to demonstrate this. Providers should be aware that payment may be withheld if they cannot demonstrate that patients meet these criteria. Funding will only be made outside this criterion available where there are exceptional clinical circumstances. 48 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Sleep Studies including Diagnostic Investigations and Treatments for Obstructive Sleep Apnoea/Hypopnoea Syndrome (OSAHS) in Adults Status: Threshold Approval MECCG commissions sleep studies for adults (over 18 years of age) with suspected sleep apnoea, complex sleep disorders or where necessary to confirm a diagnosis of narcolepsy. NHS England commissions sleep studies for children and young people from Specialist Paediatric Respiratory Centres. http://www.england.nhs.uk/wp-content/uploads/2014/01/pssmanual.pdf Oral Appliances/Mandibular Advancement Devices Oral appliances have been shown to improve OSAHS and, in comparison with continuous positive airway pressure (CPAP), no conclusive difference in daytime sleepiness was shown. There are large cost, convenience and adherence implications for the use of CPAP and, for some patients, oral appliances may be of benefit. Therefore, oral applications (self-funded) should be promoted in primary care to avoid where possible the need for CPAP. Driving It is the responsibility of people who are sleepy during the day (regardless of the cause) to cease driving until their symptoms resolve. If the symptoms are severe enough to affect driving performance and are due or very likely due to a medical condition (including OSAHS) the driver must inform the DVLA. Although clinicians are not required to inform the DVLA about the patient’s symptoms, they are responsible for advising the patient appropriately. Vocational drivers of Heavy Goods Vehicles (HGVs) or Public Service Vehicles (PSVs) meeting the referral criteria of this policy may be referred for investigation with oximetry/polysomnography without attempted lifestyle modification and, if diagnosed with OSAHS at any level of severity may be offered oral devices or CPAP as initial options. For vocational drivers, if a diagnosis of OSAHS has been made or is strongly suspected adequate symptom control should be confirmed by a specialist before driving resumes and annual licensing review is required Limited Sleep Studies MECCG commissions limited sleep studies (pulse oximetry) for patients with suspected sleep apnoea where other causes of day time sleepiness have been excluded e.g. insufficient sleep, psychological conditions and sedating drugs. If obstructive sleep apnoea is suspected the patient should have attempted lifestyle modification i.e. weight loss, stop smoking, reduce alcohol consumption- as appropriate before referral. The following criteria must be met prior to referral for limited sleep studies: Patient ≥ 18 Patient snores Daytime sleepiness (rather than tiredness) assessed by Epworth scale with score ≥11 AND one or more of the following • Witnessed regular or frequent nocturnal apnoeic episodes of stopping breathing • Waking with sensations of choking/obstruction • Neck circumference ≥17ins in a man or > 15ins in a woman • Significant retrognathia • Small oedematous pharynx on visual inspection 49 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Polysomnograpy Patient has ≥5 <15 hyponea events/hour per night measured by pulse oximetry OR Patients who have typical symptoms of excessive daytime somnolence but no objective evidence of obstructive sleep apnoea on limited sleep study. OR Patient has suspected narcolepsy and confirmation of diagnosis Is required. MECCG does not commission surgical procedures for OSAHS. MECCG does not commission sleep studies for parasomnia, periodic limb movement disorder, chronic insomnia or snoring. MECCG does not routinely commission procedures for snoring where this is the sole problem- Snoring Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. Ref: http://www.sign.ac.uk/pdf/sign73.pdf 50 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Sperm, Embryo or Oocyte Cryostorage Status: Individual Prior Approval MECCG commissions Sperm, Embryo or Oocyte Cryostorage on a restricted basis. Funding for fertility preservation will be offered to patients who have a disease or a condition requiring medical or surgical treatment that has a significant likelihood of making them infertile. The following fertility preservation methods will be considered for funding: Sperm cryostorage Embryo cryostorage Oocyte cryostorage Patients must meet the following criteria: Commenced puberty and be aged up to 41 years old for women or up to 55 years old for men. Women not only need to be well enough to undergo ovarian stimulation and egg collection but this should not worsen their condition and that sufficient time is available prior to starting treatment. No Living or Adopted Children - From either current or any previous relationships. The adoption of children confers the legal status of parent to the adoptive parents; this will apply to both adoptions in and out of the family. Embryo or oocycte cryostorage will not be available where a woman: chooses to undergo medical or surgical treatment whose primary purpose is that it will render her infertile, such as sterilisation requests cryostorage for personal lifestyle reasons, such as wishing to delay trying to conceive. The sperm, embryos or oocytes will be stored for an initial period of 10 years. It is possible to extend the time of storage, if the material has not been used. This will require additional approval from MECCG. Funding for use of stored material for assisted conception is considered to be low priority by MECCG and is not routinely funded. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. It should be noted that the CCG is not the responsible commissioner for Pre-i mplantation Genetic Diagnosis and associated IVF/ICSI. This service is commissioned by NHS England Specialist fertility services for members of the Armed Forces are commissioned separately by NHS England 51 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Spinal cord stimulation Status: Individual Prior Approval MECCG commissions spinal cord stimulation in accordance with NICE TA 159. Spinal cord stimulation is recommended as a possible treatment for adults with chronic pain of neuropathic origin if they: continue to experience chronic pain (measuring at least 50 mm on a 0–100 mm visual analogue scale) for at least 6 months despite standard treatments, and have had a successful trial of spinal cord stimulation as part of an assessment by a specialist team Treatment with spinal cord stimulation should only be given after the person has been assessed by a specialist team experienced in assessing and managing people receiving treatment with spinal cord stimulation. MECCG will not routinely fund high frequency stimulators. Re-chargeable batteries for implantable pulse generators will be funded where this avoids the need for further surgery. It is expected that where there are different systems of equal effectiveness, the least costly system is used MECCG does not commission Spinal cord stimulation as a treatment option for adults with chronic pain of ischaemic origin Funding for patients not meeting the above criteria will only be funded in clinically exceptional circumstances. Ref: Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin NICE technology appraisal guidance [TA159] Published date: October 2008 https://www.nice.org.uk/guidance/ta159 52 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Spinal Injections (Therapeutic) for Pain Related to the Lumbar Spine Status: Threshold Approval NB. This policy addresses therapeutic use of spinal injections. It does not address diagnostic indications. (1) Any spinal therapeutic injection for patients with chronic pain1 Injections of therapeutic substances for pain related to the lumbar spine are not routinely commissioned for patients with chronic non-specific back pain. MECCG routinely commissions spinal therapeutic injections for chronic radicular pain only where recommended as part of a specialist multidisciplinary pain clinic management plan AND A programme of conservative management* has been unsuccessful or is not possible due to coexisting physical or mental illness or frailty. *Conservative management must include the following from a NHS commissioned service: advice and information on back pain management; group or customized exercise programme and where appropriate (according to specialist reassessment) manual therapy or hydrotherapy. On referral to the specialist multidisciplinary pain clinic, patients must be informed that the referral is for assessment and development of a pain management plan. Patients should not be under the impression that the decision to provide an injection has already been made or that repeat injections are routinely available. (2) Therapeutic epidural injections, sacroiliac injections and nerve root blocks in patients with acute episodes of pain (including acute on chronic) Commissioning of single injections is restricted to the following indications: The patient needs urgent relief of severe acute spinal pain. OR A specialist pain clinician judges that a single injection is necessary and appropriate to enable participation in a conservative pain management programme. OR The patient is unable to participate effectively in conservative pain management due to coexisting physical or mental illness or frailty. Repeat injections should not be routinely provided as there is a lack of high quality supporting evidence for long term pain relief and clinical advice suggests diminishing returns with increased risk of adverse events contd 53 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Repeat injections are commissioned only: If a specialist pain clinician taking account of multi-disciplinary team assessment, concludes that benefits outweigh harms: AND The patient has been clinically assessed as having had a substantial and sustained benefit from their first injection; AND The patient has been assessed as continuing to be unable to benefit from conservative management; AND Up to a maximum of 3 injections in 6 months. On referral to the specialist multidisciplinary pain clinic, patients must be informed that the referral is for assessment and development of a pain management plan. Patients should not be under the impression that the decision to provide an injection has already been made or that repeat injections are routinely available. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 54 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Spinal Surgery for Non-Acute Lumbar Conditions Status: Individual Prior Approval Recent changes in who commissions which aspects of back surgery are outlined below The NHS England commissions: All spinal deformity surgery (adults and children) All spinal reconstruction surgery (adults and children) Palliative or curative spinal oncology surgery (adults and children) Revision surgery for which the primary surgery is specialist, for example, revision surgery with instrumentation for over 2 levels All primary thoracic and primary anterior lumbar surgery Posterior cervical decompression surgery using instrumentation Cervical corpectomy CCGs may commission: revision surgery for which the primary surgery is non-specialist, i.e. revision surgery with instrumentation for 2 levels or under posterior cervical decompression surgery without instrumentation anterior cervical decompression surgery (discectomy or fusion) all spinal injections primary lumbar decompression/discectomy posterior lumbar un-instrumented fusions lumbar instrumented fusion for 2 levels or less revision, instrumented lumbar fusion for 2 levels or less MECCG only commissions spinal surgery for non-acute lumbar conditions on a restricted basis. Funding for patients to receive non-acute+ spinal surgery will only be made available under the following circumstance: Surgical discectomy (standard or microdiscectomy) in selected patients with sciatica secondary to disc prolapse where conservative management for at least 4-6 weeks has failed. NHS England does not routinely fund spinal surgery for lower back pain. Mid Essex Clinical Commissioning Group does not accept requests to fund spinal surgery for lower back pain. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. +Acute conditions include back pain due to fracture, dislocation, complications of tumour or infection and/or nerve root or spinal compression responsible for progressive neurological deficit. 55 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back toto index Back index Policy statement: Tinnitus Status: Threshold Approval MECCG provides funding for investigation of tinnitus on a restricted basis. Investigation is funded if the patient has: Consistent bilateral tinnitus (persistent for over 20 weeks) and hearing loss. Unilateral tinnitus (persistent over 2 months) Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 56 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Tonsillectomy Status: Threshold Approval MECCG commissions tonsillectomy on a restrictive basis for those patients who meet the SIGN Guidance 117 (April 2010) http://www.sign.ac.uk/pdf/sign117.pdf or one of the conditions listed below. A period of 6 months watchful waiting by the GP is recommended prior to tonsillectomy to establish firmly the pattern of symptoms and allow the patient to consider fully the implications of operation. Patients should meet all of the following criteria: AND AND Sore throats that are due to acute tonsillitis Episodes of sore throat that are disabling and prevent normal functioning Seven or more well documented, clinically significant, adequately treated sore throats in the preceding year. OR Five or more such episodes in each of the preceding two years. Three or more such episodes in each of the preceding three years. OR OR the patient should have one of the following conditions: intractable cough with a high level of streptococcal antibody for longer than one year; severe halitosis which has been demonstrated to be due to tonsil crypt debris for longer than one year. (diagnosed by an ENT surgeons) lymphoma and Ca tonsil, obstructive sleep apnoea, peritonsillar abscess not responding to antibiotics and incisional drainage. GPs should not refer unless the above criteria have been met, and referrals must include objective information to demonstrate this. Once a decision is made for tonsillectomy, this should be performed as soon as possible, to maximise the period of benefit before natural resolution of symptoms might occur (without tonsillectomy). Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 57 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Trigger Finger Status: Threshold Approval Referral for trigger finger in secondary care is commissioned by MECCG on a restricted basis. Cases will only be funded if they meet the criteria below: Patients who fail to respond to all appropriate conservative1 treatments for a minimum of 6 months. Conservative1 treatments include: Reassurance – up to 83% have been found to resolve spontaneously after a few months. Steroid injection – 50-80% will resolve after a single injection and a second injection should be carried out after 6 weeks if no response to first injection. OR Patients who have a fixed flexion deformity that cannot be corrected and that is severely impacting on activity of daily living OR Patients who have recurrent triggering after 2 injections For audit purposes, the referral letter and hospital records must include evidence that the patient meets the criteria, including the dates of the corticosteroid injections and any other conservative management. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. 58 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Varicose Veins Status: Threshold Approval Treatments for varicose veins are considered as procedures of low clinical priority and therefore not routinely funded by the Commissioner. Conservative management is the first line of treatment and applications will not normally be accepted without evidence that conservative management of asymptomatic and symptomatic varicose veins has been tried, and failed, for a period of at least six months. Prior to consideration for intervention patients should be given information regarding Weight loss if they have a raised BMI Light to moderate physical activity Avoiding factors which are known to make their symptoms worse, if possible Use of compression stockings for a 6 month duration, where this is considered appropriate When and where to seek further medial help MECCG commissions treatment or surgery for varicose veins on a restrictive basis. Funding for treatment or surgery will only be made available for Grade III and above Varicose Veins. Grade III: Varicose veins with complications, including bleeding, recurrent phlebitis or eczema. Patients who have had bleeding associated with varicose veins should be referred urgently. Patients with recurrent thrombophlebitis and persistent varicose veins may be referred, especially if phlebitis has affected veins above the knee. Patients with eczema near the ankle or associated with varicose veins below the knee should be referred for specialist advice. VARICOSE ECZEMA STASIS GRAVITATIONAL ECZEMA Interventional treatment should be in line with NICE guidance which identifies endothermal ablation as the first line intervention where suitable. Funding for patients not meeting the above criteria will only be granted in clinically exceptional circumstances. In drafting this policy it was noted that NICE CG 168 recommends that all symptomatic varicose veins should be referred for investigation and, where appropriate, treatment. Current resources cannot meet the demand that this would generate either in commissioning costs or in the capacity to undertake Doppler examinations etc. This policy is intended as a holding position until resources are available and the required pathway and contracting changes have been made to enable full adoption of NICE CG 168. http://www.nice.org.uk/guidance/CG168/chapter/introduction 59 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Policy statement: Wigs, Hairpieces and Hair Transplant/Replacement Systems Threshold Approval MECCG commissions hair pieces and wigs for patients experiencing total or severe hair loss as a result of alopecia totalis, cancer treatment, previous surgery or trauma, and are available from local NHS Trusts through commissioned pathways-referral to dermatologists or oncologist as appropriate. Patients requiring reconstruction of the eyebrow following cancer or trauma will be treated within existing contracts. MECCG does not routinely commission treatments for the correction of male or female pattern baldness as it is a normal process of ageing. MECCG does not routinely commission hair transplantation or the use of the ‘Interlace’ or other hair systems, regardless of gender. Patients who are already being treated and funded by the NHS and who require ongoing funding for maintenance and support will be considered on an individual patient basis, and continued funding only granted in clinically exceptional circumstances. Funding for patient outside this policy will only be granted in exceptional clinical circumstances. 60 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Low Clinical Priority Procedures Status: Not Funded The following procedures have been assessed as Low Clinical Priority by Mid Essex CCG and will not be funded unless there are exceptional clinical circumstances. Applications for funding for these procedures can be made to the Exceptional Case Team but should only be made where the patient demonstrates true clinical exceptionality. This list includes recently assessed areas of care, and providers must not assume that because a treatment/intervention/procedure is not included in this list that by default it will be funded. Mid Essex CCG’s policy is that treatments/interventions/procedures not currently included in established care pathways (as identified for example in the Schedules to the service agreements with acute care provides) or identified for funding through the commissioning process are not routinely funded. Cosmetic/plastic surgery is not routinely funded outside commissioned pathways e.g. following surgery, trauma or for congenital malformation as detailed in policies or commissioned pathways. Post-surgical reconstruction is commissioned as per service level agreements for surgical services. The effect of the problem on essential activities of day-to-day living is a key factor in decision-making. In such cases, psychological treatment such as counselling or cognitive behavioural therapy may be considered as an appropriate alternative to surgery. It is not necessary to obtain a psychiatric opinion to support an application. MECCG expects mental health professionals to treat related problems through established procedures commissioned from the mental health trust and this would not include surgery. MECCG Exceptional Cases Panel consistently takes the view that psycho-social considerations should not be a justification for surgery. Where referrers consider that there may be exceptional clinical circumstances they must provide details of these exceptional clinical circumstances bearing in mind the points above. All individual funding requests should be accompanied by suitable clinical photography that demonstrates the extent of the problem. This, of course, would be subject to patient consent. Policy statement: Acne Vulgaris MECCG does not routinely fund resurfacing or other surgical treatments. Policy statement: Aesthetic Facial Surgery MECCG does not routinely fund Aesthetic Facial Surgery. Policy statement: Autologous Cartilage Transplantation MECCG does not routinely fund autologous cartilage transplantation Policy statement: Bobath Therapy MECCG commissions a number of Bobath trained therapists as part of its routine therapy services. Referral for assessment and/or treatment at specific Bobath centres will not be routinely funded. 61 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Policy statement: Bone Anchored Hearing Aid MECCG does not commission BAHAs; this is the responsibility of NHS England. NHS England routinely commissions unilateral BAHAs for patient’s meeting the commissioning policy but will not normally commission bilateral Bone Anchored Hearing Aid (BAHA) implantation. Such requests for funding will only be considered through an exceptions route. See full policy: http://www.england.nhs.uk/ourwork/d-com/spec-serv/policies/ Policy statement: Breast Asymmetry/Breast Reduction/Mastopexy (including revision and replacement) MECCG does not routinely fund surgery or treatments e.g. prosthetics for Breast Asymmetry or Breast Reduction or Mastopexy (including revision and replacement). Policy statement: Chronic Fatigue Syndrome Patients should be managed by GPs as recommended by NICE clinical guideline number 53 – Chronic Fatigue syndrome/ myalgic encephalomyelitis (or encephalopathy) – Diagnosis and management of CFS/ME in adults and children’. However MECCG will not routinely fund referral to a secondary care specialist in CFS/ME care for assessment or treatment on either an in-patient or outpatient basis outside routinely commissioned pathways. The clinical guideline also states the following: Do not use the following drugs for the treatment of CFS/ME: monoamine oxidase inhibitors, glucocorticoids (such as hydrocortisone), mineralocorticoids (such as fludrocortisone), dexamphetamine, methylphenidate, thyroxine or antiviral agents. There is insufficient evidence for the use of supplements – such as vitamin B12, vitamin C, co-enzyme Q10, magnesium, NADH (nicotinamide adenine dinucleotide) or multivitamins and minerals – for people with CFS/ME, and therefore they should not be prescribed for treating the symptoms of the condition. However, some people with CFS/ME have reported finding these helpful as a part of a self-management strategy for their symptoms. People with CFS/ME who are using supplements should be advised not to exceed the safe levels recommended by the Food Standards Agency Policy statement: Cochlear Implants NHS England commissions cochlear implantation services. This includes the multidisciplinary assessment, surgical implantation and rehabilitation (including maintenance of the implant). MECCG only commissions the initial general hearing assessment for patients who go on to have specialist assessment for cochlear implants. http://www.england.nhs.uk/wp-content/uploads/2013/04/d09-ps-a.pdf 62 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Policy statement: Complementary and Alternative Therapies MECCG does not routinely fund standalone treatment with complementary or alternative therapies. This restriction applies equally to primary and secondary care provision, and GPs must not prescribe such products on FP10s. This includes (but is not exhaustive): Acupuncture Hypnosis Alexander Technique Homeopathy Applied Kinesiology Massage Aromatherapy Meditation Autogenic Training Naturopathy Ayurveda Nutritional Therapy Chiropractic Environmental Medicine Reflexology Osteopathy Reiki Healing Shiatsu Herbal Medicine Other alternative therapies Policy statement: Continuous Glucose Monitoring in Type 1 Diabetes MECCG does not routinely fund continuous glucose monitoring in adults, children or young people with Type 1 Diabetes. Mid Essex CCG commissions the provision of continuous subcutaneous insulin infusions (via insulin pumps) in line with NICE Technology Appraisal 151. In accordance with NICE principles and the ethos of NICE clinical guideline Type 1 diabetes in adults: diagnosis and management (nice.org.uk/guidance/ng17) the CCG supports funding of the insulin pump with the lowest acquisition cost that meets the clinical needs of the patient, and without consideration of a patient’s desire to self-fund CGM. Co-funding, which involves both private and NHS funding for a single episode of care, is not permitted for NHS care. The choice of pump in very young children should take into account the ability to deliver a very low basal rate The CCG recognises that NICE guidelines [NG17] and NICE guidelines [NG18] on management of type 1 diabetes in adults, children and young people include recommendations on use of CGM. This policy is intended as a holding position until resources are available Policy statement: Dental Procedures (Orthodontics, Wisdom Teeth) Commissioning of all dental treatments and procedures including orthodontic treatment and wisdom tooth removal is now the responsibility of NHS England, and is therefore not commissioned or funded by MECCG Policy statement: Face Lifts and Brow Lifts (Rhytidectomy) MECCG does not routinely fund Face Lifts and Brow Lifts. Policy statement: Facet Joint Injections and Medial branch blocks MECCG does not routinely fund Therapeutic facet joint injections and medial branch blocks Facet joint injections are only commissioned for diagnostic assessment and only in patients being assessed for surgical management of chronic spinal pain. 63 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Policy statement: Female Sterilisation MECCG does not routinely fund female sterilisation. Policy statement: Fibroid Embolisation / Uterine Artery Embolisation MECCG does not routinely fund Fibroid Embolisation / Uterine Artery Embolisation. Policy statement: Functional Electrical Stimulation (FES) MECCG does not routinely fund Functional electrical stimulation (FES) for the treatment of dropped foot in patients with neurological conditions as this is considered a low priority procedure For patients already being treated and funded by the NHS, who require ongoing funding for maintenance and support, prior approval will be required and the following criteria apply: The patient will have objectively demonstrated (using validated tools) that the use of FES is still clinically appropriate, e.g. by o foot drop which impedes gait and evidence that this is not satisfactorily controlled using ankle–foot orthoses o gait improvement from its use Policy statement: Gastroelectrical Stimulation MECCG does not routinely fund Gastric nerve/Gastro electrical simulation for use in intractable nausea and vomiting from idiopathic or diabetic gastroparesis. Policy statement: Gender Dysphoria MECCG does not commission gender identity disorder services. This is the responsibility of NHS England. NHS England commissions gender identity disorder services from Specialist Gender Identity Disorder Clinic Centres. This includes specialist assessment, non-surgical care packages, transgender surgery and associated aftercare. In this context, commissioning includes deciding which treatments should be commissioned by the NHSE – in the light of clinical and cost effectiveness information – and which should not. Clinical Commissioning Groups (CCGs) do not commission any elements of this service, regardless of whether or the NHSE funds them. MECCG will not accept requests to fund these treatments. GPs are responsible for the initiation and on-going prescribing of hormone therapy and for organising blood and other diagnostic tests as recommended by the Specialist Gender Identity Disorder Clinic Centres. GPs should ensure that a patient has been accepted on an NHS treatment pathway at an NHS England commissioned Specialist Gender Identity Disorder Clinic before accepting any prescribing responsibility for hormone therapy. 64 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Policy statement: Gynaecomastia MECCG does not routinely fund surgery for gynaecomastia. Policy statement: Hirsutism/hair depilation MECCG does not routinely fund hair depilation procedures or medication e.g. Vaniqa. Policy statement: IVF (Assisted Conception Using IVF/ICS/IUI -Specialist Fertility Services) MECCG does not routinely fund Specialist Fertility Services- including assisted conception using IVF/ICS/IUI. Policy statement: Liposuction MECCG does not routinely fund liposuction procedures. Policy statement: Rhinophyma MECCG does not routinely fund rhinophyma. Policy statement: Sacroneuromodulation MECCG does not routinely commission sacroneuromodulation. NHS England are responsible for commissioning Sacroneuromodulation for faecal and urinary incontinence. Policy statement: Skin Contouring MECCG does not routinely fund skin contouring Policy statement: Snoring MECCG does not routinely fund procedures for simple snoring where this is the sole problem. Surgical interventions for simple snoring include, but may not be limited to, the following and will not be routinely funded: Uvulopalatopharyngoplasty (UP3 or UPPP) Laser assisted uvulopalatoplasty (LAUP) Radiofrequency ablation (RFA) Soft palate implants If associated with sleep apnoea see Sleep Studies Policy statement: Surrogacy MECCG does not routinely fund surrogacy. 65 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Policy statement: Tattoo Removal MECCG does not routinely fund procedures for the removal of tattoos. Policy statement: Temporomandibular Joint Replacement MECCG does not routinely fund temporomandibular joint replacement. Policy statement: Temporalmandibular Joint Retainers and Appliances MECCG does not routinely fund TMJ appliances e.g. Therabite. GPs should not accept requests to prescribe such appliances on FP10s. Policy statement: Toric intraocular lens implant for astigmatism MECCG does not routinely fund toric intraocular lens implants as there is insufficient evidence to demonstrate safety, clinical and cost effectiveness. Toric IOLs refer to astigmatism correcting intraocular lenses used at the time of cataract surgery to decrease post-operative astigmatism. Policy statement: Vasectomies MECCG does not routinely fund vasectomies. 66 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED Back to index Policy statement: Interventional Procedure Guidance NICE issues Interventional Procedure Guidance (IPGs) with the aim of protecting the safety of patients and supporting the NHS in the process of introducing new procedures. The IPGs are not covered by the Secretary of State’s directions to NHS organisations to fund the implementation of NICE recommendations within a given timescale because this direction relates only to NICE Technology Appraisal Guidance (TAGs). Interventional Procedure Guidance makes recommendations on the safety of the procedure and how well it works. The guidance does not recommend whether the NHS should fund a procedure; or not and these decisions are therefore for the CCGs. ME CCG recognises that it is not within the remit of the NICE IPG Programme to evaluate the cost-effectiveness of interventional procedures or to advise the NHS whether interventional procedures should be funded. Specific commissioning position with respect to different categories of IPG 1.1 Special Arrangements Mid Essex CCG will not routinely fund health care interventions that are subject to a NICE IPG where the IPG states: Current evidence on safety is inadequate. Current evidence on efficacy is inadequate. Evidence of safety and efficacy is on small numbers of patients and of limited quality. No major safety concerns, but efficacy has not been shown. Evidence is limited to a small number of patients. Good short term efficacy but little evidence of long term efficacy. There is adequate evidence of safety and efficacy but the technical demands are such that is should not be used without special arrangements. Evidence for short term efficacy is limited and long term outcomes are uncertain. 1.2 Research Only Mid Essex CCG will not routinely fund health care interventions that the NICE IPG programme has recommended should only be undertaken in the context of research. Clinicians wishing to undertake such procedures should ensure they fulfil the normal requirements for undertaking research. Where there is a possibility that there may be impacts on NHS funded care following the cessation of the trial, or a patient’s completion of a trial, clinicians must discuss this with the CCG at the earliest opportunity. 1.3 Do not use Mid Essex CCG will not fund health care interventions where a NICE IPG recommends that the intervention should not be used in the NHS. 67 Please check website for latest versions of policies as may be subject to change throughout the year: Version 6 released 12th February 2016 UNCONTROLLED WHEN PRINTED