Service Restriction Policy Additional Information

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1 Service Restriction Policy Additional Information Purpose of this document This document is intended to be read alongside the Service Restriction Policy. This document provides detail of the criteria that clinicians must use as a basis for an application of prior approval or to ensure that procedures carried out meet the criteria when retrospectively audited. Page 1 of 46

2 OPCS codes D151, D158, D159, D202, D203, D208, D209, D288, D289 Adenoidectomy Combined with Grommets Adenoidectomy combined with grommets may be considered in children who fulfil the criteria for grommets (see Grommet criteria) as follows: 1. The child has persistent bilateral otitis media with effusion, with a hearing loss, measured on two occasions separated by 3 months, and of at least 25 dbhl averaged at 0.5, 1, 2 and 4 khz (1). 2. The child has persistent bilateral otitis media with effusion, with any degree of hearing loss there is documented evidence of significant developmental, social or educational delay. 3. The child has suffered more than 6 episodes of acute otitis media in 12 months. 4. The presence of an unsafe retraction pocket in the tympanic membrane. In a Cochrane review of grommets 1, the reviewers note some improvement in outcomes that look at adenoidectomy and grommet insertion compared to grommet insertion alone. The other indication for adenoidectomy (usually in conjunction with tonsillectomy) is: Sleep apnoea (usually diagnosed with strong clinical suspicion by an ENT surgeon sleep studies are not likely to be a cost-effective diagnostic tool in most cases). A literature review 2 in 2005 found that, in children, including those that are obese, adenotonsillectomy was curative for %. However, a Cochrane review 3 noted that there is no randomised trial data relating to adeno-tonsillectomy for obstructive sleep apnoea in children and more research is needed. In all cases, there should be evidence that the surgeon has obtained adequate informed consent, including discussing the potential risks and benefits of surgery. References 1. Cochrane Database of Systematic Reviews. Grommets (ventilation tubes) for hearing loss associated with OME in children 2. Ryan, C.F (2005). Sleep 9: An approach to treatment of obstructive sleep apnoea/hypopnoea syndrome including upper airway surgery. Thorax (60); Lim,J and McKean,M (200). Adenotonsillectomy for obstructive sleep apnoea in children. Cochrane Database of Systematic Reviews Issue 3. Patient Information Leaflet NHS Choices Patient Information Leaflet Adenoidectomy Page 2 of 46

3 OPCS codes: Blepharoplasty The Commission will only fund blepharoplasty when the following criteria are met; 1. At least one of the following must be present: a roll of upper eyelid skin hangs over the tips of some or all of the upper lid lashes a roll of upper eyelid skin rests on the lashes deflecting the lashes downwards from the lid margin. 2. A recognized visual field assessment is undertaken that confirms the patient has a defect in the superior field in keeping with the excess skin of the eyelid. The visual field assessment should record that the defect is at least 22 degrees. Page 3 of 46

4 OPCS codes: Breast Asymmetry Female The Commissioner will only fund breast reduction surgery to correct breast asymmetry when ALL the following criteria are met: 1. Sexual maturation has been reached. 2. BMI as measured by the NHS is between 18 and 25 and has been within this range for 1 year as measured and recorded by the NHS 3. Confirmed non-smoker and/or documented abstinence prior to procedure 4. Asymmetry equal to, or greater, than 30% difference in volume between the breasts as measured by 3D body scan to assess breast volume* Please Note: Clinical photographs are NOT required for this procedure. *Young women with juvenile macromastia (juvenile gigantomastia) can be treated prior to reaching sexual maturation. Page 4 of 46

5 OPCS codes: Breast Reduction Female The Commissioner will only fund breast reduction surgery (reduction mammoplasty) when ALL the following criteria are met: 1. Sexual maturation has been reached* 2. BMI as measured by the NHS is between 18 and 25 and has been within this range for 1 year as measured and recorded by the NHS 3. Confirmed non-smoker and/or documented abstinence prior to procedure 4. Breast size is equal to or greater than 1000cc in each breast* 5. Ratio of combined breast volume to adjusted partial torso volume is equal to or greater than 13%b as measured by 3D Body scan to assess breast volume. Please note, clinical photographs are NOT required for this procedure *Young women with juvenile macromastia (juvenile gigantomastia) can be treated prior to reaching sexual maturation. Page 5 of 46

6 OPCS codes: Breast Enlargement Female The Commissioner will only routinely fund breast enlargement (augmentation mammoplasty) surgery if one of the following criteria is met: 1. Developmental failure resulting in unilateral or bilateral absence of breast tissue/asymmetry e.g. Poland Syndrome/ Tuberous Breast Deformity 2. To correct breast asymmetry due to trauma or as a result of surgery (mastectomy or lumpectomy) that results in a significant deformity. In all other circumstances, The Commissioner will only fund breast augmentation surgery to correct breast asymmetry when ALL the following criteria are met: 1. Sexual maturation has been reached. 2. BMI as measured by the NHS is between 18 and 25 and has been within this range for 1 year as measured and recorded by the NHS 3. Confirmed non-smoker and/or documented abstinence prior to procedure 4. Asymmetry equal to, or greater, than 30% difference in volume between the breasts as measured by 3D body scan to assess breast volume. Page 6 of 46

7 OPCS codes: Breast Implant removal and insertion Female The Commissioner will fund the removal of breast implants for any of the following indications in patients who have undergone cosmetic augmentation mammoplasty that was performed either in the NHS or privately: 1. Breast disease 2. Implants complicated by recurrent infections 3. Implants with capsule formation that is associated with severe pain 4. Implants with capsule formation that interferes with mammography 5. Intra or extra capsular rupture of silicon gel-filled implants For women whose breast implants are removed in strict compliance with the criteria above whose original surgery was funded by the NHS, the commissioner will also fund insertion of replacement implants. The commissioner will not fund the insertion of replacement implants where the original surgery was funded privately. The commissioner will NOT fund or part fund procedures undertaken in the private sector, irrespective of whether part of that procedure involves removal of a breast implant. Page 7 of 46

8 OPCS codes: Biological Mesh Greater Nottinghamshire CCGs will approve the use of biological mesh in the following indications: Hernia: Primary ventral and inguinal hernia repair in non-infected fields Recurrent hernias, reinforced hernia repair Hernia prophylaxis Hernia repair in the contaminated or potentially contaminated fields (most widely used) Complex abdominal wall hernia repair Breast reconstruction: Mastectomy Reconstructive surgery Pelvic organ prolapse: Pelvic organ prolapse (POP) Laparoscopic ventral mesh rectopexy (rectal prolapse) Biological mesh is classified by: 1. Source usually human, porcine or bovine 2. Site dermis, small intestine submucosa, pericardium 3. Processing method cross-linked, non-cross linked, sterilised, non-sterilised Page 8 of 46

9 OPCS codes: A651, A658,A659, T723 Carpel Tunnel Patients with wasting of the hand muscles should be urgently referred and are outside the scope of this policy. Greater-Nottinghamshire CCGs commission surgery for carpal tunnel syndrome on a restricted basis. Nerve conduction studies (EMG) are NOT needed to confirm the diagnosis and are not funded by the Greater-Nottinghamshire CCGs. 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 once prior to referral for consideration of surgery All GPs should seek access to carpal tunnel injections prior to referral to surgery. Patients with Carpal Tunnel Syndrome should be referred if any of the following criteria 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 The referral 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. Rationale: Conservative treatment offers short-term benefit (1-3 months) similar to surgery and many patients symptoms may resolve for at least a year after conservative treatment. After corticosteroid injection, up to 50% of patients may report minor or no symptoms at one year. The benefits of conservative therapy are seen early after treatment and then decrease while the benefits of surgery take longer to be fully realised. Corticosteroid injections and nocturnal splinting are effective conservative therapies. Therefore patients would not normally be referred for carpal tunnel syndrome unless they Page 9 of 46

10 have had a local steroid injection into the carpal tunnel together with the provision of night splints. In the longer term (3-18 months), surgery is better than conservative therapy with up to 90% of patients reporting complete or much improvement at 18 months. A trial of conservative therapy offers the opportunity to avoid surgery for some patients. Patient information leaflet NHS Choices Carpal Tunnel Treatment Information Leaflet Page 10 of 46

11 OPCS codes: Removal of Chalazion Commissioners would not normally fund the removal of Chalazion in secondary care however if the patient meets the following criteria then funding will be available via prior approval; The cyst is acutely infected Has not responded to topical treatments or antibiotics The cyst is not infected but has been present for over 6 months Conservative treatments have been tried and failed Conservative treatments include hot compresses and anti-biotics. Page 11 of 46

12 OPCS codes: T521, T522, T528, T529, T541, T548, T549, T525, T526, T558, T559, T561, T562, T571, T574 Dupuytrens Contracture Symptoms of Dupuytrens contracture are often mild and painless and do not require treatment. Patients may be managed with observation if the contractures themselves are not functionally limiting. Commissioners will fund surgical intervention where one or more of the criteria are met: Metacarpophalangeal (MCP) joint contracture of 30 (inability to place hand flat on table), Any degree of proximal interphalangeal (IP) joint contracture, First web contracture, Significant functional loss which prevents activities of daily living, e.g. washing, dressing Commissioners will fund collagenase clostridium histolyticum (CCH) as an option for treating Dupuytren's contracture with a palpable cord in adults ONLY if all of the following apply: There is evidence of moderate disease (functional problems and metacarpophalangeal joint contracture of 30 to 60 and proximal interphalangeal joint contracture of less than 30 or first web contracture) plus up to 2 affected joints. Percutaneous needle fasciotomy (PNF) is not considered appropriate, but limited fasciectomy is considered appropriate by the treating hand surgeon. The choice of treatment (CCH or limited fasciectomy) is made on an individual basis after discussion between the responsible hand surgeon and the patient about the risks and benefits of the treatments available. One injection is given per treatment session by a hand surgeon in an outpatient setting. Page 12 of 46

13 The Commissioner does not fund radiation therapy for early Dupuytrens Reference 1. NICE Clinical Knowledge Summary 2. British Society for Surgery to the Hand Evidence for Surgical Treatment Guide: Dupuytrens Disease 3. British Society for Surgery of the Hand Evidence for Surgical Treatment Process Manual (Nov 2016) Patient Information Leaflet NHS Choices Patient Information Leaflet Dupuytrens Contracture Page 13 of 46

14 OPCS codes: Q103, Q108, Q109 Dilatation and Curettage (D&C) / Hysteroscopy Including the treatment of menorrhagia (Heavy Menstrual Bleeding) Hysteroscopy will be funded in the investigation and management of heavy menstrual bleeding only when it is carried out: As an investigation for structural and histological abnormalities where ultrasound has been used as a first line diagnostic tool and where the outcomes are inconclusive, for example to determine the exact location of a fibroid or the exact nature of the abnormality. Or Where dilatation is required for non-hysteroscopic ablative procedures. Or Hysteroscopy should be considered immediately prior to the ablative procedure to ensure correct placement of the device (unless pre-operative ultrasound assessment has already been undertaken). Or 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. Dilation and Curettage will not be funded in the following circumstances: As a diagnostic tool for heavy menstrual bleeding. Or As a therapeutic treatment for heavy menstrual bleeding. Reference D&C and hysteroscopy will only be used in line with NICE guidance (CG44, 2007). Patient information leaflet NHS Choices Patient Information Leaflet D&C Page 14 of 46

15 OPCS Codes; T591, T592, T593, T594,T598, T599, T601, T602, T603, T604, T608, T609 Ganglion cysts Treatment Surgical excision is not commissioned for cosmetic reasons. Treatment of ganglia is only funded by the NHS in the circumstances detailed below; Significant functional impairment (significant restriction of work/domestic/care duties); significant pain; neurological deficit; weakness of the joint; inhibition of nail growth. Awareness of frequency of spontaneous resolution, likelihood of recurrence and possible complications of excision Discuss with patients frequency of spontaneous resolution likelihood of recurrence possible complications of treatment Page 15 of 46

16 OPCS codes: D151 - Myringotomy with insertion of ventilation tube through tympanic membrane Grommet insertion for Glue Ear (otitis media with effusion) and recurrent acute otitis media in children. Surgical criteria for grommet insertion Grommet insertion will only be funded in children who meet one of these criteria: 5. The child has persistent bilateral otitis media with effusion, with a hearing loss, measured on two occasions separated by 3 months, and of at least 25 dbhl averaged at 0.5, 1, 2 and 4 khz (1). 6. The child has persistent bilateral otitis media with effusion, with any degree of hearing loss there is documented evidence of significant developmental, social or educational delay. 7. The child has suffered more than 6 episodes of acute otitis media in 12 months. 8. The presence of an unsafe retraction pocket in the tympanic membrane. Background Definitions: 1) Acute otitis media: Acute infection of the middle ear cleft. It is usually a self-limiting condition characterized by pain and fever lasting a few days which may be followed by up to 2 weeks of discharge. 2) Recurrent acute otitis media: The discrete recurrence of individual episodes rather than the prolonged course of one episode. 3) Middle ear effusion/otitis media with effusion/glue ear: These terms overlap and care needs to be taken with their precise meaning in each context in which they are used. Page 16 of 46 a. A middle ear effusion simply refers to the presence of fluid in the middle ear cleft under the ear drum. b. Otitis media with effusion may on occasion be used interchangeably with the term Glue ear, or may be used specifically to refer to middle ear fluid occurring after an episode of (acute) otitis media. c. Glue ear tends to suggest the presence of fluid in the middle ear cleft which has persisted and is causing hearing loss. Transient periods of middle ear effusion commonly follow episodes of upper respiratory tract infection and episodes of acute otitis media, but in many cases there is no identifiable cause of the effusion. Most middle ear effusions resolve within 3 months and cause no noticeable effects on the child s development so do not require specialist assessment and advice.

17 Middle ear fluid always causes a conductive hearing loss, but the magnitude of the loss is variable. The effects of the hearing loss on an individual are even more variable and often unpredictable, ranging from negligible to a significant disability compromising speech and language, social and behavioral development. Factors affecting the amount of disability caused include whether the impairment is unilateral or bilateral, the amount of impairment, its duration, the age of the child, the child s social and educational circumstances and any other co-morbidities the child may have. It is the global impact of the effusions on the child s life which is the important factor in determining treatment, not the presence of effusions per se. Available treatments for hearing loss associated with glue ear includes hearing aids or grommets. Guidance Referral of children for an ENT opinion is advised if: The child has hearing loss suggestive of sensori-neural deafness (urgent referral); There is a reasonable suspicion of hearing loss plus a delay in speech or language development, poor educational progress, social or behavioral problems or another disability such as Down s syndrome or cleft palate (should be seen soon); The child has persistent hearing loss detected on two occasions separated by 3 months or more; NICE guidelines suggest a threshold of 25 dbhl or worse in the better ear; The child has suffered more than 6 episodes of acute otitis media in 12 months; The otoscopic features are atypical and accompanied by a foul smelling discharge lasting for more than 6 weeks, suggestive of cholesteatoma (urgent referral). References 1. NICE. Surgical management of otitis media with effusion in children Patient information Leaflet NHS Choices Patient Information Leaflet Grommets Page 17 of 46

18 OPCS Codes; H511, H512, H513, H518, H519, H521, H522, H523, H524, H528, H529 Haemorrhoidectomy Background: Haemorrhoids are a common condition affecting a third of the general population. Peak incidence of Haemorrhoids is between ages 45 to 65 years [1] [2]. Symptomatic Haemorrhoids increase in prevalence in women during pregnancy and postpartum periods, but subsequently resolve. Most Haemorrhoids can be treated in primary care with dietary advice and avoidance of straining, and do not benefit from surgical intervention [3, 4]. History alone does not provide a diagnosis of Haemorrhoids. Physical examination including digital rectal examination and proctoscopy is a minimum requirement to confirm suspected diagnosis of Haemorrhoids [4] and to exclude other anorectal pathology. All cases of Haemorrhoids should be investigated for anaemia and other red flag signs and symptoms. If positive, these cases should be referred on appropriately under the two week wait criteria [5]. Haemorrhoidscan be classified as internal or external relating to their position of origin either above or below the dentate line. Haemorrhoids are graded into 4 groups by the Goligher classification [3] defined by their degree of prolapse. 1 st degree Haemorrhoids: Bleed but do not prolapse 2 nd degree Haemorrhoids: Prolapse but reduce spontaneously 3 rd degree Haemorrhoids: Prolapse but reduced manually 4 th degree Haemorrhoids: Permanently prolapsed and irreducible Criteria for commissioning: As a non-priority condition, haemorrhoidectomy will only be commissioned if conservative treatment has failed and one of the following three criteria is present [6] 1. Haemorrhoids are recurrent; 2. Haemorrhoids are causing persistent bleeding; 3. Haemorrhoids cannot be reduced For 1 st and 2 nd degree Haemorrhoids where conservative management has failed, rubber band ligation would constitute the first line intervention, with stapled haemorrhoidectomy/ haemorrhoidal artery ligation only to be used if rubber band ligation has failed. For 3 rd degree Haemorrhoids where conservative management has failed, rubber band ligation or haemorrhoidectomy/ haemorrhoidal artery ligation could be used as first line interventions. For 4 th degree Haemorrhoids, haemorrhoidectomy or haemorrhoidopexy should be the first line intervention. First line treatment: For first, second, and third degree Haemorrhoids, dietary management consisting of adequate fluid and fibre intake remains the treatment of choice. In addition bulk Page 18 of 46

19 forming laxatives, non-opioid analgesia and topical haemorrhoid preparations can be prescribed for symptomatic relief [3, 4, 7-10]. For first, second and third degree Haemorrhoids refractive to conservative management with diet, rubber band ligation remains the intervention of choice [3, 11-14], and is more efficacious than injection sclerotherapy. Stapled haemorrhoidectomy may also be used in third degree Haemorrhoids, as the probability of recurrence is lower. [3, 11, 15] Rubber band ligation offers economic advantages as a day case procedure and patients recover quicker when used appropriately. Stapled haemorrhoidopexy was considered appropriate for people with fourth-degree Haemorrhoids for whom residual external prolapse or skin tags would not be a concern [15]. Alternate treatment for fourth degree Haemorrhoids remains traditional surgical haemorrhoidectomy [3, 10, 15]. Treatment for small thrombosed Haemorrhoids remains unchanged with ice packs, analgesia and stool softeners recommended for symptomatic relief. Symptoms usually resolve within days. Emergency surgery to excise necrotic tissue and remove the haemorrhoid may occasionally be appropriate. Second line treatment: For Haemorrhoids refractive to rubber band ligation, stapled haemorrhoidectomy is recommended by NICE in place of traditional surgical haemorrhoidectomy [15]. Models of device evaluated in the evidence review on stapled haemorrhoidopexy were the HCS33 (PPH01 model) and CDH33 model [15]. Stapled haemorrhoidopexy was found to be as effective as conventional haemorrhoidectomy when used appropriately and offered immediate benefits in terms of postoperative pain [16]. In addition, taking into account the requirements for postoperative pain management and other support during inpatient stay and after discharge, stapled haemorrhoidopexy was thought to potentially lead to modest cost savings [15]. Current evidence on haemorrhoidal artery ligation shows that this procedure is an efficacious alternative to conventional haemorrhoidectomy or stapled haemorrhoidopexy in the short and medium term, and that there are no major safety concerns [17]. Key efficacy outcomes are less postoperative pain than other treatments, resolution of Haemorrhoids, and relief of symptoms such as bleeding, prolapse, swelling, pain, soreness and itching in the short and long term [17]. This procedure may therefore be used provided that normal arrangements are in place for clinical governance, consent and audit. References: 1. Abramowitz, L., et al., [Clinical practice guidelines for the treatment of hemorrhoid disease]. Gastroenterol Clin Biol, (6-7): p Johanson, J.F. and A. Sonnenberg, The prevalence of hemorrhoids and chronic constipation. An epidemiologic study. Gastroenterology, (2): p Lohsiriwat, V., Approach to hemorrhoids. Curr Gastroenterol Rep, (7): p Hussain, J.N., Haemorrhoids. Essentials of clinical management. Aust Fam Physician, (1): p Referral Guidelines for Suspected Cancer in Adults and Children. NICE Clinical Guidelines, No England, N., Interim clinical commisioning policy: Haemorrhoidectomy.November Page 19 of 46

20 7. Alonso-Coello, P., et al., Laxatives for the treatment of hemorrhoids.cochrane Database Syst Rev, 2005(4): p. Cd Alonso-Coello, P., et al., Fiber for the treatment of hemorrhoids complications: a systematic review and meta-analysis. Am J Gastroenterol, (1): p NICE, NHS Clinical knowledge summaries: Haemorrhoids. 10. Rakinic, J. and V.P. Poola, Hemorrhoids and fistulas: new solutions to old problems. Curr Probl Surg, (3): p Peng, B.C., D.G. Jayne, and Y.H. Ho, Randomized trial of rubber band ligation vs. stapled hemorrhoidectomy for prolapsed piles. Dis Colon Rectum, (3): p ; discussion Kelly, M., NICE guidance does not recommend e-cigarettes. BMJ 2014;348:g315, (7942). 13. Drakeford, M., Mark Drakeford: E-cigarettes 're-normalising' smoking Lu, L.Y., Y. Zhu, and Q. Sun, A retrospective analysis of short and long term efficacy of RBL for hemorrhoids. Eur Rev Med Pharmacol Sci, (20): p NICE, Stapled haemorrhoidopexy for the treatment of haemorrhoids 16. Laughlan, K., et al., Stapled haemorrhoidopexy compared to Milligan-Morgan and Ferguson haemorrhoidectomy: a systematic review. Int J Colorectal Dis, (3): p NICE, Haemorrhoidal artery ligation: Technology and current evidence Page 20 of 46

21 OPCS Codes; W791, W792, W799, W151,W152, W153, W154, W155, W156, W158, W159, W591, W592, W593, W594, W596, W597, W598, W599 Hallux Valgus (bunions) Hallux valgus commonly known as bunions can cause varying degree of pain with limitation of function and mobility as an effect of pressure from shoes over the medial prominence of the metatarsal head. Conservative management such as orthoses does not always help to recover from symptoms and improve the long-term outcome. Surgical intervention can bring significant improvements in symptoms and clinical parameters, but is not always without a risk. Surgery for asymptomatic bunions, for primarily cosmetic reasons, will not be funded by the commissioners and concerns about the cosmetic appearance of feet should not be referred onto secondary care. In the first instance, conservative management techniques should be employed. These techniques include: Avoid high heel shoes Wear wide fitting leather shoes which stretch Non-surgical treatments such as bunion pads, splints, insoles or shields. Simple analgesia. Greater Nottinghamshire CCGs will only fund surgical treatment of bunions if the patient meets the following criteria. The patient has been reviewed by podiatry services Self-care advice and analgesia has been tried and symptoms are not improving (this must be evidenced in the prior approval application) Severe pain unrelieved by conservative measures Recurrent infection Recurrent Ulcers Page 21 of 46

22 OPCS codes: Q071, Q072, Q073, Q074Q075, Q076, Q078, Q079, Q081, Q082Q083, Q088, Q089 Hysterectomy for heavy menstrual bleeding Non Cancer Hysterectomy for non-cancerous heavy menstrual bleeding will only be funded by Greater Nottinghamshire CCGs within NICE guidance and when; There has been an unsuccessful trial and appropriate clinical assessment, with a levonorgestrel-releasing intrauterine system LNG-IUS, e.g. Mirena, unless contraindicated, for at least 12 months which has not successfully relieved symptoms or has produced unacceptable side effects. And At least one alternative treatment has failed, is not appropriate or is contraindicated in line with NICE guidelines. Alternative hormonal treatment Other hormone methods (e.g. combined oral contraceptives, injected progesterons, Gn- RH analogue). In line with NICE guidance. NSAIDs and Tranexamic Acid. And The following are not clinically appropriate: 1. Endometrial ablation if normal uterus or if LNG-IUS contraindicated or if ablation is contraindicated e. g. previous multiple caesarean section 2. Uterine Artery Embolisation (for fibroids under 3cm) 3. Myomectomy (for fibroids over 3cms) 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. References: 1. Brown JS, Sawaya G, Thom DH, Grady D. Hysterectomy and urinary incontinence: a systematic review. Lancet. 2000; 356: Clarke J. Treatment of heavy menstrual bleeding. BMJ 2010; 341: 353. Page 22 of Lethaby A, Shepperd S, Farquhar C, Cooke I. Endometrial resection and ablation versus hysterectomy for heavy menstrual bleeding. Cochrane Database of Systematic Reviews 1999, Issue 2. Art. No.: CD DOI: / CD National Institute for Health & Care Excellence (NICE) Heavy menstrual bleeding, Jan National Institute for Health and Care Excellence (NICE) Heavy Menstrual Bleeding January 2007.

23 Patient Information Leaflet NHS Choices Patient Information Leaflet Heavy Periods Treatment Page 23 of 46

24 Insulin Pump OPCS Codes Greater Nottinghamshire CCGs will fund initiation of continuous subcutaneous insulin infusion or insulin pump' therapy as a treatment for adults and children 12 years and over with type 1 diabetes mellitus if: Attempts to reach target haemoglobin A1c (HbA1c) levels with multiple daily injections result in the person having disabling hypoglycaemia', or HbA1c levels have remained high (8.5% or above) with multiple daily injections (including using long-acting insulin analogues if appropriate) despite the person and/or their carer carefully trying to manage their diabetes The person has attended a CCG approved diabetes educational course for example DAFNE. Insulin pump therapy should only be started by a trained specialist team. This team should include a doctor who specialises in insulin pump therapy, a diabetes nurse and a dietitian (someone who can give specialist advice on diet). This team should provide a structured education programme and advice on diet, lifestyle and exercise that is suitable for people using insulin pumps. Insulin pump therapy is not recommended for people with type 2 diabetes mellitus Reference (NICE Technology Appraisal 151: NICE GUIDANCE TA151) Patient information leaflet NHS Choices Patient Information Leaflet Treatment for Type 1 Diabetes Page 24 of 46

25 OPCS codes: W851, W852, W859, W861, W868, W869 Knee Arthroscopy Cases for knee arthroscopy will only be funded if they meet the criteria below: Arthroscopy of the knee can be undertaken where a competent clinical examination and MRI scan has demonstrated clear evidence of an internal joint derangement (acute 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 Acute meniscal repair or resection Repair of MRI proven chrondral defects AC ligament reconstruction/repair Synovectomy/symptomatic plica To assist selection of appropriate patients for unicompartmental 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. Arthroscopy for degenerative tears. In line with NICE guidance CG177; 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 ) Reference NICE guidance CG177 Patient Information leaflet NHS Choices Patient Information Leaflet arthroscopy Page 25 of 46

26 Microsuction for the removal of ear wax OPCS Codes D152, D048, D071,D072, D073, D078, D085, D088, D089 Removal of ear wax in secondary care will not be funded. If removal of ear wax is required to carry out a procedure or to gain a view of the tympanic membrane this is considered as part of the overall outpatient tariff. Microsuction may be performed in primary care where a patient has one of the following contraindications to ear irrigation: The patient has previously experienced complications following this procedure. There is a history of a middle ear infection in the last six weeks. The patient has undergone ANY form of ear surgery (apart from grommets that have extruded at least 18 months previously and the patient has been discharged from the ENT Department). The patient has a perforation or there is a history of a mucous discharge in the last year. The patient has a cleft palate (repaired or not). In the presence of acute otitis externa with pain and tenderness of the pinna. Patient Information Leaflet NHS Choices Patient Information Leaflet Ear Wax Page 26 of 46

27 Mirena Coils Secondary Care OPCS Codes; Q121, Q122, Q123, Q124,Q128, Q129 Fitting of Mirena Coil for contraceptive or other purposes should only be undertaken in a primary care setting Referral to gynecology for fitting a Mirena Coil is funded only where the patient has a medical issue which prevents fitting in a primary care setting. Fitting a Mirena Coil in secondary care is funded only where it forms an integral part of the pathway for - Termination of pregnancy, or - A gynecological procedure requiring the removal of a pre-existing coil, or - Women with a medical issue preventing fitting in a primary care setting or - Where during a gynecological procedure or examination there is an indication that a Mirena coil would benefit the patient and this can be fitted during the procedure. When seeking prior approval the clinician must provide details of the medical issues that prevent fitting in a primary care setting. Page 27 of 46

28 OPCS codes Y767 - ARTHROSCOPIC APPROACH TO JOINT Z814 Shoulder Joint Shoulder Arthroscopy Shoulder arthroscopy will only be funded for patients with adhesive capsulitis ( frozen shoulder ) if the following Criteria has been met; 1. Conservative treatments, listed below, have all been tried and failed; it is the responsibility of the clinician to provide evidence to support prior approval: (a) Activity modification (b) Physiotherapy and exercise programme (c) Oral analgesics including NSAIDs (unless contraindicated) (d) Intra-articular steroid injections (e) Manipulation under anaesthetic (consider use following a fracture as undertaking manipulation under anaesthetic increases the risk of a re-fracture) 2. There are red flag symptoms If there is diagnostic uncertainty despite competent examination or if there are red flag symptoms/signs/conditions then an MRI scan might be indicated. Red flag symptoms or signs include recent trauma, constant progressive non-mechanical pain (particularly at night), previous history of cancer, long term oral steroid use, history of drug abuse or HIV, fever, being systematically unwell, recent unexplained weight loss, persistent severe restriction of joint movement, widespread neurological changes, and structural deformity. Red flag conditions include infection, carcinoma, nerve root impingement, bony fracture and avascular necrosis. The clinician must provide full details to support prior approval Page 28 of 46

29 Sleep Studies Snoring OPCS codes Greater Nottinghamshire CCGs only commission sleep studies for patients with suspected sleep apnoea, complex sleep disorders or where necessary to confirm a diagnosis of narcolepsy. Prior approval must be sought before referral for sleep studies. Snoring (defined as) loud and chronic (ongoing) Pauses may occur in the snoring. Choking or gasping may follow the pauses. Sleep apnoea (defined as) fighting sleepiness during the day, at work, or while driving witnessed breathing pauses whilst asleep If sleep apnoea is suspected patients should be referred if they have red flag symptoms or relevant comorbid conditions (see below). Those without red flag symptoms or relevant comorbid condition must meet the following criteria prior to referral to the sleep unit. Daytime sleepiness (rather than tiredness) assessed by Epworth score of 10 or above Symptoms and / or signs indicating significant sleep apnoea. Red flag symptoms: cor pulmonale respiratory failure/severe pulmonary disease vigilance critical occupations (pilots, professional drivers, operators of heavy machinery) extreme sleepiness leading to risk of danger to self or others planned general anaesthetic Relevant comorbid conditions: respiratory failure/severe pulmonary disease significant neurological or neuromuscular disease uncontrolled hypertension unstable angina/ischaemic heart disease pregnancy recent cerebrovascular disease congestive heart failure Page 29 of 46

30 Where nasal obstruction is an issue, patients should be referred for nasoendoscopic assessment of their upper airways prior to referral for sleep studies to exclude any structural cause for obstruction. Greater Nottinghamshire CCGs do not commission sleep studies for parasomnia, periodic limb movement disorder, chronic insomnia or snoring Page 30 of 46

31 Snoring ENT Referrals OPCS codes In circumstances where a cancer is suspected, the 2 week wait referral process should be used. A referral for an assessment to exclude sinister pathology will be funded when all conservative measures have been tried prior to referral. These are: Weight reduction if BMI is over 35. Use of therapies such as nasal sprays or strips. Use of ear plugs whilst asleep. Reduction of evening alcohol if relevant. Stop smoking. Self-training to alter their sleep position to avoid lying on their back. Please indicate in any referral, how the patient has altered sleep position. Use of a mandibular device (not funded by the NHS). Page 31 of 46

32 Spinal epidural injections for back pain OPCS codes: : A521, A577, A522 Funded for low back pain single injection for patients who have undergone discectomy For sciatica CCGs fund nerve root joint injection for sciatica, where; 1a. The patient has radicular pain (below the knee for lower lumbar herniation, into the anterior thigh for upper lumbar herniation) consistent with the level of spinal involvement; 1b. There is evidence of nerve-root irritation with a positive nerve-root tension sign (straight leg raise positive between 30 and 70 or positive femoral tension sign); 2. The patient is 18 years or older. 3. Symptoms persist despite non-operative treatment for at least 3 weeks (e.g. analgesia, physical therapy, bed rest etc) 4. Assessments of pain and function using the Brief Pain Inventory are documented in the patient notes at baseline prior to the first injection, and again at 6 weeks after the third injection Patients may receive up to 3 further injections (i.e. an absolute maximum of 6 injections in total) at intervals of 2-3 months provided that; The assessment of pain after the third and any subsequent injections demonstrates a reduction of at least 50% in the severity of symptoms The three final injections are provided to coincide with the patient s active participation in a comprehensive pain management programme Not funded for patients who have non-specific low back pain See Greater Nottinghamshire CCG Policy for Procedures not funded 2017 Reference NICE Clinical Guidance CG published May 2009 Page 32 of 46

33 Spinal Surgery for non-acute lumbar conditions including discectomy for lumbar disc prolapse OPCS codes: V221, V231, V241, V251, V253, V261, V333, V336, V371, V372, V373, V374, V378, V379, V381, V382, V383, V384, V388, V389, V391, V392, V393, V394, V395, V398, V399 Funding for patients to receive non-acute spinal surgery will only be made available under the following circumstance: The patient is 18 years or older The patient has had magnetic resonance imaging, showing disc herniation (protrusion, extrusion, or sequestered fragment) at a level and side corresponding to the clinical symptoms; The patient has a corresponding neurologic deficit (asymmetrical depressed reflex, decreased sensation in a dermatomal distribution, or weakness in a myotomal distribution, altered bowel or bladder function); The patient has radicular pain (below the knee for lower lumbar herniations, into the anterior thigh for upper lumbar herniations) consistent with the level of spinal involvement; MRI scan show disc herniation with compression on nerve root at a level and site corresponding to the clinical symptons; Symptoms persist despite non-operative treatment for at least 6 weeks (e.g. analgesia, physical therapy, bed rest etc.). 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. Lumbar decompression is funded for the following indication: For sciatica with nerve root compression or severe central spinal stenosis with claudication symptoms in one of both legs. Greater Nottinghamshire CCGs do not fund spinal surgery for lower back pain. Page 33 of 46

34 NHS England commissions the following and their policies can be found at the following link NHS England Guidance specialist commissioning spinal surgery 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. Patient Information Leaflet NHS Choices patient information leaflet back pain Page 34 of 46

35 Tonsillectomy OPCS codes: E201, E208, E209, F341, F342, F343, F344, F345, F346, F347, F348, F349, F361, F368, F369 Unequivocal indications for tonsillectomy: Suspected or confirmed malignancy this is an absolute indication to refer, please use the two week cancer referral. Peri-tonsillar abscess (Quinsy) Acute upper airways obstruction 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. Recurrent sore throats where the following applies (each of the episodes of tonsillitis must be documented in the patients notes and details supplied on the prior approval request form): 7 or more episodes in the last year 5 or more episodes in each of the last two years, 3 or more episodes in the last 3 years The clinician can evidence that there has been a significant and severe impact on the quality of life indicated by documented evidence of an absence from school or/and failure to thrive. Each of the episodes of tonsillitis must be documented in the patients notes, appropriately treated and characterized by at least one of the following: Oral/ aural temperature of at least 38.3 C Tender anterior cervical lymph nodes Tonsillar exudates Positive culture of group A beta haemolytic streptococci Tonsillar enlargement giving rise to symptoms of obstruction (recurrent attacks are a succession of definite episodes as opposed to chronic tonsillitis) Page 35 of 46

36 The commissioner will fund tonsillectomy in sleep apnoea syndrome in children where one or more of the following apply A positive sleep study Clinical Evidence of Adenoidal Hypertrophy Persistent Snoring Any day or night symptoms consistent with Sleep Apnoea Note the clinician must provide full evidence to support the prior approval application Rationale: Tonsillectomy offers relatively small clinical benefits compared with non-surgical treatment, measured best in terms of time off school. The benefit in the year after the operation is roughly 2.8 days less taken away from school. Tonsillectomy carries a risk of mortality estimated to lie between 1 in 8,000 and 1 in 35,000 cases. A Cochrane systemic review concluded that: There is no evidence from randomised controlled trials to guide the clinician in formulating the indications for surgery in adults or children. The frequency of sore throat episodes and upper respiratory infections reduces with time whether Adenotonsillectomy has been performed or not. References Edinburgh: SIGN guidance 34 (1999, reviewed 2005) Page 36 of 46

37 Varicose Veins OPCS Codes : : L841, L842, L843, L844, L845, L846, L848, L849, L851, L852, L853, L858, L859, L861, L862, L868, L869, L871, L872, L873, L874, L875, L876, L877, L878, L879, L881, L882, L883, L888, L889 Greater Nottinghamshire CCGs will not normally fund surgical treatment for those veins that present a largely cosmetic problem or that because simple aching that could be adequately controlled by properly measured surgical hosiery. Surgery for patients with varicose veins with the complications outlined below will continue to be funded on the NHS: venous ulceration venous eczema refractory to short term steroid cream recurrent superficial thrombophlebitis (at least two minor episodes) bleeding associated with varicose veins (at least two minor or one major bleed) post phlebitic syndrome (PTS) References 1. These criteria equate approximately to Clinical, Etiologic, Anatomic and Pathophysiologic (CEAP) stage C4 onwards or Class 4 & 5 of the Nottingham/Derby Guidelines (published 2001) Varicose Veins - who and what to treat For those patients that did not meet the policy criteria (i.e. CEAP 2-3) compression hosiery and lifestyle advice could be offered. Given the natural history of varicose veins to progress in some patients, a patient could be referred at a later date if they developed clinically so that they met the criteria. Patient information NHS Choices Patient Information Leaflet Varicose Veins Page 37 of 46

38 Vasectomy in Secondary Care OPCS Codes : N171 Vasectomies performed in a community setting do not require prior approval and should be the first choice for the procedure. Prior approval for vasectomy in secondary care is required and must demonstrate a specific medical issue which prevents the procedure being undertaken in the community. Prior approval must be sought giving full details of any medical issues. Page 38 of 46

39 Cataracts OPCS codes: C712, C751 Eligibility Criteria Retrospective Audit or Prior Approval applies Background The Commissioner will fund Cataract Surgery where there is a visual acuity of 6/12 (corrected) in the worst eye, or for: 1. Patients for whom it is vital to have good visual acuity in the worse eye for the purpose of fulfilling essential occupational responsibilities (e.g. watchmaker). 2. Patients with posterior subcapsular cataracts and those with cortical cataracts who experience problems with glare and a reduction in acuity in bright conditions 3. Driving: the legal requirement for driving falls between 6/9 and 6/12 (strictly speaking it is based on the number plate test). It is anticipated that the threshold will not render the majority of people unable to drive as it applies to the worst eye only. Exceptions to this include: * Patients who need to drive who experience significant glare which affects driving; * Patients for whom it is vital to drive at night for the purpose of fulfilling essential domestic, carer or occupational responsibilities, and who experience glare that is related to cataract; * Patients with visual field defects borderline for driving, in whom cataract extraction would be expected to significantly improve the visual field. 4. Patients with glaucoma who require cataract surgery to control intra ocular pressure 5. Patient with diabetes who require clear views of their retina to look for retinopathy Cataract Second Eye 1. Where the cataract procedure on the first eye has achieved a VA of 6/9 or better, and the VA for the second eye is 6/24 or better, then the patient should be discharged, unless receiving treatment for any other eye condition. The patient should be advised to attend an optometrist for a sight test annually or earlier if they notice any deterioration of vision. 2. If the first eye does not achieve a VA of 6/9 or better, then the second eye should be dealt with on clinical merit, taking into account any directly related essential responsibilities (i.e. the requirement for night driving). 3. There are circumstances, where despite good acuities, there may still be a clinical need to operate on the second eye fairly speedily e.g. where there is resultant anisometropia (a large refractive difference between the two eyes) which would result in poor binocular vision or even diplopia. In these circumstances, the notes should clearly record this so that it can be identified during any future clinical audit. Page 39 of 46

40 Hernia Repair OPCS codes: T251, T252, T253, T258, T259, T261, T262, T263, T264, T268, T269, T271, T272, T273, T274, T278, T279, T191, T192, T193, T198, T199, T201, T202, T203, T204, T208, T209, T211, T212, T213, T214, T218, 219,T241, T242, T243, T244, T248, T249 Eligibility Criteria Retrospective Audit or Prior Approval applies If emergency treatment is required e.g. strangulation is suspected then the referring clinician should refer the patient. All patients with femoral hernias should be referred for consultation however prior approval must be sought before surgical procedure. The surgical treatment of hernias is commissioned on a restrictive basis for patients meeting the defined criteria below. This Service Restriction Policy covers the management of; Inguinal Femoral Umbilical Incisional hernias / Ventral Criteria for referrals/treatment as below: Inguinal: For asymptomatic or minimally symptomatic hernias, a watchful waiting approach is advocated with 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 (e.g. removal firms lifting heavy weights) and there is an increased risk of strangulation and future complications. Page 40 of 46

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