Procedures of Limited Clinical Effectiveness policy

Transcription

1 Procedures of Limited Clinical Effectiveness policy Introduction This document is the Procedures of Limited Clinical Effectiveness (POLCE) policy for Barking and Dagenham, Havering and Redbridge Clinical Commissioning Groups (BHR CCGs). The policy is arranged in two sections: Section 1 lists procedures which are not routinely funded by the CCGs. Clinicians wishing to refer patients for any of these procedures should submit an Individual Funding Request application form. The application should describe the clinical evidence base describing the clinical effectiveness of the proposed intervention together with and explanation of the clinical exceptionality of the patient how the patient s clinical presentation is different to other patients with the same condition or wanting the same intervention such that the patient should receive NHS funding which is not routinely available to all other patients. Section 2 lists procedures which the CCGs will only fund if the applicant clinician can clearly demonstrate that the patient meets all the clinical criteria described in the policy. Clinicians are required to seek Prior Approval before referring or treating a patient for a procedure listed in Section 2. Clinicians seeking Prior Approval should complete the relevant Tick Box Form for the specific procedure For information about the Individual Funding Request (IFR) or Prior Approval processes including application forms and Tick Box Forms please contact Individual Funding Requests team NEL Commissioning Support Unit Second Floor, Clifton House Worship Street London, EC2A 2DU Telephone: nelcsubhr-ifr@nhs.net 1

2 SECTION 1: List of not routinely funded interventions BHR CCGs will not routinely fund the following interventions: Intervention Breast Augmentation Revision of breast augmentation Face lifts and brow lifts (rhytidectomy) Cosmetic genital procedures (Labiaplasty) Varicose veins Treatment for varicocoele Trigger finger Sympathectomy for severe hyperhidrosis (palmar, plantar, axillary) Liposuction Tattoo removal Autologous chrondocyte (cartilage) implantation Occipital nerve stimulation for cluster headache Laser surgery for short sightedness Sacral nerve stimulation for faecal and urinary incontinence Homeopathy Acupuncture and osteopathy Status 2

3 Ketogenic diet for epilepsy Breast lift (mastopexy) Treatment of vascular lesions Hair transplantation Cholecystectomy for asymptomatic gall stones Spinal injections injections to the intervertebral discs facet joint injections epidural injections for spinal claudication (BHR CCGs do routinely fund Medial branch blocks, Medial branch radiofrequency lesioning and Transforaminal epidural steroid injection/dorsal root ganglion pulsed radiofrequency) Uterine fibroids Reverse sterilisation Surgical interventions for snoring Continuous glucose monitoring for type 1 diabetes White cell apheresis Clinicians wishing refer patients for any of the procedures listed above should submit an Individual Funding Request (IFR) application form. IFR applications are assessed on a range of factors including clinical effectiveness and clinical exceptionality. Any IFR application for these procedures should therefore describe the clinical evidence base supporting the intervention should clearly explain why the patient s clinical presentation is different to all the other patients who may want the intervention such that they should be funded when others are not. IFR applications should be submitted via secure (nhs.net) to: nelcsubhr-ifr@nhs.net 3

4 Section 2 Interventions requiring Prior Approval BHR CCGs will only fund the following interventions where it can be clearly demonstrated that the patient meets the listed clinical criteria. Clinicians wishing to refer or treat patients for any of the following procedures should complete a Tick Box Form (TBF) to demonstrate how the patient meets the clinical criteria. The TBF should ordinarily be completed in advance of any treatment. For primary care referrals, clinicians should submit using the NHS Digital e-referral Service (e-rs). Referrals from secondary care should be submitted via secure (nhs.net) to: nelcsubhr-ifr@nhs.net 4

5 1. Female breast reduction and correction of breast asymmetry Bilateral breast reduction surgery is not routinely funded by BHR CCGs. N.B. This breast reduction policy is not applicable to the removal of symptomatic accessory breast tissue, which is routinely commissioned by the CCGs. With prior approval, funding may be considered by BHR CCGs where all the criteria below are met and evidenced: 1. the patient s breast size is cup size H or larger 2. the breast reduction surgery should result in a reduction in breast size of at least three cup sizes*/ 500gm per side 3. the patient has a BMI equal to or below 27 kg/m2 for at least two years (documented). 4. evidence to be submitted to demonstrate patient is symptomatic with at least two of the following for at least one year (documented evidence of GP visits for these problems): pain in the neck pain in the upper back pain in the shoulders painful kyphosis documented by X-rays pain / discomfort / ulceration from bra straps cutting into shoulders 5. Evidence to be submitted to demonstrate pain symptoms persist as documented by the physician despite a six month trial of therapeutic measures including all of the following: supportive devices (e.g., proper bra/support bra fitted by a trained bra fitter, wide bra straps) analgesic / non-steroidal anti-inflammatory drugs (NSAIDs) interventions physical therapy / exercises / posturing manoeuvres 6. there are significant muskulo-skeletal pain or symptoms that are causing significant functional impairment which in the opinion of the referrer (in the opinion of an appropriate specialist) are likely to be corrected or significantly improved by surgery Chronic intertrigo, eczema or dermatitis alone will not be considered as grounds for this procedure unless the entire above are met and the patient has failed to respond to six months of conservative treatment. 5

6 Correction of breast asymmetry is not routinely funded by BHR CCGs. With prior approval, funding for unilateral breast reduction (not augmentation) may be considered by BHR CCGs where all the criteria below are met and evidenced: 1. where there is gross asymmetry (difference in size a minimum three cup* sizes) 2. where there is no ability to maintain a normal breast shape using non-surgical methods (e.g. padded bra) 3. the woman s breasts are fully developed i.e. there has been no change in the size of either breast over the previous 18 months 4. the woman is aged over 18 years *Cup sizing - AA, A, B, C, D, DD, E, F, FF, G, GG, H, HH, J, JJ, K, L 2. Male breast reduction This procedure is not routinely funded by BHR CCGs. With prior approval, funding for male breast reduction may be considered by BHR CCGs where all the criteria below are met and evidenced: 1. the applicant demonstrates that they have screened for and excluded all treatable causes of gynaecomastia (drug related; particularly abuse of anabolic steroids, endocrine) 2. the patient is both post pubertal and in the case of idiopathic gynaecomastia has had this for at least 18 months (to allow spontaneous resolution) 3. gynaecomastia is causing pain unrelieved by standard analgesia 4. the patient has a BMI of less than 27 kg/m2 6

7 5. a consultant surgeon has confirmed that the patient has grade III gynaecomastia (i.e. gross breast enlargement with skin redundancy and ptosis so as to simulate a pendulous female breast) the proposed reduction is greater than 100gm per side 6. the patient is aged 25 years or older Additional information: Gynaecomastia is commonly seen during puberty and may correct once the post pubertal fat distribution is complete if the patient has a normal BMI. It may be unilateral or bilateral. Rarely, it may be caused by an underlying endocrine abnormality or a drug related cause including the abuse of anabolic steroids. It is important that male breast cancer is not mistaken for gynaecomastia and, if there is any doubt, an urgent consultation with an appropriate specialist should be obtained. 3. Abdominoplasty and excess skin excision Abdominoplasty and other excess skin excision surgery including buttock, thigh and arm lifts are not routinely funded by BHR CCGs. With prior approval, funding for abdominoplasty will be considered by BHR CCGs for patients who meet both criteria 1 and 2 below plus one of criteria 3a-c. 1. following weight loss have a stable BMI of less than 27 Kg/m2 for at least 24 months 2. in the case of bariatric surgery, had their surgery at least two years previously 3. have severe functional problems from excessive abdominal skin folds as defined as: a) severe difficulties with daily living (i.e. walking, dressing, toileting) which have been formally assessed, and for which abdominoplasty will provide a clear resolution b) documented evidence of clinical pathology due to the excess of overlying skin e.g. recurrent infections or intertrigo which has led to ulceration requiring four or more courses of antibiotics in the 7

8 24 month period of stable weight c) where overhanging skin makes it impossible to maintain care of stoma bags BHR CCGs do not routinely commission surgery to correct divarification (or diastasis) of the rectus abdominis muscles irrespective of whether additional abdominoplasty is requested because there is no good evidence that this surgery is anything other than cosmetic. 4. Excision of skin and subcutaneous lesions Excision of skin and subcutaneous lesions are not routinely funded by BHR CCGs. A patient with a skin or subcutaneous lesion that has features suspicious of malignancy must be referred to an appropriate specialist for urgent assessment. Benign skin lesions may occasionally be excised for a differential diagnosis. Clinically benign moles should not be referred for cosmetic reasons. Suspicious pigmented lesions should always be subjected to excision biopsy and sent for histology, if referred to secondary care this should be to a pigmented lesions clinic. With prior approval, funding will be considered for all other benign skin lesions for patients who meet both criteria 1(a) and 1(b), or one of criteria 2 or 3 1a) the lesion is unavoidably and significantly traumatised on a regular basis 1b) associated trauma results in significant infections such that the patient requires two or more courses of oral or intravenous antibiotics per year 2. the lesion is obstructing an orifice or impairing field vision 3. the lesion significantly impacts on function e.g. restricts joint movement by >20 degrees 8

9 5. Keloid scar revision BHR CCGs will not fund surgical procedures to re-fashion keloid scars for cosmetic purposes. With prior approval, the treatment of symptomatic keloid scars may be funded by BHR CCGs if the scar: interferes with physical function causes pain or itchiness for six months and as unrelieved by standard medication Corticosteroid injections and Haelan tape should be considered the first line treatment for keloid scars. The aim of injections and tape is to improve the appearance of the scar. Patients should be informed of the need to wear the tape for 12 hours daily for at least 3 months. Patients should be informed that having surgery on a scar will in itself leave a new scar that will take up to two years to improve in appearance. If surgery is used to treat a hypertrophic scar, there is a risk that the scarring may be worse after the surgery. Low-dose, superficial radiotherapy may reduce the recurrence rate of hypertrophic and keloid scars after surgery. Because of the possibility of long-term side effects, it is only reserved for the most serious cases. IFR applications should be submitted for this intervention describing the clinical exceptionality in any case. 6. Pinnaplasty or otoplasty BHR CCGs will commission surgical correction of prominent ear(s) only when all of the following criteria are met: 1. referral only for children aged five to 18 years at the time of referral 2. with very significant ear deformity or asymmetry demonstrated by clinical photography Patients not meeting these criteria should not be routinely referred for surgery. Applications made on the basis of disfigurement should be supported by high quality clinical photography. 9

10 Due to the need for clinical review of photographs, all applications for pinnaplasty procedure will be treated as an Individual Funding Request. 7. Botulinum toxin BHR CCGs will not fund the use of Botulinum Toxin for cosmetic treatments. Botulinum Toxin applications in oculoplastics With prior approval, BHR CCGs will fund the use Botulinum A by an oculoplastics specialist in the following circumstances: Entropion Botox will be commissioned by BHR CCGs for patients with INVOLUTIONAL entropion who meet one of the following criteria: have a corneal ulcer/keratopathy secondary to entropion where surgery is contraindicated due to medical co-morbidities not warranting cessation of anticoagulation patient with advanced dementia, who is not fit for surgery under local, with or without sedation or general anaesthesia Corneal Ulcer/lagophthalmos Botox will be commissioned by BHR CCGs for patients with corneal ulcer/ lagophthalmos who: have a corneal ulcer due to facial palsy and lagophthalmos to induce a protective ptosis have a corneal ulcer due to lagophthalmos secondary to eyelid retraction, trauma or proptosis to induce a protective ptosis Botox treatment may need to be repeated after three to six months. 10

11 Blepharospasm Botulinum A toxin is routinely funded and does not require prior approval for the treatment of blepharospasm. For palmar or plantar hyperhidrosis, other procedures such as iontophoresis appear to be more effective and have fewer side effects and should be considered as initial treatment. Botulinum A toxin is routinely funded and does not require prior approval for: 1. spasticity, hand and wrist disability associated with stroke, hemofacial spasm, spasmodic torticollis 2. severe hyperhidrosis, overactive bladder syndrome Botulinum B toxin is routinely funded and does not require prior approval for: 1. spasmodic torticollis 2. as alternative to Botulinum toxin A in presence of antibodies to Botulinum A. Botulinum A will also be approved for treatment of migraine for patients who meet the criteria described in NICE TA 260: 1.1 Botulinum toxin type A is recommended as an option for the prophylaxis of headaches in adults with chronic migraine (defined as headaches on at least 15 days per month of which at least eight days are with migraine) that has not responded to at least three prior pharmacological prophylaxis therapies and whose condition is appropriately managed for medication overuse. Botox treatment needs to be repeated after six to nine months. 1.2 Treatment with botulinum toxin type A that is recommended according to 1.1 should be stopped in people whose condition: is not adequately responding to treatment (defined as less than a 30% reduction in headache days per month after two treatment cycles) or has changed to episodic migraine (defined as fewer than 15 headache days per month) for three consecutive months. 11

12 8. Hair epilation (hair removal by electrolysis or laser) Hair epilation (hair removal by electrolysis or laser) is not routinely funded by BHR CCGs. Funding for hair epilation may be approved by the IFR panel for patients who: have undergone reconstructive surgery leading to abnormally located hair-bearing skin to the face, neck or upper chest (areas not covered by normal clothing) are undergoing treatment for pilonidal sinuses to reduce recurrence For patients who do not meet these criteria, an IFR application will ONLY be considered (for facial, neck or upper chest areas not covered by normal clothing) on completion of the relevant section explaining for the benefit of the IFR panel why the patient differs from the cohort of similarly hirsute patients such that they are likely to gain more health benefit from depilation which is not available to other similar patients. Patients undergoing gender reassignment procedures will be assessed in accordance with this policy as it applies to a natural born male or female, as appropriate. An IFR application would need to be submitted in this context explaining precisely why the transgender person is likely to gain significantly greater health benefit than other patients for whom the same procedures are not funded. In the event that NHS funding is agreed it will be for a maximum of six treatments. By including this statement we are implying we will fund a trial of treatment and it could be contradictory to the paragraph below. Because BHR CCGs do not fund maintenance treatment for hirsuitism, it is not considered appropriate to commission an intervention whose effects are likely to be transitory and psychological distress would be likely to recur. Severe hirsutism due to an endocrine disorder may be referred to an endocrinology department but this is not an indication for NHS funding of epilation. 12

13 This policy does not cover the treatment of symptomatic trichiasis, which is funded by BHR CCGs. 9. Nipple inversion Nipple inversion may occur as a result of an underlying breast malignancy and it is essential that this be excluded. With prior approval, surgical correction of nipple inversion will be funded by BHR CCGs only for functional reasons in a post- pubertal woman where: the inversion has not been corrected by correct use of a non-invasive suction device Additional information: Idiopathic nipple inversion may be corrected by the application of sustained suction. Commercially available devices are available from major chemists or online without prescription. Best results are seen where this is used correctly for up to three months. 10. Treatment for hair loss BHR CCGs will not routinely fund alternative interventions for hair loss, including but not limited to: o hair grafting and flaps with/ without tissue expansion o non-nhs provided Interlace system o alternative, non-nhs wigs The standard management of significant hair loss is the NHS funded provision of a limited range of wigs. Funding for treatment may be approved by the IFR panel when the alopecia is a result of previous surgery or trauma including burns where there is sufficient evidence to demonstrate to the IFR panel that: the intervention is clinically necessary rather than cosmetic 13

14 the intervention is likely to be clinically effective in the context of the patient s previous surgery or trauma Additional information: Male pattern baldness is a normal process for many men at whatever age it occurs and affects significant numbers of women. 11. Rhinoplasty Rhinoplasty is not routinely funded by BHR CCGs. With prior approval, requests for rhinoplasty will be approved by BHR CCGs for patients with: demonstrable obstruction of the nasal airway significant symptoms confirmed by an ENT consultant as resulting from nasal obstruction symptoms that persist despite at least three months of conservative management with, where appropriate, nasal steroids or immunotherapy Additional information: Correction of complex congenital conditions e.g. cleft lip and palate is commissioned by NHS England 12. Surgery on the upper or lower eyelid (blepharoplasty) This procedure is not routinely funded by BHR CCGs. With prior approval, requests for surgery on the upper or lower eyelid (blepharoplasty) will be considered for funding by BHR CCGs to correct: impairment of visual field(s) in the relaxed, non-compensated state supported by visual field test demonstrating that eyelids impinge on visual fields reducing them to laterally and 40 0 vertically clinical observation of poor eyelid function, discomfort, e.g. headache worsening towards end of day and / or evidence of chronic compensation through elevation of the brow 14

15 significant ectropion or entropion that requires correction Additional information: Excessive skin in the lower lid may cause eyebags but does not affect eyelid function or vision and therefore does not need correction. 13. Double balloon enteroscopy BHR CCGs will not routinely fund double balloon enteroscopy (DBE) for diagnostic purposes. BHR CCGs will not routinely fund DBE for therapeutic interventions, but in some cases where alternative interventions have been exhausted (including but not limited to wireless capsule endoscopy, radiological imaging, the patient is symptomatic, and surgical first line therapy is not suitable) an IFR application may be considered if submitted by the acute trust gastro-intestinal MDT. 14. Abdominal wall hernia management and repair 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, the commissioner advocates a watchful waiting approach including providing reassurance, pain management etc. under informed consent. With prior approval, BHR CCG will fund surgical treatment when one of the following criteria is met: symptomatic i.e. significant symptoms that interfere with activities of daily living or the ability to work the hernia is difficult or impossible to reduce history of incarceration 15

16 inguino-scrotal hernia increases in size month on month Umbilical: With prior approval, BHR CCG will fund surgical treatment will when one of the following criteria is met: significant symptoms that interfere with activities of daily living or the ability to work increase in size month on month to avoid incarceration or strangulation of bowel Incisional: With prior approval, BHR CCG will fund surgical treatment will when both of the following criteria are met: significant symptoms that interfere with activities of daily living or the ability to work appropriate conservative management has been tried first e.g. weight reduction where appropriate Femoral: All suspected femoral hernias are approved for a referral to secondary care due to the increased risk of incarceration/strangulation and do not require prior approval to be sought. Impalpable hernia and groin pain Patients with groin pain and occult hernia (without clinical evidence of hernia) should be offered watchful waiting for their hernia. 16

17 15. Haemorrhoidectomy With prior approval, BHR CCGs will fund haemorrhoidectomy for 3rd degree and 4th degree haemorrhoids for patients who meet criteria 1 and one of criteria 2a-c. 1. Conservative treatment has failed: diet modification to relieve constipation topical applications stool softeners and laxatives rubber band ligation sclerosant injections infrared coagulation 2a) haemorrhoids are recurrent 2b) there is persistent bleeding 2c) haemorrhoids cannot be reduced Surgical treatment options include: o surgical excision (haemorrhoidectomy) o stapled haemorrhoidopexy o haemorrhoidal artery ligation NB: this policy does not apply to referrals for suspected cancer and acute, profuse rectal bleeding. 17

18 16. Circumcision BHR CCGs will not routinely fund non-medical circumcision. With prior approval, BHR CCGs will funding circumcision for medical indications: phimosis seriously interfering with urine flow and/or associated with recurrent infection paraphimosis suspected cancer or balanitis obliterans congenital urological abnormalities when skin is required for grafting and interference with normal sexual activity in adult males recurrent, significantly troublesome episodes of infection beneath the foreskin to restore functional anatomy after female circumcision to facilitate childbirth where mutilation renders this hazardous Female circumcision (Female Genital Mutilation) is prohibited under the Prohibition of Female Circumcision Act

19 17. Surgical excision of ganglia BHR CCGs will not routinely fund surgical excision of ganglia. With prior approval, surgical excision of ganglia will only be considered by BHR CCGs when one of the following criteria is met: 1. painful seed ganglia 2. mucoid cysts arising at the distal inter-phalangeal joint and cause significant skin breakdown, significant nail deformity or repeatedly discharge 3. cause significant functional impairment and/or pain is unrelieved by aspiration or injection 4. where there is diagnostic uncertainty Additional information: Patients should be re-assured about the benign nature of other ganglia and be informed that: 33% of dorsal ganglions and 45% of volar-wrist ganglia would resolve spontaneously in six years the recurrence rate after excision of wrist ganglia is between 10 45% 18. Dupuytren s contracture With prior approval, BHR CCGs will fund surgical treatment when criteria 1 and one of criteria 2(a) or 2(b) are met : 1. the patient has a 30 degree fixed flexion deformity at either the metacarpophalanageal joint or proximal interphalangeal joint 2a) the patient cannot flatten their fingers or palm on a table 19

20 2 b) there has been rapid progression over a few months 19. Functional electrical stimulation (FES) for footdrop Based on the evidence of clinical and cost effectiveness provided, FES is not routinely commissioned by BHR CCGs. With prior approval, funding for patients with ongoing funding for maintenance and support will be considered by BHR CCGs where the following criteria is met: The patient will have objectively demonstrated that the use of FES is still clinically appropriate by: a) foot drop which impedes gait and evidence that this is not satisfactorily controlled using ankle-foot orthosis b) gait improvement from its use 20. Exogen bone healing With prior approval, BHR CCGs will fund the use of the EXOGEN ultrasound bone healing system to treat long bone fractures with non-union only (failure to heal after 9 months) NICE Guidance MTG12: EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing 21. Spinal surgery With prior approval, BHR CCGs will fund spinal surgery when criteria 1 and one of criteria 2(a) or 2(b) are met: 1. discectomy for lumbar disc prolapse in patients >18 years, who have MRI disc herniation at level and side corresponding to clinical symptoms 20

21 2a) demonstrable neurological deficit 2b) radicular pain despite conservative therapy under the care of a specialist back pain MDT for at least six weeks fusion only where there is unequivocal root compression, spinal stenosis, instability and failure of conservative management for >six months severe spinal stenosis with symptoms of neurogenic claudication and the MRI confirms significant caudal stenosis (NICE IPG 365) 22. Hip arthroscopy Open or arthroscopic femero-acetabular surgery for hip impingement is funded with prior approval by BHR CCGs if the indications are clearly specified and where all of the following criteria are met: labral tear or impingement has been confirmed on MRI where hip arthroscopy is supported in the washout of an infected native hip joint in patients refractory to medical management, patients with underlying disease or patients who are immunosuppressed where 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 the clinician has ensured that the patient understands what is involved, is aware of the serious known complications outlined in NICE patient information and agrees to the treatment knowing that there is only evidence of symptom relief in the short and medium term the surgeon must have completed specialist training and have experience of providing arthroscopic hip surgery the provider will provide full data on100% patients undergoing this procedure to the British Hip Society register (currently being established to support assessment of long term outcomes) the provider will undertake local review of cases to monitor safety and short term outcomes 21

22 Hip resurfacing BHR CCGs will fund for those 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). 23. Joint replacement surgery (hip or knee replacement) With prior approval, BHR CCGs will fund joint surgery where all of the following criteria are met: osteoarthritis with joint symptoms (pain, stiffness and reduced function) that have a substantial impact on quality of life as agreed with the patient and or the patient s representative, referring clinicians and surgeons the symptoms are refractory to non-surgical treatment. there is evidence that conservative means have failed to alleviate pain and disability the prosthesis used are standard 24. Knee washout for osteoarthritis BHR CCGs will not routinely fund knee washout for osteoarthritis. With prior approval, funding requests for arthroscopic lavage and debridement should only be considered in the few patients for patients who meet all of the following criteria: knee osteoarthritis a clear history of mechanical locking i.e. true locking, not gelling, 'giving way' or X-ray evidence of loose bodies 22

23 25. Bunion surgery (Hallax Valgas) With prior approval, BHR CCGs will fund bunion surgery where one of the following criteria are met: 1. significant pain on walking not relieved by chronic standard analgesia 2. deformity such that fitting adequate footwear is difficult 3. overlapping or underlapping of adjacent toe(s) 4. hammer toes 5. recurrent or chronic ulceration 6. bursitis or tendinitis of the first metatarsal head 26. Bartholin s cysts With prior approval, BHR CCGs will fund the surgical treatment of Bartholin s cysts which cause: significant pain have become infected requiring anti-biotic treatment on at least two separate occasions 27. Elective caesarean With prior approval, BHR CCGs will fund a planned Caesarean section in any of the following circumstances: with a singleton breech presentation at term, for whom external cephalic version is contraindicated or has been unsuccessful 23

24 in twin pregnancies where the first twin is breach HIV+ mothers who are not receiving any anti-retroviral therapy or are receiving any anti-retroviral therapy and have a viral load of 400 copies per ml or more mother with both hepatitis C virus and HIV with primary genital herpes simplex virus (HSV) infection occurring in the third trimester of pregnancy a placenta that partly or completely covers the internal cervical os (minor or major placenta praevia) a previous caesarean section where it is clinically indicated A planned Caesarean Section should NOT be routinely offered to women: with an uncomplicated twin pregnancy at term where the presentation of the first twin is cephalic with a 'small for gestational age' baby on the grounds of HIV status to prevent mother-to-child transmission of HIV to women on highly active anti- retroviral therapy (HAART) with a viral load of less than 400 copies per ml or women on any antiretroviral therapy with a viral load of less than 50 copies per ml. with hepatitis B with hepatitis C with a recurrence of genital herpes simplex virus (HSV) at birth with a body mass index (BMI) of over 50 alone as an indicator This is in line with the updated NICE 2012 guidance on Caesarean Section 28. Hysterectomy for menorrhagia (heavy menstrual bleeding) This procedure is not routinely funded by the BHR CCGs. Hysterectomy should not be used as a first-line treatment solely for heavy menstrual bleeding With prior approval, hysterectomy for menorrhagia will be considered by BHR CCGs where the criteria below are met and evidenced: 1. The patient has been managed medically for 3-6 months and trialled any two of the drugs from the list below without benefit: o Tranexamic acid o Non-steroidal anti-inflammatory drugs (NSAIDs) o Combined oral contraceptives 24

25 o Oral progesterone o Injected progesterone 2a) There has been an unsuccessful trial (of at least six cycles) with a levonorgestrel intrauterine system (e.g Mirena ) unless medically contraindicated 2b) the patient has refused a trial of a levonorgestral intrauterine system (criterion 2 above) and endometrial ablation has been trialled Before surgery is considered patients should be offered endometrial ablation if steps 1 and 2 above have failed to control symptoms. Endometrial ablation is a compulsory step prior to surgery for any patient who has refused 2(a) above. NICE guidance: Tonsillectomy This procedure is not routinely funded by the BHR CCGs for adults or children. With prior approval, BHR CCGs will considered funding tonsillectomy where one of the criteria below are met and evidenced: suspected malignancy significant impact on quality of life resulting from documented recurrent acute tonsillitis (patients or parents should keep a diary to verify this) comprising: o seven or more episodes of tonsillitis in the preceding year o five episodes/year in each of the preceding two years An eligible episode must have three of the following features: tonsillar exudates tender anterior cervical lymph nodes history of fever absence of cough over a 24 hour period 25

26 documented evidence of absence from playgroup, school or work (children) failure to thrive (children) adults with proven recurrent group A streptococcal pharyngitis (GAHSP) documented evidence of two or more episodes of tonsillitis or quinsy requiring admission to hospital tonsillitis exacerbating existing disease such as febrile convulsions, guttate psoriasis, glomerulonephritis or rheumatic fever With prior approval, BHR CCGs will consider tonsillectomy specifically to address sleep apnoea syndrome in children who meet criteria 1 or both criteria 2(a) and 2(b) below: 1. Witnessed episodes or apnoea exceeding 10 seconds 2(a) Choking episodes during sleep 2(b) Daytime neuro- behavioural abnormalities or excessive sleepiness Tonsillectomy is not funded for adults with snoring or obstructive sleep apnoea (based on limited evidence of effectiveness) 26

27 30. Grommet(s) This procedure is not routinely funded by the BHR CCGs. With prior approval, BHR CCGs will consider funding where one of the following criteria are met: criteria 1 (including all sections: a, b, and c) or criteria 2 (including all sections: a, b, and c) or criteria 3 to 6: 1a) children between the ages of three and 12 years who have documented, persistent, bilateral otitis media with effusion (OME) 1b)documented persistent hearing loss on two occasions at intervals of three months or more 1c) hearing in the better ear of dbhl or less averaged at 0.5, 1, 2 and 4 khz 2a) children between the ages of three and 12 years who have documented, persistent otitis media with effusion (OME) 2b) documented persistent hearing loss on two occasions at intervals of three months or more 2c) hearing loss suggestive of additional sensori-neural deafness 3. evidenced delay in speech development significant educational, social or behavioural problems attributable to persistent hearing impairment a hearing level of dbhl or less 4. a second disability (e.g. Down s syndrome) 5. the otoscopic features are atypical and accompanied by a foul-smelling discharge suggestive of cholesteatoma 6. five or more episodes of acute otitis media 27

28 Insertion of ventilation tubes for patients of any age may be indicated as a component of tympanic membrane repair or to preserve function. Additional information: surgery may resolve glue ear in the short term but there is less certainty about longer term outcomes and large variation in effect between children there is debate about how best to select children for intervention, given the high rate of resolution particularly in younger children a period of watchful waiting is widely recognized as good practice because timing of surgery is not critical to medium term outcome Grommets and adenoidectomy represent a trade-off between benefits and harms; adenoidectomy on its own is of unknown effectiveness Evidence base: Current NICE Guidance 31. Ear wax removal via aural microsuction This procedure is not routinely funded by the BHR CCGs. With prior approval, BHR CCGs will fund ear wax removal via aural microsuction for: people who have had ear surgery (including grommets) people who have had a perforated ear drum people with severe inflammation of the ear canal people with a repaired or existing cleft palate People with Keratosis Obturans People with presence of congenital ear canal atresia 28

29 People with previous head and neck radiotherapy People with Cranio-facial deformity - such as Down's Syndrome, Treacher Collins syndrome. 32. Surgical treatment of chronic sinusitis ENT referral is appropriate for suspected: complications, e.g. periorbital infection suspected sinonasal tumour Surgical treatment of chronic sinusitis is not routinely funded by the BHR CCGs and will only be considered for funding, with prior approval, where all of the following criteria are met: recurrent or chronic sinusitis of uncertain cause unremitting or progressive facial pain a trial of intranasal corticosteroids of three months in duration has been ineffective a significant anatomical abnormality Additional Information: Evidence Base: NHS Clinical Knowledge Summaries advise a trial of intranasal corticosteroids for three months for treatment in the first instance. Sinus puncture and irrigation has a poor diagnostic yield, and carries the risk of secondary contamination. Only short-term benefit seen in patient refractory to medical management treated with balloon catheter dilation of sinus ostia. 29

30 33. Cataract This procedure is not routinely funded by the BHR CCGs for adults or children. With prior approval, BHR CCGs will consider funding where one of the criteria below are met and evidenced: 1. the patient s visual acuity is 6/12 or worse in the affected eye and visual problems mean reduced mobility, experiencing difficulties in driving, for example, due to glare, or experiencing difficulty with steps or uneven ground 2. the patient has one of the following clinical indications: o the patient s ability to work, give care or live independently is affected. o if the patient has diabetes, or a retinal condition, which requires clear views of your retina to monitor the disease or treatment. o if the patient has had glaucoma which requires cataract surgery to control the eye s fluid pressure (intra ocular) o if the patient has a certain type of cataract (posterior subcapsular or cortical) and experience problems with glare and a reduction in acuity in bright conditions o the patient s vision makes it borderline whether you should drive, and surgery would be expected to significantly improve your vision If the patient has two cataracts (cataracts in both eyes), cataract surgery in the second eye would only be funded, with prior approval, if one of the following criteria is met: the first cataract surgery does not achieve a visual acuity of 6/9 or better, with refractive correction, and the procedure is clinically indicated for the patient's individual circumstances the patient has diabetes, or retinal condition, which requires clear views of their retina to monitor their disease the patient is left with anisometropia or any condition meaning that binocular vision is not comfortable 30

31 34. Open MRI Open MRI is not routinely funded by the BHR CCGs. Severely obese patients should be referred by a secondary care clinician to the bariatric MRI service at Barts Health. Claustrophobic patients should be referred to the special Sunday MRI service for claustrophobic patients at BHRUT. An IFR request may be made for claustrophobic patients who have attended the BHRUT special service but are still unable to proceed with a scan. For these patients the referrer will be expected to: identify the service they wish to refer the patient too state why no other diagnostic tests are suitable state how the MRI would affect decisions about the patient s treatment 35. Bariatric surgery Bariatric surgery is not routinely funded by BHR CCGs. With prior approval, BHR CCGs will consider funding this intervention only if the patient meets all of the clinical criteria outlined below: patients who have been diagnosed with Type 2 Diabetes have a BMI of 35 kg/m² and above are eligible 31

32 36. Podiatry Podiatry services are not routinely funded by BHR CCGs. With prior approval, BHR CCGs will only fund routine podiatry services if the patient meets one the criteria below: over the age of 65 who have a clinical need for treatment with an underlying medical condition under the age of 16 (excluding treatment for verrucae) learning difficulties (including mental health disorders) medical conditions that may affect their foot health e.g. diabetes physical disability BHR CCGs will routinely fund the following podiatry services which do not require prior approval: o biomechanical and gait reviews o nail surgery for painful/in-growing toenails (under local anaesthetic) o a comprehensive diabetic foot service, including the management of acute foot problems 32

33 Contents 1a. Female breast reduction Page Bunion surgery (Hallax Valgas) Page 23 1b. Correction of breast asymmetry Page Bartholin s cysts Page Male breast reduction Page Elective caesarean Page Abdominoplasty and excess skin excision Page Hysterectomy for menorrhagia (heavy Page 224 menstrual bleeding) 4. Excision of skin and subcutaneous lesions Page Tonsillectomy Page Keloid scar revision Page Grommet Page Pinnaplasty or otoplasty Page Ear wax removal via aural microsuction Page Botulinum toxin Page Surgical treatment of chronic sinusitis Page Hair epilation (hair removal by electrolysis or laser) Page Cataract Page Nipple inversion Page Open MRI Page Treatment for hair loss Page Bariatric Surgery Page Rhinoplasty Page Podiatry Page Surgery on the upper or lower eyelid Page 14 (blepharoplasty 13. Double balloon enteroscopy Page Abdominal wall hernia management and repair Page Haemorrhoidectomy Page Circumcision Page 18 33

34 17. Surgical excision of ganglia Page Dupuytren s Contracture Page Functional electrical stimulation (FES) for footdrop Page Exogen bone healing Page Spinal surgery Page Hip Arthroscopy Page Joint replacement surgery (hip or knee Page 22 replacement) 24. Knee washout for Osteoarthritis Page 22 34