PROCEDURES OF LIMITED CLINICAL VALUE POLICY (PLCV) Version 25a April Based on OPCS 4.6 and ICD 10

Transcription

1 PROCEDURES OF LIMITED CLINICAL VALUE POLICY (PLCV) Version 25a April 2016 Based on OPCS 4.6 and ICD 10 1

2 Version Control Version Comments Version 1 - October 2011 Drafted from Hereford policy papers following agreement to proceed from Clinical Advisory Panel and Joint Committee on Priorities and Policies. February 2012 Final comments received from Shrewsbury and Telford Hospital (SaTH). Version 2 February 2012 Amended with received comments and included current policies. Version 3 March 2012 Amended to include current aesthetics policies. Removed Initial Draft from Watermark and replaced with Final Draft. Removed references to NHS Telford and Wrekin. Submitted for Clinical Advisory Panel meeting on March 14 th Version 4 6 th March 2012 Amended to include comments received from dental adviser s changes to dental implants and formatting of the policy. Version 5 6 th March 2012 Amended per Su Green comments. Version 6 7 th March 2012 Amended per Su Green further amendments (v3). Version 7 7 th March 2012 Final amendments to layout. Version 8 26 th March 2012 Comments from Clinical Advisory Panel inserted and amendments following comments from Robert Jones and Agnes Hunt Hospital. Version 9 17 th April 2012 Adopted by CCG Board Meeting 4 th April 2012 subject to HoSC meeting to be held on 28 th May Version th April 2012 Amendments made following Dr Povey meeting with Mr Fox (SaTH). Formatting changed to version control sheet and text within in section 9. Version 10a 30 th April 2012 Amendments following Dr Povey review Dr to Mr on version control sheet and addition on page 14. Version 10b 9 th May 2012 Amendments to Section 4.8 as per RJaH letter dated 19 th April Version th July 2012 Breast asymmetry omitted and replaced back into document. Formatting of document and table of contents. Version th September 2012 Blepharoplasty Surgery Text added in Documented clinical observation of poor eyelid function leading to discomfort, e.g. headache worsening towards end of day and/or evidence of chronic compensation through elevation of the brow. Formatting of table of contents re-numbering of section 9 and page numbers. Version th October 2012 Document split into categories for GP ease of reference. Version nd October 2012 Version 15 3 rd December 2012 Version th January 2014 Version th July 2014 Version 18 6 th August 2014 Version th August 2014 Abbreviations added for ease of reference and referring headings changed within the document. Amendments made as per s from Su Green & Dr J Povey November/December Inserted CCG logo and updated IFR policy web link to: replaced wording from Shropshire County PCT to Shropshire Clinical Commissioning Group and Shropshire PCT to SCCG. Whole document review post further evidence and comparison between current policy and NHS England policies for Armed Forces Commissioning, and discussion at JCPAC Meetings. Policy as agreed by CAP with exclusions and inclusions. Final amendments to layout Version th December 2014 Version 21-5 th March 2015 Version th March 2015 Version th March 2015 Version th March 2015 Version 25 1 st April 2015 Version 25a 1 March 2016 TWCCG logo added to joint CCG policy. Policy updated as per meeting with Carol McInnes and SClennell Latest updates added throughout inc changes from Wendy Southall, Carol McInnes, Sharon Clennell and Claire Roberts Updates to sections and Intro s from Sharon Clennell, Wendy Southall and Darren Francis Updates to Cataract and Ear Wax Section, amended Shropshire Clinical Commissioning Group and Telford & Wrekin Clinical Commissioning Group to the CCGs Aligned Shropshire and Telford wording around cataracts and ear wax to one joint criteria for each. Amended wording on Bariatric Surgery Amendment within Hip Resurfacing Read: As per NICE guidance prosthesis should only be used if the evidence shows they require revision at a rate of less than 1 in 5% in 10 years NOW reads 1 in 5 (20%) Amendment Ear Wax duplicate line removed regarding irrigation Removed SCCG logo as no longer joint policy 2

3 1. INTRODUCTION 5 2. GENERAL SURGERY Varicose Veins Haemorrhoidectomy Hernia Management and Repair in Adults Bariatric Surgery 2.5 Circumcision 2.6 Surgery for Gallstones Venous Angioplasty for Multiple Sclerosis Hyperhidrosis Treatment Anal Skin Tag Removal ENT Insertion of Grommets Snoring Tonsillectomy Removal of Ear Wax MUSCULO-SKELETAL HEALTH Hip and Knee Replacement Surgery Hip Resurfacing Techniques (primary resurfacing arthroplasty of joint) Hip Impingement Syndrome Bunion Surgery Carpal Tunnel Syndrome Dupuytren's Disease Trigger Finger Ganglion Knee Arthroscopy Autologous Cartilage Transplantation Excision of Acromio-Clavicular Joint or Surgical Decompression of Sub-Acromial Space Joint Injections - Site of Procedure Spinal Fusion for Chronic Low Back Pain PAIN Epidural Injections (Lumbar and Caudal) and Facet Joint Injections for Back Pain Radiofrequency and Electrothermal Ablation for Chronic Back Pain Spinal Cord Stimulation for Chronic Pain UROLOGICAL- GENITARY PROBLEMS Treatment for Erectile Dysfunction Dilatation And Curettage for Menorrhagia Hysteroscopy for Menorrhagia Hysterectomy +/- Oophrectomy Mirena Coils Reversal of Female Sterilisation Reversal of Male Sterilisation IVF Routine Doppler Ultrasound Of Umbilical + Uterine Artery In Antenatal Care Elective Caesarean Section for Non-Clinical Reasons 30 3

4 7. EYE PROBLEMS Laser Surgery for Short Sight (Myopia) Cataract Surgery AESTHETIC SURGERY Abdominoplasty or Apronectomy Thigh Lift, Buttock Lift and Arm Lift, Excision of Redundant Skin or Fat Liposuction Breast Augmentation Breast Asymmetry Breast Lift (Mastopexy) Breast Reduction Revision Mammoplasty (including prosthesis removal or replacement) Inverted Nipple Correction Male Breast Reduction Surgery for Gynaecomastia Penile Implants, Labial Trimming and Cosmetic Genital Procedures Labiaplasty Vaginoplasty Hymenorrhaphy Pinnaplasty Blepharoplasty Face Lift or Brow Lift Hair Depilation (Hair removal) Hair Grafting - male pattern baldness Removal of Tattoos Removal of Benign Skin Lesions *solely for cosmetic reasons* Removal of Lipomata Repair of Lobe of External Ear (Split earlobes)* Resurfacing Procedures: Dermabrasion, Chemical Peels and Laser Treatment Rhinoplasty Scars and Keloids Botox Injection for the Ageing Face Congenital Vascular Lesions Other Cosmetic Procedures NEUROLOGY/NEUROSURGERY Inpatient Neuro-Rehabilitation MENTAL HEALTH Therapeutic Community Method Treatment for Borderline Personality Disorder MISCELLANEOUS Inpatient Cognitive Behavioural Therapy Complementary Medicines/Therapies Hyperbaric Oxygen Therapy 45 4

5 1 INTRODUCTION 1. This policy is an amalgamation of policies that have been agreed by Shropshire Clinical Commissioning Group (SCCG) and Telford and Wrekin Clinical Commissioning Group (TWCCG) herein after referred to as the CCGs. 2. Since the CCGs operate within finite budgetary constraints the policy makes explicit the need for the CCGs to prioritise resources and provide interventions with the greatest proven health gain. The intention is to ensure equity and fairness in respect of access to NHS funding. 3. To do this, the policy provides the list of interventions not routinely funded by the CCGs and the specified criteria required for the funding of certain other interventions. Please note that the policy guidance relating to these interventions should be read with reference to the principles detailed below, which includes the West Midlands Strategic Commissioning Group s definition of exceptionality. 4. Commissioners, general practitioners, service providers and clinical staff treating residents of Shropshire are expected to implement this policy. When interventions are undertaken on the basis of meeting criteria specified within the policy, this should be clearly documented within the clinical notes. Failure to do so will be considered by the CCGs as lack of compliance. 5. The CCGs explicitly recognise that for each of the interventions listed in this policy there may be exceptional clinical circumstances in which the CCG s would consider the funding of these interventions. It is not feasible to consider every possible scenario within this document. In cases where specified criteria are not met, applications may be considered on an individual basis through an Individual Funding Request (IFR) process. The IFR policy for Shropshire is available at and for Telford available at 6. In considering individual cases the CCGs apply the West Midlands Strategic Commissioning Group s definition of exceptionality: Where care is not routinely funded by the respective CCG, evidence must be included to show that the patient is significantly different to the population of patients with similar clinical needs who would also not be offered the treatment. This should include evidence that the patient is likely to gain significantly more benefit from the treatment than would be expected for other patients not currently offered it. 7. In considering such cases the CCGs seek to apply the West Midlands Strategic Commissioning Group s definition of exceptional clinical circumstances. These are defined as referring to a patient who has clinical circumstances which, taken as a whole, are outside the range of clinical circumstances presented by a patient within the normal population of patients with the same medical condition and at the same stage of progression as the patient. In making a case, therefore, the clinician must specify how this patient is clinically different from others currently excluded from treatment - either in reference to the clinical picture, the expected benefit, or both. 8. Unless a local commissioning policy is formally agreed with the CCGs the following circumstances will be considered to fall within the scope of this policy, and the relevant interventions will be deemed not normally funded by the either of the above CCGs: Newly developed, newly licensed or newly indicated interventions, including medical, surgical or drug-based treatments. Interventions found not to be cost-effective by the National Institute for Health and Clinical Excellence (NICE). 5

6 Interventions for which NICE Technology Appraisals Guidance (TAG) is pending or planned. Interventions approved by a NICE TAG but prior to the implementation deadline (usually 3 months from publication). Interventions deemed not normally funded within regional commissioning policies developed by the West Midlands Strategic Commissioning Group. 9. If patients choose to privately fund an intervention that is not normally funded by the CCGs, they will retain their entitlement to other elements of NHS care. For example, if they privately fund a cancer drug or cancer intervention not normally funded by the CCGs they will retain their entitlement to all the other elements of cancer care that other residents of Shropshire receive free of charge. However when patients are privately funding an intervention, they are responsible for all the costs associated with that intervention, including Consultant costs and diagnostics. They are therefore unable to receive a mixture of privately funded and the CCG s funded care within the same appointment or intervention - they cannot top-up a CCG s funded appointment or intervention by paying for an additional intervention to be provided or monitored during the same consultation. The relevant CCGs policies can be found on the CCG websites 10. This policy will be kept under regular review, to ensure that it reflects developments in the evidence base regarding clinical and cost effectiveness. 11. Unless providers are notified otherwise, implementation of the policy will continue to be monitored by selected audit of interventions against the criteria and by the application of policies within the Referral Assessment Service (RAS) for Shropshire patients and within Telford Referral and Quality Service (TRAQS) for Telford patients. 12. Implementation will be supplemented by continual monitoring of activity against the interventions. If substantial growth in activity occurs providers will be expected to investigate & confirm to the CCGs that they are complying with the policy. 2 GENERAL SURGERY 2.1 Varicose Veins Intro Varicose veins are dilated superficial veins in the leg. They are caused by incompetent valves, commonly in the long and short saphenous veins and their branches, although varicosities may be secondary to deep venous disease. They are not to be confused with intra-dermal spider veins or thread veins which lie within the skin. Asymptomatic or mild varicose veins present as a few isolated, raised palpable veins with no associated pain, discomfort or any skin changes. Moderate varicose veins present as local or generalised dilatation of subcutaneous veins with associated mild pain or discomfort and slight ankle swelling. Severe varicose veins may present with phlebitis, ulceration, haemorrhage, significant oedema or haemosiderin staining. Most varicose veins respond to conservative management, i.e. class one or two compression stockings (Note: NICE CG 168 recommends - Do not offer compression hosiery to treat varicose veins unless interventional treatment is unsuitable), exercise, weight loss and elevation of the leg 2-3 times daily. Varicose eczema, if severe or inflamed, can be treated effectively with topical steroids. Interventional procedures such as surgical stripping or ligation, radio-frequency ablation, endoscopic procedures and sclerotherapy (e.g. foaming ) can improve 6

7 symptoms in the short term but are less effective in the longer term, and are associated with a significant recurrence rate. Interventional procedures for mild and moderate varicose veins will not normally be funded the CCGs Unless one or more of the criteria below are met, interventional procedures for varicose veins are not routinely funded: Varicose veins which have bled and are at risk of bleeding again OR A history of varicose ulceration OR Signs of prolonged venous hypertension (haemasiderin pigmentation, eczema, induration [lipodermatosclerosis], or significant oedema associated with skin changes) OR Superficial thrombophlebitis in association with varicose veins OR Significant symptoms attributable to chronic venous insufficiency which are having a significant impact on quality of life. OPCS : L Subsidiary codes X30.5, X30.8 or X30.9 with codes Z39.5 or Z39.8. The ICD 10 Code for varicose veins of lower extremities is I80. There is no Code to identify those which have bled or are at risk of bleeding again. for the other clinical criteria are any one of I83.0 or I83.2; I87.2; I80.0 or I80.1 or I80.2 or I80.3 or There is no appropriate code to identify impact on quality of life. 7

8 2.2 Haemorrhoidectomy Intro Haemorrhoids, also known as piles, are enlarged and swollen blood vessels in or around the lower rectum and anus. They can occur at any age and affect both sexes. Conservative management consists of high fibre diet, exercise, weight loss and topical preparations, followed by non-surgical ablative/fixative interventions and rubber band ligation. Surgical haemorrhoidectomy can be used for third or fourth degree haemorrhoids. Unless all the following criteria are met haemorrhoidectomy are not routinely funded: Recurrent third or fourth degree internal haemorrhoids AND Persistent pain or bleeding AND Failed conservative treatment OR Symptomatic external haemorrhoids. OPCS : H The ICD 10 Code for haemorrhoids is I84. The to identify persistent pain or bleeding are any one of: I84.1, I84.4, I84.8. However there are no appropriate ICD 10 codes for recurrent third or fourth degree haemorrhoids or failure of conservative treatment. 2.3 Hernia Management and Repair in Adults Intro A hernia is where an internal part of the body pushes through a weakness in the muscle or surrounding tissue wall, usually appearing as a lump on the body. Abdominal Wall Hernia Repair is regarded as a procedure of low clinical priority and therefore not routinely funded by the commissioner. NB: All suspected femoral hernias do not require prior approval to be sought - Please refer patients direct to secondary care. A hernia is defined as a protrusion of a sac of peritoneum, often containing intestine or other abdominal contents, from its proper cavity through a weakness in the abdominal wall. They usually present as a lump, and patients often experience pain or discomfort that can limit daily activities. In addition, hernias can present as a surgical emergency should the bowel strangulate or become obstructed due to the hernia. There are many different types of hernia; those that are covered in this policy include inguinal, femoral, umbilical ventral and incisional hernias. This policy covers the management of inguinal, femoral, umbilical, ventral and incisional hernias, with criteria for referrals/treatment. Initial management of patients with hernia Patients with BMI >35: the decision to refer requires particular care, as the benefits of intervention may well be outweighed by risks of surgical intervention, including poorer healing and higher complication rates. If in doubt, the clinician may refer the patient, but should advise them that surgery may not be an appropriate option for them. Referral to local weight management programmes should be offered. Patients who smoke should be warned of clinical advice that hernia recurrence rates are 3 times higher in smokers than non-smokers. All patients who smoke should be encouraged to stop and offered information on local cessation support services. 8

9 Inguinal: For asymptomatic or minimally symptomatic hernias, the commissioner advocates a watchful waiting approach including providing reassurance, pain management etc. under informed consent. Surgical treatment will only be approved when one of the following criteria is met: symptomatic i.e. symptoms are such that they cause significant functional impairment OR the hernia is difficult or impossible to reduce, [ie. history of incarceration or real difficulty reducing the hernia confirmed by ultrasound] OR Inguino-scrotal hernia, OR The hernia increases in size month on month. Umbilical: Surgical treatment will only be approved when one of the following criteria is met: pain/discomfort that causes significant functional impairment OR increase in size month on month OR to avoid incarceration or strangulation of bowel Incisional: Surgical treatment will only be approved when both of the following criteria are met: Pain/discomfort that causes significant functional impairment AND 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 Hernia surgery is not commissioned in patients with groin pain, but no visible external swelling. Patients presenting with groin pain who are found to have an impalpable hernia on ultrasound should not be referred for hernia repair. Management of persistent groin pain that has not resolved after a period of watchful waiting should be based on individual clinical assessment. Where groin pain is severe and persistent with diagnostic uncertainty, options include referral for musculoskeletal assessment or imaging. Ultrasound should not be routinely requested in the early management of groin pain. Laparoscopic hernia repair Laparoscopic hernia repair is not commissioned for primary unilateral hernia repair. Laparoscopic hernia repair is commissioned only for bilateral hernia repair (where the patient has bilateral hernias with external swelling on clinical examination) or for recurrent hernia. Hernia surgery is not commissioned for impalpable hernias found incidentally during laparoscopic repair of a hernia on the other side. OPCS : T , 21.8, Also subsidiary codes Y in association with ICD 10 code K40. The ICD 10 code for inguinal hernia is K40. for symptomatic inguinal 9

10 hernias are any K40.0, 40.1, 40.3 or Bariatric Surgery Intro Bariatric Surgery Tier 4 bariatric surgery is commissioned by NHSE in line with NICE guidance. Tier 3, policy under review. 2.5 Circumcision Intro Circumcision is a surgical procedure that involves partial or complete removal of the foreskin of the penis. It is an effective procedure and confers benefit for a range of medical indications. Sometimes it is requested on cultural, social and religious reasons. These non-medical circumcisions do not confer any health gain but do carry measurable health risk. Unless one or more of the following criteria are met circumcision is not routinely funded: Phimosis in children with spraying, ballooning and/or recurrent infection OR Adult Phimosis or paraphimosis OR Recurrent (>3 documented episodes) of balantitis or balanoposthitis OR Balanitis xertotica obliterans OR Suspected malignancy OR Dermatological disorders unresponsive to treatment OR Congenital urological abnormalities when skin is required for grafting OR Interference with normal sexual activity in adult males. OPCS Code: N30.3. ICD 10 for the specified clinical criteria are any one of: N47; N48.1 (>3 documented episodes); N48.6; C60 (suspected or proven); N48.3. However there are no appropriate ICD 10 codes unresponsive dermatological disorders or congenital abnormalities requiring skin for grafting. 2.6 Surgery of Gallstones Intro Gallstones are small stones, usually made of cholesterol, that form in the gallbladder. In most cases they do not cause any symptoms. Gallstone disease is relatively straightforward to treat. The most widely used treatment is keyhole surgery to remove the gallbladder. Doctors refer to this as a laparoscopic cholecystectomy. Cholecystectomy is the surgical removal of the gall bladder. Prophylactic cholecystectomy is not indicated in most patients with asymptomatic gallstones. The removal of the gallbladder for asymptomatic gall stones is regarded as a procedure of low clinical value and therefore not routinely funded by the Commissioner. Note: Patients with suspected gallbladder carcinoma or severe complications should be referred immediately, without delay. to Access Treatment 10

11 Patients with diabetes mellitus/transplant recipient patients/patients with cirrhosis who have been managed conservatively and subsequently develop symptoms Where there is clear evidence of patients being at risk of gallbladder carcinoma Where there is clear evidence of patients being at risk of gallbladder complications Confirmed episode of gall stone induced pancreatitis Confirmed episode of cholecystitis Episode of obstructive jaundice caused by biliary calculi OPCS : J Subsidiary codes Y in association with ICD 10 code K80.2 or K80.5 The ICD 10 Code for gallstones is K80. However there are no appropriate to identify asymptomatic gallstones from those with a history of symptomatic gallstones, nor are there to identify those at risk of malignancy or complications. 2.7 Venous Angioplasty for Multiple Sclerosis Intro The effectiveness of venous angioplasty for stenotic and occlusive lesions in the extracranial venous systems of patients with MS has not yet been demonstrated in clinical trials. The American Academy of Neurology currently recommends that patients only use this treatment as part of a well designed clinical trial. Venous angioplasty for the treatment of Multiple Sclerosis is not routinely funded. OPCS : L94.6, 94.7, 94.8, ICD 10 Code for Multiple Sclerosis is G Hyperhidrosis Treatment Intro Hyperhidrosis can be generalised or focal. Generalised hyperhidrosis involves the entire body, and is usually part of an underlying condition, most often an infectious, endocrine or neurological disorder. Focal hyperhidrosis is an idiopathic disorder of excessive sweating that mainly affects the axillae, the palms, the soles of the feet, and the face of otherwise healthy people. There are a number of treatments available for focal hyperhidrosis: Aluminium chloride-based topical treatments e.g. Aluminium salts are the most common ingredient in over-the-counter antiperspirants. This can be initiated in primary care. Lontophoresis which is primarily used for the hands and feet (the easiest parts of the body to submerge), this procedure entails placing the hands or feet in a shallow basin of water, through which electric current is passed, this is normally arranged via the dermatologists. Botulinum Toxin: inhibit the release of acetylcholine at the presynaptic nerve endings of the motor endplates, sweating be reduced/eradicated but may require further injections at a later date, i.e. it is not a permanent cure and needs repeating between 6 months and 2 years depending of severity of recurrent symptoms, initiated by referral to the vascular surgeons. 11

12 Invasive surgical treatments, such as endoscopic thoracic sympathectomy, offering permanent resolution, but with the risks associated with an interventional procedure, initiated by referral to vascular surgeon. 1) Botulinum Toxin. Funded as part of an appropriate clinical pathway for the treatment of focal Hyperhydrosis. (for example, The CCGs recommend Botulinum toxin for hyperhidrosis of the axillae which does not respond to topical treatments with antiperspirants or antihidrotics). 2) Endoscopic Thoracic Sympathectomy. Endoscopic Thoracic Sympathectomy for the treatment of hyperhidrosis is funded provided that the patient has been through a pathway of care involving assessment and then an appropriate trial of conservative treatment, including when appropriate topical treatment with Aluminium Chloride antiperspirants normally and if appropriate iontophoresis over a period of at least 6 months (including time treated within primary care or under the dermatologists). OPCS : A75.2, 76.2, 77.2, 78.2, The ICD 10 Code for hyperhidrosis is R Anal Skin Tag Removal Intro Skin tags are small flesh-coloured or brown growths that hang off the skin and look a bit like warts. They are very common and harmless. Skin lesions are often referred for specialist opinion because of concerns that there may be a malignancy. This should be done through the appropriate referral route if malignancy is suspected. Once it is established that a skin lesion is not malignant its removal will not normally be funded, though a surgeon may request funding in exceptional cases. Removal of Anal Skin Tags is regarded as a procedure of low clinical value and therefore not routinely funded. 12

13 3 ENT 3.1 Insertion of Grommets Intro Glue ear is a common childhood condition in which the middle ear becomes filled with fluid. The medical term for glue ear is otitis media with effusion. Grommets can help drain fluid out of the middle ear. Grommet insertion is regarded as a procedure of low clinical priority and therefore not routinely funded by the Commissioner. A. Children The CCGs will fund treatment with grommets for children with otitis media with effusion (OME) where: OME persists after a period of at least three months watchful waiting from the date that the problem was first identified by the GP to the date of referral AND the child is 3 years or older AND there is hearing significant hearing loss (of at least 25dB) - particularly in the lower tones (low frequency loss) - and evidence of a disability as a result of this hearing loss on at least 2 documented occasions (following repeat testing after 6-12 weeks) with either: Delay in speech development OR educational or behavioural problems attributable to the hearing loss OR a significant second disability that may itself lead to developmental problems e.g. Down s syndrome, Turner s syndrome or cleft palate. The CCGs will fund treatment for grommets in children with acute otitis media when there have been at least 5 recurrences of acute otitis media, which required medical assessment and/or treatment, in the previous year. B. Adults NHS England will fund grommets in adults with OME only in the following circumstances: Significant negative middle ear pressure measured on two sequential appointments AND significant ongoing associated pain. OR Unilateral middle ear effusion where a post nasal space biopsy is required to exclude an underlying malignancy. OPCS Code : D15.1 ICD 10 codes for those meeting the clinical criteria are any of: H65.0 (5 or > documented episodes), 65.1 (5 or > documented episodes), 65.3 or There are no appropriate codes for hearing level, hearing loss or effects on the child. 13

14 3.2 Snoring Intro This policy explicitly refers to isolated snoring. It is recognised that some patients may have snoring in conjunction with obstructive sleep apnoea (OSA) - if such patients are considered eligible for surgery this will be funded only when it is required for treatment of their OSA. Surgery for snoring is not routinely funded. OPCS F32.4, 32.5, There are no ICD 10 for snoring, but for those meeting clinical criteria the codes are G47.3 or G Tonsillectomy Intro These criteria are in line with SIGN 2010 guidance and initiatives across the West Midlands. It should be noted that there is no high quality evidence in adults for the effectiveness of tonsillectomy as a treatment for recurrent sore throats, and benefits may be outweighed by the morbidity associated with surgery in children who are not severely affected. Unless the following criteria are met tonsillectomy for recurrent sore throats is not routinely funded: In both children and adults with recurrent acute sore throats: 7 or more well documented, clinically significant, adequately treated sore throats in the preceding year or 5 or more such episodes in each of the preceding two years or 3 or more such episodes in each of the preceding three years AND Sore throats are due to acute tonsillitis AND The episodes of sore throat are disabling and prevent normal functioning (e.g. such as school attendance or work) Other funded indications include: Peri-tonsillar abcess with a history of recurrent tonsillitis OR Tonsillar enlargement in children sufficient to cause airway obstructionconfirmed by overnight pulseoximetry interpreted by a respiratory paediatrician OR Suspected or proven malignancy. When in doubt as to whether a tonsillectomy would be beneficial, a six month period of watchful waiting is recommended. OPCS : F Subsidiary Y and Y with code Z25.7. The ICD-10 Code for acute sore throat is J02 and for acute tonsillitis is J03, but the number of episodes cannot be captured by ICD 10, and there are no appropriate codes for impact on normal functioning. for the other funded indications are any one of: J36; G47.3 or G47.9; C09 (suspected or proven). 14

15 3.4 Removal of Ear Wax Intro This policy relates to the removal of ear wax. Ear wax removal is not routinely funded by either CCG. Patients should only be referred if the following criteria are met: The person has (or is suspected to have) a chronic perforation of the tympanic membrane. There is a past history of ear surgery. There is a foreign body, including vegetable matter, in the ear canal. Ear drops have been unsuccessful and irrigation is contraindicated. The patient is suffering from significant symptoms due to ear wax build up including hearing loss or pain and the patient s condition warrants microsuction Has a recent history of Otalgia and /or middle ear infection (in past 6 weeks) Has had previous complications following ear irrigation including perforation of the ear drum, severe pain, deafness, or vertigo Two attempts at Irrigation of the ear canal in primary care are unsuccessful Earwax should only be removed if: If earwax is totally occluding the ear canal and any of the following are present: Hearing loss Earache Tinnitus Vertigo Cough suspected to be due to earwax If the tympanic membrane is obscured by wax but needs to be viewed to establish a diagnosis. If the person wears a hearing aid, wax is present and an impression needs to be taken of the ear canal for a mould, or if wax is causing the hearing aid to whistle OPCS : F Subsidiary Y and Y with code Z25.7. The ICD-10 Code for acute sore throat is J02 and for acute tonsillitis is J03, but the number of episodes cannot be captured by ICD 10, and there are no appropriate codes for impact on normal functioning. for the other funded indications are any one of: J36; G47.3 or G47.9; C09 (suspected or proven). 15

16 4 MUSCULO-SKELETAL HEALTH 4.1 Hip and Knee Replacement Surgery Intro Orthopaedic Care Pathway and Oxford Scoring Tool Unless all of the following criteria are met primary Hip and Knee replacement surgery is not routinely funded: The patient has a BMI below 40 OR if the BMI is 40 or above there is documented participation in a weight management programme for at least 6 months prior to surgery AND Conservative means (e.g. Analgesics, NSAIDs, physiotherapy) have failed to alleviate the patient s pain and disability) AND Pain and disability should be sufficiently significant to interfere with the patient s daily life and/or ability to sleep. Surgical intervention will only routinely be offered to those patients with an Oxford hip and knee score of 26 or lower. As per NICE guidance prosthesis should only be used if the evidence shows they require revision at a rate of less than 1 in 10 (10%) in 10 years. Where prosthesis has not been in use for more than 10 years, then best research evidence should be provided. OPCS : Hips: W37.1, 37.2, 37.8, 37.9, 38.1, 38.2, 38.8, 38.9, 39.1, 39.2, 39.8, 39.9, 93.1, 93.2, 93.8, 93.9, 94.1, 94.2, 94.8, 94.9, 95.1, 95.2, 95.8, Knees: W40.1, 40.2, 40.8, 40.9, 41.1, 41.2, 41.8, 41.9, 42.1, 42.2, 42.8, 42.9 and O18.1, 18.2, 18.8, There are no appropriate ICD 10 for the clinical criteria. 4.2 Hip Resurfacing Techniques (primary resurfacing arthroplasty of joint) Intro NICE guidance executive have proposed to include a further appraisal of the clinical and cost effectiveness of total hip replacement and surface replacement within its licensed indication for the treatment pain resulting from end stage arthritis of the hip within its work programme for 2012/13. This guidance will be amended upon receipt of this appraisal. Metal on metal (MoM) hip resurfacing arthroplasty involves removal of the diseased or damaged surfaces of the head of the femur and the acetabulum. The femoral head is fitted with a metal surface and the acetabulum is lined with a metal cup to form a pair of metal bearings. There is sufficient short-term evidence to conclude that hip re-surfacing is clinically and cost-effective but the studies have been undertaken in people aged under 65 years. NICE guidance recommends their use in those likely to outlive a conventional THR (i.e. young and active), but advises surgeons to discuss the lack of long-term evidence on safety and reliability with patients. Except in the following patients MoM hip resurfacing techniques is not routinely funded: Who otherwise qualify for a primary total hip replacement AND Who are likely to outlive conventional primary hip replacements N.B. As per NICE guidance prosthesis should only be used if the evidence shows they require revision at a rate of less than 1 in 5 (20%) in 10 years. Where prosthesis 16

17 has not been in use for more than 10 years, then best research evidence should be provided. sent to Stephen White at RJAH to confirm wording 30/12/14 OPCS : W58.1 with Z84.3 (Hip Joint). There are no appropriate ICD 10 for the clinical criteria. 4.3 Hip Impingement Syndrome Intro Hip impingement syndrome is caused by unwanted contact between abnormally shaped parts of the head of the thigh bone and the hip socket. This results in limited hip movement and pain. Open or arthroscopic femero-acetabular surgery for hip impingement is commissioned if the following criteria are met: 1. Labral tear or impingement has been confirmed on MRI; AND 2. 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. 3. 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. 4. 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 for relief of the symptoms in the short and medium term AND 5. The surgeon must have completed specialist training and have experience of providing arthroscopic hip surgery; AND 6. 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); AND 7. The provider will undertake local review of cases to monitor safety and short term outcomes. The clinician proposing this intervention will make the decision to treat based on the criteria set out above. An annual audit will be completed to confirm that patients have been treated in accordance with these criteria. 17

18 4.4 Bunion Surgery Intro A bunion is a bony swelling at the base of the big toe. Not all people with bunions are symptomatic (have symptoms). The removal of asymptomatic bunions (no symptoms present) is regarded as a procedure of low clinical priority and therefore not routinely funded by the Commissioner. Referral to Orthopaedic or podiatric surgery should only be made in the following circumstances: The patient has been reviewed by local podiatry service In addition, the patient meets at least one of the following criteria: Self-care advice and analgesia has been tried and symptoms are not improving OR Severe pain unrelieved by conservative measures OR Recurrent infection OR Recurrent ulcers Requests for the removal of symptomatic bunions will ONLY be considered where patients must have first been managed via MSK or podiatry services before consideration for Orthopaedic surgery and where: AND OR Conservative methods have failed Severe deformity (overriding toes) is causing significant (documented) functional impairment Severe pain is causing significant functional impairment Do not offer referral or surgery for concerns about the appearance of feet and ensure patients are aware of the pros and cons of surgery 4.5 Carpal Tunnel Syndrome Intro Carpal tunnel syndrome is a relatively common condition that affects the nerves of the hand - causing pain, numbness and a burning or tingling sensation in the hand and fingers. Symptoms can be intermittent, and range from mild to severe. Patients with intermittent or mild/moderate symptoms should be managed conservatively in the first instance. Carpal tunnel surgery is regarded as a procedure of low clinical priority for patients with intermittent or mild to moderate symptoms and therefore not routinely funded by the Commissioner. The Commissioner will fund carpal tunnel surgery where: Symptoms persist despite at least 3 months of conservative therapy with either local corticosteroid injection and/or nocturnal splinting. 18

19 OR There is neurological deficit, e.g. Sensory blunting, muscle wasting or weakness of thenar abduction. OPCS : A65.1, The ICD 10 code for Carpal Tunnel syndrome is G56.0, but there are no appropriate for the clinical criteria. 4.6 Dupuytren s Disease Intro Dupuytren s Disease can be managed conservatively with physiotherapy, wrist splints, NSAIDs, and steroid injections. There are recognised criteria where surgical release may be beneficial. Requests for treatment will be considered when: The patient has a 30 degree fixed flexion deformity at either the metacarpophalanageal joint or proximal interphalangeal joint AND The patient cannot flatten their fingers or palm on a table OR There has been rapid progression over a few months OPCS : A65.1, The ICD 10 code for Carpal Tunnel syndrome is G56.0, but there are no appropriate for the clinical criteria. 4.7 Trigger Finger Intro Trigger Finger. Unless one or more of the following criteria are met surgical treatment is not routinely funded: Failure to respond to conservative measures (for example, steroid or hydrocortisone injections) OR Fixed deformity that cannot be corrected. OPCS : T69.1, 69.2, 69.8, 69.9, 70.1, 70.2, 71.8, 71.9, 72.3, 72.8, 72.9 with any one of Z89.4, 89.5, 89.6, The ICD 10 Code for Trigger Finger is M65.3, but there are no appropriate ICD 10 for the clinical criteria. 4.8 Ganglion Intro Ganglia are benign fluid filled, firm and rubbery in texture lumps. They occur most commonly around the wrist, but also around fingers, ankles and the top of the foot. They are usually painless and completely harmless. Many resolve spontaneously especially in children (up to 80%). Reassurance should be the first therapeutic intervention. Aspiration alone can be successful but recurrence rates are up to 70%. Surgical excision is the most invasive therapy but recurrence rates of up to 40% have been reported. Complications of surgical excision include scar sensitivity, joint stiffness and distal numbness. Unless one or more of the following criteria are met surgical removal of ganglia is not routinely funded: Ultrasound is the minimum investigation to ensure correct diagnosis of ganglion before the following criteria are applied: 19

20 Ganglia at the wrist - symptomatic (painful) or neurovascular compromise OR Seed ganglia arising at the base of the digits - symptomatic (painful) OR Mucoid cysts arising at the DIP joint - disturbing nail growth or have a tendency to discharge OPCS : T The ICD 10 code for Ganglion is M67.4, but there are no appropriate ICD 10 for the clinical criteria. 4.9 Knee Arthroscopy Intro As less invasive investigations have become more readily accessible the role of diagnostic arthroscopy is diminishing. The following policy statement is in line with initiatives across the West Midlands. 1) Washout and debridement in Osteoarthritis Unless there are documented mechanical features of locking which is associated with severe pain, arthroscopic debridement and washout is not routinely funded for chronic pain relief of osteoarthritis of the knee. 2) Diagnostic Arthroscopy Unless one or more of the following criteria are met diagnostic arthroscopy of the knee is not routinely funded: Knee pain with diagnostic uncertainty following an MRI scan OR Suspected malignancy, infection, nerve root impingement, bony fracture or avascular necrosis. 3) Therapeutic Arthroscopy Unless all of the following criteria are met therapeutic arthroscopy of the knee is not routinely funded: Clinical examination by a consultant specialist or an MRI scan has demonstrated clear evidence of an internal joint derangement (meniscal tear, ligament rupture or loose body) AND Where conservative treatment has failed or where it is clear that conservative treatment will not be effective (N.B. Subsidiary code Y767 with Z846 apply to knee arthroscopy, but it is not clear which category described below they fall into) 1) Washout and debridement in Osteoarthritis OPCS : W82.2, 82.3, 83.3, 83.6, 85.2, 85.8, The ICD 10 Code for Osteoarthritis is M15.0, but there are no appropriate for the clinical criteria. 2) Diagnostic Arthroscopy OPCS : W87.1, 87.8, ICD 10 for the clinical criteria are any one of (suspected): M36.1; M00 or M01; S72.4 or S72.8 or S72.9 or S82.1 or S82.9; M87. There is no appropriate Code for diagnostic uncertainty, but MRI is U13.3 or U21.1, with Z

21 3) Therapeutic Arthroscopy OPCS : W , , (W with Z84.6). The ICD 10 Code for internal derangement of the knee is M23. There are no appropriate for conservative management Autologous Cartilage Transplantation Intro NICE guidance states that autologous chondrocyte implantation (ACI) is not recommended for the treatment of articular cartilage defects of the knee joint, except in the context of on-going or new clinical studies that are designed to generate robust and relevant outcome data, including the measurement of healthrelated quality of life and long-term follow-up. Patients should be fully informed of the uncertainties about the long term effectiveness and the potential adverse effects of this procedure This procedure is not routinely funded except as part of an ongoing research programme. OPCS : W85.3, (W71.4 or 89.2 with Z84.6) Excision of Acromio-Clavicular Joint or Surgical Decompression of Sub- Acromial Space Intro Excision of Acromio-Clavicular Joint or Surgical Decompression of Sub-Acromial Space Unless one or more of the following criteria are met this is not routinely funded: Failure of conservative treatment OR If a temporary improvement has been demonstrated using injection surgery. OPCS : O29.1, (W08.5 or 08.9 or 57.2 with Z81.2). There are no appropriate ICD 10 for the clinical criteria Joint Injections Site of Procedure Intro This policy statement relates only to adults (i.e. aged 19 and over), as it is recognised that children often require joint injections under general anaesthesia. Policy statement: Joint injections in adults should not be done in a sterile theatre unless general anaesthetic is required. If imagery guidance is required then they should be done in a suitable area with the approved technology. They will normally be funded as an outpatient procedure. OPCS : W90.3, Spinal Fusion for Chronic Low Back Pain Intro There is a body of evidence demonstrating that spinal fusion is no more clinically effective or cost-effective than a multi-disciplinary rehabilitation programme (physiotherapy, exercise and psychological input) for chronic (>1 year) degenerative back pain. Unless the following criteria are met spinal fusion will not be routinely funded for chronic degenerative low back pain: The patient has been assessed by a clinician trained in the diagnosis and management of chronic low back pain AND The low back pain has lasted more than one year and is documented as significantly interfering with daily life (e.g. loss of function > 50% on EuroQol 21

22 or BPI tool) AND Conservative treatments, undertaken after assessment by a pain management specialist, have failed (physiotherapy guided exercise, maximal analgesia and muscle relaxants, psychological therapy). N.B There are a number of other exclusions to this statement, recognising indications other than chronic degenerative low back pain for Spinal Fusion. These are: Clear cut root compression OR Spinal Stensosis OPCS : V , , (V38.8, 38.9, 39.8, 39.9, 40.1, 40.4, 40.8 or 40.9 with Z06.3 or Z67.6). The ICD 10 for low back pain are M54.5, M51.2 or (M47.8, 48.5, 48.9, 51.3, 51.8, 51.9, 54.8 or 54.9 with site code 5,6,7 or 8). There are no appropriate for the clinical criteria - for those provided as an N.b. the ICD 10 are: M51.0, , , or (G55.1, 55.2, 55.3 or 99.2 with site codes 5,6,7 0r 8); M48.0; M

23 5 PAIN 5.1 Epidural Injections (Lumbar and Caudal) and Facet Joint Injections for Back Pain Intro Epidurals/extradurals are the instillation of local anaesthetic and/or corticosteroids into the potential space between the membranes (dura) which surround the spinal cord. Facet joint injections are the instillation of local anaesthetic and/or corticosteroids into the facet joint (intra-articular injections), or into surrounding nerves (medial branch blocks). Much of the evidence relating to these interventions is of poor quality, and it is difficult to pool results due to the heterogeneity of study populations. However the RCTs, systematic reviews and NICE review that have been published have generally concluded that injection therapies are of no benefit in sub-acute or chronic back pain (lasting > 6 weeks but < 1 year). There may, however, be specific sub-groups who may respond to a specific type of injection therapy. 1) Unless all the following criteria are met epidurals (lumbar and caudal) for low back is not routinely funded: a) Non-specific low back pain Pain lasting more than 6 weeks but less than one year Maximal oral and topical analgesia has failed AND A clinician trained in back pain assessment, diagnosis and management has assessed the patient and considers it would enable mobilisation and participation in rehabilitation AND It is part of a dedicated physiotherapy based mobilisation programme, i.e. the interventions is intended to enable mobilisation and participation in rehabilitation (they will not be funded as standalone treatments) Limitation: No more than 2 therapeutic epidurals will be funded in these circumstances. b) Acute radicular low back pain Pain lasting more than 3 weeks but less than one year Radicular pain is consistent with the level of spinal involvement (below the knee for lower lumbar herniations and into the anterior thigh for upper lumbar herniations) AND Symptoms have persisted for at least 3 weeks despite maximal oral and topical analgesia AND A clinician trained in back pain assessment, diagnosis and management has assessed the patient and considers it would enable mobilisation and participation in rehabilitation AND It is part of a dedicated physiotherapy based mobilisation programme, i.e. the interventions is intended to enable mobilisation and participation in rehabilitation (they will not be funded as stand alone treatments) Limitation: No more than 2 epidurals will be funded in these circumstances. 2) Unless all the following criteria are met facet joint injections of any type are not routinely funded for low back pain: Low back pain lasting more than 6 weeks but less than one year A clinician trained in back pain assessment, diagnosis and management has assessed the patient and considers the facet joint as the cause of pain AND Maximal oral and topical analgesia has failed AND 23