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Greater Manchester EUR Policy Statement on: Varicose Veins GM Ref: GM003 Version: 2.0 (March 2017) Commissioning Statement Varicose Veins Policy Inclusion Criteria All patients should be given advice on lifestyle changes, exercise and skin care. Secondary care referral and management is commissioned for the following: Urgent referral for bleeding • They are bleeding from a varicosity. • They have bled from a varicosity and are at risk of bleeding again. Funding Mechanism Monitored approval: Referrals may be made in line with the criteria without seeking funding. NOTE: May be the subject of contract challenges and/or audit of cases against commissioned criteria. Severe varicose veins Referral to a vascular service for patients with severe varicose veins – these are varicose veins that are associated with any one of the following: • They have an ulcer which is progressive and/or painful. • They have recurrence of an ulcer • They have an ulcer which has failed to respond to 12 weeks or more of active treatment or is deteriorating despite treatment • Progressive skin changes indicative of venous disease that may benefit from surgery. Funding Mechanism Monitored approval: Referrals may be made in line with the criteria without seeking funding. NOTE: May be the subject of contract challenges and/or audit of cases against commissioned criteria. Except for Wigan Borough CCG which will be: Individual prior approval provided the patient meets the above criteria. Requests should be submitted with all relevant supporting evidence, which must be provided with the request. Moderate varicose veins Patients with: • Atrophy blanche with hemosiderin deposition. • Extensive tortuous varicose veins of the whole lower limb (indicative of long saphenous insufficiency) who would be considered at high risk of bleeding from minor external trauma. Funding Mechanism Individual prior approval provided the patient meets the above criteria. Requests should be submitted with all relevant supporting evidence, which must be provided with the request. GM Varicose Veins Policy v2.0 FINAL Page 2 of 17 Secondary care management On referral, duplex ultrasound to confirm the diagnosis and determine the presence and extent of truncal reflux should be undertaken prior to invasive treatment being undertaken. Treatment should be offered as follows: 1. First offer endothermal ablation (NICE IPG8 and 52). 2. If endothermal ablation is unsuitable offer ultrasound guided foam sclerotherapy (NICE IPG440). 3. If ultrasound guided foam sclerotherapy is unsuitable then offer surgery. NOTE: • If incompetent varicose tributaries are to be treated, consider treating them at the same time. • If compression hosiery or bandaging is offered do not use for more than 7 days. • Do not use compression hosiery to treat varicose veins unless interventional treatment is not suitable. • Do not carry out interventional treatment of varicose veins during pregnancy except in exceptional circumstances. Clinical Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if Exceptionality they feel there is a good case for exceptionality. Exceptionality means ‘a person to which the general rule is not applicable’. Greater Manchester sets out the following guidance in terms of determining exceptionality; however the over-riding question which the IFR process must answer is whether each patient applying for exceptional funding has demonstrated that his/her circumstances are exceptional. A patient may be able to demonstrate exceptionality by showing that s/he is: • Significantly different to the general population of patients with the condition in question. and as a result of that difference • Policy Exclusions They are likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition. Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathways for this exclusion to take effect). NOTE: Thread veins and spider naevus / telangiectasia are included within the GM Common Benign Skin Lesions policy. GM Varicose Veins Policy v2.0 FINAL Page 3 of 17 Contents Commissioning Statement ........................................................................................................................ 2 Policy Statement ...................................................................................................................................... 5 Equality & Equity Statement ..................................................................................................................... 5 Governance Arrangements....................................................................................................................... 5 Aims and Objectives ................................................................................................................................. 5 Rationale behind the policy statement ...................................................................................................... 6 Treatment / Procedure.............................................................................................................................. 6 Epidemiology and Need ........................................................................................................................... 6 Adherence to NICE Guidance .................................................................................................................. 6 Audit Requirements .................................................................................................................................. 7 Date of Review .........................................................................................................................................7 Glossary ...................................................................................................................................................7 References ...............................................................................................................................................7 Governance Approvals ............................................................................................................................. 7 Appendix 1 – Evidence Review ................................................................................................................ 9 Appendix 3 – Diagnostic and Procedure Codes...................................................................................... 14 Appendix 4 – Version History ................................................................................................................. 16 GM Varicose Veins Policy v2.0 FINAL Page 4 of 17 Policy Statement Greater Manchester Shared Services (GMSS) Effective Use of Resources (EUR) Policy Team in conjunction with GM EUR Steering Group have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document. In creating this policy GMSS has reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester. This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR). Equality & Equity Statement GMSS/CCGs have a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012. GMSS/CCG is committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, GMSS/CCG will have due regard to the different needs of protected characteristic groups, in line with the Equality Act 2010. This document is compliant with the NHS Constitution and the Human Rights Act 1998. This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GMSS Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their ‘starting point’ is considered to be further back than any other group. This will be reflected in GMSS evidencing taking ‘due regard’ for fair access to healthcare information, services and premises. An Equality Analysis has been carried out on the policy. Analysis, please contact [email protected]. For more information about the Equality Governance Arrangements Greater Manchester EUR policy statements will be ratified by the Greater Manchester Association Governing Group (AGG) prior to formal ratification through CCG Governing Bodies. Further details of the governance arrangements can be found in the Greater Manchester EUR Operational Policy. Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by: • reducing the variation in access to treatments/procedures. GM Varicose Veins Policy v2.0 FINAL Page 5 of 17 • ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. • reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester. • promoting the cost-effective use of healthcare resources. Rationale behind the policy statement To consolidate current commissioning arrangements across Greater Manchester and to begin the shift towards commissioning these services in line with NICE CG168, which radically altered the treatment pathway for varicose veins. This policy has been developed to reflect the updated pathway. Treatment / Procedure In some people varicose veins are asymptomatic or cause only mild symptoms, but in others they cause pain, aching or itching and can have a significant effect on their quality of life. Varicose veins can cause skin changes, varicose eczema and varicose ulceration. Bleeding or thrombophlebitis may also occur. Previous PCT commissioning policies for varicose veins required that all patients had undergone conservative management including the use of compression stockings and that only those with severe varicose veins should be referred for surgery. This guidance recognises a desire to move towards commissioning a service for the treatment of varicose veins based on NICE CG168 but recognises that before this can happen there is a need to ensure that all stages of the pathway identified in NICE IPG168 are available locally and that patients are managed in line with that guidance. Until the pathway and supporting commissioning work is completed then patients should be referred using the criteria listed in this policy. Epidemiology and Need Varicose veins are dilated, often palpable subcutaneous veins with reversed blood flow. They are most commonly found in the legs. Estimates of the prevalence of varicose veins vary. Visible varicose veins in the lower limbs are estimated to affect at least a third of the population. Risk factors for developing varicose veins are unclear, although prevalence rises with age and they often develop during pregnancy. In some people, varicose veins are asymptomatic or cause only mild symptoms, but in others they cause pain, aching or itching and can have a significant effect on their quality of life. Varicose veins may become more severe over time and can lead to complications such as changes in skin pigmentation, bleeding or venous ulceration. It is not known which people will develop more severe disease but it is estimated that 3-6% of people who have varicose veins in their lifetime will develop venous ulcers. Health Technology Assessment NHS R&D HTA Programme: Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial) estimated that the prevalence of visible varicose veins in Europe and the USA is approximately 25-30% for adult women and approximately 15% for men. Adherence to NICE Guidance In drafting these guidelines it was noted that NICE CG168 recommends that all symptomatic varicose veins should be referred for investigation and, where appropriate, treatment. Current resources cannot meet the demand that this would generate either in the commissioning costs associated with implementing the NICE pathway, or in the capacity to undertake Doppler examinations etc. These guidelines are intended as a holding position whilst the required pathway and contracting changes have been made to enable seamless adoption of NICE CG168. GM Varicose Veins Policy v2.0 FINAL Page 6 of 17 Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request. Date of Review One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (unless stated this will be every 2 years). When this policy is reviewed all available additional data on outcomes will be included in the review and the policy updated accordingly. Glossary Term Meaning Endothermal Ablation Energy from either from high-frequency radio waves (radiofrequency ablation) or lasers (endovenous laser treatment) is used to seal the affected veins. Exceptionality A person to which the general rule is not applicable (see policy exclusions sections above for a detailed definition). Foam Sclerotherapy The injection of a special foam into the veins, which scars the veins and seals them closed. Varicose Veins Varicose veins are dilated, often palpable subcutaneous veins with reversed blood flow. They are most commonly found in the legs. References 1. Greater Manchester Effective Use of Resources Operational Policy Governance Approvals Name Date Approved Greater Manchester Effective Use of Resources Steering Group v1.0: 17/09/2014 v2.0: 16/03/2016 Greater Manchester Chief Finance Officers / Greater Manchester Directors of Commissioning v1.0: 15/12/2014 v2.0: 14/02/2017 Greater Manchester Association Governing Group v1.0: 06/01/2015 v2.0: 07/03/2017 Bury Clinical Commissioning Group 04/03/2015 Bolton Clinical Commissioning Group 27/03/2015 Heywood, Middleton & Rochdale Clinical Commissioning Group 20/03/2015 Central Manchester Clinical Commissioning Group 05/03/2015 North Manchester Clinical Commissioning Group 13/01/2015 Oldham Clinical Commissioning Group 06/01/2015 GM Varicose Veins Policy v2.0 FINAL Page 7 of 17 Salford Clinical Commissioning Group 06/01/2015 South Manchester Clinical Commissioning Group 11/03/2015 Stockport Clinical Commissioning Group 25/02/2015 Tameside & Glossop Clinical Commissioning Group 22/04/2015 Trafford Clinical Commissioning Group 17/03/2015 Wigan Borough Clinical Commissioning Group 04/03/2015 GM Varicose Veins Policy v2.0 FINAL Page 8 of 17 Appendix 1 – Evidence Review Varicose Veins GM003 Search Strategy The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; BMJ Clinical Evidence; and the relevant royal college websites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below: Database Result NICE (includes NHS Evidence) • • • • NICE CG168: Varicose veins: diagnosis and management NICE IPG8: Radiofrequency ablation of varicose veins (not cited here) NICE IPG52: Endovenous laser treatment of the long saphenous vein (not cited here) NICE IPG440: Ultrasound-guided foam sclerotherapy for varicose veins (not cited here) SIGN SIGN 120: Management of chronic venous leg ulcers - A national clinical guideline (not cited here) Cochrane Cochrane Collaboration: Compression stockings for the initial treatment of varicose veins in patients without venous ulceration, Shingler S et al, The Cochrane library 2011, issue 11 York A systematic review and meta-analysis of the treatments of varicose veins, MH Murad, F Coto-Yglesias, M Zumaeta-Garcia, MB Elamin, MK Duggirala, PJ Erwin, VM Montori, and P Gloviczki., Review published: 2011 BMJ Clinical Evidence BMJ Clinical Evidence Review: Varicose Veins, Paul V Tisi, based on January 2010 search BMJ Best Practice Not undertaken due to number of results found elsewhere. General Search (Google) Gonadal Vein Embolization: Treatment of Varicocele and Pelvic Congestion Syndrome, Mark A. Bittles, M.D.,1 and Eric K. Hoffer, M.D.2 (not cited here) See also GM EUR Pelvic Vein Embolisation in the management of varicose veins policy Medline / Open Athens • • • GM Varicose Veins Policy v2.0 FINAL Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: Short-term results, Lars H. Rasmussen, MD, DMSC, Lars Bjoern, MD, Martin Lawaetz, BS, Allan Blemings, MSc, Birgit Lawaetz, RN, and Bo Eklof, MD, PhD, Naestved and Roskilde, Denmark, 2007 Evidence based clinical practice guidelines: chronic wounds of the lower extremity, American society of plastic surgeons, 2007 (not cited here) Randomised clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial), JA Michaels et al, Health Technology Assessment NHS R&D HTA Programme, April 2006 (not cited here) Page 9 of 17 Evidence listed but not cited has been send to indirectly inform the development of this policy but does not relate directly to the content / criteria. Summary of the evidence There were a lot of evidence reviews and guidelines covering this topic. However, the papers cited within these were often of low quality, i.e. Level 3-5. The evidence Levels of evidence Level 1 Meta-analyses, systematic reviews of randomised controlled trials Level 2 Randomised controlled trials Level 3 Case-control or cohort studies Level 4 Non-analytic studies e.g. case reports, case series Level 5 Expert opinion 1. LEVEL 1: SYSTEMATIC REVIEW NICE CG168: Varicose veins: diagnosis and management NICE carried out a review of the evidence and based their recommendations on the best available evidence whilst acknowledging that a lot more evidence based research was needed. The evidence review for the guideline showed a lack of high quality evidence on the natural progression of varicose veins. It found that the current evidence for the use of compression hosiery was weak and that the evidence for its use after interventional treatment was unclear. It found one small scale study (n=50) on the use and timing of tributary treatment after truncl endothermal ablation. It also found that most of the research into the optimum treatment for varicose veins involved patients at stage C2 and C3 so little is known of the relative efficacies of the treatments at the more severe stages of the disease. 2. LEVEL 1: SYSTEMATIC REVIEW AND META-ANALYSIS A systematic review and meta-analysis of the treatments of varicose veins, MH Murad, F Coto-Yglesias, M Zumaeta-Garcia, MB Elamin, MK Duggirala, PJ Erwin, VM Montori, and P Gloviczki., Review published: 2011 The review found that, based on low quality evidence, available treatments for varicose veins appeared safe and surgery appeared effective long term. Less invasive treatments caused less periprocedural disability and pain but their effectiveness was supported only by short-term studies. These conclusions require some caution in interpretation due to large differences between the included studies. 3. LEVEL 1: SYSTEMATIC REVIEW BMJ Clinical Evidence Review: Varicose Veins, Paul V Tisi, Based on January 2010 search They found 39 systematic reviews, RCTs, or observational studies that met their inclusion criteria. They performed a GRADE evaluation of the quality of evidence for interventions and they presented information relating to the effectiveness and safety of the following interventions: compression stockings, endovenous laser, injection sclerotherapy, radiofrequency ablation, self-help (advice, avoidance of tight clothing, diet, elevation of legs, exercise), and surgery (stripping, avulsion, powered phlebectomy). GM Varicose Veins Policy v2.0 FINAL Page 10 of 17 4. LEVEL 2: RANDOMISED CONTROLLED TRIAL Randomized trial comparing endovenous laser ablation of the great saphenous vein with high ligation and stripping in patients with varicose veins: Short-term results, Lars H. Rasmussen, MD, DMSC, Lars Bjoern, MD, Martin Lawaetz, BS, Allan Blemings, MSc, Birgit Lawaetz, RN, and Bo Eklof, MD, PhD, Naestved and Roskilde, Denmark, 2007 ABSTRACT: Background: Endovenous laser (EVL) ablation of the great saphenous vein (GSV) is thought to minimize postoperative morbidity and reduce work loss compared with high ligation and stripping (HL/S). However, the procedures have not previously been compared in a randomized trial with parallel groups where both treatments were performed in tumescent anesthesia on an out-patient basis. Methods: Patients with varicose veins due to GSV insufficiency were randomized to either EVL (980 nm) or HL/S in tumescent anesthesia. Miniphlebectomies were also performed. Patients were examined preoperatively and at 12 days, and 1, 3, and 6 months postoperatively. Sick leave, time to normal physical activity, pain score, use of analgesics, Aberdeen score, Medical Outcomes Study Short Form36 quality-of-life score, Venous Clinical Severity Score (VCSS), and complication rates were investigated. The total cost of the procedures, including lost wages and equipment, was calculated. Cost calculations were based on the standard fee for HL/S with the addition of laser equipment and the standard salary and productivity level in Denmark. Results: A follow-up of 6 months was achieved in 121 patients (137 legs). The groups were well matched for patient and GSV characteristics. Two HL/S procedures failed, and three GSVs recanalized in the EVL group. The groups experienced similar improvement in quality-of-life scores and VCSS score at 3 months. Only one patient in the HL/S group had a major complication, a wound infection that was treated successfully with antibiotics. The HL/S and EVL groups did not differ in mean time to resume normal physical activity (7.7 vs 6.9 calendar days) and work (7.6 vs 7.0 calendar days). Postoperative pain and bruising was higher in the HL/S group, but no difference in the use of analgesics was recorded. The total cost of the procedures, including lost wages, was €3084 ($3948 US) in the HL/S and €3396 ($4347 US) in the EVL group. Conclusions: This study suggests that the short-term efficacy and safety of EVL and HL/S are similar. Except for slightly increased postoperative pain and bruising in the HL/S group, no differences were found between the two treatment modalities. The treatments were equally safe and efficient in eliminating GSV reflux, alleviating symptoms and signs of GSV varicosities, and improving quality of life. Long-term outcomes, particularly with respect to recurrence rates, shall be investigated in future studies, including the continuation of the present. 5. LEVEL 1: SYSTEMATIC REVIEW Cochrane Collaboration: Compression stockings for the initial treatment of varicose veins in patients without venous ulceration, Shingler S et al, The Cochrane library 2011, issue 11 Background: Compression hosiery or stockings are often the first line of treatment for varicose veins in people without either healed or active venous ulceration. Evidence is required to determine whether the use of compression stockings can effectively manage and treat varicose veins in the early stages. Objectives: To assess the effectiveness of compression stockings for the initial treatment of varicose veins in patients without healed or active venous ulceration. Search methods: The Cochrane Peripheral Vascular Disease Group searched their Specialised Register (last searched 31 May 2011) and CENTRAL (2011, Issue 2). In addition, the reference lists of relevant articles were searched. Authors of ongoing and current trials were contacted. There were no language restrictions. Selection criteria: Randomised controlled trials (RCTs) were included if they involved participants diagnosed with primary trunk varicose veins without healed or active venous ulceration (Clinical, GM Varicose Veins Policy v2.0 FINAL Page 11 of 17 Etiology, Anatomy, Pathophysiology (CEAP) classification C2 to C4). Included trials assessed compression stockings versus no treatment, compression versus placebo stockings, or compression stockings + drug intervention versus drug intervention alone. Trials comparing different lengths and pressures of stockings were also included. Trials involving other types of treatment for varicose veins (either as a comparator to stockings or as an initial non-randomised treatment), including sclerotherapy and surgery, were excluded. Data collection and analysis: Two authors assessed the trials for inclusion and quality (SS and LR). SS extracted the data, which were checked by LR. Attempts were made to contact trial authors where missing or unclear data were present. Main results: Seven studies involving 356 participants with varicose veins without healed or active venous ulceration were included. Different levels of pressure were exerted by the stockings in the studies, ranging from 10 to 50 mmHg. One study assessed compression hosiery versus no compression hosiery. The other six compared different types or pressures of stockings. The methodological quality of all included trials was unclear, mainly because of inadequate reporting. The symptoms subjectively improved with the wearing of stockings across trials that assessed this outcome, but these assessments were not made by comparing one randomised arm of a trial with a control arm and are therefore subject to bias. Meta-analyses were not undertaken due to inadequate reporting and actual or suspected high levels of heterogeneity. Authors’ conclusions: There is insufficient, high quality evidence to determine whether or not compression stockings are effective as the sole and initial treatment of varicose veins in people without healed or active venous ulceration, or whether any type of stocking is superior to any other type. Future research should consist of a large RCT of participants with trunk varices either wearing or not wearing compression stockings to assess the efficacy of this intervention. If compression stockings are found to be beneficial, further studies assessing which length and pressure is the most efficacious could then take place. GM Varicose Veins Policy v2.0 FINAL Page 12 of 17 Appendix 2 – Venous Clinical Severity Score Varicose Veins GM003 Attribute Absent = 0 Mild = 1 Moderate = 2 Severe = 3 Pain None Occasional, not restricting activity or requiring pain medication Daily moderate activity limitation; occasional pain medication Daily, severe limiting activities or requiring regular use of pain medications Varicose Veins None Few scattered Multiple; great saphenous veins, confined to calf and thigh Extensive; thigh and calf or great and small saphenous distribution Venous Edema None Evening ankle swelling only Afternoon swelling, above ankle Morning swelling above ankle and requiring activity change, elevation Skin Pigmentation None Diffuse, but limited in area and old (brown) Diffuse over most of gaiter distribution (lower third) or recent pigmentation (purple) Wider distribution (above lower third) plus recent pigmentation Inflammation None Mild cellulitis, limited to marginal area around ulcer Moderate cellulitis, involves most of (lower third) Severe cellulitis (lower third and above) or significant Induration None Focal, circummalleolar Medial or lateral, less than lower third of leg Entire lower third of leg or more Number of Active Ulcers 0 1 2 >2 Active Ulcer Duration None <3 months >3 months, <1 year Not healed>1 Year Active Ulcer Diameter None <2 2-6 >6 Compression Therapy Not used or patient not compliant Intermittent use of stockings Wears elastic stocking most days Full compliance, stockings + elevation GM Varicose Veins Policy v2.0 FINAL Page 13 of 17 Appendix 3 – Diagnostic and Procedure Codes Varicose Veins GM003 (All codes have been verified by Mersey Internal Audit’s Clinical Coding Academy) GM003 - Varicose Veins Policy Combined operations on primary long saphenous vein L84.1 Combined operations on primary short saphenous vein L84.2 Combined operations on primary long and short saphenous vein L84.3 Combined operations on recurrent long saphenous vein L84.4 Combined operations on recurrent short saphenous vein L84.5 Combined operations on recurrent long and short saphenous vein L84.6 Other specified combined operations on varicose vein of leg L84.8 Unspecified combined operations on varicose vein of leg L84.9 Ligation of long saphenous vein L85.1 Ligation of short saphenous vein L85.2 Ligation of recurrent varicose vein of leg L85.3 Other specified ligation of varicose vein of leg L85.8 Unspecified ligation of varicose vein of leg L85.9 Injection of sclerosing substance into varicose vein of leg NEC L86.1 Ultrasound guided foam sclerotherapy for varicose vein of leg L86.2 Unspecified injection into varicose vein of leg L86.9 Stripping of long saphenous vein L87.1 Stripping of short saphenous vein L87.2 Avulsion of varicose vein of leg L87.4 Local excision of varicose vein of leg L87.5 Transilluminated powered phlebectomy of varicose vein of leg L87.7 Other specified other operations on varicose vein of leg L87.8 Percutaneous transluminal laser ablation of long saphenous vein L88.1 Radiofrequency ablation of varicose vein of leg L88.2 Percutaneous transluminal laser ablation of varicose vein of leg NEC L88.3 Unspecified transluminal operations on varicose vein of leg L88.9 With the following ICD-10 diagnosis code(s): Varicose veins of lower extremities with ulcer GM Varicose Veins Policy v2.0 FINAL I83.0 Page 14 of 17 Varicose veins of lower extremities with inflammation I83.1 Varicose veins of lower extremities with both ulcer and inflammation I83.2 Varicose veins of lower extremities without ulcer or inflammation I83.9 GM Varicose Veins Policy v2.0 FINAL Page 15 of 17 Appendix 4 – Version History Varicose Veins GM003 The latest version of this policy can be found here: GM Varicose Veins policy Version Date Summary of Changes 0.1 23/10/2013 Initial Draft for consideration by GM EUR Steering Group 0.2 10/02/2014 • • 0.3 24/03/2014 Amendments made by GM EUR Steering Group on 19/03/2014: • Criteria for commissioning revised in accordance with GM EUR Steering Group recommendations. • Removal of “Varicose Vein Referral Threshold Tool” – Appendix 2 • Inclusion of “GM013 Benign Skin Lesion EUR Policy” under section 12 links to other policies. 0.4 08/04/2014 • • 0.5 Appendix 2 added “Varicose Vein Referral Threshold Tool” Thread veins and Spider Naevus/Telangiectasia are included within the GM013 Dermatology Minor Surgery policy inserted in policy exclusions section. Statement regarding treating disabled people as more equal than other protected characteristic groups added to Equality and Equity section. Ratification through CCG Governing Bodies added to ‘Governance Arrangements’. 28/05/2014 Amendments made by GM EUR Steering Group on 21/05/2014: • Aberdeen Score changed to Venous Clinical Severity Score. • The first 2 bullet points in the mandatory criteria should be specified as an urgent referral. • Reference to NICE 168 guidance further defined, and includes an explanation of why the policy does not fully comply with NICE guidance. • Appendix 2: Venous Clinical Severity Score added. • Draft policy approved for consultation following the above amendments. • Policy published for consultation from 09/07/2014 to 03/09/2014. 09/07/2014 Feedback from consultation reviewed by the GM EUR Steering Group. amendments required. 17/09/2014 Policy approved by GM EUR Steering Group. 0.6 08/10/2014 Branding Changed following creation of North West CSU on 01/10/2014. 1.0 17/09/2014 Policy approved by GM EUR Steering Group. 1.1 27/03/2015 Bolton CCG adopted funding mechanism of IPA for all requests. 23/06/2015 • • Variance column removed and funding mechanism column added to table. Format of funding mechanism changed. 05/04/2016 • List of diagnostic and procedure codes in relation to this policy added as Appendix 3. Policy changed to Greater Manchester Shared Services template and references to North West Commissioning Support Unit changed to Greater Manchester Shared Services. 1.2 • GM Varicose Veins Policy v2.0 FINAL No Page 16 of 17 19/04/2016 • • Funding mechanism for Bolton CCG changed from Individual Prior Approval for all requests to Monitored Approval for severe varicose veins and Individual Prior Approval for moderate varicose veins – in line with the rest of GM. Wording for date of review amended to read “One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (unless stated this will be every 2 years)” on ‘Policy Statement’ and section ‘13. Date of Review’. 1.3 13/06/2016 Wigan CCG changed funding mechanism to Individual Prior Approval (IPA) for severe varicose veins – to be adopted from 1st August 2016. 2.0 18/05/2016 The GM EUR Steering Group reviewed the policy and the following changes were made: • 'Severe Varicose Veins' section reworded as follows: "All patients should be given advice on lifestyle changes, exercise and skin care. Secondary care referral and management is commissioned for the following: Urgent Referral for Bleeding • They are bleeding from a varicosity. • They have bled from a varicosity and are at risk of bleeding again. Severe Varicose Veins Referral to a vascular service for patients with severe varicose veins – these are varicose veins that are associated with any one of the following: • They have an ulcer which is progressive and/or painful. • They have recurrence of an ulcer • They have an ulcer which has failed to respond to 12 weeks or more of active treatment or is deteriorating despite treatment • Progressive skin changes indicative of venous disease that may benefit from surgery." • First paragraph under 'Moderate Varicose Veins' sub-heading removed and replaced with: "Patients with: • Atrophy blanche with hemosiderin deposition. • Extensive tortuous varicose veins of the whole lower limb (indicative of long saphenous insufficiency) who would be considered at high risk of bleeding from minor external trauma. Referral for the moderate group is via the IFR route for prior approval" • Sub-heading added for clarity: ‘Secondary Care Management’ 14/02/2017 Reviewed policy approved by GM CFOs / GM DOCs 07/03/2017 Reviewed policy approved by GM AGG 08/03/2017 • • Policy transferred to new template format. Wording in 'Search Strategy' section in Appendix 1 amended for clarity GM Varicose Veins Policy v2.0 FINAL Page 17 of 17