Enclosure 08 - NHS North Staffordshire

September 2009 – Enclosure 08 Report to the Board of Directors DATE OF MEETING REPORT TITLE REPORT SUBMITTED BY RECOMMENDATION(S) Thursday 17 September 2009 Low Priority Treatments – Commissioning Policy Dr Judith Bell, Director of Public Health The Board of Directors is requested to: 1. Approve the Low Priority Treatments – Commissioning Policy 1 1.1 Introduction The purpose of this report is to present an updated Low Priority Treatment Policy to the Board of Directors for their approval . The purpose of the Low Priority Treatment Policy is to clarify the commissioning intentions of NHS North Staffordshire in respect of treatments that are excluded from current Service Level Agreements on the grounds of limited clinical value. It supersedes the existing PCT policy. The PCT has had a policy in place since 2006. This document revises and strengthens the overall policy framework including managing and monitoring the implementation. A revised schedule of procedures is set out in appendix 1. Methodology Evidence has been reviewed by public health from a range of sources e.g. Cochrane Institute to support the development of the schedule. The Commissioning Priorities Advisory Group has led the work which has been considered by the Clinical Executive Committee and Practice Based Commissioners. Discussion The policy will require to be underpinned by effective implementation including equipping primary care staff, primarily GPs with the right information and also a systematic process for monitoring adherence with the policy. 1.2 2 2.1 2.2 3 3.1 1 4 4.1 4.2 Impact Assessment In terms of the Strategic Plan then this supports NHS North Staffordshire to disinvest in interventions which bring limited benefit to the population. Risk There is the risk that the policy will be challenged and that implementation will be ineffective. Resources Resources are required to update and maintain the policy, monitor it and also supply primary care with the information required. Training Nil Equality and Diversity The policy seeks to ensure resources are directed away from ineffective care and does not have impacts on equality and diversity. Effects on other areas of PCT business or policy The policy effects provider contract management, primary care contractor management and will require support from the performance team in monitoring. Recommendations The Board of Directors is requested to: Approve the Low Priority Treatments – Commissioning Policy 4.3 4.4 4.5 4.6 5 5.1 5.2 Dr Judith Bell Director of Public Health 2 Commissioning Policy for Low Priority Treatments Policy Folder & Number: Version: Ratified By: Date Ratified: Name & Title of Originator: Name of Responsible Board / Committee for Ratification: Date Issued: Review Date: Target Audience: V2.1 John Harvey interim Consultant Public Health Medicine North Staffordshire PCT Board of Directors Providers, including primary care, commissioners and 3 1. Purpose The purpose of the Low Priority Treatment Policy is to clarify the commissioning intentions of NHS North Staffordshire in respect of treatments that are excluded from current Service Level Agreements on the grounds of limited clinical value. It supersedes the existing PCT policy. 2. Introduction This Policy has been developed to support the decision making process associated with the allocation of resources for commissioning. It will be used to support the development of effective, efficient and ethical Service Level Agreements with provider organisations, and the procurement of interventions on an exceptional basis. The Policy establishes the framework within which NHS North Staffordshire can demonstrate that its decision making processes are fair, equitable, ethical and legally sound. 3. Background Primary Care Trusts (PCTs) receive the funding to commission health services for their resident population and make decisions within the context of statutes, statutory instruments, regulations and guidance. PCTs have a responsibility to seek the greatest health advantage possible for local populations using the resources allocated to them. They are required to commission comprehensive, effective, accessible services which are free to users at the point of entry (except where there are defined charges) within a finite resource. It is, therefore, necessary to make decisions regarding the investment of resources in interventions which achieve the greatest health gain for the population. This Policy is designed to help NHS Staffordshire to meet this obligation in providing equitable access to health care. It aims to achieve this by supporting a robust decision making process that is reasonable and open to scrutiny. 4. Definition of “Low Priority Treatments” The term “treatment” describes clinical care and programmes of care that include:• medicines • surgical procedures • therapeutic and other healthcare interventions On systematic evaluation, some interventions have been identified as being either marginally effective or ineffective with limited clinical value - in the vast majority of cases. Others have been shown to be an inefficient use of resource given their high cost per quality adjusted life year gained. Such interventions shall be considered and commissioned on an exceptional basis only under the policy for Individual Funding Requests (IFR Policy). 5. 5.1 Operating Policy for the development and implementation of this Policy Scope A number of national and local organisations, such as NICE, have developed evidence-based advice to inform commissioning decisions on low priority treatments. These treatments or procedures are not usually funded by the NHS. In addition NHS North Staffordshire has responsibility to decide the priorities for commissioning in line with agreed criteria. The IFR policy defines the concept of „exceptionality‟ where an individual case is under consideration. 5.2 Making commissioning decisions Commissioning involves specifying, securing and monitoring services that are evidence-based, cost effective, of high quality and meet individuals‟ needs and provide “value for money in the use of public resources”. The Commissioning Priority Advisory Group makes recommendation to the Board taking into account the views of the Clinical Executive Committee (CEC) and Practice based Commissioners (PBC). 5.3 Managing Exceptions Requests for individual funding will be considered under the procedures laid out in the IFR policy. Central to the consideration of individual cases is the concept of the case being exceptional. The definition of exception is within the IFR Policy and explicit criteria are stated in the IFR policy: i. ii. iii. the request does not in fact seek to introduce a new treatment for a definable group of patients however small; the patient is significantly different to the general population of patients with the condition in question; the patient is likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition. Determining the Evidence Base. 5.4 Evidence for treatment effectiveness and efficacy is available from many sources, including NICE, the Cochrane Institute, Royal Colleges and other professional guidelines, and sources such as peer reviewed journals or technical notes. Evidence varies in its robustness, ranging from meta-analyses of randomised control trials with large populations of participants, to traditional consensus about best practice. NHS Staffordshire considers the source, extent and quality of the evidence in reaching their decisions. The process is led by the Commissioning Priorities Advisory Group. 5.5 Ethical and Legal Policy for decision making The PCT has a Prioritisation Framework which is kept under review. -5- 5.6 Implementation 5.6.1 The schedule of low priority treatments The schedule is set out in appendix 1.This can be incorporated into contractual and service level agreements. NHS North Staffordshire will require primary and secondary care service providers to embrace and abide by the policy and advise patients accordingly. Clinicians should adhere to the process for handling a patient‟s individual needs set out in the IFR policy. 5.6.2 Distribution Providers including primary care and commissioners. 5.7 Monitoring the policy NHS North Staffordshire will monitor the adherence to this policy through the Directorate of Quality and Performance and contract management will be led by the Directorate of Commissioning and Service Redesign. The numbers of breaches of the policy by procedure will be reported monthly. Where there are defined thresholds, the compliance with the criteria will be subject to regular clinical audits. The Executive Directors and PBC will receive a quarterly report. 5.8 Maintaining an up-to-date policy NHS Staffordshire will abide by this policy when making decisions relating to the provision of low priority treatments. Specifically, the role of the PCT is to:     monitor the implementation of the policy and the impact it has on clinical decision making; inform referrers including all Primary Care Practices and Dental Practices of the Policy; inform all service providers with whom the PCT has formal contractual arrangements of the Policy; review the policy and the accompanying schedule on an annual basis or where an urgent consideration of new evidence is justified. -6- Appendix 1 Low priority procedures (Exclusions) Schedule The following procedures are not funded by NHS North Staffordshire on a routine basis. In exceptional cases a provider can request Commissioners to fund specific cases on an individual basis in accordance with the Policy for Individual Funding Requests. The OPCS codes given in this document are for guidance and information for clinical coding purposes. The column headed „status‟ identifies whether the procedure is completely excluded or it is restricted to those conditions in the approved thresholds column. Items in BLUE are new additions to the policy. OPCS codes S021, S022, S028, S029 D031, D032, D033, D038, D039, D062 Procedures Abdominoplasty / Apronectomy Cosmetic operations on external ear: Pinnaplasty (Bat Ears) Split earlobes Others Blepharoplasty Approved indications or thresholds None For children under age of 16 years: with evidence of congenital earlobe deformity and substantial psychological distress, severe bullying at school. status excluded restricted C131, C132, C133, C134, C138, C139, C161, C162, C163, C164, Only proven visual field impairment (reducing visual field to 120o laterally and 40o vertically). For upper lids only. restricted 7 OPCS codes C165, C168, C169 S601, S602, S603 B301, B302, B308, B309, B311, B312, B313, B314, B318, B319, S482 Procedures Approved indications or thresholds status Tattoo removal Cosmetic operations on breast: a) Breast Augmentation b) Breast Reduction c) Mastopexy d) Others Skin procedures: A. Treatment for lipomata, sebaceous cysts, skin tags or other minor skin lesions, including those listed below: 1) milia 2) asymptomatic seborrhoeic keratoses 3) asymptomatic warts of hands and feet (except if interfering with mobility and employability or if immunosuppressed) 4) unchanging or asymptomatic benign melanocytic naevi 5) skin tags None. a) following mastectomy, post-burns breast asymmetry, following prophylactic bilateral mastectomy for cancer prevention in high risk cases, b) none c) none A. Where there is a risk of malignancy excluded a) restricted b) excluded c) excluded S051, S052, S053, S054, S055, S058, S059, S061, S062, S063, S064, S065, S068, S069, S081, S082, S083, S088, S089, S091, S092, S093, S098, S099, S101, S102, S103, S104, S108, S109, S111, S112, S113, S114, S118, S119 A excluded 8 OPCS codes Procedures Approved indications or thresholds status 6) corns 7) physiological androgenetic alopecia 8) physiological idiopathic hirsutes with a normal menstrual cycle 9) asymptomatic dermatofibromata 10) asymptomatic fungal infections of toe nails 11) telangiectasiae and spider naevi (except if occurring on the face of a child who is being teased or bullied) 12) comedones 13) tattoos 14) asymptomatic lipomata 15) asymptomatic epidermal cysts (sebaceous cysts) 16) molluscum contagiosum 17) mild or moderate non scarring acne vulgaris which has not been treated with 6 months of systemic therapy B. Congenital vascular C. abnormalities None – if for cosmetic purposes only C. Lasers and other cosmetic skin procedures in plastic surgery B Excluded C Excluded 9 OPCS codes S604 Procedures Scars and keloids Approved indications or thresholds For scars that interfere with function following burns/trauma, serious scarring of the face and severe post-surgical scarring. following facial paralysis. status restricted S011, S012, S013, S014, S015, S016, S018, S019 S031, S032, S033, S038, S039 S622 E021, E022, E023, E024, E025, E026, E027, E028, E029 N281, N282, N283, N284, N285, N286, N288, N289, N291, N292, N298, N299, P011, P012, P018, P019, P055, P056, P057, P153 L68 C12.1 Cosmetic excision of skin of head or neck: e.g. Face lift Buttock lift Thigh/arm contouring Liposuction Cosmetic operations on nose: e.g. Rhinoplasty restricted none none For post-traumatic conditions with airways obstruction and post-surgical complications, such as saddle nose. none excluded excluded restricted Aesthetic / cosmetic genital surgery excluded Hair depilation surgery in adults for lid lumps none potentially malignant; infected; symptoms of pain, irritation, discomfort; functional deficit; lid malposition; interfere with vision; recurrent nuisance excluded restricted 10 OPCS codes C493, C498, C499 Procedures Laser treatment of myopia (short-sightedness) screening for diabetic retinopathy by consultant ophthalmologists screening for glaucoma by consultant ophthalmologists cataract surgery Approved indications or thresholds none status excluded none excluded none Threshold is visual acuity of 6/12 in the worst eye. 1. Patients who are still working in an occupation in which good acuity is essential to their ability to continue to work (e.g. watchmaker) 2. Patients with posterior subcapsular cataracts and those with cortical cataracts who experience problems with glare and a reduction in acuity in bright conditions 3. Driving: the legal requirement for driving falls between 6/9 and 6/12 (strictly speaking it is based on the number plate test). It is anticipated that the threshold will not render the majority of people unable to drive as it applies to the worst eye only. Exceptions will be considered for: * Patients who need to drive who experience significant glare which affects driving; * Patients who, for occupational reasons, need to drive at night and who experience glare that is related to cataract; * Patients with visual field defects excluded restricted C711, C712, C713, C718, C719, C721, C722, C723, C728, C729, C731, C732, C733, C734, C738, C739, C741, C742, C743, C748,C749, C751, C752, C753, C754, C758, C759 HRG: B13 11 OPCS codes Procedures Approved indications or thresholds borderline for driving, in whom cataract extraction would be expected to significantly improve the visual field. 4. Patients with glaucoma who require cataract surgery to control intra ocular pressure 5. Patient with diabetes who require clear views of their retina to look for retinopathy Cataract Second Eye 1. Where the cataract procedure on the first eye has achieved a VA of 6/9 or better, and the VA for the second eye is 6/12 or better, then the patient should be discharged, unless receiving treatment for any other eye condition. The patient should be advised to attend an optometrist for a sight test annually or earlier if they notice any deterioration of vision. 2. If the first eye does not achieve a VA of 6/9 or better, then the second eye should be dealt with on clinical merit, taking into account any directly related work circumstances (i.e. the requirement for night driving). 3. There are circumstances, where despite good acuities, there may still be a clinical need to operate on the second eye fairly speedily e.g. where there is resultant anisometropia (a large refractive difference between the two eyes) which would result in poor binocular vision or even diplopia. In status 12 OPCS codes Procedures Approved indications or thresholds these circumstances, the notes should clearly record this so that it can be identified during any future clinical audit. status L841, L842, L843, L844, L845, L846, L848, L849, L851, L852, L853, L858, L859, L861, L862, L868, L869, L871, L872, L873, L874, L875, L876, L877,L878, L879, L881, L882, L883, L888, L889 Surgical treatment of uncomplicated varicose veins and reticular veins or telangiectasia. Obvious skin changes including varicose eczema; Ulceration; Recurrent phlebitis (_2 episodes); Bleeding from a varicose vein; Patient has severe symptoms attributable to the venous disease (significant and persistent aching, discomfort or oedema) requiring analgesia and has not responded to the regular use of compression hosiery for a period of six months. Patients with a BMI of ≥ 50kg/m who have undertaken and failed to achieve any significant weight reduction following lifestyle and pharmacological intervention. Symptomatic phimosis or paraphimosis; and recurrent balanitis or balanoposthitis. none 2 restricted G30.1,30.2,30.3,30.4, 30.8,30.9 restricted Bariatric Surgery (Gastroplasty; Gastric banding; other specified or unspecified plastic operations on the stomach) N303 Circumcision restricted H482 Surgery for anal/rectal skin tags excluded 13 OPCS codes Procedures Approved indications or thresholds none status J181, J182, J183, J184, J185, J188, J189, J211, J212, J213, J218, J219 Surgery for asymptomatic gallstones (Asymptomatic gallstones are usually diagnosed incidentally when they are seen on imaging which is done for some unrelated reasons.) excluded H221, H228, H229, H251, H258, H259, H281, H288, H289 Investigations for patients under 45 years who have had a single bright red rectal bleed investigation rectal bleed haemorrhoidectomy none excluded N181, Q291, Q292, Q298, Q299, Q371, Q378, Q379 Q131, Q132, Q133, Q134, Q135, Q136, Q137, Q138, Q139, Q383 Reversal of sterilisation: reversal of vasectomy or reversal of tubal ligation Initial consultation and investigations Semen analysis (except after vasectomy) In Vitro Fertilisation (IVF) Intrauterine Insemination (IUI) Intracytoplasmic Sperm Injection (ICSI) Donor Insemination (DI) Egg (Oocyte freezing) patients referred with intermittent bright red rectal bleeding should be investigated and treated for piles recurrent and persistent bleeding that fails to respond to conservative treatment; haemorrhoids cannot be reduced none restricted restricted excluded None excluded Requests for young women with cancer who have no children should go through the patient escalation process 14 OPCS codes Procedures Surgical Sperm Recovery Embryo Freezing Assisted Hatching Blastocyst Transfer Egg Sharing and Donation Ovarian Reserve Testing Vasectomy Reversal Subfertility services Approved indications or thresholds status N341, N342, N343, N344, N345, N346, N348, N349, Q561 Q103, Q108, Q109, Q181, Q188, Q189 None excluded Dilatation and curettage As a diagnostic tool or as a therapeutic treatment for menorrhagia none excluded Q071, Q072, Q073, Q074, Q075, Q076, Q078, Q079, Q081, Q082, Q083, Q088, Q089 Hysterectomy for menorrhagia As a first line treatment, there has been a prior trial with a levonorgestrelreleasing intrauterine system (LNGIUS), and it has failed to relieve symptoms or is not appropriate or contraindicated. AND There has been a prior trial using second line pharmaceutical treatment with either tranexamic acid, nonsteroidal anti-inflammatory agents or other hormone methods (combined oral contraceptives, progestogens, Gn-RH analogue) in line with NICE guidance, and it has failed to relieve symptoms or is not appropriate or contraindicated. AND Surgical treatments such as restricted 15 OPCS codes Procedures Approved indications or thresholds endometrial ablation, uterine-artery embolisation, or myomectomy have been offered and failed to relieve symptoms or are not appropriate or are contra-indicated. international prostate symptom score >7; dysuria; post voided residual vol >150ml; recurrent UTI; deranged renal function; PSA > age adjusted normal values. none none status M61-62, M65 Surgery for prostatism restricted N32.4 Reversal of sterilisation: reversal of vasectomy Drug treatment for erectile dysfunction – injection of therapeutic substance into penis Vasectomies in secondary care settings Tonsillectomy excluded excluded N171, N172, N178, N179 F341, F342, F343, F344, F345, F346, F347, F348, F349 Where clinical circumstances prevent treatment in Primary Care. 1. In children and adults with sore throats that are due to tonsillitis and are severely affected by recurrent attacks of acute tonsillitis (RAAT), defined as – More than 6 documented episodes of RAAT in the preceding year, or More than 3 documented episodes of RAAT in each of the preceding two years. restricted restricted 16 OPCS codes Procedures Approved indications or thresholds Each of the episodes must be documented in the patient‟s notes and characterised by at least one of the following: a. Oral temperature of at least 38.3 C b. Tender anterior cervical lymph nodes c. Tonsillar exudates d. Positive culture of group A beta haemolytic streptococci e. The episodes are disabling and prevent normal functioning (school / work) f. Tonsillar enlargement giving rise to symptoms of obstruction (Recurrent attacks are a succession of definite episodes, as opposed to chronic tonsillitis) 2. In teenagers and adults with – a. Severe halitosis which has been demonstrated to be due to tonsil crypt debris (diagnosed by the ENT surgeons) 3. Unequivocal indications for tonsillectomy – a. Peri-tonsillar abscess (Quinsy) b. Acute upper airways obstruction c. Tonsillar swelling is interfering with swallowing and is causing dehydration and marked systemic upset d. Suspected tonsillar malignancy – refer under 2 week wait e. Upper airways obstruction causing sleep apnoea, daytime somnolence and failure to thrive f. Chronic tonsillitis, characterised by status 17 OPCS codes Procedures Approved indications or thresholds constant sore throat, cervical lymphadenopathy, intermittent fever and peri-tonsillar erythema. This is more common in adults than children (Immediate referral (same day) is recommended for 3a, 3b and 3c) status D151, D158, D159, D202, D203 Grommets 1.Had frequent episodes of acute otitis media (6 over the previous 12 months) Or restricted Surgery for snoring (Uvulopalatopharyngoplasty) 2. Had a period of at least six months watchful waiting from onset of symptoms And 3. One or more of the following criteria for referral and surgery have been applied The child has persistent hearing loss detected on two occasions separated by 3 months or more* The child has proven hearing loss, plus difficulties with speech and language (expressive language delay), cognition, behaviour and education attributable to persistent hearing loss; which have lasted for 6 months from the beginning of the problem The child has proven hearing loss, plus a second disability such as Down‟s Syndrome or cleft palate. none excluded 18 OPCS codes Procedures Sleep Apnoea (Obstructive Sleep Apnoea) Approved indications or thresholds patients with co-morbidity; occupations with increased risk; people whose employment requires holding category B driving license. Pts should have symptoms of EDS and witnessed sleep apnoea evidence that conservative means have failed to alleviate pain and disability Salisbury score =14 Oxford score >36/60 acute severe symptoms uncontrolled by conservative measures, particularly in pregnancy; chronic mild to moderate symptoms not responding to 4 months conservative management; neurological deficit. status restricted W37-39, W40-42 hip and knee replacement restricted A65.1 carpal tunnel syndrome restricted T59,60 Ganglia surgical removal, ganglion on wrist surgical removal,seed ganglia at base of digits surgical removal mucoid cysts at DIP joint evidence of neurovascular compromise significant pain restricted restricted restricted restricted T52.1 Dupuytren's Disease - palmar fasciectomy T72.3 trigger finger treatment – surgical nail growth disturbed, cysts tend to discharge pt has loss of extension in one or more joints exceeding 25 degrees; pt under 45 with >10 degree loss extension in 2 or more joints; evidence of proximal interphalangeal joint contracture. failure to respond to conservative measures; fixed deformity noncorrectable. restricted 19 OPCS codes V37-39 Procedures spinal fusion Approved indications or thresholds unequivocal root compression; spinal stenosis; instability; failure of adequate conservative trial of >6 months duration For low back pain - single injection for pts who might have undergone discectomy sciatica - where patient responded previously as diagnostic/screening tool prior to radiofrequency denervation or surgery in order to show probability of benefit; as treatment where co-morbidities that preclude other interventions patient has mechanical features of locking that are associated with severe pain none status restricted restricted restricted restricted A 52 spinal epidural injections V54.4 facet joint injections for back pain W85.2, 85.8 knee osteoarthritis debridement W87.9 diagnostic arthroscopy of knee U133 and Z67 plain Xray and MRI of back W90.3 joint injections - restricted excluded restricted restricted red flag symptoms Suspected osteoporotic fracture restricted if patient candidate for joint replacement in 6-12 months: as diagnostic tool prior to joint replacement to confirm joint as source of symptoms or for patients unfit or unsuitable for surgery. Not commissioned in sterile theatre unless xray screening or gen anaesthesia required AND where performed in combination with other procedures evidence of trial of conservative treatment; temporary improvement demonstrated using injection surgery W57.2 +Z86.1, W08.5+Z86.1 excision acromioclavicular joint; surgical decompression restricted 20 OPCS codes Procedures subacromial space therapeutic ultrasound in physiotherapy Approved indications or thresholds none for the following Grades on the Index of Treatment Need (IOTN): IOTN 3 with an Aesthetic Component of 6+ (6 or more) IOTN 4 and IOTN 5 post cancer reconstruction; major trauma with bone loss; anadontia None If meet Faculty of Dental Surgery guidelines LVEF<35%; drug refractory symptoms; QRS duration>120ms none evidence severe stenosis or bilateral stenosis and low surgical risk when asymptomatic or mild to moderate symptoms; severe symptoms and significant stenosis should be treated asap none none none status excluded restricted F141, F142, F143, F144, F145, F148, F149, F151, F152, F153, F154, F155, F156, F157, F158, F159 orthodontics F11.5 F09.1, F09.3 F12.1 Dental implants Removal of asymptomatic wisdom teeth Apicectomy bi-ventricular pacing for heart failure spinal cord stimulation for chronic pain carotid endartectomy for carotid stenosis restricted excluded restricted excluded restricted propentofylline/pentoxifylline borderline personality disorder therapeutic community chronic fatigue syndrome excluded excluded excluded 21 OPCS codes Procedures inpatient cognitive behavioural therapy cholinesterase inhibitors routine Doppler ultrasound of umbilical + uterine artery in low risk pregnancies Gender reassignment Paroxysmal Nocturnal Haemaglobinuria Prophylaxis to reduce RSV and associated morbidity and mortality in infants Complementary medicines/therapies Approved indications or thresholds Alzheimer's disease with mini Mental score of 10-20 if consistent with NICE guidance none status restricted excluded X151, X152, X153, X158, X159 Eculizumab Palivizumab none none Children with chronic lung disease or congenital heart disease born at less than 30 weeks gestation and who are less than 6 months old Homeopathy is not funded Acupuncture will only be funded as an adjunct to pain management and only through specialist pain clinics. Osteopathy and chiropractic therapy is not funded excluded excluded restricted X611, X612, X613, X614, X618, X619 restricted 22