Betsi Cadwaladr University Local Health Board ... - Health in Wales
Betsi Cadwaladr University Local Health Board ... - Health in Wales
Betsi Cadwaladr University Local Health Board ... - Health in Wales
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<strong>Betsi</strong> <strong>Cadwaladr</strong> <strong>University</strong> <strong>Local</strong> <strong>Health</strong> <strong>Board</strong><br />
Individual Patient Commission<strong>in</strong>g<br />
Standard Operat<strong>in</strong>g Procedure<br />
Authors: Dr Mart<strong>in</strong> Duerden<br />
Medical Director Conwy - BCUHB<br />
Dr Fraser Campbell<br />
Medical Director Gwynedd - BCUHB<br />
Dr Medwyn Williams<br />
Medical Director Anglesey - BCUHB<br />
Mr Damian Heron Director<br />
North <strong>Wales</strong> Cancer Network<br />
Dr Matthew Mak<strong>in</strong> Chief of Staff<br />
Cancer CPG<br />
Dr Rob Atenstaedt<br />
Consultant <strong>in</strong> Public <strong>Health</strong> Medic<strong>in</strong>e<br />
Public <strong>Health</strong> <strong>Wales</strong><br />
Mr Andrew Jones<br />
Director of Public <strong>Health</strong><br />
BCUHB<br />
Based upon: Previous ECR/NCA policies for<br />
Anglesey LHB<br />
Conwy LHB<br />
Denbigh LHB<br />
Gwynedd LHB<br />
Fl<strong>in</strong>tshire LHB<br />
Wrexham LHB<br />
Date : February 2010<br />
Review Date: March 2011<br />
Approved by: BCU LHB <strong>Board</strong>
INDEX OF CONTENTS<br />
SECTION DESCRIPTION PAGE<br />
1 Introduction & Def<strong>in</strong>itions 3-5<br />
2 Legal & Ethical Framework 5-8<br />
3 Fund<strong>in</strong>g Application Procedures 9-14<br />
4 Child Protection Issues 14<br />
5 Entitlement of Patients to Treatment Overseas 15<br />
6 Appeals Process 16-18<br />
7 Audit, Monitor<strong>in</strong>g and Review Arrangements 18<br />
8 Communication Strategy 19-20<br />
Appendix 1 Low Effectiveness Procedures (LEPs) 21<br />
Appendix 2 Application Request Proforma 60<br />
Appendix 3 IPC Panel Checklist 64<br />
2
Section 1 - Introduction and Def<strong>in</strong>itions<br />
1.1 <strong>Betsi</strong> <strong>Cadwaladr</strong> <strong>University</strong> <strong>Local</strong> <strong>Health</strong> <strong>Board</strong> is responsible for the<br />
management of <strong>in</strong>dividual patient specialist requirements, not dealt with under the<br />
normal referral routes via primary or secondary care. Process and criteria must be<br />
consistently adopted and adhered to across the <strong>Local</strong> <strong>Health</strong> <strong>Board</strong> to facilitate<br />
decisions follow<strong>in</strong>g requests made by appropriate cl<strong>in</strong>icians and manage and monitor<br />
the <strong>in</strong>dividual cases.<br />
1.2 The priorities for modernis<strong>in</strong>g the NHS should be underp<strong>in</strong>ned by the careful<br />
management of overall NHS resources to ensure people have access to high quality<br />
services and care, regardless of where they live. Consequently, the <strong>Local</strong> <strong>Health</strong><br />
<strong>Board</strong> needs to cont<strong>in</strong>uously improve the cost effectiveness of the services provided,<br />
thereby secur<strong>in</strong>g the greatest health ga<strong>in</strong> from the resources available. In order to<br />
achieve this, fund<strong>in</strong>g decisions on <strong>in</strong>dividual patient services should be based on<br />
evidence of both the cl<strong>in</strong>ical effectiveness of services, together with an exam<strong>in</strong>ation<br />
of the impact of specific high cost services or treatments on the wider ability to deliver<br />
care for the whole community.<br />
1.3 Each case will be dependent on assessment of its own merits, <strong>in</strong> accordance<br />
with the criteria of the LHB. It is therefore necessary for the LHB to develop and<br />
ma<strong>in</strong>ta<strong>in</strong> a clear, transparent and explicit mechanism to assist <strong>in</strong> the decision mak<strong>in</strong>g<br />
process for these cases.<br />
1.4 The mechanism <strong>in</strong> place must ensure that, where possible, decisions are<br />
made quickly to enable patients and referr<strong>in</strong>g cl<strong>in</strong>icians to either implement proposals<br />
or f<strong>in</strong>d alternatives to requests where the application does not receive a positive<br />
outcome. However, the onus is on the referr<strong>in</strong>g cl<strong>in</strong>ician to ensure sufficient<br />
<strong>in</strong>formation regard<strong>in</strong>g a particular request is made available to avoid unnecessary<br />
adm<strong>in</strong>istrative delay.<br />
1.5 This procedure presents the approach to be adopted by the <strong>Betsi</strong> <strong>Cadwaladr</strong><br />
<strong>University</strong> <strong>Local</strong> <strong>Health</strong> <strong>Board</strong> <strong>in</strong> receiv<strong>in</strong>g and consider<strong>in</strong>g requests for fund<strong>in</strong>g of<br />
patient treatments/services that fall with<strong>in</strong> the follow<strong>in</strong>g categories:<br />
• Extra Contractual Referrals (ECR);<br />
• Non Contracted activity (NCA);<br />
• Named Patient Contracts (NPC);<br />
• Named Patient Variations (NPV)<br />
• Low Effectiveness Procedures (LEPs)<br />
• High Cost Drugs<br />
• Entitlement of Patients to Treatments Overseas<br />
1.6 All these categories of treatments and services would be funded from current<br />
<strong>Local</strong> <strong>Health</strong> <strong>Board</strong> revenue and thus represent an <strong>in</strong>-year f<strong>in</strong>ancial risk to the LHB.<br />
1.7 Under the new proposals for the plann<strong>in</strong>g and commission<strong>in</strong>g of tertiary<br />
services, fund<strong>in</strong>g of specialist procedures previously managed by <strong>Health</strong> Commission<br />
<strong>Wales</strong> (HCW) will transfer to the LHB and be adm<strong>in</strong>istered by the new national<br />
3
arrangements for specialist commission<strong>in</strong>g under the Welsh <strong>Health</strong> Specialised<br />
Services Committee (WHSSC). However, as these arrangements have not yet been<br />
f<strong>in</strong>alised, it is assumed that any fund<strong>in</strong>g requests for services currently commissioned<br />
by HCW will cont<strong>in</strong>ue to be processed by HCW. This will be until such time that the<br />
new arrangements for tertiary services are <strong>in</strong> place at which po<strong>in</strong>t this procedure will<br />
be amended accord<strong>in</strong>gly.<br />
Extra Contractual Referrals (ECR)<br />
1.8 Treatments or Services provided by an <strong>in</strong>dependent or private health service<br />
provider are termed extra contractual referrals or ECR.<br />
Non Contracted Activity (NCA)<br />
1.9 Treatments or Services provided by other NHS organisations with which the<br />
<strong>Local</strong> <strong>Health</strong> <strong>Board</strong> does not hold an exist<strong>in</strong>g Long Term Agreement (LTA) or<br />
contracts, are termed non contracted activity or NCA.<br />
1.10 Elective and non emergency NCAs need prior authorisation from the LHB and<br />
should be considered on an <strong>in</strong>dividual case by case basis. However, emergency or<br />
immediately necessary treatments do not need prior authorisation from the LHB and<br />
although these tend to be low volume, they are funded from current LHB revenue and<br />
so therefore present an <strong>in</strong>-year f<strong>in</strong>ancial risk for the LHB.<br />
Named Patient Contacts (NPC)<br />
1.11 Treatments or Services by an NHS organisation which is prepared to provide a<br />
specific treatment/service outside the normal LHB contracts are termed Named<br />
Patient Contacts or NPC. This mechanism may be used where a provider is<br />
unwill<strong>in</strong>g, or it is <strong>in</strong>appropriate, to use the NCA process because of high and/or<br />
variable costs <strong>in</strong>volved. This will often apply to specialised services or new services<br />
be<strong>in</strong>g offered by the NHS organisation.<br />
Named Patient Variations (NPV)<br />
1.12 Treatments or Services by an NHS organisation which are variations to an<br />
exist<strong>in</strong>g LTA or contract and which may <strong>in</strong>volve additional fund<strong>in</strong>g to support<br />
enhanced service levels/treatments to <strong>in</strong>dividual patients are termed Named Patient<br />
Variations (NPV)<br />
Low Effectiveness Procedures (LEPs)<br />
1.13 Appendix 1 lists cl<strong>in</strong>ical <strong>in</strong>terventions of limited or unknown cl<strong>in</strong>ical value.<br />
These <strong>in</strong>terventions are rout<strong>in</strong>ely considered to be of low priority and are not normally<br />
used by the NHS. These <strong>in</strong>terventions have been split between those that should not<br />
be used <strong>in</strong> any circumstance and those that should not be used except under strict<br />
criteria. The latter are subdivided between lower volume (20/year) treatments, accord<strong>in</strong>g to an analysis across North <strong>Wales</strong><br />
undertaken <strong>in</strong> 2009 by Public <strong>Health</strong> <strong>Wales</strong> 1 . Where applicable the specific<br />
circumstances/strict criteria under which use can be considered by the UHB, are set<br />
out together with reference l<strong>in</strong>ks to the available evidence. Procedures will be subject<br />
to the process outl<strong>in</strong>ed <strong>in</strong> Section 3 of this policy. In addition, it will be necessary for<br />
procedures of higher volume to be subject to <strong>in</strong>vestigation and cont<strong>in</strong>uous review to<br />
ensure that the UHB position and <strong>in</strong>terpretation of evidence cont<strong>in</strong>ues to be<br />
4
consistent and appropriate. This will <strong>in</strong>volve appropriate cl<strong>in</strong>ical engagement<br />
processes.<br />
High Cost Drugs<br />
1.14 The priority for the LHB is to provide treatment <strong>in</strong> accordance with NICE<br />
technology appraisals and All <strong>Wales</strong> Medic<strong>in</strong>es Strategy Group (AWMSG) approval<br />
status. It is important to recognise that drugs and procedures not yet reviewed by<br />
either AWMSG or NICE will not normally be provided, nor will drugs or technologies<br />
rejected for use by AWMSG or NICE, except under exceptional circumstances. In<br />
such circumstances, the patient’s cl<strong>in</strong>ician must request fund<strong>in</strong>g prior to commenc<strong>in</strong>g<br />
treatment through the process outl<strong>in</strong>ed <strong>in</strong> this paper. For patients receiv<strong>in</strong>g specific<br />
high cost treatments, these would be covered by the Named Patient Contracts or<br />
Variations as above.<br />
Entitlement of Patients to Treatment Overseas<br />
1.15 This is covered <strong>in</strong> Section 5 of this policy<br />
Section 2 - Legal and Ethical Framework<br />
2.1 The term ‘services’ will be used when referr<strong>in</strong>g to treatment, <strong>in</strong>vestigation,<br />
<strong>in</strong>terventions and other care provided by the NHS. However, many services are not<br />
<strong>in</strong>cluded <strong>in</strong> LTAs and require prior approval. The <strong>Local</strong> <strong>Health</strong> <strong>Board</strong> commissions<br />
the majority of treatment, <strong>in</strong>vestigations, <strong>in</strong>terventions and care through agreed<br />
contracts with other NHS organisations.<br />
2.2 The National <strong>Health</strong> Service is def<strong>in</strong>ed with<strong>in</strong> <strong>in</strong> the National <strong>Health</strong> Service<br />
Acts. This places a duty on the Secretary of State for <strong>Health</strong> (the First M<strong>in</strong>ister <strong>in</strong><br />
<strong>Wales</strong>) to cont<strong>in</strong>ue the promotion of a comprehensive health service designed to<br />
secure health improvement <strong>in</strong> England and <strong>Wales</strong>.<br />
2.3 The <strong>Local</strong> <strong>Health</strong> <strong>Board</strong> make decisions with<strong>in</strong> the parameters of its legal<br />
powers and duties, such as set out <strong>in</strong> the NHS Act 1977 and subsequent NHS<br />
legislation, the Human Rights Act 1998, the Articles of the Human Rights Convention<br />
and <strong>in</strong> accordance with Welsh Assembly Government (WAG) guidance. This legal<br />
framework places duties and obligations upon the LHB to exercise its discretion over<br />
the services that should be provided. Legally the LHB should seek to provide<br />
comprehensive services to the extent that they are considered necessary to meet all<br />
reasonable requirements. These services should be free to users at the po<strong>in</strong>t of<br />
entry (except where there are def<strong>in</strong>ed charges) with<strong>in</strong> a f<strong>in</strong>ite resource and <strong>in</strong><br />
accordance with the fund<strong>in</strong>g which has been made available by the Welsh Assembly<br />
Government.<br />
2.4 <strong>Health</strong> decisions may be subject to legal challenges, which could have<br />
significant f<strong>in</strong>ancial consequences for the LHB. A patient could apply for a judicial<br />
review of an unfavourable decision by the LHB <strong>in</strong> respect of that <strong>in</strong>dividual’s care,<br />
which may be considered on the grounds of illegality, procedural impropriety or<br />
irrationality. These are described below:<br />
5
Legality<br />
Does the LHB have the power to take the action proposed?<br />
Would the proposed decision put the LHB <strong>in</strong> breach of its procedures?<br />
Was the decision taken by the right person or people?<br />
Was there consultation on the decision?<br />
Is there over adherence to a rigid policy or failure to consider the<br />
<strong>in</strong>dividual case aga<strong>in</strong>st the context of the resources available?<br />
Would the decision be <strong>in</strong> breach of the Human Rights Act?<br />
Procedural Propriety<br />
Rationality<br />
Are the procedures used fair to all parties?<br />
Is there a danger that the LHB could breach legitimate expectations<br />
(promises made) of any groups?<br />
Were relevant policies followed?<br />
Has the decision been made <strong>in</strong> an arbitrary manner?<br />
Has the LHB acted <strong>in</strong> a way that no other reasonable LHB would act?<br />
Is the decision sett<strong>in</strong>g any untenable precedents?<br />
Is there sufficient conflict of op<strong>in</strong>ion to justify the op<strong>in</strong>ion be<strong>in</strong>g taken by<br />
a higher authority or through legal processes?<br />
2.5 The decision mak<strong>in</strong>g process is designed to elim<strong>in</strong>ate concerns about<br />
illegality, procedural impropriety or irrationality by mak<strong>in</strong>g the process clear and<br />
transparent.<br />
2.6 This is particularly important:<br />
When other LHBs have made a different decision on a specific topic.<br />
When limit<strong>in</strong>g access to specific services or treatments.<br />
When sett<strong>in</strong>g priorities.<br />
When the evidence is not completely clear and unambiguous.<br />
2.7 The Individual Patient Commission<strong>in</strong>g procedure is founded on a set of core<br />
pr<strong>in</strong>ciples to ensure that a transparent and reasonable ethical process governs the<br />
decision mak<strong>in</strong>g process concern<strong>in</strong>g fund<strong>in</strong>g decisions for the categories of<br />
treatments or services outl<strong>in</strong>ed <strong>in</strong> section 1.<br />
2.8 These pr<strong>in</strong>ciples <strong>in</strong>clude:<br />
i) Benefit versus harm:<br />
Evidence that a treatment or service confers a benefit and is the most<br />
appropriate treatment at this time should be considered<br />
Decisions should be taken on an <strong>in</strong>dividual named patient basis.<br />
6
The default position should be that a treatment outl<strong>in</strong>ed <strong>in</strong> section 1 is not<br />
offered unless all other available and approved options for treatment<br />
under LTAs have previously been explored by the referr<strong>in</strong>g cl<strong>in</strong>ician.<br />
For all applications, sufficient medical history should be made available<br />
and reviewed.<br />
For all applications, evidence of the effectiveness of the treatment or<br />
service should be considered from a variety of sources <strong>in</strong>clud<strong>in</strong>g national<br />
guidance (such as NICE guidance), other sources of cl<strong>in</strong>ical evidence<br />
(such as from the Cochrane Centre) and Public <strong>Health</strong> <strong>Wales</strong> as<br />
appropriate.<br />
For all applications, other options for treatment should have been<br />
considered by the referr<strong>in</strong>g cl<strong>in</strong>ician prior to the request for fund<strong>in</strong>g be<strong>in</strong>g<br />
made.<br />
For all applications, the prognosis of the patient should be considered.<br />
Where the application is made for drug therapy, exist<strong>in</strong>g<br />
recommendations by NICE and/or the All <strong>Wales</strong> Medic<strong>in</strong>es Strategy<br />
Group must be taken <strong>in</strong>to account.<br />
ii) Equity/ Justice: The LHB should aim to provide equal access to treatments<br />
for all their patients, based on need:<br />
The LHB will aim to provide equal access to treatments or services for all<br />
their patients based on need.<br />
The LHB has a statutory duty to achieve f<strong>in</strong>ancial balance and decisions<br />
to limit access to treatments or services legitimately <strong>in</strong>clude aspects<br />
around f<strong>in</strong>ancial costs. Decisions to treat <strong>in</strong>evitably divert resources from<br />
other health care options.<br />
Both cost effectiveness and the <strong>in</strong>dividual cost of treatment should be<br />
considered <strong>in</strong> decid<strong>in</strong>g which treatments or services to limit and <strong>in</strong><br />
reach<strong>in</strong>g decisions on <strong>in</strong>dividual patient needs.<br />
In some cases, the needs of a community for a range of treatments may<br />
outweigh the needs of an <strong>in</strong>dividual for a highly expensive treatment.<br />
Where an alternative, more cost effective solution can be found, it is<br />
appropriate for the LHB to consider this option.<br />
The LHB will consider each case on its <strong>in</strong>dividual merits and will therefore<br />
not set precedents either approv<strong>in</strong>g or refus<strong>in</strong>g a particular treatment or<br />
service for an <strong>in</strong>dividual patient.<br />
iii) Patient choice/autonomy – patients should have a right to request<br />
treatments through their cl<strong>in</strong>ical advocate and have their case heard and<br />
considered<br />
The criteria and process for tak<strong>in</strong>g these decisions should be transparent<br />
and deemed fair.<br />
A separately constituted body to that mak<strong>in</strong>g the <strong>in</strong>itial decisions should<br />
receive and hear any disputes (see Sections 3 and 5 - Appeals Process).<br />
iv) Exceptionality – <strong>in</strong> cases where requests for fund<strong>in</strong>g are made for<br />
7
treatments or services that have not been approved by national guidance<br />
such as NICE, The Cochrane Centre or Public <strong>Health</strong> <strong>Wales</strong> or the All <strong>Wales</strong><br />
Medic<strong>in</strong>es Strategy Group, <strong>in</strong> order for fund<strong>in</strong>g to be agreed then there must<br />
exist an unusual cl<strong>in</strong>ical factor about the patient that suggests that they are<br />
Significantly different to the general population suffer<strong>in</strong>g from their cl<strong>in</strong>ical<br />
condition<br />
Likely to ga<strong>in</strong> significantly more benefit from the treatment or service than<br />
the general patient population with the cl<strong>in</strong>ical condition<br />
The request<strong>in</strong>g cl<strong>in</strong>ician should highlight any case of exceptionality to the<br />
LHB when mak<strong>in</strong>g the fund<strong>in</strong>g application.<br />
The follow<strong>in</strong>g def<strong>in</strong>ition has been recommended for use <strong>in</strong> <strong>Wales</strong> 1 :<br />
Central to consideration of <strong>in</strong>dividual cases is the concept of the case be<strong>in</strong>g<br />
exceptional. The def<strong>in</strong>ition of exception is 'an <strong>in</strong>stance that does not follow a rule'.<br />
There cannot therefore be 'rules' to guide decisions on exceptions; rather such rules<br />
would constitute criteria (policy) to provide the service.<br />
1. In order for fund<strong>in</strong>g to be agreed there must be some unusual* cl<strong>in</strong>ical factor<br />
about the patient that suggests that they are<br />
i. Significantly different to the general population of patients with the<br />
condition <strong>in</strong> question<br />
ii. Likely to ga<strong>in</strong> significantly more benefit from the <strong>in</strong>tervention than<br />
might be expected from the average patient with the condition<br />
2. The fact that a treatment is likely to be efficacious for a patient is not, <strong>in</strong> itself,<br />
a basis for an exemption.<br />
3. If a patient's cl<strong>in</strong>ical condition matches the 'accepted <strong>in</strong>dications' for a<br />
treatment that is not funded, their circumstances are not, by def<strong>in</strong>ition,<br />
exceptional.<br />
4. It is for the request<strong>in</strong>g cl<strong>in</strong>ician (or patient) to make the case for exceptional<br />
status.<br />
5. Social value judgments are rarely relevant to the consideration of exceptional<br />
status<br />
* The <strong>in</strong>itial term<strong>in</strong>ology was ‘unusual or unique’ but it is better to clearly differentiate<br />
unique from exceptional.<br />
1 Adapted from UK Specialized Services Public <strong>Health</strong> Network<br />
8<br />
Comment [R1]: ? add<br />
def<strong>in</strong>ition here
Section 3 - Fund<strong>in</strong>g Application Procedures<br />
3.1 The fund<strong>in</strong>g application process is <strong>in</strong> two stages. The core cl<strong>in</strong>ical structure of<br />
the LHB is based on Cl<strong>in</strong>ical Programme Groups (CPGs) and it is from with<strong>in</strong> these<br />
groups that that the majority of fund<strong>in</strong>g applications will materialise. Recognis<strong>in</strong>g this,<br />
and the place of CPGs <strong>in</strong> be<strong>in</strong>g directly responsible for the delivery of care with<strong>in</strong><br />
their <strong>in</strong>dividual spheres of <strong>in</strong>fluence, applications <strong>in</strong> the first <strong>in</strong>stance should be<br />
considered by the relevant CPG. Only applications considered and supported by the<br />
relevant CPG, and ‘signed off’ by the Chief of Staff, will be considered for fund<strong>in</strong>g by<br />
the LHB IPC Panel.<br />
3.2 Requests for fund<strong>in</strong>g a treatment/service may be made by a GP, hospital<br />
Consultant or other health professional (the referr<strong>in</strong>g cl<strong>in</strong>ician). The LHB will not<br />
normally consider the request for fund<strong>in</strong>g from a GP or a short term locum consultant<br />
(who may not be aware of local services or procedures) direct to a specialist <strong>in</strong> other<br />
NHS organisations with which the LHB does not already hold a contract for that<br />
particular service, unless this has the support of the relevant CPG.<br />
3.3 Self-referrals from patients will not be considered. Requests from patients and<br />
third parties (e.g. elected politicians) will be returned with the advice that the case<br />
should be discussed with the patient’s GP who should forward the request to a local<br />
secondary care consultant or other senior cl<strong>in</strong>ician with a view to discussion at CPG<br />
level. Referrals will not be accepted from a private cl<strong>in</strong>ician unless act<strong>in</strong>g under<br />
contract with the NHS.<br />
3.4 Prior to consider<strong>in</strong>g an application for Individual Patient Commission<strong>in</strong>g<br />
fund<strong>in</strong>g, the CPG will require an NHS Consultant or GP to carry out a full assessment<br />
of the <strong>in</strong>dividual patient’s needs and decide whether the treatment or service be<strong>in</strong>g<br />
requested is the most appropriate for the patient.<br />
3.4.1 Before the request for fund<strong>in</strong>g can be considered by the CPG consideration<br />
will also need to be given to the cl<strong>in</strong>ical governance implications of the treatment – no<br />
fund<strong>in</strong>g request will be approved by the CPG where the cl<strong>in</strong>ical governance<br />
implications have not been addressed.<br />
Where a fund<strong>in</strong>g application is for a given drug evidence of approval from the BCUHB<br />
Drug & Therapeutics Committee (or sub committee at CPG level) will be required<br />
before support for fund<strong>in</strong>g is considered.<br />
3.5 The request for fund<strong>in</strong>g must be made on the agreed request form<br />
(please see Appendix 2) with <strong>in</strong>formation about the follow<strong>in</strong>g completed:<br />
The patient’s medical history<br />
An outl<strong>in</strong>e of the proposed treatment/service <strong>in</strong>clud<strong>in</strong>g an <strong>in</strong>dication of the<br />
likely duration of the treatment<br />
9
Evidence of the cl<strong>in</strong>ical (and where appropriate) cost effectiveness of the<br />
treatment/service (such as from NICE guidance) and other sources of<br />
cl<strong>in</strong>ical evidence (such as from the Cochrane Centre)<br />
Other options for treatment/service that have been considered by the<br />
referr<strong>in</strong>g cl<strong>in</strong>ician and the reasons for exclusion of all alternatives<br />
considered<br />
Relevance to national guidel<strong>in</strong>es (e.g. NICE, Royal Colleges,<br />
Professional bodies) if appropriate<br />
The prognosis of the patient<br />
A statement about why the patient is exceptional, where appropriate (i.e.<br />
where such treatment contradicts current NICE or AWMSG guidance) –<br />
see Section 2 above and Appendix 1.<br />
The full costs of the treatment/service for which fund<strong>in</strong>g approval is be<strong>in</strong>g<br />
sought.<br />
The proposed provider of the treatment/service and where possible,<br />
evidence of the quality of service provided.<br />
Where appropriate, whether HCW has already been approached for<br />
approval.<br />
D&T approval<br />
3.6 Incomplete forms will be returned to the referrer request<strong>in</strong>g additional<br />
<strong>in</strong>formation. It is beholden upon referrers to provide sufficient <strong>in</strong>formation to m<strong>in</strong>imise<br />
this likelihood.<br />
3.7 The requests for fund<strong>in</strong>g will be submitted on the agreed request form to the<br />
Individual Patient Commission<strong>in</strong>g lead officer based with<strong>in</strong> the CPG. Requests will<br />
be received and processed by the nom<strong>in</strong>ated CPG officer who will act as custodians<br />
for the requests.<br />
3.8 The IPC Panel checklist will be completed as part of this process (Appendix 3).<br />
3.9 The nom<strong>in</strong>ated lead officer will <strong>in</strong>itially review the request to confirm that it is<br />
appropriate to be considered by the CPG as follows:<br />
The patient is confirmed to be under the care of the CPG and the request<br />
for treatment rema<strong>in</strong>s with<strong>in</strong> the sphere of responsibility of that CPG.<br />
The patient is resident with<strong>in</strong> the geographical responsibility of the LHB*<br />
All sections of the appropriate request form have been completed<br />
* as def<strong>in</strong>ed by the M<strong>in</strong>isterial letter ref EH/ML/014/09; Border PCTs are<br />
Shropshire County, West Cheshire, Herefordshire and Gloucestershire; From<br />
1st October 2009, the border LHB is def<strong>in</strong>ed as <strong>Betsi</strong> <strong>Cadwaladr</strong> <strong>University</strong><br />
<strong>Local</strong> <strong>Health</strong> <strong>Board</strong> as a whole.<br />
3.10 All requests will be logged on the CPG Individual Patient Commission<strong>in</strong>g<br />
database which will have restricted access and will be ma<strong>in</strong>ta<strong>in</strong>ed with due process<br />
and <strong>in</strong> accordance to strict Caldicott pr<strong>in</strong>ciples.<br />
3.11 Each CPG will be required to form it’s own Panel and/or process that<br />
considers each fund<strong>in</strong>g application <strong>in</strong> terms of cl<strong>in</strong>ical effectiveness and cl<strong>in</strong>ical<br />
10
efficacy; <strong>in</strong> do<strong>in</strong>g so the Chief of Staff of the CPG should ensure that the process is<br />
robust <strong>in</strong> terms of:<br />
• Caldicott pr<strong>in</strong>ciples<br />
• Informed cl<strong>in</strong>ical decision mak<strong>in</strong>g <strong>in</strong> l<strong>in</strong>e with this document<br />
• Cl<strong>in</strong>ical governance and safety<br />
• Consistency<br />
• Transparency<br />
• Timel<strong>in</strong>ess<br />
3.12 The CPG Panel or adopted process should ensure that a decision to support,<br />
or not support, the application is clearly recorded with the rationale beh<strong>in</strong>d the<br />
decision be<strong>in</strong>g clear. The process should ensure communication as to the outcome<br />
with the referr<strong>in</strong>g cl<strong>in</strong>ician at the earliest opportunity.<br />
3.13 The discussion regard<strong>in</strong>g the submissions received by the CPG may <strong>in</strong>clude<br />
the referrer if the CPG deems this appropriate.<br />
3.14 All fund<strong>in</strong>g requests that have been deemed appropriate as above will be<br />
referred to the LHB Independent Commission<strong>in</strong>g Panel for further consideration by<br />
the CPG.<br />
On support<strong>in</strong>g a request the submission will be forwarded to the LHB IPC panel with<br />
a clear <strong>in</strong>dication of that support and the signature of the CPG Chief of Staff<br />
CPG level Appeals<br />
3.15 In the event that the fund<strong>in</strong>g request has not been supported by the CPG, the<br />
referrer will be <strong>in</strong>formed of this outcome as soon as possible. The referrer may wish<br />
to appeal the decision. In the event of an appeal, the referrer will be entitled to submit<br />
the application for fund<strong>in</strong>g to the LHB IPC Panel with clear notification on the<br />
application form that the submission does not have CPG support, with all relevant<br />
application <strong>in</strong>formation upon which the CPG would have considered their decision<br />
and with any comments that would respond to the CPG rejection. This appeal referral<br />
will require agreement from the Chief of Staff before be<strong>in</strong>g progressed. The LHB IPC<br />
Panel would still be entitled to discuss any supplementary <strong>in</strong>formation offered with the<br />
CPG concerned.<br />
The LHB IPC Panel<br />
3.16 It is the <strong>in</strong>tention that BCULHB will have one IPC Panel which would be<br />
comprised of at least THREE <strong>in</strong>dividuals (one of whom must be a cl<strong>in</strong>ician)<br />
constituted by the follow<strong>in</strong>g or their nom<strong>in</strong>ated deputy:<br />
Chief Executive<br />
Executive Medical Director and Director of Cl<strong>in</strong>ical Services<br />
Assistant Medical Director<br />
Executive Director of Nurs<strong>in</strong>g and Patients Services<br />
Executive Director of Primary, Community and Mental <strong>Health</strong> Services<br />
11
Executive Director of Plann<strong>in</strong>g<br />
Executive Director of F<strong>in</strong>ance<br />
Executive Director of Therapies & <strong>Health</strong> Science<br />
IPC Officer<br />
Associate Director of Performance Improvement and Delivery Support<br />
3.17 The f<strong>in</strong>al arrangements for one IPC Panel will be further considered and<br />
detailed <strong>in</strong> the revised IPC Standard Operat<strong>in</strong>g Procedure.<br />
3.18 A panel member must declare an <strong>in</strong>terest if a patient for whom a fund<strong>in</strong>g<br />
request is made is known to the panel member.<br />
3.19 The LHB IPC Panel will only consider fund<strong>in</strong>g requests that have evidence of<br />
CPG support or those unless subject to appeal. The Panel may take advice <strong>in</strong><br />
relation to all requests for treatment from with<strong>in</strong> the relevant CPG, prior to the Panel<br />
mak<strong>in</strong>g a recommendation.<br />
3.20 The LHB Panel may discuss fund<strong>in</strong>g considerations with other LHBs to try and<br />
ensure a consistent approach and the view of any relevant Cl<strong>in</strong>ical Networks may be<br />
sought.<br />
3.21 The LHB Panel will review all the <strong>in</strong>formation supplied on the agreed<br />
request form and will consider how appropriate the request is based on the<br />
<strong>in</strong>formation supplied. The Panel will consider each case on its <strong>in</strong>dividual merit and<br />
will base their recommendation on consideration of the facts presented to them <strong>in</strong> l<strong>in</strong>e<br />
with the agreed core pr<strong>in</strong>ciples outl<strong>in</strong>ed <strong>in</strong> Section 2.<br />
3.22 In reach<strong>in</strong>g its recommendation on each <strong>in</strong>dividual case, the IPC Panel will<br />
consider:<br />
That all previous relevant criteria have been satisfied (see above)<br />
Whether there is a clear evidence base for cl<strong>in</strong>ical outcomes – this will be<br />
established by reference to NICE, Cochrane, Public <strong>Health</strong> <strong>Wales</strong>,<br />
AWMSG, SMC and SIGN and other authoritative sources of evidence; by<br />
ask<strong>in</strong>g relevant professionals with<strong>in</strong> and outside the LHB and by<br />
consult<strong>in</strong>g with Medical Directors of other LHBs or Public <strong>Health</strong> <strong>Wales</strong>.<br />
When an <strong>in</strong>terpretation of evidence is be<strong>in</strong>g made, this should be<br />
validated us<strong>in</strong>g relevant experts such as LHB Medical Directors, or<br />
relevant health professionals with<strong>in</strong> or outside the LHB.<br />
The effect of the proposed treatment or service on the quality of life, the<br />
social and psychological well be<strong>in</strong>g of the patient, symptoms relief and<br />
survival benefit.<br />
Any exceptionality that the <strong>in</strong>dividual patient may exhibit.<br />
3.23 This procedure cannot <strong>in</strong>clude a complete and exhaustive list of all factors to<br />
be considered, as each case will be considered on a case by case basis, and other<br />
case specific criteria may need to be considered on an <strong>in</strong>dividual by <strong>in</strong>dividual basis.<br />
12
3.24 Any recommendation made by the IPC Panel does not reflect a policy or<br />
precedent made by the LHB. Rather it reflects a fund<strong>in</strong>g recommendation made on<br />
an <strong>in</strong>dividual patient after tak<strong>in</strong>g <strong>in</strong>to account cl<strong>in</strong>ical evidence, specific aspects of the<br />
<strong>in</strong>dividual case and any exceptional circumstances.<br />
3.25 Each recommendation made by the IPC Panel will need to be considered by a<br />
BCULHB accredited cl<strong>in</strong>ician to determ<strong>in</strong>e that the recommendation:<br />
• Sets no apparent precedent for future IPC decisions;<br />
• Is congruent and consistent with other IPC decisions.<br />
3.26 Where the recommendation of the IPC Panel is <strong>in</strong>congruent or <strong>in</strong>consistent<br />
with other IPC decisions, the cl<strong>in</strong>ician must be satisfied with the recommendation due<br />
to exceptional circumstances. (see Appendix 3).<br />
3.27 The recommendation of the IPC Panel will need to be ratified by one or more<br />
Executive Director with the <strong>in</strong>tention that the decision will be conveyed by letter to the<br />
referr<strong>in</strong>g cl<strong>in</strong>ician with<strong>in</strong> 5 work<strong>in</strong>g days of the Executive Director(s) reach<strong>in</strong>g their<br />
decision, copied to the relevant Chief of Staff. In extremely urgent cases, the IPC<br />
Lead Officer may telephone the referr<strong>in</strong>g cl<strong>in</strong>ician after the decision has been made<br />
so that treatment may beg<strong>in</strong> without undue delay. The notes of the telephone<br />
conversation should be faxed or e-mailed to the cl<strong>in</strong>ician for confirmation as soon as<br />
possible thereafter; <strong>in</strong>formation should also be shared with the appropriate Chief of<br />
Staff. The cl<strong>in</strong>ician should also be advised to send a copy of the Executive Directors<br />
decision to the patient and this suggestion will be <strong>in</strong>cluded at the end of all IPC<br />
decision letters to the cl<strong>in</strong>ician. The IPC decision letter should <strong>in</strong>clude:<br />
The decision of the Executive Directors<br />
The reasons for the decision<br />
Any conditions imposed on the fund<strong>in</strong>g approval, <strong>in</strong>clud<strong>in</strong>g confirmation<br />
that the approved treatment will be with<strong>in</strong> Welsh National wait<strong>in</strong>g times<br />
standards for referral to treatment, and that the provider organisation will<br />
provide detail of <strong>in</strong>dividual patient wait<strong>in</strong>g times on a monthly basis<br />
Any limits on the fund<strong>in</strong>g approval<br />
Any proposals for future care or discharge arrangements<br />
Any ongo<strong>in</strong>g report<strong>in</strong>g or monitor<strong>in</strong>g <strong>in</strong>formation required as a condition<br />
for the fund<strong>in</strong>g approval – these may need to be confirmed with the<br />
relevant CPG(s)<br />
Any other relevant <strong>in</strong>formation to support the decision taken<br />
Details of the appeals process where fund<strong>in</strong>g request is turned down (see<br />
section 5)<br />
The option to resubmit the request, should any further or additional<br />
relevant <strong>in</strong>formation become available.<br />
3.28 The Executive Medical Director or Executive Director of Plann<strong>in</strong>g (or their<br />
nom<strong>in</strong>ated deputies) must ensure that an overview of the case is ma<strong>in</strong>ta<strong>in</strong>ed <strong>in</strong><br />
collaboration with the referr<strong>in</strong>g cl<strong>in</strong>ician; that reports from the agreed process are<br />
reviewed and acted upon; and, <strong>in</strong> particular, ensure that, at an appropriate time,<br />
satisfactory discharge and aftercare arrangements are <strong>in</strong> place. In cases where there<br />
13
is likely to be a need for <strong>in</strong>termediate, cont<strong>in</strong>u<strong>in</strong>g health care and/or social care on<br />
discharge, a care manager/co-ord<strong>in</strong>ator should be identified at the outset of<br />
treatment/service to ensure cont<strong>in</strong>uity of care.<br />
3.29 The LHB will ma<strong>in</strong>ta<strong>in</strong> a confidential and secure database of all IPC decisions<br />
and the reasons for the decisions.<br />
Submitt<strong>in</strong>g a Fund<strong>in</strong>g Application to the LHB IPC Panel<br />
3.30 Hav<strong>in</strong>g ga<strong>in</strong>ed CPG support the request will be submitted on the completed<br />
form with the added <strong>in</strong>dication of support from the CPG. The request will be<br />
submitted by the designated CPG nom<strong>in</strong>ated lead officer to the Individual Patient<br />
Commission<strong>in</strong>g lead officer based with<strong>in</strong> the LHB. Requests will be received, date<br />
stamped and processed by the nom<strong>in</strong>ated LHB officer who will act as custodians for<br />
the requests. The IPC Panel checklist will be reviewed as part of this process.<br />
3.31 All requests will be logged on the LHB’s Individual Patient Commission<strong>in</strong>g<br />
database which will have restricted access and will be ma<strong>in</strong>ta<strong>in</strong>ed with due process<br />
and <strong>in</strong> accordance to strict Caldicott pr<strong>in</strong>ciples.<br />
3.32 All fund<strong>in</strong>g requests that have been deemed appropriate as above will be<br />
considered by the LHB Independent Commission<strong>in</strong>g Panel that will meet every two<br />
weeks or when necessary.<br />
Section 4 - Child Protection Issues<br />
4.1 This process needs to be read <strong>in</strong> conjunction with the document ‘Best<br />
Practice Guidance for the Monitor<strong>in</strong>g of Packages of Care for Children placed <strong>in</strong> and<br />
outside of <strong>Wales</strong> and funded by the <strong>Local</strong> <strong>Health</strong> <strong>Board</strong>’ (2006) 2 or and All <strong>Wales</strong><br />
Child Protection Procedures (2008). This applies to all children and young people up<br />
to the age of 18 years.<br />
4.2 In addition to the procedures outl<strong>in</strong>ed <strong>in</strong> sections 1-3 above, all requests<br />
made to the LHB for fund<strong>in</strong>g of patients under the age of 18 must consider the<br />
follow<strong>in</strong>g:<br />
If the request is deemed cl<strong>in</strong>ically appropriate, the application will be<br />
approved with the condition that evidence of compliance with the<br />
essential safeguards as outl<strong>in</strong>ed <strong>in</strong> the All <strong>Wales</strong> Child Protection<br />
Procedures is a requirement of fund<strong>in</strong>g.<br />
The Executive Medical Director or Executive Director of Nurs<strong>in</strong>g or<br />
person nom<strong>in</strong>ated by the Directors will request evidence of compliance<br />
with Child Protection and <strong>Health</strong> Status standards as identified <strong>in</strong> the<br />
‘Best Practice Guidance for the Monitor<strong>in</strong>g of Packages of Care for<br />
Children placed <strong>in</strong> and outside of <strong>Wales</strong> and funded by the <strong>Local</strong> <strong>Health</strong><br />
<strong>Board</strong> and All <strong>Wales</strong> Child Protection Procedures.<br />
2 NPHS Best Practice Guidance for the Monitor<strong>in</strong>g of Packages of Care for Children placed <strong>in</strong> and<br />
outside of <strong>Wales</strong> and funded by the <strong>Local</strong> <strong>Health</strong> <strong>Board</strong>’ (2006)<br />
14<br />
Comment [R2]: Has this been<br />
run through All <strong>Wales</strong> Child<br />
Protection Service?
A copy of the best practice guidance document and the l<strong>in</strong>k to the Child<br />
Protection Procedures will be forwarded to the proposed placement/<br />
current placement with a cover<strong>in</strong>g letter.<br />
Evidence provided should be recorded and further evidence of<br />
compliance requested if needed.<br />
Update <strong>in</strong>formation on placements used on a regular basis by the LHB<br />
should be requested and updated annually.<br />
Section 5 - Entitlement of Patients to Treatments Overseas<br />
5.1 Under current arrangements, patients are entitled to seek NHS fund<strong>in</strong>g for<br />
treatment overseas, whether via the E112 procedure or the Article 49 route. Refer to<br />
WHC 2007 044 for full details. Residents of North <strong>Wales</strong> are lawfully required to ga<strong>in</strong><br />
prior authorisation from the UHB to ensure that there is sufficient and permanent and<br />
access to high-quality hospital treatment, to control costs and prevent wastage of<br />
f<strong>in</strong>ancial, technical and human resources.<br />
5.2 Requests for overseas treatments will follow the process outl<strong>in</strong>ed <strong>in</strong> Section 3 of<br />
this policy and needs to be referred to the IPC panel us<strong>in</strong>g the appropriate form. The<br />
follow<strong>in</strong>g additional <strong>in</strong>formation is required:<br />
• How treatment centre was identified<br />
• Op<strong>in</strong>ion on reasonable wait<strong>in</strong>g time for patient based on their cl<strong>in</strong>ical<br />
f<strong>in</strong>d<strong>in</strong>gs<br />
• Why the patient cannot be offered treatment with<strong>in</strong> this wait<strong>in</strong>g time at the<br />
local service<br />
• Aftercare needs<br />
• Contribution to aftercare arrangements<br />
5.3 The criteria for UHB support are:<br />
• an objective cl<strong>in</strong>ical assessment of the patient’s cl<strong>in</strong>ical needs as set out <strong>in</strong><br />
form HCDP 01 and considered by the IPC Panel;<br />
• where a wait<strong>in</strong>g list exists, that the wait<strong>in</strong>g time for treatment with<strong>in</strong> the<br />
local service exceeds the time that it is cl<strong>in</strong>ically acceptable for the patient<br />
to wait at the time of the request on the basis of the cl<strong>in</strong>ical assessment;<br />
and<br />
• there is no other NHS provider who can offer treatment to the patient with<strong>in</strong><br />
the time deemed appropriate based on the cl<strong>in</strong>ical assessment.<br />
All 3 criteria must be met <strong>in</strong> order for an overseas treatment/procedure to be<br />
agreed.<br />
5.4 The UHB will only consider fund<strong>in</strong>g for treatment for the patient. Fund<strong>in</strong>g for<br />
carers travell<strong>in</strong>g with the patient will not be considered.<br />
15
5.5 The UHB will make contact with the suggested treatment centre <strong>in</strong> Europe to<br />
confirm;<br />
• The estimated cost of treatment<br />
• That the Cl<strong>in</strong>ician is will<strong>in</strong>g to treat the patient<br />
• That the hospital supports the E112 system<br />
• Timescale for delivery of treatment<br />
• Aftercare arrangements.<br />
5.6 Should the request for fund<strong>in</strong>g be granted by the UHB, the referral to Europe<br />
will be made through the E112 process. The Department of <strong>Health</strong> is<br />
responsible for co-ord<strong>in</strong>at<strong>in</strong>g the <strong>in</strong>formation and arrang<strong>in</strong>g for the issue of the<br />
E112. In order to approve E112 applications, the Department of <strong>Health</strong><br />
requires the follow<strong>in</strong>g <strong>in</strong>formation:<br />
• Referral from a Consultant <strong>in</strong> the UK to a Cl<strong>in</strong>ician <strong>in</strong> Europe;<br />
• Letter of support from General Practitioner;<br />
• Written support of <strong>Local</strong> <strong>Health</strong> <strong>Board</strong> confirm<strong>in</strong>g that they will underwrite<br />
the cost of treatment;<br />
• Treatment commencement date and approximate duration of the treatment<br />
(E112 can only be issued for up to six months per episode of treatment)<br />
• Written confirmation of aftercare arrangements.<br />
5.7 The payment for treatment is processed through the Benefits Office <strong>in</strong><br />
Newcastle. <strong>Local</strong> <strong>Health</strong> <strong>Board</strong>s underwrite the costs and they are deducted<br />
from any future allocations.<br />
Section 6 – LHB level Appeals Process<br />
6.1 The role of the appeals process is to ensure that due process was employed<br />
by the orig<strong>in</strong>al Independent Patient Commission<strong>in</strong>g Panel and that the<br />
recommendation of that Panel and the decision of the Executive Director(s) <strong>in</strong>volved<br />
were was reasonable based on the <strong>in</strong>formation available.<br />
6.2 Should the referr<strong>in</strong>g cl<strong>in</strong>ician or patient be unhappy with the decision taken by<br />
the LHB, they have the right to challenge the decision with<strong>in</strong> 28 days of the letter<br />
be<strong>in</strong>g received by the cl<strong>in</strong>ician. Should a third party, other than the referrer, wish to<br />
appeal aga<strong>in</strong>st the decision, written confirmation and authority must be obta<strong>in</strong>ed from<br />
the patient confirm<strong>in</strong>g that the third party is act<strong>in</strong>g on the patient’s behalf.<br />
6.3 The referr<strong>in</strong>g cl<strong>in</strong>ician or patient/third party representative should write to the<br />
Chief Executive or Executive Medical Director, clearly detail<strong>in</strong>g the reason/s for their<br />
dissatisfaction. Any such appeal should receive the support of the relevant CPG,<br />
through the Chief of Staff and evidence regard<strong>in</strong>g this, be clear <strong>in</strong> any<br />
correspondence (there is not a requirement for the CPG Panel to be re-convened).<br />
The Chief of Staff should be <strong>in</strong> agreement with the appeal be<strong>in</strong>g made.<br />
16
6.4 On receipt of this correspondence, the Chief Executive or Executive Medical<br />
Director will then identify an appropriate alternative Director (not one <strong>in</strong>volved <strong>in</strong> the<br />
orig<strong>in</strong>al Panel decision) to act as an Investigat<strong>in</strong>g Officer and review the case to<br />
ensure that the LHB process has been fully implemented and followed. Should all<br />
LHB Directors have been <strong>in</strong>volved <strong>in</strong> the orig<strong>in</strong>al Panel decision the Chief Executive<br />
will identify an <strong>in</strong>dependent officer to review the case from outside the LHB.<br />
6.5 The Investigat<strong>in</strong>g Officer will convene an IPC Appeals Panel to consider the<br />
orig<strong>in</strong>al decision based on the evidence available to it. It will consider :<br />
Was the orig<strong>in</strong>al IPC Panel recommendation and Executive Director<br />
decision made <strong>in</strong> accordance with LHB procedures?<br />
Was due process followed?<br />
Was the decision legal?<br />
Was the decision made with consideration of all relevant factors<br />
available at the time?<br />
Was the decision reasonable and rational?<br />
Did the decision take due regard of the LHB’s legal and ethical<br />
framework?<br />
<br />
(See Section 2 for further details).<br />
6.6 The Investigat<strong>in</strong>g Officer will convene the IPC Appeals Panel as soon as is<br />
practical, especially for those cases where an early commencement of treatment<br />
would be needed. The membership of the group would be dictated by availability of<br />
appropriate LHB personnel but ideally should conta<strong>in</strong>:<br />
The Investigat<strong>in</strong>g Officer (chair)<br />
Other LHB Director<br />
An external or non <strong>in</strong>volved senior medical cl<strong>in</strong>ician Senior<br />
Senior plann<strong>in</strong>g representation<br />
Non-Executive <strong>Board</strong> member (lay representation)<br />
6.7 The members of the IPC Review Appeals must not have been <strong>in</strong>volved <strong>in</strong> the<br />
orig<strong>in</strong>al IPC Panel, and <strong>in</strong> order to ensure an adequate level of expertise, may well<br />
<strong>in</strong>volve members from other LHBs. The Investigat<strong>in</strong>g Officer may well seek advice<br />
from appropriate sources and request the attendance of such <strong>in</strong>dividuals at the<br />
review Panel. The attendance of orig<strong>in</strong>al IPC Panel members or Executive Directors<br />
might also be appropriate.<br />
6.8 The IPC Appeals Panel should not be asked to look at any new evidence that<br />
might have been submitted s<strong>in</strong>ce the decision follow<strong>in</strong>g the orig<strong>in</strong>al IPC Panel.<br />
Should new evidence be available, the Appeals Panel may request the IPC Panel to<br />
reconsider their orig<strong>in</strong>al recommendation <strong>in</strong> the light of the new evidence (see section<br />
3.20)<br />
6.9 The review of the case must be completed with<strong>in</strong> 28 days of the receipt by the<br />
LHB of the request for review of the case. Should it be anticipated that the review will<br />
17
equire longer than 28 days, the LHB must <strong>in</strong>form the referr<strong>in</strong>g cl<strong>in</strong>ician/patient of an<br />
<strong>in</strong>dication of the amount of time that will be required to complete the review.<br />
6.10 After due consideration, the IPC Review Panel may:<br />
Agree with and uphold the orig<strong>in</strong>al decision<br />
Disagree with the orig<strong>in</strong>al decision and request the <strong>Board</strong> Directors or<br />
IPC Panel to reconsider<br />
Partly agree with the orig<strong>in</strong>al decision and make its own<br />
recommendations to the IPC Panel and Executive Directors<br />
5.11 Should the referr<strong>in</strong>g cl<strong>in</strong>ician/patient/third party representative rema<strong>in</strong><br />
dissatisfied follow<strong>in</strong>g the review of their case, they will then be directed to the LHB<br />
compla<strong>in</strong>ts procedure. Such an approach should normally occur with<strong>in</strong> 28 days of<br />
receipt of the appeals decision.<br />
Section 7 – Audit, Monitor<strong>in</strong>g and Review Arrangements<br />
7.1 The <strong>Betsi</strong> <strong>Cadwaladr</strong> <strong>University</strong> <strong>Local</strong> <strong>Health</strong> <strong>Board</strong> will monitor compliance<br />
with the procedure on an ongo<strong>in</strong>g basis by:<br />
Ma<strong>in</strong>ta<strong>in</strong><strong>in</strong>g a confidential database of all IPC Panel activity (see<br />
sections 3.7, 3.9, 3.10 3.24 and 3.25) and regularly review this activity<br />
Monitor<strong>in</strong>g of all costs <strong>in</strong>curred through the IPC procedure<br />
7.2 Provid<strong>in</strong>g a summary report to the LHB and CPG <strong>Board</strong>s on a six monthly basis<br />
18
Section 8 – Communications Strategy<br />
8.1 In order to ensure agreement and compliance with the IPC procedure, the LHB<br />
will dissem<strong>in</strong>ate the procedure to all local stakeholders – particularly local GPs,<br />
CPGs, Hospital Consultants and other Senior Cl<strong>in</strong>icians. Copies of the procedure<br />
may also be sent to local Members of Parliament and National Assembly for <strong>Wales</strong><br />
members if and when they seek to make an appeal on behalf of their constituents<br />
(see paragraph 3.3).<br />
19
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IPC Process – Algorithm<br />
Submission submitted<br />
by CPG but with clear<br />
<strong>in</strong>dication that CPG<br />
does not support<br />
Not supported<br />
Cl<strong>in</strong>ician decides<br />
to<br />
appeal<br />
Consultant or GP or<br />
healthcare<br />
professional submits<br />
IPC fund<strong>in</strong>g request<br />
CPG IPC<br />
Panel<br />
Not Supported Supported<br />
LHB IPC Panel<br />
Appeals LHB IPC Panel<br />
Supported<br />
Fund<strong>in</strong>g identified<br />
20<br />
C<br />
o<br />
m<br />
m<br />
u<br />
n<br />
i<br />
c<br />
a<br />
t<br />
i<br />
o<br />
n
APPENDIX 1<br />
LOW EFFECTIVENESS PROCEDURES (LEPs)<br />
1. Introduction<br />
An evidence based approach uses the current best evidence <strong>in</strong> the decision mak<strong>in</strong>g<br />
process, to ensure cl<strong>in</strong>ical effectiveness and maximum health ga<strong>in</strong> from the<br />
resources available. The document provides a recommended list of treatments,<br />
procedures and therapies that should not be available or have limited availability<br />
across North <strong>Wales</strong>. The recommended course of action is provided, along with the<br />
current advice to support the recommendation. OPCS codes are also provided. For<br />
each procedure listed, Public <strong>Health</strong> <strong>Wales</strong> had provided the evidence upon which<br />
the LHB has based its decisions on whether to use or not. Pharmaceutical treatments<br />
are excluded, as there is a separate process for look<strong>in</strong>g at these. The list is based on<br />
a rapid review of exist<strong>in</strong>g guidance from NICE and Public <strong>Health</strong> <strong>Wales</strong>, as well as a<br />
review of exist<strong>in</strong>g UK-wide policies.<br />
Procedures are split between those that should not be used <strong>in</strong> any circumstance and<br />
those that should not be used except under strict criteria. The latter are subdivided<br />
between lower volume (20/year) treatments,<br />
accord<strong>in</strong>g to an analysis across North <strong>Wales</strong> undertaken <strong>in</strong> 2009 by Public <strong>Health</strong><br />
<strong>Wales</strong> 1 . Where applicable the specific circumstances/strict criteria under which use<br />
can be considered by the LHB, are set out together with reference l<strong>in</strong>ks to the<br />
available evidence. Procedures will be subject to the process outl<strong>in</strong>ed <strong>in</strong> Section 3 of<br />
the ma<strong>in</strong> policy. In addition, it will be necessary for procedures of higher volume to be<br />
subject to <strong>in</strong>vestigation and cont<strong>in</strong>uous review to ensure that the LHB position and<br />
<strong>in</strong>terpretation of evidence cont<strong>in</strong>ues to be consistent and appropriate. This will<br />
<strong>in</strong>volve appropriate cl<strong>in</strong>ical engagement processes. NB. Procedures that are normally<br />
funded by <strong>Health</strong> Commission <strong>Wales</strong> and its successor organisation the Welsh<br />
<strong>Health</strong> Specialised Services Committee (WHSSC) have been shaded <strong>in</strong> grey.<br />
This does not purport to be a def<strong>in</strong>itive list of LEPs. For example, NICE has published<br />
a list of Interventional Procedure Guidance available via the follow<strong>in</strong>g webl<strong>in</strong>k:<br />
http://www.nice.org.uk/Guidance/IP/Published, which should be consulted. It has also<br />
helped health professionals identify what additional measures should be put <strong>in</strong> place<br />
when implement<strong>in</strong>g this guidance by add<strong>in</strong>g an ‘arrangements’ column as follows:<br />
Type of Description<br />
arrangement<br />
Normal Apply normal consent, audit and cl<strong>in</strong>ical governance arrangements plus any<br />
additional recommendations, for example, on tra<strong>in</strong><strong>in</strong>g, service delivery or data<br />
collection.<br />
Special Notify cl<strong>in</strong>ical governance leads, ensure patients understand the uncerta<strong>in</strong>ties<br />
referred to <strong>in</strong> the guidance, and audit and review cl<strong>in</strong>ical outcomes of all patients<br />
hav<strong>in</strong>g the procedure plus any additional recommendations, for example, on tra<strong>in</strong><strong>in</strong>g,<br />
service delivery or data collection.<br />
Other(see Guidance recommends a comb<strong>in</strong>ation of normal or special arrangements.<br />
guidance)<br />
Research only Use only <strong>in</strong> the context of a formal research protocol.<br />
Do not use The procedure should not be used <strong>in</strong> the National <strong>Health</strong> Service.<br />
21
2. Procedures which should NOT be used by the NHS <strong>in</strong> any circumstance<br />
OPCS Condition Criteria Source of advice Remarks<br />
C40.4<br />
C44.1<br />
C44.2<br />
C46.1<br />
C46.7<br />
C47.6<br />
S33.1<br />
S33.2<br />
S33.3<br />
S33.8<br />
S33.9<br />
L78.8<br />
Y08.9<br />
OR<br />
L79.8<br />
Y08.9<br />
K23.4<br />
Y53.-<br />
Corneal implants<br />
for the correction<br />
of refractive<br />
error <strong>in</strong> the<br />
absence of other<br />
ocular pathology<br />
such as<br />
keratoconus.<br />
Correction of<br />
male pattern<br />
baldness<br />
Facial Atrophy –<br />
New-Fill<br />
Procedures<br />
Laparoscopic<br />
uter<strong>in</strong>e nerve<br />
ablation (LUNA)<br />
for chronic pelvic<br />
pa<strong>in</strong><br />
Percutaneous<br />
laser<br />
revascularisation<br />
N/A NICE Interventional Procedure Guidance<br />
225 2<br />
http://guidance.nice.org.uk/IPG225/guidan<br />
ce/pdf/English<br />
N/A <strong>Health</strong> Commission <strong>Wales</strong>.<br />
Commission<strong>in</strong>g Criteria – Plastic Surgery.<br />
Procedures of Low Cl<strong>in</strong>ical Priority/<br />
Procedures not usually available on the<br />
National <strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/publications/healt<br />
hcommission/policies/plasticsurgery/plasti<br />
csurgerye.pdf<br />
N/A <strong>Health</strong> Commission <strong>Wales</strong>.<br />
Commission<strong>in</strong>g Criteria – Plastic Surgery.<br />
Procedures of Low Cl<strong>in</strong>ical Priority/<br />
Procedures not usually available on the<br />
National <strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/publications/healt<br />
hcommission/policies/plasticsurgery/plasti<br />
csurgerye.pdf<br />
N/A NICE Interventional Procedure Guidance<br />
234<br />
http://guidance.nice.org.uk/IPG234<br />
N/A NICE Interventional Procedure Guidance<br />
302<br />
http://www.nice.org.uk/nicemedia/pdf/IPG3<br />
Current evidence on the efficacy of corneal implants for<br />
the correction of refractive error shows limited and<br />
unpredictable benefit. In addition, there are concerns<br />
about the safety of the procedure for patients with<br />
refractive error which can be corrected by other means,<br />
such as spectacles, contact lenses, or laser refractive<br />
surgery.<br />
“Male pattern” baldness is a normal process for many<br />
men at whatever age it occurs.<br />
Facial atrophy is a loss of fat from the sk<strong>in</strong>. Gel polymers<br />
such as New-Fill can be <strong>in</strong>jected under the sk<strong>in</strong> to recontour<br />
the depleted areas.<br />
The evidence on laparoscopic uter<strong>in</strong>e nerve ablation<br />
(LUNA) for chronic pelvic pa<strong>in</strong> suggests that it is not<br />
efficacious and therefore should not be used.<br />
Current evidence on percutaneous laser<br />
revascularisation (PLR) for refractory ang<strong>in</strong>a pectoris<br />
shows no efficacy and suggests that the procedure may
OPCS Condition Criteria Source of advice Remarks<br />
Y08.- for refractory<br />
ang<strong>in</strong>a pectoris<br />
C55.4 Scleral<br />
expansion<br />
surgery for<br />
presbyopia<br />
F32.8 Soft-palate<br />
implants for<br />
obstructive sleep<br />
apnoea<br />
Y53.2 Therapeutic use<br />
of ultrasound <strong>in</strong><br />
hip and knee<br />
osteoarthritis<br />
K23.4<br />
Y08.-<br />
Transmyocardial<br />
laser<br />
revascularisation<br />
for refractory<br />
ang<strong>in</strong>a pectoris<br />
02Guidance.pdf pose unacceptable safety risks.<br />
N/A NICE Interventional Procedure Guidance<br />
70<br />
http://guidance.nice.org.uk/IPG70<br />
N/A NICE Interventional Procedure Guidance<br />
241<br />
http://www.nice.org.uk/nicemedia/pdf/IPG2<br />
41Guidance.pdf<br />
N/A Public <strong>Health</strong> <strong>Wales</strong> Evidence-Based<br />
Information<br />
http://www2.nphs.wales.nhs.uk:8080/healt<br />
hserviceqdtdocs.nsf/PublicPage?OpenPag<br />
e<br />
N/A NICE Interventional Procedure Guidance<br />
301<br />
http://www.nice.org.uk/nicemedia/pdf/IPG3<br />
01FullGuidance.pdf<br />
Current evidence on the safety and efficacy of scleral<br />
expansion surgery for presbyopia is very limited. There<br />
is no evidence of efficacy <strong>in</strong> the majority of patients.<br />
There are also concerns about the potential risks of the<br />
procedure.<br />
Current evidence on soft-palate implants for obstructive<br />
sleep apnoea (OSA) raises no major safety concerns,<br />
but there is <strong>in</strong>adequate evidence that the procedure is<br />
efficacious <strong>in</strong> the treatment of this potentially serious<br />
condition for which other treatments exist.<br />
The evidence suggests that the therapeutic use of<br />
ultrasound <strong>in</strong> hip and knee osteoarthritis provides no<br />
benefits beyond placebo, ultrasound or other<br />
electrotherapy agents <strong>in</strong> the treatment of hip and knee<br />
osteoarthritis.<br />
Current evidence on transmyocardial laser<br />
revascularisation (TMLR) for refractory ang<strong>in</strong>a pectoris<br />
shows no efficacy, based on objective measurements of<br />
myocardial function and survival. Current evidence on<br />
safety suggests that the procedure may pose<br />
unacceptable risks.<br />
23
3. LOWER VOLUME procedures which should NOT be used by the NHS EXCEPT under strict criteria<br />
OPCS Condition Criteria Source of Advice Remarks<br />
W71.4<br />
W85.3<br />
G28.4<br />
G30.1<br />
G30.2<br />
G30.2<br />
G30.4<br />
G30.8<br />
G30.9<br />
G71.6<br />
X85.1<br />
Autologus Chrondrocyte<br />
implantation for knee/ ankle<br />
problems caused by damaged<br />
articular cartilage<br />
Bariatric Surgery for morbid<br />
obesity<br />
Botul<strong>in</strong>um Tox<strong>in</strong><br />
Should NOT be used EXCEPT <strong>in</strong><br />
research studies that are designed to<br />
produce good quality <strong>in</strong>formation about<br />
the results of this procedure.<br />
See HCW policy for criteria<br />
Should NOT be used EXCEPT for the<br />
treatment of pathological conditions by<br />
appropriate specialists <strong>in</strong> cases of:<br />
• Frey’s syndrome.<br />
• Blepharospasm.<br />
• Cerebral Palsy.<br />
• Hyperhidrosis.<br />
NICE Technology<br />
Appraisal 89<br />
http://www.nice.org.uk/pa<br />
ge.aspx?o=TA089<br />
Public <strong>Health</strong> <strong>Wales</strong><br />
Evidence-Based<br />
Information<br />
http://www2.nphs.wales.n<br />
hs.uk:8080/healthservice<br />
qdtdocs.nsf/PublicPage?<br />
OpenPage<br />
HCW policy is currently<br />
be<strong>in</strong>g revised and will be<br />
issued shortly<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
Evidence suggests that ACI has most<br />
commonly been used as a treatment for<br />
cartilage defects <strong>in</strong> the knee. There are<br />
few studies of its use <strong>in</strong> other jo<strong>in</strong>ts. There<br />
are uncerta<strong>in</strong>ties about the potential<br />
adverse effects of the procedure and<br />
long-term effectiveness.<br />
Botul<strong>in</strong>um tox<strong>in</strong> is not available for the<br />
treatment of facial age<strong>in</strong>g or excessive<br />
wr<strong>in</strong>kles.
OPCS Condition Criteria Source of Advice Remarks<br />
S02.1<br />
S02.2<br />
S02.8<br />
S02.9<br />
S03.1<br />
S03.2<br />
S03.3<br />
S03.8<br />
S03.9<br />
Body Contour<strong>in</strong>g - ‘Tummy<br />
Tuck’ (Apronectomy or<br />
Abdom<strong>in</strong>oplasty)<br />
Body Contour<strong>in</strong>g – Other e.g.<br />
Buttock lift, Thigh lift, Arm lift<br />
(brachioplasty)<br />
Should NOT be used EXCEPT for the<br />
follow<strong>in</strong>g groups of patients who should<br />
have achieved a stable BMI between 18<br />
and 25Kg/m2 and be suffer<strong>in</strong>g from<br />
severe functional problems:<br />
• Those with scarr<strong>in</strong>g follow<strong>in</strong>g trauma<br />
or previous abdom<strong>in</strong>al surgery.<br />
• Those who are undergo<strong>in</strong>g treatment<br />
for morbid obesity and have excessive<br />
abdom<strong>in</strong>al sk<strong>in</strong> folds.<br />
• Previously obese patients who have<br />
achieved significant weight loss and<br />
have ma<strong>in</strong>ta<strong>in</strong>ed their weight loss for<br />
at least two years.<br />
• Where it is required as part of<br />
abdom<strong>in</strong>al hernia correction or other<br />
abdom<strong>in</strong>al wall surgery.<br />
Should NOT be USED except <strong>in</strong><br />
exceptional circumstances.<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
Ma<strong>in</strong>tenance of a stable weight is<br />
important so that the risks of recurrent<br />
obesity are reduced.<br />
If there is severe and disabl<strong>in</strong>g<br />
psychological distress as a result of<br />
abdom<strong>in</strong>al wall scarr<strong>in</strong>g, psychological<br />
therapy should be the <strong>in</strong>itial treatment.<br />
Severe functional problems <strong>in</strong>clude:<br />
• Recurrent <strong>in</strong>tertrigo beneath the sk<strong>in</strong><br />
fold.<br />
• Experienc<strong>in</strong>g severe difficulties with<br />
daily liv<strong>in</strong>g i.e. ambulatory restrictions.<br />
• Where previous trauma or surgical<br />
scarr<strong>in</strong>g (usually midl<strong>in</strong>e vertical, or<br />
multiple) leads to very poor appearance<br />
and results <strong>in</strong> disabl<strong>in</strong>g psychological<br />
distress or risk of <strong>in</strong>fection.<br />
• Problems associated with poorly fitt<strong>in</strong>g<br />
stoma bags.<br />
The functional disturbance of sk<strong>in</strong> excess<br />
<strong>in</strong> these sites tends to be less than that <strong>in</strong><br />
excessive abdom<strong>in</strong>al sk<strong>in</strong> folds and so<br />
surgery is less likely to be <strong>in</strong>dicated<br />
except for appearance.<br />
25
OPCS Condition Criteria Source of Advice Remarks<br />
B31.1<br />
B27.5<br />
B31.2<br />
B30.1<br />
Breast - Male Reduction for<br />
Gynaecomastia<br />
Breast - Enlargement<br />
(Augmentation Mammoplasty)<br />
Should NOT be used EXCEPT if the<br />
patient is post pubertal and of normal<br />
BMI i.e. 18 - 25Kg/m2.<br />
Should NOT be used EXCEPT for<br />
women with an absence of breast tissue<br />
unilaterally or bilaterally, or <strong>in</strong> women<br />
with a significant degree of asymmetry of<br />
breast shape and / or volume (one cup<br />
size difference). Such situations may<br />
arise as a result of:<br />
• Previous mastectomy or excisional<br />
breast surgery.<br />
• Trauma to the breast dur<strong>in</strong>g or after<br />
development.<br />
• Congenital amastia (total failure of<br />
breast development).<br />
• Endocr<strong>in</strong>e abnormalities.<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
There should be a pathway established to<br />
ensure that appropriate screen<strong>in</strong>g for<br />
endocr<strong>in</strong>ological and drug related causes<br />
and to exclude testicular cancer through<br />
exam<strong>in</strong>ation <strong>in</strong> Primary Care prior to<br />
consultation with a Plastic Surgeon.<br />
Liposuction may form part of the<br />
treatment plan for this condition.<br />
Patients who are offered breast<br />
augmentation <strong>in</strong> the NHS should be<br />
encouraged to participate <strong>in</strong> the U.K.<br />
national breast implant registration<br />
system and be fully counselled regard<strong>in</strong>g<br />
the risks and natural history of breast<br />
implants. Patients should be provided with<br />
a copy of the DoH guidance booklet<br />
“Breast implants <strong>in</strong>formation for women<br />
consider<strong>in</strong>g breast implants”. (See<br />
website: www.doh.uk/bimplants). It is<br />
important that patients understand that<br />
they may not automatically be entitled to<br />
replacement of the implants <strong>in</strong> the future if<br />
26
OPCS Condition Criteria Source of Advice Remarks<br />
B31.4<br />
B30.2<br />
B30.3<br />
B30.4<br />
Breast- Revision of<br />
Mammoplasty<br />
B35.6 Breast- Correction of Nipple<br />
Inversion<br />
• Developmental asymmetry.<br />
Patients must have a BMI with<strong>in</strong> the<br />
range of 18Kg/m2 to 25 Kg/m2.<br />
Should NOT be used EXCEPT if the<br />
NHS funded the orig<strong>in</strong>al surgery.<br />
.<br />
Should NOT be used EXCEPT for<br />
functional reasons <strong>in</strong> a post-pubertal<br />
woman and if the <strong>in</strong>version has not been<br />
corrected by correct use of a non<strong>in</strong>vasive<br />
suction device.<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
they do not meet the criteria for<br />
augmentation at that time.<br />
If revisional surgery is be<strong>in</strong>g carried out<br />
for implant failure, the decision to replace<br />
the implant(s) rather than simply remove<br />
them should be based upon the cl<strong>in</strong>ical<br />
need for replacement and whether the<br />
patient meets the criteria for<br />
augmentation at the time of revision<br />
Exclude malignancy as a cause - any<br />
recent nipple <strong>in</strong>version might be<br />
suggestive of breast cancer and will<br />
require referral to the breast service under<br />
the rapid access two-week rule<br />
B31.3 Should NOT be used EXCEPT <strong>in</strong> severe <strong>Health</strong> Commission This is <strong>in</strong>cluded as part of the treatment of<br />
27
OPCS Condition Criteria Source of Advice Remarks<br />
Breast – Breast Lift<br />
(Mastopexy)<br />
G80.2 Capsule Endoscopy/ Pillcam<br />
A70.6<br />
X61.1<br />
X61.1<br />
X61.2<br />
X61.3<br />
X61.4<br />
X61.8<br />
X61.9<br />
Complementary Therapies<br />
and Alternative Medic<strong>in</strong>e e.g.<br />
Acupuncture<br />
Alexander technique<br />
Aromatherapy<br />
Herbal medic<strong>in</strong>e<br />
Hypnosis<br />
Homeopathy<br />
Massage<br />
Nutritional therapy<br />
Reflexology<br />
Other alternative therapies<br />
cases (Regnault Grade III) where the<br />
nipple lies below the <strong>in</strong>fra-mammary fold<br />
and below the most project<strong>in</strong>g portion of<br />
the breast <strong>in</strong> the erect position.<br />
Should NOT be used EXCEPT for<br />
disease of the small bowel for:<br />
• Overt or transfusion dependant<br />
bleed<strong>in</strong>g from GI tract, when source<br />
not identified on OGD/Colonoscopy<br />
• Crohns Disease <strong>in</strong> whom strictures are<br />
not suspected<br />
• Hereditary GI polyposis syndromes<br />
Complementary medic<strong>in</strong>e/ alternative<br />
therapies are generally NOT used by the<br />
NHS. They are occasionally used as a<br />
treatment as part of a ma<strong>in</strong>stream<br />
service care plan (e.g. as part of an<br />
<strong>in</strong>tegrated multidiscipl<strong>in</strong>ary approach to<br />
symptom control by a hospital based<br />
pa<strong>in</strong> management team) and as such will<br />
be used as part of an exist<strong>in</strong>g contract.<br />
On exist<strong>in</strong>g available evidence the LHB<br />
will not support referral outside of the<br />
NHS for these services. Prior approval is<br />
required on a case by case basis for any<br />
requests outside the above criteria. The<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
NICE Interventional<br />
Procedure Guidance 101<br />
http://guidance.nice.org.u<br />
k/IPG101<br />
Public <strong>Health</strong> <strong>Wales</strong><br />
Evidence-Based<br />
Information<br />
http://www2.nphs.wales.n<br />
hs.uk:8080/healthservice<br />
qdtdocs.nsf/PublicPage?<br />
OpenPage<br />
breast asymmetry and reduction (see<br />
previous) but not for purely<br />
cosmetic/aesthetic purposes such as<br />
post-lactation ptosis.<br />
The evidence suggests that there are<br />
large numbers of complementary and<br />
alternative therapies that have not been<br />
subject to the trials used to establish the<br />
effectiveness of conventional cl<strong>in</strong>ical<br />
treatments. The evidence base is<br />
develop<strong>in</strong>g and up to date evidence on<br />
complementary therapies and alternative<br />
treatments can be obta<strong>in</strong>ed from the<br />
Cochrane library and specialist evidence<br />
of NHS Library.<br />
28
OPCS Condition Criteria Source of Advice Remarks<br />
N30.3<br />
F11.5<br />
F11.6<br />
Circumcision<br />
request for referral would need to be<br />
supported by evidence of the cl<strong>in</strong>ical<br />
effectiveness of the treatment and be to<br />
appropriately tra<strong>in</strong>ed and qualified<br />
practitioners with recognised<br />
qualifications.<br />
Should NOT be used EXCEPT <strong>in</strong> the<br />
follow<strong>in</strong>g cases:<br />
• Phimosis<br />
• Paraphmosis<br />
• Balantis and Balanoposthitis<br />
• Penile Cancer affect<strong>in</strong>g the foresk<strong>in</strong><br />
Dental implants Should NOT be used EXCEPT for<br />
patients who need post cancer<br />
reconstruction, major trauma with bone<br />
loss, anodontia, or on the advice of NHS<br />
specialists.<br />
The Faculty of Dental Surgery has<br />
produced guidance on the selection of<br />
patients for dental implant treatment<br />
with<strong>in</strong> the NHS. These <strong>in</strong>clude three<br />
groups of patients for consideration:<br />
1. Endentulous <strong>in</strong> one or both jaws:<br />
• Severe denture <strong>in</strong>tolerance (e.g.<br />
gagg<strong>in</strong>g, pa<strong>in</strong>)<br />
• Prevention of severe alveolar bone<br />
loss<br />
2. Partially dentate<br />
• Preservation of rema<strong>in</strong><strong>in</strong>g health teeth<br />
• Complete unilateral loss of teeth <strong>in</strong><br />
one jaw<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Circumcision<br />
Commission<strong>in</strong>g Policy.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/circumcision/<br />
circumcisione.pdf?lang=e<br />
n<br />
Public <strong>Health</strong> <strong>Wales</strong><br />
Evidence-Based<br />
Information<br />
http://www2.nphs.wales.n<br />
hs.uk:8080/healthservice<br />
qdtdocs.nsf/PublicPage?<br />
OpenPage<br />
Royal College of<br />
Surgeons. Guidel<strong>in</strong>es for<br />
select<strong>in</strong>g appropriate<br />
patients to receive<br />
treatment with dental<br />
implants<br />
http://www.rcseng.ac.uk/f<br />
ds/cl<strong>in</strong>ical_guidel<strong>in</strong>es<br />
Circumcision carried out for medical<br />
reasons should be rare and should only<br />
be carried out for urgent medical<br />
conditions.<br />
Circumcision for religious or cultural<br />
reasons should only be carried out and<br />
paid for on a private basis.<br />
The evidence suggests that dental<br />
implants have been shown to be a<br />
successful treatment. However, dental<br />
implant treatment should only be provided<br />
by appropriately tra<strong>in</strong>ed dentists <strong>in</strong><br />
accordance with General Dental<br />
guidance.<br />
29
OPCS Condition Criteria Source of Advice Remarks<br />
D24.- Ear- Cochlear Implants<br />
3. Maxillofacial and cranial defects<br />
• Intraoral protheses e.g. considerable<br />
amounts of miss<strong>in</strong>g hard and soft<br />
tissue<br />
• Extraoral/cranial prostheses e.g.<br />
partial or total loss of ears, eyes or<br />
nose<br />
Should NOT be used EXCEPT <strong>in</strong> the<br />
follow<strong>in</strong>g:<br />
Paediatric cases that meet agreed<br />
audiological, physical and emotional<br />
criteria:<br />
• Bilateral sensor<strong>in</strong>eural hear<strong>in</strong>g loss of<br />
> 90 dBhl at 2 KHz and 4 KHz<br />
• Primary form of communication is<br />
spoken<br />
• Radiological exam<strong>in</strong>ation has<br />
excluded retro – cochlear pathologies<br />
/cerebral defects<br />
• Patient should be fit for general<br />
anaesthesia<br />
• Referrals for accepted for both<br />
acquired and congenital hear<strong>in</strong>g loss<br />
• Parental understand<strong>in</strong>g and<br />
agreement to the long – term<br />
commitment of a cochlear implant<br />
Adult cases that meet agreed<br />
audiological, physical and emotional<br />
criteria:<br />
• Have severe - profound hear<strong>in</strong>g loss<br />
bilaterally with an average hear<strong>in</strong>g<br />
loss > 90 dBhl at 2 KHz and 4 KHz<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Cochlear Implants<br />
Commission<strong>in</strong>g Policy<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/cochlear/coc<br />
hleare.pdf?lang=en<br />
Bilateral Cochlear Implants should not be<br />
used<br />
30
OPCS Condition Criteria Source of Advice Remarks<br />
D03.3<br />
D03.1<br />
D03.2<br />
Ear - Correction of prom<strong>in</strong>ent<br />
ears (P<strong>in</strong>naplasty)<br />
Ear - Remodell<strong>in</strong>g of lobe of<br />
external ear<br />
• Radiological exam<strong>in</strong>ation has<br />
excluded retro – cochlear pathologies /<br />
cerebral defects<br />
• Patient should be fit for general<br />
anaesthesia and surgery<br />
• Have understand<strong>in</strong>g and agreement to<br />
the long – term commitment of a<br />
cochlear implant<br />
Should NOT be used EXCEPT <strong>in</strong> the<br />
follow<strong>in</strong>g criteria:<br />
• The patient must be under the age of<br />
19 at the time of the referral.<br />
• Patients seek<strong>in</strong>g p<strong>in</strong>naplasty should<br />
be seen by a Plastic Surgeon and<br />
follow<strong>in</strong>g assessment, if there is any<br />
concern, assessed by a psychologist.<br />
Should NOT be used EXCEPT for the<br />
repair of totally split ear lobes as a result<br />
of direct trauma.<br />
Prior to surgical correction, patients<br />
should receive pre-operative advice to<br />
<strong>in</strong>form them of:<br />
• Likely success rates.<br />
• The risk of keloid and hypertrophic<br />
scarr<strong>in</strong>g <strong>in</strong> this site.<br />
• The risk of further trauma with re-<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
Children under the age of five are usually<br />
oblivious and referrals may reflect<br />
concerns expressed by the parents rather<br />
than the child.<br />
Correction of split earlobes is not always<br />
successful and the earlobe is a site where<br />
poor scar formation is a recognised risk.<br />
31
OPCS Condition Criteria Source of Advice Remarks<br />
S01.-<br />
X15.1<br />
X15.2<br />
X15.3<br />
X15.8<br />
X15.9<br />
Face - Face or Brow lift<br />
(Rhytidectomy)<br />
Gender Reassignment<br />
Surgery<br />
pierc<strong>in</strong>g of the ear lobule. sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
Should NOT be used EXCEPT for<br />
treatment of:<br />
• Congenital facial abnormalities<br />
• Facial palsy (congenital or acquired<br />
paralysis)<br />
• As part of the treatment of specific<br />
conditions affect<strong>in</strong>g the facial sk<strong>in</strong> e.g.<br />
cutis laxa, pseudoxanthoma elasticum,<br />
neurofibromatosis<br />
• The correction of the consequences of<br />
trauma<br />
• To correct deformity follow<strong>in</strong>g surgery<br />
Should NOT be used EXCEPT for<br />
patients who meet the follow<strong>in</strong>g criteria:<br />
• The patient is at least 18 years; and<br />
• A m<strong>in</strong>imum of 2 years full time<br />
residency <strong>in</strong> <strong>Wales</strong>; and<br />
• Has undergone a m<strong>in</strong>imum of 12<br />
months cont<strong>in</strong>uous hormone therapy<br />
when recommended by a health<br />
professional and provided under the<br />
supervision of a physician; and<br />
• Has completed a period (normally a<br />
m<strong>in</strong>imum of 24 months) of successful<br />
cont<strong>in</strong>uous real-life experience with no<br />
return<strong>in</strong>g to their orig<strong>in</strong>al gender;<br />
<strong>in</strong>clud<strong>in</strong>g one or more of the follow<strong>in</strong>g;<br />
• For patients requir<strong>in</strong>g a mastectomy, a<br />
m<strong>in</strong>imum of 1 year successful<br />
cont<strong>in</strong>uous real-life experience will<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Gender Dysphoria<br />
Commission<strong>in</strong>g Policy.<br />
http://wales.gov.uk/docs/d<br />
hss/policy/090424gender<br />
dysphoriaen.pdf<br />
These procedures will not be used for<br />
purely cosmetic reasons nor to treat the<br />
natural processes of age<strong>in</strong>g. However,<br />
there are a number of specific conditions<br />
for which these procedures may form part<br />
of the treatment to restore appearance<br />
and function.<br />
Written confirmation that the surgeon is<br />
satisfied that the patient meets the<br />
criteria, understands the ramifications and<br />
possible complications of surgery, and<br />
that the surgeon is of the view that the<br />
patient is likely to benefit from surgery is<br />
needed.<br />
Note: A bi-lateral mastectomy would<br />
normally be provided after 12 months on<br />
the pathway unless there are cl<strong>in</strong>ical or<br />
patient reasons not to proceed.<br />
Gender reassignment surgery is<br />
considered not medically necessary when<br />
one or more of the criteria have not been<br />
met.<br />
32
OPCS Condition Criteria Source of Advice Remarks<br />
S60.6<br />
S60.7<br />
Hair - Hair Depilation/<br />
Hirsuitism<br />
have been completed, with no<br />
return<strong>in</strong>g to their orig<strong>in</strong>al gender.<br />
• Ma<strong>in</strong>ta<strong>in</strong> part or full-time employment;<br />
or<br />
• Function as a student <strong>in</strong> an academic<br />
sett<strong>in</strong>g; or<br />
• Function <strong>in</strong> a community-based<br />
volunteer; and<br />
• Acquire a legal gender-identity<br />
appropriate name change; and<br />
• Regular participation <strong>in</strong> psychotherapy<br />
throughout the real-life experience<br />
when recommended by a treat<strong>in</strong>g<br />
medical practitioner; and<br />
• Demonstrable progress <strong>in</strong><br />
consolidat<strong>in</strong>g one’s gender identity<br />
role.<br />
• Demonstrable progress <strong>in</strong> deal<strong>in</strong>g with<br />
work, family and <strong>in</strong>terpersonal issues<br />
result<strong>in</strong>g <strong>in</strong> a significantly better state<br />
of mental health. This implies<br />
satisfactory control of problems such<br />
as sociopathy, substance misuse,<br />
psychosis, suicidality and self harm.<br />
• Demonstrable knowledge of the<br />
required length of hospitalisation, likely<br />
complications and post surgical<br />
rehabilitation<br />
Should NOT be used EXCEPT for<br />
patients who:<br />
• Have undergone reconstructive<br />
surgery lead<strong>in</strong>g to abnormally located<br />
hair-bear<strong>in</strong>g sk<strong>in</strong>.<br />
• Those with a proven underly<strong>in</strong>g<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
The method of depilation (hair removal)<br />
used should be diathermy, electrolysis<br />
performed by a registered electrologist, or<br />
laser centre.<br />
Where laser services are be<strong>in</strong>g developed<br />
33
OPCS Condition Criteria Source of Advice Remarks<br />
C10.3<br />
S33.-<br />
S34.1<br />
S34.2<br />
S34.8<br />
S34.9<br />
Hair - Correction of hair loss<br />
(Alopecia)<br />
Hair - Transplantation<br />
endocr<strong>in</strong>e disturbance result<strong>in</strong>g <strong>in</strong><br />
Hirsutism (e.g. polycystic ovary<br />
syndrome).<br />
• Are undergo<strong>in</strong>g treatment for pilonidal<br />
s<strong>in</strong>uses to reduce recurrence.<br />
• Hirsutism lead<strong>in</strong>g to significant<br />
psychological impairment.<br />
Should NOT be used EXCEPT when<br />
alopecia is a result of previous surgery or<br />
trauma, <strong>in</strong>clud<strong>in</strong>g burns.<br />
Should NOT be used EXCEPT <strong>in</strong><br />
exceptional cases, such as<br />
reconstruction of the eyebrow follow<strong>in</strong>g<br />
cancer or trauma.<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
reference to the available evidence base<br />
should be made.<br />
Should not be used, regardless of gender,<br />
for cosmetic reasons.<br />
34
OPCS Condition Criteria Source of Advice Remarks<br />
X52.1<br />
Hyperbaric Oxygen Therapy<br />
(HBOT) for all <strong>in</strong>dications<br />
Should NOT be used EXCEPT for the<br />
follow<strong>in</strong>g conditions:<br />
• Decompression Illness<br />
• Severe Carbon Monoxide poison<strong>in</strong>g<br />
that has not responded to<br />
conventional<br />
• Normobaric Oxygen therapy.<br />
C46.1 Laser therapy for short sight Should NOT be used EXCEPT if the<br />
patient has a biometry error follow<strong>in</strong>g<br />
cataract surgery<br />
S62.1<br />
S62.2<br />
Liposuction<br />
Should NOT be used EXCEPT it is<br />
sometimes an adjunct to other surgical<br />
procedures. It should not be used simply<br />
to correct the distribution of fat.<br />
Liposuction for chronic lymphoedema<br />
should NOT be used EXCEPT with<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Hyperbaric<br />
oxygen therapy<br />
Commission<strong>in</strong>g Policy.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/hyperbaric/h<br />
yperbarice.pdf?lang=en<br />
NICE Interventional<br />
Procedure Guidance 164<br />
http://www.nice.org.uk/nic<br />
emedia/pdf/ip/IPG164pub<br />
lic<strong>in</strong>fo.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
HCW will only commission emergency<br />
HBOT. HCW will be notified by the<br />
hyperbaric chamber of emergency<br />
admission retrospectively and will not<br />
require prior approval.<br />
HBOT should not be used for:<br />
• Mild / Moderate Carbon Monoxide<br />
Poison<strong>in</strong>g respond<strong>in</strong>g to Normobaric<br />
Oxygen treatment;<br />
• Osteoradionecrosis<br />
• Non – heal<strong>in</strong>g diabetic wounds / ulcers<br />
Current evidence suggests that<br />
photorefractive (laser) surgery for the<br />
correction of refractive errors is safe and<br />
efficacious for use <strong>in</strong> appropriately<br />
selected patients.<br />
However, the safety and effectiveness of<br />
this procedure should be considered<br />
aga<strong>in</strong>st the alternative methods of<br />
correction: spectacles and contact lenses.<br />
Liposuction may be useful for contour<strong>in</strong>g<br />
areas of localised fat atrophy or<br />
pathological hypertrophy (e.g. multiple<br />
lipomatosis, lipodystrophies).<br />
35
OPCS Condition Criteria Source of Advice Remarks<br />
U05.4<br />
U05.5<br />
U21.1<br />
Y98.2<br />
Z66.3<br />
Z66.4<br />
Z66.5<br />
Z66.8<br />
Z67.-<br />
Lower Back Pa<strong>in</strong> (Nonspecific)<br />
– Pla<strong>in</strong> X-rays of<br />
lumbar sp<strong>in</strong>e & MRI scans<br />
Lower Back Pa<strong>in</strong> (Nonspecific)<br />
- General<br />
special arrangements for cl<strong>in</strong>ical<br />
governance, consent and audit or<br />
research.<br />
Should NOT be used EXCEPT <strong>in</strong> the<br />
context of a referral for an op<strong>in</strong>ion on<br />
sp<strong>in</strong>al fusion or if one of the follow<strong>in</strong>g<br />
diagnoses are suspected<br />
• Sp<strong>in</strong>al malignancy<br />
• Infection<br />
• Fracture<br />
• Cauda Equ<strong>in</strong>a Syndrome<br />
• Ankylos<strong>in</strong>g Spondylitis or another<br />
Inflammatory Disorder<br />
The follow<strong>in</strong>g treatments should NOT be<br />
used for the early management of<br />
persistent non-specific low back pa<strong>in</strong>:<br />
• SSRIs for treat<strong>in</strong>g pa<strong>in</strong><br />
• Injections of therapeutic substances<br />
<strong>in</strong>to the back<br />
• Laser therapy<br />
• Interferential therapy<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
NICE Interventional<br />
Procedure Guidance 251<br />
http://www.nice.org.uk/nic<br />
emedia/pdf/IPG251Guida<br />
nce.pdf<br />
NICE Cl<strong>in</strong>ical Guidel<strong>in</strong>e<br />
88<br />
http://www.nice.org.uk/nic<br />
emedia/pdf/CG88NICEG<br />
uidel<strong>in</strong>e.pdf<br />
NICE Cl<strong>in</strong>ical Guidel<strong>in</strong>e<br />
88<br />
http://www.nice.org.uk/nic<br />
emedia/pdf/CG88NICEG<br />
uidel<strong>in</strong>e.pdf<br />
36
OPCS Condition Criteria Source of Advice Remarks<br />
C88.2 Photodynamic Therapy (PDT)<br />
for wet age-related macular<br />
degeneration<br />
• Therapeutic ultrasound<br />
• TENS<br />
• Lumbar supports<br />
• Traction<br />
The follow<strong>in</strong>g referrals should NOT be<br />
offered for the early management of<br />
persistent non-specific low back pa<strong>in</strong>:<br />
• Radiofrequency facet jo<strong>in</strong>t denervation<br />
• IDET<br />
• PIRFT<br />
Should NOT be used EXCEPT for<br />
<strong>in</strong>dividuals who have a confirmed<br />
diagnosis of classic with no occult<br />
subfoveal choroidal neovascularisation<br />
(CNV) (that is, whose lesions are<br />
composed of classic CNV with no<br />
evidence of an occult component) and<br />
best-corrected visual acuity 6/60 or<br />
better<br />
NICE Technology<br />
Appraisal 68<br />
http://guidance.nice.org.u<br />
k/TA68<br />
PDT is NOT recommended for the<br />
treatment of people with predom<strong>in</strong>antly<br />
classic subfoveal CNV (that is, 50% or<br />
more of the entire area of the lesion is<br />
classic CNV but some occult CNV is<br />
present) associated with wet age related<br />
macular degeneration, except as part of<br />
research.<br />
37
OPCS Condition Criteria Source of Advice Remarks<br />
S60.1<br />
S60.2<br />
S10.3<br />
S11.3<br />
S60.4<br />
Y06.4<br />
S06.5<br />
OR<br />
S06.9<br />
+<br />
Y06.4<br />
S23.1<br />
S23.2<br />
S23.3<br />
S23.4<br />
Rh<strong>in</strong>ophyma – Surgery or<br />
Laser treatment<br />
Scar revision<br />
Should NOT be used EXCEPT for<br />
severe cases or those that do not<br />
respond to medical treatment<br />
Should NOT be used EXCEPT for<br />
treatment of scars which <strong>in</strong>terfere with<br />
function follow<strong>in</strong>g burns or treatments for<br />
keloid or post surgical scarr<strong>in</strong>g<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
The first-l<strong>in</strong>e treatment of this disfigur<strong>in</strong>g<br />
condition of the nasal sk<strong>in</strong> is medical.<br />
38
OPCS Condition Criteria Source of Advice Remarks<br />
S60.1<br />
S60.2<br />
Q29.1<br />
Q29.2<br />
Q29.8<br />
Q29.9<br />
Sk<strong>in</strong> hypo-pigmentation The recommended NHS suitable<br />
treatment for hypo-pigmentation is<br />
cosmetic camouflage. Access to a<br />
qualified camouflage beautician should<br />
be available on the NHS for this and<br />
other sk<strong>in</strong> conditions requir<strong>in</strong>g<br />
camouflage.<br />
Sk<strong>in</strong> “Resurfac<strong>in</strong>g<br />
Techniques” – laser,<br />
dermabrasion & dermal peels<br />
Sterilisation – Reversal of<br />
(male and female)<br />
Should NOT be used EXCEPT for posttraumatic<br />
scarr<strong>in</strong>g (<strong>in</strong>clud<strong>in</strong>g postsurgical)<br />
OR severe acne scarr<strong>in</strong>g once<br />
the active disease is controlled.<br />
Should NOT be used EXCEPT <strong>in</strong> the<br />
follow<strong>in</strong>g circumstances:<br />
• If death of an exist<strong>in</strong>g child has<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
Public <strong>Health</strong> <strong>Wales</strong><br />
Evidence-Based<br />
Information<br />
The evidence suggests that reversal of<br />
sterilisation for both females and males<br />
appear to be effective methods of<br />
restor<strong>in</strong>g fertility. Those seek<strong>in</strong>g<br />
39
OPCS Condition Criteria Source of Advice Remarks<br />
Q37.1<br />
Q37.8<br />
Q37.9<br />
N17.1<br />
S09.2<br />
Tattoo removal<br />
occurred<br />
• Remarriage follow<strong>in</strong>g death of spouse<br />
• Loss of unborn child when vasectomy<br />
has taken place dur<strong>in</strong>g the pregnancy<br />
Should NOT be used EXCEPT <strong>in</strong> the<br />
follow<strong>in</strong>g circumstances:<br />
• Where the tattoo is the result of<br />
trauma, <strong>in</strong>flicted aga<strong>in</strong>st the patient’s<br />
will (“rape tattoo”).<br />
• The patient was not Gillick competent,<br />
and therefore not responsible for their<br />
actions at the time of the tattoo<strong>in</strong>g.<br />
• Exceptions may also be made for<br />
tattoos <strong>in</strong>flicted under duress dur<strong>in</strong>g<br />
adolescence or disturbed periods<br />
where it is considered that<br />
psychological rehabilitation, break up<br />
of family units or prolonged<br />
unemployment could be avoided,<br />
given the treatment opportunity.<br />
(Only considered <strong>in</strong> very exceptional<br />
circumstances where the tattoo<br />
causes marked limitations of<br />
http://www2.nphs.wales.n<br />
hs.uk:8080/healthservice<br />
qdtdocs.nsf/PublicPage?<br />
OpenPage<br />
Royal College of<br />
obstetricians and<br />
Gynaecologists. Male and<br />
female sterilisation.<br />
Guidel<strong>in</strong>e Summary.<br />
http://www.rcog.org.uk/wo<br />
mens-health/cl<strong>in</strong>icalguidance/male-andfemale<br />
sterilisation<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
sterilisation should be fully advised and<br />
counselled <strong>in</strong> accordance with Royal<br />
College of Obstetricians and<br />
Gynaecologists guidel<strong>in</strong>es that the<br />
procedure is <strong>in</strong>tended to be permanent.<br />
However, this procedure is not generally<br />
supported. Any provider carry<strong>in</strong>g out<br />
sterilisation procedures should make it<br />
clear it will not be reversed on the NHS.<br />
40
OPCS Condition Criteria Source of Advice Remarks<br />
S09.1<br />
S09.2<br />
C12.1<br />
C12.2<br />
C12.3<br />
psychosocial function).<br />
Vascular sk<strong>in</strong> lesions NHS treatment is allowed for all vascular<br />
lesions except for small benign, acquired<br />
vascular lesions such as thread ve<strong>in</strong>s<br />
and spider naevi.<br />
Xanthelasma Palpebrum<br />
(Fatty deposits on the eyelids)<br />
Should NOT be used EXCEPT for larger<br />
lesions OR those that have not<br />
responded to these treatments AND if<br />
the lesion is disfigur<strong>in</strong>g.<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/p<br />
ublications/healthcommis<br />
sion/policies/plasticsurger<br />
y/plasticsurgerye.pdf<br />
The plann<strong>in</strong>g of treatment of complex<br />
major vascular malformations is best<br />
carried out <strong>in</strong> a specialised multidiscipl<strong>in</strong>ary<br />
team sett<strong>in</strong>g.<br />
The follow<strong>in</strong>g treatments should be<br />
considered for patients with xanthelasma:<br />
• Many Xanthelasma may be treated<br />
with topical trichloroacetic acid (TCA)<br />
or cryotherapy<br />
• Xanthelasma may be associated with<br />
abnormally high cholesterol levels and<br />
this should be tested for before referral<br />
to a specialist<br />
• Patients with xanthelasma should<br />
always have their lipid profile checked<br />
before referral to a specialist.<br />
41
4. HIGHER VOLUME procedures which should NOT be used by the NHS EXCEPT under strict criteria<br />
OPCS Condition Criteria Source of advice Remarks<br />
F12.1<br />
Q131 N34.2<br />
Q132 N34.4<br />
Apicectomy<br />
Assisted conception<br />
techniques – IVF, ICSI, Donor<br />
Insem<strong>in</strong>ation, MESA, TESE,<br />
Should NOT be used EXCEPT <strong>in</strong> the<br />
follow<strong>in</strong>g circumstances:<br />
• Presence of periradicular disease, with<br />
or without symptoms <strong>in</strong> a root filled<br />
tooth, where non surgical root canal<br />
re-treatment cannot be undertaken or<br />
has failed, or where conventional retreatment<br />
may be detrimental to the<br />
retention of the tooth<br />
• Presence of periradicular disease <strong>in</strong> a<br />
tooth where iatrogenic or<br />
developmental anomalies prevent non<br />
surgical root canal treatment be<strong>in</strong>g<br />
undertaken.<br />
• Where a biopsy of periradicular tissue<br />
is needed<br />
• Where visualisation of the periradicular<br />
tissues and tooth root is required when<br />
perforation, root crack or fracture is<br />
suspected<br />
• Where procedures are required that<br />
need either tooth section<strong>in</strong>g or root<br />
amputation<br />
• Where it may not be expedient to<br />
undertake prolonged non-surgical root<br />
canal re-treatment because of patient<br />
considerations.<br />
See HCW Policy for criteria<br />
Public <strong>Health</strong> <strong>Wales</strong><br />
Evidence-Based<br />
Information<br />
http://www2.nphs.wales.n<br />
hs.uk:8080/healthservice<br />
qdtdocs.nsf/PublicPage?<br />
OpenPage<br />
Royal College of<br />
Surgeons of England.<br />
Guidel<strong>in</strong>es for surgical<br />
endodontics<br />
http://www.rcseng.ac.uk/f<br />
ds/cl<strong>in</strong>ical_guidel<strong>in</strong>es/doc<br />
uments/surg_end_guideli<br />
ne.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
The evidence suggests that the success<br />
rate of apical surgery on molar teeth is<br />
low.<br />
43
OPCS Condition Criteria Source of advice Remarks<br />
Q133 N34.5<br />
Q134 N34.6<br />
Q135<br />
Q136<br />
Q137<br />
Q138<br />
Q139<br />
Q383<br />
S06.5<br />
S06.9<br />
S09.1<br />
S09.2<br />
S11.1<br />
S11.2<br />
PESA. Egg sperm & gonadal<br />
tissue cryostorage, Other<br />
micro-manipulation<br />
techniques, Egg donation<br />
where no other treatment is<br />
available, IVF surrogacy<br />
Benign sk<strong>in</strong> conditions –<br />
Removal of Lipomata<br />
As above Benign sk<strong>in</strong> conditions –<br />
Removal of Viral warts<br />
Should NOT be used EXCEPT <strong>in</strong> the<br />
follow<strong>in</strong>g circumstances:<br />
• The lipoma (-ta) is / are symptomatic<br />
• There is functional impairment<br />
• The lump is rapidly grow<strong>in</strong>g or<br />
abnormally located (e.g. sub-fascial,<br />
sub-muscular)<br />
Pa<strong>in</strong>ful, persistent or extensive warts<br />
(particularly <strong>in</strong> the immunosuppressed<br />
patient) may need specialist assessment,<br />
by a dermatologist. For a small<br />
proportion surgical removal (cryotherapy,<br />
cautery, laser or excision) may be<br />
appropriate.<br />
Policy Specialist Fertility<br />
Services<br />
http://wales.gov.uk/docs/<br />
dhss/publications/091116<br />
commission<strong>in</strong>gpolicyspec<br />
ialisedfertilityen.doc<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/<br />
publications/healthcommi<br />
ssion/policies/plasticsurg<br />
ery/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/<br />
Most viral warts will clear spontaneously<br />
or follow<strong>in</strong>g application of topical<br />
treatments.<br />
44
OPCS Condition Criteria Source of advice Remarks<br />
As above Benign sk<strong>in</strong> conditions – other<br />
e.g. benign pigmented moles,<br />
milia, sk<strong>in</strong> tags, molluscum<br />
contagiosum, keratoses<br />
(basal cell papillomata),<br />
sebaceous cysts,<br />
corns/callous,<br />
dermatofibromas, comedones<br />
B31.1<br />
B31.4<br />
Breast - Female Breast<br />
Reduction (Reduction<br />
mammoplasty)<br />
Cl<strong>in</strong>ically benign sk<strong>in</strong> lesions should not<br />
be removed on purely cosmetic grounds.<br />
This will <strong>in</strong>clude, amongst other<br />
conditions, sk<strong>in</strong> tags and seborrhoeic<br />
keratoses (warts).<br />
Patients with moderate to large lesions<br />
that cause actual facial disfigurement<br />
may benefit from surgical excision. The<br />
risks of scarr<strong>in</strong>g must be balanced<br />
aga<strong>in</strong>st the appearance of the lesion.<br />
Epidermoid or pillar cysts (commonly<br />
known as “Sebaceous cysts”) are always<br />
benign but some may become <strong>in</strong>fected or<br />
be symptomatic. Some may require<br />
surgical excision particularly if large or<br />
located on the face or on a site where<br />
they are subjected to trauma.<br />
Should NOT be used EXCEPT if ALL the<br />
follow<strong>in</strong>g circumstances are met:<br />
• The patient is suffer<strong>in</strong>g from neck<br />
ache, backache and/or severe<br />
<strong>in</strong>tertrigo<br />
• The wear<strong>in</strong>g of a professionally fitted<br />
brassiere has not relieved the<br />
symptoms<br />
• The patient has a body mass <strong>in</strong>dex<br />
(BMI) of 25Kg/m2 or less<br />
publications/healthcommi<br />
ssion/policies/plasticsurg<br />
ery/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/<br />
publications/healthcommi<br />
ssion/policies/plasticsurg<br />
ery/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/<br />
publications/healthcommi<br />
ssion/policies/plasticsurg<br />
Only <strong>in</strong> very exceptional circumstances<br />
will girls under the age of 16 be<br />
considered for this procedure.<br />
Follow<strong>in</strong>g <strong>in</strong>itial consideration of the<br />
referral by the Case Officer or equivalent,<br />
appropriate patients should ideally have<br />
an <strong>in</strong>itial assessment prior to an<br />
appo<strong>in</strong>tment with a Consultant Plastic<br />
Surgeon to ensure that these criteria are<br />
met. (In the future consideration may be<br />
given to evaluat<strong>in</strong>g the benefits of hav<strong>in</strong>g<br />
45
OPCS Condition Criteria Source of advice Remarks<br />
B30.- Breast -Prosthesis Removal<br />
or Replacement<br />
R17.-<br />
Caesarian Section (CS) -<br />
Elective<br />
Should NOT be used EXCEPT if the<br />
NHS performed the orig<strong>in</strong>al surgery and<br />
complications arise.<br />
Should NOT be used EXCEPT <strong>in</strong> the<br />
follow<strong>in</strong>g circumstances:<br />
• A term s<strong>in</strong>gleton breech (if external<br />
cephalic version is contra<strong>in</strong>dicated or<br />
has failed)<br />
• A tw<strong>in</strong> pregnancy with breech first tw<strong>in</strong><br />
• HIV (only if recommended by a HIV<br />
consultant)<br />
• Both HIV and hepatitis C (as above,<br />
there is no evidence that CS should be<br />
performed for hepatitis C alone)<br />
• Primary genital herpes <strong>in</strong> the third<br />
trimester (active genital herpes at the<br />
onset of labour)<br />
• Grade 3 and 4 placential praevia<br />
• Two previous caesarian sections or<br />
ery/plasticsurgerye.pdf<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/<br />
publications/healthcommi<br />
ssion/policies/plasticsurg<br />
ery/plasticsurgerye.pdf<br />
NICE Cl<strong>in</strong>ical Guidel<strong>in</strong>e<br />
13<br />
http://www.nice.org.uk/pa<br />
ge.aspx?o=113190<br />
access to a tra<strong>in</strong>ed bra fitter and<br />
<strong>in</strong>troduc<strong>in</strong>g laser scann<strong>in</strong>g of the thorax).<br />
Patients should be made aware that<br />
implant removal <strong>in</strong> the future might not be<br />
automatically followed by replacement of<br />
the implant. If revisional surgery is be<strong>in</strong>g<br />
carried out for implant failure, the decision<br />
to replace the implant(s) rather than<br />
simply remove them will be based upon<br />
the cl<strong>in</strong>ical need for replacement and<br />
whether the patient meets the policy for<br />
augmentation at the time of revision.<br />
When consider<strong>in</strong>g a CS, there should be<br />
a discussion on the benefits and risks of<br />
CS compared with vag<strong>in</strong>al birth specific to<br />
the woman and her pregnancy. Maternal<br />
request is not on its own an <strong>in</strong>dication for<br />
CS and specific reasons for the request<br />
should be explored, discussed and<br />
recorded. When a woman requests a CS<br />
<strong>in</strong> the absence of an identifiable reason,<br />
the overall benefits and risks of CS<br />
compared with vag<strong>in</strong>al birth should be<br />
discussed and recorded.<br />
46
OPCS Condition Criteria Source of advice Remarks<br />
J18.-<br />
C13.1<br />
C13.2<br />
C13.3<br />
C13.4<br />
C13.8<br />
C13.9<br />
C15.1<br />
C15.2<br />
C12.1<br />
C12.2<br />
C12.3<br />
C12.4<br />
C12.5<br />
Cholecystectomy (for<br />
asymptomatic gall stones)<br />
Eyelid - Blepharoplasty<br />
more<br />
• Previous upper segment caesarean<br />
section or type unknown<br />
• Previous significant uter<strong>in</strong>e<br />
perforation/ surgery breach<strong>in</strong>g the<br />
cavity<br />
Should NOT be used EXCEPT <strong>in</strong><br />
patients who are at <strong>in</strong>creased risk of<br />
develop<strong>in</strong>g gallbladder carc<strong>in</strong>oma or<br />
gallstone complications<br />
Surgery on the upper eyelid should NOT<br />
be used EXCEPT to correct functional<br />
impairment (not purely for cosmetic<br />
reasons), as demonstrated by:<br />
• Impairment of visual fields <strong>in</strong> the<br />
relaxed, non-compensated state.<br />
• Cl<strong>in</strong>ical observation of poor eyelid<br />
function, discomfort e.g. headache<br />
worsen<strong>in</strong>g towards the end of the day<br />
and / or evidence of chronic<br />
compensation through elevation of the<br />
brow.<br />
Surgery on the lower eyelid should NOT<br />
be used EXCEPT for:<br />
• correction of ectropion or entropion<br />
• for the removal of lesions of the eyelid<br />
Public <strong>Health</strong> <strong>Wales</strong><br />
Evidence-Based<br />
Information<br />
http://www2.nphs.wales.n<br />
hs.uk:8080/healthservice<br />
qdtdocs.nsf/PublicPage?<br />
OpenPage<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service.<br />
http://wales.gov.uk/dhss/<br />
publications/healthcommi<br />
ssion/policies/plasticsurg<br />
ery/plasticsurgerye.pdf<br />
There is <strong>in</strong>sufficient evidence of cl<strong>in</strong>ical<br />
effectiveness of cholecystectomy (for<br />
asymptomatic gall stones).<br />
Excess sk<strong>in</strong> <strong>in</strong> the upper eyelids can<br />
accumulate due to the age<strong>in</strong>g and is thus<br />
normal. Hooded lids caus<strong>in</strong>g significant<br />
functional impaired vision confirmed by an<br />
appropriate specialist can warrant surgical<br />
treatment. Impairment to visual field to be<br />
documented<br />
Excessive sk<strong>in</strong> <strong>in</strong> the lower lid may cause<br />
“eye bags” but does not affect function of<br />
the eyelid or vision and therefore does not<br />
need correction.<br />
47
OPCS Condition Criteria Source of advice Remarks<br />
T59.-<br />
T60.-<br />
D15.1<br />
Ganglia – Surgical Removal<br />
Grommets - Dra<strong>in</strong>age of<br />
middle ear <strong>in</strong> otitis media with<br />
effusion (OME)<br />
sk<strong>in</strong> or lid marg<strong>in</strong>.<br />
Should NOT be used EXCEPT if the<br />
ganglion is very pa<strong>in</strong>ful and restricts work<br />
and hobbies (subject to specialist<br />
surgical assessment and advice).<br />
Should NOT be used EXCEPT where:<br />
There has been a period of at least three<br />
months watchful wait<strong>in</strong>g from the date of<br />
the first appo<strong>in</strong>tment with an audiologist<br />
or GP with special <strong>in</strong>terest <strong>in</strong> ENT<br />
AND the child is placed on a wait<strong>in</strong>g list<br />
for the procedure at the end of this<br />
period;<br />
AND OME persists after three months<br />
AND the child (who must be over three<br />
years of age) suffers from at least one of<br />
the follow<strong>in</strong>g:<br />
• At least 3-5 recurrences of acute otitis<br />
media <strong>in</strong> a year<br />
• Evidence of delay <strong>in</strong> speech<br />
development<br />
• Educational or behavioural problems<br />
attributable to persistent hear<strong>in</strong>g<br />
impairment, with a hear<strong>in</strong>g loss of at<br />
least 25dB particularly <strong>in</strong> the lower<br />
tones (low frequency loss)<br />
• A significant second disability such as<br />
Downs syndrome<br />
Public <strong>Health</strong> <strong>Wales</strong><br />
Evidence-Based<br />
Information<br />
http://www2.nphs.wales.n<br />
hs.uk:8080/healthservice<br />
qdtdocs.nsf/PublicPage?<br />
OpenPage<br />
NICE cl<strong>in</strong>ical guidel<strong>in</strong>e 60<br />
http://www.nice.org.uk/nic<br />
emedia/pdf/CG60fullguid<br />
el<strong>in</strong>e.pdf<br />
The evidence suggests that there is a<br />
high rate of spontaneous resolution for<br />
ganglia and that reassurance should be<br />
the first therapeutic <strong>in</strong>tervention for most<br />
patients and all children<br />
Insertion of grommets is one of the five<br />
surgical procedures that the Department<br />
of <strong>Health</strong> monitors as <strong>in</strong>dicators of excess<br />
surgical activity.<br />
48
OPCS Condition Criteria Source of advice Remarks<br />
H51.-<br />
H52.-<br />
Q10.3<br />
Q10.8<br />
Q10.9<br />
Q07.-<br />
Q08.-<br />
Haemorrhoidectomy<br />
Heavy Menstrual Bleed<strong>in</strong>g -<br />
Dilation and curettage (D&C)/<br />
Hysteroscopy<br />
Heavy Menstrual Bleed<strong>in</strong>g -<br />
Hysterectomy<br />
Should NOT be used EXCEPT <strong>in</strong> cases<br />
of:<br />
• Recurrent haemorrhoids<br />
• Persistent bleed<strong>in</strong>g<br />
• Failed conservative treatment<br />
D&C should NOT be used as a<br />
therapeutic treatment or as a diagnostic<br />
tool for heavy menstrual bleed<strong>in</strong>g so will<br />
not receive prior approval for these<br />
conditions.<br />
Hysteroscopy should NOT be used<br />
EXCEPT when it is carried out:<br />
• As an <strong>in</strong>vestigation for structural and<br />
histological abnormalities where<br />
ultrasound has been used as the first<br />
l<strong>in</strong>e diagnostic tool and where the<br />
outcomes are <strong>in</strong>conclusive<br />
• When undertak<strong>in</strong>g endometrial<br />
ablation<br />
Should NOT be used EXCEPT when:<br />
• Other treatment options have failed,<br />
are contra<strong>in</strong>dicated or are decl<strong>in</strong>ed by<br />
the woman<br />
• There is a wish for amenorrhoea<br />
• The woman (who has been fully<br />
<strong>in</strong>formed) requests it<br />
Public <strong>Health</strong> <strong>Wales</strong><br />
Evidence-Based<br />
Information<br />
http://www2.nphs.wales.n<br />
hs.uk:8080/healthservice<br />
qdtdocs.nsf/PublicPage?<br />
OpenPage<br />
NICE Cl<strong>in</strong>ical Guidel<strong>in</strong>e<br />
44<br />
http://guidance.nice.org.u<br />
k/CG44<br />
NICE Cl<strong>in</strong>ical Guidel<strong>in</strong>e<br />
44<br />
http://guidance.nice.org.u<br />
k/CG44<br />
The evidence suggests that first and<br />
second degree haemorrhoids are<br />
classically treated with some form of nonsurgical<br />
ablative/ fixative <strong>in</strong>tervention,<br />
third degree treated with rubber band<br />
ligation or haemorrhoidectomy, and fourth<br />
degree with haemorrhoidectomy.<br />
Dilation and curettage is one of the five<br />
surgical procedures that the Department<br />
of <strong>Health</strong> monitors as <strong>in</strong>dicators of excess<br />
surgical activity.<br />
Hysterectomy is one of the five surgical<br />
procedures that the Department of <strong>Health</strong><br />
monitors as <strong>in</strong>dicators of excess surgical<br />
activity.<br />
49
OPCS Condition Criteria Source of advice Remarks<br />
E02.3<br />
E02.5<br />
E02.6<br />
E07.3<br />
F14.-<br />
F15.-<br />
F34.1<br />
F34.2<br />
F34.3<br />
F34.4<br />
F34.5<br />
F34.6<br />
F34.7<br />
Nose - Rh<strong>in</strong>oplasty<br />
Orthodontic treatments of<br />
essentially cosmetic nature<br />
Tonsillectomy – children &<br />
adults<br />
• The woman no longer wishes to reta<strong>in</strong><br />
her uterus and fertility<br />
Should NOT be used EXCEPT for:<br />
• Problems caused by obstruction of the<br />
nasal airway.<br />
• Objective nasal deformity caused by<br />
trauma.<br />
• Correction of complex congenital<br />
conditions e.g. cleft lip and palate.<br />
Priority will be based on those with high<br />
Index of Orthodontic Treatment Need<br />
Scores - 5,4 and 3 where a significant<br />
aesthetic component can be<br />
demonstrated and those with other major<br />
conditions e.g. craniofacial<br />
deformity/cancers<br />
Should NOT be used EXCEPT if patients<br />
meet ALL of the follow<strong>in</strong>g criteria prior to<br />
referral:<br />
• Sore throat is due to tonsillitis<br />
• Five or more episodes of sore throat<br />
per year<br />
<strong>Health</strong> Commission<br />
<strong>Wales</strong>. Commission<strong>in</strong>g<br />
Criteria – Plastic Surgery.<br />
Procedures of Low<br />
Cl<strong>in</strong>ical Priority/<br />
Procedures not usually<br />
available on the National<br />
<strong>Health</strong> Service<br />
http://wales.gov.uk/dhss/<br />
publications/healthcommi<br />
ssion/policies/plasticsurg<br />
ery/plasticsurgerye.pdf<br />
<strong>Health</strong> Evidence Bullet<strong>in</strong><br />
<strong>Wales</strong> Oral <strong>Health</strong><br />
http://hebw.cf.ac.uk/oralh<br />
ealth/<strong>in</strong>dex.html<br />
Royal College of<br />
Paediatrics and Child<br />
<strong>Health</strong>. Guidel<strong>in</strong>es for<br />
good practice.<br />
Management of acute<br />
and recurr<strong>in</strong>g sore throat<br />
and <strong>in</strong>dications for<br />
Patients with isolated airway problems (<strong>in</strong><br />
the absence of visible nasal deformity)<br />
may be referred <strong>in</strong>itially to an Ear Nose<br />
and Throat (ENT) consultant for<br />
assessment and treatment.<br />
Evidence based on expert op<strong>in</strong>ion<br />
suggests that orthodontic treatment<br />
should be directed at those <strong>in</strong>dividuals <strong>in</strong><br />
which the greatest benefit can be<br />
achieved.<br />
Once a decision is made for<br />
tonsillectomy, this should be performed as<br />
soon as possible, to maximise the period<br />
of benefit before natural resolution of<br />
symptoms might occur<br />
Tonsillectomy is one of the five surgical<br />
50
OPCS Condition Criteria Source of advice Remarks<br />
F34.8<br />
F34.9<br />
L84.-<br />
L85.-<br />
L86.-<br />
L87.-<br />
L88.-<br />
F09.1.<br />
F09.3.<br />
Varicose Ve<strong>in</strong>s –<br />
asymptomatic &<br />
mild/moderate cases<br />
Wisdom teeth - Removal of<br />
asymptomatic<br />
• Symptoms for at least one year<br />
• Episodes of sore throat are disabl<strong>in</strong>g<br />
and prevent normal function<strong>in</strong>g<br />
A six-month period of watchful wait<strong>in</strong>g is<br />
recommended prior to tonsillectomy to<br />
establish firmly the patterns of symptoms<br />
and allow the patient to consider fully the<br />
implications of the operation<br />
Should NOT be used EXCEPT <strong>in</strong> the<br />
follow<strong>in</strong>g circumstances:<br />
• ulcers/history of ulcers secondary to<br />
superficial venous disease<br />
• liposclerosis<br />
• varicose eczema<br />
• history of phlebitis<br />
Should NOT be used EXCEPT <strong>in</strong> cases<br />
where there is evidence of pathology<br />
tonsillectomy.<br />
http://www.rcpch.ac.uk/do<br />
c.aspx?id_Resource=171<br />
4<br />
Referral Advice National<br />
Institute for Cl<strong>in</strong>ical<br />
Excellence.<br />
http://www.nice.org.uk/m<br />
edia/A8F/DC/Referraladvi<br />
ce.pdf<br />
London <strong>Health</strong><br />
Observatory<br />
http://www.lho.org.uk/co<br />
mmission<strong>in</strong>g/PCTCl<strong>in</strong>ical<br />
Exceptions.aspx<br />
NICE Technology<br />
Appraisal 1<br />
http://guidance.nice.org.u<br />
k/TA1<br />
London <strong>Health</strong><br />
Observatory<br />
http://www.lho.org.uk/co<br />
mmission<strong>in</strong>g/PCTCl<strong>in</strong>ical<br />
procedures that the Department of <strong>Health</strong><br />
monitors as <strong>in</strong>dicators of excess surgical<br />
activity.<br />
Evidence from recent population surveys<br />
<strong>in</strong>dicates very little relationship between<br />
symptoms and varicose ve<strong>in</strong>s –<br />
substantial numbers of patients without<br />
varicose ve<strong>in</strong>s have similar symptoms<br />
Most varicose ve<strong>in</strong>s require no treatment.<br />
The most common compla<strong>in</strong>t about<br />
varicose ve<strong>in</strong>s is their appearance. When<br />
bleed<strong>in</strong>g or ulceration occurs referral may<br />
be appropriate and of that number some<br />
may benefit from surgical <strong>in</strong>tervention.<br />
Impacted wisdom teeth free from disease<br />
should not be operated on.<br />
51
OPCS Condition Criteria Source of advice Remarks<br />
Exceptions.aspx<br />
52
5. New, experimental and miscellaneous treatments which<br />
should NOT be used by the NHS EXCEPT under strict<br />
criteria<br />
New and experimental treatments will be judged on an <strong>in</strong>dividual basis. NICE will<br />
be the def<strong>in</strong>itive guidance where available. However, it is recognised that many<br />
new treatments have not been subject to NICE. In such cases other recognised<br />
expert appraisals will be used as guidance <strong>in</strong>clud<strong>in</strong>g Cochrane, SIGN, SMC, the<br />
London Cancer Consortium and Public <strong>Health</strong> <strong>Wales</strong> Evidence-Based<br />
Information. The LHB will also be guided by research subject to <strong>in</strong>ternal and<br />
external evaluation of its merit through the New Technologies Oversight Process.<br />
6. Acknowledgements<br />
The authors would like to thank the follow<strong>in</strong>g for their help and advice:<br />
<strong>Betsi</strong> <strong>Cadwaladr</strong> <strong>University</strong> <strong>Health</strong> <strong>Board</strong> – Brian Tehan, Medwyn Williams<br />
D&A Consultancy - Denise McCafferty<br />
<strong>Health</strong> Commission <strong>Wales</strong> - Hugo Van Woerden, Kamala Williams<br />
<strong>Health</strong> Solutions <strong>Wales</strong> – Sian Davies<br />
Public <strong>Health</strong> <strong>Wales</strong> - Paul Tromans, Nigel Monaghan, Norma Prosser, Mary<br />
Webb, D<strong>in</strong>ah Roberts, Sian K<strong>in</strong>g, Claire Jones, Siobhan Jones, Jo Charles,<br />
Ciaran Humphreys, Hugo Cosh, Hannah Lloyd, Ken Jones, Sandra Sandham<br />
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programme NICE Cl<strong>in</strong>ical Guidel<strong>in</strong>e 13. London: NICE, 2008<br />
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revascularisation for refractory ang<strong>in</strong>a pectoris. NICE Interventional<br />
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23. National Institute <strong>Health</strong> and Cl<strong>in</strong>ical Excellence. Low back pa<strong>in</strong>. NICE<br />
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24. National Institute <strong>Health</strong> and Cl<strong>in</strong>ical Excellence. Soft palate implants for<br />
obstructive sleep apnoea. NICE Interventional Procedure Guidance 241<br />
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25. National Institute <strong>Health</strong> and Cl<strong>in</strong>ical Excellence. Liposuction for chronic<br />
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evidence-based summary - Autologous chondrocyte implantation for ankle<br />
jo<strong>in</strong>ts. Cardiff: NPHS, 2009<br />
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evidence-based summary - Haemorrhoidectomy. Cardiff: NPHS, 2009<br />
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29. Prosser N and National Public <strong>Health</strong> Service for <strong>Wales</strong>. Public health<br />
evidence-based summary -Reversal of sterilisation. Cardiff: NPHS, 2009<br />
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30. Prosser N and National Public <strong>Health</strong> Service for <strong>Wales</strong>. Public health<br />
evidence-based summary -Therapeutic use of Ultrasound <strong>in</strong> hip and knee<br />
osteoarthritis. Cardiff: NPHS, 2009<br />
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31. Prosser N and National Public <strong>Health</strong> Service for <strong>Wales</strong>. Public health<br />
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Medic<strong>in</strong>e Cardiff: NPHS, 2009<br />
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32. Prosser N and National Public <strong>Health</strong> Service for <strong>Wales</strong>. Public health<br />
evidence-based summary – Dental Implants Cardiff: NPHS, 2009<br />
Available at:<br />
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Cardiff: NPHS, 2009<br />
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London: RCS, 2001<br />
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receive treatment with dental implants: priorities for the NHS. London: RCS,<br />
1997<br />
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Conwy <strong>Local</strong> <strong>Health</strong> <strong>Board</strong>. Procedures of Limited Cl<strong>in</strong>ical Effectiveness. Colwyn<br />
Bay: Conwy LHB; 2007.<br />
Conwy <strong>Local</strong> <strong>Health</strong> <strong>Board</strong>. Effective use of resources: Interventions of limited or<br />
unknown cl<strong>in</strong>ical value (draft). Conwy <strong>Local</strong> <strong>Health</strong> <strong>Board</strong>, 2007. Available at:<br />
http://www.wales.nhs.uk/sites3/Documents/271/Procedures%20of%20limited%20<br />
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Fl<strong>in</strong>tshire <strong>Local</strong> <strong>Health</strong> <strong>Board</strong>. Procedures of Limited Cl<strong>in</strong>ical Effectiveness.<br />
Mold: Fl<strong>in</strong>tshire LHB; 2007.Available at:<br />
BCULHB Draft IPC Procedure 57 18th February<br />
2010
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NHS North Staffordshire. Low Priority Treatments – Commission<strong>in</strong>g Policy. Leek:<br />
NHS North Staffordshire; 2009. Available at:<br />
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February 2010]<br />
Leicester City Primary Care Trust. Low Priority Treatment Policy. Leicester:<br />
Leicester City PCT; 2008.Available at:<br />
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webpage [onl<strong>in</strong>e].Available at:<br />
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February 2010]<br />
National Public <strong>Health</strong> Service. Treatments that should not be done either at all<br />
or unless strict criteria are adhered to. Cardiff: NPHS; 2010.<br />
Available at:<br />
http://www2.nphs.wales.nhs.uk:8080/healthserviceqdtdocs.nsf/($All)/C455EA251<br />
897B54F80257089004EE9B6/$File/NICElimitedeffectiverec.doc?OpenElement<br />
[Accessed 24 th February 2010]<br />
NHS Contract & Information Shared Services Unit. Draft Cheshire & Merseyside<br />
Prior Approval Scheme Incorporat<strong>in</strong>g Procedures of Lower Cl<strong>in</strong>ical Priority<br />
(PLCP), CISSU, 2010.<br />
NHS Contract & Information Shared Services Unit. Draft Cheshire & Merseyside<br />
Prior Approval Scheme Incorporat<strong>in</strong>g Procedures of Lower Cl<strong>in</strong>ical Priority<br />
(PLCP) Proposed Cod<strong>in</strong>g<br />
Available at: http://www.cissu.co.uk/<strong>in</strong>dex.html<br />
Powys <strong>Local</strong> <strong>Health</strong> <strong>Board</strong> Policy on Contract Exclusions (Procedures of Limited<br />
Cl<strong>in</strong>ical Effectiveness), 2007.<br />
Western Cheshire Primary Care Trust. Procedures of Limited Cl<strong>in</strong>ical Value.<br />
Chester: Western Cheshire PCT; 2009.<br />
Available at:<br />
http://www.westcheshirehealthconsortium.nhs.uk/document_uploads/Other_Docu<br />
ments/Procedures_Limited_Cl<strong>in</strong>ical_Value.doc [Accessed 24 th February 2010]<br />
Webb M and Mahmoud A. . Evidence-based advice to <strong>in</strong>form commission<strong>in</strong>g<br />
decision on “Interventions Not Normally Funded”. Cardiff: NPHS; 2007.<br />
West Sussex Primary Care Trust. Low Priority Procedures (LPPS) and Other<br />
Procedures with Restrictions (OPRS), West Sussex PCT, 2006.<br />
Wilde, M. Addendum to CISSU policy. CECPCT Supplementary policy for the<br />
commission<strong>in</strong>g of procedures and treatments that are not covered through the<br />
normal contract<strong>in</strong>g process (<strong>Local</strong> addendum to Prior Approval Policy), Central<br />
and East Cheshire PCT, 2009<br />
APPENDIX 2<br />
BCULHB Draft IPC Procedure 58 18th February<br />
2010
The Referr<strong>in</strong>g Cl<strong>in</strong>ician must consider and complete all the questions set out<br />
below and provide accurate, legible and clear <strong>in</strong>formation on each – the form<br />
should then be submitted to the CPG lead officer for <strong>in</strong>dividual fund<strong>in</strong>g requests.<br />
The CPG encourages referr<strong>in</strong>g cl<strong>in</strong>icians to expand relevant sections where<br />
necessary to provide sufficient detail.<br />
This will enable the CPG IPC Panel to review the application for appropriateness<br />
<strong>in</strong> light of the benefits to the patient, equity of access for all patients and value for<br />
money and ensure adequate communication can take place with all those<br />
medical staff that have an <strong>in</strong>terest <strong>in</strong> the patient’s treatment.<br />
Name of Patient: ________________________ Date of Birth: _________________<br />
NHS Number: ________________________ Home Postcode:_______________<br />
Name of Referrer (Applicant): ___________________ Job Title: _______________<br />
Hospital or GP Practice: _________________________ Tel Contact: _______________<br />
of above Applicant<br />
Questions Comments / Explanation (must be completed)<br />
1. What is the specific treatment<br />
/ procedure or appo<strong>in</strong>tment that<br />
the patient is be<strong>in</strong>g referred for?<br />
2a. Is this a one-off treatment,<br />
or will ongo<strong>in</strong>g appo<strong>in</strong>tments /<br />
care / treatment be needed?<br />
2b. If this is ongo<strong>in</strong>g care,<br />
please give a clear <strong>in</strong>dication of<br />
the expected frequency and<br />
duration of care.<br />
3. What are your reasons for<br />
referr<strong>in</strong>g this patient? Please<br />
<strong>in</strong>clude a sufficient medical<br />
background, particularly<br />
where exceptionality may be a<br />
consideration.<br />
Please circle<br />
One-off<br />
Ongo<strong>in</strong>g<br />
BCULHB Draft IPC Procedure 59 18th February<br />
2010
Questions Comments / Explanation (must be completed)<br />
4. Does this application have<br />
the support of the appropriate<br />
BCUHB (or CPG) Cl<strong>in</strong>ical<br />
Governance body (e.g. letter or<br />
notes from the CPG/BCUHB<br />
D&T committee)<br />
5. What is the cl<strong>in</strong>ical evidence<br />
to support the use of this<br />
treatment (please identify the<br />
sources of evidence based<br />
research)<br />
6. At what stage <strong>in</strong><br />
NICE/AWMSG programmes is<br />
the requested treatment? Has it<br />
been appraised? If not, is it on<br />
their future agenda? Are there<br />
national guidel<strong>in</strong>es from<br />
professional bodies, Royal<br />
Colleges or other home<br />
countries comparable bodies.<br />
7. If the request contradicts<br />
NICE or AWMSG guidance,<br />
expla<strong>in</strong> why the patient is<br />
exceptional and this guidance<br />
does not apply (see Appendix 1)<br />
8. Please <strong>in</strong>dicate any<br />
treatments the patient has<br />
already had and other options<br />
for treatment available that have<br />
already been considered. If<br />
these have been discounted,<br />
please expla<strong>in</strong> why.<br />
9. Is the patient’s prognosis<br />
poor? If so, what <strong>in</strong>formation<br />
regard<strong>in</strong>g prognosis has been<br />
given to the patient?<br />
Please<br />
Circle<br />
Yes<br />
No<br />
BCULHB Draft IPC Procedure 60 18th February<br />
2010
Questions Comments / Explanation (must be completed)<br />
10. Is the proposed treatment<br />
licensed for this <strong>in</strong>dication? If<br />
necessary, please expla<strong>in</strong>.<br />
11. What is the approximate<br />
cost of the treatment (per<br />
procedure/ per appo<strong>in</strong>tment) –<br />
This should <strong>in</strong>clude the planned<br />
number of treatments or<br />
procedures with an <strong>in</strong>dicative<br />
total cost to the LHB.<br />
12. Which provider would you<br />
like the patient be referred to?<br />
Please justify your reason<strong>in</strong>g?<br />
Please <strong>in</strong>dicate if this is an NHS<br />
body or a private organisation.<br />
13. Please identify the cl<strong>in</strong>ician<br />
under whose care the patient<br />
would be and their contact<br />
details (i.e. name, address,<br />
telephone, safe haven fax email)<br />
14. Where relevant, has <strong>Health</strong><br />
Commission <strong>Wales</strong> already<br />
been approached to consider<br />
this request?<br />
Name of Patient’s GP:<br />
Practice:<br />
Name of Referr<strong>in</strong>g (Applicant) Cl<strong>in</strong>ician:<br />
Title:<br />
Address:<br />
BCULHB Draft IPC Procedure 61 18th February<br />
2010<br />
Please Circle<br />
NHS<br />
Private<br />
Name of GP / <strong>Local</strong> Specialist who referred patient<br />
directly to applicant (for secondary or tertiary<br />
service applications as appropriate):<br />
Hospital of <strong>Local</strong> Specialist:<br />
Signature:<br />
Date
Questions Comments / Explanation (must be completed)<br />
Identified CPG CPG support for application<br />
Yes No<br />
Signature<br />
Name Title<br />
BCULHB Draft IPC Procedure 62 18th February<br />
2010
APPENDIX 3<br />
BCULHB LHB Individual Patient Commission<strong>in</strong>g (IPC) Panel Checklist<br />
Patients Initial XX Date of Birth xx-xx-xx NHS no XXXXXXXXXX<br />
Initial referral<br />
Date received Name of referrer Comments<br />
Support<strong>in</strong>g Evidence<br />
Permanent North <strong>Wales</strong> Resident or<br />
resident of border PCT but<br />
registered with a GP <strong>in</strong> North <strong>Wales</strong><br />
Checked via Exeter<br />
Is this an NHS request?<br />
Fully Completed Application<br />
Proforma :<br />
Is this a prospective fund<strong>in</strong>g<br />
request?<br />
Does an LTA exist?<br />
Yes No Postcode:<br />
Yes No Comments where applicable:<br />
Yes No If <strong>in</strong>complete or no proforma received:<br />
Date request made for completed proforma:<br />
Yes No<br />
Date completed proforma received:<br />
Initial:<br />
Comments where applicable:<br />
Yes No Comments where applicable:<br />
Is this a <strong>Health</strong> Commission <strong>Wales</strong><br />
commissioned service?<br />
Yes No Comments where applicable:<br />
Initial Information logged onto Yes No Date: XX-XX-XX<br />
Database<br />
Initial:X.X.<br />
Case number assigned Yes No Case Number: XXX<br />
Initial:M.P.<br />
Advice sought and received from<br />
Public <strong>Health</strong> <strong>Wales</strong> or Medical<br />
Yes No Date and Outcome:<br />
Adviser<br />
Initial:<br />
Literature Review obta<strong>in</strong>ed and Yes No Date and Outcome:<br />
critiqued by Medical or Prescrib<strong>in</strong>g<br />
adviser<br />
Date of IPC Panel<br />
Initial:<br />
Panel Quorate? Yes No Comments where applicable:<br />
Medical History submitted &<br />
reviewed<br />
Yes No Comments where applicable:<br />
BCULHB Draft IPC Procedure 63 18th February<br />
2010
Has the application been approved<br />
by the CPG, Drugs and Theraputics<br />
Committee or through other Internal<br />
Cl<strong>in</strong>ical Governance processes?<br />
Yes No Comments where applicable:<br />
Details of prognosis Yes No Comments where applicable:<br />
Evidence submitted by referr<strong>in</strong>g<br />
Applicant<br />
Yes No Comments where applicable:<br />
Evidence considered by Panel Yes No Comments where applicable:<br />
Relevance to National Guidel<strong>in</strong>es Yes No Comments where applicable:<br />
Any further evidence submitted and<br />
considered, and by whom<br />
Case for Exceptionality submitted by<br />
Applicant<br />
Case for Exceptionality considered<br />
by Panel<br />
Other options for treatment<br />
submitted by<br />
Applicant<br />
Other options for treatment<br />
considered by Panel<br />
Yes No Comments where applicable<br />
Yes No Comments where applicable:<br />
Yes No Comments where applicable:<br />
Yes No Comments where applicable:<br />
Yes No Comments where applicable:<br />
Treatment supported by CPG Yes No Date and Outcome:<br />
Initial:<br />
Summary of Panel<br />
Recommendation<br />
Database updated Yes No Dates: XX-XX-XX<br />
Initial:X.X.<br />
Case completed and filed Yes No Dates: XX-XX-XX<br />
Initial:X.X<br />
BCULHB Draft IPC Procedure 64 18th February<br />
2010
The follow<strong>in</strong>g section should be completed by the approved BCU LHB accredited<br />
cl<strong>in</strong>ician (For rout<strong>in</strong>e fund<strong>in</strong>g decisions – this should be before relay<strong>in</strong>g the Panel decision<br />
to the referr<strong>in</strong>g cl<strong>in</strong>ician (Applicant). For emergency and urgent fund<strong>in</strong>g decisions, this may<br />
need to be after relay<strong>in</strong>g the Panel decision to referr<strong>in</strong>g cl<strong>in</strong>ician)<br />
Was this an Emergency / Urgent / Rout<strong>in</strong>e fund<strong>in</strong>g decision (please circle as appropriate)?<br />
Has a similar fund<strong>in</strong>g request been received by another IPC Panel with<strong>in</strong> BCU LHB area?<br />
Yes / No<br />
Further <strong>in</strong>formation is needed prior to reach<strong>in</strong>g a decision? Yes / No<br />
If yes, please comment<br />
…………………………………………………………………………………………………………<br />
…………………………………………………………………………………………………………<br />
Summary of BCU LHB accredited cl<strong>in</strong>ician’s view:<br />
In my op<strong>in</strong>ion, after evaluat<strong>in</strong>g the recommendations of the above Panel, I consider:<br />
1. This fund<strong>in</strong>g recommendation is congruent and consistent with other BCU LHB<br />
Panel decisions Yes / No<br />
2. If No, this fund<strong>in</strong>g recommendation, although <strong>in</strong>congruent or <strong>in</strong>consistent, is<br />
satisfactory due to the follow<strong>in</strong>g exceptional circumstances considered by the<br />
Panel:<br />
………………………………………………………………………………………………………<br />
………………………………………………………………………………………………………<br />
………………………………………………………………………………………………………<br />
………………………………………………………………………………………………………<br />
………………………………………………………………………………………………………<br />
………………………………………………………………………………………………………<br />
Signed………………………………………….. Date: ……………..<br />
Pr<strong>in</strong>t Name…………………………………………………………………<br />
Designation…………………………………………………………<br />
BCULHB Draft IPC Procedure 65 18th February<br />
2010
Date of IPC Panel<br />
For LHB Use Only<br />
Panel Recommendation on<br />
Application<br />
Level of Fund<strong>in</strong>g approved (if<br />
recommended)<br />
Authorisation Number (if Approved)<br />
Name of Authorised Director<br />
Signature of Authorised Director<br />
Reasons for Panel decision<br />
Comments / Explanation (must be completed)<br />
Approved / Decl<strong>in</strong>ed/ Deferred to Future Meet<strong>in</strong>g/Further<br />
Information Requested<br />
BCULHB Draft IPC Procedure 66 18th February<br />
2010