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Policy & procedures for managing individual funding requests

Responsible Directorate:

Commissioning

Responsible Director:

Carol McKenna

Date Approved:

Version 2: 9th December 2009

Committee:

PEC


Version Control

Document Title:

Policy & Procedures for Managing Individual Funding requests

Document number: Author:

Sarah Muckle

Contributors:

Judith Hooper, Carol McKenna, Vicki Dutchburn, Alison Bragg, Members of Exceptional Cases Committee and Appeals Panel,

Version:

0.20

Date of Production:

3 August 2009

Review date:

February 2010

Postholder responsible for revision:

Director of Commissioning

Primary Circulation List: Web address: Restrictions:

Standard for Better Health Map

Domain:

Clinical and Cost Effectiveness

Core Standard Reference:

D2

Performance Indicators:

1. All individual funding requests are considered in accordance with this policy and via the procedures outlined in it. 2. The PCT has a robust system in place to ensure consistency in decision making that takes into account legal and national guidance.

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Contents 1

Introduction 1.1 1.2

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Policy Statement Introduction

3 4

The Individual Funding Request Process 2.1 Initial contact – stage one 2.2 Screening – stage two 2.3 Outcomes of the screening process 2.4 Structure of the screening panel 2.5 Exceptional cases committee – stage three 2.6 Decision making process 2.7 Applications for consideration via the exceptional cases process 2.8 Decision for approval or non approval 2.9 Structure of the exceptional cases committee 2.10 Appeal committee – stage four 2.11 Decision making process 2.12 Decision for approval or non approval 2.13 Structure of the appeals committee 2.14 Precedence 2.15 Equality impact assessment 2.16 Training needs analysis 2.17 Monitoring compliance with this policy

8 9 11 12 12 13 14 14 15 15 15 15 15 16 17 17 17

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References

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Appendices 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 4.12

Appendix A: Clinical effectiveness hierarchy (A summary of the appraisal of evidence framework) Appendix B: Proforma for completion by referring clinician (Exceptional cases committee referral form) Appendix C: screening tool for individual funding requests Appendix D: Guidelines for considering restricted treatments Appendix E: Examples of standard letters Appendix F: Proforma for consideration by the appeals committee Appendix G: Flow chart illustrating the exceptional cases process Appendix H: Referral form for individuals with mental health issues or learning disabilities Appendix I: Process for considering Mental Health and Learning Disabilities related referrals Appendix J: Equality impact assessment tool Appendix K: Key stakeholders consulted/involved in the development of the policy Appendix L: Membership of the Committees involved in the Individual Funding Requests process

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20 24 26 37 68 72 74 75 76 77 78

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Policy Statement NHS Kirklees will have a systematic and planned approach to considering all individual funding requests that will take into account national, regional and local guidance to support decision making. This will ensure decisions are consistent and based on the best available evidence and enable the most appropriate care to be delivered within the context of individual clinical need.

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Introduction This policy outlines Kirklees process for managing individual funding requests. The vast majority of health care commissioned by the PCT is covered by NHS Service Level Agreements or other Contracts. However, there are a small number of requests for treatment by individual patients each year not covered by either of these. Purpose of this policy Guidelines were issued from the NHS Confederation in June 2008 that required Primary Care Trusts to consider how it: Manages Individual Funding Requests Considers the legal aspects of priority setting Manages the introduction of new treatments The process for managing new treatments will not be considered as part of this policy because it is a separate process within the PCT but will aim to provide a robust process of decision making by which all individual funding requests can be considered. Legal context A PCT has a duty: To allocate healthcare resources, utilising a consistent framework for decision making. To promote and provide a comprehensive healthcare service within its allocations and consider how this is best done. To be aware of differences in neighbouring trusts and be able to justify them if necessary (NHS Confederation, 2008a)

The PCT needs to be satisfied that any decision follows the process described in this policy and in doing so ensure requests are considered on their own merits. The courts have established that a PCT is not under an absolute obligation to provide every treatment that a patient demands, although they must be able to clearly demonstrate why a treatment has been refused (NHS Confederation, 2008a). A PCT can develop a policy which prioritises treatment to take account of the resources available to it and the competing demands on those resources. Patients with rare or unusual medical conditions have as much right to care as anyone else and have the right to have their requests considered properly, on their own merits and against the PCT‟s policy in each individual case. The need for priority setting to be central to PCT corporate governance in relation to individual funding requests and commissioning decisions cannot be underestimated because the potential for Judicial Review is increasing. Judicial Review is the process by which the lawfulness of decision making can be challenged and can occur as a result of major service change or refusal to fund treatments for individual patients. There are grounds for a review if: Decisions may be unlawful – acting outside statutory power (e.g. Not following direction of Secretary of State) Decisions may be irrational – considering irrelevant/excluding relevant factors Decisions are procedurally improper – e.g. failure to comply with PCT policy or the PCT policy itself being unlawful or irrational (NHS Confederation, 2008a)

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Commissioning principles PCT‟s are required to provide health care for their population and in doing so have to take account of the resources available, usually a fixed budget from central government to commission health care and services. The PCT‟s commissioning principles are used to make commissioning decisions in a consistent, fair and transparent way, given that funds are not endless and choices inevitably need to be made. The criteria for commissioning treatments are: Clinical needs – Consideration should be given to understanding the need and whether we are likely to achieve the greatest possible health outcome for the patient. Health care interventions which produce the greatest benefit in terms of clinical improvement and/or improvements in quality of life should be prioritised. Lawful – as previously discussed at the beginning of this policy as part of the legal responsibilities of the PCT. In addition, as part of this process a Clinician makes a request on behalf of the patient and therefore must be aware of the need to obtain informed consent for the referral as well as ensuring the patient is aware of both the potential benefits and risks of any treatment being requested. Clinically effective – commissioning decisions should be based on evidence of effectiveness wherever possible. For example, this could come from sources such as NICE, Cochrane reviews, meta-analysis or randomised control trials (See Appendix A for the Clinical Effectiveness Hierarchy). Cost-effective – given limited resources the trust must receive optimum value from available resources and recognises that QuALY (Quality Adjusted Life Years) would help judge this, with NICE using a maximum value of £30,000 per QuALY. However it is important to note that cost alone will not be a reason for refusing an individual funding request. Equitable – in this context equity means that if an individual funding request is agreed for a new treatment/drug trial then it could lead to service development which could benefit the wider population. In addition, once a precedent has been set, it is likely that future requests for the same treatment would also qualify for funding, subject to the clinical presentation of the patient. Accessible – while accessibility implies utilisation of local services the PCT also needs to take into account patient choice. The PCT would expect referrals to be made to NHS services wherever possible but a choice list will be provided to highlight where the PCT will fund treatment outside the local NHS if available and where requested by the patient. Good quality of care and patient experience - decisions should be based on the potential to deliver good quality and safe care, improve health outcomes and enhance patient experiences. Individual funding requests should be agreed if it meets this criteria and will achieve or has the potential to achieve against explicit measures of quality, including: Patient feedback through local and national surveys, PALS, complaints Local and national standards, targets and quality indicators (Dr Judith Hooper, PEC Paper, Nov. 07)

Associated Policies and Procedures This Policy and the procedures outlined within it do not relate to any other existing NHS Kirklees policies.

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Aims and Objectives NHS Kirklees aims to have a systematic and consistent approach to the management of individual funding requests. This will be achieved by the following objectives: To be compliant with legal guidelines issued by the NHS Confederation To have systems in place that enable a consistent approach to decision making within appropriate timescales To ensure decisions made are based on the best available evidence at the time of consideration Scope of the Policy This policy and the procedures within it must be followed by all NHS Kirklees employees receiving an individual funding request or those involved in the process of considering individual funding requests. Clinicians making an individual funding request on behalf of their patient are expected to adhere to the procedures outlined in this policy. Advice and support is available from NHS Kirklees contracting team. Accountability and responsibilities Lead Director The lead Director with overall responsibility for this process is the Director of Commissioning. Responsibilities Responsibility for making decisions regarding individual funding requests on behalf of NHS Kirklees is delegated to those involved in the processes outlined in this policy. Committee Responsibility Ultimate responsibility for this process lies with the Governance Committee. The annual report will be made available to the Governance Committee to enable them to: Ensure the systems in place are sufficient to meet patients needs Ensure that decisions made throughout the process are consistent and appropriate Ensure positive health outcomes are being achieved as a result of the decisions made. Any potential problems identified in the structure or process of decision making will result in a review of this policy.

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Structure of reporting to the Board

Board

Governance Committee

Individual Funding Requests Management Group

Responsibility for Policy Review It will be the responsibility of the Individual Funding Requests Management Group to update this policy and the criteria used to inform decision making annually or in response to new local, regional and National guidelines as they become available. The Individual Funding Requests Management Group will consist of the members of the screening panel, Directors and Assistant Directors involved in the exceptional cases and appeals processes and the Lead Director with overall responsibility for this process, the Director of Commissioning.

Changes to other policies within the PCT may occur as part of this process. This could occur following the introduction of new National Guidelines or where a significant number of people are applying for funding for the same treatment or intervention, leading to a review of routinely commissioned treatments/services. When a policy decision needs to be made recommendations will go to: Senior Management Team – for decisions involving policy changes that impact on the management of the PCT Professional Executive Committee – for clinical decisions Any policy decisions made by either of these groups should then be reviewed by the Individual Funding Requests Management Group to determine how this impacts on the Individual Funding Requests Policy.

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The Individual Funding Request Process An Individual Funding Request is a request to a PCT to fund healthcare for an individual who falls outside the range of services and treatments that the PCT has agreed to commission (NHS Confederation, 2008b). This process should be both thorough and comprehensive taking into account the legal issues and commissioning principles outlined above. The process of decision making in all cases should therefore be: Consistent – in line with agreed policy Concise - often requests for funding are related to care which is required relatively urgently, but not so concise that key issues are marginalised Transparent and explicable Defensible – based on sound evidence from national or legal guidance

There will be four stages for considering requests: 1. 2. 3. 4.

Initial contact by the referring Clinician Initial consideration and screening of requests Consideration by Exceptional Cases Committee If necessary then patients can appeal via the referring Clinician

Individual funding requests may be initiated by the General Practitioner, Consultant or Dentist. It is the responsibility of the individual seeking funding in conjunction with the referring Clinician to ensure that all relevant information is forwarded to the PCT. This should include: 1. An outline of the patient‟s problem and the circumstances of the case, including any previous treatment; 2. A clear statement of the referral/treatment plan proposed 3. Consideration of whether the patient‟s needs could be met within existing pathways 4. If the care could be provided within existing pathways, a statement of why an alternative referral, which would not be offered to others with a similar clinical need, is a priority in this case; 5. If the care is not routinely funded by the PCT through existing care pathways, evidence to show why this patient is exceptional A referral form is should be completed by the referring Clinician in all cases (See Appendix B) in order to ensure all the above information is received. The only exception to this is when alternative proforma is available from individual trusts requesting high cost drugs for individual patients. If a referral form is not completed your referral will not be considered until NHS Kirklees receives the information it requires to enable a decision to be made. If not included with the request the PCT will seek clinical support for the request from the referring Clinician or others (e.g. GP, Consultant, and Dentist). Irrespective of the source of the request for treatment, only requests from the referring Clinician can be considered.

Individual Funding Requests Coordinator The role of the Individual Funding Requests Coordinator is an administrative role tasked with coordinating the individual funding requests process. Any queries to the details of a specific case at any stage of the process should be done so in writing via the GP or referring

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Clinician. This will enable accurate records of each case to be maintained and enquiries to be answered by the most appropriate person. The option to contact the Individual Funding Requests Coordinator is available to either the patient or referring Clinician if clarification is required regarding the individual funding requests process. Initial Contact – Stage One All requests for funding should be referred in writing in the first instance to the Commissioning Directorate (Contracts Team) or other member of staff to whom this function has been delegated (usually the Individual Funding Requests Coordinator). On receiving a request the Coordinator will: Enter the request onto a secure database Assign a unique Individual Funding Request (IFR) number Create a file within which to keep all correspondence and information relating to the request Log all correspondence onto the secure database The Individual Funding Requests Coordinator should collate the information supplied for each case and ensure it is passed on to the screening panel to enable them to consider each case and complete the screening matrix (Appendix C) as comprehensively as possible. Screening – Stage Two Screening cases is recommended as good practice by the NHS Confederation (2008b). The role of screening is to review all applications in relation to current national, regional or local guidance and/or polices as well as identifying any previous precedents that have been set. At this stage patient identifiable information will be available to the screening panel because of their role in information gathering and coordination of the process. The screening panel will use a tool to assess each individual request, criteria includes for a specific intervention:Appropriateness, Comprehensiveness, Effectiveness including that of safety, Size of intended benefit (outcomes), Likely numbers of people in the PCT that may benefit from this intervention, Alternative interventions and consequences of not having intervention. The full screening matrix is attached (Appendix C). Individuals requesting funding are screened for: Treatment or drugs not covered by existing Service Level Agreements or are specifically identified as exceptions within the Service Level Agreement Treatment available locally but requested from another provider where additional cost will lead to uncertain extra clinical benefit Treatment or drugs that are not routinely commissioned Treatment or drugs that are new or experimental Complex or unusual cases The following guidance should also be taken into account when considering appropriateness of a request: High Cost Drugs: Individual funding requests for high cost drugs. On receiving a request for high cost drug treatment the screening panel will consider available evidence based reviews

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to inform the decision making process. The request will also be reviewed by a Medicines Management representative to provide key information that should be considered. A representative from Medicines Management will attend the screening panel to present any information and discuss these cases as required. Introduction of new drugs or treatments: Consideration of new drugs/treatments should be referred into established planning frameworks but a decision should be made as to whether an interim commissioning policy is needed to enable the Clinician/patient to access treatment until a decision is made by the Regional Specialist Commissioning Group. Restricted Treatments: Treatments not included in existing pathways are not routinely funded but policy statements on restricted treatments are available. Individual funding requests can be considered in relation to these restricted treatments to assess whether the request fits the criteria or if exceptional circumstances exist. A list of currently agreed restricted treatments is supplied in Appendix D. Rare Conditions: These patients are unlikely to have treatment options covered by NICE guidance or commissioning policies and therefore, in this case individual funding requests should be considered against the commissioning principles. Drug Trials: The PCT will not usually provide funding for individuals coming off drug trials unless prior agreement has been obtained prior to a patient commencing a trial. In accordance with the Medicines Act (2004) responsibility for an exit strategy from a trial lies with those conducting it (NHS Confederation, 2008b). Continuing Private Care: Funding for individuals to continue care purchased privately, where an individual has exhausted their own resources or chosen to terminate a private arrangement, will not routinely be funded by the PCT. Applications for funding can be considered via the ECC process in the usual way. Inheriting decisions from other PCT’s: Patients moving into the PCT area and registering with a GP in the PCT area, become the responsibility of the PCT and therefore decisions for treatment already agreed by the previous PCT would normally be upheld as long as it is consistent with the principles in this policy and the Department of Health publication “Establishing a Responsible Commissioner”. Retrospective Payment: Patients who have paid for private treatment and then ask for reimbursement of these costs from the PCT. The PCT would not support such applications because prior approval for funding should have been sought through the processes outlined in this policy. Co-payment: Patients who pay for some aspect of treatment while being treated in the Public Sector. The NHS Act (2006) does not allow for recovery of charges for healthcare and the Code of Conduct for Private Practice: Guidance for NHS Medical Staff (2003) states that patients wishing to become private patients cannot be treated as both a private and NHS patient during the same visit to an NHS Organisation. The government‟s current position is to rule out co-payment and it is recommended that PCT‟s follow this guidance because it would provide access to a treatment that the PCT was not making available to others (NHS Confederation, 2008b). Patient Safety: The PCT has a responsibility for patient‟s safety when being treated in healthcare settings. The Healthcare Commission governs the suitability of providers of NHS services and therefore patients should only be referred to providers registered with the Healthcare Commission.

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Outcomes from the Screening Process 1 There are 4 potential outcomes from the screening process: Inappropriate Where cases are inappropriate for consideration the reasons for the decision plus any actions to be taken shall be documented by the screening panel and the patient and referring Clinician informed within 5-10 working days of the screening panel meeting (examples of inappropriate cases include requests that are already part of a commissioned pathway or requests where there is not enough information to make a decision). Approved Individual funding requests can be approved as part of the screening process if the referring Clinician is requesting approval for treatment on the restricted treatments list where the patient already meets agreed criteria. The patient and referring Clinician will be informed within 5 working days of the screening panel meeting. Requests for high cost drugs can be approved by the screening panel if the request is supported by local, regional or national policy or guidance. If clear guidance is not available then the original research will have to be considered to support decision making. If a review of the evidence is unable to provide clear guidance then the request should be considered exceptional and referred to the Exceptional Cases Committee, supported by all the available evidence. In terms of rare conditions the same process of evidence review shall be followed as outlined for considering high cost drugs. As the Lead Responsible Officer and Chair of the screening panel the Senior Contracts Manager will take responsibility for signing off approved requests. Refused Individual funding requests can be refused as part of the screening process if the individual does not meet agreed criteria, there is no clear evidence supporting the treatment, or where the request does not clearly demonstrate exceptionality. In the event of refusal to fund, the referring Clinician will be advised of the reason for refusal and future submission will have to clearly address these issues before a request can be approved or referred to the Exceptional Cases Committee, depending on which is the most appropriate course of action. In cases where an individual wishes to appeal against a decision made by the screening panel cases can be referred on to the Exceptional Cases Committee for further discussion.

1 It should be noted that in severe financial difficulties the following has occurred in 2006 by Huddersfield PCT’s and thereafter by Kirklees PCT until early 2007: Moratorium: In circumstances of severe financial constraint consideration of Individual Funding Requests can be suspended by the PCT. It is lawful and fair to restrict treatments on the basis of cost in extreme circumstances. However it will still be necessary to screen requests and continue to support those that the ECC agree meet the following criteria: The condition is immediately life threatening That undue delay would result in a real and imminent risk of harm e.g. death, infirmity or handicap That the procedure needs to be carried out within a strict time frame as delay would result in it becoming ineffective

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Exceptional Exceptionality should be considered in the context of the PCT general policy for an intervention and specified indication. In general, the PCT must justify the grounds upon which it is choosing to fund treatment for a patient when the treatment is unavailable to others with the condition A patient may be considered exceptional to the general policy if: Patient is different to general population of patients who would normally be refused treatment There are good grounds to believe the patient is likely to gain significantly more benefit from the intervention than might be expected for the average patient with that particular condition. E.g. May not tolerate standard treatment options. (Dr K Smith, Yorkshire & Humber SCG)

In assessing exceptionality, the PCT will not consider social, demographic or employment circumstances. All of these cases would be referred by the screening panel on to the Exceptional Cases Committee for consideration. In addition to the above: The screening panel may also refer a request to the Exceptional Cases Committee if they feel unable to make a decision and require a wider discussion. Urgent or Emergency cases It is recognised that there may be occasions when the screening panel receive cases for consideration that need a decision urgently. Given that there would be difficulties in convening the Exceptional Cases Committee at short notice in cases of extreme emergency (for example, someoneâ€&#x;s life is dependant on a decision being made) the screening panel will pass on its recommendations to the Executive Director in Public Health or the Executive Director with responsibility for Clinical Governance for a decision. A copy of standard letters for communication is supplied in Appendix E. Both the patient and referring Clinician will be notified of the decision to refer the case to the Exceptional Cases Committee within 5 working days of the screening panel meeting.

Structure of the Screening Panel The Screening Panel will consist of: Senior Contracts Manager (Chair) Public Health Clinician Individual Funding Requests Coordinator Medicines Management representative (for High Cost Drug Requests Only) In addition to the above there will be a separate screening panel following the same processes to consider individual funding requests relating to individuals with mental health problems and learning disabilities (See Appendix F for the referral form into this process for individuals with mental health problems or learning disabilities and Appendix G for the process referrals will follow). This screening panel will consist of: Assistant Director for Mental Health (Chair)

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General Manager for Mental Health Services Lead Nurse for Mental Health and Learning Disabilities specialist care team This is the core membership of the screening panel and if for any reason a member of the panel cannot attend then an appropriate replacement should attend the meetings and the panel will meet on a weekly basis.

Exceptional Cases Committee – Stage Three The Exceptional Cases Committee has delegated authority from the PCT Board to make decisions in respect of funding for individual cases but not to make policy decisions (reference Board approval when happens). The Exceptional Cases Committee meets once a month and will see a maximum of 30 cases in total in chronological order at each meeting. Copies of each file should be made for each Committee member. Files will not be anonymised because all members of the panel are bound by confidentiality as employees of NHS Kirklees. If any applicants are known to a committee member then that member will declare an interest, leave the meeting and therefore will not be part of the decision making process. The Individual Funding Requests Coordinator will produce a summary of the requests to assist the Committee and provide the completed screening matrix (Appendix C). The Exceptional Cases Committee will consider all cases referred as a result of the screening process. In reaching a decision the Committee will apply the PCTâ€&#x;s criteria as set out below. Decision making process It is important for the process to be: Transparent and explicable Defensible, for example, based on a clear process and sound evidence

In making a decision the Committee will consider all available clinical history, examine the evidence base where necessary. The Committee will: Review each patient request on an individual basis. Take into account relevant factors which are unique to the patient, e.g. current health status and existing co-morbidities Consider if the treatment is necessary and appropriate in relation to individual clinical need, with expected benefits outweighing any risks, and whether there are any exceptional needs or circumstances Consider the evidence base for safety and efficacy and if the request is drug related, its licensed indication Consider if the treatment is clinically and cost effective with equity of access and provision across the PCT, utilizing clinical information (provided by patientâ€&#x;s GP,

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Consultant or other appropriate clinical staff) and evidence base (regarding clinical and cost effectiveness of the intervention). Consider consistency with agreed guidance whether PCT, regional or national that may be available Consider other alternative options available for the patient including whether the request can be met by local or alternative providers or whether they are inappropriate for that individual. Consider if this establishes precedent or whether there is an existing precedent The panel will use the following sources of information to make the decision as to whether the case referred is an exception: o o o

Information provided by the patient‟s GP/referring Clinician Clinical effectiveness of the intervention requested Evidence that all alternative clinical strategies have been exhausted, e.g. conservative and primary care management of the patient‟s condition. (North Yorkshire & York PCT, 2008)

Applications for consideration via the Exceptional Cases process In instances where the matter is to proceed to the Exceptional Cases Committee, the Individual Funding Requests Coordinator will: Write to the referring Clinician within 5 working days confirming that the request has been received and requesting further information if required. This letter will also inform them of date of next Exceptional Cases Committee. Write to other health professionals with clinical involvement in the patient‟s care for clarification of the patient‟s needs, if required and/or appropriate. Decision for approval or non approval Whether the request for funding is approved or not the patient, the referring Clinician and the patients GP (Where they are not the referring Clinician) will be informed in writing of the Committee‟s decision within 5 working days of the Exceptional Cases Committee meeting. Where the request was refused the Committee will set out their decision and the reasons for it both to the patient and the referring Clinician. If the patient does not accept the outcome they can appeal via the Appeals Committee. Structure of the Exceptional Cases Committee Full membership of the Exceptional Cases Committee is supplied in Appendix H and it is the expectation that all of these people or their deputies will attend every Committee meeting. However there may be exceptional circumstances where on occasion the Committee is required to carry out its function on a minimum membership. In such circumstances the Committee is quorate with the presence of the following: Director (Chair) Non-Executive Director PEC Clinician A nominated Assistant Director or Senior Manager from Commissioning

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No ECC member should be a person who is on either Screening Panel Evidence to support decision making will be provided by the Public Health Clinician on behalf of the screening panel and where a decision needs to be made regarding an individual with mental illness a member of that screening panel will attend to present that case to the Committee. These people will not be members of the Committee and will not participate in the decision making process. Only those identified as members of the Committee (See Appendix H) will have the right to make decisions as part of the exceptional cases process. The Committee will be chaired by the Executive Director or their deputy. The Chair will be responsible for checking that the decisions made are accurately recorded and for signing any letters sent to patients and Clinicians reflecting those decisions. In case of disagreement, the Chair has the casting vote if necessary.

Appeal Committee – Stage Four Individuals wishing to appeal against a decision made by the Exceptional Cases Committee must notify the PCT of their intention, in writing, within 40 working days of the date of the initial decision via their GP or initial referring Clinician. The Individual Funding Requests Coordinator will send a letter reminding patients and Clinicians of the approaching deadline for appeal at the mid point of 20 working days post the Exceptional Cases Committee meeting. If the Clinician does not lodge an appeal within the allocated timescale the case will be closed and any further correspondence would start the process again. Decision making process The purpose of an appeal is to consider procedural irregularities or if it is clear that the Exceptional Cases Committee failed to take into consideration relevant information or took into consideration irrelevant information. Therefore, in making their decision the Appeals Committee will consider whether: a) The Exceptional Cases Committee was quorate b) The decision was consistent with policies and procedures including the Individual Funding Request/Exceptional Cases Committee process c) The decision made was correct based on the information supplied These key questions form the basis for the proforma followed by the Appeals Committee to ensure consistency of approach to each case (supplied as appendix I). If the patientâ€&#x;s condition changes or new information comes to light, then this will be referred back to the original Exceptional Cases Committee that made the first decision so that they can review it. An appeal is only to consider procedural irregularities. This is supported by guidelines from the NHS Confederation (2008b). Decision for approval or non approval The Individual Funding Requests Coordinator will write to the patient, referring Clinician and GP (where this is not the referring Clinician) within 5 working days with the Committeeâ€&#x;s decision and their reasons. The Appeal Committee will have the responsibility for making the definitive decision on whether the PCT should approve the treatment being requested. A

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failure in the process of handling an individual funding request does not necessarily mean that the decision that was made was incorrect. If an appeal results in the reversal of the original decision then the Exceptional Cases Committee will be formally notified of the reasons this decision was made. Patients who remain dissatisfied with the Appeal Committee decision will be given the information on potential courses of action as part of the letter detailing the Appeals Committee decision. Structure of the Appeals Committee Full membership of the Appeals Committee is supplied in Appendix H and it is the expectation that all of these people or their deputies will attend every Committee meeting. However there may be exceptional circumstances where on occasion the Committee is required to carry out its function on a minimum membership. In such circumstances the Appeals Committee is quorate with the presence of the following Executive Director (Chair) Non-Executive Director PEC Clinician To support decision making cases will be presented to the panel by a Public Health Clinician on behalf of the screening panel and where a decision needs to be made regarding an individual with mental illness a member of that screening panel will attend to present that case to the Committee. These people will not be a member of the Committee and will not participate in the decision making process. Only those identified as members of the Committee (See Appendix H) will have the right to make decisions as part of the Appeals process. The Committee will be chaired by the Executive Director and the Chair will be responsible for checking that the decisions made are accurately recorded and for signing any letters sent to patients and Clinicians reflecting those decisions. In case of disagreement, the Chair has the casting vote if necessary. A Flow Chart representing the complete Exceptional Cases process is provided in Appendix J. Precedence At any point in the decision making process of the Exceptional Cases Committee or the Appeals Committee a precedent could be set. This means that any decision made can be used to inform future decisions for similar requests. If previous decisions are not taken into account this could form the basis for legally challenging the PCT and the decision made on an individual funding request. Given the significance of setting precedence and its potential impact on future decisions all precedents set will be recorded on a secure database by the Individual Funding Requests Coordinator. However a decision to allow or refuse funding will not be absolutely binding on the PCT but where the PCT departs from a previous decision, clear evidence must be available to justify and support this departure (Examples of this might include a patient presenting with slightly different symptoms, or someone who due to age / weight / sex / other medication might not respond to treatment in the same way).

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Where individual funding requests are to be referred to the Exceptional Cases Committee the Screening Panel will review all precedents and make any relevant ones available to the Committee that may have an impact on the decision making process for that case. Treatment outside the European Economic Area (EEA) Requests for treatment outside the EEA will be considered in line with the Department of Health Patient Information Circular (14 March 2007), which states that “Patients do not have a right to have treatment outside the European Economic Area (EEA) paid for by their local PCT. Individuals requesting treatment outside the EEA should be aware that PCT’s are advised to consider the following criteria before approving treatment outside the EEA” Clinicians will need to demonstrate how their patient meets the following criteria as part of the individual funding request: The condition is of a serious nature. Suitable treatment is not available within the UK or the EEA. The treatment abroad is well established, not merely experimental. There is a probability of significant benefit to the patient.

Equality Impact Assessment All public bodies have a statutory duty under the Race Relation (Amendment) Act 2000 to “set out arrangements to assess and consult on how their policies and functions impact on race equality.” This obligation has been increased to include equality and human rights with regard to disability age and gender. The Trust aims to design and implement services, policies and measures that meet the diverse needs of our service, population and workforce, ensuring that none are placed at a disadvantage over others. In order to meet these requirements, a single equality impact assessment is used to assess all its policies/guidelines and practices. This policy guidance was found to be compliant with this philosophy after applying the Equality Impact Assessment Tool (see Appendix K).

Training Needs Analysis No specific training is required before this policy and the procedures outlined within it can be implemented.

Monitoring Compliance with this Policy The administration of this process continues beyond the stages described above in order to make informed commissioning decisions in the future. It will be the role of the Individual Funding Requests Coordinator to: Track all agreed requests to enable the PCT to collate information on patient flows and costs associated with individual funding requests.

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Contact referring Clinicians on a bi-annual basis for information as to the outcome of any treatment that was approved. The outcome will be logged on the secure database. Any information collected will be collated for an annual report each financial year that will include reporting number of individual requests, those approved and declined and the reasons for that decision at each stage of the process (screening, Exceptional Cases Committee and Appeals Committee), number that went to appeal as well as the tracking information and patient outcomes. In certain circumstances it may be necessary to trial a treatment or high cost drug prior to a decision being made. Where this is the case the outcome of the trial will be obtained prior to any decision about further treatment being made.

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References Department of Health (2003) A Code of Conduct for private practice: Guidance for NHS medical staff www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/DH_ 4100689 Hooper, J (2007) Functioning of the Exceptional Cases System. Report to the Kirklees PCT PEC: 28th November 2007 Smith, K (2008) Yorkshire and Humber Specialised Commissioning Group: Exceptionality. Friday 28th March 2008 The National Health Service Bill (2006) www.dh.gov.uk/en/publicationsandstatistics/publications/publicationslegislation/DH_4134387 The NHS Confederation (2008a) Priority Setting: Legal Considerations. www.nhsconfed.org/publications The NHS Confederation (2008b) Priority Setting: Managing individual funding requests. www.nhsconfed.org/publications North Yorkshire and York PCT. High Cost Healthcare Commissioning Policy. November2007 The Stationary Office (2004) 2004: The Medicines for Human use (Clinical Trials) Regulations. www.opsi.gov.uk/si/si2004/20041031.htm

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Appendices Appendix A: Clinical Effectiveness Hierarchy A Summary of the Appraisal of Evidence Framework

Reviewsâ€&#x; include the following studies as defined by the Health Development Agency (HDA website 2003): Evidence maps

Are there published reviews that answer the question?

Literature reviews Meta-analysis Research summaries Reviews

Experimental

No

Synthesis

Descriptive

Systematic reviews

Yes

Partly

Evaluation of

Systematic review of effectiveness guidelines

Is there another type of study is the most relevant for answering your question?

Appraise the review against CASP criteria. Is the review ok?

No Yes

No

Yes Appraise the study/studies against the CASP criteria Check for evidence published since the review Look for further strengths of evidence and review

Synthesise the recommendations

20


Appendix B: Proforma for completion by referring Clinician

EXCEPTIONAL CASES COMMITTEE (ECC) Referral Form Please use this proforma as your MASTER COPY!!! Patient‟s Name:

DOB:

NHS No:

Patient‟s Address:

DETAILS OF REQUEST AND SUPPORTING INFORMATION Please ensure that all relevant information is included in this form or is attached to ensure that requests are processed in a timely manner

21


Clinical information: (Please include patientâ€&#x;s current BMI, if relevant to request)

Options tried:

22


Evidence base to support request:

Evidence as to why this patient is an exception:

23


What outcomes are requested?

Costs (if known):

Signature, position & address of referring clinician:

Print Name:

Details of where to send: Claire Inwood

ECC Administrator NHS Kirklees, Broad Lea House, Bradley Business Park, Dyson Wood Way, Huddersfield, HD2 1GQ Telephone: 01484 464142 Fax: 01484 464577 (safe haven)

24


Appendix C - Screening tool for Individual Funding Requests FUNDING REQUEST ASSESSMENT MATRIX Criteria * Appropriateness

Estimated Impact

Notes Is this an exceptional case: Significantly different to reference population Likely to gain more benefit than average patient with that particular condition

* Comprehensiveness

Is there enough information supplied by the referring Clinician

* Effectiveness of impact and safety?

Evidence of effectiveness from National/Legal ? regional?/Local Guidance

Absolute cost and evidence of costeffectiveness

Absolute costs – estimates for a full year plus follow up Cost-effectiveness – Cost per QALY

* Size of intended benefit (Outcomes)

Details of how Clinician intends to assess outcomes if exceptional

Likely numbers of people in the PCT that may benefit from this intervention

Less than 3/3-10/More than 10 Horizon scanning for PCT to identify potential future need and therefore potential policy change

* Alternative interventions

Is there a viable alternative through commissioned pathways Have all alternatives been considered first

* Consequence of not having intervention

Potentially life threatening/serious/not serious Try to assess consequences of not having intervention (eg mobility, quality of life, etc)

Clinical Trials

Does the request comply with the criteria set out in the SCG Framework for “funding the continuance of treatment when clinical trails end”

25


Out come of Screening Panel Approved –

Deferred –

Declined -

Onward to ECC -

Action from Screening Panel

Signatures:

Public Health Specialist

Senior Contracts Manager

Head of Medicines Management

Individual Funding Requests Co-ordinator

Notes: This tool is intended to assist the information gathering process necessary to screen cases and ensure appropriateness of referral to the assessment panel. Normally this would be compiled by a Public Health Specialist A formal record of information gathered should be kept in order to ensure an auditable process of how decisions were made Complete the matrix as fully as possible, however it is recognised that it may not be possible to populate each cell for every case. Areas marked with a * are considered essential information

26


Appendix D: KIRKLEES PCT Guidelines for considering Restricted Treatments December 2009

The function of the Exceptional Cases Committee is:  

To assess all cases for NHS funding of specific types of treatment which are not routinely funded, criteria for which is listed below To consider cases which are exceptional to the NHS criteria for treatment.

The following are the types of treatment that shall be considered by the ECC. If in doubt then the referring clinician should refer to the ECC for advice. Where national, regional or local PCT criteria are available, they are set out in respect of each treatment 1

Breast reduction (female) Also known as surgery for breast hypertrophy or reduction mammoplasty. The intention of this exception is to provide funding where there are genuine issues with chronic neck or back pain related directly to breast size that cannot be dealt with effectively without surgical reduction of the breasts. The national criteria are: 1 The patient is suffering from neck ache, back ache (which should be present most of the time) and/or intertrigo. The patient wears a professionally fitted bra which has not relieved the symptoms. The patient has a body mass index (BMI) of less than 30 kg/m2.

Upper limit of normal BMI is 25 kg/m2. Patients seeking breast reduction have physical restrictions on their ability to exercise and additional weight in breast tissue (sometimes 3-4kg). Major complications for surgery in general and specifically related to breast reduction surgery have been shown to be greater if the BMI exceeds 30. In addition to the National Criteria we would also require: The patient has had a physiotherapy assessment carried out within 6 months of the request being made. The report must be sent with the request and must clearly give an opinion as to the cause of the applicant‟s pain. No request for funding can be considered without a recent physiotherapy report. BMI to have been measured within 2 months of the request being submitted The patient is aged 18 years or over, to allow for the completion of normal development

27


The PCT’s have also: approved:

Breast reduction where there is significant breast asymmetry (a difference of at least 2 cup sizes. The patient has had a physiotherapy assessment to exclude other causes of back ache.

declined:

2

Requests made for cosmetic/aesthetic reasons or for psychological benefit without associated clinical need.

Breast reduction (male) The national criteria are: 1 Patients must be post-pubertal and of normal BMI (<=25 Kg/m2). Appropriate screening for endocrinological and drug-related causes should also take place. In addition to the National Criteria we would also require: BMI to have been measured within 2 months of the request being submitted

3

Breast enlargement Breast enlargement which is part of reconstructive surgery after trauma or previous mastectomy or other excisional breast surgery does not go through the ECC as it is part of the treatment pathway for those conditions. The national criteria are: 1 Breast enlargement is only performed by the NHS on an exceptional basis and is not carried out for “small” but normal breast or for breast tissue involution (including post partum changes). Exceptions are made for women with an absence of breast tissue unilaterally or bilaterally, or in women with a significant degree of asymmetry of breast shape and/or volume. Such situations may arise as a result of: Previous mastectomy or other excisional breast surgery. Trauma to the breast during or after development. Congenital amastia (total failure of breast development). Endocrine abnormalities. Developmental asymmetry (locally defined as at least two cup sizes in difference). Gender reassignment – where requests for breast enlargement occur following gender reassignment surgery the same national criteria outlined above will be used to inform decision making. Additional local criteria: In relation to any requests for breast enlargement the Clinician must: Ensure the patient is aged 18 years or over, to allow for the completion of normal development

28


The PCT’s have also: declined:

Requests made for cosmetic / aesthetic reasons. Requests made for psychological benefit without associated clinical need.

4

Revision of Breast enlargement National criteria are: 1 Revisional surgery will only be considered if the NHS commissioned the original surgery. It is important that patients understand that they may not automatically be entitled to replacement implants in the future if they do not meet the criteria for augmentation at that time. If revisional surgery is being carried out for implant failure, the decision to replace the implant (s) rather than simply remove them should be based upon the clinical need for replacement and whether the patient meets the policy for augmentation at the time of revision.

5

Mastopexy (breast tightening) National Criteria are: 1 This is included as part of the treatment of breast asymmetry and reduction but not for purely cosmetic/aesthetic purposes such as post-lactational ptosis.

6

Correction of inverted nipples National criteria are: 1 Nipple inversion may occur as a result of an underlying breast malignancy and it is essential that this be excluded. The criteria are: Surgical correction of nipple inversion should only be available for functional reasons in a post-pubertal woman and if the inversion has not been corrected by correct use of a non-invasion suction device.

The PCT’s have also: declined:

Requests made for cosmetic / aesthetic reasons. Requests made for psychological benefit without clinical need

7

Abdominoplasty (“Tummy Tuck”)

29


National criteria are: 1 Abdominoplasty and apronectomy may be offered to the following groups of patients who should have achieved a stable BMI (stable is defined as within the acceptable range for at least 2 years) between 18 and 27 Kg/m2 and be suffering from severe functional problems: Those with complex scarring following trauma or previous abdominal surgery. Those who have undergone treatment for morbid obesity and have excessive skin folds Previously obese patients who have achieved significant weight loss and have maintained their weight loss for at least two years. Where it is required as part of abdominal hernia correction or other abdominal wall surgery. In addition to the National Criteria we would also require: BMI to have been measured within 2 months of the request being submitted Severe functional problems include: Recurrent intertrigo beneath the skin fold. Experiencing severe difficulties with daily living, i.e., ambulatory restrictions. Where previous post-trauma or surgical scarring (usually midline vertical or multiple) leads to very poor appearance and carries a risk of infection. Problems associated with poorly fitting stoma bags

The PCTâ&#x20AC;&#x2122;s have also: declined:

Requests made for cosmetic / aesthetic reasons, including stretch marks. Requests made for psychological benefit without clinical need

8

Body contouring procedures e.g., buttock lift, thigh lift, arm lift (brachioplasty). National criteria are: 1 These procedures will only be commissioned in exceptional circumstances and therefore all cases must be referred to the ECC. This is because functional disturbance tends to be less so surgery is less likely to be indicated except for appearance: in which case it should not be available on the NHS.

9

Liposuction (surgery to remove fatty tissue) for cosmetic reasons.

30


National criteria are: 1 Liposuction may be useful for contouring areas of localised fat atrophy or pathological hypertrophy (e.g multiple lipomatosis, lipodystrophies). Liposuction is sometimes an adjunct to other surgical procedures. It will not be commissioned simply to correct the distribution of fat.

The PCT’s have also: approved:

when being used as an adjunct to other surgical procedures e.g. surgery for gynaecomastia. pathological reasons. To correct the distribution of fat / scarring caused by previous surgical intervention.

declined:

10

Removal of diet resistant fat for cosmetic / aesthetic reasons.

Prominent “Bat” ears National criterion is: 1 The patient must be under the age of 19 years at the time of referral. Prominent ears may lead to significant psychosocial dysfunction for children and adolescents and impact on the education of young children as a result of teasing and truancy. The national service framework for children defines childhood as ending at 19 years. Some patients are only able to seek correction once they are in control of their own health care decisions. Children under the age of 5 rarely experience teasing, and referral may reflect concerns expressed by the parents rather than the child.

The PCT’s have also: approved:

Requests where there is significant asymmetry. Requests where patients are over 19 but were under 19 at the time of referral (the referral may have been delayed in certain circumstances).

declined:

11

Requests made for cosmetic/aesthetic reasons or for psychological benefit when aged over 19.

Repair of external ear lobes (lobules) National criteria are: 1 This procedure is only available on the NHS for the repair of totally split ear lobes as a result of direct trauma.

31


12

Blepharoplasty (surgery for drooping or mis-shaped eyelid) National criteria are: 1 Surgery on the upper lid is considered to correct functional impairment (not purely for cosmetic reasons) as demonstrated by: Impairment of visual fields in the relaxed, non-compensated state. Clinical observation of poor eyelid function, discomfort, e.g., headache worsening towards end of day and/or evidence of chronic compensation through elevation of the brow. The PCT’s have also: approved:

when the condition results from diagnosed pathology

declined:

requests made for cosmetic/aesthetic reasons only

Surgery on the lower lid is available on the NHS for correction of ectropion or entropion or for the removal of lesions of the eyelid skin or lid margin i.e. that cause clinical problems.

The PCT’s have also: declined:

13

Where there is excessive skin on the lower lids causing „eyebags‟ but which doesn‟t affect function.

Rhinoplasty (surgery to improve the shape of the nose) National criteria are: 1 Problems caused by obstruction of the nasal airway Objective nasal deformity caused by trauma. Correction of complex congenital conditions (e.g. cleft lip and palate)

This is agreed for cases where there are functional problems. Correction of complex congenital conditions, (e.g. cleft lip and palate) which are part of the treatment pathway for those conditions do NOT need ECC approval. Other patients must be referred to the ECC. The PCT’s have also: declined:

14

Requests made for cosmetic / aesthetic reasons.

Facial procedures (face lifts and brow lifts (rhytidectomy))

32


National criteria are: 1 These procedures will be considered for treatment of: Congenital facial abnormalities. Facial palsy (congenital or acquired paralysis). As part of the treatment of specific conditions affecting the facial skin, e.g., cutis laxa, pseudoxanthoma elasticum, neurofibromatosis. To correct the consequences or trauma. To correct deformity following surgery. They will not be available to treat the natural processes of ageing or for cosmetic reasons.

15

Osseo-integrated implants (Surgical procedure to improve or repair missing facial bones or teeth).

Implantation may be agreed If the patient meets one or more of the following criteria. The patient has: A history of severe denture intolerance and/or severe bone loss. Congenitally absent teeth which cannot be effectively treated by orthodontic treatment and/or other restorative means. Suffered loss of facial bone, alveolar bone or teeth through an accident or disease.

16

Removal of tattoos Cases must be referred to the ECC. The national criteria are: 1 Where the tattoo is the result of trauma, inflicted against the patient‟s will (“rape tattoo”). Exceptions may also be made for tattoos inflicted under duress during adolescence or disturbed periods where it is considered that psychological rehabilitation break up of family units or prolonged unemployment could be avoided, given the treatment opportunity. (Only considered in very exceptional circumstances where the tattoo causes marked limitations of psychosocial functioning.) The PCT’s have also:

17

approved:

If the tattoos may hinder the patient‟s opportunity to gain work.

declined:

requests for patients who have tattoos which are easily concealed i.e. on their arms, legs etc.

Hair depilation (hair removal)

33


Cases must be referred to the ECC. National criteria are: 1 Hair depilation will be agreed on the NHS for patients who: Have undergone reconstructive surgery leading to abnormally located hair-bearing skin. Have a proven underlying endocrine disturbance resulting in hirsutism (e.g., polycystic ovary syndrome). are undergoing treatment for pilonidal sinuses to reduce recurrence. In addition to the National Criteria we would also require: Where laser treatment is requested for hair removal and the applicant meets the above criteria only 10 sessions will be approved at any one time. Following those 10 sessions the referring Clinician will be asked to write to NHS Kirklees with evidence of effectiveness before any further treatment can be approved.

18

Circumcision for religious reasons Cases must be referred to the ECC. These are only agreed for exceptional circumstances, for example, when an underlying medical condition means that routine surgery in the usual setting may be unsafe.

19

Reversal of sterilisation.

The local criterion is: This procedure is only available when children from existing or previous relationships have died through accidents or illness. The PCTâ&#x20AC;&#x2122;s have also: approved:

Cases when the patient was very young when the procedure was carried out and evidence from the referring clinician shows that they did not receive any counselling.

declined:

Patients in a new relationship who are not in contact with children from a previous relationship. Patients who claim that they were not told that the procedure was irreversible.

20

Correction of hair loss (alopecia) National criterion is: 1

34


This is available on NHS when it is a result of previous surgery or trauma including burns. 21

Correction of male pattern baldness National criterion is: 1 This is excluded from treatment by the NHS.

22

Hair transplantation National criterion is: 1 This will not be allowable on the NHS, regardless of gender, other than in exceptional cases, such as reconstruction of the eyebrow following cancer or trauma.

23

Skin and subcutaneous lesions (fatty lumps (lipomata)) National criteria are: 1

Lipomata of any size must be considered for treatment by the NHS in the following circumstances: The lipoma (-ta) is / are symptomatic. There is functional impairment. The lump is rapidly growing or abnormally located (e.g., sub-fascial, sub-muscular). 24

Other benign skin lesions National criteria are: 1 Clinically benign skin lesions must not be removed on purely cosmetic grounds. This will include, amongst other conditions, skin tags and seborrhoeic keratoses (warts). Patients with moderate to large lesions that cause actual facial disfigurement may benefit from surgical excision. The risks of scarring must be balanced against the appearance of the lesion. Epidermoid or pilar cysts (commonly known as â&#x20AC;&#x153;sebaceousâ&#x20AC;? cysts) are always benign but some may become infected or be symptomatic. Some may require surgical excision particularly if large or located on the face or on a site where they are subjected to trauma.

25

Skin hypo-pigmentation National criteria are: 1 The recommended NHS suitable treatment for hypo-pigmentation is cosmetic camouflage. Access to a qualified camouflage beautician must be available on the NHS for this and other skin conditions requiring camouflage.

35


26

Vascular skin lesions National criteria are: 1 NHS treatment is allowed for all vascular lesions except for small benign, acquired vascular lesions such as thread veins and spider naevi.

27

Rhinophima National criteria are: 1 The first-line treatment of this disfiguring condition of the nasal skin is medical. Severe cases or those that do not respond to medical treatment may be considered for surgery or laser treatment.

28

Skin “resurfacing” techniques National criteria are: 1 All resurfacing techniques, including laser, dermabrasion and chemical peels may be considered for post-traumatic scarring (including post-surgical) and severe acne scarring once the active disease is controlled.

29

Botulinum toxin National criteria are: 1 Botulinum toxin has many uses within the NHS. It is available for the treatment of pathological conditions by appropriate specialists. Botulinum toxin is not available for the treatment of facial ageing or excessive wrinkles.

30

Allergy treatments at a specialist allergy centre The local criterion is: The condition has been thoroughly assessed and standard treatment given by a GP or Clinician but the condition has not improved and is considered “resistant” to conventional treatment. This refers to requests for treatment at non-NHS units. Referrals will only be made to one of the 6 specialist allergy centres as per SCG guidance. The PCT’s have also: declined:

31

Requests for patients who haven‟t previously undergone conventional treatments and explored local options first.

In vitro fertilisation 2 The eligibility criteria currently operating across West Yorkshire are:

36


        

You have both been thoroughly investigated and no other treatment is considered appropriate The woman is aged between 23 and 39 years old at the start of the treatment. You and your partner are in a stable relationship and able to provide for the needs of a growing child (in keeping with Human Fertilisation and Embryology Authority guidance) Neither of you has been sterilised Neither of you has any living children from the current or previous relationships You must both be referred to the Assisted Conception Unit at Leeds Teaching Hospitals NHS Trust by a named consultant gynaecologist As a couple, you should have had no previous NHS-funded attempt. The woman‟s BMI should be within the range of 19-30 The couple must be willing to have anonymised data on outcome shared with commissioners

In addition to the National Criteria we would also require: BMI to have been measured within 2 months of the request being submitted 32

Surrogacy Local criteria are: In the absence of a clear legal and/or Department of Health position on the role and responsibilities of public bodies funding surrogacy, it is recommended that NHS Kirklees should not fund requests for surrogacy. There are also concerns over the ethics of surrogacy given the unknowns.

Many new medicines are launched within the NHS each year. Some of these are improvements to those already available. Others are completely new medicines which are reviewed by the PCT‟s. For certain medicines, the information on their effectiveness or safety is not considered sufficiently useful for them to be funded by the PCT‟s. These drugs are being continually reviewed by the PCT‟s and the policy may alter during the year. The process for decision making in relation to high cost or new medicines is outlined in full in the Kirklees Individual Funding Requests Policy. References 1. 2.

NHS Modernisation Agency. Information for Commissioners of Plastic Surgery: referral and guidelines in plastic surgery. 2005. NICE guidance no 11. In vitro fertilisation.

37


Appendix E: Examples of Standard letters Receipt of Referral Letter to referring Clinician

St Lukeâ&#x20AC;&#x;s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466000 Fax: 01484 466139 DATE Direct line:01484 466095 e-mail: ecc.administrator@kirkleespct.nhs.uk

IFR No: IFR *** (Quote IFR no. on all correspondence and invoices)

Dear

Re:

DOB:

Treatment requested:

Thank you for your referral to the Exceptional Cases Committee (ECC) dated (DD/mm/yyyy). Your patientâ&#x20AC;&#x;s case will be presented at the next available Screening Panel so that it can be assessed as to whether further information is needed, for this case to be considered via the Exceptional Cases Committee or if the case meets the criteria and will be approved. The Screening Panel will: Assess the information contained in the referral and will Approve the request if all set criteria are met.

38


Decline/Defer a request if inappropriate (i.e. not enough information is supplied/ there is an existing pathway.) Forward on to the Exceptional Cases Committee if exceptionality has been stated. I will write to you again in due course with regards to the decision of the Screening Panel. We are unable to discuss the details of individual cases by telephone but If you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Coordinator on the above number. Yours sincerely

Senior Contracts Manager

39


Receipt of Referral Letter to Patient

St Lukeâ&#x20AC;&#x;s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466000 Fax: 01484 466139 DATE Direct line:01484 466095 e-mail: ecc.administrator@kirkleespct.nhs.uk

IFR No: IFR *** (Quote IFR no. on all correspondence and invoices) Dear Re:

DOB:

Treatment requested: Thank you for your referral to the Exceptional Cases Committee (ECC) dated (DD/mm/yyyy). Your case will be presented at the next available Screening Panel, to be assessed as to whether further information is needed, for this case to be considered via the ECC or if the case meets the criteria and will be approved. I will write to you again in due course with regards to the decision of the Screening Panel. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Senior Contracts Manager

40


Screening Panel Approved â&#x20AC;&#x201C; Letter to referring Clinician

St Lukeâ&#x20AC;&#x;s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466000 Fax: 01484 466139 DATE Direct line:01484 466095 e-mail: ecc.administrator@kirkleespct.nhs.uk

IFR No: IFR *** (Quote IFR no. on all correspondence and invoices) Dear Re:

DOB:

Treatment requested: The Screening Panel met on (DATE) and discussed your request for funding for the above procedure. I am writing to inform you that the Screening Panel has approved this request. The evidence provided was sufficient for the panel to approve the request as your patient met with the criteria set by Kirklees Primary Care Trust. You may now make and NHS referral for this patient to a Care Quality Commission registered provider, please enclose a copy of this letter with your referral as confirmation that the PCT has agreed the funding. We are unable to discuss the details of individual cases by telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number Yours sincerely

Senior Contracts Manager

41


Screening Panel Approved â&#x20AC;&#x201C; Letter to Patient

St Lukeâ&#x20AC;&#x;s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466000 Fax: 01484 466139 DATE Direct line:01484 466095 e-mail: ecc.administrator@kirkleespct.nhs.uk

IFR No: IFR *** (Quote IFR no. on all correspondence)

Dear RE: REQUEST FOR The Screening Panel met on (DATE) and discussed your request for funding for the above procedure. I am writing to inform you that the Screening Panel has approved this request. The evidence provided from your referring clinician was sufficient for the panel to approve the request as you met with the criteria set by Kirklees Primary Care Trust. I have written to (CLINICIAN) who will now make the necessary arrangements to refer you. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Senior Contracts Manager

42


Screening Panel Deferred – Letter to referring Clinician

St Luke‟s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Direct line:01484 466095 Fax: 01484 466139 DATE e-mail: eccadminstrator@kirkleespct.nhs.uk

IFR No: IFR *** (Quote IFR no. on all correspondence)

Dear Re:

DOB:

Treatment requested: The Screening Panel met on (DATE) and discussed your request for funding for the above named to undergo (insert treatment). Unfortunately, the Screening Panel was unable to make an informed decision because of insufficient information with regards this patient‟s case and the requested treatment. The Screening Panel would like further information with regards to……. The case has therefore been deferred until you can provide the information requested above. If the information is not received within 40 working days of the date of this letter this case will be closed. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Senior Contracts Manager

43


Screening Panel Deferred â&#x20AC;&#x201C; Letter to Patient

St Lukeâ&#x20AC;&#x;s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466000 Fax: 01484 466139 DATE Direct line:01484 466095 e-mail: eccadministrator@kirkleespct.nhs.uk

IFR No: IFR *** (Quote ECC no. on all correspondence)

Dear Re: The Screening Panel met on (DATE) and discussed your request for funding for (insert treatment/procedure)

I am writing to inform you that the Screening Panel could not make a final decision until they had received some more information from your clinician. I have written to request this further information, required in order for your case to progress If this information is not received from your clinician with in 40 working days of the date of this letter, your case will be closed. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Senior Contracts Manager

44


Exceptional Cases Committee Declined – Letter to referring Clinician

St Luke‟s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466000 Fax: 01484 466139 DATE e-mail: ecc.administrator@kirkleespct.nhs.uk

IFR No: IFR*** (Quote IFR no. on all correspondence)

Dear

Re:

DOB:

Treatment requested: The Exceptional Cases Committee met on (DATE) and request for funding for the above named to undergo the above treatment.

discussed

your

I am writing to inform you that the committee has declined this request. The recorded rationale behind this decision is …………………. The patient has been informed of the decision and has been advised to discuss the rationale and the possibility of an appeal with you. If you decide to pursue an appeal, you will be required to supply evidence to support an appeal. This should be sent to the Individual Funding Requests Co-ordinator at the address above within 40 working days of the date of letter. The Appeals Committee will then investigate whether the decision made previously was correct and check that the appropriate guidelines were followed.

45


We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Sheila Dilks Executive Director of Patient Care and Professions

46


Exceptional Cases Committee Declined – Letter to Patient

St Luke‟s House Blackmoorfoot Road Crossland Moor Huddersfield HD4 5RH Tel: 01484 466095 Fax: 01484 466139 DATE e-mail: ecc.administrator@kirkleespct.nhs.uk

IFR No: IFR*** (Quote IFR no. on all correspondence) Dear Re: The Exceptional Cases Committee met on (DATE) and discussed your request for funding for (insert Treatment/procedure). I am writing to inform you that the committee has declined this request. The recorded rationale behind this decision is…………………………. Your referring clinician has also been informed of this decision. If you would like to discuss the rationale behind this decision, or you feel that you would like to pursue an appeal, you should contact your GP or referring clinician as soon as possible. If you wish to pursue an appeal your intention to do so should be made in writing by your referring clinician to the Individual Funding Requests Co-ordinator at the address above within 40 working days of the date on this letter. If this is not received within this time period this case will be closed. The appeals process will also require the support of your GP or referring clinician. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries about the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Sheila Dilks Executive Director of Patient Care and Professions

47


Exceptional Cases Committee Approved â&#x20AC;&#x201C; Letter to referring Clinician

St Lukeâ&#x20AC;&#x;s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466095 Fax: 01484 466139 DATE e-mail: ecc.administrator@kirkleespct.nhs.uk

IFR No: IFR*** (Quote IFR no. on all correspondence and invoices)

Dear Re:

DOB:

Treatment requested:

The Exceptional Cases Committee met on (DATE) and discussed your request for funding for the above named patient to undergo (insert Treatment/ Procedure). I am writing to inform you that the evidence provided was sufficient for the committee to approve this request. You may now make an NHS referral for this patient to a Care Quality Commission registered provider, please enclose a copy of this letter with your referral as confirmation that the PCT has agreed the funding. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Sheila Dilks Executive Director of Patient Care and Professions

48


Exceptional Cases Committee Approved â&#x20AC;&#x201C; Letter to Patient

St Lukeâ&#x20AC;&#x;s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466095 Fax: 01484 466139 DATE e-mail: ecc.administrator@kirkleespct.nhs.uk

IFR No: IFR*** (Quote IFR no. on all correspondence)

Dear Re: Request for The Exceptional Cases Committee met on (DATE) and discussed your request for funding for the above procedure

I am writing to inform you that the committee has approved this request. The evidence provided was sufficient for the committee to approve the request as an exceptional circumstance. I have written to your referring clinician who will now make the necessary arrangements to refer you. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Sheila Dilks Executive Director of Patient Care and Professions

49


Exceptional Cases Committee Deferred – Letter to referring Clinician

St Luke‟s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466095 Fax: 01484 466139 DATE e-mail: eccadminstrator@kirkleespct.nhs.uk

IFR No: IFR*** (Quote IFR no. on all correspondence)

Dear Re:

DOB:

Treatment requested: The Exceptional Cases Committee met on (DATE) and discussed your request for funding for the above named to undergo (insert treatment/procedure). Unfortunately, the committee was unable to make an informed decision due to insufficient information with regards this patient‟s case. The Exceptional Cases Committee would like further information with regards to……. The case has therefore been deferred until you can provide the information requested above. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Sheila Dilks Executive Director of Patient Care and Professions

50


Exceptional Cases Committee Deferred â&#x20AC;&#x201C; Letter to Patient

St Lukeâ&#x20AC;&#x;s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466095 Fax: 01484 466139 DATE e-mail: eccadministrator@kirkleespct.nhs.uk

IFR No: IFR*** (Quote IFR no. on all correspondence) Dear Re: The Exceptional Cases Committee met on (DATE) and discussed your request for funding for the above procedure. I am writing to inform you that the committee could not make a final decision until they had received further information from your referring clinician. I have written to request this further information. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number.

Yours sincerely

Sheila Dilks Executive Director of Patient Care and Professions

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Appeals Committee Approved â&#x20AC;&#x201C; Letter to referring Clinician

St Lukeâ&#x20AC;&#x;s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466095 Fax: 01484 466139 DATE e-mail: eccadministrator@kirkleespct.nhs.uk

IFR No: IFR*** (Quote IFR no. on all correspondence and invoices)

Dear Re:

DOB:

Treatment requested: The Appeals Committee met on (date) and discussed your request for funding for the above named patient to undergo (insert treatment/procedure). I am writing to inform you that the committee has agreed to this request. The Appeals Committee have over turned the original decision the Exceptional Cases Committee made. You may now make an NHS referral for this patient to a Care Quality Commission registered provider. Please enclose a copy of this letter with your referral as confirmation that Kirklees PCT has agreed the funding. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Dr Judith Hooper Executive Director of Public Health

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Appeals Committee Approved â&#x20AC;&#x201C; Letter to Patient

St Lukeâ&#x20AC;&#x;s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466095 Fax: 01484 466139 DATE e-mail: eccadministrator@kirkleespct.nhs.uk

IFR No: IFR *** (Quote IFR no. on all correspondence)

Dear Re: Request for The Appeals Committee met on (date) and discussed your request for funding for the above (insert treatment/ procedure) I am writing to inform you that the committee has approved this request. The Appeals Committee have over turned the original decision made by the Exceptional Cases Committee. I have written to your referring clinician who will now make the necessary arrangements to refer you. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Dr Judith Hooper Executive Director of Public Health

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Appeals Committee Declined – Letter to referring Clinician

St Luke‟s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466095 Fax: 01484 466139 DATE

IFR No: IFR*** (Quote IFR no. on all correspondence)

Dear Re:

DOB:

Treatment requested: Following the Appeals Panel meeting on (DATE), I regret to inform you that your request for the above patient to undergone the requested treatment has been declined. The Appeals Committee supported the original decision made by the Exceptional Cases Committee. The rational behind the decision was…………………. The Appeals Committee is the final stage of the PCT process. If there is a change in your patient‟s circumstances please feel free to make a new referral. Your patient has been informed of this decision. We are unable to discuss the details of individual cases over the telephone but if you have any enquiries regarding the process please do not hesitate to contact the Individual Funding Requests Co-ordinator on the above number. Yours sincerely

Dr Judith Hooper Executive Director of Public Health

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Appeals Committee Declined – Letter to Patient

St Luke‟s House Blackmoorfoot Road Crosland Moor Huddersfield HD4 5RH Tel: 01484 466095 Fax: 01484 466139 DATE e-mail: ecc.administrator@kirkleespct.nhs.uk

IFR No: IFR *** (Quote IFR no. on all correspondence) Dear Re: Request for Following the Appeals Committee meeting on (date), I regret to inform you that your request for the above procedure has been declined. The Appeals Committee supported the original decision made by the Exceptional Cases Committee. The recorded rationale behind the decision was …………………… The Appeals Committee is the final stage of the PCT process. If there is a change in your circumstances and you have the support from your clinician, a new referral can be made. If you are unhappy with the decision and the way in which the process was conducted you can make a complaint to Gillian Gabanski, Complaints Manager, at the above address who will advise you on the procedure to follow. Telephone: 01484 466000, email: Gillian.gabanski@kirkleespct.nhs.uk. Your referring clinician has been informed of this decision. Yours sincerely

Dr Judith Hooper Executive Director of Public Health

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Appendix F: Referral form for individuals with mental health issues or learning disabilities

PCT use Case No.

Out of Area Health Panel (Mental Health & Learning Disability) Referral Form

Please ensure that all relevant information is included in this form or is attached to ensure the request is processed in a timely manner. If not the form will be returned to you.

Patientâ&#x20AC;&#x2122;s Name:

DOB:

GP & Practice:

NHS No.

Patientâ&#x20AC;&#x2122;s Address:

Request for: (Please include 3 options of placement/treatment to meet identified needs, as appropriate, include provider details and cost if known)

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Clinical supporting information: (Please include a full holistic assessment with specialist information/assessments included as appropriate, eg patientâ&#x20AC;&#x;s current BMI, if relevant to request)

Previous Options tried: (Please include details of any previous out of area or self funded options)

Evidence base to support request:

What outcomes are expected?

Please complete as relevant with evidence:

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1. Not having the treatment would result in a real and imminent risk of harm:

2. The placement for treatment needs to be done within a strict time-frame, otherwise delay would result in it becoming ineffective.

Is the patient known to local services?

Y

N

(Please include name of service and care co-ordinator if known)

Name & address of referring clinician

Signature, position of referring clinician:

(please print):

Tel No:

Date form completed:

Fax No: Referral supported by: General Manager Kirklees

Y

N

Name:………………………………………………………… Please return the completed form to: Lead Nurse MH/LD Specialist Care Team Kirklees PCT Broad Lea House Bradley Business Park Dyson Wood Way Bradley Huddersfield HD2 1GQ Telephone: 01484 464000 Fax: 01484 464577 Please ring the number above for further information regarding making a referral

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Date received at the PCT: Date of Panel: Decision of Panel: Declined: Approved:

Referred to ECC:

Urgent or Emergency

Reasons, plus any actions to be taken:

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Appendix G: Process for considering Mental Health and Learning Disabilities related referrals

Referral to Lead Nurse (LN) within specialist care team: Full holistic Nursing assessment â&#x20AC;&#x201C; including specialist assessments, eg Low secure, Risk (note 1) Completed OOA proforma

LN to check full information is available â&#x20AC;&#x201C; take case to panel Yes (note 2) No (note 3)

Panel (note 4) meets weekly (if for any reason a member of the panel cannot attend then an appropriate replacement should attend) Decisions made will be confirmed back to referrers within 48 hours. If further information is requested (note 3)

Notes 1) Any request for Low Secure placements, (other than from regional forensic case managers) requires a specialist assessment completing from the Castlehill clinical team, prior to presentation at panel. (the assessment will be completed within 2 weeks of request & report provided within 1 week) 2) Completed accurate information has to be with the LN 72 hrs prior to the next panel to be included on the agenda 3) If the form is not completed fully the referrer will be asked for the missing information. There will be a maximum, 1 month period of time for the referring clinician to respond to the information queries. If no response is received within the timescale that request file, will be closed 4) Core Members: Kirklees: Chair- Assistant Director(mental Health); General Manager MH service Lead Nurse MH/LD specialist care team 5) Initial reviews will be completed by identified Clinicians/key workers/teams. Ongoing reviews will be completed by identified Clinicians/key workers/teams.; summary of outcome will be sent to LN. LN will complete an assessment / review on all cases where the decision is appealed. LN will attend joint reviews if a change to the package is required. LN will attend a joint review annually on all long stay cases. LN will update review summaries & outcomes on data base.

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6) LN will present additional request including clinical support information, outcomes achieved to date & expected outcomes LN to commission placement/treatment. Full liaison with clinicians & providers To record decision and update database within 48 hours.

Regular Reviews will take place with timescales determined by clinical need or determined by panel (note 5)

Changes to Packages LN will present an update to next Panel for consideration (note 6)

Urgent or Emergency cases It is recognised that there may be occasions when cases require a decision urgently. (for example, when it is identified that there is significant risk of self harm or risk to others), the chair of the panel will discuss the recommendations with the clinical lead and the decision will be recorded as per the above process, and included for information at the next panel meeting.

PCT Out of Area Contracts Where the PCT has an agreed contract with an independent provider, local referrers and services need to complete the above and seek prior approval before utilising the provision. Where the request is to access provision from a PCT Out of Area Contract the chair of the panel will discuss the recommendations with the clinical lead and the decision will be recorded as per the above process, and included for information at the next panel meeting.

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Appendix H: Membership of the Committees involved in the Individual Funding Requests process in Kirklees Screening Panel Senior Contracts Manager – Sandra Haigh (Deputy: Abigail Tebbs) Public Health Consultants - Sarah Muckle/ Dr Mercy Vergis Individual Funding Requests Coordinator – Claire Inwood Exceptional Cases Committee Director – Sheila Dilks (Chair) (Deputy: Helena Corder) Non-executive Director - Val Aguirregoicoa (Deputy: To be confirmed by Carol McKenna Professional Executive Committee Representatives – Dawn Gordon, David Wood and Sarah Bracknell Clinicians – Dominic Gary Assistant Directors – Vicky Dutchburn (Deputy: 2 names to be confirmed by Carol, Sheila and Judith) Individual Funding requests Coordinator – Mary Osborne (Deputy: To be confirmed) Appeals Committee Executive Director – Judith Hooper (Chair) (Deputy: Bryan Machin) Non-executive Director - Vanessa Stirum (Deputy: Tony Gerard) Professional Executive Committee Representatives – David Anderson (Deputy: To be confirmed) Clinician – Jim Lee Individual Funding Requests Coordinator – Claire Inwood

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Appendix I: Proforma for consideration by the Appeals Committee

Was the original ECC quorate?

Yes No

Did the ECC make the correct decision based on the information at the time?

Yes No

Has extra information been supplied?

Yes No

If extra information has been supplied has the case been referred back to ECC? Yes No Is the original ECC decision upheld?

Yes No

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Appendix J: Flow chart illustrating the exceptional cases process Referral by Clinician for consideration by ECC

Assessment by Screening Panel

Referral not appropriate according to criteria in screening matrix

Exceptional

Consistent with existing policy guidelines/evidence

Refer to next ECC for consideration

Inform referring Clinician and Patient

ECC

Approved

Not Approved

Inform referring Clinician and Patient

Appeal upheld Issues with ECC process/decision

Requests Appeal

Appeals Committee

Refused No issues with ECC process identified

Inform referring Clinician and Patient Supply information on what to do next if unhappy with decision

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Appendix K: Equality Impact Assessment Tool Insert Name of Policy / Procedure Yes/No 1.

Does the policy/guidance affect one group less or more favourably than another on the basis of:

Comments

No

Race

No

Ethnic origins (including gypsies and travellers)

No

Nationality

No

Gender

No

Culture

No

Religion or belief

No

Sexual orientation including lesbian, gay and bisexual people

No

Age

No

Disability - learning disabilities, physical disability, sensory impairment and mental health problems

No

2.

Is there any evidence that some groups are affected differently?

No

3.

If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable?

No

4.

Is the impact of the policy/guidance likely to be negative?

No

5.

If so can the impact be avoided?

N/A

6.

What alternatives are there to achieving the policy/guidance without the impact?

N/A

7.

Can we reduce the impact by taking different action?

N/A

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Appendix L: Key stakeholders consulted/involved in the development of the policy Key Participant Yes/No

Feedback requested Yes/No

Feedback accepted Yes/No

Dr Judith Hooper, Director of Public Health

YES

YES

YES

Carol McKenna, Director of Commissioning

YES

YES

YES

Sheila Dilks, Director of Patient Care and Professions

YES

YES

YES

Abigail Tebbs, Senior Contracts Manager

YES

YES

YES

Alison Bragg, Senior Contracts Manager

YES

YES

YES

Katrina Devall, Individual Funding Requests Administrator

YES

YES

YES

YES

YES

YES

Val Aguirregoicoa, Non Executive Director

YES

YES

YES

Vanessa Stirum, Non Executive Director

YES

YES

YES

Vicky Dutchburn, Assistant Director Commissioning

YES

YES

YES

Professional Executive Committee, NHS Kirklees

YES

YES

YES

Stakeholders name and designation

Philippa Richler-Potts, Senior Solicitor, Hempsons Solicitors

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