Policy for the Management of Unplanned Activity (UNPACS)

Policy for the Management of Unplanned Activity (UNPACS) 1. Process for consideration of an UNPACs application 1.1 Applications must be made in writing using the UNPACS application form (Appendix 1). In urgent cases a copy of the referral letter may be accepted. 1.2 All applications should be lodged with the designated officer from within the Medical Directorate. 1.3 Each application will be reviewed by the designated officer from within the Medical Directorate who will assess the competency and completeness of the application. 1.4 It is the responsibility of the referring clinician to complete the application form in full. Documentation that is incomplete will be returned for completion prior to consideration and this may result in a delay to the patient s care. The response time is taken from the time a complete application is received. The application must include a statement for the evidence base for clinical use, information regarding cost effectiveness and the factors relating to the individual nature of the case. 1.5 The referring clinician is required to demonstrate the clinical case for the patient to be referred for treatment not provided within mainstream services. This will include information relating to the patient s clinical circumstances which are significantly different from: The general population of patients. The population of patients included within the condition specific considerations. These circumstances imply that the patient is likely to gain significantly more benefit from the proposed treatment than would normally be expected. Such considerations should be taken on a case by case basis. 1.6 Only evidence of clinical need will be taken into consideration. 1.7 Clinicians may wish to seek support for the application from colleagues from either within NHS Ayrshire and Arran or from another NHS Board. The purpose of such peer support is to provide the requesting clinician with an opportunity to sense check their assessment of the potential added benefit that the patient would gain from the treatment in question. Similarly, where the care of the patient is under a multi-disciplinary team, clinicians may wish to consider seeking their support for the application. However, seeking such support should not adversely impact on the timescale for the application. 1.8 Factors such as gender, ethnicity, age, lifestyle or other social factors such as employment or parenthood will not be considered on the grounds of equality (the exception being access to gender reassignment services). 1.9 The fact that treatment might be efficacious for the patient is not, in itself, grounds for access. 1.10 Each application will be considered by the appropriate Associate Medical Director and the designated officer from within the Medical Directorate. Produced by: K Darling Page: 4 Review Date: tbc

Agreement is required by both parties to either support or refuse an application for funding. 1.11 In the rare event that a decision requires to be taken, where a delay in access would result in significant deterioration in the patient s condition, all attempts will be made to follow the above process. However, the designated officer from within the Medical Directorate may make a decision if unable to discuss with an Associate Medical Director (or Medical Director) within the necessary timescale. This will be within the bounds of the approved authorisation levels assigned. 1.12 The overall process will be consistent in every case and an audit trail of documentation, decision and communication will be retained. 1.13 A declaration of interest is required for all those involved in any application for funding i.e. decision makers and referrer. 2. Patient involvement 2.1 The patient (or patient representative) involvement will be through discussion with the requesting clinician who will make the referral and will represent the patient s interests. 2.2 Patients (or their representatives) wishing to see a copy of the UNPACS application documentation should access this through their clinician. 3. Evidence to be considered for an UNPACs request 3.1 The UNPACs decision will be based on a range of high quality, relevant evidence pertinent to the patient s clinical circumstances including: The rationale for the request including patient treatment history, prognosis and specific clinical characteristics. Information on the expected response and benefit. Consequences of not receiving the treatment from both a patient and service perspective. Consequences of using the treatment. Clinical effectiveness evidence base. Cost effectiveness information. 3.2 The following principles for the management of unplanned activity will be applied: All NHS providers are assumed to meet NHS Scotland governance requirements. Local NHS services, if available, have to be utilised prior to consideration of other services. If local services are not available or have not adequately addressed the problem, NHS services beyond the boundaries of NHS Ayrshire & Arran should be used (if available). The independent sector will only be considered as a third option. If a patient has arranged independent sector services by self-financing and subsequently requests NHS funding, this will not be approved if there are NHS services available. Produced by: K Darling Page: 5 Review Date: tbc

Clinical and cost effectiveness considerations will be undertaken and this may include evidence based reviews. Consideration of exceptionality will be undertaken i.e. is there anything in the patient s case that indicates that the patient would benefit more from the proposed treatment than other patients with the same condition. The referring clinician will be required to remain the local named clinician (or designate another clinician who agrees to be the local named person). The UNPACS process should not be used to circumvent established services and processes. A positive decision will not be considered as precedent setting, as each individual case will have a different set of circumstances. Referrals will only be accepted from medical practitioners. 4. Communication of UNPACs decision 4.1 The designated officer from within the Medical Directorate will give written confirmation of the UNPACS decision to the requesting clinician, within 20 working days of receipt of the written request. 4.2 The rationale for each decision will be included in the written response to the clinician. 4.3 Where an application is rejected, the written response will include information on the circumstances and process that can be used to appeal against the decision. 4.4 The requesting clinician should discuss the outcome of the UNPACS application with the patient in detail, and clarify the options open to the patient for future treatment. This should include contact details where the patient / patient s representative can obtain further support and advice. 5. Monitoring of UNPACS accessibility to services 5.1 The designated officer from within the Medical Directorate will ensure that accurate and up to date information is maintained on UNPACS requests and the outcomes, including the outcome of any appeals. 5.2 The Healthcare Governance Committee will review annually a report on the number of UNPACS requests and decisions as part of the necessary governance arrangements as defined within HDL (2005) 41. 6. Evaluation of UNPACs requests 6.1 Clinicians gaining access to UNPACS funding will be required to provide regular updates regarding treatment outcomes as specified at time of approval. 6.2 Where treatment is unsuccessful, the clinician is required to advise of this also. Produced by: K Darling Page: 6 Review Date: tbc

7. Independent Sector considerations 7.1 Within the UNPACs activity, independent sector providers are often utilised. Any new independent sector provider will require governance checks to be completed prior to any authorisation and placement being considered. 7.2 If a new independent sector provider is proposed, the following information is requested: Details on services and evidence on the extent to which the service reflects the evidence base. Audit processes. Outcome information. Complaints procedure. Condition specific information e.g. management of aggression. Proposed care pathway. Governance arrangements. 7.3 In addition, the Healthcare Commission (or equivalent) reports are reviewed. 7.4 Thereafter, the facility will be visited to determine the state of environment, to identify if stated actions are actually being implemented and to discuss NHS HDL (2005) 41 requirements. This will be completed prior to any final judgement on service appropriateness being made. 7.5 The timescale for responding to an UNPACS application will be extended to encompass this activity. Specifically, the clock will be stopped whilst the governance review is undertaken and re-started upon completion of the process. 7.6 Annual governance reviews will be undertaken for all currently approved providers and if appropriate, providers are required to provide individual patient progress reports, at agreed intervals. Produced by: K Darling Page: 7 Review Date: tbc

Unplanned Activity (UNPACs) Appeal ANNEX 2 Introduction The processes required to manage an appeal against an UNPACs decision are defined below. 1. Appeals against an UNPACs treatment request The process for consideration of UNPACS appeals will be as defined below. 1.1 Where an UNPACS decision has resulted in a particular treatment not being made available for an individual patient, then that patient, with the support of their clinician, has the right to appeal that decision. 1.2 Appeals may be made on the following grounds: The process for deciding the UNPACs application was not followed fairly i.e. due process was not followed. The decision cannot be justified on the basis of the evidence submitted. 1.3 An appeal will not be accepted for consideration solely because the patient or clinician does not agree with the decision reached, without reference to the grounds above (1.2). 1.4 An appeal can be submitted only where the clinician supports the patient s decision to appeal. 1.5 Where new evidence emerges after the UNPACs decision, or if the original decision appears to be based on factual inaccuracy, this will not be considered as an appeal. The decision will be referred back as a resubmission through the full UNPACs process. 2. Lodging an Appeal 2.1 The appeal should be lodged in writing to the Chief Executive, NHS Ayrshire and Arran. 2.2 The basis for the appeal should be stated with reference to the grounds noted in section 1.2. This may include a brief statement of the case to be made, together with any supporting documentation available at the time of the decision 2.3 Appeals will only be considered if they have the full support of the patient s clinician. 3. Consideration of the Appeal 3.1 The Chief Executive and Executive Medical Director will consider the request for the appeal. 3.2 The Chief Executive will inform the patient, normally within 10 working days, whether an appeal will be heard. 3.3 Where the appeal has a clinical urgency, this will be expedited in line with the urgency of the individual case. Produced by: K Darling Page: 8 Review Date: tbc

3.4 If consideration of an appeal is agreed, the Chief Executive will convene an UNPACS Appeals Panel. 3.5 Appeal panel hearings will normally be heard within 20 working days of confirmation that an appeal will be heard, and at all times in line with the clinical urgency of the appeal (see Appendix 1). 4. The Appeals Panel Membership and Management 4.1 Where an appeal hearing is required a Panel will be established with the following composition (see Appendix 2 for the appointments process). 4.2 The Panel will exclude any individual who considered the original application and will consist of: Non Executive Director of the NHS Board (Chairperson) Chief Executive of the NHS Board External expert A member of the public. 4.3 The Chair of the NHS Board may provide temporary nominations to the Panel if unacceptable delays would be caused by absence of members of the Panel. 4.4 The Corporate Business Manager will be responsible for the arrangements to set up the Appeals Panel. This will include forming and convening the Panel within the required timeline, arranging a suitable venue, distributing all necessary paperwork and documentation to facilitate discussion at the hearing. 4.5 The Corporate Business Manager will provide administrative support to record the main discussion and decision. 5. Patient Advocacy and Support 5.1 NHS Ayrshire and Arran recognise that the process of application, preparation and participation in appealing a decision regarding availability of health care may be challenging for a patient. 5.2 When an appeal is granted the Assistant Director of Nursing will allocate a dedicated patient support officer to support the patient through the appeals process. In addition the patient and / or their representative will be offered access to independent advocacy for advice. 5.3 The patient support officer will be the main point of contact between NHS Ayrshire and Arran and the patient prior to the Panel hearing. 5.4 The patient support officer will offer technical support to guide the patient through the Panel process. 5.5 The patient support officer will not offer any clinical advice regarding the specific case. 6. Prior to the Appeal 6.1 The date of the Panel hearing will be confirmed as soon as possible. 6.2 The patient will be given detail of the appeal hearing procedures by their patient support officer. This will include verbal and written advice regarding their right to be represented at the hearing. Produced by: K Darling Page: 9 Review Date: tbc

6.3 The patient, supported by their clinician, will be invited to submit additional information relevant to the appeal that they wish to be considered. 6.4 The designated officer from within the Medical Directorate will provide the UNPACS management case to the Chief Executive together with any supporting documentation. All information must be received at least 7 working days prior to the appeal hearing. 6.5 Papers will normally be issued 5 working days prior to the Panel hearing. This will include copies of any additional papers relevant to the appeal. 6.6 Where there is a clinical urgency, the process timeline will be commensurate with the individual case. 7. Attendance at the Appeal hearing 7.1 The patient and / or their representative will be invited to attend the appeal hearing. 7.2 The patient s clinician will be invited to the appeal hearing, either in person or via a tele link. If this is not possible, then a written testimony may be submitted, with approval of the Panel chair. 7.3 The designated officer from within the Medical Directorate is required to attend the appeal hearing in person to present the case for the UNPACS decision. 7.4 All parties may be present during the hearing of the appeal. However, they will not be present when the panel is considering its decision. 7.5 The presence or otherwise, of the patient and / or their representative will have no bearing on the outcome, as patients will not be disadvantaged if they choose not to attend. 8. Proceedings at the Appeal Hearing 8.1 An agenda for each appeal hearing will be established according to the following framework (see appendix 3). 1. Welcome and introductions 2. Outline of the appeal hearing process 3. Presentation of the Clinical UNPACS case. If the requesting clinician chooses to attend they will present the clinical case. In the absence of the clinician the Panel will consider the written submission. - Clarification of any points arising 4. Presentation of the UNPACS decision and rationale designated officer from within the Medical Directorate - Clarification of any points arising 5. Presentation invited from patient or representative 6. Invitation to all parties to sum up firstly, the designated officer from within the Medical Directorate, then the patient or representative 7. Panel retires to consider case and reach a decision 8. Panel is reconvened 9. Chair delivers the decision of the Panel and the basis for the decision. 8.2 Points of clarification and questions will normally be directed towards the patient s clinician, the officers of NHS Ayrshire and Arran or the external expert. Produced by: K Darling Page: 10 Review Date: tbc

8.3 Following the hearing of all the evidence and supporting comments, the Panel will retire to consider the case in private. 8.4 The Chair of the Panel may recall the patient, clinician or designated officer from within the Medical Directorate to clarify any points of uncertainty or ambiguity. 8.5 If a recall is necessary, all parties are invited to be present, notwithstanding only one party may be concerned with the point giving rise to doubt. 8.6 On reaching a decision the Panel will reconvene with the patient, clinician and designated officer from within the Medical Directorate in attendance. The Chair will inform all parties of the decision and the basis of the decision. 8.7 In the case of a split decision of the panel, the Panel Chair has the casting vote. 9 Procedures following the Appeal 9.1 The Chief Executive of NHS Ayrshire and Arran will give the patient and the designated officer from within the Medical Directorate written confirmation of the decision of the Panel. 9.2 This response will indicate that the decision is final in terms of NHS Ayrshire and Arran. The patient will be informed that this does not prevent them from seeking further legal advice outwith the Panel process. 9.3 The patient should also be advised that a complaint regarding the process may be lodged which will give access to appeal to the Ombudsman. Produced by: K Darling Page: 11 Review Date: tbc

APPENDIX 1 REQUEST FOR UNPLANNED ACTIVITY / EXCEPTIONAL CASE CONSIDERATION 1. Patient details Name Date of birth Address Previous UNPAC reference number (if applicable / known) 2. Clinical condition Please provide a summary of the clinical condition of your patient as well as the treatments and interventions pursued thus far. Produced by: K Darling Page: 12 Review Date: tbc

3. Possible and preferred interventions Please outline your preferred intervention and include others considered and rejected. Please provide a rationale as to why this is the preferred treatment, including the evidence base and references where appropriate. Please note that private sector provision should only be considered where NHS services locally and NHS services elsewhere can be demonstrated to be inappropriate. 4. Exceptionality Please describe why this patient s case is considered to be exceptional i.e. the outcome is likely to be of greater benefit to this patient than the general population of patients or other patients with this condition. 5. Outcomes sought Please describe the outcomes and benefit you would expect your patient to derive from treatment. Produced by: K Darling Page: 13 Review Date: tbc

6. Funding What is the estimated cost for which you are seeking authorisation? Please provide an outline of component parts, where appropriate, as well as summarise the certainty with which these estimates can be made. If these are not available to you, from where could such estimates be sourced? Is the proposed treatment cost effective? 7. For Private Sector Referrals Only who would remain the responsible NHS consultant or GP? Please provide name and contact details. 8. Independent clinical assessment. In many instances the view of an independent clinician is sought in formulating decisions very often from Clinical / Service Directors, Associate Medical Directors and Medical Directors. If you have already sought this advice and guidance please use this section to reflect this. 9. Patient / relative information Has the referral been discussed with the patient and / or relatives? If yes, what is / are their views? 10. Referrers name and contact details Please provide details of the referring clinician from whom any further details can be sought. Produced by: K Darling Page: 14 Review Date: tbc

11. Potential conflict of interest Please provide details of any potential conflict of interest from either the referrer or any member of the referring multi-disciplinary team. COPIES OF THIS FORM ARE AVAILABLE ELECTRONICALLY FROM KAREN DARLING COMPLETED FUNDING REQUESTS SHOULD BE SUBMITTED TO KAREN DARLING, A designated officer from within the Medical Directorate / Karen.Darling@aapct.scot.nhs.uk / 60 Lister Street, University Hospital Crosshouse, Kilmarnock 01563 825 859 Fax 01563 825 806 Produced by: K Darling Page: 15 Review Date: tbc

APPENDIX 2 Process Map for the UNPACS Appeals Panel Consideration of appeal denied Patient lodges an appeal against an UNPAC Decision Request for appeal considered by Chief Executive and Non Executive Director Consideration of appeal granted Refer back to UNPAC panel to reconsider 1 0 W O R K I N G Chief Executive advises patient in writing that there are no grounds for appeal Chief Executive advises patient in writing that an appeal has been granted Chief Executive arranges an Appeals Panel (AP) Chief Executive advises Assistant Director of Nursing that patient support is required AP Decision Verbally communicated to all parties D A Y S 2 0 W O R K I N G D A Y S AP Hearing Chief Executive advises patient and designated officer from within the Medical Directorate in writing of the AP decision Produced by: K Darling Page: 16 Review Date: tbc

APPENDIX 3 Appointments to an UNPACS Appeal Panel 1. Chair of the Panel A Non Executive Director of the NHS Board The Chair of the Panel will be nominated by the NHS Board on an annual basis (each April). The Chair of the Panel will be fully briefed regarding the process of UNPACs applications and the associated local procedures. All Non Executive Directors of the NHS Board will be briefed, on an annual basis on the background and procedures associated with consideration of an appeal against a decision regarding availability of treatments requested. This will allow urgent appeals to be held where the nominated Non Executive Director is absent or unavailable. 2. Chief Executive of the NHS Board 3. External Expert This will be a clinician with recognised expertise in the area in question. The Chair of the Panel will select the external expert to reflect the matter being considered. Officers of NHS Ayrshire and Arran will provide support in this regard. 4. A member of the public Members of the public will be identified from a list maintained and updated annually by the Assistant Director of Nursing. This list will be drawn from established lay groups Public Partnership Forums and the Patients Council. All members of the public who have agreed to participate in a Panel will be briefed, on an annual basis on the background and procedures associated with consideration of an appeal against a decision regarding availability of a treatment. Produced by: K Darling Page: 17 Review Date: tbc

APPENDIX 4 UNPACS Appeal Agenda NHS Ayrshire and Arran UNPACS Appeal Panel Held on <date/time> In <Venue> AGENDA 1. Welcome and introductions 2. Outline of appeal hearing process 3. Presentation of the Clinical UNPACS case. If the requesting clinician chooses to attend they will present the clinical case. In the absence of the clinician the Panel will consider the written submission. - Clarification of any points arising 4. Presentation of the UNPACS decision and rationale designated officer from within the Medical Directorate - Clarification of any points arising 5. Presentation invited from patient or representative 6. Invitation to all parties to sum up firstly the designated officer from within the Medical Directorate, then the patient or representative 7. Panel retires to consider case and reach a decision 8. Panel is reconvened 9. Chair delivers the decision of the Panel and the basis for the decision. Panel Members Name Designation Non Executive Director NHS Ayrshire & Arran Chief Executive NHS Ayrshire & Arran External Expert Lay representation In attendance Name Designation Patient and / or their representative Patient s clinician Designated officer from within the Medical Directorate Produced by: K Darling Page: 18 Review Date: tbc