Individual Funding Requests Policy (and Operating Procedures)

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Individual Funding Requests Policy(and Operating Procedures)

Individual Funding Requests Policy(and Operating Procedures)Version HistoryVersionDateAuthorReason for changeV.1.00January 2015New Policy based on West MidlandsDocumentV.1.01Feb 2015IFR TeamFollowing a revision of the service moredetail added to policyV.2.0015 September 2015Interim IFR ProjectManagerRevision to meet current standards,formatted to CCG standard.Review and Approval:Reviewed byDateOriginal Policy (V.1.00) approved by both Clinical ExecutivesJanuary and April 2015Reviewed By K Smith Head of Patient Safety and Clinicaleffectiveness15/7/15Reviewed and recommended by IFR PanelSeptember 2015Presented to Clinical Executive7/10/15West Suffolk CCGPresented to Clinical ExecutiveSeptember 2015Ipswich and East Suffolk CCGApproval by Clinical Scrutiny Committee4 November 2015West Suffolk CCGApproval by Clinical Scrutiny Committee3 November 2015Ipswich and East Suffolk CCGNext review dateAugust 2018Version V.2.00 October 2015Page 2 of 29Uncontrolled copy when printed

Individual Funding Requests Policy(and Operating Procedures)ContentsVersion History . 2Review and Approval: . 2Next review date . 2Contents . 31. Introduction . 52. Purpose . 53. Roles and Responsibilities . 53.1. The IFR Panel. 53.2. Conflicts of interest . 63.3. Training for IFR Panel Members . 63.4. IFR Triage. 63.5. Role of the IFR Lead . 73.6. Responsibilities of the Administration Team . 74. Submissions . 74.1. Who can make a submission? . 74.2. Application form . 84.3. Responsibilities of the requesting clinician . 84.4. IFRs can be withdrawn . 85. The Process. 85.1. Receipt of a submission . 85.2. Check for Completeness. 95.3. Check to determine whether this is a proper application to go before the IFR Panel . 95.4. Determining Clinical Exceptionality . 105.5. Redirection of inappropriate requests . 105.6. Assigning submissions for consideration by IFR Panel . 105.7. Fast-tracking urgent IFRs . 106. The IFR Panel Meeting . 116.1. Agenda and supporting papers . 116.2. Management of the Meeting . 116.3. Principles to be applied by the IFR Panel. 126.4. Recommendations available to the Panel . 136.5. Deferred submissions . 136.6. Conditional approval . 136.7. Record of Panel meetings and confidentiality . 136.8. Communicating the Panel’s outcome . 157. Reporting, Quality Assurance Checks and Archiving . 158. Proposed Time Periods for Stages of the IFR . 169. Dissatisfaction with the IFR Panel Decision . 169.1. Grounds for Review . 179.2. Requesting a Review . 1710.Remit of the IFR Review Panel. 1710.1.Administration of the Review Process . 1810.2.Information provided by the clinician or patient . 1910.3.Actions in advance of the meeting . 1910.4.Minutes . 2010.5.Communicating the decision . 2010.6.Next steps . 2010.7.Filing and archiving . 2011.Proposed time periods for stages of the Review Process . 2012.Monitoring Compliance . 2113.Definitions and Glossary of Terms . 2114.References . 23Version V.2.00 October 2015Page 3 of 29Uncontrolled copy when printed

Individual Funding Requests Policy(and Operating Procedures)Appendix A . 25IFR Process Flow Charts . 25Submission of Funding Request. 25Dissatisfaction with the Decision of the IFR Panel . 26Appendix B: . 27Equality Impact Assessment . 27Version V.2.00 October 2015Page 4 of 29Uncontrolled copy when printed

Individual Funding Requests Policy(and Operating Procedures)STATEMENT OF OVERARCHING PRINCIPLESAll Policies, Procedures, Guidelines and Protocols of the NHS West Suffolk and Ipswichand East Suffolk Clinical Commissioning Groups (the CCGs) are formulated to complywith the overarching requirements of legislation, policies or other standards relating toequality and diversity.1.IntroductionClinical commissioning groups, West Suffolk CCG and Ipswich and East Suffolk CCG, commissionlocal NHS health services. NHS England commissions highly specialised health services. Eachorganisation use national and local policies to prioritise treatments based on available resourcesand competing demands.We recognise that there will always need to be a process for considering making additional NHSfunding available for the atypical or uncommon patient. The Clinical Commissioning Groups havean Individual Funding Request Panel to perform this function.Where a commissioning policy exists, the Individual Funding Request Panel considers whetherthere are sufficient grounds to agree funding for a treatment contrary to our commissioningdecision not to fund the treatment for the population in general. The process for consideration inthese circumstances is whether ‘exceptionality’ has been demonstrated by the evidence presented.When the patient is suffering from a presenting medical condition for which the CCG has no policythese will be considered as “individual request” or rarity request.The CCGs will be able to demonstrate that their decisions are based on sound principles and havebeen made after careful consideration of all the relevant factors, with reference to local conditions,and with a conscious intent to avoid discrimination.2.PurposeThe purpose of this document is to ensure that there is a clear process to consider requests for theprovision of treatments which are not normally commissioned, or not normally funded.That requests are considered fairly, rationally and consistently and the process will operate inaccordance with the requirements of current national guidance.3.Roles and Responsibilities3.1. The IFR PanelThe IFR Panel is responsible for recommending to the CCGs whether Individual FundingRequests should be funded or not, subject to exceptionality being demonstrated.The IFR Panel will sit monthlyMembers of the IFR Panel will be drawn from a pool of suitably qualified and trained memberswhich includes: GPs; Consultants in Public Health; Appropriate CCG representatives Pharmacists; and Lay members.A legal indemnity will be provided by the CCG, to all legal liabilities of members of the IFR Panel whoVersion V.2.00 October 2015Page 5 of 29Uncontrolled copy when printed

Individual Funding Requests Policy(and Operating Procedures)act in good faith; Members must have attended induction training, and ensure that they are fully familiarwith the IFR policy and operating procedures, before sitting on a Panel. Members should attend a training session at least once every year, and sit on Panels atleast twice a year, in order to retain their qualification to serve.The quorum for an IFR Panel is four members, which must include at least one lay person, and at leastone clinically-qualified person. It is legitimate for one individual (other than the lay person) to “weartwo hats”. As far as practical, the combination of members should be selected to provide a goodrange of perspectives and relevant skills.The IFR Panel may be chaired by any of the members provided that s/he has sat as an IFR Panelmember at least four times. The Chair must be identified in advance of the meeting, and must beavailable to approve the minutes and fulfill any other obligations within the specified time frame.The IFR Panel may call for specialist clinical, legal, financial, or other advice as appropriate.3.2. Conflicts of interestConflict of interest means any activity, commitment, or interest that may adversely affect, compromise,or be incompatible with the obligations of a Panel member. It includes but is not limited to situationswhere a significant financial or other interest could affect a Panel member’s judgment. Personalknowledge outside of the NHS of any IFR applicant shall usually amount to a conflict of interest.Members will be required to declare their interests before joining the Panel pool. The IFR Lead will bein a position to bear these in mind when organising Panels. As an additional safeguard, at thebeginning of every meeting, the Chair should require any member to declare any relevant interests.Anyone declaring any interest may, depending on the nature of the interest be required by the Chairnot to take any part in any discussion or outcome of the relevant case or vote.3.3. Training for IFR Panel MembersTraining will cover the following areas: IFR policy and process, including Reviews; Legal aspects of the work of IFR Panels; Healthcare ethics and applying the Healthcare Ethical Framework to decision-making; Consensus decision-making; Commissioning practice and CCG funding decisions; Critical appraisal skills; Methods of assessment of clinical and cost effectiveness; Confidentiality, data security, Caldicott principles and the requirements of the DataProtection Act and the Freedom of Information Act; and CCG complaints process.3.4. IFR TriageThe Triage Group is a working sub-group of the IFR Panel.All submissions to the IFR process will be triaged. The purpose of the triage is to ensure that: all appropriate information with each request has been submittedVersion V.2.00 October 2015Page 6 of 29Uncontrolled copy when printed

Individual Funding Requests Policy(and Operating Procedures) sufficient information has been submitted to allow a decision regarding clinicalexceptionality. identify service development requirements, a request for a treatment should be classifiedas a request for a service development if there is likely to be a cohort of similar patientswho areoin the same or similar clinical circumstances as the requesting patient whose clinicalcircumstances mean that they could make a likewise request.AndoWho could reasonably be expected to benefit from the requested treatment to thesame or similar degree. redirecting inappropriate submissions as required for example, contacting the contractsteam or requesting further information. Sufficient information has been provided on the available clinical and cost effectivenessinformation on the requested intervention to allow decision making3.5. Role of the IFR LeadKey elements of the IFR Lead’s role will be: Managing the work of the Administration Team; Establishing the protocols for communicating and liaising with patients andclinicians; With the Triage Group, triaging submissions to the IFR process, identifying servicedevelopment requirements, and redirecting inappropriate submissions as required; Contribute to the decision on whether submissions should be fast-tracked; Determining the additional information, specialist advice and reviews of evidencenecessary to inform the Panel’s recommendation; Contributing to the recruitment and training of Panel members; Contributing to the continuing development of the IFR process3.6. Responsibilities of the Administration TeamThe Administration Team will be responsible for:4. Administering the paperwork, ensuring the efficient handling and documentation ofsubmissions, from first receipt through to archiving; Maintaining patient confidentiality and data security in accordance with informationGovernance and Caldicott Guidelines; Organising the IFR Panel meetings, and acting as Secretary to the meetings; Correspondence; and Progress chasing.Submissions4.1. Who can make a submission?IFRs may be submitted by the following NHS personnel: consultant, GP or anequivalent autonomous NHS practitioner provided s/he will be responsible for administeringthe treatment. The person making the request is referred to in this policy as “the requestingclinician”. Patients may not make applications directly.Version V.2.00 October 2015Page 7 of 29Uncontrolled copy when printed

Individual Funding Requests Policy(and Operating Procedures)4.2. Application formAn application form ensures that relevant information is provided by every clinician for every IFR,regardless of the nature of intervention / treatment requested or the patients’ condition.Using an application form makes a significant contribution to consistency of decision-making bypresenting comparable information in a structured format to the IFR Panel.The application forms are available at http://www.ipswichandeastsuffolkccg.nhs.uk orhttp://www.westsuffolkccg.nhs.ukPersonal and confidential information about the patient and the clinician will not be shared with theIFR Panel. However, depending upon the individual clinical circumstances it may be necessaryto re-introduce information on the patient’s age and/or sex for consideration by the IFR Panel.From time to time it may also be necessary to edit the text provided by clinicians to removeinformation which could compromise the patient’s anonymity.Whilst maintaining the confidentiality of patients is of paramount importance, there are alsobenefits to assuring the anonymity of requesting clinicians.4.3. Responsibilities of the requesting clinicianThe requesting clinician is required to affirm that s/he has discussed the proposedtreatment with the patient (or has offered such a discussion) and obtained consent before theapplication is made for funding on his/her behalf.The requesting clinician must make the patient aware of the implications of embarking on thisprocess, particularly that it may take some time before the request can be decided and, if thepatient is considering privately funding the requested treatment while the IFR is being consideredthat no retrospective funding is available even if the IFR is approved.It is the responsibility of the requesting clinician to ensure that all the required information issubmitted on the approved IFR request form, including the rationale, clinical evidence, costeffectiveness information and evidence to support the case for exceptionality where appropriate.When an IFR is submitted by a GP it is expected that s/he will have fully considered whether this isthe correct process to use.When an IFR is submitted by an NHS consultant or equivalent practitioner, nationalguidance requires the submission to be approved by the designated representative of the providerTrust. In the case of an IFR for a drug this is likely to be the Chief Pharmacist. For othertreatments it may the business manager of the department where the treatment will be provided.4.4. IFRs can be withdrawnAn IFR can be withdrawn at any time by written notice from the requesting clinician, advising theIFR Team on the reason for withdrawal. For example, it may be necessary to withdraw if thepatient opts for an alternative course of treatment, to fund the treatment privately, or if the patientdies.5.The ProcessSee Appendix A for Flow chart5.1. Receipt of a submissionOnly submissions set out on the standard form, and providing all the required information, willenter into the IFR process.Version V.2.00 October 2015Page 8

funding available for the atypical or uncommon patient. The Clinical Commissioning Groups have an Individual Funding Request Panel to perform this function. Where a commissioning policy exists, the Individual Funding Request Panel considers whether there are sufficient grounds to ag

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