GOVERNING BODY PAPER - Greenwich CCG · GOVERNING BODY PAPER Title of paper: To approve the...

Enclosure: JAgenda item: 12

GOVERNING BODY PAPER

Title of paper: To approve the Independent Funding Requests (IFR) Policyfor 2014/15

Date of meeting: 21st May 2014Presented by: Dr Mukul Agarwal Title: Clinical Project Lead for IFRPrepared by: Nicola Howe Title: Head of Specialised Commissioning Services,

South London CSU

Summary of Strategic Objectives Supported by this Report (X)

Improve health outcomes x To assure and drive improvements in quality xEnsure access to high quality primarycare services

x Meet statutory obligations

Ensure access to high qualitysecondary care services

x Take a long term approach to the healthneeds of the local population

Building a new Clinical CommissioningGroup

Enhance communications with practices andpatients

x

Enhance the use of information xPlease provide brief executive summary:-

The attached policy has been agreed by the IFR teams in the six South East LondonCCGs. It was approved by the Greenwich Executive Committee on 30th April and is nowpresented to the Governing Body for final approval.

Summary of Impact Assessment and Risk Management Issues (x)

(please provide detail in the body of the report)

Impact on Risk Assurance Framework (x) Yes X No N/AImpact on Environment (x) Yes X No N/ALegal Implications (x) Yes X No N/AResource implications (x) Yes X No N/AEquality impact assessment (x) Yes X No N/ANHS Operating Framework areas of Quality, Reform and finance(x)

Yes No N/A

Patient and Public Involvement (x) Yes No N/ACommunications and Engagement (x) Yes No N/AImpact on CCG Constitution (x) Yes No N/ABrief Summary of Recommendations

1. To approve the IFR Policy for 2014-15

South London IFR Policy v1.5

1

South London Individual FundingRequests (IFR) Policy –

(v1.5)

Enclosure J


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List of South London Clinical Commissioning Groups:

Version Control Record:

Version Description of Change(s) Reason for Change Author Date1.0 Creation of SL CSU IFR

PolicyCreating a single standardpolicy for all SL CCGs

SL CSU October2013

1.1 Changes agreed at policymeeting on 15

thNovember

2013

Discussion at meeting SL CSU December2013


thDecember

2013

Discussion at meeting SL CSU December2013


thJanuary 2014

Discussion at meeting andfeedback on V 1.2

SL CSU February2014

1.4 Changes made as a result ofcomments from IFR Policygroup representatives andaddition of equality statement

Review of changes made to V1.3 and addition of equalitystatement to comply SLCSUwith Equality AnalysisGuidance

SLCSU February2014

1.5 Changes made following therelease of V1.4. Amendmentto section 3.0.2. Removal ofrarity definition section 5.05.Amendment to section 6.2.Addition of other documentswhich have informed thepolicy.

Review of changes made to V1.4

SLCSU February2014

Croydon CCG Kingston CCG Merton CCG

Sutton CCG Richmond CCG Wandsworth CCG

Bexley CCG Greenwich CCG Lambeth CCG

Lewisham CCG Southwark CCG Bromley CCG


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Equality Statement:

This document demonstrates the organisation’s commitment to create a positive culture ofrespect for all individuals, including staff, patients, their families and carers as well ascommunity partners. The intention is, as required by the Equality Act 2010, to identify,remove or minimise discriminatory practice in the nine named protected characteristics ofage, disability, sex, gender reassignment, pregnancy and maternity, race, sexual orientation,religion or belief, and marriage and civil partnership. It is also intended to use the HumanRights Act 1998 and to promote positive practice and value the diversity of all individuals andcommunities”.

ContentsContents..................................................................................................................................................3

1 Introduction ....................................................................................................................................5

2 Purpose ...........................................................................................................................................5

3 Scope – Applications for Individual Funding Requests ...................................................................5

4 Responsibilities ...............................................................................................................................6

4.1 South London Administrative IFR Service:..............................................................................6

4.2 The CCGs: ................................................................................................................................7

4.3 IFR Panel and Appeals Panel: ..................................................................................................7

4.4 Panel Chair ..............................................................................................................................8

5 Definitions.......................................................................................................................................8

6 The IFR Process ...............................................................................................................................9

6.1 Submitting an IFR....................................................................................................................9

6.2 Patient Consent.....................................................................................................................10

6.3 Anonymity & Confidentiality.................................................................................................10

6.4 Evidence Base .......................................................................................................................11

6.5 Correspondence and Communications.................................................................................11

6.6 Photographic Evidence .........................................................................................................11

6.7 Urgent Applications ..............................................................................................................12

6.8 Clinical Triage ........................................................................................................................12

6.9 The IFR Panel.........................................................................................................................13

7 Appeals Process ............................................................................................................................14

8 Commissioning Process.................................................................................................................15

8.1 Service Developments...........................................................................................................15

8.2 Local decision-making (outside the IFR remit)......................................................................15


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9 Monitoring Compliance ................................................................................................................16

10 Policy Review ............................................................................................................................16

11 References ................................................................................................................................16

12 Associated Documentation.......................................................................................................16

Appendix A – IFR Process Flowchart.....................................................................................................17

Appendix B – IFR Application Form.......................................................................................................18

Appendix C - IFR Triage Meeting: Terms of Reference .........................................................................18

Appendix D – IFR Panel Terms of Reference.........................................................................................18

Appendix E – IFR Appeal Panel Terms of Reference.............................................................................18

Appendix F – Ethical Decision Making Framework...............................................................................18

Appendix G – Equality Analysis .............................................................................................................18


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1 Introduction

1.0.1 Acute patient care for the population of South London is delivered through contractswith acute care providers which are managed by South London CommissioningSupport Unit (SL CSU) on behalf of the Clinical Commissioning Groups (CCGs)within South London. The NHS exists to serve the needs of all patients but also has astatutory duty not to exceed the resources allocated to it by central government (NHSAct 2006). CCGs therefore need to use their limited resources effectively to obtainthe best healthcare possible for their population. This sometimes results in difficultdecisions having to be made about how resources should be prioritised whenservices are commissioned. There may be individual cases where a patient’s needscannot be met through existing contracts and commissioning arrangements but theirGP or consultant considers that their patient has a need for an un-commissionedtreatment and wishes to request funding on their patient’s behalf. When requestsoccur, CCGs must have a robust and transparent system in place to assess anddetermine whether the request should be funded, demonstrating a rational decisionmaking process for an individual patient. These are referred to as individual fundingrequests (IFRs).

1.0.2 The NHS Constitution1 sets out the following public commitment:

‘You have the right to expect local decisions on funding of drugs and treatments to bemade rationally following a proper consideration of the evidence. If the local NHSdecides not to fund a drug or treatment you and your doctor feel would be right foryou, they will explain that decision to you.’

2 Purpose

2.0.1 A single, joint South London Individual Funding Request (IFR) Policy ensures thateach South London CCG is operating to a model of best practice for IFRs; includinggovernance, key performance indicators and statutory duties. This Policy sets out theprinciples, organisational structures and relationships that are required to be in placeto assure CCGs that requests which fall outside the usual commissioningarrangements and contracts are dealt with efficiently, consistently, fairly andtransparently.

3 Scope – Applications for Individual Funding Requests

3.0.1 This policy applies to all written requests for IFRs submitted on behalf of patientsregistered to South London CCGs by NHS contracted responsible clinicians(including GPs, Consultants and equivalent autonomous practitioners) who areresponsible for administering the treatment. This policy excludes treatments andinterventions managed and commissioned by NHS England.

3.0.2 This policy excludes requests for funding approval made after an episode of care hascommenced or requests from patients for reimbursement of the costs of a treatmentwhich has been purchased privately. Retrospective funding requests for any care ortreatment which has not been given prior approval will not be funded, unless it can bedemonstrated that the treatment was needed urgently to avoid a life threatening

1NHS Constitution 2012– seven key principles


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situation or significant harm to the patient, and that unsuccessful efforts were madeto contact the IFR Team.

3.0.3 This Policy is for implementation and for use by the South London IFR AdministrationService and CCG triage and IFR and Appeal Panels.

3.0.4 The Policy is to be formally approved by individual CCG Governing Bodies. It is toinform and provide assurance that the IFR service is administered in accordance withgood practice, to the following:

South London CCG Governing Bodies South London CSU Senior Management Team Patients and Members of the Public Referring GPs and consultants and equivalent autonomous practitioners who are

responsible for administering the treatment Acute service provider organisations commissioned by South London CCGs

It will also be made available for information to members of the public.

4 Responsibilities

The responsibilities for implementation of the IFR policy are set out below.

4.1 South London Administrative IFR Service:

It is the responsibility of the South London IFR administrative service, working onbehalf of each CCG:

4.1.1 To receive, acknowledge and process all requests for Individual Funding submitted tothe CCG within the agreed time limits.

4.1.2 To undertake administrative triage to determine if the application is for the CCG,whether the request has sufficient information and to ensure appropriateconfidentiality for patients and panel members (against the agreed minimum dataset) for the request to be considered by a triage panel.

4.1.3 Where an application is lacking sufficient information to contact the applicant for theadditional information which would allow the request to be considered in the firstinstance by a triage panel.

4.1.4 To re-direct applications as appropriate.

4.1.5 To prepare panel papers and to forward to members in a manner that maintainspatient confidentiality through posting by Recorded Delivery or by emailing to asecure email address

4.1.6 To co-ordinate the process of triage assessment and consideration by IFR Panels inline with agreed policies and procedures and according to the timelines agreed.

4.1.7 To ensure that all appeals made against decisions of the IFR Panels are submitted tothe Appeal Panel, if appropriate.


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4.1.8 To communicate the outcome of the triage, IFR or Appeal panel to the applicant andwhere appropriate to the patient, their carer or guardian.

4.1.9 Report on IFR panel activity across South London CCGs to identify approvals,appropriate requests and potential service developments to inform future decisionmaking and determination of commissioning pathways in line with the agreedcontract.

4.1.10 To ensure that members are appropriately trained for participation in panels.

4.2 The CCGs:

The responsibility of the CCGs includes:

4.2.1 The appointment of panel members to act on behalf of the CCG.

4.2.2 To ensure that sufficient panel members are available from the CCG for panels to bequorate.

4.2.3 To ensure panel members: have access to confidential meeting papers sent via a secure email address. work to agreed frameworks for IFR panel decision making attend appropriate training.

4.2.4 To identify a CCG IFR Lead who will be the primary CCG contact for the IFR service.

4.2.5 The IFR Lead will present reports and policies to the CCG Governing Body forapproval and adoption in line with the CCG Governance arrangements.

4.2.6 Having governance arrangements in place to ensure that the IFR Panel isaccountable to the CCG Governing Body. (TORs for IFR panels can be found inappendix D)

4.2.7 To determine the Financial Limits to which the IFR panels can make fundingdecisions. To define the process for application outside Financial Limits in line withlocal Standing Financial Instructions (SFIs) ensuring that the CCG can act quickly toconfirm authorised expenditure over the approved threshold.

4.2.8 Agree and sign-off the access policy (Treatment Access Policy (TAP) in South EastLondon / Effective Commissioning Initiative (ECI) in South West London) againstwhich applications for some procedures are considered.

4.3 IFR Panel and Appeals Panel:

The responsibilities of the IFR Panel and Appeal Panel includes:

4.3.1 The IFR Panel and the Appeals Panel will be accountable to the CCGs GoverningBodies.

4.3.2 The IFR Panel is responsible for upholding and working within the ethical decisionmaking framework with regards to consideration of applications Appendix F


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4.3.3 The IFR Panel will refer to the relevant CCG adopted access policies to determinewhether a patient who does not meet the criteria in the policy can be considered tobe exceptional taking the information provided with the application into account.

4.3.4 The IFR Panel will be provided with details of all cases that have been determined atthe triage stage including the decision made and the reason for the decision.

4.3.5 The Appeal Panel will review applications where the applicant appeals the decisionmaking process of the IFR Panel and does not provide any new information forconsideration.

4.3.6 The membership of an Appeal Panel will exclude any persons who have previouslyconsidered the application for which the decision is appealed.

4.3.7 An Appeal Panel may not change the decision of the Triage or IFR panel, but mustconsider whether the decision reached: (see also 7.0.6)

Followed policy and procedures Took into account and weighed all relevant information available at the time Was reasonable and in line with the evidence Did not take into account any irrelevant information

4.3.8 The Appeal Panel may refer the case back to the original IFR panel for a re-consideration of the case should it consider that the IFR Panel did not fully followpolicies or procedures or had failed to take account of all relevant information

4.3.9 The Appeal Panel will be provided with all relevant documentation, correspondence,a synthesis of the evidence base and minutes summarising the basis for the originaldecision.

4.4 Panel Chair

4.4.1 The Panel Chair will be nominated by the CCG as a whole or the IFR panel itself.

4.4.2 He/she must be available to approve the minutes/letters within the specified timeframe following IFR panel meetings and to ensure that decisions made are correctlyreflected in the minutes.

4.4.3 He/she must confirm that the meeting is quorate in line with the terms of reference.

4.4.4 He/she may take a decision as ‘Chair’s Action’ for urgent cases discussed either atan urgently convened panel meeting or through a virtual panel comprising discussionand response from at least three panel members ensuring that this includesmembers with relevant clinical expertise.

5 Definitions

5.0.1 An Individual Funding Request (IFR) – is a request for an individual patient to fund,an episode of healthcare that falls outside existing contracts and commissioningarrangements entered into by South London CCGs.

5.0.2 An appropriate IFR is where:


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a patient’s treatment falls outside generic or treatment-specific policies where anunusual (‘exceptional’) circumstance applies to the individual

a particular treatment or intervention could benefit a patient with a very rareclinical condition

5.0.3 An inappropriate IFR is where:

a request represents a service development and therefore needs to be triagedinto the appropriate population decision making group

a request where no information is submitted in support of the individual’sexceptionality

the request is for a service or procedure that is commissioned by anotherorganisation where funding is not the responsibility of a South London CCG

5.0.4 Exceptionality:

An unusual clinical circumstance about the patient that suggests that they are:o Significantly different from the general population of patients with the

condition in question; ando Likely to gain significantly more benefit from the intervention than might be

normally expected for the average patient with the condition.The fact that a treatment is likely to be efficacious for a patient is not, in itself a basisfor exceptionality

5.0.5 Rarity:In the case of a rare indication, the Panel will assess the incidence and prevalence.This assessment will be made using published epidemiological research and alsotaking into account other similar requests received.

6 The IFR Process

See Appendix A for an overview of the IFR Process

6.1 Submitting an IFR

6.1.1 IFR and ECI applications must be submitted on a current application form.

6.1.2 The application must be sent to the CSU administration team by secure email or bypost and may be submitted by a NHS clinician including a GP, Consultant or anequivalent autonomous practitioner who is responsible for administering thetreatment

6.1.3 Patients may not submit applications directly as these are made by the clinicianresponsible for treatment. Should a patient wish to explain why they believe theircircumstances are exceptional they may put this in in writing and this informationshould be submitted with the IFR application.

6.1.4 It is the responsibility of the clinician administering the treatment /intervention tocomplete the IFR application form and to submit all relevant clinical information andsupporting evidence needed for the consideration of the application


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6.2 Patient Consent

6.2.1 Gaining Patient Consent - It is the responsibility of the requesting clinician to:

Discuss the IFR process in full with the patient Ensure that the patient gives consent for an IFR to be submitted on their behalf Ensure that the patient understands the local IFR Policy, including the timelines

for decision making; The patient should be given an IFR information leaflet and this should be

documented Advise the patient that through the submission of an application, they are giving

consent for CCG, CSU and Public Health staff members to contact/discuss theirsituation with appropriate clinicians and relevant NHS staff and this will includeaccess to patient identifiable information (PID).

Ensure that the patient signs the application form to indicate that consent hasbeen given.

6.2.3 Where an adult patient lacks the mental capacity to give or withhold consent, anyapplication should take into account the legal position regarding consentwww.doh.gov.uk/consent.

6.2.4 Consent for children should be in line with the Children’s Act, Mental Capacity Actand Mental health legislation.

Children and young people should be involved as much as possible in decisionsabout their care, even when they are not able to make decisions on their own.[1]

When obtaining consent, the doctor must establish whether the child is legallycompetent (in legal terms, 'have capacity' to give consent).

All people aged 16 and over are presumed in law to have the capacity to consentto treatment unless there is evidence to the contrary.

If the child is deemed not legally competent, consent will need to be obtainedfrom someone with parental responsibility,

The legal position differs, depending on whether the young person is aged overor under 16

6.3 Anonymity & Confidentiality

6.3.1 The application form has been designed so that all the personal and confidentialinformation about the patient, and the clinician, are provided on the first page (SectionA)

6.3.2 Anonymity is essential for two reasons:

In order to protect patient’s identity, for this reason the requesting clinician isasked to not refer to the patient by name or initials within the rest of theapplication form.

For equity of decision making, to ensure that the panel decisions do not takeinto account personal details such as age or sex

6.3.3 Depending upon individual clinical circumstances the panel may consider itnecessary to re-introduce information on the patient’s age and/or sex forconsideration by the IFR panel. (This may be relevant to some drug requests and


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requests where the policy includes an age threshold or where the natural history of acondition varies with age or sex.)

6.3.4 While maintaining the confidentiality of patients is of paramount importance, theidentity of the requesting GP should not be included in panel pack information. Giventhe size of South London’s population it is statistically unlikely that members of an IFRpanel will be personally acquainted with the patients involved. However, thecommunity of clinicians and staff post-holders is much smaller, and it is desirable tominimise any potential for bias arising from personal acquaintance or past interaction,and hence the details of the requesting GP are removed.

6.4 Evidence Base

6.4.1 The decision making process will follow the ethical decision making framework andthe IFR panel will consider the nature and extent of the evidence base for atreatment. The panel will use nationally commissioned independent MedicinesInformation services, available assessments or local independent evidenceappraisals in line with the accepted hierarchy of evidence.

6.4.2 Public Health advice, including the population implications and evidence base ofapplications will be provided by a Public Health representative

6.5 Correspondence and Communications

6.5.1 The CSU IFR team will ensure that after acknowledging receipt of the application thatthe applicant and the patient’s GP (unless the patient specifically requests otherwise)is kept fully informed of the progress of the application

6.5.2 The CSU IFR team will liaise with the applicants to ensure patients are fully informedand where appropriate supported. This will be facilitated by a patient informationleaflet.

6.5.3 If the patient is above the age of 16, the IFR team will normally copy the patient intocorrespondence concerning progress and outcome of their application.

6.5.4 If it is not appropriate, or if the patient / parent / legal guardian/ carer has indicatedthat they do not want, to receive any correspondence or to be contacted, therequesting clinician must indicate this on this on the application form.

6.5.5 The CSU IFR team will communicate decisions to the applicant, patient’s GP (unlessthe patient specifically requests otherwise) and patient by letter or email. In the eventof funding being refused this communication will include details of the appealprocess.

6.5.6 The CSU IFR team will communicate decisions to close cases to the applicant,patient’s GP (unless the patient specifically requests otherwise) and the patient byletter or email.

6.6 Photographic Evidence

6.6.1 Photographs will be treated in the same manner as all other submitteddocumentation with written patient identifiable information removed before theimages are viewed at triage or IFR Panel.


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6.6.2 Photographic evidence should only be submitted by/via the clinician and with thepatient’s consent. The clinician is responsible for informing the patient that theevidence may be viewed by the IFR Panel members. For this reason, facial featuresor other identifiable features will not be removed or blacked out of photos.

6.6.3 Where photographs are submitted that are not medical photographs the cliniciansubmitting them must ensure that quality of photography is such that the panelmembers can identify the relevant features.

6.6.4 Photographs to support applications will not be emailed to panel members orincluded in hard copy panel packs. Photographs should be brought to the panel bythe administrator and should be available for panel members to view when the casethat they refer to is being discussed. The administrator must be considered as thecustodian of photographs and should ensure that they are returned to him/her afterthe case has been discussed and placed in a sealed envelope. The panel agendashould indicate that there are photos to support the application so that members areaware when the case is being considered that there is photographic evidence.

6.7 Urgent Applications

6.7.1 If an application is marked as urgent and there is a clear clinical reason that thepatient’s health will be compromised by waiting until the next scheduled IFR panelmeeting for a decision to be made the application can be processed through theUrgent Application Route. It is expected that only a small minority of IFRs will beurgent and these will usually involve life-threatening conditions.

6.7.2 The decision to treat in the event of immediate or life-threatening circumstances mustbe made in accordance with NHS Approved Provider (Trust) governancemechanisms and the Trust’s Duty of Care towards the patient. However, treatingwithout IFR funding approval will be at the Trust’s own financial risk.

6.7.3 In order to ensure that a decision can be made quickly an urgent application may beconsidered by a specially convened group (See also 4.4.4)

6.7.4 The group considering an urgent case will usually confer either by telephoneconference or in person however in special circumstances when this is not possiblethis will be done via email.

6.7.5 The decision making process for urgent IFRs will follow the ethical decision makingframework and will consider the nature and extent of the evidence base for atreatment. This will be fully documented and reported at the next full IFR Panelmeeting for ratification.

6.7.6 Decision timeframes and deadlines for urgent cases are as per the CCG’s IFROperating Procedures and terms of Reference. Appendices XXX and XXX

6.8 Clinical Triage

6.8.1 The triage meeting must be clinically led the purpose of the Triage Meeting is todetermine that the IFR is eligible for consideration by the IFR Panel. The team willreference the following questions:

Is the treatment requested funded within an existing commissioning policy? Is the treatment requested covered by another CCG policy or process?


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Is the treatment an obvious Service Development (i.e. a request pertaining to acohort of patients and not reflective of an individual’s clinical circumstances)?

Is the submission lacking sufficient information to support the individual’s clinicalexceptionality?

Is an additional evidence review required? (see section 6.4 Evidence Base) Is the request an appeal or resubmission of a previous case?

6.8.2 Triage has the authority to close cases when further information has not beenreceived in the given timescales or a repeat application containing no new oradditional information has been received. All case closures are reported to the IFRPanel.

6.8.3 Triage has the authority to make decisions to approve or decline funding for EffectiveCommissioning Initiative (ECI) cases in South West London, assessing submissionsagainst ECI criteria and to approve or to decline funding for procedures included inthe Treatment Access Policy (TAP) in South East London assessing submissionsagainst TAP criteria.

6.9 The IFR Panel

6.9.1 The IFR panel will be multi-disciplinary with membership and quoracy in line with theterms of reference for the IFR panel.

6.9.2 Requesting clinicians or patients will not be invited to attend the IFR panel. Howeverpatients may submit additional information in writing for consideration. Anyinformation submitted by a patient will be given due respect by the Panel. Forguidance on complaints and the appeal process, see relevant sections of this policy.

6.9.3 CCGs may work collaboratively to form joint IFR panels.

6.9.4 Where joint panels are established each CCG must agree the governance of thepanel and in particular ensure that there is a clear policy regarding delegateddecision making.

6.9.5 Consideration of applications for drugs require the presence of a pharmacist on thepanel both as a presenter of the drug case and as a decision maker

6.9.6 Pharmacists and Public Health representatives will be asked to conduct evidencereviews to enable fully informed decisions to be made by the IFR panel (see section6.4 Evidence Base).

6.9.7 Decisions made will follow the ethical decision making framework and will considerthe nature and extent of the evidence base for a treatment. Clinical circumstances,defines the clinical features or progression of the named patient’s medical conditionas opposed to the patient’s social or personal circumstances.

6.9.8 CCGs have to be mindful of the clinical consequences of any financial decisions, anda decision to fund an IFR has the potential to result in direct displacement of anotherservice.

6.9.9 All panel members must declare any known conflict of interest prior to thecommencement of the meeting.


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6.9.10 Should any of the cases being discussed relate to a panel member the administratorshould bring this to the attention of the chair.

6.9.11 Should the chair have a known conflict of interest in any of the cases beingdiscussed he/she must withdraw from discussions of those cases and an alternatechair nominated for the discussion.

6.9.12 In working towards a decision, the Chair will test whether there is a consensus withinthe meeting. If there is a difference of views, funding decisions shall be determinedby a majority of the votes of members present and voting on the request. In the caseof an equal vote, the Chair shall have the casting vote.

6.9.13 The IFR panel may make the following decisions:- funding refused- funding approved without conditions- funding approved with conditions- deferred pending further information

6.9.14 Funding may be approved for an initial course of treatment with further fundingconditional upon the patient’s response. The submission to the Panel of a reportdetailing the response observed after the initial course of treatment would berequired for further consideration to be given to the submission.

6.9.15 All discussions taking place during a panel meeting are confidential. Cases may notbe discussed outside the panel meeting except with the explicit agreement of thechair.

7 Appeals Process

7.0.1 The IFR Appeal process enables applicants to appeal against the decision made bythe IFR Panel.

7.0.2 The focus of the Appeals Panel is the process that the IFR Panel used to reach adecision and not the decision itself. Applicants or patients wishing to complain aboutthe decision itself should contact the relevant PALS team for advice or complaintsteam to make a formal complaint.

7.0.3 Appeal requests must be submitted in writing to the relevant SL IFR AdministrativeTeam within 30 days of the date of the decision letter to decline funding.

7.0.4 Appeal requests must be made by a clinician on behalf of the patient.

7.0.5 Supporting statements from the patient and third parties can be submitted toaccompany the request for consideration as part of the appeal, but no new evidencecan be submitted. If new evidence is provided following a decision to decline funding,the correct procedure is to resubmit a request for reconsideration as an IFR.

7.0.6 The appeal request must indicate the applicant’s grounds for appeal. There are 3grounds for appeal that can be considered: Illegality: the refusal of the request was not an option that could lawfully have

been taken by the IFR panel. Procedural impropriety: There were substantial and/or serious procedural errors

in the way in which the IFR Process was conducted.


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Irrationality: Whether the decision was irrational in light of the informationavailable to the Panel.

7.0.7 The Triage Panel will undertake a preliminary assessment of an appeal requestassessing the submission against the grounds for appeal criteria listed above.

7.0.8 All IFR Appeal Panel members must be independent of any of the original decisionmaking processes and not have been a member of the IFR Panel involved in theoriginal decision.

7.0.9 The Appeal panel may make the following decisions:- IFR panel decision upheld- The case must be returned to the IFR panel for re consideration (see also 4.3.8)

7.0.10 When a decision is not upheld by the Appeal Panel, it will be returned to the IFRpanel for reconsideration with the minutes from the Appeal Panel meeting detailingthe grounds for the successful appeal.

7.0.11 When a decision is upheld by the appeal panel the appellant will be advised that ifthey wish to take the matter further this must be done through the NHS complaintsprocess

7.0.12 Applicants or patients who wish to complain about IFR decisions should contact therelevant complaints team to submit a formal complaint. Applicants/patients should notuse the IFR Appeal process to make a complaint about an IFR decision. The IFRappeal process is solely for the purpose of appealing against the IFR decision-making process.

8 Commissioning Process

8.1 Service Developments

8.1.1 A Service Development is defined as a request pertaining to a cohort of patients andnot reflective of an individual’s clinical circumstances. The IFR Panel is not theappropriate route for service developments. These requests should go through theappropriate procedures within the requesting Trust in the first instance (see also5.0.3).

8.1.2 If during the triage stage, a requested treatment is identified as a possible servicedevelopment, the IFR Team will notify the applicant and the relevant commissioners.

8.1.3 Any drug service developments should go through the CCG’s New Drugs Processand in SEL through the SEL Area Prescribing Committee. CCGs should develop acommissioning route for processing non-drug service developments.

8.2 Local decision-making (outside the IFR remit)

8.2.1 Where there is a clinical need for treatment but, due to a lack of exceptionality, theIFR process is not the correct funding approval route, CCGs may make a localdecision to fund treatment for a cohort of patients.


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9 Monitoring Compliance

9.1 The Individual Funding Request Process will be monitored through audit on a regularbasis for consistency of decision making and application of the ethical framework andthis IFR Policy.

10 Policy Review

10. 1 The IFR Policy will be reviewed annually or in light of any changes in legislation,practice or local/national guidance.

Next review: January 2015

11 References

11.1 In constructing this policy a number of existing policy documents have been referredto, including:

NHS Constitution 2012 ‘Interim Standard Operating Procedures: The Management of Individual Funding

Requests’ NHS England, April 2013, Ref: NHSCB/COP/02 ‘Interim Commissioning Policy: Individual Funding Requests’ NHS England, April

2013, Ref: NHSCB/CP/03 NPC Supporting rational local decision-making about medicines (and treatments)

2009 Directions to primary care trusts and NHS trusts concerning decisions about

drugs and other treatments 2009 South East London Individual Funding Requests Policy, April 2012 South West London Policy and Operating Procedures for Dealing with individual

Funding Requests, September 2011

12 Associated Documentation

South West London Effective Commissioning Initiative 2013/14 (ECI) South East London Treatment Access Policy 2013 (TAP)


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Appendix A – IFR Process Flowchart


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Appendix B – IFR Application Form

SL IFR ApplicationForm v2.1.docx

Appendix C - IFR Triage Meeting: Terms of Reference

IFR Triage Terms ofReference.docx

Appendix D – IFR Panel Terms of Reference

IFR Panel Terms ofReference.docx

Appendix E – IFR Appeal Panel Terms of Reference

IFR Appeal PanelTerms of Reference.docx

Appendix F – Ethical Decision Making Framework

EthicalDecision-Making Framework for IFRs.docx

Appendix G – Equality Analysis

Equality Analysis -IFR Policy.docx

IFR Triage Meeting Terms of Reference

Appendix CIFR Triage Meeting: Terms of Reference

1. Governance Arrangements

1.1 The Individual Funding Request (IFR) Triage meeting is a clinically led multi-professional meeting responsible for determining that an IFR application is eligible forconsideration by the IFR Panel.

1.2 The IFR Triage Meeting is accountable to the IFR Panel, so will act as a sub-committee of the IFR Panel. The IFR Panel is accountable to the ClinicalCommissioning Group (CCG) Governing Board via its committee structure.

2. The IFR Triage Process

2.1 The IFR Panel will only consider requests as defined within the CCG(s) IFR policy sothe IFR Triage process is undertaken in order to reduce inappropriate requests.

2.2 Once an application has been administratively triaged, it will be submitted to the nexttriage meeting to determine whether the IFR is eligible for consideration by the IFRpanel, from a clinical perspective.

3. Duties and Responsibilities

3.1 The purpose of the Triage Meeting is to determine that an IFR is eligible forconsideration by the IFR Panel The triage meeting will consider the following optionsfor each IFR requests:

Is the treatment requested funded within an existing commissioning policy? Is the treatment requested covered by another CCG policy or process? Is the treatment an obvious Service Development (i.e. a request pertaining to a

cohort of patients and not reflective of an individual’s clinical circumstances)? Is the submission lacking sufficient information to support the individual’s clinical

exceptionality? Is an additional evidence review required? Is the request an appeal or resubmission of a previous case?

3.2 Triage has the authority to close cases when further information has not beenreceived in the given timescales or a repeat application containing no new oradditional information has been received.

3.3 Triage has the authority to make decisions to approve or decline funding for EffectiveCommissioning Initiative (ECI) cases, accessing submissions against ECI criteria.

IFR Triage Meeting Terms of Reference

3.4 Occasionally if a decision to decline funding is made a case may be referred back tothe triage panel to recommend that a local decision is considered regarding funding

4. Reporting

4.1 The minutes of the meetings shall be recorded by the relevant IFR Manager/Officer.Triage decisions will be taken to IFR Panel for formal ratification. All case closuresare reported to the IFR Panel.

5. Membership & Quorum

5.1 IFR Triage will be made up of a multi-professional membership comprising of:

Senior Prescribing Adviser Consultant in Public Health (or their delegate) GP

5.2 The meeting will be considered quorate if one medically qualified member is present.If a drug case is to be considered, a pharmacist must be present.

6. Frequency of Triage Meetings

6.1 The frequency of triage meetings depends on volume of IFR applications received. Aminimum of one triage meeting a month is required to meet the timeline of IFRreferrals to be responded within 20 working days.

7. Confidentiality

7.1 Anonymity is essential for two reasons:



7.2 Depending upon individual clinical circumstances it may be necessary to re-introduceinformation on the patient’s age and/or sex for consideration. When cases areconsidered which require access to confidential clinical information through triage,implied consent to disclosure of such information to all members of the IFR TriagePanel will be assumed. This will be indicated to patients by the referring clinician andbe confirmed in IFR publicity material.

8. Review

8.1 The IFR Triage Meeting Terms of Reference will be reviewed annually or in light ofany changes in legislation, practice or local/national guidance.

This review February 2014

IFR Panel Terms of Reference

APPENDIX DIFR Panel: Terms of Reference


1.0.1 The Individual Funding Request (IFR) Panel is a multi-professional group responsiblefor the management of all IFRs within its remit (see section 2 below). The IFR Panelwill be responsible for approving deciding on funding for treatment requests forexceptional cases or for rare conditions.

1.0.2 The IFR Panel will be accountable to the Clinical Commissioning Group (CCG)Governing Body via its committee structure. Each CCG will be required to confirm itsgovernance arrangements to ensure that the IFR Panel is held accountable to theCCG Body.

1.0.3 Members of the IFR Panel will be appointed by the CCG’s Chief Officer. The IFRPanel will operate within the limits of delegated authority as determined by the CGG’sDirector of Finance and within the CCG’s Standing Financial Code of Practice.

1.0.4 The IFR Panel will be supported administratively by the IFR service to discharge itsresponsibilities.

1.0.5 The IFR panel will participate in the regular peer review process which will be agreedwith other IFR panels across South London.


2.0.1 The IFR Panel will consider IFR requests as defined within the South London IFRpolicy.

2.0.2 The IFR Panel have a duty to consider IFRs and make funding decisions based onthe ethical decision making framework.

2.0.3 The IFR Panel has delegated the preliminary assessment and triage of IFR requeststo a clinically led triage panel. The details of the triage process and triage panel areset out in the IFR Policy.

2.0.4 The IFR Panel will be required to consider IFRs for both high cost drugs and otherinterventions and to review decisions made for IFR submissions where newinformation is available.

2.0.5 The IFR Panel will also consider Planned Treatment Abroad if IFR Panel approval isrequired.


2.0.6 The IFR Panel will advise the CCG on the programme of care pathways and policydevelopment as they affect patients with exceptional care needs to inform futureCCG’s commissioning strategies.

2.0.7 The IFR Panel will be required to produce an Annual Report with the support fromthe IFR service.

3. Constitution

3.1 Meetings

3.1.1 The IFR Panel will adopt the consensus method of decision making where aunanimous view cannot be reached on an individual case. In the case of an equalvote, the Chair shall have a second and casting vote. At the discretion of the Chairall requests put to the vote shall be determined verbally or by a show of hands,unless the Chair directs otherwise.

3.1.2 Panel meetings will be held in private. Requesting clinicians and patients will not beinvited to attend.

3.2 Membership

3.2.1 The IFR Panel will be made up of a multi-professional membership comprising: a GP a lay representative a public health consultant delegated from the relevant CCG(s) or their delegate a head of medicines management or their delegate a senior acute commissioner (this role can be covered by the GP member in their

clinical commissioning role).

3.2.2 Other Specialist Advisors can be invited to attend by the Chair to address specificpatient issues including senior acute contracting, dental advisors, etc.

3.2.3 Members are expected to send suitable representation for the meetings they areunable to attend.

3.2.4 A register of attendance at the Panel meeting will be maintained and reviewed by thePanel on a 6 monthly basis to ensure that attendance at the panel is representativeof the membership

3.2.5 IFR Panel members are required to declare any interests before serving on an IFRPanel. Any conflicts of interest must be declared as a standing item at thecommencement of every meeting and the Chair will decide the appropriate action,including requesting that members withdraw from the meeting.

3.3 Chair

3.3.1 The Panel can be chaired by any of the members provided that s/he has sat as anIFR Panel member at least 4 times. The Chair must be identified in advance of themeeting, and must be available to approve the minutes/letters and fulfil and any otherobligations within the specified time frame.


3.4 Quorum Arrangements

3.4.1 At least 3 members of the Panel must be present for IFR Panel to proceed. 2 must be clinically qualified At least 1 medically qualified.

3.4.2 Where CCGs have chosen to have joint Panel arrangements, each constituent CCGmust have a minimum of 1 representative if there is an IFR case being discussed fora patient belonging to that respective CCG. In the event that no IFR cases are beingdiscussed for a particular CCG, an IFR Panel representative from that respectiveCCG is not required to attend but may attend to ensure quoracy of members.

3.5 Training of IFR Panel Members

3.5.1 Members of the IFR Panel will be provided with training and must be fully familiarwith the IFR Policy and Ethical Decision Making Framework for dealing with IFRs andprocess before sitting on a panel. Good practice suggest that Panel members shouldattend a training session at least once every 2 years and partake in IFR Panelsregularly to retain their specialist expertise and knowledge.

3.6 Frequency of Meetings

3.6.1 IFR Panels shall be held as required in order to ensure that there is a timelyresponse to all funding requests, but within a maximum of four weeks of a completedIFR request being made. Good practice suggests that the IFR Panel meets at leastonce a month. However changes to this arrangement may be made in order to coverannual leave or other absence.

3.7 Urgent Decisions

3.7.1 In clinically urgent situations a request may be considered in advance of a formal IFRPanel meeting. An urgent IFR will be considered by a specially convened groupacting as a sub-committee of the next scheduled IFR panel under delegated powers.The group will comprise of at least 3 members of the IFR panel membership andmust include the following:

2 must be clinically qualified At least 1 medically qualified.

3.7.2 The decision will be reported at the next IFR Panel meeting and formally ratified.

3.8 Reporting

3.8.1 The minutes of the meetings shall be recorded by the relevant IFR Manager/Officerand approved by the Chair of the Panel.

3.9 Venues of Meetings

3.9.1 The Chair of the IFR Panel will determine the venue of meetings in discussion withthe members of IFR Panel.


3.10 Joint IFR Panels

3.10.1 Some CCGs may choose to have joint Panel arrangements. The Chief Officer of theCCG will determine whether Joint IFR Panels are an effective means of executingthe IFR Panels responsibilities. See paragraph 3.4.2 for quoracy of joint Panel.

4. Confidentiality

4.0.1 Anonymity is essential for two reasons:



4.0.2 Depending upon individual clinical circumstances it may be necessary to re-introduceinformation on the patient’s age and/or sex for consideration. When cases areconsidered which require access to confidential clinical information through triage,implied consent to disclosure of such information to all members of the IFR Panel willbe assumed. This will be indicated to patients by the referring clinician and beconfirmed in IFR publicity material.

5. Review

5.0.1 The IFR Panel’s Terms of Reference will be reviewed annually or in light of anychanges in legislation, practice or local/national guidance.


IFR Appeal Panel Terms of Reference

Appendix EIFR Appeal Panel: Terms of Reference


1.0.1 The IFR Appeals Panel will be accountable to the Clinical Commissioning Group(CCG) Governing Body via its committee structure. Each CCG will be required toconfirm its governance arrangements to ensure that the IFR Appeals Panel is heldaccountable to the CCG Governing Body.

1.0.2 Members of the IFR Appeals Panel will be appointed by the CCG’s Chief Officer.

1.0.3 The IFR Appeals Panel will be supported to discharge its responsibilitiesadministratively by the IFR service


2.0.1 On behalf of the CCG, the IFR service will receive and acknowledge the letter ofappeal. The IFR triage meeting will be responsible for undertaking the preliminaryassessment of the appeal request to determine whether new evidence has beenreceived and if the case should be sent back to panel. If no new evidence has beenreceived, the case should be passed to an IFR Appeal Panel.

2.0.2 Where it is decided to convene a Panel, members of the Appeals Panel should beprovided with full details of the case including all correspondence, evidence of clinicaland cost effectiveness, full documentation of the discussion and outcome.

2.0.3 The Appeals Panel will need to consider whether there are grounds for appeal:

Illegality: the refusal of the request was not an option that could lawfullyhave been taken by the IFR panel.

Procedural impropriety: There were substantial and/or serious proceduralerrors in the way in which the IFR Process was conducted.

Irrationality: Whether the decision was irrational in light of the informationavailable to the Panel.

2.0.4 An IFR Appeal Panel will not consider new evidence. New evidence must beconsidered as an IFR resubmission.

2.0.5 If the Appeal Panel upholds the original IFR Panel’s decision, the appellant will beadvised that if they wish to take the matter further this must be done through the NHSComplaints process.


2.0.6 If the Appeals Panel consider that the IFR panel did not consider all the evidenceprovided the application can be directed back to the IFR panel for re-consideration

3. Constitution

3.1 Meetings

3.1.1 IFR Appeal Panel meetings will be held in private. Patients and their representativeswill not be permitted to attend the panel discussions to put forward their caseverbally. All appeal cases must be submitted in writing to the Panel.

3.1.2 The IFR Appeal Panel will adopt the consensus method of decision making where aunanimous view cannot be reached on an individual case. In the case of an equalvote, the Chair shall have a second and casting vote.

3.2 Membership

3.2.1 IFR Appeal Panel will include the following members:

A clinician/GP A representative of the Constituent CCG(s) Lay Member

3.2.2 All IFR Appeal Panel members must be independent of any of the original decisionmaking processes and not have been a member of the IFR Panel involved in theoriginal decision. The member must have received appropriate training (see section3.4) and must be familiar with all relevant policies and procedures.

3.2.3 IFR Appeal Panel members are required to declare their interests before serving onan IFR Appeal Panel. Any conflicts of interest must be declared as a standing item atthe commencement of every meeting and the Chair will decide the appropriateaction, including requesting that members withdraw from the meeting.

3.3 Chair

3.3.1 Any member of the Appeal Panel may chair the meeting provided that s/he hasreceived appropriate training.

3.3.2 The Chair must be identified in advance of the meeting, and must be available toapprove the minutes and relevant correspondence and fulfil and any other obligationswithin the specified time frame.

3.4 Training

3.4.1 IFR Appeal Panel members must have attended training to ensure that they are fullyfamiliar with the IFR Policy and National guidance for dealing with IFRs and processbefore sitting on the IFR Appeals panel. Best practice suggests that Appeal PanelMembers should attend a training session at least once every 2 years to retain theirspecialist expertise and knowledge.


3.5 Frequency of Appeals Panels

3.5.1 The numbers of appeals that may be received are difficult to predict and thereforearrangements for Appeal Panel meetings will be flexible, and will be arranged toensure that appeals are considered within 20 working days of an appeal beingreceived by IFR Team.

3.5.2 If a matter is exceptionally urgent the Chair shall have the power to call an IFRAppeal Panel at any other time.

3.6 Quorum Arrangements

3.6.1 The IFR Appeal Panel may not proceed unless at least two members are present,including the Chair.

3.7 Joint IFR Appeals Panels

3.7.1 Some CCGs may choose to have joint Appeal Panel arrangements. The Chief Officerof the CCG will determine whether Joint IFR Appeal Panels are an effective means ofexecuting the IFR Panels responsibilities.

3.8 Reporting

3.8.1 The minutes of the meetings shall be recorded by the relevant IFR Manager/Officerand approved by the Chair of the Appeal Panel.

3.8.2 Copies of minutes will not be distributed to IFR Appeals panel members for theirretention and will not be placed in the public domain in order to preserve patientconfidentiality.

4. Confidentiality

4.1 Anonymity is essential for two reasons:



4.2 Depending upon individual clinical circumstances it may be necessary to re-introduceinformation on the patient’s age and/or sex for consideration. When cases areconsidered which require access to confidential clinical information through triage,implied consent to disclosure of such information to all members of the IFR AppealPanel will be assumed. This will be indicated to patients by the referring clinician andbe confirmed in IFR publicity material.

5. Review

5.0.1 The IFR Appeal Panel’s Terms of Reference will be reviewed annually or in light ofany changes in legislation, practice or local/national guidance.


Ethical Decision Making Framework for IFRs v1.1

Ethical Decision-Making Framework for Individual Funding Requests(IFRs) v1.1

1. Introduction

1.1 This Ethical Framework sets out the values that South London IFR Panels and SouthLondon CCGs will apply in making decisions on IFRs. South London CCGs will use it in alldecisions, ranging from those which may affect a cohort of patients reviewed at the IFRTriage meeting to those that affect individuals heard at IFR Panels. This framework shouldbe used in conjunction with the South London IFR Policy for dealing with IFRs

2. Purpose of the Ethical Framework

2.1 Public bodies are required to be transparent about their decision- making processes,accountable to their service users and should be able to demonstrate that these arereasonable. South London CCGs have to demonstrate that their decisions about healthpolicies and IFRs are based on sound principles and have been made after carefulconsideration of all the relevant factors, with reference to local conditions, and with aconscious intent to avoid discrimination.

2.2 CCG’s have to take difficult and sensitive decisions about what will be funded and what willnot. The way in which decisions are made is fundamental to their democratic acceptabilityand contributes to whether a decision is judged as fair.

2.3 This framework is designed to provide guidance to decision makers to help them make fairand consistent decisions which respect the needs of individuals and the community.

2.4 The purpose of an ethical framework is to:

to demonstrate that decisions about health policies and IFRs are based on soundprinciples and have been made after careful consideration of all the relevant factors,with reference to local conditions, and with a conscious intent to avoid discrimination

Provide a coherent structure and framework for decision-making that ensures all theimportant aspects of each issue are considered.

Promote fairness and consistency in decision-making Ensure that the reasons behind decisions that have been taken are clear and

comprehensive. Provide transparency and support CCG to

3. Legal Duties

3.1 South London CCGs have certain legal duties as public bodies and their decisions andactions should be able to withstand scrutiny with regards to:


Meeting statutory duties Legality Reasonableness Proportionality Procedural Propriety Legitimate expectations Equality and non-discrimination

4. Equality Statement

4.1 South London CCGs and the SLCSU have a duty to have regard to reduce healthinequalities in access to health services and health outcomes achieved as enshrined in theHealth and Social Care Act 2012.

4.2 South London CCGs and the SLCSU are committed to ensuring equality of access andnon-discrimination, irrespective of age, gender, disability (including learning disability),gender reassignment, marriage and civil partnership, pregnancy and maternity, race,religion or belief, sex (gender) or sexual orientation. In carrying out their functions, SouthLondon CCGs and the SLCSU will have due regard to the different needs of protectedequality groups, in line with the Equality Act 2010.

4.3 This document is compliant with the NHS Constitution and the Human Rights Act 1998.This applies to all activities for which they are responsible, including policy development,review and implementation.

5. Five core principles for decision-making

5.1 In line with the legal and ethical duties to CCG populations, it is expected that the followingkey principles will be applied to all decisions.

5.2 These key principles are the need for decisions to be rational; socially inclusive; clear and open to scrutiny; take economic factor into account , and themselves must promote health for both individuals and the community

Principle 1: Rational

5.3 South London CCGs have a responsibility to make rational decisions and to act fairly inbalancing competing claims on resources between different patient groups and individuals.

5.4 Aspects of this principle include: Ensuring that the decision is based on evidence of clinical effectiveness


Being logical in reasoning towards a decision Making a realistic appraisal of the likely benefit to patients Weighing up all the relevant factors, including risks and costs Taking into account the wider political, legal and policy context Ensuring individuals involved in decision making are appropriately trained

5.5 Where available, existing national standards, policy and authoritative guidelines must beconsidered; such as national directives, guidance from the National Institute of Health &Clinical Excellence, Department of Health directives etc. Local factors, including existingprovisions must also be considered. Decisions should be taken within the political and legalcontext.

5.6 South London CCGs are committed to evidence-based healthcare. Decisions shouldtherefore be made on the basis of a reasonable evaluation of the available evidence ofclinical effectiveness. Those involved in decision-making have an obligation to seek out thebest evidence of clinical effectiveness to inform their decisions.

5.7 The approach to accessing the validity and credibility of evidence should be broad butmaintain high standards of critical appraisal. South London CCGs will follow the well-developed scientific approach to hierarchy of evidence. Where appropriate, both qualitativeand quantitative evidence will be taken into consideration.

5.8 Outcome measures should be considered in terms of their importance to the patients. Thisis particularity significant in the treatment of illness where no cure can be expected, inpalliative care, and the care of people who are terminally ill. Rational decisions will weighup likely outcomes, the wider contexts in which treatments can be provided, theimplications for service delivery, clinical pathways, and the scale and nature of benefits,costs and risks.

5.9 The position, qualifications and skills of decision makers will be appropriate to ensure duedeliberation of all the relevant factors.

Principle 2: Inclusive

5.10 The term inclusivity may be interpreted as including: Reinforcing the concept of equal opportunity of access to health care. Ensuring patient and public engagement in decision-making. Balancing the rights of individuals with the rights of the wider community to achieve

equitable and consistent resource allocation between individuals and groups in society.

5.11 There are proven links between social inequalities and inequalities in health, health needsand access to healthcare. Access to funding of services should be governed, as far aspracticable, by the principle of equal access for equal clinical need. Individual patients orgroups should not be unjustifiably advantaged or disadvantaged on the basis of age,gender, sexuality, race, religion, lifestyle, occupation, social position, financial status, familystatus (including responsibility for dependants), intellectual / cognitive function or physicalfunctions.


5.12 Effort should be made to ensure broad based participation in decision-making groups andcommittees. Decision-making should be non-partisan and individuals will need to be able totake an objective view of the topic, and maintain an open mind about the evidence. As faras possible consensus decision-making will be used.

5.13 Decision-making should not discriminate on characteristics which are irrelevant to healthconditions and the efficacy of treatment. Consideration of factors such as age and ethnicitywill only be considered where this is clinically relevant.

5.14 Decisions should take account of local and societal sensitivities.

5.15 There should be an active attempt to engage patients, carers and the wider public in thedecision-making process to ensure that the perspectives of both health care providers andconsumers are fully taken into account.

5.16 The aim is to achieve consistent and equitable opportunity of access to health care,between individuals and groups in society, and to avoid the kind of arbitrary discriminationsometimes referred to with the term ‘postcode’ as in ‘postcode lottery’ (of health serviceprovision).

5.17 Policies should work in favour of patient choice at the individual level, respecting theindividual’s preferences, in particular, the ethical framework calls for sensitivity to thepatient’s perspective and the individual nature of choices based on quality of life.

5.18 South London CCGs will respect patient choice about where an IFR treatment, if agreed tobe funded, is delivered, as far as this is compatible with IFR Panel’s judgments as to theclinical and cost effectiveness, against costs quoted that were presented for their decisionmaking, and having regard to whether proposed providers have been commissioned by theNHS for the treatments in question.

Principle 3: Clarity, consistency and transparency

5.19 The values and principles at all levels of decision-making must be consistent. IFR decisionsand the way they are determined, will be clearly specified, consistent, easy to understand,and open to public scrutiny.

5.20 This should also be the case with the roles and responsibilities of individual’s involved inthe process, accountabilities, governance arrangements, and the patient’s right of appeal.

5.21 The formal process set out for the identification, prioritisation and review of policy issueshas been designed with the need for clarity and scrutiny. However, IFR Panel membersundertaking decision-making have a responsibility to work towards achieving these goals.Decision makers will provide the rationale for their decisions; and all facts that haveinfluenced a decision will be clearly stated in the records of meetings.

5.22 The process of decision-taking will also be carefully documented, to show that it hasconformed to the agreed process and to record consensus. Communication throughout a


decision-making process is required to be clear and effective and communication aboutdecisions need to be unambiguous and articulate.

Principle 4: Taking into account economic factors

5.23 South London CCGs must ensure that the decisions they take demonstrate value formoney and an appropriate use of NHS funding based on the needs of the population itserves. Given the finite resources available to CCG’s, their budgets must be managedresponsibly so the cost of an intervention must be considered alongside the evidence ofeffectiveness.

5.24 Investing in one area of healthcare inevitably diverts resources from other areas. Decisionswill be based on careful consideration of the trade-offs between costs and benefits, both inthe short and longer term, but also recognise that complex trade-offs cannot necessarily bereduced to simple cost-benefit calculations.

5.25 South London CCGs will consider the extent to which the individual or patient group willgain a benefit from the treatment. They will also balance the needs of each individualagainst the benefit which could be gained by alternative investment possibilities to meet theneeds of the community.

South London CCGs should only invest in treatments and services which are of provencost-effectiveness unless it does so in the context of well-designed and properly conductedclinical trials that will enable the NHS to assess the effectiveness and/or value for money ofa treatment or other healthcare intervention. In general, low-cost treatments with higheffectiveness will be preferred, whereas high cost treatments with low effectiveness are tobe discouraged.

Principle 5: Promote health for both individuals and the community

5.26 Each CCG is required to identify priorities for its population, decide how healthcareresources are to be allocated, and determine the priority to be assigned to a service or aparticular health care intervention.

5.27 Decisions about the allocation of health care resources should be based on a clearunderstanding of the health needs of the population, whom decisions will affect, and thescale and nature of benefits- health needs assessment and JSNA. There is a requirementto balance the needs of the individual with the needs of the wider community.

5.28 Policies which promote health and avoid people becoming ill are considered alongsidecurative treatments and other interventions. There may be times when it is appropriate totarget some demographic groups or health issues in order to reduce inequalities andpromote the well-being of the community as a whole. Priority may be given to healthservices targeting the needs of sub-groups of the population who currently have poorerthan average health outcomes (including morbidity and mortality) or poorer access toservices.


6. Considerations

6.1 South London CCGs seek to achieve a balance between the ethical principles and to meetthe legal duties of public bodies. When making resource allocation decisions, the followingconsiderations should be taken into account:

The standard treatment options available to the patient. The clinical needs of the patient, and the nature of the intervention including the

clinician’s treatment plan The scientific evidence of clinical effectiveness of the proposed intervention and where

in doubt, normative practice The cost effectiveness of the intervention The balance of risk and benefit for the patient and the capacity to benefit The impact of provision of this treatment on South London CCG resources and whether

needs can be met with an alternative provider Consistency in decision-making and the impact of providing similar treatment to other

patients with similar needs The impact of the funding decision on other services or interventions for which money is

then not available Patient views Potential human rights considerations and proportionality Procedural propriety in decision-making, transparency and probity The legality of the funding decision

7. References

7.1 In constructing this ethical framework, a number of existing ethical policy documents havebeen referred to, including:

NHS South West London Ethical Decision Making Framework for Individual FundingRequests

NHS North West London Ethical Framework for decision-making NHS Commissioning Board Ethical Framework for priority setting and resource

allocation NHS Kent and Medway Ethical Framework NHS Brighton and Hove Ethical Framework

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EQUALITY ANALYSIS

Name of the policy being assessed:

SOUTH LONDON INDIVIDUAL FUNDING REQUESTS (IFR Policy)Name of Organisation:

South London Commissioning Support Unit for South London CCGs

Date: February 2014

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Equality Analysis ChecklistAn Equality Analysis is a review of a policy, function or service which establishes whether there is a negative effect or impact on particular social groups.In turn this enables the organisation to demonstrate it does not discriminate and, where possible, it promotes equality.

This check list is a way to help staff think carefully about the likely impact of their work on equality groups and take action to improve services andprojects for local people where it has a positive or negative impact.

Name of the policy / function / service development being assessed:South London Individual Funding Requests (IFR) Policy

Briefly describe its aims and objectives: This policy sets out the principles by which South London CCGs willmake individual funding decisions. The policy should be read inconjunction with the IFR Panel Terms of Reference, OperatingProcedures and Ethical Decision Making Framework.

Directorate lead: CCG Chief Officer

Is the Equality statement situated in the first three sections of thedocument? If no, you may wish to use the Equality statement below Yes

Equality Statement:“This document demonstrates the organisation’s commitment to create a positive culture of respect for all individuals, including staff, patients, theirfamilies and carers as well as community partners. The intention is, as required by the Equality Act 2010, to identify, remove or minimise discriminatorypractice in the nine named protected characteristics of age, disability, sex, gender reassignment, pregnancy and maternity, race, sexual orientation,religion or belief, and marriage and civil partnership. It is also intended to use the Human Rights Act 1998 and to promote positive practice and value thediversity of all individuals and communities”.

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Development of the PolicyThe South London Individual Funding Requests (IFR) Policy has been developed with input from representatives from each of the Clinical CommissioningGroups (CCGs) in South London and coordinated by the IFR Team in South London Commissioning Support Unit (CSU).

1. Equality Group 2. What evidence hasbeen used for thisanalysis?

3. What engagementand consultation hasbeen used

4. Identify positive andnegative impacts

5. How are you goingto address issuesidentified?

6. Lead andTimeframe

AgeThink about different agegroups and think about thepolicy / function / service andthe way the user would access,is it user friendly for that age?

Age data monitoredwithin equalitymonitoring section of IFRsubmission.

Anonymisation:IFRs anonymised beforereview by decision-makers as per policy. Agereintroduced only ifcentral to CCG policyand/or necessary forclinical reasoning fordecision-making.

Where age is consideredas part of the decision,decision-makers operatewithin CCG policy andapply ethical framework.

Ethical Framework:Decision-making appliesethical framework and

CCGs engaged andconsulted includingrelevant stakeholders:Public Health, GPs, LayPanel Members,Pharmacists andCommissioning.

Patient involvementreviewing relevantappendices to policy(patient leaflet)

Negative Impact

Policies and ethicalframework applied indecision-making toreduce negative impact.However, access to someprocedures in the TAPand ECI policies arerestricted by age, this isboth with lower age limits(for cosmetic procedures)and upper age limits e.g.for grommets whilstassisted conceptionprocedures have lowerand upper age limits forfunding. These agerestrictions are evidencebased and supported byclinical evidence ofeffectiveness, butapplicants may still applyfor funding due to

Monitored by includingEquality Monitoringsection within IFRApplication form .Dataanalysed quarterly toensure that there is aconsistency reflected inthe age profile ofapplications andapproved funding.

CCG Policies reviewedensuring relevantstakeholderengagement andconsultation

On-going.

IFR team tomonitor andreport to CCGsquarterly

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principles of non-discrimination, inparticular the ‘Inclusive’principle.

IFR Training:Panel members attendappropriate trainingcovering implementationof ethical decision-makingframework

exceptionality even if agecriteria are not metprocedures.

DisabilityThink outside the box, you maynot be able to see the disability.It could be physical (hearing,seeing) or a learning disability(Autism).

Accessibility – venue,location, signage,furniture, gettingaround

Disability awarenesstraining for staff

Actively involve theservice user and talk itthrough with them

Disability data monitoredwithin equalitymonitoring section of IFRsubmission.

Reasonable Adjustments:CCGs will makeadjustments as may berequired to ensure thatthis policy does notadversely affect anygroup of people.

Ethical Framework:Decision-making appliesethical framework andprinciples of non-



Positive Impact Monitored by includingEquality Monitoringsection within IFRApplication form.

Data analysed quarterlyto ensure that there is aconsistency reflected inthe disability profile ofapplications andapproved funding andno negative impact.

The CCG will makeadjustments as maybe required to ensurethat this policy does

On-going


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discrimination, inparticular the ‘Inclusive’principle.


not adversely affectany group of people

Gender ReassignmentThink about creating anenvironment within the service/ policy or function that is userfriendly and non-judgemental.

If the policy / function / serviceare specifically targeting thisprotected characteristic, thinkcarefully about training,confidentiality andcommunication skills.

Gender reassignmentdata monitored withinequality monitoringsection of IFR submission.

IFR cases for cosmeticprocedures for genderreassignments patientsconsidered by IFR Panel.

Anonymisation:IFRs anonymised beforereview by decision-makers as per policy.

Ethical Framework:Decision-making appliesethical framework and



Positive Impact

Gender reassignedpeople are treated in thesame way as the genderto which they havetransitioned with regardsto some cosmeticrequests e.g. MTF forbreast enlargement butare treated differently(positively) with regardsto other requests (forexample hair removal forMTF).

For other applicationswhich would not be

Monitored by includingEquality Monitoringsection within IFRApplication form

Data analysed quarterlyto ensure that there is aconsistency reflected inthe number ofapplications fromgender reassignedpeople and the numberof applicationsapproved for fundingand that there is nonegative impact.

On-going


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principles of non-discrimination, inparticular the ‘Inclusive’principle.


affected by gender ,gender reassigned peopleshould be treatedequitably with allapplicants

Marriage and Civil PartnershipThink about access andconfidentiality, the partner maynot be aware of involvement oraccess to the service.

Staff training.


Where relationship statusis considered as part of aCCG policy decision,decision-makers operatewithin CCG policy andapply ethical frameworkand do not discriminatewithin a relationship as towhether a couple aremarried or have a CivilPartnership.



Neutral Impact

Policies and ethicalframework applied indecision-making toreduce negative impact.

All patients are askedwhether correspondenceshould be copied to themwith the option to declinein order to preserve theirconfidentiality should apartner or other familymember not be aware oftheir access to theservice.


On-going

IFR team toreport to CCGsquarterly on anyissueshighlighted forthis equalitygroup

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Ethical Framework:Decision-making appliesethical framework andprinciples of non-discrimination, inparticular the ‘Inclusive’principle.


There is no datacollected to identifythis group to enableseparate monitoring

Pregnancy and maternityThe policy / function / servicemust be accessible for all e.g.opening hours.

Are the chairs appropriate forbreast feeding, is there aprivate area? Are there babychanging facilities and is therespace for buggies?



IFR Training:



Neutral Impact The CCG will makeadjustments as maybe required to ensurethat this policy doesnot adversely affectpregnant or post natalpatients, but there isno data collected toidentify this group toenable separatemonitoring

On-going


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Panel members attendappropriate trainingcovering implementationof ethical decision-makingframework

RaceYou need to think carefullyabout the local demographicsof the population who will beaccessing the policy / function /service. Talk to public health.

Think about:

Cultural issues (gender,clothing etc)

Languages

Support to access

Staff training oncultural awareness,interpreting

Race data monitoredwithin equalitymonitoring section of IFRsubmission.

Social circumstances,such as race, are notnormally considered asgrounds for funding IFRsor ECI/TAP procedures, asper policy, in order toprevent negative andpositive discrimination.


Ethical Framework:Decision-making appliesethical framework andprinciples of non-



Positive Impact

Negative impact – due tothe diverse ethnicityprofile of South Londonand some areas of highnumbers of particularethnic groups. It isessential when looking atapplications that thepanel understand thelocal profile asexceptionality and rarityfor some geneticconditions linked toparticular ethnic groupswill not be seen to beexceptional in someLondon Boroughs wherethe CCGs should haveconsidered this withregards to theircommissioning activities

Monitored by includingEquality Monitoringsection within IFRApplication form.

Data analysed quarterlyto ensure that there is aconsistency reflected inthe racial / ethnicprofile of applicationsand approved funding.

On-going


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discrimination, inparticular the ‘Inclusive’principle.


Religion or BeliefAs above, think about localpopulation and what religion orbelief they may have.

Think about:

Staff training onrespecting differences,religious beliefs

Are you trying toimplement during atime of religiousholidays e.g. Ramadan

Is there an area forprayer times?

Religion or belief datamonitored within equalitymonitoring section of IFRsubmission.

Social circumstances,such as religion or belief,are not normallyconsidered as grounds forfunding IFRs or ECI/TAPprocedures, as per policy,in order to preventnegative and positivediscrimination.

Anonymisation:IFRs anonymised beforereview by decision-



Positive Impact

Religion and belief arenot considered whenmaking IFR decisions,however, requests whichhave a culturally sensitiveor religious aspect tothem will be treated withrespect and this aspect ofthe referral will be takeninto consideration in anyresponses to the patient,in particular anyinstructions from thepatient not to sendcorrespondence to theirhome addresses will be


Data analysed quarterlyto ensure that there is aconsistency reflected inthe religious profile ofapplications andapproved funding.

On-going


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makers as per policy.



adhered to.

SexThis is the impact on males /females.

For example same sexaccommodation, are their areasfor privacy?

Is it accessible for both takinginto account working serviceusers? Would it be a venuethey would go to?

Gender monitored withinequality monitoringsection of IFR submission.

Anonymisation:IFRs anonymised beforereview by decision-makers as per policy. Sexreintroduced only ifcentral to CCG policyand/or necessary forclinical reasoning for



Neutral impact

Policies and ethicalframework applied indecision-making toreduce negative impact.



Data analysed quarterly

On-going


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decision-making.

Where sex is consideredas part of the decision,decision-makers operatewithin CCG policy andapply ethical framework.



to ensure that there is aconsistency reflected inthe gender profile ofapplications andapproved funding.

Sexual OrientationDon’t make assumptions as thisprotected characteristic maynot be visibly obvious.

Providing an environment thatis welcoming for example visual

Sexual orientation datamonitored within equalitymonitoring section of IFRsubmission.

Anonymisation:

CCGs engaged andconsulted includingrelevant stakeholders:Public Health, GPs, LayPanel Members,Pharmacists and

Positive Impact

Ensure policies anddecisions on fertilitytreatments for same sexcouples do not


Data analysed quarterly

On-going


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aids, posters, leaflets.

Using language that respectsLGB&T people.

Staff training on how to askLGB&T people to disclose theirsexual orientation without fearor prejudice.

IFRs anonymised beforereview by decision-makers as per policy.



Commissioning.


disadvantage the couplein comparison toheterosexual couples dueto their sexuality

to ensure that there is aconsistency reflected inthe sexual orientationprofile of applicationsand approved funding.

CarersDoes your policy / function /service impact on carers? Askthem.

Do you need to think aboutvenue, timing?

What support will you beoffering?

Policy for patient consentfor IFRs takes intoaccount consent forminors and vulnerableadults,.

Reasonable Adjustment:

The CCG will makeadjustments as may berequired to ensure that


Patient involvementreviewing relevant

Neutral

Carer status cannot betaken into considerationwhen consideringapplications for IFR forcarers unless there is achange to policy forpositive discrimination.

The CCG will makeadjustments as maybe required to ensurethat this policy doesnot adversely affectany group of people

On-going


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this policy does notadversely affect anygroup of people

appendices to policy(patient leaflet)

Applicants should ensurethat their patients areaware that decisions canonly take into accountclinical and not socialneeds.

There is no datacollected to identifythis group to enableseparate monitoring

Please send to the Equality/Governance Lead for publication on website (this is a legal requirement).

Responsible Officer: _____________________________________________ Date: _______________________________

Team/Organisation: _______________________________

Equality Analysis approved by: ____________________________________ Date: _______________________________

Team / Organisation: ______________________________

Date submitted to Equality Lead: ______________________________

For Croydon CCG, Lewisham CCG and SLCSU For Merton CCG, Sutton CCG and SLCSUValerie Richards, Equality and Diversity Lead Wasia Shahain, Equality and Diversity LeadTel: 020 3049 4167 Tel: 020 8251 0510Email: [email protected] Email: [email protected]

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Screening overview

Screening completed by (please includeeveryone’s name)

Organisation Date

Amy SimpsonSouth London Commissioning Support Unit

Nicola HoweSouth London Commissioning Support Unit 6/03/2014

1

Appendix H

South London IFR Policy CCG Operating Procedures

This is to be read with the South London Individual Funding Requests (IFR) Policy and the terms of reference

(appendices C, D and E) and to provide the local operational CCG details. Section 2 will be agreed as part of the

SLA between the CSU and CCG.

Contents:

Section 1 – Governance Arrangements

Section 2 - Key Performance Indicators (KPIs)

Section 3 – deviations from IFR Policy

Section 1 - Governance Arrangements

1.1 CCG Leads

XXX CCG

Accountable Executive IFR Lead CCG Referral ManagementService or CAS?: Y/N

Name Title Name Titlee.g. Director of Commissioning

2

1.2 IFR Panel

Is there an agreed joint panel arrangement? Y/N Which CCGs are included in the joint panel?

If Yes Are there joint governance arrangement for thejoint panel? Y/N

If there are no joint governance arrangements please state the governancearrangements

1.3 IFR Panel Membership

IFR Clinical Triage Membership IFR Panel/ Appeal Membership IFR Panel Chair IFR Panel Member Traininge.g. GP Public Health Pharmacist

e.g. GP Public Health, Pharmacist Lay Member Commissioning

Name e.g. Every 2 years

Quoracy?

Eg 1 clinican

Quoracy?

Eg three members

Positione.g. Lay Member

1.4 Financial Limits

IFR Panel Funding Approval Limit CSU Invoice Approval LimitDrugs Non Drugs Drugs Non Drugse.g. £50k e.g. £50k

3

Section 2

2.1 Key Performance Indicators (KPIs) Possible examples

IFR requesttaken to IFRPanel fordecision

Urgent IFRrequests takento urgent Panelfor decision

Case closedfollowing requestfor furtherinformation fromapplicant notreceived

Appealsubmissionlimitation period

Complete appealsubmission takento IFR AppealPanel for decision

Meeting minutesapproved by Chair

Decision outcome sent to applicant

e.g. 20 workingsdays



e.g. 1 month fromdate of decisionletter

30 working days 5 working daysfollowing meeting

5 working days following meeting

2.2 Reporting Arrangements

CCG Monthly CSU KPI reportsent to nominated CCGlead:

Quarterly CSU IFR reportsent to nominated CCGlead::

e.g.XXX CCG

e.g. CCG Chief Officer e.g. CCG Chief Officer

4

Section 3. Deviations from IFR Policy

Section of Policy Deviation Reason Associated DocumentationRef Heading e.g. N/A e.g. N/A e.g. N/A

This appendix Agreed on …………………………………. (Date)

By……………………………………………………………..(Name)

Signed ……………………………………………………….

Copy sent to IFR Team …………………………………..(Date)

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