PAPER 11.0 Barnet CCG: meeting of the Governing Body 4 April 2013

PAPER 11.0
Barnet CCG: meeting of the
Governing Body 4 April 2013
2 April 2013
Title:
Individual Funding Request Policy (Interim)
Agenda item:
Action requested:
NHS Barnet CCG Governing Board to approve the repost
Timing:
Executive summary: This final draft policy sets out the decision-making process, delegated
responsibility and legal framework for managing individual funding
requests. On legal advice, the status of this policy remains as interim
given that it is being adopted at a point of significant transition.
The policy reflects the steer from the NHS Commissioning Board which
takes on responsibility for funding requests for specialised
commissioning from 1 April 2013.
Summary of
recommendations:
It is recommended that Barnet CCG:
•
•
•
Establish an IFR Panel Committee of its governing body to be
chaired by a CCG member (clinical member is suggested) that will
meet in common with other CCG committees in the POD (5 North
London CCGs) – noting that CCG members will not have voting
rights outside of their own area
Establish an IFR Appeal Panel Sub-Committee (this would be a
sub-committee of the IFR Panel Committee) it is suggested that the
chair of this Sub-Committee is a lay member
Nominate a member or manager to be responsible for signing off
triage recommendations (weekly)
Please note that the decision-making process needs to be in place for
1 April 2013. Extension granted to Barnet CCG up to 4 April 2013.
Related documents:
Date of document
completion:
14 March 2013
Document approval
history:
Previous drafts have been circulated to CCGs and presented to
meetings with chief officers.
Author name and
Anna Stewart, Director of Technical Contracting
Barnet CCG Governing Board meeting
title:
4 April 2013
Susan Beecham, Deputy Director Individual Funding Requests
Susan Aylen-Peacock, Head of Corporate Governance and Risk
Introduction
Previous iterations of the policy and accompanying briefing papers have been circulated and
discussed with CCG Chief Officers. Comments from those discussions and legal advice
provided by Capsticks have been incorporated into this draft policy and it is envisaged that there
will be further changes to reflect developments in the NHS Commissioning Board and other
comments received. As such, it is recommended that this adopted as interim policy with review
no later than September 2014. Given the fast pace of change at present, it is possible that this
draft policy may need further minor updates and require presentation to the CCG at short notice.
There have been two workshops that have provided useful input into the process: i) a public
health workshop covering North East London on 15February and ii) a standard operating
procedure workshop on 20 February. This second event was hosted by the IFR Team and
invited panel members, public health and medicines management across the breadth of the
North and East London area to review and contribute to the draft operating procedures for the
IFR service. This has both helped refine our processes and quantify the likely input required
from both public health and medicines management.
Governance
Legal advice has confirmed that in order to enable the CCGs to manage Individual Funding
Requests in line with the proposed policy the constitution of each CCG will need to be amended
to reflect:
•
•
•
•
The establishment of a committee of the Governing Body, to be known as the Individual
Funding Requests (IFR) Panel – see below
The establishment of a sub-committee of the IFR Panel, to be known as the IFR Appeals
Panel – see below
Delegation to the IFR Panel Chair (or other nominated member or manager) to
determine requests at the triage stage of the process and to take urgent action in
respect of IFR requests as necessary, with any such action being reported to the next
IFR Panel.
Note – the Scheme of Delegation will also need to be updated reflect the powers
delegated to the IFR Panel and IFR Appeals Panel
For Barnet CCG is it suggested that the following text should be inserted at 6.6.3 – committees
of the Governing Body, in the CCG’s constitution to establish the Individual Funding Requests
Panel and an Appeals Panel as set out below:
•
Individual Funding Requests Panel – the Individual Funding Requests Panel, which is
accountable to the group’s governing body, shall consider and determine individual funding
requests in line with the CCG’s agreed policy. The governing body has approved and keeps
under review the terms of reference for the Individual Funding Requests Panel, which
includes information on the membership of the Individual Funding Requests Panel.
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Barnet CCG Governing Board meeting
•
•
4 April 2013
Sub-committees of the Individual Funding Requests Panel - the Individual Funding
Requests Panel shall appoint the following sub-committees to help discharge its duties and
powers.
IFR Appeals Panel - the IFR Appeals Panel reports to the Individual Funding Requests
Panel which approves its terms of reference. Its responsibilities include consideration of
whether due process has been followed in the IFR decision-making process.
Policy Model
The outline draft policy for has been drawn from the two policies that are currently in existence
for NLC and NELC. Some sections, particularly around definition, have been drawn from the
draft policy of the NHS CB. It should be noted that in addition to these two overarching policies,
there are a number of other policies that the team follow that cover the range of different cases
that are processed by the team. There are some local variations to these, particularly in NCL.
These are summarised in the following table:
Local IFR and Related Policy Variations
CCG
IFR
Assisted
Conception
Bariatric
POLCE/V
Barnet
Local policy 2004
NICE guidance
NCL Policy Nov
2012
Camden
Local policy 2009
NICE guidance
NCL Policy Nov
2012
Local policy 2005
NICE guidance –
upper 2 weight
thresholds only
NCL Policy Nov
2012
NCL Policy Nov
2012 + local
additions
Enfield
NCL
Policy
Sept
2012
Haringey
Local policy 2010
NICE guidance –
upper 2 weight
thresholds only +
local criteria
Islington
Local policy 2008
NICE guidance
NCL Policy Nov
2012
NEL Reproductive
Medicine Network,
Eligibility criteria
for NHS-funded
IVF/ICSI. April
2008
One set of criteria
for City and
Hackney,
Newham, Tower
Hamlets, applied
from May 2011
Interim POLCV
for Waltham
Forest, City and
Hackney, Tower
Hamlets and
Newham CCGs,
November 2012
City &
Hackney
Newham
Tower
Hamlets
NELC
Policy
May
2012
Barking &
Dagenham
Havering
Redbridge
Waltham
Forest
NELC
Policy
May
2012
NEL Reproductive
Medicine Network,
Eligibility criteria
for NHS-funded
IVF/ICSI. April
2008
Above set of
criteria applied to
Barking &
Dagenham,
Havering,
Redbridge,
Waltham Forest
from 2012
Overseas Funding
DH guidance
East London and
City Alliance,
Patients seeking
NHS-funded
treatment in
Europe, Policy
and Process,
December 2010
Interim POLCV
for Barking,
Havering and
Redbridge CCGs
November 2012
Interim POLCV
for Waltham
Forest, City and
Hackney, Tower
Hamlets and
Newham CCGs,
DH guidance
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Barnet CCG Governing Board meeting
4 April 2013
November 2012
We will agree a programme of review with CCGs to update policies where needed over
2013/14.In particular it is proposed that the CSU support CCGs in reviewing their assisted
conception policies in the light of the recent NICE guidance “Assessment and treatment for
people with fertility problems”. The NICE guidance is advisory not mandatory for
commissioners. In the meantime, the IFR service will continue to work to the current local
policies.
Proposed Operating Model
The IFR Team deals with a large volume of cases, only a small proportion of which result in a
IFR panel decision. All cases coming into the service are triaged and follow the most
appropriate route for decision whether that is referral management (i.e. following POLCE/V
policy); prior approval (for example IVF) or true IFRs.
A recent snap-shot view of the proportion of cases going to IFR panel compared to the volume
of cases processed by the Team, has been extrapolated to provide a potential whole-year effect
in the table below:
Count of all cases submitted to the IFR Team September to November 2012
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Barnet CCG Governing Board meeting
4 April 2013
From 1 April 2013, the NHS Commissioning Board (NHS CB) will assume commissioning
responsibility for specialised services, including requests for individual funding. Using the same
sample case-load as above, we have estimated the proportion of cases likely to fall within the
NHS CB remit is around 30%. The following table shows how this has been calculated.
Sept – Nov 2012
Current Referrals
CCG
Total
Referrals
Pro
rata
Specialised Commissioning
Drug Bariatric Other Potential total
Pro
Rata
146
584
16
12
9
4
41
164
Camden
59
236
1
2
8
0
11
44
Enfield
106
424
5
6
8
1
20
80
Haringey
58
232
5
0
13
2
20
80
Islington
135
540
3
5
7
0
15
60
City and Hackney
70
280
7
7
4
5
23
92
Newham
79
316
5
15
6
5
31
124
Tower Hamlets
82
328
7
6
0
6
19
76
Barking and Dagenham
72
288
2
36
2
0
40
160
Havering
111
444
3
54
2
0
59
236
Redbridge
79
316
2
8
5
2
17
68
Waltham Forest
62
248
2
9
2
1
14
56
1059
4236
58
160
66
26
310
1240
Barnet
Total
Proposed scope of the CSU team
•
•
•
•
•
•
•
Management of the individual funding request process
Triage of procedures of limited clinical effectiveness/value (this is to 9 CCGs, 4 CCGs
have RMCs which carry out this function)
Triage of criteria-based funding requests (including medicines’ management tick-box
forms)
Triage of requests where local policies differ, e.g. assisted conception, where there is a
case of exceptionality for consideration.
Management of business case /service development requests arising from individual
requests (this is to be agreed)
Initial evidence searches to support the work up of individual cases (via Analytics)
Work up of clinical policies arising from the IFR for CCG approval
The IFR Team has been designed when the new commissioning architecture was known and
therefore been set up to be the right size to manage the process of requests that are outside
agreed CCG agreed commissioning arrangements, it has not been scoped to include any of the
resource that will be needed by the NHS CB to manage an IFR process for specialised
commissioning.
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Barnet CCG Governing Board meeting
4 April 2013
Post title
Directorate
Weighting of time spent
in the service
Technical Contracting Director
25%
Deputy Director, IFR
100%
Assistant Director, IFR
100%
IFR Senior Manager
IFR Team Manager x 4
100%
Technical Contracting, Contracting &
Quality Directorate
100%
IFR Officer x 4
100%
IFR Co-ordinator x 4
100%
IFR Assistant x 2
100%
Medicines Management
Contracting & Quality Directorate
Or CCGs
Public Health
Varies
Non-CSU
“
Panel Members
Various Non-CSU and CSU
“
Contracts Team
Contracting & Quality Directorate
“
Analytics
“
Central Strategic Business
Intelligence Team
It is proposed that the CSU IFR team will provide a suite of reports to include:
Reports for CCG ratification and sign-off, covering:
•
•
Outcomes of IFR panel decisions
Outcomes of triage panel decisions
Quarterly reports on quality and performance covering
•
•
•
•
•
•
•
Volumes and cost by CCG and by provider
Turnaround times of cases (referral-to-decision)
Service developments
Implications for contracting round
Impact on IFR policy
Media /Political interest
Horizon scanning for potential developments
The scope and frequency of these reporting requirements will need to be agreed with CCGs as
part of the operating model.
The IFR Team will work with CCGs to build a range of key performance indicators that will
reflect
•
•
Structural indicators that measure the availability of resources, such as the frequency of
panels
Process indicators that measure effectiveness, such as the turnaround time from referral to
decision
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Barnet CCG Governing Board meeting
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4 April 2013
Outcome indicators that measure success in meeting objectives, such as consistent
decision making with resolution clearly communicated.
Medicines Management and Public Health Support
The CSU IFR team will need to draw on the support and expertise from both public health and
medicines management colleagues to work up individual cases. As described above the CSU
IFR team will be able to sift cases through the triage process, provide information about similar
case work-ups and decisions and the wider-CSU team would be able to carry out an evidence
search for new cases.
The following table sets out the expected model from 1 April which will need to be reflected in
the Memorandum of Understanding for public health input.
CCGs will need to consider how much public health resource and medicines management
resource they will need to commission to support the process given the volumes of cases
handled by the services. As a rough guide, the triage process will require one public health
expert and one or two medicines management experts per pod for a 2 hour session per week.
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Barnet CCG Governing Board meeting
4 April 2013
This assumes that public health and medicines management colleagues could triage cases on
behalf of the local POD not just their own CCG locality.
The work-up of individual cases is of course variable and is still being worked through in detail.
Initial estimates, which need to be validated with local teams, would suggest that this can take
around one to one and a half days to research evidence and write-up the case. The time
needed to correspond with referring clinicians if further information is sought must also be
factored in, as will the time needed to present the case to the Panel. The time taken for
presenting cases could be used more effectively if presenters give their evidence over the
phone in a panel, rather than travelling to the panel meetings in person.
Resource required is assuming that each case takes 2 working days i.e. 0.4 of a working week.
This should allow enough tolerance to accommodate half a day for presentation and travelling
and a commitment to provide input to the triage once every 4 – 6 weeks. The model assumes
that the number of working weeks in one year is 44 (assuming 8 weeks for annual leave and
bank holidays).
The medicines management input for WELC CCGs is included in the CSU service offer, but
input for others remains responsibility of those CCGs and this expert input is essential for the
operation of the IFR process. Similarly the public health expertise is essential for the IFR
process and the CCGs will need to secure this continued input from public health as it moves to
into the local authority domain.
Support to case work-up
The workshops identified a common need for the CSU to provide focused support to both public
health and medicines management colleagues to make the most effective use of their expertise
and valuable resource. The support required includes:
•
•
•
•
The IFR Team will ensure that cases coming to public health and medicines management
have core patient information.
Details of any previous applications regarding the same patient will be included
Details of requests for similar treatments and research evidence used will be shared
The Business Intelligence Team will share research evidence and support literature
searches
Recommendations and next steps
Barnet CCG is asked to:
• Agree the draftIFR policy and proposed operating model
• Establish a committee of the Governing Body, to be known as the Individual Funding
Requests (IFR) Panel
• Establish a sub-committee of the IFR Panel, to be known as the IFR Appeals Panel
• Nominate a member or manager to determine requests at the triage stage of the process
and to take urgent action in respect of IFR requests as necessary
• Update the Scheme of Delegation to reflect the powers delegated to the IFR Panel and IFR
Appeals Panel
• Review the CCG constitution and insert suggested text at 6.6.3 - committees of the
Governing Body
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Individual Funding Request Policy
Interim Policy
Operational 1 April 2013 to 30 September 2014
Individual Funding Request Policy
4 April 2013
Document Control
Date
Status
Summary of Changes
30.1.13 First Draft for CCG
COs to review
11.2.13 Updated to reflect
NHS CB draft
policy
Sections from draft policy
inserted throughout. Some
additions included from the
NCL policy
Version
Owner
v.0.1
Anna Stewart
v.0.2
13.2.13 Updated to include
comments from
Susan AylenPeacock
v.03
14.2.13 Updated to include
comments from
Capsticks
v.04
18.2.13 Updated to include
comments from
Capsticks
Changes made to reflect
Capsticks
Sections on page 17 on
definitions moved
v.04.1
22.2.13 Updated to reflect
additional phone
call with Capsticks
v.05
7.3.13
v.06
Updated to reflect
comments back
from CCGs
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Individual Funding Request Policy
4 April 2013
Contents
Page 11 of 40
Individual Funding Request Policy
1.
4 April 2013
Introduction
The following policy has been adopted individually by the following Clinical Commissioning Group
(CCG) Governing Bodies:
•
•
•
•
•
•
•
•
•
•
•
•
Barking & Dagenham CCG
Barnet CCG,
Camden CCG
City & Hackney CCG
Enfield CCG,
Haringey CCG
Havering CCG
Islington CCG
Newham CCG
Redbridge CCG
Tower Hamlets CCG
Waltham Forest CCG
The policy sets out each individual governing body’s decision making process for managing Individual
Funding Requests (also known as exceptional funding requests),the delegated responsibility and
legal framework for decision-making within each CCG constitution. It is underpinned by a detailed
operational procedure which outlines how the process will be administrated on each CCG’s behalf by
the North and East London Commissioning Support Unit.
CCGs are from 1 April 2013 the statutory bodies responsible for commissioning healthcare services
for their population. Provision and delivery of health care services are usually undertaken as a
contract process underpinned by Service Level Agreements (SLAs). There are some treatments and
services that fall outside these commissioned portfolios or where the approval for the treatment is
dependent on specific criteria. From 1 April 2013 the NHS Commissioning Board will be responsible
for directly commissioning a range of specialised services and this policy does noes cover those
services.
In a changing health care economy there is a need to keep the Individual Funding Request (IFR)
policy and related policies under review and to commission services in line with new guidelines,
national policy and needs of the local population. This policy is guided by the legislative duties
bestowed on CCGs under the Health and Social Care Act 2006 (as amended by the Health and
Social Care Act 2012, NHS Constitution, The Human Rights Act 1998, and Equality Act 2010
amongst others. It also notes the relevant national guidance including “The Mandate” A mandate
from the Government to the NHS Commissioning Board (NHS CB) April 2013 – March 2015 and
“Developing and updating local formularies” NICE.
Given that this policy has been adopted at the point of major system transition, it will be adopted for a
time limited period and reviewed by no later than September 2014 to ensure that it can be updated to
reflect any feedback and learning from the way that the functional successor organisations,
particularly the NHS CB and CCGs, work together to commission healthcare services.
2.
Legal context to decision making
The scope of this policy is to specify the principles, processes and procedures for considering
whether or not to approve individual funding requests (IFRs) under these circumstances. This section
sets out the legal and ethical considerations relevant to the IFR process.
2.1
NHS Constitution
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Individual Funding Request Policy
4 April 2013
The foremost amongst these considerations are the following patient rights, specified under the NHS
Constitution 1 and underpinned by law:
“You [the patient] have the right to access NHS services. You will not be refused access on
unreasonable grounds.”
“You [the patient] have the right to expect local decisions on funding of other drugs and
treatments to be made rationally following a proper consideration of the evidence. If the local
NHS decides not to fund a drug or treatment you and your doctor feel would be right for you,
they will explain that decision to you.”
2.2
Legal and financial duties and the duty to provide services
Under the NHS Act 2006 2 (amended 2012) the CCGs; the NHS CB and the Secretary of State have a
concurrent duty to provide a comprehensive health service. For CCGs, the following applies:
“must provide …., to such extent as he considers necessary to meet all reasonable
requirements:
(c) medical, dental, ophthalmic, nursing and ambulance services,
(e) such other services or facilities for the prevention of illness, the care of persons suffering
from illness and the after-care of persons who have suffered from illness as he considers are
appropriate as part of the health service,
(f) such other services or facilities as are required for the diagnosis and treatment of illness.”
In addition to this duty to meet the above requirements, CCGs have a statutory obligation to maintain
financial balance. When considering whether or not to commission specific treatments for groups of
people with the same medical condition, CCGs will assess the clinical and cost effectiveness of the
treatment, the benefits to patients in terms of quality of life and the priority of this treatment or service
in relation to others already commissioned or proposed for commissioning. So a treatment of very
little benefit is unlikely to be commissioned simply because it is the only treatment available, this
ensures that limited resources are used to provide the greatest health benefit.
At an individual or patient group level, treatment will not generally be funded solely because a patient
requests it. CCGs will not normally fund treatment for one patient, which is not available to all other
patients with the same clinical need, except in the context of this policy.
CCGs will not discriminate on grounds of personal characteristics, such as age, gender, sexual
orientation, race, religion, lifestyle, social position, family or financial status, intelligence or cognitive
functioning and will act in compliance with duties under the Equality Act 2010. However, funding
decisions will be made on the basis that the patient is more likely to benefit significantly differently
from the cohort of patients with the same clinical condition.
2.2
Administrative Law
Decisions made by public bodies including CCGs can be challenged in the Administrative Court by
way of judicial review. The traditional grounds for judicial review are that the public body:
1
The NHS Constitution March 2010
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_113
645.pdf
2
The NHS Act 2006
http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_063171.p
df
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Individual Funding Request Policy
•
•
•
•
4 April 2013
acted beyond its lawful powers
came to a decision which no other reasonable CCG could have reached
acted unfairly, because it did not follow proper procedures
breached the patient’s human rights.
These grounds are the basis for the Appeals Process set out in this document.
The main impact of the Equality Act 2010 3has been the duty on health bodies to monitor their
compliance – extending the race equality monitoring to gender, religious belief and sexual orientation
where this is relevant – and to give due regard to the public sector equality duty. This policy complies
with the Equality Act 2010.
2.3.
The Human Rights Act 1998
The Human Rights Act 1998 4, Article 6 requires a fair hearing for determining civil rights and
proportionality of decision-making which the courts consider a fair balance between protection for
individual rights and the interests of the community. The proportionality test involves balancing
different interests – such as those of the individual applicant for treatment funding with those who
await service improvements that depend on the availability of new funding. Other key considerations
are Articles: 2 (the right to life); 3 (the right not to be subjected to inhumane or degrading treatment);
8 (the right to respect for privacy and family life); 12 (the right to marry); and 14 (the requirement for
non-discrimination against groups because of their sex, race, religion, disability, disease).
2.4.
Statutory duty of quality
CCGs need to demonstrate compliance with a statutory duty of quality, in accordance with the NHS
Health and Social Care Act 2006 (amended 2012) with specific consideration of the following points in
section 14:
• s.14P (Duty to promote NHS Constitution);
• s14Q (Duty as to effectiveness, efficiency and economically);
• s14R (Duty as to improvement in quality of services);
• s14T (Duties as to reducing inequalities);
• s 14U (Duty to promote involvement of each patient) and
• s 14V (Duty as to patient choice).
The process for assessing and making decisions about individual funding requests should be timely
and flexible enough to respond rapidly where the health of an applicant mandates a more urgent
decision.
2.5.
Ethical Considerations
The four principles widely used in medical ethics are:
• Autonomy: respecting the decision-making capacities of individual people to make their own
reasoned informed choices
• beneficence: considering the balance between the benefits of an intervention against its risks
and costs and choosing the one with greater benefit to the individual patient
• non malfeasance: avoiding the causation of harm and ensuring any is proportionate to the
benefits of treatment
3
http://www.legislation.gov.uk/ukpga/2010/15/contents
http://www.opsi.gov.uk/acts/acts1998/ukpga_19980042_en_3#sch1
4
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Individual Funding Request Policy
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4 April 2013
distributive justice: sharing benefits equitably, and risks and costs fairly; so that patients in
similar positions should be treated in a similar manner irrespective of age, sex, race, disability
and employment
2.6
Free Choice
The Department of Health published guidance on ‘Free Choice’ in March 2008, effective from 1 April
2008. The guidance sets out a commitment to free choice in elective care meaning that all patients
needing planned elective care will be able to choose to be treated by any provider that meets
eligibility criteria and NHS clinical and financial standards. Exclusions to Free Choice include referrals
from secondary and tertiary care, those living in Northern Ireland, Scotland or Wales, overseas
treatments, prisoners and military personnel.
Patients who wish to choose a service not commissioned locally and not listed on the national menu
of providers will continue to need their commissioner’s agreement to do so. Maternity care and
mental health services were excluded from this policy, however this could be subject to change in the
future. The Free Choice policy explicitly states that it does not contravene local commissioning
decisions about priority treatments. These guidelines need to be read in that context.
3.
The Scope of this Policy
This policy applies to any patient who is in circumstances where one of the North and East London
CCGs is the responsible commissioner of NHS care for that person. This policy specifically excludes
NHS services directly commissioned by the NHS Commissioning Board.
The scope of this policy is to specify the principles, processes and procedures for considering
whether or not to approve individual funding requests.
This policy will be consistent with each CCG’s constitution and commissioning decision-making
process in respect of:
• Operational commissioning through the annual Operating Plan for each CCG;
• Clinical guidelines and policies adopted by each CCG; and
• The interface with Specialised Commissioning in order that under the scope of this policy
CCGs do not make decisions on funding areas which fall outside of their statutory
responsibility.
This policy also recognises the need for commissioners to review, regularly, the funding of particular
interventions on the basis of value for money and cost effectiveness. Through the CSU the IFR
administrative teams will be responsible for providing regular reports to CCG commissioners on the
decisions made by the panels, including patterns and trends in requests for individual funding. They
will also support a process for evaluating the clinical and cost-effectiveness of provider businesscases against with the same rigour as an IFR to enable CCGs to make commissioning decisions for a
wider population.
3.1.
Objectives
Individual funding requests need to be understood in the context of routinely funded services. Most
established treatments and services are subject to routine clinical commissioning arrangements: a
portfolio of contracts and service level agreements, clinical commissioning policies, mandatory
National Institute of Health and Clinical Excellence (NICE) technology appraisal guidance.
This guidance note is intended to distinguish the broad types of request that may be received. These
are where the request:
• Represents a service development for a cohort of patients
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Individual Funding Request Policy
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4 April 2013
Is on grounds of clinical exceptionality where there are commissioning arrangements in place
Is on grounds of rarity and no commissioning arrangements exist
Is for a new intervention or for the use of an intervention for a new indication where no
commissioning arrangements exist
The objectives of the Individual Funding Request (IFR) policy are to:
•
summarise the groups of patients to which this policy applies
•
detail the information required and the decision making processes for individual patient
treatment funding requests, including the delegated accountability from CCG governing
bodies and roles and responsibility of the IFR Panel members
•
promote timeliness, fairness, transparency and rationality in how those requests are
managed and how decisions are made
•
describe the accountability of the IFR Panels and the IFR Appeal Panels and their
relationship to each CCG governing body
•
clarify the appeal process for Individual Funding Requests, including the role of each CCG
IFR Appeal Panels
3.2.
This policy applies to
Patients and treatments that fall into the ‘not normally funded’ category that need to be considered on
an individual patient basis. These include:
Category 1: procedures of limited clinical value or effectiveness that require prior approval to confirm
that the individual is eligible for treatment according to the agreed threshold criteria.
Category 1 applications are managed by the CSU IFR team for Islington, City & Hackney, Newham,
Tower Hamlets, Waltham Forest, Barking & Dagenham, Havering and Redbridge. For Barnet,
Camden, Enfield and Haringey they are managed by CCG commissioned Referral Management
Centres (RMCs).
Category 2: Other CCG Contract Exclusions:
• interventions prior to NICE evaluation
• interventions that NICE has evaluated as not generally cost effective
• treatments covered by NICE Technology Appraisal Guidance criteria that the patient does not
meet
• treatments in Category 1 where the patient does not fulfil the agreed funding criteria
• requests to continue funding for patients previously treated:
o within a clinical trial
o by self-funding
o through a decision made by another CCG commissioner where the patient has become
the commissioning responsibility of a CCG covered by the terms of this policy
• requests for referral to a service not commissioned locally and not listed on the national menu
• those which are not funded through CCG Operating Plans and commissioning contracts
If overseas treatment is confirmed as in the CCGs’ commissioned portfolios, rather than the NHS CB,
these categories would also apply to overseas treatment requests. To ensure clinical consistency of
decision making the IFR Panel may be asked to review applications for overseas treatment.
3.3.
The Policy is designed to ensure that the IFR Panels will
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•
•
4 April 2013
ensure consistency in decision making maintaining a record of prior decisions and referring to
precedent where relevant
share experience gained in dealing with requests for individual patients within and across
CCGs
3.4.
Policy Exclusions
The IFR process is not the route through which CCG commissioning policy for a group of patients will
be made. This would require CCG evaluation of a potential service development and any change to
the CCG commissioned service portfolio would be prioritised through the annual Operating Plan
process. The process for agreeing contract service variations is described in the NHS standard
contracts, published by the Department of Health.
The policy therefore excludes consideration of an IFR for a single patient that would be relevant to a
group of similar patients, because as above CCGs will not fund treatment for one patient which is not
available to all other patients with the same clinical need.
The CCG member or manager with delegated authority to make IFR triage decisions will receive a
summary of recommendations for determination of IFRs rejected or approved at the triage stage (see
later) as a result of the application of the agreed policy exclusions for them to approve. This process
will inform CCG commissioners where relevant that consideration should be given to developing or
revising CCG commissioning policy.
If, in exceptional circumstances, in-year evaluation and prioritisation of a service development is
considered justified a separate CCG process, supported by the CSU would be convened to consider
business cases from providers.
4.
Patient Group Definitions
The UK Faculty of Public Health has published a statement describing the concept of exceptionality:
“It is important to distinguish between an exceptional case and as an individual funding request. In an
exceptional case, a patient seeks to show that he or she is an ‘exception to the rule’ or policy and so
may have access to an intervention that is not routinely commissioned for that condition. In contrast,
an individual funding request arises when a treatment is requested for which the commissioning
organisation has no policy. This may be because:
•
•
•
It is a treatment for a very rare condition for which the commissioners have not previously
needed to make provision or
There is only limited evidence for use of the treatment in the requested application or
The treatment has not been considered by the commissioners before because it is a new way
of treating a more common condition. This should prompt the development of a policy on the
treatment rather than considering the individual request unless there is grave clinical urgency.”
Service developments and cohorts of similar patients
A service development is any aspect of health care which the NHS has not historically agreed to fund
and which will require additional and predictable recurrent funding.
The term refers to all decisions which have the consequence of committing the CCGs to new
expenditure for a cohort of patients including:
• new services
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•
•
•
•
•
•
•
4 April 2013
new treatment including medicines, surgical procedures and medical devices
developments to existing treatments including medicines, surgical procedures and medical
devices
new diagnostic tests and investigations
quality improvements
requests to alter an existing policy (called a policy variation). This change could involve adding
and in an indication for treatment, expanding access to a different patient subgroup or
lowering the threshold for treatment.
pump priming to establish new models of care
requests to fund a number of patients to enter a clinical trial commissioning a clinical trial.
It is normal to consider funding new developments during the annual commissioning round. An inyear service development is any aspect of health care, other than one which is the subject of a
successful individual funding request, which the commissioning organisation agrees to fund outside of
the annual commissioning round.
When a commissioning organisation considers funding a service development outside the normal
commissioning process it is particularly important that those taking the decision pay particular
attention to the impact that this may have on the CCG’s opportunity to fund other areas of competing
health needs.
It is common for clinicians to request an individual funding request for a patient where a request is,
when properly analysed, the first patient of a group of patients wanting a particular treatment. For
example, a new drug has been licensed for a particular type of cancer and for patients with particular
clinical characteristics. Any individual funding request which is representative of this group represents
a service development. As such it is difficult to envisage circumstances in which the patient can be
properly classified to have exceptional clinical circumstances. Accordingly the individual funding
request route is usually an inappropriate route to seek funding for such treatments as they constitute
service developments. These funding requests are highly likely to be returned to the provider trust,
with the request being made for the clinicians to follow the normal processes to submit a bid for a
service development.
A request for a treatment should be classified as request for a service development if there are likely
to be a cohort of quote similar patience quota who are:
a) in the same or similar clinical circumstances as the requesting patient;
b) whose clinical condition means that they could make a similar request (regardless as to
whether a request has been made) and
c) who could reasonably be expected to benefit from the requested treatment to the same or a
similar degree.
The concept of a cohort of similar patients
There needs to be a distinction between cases where the clinical circumstances are genuinely
exceptional and those where the presenting clinical circumstances are representative of a small
group of other patients.
Where the presenting clinical circumstances are representative of the small group of other patients,
the policy of the North and East London CCGs is that the decision to fund or not is a policy decision
and not just a funding decision for an individual patient i.e. that it has wider funding implications. This
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ensures the outcome of the decision is applied equally to all the other patients who have the same
presenting clinical circumstances and the principle of privatisation is upheld.
What is a “cohort of similar patients”?
A cohort of similar patients for the purpose of this policy has been defined as five or more patients, or
equalling an impact of £100k or more per annum in the population served by a single CCG.
The IFR panels are not entitled to make policy decisions for the CCGs. Where a request has been
classified as a service development, the IFR panel is not the correct body to make a decision about
the individual funding request. In such circumstances the individual funding request will not be
presented to the IFR panel.
Where an IFR has been classified as a service development, the options open to the IFR panel
include taking the following steps:
•
•
•
To refer the case back to the provider and request it prioritises the service development
internally within its provider organisation and, if supported, to invite the provider to submit a
business case as part of the annual commissioning round for the requested service
development.
To refuse funding and initiate an assessment of the service development within the North and
East London CCGs, with a view to determining its priority for funding in the next financial year.
To refer the request for funding for immediate work-up of the service development as a
potential candidate for in-year service development.
Exceptionality
What is meant by exceptional circumstances?
There can be no exhaustive definition of the conditions which are likely to come within the definition of
an exceptional individual case. The word “exception” means “a person, thing or case to which the
general rule is not applicable”.
The IFR panel should bear in mind that, whilst everyone's individual circumstances are, by definition,
unique, very few patients have clinical circumstances which are exceptional, so as to justify funding
the treatment for that patient which is not available to other patients. The following points constitute
general guidance to assist the panel. However, the overriding question which the panel needs to ask
itself remains: has it been demonstrated that this patient’s clinical circumstances are exceptional?
a) It may be possible to demonstrate exceptionality where the patient has a medical condition
or circumstance that is so rare that the result of the North and East London CCGs
prioritisation process provides no established treatment care pathway for that treatment.
b) If the patient has condition for which there is an established care pathway, the panel may
find it helpful to ask itself whether the clinical circumstances of the patient are such that they
are exceptional as compared to the relevant subset of patients with that medical condition.
c) The fact that the patient failed to respond to, or is unable to be provided with, one or more
treatments usually provided to a patient with his or her medical condition (either because of
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another medical condition or because the patient cannot tolerate the side effects of the usual
treatment) may be a basis upon which panel could find that the patient is exceptional.
However, the panel would normally need to be satisfied that the patient's inability to respond to, or be
provided with, the usual treatment was genuinely an exceptional circumstance. For example:
a) If the usual treatment is only effective for a proportion of patients (even if a high proportion),
this leaves a proportion of patients for whom the usual treatment is not available or it is not
clinically effective. If there is likely to be a significant number of patients for whom the usual
treatment is not clinically effective or not otherwise appropriate (for any reason) the fact that
the requesting patient falls into that group is unlikely to be a proper ground on which to base a
claim that the requesting patient is exceptional.
b) If the usual treatment cannot be given because of the pre-existing co-morbidity and its
impact on treatment options, which could not itself be described as exceptional in this patient
group, then the fact that the co-morbidity is present in this patient is unlikely to make the
patient exceptional.
The most appropriate response in each of the above situations, is to consider whether there is
sufficient justification (including consideration of factors such as clinical effectiveness, value for
money, priority and affordability) to make a change to the policy adopted by the North and East
London CCGs for funding that patient pathway so that a change can be made to that policy to benefit
a sub-group of patients (of which the requesting patient is potentially one such person). This change
needs to be considered as a service development.
Non-clinical factors
It is common for an application that individual funding be provided to be on the grounds that the
patient's personal circumstances are exceptional. This assertion can include details about the extent
to which other persons rely on the patient, or the degree to which the patient has contributed or is
continuing to contribute to society. The North and East London CCGs understand that everyone's life
is different and that such factors may seem to be of vital importance to patients in justifying
investment for them in the individual case. However, including non-clinical factors in any decisionmaking raises at least three significant problems for the commissioning organisation:
a) Across the population of patients to make such applications, the Panel is unable to
make an objective assessment of material put before it relating to non-clinical factors.
This makes it very difficult for the panel to be confident of dealing in a fair and evenhanded manner with incompatible cases.
b)
The essence of an individual funding application is that the Panel is making funding
available on a one-off basis to a patient where other patients with similar clinical
conditions would not get such funding. If non-clinical factors are included in the
decision making process, the Panel does not know whether it is being fair to other
patients who were denied such treatment and whose non-clinical factors are not
entirely unknown.
c) The North and East London CCGs are committed to a policy of non-discrimination in
the provision of medical treatment. If, for example, treatment was to be provided on the
grounds that it would enable an individual to stay in paid work then this would
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potentially discriminate in favour of those working compared to those not working. The
same can be said of many other non-clinical factors such as having children/not having
children, being a carer/not being acarer and so on. Requests to fund treatment of
adolescents on the grounds that not funding treatment would prevent the individual
from fulfilling their true educational potential or because of a person's role in society
are also potentially discriminatory and would contribute to inequality.
Generally, the NHS does not take into account non-clinical factors in deciding what treatment to
provide. It treats the presenting medical condition and does not enquire into the background and risk
factors which led to that condition as the basis on which to decide whether to make treatment
available or not. The CCGs will therefore seek to commission treatment based on the presenting
clinical condition of the patient and not based on the patient's non-clinical circumstances.
In reaching a decision as to whether a patient's circumstances are exceptional, the panel is required
to follow the principles set out above.
Clinicians are asked to bear this policy in mind and not refer to non-clinical factors to support the
application for individual funding.
Proving the case that the patient's circumstances are exceptional
The onus is on the requestor to set out the grounds clearly for the panel on which it is said that this
patient is exceptional. The grounds will usually arise out of exceptional clinical manifestations of the
medical condition, as compared to the general population of patients with the medical condition which
the patient has.
These grounds must be set out on the specified form and should clearly set out any factors which the
clinician invites the panel to consider as constituting a case of exceptional clinical circumstances. If,
for example, it is said that the patient cannot tolerate the usual treatment because of the side effects
of another treatment, referring clinicians must explain how common it is that the patient with this
condition would not to be able to be provided with the usual treatment.
If a clear case as to why the patient's clinical circumstances are said to be exceptional is not made
out, then the Panel may defer the application and request further information. The Panel recognises
that the patient’s referring clinician and the patient together are usually in the best position to provide
information about the patient’s clinical condition as compared to the sub-set of patient’s with that
condition. The referring clinician is advised to set out the evidence in detail because the Panel will
contain a range of individuals with a variety of skills and experiences that may well not contain
clinicians of that speciality. The North and East London CCGs therefore require referring clinicians, as
part of their duty of care to the patient, to explain where the patient’s clinical circumstances are said
to be exceptional.
The policy of the North and East London CCGs is that there is no requirement for the Panel to carry
out its own investigations about the patients circumstances in order to try to find the ground upon
which the patient may be considered to be exceptional nor to make assumptions in favour of the
patient if one or more matters are not made clear within the application. Therefore, if a clear case of
exceptionality is not made out by the paperwork placed before IFR Panel (and if further information
requested fails to make this clear) the Panel would be entitled to turn down the application.
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Multiple claimed grounds of exceptionality
There may be cases where clinicians and/or patients seek to rely on multiple grounds to show their
case is exceptional. In such cases the panel should look at each factor individually to determine (a)
whether the factor was capable of making the case exceptional and (b) whether it did in fact make the
patient’s case exceptional.
Rarity
The assessment of requests to fund existing treatments experimentally for patients with rare clinical
circumstances should be distinguished from requests on the grounds of exceptionality.
A set of criteria need to be applied when a patient's medical condition is so rare, or their condition is
so unusual, that the clinician wishes to use an existing treatment in an experimental way. This
exception does not routinely apply to rare disorders or small sub-groups of patients with a more
common disorder because here it would be normal to have a trial involving sufficient patients formally
to evaluate the proposed treatment in the trial.
In assessing these cases the panel should consider the following:
a) Can this treatment be studied properly using any other established method? If so then
funding should be refused.
b) Is the treatment likely to be clinically effective?
c) In addition the usual considerations are included. Does the treatment provide value for
money, and what is this patient’s priority compared to patient's whose care has not been
funded.
Request for use of a new intervention, or the use of an intervention for a new indication, where
no commissioning arrangements exist
If the request is for a new intervention, or is a new application of an existing intervention, for which the
patient represents a cohort of patients, then the IFR process is not appropriate and the requestor will
be directed to the process requesting a service development.
IFR Applications
Clinicians, on behalf on their patients, are entitled to make an individual funding request to the CCG,
via the North and East London Commissioning Support Unit, for treatment that is not normally
commissioned by CCG under the following conditions:
•
•
•
•
The request does not constitute a request for a service development, or
The patient is suffering from a medical condition in which the CCG has commissioning
responsibility, or
The patient is suitable to enter clinical trial which requires explicit funding by the CCG, or
The patient has a rare clinical circumstance that renders it impossible to carry out clinical
trials, and to whom the clinician wishes to use existing treatment on an experimental basis.
The clinical applicant is expected to identify which of the above apply.
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Applications should be made by the:
• Patient’s GP or another GP from the practice
• Clinician to whom the patient has been referred
Due to the level of detail required in the application form it is unlikely to be known by the patient and
therefore applications from individual patients will not be accepted. The IFR panel needs to be
assured that an NHS clinician can describe precisely why they consider the treatment to be
appropriate for the particular patient and that an NHS provider has agreed to carry out the treatment
for which funding is requested.
Due to the highly sensitive nature of the information being sent (and for reasons of efficiency),
applicants are required to make IFR applications between NHS net email accounts.
4.1.
Information Required
All applications must be accompanied by written support and evidence provided by the clinical team
treating the patient. It is the clinician's responsibility to ensure that the appropriate information is
provided to the panel according to the type of request being made.
In all circumstances the lead treating clinician must state whether or not he or she considers there are
similar patients and if so how many patients there are.
All clinical teams submitting IFR requests must attempt to ensure that all information that is likely to
be immaterial to the decision, including information about the social or personal circumstances of the
patient or information which does not have a direct connection to the patience clinical circumstances,
shall not be included in the application. If any immaterial information is included it shall not be
considered by the IFR panel.
Implementation of this policy requires extensive information on each patient to ascertain whether:
• the patient complies with the agreed threshold criteria for Procedures of Limited Clinical
Value/Effectiveness OR
• there are valid reasons to consider that the CCG could justify funding the treatment for this
patient when the treatment in question is not available for similar patients in the CCG area
IFR application forms are designed to capture all material information to enable due consideration
according to this policy. Information requested will include but not be limited to:
• Details of the patient’s registered GP
• Details on the patient’s condition, prior treatment and response to this
• Details of the intervention including duration, how response to the treatment will be assessed,
criteria for stopping, whether the intervention is likely to lead to other types of treatment in
addition to that for which the application is submitted
• The expected benefits of the treatment in the patient for whom it is requested
• Potential alternative treatment and its expected benefit
• The cost of the requested and potential alternative intervention including VAT where relevant
• The clinical urgency of the decision (if relevant)
• Confirmation of patient consent to contact relevant health professionals
• An explicit statement of why the patient differs from others with the same clinical condition
such that the treatment should be considered for them when it is not available to others with a
similar clinical condition
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Submission of the complete information will minimise avoidable delay in the assessment process.
The application form should be accompanied by electronic copies of, or electronic links to, published
evidence of clinical effectiveness and likelihood of benefit. These should be attached to the secure
email.
Triaging individual funding requests
All cases referred to the CCGs via the IFR Team will be subject to initial triage to ensure sufficient
information has been provided and whether consideration by the IFR Panel is the most appropriate
route. A CCG member or manager with delegated responsibility for the triage process will be
presented with recommendations from the Triage panel on which to make a determination.
Screening for service developments
All individual funding requests submitted to the IFR Team will be subject to screening to determine
whether the request represents a service development. Service developments include, but are not
restricted to:
•
•
•
•
•
•
•
•
New services
New treatments including medicines, surgical procedures and medical devices
Developments to existing treatments including medicines, surgical procedures and medical
devices
New diagnostic tests and investigations
Quality improvements
Requests to alter an existing policy (called a policy variation). The proposed to change could
involve adding in an indication for treatment, expanding access to a different patient subgroup
or lowering the threshold for treatment.
Request to fund the number of patients to enter a clinical trial.
Commissioning a clinical trial.
Screening for incomplete submissions
If the request is not categorised as a service development, it will be subject to screening to determine
whether the request has sufficient clinical and other information in order for the individual funding
request to be considered by the panel. Where information is lacking, the individual funding request
will be deferred and returned to the provider specifying the information which would be required in
order to enable this request to proceed. The request can be submitted at any point.
Identification bias
The IFR panel shall take care to avoid identification bias, often called the “rule of rescue”. This can be
described as the imperative people feel to rescue identifiable individuals facing avoidable death or a
preference for identifiable over statistical lives. The fact that the patient has exhausted all NHS
treatment options for a particular condition is unlikely, of itself, to be sufficient to demonstrate
exceptional circumstances. Equally, the fact that the patient is refractory to existing treatments were
recognised proportion of patients with the same presenting medical condition at this stage are, to a
greater or lesser extent, refractory to existing treatments is unlikely, of itself, to be sufficient to
demonstrate exceptional circumstances.
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4.2.
4 April 2013
Urgent Applications
The IFR process is designed for planned care and cannot give adequate consideration to cases in
less than 3 working days. However, the North and East London CCGs recognise that there will be
occasions when an urgent decision needs to be made to consider approving funding for treatment for
an individual patient outside the CCG's normal policies. In such circumstances, an urgent decision
may have to be made before a panel can be convened. The following provisions apply to such a
situation:
•
•
An urgent request is one which requires urgent consideration and a decision because the
patient faces a substantial risk of death or significant harm if a decision is not made before the
next scheduled meeting of the IFR panel.
Urgency under this policy cannot arise as a result of a failure by the clinical team expeditiously
to seek funding through the appropriate route and/or where the patient's legitimate
expectations have been raised by commitment being given by the provider trust to provide a
specific treatment to the patient. In such circumstances the North and East London CCGs
expect the provider trust to proceed with treatment and for the provider to fund the treatment.
Provider trusts must take all reasonable steps to minimise the need for urgent request to be made
through the IFR process. If clinicians from any provider trust are considered by the CCG not to be
taking all reasonable steps to minimise urgent request to the IFR process, the CCG may refer the
matter to the provider trust chief executive.
If the clinical decision needs to be made within this timescale the trust should proceed at its own
financial risk and submit an IFR application which will be considered at the next available IFR Panel
meeting.
In the event that a funding decision is requested between 3 working days and the next available IFR
Panel meeting, the applicant should contact the IFR team so that the CCG lead with delegated
responsibility for the IFR process can agree whether it is necessary to convene a virtual panel.
The referring clinician for an urgent application should:
• Identify the application as urgent and confirm this by phone
• Inform the IFR team of the clinical rationale for the urgency
• Ensure their contact details are available to the IFR team so that the CCG lead with
delegated responsibility or a clinician within the IFR team can discuss the urgency and an
accelerated timeline can be agreed should this be considered to be appropriate.
Procedures of Limited Clinical Value/Effectiveness will not be considered as urgent applications
under any circumstances.
4.3.
Validation of the IFR Application
CCGs will only consider funding for patients registered with a General Practitioner in their area or
demonstrably resident within the CCG geography and without a registered GP elsewhere in the UK,
who is entitled to receive NHS treatment.
The CSU IFR team on behalf of the CCG (with access to commissioning, medicines management
and public health advice as appropriate) will also:
• verify that the application is appropriate for consideration through IFR processes.
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•
•
confirm that the requested intervention is not included within any CCG contract for clinical
services and advise the applicant where another route is appropriate
confirm that the application is appropriate for the IFR Panel - specifically that it is not a request
for one patient that is representative of a group of similar patients (a ‘policy exclusion’). If this
is the case, the referring clinician will be advised about the process for considering new
service developments as part of the following year’s Operating Plan process.
o
o
4.4.
4 April 2013
Category 1 applications: the onus is on the clinical applicant to fully demonstrate that the
patient meets eligibility criteria or detail why the patient differs from others with the same
clinical condition such that the treatment should be considered for them when it is not
available to others with a similar clinical condition;
Category 2 applications: the onus is on the clinical applicant to demonstrate the reason
why this patient is so different from others with the same condition that the CCG should
consider funding a treatment that is not generally available;
Acknowledgement of the Application
The timeline for completed and appropriate applications is shown in Appendix XXX [to be added from
the SOP]. For non-urgent cases, the referral will be acknowledged within 3 working days of receipt
for applications received electronically and the process to be followed, including timetable for the next
panel meeting date (usually within the next month depending on when the completed application is
received in relation to Panel dates) will be confirmed.
5.
Process for Procedures of Limited Clinical Value/Effectiveness
The IFR teams will review these applications against the agreed criteria or treatment threshold as
appropriate as agreed by the relevant CCG. Recommendations which confirm patient eligibility will
be presented to the member of manger within the CCG for determination and if approved for funding
and the applicant notified. These discussions and recommendations will take place outside of the
IFR Panel through a triage process.
Applications where the patient is ineligible for funding will be referred to the IFR Panel provided that
the applicant has completed the appropriate section relating to the reason why the CCG could justify
funding the procedure for this patient when it is not available for similar patients in the CCG area. If
this information is not submitted a recommendation will be made to the lead member or manager
within the CCG with delegated responsibility for the IFR triage process that the application be rejected
at the triage stage.
5.
IFR Panels Accountability and Membership
5.1
Accountability
The IFR Panel is the decision-making body that is a component of the CCG commissioning decisionmaking process. Each CCG will establish its own IFR panel as a committee of the governing body
with decision-making capacity which will meet in common with other CCGs in the same Point of
Delivery Group (POD).This policy complies with the CCG constitution.
Accountability for the operational management of the IFR process within the CSU is through the
Director of Contracting and Quality.
5.2
Limit on the financial value of decisions
The upper limit on the financial value of decisions taken is £50k per annum per request: a decision for
an individual patient that will result in a cost of over £50k per annum will be referred to the CCG
Governing Body for formal approval, although very strong clinical reasons would be needed to
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overturn the recommendation of an IFR panel given that cost effectiveness will be one of the criteria
explicitly taken into account in the decision-making process.
5.3
Membership of the IFR panels
Each IFR Panel will be constituted as a committee of the CCG Governing Body and will have
delegated authority to determine IFR requests for that CCG. A model terms of reference is included
at Appendix A. The membership of each CCG’s IFR Panel is set out below:
Membership
Member of the relevant CCG governing body. (clinical director (GP), nursing
director or secondary care consultant)
• CCG member (panel chair), this could be a clinical director (GP), nursing director
or secondary care consultant
• Chief pharmacist/senior medicines management lead (CSU/CCG)
• Senior contracting representative (CSU/CCG)
• Public health representative
• Patient or lay representative
• CSU administrative support
• Pharmacy/medicines management
• Public health
• Contracting
• Any other specialist as requested by the chair as necessary or beneficial to the
decision making process
All full members must be present.
A committee of the CCG Governing body
•
Chair
Full members
Associate
members
Quorum
Governance
Members may nominate a suitable deputy if they are unable to attend, but these must be named in
advance and, in order to have the ability to vote, must be suitably experienced and trained. The
membership will be subject to review, as required.
Meetings of the IFR Panel will be held in common with other CCG’s IFR Panels in the groupings set
out below, which reflect the CSU point of delivery (POD) structures.
• Barnet, Camden, Enfield, Haringey and Islington
• Barking and Dagenham, Havering and Redbridge
• City and Hackney, Newham, Tower Hamlets and Waltham Forest
The business to be conducted for each CCG will be clearly segregated and during consideration of
each CCG’s cases the members of other CCGs will be in attendance on an associate (non-voting)
basis only.
There will be a clear separation of those presenting cases and the decision-making members of the
panel.
5.4
Conduct of meetings
In reaching a decision the Panel must take into account the principles of the NHS Constitution, which
sets out the rights of NHS patients. These rights cover how patients access health services, the
quality of care, the treatments and programmes available, confidentiality, information and the right to
complain if things go wrong. The Panel must ensure that it has acted in good faith, weighed all the
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relevant evidence, given proper consideration to the claims of patients and Clinicians, and accorded
proper weight to the needs of other groups, given the total resources available.
The Panel should strive to reach consensus on a judgement, which is in every sense reasonable.
Where there is not a consensus decision, a vote of the Panel’s membership should be taken, with
decision agreed by a simple majority of the voting Panel members present. The Panel shall maintain
accurate documentation of the whole process. It must take into account the implications of the
Freedom of Information Act 2000, the Human Rights Act 1998, the Equality Act 2010 and any
statutory codes of practice issued by the Equality and Human Rights Commission (EHRC), and other
relevant legislation. It recognises its public sector duties under the Equality Act 2010 which came into
force in April 2011. The Equality Act replaces all other equality legislation including the Race
Relations Amendment Act 2000, and the Disability Discrimination Amendment Act 2003.
The meeting of the IFR Panel is not a public meeting; patients, patient representatives or clinicians
are also not allowed to attend. The IFR Panel meetings discuss and assess the clinical evidence
provided by a clinical referrer. On request patients will be provided with all of the documentation put
before the Panel and are encouraged to submit written evidence and information to the Panel to be
considered in the assessment of their individual case.
The Panel will comply in full with the Data Protection Act 1998 and the Caldicott Guidelines when
handling patient identifiable information. In particular, patient identifiable information will be
anonymised where possible. All electronic communication will be conducted using secure NHS.net
email accounts to ensure patient confidentiality.
The Chair is responsible for ensuring that:
• adequate data and intelligence were available to inform the decision;
• all material factors have been taken into account and that immaterial factors have been
appropriately handled; and,
• the rationale for the decision has been explicitly recorded, against the terms of this policy, and
that the conflicting arguments have been managed.
The Chair will be accountable to their CCG Governing Body for the delivery of this role.
If the patient’s clinical condition is such that a more urgent decision needs to be reached then a virtual
panel (by conference call or email) will be organised, when sufficient information and evidence has
been gathered to present the case. A virtual IFR Panel will comprise the relevant Chair for the CCG
of patient’s case being considered and voting members of the panel as per actual panels to be
quorate. The outcome of the proceedings will be submitted to the next panel for information.
5.5
Conflicts of interest
If the application originates from a CCG panel member (or a practice in which they have an interest),
then a replacement shall be sought to chair the meeting and that member should exclude themselves
from the proceedings whilst that funding request is being discussed. In the event of any other panel
member having a conflict of interest, they shall acknowledge this and will remove themselves from
the proceedings whilst that funding request is being discussed. To avoid such a situation arising and
risk making a panel inquorate, panel members are advised to check the meeting papers in advance
and arrange for a deputy to be in attendance.
6.
IFR Processes
Approval of individual funding requests
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The IFR panel shall be entitled to approve requests for funding for treatment of individual patients
where all the following conditions are met:
• The IFR panel is satisfied that there is no cohort of similar patients. If there is a cohort of
similar patients the IFR panel should decline to make a decision because the application is
required to be treated as request for service development.
• There is sufficient evidence to show that, for the individual patient, the proposed treatment is
likely to be clinically and cost-effective or that the clinical trial has sufficient merit to warrant
NHS funding.
• Exceptional circumstances apply.
The IFR panel is not required to accept the views expressed by the patient or the clinical team
concerning the likely clinical outcomes of the individual patient of the proposed treatment but is
entitled to reach its own views on:
•
•
The likely clinical outcomes for the individual patient of the proposed treatment, and
The quality of the evidence to support that decision and/or the degree of confidence that that
IFR panel has about the likelihood of the proposed treatment delivering the proposed clinical
outcomes for the individual patient.
The IFR panel shall be entitled but not obliged to commission its own reports from any duly qualified
or experienced clinician, medical scientist or other person having relevant skills concerning the case
that it is being made that the treatment is likely to be clinically effective in the case of the individual
patient.
The IFR panel may make such approval contingent on fulfilment of such conditions as it considers fit.
There will be regular scheduled panels to ensure that delay to decision making is minimised.
Frequency may be increased if necessary to accommodate unexpected peaks.
Applications will be considered on the basis of the submitted evidence of the patient’s clinical
circumstances, ability to benefit, and the clinical and cost effectiveness of the proposed treatment. It
is the responsibility of the referring clinician to ensure that appropriate and sufficient evidence is
provided; the panel’s role will be to evaluate, not research, the evidence submitted in support of the
case.
Anonymised patient case summaries will be sent to panel members in advance of the meeting,
accompanied by available national (NICE, NHS Evidence, Cochrane Library, etc.) and/or regional
(Scottish, Welsh, English regional including London New Medicines and Treatments; New Drugs or
New Cancer Drugs) and/or local (agreed clinical policy or pathway) supportive evidence, where
provided/available, together with an assessment of the evidence of clinical and cost effectiveness
(evidence evaluation forms are used for this purpose, where necessary). This function and the timely
preparation of papers will be undertaken on behalf of CCGs by the CSU.
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Individual Funding Request Policy
7.
7.1.
4 April 2013
Factors that the panels will take into account in decision-making
The key issue for most IFR Panel patients will be:
On what grounds can the CCG justify funding this treatment for this patient when the
treatment in question is not available for similar patients within the CCG area?
In order for funding to be agreed there must be some unusual or different (exceptional) clinical factor
about the patient that suggests that they are:
• Significantly different to the general population of patients with the condition in question
• Likely to gain significantly more benefit from the intervention than might be 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 basis for funding.
These will be a guiding principle in the IFR Panels’ decision making.
7.2.
Legal Obligations
As outlined in earlier in the policy.
7.3.
In making a decision on funding the following will be taken into account:
• Is the treatment lawful – i.e. within its legal powers and takes into consideration the principles of
the Human Rights Act?
• Is the treatment safe? – ('first do no harm').Commissioners must ensure it is not complicit in
exposing patients to unsafe healthcare and will look to licensing Authorities (especially the Medicines
and Healthcare Products Regulatory Agency (MHRA) and other organisations (such as the National
Institute for Clinical Excellence (NICE) and the British National Formulary (BNF) for guidance.
•
Is the treatment effective – i.e. of proven benefit for this category of patient?
• In what way is the clinical condition of this particular patient significantly different from the group of
patients with the condition in question
• What is the evidence that this particular patient is likely to gain significantly more health benefit
than others with the same condition?
• What is the comparable clinical and cost effectiveness of any reasonable alternative intervention
and/or provider?
•
What are the equality considerations of funding this particular patient in relation to:
- precedent for funding other similar patients
- previous decisions of the relevant panel or predecessor panels
- reducing any inequality between this patient and others in a similar position
•
What is the priority in relation to the opportunity costs and potential alternative spend to meet
other needs of the whole population. Whilst specific economic assessments will not be carried
out, the IFR panels will note the national (NICE) threshold of £30,000/QALY of generally
acceptable cost effectiveness.
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•
4 April 2013
Is the treatment accessible – i.e. can people get to the service?
8.4.
Clinical Trials
Funding will not be granted for patients who started a drug or treatment as part of a clinical trial,
unless such funding has been agreed prior to commencement of the trial. This follows the Medicines
for Human Use (Clinical Trials) Regulation 2004 and the Declaration of Helsinki principles that the
responsibility for ensuring a clear exit strategy from a trial and whether those benefiting from the
treatment will have on-going access to it lies with those conducting the trial. The initiators of the trial
(NHS Provider Trusts and drug companies) have a moral and ethical obligation to continue funding
patients benefiting from treatment until such time as a CCG has agreed to commission the treatment.
8.
IFR panels operation
The panels will act in good faith to assess all the relevant evidence, giving proper consideration to the
claims of patients and clinicians and the evidence prepared by the presenters (usually public health or
medicines management) . It will avoid consideration of information irrelevant to the decision making
principles above unless these specifically impact on the likelihood or otherwise of the patient gaining
significantly more clinical benefit than other similar patients.
The IFR panels will strive to reach consensus on a decision that is reasonable and would be
perceived as such by other commissioning organisations, maximising the benefit gained from the
resources the CCG has available. Where the decision is not unanimous the votes of individual
members will be recorded and minuted in relation to their role rather than by name. The casting vote
will be with the Chair who will be a member of the CCG who will sit on the IFR Panel Committee of
the Governing body which will have delegated authority from the CCG Governing body to make
decisions on IFR cases.
The IFR panel chair with other IFR Panel members as assigned will ensure accurate documentation
of the panel discussion. The CSU will be responsible for the administration of high-quality minuting
and documentation of panel decisions.
The documentation of individual cases will be archived securely and catalogued so that they can be
made available when considering new applications.
The IFR Panels do not meet in public and attendance by the patient or the referring clinician is not
permitted. However patients have the right to submit written evidence and information to the panel to
be considered in the assessment of their individual case.
9.
9.1.
Notification of the IFR Panel Decision
The referring clinician/GP
The referrer will be notified of the IFR Panel decision including the reasons for the decision normally
within 10 working days (2 working days for urgent decisions) and copied to the patient’s GP where
appropriate. It is expected that, unless specifically requested, all communication between the CSU
team administering the IFR process and the applicant clinician will be via the secure nhs.net email
accounts. It is the responsibility of the clinician making the referral to inform the patient and any other
relevant healthcare professionals of the decision; this is to ensure effective on-going arrangements
for the patient’s care. The clinician making the referral is also responsible for notifying the patient of
the outcome of the decision and appeal process (including the time frame for the appeal).
9.2.
The Patient
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It is the responsibility of the applicant clinician to notify the patient of the outcome of the panel
decision. This is because in the event that the funding request is refused, the clinician is in the best
position to convey this information and discuss alternative treatment options. It is the decision of the
referring clinician as to whether they then share the outcome letter with the patient as part this
discussion, noting the patient’s rights under the NHS Constitution.
In the event of a decision not to approve funding, the notification will include the criteria by which
applications are assessed and include details of the procedure for registering an appeal against the
process by which the decision was taken.
If the applicant clinician or patient feels that relevant information was not available to the IFR Panel
when the decision was made, they should ask the Panel to reconsider the case specifically in the light
of this further information. If the Panel has reconsidered and declined the application after further
information has been submitted, then the applicant may seek to appeal the decision (see section xx:
the appeals process).
10.
Confidentiality
The CSU will hold patient level information on behalf of the CCGs to support the IFR process. All
patient information will be handled with confidence and stored in accordance with [xxx insert relevant
policy reference] relating to person identifiable information.
IFR panel members will take into account the need for confidentiality and operate under the Caldicott
guidelines. All patient specific electronic communication will be via a secure nhs.net connection.
The CSU will on behalf of CCGs, keep a full set of information electronically under a single record
number. Telephone calls relating to IFR enquiries will be logged and notes kept with the case file,
where appropriate. Relevant email communication and hard copy documents will be stored with the
electronic file
Electronic records and IFR Panel minutes will be saved securely and access will be available to
authorised staff only. Panel member hard copy records must be disposed of as confidential waste.
11.
11.1.
The appeals process
The Remit of the Appeal Process
The purpose of the appeals process is not to consider the clinical merits of the case, but whether due
process has been followed in the IFR decision-making process (as described in this policy). This is a
quality assurance scrutiny and as such is comparable to the Judicial Review and NICE Appeals
processes.
11.2 Grounds for appeal
The grounds for appeal are as follows:
• The CCG has acted beyond its lawful powers
• The decision was one that no other reasonable CCG could have reached.
• The CCG acted unfairly because it did not follow proper procedures (this policy).
• The CCG breached the patient’s human rights.
11.3
How to make an appeal
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In most circumstances it is anticipated that the original applicant (i.e. the referring clinician) would
initiate an appeal. In rare circumstances it may be initiated by a patient, although they would still
need to have the written support of the clinician who made the original application.
Appeals should be made in writing, and clearly labelled “IFR Appeal” to the relevant email address or
postal address given in section 1.
The appeal should be made within 90 days of the date that the original IFR Panel decision was
notified, stating the grounds on which the Appeal is based and submitting any supporting information.
The date of notification is the date of the email or letter. The grounds for appeal must be reasonable
or the case will not be considered by the appeal panel (see section 12.4, below).
11.4
Procedure
The CSU IFR team, taking advice from the CCG Chair of the IFR Panel Committee of the Governing
body where needed, will undertake a preliminary review of the appeal basis to ensure that if new
information is submitted the Appeal is appropriately diverted back to the IFR Panel.
The CSU IFR team will consider the grounds for appeal and make a recommendation to the CCG
Chair of the IFR Panel Committee of the Governing body. If the Chair determines that these are not
reasonable (for example, the applicant merely disagrees with the decision without putting up a
reasonable argument as to why procedure was not followed) then an appeal panel will not be
convened and the applicant will be informed why and of their right to make a complaint under the
complaints process.
In all other circumstances the CSU IFR Team will convene an Appeals Panel meeting as
expeditiously as possible (ideally within 20 working days from receipt of the Appeal). The applicant or
the patient may submit supporting information, however only supporting information relevant to the
grounds for appeal will be considered.
If the applicant considers that there is greater clinical urgency for the Appeal Panel this should be
specified in the Appeal referral letter (sent by secure email) and a phone call to the CSU IFR teams to
alert them to the urgent request.
11.5
Accountability and Membership of the Appeals Panel
The IFR process operates under delegated authority from each CCG Governing body and the
appeals panel will operate as a sub-committee of the full IFR panel although with completely different
membership to ensure a separation of roles and decision-making.
Membership
Chair
• Member of the relevant CCG governing body. Lay member or clinical
Full members
• CCG member – suggested the clinical director (GP), nursing director or
secondary care consultant, not party to the original panel
• Executive Director representative (CSU or CCG)
• Public health representative
Quorum
All full members must be present.
Governance
A sub-committee of the IFR Panel Committee of the CCG Governing body
None of the members will have been involved in the decision-making related to the IFR in question, to
date.
Administrative support to the appeal panel will be provided by the CSU IFR team.
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11.6
4 April 2013
Appeal Panel Decision Making
The Appeal Panel will review all relevant information including:
• the decision-making processes and procedures that informed the original IFR Panel decision,
against the criteria set out in this policy
• the minutes of original IFR panel meeting and the factors taken into account in the original
decision
• any supporting information submitted by the applicant or the patient
The Appeal Panel will assess whether or not the IFR Panel decision:
• was made following the required standards set out in this policy
• took into account all relevant information available at the time
• was reasonable and in line with the evidence
If there is a question about the reasonableness of the IFR decision, the Chair may request additional
expert input.
The outcome of the appeal will either be to uphold the IFR Panel decision appealed against or to refer
the decision back to the original IFR panel in light of the findings of the Appeal.
11.7 Notification of decision
The process and timescale for notification of a decision will be the same as with the IFR Panel. The
letter will detail the grounds for this decision and the circumstances under which the Complaints
Procedure of the responsible CCG may be relevant.
12.
Training
Effective, fair and consistent decision making requires panel and appeal panel members and their
deputies to be trained as well as other CCG and CSU staff directly involved in the IFR process.
Given the complexity of NHS decision-making in the light of emerging case law, appropriate training
will be given to all members of the IFR panels and appeals panels and those within the CSU
responsible for the administration of the process, as well as public health colleagues within local
authorities contributing to the process. The training will include the ethical and legal aspects of
resource allocation. Training will be managed by the CSU IFR team as part of the function which
they undertake on behalf of CCGs.
13.
Monitoring
13.1 Monthly IFR report
A monthly report summarising the case types, approval or rejection for funding, value of the approved
cases and any themes arising from the panel’s work will be sent to the lead CCG member with
delegated responsibility for the IFR process to present at CCG Governing Bodies or Sub-Committees.
The CSU team will be available to present this report as required. The content of this report will be
detailed separately in the CSU KPIs with CCGs.
13.2 Annual IFR report
The annual report will be prepared that summarises commissioning and governance issues. For
example, types of case, volume by CCG and the decisions made, turnaround time, number of
appeals, training. This report will feed into the relevant CCG governing body reporting processes as
appropriate during the transition period to the new commissioning architecture.
14.
Review
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This policy and procedure will be reviewed as required or at the latest by September 2014.
15.
References
[to be added]
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Model Terms of Reference
4 April 2013
Appendix A
Meeting
Individual Funding Requests Panel
Constitution
The Governing Body hereby resolves to establish a Committee of
the Governing Body to be known as the Individual Funding
Requests Panel (the Committee). The Committee is a nonexecutive committee of the Governing Body and has no executive
powers, other than those specifically delegated in the Terms of
Reference.
The purpose of the Committee is to consider and determine eligible
requests for individual funding in accordance with the CCG’s agreed
policy.
• CCG member (panel chair)
• Chief pharmacist/senior medicines management lead
(CSU/CCG)
• Senior contracting representative (CSU/CCG)
• Public health representative
• Patient representative
Role of the
committee
Membership
Members may nominate a suitable deputy if they are unable to
attend, but these must be named in advance and, in order to have
the ability to vote, must be suitably experienced and trained.
Quorum
Meeting
arrangements
Attendees (non-voting)
• Associate CCG representatives (see meeting arrangements
below)
• CSU administrative support
• Pharmacy/medicines management
• Public health
• Contracting
• Any other specialist as requested by the chair as necessary
or beneficial to the decision making process
The quorum shall be XXX members and a duly convened meeting
of the Committee at which a quorum is present shall be competent
to exercise all or any of the authorities, powers and discretions
vested in or exercisable by the Committee.
Meetings of the IFR Panel will be held in common with other CCG’s
IFR Panels in the groupings set out below, which reflect the CSU
point of delivery (POD) structures.
 Barnet, Camden, Enfield, Haringey and Islington
 Barking and Dagenham, Havering and Redbridge
 City and Hackney, Newham, Tower Hamlets and Waltham
Forest
The business to be conducted for each CCG will be clearly
segregated and during consideration of each CCG’s cases the
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members of other CCGs will be in attendance on an associate (nonvoting) basis only.
Frequency of
meetings
Panel meetings will be scheduled regularly to ensure that delay to
decision making is minimised.
Notice of
meetings
Notice of meetings of the Committee shall be forwarded to each
member, and any attendees, no later than XXX working days before
the meeting.
Notice of the meeting shall comprise venue, time and date of the
meeting, together with an agenda of items to be discussed and
supporting papers.
Administration
and minutes of
meetings
The CSU IFR team shall administer and support the Committee,
shall attend to take minutes of the meeting and provide appropriate
support to the Chair and Committee members.
Duties
The Committee shall consider and determine individual funding
requests where the clinical commissioning group is the responsible
commissioner of NHS care.
Reporting
responsibilities
The minutes of the Committee meetings shall be reported to the
Governing Body.
Other
The Committee will ensure that any conflicts of interest are dealt
with in accordance with the NHS Code of Conduct, Code of
Accountability and the CCG’s standing orders.
Meeting
IFR Appeals Panel
Constitution
The Governing Body hereby resolves to establish a sub-committee
of the Individual Funding Requests Panel to be known as the IFR
Appeals Panel (the Appeals Panel). The Appeals Panel is a nonexecutive sub-committee of the Governing Body and has no
executive powers, other than those specifically delegated in the
Terms of Reference.
The purpose of the Appeals Panel is to receive determine whether
due process has been followed in the IFR decision-making process.
• Lay Member (Appeals Panel Chair)
• CCG Governing Body member (nurse or secondary care
clinician)
• Executive Director representative (CSU or CCG)
• Public health representative
None of the members of the Appeals Panel will have been involved
in the decision-making related to the IFR in question.
Role of the
committee
Membership
Attendees (non-voting)
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•
•
Quorum
CSU administrative support
Additional expert input as determined by the Appeals Panel
Chair
The quorum shall be XXX members and a duly convened meeting
of the Appeals Panel at which a quorum is present shall be
competent to exercise all or any of the authorities, powers and
discretions vested in or exercisable by the Appeals Panel.
Frequency of
meetings
Panel meetings will be scheduled regularly to ensure that delay to
the IFR process is minimised.
Notice of
meetings
Notice of meetings of the Appeals Panel shall be forwarded to each
member, and any attendees, no later than XXX working days before
the meeting.
Notice of the meeting shall comprise venue, time and date of the
meeting, together with an agenda of items to be discussed and
supporting papers.
Administration
and minutes of
meetings
The CSU IFR team shall administer and support the Appeals Panel,
shall attend to take minutes of the meeting and provide appropriate
support to the Chair and members.
Duties
The Appeals Panel shall XXXXX
Reporting
responsibilities
The minutes of the Appeals Panel meetings shall be reported to the
Individual Funding Requests Panel.
Other
The Appeals Panel will ensure that any conflicts of interest are dealt
with in accordance with the NHS Code of Conduct, Code of
Accountability and the CCG’s standing orders.
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Section 6.6.3 of Barnet CCG Constitution
4 April 2013
Appendix B
Extracts from the NHS Barnet CCG Constitution
The extracts from the NHS Barnet CCG Constitution is to provide to the Governing Board
and members the change to the constitution as a result of the insertion of the Individual
Funding Request Panel and Individual Funding Request Appeal Panel under Section 6.6.3.
(Committees of the Governing Body)
6.6.3 Committees of the Governing Body - the Governing Body has appointed the
following committees and sub-committees:
a)
Audit Committee – is accountable to the Governing Body and provides
an independent and objective view of the CCG’s financial systems,
financial information and compliance with laws, regulations and directions
governing the CCG in so far as they relate to finance;
b)
Remuneration Committee – is accountable to the Governing Body and
makes recommendations on determinations about the remuneration, fees
and other allowances for employees and for people who provide services
to the CCG and on determinations about allowances under any pension
scheme that the CCG may establish as an alternative to the NHS pension
scheme;
c)
QIPP, Finance and Performance Committee – is accountable to the
Governing Body and provides assurance on finance and performance
ensuring the CCG has the capacity and capability to deliver its
governance duties and responsibilities;
d)
Quality and Clinical Risk Committee – is accountable to the
Governing Body and monitors and provides assurance on quality, clinical
risk and safety issues;
e)
Individual Funding Requests (IFR) Panel – the Individual Funding
Requests Panel is accountable to the group’s governing body and shall
consider and determine individual funding requests in line with the
CCG’s agreed policy. The governing body has approved and keeps
under review the terms of reference for the Individual Funding Requests
Panel, which includes information on the membership of the Individual
Funding Requests Panel.
The Individual Funding Requests Panel shall appoint the following subcommittees to help discharge its duties and powers.
e.1) IFR Appeals Panel - the IFR Appeals Panel reports to the Individual
Funding Requests Panel which approves its terms of reference. Its
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responsibilities include consideration of whether due process has been
followed in the IFR decision-making process.
6.6.4 The Governing Body has approved and keeps under review the terms of reference for
its committees, which include information on the membership of the committees and
which are available via the CCG’s Website.
6.6.5 All committees listed at 6.6.3 above may establish their own sub-committees, to assist
them in discharging their respective responsibilities, with the prior approval of the
Governing Body.
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