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Regional policy for individual funding decisions The attached policy has been developed as part of a collaborative response agreed through the Specialised Commissioning Group (SCG), to the legal duties set out in the Secretary of State’s Directions to PCTs and Trusts, the NHS Constitution, and recently published guidance from the Department of Health. The Directions required all PCTs to have in place, by 1 April 2009, certain arrangements for making decisions on the funding of health care interventions and for making details of those arrangements and decisions available to the public. Interim policies were agreed with SCG in March 2009 and posted on all PCT websites in the region pending development of this more considered and detailed response. At its July meeting, SCG asked for the attached policy to be considered at PCT Boards in September. This paper provides background to its aims and development, and provides clarification on some of the common issues raised in the consultation process. Aims of the policy The policy describes how the Primary Care Trust (PCT) deals with requests for an individual to receive a health care intervention that is not routinely funded by the PCT. These are usually called ‘individual funding requests’ (IFR) but may previously have been referred to as ‘exceptional’ or ‘case-by-case’ requests. The policy aims to provide a common basis for dealing with individual funding requests across the region. As such it provides minimum standards that should be met by all PCTs and that need to be supported by locally agreed procedures. Sections of the attached policy have been highlighted to allow for insertion of additional local information. This policy should be considered in the broader context of how the PCT makes decisions about commissioning health care interventions and the development of ‘general policies’ for specific treatments in specified indications. At present, few PCTs have explicit arrangements for making commissioning decisions about medicines and other treatments, particularly for those medicines excluded from PbR tariff. Development of the policy •

Stock-take of current policies The development of this policy followed a ‘stock-take’ of available policies in the region. This highlighted significant differences between PCTs in areas of policy for individual funding requests, including patient involvement, communication of decisions, and role of appeals panels. Providing a standard approach to these important issues was key to the development of this common policy.

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Consultation process A draft policy was developed based on the interim IFR policy agreed with SCG in March 2009. Further detail was added based on an understanding of existing policies together with national and local guidance. A first draft for comment was circulated to all PCT Chief Executives and Commissioning Leads on 12th June with a revised draft circulated on 16th July. A paper supporting the common policy was discussed at the meeting of SCG on 17th July and the policy agreed, subject to final comments on matters of substance by 24th July, for submission to PCT boards in September.

Legal advice Legal advice on the initial and revised drafts of the policy was obtained from Beachcrofts. No further substantive changes have been made to the policy following consideration of their advice although minor amendments and clarifications have been made following final comments from PCTs.

Legal advice focussed on the following three key aspects of the policy: a) the IFR process comprises three key stages: triage, IFR, appeal. Each requires appropriate resourcing with particular emphasis on triage to ensure that only those requests that truly need an individual funding decision are passed to the IFR panel and that such requests are made in a timely way in full knowledge of all supporting information. b) processes should be transparent and explicit with patients allowed access to the clinical information available to the IFR Panel considering the request. Furthermore, as far as possible, Panels should be ‘even-handed’ with clear identification of the ‘advisors’ and the ‘decision-makers’. This is even more important at an Appeals Panel, which should provide a procedural review based on a full set of papers and with representation from the PCT only if the patient or representative is also given the opportunity to be present. c) If the PCT decides to refuse a request to fund a health care intervention for an individual, where the PCT’s general policy is not to fund that treatment, the PCT must provide the patient with a written statement of the reasons for the decision. • Decision-making seminar The SHA and SCG co-hosted a seminar on 30th July, which was attended by representatives from almost all PCTs and acute providers in the region. The seminar aimed to make organisations aware of the national and regional developments in the Department of Health sponsored ‘decision-making’ work programme. In addition, the seminar provided an opportunity for localities to review existing arrangement for decision-making and how these can be developed in light of national guidance. Individual funding requests should be a small part of this broader work but currently require significant resources at both Trusts and PCTs.

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Common issues raised during consultation

1) Do we have to communicate directly with patients? •

The Directions from the Secretary of State require the PCT to provide the patient with a written statement of reasons if it refuses to fund a health care intervention for the individual, where the PCT’s general policy is not to fund that treatment. How this statement is delivered to the patient is for local procedure and may, for example, involve local agreement to inform patients via the requesting clinician. However, such an arrangement should be explicit and does not remove responsibility from the PCT should the clinician not pass on the information.

2) Is there a standard IFR request form? •

A draft standard IFR form was circulated for comment but cannot easily be incorporated in to current local processes. However, a standard dataset of information that should be submitted and considered for each IFR has been developed based on comments received and will be circulated with the IFR common policy. PCTs may choose to adopt a single form for a locality based on this information or work with providers to ensure that this information is incorporated into existing forms.

3) Can the patient attend an Appeal Panel meeting? •

National guidance states that the process should be ‘open’ to patients, meaning that the process should be transparent with the opportunity for patients, and their representatives, to submit information. There is no right for patients to attend a Panel meeting but their attendance may, in exceptional circumstances, be considered by the Panel to be helpful.

4) Does the policy only apply to medicines? •

The policy covers ‘health care interventions’ to reflect, and as defined by, the Secretary of State’s Directions. It, therefore, covers a broad range of interventions other than medicines. It is important to note that what some PCTs currently describe as IFRs, typically for certain surgical interventions, are better described as ‘prior approvals’ since they require consideration of an individual’s clinical condition against an existing general policy and criteria for that intervention. Where possible, the development and implementation of explicit general policies together with audit should be used instead of ‘prior approval’.

5) Who triages requests? •

This is for local agreement based on available resources but triage is not a decision-making step in itself. The basic function of the triage process is to direct requests along the appropriate decision-making pathway and ensure that all relevant information is received to enable a decision to be made. Triage should not be confused with ‘prior approval’ of requests as different skills and resources will be required for each function.

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