[        ] PRIMARY CARE TRUST (1)

AND

[       ] NHS Trust (2)

AGREEMENT FOR THE PROVISION OF HEALTH SERVICES

CONTENTS

1.	DURATION, CONDITIONS PRECEDENT, THE COMMISSIONER AND ITS ASSOCIATES
2.	THE SERVICES
3.	PRICES AND PAYMENT
4.	DEMAND MANAGEMENT, CARE AND UTILISATION TECHNIQUES AND RETENTION OF PAYMENT SCHEME
5.	PATIENT BOOKING AND PATIENT CHOICE
6.	NATIONAL AND LOCALLY AGREED QUALITY STANDARDS
7.	INFORMATION FLOWS AND RECORDS AND REPORTING PROVISIONS 
8.	SERVICE IMPROVEMENT, BUSINESS CONTINUITY, DUTY OF PARTNERSHIP
9.	MONITORING AND PERFORMANCE MANAGEMENT
10.	DISPUTE RESOLUTION PROCEDURE
11.	NHS BRANDING AND PROMOTION
	APPENDICES

PARTIES

1	[                    ] Primary Care Trust whose principal office is at [                    ] (the "Commissioner") 

2	[                    ] NHS Trust whose principal office is at [                    ] (the "Provider") 

GUIDING PRINCIPLES

The Parties agree to have regard to the published statement of NHS Principles,  announced by the Secretary or State and amended from time to time.

1.	Duration, Conditions Precedent, THE COMMISSIONER and ITS ASSOCIATES
1.1	This Agreement shall take effect from the Commencement Date (1 April 2007) and during the period of [1] Contract Year.
1.2	Before the commencement date the commissioner will agree with the provider monthly forecast levels of activity for both elective and non-elective care, the “activity plan”, outlined in Clause 4 and Annex 1. The Commissioner shall also have delivered to the Provider the documents referred to in Clauses 1.2.1 and 1.2.2 unless the requirement to deliver any such documents is waived by the Provider giving written notice to the Commissioner:
1.2.1	an executed copy of its commissioning intentions; 
1.2.2	an executed copy of the Consortium Agreement (or Consortia Agreements)
1.3	The Commissioner and the Provider mutually agree that the Commissioner enters into this Agreement as a ‘Co-ordinating Commissioner’;
1.3.1	as principal for itself in respect of the Services to be provided and the prices to be paid which are severally appropriated to it;
1.3.2	as agent for each one of its Associates as separate principals in respect of the Services to be provided and the prices to be paid which are severally appropriated to that Associate.
1.4	To avoid doubt neither the Co-ordinating Commissioner nor any one of its Associates shall have any rights or liabilities, whether jointly or severally, under any of the Schedules 1 or 2 which do not bear its name, relating to any of the Services to be provided or for any of the prices to be paid under any of such Schedules.
1.5	The named Co-ordinating Commissioner shall act for itself and as agent for the Co-ordinating Commissioner and all its Associates, for the purposes indicated in Clauses 2 to 10, and all the Schedules.
2.	THE SERVICES 
2.1	The Provider shall provide the Services needed by each Patient of the Commissioner and its Associates who is referred or presents to the Provider in accordance with this Agreement, and in accordance with, but not limited to, the Service Specifications, the Activity Plan, Booked Services and the Quality requirements, except those:
2.1.1	who are unsuitable for treatment under the Services, according to Good Clinical Practice;
2.1.2	who are temporarily unsuitable for treatment under the Services, according to Good Clinical Practice for as long as such unsuitability remains;
2.1.3	who have not validly consented and were able to do so, or not had consent validly given on their behalf where it could have been, to the treatment provided under the Services; and
2.1.4	for any unreasonable behaviour unacceptable to the Provider, its Staff or the Consultant clinically responsible for the management of the care of such Patient (having regard to the Provider's zero-tolerance policy from time to time in issue) notwithstanding that the judgements in those cases must take into account the mental health of such Patients.
2.2	Where the Provider proposes to refuse to provide or continue to provide the Services to any Patient, the Provider shall explain to the Patient:
2.2.1	the action that it is taking and the reasons for such action, following up any oral explanations in writing within one Operational Day; and
2.2.2	that the Patient has the right to challenge the Provider's decision through any relevant complaints procedure.
2.3	Where appropriate the Commissioner or its Associate concerned, and the Provider shall use all reasonable endeavours, including discussions with the Patient and/or where appropriate the Patient's GP, to resolve the issue of the treatment of the Patient in a way which minimises any disruption to the Patient's care.  Where those Parties cannot agree about the Provider's treatment of the Patient, the Provider shall (subject to any discharge requirements) notify the Commissioner that it will discontinue treatment of that Patient and the Commissioner or its Associate shall use its reasonable endeavours to procure  alternative treatment for that Patient.
2.4	The Provider shall not:
2.4.1	refuse or withhold any treatment which is urgently required by, and is in the best interests of any Patient, or
2.4.2	refuse or withhold any treatment on the grounds of the behaviour of any person other than the Patient.
2.5	The Provider undertakes to avoid carrying out, or referring to another service within the Provider, or to another Provider to carry out, any additional non-urgent or routine treatment that is unrelated to a Patient's original referral or presentation without first referring the matter to the Patient's GP. This is further explained in Paragraph 2.5.1
2.5.1	Any patient requiring referral from one specialty to another or from one hospital practitioner to another which would result in the scheduling of a new outpatient attendance (as defined by most recent Payments by Results guidance issued by the Department of Health) will instead be referred back to his or her general practitioner with appropriate advice to effect an onward referral, except as defined in 2.5.2

2.5.2 Paragraph 2.5.1 will not apply in the following circumstances:-

(i)	Where such referral is urgent.  Such referrals would be expected to be completed in line with the prevailing waiting times for urgent referrals.

(ii)	All referrals made in relation to cancer or suspected cancer.

(iii)	All referrals which are a consequence of a universally accepted pathway relating to the patients’ presenting condition.  Examples of these are cardiac presentations requiring surgical or cardiological intervention, renal presentations requiring vascular access surgery or referral for anaesthetic opinion as part of pre-operative assessment 

2.6	The Provider shall be paid for activity under any of the Services provided to any Patient prior to such Patient being refused treatment and discharged, unless such activity requires rectification by another provider.
3.	PRICES AND PAYMENT
3.1	Prices
3.2	The Commissioner and its Associates shall pay the Provider, for all activity delivered to them, prices calculated in accordance with:
3.2.1	National Tariff for all Services (as defined in the Department of Health guidance) to which the National Tariff applies
3.2.2	the Code of Conduct for Payment by Results; the Implementation Support Guide for Payment by Results and the Operation of Secondary Uses Services (SUS) to support Payment by Results;
3.2.3	the Activity Plan as agreed (attached Annex 1)
3.2.4	the Prior Approval and Utilisation Management Schemes in accordance with Annex 2; and
3.2.5	Good Healthcare and Good Clinical Practice.
3.3	For Services to which the National Tariff does not apply:
3.3.1	the Services Prices shall be fixed by agreement between the Co-ordinating Commissioner and the Provider on the basis of the costs incurred for the purposes of providing the Services
3.3.1.1		wages and salaries constituting a direct charge to the work to be performed;
3.3.1.2		materials and bought supplies and instruments; and
3.3.1.3	  overhead and administration charges appropriate to the Services
3.3.2	the calculation of the Provider’s Prices for Services shall be transparent, equitable and open to revision annually by Review.
3.3.3	In the event that no agreement can be reached on the Services Prices, they will be calculated in accordance with the price payable for services of the same or similar nature in the preceding Contract Year, multiplied by any National Tariff Uplift applying to the Contract Year.
 
3.3.4	The Commissioner shall continue to make payments to the Provider on the basis that the Service Price in dispute has been calculated in accordance with clauses 3.3.1 or 3.3.3, until the dispute is resolved.

3.4	Payment process
3.5	Payments will, in the first instance, be made in 12 equal monthly payments, equalling the contract value, and due on the [15th] of each month.
3.6	The Co-ordinating Commissioner will prepare a Reconciliation Account each Quarter, on behalf of itself and its Associates, based on actual activity for the Quarter, based on information supplied by the Provider.
3.7	The Reconciliation Account should be sent to the Provider within [5] Operational Days of the Freeze Date for the Quarter to which it applies, and be agreed or disputed in writing by the Provider within 5 Operational Days of being issued.
3.8	Once the Reconciliation Account is agreed, a reconciliation payment is to be made within 5 Operational Days of agreement. If part of the Reconciliation Account is disputed, then payment should be made for that part not in dispute within 5 Operational Days.
3.9	The reconciliation payment will be made on the basis of information received up to a maximum of 10 weeks from the end of the Quarter to which the payment applies. Any corrections made after that time will not be taken into account.
3.10	The Commissioner will not pay for treatment needed to rectify performance or omission by the Provider, and if such treatment needs to be carried out by the Commissioner, or procured from another Provider, the Commissioner is entitled to recover the cost from the Provider.
3.11	If the Reconciliation Account is disputed, the Parties will resort to the Dispute Resolution Procedure. Any payment determined by the Dispute Resolution Procedure will be paid with interest, calculated on a day-to-day basis at a rate per annum equivalent to the Default Interest Rate from the day after payment was due up to and including the date of payment.
4.	the activity plan, CARE AND RESOURCE UTILISATION TECHNIQUES AND RETENTION OF PAYMENT SCHEME.
4.1	General 
4.2	Both parties have a mutual responsibility to respond to the health needs of their populations. They shall co-operate with each other with the intent that the Activity Plan is consistently monitored and reviewed so as to reflect the changing health needs of their populations; changes in the distribution profile of activity and casemix; any innovative treatment or clinical practice recommended by a relevant or clinical network. 
The Co-ordinating Commissioner has a responsibility to manage demand for all the Services.  
The Provider has a responsibility to assess capacity to respond to this demand such that any referral made by a Referring Practitioner and accepted by the Provider (subject always to any relevant Prior Approval Scheme) is assessed and treated within the time limits set out in the Agreement. 
Both parties have a duty to monitor actual demand against forecast levels in accordance with this agreement, and to act in accordance with their respective and mutual responsibilities.  
4.3	The parties acknowledge the Activity Plan is essential to the effective operation of the Agreement and shall reflect key national priorities and achievement of national performance standards.  The Activity Plan will ensure patients receive the most appropriate care in the right setting, ensuring that healthcare resources are maximised.  
4.4	The Provider has agreed to manage the provision of the services in accordance with delivery of the 18 weeks Referral-to-Treatment Target.  For the avoidance of doubt this is the commitment of the NHS that: during March 2008, admitted treatment starts within 18 Weeks of being referred for at least 85% of admitted patients and for other patients subject to the target, the figure is at least 90%; and that by 1 January 2009 no NHS patient will wait longer than 18 weeks from Referring Practitioner to hospital treatment.  The pathways and rules governing measurement, suspensions of the waiting time clock and clinical exceptions are detailed in DoH guidance “Tackling hospital waiting: the 18 week patient pathway – an implementation framework”, published in May 2006 (“the 18 Week Guidance”).  

4.5	Implementation 
4.6	During the Transitional Period, the Co-ordinating Commissioner shall submit to the Provider its proposals (“the Co-ordinating Commissioner Proposals”) for a draft of the Activity Plan which, without limitation, shall comprise the following: 
4.6.1	the Activity Profile for the next Contract Year (other than in the first Contract Year) which shall include all the matters referred to in Paragraph 4.10.
4.6.2	Care and Resource Utilisation agreements, including Prior Approval and Utilisation Management Schemes which shall comply with the principles described in the Care and resource Utilisation guidance.
4.7	Within 5 Operational Days of receipt of the Co-ordinating Commissioner Proposals the Provider shall either submit:
4.7.1	its own proposals on the Activity Plan (“the Provider Proposals”); or
4.7.2	its written acceptance of the Activity Plan within 5 Operational Days of receipt of the Provider Proposals    
4.8	The Co-ordinating Commissioner shall either: 
4.8.1	offer its written acceptance to the Provider Proposals (including its acceptance of the methodology used) in which case they shall stand as the Activity Plan; or 
4.8.2	reject the Provider Proposals with reasons in writing for the rejection and on [  ] written notice to that effect convene a meeting (“the Determination Panel”) of the parties’ respective Chief Executives, Directors of Finance and Medical Directors or Officers of equal standing and authority with the intent that agreement on the final form of the Activity Plan is reached before the 28 February in any Contract year. 
4.8.3	The Determination Panel shall, before reaching its determination, review:
4.8.3.1	the Co-ordinating Commissioner’s Proposals and its reasons for rejection of the same; 
4.8.3.2	the Provider’s Proposals;
4.8.3.3	the Local Delivery Plan and the Commissioning Intentions; 
4.8.3.4	the Provider’s Annual Plan and monthly activity profile (as more particularly described in Paragraph 4.6) for the preceding Contract Year or year in the instance of the first Contract Year.
4.9	If the parties are unable to agree on any of the terms of the Activity Plan by 28 February in each Contract Year the terms of the Dispute Resolution Procedure set out in Clause 10 of this agreement will apply. 
4.10	Activity Profile and Thresholds for Review 
4.11	The Activity Profile shall comprise: 
4.11.1	monthly forecast levels of activity necessary for the Provider to meet the forecast levels of demand, both non-elective and elective, and to achieve the 18w performance milestones for referral-to-treatment times as more particularly described in the 18 Week Guidance;   
4.11.2	each type of activity forecast at specialty level (Co-ordinating Commissioners and Providers may agree to specify activity forecasts for specified HRGs in the Activity Profile or for specified Treatment Functions or for specified HRG chapters);  
4.11.3	activity forecasts for  the largest specialities individually; together with activity forecasts for a specialities group, or groups, comprising the forecast activity for those specialties which are not specified individually;  
4.11.4	 All commissioned activity must be included in the Activity Profile and pages should be added to the Activity Profile to cover activity outside the scope of Payment by Results.
4.11.5	The Provider and Co-ordinating Commissioner shall agree forecast average cost per unit of activity using the preceding Year or Contract Year (as the context so admits) outturn average cost per unit of activity as the basis for the forecast average cost per unit of activity. This will provide the basis for comparing the costs of actual and expected activity. 
4.11.6	The benchmark for the Commissioned activity sufficient to deliver 18 Weeks Referral-to-Treatment Target shall  be the Activity profile of elective care based on expected volumes of new referrals and the reduction required in existing waiting lists described in the LDP for the next Contract Year and for non-elective care shall be the profile of Activity specified in the LDP having as its basis the outturn non-elective Activity for the preceding Contract Year or Year (as the context so admits).   
4.11.7	The Activity Profile will specify each type of activity being commissioned, including: emergency spells; other spells; A&E attendances; elective spells; excess bed days; first outpatient attendances, consultant-led; first outpatient attendances following GP referral, consultant-led; first outpatient attendances, non-consultant-led; subsequent outpatient attendances, consultant-led; subsequent outpatient attendances, non-consultant-led; procedures in outpatients; diagnostics tests and procedures. 
4.11.8	The Activity Profile will additionally specify forecast monthly levels of: GP referrals to outpatients; consultant-to-consultant referrals; other referrals to outpatients; conversion rates for A&E admissions; outpatient conversion rates and the ratio of subsequent to first outpatient attendances. 
4.12	The Activity Profile will additionally specify planned levels of performance on Referral to Treatment times each month, including the percentage of patients whose 18 Week clock stopped during each month who waited 18 Weeks or less, both for admitted patients and for non-admitted patients. 
4.13	The Activity Profile will also specify planned levels of performance on total waiting list, and long waiters at the end of each month, for: inpatient waiting list; outpatient waiting list; diagnostics waiting list. 
4.14	The Commissioner shall specify a forecast threshold for each Activity in the Activity Plan, to function as an early warning of where the actual level of demand exceeds the forecast threshold with the intent that any breach of the forecast threshold will be reviewed by the Parties at the monthly review meeting next following the breach.  Forecast thresholds shall also be set for the metrics in the Activity Plan, including conversion rates and unit costs at either HRG, specialty or sub-specialty level depending upon the anticipated volume of activity for the Activity so that, by way of example only, a high volume activity will have a forecast threshold set at HRG level.
4.15	The breach point of any forecast threshold shall be the point in time at which the actual Activity exceeds the forecast threshold. The Provider shall notify the Co-ordinating Commissioner of a breach of the forecast threshold as soon as practicable. The forecast threshold shall, for each Activity, be the outturn Activity for the preceding Year or Contract Year (as the context so admits), adjusted by the Co-ordinating Commissioner so that the 18 Week Referral-to-Treatment Target is achieved for that Activity in the Contract Year in which it will be undertaken. 
4.16	The Activity Profile shall comprise the aggregated Activity Profile of all Associate PCTs and also each individual Profile for each Associate. 
4.17	Care and Resource Utilisation (Demand Management) 
4.18	For its part and pursuant to Clause 4.49 (duty of co-operation) the Co-ordinating Commissioner agrees: 
4.18.1	to manage demand for all the Services (including Booked Services and Choice Services) via Referring Practitioners to the forecast thresholds set out in the Activity Plan – (except for, and to the extent of any change in demand for Choice Services as anticipated in Clause 5) and will use all reasonable endeavours to notify the Provider within 5 days of receiving any information demonstrating any anticipated changes in such numbers of referrals; 
4.18.2	to require that its agents and practitioners shall adhere to any referral and treatment protocols as may be agreed between the Parties;  
4.18.3	to comply with Paragraph 4.24 of this agreement whether at individual patient or group patient level.  
4.19	For its part the Provider agrees to manage demand for all the Services in accordance with the Activity Plan and the provisions of Clause 4. 
4.19.1	to manage conversion rates and follow ups by specialty to such levels as set out in the Activity Plan 
4.19.2	to keep under review internal Consultant to Consultant referrals to such levels as may be set out within the Activity Profile  
4.19.3	to comply with the reasonable requests of the Co-ordinating  Commissioner to assist the Co-ordinating Commissioner in understanding and managing referrals where activity profiling and monitoring forecasts over-performance; and
4.19.4	to require that its agents and employees shall adhere to any referral and treatment protocols as may be agreed between the Parties 
4.20	The Provider may refuse to accept any referral of a Patient that it considers Clinically Inappropriate for acceptance as a referral to itself as the Provider of the Services and in such cases will refer the matter back to the Patient’s GP. The provider and commissioner are expected at all times to act in the best interests of the patient
4.21	Implementation of Prior Approval and Utilisation Management Schemes
4.22	When implementing Prior Approval and Utilisation Management Schemes the Provider and Co-ordinating Commissioner shall adhere to the principles published in the Care and Resource Utilisation guidance.  
4.23	It is acknowledged by the Parties that Prior Approval Schemes shall, in the main, be applied to patient groups so as to avoid the Provider being subject to an unnecessary administrative burden in administering any Prior Approval Scheme for each and every individual Patient referred to it. It is acknowledged and agreed by the Parties that Prior Approval Schemes for Individual Patients shall only be implemented by the Co-ordinating Commissioner in circumstances to be agreed with the Provider, and in any event no Individual Patient Prior Approval Scheme shall be implemented by a Co-ordinating Commissioner unless it has first been trialled for no less than (one) month by the Provider and thereafter the findings of the said trial shall be incorporated into the Individual Patient Prior Approval Scheme before it is implemented by the Co-ordinating Commissioner.
4.24	Prior to the implementation of any Prior Approval Scheme or Utilisation Management Scheme the Co-ordinating Commissioner shall give notice of any proposal to implement a Prior Approval Scheme or Utilisation Management Scheme to the Provider with the intent that the Co-ordinating Commissioner and the Provider (or their duly authorised representatives) promptly meet so as to:
4.24.1	review the proposal;
4.24.2	receive the opinion or recommendations of any clinical network; and
4.24.3	thereafter, on reasonable notice from the Co-ordinating Commissioner to the Provider to implement the Prior Approval Scheme.
4.25	If a Prior Approval Scheme and/or a Utilisation Management Scheme is established, then the Provider shall use all reasonable endeavours to comply with the said Schemes in the form subsequently annexed to this agreement as Annex 1:
4.26	Prior Approval
4.27	For individual patients or on an identified group of patients, Providers will manage patients in accordance with the terms of the relevant Prior Approval Schemes. Providers will manage activity covered by the Prior Approval Schemes  and the Provider and the Co-ordinating Commissioner shall have regard to and take account of any increase or decrease in Activity arising in consequence of the implementation of the relevant (to the Activity) Prior Approval Scheme:  
4.28	For Prior Approval on individual patients or on an identified group of patients, Co-ordinating Commissioners will; 
4.28.1	set out where such Prior Approval is required; 
4.28.2	require that where the 18 Week Referral-to-Treatment Target is at risk for any Activity the subject of a Prior Approval Scheme the Provider shall specify a Basic Pathway (as described in paragraph 4.60.9); and 
4.28.3	require that the timeline within which the Prior Approval shall be given shall be no more than 3 Operational Days from the date of referral by the Provider, once the required information has been provided. Time shall be of the essence. A failure to respond to a request for approval within the period referred to shall be deemed to be an approval for the relevant Prior Approval Scheme for the patient the subject of the same. 
4.28.4	In exceptional circumstances, the Co-ordinating Commissioner may take longer than the 3 Operational Days referred to in paragraph 4.28.3 above to respond to a request for approval but in such circumstances the Co-ordinating Commissioner should:
4.28.4.1	notify the Provider within 3 Operational Days from the date of referral by the Provider that they are unable to respond to a request for approval for the relevant Prior Approval Scheme, detail the reasons why and the date by which they will be able to respond; 
4.28.4.2	require that where the 18 Week Referral-to-Treatment Target is at risk of breach for any Activity the subject of a Prior Approval Scheme, the parties shall amend the Basic Pathway (as described in Paragraph 4.60.9) to take account of the prior approval timetable, the subject of 4.28.4: 
4.29	 In the instance of urgent clinical need or risk to patient safety the Co-ordinating Commissioner shall grant retrospective approval for the [Activity] comprised within the referral to treatment pathway for the Patient for whom retrospective approval is sought. 
4.30	The Co-ordinating Commissioner will give the Provider one month notice in writing of any changes or additions to any Prior Approval scheme. 
4.31	Utilisation Management 
4.32	The Provider shall comply with any Utilisation Management schemes implemented by the Co-ordinating Commissioner which will be consistent with the general principles of the Care and Resource Utilisation guidance and the Provider shall implement them  in accordance with the terms of any reasonable notice to that effect from the Co-ordinating Commissioner:
4.33	The Provider will co-operate with the Utilisation Management Schemes (in particular to share data, allow access for review teams and access to patient notes). 
4.34	The Co-ordinating Commissioner will give the Provider 1 months notice in writing of any variation to the Utilisation Management scheme which the Provider shall then comply with. 
4.35	Monitoring and Reporting of Activity 
4.36	The Provider shall submit actual activity, referrals, conversion rates and patients waiting against the Activity Profile on a monthly basis in the form of the agreed  report included in Appendix 2, and shall, in any event promptly: 
4.36.1	notify the Co-ordinating Commissioner’s Representative if the Provider forecasts that there will be over-performance of Non-elective Care activity in any of the Services compared to the levels set out in the Activity Plan 
4.36.2	notify the Co-ordinating Commissioner’s Representative if the Provider forecasts that there will be over-performance of Elective Care activity in any of the Services against any maximum waiting time targets specified under the Activity Plan, or forecast activity specified under the Activity Plan; and 
4.36.3	notify the Co-ordinating Commissioner’s Representative of any increase or decrease in Choice Service activity against any indicative levels as may be specified in the Activity Plan. 
The Provider Representative and the Co-ordinating Commissioner Representative may meet to review: 
4.37.1	the monthly activity since the start of the  Year;
4.37.2	any actual or anticipated changes in demand, having regard to the monthly activity since the start of the Year;
4.37.3	any breach of the thresholds specified in the Activity Profile;
4.37.4	any breach of a Prior Approval Scheme;
4.37.5	the average cost per unit of Activity; 
4.37.6	a failure to co-operate with the Co-ordinating Commissioner in relation to the implementation and application of a Utilisation Management Scheme; and
4.37.7	whether or not any Activity should be the subject of Remedial Action Plan or Capacity Review in the form and manner set out in paragraphs 4.32 and 4.45 below.  
4.38	Capacity Review 
4.39	In the circumstances where the Provider acting reasonably, and having regard to the monthly profile for the relevant Activity and any significant increase in demand in that profile, which is likely to arise in the Contract Year, considers that it will be unable to meet the 18 Week Referral-to-Treatment Target then, on 5 Operational Days notice to the Co-ordinating Commissioner it shall require the Co-ordinating Commissioner to undertake a review of the Activity specified in the said Notice (“the Capacity Review”).
4.40	The Co-ordinating Commissioner shall commence the Capacity Review within 10 Operational Days of receipt of the said Notice. 
4.41	The Capacity Review shall consider:
4.41.1	any constraints on the physical capacity or resources, including, staff of the Provider; and  
4.41.2	whether the Provider is delivering the most efficient care pathways for the Activity (the subject of this review) as informed by Good Healthcare Practice.
4.42	The Co-ordinating Commissioner shall, upon conclusion of the Capacity Review, report its findings and any recommendations to the Provider.
4.43	If the findings of the Capacity Review find that there is a limit on the Activity the Provider can reasonably undertake so as to achieve the 18 Week Referral-to-Treatment Target then the recommendations of the Co-ordinating Commissioner shall include a recommendation to the effect that:
4.43.1	the Activity is suspended from the 18 Week Referral-to-Treatment Target (“the Suspended Activity”); and 
4.43.2	the Provider shall not be made the subject of any financial adjustment pursuant to paragraph 4.53 during the period that the Activity is so suspended.
4.44	The Provider and the Co-ordinating Commissioner shall keep under review the findings and recommendations of the Capacity Review with the intention that Suspended Activity is made the subject of the 18 Week Referral-to-Treatment Target as soon as the Provider and the Co-ordinating Commissioner shall agree. 
4.45	Remedial Action following variations in Activity 
4.46	Without prejudice to paragraphs 4.35 and 4.38, if the forecast threshold for any Activity is breached; or where the Prior Approval and/or Utilisation Management Schemes have been breached; then either party may on 5 days of notice to the other:
4.46.1	propose a Remedial Action Plan consisting of, without limitation, such matters as are  referred to within Paragraph 4.47 below; and/or
4.46.2	require the Party in breach  to review the breaches and to submit its proposals to remedy any breaches that are identified in the Remedial Action Plan within 5 Operational Days of receipt of the Notice; 
4.47	The Remedial Action Plan may include an analysis of the following matters for the period in which a forecast threshold has been breached:
4.47.1	primary, secondary and tertiary referrals;
4.47.2	conversion rates;
4.47.3	activity levels;
4.47.4	waiting list volumes for patients within the category of the breach forecast threshold;
4.47.5	right-coding;
4.47.6	unit cost.
4.48	The Co-ordinating Commissioner shall monitor primary care capacity where care has been shifted to a primary care-delivered pathway and shall make Variations to the Activity Plan as are consistent with the change in capacity.  
4.49	The Provider undertakes to work collaboratively with the Co-ordinating Commissioner on the development, implementation and operation of service redesign programmes; actively engaging with, supporting, and cooperating with redesign, recording and coding policies, and demand management activities as deemed necessary in the Remedial Action Plan.  The Remedial Action Plan shall specify any thresholds which have been breached, and the Party in breach shall make proposals to remedy the relevant breach including its findings in relation to a review of any of the following insofar as they relate to the breach.  
4.50	The Remedial Action Plan will include specific locally agreed targets and timescales within which targets shall be achieved.
4.51	If within 5 days of any breach by the Provider of the Remedial Action Plan or a failure to implement the same subject to its rights of dispute not having been exercised, then the Co-ordinating Commissioner acting reasonably, may in its absolute discretion (without prejudice to any other express rights of the Co-ordinating Commissioner under this Agreement) require the Provider by written notice to take such steps as the Co-ordinating Commissioner considers necessary or expedient to mitigate or rectify the breach and the Provider shall use all reasonable endeavours to comply with the Co-ordinating Commissioner’s requirements as soon as reasonably practicable.
4.52	If the Provider does not confirm, within ten (10) Operational Days of a notice served pursuant to paragraph 4.51 (or such shorter period as the Co-ordinating Commissioner, acting reasonably, determines is appropriate in the relevant circumstances), that:
4.52.1	it is willing to take such steps referred to in paragraph 4.51; or
4.52.2	the Provider fails to take the steps notified to it by the Co-ordinating Commissioner pursuant to paragraph 4.51 within such time as the Co-ordinating Commissioner, acting reasonably, shall think fit.
4.52.3	then the provisions of clause 4.53 will apply (without prejudice to clause 3 of the Agreement). 
4.53	Financial Adjustment for Variations in Activity 
4.54	No later than 30 Operational Days from the end of the Year, the Co-ordinating Commissioner shall initiate a joint process with the Provider to determine whether any financial adjustment should be applied in relation to any Activity which has in the Contract Year breached forecast thresholds and:
4.54.1	which has been the subject of a Remedial Action Plan, notwithstanding which the Activity has exceeded the forecast threshold; or 
4.54.2	which has breached a Prior Approval scheme; or
4.55	Initiation of this joint process is at the discretion of the Commissioner, and may, for example relate to excess activity relating to :
4.55.1	waiting list volumes being reduced below agreed levels;
4.55.2	conversion rates exceeding agreed upper limits;
4.55.3	ratios of subsequent to first outpatient attendances exceeding agreed upper limits;
4.55.4	rates of consultant-to-consultant referrals exceeding agreed upper limits.
4.56	For any over-activity which is determined to be the Provider’s responsibility then the Provider will not be paid by the Co-ordinating Commissioner for any Activity above the forecast threshold [or above the forecast conversion rate] which Activity was undertaken immediately after the confirmation deadline referred to in paragraph 4.52, or in relation to paragraph 4.54.2, the date from which the breach occurred.
4.57	Delivery of The 18 weeks Referral-to-Treatment Target
4.58	No later than 30 September 2007, the Parties shall agree specified symptom-based patient pathways with Providers for HRGs.  For multi-Provider care pathways (e.g. pathways which include referrals from secondary care to tertiary care) the specified pathway will split accountability across Providers for different stages of the pathway.
4.59	The level of detail for symptom-based patient pathways shall be informed by good practice issued by the Department of Health. 
4.60	The actual patient pathways that are included in the contract and their level of detail should be determined locally based on the level of risk to delivery of 18w.  Each pathway will need to be specified by the commissioner at one of three levels set out below:
4.60.1	Detailed pathways will include:
4.60.2	an agreed patient pathway of each significant step from initial patient presentation to GP through to diagnosis (including direct access and straight to test) to treatment and/or discharge;
4.60.3	detailed definitions of each Provider's responsibilities for multi-Provider pathways;
4.60.4	clinical protocols and timings for each stage of the pathway;
4.60.5	Outline pathways will include:
4.60.6	an agreed pathway covering most significant steps of the pathway;
4.60.7	outline definitions of each Provider's responsibilities for multi-Provider pathways;
4.60.8	outline clinical protocols for the pathway.
4.60.9	Basic pathways will be included in an agreed list of multi-Provider pathways that have not been specified at a detailed outline level.
4.61	Financial adjustments for 18 weeks performance 
4.62	The Co-ordinating Commissioner may make financial adjustments to payments due to the Provider based on performance against the 18 Weeks Referral-to-Treatment milestone or Target (as the context so admits having regard to the 18 Week Guidance) applicable in the relevant year.
4.63	Any financial year adjustment at the end of Year 2007/8 will apply to total elective income for that year based on actual performance against the (March 2008 18w milestones) reported for March 2008.
4.64	Any financial adjustments at the end of Year 2008/9 will be based on actual performance against the December 2008 18 Week Referral-to-Treatment Target as measured in January 2009 and continued performance in February and March 2009.  Adjustments will apply to total elective income in the ten months up to and including January 2009 based on performance measured in January 2009. Adjustments will apply to the total elective income for February and March 2009 based on overall performance measured across those two months.
4.65	The necessity for financial adjustments based on 18 Week performance beyond 2008/09 will be reviewed in 2008/09. 
4.66	During the year, there will be formal monitoring points at the end of each financial month.  Co-ordinating Commissioners and provider should agree an anticipated year-end position for performance against the 18 Week Referral-to-Treatment  milestone/target.  Financial adjustments should be estimated on this basis and agreed, and provision made in the accounts of both Co-ordinating Commissioner and provider accordingly. Where it is anticipated that the year end position would not achieve the 18 Week Referral-to-Treatment milestone/target, Co-ordinating Commissioners and Providers shall agree a Remedial Action Plan. 
4.67	Anticipated performance should be based on the best local data available at the end of the month.  The Provider’s monthly Referral-to-Treatment data should be available to the Co-ordinating Commissioner within a month (as detailed in Clause 7).  This data may also be used to estimate elective activity value for activity to date.  
4.68	Cash flow from the Co-ordinating Commissioner to the provider during Q4 should anticipate the impending year-end income position. 
4.69	The actual year-end financial adjustment in terms of income reflected in final accounts will be subject to the official “RTT waiting time data”, available [6] weeks after 31 March.
4.70	A financial adjustment of a 0.5% deduction in total elective income will be applied for each 1% by which the provider underachieves the 18 Week Referral-to-Treatment milestone or target.  The adjustment will be capped at a maximum of 5% of total elective income applied if the provider underachieves the 18 Week Referral-to-Treatment milestone or target by 10% or more.  
4.71	Financial adjustments will be weighted based on performance against the separate 18 Week Referral-to-Treatment milestones and targets for admitted and non-admitted patients.  Adjustments relating to performance for admitted care will apply to 75% of total elective income.  Adjustments relating to performance for non-admitted care will apply to 25% of total elective income. 
4.72	The overall adjustment will be capped at 2% of total contract income if this is less than 5% of total elective income.
4.73	18 Week performance will be measured and financial adjustments applied in relation to each contract with the provider.  Where a PCT holds their own contract with a provider, adjustments will be applied in relation to the provider’s performance for that individual PCT.  Where a PCT has used the host PCT’s contract, adjustments will be applied in relation to the provider’s overall performance for all the PCTs included in the contract.
4.74	18 Week performance in relation to pathways that include referrals from a secondary care clinical team in the Provider to a different tertiary care clinical team in another provider will not be subject to financial adjustments. 
4.75	The measurement of 18 Week performance and the performance targets appropriate for individual providers in relation to the 18 Week March 2008 milestone and December 2008 Referral-to-Treatment targets  shall be informed by Department of Health guidance.
4.76	Co-ordinating Commissioners will be able to reduce or waive financial adjustments in relation to 18 Week performance where the Co-ordinating Commissioner does not consider the financial adjustments appropriate in the context of the overall performance of their Local Health Community.

5.	PATIENT BOOKING AND PATIENT CHOICE  
5.1	In this Clause, the following definitions are used
“Choose and Book”	the national electronic system developed for the NHS to facilitate patient choice and booking of appointments with Providers 	
“Directly Bookable System”	where the Choose and Book system is integrated with the provider’s Patient Administration System as opposed to an “Indirectly Bookable System” where patients need to call the provider’s own booking centre to arrange their appointment 	
“Directory of Services”	the menu of services listed in the Choose and Book application	
“nhs.uk”	website with further information for patients about services delivered by a particular Provider	

5.2	Patient Choice
5.3	All first outpatient services advertised on the national menu must be directly bookable through Choose and Book.
5.4	Providers wishing to add their services to the national menu for extended choice are responsible for loading their services onto the Directory of Services (DoS) and then adding these to the national menu. Providers must use their agreed branding name and adhere to the service naming convention. They should also add Service Details (previously known as Service Specific Booking Guidance) so that referrers have enough information to make appropriate referrals.
5.5	Providers adding services to the national menu should make specified information available to prospective NHS patients through the NHS Gateway at www.nhs.uk and other specified media that provide general information to patients and the public about the facility and services offered. 
5.6	Booking
5.7	The overall objectives for booking patients appointments with providers is that the GP or other referring practitioner:
5.7.1	Offers the patient a clinically appropriate choice of provider; and 
5.7.2	Ensures that the patient is in a position to agree a mutually acceptable date and time of appointment with the service of their choice using the Choose and Book system as a secure method of referral and electronic booking.
5.8	In order to achieve the overall objective, both commissioners and providers must:
5.8.1	Comply with all extant DH policy on Choice and Booking
5.8.2	Ensure that there is a structure that can support the implementation and maintenance of the Choose and Book system (eg Registration Authority, training etc)
5.8.3	Ensure that all staff involved in the referral of patients or the booking of appointments have access to the Choose and Book system
5.8.4	Ensure that all appropriate staff involved in the process are appropriately trained in the use of the Choose and Book system
5.8.5	Ensure that “Sufficient appointment slots” are made available on the Choose and Book system.  “Sufficient appointment slots” means that patients:
5.8.5.1	always have access to the provider of their choice; and

5.8.5.2	can always choose between at least two separate appointment dates with reasonable notice and within a period consistent with national DH policy.  

5.8.6	Ensure that there are contingency plans in place to deal with the referral of patients on to other services should the Choose and Book system be temporarily unavailable for any reason (e.g. due to technical issues)
5.9	In order to achieve the overall objective, commissioners must:
5.9.1	Ensure that all GP practices have appropriate IT infrastructure that will support the implementation and use of the Choose and Book IT system
5.9.2	Ensure that all staff are appropriately trained in the use of the system and that ongoing training for new staff, system upgrades and new developments is available in a timely manner
5.9.3	Regularly review capacity available on the Choose and Book system to ensure “Sufficient appointment slots” are available on the system
5.9.4	Work with providers to ensure that the Directories of Services for all commissioned providers are published in a timely manner and that they are in a format that will facilitate referral to appropriate services
5.9.5	Ensure that there are robust arrangements in place with providers [in accordance with Clause and the Prior Approval process] to deal with any inappropriate referrals where a patient is referred by primary care to the wrong service in secondary care.  Commissioners need to ensure that the patient is redirected to the correct service in a timely manner, and after consultation about an agreeable date and time of appointment.
5.10	In order to achieve the overall objective, providers must:
5.10.1	Work with clinicians in both secondary and primary care to produce and publish a Directory of Services that, at all times, accurately and appropriately describes the services provided by the Trust and that enables accurate and appropriate referral to services by referring clinicians
5.10.2	Regularly review available capacity across all commissioned services to ensure that Sufficient slots are made available on the Choose and Book system using a Directly Bookable System unless an exemption has been agreed with the Department of Health
5.10.3	Ensure that the Trust provides the appropriate IT infrastructure necessary to support the implementation and use of the Choose and Book IT system, including implementing, when available, a National Programme for IT Choose and Book compliant Patient Administration System to provide a directly bookable system
5.10.4	Ensure that there are contingency plans in place for the receipt of referrals in the event that the Choose and Book IT system is temporarily unavailable for any reason (e.g. due to technical issues).

6.	NATIONAL AND LOCALLY AGREED QUALITY STANDARDS
6.1	The Provider and the Co-ordinating Commissioner shall (i) meet and maintain national quality standards and any other national quality requirements that may from time to time be specified, (ii) agree local quality improvements of health and wellbeing and reduction of health inequalities in line with local priorities and the expressed preferences of local communities.  The context for this was set out in National Standards, Local Action: Health and Social Care Standards and Planning Framework 2005/06-2007/08 (July 2004).  This document set a three year framework for all NHS organisations and contained two annexes – Standards for Better Health and National Targets.
6.2	National quality standards, targets and requirements 
6.3	At  present the main national quality requirements as set out in the Standards for Better Health (SfBH) document comprise core standards that all providers are expected to meet and developmental standards to be reached at a pace determined locally. Within the clinical effectiveness domain of SfBH, NICE technology appraisals are part of the core standards while NICE clinical guidelines and National Service Frameworks form part of the developmental standards
6.4	In the future, it is envisaged that a smaller set of core standards covering safety and quality will form the basis for the registration/licensing regime to overseen by the Regulator. Some additional National quality requirements may be set out from time to time in the Operating Framework.
6.5	The key national deliverables for the three year period ending in March 2008 are set out in Annex B to National Standards, Local Action.  
6.6	Local improvements shall be agreed for the following target:

National Target	Local value of national target	
MRSA bacteraemia	Providers to hit the LDP trajectory for 2007/2008. The reporting threshold is ≥ 12 cases 1	

1 This value shall be a single value for the Co-ordinating Commissioner commissioning from the provider

6.7	The Annex also sets out existing commitments arising from the 2003-06 planning round.  PCTs and their partner organisations are expected to achieve and deliver these commitments and thereafter maintain this level of performance.  The following national standards are former targets set out in National Standards, local Action and must be maintained as part of the Agreement:
•	4 hour maximum wait in A&E from arrival to admission, transfer or discharge (operating standard of 98% per month);
•	maximum wait of 3 months for revascularisation;
•	maximum waiting time of 1 month from diagnosis to treatment for all cancers (operating standard 98%)
•	Maximum waiting time of 2 months from urgent referral to treatment all cancers (operating standard of 95%)
•	2 week maximum wait for urgent suspected cancer referrals from GP to first outpatient appointment;
•	2 week maximum wait for rapid access chest pain clinic:
•	maximum wait of 3 months for GP referrals to first outpatient appointment and 6 months for inpatient admission to hospital
•	patients who have operations cancelled for non-clinical reasons will be offered a another binding date within 28 days of the original date or fund the patient’s treatment at the time and hospital of the patient’s choice.

6.8	Co-ordinating Commissioners and providers will agree, maintain and deliver local targets that reflect local priorities using appropriate currencies and thresholds.  All Agreements will include a local target setting out a locally appropriate significant reduction in cases of clostridium difficile:
Local Target	Local value 	
Clostridium Difficile 	Significant reduction in C. Diff. in 2007/2008 based on the 2005 threshold. The significant reduction to be set by the Coordinating Commissioner in discussion with Providers 	

1 This value shall be a single value for the Co-ordinating Commissioner commissioning from the provider

6.9	The monitoring and performance management of the national targets, national standards and local targets are subject to Clause 10 in the Agreement. 
6.10	Local Co-ordinating Commissioner/Provider Performance Indicators
6.11	The Co-ordinating Commissioner will (i) seek assurance from the Provider that they will performance manage each clinical service using clinical audit against key standards, and (ii) during 2007/2008 to implement or to work towards the development for implementation  appropriate outcome and output based KPI.  
6.12	The Parties will agree KPIs based on:
•	KPIs and thresholds to be agreed with the Co-ordinating Commissioner where the Co-ordinating Commissioner has local priorities;
•	KPI and threshold to be based on evidence, though the threshold may be agreed after a period of data collection to define the standard;
•	KPI chosen will be from sources recognised by the DH including nationally defined indicators, indicators from appropriate Framework documents, from guidelines produced by Royal Colleges and Specialist Associations.
•	KPIs are based and reported on patient level data. 
•	The chosen KPIs should be ones that avoid promoting perverse clinical behaviour. 

6.13	Where appropriate the indicators and their thresholds will be agreed between the parties in on a three (3) year rolling programme. The aim of the indicators are to promote the delivery of evidenced based safe patient care whilst promoting innovation in clinical and service practice.
6.14	During the period of the Agreement the Co-ordinating Commissioners will look for evidence that Performance Indicators and clinical audit have been used in the performance management of the clinical services delivered by the Providers.
6.15	Performance of Providers and Co-ordinating Commissioners will be reviewed against progress towards meeting the agreed indicators with threshold levels being set by the Co-ordinating Commissioners following discussion with the Providers. 
6.16	Providers and Co-ordinating Commissioners will discuss and agree the information flows required over and above those included within Clauses 7 of the Agreement in support of monitoring compliance with this Clause 6.  Such additional information requirements will be included within Annex 3 of the Agreement.

7.	INFORMATION FLOWS AND RECORDS AND REPORTING PROVISIONS

7.1	This Schedule documents the requirements for information flows between the Provider and the Co-ordinating Commissioner. There is a mutual and common acceptance of responsibility under the Agreement.
7.2	General 
7.3	The Provider shall comply with relevant published NHS information and data standards, including those set out in Data Set Change Notices (DSCNs). The Provider shall notify commissioners promptly where standards are not followed.
7.4	Both parties acknowledge that it is essential to provide timely and accurate monitoring information to fulfil their aims and statutory responsibilities.
7.5	The parties will review the requirements for locally agreed data flows on an annual basis to ensure continuing relevance. Changes to existing requirements, as well as any new requirements will be subject to agreement between the parties and shall be agreed as a Variation to the Agreement. Wherever possible, centrally submitted data will be used, to reduce duplication of effort.
7.6	National Reporting 
7.7	The Provider shall supply to the Co-ordinating Commissioner any information required for national reporting requirements. Appendix 1 outlines current requirements for information returns and data flows to Co-ordinating Commissioners to meet national reporting requirements. 
7.8	Contract Monitoring 
7.9	Full details of the agreed format of the contract monitoring Report as referred to in Clause 4, are given in Appendix 2. The Report will compare actual performance against the forecasts in the Activity Profile. In the Report, actual performance will be analysed on a year-to-date basis and on a month-by month basis. 
7.10	Management information requirements for the monthly review meetings are described in appendix 3b. It is recognised that CDS flows have shortcomings in terms of enabling a full understanding of contract performance. In order to overcome this, the Provider shall supply further supplementary monitoring information, as necessary, to enable effective monitoring of all contract lines which are not adequately supported by CDS flows. Full details are set out in Appendix 3b.  
7.11	The Provider shall report to the Co-ordinating Commissioner on non-Tariff services in appropriate bands [to be locally defined] based on locally agreed service prices. The Provider will use locally-agreed data capture methodologies for these services. 
7.12	Local Reporting 
7.13	The Provider agrees to provide locally defined data sets set out in appendix 3a (locally agreed Commissioner Data Sets) and appendix 3b (locally agreed Aggregate Data Sets). 
7.14	The Provider agrees to provide the monitoring information on clinical KPIs set out in appendix 3c. 
7.15	Ad hoc Information Requests
7.15.1	There may be occasions when the Co-ordinating Commissioner wishes to request additional information not included in appendix 3.  To make such ad hoc data requests, the Co-ordinating Commissioner will use a standard pro-forma, agreed between the parties, which will indicate the purpose and priority of the information requested.  The Co-ordinating Commissioner [Information Manager] will email any such requests to the Provider [Director of Information].
7.15.2	The Provider will respond to the Co-ordinating Commissioner, as early as possible, and within one week, indicating:
•	Whether the information will be provided or not.
•	If not, reasons for this decision.
•	If it is to be provided, the timescale.
•	An estimate of cost for the work involved (if material). 

7.16	Data quality 
7.17	Parties will agree annually the local data quality and quality improvement standards, as set out in appendix 4. 
7.18	Parties agree to conduct ongoing validation and reconciliation of CDS data, on a monthly basis, in order to try to achieve the closest possible match prior to production of monitoring information. The Co-ordinating Commissioner, in a timely fashion, will highlight any material variances within the reconciliation reports to the Provider for investigation and response and will resolve any disagreements in relation to such matters in accordance with Clause 10 of the Agreement. 

8.	SERVICE IMPROVEMENT/DEVELOPMENT, BUSINESS CONTINUITY, DUTY OF PARTNERSHIP
8.1	All Parties wish to encourage the improvement of Services, quality, clinical outcomes, patient satisfaction, information provision and the Services Environment and the Co-ordinating Commissioner/Commissioning Committee and the Provider may agree a Services development plan to deliver such improvement setting out the respective obligations of each Party having regard, in particular, to any joint obligations.  
8.2	The Provider shall create and maintain a Business Continuity Plan in respect of all aspects of the Services and shall, if any event causes such Business Continuity Plan to be activated, notify the Co-ordinating Commissioner within five (5) Operational Days of such activation.
8.3	The Provider is required to co-operate fully with the Co-ordinating Commissioner, the NHS Parties and any third party engaged by the Co-ordinating Commissioner in order to:
8.3.1	ensure a coordinated approach to promoting the quality of patient care across clinical pathways spanning more than one Provider; and
8.3.2	achieve a continuation of the Services that avoids any inconvenience or any risk to the health and safety of patients and/or of employees of the Co-ordinating Commissioner and members of the public;
which shall include, where appropriate, participating in clinical networks or other partnership arrangements in place within the local health economy and specialised commissioned activity for the locality of the Co-ordinating Commissioner(s) being that geographical area, the boundaries of which are set out in the Co-ordinating Commissioners’ Establishment Order.

9.	MONITORING AND PERFORMANCE MANAGEMENT
9.1	The Provider is responsible for monitoring its performance of this Agreement, and for providing the Commissioner with relevant particulars of any aspects of its performance which fail to meet the requirements of this Agreement.
9.2	The Co-ordinating Commissioner and the Provider may meet at least every 3 Months, and at other such intervals as they may agree, to formally discuss performance of the Agreement, and particularly the Activity Plan, financial performance and clinical care.
9.3	Contract Query
9.4	Where the Commissioner or any of its Associates have a query regarding the Provider’s performance under this Agreement, or the Provider regarding performance by any of them, they may issue a Contract Query in writing setting out the nature of the query.  The recipient is obliged to reply in writing to any Contract Query within 14]days of its issue. 
9.5	Performance Notice
9.6	Where the Commissioner or any of its Associates has reasonable evidence that performance of the Services fails to meet with requirements under this Agreement in relation to one or more of the areas set out below, may issue a Performance Notice to the Provider setting out the matter(s) giving rise to that Performance Notice and containing a reminder of its implications:
9.6.1	where there has been failure to meet the Quality Standards and Recommendations;
9.6.2	where the Provider fails to provide the volume of activity 
9.6.3	where there has been a negative audit finding;
9.6.4	where the number or nature of Patient complaints gives rise to Commissioner concern or there is a failure in the Provider's complaints handling process;
9.6.5	if there is intervention by the Independent Regulator directly leading to a risk affecting or, in the reasonable opinion of the Commissioner likely to affect the ability of the Provider to provide the Services;
9.6.6	where the Provider is in breach (whether or not material) under Clause 5;
9.6.7	where the Provider fails to reply to a Contract Query or a Service or Agreement Variation Notice ;
9.6.8	where the Provider fails to discharge any of its other obligations under this Agreement.
9.7	Where the Provider has reasonable evidence that performance of the Commissioner or any of its Associates fails to meet with requirements under this Agreement in relation to one or more of the areas set out below, may issue a Performance Notice to the Co-ordinating Commissioner/ Commissioning Committee setting out the matter(s) giving rise to that Performance Notice and containing a reminder of its implications:
9.7.1	where the Commissioner or any of its Associates is late in any payments to be made under this Agreement; or
9.7.2	Where there is an overpayment or underpayment  by the Commissioner or any of its Associates of any sums due under this Agreement; or
9.7.3	where the Commissioner or any of its Associates fails to adhere to any referral protocols agreed between the Co-ordinating Commissioner/ Commissioning Committee and the Provider;
9.7.4	where the Co-ordinating Commissioner/ Commissioning Committee fails to reply to a Contract Query     
9.7.5	where the Commissioner or any of its Associates fails to discharge any of its other obligations under this Agreement.
9.8	Performance Notices that are agreed, or determined in dispute resolution to have been issued in circumstances where such issuing was not justified shall be deemed to have been cancelled.
9.9	Warning Notice
9.10	Without prejudice to the rights of the Commissioner, any of its Associates or the Provider under this Agreement, if at any time the Provider or the Commissioner or any of its Associates has;
9.10.1	committed any material breach of its obligations under this Agreement and where it is capable of remedy has not remedied such breach within 10 days of receipt of written notice to remedy; or
9.10.2	accrued more than 2 Performance Notices in any 3 Months, 
9.10.3	then the Provider may give a Warning Notice to the Commissioner, or the Commissioner may give a Warning Notice to the Provider, setting out the matter(s) giving rise to that notice and containing a reminder of its implications and details of the matter(s) for which Performance Notices were issued.  Any such notice shall state on its face that it is a "Warning Notice"
9.11	Within 10 days of the issue by either party of a Warning Notice the Parties shall meet to discuss the subject matter of any Warning Notice and agree a Remedial Action Plan.
9.12	Remedial Action Plan
9.13	The Remedial Action Plan will specify:
9.13.1	targets and timescales within which such targets shall be achieved; and 
9.13.2	the sanctions applicable in the event of any breach of the Remedial Action Plan.
9.14	If the parties are unable to agree the Remedial Action Plan, or within 5 Business Days of any breach by the Provider or the Commissioner of the Remedial Action Plan, then either party may (without prejudice to any other express rights under this Agreement including the right of either party to refer the matter to the Dispute Resolution Process) issue an Exception Report to the SHA who may take such steps as they think fit having regard to their respective functions and those of the Commissioner and the Provider.  Such steps shall include publishing the Exception Report as they think fit although any such publication shall be subject to the public interest disclosure requirement. 
10.	DISPUTE RESOLUTION PROCEDURE 
10.1	A dispute resolution procedure may be invoked by either party to the Contract if there is a failure to agree. This may occur either before or after the Contract is agreed. The disputes procedure has two stages: mediation, followed by adjudication if the dispute remains unsettled.
10.2	Disputes involving NHS Trusts will be mediated by the Strategic Health Authority. 
10.3	At the mediation stage the decision about the solution to the dispute remains with the two parties to the Contract (PCT and provider). The two parties will be assisted to come to a resolution through the good offices of the relevant SHA. In order to invoke the disputes procedure, the two parties concerned must submit to the SHA a document signed by both parties that describes the precise points over which they disagree. If the SHA is satisfied that the nature of the dispute has been adequately documented, they will invite the parties to describe their own solution to the dispute. The parties will have five working days to provide this documentation, and a further five days to comment on the other party’s solution. At the end of this time the mediators will invite the parties to agree. 
10.4	If a dispute cannot be resolved at the mediation stage, the SHA will adjudicate.
10.5	 The costs of the adjudication will be borne by the unsuccessful party to the dispute. 

11.	NHS BRANDING AND PROMOTION
11.1	The Provider and the Co-ordinating Commissioner shall ensure that:
11.1.1	their facilities [signage, uniforms, badges, vehicles, stationery], services [marketing and patient information] and any other type of communication [including recruitment advertising, websites] are clearly branded by using the NHS logo in accordance with the NHS brand policy at www.nhsidentity.nhs.uk 
11.1.2	they comply with the NHS values and communication principles set out in appendix III of the guidance.
11.1.3	they will operate within a self-regulatory system, underpinned by the  Code of Practice for Promotion of NHS Services as published and amended from time to time. The self-regulatory system will be administered by a secretariat and expert panel. In extreme circumstances, referral by the secretariat or expert panel to the Co-ordinating Commissioner could ultimately lead to termination of the contract if the secretariat or expert panel determines that lesser sanctions have not been sufficient.
12.	CONFLICTS OF INTEREST
12.1	If either party becomes aware of any conflict of interest which has or is likely to have an adverse effect on the other party’s decision (acting reasonably) to determine whether or not to contract with or continue to contract with the other party substantially on the terms of this Agreement, the party aware of the conflict shall immediately declare such an interest to the other and the other party shall take such action under this Agreement as it deems necessary.

13.	EFFICIENCY STANDARDS
13.1	The provider, if initiating treatment with statins, is required to ensure that 80% of such patients are prescribed a generic statin.

13.2	The provider is permitted to carry out the following maximum number of outpatient follow-up appointments for any individual patient, by specialty:
	
Specialism	Maximum number of outpatient follow-up attendances for any patient	
100: Gen. Surgery	2	
101: Urology	2	
110: T & O	2	
120: E.N.T	1	
130: Ophthalmology	2	
140: Oral Surgery	2	
150: Neurosurgery	2	
160: Plastic Surgery	2	
502: Gynaecology	2	
170: Cardiothoracic Surg.	1	
300: General Medicine	3	
301: Gastroenterology	2	
320: Cardiology	2	
400: Neurology	4	
410: Rheumatology	4	
430: Elderly Medicine	1	
420: Paediatrics	1	
All Other G&A	3	

13.3	In the event that further follow-up attendances are required or anticipated, the provider is required to furnish a care plan for the patient to the commissioner for approval, indicating clearly the proposed follow-up regime and reasons for such a regime. Failure to comply with this requirement may lead to repudiation of charges on the grounds of activity deemed to be carried out outwith the terms of this service level agreement.

13.4	The following exceptions apply to the maximum numbers in 13.2 above
Specialty 320 (Cardiology): the upper limit on outpatient follow-up attendances will not apply to patients suffering from pulmonary hypertension, congenital heart disease, or genetic disorders

Endocrine medicine: conditions involving growth hormone deficiency are subject to a maximum of 4 follow-up appointments before application of  clause 13.3

Specialty 301 (Gastroenterology): there is no upper limit on follow-up attendances for severe Crohn’s disease

13.5	The commissioner and provider recognise a mutual obligation to ensure timely and safe discharge for patients. For all non-elective patients, the provider and commissioner will comply with the following process:
•	All non-elective admitted patients should be furnished with a care plan and ACTUAL discharge date within 36 hours of admission (note that use of Estimated discharge date should be eliminated in order to ensure greater compliance with discharge deadline). The patient and family should be made aware of the care plan and discharge date
•	The care plan (including discharge date) should be sent to the commissioner and GP (who, within a PBC arrangement, might be the same). The care plan should include not only the medical pathway, but also assessment requirements for discharge if necessary 
•	The care plan should be owned by the patient, admitting consultant, ward manager and commissioner
•	Discharge date should be seen as an integral component of the care plan by the admitting consultant and ward management
•	Blockages in the medical pathway which might delay discharge should be actioned immediately by the ward management with a view to avoiding delay
•	If all components of the care plan have been fulfilled, the patient should be discharged without reference to further medical opinion, by ward management. 
•	If discharge date is breached, an exception report should be sent to the commissioner detailing reasons for breach.
•	If the care plan requires the input of community-based services in order to achieve the discharge date, the commissioner should act upon ensuring availability of such services well in advance of discharge
•	The commissioner will not be liable for any additional charge resulting from lack of adherence to the care plan unless there is a jointly agreed change to the plan or responsibility for failure is not attributable to the provider.

Appendix 1 - National Reporting Requirements

Appendix 2 – Format of contract monitoring Report

Appendix 3 - Local Agreement

Appendix 3a - Local Agreement – Commissioner Data Sets

Appendix 3b - Local Agreement – Aggregate Data Sets

Appendix 3c - Clinical KPIs 

Appendix 4 - Data quality

Appendix 1 - National Reporting Requirements

This Appendix outlines the requirements for information returns and data flows to be provided to the Commissioner to meet national reporting requirements.      

Report Type	Frequency	Deadline	Provided to	
UNIFY reporting 	Weekly	Tuesday (following reporting period)	DH & PCTs	
QM08R part 1	Quarterly	7th working day of month following reporting period	DH & PCTs	
QM08R part 2	Quarterly	7th working day of month following reporting period	DH & PCTs	
KH07aR	Quarterly	7th working day of month following reporting period	DH & PCTs	
QF01	Quarterly	7th working day of month following reporting period	DH & PCTs	
MMI activity and Waiting List data1 (for Inpatients and Outpatients)	Monthly	7th working day of the month following reporting period	DH & PCTs	
Diagnostics Waiting Times and Activity return 1	Monthly	10th working day of month following reporting period	DH & PCTs	
KH06R	Quarterly	7th working day of month following reporting period	DH & PCTs	
Local Delivery Plan return (LDPR) 	Quarterly	[7] working days before national reporting deadline.	DH & PCTs	
18 weeks Referral to Treatment (RTT) times monthly monitoring	Monthly 	[7th working day of month following reporting period	DH & PCTs	
Outturn/Outturn Forward	Annual	[Nth] working day of month following reporting period	PCTs	
GUMAMM	Monthly	[Nth] working day of month following reporting period	PCTs and DH	
Outpatient CDS	Monthly	national timetable	SUS	
Admitted patient care CDS	Monthly	national timetable	SUS	
A&E CDS	Monthly	national timetable	SUS	

Notes:

1. There are specific stages of treatment milestones for inpatient, diagnostic and outpatient waiting times through 2006 to 2008 in the run up to the 18 week target. DH will require data from the NHS on outpatient, diagnostic and inpatient waiting times to monitor progress towards and assess achievement of these milestones. Therefore existing outpatient, diagnostic and inpatient waiting times central returns will continue until 2008. After 2008, central returns to support the monitoring and performance management of existing waiting times standards will be derived from Secondary Uses Service (SUS). The requirement for the NHS to send returns directly to the DH will be removed once confidence in the data flow through the SUS is established.

Appendix 2 – Format of Contract Monitoring Reports

[Insert details of locally agreed format]
Appendix 3 - Local Agreement

Appendix 3a - Local Agreement – Commissioner Data Sets

This Appendix outlines the requirements for patient level data sets to be provided to the Commissioner under local agreement. 

Report Type	Format and data Fields required	Frequency	Due date	Provided to	

Appendix 3b - Local Agreement – Aggregate Data Sets

This Appendix outlines the requirements for aggregate data sets to be provided to the Commissioner under local agreement. 

[DN If locally-agreed timetable for monthly CDS submissions are early enough to be used to compile the monthly Contract Monitoring Reports, then most of the lines of the following table will not be required and may be deleted.]

Report Type	Data Fields required	Frequency	Deadline	Provided to	
Contract Monitoring: 
emergency spells1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
other spells1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
A&E attendances1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
elective spells1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: excess bed days1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
First outpatient attendances, consultant-led1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
First outpatient attendances, non-consultant-led1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Subsequent outpatient attendances, consultant-led1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Subsequent outpatient attendances, non-consultant-led1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
GP referrals to outpatients1
	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Consultant-to-consultant referrals1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Other referrals to outpatients (excl c2c)1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
First outpatient attendances following GP referral, consultant-led1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
GP referral attrition rate1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Conversion rate1
	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Ratios subsequent to first outpatient attendances1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Procedures in outpatients1
	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Diagnostic tests and procedures1	Year-to-date totals;
Totals for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Referral-to-treatment times – admitted1
	Totals for most recent month.
Totals 18w or less for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Referral-to-treatment times – non-admitted1
	Totals for most recent month.
Totals 18w or less for most recent month..	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Inpatient waiting list1
	Totals at end most recent month.
Totals 11w+ at end most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Outpatient waiting list, following GP referral1
	Totals at end most recent month.
Totals 5w+ at end most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Diagnostics waiting list, following GP referral1
	Totals at end most recent month.
Totals 6w+ at end most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
Emergency bed days1
	Year-to-date total;
Total for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
Contract Monitoring: 
[locally-specified]1
	Year-to-date total;
Total for most recent month.	Monthly	[Nth] working day of month following reporting period	[name]	
[locally-specified]					
Notes:
1. For the Contract monitoring report, a breakdown is required for each of the specialties, specialty-groups, and HRGs specified in the corresponding page of the Contract Activity Profile. [Or can specify a more detailed specialty breakdown here.]

Appendix 3c - Clinical KPIs 

This Appendix sets out the proposed core quality indicators and information flows to support monitoring. These requirements will be reviewed on a quarterly basis.

Section1: Access

Quality Indicator	Frequency	
1	[Indicator] 	
Rationale		
Source			

Section 2: Clinical care Indicators

Quality Indicator	Frequency	
1	[Indicator] 	
Rationale		
Source			

Section 3: Processes

Quality Indicator	Frequency	
1	[Indicator] 	
Rationale		
Source			

Appendix 4 - Data quality

[Insert details of locally agreed data quality and quality improvement standards]

ANNEX  1 – ACTIVITY PLAN

Annex 1 refers to the activity plan. Parties can use the national template provided in Excel spreadsheet forma, or locally agreed formats.

ANNEX 2 – PRIOR APPROVAL AND UTILISATION MANAGEMENT 

1	The following Prior Aprroval requirements,pursuant to Clause 4.26 to 4.30 apply to this Service Level Agreement. Providers should seek approval from the PCT responsible for its contract/SLA (hereafter referred to as ‘the PCT’).  This may not be the PCT with which the patient is registered.  The PCT responsible for the contract will then make contact with the patient’s PCT where further authorisation is required. Prior approval is required to be sought by the Provider in the following circumstances:

1.1	Procedures of Limited Clinical Effectiveness

The productivity metrics issued by the NHS Institute for Innovation and Improvement include the following treatments which offer little or no benefit:
•	Tonsillectomy
•	Dilatation and curettage
•	Hysterectomy
•	Lower back surgery
•	Myringotomy

In addition the following treatments are of low priority:

•	Low-grade varicose veins surgery
•	Cosmetic surgery
•	Gender reassignment surgery

Providers will need to seek prior approval from the commissioner before such treatments are carried out. Failure to comply with this requirement may lead to repudiation of charges on the grounds of activity deemed to be carried out outwith the terms of this service level agreement.

1.2	High-cost treatment

Any treatment which exceeds an aggregate cost (including HRG cost, drugs and devices) per spell of £10,000 must be notified to the Commissioner for prior approval prior to confirmation of a treatment date to the patient. Failure to comply with this requirement may lead to repudiation of charges on the grounds of activity deemed to be carried out outwith the terms of this service level agreement.

1.3.	Cataract surgery

Cataract surgery may be carried out only in compliance with the Commissioner’s thresholds for visual acuity. These are attached as Annex 2.1

1.4	Outpatient follow-up attendances beyond upper limits specified in Clauses 13.2 to 13.4. Details of the prior approval requirements are specified in the aforementioned clauses,

1.5	High cost devices

The attached Annex 2.2 lists each device and assigns a traffic light in accordance with the following principles:

	Green	The device is either:
•	NICE-approved for the indication listed.
•	Covered by a local policy governing its use.
•	Covered by a national policy governing its use (e.g. a Royal College guideline).
•	Recognised as standard clinical practice.

Prior approval is not required, unless the provider intends to use the device outside the criteria in the guideline/policy.

An audit of compliance with policy/guidelines may be conducted by the commissioner from time to time.
	
	Amber	The device is approved for use only in certain circumstances. 

Clinical details for the individual patient must therefore be provided and approval for funding sought on a case-by-case basis.  

Approval will not be unreasonably withheld where use is clinically indicated.
	
	Red	The device will not normally be funded.  

This is usually because NICE has found that the evidence does not support use.  If the provider believes there are exceptional circumstances, an appeal may be made to the relevant PCT’s special cases panel.	

The Commissioners aim to minimise the need to seek prior approval for the use of devices.  Where no national guideline exists, they will seek to develop local policy, enabling the device in question to be re-designated as ‘green’.  Where possible, local policy will mirror existing policy in use at the main provider. Providers’ co-operation in supplying copies of provider policy and informing the PCT of any additional national guidance available would be appreciated.

Updates to the Annex will be circulated as local policy is developed or as new NICE or other national guidance becomes available.  

Approval should be sought immediately the anticipated need for the device becomes known, e.g. when the patient is added to the waiting list for an intended procedure likely to involve use of an excluded device.  The request for approval should include an estimated date when expenditure will be incurred.  The provider should not wait until a TCI date has been identified before seeking approval.  Late requests may result in routine procedures being delayed, or even in approval being withheld because the PCT has not been able to plan for the expenditure.

1.6	High Cost Drugs

The provider is expected to comply with the East of England policy on the usage of high cost drugs. The principles with respect to specific drugs is set out below, and the prior approval policies relating to specific named drugs is set out in Annex 2.3

Policy

•	Drugs that are specifically excluded from PbR will normally only be funded within NICE guidance eligibility criteria, or where there is an agreed funded policy in place.  Where NICE guidance is issued in year this will be funded through the Trusts unless there is specific exclusion from PbR.

•	In exceptional clinical circumstances appeals will be considered.
 
•	Cost-effectiveness of treatments will be considered when selecting suitable treatments from within a range of treatments.

•	Treatment outside licensed indications will not normally be supported.

•	Policy and criteria will be reviewed when NICE guidance (Health Technology Assessment or cancer guidance is published or reviewed).

•	Costs will be on the basis of drug cost only. The cost will be the lowest available to the provider and if there are differences the choice of provider may be reviewed
. 
•	Reviews of treatment by specialists to adjust or discontinue treatments annually are required.

•	It may be necessary to prioritise treatments, or plan in numbers of new cases that can be treated.

•	Prior approval for funding is necessary in the majority of cases except where the Trust can demonstrate systems of monitoring and accountability to the satisfaction of the commissioning PCT. If this is not agreed, the Trust will be treating at its own financial risk. (see Annex 2.3 for details of prior approval requirements for specific drugs)

•	The PbR Technical Guidance 2005/06 refers to ‘pass-through’ funding for drugs that have recently been launched and for which NICE guidance is not expected within a short time scale, or new drugs that will not be subject to NICE guidance.  Such pass-through funding arrangements will not be considered.

•	Acute Trusts should audit use of all those products within the list to ensure that they are being used within NICE Guidance or local protocol.  It is expected that audit would take place on a regular basis through an audit cycle linked to the Clinical Audit Plan.

2.	The commissioner reserves the right to investigate, by independent audit or other recognised utilisation management or predictive tool, the following areas of activity:

•	Increases in average aggregate casemix value above 5% in real terms
•	Multiple new or follow-up outpatient activity occurring, for the same patient, within a very short space of time
•	Waiting list attribution between urgent and routine for elective activity

Annex 2.2
COMMISSIONER POLICY ON DEVICES EXCLUDED FROM PAYMENT BY RESULTS (as at 1.4.07)

(a)	Device	Condition	Approved for use in Essex?	NICE/other guidelines available?	Prior approval required?	Criteria	Colour	
Aortic stents		Yes	NICE IPG127 (Jun 05)
Local guidelines to be developed	Yes, pending development of local policy (N.B. designated tertiary centres only)	Criteria under development; prior approval required in meantime	Amber	
Aneurysm coils	Intracranial aneurysm	Yes	Unruptured NICE IPG105 (Jan 05)
Ruptured NICE IPG106 (Jan 05) 	No	To be used in line with NICE guidance	Green	
Bespoke orthopaedic prostheses	Various	Yes	None	Yes	Funding requests to be submitted to specialist commissioning on case by case basis	Amber	
Bone anchored hearing aids	Hearing loss	Yes	Deaf Children’s Society quality guidelines	Yes	Criteria under development; prior approval required in meantime	Amber	
Carotid stents		Yes	NICE consultation document issued Aug 04	Yes	Funding requests to be submitted to specialist commissioning/relevant PCO on case by case basis	Amber	

(b)	Device	Condition	Approved for use in Essex?	NICE/other guidelines available?	Prior approval required?	Criteria	Colour	
Iliac stents		Yes	None	Yes	Funding requests to be submitted to specialist commissioning/relevant PCO on case by case basis	Amber	
Renal stents		Yes	None	Yes	Funding requests to be submitted to specialist commissioning/relevant PCO on case by case basis	Amber	
CPAP/BiPAP		Yes	British Thoracic Society
Local guidelines to be developed	Yes, pending development of local policy	Criteria under development; prior approval required in meantime, where possible.  (If prior approval impossible on clinical grounds, notification to be made as soon as practicable thereafter.)	Amber	
Deep brain stimulators	Parkinson’s and other movement disorders	Yes	PD - NICE IPG019 (Nov 03)
Other disorders – NICE consultation paper	No	To be used in line with NICE guidance	Green	
Vagus nerve stimulators	Epilepsy	Yes	NICE IPG050 (Mar 04)/ CG20 (Oct 04) 	No	To be used in line with NICE guidance	Green	

(c)	
Device	Condition	Approved for use in Essex?	NICE/other guidelines available?	Prior approval required?	Criteria	Colour	
Sacral nerve stimulators	Faecal incontinence	Yes	NICE IPG099 (Nov 04)	No	To be used in line with NICE guidance	Green	
Spinal cord stimulators	Chronic pain	Yes	British Pain Society and the Society of British Neurological Surgeons	Yes	Funding requests to be submitted to relevant PCO on case by case basis.  Will be approved only when condition amenable to SCS, as set out in BPS/SBNS guidelines.	Amber	
Gliadel wafers	Glioma	No (exceptional circumstances to be considered by special cases panel)	Ref???? (Apr 06)	Yes		Red	
Implantable defibrillators (ICDs)	Cardiac arrhythmia	Yes	NICE TA95 (Jan 06)	No	To be used in line with NICE guidance	Green	
Cardiac resynchonisation therapy (CRT)/ICD with CRT capability	Cardiac arrhythmia	Yes	NICE CG5 (Oct 03)

TA due Jul 07	No	To be used in line with NICE guidance	Green	
Ilizarov frames	Ununited fracture
Limb lengthening	Yes	None	Yes	Funding requests to be submitted to specialist commissioning on case by case basis	Amber	

(d)	Device	Condition	Approved for use in Essex?	NICE/other guidelines available?	Prior approval required?	Criteria	Colour	
Insulin pumps	Type 1 diabetes	Yes	NICE TA057 (Feb 03)	Yes	Funding requests to be submitted to relevant PCO on case by case basis.  	Amber	
	Type 2 diabetes	No		N/A		Red	
Intrathecal pumps	Severe spasticity
MS	Yes
Yes	
NICE CG8 (Nov 03)	No
No	To be used in line with NICE guidance (MS)	Green	
	Other indications (pain, etc)	No (exceptional circumstances to be considered by special cases panel)	SIGN guideline 44	Yes		Red	
Implantable loop recorders	Syncope	No (exceptional circumstances to be considered by special cases panel)	None	Yes		Red	
3 dimensional navigation system mapping catheters	Atrial fibrillation	Yes	None	Yes	Criteria under development; prior approval required in meantime	Amber	
Occluder septal devices	Septal defect	Yes	Atrial NICE IPG096
Perimembraneous NICE consultation paper	No	To be used in line with NICE guidance	Green	

Annex 2.3: Commissioner policy on excluded drugs
Group	2007-8 exclusions (categorised by BNF where appropriate)	Drugs	Condition	Approved for Use in EoE	NICE/Local Guidelines Available	Prior approval required	Criteria	
Cytokinine Inhibitors	1.5 Cytokinine Inhibitors	Infliximab	Crohn's Disease	Yes	NICE	No	Monthly invoice with patient identifer with criteria; new starters, patient's GP and PCT.	
	10.1.3 Cytokinine Inhibitors	Adalimumab	Rheumatoid arthritis/JIA	Yes	Local	No	Criteria to be further developed; low dose OK but higher dose not	
	 	Anakinra	Rheumatoid arthritis/JIA	No	 	N/A	Changes between drugs will not be funded without prior approval and are unlikely to be funded if the change occurs after 3 months of treatment.	
	 	Etanercept	Chronic plaque psoriasis	No	 	N/A	 	
	 	Etanercept	Rheumatoid arthritis/JIA	Yes	NICE	No	 	
	 	Etanercept	Ankylosing Spondylitis	No	 	N/A	Will consider developing local guidelines in advance of NICE guidance	
	 	Infliximab	Rheumatoid arthritis/JIA	Yes	NICE	No	Administration costs to be sorted out.	
Vasodilator antihypertensive drugs/Primary Pulmonary Hypertension	2.5.1  Bosentan	Bosentan	Primary Pulmonary Hypertension	Yes but only by specialised Tertiary Centres	London New Drugs Group review	Yes	 	
	2.5.1  Iloprost	Iloprost	Primary Pulmonary Hypertension			Yes	Not to be started in local hospitals	
	2.5.1  Epoprostenol	Epoprostenol	Primary Pulmonary Hypertension			Yes	Only funding single drug.	
	7.4.5  Phosphodiesterase type-5 inhibitors-Sildenafil	Sildenafil	Primary Pulmonary Hypertension			Yes	Licensed product now available.	
Torsion Dystonia and other involuntary movements	4.9.3  Riluzole	Riluzole	Amyotrophic Lateral Sclerosis/Motor Neurone Disease	Yes	NICE	No	Secondary care initiates but not for restless legs	
	4.9.3  Botulinum A 	Botulinum A	Involuntary movements as licensed but excluding use in hyperhidrosis	Yes	 	Yes	Seek prior approval; trusts to come back with indications and will develop local guidelines; prior approval required before treatment commences	
	4.9.3  Botulinum B 	Botulinum B		Yes	 	Yes		
Antifungals	5.2  Drugs used in fungal infections-Amphotericin-lipid formulations	Albecet	Fungal infections following advice from microbiology	Yes	Local	No	Microbiology approval before treatment commences	
	 	AmBisome		Yes	Local	No		
	 	Amphocil		Yes	Local	No		
	5.2  Drugs used in fungal infections-Caspofungin	Caspofungin		Yes	Local	No		
	5.2  Drugs used in fungal infections-Voriconazole	Voriconazole		Yes	Local	No		
AIDS/HIV antiretrovirals	5.3.1  Antiretrovirals	Abacavir	AIDS/HIV	 	 	No	Continue to manage through separate HIV/AIDS budget-Richard Gill for Mid-Essex; insert names for other health economies	
	 	Didanosine		 	 	No		
	 	Emtricitabine		 	 	No		
	 	Lamivudine		 	 	No		
	 	Stavudine		 	 	No		
	 	Tenofovir Disoproxil		 	 	No		
	 	Zalcitabine		 	 	No		
	 	Zidovudine		 	 	No		
	 	Amprenavir		 	 	No		
	 	Atazanavir		 	 	No		
	 	Fosamprenavir		 	 	No		
	 	Indinavir		 	 	No		
	 	Lopinavir with Ritonavir		 	 	No		
	 	Nelfinavir		 	 	No		
	 	Ritonavir		 	 	No		
	 	Saquinavir		 	 	No		
	 	Efavirenz		 	 	No		
	 	Nevirapine		 	 	No		
	 	Enfuvirtide		 	 	No		
Viral Hepatitis (B&C) and Respiratory Syncytial Virus	5.3.3  Hepatitis C drugs and 8.2.4 Interferon Alfa	Ribavarin	Hepatitis C	Yes	NICE	No	NICE criteria	
	 	Peginterferon alfa	Hepatitis C	 		No	 	
	 	Interferon Alfa		 		No	 	
	5.3.5-Respiratory syncytial virus	Palivizumab	RSV	No	National Guidance	N/A	Policy to be developed	
	 	Ribavarin		No	 	N/A	 	
Growth Hormone and Growth Hormone Receptor Antagonist	6.5.1-Anterior Pituitary Hormone-Growth Hormone Receptor Antagonist	Pegvisomant	Acromegaly	No	No	N/A	Not continuing to fund following clinical trials.	
	6.5.1-Anterior Pituitary Hormone-Growth Hormone	Somatotropin	GH deficiency as per NICE guidance	Yes	NICE	Yes for adults	NICE guidance only:  Children who are small for dates…new indication will not be funded.;  Child is defined as 11 years and under	
Drugs affecting bone metabolism	6.6.teriparatide	Teriparatide	Postmenopausal osteoporosis	Yes	NICE	No	 	
Immunomodulating Drugs	8.2.4-Interferon beta	Interferon Beta	Relapsing Remitting Multiple Sclerosis	Yes	DoH ABN guidelines	Yes	End point to be decided.CR/MT  Change over issues	
	8.2.5	Glatiramer	 	 	 	Yes	 	
	8.2.4-Interferon Alfa	Interferon Alfa	Hepatitis C	Yes	NICE	No	Not approved for any other indication.	
	 	Peginterferon alfa		Yes	NICE	No	 	
Somatostatin analogues	8.3.4.3	Octreotide	Acromegaly; Carcinoid syndrome	Yes	To be developed	No	Continue practise at present but develop criteria for use in carcinoid syndrome	
	 	Lanreotide	 	Yes	To be developed	No	 	
	 	Octreotide/Lanreotide	Acromegaly	Yes	To be developed	No	 	
Drugs used in Neutropenia	9.1.6	Filgrastim	Neutropenia	Yes	Yes	No	BSH guidance and ASCO guidelines.	
	 	Lenograstim		Yes	Yes	No	RN to share his guidelines	
	 	Pegfilgrastim		Yes	Yes	No	 	
Drugs Used in Metabolic Disorders	9.8.1	Carnitine	Inborn errors of metabolism or secondary deficiency in haemodialysis patients	Not to be initiated in secondary care	 	Yes	Not to be initiated within secondary care; NSCAG	
	Fabry's Disease	Agalsidase beta	Fabry's disease		 	Yes		
	Gaucher's Disease	Imiglucerase	Gaucher's Disease		 	Yes		
	 	Miglustat			 	Yes		
	Mucopolysaccharidosis 1	Laronidase	Mucopolysaccharide storage disorder		 	Yes		
	Nephropathic cystinosis	Mercaptamine (Cysteamine)	Nephropathic cystinosis		 	Yes		
	Urea cycle disorders	Sodium Phenylbutyrate	Urea cycle disorders		 	Yes		
	 	Betaine	 		 	Yes		
Hyperuricaemia associated with cytotoxic drugs	10.1.4	Allopurinol	Hyperuricaemia associated with cytotoxic drugs	 	 	N/A	Local agreement to include Allopurinol within PbR therefore no cross charging to PCTs	
		Rasburicase		No	 	N/A	 	
Drugs affecting Immune Response	13.5.3-Efalizumab	Efalizumab	Chronic plaque psoriasis	NO	 	N/A	Awaiting NICE	
Intravenous/subcutaneous human normal immunoglobulin	14.5-Normal Immunoglobulins-intravenous	Flebogamma; Sandoglobulin; Octagam, Vigam	Need to get list of indications	?	 	Yes	Priority area for developing local guidelines for use	
	14.5-Normal Immunoglobulins-subcutaneous	Subcuvia, Subgam; Vivaglobulin	and develop guidelines	?	 	Yes		
Antifibrinolytic drugs/haemostatics blood products	Haemophilia Blood Products	Antithrombin 111 Concentrate	Haemophilia	YES	YES	No	Obtain local guidelines, amalgamate and formalise across EoE	
		Drotrecogin alfa (Activated)(Recombinant activated protein C)	Severe sepsis in line with NICE guidance	YES	NICE	No	 	
		Factor V11a (recombinant)	Haemophilia	YES	YES	No	Obtain local guidelines, amalgamate and formalise across EoE	
		Factor V111 fraction, dried	Haemophilia	YES	YES	No		
		Factor V111 Inhibitor bypassing fraction	Haemophilia	YES	YES	No		
		Factor 1X fraction, dried	Haemophilia	YES	YES	No		
		Factor X111 fraction dried	Haemophilia	YES	YES	No		
		Fresh Frozen Plasma	When used to treat rare haemostatic conditions	YES	YES	No		
		Protein C Concentrate	Congenital protein C deficiency	YES	YES	No		

Key:	 	 	 	 	 	 	 	
 	 	Not approved for use; if Acute Trusts choose to treat this is at their financial risk.	 	 	 	 	 	
 	 	Approved for use in certain circumstances/prior approval is required for use/evidence will be required with invoices that patients meet criteria agreed.	 	 	 	 	 	
 	 	Approved for use in certain circumstances/prior approval is not required for use but evidence must be provided by Trusts(agreed data sets) before invoices will be paid; funding will not be authorised for patients who do not meet agreed criteria.