NWL CLINICAL COMMISSIONING GROUPS PROVIDER SERVICE SPECIFICATION 2015/16

Transcription

1 NWL CLINICAL COMMISSIONING GROUPS PLANNED PROCEDURES WITH A THRESHOLD AND INDIVIDUAL FUNDING REQUESTS PROVIDER SERVICE SPECIFICATION 2015/16 Service framework and guidance for providers in North West London for the application and service provision of Planned Procedures with a Threshold and Individual Funding Requests

2 Amendment history: Version Date Amendment history /02/2014 Chakshu Sharma updated to reflect changes to provider framework for 2014/ /02/2014 June Farquharson - final edit /12/2014 Chakshu Sharma updated to reflect changes to provider framework for 2015/ /2015 Chakshu Sharma updated Challenge Timetable /2015 June Farquharson - final edit Forecast changes: Anticipated change None When Reviewers: Name Signature Title / responsibility Date Version Chakshu Sharma June Farquharson IFR Business Development Manager Associate Director, IFR Service V0.4 V0.5 Distribution: All members of the Account Teams Provider Trusts Document status: This is a controlled document.

3 Related documents: These documents will provide additional information. Ref no Document reference number Title Version 1 NWL CCG Planned Procedure with a Threshold Policy 2 NWL CCG Ethical Decision Making Framework 3 IFR Operations Policy

4 Table of contents Section 1 Planned Procedures with a Threshold (PPwT) Planned Procedure with a Threshold introduction to policy PPwT provider roles and responsibility PPwT Authorisation and Challenge process PPWT validation process PPwT provider management report PPwT audit process PPwT key summary notes for providers Section 2 Individual Funding Requests Individual Funding Requests (IFR s) overview IFR Provider Role and Responsibility IFR key summary notes for providers Policy /Service Development Group Section 3 - Appendices Appendix 1 - Index of Planned Procedures with a Threshold (PPwT) and procedures requiring Individual Funding Requests (IFR) Appendix 2 IFR Operations Policy Appendix 3 IFR From Appendix 4 Urgent IFR Form Appendix 5: Update from Policy Development Group

5 Foreword The NHS North West London Individual Funding Request (IFR) and Planned Procedure with a Threshold Policy (PPwT) were established in April The policies are now part of the commissioning framework for North West London Collaboration of Clinical Commissioning Groups. The aim of Provider Service Specification is to provide guidance for providers to fulfil their contractual obligations in relation to continued operational implementation of the PPwT and IFR policies. The Provider Service Specification Framework (PSF) should be used as a handbook of reference for providers and will be refreshed and updated periodically as appropriate throughout the year. The PSF has been updated to reflect changes to the PPwT policy for 2015/2016 and refinements of any operational processes following discussion and agreement with providers, particularly around the audit and challenge process. The provider as part of the 2015/16 contract has agreed to abide by the PPwT list (appendix1) and adhere to the commissioned thresholds within each procedure, where appropriate. The list clearly contains those procedures that are clinically-authorised (tick box forms) and those that require pre-authorisation through the IFR system. NWL CCG s will not pay for any procedures that the provider has undertaken without the appropriate authorisation within the agreed timeline. NWL CCG s will not agree any retrospective funding. The service continues to be co-ordinated centrally. Key contact for clinical and operational enquiries is via ppwtnw.london@nhs.net or phone Key messages new and re-iterated in the 2015/16 version include: Patient consent added onto the PPwT and IFR forms in order to process these as per the IG rules. To facilitate the clinical audit, evidence demonstrating that the patients meet the clinical threshold for PPwT procedure is to be recorded within the patient s file / clinical notes Where it is not clear from the commissioning dataset that a challenge raised is outside the scope of policy the onus is on the provider to validate and provide the relevant evidence. Acceptable evidence is defined within the document under section 1. No authorisation form received within the scheduled timeframe, (late forms) no payment. Forms are classed as Late Form where a form has been received after the published provider submission deadline. Completion date on form is the date when decision was made to treat the patient, incorporating consultation, one-stop clinics and following follow-up tests. Re-iteration of the non-retrospective funding position Challenge validation using databases where agreed by Account Teams In terms of IFR re-iteration that applications that affect a cohort of patients/population should be deemed as service developments and not IFR s and should therefore be managed through the mainstream CCG commissioning cycle. It is Provider Trusts responsibility to submit a business case to service development group for any identified cohorts. NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

6 Section 1 Planned Procedures with a Threshold (PPwT) 1.1 Planned Procedure with a Threshold introduction to policy PPwT is part of the North West London Collaboration of Clinical Commissioning Groups (CCG) effective commissioning portfolio and is a clinically driven process whereby a clinician makes a decision whether a patient meets the evidence-based thresholds for treatment as defined in the PPwT Policy (Version 3.3 December 2014).The access for treatment is either through a clinical authorisation route (PPwT form), or through completion of an Individual Funding Request (IFR) form. For IFR s the clinician would need to demonstrate clinical exceptionality as defined in section 2. Appendix1 defines the route for each PPwT Intervention. 1.2 PPwT provider roles and responsibility PPwT pertains to elective care treatment pathways. Out of scope are: Procedures undertaken through a non-elective pathway Referrals made through cancer two week wait pathway Referrals that are upgraded to cancer pathway post out-patient consultation Any procedures upon validation post challenge it is agreed is out of scope of policy for any other reason. For any challenges related to the out of scope activity, it the responsibility of the provider Trust to provide extract of the clinical letters as a part of the challenge responses. Challenge response for this category will be reviewed but the CCG medical advisor. Upon receipt of acceptable evidence these challenges will be revoked by the commissioner. Within the overall PPwT process the provider should be familiar and has agreed to adhere to the following scenarios: Where the GP has agreed the referral meets the criteria and completes a PPwT form, the provider must validate the form as part of the overall referral validation process and triaging, to ensure it is fully completed and send a copy to the central IFR team. The IFR team will validate and ensure the boxes have been completed correctly. Although the PPwT forms are authorisation to treat, should any discrepancy be identified, the referrer will be contacted within 5 working days from the date from received by the Central IFR team. It is the expectation that any re-submitted forms will need to be sent in within 15 working days upon receipt of notification from the central IFR Team. If this date is after SUS submission date, this may be raised as a challenge and will be refreshed the following month. Acknowledgement/receipt that the forms are being logged as authorised is also sent within five working days from the date of receipt of the PPwT form. Where the GP is uncertain of the definitive treatment plan and requires a specialist opinion, the patient should be seen for consultation. Once the provider clinician has established a PPwT may be necessary, it is the responsibility of the provider clinician to complete the PPwT form. A copy of the PPwT form should be sent to the central IFR team (as per address above) via a secure NHS Net account, as it will contain patient identifiable information. The date the decision to treat option on the PPwT form is to add the date when a decision to treat the patient was made NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

7 and not the original referral date. This is in acknowledgement that the decision to treat is often made, following out-patient attendance, one-stop clinic attendance, or following additional investigation. The referrer should ensure that there is sufficient evidence in the patient record to substantiate and support that the PPwT criteria have been met. Providers must ensure that there is sufficient evidence in patient records to validate and support criteria even where the PPwT form has been completed by the GP or another referrer. As part of a review process of the PPwT policy, periodic audits will be carried to ensure that the protocols are implemented, appropriately and effectively. If, during audits, it is identified as a pattern that the notes do not contain sufficient information to confirm thresholds, this will be written up as part of the audit report. The findings of the audit report will be taken forward by the CCG commissioners as part of the Clinical Quality Meetings. Where the patient either does not meet the criteria but there may be a case for clinical exceptionality, or for the cases that are defined on the PPwT Index Sheet to be reviewed on an exceptional basis, the provider clinician may complete the NWL CCG IFR Form (Appendix2). The forms are available on via the NWL CCG websites, or can be obtained by ing ppwtnw.london@nhs.net Any incomplete (i.e. thresholds not fully completed or with missing parts of minimum required dataset such as NHS Number, Hospital number/pas number, Date of decision to treat, GP Practice code and Practice name, CCG name etc.) PPwT forms will be returned to the provider within five working days from receipt by the central IFR team with the expectation as appropriate re-submitted completed form within 15 days. Any forms received after the SUS deadline, will be regarded as late and therefore unauthorised activity. Providers will receive an from the central IFR team notifying them of this. In summary, the PPwT form is the authorisation to treat and providers will not receive payment if one has not been completed and sent to the central IFR team at the time the decision to treat is made and within the scheduled timeframe. IFR forms however require pre-authorisation and, in some instances, will have to be presented to the IFR panel or decisions will be made at IFR clinical triage meeting within 28 working days from the date all required information is received by the central IFR team. Providers should always await the outcome of the IFR decision before commencing or advising patients of treatment. If however a case becomes clinically urgent, providers should treat according to their own internal protocols but at their own financial risk. IFR panel decisions are provided within 28 working days for non-urgent applications and within 3 working days for clinically urgent applications from the date of receipt of all required information. 1.3 PPwT Authorisation and Challenge process The Clinical Commissioning Group (CCG) budget holder will only be obliged to reimburse providers that have carried out treatments covered by the PPwT policy if: appropriate PPwT criteria have been met, and this is adequately recorded in clinical notes and, NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

8 Related PPwT form has been submitted prior to starting treatment by the agreed published deadline. If a provider elects to provide such treatment without first obtaining an approval code (IFR s) or completing and submitting a PPwT authorisation form at the time of decision to treat, then they do so at their own financial risk, even where it can subsequently be proven that the patient meets the PPwT criteria and would have been entitled to the treatment. North West London CCG s do not fund retrospective funding requests under these circumstances. Authorisation to treat will be either by: Receipt of a completed PPwT threshold form as part of a referral from general practice, which has been validated by the provider following decision to treat. The Provider Completing a PPwT threshold form following a decision to treat and a copy sent to the IFR team. Just to re-iterate, the central IFR team will validate and notify the referrer within 5 working days of any discrepancies and send an acknowledgement when forms have been accepted or rejected. Providers have 15 working days to re-submit relevant completed forms. Should this go past the monthly cutoff date, this may appear as a challenge, but should be reconciled as part of the challenge process where valid forms will be revoked. To allow some flexibility - Providers can send the completed PPwT forms to the central IFR team in specialty or weekly batches, as long as they are within the month-end (SUS) timetable as defined below in table1. If forms are received after the dates within Table1 they will be classified as late submissions and therefore not included in the month end authorisation. This will be subject to challenge as unauthorised through the contracting process. Following the monthly defined submission date, the central IFR team will send all the activities handled in relation to IFR and the PPwT to NWL CCG s Information Team. The PPwT applications held on the central database will be validated against SUS data for that reporting period. Any activity presented via SUS that does not have an authorised PPwT form and has been checked and validated as genuine PPwT activity, (as far as possible) will have a challenge raised against it. This process is supported by robust internal validation to remove any challenges that do not fall within the remit of the PPwT policy and any non-applicable procedures that share the same codes as PPwT policies as far as the SUS commissioning dataset permits. It is recognised however that based on the commissioning SUS dataset, despite the validation it is not always possible to identify procedures that sit outside the scope of policy and have been challenged. It is for the provider to provide evidence that any challenge raised sits outside the scope of policy. Evidence can be via clinical notes or for cancer pathways/exemptions or via a database such as Open Exeter or other local cancer databases. Evidence can also be via extracts of clinical letters. Using a database for validation must be agreed with the Account Team as part of the formal response process. NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

9 As per other NHS NWL challenges, it will be the responsibility of the provider to produce the evidence that an authorisation form was accurately completed in the month the decision was made and before the submission deadline defined in table1, or that the challenge was not applicable. PPwT Challenge Guide Given below are the tables providing the detail on type of challenges raised by the central IFR Team and the detail on evidence expected from the Trust for each category: Challenge Category - This table shows the areas/ categories for which challenges are raised by central IFR team Late Form No authorisation form received within the scheduled timeframe, (late forms) no payment. Forms are classed as Late form when the date of decision to treat on the submission form does not coincide with the published provider submission deadline for each month upon receipt. Incomplete Forms Where a part of minimum dataset is missing from the PPwT form submitted to the IFR Team e.g. NHS Number, Hospital Number, a Valid GP practice code, Date of Decision to treat and threshold tick boxes Declined Threshold Not Met These are the forms where minimum data set is provided but the Threshold is not met. No payment for the forms that were declined due to threshold not being met. Forms Not Sent Any activity that is coded as PPwT but where the relevant PPwT form was not submitted to the PPwT Team Response Category - this shows the acceptable evidence/response expected from Trust against each challenge category Late or Incomplete Forms Declined Threshold Not Met Where the challenge has been issued due to late or incomplete forms, we do not normally expect a response. It is expected that these challenges will be accepted by the Trust and credit notes raised. Where a challenge has been raised for forms that are declined due to threshold not being met; it is expected that these challenges will be accepted by the Trust and credit notes raised unless the Trust can provide NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

10 evidence of resubmission of this form with threshold met within 15 working days after the first submission date. Form not Sent This is further divided into four categories as to why the forms were not submitted or required. 1. Outside Scope - Cancer Pathway A PPwT form was not necessary because the patient was upgraded onto a cancer pathway post Out-patient consultation and the dataset given to the commissioners could not identify this 2. Out of Scope Other A PPwT form was not necessary because the patient was on a pathway that is for an intervention that for some indications sits outside PPwT Policy 3. Administrative Challenge The procedure is identified by both Provider and Commissioners as a PPwT but the commissioners have no evidence that a form was received 4. Script Challenge A PPwT procedure has been challenged but this should have been picked up via the automated script i.e. cancer 2ww, non-elective, 2nd stage bilateral, commissioner misallocation. Expected Acceptable Evidence for Challenges marked as Form not Sent 1. Outside Scope - Cancer Provider Trust to submit one of the following: Pathway Copy of clinical letter or an Extract from clinical letter demonstrating how the spell is out of scope of PPwT Policy Agreed Extract from Cancer Database demonstrating it is a cancer patient or the procedure was carried out due to suspected cancer 2. Out of Scope Other Provider Trust to submit : copy or an extract from of clinical letter or record defining scope of treatment for Medical Advisor to review 3. Administrative Challenge Provider Trust to submit as evidence: Case Reference number provided by the IFR team (most preferable option) Copy of acceptance received from IFR team A copy of the form will not be acceptable evidence. 4. Script Challenge Feedback on Challenge spread sheet from Provider to trigger SUS data review. Highlight any codes that are to be removed from NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

11 the script due to being out of scope of PPwT policy To ensure that resolution of challenges is timely and reasonable, there will be: one iteration of the Challenge (sent by CCG Central IFR team to Provider); Response (Once from Provider to IFR Team as per SUS timetable); Final Review of Trust response (once by CCG IFR team) At this point a recommended final position would be sent to the Account Director by the IFR team. Please note that the Trust can only submit their responses ones as per the SUS timetable given below for the monthly challenges and NO further responses will be accepted once the final recommendations to close the challenges are submitted by the IFR team to CCG Contracts team. If the Provider is not in agreement with proposed final challenge figures, agreement will need to be reached via discussion at the relevant contractual meeting usually the Finance and Information Group. NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

12 Table1 PPwT Challenge Schedule A B C D E F G H Month no. Month Trust Final Submission of PPwT forms SUS Inclusion Point PPwT team submission to CSU 1st Reconciliation Point CSU challenges for PPwT issued by Provider response to data challenges Post reconciliation SUS inclusion point Final reconciliation Point M1 Apr-15 19/05/ /05/ /06/ /06/ /06/ /06/ /06/ /06/2015 M2 May-15 15/06/ /06/ /06/ /06/ /07/ /07/ /07/ /07/2015 M3 Jun-15 15/07/ /07/ /07/ /07/ /08/ /08/ /08/ /09/2015 M4 Jul-15 17/08/ /08/ /09/ /09/ /09/ /09/ /09/ /09/2015 M5 Aug-15 15/09/ /09/ /09/ /09/ /10/ /10/ /10/ /10/2015 M6 Sep-15 15/10/ /10/ /10/ /10/ /11/ /11/ /11/ /11/2015 M7 Oct-15 16/11/ /11/ /11/ /11/ /12/ /12/ /12/ /12/2015 M8 Nov-15 14/12/ /12/ /12/ /12/ /01/ /01/ /01/ /02/2016 M9 Dec-15 18/01/ /01/ /02/ /02/ /02/ /02/ /02/ /02/2016 M10 Jan-16 15/02/ /02/ /02/ /02/ /03/ /03/ /03/ /03/2016 M11 Feb-16 15/03/ /03/ /03/ /03/ /04/ /04/ /04/ /05/2016 M12 Mar-16 18/04/ /04/ /05/ /05/ /05/ /05/ /05/ /06/2016 Page of 41

13 1.4 PPWT validation process The PPwT authorisation process is run by the centralised IFR team who validate all forms received by referrers, within the agreed specified five working days, using four subprocesses (highlighted in the flow charts). Forms that are received on an individual basis Forms received in batches Late Submissions (as defined in table1) Incomplete thresholds As stated previously North West London CCG s will not accept any PPwT forms submitted late after the dates defined in table1 previously. The following flow charts highlight the processing of PPwT forms. Generic PPwT process flow chart 1 Page of 41

14 PPwT batch process PPwT batch late submission process flow chart 2 NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

15 1.5. PPwT provider management report Following feedback from providers, a monthly provider management report is produced that provides a summary of the forms received on a provider basis, by Speciality and associated status. It is the expectation that this report will be used as a tool to provide central feedback, in recognition that the forms are sent logistically from a number of individual areas internally. This will be a reference tool only and cannot be used as a conduit for retrospective funding PPwT audit process PPwT policy implementation will be supported by an in-year audit. The PPwT audit is intended to review PPwT documented compliance with the PPwT policies, identifying patterns and learning lessons for improvement in process. Ad-hoc audits may be undertaken with mutual agreement where a need is identified e.g. over-performance, coding or challenges close down validation. Clinical Quality Audit A sample of patient notes relating to approved PPwT procedures will be reviewed to To identify if PPwT procedures have been carried out in line with agreed threshold recommendations To confirm if IFR process is being followed. To audit that evidence relating to PPwT thresholds is recorded in the notes To identify PPwT procedure thresholds that may require review. Timing Clinical audit will be carried out once a year. Dates will be agreed with providers. It is anticipated that audits will be undertaken in the following months. Q3 and Q4 October 2015 to November 2015 Reports The audits will report on: Compliance with PPwT thresholds for approved procedures Commissioners will act on the findings of the audit within contractual frameworks. Audit results will be reported to the NWL CCG Clinical Quality Groups. Communication with providers A detailed audit framework will be agreed with providers at the beginning of the year, outlining detail such as sample size, selection of procedures to be audited and extrapolation agreement. The list of procedures will be agreed with providers for each audit. Providers are expected to nominate audit leads who will liaise with the NWL collaboration of CCGs audit team to put processes in place for audit PPwT key summary notes for providers PPwT 2015/16 key notes: Provider clinicians are expected to complete a PPwT threshold form to determine that a patient meets the criteria following a request for a specialist opinion. NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

16 PPwT forms received from general practice should be validated and a copy forwarded on to the PPwT team with the usual provider submissions. A copy of the form to be sent to the PPwT generic via an NHS.net account at the time the decision is made. The date on the PPwT form should be the date the decision to treat was made not the original referral date Provider clinicians will need to complete an NWL Clinical Commissioning Group IFR application forms should the patient not meet the criteria, but it is felt there are clinical exceptions for treatment. PPwT is for planned procedures only and not for non-elective or two week wait referrals. PPwT forms are authority to treat if patients meet the threshold. Forms should be completed and sent to the IFR team at the time the decision is made. North West London CCG s will not accept any retrospective PPwT forms. A provider management report will be sent to Provider Leads on a monthly/quarterly basis. Audits will be undertaken on a twice yearly basis and Providers should make sure thresholds are documented in the notes. NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

17 Section 2 Individual Funding Requests 2.1 Individual Funding Requests (IFR s) overview These treatments are not normally funded by the NHS, or are only funded in certain exceptional circumstances that are reviewed on a case-by-case basis. Such cases, involving patients with unusual or unique clinical factors, are considered by a panel set up to handle IFR. These also include PPwT s where the patient does not meet the threshold but demonstrates significant clinical exceptionality, as per standard IFR. There is a North West London wide IFR Service for processing all IFR applications for the eight NWL CCGs. (Appendix2). To meet the definition of exceptional clinical circumstances there must be some unusual or unique clinical factor about the patient that suggests that they are: AND Significantly different clinically to the group of patients with the condition in question and at the same stage of progression of the condition. (i.e. compared with the same age-, sex-, disease- specific cohort of patients). An example would be an exceptionally indolent or other variant of the illness or host factors such as an unusual genetic make-up that will make them exceptionally responsive to treatment. Likely to gain significantly more clinical benefit from the intervention than might be expected from the average patient with the condition. An example will be where a treatment is likely to be more clinically effective as well as cost effective on an individual patient. However, the fact that a treatment is likely to be efficacious for a patient is not, in itself, a basis for an exemption. If a patient's clinical condition matches the 'accepted indications' for a treatment that is not funded, their circumstances are not, by definition, exceptional. It is for the requesting clinician (or patient) to make the case for exceptional status. It should be noted that social value judgments are rarely relevant to the consideration of exceptional status. The IFR Panel will NOT make a decision to fund a patient where by so doing a precedent would be set that establishes new policy (for example, in situations where the patient is not, in fact, exceptional, but representative of a group of patients). In such cases, if the IFR Panel feels strong evidence has been provided in support of a particular health technology (treatment or intervention); it would make a recommendation to the Service development group to consider the health technology within its planned priority setting and service development process. Decisions to fund an exceptional case will not at any time establish precedence even for people with apparently similar conditions. 2.2 IFR Provider Role and Responsibility Responsibilities of the requesting clinician An IFR may be submitted by an NHS consultant, a GP or, or an equivalent autonomous clinical practitioner provided s/he will be responsible for administering the treatment. Due to NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

18 the sensitive nature of the information being sent, applicants are required to make IFR applications between NHS.net (or similarly encrypted) accounts. Due to the level of detail required in the application form it is unlikely to be known by the patient and therefore applications from individual patients will not be accepted. However patients can submit a written supporting statement with the application if they wish to do so. The IFR panel needs to be assured that an NHS clinician can describe precisely why they consider the treatment to be appropriate for the particular patient and that an NHS provider has agreed to carry out the treatment for which funding is requested. The requesting clinician is required to affirm that they have discussed the proposed treatment with the patient (or have offered such a discussion) before the application is made for funding on his/her behalf. It is the requesting clinician s /GP s responsibility to gain and document consent from the patient prior to the submission of the application as indicated in part 1 of the IFR form. The requesting clinician / GP are responsible for recording patient s consent within patient s individual health records. The requesting clinician / GP must make the patient aware of the implications of embarking on this process, particularly that it may take some time before the request can be decided and, if the patient is considering privately funding the requested treatment while the IFR is being considered that no retrospective funding is available, even if the IFR is approved. The patient must be also be made aware that funding is often given for one course of proposed treatment, in order to allow for effects to be assessed, and that further courses of treatment will require further CCG consideration and may require further IFR. It is the responsibility of the requesting clinician to ensure that all the required information is submitted by the published cut-off date, including copies of full length articles (i.e. not abstracts) or identifying websites where these articles can be freely accessed, where published evidence is referenced to support the case. IFR application forms are designed to capture all material information to enable due consideration according to this policy. Minimum dataset / information requirements are: Patient s Consent for sharing their details with IFR Team and for IFR Team to contact relevant healthcare clinicians regarding their application. Details of patient s registered GP & CCG name Clear reasons for clinical urgency (If relevant) Evidence demonstrating clinical exceptionality of the patient s case including an explicit statement demonstrating how the patient is significantly different from the general population of patients with similar clinical condition and how they are likely to gain significantly more benefit than might be expected from average patients. Clear details of the diagnosis / clinical condition for which treatment is requested Full details on treatment requested such as name, duration, dose and frequency along with the details on how response to the treatment will be requested? What will be considered as a successful outcome? Supporting evidence on safety and clinical effectiveness of the requested treatment. This could be in form for publishes case studies or journals Specify expected benefits of the treatment in patient for whom it is requested Details of on-going and any previous interventions the patient has received for the condition including duration, dose and reasons for stopping the treatment List potential alternative treatment options available for the patient List the standard treatment and reasons why it is not appropriate for the patient Total Cost (including VAT) of the requested treatment and available alternative treatments NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

19 Submission of the complete information will minimise avoidable delay in the assessment process. Applications with a part of minimum dataset missing will be returned to the applicant with a request for completed form. It is the responsibility of the requesting clinician to ensure that treatment urgency is adequately stated and explained and the 3-day urgent process is appropriately utilized. In all cases where a request is received and the requesting clinician is not available to address queries in a timely manner, the IFR team will escalate to the Medical Director at the Trust. The requesting clinician should not commence treatment until they have had confirmation of the outcome of IFR Panel in writing and subsequent authorisation code where applicable. The CCG will not fund retrospective cases. Urgent applications The IFR process is designed for planned care and cannot give adequate consideration to cases in less than 3 working days. However, the North West London CCGs recognise that there will be occasions when an urgent decision needs to be made to consider approving funding for treatment for an individual patient outside the CCG s normal policies. In such circumstances, an urgent decision may have to be made before a panel can be convened. The following provision apply to such a situation: An urgent request is one which requires urgent consideration and a decision because the patient faces a substantial risk of death or significant harm if a decision is not made before the next scheduled meeting of the IFR panel. Urgency under this policy cannot arise as a result of a failure by the clinical team expeditiously to seek funding through the appropriate route and/or where the patient's legitimate expectations have been raised by commitment being given by the provider Trust to provide a specific treatment to the patient. In such circumstances the North West London CCGs expect the provider Trust to proceed with treatment and for the provider to fund the treatment. Provider Trusts must take all reasonable steps to minimise the need for urgent request to be made through the IFR process. If clinicians from any provider Trust are considered by the CCG not to be taking all reasonable steps to minimise urgent request to the IFR process, the CCG may refer the matter to the Trusts Clinical Medical Director as a governance risk.. The referring clinician for an urgent application should: Identify the application as urgent and inform the IFR team of the clinical rationale for the urgency via completing urgent Form along with the IFR Form Ensure their contact details are available to the IFR team so that the Medical advisor or the IFR lead with delegated responsibility within the IFR team can discuss the urgency and an accelerated timeline can be agreed should this be considered to be appropriate. Before considering an IFR as urgent careful consideration will be given as to whether sufficient information is available for the IFR Panel to make a decision without compromising any of the principles upon which decisions should be made Submitting an urgent IFR form does not warrant a case to be considered under the timeline for clinically urgent cases. Upon receipt of an urgent application, case will be reviewed by the Medical advisor. Drug cases will be reviewed along with the Medicines Management Advisor and non-drug cases with IFR Knowledge & Delivery Manager in order to decide if case is to be accepted as an urgent case. NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

20 Upon review, if they decide that the case does not meet criteria for an urgent application then the applicant will be informed of this and the case will be considered under the timeline for non-urgent IFRs (i.e. 28 working days from the receipt of all information) *Please do not withhold treatment if treatment is clinically necessary pending funding approval. However, treating without finding approval will be at the Trust s own financial risk IFR process screening: When an IFR is submitted by an NHS consultant or equivalent practitioner, the national guidance requires the submission to be approved by the designated representative of the provider. In the case of an IFR for a drug this is likely to be a designated Chief Pharmacist or Trust s Drugs and Therapeutics Committee (DTC) meeting. For other treatments, it may be the Multidisciplinary team meeting (MDT) or Referring clinicians and specialists must ensure that any new treatment being requested has been considered by the provider s Drugs and Therapeutics Committee (DTC) or New Drugs Panel (NDP). Referring clinicians and specialist must ensure that, where the patient s has been discussed by a multidisciplinary team, the MDT minutes are sent with the IFR. The IFR panel does not normally consider requests where there is no evidence that such a clinical governance system is in place. When an IFR is submitted by a GP or dental practitioner, it is expected that they will have fully considered whether this is the correct process to use Validation check for completeness: Referring clinicians should provide copies of all articles or publications referred to as evidence of the intervention, or give details of websites which provide open access to the full versions of the articles concerned. If such copies or website details are not given then clinicians will be advised to submit these within a set timeframe and that this may delay the processing of the IFR. The IFR Service will establish mechanisms for accessing up-to-date information on the CCG s contracts with provider Trusts, commissioning policies, reviews of policy in hand at national, regional and local level and other information likely to be relevant to the Panel triage process. At admin Triage stage all applications will be reviewed by the IFR Administrator for completeness of minimum dataset and clarity. In case a part of the minimum data set is missing or the form is not readable due to handwritten scanned submission, these are returned to applicant advising reason for non-acceptance. Applicant can resubmit the forms after adding missing information electronically. All complete applications are logged, acknowledged and added onto the agenda for weekly Clinical triage meeting Management of an urgent IFR IFR should only be dealt with urgently where there is a clear clinical reason why the patient s health will be significantly compromised by waiting until the next scheduled IFR NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

21 panel meeting for a decision to be made. It is expected that only a small minority of IFRs will be dealt with in this way, and these will usually involve life-threatening conditions. It is for the clinician submitting the request to specify reasons for urgent status to be assigned. It is expected that an urgent decision can be provided within 3 working days of accepting an urgent request provided that An Urgent IFR Form (Appendix 3) has been submitted alongside the standard IFR form (Appendix 2). Reasons for clinical urgency are clearly stated and criteria on the urgent form are met. All relevant information is submitted by the clinician for panel consideration and all follow up queries are addressed IFR will not be treated as urgent on the basis that waiting until the next IFR panel is inconvenient for the patient or requesting clinician or on the basis that the patient will otherwise make a complaint. An urgent decision will be made by a virtual panel with reference to the Ethical Framework (NHS NWL Ethical Framework for Decision Making V2.0 Nov 2011) and the consensus method for decision-making, as would be the case for regular IFR. The decisions available to an urgent panel are: the request will be funded without conditions the request will be funded with conditions attached the request will not be funded All requests for urgent cases and must be acknowledged within 48 hours of request in line with national guidance. Conditional approval IFRs may be approved for funding subject to conditions. In some cases the Panel will need to be advised of the patient s status at an interim point, in order that they can approve a second phase of treatment. For example, a clinician may request six cycles of a treatment however the IFR panel may agree to fund three cycles and that funding for a further three cycles will be conditional upon the patient s response. The panel will require a report detailing the response observed after the first three cycles Withdrawal of IFR: IFR can be withdrawn at any time by written notice from the requesting clinician or from the patient. The panel will note that a submission has been withdrawn at the next available meeting. For example, it may be necessary to withdraw if the patient opts for an alternative course of treatment, to fund treatment privately, or if the patient dies 2.3 IFR key summary notes for providers IFR summary highlights: There is a NWL-wide IFR Service for the receipt and processing of IFR applications across the eight NWL CCGs. It is the responsibility of the requesting clinician to ensure that all required information is NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

22 submitted by the cut-off date and that the application and process is discussed with the patient. In cases where further information is requested from the applicant, the IFR Team will send two reminders within the set time scale and If the requested information is not submitted by the deadline, the case will be closed by the IFR team upon clinical triage until the requested information is received. IFR s will only be treated urgently where there is a clear clinical reason why the patient s health will be compromised by waiting for the next weekly scheduled panel. The maximum service KPI from receipt of full application to decision by panel is 28 working days. All IFR applications must be completed on the NHS NWL IFR application form (appendix2) We welcome feedback on the content of this Provider Service Framework, via ppwtnw.london@nhs.net 2.4 Policy /Service Development Group The IFR Standard Operating Procedures for the 8 NWL CCGs state that the IFR Panel will not make a decision to fund a patient where by so doing a precedent would be set that establishes new policy (for example, in situations where the patient is not, in fact, exceptional, but representative of a group of patients). In such cases, if the IFR Panel feels strong evidence has been provided in support of a particular health technology (treatment or intervention); it would make a recommendation to NWL Clinical Commissioning Groups to consider the health technology within its planned priority setting and policy development process. This enables a collective evidence review and provides an overall basis on whether the intervention should be funded and provides a strong evidence based position when CCG s decide not to fund an intervention. Policy/Service Development Group Aims and Objectives: To develop a clear overarching standardised policy framework NWL CCG s funding policy development, including a priority work plan To review the recommendations from local clinicians via workshops and e-groups To reduce similar cases going to IFR Panels by developing clear policies covering the most common intervention, ensuring consistency in the decision making To protect the NWL CCG s from legal challenge as a result of funding decisions made at IFR Panels through the development of fair, robust, evidence-based policy To provide an estimate of financial impact of any policies developed To recommend to Commissioning those areas which should become service developments rather than form the basis of new or updated funding policy To use the NWL CCG Ethical Decision Making Framework to underpin the Group s processes of developing new funding policies. To review existing PPwT Policies based on new published evidence i.e. NICE To consider proposals and business cases for new service developments submitted by providers. Impact for Provider Trusts The North West London Clinical Commissioning Groups have agreed the following approach: The Policy Development Group will look at areas where patterns of IFR applications have already been identified (table1). The timetable for review will be shared with Provider Trusts once agreed and Trusts will be invited to submit evidence or attend workshops where relevant to contribute to NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

23 the business case. Trusts will be notified of any further IFR cases received that are part of identifiable cohort, and can alternatively submit a service development/business case proposal to support the PGD in its decision making (app1). These where possible should be submitted in line with the commissioning cycle/contracting round. This is to ensure it is included in the prioritisation framework for 2015/16 and avoids any potential in year variation. Further patterns of IFR cohorts identified will be added onto the PDG work plan as agreed by the group. Once a trust has been notified that a cohort has been identified, no further IFRs should be submitted unless there are a unique set of individual clinical circumstances that can be deemed as exceptional. The IFR clinical triage team will triage/assess and bounce back any referrals that it is deemed are part of the cohort. Trusts should discuss this locally with their contracting teams at the relevant Clinical Quality Group meeting and highlight any issues and risks. Feedback and questions can be submitted directly to ppwtnw.london@nhs.net Appendix 4 includes a list of treatments and drugs that are deemed as service development for 2014/15 NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

24 Section 3 - Appendices Appendix 1 - Index of Planned Procedures with a Threshold (PPwT) and procedures requiring Individual Funding Requests (IFR) Ref. Policy Name IFR PPwT only threshold 1 Abdominoplasty or Apronectomy 2 Adenoidectomy (policy remains please see tonsillectomy / grommet ppwt form) 3 Benign skin lesions 5 Breast prosthesis removal or replacement 6 Breast reduction (Reduction Mammaplasty) 7 Carpal tunnel surgery 8 Cataracts 9 Chalazia 10 Chronic Fatigue Syndrome 11 Circumcision 12 Complementary and alternative therapies 13 Cosmetic Policy ( e.g. skin procedures, breast procedures and general cosmetic surgery policies see full list overleaf) 14 Dilatation and curettage 15 Dupuytren s disease/contracture 16 Female sterilisation reversal 17 Functional Electrical Stimulation 18 Ganglions 19 Grommets in Children 21 Haemorrhoidectomy 22 Hair depilation in hirsutism (use of lasers) 23 Hernias in adults 24 Hip replacement 26 Hyperhidrosis treatment with botulinum toxin 27 Hysterectomy for menorrhagia 29 IVF including Cryopreservation 30 Knee arthroscopy/wash out 31 Knee replacement 32 Lymphoedema and Lypoedema In Patient & Surgical Treatments 33 Magnetic Resonance guided Focused Ultrasound (MRgFUS) for uterine fibroids 34 Male sterilisation reversal 35 Open MRI 36 Pain management programmes 37 Penile implants 38 Polysomnography 39 Septorhinoplasty 40 Short sightedness laser surgery 42 Tonsillectomy 43 Trigger Finger/Tenosynovitis 45 Uterovaginal prolapse 46 Varicose veins NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

25 Note: item number 28, Hysteroscopy Policy has been removed from the PPwT Scope. Following a clinical audit it was decided that there was limited clinical value in monitoring this procedure; therefore all referrals for this procedure are now routine. IFR Cosmetic Policy contains: Skin Procedures Refashioning of scars and keloids Skin graft for Scars Skin Resurfacing, including for acne scarring light or laser therapy for aesthetic reasons Procedures for tattoo removals Procedures to correct rhinophyma Procedures for removal of benign skin lesions Surgery for removal of chalazia Breast Procedures Breast Augmentation Mastopexy Breast reduction Surgical treatment for Gynaecomastia Nipple Inversion Procedures Breast Prosthesis Removal and Replacement Revision Mammoplasty General Cosmetic Procedures Face and brow lift Blepharoplasty Rhinoplasty Pinnaplasty Earlobe Repair Liposuction Body contouring including Thigh lift, buttock lift, arm lift Belt lipectomy Abdominoplasty Hair Grafting Hair depilation for hirsuitism Labiaplasty Varicose veins procedures Plastic operations on the umbilicus NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41

26 Changes to the PPwT Policy 2015/16 PPwT Policy Review As a part of the periodic review, the current PPwT policies have been updated to further refine definitions following stakeholder feedback and in some instances been updated to reflect latest evidence reviews that have been agreed by the Clinical Commissioning Groups. A summary of key changes include: The reviewed PPwT version 3.3 forms were released for use on 5th November 2014 and can be accessed via the 8 NW London CCG websites: As per the recent Information governance changes, Patient consent is required for the IFR team to access person confidential data (PCD). All PPwT and IFR application forms now include a patient consent section for GP/Clinicians to indicate patient consent has been given regarding the sharing of their patient details with the NWL IFR Service. Applications (IFRs and PPwT forms) will be only be accepted with PCD by the IFR Service if patient consent section on the form is completed and in good faith that informed patient consent has been given and documented in individual patient s health case record. Amendments to Policy Wording: Abdominoplasty or Apronectomy Revised wording: Abdominoplasty and apronectomy procedures will not be funded for cosmetic reasons. Carpal tunnel surgery Revised wording: severe symptoms, interfering with activities of daily living. Dates will be required. Circumcision Revised wording: Circumcision will only be funded where one of the following criteria is met: (see full criteria) Dupuytren s disease/contracture Revised wording: A fixed flexion deformity between 0 and 30 degrees at the PIPJ where either there is: (see full criteria) Open MRI Revised wording: In patients who are obese and therefore cannot fit comfortably in a conventional MRI Penile implants Revised wording: Exceptions to this policy are patients with severe structural disease, where first and second line treatments may not be effective, are conditions such as: (see criteria) Amendments to Policy Criteria Breast prosthesis removal or replacement -Policy criteria revised and statement added: If the above criteria for funding have not been met, funding may be considered via the Individual Funding Request route where there are exceptional clinical circumstances present NWL CCG PPwT & IFR Provider Service Specification document 2015/16 (V6 draft) Page of 41