Market engagement day introduction DRAFT may be subject to change

Transcription

1 Market engagement day introduction DRAFT may be subject to change Professor Sue Chief Scientific Officer for England SRO for Genomics, NHS England Sep 2017

2 What will be covered today 1. Brief reminder of the background and context 2. Responses to feedback from previous engagement sessions 3. Overview and key points of note in the genomic laboratory service specification 4. Next steps 5. Key related issues

3 NHS Genomic Medicine Service: background and context

4 NHS Genomic Medicine Service: Our aim A national genomic medicine service driving personalised treatments and interventions with consistent & equitable access across the country Focus on improving quality and reducing variability, setting standards and driving consistency, economies of scale and affordability Routine care and treatment will be closely linked through to clinical research, academia and industry to support ongoing learning from genomics and promote the development of new treatments and interventions

5 Assembling all the building blocks NHS Genomic Medicine Service underpinning personalised treatments and interventions Genomic Medicine Services providing population-based care Informatics architecture & data store National Lab Network inc Genomic Laboratory Hubs Whole Genome Sequencing provision National Testing Strategy from single gene WGS outlined in directory Clinical Interpretation Pipeline Workforce development inc upskilling of existing staff Industry/ academic/ international partnerships supporting ongoing research & development through clinical care Advances in genomic and informatics technologies and in other next generation diagnostics

6 Broader policy perspective: UK Life Sciences Industrial Strategy VISION: Build life sciences industry into a global hub for biomedical research SCIENCE GROWTH NHS DIGITAL Key elements of the Strategy is to strengthen the potential of partnership between industry and the NHS and to create the Health Advanced Research Programme to drive moonshot initiatives Building on strengths of research & translation Enabling industry growth across UK Enabling industry growth across UK Collaboration on real world technology & new research SKILLS: Ensuring the UK has the talent, skills and workforce to deliver future success REGULATION: Securing patient safety and ensuring an effective ecosystem for life sciences GLOBAL: Working with the best global partners to build collaborations and inward investment Joint programme between Government, Industry & NHS

7 Future genomic operating model NHS England Genomics Unit data NHS Genomic Medicine Service NHS Genomic Laboratory Infrastructure consent and data samples, consent and data Genomics Laboratory Hubs genomics local laboratories data advice and/or referrals data patient referrals from clinical services & providers samples, consent and data extracted sample KEY NHS WGS provider(s) contractual mgmt commissioner NHS England NHS England & NHS Digital NHS England & Genomics England Genomics England consented, de-identified data data NHS data warehouse Hub A Local labs Hub B etc reports portal storage of NHS WGS VCFs Clinical Interpretation Service UK Genomic Knowledge base Genomic technology evaluation function other research and industry data patient identifiable data de-identified data expertise & advice 8

8 Genomic laboratory procurement aim We are commissioning: National network of provision a world-class resource for the NHS Delivery of a single uniform national test directory delivered through standard operating procedures to ensure quality and comparability Equitable & consistent access to testing provision In practice, this future system will influence, innovate and strategically prioritise the future delivery of genomic & personalised medicine The National network of genomic laboratory hubs will deliver: clear accountability clear assurance locally determined solutions to respond to specification clear contractual arrangements with NHS England and any other subcontractors clear interfaces with national bodies & WGS provision Informatics solution Procurement process structured to drive the establishment of a world-class resource for the NHS delivering cutting-edge technology for patient benefit

9 PRE-PROCUREMENT FORMAL PROCUREMENT The procurement timeline Jun 17 Issue PIN notice listing the key requirements for the future infrastructure Jul 17 Market Engagement Events Aug 17 Bilateral discussions with potential bidders Sep 17 Discussion with potential bidders Issue draft specification Oct 17 Discussion with potential bidders Issue further draft of the specification Nov 17 Bilateral meetings with potential bidders Nov 17 Issue formal ITT and final service specification Feb 18 Deadline for Final Bids & shortlisting March 18 Panel assessments & contract award April October 18 Mobilisation Pre-procurement process designed to test and refine key requirements as currently understood Other key milestones for genomic medicine service Consultation on testing strategy Publication of testing directory Genomic Medicine Service infrastructure

10 Responses to feedback

11 Feedback and response (1/2) Feedback Response Contract length Intention for a minimum term of five years Lot boundaries Process underway to fine tune boundaries in all lots to reflect patient pathways & flows Further work to clarify sensible boundary between W Midlands and South West & Wessex Lead for Education and Training Education and Training lead will be specified as part of the workforce requirements Transition planning Bidders will need to provide a transition plan to full operational status in line with the timetable for mobilisation The plan will need to cover transitional risks and mitigation actions and assurance that services to patients will not be affected during the service reconfiguration stages

12 Feedback and response (2/2) Feedback Response Provision of reagents Intention for a national framework/approach Further details to be provided in due course Suggestions for inclusion on this list welcomed Contracting and subcontracting arrangements Update will be provided during the session Financial model Update will be provided during the session TUPE Further information will be provided at October s market engagement event

13 Overview of the genomic laboratory service specification

14 The service specification development process Service specification drafted with expert input Draft service specification to be released end of September 2017 Stakeholder engagement process opportunity to provide written feedback Draft service specification to be refined following stakeholder and market engagement event feedback Second draft service specification released October 2017 Final service specification published November 2017

15 Draft service specification contents The draft service specification will be released by end of September. The service specification includes the following sections: Scope including a description of services Care pathway and clinical dependencies Population covered and population needs Quality and outcomes Applicable service standards Glossary This is an outline of the service specification as it is currently understood. It should be noted that the requirements referred to within this presentation are not exhaustive and may change or evolve during the course of the pre market engagement period.

16 Scope of the service - Rare, Inherited and Sporadic, Acquired inclusive of Cancer and Personalised and Stratified Medicine Plan & develop workforce for now and the future Consolidate services to deliver significant efficiencies Operate within a national testing network Organisational governance and partnership arrangements Operate a coherent informatics infrastructure Promotion of research and innovation Key responsibilities of GLHs Sample collection, processing and logistics Quality management and assurance of both processes and data Technical and analytical platforms Clinical interpretation, reporting and returning of results Bioinformatics, annotation and validation

17 National and Local networks GLHs will: Work together to form part of a national network of genomic laboratories to provide a comprehensive and coordinated national genomic laboratory service that is an integral part of the planned NHS Genomic Medicine Service. Deliver a prescribed list of genomic tests, for a defined geography, as outlined in the National Genomic Test Directory during the life of the contract. If appointed as a provider of a national specialist testing service the GLH will be responsible for providing the genomic testing service for prescribed GLHs within the national network and will work with clinicians and genomic MDTs within the prescribed geographies. Participate in regular meetings convened by NHS England s Genomic Unit as part of the national network. Establish local networks of any subcontracted laboratories and designated providers for cancer genomic testing to provide a coordinated and comprehensive service across the defined geography to deliver standardised outcomes, ongoing consolidation and adoption of new technologies

18 Consolidation GLHs will: Consolidate the existing specialist genetic laboratories into state of the art, high throughput, high quality and standardised laboratories through the delivering of the majority of genomic tests for their geography, as prescribed in the National Genomic Test Directory, through a single laboratory. The GLH may then also subcontract for a specified repertoire of specialist genomic tests and/or cancer genomic tests that they cannot provide directly. Operate enhanced working practices to ensure genomic testing services are available to support the delivery of seven day services across the geography, and ensure that genomic technology platforms are fully optimised. Be responsible for ensuring quality and the ongoing review of opportunities to further consolidate networked services, based on technological advances, the changing evidence base for genomic testing and the National Test Directory.

19 Governance and oversight GLHs will: Be accountable to NHS England s Genomics Unit within an agreed governance and operational framework that will oversee the test repertoire, co-ordinate the provision new national specialised testing services, monitor performance and finance. Have in place and maintain throughout the lifetime of the contract a partnership agreement with all sub-contracted partners and designated providers for cancer genomic testing as appropriate setting out the working relationships and a sustainable operating infrastructure. Be responsible for establishing and maintaining a sustainable operational infrastructure and contracting arrangements for the geographical network inclusive of quality improvement Fulfil the membership criteria for UKGTN (or any future successor arrangements) and any additional requirements as specified by the NHS England Genomics Unit. Have a transition plan that describes how they intend to move to full operational status in line with the timetable for mobilisation. The transition plan must include transitional risks and mitigation actions and provide NHS England with assurances that services to patients will not be affected during the service re-configuration stages

20 GLH personnel GLHs will be expected to identify specific lead personnel responsible for the delivery of the service, including: Scientific Director - Consultant Clinical Scientist or equivalent with recognised national/international reputation in the field of genomics with clinical service knowledge and experience Medical Director or associated clinician Cancer Genomic Medical lead or associated clinician Operational Director (who works within the hub, a Consultant Clinical Scientist or equivalent with scientific operational management knowledge and expertise) Data and Informatics Director Business Manager Contracting & Finance Manager Lead Scientist for rare disease Lead Scientist for Cancer genomics Bioinformatics Lead Quality Manager Service lead within each provider Education and Training Lead Plus named individuals as - Caldicott Guardian - Senior Information Responsible Officer

21 Testing service provision National Genomic Test Directory Core tests (non-wgs) carried out by all GLHs National specialist tests (non-wgs) carried out by assigned GLH(s) working in network WGS tests GLHs co-ordinate test referrals & perform DNA extraction & defined QA & plate samples for submission to WGS provider NHS England to contract for sample transport to WGS provider Other testing eg Rapid PoC for cancer may be delivered in the geography through separate arrangements annual review

22 National Genomic Test Directory National Genomic Test Directory Defines all genetic and genomic tests available through the NHS in England Sets out the What, Where, Why, Whether, When & How of each genetic test Directory identifies key information for each test including: Clinical indication Eligibility criteria Where in the clinical pathway - including who can order the test Any exceptions required to standard specification Test scope (eg SV, CNV, methylation) Region type (eg Single gene, panel, genomewide) Key genes or loci Technology (eg Single gene, Microarray, Large Panel, WES, WGS) Turnaround time requirements The directory is in the process of being costed to inform the final testing approach

23 Proposed approach in Rare disease Technology Number of Indications The directory will inform which technology will have to be used in each clinical indication. From single gene to WGS ~300 indications are expected to be included in the final version Tests are grouped into 18 technology categories GLHs will perform tests up to level of WES DNA extraction and sample processing is recognised as a separate activity Highly specialised service testing will not be included in the directory Initial estimates based on working model Number of Samples WGS WES Large panel Small panel Single gene sequencing Targeted mutation testing STR testing MLPA or equivalent Microarray Common aneuploidy testing Karyotype FISH 0 0 DNA repair defect testing Methylation testing UPD testing 0 0 X-inactivation testing Identity testing DNA extraction TBD TBD

24 Proposed approach in Cancer In cancer, the approach will be to move the vast majority of testing to panels There will be a phased introduction approach moving to larger panels and WGS Bespoke panels have been proposed, with essential and extended targets Pan-solid tumour Panhaematologi cal Panpaediatric Essential DNA targets Essenti al RNA targets Extended (& essential) DNA targets Extended (& essential) RNA targets Sarcoma Initial estimates based on working model Technology Number of Indications WGS 3-30 WES 0 Large panel Small panel Single gene sequencing 1-25 Targeted mutation testing STR testing 2 MLPA or equivalent 0 Microarray 0-3 Common aneuploidy testing 0 Karyotype 0-20 FISH 0-60 DNA repair defect testing 0-3 Methylation testing 0-3 UPD testing 0 X-inactivation testing 0 Identity testing 0 DNA extraction TBD

25 Non- WGS samples - GLH responsibilities National Quality Standards & External QC inclusive of cancer (eg QC & ISO15189 & UKNEQAS ) Turnaround Times Coordination & referral pathways & approvals inclusive of consent/assent Blood tumour & other samples (non-wgs) Transportation Identification & sample tracking Storage Bioinformatics & interpretation to national guidelines Handling & processing inclusive of cancer to national standards GLH will coordinate across its geography, ensuring all sampling handling is performed to the specified national standards.

26 WGS samples - GLH responsibilities (1/2) TO NOTE further information will be provided. DNA extraction laboratory will need be approved following satisfactory performance in the appropriate NHS England sponsored UK NEQAS DNA extraction schemes. Approval will be an ongoing process following successful participation in the ongoing UK NEQAS schemes. The GLH will perform the approvals gatekeeping and co-ordinating function for all WGS for the population that will defined by the National Genomic Test Directory including for any fast track and urgent samples. The GLH will extract DNA from blood or fresh frozen tumour tissue ( in some circumstances for formalin-fixed paraffin-embedded tissue and other samples ) in accordance with the requirements in relation to: Volume measured in µl dsdna Concentration measured by picogreen in ng DNA purity measured by Absorbance ration 260/280nm DNA yield (calculated from volume and conc) in µg DNA Integrity measured by Tapestation (Genomic DNA screentape) GLHs will perform germline genotyping prior to submission of the sample to the WGS provider. GLH will coordinate across its geography, ensuring all sampling handling is performed to the specified standards.

27 WGS samples - GLH responsibilities (2/2) GLHs will provide the extracted DNA samples in plate-format in line with nationally provided guidance and will be responsible for any failures that occur within their processing and submission arrangements to the WGS provider. NHS England will contract for the sample transport from the GLH defined single collection point to the WGS provider. The submission requirements for the WGS provider will be set out in guidance. The GLH will ensure that the labelling of all DNA samples use unique identifiers and are linked to the NHS number and are GS1 bar code compliant in line with the National Information Board/Paperless 2020 strategy. Further guidance will be issued relating to the labelling of DNA samples for submission to the WGS provider. The GLH will meet the turnaround times set by NHS England Genomics Unit for the submission of samples and for the local validation and further clinical interpretation of WGS results in line with nationally defined standards. The GLH will have Standard Operating Procedures in place for the receipt of WGS results from the Genomics England Clinical Interpretation Pipeline and for the issue of any results to Genomic MDTs in place across the GLH network, for any subsequent testing required and for the issue of reports.

28 Annotation & Validation GLHs will have the capacity and capability to undertake annotation and interpretation for all types of variants and include the handling and interrogation of WGS data. Will need to demonstrate integration with the Clinical Interpretation Partner. Will comply with appropriate validation of results, adhering to national guidance. Will regularly review the validation & reporting system, updating as evidence & guidance evolves. Will provide information on turnaround times and performance around validation and impact on the lab service.

29 New model of genomic testing Clinician requesting test Review /approve referral Sample Referral for testing Genomics laboratory hub Specialist laboratory WGS provider Extract DNA and QC SNP genotyping (for WGS) Submit diagnostic data DNA sample export Specialist gene panel test (eg. cardiac, cancer, familial hypercholesterolaemia, diabetes) Local wet lab tests (eg. cystic fibrosis mutations, arraycgh, local specialist gene panels, family member tests) Whole genome sequencing Data flow NHS data warehouse and reports portal Data flow Variant interpretation and reporting (includes MDT) Variant interpretation and reporting (includes MDT) Expert input from international clinical genomic community

30 Informatics infrastructure and interoperability A national approach will underpin development of the information requirements for genomic testing by the NHS GLH. The environment will be developed in a partnership between Genomics England and NHS England and provide an informatics solution for genomic tests including data storage solution for genomic test results and associated clinical data carried out in the NHS in England. The system will allow consented and de-identified data to flow into the UK Genomic Knowledge Base. GLHs will comply with the informatics approach set out and will have an operational plan for implementing the informatics infrastructure and management support to enable effective governance, security, quality, data sharing, accreditation, upgrading of hardware and software, staff training and incident management. GLHs will be expected to have a clear informatics and data roadmap and transition plan which will be put into place once contract award has been made. The roadmap will include plans to: enable the provided system to pull clinical data from EHRs in requesting entities across their geography enable the ordering of genomic tests from within the established local ordering systems

31 Informatics future data flow

32 National Genomic Information System Requesting & authorising platform Interface with local ordering & EHRs Approach to detailing pedigree MDT portal NGIS Capturing consent/ assent Genomic data storage infrastructure Sample tracking Clinical Interpretation pipeline, including visualisation

33 GLH informatics requirements GLHs will be supported with the task of connecting their LIMS with the NGIS for the purpose of information exchange and sample Tracking. A standards-based technical solution using HL7-FHIR or similar will be provided. The GLH will be required to: support the electronic acquisition and transmission of test requests through the NGIS across their geographies by all Ordering Entities use electronic sample tracking across their geography, using a GS1 compliant system. This will require a local interface between the NGIS and the LIMS of all organisations ordering tests. configure their LIMS to interface with the NGIS using the solution provided so that validated results can be returned to the LIMS of Ordering entities inter-operate with the NGIS to ensure unity of the care record configure LIMS so that they can communicate with the NGIS validated genomic reports in a nationally mandated format including meta-data. work with organisations across their geography to develop electronic interfaces to connect with NGIS to enable the web-based interface access to the complete genomic and clinical record for an individual.

34 Informatics key requirements GLHs should: Implement, develop and maintain a range of systems and interfaces including with: other NHS organisations across the geography, organisations in national network of genomic laboratories national infrastructure developed & provided by Genomics England. Systems must be able to: Receive orders and any externally generated results Create reports for MDT purposes. Track samples throughout the sample and diagnostic pathway. Collate & analyse data from various sources and in various formats. Provide collaboration tools and exchange appropriate information with other organisations and patients in a secure &reliable manner.

35 Overall capabilities Interface with national infrastructure (Genomics England) to access WGS inc test platform, clinical interpretation & data storage Provide clinical interpretation to enable reporting to clinicians in genomic MDTs for rare, inherited & acquired disease Including cancer Receive and process a wide range of sample types GLH capabilities Have analytical tools and resources to deliver bioinformatics, annotation and validation Perform a defined and evolving list of genomic tests and work with other GLHs to provide a national testing service Effective informatics capability and links

36 Promoting research and innovation The GLH will: Lead the development of new diagnostic methodologies and technologies Validate new genomic tests and technologies being considered for NHS implementation in line with the National Genomic Test Strategy. Have significant research expertise including collaboration, and partnerships in the field of translational genomics and active involvement in clinical trials. Be able to demonstrate translation of research into clinical practice, working with research and clinical staff to achieve this. The GLH will focus on the interface between translational research and service innovation in genomics. Co-operate, collaborate and work in a network across the entire system in England, with other countries in the UK, with GeCIP and AHSNs to ensure efficient and effective and up to date genomic testing services are delivered Establish the necessary process to support ongoing research and development at both at national and international level and collaboration with industry including alignment with other current or planned genomics activity in the NIHR infrastructure and other relevant data initiatives. Be expected to take part in future genomics projects agreed by NHS England and Genomics England. Separate contractual arrangements will be put in place for additional genomics projects. Work together with NHS England and Genomics England, to agree protocols for the identification and management of existing and potential Intellectual Property Rights.

37 Next steps

38 Next steps Draft specification released September 2017 for comment and feedback Stakeholders will have two weeks to provide comments on the specification information about how to provide comments will be outlined when the specification is released Further market engagement day on 24 October 2017 Bilateral meetings for potential bidders in November 2017 Formal procurement launched end of November 2017

39 Key related issues

40 Building Non-invasive Prenatal Testing capacity for the NHS This procurement will also include the commissioning of Non Invasive Prenatal Testing for Trisomy 21, 18 and 13 Separate initial funding for three years until agreement to include in section 7a budget (Public Health Transition/Commissioning Team) Expect to commission two GLHs to deliver this The specification will be a separate lot within the procurement but will be included in the final contract Service requirements still being developed and detail will be provided in due course

41 NHS Genomic Medicine Service The intention is for this to be inclusive of clinical genetics services to ensure seamless service delivery and integration with the genomic laboratory hubs Exact detail and relationship to current NHS GMC contracts being explored Consent model evolving and will be shared when agreed for comment There will be a clear link to personalised medicine and medicines optimisation Further details at next market engagement day

42 Questions

43 Contracting models update DRAFT may be subject to change Bonella Ramsay Partner and Co-chair, Global Life Sciences Sector DLA Piper September 2017

44 Lead Supplier Model Benefits to NHS E: NHS England Lead supplier will be accountable to NHS E & enforcement of obligations against one party only; better risk profile Sub contractor Lead Supplier Sub contractor Sub contractor Flowdown of key terms Right for NHS E to contract directly (eg novation) Streamlined contract management and resource burden for NHS E : do not need to add any costs to the bids when evaluating For the Hub, risk flow is straightforward (vertical only) Contract/programme governance can allow other suppliers in the chain to have a prominent role to engage with NHS England (eg place on boards/steering committees; lead on certain elements for the Hub) Insert date with Firm Tools > Change Presentation 44

45 "Partnering" Model Each 'joint lead supplier' is accountable to NHS E via joint and several liability in the contracts. Joint Lead Supplier Sub contractor NHS England Joint & several liability Joint Lead Supplier Sub contractor Joint Lead Supplier Sub contractor Collaboration / partnering terms Flowdown of key terms Right for NHS E to contract directly (eg novation) Must be underpinned by an agreement between lead suppliers. This allows for clear separation of roles to be agreed between lead suppliers, but joint & several liability is key for NHS E's risk profile Allows more than one supplier to have a lead role although potential for additional contract management and resource burden for NHS E Preferred model for NHS E is that financial transactions (invoicing and payment) is through one of the lead suppliers. Subcontractors can be engaged by 1 or all lead suppliers: highly fragmented supply chain likely to be viewed as higher risk in evaluation Risk that this model will not meet optimum parameters for subcontracting test thresholds Via contract/programme governance other suppliers in the chain can be given a more prominent role to engage with NHS E (eg place on boards/steering committees; lead on certain elements for the Hub) Insert date with Firm Tools > Change Presentation 45

46 New Entity / Special Purpose Vehicle NHS England Broadly 2 types of SPV: Assets and resource transferred in, able to perform services but still uses subcontractors (Type 1); or remain as a 'shell' with all services performed by subcontractors (Type 2) Suppliers may be able to demonstrate that the SPV provides efficiencies via consolidation & transparency and certainty for NHS E with regards to roles and responsibilities. Less likely with Type 2 Sub contractor SPV Sub contractor Sub contractor Flowdown of key terms Right for NHS E to contract directly (eg novation) For suppliers allocation of risk is typically more complex : horizontal and vertical. Subcontractors could be engaged (always in Type 2): highly fragmented supply chain likely to be viewed as higher risk and higher cost in evaluation. Less likely to meet optimum parameters for subcontracting test thresholds (can though show no adverse impact on quality, better value for money) VAT implication which is additional non-recoverable cost to NHS E: will be added to the bid cost in financial evaluation. Sub contractor Sub contractor Vires : Trusts need to have power to set up entities & able to provide guarantees Insert date with Firm Tools > Change Presentation 46

47 Finance, Funding Flows and Payment Model DRAFT may be subject to change Justine Stalker-Booth National Head of Financial Management NHS England Specialised Commissioning September 2017

48 The Current Arrangements (Genetic Laboratories) Funding Flows: (Generally) Rare Diseases directly or indirectly (send aways) funded via NHS England and Cancer indirectly funded via provider to provider billing Current Contract Arrangements: Rare Diseases - mix of block contracts, cost and volume and cost per test Cancer - in tariff Activity Reporting to Commissioners: No link between activity and finance High level (or non-existent) for Rare Diseases Non-existent for Cancer

49 The Financial Challenge To identify all the funding flows in order to create a budget for commissioning the Genomic Laboratory Service How much has NHS England paid directly to providers of Genetic Laboratory Services? How much has NHS England paid indirectly to providers of Genetic Laboratory Services? Must be agreed by both providers and specialised commissioning hubs Have CCGs paid for any Genetic Laboratory Services? What are the current provider to provider billing arrangements for Cancer? Joint review of the activity data collection

50 The Opportunity This a National Service so we should be developing a contracting model with a consistent methodology of counting, coding and payment which: Is as simple as possible Is fair Clearly defines what is in scope and what is not Provides clarity around funding flows and payment responsibility Links finance to activity Automates activity reporting Reduces provider to provider billing as far as possible Accommodates future revisions of commissioned tests Is underpinned by the Test Directory

51 Our Current Thinking A contracting model based on 3 elements: Part A a fixed base payment to cover the management of samples from referrers within the Lot geography (catchment area), including DNA extraction, education and liaison with clinicians Part B a payment per test undertaken based on the 18 weighted categories mapped from the Test Directory Part C a payment per report based on the 18 weighted categories mapped from the Test Directory The Test Directory will list which Tests and Reports are directly chargeable to NHS England (Rare Diseases) and which are funded via provider to provider charging (Cancer) All Tests included in the Directory, including Cancer, will be reported via the National Informatics Solution

52 Cancer All tests included in the Directory are part of the contracting model, only the funding route is different. Requests for cancer tests will operate in the same way as for rare diseases i.e. referral only via one of the 7 Lots based on a defined catchment area The Part A fixed base payment covers both Rare Diseases and Cancer and is paid directly to the 7 Lots by NHS England Part B and C payments for Rare Diseases are charged directly by the 7 Lots to NHS England Part B and C payments for Cancer are charged by the 7 Lots to the referring organisation (remains in-tariff )

53 Cancer continued.. Our proposed approach to Cancer: Avoids the necessity of unpicking cancer funding from tariff (a complex and time consuming exercise for providers) Mitigates the risk to both NHS England and the 7 Lots of not identifying all the funding Provides a clear governance structure for payment Provides referring organisations with a price list of tests with clear definition of payment responsibility Reduces the risk to the 7 Lots of non-payment by referring organisations Identifies the activity and cost of cancer tests meaning that it would be possible to unpick from tariff in the future if required

54 Next Steps Agree the Lot boundaries (catchment area) A template mapping every Trust in England to each Lot will be shared for comment this will include county and STP footprint Track the current payments made by NHS England either directly or indirectly for 2016/17 A simple template will be provided to the Lot leads To be completed by each of the current incumbent providers (c23 in total) Review the current activity to help inform the Lot activity baselines Pre-populated templates based on the activity data collection will be provided to each of the 7 Lots for validation and to identify any significant gaps Opportunity for finance leads to discuss contracting and finance on 28 th September 10.30am to 1.30pm

55 Questions