NHS England s response to the public consultation: Supporting Research in the NHS: A consultation covering changes to simplify arrangements for

Transcription

1 NHS England s response to the public consultation: Supporting Research in the NHS: A consultation covering changes to simplify arrangements for research in the NHS and associated changes to the terms of the NHS Standard Contract

2 NHS England INFORMATION READER BOX Directorate Medical Operations and Information Specialised Commissioning Nursing Trans. & Corp. Ops. Strategy & Innovation Finance Publications Gateway Reference: Document Purpose Consultations Document Name Author Publication Date Target Audience NHS England s response to the public consultation: Supporting Research in the NHS: A consultation covering changes to simplify arrangements for research in the NHS and associated changes to the terms of the NHS Standard Contract NHS England 4/05/2018 CCG Clinical Leaders, CCG Accountable Officers, CSU Managing Directors, Care Trust CEs, Foundation Trust CEs, NHS England Regional Directors, Directors of Finance, GPs, NHS Trust CEs, Researchers, Research funders, Research sponsors, Industry Stakeholders in clinical trials Additional Circulation List Description #VALUE! In November 2017 NHS England launched a consultation Supporting Research in the NHS: A consultation covering changes to simplify arrangements for research in the NHS and associated changes to the terms of the NHS Standard Contract. This document provides a summary of the responses received to our proposals, including key themes identified in the consultation responses, our response to these findings and our next steps. Cross Reference Superseded Docs (if applicable) Action Required Timing / Deadlines (if applicable) Contact Details for further information Guidance on Excess Treatment Costs, NHS England, 2015 N/A N/A N/A 0 Innovation and Research Unit 4N04, Quarry House Leeds LS2 7UE 0 Document Status england.research@nhs.net This is a controlled document. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. Any printed copies of this document are not controlled. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet. 2

3 Document Title: NHS England s response to the public consultation: Supporting Research in the NHS: A consultation covering changes to simplify arrangements for research in the NHS and associated changes to the terms of the NHS Standard Contract Version number: 1.0 First published: 04 May 2018 Prepared by: Strategy and Innovation Directorate Classification: OFFICIAL This information can be made available in alternative formats, such as easy read or large print, and may be available in alternative languages, upon request. Please contact england.research@nhs.net Promoting equality and addressing health inequalities are at the heart of NHS England s values. Throughout the development of the policies and processes cited in this document, we have: Given due regard to the need to eliminate discrimination, harassment and victimisation, to advance equality of opportunity, and to foster good relations between people who share a relevant protected characteristic (as cited under the Equality Act 2010) and those who do not share it; Given regard to the need to reduce inequalities between patients in access to, and outcomes from, healthcare services and in securing that services are provided in an integrated way where this might reduce health inequalities. 3

4 Contents Contents 4 1. Background 6 2 Engagement and Consultation 6 3 Managing Excess Treatment Costs in Non-Commercial Research 7 4 Managing Excess Treatment Costs Consultation Responses Agreement to the six design principles we used to develop our proposals Partnering with the 15 NIHR Local Clinical Research Networks (LCRNs) to help manage the ETC process on behalf of their local CCGs Coordination of ETCs by LCRNs at sub regional level Pooling risk across the 15 LCRNs to manage annual variation in ETCs Application of proposals to multi-site trials Establishing a more rapid, standardised process for specialised commissioning ETCs, which are the responsibility of NHS England Strengthening the process for specialised services ETCs that fall below the proposed minimum threshold would not be considered by NHS England Additional comments in response to the proposals for specialised services Setting a minimum threshold under which ETCs will need to be absorbed by providers participating in studies and a maximum threshold over which cases will be challenged early in the process Setting a minimum threshold under which ETCs will need to be absorbed by providers participating in studies Suggestions for other ways to set thresholds that would work better than those presented in the consultation Setting a maximum threshold for ETCs, over which cases will be challenged early in the research funding process Implementation of a nominal payment cap for primary care to discourage applications for ETCs where the cost of processing will significantly outweigh the cost of the ETCs Additional comments on our proposals Subvention Funding 19 5 Proposed Way Forward Managing Excess Treatment Costs Further design work to be undertaken between May and October What will be implemented by October 2018? Further design work to be undertaken between October 2018 and April What will be implemented by April 2019? 21 4

5 6 Further Improving Commercial Contract Research Set Up and Reporting 22 7 Commercial Contract Research Set up and Reporting Consultation Responses Costing NHS provider participation in commercial research Publishing a common, simple set of performance data on research initiation and delivery Sponsor/representative actions 27 8 Proposed Way Forward Commercial Contract Research Set up and Reporting Charging for NHS provider participation in commercial research Publishing a common, simple set of performance data on research initiation and delivery Sponsor / representative actions 34 9 Proposed National Variation to the NHS Standard Contract NHS Standard Contract Consultation Responses Proposed Way Forward NHS Standard Contract 36 Annex A1: ETC Consultation respondent groups, organisations and response rates 38 Annex A2: ETC Consultation responses to each question by organisation/group 40 Annex B2: Further Improving Commercial Contract Research Set Up and Reporting Responses to each question 49 Annex C: Final wording to be included in the National Variation to the Contract 53 5

6 1. Background In November 2017, NHS England and the National Institute for Health Research (NIHR) set out a joint statement identifying how we will work together to support and apply research in the NHS. At the same time NHS England, the Department of Health and Social Care (DHSC), NIHR and the Health Research Authority (HRA) launched a consultation Supporting Research in the NHS: A consultation covering changes to simplify arrangements for research in the NHS and associated changes to the terms of the NHS Standard Contract. We invited comments on proposals developed by all partners to manage excess treatment costs (ETCs) better, and further improve commercial contract research set-up and reporting. NHS research can result in excess treatment costs. These are costs that arise as a result of the difference between the cost of standard treatment and the cost of treatment within a research study in non-commercial research projects. NHS England and NIHR have heard continued frustration about the complexity and variation in processes for commissioners and providers agreeing these costs. Sponsors of commercial contract research still face frequent uncertainties and delays in site set-up. We consulted on new arrangements to standardise processes to introduce greater certainty and reduce administrative costs for both NHS providers and commercial sponsors. This document provides a summary of the responses received to our proposals, including key themes identified in the consultation responses, our response to these findings and our next steps agreed with our partners, DHSC, NIHR, HRA, NHS Improvement (NHS I) and NHS Clinical Commissioners (NHSCC). The consultation also set out specific proposals for changes to the terms of the National Standard Contract to support implementation of the proposed new arrangements. Section 9 addresses this aspect of the consultation. 2 Engagement and Consultation The consultation was launched on the 30 November 2017 and closed on 2 February Engagement was promoted in the following ways: Announcement at the NHS England public board meeting on 30 November News item on NHS England website linking to the consultation hub. Announcement at the Economist War on Cancer event on 21 November Notices in the CCG bulletin. Notice in NHS Providers bulletin. Promotion via all partner organisations NHS England, DHSC, NIHR, HRA NHS I and NHSCC. to key stakeholders/groups informing them about the consultation launch with a link to the NHS England Consultation Hub. 6

7 During the consultation period we also held listening events in London (10 January 2018) and Leeds (15 January 2018) where interested organisations and individuals were invited to discuss the consultation questions. A further engagement workshop was held at the DHSC Non-Commercial Costing and Attribution Group meeting on 11 January 2018 to discuss proposals for ETCs. Details of consultation respondent groups, organisations and response rates are outlined for managing ETCs in Annex A1 and for commercial contract research set up and reporting in Annex B1. 3 Managing Excess Treatment Costs in Non-Commercial Research In our consultation, we noted that despite a number of attempts to clarify and improve the process for managing ETCs, including the 2015 NHS England Guidance on Excess Treatment Costs, ETCs continue to be a cause of friction between researchers, commissioners and providers and remain one of a number of barriers to timely execution of research in the NHS. We proposed three changes to overcome some of the longstanding issues with ETCs (Figure 1): 1. Partnering with the 15 NIHR Local Clinical Research Networks (LCRNs) to help manage the ETC process on behalf of their local Clinical Commissioning Groups (CCGs). 2. Establishing a more rapid, standardised process for ETCs associated with specialised commissioning, which are the responsibility of NHS England. 3. Setting a minimum threshold under which ETCs will need to be absorbed by providers participating in studies. These proposals were developed based on the following design principles: (i) Capability: It is unrealistic to expect 200-plus individual CCGs all to have the expertise to navigate the complexity of ETCs equally well. Instead we should better utilise existing sub regional expertise. (ii) Consistency: The whole country should follow the same process. (iii) Cost neutrality: Compared with the current position, any solution cannot afford to create an additional unfunded NHS cost pressure. Nor should it seek to reduce existing commissioner expenditure. In this we are hindered by poor existing data collection. Our best estimate of the total national cost to commissioners of ETCs is in excess of 7m, but not more than 30m, per annum. 7

8 (iv) Simplicity: We are moving towards creating accountable care systems in the NHS, with reduced transaction costs between commissioners and providers. In this context, the friction over what can sometimes be very small amounts of money looks increasingly anomalous. (v) Single point of access: It should be clear who to approach for help or to manage applications. (vi) Transparency: Researchers and providers tell us that decisions are made behind closed doors, with criteria for decision-making not made available. In future decisions should be open and transparent to all stakeholders. Our vision for managing ETCs From the feedback in the consultation responses we can now describe our vision for a system to manage ETCs better. We are now finalising the detail of how this will be achieved and delivered and this could further refined but the description below gives an overview of the elements of the new streamlined process. Figure 1: Key elements of the new process for ETCs Costing stage Complete costings using a standard costing methodology High cost ETCs identified and put to an assessment panel at funding stage Costings reviewed and ETC per patient cost agreed Recruitment stage Costings entered onto the Clinical Research Network (CRN) Central Portfolio Management System (CPMS) Researchers obtain HRA approval for the study Recruitment sites brought on board and recruitment commences Recruitment information entered into the CPMS Payment stage CRN uses data on CPMS to calculate ETCs incurred by provider organisation When the minimum threshold for that provider is exceeded, payment is made by CRN 8

9 4 Managing Excess Treatment Costs Consultation Responses 237 individuals and organisations responded to some or all of the online ETC consultation. 59 individuals attended our listening events in London and Leeds. 21 individuals shared their views at a workshop at a DHSC Non-Commercial Costing and Attribution Group meeting. Annex A2 summarises the response to each of our consultation questions by responder group. 4.1 Agreement to the six design principles we used to develop our proposals 94% of responders agreed with the six design principles, often amplifying their agreement in comments: The design principles encapsulate all the current problems with ETCs (University Hospital Acute Trust); They are brilliant who cannot agree/like them? (Academia) Yes. It is important that the process is simple, transparent, and consistent across the country and organisations. The current inequality and confusion is a significant barrier to implementing interventional research across the NHS. (Mental Health Trust) Some responders had specific comments on individual principles: Capability: Some responders suggested that LCRNs may require additional support in the implementation of these proposals. On the whole we welcome these principles, although their implementation by LCRNs will require support and additional capability (Research member organisation) Consistency: Many responders agreed with this principle, emphasising that consistency of decision making is as important as the process. Consistency is key - local, regional and national variation on ETC's is substantial, a consistent national approach is key to developing an ETC funding process and enabling access to research (Acute Trust R&D department). The principles seem reasonable as long as there is equity across the system and the same and consistent methodologies are applied to all commissioners and providers. (Acute Trust R&D department) Cost neutrality: Many responders agreed with the sentiments of cost neutrality. cost neutrality should not perhaps be the principle used for ETC funding decisions although it is a clear consideration in design of the system itself. (Research member organisation). However, it was suggested that the wider economic impact of research studies should also be taken into account in this principle; a number of stakeholders highlighted that studies with ETCs often deliver significant savings in the long term, whilst some studies also generate excess treatment savings. 9

10 Simplicity: Agree that ETC discussions often focus on small amounts of money, however the discussions can be long and fractious, and therefore a simplified system would be welcome. (Acute Trust R&D department) Single Point of access: A clear single point of access for managing applications would cause less confusion and make the process more streamlined. (Acute Trust R&D department) Transparency:...decisions should be open and transparent and accessible to the researchers. (Acute Trust R&D department) 4.2 Partnering with the 15 NIHR Local Clinical Research Networks (LCRNs) to help manage the ETC process on behalf of their local CCGs The responses to the questions we asked on this proposal are summarised below Coordination of ETCs by LCRNs at sub regional level 85% of responders agreed with the proposal that ETCs will be better coordinated by LCRNs at sub regional level with a single point of contact rather than managed by CCGs individually. Example responses include: This makes sense as the expertise and resource is located here. (Research support organisation) We have experienced huge variation in practice in the way that CCGs handle ETCs, so this is extremely welcome. (Academia) This has been a regular point of friction between commissioners and providers for a long time now, which has been exacerbated by the variable approaches of different CCGs - providing a single point of contact would massively simplify things for providers. (Private consulting company) Key additional themes emerging from the consultation response included the need for: National oversight, particularly for national multi-site studies. Additional training and capacity within LCRNs to undertake these roles. A transparent and consistent process between LCRNs and a stronger working relationship between LCRNs and CCGs. Process that will be implemented: Based on the consultation response, the following process will be put in place by 1 October 2018: NIHR CRN National Coordinating Centre (CRN CC) will establish a standard process across England to manage ETCs, incorporating a single point of contact in each LCRN, for services commissioned by CCGs and Specialised Commissioning. This will include: o Establishing a clear oversight role for the Lead LCRN to coordinate ETCs for multi-site trials in England. 10

11 o A consistent approach across all LCRN regions in conjunction with partner organisations such as research funders and the HRA. o Working with the NHS R&D forum to build on the existing AcoRD Specialist capabilities already embedded in the CRN study support service available for researchers. CRN CC will have national operational oversight of the ETC management system, using data visualisation for ongoing monitoring of spend and commitment. We will explore the operational requirements for studies involving sites in the devolved administrations. The Lead LCRN will retain responsibility of coordination on behalf of any English sites, regardless of whether the study is taking place in other devolved administrations Pooling risk across the 15 LCRNs to manage annual variation in ETCs 77% of respondents agreed that it would be sensible to pool risk across the 15 LCRNs. Key additional themes emerging from the consultation response included the need for: Processes to encourage equity of access to research. Respondents primary concern was that funds would be accessed disproportionately by highly research active organisations. As a result, some CCGs may contribute to ETCs but the benefits to patients may not be realised proportionately in their health economy. A fair and transparent process for determining CCG ETC budgets and management of unspent funds. National oversight of variation between CCGs and LCRNs. Process that will be implemented: There will be a defined allocation from each CCG that will contribute to the regional funding pool for payment of ETCs. Allocation of 5.2p per capita per CCG per annum to ETCs will be undertaken for a 6-month trial period from 1 October 2018 to 31 March 2019 (equating to an actual allocation of 2.6p per capita for the 6-month trial period). This level of allocation was determined based on the average allocation per capita of the 33 CCGs that currently undertake fund pooling for ETCs, in agreement with NHSCC and CRN CC. Data on actual ETCs incurred during this period will inform a review of the allocation rate for 2019/20. NHS England will continue to work with NHSCC and CRN CC to ensure any adjustments, if necessary, are reflected in 19/20 planning assumptions. NHSCC and CRN CC will lead on work between May and October 2018 to establish mechanisms: The details of future working relationships between CCGs, CRN CC and LCRNs. Managing ETC regional pools to minimise bureaucracy, regional variation, financial risk and ensure equity of access for CCG populations. 11

12 We understand there to be a number of potential options in respect of the mechanism for achieving this proposal, including the working relationship between the various parties. These are currently under consideration and further details will be published in due course Application of proposals to multi-site trials 77% of participants agreed that the proposal of partnering with 15 NIHR LCRNs to help manage the ETC process on behalf of their local CCGs would work for both single and multi-site studies. Suggestions for implementation proposed by consultation respondents included: A single lead LCRN for multi-site trials (potentially based on the lead study site for the trial), including for trials that are active in devolved nations. A process to identify and manage potential differences in ETCs between LCRN regions. To be mindful of potential conflict of interest for LCRNs regarding the need to drive up recruitment vs. manage ETCs. Process that will be implemented: As described above, CRN CC will establish a clear oversight role for the Lead LCRN to coordinate ETCs for multi-site trials in England and explore the operational requirements for studies involving sites in the devolved administrations. The Lead LCRN will retain responsibility of coordination on behalf of any English sites, regardless of whether the study is taking place in other devolved administrations. CRN CC will lead on defining and implementing nationwide standard operating procedures utilising the suggestions from this consultation. 4.3 Establishing a more rapid, standardised process for specialised commissioning ETCs, which are the responsibility of NHS England The responses to the questions we asked on this proposal are summarised below Strengthening the process for specialised services 88% of respondents agreed with the proposal to strengthen the process for specialised services. The following considerations were key themes in the responses we received: A system with one point of contact and one system for all commissioners was the preference of some responders. The need for a process that accommodated complex pathways such as those where commissioning responsibilities may be shared between NHS England and CCGs, or situations where costs may fall in one part of the system and savings are realised in another. Decisions regarding high cost ETCs to be made at grant funding stage to prevent studies being delayed, this needs to include early engagement with funders. 12

13 Process that will be implemented: We will establish a more rapid standardised process for specialised commissioning ETCs. NHS England Specialised Commissioning directorate will now progress the detailed planning and implementation taking into account feedback from the consultation. In response to the feedback received through the consultation we will utilise a single point of contact at the LCRN for all ETCs irrespective of the commissioner (CCG or specialised commissioning). Studies will be triaged by the CRN as to the correct process and those for specialised commissioning will enter the new standardised process. Specialised Commissioning Directorate will work closely with CRN CC and LCRNs to ensure as much alignment of processes across the whole model as possible. Specialised Commissioning will conduct a data collection exercise in conjunction with NIHR CRN to gain a more detailed understanding of the quantum of ETCs associated with specialised services. Building on the successful national cost attribution pilot for the NIHR Efficacy and Mechanism Evaluation (EME) programme we are already establishing an ETC assurance process with all NIHR funding programmes. Linking with the collective ETC management process, Specialised Commissioning will be developing a new process to be as unified with the new ETC management process. We will engage with all stakeholders including representatives from charitable research organisations and other non-commercial funders as this develops. Our intention is to publish our planned specialised commissioning process by end of June 2018 which we will test with stakeholders ETCs that fall below the proposed minimum threshold would not be considered by NHS England. 73% of respondents agreed that ETCs that fall below the minimum threshold should not be considered by NHS England for ETCs in specialised commissioned services. However, the comments also covered operation of a minimum threshold for ETCs within non specialised services. Comments centred on the following key themes: Operation of a minimum threshold - responders expressed a preference for consistency for processing ETCs, irrespective of whether the services are commissioned by NHS England or CCGs. If this is not possible there needs to be good coordination between the two systems. Some responders commented that the thresholds needed to be reasonably low and affordable to all stakeholders. To mitigate the risk of thresholds becoming a financial burden on research, some responders suggested a cap on the amount providers should absorb (irrespective of which threshold setting option is selected). If a variable threshold was to be applied, then in accordance with the simplicity principle, this should be easy to understand and operate across England. Some concern was raised about the accountability and compliance with subsequent guidance. The variability and complexity could be reduced to a manageable level by setting a small number of Trust income bands with associated levels of ETC 13

14 absorption (Say 5 bands Max?) These bands could be adjusted based on a review of the 1st year of operation. (Research manager). Considerations in calculating the threshold - responders suggested that the threshold should only apply in relation to ETCs that are demonstrably outwith tariff and net of excess treatment savings. Potential barrier to research - this concern related to pilot or smaller studies where ETCs would fall below the minimum threshold (should the threshold be set on a per study basis). A few comments raised an important point that decisions to fund research projects should not be driven by the likelihood of ETC recovery, but should consider the quality of the research. The threshold doesn t address the question of the quality of research and there is a real danger that the primary driver for a Trust will be meeting metrics on performance which bear little relationship to clinical and societal value. (Academia) Unintended consequences - a number of responders were mindful that thresholds could drive unintended behaviour by providers and sponsors. It was suggested that providers could artificially inflate costings to ensure that ETCs reach the minimum threshold. Similarly, sponsors may also be encouraged to reduce programmes of trials and present them as individual projects to remain under the threshold (should the threshold be set on a per study basis). Our plans for implementation of a minimum threshold for ETCs for both specialised and non-specialised commissioned services are outlined in section Additional comments in response to the proposals for specialised services For this question many responders took the opportunity to echo the sentiments raised in other areas of the consultation. These are summarised below: National system - some responders re-iterated that a national model possibly based of a central fund would be better than any of the options that were presented. Whilst others suggested that it would be simpler to have ETCs incorporated into research costs as part of the funder s overall grant. To streamline processes, there were suggestions to have ETCs calculated centrally rather than by individual providers. Assessment panels - the process would be better if ETCs were assessed and agreed at the grant funding stage. There was some concern raised that any panels considering ETC applications should be diverse enough to include a variety of stakeholders, including charities. Threshold setting - a few responders reiterated a preference to cap the amount of ETCs absorbed to prevent research active providers from being penalised. Excess Treatment Savings should also be taken into consideration 14

15 in setting thresholds. Stakeholders stated that the process needs to be mindful of the wider research infrastructure, including devolved administrations, and the increase in research which crosses boundaries into public health and social care, where the commissioner may not be the NHS. The need to recognise complex pathways where commissioning responsibilities may overlap was raised again. Some responders felt that no thresholds should be in operation and all ETCs should be paid by the commissioner. Implementing the new system - some comments reflected that these were significant changes being proposed to the system. As such, there should be careful planning or appropriate monitoring before changes were implemented. Our response to these comments are summarised in the implementations plans outlined in the relevant parts of section 4 above and below. 4.4 Setting a minimum threshold under which ETCs will need to be absorbed by providers participating in studies and a maximum threshold over which cases will be challenged early in the process NHS treatment costs are funded by the NHS through normal commissioning arrangements for patient care. Where national prices exist ETCs only apply where it can be clearly demonstrated that the study leads to costs in excess of the treatment costs covered by that price, as outlined in current NHS England guidance. Where the services are priced locally, providers and commissioners must follow the local pricing principles and rules where agreeing a price. For the new models of ETC payment we have proposed, we continue to expect that requests for ETCs will take account of the tariff, and for tariff based services, costs will only be reimbursed where it can be demonstrated that treatment costs incurred in the research study are in excess of a reasonable level of treatment costs covered by tariff or other contractual arrangements. This determination of which treatment costs of research are covered by tariff (where a tariff is in place for the service) or other contractual arrangements, and which costs are excess treatment costs eligible under this policy will be made by NIHR CRN in conjunction with NHS England s pricing team. The principles of Excess Treatment Savings will also be taken into account in these discussions. Therefore, when we refer in the following sections of the document to setting a threshold for ETCs, we mean ETCs that are demonstrably outwith tariff Setting a minimum threshold under which ETCs will need to be absorbed by providers participating in studies We asked respondents to rank the options we presented for setting a minimum threshold with their preferred option first and the least preferred last. 15

16 The options outlined in the consultation document were as follows: Option Methodology 1 ETC per patient, per financial year for a Trust. 2 Total (cumulative) ETC per Trust, per financial year, based on Trust income which would be banded to offer stability around the threshold year on year. 3 ETC per Trust, per financial year, fixed sum. 4 ETC per study per Trust (over lifetime of the study). Two methodologies were used to assess the degree of support for each option: i) Assessing the percentage of first preference ii) Assessing the options weighted by the order of preference (highest preferred = 4, least preferred = 1) to obtain an overall measure of strength of support for each option The tables below set out the results of each methodology. Most preferred Least preferred Option 1 20% 28% Option 2 27% 26% Option 3 24% 30% Option 4 29% 16% Total 100% (n=201) 100% (n=190) Preferences as a percentage of total responders. Ranked Option Weighted preference score 1 Option Option Option Option Options weighted by order of preference There was no strong consensus for any particular option. However, a threshold calculated on ETCs per study per Trust (option 4) showed a marginal preference with cumulative, income linked ETCs per Trust per year (option 2) coming a close second. Respondents who supported Option 4 (ETC per study per Trust) considered this option to be simple to understand and practical, noting similar models operating a minimum threshold in Wessex and other regions are currently working well using this method. Respondents who supported option 2 (cumulative ETC per Trust per financial year based on Trust income) considered this to be the most equitable, and least likely to disincentive providers from participating in research with low ETCs Suggestions for other ways to set thresholds that would work better than those presented in the consultation 60% of responders thought that there were no other ways to set thresholds other than those presented. Of those responders that indicated that there were other ways 16

17 to set thresholds, many (40%) didn t offer alternative methods but used the opportunity to reiterate that a national model for ETCs based on a central pot would be better than any of the options that were presented. Whilst others suggested that it would be simpler to have ETCs incorporated into research costs as part of the funder s overall grant. Process to be implemented: Following careful consideration of the comments relating to the two most preferred options we have decided to use option 2 - Total (cumulative) ETC threshold per Trust, per financial year, based on Trust income. The Trust incomes will be banded to offer stability around the threshold year on year. Therefore, for all non-commercial studies that have ETCs, Trusts will be required to absorb ETCs up to their threshold. Once the provider has absorbed their threshold for that year, they will have additional applicable ETCs funded through the new arrangements. We have made the decision to use option 2 because consultation responses told us: this was the most equitable option the alternative method based on ETCs per study per Trust could drive perverse behaviours with studies with ETCs falling below the threshold not being adopted by providers there should be a cap/maximum value for providers to absorb ETCs Partner organisations also felt that option 2 would put the least administration burden on providers. We have begun modelling the impact of using this methodology and NHS England and NHS I will work together to agree the exact value that each individual provider will need to absorb. This will be calculated in line with the design principle of overall cost neutrality nationally. Our intention through reform of ETCs is neither to increase total provider sector costs nor to increase total provider sector income. Using data obtained on current levels of absorption of ETCs for 43 Trusts, our modelling suggests that Trusts are absorbing on average 0.01% of their operating income. In our work with NHS I colleagues we will agree a banding system for Trust income to be applied to threshold calculations to offer year on year stability as per our original proposals. Further work will now be undertaken to define the operation of the minimum threshold for both non specialised and specialised commissioned services Setting a maximum threshold for ETCs, over which cases will be challenged early in the research funding process Our consultation document stated that we will also ensure early engagement in the funding process, allowing high cost/low value proposals to be challenged and potentially rejected earlier in the process. The key themes that became evident in comments on this proposal are: 17

18 Definitions - stakeholders were keen to establish the definition or criteria for high cost/low value proposals which we referred to in the consultation document under both specialised commissioning proposals and proposals for a minimum and maximum threshold. These should be defined in consultation with other relevant stakeholders and patient representatives, and should be clear and transparent. The reasons for rejecting a study should also be clearly stated. (Research charity) Decisions driven by cost alone - there was concern that any decisions on studies labelled as high cost/low value would be made purely on a cost basis. Stakeholders asked for reassurance that value would be determined by other factors including, most importantly, patient benefits. commissioners should not exclude studies entirely on the basis of financial cost. The potential for patient benefit including longer term cost savings and benefits to the wider society should be at the heart of decisions to support studies with high ETCs. (Research member organisation) Timings of decision making - the timing of any decisions relating to studies with ETCs above a maximum threshold was also a concern. Stakeholders were clear that this should not affect the timing of studies being set up. Alternatively, there was a view that researchers should not have to secure agreement to ETCs prior to research funding applications being made as this would stifle innovation. Further work to agree implementation: For individual studies, further work is now required in order to establish the value for a maximum threshold for ETCs above which there will be scrutiny of the value of the study to the NHS. NHS England and partners will continue to engage with NIHR and other funding bodies, including via the Association of Medical Research Charities, to define criteria and the mechanism by which these studies will be assessed early in the process. We have taken note of comments from stakeholders that this should be at the research funding stage and we will continue to seek views on how this can be achieved most effectively and efficiently in practice. Once this work is complete we will outline the process to be implemented Implementation of a nominal payment cap for primary care to discourage applications for ETCs where the cost of processing will significantly outweigh the cost of the ETCs 69% of respondents agreed with the proposal for a nominal payment cap in Primary Care CCG-related ETCs, so that the cost of processing would not significantly outweigh the ETC payment value. However, those that agreed with the nominal payment cap were concerned about creating a barrier to research in the primary care setting. Those that disagreed with the nominal payment cap were strongly concerned that this would create a barrier to research in the primary care setting as they felt that Primary Care organisations would not easily be able to absorb ETCs. However, they agreed that it was necessary to make processing ETCs more efficient. 18

19 primary care recruitment is already extremely challenging. Any additional barrier such as practices having to absorb ETC's, however small, would be likely to negatively impact on recruitment as practices are such small organisations and the financial incentives to participate in research are already insufficient and barely cover the time required by practice staff. (Research support organisation) Process to be implemented: We will operate new ETC model to incorporate a nominal minimum level of payments to primary care providers. This will not be a minimum threshold under which primary care organisations will need to absorb ETCs but a value for cumulative claims that would have to be reached before the claim was processed. CRN CC will lead on work to establish the value and operation of this mechanism, working with NHSCC and national representative bodies including the BMA, GPC and RCGP. 4.5 Additional comments on our proposals In addition to the responses to specific questions outlined above, stakeholders asked for clarification regarding subvention funding Subvention Funding A number of individuals and stakeholder groups asked for clarity on how the current DHSC ETC subvention fund would operate within a new ETC model for both CCG and specialised commissioned services. Will the DH subvention fund also be moved into this funding process? (Academia) If the outcome of the consultation is to establish an alternative process for ETCs, there needs to be clarification on whether the operating procedures for the subvention system will be amended. (Acute Trust R&D department) And in relation to the maximum threshold When would a subvention request be submitted? At what limit? (CCG) Process to be implemented: Consultation responses emphasised the need for a national, simplified ETC funding system with a single point of access. Under the new system outlined above, a separate subvention funding process will be unnecessary. Studies that would have been eligible for subvention funding previously will have their ETCs funded through the new system. 5 Proposed Way Forward Managing Excess Treatment Costs Taking feedback from consultation responses we will now begin a detailed planning and implementation phase until October 2018 during which time the operating model will be fully developed. All partner organisations (NHS England, DHSC, NIHR, HRA, NHS I and NHSCC) will continue to work together and engage with stakeholders as this work progresses. We will enter a transition phase from October 2018 to March 19

20 2019. A new national system for ETCs in England will be fully operational from 1 April As per our commitment in the consultation document we will embed data generation and collation within the new operational arrangements to enable a more accurate understanding of the cost of ETCs. We will monitor the impact of changes in the first year making necessary refinements to improve the system for future years and build continued evaluation into the new arrangements. 5.1 Further design work to be undertaken between May and October 2018 Activity Agree the costing methodology for ETCs for both specialised and nonspecialised commissioned services Publish planned Specialised Commissioning process Finalise exact values for provider minimum thresholds within a banding system for Trust income Design of the CRN/LCRN and Specialised Commissioning Standard operating procedures Develop joint operational guidance with our partners Define ETC exceptions that may need case-by-case consideration Develop model of transition of existing studies and existing regional management models into a new system Agree the maximum threshold for high value ETCs and work closely with stakeholder to design a mechanism to assess applications Develop and agree reporting requirements and mechanism for new models Delivered by end May 2018 June 2018 September 2018 September 2018 September 2018 September 2018 September 2018 September 2018 September What will be implemented by October 2018? Activity Trial period of operation of new ETC management model for both nonspecialised and specialised Timescales October 2018 to end of March

21 Activity commissioned services with single point of contact CCG contribution to sub-regional pools for payment of ETCs Trial of operation of the minimum threshold values for providers Trial of a nominal minimum level of payments to primary care providers within the CRN/LCRN model Prospective data collection from CRN CPMS of ETCs incurred in the new model Mechanism for monitoring and the operation of the new model Timescales October 2018 to end of March 2019 October 2018 to end of March 2019 October 2018 to end of March 2019 October 2018 onwards October 2018 onwards 5.3 Further design work to be undertaken between October 2018 and April 2019 Activity Continued refinement of the model based on stakeholder feedback, learning and monitoring mechanisms Data analysis to inform review of CCG allocations and minimum Trust thresholds for 2019/20 Refinement of reporting requirements Delivered by end Ongoing February 2019 Ongoing 5.4 What will be implemented by April 2019? Activity Operation of refined ETC management models for CCG commissioned services using agreed CCG allocations and minimum Trust thresholds for 2019/20 Operation of refined ETC management model for specialised commissioning services using agreed minimum Trust thresholds for 2019/20 Mechanism for assessing high value ETCs Mechanism for ongoing evaluation and refinement of ETC management models Continued oversight and reporting on ETC management models 21

22 6 Further Improving Commercial Contract Research Set Up and Reporting In our consultation, we noted that sponsors of commercial contract research (including clinical investigations of medical technologies) still face frequent uncertainties and delays in site set-up. Providers in England operate as individual entities, thus the cost of undertaking these research activities across providers can vary. As a result, each participating provider currently issues its own confirmation of participation, and can seek to vary contract terms and prices for exactly the same study. In some cases, this is resulting in differences of up to nine months between confirmation of the fastest and slowest sites. We suggested that it should be possible to eliminate these delays, making the NHS in England a more attractive base for research, benefiting patients, NHS providers, and the wider UK economy. We also suggested that further standardisation could introduce greater certainty and reduce administration costs for NHS providers and, industry alike. To unlock these benefits, our consultation proposed to mandate standard arrangements for charging for commercial research, for contracting and for performance reporting, via the NHS Standard Contract, to apply right across the NHS in England. Our vision for improving commercial contract research From the feedback in the consultation responses we can now describe our vision for a system to improve commercial contract research processes. Figure 2 provides a description of the key elements of a new streamlined process. Figure 2: New Commercial Contract research set-up and reporting process Costing review / Expert Assessor stage CRN CC Methodology Review: CRN to work with sponsor and provider representatives to refine the standard costing methodology The national standards for assessor and clinical expert review roles, as defined by Sponsors and provider representatives, to be defined and rolled out, including the training content for delivery through R&D Forum Testing stage CRN to work with identified stakeholders to test and optimise proposed business process though phased implementation Implementation and post-implementation stage NIHR, HRA and NHS England publish binding joint directions on commercial research studies, including on charging and contracting Continued refinement of process and methodology in practice through a feedback mechanism Formal six-monthly review presented to Industry Costing Group 22

23 We invited respondents to answer the following questions: Contract value: Which do you think is the best option for costing NHS provider participation in commercial research? (Option #1 National, binding coordination of contract values 1 ; Option #2 - First/lead site setting of contract values, with MFF adjustment; Option #3 Alternative options). If you have selected Option 3, what is your proposal and how does it meet the design criteria outlined, i.e. capability, consistency, transparency, speed and simplicity, single point of access and continuous improvement? Why do you think the option you have selected is the best one? Performance Reporting: Do you agree that we should reaffirm, through the NHS Standard Contract, the requirement for NHS providers to report and publish a standard dataset for performance in clinical research initiation and delivery? If you have answered N to the above, what are the concerns/objections we should consider? Sponsor/representative actions: Are there any additional steps that you think would be helpful on the part of commercial research sponsors and/or their representatives? 1 The nationally binding coordination of contract values is the price attributed to the additional activities above standard of care 23

24 7 Commercial Contract Research Set up and Reporting Consultation Responses 170 individuals and organisations responded to some or all of the commercial contract research section of our consultation. 54 individuals attended our listening events in London and Leeds. 7.1 Costing NHS provider participation in commercial research Of respondents who expressed a preference in relation to costing NHS provider participation in commercial research, 63% preferred Option 1 National binding coordination of contract values. We did not weight consultation responses, but instead considered responses by organisation type and research activity to ensure that the views of organisations that were disproportionately affected by the proposals (e.g. research-active Trusts) were considered. (Please see the summary tables at Annex B1 and B2). Respondents suggested it was the option that best met the six principles of speed, predictability, simplicity, consistency, fairness and credibility on which we developed our proposals: a research active Trust stated It would cut out significant local administration and so save not just time in set up but cost. ; A single coordination and pricing function hosted by NIHR is preferable as this will provide a standardised approach (a specialist Trust); A standardised, simple approach across the country will make England a more attractive base for research. (an international pharmaceutical retail outlet); Option 1 would make the costings unbiased, fair & consistent across sites, also driving Industry to work and budget the same way (an industry trade association) Respondents also suggested that Option 1 would best enable smaller Trusts with more limited resources to participate in clinical trials: A specialist Trust stated that It would just be so much easier especially for the smaller Trusts with little or no resource for costing. Key themes identified in relation to Option 1 included: Need for appropriate resourcing and preparation: Overall, the majority of those respondents who expressed a preference, welcomed the approach of trained and experienced expert assessors ( National Co-ordinators ), and thought this an area of strength for this proposal. Respondents emphasised that the new system would need to be appropriately resourced and prepared. Ensuring National Coordinators have defined minimum training/experience will be vital to the success of the proposed process (a research body representing a professional group); The option would need great communication (a research active Trust). As well as building in technical expertise to help accurately charge, respondents also highlighted the need to ensure adequate clinical input to help improve accuracy in charging assessments, particularly in specialised areas. 24