These FAQs collate the answers to the main questions being asked by NIHR Clinical Research Network colleagues (including those asked on behalf of researchers) in relation to the Excess Treatment Costs (ETCs) for studies for which NHS England (specialised services) is the main commissioner.
1.What are the funding arrangements for specialised services transition studies?
There is no nationally collated list of older specialised commissioning studies, and the Excess Treatment Costs (ETC) / funding agreements reached for them. If a study secured its Research Cost funding agreement before the 1 October 2018, the funding decision for the study would remain under the historic arrangements, even if recruitment is still live after this date. For such studies, ETC approval sits with the relevant local / regional specialised commissioning team(s), as budget holders for the associated clinical activity commissioned from local trusts and other commissioned providers. Therefore, the relevant regional teams will need to be contacted for each participating site if you are not sure what ETC arrangement was agreed and/or where arrangements are yet to be made. A positive response to funding ETCs from one regional team does not mean that other regional teams will necessarily follow suit. Researchers are advised not to commence recruitment until they are sure that they have sufficient sites on board to deliver recruitment targets. The lead contact details for each regional / local team are given below. If the study has been funded before the 1st October 2018 and you are unsure who the responsible commissioner is, contact either NIHR Clinical Research Network Coordinating Centre (NIHR CRNCC) or email@example.com to request a responsible commissioner triage decision with details of the study.
2. How do I locate the regional Specialised Commissioning Teams?
Specialised commissioning is organised into seven geographically based teams, or regions. If you do not already have a named contact for a specific study, and wish to discuss ETC arrangements for a study which received Research Cost funding before 1 October 2018, please use the following first points of contact:
North West - firstname.lastname@example.org
South East - email@example.com
North East and Yorkshire - firstname.lastname@example.org
Midlands - email@example.com
London - firstname.lastname@example.org
South West - email@example.com
East of England - firstname.lastname@example.org
Please note that decisions relating to studies receiving research funding approval after 1 October 2018 sit with the new national process.
3. How is ETC funding agreed once a study has been triaged as specialised commissioning?
Only studies that have had their Research Cost funding awarded post 1 October 2018 will be assured through the new national assurance process. Once the study has been triaged by CRN CC, and NHS England (specialised commissioning) has been confirmed as the responsible (or main) commissioner, the supporting documents including final SoECAT and protocol - will be sent to the NHS England specialised commissioning national finance team for assurance. The finance manager will undertake a review and assess the proposed ETCs detailed within the SoECAT taking into account payments that may already be made to commissioned providers under national tariff and NHS contract arrangements. The finance manager may need to liaise with the income manager from the lead trust (or Chief Investigator) to better understand activity associated with the trial protocol (compared to standard care) and complete a Specialised Commissioning Payment Schedule template, the aim of which is to take the costs in the SoECAT and translate them into a form that reflects national tariff and other NHS payment types. The finance manager will be aiming to ensure that ETCs associated with the research protocol are met, without duplicating payments already made for clinical activity under the provider’s NHS contract. A provisional payable average per patient ETC figure will be proposed between the NHS England finance lead and income manager and then checked with the relevant NHS England Programme of Care Board before a final ETC is agreed. The LCRN submitting the study will be notified of the agreed ETC value via a letter sent by email.
4. Process to determine if a study is classed as 'high cost'?
The process for high cost studies is very similar for both NHS England and CCG funded excess treatment costs. The funder notifies NHS England and DHSC of a high cost study when funding is awarded. A high cost study is a study where total ETCs exceed £1 million and/or have an average ETC per patient above £20,000. For specialised services related studies, NHS England will then undertake a clinically led assurance process to ensure the study is of high value to patients and the NHS. For specialised services the relevant Programme of Care Clinical Lead and Regional Medical Director of Commissioning will review and assure the value of the study to the NHS prior to ETC agreement in line with published criteria. The clinically led assurance process will run in parallel to the finance assurance process to agree ETCs.
5. Do the Specialised Commissioning studies contribute towards the threshold?
No, currently studies relating to specialised services are not taken into account in managing the threshold at provider level. The threshold is therefore solely managed in relation to CCG funded studies. ETC funding will therefore be paid by Specialised Commissioning even if a provider has not yet reached the (CCG-based) provider threshold. Instead, an end of year adjustment is made to enable NHS England to benefit from the threshold at national level.
6. How are ETC payments calculated and made?
The process for reimbursing providers for specialised studies funded after 1st October 2018 is very similar to that for CCG funded studies but payments are made by NHS England rather than by the Local Clinical Research Networks. Reimbursement is made to recruiting sites on a quarterly basis, in arrears, based on confirmed patient recruitment data captured in CPMS (number of patients recruited in that quarter multiplied by the agreed payable average ETC payment). As NHS England already has a system to pay commissioned providers, ETC payments for specialised studies are simply added to the relevant quarterly payment run for each commissioned provider.
7. Will local NIHR Clinical Research Networks (CRNs) be able to help researchers with the specialised commissioning process?
The new national process (covering both CCGs and directly commissioned services, including specialised services) has been developed in collaboration with the NIHR CRN Coordinating Centre (CRNCC) and a process map is available to local teams and covered in associated training. Most steps in the process are the same for both CCG and specialised commissioned studies, but a specialised commissioning specific process map will sit alongside the overall process map which is currently being updated, to help clarify any areas of difference. The new national process only applies to specialised commissioning studies where the research funding award (or an award subject to ETC funding approval) was made on or after 1 October 2018. Should you have specific queries regarding the specialised commissioning process not covered in the process map email enquiries to email@example.com