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Guidance for applicants to CRN Wessex excess treatment costs (ETCs) funding in 2020/21 for non-commercial research on the NIHR CRN Portfolio

 

Contents

Background

The cost of the treatment provided within a research study may be more expensive than the cost of standard care, hence could result in excess treatment costs. The Department of Health and Social Care (DHSC), through the guidance note ‘Attributing the cost of health and social care Research & Development (AcoRD)’, states that treatment costs associated with research are patient care costs and should be met through the patient care budget. At the beginning of the financial year NHS Trusts cannot always be aware of the ETCs that may be incurred throughout the course of the year, so it has proved difficult for organisations to meet these costs at relatively short notice and hence ETCs have historically proved to be a block to research.
 
From 1 st October 2018 a national model was implemented for all studies with ETCs met by CCGs and for all studies funded from 1 st October 2018 with ETCs met by specialised commissioning (SC). NHS Organisations will be reimbursed for the ETCs relating to qualifying studies. Further information is available

National guidance states that studies incurring ETCs for specialised commissioning related patient care activities that were funded prior to 1 st October 2018 should be managed under existing arrangements and so the Wessex ETC fund will continue for these studies only.

Application Process

Principal Investigators (PIs) will complete the CRN Wessex ETC application form (available from the CRN Wessex website) to provide a comprehensive description of the activity that is incurring the excess treatment costs. Where ETCs fall at £1000 or less per NHS Organisation, the Trust incurring the cost will be expected to meet the ETCs. Where ETCs exceed £20,000 per NHS organisation investigators will be required to provide information regarding any additional subvention funding that may be available from DHSC.

Applications received by CRN Wessex will be reviewed thoroughly by the CRN Wessex Executive Group. Please refer to Appendix 1 for Executive Group meeting dates and submission deadlines. Activity for which funding is requested must be correctly attributed as a treatment cost, in line with AcoRD guidance, and the amount requested should only be the additional cost of the research treatment once the cost of standard care has been subtracted.
 
Information required by the CRN Wessex Executive Group to review an application:
  • Full details of the ETC being claimed, including the basis for cost calculation (e.g. cost per patient entered into the research study and cost saving if applicable)
  • A summary of ETC funding that is being requested in the current financial year and subsequent financial years
  • Detail of any subvention funding awarded by the DHSC
  • The recruitment goal in the current financial year and subsequent years
  • A copy of the approved study protocol
  • A copy of the submitted grant application form
  • A copy of the schedule of events
  • UKCRN Portfolio Study ID number
Applicants and the NHS organisations incurring the costs will receive confirmation in writing of the decision by the CRN Wessex Executive Group.

Payment of ETCs

  • Whilst the national ETC process is being piloted, it is intended that funding from the Wessex ETCs fund will remain available for specialised commissioning ETCs associated with studies that applied for research funding prior to 1st October 2018. It is possible that national guidance may change and in response, local arrangements may also change within this pilot phase.
  • Funding will be conditional on timely submission of recruitment data onto EDGE and to the NIHR Portfolio database
  • Funding will be payable only for the ETCs associated with treatment that has been provided
  • Payment will be quarterly in arrears. Applicants should complete an Invoicing Form (available on the CRN Wessex website). Please refer to appendix 2 for invoicing guidance.
  • The first payment will be made upon the £1,000 threshold being incurred
  • A funding application is required for subsequent years and should be submitted to CRN Wessex in February of each year
  • CRN Wessex shall be under no obligation to make any payment on claims received more than 9 months after the costs have been incurred by the trial and there will be a general presumption against paying invoices received after this date unless an extension has been agreed in writing
  • There is a possibility that ETCs incurred may exceed the limited funding available if all studies recruit to time and target. NHS Organisations must be prepared to go at risk and meet the ETCs from their patient care budget should this situation arise

Reporting

A mid-year and end of year report will be submitted to Specialised Commissioning summarising the actual spend against the allocated budget to date and projected spend to year end.

Appendix 1 – Schedule of CRN Wessex Executive Group Meetings

Meeting dates 2020/21
ETCs Application Deadline 2020/21
Thursday 19 March 2020 Thursday 5 March 2020
Thursday 23 April 2020 Thursday 9 April 2020
Thursday 21 May 2020 Thursday 7 May 2020
Wednesday 24 June 2020 Wednesday 10 June 2020
Wednesday 22 July 2020 Wednesday 8 July 2020
Wednesday 2 September 2020 Wednesday 19 August 2020
Wednesday 7 October 2020 Wednesday 23 September 2020
Wednesday 18 November 2020
Wednesday 4 November 2020
Wednesday 16 December 2020 Wednesday 2 December 2020
Wednesday 13 January 2021 Wednesday 30 December 2020
Wednesday 17 February 2021 Wednesday 3 February 2021
Wednesday 17 March 2021 Wednesday 3 rd March 2021
 

Appendix 2 - Excess Treatment Costs Invoicing Guidance 2020/21

  • Please complete the CRN Wessex ETC Invoicing Form
  • Completed Invoice forms should be submitted by the following deadlines:
ETCs incurred
Invoice Deadline
1 April to 30 June 31 August
1 July to 30 September 30 November
1 October to 31 December  28 February 
1 January to 31 March 31 May
 
  • Payment will be quarterly in arrears and the first payment will be made upon the £1,000 threshold being incurred
  • Invoice Forms should be submitted to clare.rook@nihr.ac.uk
  • Once the amount has been agreed, if the £1,000 threshold has been reached a purchase order number will be raised by CRN Wessex and supplied to the organisation requiring payment to allow an invoice to be raised. Where the £1,000 threshold has not yet been reached, the amount will be recorded and added to future costs incurred until £1,000 threshold is reached.
  • Funding will be conditional on timely submission of recruitment data onto EDGE and to the NIHR Portfolio database.
  • Funding will be payable only for the ETCs associated with treatment that has been provided.
  • A funding application is required for subsequent years and should be submitted to the CRN Wessex in February of each year.
  • CRN Wessex shall be under no obligation to make any payment on claims received more than nine months after the costs have been incurred by the trial and there will be a general presumption against paying invoices received after this date unless an extension has been agreed in writing.
There is a possibility that ETCs incurred may exceed the limited funding available if all studies recruit to time and target. NHS Organisations must be prepared to go at risk and meet the ETCs from their patient care budget should this situation arise.

Access to 2020/21 forms 

For access to the following forms, please contact clare.rook@nihr.ac.uk
1. Excess Treatment Costs Funding Application Form 2020/21 – for specialised commissioning studies funded before 1 October 2018.
2. Specialised Commissioning Excess Treatment Costs Invoicing Form 2020/21