Guidance for Applicants to CRN Wessex Excess Treatment Costs (Etcs) Funding in 2017/18

Guidance for applicants to CRN Wessex Excess Treatment Costs (ETCs) Funding in 2017/18 for Non-Commercial Research on the NIHR CRN Portfolio

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, 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. In response to this, the former Hampshire and Isle of Wight Comprehensive Local Research Network (HIOW CLRN) managed an ETC funding stream, where funding was top-sliced from the South Central Strategic Health Authority budget. Under this model, Principal Investigators from NHS organisations within the region applied to HIOW CLRN for the costs of the research treatment which were over and above the costs of standard care.

Funding

The ETC fund managed by CRN Wessex totals £171,841. Please refer to Table 1 for the breakdown of contributions from Clinical Commissioning Groups (CCGs) and Specialised Commissioning covering Hampshire, the Isle of Wight, Dorset and Wiltshire (South).

Table 1 * Proposed Budget Contributions by CCG

Hampshire & Isle of Wight
CCG / Population / 2015/16 Budget Contribution (£)
NHS North East Hampshire and Farnham CCG / 217, 282 / 9,361
NHS North Hampshire CCG / 215, 470 / 9,361
NHS West Hampshire CCG / 540, 227 / 25,181
NHS South Eastern Hampshire CCG / 208, 997 / 9,361
NHS Southampton City CCG / 266, 600 / 11,998
NHS Fareham and Gosport CCG / 199, 960 / 9,361
NHS Portsmouth CCG / 216, 691 / 9,361
NHS Isle of Wight CCG / 141, 058 / 6,724
Dorset
CCG / Population / Budget Contribution (£)
NHS Dorset CCG / 766, 749 / 34,411
Wiltshire
CCG / Population / Budget Contribution (£)
NHS Wiltshire CCG(South) / 142,000 / 6,724
Specialised Commissioning
Wessex / 40, 000
Overall Budget / 171,841

*Excludes outside Wessex LAT

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 CCG, PIs will be required to provide information regarding any additional subvention funding that may be available from DH.

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 DH

·  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

·  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

·  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.

·  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 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 ETCsfrom their patient care budget should this situation arise

Reporting

A mid-year and end of year report will be submitted to Wessex CCGs and Specialised Commissioning summarising the actual spend against the allocated budget to date and projected spend to year end. Please refer to Appendix 3.

Appendix 1 – Schedule of CRN Wessex Executive Group Meetings

Meeting Dates 2017/18 / Application Deadline 2017/18
21st April / 7th April
18th May / 4th May
15th June / 1st June
13th July / 29th June
21st September / 7th September
12th October / 28th September
16th November / 2nd November
14th December / 30th November
11th January / 28th December
8th February / 25th January
8th March / 22nd February

Appendix 2 – Invoicing Guidance

Excess Treatment Costs Funding

Invoicing Guidance 2017/18

·  Please complete the CRN Wessex ETC Invoicing Form

·  Payment will be quarterly in arrears. Completed Invoice forms should be submitted by the following deadlines:

Recruitment Period / Invoice Deadline
1st April to 30th June / 31st August
1st July to 30th September / 30th November
1st October to 31st December / 28th February
1st January to 31st March / 31st May

·  Invoice Forms should be submitted to

·  Once the amount has been agreed a Purchase Order number will be raised by CRN Wessex and supplied to the organisation requiring payment to allow an invoice to be raised.

·  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 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 ETCsfrom their patient care budget should this situation arise.

Appendix 3 - Reporting

Excess Treatment Costs

Quarterly Report for CCGs and Specialised Commissioning

Quarter 1 2016/17

1.  Applications received that were not funded

2.  Summary of Studies where ETC funding was confirmed

Study Title / Description of Activity incurring ETCs / Funding Commitment for 2015/16 / Actual Spend to date / Total Income / Balance of Allocation

3.  Invoice forms that were rejected or where amendment was requested