PSP096: Payment of Excess Treatment Costs

This page provides the RRDNs with information relating to the management and payment of Excess Treatment Costs (ETCs) for non-commercial interventional research studies in England that are eligible for NIHR Service Support funding and are registered on the NIHR RDN Portfolio.

It is intended to be read alongside information on the NIHR website and ETC Google Site.

Treatment Costs are the care costs that would continue to be incurred if the patient care service in question continued to be provided following the end of the research study. The difference between the Treatment Cost and the cost of the existing standard treatment is referred to as the Excess Treatment Cost (ETC).  The Department of Health and Social Care (DHSC) is responsible for the ETCs, which are funded through normal commissioning arrangements for commissioning participant care.

At the request of DHSC the NIHR Research Delivery Network (RDN) assumed responsibility for the management of Integrated Care Board (ICB) commissioned ETC payments for all NIHR RDN Portfolio studies that received confirmation of research funding on or after 01 October 2018. This is referred to as the ‘national ETC payments process’.

From the 2020/21 financial year, a new automated system was implemented in the NIHR Research Delivery Network (RDN) Coordinating Centre (RDNCC) which allows for ETC payments to be made to sites incurring the costs. Further information about this system can be found on the ETC Process and Guidance page.

From 1 July 2024, the NIHR RDNCC took ownership of specialised commissioned studies from NHS England (NHSE). These studies will be added to the national system, alongside the ICB and will be expected to meet a provider threshold or a minimum payment trigger and will be paid biannually.

INFORMATION TO BE PROVIDED

A set of payment principles have been established by the RDNCC and agreed with NHSE. This document outlines the studies that are eligible for ETC payments via the national process, the eight payment models available for the Sponsor, organisation types that are eligible to receive ETC payments and the process that will be followed when dealing with data quality issues. These principles complement the ETC guidance published by NHSE. 

The payment principles will be reviewed regularly and updated by the RDNCC.

The latest version of the payment principles can be found on the ETC Payment Timetable 2024/25 page of the ETC Google Site. 

A study and the ETCs associated with it should be correctly recorded on a Schedule of Events Cost Attribution Tool (SoECAT) in line with the ‘Attributing the Costs of health and social care Research and Development (AcoRD)’ guidance. The SoECAT automatically calculates the Per Participant Value (PPV).

The SoECAT, which is completed by the Research Sponsor and Chief Investigator, must be signed off by a RDN-designated AcoRD Specialist or one designated by a devolved administration, prior to being submitted to the RDN Triage Service. The Regional Research Delivery Networks (RRDNs) are available on the NIHR RDN Hubsite.

The RDN Triage Service determines and confirms the responsible commissioner. 

When the commissioner has been assigned and noted in the Central Portfolio Management System (CPMS) study record, the RDN Triage Service notifies the RDNCC Finance Team. For studies where the PPV is greater than £0, the RDNCC Finance team will contact the Sponsor and Chief Investigator, copying in the Lead RRDN, recommending one of eight ETC payment models for the study (for more information please see Section 6). 

During the course of the study, if the Lead RRDN AcoRD Specialist re-authorises the SoECAT due to amendments to the protocol or following a study review, and the changes affect the PPV, the Lead RRDN should email the RDN Triage Service (triagehelpdesk@nihr.ac.uk) so records can be updated. The RDN Triage Service is responsible for uploading the amended SoECAT, updating the ETC PPV and adding an AcoRD attribution note on the CPMS study record. 

For information, the SoECAT is not intended to be used as a tool to derive true site level costs. It serves to provide an approximation of the costs involved in a study.

Payment Model Guidance has been developed to give the Sponsor and Chief Investigator the option of selecting one of eight payment models.  The guidance is designed to lead the Chief Investigator and Sponsor through the decision making process, which is described below and also on the ETC Google Site, allowing for ETC payments to be made to one or more organisations which incur the ETCs. 

The ETC Helpdesk team will review the study and recommend a payment model, contacting the Chief Investigator and Sponsor to get agreement. If needed, the team will arrange a meeting to assist in assigning a model that best fits the study. Once agreed, the payment model is recorded by the ETC Helpdesk team on an Access database.

The Lead RRDN is copied into correspondence and may attend discussions with the Sponsor and Chief Investigator. However, RRDNs are not expected to know or understand the payment models; this is a RDNCC function and responsibility.

Recruitment recorded in CPMS at the time of the NIHR quarterly data cut, together with the payment model recorded on the Access database, is used to calculate the ETC payments. The data cut deadlines can be found on the ETC Google site.  

Any protocol amendment, change to the SoECAT PPV or change to the ETC payment model which occurs during the course of a study, will be reflected at the next NIHR RDN quarterly data cut. For example, if the payment model changes from model 2 to model 3 during Quarter 3 (Q3), model 3 will be used to allocate the ETC payments for the study for confirmed Q3 recruitment onwards. Model 3 would also be used to allocate payments for any retrospective recruitment recorded for Q1 and Q2. 

ETCs for all studies led by Northern Ireland, Scotland or Wales, with participating sites in England, are paid to English recruiting sites as noted in the CPMS using payment model 1, unless otherwise agreed with the Sponsor and Chief Investigator.

For further information about the payment models please see the Payment Model Guidance on the ETC Google site. 

• Payment Model 1 ETC payments will be made to the English site at which the recruitment is uploaded to at the time of the NIHR RDN datacut deadlines 

• Payment Model 2  ETC payments will be made to a single site or organisation irrelevant of the sites that have uploaded recruitment. 

• Payment Model 3 The total ETCs incurred for all sites will be split by a percentage to the organisations that are incurring the costs. 

• Payment Model 4 The total ETC incurred for all sites will be split as a percentage to the organisation that are incurring the costs. 

• Payment Model 5 The total ETCs incurred at a recruiting site will be paid directly to the intervention site.  

• Payment Model 6 The ETCs are attributed at a rate which reflects the costs born at an intervention site and a control site in a cluster randomised study. Therefore, the control site could be £0 ETCs and the intervention could be greater than the PPV provided on the SoECAT, due to the PPV on the SoECAT being an average of total recruitment. 

• Payment Model 7 allows ETCs to be allocated to intervention cost sites where an intervention takes place in a Cluster Randomised Study. This is a variation of model 6.

• Payment Model 8 ensures ETCs from multiple recruiting sites are allocated to multiple intervention cost sites. This model can be used for cluster randomised studies.  

The responsible commissioner and PPV information for studies incurring ETCs are recorded on the Network Support tab of a study record in CPMS. This information is updated by the RDN Triage Service. 

Payment model information is not displayed on the CPMS study record, but can be viewed in the assigned payment models spreadsheet. 

Recruitment data for studies on CPMS which incur ETCs are automatically pulled into the NIHR Open Data Platform (ODP) ETC dashboard and can be found using the 'Excess Treatment Costs Annual Cut' app. This dashboard shows the cumulative ETCs which have been incurred in each quarter of the financial year and calculates the payments due at a RRDN and a Delivery organisation level from the recruitment data and ETC PPV provided in CPMS at the point of the NIHR RDN quarterly data cut.  The data cut is taken quarterly and schedules are distributed to the RRDN Host organisation, payments are made biannually. For key dates, please see the ETC Google site. 

The dashboard also allows ODP users to visualise the data, monitor the ETCs incurred for specific Providers against their Threshold or Minimum Payment Trigger, and the ETC payments made. 

Payment model information can be seen on the ETC dashboard on the ETC Mapping tabs and are available on the ETC Models by study

The payment model assigned to a study is recorded on an Access database by the ETC Helpdesk team. This database also stores information about the sites which have been selected to receive the ETC payments, and any payment ratios involved. This data is then pulled through the ODP in order to calculate the ETC payments for each site. 

RRDNs are not able to view the Access database but the data is available in the ETC Mapping tabs on ODP. This information is made available post datacut, after checks have been carried out by the RDNCC.

ETC payments are calculated quarterly and each RRDN Host Organisation is advised of the amounts. However, ETC payments to the RRDN Host Organisation are made biannually, combining Q1 & Q2 and Q3 & Q4. The RRDN Host Organisation will then distribute the ETC payments to the relevant Delivery organisations within 30 days. For all key dates please see the ETC Google Site.  The ETCs incurred for an organisation are calculated as shown below:

• ETC Per Participant Value (PPV) in CPMS relating to the quarter where the recruitment took place, multiplied by

• the number of participants confirmed in CPMS at the time of the RDNCC quarterly data cut, multiplied by

• the payment ratio % incurred by the intervention cost site as dictated by the payment models. 

Any ETCs incurred relating to retrospective recruitment in that same financial year will be calculated using the ETC PPV recorded from CPMS at the point the datacut was taken. 

Unless agreed otherwise by NHSE, only confirmed recruitment data is used in calculating payments. RRDNs are asked to ensure all recruitment is confirmed before the Q4 data cut in any given financial year, as retrospective ETC payments from previous financial years will not be made.

Where a study is deemed to have a cost saving (negative PPV) due to the research activity, no negative value will be used in the calculation for the ETCs incurred, as this would negatively impact the ETC payments made to that organisation.

ETC payment calculations are subject to either a Provider Threshold or a Minimum Payment Trigger before the biannually  payments are made. See Section 9 below.

The RDNCC produces a payment schedule for each RRDN which details the ETC payments incurred by, or to be made to, each provider, and asks DHSC to make the payments to the RRDN Host Organisations. 

Upon receipt of the payment from DHSC, RRDN Host Organisations forward the ETC payments to the Delivery organisations based on the information in the payment schedule within 30 days of the payment being received. 

The ETC payment timelines are available here. 

Providers are required to absorb ETCs up to their Threshold value for their organisation before additional ETCs are reimbursed. 

NHSE reviews and sets Provider Thresholds for each NHS Trust and Independent Sector Healthcare Provider (ISHP) sites on an annual basis. Thresholds may also be applied to Care Homes, Charities, Companies, Hospices and Universities at the discretion of NHSE.

The value of the Provider Threshold is communicated to NHS Trusts by NHSE at the beginning of the financial year and will be made available on the ETC Google Site once NHSE has provided the information to the RDNCC.

The RDNCC monitors the ETCs being absorbed by each Provider and will make payments only when the annual threshold has been reached. No payments will be made to providers that have not reached their threshold. 

For primary care sites including General Practice services, General Dental services, Community Pharmacy services and Optometry services, a nominal value of £500 of ETC payments incurred has to be reached before a payment will be processed. 

Once this Minimum Payment Trigger has been reached once, any further payments in that financial year will be paid regardless of the value. All ETCs incurred will be fully reimbursed within a financial year, regardless of the £500 nominal value.

The Minimum Payment Trigger has been set at £500 to reduce the administrative burden of making multiple payments of small value.

RRDN Host Organisations do not require, and should not request, an invoice from Delivery organisations in order to make an ETC payment. The payment schedules produced and sent by the RDNCC Finance Team, and available through the ODP app, act as an invoice and proof of payment due.

RRDN payments to Providers should be made within 30 days of receiving the payment from DHSC.

The RDNCC provides RRDN Host Organisations with a reconciliation template including the payments in the current year and brought forward values for the prior year. This should be reconciled to the payments made by the RRDN Host Organisation on a quarterly basis and returned to etc.helpdesk@nihr.ac.uk within the timelines stated.

Where ETCs associated with a study are above the High Cost threshold (≥£1 million over the lifetime of the study, or ≥£20,000 per participant) the study will be reviewed at a national level by the High Cost Review Panel, comprised of DHSC and NHSE officers, as to its value to the NHS before a decision to fund the ETCs is made. For any queries please contact england.highcostetc@nhs.net

ETCs for High Cost studies are sometimes paid directly to the provider by DHSC, and sometimes via the national payment process. This is at the discretion of DHSC and NHSE.

A dedicated RDNCC helpdesk is available to support the Payment Model Guidance along with the payments process, and signpost enquiries to the correct organisation and/or team.

Prior to contacting the ETC Helpdesk, RRDNs are asked to visit the ETC pages on the NIHR website and the ETC Google Site. If neither of these sites provide the response, the ETC Helpdesk can be contacted on etc.helpdesk@nihr.ac.uk.

 The ETC Helpdesk team aims to respond fully to all enquiries within five working days. 

AcoRD: Attributing the cost of health and social care Research and Development

CPMS: Central Portfolio Management System

DHSC: The Department of Health and Social Care

ETC: Excess Treatment Cost

ICB: Integrated Care Board

ISHP: Independent Sector Healthcare Provider

NHSE: NHS England

NIHR: National Institute for Health and Care Research

ODP: Open Data Platform

Q1/2/3/4: Quarter 1/2/3/4

PPV: Per Participant Value (sometimes referred to as the Per Patient Value)

RDN: Research Delivery Network

RDNCC: Research Delivery Network Coordinating Centre

RRDN: Regional Research Delivery Network

SoECAT: Schedule of Events Cost Attribution Tool

Version number: 2.3 

Effective from date: 1 October 2024

Jen Hartley

Finance Business Partner

Email: jen.hartley@nihr.ac.uk