Transcript NHS Treatment Costs - Clinical Research Network

Attributing the costs of health & social
care Research & Development
– Understanding AcoRD
Trudi Simmons
Senior Manager – Research Finance & Programmes
[email protected]
1
Intoduction
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Reasons for change
Implementation
Basic principles behind the guidance
The attribution process
Common problems in attributing
costs
• Question and answer session
2
Reasons for change
Primary reasons are:
• Improving the consistency of cost
attribution; and
• Encouraging more consistent funding of
the costs of research
3
Implementation 1
• AcoRD agreed by England
– Adopted by Scotland, Wales & NI
• Draft documents shared with stakeholders
across UK in advance of publication
• DH taken on board issues and concerns
– Working Group established to look at key issues
around implementation
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Implementation 2
• AcoRD published on the DH website in
May 2012. Now on the Gov website at
https://www.gov.uk/government/publications/guidance
-on-attributing-the-costs-of-health-and-social-careresearch
• Applies to new grant applications
submitted after 1 October 2012
• AcoRD will not be applied
retrospectively to studies funded before
1 October 2012
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Principles of AcoRD
• Based on original principles set out in
HSG(97)32
• Uses the same three cost categories and
definitions as HSG(97)32
• Focuses on why an activity takes place
rather than where or by whom
• Focuses on the Primary Purpose of an
activity
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Main difference between AcoRD
and ARCO
DH will meet some research costs for charityfunded research taking place in the NHS,
where the research grant funder is a member
of the AMRC
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Format of Guidance
Three sections
• Main section that covers the background,
principles and attribution process
• Annex A provides an Exemplar list of
activities and where they should be
attributed
• Annex B provides a set of Frequently
Asked Questions (FAQs)
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Annexes A and B
• The Exemplar lists and FAQs will be
updated on a periodic basis in response
to issues raised by users
• Must use most up-to-date FAQs
• Revised versions of Annexes A and B
published in April and November 2013.
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Exemplar Lists
• Split into 3 sections – Research, Support
and Treatment
• Research Section has 2 parts
– Part A costs met by all grant funders
– Part B costs met by grant funders except where the
funder is a member of the AMRC when DH will meet
the cost.
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The Categories of Costs
Three types of costs:
• Research costs
• Treatment costs
• NHS Service Support Costs
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Research Costs
• Research Costs are the costs of the R&D
itself that end when the research ends.
They relate to activities that are being
undertaken to answer the research
questions
• Research Costs are met by grant funders
through the award of a research grant
except for PART B costs if funder is an
AMRC member
– DH will meet PART B costs mainly via Research
Capability funding (RCF) and Networks
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Treatment Costs
• NHS Treatment Costs are the patient
care costs which would continue to be
incurred if the patient care service in
question continued to be provided after
the R&D study had stopped
• NHS Treatment Costs are met through
the normal commissioning process (very
exceptionally DH may make a
contribution)
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Excess Treatment Costs
(ETCs)
• ETCs are the difference between the cost
of usual care and the cost of the treatment
provided as part of the study
• Sometimes there are treatment savings
rather than excess treatment costs
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NHS Service Support Costs
• NHS Service Support Costs are the additional
patient care costs associated with the research,
which would end once the R&D activity in
question had stopped, even if the patient care
involved continued to be provided
• NHS Service Support Costs are met from the
R&D budget by the Health Departments of the
United Kingdom
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Attribution Process
• Concept of NHS patient care services
and the premise that the NHS bears the
cost of caring for its patients even when
they are involved in a research study
• NHS patient care service is defined as “a
service provided by, or on behalf of, the
NHS where that service treats, or
contributes to, the care needs of a
patient.”
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Two step approach – step 1
• Identify the core R&D activities the are
being undertaken to answer the research
question and which end when the
research ends. These activities do not
contribute to a NHS patient care service.
• These are Research Costs
• Examples of Research Costs are
contained in Annex A
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Step 2 – NHS Patient Care Service
Activities
Activity that is part of NHS Services must be
split between:
– NHS Treatment Costs
– NHS Support Costs
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Treatment or Support Activity
• An activity is a NHS Treatment activity If it
is integral to the provision of a treatment
regime, whether this is standard or
experimental
• An activity is a NHS Service Support
activity if the patient care activity is
primarily undertaken to facilitate research
or is driven by the NHS duty of care to a
patient, eg to ensure the safety of a patient
participating in research
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The attribution process
Step 1
In the context of this study is the activity a ‘service provided by, or on behalf of, the
NHS where that service treats or contributes to the care needs of a patient’
Step 2
Yes
No
The activity is a
patient care cost.
Is the activity integral
to the provision of a
treatment (or
diagnostic) regime?
Yes
The activity is
a Treatment
Cost
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The activity is a
Research Cost
because it is not
directly contributing to
patient care
No
The activity is
a Service
Support Cost
Is the funder an
AMRC member?
Attribute Research
activities between
Part A and Part B
Treatment Costs
• NHS Treatment Costs are the patient care
costs which would continue to be incurred if
the patient care service in question
continued to be provided after the R&D
study had stopped
• For the purposes of the attribution process it
can be assumed that an experimental
intervention/service being tested will
continue after the end of the study
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Treatment Costs cont’d
• As a rule of thumb most interventions that
are being tested or compared as part of a
study will be treatment costs even if they
are experimental, unlicensed for the
condition, not NICE approved, or there
are no plans to continue with the
intervention after the study has ended
because the CCGs won’t fund
• But placebo or sham treatments are
research costs
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Examples of NHS Support Activities
• The processing of the patient record to
identify patients who may be suitable to
approach to ask if they wish to participate in
a research project;
• Obtaining informed consent;
• Additional investigations, assessments and
tests where the results are required by the
patient’s care team to ensure patient safety
and where arrangements are in place to feed
the results back to the clinician
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Funding Part B Research activities
• If funder is an AMRC member DH will meet
PART B costs
– Annex B FAQ number 42 provides detail on how these costs are
funded - via Networks or from RCF
• If funder not AMRC funder to meet the costs
of Part B activities
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Pharmacy Costs
• Annex B FAQ 43 provides detailed
information on how pharmacy activities
should be attributed
• Activities not covered in the FAQ will
need to be attributed by applying steps 1
and 2
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Common issues
• Attributing the costs of R&D is complex – DH
piloting an Activity Capture and Attribution
Template (ACAT) to help
• No one size fits all
• Need to understand the detail of the study
– Why is the activity taking place?
– What usually happens to a patient?
– What would happen to the patient if they had the same
treatment outside of a research study?
• Network support applies to research taking
place in the NHS or in a NHS service provider
Efficient study design can help to minimise cost
• Seek appropriate advice before grant
submission
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Common attribution mistakes
• Not referring back to the definitions of the 3
types of costs
• Attributing treatment costs as Support or
Research costs
• Assuming because an activity takes place in
the NHS it must be a NHS cost – not true
• Assuming that funding for NHS Support and
Treatment costs works in the same way as
funding for research costs
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