Introduction
The Health and Care Act 2022 (the Act) established integrated care boards (ICBs) as new NHS bodies, fulfilling our long-term policy ambition of giving local systems responsibility for managing population health needs, tackling inequalities, and by delivering high-quality, integrated care.
ICBs will take delegated authority to discharge a host of NHS England statutory functions. From 1 April 2023, all ICBs will assume delegated responsibility for primary care services, and ICBs will also enter into joint working arrangements with NHS England to jointly commission some specialised services. It is intended that NHS England will delegate further direct commissioning functions to ICBs from April 2024.
When ICBs assume responsibility for the delegated functions, the liability for those functions moves to the ICB. NHS England will retain overall accountability for the discharge of its responsibilities under the Act and therefore requires the necessary assurances that its functions are being discharged safely, effectively and in line with the legal requirements. NHS England remains legally accountable to the Department of Health and Social Care (DHSC), led by the Secretary of State, which is in turn accountable to Parliament.
The Operating Framework for NHS England sets out the accountabilities and responsibilities of NHS England and ICBs.
This framework is intended to provide clarity on NHS England’s expectations on how ICBs will provide assurance to NHS England that they are exercising the delegated functions safely, effectively and consistently within legislation regulations and statutory guidance. It will also set out the information that will be collected as part of the oversight of commissioning functions.
Purpose and principles
Purpose and ambition
The delegation of NHS England’s primary care commissioning responsibilities to ICBs is a key enabler for supporting ICBs to achieve the four core purposes for which they were established. By giving ICBs responsibility for a broader range of functions, they will be able to design services and pathways of care that better meet local priorities. They will also have greater flexibility to integrate services across care pathways, ensuring continuity for patients and improved care quality and health outcomes for the local population. This will increase as more direct commissioning functions are delegated in due course.
We recognise that during the period after inception that there will be a period of transition as ICBs embed the delegated functions into their wider commissioning responsibilities. ICBs will all be at varying stages of maturity and will face pressures to restore and increase access to services as a result of the disruptive impact of the Covid-19 pandemic, which will also have impacted on the delegated functions that ICBs receive.
Taking all this into account, our approach to assurance is intended to be supportive, developmental and collaborative whilst minimising any legal or regulatory risks to both NHS England and ICBs. ICBs will be supported to identify emerging issues or risks at the earliest opportunity and, in turn, to identify where support might be needed for improvement.
Where functions have not been delegated, the existing frameworks will remain in place.
Principles
Our engagement on the development of this framework has resulted in a set of principles which should underpin the way that assurance of the delegated functions is delivered:
- Acknowledges ICBs’ autonomy and responsibility for improving care quality and health outcomes for their local populations.
- Enables ICBs to plan, develop and integrate services across wider care pathways.
- Provides a proportionate approach that minimises the regulatory burden and reporting requirements on ICBs.
- Draws, where possible, on existing processes and resource.
- Aligns to the NHS oversight principles detailed in the NHS Oversight Framework and focuses on specific areas of oversight and assurance relating to the delegated primary care commissioning functions.
- Creates a standardised and consistent assurance process that provides NHS England with a robust overview of the exercise of the delegated functions by ICBs.
- Developmental: aimed at identifying development needs and supporting improvement, not just identifying areas of poor performance, and sharing learning across systems.
- Positive: there should be a positive and collaborative approach to the way that the assurance framework is delivered.
Scope of this framework
The primary care functions being delegated are set out in the standard Delegation Agreement between NHS England and each ICB. ICBs will have delegated responsibility for the contract management and assurance of providers/contractors. This Framework will therefore focus on the responsibilities being exercised by ICBs and not on the assurance of providers/contractors themselves.
The assurance of the NHS England Reserved functions is not in scope of this framework as these will remain the responsibility of NHS England national and regional teams. These are set out in Schedule 3 of the delegation agreement.
NHS England’s approach to oversight is described within the NHS Oversight Framework and this document is aligned with the principles of oversight that this describes, as well as the National Guidance on Quality Risk Response and Escalation in Integrated Care Systems. The Oversight Framework requires that NHS England and ICBs together agree the specific arrangements for each system to ensure effective and proportionate oversight, reflecting local delivery and governance arrangements. These are set these out within an agreed Memorandum of Understanding (MoU). The approach to the assurance of the delegated functions will be included within the MoU for each system to ensure this is aligned with the overall approach to oversight that has been agreed between the parties.
Elements of assurance
The assurance of the delegated functions will be structured around a number of domains that relate specifically to the core commissioning and contracting requirements that have been set out in the standard delegation agreement. For consistency across each of the delegated functions, the assurance requirements have been grouped into four distinct domains, each covering core components of commissioning assurance (figure 1).
It is important to note that there will be some differences in the elements required for assurance between contractor groups due to differences in the functions that have been delegated. The expectations across functions and domains expectations have been developed jointly with national and regional teams and are set out in Table 1. Much of the information to demonstrate assurance will be collected through pre-existing data collections or through the self-declaration process, so as not to create additional burden on ICBs.
Domain 1: Compliance with mandated guidance issued by NHS England
This domain concerns assurance that ICBs are complying with all nationally set operating procedures, including confirmation that operating procedures are updated in line with changes to national amendments to guidance, where necessary.
Domain 2: Service provision and planning
This domain covers areas of assurance related to how ICBs identify local health needs, ensure that the necessary services are in place and commission new services where unmet needs are identified. This domain also includes general commissioning planning assurance, where appropriate.
Domain 3: Contracting
This domain covers elements of assurance related to how contracting takes place, that local processes comply with the necessary published guidance for contracting, and that ICBs are participating appropriately in any contracting specific processes that are required.
Domain 4: Contractor/Provider compliance and performance
This domain covers elements of assurance related to how ICBs evidence due diligence in respect of in year contract management, and how ICBs ensure that appropriate levels of contractor/ provider performance and compliance are being met.
NHS England primary care commissioning assurance domains
General
Domain (delegated function/responsibility) |
What will NHS England need to be assured of? |
|
Compliance with the Delegation Agreement |
ICB’s compliance with the terms and associated responsibilities and measures required to ensure the effective and efficient exercise of the Delegated Functions. |
|
Governance structure in place for commissioning and contractual functions |
The ICB has appropriate governance structures in place for commissioning and contractual functions for the delegated services to enable the commissioning and delivery of high quality care. |
Pharmaceutical services
Domain (delegated function/responsibility) | What will NHS England need to be assured of? |
| Compliance with mandated guidance issued by NHS England |
ICB’s understanding of and compliance with all nationally set operating procedures and policies (e.g. the Pharmacy Manual, Pharmaceutical Regulations). See Schedule 9 of the delegation agreement. |
| Service provision and planning |
ICB’s active involvement with all Pharmaceutical Needs Assessments (PNA) in their area, as undertaken by HWBs. |
| Assurance that there are no material gaps (as defined by the PNA) in pharmaceutical provision and the ICB has taken action to address any gaps identified. | |
|
All payments made to community pharmacy contractors, dispensing appliance contractors and dispensing doctors are as outlined in the Drug Tariff, in line with usual NHS Business Services Authority (NHSBSA) custom and practice such as for lost batches or are made within other formal contractual routes such as LPS contracts or NHS Standard Contract. | |
|
All contracts put in place for local enhanced services are in line with The Pharmaceutical Services (Advanced and Enhanced Services) (England) Directions 2013 | |
|
The ICB has obtained written consent of NHS England prior to making any new LPS schemes. | |
|
All applications received for the Pharmaceutical List by the ICB related to community pharmacy contractors, dispensing appliance contractors and dispensing doctors have been decided within their regulatory timescales. Reasons are provided where this is not the case. | |
| Contractor/provider compliance and performance | Compliance with all guidance/regulations for contractor compliance. The ICB has taken appropriate action where necessary. This includes (but is not limited to):
|
| Dispensing doctors:
|
Ophthalmic services
Domain (delegated function/responsibility) | What will NHS England need to be assured of? |
| Compliance with mandated guidance issued by NHS England |
ICB’s understanding and compliance with relevant policies and guidance for discharging the delegated functions (e.g. Eye Health Policy Book) See schedule 9 of the delegation agreement. |
| Service provision and planning |
The ICB has processes in place to plan and manage service provision, including:
|
| Contracting |
The ICB is managing the processes involved for new, varied and terminated contracts effectively and efficiently. This includes (but is not limited to):
|
| Contractor/provider compliance and performance |
|
Dental services
Domain (delegated function/responsibility) | What will NHS England need to be assured of? |
| Compliance with mandated guidance issued by NHS England |
ICB’s understanding and compliance with relevant policies and guidance for discharging the delegated functions (e.g. Policy Book for Primary Dental Services) See Schedule 9 of the delegation agreement. |
| Service provision and planning |
The ICB has processes in place to plan and manage service provision, including:
|
| Contracting |
The ICB is managing the processes involved for new, varied and terminated contracts effectively and efficiently. This includes (but is not limited to):
|
| Contractor/provider compliance and performance |
The ICB has taken appropriate compliance action where necessary. This includes (but is not limited to):
The ICB shares information on practice complaints and concerns with regulatory bodies:
|
Primary Medical Services
Domain (delegated function/responsibility) | What will NHS England need to be assured of? |
| Compliance with mandated guidance issued by NHS England |
ICB’s understanding and compliance with relevant policies and guidance for discharging the delegated functions (e.g. Primary Medical Care Policy and Guidance Manual) See Schedule 9 of the delegation agreement. |
| Service provision and planning |
Management of processes for the following commissioning activities:
|
| Contracting | Processes in place for the collection of data relating to decisions on Discretionary Payments or Support |
| Implementation of Premises Costs Directions Functions | |
| Contractor/provider compliance and performance |
Systems and processes in place to manage quality and performance. The ICB has taken appropriate action where necessary. This includes (but is not limited to):
|
What is required to demonstrate assurance?
Compliance with the Delegation Agreement and this Assurance Framework can be demonstrated in many different ways. NHS England encourages ICBs to reflect regularly on their compliance status, rather than just through annual self-declaration. Both formal and informal touchpoints will exist through ordinary business, and assurance discussions should be woven into these meetings. Annex 1 provides examples of the types of ways an ICB might demonstrate compliance against each of the four domains, however this is not an exhaustive list.
Support, development and risk management
ICBs will maintain a close working relationship with NHS England regional teams, as set out in the Operating Framework. This will maximise an ICB’s ability to deliver high quality services, undertake transformation activity and access support as required. It is expected that primary care development and transformation will take place in the context of wider system change, with system partners that might be outside of the NHS, for example Local Authorities. It is important that any support or development needs identified by ICBs are discussed with NHS England regional colleagues as early as possible, to prevent risks and issues from arising and to ensure high quality commissioning.
Similarly, where an ICB identifies a risk, ICBs should take steps to ensure it is assessed and mitigated as soon as possible. The Delegation Agreement sets out the requirement for ICBs to maintain a risk register in respect of the exercise of the delegated functions. The risk register should allow for the identification and monitoring of emerging risks associated with the exercise of the delegated functions. It should capture all information needed to manage risk appropriately and determine whether any risks should be escalated through internal governance structures (such as audit and quality committees) and/or to NHS England.
The ICB should regularly review the risks associated with the exercise of the delegated functions to ensure the risk reflects the most current position and that the controls and mitigations are still the most appropriate response.
Where quality risks or concerns have been identified, these should be managed and escalated in line with the NQB’s Guidance on Quality Risk Response and Escalation.
Intervention
As described earlier in this framework, whilst ICBs are liable for the discharge of the delegated functions, NHS England remains accountable for their discharge, which means that NHS England has a vested interest in ensuring compliance. NHS England will always seek to support an ICB to address issues of compliance, but it must also be able to both address and manage non-compliance through more formal means if a collaborative and supportive approach has not been successful. Whilst NHS England expect that most non-compliance will be able to be resolved informally, NHS England has a range of powers designed to ensure safe delivery of the delegated functions:
- Powers derived from the delegation agreement – subdivided into explicit and implicit powers.
- Powers derived from mandatory guidance or contractual notices.
- Wider NHS England powers derived from legislation, including the power of direction.
Powers derived from the Delegation Agreement
The Delegation Agreement sets out the activity expected to be undertaken by ICBs. Where this is not achieved, the delegation agreement contains a set of breach provisions that:
- Require the ICB, within ten days of the noncompliance, to provide a report to NHS England detailing the reasons for the noncompliance, and a plan to remedy it.
- Require a senior ICB representative to attend a meeting, within ten days of the noncompliance taking place.
- Substitute/override the decision of the ICB.
- Terminate the agreement.
The Delegation Agreement also contains provisions to:
- Strengthen information and reporting requirements.
- Strengthen the risk register requirements.
- Withdraw NHS England staff from the delegated arrangement.
- Imposing a financial penalty by reducing budgets – if the non compliance affects NHS England’s ability to fulfil its own obligations.
Mandated guidance/contractual notices
Whilst the delegation agreement contains the specific requirements for exercising the delegated functions, where temporary arrangements or additional requirements arise, they can be addressed through the use of mandated guidance. Contractual notices can also be used to provide instructions on the discharge of the delegated functions. Both of these can also be used to place parameters around the exercise of the ICB’s delegated functions until the issue has been remedied.
Wider legislative powers
NHS England was granted a host of powers under the Health and Care Act 2022, some of which centre on how we interact with ICBs. There are particular provisions that address situations where functions are not being discharged in an appropriate way/to an appropriate standard, allowing for NHS England to address the issues through:
- Powers to direct ICBs as to the form and content of their annual reports.
- Powers to require an ICB to provide NHS England with any document or information.
- Powers to direct an ICB where NHS England is satisfied that it is failing to discharge its functions, or where there is a significant risk that this is to be the case.
- Powers to appoint and remove a chair of an ICB.
- Powers to publish guidance on the exercise of ICB functions, to which they must have regard.
When a cause for concern arises, NHS England will consider each situation on its own facts and merits in determining the appropriate response.
Annual self-declaration
Assurance of the delegated primary care functions will be supported by ICBs completing an annual self-declaration (Annex 2) alongside the provision of other evidence and examples of compliance. The purpose of the self-declaration is to provide assurance that ICBs have the necessary processes and mechanisms in place to meet core commissioning and contracting standards, as set out in the delegation agreement, and is based around the four commissioning domains for each of the delegated functions.
ICBs will need to complete the self-declaration retrospectively by the end of the financial year, ensuring that the information reported is accurate and up to date. Returns should be reviewed through the ICB’s internal audit process and ICBs will need to report to NHS England Regional teams if any audit recommendations are made and implemented. A named officer will need to sign off the self-certification as accurate and to confirm the ICB’s compliance with the delegation agreement.
Regional teams will review self-declaration submissions, identifying trends, informing discussions with ICBs and to highlight areas of potential regional risk. Outputs of the self-declaration process will be used to support wider discussions on NHS England’s overall assurance of delegated commissioning functions.
Annex 1 – Examples of the type of data that could be provided to demonstrate assurance
Domain 1 – Compliance with all mandated guidance and legislation
This domain is evidenced through the self-declaration returns, and through ongoing compliance with the Delegation Agreement and legislation/regulations relevant to each contractor group. Soft intelligence discussed in regular meetings is expected to evidence compliance in these areas, as the legislation and DA underpin the day-to-day commissioning and contracting activities.
Domain 2 – Service provision and planning
The below table provides some examples of the types of data or information that could be provided to evidence assurance against this domain, in each contractor group. This list is not exhaustive.
Pharmaceutical services
- List of Pharmaceutical Needs Assessments (PNA) engaged with in the last year.
- PSRC (or alternative) minutes detailing PNA activity.
- Market Entry and Exit application data.
- List of any new Local Pharmaceutical Services (LPS) schemes agreed.
- Summary of Fitness to Practise decisions for LPS superintendents.
- PSRC minutes detailing Pharmaceutical List decisions/ justifications provided where timescales not met.
- PCSE/NHS Resolution reports on Pharmaceutical List appeals/ overturned decisions.
Optometry
- Evidence of needs assessments having been undertaken and considered.
- Evidence of having considered and understood implications of practice closures.
- Local care home provision details.
- Confirmation of number of enhanced services contracts the ICB has in place.
- Confirmation that the ICB has processes for identifying patient access concerns.
Dentistry
- Evidence of Oral Health Needs Assessments having been undertaken and considered.
- Use of the mapping tool, highlighting areas with low access rates.
- Local access data.
- Evidence of establishing new service providers and procurement of new services in accordance with NHS England guidance.
- Evidence of having considered and understood implications of practice closures.
- Evidence of process for assessing how legal duties apply and of suitable involvement activities.
Primary medical services
- Local Incentive Scheme (LIS) details.
- List closures and patient list dispersals.
- Practice mergers and contractual closures.
- Evidence of process for assessing how legal duties apply and of suitable involvement activities.
- Procurement (activity and outcomes) and contracts data.
Domain 3 – Contracting
Below are some examples of the types of data or information that could be provided to evidence assurance against this domain, in each contractor group. This list is not exhaustive.
Pharmaceutical services
- Annual reports generated by NHS BSA.
- List of services for which Local Enhanced Services (LES) contracts were put in place in the past year.
- List of any new LPS schemes agreed.
- Evidence of assessment of contract against requirements.
- Demonstration that all financial flows to pharmacies are in accordance with guidance.
Optometry
- Confirmation of number of enhanced services contracts the ICB has in place.
- Routine data detailing the number of new, terminated and varied contracts.
- Confirmation that the ICB has a process in place for managing risks and a mechanism for receiving and addressing feedback from NHSE, professional associations, providers or the general public.
Dentistry
- Evidence of monitoring contract performance and spending.
- Total contracts commissioned.
- Opening hours contracted, actual hours practice address, health service body status. Financial value and activity. Number of dental chairs in a practice.
- Value of new or recommissioned services equal to or more than decommissioned services
- Commissioned units of dental activity (UDAs) and units of orthodontic activity (UOAs) (and value of) and details of flexible commissioning arrangements in place.
- Evidence of avoiding making any double payments under any Dental Services Contracts and reducing the number of contracts which are under-delivering so that funds can be reallocated to meet local oral health needs.
- Number of providers that have received Discretionary Payments or Support.
Primary medical services
- Number of providers that have received Discretionary Payments or Support.
Domain 4 – Contractor/provider compliance and performance
The below table provides some examples of the types of data or information that could be provided to evidence assurance against this domain, in each contractor group. This list is not exhaustive.
Pharmaceutical services
- Evidence that a contract monitoring visit schedule is in place, covering at least 1-3% of contractors in the ICB area, selected in line with the Community Pharmacy Assurance Framework (CPAF) process.
- Committee minutes detailing actions taken to CPAF non-compliance, where relevant.
- MI detailing the activity undertaken to address non-compliance.
- Routine data on temporary closures (unplanned Closures) and aggregate changes to supplementary hours.
- Numbers of dispute resolution processes engaged in, remedial and breach notices issued, evidence of withholdings, suspensions and removals from the Pharmaceutical List.
- Evidence of action taken on Provider Activity Assurance where advised by the NHS Business Services Authority (NHSBSA).
- Evidence of actions taken to ensure the Data Security and Protection Toolkit (DSPT) is completed by contractors.
- Evidence of informing the NHSBSA.
- Oof all change of ownership and new pharmacy contracts to ensure this group are included in the CPAF process.
Optometry
- Routine data on quarterly PPV samples, including total value of reclaims.
- Routine data on percentage of contractors General Ophthalmic Services (GOS) assurance compliance and completion of GOS assurance action plans.
- Evidence of mechanisms for receiving and addressing feedback on its performance from NHS England, patients or contractors.
- Data on GOS complaints from patients, resolved by contractors.
- Routine data on numbers of, and reasons for remedial and breach notices.
- Committee minutes detailing decision making process for breach notices.
- Data/evidence of outcomes of GOS contractor complaints from patients, received by commissioners.
Dentistry
- Governance structure charts and appropriate meeting minutes.
- Remedial breach notices/satisfaction letters issued and followed up.
- Evidence of monitoring contract performance and spending.
- Evidence of achieving a reduction in the number of contract holders under-delivering.
- Evidence of collaborating with NHSBSA (dental assurance reviews) to monitor contract performance/ address patient safety concerns.
- Routine data on the total value of discretionary payments and the number of providers receiving the payments and rationale for these payments.
Primary medical services
- Routine data on the total value of discretionary payments and the number of providers receiving the payments.
- Routine data on number of contractual notices issued (and key themes).
- Status of annual contractual performance reviews.
- Data on response to CQC inspection and rating.
Annex 2 – Annual self-declaration form
Download a copy of the annual self-declaration form in Word format.
Version 5
Publication reference: PRN00303