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Published 20 September 2017
The development of new models of care requires traditional boundaries between health services to be removed in favour of a more integrated provider landscape. With no new legislative framework to bridge those boundaries, the contractual arrangements required to do so may be novel and complex. NHS England ("NHSE") and NHS Improvement ("NHSI") have recognised this and following initial guidance on the Integrated Support and Assurance Process ("ISAP") published in November 2016, final guidance has now been published: Integrated Support and Assurance Process (NHS England).
The ISAP has been developed to mitigate the inevitable risks involved with the development of complex contracts so far as reasonably possible. Although risks will not be eliminated, a rating system will aim to ensure that the proposals presented represent a solution which is in the interests of patients.
Given the ISAP's focus on appraisal of risk, it is made clear that the process will examine the extent to which the governing body of the commissioner (and potentially the boards of other organisations involved) have examined the proposals at key stages.
The ISAP will apply in circumstances where a commissioner is proposing to procure new arrangements for existing services or the re-procurement of a complex contract. Additionally, the ISAP will also apply to providers who gain preferred bidder status, where it will act as a safeguard to examine the bidder's ability to assume the risks associated with the contract.
The ISAP will draw on the existing processes of NHSE including the CCG Improvement and Assessment Framework as well as NHSI's methods of risk evaluation. If a transaction review is required for an NHS Trust or NHS Foundation Trust it will form part of the ISAP process in accordance with the Single Oversight Framework.
The definition of a complex contract, and therefore when the ISAP may apply, is subject to the discretion of NHSE and NHSI, so as explained below, commissioners should engage with NHSE and NHSI at an early stage in order to determine whether the ISAP will apply in any particular case.
It is expected that new models of care involving cross-service integration along a care pathway, multispecialty community providers, primary and acute care systems and accountable care organisations will be subject to the ISAP due to the need for risk sharing arrangements. Services which involve complex delivery and/or payment mechanisms may also be subject to the ISAP.
If a contract is considered complex, whether or not the ISAP will apply is determined based on four factors: relative contract value (not applicable for specialised services), contract duration, commissioner quality and degree of performance-based income.
The ISAP process consists of four stages, as outlined below, with the minimum expected procurement timeline to be 15 – 18 months. This staged process involves significant engagement including "Key Lines of Enquiry" ("KLOE") designed to establish a risk profile and numerous checks and balances. The KLOEs are defined in detail in the ISAP. There are a number of KLOEs that require specific legal input to evidence compliance:
Each checkpoint requires a summary of key legal issues and risks to be provided as part of the evidence gathering process. Confirmation is also required as to whether or not a commissioner has followed advice, and if not, how the risks will be managed.
During the review process a series of ISAP ratings (red, amber and green) will be used to determine whether or not expectations have been met.
Ultimately, the aim of the ISAP is to enable a joined up approach between NHSE and NHSI in scrutinising the risks of a project involving novel and/or complex contracts.
For advice and guidance on the ISAP, please contact Hamza Drabu, Charlotte Burnett, Alistair Robertson or Graham Lawrence.
London - Walbrook
+44 (0)20 7894 6411
+44 (0)113 251 4785
+44 (0)20 7894 6020
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