Scope of the regime in relation to primary care services

Primary care services collectively refer to primary medical care, community pharmacy, primary dental care and primary eye care services. This annex is for relevant authorities arranging primary care services under the PSR and provides additional information about how the PSR is expected to be applied when selecting providers for the delivery of primary care services. It is advised that this annex is read alongside NHS England’s dedicated policy and guidance manuals, which support commissioners in the legal, safe and effective discharge of their primary care responsibilities.

Since 1 April 2023 all integrated care boards (ICBs) have assumed delegated responsibility for the commissioning of all primary care services.

Primary care services collectively refer to primary medical care, community pharmacy, primary dental care, and primary eye care services. The procurement of most primary care services is in scope of the PSR.

Primary care services are often commissioned on the basis of contracts, which do not have a fixed end date, and so run until terminated. These contracts are therefore not routinely rearranged by relevant authorities.

However, there will be situations where relevant authorities must select a new provider for a service; for example, when responding to planned or unplanned contract terminations or the expiration of time-limited contracts [such as Alternative Provider Medical Services (APMS) or Personal Dental Services (PDS) contracts], or when arranging new services (such as those to be delivered by new GP surgeries within a new estate or development). In these situations, relevant authority must follow the appropriate provider selection process and, where a range of contract types are available, determine which one best meets local population needs where a range of contract types are available.

As a general rule:

• new primary care services that involve a relevant authority selecting a provider, and where the number of providers available to patients is restricted by the relevant authority, must be arranged by following the most suitable provider process or the competitive process
• new primary care services that do not involve a relevant authority selecting a provider, and where the number of providers available to patients is not restricted by the relevant authority, must be arranged under direct award process B
• continuation of existing services where the relevant authority does not select the provider(s), and instead any provider that meets the minimum requirement(s) is offered a contract and placed on a list of providers for patients to choose from, must be awarded under direct award process B
• continuation of existing services where the current provider’s contract is coming to an end, the number of providers available to patients is limited by the relevant authority, the relevant authority wishes to continue with the existing provider and decides that the current provider is satisfying the existing contract and will likely satisfy the proposed contract to a sufficient standard (taking into account the key criteria and applying the basic selection criteria), and the proposed contract is not changing considerably, may be awarded under direct award process C
• modifications to existing contracts may be made in line with this statutory guidance (see contract modifications)

Primary medical care services

This section provides examples of how the regime may be applied when selecting providers for primary medical care services across 5 scenarios:

1. Continuation of existing contracts
2. modification of existing contracts
3. planned provider exit
4. sudden or unplanned changes to existing contracts
5. new and integrated services

1. Continuation of existing contracts

A GP practice has an existing General Medical Services (GMS) contract

This is a nationally negotiated contract, made under s84(2) of the 2006 Act on the terms set out under the National Health Service (General Medical Services Contracts) Regulations 2015. These contracts are open ended (except in certain circumstances where a temporary GMS contract may be used (urgent GP contracts) unless terminated by either the relevant authority or the provider.

The contract has already been awarded and it will continue to run on an ongoing basis and will not come to an end unless terminated. Therefore, no day-to-day ‘provider selection’ is taking place.

A GP practice has an existing Personal Medical Services (PMS) agreement

This is a local agreement between the relevant authority (the commissioner) and named members of a GP practice, made under s92 of the 2006 Act on the terms set out under the National Health Service (Personal Medical Services Agreements) Regulations 2015. Almost all these agreements are open ended unless terminated by either the relevant authority or the provider. In the case of a time-limited PMS agreements should be treated on the same basis as APMS contracts (see below).

Some PMS agreements include a right of return to a GMS contract where the signatory was previously a provider of essential services under a GMS contract.

The open-ended agreement has already been awarded and it will continue to run on an ongoing basis and will not come to an end unless terminated. Therefore, no day-to-day ‘provider selection’ is taking place.

A GP practice has an existing Alternative Provider Medical Services (APMS) contract

APMS means arrangements made under s83(2) of the 2006 Act on terms set out under Directions that are issued from time to time.

This contract is time-limited with the appointed provider and therefore a decision on recommissioning the service is needed periodically.

The relevant authority has the flexibility here to decide on the most suitable GP contract based on its assessment of the ongoing services needed in order to best meet the needs of patients and the understanding of the provider market.

The following options are available to relevant authorities when awarding a new contract (GMS, PMS or APMS), once the existing contract has come to an end:

• if the proposed contract is not changing considerably from the existing contract (for example, an APMS contract of similar scope and term) and the provider is satisfying the existing contract and will likely satisfy the proposed contract to a sufficient standard, then the relevant authority may award the contract using direct award process C
• if the proposed contract is changing considerably (e.g. replacing an APMS with a GMS contract would be considered a considerable change given its in perpetuity nature) or the relevant authority wants to seek new providers, then the relevant authority may award the contract using the most suitable provider processor the competitive process.

2. Modification of existing contracts

Merger of 2 or more GP practices leading to changes to existing contracts

Practice mergers may require major modifications to contracts. Some may be straightforward (for example, merger of GMS and GMS contracts), while others are likely to be more complex (for example, merger of GMS, APMS and PMS contracts). The relevant authority may need to decide whether to continue with an existing contract or to create a new contract.  

Practice mergers that result in the same services continuing, albeit held by updated bodies or sets of individuals, under one of the previously existing contracts, are permitted modifications under the regime. Therefore, there is no need to undertake a provider selection process. Relevant authorities should refer to the contract modifications section for further information about the processes that must be followed.

However, where practice mergers require material modifications to a contract, such as the locations from which services are delivered or the scope of services delivered, a new contract needs to be awarded. The most suitable provider process or the competitive process must be applied because the relevant authority is in effect commissioning a new service.

A sole practitioner or a partnership wishing to replace its contract with a new one, so that it is held by a body corporate

This type of contract modification is permitted under the regime providing the services do not changed. Therefore, there is no need to undertake a provider selection process. Relevant authorities should refer to the contract modifications section for further information about the processes that must be followed.

Substantial modifications to existing contracts

Examples of substantial modifications are adding a new branch surgery under a contract or introducing major changes to contract payment mechanisms. They may be permitted under the regime, but this will depend on the size and reason for the modification and the impact it has on the services delivered. Relevant authorities should refer to the contract modifications section for further information about the processes that must be followed.

A GP partnership changing its members

The contracting parties are changing but this does not result in changes to the services delivered, following the processes set out in the primary medical services policy and guidance manual (PGM) and as permitted under contract regulations. Relevant authorities should refer to the PGM for the required notices to effect a contractual change of members holding the contract.

This type of contract modification is permitted under the regime providing the services do not changed. Therefore, there is no need to undertake a provider selection process. Relevant authorities should refer to the contract modifications section of the statutory guidance for further information about the processes that must be followed.

A GP partnership changing members or dissolving, and the former partners disagree about who should take over the contract to deliver the services

Where a GP partnership has changed membership, refer to the Primary medical services policy and guidance manual (PGM) concerning the appropriate notices required to effect a contractual change of members holding the contract. If a partnership dissolves, the former partners may agree which partner(s) will continue to hold the contract. This type of contract modification is currently^{Note 2}permitted under the regime providing the services do not change.

If the former partners disagree about which  partner(s) will continue to hold the contract, commissioners may be able to decide which of the former partners it should continue with. This type of contract modification is currently permitted  under the regime providing the services do not change.

If the partnership dissolves, and there is (a) no agreement between all partners about which partner(s) will continue to hold the contract and (b) the commissioner is unable to identify a successor among the former partners, a new ‘selection’ decision is needed. A new contract must be awarded and for this the most suitable provider process or the competitive process must be followed.

Material modifications to existing APMS contracts

If the contracting arrangements are changing materially, then contract modification is not permitted under the regime.

Consequently, the relevant authority has a new ‘selection’ decision to make and must follow the most suitable provider process or the competitive process to select the provider(s) for the new service.

3. Planned provider exit

Planned provider exit from a GMS, PMS or APMS contract

In these situations, the decision for the relevant authority is either to disperse the patient list to the surrounding practice(s), in which case no provider selection takes place, or to select a new provider. There may be complex scenarios where part of the patient list is dispersed and the remaining ‘core’ list is subject to the selection of a new provider. 

If a new provider is being selected, then the most suitable provider process or the competitive process must be followed.

4. Sudden or unplanned changes to existing contracts

Sudden closure of an existing GMS, PMS or APMS contract holder

Examples are closure due to the death of a GP who is the sole contract holder or loss of Care Quality Commission (CQC) registration.

In these situations, the decision for the relevant authority is either to disperse the patient list to the surrounding practices, in which case no provider selection takes place, or to select a new provider – this may either be as a temporary contract or a longer-term solution. Again, complex scenarios requiring both list dispersal and the selection of a new provider may arise.

If a new provider is being selected, then the urgent provisions in the regime may be used to secure immediate needs, for example to establish caretaker arrangements. However, as this will only be a temporary arrangement, it must be reconsidered after a set period (the urgent circumstances section provides further information about proper application). To note, a temporary contract under The National Health Service (General Medical Services Contracts) Regulations 2015 can only be put in place for a maximum of 1 year.

Importantly, the most suitable provider process or the competitive process must be followed to establish a new long-term arrangement.

Urgent cover is needed for a service because a provider has opted out of providing it

Examples include:

• a provider leaves the market unexpectedly
• a directed or national enhanced service (that is, an enhanced service directed by the Secretary of State or by NHS England) needs rearranging rapidly due to a provider unexpectedly declining to participate

In these situations, the decision for the relevant authority is either to direct the patients to the surrounding practices, in which case no provider selection takes place, or to choose a new provider for the duration of the enhanced service offer, for example annually.

If a new provider is being selected, then the urgent provisions in the regime may be used to secure immediate needs, for example to establish caretaker arrangements. However, as this will be a temporary arrangement, it must be reconsidered after a set period (the urgent circumstances section provides further information about proper application). To note, a temporary (GMS, PMS or APMS) contract under The National Health Service (General Medical Services Contracts) Regulations 2015 can only be put in place for a maximum of 1 year.

Importantly, the most suitable provider process or the competitive process must be followed to establish a new long-term arrangement.

5. New and integrated services

Establishing a new GP service (using GMS, PMS or APMS contracts)

In this circumstance, a new provider is being selected for a new contract and so relevant authorities must follow the most suitable provider process or the competitive process.

Commissioners will need to determine which contract best meets their local population needs, noting that subsequent provider selection decisions will require consideration against the mandatory key criteria where they apply. The PSR does not direct how the key criteria are applied and it is for relevant authorities to determine the appropriate weighting for each one based on how they are arranging the service; this may vary according to whether the contract is for GMS, PMS or APMS.

Arranging a new service under a APMS contract

An example is arranging a new walk-in GP service within a hospital. This may be with a freestanding APMS contract located within the hospital, or a NHS trust or NHS foundation trust may contract for the business and either directly employ GPs or subcontract to GPs.

As a provider is being selected for a new service, relevant authorities must follow the most suitable provider process or the competitive process.

New mixed primary medical care and non-primary care services

An example is new integrated NHS 111 services. These services are usually set up under the NHS Standard Contract (with APMS ‘bolt-on’ schedule) and comprise primary medical care and urgent care services.

As a provider is being selected for a new service, relevant authorities must follow the most suitable provider process or the competitive process.

Commissioning local enhanced services or local incentive schemes

An example is GPs with specialist expertise (for example, in dermatology or vasectomies) carrying out ‘traditional’ secondary care healthcare services in primary care settings. These services may be carried out under a subcontract with an NHS trust or NHS foundation trust or may be directly commissioned from GPs.

As a provider is being selected for a new service, the relevant authority must follow the most suitable provider process or the competitive process.

Where the relevant authority is inviting all GP practices to provide a wider range of services in general practice or to provide their core general practice services at an enhanced level, then these services may be carried out under a contract modification.

If the members of a primary care network (PCN) are commissioned to deliver the services, then the relevant authority ‘commissions’ the PCN, but it is for the PCN (through its collaboration or network agreement structures) to determine how the practices within the PCN operate to deliver the services. PCNs are not legal entities and therefore they cannot hold a contract. This means that either a lead practice will hold all the contracts for the PCN or the relevant authority will hold a contract with each individual practice in the PCN, which then come together through a collaboration agreement. Some PCNs have established a company (or other corporate entity) to carry out services or other functions on its behalf. That company is a separate legal entity to the PCN and may be treated like any other potential provider when considering awarding a contract and selecting the appropriate contract award process.   

Where a PCN is to be commissioned, the relevant authority must follow the most suitable provider process or the competitive process to decide which PCN the services should be delivered by, but the regime is not applied when the PCN decides which practice should hold the contract or deliver the services as it is not a relevant authority and therefore not subject to the regime.

Commissioning a directed enhanced service that only a limited number of providers can provide to meet the needs of the population

Such services are usually secured via APMS contracts and in this circumstance a new provider is selected for a new contract. Therefore, the relevant authority must follow the most suitable provider process or the competitive process.

Where a directed enhanced service is or has been offered to all primary medical services providers, then the relevant authority may be able to use direct award process B if all the following apply:

• the number of providers is not restricted by the relevant authority as long as they meet the minimum criteria
• the relevant authority will offer contracts to all providers to which an award can be made because they meet all requirements in relation to the provision of the healthcare services to patients
• the relevant authority had arrangements in place to enable providers to express an interest in providing the healthcare services

Where the relevant authority restricts the choice of provider, for example through a Special Allocation Scheme (SAS), then the relevant authority cannot arrange the service under direct award process B. In this circumstance the relevant authority should follow either direct award process A or the most suitable provider process.

Establishment of a new integrated urgent care service (including out-of-hours service)

Such new contracts are largely set out under the NHS Standard Contract and comprise some primary medical care and some urgent care, taking referrals from NHS 111.

In these circumstances, a provider is being selected for a new service and so relevant authorities must follow the most suitable provider process or the competitive process.

A PCN takes on a new responsibility to provide or secure (subcontract) enhanced access to GP services

Some PCNs may choose to subcontract enhanced access services and they may continue to use the same providers.

The relevant authority must follow the most suitable provider process or the competitive process to decide which PCN the services should be delivered by.

PCNs are not legal entities and therefore they cannot hold a contract. This means that either a lead practice will hold all the contracts for the PCN or the relevant authority will hold a contract with each individual practice in the PCN, which then come together through a collaboration agreement. Some PCNs have established a company (or other corporate entity) to carry out services or other functions on its behalf. That company is a separate legal entity to the PCN and may be treated like any other potential provider when considering awarding a contract and selecting the appropriate contract award process.   

The regime does not apply to the PCN deciding which practice should hold the contract or deliver the service. However, the PCN’s lead provider, if that is the agreed model, may subcontract further (for example, to a GP federation outside the PCN). In these situations, the PCN must comply with the controls on subcontracting in the original commissioning contract it received.

but the regime is not applied when the PCN decides which practice should hold the contract or deliver the services as it is not a relevant authority and therefore not subject to the regime.

Primary dental care services

This section provides examples of how the regime may be applied to primary dental care service contracts across 2 scenarios:

1. continuation of existing contracts
2. sudden or unplanned changes to existing contracts

To note, community dental services are not classified as part of primary dental services under the 2006 Act. While primary dental services are commissioned under s99 of the 2006 Act, community dental services are commissioned under s3B(1)(a) of the 2006 Act and are “dental services of a prescribed description”. However, community dental services are in scope of the regime, because the regime applies to “all forms of healthcare provided for individuals”.

1. Continuation of existing contracts

A relevant authority has an existing General Dental Services (GDS) contract with a provider

This is a permanent nationally negotiated contract made under s28K of the National Health Service Act 1977 or s100 of the 2006 Act on the terms set out under the National Health Service (General Dental Services Contracts) Regulations 2005, unless terminated by either the relevant authority or the provider. The contract may be renegotiated or updated from time to time, but the service does not significantly change.

The contract has already been awarded and it will continue to run on an ongoing basis until terminated. Therefore, no day-to-day ‘provider selection’ is taking place.

A relevant authority has an existing Personal Dental Services (PDS) agreement with a provider

This is a contract that is negotiated under s28C of the National Health Service Act 1977 or s107 of the 2006 Act on the terms set out under the National Health Service (Personal Dental Services Agreements) Regulations 2005.

PDS agreements can be used to arrange mandatory services, specialist services such as sedation, or domiciliary services. They are generally time limited and normally reviewed around every 5 years.

PDS agreements are negotiated with qualifying individuals and can end (and thus need to be renewed) if these individuals leave or change, if the contract allows individuals a right to return to a GDS contract or following termination.

If a PDS agreement ends and needs to be renewed and the relevant authority restricts the providers available to patients, then the relevant authority may award a contract :

• using direct award process C providing the proposed contract is not considerably different from the existing contract and the relevant authority is satisfied that the existing provider is satisfying the existing contract and will likely satisfy the proposed contract to a sufficient standard
• using the most suitable provider process or the competitive process if the proposed contract is considerably different from the existing contract or the relevant authority wants to seek new providers

2. Sudden or unplanned changes to existing contracts

Sudden closure of an existing GDS or PDS contract holder

An example is sudden closure due to the retirement or death of a dentist who is the sole contract holder.

In these situations, the decision for the relevant authority is either to disperse activity to the surrounding dental practices, in which case no provider selection takes place, or to choose a new provider – to provide either temporary cover or as a permanent long-term solution.

If a new provider must be appointed immediately, then the urgent provisions in the regime may be used to secure immediate needs, for example to establish caretaker arrangements. However, as this will be a temporary arrangement, provider selection must subsequently take place to establish a new permanent arrangement. For this the relevant authority may use the most suitable provider process or the competitive process if the number of providers available to patients is restricted by the relevant authority.

Pharmaceutical services

The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 and The Pharmaceutical Services (Advanced and Enhanced Services) (England) Directions 2013 set out the contracting arrangements specific to community pharmaceutical services.

Essential and advanced pharmaceutical services do not come under the regime. However, other health services provided by pharmacies, such as enhanced pharmaceutical services, may be in scope including:

• services commissioned directly from pharmacies under the NHS Standard Contract, such as an anticoagulant service
• local enhanced services, such as vaccination programmes

Where new or existing services that fall in scope of the regime are being arranged and the number of providers is not restricted by the relevant authority, the relevant authority must use direct award process B.

When the commissioning of new services falls in scope (such as the examples above) and the number of providers is restricted by the relevant authority, then the relevant authority may use the most suitable provider process or the competitive process to establish these. This may be appropriate in cases where the provider is being selected based on its ability to provide a specific service – that is, its geographical location for an out-of-hours service.

To continue with existing arrangements (that is, to award a new contract to the existing provider where its current contract is ending), using direct award process C may be an option where direct award process B does not apply, providing that the services are not changing considerably (see direct award process C) and the relevant authority is satisfied that the existing provider is satisfying the existing contract and will likely satisfy the proposed contract to a sufficient standard.

Primary eye care services

The type and provision of primary eye care services is set out in the General Ophthalmic Services Contracts Regulations 2008.

The procurement of primary eye care services is in scope of the regime. 3 types of primary eye care services may be commissioned:

1. mandatory services
2. additional services
3. enhanced services

1. Mandatory services

Mandatory services, which include NHS sight testing and the provision of NHS optical vouchers, must be commissioned by the NHS in all areas of England, under the national General Ophthalmic Mandatory Services Contract. Any provider that applies and meets the required criteria may provide these services, meaning that the relevant authority does not limit the providers available to patients.

Therefore, contracts must be awarded under direct award process B, on condition that patients have a choice of providers and the number of providers from which patients can choose is not restricted by the relevant authority.

2. Additional services

Additional services (for example, mobile NHS sight testing) must be commissioned in all areas of England, under the national General Ophthalmic Additional Services Contract. Any provider that applies and meets the required criteria may provide these services, meaning that the relevant authority does not limit the providers available to patients.

Therefore, contracts must be awarded under direct award process B, on condition that patients have a choice of providers and the number of providers from which patients can choose is not restricted by the relevant authority.

3. Enhanced services

Enhanced services are extended ophthalmic services, including but not limited to:

• minor eye conditions services
• urgent eye care services
• referral refinement
• stable glaucoma monitoring
• post cataract care

Relevant authorities may choose to commission these services, under the NHS Standard Contract, to meet local needs, fit with local eye care development plans and reduce pressure on secondary care ophthalmology services. Contracts for enhanced ophthalmic services are generally awarded to selected providers as required to meet system requirements, rather than to all potential providers, and as such they cannot be awarded under direct award process B.

Therefore, if a contract for enhanced services needs to be awarded and the relevant authority is choosing and therefore restricting the particular provider or group of providers available to patients, then it may:

• award the contract to an existing provider using direct award process C, providing the existing contract is ending, the proposed contract is not changing considerably from the existing contract, and it is satisfied that the existing provider is satisfying the contract and will likely satisfy the proposed contract to a sufficient standard
• follow the most suitable provider process or the competitive process if the proposed contract is changing considerably from the existing contract or it wants to seek new providers