The new statutory regulations for CCG commissioning will mean that lawyers can overrule clinicians, doctors and legal experts have warned.

While a debate and vote on the new regulations in the House of Lords are scheduled for 24 April, campaigners have warned that they will lead inevitably to a full privatisation of the NHS.

Explicitly intended to ensure that CCGs obey the principles of the Health and Social Care Act, the new regulations make it possible for private providers to challenge commissioning decisions on the basis of business law.

The Department of Health, which revised the regulations following protests from the medical professions, insists that CCGs will have the authority to decide which services are put out to tender.

However, legal experts have stated that the decisions of CCGs will be vulnerable to legal challenges from private providers, since the ‘any qualified provider’ concept places commissioning within a business law framework.

Lord Hunt (pictured), Deputy Leader of the Opposition in the House of Lords, has tabled a ‘fatal motion’ against the new commissioning regulations that could temporarily block its passage into law.

Crossbench peer Lord Owen accused the Government of using “specious grounds of urgency” to drive through legislation that contradicts its own principle of ensuring ‘clinically led commissioning’.

According to Dr Kambiz Boomla, a GP in East London, “These regulations are likely to be the death of clinically led commissioning, and the birth of lawyer led commissioning.”

Clare Gerada, Chair of the Royal College of GPs, similarly warned that the new regulations will “remove the legal framework” for a “universal” and “democratically accountable” NHS.

A Labour Government will rebuild the NHS as “a national, planned, collaborative system”, according to Shadow Health Secretary Andy Burnham.

In a preview of his party conference speech, Burnham promised to end the ‘any qualified provider’ (AQP) policy, which he said is now causing wholesale NHS privatisation.

More controversially, he outlined plans to have local authorities lead NHS commissioning and NHS hospitals provide social and mental health care.

Pledging a return to the NHS as ‘preferred provider’ of services, he said the private and voluntary sectors would “play a supporting role to a publicly owned, publicly accountable NHS”.

Burnham noted, from information about NHS tenders obtained through freedom of information requests, that the AQP rules now in operation were leading to rapid privatisation of many NHS services.

“This week the AQP contracts are being signed with private companies,” he said. “It is very difficult to find out what is going on. Who they are, how much is being spent. They cite commercial confidentiality but that is not good enough.”

In particular, he argued, hospitals reserving up to 49% of their beds for private patients from 1 October will “damage the character and culture” of the NHS.

While Labour did not intend to exclude the private sector from NHS service provision, he stated, it would remove the new “competitive structure” that hospitals and providers “have to work within”.

To achieve this, it would replace the CCGs with a commissioning system led by local government – retaining local control but removing the commercial element.

In addition, instead of reducing the role of hospitals, Labour would involve them in providing social and mental health care for the most vulnerable people.

Labour leader Ed Milliband has already pledged to repeal the Health and Social Care Act.

Does the CCG guidance signal a return to top-down control?

The Department of Health draft document listing the requirements for commissioners, Securing best value for NHS patients, proposes to make law what had previously been guidance in codes of practice for PCTs and SHAs. What are the implications for local commissioners of “choice and competition” becoming mandatory, with Monitor serving as a watchdog to seek out “anti-competitive” decisions? Is this an attempt to disguise top-down control of commissioning and prescribe the choices of CCGs?

Value-based commissioning
The consultation document states the case for a statutory commissioning framework in robust terms. Local commissioners are facing unprecedented challenges in terms of both demand and supply: the ageing population and the growing prevalence of long-term conditions combined with the NHS “facing one of the tightest funding settlements in its history”. As a result, their primary task is “to secure best value from limited resources”.

The question of value is therefore crucial for CCGs and other commissioners. The draft guidance implies that commissioners cannot be trusted to define value for themselves. It says they need “flexibility” to meet the challenges of commissioning through various methods: “managing providers’ performance, extending and varying contracts, widening choice of qualified provider, and tendering”. However, it argues, commissioners in the past have sometimes restricted themselves by using “bureaucratic processes” and “disproportionate or inappropriate criteria”. It is therefore necessary for external controls to ensure that they carry out “an objective assessment of different options and a rigorous evaluation of different providers”, which “has not always been the case” in the past.

The DH states candidly that “we will not be able to enforce non-statutory, administrative rules in the reformed system, where commissioners and other organisations have greater autonomy… We need to put the rules on a statutory footing so that they are binding on the new commissioning organisations.”

In other words, what had been top-down guidance needs to become law in order to prevent CCGs from using their “autonomy” incorrectly. By “flexibility” the draft document means readiness to engage with the private sector, using assessment criteria that are not chosen by the commissioner. So the proposed legislation is intended to shape the emerging healthcare market.

Choice and competition
The proposed laws for commissioning are based on the existing principles and rules of PCTs. However, the DH places special emphasis on the need to protect competition – which it clearly views as an area where CCG practice may conflict with the spirit of the NHS reforms. The draft document thus reiterates the principles of tendering and ‘any qualified provider’ before stating its aim “to establish a requirement prohibiting commissioners from treating a provider more or less favourably than others, in particular on the basis of ownership, for example [whether] it is a public, voluntary or private organisation”.

A major proposed rule is: “Commissioners must secure services from providers who are best capable of meeting patients’ needs and deliver best value for money, using choice and competition, where appropriate, as a means to improving quality and efficiency in the provision of services.”

The draft document restates the principles of patient choice laid out in the NHS Constitution. These include the right “to choose any provider in England for a first consultant-led appointment for most elective services” and the right “to request that a commissioner takes all reasonable steps to offer an alternative provider when waiting over maximum waiting times for treatment”. In addition, the DH notes, “the Government intends to increase the choices that patients have”.

Choice and competition are therefore key mechanisms by which “quality and efficiency” can be achieved – with the latter defined not by CCGs, but by an external framework. To back this up, CCGs will need to “act transparently” and “maintain appropriate records” of the decision-making process.

Beware of the watchdog
Making these rules statutory raises the question of how they will be enforced. The answer is Monitor. According to the draft guidance, the economic regulator will be responsible for “preventing anti-competitive conduct” when it is “against patients’ interests”.

Monitor will not engage proactively with commissioners to achieve this, but neither does it have to wait for a formal complaint before intervening – a provision explicitly designed to reduce the need for ‘whistle-blowing’ by providers, which can damage their ongoing relationships with commissioners.

It is proposed that commissioners “shall not enter into any agreement or engage in any conduct which has the object or effect of preventing, restricting or distorting competition in the provision of healthcare services,” unless it is “indispensable to the attainment of the intended benefits for people who use these services”.

These rules avoid stating that Monitor will ‘enforce’ competition, a principle of the original Health and Social Care Bill that was removed following the ‘listening exercise’. By linking the role to patients’ interests, the document underlines its own statement that competition is a means to the end of improved patient care.

Details of how Monitor will enforce these rules are forthcoming, but the document makes it clear that the regulator will report breaches to the DH.

Laying down the law
While it is clearly concerned with managing those CCGs that try to resist the creation of a healthcare market at local commissioning level, the draft guidance also seeks to manage any conflicts of interest that could expose the system to criticism. The final section of the draft guidance states that when a conflict of interests arises, it must be managed “effectively and transparently” by the commissioner. In other words, where it cannot prevent conflicts of interest, the DH seeks to limit the harm they can do.

The most obvious source of such conflict, where a CCG might commission services from a secondary care provider that is represented on its board, is already prevented by the existing rules governing the formation of CCG boards. However, CCGs have been critical of this restriction, since foundation trusts have no financial motive for releasing clinicans to serve on a CCG board where the CCG is not a customer of the trust. The establishment of a healthcare market means that clinical and commercial priorities are always in a dynamic tension: conflicts of interest are a normal symptom of that tension.

Essentially, the draft guidance proposes a model that brings the legal framework of the NHS much closer to that of company law. Legal and financial consultants will have an important role in local commissioning, on both sides: the commissioners and the providers. That classic soundbite of corporate transactions, “Your people will talk to my people”, is likely to become central to NHS service procurement. And as the draft document clearly states, the private and voluntary sectors are likely to be major players in NHS service provision.

The contentious question is: will these rules influence the commissioning decisions of CCGs? To some extent, by laying down “objective” and mandatory criteria for decision-making, they will. If a provider meets the DH’s criteria for quality and efficiency, the CCG will have to give them the contract regardless of other factors such as precedent, continuity or local culture. How providers and their legal teams exploit this framework will impact powerfully on the freedom of choice that local commissioners have.  

The draft commissioning guidelines signal a decisive shift in the culture of the NHS towards a competitive and company-based model. The use of law to enforce the rules of engagement might be seen as a disguised form of top-down management – and is undoubtedly intended to ensure that the NHS reforms are not blunted by rebel CCGs that try to perpetuate old relationships. But more importantly, it is an attempt to change the culture of the NHS by taking it into a legal framework modelled on the private sector. For the pharmaceutical industry, therefore, engaging with the new commissioners will be like looking into a mirror.

A new Department of Health programme to ensure ‘quality and choice’ in social care will help to ensure that local authorities make a full range of providers available to service users.

The Developing Care Markets for Quality and Choice (DCMQC) programme backs up the draft Care and Support Bill (published in July), which requires local authorities to engage with private sector providers.

The DCMQC programme will help local authorities to facilitate local social care markets through Market Position Statements that inform providers about the services that are required.

The programme’s key priorities are choice (in terms of how personal care budgets are spent) and quality (in terms of providing “what people want”).

Care and Support Minister Norman Lamb said: “People deserve a high quality care service that meets their needs. Everyone’s needs are different. This new programme will increase choice in the care services provided to them.

“We want to improve the care services already in place by giving local authorities the skills to work together with their care providers and anticipate future priorities, pressures and challenges in order to tailor care for their communities.”

The programme and the accompanying legislation parallel the steps being taken to ensure that CCGs obey the ‘any qualified provider’ rules.

Local authorities will be required to publish Market Position Statements that shape the local social care market by setting out current and future demand trends, stating the desired outcomes and helping providers to update their service models.

Private health providers are set to take a fifth (£20bn) of the NHS market by 2020, according to corporate finance consultant Catalyst.

CCG commissioning and the new ‘any qualified provider’ rules, combined with the shift to community-based care, will greatly increase the opportunities for the private sector, the Catalyst report says.

Catalyst predicts a major increase in M&A activity within private healthcare, with growing interest from overseas investors in NHS assets and businesses from other sectors seeking to enter the market.

Justin Crowther, Catalyst’s Director and co-author of the report, said that NHS commissioners “are increasingly using the skills and capital of the private sector” – for example, “to turn around underperforming hospitals, operate GP surgeries, deliver community services or create centres of excellence in areas such as pathology”.

The report points to the “landmark contracts” recently awarded to Circle, Virgin Care and Serco as a sign of the growing trend.

In particular, it notes the growing opportunities for private sector providers of primary and secondary care, accelerated by “the removal of barriers” through the new ‘any qualified provider’ rules.

Catalyst also predicts that the shift of healthcare to community settings will open up £2bn of business for the private health sector by 2020, while commissioning support services will create another £1.3bn of opportunities.

In all, it predicts that private health providers will command £20bn of the NHS market – 20% of the whole – by 2020.

The Department of Health (DH) has warned that the new commissioning arrangements may force existing local HIV services to force down.

Responsibility for sexual health services will transfer to local government and be put out to competitive tender, but responsibility for HIV services will transfer to the NHS Commissioning Board.

Consequently, HIV services that are currently provided as part of genito-urinary medicine (GUM) or sexual and reproductive health (SRH) services may cease to be “viable”, the DH says.

Because GUM services will be subject to ‘any qualified provider’ rules (soon to become laws), preserving service arrangements that integrate GUM and HIV services will be ‘anti-competitive’ and therefore illegal.

This poses a threat in particular to small-scale local HIV services based in existing GUM or SRH clinics.

NHS Deputy Chief Executive David Flory (pictured) explained in a letter to NHS trusts: “Where the tender exercise results in a new provider for GUM and SRH services, an unintended outcome may be that the NHS Trusts that previously provided joint GUM and HIV treatment services may no longer find it viable to continue to provide HIV treatment services independently from GUM.”

As a result, Flory said, many HIV patients may need to have their services transferred to a new provider. The DH’s priority was to avoid “fragmentation” of services, he said.

Despite the DH’s claim that the closure of local HIV services was “an unintended outcome”, the British HIV Association and the House of Lords Select Committee on HIV warned last year that it was likely.

The NHS operating framework provides the blueprint for the NHS in England. Pf examines its objectives around quality and reform.

The Operating Framework for the NHS in England 2012/13 is an important document for UK medical sales professionals. It outlines the national priorities, system levers and mechanisms that the NHS in England must focus on to improve patient care. The strategic framework details expectations for the NHS’ ongoing efficiency challenge and the transition to the new commissioning and management system. It sets out the planning, performance and financial requirements for NHS organisations and the basis on which they will be held to account. With QIPP imperatives at the heart of the strategy, proactive pharmaceutical companies that can demonstrate an ability to help NHS customers deliver efficiencies and improve qualities in areas of national priority will be best placed to succeed.

The Framework identifies four key themes for NHS organisations in 2012/13:

1. Putting patients at the centre of decision making in preparing for an outcomes approach to service delivery
2. Completing the final year of transition to the new system
3. Accelerating the delivery of the QIPP challenge
4. Maintaining a strong grip on services and financial performance.

Quality - a focus on outcomes

The Operating Framework says that the NHS’ model of delivery must be overhauled in 2012/13 to become a system driven by quality and outcomes. It identifies the Outcomes Framework as the catalyst for this – with its focus on clinical outcomes and the reduction of health inequalities driving changes in culture, behaviour and service delivery. The Outcomes Framework sets out the improvements against which the NHS
Commissioning Board will be held to account from 2013/14.

These measurements are set out within five domains:

Domain 1: preventing people from dying prematurely.

Domain 2: enhancing quality of life for people with long-term conditions.

Domain 3: helping people recover from episodes of ill health or following injury.

Domain 4: ensuring people have a positive experience of care.

Domain 5: treating and caring for people in a safe environment and protecting them from avoidable harm.

The Operating Framework details a range of indicators for each domain, all of which are explored in the NHS Outcomes Framework. These will be supported by NICE quality standards, which provide definitions of what high-quality care should look like for a particular pathway of care. The document also advises NHS organisations to meet the service specific outcomes strategies that have already been published in areas such as mental health, cancer, COPD, asthma and long-term conditions.

Each domain in the NHS Outcomes Framework has a strong relevance to pharma, whether through the development of medicines to treat disease in priority areas, or via collaborative service design to move care closer to patients’ homes and reduce hospital admissions. Organisations that are able to show how their innovations can improve a care pathway or be used as part of a redesigned service will enjoy
more positive NHS engagement.

The Operating Framework identifies dementia and care of older people as a key priority, and sets clear goals to integrate health and social care. It also highlights examples of initiatives where NHS organisations have successfully improved services in line with each of the four key elements of QIPP; quality, innovation, productivity and prevention.

Reform - the transition blueprint

The Operating Framework outlines the key milestones for the reorganisation of the NHS. Whilst the headlines are widely known, it is interesting to track current progress against a timetable that was set out many months before the Health & Social Care Act was passed. The Framework notes that by
the end of 2012/13:

“The NHS will have transformed the commissioning landscape into one focused on local clinical decision
making, with the development and authorisation of CCGs, assisted by commissioning support vehicles and overseen by the NHS Commissioning Board. Local authorities will take the lead role in public health, alongside the new Public Health England. Central to the new system will be the establishment of Health & Wellbeing Boards (HWB), who will provide local systems leadership across health, social care and public health. Alongside this, developments will continue to the provider landscape, through the extension of Any Qualified Provider (AQP), progress with the NHS Foundation Trust (FT) pipeline and the establishment of the new NHS Trust Development Authority.”

Key 2012/13 objectives in the transition are as follows:

• PCTs and SHAs will remain statutory organisations until April 2013. They will be held to account on delivering performance and support the development of new organisations for clinical leadership. Clinical Senates and networks will be established
• PCTs will support CCG authorisation and the transition of power before March 2013
• HWBs will be established in shadow format, becoming statutorily operational from April 2013. They will act as the local system leader through JSNA and HWB Strategies
• CCGs must be coterminous with a single HWB ‘as far as possible’
• CCGs must: play an active role in planning and budgeting, develop relationships with local partners
  including social care, deliver their share of the QIPP agenda and identify how to secure commissioning support services in line with their running cost allowance
• Public Health England will become a statutory executive agency from April 2013
• NHS Trusts are expected to achieve FT status by April 2014
• PCT clusters should start to offer patients choice of AQP in at least three services that are local priorities. There should be a presumption of choice for most services from 2013/14.

The year 2012/13 marks the last phase of the transition to the new NHS for England, and the next NHS Operating Framework sets out the template for this. Alan Jones looks into its implications for pharma.

As we approach the next NHS financial year, it is time to examine what the Department of Health expects of the NHS and what this might mean for pharma. The new Operating Framework for the NHS in England 2012/13 is rather dry, but nevertheless is one of the ’must-read’ documents as you start to prepare your business plans for the year ahead. We pick out some highlights here.

First off, the document sets out the business and planning arrangements for the NHS and describes the national priorities and the ‘system levers and enablers’ needed for NHS organisations to improve the quality of services provided, while both delivering transformational change and maintaining financial stability (aka ‘grip’). It also sets out the practical steps that need to be taken to carry the NHS through a stable transition over the coming year as it moves towards its new structures.

There is much about transforming service delivery and the major shift to a more outcomes-focused approach. The main chapters are on quality, the reform process, finance and ‘business rules’, and planning and accountability. Note that this will be the final Operating Framework for the current delivery system of PCTs and SHAs, and probably the last one of its kind, since this is the final year of transition to the new system.

Outcomes to the fore
This document is rather dry, because there is now a lot of other ‘sexy’ health policy stuff around in documents such as those on clinical commissioning group (CCG) authorisation, clinical commissioning support and the more recent 2012/13 NHS Outcomes Framework – again, all important documents to peruse, and with major implications for pharma.

Pinched from the latest Outcomes Framework are new national performance measures laid out according to the various domains, described in detail in the Annex to the document. For example, from ‘Domain 2: Enhancing quality of life for people with long-term conditions’ there are measures around early intervention (mental health measures) and unplanned hospitalisation in diabetes patients (long-term condition measures). By 2013/14 both the NHS Commissioning Board (NHSCB) and the CCGs will be held to account for such outcomes delivery, and will be expected to publish data on achievement against the indicators in the Outcomes Framework at a local level. This will be linked to the proposals for the new Commissioning Outcomes Framework (COF), which is due to go live in 2013/14.

Some of the COF indicators will be based on NICE quality standards, and as with the Outcomes Framework there will be a particular focus on clinical effectiveness. Also stressed is the link of COF not only to the NHS Outcomes Framework but also to the Public Health and Adult Social Care Outcomes Frameworks. Readers might want to examine these closely to see where they overlap with shared indicators – this is particularly relevant with the new drive towards better integration of care in long-term conditions such as schizophrenia.

QIPP and innovation
The NHS Operating Framework spends a fair amount of time going through some of the outcome measures or proxies in the five domains of the NHS Outcomes Framework – all hugely relevant to pharma. CHD/CVD, diabetes, mental health, cancer, asthma, COPD, epilepsy and venous thrombolembolism are all in the mix. With payers no longer wanting to be sold ‘pills and gadgets’ but solutions that unlock quality and value, now is the time for brand managers to finally step up to the NHS mark.

Early diagnosis and treatment are stressed, as are NICE quality standards. There is to be a renewed push on implementation of the national dementia strategy, and commissioners need to ensure that providers are compliant with NICE quality standards and that diagnosis rates improve.

Interestingly, there are some reform indicators for the first time – e.g. the percentage authorisation of CCGs. NHS and NHSCB Chief Executive Sir David Nicholson points out in his foreword to the document that this is the second year of the quality and productivity challenge, and he emphasises the need for the NHS response to this challenge to accelerate.

QIPP gets considerable coverage, with examples of good practice being given and available resources noted – such as the NHS Evidence website and the Atlas of Variation, with Volume 2 of the latter now published with prescribing maps. Sir David wants more rapid diffusion of good practice (industry should be able to help here), and the new Innovation Review sets out specific measures to achieve this. Service change and clinical service redesign are seen as key, and again this is something that pharma must factor into its forward plans.

New customers galore
2012/13 is seen by the Government as a critical year for the building of the new NHS architecture and delivery system. The CCGs will have to focus on improving care of long-term conditions; clinical networks and clinical senates will be established; and the Health and Wellbeing Boards plus the NHS Commissioning Board will go onstream. There will be more NHS Foundation Trusts, though it is expected that around 20 hospitals will not make the grade. There will be continued rollout of Any Qualified Providers plus the new commissioning support organisations, and there is mention of the newly-integrated organisations that have arisen via the Transforming Community Services programme.

So there are many new industry customer groups since this time last year! Note that the first time, the document states that the Health and Wellbeing Boards should be the ‘local systems leader’ with the key role of integrating local commissioning and overseeing a clear local strategy across the three separate systems of the NHS, public health and social care through joint strategic needs assessments (JSNAs). Please remember that local government is where the director of public health will be based in future, which is another good reason to put local authorities on your radar…

CQUIN and PbR
The document also proposes new national CQUIN goals, and the amount that providers can earn goes up to 2.5% of income. It is suggested that they may want to use the measures of the Innovation Review to help them set up such schemes. Commissioners must share agreed schemes on the NHS Institute website, and if you have not visited this site there is a real treasure trove of local schemes there. Some of these case studies could usefully be shared with customers. Click here for further information.

Local CQUIN schemes that are developing will need to be watched. And watch out too for developments within PbR in 2012/13, aimed at improving the links with quality of care, driving integration and incentivising the implementation of QIPP. That means expanding best practice tariffs, incentivising the performance of procedures in a less acute setting, pathway and mental health tariffs, and both chemotherapy and HIV joining the PbR club.

Clinical Commissioning Groups
Finally, note that CCGs are expected to be given £25 per head of population to be spent on management costs. This is before any entitlement to a COF ‘quality premium’. This sum is at the lower end of the expected range for the running cost allowance, and probably places the future of some of the smaller CCGs in doubt. Indeed, some CCG mergers have already begun. Through the coming year, folk will need to track the authorisation (or not) of each CGG, as this again is essential key account management stuff!

CCGs will also be thinking now about commissioning support and whether or not they need external support. This must be highly relevant to the pharma account management strategies beginning to take shape for the new ‘payers’, as well as the folk in head office considering new ‘support offerings’. Note that some aspects of medicines management also seem to be in the mix, and some of these providers could well be private companies.

Wrapping up
So there we are: another outline sketch of the key annual NHS business planning document and the year ahead. This is all key need-to-know stuff regarding the future new customers of pharma. With an acceleration of new customer groups springing up, industry account managers will have a lot to think about. The onward development of the CCGs particularly needs to be tracked, as does the commissioning support system being proposed. The development of the NHS Commissioning Board will also need to be watched, as it will be a brand new and critically important national account. It will, for example, have a ‘medicines optimisation’ role. Who will be the gatekeeper(s) in head office?

As the journey’s end draws near, the NHS at the end of 2012/13 will look and feel very different to the NHS at the beginning of the year. Are you getting ready for the final transition?

Alan Jones is an occasional contributor to Pf. He commentates and presents widely on the ongoing reform within the NHS and its implications for pharma and is a consultant to Wellards. An independent healthcare policy analyst, adviser and NHS trainer and mentor, he can be contacted here.

As the reforms continue to gather pace, Thoreya Swage outlines the schedule for the introduction of Any Qualified Providers and what they’ll need to do to be selected by the DH.

Successive governments of all colours have tried in recent years to shake up the healthcare system in the UK, with England probably being subject to the greatest number of the changes. A minor but key element of these changes has been various attempts to expand the healthcare market to include the private or independent sector. This widening of the door started in earnest with the deployment of the waiting list initiative in the 1990s by using the spare capacity of independent hospitals to reduce the queues of elective procedures that had built up in the NHS. The baton was then taken up by the heady days of the Independent Sector Treatment Programme with the last administration. Here, the range of work done by private providers expanded to diagnostic procedures and screening programmes, as well as the construction of bespoke independent hospitals to take on more hip, knee and cataract operations from the NHS.

It was at this stage that the concept of choice for patients to go to the healthcare institution they desired for treatment or diagnostic procedures started to take off, with some of those choices being the independent sector. This idea of an ‘any willing provider’ began to take shape, with NHS care being delivered by any appropriate healthcare body so long as it had reached identified quality and safety standards. However, with the recent change of government this initiative began to cool under external political pressure, and this all seemed set to fade
away.

What is a qualified provider?

Despite this opposition the Government has continued to plough on with this policy, calling it this time ‘any qualified provider’. In July of this year, the DH in England issued ‘operational guidance’ to the NHS
providing further details to PCT clusters and the emerging Clinical Commissioning Groups (CCGs) – the renamed GP consortia. This policy has come under the guise of improving the quality of care by widening patient choice for specific services.

The intention is to permit a patient to choose from a list of qualified providers when they require a referral for a specific community or mental health service. An ‘any qualified provider’ (AQP) is a healthcare organisation that meets the quality, prices and contractual obligations for NHS services. This process, as we have already seen, is in place for elective care.

The guidance states that the implementation of AQP will be conducted in phases from April next year. However, some work needs to have been done before that. PCT clusters and their associated Clinical Commissioning Groups need to have already decided (by October) which community or mental health services they wish to identify for the implementation of AQP locally, so that their patients can begin to have access to that care between April and September next year. At least three or more services from the following list drawn up by the DH, in conjunction with patient groups, should have been identified by PCTs and CCGs:

• Musculo-skeletal services (neck and back pain)
• Audiology services in the community (adults)
• Continence care (adults and children)
• Diagnostic services (e.g. imaging and heart and lung investigations)
• Wheelchair services (children)
• Podiatry care
• Wound healing and management of leg ulcers
• Primary care psychological therapies (adults).

The guidance also says that PCT clusters and CCGs can choose alternative services for AQP for different priority areas if supported by local patients – for example, as identified through the shadow health and wellbeing boards (the new health and social care joint commissioning boards) – and potential effective gains in quality and access can be made by doing so.

Independent interaction

The principles for the AQP approach are that:

• Organisations can qualify and register to provide NHS services as long as they meet NHS assurance requirements
• Referral pathways and protocols set by CCGs must be accepted by the providers wishing to be on the AQP list
• Patients are offered a choice of services from the list of qualified providers
• There will be a fixed price based on a national or local tariff, thereby ensuring that the provider is chosen by quality.

A national qualification process for all AQP providers is currently being developed by the DH in order to minimise bureaucracy and reduce transaction costs. The proposed principles for qualification are that providers:

• Must be registered with the Care Quality Commission (CQC) to demonstrate that they meet the essential standards for quality and safety – or equivalent assurance requirements if providing services not covered by CQC registration
• Are licensed by Monitor from 2013 so that they are authorised to deliver NHS care
• Can meet the terms and conditions of the NHS Standard Contract, including having regard for the NHS Constitution, appropriate guidance and legal obligations
• Deliver care at NHS prices
• Can meet the service specifications developed by commissioners and comply with referral protocols
• Agree with the commissioners on any supporting schedules to the NHS Standard Contract, e.g. on activity levels.

More details of the qualification process have been published this autumn.

The providers that have successfully achieved the national qualification process have been listed in a directory, which is now published and available for GPs to refer to.

Lead PCT clusters have produced detailed implementation packs for each service on the AQP list that include service specifications, contract currencies, tariffs and information models.

From April 2012 it is anticipated that AQP arrangements for the services identified above will begin to be implemented, with all CCGs having this in place for their patients by September 2012.

What happens next?

AQP will continue to expand and for 2013/14 a further list of services has been identified by the DH for discussion with commissioners, patient groups and providers. The list is not finalised but will probably
include:

• Maternity care
• Speech and language therapy
• Supporting patients to self manage their long-term conditions
• Chemotherapy in the community setting and at home
• Primary care psychological therapies for children and adolescents
• Wheelchair services (adults).

What’s in it for pharma?

At first glance the initial list of services for the first phase of AQP does not appear to have much impact on the pharmaceutical industry, apart from probably wound care management. However, with the second wave of AQP the scope for involvement widens to chemotherapy services at home and in the community setting. The aim for now should be to plan ahead, and the next phase of AQP and pharma should work on this in a number of areas.

Firstly, a keen eye should be kept on the proposed list of services for 2013/14. Whilst some services have been identified for discussion with NHS stakeholders and patient groups, there may be others added later on which could require input from pharma. Once the service areas have been confirmed, the next step is to identify the providers who have been authorised for AQP. These potential providers need to get up to speed in a number of areas, such as ensuring that they are registered with the CQC, have a better understanding of the standard NHS contract, offer services in keeping with the CCGs requirements and can manage within NHS financial envelopes.

Another aim should be to identify the lead commissioner(s) within the local PCT cluster and associated CCGs to find out what which community or mental health services they are planning to include on their local AQP for the next round. Alternatively, contacting the local shadow health and wellbeing
board, if it is sufficiently developed, may indicate other priority areas for AQP.

Service redesign and, in particular, improving care pathways so that more care can be delivered in the community setting will be a priority. Patient self-management of long-term conditions is one such area where better understanding of medication leading to improved compliance achieves better health outcomes. Pharma can provide an invaluable contribution to improving these outcomes for a range of long-term conditions, such as diabetes, asthma, hypertension and arthritis, by helping patients understand the medication through written and electronic patient information and other mechanisms, such as patient self-management programmes.

Through the identification of potential AQPs the industry can work together with these providers to help them meet the qualification requirements for the scheme – for example, some aspects of CQC registration such as infection control, medicines management and clinical risk management. This will be a chance to raise the profile of effective drug therapies in, for example,
chemotherapy.

Although this initiative seems small in scale it does look set to grow in the future, and further opportunities will present themselves for 2013 and beyond as QAP continues to expand. Pharma needs to begin its homework now to identify new markets for their products with this scheme.

Dr Thoreya Swage was formerly an NHS clinician and a senior manager in various NHS organisations covering acute and primary care. She has expertise in commissioning health services and is currently working for a number of NHS organisations, including DH agencies, to develop a more commercial approach to the commissioning of healthcare.

Despite the ongoing criticism of the Health Bill as it passes through the House of Lords, structural changes are still happening at ground level. Dr Thoreya Swage outlines the timescale for changes as PCT clusters switch responsibilities to CCGs.

The momentum of reform of the National Health Service in England continues to gather pace. Following a four month hiatus while the wise and the good of the NHS Future Forum pondered and produced recommendations for the adjustment of the Bill, the DH published further guidance on the developing role of the Primary Care Trust (PCT) clusters.

Although the 151 PCTs have been squeezed into fifty-one PCT clusters in preparation for their demise in April 2013, it seems that they have a vital part to play in the development of the emerging Clinical Commissioning Groups (CCGs).

This guidance or ‘shared operating model for PCT clusters’ has been produced by the mandarins at the DH to ensure that the commissioning landscape is as consistent and smooth as possible in time for the takeover by the CCGs. This is so that the nascent NHS Commissioning Board inherits a robust enough system to take account of further developments and improvements in healthcare in early 2013.

 

A shared model

There are six main functions or ways of working for the shared operating model for the clusters. These have been identified where consistency of approach is considered to be of importance and they are listed as commissioning development, financial and operational issues, ensuring quality, emergency planning, development of providers as Foundation Trusts and communications.

 

CCG development

The most important function is the preparation of CCGs for authorisation as soon as possible following the successful passage of the Health Bill through Parliament. The process of authorisation to become fully fledged commissioners is due to begin in the second half of 2012.

Although this is a year away, CCGs can commence their preparations now using a self diagnostic tool – an interactive computer-based assessment that helps them to determine their capability in six domains and identify their development needs.

The areas covered include:

• A clear clinical focus of the CCG commissioning plans to include tackling health inequalities and improving primary care
• Demonstration of meaningful involvement of patients and the wider community
• A plan for development that is clear and credible which, in particular, delivers the QIPP (quality, innovation, productivity and prevention) agenda
• Capacity and capability of the CCG, i.e. robust constitutional and governance arrangements which enable the CCG to commission care effectively and ensure financial control
• Collaborative arrangements for working with other CCGs, local authorities and the NHS Commissioning Board
• Capacity and capability of the CCG leadership which ensures effective working.

The tool helps the CCGs identify priority development areas which form the basis of the developmental plan paving the way to full authorisation.

To support all this work CCGs will receive £2 per head from the PCT clusters as well as extra management resource to help the groups hone their commissioning skills and capability.

CCGs experiencing difficulty in defining their boundaries will have guidance from PCT clusters on how to resolve this. PCT clusters also have the unenviable task of engaging the reluctant practices that so far have not participated in their local CCG discussions, with the aim of being part of a viable commissioning group by October.

 

Separating commissioning functions

All through the last quarter of this year a very detailed exercise is being carried out by PCT clusters to identify and segregate the service areas that CCGs and the NHS Commissioning Board will be responsible for. Although CCGs will be commissioning acute, mental health, community and ambulance care there are other services that PCTs currently commission which will need to be transferred to the Board.

Services such as GP and other primary care contractor groups – primary dental care, pharmacy and optical services – secondary dental care, prison, specialised and military health services are set to go under the umbrella of the NHS Commissioning Board. Even though the contracts for GP services are held by another body, the CCGs are expected to have an input into primary care development and improvement.

 

Quality assurance

A vital component of the commissioning process is ensuring the quality of healthcare. Practices may have been involved to a greater or lesser degree in various quality assurance processes in the past. However, CCGs are required to take on board these responsibilities seriously.

There is a whole raft of procedures and measures including delivery of better health outcomes for patients, meeting the Care Quality Commission (CQC) requirements for safety and quality of services, standard contracts, the NHS Operating Framework, professional guidance and other relevant requirements that CCGs need to get to grips with.

This could potentially be a vulnerable time for the development of the CCGs if attention wanders and serious patient safety incidents are not acted on promptly. Clinical governance processes must therefore be extra secure.

 

Budgets and responsibilities

Over the next year or so there will be a period of dual functioning and handover as the CCGs mature and the PCT clusters delegate more and more responsibilities until April 2013. The handing over of the baton has started now with PCT clusters having identified a “clear percentage of budgets” to CCG pioneers or pathfinders in August and plans for future delegation of budgets set by October.

Sandwiched in between will be the agreement on which mental health and community services will be subject to ‘Any Qualified Provider’ (AQP). This policy is set to be implemented from April next year when GPs can refer to providers of certain services eligible for AQP from a list of approved organisations, including the private sector, drawn up by the DH.

A review of commissioning support required by CCGs has already been undertaken in July with clear arrangements agreed by the end of the year.

In March next year, CCGs will be required to enable the development of the local health and wellbeing boards supported by their PCT clusters – health and wellbeing boards being the mechanism for joint health and social care planning and commissioning locally.

Meanwhile, individual PCTs will continue to carry out their statutory functions through the clusters until their abolition in April 2013. The statutory functions include contract monitoring, ensuring that providers meet their QIPP obligations and other statutory requirements, for example, safeguarding children and vulnerable adults.

The big challenge for CCGs will begin when they will be required to lead the next planning round for 2012/13. This begins in the latter part of this year and is a function previously undertaken by the PCTs.

This will involve doing a needs analysis, identifying local inequalities, understanding demand and activity for local services, negotiating and setting priorities with partners and developing the local strategic vision. Handover of commissioning functions will continue with CCGs being an active participant in the subsequent contract negotiations and agreement.

 

The outside world

It is apparent that despite the pause for reflection on the proposed changes in the NHS earlier this year, the momentum for restructuring and dissolving healthcare organisations continues. The picture remains a little confusing however, as CCGs are in varying stages of development and maturity and it is not clear that all will be truly viable by the tight deadline set for October.

What is clear is that that work of commissioning and delivering healthcare has to go on and now is a good time to find out who the key movers are within the CCGs.

It is at this point in time when the developmental needs of CCGs will be uppermost and it is here that pharma can provide some input. Skills and knowledge in leadership development and highlighting therapeutic areas where evidence-based care really works are two such possibilities.

CCGs will be keen to smooth patient pathways across primary and secondary care and nowhere is this more pertinent than in prescribing effectively. Delegated prescribing budgets are now very real for CCGs and they will be keen to ensure value for money and improvements in care for their patients. This provides a good opportunity for pharma companies to demonstrate the effectiveness of their drugs in specific disease areas.

On the commissioning front, by December of this year, CCGs and PCT clusters will have had to agree what commissioning support they need to carry out this function. Given the requirement to reduce costs, commissioning skills and expertise may actually be thin on the ground within CCGs.

Bearing in mind that effective commissioning will be judged by outcomes achieved as outlined in the NHS Outcomes Framework, pharma is well placed to demonstrate how their products can meet the requirements of domain 1: preventing premature deaths, domain 2: enhancing the quality of life of people with long-term conditions and domain 3: aiding the recovery of people who have an acute illness or injury.

The next few months will be busy while the NHS sorts itself out structurally. Once the picture begins to clear, pharma will need to engage with the new clinically skilled commissioners who now have the financial responsibility for making decisions about healthcare.

Dr Thoreya Swage was formerly an NHS clinician and a senior manager in various NHS organisations covering acute and primary care. She has expertise in commissioning health services and is currently working for a number of NHS organisations, including DH agencies, to develop a more commercial approach to the commissioning of healthcare.