Maxine Vaccine wonders whether reports of the death of top-down NHS control have been exaggerated.

The Government has been very clear that its slogan ‘Liberating the NHS’ means just that. It wants to liberate the NHS – by which it means clinicians – from bureaucracy and political interference. That’s why it has given control of local commissioning to CCGs, which are GP-led and represent both clinical expertise and local experience.

With that in mind, the new DH consultation document Securing best value for NHS patients makes interesting reading. It presents a draft of regulations to ensure that CCGs observe “choice and competition” in their commissioning decisions.

A particularly striking observation is: “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 will no longer be binding on the autonomous commissioners, so the law must be used to ensure they don’t misuse their freedom. It won’t be top-down guidance then, it will be the law of the land.

The DH states the core responsibility of local commissioners: “to secure best value from limited resources”. It wants CCGs “to have flexibility to decide how to respond to these challenges”. However, it says, in the past NHS commissioners have limited their own flexibility through “bureaucratic processes” and “inappropriate criteria”. These must be prohibited. Where the commissioners are not flexible enough, flexibility must be imposed upon them.

What is required is that CCGs “carry out an objective assessment of different options” according to the Government’s criteria, not their own. In particular, they must choose providers with “quality and efficiency” in mind, without any preference being shown for public sector providers over voluntary or private sector ones. They will have to maintain records for audit by Monitor to show that they have followed the correct procedure at every stage.

In other words, it is not the CCG that decides what “quality and efficiency” is, it is the Government. The CCG must follow a detailed, transparent procedure to ensure that its commissioning choices are in line with those “objective” criteria. It will now be a criminal offence for a CCG to “prevent, restrict or distort competition” unless that can be proven “indispensable” to patient benefit in the face of a legal challenge.

This means that ‘clinical commissioning’ is being brought into the framework of company law, a battleground for commercial and legal forces. Are GPs really being ‘liberated’ by this? Or are they being reduced to a lower-level bureaucratic role where they carry out decisions made by lawyers and financial managers, with private healthcare corporations pulling the strings?

And is that why most GPs are staying out of the local commissioning game?

Maxine’s views are not necessarily those of Pharmaceutical Field.

Health Secretary Andrew Lansley has said the amendments made to the Health and Social Care Bill in its passage through Parliament made no fundamental difference.

The purpose of the ‘listening exercise’ was primarily to help clinicians understand the Bill better, Lansley told the journal GP Business.

A British Medical Association spokesperson said the Health Secretary’s statement was “not a remote surprise” to its members.

In an interview, Lansley claimed the main reason for opposition to the Health Bill was that critics had not read the White Paper Liberating the NHS – “or even if they had read it they had not really understood it or engaged with it”.

However, he expressed regret that the ‘listening exercise’ had not taken place “three or four months earlier”.

The many amendments to the Health Bill conceded by the Government at the House of Lords stage were needed to compensate for the slow engagement of NHS professionals with the reform process, Lansley asserted.

“Although we made further amendments in the Lords, in truth, a lot of those amendments were practical things in order to give further reassurance,” he said. “They did not really fundamentally change the principles at all.”

The BMA, which opposed the Health Bill after what it considered the failure of the ‘listening exercise’ to deal with the concerns of doctors, responded angrily.

“The majority of the health profession is aware the Bill’s fundamental principles look pretty similar to its original draft – it is not a remote surprise,” said Dr Laurence Buckman, Chair of the British Medical Association’s GP Committee.

“Furthermore, the amendments made to the Bill have certainly not offered the profession any reassurance and in fact some of the reform’s implementation plans have been made less attractive by the changes made to the legislation.”

By Pf Editor, Chris Ross

Another day, another debate about NHS reform. Late last month, the Guardian ran an interesting piece about the latest YouTube opus to ‘go viral’ – a rap that lambasts the DH White Paper, Liberating the NHS. In it, 22-year old Loughborough binman-cum-Twitter-celebrity, MC NxtGen, repeatedly – and personally – attacks the Health Secretary and his plans. It’s a powerful refrain:

“Andrew Lansley, greedy! Andrew Lansley, t*sser! The NHS is not for sale, you grey-haired manky codger.”

It is neither articulate nor poetic, but, in the competitive world of social media, it has achieved ‘cut through’ and sparked a Twitter and Facebook frenzy. In fact, its message is strengthened by an artist who has clearly done his research. NxtGen has been able to deliver his critique of the proposed reforms in a much more succinct fashion than Lansley himself has been able to do in selling his policies to the general public. It’s worth a listen – though I’m not sure I’d download his album.

Subsequently, the beleaguered Health Secretary has done his best to show he’s ‘down with the kids’. The Government is to take a ‘natural break’ in the passage of the Bill, to engage further with stakeholders and critics – and to ‘reassure’ opponents over fears of privatisation. Lansley wants us to know he’s listening – to MPs, to clinicians and to 22-year-old binmen from Leicestershire.

As ever, proposed amendments abound. The latest come from the House of Commons’ health committee,who claim the Bill’s determination to place commissioning responsibilities solely in the hands of GPs is a mistake. In a proposal that would have ramifications for UK pharma’s already evolving customer-base, the committee says family doctors should be joined by a range of other stakeholders, including nurses and hospital doctors, in deciding how NHS funds are spent. It advocates replacing prospective GP Consortia with “NHS Commissioning Authorities” that capture opinion from other specialities.

The listening government has already dismissed the idea. Perhaps its architects need to re-present it as a 3-minute rap.

Contact the author: chris.ross@healthpublishing.co.uk

Many doctors think the proposed NHS reforms will bring more risks than benefits, a survey for the BMA has shown.

An Ipsos MORI survey of BMA members has revealed that the majority of doctors are not convinced that the potential benefits of the government’s plans for the NHS in England outweigh the risks.

The reforms were laid out in the White Paper Equity and Excellence: Liberating the NHS in July 2010 and this year’s Health and Social Care Bill, which is currently going through its House of Commons committee stage.

A third (33%) of respondents said they are broadly opposed to the reforms, around a fifth (18%) are broadly supportive, and just over a third (36%) say they are waiting to see what happens. However, even within the ‘pro-reforms’ group, 67% agree that increased competition in the NHS will lead to a fragmentation of services.

Several statements had high levels of agreement among the 1,645 respondents, these were:

· Increased competition in the NHS will lead to a fragmentation of services (89% agree)

· Increased competition in the NHS will reduce the quality of patient care (65% agree)

· The move for all NHS providers to become, or be part of, foundation trusts will damage NHS values (66% agree)

· The proposed system of clinician-led commissioning will increase health inequalities (66% agree)

The survey also suggests that doctors believe the changes that are most likely to be achieved are those which are least welcome, such as increased competition between providers, and the changes that would be most beneficial are least likely to be achieved, i.e. closer working between general practice and hospitals.

Three fifths of respondents (61%) think it likely that the reforms will lead to them spending less time with patients, a change which only 1% would welcome.

Dr Hamish Meldrum, Chairman of Council at the BMA (pictured), said: “This survey shows that the government can no longer claim widespread support among doctors as justification for these flawed policies. The government simply cannot afford to dismiss this strength of feeling amongst the group they are expecting to lead much of the change.”

Many doctors think the proposed NHS reforms will bring more risks than benefits, a survey for the BMA has shown.

An Ipsos MORI survey of BMA members has revealed that the majority of doctors are not convinced that the potential benefits of the government’s plans for the NHS in England outweigh the risks.

The reforms were laid out in the White Paper Equity and Excellence: Liberating the NHS in July 2010 and this year’s Health and Social Care Bill, which is currently going through its House of Commons committee stage.

A third (33%) of respondents said they are broadly opposed to the reforms, around a fifth (18%) are broadly supportive, and just over a third (36%) say they are waiting to see what happens. However, even within the ‘pro-reforms’ group, 67% agree that increased competition in the NHS will lead to a fragmentation of services.

Several statements had high levels of agreement among the 1,645 respondents, these were:

· Increased competition in the NHS will lead to a fragmentation of services (89% agree)

· Increased competition in the NHS will reduce the quality of patient care (65% agree)

· The move for all NHS providers to become, or be part of, foundation trusts will damage NHS values (66% agree)

· The proposed system of clinician-led commissioning will increase health inequalities (66% agree)

The survey also suggests that doctors believe the changes that are most likely to be achieved are those which are least welcome, such as increased competition between providers, and the changes that would be most beneficial are least likely to be achieved, i.e. closer working between general practice and hospitals.

Three fifths of respondents (61%) think it likely that the reforms will lead to them spending less time with patients, a change which only 1% would welcome.

Dr Hamish Meldrum, Chairman of Council at the BMA (pictured), said: “This survey shows that the government can no longer claim widespread support among doctors as justification for these flawed policies. The government simply cannot afford to dismiss this strength of feeling amongst the group they are expecting to lead much of the change.”

After the proposed reforms in the White Paper and resulting consultation papers, Thoreya Swage dissects what the changes will mean and how pharma will have to find its feet once again.

Amongst the papers out for comment on the next steps for the NHS were a couple of documents outlining the future of the Arm’s Length Bodies and how the Health Service would be regulated over the next few years.

Liberating the NHS: Regulating healthcare providers outlines the proposals for the further development of foundation trusts together with a wider role for Monitor. The underlying principle is the desire of the Government to free up providers to improve outcomes through regulatory licensing and clinically-led contracting, rather than via central or regional controls. The intention is to regulate foundation trusts in the same way as for other providers in the private sector, although the paper stresses that Trusts themselves will not be privatised. The ultimate aim will be for all NHS providers to become, or be part of, a foundation trust and, from 2013, Monitor will have the responsibility of regulating all providers of NHS services, regardless of their status. NHS Trusts providing healthcare will not be permitted to remain.

A new sense of freedom
The main purpose of the trusts will continue to be the provision of goods and services to the Health Service in England and any surplus or proceeds from the sale of assets to be reinvested in healthcare. Previously the level of private income permitted was capped causing much difficulty for some trusts. They encountered not being able to expand their services whilst others were restricted, particularly mental health trusts, to provide services not directly funded by the NHS, such as return to work schemes. Statutory controls on borrowing are also planned to be lifted within the new regulatory system.

In the new world trusts will be able to amend their own constitutions rather than seeking permission from Monitor. The constitution however has to be within the legal framework set by Government. It will be easier for foundation trusts to merge or to acquire another NHS organisation or to de-merge subject to the competition rules.

Currently all foundation trusts have a three-tier structure of members, governors and directors determined by specific statutory requirements with respect to the composition of a foundation trust’s membership, boards of governors and of directors. The consultation paper suggests that this could be improved to increase the influence of staff. In some instances this could be developed further with some trusts, specifically smaller community bodies, to be led solely by employees.

Accountability of the trusts to its governors will also be strengthened. For example, permitting the calling of a special general meeting in order to hear reports on executive pay or approve significant transactions. Furthermore, there is a proposal that the current arrangement, whereby if a foundation trust fails the taxpayer picks up the tab, will be changed to a system ensuring that financial investment and risk is managed as much as possible on a commercial basis.

Regulating and monitoring healthcare
In another consultation paper, Liberating the NHS: Report of the arm’s-length bodies review the Government is rationalising the numerous organisations that oversee improvements in healthcare. The proposal is to have just one regulator on quality, the Care Quality Commission (CQC), and one economic regulator in Monitor for all providers of NHS care. The document also proposes that there should be only one regulator for medicines and devices, the Medicines and Healthcare Products Regulatory Agency (MHRA), and one research regulator – a new body set to be established.

In its new guise Monitor will become the only economic regulator for the NHS and for social care in England. By promoting competition and regulation where necessary Monitor will undertake its key duty of protecting the interests of patients and the public in health and adult social care services. The plan is for anti-competitive behaviour by such bodies to be dealt with through regulation rather than via costly legal processes.

Monitor will scrutinise the equitable and safe access to health and social care services by patients and facilitate improvements in organisational efficiency. It will ensure value for money and promote investment and innovation within services. A major function will be helping commissioners maintain continuity of essential services. These have not yet been defined but it is thought to be services such as accident and emergency and maternity care.

The body will be responsible for setting the maximum prices for NHS funded services. The NHS Commissioning Board will determine the currencies – units of services, pathways, etc – whereas Monitor will devise the pricing methodology and price cap for such services.

The four core functions of Monitor will be the licensing of all providers of NHS care, price regulation of NHS care, promoting competition and supporting service continuity. In carrying out its multiple functions Monitor will need to take a view on possible conflicting situations.  Although the paper says that Monitor will be independent, it also states that the Chair and Chief Executive will be appointed by the Secretary of State.

Checks and balances will be in place to ensure that Monitor acts fairly. For example, there will be a requirement to consult with other bodies such as the NHS Commissioning Board and providers to conduct impact assessments of the costs and benefits of new regulation, and an appeal mechanism against certain licensing and pricing decisions.

The CQC will continue as the quality inspectorate for health and social care for NHS and privately funded services, perform reviews of adult social care and retain its responsibilities under the Mental Health Act.

The NHS Commissioning Board will take over the assessment of NHS commissioners. The commission will continue to register all providers who wish to provide regulated activities as defined under the Health and Social Care Act 2008 to provide assurance that the services meet essential levels of quality and safety. It will also carry out inspections in relation to the registration requirements and undertake enforcement action where required.

Monitor’s role is to regulate prices and license providers of NHS care. The licensing conditions include the requirement that organisations are fit and able to provide NHS services, details on the types of services provided and notification to a change of services. In certain circumstances specific requirements may be set, for example, a requirement to provide specific services to competitors to promote competition or pre-notify Monitor of plans to discontinue an essential service. Providers of other care, e.g. social care, will not be required to be licensed with Monitor, although they are required to be registered with the CQC. In the future it will be a requirement for organisations to have CQC registration prior to obtaining a licence from Monitor for NHS care.

NICE will continue to play a key part in providing advice on intervention, quality and health technologies for clinical services and public health. In addition to its extended role in developing Quality Standards to support the main pathways of care for the NHS Commissioning Board and GP consortia to use, it will also publish Quality Standards for adult social care. The paper however, makes no reference to NICE’s role in providing advice on whether new drugs should be made available to patients using NHS services. The Secretary of State has said that this would be left to the GP consortia to decide and the cost of the drug to be decided on a new ‘value-based pricing’ system.

Implications for pharma
The main message is that the statutory landscape is being prepared for smarter, more commercially minded healthcare organisations to deliver better care and improved outcomes. As always this means developing services that meet patients’ needs locally. The removal of NICE’s role in determining whether a new drug should be prescribed or not allows for that flexibility. However, it is not back to the hard sell to clinicians. Prices for new interventions will be based on not only clinical effectiveness but also reduction on the burden of carers, availability of alternative treatments and how innovative the company has been in producing the drug.

This new environment means that pharma will need to work with providers to demonstrate this innovation to commissioners through support and development of more streamlined pathways of care as determined by the Quality Standards published by NICE.

The establishment of community Foundation Trusts run by their staff together with the greater emphasis on management of chronic diseases provides an opening for pharma to influence the development of services for conditions such as asthma, COPD, coronary heart disease and stroke, and mental illnesses. It is much easier to develop services when talking directly to those that deliver the care.

The removal of the cap on the private income of Trusts means that these services will expand leading to a greater demand for drugs within that sector. Pharma needs to get close to its customer Foundation Trusts to find out which services are to be developed in order to have a say in such decisions.

Clearly, regulation and competition are the way forward and the challenge for the industry is to use its experience and expertise to support the new Foundation Trusts of the future.

Dr Thoreya Swage has several years’ experience in the NHS, both as a clinician (psychiatry) and as a senior manager, including Executive Director for a Health Authority, in various NHS organisations covering acute and primary care. She has expertise in commissioning health services, most recently working with the independent sector as part of the Independent Sector Treatment Programme at the DH. She is currently working for a number of NHS organisations, including DH agencies, to develop a more commercial approach to the commissioning of healthcare.

Liberating the NHS, the Government’s blueprint for healthcare in the UK, proposes an unprecedented and radical reorganisation for the NHS. Still ‘free at the point of use’, the White Paper remains true to the core principles of the NHS. But its desire to provide patients with the freedom of choice and, crucially, GPs with the freedom to commission services, suggests some challenging times lie ahead. In these turbulent economic times, not all that is good can be free. Chris Ross takes an early glance at the White Paper.

Strategic Health Authorities (SHAs) and Primary Care Trusts (PCTs) are to be scrapped and hospitals encouraged to move out of the NHS to create a ‘vibrant’ industry of social enterprises, as part of radical proposals to restructure the NHS in England.

The new White Paper, Equity and Excellence: Liberating the NHS, outlines how power will be devolved from Whitehall to patients and professionals – and gives GPs freedom to take charge of much of the budget.

GP consortia

Consortia of GPs will be given the responsibility for buying care from local hospitals and other providers as the balance of purchasing power shifts from central management to the GP surgery. The consortia will control upwards of 70% of the NHS budget – approximately £80 billion. The majority of commissioning will be undertaken by GP-led consortia – with the rest being done by a new NHS Commissioning Board.

The NHS Commissioning Board will be “a lean and expert organisation, free from day-to-day political interference, with a commissioning model that draws from best international practice”. The White Paper states that the Board will: “support GP consortia in their commissioning decisions and provide leadership for quality improvement through commissioning: through commissioning guidelines it will help standardise what is known good practice, for example improving discharge from hospital, maximising the number of day care operations, reducing delays prior to operations and enabling community access to care and treatments. It will not manage providers or be the NHS headquarters.”

Subject to consultation, the Government’s indicative timetable for GP consortia is to be as follows:

· A comprehensive system of GP consortia in place in shadow form during 2011/12, taking on increased delegated responsibility from PCTs.

· Following passage of the Health Bill, consortia to take on responsibility for commissioning in 2012/13.

· The NHS Commissioning Board to make allocations for 2013/14 directly to GP consortia in late 2012.

· GP consortia to take full financial responsibility from April 2013.

The abolition of PCTs, which will take place ‘from 2013’, is seen as a major policy u-turn for the new government, having ruled out top-down NHS reorganisations in the coalition Programme for Government back in May. However, Health Secretary Andrew Lansley said the about turn was simply because his other reforms had left nothing for PCTs to do. “If we don’t have a job for primary care trusts to do, it doesn’t make sense to be paying thousands of people to do it,” he said. The policy is expected to result in tens of thousands of redundancies, with the cost of NHS management aiming for a 45% reduction over the next four years. “Inevitably, as a result of the record debt, the NHS will employ fewer staff at the end of this Parliament,” said Lansley. “That’s a hard truth which any government would have to recognise.” The NHS is charged with finding efficiency savings of £20 billion during the same period in which it hopes to drive through the reforms.

Foundation trusts

The White Paper says that all NHS Trusts will become Foundation Trusts within three years. This, it says, will create the largest and most vibrant social enterprise sector in the world. “The intention is to free foundation trusts from constraints they are under, in line with their original conception, so they can innovate to improve care for patients. It will not be an option for organisations to remain as an NHS Trust, rather than become or be part of a foundation trust.” The NHS Trust legislative model will be repealed in due course, while SHAs will be abolished by 2012 – and their responsibilities in relation to providers will be undertaken by a new unit within the Department of Health. From April 2013, responsibility for regulating all providers of NHS care will be passed to Monitor.

Patient choice

The Government aims to make the NHS more accountable to patients, who, it says, will be at the heart of everything it does. As such, the White Paper promises patients will have more choice and control, which will be supported by easier access to the information they need about the best GPs and hospitals. The ‘information revolution’ promised by Lansley has spawned a new slogan to sum up the approach to patients: ‘no decisions about me, without me.’

To help deliver this, a new body, HealthWatch, will be set up to compile data on performance, while GP boundaries will be abolished to allow patients to register with any doctor they want.

The Paper says: “We want the principle of ‘shared decision-making’ to become the norm: no decision about me, without me. International evidence shows that involving patients in their care and treatments improves their health outcomes, boosts their satisfaction with services received, and increases not just their knowledge and understanding of their health status but also their adherence to a chosen treatment. It can also bring significant reductions in cost, as highlighted in the Wanless Report, and in evidence from various programmes to improve the management of long-term conditions.”

Information generated by patients will be critical to the process, and will include much wider use of tools such as Patient-Reported Outcome Measures (PROMS), patient experience data and real-time feedback. The use of PROMS and other outcome measures will be expanded across the NHS, while the DH will extend national clinical audits to support clinicians across a wider range of treatments and conditions.

NICE and quality standards

The Government says the central aim of its programme of reform, and indeed of the NHS, is the drive to improve health outcomes. Progress on outcomes will, it says, be supported by quality standards. These will be developed for the NHS Commissioning Board by NICE, who will develop authoritative standards setting out each part of the patient pathway, and indicators for each step. NICE will rapidly expand its existing work programme to create a comprehensive library of standards for all the main pathways of care. The first three on stroke, dementia and prevention of VTE were published in June. NICE expects to produce 150 standards within the next five years and, to support quality standards, will advise the National Institute for Health Research on research priorities. The role of NICE will also be expanded to develop quality standards for social care.

The White Paper notes the absence of an effective payment system within the NHS which it says restricts the ability of commissioners and providers to improve outcomes, increase efficiency and deliver patient choice. Responsibility for the future structure of payment systems will belong to the NHS Commissioning Board and the economic regulator will be responsible for pricing. The DH plans to refine the basis of current tariffs and to accelerate the development of best-practice tariffs, introducing an increasing number each year so that providers are paid according to the costs of ‘excellent care’ rather than average care. Best-practice tariffs for interventional radiology, day-case surgery for breast surgery, hernia repairs and some orthopaedic surgery will be introduced in 2011/12. Alongside this, the DH will also extend the scope and value of the Commissioning for Quality and Innovation (CQUIN) payment framework.

Value-based pricing

Reforms to the way in which drug companies are paid for NHS medicines are also on the way, with proposals to move to a system of value-based pricing when the current scheme expires. “This will help ensure better access for patients to effective drugs and innovative treatments on the NHS, and secure value for money for NHS spending on medicines,” the White Paper states. As an interim measure, the DH is creating a new Cancer Drug Fund, which will operate from 2011. “This fund will help patients get the cancer drugs their doctors recommend.”

ABPI response

The ABPI has welcomed the proposals, in particular the extended remit of NICE which, it says, will help it move beyond a narrow focus on the cost-effectiveness of medicines. Dr Richard Barker, Director-General at the ABPI, said: “We warmly welcome the Government placing outcomes at the heart of health policy, a move we have long advocated. We must ensure that the new era of commissioning builds in the intelligent prevention, early diagnosis and timely treatment necessary to halt the burden of chronic disease that threatens the financial future of the NHS. The NHS spends more on unplanned hospital admissions for chronic disease sufferers than it does on medicines that, if used appropriately, could prevent them.”

The move towards a more clinically-led NHS is also supported. “We are also pleased that the White Paper signals a move towards greater doctor and patient influence over clinical decisions. We agree with Government that it is important to set quality standards for the new era of GP-led commissioning and we welcome the involvement of NICE in this process. The ABPI believes that this expansion of NICE’s remit to promote clinical best practice is a higher priority for the future of the NHS than the overly narrow cost-effectiveness calculations on new medicines it currently conducts. The new Government also proposes to introduce a Cancer Drugs Fund and to review how better to reflect value in the pricing of NHS medicines. We look forward to working with the Government to develop these proposals further whilst maintaining the stability of the current PPRS agreement.”