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.

More than half of GPs see accusations of conflicting interests as the greatest danger of the new CCG system.

A survey of more than 1,000 GPs and practice managers by medical indemnity provider the Medical Protection Society (MPS) revealed that 59% were afraid of losing patient trust through their role in the new NHS.

The survey indicates that the new regulations enforcing competition in CCG commissioning are unpopular with the majority of GPs, who see a threat to the doctor-patient relationship.

MPS warned that without “clear and robust governance structures and processes” within CCGs to deal “openly” with perceived conflicts of interest, public confidence in the new NHS could be eroded.

Dr Richard Stacey, Editor of the new WPS journal Practice Matters, said: “MPS has always had concerns that CCGs could place GPs in a potentially challenging position of being not just the patient advocate but also the budget holder, and we believe this leaves GPs vulnerable to accusations of conflicting interests. This survey not only confirms MPS’s fears but those of GPs and practice managers.”

Responding to the survey findings, Dr Mark Porter, Chair of the BMA Council, commented: “The BMA believes that any GP who has financial interests in a private sector company that might be awarded contracts in their area should consider seriously whether they should be a member of a (CCG) governing body.”

He added that the economic pressures facing the NHS will threaten patient and public confidence in GPs, as they will come to be seen as rationers rather than providers of services: “Ministers must ensure that CCGs have an appropriate level of resources so that they can meet the needs of their patients.”

The new NHS structure came into force on 1 April, with local commissioning now entrusted to clinical commissioning groups (CCGs) that combine business and clinical expertise.

The CCGs are managed by NHS England (formerly the NHS Commissioning Board) and governed by new laws that enforce a ‘level playing field’ for provider competition.

The 152 Primary Care Trusts are now abolished, and all NHS hospital trusts are required to qualify for Foundation Trust status within the next year.

NICE, renamed the National Institute for Health and Care Excellence, will set standards for both health and social care services, promoting integrated care.

The statutory role of CCGs in facilitating competition between providers of NHS services has polarised opinion, with only a third of GPs in a Pulse survey saying they felt empowered by the new system.

According to private health analysts Laing and Buisson, the NHS in England spent 11% more on services from private providers in 2012 than in 2011 – a clear sign that the provider base is already shifting.

Professor David Haslam, the new Chairman of NICE, commented: “It is a time of huge risk. We know in medical care in hospital that the greatest risk is when patients are being handed over from one person to another. It is a risky time for the system, so it is important that the big players work together.”

Mike Farrar (pictured), Chief Executive of the NHS Confederation and a long-time champion of community-based healthcare, warned that trying to improve patient safety while reducing costs would place great pressure on the new NHS.

“We need to recognise the huge challenges facing the health service,” he said. “New structures alone won’t enable us to tackle these challenges, and we should not see them as a silver bullet.”

The introduction of CCGs has not made doctors feel more involved in commissioning decisions, a new survey has revealed.

Research by Pulse magazine found that out of 303 doctors questioned more than half (55%) said they do not feel any more involved in commissioning services now than they did under PCTs.

Only 36% of GPs surveyed said the introduction of CCGs had made them feel more involved in commissioning decisions.

Dr Chaand Nagpaul said the lack of engagement was a result of the Government pushing the reforms through “at breakneck speed” which did not allow for “adequate involvement and organic development”.

The survey also found that a fifth of GPs had not signed their CCG constitution – only days ahead of commissioning groups taking on their new responsibilities. Doctors who had not signed a constitution, claimed they had either not been asked to or that the documents were still in draft form.

A health expert has predicted that the failings of CCGs will see them replaced after only two years by a more effective system of commissioning healthcare services.

Kieran Walshe, Professor of Health Policy Management at Manchester Business School, told the BBC 4’s Today programme that there are no real benefits to GP-led commissioning and accused the Government of being obsessed with this approach.

“This is the most recent version of GP-led commissioning,” he said. “None of them have worked very well. The research suggests there aren’t really great benefits in GP-led commissioning, so why this Government is embarking upon essentially doing the same thing is very hard to follow.”

Professor Walshe said the UK should follow the commissioning models adopted across Europe to get better value for money. He claimed that larger organisations instead of smaller commissioning groups are in a better position to leverage better deals for patients.

“GP commissioning groups are smaller than the old PCTs and are going to be like ‘corner shop commissioners’ – who gets better value for money? A corner shop or a supermarket?” he said.

“The change in all of this which is really interesting is the creation of the NHS Commissioning Board and its local area teams. That’s commissioning at scale. They’re going to be dealing with around 40% of the budget and they will be the driving force in this. In two years’ time I suspect we’ll be back sitting around a table saying ‘CCGs haven’t worked. What shall we put in their place?’ But the scale of commissioning by the NHS Commissioning Board may have some future.”

Dr Michael Dixon, NHS Alliance Chair and acting president NHS Clinical Commissioners, argued that Professor Walsh’s prediction was inaccurate and GP-led commissioning will see improved standards of care. “The benefits [of CCGs] are that doctors and nurses that actually see patients make the decisions as to what needs to happen,” he said.

“The Nuffield Trust report showed only last week that money continues to go into hospitals and not into primary care services. What we need to do is to turn that around.”

The new rules for tendering of NHS services have been defended by Health Minister Earl Howe and condemned by the Royal College of Midwives (RCM).

According to Earl Howe, the regulations do not enforce competitive tendering: they simply enforce patient choice.

However, the RCM is concerned that Monitor is being given the power to enforce competitive tendering in virtually all circumstances, while the promised ‘discretion’ of CCGs is abolished.

The difference in views relates to the question of which is more important to patients: the right to exercise choice, or the continuity and integration of services.

The NHS (Procurement, Patient Choice and Competition) Regulations 2013 are secondary legislation following the Health and Social Care Act, and will become law on April 1 unless actively challenged.

Following widespread criticism, Earl Howe said: “These regulations are about ensuring that when services are tendered for, whether from NHS, voluntary sector or independent providers, the rules that are applied to the process are fair.

“We have always said that competition in the NHS should never be pursued as an end in itself, but only where this is in the interests of patients. “This principle underpins the right of patients to exercise choice when accessing treatments.”

The concern of critics – including Labour peer Lord Hunt, the RCM and NHS campaign groups – is that decisions about tendering will be driven not by patient choice, but by lawyers acting for private healthcare providers.

The RCM, which represents maternity service professionals across the UK, argued that the new regulations abolish the control of local NHS commissioners over what services will be open to competitive tendering.

Expressing concern that a business-driven carve-up of the NHS franchise will damage the continuity and integration of maternity services, the RCM called for the new regulations to be debated in both Houses.

Jon Skewes, the RCM’s Director for Policy, Employment Relations and Communications, commented: “We were repeatedly assured by ministers that compulsory competitive tendering would not be imposed on organisations commissioning maternity services. The regulations as they stand will mean that this is exactly what will happen.

“Continuity of care is vital in maternity services if we are to have safe and high quality care. I fear that the fragmented service that these regulations could lead to will mean poorer care for women, babies and their families.”

In the new Pf, Health Secretary Jeremy Hunt answers some questions from our readers. Maxine Vaccine delivers a brief audit report on his answers.

The most vital thing to remember about Jeremy Hunt is that he’s not Andrew Lansley. The older man spent nine years dreaming up a transformation of the NHS into a competitive healthcare market system, then claimed he’d had to invent it out of thin air when, as part of the new coalition government, he “saw the books” (which he’d had full access to for nine years) for the first time. Then he drove through legislation designed to break up the NHS and place its fragments on the bargain shelf of global corporate business, and mocked anyone who questioned it. Forced into a cosmetic display of ‘consultation’, he followed it up by declaring that the ‘listening period’ had been needed only to educate the ignorant doctors.

And suddenly, the Tories are faced with the prospect of losing power. Journalists are calling the Health and Social Care Act ‘Cameron’s poll tax’. Cue the new Department of Health. Exit the sneering headmaster and enter the elegantly half-smiling head boy. Who doesn’t half scrub up well, and – unlike Lansley – can say “the NHS is one of our greatest assets” without crossing his fingers behind his back. Jeremy Hunt was a contributor to Direct Democracy (2005), a Conservative Party activist guide that claimed the NHS was “no longer relevant” to modern society because it was a public sector health system. But he can say “the NHS is one of our greatest assets” because he can say anything. Lansley is a Thatcher type of politician, whereas Hunt is a Blair type.

His answers to the Pf questions are classic examples of why he has been drafted in to front NHS reform up to the next General Election, or at least part-way there. He never says the wrong thing. If he can’t say the right thing, he says nothing in a nice way. He makes you feel that anyone who disagrees with him must be insane. It’s only when you compare his words with what is actually going on that things get complicated – and you realise that, as a new lease-holder in the house that Lansley built, he has only unpacked the suitcases for two rooms: the front room and the bathroom. The rest of the house is unoccupied.

Regular Pf contributor Omar Ali asked Hunt a question about NHS rationing: how will making patients pay for services be integrated into the wider healthcare bill implementation? A good question, as this is already happening: patients in many areas are being told they cannot have cataract operations, varicose vein surgery or hip/knee replacements unless either (a) they wait until their need is greater (for example, they can have cataract surgery once they are blind) or (b) they go private. Referral management, which Sir David Nicholson is very keen on, is another form of rationing: if patients want to see a specialist in many situations, they have to go private. Hunt’s response is worth quoting in full:

Let me be absolutely clear on this – the NHS will always be free at the point of delivery and no one will be asked to pay for its services. Yes, in the future, services will be provided differently – public health services will be organised by local authorities, for example – but the founding principle of those NHS services being free, for those who need it, will never change.

Hunt is neatly splitting the hair of Omar Ali’s question. If people are paying for services they are not NHS services, they are private. But money will still be changing hands for services that used to be free. They just won’t be NHS services any more. And that “for those who need it” is significant. It has two aspects: severity of clinical need (already a moveable famine) and ability to pay (Direct Democracy suggests the NHS should become a means-tested state reimbursement of private healthcare fees). Who needs free healthcare, and what free healthcare they need, will be critical issues from now on – and legally, the Health Secretary now has no remit to influence those decisions, which will be made by autonomous CCGs and/or the autonomous Commissioning Board.

Pf reader Susan Ranch asked whether the Government’s recent announcement that it will cap individual payments for social care at twice the Dilnot-recommended level means that more NHS funding will be committed for elderly patients. Hunt replied: This is incorrect. The Government has not said this and no decision has been made. Strictly speaking, he is right. According to the BBC and three Tory-loyal newspapers (the Sunday Times, the Daily Mail and the Daily Express), journalists were briefed that setting the social care payment cap at £75k (whereas Dilnot had recommended £35k) would feature in the Government’s mid-term review. But it did not – and the critical backlash from social and healthcare experts was either unnecessary or effective, depending on your interpretation. Whatever its level, the cap appears unlikely to be implemented before the 2015 election.

Hunt went on to say: I want this country to become one of the best places in Europe to grow old and make sure people can live independent and healthier lives into old age. Which is the kind of gold-plated soundbite Lansley never delivered.

Another Pf reader, Leigh Saunders, asked how the pharmaceutical industry could work with the NHS to improve cancer survival rates. Hunt replied: The pharmaceutical industry already plays a vital role in improving the health of people with cancer. I want to improve mortality rates, where the targeting and development of medicines is becoming ever more important. I am sure the pharmaceutical industry will want to build on its work in this area and help improve cancer care.

Great stuff: that flatters the industry, expresses a decent medical aim, and then flatters the industry again. It doesn’t answer the question, but who cares?

Jeremy Hunt’s management of the Pf questions is a masterclass in accessible spin. It tells us almost nothing about Government policy, but it tells us why Hunt currently holds the lease on the house of NHS reform. He knows how to make it look good – and in politics, that’s not always easy. The pharma industry should recognise Hunt’s talents as those of marketing and sales. He’s one of us.

Maxine’s views and attitude are not necessarily those of Pf.

The Department of Health has outlined plans to make personal health budgets (PHBs) available to the 56,000 people receiving NHS continuing healthcare from April 2014.

It also anticipates that CCGs will offer PHBs to millions of people with long-term conditions.

However, it has admitted that no training or infrastructure exists to make this transformation of NHS care provision work.

A more fundamental change than the NHS reforms, the introduction of personal health budgets makes patients responsible for commissioning their own care.

Based on a three-year pilot study with 2,700 patients in 20 sites, the DH is confident that this system will reduce GP visits and hospital admissions, and so cut the cost of NHS care.

Patients will receive an agreed sum of money and will be responsible for designing a care package and choosing providers.

NHS continuing healthcare is provided outside hospital for people with ongoing healthcare needs – i.e. people with a complex medical condition that requires a lot of care, including specialised nursing support.

At a conference organised by the Westminster Health Forum, the DH’s PHB team leader Alison Austin said the new system offers “fantastic opportunities” for integrated care with better outcomes at less cost.

However, she said, healthcare providers currently lack the capacity to manage this “huge” change in the organisation of NHS care.

Other speakers at the conference discussed the challenge of taking responsibility for patient care out of the hands of clinicians.

Sarah Carr, a senior analyst at the Social Care Institute for Excellence charity, noted that patients choosing their own care package would represent “a really big challenge for clinicians schooled in evidence-based medicine”.

Jay Dobson, one of the organisers of the PHB pilot scheme, said the new approach would “revolutionise” NHS care – but at present, providers were unaware of it, and the healthcare market was not ready to provide that level of choice.

Further aspects discussed included the role of the voluntary sector (supported by CCG funding) in helping patients to manage their options; and the need for legal support to help commissioners draw up contracts.

The NHS Commissioning Board has identified the enforcement of generic prescribing as one of its key priorities for 2013.

A study commissioned by the Board found the NHS could save £200m per year by replacing two branded statins with generic alternatives, and annual savings of up to £1bn could be achieved across all prescribing.

The study recommends that GPs with expensive prescribing habits should be required to explain their decisions to the CCG – thus potentially creating conflicts between CCGs and pharmaceutical companies.

An embargo on branded drugs where generic versions exist could also see deep erosion of the specialised biopharmaceuticals market by biosimilars.

Branded drugs are often more recognisable, easier to swallow and even easier to digest than generic alternatives – but they can cost up to 25 times as much.

Open Health Care UK and data research company Mastodon C analysed the prescribing of two statins across the country. Many GPs were still prescribing branded versions, despite the availability of generics.

The Board’s Medical Director, Sir Bruce Keogh (pictured), said: “Variation in prescribing habits costs the NHS millions of pounds a year. Sharing of information will help clinicians understand whether they are over- or under-prescribing.

“This will focus minds in a way that will not only improve the quality of treatment for patients but also reduce cost and free up money for reinvestment.”

According to experts cited by The Independent, two mechanisms underlie the over-prescribing of brands: GP practices with on-site pharmacies have an incentive to prescribe branded drugs as they generate more profit; and hospitals buy branded drugs in bulk, reducing the cost but creating an ongoing patient expectation.

Open Health Care UK and Mastodon C will develop software to help the new CCGs target local GPs whose prescribing practices are expensive.

CCG leaders must become “demolition experts”, dismantling old services and commissioning new ones, the Chairman of the NHS Alliance has said.

At the pro-reform primary care organisation’s annual conference, Michael Dixon said the new NHS commissioners would achieve a definitive shift in healthcare towards community-based services.

Health secretary Jeremy Hunt also told the NHS Alliance that CCG leaders would achieve the “Holy Grail” of NHS care: the local integration of services.

In his keynote speech, Dixon said the new commissioners’ first task was “to enable redesign that has so persistently failed to materialise under the old order”, building new treatment and care structures in the community.

However, he noted, in the face of economic restrictions, service redesign alone would not be adequate; commissioners would need to “think ever bigger, wider, and more ambitious” in building partnerships with new providers.

The NHS Commissioning Board would need to act as the “grand protector” of CCGs against the “managerial hierarchy” of the old NHS, he argued.

Similarly, Hunt congratulated the new CCG leaders on having “won the argument for having an NHS which is driven by local decision-making and clinical leadership”.

As a result of that victory – which was, in fact, opposed by most clinicians – doctors would “see at a local level the integration of services that has been the Holy Grail for so many people”.

Hunt also praised the previous Government’s aim of creating a “single digital record” for all NHS patients, and said that such a system remained necessary – a notable shift in DH policy.

He promised that online appointments and repeat prescriptions would become standard, but said the viability of e-mail consultations was uncertain.

Finally, admitting that his role may have “a short shelf life”, Hunt reiterated his major goals for the NHS: improving dementia care, reducing mortality from major diseases, implementing new technology, and improving care as well as treatment.