The Government has revised its proposed regulations governing competition between NHS providers, following widespread protest from doctors.

The regulations, published a month ago, were criticised as removing the right of clinical commissioners to make decisions based on patient interests rather than the business rights of competing providers.

The amended version broadens the freedom of commissioners, stating that “integration” and “quality” are both valid reasons for not putting a service out to competitive tender.

However, the Royal College of General Practitioners (RCGP) has expressed concern that the new regulations, by virtue of their statutory nature, are imposing too many conditions on commissioners.

The aim of the new regulations was stated by the Government to be a replacement for the Secretary of State control abolished by the NHS reforms. In other words, having emphasised the “autonomy” of the new CCGs, the Government is imposing strict controls to defend the interests of the private sector.

The original secondary legislation, published in February, appeared to create a legal basis for the forced tendering of nearly all NHS services, enforced by Monitor.

A letter to the Daily Telegraph signed by more than 1,000 doctors urged MPs to force a debate on the new regulations, while the Academy of Medical Royal Colleges expressed concern that services would be disrupted by legal disputes.

Health Minister Lord Howe said: “It has never been and is absolutely not the Government’s intention to make all NHS services subject to competitive tendering or to force competition for services.”

New amendments to the regulations include:

• Commissioners are required to record how their decisions support the integration of services.

• Exceptions to competitive tendering include cases where avoiding competition leads to better quality or integration of services.

• Monitor no longer has the power to enforce competitive tendering.

The underlying purpose remains the same: to protect “patient choice” by ensuring that NHS commissioners have to put services out to tender unless they can justify not doing so in terms of better clinical outcomes.

The publication of the new secondary legislation coincides with that of a BMJ study stating that 40% of CCG board members have financial ties to private healthcare providers.

Clare Gerada, Chair of the RCGP, commented: “The revised regulations do not go far enough in ensuring that commissioners are genuinely free to decide whether or not to expose services to competition. Despite the revisions, they will still be required to show that there is only one capable provider in order to avoid having to put a service out to tender.”

The NHS Quality, Innovation, Productivity and Prevention (QIPP) programme has been broken down into its components following the resignation of its leader, Jim Easton.

The role of the former National Director for Improvement and Efficiency at the NHS Commissioning Board will be divided between four other national directors and SHA leader Sir Ian Carruthers.

Easton (pictured), who has left the NHS to head private health provider Care UK, warned in May that QIPP had become a ‘label’ for NHS spending cuts without service redesign.

Then changes mean that the QIPP programme will not have a specific team or individual leader to drive it forward.

According to the Health Service Journal, the decision not to replace Easton was made to reduce the Board’s running costs and because his role had been uniquely created for his skills.

Easton’s former responsibilities will be divided as follows. Sir Bruce Keogh’s medical directorate will be responsible for a new NHS improvement body, led by the five clinical domain directors. Bill McCarthy’s policy directorate will be responsible for strategy, including medium-term QIPP strategy. Jo-Anne Wass’s HR directorate will be responsible for the new Leadership Academy. Ian Dalton’s operations directorate will be responsible for productivity improvement.

In addition, NHS South West Chief Executive Sir Ian Carruthers will take over the leadership of NHS innovation.

Is QIPP really about ‘doing more with less’?

The NHS Quality, Innovation, Productivity and Prevention (QIPP) Challenge was launched in March 2010 as a strategy to facilitate major cost savings within the NHS, in response to the impact of the global recession. The principle of QIPP was that given the need for austerity budgeting, serious planning and rethinking were needed to ensure ‘smart’ cost-cutting that did not harm patient outcomes. The QIPP agenda was about identifying solutions that held together the four key principles, reducing overall costs by making interventions more timely, efficient and effective.

The new Government’s NHS reforms promised to facilitate QIPP by empowering local providers and commissioners to develop the best solutions for their communities. However, the economic pressures on CCGs and Foundation Trusts within the new system, combined with the ‘Nicholson challenge’ of cutting £5 billion out of the NHS budget in each of four successive years, have meant that the dominant theme of QIPP at a local level is cost reduction.

The first full year of QIPP (2011–12) delivered savings of £5.8 billion against a target of $5 billion. However, reports of NHS rationing and ‘postcode prescribing’ have proliferated. QIPP was devised as a strategy to combine two goals: the shift towards community-based healthcare and the urgent drive towards NHS cost-cutting. Is that still the agenda, or have the pressures of NHS reform reduced its four principles to one: reducing expenditure? Is QIPP really about “doing more with less”, as Andrew Lansley claimed, or is it just about doing with less?

A new healthcare paradigm
The DH booklet introducing the QIPP challenge in March 2010 set the context: “The NHS needs to identify £15–20 billion of efficiency savings by the end of 2013/14 that can be reinvested in the service to continue to deliver year on year quality improvements.” The booklet placed emphasis on improving quality while reducing overall costs through strategies such as early intervention, improved infection control and home-based care. Its authors included Jim Easton, then National Director for Improvement and Efficiency. The DH described a series of QIPP ‘workstreams’ it was setting up to help clinical teams and NHS organisations “improve quality and productivity across care pathways”. The first of these related to care of long-term conditions, urgent care and end-of-life care. Further workstreams would examine safety challenges, such as pressure ulcers (bedsores), and ‘right care’ issues such as referral management and identifying “low-value treatments” (later to become controversial issues).

The authors called for “a collective response at local, regional and national level” to address the QIPP priorities. These included early diagnosis, primary and secondary prevention and patient self-management. The need for “better partnerships between primary, community and secondary care to support people with long-term conditions” was emphasised. QIPP extended from the “daily clinical practice” of individual HCPs to “the wider care pathway”, the booklet said. Each SHA had its own QIPP lead and innovation lead, and was establishing an online regional ‘quality observatory’ and Innovation Fund to help clinical teams improve quality and productivity.

These ideas were illustrated by case studies where local NHS organisations had developed better and more affordable healthcare solutions. These included the use of an electronic system to ‘re-engineer’ blood transfusion, reducing waste and improving safety; and systematic guidance on antibiotic prescribing to reduce rates of C. difficile infection. These solutions all involved using teamwork and sharing information to make the best use of available resources.

The booklet ended on a warning note: “If we do not respond to this challenge there is a real risk that the need to cut costs will overtake our best intentions to improve care for our patients.” More than two years later, the crucial question is: has QIPP averted that outcome or brought it closer?

Innovation is ‘core activity’
In June 2012, Nicholson’s annual report claimed 2011/12 had been “a remarkable year” for the NHS. He highlighted the contribution of local initiatives to maintaining service quality while cutting costs. Austerity would dominate the NHS “for the foreseeable future”, he said. However, the innovation agenda promoted by the previous Government’s Office for Life Science and revived by the current Government in December 2011 would engage dynamically with that challenge: “Innovation has to... become the core activity of the NHS.”

His report went through the elements of QIPP, noting achievements in each area. Quality achievements highlighted included: in cancer care, the achievement of key treatment standards across all eight performance measures, as well as improved early detection figures; and in stroke care, better access to specialist stroke units and faster treatment of people with transient ischaemic attacks. Community-based asthma services in South East Essex were used as an example of a successful local initiative.

The brief section on innovation focused largely on the use of technologies in the community, including telehealth and home dialysis. The preventative care section emphasised the growing role of health visitors, and drew attention to the success of a national screening campaign for risk of venous thromboembolism (VTE) with prophylactic drug treatment given where needed.

In the productivity section, Nicholson noted QIPP savings of £5.8bn and praised the “modest reduction in activity levels” across the NHS – placing these in the context of the QIPP Long-term Condition Workstream, which aims to reduce unscheduled hospital admissions by 20%, reduce hospital stay length by 25%, and maximise the role of “supported care planning” in helping people to manage their own health. However, no reference was made to the rationing of procedures or the cuts in hospital nurse staffing.

Milestones or millstones?
A recent Health Service Journal report on the DH’s QIPP tracker indicates that the PCTs (soon to be abolished) plan savings worth £13bn nationwide between now and 2015, with £4.5bn of this to be achieved through the 53 local QIPP plans. The planned savings are front-loaded: £3.8bn this year and £3.6bn, £2.9bn and £2.6bn in the next three years. However, only £2bn of the planned QIPP savings are currently being achieved on schedule, and only six local QIPP plans are on track with all of their workstreams.

According to the tracker, productivity gains are the main objective of most local initiatives. Common features include the redesign of care pathways for long-term conditions, including diabetes and COPD, and the development of integrated care teams for dementia patients. However, many local plans have the single goal of reducing the cost of services – for example, South of Tyne and Wear PCT notes as an objective: “reduce price paid for Gateshead Health Foundation Trust older people’s mental health service”.

John Appleby, chief economist of the King’s Fund, commented that this emphasis on savings denied the original point of QIPP: “to improve value to patients”. He also said there was no evidence of the money saved being reinvested in future services, which was a key principle of the original QIPP agenda. The Audit Commission has since reported that the NHS has £4bn in “uncommitted finances”: cash reserves created by aggressive cost-cutting. Mike Farrar, Chief Executive of the NHS Confederation, has argued that this money needs to be invested in community and primary care.

Jim Easton, the NHS Commissioning Board’s Director of Improvement and Transformation, warned in July that too many NHS organisations were relying on spending cuts without any element of service redesign. The “deeper change” of shifting healthcare to the community was not being undertaken, he said, and
QIPP was becoming a “label” for “cost improvement plans”. As a result, the QIPP savings of the past year would be very difficult to repeat. Instead of building a new healthcare model, the NHS was just cutting
parts of the old one.

Easton has since announced that the Board will fund a new innovation body to deliver a “system-wide” response to the QIPP challenge. From April 2013, the new organisation will replace all existing NHS innovation and technology adoption bodies. He anticipates that it will “provide hands-on support for great models of care” developed within and beyond the healthcare sector. However, his resignation has cast a shadow over these plans.

According to the King’s Fund, 27 of 42 NHS finance directors it surveyed believe there is a high risk that the NHS will fail to meet the ‘Nicholson challenge’. A key question for industry, and for patients, is whether QIPP can help the NHS deliver on the more important challenge of transforming healthcare to meet the
changing needs of the population.

Joint working has been recognised as a driver of therapeutic innovation at the second annual Quality in Care (QiC) Diabetes awards.

Partnerships between Eli Lilly UK and NHS and voluntary sector organisations were commended in an event that stressed the contribution of cross-sector work to the QIPP agenda.

Held at Sanofi’s UK headquarters in Guildford, the QiC Diabetes awards highlighted innovation and good practice in UK diabetes care.

A partnership between Lilly and diabetes charity JDRF to develop an educational programme on type 1 diabetes for schools was highly commended in the Best Cross-Organisational Partnership category.

Lilly was also commended for its partnership with Royal Surrey County Hospital NHS Trust to develop the ‘Piecing Together Diabetes’ clinician training tool, a jigsaw that helps staff to improve inpatient diabetes care.

“The awards have provided a unique platform to showcase good practice and innovation from across the country,” said Anna Morton, Director of NHS Diabetes. “We are all working under increased pressure and uncertainty and the examples highlighted have shown how despite adversity, high-quality diabetes care can still be achieved.”

Caroline Horwood, diabetes division director at Sanofi, commented: “We witnessed some inspirational work last year, and it is heartening to see that 2012 brings some new award categories and a 50 per cent increase in the number of entries.”

Quality in Care is a series of programmes aimed at recognising good ideas for improving care quality and productivity, in line with the QIPP agenda, and sharing them across the NHS.

Portsmouth Hospitals Trust has taken steps to reduce its bed capacity, including the cancellation of its normal ‘winter’ increase, to improve its finances.

The foundation trust has seen its budget deficit increase due to “higher than expected” demand on beds driving increased use of temporary staff.

According to board papers for August, the trust has achieved its service delivery and quality targets only at the cost of financial failures.

All six of the trust’s financial indicators received a ‘red rating’, and the overall deficit (£5.9m) was £2.2m worse than had been planned.

The trust reported that “over-plan pay costs” due to “over-plan activity levels” were “only partially offset” by the increased income from that activity, with increased spend on temporary staff being the main problem factor.

It stated that the overall workforce “remains at levels that are not sustainable moving forward”.

The trust plans to reduce its temporary and permanent staffing costs through “actions to reduce bed capacity”, including “closing down ‘winter’ capacity”.

While the Portsmouth hospitals have achieved “improved or stable performance” against their service delivery and quality priorities, the board concluded that meeting clinical need was not viable.

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 Care Quality Commission has experienced “serious difficulties” in its first 18 months, according to a National Audit Office report.

The NAO said the regulator had “struggled” to fulfil its role due to NHS instability, making only half of the hospital inspections it had planned.

However the CQC was “now taking action to improve its performance”, the report concluded.

The new inspection body replaced the Healthcare Commission, the Commission for Social Care Inspection and the Mental Health Act Commission in October 2010.

The NAO noted that the abrupt shift had caused “disruption for providers and confusion for the public”.

By April 2011 the CQC had carried out only 53% of its planned inspections of hospitals and care homes, and had not met its schedule for registering care providers.

The organisation suffered from lack of staff, the review said: after a year, 14% of its positions – including 100 inspector posts – were unfilled due to Government restrictions on recruitment.

Its failure to identify patient mistreatment and neglect at a residential care home near Bristol was also criticised.

Both the DH and the CQC itself were to blame for the regulator’s failings, the NAO concluded.

Amyas Morse, head of the NAO, commented: “The CQC has had an uphill struggle to carry out its work effectively and has experienced serious difficulties. It is welcome that it is now taking action to improve its performance.

He added: “The commission and the Department of Health should make clear what successful regulation of this critical sector would look like.”

The DH is currently reviewing the CQC; its findings will be published later this year. Margaret Hodge, Chair of the House of Commons Public Accounts Committee, called the NAO’s report “deeply worrying”.

Innovative service redesign is enabling the NHS to meet the QIPP agenda of maintaining quality while cutting costs, Sir David Nicholson has said.

The NHS Chief Executive’s annual report highlights the contribution of locally-based initiatives to “a remarkable year for the NHS”.

Drawing attention to the Chancellor’s Autumn Statement, Nicholson said the issue of cost savings would dominate the NHS “for the foreseeable future”.

The report provides a summary of NHS achievements on five fronts: quality, innovation, productivity, prevention and transition.

Throughout, it uses examples of locally-based service redesign to illustrate clinical and economic improvement, including community-based asthma services in South-East Essex, COPD care in Surrey and stroke services in London.

Quality achievements highlighted include: the achievement of key cancer treatment standards across all eight performance measures, as well as improved early detection figures; and in stroke care, better access to specialist stroke units and faster treatment of people with transient ischaemic attacks.

Progress towards delivering the innovation agenda outlined by the Government in December 2011 is celebrated, with Nicholson commenting: “Innovation has... to become the core activity of the NHS; the way we do our business.”

QIPP savings of £5.8 billion are noted, including £1.9 billion in the last quarter alone. Nicholson praises the “modest reduction in activity levels”, but does not refer to the issues of NHS rationing or cuts in hospital nurse staffing.

Increased risk assessment for VTE, with prophylactic drug treatment given where needed, is highlighted as an example of progress in preventative care.

The section on NHS transition covers the development of the NHS Commissioning Board, the new CCGs and “a wider range of providers from across the NHS, private and voluntary sectors”. Nicholson emphasises the role of service redesign in making the transition a reality.

A report from the Department of Health shows that the NHS is on track to deliver up to £5.9bn savings this financial year, ahead of its annual target of £5bn cuts per year.

The Quarter 2 report claims that the NHS has maintained or improved the quality of services in eight key quality areas, including infection control.

However, the report does not acknowledge the impact of ‘red lists’ in rationing NHS treatments.

The report sets out NHS financial and quality performance from July to September 2011, and claims key quality successes:

• MRSA infections were reduced by 33% and C. difficile infections by 16% relative to the same quarter last year.

• The 18-week waiting time target continued to be achieved for 90% of inpatients and 95% of outpatients (though increases in waiting times have been reported by many NHS trusts).

• The NHS has continued to meet key cancer treatment standards.

The report predicts a year-end surplus for the NHS of about £1.2bn for 2011/12. PCTs estimate that they can achieve £5.9bn savings in this financial year – a major improvement on the £4.3bn saved last year.

The DH pointed to examples of local NHS initiatives to shift healthcare into the community and give patients more control over their own care, including:

• a home nursing service for children and young adults with asthma in South East Essex

• individual care plans for frequent ambulance callers developed in Kirklees for use by ambulance crews and A&E clinicians.

David Flory, Deputy Chief Executive of the NHS, commented: “The NHS is in the early stages of its plans to deliver up to £20bn of efficiency savings by 2014/15 whilst maintaining or improving quality. The results from the second quarter of 2011/12 are encouraging, showing the NHS continues to deliver strongly for patients while maintaining a healthy financial position.”

However, the health impact of the Audit Commission’s ‘red lists’ of drugs and procedures, restricting availability to the most severe cases, is not discussed in the report since outcome targets do not refer to care that is no longer provided.

A new report by the FDA highlights weaknesses in medical device quality in the US over the past decade.

The FDA’s report, Understanding Barriers to Medical Device Quality, stated that while revenues in the medical technology industry have grown over the last ten years, “serious adverse events” have outpaced this growth by 8% each year.

Failures in medical device design and manufacturing process control were found to account for more than half of all product recalls.

“While medical device flaws may vary by device, some sources of error are pervasive throughout the field,” the report reads.

“Identifying and addressing systemic barriers may yield improvements in medical device quality on a large scale.”

The report was launched by the FDA’s Center for Devices and Radiological Health in order to understand and improve gaps in device quality, and outlines recommendations for both industry and federal regulators.

The analysis found that “nearly 60% of the adverse event reports” involved cardiovascular, in vitro diagnostics and general hospital/surgical equipment.

“Our efforts revealed that there are systemic gaps within the medical device industry's quality approach that result in these issues,” said the report. “Attempts to improve quality are hindered by challenges within the industry as well as specific aspects of the agency's regulatory approach.”

According to the FDA, medtech manufacturers are facing a series of challenges which are impeding device quality, such as the increasing complexity of devices, time to market competition, and cost pressures.

Identified opportunities for improvement include postproduction monitoring and feedback, creating quality incentives, and improving design and engineering.

The report also cited steps for the FDA to incorporate, such as clarifying Agency requirements and learning from regulators of similar high-tech industries.

A similar initiative is underway in Europe to improve medical device regulatory assessment processes, with support from Eucomed.