The Care Quality Commission (CQC) was formed in 2009 to replace three separate inspection bodies: the Healthcare Commission, the Commission for Social Care Inspection and the Mental Health Act Commission. Since October 2010 all providers of healthcare and social care, whether in the public or private sector, have had to register with the CQC – which now regulates more than 21,000 providers.

This massive registration task was divided into phases: the Commission registered NHS secondary care providers, then re-registered adult social care and independent healthcare providers, then registered primary dental care and independent ambulance providers. Its next challenge is to register all GP practices. Most importantly, it will need to continue monitoring the quality and safety of all these providers’ services.

The CQC’s declared purpose is to eliminate poor quality care, defend patients’ rights and ensure that care is centred on people’s needs. Initially it adopted a ‘risk-based’ strategy of using evidence of potential danger to determine the frequency of inspections. In 2011/12 it shifted to annual inspection of all care providers. Next year, however, it will revert to a ‘riskbased’ approach – as well as participating in local Quality Surveillance Groups, alongside CCGs and local Healthwatch.

These changes follow a year in which the CQC has faced criticism of its leadership and its overall performance. The Mid Staffordshire Foundation Trust enquiry led to criticism (for different reasons) of its Chief Executive, Cynthia Bower, and its Chair, Dame Jo Williams. The recent scandal of sustained patient abuse at Winterbourne View Care Home led the CQC to be accused of failing to conduct regular inspections and respond to ‘whistleblowers’.

In March a Commons Public Accounts Committee concluded that the CQC had “a long way to go” before it could be considered an effective regulator. The recent resignations of Bower and Williams have reduced the shadow over the leadership. The new CQC Chief Executive, David Behan, has a background in social care rather than healthcare. But can the problems of regulating provider quality in the new health and social care system be solved by such changes, or are they systemic issues beyond the scope of the CQC?

In safe hands
The CQC’s annual report for 2010/11 noted that by April 2010 it had licensed all 378 NHS provider trusts, and had required 22 trusts to take specific actions to improve their services. By October 2010 it had re-registered 12,000 adult social care and independent health providers, and had required almost 1,000 care homes to put in place qualified managers. By July 2011 it had registered 18,000 dental care and independent ambulance providers. The inclusion of primary medical services will add 8,000 providers to the list.

Each provider is accountable for each separate ‘regulated activity’ it provides, and must show that the service meets acceptable standards of quality and safety. CQC standards cover these areas:

• Informing patients and involving them in decisions about their care.
• Personalised care, treatment and support.
• Safeguarding and safety of the care environment.
• Suitably qualified and capable management and staff .
• Risk management and incident reporting.

A further responsibility of the CQC is to respond to complaints about services – and in particular, to provide a safe and responsive port of call for ‘whistleblowers’: care provider staff who report failings in quality or safety.

Winter in social care
Financial pressure was a feature of the CQC’s role from the outset. Its initial budget was 30% less than the combined budget of the three organisations it had replaced. The Labour Government set a ‘light-touch’ agenda for inspection: unless there was evidence of risk, providers would be left uninspected for
up to two years.

The coalition Government’s review of arm’s length bodies in July 2010 reinforced the CQC’s role as regulator for health and social care. However, it was not exempt from the general requirement that the NHS ‘do more with less’. Its annual budget for 2010/11 was set at £16.4m – £10m less than it had told the DH it needed to cope with the combined task of registering and inspection.

As a result, the number of inspections carried out by the CQC fell by 70%. Concern over its performance came to a head in the Winterbourne View scandal, where action to stop the mistreatment of learning-disabled patients in a care home run by private firm Castlebeck had been unacceptably slow. The regulator had failed to act on information from a ‘whistleblower’, and only a BBC Panorama report had brought the abuses to public attention.

In the aftermath of the scandal, a Health Select Committee report accused the CQC of devoting too much of its resources to registration, a sign of “distorted priorities”. However, Kings Fund Director of Policy Anna Dixon observed: “It is no good preaching the virtues of light touch regulation, and then blaming the regulator for not taking a more interventionist approach when problems emerge.”

The later Commons Public Accounts Committee report highlighted several CQC failings: lack of inspections,
failure to fill key vacancies in its inspection team, and the decision to scrap a helpline for whistleblowers. The committee said the CQC risked becoming a mere “postbox” for complaints.

Jo Williams described the Winterbourne View case as a “watershed moment” for the CQC, triggering its abandonment of the ‘light touch’ approach. The regulator asked for – and got – a £10m increase in its budget for 2012/13 to increase its number of inspectors by 15%, enabling it to adopt a policy of inspecting each provider at least once a year.

Crisis of leadership
The issues affecting the CQC leadership reflect some of the conflicts of interest that can arise for care regulators. The Mid Staffordshire inquiry – the greatest hospital safety scandal in the NHS’s history – concerned events that took place before the formation of the CQC. However, Cynthia Bower was head of the West Midlands SHA at that time, and the inquiry was critical of her role.

The Healthcare Commission (HCC) had warned the SHA about the unusually high mortality rate at Stafford General Hospital. According to the Guardian, Bower responded by commissioning a known critic of the HCC at Birmingham University to write a report on the HCC’s methodology. When the CQC was formed, Bower disbanded the HCC’s inspection team.

The Mid Staffs inquiry led to severe damage within the CQC. Senior operations analyst Rona Bryce claimed the testimony of CQC Board members was “aspirational”. Board member Kay Sheldon contacted the enquiry to voice concerns she said she had raised internally without result. Dame Jo Williams then asked the Health Secretary to dismiss Sheldon, but he declined. Williams also commissioned a third-party investigation of Sheldon’s mental health.

The way forward
David Behan, who took over as CQC Chief Executive in July 2012, had been Director General of Social Care at the DH since 2006. His appointment suggests a shift towards greater focus on social care regulation. The DH has set three core goals for the CQC going forward: to become more strategic in its approach and define quality more clearly in terms of outcomes; to make its Board stronger and more accountable; and to make the regulatory process more systematic and proportionate to risk.

The reversion to a risk-based approach is clearly driven by the cost-cutting agenda. However, Behan promises a “more ambitious” use of performance data to highlight success as well as failure, helping to drive widespread improvements in care. He also plans a “differentiated regulation” of health, mental health and social care providers.

In addition, from April 2013 the CQC will work alongside CCGs and local Healthwatch to develop a network of local and regional Quality Surveillance Groups. According to the NHS Commissioning Board, this system will “act as a virtual team” across health and social care, and will “need to manage itself ” without governance. It will use a ‘risk summit’ model to deal with problems, but who takes primary responsibility will depend on the circumstances.

These changes show the CQC becoming more devolved, but also more able to assist the integration of health and social care. However, as providers become more diverse while funding both for inspection and for care becomes steadily tighter, the future is unlikely to be problem-free for the regulator. The CQC will need to continue walking a tightrope between a ‘light touch’ agenda and urgent reactions to healthcare disasters – its success will depend primarily on getting better at it.

The NHS needs to involve the general public in making important decisions when managing their care and encourage greater interaction in their health and wellbeing, the NHS Confederation has said.

Mike Farrar, Chief Executive of the Confederation, said the NHS needs to go further to meet statements in its constitution to combat future challenges.

Farrar, writing in an editorial in The Guardian, said “NHS organisations need to do more to involve patients and the public” in how services are run.

The NHS Confed leader referred to the statement in the NHS Constitution that: the NHS belongs to the people.

But he admitted that the “daily reality for patients and the public” is somewhat different – and highlighted poor clinical practice and senior NHS leaders ignoring public opinion when making difficult decisions.

He said: “Take all this into account and you sense the NHS is a ‘public service’ with a long way to go.” Farrar added that the solution must change rapidly if the “NHS is to survive its next decade of challenges.”

Farrar pointed towards greater patient engagement in the future to obtain “faster and more sustainable results.” He said this was “business critical” if the NHS is to provide better standards of care and outcomes “for less money as healthcare demands grow”.

“There is no doubt that healthcare issues are complex,” he said. “But NHS managers and doctors do themselves no favours by their attitude of ‘arms around their work, no peeking’. We have to change.

“There is a huge need for more transparency, honesty and openness about why we need to modernise health services. There is an even bigger need for revealing to the public information about the economics, finances, and costs of health and social care.”

The £2bn gap in long-term social care funding will have a detrimental effect on NHS services, a new report by the NHS Confederation has predicted.

The report, Papering over the cracks, suggests that a failure to resolve the funding issue will have a severe impact on patients as more people require services.

Jo Webber, NHS Confederation Deputy Director of Policy, said the NHS “cannot keep on picking up the pieces of a broken social care system.”

The NHS Confed has now called for a cross-party political consensus to address the immediate cash surplus and find a long-term funding solution.

If a solution is not found, the Confederation warns that even basic social care services which are currently provided may not be available in the future.

The report advises that the health and social care system must respond to the needs of a population where people are living longer with long-term conditions. It found that more people are accessing NHS services due to cuts in social care, and that funds allocated to transform services have been used to ‘paper over the cracks’ in the social care system.

At a time when the NHS is being asked to find £5bn of efficiency savings, the report adds that it is not sustainable for the health service to continue covering the social care funding gap.

“The NHS and our local authority colleagues need to look at how we can radically redesign care and be more innovative in the way we integrate services for people with care needs,” said Jo Webber.

“We cannot solve this problem on our own. Increased funding is a key part of this solution. Without the involvement of the Treasury, including a clear outline of how we will address long-term social care funding in the next Spending Review, we will see a decline in services and greater pressure building on the NHS.”

The NHS Confederation backed the short term transfer of NHS funds to support local social care services. But it added that a continued policy of “robbing Peter to pay Paul would be very short sighted.”

Spending on healthcare is set to soar over the next 50 years despite NHS efficiency measures, a new report predicts.

The Office of Budget Responsibility’s Fiscal Sustainability Report forecasts increased costs will result in a 5.2% rise in public spending on healthcare – the equivalent of £80bn in today’s terms.

A hike in the proportion of the population aged 65 and over is highlighted in the report, as are additional costs required to cover social care and pensions.

Report authors say the findings should not result in “a bigger tightening” of NHS purse strings but ministers should “think carefully” about long-term consequences resulting from short-term policies.

Health spending will rise from 17% today to 26% in 2061, the report found. As a consequence, the government will need to increase tax rates to generate £17bn in funds or make major spending cuts to reverse levels of debt, the report said.

The report also forecast an improvement in the efficiency of the NHS. Spending will rise from 6.8% of gross domestic product (GDP) in 2016-17 to 9.1% over the next half century. The report bases this on NHS productivity increasing by 2.2% annually. However, if healthcare productivity grows less quickly at 0.8%, as certain experts predict, spending levels may increase to around 16.5% and see a steep rise in public sector debt.

Seven medical devices, diagnostics and healthcare IT have been named in Cleveland Clinic’s Top 10 Medical Innovations for 2012.

The list of medical devices and therapies was chosen by a panel of physicians and scientists at Cleveland Clinic, named one of “America’s Best Hospitals” by the US News & World Report survey.

The annual list recognises new techniques, therapies and approaches to treat medical conditions.

The selection criteria for qualifying in the Top 10 Medical Innovations required nominations to:

• Have significant potential for short-term clinical impact (either a major improvement in patient benefit or an improved function that enhances healthcare delivery)
• Have a high probability of success
• Be on the market or close to being introduced
• Have sufficient data available to support its nomination.

The Top 10 Medical Innovations for 2012 are:

10. Genetically Modified Mosquitoes to Reduce Disease Threat

9. Novel Diabetes Therapy: SGLT2 Inhibitors

8. Harnessing Big Data to Improve Health Care – Health care data requires advanced technologies to efficiently process it. Analytics can be applied to better hospital operations and tracking outcomes for clinical and surgical procedures.

7. Active Bionic Prosthesis: Wearable Robotic Devices

6. Implantable Device to Treat Complex Brain Aneurysms

5. Increasing Discovery with Next-Generation Gene Sequencing

4. Medical Apps for Mobile Devices

3. Concussion Management System for Athletes – Patient management tools can instantly detect brain injuries at the moment of contact.

2. CT Scans for Early Detection of Lung Cancer

1. Catheter-Based Renal Denervation to Control Resistant Hypertension

Cleveland Clinic is a non-profit academic medical centre that integrates clinical and hospital care with research and education.

A portable, non-invasive acoustic device now available in the UK can provide sustainable long-term relief from the symptoms of tinnitus.

UK patients whose symptoms have been relieved by the Acoustic CR Neuromodulation device from ANM include a retired labourer who had suffered from tinnitus for 20 years.

Available exclusively in the UK from Harley Street centre The Tinnitus Clinic, the therapy targets the auditory centre of the brain to inactivate the hyperactive nerve cells causing the symptoms.

Long-term tinnitus sufferer Peter Humphries experienced symptom relief within 10 days after receiving treatment with Acoustic CR Neuromodulation.

He commented: “I’m amazed to find that the treatment is working. I first noticed a change after about 10 days. Since then, there’s been a noticeable change every couple of days as my tinnitus starts to disappear.”

Acoustic CR Neuromodulation was developed in Germany and is sold by Adaptive Neuromodulation (ANM) in Cologne.

The Tinnitus Clinic, part of the Brook Henderson Group of independent healthcare providers, has signed an exclusive UK distribution agreement with ANM for this technology.

According to current neurological theory, tinnitus is caused by acoustic nerve cells misfiring together. Acoustic CR Neuromodulation disrupts these pathological signals by transmitting a patient-specific set of tones to the patient’s auditory cortex.

The portable device combines a matchbox-sized acoustic transmitter with small medical earphones. Patients wear the device for 4–6 hours per day while engaged in normal activities. Over 6–12 months the acoustic signal is fine-tuned in line with the changing symptoms.

In clinical trials, Acoustic CR Neuromodulation reduced tinnitus symptoms in 7 out of 10 patients over 9 months.

Jazz Pharmaceuticals and Irish-based Azur Pharma Limited have combined to create a new speciality company.

The combined company – which will continue as Jazz Pharmaceuticals plc– will be incorporated in Ireland and has several products currently marketed in the US.

Seamus Mulligan, Chairman and CEO, Azur Pharma, says the merger creates a company that has “greater operational and financial resources” to enable its strategy of acquiring and developing speciality products.

The company markets ten products in the US within the central nervous system (CNS) and women’s health areas. Including Xyrem, Luvox CR, Prialt, FazaClo and Elestrin, revenues are now expected to reach more than $475 million in the first 12 months following the completion of the deal.

The combined company would also have a number of pipeline of lower-risk development programmes, including line extensions for the clozapine franchise and various other branded women’s health products.

"This significant transaction represents a compelling strategic fit, given our companies' closely aligned missions of identifying and developing products that address unmet patient needs and can be efficiently marketed through a specialty commercial infrastructure," said Bruce Cozadd, who will become the Chairman and CEO of Jazz Pharmaceuticals plc.

Sanofi Pasteur is donating a vaccine strain used for polio eradication to the World Health Organization (WHO) to produce oral polio vaccines (OPV).

The vaccines division of Sanofi is providing the original viral seed which is used to produce large volumes of OPV against the type 3 virus.

Olivier Charmeil, President and CEO of Sanofi Pasteur, says the donation is a “logical next step” in the division’s “unconditional support to OPV producers”.

Since its inception in 1988 by WHO, Rotary International, the US Centers for Disease Control and Prevention (CDC) and UNICEF, the Global Polio Eradication Initiative reduced the number of polio cases across the globe by 99%.

Sanofi Pasteur has supported the Initiative for the last three decades and recently responded to a request from UNICEF by committing to provide 400 million doses of OPV for use in developing countries. The donation saw the amount of doses provided by Sanofi Pasteur exceed five billion doses of OPV to UNICEF.

“Sanofi Pasteur is a leading contributor to the fight against polio and committed supporter of the Global Polio Eradication Initiative," added Sanofi Pasteur’s President.

WHO will now be in full control of the storage of the vaccine strain and its distribution to vaccine producers across the globe.

Boehringer Ingelheim and Eli Lilly have launched Trajenta (linagliptin), a single dose, once-daily tablet for adults with type II diabetes mellitus (T2DM) in the UK.

Trajenta has been shown to deliver significant HbA1c reductions compared to placebo and was generally well tolerated in clinical trials involving more than 4,000 patients.

Professor Anthony Barnett, Consultant Physician and Emeritus Professor of Medicine, Heart of England NHS Foundation Trust and University of Birmingham, says its release is “an important advance in the management” of diabetes.

The drug is licensed for adults with T2MD as a monotherapy in patients inadequately controlled by diet and exercise alone, and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

It is also licensed in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; and in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

In clinical trials, a mean HbA1c reduction from baseline of 0.7% was sustained over 102 weeks as add on to metformin and a sulphonylurea in patients using Trajenta.

Around a third of people with diabetes are affected by chronic kidney disease. The convenient tablet is the only dipeptidyl peptidase-4 (DDP-4) inhibitor which is primarily excreted via the bile, and the first in this class licensed for use in T2DM, irrespective of degree of renal impairment.

“Linagliptin offers the benefits of the DPP-4 inhibitor class with good tolerability, weight neutrality and low risk of hypoglycaemia and the additional advantage of health professionals being able to prescribe without dose adjustment irrespective of the patient's renal function,” added Professor Anthony Barnett. “Renal impairment is common in people with type 2 diabetes so this latter point is extremely important.”

A convenient oral treatment patients can take at home to prevent venous thromboembolic events (VTE) following elective total hip or knee replacement surgery is now available in the UK.

Eliquis (apixaban) has been launched through a collaboration between Bristol-Myers Squibb and Pfizer and could help prevent up to 25,000 deaths each year resulting from blood clots.

Dr Ander Cohen, Honorary Consultant Vascular Physician at King's College Hospital, London, says the treatment “represents a new option” for surgeons in the UK.

VTE can lead to two serious conditions: deep vein thrombosis and pulmonary embolism which can lead to death if not treated.

The license of Eliquis is based on the ADVANCE-2 and ADVANCE-3 clinical trials in patients who underwent elective total hip or knee replacements. More than 8,000 patients were assessed during the trials which assessed the efficacy in preventing blood clots and death, and bleeding risk of Eliquis when compared to enoxaparin.

“Clinical data showed that apixaban was more effective than the anticoagulant enoxaparin and importantly, it also showed no increase in bleeding rates compared to enoxaparin,” said Dr Cohen.

Dr Rick Lones, UK Executive Medical Director, BMS, said the two companies “hope to reduce the burden of blood clots” in patients undergoing major surgery after the drug’s release in the UK.