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

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

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

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

 

A shared model

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

 

CCG development

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

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

The areas covered include:

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

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

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

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

 

Separating commissioning functions

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

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

 

Quality assurance

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

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

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

 

Budgets and responsibilities

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

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

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

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

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

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

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

 

The outside world

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

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

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

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

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

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

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

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

The idea that ‘any qualified provider’ can deliver NHS services may be contentious, but it has roots in existing policy. Thoreya Swage examines the opportunities for industry in the changing health provider landscape.

Successive governments have tried in recent years to shake up the healthcare system in the UK, with England probably being subject to the greatest number of changes. A key element of these shake-ups has been various attempts to expand the healthcare market in order to include the private or independent sector.

This widening of the doorway started in earnest with the deployment of the waiting list initiative in the 1990s, using the spare capacity of independent hospitals to reduce the queues for elective procedures that had built up in the NHS.

The baton was then taken up by the independent sector treatment programme under the last administration: the range of work done by private providers expanded to diagnostic procedures and screening programmes, as well as the construction of bespoke independent hospitals to take on hip, knee and cataract operations from the NHS.

It was at this stage that the concept of patients choosing which healthcare institution to go to for treatment or diagnostic procedures started to take off, with some of those options being in the independent sector. The idea of an ‘any willing provider’ began to take shape, with NHS care being delivered by any appropriate healthcare body as long as it had reached identified quality and safety standards.

However, before the recent change of government this initiative began to cool under external political pressure and at one time even seemed likely to fade away.

What AQP means

Despite opposition, the coalition Government has renewed the ‘any willing provider’ policy, calling it this time ‘any qualified provider’. In July of this year the Department of Health in England issued ‘operational guidance’ to the NHS providing further details to PCT clusters and the emerging Clinical Commissioning Groups (CCGs) – the renamed, modified GP consortia.

This policy has come under the guise of improving the quality of care by widening patient choice for specific services.

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

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

• musculo-skeletal services (neck and back pain)
• audiology services in the community (adults)
• continence care (adults and children)
• diagnostic services (e.g. imaging and heart and lung investigations)
• wheelchair services (children)
• podiatry services
• wound healing and management of leg ulcers
• primary care psychological therapies (adults).

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

Getting involved

How can independent provider organisations participate in this process? The principles of the AQP approach are as follows:

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

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

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

More details of the qualification process will be published this autumn.

The providers that have successfully achieved the national qualification process will be listed in a directory available to GPs later this year.

By November 2011, lead PCT clusters will have produced detailed implementation packs for each service on the AQP list that will include service specifications, contract currencies, tariffs and information models.

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

What happens next?

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

• maternity care, e.g. antenatal education and support for breastfeeding
• speech and language therapy
• supporting patients to self-manage long-term conditions
• chemotherapy in the community setting and at home
• primary care psychological therapies for children and adolescents
• wheelchair services (adults).

Opportunities for medtech

The most obvious opportunity for medtech in relation to AQP is in the sphere of direct access diagnostic services, where many investigations such as non-obstetric ultrasound, echocardiography, cardiac physiology, MRI, X-ray, endoscopy and phlebotomy can be provided in the community setting, as indeed some already are (e.g. via Inhealth). These direct referrals can enable GPs to obtain rapid investigations and help to manage their patients in primary care, without having to refer to a hospital consultant.

Another key area is adult hearing services, including audiology and hearing aid fitting. Telehealth and telecare also have a part to play in supporting some of these services by monitoring people with long-term conditions at home. The services identified for the initial phase of AQP have traditionally had poor information systems. Better data collection on activity and health outcomes will be vital for the success of the providers delivering services under this initiative.

The key challenge for medtech companies is to get onto the recognised list of AQP that the DH is drawing up, or to work with partners who will be applying to go onto the list. Rather than regarding independent providers simply as customers, medtech suppliers can work with them to achieve AQP success.

Potential providers need to get up to speed on a number of areas, such as ensuring that they are registered with the CQC, have a good understanding of the standard NHS contract, offer services in keeping with the CCGs’ requirements and can manage within NHS financial envelopes.

The aim should be to identify the lead commissioner(s) within the local PCT cluster and associated CCGs and find out which community services they are planning to include on their local AQP. Alternatively, contacting the local shadow health and wellbeing board (if it is sufficiently developed) may indicate other priority areas for AQP. This is an opportunity for marketing medtech services that can be shown to improve patient care and are aligned with the local health economy’s priorities.

Medtech providers should also be clear about whether they can meet (or help their partner organisations meet) the qualification requirements for AQP. They should look closely at the details of these when they are published by the DH later this year.

Companies should also start doing their homework now on pricing and the care outcomes that can be achieved through their services, bearing in mind that the NHS commissioners will be looking at how the five high-level domains of the NHS Outcomes Framework will be achieved.

Another key milestone to look out for is the implementation packs due in November on service specifications, contract currencies, tariffs and information models. These will require close examination by potential providers seeking to ensure that they are fully prepared for AQP.

Although this initiative seems small in scale it looks set to grow in the future, and further opportunities will present themselves for 2013 and beyond as AQP continues to expand. For more information, visit the Department of Health website.

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

Diabetes care specialist Novo Nordisk has launched a new type of insulin pen in the UK that allows injection at the touch of a button.

The FlexTouch disposable prefilled insulin pen is available with Novo Nordisk’s rapid-acting insulin analogue NovoRapid (insulin aspart).

The design of FlexTouch includes a spring that allows any insulin dose (from 1 to 80 units) to be injected by pressing a button.

In a survey, 3 out of 4 healthcare professionals rated FlexTouch as ‘very easy’ to use for injection of 20 units.

The device is prefilled with 300 units of NovoRapid insulin. The dose is adjustable in 1 unit increments up to 80 units.

Debbie Hicks, Nurse Consultant, Diabetes, Enfield Community Services BEH-MHT, commented: “This new device really does offer potential advantages to patients. Everyone benefits when the pen is simple and easy to use – patients, doctors and nurses educating the patients.

“It is really important that we continue to give our patients options in the way their treatment is delivered, so that this becomes as little an interruption to their life as we can make it.”

“We are very proud to make FlexTouch available to UK patients, as it is designed to benefit both patients living with diabetes and the healthcare professionals who are treating them,” said Viggo Birch, Managing Director of Novo Nordisk.

Based in in Denmark, Novo Nordisk is a global company that specialises in diabetes care, haemophilia care, growth hormone therapy and hormone replacement therapy.

The FlexTouch was granted approval by the European Commission in July 2011.

In response to the Independent Pharmacy Federation’s (IPF) survey, which noted Eli Lilly amongst the top three pharma companies to present the greatest difficulties in obtaining medicine supplies, a spokesperson for Lilly UK issued the below statement:

“Lilly is committed to ensuring that UK patients have access to our medicines and consequently distributes more than sufficient medicine to meet UK demand, through our direct to pharmacy distribution system.”

This is administered by two Logistic Services Providers (LSPs) and backed up by an emergency service; whereby a pharmacy can phone Lilly direct on our free phone number 0800 012 1178 and we will arrange a delivery at the next available opportunity – typically within 24 hours.”

Lilly UK is confident that our direct to pharmacy procedures provide a good and robust service to patients and pharmacists and adheres to the joint guidance: “Best Practice for Ensuring the Efficient Supply and Distribution of Medicines to Patients” and “Trading Medicines for Human Use: Shortages and Supply Chain Obligations”, issued by the Department of Health (DH).”

While we continually review and update our own procedures to ensure that every UK patient has access to our medicines, the difficulties experienced in providing consistent supply of medicines have been acknowledged by the DH as being caused - at least in part – by product diversion.”

For Lilly, one of our specific concerns is around the diversion of olanzapine (Zyprexa). This is likely to be a significant contributing factor in the IPF’s findings due to the impact these shortages have.”

We encourage the IPF to lend its support to driving adoption of the recent Department of Health guidelines and as well as sharing the results and methodology of its survey with us directly so that we may better understand their findings.”

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The FDA has approved Abbott’s stent system for the treatment of renal artery disease in patients with high blood pressure.

RX Herculink Elite is the first stent using cobalt chromium technology to gain a renal indication in the US.

Cobalt chromium allows for thin stent struts, which provides flexibility while maintaining strength to support the vessel and improves visibility during stent implantations enabling more accurate placement.

Michael R. Jaff, Medical Director of the Vascular Center and VasCore, at the Vascular Ultrasound Core Laboratory, Massachusetts General Hospital, Boston, said: “This result supports renal stenting as an important treatment option, as elevations in blood pressure can increase heart disease and stroke risk in patients with renal artery stenosis”.

The approval was based on Abbott’s HERCULES (Herculink Elite Cobalt Chromium Renal Stent Trial to Demonstrate Efficacy and Safety) study.

The study involved 202 patients with renal artery stenosis at 37 sites in the US, and demonstrated that the stent is safe and effective, with a significantly low restenosis (vessel re-narrowing) rate of 10.5% at nine months post-treatment.

HERCULES is a prospective study designed to evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in patients with atherosclerotic renal artery stenosis with uncontrolled hypertension.

Two unique handheld devices from a Welsh company that monitor the blood clotting status of patients are set for launch in the US.

The CoagMax (pictured) and CoagLite devices from Microvisk Technologies are a point of care test (for clinicians) and a home test (for patients) respectively to set the correct dosage of the anti-coagulation drug Warfarin.

The Microvisk devices, which have attracted strong interest from US distributors, are set to be trialled with 250 patients in Florida from October, with product launches scheduled for mid-2012.

In both devices a single-use SmartStrip with embedded sensors and a memory chip measures the clotting speed of blood from a fingerprick drop, and the results are displayed on a handheld reader.

The SmartStrip is based on Micro-Electro-Mechanical System (MEMS) technology, used in the iPhone and Nintendo Wii. This provides a more accurate result from a smaller blood sample than existing devices.

Multi-centre clinical trials of CoagMax and CoagLite are under way in the UK and Germany, where product launches are scheduled for early 2012. The devices will be showcased at Medica 2011 in November.

John Curtis, CEO of Microvisk, said: “We are delighted at the overwhelming interest shown by US distributors and potential partners in our CoagMax and CoagLite devices. We have been expanding our UK manufacturing facilities and are recruiting additional staff as we prepare for European product launches in early 2012.”

Microvisk has established a US operation in Florida. Bill Moffitt, the company’s US Chairman, commented: “These innovative devices will transform the way that blood testing is carried out, and Microvisk now has the opportunity to capture a substantial share of the market for doctor’s office and home tests for Warfarin patients.”

Over a million new patients each year use Warfarin to treat blood clotting disorders. They currently need regular blood tests at a surgery or clinic – but the Microvisk devices will enable them to test their blood clotting at home.

Based at St Asaph Business Park in North Wales, Microvisk specialises in medical testing devices based on MEMS technology.

NICE has published a proposed ‘menu’ of Quality and Outcomes Framework (QOF) indicators for 2012/2013.

The proposed list includes three new indicators for the support and treatment for smokers, two to assess physical activity, one for asthma, plus a set on fragility fractures in osteoporosis patients.

Christine Carson, Programme Director of NICE’s Centre for Clinical Practice, says the indicators have already been tested “to make sure they work”.

The Framework is a voluntary incentive scheme that rewards GP practices for improvements in the quality of care for patients.

Introduced in 2004, NICE took over the management of arranging the development and review of indicators in April 2009.

The Institute has recommended that 12 existing indicators be retired, including three for depression and two for diabetes, and also advised replacing a further four.

The selection of the final indicators for inclusion within the Framework will be decided by NHS Employers, on behalf of the UK health departments, and the General Practitioners Committee (GPC) of the British Medical Association (BMA) and published later in the year.

Siemens Healthcare has launched a ‘Guide to Low Dose’, together with educational courses, to complement its technologies for dose reduction in diagnostic and interventional radiology.

The Guide has been developed to help clinicians protect themselves and patients against unnecessary exposure.

In recent years, cumulative evidence of long-term harm to patients from excessive radiation exposure has made dose reduction a priority for all radiology suppliers.

Siemens Healthcare has already launched a range of diagnostic imaging technologies using X-rays or radioactive tracers that significantly reduce doses without affecting image quality. The company’s Combined Applications to Reduce Exposure (CARE) portfolio includes technologies for the reconstruction of CT and PET images; automatic selection of the most appropriate KV setting for the patient and type of examination; and software to help clinicians optimise scan protocols at reduced dose levels.

In addition, all new Siemens imaging equipment will issue warning messages to users if a dose threshold is exceeded in critical applications.

“Siemens has pioneered the development of dose reduction technologies for many years,” said Russell Lodge, CT Business Manager at Siemens Healthcare. “With a solid product portfolio that focuses on speed, image quality and low dose, we need to ensure that there is a good level of education inside the health environment.

“Training sessions and education literature is a way to cement our commitment to our customers and keep them fully up-to-date with the extensive functionality we offer.”

 
Siemens Healthcare’s ‘Guide to Low Dose’