The 2009 Health Bill

pharmafile | March 27, 2009 | Feature | |  2009, Darzi, NHS, health bill, healthcare 

The 2009 Health Bill is the latest major piece of legislation aimed at transforming the NHS, and introduces a range of new measures to make it a more patient-centred health service.

The Health Bill is designed to realise Lord Darzi's vision for the service – 'High Quality Care for All', published in June 2008, which set out a new 10-year plan for the NHS in England.

Launching the Bill, health secretary Alan Johnson said: "People rightly have high expectations of the care the NHS offers, and they want more control over their own health – which is why this Bill will give more power to patients and drive up the quality of care."

The essence of the Bill is contained in a triumvirate of new initiatives:

NHS constitution: This enshrines the rights of patients to good quality care. Providers and commissioners of NHS services are obliged to take it into consideration in their practices.

Quality accounts: NHS bodies will have to publish 'quality accounts'. These will shift the emphasis away from hitting waiting list targets and non-clinical measures towards measuring the quality of care given to patients.

Personal budgets: Proposals to pilot direct payments to patients for health services, to give them greater control over the healthcare services they receive. These are an interesting range of initiatives, and could eventually transform the way the NHS operates.

Steve Barnett, chief executive of the NHS Confederation, responded to the signing of the NHS constitution by the prime minister in January, saying it provided a framework for the NHS to "become a world class health system for the 21st Century, and we should all be looking to surpass the standards it sets."

He continued: "The ultimate test will be to prove that it makes a difference to the experience of all patients and staff.

"There are areas, like rights to drugs and the environmental sustainability of the NHS, where the constitution may need to be more specific in the future and that process of evolution is one the whole health service will need to be involved in.

"The constitution's inclusion of rights for members of the public to choose their GP practice and a specific doctor within that practice will be welcome news for patients. However, it will have repercussions for Primary Care Trusts and doctors' practices, and the appropriate funding and staff levels will need to be in place to ensure that this can be made to work."

So those are the implications for patients and NHS professionals, but what about the pharmaceutical industry?

The Health Bill certainly represents yet another health service policy development to keep abreast of and make sense of in a pharma industry context – something which is not easy to do when many of its parameters are not yet fixed. But it is clear that it represents a continuation of the drive towards a greater patient focus, and in that way could provide oppportunities for partnerships with the NHS for those companies willing to engage at an early stage.

The new NHS constitution

The NHS constitution was a centrepiece of the Darzi review and was drafted in time to mark last year's 60th anniversary of the NHS.

The constitution does not contain any new patient 'rights' as such, but does bring together for the first time in one place what staff, patients and the public can expect from the NHS. Aimed at providing greater transparency and clarity, particularly for patients, it redefines the purpose and values of the NHS and is underpinned by seven key principles. It brings together a number of rights, pledges and responsibilities for staff and patients, including the expectation that patients will receive (largely) free healthcare and the right to be treated professionally and with dignity and respect. It also enshrines the right for patients to seek care abroad when they face undue delay.

Other patient rights and pledges in the constitution include:

* The right to drugs and treatments recommended by NICE (if the patient's doctor believes these are clinically appropriate)

* The right to expect local decisions on funding of drugs and treatments to be made rationally following proper consideration of the evidence, and for any negative decisions to be explained

* From 1 April 2009, the right to receive vaccinations that the Joint Committee on Vaccinations and Immunisation recommends under an NHS-provided immunisation programme

* And, for the first time, an explicit pledge to fund screening programmes

When it was published in January, the constitution got a mixed response from the media, and critics argue it offers little new over the Patients' Charter, introduced by the Conservative government in the early 1990s. The Liberal Democrat health spokesman Norman Lamb, for example, commented: "This was a missed opportunity to introduce real guarantees for patients on waiting times and access and make the NHS more accountable to the people it serves."

Nonetheless, there now exists a single document where basic rights are set out in a largely patient-friendly and digestible form.

The constitution was launched with a (considerably longer) handbook to the NHS Constitution, which provides details including the legal basis for each of the stated patient rights.

Simultaneously, the National Prescribing Centre on behalf of the Department of Health, published its guiding principles to improve the consistency and quality of local decision making on medicines. This relates to the constitution's principle that patients have the right to expect local decisions about funding of treatments to be made rationally, using a common framework and following proper consideration of the evidence.

The nine guiding principles address governance and accountability, procedures, criteria for decision making, documentation, timelines, the appeals process, local engagement, and implementation and process improvement. A supporting NPC Handbook including good practice guidance and resources is is now available (see box opposite) and is set to be a key resource for PCTs.

Progress has to be monitored by the Secretary of State, who is expected to review the effect of the constitution on patients, staff and the public and must publish a report every three years (with the first expected no later than July 2012).

Aiming for quality

Lord Darzi put the spotlight firmly on quality. 'High Quality Care for All' aims to make better quality care the organising principle behind the NHS. The Bill seeks to make it the duty of health providers to produce quality accounts, just as they currently produce financial accounts. These will include public reports of their achievements, indicators such as patient safety, experience and outcomes. This means that quality accounts can then be used to benchmark performance between service providers across England.

Quality accounts are currently planned for publication by 30 June 2010 following the end of the NHS 2009/10 financial year. Quality accounts will contain information for the benefit of patients, clinicians and managers, the aim of which will be to inform local accountability for services, and to assist clinicians, commissioners and patients in driving improvements.

Exactly what quality accounts will include has yet to be clearly defined. Service providers were asked to suggest measures to be included in quality accounts, and in November around 400 potential indicators of quality were put online for consultation. The first half of 2009 will see 'consultative events' with stakeholders to further shape development, which will run in parallel with the legislative process. The final decision on what will be included in the quality accounts is expected to be decided in secondary legislation – the regulations and guidance expected later this year. This wait allows more opportunity for further deliberation on what should be measured and how.

Early thinking is that the greater proportion of each quality account should relate to measurement against local strategic priorities, while the remainder will include a core set of data that will be collected by all organisations to enable country-wide comparisons. If this flexibility is adopted, this means that quality accounts will vary from trust to trust. The nationally consistent information in all quality accounts is likely to include:

* Information on quality that providers supply to the Care Quality Commission for performance assessment and registration purposes

* Information on quality indicators that a provider may need to supply to their PCT under the contract they have with them, including any information they need to supply to their PCT for the proposed new Commissioning for Quality and Innovation (CQUIN) scheme (another Darzi initiative)

* Information that providers have supplied to cancer networks or in respect of clinical audits

During the second half of 2009, pilot quality accounts will be developed with input from Monitor, the independent regulator of NHS trusts. It is very much a case of watching how these develop, as the devil is, as always, in the detail.

A key question for NHS managers yet to be answered is how to respond when a service is found to be below expectation. Trusts have shown that they are able to improve waiting times and financial performance, and are now considering quality improvement strategies to enable their directors and teams to reform services to improve quality, safety and patient experience.

This developing picture seems to hold potential for industry involvement. For the pharma industry, helping its customers develop the new skills sets required might be a service it can usefully provide, for example through NHS and industry joint working.

There has rightly been a lot of interest in quality accounts from the industry. It plays to pharma's strengths – the industry has been talking about quality of outcomes beyond safety and efficacy for years. And as effective businesses pharma needs to know about customer satisfaction and quality. The whole quality agenda is therefore a major opportunity.

Personal health budgets

The Health Bill also sets out the framework for piloting cash payments, so-called 'healthcare direct payments'. Personal budgets sit within a spectrum of policies aimed at personalising the NHS, which includes choice and care planning. Personal health budgets are aimed at empowering patients, and thereby helping them to manage their own health and conditions.

This is an attempt to replicate successes that have been achieved in social care services, where there is growing experience in promoting personalised care services. It also draws on other health schemes including the US Medicaid system and the NHS in Scotland, which has the power to include funding for community healthcare services in individual budgets alongside other funding streams.

But it is important to remember that cash payment is only one of the patient-specific budget choices. PCTs already have extensive powers to offer personal health budgets and there already exist two basic ways of providing patient-directed funding. First there is the option of a notional budget held by the commissioner, where patients are aware of the treatment options (within a budget) and of the financial implications of their choices. The NHS underwrites overall costs and all contracting and service co-ordination functions. The second existing option is for a real personal budget managed on the individual's behalf by a third party (e.g. a GP, care co-ordinator or patient advocate). The intermediary helps the patient choose services within their personal budget allowance.

The proposed legislation would enable this to go one step further and allow direct funding to some patients to purchase their own services. Long-term conditions, mental health services, substance misuse, maternity services, and those receiving NHS continuing healthcare are most likely to be among the first to benefit from the new facility. Pharma companies with an interest in these areas will need to keep a close eye on the development of personal budgets to make the most of any opportunities arising.

'Personal Health Budgets: First Steps'

This was the name of the document published in January which sets out the conclusions reached after the stakeholder engagement programme that followed the launch of the Darzi report. Expressions of interest in the pilot programme were also invited, with responses required by the end of March. The pilots that are going ahead in the nationally co-ordinated programme will be announced shortly. These won't begin until after the Bill's Royal Assent in the summer, and in reality the pilots aren't expected to get going until 2010, with the programme expected to last for three years.

Exactly who would get cash payments, in what circumstances, and how they will be paid has all yet to be worked out. The intervening three-year period will allow time to increase experience of existing personal budget models and put the necessary systems in place, before tackling the challenge of administering direct payments to patients.

Interestingly, one of the aims of personal budgets is to support the cultural change Darzi believes is needed to create a more personalised NHS. While only a relatively small number of patients would have needs appropriate to a personal health budget, let alone receive a direct cash payment, the expectation is that their impact on the way care is delivered could be much wider. The focus on personalisation is expected to encourage clinicians and care co-ordinators to have better informed discussions with individuals and families and to think holistically about the patient's needs.

The 2009 Health Bill is expected to be approved by the summer, and with such an interesting selection of initiatives it is well worth watching progress intently. For industry, the focus on quality, rather than process, as the priority for the NHS can only be welcome, providing companies with renewed opportunities to emphasise how their medicines will improve patient outcomes.

PRINCIPLES UNDERPINNING PERSONAL HEALTH BUDGETS:

* Uphold NHS values as set out in the Constitution and which should remain consistent with existing NHS policy

* There should be clear accountability for the choices made

* No one will be denied essential treatment as a result of having a personal health budget

* A PHB does not entitle someone to more expensive services, or preferential access to services

* There should be good and appropriate use of NHS resources

* Safeguard and improve quality (safety, effectiveness and experience)

* Tackle inequalities and protect equality

* Be purely patient voluntary

* Make decisions as close as possible to the patient ( personal support to be available particularly for those least well served by existing services); and

* Work in partnership (individuals working with their families, carers and professionals, and PCTs, local authorities and healthcare providers).

SUPPORTING RATIONAL LOCAL DECISION-MAKING ABOUT MEDICINES

The National Prescribing Centre published its handbook for Supporting Rational Local Decision-Making about Medicines (and treatments) in February.

The document has been produced as guidance to PCTs in response to controversy around postcode prescribing, and particular the work of 'exceptional circumstances' committees, which rule on whether or not to fund drugs before NICE has appraised them.

It also reflects the new NHS constitution which includes the "right to expect local decisions on funding of drugs and treatments to be made rationally following proper consideration of the evidence, and for any negative decisions to be explained".

Read the full document here.

Beverley Evans is a partner in the market access specialist consultancy Policy Matters. Beverley.Evans@policy-matters.com .