The passing of the Health and Social Care Act 2012 ("HASCA") in the UK ushered in a wave of systemic reforms of the English NHS and its commissioning processes, the effects of which are now beginning to be seen. At the same time, there has been much talk of the fact that the English NHS is currently in a state of financial crisis.
Regardless of its financial difficulties, as a public body the English NHS is subject to English public law duties when exercising its decision-making powers. This article provides a brief summary of the structural reforms in the English NHS's commissioning framework and a list of top tips for healthcare organisations seeking to navigate the new commissioning processes and ensure they are being treated lawfully.
The key message is this: if you believe the English NHS is acting unlawfully, take legal advice, because informed correspondence about the unlawfulness of a proposed decision may be exactly what you need to get you the right result.
Summary of Reforms
The Commissioning Process
Under the new system, the majority of English NHS commissioning is handled by 211 Clinical Commissioning Groups ("CCGs"). CCGs replaced primary care trusts in England in March 2012 and are the organisations that manage the delivery of many NHS services in England. Each CCG is responsible for a specific geographic area. CCGs reimburse NHS healthcare providers (such as hospitals and GP surgeries) for administering a healthcare service to a patient. In most cases, the price paid to the provider for this service by the CCGs will be stipulated by the National Tariff. The National Tariff is published by NHS England and Monitor. Monitor is the sector regulator for health services in the UK.
From this system, NHS England has carved out a number of clinical areas for which it, rather than the CCGs, is responsible for commissioning directly on a national basis. These are: i) specialised services; ii) primary care; iii) offender healthcare; and iv) some services for the armed forces. Specialised services commissioning is particularly relevant for innovative treatments as it often includes high-cost treatments for such clinical areas as haematology and complex liver diseases. It also accounts for approximately 14% of the total English NHS budget.
NHS Commissioners' Duties
HASCA imposes a variety of statutory duties on CCGs and NHS England as commissioners. Some key examples of these are:
- to exercise their functions effectively, efficiently and economically;
- to act with a view to securing continuous improvement in the quality of services provided to individuals for the prevention, diagnosis or treatment of illness;
- to have regard to the need to reduce inequalities between patients of access to health services, and the outcomes achieved by those health services;
- to promote innovation in the provision of health services; and
- to promote research on matters relevant to the health service.
Any serious breach of these duties could help support a challenge of a decision by the NHS by way of English judicial review, and accordingly, it is worth bearing them in mind, and mentioning them in negotiations with the NHS.
Top Tips for Navigating the Commissioning Process
The new commissioning processes are governed by a veritable web of complex policy documents, and carried out by innumerable English NHS organisations and decision-making bodies. It can often be difficult to establish which body is responsible for a taking a decision, and on what basis such a decision will be made. However, any information you can gather about the way the system is supposed to work is valuable, because it could help you challenge unlawful decisions.
Below are our top tips for clients when navigating the English NHS commissioning processes:
- Seek a NICE technology appraisal: NICE technology appraisals are binding on the English NHS, meaning that it is legally obliged to fund treatments within 3 months of NICE recommending the treatment. Conversely, NHS commissioners must have regard to NICE guidance, but are not obliged to fund any treatment that NICE recommends. If your product can be made the subject of a NICE technology appraisal, this is a way of short cutting the English NHS commissioning process to guarantee that it is reimbursed.
- Engage with providers and CCGs as early as possible:HASCA has devolved certain key commissioning powers to local providers and CCGs. For several reasons it is useful to engage with these bodies as early as possible when bringing a drug or device to the UK market. First and most obviously, this will facilitate sales. Second, it can be used to generate clinical data from within the English NHS on how a treatment is used, which may be useful during the later commissioning process as evidence of a treatment's usefulness. Third, it raises awareness amongst healthcare practitioners and patients that a novel drug or device is on the market.
During the Commissioning Process
- Ensure that drugs and devices are clearly described: As explained above, there are several NHS funding routes depending on what clinical category a product falls into. However, these clinical categories are often not clearly defined, and funding routes may appear to overlap. To ensure that time and energy is not wasted pursuing a funding route that is ultimately not applicable to a product, it is vital that the clinical application of a treatment is described clearly. Further, once the English NHS initiates assessment of the treatment in question by a particular commissioning body (i.e. CCGs or NHS England) along a specific funding route, healthcare organisations are advised to take a critical view about whether that funding route is appropriate for that treatment, and whether it reflects the way the English NHS is supposed to work, according to its published documents and statutory duties.
- Take part in consultations: Monitor has a duty to consult with stakeholders on the proposals for the National Tariff. It is important that suppliers of drugs and devices engage with this consultation process to ensure that it is conducted fairly, and that Monitor reaches a reasonable outcome when setting national prices for the reimbursement of treatments. If you feel that a consultation is not being handled fairly, there are ways to challenge this according to English public law principles - contact us for more information.
- Request information on what kind of evidence is accepted:The English NHS does not publish clear standards of evidence it is prepared to take into account when making decisions on funding. In our experience, it may refuse to consider clinical studies that are not published or peer-reviewed. Such a refusal is not necessarily justifiable. Before supplying the NHS with evidence to inform its commissioning decisions, healthcare clients are advised to request a summary from the NHS of the nature of the evidence sought and an explanation of what value the NHS proposes to place on particular types of evidence.
- Focus the minds of decision-makers on their duties: As described above, HASCA introduced a raft of duties for NHS commissioners to observe. Public bodies are also subject to a variety of common law duties (such as the duty to act rationally) under English law. These are burdensome for commissioners, and it is not yet clear that the NHS has set up its decision-making processes to fulfil those duties. This means that those duties may not be at the forefront of commissioners' minds. During the commissioning process, if there appears to have been any inadequacy in any interim or final decisions made, it may be useful to draw decision-maker's duties to the commissioners' attention, possibly in a legal letter, to influence their approach to making the decision.
- Utilise Freedom of Information Act (FOIA) requests to obtain information on how decisions have been made: The NHS may not be forthcoming with providing information on how its decisions have been made. However, as a public authority, it is subject to the provisions of the English Freedom of Information Act 2000. FOIA requests may be deployed to access documents that detail how a decision has been reached, or bring to light the fact that such decisions have not been properly documented.
- Consider a variety of reimbursement structures: Because of its budgetary difficulties, the English NHS is keen to explore alternative commissioning mechanisms to ease the financial pressure it is under. This may be a fruitful way of ensuring patients have access to innovative treatments. These structures may take the form of risk-share agreements, fixed-fee arrangements, capitation contracts, and others.
- Communicate with providers and commissioners about what funding category your product falls into: If there is any ambiguity around the funding category of a product, it is sensible to supply providers and commissioners with material that clarifies this, so that there is no confusion around how your product is reimbursed when it is used by a healthcare provider. This is specifically encouraged by industry codes of business practice, such as the ABHI code.
At all stages of your dealings with the English NHS, remember that it is a public body, and it is susceptible to English law judicial review. The threat of seeking judicial review is often as powerful as bringing an actual claim, and you may be more likely to get the result you are looking for if you deploy legal arguments before a decision is made. Remember that the HASCA and English common law impose a variety of duties on English NHS decision-makers and if you think the NHS has breached one of these, it is sensible to get legal advice sooner rather than later.