The Review of Clinical Policies for Lancashire and South Cumbria Clinical Commissioning Groups (CCGs) – Frequently Asked Questions (FAQs)

NHS England has recently issued statutory guidance to NHS Clinical Commissioning Groups (CCGs) on a range of medical and surgical treatments and procedures and expects these to be introduced by local CCGs and NHS Trusts over the coming months.  These procedures NHS England calls Evidence Based Interventions (EBIs) and this is the second batch of procedures identified by NHS England following their original EBIs notified to CCGs in 2018/19.

NHS England has already undertaken a patient and public consultation on the criteria identified in these policies and there is very little scope to change them further.  Although NHS England is making the criteria for these treatments’ mandatory (as a minimum – CCGs can elect to go further), Clinical Commissioning Groups are still required to inform and involve patients and members of the public. A suitable period of public engagement needs to be undertaken, therefore, but it must allow CCGs to meet the obligations laid down by NHS England.

One of the policies, Sacral Neuromodulation, is not included by NHS England in EBI 2 and is a new local policy for Lancashire and South Cumbria. Very few patients experience this treatment and all must travel out of the area to receive it, but as it is a local policy, feedback on the full policy, including its criteria, is welcomed.

Public engagement will take place for these policies over a 4-week period, to be completed by Friday 19 November.

Both NHS England and the NHS Clinical Commissioning Groups are of the view that one of the main objectives of policies of this nature is to reduce avoidable harm to patients. With surgical procedures, there is always a risk of complications. In addition, professional staff time is wasted if unnecessary procedures are undertaken.

The staff time and resources saved by undertaking this procedure appropriately allows that time and resources to be used elsewhere within the local NHS.  Any savings generated in this respect, therefore, are ploughed back into the service where it is needed.  Inappropriate care is also poor value for money for the taxpayers who make the NHS possible.

Having consistent treatment decisions based on the latest evidence also helps health professionals keep up to date without removing their clinical discretion, which forms part of their professional duties.  At a time when demand far outweighs capacity, these decisions reflect the national and local priority of using resources effectively.

The policies being introduced guide the decisions made by CCGs about the procedures that will be made available to patients for these conditions.  This is in both what the CCG will commission and in what Providers of services will be asked and paid to deliver.  This has a direct impact upon which of these procedures patients and the public can expect to receive from their local NHS services.    Although some patients may no longer be eligible for these procedures, this is because the non-surgical alternatives are safer, effective means of treating these conditions.

The key purpose of the Evidence Based Intervention programme is to improve patient care.  All policies have been reviewed by national organisations, Royal Colleges of the relevant medical specialty and are advisory for busy clinicians who do not always have the time to spend reading the latest research, so they are a way of disseminating safe and effective care.

Where a procedure is no longer routinely available on the NHS (although this is not the case for any of these policies), patients can still have access to them if their GP/consultant believes they are an exception and will benefit from receiving it.  This is called submitting an Individual Funding Request (IFR) and this option is always open to clinicians.

An individual funding request can be made by your clinician (GP or other health professional) if they believe that a particular treatment or service that is not routinely offered by the NHS is the best treatment for you, given your individual clinical circumstances. 

This is one of the Evidence Based Treatments mandated by NHS England. Cystoscopy is a diagnostic procedure used to examine the lining of the bladder and urethra. The procedure requires the use of a rigid or flexible endoscope, which can be done under general (if the rigid scope is used) or local anaesthesia, if the flexible endoscope is used. An endoscope is a long, thin tube that has a light and camera at one end. Images of the inside of your body are shown on a television screen, allowing the specialist to investigate and diagnose the underlying cause of symptoms.  Cystoscopy of the urinary tract usually causes the patient discomfort and may cause some patients pain or bleeding.

The new EBI based policy identifies the criteria that must be met for this procedure to be funded on the NHS. This indicates that cystoscopy should only be used after non-invasive (which means tests or treatments do not require breaking the skin or entering the body) techniques of assessment have been considered and the patient has one of more specific issues caused by the problem (the policy lists five of these, including recurring infection and pain). It is also possible that a cystoscopy of the lower urinary tract may be required where more invasive surgery is being considered.

The policy supports the use of this procedure when these conditions are met.

Prostatic hyperplasia is the medical term for an enlarged prostate, which can affect more than 50% of men as they grow older, and which impacts on their capability to urinate. For some men this develops into a condition that needs treatment. In these cases, surgical treatment should be a last resort. Benign means that it is not cancerous. The majority of cases of an enlarged prostate are not cancerous and there is no specific link between having an enlarged prostate and cancer of the prostate.

The new EBI based policy identifies the criteria that should be met before surgical treatment is undertaken. It requires that surgeons have a discussion about the risk and benefits of the procedure in terms of future continence and sexual functions with the patient.  Although the policy permits surgery it is only when symptoms are severe or complicated and drug treatments and other options have been unsuccessful that surgery should take place.

Surgery usually means removing some tissue from the prostate to reduce its size, using cystoscopy. The most common form of surgery is known as Transurethral resection of prostate (TURP), but other surgical techniques can also be used.

A joint cavity is the space between bones lined by synovial membranes (which create fluid to lubricate the joint) and articular cartilage (a white elastic tissue that allows bones to glide smoothly against each other). The knee joint cavity supports the lubrication and fluidity of three bones, the femur, tibia and patella (kneecap).

This policy relates to elective endoscopic knee procedures on the knee joint cavity, often referred to as knee arthroscopy.  Endoscopic procedures on the knee joint cavity are surgical techniques used with the intended outcome of diagnosing or treating conditions affecting the knee joint, including damaged ligaments or cartilage and loose bodies within the knee joint. Elective means that the procedure is planned surgery, arranged by appointment at a hospital.

This is an existing policy that has been updated to bring it into line with the EBI guidance. This has required a few minor amendments to the circumstances in which endoscopic procedures will be undertaken, but most elements remain unchanged. One element which was considered ineffective has been removed.

Overall, the policy continues to support the commissioning of these procedures, but the clinical aspects of the process have been updated to reflect the latest medical evidence and best practice in line with the EBI directive.

Sacral neuromodulation is a two-stage surgical procedure used to treat men and women with chronic urinary retention and several other conditions relating to function and symptoms in the pelvic area. The procedure implants a medical device which can help improve bladder functions by sending electrical impulses. Conditions treated by sacral neuromodulation include incontinence (both urinary and faecal), constipation and pelvic pain due to endometriosis and other conditions.

The treatment of some of these conditions with sacral neuromodulation is commissioned separately by NHS England and these are therefore, beyond the scope of this policy.

This new draft policy, which is not one of the EBI directives from NHS England, identifies the criteria people must meet to qualify for this procedure. Some conditions relating to the function and symptoms of the pelvic area are not effectively treated by sacral neuromodulation. This policy identifies that it will be commissioned in limited circumstances, which is for the treatment of chronic non-obstructive urinary retention (when someone is unable to empty the bladder, either completely or at all). This is not a common condition, with only a small number of patients needing this treatment each year across Lancashire and South Cumbria.

The Clinical Commissioning Groups (CCGs) for Lancashire and South Cumbria propose to commission sacral neuromodulation for this purpose only and that a permanent implant should only be undertaken after a successful trial has taken place and that this should be done by a specialist team.

The CCGs will not routinely commission the use of sacral neuromodulation for constipation, or any other pelvic condition, as there is weak evidence to support its use. They consider the use of this procedure for these conditions is not in line with the Principles of Effectiveness and Cost-Effectiveness.

As this is not an EBI related policy, feedback about the policy criteria is welcomed.

The focus of these policies is to reduce the use of ineffective treatments on patients, which in turn releases staff time (urologists and other specialists and nursing staff) and resources (theatre capacity, beds etc.) to concentrate on those procedures that are effective and create better outcomes for patients. This will also support the capacity to identify cancers and other treatable conditions which currently have long waiting lists.

All the procedures identified in these policies will continue to be available to patients, but a few will see a lower level of activity (the first two ‘urology’ related policies) when more appropriate, less invasive treatments are encouraged.

The policies indicate the criteria that must be satisfied for these treatments to be offered to patients.  If your GP or consultant is of the opinion that your case in an exception and that you should receive one of these treatments even though it does not satisfy the criteria then, as with other clinical policies, your clinician can put in an Individual Funding Request, which are decided on a case-by-case basis.

Public engagement will take place over a 4-week period ending on Friday 19 November, following which the responses provided will be assessed.  However, as three of these policies are mandatory, no change will be made to the policy criteria for these three policies, but consideration will be given to any concerns regarding their implementation.

Assessment of the feedback for the fourth policy, Sacral Neuromodulation, may lead to changes in the policy. All four policies will then need to be considered by the Commissioning Policy Development and Implementation Working Group, which is overseeing the policy development and review process, before final consideration by the Strategic Commissioning Committee, which ratifies polices on behalf of all 8 CCGs in Lancashire and South Cumbria.

Every NHS Clinical Commissioning Group (CCG) is responsible for determining the range and level of clinical/medical services provided to the public it serves. In doing so CCGs are legally obliged to develop and publish any policies it has adopted to determine the availability of specific treatments or procedures for the local population.

A clinical commissioning policy is a document that describes in an open and transparent manner in what circumstances a CCG or group of CCGs will commission (give authority to undertake, pay for and monitor) specific healthcare services, treatments or procedures.

Clinical commissioning policies are evidence-based but must also reflect other important considerations such as cost and affordability. They are subject to regular reviews, usually every three years, but this may be more frequent depending upon the treatment/procedure concerned, the impact of clinical research and development and the pressures upon the health economy.

A CCG must make sure it is using its limited resources to maximum benefit for each patient treated and for the population it serves. It must also ensure it is commissioning the most effective and appropriate healthcare treatments and procedures. This means making decisions about priorities and about which treatments and procedures will and will not be provided under the NHS in their area.

Clinical policies are intended to provide a resource that can be used to ensure a consistent understanding of the specific clinical circumstances that must be met for a treatment or procedure to be commissioned by a CCG. Policies can be used for this purpose by stakeholders across the system including clinicians, commissioners, appeals panels and patients.

The main objective for having a commissioning policy is to ensure that:
• Patients receive appropriate, evidence-based health treatments in the right place, at the right time.
• Treatments that are routinely undertaken represent the most effective and cost- effective use of the limited resource available.
• Treatments with no or a very limited clinical evidence base are not routinely undertaken.
• Treatments with minimal health gain are restricted.
• The risk of avoidable harm is reduced. With all surgical treatments and procedures, there is always a risk of complications and adverse effects which could be avoided.
• Clinicians are assisted in maintaining their professional practice in line with the changing evidence base.
• Available resources are maximized, and waste is avoided as ineffective care is poor value for money for the taxpayer and the NHS.

Clinical policies are developed and ratified within and form part of a robust governance framework. In developing this framework CCGs have had regard to relevant law and guidance, including their duties under the National Health Service Act 2006, the Health and Social Care Act 2012 and the National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012; the Joint Strategic Needs Assessment; and relevant guidance issued by NHS England.

CCGs must also have due regard to the guidance issued by NICE (National Institute of Health and Care Excellence), some of which is statutory. Even where NICE guidance is not statutory, CCGs must be able to justify deviations from the guidance provided.

All clinical commissioning policies are built upon and supported by a statement of principles. The principles are appropriateness; effectiveness; cost-effectiveness; ethics and affordability, which all clinical policies must meet. Together with a policy regarding clinical exceptionality and the general policy for decision-making, these documents form a suite of policies that create a governance framework for the formulation and ratification of clinical policies.

The governance framework is supported by all eight CCGs in Lancashire and South Cumbria and provides a consistent, equitable and sustainable system for decision-making that meets the demands placed upon CCGs by statute and the NHS Constitution.