The Development and Review of Clinical Policies for Lancashire and South Cumbria Clinical Commissioning Groups (CCGs) – Frequently Asked Questions (FAQs)
Supplementary FAQ’s
These frequently asked questions are supplementary to the FAQ’s already identified as part of the clinical policy development and review process.
Why are we only being allowed to feedback on the criteria of some of these policies and not all five?
NHS England has 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 set of procedures identified by NHS England following their original EBIs notified to CCGs in 2018/19. This new set is referred to as EBI2.
EBI2 procedures impact on two of the clinical policies going out to public engagement, one in full (the Chronic Rhinosinusitis Surgery policy is based entirely on the EBI2 guidance) and one in part only (the Hernia surgery policy – most of this policy is beyond the scope of the EBI2 mandated procedure, which is only about inguinal hernias with minor or no symptoms).
We are requesting feedback and comment in full, including the access criteria, on four of the five policies discussed below. NHS England has already undertaken a patient and public consultation on the criteria identified in the fifth policy (Chronic Rhinosinusitis) and there is very little scope to change this further. Although NHS England is making the criteria for this treatment 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.
What will this mean to patients?
The proposed draft policies will 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.
Two of the policies (the provision of CGMs for diabetes and the provision of wigs) expand the access criteria, allowing more people to benefit from these treatments and services. Two of the policies are new to most residents in Lancashire and South Cumbria and identify access criteria for the first time. This may mean some patients are no longer eligible for these procedures, as the non-surgical alternatives are safer, effective means of treating these conditions for these patients. For the remaining policy (facial nerve rehabilitation) it is now proposed that this is no longer routinely commissioned for those who met the restricted access criteria, and these have been removed.
Where a procedure is no longer routinely available on the NHS or has restrictive access criteria, patients can still have access to them if their GP/consultant believes they are an exception and will benefit from receiving it, given their individual clinical circumstances. This is called submitting an Individual Funding Request (IFR) and this option is always open to doctors and others.
An individual funding request must be submitted by your clinician (GP or other health professional). Submitting an IFR does not mean the treatment will be provided, as each case must be proven on its own merits.
Policy for the provision of continuous glucose monitoring and flash glucose monitoring for patients with Diabetes Mellitus:
What are glucose monitoring devices?
The aim of diabetic control is to avoid both short and long-term complications by achieving a blood glucose level as close as possible to normal. In some patients with diabetes, good blood glucose control is difficult to achieve through injections and self-monitoring. Technologies including insulin pumps, continuous glucose monitoring devices and flash glucose monitoring may be considered as part of a managed plan for diabetic patients.
A Continuous Glucose Monitor (CGM) is a small device that is inserted under the skin. It measures glucose levels continuously throughout the day and night and can show trends in glucose levels over time. The information is available instantly when a patient looks at their receiver. Importantly, it can alert the user if the glucose goes too high or too low.
A flash glucose monitor uses a sensor that is attached to the back of the patient’s upper arm. It measures glucose levels throughout the day and stores this information at 8-hour intervals. Glucose levels can be seen at any time by scanning a reader or smartphone over the sensor. Some flash systems have optional alarms to alert the user if their blood glucose goes too high or too low.
Some changes to the policy have already taken place – why?
The use of continuous glucose monitors (CGMs) was expanded last year, and by March 2021, all joint maternity and diabetes services were required to identify and offer all women with Type 1 diabetes a CGM as part of their care plan. This was in line with NICE guidance. Due to the pressures caused by the COVID-19 pandemic, there was neither the resources, the opportunity nor the timescale to permit a meaningful engagement exercise on these changes. It would have been at the height of the pandemic last winter.
To meet the Government deadline of March 2021, and as this was also a positive development, expanding the type of patients who could receive CGMs, this policy was amended to allow pregnant women with Type 1 diabetes to benefit from greater access to CGMs from that date.
What changes have already been made?
The main change was to offer CGM to all pregnant patients with Type 1 diabetes; previously this had not been the case and was in line with development in NICE guidance.
Type 1 diabetes increases the risk of undesirable outcomes in pregnancy. Research shows that use of continuous glucose monitoring throughout pregnancy improves glucose control and reduces the risk of harm to mother and baby. Information collected by the CGM is also shared with a patient’s maternity and diabetes care team so that they can review and adjust care appropriately.
In addition, the policy was also amended to make it possible that Flash monitors could be used as an alternative to CGMs where a pregnant Type 1 diabetic patient was unable to use a CGM or where they expressed a clear preference to have a Flash monitor rather than a CGM.
What further changes are being proposed?
NHS England guidance now recommends making both CGMs and Flash monitors available to Type 2 diabetics who take insulin (basal-bolus insulin regimen), when these patients fulfil specified criteria.
In addition, the use of Flash monitors instead of CGMs is also supported where a doctor/consultant of a diabetic patient feels this will benefit the patient, given their circumstances.
Will continuous glucose monitoring flash glucose monitoring devices be available to anyone with diabetes?
No, the new policy identifies that these devices are available for patients who meet specific requirements and have Type 1 diabetes, Type 2 diabetes who use basal-bolus insulin regimen. It also includes patients with or non-type 1 or non-type 2 diabetes caused by a near absence of insulin production who meet the criteria. Patients with Type 2 diabetes who do not use insulin will not be eligible for these devices.
The purpose of these devices is to improve the control of diabetes in patients, but many patients can satisfactorily control their diabetes using alternative means, without the need for these devices. Where this is the case funding would not normally be allowed.
Provision of Wigs section of the Policy for the Commissioning of Cosmetics Procedures:
Why are we only seeing the provision of wigs section and not the whole cosmetics procedures policy?
Most clinical commissioning policies have a three-year review cycle; their review date is set three years after the policy is ratified/adopted by the CCGs. A review may be needed before this review date if the guidance from NICE or other professional or legislative bodies means the policy is no longer appropriate or information comes to light that impacts upon the implementation and operation of the policy.
The Policy for the Commissioning of Cosmetics Procedures is not due to be reviewed until September this year (although this may be done later due to the delays in the review programme caused by COVID-19). However, some inconsistencies of interpretation and implementation had come to light concerning the section dealing with the provision of wigs. In addition, there were some concerns that the existing wig section of the policy, as written, may not fully address some real or perceived health inequalities and did not fully account for inconsistencies in service provision that had also emerged since the existing policy was ratified.
It is appropriate, therefore, to review the provision of wigs section of the cosmetics procedures policy now, ahead of the review of the full cosmetics policy.
What are the proposed changes to the provision of wigs section?
To address the inconsistencies and to ensure the policy met the Public Sector Duty, the provision of wigs section of the cosmetics procedures policy has been reviewed and updated and a further equality impact assessment undertaken on this element of the policy.
Previously, the provision of wigs was restricted to the correction of hair loss as part of cancer or trauma treatment pathways. It is proposed to expand this service to those patients where hair loss is a symptom of a health condition. No health conditions are specifically mentioned (such as alopecia) as hair loss for all health conditions is included.
The provision of wigs remains restricted as it is not available for the correction of hair loss due to ageing or male pattern baldness, and there remain limits to the number/frequency of provision, which are unchanged from the previous wording of the policy.
Facial Nerve Physiotherapy and Electrotherapy Policy:
Why is the facial nerve policy being reviewed?
This is an existing policy that reached its standard review date last year but was delayed due to COVID-19. The existing policy is called the Policy for Rehabilitation after Damage to the Facial Nerve.
What is facial nerve physiotherapy?
Damage to the facial nerve has several causes but the damage, in most cases, is expressed by some degree of weakness or paralysis in the facial muscles (often referred to medically, as facial palsy). Bell’s palsy is one of the main causes of acute facial nerve palsy (75% of all cases) but is not fully understood. In most cases symptoms disappear over time and full muscle function returns, but in a few cases the damage is permanent. Other causes of facial nerve palsy include injuries during surgical procedures and tumours.
Physiotherapy of the facial nerve consists of physical therapy using tailored facial exercises. The existing policy permitted the commissioning of specialised physical therapy rehabilitation for facial damage in limited circumstances.
What treatment does the reviewed policy allow?
The latest clinical evidence to support the use of tailored facial exercises is quite weak and does not indicate that this treatment is effective in treating facial nerve palsy. The number of cases each year is very small, with only 22 cases across Lancashire and South Cumbria in the last five years, most of which did not satisfy the existing policy criteria.
Given the small number of cases and the lack of effectiveness, the revised policy no longer supports the rehabilitation of damage to the facial nerve. The updated draft policy now indicates this procedure will not be routinely commissioned, and this has been expanded to cover electrotherapy for facial nerve paralysis, which is also ineffective. The policy has been renamed to reflect its broader scope.
Hernia (abdominal) surgery Policy:
What is an abdominal hernia?
A hernia occurs when an internal part of the body pushes through a weakness
in the muscle or surrounding tissue wall. A hernia usually develops between the chest and hips (the abdominal area of the body). In many cases, it causes no or very few symptoms, although there may be a swelling or lump in the abdomen or groin.
There are various types of abdominal hernia (hernias that occur elsewhere in the body are not covered by the policy), and these include inguinal, umbilical, femoral and incisional.
Inguinal hernias occur when fatty tissue or a part of the bowel pushes through into the groin at the top of the inner thigh or lower abdomen. This is the most common type of hernia and it mainly affects men. It is often associated with ageing and repeated strain on the abdomen. Minimal symptomatic inguinal hernia, which is one of the interventions in NHS England’s EBI2 guidance (and the only EBI2 procedure that impacts on this policy), is one of these types of hernia.
Femoral hernias also occur when fatty tissue or a part of the bowel pushes through into the groin at the top of the inner thigh. They're much less common than inguinal hernias and tend to affect more women than men.
Like inguinal hernias, femoral hernias are also associated with ageing and repeated strain on the abdomen. As this type of hernia is more likely to become strangulated (cut off the blood supply) they should always be referred for treatment.
Umbilical hernias occur when fatty tissue or a part of your bowel pushes through the abdominal wall near the navel. This type of hernia can occur in babies if the opening in the abdomen through which the umbilical cord passes doesn't seal properly after birth. Adults can also be affected, possibly as a result of repeated strain on the abdomen.
An incisional hernia is one that occurs at the site of a healing or healed surgical scar. They are quite common (between 15-20% of abdominal hernias) and many may not need to be treated or can be left untreated for some time. They will often fall under the ‘watchful wait’ approach, with referrals for surgery only when needed.
What treatment does the policy allow?
While many hernias have no symptoms, although a swelling or lump may be visible, hernias can get worse over time and there are cases when a watch and wait process is put in place, either for the type of hernia or for hernias that do not currently require attention. Hernias can become obstructive (causing a blockage) or strangulated (cut off the blood supply), and as these conditions are life threatening, they are treated as an emergency.
The policy identifies how the various types of hernia will be managed and the access criteria for when surgery, whether planned or emergency, is recommended or necessary. Femoral hernias and groin hernias in females present greater risks and the policy indicates these hernias should always be referred for surgical assessment without delay. Where hernias have no symptoms or the symptoms are minimal (and cause little or no pain, disability or physical discomfort) and do not prevent normal activities, the policy indicates surgical management of these hernias is not supported.
The hernia surgery policy applies to adults aged 19 and over.
How come this policy already exists in Preston and Chorley and South Ribble CCG areas?
A policy harmonisation process is in place across Lancashire and South Cumbria CCGs as some policies that have been developed by individual CCGs are not used in all 8 CCGs. The process of harmonisation continues as we move towards a single NHS body across the region.
All the various types of abdominal hernia mentioned above are included in the existing hernia surgery policy adopted by the two central Lancashire Clinical Commissioning Groups (Preston and Chorley/South Ribble). The new draft policy is similar in scope but with greater definition and is more up to date. If adopted, the new draft policy will, therefore, apply to all 8 CCGs going forward. The public engagement requires feedback on the full policy from all CCG areas.
Chronic Rhinosinusitis Surgery Policy:
What is chronic rhinosinusitis?
The sinuses are mucus secreting, air filled cavities in the face and head that drain into the nose. Environmental, infectious (colds/flu) or inflammatory conditions can damage the lining of the sinuses, causing them to swell. Acute sinusitis lasts for 2-3 weeks and may recur, causing repeated episodes of acute sinusitis that can lead to chronic rhinosinusitis. Chronic, in medical terms, means something that continues for a long time or is constantly recurring; rhino refers to the nose.
Chronic rhinosinusitis (CRS) is a condition where the nasal sinuses become continually inflamed for a period of 12 weeks or more. In a small number of cases the damage may remain even after the infection has gone, and, if other treatments do not work, may require surgery.
What treatment does the policy allow?
The purpose of surgical treatment for chronic rhinosinusitis is normally to relieve the symptoms caused by the condition, which can include nasal blockage, discharge, alteration to smell, and facial pressure or pain.
Surgery for chronic rhinosinusitis is covered by NHS England’s EBI 2 guidance, which is mandated, and outlines the various criteria to be met for surgery to take place. As it is mandated, the public engagement on this policy is to inform and gather feedback on any issues or concerns relating to its implementation.
What if my GP/consultant feels one of these procedures is still my best option, even when it is not supported by the access criteria for these policies?
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 or the treatment is normally available then, as with other clinical policies, your clinician can put in an Individual Funding Request, which are decided on a case-by-case basis.
When will these policies be adopted by the CCGs?
Public engagement will take place over an 8-week period ending on Friday ________, following which the responses provided will be assessed. Assessment of the feedback for these policies is reported to the Commissioning Policy Development and Implementation Working Group, which oversees the policy development and review process, and may then lead to changes in the policies going forward. However, as the chronic rhinosinusitis policy is mandatory, no change will be made to the policy criteria for this policy, but consideration will be given to any concerns regarding its implementation.
Once the Commissioning Policy Development and Implementation Working Group has considered what, if any, changes to the policies are required, the policies are then given final consideration by the Strategic Commissioning Committee, which ratifies polices on behalf of all 8 CCGs in Lancashire and South Cumbria.
What are clinical commissioning policies?
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 changes to the treatment/procedure concerned, the impact of clinical research and development and the pressures upon the health economy.
Why do we have clinical policies?
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.
What are the aims of clinical policies?
- 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.
What is the governance framework for developing clinical commissioning policies?
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.