Clinical Policies

The Clinical Policies on the website are updated on a monthly basis. The process of operationalizing these policies is via the use of BlueTeq in Secondary Care and e-RS in Primary Care, where appropriate.

Clinical Policies are approved and ratified by the Clinical Policy Advisory Group (CPAG).
Membership includes public health consultants, primary care clinicians, pharmacists, primary care commissioners and other stakeholders.

If you have any queries or concerns regarding the process or the information provided then please do not hesitate to contact the Prior Approval Team by emailing: ddicb.ebi.priorapproval@nhs.net. 

Not all treatments and medications are routinely funded on the NHS. This is because the effectiveness of certain procedures and medications can vary significantly amongst patients, so for some people treatments can be more harmful than they are helpful. The NHS has a responsibility to make sure it is using its limited resources in a way that gives patients the most health benefits and best outcomes. The ICB has a range of clinical policies which outline the treatments and procedures we fund and details of who may be eligible to receive them.

NICE Guidance:

The role of the National Institute for Health and Care Excellence (NICE) is to improve outcomes for people using the NHS and other Public Health and Social Care services, by producing several different types of guidance documents.

• Some of the NICE recommendations are made with more certainty than others. Where there is clear and strong evidence of benefit, NICE will use the word 'offer'. Where the benefit is less certain NICE will use the word 'consider'.
• The ICB is allowed to take decisions which do not follow guidance (other than Technology Appraisal Guidance) if they have a good reason to do so and have considered the consequences of the decision e.g. quality of the evidence, availability of resources and competing priorities. All are valid reasons for not following published NICE guidance.
• For more information about NICE guidance, please click on the following link: Developing NICE guidelines: the manual
  
  

NHS Derby and Derbyshire Integrated Care Board policy on ‘Procedures of Limited Clinical Value’ (PLCV)

Research evidence shows that some interventions are not clinically effective or only effective when they are performed in specific circumstances. The purpose of the Procedures of Limited Clinical Value (PLCV) policy is to clarify the commissioning intentions of Integrated Care Board (ICB). The ICB will only fund treatment for clinically effective interventions that are then delivered to the right patients.

This policy lists a number of procedures and services that the ICB restrict funding for out of a fixed budget. Patients should only be referred for the procedures and services listed in this policy if they meet the eligibility set out.  If a patient has not had a full diagnosis (relating to PLCV policy areas only), the referring GP is able to refer for an opinion by using the PLCV Opinion Proforma.

The DDICB agree with the Local Medical Committee's (LMC) following stance on PLCV:  ‘GPs are not specialists, we therefore reserve the right to refer by letter to secondary care for an opinion; the specialist having reviewed the patient can decide whether a procedure is necessary and PLCV criteria would apply at this point. A referral for an opinion should not go via prior approval as the request is for an opinion not a procedure’.  For further information please click on the following links: https://www.derbyshirelmc.org.uk/position, Derby and Derbyshire ICB PLCV position letter.

Any issues related to this matter should be raised directly with the provider.  However, failing this please contact ddccg.medicinesmanagement@nhs.net

Contractual Agreements

A Contract Variation (CV) will be issued to providers as and when a policy is agreed in accordance with the NHS Standard Contract general terms.

Document Status

These are controlled documents, whilst these documents may be printed; the electronic versions posted on the ICB’s website is the controlled copy.  Any printed copies of these documents are not controlled.  As controlled documents, these policies should not be saved onto local network drives but should always be accessed from the Intranet.

If you need help accessing a document it is available on request in other formats (for example large print, easy read, Braille or audio versions) and languages.  Please call the Communications & Engagement Team on 01332 868730 or email DDICB.Communications@nhs.net

Equality Statement

Derby and Derbyshire Integrated Care Board’s aim is to design and implement policy documents that meet the diverse needs of the populations to be served. The NHS workforce has a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012.

Derby and Derbyshire ICB is committed to ensuring equality of access and non-discrimination, irrespective of age, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex (gender) or sexual orientation.

It takes into account current UK legislative requirements, including the Equality Act 2010 and the Human Rights Act 1998, and promotes equality of opportunity for all and ensures that no-one receives less favourable treatment owing to their personal circumstances.

Due Regard

In carrying out their functions, the Clinical Policies Advisory Group on behalf of Derby and Derbyshire ICB are committed to having due regard to the Public Sector Equality Duty.  This applies to all the activities for which the ICB is responsible, including policy development and review. 

Patient and Public Involvement

The ICB has released guidance to ensure that commissioners and NHS Trusts working within Derby and Derbyshire ICB meet legal obligations to inform, involve or consult with patients and members of the public in any change that takes place to frontline service provision. The guidance can be found here.

Derbyshire Health Optimisation for Surgical Interventions

Any surgical intervention carries a risk, however small, to the patient. These risks are increased in those who are overweight/ obese, smoke or have poorly controlled long term conditions. When surgery is planned this is a good opportunity to offer support to patients to stop smoking, reduce their weight and optimise treatment of long term conditions in order to reduce their risks and improve their recovery and other outcomes. This could be achieved by referral to an appropriate lifestyle service for help with obesity and smoking and working with healthcare professionals for management of any long term conditions.

Purpose of the Policy

The purpose of the Procedures of Limited Clinical Value (PLCV) policy is to clarify the commissioning intentions NHS Derby and Derbyshire ICB.

The ICB commissioners only fund treatment for clinically effective interventions that are then delivered to the right patients. It sets out the treatments deemed to be of insufficient priority to justify funding from the available fixed budget.

This policy list a number of procedures and services that the ICB restrict funding for. Patients should only be referred for the procedures and services listed in this policy if they meet the eligibility set out. The onus is on the clinician to seek prior approval from the commissioner by completing a prior approval application. The clinician must provide sufficient information to evidence how the patient meets the criteria.

If a provider undertakes one of the procedures contained within this policy commissioners will not reimburse the provider unless explicit agreement has been given by the ICB, via the Prior Approvals procedure.

Please note; this document does not reference those interventions where the ICB has previously published policy statements setting out restrictions/criteria/prior approval requirements.

Medical Emergencies and Red Flags 

Medical emergencies and 'red flags' are excluded from NHS DDICB clinical policies and position statements.

NHS Funds

This policy supports the decision making process associated with the allocation of resources for commissioning. It will be used to support the development of effective, efficient and ethical NHS Standard Contracts with provider organisations, and the procurement of intentions on an exceptional basis.

The policy establishes the framework within which the ICB can demonstrate that their decision making processes are fair, equitable, ethical and legally sound.

Assessing what the overall population most needs

Our approach to this situation is to prioritise what we spend, so that the local population gets access to the healthcare that is most needed.
This assessment of need is made across the whole population and, wherever possible, on the basis of best evidence about what works. We also aim to do this in a way that is fair, so that different people with equal need have equal opportunity to access services. This approach is not new. It is consistent with other NHS organisations who commission healthcare for their local populations.
One result of this kind of assessment is a list of some of the treatments which can only be paid for by the local NHS in certain restricted circumstances, and also a number of treatments which do not work well enough to justify any use within the local NHS. The Derbyshire policy group aim is to continually to review the list of procedures to ensure the policy reflects the best available evidence and allocation of our resource is fair.

Procedures of Limited Clinical Value and associated treatments are not commissioned by the NHS Commissioners, except where an individual patient satisfies the threshold statement or criteria against a procedure or treatment. Clinicians considering offering a patient a restricted procedure or treatment should satisfy themselves that the threshold statement or criteria against the procedure or treatment are satisfied. Where a patient satisfies the threshold statement or criteria, the procedure or treatment is allocated a prior approval reference, and can be undertaken. Where the threshold statement or criteria are not met, then the procedure or treatment is excluded for that patient.

Definitions

Procedures of Limited Clinical Value (PLCV) are those which deliver a relatively poor output/outcome to the population. In this policy, the term PLCV has been extended to include procedures which have been identified as being either only marginally effective or ineffective in terms of their clinical impact. There may additional significant differences in value depending on the setting in which the procedure is delivered (usually due to large differences in pricing between providers).

The procedures (PLCV) in this policy are those which:

• Have clear evidence that they are ineffective. 
• Have no evidence of the effectiveness and are not being delivered in a context that would allow the gathering of evidence base to judge effectiveness, i.e. through ethically approved research. 
• Have evidence of effectiveness but are being offered to patients whose characteristics are different from the characteristics of the patients in the research studies which produced the evidence for effectiveness. 
• Use resources that would produce more value, namely a better balance of benefit, if invested in some other service for the same group of patients for example, the procedure is of better value when delivered in a specific setting.
• Low level of evidence with associated high cost verses current standard practice.
• Definition of a child: Unless otherwise defined within the policy a child is defined as an individual who has not yet reached their 18th birthday. Within this document the terms "procedures of limited clinical value” and "low priority procedure(s)” are used synonymously.

Commissioning Requirements

A number of national and local organisations, such as National Institute for Health and Clinical Excellence (NICE), have developed evidence based advice to inform commissioning decisions on low priority treatments. These treatments or procedures are not usually funded by the NHS. In addition the ICB has responsibility to decide the priorities for commissioning in line with agreed criteria.

Making Commissioning Decisions

Commissioning involves specifying, securing and monitoring services that are evidence- based, cost effective, of high quality and meet individuals ?needs” and provide "value for money in the use of public resources”. 

Determining the Evidence Base

Evidence for treatment effectiveness and efficacy is available from many sources, including NICE, Cochrane Institute, Royal Colleges, Professional guidelines, and sources such as peer reviewed journals or technical notes. Evidence varies in its robustness, ranging from meta-analyses of randomised control trials with large populations of participants, to traditional consensus about best practice. The ICB has considered the source, extent and quality of the evidence in reaching their decisions.

Managing Exceptions

In their dealings with patients and the public providers should, if necessary, make it clear that the decision by NHS Commissioners to consider treatments or procedures to be of low priority under this policy is a considered decision made against their responsibility to seek the greatest health advantage possible for local populations using the resources allocated to them and that it is necessary for the NHS Commissioners to make decisions regarding the investment of resources in interventions which achieve the greatest health gain for the local population.

Where individual patient circumstances require the escalation of their care providers should refer to the Policy and Procedure for the Authorisation and Management of Individual Funding Requests,

Ethical and Legal Policy for Decision Making

The ICB has a Decision-Making Framework which is kept under review by the ICB's Governing Body. The policy can be found here.

Implementation 

The Commissioning Policy for PLCV is set out below and can be incorporated into contractual and service level agreements. NHS Derby and Derbyshire ICB will require primary and secondary care service providers to embrace and abide by the policy and advise patients accordingly.

The policy is implemented by the Primary Care and Secondary Care Health Professionals when advising and referring patients and by providers when considering the treatment options for patients. Those making referrals should not refer to any provider for a treatment or procedure covered by this Policy. Providers should not suggest, recommend or otherwise offer excluded treatments or procedures covered by this Policy to any patient. Providers should only suggest, recommend or otherwise offer restricted treatments or procedures covered by this Policy to patients who satisfy the appropriate threshold statement for that treatment or procedure.

The Schedule of PLCV

The schedule is informed by indicative codes. There may be cases where a code is not included but the procedure is called the same; it should be assumed that the threshold will apply in the same way. 

This policy should be read in conjunction with other policies and pathways e.g. East Midlands Commissioning Policy for Cosmetic Procedures 2014, musculoskeletal pathway.

Distribution 

All providers and referrers, secondary care services, primary care services, community care services, associate commissioners.

Monitoring the Policy 

NHS Commissioners will monitor the adherence to this policy through the contractual process, using contractual levers where breaches of the Policy are identified.

• Referrals to secondary care that are outside of this Policy will be routinely monitored by the Commissioning Management and the Contracts Management Teams of the NHS Commissioners.
• Any procedures marked as ‘Requires Prior Approval’ must be approved by the ICB before the surgery is undertaken using the agreed form. Commissioners will not pay for any procedures undertaken without the required approval from the responsible commissioner 
• NHS Commissioners will provide periodic reports to their reporting committees reporting the number and nature of breaches of the Policy, by provider and by procedure. 
• Where there are defined thresholds, the compliance with the criteria will be subject to regular clinical audits carried out or organised by NHS Commissioners. The audit process will require providers to produce patient specific evidence that confirms the threshold criteria for procedures were satisfied at the time the decision to offer the procedure to the patient was taken. Where audit shows that the evidence is not available or is deficient or fails to satisfy the auditor that the threshold criteria were met at the time the decision to perform the procedure was taken, then the default will be to consider the procedure was excluded and therefore it will not attract payment from the NHS Commissioners. 
• NHS Commissioners reserve the right to reduce the value of all payments for procedures with OPCS codes that match those for PLCV

Maintaining an up-to-date Policy

NHS Derby and Derbyshire ICB will abide by this policy when making decisions relating to the provision of low priority treatments.

Specifically, the role of the ICB is to:

• monitor the implementation of the policy and the impact it has on clinical decision making;
• inform referrers including all Primary Care Practitioners, medical or non-medical;
• inform all service providers, with whom the ICB has formal contractual arrangements, of the policy;
• review the policy and the accompanying schedule on a 2 yearly basis or where an urgent consideration of new evidence is justified.