Greater Manchester EUR Policy Statement on: Tattoo Removal GM Ref: GM067 Version: 2.2 (28 January 2019)

Transcription

1 Greater Manchester EUR Policy Statement on: Tattoo Removal GM Ref: GM067 Version: 2.2 (28 January 2019)

2 Commissioning Statement Tattoo Removal Policy Exclusions (Alternative commissioning arrangements apply) Policy Inclusion Criteria Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect). As tattooing is becoming more popular the number of requests for tattoo removal is increasing and is likely to continue to do so. The NHS does not routinely commission tattoo removal, unless there are clinically exceptional circumstances. Tattoo removal is not routinely commissioned for aesthetic purposes. Tattoo removal will be considered where there is evidence that: The dye has caused a significant allergic reaction and/or infection. AND All alternative treatments to manage the allergic reaction and/or infection have failed. OR A person has been given a tattoo under severe duress (sometimes called a rape tattoo ) OR It can demonstrate they (the recipient of the tattoo) were not Fraser Competent to give consent at the time they were tattooed. Funding Mechanism Individual prior approval provided the patient meets the above criteria. Requests must be submitted with all relevant supporting evidence. NOTE: Non-identifiable photographs, preferably medical illustrations if available, will be requested, to support the decision-making process, but will not form the sole basis of the decision. It is not mandatory for photographs to be provided by a patient. Clinicians can submit an individual funding request outside of this guidance if they feel there is a good case for clinical exceptionality. Requests must be submitted with all relevant supporting evidence. Clinical Exceptionality Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. Exceptionality means a person to which the general rule is not applicable. Greater Manchester sets out the following guidance in terms of determining exceptionality; however the over-riding question which the IFR process must answer is whether each patient applying for exceptional funding has demonstrated that his/her circumstances are exceptional. A patient may be able to demonstrate exceptionality by showing that s/he is: Significantly different to the general population of patients with the condition in question. and as a result of that difference GM Tattoo Removal Policy v2.2 FINAL Page 2 of 14

3 They are likely to gain significantly more benefit from the intervention than might be expected from the average patient with the condition. Best Practice Guidelines All providers are expected to follow best practice guidelines (where available) in the management of these conditions. GM Tattoo Removal Policy v2.2 FINAL Page 3 of 14

4 Contents Commissioning Statement... 2 Policy Statement... 5 Equality & Equity Statement... 5 Governance Arrangements... 5 Aims and Objectives... 5 Rationale behind the policy statement... 6 Treatment / Procedure... 6 Epidemiology and Need... 6 Adherence to NICE Guidance... 7 Audit Requirements... 7 Date of Review... 7 Glossary... 7 References... 8 Governance Approvals... 8 Appendix 1 Evidence Review Appendix 2 Diagnostic and Procedure Codes Appendix 3 Version History GM Tattoo Removal Policy v2.2 FINAL Page 4 of 14

5 Policy Statement Greater Manchester Health and Care Commissioning (GMHCC) Effective Use of Resources (EUR) Policy Team, in conjunction with the GM EUR Steering Group, have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document. In creating this policy GMHCC/GM EUR Steering Group have reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources. This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester. This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR). Equality & Equity Statement GMHCC/CCGs have 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 GMHCC/CCGs are committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, GMHCC/CCGs will have due regard to the different needs of protected characteristic groups, in line with the Equality Act This document is compliant with the NHS Constitution and the Human Rights Act This applies to all activities for which they are responsible, including policy development, review and implementation. In developing policy the GMHCC EUR Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group. The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their starting point is considered to be further back than any other group. This will be reflected in GMHCC evidencing taking due regard for fair access to healthcare information, services and premises. An Equality Analysis has been carried out on the policy. For more information about the Equality Analysis, please contact policyfeedback.gmscu@nhs.net. Governance Arrangements Greater Manchester EUR policy statements will be ratified by the Greater Manchester Joint Commissioning Board (GMJCB) prior to formal ratification through CCG Governing Bodies. Further details of the governance arrangements can be found in the GM EUR Operational Policy. Aims and Objectives This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by: reducing the variation in access to treatments/procedures. GM Tattoo Removal Policy v2.2 FINAL Page 5 of 14

6 ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness. reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester. promoting the cost-effective use of healthcare resources. Rationale behind the policy statement Tattooing is becoming increasing popular and as people change their minds about their body art or, in some cases, where it prevents them from achieving a desired life goal, then the demand for tattoo removal will also increase. There are very few clinical reasons for removing a tattoo and this procedure is therefore considered predominantly aesthetic and not routinely commissioned outside of the criteria detailed in the Commissioning Statement. Treatment / Procedure Tattooing has been a part of human culture since the earliest beginnings of modern civilization. Over the millennia the myriad of colours available has increased allowing ever more complex and colourful body art. However, over time individuals change their minds about what they think, feel, and wish to express on their skin. This results in the desire to remove the previous work of body art. The technology used to remove tattoos until recently involved destructive methods of removal resulting in scarring. The discovery of selective photothermolysis, the ability to selectively remove target structures without disrupting the surrounding skin, has made it possible to remove tattoos without destroying the surrounding skin and leaving a scar. A tattoo is a form of body modification, made by inserting indelible ink into the dermis layer of the skin to change the pigment. A laser is a device that generates an intense beam of coherent monochromatic light (or other electromagnetic radiation) by stimulated emission of photons from excited atoms or molecules. Lasers with pulse durations in the nanosecond domain are optimal for tattoo removal, and the Q- switched neodymium:yttrium-aluminum-garnet, alexandrite, and ruby lasers operate in this range and are the key tools for modern tattoo removal. If the wrong devices (operating in the millisecond range) such as intense pulsed light sources, or lasers that are non-selective, such as the carbon dioxide laser, are used to treat tattoos, this can result in significant scarring without complete removal of the tattoo. Q-switching is a technique by which a laser can be made to produce a pulsed output beam with extremely high peak power - much higher than would be produced by the same laser if it were operating in a continuous wave (CW) mode. Q-switched lasers are capable of removing tattoos without harming the skin; however removal often takes numerous treatments and still can be incomplete, especially when attempting to remove multicoloured tattoos. Epidemiology and Need A fifth of all British adults have now been inked (as contemporary usage has it). Among 16 to 44 yearolds, both men and women, the figure rises to 29%. Only 9% of over 60s have one, according to a survey of 1,000 adults by the Ask Jeeves website, but 16% of people aged between 30 and 44 have two. The survey, while not entirely scientific, is in line with a 2008 US study showing that 36% of Americans GM Tattoo Removal Policy v2.2 FINAL Page 6 of 14

7 aged 18-25, 40% of those aged and 10% of those aged have a tattoo. America, is "probably about a decade ahead in terms of popularity". Source = The Guardian, Tuesday 20 July 2010 Adherence to NICE Guidance There is no NICE guidance available. There is no guidance produced by a NICE accredited process available. Audit Requirements There is currently no national database. Service providers will be expected to collect and provide audit data on request. Date of Review Three years from the date of the last review, unless new evidence or technology is available sooner. The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review. Glossary Term Competency Checklist Example Meaning Consider: 1. Has the young person explicitly requested that you do not tell their parents/carers about the common assessment and any services that they are receiving? 2. Have you done everything you can to persuade the young person to involve their parent(s)/carer(s)? 3. Have you documented clearly why the young person does not want you to inform their parent(s)/carer(s)? 4. Can the young person understand the advice/information they have been given and have sufficient maturity to understand what is involved and what the implications are? 5. Can they comprehend and retain information relating to the common assessment and the services, especially the consequences of having or not having the assessment and services in question? 6. Can they communicate their decision and reasons for it? 7. Is this a rational decision based on their own religious belief or value system? 8. Is the young person making the decision based on a perception of reality, e.g. this would not be the case for a chaotic substance misuser? 9. Are you confident that the young person is making the decision for themselves and not being coerced or influenced by another person? 10. Are you confident that you are safeguarding and promoting the welfare of the young person? 11. Without the service(s), would the young person s physical or emotional health be likely to suffer (if applicable)? GM Tattoo Removal Policy v2.2 FINAL Page 7 of 14

8 12. Would the young persons best interests require that the common assessment is done and the identified services and support provided without parental consent? You should be able to answer YES to these questions to enable you to determine that you believe the young person is competent to make their own decisions about consenting to and taking part in the Common Assessment, sharing information and receiving services without their parent s consent. You should record the details of your decision making. Fraser Ruling (see also Gillick Competent) Gillick competent (see also Fraser Ruling) Laser Q pulsed laser Rape tattoo The legal ruling relating to the Gillick case: whether or not a child is capable of giving the necessary consent will depend on the child s maturity and understanding and the nature of the consent required. The child must be capable of making a reasonable assessment of the advantages and disadvantages of the treatment proposed, so the consent, if given, can be properly and fairly described as true consent." Gillick competence is a term originating in England and is used in medical law to decide whether a child (16 years or younger) is able to consent to his or her own medical treatment, without the need for parental permission or knowledge. A device that generates an intense beam of coherent monochromatic light (or other electromagnetic radiation) by stimulated emission of photons from excited atoms or molecules. Q-switching is a technique by which a laser can be made to produce a pulsed output beam with extremely high peak power - much higher than would be produced by the same laser if it were operating in a continuous wave (CW) mode. A tattoo inflicted on an individual against their will (often in a prison or other institution). References 1. GM EUR Operational Policy May occasionally be used where the tattoo was done prior to the individual being Gillick competent and able to give their own consent to the procedure. 2. NHS England Interim Commissioning Policy: Tattoo Removal for members of the armed forces and their families. Ref N-SC/032, NHS England (accessed 30/06/2014) Governance Approvals Name Date Approved Greater Manchester Effective Use of Resources Steering Group 19/11/2014 Greater Manchester Chief Finance Officers / Greater Manchester Directors of Commissioning May 2015 Greater Manchester Association Governing Group 02/06/2015 Bolton Clinical Commissioning Group 26/06/2015 GM Tattoo Removal Policy v2.2 FINAL Page 8 of 14

9 Bury Clinical Commissioning Group 01/07/2015 Heywood, Middleton & Rochdale Clinical Commissioning Group 17/07/2015 Manchester Clinical Commissioning Group North: 08/07/2015 Central: 30/07/2015 South: 24/06/2015 Oldham Clinical Commissioning Group 02/06/2015 Salford Clinical Commissioning Group 02/06/2015 Stockport Clinical Commissioning Group 24/06/2015 Tameside & Glossop Clinical Commissioning Group 22/07/2015 Trafford Clinical Commissioning Group 21/07/2015 Wigan Borough Clinical Commissioning Group 30/06/2015 GM Tattoo Removal Policy v2.2 FINAL Page 9 of 14

10 Appendix 1 Evidence Review Tattoo Removal GM067 Search Strategy The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; and the relevant Royal College and any other relevant bespoke sites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below: Database NHS Evidence and NICE CKS General Search (Google) Result Modernisation Agency: Information for Commissioners of Plastic Surgery Services, Referrals and Guidelines in Plastic Surgery Provider websites (not cited) Guardian article on the popularity of tattooing (not cited) WebMD guidance for patients (not cited) Medline / Open Athens Laser Tattoo Removal, Eric F. Bernstein, M.D., Seminars in Plastics Surgery/Volume 21, Number Summary of the evidence Majority of papers related to studies of the effectiveness of different methods of removal. As this is a predominantly aesthetic procedure there is very little evidence available other than papers comparing different techniques for tattoo removal. Q pulsed laser therapy appears to be the best treatment currently available. The evidence Levels of evidence Level 1 Level 2 Level 3 Level 4 Level 5 Meta-analyses, systematic reviews of randomised controlled trials Randomised controlled trials Case-control or cohort studies Non-analytic studies e.g. case reports, case series Expert opinion 1. LEVEL 5: EXPERT OPINION Modernisation Agency: Information for Commissioners of Plastic Surgery Services, Referrals and Guidelines in Plastic Surgery Tattoo Removal The NHS will consider removal of tattoos in the following cases: GM Tattoo Removal Policy v2.2 FINAL Page 10 of 14

11 Where the tattoo is the result of trauma, inflicted against the patient s will ( rape tattoo ). The patient was not Gillick competent, and therefore not responsible for their actions, at the time of the tattooing. Exceptions may also be made for tattoos inflicted under duress during adolescence or disturbed periods where it is considered that psychological rehabilitation, break up of family units or prolonged unemployment could be avoided, given the treatment opportunity. (Only considered in very exceptional circumstances where the tattoo causes marked limitations of psycho-social function). Rationale: Many patients seeking tattoo removal are from disadvantaged backgrounds that did not fully recognise the implications of a tattoo on subsequent employment and life opportunities. Most tattoos may be removed by a series of outpatient treatments using an appropriate laser. 2. LEVEL N/A: EVIDENCE BASED EXPERT OPINION Laser Tattoo Removal, Eric F. Bernstein, M.D., Seminars in Plastics Surgery/Volume 21, Number Tattooing has been a part of human culture since the earliest beginnings of modern civilization. What has changed over the millennia are the myriad of colors with which we can now express our thoughts, feelings, and desires through body art. What has not changed is human nature, and our propensity to change our minds about what it is we think, feel, and wish to express on the canvas of our skin. Our fickle nature results in the desire to change what has been placed as a permanent reminder of a friend, spouse, or as a work of art. The technology used to remove tattoos began with destructive methods of removal, which wreaked havoc not only on the tattoo but more prominently on the skin containing that tattoo. The discovery of selective photothermolysis, the ability to selectively remove target structures without disrupting the surrounding skin, made it at least possible to remove tattoos without destroying the surrounding skin and leaving a scar. Theory predicted that pulse durations in the nanosecond domain would be optimal for tattoo removal, and the Q-switched neodymium:yttrium-aluminum-garnet, alexandrite, and ruby lasers operate in this range and are the key tools for modern tattoo removal. Too often, the wrong devices operating in the millisecond range, such as intense pulsed light sources, or lasers that are non-selective, such as the carbon dioxide laser, are used to treat tattoos, resulting in significant scarring without complete removal of the tattoo. Although the Q-switched lasers are capable of removing tattoos without harming the skin, removal often takes numerous treatments and still can be incomplete, especially when attempting to remove multicolored tattoos. Developments leading to removable tattoo inks, feedback systems to detect the absorbance characteristics of tattoo inks, dermal clearing agents, and perhaps even shorter pulse-duration lasers should result in improvements in tattoo removal in the near future. GM Tattoo Removal Policy v2.2 FINAL Page 11 of 14

12 Appendix 2 Diagnostic and Procedure Codes Tattoo Removal GM067 (All codes have been verified by Mersey Internal Audit s Clinical Coding Academy) GM067 Tattoo Removal Laser destruction of lesion of skin of head or neck S09.1 Laser destruction of lesion of skin NEC S09.2 Other specified photodestruction of lesion of skin S09.8 Unspecified photodestruction of lesion of skin S09.9 With the following ICD-10 diagnosis code(s): Other specified disorders of pigmentation; (not specific to tattoo pigmentation) L81.8 GM Tattoo Removal Policy v2.2 FINAL Page 12 of 14

13 Appendix 3 Version History Tattoo Removal GM067 The latest version of this policy can be found here: GM Tattoo Removal policy Version Date Summary of Changes /06/2014 Initial draft /07/2014 Amendments made following agreement by the Greater Manchester EUR Steering Group on the 09/07/2014: Tattoo removal is not routinely commissioned for aesthetic purposes moved from Policy Exclusions section to Mandatory Criteria 3rd bullet point under mandatory criteria re-worded to state A person has been given a tattoo under duress (sometimes termed a rape tattoo ) or was not Fraser competent to give consent Inclusion of Gillick competent and Fraser ruling in the glossary. 17/09/2014 Review of feedback from consultation reviewed by Greater Manchester EUR Steering Group on 17/09/2014. No changes to the policy. Policy approved for consultation by Greater Manchester EUR Steering Group /10/2014 Branding changed following creation of North West CSU on 1/10/ /12/2014 Amendments made following discussion of the Consultation feedback by the Greater Manchester EUR Steering Group on 19/11/2014: 3 rd bullet point under Mandatory Criteria reworded to read A person has been given a tattoo under severe duress (sometimes called a rape tattoo ) or they can demonstrate they were not Fraser Competent to give consent at the time they were tattooed. Paragraph added regarding requesting of non-compulsory photographs within the standard information required if applying for clinical exceptionality added. Policy approved by GM EUR Steering Group on 19/11/2014 subject to the above changes being made /06/2015 Variance column removed and funding mechanism column added to table. Format of funding mechanism changed /04/2016 List of diagnostic and procedure codes in relation to this policy added as Appendix 2. Policy changed to Greater Manchester Shared Services template and references to North West Commissioning Support Unit changed to Greater Manchester Shared Services. Wording for date of review amended to read One year from the date of approval by Greater Manchester Association Governing Group thereafter at a date agreed by the Greater Manchester EUR Steering Group (unless stated this will be every 2 years) on Policy Statement and section 13. Date of Review /08/2016 Evidence reviewed June 2016 no new studies or reviews were found. GM EUR Steering Group agreed: No changes to policy other than the Date of Review on Policy Statement and in body of report changed to Three years from the date of last review GM Tattoo Removal Policy v2.2 FINAL Page 13 of 14

14 unless new evidence warrants earlier review. Review date added to cover page and Policy Statement /06/2018 Policy moved to new format and some wording rearranged and clarified. Commissioning Statement: (Alternative commissioning arrangements apply) added after Policy Exclusions heading Appendix 2 Added OPCS-4 codes: S09.8 Other specified photodestruction of lesion of skin & S09.9 Unspecified photodestruction of lesion of skin /01/2019 Branding changed to reflect change of service from Greater Manchester Shared Services to Greater Manchester Health and Care Commissioning. Links updated as documents have all moved to a new EUR web address. Commissioning Statement: Best Practice Guideline section added GM Tattoo Removal Policy v2.2 FINAL Page 14 of 14