Commissioning Policy. The Use of Acupuncture in the Management of Musculoskeletal Pain July 2014
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- Candace Pierce
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1 Cmmissining Plicy The Use f Acupuncture in the Management f Musculskeletal Pain July 2014 This cmmissining plicy has been endrsed by and applies t patients within: NHS Suth Wrcestershire Clinical Cmmissining Grup (CCG) NHS Redditch & Brmsgrve Clinical Cmmissining Grup (CCG) NHS Wyre Frest Clinical Cmmissining Grup (CCG) Versin: V2.0 Ratified by (name and date f NHS Redditch & Brmsgrve CCG Clinical Cmmittee): Executive 07/2014 NHS Suth Wrcestershire CCG Clinical Executive 07/2014 NHS Wyre Frest CCG Clinical Executive 07/2014 Date issued: July 2014 Expiry date: (Dcument is nt valid after this date) Any revisins t the plicy will be based n lcal and natinal evidence f effectiveness and cst effectiveness tgether with recmmendatins and guidelines frm lcal, natinal and internatinal clinical prfessinal bdies. Minimum 3 yearly. Review date: July 2017 Lead Executive/Directr: Christina Emersn Head f Cmmissining & Service Redesign Name f riginatr/authr: Original Dcument Christina Emersn Updates: Helen Bryant V1.2 Fina Bates V2.0 Target audience: NHS Trusts, Independent Prviders, CCGs, GPs, Patients Distributin: NHS Trusts, Independent Prviders, CCGs, GPs and CCG Websites fr public view Equality & Diversity Impact 26 th June 2014 Assessment If yu wuld like this dcument in ther languages r frmats (i.e. large print), please cntact the Cmmunicatins Team n CCG Acupuncture Plicy V2.0 Final July 2014 Page 1 f 12
2 Cntributin list Key individuals invlved in develping the dcument Name Dr Sehar Umer Fina Bates Designatin GP Trainee WCC Medicines Cmmissining and Public Health Supprt Circulated t the fllwing individuals/grups fr cmments Name Designatin Clinical Cmmissining Plicy Cllabrative Wrcestershire Pain Management Stakehlder Grup (Versin 1.0) Review and Amendment Lg Versin Type f Change Date Descriptin f change N 1.0 Initial plicy January Minr changes July 2013 Changes t the cmmissiner reference frm NHS Wrcestershire t NHS Redditch & Brmsgrve CCG, NHS Suth Wrcestershire CCG, NHS Wyre Frest CCG 2.0 Full Review July 2014 Evidence review by Public Health Update f plicy t take int accunt ther therapies similar t acupuncture. Table f Cntents 1. Definitins Scpe f plicy: Backgrund: Relevant Natinal Guidance and Facts Evidence f Efficacy and Safety Cmmissining Plicy Clinically Exceptinal Circumstances References Dcuments Which Have Infrmed This Plicy... 8 CCG Acupuncture Plicy V2.0 Final July 2014 Page 2 f 12
3 SUMMARY Fllwing a review f the evidence and cnsideratin f the lcal circumstances fr use, Wrcestershire Clinical Cmmissining Grups endrse the prvisin f (in accrdance with this plicy): Cnventinal acupuncture fr between 6 and 10 sessins as ne f a range f interventins ffered by Physitherapists t manage musculskeletal pain. TENS as an adjunct t cre treatments ffered by Physitherapists fr shrt-term pain relief (up t 10 weeks) in patients with stearthritis. Wrcestershire Clinical Cmmissining Grups d nt supprt cmmissining f: Cnventinal acupuncture as a stand alne service frm either NHS r Independent Sectr Prviders, as a lng-term management ptin fr musculskeletal pain (beynd 10 sessins) r fr patients with Ostearthritis Transcutaneus electrical nerve stimulatin as a stand alne service r fr patients with a diagnsis ther than stearthritis. Electr-acupuncture. Any related techniques t acupuncture nt cvered by this plicy requiring additinal funding will require submissin f a new technlgy request frm fr cnsideratin by Wrcestershire Clinical Cmmissining Plicy Cllabrative. 1. Definitins 1.1 Exceptinal clinical circumstances are clinical circumstances pertaining t a particular patient, which can prperly be described as exceptinal. This will usually invlve a cmparisn with ther patients with the same clinical cnditin and at the same stage f develpment f that clinical cnditin and refer t features f the particular patient which make that patient ut f the rdinary, unusual r special cmpared t ther patients in that chrt. It can als refer t a clinical cnditin which is s rare that the clinical cnditin can, in itself, be cnsidered exceptinal. That will nly usually be the case if the NHS cmmissining bdy has n plicy which prvides fr the treatment t be prvided t patients with that rare medical cnditin. 1.2 A Similar Patient refers t the existence f a patient within the patient ppulatin wh is likely t be in the same r similar clinical circumstances as the requesting patient and wh culd reasnably be expected t benefit frm the requested treatment t the same r a similar degree. When the treatment meets the reginal criteria fr supra-ccg plicy making, then the similar patient may be in anther CCG with which the Primary Care Trust cllabrates. The existence f ne r mre similar patients indicates that a plicy psitin is required f the Primary Care Trust. 1.3 An individual funding request (IFR) is a request received frm a prvider r a patient with explicit supprt frm a clinician, which seeks funding fr a single identified patient fr a specific treatment. CCG Acupuncture Plicy V2.0 Final July 2014 Page 3 f 12
4 1.4 An in-year service develpment is any aspect f healthcare, ther than ne which is the subject f a successful individual funding request, which the Primary Care Trust agrees t fund utside f the annual cmmissining rund. Unplanned investment decisins shuld nly be made in exceptinal circumstances because, unless they can be funded thrugh disinvestment, they will have t be funded as a result f either delaying r abrting ther planned develpments. 2. Scpe f plicy: 2.1 This plicy shuld be cnsidered in line with all ther Wrcestershire Cmmissining Plicies. Cpies f these Cmmissining Plicies are available n the fllwing website address: The riginal plicy fr acupuncture was develped in Requests fr lcal cmmissining f electr-acupuncture prmpted a review f this plicy in The evidence review invlved identificatin f relevant natinal guidelines fr cnditins assciated with pain and a literature search fr the efficacy assciated with use f electr-acupuncture. These searches were infrmed by the mst prevalent causes f pain and the nature f the pain in patients presenting fr treatment. 3. Backgrund: 3.1. NHS principles have been applied in the agreement f this plicy Acupuncture is an ancient Chinese technique (dating back t 3000BC) f inserting and manipulating fine filifrm needles ( mm) int specific pints n the bdy Accrding t Chinese philsphy ur health is dependent n the bdy s mtivating energy ( Qi ) mving in a smth and balanced way thrugh a series f meridians r channels beneath the skin. Any illness r pain will disrupt the flw f Qi. The acupuncture pints used lie alng these meridians and prvide means f altering and therefre restring the flw f Qi. There are twelve main pints and these lsely crrespnd t the rgans f the bdy There are a few mdern day theries behind acupuncture. The main thery is that acupuncture stimulates the release f the bdy s natural endrphins. Several studies have prved this thery by administering nalxne (anti-dte t piids) befre the acupuncture treatment which then reduced the analgesic effect. Acupuncture is claimed t cause inhibitin at the drsal hrn by activating the descending inhibitry pathways (Shealy 1967) which is underpinned by the 'gate cntrl thery' (Melzack 1965) and stimulating release f piids and sertnin (Sluka 2003) Electr-acupuncture (als knwn as percutaneus electrical nerve stimulatin PENS) is quite similar t traditinal acupuncture in that the same pints are stimulated during treatment. As with traditinal acupuncture, needles are inserted n CCG Acupuncture Plicy V2.0 Final July 2014 Page 4 f 12
5 specific pints alng the bdy. The needles are then attached t a device that generates cntinuus electric pulses using small clips. These devices are used t adjust the frequency and intensity f the impulse being delivered, depending n the cnditin being treated. Electr-acupuncture uses tw needles at time s that the impulses can pass frm ne needle t the ther. Several pairs f needles can be stimulated simultaneusly, usually fr n mre than 30 minutes at a time Transcutaneus electrical nerve stimulatin (TENS) is the use f electric current t stimulate nerves fr therapeutic purpses. TENS by definitin cvers the cmplete range f transcutaneus applied currents used fr nerve excitatin althugh the term is ften used with a mre restrictive intent, namely t describe the kind f pulses prduced by prtable stimulatrs used t treat pain. The unit is usually cnnected t the skin using tw r mre electrdes. A typical battery-perated TENS unit is able t mdulate pulse width, frequency and intensity. Generally TENS is applied at high frequency (>50 Hz) with an intensity belw mtr cntractin (sensry intensity) r lw frequency (<10 Hz) with an intensity that prduces mtr cntractin. The tw mst cmmn applicatin mdes include: 1. High frequency r cnventinal TENS (frequency greater than 80Hz, pulse width less than 150 μsec, lw intensity sufficient t prduce a cmfrtable tingling sensatin) 2. Lw frequency r s called 'acupuncture- like' TENS (frequency less than 10Hz, pulse width greater than 150 μsec, high intensity sufficient t elicit muscle twitching) Acupuncture-like TENS is reprted t be assciated with a slwer nset and lnger duratin f analgesia cmpared t cnventinal TENS. Hwever, whether there is a significant difference in clinical effectiveness between high frequency and lw frequency mdes is unclear and nt well defined. Indeed, patient preference fr, and respnse t, different stimulatin settings may be highly individualized. Acupuncturelike TENS by definitin des nt penetrate skin. 4. Relevant Natinal Guidance and Facts 4.1. Ostearthritis (OA) NICE guideline: Ostearthritis: Care and management in adults. Issued Feb 2014 states that acupuncture shuld nt be ffered fr the management f OA. The same guideline recmmends that healthcare prfessinals shuld cnsider the use f transcutaneus electrical nerve stimulatin (TENS) as an adjunct t cre treatments fr pain relief in OA. The main evidence fr this is assciated with shrt term use, but nt fr peridic exacerbatins. Prevalence ranges frm % f the ppulatin in industrialised cuntries. Mre than 6 millin peple in the UK have painful stearthritis in ne r bth knees. Prevalence increases with age with 1 in 5 adults aged t almst 1 in every 2 adults aged 80+ having painful stearthritis in ne r bth knees The incidence f the cnditin is lw, with arund 1.5 men and 3.6 wmen develping OA per 10,000 peple per year. CCG Acupuncture Plicy V2.0 Final July 2014 Page 5 f 12
6 4.2 Chrnic Nn-Specific Back Pain NICE guideline: Early management f persistent nn-specific lw back pain. Issued May 2009 recmmends ffering drug treatments t manage pain plus a chice f physical treatments that may include acupuncture (a curse f acupuncture needling f up t 10 sessins ver up t 12 weeks) It als states that TENS shuld nt be ffered. Lw back pain is a cmmn disrder, affecting arund ne-third f the UK adult ppulatin each year. Arund 20% f peple with lw back pain (that is, 1 in 15 f the ppulatin) will cnsult their GP abut it. 5. Evidence f Efficacy and Safety 5.1 Neck Pain A Cchrane review by Trinh et al lked at 10 trials with 661 patients suffering frm neck pain fr ver 3 mnths. They shwed that acupuncture was mre effective than sham acupuncture as pain relief fr mechanical neck disrders at the end f treatment and shrt-term fllw-up The largest review n neck pain is the review by Furlan et al. published in 2012; it includes 24 acupuncture RCTs. The review shwed a psitive effect f acupuncture cmpared t n treatment but nted that sham-acupuncture cntrlled trials tended twards statistically nn-significant results. 5.2 Nn-specific Back Pain A Cchrane review lked at 35 RCTs invlving 2861 patients with nn-specific back pain lasting ver 3 mnths. They shwed that acupuncture was mre effective than n treatment at all. Again this was at the end f treatment and at shrt-term fllw up. Bth reviews cncluded that there was n difference at lng-term fllw up Thmas et al carried ut a study lking at the use f acupuncture in chrnic lwer back pain cmparing it t cnventinal treatment nly. They cncluded that acupuncture alngside cnventinal treatment was mre effective than cnventinal treatment alne A Systematic review and meta-analysis f 32 RCTs invlving patients with chrnic nn-specific back pain shwed that acupuncture had a clinically meaningful reductin in levels f self-reprted pain. Levels f functin als clinically imprved when acupuncture in additin t usual care, r electr acupuncture was cmpared with usual care alne. When acupuncture was cmpared with medicatins (NSAIDs, muscle relaxants, and analgesics) and usual care, there were statistically significant differences between the cntrl and the interventin grups but these differences were t small t be f any clinical significance. There was n evidence in supprt f acupuncture ver transcutaneus electrical nerve stimulatin 5.3 Rheumatid Arthritis The Cchrane Cllabratin reviewed acupuncture and electr acupuncture fr the treatment f rheumatid arthritis in Due t the small number and pr quality f studies, they fund n evidence t recmmend use f either CCG Acupuncture Plicy V2.0 Final July 2014 Page 6 f 12
7 acupuncture r electr-acupuncture fr this cnditin. Althugh the results f the study n electr-acupuncture shw that electracupuncture may be beneficial t reduce symptmatic knee pain in patients with RA 24 hurs and 4 mnths pst treatment, the reviewers cncluded that the pr quality f the trial, including the small sample size preclude its recmmendatin. The reviewers further cnclude that acupuncture has n effect n pain, patient's glbal assessment, number f swllen jints, number f tender jints, general health, disease activity and reductin f analgesics. These cnclusins are limited by methdlgical cnsideratins such as the type f acupuncture (acupuncture vs electr-acupuncture), the site f interventin, the lw number f clinical trials and the small sample size f the included studies". 5.4 Ostearthritis A 2012 Centre fr Reviews and Disseminatin (CRD) netwrk meta-analysis n the relief f chrnic pain due t stearthritis f the knee included 22 acupuncture RCTs. The reprt, cmparing different physical treatments, cncluded that acupuncture is ne f a number f physical treatments that prduces a clinically-relevant effect in alleviating pain in the shrt-term. Research is needed t evaluate lng-term benefits f the treatments, as well as their relative effects amng diverse patient subgrups 5.5 It shuld be nted that the majrity f the studies lked at cnclude with the fact that there is little evidence t supprt r refute acupuncture due t a small number f trials which are all clinically and methdically diverse. There are many reasns fr this. Firstly, the severity f an individual s pain can nly be measured using the patient s perceptin t that pain and there is n quantitative measure fr this. The ther difficulty is carrying ut blinded randmised cntrlled trials because unlike trials invlving drugs where a placeb pill can be given, it is mre difficult t give placeb acupuncture. Althugh sham acupuncture treatments were used in sme trials, it is difficult t knw whether r nt there is a psychlgical aspect invlved and als whether the sham acupuncture actually causes sme srt f physilgical prcess, thereby reducing pain. 5.6 A number f smaller scale studies have been published in relatin t the use f electr-acupuncture in the treatment f Fibrmyalgia, Neurpathic Pain, Pst- Surgical Pain and Depressin. Hwever the studies tend t be f pr methdlgical quality and subject t publicatin bias, therefre it is nt pssible t make any firm decisin t fund electr-acupuncture specifically fr any f these cnditins. 5.7 There is limited evidence assciated with use f electr-acupuncture and insufficient with which t recmmend its use in clinical practice. There is n evidence that electr-acupuncture ffers any advantages ver acupuncture. 6. Cmmissining Plicy 6.1 NHS Redditch & Brmsgrve Clinical Cmmissining Grup, NHS Suth Wrcestershire Clinical Cmmissining Grup and NHS Wyre Frest Clinical Cmmissining Grup (termed the Cmmissiners ) cnsider all lives f all patients whm it serves t be f equal value and, in making decisins abut funding treatment fr patients, will seek nt t discriminate n the grunds f sex, age, sexual rientatin, ethnicity, educatinal level, emplyment, marital status, religin r CCG Acupuncture Plicy V2.0 Final July 2014 Page 7 f 12
8 disability except where a difference in the treatment ptins made available t patients is directly related t the patient s clinical cnditin r is related t the anticipated benefits t be derived frm a prpsed frm f treatment. 6.2 Acupuncture is nt cmmissined as a stand alne service frm either NHS r Independent Sectr Prviders. Acupuncture will be available as ne f a range f interventins ffered by Physitherapists t manage musculskeletal pain. 6.3 Acupuncture is mre ften used as part f a patient s treatment package rather than a single interventin in its wn right, as a step-up t reduce pain and enable patients t self manage. Patient may be ffered between 6 and a maximum f 10 sessins f acupuncture used alngside cnventinal pain management therapy e.g. analgesia. 6.4 Acupuncture treatment is nt supprted as a lng term management ptin fr musculskeletal pain (beynd 10 sessins) r fr patients with Ostearthritis. 6.5 Trans-cutaneus electrical nerve stimulatin is nt cmmissined as a stand alne service frm either NHS r Independent Sectr Prviders. It may be ffered by Physitherapists as an adjunct t cre treatments fr shrt-term pain relief (up t 10 weeks) in patients with stearthritis. 6.6 Electr-acupuncture is nt supprted due t lack f rbust evidence f clinical efficacy. 7. Clinically Exceptinal Circumstances 7.1 If there is demnstrable evidence f a patient s clinically exceptinal circumstances, the referring practitiner shuld refer t the Cmmissiner s Operatinal Plicy fr Individual Funding Requests dcument fr further guidance n the prcess fr cnsideratin. Fr a definitin f the term clinically exceptinal circumstances, please refer t the Definitins sectin f this dcument. 8. References Wrcestershire Clinical Plicy Cllabrative. Evidence review electracupuncture fr management f pain. March Dcuments Which Have Infrmed This Plicy Wrcestershire CCGs: Operatinal Plicy fr Individual Funding Requests Wrcestershire CCGs: Priritisatin Framewrk fr the Cmmissining f Healthcare Services West Midlands Strategic Grup Cmmissining Plicy 1: Guiding principles and cnsideratins t underpin pririty setting and resurce allcatin within cllabrative cmmissining arrangements CCG Acupuncture Plicy V2.0 Final July 2014 Page 8 f 12
9 West Midlands Strategic Grup Cmmissining Plicy 4: Use f csteffectiveness, value fr mney and cst effectiveness threshlds West Midlands Strategic Grup Cmmissining Plicy 16: Prir Apprval West Midlands Strategic Grup Cmmissining Plicy 9: Individual funding requests CCG Acupuncture Plicy V2.0 Final July 2014 Page 9 f 12
10 Equality Impact Assessment Department Public health Name f persn cmpleting EIA Dr Sehar Umar Supprted by Jennifer Weigham NHS Arden CSU Date f EIA 26/06/2014 Accuntable CCG Lead CCG Sign ff and date Piece f wrk being assessed Aims f this piece f wrk The Use f Acupuncture in the Management f Musculskeletal Pain T assess the impact f the plicy n all f the prtected grups. Other partners/stakehlders invlved Wh will be affected by this piece f wrk? The patients within Wyre Frest CCG, Redditch and Brmsgrve CCG and Suth Wrcestershire CCG. Single Equality Scheme Strand Gender Race Baseline data and research n the ppulatin that this piece f wrk will affect. What is available? Eg ppulatin data, service user data. What des it shw? Are there any gaps? Use bth quantitative data and qualitative data where pssible. Include cnsultatin with service users wherever pssible Rheumatid arthritis affects wmen far mre ften than men. In fact, abut 70 t 80 percent f peple affected by the autimmune disease are female. Females are als mre likely t develp Ostearthritis (OA); accrding t the Centres fr Disease Cntrl and Preventin, men have a 45 percent lwer risk f knee OA and a 36 percent lwer risk f hip OA than wmen. The fllwing evidence was prvided frm the research referenced belw: The risks f develping SLE and RA vary with ethnic rigin. Prevalence f lupus has been fund t be up t eight times higher in African-American and Afr- Caribbean ppulatins than in peple f Eurpean descent. The cnsistency with which high prevalence f lupus ccurs in ppulatins f west African descent wh are living in different envirnments suggests that genetic factrs are likely t underlie the high risk in this grup. The high risk fr lupus in west Africans cmpared with in Eurpeans des nt appear t be accunted fr by differences in allele frequencies at any f the lci at which assciatins with SLE have been fund, including thse in the HLA regin. Other ppulatins at high risk fr lupus include Pacific islanders and Chinese-Americans, with prevalence rates up t three times higher than in peple f Eurpean descent living in the same cuntries. Fr RA, the highest risks are recrded fr Native American ppulatins, in which prevalence is up t fur times higher than it is in Eurpeans. Althugh the frequency f alleles that cde fr the high-risk 'shared epitpe' at Is there likely t be a differential impact? Yes, n, unknwn. Yes Yes CCG Acupuncture Plicy V2.0 Final July 2014 Page 10 f 12
11 the HLA-DRB1 lcus is higher in Native Americans than in Eurpeans, this nly accunts fr a ppulatin risk rati f abut 1.4, cmpared with the bserved risk ratis f arund 4. Where there has been a mixture between ethnic grups that differ in risk fr disease, studies f hw the risk fr disease varies with prprtinate admixture can help t distinguish between genetic and envirnmental explanatins fr the difference in disease risk and can help t define the genetic mdel. N adequate studies have yet been undertaken n the risk fr lupus in relatin t admixture in ppulatins f mixed Eurpean/west African descent, r n the risk fr RA in relatin t admixture in ppulatins f mixed Eurpean/Native American descent. If ethnic differences in risk fr lupus and RA have a genetic basis, it is pssible in principle t map the genes that underlie ethnic differences in risk by studying affected individuals f mixed descent. This apprach is an extensin f the methds used fr linkage analysis f a crss in experimental genetics. Befre this can be applied in practice, it is necessary t assemble sets f marker plymrphisms that can be used t assign ancestry n chrmsmes f mixed descent. Ethnic variatin in risk fr rheumatic disease. Studying ethnic variatin in disease risk can yield clues t envirnmental r genetic factrs that influence disease risk. Where variatins in risk between ppulatins have been identified, studies f migrants between lw-risk and high-risk areas can help t distinguish between genetic and envirnmental explanatins fr these differences in risk, and t determine the age at which risk is set. If an ethnic difference in disease risk has an envirnmental explanatin, this difference is expected t 'wear ff' within a few generatins after migratin. Fr instance, the lw risk fr multiple sclersis in trpical cuntries cmpared with the risk in nrthern latitudes persists in thse wh migrate frm trpical cuntries t the UK as adults, but in secnd-generatin migrants the risk fr multiple sclersis is similar t that in the hst ppulatin. If, n the ther hand, genetic factrs underlie an ethnic difference in disease risk, we wuld expect this ethnic difference t persist in ppulatins where migrants have been settled verseas fr many generatins, and t be bserved cnsistently in all cuntries where a given migrant grup has settled. Disability Thse with a physical disability may be s as it is cnnected t arthritis r back pain. Yes Religin/ belief An individual s religin shuld nt be cnnected t risk factrs fr arthritis and back pain. N Sexual An individual s sexual rientatin shuld nt be cnnected t risk factrs fr arthritis and back pain. N rientatin Age Older peple are mre affected and likely t develp MS pain. Yes Scial Obesity is a risk factr t develping arthritis. RH is genetic s nt sci-ecnmic factr. Yes deprivatin Carers Human rights An individual s caring respnsibility may make them mre likely t develp OA and chrnic back pain if part f their respnsibilities is lifting/pushing manual handling etc. Yes N CCG Acupuncture Plicy V2.0 Final July 2014 Page 11 f 12
12 Equality Impact Assessment Actin Plan CCG Strand Issue Suggested actin(s) Hw will yu measure the utcme/impact Timescale Lead Gender Females mre likely t N/A N/A N/A N/A develp OA and RA This is a bilgical/clinical fact. Race Arthritis is affected by ethnic rigin Evidence suggests that early interventin is beneficial in patients with early inflammatry arthritis. Guidance prmtes early referral and cnsultatin f all patients with suspected inflammatry arthritis and lcal clinical guidance and referral frms have been develped and are being pilted. This apprach des nt differentiate between patients f different ethnic rigins and will ensure that all N/A N/A N/A Disability Age Scial Deprivatin Carers Arthritis is a cnditin which can cause an individual t becme physically less able. Older peple are mre at risk f develping related cnditins. Obesity affects strain n jints and is a risk factr fr OE Carers may be mre prne t develp nn-specific back pain thse at risk are managed equally and effectively. N/A These tw issues are intertwined and are inherent f each ther N/A This is a bilgical/clinical fact that is part f the ageing prcess wear and tear f jints. Obesity is being tackled in the cmmunity with different Public health prgrammes which include Breast feeding supprt, healthy eating interventin fcusing n skills develpment and behaviural change, Walking prmtin initiatives including walking buses, Prvisin f healthier fd chices in the wrkplace etc Raise issue with Public Health wh are respnsible fr this aspect f care. N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A CCG Acupuncture Plicy V2.0 Final July 2014 Page 12 f 12
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