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1 Natinal Imaging Assciates, Inc. Clinical guidelines SPINAL EPIDURAL INJECTIONS Original Date: Octber 2012 Page 1 f 7 CPT Cdes: Last Review Date: Octber 2014 Cervical Thracic Regin: (+77003), (+64480), 0228T (+0229T) Lumbar Sacral Regin: (+77003), (+64484), 0230T (+0231T) Guideline Number: NIA_CG_300 Last Revised Date: Octber 2014 Respnsible Department: Clinical Operatins Implementatin Date: Octber 2014 INTRODUCTION Therapeutic Spinal Epidural Injectins r Select Nerve Rt Blcks (Transframinal) are types f interventinal pain management prcedures. The therapeutic use f epidural injectins is fr shrt-term pain relief assciated with acute back pain r exacerbatin f chrnic back pain. With therapeutic injectins a crticsterid is injected clse t the target area with the gal f pain reductin. Epidural injectins shuld be used in cmbinatin with ther cnservative treatment* mdalities and nt as stand alne treatment fr lng-term back pain relief. There are different appraches used when administering spinal epidural injectins: Interlaminar epidural injectins, with sterids, access the epidural space between tw vertebrae (Interlaminar) t treat cervical, lumbar r thracic pain with radicular pain. These prcedures shuld be perfrmed using flurscpic guidance. Interlaminar epidural injectins are the mst cmmn type f epidural injectin. Transframinal epidural injectins (als called selective nerve rt blcks) access the epidural space via the intervertebral framen where the spinal nerves exit (cervical, lumbar r thracic regin). It is used bth diagnstically and therapeutically. Sme studies reprt lack f evidence and risks f transframinal epidural injectins. These prcedures are always aided with flurscpic guidance. Caudal epidural injectins, with sterids, are used t treat back and lwer extremity pain, accessing the epidural space thrugh the sacral hiatus, prviding access t the lwer nerve rts f the spine. These prcedures shuld be perfrmed using flurscpic guidance. Failed back surgery syndrme is the mst cmmn reasn fr the caudal apprach. The ratinale fr the use f spinal epidural injectins is that the surces f spinal pain, e.g., discs and jints, are accessible and amendable t neural blckade. Medical necessity management fr epidural injectins includes an initial evaluatin including histry and physical examinatin and a psychscial and functinal assessment. The fllwing must be determined: nature f the suspected rganic prblem; nnrespnsiveness t cnservative treatment*; level f pain and functinal disability; 1 Spinal Epidural Injectins Prprietary

2 cnditins which may be cntraindicatins t epidural injectins; and respnsiveness t prir interventins. Interventinal pain management specialists d nt agree n hw t diagnse and manage spinal pain; there is a lack f cnsensus with regards t the type and frequency f spinal interventinal techniques fr treatment f spinal pain. The American Sciety f Interventinal Pain Physicians (ASIPP) guidelines and Internatinal Spine Interventin Sciety (ISIS) guidelines prvide an algrithmic apprach which prvides a step-by-step prcedure fr managing chrnic spinal pain based upn evidence-based guidelines. It is based n the structural basis f spinal pain and incrprates acceptable evidence f diagnstic and therapeutic interventinal techniques available in managing chrnic spinal pain. The guidelines and algrithmic apprach referred t abve include the evaluatin f evidence fr diagnstic and therapeutic prcedures in managing chrnic spinal pain and recmmendatins fr managing spinal pain. The Indicatins and Cntraindicatins presented within this dcument are based n the guidelines and algrithmic apprach. Prir t perfrming this prcedure, shared decisin-making between patient and physician must ccur, and patient must understand the prcedure and its ptential risks and results (mderate shrt-term benefits, and lack f lng-term benefits). INDICATIONS FOR EPIDURAL INJECTIONS OR SELECTIVE NERVE BLOCKS (caudal, interlaminar, and transframinal) (Injectin f lcal anesthetics with crticsterids) Acute pain r exacerbatin f chrnic back r neck pain with the fllwing clinical timeframes: Neck r Back Pain with acute radicular pain: after 2 weeks r mre f acute radicular pain that has failed t respnd r prly respnded t cnservative management; OR Failed back surgery syndrme r Epidural fibrsis typically nt dne immediately pst-surgery : n sner than 6 mnths pst surgery patient must engage in sme frm f ther cnservative treatment* fr a minimum f 6 weeks prir t epidural injectins; OR Spinal stensis r chrnic neck r lw back pain patient must engage in sme frm f ther cnservative treatment* fr a minimum f 6 weeks prir t epidural injectins AND Average pain levels f 6 n a scale f 0 t 10 r Intermittent r cntinuus pain causing functinal disability. FREQUENCY OF REPEAT THERAPEUTIC INJECTIONS: 2 Spinal Epidural Injectins Prprietary

3 Epidural injectins may be repeated nly as medically necessary. Each epidural injectin requires an authrizatin and the fllwing criteria must be met fr repeat injectins: Dcumented prf that the prir injectin had a psitive respnse by significantly decreasing the patient s pain (at least 30-50% reductin in pain after initial injectins); AND The patient cntinues t have nging pain r dcumented functinal disability ( 6 n a scale f 0 t 10); AND The patient is actively engaged in ther frms f cnservative nn-perative treatment (unless pain prevents the patient frm participating in cnservative therapy*); AND Injectins meet the fllwing criteria: There must be at least 14 days between injectins; N mre than 3 prcedures in a 12-week perid f time per regin; Limited t a maximum ttal f 6 prcedures per regin per 12 mnths. Curse f treatment, up t three epidural injectins, regardless f apprach must prvide at least: At least 50% r mre cumulative pain relief btained fr a minimum f 6 weeks t be cnsidered a psitive and effective respnse. NOTE: Each epidural injectin requires an authrizatin. If the neural blckade is applied fr different regins (cervical and thracic regins are cnsidered as ne regin and lumbar and sacral are cnsidered as ne regin), injectins may be administered at intervals f n sner than 14 days fr mst types f prcedures. Injecting multiple regins r perfrming multiple prcedures during the same visit may be deemed medically unnecessary unless dcumentatin is prvided utlining an unusual situatin. CONTRAINDICATIONS FOR EPIDURAL INJECTIONS Bleeding diathesis and full anticagulatin (risk f epidural hematma); Severe spinal stensis resulting in intraspinal bstructin; Lcal infectin at injectin site; Predminantly psychgenic pain; Sepsis; Hypvlemia; Pregnancy; Uncntrlled diabetes; Uncntrlled glaucma; High cncentratins f lcal anesthetics in patients with multiple sclersis; Fr diagnsis r treatment f facet mediated pain; Knwn r suspected allergic reactin t sterid medicatins; 3 Spinal Epidural Injectins Prprietary

4 Spinal infectin; Malignancy; OR Acute fracture. ADDITIONAL INFORMATION: *Cnservative Therapy: (spine) shuld include a multimdality apprach cnsisting f a cmbinatin f active and inactive cmpnents. Inactive cmpnents, such as rest, ice, heat, mdified activities, medical devices, acupuncture and/r stimulatrs, medicatins, injectins (epidural, facet, bursal, and/r jint, nt including trigger pint), and diathermy can be utilized. Active mdalities may cnsist f physical therapy, a physician supervised hme exercise prgram**, and/r chirpractic care. **Hme Exercise Prgram - (HEP) the fllwing tw elements are required t meet guidelines fr cmpletin f cnservative therapy: Infrmatin prvided n exercise prescriptin/plan AND Fllw up with member with dcumentatin prvided regarding cmpletin f HEP, r inability t cmplete HEP due t physical reasn- i.e. increased pain, inability t physically perfrm exercises. (Patient incnvenience r nncmpliance withut explanatin des nt cnstitute inability t cmplete HEP). Terminlgy: Interlaminar Epidural; Selective Nerve Rt Injectin (transframinal nly); Transframinal Injectin; Injectins f Spinal Canal Hip-spine syndrme - Hip-spine syndrme is a cnditin that includes bth debilitating hip stearthritis and lw back pain. Abnrmal spinal sagittal alignment and difficulty in maintaining prper balance, as well as a wbbling gait, may be caused by severe stearthritis f the hip jint. Epidural injectins are used t determine a primary pain generatr in this cnditin. Spndyllisthesis and nerve rt irritatin - Degenerative lumbar spndyllisthesis is the displacement f a vertebra in the lwer part f the spine; ne lumbar vertebra slips frward n anther with an intact neural arch and begins t press n nerves. The mst cmmn cause, in adults, is degenerative disease althugh it may als result frm bne diseases and fractures. Degenerative spndyllisthesis is nt always symptmatic. Epidural injectins may be used t determine a previusly undcumented nerve rt irritatin as a result f spndyllisthesis. Lumbar spinal stensis with radiculitis - Spinal stensis is narrwing f the spinal clumn r f the neural framina where spinal nerves leave the spinal clumn, causing pressure n the spinal crd. The mst cmmn cause is degenerative changes in the lumbar spine. Neurgenic claudicatin is the mst cmmn symptm, referring t leg symptms encmpassing the buttck, grin and anterir thigh, as well as radiatin dwn the psterir part f the leg t the feet. In additin t pain, leg symptms can include fatigue, heaviness, weakness and/r paresthesia. Sme patients may als suffer frm accmpanying back pain. Symptms are wrse when standing r walking and are relieved by sitting. Lumbar spinal stensis is ften a disabling cnditin, and it is the mst cmmn reasn fr lumbar spinal surgery in adults ver 65 years. The mst cmmn levels f stensis are L3 thrugh L5, but 4 Spinal Epidural Injectins Prprietary

5 it may ccur at multilevels in sme patients. Radiculitis is the inflammatin f a spinal nerve rt that causes pain t radiate alng the nerve paths. Epidural injectins help t ascertain the level f the pain generatr in this cnditin. Pstperative epidural fibrsis - Epidural fibrsis is a cmmn cause f failed back surgery syndrme. With the remval f a disc, the mechanical reasn fr pain may be remved, but an inflammatry cnditin may cntinue after the surgery and may cause pain. Epidural crticsterids, with their anti-inflammatry prperties, are used t treat pstperative fibrsis and may be used alng with ral Gabapentin t reduce pain. Lumbar herniated disc - Epidural sterid injectins have been prven t be effective at reducing symptms f lumbar herniated discs. Evidence shws that they can be successful in 42% t 56% f patients wh d nt imprve after 6 weeks f cnservative treatment. Observatin and epidural sterid injectin are effective nnsurgical treatments fr this cnditin. Failed back surgery syndrme - Failed back surgery syndrme (FBSS) is characterized by persistent r recurring lw back pain, with r withut sciatica, fllwing lumbar surgery. The mst cmmn cause f FBSS is epidural fibrsis which be triggered by a surgical prcedure such as discectmy. The inflammatin resulting frm the surgical prcedure may start the prcess f fibrsis and cause pain. Epidural sterid injectins are administered t reduce pain. Discgenic pain - Discgenic pain is predminant lw back pain withut disc herniatin. 80% t 90% f lw back pain is cmmnly believed t be f unknwn etilgy. The term, discgenic disc disease, may refer t degenerative disc disease r t internal disc disruptin syndrme. Patients with the latter cnditin may have painful invertebral discs despite minimal degenerative changes. In the U.S., discgenic pain accunts fr 25% f cases f chrnic lw back pain. Evidence has shwn that epidural sterid injectins are effective fr shrt-term imprvement f discgenic pain. 5 Spinal Epidural Injectins Prprietary

6 REFERENCES Bswell, M.V., Tresct, A.M., Datta, S., Schultz, D.M., Hansen, H.C., Abdi, S. Sehgal, N.,... American Sciety f Interventinal Pain Physicians. (2007). Interventinal techniques: evidence-based practice guidelines in the management f chrnic spinal pain. Pain Physician, 10(1), ISSN Chu, R., Atlas, S.J., & Stans, S.P. (2009). Nnsurgical interventinal therapies fr lw back pain: A review f the evidence fr an American Pain Sciety Clinical Practice Guideline. Spine, 34(10), di: /BRS.0b013e3181d2ad36. Chen, S.P., Bicket, M.X., Jamisn, D., Wilkinsn, I. & Rathmell, J.P. (2013). A Cmprehensive, Evidence-Based Review: Epidural Sterids. Reginal Anesthesia and Pain Medicine, 38, 3. di: /AAP.0b013e31828ea086. Datta, S. Everett, C.R., Tresct. A.M., Schultz, D.M., Adlaka, R., Abdi, S., Atluri, S.L.,... Shah, R/V. (2007). An updated systematic review f the diagnstic utility f selective nerve rt blcks. Pain Physician, 10(1), ISSN DePalma, M.J. & Slipman, C.W. (2008). Evidence-infrmed management f chrnic lw back pain with epidural sterid injectins. The Spine Jurnal, 8(1), di: /j.spinee Genevay, S. & Atlas, S.J. (2010). Lumbar spinal stensis. Best Pract Res Clin Rheumatl 24(2), di: /j.berh Gdman, B.S., Psecin, L.W.F., Mallempati. S. & Bayazitgly, M. (2008). Cmplicatins and pitfalls f lumbar interlaminar and transframinal epidural injectins. Current Reviews in Musculskeletal Medicine, 1, di: /s Hustn, C.W. (2009). Cervical epidural sterid injectins in the management f cervical radiculitis: interlaminar versus transframinal. Current Review Musculskeletal Medicine 2(1), di: /s Institute fr Clinical Systems Imprvement (ICSI). Adult Acute and Subacute Lw Back Pain Fifteenth Editin/January Manchikanti, L., Abdi, S., Atluri, S., Benyamin, R.M., Bswell, M.V., Buenaventura, R.M., Bryce, D.A.,... Hirsch, J.A.(2013). An update f cmprehensive evidence-based guidelines fr interventinal techniques f chrnic spinal pain: Part II: Guidance and recmmendatins. Pain Physician, 16:S49-S283. ISSN Manchikanti, L., Bswell, M.V., Singh, V., Benyamin, R.M., Fellws, B., Abdi, S. Buenaventura, R.M.,... ASIPP-IPM. (2009). Cmprehensive evidence-based guidelines fr interventinal techniques in the management f chrnic spinal pain. Pain Physician, 12, ISSN Manchikanti, L., Singh, V., Cash, K.A., Pampati, V. & Datta, S. (2010). Management f pain f pst lumbar surgery syndrme: ne-year results f a randmized, duble-blind, 6 Spinal Epidural Injectins Prprietary

7 active cntrlled trial f flurscpic caudal epidural injectins. Pain Physician, 13(6), ISSN Mendza-Lattes, S., Weiss, A., Fund, E., Zimmerman, B. & Ga, Y. (2009). Cmparable effectiveness f caudal vs. transframinal epidural sterid injectins. Iwa Orthp J, 29, Retrieved frm Nrth American Spine Sciety. NASS Cverage Plicy Recmmendatins: Cervical Epidural Injectins and Diagnstic Spinal Nerve Blcks; NASS iduralinjectins.pdf Nrth American Spine Sciety. NASS Cverage Plicy Recmmendatins: Lumbar Epidural Injectins; NASS iduralinjectins.pdf Nrth American Spine Sciety. Evidence-Based Clinical Guidelines fr Multidisciplinary Spine Care: Diagnsis and Treatment f Degenerative Lumbar Spinal Stensis; 2011 Revised. ISBN X. Parr, A.T., Diwan, S. & Abdi, S. (2009). Lumbar interlaminar epidural injectins in managing chrnic lw back and lwer extremity pain: a systematic review. Pain Physician, 12(1) ISSN Spinal Epidural Injectins Prprietary

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