Medical Policy Discectomy. Description. Related Policies. Policy. Effective Date February 27, Subsection. 7.

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1 Medical Plicy Discectmy Sectin 7.0 Surgery Subsectin Effective Date February 27, 2015 Original Plicy Date February 27, 2015 Next Review Date February 2016 Descriptin Discectmy is a surgical prcedure in which 1 r mre intervertebral discs are remved. Extrusin f an intervertebral disc beynd the intervertebral space can cmpress the spinal nerves and result in symptms f pain, numbness and weakness. Discectmy is intended t treat symptms by relieving pressure n the affected nerve(s). Discectmy can be perfrmed by a variety f surgical appraches, with either pen surgery r minimally invasive techniques. Related Plicies Artificial Intervertebral Disc: Cervical Spine Artificial Intervertebral Disc: Lumbar Spine Autmated Percutaneus and Endscpic Discectmy Decmpressin f the Intervertebral Disc Using Laser Energy (Laser Discectmy) r Radifrequency Cblatin (Nucleplasty) Percutaneus Intradiscal Electrthermal Annulplasty and Percutaneus Intradiscal Radifrequency Annulplasty Vertebral Axial Decmpressin Plicy CURRENT The fllwing psitin statement is effective thrugh April 29, 2015 Lumbar discectmy (see Plicy Guidelines) may be cnsidered medically necessary fr the treatment f lumbar herniated disc when all f the fllwing criteria are met: Signs and symptms f radiculpathy n histry and physical exam (see Plicy Guidelines) One f the fllwing clinical presentatins is present: Rapidly prgressing neurlgic deficits Persistent debilitating back r leg pain that is refractry t at least 6 weeks f cnservative therapy (see Plicy Guidelines) Dcumentatin f nerve rt cmpressin n imaging (magnetic resnance imaging [MRI] r cmputed tmgraphy [CT]) at a level that crrespnds with the patient s symptms (see Plicy Guidelines) Lumbar discectmy is cnsidered nt medically necessary fr the treatment f lumbar herniated disc when the abve criteria are nt met. 1

2 Medical Plicy Cervical discectmy (see Plicy Guidelines) may be cnsidered medically necessary fr the treatment f cervical herniated disc when all f the fllwing criteria are present: Signs and symptms f radiculpathy and/r myelpathy n histry and physical exam (see Plicy Guidelines) One f the fllwing clinical presentatins is present: Rapidly prgressing neurlgic deficits Persistent debilitating neck, back, r arm pain that is refractry t at least 6 weeks f cnservative therapy (see Plicy Guidelines) Persistent r prgressive symptms f myelpathy that are refractry t at least 6 weeks f cnservative therapy (see Plicy Guidelines) Dcumentatin f nerve rt cmpressin n imaging (MRI r CT) at a level that crrespnds with the patient s symptms (see Plicy Guidelines) Cervical discectmy is cnsidered nt medically necessary fr the treatment f cervical herniated disc when the abve criteria are nt met. Thracic discectmy may be cnsidered medically necessary fr patients with any f the fllwing cnditins and assciated criteria (as applicable): Dcumentatin f significant r prgressive neurlgical lss including mtr deficits and/r sensry changes/disturbances Thracic radiculpathy and all f the fllwing: Dcumentatin f severe intractable pain with debilitating thracic radiculpathy (e.g., lcalized r radiating pain in a girdle-like fashin alng the intercstal dermatme and/r ncturnal recumbent pain) f at least six (6) weeks in duratin with clear evidence f a neural cmpressive lesin/nerve rt cmprmise which crrelates with the clinical examinatin findings Cnditin crrelates with the diagnstic imaging findings Patient is unrespnsive t a curse f an active rehabilitative exercise prgram with apprpriate adjunctive care (e.g., physical therapy, chirpractic care, pain management) Thracic discectmy is cnsidered nt medically necessary when the abve criteria specified are nt met. Discectmy is cnsidered investigatinal fr all ther indicatins. PREVIEW The fllwing psitin statement will take effect n April 30, 2015 Lumbar discectmy (see Plicy Guidelines) may be cnsidered medically necessary fr the treatment f lumbar herniated disc when all f the fllwing criteria are met: Signs and symptms f radiculpathy n histry and physical exam (see Plicy Guidelines) One f the fllwing clinical presentatins is present: Rapidly prgressing neurlgic deficits Persistent debilitating back r leg pain that is refractry t at least 6 weeks f cnservative therapy (see Plicy Guidelines) 2

3 Medical Plicy Dcumentatin f nerve rt cmpressin n imaging (magnetic resnance imaging [MRI] r cmputed tmgraphy [CT]) at a level that crrespnds with the patient s symptms (see Plicy Guidelines) Lumbar discectmy is cnsidered nt medically necessary fr the treatment f lumbar herniated disc when the abve criteria are nt met. Cervical discectmy (see Plicy Guidelines) may be cnsidered medically necessary fr the treatment f cervical herniated disc when all f the fllwing criteria are present: Signs and symptms f radiculpathy and/r myelpathy n histry and physical exam (see Plicy Guidelines) One f the fllwing clinical presentatins is present: Rapidly prgressing neurlgic deficits Persistent debilitating neck, back, r arm pain that is refractry t at least 6 weeks f cnservative therapy (see Plicy Guidelines) Persistent r prgressive symptms f myelpathy that are refractry t at least 6 weeks f cnservative therapy (see Plicy Guidelines) Dcumentatin f nerve rt cmpressin n imaging (MRI r CT) at a level that crrespnds with the patient s symptms (see Plicy Guidelines) Cervical discectmy is cnsidered nt medically necessary fr the treatment f cervical herniated disc when the abve criteria are nt met. Discectmy is cnsidered investigatinal fr all ther indicatins. Plicy Guidelines Lumbar Discectmy Lumbar discectmy refers t standard pen discectmy r minimally invasive micrdiscectmy. Micrdiscectmy will be defined fr the purpse f this assessment as having the fllwing features: 1. Uses a small surgical incisin (as ppsed t an endscpic prt ) 2. Uses a specially designed micrscpe t achieve direct visualizatin f the vertebral clumn (as ppsed t indirect visualizatin with an endscpe r ther type f cameras) 3. Remves disc and ther surgical prducts by direct visualizatin thrugh the surgical incisin Micrdiscectmy Micrdiscectmy may be dne with adjunctive devices, such as tubular retractrs t imprve visualizatin, r endscpy t lcalize the crrect areas t perate. Hwever, remval f the disc itself must be dne under direct visualizatin in rder t be cnsidered micrdiscectmy. Cervical Discectmy Cervical discectmy refers t pen anterir cervical discectmy (with r withut fusin), r minimally invasive psterir cervical discectmy/framintmy. 3

4 Medical Plicy Alternative Prcedures There are numerus ther alternative prcedures fr perfrming discectmy, with uncertain efficacy cmpared with standard prcedures. Fr the purpse f this reference plicy, the fllwing prcedures are cnsidered investigatinal and therefre nt valid alternatives fr discectmy: Artificial intervertebral disc (lumbar and cervical) Laser discectmy Radifrequency cblatin (nucleplasty) Autmated percutaneus discectmy Endscpic discectmy Intradiscal electrthermal annulplasty (IDET) Intradiscal radithermal annulplasty Chemnuclelysis Radiculpathy The diagnsis f radiculpathy is typically made by a cmbinatin f suggestive signs and symptms in cnjunctin with imaging that demnstrates cmpressin f a spinal nerve rt. Symptms are due t irritatin f the spinal nerve rt (e.g., L4, L5, r S1). Fr the purpse f this plicy, radiculpathy is defined as the presence f any f the fllwing: 1. Lss f strength f specific named muscle(s) r mytmal distributin(s) demnstrated n detailed neurlgic examinatin (within the prir 3 mnths) cncrdant with nerve rt cmpressin f the invlved named spinal nerve rt(s). 2. Altered sensatin t light tuch, pressure, pin prick, r temperature demnstrated n a detailed neurlgic examinatin (within the prir 3 mnths) in the sensry distributin cncrdant with nerve rt cmpressin f the invlved named spinal nerve rt(s). 3. Diminished, absent r asymmetric reflex(es) within the prir 3 mnths cncrdant with nerve rt cmpressin f the invlved named spinal nerve rt(s). 4. Pain r ther dysaesthesia/paraesthesia reprted by the patient in a sensry distributin(s) (specific dermatne[s]) f the invlved named spinal nerve rt(s) with either f the fllwing: a. A cncrdant radilgist s interpretatin f an advanced diagnstic imaging study (MRI r CT) f the spine demnstrating cmpressin f the invlved named spinal nerve rt(s). (Perfrmed within the past 12 mnths) b. Electrdiagnstic studies (EMG/NCV s) diagnstic f nerve rt cmpressin f the invlved named spinal nerve rt(s). (Perfrmed within the past 12 mnths) Cnservative Nnsurgical Therapy Cnservative nnsurgical therapy fr the duratin specified shuld include all f the fllwing: 4

5 Medical Plicy Use f prescriptin strength analgesics fr several weeks at a dse sufficient t induce a therapeutic respnse Analgesics shuld include anti-inflammatry medicatins with r withut adjunctive medicatins such as nerve membrane stabilizers r muscle relaxants Participatin in at least 6 weeks f physical therapy (including active exercise) r dcumentatin f why the patient culd nt tlerate physical therapy Evaluatin and apprpriate management f assciated cgnitive, behaviral, r addictin issues Dcumentatin f patient cmpliance with the preceding criteria Persistent Debilitating Pain Persistent debilitating pain is defined as: Significant level f pain n a daily basis defined n a visual analg scale (VAS) as greater than 4; AND Pain n a daily basis that has a dcumented impact n activities f daily living in spite f ptimal cnservative nnsurgical therapy as utlined abve and apprpriate fr the patient Medical Necessity Dcumentatin Medical necessity is established by dcumentatin f medical histry, physical findings, and diagnstic imaging results that demnstrate spinal nerve cmpressin and supprt the surgical treatment interventin. Dcumentatin in the medical recrd must clearly supprt the medical necessity f the surgery and include the fllwing infrmatin: Medical Histry Patient has been screened/evaluated fr clinically significant medical cmrbidities (e.g., mrbid besity, current smking, diabetes, renal disease, steprsis, and severe physical decnditining) and undergne thrugh medical clearance, if applicable Dcumentatin frm a primary care physician, neurlgist, physiatrist, psychiatrist r psychlgist, supprts the absence f untreated, underlying psychlgical cnditins r psychscial issues (e.g., depressin, drug and alchl abuse) as cntributrs t chrnic pain Histry f back surgery, including minimally invasive back prcedures Prir trial, failure, r cntraindicatin t cnservative medical/nn-perative interventins that may include but are nt limited t the fllwing: Physical Examinatin Activity mdificatin fr at least 6 weeks Oral analgesics and/r anti-inflammatry medicatins Physical therapy Chirpractic manipulatin Epidural sterid injectins Clinical findings including the patient s stated symptms and duratin 5

6 Medical Plicy Diagnstic Testing Radilgist s reprt f a magnetic resnance image (MRI) r cmputerized tmgraphy (CT) scan with myelgram f the lumbar spine within the past 12 mnths shwing a lumbar spine abnrmality Reprt f the selective nerve rt injectin results, if applicable t the patient s diagnstic wrkup Benefit Applicatin Benefit determinatins shuld be based in all cases n the applicable cntract language. T the extent there are any cnflicts between these guidelines and the cntract language, the cntract language will cntrl. Please refer t the member's cntract benefits in effect at the time f service t determine cverage r nncverage f these services as it applies t an individual member. Sme state r federal mandates (e.g., Federal Emplyee Prgram (FEP)) prhibit Plans frm denying Fd and Drug Administratin (FDA) - apprved technlgies as investigatinal. In these instances, plans may have t cnsider the cverage eligibility f FDA-apprved technlgies n the basis f medical necessity alne. Ratinale Backgrund Discectmy is a surgical prcedure in which 1 r mre intervertebral discs are remved. The primary indicatin fr discectmy is herniatin, r extrusin, f an intervertebral disc. Extrusin f an intervertebral disc beynd the intervertebral space can cmpress the spinal nerves and result in symptms f pain, numbness and weakness. Discectmy is intended t treat symptms by relieving pressure n the affected nerve(s). Hwever, nt all disc herniatins require surgery. The natural histry f untreated disc herniatins is nt well-characterized, but mst disc herniatins will decrease in size ver time due t shrinking and/r regressin f the disc.(1) Clinical symptms will als tend t imprve ver time in cnjunctin with shrinkage r regressin f the herniatin. Because mst disc herniatins imprve ver time, initial care is cnservative, cnsisting f analgesics and a prescribed activity prgram tailred t the patient s individual cnsideratins. Other ptential nnsurgical interventins include piid analgesics and chirpractic manipulatin. Epidural sterid injectins can als be used as a secnd-line interventin and are assciated with shrt-term relief f symptms.(2) Hwever, sme disc herniatins will nt imprve ver time with cnservative care. A small prprtin f patients will have rapidly prgressive signs and symptms, thus putting them at risk fr irreversible neurlgic deficits. These patients are cnsidered t be surgical emergencies and expedient surgery is intended t prevent further neurlgic deteriratin and allw fr nerve recvery. Other patients will nt prgress, but will have the persistence f symptms that require further interventin. It is estimated that up t 30% f patients with sciatica will cntinue t have pain fr mre than 1 year.(3) Fr these patients, there is a high degree f mrbidity and functinal disability assciated with chrnic back pain, and there is a tendency fr recurrence despite the mdality f treatment. Therefre, treatments that have mre 6

7 Medical Plicy unifrm efficacy fr patients with herniated disc and chrnic back pain are needed. In particular, decreased chrnic pain and decreased disability is the gal f treatment f chrnic lw back pain due t herniated disc. Lumbar Discectmy Lumbar discectmy can be perfrmed by a variety f surgical appraches. Open discectmy is the traditinal apprach. In pen discectmy, a 2 t 3 cm incisin is made ver the area t be repaired. The spinal muscles are dissected and a prtin f the lamina may be remved t allw access t the vertebral space. The extruded disc is remved either entirely r partially using direct visualizatin. Ostephytes that are prtruding int the vertebral space can als be remved if deemed necessary. The main alternative t pen discectmy is micrdiscectmy, which has gained ppularity ver the last few decades. A micrdiscectmy is a minimally invasive prcedure that invlves a smaller incisin, visualizatin f the disc thrugh a special camera, and remval f disc fragments using special instruments. The amunt f resectin that can be perfrmed in a micrdiscectmy is less and therefre is usually reserved fr smaller herniatins in which a smaller amunt f tissue needs t be remved. A few cntrlled trials f pen discectmy versus micrdiscectmy have been published, and have reprted that neither prcedure is clearly superir t the ther but that micrdiscectmy is assciated with mre rapid recvery.(4,5) Cervical Discectmy The mst cmmn prcedure fr cervical discectmy is anterir cervical discectmy (ACD). This is an pen prcedure in which the cervical spine is apprached thrugh an incisin in the anterir neck. Sft tissues and muscles are separated t expse the spine. The disc is remved using direct visualizatin. This prcedure can be dne with r withut spinal fusin, but mst cmmnly it is perfrmed tgether with fusin. An alternate, less invasive prcedure fr cervical discectmy is psterir cervical discectmy/framintmy. This is perfrmed thrugh a small incisin in the back f the neck. The nerves and muscles are separated using a small retractr. The spine is visualized with micrscpic guidance, and a prtin f the spine, the framen, is remved t expse the spinal canal. Special instruments are used t remve a prtin f the disc r the entire disc. Cmplicatins f discectmy in general include bleeding, infectins, and inadvertent nerve injuries. Dural puncture ccurs in a few percent f patients, leading t leakage f cerebrspinal fluid that can be accmpanied by headaches and/r neck stiffness. In a small percentage f cases, wrsening f neurlgic symptms can ccur pstsurgery. Other variatins n discectmy include the fllwing prcedures. These prcedures d nt have high-quality cmparative trials cmpared with standard discectmy, have all been determined investigatinal in the separate medical plicies (see Related Plicies), and will therefre nt be cnsidered as true alternatives t discectmy fr this reference plicy: Artificial intervertebral disc (lumbar and cervical) Laser discectmy Radifrequency cblatin (nucleplasty) Autmated percutaneus discectmy Autmated endscpic discectmy 7

8 Medical Plicy Autmated percutaneus discectmy Intradiscal electrthermal therapy (IDET) annulplasty Intradiscal radithermal therapy annulplasty Vertebral axial decmpressin Chemnuclelysis Regulatry Status Discectmy is a surgical prcedure and, as such, is nt subject t regulatin by the U.S. Fd and Drug Administratin (FDA). Sme f the instrumentatin used during laminectmy may be subject t FDA apprval. Literature Review Assessment f efficacy fr therapeutic interventins invlves a determinatin f whether the interventin imprves health utcmes. The ptimal study design fr this purpse is a randmized cntrlled trial (RCT) that includes clinically relevant measures f health utcmes. Intermediate utcme measures, als knwn as surrgate utcme measures, may als be adequate if there is an established link between the intermediate utcme and true health utcmes. Nnrandmized cmparative studies and uncntrlled studies can smetimes prvide useful infrmatin n health utcmes, but are prne t biases such as nncmparability f treatment grups, placeb effect, and variable natural histry f the cnditin. The best evidence n the efficacy f discectmy cnsists f several RCTs cmparing discectmy with cnservative care, and systematic reviews f these trials. The RCTs frm the main bdy f evidence fr evaluating the efficacy f discectmy. Hwever, cnducting high-quality RCTs fr this cnditin is challenging due t strng preferences fr treatment n the part f bth patients and physicians. This leads t difficulty enrlling a ppulatin that is representative f patients seen in clinical care, and als t high rates f crssver between treatment grups fllwing randmizatin. Fr this reasn, it is imprtant t evaluate evidence frm nnrandmized cmparative trials. Sme f the representative, larger nnrandmized cmparative studies are als included in the review f evidence. Lumbar Discectmy Randmized Cntrlled Trials A ttal f 6 RCTs f discectmy versus cnservative care were initially identified. One f these was frm 1983 and was nt included because it was unlikely that results reflect current surgical management.(6) Anther RCT cmpared percutaneus discectmy with cnservative care.(7) Because percutaneus discectmy is cnsidered investigatinal (see Blue Shield f Califrnia Medical Plicy: Autmated Percutaneus and Endscpic Discectmy [ ]), this study was als excluded, leaving 4 RCTs fr review. The SPORT Trial This mderately large-sized trial cmpared discectmy with nnperative care in patients with lumbar disc herniatin and included bth a randmized and nnrandmized cmpnent.(8,9) The randmized cmpnent included 501 patients randmly assigned t either discectmy r usual care. Discectmy was perfrmed by the pen technique fr all patients, and in sme cases, the medial brder f the superir facet jint was remved. Crssver was allwed, and during the curse f the study 107 f 245 (45%) patients assigned t usual care underwent surgery, and 140 f 245 (60%) 8

9 Medical Plicy patients assigned t the surgery grup underwent surgery. The main utcmes were the 36-Item Shrt-Frm Health Survey (SF-36) and the Oswestry Disability Index (ODI) measured at 3 mnths, 1 year, and 2 years. Secndary utcmes included self-reprted imprvement, wrk status, satisfactin with care, and a symptm severity measure (Sciatica Bthersmeness Index). Fr the primary utcmes analyzed n intentin-t-treat (ITT) analysis, imprvement in the ODI was superir fr the surgery grup at 3 mnths, but at the 1 year and 2 year time pints, there were n significant grup differences n any f the primary utcmes. Fr the secndary utcmes, there were significant imprvements fr the surgery grup n the Sciatica Bthersmeness Index at all time pints, and satisfactin with care was superir fr the surgery grup at 3 mnths, but nt at lnger time pints. A secndary analysis was perfrmed n a treatment-received basis, and this analysis shwed significantly greater imprvements fr the surgery grup at all time pints. The estimated treatment effect fr the SF-36 Bdily Pain and Physical Functin scales with 15.0 and 17.5, respectively, n a 0 t 100 scale. The estimated treatment effect n the ODI was n a 0 t 100 scale. Leiden-The Hague Spine Interventin Prgnstic Study This was a multicenter RCT perfrmed at 11 hspitals in the Netherlands cmparing immediate surgery with cntinued cnservative care and surgery as necessary.(10) Patients were eligible if they were 18 t 65 years-ld, had severe sciatica fr between 6 and 12 weeks, and had radilgically cnfirmed disc herniatin. A ttal f 283 patients were randmized and fllwed fr 1 year. Patients in the surgery grup were treated with micrdiscectmy, and patients in the cnservative care grup received cntinued cnservative care frm their primary care prviders. The primary utcmes were the Rland-Mrris Disability Questinnaire fr sciatica, leg pain rating n a 0-t-100 visual analg scale (VAS), and self-rating f perceived recvery n a 7-pint Likert scale. Secndary utcmes included bservatinal assessment f neurlgic status and disability, the SF-36, and sciatica symptm scales. By the end f the study, 89% f the surgical grup underwent surgery, and f the 142 patients assigned t initial cnservative care, 55 (39%) had undergne surgery at 1 year. At early fllw-up, there were sme differences in favr f the surgery grup. At 8 and 12 weeks, the surgery grup had superir scres n disability and leg pain, and back pain was superir fr the surgery grup between 2 and 26 weeks. Hwever, at 1-year fllwup, the scres were similar between grups with n significant grup differences. Fr the utcme f perceived recvery, the median time t recvery was shrter in the surgery grup (4.0 weeks; 95% cnfidence interval [CI], 3.7 t 4.4) cmpared with the cnservative care grup (12.1 weeks; 95% CI, 9.5 t 14.9). At 1 year, the recvery rates were equivalent between grups, with 95% f patients reprting recvery. Osterman et al A small, single-center RCT cmparing discectmy with cnservative care was cmpleted in 2006.(11) A ttal f 56 patients referred t rthpedics fr sciatica were eligible fr inclusin, as defined by sciatica with pain radiating belw the knee, at least 1 specific physical exam sign cnsistent with sciatica, and radilgic cnfirmatin f a herniated disc. Patients in the surgical grup were treated with micrdiscectmy, and patients in the cnservative care grup were enrlled in a structured physitherapy prgram. The main utcme measure was intensity f leg pain measured n a 0 t 100 scale, and secndary utcmes were back pain, wrk ability, general quality f life, disability, depressin, and satisfactin with care. Fllw-up time pints were 6 weeks, 3 mnths, 1 year, and 2 years. 9

10 Medical Plicy All 28 patients in the surgery grup underwent surgery, and 11 f 28 (39%) patients in the cnservative care grup underwent surgery by the end f the study. Over the curse f the 2-year fllw-up, there were n verall differences n any f the primary utcmes between the surgical and cnservative care grups. At each time pint, the surgery grup had numerically superir results, but the differences did nt reach statistical significance. On subgrup analysis, there were significant imprvements fr the surgery grup n patients lder than 37 years, and n patients with L4-5 herniatin. Butterman et al An RCT cmparing discectmy with epidural sterid injectins was published by Butterman in 2004.(12) This trial enrlled 169 patients referred fr treatment f disc herniatin. All patients had a large disc herniatin, defined as greater than 25% the crsssectinal area f the spinal canal, at a single level. Patients with rapidly prgressive symptms and patients with recurrent disc herniatin were excluded. Cnservative care was administered fr the first 6 weeks f the trial, with imprvement in symptms fr 69 patients. The remaining 100 patients were randmized t discectmy r epidural spinal injectins. Fllw-up was fr 2 t 3 years, but there was a large decrease in the percent f patients available fr fllw-up after the 3-mnth time perid, particularly fr the injectin grup, in which nly apprximately half f the patients were available at any time pint lnger than 3 mnths. At 1- t 3-mnth fllw-up, pain scres, scres n the ODI, and medicatin use were lwer in the surgery grup cmpared with the injectin grup, but at later time pints there were n significant differences between grups. The percent f patients describing their treatment as successful ranged frm 92% t 98% at varius time pints fr patients in the surgery grup, cmpared with a range f 42% t 56% percent in the injectin grup. Systematic Reviews A systematic review based n a Cchrane Cllabratin review was published by Jacbs et al in 2011.(3) The authrs included 5 RCTs, 4 f which were the trials previusly discussed, with the additinal trial being the lder 1983 trial that was excluded frm this review. The authrs assigned a lw risk f bias t 2 f the 4 trials, the SPORT trial(9) and the Leiden-The Hague Spine Interventin Prgnstic Study.(10) The authrs determined that pling f the results was nt apprpriate due t differences in study methdlgy, and a qualitative synthesis f the data was perfrmed. The review cncluded that surgery was likely t lead t better shrt-term cntrl f leg pain, but that the verall quality f the bdy f evidence fr this utcme was lw. There were n differences demnstrated between surgery and cnservative care at time pints f 1 year r lnger. Lewis et al perfrmed a netwrk meta-analysis cmparing 21 different strategies fr treatment f sciatica.(13) This review included a ttal f 122 cmparative studies, 90 f which were RCTs. Fr disc surgery, there were 8 studies cmparing surgery with cnservative care (3 RCTs, 1 quasi-rct, 4 chrt studies), and 34 studies cmparing discectmy with ther alternative treatments, including ther surgical variatins. Fr the main utcme f verall recvery, surgery was better than exercise therapy, tractin, and percutaneus discectmy. Hwever, fr the utcme f pain, disc surgery was nt fund t be better than alternative treatments. Chu et al published a systematic review f the evidence fr efficacy f different surgical prcedures fr back pain, in cnjunctin with develpment f clinical guidelines by the American Pain Sciety.(14) Fr the questin f discectmy versus nnsurgical care, 4 studies were included, 3 f which were previusly reviewed. The studies were nt pled. The cnclusins f this evidence review were that discectmy, perfrmed either 10

11 Medical Plicy by pen surgery r micrdiscectmy, had superir utcmes f pain and disability at up t 3 mnths, but n definite benefit at lnger time pints. Nnrandmized Cmparative Studies The bservatinal chrt cmpnent f the SPORT trial enrlled patients wh met the eligibility criteria fr the SPORT RCT but wh declined randmizatin t treatment grup.(8) A ttal f 743 patients were enrlled, 528 underwent discectmy and 191 were treated with cnservative care. The primary utcmes (SF-36, ODI) and secndary utcmes (self-reprted imprvement, wrk status, satisfactin, symptm severity) were the same as fr the RCT, and fllw-up was accrding t same schedule f 3 mnths, 1 year, and 2 years. Fllw-up ranged between 82% and 89% fr different time pints. Study results reprted that the surgery grup had superir imprvements at 2 years n all primary and secndary utcme measures, except wrk status. The treatment effect as measured by the SF-36 Bdily Pain was 10.2 (95% CI, 5.9 t 14.5), the treatment effect f the SF-36 Physical Functin scale was 12.0 (95% CI, 7.9 t 16.1), and the treatment effect f the ODI was (95% CI, t -9.7). The Maine Lumbar Spine Study was a prspective chrt study that cmpared 10-year utcmes f discectmy with cnservative care.(15) There were 507 patients enrlled in the study, with 477 patients that survived until 10 years, and 10-year utcme data was available fr 400/477 (84%), 217 wh were treated surgically and 183 treated cnservatively. Apprximately 25% f patients wh were riginally treated with cnservative care underwent a surgical prcedure during the 10-year perid. Baseline data were btained frm a physician questinnaire, and utcme data were btained frm questinnaires mailed t patients. Patients treated with surgery had wrse symptms and decreased functinal status cmpared with patients treated cnservatively. At 10 years, there was n difference in the percent f patients wh reprted imprvement in their predminant symptm, n difference in the mdified Rland functinal status index, and n difference in wrk r disability status. There were significant differences in favr f surgery in the percent f patients wh reprted that their back r leg pain was cmpletely gne r much better (56% vs 40%, p=0.006), and n the percent f patients wh were satisfied with their care (71% vs 56%, p=0.002). Sectin Summary The cmparative evidence n lumbar discectmy versus cnservative care cnsists f a small number f RCTs and nnrandmized cmparative studies. The RCT evidence is limited by a lack f high-quality trials. In mst trials, there is a high percentage f patients in the cnservative grup wh crss ver t receive surgery. This high degree f cntaminatin leads t reduced pwer t detect a difference when an ITT analysis is used. Analysis by treatment received is als flawed because f the ptential nncmparability f grups resulting frm the high crssver. Despite the methdlgic limitatins f the evidence, the RCTs are cnsistent in demnstrating a prbable benefit fr surgery in mre rapid reslutin f pain and disability. Fr the ITT analyses, there are small differences in favr f surgery that, which smetimes reach statistical significance and ther times d nt. In cntrast, n analysis by treatment received and in the nnrandmized cmparative studies, there are larger differences in favr f surgery that exceed the threshld fr clinical significance. At time pints f 1 year r lnger, utcmes frm surgery and cnservative care appear t be equivalent. 11

12 Medical Plicy Cervical Discectmy There is cnsiderably less evidence available fr cervical discectmy cmpared with lumbar discectmy. Tw small RCTs were identified cmparing cervical discectmy with cnservative care. In 2013, Pelssn et al published an RCT f 63 patients frm 3 centers in Sweden randmized t structured exercise alne r structured exercise with cervical discectmy.(16) The surgical prcedure cnsisted f anterir cervical discectmy with fusin (ACDF). The primary utcmes were functinal measures, including range f mtin fr the neck, neck muscle endurance, and hand-related functins such as manual dexterity and grip strength. Fllw-up was at 3, 6, 12, and 24 mnths. During the study there were 2 crssvers frm the exercise grup t surgery. At 2-year fllw-up, there were n differences n any f the main utcmes. There were imprvements fr bth grups n multiple measures f functinal status, but n significant grup differences. This study did nt include any utcme measures f pain r disability. An earlier trial cmpared surgery with cnservative care in 81 patients with lngstanding cervical radiculpathy.(17) Patients were randmized t surgery r 1 f 2 cntrl grups, an active exercise prgram and use f a cervical cllar. Outcme measures included a VAS fr pain with a 0 t 100 range, muscle strength in the upper extremities, and sensatin in the upper extremities. Fllw-up time pints were 4 mnths and 12 mnths. Three patients in the surgery grup declined surgery because f imprvement in symptms, and there were n crssvers frm cnservative care t surgery. At the 4- mnth fllw-up, the surgery grup had less pain, less sensry lss, and better muscle strength. By 1 year, there were n grup differences n any f the main utcmes. A Cchrane cllabratin systematic review was published in 2010.(18) This review included the 2 RCTs previusly summarized, and identified n further trials fr inclusin. The authrs judged bth trials t have significant risk f bias and cncluded that there was lw-quality evidence fr a shrt-term benefit f surgery and n evidence fr a lngterm benefit. Hwever, they als stated that the risk/benefit rati f surgery is unclear and that is nt certain that the shrt-term benefits utweigh the risks. Sectin Summary There is cnsiderably less evidence n cervical discectmy cmpared with lumbar discectmy. Tw small trials with methdlgic limitatins were identified. These trials reprt results that are nt different frm the lumbar discectmy trials, but the trials are smaller and, as a result, have less pwer t detect a statistical difference. Althugh the evidence fr cervical discectmy is limited, it is likely that utcmes f lumbar discectmy can be extraplated t cervical discectmy, and it is unlikely that there are large differences in utcmes between lumbar and cervical discectmy. Onging and Unpublished Clinical Trials An nline search f ClinicalTrials.gv in July 2014 fund 1 nging trial fr discectmy. NCT is a randmized Canadian study cmparing surgery with standardized nnperative care fr the treatment f lumbar disc herniatins. The estimated enrllment fr this trial is 140 with an estimated cmpletin date f March Summary f Evidence The evidence n the efficacy f discectmy versus cnservative care cnsists f a small number f randmized cntrlled trials (RCTs) and nnrandmized, cmparative studies. Fr lumbar discectmy, 4 RCTs were identified, 2 f which were mderately large in size. There is less evidence fr cervical discectmy, and nly 2 small RCTs were identified fr 12

13 Medical Plicy this review. The RCT evidence is limited by a high rate f crssver frm the cnservative care t the surgery grup in nearly all trials. This rate f crssver was 40% r higher in sme trials, thereby greatly limiting the pwer t detect a difference when using an intentin-t-treat (ITT) analysis. Despite the methdlgic limitatins, the results frm these cmparative studies are fairly cnsistent. They reprt that n ITT analysis, the directin f shrt-term benefit favrs surgery fr almst all cmparisns, but the grup differences in many cases d nt reach statistical significance. Analysis by treatment received shws larger, clinically significant differences in utcmes favring surgery, and a similar magnitude f effect is reprted in nnrandmized, cmparative trials. Hwever, these analyses are limited by ptential nncmparability f treatment grups. The evidence is als cnsistent in reprting that the benefits are mainly shrt term, lasting fr weeks t mnths. At fllw-up time pints f 1 year r lnger, the best evidence reprts equivalent utcmes fr surgery and cnservative care. This supprts the cnclusin that surgery will result in mre rapid recvery f symptms and disability, but that there is n definite lng-term advantage t surgery. Based n the available evidence, it is pssible t cnclude that lumbar discectmy imprves symptms and disability in patients with herniated disc and radiculpathy wh are refractry t cnservative care. Therefre, the use f discectmy fr lumbar herniated disc may be cnsidered medically necessary when criteria are met. Fr cervical herniated disc, the evidence is less but nt substantially different frm lumbar herniated disc. Based n the available evidence and extraplatin frm studies f lumbar herniated disc, the use f discectmy fr cervical herniated disc may be cnsidered medically necessary when criteria are met. Practice Guidelines and Psitin Statements The Nrth American Spine Sciety issued 2012 evidence-based clinical guidelines n the diagnsis and treatment f lumbar disc herniatin with radiculpathy.(1) The guidelines state that discectmy is suggested t prvide mre effective symptm relief than medical/interventinal care fr patients with lumbar disc herniatin with radiculpathy whse symptms warrant surgical interventin. In patients with less severe symptms, surgery f medical/interventinal care appears t be effective fr bth shrt- and lngterm relief (grade B recmmendatin). There is als a grade C recmmendatin stating that endscpic percutaneus discectmy may be cnsidered fr the treatment f lumbar disc herniatin with radiculpathy. The Natinal Institute fr Health and Care Excellence issued a 2005 guidance (IPG141) n autmated percutaneus mechanical lumbar discectmy.(19) The guidance states that current evidence suggests that there are n majr safety cncerns assciated with autmated percutaneus mechanical lumbar discectmy; hwever, there is limited evidence f efficacy. Evidence frm small RCTs shws cnflicting results, and the prcedure shuld nt be perfrmed withut special arrangements fr cnsent and fr audit r research. U.S. Preventive Services Task Frce Recmmendatins Nt applicable. Medicare Natinal Cverage There is n natinal cverage determinatin (NCD). In the absence f an NCD, cverage decisins are left t the discretin f lcal Medicare carriers. 13

14 Medical Plicy References 1. Nrth American Spine Sciety. Clinical guideline: Diagnsis and treatment f lumbar herniated disc with radiculpathy. 2012; Herniatin.pdf. Accessed September 9, American Academy f Neurlgy (AAN). Use f epidural sterid injectins t treat lumbsacral radicular pain. 2007; Accessed 6/12/ Jacbs WC, van Tulder M, Arts M et al. Surgery versus cnservative management f sciatica due t a lumbar herniated disc: a systematic review. Eur Spine J. 2011; 20(4): Katayama Y, Matsuyama Y, Yshihara H et al. Cmparisn f surgical utcmes between macr discectmy and micr discectmy fr lumbar disc herniatin: a prspective randmized study with surgery perfrmed by the same spine surgen. J Spinal Disrd Tech. 2006; 19(5): Henriksen L, Schmidt K, Eskesen V et al. A cntrlled study f micrsurgical versus standard lumbar discectmy. Br J Neursurg. 1996; 10(3): Weber H. Lumbar disc herniatin. A cntrlled, prspective study with ten years f bservatin. Spine (Phila Pa 1976). 1983; 8(2): Erginusakis D, Filippiadis DK, Malagari A et al. Cmparative prspective randmized study cmparing cnservative treatment and percutaneus disk decmpressin fr treatment f intervertebral disk herniatin. Radilgy. 2011; 260(2): Weinstein JN, Lurie JD, Tstesn TD et al. Surgical vs nnperative treatment fr lumbar disk herniatin: the Spine Patient Outcmes Research Trial (SPORT) bservatinal chrt. JAMA. 2006; 296(20): Weinstein JN, Tstesn TD, Lurie JD et al. Surgical vs nnperative treatment fr lumbar disk herniatin: the Spine Patient Outcmes Research Trial (SPORT): a randmized trial. JAMA. 2006; 296(20): Peul WC, van Huwelingen HC, van den Hut WB et al. Surgery versus prlnged cnservative treatment fr sciatica. N Engl J Med. 2007; 356(22): Osterman H, Seitsal S, Karppinen J et al. Effectiveness f micrdiscectmy fr lumbar disc herniatin: a randmized cntrlled trial with 2 years f fllw-up. Spine (Phila Pa 1976). 2006; 31(21): Buttermann GR. Treatment f lumbar disc herniatin: epidural sterid injectin cmpared with discectmy. A prspective, randmized study. J Bne Jint Surg Am. 2004; 86-A(4): Lewis RA, Williams NH, Suttn AJ et al. Cmparative clinical effectiveness f management strategies fr sciatica: systematic review and netwrk metaanalyses. Spine J [Epub ahead f print] 14. Chu R, Baisden J, Carragee EJ et al. Surgery fr lw back pain: a review f the evidence fr an American Pain Sciety Clinical Practice Guideline. Spine (Phila Pa 1976). 2009; 34(10): Atlas SJ, Keller RB, Wu YA et al. Lng-term utcmes f surgical and nnsurgical management f sciatica secndary t a lumbar disc herniatin: 10 year results frm the maine lumbar spine study. Spine (Phila Pa 1976). 2005; 30(8): Pelssn A, Sderlund A, Engquist M et al. Physical functin utcme in cervical radiculpathy patients after physitherapy alne cmpared with anterir surgery fllwed by physitherapy: a prspective randmized study with a 2-year fllwup. Spine (Phila Pa 1976). 2013; 38(4):

15 Medical Plicy 17. Perssn LC, Mritz U, Brandt L et al. Cervical radiculpathy: pain, muscle weakness and sensry lss in patients with cervical radiculpathy treated with surgery, physitherapy r cervical cllar. A prspective, cntrlled study. Eur Spine J. 1997; 6(4): Niklaidis I, Fuyas IP, Sandercck PA et al. Surgery fr cervical radiculpathy r myelpathy. Cchrane Database Syst Rev. 2010(1):CD Natinal Institute fr Health and Clinical Excellence (NICE). IPG141 Autmated percutaneus mechanical lumbar discectmy. 2005; Accessed September 9, Blue Crss Blue Shield Assciatin. Medical Plicy Reference Manual, N (Octber 2014). Dcumentatin Required fr Clinical Review Histry and physical and/r cnsultatin ntes including: Clinical findings and duratin f pain Cmrbidities Activity and functinal limitatins Pertinent past prcedural and surgical histry Prir diagnstic testing and results Prir cnservative treatments, duratin, and respnse Psychlgical and psychscial assessment If significant cmrbidities, cnsultatin and medical clearance reprt(s) (if indicated) Other pertinent multidisciplinary ntes/reprts: (e.g., psychlgical r psychiatric evaluatin, physical therapy, multidisciplinary pain management) when applicable Radilgy reprt(s) and interpretatin (i.e., MRI, CT, discgram) Pst Service Operative reprt(s) Cding This Plicy relates nly t the services r supplies described herein. Benefits may vary accrding t benefit design; therefre, cntract language shuld be reviewed befre applying the terms f the Plicy. Inclusin r exclusin f a prcedure, diagnsis r device cde(s) des nt cnstitute r imply member cverage r prvider reimbursement. MN/IE The fllwing service/prcedure may be cnsidered medically necessary in certain instances and investigatinal in thers. Services may be medically necessary when plicy criteria are met. Services are cnsidered investigatinal when the plicy criteria 15

16 Medical Plicy are nt met r when the cde describes applicatin f a prduct in the psitin statement that is investigatinal. Type Cde Descriptin Lamintmy (hemilaminectmy), with decmpressin f nerve rt(s), including partial facetectmy, framintmy and/r excisin f herniated intervertebral disc; 1 interspace, cervical Lamintmy (hemilaminectmy), with decmpressin f nerve rt(s), including partial facetectmy, framintmy and/r excisin f herniated intervertebral disc; 1 interspace, lumbar Lamintmy (hemilaminectmy), with decmpressin f nerve rt(s), including partial facetectmy, framintmy and/r excisin f herniated intervertebral disc; each additinal interspace, cervical r lumbar (List separately in additin t cde fr primary prcedure) Lamintmy (hemilaminectmy), with decmpressin f nerve rt(s), including partial facetectmy, framintmy and/r excisin f herniated intervertebral disc, reexplratin, single interspace; cervical CPT Lamintmy (hemilaminectmy), with decmpressin f nerve rt(s), including partial facetectmy, framintmy and/r excisin f herniated intervertebral disc, reexplratin, single interspace; lumbar Lamintmy (hemilaminectmy), with decmpressin f nerve rt(s), including partial facetectmy, framintmy and/r excisin f herniated intervertebral disc, reexplratin, single interspace; each additinal cervical interspace (List separately in additin t cde fr primary prcedure) Lamintmy (hemilaminectmy), with decmpressin f nerve rt(s), including partial facetectmy, framintmy and/r excisin f herniated intervertebral disc, reexplratin, single interspace; each additinal lumbar interspace (List separately in additin t cde fr primary prcedure) Transpedicular apprach with decmpressin f spinal crd, equina and/r nerve rt(s) (e.g., herniated intervertebral disc), single segment; thracic Transpedicular apprach with decmpressin f spinal crd, equina and/r nerve rt(s) (e.g., herniated intervertebral disc), single segment; lumbar (including transfacet, r lateral extraframinal apprach) (e.g., far lateral herniated intervertebral disc) 16

17 Medical Plicy HCPC ICD-9 Prcedure ICD-10 Prcedure C2614 S2350 S2351 Transpedicular apprach with decmpressin f spinal crd, equina and/r nerve rt(s) (e.g., herniated intervertebral disc), single segment; each additinal segment, thracic r lumbar (List separately in additin t cde fr primary prcedure) Cstvertebral apprach with decmpressin f spinal crd r nerve rt(s) (e.g., herniated intervertebral disc), thracic; single segment Cstvertebral apprach with decmpressin f spinal crd r nerve rt(s) (e.g., herniated intervertebral disc), thracic; each additinal segment (List separately in additin t cde fr primary prcedure) Discectmy, anterir, with decmpressin f spinal crd and/r nerve rt(s), including stephytectmy; cervical, single interspace Discectmy, anterir, with decmpressin f spinal crd and/r nerve rt(s), including stephytectmy; cervical, each additinal interspace (List separately in additin t cde fr primary prcedure) Discectmy, anterir, with decmpressin f spinal crd and/r nerve rt(s), including stephytectmy; thracic, single interspace Discectmy, anterir, with decmpressin f spinal crd and/r nerve rt(s), including stephytectmy; thracic, each additinal interspace (List separately in additin t cde fr primary prcedure) Prbe, percutaneus lumbar discectmy Diskectmy, anterir, with decmpressin f spinal crd and/r nerve rt(s), including stephytectmy; lumbar, single interspace Diskectmy, anterir, with decmpressin f spinal crd and/r nerve rt(s), including stephytectmy; lumbar, each additinal interspace (list separately in additin t cde fr primary prcedure) Excisin f intervertebral disc Fr dates f service n r after 10/01/2015 0RB30ZZ Excisin f Cervical Vertebral Disc, Open Apprach 0RB33ZZ Excisin f Cervical Vertebral Disc, Percutaneus Apprach 0RB34ZZ Excisin f Cervical Vertebral Disc, Percutaneus Endscpic Apprach 0RBB0ZZ Excisin f Thraclumbar Vertebral Disc, Open Apprach 0RBB3ZZ Excisin f Thraclumbar Vertebral Disc, Percutaneus Apprach 17

18 Medical Plicy ICD-9 Diagnsis ICD-10 Diagnsis 0RBB4ZZ 0SB20ZZ 0SB23ZZ 0SB24ZZ 0SB40ZZ 0SB43ZZ 0SB44ZZ All Diagnses Fr dates f service n r after 10/01/2015 All Diagnses Excisin f Thraclumbar Vertebral Disc, Percutaneus Endscpic Apprach Excisin f Lumbar Vertebral Disc, Open Apprach Excisin f Lumbar Vertebral Disc, Percutaneus Apprach Excisin f Lumbar Vertebral Disc, Percutaneus Endscpic Apprach Excisin f Lumbsacral Disc, Open Apprach Excisin f Lumbsacral Disc, Percutaneus Apprach Excisin f Lumbsacral Disc, Percutaneus Endscpic Apprach Plicy Histry This sectin prvides a chrnlgical histry f the activities, updates and changes that have ccurred with this Medical Plicy. Effective Actin Date 2/27/2015 Plicy title change frm Laminectmy/Discectmy/Decmpressin BCBSA Medical Plicy adptin Plicy revisin with psitin change effective April 30, 2015 Reasn Medical Plicy Cmmittee Definitins f Decisin Determinatins Medically Necessary: A treatment, prcedure r drug is medically necessary nly when it has been established as safe and effective fr the particular symptms r diagnsis, is nt investigatinal r experimental, is nt being prvided primarily fr the cnvenience f the patient r the prvider, and is prvided at the mst apprpriate level t treat the cnditin. Investigatinal/Experimental: A treatment, prcedure r drug is investigatinal when it has nt been recgnized as safe and effective fr use in treating the particular cnditin in accrdance with generally accepted prfessinal medical standards. This includes services where apprval by the federal r state gvernmental is required prir t use, but has nt yet been granted. Split Evaluatin: Blue Shield f Califrnia / Blue Shield f Califrnia Life & Health Insurance Cmpany (Blue Shield) plicy review can result in a Split Evaluatin, where a treatment, prcedure r drug will be cnsidered t be investigatinal fr certain indicatins r cnditins, but will be deemed safe and effective fr ther indicatins r cnditins, and therefre ptentially medically necessary in thse instances. 18

19 Medical Plicy Prir Authrizatin Requirements This service (r prcedure) is cnsidered medically necessary in certain instances and investigatinal in thers (refer t plicy fr details). Fr instances when the indicatin is medically necessary, clinical evidence is required t determine medical necessity. Fr instances when the indicatin is investigatinal, yu may submit additinal infrmatin t the Prir Authrizatin Department. Within five days befre the actual date f service, the Prvider MUST cnfirm with Blue Shield that the member's health plan cverage is still in effect. Blue Shield reserves the right t revke an authrizatin prir t services being rendered based n cancellatin f the member's eligibility. Final determinatin f benefits will be made after review f the claim fr limitatins r exclusins. Questins regarding the applicability f this plicy shuld als be directed t the Prir Authrizatin Department. Please call r visit the Prvider Prtal The materials prvided t yu are guidelines used by this plan t authrize, mdify, r deny care fr persns with similar illness r cnditins. Specific care and treatment may vary depending n individual need and the benefits cvered under yur cntract. These Plicies are subject t change as new infrmatin becmes available. 19