Medical Review Criteria Implantable Neurostimulators

Transcription

1 Medical Review Criteria Implantable Neurstimulatrs Subject: Implantable Neurstimulatrs Backgrund: Implantable neurstimulatrs are micr-electrnic devices that deliver stimulatin t the nervus system and ffer varius therapeutic treatment ptins. Deep brain stimulatin (DBS) invlves cnstant, high-frequency electrical stimulatin f specific sites in the brain with implanted electrdes as a means t reduce the symptms f mvement disrders such as essential tremr and Parkinsn s disease. Gastric electrical stimulatin (GES) therapy is a treatment fr individuals with chrnic gastrparesis, a gastrintestinal mtility disrder characterized by delayed gastric emptying withut evidence f physical bstructin. The implanted stimulatr delivers electrical impulses t the gastric muscles t stimulate gastric myelectric activity, which imprves stmach emptying and reduces the frequency and severity f symptms. Sacral nerve stimulatin has been recently intrduced as an alternative, minimally invasive treatment ptin fr individuals with chrnic, severe fecal incntinence wh fail first-line cnservative therapies r wh are nt apprpriate candidates fr such therapies, and wh are cnsidering a mre invasive surgical ptin. Spinal crd stimulatin (SCS) invlves the electrical stimulatin f spinal nerves using electrdes implanted in the epidural space f the spinal clumn. The gal f SCS is t suppress pain in specific areas fr individuals with chrnic pain, including chrnic, refractry, neurpathic pain. Vagus nerve stimulatin (VNS) is a therapy fr treatment-resistant majr depressin and biplar disrder in which an implanted generatr, the neurcybernetic prsthesis, delivers electrical pulses t the cervical prtin f the vagus nerve. The gal f VNS is t reduce the severity and/r duratin f a depressive perid. Authrizatin: Prir authrizatin is required fr cvered implantable stimulatrs prvided t members enrlled in cmmercial (HMO, POS, and PPO) prducts. Plicy and Cverage Criteria: Harvard Pilgrim Health Care (HPHC) cnsiders implantable neurstimulatrs as reasnable and medically necessary with a request frm an accredited prvider with apprpriate state licensure and when dcumentatin cnfirms specific criteria fr ANY f the fllwing devices: Deep Brain Stimulatrs Unilateral r bilateral Deep Brain Stimulatrs are cnsidered reasnable and medically necessary when dcumentatin cnfirms member has ANY f the fllwing: Member age 7 years r lder requires treatment f intractable primary dystnia, including generalized and/r segmental dystnia, hemidystnia, and cervical dystnia (trticllis), OR Member has medically refractry essential tremrs, OR Member has medically intractable Parkinsn s disease including ALL the fllwing: Levdpa-respnsive; AND Mtr cmplicatins refractry t pharmaclgic therapy; AND Implantable Neurstimulatrs Page 1 f 8

2 Minimal scre f 30 pints n the mtr prtin f the Unified Parkinsn Disease Rating Scale when the individual has been withut medicatin fr apprximately 12 hurs Gastric Stimulatrs Gastric Stimulatrs are cnsidered reasnable and medically necessary when dcumentatin cnfirms member is experiencing severe gastrparesis f idipathic r diabetic rigin, and ALL the fllwing: Cnditin is refractry t prkinetic and antiemetic medicatins, r dcumentatin cnfirms that use f such medicatins is cntraindicated; AND Scintigraphy cnfirms delayed gastric emptying. Sacral Nerve Stimulatrs fr Urinary Incntinence Temprary trial f Sacral Nerve Stimulatrs is cnsidered reasnable and medically necessary when dcumentatin cnfirms member has urinary incntinence r frequency, and cnfirms ALL the fllwing: Psitive peripheral nerve evaluatin test fr urinary urge incntinence and urinary urgency/frequency; AND Diagnsis f urinary urgency with r withut incntinence, urinary urgency assciated with frequency and/r ncturia in the absence f infectin r ther pathlgy, OR nn-bstructive urinary retentin unrelated t a neurlgic cnditin; AND Dcumented failure f, r symptms refractry t, at least tw types f cnservative therapies, (e.g. behaviral interventins, dietary mdificatins, bladder training, trial f antichlinergic r beta agnist medicatins); AND Urinary incntinence is experienced fr a minimum f 12 mnths and is nt related t ther neurlgic cnditins that is assciated with secndary manifestatins f urinary urge incntinence, urgency, frequency r nn-bstructive urinary retentin. Permanent Sacral Nerve Stimulatrs are cnsidered reasnable and medically necessary when dcumentatin cnfirms member meets criteria fr temprary trial f sacral nerve stimulatrs fr urinary incntinence and has undergne a successful trial based n ALL the fllwing: Member has at least a 50% reductin in catheter vlume/catheterizatin; Member has at least 50% reductin in ONE f the fllwing: Daily incntinence episdes, OR Severity f the episdes r the number f pads/diapers used per day Member has at least 50% imprvement in ONE f the fllwing: Number f vids daily, OR Vlume per vid, OR Frequency per vid Sacral Nerve Stimulatrs fr Fecal Incntinence Temprary trial f Sacral Nerve Stimulatrs is cnsidered reasnable and medically necessary when dcumentatin cnfirms member has fecal incntinence, and cnfirms ALL the fllwing: Mre than 2 episdes f fecal incntinence per week fr 6 cnsecutive mnths, r fr 12 cnsecutive mnths fllwing vaginal childbirth; AND Incntinence is nt related t anther neurlgic cnditin (e.g. peripheral neurpathy, spinal crd injury) Dcumented failure f cnservative therapies fr at least 12 mnths, (e.g. medicatin, dietary mdificatin), r symptms r refractry t cnservative therapies. Implantable Neurstimulatrs Page 2 f 8

3 Permanent Sacral Nerve Stimulatrs are cnsidered reasnable and medically necessary when dcumentatin cnfirms member meets criteria fr temprary trial f sacral nerve stimulatrs fr fecal incntinence and has undergne a successful trial f at least 50% imprvement in symptms. Spinal Crd Stimulatrs Temprary trial f Spinal Crd Stimulatrs is cnsidered reasnable and medically necessary fr treatment f chrnic intractable pain secndary t cmplex reginal pain syndrme (CRPS) when dcumentatin cnfirms member has chrnic, intractable neurpathic pain f the trunk r limbs, and ALL the fllwing: Failure f at least 6 mnths f cnservative treatment (e.g., pharmactherapy, physical therapy, and/r surgery), r dcumentatin cnfirms cntraindicatins t cnservative treatment; AND Pain is neurpathic in nature (e.g. failed back surgery syndrme, cmplex reginal pain syndrme, phantm limb/stump pain and peripheral neurpathy) Permanent Spinal Crd Stimulatrs are cnsidered reasnable and medically necessary when dcumentatin cnfirms member meets criteria fr temprary trial f spinal crd stimulatrs and has undergne a successful trial f at least 50% imprvement in symptms. Vagal Nerve Stimulatr Vagal Nerve Stimulatrs are cnsidered reasnable and medically necessary when dcumentatin cnfirms ALL the fllwing: Member with refractry seizures experiences persistent seizures and/r intlerable side effects after trials f 2 r mre antiepileptic medicatins; AND Member has failed, r is nt a candidate fr, resective surgery Exclusins: Harvard Pilgrim Health Care (HPHC) cnsiders implantable neurstimulatrs as nt medically necessary fr all ther indicatins. In additin, HPHC des nt cver: Deep brain stimulatin fr cnditins including, but nt limited t: Chrnic cluster headache Degenerative disrders Depressin Drug-induced mvement disrder Infectius diseases Metablic disrders Multiple Sclersis (MS) Obsessive-Cmpulsive Disrder (OCD) Turette Syndrme Trauma Gastric stimulatin fr any ther indicatin, including besity Sacral nerve stimulatin fr cnditins including, but nt limited t: Anrectal malfrmatin; Chrnic inflammatry bwel disease; Chrnic pelvic pain; Cnstipatin; Fecal incntinence fllwing nn-cancer related rectal surgery within the past 12 mnths, r cancer-related rectal surgery within the past 24 mnths; Implantable Neurstimulatrs Page 3 f 8

4 Stress incntinence r ther chrnic viding dysfunctin due t neurlgic cnditins (e.g., spinal crd injury, diabetic neurpathy, MS Urge incntinence due t a neurlgic cnditin (e.g., detrusr hyperreflexia) Spinal nerve stimulatin fr cnditins including, but nt limited t: Refractry angina pectris Pain assciated with malignancy Treatment f critical limb ischemia Cancer-related pain Heart failure Vagus stimulatin fr cnditins including, but nt limited t: Addictins Alzheimer's disease Anxiety disrder Asthma Autism spectrum disrder Back and neck pain Biplar disrder Bulimia Cerebral palsy Crhn s Disease Chrnic pain syndrme Cluster headaches Depressin Essential tremr Fibrmyalgia Heart failure Migraines Mrbid besity Narclepsy Obsessive-cmpulsive disrder Paralysis agitans Sleep disrders Tinnitus Traumatic brain injury Turette's syndrme Cerebellar stimulatin/pacing fr any indicatin Occipital nerve stimulatin fr any indicatin Tibial nerve stimulatin fr any indicatin gammacre Peripheral nerve stimulatin Supprting Infrmatin: Accrding t a 2015 Cchrane Review, vagus nerve stimulatin (VNS) fr partial seizures appears t be an effective and well tlerated treatment. Results f the verall efficacy shwed that VNS stimulatin using high stimulatin paradigm was significantly better than lw stimulatin in reducing the frequency f seizures. Implantable Neurstimulatrs Page 4 f 8

5 The Academy f Neurlgy (AAN) published 2011 guidelines that recmmend deep brain stimulatin as a treatment ptin fr individuals with Parkinsn s Disease t reduce mtr fluctuatins, dyskinesia and medicatin usage. The Natinal Institute fr Health and Care Excellence (2017) recmmends ffering deep brain stimulatin fr individuals with advanced Parkinsn s disease whse symptms cannt be adequately cntrlled by best medical therapy. Guidelines: The Natinal Cverage Determinatin (NCD) fr Electrical Nerve Stimulatrs (160.7) indicates tw general classificatins f electrical nerve stimulatrs that are emplyed t treat chrnic intractable pain: peripheral nerve stimulatrs and central nervus system stimulatrs. Use f peripheral stimulatrs invlves implantatin f electrdes arund a selected peripheral nerve. The stimulating electrde is cnnected by an insulated lead t a receiver unit which is implanted under the skin at a depth nt greater than 1/2 inch. Stimulatin is induced by a generatr cnnected t an antenna unit which is attached t the skin surface ver the receiver unit. Implantatin f electrdes requires surgery and usually necessitates an perating rm. Peripheral nerve stimulatrs may als be emplyed t assess an individual s suitability fr cntinued treatment with an electric nerve stimulatr. There are tw types f implantatins cvered by central nervus system stimulatrs: drsal clumn (spinal crd) neurstimulatin and depth brain neurstimulatin. The implantatin f central nervus system stimulatrs may be cvered as therapies fr the relief f chrnic intractable pain, subject t the fllwing cnditins: The implantatin f the stimulatr is used nly as a late resrt (if nt a last resrt) fr individuals with chrnic intractable pain; With respect t item a, ther treatment mdalities (pharmaclgical, surgical, physical, r psychlgical therapies) have been tried and did nt prve satisfactry, r are judged t be unsuitable r cntraindicated fr the given individual; Individuals have undergne careful screening, evaluatin and diagnsis by a multidisciplinary team prir t implantatin. (Such screening must include psychlgical, as well as physical evaluatin); All the facilities, equipment, and prfessinal and supprt persnnel required fr the prper diagnsis, treatment training, and fllw up f the individual must be available; and Demnstratin f pain relief with a temprarily implanted electrde precedes permanent implantatin. The American Cllege f Gastrenterlgy (ACG, 2013) recmmends scintigraphic gastric emptying f slids as standard fr the evaluatin f gastric emptying and the diagnsis f gastrparesis. Dcumented delay in gastric emptying is required fr diagnsis f gastrparesis. Cding: Cdes are listed belw fr infrmatinal purpses nly, and d nt guarantee member cverage r prvider reimbursement. The list may nt be all-inclusive. Deleted cdes and cdes which are nt effective at the time the service is rendered may nt be eligible. CPT Cdes Descriptin Laparscpy, surgical; implantatin r replacement f gastric neurstimulatr electrdes, antrum Implantable Neurstimulatrs Page 5 f 8

6 43881 Implantatin r replacement f gastric neurstimulatr electrdes, antrum, pen Revisin r remval f gastric neurstimulatr electrdes, antrum, pen Twist drill r burr hle(s) fr implantatin f neurstimulatr electrdes, crtical Craniectmy r cranitmy fr implantatin f neurstimulatr electrdes, cerebral, crtical Twist drill, burr hle, cranitmy, r craniectmy with steretactic implantatin f neurstimulatr electrde array in subcrtical site (e.g., thalamus, glbus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), withut use f intraperative micrelectrde recrding; first array Twist drill, burr hle, cranitmy, r craniectmy with steretactic implantatin f neurstimulatr electrde array in subcrtical site (e.g., thalamus, glbus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), withut use f intraperative micrelectrde recrding; each additinal array (List separately in additin t primary prcedure) Twist drill, burr hle, cranitmy, r craniectmy with steretactic implantatin f neurstimulatr electrde array in subcrtical site (e.g., thalamus, glbus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), with use f intraperative micrelectrde recrding; first array Twist drill, burr hle, cranitmy, r craniectmy with steretactic implantatin f neurstimulatr electrde array in subcrtical site (e.g., thalamus, glbus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), with use f intraperative micrelectrde recrding; each additinal array (List separately in additin t primary prcedure) Craniectmy fr implantatin f neurstimulatr electrdes, cerebellar; crtical Revisin r remval f intracranial neurstimulatr electrdes Insertin r replacement f cranial neurstimulatr pulse generatr r receiver, direct r inductive cupling; with cnnectin t a single electrde array Insertin r replacement f cranial neurstimulatr pulse generatr r receiver, direct r inductive cupling; with cnnectin t 2 r mre electrde arrays Revisin r remval f cranial neurstimulatr pulse generatr r receiver Percutaneus implantatin f neurstimulatr electrde array, epidural Laminectmy fr implantatin f neurstimulatr electrdes, plate/paddle, epidural Insertin r replacement f spinal neurstimulatr pulse generatr r receiver, direct r inductive cupling Applicatin f surface (transcutaneus) neurstimulatr Percutaneus implantatin f neurstimulatr electrde array; cranial nerve Percutaneus implantatin f neurstimulatr electrde array; sacral nerve (transframinal placement) including image guidance, if perfrmed Incisin fr implantatin f neurstimulatr electrde array; sacral nerve (transframinal placement) Insertin r replacement f peripheral r gastric neurstimulatr pulse generatr r receiver, direct r inductive cupling Revisin r remval f peripheral r gastric neurstimulatr pulse generatr r receiver Electrnic analysis f implanted neurstimulatr pulse generatr system (e.g., rate, pulse amplitude, pulse duratin, cnfiguratin f wave frm, battery status, electrde selectability, utput mdulatin, cycling, impedance and patient cmpliance measurements); simple r Implantable Neurstimulatrs Page 6 f 8

7 cmplex brain, spinal crd, r peripheral (i.e., cranial nerve, peripheral nerve, sacral nerve, neurmuscular) neurstimulatr pulse generatr/transmitter, withut reprgramming Electrnic analysis f implanted neurstimulatr pulse generatr system (e.g., rate, pulse amplitude, pulse duratin, cnfiguratin f wave frm, battery status, electrde selectability, utput mdulatin, cycling, impedance and patient cmpliance measurements); simple spinal crd, r peripheral (i.e., peripheral nerve, sacral nerve, neurmuscular) neurstimulatr pulse generatr/transmitter, with intraperative r subsequent prgramming Electrnic analysis f implanted neurstimulatr pulse generatr system (e.g., rate, pulse amplitude, pulse duratin, cnfiguratin f wave frm, battery status, electrde selectability, utput mdulatin, cycling, impedance and patient cmpliance measurements); cmplex spinal crd, r peripheral (i.e., peripheral nerve, sacral nerve, neurmuscular) (except cranial nerve) neurstimulatr pulse generatr/transmitter, with intraperative r subsequent prgramming, first hur Billing Guidelines: Member s medical recrds must dcument that services are medically necessary fr the care prvided. Harvard Pilgrim Health Care maintains the right t audit the services prvided t ur members, regardless f the participatin status f the prvider. All dcumentatin must be available t HPHC upn request. Failure t prduce the requested infrmatin may result in denial r retractin f payment. References: 1. Abdi, S. Preventin and management f cmplex reginal pain syndrme in adults. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 2. Chrnic migraine. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 3. Deep Brain Stimulatin fr Parkinsn's Disease. Natinal Institute fr Health and Care Excellence (NICE); Available at: Accessed September 24, 4. Deep brain stimulatin fr treatment f bsessive-cmpulsive disrder. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 5. Deep Brain Stimulatin fr Treatment-Resistant Depressin. Hayesinc.cm/subscribers [via subscriptin nly]. Accessed July 31, 6. Depressin in adults: Overview f neurmdulatin prcedures. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 7. Evaluatin and management f drug-resistant epilepsy. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 8. Fecal incntinence in adults: Management. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 9. Grmley, EA., Lightner, DJ., Faraday, M., et al. Diagnsis and treatment f veractive bladder (nnneurgenic) in adults: AUA/SUFU guideline amendment. J Url. 2015; 193(5): Implantable Sacral Nerve Stimulatin fr Urinary Viding Dysfunctin. Hayesinc.cm/subscribers [via subscriptin nly]. Accessed July 31, 11. Management f Gastrparesis. Girg Available at: Accessed December 20, 12. Medical Technlgy Directry. Gastric electrical stimulatin fr gastrparesis. Hayesinc.cm/subscribers [via subscriptin nly]. Accessed July 31, Implantable Neurstimulatrs Page 7 f 8

8 13. Natinal Cverage Determinatin (NCD) fr Deep Brain Stimulatin fr Essential Tremr and Parkinsn s Disease (160.24) Natinal Cverage Determinatin (NCD) fr Sacral Nerve Stimulatin fr Urinary Incntinence (230.18) Natinal Cverage Determinatin (NCD) fr Vagus Nerve Stimulatin (VNS) ( ) Occipital Nerve Stimulatin fr Chrnic Cluster Headache and Chrnic Migraine. Hayesinc.cm/subscribers [via subscriptin nly]. Accessed July 31, 17. Overview f the treatment f chrnic pain. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 18. Panebianc M, Zavanne C, Dupnt S, Restiv D, Pavne A. Vagus nerve stimulatin therapy in partial epilepsy: a review. Acta Neurlgica Belgica. 2016;116(3): di: /s Spinal Crd Stimulatin fr Relief f Neurpathic Pain. Hayesinc.cm/subscribers [via subscriptin nly]. Accessed July 31, 20. Stewart, F., Gameir, OL., El Dib, R., et al. Electrical stimulatin with nn-implanted electrdes fr veractive bladder in adults. Cchrane Database Syst Rev. 2016; 4: CD Surgical treatment f essential tremr. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 22. Surgical treatment f Parkinsn disease. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 23. Treatment f dystnia. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 24. Treatment f urinary incntinence in wmen. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 25. Vagus Nerve Stimulatin fr Depressin. Hayesinc.cm/subscribers [via subscriptin nly]. Accessed July 31, 26. Vagus Nerve Stimulatin fr Epilepsy. Hayesinc.cm/subscribers [via subscriptin nly]. Accessed July 31, 27. Vagus nerve stimulatin therapy fr the treatment f epilepsy. UpTDate.cm/lgin [via subscriptin nly]. Accessed July 31, 28. Zesiewicz T, Elble R, Luis E et al. Evidence-based guideline update: Treatment f essential tremr: Reprt f the Quality Standards Subcmmittee f the American Academy f Neurlgy. Neurlgy. 2011;77(19): di: /wnl.0b013e318236f0fd. Summary f Changes Date Change 3/18 Backgrund and references updated; plicy cverage criteria refined 3/17 Updated cding t reflect deleted cde 8/16 Updated references. Minr frmatting changes. Apprved by Medical Plicy Review Cmmittee: 3/13/18 Revised: 2/15; 8/16; 3/17; 3/18 Initiated: 7/1/15 Implantable Neurstimulatrs Page 8 f 8