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Responsive Cortical Stimulation, Responsive cortical stimulation e g NeuroPace RNS System is proven and medically necessary for. treating Partial Onset Seizures when used according to U S Food and Drug Administration FDA labeled. indications contraindications warnings and precautions. Responsive cortical stimulation is unproven and not medically necessary for treating conditions in. individuals who do not meet the above criteria due to insufficient evidence of efficacy. DOCUMENTATION REQUIREMENTS, Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws. that may require coverage for a specific service The documentation requirements outlined below are used to assess. whether the member meets the clinical criteria for coverage but do not guarantee coverage of the service requested. CPT HCPCS Codes Required Clinical Information,Deep Brain and Cortical Stimulation. For stimulation used for idiopathic Parkinson s disease essential tremor and primary. 61863 dystonia medical notes documenting all of the following. 61864 Specify specific procedure e g thalamic VIM STN or GPI deep brain. 61867 stimulation,61868 Physician office notes that include. 61885 o Symptoms,61886 o Co morbidities, o Previous movement disorder surgery within the affected basal ganglion.
For Thalamic VIM include Fahn Tolosa Marin Clinical Tremor Rating Scale or. L8682 equivalent scale,L8685 For STN or GPI include. L8686 o Hoehn and Yahr stage or Unified Parkinson s Disease Rating Scale part III. L8687 motor subscale,L8688 o L dopa responsiveness. o Persistent disabling Parkinson symptoms despite optimal medical therapy. For code descriptions see the Applicable Codes section. DEFINITIONS, Generalized Seizures Seizures engaging networks across both cerebral hemispheres Epilepsy Foundation 2017. Partial Seizures Partial Onset Seizures or Focal Onset Seizures Seizures originating within networks limited. to one cerebral hemisphere Epilepsy Foundation 2017. Primary Dystonia A movement disorder in which dystonia is the only symptom and there is no known acquired. cause of the dystonia Primary Dystonia may occur for unknown reasons or may be inherited Phukan et al 2011. American Association of Neurological Surgeons 2018. Secondary Dystonia Secondary Dystonia occurs with illness after trauma or following exposure to certain. medications or toxins Phukan et al 2011, Secondary Parkinsonism Secondary Parkinsonism occurs as a result of head trauma metabolic conditions toxicity. drugs or other medical disorders,APPLICABLE CODES, The following list s of procedure and or diagnosis codes is provided for reference purposes only and may not be all.
inclusive Listing of a code in this policy does not imply that the service described by the code is a covered or non. covered health service Benefit coverage for health services is determined by the member specific benefit plan. document and applicable laws that may require coverage for a specific service The inclusion of a code does not imply. any right to reimbursement or guarantee claim payment Other Policies and Coverage Determination Guidelines may. CPT Code Description, 61850 Twist drill or burr hole s for implantation of neurostimulator electrodes cortical. Deep Brain and Cortical Stimulation Page 2 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019. Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. CPT Code Description, Craniectomy or craniotomy for implantation of neurostimulator electrodes cerebral. Twist drill burr hole craniotomy or craniectomy with stereotactic implantation of. neurostimulator electrode array in subcortical site e g thalamus globus pallidus. subthalamic nucleus periventricular periaqueductal gray without use of. intraoperative microelectrode recording first array. Twist drill burr hole craniotomy or craniectomy with stereotactic implantation of. neurostimulator electrode array in subcortical site e g thalamus globus pallidus. 61864 subthalamic nucleus periventricular periaqueductal gray without use of. intraoperative microelectrode recording each additional array List separately in. addition to primary procedure, Twist drill burr hole craniotomy or craniectomy with stereotactic implantation of. neurostimulator electrode array in subcortical site e g thalamus globus pallidus. subthalamic nucleus periventricular periaqueductal gray with use of intraoperative. microelectrode recording first array, Twist drill burr hole craniotomy or craniectomy with stereotactic implantation of.
neurostimulator electrode array in subcortical site e g thalamus globus pallidus. 61868 subthalamic nucleus periventricular periaqueductal gray with use of intraoperative. microelectrode recording each additional array List separately in addition to primary. Insertion or replacement of cranial neurostimulator pulse generator or receiver. direct or inductive coupling with connection to a single electrode array. Insertion or replacement of cranial neurostimulator pulse generator or receiver. direct or inductive coupling with connection to 2 or more electrode arrays. 64999 Unlisted procedure nervous system, CPT is a registered trademark of the American Medical Association. HCPCS Code Description, L8679 Implantable neurostimulator pulse generator any type. L8680 Implantable neurostimulator electrode each, L8682 Implantable neurostimulator radiofrequency receiver. Implantable neurostimulator pulse generator single array rechargeable includes. Implantable neurostimulator pulse generator single array nonrechargeable includes. Implantable neurostimulator pulse generator dual array rechargeable includes. Implantable neurostimulator pulse generator dual array nonrechargeable includes. DESCRIPTION OF SERVICES,Deep Brain Stimulation, Deep brain stimulation DBS delivers electrical pulses to select areas of the brain e g the internal globus pallidus. interna GPi subthalamic nucleus STN or ventral intermediate nucleus VIM of the thalamus via surgically. implanted electrodes The mechanism of action is not completely understood but the goal of DBS is to interrupt the. pathways responsible for the abnormal movements associated with movement disorders such as Parkinson s disease. and essential tremor The exact location of electrodes depends on the type of disorder being treated and unlike. standard surgical ablation which causes permanent destruction of the targeted area DBS is reversible and adjustable. The DBS device consists of an implantable pulse generator IPG or neurostimulator an implantable lead with. electrodes and a connecting wire The neurostimulator is approximately the size of a stop watch and is similar to a. cardiac pacemaker Subcutaneous extension wires connect the lead s to the neurostimulator which is implanted near. the clavicle or in the case of younger individuals with primary dystonia in the abdomen Conventional deep brain. stimulation systems deliver stimulation using cylindrical electrodes or Ring Mode omnidirectional stimulation which. stimulate neurons around the entire circumference of the lead Directional deep brain stimulation uses a directional. lead designed to steer electrical current to relevant areas of the brain while avoiding areas that may cause side effects. Deep Brain and Cortical Stimulation Page 3 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019.
Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. Several independent electrode contacts can be programmed creating a more customized therapy The St Jude. Medical InfinityTM DBS System is used for directional deep brain stimulation. When used according to U S Food and Drug Administration FDA indications deep brain stimulation is used to treat. selected individuals with Parkinson s disease essential tremor and primary dystonia Most forms of Parkinson s. disease are idiopathic having no specific known cause In secondary Parkinsonism the symptoms are a result of. head trauma metabolic conditions toxicity drugs or other medical disorders Primary dystonia occurs on its own. apart from any illness Secondary dystonia can occur with illness after trauma or following exposure to certain. medications or toxins Types of dystonia include,Generalized Affects multiple areas of the body. Focal Affects one specific area of the body such as the neck cervical dystonia or torticollis eyelid. blepharospasm or hand writer s cramp, Segmental Affects two or more adjacent parts of the body. Multifocal Affects two nonadjacent parts of the body. Hemidystonia Affects one side of the body,Cervical dystonia or torticollis. Responsive Cortical Stimulation Closed Loop Implantable Neurostimulator. The RNS System NeuroPace Inc is intended to detect abnormal electrical brain signals that precede seizures and. deliver electrical stimulation in response to try to normalize electrical brain activity and prevent seizures The device. includes a neurostimulator that is placed in the skull and leads that are placed in the seizure originating areas of the. brain The system s intended benefits include seizure prevention fewer adverse events than other neurostimulation. methods and data transmission from the individual s home to clinicians. BENEFIT CONSIDERATIONS, In certain benefit documents for example the 2001 Certificate of Coverage Humanitarian Use Devices HUDs. require Institutional Review Board IRB oversight and are considered to be investigational and not covered In other. benefit documents for example the 2007 Certificate of Coverage and subsequent versions HUDs are not considered. to be investigational and are covered when used for proven indications Please consult the member specific benefit. plan document for details,CLINICAL EVIDENCE,Deep Brain Stimulation.
Parkinson s Disease and Essential Tremor, Evidence from available published studies indicates that deep brain stimulation DBS provides clinically and. statistically significant improvements in patients with Parkinson s disease PD and essential tremor ET. In a meta analysis Peng et al 2018 assessed the long term efficacy of deep brain stimulation DBS of the. subthalamic nucleus STN and globus pallidus interna GPi for Parkinson disease PD A total of 5 studies with 890. subjects 437 patients in the STN DBS group and 453 patients in the GPi DBS group were included in the analysis. The study results showed no significant differences between STN DBS and GPi DBS in the long term efficacy of unified. Parkinson disease rating scale section UPDRS III scores including motor subtypes The authors concluded that STN. DBS and GPi DBS improve motor function and activities of daily living for PD. Roper et al 2016 conducted a systematic review and meta analysis on gait speed in patients with PD to summarize. the effectiveness of DBS A random effects model meta analysis on 27 studies revealed a significant overall. standardized mean difference medium effect size equal to 0 60 Based on the synthesis of the 27 studies the authors. determined the following 1 a significant and medium effect size indicating DBS improves gait speed 2 DBS. improved gait speed regardless of whether the patients were tested in the on or off medication state and 3 both. bilateral and unilateral DBS led to gait speed improvement According to the authors the current analysis provides. objective evidence that both unilateral and bilateral DBS provide a therapeutic benefit on gait speed in persons with. Tan et al 2016 conducted a systematic review and meta analysis to compare DBS stimulation of globus pallidus. internus GPi and subthalamic nucleus STN which are the most targeted locations for the procedure Clinical. outcomes of motor function non motor function and quality of life QOL were collected for the meta analysis Ten. eligible trials with 1 034 patients were included in the analysis Unified Parkinson s disease rating scale III UPDRS III. scores were collected at 6 12 and 24 months postsurgery separately to assess the motor function of the patients A. statistically significant effect in favor of the GPi DBS was obtained in the off medication on stimulation phase of. UPDRS III at 12 months However GPi DBS showed an opposite result at 24 months In the on medication on. stimulation phase GPi DBS obtained a worse outcome compared with STN DBS Compared with STN DBS increased. Deep Brain and Cortical Stimulation Page 4 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019. Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. dosage of levodopa equivalent doses was needed in GPi DBS Meanwhile Beck Depression Inventory II scores. demonstrated that STN has a better performance As for neurocognitive phase postsurgery GPi DBS showed better. performance in three of the nine tests especially in verbal fluency Use of GPi DBS was associated with a greater. effect in eight of the nine subscales of QOL The authors concluded that GPi and STN DBS significantly improve. advanced Parkinson s patients symptoms functionality and QOL According to the authors the question regarding. which target is superior remains open for discussion An understanding of the target selection depends on individual. symptoms neurocognitive mood status therapeutic goals of DBS e g levodopa reduction and surgical expertise. In a meta analysis of randomized controlled trials RCTs Perestelo Perez et al 2014 described the efficacy of DBS. in improving motor signs functionality and quality of life of PD patients Six RCTs n 1 184 that compared DBS plus. medication versus medication alone were included in the analysis The results showed that DBS significantly improves. patients symptoms functionality and quality of life Effects sizes are intense for the reduction of motor signs and. improvement of functionality in the off medication phase in addition to the reduction of the required medication dose. and its associated complications Moderate effects were observed in the case of motor signs and time in good. functionality in the on medication phase in addition to the quality of life Although the number of RCTs obtained is. small the total sample size is relatively large confirming the efficacy of DBS in the control of motor signs and. improvement of patients functionality and quality of life. To assess the current state of knowledge on essential tremor ET therapy and make recommendations based on the. analysis of evidence Zappia et al 2013 reviewed the literature regarding pharmacologic and surgical therapies. providing a quality assessment of the studies and the strength of recommendations for each treatment A systematic. literature review was performed to identify all the studies conducted on patients with ET Based on the results of the. review thalamic deep brain stimulation was recommended for refractory ET. In a National Institute for Health and Care Excellence NICE Guidance for Parkinson s disease in adults NICE states. that deep brain stimulation should be considered for individuals with advanced Parkinson s disease whose symptoms. are not adequately controlled by best medical therapy NICE 2017. Professional Societies,American Academy of Neurology AAN. The AAN issued an update of the 2005 American Academy of Neurology practice parameter on the treatment of. essential tremor ET in 2011 Zesiewicz et al The following conclusions and recommendations for deep brain. stimulation were unchanged from the 2005 practice parameter. DBS of the VIM thalamic nucleus may be used to treat medically refractory limb tremor in essential tremor Level. C possibly effective ineffective or harmful for the given condition in the specified population. There is insufficient evidence to make recommendations regarding the use of thalamic DBS for head or voice. tremor Level U data inadequate or conflicting given current knowledge treatment is unproven. DBS has fewer adverse events than thalamotomy Level B probably effective ineffective or harmful for the. given condition in the specified population However the decision to use either procedure depends on each. patients circumstances and risk for intraoperative complications compared to feasibility of stimulator monitoring. and adjustments, The updated 2011 practice parameter indicated that there were no additional trials published between 2004 and April. 2010 rated better than Class IV that examined the efficacy and safety of deep brain stimulation DBS of the. thalamus for the treatment of ET, Moro et al 2017 conducted a systematic review and meta analysis to evaluate the clinical evidence of the efficacy of.
deep brain stimulation DBS of the globus pallidus internus GPi in isolated inherited or idiopathic dystonia In total. 24 studies were included in the meta analysis comprising 523 patients The mean absolute and percentage. improvements in Burke Fahn Marsden Dystonia Rating Scale BFMDRS motor score at the last follow up mean 32 5. months 24 studies were 26 6 points and 65 2 respectively The corresponding changes in disability score at the. last follow up mean 32 9 months 14 studies were 6 4 points and 58 6 Multivariate meta regression of absolute. scores indicated that higher BFMDRS motor and disability scores before surgery together with younger age at time of. surgery were the main factors associated with significantly better DBS outcomes at the latest follow up Reporting of. safety data was frequently inconsistent and could not be included in the meta analysist The authors concluded that. patients with isolated inherited or idiopathic dystonia significantly improved after GPi DBS Better outcomes were. associated with greater dystonia severity at baseline According to the authors these findings should be taken into. consideration for improving patient selection for DBS. Andrews et al 2010 analyzed combined published results of individual patient outcomes following DBS for all types. of dystonia Data was available in 157 studies for 466 patients with all forms of dystonia The subclassification of. these patients included 344 with primary forms of dystonia 10 with myoclonus dystonia 19 with heredodegenerative. Deep Brain and Cortical Stimulation Page 5 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019. Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. dystonias and 93 who had DBS for secondary dystonia Patients with primary forms of dystonia myoclonus dystonia. subtypes of heredodegenerative dystonia and tardive dystonia have a greater than 50 mean improvement in. dystonia severity following DBS Among patients with primary generalized dystonia multiple regression analysis. showed that a shorter duration of symptoms a lower baseline severity score and DYT1 positive status were all. independently associated with a significantly higher percentage improvement from surgery Patients with other forms. of heredodegenerative and secondary dystonia have variable responses making prediction of response in future. patients difficult, Koy et al 2013 performed a meta analysis and analyzed the published literature regarding deep brain stimulation. and secondary dystonia to evaluate the effect on cerebral palsy a common cause of secondary dystonia Twenty. articles that included 68 patients with cerebral palsy undergoing deep brain stimulation assessed by the Burke Fahn. Marsden Dystonia Rating Scale were identified Most articles were case reports reflecting great variability in the score. and duration of follow up The mean Burke Fahn Marsden Dystonia Rating Scale movement score was 64 94 25 40. preoperatively and dropped to 50 5 26 77 postoperatively with a mean improvement of 23 6 at a median follow. up of 12 months There was a significant negative correlation between severity of dystonia and clinical outcome The. authors concluded that deep brain stimulation can be an effective treatment option for dyskinetic cerebral palsy The. authors stated that in view of the heterogeneous data a prospective study with a large cohort of patients in a. standardized setting with a multidisciplinary approach would be helpful in further evaluating the role of deep brain. stimulation in cerebral palsy, In a systematic review Macerollo and Deuschl 2018 analyzed the currently available literature reporting cases with. either tardive dystonia a form of secondary dystonia or tardive dyskinesia treated with DBS Thirty four level VI. studies and one level II study with 117 patients were included Level I studies were not identified Only four of the. patients had tardive dyskinesia All the others had tardive dystonia The majority had globus pallidus internum Gpi. DBS n 109 Patients had a mean age of 47 4 SD 14 7 years The duration of follow up was 25 6 months. 26 2 The Abnormal Involuntary Movement Scale was reported in 51 patients with an improvement of 62 15 and. the Burke Fahn Marsden scale was reported in 67 cases with an improvement of 76 21 Reported adverse events. were surgery related in 7 patients stimulation induced in 12 and psychiatric in 3 patients These reports suggest. favorable effects of DBS and it seems to be relatively safe The authors indicated that DBS is still a last resort for. tardive syndrome TS and stimulation parameters and implanted targets are empirical based on the benefit observed. in other more widely explored diseases such as essential tremor and dyskinesia in PD According to the authors the. limited available data and the lack of a prospective controlled trial prevent them from making final conclusions and. recommendations, The National Institute for Health and Care Excellence NICE issued a guidance stating that the current evidence. supports the safety and efficacy of DBS as a treatment modality for dystonia Dystonia may be treated conservatively. or surgically Conservative treatment only treats the symptoms and surgical intervention i e thalamotomy and. pallidotomy may not render long term benefits Patient selection and management should be managed by a. multidisciplinary team specializing in the long term care of patients with movement disorders NICE 2006. Tourette Syndrome, Servello et al 2016 performed a systematic review of the published studies on deep brain stimulation DBS for.
Tourette s syndrome TS The majority of studies were case reports or small series The thalamus and the globus. pallidus internus appear to be the most promising targets However in light of the great methodological diversity a. balanced comparison of clinical outcome and understanding of the role of DBS in TS remains problematic The authors. concluded that despite 16 years of experience with DBS in TS a consensus on many issues foremost on target. selection and the age of inclusion continue to be missing According to the authors class I evidence with larger. patient populations are urgently needed in order to evaluate the role of DBS in TS. Baldermann et al 2016 conducted a systematic literature review to evaluate the efficacy of beep brain stimulation. DBS for severe cases of Tourette syndrome that failed to respond to standard therapies In total 57 studies were. eligible including 156 cases Overall DBS resulted in a significant improvement of 52 68 in the Yale Global Tic. Severity Scale YGTSS Analysis of controlled studies significantly favored stimulation versus off stimulation with a. standardized mean difference of 0 96 Disentangling different target points revealed significant YGTSS reductions after. stimulation of the thalamus the posteroventrolateral part and the anteromedial part of the globus pallidus internus. the anterior limb of the internal capsule and nucleus accumbens with no significant difference between these targets. A significant negative correlation of preoperative tic scores with the outcome of thalamic stimulation was found. Despite small patient numbers the authors conclude that DBS for GTS is a valid option for medically intractable. patients Different brain targets resulted in comparable improvement rates indicating a modulation of a common. network According to the authors the results of this pooled meta analysis are encouraging but it should be noted. that these results are mainly based on studies that must be classified as evidence level IV according to the. classification of the American Academy of Neurology The authors stated that the efficacy and the individual side effect. profile of DBS must be further tested by double blinded randomized controlled trials with larger sample sizes. Deep Brain and Cortical Stimulation Page 6 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019. Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. In a randomized double blind controlled trial Welter et al 2017 assessed the efficacy of anterior internal globus. pallidus aGPi DBS for severe Tourette s syndrome The study included patients aged 18 60 years with severe and. medically refractory Tourette s syndrome from eight hospitals specialized in movement disorders Enrolled patients. received surgery to implant bilateral electrodes for aGPi DBS 3 months later they were randomly assigned 1 1 ratio. with a block size of eight computer generated pairwise randomization according to order of enrolment to receive. either active or sham stimulation for the subsequent 3 months in a double blind fashion All patients then received. open label active stimulation for the subsequent 6 months Patients and clinicians assessing outcomes were masked. to treatment allocation an unmasked clinician was responsible for stimulation parameter programming with intensity. set below the side effect threshold Nineteen patients were enrolled in the trial The investigators randomly assigned. 17 89 patients with 16 completing blinded assessments seven 44 in the active stimulation group and nine. 56 in the sham stimulation group There was no significant difference in YGTSS score change between the. beginning and the end of the 3 month double blind period between groups During the following 6 month open label. period stimulation decreased motor and vocal tic severity with evidence of an improvement in occupational activities. and life satisfaction Fifteen serious adverse events were reported in 13 patients of which eight events were related to. the surgical procedure or hardware According to the authors future research is needed to investigate the efficacy of. aGPi DBS for patients over longer periods with optimal stimulation parameters and to identify potential predictors of. the therapeutic response, In a randomized double blind crossover trial Kefalopoulou et al 2015 recruited eligible patients severe medically. refractory Tourette s syndrome age 20 years from two clinics for tertiary movement disorders Enrolled patients. received surgery for globus pallidus internus GPi DBS and then were randomly assigned in a 1 1 ratio computer. generated pairwise randomization according to order of enrollment to receive either stimulation on first or. stimulation off first for 3 months followed by a switch to the opposite condition for a further 3 month period Patients. and rating clinicians were masked to treatment allocation an unmasked clinician was responsible for programming. the stimulation Fifteen patients were enrolled in the study Fourteen patients were randomly assigned and 13. completed assessments in both blinded periods seven in the on first group six in the off first group Mean Yale. Global Tic Severity Scale YGTSS total score in these 13 patients was 87 9 at baseline 80 7 for the off stimulation. period and 68 3 for the on stimulation period All 15 patients received stimulation in the open label phase Overall. three serious adverse events occurred two infections in DBS hardware at 2 and 7 weeks postoperatively and one. episode of deep brain stimulation induced hypomania during the blinded on stimulation period all three resolved. with treatment The authors concluded that GPi stimulation led to a significant improvement in tic severity with an. overall acceptable safety profile According to the authors future research should concentrate on identifying the most. effective target for DBS to control both tics and associated comorbidities and further clarify factors that predict. individual patient response, Martinez Ramirez et al 2018 assessed the efficacy and safety of deep brain stimulation DBS in a multinational. cohort of patients with Tourette syndrome using the International Deep Brain Stimulation Database and Registry The. registry included 185 patients with medically refractory Tourette syndrome who underwent DBS implantation from. January 1 2012 to December 31 2016 at 31 institutions in 10 countries worldwide These patients received DBS. implantation in different regions of the brain depending on their symptoms The mean SD total Yale Global Tic. Severity Scale score improved from 75 01 18 36 at baseline to 41 19 20 00 at 1 year after DBS implantation The. mean SD motor tic subscore improved from 21 00 3 72 at baseline to 12 91 5 78 after 1 year and the mean SD. phonic tic subscore improved from 16 82 6 56 at baseline to 9 63 6 99 at 1 year The overall adverse event rate. was 35 4 56 of 158 patients The most common stimulation induced adverse effects were dysarthria 10 6 3. and paresthesia 13 8 2 The authors concluded that deep brain stimulation was associated with symptomatic. improvement in patients with Tourette syndrome but also with important adverse events Long term assessments will. be necessary to monitor adverse effects and determine if DBS has lasting effects on symptoms. A European guideline on DBS was developed by a working group of the European Society for the Study of Tourette. Syndrome ESSTS A systematic literature search was conducted and expert opinions of the guidelines group. contributed also to the recommendations Of 63 patients reported so far in the literature 59 had a beneficial outcome. following DBS with moderate to marked tic improvement However randomized controlled studies including a larger. number of patients are still lacking Although persistent serious adverse effects AEs have hardly been reported. surgery related e g bleeding infection as well as stimulation related AEs e g sedation anxiety altered mood. changes in sexual function may occur According to the ESSTS working group at the present time DBS in TS is still. in its infancy Due to both different legality and practical facilities in different European countries these guidelines. therefore need to be understood as recommendations of experts However among the ESSTS working group on DBS. in TS there is general agreement that at present time DBS should only be used in adult treatment resistant and. severely affected patients It is highly recommended to perform DBS in the context of controlled trials M ller Vahl et. Deep Brain and Cortical Stimulation Page 7 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019. Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. The First World Congress on Tourette Syndrome and Tic Disorders was held in June of 2016 in London by the Tourette. Association of America Tourette s Action UK and the European Society for the Study of Tourette Syndrome Topics. included the use of depth and cortical surface electrodes to investigate the neurophysiology of tics on the background. of the evolving field of deep brain stimulation DBS The authors indicated that in addition to the conventional. treatments of pharmacotherapy and behavioral therapy alternative approaches are also evolving ranging from. neurosurgical stereotactic DBS which has a limited evidence base Mathews and Stern 2016. Depression, Kisely et al 2018 performed a systematic review and meta analysis on the effectiveness of deep brain stimulation.
DBS in depression Cochrane Central Register of Controlled Trials PubMed Medline Embase and PsycINFO Chinese. Biomedical Literature Service System and China Knowledge Resource Integrated Database were searched for single. or double placebo controlled crossover and parallel group trials in which DBS was compared with sham treatment. using validated scales Ten papers from nine studies met inclusion criteria all but two of which were double blinded. RCTs The main outcome was a reduction in depressive symptoms It was possible to combine data for 190. participants Patients on active as opposed to sham treatment had a significantly higher response and reductions in. mean depression score However the effect was attenuated on some of the subgroup and sensitivity analyses and. there were no differences for most other outcomes In addition 84 participants experienced a total of 131 serious. adverse effects although not all could be directly associated with the device or surgery Finally publication bias was. possible The authors concluded that DBS may show promise for treatment resistant depression but remains an. experimental treatment until further data are available. McGirr and Berlim 2018 conducted a meta review of meta analyses published in the past decade on therapeutic. neuromodulation i e repetitive transcranial magnetic stimulation transcranial direct current stimulation vagus. nerve stimulation and deep brain stimulation for major depression According to the authors vagus nerve stimulation. and deep brain stimulation although more challenging to investigate have demonstrated preliminary effectiveness. particularly during longer term follow up, In a systematic review Naesstr m et al 2016 reviewed the current studies on psychiatric indications for deep brain. stimulation DBS with focus on obsessive compulsive disorder OCD and major depressive disorder MDD A total. of 52 studies met the inclusion criteria with a total of 286 unique patients treated with DBS for psychiatric indications. 18 studies described 112 patients treated with DBS for OCD in six different anatomical targets while nine studies. included 100 patients with DBS for MDD in five different targets The authors concluded that DBS may show promise. for treatment resistant OCD and MDD but the results are limited by small sample size and insufficient randomized. controlled data According to the authors other psychiatric indications are currently of a purely experimental nature. Berlim et al 2014 conducted a systematic review and exploratory meta analysis to investigate deep brain. stimulation DBS applied to the subgenual cingulate cortex SCC as a potential treatment for severe and chronic. treatment resistant depression TRD Data from 4 observational studies were included in the analysis totaling 66. subjects with severe and chronic TRD Twelve month response and remission rates following DBS treatment were. 39 9 and 26 3 respectively Also depression scores at 12 months post DBS were significantly reduced There was. a significant decrease in depression scores between 3 and 6 months but no significant changes from months 6 to 12. Finally dropout rates at 12 months were 10 8 The authors concluded that DBS applied to the SCC seems to be. associated with relatively large response and remission rates in the short and medium to long term in patients with. severe TRD Also its maximal antidepressant effects are mostly observed within the first 6 months after device. implantation According to the authors these findings are clearly preliminary and future controlled trials should. include larger and more representative samples and focus on the identification of optimal neuroanatomical sites and. stimulation parameters, Morishita et al 2014 performed a systematic review of the literature pertaining to DBS for treatment resistant. depression to evaluate the safety and efficacy of this procedure The reviewers identified 22 clinical research papers. with 5 unique DBS approaches using different targets including nucleus accumbens ventral striatum ventral capsule. subgenual cingulate cortex lateral habenula inferior thalamic nucleus and medial forebrain bundle Among the 22. published studies only 3 were controlled trials and 2 as yet unpublished multicenter randomized controlled trials. evaluating the efficacy of subgenual cingulate cortex and ventral striatum ventral capsule DBS were recently. discontinued owing to inefficacy based on futility analyses Overall the published response rate to DBS therapy. defined as the percentage of patients with 50 improvement on the Hamilton Depression Rating Scale is reported. to be 40 70 and outcomes were comparable across studies The authors concluded that DBS for MDD shows. promise but remains experimental and further accumulation of data is warranted. A Comparative Effectiveness Review was prepared for the Agency for Healthcare Research and Quality AHRQ on. Nonpharmacologic Interventions for Treatment Resistant Depression in Adults The report indicated that clinical trial. data on some of the developing nonpharmacologic interventions such as deep brain stimulation were insufficient. from the published literature to include them in the report The authors stated that as the evidence bases grow to. Deep Brain and Cortical Stimulation Page 8 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019. Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. support the efficacy of such nonpharmacologic interventions the newer strategies should be included in comparative. effectiveness study designs Gaynes et al 2011,Professional Societies. American Psychiatric Association APA, In a clinical practice guideline for the treatment of patients with major depressive disorder the APA states that.
electroconvulsive therapy remains the treatment of best established efficacy against which other stimulation. treatments e g VNS deep brain stimulation transcranial magnetic stimulation other electromagnetic stimulation. therapies should be compared The APA did not assign a rating for the use deep brain stimulation in treating. depression Gelenberg et al 2010, In a meta analysis and systematic review Chang and Xu identified possible predictors of remarkable seizure reduction. RSR for deep brain stimulation DBS in patients with refractory temporal lobe epilepsy TLE The authors. conducted a comprehensive search of English language literature published since 1990 that addressed seizure. outcomes in patients who underwent DBS for refractory TLE A pooled RSR rate was determined for eight included. studies RSR rates were analyzed relative to potential prognostic variables Random or fixed effects models were. used depending on the presence or absence of heterogeneity The pooled RSR rate among 61 DBS treated patients. with TLE from 8 studies was 59 Higher likelihood of RSR was found to be associated with lateralization of. stimulation lateralized ictal EEG findings and a longer follow up period Seizure semiology MRI abnormalities and. patient sex were not predictive of RSR rate Hippocampal and anterior thalamic nuclei ATN sites of stimulation had. similar odds of producing RSR The authors concluded that DBS is an effective therapeutic modality for intractable TLE. particularly in patients with lateralized EEG abnormalities and in patients treated on the ictal side Studies with higher. levels of evidence and larger populations are needed to determine if DBS is effective for treating epilepsy. Zhou et al 2018 evaluated the studies published on the topic of open loop DBS for epilepsy over the past decade. 2008 to present Among the 41 articles included in the analysis 19 reported on stimulation of the anterior nucleus. of the thalamus 6 evaluated stimulation of the centromedian nucleus of the thalamus and 9 evaluated stimulation of. the hippocampus The remaining 7 articles reported on the evaluation of alternative DBS targets The authors. evaluated each study for overall epilepsy response rates as well as adverse events and other significant non epilepsy. outcomes According to the authors one level I trial the SANTE trial supported the safety and efficacy of stimulating. the anterior nucleus of the thalamus and the hippocampus for the treatment of medically refractory epilepsy Level III. and IV evidence supports stimulation of other targets for epilepsy Ongoing research into the efficacy adverse effects. and mechanisms of open loop DBS is required, Sprengers et al 2017 assessed the efficacy safety and tolerability of DBS and cortical stimulation for refractory. epilepsy based on randomized controlled trials RCTs The RCTs selected for the review compared deep brain or. cortical stimulation versus sham stimulation resective surgery further treatment with antiepileptic drugs or other. neurostimulation treatments including vagus nerve stimulation Twelve RCTs were identified eleven of these. compared one to three months of intracranial neurostimulation with sham stimulation The authors concluded that. except for one very small RCT only short term RCTs on intracranial neurostimulation for epilepsy are available. Compared to sham stimulation one to three months of anterior thalamic DBS multi focal epilepsy responsive ictal. onset zone stimulation multi focal epilepsy and hippocampal DBS temporal lobe epilepsy moderately reduce. seizure frequency in refractory epilepsy patients Anterior thalamic DBS is associated with higher rates of self reported. depression and subjective memory impairment According to the authors there is insufficient evidence to make firm. conclusive statements on the efficacy and safety of hippocampal DBS centromedian thalamic DBS nucleus. accumbens DBS and cerebellar stimulation There is a need for more large and well designed RCTs to validate and. optimize the efficacy and safety of invasive intracranial neurostimulation treatments. In a National Institute for Health and Care Excellence NICE Guidance for deep brain stimulation for refractory. epilepsy NICE stated that the evidence on the efficacy of deep brain stimulation for refractory epilepsy is limited in. both quantity and quality NICE recommends that this procedure should only be used with special arrangements for. clinical governance consent and audit or research NICE 2012. Obsessive Compulsive Disorder OCD, In a systematic review V zquez Bourgon et al 2017 evaluated the current scientific evidence on the effectiveness. and applicability of deep brain stimulation for refractory obsessive compulsive disorder OCD The critical analysis of. the evidence shows that the use of DBS in treatment resistant OCD is providing satisfactory results regarding efficacy. with assumable side effects However there is insufficient evidence to support the use of any single brain target over. another The authors concluded that the use of DBS for OCD is still considered to be in the field of research although. it is increasingly used in refractory OCD producing in the majority of studies significant improvements in. symptomatology and in functionality and quality of life According to the authors it is important to implement. random and controlled studies regarding its long term efficacy cost risk analyses and cost benefit. Deep Brain and Cortical Stimulation Page 9 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019. Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. In a systematic review Naesstr m et al 2016 reviewed the current studies on psychiatric indications for deep brain. stimulation DBS with focus on obsessive compulsive disorder OCD and major depressive disorder MDD A total. of 52 studies met the inclusion criteria with a total of 286 unique patients treated with DBS for psychiatric indications. 18 studies described 112 patients treated with DBS for OCD in six different anatomical targets while nine studies. included 100 patients with DBS for MDD in five different targets The authors concluded that DBS may show promise. for treatment resistant OCD and MDD but the results are limited by small sample size and insufficient randomized. controlled data According to the authors other psychiatric indications are currently of a purely experimental nature. Hamani et al 2014 conducted a systematic review of the literature and developed evidence based guidelines on. DBS for OCD that was sponsored by the American Society for Stereotactic and Functional Neurosurgery and the. Congress of Neurological Surgeons CNS and endorsed by the CNS and American Association of Neurological. Surgeons Of 353 articles identified 7 were retrieved for full text review and analysis The quality of the articles was. assigned to each study and the strength of recommendation graded according to the guidelines development. methodology of the American Association of Neurological Surgeons Congress of Neurological Surgeons Joint. Guidelines Committee Of the 7 studies 1 class I and 2 class II double blind randomized controlled trials reported. that bilateral DBS is more effective in improving OCD symptoms than sham treatment The authors concluded that. based on the data published in the literature the following recommendations can be made 1 There is Level I. evidence based on a single class I study for the use of bilateral subthalamic nucleus DBS for the treatment of. medically refractory OCD 2 There is Level II evidence based on a single class II study for the use of bilateral. nucleus accumbens DBS for the treatment of medically refractory OCD 3 There is insufficient evidence to make a. recommendation for the use of unilateral DBS for the treatment of medically refractory OCD The authors noted that. additional research is needed to determine which patients respond to deep brain stimulation and if specific targets. may be more suitable to treat a specific set of symptoms. Professional Societies,American Psychiatric Association APA.
In a Guideline Watch Practice Guideline for the Treatment of Patients with Obsessive Compulsive Disorder the APA. states that new studies are available on deep brain stimulation DBS and other somatic treatments but the overall. strength of evidence for these treatments remains low APA 2013. Other Disorders, Deep brain stimulation DBS has also been investigated for other disorders including Alzheimer s disease Bittlinger. and Muller 2018 Smith et al 2012 Hardenacke et al 2013 impulsive or violent behavior Franzini et al 2005. chronic and poststroke pain Lempka et al 2017 Cruccu et al 2016 Jung et al 2015 NICE 2011 cluster. headache Fontaine et al 2010 and movement disorders of multiple sclerosis Oliveria et al 2017 Hosseini et al. 2012 Mandat et al 2010 Studies investigating DBS for treatment of other conditions are mainly trials with small. sample sizes and short term follow up Further well designed studies are needed to demonstrate the benefits of deep. brain stimulation for these disorders,Professional Societies. American Headache Society AHS, The AHS guideline on the treatment of cluster headache gave a recommendation of probably ineffective for use of. deep brain stimulation for treating cluster headaches Robbins et al 2016. Directional Deep Brain Stimulation, In a prospective double blind trial Dembek et al 2017 investigated whether directional deep brain stimulation. DBS of the subthalamic nucleus in Parkinson s disease PD offers increased therapeutic windows side effect. thresholds and clinical benefit In 10 patients 20 monopolar reviews were conducted to identify the best stimulation. directions and compare them to conventional circular DBS In addition circular and best directional DBS were directly. compared in a short term crossover Motor outcome was also assessed after an open label follow up of 3 to 6 months. Stimulation in the individual best direction resulted in significantly larger therapeutic windows higher side effect. thresholds and more improvement in hand rotation than circular DBS Rigidity and finger tapping did not respond. differentially to the stimulation conditions There was no difference in motor efficacy or stimulation amplitudes. between directional and circular DBS in the short term crossover Follow up evaluations 3 to 6 months after. implantation showed improvements in motor outcome and medication reduction comparable to other DBS studies with. a majority of patients remaining with a directional setting The authors concluded that directional DBS can increase. side effect thresholds while achieving clinical benefit comparable to conventional DBS However the question of. whether directional DBS improves long term clinical outcome needs to be investigated in the future. Steigerwald et al 2016 evaluated directional deep brain stimulation DBS effects on parkinsonian motor features. and adverse effects of subthalamic neurostimulation Seven Parkinson s disease PD patients were implanted with the. Deep Brain and Cortical Stimulation Page 10 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019.
Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. novel directional DBS system for bilateral subthalamic DBS underwent an extended monopolar review session during. the first postoperative week in which current thresholds were determined for rigidity control and stimulation induced. adverse effects using either directional or ring mode settings Effect or adverse effect thresholds were modified by. directional settings for each of the 14 subthalamic nucleus STN leads Magnitude of change varied markedly. between leads as did orientation of optimal horizontal current steering The authors concluded that directional current. steering through chronically implanted segmented electrodes is feasible alters adverse effect and efficacy thresholds. in a highly individual manner and expands the therapeutic window in a monopolar review as compared to ring mode. DBS According to the authors study limitations include the unblinded and subjective clinical rating of rigidity and. adverse effect thresholds no comparison to standard ring DBS lack of long term clinical follow up and small number. of subjects, Timmermann et al 2015 conducted a prospective multicentre non randomized open label intervention study of an. implantable DBS device Vercise PC System that uses a steerable axial shaping of the electrical stimulation field at. six specialist DBS centers at universities in six European countries Patients were included if they were aged 21 75. years and had been diagnosed with bilateral idiopathic Parkinson s disease with motor symptoms for more than 5. years Participants underwent bilateral implantation in the subthalamic nucleus of a multiple source constant current. eight contact rechargeable DBS system and were assessed 12 26 and 52 weeks after implantation The primary. endpoint was the mean change in unified Parkinson s disease rating scale UPDRS III scores assessed by site. investigators who were aware of the treatment assignment from baseline medication off state to 26 weeks after. first lead implantation stimulation on medication off state Of 53 patients enrolled in the study 40 received a. bilateral implant in the subthalamic nucleus and their data contributed to the primary endpoint analysis Improvement. was noted in the UPDRS III motor score 6 months after first lead implantation compared with baseline with a mean. difference of 23 8 One patient died of pneumonia 24 weeks after implantation which was judged to be unrelated to. the procedure 125 adverse events were reported the most frequent of which were dystonia speech disorder and. apathy 18 serious adverse events were recorded three of which were attributed to the device or procedure one case. each of infection migration and respiratory depression All serious adverse events resolved without residual effects. and stimulation remained on during the study The authors concluded that the multiple source constant current. eight contact DBS system suppressed motor symptoms effectively in patients with Parkinson s disease with an. acceptable safety profile According to the authors future trials are needed to investigate systematically the potential. benefits of this system on postoperative outcome and its side effects This study was funded by Boston Scientific. There is limited evidence comparing directional deep brain stimulation with traditional deep brain stimulation methods. of stimulation Long term follow up of large cohorts are needed to determine the effectiveness and long term results. of directional deep brain stimulation,Responsive Cortical Stimulation. Morrell et al 2011 conducted a multicenter double blind randomized controlled trial that assessed the safety and. effectiveness of responsive cortical stimulation as an adjunctive therapy for partial onset seizures in adults with. medically refractory epilepsy A total of 191 adults with medically intractable partial epilepsy were implanted with a. responsive neurostimulator connected to depth or subdural leads placed at 1 or 2 predetermined seizure foci The. neurostimulator was programmed to detect abnormal electrocorticographic activity One month after implantation. subjects were randomized 1 1 to receive stimulation in response to detections treatment or to receive no stimulation. sham Efficacy and safety were assessed over a 12 week blinded period and a subsequent 84 week open label. period during which all subjects received responsive stimulation Seizures were significantly reduced in the treatment. compared to the sham group during the blinded period and there was no difference between the treatment and sham. groups in adverse events During the open label period the seizure reduction was sustained in the treatment group. and seizures were significantly reduced in the sham group when stimulation began There were significant. improvements in overall quality of life and no deterioration in mood or neuropsychological function According to the. authors responsive cortical stimulation reduces the frequency of disabling partial seizures is associated with. improvements in quality of life and is well tolerated with no mood or cognitive effects This study provides Class I. evidence that responsive cortical stimulation is effective in significantly reducing seizure frequency for 12 weeks in. adults who have failed 2 or more antiepileptic medication trials 3 or more seizures per month and 1 or 2 seizure foci. The RNS system manufacturer NeuroPace sponsored this study and participated in acquisition of data statistical. analysis study supervision and approval of the data Therefore a conflict of interest may exist. Heck et al 2014 published the final two year results of the responsive neurostimulation RNS pivotal randomized. multicenter double blinded controlled trial described above Morrell et al 2011 to assess the safety and. effectiveness of responsive stimulation at the seizure focus as an adjunctive therapy to reduce the frequency of. seizures in adults with medically intractable partial onset seizures arising from one or two seizure foci Subjects with. medically intractable partial onset seizures from one or two foci were implanted and 1 month postimplant were. randomized 1 1 to active or sham stimulation After the fifth postimplant month all subjects received responsive. stimulation in an open label period OLP to complete 2 years of postimplant follow up All 191 subjects were. randomized The percent change in seizures at the end of the blinded period was 37 9 in the active and 17 3 in. Deep Brain and Cortical Stimulation Page 11 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019. Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. the sham stimulation group The median percent reduction in seizures in the OLP was 44 at 1 year and 53 at 2. years which represents a progressive and significant improvement with time The serious adverse event rate was not. different between subjects receiving active and sham stimulation Adverse events were consistent with the known. risks of an implanted medical device seizures and of other epilepsy treatments There were no adverse effects on. neuropsychological function or mood According to the authors responsive stimulation to the seizure focus reduced. the frequency of partial onset seizures acutely showed improving seizure reduction over time was well tolerated and. was acceptably safe, Jobst et al 2017 reported on the patients from the Morrell et al 2011 and Heck et al 2014 randomized. controlled trial to evaluate the seizure reduction response and safety of brain responsive stimulation in adults with. medically intractable partial onset seizures of neocortical origin Patients with partial seizures of neocortical origin. were identified from prospective clinical trials of a brain responsive neurostimulator RNS System NeuroPace The. seizure reduction over years 2 6 postimplantation was calculated by assessing the seizure frequency compared to a. preimplantation baseline Safety was assessed based on reported adverse events Additional analyses considered. safety and seizure reduction according to lobe and functional area e g eloquent cortex of seizure onset There were. 126 patients with seizures of neocortical onset The average follow up was 6 1 implant years The median percent. seizure reduction was 70 in patients with frontal and parietal seizure onsets 58 in those with temporal neocortical. onsets and 51 in those with multilobar onsets Twenty six percent of patients experienced at least one seizure free. period of 6 months or longer and 14 experienced at least one seizure free period of 1 year or longer Stimulation. parameters used for treatment did not cause acute or chronic neurologic deficits even in eloquent cortical areas The. rates of infection 0 017 per patient implant year and perioperative hemorrhage 0 8 were not greater than with. other neurostimulation devices The authors concluded that brain responsive stimulation represents a safe and. effective treatment option for patients with medically intractable epilepsy including adults with partial onset seizures. of neocortical onset and those with onsets from eloquent cortex. Meador et al 2015 reported on the patients from the Morrell et al 2011 and Heck et al 2014 randomized. controlled trial to evaluate quality of life which was a supportive analysis and for mood which was assessed as a. secondary safety endpoint The study was a multicenter randomized controlled double blinded trial of responsive. neurostimulation in 191 patients with medically resistant focal epilepsy During a 4 month postimplant blinded period. patients were randomized to receive responsive stimulation or sham stimulation after which all patients received. responsive neurostimulation in open label to complete 2years Quality of life QOL and mood surveys were. administered during the baseline period at the end of the blinded period and at year 1 and year 2 of the open label. period The treatment and sham groups did not differ at baseline Compared with baseline QOL improved in both. groups at the end of the blinded period and also at 1year and 2years when all patients were treated At 2years 44. of patients reported meaningful improvements in QOL and 16 reported declines There were no overall adverse. changes in mood or in suicidality across the study Findings were not related to changes in seizures and antiepileptic. drugs and patients with mesial temporal seizure onsets and those with neocortical seizure onsets both experienced. improvements in QOL The authors concluded that treatment with targeted responsive neurostimulation does not. adversely affect QOL or mood and may be associated with improvements in QOL in patients including those with. seizures of either mesial temporal origin or neocortical origin. Bergey et al 2015 reported on patients who were involved in the Morrell et al 2011 and Heck et al 2014. studies and transitioned to this open label study that assessed the long term efficacy and safety of responsive direct. neurostimulation in adults with medically refractory partial onset seizures All participants were treated with a cranially. implanted responsive neurostimulator that delivers stimulation to 1 or 2 seizure foci via chronically implanted. electrodes when specific electrocorticographic patterns are detected RNS System Participants had completed a 2. year primarily open label safety study n 65 or a 2 year randomized blinded controlled safety and efficacy study n. 191 230 participants transitioned into an ongoing 7 year study to assess safety and efficacy The average. participant was 34 11 4 years old with epilepsy for 19 6 11 4 years The median preimplant frequency of. disabling partial or generalized tonic clonic seizures was 10 2 seizures a month The median percent seizure reduction. in the randomized blinded controlled trial was 44 at 1 year and 53 at 2 years and ranged from 48 to 66 over. postimplant years 3 through 6 in the long term study Improvements in quality of life were maintained The most. common serious device related adverse events over the mean 5 4 years of follow up were implant site infection. 9 0 involving soft tissue and neurostimulator explantation 4 7 The authors concluded that acute and. sustained efficacy and safety were demonstrated in adults with medically refractory partial onset seizures arising from. 1 or 2 foci over a mean follow up of 5 4 years This experience supports the RNS System as a treatment option for. refractory partial seizures This study provides Class IV evidence that for adults with medically refractory partial onset. seizures responsive direct cortical stimulation reduces seizures and improves quality of life over a mean follow up of. Loring et al 2015 collected neuropsychological data from subjects participating in the open label arm of a. randomized controlled trial of responsive neurostimulation with the RNS System from Morrell et al 2011 and Heck. et al 2014 Primary cognitive outcomes were the Boston Naming Test BNT and Rey Auditory Verbal Learning. Deep Brain and Cortical Stimulation Page 12 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019.
Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. AVLT test Neuropsychological performance was evaluated at baseline and again following 1 and 2 years of RNS. System treatment Follow up analyses were conducted in patients with seizure onset restricted to either the mesial. temporal lobe or neocortex No significant cognitive declines were observed for any neuropsychological measure. through 2 years When examined as a function of seizure onset region a double dissociation was found with. significant improvement in naming across all patients and for patients with neocortical seizure onsets but not in. patients with mesial temporal lobe MTL seizure onsets In contrast a significant improvement in verbal learning was. observed across all patients and for patients with MTL seizure onsets but not for patients with neocortical onsets. According to the investigators treatment with the RNS System is not associated with cognitive decline when tested. through 2 years, A guideline published by the U S Department of Veterans Affairs in 2014 titled Department of Veterans Affairs. Epilepsy Manual mentioned using the responsive neurostimulation RNS System to treat epilepsy In the. Investigational Treatments section this guideline states that although RNS has positive results in a randomized trial. the overall effectiveness of this device was only slightly superior to vagus nerve stimulation VNS during the blinded. phase of this study The guideline concludes that RNS is currently considered a potential treatment option for patients. with two seizure foci or with a single focus not amenable to resection Husain et al 2014. U S FOOD AND DRUG ADMINISTRATION FDA,Deep Brain Stimulation. Deep brain stimulation is a procedure and therefore not subject to FDA regulation However any medical devices. drugs and or tests used as part of this procedure may require FDA regulation. Parkinson s Disease and Essential Tremor, The FDA approved the Activa Tremor Control System Medtronic on July 31 1997 The device is indicated for. unilateral thalamic stimulation for the suppression of tremor in the upper extremity in patients who are diagnosed. with essential tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor. constitutes a significant functional disability In 2015 the FDA labeled indications for Activa Tremor Control System for. Parkinson s disease was modified to include adjunctive therapy in reducing some of the symptoms in individuals with. levodopa responsive Parkinson s disease of at least 4 years duration that are not adequately controlled with. medication See the following websites for more information. http www accessdata fda gov cdrh docs pdf p960009 pdf. http www accessdata fda gov cdrh docs pdf2 H020007b pdf. https www accessdata fda gov scripts cdrh cfdocs cfpma pma cfm id P960009S229. Accessed October 16 2018, A January 14 2002 Premarket Approval PMA supplement expanded use to include bilateral stimulation of the. internal globus pallidus GPi or the subthalamic nucleus STN as an adjunctive therapy in reducing some of the. symptoms of advanced levodopa responsive Parkinson s disease that are not adequately controlled with medication. Available at http www accessdata fda gov cdrh docs pdf P960009S007b pdf Accessed October 16 2018. On June 12 2015 the FDA approved the Brio Neurostimulation System St Jude Medical an implantable deep brain. stimulation device intended to help reduce the symptoms of Parkinson s disease and essential tremor See the. following website for more information http www accessdata fda gov cdrh docs pdf14 P140009a pdf. Accessed October 16 2018, On September 19 2016 the FDA approved a Premarket Approval PMA application bundles supplement.
P140009 S001 approving the use of the St Jude Medical InfinityTM DBS System One of the Infinity DBS System s. features is a directional lead which will send the electrical impulses only toward its intended target instead of in all. directions as current systems do The FDA approval for the Infinity DBS System is a supplement to an earlier PMA. P140009 for the St Jude Medical Brio Neurostimulation system According to the manufacturer the Infinity DBS. System and the Brio Neurostimulation System have the same indications for use See the following website for more. information http www accessdata fda gov scripts cdrh cfdocs cfpma pma cfm id P140009. Accessed October 16 2018, On December 8 2017 the FDA approved a Premarket Approval PMA application P150031 for the Vercise Deep. Brain Stimulation DBS System Boston Scientific Corp The Vercise DBS System is indicated for use in bilateral. stimulation of the subthalamic nucleus STN as an adjunctive therapy in reducing some of the symptoms of moderate. to advanced levodopa responsive Parkinson s disease PD that are not adequately controlled with medication The. Vercise DBS System includes a Stimulator with DBS Leads for stimulation of selected targets i e the subthalamic. nucleus in the brain DBS Extensions are used to connect the DBS Leads to the Stimulator implanted near the. clavicle The Vercise DBS System utilizes current steering across eight contacts per DBS Lead which is intended to. provide precise positioning of stimulation The Stimulator is controlled by a handheld Remote Control and can be. Deep Brain and Cortical Stimulation Page 13 of 19, UnitedHealthcare Commercial Medical Policy Effective 01 01 2019. Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. programmed by a Clinician Programmer using the Bionic Navigator Software See the following website for more. information https www accessdata fda gov scripts cdrh cfdocs cfpma pma template cfm id p150031. Accessed October 16 2018, On April 15 2003 the Activa Dystonia Therapy System Medtronic received a Humanitarian Device Exemption HDE. from the FDA for unilateral and bilateral stimulation of the internal globus pallidus or the subthalamic nucleus and is. indicated as an aid in the treatment of chronic intractable drug refractory primary dystonia including generalized. and segmental dystonia hemidystonia and cervical dystonia Activa Dystonia Therapy is limited to use in implanting. centers that receive Institutional Review Board IRB approval for the procedure The safety and effectiveness of. Activa Dystonia Therapy have not been established through a full PMA study The therapy is approved for patients. who are seven years of age and older Available at, https www accessdata fda gov scripts cdrh cfdocs cfhde hde cfm id H020007 Accessed October 16 2018. Other Indications, On March 28 2005 the Activa Deep Brain Stimulation Therapy System was designated as a Humanitarian Use.
Device HUD for the treatment of chronic treatment resistant obsessive compulsive disorder OCD in a subset of. patients However the FDA does not list a Humanitarian Device Exemption HDE approval for authorization to market. the device, On February 19 2009 the ReclaimTM Deep Brain Stimulation Therapy device was designated as an HUD for the. treatment of obsessive compulsive disorder OCD This device is indicated for bilateral stimulation of the anterior limb. of the internal capsule AIC as an adjunct to medications and as an alternative to anterior capsulotomy for treatment. of chronic severe treatment resistant OCD in adult patients who have failed at least three selective serotonin. reuptake inhibitors SSRIs See the following website for more information. https www accessdata fda gov cdrh docs pdf5 H050003a pdf Accessed October 16 2018. On April 27 2018 the FDA approved the Medtronic DBS System for Epilepsy for bilateral stimulation of the anterior. nucleus of the thalamus ANT as an adjunctive therapy for reducing the frequency of seizures in individuals 18 years. of age or older diagnosed with epilepsy characterized by partial onset seizures with or without secondary. generalization that are refractory to three or more antiepileptic medications The FDA indicated that the Medtronic. DBS System for Epilepsy has demonstrated safety and effectiveness for patients who average six or more seizures per. month over the three most recent months prior to implant of the DBS system with no more than 30 days between. seizures The Medtronic DBS System for Epilepsy has not been evaluated in patients with less frequent seizures. See the following website for more information, https www accessdata fda gov scripts cdrh cfdocs cfpma pma cfm id P960009S219 Accessed October 16 2018. Responsive Cortical Stimulation, The FDA approved the NeuroPace RNS Neurostimulator System on November 14 2013 The device is indicated as an. adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset. seizures who have undergone diagnostic testing that localized no more than two epileptogenic foci are refractory to. two or more antiepileptic medications and currently have frequent and disabling seizures motor partial seizures. complex partial seizures and or secondarily generalized seizures The RNS System has demonstrated safety and. effectiveness in patients who average three or more disabling seizures per month over the three most recent months. with no month with fewer than two seizures and has not been evaluated in patients with less frequent seizures. The RNS System is contraindicated for, Patients with risk factors for surgical complications such as active systemic infection coagulation disorders such. as the use of antithrombotic therapies or platelet count below 50 000. Patients who have implanted medical devices that deliver electrical energy to the brain. Patients who are unable or do not have the necessary assistance to properly operate the NeuroPace remote. monitor or magnet, The following medical procedures are contraindicated for patients with an implanted RNS System The procedures may.
send energy through the implanted brain stimulation system causing permanent brain damage which may result in. severe injury coma or death Brain damage can occur from any of the listed procedures even if the RNS. neurostimulator is turned off the leads are not connected to the neurostimulator or the neurostimulator has been. removed and any leads or any part of a lead remain. Diathermy procedures high frequency electromagnetic radiation electric currents or ultrasonic waves used to. produce heat in body tissues Patients should not be treated with any type of shortwave microwave or. therapeutic ultrasound diathermy device on any part of the body regardless of whether the device is used to. produce heat,Deep Brain and Cortical Stimulation Page 14 of 19. UnitedHealthcare Commercial Medical Policy Effective 01 01 2019. Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc. Electroconvulsive therapy,Transcranial magnetic stimulation. See the following website for more information, https www accessdata fda gov scripts cdrh cfdocs cfPMA pma cfm id P100026 Accessed October 16 2018. Additional Products,Activa Tremor Control Therapy Medtronic Inc. Activa Parkinson s Control Therapy Medtronic Inc,Activa Dystonia Therapy Medtronic Inc.
Kinetra Neurostimulator Medtronic Inc,Soletra Neurostimulator Medtronic Inc. CENTERS FOR MEDICARE AND MEDICAID SERVICES CMS, Medicare covers deep brain stimulation DBS when specific criteria are met See the National Coverage. Determination NCD for Deep Brain Stimulation for Essential Tremor and Parkinson s Disease 160 24 Local. Coverage Determinations LCDs do not exist at this time. Medicare does not have an NCD for responsive cortical stimulation LCDs do not exist at this time. Accessed October 24 2018,REFERENCES, American Association of Neurological Surgeons Dystonia 2018 Available at. https www aans org Patients Neurosurgical Conditions and Treatments Dystonia Accessed October 31 2018. American Psychiatric Association APA Guideline Watch March 2013 Practice Guideline for the Treatment of. Patients With Obsessive Compulsive Disorder Available at. http psychiatryonline org pb assets raw sitewide practice guidelines guidelines ocd watch pdf Accessed October. Andrews C Aviles Olmos I Hariz M et al Which patients with dystonia benefit from deep brain stimulation A. metaregression of individual patient outcomes J Neurol Neurosurg Psychiatry 2010 Dec 81 12 1383 9. Baldermann JC Sch ller T Huys D et al Deep Brain Stimulation for Tourette Syndrome A Systematic Review and. Meta Analysis Brain Stimul 2016 Mar Apr 9 2 296 304. Bergey GK Morrell MJ Mizrahi EM et al Long term treatment with responsive brain stimulation in adults with. refractory partial seizures Neurology 2015 Feb 24 84 8 810 7. Berlim MT McGirr A Van den Eynde F et al Effectiveness and acceptability of deep brain stimulation DBS of the. subgenual cingulate cortex for treatment resistant depression a systematic review and exploratory meta analysis J. Affect Disord 2014 Apr 159 31 8, Bittlinger M M ller S Opening the debate on deep brain stimulation for Alzheimer disease a critical evaluation of. rationale shortcomings and ethical justification BMC Med Ethics 2018 Jun 11 19 1 41. Chang B Xu J Deep brain stimulation for refractory temporal lobe epilepsy a systematic review and meta analysis. with an emphasis on alleviation of seizure frequency outcome Childs Nerv Syst 2018 Feb 34 2 321 327. Cruccu G Garcia Larrea L Hansson P et al EAN guidelines on central neurostimulation therapy in chronic pain. conditions Eur J Neurol 2016 Oct 23 10 1489 99, Dembek TA Reker P Visser Vandewalle V et al Directional DBS increases side effect thresholds A prospective.
double blind trial Mov Disord 2017 Aug 26, ECRI Institute Brio Neurostimulation System St Jude Medical for Treating Symptoms of Parkinson s Disease May. 2017 Archived, ECRI Institute Clinical Comparison Overview of Three Deep Brain Stimulators for Treating Parkinson s Disease. February 2018, ECRI Institute Custom Product Brief Infinity Deep Brain Stimulation System Abbott Laboratories for Treating. Advanced Parkinson s Disease February 2018, ECRI Institute Custom Product Brief Neuropace RNS Systems Neuropace Inc for Treating Epilepsy September 4. ECRI Institute Custom Product Brief Activa SC RC and PC Neurostimulators Medtronic plc for Treating Parkinson s. Disease February 2018,Deep Brain and Cortical Stimulation Page 15 of 19.
UnitedHealthcare Commercial Medical Policy Effective 01 01 2019. Proprietary Information of UnitedHealthcare Copyright 2019 United HealthCare Services Inc.


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