Blue Cross Blue Shield - Iowa DBS Coverage Update | OpenPayer
CurrentBlue Cross Blue Shield - IowaPolicy 07.01.59
Deep Brain Stimulation (DBS)
Medical policy governing coverage and medical necessity criteria for deep brain stimulation (DBS) procedures and device replacement/revision for members of Blue Cross Blue Shield - Iowa (Wellmark). Applies to DBS indications including Parkinson disease, essential tremor, dystonia, and medically refractory epilepsy, and lists investigational indications.
Policy Summary
PayerBlue Cross Blue Shield - Iowa
PolicyDeep Brain Stimulation (DBS)
Policy CodePolicy 07.01.59
Change TypeNo material change
Effective DateNov 1, 2000
Next Review DateN/A
Key ActionSubmit prior authorization documentation demonstrating the patient meets policy-specific medical necessity criteria (diagnosis, prior therapy trials, and relevant severity measures).
No material clinical or coverage changes in this revision.
multipleindications evaluated
≥7min age primary dystonia
≥3 AEDs & ≥6/moepilepsy threshold
110largest RCT (SANTE) patients
82–91%tremor responder rate
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Coverage Criteria and Indications
Primary Dystonia (Coverage)
Covered when ALL of the following are met
Primary Dystonia coverage criteria: Unilateral or bilateral DBS of the globus pallidus interna (GPi) or subthalamic nucleus (STN) for primary (isolated) dystonia (generalized, segmental, hemidystonia, or cervical/torticollis) may be considered medically necessary.age >= 7 years
Chronic intractable (drug‑refractory) dystonia; target choice GPi or STN per labeling.
Parkinson Disease (Coverage)
Covered when ALL of the following are met
Parkinson disease DBS criteria: Unilateral or bilateral DBS of GPi or STN is medically necessary for an individual with Parkinson disease who had a good prior response to levodopa or other pharmacologic therapy but is now medically refractory (motor complications not controlled by pharmacologic therapy).documented prior levodopa responsiveness
Additionally the patient must meet at least one: motor UPDRS off‑med >=30 after ~12 hours off medication, OR PD duration >=4 years.
Supportive thalamic DBS indication: Unilateral or bilateral thalamic DBS may be considered medically necessary for disabling, medically unresponsive tremor due to essential tremor or Parkinson disease.disabling tremor unresponsive to medical therapy
See policy guidelines for definition of disabling, medically unresponsive tremor.
Medically Refractory Epilepsy (Coverage)
Covered when ALL of the following are met
ANT DBS for refractory epilepsy: DBS of the anterior nucleus of the thalamus (ANT) may be considered medically necessary for individuals 18 years of age or older with focal (partial‑onset) seizures (with or without secondary generalization) who are medically refractory to at least 3 antiepileptic drugs (AEDs).age >= 18; failed >=3 AEDs
FDA approval and SANTE trial data support indication; device has demonstrated effectiveness for patients averaging >=6 focal seizures/month over the 3 most recent months.
Minimum seizure frequency: Documented baseline seizure frequency consistent with trial eligibility to allow assessment of effect (patient averages 6 or more focal seizures per month over the most recent 3 months, with no more than 30 days between seizures).>=6 focal seizures/month over 3 months; <=30 days between seizures
SANTE trial eligibility and device labeling referenced.
Surgical candidacy and prior therapies:
Replacement or Revision of DBS (Coverage)
Covered when ALL of the following are met
Replacement or revision criteria: Replacement or revision of an implanted DBS system may be considered medically necessary when the individual meets the applicable indication criteria for DBS, previously derived clinical benefit from the existing stimulator is documented, and the existing generator/lead/electrode/programmer is no longer under warranty and cannot be repaired.documented prior clinical benefit; device not repairable/warranty expired
Replacement/revision should reference prior indication and operative/device documentation.
Indications covered with criteria
Covered when ALL of the following are met for the specific condition
Essential tremor: Tremor causing significant limitation in daily activities AND inadequate control by maximal tolerated medication for at least 3 months prior to implant.medication failure >=3 months
Contraindications to DBS must be absent (see policy guidelines).
Medically refractory epilepsy (device‑specific): Individual >=18 years with focal‑onset epilepsy refractory to >=3 AEDs and averaging >=6 seizures/month (3‑month window) consistent with Medtronic DBS System for Epilepsy labeling; not a candidate for resective surgery or failed resection.>=3 AED failures; >=6 seizures/month
ANT DBS labeling (SANTE) limited to this seizure frequency and population.
Parkinson disease and primary dystonia: Indications consistent with device labeling for unilateral or bilateral stimulation of appropriate targets (STN, GPi) when symptoms are inadequately controlled by medication or when medication complications (eg, dyskinesia, motor fluctuations) warrant DBS.
Evidence-supported clinical indications
Clinical scenarios supported by the evidence in the document:
Thalamic DBS for tremor: Patients with essential tremor or Parkinsonian tremor refractory to medical therapy may achieve clinically significant tremor suppression with thalamic stimulation; observational and TEC assessments report 82–91% of operated sides with clinically significant suppression and durable effects up to 5 years in some series.disabling tremor refractory to meds
Evidence includes TEC assessment and long‑term observational studies.
GPi or STN DBS for advanced Parkinson disease: Patients with levodopa‑responsive Parkinson disease and disabling motor complications despite optimized medical therapy show improved motor function, ADLs, quality of life, and reduced medication requirements with GPi or STN DBS in randomized trials and systematic reviews.documented levodopa responsiveness and inadequate control on medical therapy
Supported by multiple RCTs and reviews including Schuepbach et al and Perestelo‑Perez et al.
Covered with clinical criteria
Coverage considerations when assessing aDBS/DBS:
aDBS for Parkinson disease: Candidate must have levodopa‑responsive Parkinson disease with uncontrolled motor symptoms despite optimized medical therapy; device must be compatible with adaptive programming and documentation should include baseline 'On' time without troublesome dyskinesia and follow‑up home diary data demonstrating benefit with single‑ or dual‑threshold aDBS.success rates reported: single‑threshold 78.9% and dual‑threshold 91% in trial cohorts
ADAPT‑PD randomized crossover trial demonstrates feasibility; safety data include overall AEs ~78.8% and serious AEs ~17.6%.
Primary dystonia clinical context: Candidate has primary (isolated) dystonia with significant functional impairment despite pharmacologic therapy and botulinum toxin when applicable; target selection GPi or STN and outcomes should reference validated scales (eg, BFMDRS, TWSTRS); RCTs have shown improvement in dystonia severity versus sham during blinded periods.N/A
Kupsch et al. and Volkmann et al. RCTs demonstrated blinded‑period benefit.
Primary Dystonia — Evidence Summary
Primary dystonia — available evidence and outcomes
Primary dystonia RCT evidence: Two randomized controlled trials (Kupsch et al. and Volkmann et al.) demonstrated greater improvement in dystonia severity scores with active GPi DBS versus sham stimulation during blinded study periods; pooled analyses and case series show sustained motor and disability improvements at 6 months and longer (mean follow‑up ~32 months).
FDA humanitarian device approval and systematic reviews support likely benefit in selected patients.
Tardive dyskinesia and tardive dystonia — available evidence and outcomes
Tardive dystonia RCT evidence: A single randomized trial (Gruber et al. 2018; n=25) comparing pallidal DBS versus sham did not find a statistically significant between‑group difference in dystonia severity at 3 months; the trial was underpowered (planned N=48) and reported several adverse events including 3 serious events.
Observational series report symptom reductions in selected patients but randomized evidence is limited and inconclusive.
Observational evidence: Case series and observational reports show substantial symptom reductions (>40% in some series) at 6–12 months in refractory tardive syndromes, supporting potential benefit in selected refractory patients despite limited RCT evidence.
Interpretation constrained by study size and design limitations.
Epilepsy — Clinical Context
Drug-resistant epilepsy — clinical context
Epilepsy candidacy context: DBS is considered an adjunctive treatment option for drug‑resistant epilepsy in patients who are not candidates for resective surgery; drug resistance is defined per ILAE as failure of adequate trials of 2 appropriately chosen and tolerated antiepileptic drugs.ILAE definition: failure of 2 AED trials
Multidisciplinary evaluation is recommended to determine resective candidacy.
Role of comparators: Alternative or adjunctive therapies include optimized pharmacologic therapy, VNS, or ketogenic diet; DBS has been evaluated for multiple brain targets with variable evidence across targets.N/A
Evidence base includes RCTs and observational studies; benefits and risks should be weighed versus VNS and other options.
Eligibility for DBS in refractory epilepsy (criteria synthesized from trial eligibility and context)
Covered when ALL of the following are met
Patient selection for epilepsy DBS: Patient has drug‑refractory epilepsy with documentation of prior antiepileptic drug trials (trial inclusion in major DBS trials commonly required failure of >=3 AEDs though ILAE drug‑resistant definition requires failure of 2), is not a candidate for resective surgery or has failed resection, and has focal (partial‑onset) seizures with or without secondary generalization.failed AEDs: trials typically >=3 in RCTs; ILAE definition requires failure of 2
Prior multidisciplinary epilepsy surgery evaluation required.
Baseline seizure burden documented: Documented baseline seizure frequency by diary consistent with trial eligibility (eg, SANTE required average >=6 partial seizures/month over the 3 most recent months with no more than 30 days between seizures).>=6 partial seizures/month over prior 3 months; <=30 days between seizures
SANTE trial and device labeling inform this threshold.
Coverage logic based on efficacy and safety evidence
Coverage considerations informed by the evidence summarized here (epilepsy and Tourette syndrome):
General requirements: Candidate must have the target condition (eg, drug‑refractory epilepsy or severe disabling Tourette syndrome) with documentation of inadequate response to optimal conventional therapies and multidisciplinary assessment when relevant.documented failure of standard therapies
For Tourette, behavioral therapy and multiple pharmacologic agents should have been tried; for epilepsy, prior AED trials and resective candidacy assessment required.
Evidence of benefit: Randomized trials show mixed short‑term benefits and observational long‑term follow‑up suggests seizure reductions in some patients; study limitations (small RCTs, short blinded phases, and uncontrolled follow‑up) limit interpretation of net health benefit.
SANTE showed benefit in month 3 but mixed results overall; serious adverse events relatively common.
Safety considerations: Serious device‑ or surgery‑related adverse events have been reported (eg, infections, lead migration, neuropsychiatric effects); rates reported in epilepsy series approach one‑third of patients over longer follow‑up and should be weighed against potential benefits.
Summary criteria reflecting current evidence strength
Evidence and study limitations informing coverage decisions
Tourette evidence limitations: Most Tourette studies are small and heterogeneous in targets; two RCTs >=15 patients produced discordant results and high rates of serious adverse events have been reported.
Supports restricted coverage or case‑by‑case consideration pending stronger evidence.
Cluster headache and facial pain: Randomized evidence for posterior hypothalamus stimulation in chronic cluster headache (n=11 crossover RCT) did not show benefit in the randomized phase; pooled small studies for facial pain show short‑term VAS reductions but limited longer‑term pooled data.
Evidence inconsistent; further RCTs needed.
Treatment‑resistant depression: Multiple targets have been evaluated with mixed results; some RCTs terminated for futility and overall evidence does not establish effective targets—use generally reserved for research or highly selected cases.
Two RCTs terminated for futility; adverse psychiatric events noted.
Conditional coverage considerations
Coverage contingent on demonstration of treatment‑resistant disorder and consideration of existing evidence:
General candidate requirements: Patient has treatment‑resistant major depressive disorder or obsessive‑compulsive disorder with substantial functional impairment and documentation of failure of multiple adequate trials of pharmacologic and psychotherapeutic treatments (eg, >=3–4 antidepressant trials for depression; CBT and multiple medication trials for OCD); ECT and other guideline therapies tried where applicable.failed multiple adequate trials (commonly >=3–4 for depression)
Planned DBS target must be specified and evidence basis considered given mixed trial results.
Severity and duration considerations: Severity thresholds used in trials include chronic episode duration (eg, >=12 months) and OCD baseline Y‑BOCS >=24 for severe illness; response definitions vary by indication (eg, >=50% for depression, >=35% Y‑BOCS for OCD).Y‑BOCS >=24 for severe OCD; response definitions as per trials
Documentation should include baseline severity scales and prior treatment history.
Evidence summaries by indication
Evidence summaries by indication — clinical decision should consider the following findings
OCD: Systematic reviews and RCTs suggest DBS may reduce OCD symptoms in some patients, but studies are small, heterogeneous, and at risk of bias; optimal target not established and adverse events including serious complications have been reported.
Responder usually defined as >=35% reduction in Y‑BOCS in trials.
MS tremor: Meta‑analyses of nonrandomized studies report heterogeneous improvements in tremor scores after DBS, but high heterogeneity and publication bias limit conclusions and current literature does not support DBS for MS tremor.
Evidence insufficient to support routine use.
Chronic pain and other indications: Evidence for chronic pain, alcohol use disorder, anorexia nervosa, Alzheimer disease, Huntington disease, and other exploratory indications is limited (small RCTs or case series) and inadequate to determine net health benefit; use should generally be limited to research settings.
Larger, controlled trials needed.
Guideline-based coverage positions by indication
Coverage stance and clinical recommendations vary by indication; extract of guideline statements follows
Essential tremor guidance: AAN guidance indicates bilateral thalamic DBS may be used for medically refractory limb tremor (level C, possibly effective); insufficient evidence for head or voice tremor.medically refractory tremor after appropriate trials
AAN 2011 update reaffirmed prior conclusions.
Parkinson disease guidance: Guidelines (Congress of Neurological Surgeons, AAN) support DBS for PD refractory to best medical therapy; both STN and GPi stimulation are effective and target selection depends on clinical goals such as medication reduction and dyskinesia control.PD refractory to best medical treatment
NICE and other guidance recommend offering DBS when medical therapy is inadequate.
Refractory epilepsy guidance:
Deep brain stimulation (DBS) is considered investigational when the specific coverage criteria in this policy are not met. Examples of indications regarded as investigational include, but are not limited to: alcohol addiction, Alzheimer disease, anorexia nervosa, chronic pain syndromes, cluster headache/facial pain, treatment‑resistant depression, epilepsy except as specifically indicated in this policy, Huntington disease, multiple sclerosis (MS) tremor, obsessive‑compulsive disorder (OCD), tardive dyskinesia/tardive dystonia, and Tourette syndrome. Adaptive deep brain stimulation (aDBS) for Parkinson disease is also listed as investigational in this policy.
DBS implantation may be contraindicated and therefore inappropriate for coverage when the individual is not a good surgical risk because of unstable medical problems or the presence of a cardiac pacemaker, requires repeated MRI for ongoing care, has dementia that interferes with cooperation, or received botulinum toxin injections within the prior 6 months. These conditions should be documented and considered when assessing surgical candidacy.
For evidence selection the review excluded studies with duplicative or overlapping populations; only methodologically credible comparative prospective trials (preferably randomized controlled trials) and, where necessary, comparative observational studies were used to assess efficacy and single‑arm studies were used to assess longer‑term outcomes and adverse events.
This section focuses on DBS for primary dystonia and Parkinson disease; other conditions are not the primary topic here. Neurodestructive procedures (e.g., thalamotomy, pallidotomy) are described as alternate, irreversible options, whereas DBS is presented as a reversible alternative to those neurodestructive procedures.
Patients who are appropriate candidates for resective epilepsy surgery are not the intended population for DBS under the epilepsy criteria in this policy. DBS is aimed at individuals with drug‑refractory epilepsy who are not candidates for resective surgery (for example, multifocal onset or generalized onset) or who have failed prior resective surgery.
Consistent with trial populations and guideline context, DBS as described in this policy is intended for individuals who are not candidates for focal resective surgery; patients who are suitable candidates for resective procedures should be evaluated for surgery rather than DBS.
DBS is considered experimental or uncertain when there is no demonstrated benefit over existing therapies or when available studies are small, underpowered, heterogeneous, or otherwise methodologically limited. The policy highlights that a lack of credible comparative evidence or incomplete reporting of primary endpoints can leave the net health benefit uncertain and supports restricting coverage to indications with adequate evidence.
No additional explicit exclusions are listed in this fragment beyond those specified elsewhere in the policy. Evidence limitations and indication‑specific summaries in the document inform investigational and coverage determinations rather than listing further categorical exclusions in this section.
DBS for major depressive disorder remains investigational in this policy. Multiple brain regions have been evaluated, but randomized evidence is inconsistent (several RCTs were terminated for futility or showed no significant benefit) and the optimal target(s) and risk–benefit profile have not been established; thus DBS for treatment‑resistant depression is reserved for research or is considered investigational outside of trial settings.
The available literature does not currently support DBS for tremor related to multiple sclerosis. Due to limited, nonrandomized studies, small sample sizes, and evidence of heterogeneity and publication bias, DBS for MS tremor is not supported by the evidence summarized in this policy.
Evidence is insufficient to support thalamic DBS for head or voice tremor. For epilepsy, guidance from NICE recommends that DBS targeting the anterior thalamus be used only with special arrangements for clinical governance, consent, audit, or research, and that other epilepsy targets be restricted to research settings; these limitations reflect uncertainty about efficacy and governance requirements for non‑standard targets.
Use of DBS for indications listed as investigational in this policy is considered not medically necessary or investigational because the evidence is insufficient to demonstrate an improvement in net health outcome for those indications.
Adaptive deep brain stimulation (aDBS) is addressed as a device programming feature; use of aDBS beyond device labeling limitations—such as in bilaterally implanted neurostimulators or with more than one implanted neurostimulator—is not supported by the referenced FDA labeling and is considered investigational when used outside labeled device constraints.
This fragment does not contain explicit not‑medically‑necessary (NMN) statements beyond the investigational listings; determinations that a procedure is NMN would depend on absence of evidence of clinical benefit for the specific indication and on failure to meet the policy's documented criteria.
In selected populations (for example, primary dystonia, Parkinson disease, and thalamic DBS for essential tremor) the evidence supports efficacy; the document does not broadly label these procedures as not medically necessary when policy criteria are met. Instead, the policy uses evidence summaries to define which indications are covered versus investigational.
A randomized controlled trial of pallidal DBS for tardive dystonia (Gruber et al. 2018) with 25 randomized patients did not find a statistically significant between‑group difference at 3 months and was underpowered relative to its planned sample size; this limited randomized evidence contributes to the policy designation of investigational or uncertain for some tardive syndromes.
DBS should not be used for patients or populations that were not represented in the trials or for whom required documentation of drug resistance and surgical ineligibility is lacking. For example, epilepsy trials required documentation of multiple failed antiepileptic medication trials and specified baseline seizure burden; applying DBS to patients without those documented prerequisites is not supported by the trial evidence.
DBS is not clearly medically necessary for patients who have not had adequate trials of standard therapies or where expected benefits do not outweigh known risks; the policy emphasizes documenting prior conservative treatments, failed medication trials, and in some indications prior consideration of neuroablative procedures or alternative neuromodulation.
Given inconsistent randomized controlled trial results, small study sizes, and heterogeneous targets across many indications, DBS may be considered not medically necessary for those indications when criteria for refractory disease and anticipated benefit are not met; several RCTs for psychiatric targets were stopped for futility and findings do not consistently demonstrate net health benefit.
DBS targeting ventral capsule/ventral striatum or subgenual cingulate for treatment‑resistant depression is not supported by positive randomized controlled trial evidence in this policy excerpt and therefore would generally be considered not medically necessary outside clinical trials.
Use of DBS for MS‑related tremor is not supported by current literature in this policy and may be considered not medically necessary based on the limited and low‑quality evidence available.
Use of thalamic DBS for head or voice tremor remains unproven due to insufficient data. For epilepsy, NICE recommends that anterior thalamic DBS be used only with special governance, consent, and audit or in research contexts; DBS for non‑anterior thalamic epilepsy targets is recommended only in research — accordingly, such uses may be considered not medically necessary outside those research/governance arrangements.
Procedure, Device, and Programming Codes
See Codes table referenced in documentmixed
No codes listed
No explicit codes in this sectionmixed
No codes listed
DBS implantation without microelectrode recordingCPTCovered
61863
Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site, without use of intraoperative microelectrode recording; first array
61864
Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site, without use of intraoperative microelectrode recording; each additional array
DBS implantation with microelectrode recordingCPTCovered
61867
Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site, with use of intraoperative microelectrode recording; first array
61868
Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site, with use of intraoperative microelectrode recording; each additional array
Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array
61886
Insertion or replacement of cranial neurostimulator pulse generator or receiver; with connection to 2 or more electrode arrays
Device analysis and programmingCPTCovered
95970
Electronic analysis of implanted neurostimulator pulse generator/transmitter without programming
95983
Electronic analysis of implanted neurostimulator pulse generator/transmitter with brain neurostimulator programming, first 15 minutes face-to-face
95984
Electronic analysis of implanted neurostimulator pulse generator/transmitter with brain neurostimulator programming, each additional 15 minutes
Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
L8686
Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8687
Implantable neurostimulator pulse generator, single array, non rechargeable, includes extension
L8688
Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
1–10 of 11
1/2
Seizure frequency threshold for ANT DBS in epilepsy
Seizure frequency thresholdAverage ≥6 focal (partial-onset) seizures per month over the 3 most recent months prior to implant, with no more than 30 days between seizures
Age requirement for ANT DBSIndividual must be ≥18 years of age
Resection candidacyPatient must not be a candidate for resective epilepsy surgery or must have failed prior resective epilepsy surgery
Parkinson disease duration / UPDRS threshold
Prior Authorization, Documentation, and Denial Triggers
Documentation Required
Medical necessity documentation required
Medical necessity criteria must be documented for prior authorization. Prior authorization requests should clearly demonstrate that the patient meets policy‑specific medical necessity criteria for the requested DBS indication, including diagnosis, baseline severity measures, prior therapies tried and their duration, response to prior medications (e.g., documented levodopa responsiveness for Parkinson disease), and evidence of clinical benefit from any prior DBS when applicable.
Document diagnosis and relevant baseline severity scales (e.g., UPDRS motor score, seizure frequency, YGTSS).
For Parkinson disease, document prior good response to levodopa or other pharmacologic therapy and current motor complications despite medication.
For epilepsy, document drug‑resistant epilepsy per ILAE definitions and baseline seizure frequency (see epilepsy candidacy).
Prior Authorization
Prior authorization for DBS
Prior authorization is expected for DBS procedures. Requests must specify the clinical indication, prior conservative treatments attempted and failed, refractory status confirmation, and that guideline‑recommended prerequisites have been met.
Background and Scope
Deep brain stimulation involves stereotactic placement of electrodes into central nervous system nuclei (examples include thalamus, globus pallidus interna, and subthalamic nucleus) and is used as an alternative to neuroablative procedures for indications such as essential tremor and Parkinson disease. The therapy has established evidence for specific targets in selected indications, while evidence for many other neurologic and psychiatric disorders remains limited.
DefinitionTremor causing significant limitation in daily activities and inadequately controlled by maximal medication dosing for at least 3 months prior to implant
Functional criterionSignificant limitation in activities of daily living attributed to tremor (disabling)
Prior therapy requirementInadequate control despite maximal tolerated medication for ≥3 months before considering DBS
United Parkinson Disease Rating Scale (UPDRS) — scale description
Scale componentsUPDRS includes mentation/behavior/mood, activities of daily living (ADL), and motor sections assessed by interview and exam
Scoring rangeTotal possible score 0 to 199 (199 = worst disability; 0 = no disability)
Coding & Billing Guidance
Note
Note
Note
Note
Note
DBS implantation without microelectrode recordingCPTCovered
61863
Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site, without use of intraoperative microelectrode recording; first array
61864
Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site, without use of intraoperative microelectrode recording; each additional array
DBS implantation with microelectrode recordingCPTCovered
61867
Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site, with use of intraoperative microelectrode recording; first array
61868
Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site, with use of intraoperative microelectrode recording; each additional array
Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array
61886
Insertion or replacement of cranial neurostimulator pulse generator or receiver; with connection to 2 or more electrode arrays
Device analysis and programmingCPTCovered
95970
Electronic analysis of implanted neurostimulator pulse generator/transmitter without programming
95983
Electronic analysis of implanted neurostimulator pulse generator/transmitter with brain neurostimulator programming, first 15 minutes face-to-face
95984
Electronic analysis of implanted neurostimulator pulse generator/transmitter with brain neurostimulator programming, each additional 15 minutes
Not a candidate for resective epilepsy surgery or has failed resective surgery; if a VNS is present the patient agrees to have it turned off and generator removed prior to ANT DBS implantation.
N/A
Multidisciplinary epilepsy surgery evaluation should document ineligibility for resection.
refer to device labeling for specifics
Adaptive DBS programming features may have device‑specific labeling restrictions.
DBS target selection:
Choice between GPi and STN stimulation should be individualized; comparative evidence is mixed without clear superiority of one target over the other.
individualized decision
Meta‑analyses show inconsistent comparative results.
Directional leads and aDBS: Directional leads and adaptive DBS are device innovations that may widen therapeutic window or allow event‑triggered adjustment of stimulation; evidence includes prospective crossover studies and aDBS randomized trials demonstrating feasibility and defined success rates.device‑specific selection
Clinical advantages vary and programming features have labeling constraints.
Multidisciplinary evaluation: Evaluation by an epilepsy surgery team documenting that resective surgery is not feasible or indicated and that alternative therapies (optimized AEDs, VNS, ketogenic diet when applicable) have been considered or attempted.N/A
Documentation should support that patient is not a resective candidate.
Documented in long‑term follow‑up and systematic reviews.
Position statements indicate DBS may be considered for focal‑onset epilepsy refractory to >=2 appropriately dosed medications and for seizures not amenable to resection; NICE recommends ANT DBS only with special governance/consent/audit or research and other targets primarily in research contexts.
failure of >=2 appropriately dosed AEDs
ASFN and NICE guidance cited.
Tourette and OCD guidance: Guidelines note DBS may benefit severe, treatment‑refractory Tourette syndrome and medically refractory OCD, but optimal targets are not established and evidence is limited; use generally reserved for specialized centers and selected patients.severe refractory disease after standard therapies
AAN, Stereotactic/Neurosurgery society, and CNS guidance referenced.
UPDRS / duration threshold (either/or)
Motor UPDRS off-med score ≥30 (after ~12 hours off medication) OR Parkinson disease duration ≥4 years
Levodopa responsivenessDocumented good prior response to levodopa or other pharmacologic therapy is required
Indication contextMotor complications not controlled by pharmacologic therapy (medically refractory)
TargetsGPi or STN stimulation (unilateral or bilateral)
Seizure frequency for DBS epilepsy
Minimum documented baseline seizure burdenAverage ≥6 focal seizures per month over the 3 most recent months prior to implant (no more than 30 days between seizures)
Drug resistance definitionFailure of adequate trials of antiepileptic drugs (ILAE definition: failure of 2 AEDs; trials for device labeling/trials used ≥3 AED failures)
Documentation recommendedBaseline seizure diary and multidisciplinary epilepsy surgery evaluation showing non‑resectability
Medication trial duration for essential tremor
Medication trial duration for ET prior to DBSInadequate control by maximal tolerated medication dosing for at least 3 months before implant
Functional impactTremor must cause significant limitation in daily activities (disabling) despite medical therapy
Contraindication noteDocument absence of contraindications (see policy guidelines) prior to implant
Number of failed antiepileptic medications
Number of failed AEDs (typical trial inclusion)Refractory to 3 or more antiepileptic medications as used in major trials and device labeling
ILAE definition referenceILAE defines drug‑resistant epilepsy as failure of adequate trials of 2 tolerated, appropriately chosen and administered AEDs
Documentation to submitPrior antiepileptic drug treatment history and demonstration of drug resistance (medication names, doses, durations) for prior authorization
Responder threshold
Responder definition (epilepsy)≥50% reduction in seizure frequency (commonly used threshold in trials to define responder status)
Outcome measuresResponder assessed by diary‑recorded seizure counts and study-specific endpoints (electrographic seizure reductions reported in some trials)
Follow-up contextResponder rates and durability vary by study; blinded-phase outcomes often reported at 3 months with longer-term follow-up reported in some cohorts up to several years
Prior therapy trials (e.g., ≥3 AEDs for epilepsy, adequate medication trials and botulinum toxin for tremor/dystonia, multiple antidepressant and ECT for depression).
For PD candidates, document levodopa responsiveness and disease duration/UPDRS motor scores as required.
Prior Authorization
Specify device, stimulation target, and indication
Prior authorization must identify the requested device type, specific stimulation target(s), and the exact indication. For adaptive DBS (aDBS) requests, specify that the therapy is adaptive versus conventional (continuous) DBS and indicate the target nucleus (e.g., STN, GPi, ANT, thalamus, VC/VS, subcallosal cingulate).
State whether request is for adaptive DBS (aDBS) or conventional/continuous DBS.
List target brain structure(s) (e.g., STN, GPi, thalamus/VENTRAL intermediate nucleus, anterior nucleus of thalamus).
Include device make/model if known (e.g., Medtronic Percept™ PC, Medtronic DBS System for Epilepsy).
Prior Authorization
Confirm refractory epilepsy status and governance
For epilepsy, prior authorization should confirm refractory disease and governance arrangements. Ensure documentation shows that the individual meets eligibility (focal onset seizures, age ≥18 for FDA‑labeled ANT DBS, average ≥6 focal seizures/month as applicable) and that resective surgery is not an option or has failed. Where guidance (e.g., NICE) advises, DBS for epilepsy should be provided with special clinical governance, consent, and audit or research arrangements.
Document seizure type (focal/partial onset) and frequency (e.g., ≥6 focal seizures/month with no more than 30 days between seizures for Medtronic ANT indication).
Confirm prior failure of ≥3 appropriate AEDs and that patient is not a candidate for resective surgery or has failed resection.
Note any governance/research arrangements or special consenting/audit processes when indicated by guidance.
Billing Rule
Prior authorization for DBS procedures and coding
Prior authorization and claims should reference the specific CPT and HCPCS procedure and device codes for DBS implantation, revisions, replacements, and programming. Provide operative details (number of arrays/leads, unilateral vs bilateral) to support correct coding.
Include CPT codes for implantation and related procedures (see coding block).
Document whether microelectrode recording was used and number of arrays/leads to support selection of primary vs additional array codes.
Provide device model and HCPCS/device descriptor codes when available.
Billing Rule
Device and programming codes listed
Device and programming codes to report provider services include stereotactic implantation CPT codes, electronic analysis and programming CPT codes, and HCPCS device supply codes. Use appropriate CPT/HCPCS, revenue and ICD diagnosis codes on the prior authorization and subsequent claim.
Covered CPT examples: 61863, 61864 (stereotactic implantation, first and additional arrays); 61867–61886 series for implantation with microelectrode recording and pulse generator insertion.
Programming/analysis CPTs: 95970 (electronic analysis without programming), 95983 (analysis with programming, first 15 minutes), 95984 (each additional 15 minutes).
Representative HCPCS/Codes: C1767 (generator non‑rechargeable), C1778 (lead), C1787 (patient programmer), C1816/C1820/C1822 for generator variants; include exact device HCPCS when known.
Denial Risk
DBS for epilepsy: potential denial triggers
DBS for epilepsy may be denied when patient does not meet age, seizure type, or seizure‑frequency criteria, or when medication‑resistance and surgical candidacy requirements are not met. Pediatric patients (<18 years) or those without focal seizures may be excluded for FDA‑labeled ANT DBS.
Confirm age criteria (FDA ANT indication: ≥18 years) when requesting ANT DBS for epilepsy.
Document focal (partial‑onset) seizure phenotype; requests for generalized epilepsy should include rationale and evidence.
Provide seizure frequency documentation (e.g., ≥6 focal seizures/month where applicable) and AED trial history (≥3 failed AEDs) to avoid denial.
Denial Risk
Contraindications and denial risk
Contraindications that may trigger denial include patients who are poor surgical candidates due to unstable medical comorbidities, presence of cardiac pacemakers that preclude safe implantation, need for repeated MRI incompatible with device use, dementia interfering with cooperation, or very recent botulinum toxin injections for movement disorders.
Document surgical risk assessment and any cardiac devices (e.g., pacemaker) present.
Note dementia or cognitive impairment that may limit cooperation with postoperative programming and follow‑up.
Exclude recent botulinum toxin injections within 6 months for movement disorder implants unless clinically justified.
Note
Evidence‑based selection requirement
Evidence‑based selection is expected when authorizing DBS. Prior authorization reviews prioritize RCTs and comparative prospective trials for efficacy evidence; in their absence, high‑quality prospective observational studies and long‑term single‑arm data may inform decisions. Heterogeneous targets and small sample sizes reduce confidence in benefit.
Ensure indication is supported by higher‑level evidence where available (e.g., RCTs for PD, SANTE trial for ANT epilepsy).
If evidence is limited or mixed for a specific target/indication, document rationale and any multidisciplinary consensus or enrollment in research/registry.
Note
Data completeness affects demonstrated benefit
Data completeness affects demonstrated benefit. Incomplete reporting of primary efficacy or safety endpoints, high loss to follow‑up, or underreporting of device‑related adverse events may limit the ability to establish net health benefit and affect authorization decisions.
Provide complete pre‑ and post‑implant outcome data where available (seizure diaries, standardized rating scales, adverse events).
If relying on registry or single‑arm data, include follow‑up duration and loss‑to‑follow‑up rates.
Note
Underpowered / non‑significant trials may affect coverage
Underpowered or non‑significant RCTs and early trial terminations for futility are potential reasons to question effectiveness for a given indication. Prior authorization reviewers will consider trial power, sample size, and whether primary endpoints were met when assessing requests.
When the supporting RCT was underpowered or failed to meet primary endpoints, include supplemental evidence (longer follow‑up, observational cohorts) and expert rationale.
Document whether trials were stopped early for futility and how that affects expected benefit for the individual patient.
Note
DBS considered for individuals outside standard drug‑resistant definitions
DBS may be considered for individuals who do not meet the definition of drug‑resistant epilepsy in limited or research contexts, but routine coverage is generally reserved for those meeting established drug‑resistant criteria and other eligibility requirements.
For patients who do not meet standard drug‑resistant definitions, specify if treatment is proposed within a research protocol or with special governance.
Document rationale for deviation from standard criteria and supporting multidisciplinary assessment.
Denial Risk
Safety and uncertain benefit may trigger denial
Safety concerns and uncertain net benefit can trigger denials. High rates of serious adverse events, unclear long‑term benefit, or unfavorable risk–benefit ratios for a specific target or indication should be clearly addressed in the prior authorization.
Provide individual risk assessment considering reported rates of serious adverse events in relevant studies.
Include plan for postoperative monitoring and management of device‑ or surgery‑related complications.
Denial Risk
Evidence limitations may lead to denial
Evidence limitations (small sample sizes, heterogeneous targets, inconsistent trial results) may lead to authorization denial for some indications. For indications where literature does not support DBS (e.g., MS tremor) or where RCT evidence is lacking, include justification or research enrollment details.
If requesting DBS for indications with limited evidence, attach multidisciplinary review notes, patient‑specific rationale, and any registry or research protocol enrollment.
Highlight if key trials were small, heterogenous, or terminated for futility.
Denial Risk
Potential denial triggers to address in requests
Potential denial triggers include trials targeting certain brain regions that failed to show effectiveness, RCTs terminated for futility, and high rates of serious adverse events in published studies. Prior authorization should proactively address these limitations.
If supporting literature includes negative or terminated trials, provide clinician rationale for why the patient may still benefit.
Document prior multidisciplinary review, alternative therapies attempted, and informed consent detailing uncertain benefit.
Note
Limited evidence for many indications
Evidence is limited for many investigational indications; many studies are at high risk of bias. Prior authorization should reflect the current evidence state and, for investigational uses, explain whether treatment is part of approved research or registries.
For investigational indications, provide research protocol identifiers, IRB approval, or registry enrollment when applicable.
If no research context exists, explain why off‑label DBS is clinically warranted for this patient.
Denial Risk
Specific indications not supported by literature
Literature does not currently support DBS for certain indications (e.g., MS tremor). Requests for these indications should include compelling, patient‑specific justification and evidence of exhaustion of standard therapies; otherwise they may be denied.
Indicate prior therapies attempted for MS tremor or other low‑evidence indications and why alternatives were not suitable.
Attach specialist consultation and objective measures of disability if requesting DBS for indications with negative or absent evidence.
Prior Authorization
Research / governance requirement for epilepsy DBS
Research and special governance are expected for epilepsy DBS where guidance recommends it. When applicable, prior authorization should document participation in approved research, registry enrollment, or special clinical governance, including consent and audit plans.
Provide documentation of special arrangements for clinical governance, consent, audit, or research when requested by guidance (e.g., NICE recommendations for ANT DBS).
Include registry or study identifiers when the procedure is performed under research oversight.
Billing Rule
Coding mismatch risk
Coding mismatch risk: claims or prior authorizations that lack specific CPT procedure codes for stereotactic implantation, pulse generator insertion/replacement, lead counts, or programming services may be problematic. Ensure perioperative and programming services are coded and documented appropriately.
Supply operative details (use of microelectrode recording, number of arrays/leads, unilateral vs bilateral) to select correct CPT codes (61863–61886 series).
Include programming time and services to support CPT 95970, 95983, 95984 as appropriate.
Provide device HCPCS codes when available to align supply/device claims.
Note
No single explicit authorization/denial rule — provide complete documentation
No explicit universal authorization or denial triggers are listed; determinations rely on documentation of indication, evidence, prior therapy failures, surgical candidacy, and alignment with guideline or regulatory criteria. Thorough prior authorization submissions reduce risk of delays or denials.
Provide complete clinical records, outcome measures, prior treatment history, and multidisciplinary notes where relevant.
If coverage is requested outside standard criteria, include detailed justification and research/governance documentation where applicable.
Documentation Required
Document prior medication responsiveness and disease duration
Documentation should support prior medication responsiveness and disease duration where required by indication (e.g., levodopa response and PD disease duration, duration of antidepressant trials for TRD).
For PD, include documentation of prior levodopa response and duration of PD (e.g., ≥4 years when required).
For treatment‑resistant depression, document number and duration of failed antidepressant trials and prior ECT/psychotherapy as applicable.
Documentation Required
Required clinical documentation
Required clinical documentation includes diagnosis, baseline severity, objective outcome measures, prior treatment history with dates and responses, and surgical candidacy assessment. For epilepsy, include detailed seizure diaries and AED trial records.
Attach baseline and recent severity scores (e.g., UPDRS, YGTSS, Burke‑Fahn‑Marsden, QOLIE‑31) and objective measures of functional impact.
Include detailed prior therapy chronology: medications, doses, durations, response, botulinum toxin dates, VNS status, prior surgeries and outcomes.
Documentation Required
Required clinical and device documentation for aDBS
Required clinical and device documentation for adaptive DBS requests should include device configuration, aDBS mode settings, algorithms used, patient‑reported metrics, and programming logs in addition to standard clinical documentation.
Provide device programming reports, LFP signal documentation (for aDBS), and logs of adaptive algorithm modes and parameter changes.
Include patient‑reported 'On' time and dyskinesia diaries or equivalents used in trial assessments (e.g., Parkinson's Disease Home Diary).
Documentation Required
Epilepsy candidacy documentation
Epilepsy candidacy documentation should show that patients meet definitions of drug‑resistant epilepsy, have focal onset seizures appropriate for the targeted nucleus, have failed adequate AED trials, and are not candidates for resective surgery or have failed resective surgery.
Document ILAE definition application (failure of ≥2 adequate AED trials) and, for Medtronic ANT indication, failure of ≥3 AEDs and average ≥6 focal seizures/month where applicable.
Provide preoperative epilepsy workup (EEG, imaging, surgical evaluations) showing nonresectable focus or failed prior resections.
Documentation Required
Document prior therapeutic failures
Document prior treatment failures thoroughly. For movement disorders, show adequate pharmacologic therapy trials and consideration of less invasive options; for epilepsy, list AEDs tried and responses; for psychiatric indications, document multiple antidepressant/therapy trials and ECT where applicable.
List specific medications, doses, durations, and objective response for each prior trial.
For DBS considered after other interventional options (e.g., VNS, ketogenic diet, botulinum toxin, neuroablative procedures), document attempts and outcomes.
Billing Rule
Required coding documentation
Required coding documentation: use appropriate CPT, HCPCS, revenue, and ICD diagnosis codes that match the performed procedures and devices. Ensure programming and analysis services are supported by time and service documentation.
Map operative steps to CPT codes (implantation, generator insertion/replacement, lead revisions) and list additional array codes if multiple leads were implanted.
Support CPT 95970/95983/95984 with programming time and device analysis notes.
Include HCPCS device supply codes where applicable to support device charges.
Use in policyMotor portion used to define eligibility (motor UPDRS off-med score referenced for PD DBS criteria)
Essential Tremor — definition
DefinitionUncontrolled shaking or trembling, usually of the hands or arms, that worsens with movement and is not attributable to an underlying disease like Parkinson disease
Typical distributionUsually affects one or both hands/arms and worsens with purposeful movement
Context for DBSConsidered for DBS when tremor is disabling and medically unresponsive to medications
DefinitionMovement disorder characterized by involuntary muscle contractions; primary (idiopathic) dystonia is present when dystonia is the only sign after secondary causes are excluded
Clinical patternsCan be focal, segmental, multifocal, hemidystonia, or generalized; may have childhood or adult onset
DBS contextPrimary dystonia eligible for GPi or STN DBS when drug‑refractory and causing significant disability
Focal seizures — definition
DefinitionFocal seizures originate in one brain area (part of one lobe/hemisphere) and may occur with or without impairment of consciousness
Clinical variantsFocal seizures without loss of consciousness (simple focal) and with impaired awareness (complex focal)
Relevance to DBSANT DBS indication targets focal (partial‑onset) seizures
Generalized seizures — definition
DefinitionGeneralized seizures affect both cerebral hemispheres from onset and produce loss of consciousness
Major typesIncludes generalized tonic‑clonic, myoclonic, atonic, and absence seizures
Contrast with focal seizuresANT DBS indication is for focal (partial‑onset) seizures rather than primary generalized seizures
Adaptive deep brain stimulation (aDBS) — definition
DefinitionAdaptive deep brain stimulation (aDBS) is an optional programming feature that adapts stimulation parameters in response to sensed neural signals (e.g., local field potentials) to adjust stimulation in real time
Device contextaDBS is offered as an option in existing Medtronic systems (e.g., Percept PC) and tested in randomized trials (ADAPT‑PD)
ModesAlgorithms include single‑ and dual‑threshold modes that adjust stimulation amplitude based on detected LFP fluctuations
Indication-specific targetsThalamus for essential tremor; GPi or STN for Parkinson disease and primary dystonia; anterior nucleus of thalamus for epilepsy
Clinical selectionTarget selection individualized based on symptom profile, goals (e.g., medication reduction, dyskinesia control), and evidence
Adaptive deep brain stimulation (aDBS) — definition (alternate)
Definition (alternate wording)aDBS adjusts stimulation amplitude in real time based on detected local field potential (LFP) fluctuations using single‑ or dual‑threshold algorithms; evaluated in randomized crossover trials in PD
Intended benefitAims to maintain efficacy while potentially reducing stimulation‑related adverse effects and energy use
Trial evidenceADAPT‑PD assessed feasibility and predefined success endpoints comparing aDBS to continuous DBS
Primary dystonia — definition
Primary dystonia definition (alternate)A movement disorder where dystonia is the sole clinical manifestation and secondary causes have been excluded; can be focal, segmental, multifocal, or generalized
Pediatric contextPediatric cases studied with benefit; policy specifies minimum age ≥7 years for coverage
DBS roleDBS offers a reversible alternative to neurodestructive procedures for chronic refractory primary dystonia
GPi — definition
GPi — abbreviation and roleGPi = Globus pallidus internus; a common DBS target particularly for dystonia and for treating certain Parkinson disease motor complications
Clinical contextGPi stimulation has randomized trial evidence supporting improvement in dystonia severity and disability measures
Surgical noteGPi DBS may be performed unilaterally or bilaterally depending on clinical distribution
Drug-resistant epilepsy — definition
ILAE-based definitionDrug‑resistant epilepsy: failure of adequate trials of 2 tolerated, appropriately chosen and administered antiepileptic drugs to achieve seizure freedom (ILAE consensus)
Trial vs definitionMajor device trials and labeling often required failure of ≥3 AEDs for inclusion, though ILAE definition requires ≥2 failures
Implication for candidacyDocumentation should show prior AED trials and rationale for non‑resectability when considering DBS
Drug‑resistant epilepsy — definition (alternate)
Alternative phrasingDrug‑resistant epilepsy is defined as failure of adequate trials of 2 tolerated, appropriately chosen and administered AEDs; device trials often enrolled patients refractory to ≥3 AEDs
ReferenceILAE consensus definition cited in policy (Kwan et al.)
Clinical useUsed to determine eligibility and document prior therapy in prior authorization requests
Responder — definition (seizure reduction ≥50%)
Responder (seizure reduction)Responder is a patient experiencing a reduction of 50% or more in seizure frequency
Use in trials≥50% reduction commonly used as primary responder threshold in epilepsy DBS and other neuromodulation trials
Outcome measurementResponder status typically assessed by patient seizure diaries and study electrographic monitoring where available
Responder — definition (study use, seizure/YGTSS)
Responder (study definitions)In epilepsy and Tourette studies, responder often defined as ≥50% seizure reduction or substantial reduction in YGTSS for tics; studies use these thresholds for reporting
YGTSS contextYGTSS used to quantify tic severity and define responder categories in Tourette trials
OCD/Tourette parallelResponder thresholds vary by indication (e.g., ≥35% Y‑BOCS for OCD; ≥50% seizure reduction for epilepsy)
YGTSS — definition and scoring
YGTSS descriptionYale Global Tic Severity Scale (YGTSS) is a clinician‑rated scale with total score 0–100; lower scores indicate less severe tics
SubscalesIncludes motor tic and vocal tic subscales and measures impairment
Use in trialsUsed as primary outcome measure in Tourette DBS studies to quantify tic severity and response
Cluster headache (episodic vs chronic) — definition
Cluster headache classificationCluster headache (trigeminal autonomic cephalalgia) can be episodic or chronic; attacks last 15–180 minutes and meet ICHD criteria
Episodic vs chronicEpisodic: cluster periods separated by pain‑free remissions ≥3 months; Chronic: ≥1 year without remission or remission <3 months
Typical onsetAge of onset generally 20–40 years, more common in men
Response (depression/OCD) — definition
Response (depression/OCD)Response commonly defined as ≥50% reduction in validated depression rating scales (HDRS/MADRS) and ≥35% reduction in Y‑BOCS for OCD
Remission vs responseRemission requires achieving a specific threshold on rating scales; response denotes substantial symptom reduction but not necessarily remission
Use in studiesResponse definitions guide trial endpoints and prior authorization documentation for psychiatric indications
Remission (depression/OCD) — definition
Remission (depression/OCD)Remission is defined by achieving a threshold score on validated scales (e.g., HDRS/MADRS for depression); OCD remission not uniformly defined but lower Y‑BOCS corresponds to clinical remission
Clinical implicationRemission is a more stringent endpoint than response and may be used in long‑term outcome reporting
DocumentationScale scores at baseline and follow‑up should be documented where used in trials or clinical decision making
Responder (OCD) — definition (≥35% Y-BOCS)
Responder (OCD) thresholdResponder commonly defined as ≥35% reduction in Yale‑Brown Obsessive Compulsive Scale (Y‑BOCS) score in OCD studies
Partial responderPartial response often defined as 25–35% reduction in Y‑BOCS
Use in guidanceResponder thresholds inform eligibility and expected benefit in trial interpretation
Severe OCD — definition (Y-BOCS ≥24)
Severe OCD definitionY‑BOCS score ≥24 (of 40) indicates severe obsessive‑compulsive disorder
Clinical implicationSeverity thresholds used to select candidates for invasive therapies in refractory cases
DocumentationBaseline Y‑BOCS should be documented when considering DBS for OCD
DBS targets — common targets list
Common DBS targets listSTN, GPi, thalamic nuclei (e.g., VIM), anterior nucleus of thalamus (ANT), nucleus accumbens/BNST, anterior limb of internal capsule
Target–indication mappingSTN/GPi for Parkinson disease; VIM thalamus for essential tremor; GPi for dystonia; ANT for epilepsy
Target selection noteChoice individualized based on symptom profile, goals (medication reduction, dyskinesia control), and evidence base
Medically refractory — definition
Medically refractory definitionFailure to respond adequately to appropriate medical therapy (examples: tremor unresponsive to medications; epilepsy after failure of ≥2 appropriately dosed AEDs)
ApplicationUsed to determine candidacy for DBS across indications where standard therapies have failed
DocumentationPrior therapy attempts and durations should be documented for prior authorization
ILAE referencePolicy references ILAE consensus (Kwan et al.) for definition of drug‑resistant epilepsy
Definition summaryFailure of adequate trials of 2 tolerated, appropriately chosen and administered AEDs to achieve seizure freedom
Use in policyCited to support epilepsy candidacy and documentation requirements
FDA SSED — regulatory documents cited as evidence
FDA SSED citedMedtronic Summary of Safety and Effectiveness Data (SSED) for DBS systems (Activa, Percept, SenSight) cited as regulatory evidence
Regulatory link to epilepsy labelingMedtronic DBS System for Epilepsy FDA approval (2018) and SANTE trial data referenced in device labeling and policy
Use in evidence baseSSED documents used to summarize device effectiveness and safety data within the policy