Latest Review Date: May 2024

Category:  Surgery                                                    

POLICY:

Unilateral deep brain stimulation of the thalamus may be considered medically necessary in individuals with disabling, medically unresponsive tremor due to essential tremor or Parkinson disease.

Disabling, medically unresponsive tremor is defined as all of the following:

• Tremor causing significant limitation in daily activities
• Inadequate control by maximal dosage of medication for at least three months before implant

Bilateral deep brain stimulation of the thalamus may be considered medically necessary in individuals with disabling, medically unresponsive tremor in both upper limbs due to essential tremor or Parkinson disease.

Unilateral or bilateral deep brain stimulation of the globus pallidus or subthalamic nucleus may be considered medically necessary in the following individuals:

• Those with Parkinson disease and ALL of the following:
  • A good response to levodopa; AND
  • Motor complications not controlled by pharmacologic therapy; and
  • One of the following:
    • A minimum score of 30 points on the motor portion of the Unified Parkinson Disease Rating Scale when the individual has been without medication for approximately 12 hours OR
    • Parkinson disease for at least 4 years.
• Individuals older than 7 years with chronic, intractable (drug-refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).

Deep brain stimulation for other movement disorders, including but not limited to post-traumatic dyskinesia, and tardive dyskinesia, is considered investigational.

Deep brain stimulation for the treatment of chronic cluster headaches is considered investigational.

Deep brain stimulation for the treatment of other psychiatric or neurologic disorders, including but not limited to Tourette syndrome, depression, obsessive compulsive disorder, anorexia nervosa, alcohol addiction, chronic pain, multiple sclerosis, Alzheimer disease, and epilepsy, is considered investigational.

Motor Cortex Stimulation

Motor cortex stimulation for any indication is considered investigational.

POLICY GUIDELINES:

Contraindications to deep brain stimulation include:

• Individuals who are not good surgical risks because of unstable medical problems or because of the presence of a cardiac pacemaker
• Individuals who have medical conditions that require repeated magnetic resonance imaging (MRI)
• Individuals who have dementia that may interfere with the ability to cooperate
• Individuals who have had botulinum toxin injections within the last 6 months

DESCRIPTION OF PROCEDURE OR SERVICE:

Deep brain stimulation (DBS) involves the stereotactic placement of an electrode into the brain (i.e., hypothalamus, thalamus, globus pallidus, or subthalamic nucleus). DBS is used as an alternative to permanent neuroablative procedures for control of essential tremor (ET) and Parkinson's disease (PD). DBS is also being evaluated for the treatment of a variety of other neurologic and psychiatric disorders.

Deep Brain Stimulation

DBS involves the stereotactic placement of an electrode into the brain (i.e., hypothalamus, thalamus, globus pallidus, or subthalamic nucleus). The electrode is initially attached to a temporary transcutaneous cable for short-term stimulation to validate treatment effectiveness. Several days later, the individual returns to surgery for permanent subcutaneous implantation of the cable and a radiofrequency-coupled or battery-powered programmable stimulator. The electrode is typically implanted unilaterally on the side corresponding to the most severe symptoms. However, the use of bilateral stimulation using two electrode arrays has also been investigated in individuals with bilateral, severe symptoms. After implantation, noninvasive programming of the neurostimulator can be adjusted to the individual's symptoms. This feature may be important for individuals with PD, whose disease may progress over time, requiring different neurostimulation parameters. Setting the optimal neurostimulation parameters may involve the balance between optimal symptom control and appearance of side effects of neurostimulation, such as dysarthria, disequilibrium, or involuntary movements.

Motor Cortex Stimulation

Motor cortex stimulation (MCS), also referred to as cerebral cortex stimulation or extradural motor cortex stimulation (EMCS), is primarily utilized for the treatment of refractory neuropathic pain and involves implantation of epidural electrodes into the cerebral cortex.

A temporary placement of a MCS device is completed to determine if the device will relieve pain consistently over the course of 3–14 days and produce a reduction in pain by at least 50%. If the individual reports such relief, a permanent placement occurs connecting the electrodes and implanting the programmable device just underneath the skin proximate to the collarbone.

KEY POINTS:

This policy was updated with a literature review of the PubMed database through February 22, 2024.

Summary of Evidence

For individuals who have essential tremor or tremor in Parkinson disease who receive deep brain stimulation of the thalamus, the evidence includes a systematic review and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The systematic review (a TEC Assessment) concluded that there was sufficient evidence that deep brain stimulation of the thalamus results in clinically significant tremor suppression and that outcomes after deep brain stimulation were at least as good as thalamotomy. Subsequent studies reporting long-term follow-up have supported the conclusions of the TEC Assessment and found that tremors were effectively controlled 5 to 6 years after deep brain stimulation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have symptoms (e.g., speech, motor fluctuations) associated with Parkinson disease (advanced or >4 years in duration with early motor symptoms) who receive deep brain stimulation of the globus pallidus interna or subthalamic nucleus, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. One of the systematic reviews (a TEC Assessment) concluded that studies evaluating deep brain stimulation of the globus pallidus interna or subthalamic nucleus have consistently demonstrated clinically significant improvements in outcomes (e.g., neurologic function). Other systematic reviews have also found significantly better outcomes after deep brain stimulation than after a control intervention. An RCT in patients with levodopa-responsive Parkinson disease of at least 4 years in duration and uncontrolled motor symptoms found that quality of life at 2 years was significantly higher when deep brain stimulation was provided in addition to medical therapy. Meta-analyses of RCTs comparing deep brain stimulation of the globus pallidus interna with deep brain stimulation of the subthalamic nucleus have reported mixed findings and have not shown that one type of stimulation is superior to the other. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have primary dystonia who receive deep brain stimulation of the globus pallidus interna or subthalamic nucleus, the evidence includes systematic reviews, RCTs, and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. A pooled analysis of 24 studies, mainly uncontrolled, found improvements in motor scores and disability scores after 6 months and at last follow-up (mean, 32 months). Both double-blind RCTs found that severity scores improved more after active than after sham stimulation. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have tardive dyskinesia or tardive dystonia who receive deep brain stimulation, the evidence includes an RCT and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The RCT did not report statistically significant improvement in the dystonia severity outcomes or the secondary outcomes related to disability and quality of life, but these may have been underpowered. Additional studies, especially RCTs or other controlled studies, are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have epilepsy who receive deep brain stimulation, the evidence includes systematic reviews, RCTs and many observational studies. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Two RCTs with more than 15 patients were identified. The first RCT (N=110) evaluated anterior thalamic nucleus deep brain stimulation and reported that deep brain stimulation had a positive impact on seizure frequency during some parts of the blinded trial phase, but not others, and a substantial number of adverse events (in >30% of individuals). There were no differences between groups in 50% responder rates, Liverpool Seizure Severity Scale, or Quality of Life in Epilepsy scores. A 7-year open-label follow-up of the RCT included 66% of implanted individuals; reasons for missing data were primarily related to adverse events or dissatisfaction with the device. Reduction in seizure frequency continued to improve during follow-up among the patients who continued follow-up. The second RCT (N=16) showed a benefit with deep brain stimulation. Many observational studies reported fewer seizures compared with baseline, however, without control groups, interpretation of these results is limited. Additional trials are required to determine the impact of deep brain stimulation on individual outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have Tourette syndrome who receive deep brain stimulation, the evidence includes observational studies, RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Two RCTs with 15 or more individuals have been reported. One RCT found differences in severity of Tourette syndrome for active versus sham at 3 months while the other RCT did not. Neither study demonstrated improvements in comorbid symptoms of obsessive-compulsive disorder or depression. Both studies reported high rates of serious adverse events. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have cluster headaches or facial pain who receive deep brain stimulation, the evidence includes a systemic review, randomized crossover study and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. The systematic review included an individual patient data meta-analysis of 34 individuals, showing a significant reduction in pain intensity at 3 months following deep brain stimulation for chronic facial pain; data for follow-up beyond 3 months were not eligible for statistical analysis. In an RCT of 11 individuals with severe, refractory, chronic cluster headache, the between-group difference in response rates did not differ significantly between active and sham stimulation phases. Additional RCTs or controlled studies are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have treatment resistant depression who receive deep brain stimulation, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. A number of case series and several prospective controlled trials evaluating deep brain stimulation have been published. Two RCTs of deep brain stimulation in the subgenual cingulate cortex and ventral striatum/ventral capsule were terminated for futility. Another RCT of stimulation of the same brain area (ventral striatum/ventral capsule) did not find a statistically significant difference between groups in the primary outcome (clinical response), and adverse psychiatric events occurred more frequently in the treatment group than in the control group. More recently, a controlled crossover trial randomized individuals to sham or active stimulation of the anterior limb of the internal capsule after a year of open-label stimulation. There was a greater reduction in symptom scores after active stimulation, but only in individuals who were responders in the open-label phase. Stimulation of the subcallosal (subgenual) cingulate was evaluated in a 2019 sham-controlled within-subject study that found prolonged response in 50% of individuals and remission in 30% of individuals with treatment resistant depression. Deep brain stimulation for individuals with major depressive disorder who have failed all other treatment options is an active area of research, but the brain regions that might prove to be effective for treatment resistant depression have yet to be established. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have obsessive-compulsive disorder who receive deep brain stimulation, the evidence includes meta-analyses of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Among the RCTs on deep brain stimulation for obsessive-compulsive disorder, included in the meta-analyses, only one has reported an outcome of clinical interest (therapeutic response rate), and that trial did not find a statistically significant benefit for deep brain stimulation compared with sham treatment. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have other neurologic or psychiatric disorders who receive deep brain stimulation, the evidence includes a number of nonrandomized studies or RCTs in individuals with multiple sclerosis, chronic pain, or alcohol use disorder. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. One RCT with 10 multiple sclerosis individuals, 2 RCTs in individuals with chronic pain, and 1 RCT in individuals with treatment-refractory alcohol use disorder is insufficient evidence on which to draw conclusions about the efficacy of deep brain stimulation in these populations. Additional trials are required. For individuals who have anorexia nervosa, Alzheimer disease, Huntington disease, or chronic pain who receive deep brain stimulation, the evidence includes case series; RCTs are needed to evaluate the efficacy of deep brain stimulation for these conditions. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Neurology

Essential Tremor

In 2011, the American Academy of Neurology (AAN) updated its guidelines on the treatment of essential tremor, which were reaffirmed in 2022. This update did not change the conclusions and recommendations of the AAN (2005) practice parameters on deep brain stimulation for essential tumor.  The guidelines stated that bilateral deep brain stimulation of the thalamic nucleus may be used to treat medically refractory limb tremor in both upper limbs (level C, possibly effective) but that there were insufficient data on the risk/benefit ratio of bilateral versus unilateral deep brain stimulation in the treatment of limb tremor. There was insufficient evidence to make recommendations on the use of thalamic deep brain stimulation for head or voice tremor (level U, treatment is unproven).

Parkinson Disease

In 2018, the AAN affirmed the guideline developed by the Congress of Neurological Surgeons (see Table 1).

Tourette Syndrome

Guidelines from AAN (2019, reaffirmed 2022) provide recommendations on the assessment for and use of deep brain stimulation in adults with severe, treatment-refractory tics. The AAN notes that individuals with severe Tourette syndrome resistant to medical and behavioral therapy may benefit from deep brain stimulation, but there is no consensus on the optimal brain target. Brain regions that have been stimulated in individuals with Tourette syndrome include the centromedian thalamus, the globus pallidus internus (ventral and dorsal), the globus pallidus externus, the subthalamic nucleus, and the ventral striatum/ventral capsular nucleus accumbens region. The AAN concludes that deep brain stimulation of the anteromedial globus pallidus is possibly more likely than sham stimulation to reduce tic severity.

American Society for Stereotactic and Functional Neurosurgery 

Obsessive-Compulsive Disorder

In 2021, the American Society for Stereotactic and Functional Neurosurgery and the Congress of Neurological Surgeons) updated their 2014 guidelines on deep brain stimulation for obsessive-compulsive disorder. The document concluded that there was a single level I study supporting the use of bilateral subthalamic nucleus deep brain stimulation for medically refractory obsessive-compulsive disorder and a single level II study supporting bilateral nucleus accumbens or bed nucleus of stria terminalis deep brain stimulation for medically refractory obsessive-compulsive disorder. It also concluded that the evidence on unilateral deep brain stimulation was insufficient.

Refractory Epilepsy

In 2022, the American Society for Stereotactic and Functional Neurosurgery published a position statement on deep brain stimulation for medication-refractory epilepsy. Indications for deep brain stimulation include confirmed diagnosis of epilepsy (focal onset seizures with or without generalization), failure to achieve seizure control after 2 or more appropriately dosed seizure medications, seizures with localized onset in a region that cannot be resected or for which surgical resection has failed, or focal-onset seizures with a non-localized or unclear region of onset.

Congress of Neurologic Surgeons

Parkinson Disease

In 2018, evidence-based guidelines from the Congress of Neurologic Surgeons, affirmed by the AAN, compared the efficacy of bi-lateral deep brain stimulation of the subthalamic nucleus and globus pallidus internus for the treatment of individuals with Parkinson disease.

Table 1. Recommendations of the Congress of Neurologic Surgeons for DBS for Parkinson Disease.

Goal	Most Effective Area of Stimulation (subthalamic nucleus or globus pallidus internus)	Level of Evidence
Improving motor symptoms	Subthalamic nucleus or globus pallidus internus are similarly effective	I
Reduction of dopaminergic medication	Subthalamic nucleus	I
Treatment of "on" medication dyskinesias	Globus pallidus internus if reduction of medication is not anticipated	I
Quality of life	No evidence to recommend one over the other	I
Lessen impact of DBS on cognitive decline	Globus pallidus internus	I
Reduce risk of depression	Globus pallidus internus	I
Reduce adverse effects	Insufficient evidence to recommend one over the other	Insufficient

DBS: Deep brain stimulation

National Institute for Health and Care Excellence

The United Kingdom's NICE has published guidance documents on deep brain stimulation, as discussed in the following subsections.

Tremor and Dystonia

In 2006, NICE made the same statement about use of DBS for treatment of tremor and dystonia. Unilateral and bilateral stimulation of structures responsible for modifying movements, such as the thalamus, the globus pallidus and the subthalamic nucleus, which interact functionally with the substantia nigra, are included in both guidance statements. The guidance stated: “Current evidence on the safety and efficacy of deep brain stimulation for tremor and dystonia (excluding Parkinson's disease) appears adequate to support the use of this procedure.”

Refractory Chronic Pain Syndromes (Excluding Headache)

In 2011, guidance from NICE indicated there is evidence that deep brain stimulation for refractory chronic pain (excluding headache) is associated with serious risks. However, the procedure is “efficacious in some patients” refractory to other treatments.” Individuals should be informed that deep brain stimulation may not control their chronic pain symptoms and that possible risks associated with this procedure include the small risk of death.

Intractable Trigeminal Autonomic Cephalgias

The 2011 guidance states that current evidence on the efficacy of DBS for intractable trigeminal autonomic cephalalgias (e.g., cluster headaches) was "limited and inconsistent, and the evidence on safety shows that there are serious but well-known adverse effects."

Refractory Epilepsy

In 2020, guidance from NICE indicated that the evidence on the efficacy and safety of deep brain stimulation for refractory epilepsy (for anterior thalamic targets) was limited in both quantity and quality, and "this procedure should only be used with special arrangements for clinical governance, consent, and audit or research". For targets other than the anterior thalamus, NICE recommends, "this procedure should only be used in the context of research."

Parkinson Disease

In 2003, NICE stated that current evidence on the safety and efficacy of DBS for treatment of PD appears adequate to support the use of the procedure. The guidance noted that DBS should only be offered when Parkinson disease is refractory to best medical treatment.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Activa Tremor Control System, deep brain stimulation, dystonia, essential tremor, Parkinson disease, Reclaim™ DBS therapy, obsessive compulsive disorder (OCD), Vercise ™, chronic cluster headaches, Brio Neurostimulation System, Infinity DBS device, epilepsy, Motor Cortex Stimulation, MCS, cerebral cortex stimulation, CCS, extradural motor cortex stimulation (EMCS), Percept PC DBS System, Vercise Genus DBS System, Medtronic DBS System

APPROVED BY GOVERNING BODIES:

In 1997, the Activa® Tremor Control System (Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the pre-market approval process for deep brain stimulation. The Activa Tremor Control System consists of an implantable neurostimulator, a deep brain stimulator lead, an extension that connects the lead to the power source, a console programmer, a software cartridge to set electrical parameters for stimulation, and a patient control magnet, which allows the patient to turn the neurostimulator on and off, or change between high and low settings.

The FDA-labeled indications for Activa were originally limited to unilateral implantation for the treatment of tremor, but the indications have evolved over time. In 2002, the FDA labeled indications were expanded to include bilateral implantation as a treatment to decrease the symptoms of advanced Parkinson disease not controlled by medication. In 2003, the labeled indications were further expanded to include “…unilateral or bilateral stimulation of the internal globus pallidus or subthalamic nucleus to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients 7 years of age or above.” In 2018, the deep brain stimulation system received an expanded indication as an adjunctive therapy for epilepsy (P960009-S219). Other deep brain stimulation systems are described in Table 2.

There are currently no devices approved by the FDA for motor cortex stimulation.

Table 2. Deep Brain Stimulation Systems

System	Manufacturer	Features	PMA or HDE	Approval Date	Indications
Activa® Deep Brain Stimulation Therapy System	Medtronic		P96009	1997	Unilateral or bilateral stimulation of the internal globus pallidus or subthalamic nucleus for symptoms of Parkinson disease or primary dystonia
Reclaim® DBS Therapy for Obsessive Compulsive Disorder	Medtronic	Approved for OCD	H050003	2009	Bilateral stimulation of the anterior limb of the internal capsule for severe obsessive-compulsive disorder
Brio Neurostimulation System	St. Jude Medical	NHL	P140009	2015	Parkinsonian tremor (subthalamic nucleus) and essential tremor (thalamus)
Infinity DBS	Abbott Medical/St. Jude Medical	PJS	P140009	2016	Parkinsonian tremor
Vercise DBS System	Boston Scientific	NHL	P150031	2017	Moderate-to-advanced levodopa-responsive PD inadequately controlled with medication alone
Medtronic DBS System for Epilepsy	Medtronic	MBX	P960009-S219	2018	Expanded indication for epilepsy with bilateral stimulation of the anterior nucleus of the thalamus
Percept PC Deep Brain Stimulation	Medtronic	MHY	P960009-S	2020	Records brain signals while delivering therapy for PD or primary dystonia
Vercise Genus DBS System	Boston Scientific	NHL	P150031-S034	2021	Stimulation of the subthalamic nucleus and globus pallidus for PD
SenSight Directional Lead System	Medtronic	MHY	P960009	2021	Unilateral or bilateral stimulation for PD, tremor, dystonia, and epilepsy

DBS: deep brain stimulation; HDE: humanitarian device exemption; PD: Parkinson disease; PMA: premarket approval

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:

Implantation of Electrodes:

61850	Twist drill or burr hole for implantation of neurostimulator electrodes, cortical
*61863	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
*61864	; as above, but with each additional array
*61867	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
*61868	; as above, but with each additional array.

*The above four codes have the option of the implantation of electrodes using microelectrode recording or not.  In addition, if the individual is undergoing bilateral implantation of electrodes, one of the “each additional array” codes may be used. In some instances, individuals undergo bilateral implantation in a staged procedure.

Implantation of Pulse Generator:

61885	Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array; OR
61886	; as above, but with connection to two or more electrode arrays

Electronic Analysis:

95970	Electronic analysis of implanted neurostimulator pulse generator system (e.g. rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (i.e. cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without programming
95983	Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain neurostimulator pulse generator/transmitter programming, first 15 minutes face-to-face time with physician or other qualified health care professional
95984	Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain neurostimulator pulse generator/transmitter programming, each additional 15 minutes face-to-face time with physician or other qualified health care professional (List separately in addition to code for primary procedure)

Neurostimulator analysis and programming is classified as either simple (95970) or complex (95983-84).  CPT codes 95983 and 95984 are time based. Simple neurostimulators are defined as those affecting three or fewer neurostimulatory parameters (e.g., pulse amplitude, duration, and frequency, number of electrode contacts) while a complex device affects more than three parameters.  In the setting of deep brain stimulation for tremor control, it is anticipated that the neuro-programming and analysis would be classified as simple.  However, deep brain stimulation of the globus pallidus and subthalamic nucleus stimulation requires intraoperative monitoring of more than one clinical feature, (i.e., rigidity, dyskinesia, and tremor) and the neuro-programming would probably be classified as complex.

Over time, individuals may undergo several sessions of electronic analysis and programming to find the optimal programming parameters. CPT codes 95970, 95983, and 95984, described here, may be used.

HCPCS:              

L8680	Implantable neurostimulator electrode, each
L8685	Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686	Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension
L8687	Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688	Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension

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33. Jost ST, Aloui S, Evans J, et al. Neurostimulation for Advanced Parkinson Disease and Quality of Life at 5 Years: A Nonrandomized Controlled Trial. JAMA Netw Open. Jan 02 2024; 7(1): e2352177.
34. Kefalopoulou Z, Zrinzo L, Jahanshahi M, et al. Bilateral globus pallidus stimulation for severe Tourette's syndrome: a double-blind, randomised crossover trial. Lancet Neurol. Jun 2015; 14(6):595-605.
35. Kim SH, Lim SC, Kim J, et al. Long-term follow-up of anterior thalamic deep brain stimulation in epilepsy: A 11-year, single center experience. Seizure. Nov 2017; 52:154-161.
36. Kisely S, Hall K, Siskind D, et al. Deep brain stimulation for obsessive-compulsive disorder: a systematic review and meta-analysis. Psychol Med. Dec 2014; 44(16):3533-3542. 
37. Kleiner-Fisman G, Herzog J, Fisman DN, et al. Subthalamic nucleus deep brain stimulation: summary and meta-analysis of outcomes. Mov Disord. Jun 2006; 21 Suppl 14: S290-304
38. Koyama H, Mure H, Morigaki R, et al. Long-Term Follow-Up of 12 Patients Treated with Bilateral Pallidal Stimulation for Tardive Dystonia. Life (Basel). May 24 2021; 11(6).
39. Kupsch A, Benecke R, Muller J, et al. Deep-Brain Stimulation for Dystonia Study Group. Pallidal deep-brain stimulation in primary generalized or segmental dystonia. N Engl J Med. Nov 09 2006; 355(19):1978-90. 
40. Kwan P, Arzimanoglou A, Berg AT, et al. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. Jun 2010; 51(6): 1069-77.
41. Li MCH, Cook MJ. Deep brain stimulation for drug-resistant epilepsy. Epilepsia. Feb 2018; 59(2):273-290.
42. Mandat V, Zdunek PR, Krolicki B, et al. Periaqueductal/periventricular gray deep brain stimulation for the treatment of neuropathic facial pain. Front Neurol. 2023; 14: 1239092.
43. Mar-Barrutia L, Real E, Segalas C, et al. Deep brain stimulation for obsessive-compulsive disorder: A systematic review of worldwide experience after 20 years. World J Psychiatry. Sep 19 2021; 11(9): 659-680.
44. Martinez-Ramirez D, Jimenez-Shahed J, Leckman JF, et al. Efficacy and Safety of Deep Brain Stimulation in Tourette Syndrome: The International Tourette Syndrome Deep Brain Stimulation Public Database and Registry. JAMA Neurol. Mar 01 2018; 75(3): 353-359.
45. Moro E, LeReun C, Krauss JK, et al. Efficacy of pallidal stimulation in isolated dystonia: a systematic review and meta-analysis. Eur J Neurol. Apr 2017; 24(4):552-560.
46. National Institute for Health and Care Excellence (NICE). Deep brain stimulation for refractory epilepsy [IPG416]. 2020; www.nice.org.uk/guidance/IPG678/chapter/1-Recommendations.
47. National Institute for Clinical Excellence (NICE). Interventional Procedure Guidance 19. Deep brain stimulation for Parkinson’s disease. 2003; www.nice.org.uk/guidance/ipg19.
48. National Institute for Clinical Excellence (NICE). Interventional Procedure Guidance 19. Deep brain stimulation for tremor and dystonia (excluding Parkinson’s disease). 2006; www.nice.org.uk/guidance/ipg188.
49. National Institute for Clinical Excellence (NICE). Interventional Procedure Guidance 382. Deep brain stimulation for refractory chronic pain syndromes (excluding headache) 2011;www.guidance.nice.org.uk/IPG382. 
50. National Institute for Clinical Excellence (NICE). Interventional Procedure Guidance 381. Deep brain stimulation for intractable trigeminal autonomic cephalalgias. 2011; www.nice.org.uk/IPG381.
51. Pahwa R, Lyons KE, Wilkinson SB et al. Long-term evaluation of deep brain stimulation of the thalamus. J Neurosurg 2006; 104(4):506-12. 
52. Peltola J, Colon AJ, Pimentel J, et al. Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Drug-Resistant Epilepsy in the MORE Multicenter Patient Registry. Neurology. May 02 2023; 100(18): e1852-e1865.
53. Perestelo-Perez L, Rivero-Santana A, Perez-Ramos J, et al. Deep brain stimulation in Parkinson's disease: meta-analysis of randomized controlled trials. J Neurol. Nov 2014; 261(11):2051-2060.
54. Piedad JC, Rickards HE, Cavanna AE. What patients with Gilles de la Tourette syndrome should be treated with deep brain stimulation and what is the best target? Neurosurgery. Jul 2012; 71(1):173-192.
55. Pouclet-Courtemanche H, Rouaud T, Thobois S, et al. Long-term efficacy and tolerability of bilateral pallidal stimulation to treat tardive dyskinesia. Neurology. Feb 16 2016; 86(7):651-659.
56. Pringsheim T, Okun MS, Muller-Vahl K, et al. Practice guideline recommendations summary: Treatment of tics in people with Tourette syndrome and chronic tic disorders. Neurology. May 07 2019; 92(19): 896-906.
57. Putzke JD, Uitti RJ, Obwegeser AA et al. Bilateral thalamic deep brain stimulation: midline tremor control. J Neurol Neurosurg Psychiatry 2005; 76(5):684-90. 
58. Qassim H, Zhao Y, Ströbel A, et al. Deep Brain Stimulation for Chronic Facial Pain: An Individual Participant Data (IPD) Meta-Analysis. Brain Sci. Mar 14 2023; 13(3).
59. Raviv N, Staudt MD, Rock AK, et al. A Systematic Review of Deep Brain Stimulation Targets for Obsessive Compulsive Disorder. Neurosurgery. Nov 16 2020; 87(6): 1098-1110.
60. Rodrigues FB, Duarte GS, Prescott D, et al.Deep brain stimulation for dystonia. Cochrane Database Syst Rev. Jan 10 2019; 1 (1): CD012405.
61. Rughani A, Schwalb JM, Sidiropoulos C, et al. Congress of Neurological Surgeons Systematic Review and Evidence-Based Guideline on Subthalamic Nucleus and Globus Pallidus Internus Deep Brain Stimulation for the Treatment of Patients With Parkinson's Disease: Executive Summary. Neurosurgery. Jun 01 2018; 82(6): 753-756. 
62. Sako W, Miyazaki Y, Izumi Y, et al. Which target is best for patients with Parkinson's disease? A meta-analysis of pallidal and subthalamic stimulation. J Neurol Neurosurg Psychiatry. Sep 2014; 85(9):982-986.
63. Salanova V, Witt T, Worth R, et al. Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy. Neurology. Mar 10 2015; 84(10):1017-1025.
64. Schnitzler A, Mir P, Brodsky MA, et al. Directional Deep Brain Stimulation for Parkinson's Disease: Results of an International CrossoverStudy With Randomized, Double-Blind Primary Endpoint. Neuromodulation. Aug 2022; 25(6): 817-828.
65. Schrock LE, Mink JW, Woods DW, et al. Tourette syndrome deep brain stimulation: a review and updated recommendations. Mov Disord. Apr 2015; 30(4):448-471.
66. Schuepbach WM, Rau J, Knudsen K, et al. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. Feb 14 2013; 368(7):610-622. 
67. Schuurman PR, Bosch DA, Merkus MP, et al. Long-term follow-up of thalamic stimulation versus thalamotomy for tremor suppression. Mov Disord. Jun 15 2008; 23(8): 1146-53
68. Servello D, Zekaj E, Saleh C, et al. 16 years of Deep Brain Stimulation in Tourette's Syndrome: a critical review. J Neurosurg Sci. Jan 20 2016.
69. Shaffer A, Naik A, Bederson M, et al. Efficacy of deep brain stimulation for the treatment of anorexia nervosa: a systematic review andnetwork meta-analysis of patient-level data. Neurosurg Focus. Feb 2023; 54(2): E5.
70. Sobstyl M, Kupryjaniuk A, Prokopienko M, et al. Subcallosal Cingulate Cortex Deep Brain Stimulation for Treatment-Resistant Depression: A Systematic Review. Front Neurol. 2022; 13: 780481.
71. Sprengers M, Vonck, K,  Carrette E, et al. Deep brain and cortical stimulation for epilepsy. Cochrane Database Syst Rev, Jul 18 2017; 7 (7):CD008497.
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POLICY HISTORY:

Medical Policy Group, January 2009 (3)

Medical Policy Administration Committee, February 2009

Available for comment February 6-March 23, 2009

Medical Policy Group, June 2011; Updated Description, Key Points, and References

Medical Policy Group, December 2011: 2012 Code Updates – verbiage update to 95970

Medical Policy Group, June 2012 (3): 2012 Updates – Key Points & References

Medical Policy Panel, June 2013

Medical Policy Group, June 2013 (3): 2013 Updates to Policy statement – anorexia nervosa, alcohol addiction, and chronic pain added to list of disorders (not an all-inclusive list) considered not to meet criteria for coverage), Key Points & References

Medical Policy Group, October 2013 (3): Removed ICD-9 Procedure codes; no change in policy statement.

Medical Policy Group, May 2014 (5): 2014 Coding Update:  Deleted code L8680 effective July 1, 2014.

Medical Policy Group, June 2014 (5): Quarterly 2014 Coding Update:  Code L8680 did not delete added back to policy under current codes.

Medical Policy Panel, November 2014

Medical Policy Group, November 2014 (3): Updates to Key Points, Key Words and References. Policy statement updated to include bilateral deep brain stimulation of thalamus as meeting criteria for disabling, medically unresponsive tremor in both limbs due to essential tremor or Parkinson disease.

Medical Policy Administration Committee, December 2014

Available for comment December 16 through January 29, 2015\

Medical Policy Panel, April 2016

Medical Policy Group, April 2016 (6): Updates to Key Points and References; clarification made to Policy statement – no change in policy intent.

Medical Policy Panel, April 2017

Medical Policy Group, May 2017 (6): Updates to Key Points, Governing Bodies and References.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (6): Updates to Key Points, Governing Bodies and References.

Medical Policy Group, June 2018:  Removed effective for dates of service prior to November 13, 2014 policy statements from policy section.

Medical Policy Group, December 2018:  2019 Annual Coding Update.  Added CPT codes 95983 and 95984 to the Current coding section. Moved CPT codes from Current coding section to previous coding. Created previous coding section to include codes 95978 and 95979.

Medical Policy Panel, April 2019

Medical Policy Group, June 2019 (3): 2019 Updates to Description, Key Points, Practice Guidelines and Position Statements, References, and Key Words: added: Brio Neurostimulation System, Infinity DBS device, and epilepsy. No changes to policy statement or intent.

Medical policy Group, October 2019 (3): 2019 Updates to Description, Key Points, Approved by Governing Bodies, References, and Key Words: added: Motor Cortex Stimulation, MCS, Cerebral Cortex Stimulation, CCS, Extradural Motor Cortex Stimulation (EMCS).

Policy statement added: Motor Cortex Stimulation is considered not medically necessary and investigational. No other changes to medical policy statement or intent. Title changed to Deep Brain and Motor Cortex Stimulation.

Medical Policy Panel, April 2020

Medical Policy Group, May 2020 (3): 2020 Updates to Key Points, Practice Guidelines and Position Statements, and References. Added Policy Guidelines Section. No changes to policy statements or intent.

Medical Policy Panel, April 2021

Medical Policy Group, May 2021 (3): 2021 Updates to Key Points, Practice Guidelines and Position Statements, Approved By Governing Bodies, References and Key Words: added: Percept PC DBS System, Vercise Genus DBS System, and Medtronic DBS System. Moved the diagnosis of multiple sclerosis from movement disorders in policy statement to neurological disorders. This did not change the investigational stance for the use of deep brain stimulation for the diagnosis of multiple sclerosis. Policy statement updated to remove “not medically necessary,” no other changes to policy statement or intent.

Medical Policy Panel, April 2022

Medical Policy group, May 2022 (3): 2022 Updates to Key Points, Practice Guidelines and Position Statements, Approved By Governing Bodies, and References. No change to policy statement or intent.

Medical Policy Panel, April 2023

Medical Policy Group, May 2023 (3): 2023 Updates to Key Points, Practice Guidelines and Position Statements, Benefit Applications, Approved By Governing Bodies, and References. Previous Coding Section removed. No changes to policy statement or intent.

Medical Policy Panel, April 2024

Medical Policy Group, May 2024 (3): Updates to Key Points, Approved By Governing Bodies, and References. Policy statement clarification: Alzheimer disease added and is investigational. No changes to policy statement or intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.