Notification



Notification Issue Date:



Medical Policy Bulletin


Title:Deep Brain Stimulation (DBS)

Policy #:11.15.20o

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

Coverage is subject to the terms, conditions, and limitations of the member's contract.

MEDICALLY NECESSARY

UNILATERAL DEEP BRAIN STIMULATION (DBS) OF THE THALAMUS FOR ESSENTIAL TREMOR (ET) OR PARKINSONIAN TREMOR
Unilateral stimulation of the thalamus using a US Food and Drug Administration (FDA)-approved deep brain stimulator according to the labeled indications for ET or Parkinsonian tremor is considered medically necessary and, therefore, covered when the individual has disabling medically refractive ET or disabling medically refractive tremors associated with Parkinson's disease (PD)*.

*Note: Disabling medically refractive tremors are defined as tremors that cause significant limitation in daily activities and are inadequately controlled with the maximum dosage of medication for at least three months before implant.

BILATERAL DBS OF THE THALAMUS FOR ET OR PARKINSONIAN TREMOR
Bilateral stimulation of the thalamus using a US Food and Drug Administration (FDA)-approved deep brain stimulator according to the labeled indications for ET or Parkinsonian tremor is considered medically necessary and, therefore, covered when the individual has disabling medically refractive tremors in both upper limbs associated with ET or disabling medically refractive tremors in both upper limbs associated with PD.

BILATERAL DBS OF THE GLOBUS PALLIDUS INTERNA (GPi) OR SUBTHALAMIC NUCLEUS FOR PD WITH RECENT ONSET OF MOTOR COMPLICATIONS
Bilateral stimulation of the GPi or subthalamic nucleus using a US Food and Drug Administration (FDA)-approved deep brain stimulator according to the labeled indications is considered medically necessary and, therefore, covered as an adjunct to medical therapy when the individual has an established diagnosis of PD for at least four years duration and all of the following criteria are met:
  • PD responsive to levodopa therapy
  • A neurosurgeon determines that the individual meets a minimal score of six on the Unified Parkinson's Disease Rating Scale (UPDRS) following the discontinuation of medications for approximately 12 hours
  • Recently developed (three years or less) motor complications (e.g., drug-induced dyskinesias, motor fluctuations) not adequately controlled with pharmacologic therapy, that cause significant limitations in daily activities

UNILATERAL OR BILATERAL DBS OF THE GPi OR SUBTHALAMIC NUCLEUS FOR ADVANCED PD
Unilateral or bilateral stimulation of the GPi or subthalamic nucleus using a US Food and Drug Administration (FDA)-approved deep brain stimulator according to the labeled indications is considered medically necessary and, therefore, covered when the individual has an established diagnosis of advanced PD and all of the following criteria are met:
    • PD responsive to levodopa therapy
    • A neurosurgeon determines that the individual meets a minimal score of 30 on the UPDRS following the discontinuation of medications for approximately 12 hours
    • Motor complications (e.g., drug-induced dyskinesias, motor fluctuations) refractory to pharmacologic therapy
HUMANITARIAN DEVICE EXEMPTION (HDE)

UNILATERAL OR BILATERAL DBS OF THE GPi OR SUBTHALAMIC NUCLEUS FOR PRIMARY DYSTONIA
Unilateral or bilateral stimulation of the GPi or subthalamic nucleus for primary dystonia is covered for the following US Food and Drug Administration (FDA)-approved humanitarian device exemption (HDE) indication:
  • Chronic, intractable (refractory to pharmacologic therapy) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in individuals seven years of age or older.

BILATERAL DBS OF THE ANTERIOR LIMB OF THE INTERNAL CAPSULE (AIC) FOR OBSESSIVE COMPULSIVE DISORDER (OCD)
Bilateral DBS of the AIC, as an adjunct to pharmacologic therapy, is covered for the following FDA-approved HDE indication:
  • Severe obsessive compulsive disorder (OCD)
    • Alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant OCD in adults who have failed at least three selective serotonin reuptake inhibitors (SSRIs)

An HDE may only be used in facilities that have an institutional review board (IRB) to oversee the clinical application of such devices. The IRB must approve the application of the device to ensure that it will be used in accordance with the FDA-approved indication(s). In addition, documentation of IRB approval may be requested by the Company to ensure compliance with the HDE indication(s).

NOT MEDICALLY NECESSARY

For individuals who meet the above medically necessary indications for DBS, but due to the presence of any of the following comorbidities, unilateral or bilateral deep brain stimulation is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use:
  • Non-idiopathic Parkinson's disease or "Parkinson's Plus" syndromes
  • Cognitive impairment, dementia, or depression, which would be worsened by or would interfere with the patient's ability to benefit from DBS
  • Current psychosis, alcohol abuse, or other drug abuse
  • Structural lesions such as basal ganglionic stroke, tumor, or vascular malformation as etiology of the movement disorder
  • Previous movement disorder surgery within the affected basal ganglion
  • Significant medical, surgical, neurologic, or orthopedic comorbidities contraindicating surgery or stimulation
  • Botulinum toxin injections within the last six months

EXPERIMENTAL/INVESTIGATIONAL

Deep brain stimulation for all other primary indications, including, but not limited to the following are considered experimental/investigational and, therefore, not covered because their safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.
  • Alcohol addiction
  • Alzheimer's disease
  • Anorexia nervosa
  • Blepharospasm
  • Cerebral palsy
  • Chronic cluster headache
  • Chronic pain syndrome including complex regional pain syndrome/reflex sympathetic dystrophy
  • Chronic vegetative state
  • Depression
  • Epilepsy
  • Head or voice tremor
  • Huntington's disease
  • Multiple Sclerosis tremor
  • Obesity
  • Post-traumatic dyskinesia
  • Tardive dyskinesia
  • Tourette syndrome

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the service.
Guidelines

CONTRAINDICATIONS FOR UNILATERAL OR BILATERAL DEEP BRAIN STIMULATION
  • Medical conditions that require exposure to diathermy (deep heat treatment including short-wave diathermy, microwave diathermy, and ultrasound diathermy)
  • Medical conditions that require exposure to magnetic resonance imaging (MRI) using a full body radio-frequency (RF) coil, a receive-only head coil, or a head transmit coil that extends over the chest area
  • Inability to properly operate the stimulator

CAUTIONARY USE OF DEEP BRAIN STIMULATION

Deep brain stimulation (DBS) should be performed with extreme caution in individuals with cardiac pacemakers or other electronically controlled implants, which may adversely affect or be affected by the DBS system.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, DBS is covered under the medical benefits of the Company’s products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as experimental/investigational are not eligible for coverage or reimbursement by the Company.

Subject to the terms and conditions of the applicable benefit contract, devices that are used for the FDA-approved humanitarian device exemption (HDE) indications listed in this policy are covered under the medical benefits of the Company's products.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

There are numerous devices approved by the FDA for Essential Tremor and Parkinson's disease indications

There are numerous devices approved by the FDA under the HDE process for primary dystonia and obsessive compulsive disorder (OCD) indications.
Description

DEEP BRAIN STIMULATION


Deep brain stimulation (DBS) may be used for individuals who become less responsive to medical treatments for essential tremor (ET), tremor associated with Parkinson's disease (PD), primary dystonia, and obsessive compulsive disorder (OCD), or for those who cannot tolerate the side effects from medications that are commonly used to treat these conditions. DBS has several potential advantages over ablative procedures (e.g., pallidotomy) because it is nondestructive and reversible. DBS may also provide better long-term results than can be achieved by a single ablative procedure. PD and ET are progressive diseases, and different neurostimulator parameters may be needed for these conditions over time to achieve optimal symptom control.

DBS is a high-frequency electrical stimulation of targeted nuclei deep within the brain that controls movement and muscle function. DBS is a neurosurgical procedure that involves stereotactic placement of implantable electrodes within targeted nuclei on one (unilateral) or both (bilateral) sides of the brain. There are currently three targeted sites for DBS: the thalamic ventralis intermedius nucleus (VIM), subthalamic nucleus (STN), and globus pallidus interna (GPi). Once effectiveness has been demonstrated by temporary stimulation, the individual returns to surgery, usually within several days, for subcutaneous placement of the pulse generator (neurostimulator) in the chest and subcutaneous placement of the cable that connects the pulse generator to the implanted electrodes. Following implantation, noninvasive programming of the neurostimulator can be adjusted according to the individual's symptoms. The system can also be independently activated by the individual as needed.

ESSENTIAL TREMOR (ET)

ET is a progressive, disabling disorder most often affecting the hands, but it may also affect the head, voice, or legs. The exact etiology of ET is unknown. It may start at any age but peaks within the second and sixth decades of life. Beta-adrenergic blockers and anticonvulsant medications are usually first-line treatments for reducing the severity of tremors. However, many individuals do not adequately respond to or cannot tolerate these medications.

One of the earlier tremor scales developed that is still widely used today is the Fahn–Tolosa–Marin Tremor Rating Scale (TRS). This five-point scale rates tremor severity based on tremor amplitude, from zero (no tremor) to four (severe tremor) in each part of the body, and includes assessments of specific abilities and functional disability.

PARKINSON'S DISEASE (PD)

PD is a chronic and progressive neurodegenerative disease of unknown etiology. The disorder involves the loss of dopaminergic cells in the substantia nigra of the midbrain, which leads to the depletion of dopamine, a neurotransmitter that is essential for the regulation of motor function throughout the body. PD is characterized by tremor, rigidity (a stiffness of the limbs), bradykinesia/akinesia (slowness of motor movements/inability to initiate movement), and progressive postural instability. There are also many non-motor symptoms, including depression, anxiety, apathy, fatigue, and sexual dysfunction. Dopaminergic medication is typically used as a first-line treatment for reducing the primary symptoms of PD. However, after prolonged use, medication can become less effective and can produce significant adverse events such as dyskinesias (abnormality with voluntary muscle movements).

PD staging is accomplished through various rating tools, including the Hoehn and Yahr Staging of Parkinson's Disease, Unified Parkinson's Disease Rating Scale [UPDRS], and the Schwab and England Activities of Daily Living. The UPDRS is a rating tool to follow the longitudinal course of PD. It is made up of three sections: 1) Mentation, Behavior, and Mood; 2) Activities of Daily Living (ADL); and 3) Motor. These sections are evaluated by individual interviews. Some sections require multiple grades assigned to each extremity. A total of 199 points are possible. A score of 199 represents the worst (total) disability, and a score of zero represents no disability.

PRIMARY DYSTONIA

Primary dystonia is a neurological movement disorder of unknown etiology characterized by involuntary muscle contractions that force parts of the body into abnormal, contorted, and painful movements or postures. Primary dystonia is classified as focal (limited to one area [e.g., torticollis]), multifocal (affecting many areas [e.g., eyes, jaw, and tongue]), or generalized (affecting the entire body [e.g., arms, legs, and trunk]). When conservative therapy, such as oral or injectable medications (e.g., benztropine, diazepam, botulinum toxin) has failed, treatment options have included destructive neurosurgical interventions (e.g., thalamotomy, pallidotomy).

The US Food and Drug Administration (FDA) approved the Medtronic Activa® Dystonia Therapy (Medtronic Inc.; Minneapolis, MN) on April 15, 2003, as a Humanitarian Drug Exemption (HDE). It is indicated for the management of long-term primary dystonia in individuals seven years of age and older who are not responsive to drug therapy. The device may improve some symptoms associated with primary dystonia.

OBSESSIVE COMPULSIVE DISORDER (OCD)

OCD is an anxiety disorder and is characterized by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors (compulsions). Repetitive behaviors such as hand-washing, counting, checking, or cleaning are often performed with the hope of preventing obsessive thoughts or making them go away. Performing these behaviors, however, provides only temporary relief, and not performing them markedly increases anxiety.

The FDA approved the Medtronic Reclaim® DBS Therapy for OCD (Medtronic Inc.; Minneapolis, MN) on February 19, 2009 (as a humanitarian device exemption [HDE]) for the treatment of chronic, severe, treatment-resistant OCD in adult individuals having failed three selective serotonin reuptake inhibitors (SSRIs). This device is indicated for bilateral stimulation of the anterior limb of the internal capsule (AIC), as adjunctive to medications, and as an alternative to anterior capsulotomy for the treatment of OCD. The generic name for the Medtronic Reclaim® is Implantable Multi-Programmable Quadripolar Deep Brain Stimulation System.

HUMANITARIAN DEVICE EXEMPTION (HDE)

In rare instances, certain medical devices intended to be used for humanitarian purposes are evaluated by the FDA through the HDE process. The FDA’s humanitarian use device (HUD) designation permits the use of certain medical devices when there is no comparable device available to treat or diagnose a disease or condition affecting fewer than 4,000 individuals annually. Because clinical investigation demonstrating the efficacy of the device is not feasible (given the low prevalence of the disease in the population), an HDE grants manufacturers an exemption to the usual premarket approval process and allows marketing of the device only for the FDA-labeled HDE indication(s).

Under FDA requirements, an HUD may only be used after institutional review board (IRB) approval has been obtained for the use of the device in accordance with the FDA-labeled indication(s) under the HDE.

OTHER PROPOSED APPLICATIONS FOR DBS

Deep brain stimulation is also being investigated for the treatment of disorders such as treatment resistant depression, chronic cluster headaches, chronic pain syndromes, Tourette syndrome, multiple sclerosis tremor, and refractory epilepsy. Available published peer-reviewed literature demonstrates insufficient evidence upon which to support its effectiveness of these and other proposed indications. Additional controlled studies with larger number of subjects are required to evaluate the role of DBS for these proposed conditions.


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National Institute for Clinical Excellence (NICE). Interventional Procedure Guidance 382: Deep brain stimulation for refractory chronic pain syndromes (excluding headache) [NICE Web site]. March 2011. Available at: http://guidance.nice.org.uk/IPG382. Accessed December 14, 2016.

National Institute for Clinical Excellence (NICE). Interventional Procedure Guidance 416: Deep brain stimulation for refractory epilepsy. [NICE Web site]. January 2012. Available at: http://www.nice.org.uk/ipg416. Accessed December 14, 2016.

National Institute for Clinical Excellence (NICE). Interventional Procedure Guidance 19: Deep brain stimulation for Parkinson’s disease. [NICE Web site]. November 2003. Available at: http://www.nice.org.uk/guidance/IPG19/resources. Accessed December 14, 2016.

National Institute for Clinical Excellence (NICE). Interventional Procedure Guidance 188: Deep brain stimulation for tremor and dystonia (excluding Parkinson’s disease). [NICE Web site]. August 2006. Available at: http://www.nice.org.uk/guidance/IPG188/resources. Accessed December 14, 2016.

National Institute of Mental Health (NIMH). What is Obsessive Compulsive Disorder (OCD). [NIMH Web site]. January 2016. Available at: http://www.nimh.nih.gov/health/topics/obsessive-compulsive-disorder-ocd/index.shtml. Accessed December 14, 2016.

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Mallet L, Polosan M, Jaafari N, et al. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008;359(20) 2121- 2134.

Massachusetts General Hospital (MGH). Functional and stereotactic neurosurgery. Neurosurgical service. Hoehn and Yahr staging of Parkinson's disease, unified Parkinson disease rating scale (UPDRS), and Schwab and England activities of daily living. [MGH Web site]. 2005. Available at: http://neurosurgery.mgh.harvard.edu/Functional/pdstages.htm. Accessed December 14, 2016.

Miyawaki E, Perlmutter JS, Troster AI, Videen TO, Koller WC. The behavioral complications of pallidal stimulation: a case report. Brain Cogn. 2000;42(3):417-434.

Molinuevo JL, Valldeoriola F, Tolosa E, et al. Levodopa withdrawal after bilateral subthalamic nucleus stimulation in advanced Parkinson disease. Arch Neurol. 2000;57(7):983-988.

Moro E, Scerrati M, Romito LM, et al. Chronic subthalamic nucleus stimulation reduces medication requirements in Parkinson's disease. Neurology. 1999;53(1):85-90.

Morrison CE, Borod JC, Brin MF, et al. A program for neuropsychological investigation of deep brain stimulation (PNIDBS) in movement disorder patients: development, feasibility, and preliminary data. Neuropsychiatry Neuropsychol Behav Neurol. 2000;13(3):204-219.

Nutt JG, Anderson VC, Peacock JH, Hammerstad JP, Burchiel KJ. DBS and diathermy interaction induces severe CNS damage. Neurology. 2001;56(10):1384-1386.

Obeso JA, Rodriguez-Oroz MC, Chana P, et al. The evolution and origin of motor complications in Parkinson's disease. Neurology. 2000;55(11 suppl 4):S13-S20.

Obeso JA, Rodriguez-Oroz MC, Rodriguez M, et al. Pathophysiologic basis of surgery for Parkinson's disease. Neurology. 2000;55(12 suppl 6):S7-S12.

Olanow CW, Brin MF, Obeso JA. The role of deep brain stimulation as a surgical treatment for Parkinson's disease. Neurology. 2000;55(12 suppl 6):S60-S66.

Olanow CW, Watts RL, Koller WC. An algorithm (decision tree) for the management of Parkinson's disease (2001): treatment guidelines. Neurology. 2001;56(11 suppl 5):S1-S88.

Pansaon 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. 2012;71(1):173-192.

Parkin AJ, Java RI. Deterioration of frontal lobe function in normal aging: influences of fluid intelligence versus perceptual speed. Neuropsychology. 1999;13(4):539-545.

Pahwa R, Factor SA, Lyons KE, et al. Practice Parameter: treatment of Parkinson disease with motor fluctuations and dyskinesia (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2006;66(7):983-995.

Pillon B, Ardouin C, Damier P, et al. Neuropsychological changes between "off" and "on" STN or GPi stimulation in Parkinson's disease. Neurology. 2000;55(3):411-418.

Porta M, Brambilla A, Cavanna AE, et al. Thalamic deep brain stimulation for treatment-refractory Tourette syndrome: Two-year outcome. Neurology. 2009;73(17):1375-1380.

Putzke JD, Uitti RJ, Obwegeser AA, Wszolek ZK, Wharen RE. Bilateral thalamic deep brain stimulation: midline tremor control. J Neurol Neurosurg Psychiatry. 2005;76(5):684-690.

Rabins P, Appleby BS, Brandt J, et al. Scientific and ethical issues related to deep brain stimulation for disorders of mood, behavior, and thought. Arch Gen Psychiatry. 2009;66(9):931-937.

Rasche D, Rinaldi PC, Young RF, et al. Deep brain stimulation for the treatment of various chronic pain syndromes. Neurosurg Focus. 2006;21(6):E8.

Rizzone M, Lanotte M, Bergamasco B, et al. Deep brain stimulation of the subthalamic nucleus in Parkinson's disease: effects of variation in stimulation parameters. J Neurol Neurosurg Psychiatry. 2001;71(2):215-219.

Robertson LT, Horak FB, Anderson VC, Burchiel KJ, Hammerstad JP. Assessments of axial motor control during deep brain stimulation in parkinsonian patients. Neurosurgery. 2001;48(3):544-552.

Rodriguez-Oroz MC, Gorospe A, Guridi J, et al. Bilateral deep brain stimulation of the subthalamic nucleus in Parkinson's disease. Neurology. 2000;55(12 suppl 6):S45-S51.

Saint-Cyr JA, Trepanier LL, Kumar R, Lozano AM, Lang AE. Neuropsychological consequences of chronic bilateral stimulation of the subthalamic nucleus in Parkinson's disease. Brain. 2000;123(pt 10):2091-2108.

Salanova V, Witt T, Worth R, et al. Long-term efficacy and safety of thalamic stimulation for drug-resistant partial epilepsy. Neurology.2015;84(10):1017-1025.

Schulz GM, Grant MK. Effects of speech therapy and pharmacologic and surgical treatments on voice and speech in Parkinson's disease: A review of the literature. J Commun Disord. 2000;33(1):59-88.

Schuepbach WM, Rau J, Knudsenet K, et al. Neurostimulation for Parkinson’s disease with early motor complications. N Engl J Med. 2013;368(7):610-622.

Schuepbach WM, Maltęte D, Houeto JL, et al. Neurosurgery at an earlier stage of Parkinson disease: a randomized, controlled trial. Neurol. 2007;23;68(4):267-271.

Schupbach WM, Maltete D, Houeto JL, et al. Neurosurgery at an earlier stage of Parkinson disease: a randomized, controlled trial. Neurology. 2007;68(4):267-271.

Scotto di Luzio AE, Ammannati F, Marini P, Sorbi S, Mennonna P. Which target for DBS in Parkinson's disease? Subthalamic nucleus versus globus pallidus internus. Neurol Sci. 2001;22(1):87-88.

Senatus PB, McClelland S, Ferris AD, et al. Implantation of bilateral deep brain stimulators in patients with Parkinson disease and preexisting cardiac pacemakers. Report of two cases. J Neurosurg.2004 ;101(6):1073-1077.

Servello D, Zekaj E, Saleh C, et al. 16 years of deep brain stimulation in tourette's syndrome: a critical review. J Neurosurg Sci. 2016. PMID 26788742

Sirven JI. Evaluation and management of drug-resistant epilepsy. Up to Date.[UpToDate Web site]. 09/09/2016. Available at: http://www.uptodate.com/home/index.html. [via subscription only]. Accessed December 14, 2016.

Sherry DD. Complex regional pain syndrome in children. UpToDate [serial online]. Waltham, MA: UpToDate; updated 03/22/2016.

Sprengers M, Vonck K, Carrette E, et al. Deep brain and cortical stimulation for epilepsy. Cochrane Database Syst Rev. 2014;6:CD008497. doi: 10.1002/14651858.CD008497.pub2. http://www.ncbi.nlm.nih.gov/pubmed/24937707.

Starr PA, Vitek JL, DeLong M, Bakay RA. Magnetic resonance imaging-based stereotactic localization of the globus pallidus and subthalamic nucleus. Neurosurgery. 1999;44(2):303-314.

Stebbins GT, Gabrieli JD, Shannon KM, Penn RD, Goetz CG. Impaired frontostriatal cognitive functioning following posteroventral pallidotomy in advanced Parkinson's disease. Brain Cogn. 2000;42(3):348-363.

Steeves T, McKinlay BD, Gorman D, et al. Canadian guidelines for the evidence-based treatment of tic disorders: behavioural therapy, deep brain stimulation, and transcranial magnetic stimulation. Can J Psychiatry. 2012;57(3):144-51.

Straits-Tröster K, Fields JA, Wilkinson SB, et al. Health-related quality of life in Parkinson's disease after pallidotomy and deep brain stimulation. Brain Cogn. 2000;42(3):399-416.

Temel Y, Visser-Vandewalle V. Surgery in Tourette syndrome. Mov Disord. 2004;19(1):3-14.

Tekriwal A, Baltuch G. Deep brain stimulation: expanding applications. Neurol Med Chir (Tokyo).2015; 55(12): 861–877.

Timmermann L, Deuschl G, Fogel W, et al; Deep Brain Stimulation Association. Deep brain stimulation for tremor in multiple sclerosis: Consensus recommendations of the German Deep Brain Stimulation Association. Nervenarzt. 2009;80(6):673-677.

Tomaszewski KJ, Holloway RG. Deep brain stimulation in the treatment of Parkinson's disease: a cost-effectiveness analysis. Neurology. 2001;57(4):663-671.

Trepanier LL, Kumar R, Lozano AM, Lang AE, Saint-Cyr JA. Neuropsychological outcome of GPi pallidotomy and GPi or STN deep brain stimulation in Parkinson's disease. Brain Cogn. 2000;42(3):324-347.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). CDRH Consumer Information Medtronic Activa Dystonia Therapy- H020007. [FDA Web site]. Original: 04/15/03. (Revised: 09/04/13). Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm082535.htm. Accessed December 14, 2016.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). H020007: Medtronic Activa® Dystonia Therapy. Humanitarian device exemption (HDE) application approval. [FDA Web site]. 04/15/03. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf2/H020007a.pdf. Accessed December 14, 2016.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Medtronic® Activa™ Tremor Control System. Premarket approval letter. [FDA Web site]. 07/31/97. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p960009.pdf. Accessed December 14, 2016.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). Medtronic Reclaim® DBS for OCD. Summary of Safety and Probable Benefit. [FDA Web site]. 03/21/05. Available at:http://www.accessdata.fda.gov/cdrh_docs/pdf5/H050003b.pdf. Accessed December 14, 2017.

US Food and Drug Administration (FDA). Center for Devices and Radiological Health (CDRH). P960009/S7: Medtronic Activa® Parkinson's Control System. Premarket approval letter. [FDA Web site]. 01/14/02. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p960009S7a.pdf. Accessed December 14, 2016.

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Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

61863, 61864, 61867, 61868, 61880, 61885, 61886, 61888, 95836, 95961, 95962, 95970, 95983, 95984


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

F42.8 Other obsessive-compulsive disorder

F42.9 Obsessive-compulsive disorder, unspecified

G20 Parkinson's disease

G24.1 Genetic torsion dystonia

G24.2 Idiopathic nonfamilial dystonia

G24.3 Spasmodic torticollis

G24.8 Other dystonia

G24.9 Dystonia, unspecified

G25.0 Essential tremor

G25.2 Other specified forms of tremor

M43.6 Torticollis




HCPCS Level II Code Number(s)


C1767 Generator, neurostimulator (implantable), nonrechargeable

C1778 Lead, neurostimulator (implantable)

C1787 Patient programmer, neurostimulator

C1816 Receiver and/or transmitter, neurostimulator (implantable)

C1820 Generator, neurostimulator (implantable), with rechargeable battery and charging system

C1823 Generator, neurostimulator (implantable), non-rechargeable, with transvenous sensing and stimulation leads

C1883 Adaptor/extension, pacing lead or neurostimulator lead (implantable)

L8679 Implantable neurostimulator, pulse generator, any type

L8680 Implantable neurostimulator electrode, each

L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only

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

L8689 External recharging system for battery (internal) for use with implantable neurostimulator, replacement only

L8695 External recharging system for battery (external) for use with implantable neurostimulator, replacement only




Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

01/01/2019Inclusion of a policy in a Code Update memo does not imply that a full review of
the policy was completed at this time.

This policy has been identified for the HCPCS code update, effective 01/01/2019.

The following HCPCS codes have been deleted from this policy:

95978, 95979

The following HCPCS codes have been added to this policy:

95836, 95983, 95984, C1823

The following HCPCS codes have been revised in this policy:

95970
Version Effective Date: 01/01/2019
Version Issued Date: 01/03/2019
Version Reissued Date: N/A

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