Notification



Notification Issue Date:



Medicare Advantage Policy

Title:Deep Brain Stimulation (DBS)
Policy #:MA11.005c

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


The Company makes decisions on coverage based on the Centers for Medicare and Medicaid Services (CMS) regulations and guidance, benefit plan documents and contracts, and the member’s medical history and condition. If CMS does not have a position addressing a service, the Company makes decisions based on Company Policy Bulletins. 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. Although the Medicare Advantage Policy Bulletin is consistent with Medicare’s regulations and guidance, the Company’s payment methodology may differ from Medicare.

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 Policy Bulletin document describes the status of CMS coverage, medical terminology, and/or benefit plan documents and contracts at the time the document was developed. This Policy Bulletin will be reviewed regularly and be updated as Medicare changes their regulations and guidance, scientific and medical literature becomes available, and/or the benefit plan documents and/or contracts are changed.



Policy

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

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.

MEDICALLY NECESSARY

Unilateral or bilateral thalamic ventralis intermedius nucleus (VIM) deep brain stimulation (DBS) for the treatment of essential tremor (ET) and/or Parkinsonian tremor and unilateral or bilateral subthalamic nucleus (STN) or globus pallidus interna (GPi) DBS for the treatment of Parkinson's disease (PD) is considered medically necessary and, therefore, covered only under the following conditions:
  • The device is Food and Drug Administration (FDA) approved for DBS or used in accordance with FDA-approved protocols governing Category B Investigational Device Exemption (IDE) DBS clinical trials.
  • For thalamic VIM DBS to be considered medically necessary and, therefore, covered, the individual must meet all of the following criteria:
    • Diagnosis of ET based on postural or kinetic tremors of hand(s) without other neurologic signs, or diagnosis of idiopathic PD (presence of at least two cardinal PD features [tremor, rigidity or bradykinesia]) that is of a tremor-dominant form
    • Marked disabling tremor of at least level 3 or 4 on the Fahn-Tolosa-Marin Clinical Tremor Rating Scale (or equivalent scale) in the extremity intended for treatment, causing significant limitation in daily activities despite optimal medical therapy
    • Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications, and stimulator settings
  • For STN or GPi DBS to be considered medically necessary and, therefore, covered, the individual must meet all of the following criteria:
    • Diagnosis of PD based on the presence of at least two cardinal PD features (tremor, rigidity or bradykinesia)
    • Advanced idiopathic PD as determined by the use of Hoehn and Yahr stage or Unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale
    • L-dopa responsive with clearly defined "on" periods
    • Persistent disabling Parkinson's symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy
    • Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications, and stimulator settings

For DBS lead implantation to be considered medically necessary and, therefore, covered, providers and facilities must meet all of the following criteria:
  • Neurosurgeons must:
    • Be properly trained in the procedure;
    • Have experience with the surgical management of movement disorders, including DBS therapy; and
    • Have experience performing stereotactic neurosurgical procedures.
  • Operative teams must have training and experience with DBS systems, including knowledge of anatomical and neurophysiological characteristics for localizing the targeted nucleus, surgical and/or implantation techniques for the DBS system, and operational and functional characteristics of the device. Professional providers specializing in movement disorders must be involved in both individual selection and post-procedure care.
  • Hospital medical centers must have:
    • Brain imaging equipment (MRI and/or CT) for pre-operative stereotactic localization and targeting of the surgical site(s);
    • Operating rooms with all necessary equipment for stereotactic surgery; and
    • Support services necessary for care of individuals undergoing this procedure and any potential complications arising intraoperatively or postoperatively.

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 co-morbidities contraindicating DBS surgery or stimulation

EXPERIMENTAL/INVESTIGATIONAL

Deep brain stimulation for all other primary indications 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.

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.
Policy Guidelines

This policy is consistent with Medicare's coverage determination. The Company's payment methodology may differ from Medicare.

Individuals who undergo DBS implantation should not be exposed to diathermy (deep heat treatment including shortwave diathermy, microwave diathermy, and ultrasound diathermy) or any type of MRI, which may adversely affect the DBS system or adversely affect the brain around the implanted electrodes.

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 Evidence of Coverage, deep brain stimulation (DBS) is covered under the medical benefits of the Company’s Medicare Advantage products when the medical necessity criteria listed in this medical policy are met. However, services that are identified in this policy as not medically necessary are not eligible for coverage or reimbursement by the Company.

Description

DEEP BRAIN STIMULATION

Deep brain stimulation (DBS) may be used for individuals who become less responsive to medical treatments for essential tremor (ET) and tremor associated with Parkinson's disease (PD). 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 – most prominently – 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.
References


Centers for Medicare & Medicaid Services (CMS). Decision Memo for Deep Brain Stimulation for Parkinson's Disease (CAG-00124N). [CMS Web site]. 02/06/2003. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=21&TAId=15&IsPopup=y&bc=AAAAAAAACAAAAA%3d%3d& Accessed July 02, 2019.

Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD) 160.24: Deep brain stimulation for essential tremor and Parkinson’s disease. [CMS Web site]. 4/01/2003. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=279&ncdver=1&DocID=160.24&list_type=ncd&bc=gAAAAAgAAAAA&. Accessed July 02 , 2019.



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)

G20 Parkinson's disease

G25.0 Essential tremor

G25.2 Other specified forms of tremor



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 (with any number of contact points), 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

Revisions from MA11.005c

07/31/2019The policy has been reviewed and reissued to communicate the Company’s continuing position on Deep Brain Stimulation (DBS).
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 CPT/HCPCS code update, effective 01/01/2019.

The following CPT codes have been deleted from this policy: 95978, 95979

The following CPT codes have been added to this policy: 95836, 95983, 95984

The following CPT codes have been revised in this policy: 95970

The following HCPCS code has been added to this policy: C1823


Revisions from MA11.005b
05/24/2017The policy has been reviewed and reissued to communicate the Company’s continuing position on deep brain stimulation.
06/24/2016The policy has been reviewed and reissued to communicate the Company’s continuing position on Deep Brain Stimulation (DBS).

Experimental/Investigational statement added for all other indications where safety and/or effectiveness cannot be established by review of the available published peer-reviewed literature.

The following CPT codes have been removed from this policy: 95971, 95972.

The following HCPCS codes have been added to this policy as Medically Necessary: C1767, C1778, C1787, C1816, C1820, C1883.


Revisions from MA11.005a
01/01/2016The following CPT code has been deleted from this policy: 95973

The following CPT narrative has been revised in this policy: 95972


Revisions from MA11.005
03/08/2015The policy has been reviewed and reissued to communicate the Company’s continuing position on Deep Brain Stimulation (DBS).
01/01/2015This is a new policy.






Version Effective Date: 01/01/2019
Version Issued Date: 01/03/2019
Version Reissued Date: 07/31/2019