Deep Brain Stimulation

POLICY NUMBER

A.7.01.63

DESCRIPTION

Deep brain stimulation involves the stereotactic placement of an electrode into a central nervous system nucleus (eg, hypothalamus, thalamus, globus pallidus, subthalamic nucleus). Deep brain stimulation is used as an alternative to permanent neuroablative procedures for control of essential tremor and Parkinson disease. Deep brain stimulation is also being evaluated for the treatment of a variety of other neurologic and psychiatric disorders.

Deep Brain Stimulation

Deep brain stimulation involves the stereotactic placement of an electrode into the brain (ie, 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 patient returns for permanent subcutaneous surgical 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, use of bilateral stimulation using two electrode arrays has also been investigated in patients with bilateral, severe symptoms. After implantation, noninvasive programming of the neurostimulator can be adjusted to the patient’s symptoms. This feature may be important for patients with Parkinson disease, 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 adverse effects of neurostimulation, such as dysarthria, disequilibrium, or involuntary movements.

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 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 S318). Other deep brain stimulation systems are described in the table below.

Deep Brain Stimulation Systems

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

Note: The use of spinal cord stimulation as a treatment of chronic pain is addressed in a separate policy,  Spinal Cord and Dorsal Root Ganglion Stimulation .

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.

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:

1. Those with Parkinson disease and ALL of the following:

   1. a good response to levodopa; AND

   2. motor complications not controlled by pharmacologic therapy; AND

   3. one of the following:

      1. a minimal score of 30 points on the motor portion of the Unified Parkinson Disease Rating Scale when the patient has been without medication for approximately 12 hours; OR

      2. Parkinson disease for at least 4 years

2. Individuals older than 7 years with chronic, intractable (drug-refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis).

Adaptive deep brain stimulation for Parkinson disease is considered investigational (see Policy Guidelines).

Deep brain stimulation for other movement disorders, including but not limited to tardive dyskinesia and post-traumatic 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 epilepsy, Tourette syndrome, depression, obsessive-compulsive disorder, anorexia nervosa, alcohol addiction, Alzheimer disease, multiple sclerosis tremor, and chronic pain, is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

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 3 months before implant.

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.

Parkinson disease is a complex condition and might entail a complex system of care particularly when the disease has advanced. Adaptive DBS (aDBS) is a closed-loop system incorporating feedback from brain signals to dynamically adjust stimulation parameters. It is a more personalized approach to treatment of advanced disease and holds promise for reducing stimulation duration and energy consumption while treating motor related issues such as dyskinesia. The FDA submission for aDBS by Medtronic was as an optional programming feature for Parkinson’s Disease in existing devices. It was not studied in bilaterally implanted neurostimulators, and the labeling instructs not to use aDBS with more than one implanted neurostimulator.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

5/1998: Issued.

12/4/2000: Code reference section updated.

5/2001: Reviewed by Medical Policy Advisory Committee (MPAC); DBS for treatment of dystonia considered investigational.

2/13/2002: Investigational definition added.

3/6/2002: "The procedure must be performed in a BCBSMS approved center" deleted.

4/18/2002: Type of Service and Place of Service deleted.

5/6/2002: Code Reference section updated, CPT code 61855 deleted.

5/2002: Reviewed by MPAC; broader indications for otherwise untreatable Parkinsonism is medically necessary, Sources updated.

5/29/2002: Code Reference section updated, HCPCS C1767, C1816 added.

3/11/2004: Code Reference section updated, CPT code range 61850-61888 listed separately, HCPCS C1767, C1816, E0751, E0753 deleted, non-covered ICD-9 diagnosis codes 333.0, 333.6, 333.7, 340 deleted.

7/21/2005: Reviewed by MPAC, added "DBS for obsessive compulsive disorder is considered investigational."

10/17/2005: Code Reference table updated, codes 95978, 95979 added. Change description of  95970, 95971, 95972, 95973, 95974, 95975. 

11/15/2005: ICD9 procedure codes 86.97, 86.98 added.

3/13/2006: Policy reviewed, no changes.

03/22/2006: Coding updated. HCPCS 2006 revisions added to policy.

9/18/2007: Policy reviewed, no changes.

12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions.

8/18/2010: Policy description section updated, medically necessary indications for globus pallidus or subthalamic nucleus, primary dystonia, including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis) added to policy statement section. FEP verbiage added to the Policy Exceptions section. Detailed information regarding disabling, medically unresponsive tremor and contraindications of deep brain stimulation added to policy guidelines. Added ICD-9 codes 333.6, 333.79, 333.83 and 333.89. 

08/11/2011: Policy reviewed; policy statement unchanged. Deleted outdated references from the Sources section.

07/17/2012: Policy reviewed; no changes.

11/15/2013: Added anorexia nervosa, alcohol addiction, and chronic pain as investigational indications for deep brain stimulation.

12/31/2014: Code Reference section updated to revise the description of the following CPT code: 95972.

01/12/2015: Policy description updated regarding secondary dystonia and devices. Added the following policy statement: Bilateral deep brain stimulation of the thalamus may be considered medically necessary in patients with disabling, medically unresponsive tremor in both limbs due to essential tremor or Parkinson disease. Added Alzheimer disease as an investigational indication for deep brain stimulation.

08/25/2015: Code Reference section updated to add ICD-10 codes. Removed ICD-9 procedure code 01.24. Updated the code descriptions for 01.22, 02.93, 61885, and 61886. Removed deleted code 64573 from the policy and replaced with 64568.

12/31/2015: Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to revise the description for CPT code 95972.

05/31/2016: Policy number A.7.01.63 added. Removed deleted CPT code 61875 from the Code Reference section.

07/06/2016: Policy description updated. Medically necessary statement regarding bilateral deep brain stimulation updated to add "upper" to clarify that the statement refers to both upper limbs.

09/30/2016: Code Reference section updated to add new ICD-10 procedure code 05P002Z.

07/13/2017: Policy description updated regarding indications for Parkinson disease and devices. Medically necessary policy statement regarding unilateral or bilateral deep brain stimulation of the globus pallidus or subthalamic nucleus updated to add "Parkinson disease for at least 4 years" to criteria for patients with Parkinson disease.

05/04/2018: Policy description updated to add devices. Policy statements unchanged. Removed device information from the Policy Guidelines.

12/19/2018: Code Reference section updated to add new 2019 CPT codes 95976, 95977, 95983, and 95984. Revised code descriptions for CPT codes 95970, 95971, and 95972, effective 01/01/2019. Removed deleted CPT code 95973.

05/13/2019: Policy description revised and updated regarding devices. Policy statements unchanged.

05/20/2020: Policy description updated regarding deep brain stimulation systems. Policy statements unchanged. Code Reference section updated to remove deleted CPT codes 95974, 95975, 95978, and 95979.

12/22/2020: Code Reference section updated regarding deleted CPT code.

07/16/2021: Policy description updated regarding deep brain stimulation systems and indications. Policy statements updated to move multiple sclerosis from the investigational policy statement regarding other movement disorders to the investigational statement regarding other psychiatric or neurologic disorders. Intent unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

12/13/2021: Code Reference section updated to revise description for CPT codes 64568 and 64580, effective 01/01/2022.

06/01/2022: Policy description updated regarding deep brain stimulation systems. Policy statements unchanged. Code Reference section updated to remove deleted CPT code 61870.

05/15/2023: Policy reviewed. Policy statements and Policy Guidelines updated to change "patients" to "individuals."

09/28/2023: Code Reference section updated to add new ICD-10 diagnosis codes G20.A1, G20.A2, G20.B1, G20.B2, and G20.C, effective 10/01/2023.

05/21/2024: Policy reviewed; no changes.

06/05/2025: Policy description updated regarding deep brain stimulation systems. Policy section updated to add that adaptive deep brain stimulation for Parkinson disease is considered investigational (see Policy Guidelines). Policy Guidelines updated regarding Parkinson disease and adaptive deep brain stimulation. Code Reference section updated to remove deleted ICD-10 diagnosis code G20.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.63

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document. 

Covered Codes

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