HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
Z-7-042
Topic:
Electrical Nerve Stimulation
Section:
Miscellaneous
Effective Date:
October 1, 2018
Issued Date:
October 1, 2018
Last Revision Date:
September 2018
Annual Review:
July 2018
 
 

Electrical nerve stimulation is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes.

Policy Position Coverage is subject to the specific terms of the member's benefit plan.

Unilateral or bilateral deep brain stimulation (DBS) of the thalamic ventralis intermedius nucleus (VIM) may be considered medically necessary for the treatment of intractable tremors due to essential tremor or Parkinson's disease (PD), when ALL of the following criteria are met:

  • Diagnosis of essential tremor or idiopathic Parkinson's disease (with the presence of at least two cardinal PD features - tremor, rigidity, bradykinesia) that is not responding satisfactorily to drug therapy; and
  • Marked disabling tremor of at least three (3) or four (4) on the Fahn-Tolosa-Marin Clinical Tremor Rating Scale (or equivalent scale), causing significant limitation in activities of daily living; and
  • No diagnosed dementia, severe depression, cerebral atrophy, or Hoehn and Yahr stage V Parkinson's disease; and
  • No focal lesion of the basal ganglia (e.g., a space occupying lesion or lacunae) at the target site that would negate the result of thalamic stimulation; and 
  • Sufficient residual motor function in the upper extremity so that it is reasonable to expect an improvement following the surgery; and
  • Willingness and ability of the individual to cooperate during a conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

Unilateral or bilateral deep brain stimulation of the subthalamic nucleus (STN) or globus pallidus interna (GPi) for the treatment of Parkinson's disease may be considered medically necessary when ALL of the following criteria are met:

  • Diagnosis of advanced idiopathic Parkinson's disease as determined by the Hoehn and Yahr stage or a minimal score of 30 points on the Unified Parkinson's Disease Rating Scale (UPDRS) part III motor subscale when off medication for 12 hours; and
  • Parkinson's disease (with the presence of at least two (2) cardinal PD features - tremor, rigidity, bradykinesia) that is not responding satisfactorily to drug therapy; and
  • Presence of disabling Parkinson's disease symptoms or medication side effects (e.g., dyskinesia’s, motor fluctuations, or disabling "off" periods), despite optimal medical therapy; and
  • No diagnosed dementia, severe depression, cerebral atrophy, or Hoehn and Yahr stage V Parkinson's disease; and
  • Parkinson's disease is Levodopa responsive with clearly defined "on" periods; and
  • Willingness and ability to cooperate during conscious operative procedure, as well as during post-surgical evaluations, adjustments of medications and stimulator settings.

Deep brain stimulation may be considered medically necessary when it is used as a treatment for chronic intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven (7) years of age or above.

Intensive electronic analysis and programming of a deep brain stimulator may be necessary immediately following implantation to achieve optimal stimulus parameters. Recognizing these needs, six (6) such programming visits will be covered within 60 days of the surgical implantation of the deep brain stimulator, and once every 30 days thereafter, as necessary.

Deep brain stimulation is considered experimental/investigational and therefore non-covered when used in ANY ONE of the following situations:

  • For other movement disorders, including but not limited to multiple sclerosis, post-traumatic dyskinesia, and tardive dyskinesia; or
  • For treatment of tremor from other causes such as trauma, degenerative disorders, metabolic disorders, or infectious diseases; or
  • For other indications, including cluster headaches, refractory depression, obsessive/compulsive disorder, and Tourette's syndrome.

Scientific evidence does not support the use of deep brain stimulation for any of the above indications.

61850

61863

61864

61867

61868

61880

61885

61886

61888

95961

95962

95970

95971

95972

95974

95975

95978

95979

L8680

L8681

L8682

L8683

L8685

L8686

L8687

L8688

L8689

 




Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS) may be considered medically necessary when used for the treatment of chronic intractable pain and as a means of assessing the need for continued treatment with an implanted electrical nerve stimulator.

  • Chronic intractable pain is defined as chronic pain that has no significant chance of being altered by usual treatment modalities or natural healing.  Examples of chronic intractable are as follows:
    • An episode of low back pain that has persisted for three months or longer; and
    • Is not a manifestation of a clearly defined and generally recognizable primary disease entity. For example, there are cancers that, through metastatic spread to the spine or pelvis, may elicit pain in the lower back as a symptom; and certain systemic diseases such as 0rheumatoid arthritis and multiple sclerosis manifest many debilitating symptoms

The use of PENS and TENS for conditions other than chronic intractable pain is considered experimental/investigational and therefore non-covered. Scientific evidence does not support its use for any other indications.

Transcutaneous electrical nerve stimulation (TENS) may be considered medically necessary when the chronic intractable pain causes significant disruption of function when ALL of the following have been met:

  • The individual is unresponsive to at least three (3) months of conservative medical therapy (e.g. non-steroidal anti-inflammatory medications, ice, rest and/or physical therapy); and
  • The individual is responsive to a trial of TENS for at least two (2) weeks performed under medical supervision (e.g. physical therapy). For example, a demonstration of a reduction in pain that is clinically significant as defined by accepted documented outcome measures (e.g. pain scale); and
  • The trial period is monitored and documented by a licensed professional that is qualified to provide treatment (e.g. physical therapist). 

64550

64555

64999

A4595

E0720

E0730

 




Supplies for electrical stimulation device may be considered medically necessary when annual documentation is noted in the individual's medical record.

Normal utilization with a covered electrical stimulation device is:

  • For two (2) lead device, four (4)  electrodes per month
  • For four (4) lead device, eight (8) electrodes per month 

64550

A4595

E0720

E0730

 

 

 




Phrenic nerve stimulator implantation may be considered medically necessary:

  • For treatment of chronic ventilator or respiratory insufficiency requiring mechanical ventilation due to either:
    • lesions/injury of the spinal cord at or above the C-3 vertebral level; or
    • central alveolar hypoventilation, either primary or secondary to a brain stem disorder; or
  • The phrenic nerve is viable and intact; and
  • Diaphragmatic function is sufficient to accommodate chronic stimulation.

The use of phrenic nerve stimulation for ANY other indications is considered experimental/investigational and therefore  non-covered. Scientific evidence does not support the use of phrenic nerve stimulation other than the above indications as stated above.

64999

L8680

 L8682

L8683

 

 

 




The implantation of a vagus (vagal) nerve stimulator for seizure control may be considered medically necessary only when used as a last resort for individuals with epilepsy with partial onset seizures. Medical necessity is limited to those cases where the seizures cannot be controlled by any other method, i.e., surgery or medication.

The use of Vagus (vagal) nerve stimulation is considered experimental/investigational as a treatment of other conditions, including but not limited to heart failure, fibromyalgia, depression, essential tremor, obesity, headaches, tinnitus, and traumatic brain injury and therefore non-covered.  Scientific evidence has not demonstrated the long-term clinical efficacy of VNS and its impact on treatment-resistant depression. 

Nonimplantable vagus nerve stimulation devices are considered Experimental/Investigational and, therefore, non-covered for all indications. There is lack of long term evidence based literature to confirm the efficacy and safety of these devices.

Implantable Hypoglossal Nerve Stimulators

Refer to medical policy Z-8 Diagnosis and Treatment of Obstructive Sleep Apnea for implantable hypoglossal nerve stimulators.

61885

61886

64553

64568

64569

64570

95970

95974

95975

E1399

L8680

L8681

L8682

L8683

L8685

L8686

L8687

L8688

L8689

 

 




The percutaneous or open (via incision) implantation of neuromuscular neurostimulator electrodes for chronic pain relief is considered experimental/investigational, and therefore non-covered. The clinical value of intramuscular stimulation for pain relief has not been validated by randomized controlled studies.

64580

64999

95971

95972

L8680

L8681

L8682

L8683

L8685

L8686

L8687

L8688

L8689

 




Occipital nerve stimulation (ONS) is considered experimental/investigational for ALL indications, and therefore, non-covered. Scientific evidence does not support its use for any indications.

61885

61886

64553

64555

64568

64569

64570

64575

64999

L8680

L8681

L8682

L8683

L8685

L8686

L8687

L8688

L8689

 

 

 




Replacement batteries are not eligible for payment and therefore non-covered.

A4630

 

 

 

 

 

 




Use of electrical nerve stimulators and related services other than those specifically addressed within this policy, e.g., percutaneous neuromodulation therapy (PNT), or for conditions other than those addressed within this policy (e.g., multiple sclerosis, muscular dystrophy, or other motor function disorders), is considered experimental/investigational and therefore non-covered.  Scientific evidence does not support the use of electrical stimulators or related services for any other indications.

C1778

C1816

C1822

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 




Related Policies

Refer to medical policy S-131, Sacral Nerve Neuromodulation/Stimulation, for additional information.

Refer to medical policy S-155, Gastric Electrical Stimulation, Gastric Pacing, for additional information.  

Refer to medical policy Y-16, Chronic Wound Management, for additional information.

Refer to medical policy E-45, Interferential Stimulator, for additional information.

Refer to medical policy E-40, Functional Neuromuscular Electrical Stimulation (NMES), for additional information.

Refer to medical policy O-9, Screening List for Prosthetics and Orthotics, for additional information.

Refer to medical policy Z-8, Diagnosis and Treatment of Obstructive Sleep Apnea for Adults, for additional information.


Covered Diagnosis Codes

Deep Brain Neurostimulation (61850, 61863, 61864, 61867, 61868, 61880, 61885, 61886, 61888)

G20

G21.11

G21.19

G21.2

G21.3

G21.4

G21.8

G24.02

G24.09

G24.1

G24.2

G24.3

G24.4

G24.8

G25.0

G25.1

G25.2

 

 

 

 

Vagus Nerve Stimulation (61885, 61886, 64553, 64568, 64569, 64570)

G40.001

G40.009

G40.011

G40.019

G40.101

G40.109

G40.111

G40.119

G40.201

G40.209

G40.211

G40.219

 

 



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

Electrical Nerve Stimulation is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business


Denial Statements

Services that do not meet the criteria of this policy will not be considered medically necessary. A network provider cannot bill the member for the denied service unless: (a) the provider has given advance written notice, informing the member that the service may be deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the member agrees in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

A network provider can bill the member for the non-covered service.

Quantity level limits or quantity of supplies that exceed the frequency guidelines listed in the policy will be denied as not medically necessary.



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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

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The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

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    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

    Insurance or benefit/claims administration may be provided by Highmark, Highmark Choice Company, Highmark Coverage Advantage, Highmark Health Insurance Company, First Priority Life Insurance Company, First Priority Health, Highmark Benefits Group, Highmark Select Resources, Highmark Senior Solutions Company or Highmark Senior Health Company, all of which are independent licensees of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield plans.