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 circumstances may warrant individual consideration, based on review of applicable medical records.

Dorsal column stimulation, (spinal cord stimulation) and High Frequency Stimulation (HF10 Therapy) may be considered medically necessary for the relief of chronic intractable neurogenic pain of the trunk and/or limbs when ALL of the following conditions have been met:

• There is documented pathology, or an objective basis for the pain; and
• Dorsal column stimulation is being used as a late or last resort when other treatment modalities (pharmacological, surgical, physical, or psychological therapies) have been tried and did not prove satisfactory, cannot be tolerated, or are contraindicated; and
• A minimum 3 day trial of percutaneous spinal stimulation has resulted in a significant pain reduction of 50% or more; and
• There is no evidence of existing untreated drug addiction (per American Society of Addiction Medicine [ASAM] guidelines); and
• The patient has undergone careful physical and psychological evaluations prior to implantation; and
• The patient has been evaluated by a pain management specialist prior to implantation; and
• All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment training, and follow-up of the patient must be available.

The use of spinal cord stimulation for conditions other than chronic intractable neurogenic pain of the trunk and/or limbs, (for example, chronic stable refractory angina or peripheral ischemia) is considered experimental/investigational and therefore non-covered.  The medical effectiveness of such therapy has not been established

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 3 or 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 patient 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 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., dyskinesias, 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 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 the following situations:

• When used for other movement disorders, including but not limited to multiple sclerosis, post-traumatic dyskinesia, and tardive dyskinesia;
• When used for treatment of tremor from other causes such as trauma, degenerative disorders, metabolic disorders, or infectious diseases;
• When used 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.

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 rheumatoid 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 patient is unresponsive to at least 3 months of conservative medical therapy (i.e. non-steroidal anti-inflammatory medications, ice, rest and/or physical therapy); and
• The trial period is monitored and documented by a physician.

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

Utilization of electrodes is included in the monthly supplies and the separate billing of electrodes is considered unbundling. Normal utilization with a covered electrical stimulation device is:

• For 2 lead device, 4 electrodes per month
• For 4 lead device, 8 electrodes per month 

Implanted peripheral nerve stimulators may be considered medically necessary when used to alleviate chronic intractable neurogenic pain when ALL of the following criteria are met:

• The chronic intractable neurogenic pain is refractory to other methods of treatment (e.g., analgesics, physical therapy, local injection, surgery), and
• There is objective evidence of nerve injury or disease pathology (e.g., electromyography), and
• There is no psychological contraindication to peripheral nerve stimulation, and
• There is no addiction to drugs (per American Society of Addiction Medicine [ASAM guidelines), and
• A trial of transcutaneous stimulation was successful (resulting in at least a 50% reduction in pain).

The use of peripheral nerve stimulation for post-herpetic neuralgia and for all other indications is considered experimental /investigational.  Scientific evidence does not support the use of peripheral nerve stimulation other than the indications as stated above.

The StimRouter, also known as subcutaneous target stimulation, peripheral subcutaneous field stimulation (PSFS), or peripheral nerve field stimulation (PNFS) is considered experimental/investigational for the treatment of chronic pain of peripheral nerves, and therefore, non-covered. There is a lack of scientific literature to support the efficacy of this device.

The percutaneous or open (via incisions) implantation of a phrenic nerve stimulator is intended to be an alternative option in the management of patients with chronic respiratory insufficiency who are dependent upon a mechanical ventilator.

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  not covered. Scientific evidence does not support the use of phrenic nerve stimulation other than the above indications as stated above.

The implantation of a vagus (vagal) nerve stimulator for seizure control may be considered medically necessary only when used as a last resort for patients 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. 

Implantable Hypoglossal Nerve Stimulators

Refer to Medical Policy Bulletin Z-8 Diagnosis and Treatment of Obstructive Sleep Apnea for implantable hypoglossal nerve stimulators (64999). 

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.

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.

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

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.

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.

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.

Quantity level limits or quantity of supplies that exceed the frequency guidelines listed on the policy will be denied as non-covered. A network provider cannot bill the member for the non-covered service.

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

• Link to Provider Resource Center for the Medical Policy Update

04/2016- HF10 Spinal Cord Stimulation Therapy Considered Experimental/Investigational
08/2016- Criteria Established for HF 10 Spinal Cord Stimulation Therapy

• Link to Diagnosis Codes

• Link to Table Attachment(s)

• Link to References