Point32 Implantable Neurostimulators(Eff. beginning 1.1.24) Form

Implantable Neurostimulators

Implantable neurostimulators are micro-electronic devices that deliver stimulation to the nervous system and offer various therapeutic treatment options.

Deep Brain Stimulation (DBS)

DBS involves constant, high-frequency electrical stimulation of specific sites in the brain with implanted electrodes as a means to reduce the symptoms of movement disorders such as essential tremor and Parkinson’s disease.

Gastric Electrical Stimulation (GES) Therapy

GES therapy is a treatment for individuals with chronic gastroparesis, a gastrointestinal motility disorder characterized by delayed gastric emptying without evidence of physical obstruction. The implanted stimulator delivers electrical impulses to the gastric muscles to stimulate gastric myoelectric activity, which improves stomach emptying and reduces the frequency and severity of symptoms.

Sacral Nerve Stimulation

Sacral nerve stimulation has been recently introduced as an alternative, minimally invasive treatment option for individuals with chronic, severe fecal incontinence who fail first-line conservative therapies or who are not appropriate candidates for such therapies, and who are considering a more invasive surgical option.

Spinal Cord Stimulation (SCS)

SCS involves the electrical stimulation of spinal nerves using electrodes implanted in the epidural space of the spinal column. The goal of SCS is to suppress pain in specific areas for individuals with chronic pain, including chronic, refractory, neuropathic pain.

Vagus Nerve Stimulation (VNS)

VNS is a therapy for treatment-resistant major depression and bipolar disorder in which an implanted generator, the neurocybernetic prosthesis, delivers electrical pulses to the cervical portion of the vagus nerve. The goal of VNS is to reduce the severity and/or duration of a depressive period.

Coverage Determinations Guidance

The Plan uses guidance from the Centers for Medicare and Medicaid Services (CMS) for coverage determinations for its Medicare Advantage plan members. CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs), and documentation included in the Medicare manuals are the basis for coverage determinations.

For Tufts Health One Care plan members, the following NCDs are being used:

• Stereotactic Introduction, Subcortical Electrodes- and Spinal Cord Stimulator Insertion: NCD - Electrical Nerve Stimulators (160.7) (cms.gov)
• Sacral Nerve Stimulation for Urinary Incontinence: NCD - Sacral Nerve Stimulation For Urinary Incontinence (230.18) (cms.gov)
• Vagus Nerve Stimulation: NCD - Vagus Nerve Stimulation (VNS) (160.18) (cms.gov)

Gastric Stimulation

For the service of gastric stimulation, evidence is sufficient for coverage for gastroparesis. Gastric stimulation is a treatment modality to be considered for Members when all other treatment options have been tried, failed, or are ineffective for gastroparesis. See InterQual criteria.

Sacral Nerve for Fecal Incontinence

For the service of sacral nerve for fecal incontinence, evidence is sufficient for coverage. Members with a variety of prior surgical histories, disease, and injuries or lesions to the central nervous systems may be candidates for this treatment. Sacral nerve stimulation is endorsed by the American Society of Colon and Rectal Surgeons for Members as a treatment option for fecal incontinence. See criteria below.

The use of this criteria in the utilization management process will ensure access to evidence-based clinically appropriate care. See References section below for all evidence accessed in the development of these criteria.

Clinical Guideline Coverage Criteria

The Plan requires the use of the following InterQual® Subsets or SmartSheets to obtain prior authorization for the following implantable neurostimulator services:

1. Gastric Stimulation
2. Stereotactic Introduction, Subcortical Electrodes:
   • Stereotactic Introduction Cortical Electrodes
   • Stereotactic Introduction Subcortical Electrodesi.

Note:

The Plan covers subcortical electrodes for Members ages 7 and older when InterQual criteria for primary dystonia are met.

Spinal Cord Stimulator Insertion

1. Spinal Cord Temporary Electrode Trial
2. Spinal Cord Stimulator Insertion

Implantable Neurostimulators

In addition, The Plan considers implantable neurostimulators as reasonable and medically necessary with a request from an accredited provider with appropriate state licensure and when documentation confirms specific criteria for ANY of the following devices:

Sacral Nerve Stimulators for Urinary Incontinence: Temporary Trial

The Plan considers a temporary trial of sacral nerve stimulators as reasonable and medically necessary for the treatment of urinary incontinence or frequency with an external stimulator for either percutaneous nerve evaluation or an implanted lead, when documentation confirms ALL the following:

1. Diagnosis of urinary urgency with or without incontinence, urinary urgency associated with frequency and/or nocturia in the absence of infection or other pathology, OR non-obstructive urinary retention unrelated to a neurologic condition; and
2. Documented failure of, or symptoms refractory to, at least two types of conservative therapies, (e.g., behavioral interventions, dietary modifications, bladder training, trial of anticholinergic or beta agonist medications); and
3. Urinary incontinence is experienced for a minimum of 12 months and is not related to other neurologic conditions that is associated with secondary manifestations of urinary urge incontinence, urgency, frequency, or non-obstructive urinary retention.

Sacral Nerve Stimulators for Urinary Incontinence: Permanent

The Plan considers a permanent sacral nerve stimulators as reasonable and medically necessary for the treatment of urinary incontinence or frequency when documentation confirms member meets criteria for temporary trial of sacral nerve stimulators for urinary incontinence and has undergone a successful trial based on ALL the following:

1. Member has at least a 50% reduction in catheter volume/catheterization.
2. Member has at least 50% reduction in ONE of the following:
   • Daily incontinence episodes; or
   • Severity of the episodes or the number of pads/diapers used per day
3. Member has at least 50% improvement in ONE of the following:
   • Number of voids daily; or
   • Volume per void; or
   • Frequency per void

Sacral Nerve Stimulators for Fecal Incontinence: Temporary Trial

The Plan considers a temporary trial of sacral nerve stimulators is considered reasonable and medically necessary for the treatment of fecal incontinence when documentation confirms ALL the following:

1. More than 2 episodes of fecal incontinence per week for 6 consecutive months, or for 12 consecutive months following vaginal childbirth; and
2. Incontinence is not related to another neurologic condition (e.g., peripheral neuropathy, spinal cord injury); and
3. Documented failure of conservative therapies for at least 12 months, (e.g., medication, dietary modification), or symptoms or refractory to conservative therapies.

Sacral Nerve Stimulators for Fecal Incontinence: Permanent

The Plan considers a permanent sacral nerve stimulators are considered reasonable and medically necessary for the treatment of fecal incontinence when documentation confirms member meets criteria for temporary trial of sacral nerve stimulators for fecal incontinence and has undergone a successful trial of at least 50% improvement in symptoms.

Vagus Nerve Stimulator

The plan considers vagal nerve stimulators as reasonable and medically necessary when documentation confirms ALL the following:

1. Member with refractory seizures experiences persistent seizures and/or intolerable side effects after trials of 2 or more antiepileptic medications; and

Member has failed, or is not a candidate for, resective surgery

*For these services, prior authorization for Harvard Pilgrim Health Care Commercial Members must be submitted through the automated authorization questionnaire via HPHConnect at www.harvardpilgrim.org/providerportal. For Tufts Health Plan Commercial and Public Plan Members please submit prior authorization to the following Fax numbers:

• Tufts Health Plan Commercial: 617-972-9409
• Tufts Health Direct: 888-415-9055
• Tufts Health Together: 888-415-9055
• Tufts Health RITogether: 857-304-6404
• Tufts Health One Care: 857-304-6304

Note: For non-implantable percutaneous tibial nerve stimulation for voiding dysfunction please see the Percutaneous Tibial Nerve Stimulation for Voiding Dysfunction Medical Necessity Guideline. For hypoglossal nerve stimulation for the treatment of obstructive sleep apnea see the Surgical Procedures for Obstructive Sleep Apnea Medical Necessity Guidelines.

Limitations

The Plan considers Implantable Neurostimulators as not medically necessary for all other indications. In addition, The Plan does not cover:

1. Subcortical/Cortical Electrodes and Deep Brain stimulation for conditions including, but not limited to:
   • a. Chronic Cluster headache
   • b. Degenerative disorders
   • c. Depression
   • d. Drug-induced movement disorder (e.g., Tardive Dyskinesia)
   • e. Multiple Sclerosis (MS)
   • f. Obsessive-Compulsive Disorder (OCD)
   • g. Trauma
2. Gastric stimulation for any other indication, including obesity
3. Sacral nerve stimulation for conditions including, but not limited to:
   • a. Anorectal malformation
   • b. Chronic inflammatory bowel disease
   • c. Chronic pelvic pain
   • d. Constipationi.
   • e. Fecal incontinence following non-cancer related rectal surgery within the past 12 months, or cancer-related rectal surgery within the past 24 monthsii.
   • f. Stress incontinence or other chronic voiding dysfunction due to neurologic conditions (e.g., spinal cord injury, diabetic neuropathy, MSiii.)
   • g. Urge incontinence due to a neurologic condition (e.g., detrusor hyperreflexia)
4. Spinal nerve stimulation for conditions including, but not limited to:
   • a. Refractory Canadian Class III or IV Angina
   • b. Pain associated with malignancy
   • c. Treatment of critical limb ischemia
   • d. Cancer-related pain
   • e. Heart failure
   • f. Diabetic Neuropathy
   • g. Chronic Intractable Back Pain with Prior Spine Surgery
5. Vagus stimulation for conditions including, but not limited to:
   • a. Addictions
   • b. Alzheimer's disease
   • c. Anxiety disorder
   • d. Asthma
   • e. Autism spectrum disorder
   • f. Back and neck pain
   • g. Bipolar disorder
   • h. Bulimia
   • i. Cerebral palsy
   • j. Crohn’s Disease
   • k. Chronic pain syndrome
   • l. Cluster headaches
   • m. Depression
   • n. Essential tremor
   • o. Fibromyalgia
   • p. Heart failure
   • q. Migraines
   • r. Morbid obesity
   • s. Narcolepsy
   • t. Obsessive-compulsive disorder
   • u. Paralysis agitans
   • v. Sleep disorders
   • w. Tinnitus
   • x. Traumatic brain injury
   • y. Tourette's syndrome
6. Cerebellar stimulation/pacing for any indication
7. Occipital nerve stimulation for any indication
8. gammaCore®
9. Peripheral Nerve Stimulation for any indication