Neurostimulators Form

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Neurostimulators - Medical Policy
Updated Revision Effective: 6/1/2025 Policy Number:

UM1034POL

Approval Date: 3/11/2025

Line(s) of Business: Commercial
Medicare Advantage
Medicaid (BeHealthy)

Description

Spinal cord stimulation (SCS), also called dorsal column stimulation, involves the use of low-level epidural electrical stimulation of the spinal cord dorsal columns to block the sensation of pain. The neurophysiology of pain relief after SCS is uncertain but may be related to either activation of an inhibitory system or to blockage of facilitative circuits. SCS has been used in a wide variety of chronic refractory pain conditions, including pain associated with cancer, failed back pain syndromes, arachnoiditis, and complex regional pain syndrome (i.e., chronic reflex sympathetic dystrophy). There has also been interest in SCS as a treatment of critical limb ischemia, primarily in individuals who are poor candidates for revascularization and in individuals with refractory chest pain.

Spinal cord stimulation devices consist of several components: 1) the lead that delivers the electrical stimulation to the spinal cord, 2) an extension wire that conducts the electrical stimulation from the power source to the lead, and 3) a power source that generates the electrical stimulation. The lead may incorporate from four to eight electrodes, with eight electrodes more commonly used for complex pain patterns. There are two basic types of power source. In one type, the power source (battery) can be surgically implanted or worn externally with an antenna over the receiver. In the other, a radiofrequency receiver is implanted. Totally implantable systems are most commonly used.

The procedure initially involves a short-term trial (i.e., greater than 48 hours) of percutaneous (temporary) spinal cord stimulation, prior to the subcutaneous (permanent) implantation of the spinal cord stimulation device, to determine whether the spinal cord stimulator device will induce sufficient pain relief to render it medically necessary. Although it may vary depending on the specific device, a traditional dorsal column stimulator (i.e., non- high frequency) generally produces a pulse width between 20-1000 µs and frequencies between 2 and 1200 Hz. Some devices allow adjustment of the settings, including burst- and/or continuous-mode stimulation.

Other neurostimulators target the dorsal root ganglion, which consists of sensory cell bodies that transmit input from the peripheral nervous system to the central nervous system and play a role in neuropathic pain perception. Dorsal root ganglia are located in the epidural space between spinal nerves and the spinal cord on the posterior root in a minimal amount of cerebrospinal fluid, amenable to epidural access.

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Dorsal root ganglion (DRG) stimulation is an emerging method of treatment for neuropathic pain. With DRG, stimulation leads are placed percutaneously into the epidural space under fluoroscopic guidance directly over the targeted dorsal root ganglion within the lumbar or sacral region of the spine. Similar to spinal cord stimulation, a short-term trial (i.e., greater than 48 hours) is recommended using an external pulse generator; upon success of the trial a permanent pulse generator may then be implanted.

Deep Brain Stimulation (DBS) is an elective surgical procedure in which electrodes are implanted into certain brain areas. These electrodes, or leads, generate electrical impulses that control abnormal brain activity. The electrical impulses can also adjust for the chemical imbalances within the brain that cause various conditions. Stimulation of brain areas is controlled by a programmable generator that is placed under the skin in the upper chest.

The DBS system involves three distinct components:  The electrode, or lead, is a thin, insulated wire inserted through a small opening in the skull and implanted into a specific brain area.  The extension wire is also insulated and passed under the skin of the head, neck and shoulder, connecting the electrode to the internal pulse generator (IPG).  The IPG is the third piece of the system and is usually implanted under the skin in the upper chest. DBS is a surgical intervention used to treat patients with movement disorders such as essential tremor, Parkinson’s disease and dystonia. It can also be used to control symptoms of obsessive-compulsive disorder and epilepsy. This procedure is utilized when medications are no longer effective for patients maintaining good quality of life. These diseases affect hundreds of thousands of people worldwide. DBS has been used to treat over 160,000 people for various neurological conditions. Responsive Cortical Stimulation (Closed-Loop Implantable Neurostimulator) The RNS® System is intended to detect abnormal electrical brain signals that precede seizures and deliver electrical stimulation in response to try to normalize electrical brain activity and prevent seizures. The device includes a neurostimulator that is placed in the skull and leads that are placed in the seizure-originating areas of the brain. The system’s intended benefits include seizure prevention, fewer adverse events than other neurostimulation methods, and data transmission from the individual’s home to clinicians.

Sacral nerve stimulation (SNS), also referred to as sacral nerve neuromodulation (SNM), involves the implantation of a permanent device that modulates the neural pathways controlling bladder or rectal function. This policy addresses use of SNS in the treatment of urinary or fecal incontinence, fecal nonobstructive retention, and chronic pelvic pain in patients with intact neural innervation of the bladder and/or rectum.

Urge incontinence is defined as leakage of urine when there is a strong urge to void. Urgency frequency is an uncontrollable urge to urinate, resulting in very frequent, small volumes. Urgency frequency is a prominent symptom of interstitial cystitis (also called bladder pain syndrome.) Urinary retention is the inability to completely empty the bladder of urine. Fecal incontinence can arise from a variety of mechanisms, including rectal wall compliance, efferent and afferent neural pathways, central and peripheral nervous systems, and voluntary and involuntary muscles. Fecal incontinence is more common in women (female assigned at birth), due mainly to muscular and neural damage that may occur during vaginal delivery.

Sacral nerve stimulation treatment is one of several alternative modalities for individuals with urinary or fecal incontinence (urge incontinence, significant symptoms of urgency-frequency, nonobstructive urinary retention) who have failed behavioral (eg, prompted voiding) and/or pharmacologic therapies.

Percutaneous tibial nerve stimulation (PTNS); also known as posterior tibial nerve stimulation) is a technique of electrical neuromodulation used primarily for the treatment of voiding dysfunction in individuals who have failed

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behavioral therapies and/or pharmacologic therapies. Voiding dysfunction includes urinary frequency, urgency, incontinence and nonobstructive retention. Common causes of non-neurogenic voiding dysfunction are pelvic floor neuromuscular changes (from pregnancy, childbirth, surgery, etc.), inflammation, medication side effects (e.g., diuretics and anticholinergics), obesity, and psychogenic factors. Overactive bladder is a non-neurogenic voiding dysfunction characterized by urinary frequency, urgency, urge incontinence, and nonobstructive retention.

Neurogenic bladder dysfunction is caused by neurologic damage in individuals with multiple sclerosis, spinal cord injury, detrusor hyperreflexia, or diabetes with peripheral nerve involvement. The symptoms include overflow incontinence, frequency, urgency, urge incontinence, and retention.

Approaches to the treatment of incontinence differentiate between urge incontinence and stress incontinence. Conservative behavioral management such as lifestyle modification (e.g., dietary changes, weight reduction, fluid management, smoking cessation) along with pelvic floor exercises and bladder training are part of the initial treatment of overactive bladder symptoms and both types of incontinence. Pharmacotherapy is another option, and different medications target different symptoms. Some individuals experience mixed incontinence.

If behavioral therapies and pharmacotherapy are unsuccessful, percutaneous tibial nerve stimulation (PTNS), sacral nerve stimulation, or botulinum toxin may be recommended.

Vagus Nerve Stimulation (VNS) is a pulse generator, similar to a pacemaker, that is surgically implanted under the skin of the left chest and an electrical lead (wire) is connected from the generator to the left vagus nerve. Electrical signals are sent from the battery-powered generator to the vagus nerve via the lead. These signals are in turn sent to the brain. The Food and Drug Administration (FDA) approved VNS for treatment of refractory epilepsy in 1997 and for resistant depression in 2005.

 Line of Business

Commercial:

Spinal Stimulation

 HNE has adopted InterQual* criteria for the following procedures:

o Spinal Cord Stimulator Temporary Electrode or Dorsal Root Ganglion Stimulation (DRGS) Trial: CP:Procedures, Spinal Cord Stimulator (SCS) Insertion, Spinal Cord Stimulator Temporary Electrode Trial. o Spinal Cord Stimulator (SCS) Insertion/ Dorsal Column Stimulator Insertion/ Dorsal Root Ganglion Stimulator Insertion: CP: Procedures, Spinal Cord Stimulator (SCS) Insertion, Spinal Cord Stimulator (SCS) Insertion.

Deep Brain and Cortical Stimulation

 HNE has adopted InterQual* criteria for the following procedures:

o Deep Brain Stimulation (DBS):

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Cortical Electrodes.

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 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Subcortical Electrodes.

o Intracranial Electrode Placement (Stereo-Electroencephalography (SEEG)):

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Cortical Electrodes.

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Subcortical Electrodes.

o Radiofrequency (RF) Lesioning:

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Cortical Electrodes.

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Subcortical Electrodes.

o Responsive Cortical Stimulation:

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Cortical Electrodes.

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Subcortical Electrodes.

Gastric Electrical Stimulation

 HNE has adopted InterQual* criteria for the following procedure:

o Enterra Therapy System: CP: Procedures, Gastric Stimulation.

o Gastric Pacemaker Insertion: CP: Procedures, Gastric Stimulation.

Sacral nerve stimulation

 Refer to criteria under the Policy section in this medical policy

Percutaneous tibial nerve stimulation

 Refer to criteria under the Policy section in this medical policy

Vagus Nerve stimulation

 HNE has adopted InterQual* criteria for the following procedures:

o CP: Procedures, Vagus Nerve Stimulation (VNS).

o CP: Procedures, Vagus Nerve Stimulation (VNS) (Pediatric).

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Medicaid – BeHealthy:

Spinal Stimulation

 HNE has adopted InterQual* criteria for the following procedures:

o Spinal Cord Stimulator Temporary Electrode or Dorsal Root Ganglion Stimulation (DRGS) Trial: CP: Procedures, Spinal Cord Stimulator (SCS) Insertion, Spinal Cord Stimulator Temporary Electrode Trial. o Spinal Cord Stimulator (SCS) Insertion/ Dorsal Column Stimulator Insertion/ Dorsal Root Ganglion Stimulator Insertion: CP: Procedures, Spinal Cord Stimulator (SCS) Insertion, Spinal Cord Stimulator (SCS) Insertion.

 There are no MassHealth guidelines for Spinal Cord and Dorsal Root Ganglion Stimulation.

Deep Brain and Cortical Stimulation

 HNE has adopted InterQual* criteria for the following procedures:

o Deep Brain Stimulation (DBS):

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Cortical Electrodes.

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Subcortical Electrodes.

o Intracranial Electrode Placement (Stereo-Electroencephalography (SEEG)):

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Cortical Electrodes.

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Subcortical Electrodes.

o Radiofrequency (RF) Lesioning:

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Cortical Electrodes.

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Subcortical Electrodes.

o Responsive Cortical Stimulation:

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Cortical Electrodes.

 CP: Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Subcortical Electrodes.

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Gastric Electrical Stimulation

 HNE has adopted InterQual* criteria for the following procedure:

o Enterra Therapy System: CP: Procedures, Gastric Stimulation.

o Gastric Pacemaker Insertion: CP: Procedures, Gastric Stimulation.

 There are no MassHealth guidelines for Gastric Electrical Stimulation

Sacral nerve stimulation

 Refer to criteria under the Policy section in this medical policy.

 There are no MassHealth guidelines for Sacral nerve stimulation for voiding dysfunction and Sacral nerve stimulation for fecal incontinence.

Percutaneous tibial nerve stimulation

 Refer to criteria under the Policy section in this medical policy.

 There are no MassHealth guidelines for Percutaneous tibial nerve stimulation.

Vagus Nerve stimulation

 HNE has adopted InterQual* criteria for the following procedures:

o CP: Procedures, Vagus Nerve Stimulation (VNS).

o CP: Procedures, Vagus Nerve Stimulation (VNS) (Pediatric).

 There are no MassHealth guidelines for Vagus Nerve Stimulation.

Medicare:

Spinal Stimulation

 Health New England follows National Coverage Determination 160.7 Electrical Nerve Stimulators. MCD Search (cms.gov)

Deep Brain and Cortical Stimulation

 For Deep Brain Stimulation (DBS) Health New England follows National Coverage Determination (NCD) 160.24, Deep Brain Stimulation for Essential Tremor and Parkinson’s disease for the Medicare line of business. https://www.cms.gov/medicare-coverage-database/search.aspx

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 HNE has adopted InterQual* criteria for the following procedures:

o Responsive Cortical Stimulation:

 CP:Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Cortical Electrodes.

 CP:Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Subcortical Electrodes.

Gastric Electrical Stimulation

 HNE has adopted InterQual* criteria for the following procedure:

o Enterra Therapy System: CP: Procedures, Gastric Stimulation.

o Gastric Pacemaker Insertion: CP: Procedures, Gastric Stimulation.

 Medicare does not have a National Coverage Determination (NCD) or a Local Coverage Determination (LCD) for Gastric Electrical Stimulation.

Sacral nerve stimulation

 For Sacral nerve stimulation for fecal incontinence refer to criteria under Policy section in this medical policy.

 Medicare does not have a National Coverage Determination (NCD) or a Local Coverage Determination (LCD) for sacral nerve stimulation for fecal incontinence.

 Health New England follows National Coverage Determination (NCD) or a Local Coverage Determination (LCD) found at MCD Search (cms.gov) for the following procedures: o Sacral nerve stimulation for voiding dysfunction: NCD 230.18 Sacral Nerve Stimulation for Urinary Incontinence.

Percutaneous tibial nerve stimulation

 Health New England follows National Coverage Determination (NCD) or a Local Coverage Determination (LCD) found at MCD Search (cms.gov) for the following procedures: o Percutaneous tibial nerve stimulation: LCD L33396 Posterior Tibial Nerve Stimulation for Voiding Dysfunction.

Vagus Nerve stimulation

 Health New England follows National Coverage Determination (NCD) or a Local Coverage Determination (LCD) found at MCD Search (cms.gov) for the following procedures: o Vagus nerve stimulation: NCD 160.18 Vagus Nerve Simulation.

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*To obtain InterQual® SmartSheets™: If you are a registered Health New England provider click here: https://www.hnedirect.com/login/ to access the Provider website. If you do not have access to the portal call (413) 787-4004 to obtain a copy.

Policy

Spinal Stimulation

I. Spinal Cord Stimulator Temporary Electrode or Dorsal Root Ganglion Stimulation (DRGS) Trial

A. HNE has adopted InterQual* criteria for the following procedures:

o CP: Procedures, Spinal Cord Stimulator (SCS) Insertion, Spinal Cord Stimulator Temporary Electrode Trial.

B. For members under 18 years of age, the request will be reviewed on a case-by-case basis.

C. Health New England follows National Coverage Determination 160.7 Electrical Nerve Stimulators for Medicare line of business.

D. Spinal Cord Stimulator Temporary Electrode or Dorsal Root Ganglion Stimulation (DRGS) Trial for all other indications other than in criteria above are considered NOT MEDICALLY NECESSARY.

II. Spinal Cord Stimulator (SCS) Insertion/ Dorsal Column Stimulator Insertion/ Dorsal Root Ganglion Stimulator Insertion

A. HNE has adopted InterQual* criteria for the following procedures:

o CP: Procedures, Spinal Cord Stimulator (SCS) Insertion, Spinal Cord Stimulator (SCS) Insertion.

B. For members under 18 years of age, the request will be reviewed on a case-by-case basis.

C. Health New England follows National Coverage Determination 160.7 Electrical Nerve Stimulators for Medicare line of business.

D. Spinal Cord Stimulator (SCS) Insertion/ Dorsal Column Stimulator Insertion/ Dorsal Root Ganglion Stimulator Insertion for all other indications other than in criteria above are considered NOT MEDICALLY NECESSARY.

III. Replacement of an existing cervical, lumbar or thoracic SCS or DRGS’s battery or generator is MEDICAL NECESSARY (for all lines of business) for individuals who meet the medical necessity criteria (II) above, have had a positive pain relief response and when the existing stimulator, battery or generator is malfunctioning, cannot be repaired, and is no longer under warranty. (Lead and electrode replacement will not be approved as are generally not required at the time of generator replacement due to end of battery life).

IV. Removal of a cervical, lumbar or thoracic SCS or DRG stimulator may be MEDICALLY NECESSARY for one or more of the following indications for ALL lines of business:

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A. Infection

1. Localized infection at the implant site (e.g., pocket site, lead site).
2. Systemic infection, such as sepsis or osteomyelitis.

3. Persistent infections despite antibiotic treatment.

   B. Device-Related Complications

4. Hardware migration: Leads or stimulator have moved from their intended position, leading to inadequate pain relief or side effects.
5. Lead fracture or malfunction: Leads are damaged or fail to deliver the stimulation properly.
6. Battery failure: Device no longer functions, and replacement is not preferred or feasible.

7. Erosion: The device or leads are eroding through the skin.

   C. Lack of Efficacy

8. Inadequate pain relief despite proper programming and troubleshooting.
9. Loss of therapeutic effect over time (tolerance or disease progression).

10. Pain in regions not covered by the device.

    D. Adverse Effects

11. New or worsening pain related to the device or its placement.
12. Neurological complications, such as weakness, numbness, or worsening sensory symptoms.

13. Overstimulation or uncomfortable paresthesia.

    E. Other Indications  Removal of Spinal cord stimulator or dorsal root ganglion stimulator for indications not listed above will be determined on case-by-case bases after review of treating provider’s detailed documentation supporting the removal.

    V. Spinal cord stimulation or dorsal root ganglion stimulation is considered EXPERIMENTAL and INVESTIGATIONAL for indications including but not limited to the following:

14. The use of cervical dorsal column stimulation for the treatment of members with cervical trauma, disc herniation, essential tremor, failed cervical spine surgery syndrome presenting with arm pain, neck pain, cervicogenic headache, gliomas, migraine, radiation-induced brain injury, stroke, trigeminal neuropathy, or any other indication (other than CRPS).
15. Treatment of critical limb ischemia as a technique to forestall amputation.
16. Treatment of refractory angina pectoris.
17. Treatment of nociceptive pain (pain resulting from irritation rather than damage to the nerves, i.e., inflammation, chemicals or physical events).
18. Treatment of visceral pain (abdominal or pelvic).
19. Treatment of cancer-related pain.
20. Treatment of central deafferentation pain (pain related to central nervous system damage from stroke or spinal cord surgery).
21. Treatment of heart failure.

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9. Dysesthesias involving the lower extremities secondary to spinal cord injury.
10. Dorsal root ganglion stimulators for treatment of chronic pelvic pain syndrome.
11. The concurrent use of two dorsal column stimulators for the treatment of complex regional pain syndrome or any other indications.

12. The combined use of dorsal column stimulation and dorsal root ganglion stimulation for the treatment of complex regional pain syndrome or any other indications.

    VI. Spinal cord stimulation or dorsal root ganglion stimulation is NOT COVERED under following circumstances due to relative or absolute contraindications:

13. Inability to control the device.
14. Uncontrolled bleeding disorder
15. Local or systemic sepsis.
16. An unresolved major psychiatric comorbidity.
17. An active and untreated substance abuse disorder.
18. Pregnancy.

19. Immunosuppression.

    Deep Brain and Cortical Stimulation

    I. Deep Brain Stimulation (DBS), Intracranial Electrode Placement (Stereo-Electroencephalography (SEEG)), Radiofrequency (RF) Lesioning, Responsive Cortical Stimulation

    A. HNE has adopted InterQual* criteria for the following procedures:

    o CP:Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Cortical Electrodes.

    o CP:Procedures, Stereotactic Introduction, Subcortical or Cortical Electrodes, Stereotactic Introduction, Subcortical Electrodes.

    B. For members under 18 years of age, the request will be reviewed on a case-by-case basis.

    C. For Medicare, for Deep Brain Stimulation (DBS) HNE follows National Coverage Determination (NCD) 160.24, Deep Brain Stimulation for Essential Tremor and Parkinson’s disease.

    D. Deep Brain Stimulation (DBS), Intracranial Electrode Placement (Stereo-Electroencephalography (SEEG)), Radiofrequency (RF) Lesioning, Responsive Cortical Stimulation for all other indications other than in criteria above are considered NOT MEDICALLY NECESSARY.

    Gastric Electrical Stimulation

    I. Gastric Electrical Stimulation (Enterra Therapy System and Gastric Pacemaker Insertion)

    A. Health New England has adopted following InterQual criteria.

    o CP: Procedures Gastric Stimulation.

    B. For members under 18 years of age, the request will be reviewed on a case-by-case basis.

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C. Revision or replacement of a previously approved gastric stimulator implant is MEDICALLY NECESSARY for complications associated with gastric pacing (e.g. bowel obstruction, gastric wall perforation, infection, lead dislodgement or lead erosion into the small intestine).

D. Gastric Electrical Stimulation for conditions that do not meet the above criteria is considered NOT MEDICALLY NECESSARY.

Sacral nerve stimulation for voiding dysfunction

I. Sacral nerve stimulation trial for voiding dysfunction with either percutaneous nerve stimulation or a temporarily implanted lead may be considered MEDICALLY NECESSARY in individuals who meet ALL of the following criteria:

A. 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 B. Documented failure of, or symptoms refractory to, at least two TYPES of conservative therapies, (e.g., behavioral interventions, dietary modifications, bladder training, trial of pharmacotherapy [e.g. anticholinergic or beta agonist medications]); AND C. 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; AND D. The individual is an appropriate surgical candidate.

II. Permanent implantation of a sacral nerve stimulation device for voiding dysfunction may be considered MEDICALLY NECESSARY in individuals who meet ALL of the following criteria:

A. All of the criteria above are met; AND

B. Member has at least a 50% reduction in catheter volume/catheterization OR member has at least 50% reduction in ONE of the following:

1. Daily incontinence episodes; or

2. Severity of the episodes or the number of pads/diapers used per day; AND

                         C. Member has at least 50% improvement in ONE of the following:

3. Number of voids daily; or
4. Volume per void; or

5. Frequency per void.

   III. Sacral nerve stimulation for other voiding dysfunctions other than those listed above are considered NOT MEDICALLY NECESSARY including but not limited to treatment of stress incontinence or urge incontinence due to a neurologic condition, (eg, detrusor hyperreflexia, multiple sclerosis, spinal cord injury, or other types of chronic voiding dysfunction).

   Sacral nerve stimulation for fecal incontinence

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I. Sacral nerve stimulation trial for fecal incontinence with either percutaneous nerve stimulation or a temporarily implanted lead may be considered MEDICALLY NECESSARY in individuals who meet ALL of the following criteria:

A. There is a diagnosis of chronic fecal incontinence of greater than two incontinent episodes on average per week with duration greater than 6 months or for more than 12 months after vaginal childbirth; AND

B. There is documented failure or intolerance of two or more conventional conservative therapy (e.g., dietary modification, the addition of bulking and pharmacologic treatment) for at least 12 months to fully assess its efficacy; AND

C. The condition is not related to an anorectal malformation (e.g., congenital anorectal malformation; defects of the external anal sphincter over 60 degrees; visible sequelae of pelvic radiation; active anal abscesses and fistulae) or chronic inflammatory bowel disease; AND

D. Stress incontinence or other chronic voiding dysfunction is not due to neurologic conditions such as spinal cord injury, diabetic neuropathy, Multiple Sclerosis, etc. or urge incontinence is not due to a neurologic condition such as detrusor hyperreflexia; AND

E. The individual has not had rectal surgery in the previous 12 months, or in the case of cancer, the individual has not had rectal surgery in the past 24 months.

F. The individual is an appropriate surgical candidate.

II. Permanent implantation of a sacral nerve stimulation device for fecal incontinence may be considered MEDICALLY NECESSARY in individuals who meet ALL of the following criteria:

A. All of the criteria above are met; AND

B. A trial stimulation period demonstrates at least 50% improvement in symptoms over a period of at least 48 hours.

III. Sacral nerve stimulation for indications other than those listed above are considered NOT MEDICALLY NECESSARY including for treatment of chronic constipation or chronic pelvic pain.

IV. Sacral nerve stimulation for conditions including, but not limited to the following care considered NOT MEDICALL NECESSARY:

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A. Anorectal malformation
B. Chronic inflammatory bowel disease
C. Chronic pelvic pain
D. Constipation.

Percutaneous tibial nerve stimulation (PTNS)

I. Percutaneous tibial nerve stimulation may be considered MEDICALLY NECESSARY when ALL of the following criteria are met:

A. A specialist (e.g., urologist or urogynecologist) confirms that the member is a good candidate for PTNS with documentation that supports the need for PTNS therapy initiation; AND

B. Symptoms of non-neurogenic urinary dysfunction including overactive bladder (e.g., urinary urgency, frequency, urge incontinence) for at least 12 months duration; AND

C. There is documented failure or intolerance of two or more non-pharmacologic behavioral therapies (e.g., pelvic floor muscle training, biofeedback, timed voids and/or fluid management) of at least 8 to 12 weeks to control symptoms; AND

D. Failure, contraindication, or intolerance to two appropriate medications (e.g., pharmacotherapy with alpha blockers and cholinergic) for at least 4 weeks duration prior to the PTNS therapy.

II. If above criteria are met, a total of 12 treatments (one per week) will be initially approved.

III. Maintenance therapy using monthly percutaneous tibial nerve stimulation for an additional one year is considered medically necessary following a 12-week initial course of percutaneous tibial nerve stimulation that resulted in improved urinary dysfunction meeting treatment goals.

IV. Percutaneous tibial nerve stimulation is considered EXPERIMENTAL and INVESTIGATIONAL for all
other indications, including but not limited to neurogenic bladder dysfunction and fecal incontinence.

V. Criteria for Approval of Sacral Nerve Stimulation and Percutaneous Tibial Nerve Stimulation (PTNS) for Medicare.

 Health New England follows National Coverage Determination (NCD) for Sacral Nerve Stimulation for Urinary Incontinence (230.18).

                  NCD - Sacral Nerve Stimulation For Urinary Incontinence (230.18) (cms.gov)

 Health New England follows Local Coverage Determination (NCD) for Posterior Tibial Nerve Stimulation for Voiding Dysfunction (L33396)

                  LCD - Posterior Tibial Nerve Stimulation for Voiding Dysfunction (L33396) (cms.gov)

Vagus Nerve Stimulation

I. HNE has adopted InterQual* criteria for the following procedures:

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o CP:Procedures, Vagus Nerve Stimulation (VNS).

o CP:Procedures, Vagus Nerve Stimulation (VNS) (Pediatric).

II. Health New England follows National Coverage Determination (NCD) for Vagus Nerve Simulation (160.18)

NCD - Vagus Nerve Stimulation (VNS) (160.18)

III. Vagus nerve stimulation for all other indications other than in criteria above are considered NOT MEDICALLY NECESSARY.

Coding Guidance

Codes for Spinal stimulation

CPT Codes

Prior Auth 63650 Percutaneous implantation of neurostimulator electrode array, epidural YES 63655 Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural YES 63663 Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed YES 63664 Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed YES 63685 Insertion or replacement of spinal neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver YES 63688 Revision or removal of implanted spinal neurostimulator pulse generator or receiver, with detachable connection to electrode array YES 64553 Percutaneous implantation of neurostimulator electrode array; cranial nerve (For trial) YES

Codes for Deep Brain and Cortical Stimulation

Code
Description
PA 61720 Creation of lesion by stereotactic method, including burr hole(s) and localizing and recording techniques, single or multiple stages; globus pallidus or thalamus
YES

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Code
Description
PA 61850 Twist drill or burr hole(s) for implantation of neurostimulator electrodes, cortical
YES 61860 Craniectomy or craniotomy for implantation of neurostimulator electrodes, cerebral, cortical
YES 61863 Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (e.g., thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), without use of intraoperative microelectrode recording YES 61864 each additional array (List separately in addition to primary procedure) NO 61867 Twist drill, burr hole, craniotomy, or craniectomy with stereotactic implantation of neurostimulator electrode array in subcortical site (e.g., thalamus, globus pallidus, subthalamic nucleus, periventricular, periaqueductal gray), with use of intraoperative microelectrode recording; first array YES 61880 Revision or removal of intracranial neurostimulator electrodes YES 61885 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array YES 61886 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array with connection to 2 or more electrode arrays YES 61889 Insertion of skull-mounted cranial neurostimulator pulse generator or receiver, including craniectomy or craniotomy, when performed, with direct or inductive coupling, with connection to depth and/or cortical strip electrode array(s) YES 61891 Revision or replacement of skull-mounted cranial neurostimulator pulse generator or receiver with connection to depth and/or cortical strip electrode array(s) YES

Gastric Electrical Stimulation

Code
Description PA 43647 Laparoscopy, surgical; implantation or replacement of gastric neurostimulator electrodes, antrum
Yes 43648 Laparoscopy, surgical; revision or removal of gastric neurostimulator electrodes, antrum
Yes 43881 Implantation or replacement of gastric neurostimulator electrodes, antrum, open
Yes 43882 Revision or removal of gastric neurostimulator electrodes, antrum, open
Yes 64590 Insertion or replacement of peripheral or gastric neurostimulator pulse generator or receiver, direct or inductive coupling Yes 64595 Revision or removal of peripheral or gastric neurostimulator pulse generator or receiver
Yes 95980 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient measurements) gastric neurostimulator pulse generator/transmitter; intraoperative, with programming No 95981 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient measurements) gastric neurostimulator pulse generator/transmitter; subsequent, without reprogramming No 95982 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude and duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient measurements) gastric neurostimulator pulse generator/transmitter; subsequent, with reprogramming No

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Codes for Sacral Nerve Stimulation for Urinary or Fecal Incontinence Temporary Trial

CPT Codes

Prior Auth 64561 Sacral nerve (transforaminal placement) including image guidance, if performed YES 64581 Sacral nerve transforaminal placement YES A4290 Sacral nerve stimulation test lead, each Yes

Codes for Sacral Nerve Stimulation for Urinary or Fecal Incontinence Permanent Placement

CPT Codes

Prior Auth 64561 Sacral nerve (transforaminal placement) including image guidance, if performed YES 64581 Sacral nerve transforaminal placement YES 64590 Insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver. YES 64595 Revision or removal or peripheral, sacral, or gastric neurostimulator pulse generator or receiver, with detachable connection to electrode array. YES

Codes for Posterior Tibial Neurostimulation

CPT Code

Prior Auth 64561 Percutaneous implantation of neurostimulator electrode array; sacral nerve (transforaminal placement) including image guidance, if performed YES 64566 Posterior tibial neurostimulation, percutaneous needle electrode, single treatment, includes programming YES

Codes for Vagus Nerve Stimulation

CPT Code

Prior Auth 61885 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to a single electrode array YES 61886 Insertion or replacement of cranial neurostimulator pulse generator or receiver, direct or inductive coupling; with connection to 2 or more electrode arrays YES 61888 Revision or removal of cranial neurostimulator pulse generator or receiver YES 64553 Percutaneous implantation of neurostimulator electrode array; cranial nerve YES 64568 Open implantation of cranial nerve (eg, vagus nerve) neurostimulator electrode array and pulse generator YES

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HPCS Codes

CPT® Copyright 2025 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all-inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

References

Spinal stimulation

National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7).
NCD - Electrical Nerve Stimulators (160.7) (cms.gov)

Deep Brain and Cortical Stimulation

CMS National Coverage Determination (NCD) 160.24, Deep Brain Stimulation for Essential Tremor and Parkinson’s disease. https://www.cms.gov/medicare-coverage-database/search.aspx Code Description Prior Auth A4290 Sacral nerve stimulation test lead, eac YES L8680 Implantable neurostimulator electrode, each YES L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator NO L8682 Implantable neurostimulator radiofrequency receiver YES L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver YES L8685 Implantable neurostimulator pulse generator, single array, rechargeable, includes extension YES L8686 Implantable neurostimulator pulse generator, single array, non- rechargeable, includes extension YES L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension YES

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Two-year seizure reduction in adults with medically intractable partial onset epilepsy treated with responsive neurostimulation: final results of the RNS System Pivotal trial. Heck et al., Epilepsia 2014, 55: 432-41. https://pubmed.ncbi.nlm.nih.gov/24621228/ Deep brain and cortical stimulation for epilepsy. Sprengers et al., Cochrane Database Syst Rev 2017, 7: CD008497. https://pubmed.ncbi.nlm.nih.gov/28718878/

Sacral Nerve Stimulation and Percutaneous Tibial Nerve Stimulation

Local Coverage Determination (NCD) for Posterior Tibial Nerve Stimulation for Voiding Dysfunction (L33396). LCD - Posterior Tibial Nerve Stimulation for Voiding Dysfunction (L33396)

Gaziev, G., Topazio, L., Iacovelli, V., Asimakopoulos, A., & DiSanto, A. (2013, November 25). Percutaneous tibial nerve stimulation (PTNS) efficacy in the treatment of lower urinary tract dysfunctions: A systematic review.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4222591/

PMID: 24274173

De Wall, L. L., & Heesakkers, J. P. (2017, August 14). Effectiveness of percutaneous tibial nerve stimulation in the treatment of overactive bladder syndrome.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5565382/

PMID: 28861404

Gupta, P, Ehlert, M, Sirls, L, Peters, K, (published January 29, 2015), Percutaneous Tibial Nerve Stimulation and Sacral Neuromodulation: an Update.
https://link.springer.com/article/10.1007/s11934-014-0479-1

Lightner DJ, Gomelsky A, Souter L et al, Diagnosis and Treatment of Non-Neurogenic Overactive Bladder (OAB) in Adults: an AUA/SUFU Guideline (2019), American Urological Association.

  https://www.auanet.org/guidelines/guidelines/overactive-bladder-(oab)-guideline

Siegel S, Noblett K, Mangel J et al. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared withstandard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn 2014.

Rao SS; American College of Gastroenterology Practice Parameters Committee. Diagnosis and management of fecal incontinence. American College of Gastroenterology Practice Parameters Committee. Am J Gastroenterol 2004; 99(8):1585-604.

Percutaneous Tibial Nerve Stimulation for the Treatment of Symptomatic Neurogenic Lower Urinary Tract Dysfunction. (2019, April 15).

   https://evidence.hayesinc.com/report/dir.tibialnerve4533

(Subscription required)

Schmidt, R. A., Jonas, U., Oleson, K. A., Janknegt, R. A., & Hassouna, M. M. (1999, August). Sacral nerve stimulation for treatment of refractory urinary urge incontinence. The Journal of Urology/ Urology Practice.

https://www.auajournals.org/doi/10.1016/S0022-5347(05)68558-8

Tubaro, A., Puccini, F., & DeNunzio, C. (2015, July 25). The management of overactive bladder: Percutaneous tibial nerve stimulation, sacral nerve stimulation, or botulinum toxin?

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https://www.ncbi.nlm.nih.gov/pubmed/26049873

PMID: 26049873

Comparative effectiveness review of percutaneous tibial nerve stimulation for the treatment of symptomatic non-neurogenic overactive bladder (Annual review November 15, 2022).

  https://evidence.hayesinc.com/report/dir.percutaneous1251

(Subscription required)

Vagus Nerve Stimulation

National Coverage Determination (NCD) Vagus Nerve Simulation (160.18) NCD - Vagus Nerve Stimulation (VNS) (160.18)

Policy Implementation

Approved by the Medical and Pharmacy Policy Committee

Kate McIntosh MD MBA

Chief Medical Officer

Saad Usmani MD MBA

Medical Director

Date Update 12/2024  New Policy Effective 4/1/2024.  Replaces Spinal Cord and Dorsal Root Ganglion Stimulation and Sacral Nerve Stimulation and Percutaneous Tibial Nerve Stimulation Medical Policies  This policy encapsulates Spinal stimulation, Sacral nerve stimulation, Percutaneous tibial nerve stimulation and Vagus nerve stimulation. 2/2025  Deep Brain and Cortical Stimulation and Gastric Electrical Stimulation criteria added to the policy.  Name of policy changed from Implantable Neurostimulaors to Neurostimulators.

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion

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that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.