Medical Policy: 07.01.61 

Original Effective Date: November 2000 

Reviewed: August 2017 

Revised: August 2017 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Spinal cord stimulation (SCS), also known as dorsal column stimulator (DCS) involves the use of low-level epidural electrical stimulation of the dorsal columns of the spinal cord 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 blockage of facilitative circuits. SCS is the most commonly used implantable neurostimulation technology for the management of pain syndromes.

 

SCS is used for the treatment of pain that is neuropathic in nature, i.e. resulting from damage to the peripheral nerves. SCS has been used in a wide variety of chronic refractory pain conditions, including but are not limited to failed back syndrome, complex regional pain syndrome (i.e. reflex sympathetic dystrophy), arachnoiditis (usually documented by the presence of high levels of proteins in the cerebrospinal fluid and/or by myelography or MRI), radiculopathies, phantom limb/stump pain and peripheral neuropathy. There has been an interest in SCS as a treatment of critical limb ischemia, primarily in patients who are poor candidates for revascularization, pain associated with cancer and in patients with refractory chest pain.

 

Spinal cord stimulation (SCS) devices consists 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 4 to 8 electrodes, with 8 electrodes more commonly used for complex pain patterns.  The patient’s pain distribution pattern dictates at what level in the spinal cord the stimulation lead is placed. The pain pattern may influence the type of device used; for example, a lead with 8 electrodes may be selected for those with complex pain patterns or bilateral pain. Totally implantable systems are the most commonly used.

 

Traditional spinal cord stimulation devices use electrical stimulation with a frequency on the order of 100 to 1000 HZ. Some devices allow adjustment of the frequency settings. In 2015 a spinal cord stimulation device using a higher frequency (10,000 Hz) was approved by the FDA through the premarket approval process. The high-frequency stimulation is proposed to be associated with fewer paresthesias, which are a recognized effect of traditional spinal cord stimulation devices.

 

Types of Spinal Cord Stimulation Devices

  • Conventional Systems: (total implantable system): The leads are inserted in the epidural space above the spinal cord using a small needle or through a small incision. The exact location of the lead(s) depends on the specificity of the patients pain. The generator is usually implanted in the abdomen or buttock region. This system requires little effort on the patient’s part for maintenance. However, a minor surgical procedure is required to replace the power source when it runs out.
  • Radiofrequency Systems: Are designed to sustain therapy over long periods at the highest output level. Because of its high power capabilities, the RF system is suitable for the most challenging cases in which there is complex, multi-extremity pain. With this type of system, the patient must wear an external power source to activate stimulation.
  • Rechargeable Systems: Are the newest type of SCS device. The patient is responsible for recharging the power source when it runs low. A rechargeable system typically lasts longer than a conventional System. Eventually a minor surgical procedure may be required to replace the power source if the time between recharges becomes impractical.

Patients being considered for spinal cord stimulation should ideally meet the following criteria:

  • Pain is not associated with malignancy
  • Poor response to conservative treatment for a minimum of 6 months
  • Revision surgery not an option or would have a low chance of success
  • No pacemaker or other medical contraindications
  • No major psychiatric disorders, including somatization
  • Willingness to stop inappropriate drug usage prior to implantation
  • Ability to give informed consent for the procedure 

Spinal cord stimulation is used only as a last resort; other treatment modalities (pharmacological, surgical, psychological or physical, if applicable) have been tried and failed or are judged to be unsuitable or contraindicated.

 

Implantation of the spinal cord stimulator device is typically a 2 step process:

 

Spinal Cord Stimulator Trial

The first step is to implant a device on a trial basis which is done in an outpatient visit. The patient’s skin is numbed with a local anesthetic; leads are placed under the skin and attached to a small generator that the patient carries (much like a pager or cell phone); and using pre-set programs, electrical  currents are emitted in a pattern to target the areas of pain. The trial phase can be beneficial for the following reasons:

  • It can help the patient/physician analyze whether SCS effectively relieves pain.
  • It provides the patient/physician with an assessment period to determine which types of SCS technology works best.
  • It enables the patient/physician to evaluate different stimulation settings and programs.

The individual will keep a written log of the stimulation settings during different activities, along with the level of pain relief. If the trial is successful (reduction in pain of at least 50% or more) then a permanent spinal cord stimulator may be implanted. 

 

Permanent Spinal Cord Stimulator

If the SCS trial provides adequate pain relief (demonstrates a reduction in pain of at least 50% or more during the trial period), then a permanent system may be implanted. Documentation of the reduction of pain should be based on objective evidence of pain relief (e.g. decreased opioid usage, improved range of motion of the affected area, increased activity, increased pain relief according to the Visual Analog Scale (VAS) of the Numeric Pain Intensity Scale).

 

The trial electrodes are often removed, and implantation of new electrodes and the pulse generator are performed as a separate procedure.  The permanent electrodes should be placed in the same spinal region(s) where the temporary trial produced the pain relief (example, trial in lumbar region results in permanent electrode placement in the lumbar region).  The permanent electrodes should be placed in the same spinal region(s) where the temporary trial produced the pain relief (example, trial in lumbar region results in permanent electrode placement in the lumbar region). The electrode placement for implantation may be performed by laminotomy or percutaneous approach. A small incision is made to allow insertion of epidural needles, anchoring of the leads after insertion, and tunneling of the lead extension cable. The leads are placed by fluoroscopy and tested for paresthesia. After stimulation is programmed, the level of sedation can be deepened as appropriate for generator placement. A second incision is made to create the pocket for the implantable pulse generator (IPG). The generator is usually implanted in the abdomen or buttock region. The extension cable must be tunneled under the skin between the lead connector and the IPG.

 

On rare occasions, surgical revisions may be needed if the neurostimulator electrodes migrate or move from the area needing stimulation. Also, if the individual is unable to tolerate the electrodes, the individual has an onset of neurological deficits, the modality itself becomes ineffective over time, or, if the leads and/or pulse generator become infected, the device may be removed. 

Indications for Spinal Cord Stimulation (SCS)

Treatment-Refractory Chronic Pain of the Trunk or Limb

For individuals who have treatment-refractory chronic pain of the trunk or limb due to conditions such as failed back syndrome, complex regional pain syndrome (CRPS; formerly known as reflex sympathetic dystrophy), lumbosacral archnoiditis, radiculopathy, phantom limb syndrome and diabetic neuropathy who receive standard spincal cord stimulation (SCS) the evidence includes systematic reviews and randomized controlled trials (RCTs). These trials have shown a significant benefit with SCS for these patients with underlying neuropathic pain processes. Systemic reviews have supported the use of SCS to treat refractory trunk or limb pain, and patients who have failed all other treatment modalities have few options. The evidence is sufficient to determine that the technology results in a meaningful improvement in net health outcome.

 

For individuals who have treatment-refractory chronic pain of the trunk or limbs due to conditions such as failed back syndrome, complex regional pain syndrome (CRPS; formerly known as reflex sympathetic dystrophy), lumbosacral archnoiditis, radiculopathy, phantom limb syndrome and diabetic neuropathy who receive high-frequency spinal cord stimulation (SCS), the evidence includes 2 RCTs. Based on the studies high-frequency SCS as an alternative to standard SCS is proven safe and effective for the treatment of chronic treatment-refractory chronic pain of the trunk or limb. The evidence is sufficient to determine that the technology results in meaningful improvement in net health outcomes.

 

Critical Limb Ischemia

Critical limb ischemia is described as pain at rest or the presence of ischemic limb lesions. If the patients are not suitable candidates for limb revascularization (typically due to insufficient distal runoff), amputation may be required in a substantial number of patients. SCS has been investigated in this subset of patients as a technique to relieve pain and decrease incidence of amputation.

 

Based on review of the peer reviewed medical literature there were five relatively small RCTs comparing SCS versus usual care for patients with critical limb ischemia. SCS did not result in a significantly lower rate of amputation and therefore, the evidence is insufficient to determine whether SCS would improve net health outcomes for patients with critical limb ischemia and therefore, is considered investigational.       

 

Refractory Angina Pectoris

Spinal cord stimulation (SCS) has been used in the treatment of patients with refractory angina pectoris who fail to respond to standard pharmacotherapies and are not candidates for surgical interventions.  Numerous small RCTs have evaluated SCS as a treatment for refractory angina. While some studies have reported a benefit, the majority have not. In more recent RCTs, there was no significant benefit on the primary outcomes. Overall, this evidence is mixed and insufficient to allow conclusions on whether net health outcomes are improved and therefore, is considered investigational. 

 

Heart Failure

Findings of a small pilot crossover RCT evaluating SCS for heart failure were published in 2014 by Torre-Amione et al. Eligibility included symptomatic heart failure despite optimal medical therapy, left ventricular ejection fraction less than 30%, hospitalization or need for intravenous inotropic support in the past year, and ability to walk less than 450 meters on a 6-minute walk test. All patients had an implanted heart device. Nine patients underwent SCS implantation and received 3 months of active treatment and 3 months of inactive treatment (off position), in random order. There was a 1-month washout period between treatments. The primary outcome was a composite of death, hospitalization for worsening heart failure, and symptomatic bradyarrhythmia or tachyarrhythmia requiring high-voltage therapy. Four patients experienced at least 1 of the events in the composite end point. The event occurred in 2 patients while the device was turned on and 2 while it was turned off. One patient died about 2 months after implantation while the device was turned off. The SCS devices did not interfere with the functioning of implantable cardioverter defibrillators. 

 

In 2016, Zipes et. al. reported the results of the DEFEAT-HF trial, a prospective, multicenter, single-blind RCT trial comparing spinal cord stimulation (SCS) with active stimulation to sham-control in patients with New York Heart Association functional class III heart failure with a left ventricular ejection fraction of 35% or less. Sixty six patients were implanted with a SCS and randomized in a 3:2 manner to SCS on (n=42) or SCS off (sham; n=24). For the study’s primary end point (change in left ventricular end systolic volume index from baseline to 6 months), there was no significant difference between groups (p=0.30). Other end points related to heart failure hospitalization and heart failure related quality of life scores and symptoms did not differ significantly between groups. After completion of the 6 month randomization period, all subjects received active SCS. From baseline to 12 month follow-up, there were no significant treatment effects in the overall patient population from echocardiographic parameters (p=0.36). The nonsignificant difference between groups might have been the result of underpowering. However, the absence of any treatment effects or between group differences is further suggestive of lack of efficacy of SCS for heart failure. 

 

The evidence is insufficient to determine the effects of the technology and net health outcomes. Additional RCTs with larger sample sizes and longer follow-up are needed to draw conclusions on the safety and effectiveness of spinal cord stimulation (SCS) for treatment of heart failure.

Cancer Related Pain

A substantial number of patients with cancer pain do not obtain satisfactory relief with conventional first line approaches, including treatment of underlying causes, if possible, opioid based pharmacotherapy and noninvasive second line therapies. For some patients interventional pain management strategies may offer safe and effective pain relief. Interventional pain management may include injection based treatments, catheter based infusion therapies, implanted devices such as spinal cord stimulation and some surgical approaches.

 

In a 2013, a Cochrane review was published on SCS for treatment of cancer related pain in adults. The author did not identify any RCTs evaluating the efficacy of SCS in patients with cancer related pain. Four case series using a before-after design with a total of 92 patients were identified. This review was updated in 2015 (Peng et. al.), no new studies meeting inclusion criteria were identified. The authors concluded the evidence is insufficient to establish the role of SCS in treatment refractory cancer related pain. Future randomized studies should focus on the implantation of SCS in participants with cancer-related pain. There are no randomized controlled trials (RCTs) evaluating SCS for cancer related pain, in the absence of controlled studies, the evidence is insufficient to determine the effects on net health outcomes and is considered investigational.   

 

Nociceptive Pain and Central Deafferentation Pain

Based on the peer reviewed literature spinal cord stimulation is generally not effective in treating nociceptive (pain which results from irritation, not damage to the nerves), or for central deafferentation pain (related to central nervous system damage from a stroke or spinal cord injury). The use of spinal cord stimulation for these indications would be considered investigational.

 

Practice Guideline and Position Statements

National Institute of Health and Clinical Excellence (NICE)

In October 2008, The National Institute for Health and Clinical Excellence (NICE) issued a guideline on spinal cord stimulation for chronic pain of neuropathic or ischemic origin. The guideline stated that SCS is recommended as a treatment option for adults with chronic pain of neuropathic origin who continue to experience pain chronic pain (measuring at 50 mm on a 0-100 mm VAS) for at least 6 months despite appropriate conventional medical management, and who have had a successful trial of stimulation as part of an assessment by a specialist team.

 

Spinal cord stimulation is not recommended as a treatment option for adults with chronic pain of ischemic origin except in the context of research as part of a clinical trial.

 

American Society of Interventional Pain Physicians (ASIPP)

In 2013, The American Society of Interventional Pain Physicians updated their evidence based guidelines for interventional techniques in the management of chronic spinal pain. The guidelines included the statement that there is fair evidence in support of SCS in managing patients with failed back syndrome.

 

Neuropathic Pain Special Interest Group of the International Association for the Study of Pain

In 2013, the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain published recommendations on management of neuropathic pain. The interest group issued 2 recommendations on SCS; both were considered weak due to the amount and consistency of the evidence. The recommendations supported the use of SCS for failed back surgery syndrome and for complex regional pain syndrome (CRPS).

 

Regulatory Status

A large number of neurostimulator devices, some used for spinal cord stimulation (SCS), have been approved by FDA through premarket approval process. Examples of fully implantable SCS devices approved for marketing by the U.S. Food and Drug Administration (FDA) under the premarket approval (PMA) process include, but may not be limited to, Algovita, Eon, Eon Mini, Genesis, IPG System, ItreI4, Precision Plus SCS System, PrimeAdvanced Nuerostimulator, Protégé, RestoreAdvanced, RestorePrime, RestoreSensor, RestoreUltra, and Spectra WaveWriter SCS System.

 

In May 2015, FDA approved the Nevro SenzaTM Spinal Cord Stimulator (Nevro Corp. Menlo Park, CA), a totally implantable neurostimulator device, for the following indications: “chronic intractable pain of the truck and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain.” This device uses a higher frequency of electrical stimulation (10 kHz) than standard devices.

 

In February 2016, the Axium Neurostimulator System was approved by the FDA through the premarket approval process. This implanted device stimulates the dorsal root ganglion. Further, it is indicated as an aid in the management of moderate to severe intractable pain of the lower limbs in adults with complex regional pain syndrome types I and II.

 

In August 2016, the Freedom Spinal Cord Stimulator (Stimwave Technologies, Fort Lauderdale, FL), a wireless injectable stimulator, was cleared for marketing by FDA through the 510(k) process for treating chronic intractable pain of the trunk and/or lower limbs. The Freedom device has implantable or injectable microstimulators that contain electrode(s). The microstimulators with electrodes are powered by a wireless battery pack worn externally. The device can be placed to target the spinal cord (i.e. levels T7 to l) or to target the dorsal root ganglion.

 

In October 2016, the FDA approved BurstDR stimulation (St. Jude Medical, Plano, TX), a clinical programmer application that provides intermittent “burst: stimulation for patients with certain St. Jude SCS devices.

 

Prior Approval:

Not applicable

 

Policy:

Implantation of a Temporary (Trial) Spinal Cord Stimulation (SCS) Device

A trial period using a temporary standard or high frequency spinal cord stimulator device may be considered medically necessary when All of the following criteria are met:

 

An individual has undergone careful screening, including evaluation by a multi-disciplinary team that confirms the existence of one of the following conditions:

  • Failed back syndrome or post-laminectomy syndrome
  • Complex regional pain syndrome (CRPS), type I or type II (formerly known as reflex sympathetic dystrophy (RSD)) 
    • Type I CRPS is associated with symptomatic tissue injury
    • Type II CRPS is associated with nerve injury
  • Chronic neuropathic pain of certain origins (last resort treatment of moderate or severe pain (5 or more on a 10-point Visual Analog Scale (VAS) or the Numeric Pain Intensity Scale)):
    • Lumbosacral arachnoiditis (arachnoiditis is usually documented by the presence of high levels of proteins in the cerebrospinal fluid and/or by myelography or MRI); or
    • Radiculopathy; or
    • Phantom limb syndrome (stump pain); or
    • Peripheral neuropathy; or
    • Patients with chronic back pain (neuropathic pain) who are non-surgical candidates; and

Documentation in the medical record of the failure of 6 months of conservative treatment modalities (pharmacologic, surgical, psychological or physical therapies), if appropriate and not contraindicated; and

 

Further surgical intervention is not indicated; and

 

Psychological evaluation has been obtained and there is documentation stating the pain is not psychologic in origin; and

 

There is no evidence of existing untreated drug addiction; and

 

No contraindications to implantation exist (i.e. sepsis or coagulopathy issues).

 

Implantation of Permanent Spinal Cord Stimulation (SCS) Device

Placement of a permanent standard or high frequency spinal cord stimulator device may be considered medically necessary when the above medical necessity criteria for a trial (temporary) placement of spinal cord stimulation are met, and All of the following are met:

  • Pain relief of at least 50% or more since the start of the trial period of the temporary SCS device as documented in the medical record; and
  • There is objective evidence per documentation in the medical records of pain relief (e.g., decreased opioid usage, improved range of motion of the affected area, increased activity, increased pain relief according to the Visual Analog Scale [VAS] or the Numeric Pain Intensity Scale).

 

Replacement of Spinal Cord Stimulator Device

Replacement of standard or high-frequency spinal cord stimulator and/or battery/generator may be considered medically necessary for an individual that meets the above medical necessity criteria and the existing stimulator and/or battery/generator are/is no longer under warranty and cannot be repaired.

 

Replacement of a functioning standard spinal cord stimulator (SCS) device with a high-frequency spinal cord stimulator (SCS) device is considered not medically necessary.

 

Removal or Revision of Spinal Cord Stimulator Device

The removal or revision of a standard or high-frequency spinal cord stimulator device may be considered medically necessary for any of the following indications:

  • Migration of lead(s)
  • Loss of effectiveness
  • Intolerance by individua
  • lnfection
  • Painful generator site
  • Development of neurological deficits
  • Need for MRI study

Spinal cord stimulation is considered investigational for all other indications including but not limited to the following because the safety and effectiveness cannot be established based on review of the available published peer reviewed medical literature.  Additional randomized controlled trials (RCTs) with larger sample sizes and follow-up are needed to draw conclusions on the safety and effectiveness. The evidence is insufficient to determine the effects on net health outcomes:

  • Treatment of cancer related pain
  • Treatment of peripheral vascular disease
  • Treatment of chronic pain of ischemic origin:
    • Treatment of critical limb ischemia as a technique to forestall amputation
    • Treatment of refractory angina pectoris
  • Treatment of Multiple Sclerosis & spasticity disorders
  • Treatment of axial and other musculoskeletal pain syndromes
  • Treatment of scoliosis
  • Treatment of nociceptive pain (resulting from irritation, not damage to nerves)
  • Treatment of central deafferentation pain (related to central nervous  system damage from a stroke or spinal cord injury)
  • Treatment of post-herpatic neuralgia
  • Treatment of heart failure
  • Treatment of fibromyalgia

 

Definitions

Arachnoiditis

Painful condition caused by inflammation of the arachnoid, one of the three linings that surround and protect the brain and the spinal cord. The arachnoid can become inflamed due to a variety of reasons. These include irritation from chemicals present myelograms and epidural steroid injections; bacterial or viral infections; spinal cord injury; or complications from spinal surgery or other invasive spinal procedures. When arachnoiditis begins to impact the nerves, it can cause a number of symptoms, including numbness, tingling, and a distinctive stinging and burning pain the lower back and legs. Other symptoms may include debilitating muscle cramps, twitches, spasms and bladder/bowel/sexual dysfunction. There is no cure for this condition, so the goal of treatment is to control pain and symptoms.

 

Arachnoiditis is usually documented by the presence of high levels of proteins in the cerebrospinal fluid and/or by myelography or magnetic resonance imaging (MRI).

 

Complex Regional Pain Syndrome (CRPS)

Is an uncommon nerve disorder which causes intense burning pain, usually in the arms, hands, legs or feet. It can occur after an injury, either to a nerve or to tissue in the affected area. Along with pain, the patient may experience extreme skin sensitivity and changes in color, temperature or moistness of the skin. The cause of CRPS is unknown, and there is no cure.

 

Failed Back Syndrome (FBSS) or post laminectomy syndrome (lumbar or cervical)

Is persistent or recurrent pain, mainly involving the lower back and/or legs, even after prior anatomically successful spinal surgery. FBSS is considered a diagnosis of exclusion, so CT scans or MRIs must demonstrate that there are no surgically correctable lesions present. Patients with FBSS often have epidural/intraneural/perineural fibrosis or scar tissue, which generally will not respond to surgery but may respond to spinal cord stimulator (SCS).

    

Neuropathic Pain

Otherwise known as “nerve pain” is a complex, chronic pain state that usually is accompanied by tissue injury. With neuropathic pain, the nerve fibers themselves might be damaged, dysfunctional or injured. These damaged nerve fibers send incorrect signals to other pain centers. The impact of nerve fiber injury includes a change in nerve function both at the site of injury and areas around the injury.

 

Nociceptive Pain

Nociceptors are the nerves which sense and respond to parts of the body which suffer from damage. They signal tissue irritation, impending injury or actual injury. When activated they transmit pain signals (via the peripheral nerves as wella s the spinal cord) to the brain. The pain is typically well localized, constant and often with an aching throbbing quality. Visceral pain is the subtype of nociceptive pain that involves the internal organs. It tends to be episodic and poorly localized.

 

Nociceptive pain is usually time limited, meaning when the tissue damage heals, the pain typically resolves.

 

Central Deafferentation Pain

Central pain is defined as pain that is initiated by a primary lesion within the CNS. Central pain can occur in association with all types of CNS lesions related to wide variety of pathological processes. Deafferentation pain denotes a type of pain that results from complete or partial interruption of afferent nerve impulses. This type of pain results from lesions that interrupt the spinothalmic pathways at any level of the nervous system.

 

Patients with deafferentation pain usually display varying degrees of sensory loss characterized by disturbances with pain and temperature sensation.

     

Critical Limb Ischemia (CLI):

Is a severe blockage in the arteries of the lower extremities, which markedly reduces blood-flow. It is a serious form of peripheral arterial disease, or PAD. CLI is a chronic condition that results in severe pain in the feet or toes, even while resting. Complications of poor circulation can include sores and wounds that won't heal in the legs and feet. Left untreated, the complications of CLI will result in amputation of the affected limb.

 

Refractory Angina Pectoris:

Is a chronic condition characterized by the presence of angina caused by coronary insufficiency in the presence of coronary artery disease which cannot be controlled by a combination of medical therapy, angioplasty and coronary bypass surgery. The presence of reversible myocardial ischemia should be clinically established to be the cause of the symptoms. Chronic is defined as a duration of more than 3 months.

 

Ischemic Pain

Is caused by a reduction in oxygen delivery to the tissue, usually caused by reductive in blood flow because of construction of blood vessel (vasospasm) or its obstruction by atheroma or embolus. Ischemic pain conditions include critical limb ischemia & refractory angina).  

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 63650 Percutaneous implantation of neurostimulator electrode array, epidural
  • 63655 Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural
  • 63661 Removal of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed
  • 63662 Removal of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed
  • 63663 Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed
  • 63664 Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed
  • 63685 Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling
  • 63688 Revision or removal of implanted spinal neurostimulator pulse generator or receiver
  • C1767 Generator neurostimulator (implantable) non-rechargeable
  • C1778 Lead, neurostimulator
  • C1787 Patient programmer, neurostimulator
  • C1816 Receiver and/or transmitter neurostimulator (implantable)
  • C1820 Generator, neurostimulator (implantable), non high-frequency with rechargeable battery and charging system
  • C1822 Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging system
  • C1897 Lead neurostimulator test kit (implantable)
  • L8679 Implantable neurostimulator, pulse generator any type
  • L8680 Implantable neurostimulator electrode, each
  • L8681 Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only
  • L8682 Implantable neurostimulator radiofrequency receiver
  • L8683 Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver
  • L8685 Implantable neurostimulator pulse generator, single array, rechargeable includes extension
  • L8686 Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
  • L8687 Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
  • L8688 Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension
  • L8689 External recharging system for battery (internal)for use with implantable neurostimulator, replacement only
  • 95970 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple or complex brain, spinal cord, or peripheral (ie, cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming
  • 95971 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming
  • 95972 Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming

 

Selected References:

  • ECRI. Rechargeable Spinal Cord Stimulation Systems for Chronic Pain Control. Plymouth Meeting (PA): ECRI Health Technology Information Service 2008 March 20. 11 p. (ECRI Hotline Response).
  • UpToDate. Complex Regional Pain Syndrome in Adults; Prevention and Management. Salahadin Abdi, M.D., PhD. Topic Last Updated August 17, 2016.
  • UpToDate. New Therapies for Angina Pectoris. Michael Simons, M.D., Roger J. Laham, M.D.. Topic Last Updated September 23, 2013.
  • UpToDate. Treatment of Chronic Lower Extremity Critical Limb Ischemia. David G. Neschis, M.D., Michael A. Golden,M.D.. Topic Last Updated October 25, 2012.
  • National Institute of Health, National Institute of Neurological Disorders and Stroke Arachnoiditis Information Page.
  • ECRI. Rechargeable Spinal Cord Systems for Managing Chronic Pain. ECRI Hotline Response. February 2013.
  • National Institute of Health and Clinical Excellence (NICE). Spinal Cord Stimulation for Chronic Pain of Neuropathic or ischemic Origin. Issue date: October 2008. Review date: November 2011
  • Agency for Healthcare Research and Quality (AHRQ). Practice Guideline for Chronic Pain Management. American Society of Anesthesiologists (ASA) and American Society of Regional Anesthesia and Pain Medicine.
  • American Association of Neurological Surgeons (AANS). Patient Information. Spinal Cord Stimulation. October 2008.
  • American Society of Interventional Pain Physicians (ASIPP) and Interventional Pain Management (IPM). Comprehensive Evidence Based Guidelines for Interventional Techniques in the Management of Chronic Spinal Pain. Pain Physician 2009; 12:699-802.
  • National Guideline Clearinghouse: 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease. J AM Coll Cardiol. 2012 Dec 18; 60(24):e44-e164.
  • American Chronic Pain Association Chronic Pain Medication & Treatment 2014 Edition.
  • Centers for Medicare and Medicaid Services National Coverage Determination for Electrical Stimulators (160.7). 
  • Medtronic
  • American Pain Society (APS). APS Clinical Guideline for Evaluation and Management of Low Back Pain.
  • American Association of Neurological Surgeons (AANS). Patient Information, Spinal Cord Stimulation. October 2008.
  • Institute for Clinical Systems Improvement (ICSI), Assessment and Management of Chronic Pain. Updated November 2013.
  • North American Neuromodulation Society Neuromodulation Therapy Access Coalition Position Statement on Spinal Cord Neurostimulation.
  • North American Neuromodulation Society Painful Peripheral Neuropathy.
  • ECRI. Hotline Response Spinal Cord Stimulation for Treatment Peripheral Neuropathy, March 2014.
  • Medscape Spinal Cord Stimulation: Indications and Outcomes.
  • Medscape Spinal Cord Stimulation. Updated June 26, 2012.
  • Medscape Spinal Cord Stimulation “Last Resort” for Diabetic Nerve Pain, Miriam E. Tucker, September 30, 2014.
  • PubMed, De Vries J, et. al. Spinal Cord Stimulation for Ischemic Heart Disease and Peripheral Vascular Disease. Adv Tech Stand Neurosurg 2007;32:63-89.
  • PubMed, Vallejo R, et. al. Neuromodulation of the Cervical Spine Cord in the Treatment of Chronic Intractable Neck and Upper Extremity Pain: A Case Series and Review of the Literature. Pain Physician 2007 Mar;10(2):305-11.
  • PubMed, Dausi C, et. al. Electrical Spinal Cord Stimulation in the Long Term Treatment of Chronic Painful Diabetic Neuropathy. Diabet Med 2005 Apr;22(4):393-8.
  • PubMed, de Vos CC, et. al. Spinal Cord Stimulation in Patients with Painful Diabetic Neuropathy: A Multicenter Randomized Clinical Trial. Pain 2014 Aug 29.
  • Pain Medicine News, Neuropathic Pain of Postherpatic Neuralgia.
  • Cochrane Data Base of Systemic Reviews Publisher John Wiley & Sons, Ltd. Publication February 28, 2013, Spinal Cord Stimulation for Cancer Related Pain in Adults.
  • UpToDate. Investigational Therapies for Treating Symptoms of Lower Extremity Peripheral Artery Disease, Emile R. Mohler III, M.D., Topic last updated May 19, 2017.
  • UpToDate.  Subacute and Chronic Low Back Pain: Surgical Treatment, Roger Chou, M.D., Topic last updated March 11, 2016.
  • UpToDate. Prevention and Management of Complex Regional Pain Syndrome in Adults, Salahadin Abdi, M.D., PhD., Topic last updated April 25, 2016.
  • UpToDate. Overview of the Treatment of Chronic Non-Cancer Pain, Ellen WK Rosenquist, M.D., Topic last updated August 17, 2017.
  • UpToDate. Treatment of Cervical Radiculopathy, Jenice Robinson, M.D., Milind J. Kothari, M.D.. Topic last updated May 7, 2015.  
  • UpToDate. Brachial Plexus Syndrome, Mark B. Bromberg, M.D., PhD. Topic last updated April 20, 2015.
  • UpToDate. Cancer Pain Management: Interventional Therapies, Ronald Kaplan M.D., Russell K. Portenoy, M.D., Topic last updated May 8, 2017.
  • UpToDate. Adolescent Idiopathic Scoliosis: Treatment of Prognosis, Susan A. Scherl, M.D., Topic last updated July 15, 2015.
  • UpToDate. Postherpatic Neuralgia, Zahid H. Bajwa, M.D. Topic last updated April 27, 2015,
  • International Modulation Society (INS), Spinal Cord Stimulation for Neuropathic Pain.
  • UpToDate. Treatment of Chronic Lower Extremity Critical Limb Ischemia, David G. Neschis M.D., Michael A Golden, M.D., Topic last updated July 17, 2015.
  • UpToDate. Treatment of Fibromyalgia in Adults not Responsive to Initial Therapies, Don L. Goldenberg, M.D., Topic last updated August 28, 2015.
  • Torre-Amione G, Alo K, Estep JD, et. al. Spinal Cord Stimulation is Safe and Feasible in Patients with Advanced Heart Failure: Early Clinical Experience, Eur J Heart Fail. July 2014;16(7):788795
  • International Neuromodulation Society Spinal Cord Stimulation’s Role in Managing Chronic Disease Symptoms. 2013.
  • Dworkin RH, O'Connor AB, Kent J, et al. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain. Nov 2013;154(11):2249-2261. PMID 23748119
  • Food and Drug Administration Summary of Safety and Effectiveness Data (SSED): Senza Spinal Cord Stimulation (SCS) System 2015. Accessed April, 2016.
  • Nevro Corp Senza System
  • UpToDate. Spinal Cord Stimulation: Placement and Management. Anne Marie McKenzie-Brown M.D., Topic last updated November 1, 2016.
  • Grider JS, Manchikanti L, Carayannopoulos A, et al. Effectiveness of spinal cord stimulation in chronic spinal pain: a systematic review. Pain Physician. Jan 2016;19(1):E33-54. PMID 26752493
  • Kapural L, Yu C, Doust MW, et al. Novel 10-kHz High-frequency Therapy (HF10 Therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: the SENZA-RCT randomized controlled trial. Anesthesiology. Oct 2015;123(4):851-860. PMID 26218762
  • Slangen R, Schaper NC, Faber CG, et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial. Diabetes Care. Nov 2014;37(11):3016-3024. PMID 25216508 
  • van Beek M, Slangen R, Schaper NC, et al. Sustained treatment effect of spinal cord stimulation in painful diabetic peripheral neuropathy: 24-month follow-up of a prospective two-center randomized controlled trial. Diabetes Care. Sep 2015;38(9):e132-134. PMID 26116722
  • Duarte RV, Andronis L, Lenders MW, et al. Quality of life increases in patients with painful diabetic neuropathy following treatment with spinal cord stimulation. Qual Life Res. Dec 22 2015. PMID 26694963
  • Tiede J, Brown L, Gekht G, et al. Novel spinal cord stimulation parameters in patients with predominant back pain. Neuromodulation. Jul-Aug 2013;16(4):370-375. PMID 23433237
  • Van Buyten JP, Al-Kaisy A, Smet I, et al. High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Neuromodulation. Jan-Feb 2013;16(1):59-65; discussion 65-56. PMID 23199157
  • Perruchoud C, Eldabe S, Batterham AM, et al. Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study. Neuromodulation. Jul-Aug 2013;16(4):363-369; discussion 369. PMID 23425338
  • Abu Dabrh AM, Steffen MW, Asi N, et al. Nonrevascularization-based treatments in patients with severe or critical limb ischemia. J Vasc Surg. Nov 2015;62(5):1330-1339 e1313. PMID 26409842
  • Tsigaridas N, Naka K, Tsapogas P, et al. Spinal cord stimulation in refractory angina. A systematic review of randomized controlled trials. Acta Cardiol. Apr 2015;70(2):233-243. PMID 26148385
  • Eldabe S, Thomson S, Duarte R, et al. The effectiveness and cost-effectiveness of spinal cord stimulation for refractory angina (RASCAL Study): a pilot randomized controlled trial. Neuromodulation. Jan 2016;19(1):60-70. PMID 26387883
  • Zipes DP, Neuzil P, Theres H, et al. Determining the feasibility of spinal cord neuromodulation for the treatment of chronic systolic heart failure: The DEFEAT-HF Study. JACC Heart Fail. Feb 2016;4(2):129-136. PMID 26682789
  • Peng L, Min S, Zejun Z, et al. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev. 2015;6:CD009389. PMID 26121600
  • UpToDate. Treatment of Diabetic Neuropathy. Eva L. Feldman M.D., PhD, David K. McCulloch M.D., Topic last updated April 6, 2017.
  • UpToDate. Lower Extremity Peripheral Artery Disease in End Stage Renal Disease. Ann M. O’Hare M.D., Kristen Johansen, M.D., Topic last updated March 9, 2016. 
  • ECRI. Technology News. Novel High Frequency Spinal Cord Stimulation Reportedly Avoids Paresthesia and Relives Chronic Back and Leg Pain. Published 8/14/2015.
  • de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: a multicenter randomized clinical trial. Pain. Nov 2014;155(11):2426-2431. PMID 25180016
  • Bicket MC, Dunn RY, Ahmed SU. High-frequency spinal cord stimulation for chronic pain: pre-clinical overview and systematic review of controlled trials. Pain Med. Dec 2016;17(12):2326-2336. PMID 28025366
  • Kapural L, Yu C, Doust MW, et al. Comparison of 10-kHz high-frequency and traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: 24-month results from a multicenter, randomized, controlled pivotal trial. Neurosurgery. Nov 2016;79(5):667-677. PMID 27584814
  • Hou S, Kemp K, Grabois M. A systematic evaluation of burst spinal cord stimulation for chronic back and limb pain. Neuromodulation. Jun 2016;19(4):398-405. PMID 27139915
  • De Ridder D, Plazier M, Kamerling N, et al. Burst spinal cord stimulation for limb and back pain. World Neurosurg. Nov 2013;80(5):642-649.e641. PMID 23321375
  • Schu S, Slotty PJ, Bara G, et al. A prospective, randomised, double-blind, placebo-controlled study to examine the effectiveness of burst spinal cord stimulation patterns for the treatment of failed back surgery syndrome. Neuromodulation. Jul 2014;17(5):443-450. PMID 24945621
  • Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. Apr 2017;158(4):669-681. PMID 2803047
  •  Liem L, Russo M, Huygen FJ, et al. One-year outcomes of spinal cord stimulation of the dorsal root ganglion in the treatment of chronic neuropathic pain. Neuromodulation. Jan 2015;18(1):41-48; discussion 48-49. PMID 25145467
  • Schu S, Gulve A, ElDabe S, et al. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Pain Pract. Apr 2015;15(4):293-299. PMID 2469021226.
  • Weiner RL, Yeung A, Montes Garcia C, et al. Treatment of FBSS low back pain with a novel percutaneous DRG wireless stimulator: pilot and feasibility study. Pain Med. Oct 2016;17(10):1911-1916. PMID 27125284
  • Ubbink DT, Vermeulen H. Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia. Cochrane Database Syst Rev. 2013;2:CD004001. PMID 23450547
  • Pan X, Bao H, Si Y, et al. Spinal cord stimulation for refractory angina pectoris: a systematic review and metaanalysis. Clin J Pain. Nov 21 2016. PMID 27875377
  • Tsigaridas N, Naka K, Tsapogas P, et al. Spinal cord stimulation in refractory angina. A systematic review of randomized controlled trials. Acta Cardiol. Apr 2015;70(2):233-243. PMID 26148385
  • Lihua P, Su M, Zejun Z, et al. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev. 2013;2:CD009389. PMID 23450600
  • Peng L, Min S, Zejun Z, et al. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev. 2015;6:CD009389. PMID 26121600
  • Cruccu G, Garcia-Larrea L, Hansson P, et al. EAN guidelines on central neurostimulation therapy in chronic pain conditions. Eur J Neurol. Oct 2016;23(10):1489-1499. PMID 27511815
  • ECRI. Senza Spinal Cord Stimulation System (Nevro Corp) for Treating Chronic Pain. Published 11/6/2014 and Updated 9/15/2015.
  • ECRI. Overview of Selceted Spinal Cord Stimulators. Clinical Comparison July 2015.
  • ECRI. Algovita Spinal Cord Stimulation System. FDA Approvals and Clearances News. Published 12/1/2015.
  • ECRI. Precision Spectra and Precision Plus Spinal Cord Systems (Boston Scientific Corp) for Managing Chronic Pain. Published 7/21/2016.
  • ECRI. Protégé SCS (St. Jude Medical) for Treating Chronic Pain.
  • Axium Neurostimulation System U.S. Food and Drug Administration (FDA) Medical Devices.
  • Axium Neurostimulation System St. Jude Medical.
  • Freedom Stimulators

 

Policy History:

  • August 2017 - Annual Review, Policy Revised
  • August 2016 - Annual Review, Policy Renewed
  • September 2015 - Annual Review, Policy Revised
  • February 2015 - Policy Revised
  • October 2014 - Annual Review, Policy Revised
  • May 2014 - Interim Review, Policy Revised
  • January 2014 - Interim Review, Revision and new policy created
  • January 2013 - Annual Review, Policy Renewed
  • January 2012 - Annual Review, Policy Renewed
  • February 2011 - Interim Review, Policy Revised
  • October 2010 - Annual Review, Policy Renewed

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.