Medical Policy: 07.01.61
Original Effective Date: November 2000
Reviewed: August 2017
Revised: August 2017
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.
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.
Patients being considered for spinal cord stimulation should ideally meet the following criteria:
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:
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:
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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).
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.
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:
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).
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:
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.
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:
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:
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).
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.
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).
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.
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 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.
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.
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.
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).
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