Latest Review Date: May 2024

Category:  Surgery                                                                

POLICY:

Spinal cord and dorsal root ganglion stimulation, including high-frequency and burst spinal cord stimulators, may be considered medically necessary for the treatment of the following indications:

• Severe and chronic pain of the trunk or limbs
• Complex regional pain syndrome (CRPS) (also known as reflex sympathetic dystrophy (RSD);

• Failed back surgery syndrome
• Diabetic Neuropathy and peripheral neuropathy

• *Moderate to severe chronic neuropathic pain:
  • Lumbosacral arachnoiditis
  • Phantom limb/stump pain
  • Post-herpetic neuralgia
  • Intercostal neuralgia
  • Cauda equina injury
  • Incomplete spinal cord injury
  • Plexopathy

AND when all of the following criteria, are clearly documented in the individual’s record:

• The implantation of the stimulator is used only as a late or last resort for individuals with chronic pain (present for ≥ three months); and
• Refractory to all other treatment modalities (pharmacological, surgical, physical or psychological therapies) have been tried and did not prove satisfactory or are judged unsuitable or contraindicated for the given individual; and
• All of the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment, training, and follow-up of the individual must be available; and
• Demonstration of at least 50% pain relief with a temporarily implanted electrode precedes permanent implantation; (revision or replacement of the pulse generator, electrodes or receiver does not require a trial).
• No serious untreated drug habituation exists.

*Moderate to severe pain as 5 or more on a 10-point VAS scale.

**Standard therapy: non-steroidal anti-inflammatory drugs, tricyclic antidepressants, and anticonvulsants.

Spinal cord and dorsal root ganglion stimulation is considered investigational for the following indications, including but not limited to:

• Refractory angina pectoris
• Treatment of critical limb ischemia to forestall amputation
• Treatment of heart failure
• Cancer-related pain

Replacement or upgrade of existing, properly functioning equipment, even if warranty has expired, is considered not medically necessary.

NOTE: "Burst" neurostimulation is an alternate programming of a standard SCS device. A clinician programmer application is used to configure a standard SCS device to provide stimulation in "bursts" rather than at a constant ("tonic") rate.

DESCRIPTION OF PROCEDURE OR SERVICE:

Spinal cord stimulation (SCS) delivers low voltage electrical stimulation to the dorsal columns of the spinal cord to block the sensation of pain. Spinal cord stimulation devices have a radiofrequency receiver that is surgically implanted and a power source (battery) that is either implanted or worn externally. Other neurostimulators target the dorsal root ganglion (DRG).

Chronic Pain

Spinal cord stimulation (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

Spinal cord stimulation (also called dorsal column stimulation) involves the use of low-level epidural electrical stimulation of the spinal cord dorsal columns. The neurophysiology of pain relief after spinal cord stimulation is uncertain, but may be related to either activation of an inhibitory system or blockage of facilitative circuits.

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 electricity. The lead may incorporate from 4 to 8 electrodes, with 8 electrodes more commonly used for complex pain patterns. There are 2 basic types of power source: 1 type, the power source (battery), can be surgically implanted or worn externally with an antenna over the receiver; the other, a radiofrequency receiver, is implanted. Totally implantable systems are most commonly used.

The individaul's pain distribution pattern dictates at what level of 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. Implantation of the spinal cord stimulator is typically a 2-step process. Initially, the electrode is temporarily implanted in the epidural space, allowing a trial period of stimulation. Once treatment effectiveness is confirmed (defined as at least 50% reduction in pain), the electrodes and radio-receiver/transducer are permanently implanted. Successful spinal cord stimulation may require extensive programming of the neurostimulators to identify the optimal electrode combinations and stimulation channels.

Traditional spinal cord stimulation devices use electrical stimulation with a frequency of 100 to 1000 Hz. High frequency devices use electrical stimulation with a frequency of 10,000 Hz. In 2016, the U.S. Food and Drug Administration (FDA) approved a clinician programmer application that allows a spinal cord stimulation device to provide stimulation in bursts rather than at a constant rate. Burst stimulation is proposed to relieve pain with fewer paresthesias. The burst stimulation device works in conjunction with standard spinal cord stimulation devices. With the newly approved app, stimulation is provided in five, 500-Hz burst spikes at a rate of 40 Hz, with a pulse width of 1 ms. Other neurostimulators target the dorsal root ganglion.

Dorsal Root Ganglion Stimulation

Other neurostimulators target the dorsal root ganglion (DRG). Dorsal root ganglia consists of sensory cell bodies that pass on information from the peripheral nervous system to the central nervous system, and are believed to play an important 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. Two systems targeting the dorsal root ganglion have received approval or clearance from FDA.

A retrospective analysis of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database provided information on complications related to the use of DRG stimulation. The MAUDE database was queried for DRG stimulation reports through 2017, identifying 979 episodes. Complications were predominantly device-related (47%; lead migration and lead damage), with the remaining comprised of procedural complications (28%; infection, new neurologic symptoms, and dural puncture), patient complaints (12%; site pain and unwanted stimulation), serious adverse events (2.4%), and "other" complications (4.6%). The prevalence of complications cannot be estimated using the MAUDE database; while facilities are mandated to report events, individuals and health care providers may report events, but are not mandated to do so.

Outcome Measures

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) group has provided recommendations for four core chronic pain outcome domains that should be included when selecting outcome measures for clinical trials of treatments for chronic pain: (1) pain intensity; (2) physical functioning; (3) emotional functioning; and (4) participant ratings of overall improvement. IMMPACT has also suggested specific outcome measures to address these core domains and has proposed provisional benchmarks for identifying clinically important changes in these specific outcome measures (see Table 1).

Table 1. Health Outcome Measures Relevant to Trials of Chronic Pain

Domain	Outcome Measure	Description	Clinically Meaningful Difference
Pain intensity
	Numeric rating scale Verbal rating scale Visual analog scale	Rating of pain intensity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) or from 0 to 10 cm	Minimally important: 10%-20% decrease Moderately important: ≥30% decrease Substantial: ≥50% decrease
Physical functioning
	Disease specific	Measures of the interference of pain with physical functioning
	Multidimensional Pain Inventory Interference Scale	60 items, self-report 12 subscales: interference, support, pain severity, self-control, negative mood, punishing responses, solicitous responses, distracting responses, household chores, outdoor work, activities away from home, and social activities Items rated on 0- to 6-point scale Interference subscale score calculated by mean of subscale items	≥0.6-point decrease
	Brief Pain Inventory Interference Scale	7 items, self-report Measures intensity, quality, relief and interference of pain and patients’ ideas of the causes of pain Mean of the 7 interference items can be used as a measure of pain interference	1-point decrease
	Oswestry Disability Index	Measures functional impairment due to lower back pain: 10 sections, self-report Sections: intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel Each section is scored on a 0 to 5 scale with 5 indicating the greatest disability Total score calculated by taking the mean of the section scores and multiplying by 100	10 points
	General	Generic measure of physical functioning
	36-Item Short Form Health Survey	Measure overall health status: 36 items, self-report 8 domains: physical function, physical role, general health, bodily pain, mental health, social function, vitality/fatigue, and emotional role Physical Component Summary and Mental Component Summary scores are aggregate scores that can be calculated Higher scores indicate better health status	5-10 point
Emotional functioning
	Beck Depression Inventory	21 items, self-report Measures severity of current symptoms of depressive disorders Scores range from 0 to 63	≥5-point decrease
	Profile of Mood States	65 items, self-report Measures total mood disturbance with 6 subscales: tension, depression, anger, vigor, fatigue, and confusion Scores range from 0 to 200	≥10- to 15-point decrease
Global rating of improvement
	Patient Global Impression of Change	Single-item, self-rating 7-point scale ranging from 1 (very much worse) to 7 (very much improved)	Minimally important: minimally improved Moderately important: much improved Substantial: very much improve

Adverse events can either be hardware-related or biological. Hardware-related complications include lead migration, failure or fracture. Biological complications include infection and pain. More severe biological complications are rare, including dural puncture headache and neurological damage.

KEY POINTS:

The most recent literature search was through February 27, 2024.

Summary of Evidence

Treatment-Refractory Chronic Pain

For individuals who have treatment-refractory chronic pain of the trunk or limbs who receive standard spinal cord stimulation, the evidence includes systematic reviews and randomized controlled trials. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Available RCTs are heterogeneous regarding underlying diagnoses in select individual populations. However, the trials including individuals with underlying neuropathic pain processes have shown a significant benefit with spinal cord stimulation. Systematic reviews have supported the use of spinal cord stimulation to treat refractory trunk or limb pain, and individuals who have failed all other treatment modalities have few options. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have treatment-refractory chronic pain of the trunk or limbs who receive high-frequency spinal cord stimulation, the evidence includes a systematic review and  RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Two RCTs that enrolled participants not previously treated with spinal cord stimulation reported clinically and statistically significant benefits associated with high-frequency spinal cord stimulation. Another RCT in individuals who had chronic pain despite previous treatment with standard spinal cord stimulation found no benefit for those receiving high-frequency stimulation compared with sham-control; however, it is difficult to compare these findings with other trials of spinal cord stimulation due to the different patient populations, short treatment periods, and the crossover period effect. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have treatment-refractory chronic pain of the trunk or limbs who receive dorsal root ganglion neurostimulation, the evidence includes a systematic review, an RCT, and case series. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. The unblinded RCT found that individuals receiving dorsal root ganglion neurostimulation had significantly higher rates of treatment success (physical functioning score and quality of life measures), at 3 and 12 months compared with those receiving standard spinal cord stimulation devices. Dorsal root ganglion neurostimulation was found to be noninferior to spinal cord stimulation in the percentage achieving >50% pain reduction, emotional functioning score, and 36-Item Short-Form Health Survey scores. Both groups experienced paresthesias but patients in the dorsal root ganglion group reported less postural variation in paresthesia and reduced extraneous stimulation in nonpainful areas. Rates of serious adverse events were similar between the two study arms. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Critical Limb Ischemia

For individuals who have critical limb For individuals who have critical limb ischemia who receive spinal cord stimulation, the evidence includes systematic reviews of several small RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. In pooled analyses, spinal cord stimulation was associated with a lower risk of amputation versus control, but results were not consistently statistically significant due to differences in methodologies. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Treatment-Refractory Angina Pectoris

For individuals who have treatment-refractory angina pectoris who receive spinal cord stimulation, the evidence includes systematic reviews and RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. Numerous small RCTs have evaluated spinal cord stimulation as a treatment for refractory angina. While some have reported benefits, most have not. In two recent RCTs, there was no significant benefit in the primary outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Heart Failure

For individuals who have heart failure who receive spinal cord stimulation, the evidence includes RCTs. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. An RCT (N=66) comparing spinal cord stimulation using active stimulation with sham-control in individuals who had New York Heart Association functional class III heart failure and a left ventricular ejection fraction of 35% or less did not find significant differences between groups, but might have been underpowered to do so. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Cancer-Related Pain

For individuals who have cancer-related pain who receive spinal cord stimulation, the evidence includes case series. Relevant outcomes are symptoms, functional outcomes, medication use, and treatment-related morbidity. No RCTs evaluating spinal cord stimulation in this population were identified. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Association of Clinical Endocrinology

In 2022, the American Association of Clinical Endocrinology published evidence-based recommendations for the care of individuals with diabetes mellitus. The guidelines state that 'Neuromodulatory techniques such as high-frequency spinal cord stimulation and combining pharmacological with nonpharmacological approaches should be considered in those with refractory painful DPN [diabetic peripheral neuropathy]'. The evidence for the statement was rated as Grade B [Strong]; BEL [best evidence level] 1 [Randomized controlled trial; Meta-analysis of only randomized controlled trials].

American Society of Interventional Pain Physicians

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 a statement that there is fair evidence for the following recommendation for SCS: "SCS is indicated in chronic low back pain with lower extremity pain secondary to failed back surgery syndrome (FBSS), after exhausting multiple conservative and interventional modalities".

American Society of Pain and Neuroscience

The American Society of Pain and Neuroscience issued a comprehensive guideline in 2021 on the management of cancer-related pain. The guideline found that spinal cord stimulation may be considered for 1) treatment of refractory cancer pain (level II-3-C evidence: multiple series compared over time, with or without intervention, and surprising results in noncontrolled experience; treatment is neither recommendable nor inadvisable), and 2) on a case-by-case basis for "pain that is related to cancer treatment such as chemotherapy-induced peripheral neuropathy" (level III-C evidence: clinical experiences-based opinions, descriptive studies, clinical observations, or reports of expert committee; treatment is neither recommendable nor inadvisable).

The American Society of Pain and Neuroscience published consensus guidelines on interventional therapies for knee pain in 2022. The guidelines state that "Chronic pain that is refractory to acute treatment is managed by progressing to spinal cord stimulator, dorsal root ganglion stimulator, or botulinum toxin (Botox) injection." They also include the statement that "DRG [Dorsal Root Ganglion Stimulation] is a safe and effective treatment option for chronic post-surgical and focal neuropathic pain of the knee (i.e., complex regional pain syndrome [CRPS]); Level I, Grade A, Consensus Strong."

The American Society of Pain and Neuroscience published consensus guidelines on interventional therapies for back pain in 2022. The guidelines make the following recommendations for spinal cord stimulation:

Table 2. American Society of Pain and Neuroscience Recommendations for Spinal Cord Stimulation for Back Pain.

Recommendation	Grade	Level of evidence	Level of certainty of net benefit
Following lumbar surgery	A	I-A	Strong
Treatment of non-surgical low back pain	B	I-C	Moderate
Treatment of lumbar spinal stenosis	C	I-C	Moderate

International Association for the Study of Pain

In 2013, the International Association for the Study of Pain published recommendations on management of neuropathic pain. The Association issued recommendations on spinal cord stimulation, considered weak due to the amount and consistency of the evidence. The recommendations supported the use of spinal cord stimulation for failed back surgery syndrome and CRPS (Table 3). In regards to high frequency stimulation and dorsal root ganglion stimulation, the publication states that long-term effectiveness of these techniques needs to be determined with further studies.

Table 3. International Association for the Study of Pain Recommendations for SCS

Indication	Comments	Quality of Evidence	Strength of Recommendation
CRPS 1	Long-term benefits demonstrated, though benefits may diminish over time (in RCT, reoperation rate was 42%). May be considered for patients not responding to non-invasive treatments and sympathetic nerve blocks or for whom nerve blocks would be inappropriate.	Moderate	Weak
CRPS 2	Limited evidence	Low	Inconclusive
FBSS with radiculopathy	Based on 2 RCTs, appears to be better than reoperation and conventional medical management, However, response rates were relatively low and complication rates were relatively high.	Moderate	Weak

CRPS: complex regional pain syndrome; FBSS: failed back surgery syndrome; SCS: spinal cord stimulation; RCT: randomized controlled trial.

International Neuromodulation Society

The International Neuromodulation Society (2019) convened a Neuromodulation Appropriateness Consensus Committee (NACC) to develop best practices for the use of dorsal root ganglion (DRG) stimulation for the treatment of chronic pain syndromes. The NACC was comprised of experts in anesthesiology, neurosurgery, and pain medicine. The NACC performed a systematic literature search through June 2017 and identified 29 publications providing evidence for the consensus recommendations. The evidence was graded using the modified Pain Physician criteria and the U.S. Preventive Services Task Force criteria. Table 4  summarizes the consensus recommendations on the use of DRG stimulation. Additional recommendations on the use of DRG stimulation procedure are provided in the publication.

Table 4. NACC Consensus Recommendations for the Use of DRG Stimulation

Recommendation	Level	Grade	Consensus
DRG stimulation should be considered primarily for patients with focal neuropathic pain syndromes with identified pathology	I	A	Strong
DRG stimulation is recommended for CRPS type I or type II of the lower extremity	I	A	Strong
DRG stimulation for CRPS type I or type II of the upper extremity requires more study	II-2	A	Strong
DRG stimulation for DPN may be effective based on limited data. Since there is good evidence for SCS, the use of DRG must be justified.	III	C	Strong
Evidence for DRG stimulation for non-diabetic peripheral neuropathy is limited; use should be determined on a case-by case basis.	III	B	Moderate
Evidence for DRG stimulation for chronic postoperative surgical pain is limited; use should be determined on a case-by-case basis.	III	C	Moderate
DRG stimulation for pelvic pain should be used under strict criteria depending on mechanism of injury and visceral/somatic designation. Psychologic comorbidity is a contraindication.	III	I	Moderate
DRG stimulation for groin pain is recommended.	II-2	B	Strong
DRG stimulation is superior to standard SCS for unilateral focal pain from CRPS type I or type II of the lower extremity	I	A	Strong
No evidence for DRG stimulation over SCS for other indications

CRPS: complex regional pain syndrome; DPN: diabetic peripheral neuropathy; DRG: dorsal root ganglion; NACC: Neuromodulation Appropriateness Consensus Committee; SCS: spinal cord stimulation.

National Institute for Health and Clinical Excellence

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 chronic pain (measuring at least 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.

In the same guidance, the National Institute for Health and Care Excellence stated that SCS was not recommended for chronic pain of ischemic origin except in the context of research.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Neurostimulator, implantable spinal cord stimulator, spinal neurostimulators, electrical nerve stimulators, implantable electrical nerve stimulators, spinal cord stimulator, dorsal column stimulator, angina, critical limb ischemia, pain management, Senza™ System HF10, Axium Neurostimulator System, wireless dorsal root ganglion neurostimulator, Freedom Spinal Cord Stimulator, BurstDR™ stimulation, Nevro Senza™, Genesis, Eon devices, Precision Spinal Cord Stimulator, Intellis™ Neurostimulator, RestoreSensor™ SureScan™ neurostimulator,  RestoreUltra™ SureScan™, RestoreAdvanced™ SureScan™ MRI neurostimulator, Algovita SCS System, Proclaim DRG (2nd generation) Neurostimulator System, Cordis Programmable Neural Stimulator Models 900a, EternaSpinal Cord Stimulation (SCS)System; Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation(SCS) Systems, Itrel, Synergy, Vanta Spinal Cord Stimulation Systems, Evoke SCS System, Nalu Neurostimulator System, Prospera Spinal Cord Stimulator, Inceptiv CL-Spinal Cord Stimulator.

APPROVED BY GOVERNING BODIES:

A large number of neurostimulator devices have been approved by the FDA through the premarket approval process under FDA product code: LGW (stimulator, spinal-cord, totally implanted for pain relief), PMP (Dorsal Root Ganglion Stimulator for Pain Relief), and GZB (Stimulator, Spinal-Cord, Implanted [Pain Relief]) (Table 4). In October 2016, the FDA approved BurstDR™ stimulation (St. Jude Medical), a clinician programmer application that provides intermittent "burst" stimulation for patients with certain St. Jude spinal cord stimulation devices.

Table 4. Premarket Approval Information for Spinal Cord and Dorsal Root Ganglion Stimulator Devices

Device	Manufacturer	Product code	Original approval date	Original PMA number	Indication
Algovita SCS System	Nuvectra Corporation	LGW	Nov 2015	P130028	Chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain.
Axium (1st generation) and Proclaim DRG (2nd generation) Neurostimulator System	Abbott Medical	PMP	Feb 2016	P150004	Moderate to severe chronic intractable pain of the lower limbs in adult patients with Types I and II CRPS
Cordis Programmable Neural Stimulator Models 900a	Cordis Corporation	LGW	Apr 1981a	P800040	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Freedom SCS	Stimwave Technologies	GZB	Aug 2016	K180981	Chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain
Genesis And Eon Family Neurostimulation (Ipg) System; Eterna Spinal Cord Stimulation (SCS) System;Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems	St. Jude Medical/ Abbott Medical	LGW; QRB	Nov 2001	P010032	Chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities.
Restore, Itrel, Synergy, Intellis, And Vanta Spinal Cord Stimulation Systems	Medtronic Neuromodulation	LGW	Nov 1984	P840001	Chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: • Failed Back Syndrome (FBS) or low back syndrome or failed back • Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk • Post laminectomy pain • Multiple back operations • Unsuccessful disk surgery • Refractory Degenerative Disk Disease (DDD)/herniated disk pain • Peripheral causalgia • Epidural fibrosis • Arachnoiditis or lumbar adhesive arachnoiditis • Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia • Diabetic peripheral neuropathy of the lower extremities
Evoke SCS System	Saluda Medical Pty Ltd	LGW	Feb 2022	P190002	Chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.
Senza SCS Systems	Nevro Corporation	LGW	May 2015	P130022	Chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain When programmed to include a frequency of 10 kHz: Chronic intractable pain of the lower limbs, including unilateral or bilateral pain, associated with diabetic neuropathy; non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery)
Nalu Neurostimulation System	Nalu Medical, Inc	GZB	Mar 2019	K183047	Chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain
Prospera Spinal Cord Stimulation (SCS) System Biotronik NRO, Inc	Prospera Spinal Cord Stimulation (SCS) System Biotronik NRO, Inc	LGW	March 2023	P210037	Chronic, intractable pain in the trunk and/or limbs, which may include unilateral or bilateral pain, resulting from any of the following: 1) Failed Back Syndrome (FBS) or low back syndrome or failed back; 2) Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or; 3) herniated disk; 4) Postlaminectomy pain; 5) Multiple back operations; 6) Unsuccessful disk surgery; 7) Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and; 8) surgical interventions; 9) Peripheral causalgia;10) Epidural fibrosis;11) Arachnoiditis or lumbar adhesive arachnoiditis; and12) Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgiai.
Inceptiv Closed-Loop Spinal Cord Stimulator	Medtronic Neuromodulation	LGW, QRB	April 2024	P840001	Chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain

CRPS:Complex regional pain syndrome; PMA: premarket approval; SCS: spinal cord stimulation.
a Withdrawn in 2016

In September 2020, the FDA released a letter to healthcare providers reminding them to conduct a trial stimulation period before implanting a spinal cord stimulator as the agency continues to receive reports of serious adverse effects associated with these devices. Between July 27, 2016 and July 27, 2020, the FDA received 107,728 medical device reports related to spinal cord simulators intended for pain including 497 associated with patient death, 77,937 with patient injury, and 29,924 with device malfunction. The most frequently reported patient problem codes were inadequate pain relief (28.1%), pain (15.2%), unexpected therapeutic effects (10.9%), infection (7.5%), and discomfort (5.9%). Additionally, the most frequently reported device problem codes were charging problems (11.2%), impedance (10.6%), migration (7.2%), battery problem (6.4%), and premature discharge of battery (4.2%). The FDA made the following recommendations for clinicians to consider:

• Conduct a trial stimulation as described in the device labeling to identify and confirm satisfactory pain relief before permanent implantation.
• Permanent spinal cord stimulation should only be implanted in patients who have undergone and passed a stimulation trial.
• Providers typically perform a stimulation trial on a patient for 3 to 7 days, and success is usually defined by a 50% reduction in pain symptoms. Inform patients about the risks of serious side effects and what to expect during the trial stimulation.
• Before implantation of any spinal cord stimulation, discuss the benefits and risks of the different types of implants and other treatment options, including magnetic resonance imaging compatibility of the devices.
• Before implantation, provide patients with the manufacturer's patient labeling and any other education materials for the device that will be implanted.
• Develop an individualized programming, treatment, and follow-up plan for spinal cord stimulation therapy delivery with each patient.
• Provide each patient with the name of the device manufacturer, model, and the unique device identifier of the implant received.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP: Special benefit consideration may apply.  Refer to member’s benefit plan.

CURRENT CODING:

CPT Codes:

63650	Percutaneous implantation of neurostimulator electrode array; epidural
63655	Laminectomy for implantation of neurostimulator electrode 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	Revision or removal of implanted spinal neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver
63688	Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling, with detachable connection to electrode array
95970	Electronic analysis of implanted neurostimulator pulse generator system (e.g. 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 (i.e. cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without programming
95971	; simple spinal cord, or peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming
95972	; complex spinal cord, or peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming

HCPCS Codes:

L8679	Implantable neurostimulator pulse generator, any type
L8680	Implantable neurostimulator electrode, each
L8685	Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686	Implantable neurostimulator pulse generator, single array, non-rechargeable, includes extension
L8687	Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688	Implantable neurostimulator pulse generator, dual array, non-rechargeable, includes extension

REFERENCES:

1. 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.
2. Al-Kaisy A, Palmisani S, Smith TE, et al. Long-Term Improvements in Chronic Axial Low Back Pain Patients Without Previous Spinal Surgery: A Cohort Analysis of 10-kHz High-Frequency Spinal Cord Stimulation over 36 Months. Pain Med.Jun 01 2018; 19(6): 1219-1226.
3. Aman MM, Mahmoud A, Deer T, et al. The American Society of Pain and Neuroscience (ASPN) Best Practices and Guidelines for the Interventional Management of Cancer-Associated Pain. J Pain Res. 2021; 14: 2139-2164. 
4. Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Rheum. Aug 2001; 45(4): 384-91. 
5. Beck ATS, R.A. Beck Depression Inventory. San Antonio, TX: Psychological Corporation; 1993.
6. 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.
7. Blonde L, Umpierrez GE, Reddy SS, et al. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update. Endocr Pract. Oct 2022; 28(10): 923-1049.
8. Bolash R, Creamer M, Rauck R, et al. Wireless High-Frequency Spinal Cord Stimulation (10 kHz) Compared with Multiwaveform Low-Frequency Spinal Cord Stimulation in the Management of Chronic Pain in Failed Back Surgery Syndrome Subjects: Preliminary Results of a Multicenter, Prospective Randomized Controlled Study. Pain Med. Oct 01 2019; 20(10): 1971-1979. 
9. Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. Mar 1994; 23(2): 129-38. 
10. Curran SL, Andrykowski MA, Studts JL. Short Form of the Profile of Mood States (POMS-SF): Psychometric information. Psychol Assess 1995;7:80-83.
11. De Andres J, Monsalve-Dolz V, Fabregat-Cid G, et al. Prospective, randomized blind effect-on-outcome study of conventional vs high frequency spinal cord stimulation in patients with pain and disability due to failed back surgery syndrome. Pain Med. Dec 1 2017; 18(12):2401-2421. 
12. Deer T, Gilligan C, Falowski S, et al. Treatment of Refractory Low Back Pain Using Passive Recharge Burst in Patients Without Options for Corrective Surgery: Findings and Results From the DISTINCT Study, a Prospective Randomized Multicenter Controlled Trial. Neuromodulation. Oct 2023; 26(7): 1387-1399.
13. Deer TR, Hunter CW, Mehta P, et al. A Systematic Literature Review of Dorsal Root Ganglion Neurostimulation for the Treatment of Pain. Pain Med. Aug 01 2020; 21(8): 1581-1589.
14. 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. 
15. Deer T, Pope J, Hunter C, et al. Safety Analysis of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Pain. Neuromodulation. Feb 2020; 23(2): 239-244.
16. Deer T, Slavin KV, Amirdelfan K, et al. Success Using Neuromodulation with BURST (SUNBURST) Study: results from a prospective, randomized controlled trial using a novel burst waveform. Neuromodulation. Jan 2018; 21(1):56-66.
17. Deer, TT, Pope, JJ, Hunter, CC, Falowski, SS, Kapural, LL, Kramer, JJ, Levy, RR. Safety Analysis of Dorsal Root Ganglion Stimulation in the Treatment of Chronic Pain. Neuromodulation, 2019 Mar 13.
18. Deer TR, Pope JE, Lamer TJ, et al. The Neuromodulation Appropriateness Consensus Committee on Best Practices for Dorsal Root Ganglion Stimulation. Neuromodulation. Jan 2019; 22(1):1-35.
19. De Ridder D, Vanneste S, Plazier M, et al. Burst spinal cord stimulation: toward paresthesia-free pain suppression. Neurosurgery. May 2010; 66(5):986-990.
20. 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.
21. de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: A multicentre randomized clinical trial. Pain. Aug 29 2014.
22. D'Souza RS, Kubrova E, Her YF, et al. Dorsal Root Ganglion Stimulation for Lower Extremity Neuropathic Pain Syndromes: An Evidence-Based Literature Review. Adv. Ther. Oct 2022; 39(10): 4440-4473.
23. 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. Jul 2016; 25(7):1771-1777.
24. Duarte RV, Nevitt S, Maden M, et al. Spinal cord stimulation for the management of painful diabetic neuropathy: a systematic review and meta-analysis of individual patient and aggregate data. Pain. Nov 01 2021; 162(11): 2635-2643.
25. Dworkin RH, O'Connor AB, Kent J et al. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain 2013; 154(11):2249-61. 
26. Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. Jan 2005; 113(1-2): 9-19.
27. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. Feb 2008; 9(2): 105-21.
28. Eldabe S, Duarte R, Gulve A, et al. Analgesic Efficacy of "Burst" and Tonic (500 Hz) Spinal Cord Stimulation Patterns: A Randomized Placebo-Controlled Crossover Study. Neuromodulation. Apr 2021; 24(3): 471-478. 
29. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). Nov 15 2000; 25(22): 2940-52; discussion 2952. 
30. Food and Drug Administration. Inceptiv Closed Loop Spinal Cord Stimulator: Premarket Approval. wwwaccessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P840001S512.
31. Food and Drug Administration. Cordis Programmable Neural Stimulator: Premarket Approval.
32. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Axium Neurostimulator System. 2016.www.accessdata.fda.gov/cdrh_docs/pdf15/P150004b.pdf.
33. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Senza Spinal Cord Stimulation (SCS) System 2015.
34. 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. 
35. Hara S, Andresen H, Solheim O, et al. Effect of Spinal Cord Burst Stimulation vs Placebo Stimulation on Disability in Patients With Chronic Radicular Pain After Lumbar Spine Surgery: A Randomized Clinical Trial. JAMA. Oct 18 2022; 328(15): 1506-1514.
36. Head J, Mazza J, Sabourin V, et al. Waves of Pain Relief: A Systematic Review of Clinical Trials in Spinal Cord Stimulation Waveforms for the Treatment of Chronic Neuropathic Low Back and Leg Pain. World Neurosurg. Nov 2019; 131:264-274.e3.
37. Henson JV, Varhabhatla NC, Bebic Z, et al. Spinal Cord Stimulation for Painful Diabetic Peripheral Neuropathy: A Systematic Review. Pain Ther. Dec 2021; 10(2): 895-908.
38. Hoelzer BC, Edgar D, Lu SP, et al. Indirect Comparison of 10 kHz Spinal Cord Stimulation (SCS) versus Traditional Low-Frequency SCS for the Treatment of Painful Diabetic Neuropathy: A Systematic Review of Randomized Controlled Trials. Biomedicines. Oct 19, 2022; 10(10).
39. 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.
40. Hunter CW, Deer TR, Jones MR, et al. Consensus Guidelines on Interventional Therapies for Knee Pain (STEP Guidelines) from the American Society of Pain and Neuroscience. J Pain Res. 2022; 15: 2683-2745.
41. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
42. Kapural L, Jameson J, Johnson C, et al. Treatment of nonsurgical refractory back pain with high-frequency spinal cord stimulation at 10kHz: 12-month results of a pragmatic, multicenter, randomized controlled trial. J Neurosurg Spine. Feb 11 2022: 1-12.
43. Kapural L, Peterson E, Provenzano DA, et al. Clinical evidence for spinal cord stimulation for failed back surgery syndrome (FBSS): systematic review. Spine (Phila Pa 1976). Jul 15 2017; 42 Suppl 14:S61-S66.
44. 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.
45. 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.
46. Kemler MA, Barendse GA, van Kleef M, et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. Aug 31 2000; 343(9): 618-24.
47. Kemler MA, De Vet HC, Barendse GA, et al. The effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years' follow-up of the randomized controlled trial. Ann Neurol. Jan 2004; 55(1): 13-8.
48. Kemler MA, de Vet HC, Barendse GA, et al. Effect of spinal cord stimulation for chronic complex regional pain syndrome Type I: five-year final follow-up of patients in a randomized controlled trial. J Neurosurg. Feb 2008; 108(2): 292-8.
49. Kerns RD, Turk DC, Rudy TE. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain. Dec 1985; 23(4): 345-356.
50. Kosinski M, Zhao SZ, Dedhiya S, et al. Determining minimally important changes in generic and disease-specific healthrelated quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum. Jul 2000; 43(7): 1478-8.
51. Klomp HM, Spincemaille GH, Steyerberg EW, et al. Spinal-cord stimulation in critical limb ischaemia: a randomised trial. ESES Study Group. Lancet. Mar 27 1999; 353(9158): 1040-4.
52. Klomp HM, Steyerberg EW, Habbema JD, et al. What is the evidence on efficacy of spinal cord stimulation in (subgroups of) patients with critical limb ischemia?. Ann Vasc Surg. 2009; 23(3): 355-63.
53. Kriek N, Groeneweg JG, Stronks DL, et al. Preferred frequencies and waveforms for spinal cord stimulation in patients with complex regional pain syndrome: A multicentre, double-blind, randomized and placebo-controlled crossover trial. Eur J Pain. Mar 2017; 21(3):507-519. 
54. Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. Nov 2007; 132(1-2): 179-88.
55. Kumar K, Taylor RS, Jacques L, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. Oct 2008; 63(4): 762-70; discussion 770.
56. Lanza GA, Barone L, Di Monaco A. Effect of spinal cord stimulation in patients with refractory angina: evidence from observational studies. Neuromodulation 2012; 15(6): 542-9.
57. Lanza GA, Grimaldi R, Greco S et al. Spinal cord stimulation for the treatment of refractory angina pectoris: a multicenter randomized single-blind study (the SCS-ITA trial). Pain 2011; 152(1):45-52.
58. Lihua P, Su M, Zejun Z et al. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev. Feb 28 2013; 2:CD009389.
59. Manchikanti L, Abdi S, Atluri S et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician 2013; 16(2 Suppl):S49-283. 
60. Mekhail N, Deer TR, Kramer J, et al. Paresthesia-Free Dorsal Root Ganglion Stimulation: An ACCURATE Study SubAnalysis. Neuromodulation. Feb 2020; 23(2): 185-195.
61. Mekhail N, Levy RM, Deer TR, et al. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. Feb 2020; 19(2): 123-134.
62. Mekhail NA, Levy RM, Deer TR, et al. ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesth Pain Med. Aug 27 2023.
63. Mekhail NA, Mathews M, Nageeb F et al. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract 2011; 11(2):148-53.
64. Moman RN, Peterson AA, Maher DP, et al. Infectious Complications of Dorsal Root Ganglion Stimulation: A Systematic Review and Pooled Analysis of Incidence. Neuromodulation. Oct 2022; 25(7): 956-964. 
65. National Institute for Health and Care Excellence (NICE). Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin [TA159]. 2008; www.nice.org.uk/guidance/ta159.
66. North RB, Kidd DH, Farrokhi F, et al. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005; 56(1): 98-106; discussion 106-7.
67. O'Connell NE, Ferraro MC, Gibson W, et al. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. Dec 02 2021; 12(12): CD013756.
68. O'Connell NE, Wand BM, McAuley J, et al. Interventions for treating pain and disability in adults with complex regional pain syndrome. Cochrane Database Syst Rev. Apr 30 2013(4):Cd009416. 
69. Ostelo RW, Deyo RA, Stratford P, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976). Jan 01 2008; 33(1): 90-4.
70. Pan X, Bao H, Si Y, et al. Spinal cord stimulation for refractory angina pectoris: a systematic review and meta-analysis. Clin J Pain. Jun 2017; 33(6): 543-551.
71. Patel NP, Jameson J, Johnson C, et al. Durable responses at 24 months with high-frequency spinal cord stimulation for nonsurgical refractory back pain. J Neurosurg Spine. Feb 01 2024; 40(2): 229-239.
72. Peng L, Min S, Zejun Z, et al. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev. Jun 29 2015; 6:CD009389.
73. 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.
74. Petersen EA, Stauss TG, Scowcroft JA, et al. Durability of High-Frequency 10-kHz Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy Refractory to Conventional Treatments: 12-Month Results From a RandomizedControlled Trial. Diabetes Care. Jan 01 2022; 45(1): e3-e6.
75. Petersen EA, Stauss TG, Scowcroft JA, et al. High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients with Refractory Painful Diabetic Neuropathy: 12-Month Results from a Randomized Controlled Trial. Mayo Clin Pros Innu Qual Outcomes. Aug 2022; 6(4): 347-360. 
76. Petersen EA, Stauss TG, Scowcroft JA, et al. Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. Diabetes Res Clin Pract. Sep 2023; 203: 110865.
77. Piedade, GG, Vesper, JJ, Chatzikalfas, AA, Slotty, PP. Cervical and High-Thoracic Dorsal Root Ganglion Stimulation in Chronic Neuropathic Pain. Neuromodulation, 2019 Jan 9.
78. Raghu ALB, Parker T, Aziz TZ, et al. Invasive Electrical Neuromodulation for the Treatment of Painful Diabetic Neuropathy: Systematic Review and Meta-Analysis. Neuromodulation. Jan 2021; 24(1): 13-21.
79. Rauck RL, Loudermilk E, Thomson SJ, et al. Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Pain Manag. Feb 2023; 13(2): 115-127.
80. Rigoard P, Basu S, Desai M, et al. Multicolumn spinal cord stimulation for predominant back pain in failed back surgery syndrome patients: a multicenter randomized controlled trial. Pain. Jun 2019; 160(6): 1410-1420.
81. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain. J Pain Res. 2022; 15: 3729-3832.
82. Schu S, Slotty PJ, Bara G, et al. A prospective, randomized, 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.
83. Sivanesan, EE, Bicket, MM, Cohen, SS. Retrospective analysis of complications associated with dorsal root ganglion stimulation for pain relief in the FDA MAUDE database. Reg Anesth Pain Med, 2019 Jan 15; 44(1).
84. 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):3016-24.
85. Strand NH, Burkey AR. Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation. J Diabetes Sci Technol. Mar 2022; 16(2): 332-340.
86. 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. Jul 2014; 16(7):788-795. 
87. Traeger AC, Gilbert SE, Harris IA, et al. Spinal cord stimulation for low back pain. Cochrane Database Syst Rev. Mar 07 2023; 3(3): CD014789.
88. 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.
89. Turk DC, Dworkin RH, Allen RR, et al. Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain. Dec 2003; 106(3):337-345.
90. Ubbink DT, Vermeulen H. Spinal cord stimulation for non-reconstruct able chronic critical leg ischaemia. Cochrane Database Syst Rev. Feb 28 2013; 2013(2): CD004001.
91. U.S. Food and Drug Administration. Conduct a trial stimulation period before implanting a spinal cord stimulator (SCS) -letter to health care providers. September 3, 2020. www.fda.gov/medical-devices/letters-health-careproviders/conduct-trial-stimulation-period-implanting-spinal-cord-stimulator-scs-letter-health-care-providers.
92. Visnjevac O, Costandi S, Patel BA, et al. A comprehensive outcome-specific review of the use of spinal cord stimulation for complex regional pain syndrome. Pain Pract. Apr 2017; 17(4):533-545.
93. Vuka, II, Marciu, TT, Doenovi, SS, Ferhatovi Hamzi, LL, Vui, KK, Sapunar, DD, Puljak, LL. Neuromodulation with electrical field stimulation of dorsal root ganglion in various pain syndromes: a systematic review with focus on participant selection. J Pain Res, 2019; 12: 803-830.
94. 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. 
95. Wells GA, Tugwell P, Kraag GR, et al. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol. Mar 1993; 20(3): 557-60.
96. Zhou M, Zhong H, Xing C, et al. Comparison of clinical outcomes associated with spinal cord stimulation (SCS) or conventional medical management (CMM) for chronic pain: a systematic review and meta-analysis. Eur Spine J. Jun 2023; 32(6): 2029-2041.
97. 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.
98. Zipes DP, Svorkdal N, Berman D et al. Spinal cord stimulation therapy for patients with refractory angina who are not candidates for revascularization. Neuromodulation 2012; 15(6):550-8; discussion 558-9.
99. Zuidema X, van Daal E, van Geel I, et al. Long-term Evaluation of Spinal Cord Stimulation in Patients With Painful Diabetic Polyneuropathy: An Eight-to-Ten-Year Prospective Cohort Study. Neuromodulation. Jul 2023; 26(5): 1074-1080.

POLICY HISTORY:

Medical Policy Group, November 2008 (4)

Medical Policy Administration Committee, December 2008

Available for comment November 25, 2008-January 8, 2009

Medical Policy Group, September 2010, (1): No change in coverage statement, Key Points updated, policy title change

Medical Policy Administration Committee, October 2010

Available for comment October 21 through December 6, 2010

Medical Policy Group, December 2011 (1): 2012 Code Updates – verbiage change on 95970, 95971, 95972, and 95973

Medical Policy Group, January 2012 (1): Update to Key Points related to MPP update; no change in policy statement

Medical Policy Panel, January 2013

Medical Policy Group, April 2013 (1):  2013 Update to Key Points and References; minor change in policy statement wording (changed “chronic ischemic limb” to “critical ischemic limb”)

Medical Policy Panel, January 2014

Medical Policy Group, January 2014 (1): Update to Policy, Key Points and References related to change in policy statement to noncoverage of angina pain; update to Current Codes with addition of HCPCS code L8679 effective 01/01/2014

Medical Policy Administration Committee, February 2014

Available for comment February 20 through April 7, 2014

Medical Policy Group, May 2014 (5): 2014 Coding Update:  Deleted code L8680 effective July 1, 2014.

Medical Policy Group, June 2014 (5): Quarterly 2014 Coding Update:  Code L8680 did not delete added back to policy under current codes.

Medical Policy Panel, January 2015

Medical Policy Group, January 2015 (6): 2015 Updates – Description, Key Points and References, no change to policy statement

Medical Policy Group, November 2015: 2016 Annual Coding Update. Created previous coding section and moved CPT code 95973 from current coding to previous coding. Revised CPT code 95972.

Medical Policy Group, January 2016 (6): Update to Key Words and Approved by Governing Bodies to add Senza System.

Medical Policy Panel, April 2016

Medical Policy Group, April 2016 (6): Updates to Description, Policy, Key Points, Key Words, Approved by Governing Bodies and References; policy statement updated to add high frequency spinal cord stimulation as investigational for the treatment of severe and chronic pain of the trunk or limbs.

Medical Policy Administration Group, April 2016

Available for comment April 19 through June 2, 2016

Medical Policy Group, May 2016 (5): Removed reference to high frequency spinal cord stimulation from the policy.  Added information: The available RCT comparing standard and high frequency stimulation is suggestive of a benefit to high frequency stimulation.  Updates due to comments during the comment period Policy removed off of draft since policy statement went back to original statement.

Medical Policy Panel, April 2017

Medical Policy Group, June 2017 (6): Updates to Policy statement, added “Wireless injectable dorsal root ganglion is considered not medically necessary and investigational for all indications.”, Description, Key Points, Key Words, Practice Guidelines, Governing Bodies, Coding and References.

Medical Policy Panel, July 2017

Medical Policy Group, August 2017 (6): Correction to description of recently cleared devices in Regulatory Status section. “Wireless injectable” removed from policy statement on dorsal root ganglion neurostimulation; Updates to Description, Key Points, and Governing Bodies.

Medical Policy Panel, April 2018

Medical Policy Group, May 2018 (6): Updates to Description, Key Points and References.

Medical Policy Panel, April 2019

Medical Policy Group, May 2019 (3): 2019 Updates to Description, Key Points, Practice Guidelines and Position Statements, References and Key Words: added: Intellis™ Neurostimulator. Policy statement changed to open up coverage for dorsal root ganglion neurostimulation. The policy was posted as draft with effective date of May 29, 2019 with comment period through July 13, 2019.

Medical Policy Panel, April, 2020

Medical Policy Group, May 2020 (3): 2020 Updates to the Key points, References and Key Words: added: RestoreSensor™ SureScan™ neurostimulator,  RestoreUltra™ SureScan™, RestoreAdvanced™ SureScan™ MRI neurostimulator. No changes to policy statement or intent. Title changed from Spinal Cord Stimulation to Spinal Cord and Dorsal Root Ganglion Stimulation.

Medical Policy Panel, April, 2021

Medical Policy Group, May 2021 (3): 2021 Updates to Key Points, Practice Guidelines and Position Statements, and References. Policy statement updated to remove “not medically necessary,” no change to policy statement or intent.

Medical Policy Panel, April 2022

Medical Policy Group, May 2022 (3): 2022 Updates to Key Points, Approved By Governing Bodies, Practice Guidelines and Position Statements, and References. Policy Statement clarifications made to list out covered diagnoses and non-covered diagnoses more clearly. Policy Guidelines removed and information placed in policy statement for clarification. No changes to policy statement or intent.

Medical Policy Panel, April 2023

Medical Policy Group, May 2023 (3): 2023 Updates to Description, Key Points, Approved By Governing Bodies, Practice Guidelines and Position Statements, Benefit Applications, and References. Removed Previous Coding Section. Key Words added: Algovita SCS System, Proclaim DRG (2nd generation) Neurostimulator System, Cordis Programmable Neural Stimulator Model 900a, Eterna Spinal Cord Stimulation (SCS)System; Prodigy SCS System, Proclaim, and Proclaim XR Spinal Cord Stimulation(SCS) Systems, Itrel SCS System, Synergy SCS System, Vanta Spinal Cord Stimulation System, Evoke SCS System. No changes to policy statement or intent.

Medical Policy Group, November 2023: 2024 Annual CPT Coding update. Revised codes 63685, 63688.

Medical Policy Panel, April 2024

Medical Policy Group, April 2024 (3): Updates to Description, Key Points, and References.  Approved by Governing Bodies devices added: Nalu Neurostimulator System and Prospera Spinal Cord Stimulator. Key Words added: Nalu Neurostimulator System, Prospera Spinal Cord Stimulator. No changes to policy statement or intent.

Medical Policy Group, May 2024 (3): Updated References and  Approved  by Governing Bodies device added: Inceptiv CL-SCS. Key Words added: Inceptiv CL-SCS.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.