Latest Review Date: May 2025

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 (5 or more on a 10-point scale):
  • 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.

Spinal cord and dorsal root ganglion stimulation are 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 an upgrade of existing, properly functioning equipment, even if the 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 patients who are poor candidates for revascularization and in individuals with refractory chest pain.

Spinal Cord Stimulation

Spinal cord stimulation (SCS, 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 individual’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.

Dorsal Root Ganglion Neurostimulation

Dorsal root ganglion neurostimulation (or dorsal root ganglion stimulation, DRGS) uses the same epidural approach technique as spinal cord stimulation but targets a different anatomical target, the dorsal root ganglion. Dorsal root ganglia, situated within the spine as clusters of nerve cell bodies, serve as the "sensory gate" for pain signals entering the spinal cord. DRGS seeks to modulate the activity of these nerve cell bodies, potentially intercepting or diminishing pain signals before they reach the spinal cord. DRGS proves particularly efficacious for localized or chronic nerve pain conditions, such as complex regional pain syndrome, post-amputation pain, and pain following specific surgical procedures. It allows for more precise targeting of specific nerves and pain areas compared to SCS, potentially leading to better pain relief with fewer side effects. Moreover, DRGS may induce less paresthesia (tingling or numbness) than SCS, owing to its focused and precise stimulation. Recovery from DRGS implantation typically spans 6-8 weeks, during which patients are advised to refrain from strenuous activities.

Traditional SCS 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 consist 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 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, patients 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 (PGI) 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 March 12, 2025.

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 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 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 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 technology results in an improvement in the net health outcome.

Critical Limb Ischemia

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 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 technology results in an improvement in the net health outcome.

Heart Failure

For individuals who have heart failure receive spinal cord stimulation, the evidence includes a systematic review. Relevant outcomes are overall survival, symptoms, functional outcomes, quality of life, morbid events, hospitalizations, and treatment-related morbidity. Four studies (including 2 RCTs) with a total of 125 patients were selected. Two studies reported improvements in New York Heart Association classification, and quality of life parameters, while only one study showed positive changes in left ventricular ejection function and VO2 max. No studies found significant changes in NT-proBNP (N-terminal Pro-Brain Natriuretic Peptide) following SCS therapy. Discrepancies in results could be due to methodological variations and induction technique diversity. Further studies are needed to develop a solid approach for employing SCS in heart failure patients.

Cancer-Related Pain

For individuals who have cancer-related pain who receive spinal cord stimulation, the evidence includes a systematic review 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 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 Regional Anesthesia and Pain Medicine

In 2023, American Society of Regional Anesthesia and Pain Medicine published evidence-based consensus guidelines on patient selection and trial stimulation for SCS therapy for chronic non-cancer pain.  Recommendations included that SCS trial should be performed before a definitive SCS implant except in anginal pain (grade B). All patients must be screened with an objective validated instrument for psychosocial factors, and this must include depression (grade B). Despite some limitations, a trial helps patient selection and provides patients with an opportunity to experience therapy. These recommendations are expected to guide practicing physicians and other stakeholders and should not be mistaken as practice standards. Physicians should continue to make their best judgment based on individual patient considerations and preferences.

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".  No updates have been made since the original publication.

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

National Institute for Health and Clinical Excellence

In 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, which was reaffirmed in 2014. The NICE recommended spinal cord stimulation as a treatment option for adults with chronic pain of neuropathic origin (measuring at least 50 mm on a 0–100 mm visual analog scale (VAS) that continues 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 spinal cord stimulation 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 and Prospera 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 3. FDA Cleared or approved for Spinal Cord and Dorsal Root Ganglion Stimulation

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 (now Curonix)	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
Precision SCS Systems	Boston Scientific Corporation	LGW	Apr 2004	P030017	Chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, Types 1 and 2 CRPS, intractable low back pain and leg pain
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	Mar 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.

CRPS: Complex regional pain syndrome; PMA: premarket approval; SCS: spinal cord stimulation. 

a Withdrawn in 2016¹

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 contracts: 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

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22. 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.
23. 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.
24. 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.
25. 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.
26. 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.
27. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). Nov 15 2000; 25(22): 2940-52; discussion 2952.
28. Food and Drug Administration. Cordis Programmable Neural Stimulator: Premarket Approval.
29. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Axium Neurostimulator System. 2016.
30. Food and Drug Administration. Summary of Safety and Effectiveness Data (SSED): Senza Spinal Cord Stimulation (SCS) System 2015.
31. 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.
32. 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.
33. 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.
34. 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.
35. 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).
36. 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.
37. Huygen FJPM, Soulanis K, Rtveladze K, et al. Spinal Cord Stimulation vs Medical Management for Chronic Back and Leg Pain: A Systematic Review and Network Meta-Analysis. JAMA Netw Open. Nov 04 2024; 7(11): e2444608.
38. 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.
39. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
40. 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.
41. 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.
42. 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.
43. 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.
44. 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.
45. 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.
46. 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.
47. Kosinski M, Zhao SZ, Dedhiya S, et al. Determining minimally important changes in generic and disease-specific health related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum. Jul 2000; 43(7): 1478-8.
48. 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.
49. 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.
50. 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.
51. 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.
52. 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.
53. 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.
54. 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.
55. Lihua P, Su M, Zejun Z et al. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev 2013; 2:CD009389.
56. 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.
57. Mattie R, Lin AB, Bhandal H, et al. Spinal cord stimulation for the treatment of complex regional pain syndrome: A systematic review of randomized controlled trials. Interv Pain Med. Dec 2024; 3(4): 100527.
58. 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.
59. 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.
60. 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.
61. 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.
62. 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.
63. 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.
64. 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.
65. 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.
66. 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.
67. 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.
68. Pan X, Bao H, Si Y, et al. Spinal cord stimulation for refractory angina pectoris: a systematic review and meta-analysis. Clin J Pain. Nov 21 2016.
69. 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.
70. Peng L, Min S, Zejun Z, et al. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev. 2015; 6:CD009389.
71. 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.
72. 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.
73. 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.
74. 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.
75. Piedade, GG, Vesper, JJ, Chatzikalfas, AA, Slotty, PP. Cervical and High-Thoracic Dorsal Root Ganglion Stimulation in Chronic Neuropathic Pain. Neuromodulation, 2019 Jan 9.
76. 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
77. 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.
78. 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.
79. 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.
80. 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.
81. Shanthanna H, Eldabe S, Provenzano DA, et al. Evidence-based consensus guidelines on patient selection and trial stimulation for spinal cord stimulation therapy for chronic non-cancer pain. Reg Anesth Pain Med. Jun 2023; 48(6): 273-287.
82. Sivanesan E, Bicket MC, Cohen SP. Retrospective analysis of complications associated with dorsal root ganglion stimulation for pain relief in the FDA MAUDE database. Reg Anesth Pain Med. Jan 2019; 44(1): 100-106.
83. 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.
84. 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.
85. Sun S, Yin J, Wei H, et al. Long-Term Efficacy and Safety of High-Frequency Spinal Stimulation for Chronic Pain: A Meta-Analysis of Randomized Controlled Trials. Clin J Pain. Jul 01 2024; 40(7): 415-427.
86. 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.
87. 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.
88. 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.
89. Ubbink DT, Vermeulen H. Spinal cord stimulation for non-reconstruct able chronic critical leg ischaemia. Cochrane Database Syst Rev 2013; 2:CD004001.
90. 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.
91. 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 Mar 19; 12:803-830.
92. 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.
93. 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.
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95. 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.
96. 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):550-9.
97. 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. Dec 30 2022.

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, Approved by Governing Bodies, and References.  Key Words added: Nalu Neurostimulator System and Prospera Spinal Cord Stimulator. No changes to policy statement or intent.

Medical Policy Panel, April 2025

Medical Policy Group, May 2025 (9): Updates to Description, Key Points, Approved by Governing Bodies, and References. Policy statement clarification. Removed wording “*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”. Added clarification in criteria “5 or more on a 10-point scale)”.   No changes to policy statement or intent.

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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.