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Spinal Cord and Dorsal Root Ganglion Stimulation

Policy Number: MP-328

Latest Review Date: May 2022

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 one 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 patient’s record:

  • The implantation of the stimulator is used only as a late or last resort for patients 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 patient; and
  • All of the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment, training, and follow-up of the patient 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

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 patients who are poor candidates for revascularization and in patients with refractory chest pain.

Spinal Cord Stimulation

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

SCS 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 patients with refractory chest pain.

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

The patient’s pain distribution pattern dictates at what level in the spinal cord the stimulation lead is placed. The pain pattern may influence the type of device used; for example, a lead with eight electrodes may be selected for those with complex pain patterns or bilateral pain. Implantation of the spinal cord stimulator is typically a two-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 SCS devices use electrical stimulation with a frequency on the order of 100 to 1000 Hz. In 2015, the U.S. Food and Drug Administration (FDA) approved an SCS device, using a higher frequency (10,000 Hz) than predicate devices through the premarket approval process. High-frequency stimulation is proposed to be associated with fewer paresthesias, which are a recognized effect of SCS. In addition, in 2016, FDA approved a clinician programmer “app” that allows an SCS 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 SCS 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.

The occurrence of adverse events related to spinal cord stimulation have been reported to occur in 30% to 40% of cases. Adverse events can be either hardware-related or biological. Hardware-related complications include lead migration or lead failure or fracture. Complications include infection and pain. However, severe complications are rare, including dural puncture headache (estimated incidence, up to 0.3%) and neurological damage (estimated incidence, 0.25%).

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 complications consisted 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 frequency 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 required 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

KEY POINTS:

The most recent literature search was through February 16, 2022.

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 RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Available RCTs are heterogeneous regarding underlying diagnoses in select patient populations. However, the trials including patients 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 patients 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 four 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 patients 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 patients 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 (n=66) did not find significant differences between groups but might have been underpowered to do so. T The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

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 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).

International Association for the Study of Pain

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

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 FBSS, after exhausting multiple conservative and interventional modalities".

American Society of Anesthesiologists

The American Society of Anesthesiologists' Task Force and the American Society of Regional Anesthesia and Pain Management (2011) updated and published guidelines for chronic pain management. The guideline concluded that SCS "may be used in the multimodal treatment of persistent radicular pain in patients who have not responded to other therapies" and that SCS "may also be considered for other selected patients (e.g., CRPS, peripheral neuropathic pain, peripheral vascular disease, and postherpetic neuralgia."

International Neuromodulation Society

The International Neuromodulation Society 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 3 summarizes the consensus recommendations on the use of DRG stimulation. Additional recommendations on the DRG stimulation procedure are provided in the publication.

Table 3. 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

APPROVED BY GOVERNING BODIES:

The U.S. Food and Drug Administration (FDA) have approved a large number of neurostimulator devices, through the premarket approval (PMA) process. Examples of fully-implantable SCS devices approved through the PMA process include the Cordis programmable neurostimulator (Cordis Corp., Downers Grove, IL), was approved in 1981, the Itrel® (Medtronic, Inc, Minneapolis, MN), approved in 1984, the Genesis and Eon devices ( St. Jude Medical) and in 2001 the Precision Spinal Cord Stimulator (Advanced Bionics, LLC., Switzerland), approved in 2004.

In May 2015, the FDA approved the Nevro Senza™ Spinal Cord Stimulator (Nevro Corp., Menlo Park, CA), a totally-implantable neurostimulator device for the following indications: “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.” This device uses a higher frequency of electrical stimulation (10 kHz) than standard devices.

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

In August 2017, the FDA through the premarket approval process approved the PrecisionTM Spinal Cord Stimulator (Boston Scientific).

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

63688          

Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling

63685

Revision or removal of implanted spinal neurostimulator pulse generator or receiver

 

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

PREVIOUS CODING:

CPT Codes:

95973

; complex spinal cord, or peripheral (i.e., peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming, each additional 30 minutes after first hour (list separately in addition to code for primary procedure) (Deleted effective 01/01/2016)

 

 

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  31. 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.
  32. 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):105-121.
  33. Dworkin RH, O'Connor AB, Kent J et al. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain 2013; 154(11):2249-61.
  34. Eddicks S, et al. Thoracic spinal cord stimulation improves functional status and relieves symptoms in patients with refractory angina pectoris: The first placebo-controlled randomized study. Heart, May 2007; 93(5): 585-590.
  35. Ekre O, Eliasson T, Norrsell H et al. Long-term effects of spinal cord stimulation and coronary artery bypass grafting on quality of life and survival in the ESBY study. Eur Heart J 2002; 23(24):1938-45.
  36. 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. Nov 29 2020.
  37. Eldabe S, Thomson S, Duarte R, et al. The effectiveness and cost-effectiveness of spinal cord stimulation for refractory angina (RASCAL study): a pilot randomized controlled trial. Neuromodulation. Jan 2016; 19(1):60-70.
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  41. Frey ME, Manchikanti L, Benyamin RM, et al. Spinal cord stimulation for patients with failed back surgery syndrome: A systematic review. Pain Physician 2009; 12: 379-397.
  42. 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.
  43. Hautvast RW, Blanksma PK, DeJongste MJ, et al. Effect of spinal cord stimulation on myocardial blood flow assessed by positron emission tomography in patients with refractory angina pectoris. Am J Cardiol 1996; 77:462-467.
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  54. 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. Neurosurgery. Nov 2016; 79(5):675-684.
  55. Kemler MA, Barendse GA, van Kleef M et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med 2000; 343(9):618-24.
  56. 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 2004; 55(1):13-18.
  57. 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 2008; 108(2):292-298.
  58. Kerns RD, Turk DC, Rudy TE. The West Haven-Yale Multidimensional Pain Inventory (WHYMPI). Pain. Dec 1985; 23(4):345-356.
  59. Klomp HM, Spincemaille GH, Steyerberg EW et al. Spinal cord stimulation in critical limb ischemia: a randomized trial. Lancet 1999; 353(9158):1040-4.
  60. Klomp HM, Steyerberg EW, van Urk H et al. ESES Study Group. Spinal cord stimulation is not cost-effective for non-surgical management of critical limb ischaemia. Eur J Vasc Endovasc Surg. 2006; 31(5):500-8.
  61. 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, May-June 2009; 23(3): 355-363.
  62. 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):1478-1487.
  63. 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.
  64. 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 2007; 132(1-2):179-88.
  65. 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):762-770; discussion 770.
  66. 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.
  67. 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.
  68. Liem L, Russo M, Huygen FJ, et al. One-year outcomes of spinal cord stimulation of the dorsal root ganglion in the treatment of chronic neuropathic pain. Neuromodulation. Jan 2015; 18(1):41-48; discussion 48-49.
  69. Lihua P, Su M, Zejun Z et al. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev 2013; 2:CD009389.
  70. Mailis A, Taenzer P. Evidence-based guideline for neuropathic pain interventional treatments: spinal cord stimulation, intravenous infusions, epidural injections and nerve blocks. Pain Res Manag 2012; 17(3):150-8.
  71. 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.
  72. Mannheimer C, Eliasson T, Augustinsson LE et al. Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris: the ESBY study. Circulation 1998; 97(12):1157-63.
  73. Mannheimer C, et al. Effects of spinal cord stimulation in angina pectoris induced by pacing: Possible mechanisms of action. BMJ, August 1993; 307(6902): 477-480.
  74. McNab D, Khan SN, Sharples LD et al. An open label, single-centre, randomized trial of spinal cord stimulation vs. percutaneous myocardial laser revascularization in patients with refractory angina pectoris: the SPiRiT trial. Eur Heart J 2006; 27(9):1048-53.
  75. 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.
  76. Mekhail, NN, Deer, TT, Kramer, JJ, Poree, LL, Amirdelfan, KK, Grigsby, EE, Staats, PP, Burton, AA, Burgher, AA, Scowcroft, JJ, Golovac, SS, Kapural, LL, Paicius, RR, Pope, JJ, Samuel, SS, McRoberts, WW, Schaufele, MM, Kent, AA, Raza, AA, Levy, RR. Paresthesia-Free Dorsal Root Ganglion Stimulation: An ACCURATE Study Sub-Analysis. Neuromodulation, 2019 Mar 13.
  77. Murphy DF and Giles KE. Dorsal column stimulation for pain relief from intractable angina pectoris. Pain 1987; 28: 365-368.
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  80. North RB, Kidd DH, Lee MS et al. A prospective, randomized study of spinal cord stimulation versus reoperation for failed back surgery syndrome: Initial results. Stereotact Funct Neurosurg 1994; 62(1-4):267-72.
  81. 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.
  82. 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 1 2008; 33(1):90-94.
  83. 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.
  84. Peng L, Min S, Zejun Z, et al. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev. 2015; 6:CD009389.
  85. 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.
  86. Piedade, GG, Vesper, JJ, Chatzikalfas, AA, Slotty, PP. Cervical and High-Thoracic Dorsal Root Ganglion Stimulation in Chronic Neuropathic Pain. Neuromodulation, 2019 Jan 9.
  87. Rigoard, PP, Basu, SS, Desai, MM, Taylor, RR, Annemans, LL, Tan, YY, Johnson, MM, Van den Abeele, CC, North, RR. Multicolumn Spinal Cord Stimulation for Predominant Back Pain in Failed Back Surgery Syndrome Patients: A Multicenter Randomized Controlled Trial. Pain, 2019 Feb 6.
  88. Schu S, Gulve A, ElDabe S, et al. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Pain Pract. Apr 2015; 15(4):293-299.
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  90. Simpson EL, Duenas A, Holmes MW, et al. Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin:  systematic review and economic evaluation. Health Technology Assessment 2009; Vol. 13, No. 17: iii, ix-x, 1-154.
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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.

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.