|MP 7.01.25||Spinal Cord Stimulation|
|Original Policy Date
|Last Review Status/Date
Reviewed with literature search/1:2015
|Return to Medical Policy Index|
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract. Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage. Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.
SCS 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 4 to 8 electrodes, with 8 electrodes more commonly used for complex pain patterns, such as bilateral pain or pain extending from the limbs to the trunk. There are 2 basic types of power source. In one type, the power source (battery) can be surgically implanted. In 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.
SCS has been used in a wide variety of chronic refractory pain conditions, including pain associated with cancer, failed back pain syndromes, arachnoiditis, and CRPS (ie, 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. 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.
The patient’s pain distribution pattern dictates at what level in the spinal cord the stimulation lead is placed. The pain pattern may influence the type of device used; for example, a lead with 8 electrodes may be selected for those with complex pain patterns or bilateral pain. 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 SCS may require extensive programming of the neurostimulators to identify the optimal electrode combinations and stimulation channels. Computer-controlled programs are often used to assist the physician in studying the millions of programming options when complex systems are used.
A number of total implanted spinal cord stimulators have received FDA premarket approval (PMA). The Cordis programmable neurostimulator from Cordis Corp. was approved in 1981, and the Itrel® manufactured by Medtronic was approved in 1984. In April 2004, Advanced Bionics received PMA for its Precision Spinal Cord Stimulator as an aid in management of chronic, intractable trunk and limb pain. All are fully implanted devices. FDA product code: LGW.
Spinal cord stimulation may be considered medically necessary for the treatment of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies, when performed according to policy guidelines.
Spinal cord stimulation is considered investigational in all other situations including but not limited to treatment of critical limb ischemia to forestall amputation and treatment of refractory angina pectoris, heart failure, and cancer-related pain.
Patient selection focuses on determining whether or not the patient is refractory to other types of treatment. The following considerations may apply.
- The treatment is used only as a last resort; other treatment modalities (pharmacological, surgical, psychological, or physical, if applicable) have been tried and failed or are judged to be unsuitable or contraindicated;
- Pain is neuropathic in nature; i.e., resulting from actual damage to the peripheral nerves. Common indications include, but are not limited to failed back syndrome, complex regional pain syndrome (i.e., reflex sympathetic dystrophy), arachnoiditis, radiculopathies, phantom limb/stump pain, peripheral neuropathy. Spinal cord stimulation is generally not effective in treating nociceptive pain (resulting from irritation, not damage to the nerves) and central deafferentation pain (related to CNS damage from a stroke or spinal cord injury).
- No serious untreated drug habituation exists;
- Demonstration of at least 50% pain relief with a temporarily implanted electrode precedes permanent implantation;
- All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment, and follow-up of the patient are available.
BlueCard/National Account Issues
Patients with chronic refractory pain may be managed through case management programs.
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved devices may be assessed on the basis of their medical necessity.
This policy was originally created in 1996 and was updated regularly with searches of the MEDLINE database. Most recently, the literature was reviewed through December 15, 2014. Following is a summary of the key literature to date:
Chronic trunk or limb pain
In 2009, a systematic review of randomized controlled trials (RCTs) and observational studies of spinal cord stimulation (SCS) in postlumbar surgery syndrome was undertaken by Frey et al.(1) Primary outcome measures were short term (≤1 year) and long-term (>1 year) pain relief, and secondary measures were improvement in functional status, psychologic status, return to work, and reduction in opioid intake. The authors caution that the paucity and heterogeneity of the literature are limitations of the review. Using U.S Preventive Services Task Force quality ratings, the authors found Level II-1 evidence (from well-designed controlled trials without randomization) or II-2 evidence (from well-designed cohort or case-control analytic studies, preferably from more than 1 center or research group) for clinical use of the treatment on a long term-basis.
Also in 2009, Simpson et al performed a systematic review of the literature to obtain clinical and cost-effectiveness data for SCS in adults with chronic neuropathic or ischemic pain with inadequate response to medical or surgical treatment other than SCS.2 Trials for failed back surgery syndrome and complex regional pain syndrome (CRPS) type I suggested that SCS was more effective than conventional medical management (CMM) or reoperation in reducing pain. The authors concluded:
“evidence from CLI [critical limb ischemia] trials suggests that SCS was more effective than CMM in reducing the use of analgesics up to 6 months, but not at 18 months. Although there was significant pain relief achieved, there was no significant difference between groups in terms of pain relief, for SCS versus CMM or analgesics treatment. SCS had similar limb survival rates to CMM, or analgesics treatment, or prostaglandin E1. SCS and CMM were similarly effective in improving HRQoL [healthrelated quality of life].”
Representative RCTs on SCS for treating pain follow.
A multicenter randomized trial published in 2007 by Kumar et al (PROCESS study) compared SCS (plus conventional medical management) with medical management alone in 100 patients with failed back surgery syndrome.3 Leg pain relief (>50%) at 6 months was observed in 24 (48%) SCS-treated patients and in 4 (9%) controls, with an average leg pain visual analog scale (VAS) score of 40 in the SCS group and 67 in the conventional management control group. Between 6 and 12 months, 5 (10%) patients in the SCS group and 32 (73%) patients in the control group crossed over to the other condition. Of the 84 patients who were implanted with a stimulator over the 12 months of the study, 27 (32%) experienced device-related complications.
In 2008, Kemler et al reported 5-year outcomes from a randomized trial of 54 patients with CRPS.(4) Twenty-four of the 36 patients assigned to SCS and physical therapy were implanted with a permanent stimulator after successful test stimulation; 18 patients were assigned to physical therapy alone. Five-year follow-up showed a 2.5-cm change in VAS pain score in the SCS group (n=20) and a 1.0-cm change for
the control group (n=13). Pain relief at 5 years was not significantly different between the groups; 19 (95%) patients reported that for the same result, they would undergo the treatment again. Ten (42%) patients underwent reoperation due to complications.
Two European RCTs published in 2014 evaluated SCS as a treatment of painful diabetic neuropathy of the lower extremities. Both enrolled patients from pain clinics, included patients refractive to medical therapy, and compared best medical treatment with and without SCS. Slangen et al included 36 patients, 22 were randomly assigned to SCS and 14 to continued best medical therapy.(5) Patients in the SCS group underwent trial stimulation for 2 weeks, and 16 positive responders underwent implantation of an SCS device. Treatment success was predefined as at least a 50% reduction in pain intensity for 4 days or a score of at least 6 on a 7 point Likert scale (1 = very much worse and 7 = very much improved). In an intention-to-treat analysis conducted after 6 months of treatment, 59% in the SCS group and 7% in the
usual care group were considered treatment successes (p<0.01). Seven patients in the SCS group and none in the usual care group reduced their use of pain medication. Two patients in the SCS group experienced a serious adverse event; 1 infection and 1 postdural puncture headache in the test stimulation phase.
De Vos et al randomized 40 patients to SCS and 20 to best medical therapy.(6) After a maximum of 7 days of trial stimulation, 37 patients in the SCS group underwent device implantation. Fifty-four patients completed the 6-month follow-up; analysis was intention to treat. The primary outcome, more than 50% pain relief at 6 months, was achieved by 25 of 40 (62.5%) patients in the SCS group and 1 of 20 (5%) in
the control group (p not reported). Mean scores on a 100-point VAS decreased from 73 to 31 in the SCS group and remained at 67 in the control group. Both of the studies had dramatic findings in favor of SCS; however, both had only 6 months of follow-up.
The evidence on SCS for treatment of chronic limb or trunk pain consists of a number of small RCTs that include patients with refractory pain due to conditions such as failed back surgery and CRPS. These studies are heterogenous in terms of patient populations and outcomes but generally report an improvement in pain and a reduction in requirement for medications. Because these patients have few other options, this evidence suggests that SCS is a reasonable treatment option.
Critical Limb Ischemia
Critical limb ischemia is described as pain at rest or the presence of ischemic limb lesions. If patients are not suitable candidates for limb revascularization (typically due to insufficient distal runoff), it is estimated that amputation will be required in a substantial number of these patients. SCS has been investigated in this subset of patients as a technique to relieve pain and decrease the incidence of amputation.
A systematic review from the Cochrane group on the use of SCS in peripheral vascular diseases was updated in 2013.(7) The review included RCTs and non-RCTs evaluating the efficacy of SCS in adults with nonreconstructable chronic critical leg ischemia. Six trials were identified; all were conducted in Europe and 5 were single-country studies. SCS was compared with other nonsurgical interventions. One study was nonrandomized and none were blinded.
In a pooled analysis of data from all 6 studies, there was a significantly higher rate of limb survival in the SCS group compared with the control group at 12 months (pooled risk difference [RD], -0.11; 95% confidence interval [CI], -0.20 to -0.02). The 11% difference in the rate of limb salvage means that 9 patients would need to be treated to prevent 1 additional amputation (number needed to treat, 9; 95% CI,
5 to 50). However, when the nonrandomized study was excluded, the difference in the rate of amputation no longer differed significantly between groups (RD, -0.09; 95% CI, -0.19 to 0.01). The SCS patients required significantly fewer analgesics, and more patients reached Fontaine stage II than in the control group. There was no difference in ulcer healing (but only 2 studies were included in this analysis). In the 6 studies, 31 of 210 patients (15%) had a change in stimulation requiring intervention, 8 (4%) experienced end of battery life, and there were 6 (3%) infections requiring device removal.
Previously, in 2009, Klomp et al published a meta-analysis that was limited to RCTs on SCS in patients with critical limb ischemia.(8) The same 5 RCTs identified in the Cochrane review, previously described, were included. The authors did not find a statistically significant difference in the rate of amputation in the treatment and control groups. There was a relative risk of amputation of 0.79 and a risk difference of -0.07 (p=0.15). The authors also conducted additional analyses of data from their 1999 RCT to identify factors associated with a better or worse prognosis. They found that patients with ischemic skin lesions had a higher risk of amputation compared with patients with other risk factors. There were no significant interactions between this or any other prognostic factor. The analyses did not identify any subgroup of patients who might benefit from SCS.
A number of relatively small RCTs of SCS versus usual care have been completed on patients with critical limb ischemia. In pooled analyses of these RCTs, SCS did not result in a significantly lower rate of amputation. This evidence is not sufficient to conclude that SCS improves outcomes for patients with critical limb ischemia.
Refractory Angina Pectoris
SCS has been used for treatment of refractory angina in Europe for 20 years, and much of the literature on SCS comes from European centers. Several systematic reviews have been published. In 2009, Taylor et al included 7 RCTs in a systematic review of SCS in the treatment of refractory angina.(9) The authors noted that trials were small and varied considerably in quality. They concluded that “compared to a ‘no
stimulation’ control, there was some evidence of improvement in all outcomes following SCS implantation with significant gains observed in pooled exercise capacity and health related quality of life,” however, “further high quality RCT and cost effectiveness evidence is needed before SCS can be accepted as a routine treatment for refractory angina.”
In 2008, a systematic review of the literature based on the Swedish Council on Technology Assessment in Health Care report on SCS in severe angina pectoris was published.(10) Seven controlled studies (5 randomized), 2 follow-up reports, and a preliminary report, as well as 2 nonrandomized studies determined to be of medium-to-high quality were included in the review. The largest RCT included 104 subjects and compared SCS and coronary artery bypass graft (CABG) in patients accepted for CABG and who were considered to have only symptomatic indication (ie, no prognostic benefit) for CABG, according to the American College of Cardiology/American Heart Association guidelines, to run an increased risk of surgical complications, and to be unsuitable for percutaneous transluminal coronary angioplasty. Between-group differences on nitrate consumption, anginal attack frequency, and self-estimated treatment effect were not statistically significant at the 6-month follow-up.(11) At the 5-year followup, significantly fewer patients in the CABG group were taking long-acting nitrates, and between-group differences on quality of life and mortality were not significant.(12) Other studies included in the Swedish systematic review include one by McNab et al from 2006 that compared SCS and percutaneous myocardial laser revascularization (PMR) in a study with 68 subjects.(13) (Note: PMR is currently considered investigational through Medical Policy Reference Manual review.) Thirty subjects in each group completed a 12-month follow-up, and differences on mean total exercise time and mean time to angina were not significant. Eleven in the SCS group and 10 in the PMR group had no angina during exercise. The remaining RCTs included in the systematic review included 25 or fewer subjects.
Several RCTs were published after the systematic review but had limitations, such as small sample size and short follow-up. In 2012, Zipes et al published an industry-sponsored, single-blind, multicenter trial with sites in the United States and Canada.(14) This study, however, was terminated early. The Data and Safety Monitoring Board recommended that the study be terminated for futility after the interim analysis. A total of 118 patients with severe angina, despite maximal medical treatment were enrolled in the study. Of these, 71 patients (60%) underwent SCS implantation with the Intrel III neurostimulator (Medtronic). The remaining 47 patients were found not to meet eligibility criteria postenrollment or there were other issues, eg, withdrawal of consent. The investigators had originally been planning to randomize up to 310 patients, but enrollment was slow. Implantation was successful in 68 patients; this group was randomized to high-stimulation (n=32) or a low-stimulation control (n=36). The low-stimulation control was designed so that patients would feel paresthesia, but the effect of stimulation would be subtherapeutic. The primary outcome was a composite variable of major adverse cardiac events (MACE), which included death from any cause, acute myocardial infarction, or revascularization through 6 months. Fifty-eight of 68 patients (85%) contributed data to the 6-month analysis; analysis was by intention to treat. The proportion of patients experiencing MACE at 6 months did not differ significantly between groups (12.6% in the highstimulation group and 14.6% in the low-stimulation group; p=0.81). The sample size of this study was
small, and it may have been underpowered for clinically meaningful differences.
A small 2011 RCT from Italy randomly assigned 25 patients to 1 of 3 treatment groups: SCS with standard levels of stimulation (n=10), SCS with low-level stimulation (75% to 80% of the sensory threshold) (n=7), or very low-intensity SCS (n=8).(15) Thus, patients in groups 2 and 3 were unable to feel sensation during stimulation. After a protocol adjustment at 1 month, patients in the very low-intensity group were re-randomized to one of the other groups after which there were 13 patients in the standard stimulation group and 12 patients in the low-level stimulation group. At the 3-month follow-up (2 months after re-randomization), there were statistically significant between-group differences in 1 of 12 outcome variables. There were a median of 22 angina episodes in the standard stimulation group and 10 in the low-level stimulation group (p=0.002). Nonsignificant variables included use of nitroglycerin, quality of life (VAS), Canadian Cardiovascular Society angina class, exercise-induced angina, and 5 subscales of the Seattle angina questionnaire.
Numerous small RCTs have evaluated SCS as a treatment for refractory angina. While some studies have reported benefit, most have not. In 2 of the larger, more recent RCTs that enrolled more than 100 patients, there was no benefit on the primary outcomes. Overall, this evidence is mixed and not sufficient to allow conclusions on whether health outcomes are improved.
Findings of a small pilot crossover RCT evaluating SCS for heart failure were published in 2014 by Torre-Amione et al.(16) Eligibility included symptomatic heart failure despite optimal medical therapy, left ventricular ejection fraction less than 30%, hospitalization or need for intravenous inotropic support in the past year, and ability to walk less than 450 meters on a 6-minute walk test. All patients had an implanted
heart device. Nine patients underwent SCS implantation and received 3 months of active treatment and 3 months of inactive treatment (off position), in random order. There was a 1-month washout period between treatments. The primary outcome was a composite of death, hospitalization for worsening heart failure, and symptomatic bradyarrhythmia or tachyarrhythmia requiring high-voltage therapy. Four patients
experienced at least 1 of the events in the composite end point. The event occurred in 2 patients while the device was turned on and 2 while it was turned off. One patient died about 2 months after implantation while the device was turned off. The SCS devices did not interfere with the functioning of implantable cardioverter defibrillators. Additional RCTs with larger sample sizes and longer follow-up are needed to draw conclusions on the safety and effectiveness of the therapy for this indication.
In 2013, a Cochrane review by Lihua et al was published on SCS for treatment of cancer-related pain in adults.(17) The authors did not identify any RCTs evaluating the efficacy of SCS in patients with cancerrelated pain. Four case series using a before-after design with a total of 92 patients were identified. In the absence of controlled studies, the efficacy of SCS for treating cancer-related pain cannot be determined.
Potential Adverse Effects
Whereas RCTs are useful for evaluating efficacy, observational studies can provide data on the likelihood of potential complications. In 2010, Mekhail et al published a retrospective review of 707 patients treated with SCS between 2000 and 2005.(18) The patients’ diagnoses included CRPS (n=345 [49%]), failed back surgery syndrome (n=235 [33%]), peripheral vascular disease (n=20 [3%]), visceral pain in the chest, abdomen, or pelvis (n=37 [5%]), and peripheral neuropathy (n=70 [10%]). There was a mean follow-up of 3 years (range, 3 months to 7 years). A total of 527 of the 707 (36%) eventually underwent permanent implantation of an SCS device. Hardware-related complications included lead migration in 119 of 527 (23%) cases, lead connection failure in 50 (9.5%) cases, and lead break in 33 (6%) cases. Revisions or
replacements were done to correct the hardware problems. The authors noted that rates of hardware failure have decreased in recent years due to advances in SCS technology. Documented infection occurred in 32 of 527 (6%) patients with implants; there were 22 cases of deep infection, and 18 patients had documented abscesses. There was not a significant difference in the infection rate by diagnosis. All cases of infection were managed by device removal.
In 2012, Lanza et al reviewed observational studies on SCS in patients with refractory angina pectoris.(19) The authors identified 16 studies with a total of 1204 patients (although they noted that patients may have been included in more than 1 report). The most frequently reported complications were lead issues, ie, electrode dislodgement or fracture requiring repositioning, or internal programmable generator (IPG)
failure during substitution. Lead issues were reported by 10 studies with a total of 450 patients. In these studies, 55 cases of lead or IPG failure were reported. No fatalities related to SCS treatment were reported.
Ongoing and Unpublished Clinical Trials
- Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)( NCT01697358)(20): This multicenter, open-label RCT is comparing SCS plus optimal medical management to optimal medical management alone in patients with failed back surgery syndrome who have persistent back and leg pain. The primary study outcome is the proportion of subjects with at least 50% reduction in low back pain intensity at 6 months. Estimated enrollment is 300 patients, and the expected date of study completion is April 2016.
- Refractory Angina Spinal Cord and Usual Care (RASCAL) trial(21): This is a pilot RCT that is comparing SCS plus usual care with usual care alone in patients with refractory angina. The investigators aim to recruit 45 patients. The study is being conducted at 3 centers in the United Kingdom.
Summary of Evidence
In patients with refractory trunk or limb pain, the available evidence on spinal cord stimulation (SCS) is mixed and limited by heterogeneity. Systematic reviews have found support for the use of SCS to treat refractory trunk or limb pain, and patients who have failed all other treatment modalities have very limited options. Therefore, SCS for chronic refractory pain of the trunk or limbs may be considered medically
necessary when criteria are met. For other potential indications, there is insufficient evidence from controlled trials to conclude that SCS improves the net health outcomes and therefore, SCS is considered investigational.
Practice Guidelines and Position Statements
In 2013, the Neuropathic Pain Special Interest Group of the International Association for the Study of Pain published recommendations on management of neuropathic pain.(22) The interest group issued 2 recommendations on SCS; both were considered weak due to the amount and consistency of the evidence. The recommendations supported the use of SCS for failed back surgery syndrome and for complex regional pain syndrome (CRPS).
In 2012, the Special Interest Group of the Canadian Pain Society published a guideline on interventions for neuropathic pain.(23) The guideline stated that clinicians should consider offering a trial of SCS to patients with failed back syndrome and CRPS who are not surgical candidates and who have failed conservative evidence-based treatments (recommendation based on good evidence with moderate certainty, grade B strength of recommendation). The guideline also stated that clinicians should consider offering a trial of SCS to patients with traumatic neuropathy and brachial plexopathy who are not surgical candidates and have failed conservative evidence-based treatments (recommendation based on fair evidence with moderate certainty, grade C strength of recommendation).
In 2013, the American Society of Interventional Pain Physicians (ASIPP) updated their evidence-based guidelines for interventional techniques in the management of chronic spinal pain.(24) The guidelines included the statement that there is fair evidence in support of SCS in managing patients with failed back surgery syndrome.
In October 2008, the National Institute for Health and Clinical Excellence issued a guideline on spinal cord stimulation for chronic pain of neuropathic or ischemic origin.(25) 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 visual analog scale) 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.
An evidence-based guideline from ASIPP found the evidence for SCS in failed back surgery syndrome and CRPS strong for short-term relief and moderate for long-term relief.(26) Reported complications with SCS ranged from infection, hematoma, nerve damage, lack of appropriate paresthesia coverage, paralysis, nerve injury, and death.
U.S. Preventive Services Task Force Recommendations
The U.S. Preventive Services Task Force has not addressed spinal cord stimulation.
Medicare National Coverage
According to Medicare policy, the implantation of central nervous system stimulators may be covered as therapies for the relief of chronic intractable pain, subject to the following conditions:
- The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain;
- With respect to item a, other treatment modalities (pharmacological, surgical, physical, or psychological therapies) have been tried and did not prove satisfactory, or are judged to be unsuitable or contraindicated for the given patient;
- Patients have undergone careful screening, evaluation, and diagnosis by a multidisciplinary team prior to implantation (such screening must include psychological, as well as physical evaluation);
- All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment training, and follow-up of the patient (including that required to satisfy item c) must be available; and
- Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation.(27)
- Frey ME, Manchikanti L, Benyamin RM, et al. Spinal cord stimulation for patients with failed back surgery syndrome: a systematic review. Pain Physician. Mar-Apr 2009;12(2):379-397. PMID 19305486
- 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 Technol Assess. Mar 2009;13(17):iii, ix-x, 1-154. PMID 19331797
- 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):179-188. PMID 17845835
- 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):292-298. PMID 18240925
- 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. PMID 25216508
- de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: A multicentre randomized clinical trial. Pain. Aug 29 2014. PMID 25180016
- Ubbink DT, Vermeulen H. Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia. Cochrane Database Syst Rev. 2013;2:CD004001. PMID 23450547
- 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-Jun 2009;23(3):355-363. PMID 19128928
- Taylor RS, De Vries J, Buchser E, et al. Spinal cord stimulation in the treatment of refractory angina: systematic review and meta-analysis of randomised controlled trials. BMC Cardiovasc Disord. 2009;9:13. PMID 19320999
- Borjesson M, Andrell P, Lundberg D, et al. Spinal cord stimulation in severe angina pectoris--a systematic review based on the Swedish Council on Technology assessment in health care report on long-standing pain. Pain. Dec 2008;140(3):501-508. PMID 19004553
- Mannheimer C, Eliasson T, Augustinsson LE, et al. Electrical stimulation versus coronary artery bypass surgery in severe angina pectoris: the ESBY study. Circulation. Mar 31 1998;97(12):1157-1163. PMID 9537342
- 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. Dec 2002;23(24):1938-1945. PMID 12473256
- 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. May 2006;27(9):1048-1053. PMID 16554313
- Zipes DP, Svorkdal N, Berman D, et al. Spinal Cord Stimulation Therapy for Patients With Refractory Angina Who Are Not Candidates for Revascularization. Neuromodulation. Apr 11 2012. PMID 22494013
- 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. Jan 2011;152(1):45-52. PMID 21084162
- Torre-Amione G, Alo K, Estep JD, et al. Spinal cord stimulation is safe and feasible in patients with advanced heart failure: early clinical experience. Eur J Heart Fail. Jul 2014;16(7):788-795. PMID 24961194
- Lihua P, Su M, Zejun Z, et al. Spinal cord stimulation for cancer-related pain in adults. Cochrane Database Syst Rev. 2013;2:CD009389. PMID 23450600
- Mekhail NA, Mathews M, Nageeb F, et al. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. Mar-Apr 2011;11(2):148-153. PMID 21371254
- Lanza GA, Barone L, Di Monaco A. Effect of spinal cord stimulation in patients with refractory angina: evidence from observational studies. Neuromodulation. 2012 Nov-Dec;15(6):542-9. PMID 22364309
- Sponsored by MedtronicNeuro. Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)(NCT01697358). www.clinicaltrials.gov. Accessed November, 2014.
- Eldabe S, Raphael J, Thomson S, et al. The effectiveness and cost-effectiveness of spinal cord stimulation for refractory angina (RASCAL study): study protocol for a pilot randomized controlled trial. Trials. 2013;14:57. PMID 23433492
- Dworkin RH, O'Connor AB, Kent J, et al. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain. Nov 2013;154(11):2249-2261. PMID 23748119
- 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. May-Jun 2012;17(3):150-158. PMID 22606679
- 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. Apr 2013;16(2 Suppl):S49-283. PMID 23615883
- National Institute for Health and Clinical Excellence (NICE). Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin. NICE Technology Appraisal Guidance 159. October 2008. http://guidance.nice.org.uk/TA159. Accessed November, 2014.
- Boswell MV, Trescot AM, Datta S, et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. Jan 2007;10(1):7-111. PMID 17256025
- Centers for Medicare and Medicaid Services (CMS). National Coverage Determination for Electrical Nerve Stimulators (160.7). http://www.cms.gov. Accessed November, 2014.
|CPT||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|
|63663||Revision including replacement, when performed, of spinal neurostimulator electrode percutaneous array(s), including fluoroscopy, when performed|
|63664||Revision including replacement, when performed, of spinal neurostimulator electrode plate/paddle(s) placed via laminotomy or laminectomy, including fluoroscopy, when performed|
|63685||Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling|
|63688||Revision or removal of implanted spinal neurostimulator pulse generator or receiver|
|95970, 95971, 95972, 95973||Neurostimulator programming and analysis code range|
|ICD-9 Procedure||03.93||Insertion or replacement of spinal neurostimulator|
|03.94||Removal of spinal neurostimulator lead(s)|
|86.05||Incision with removal of foreign body or device from skin and subcutaneous tissue (used to report removal of a neurostimulator pulse generator)|
|86.94||Insertion or replacement of single array neurostimulator pulse generator, not specified as rechargeable|
|86.95||Insertion or replacement of dual array neurostimulator pulse generator, not specified as rechargeable|
|86.97||Insertion or replacement of single array rechargeable neurostimulator pulse generator (new code effective 10/1/05)|
|86.98||Insertion or replacement of dual array rechargeable neurostimulator pulse generation (new code effective 10/1/05)|
|ICD-9 Diagnosis||See “Pain” in ICD-9 diagnosis index|
|HCPCS||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, nonrechargeable, includes extension|
|L8687||Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension|
|L8688||Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension|
|ICD-10-CM (effective 10/1/15)||This list is a representative list of severe and chronic pain of the trunk and limbs diagnosis codes.|
|G56.40 -G56.42||Causalgia of upper limb code range|
|G57.70 -G57.72||Causalgia of lower limb code range|
|G89.21 -G89.8||Chronic pain, not elsewhere classified, code range|
|G89.4||Chronic pain syndrome|
|G90.50 -G90.59||Complex regional pain syndrome I (CRPS I), code range|
|M25.50 -M25.579||Pain in joint, code range|
|M54.10 -M54.18||Radiculopathy, code range|
|M54.30 -M54.32||Sciatica, code range|
|M54.40 -M54.42||Lumbago with sciatica, code range|
|M54.5||Low back pain|
|M54.6||Pain in thoracic spine|
|M54.81, M54.89||Other dorsalgia codes|
|M79.60 -M79.676||Pain in limb, hand, foot, fingers and toes code range|
|ICD-10-PCS (effective 10/1/15)||ICD-10-PCS codes are only used for inpatient services.|
|Surgical, central nervous system, insertion, spinal canal, neurostimulator lead, code by approach|
|00HV0MZ, 00HV3MZ, 00HV4MZ||Surgical, central nervous system, insertion, spinal cord, neurostimulator lead, code by approach|
|00WU0MZ, 00WU3MZ, 00WU4MZ||Surgical, central nervous system, removal, spinal canal, neurostimulator lead, code by approach|
|00PV0MZ, 00PV3MZ, 00PV4MZ||Surgical, central nervous system, removal, spinal cord, neurostimulator lead, code by approach|
|00WU0MZ, 00WU3MZ, 00WU4MZ||Surgical, central nervous system, revision, spinal canal, neurostimulator lead, code by approach|
|00WV0MZ, 00WV3MZ, 00WV4MZ||Surgical, central nervous system, revision, spinal cord, neurostimulator lead, code by approach|
|0JH60M6, 0JH60M7, 0JH60M8, 0JH60M9, 0JH63M6, 0JH63M7, 0JH63M8, 0JH63M9, 0JH70M6, 0JH70M7, 0JH70M8, 0JH70M9, 0JH73M6, 0JH73M7, 0JH73M8, 0JH73M9, 0JH80M6, 0JH80M7, 0JH80M8, 0JH80M9, 0JH83M6, 0JH83M7, 0JH83M8, 0JH83M9||Surgical, subcutaneous tissue and fascia, insertion, stimulator generator, code by body part, approach, number of arrays and whether rechargeable or not|
|0JPT0MZ, 0JPT3MZ||Surgical, subcutaneous tissue and fascia, removal, subcutaneous tissue and fascia, trunk, stimulator generator, code by approach (there aren’t ICD-10-PCS codes for removal of stimulator generator from other body parts)|
|Type of Service||Surgical|
|Place of Service||Inpatient/Outpatient|
Electrical Nerve Stimulation, Spinal
Spinal Cord Stimulation
Stimulation, Electrical, Spinal Cord
|03/31/96||Add to Surgery section||New policy|
|04/01/98||Replace policy||Policy cross-referenced to No. 7.01.63|
|07/10/98||Replace policy||Policy updated and revised|
|11/15/98||Coding update||1999 CPT coding release|
|04/29/03||Replace policy||Policy updated; new policy statement added, stating that spinal cord stimulation is investigational as a treatment of critical limb ischemia|
|11/9/04||Replace policy||Policy updated; no change to policy statement. Coding updated|
|08/17/05||Replace policy||Policy updated with literature search and coding updated; no change to policy statement|
|12/14/05||Replace policy – coding update only||Coding updated|
|12/12/06||Replace policy||Policy updated with literature search; no change to policy statement; reference numbers 7 – 9 added|
|03/13/08||Replace policy||Policy updated with literature search; references 10 – 13 added; no change to policy statements|
|01/08/09||Policy updated with literature search; references 14–25 added. Use in refractory angina added as investigational indication.|
|01/14/10||Replace policy||Policy updated with literature search; reference numbers 26-29 added; no change to policy statements|
|01/13/11||Replace policy||Policy updated with literature search. Rationale extensively reqritten; references numbers 15 and 16 added, other references reordered or removed. No change to policy statements.|
|1/12/12||Replace policy||Policy updated with literature search. Reference numbers 16, 17 and 18 added, other references reordered or removed. No change to policy statements|
|1/10/13||Replace policy||Policy updated with literature search. Reference numbers 14, 17, 19 and 20 added; other references reordered or removed. No change to policy statements.|
|1/09/14||Replace policy||Policy updated with literature search through December 5, 2013. References 5, 14, 18-20, and 22 added. Investigational statement modified to state all other situations, with examples. Cancer-related pain added to investigational statement.|
|1/15/15||Replace policy||Policy updated with literature review through December 15, 2014. References 5-6 and 16 added. Heart failure added to investigational statement, and investigational statement edited for readability.|