Coverage Policy Manual
Policy #: 1997208
Category: Surgery
Initiated: January 1994
Last Review: February 2019
  Spinal Cord Neurostimulation for Treatment of Intractable Pain

Description:
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 either have a power source (battery) that is surgically implanted or else the power source is worn externally and only the radiofrequency receiver is implanted.
 
Spinal cord stimulation (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 two 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.
 
Spinal cord stimulation 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 spinal cord stimulation 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 spinal cord stimulation 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 spinal cord stimulation 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 U.S. Food and Drug Administration (FDA) premarket approval (PMA). The Cordis programmable neurostimulator from Cordis, Corp. was approved in 1981, and the Itrel(R) 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.
 
Coding
If the patient has placement of the temporary electrode, but the trial period indicates the patient will not benefit from the placement of the permanent electrode, the physician should bill CPT 63650 for the percutaneous implantation of neurostimulator electrodes, epidural, only.
 
If the patient has placement of the percutaneous implantation of the neurostimulator electrodes, epidural, for the trial period, and the treatment is effective, then the physician should bill CPT 63650 for the placement of that electrode, and CPT 63685 for the incision and subcutaneous placement of the spinal neurostimulator pulse generator or receiver.
 
If the placement of the electrode is done by laminectomy, then CPT 63655 is billed for the placement and CPT 63685 for the incision and subcutaneous placement of the spinal neurostimulator pulse generator or receiver.
 

Policy/
Coverage:
Effective February 2019
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Implantation of spinal neurostimulators meets primary coverage criteria for effectiveness for control of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies, when all of the following criteria is met:
    • The implantation of the stimulator is used only as a last resort for patients with chronic intractable pain;  
    • 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. Psychological screening is necessary for coverage of trial stimulation and must not be performed by the provider implanting the neurostimulation.);  
    • 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 the requirement above), must be available; and  
    • Demonstration of at least 50% pain relief with a temporarily implanted electrode (screening trial lasting 3-8 days) precedes permanent implantation;
 
Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.
 
Implantation of spinal neurostimulators for patients with documented metastatic malignant disease, who have a life expectancy of at least six months, meets member benefit certificate primary coverage criteria when above criteria are met, with the exception of psychological testing which would not be required.
 
Implantation of spinal neurostimulators meets member benefit certificate primary coverage criteria for patients with severe angina when the risks of surgery are deemed too high and standard medical therapy options have been exhausted and above criteria are met, with the exception of psychological testing which would not be required.
 
If the patient has had the neurostimulator in place, and the patient is experiencing satisfactory reduction in pain, and the patient requires revision or removal of the spinal neurostimulator electrodes and/or revision or removal of the implanted spinal neurostimulator pulse generator or receiver, the patient does not have to undergo a trial period or any further psychological testing.
 
“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.
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.
 
Implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Wireless injectable dorsal root ganglion neurostimulation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria Wireless injectable dorsal root ganglion is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage
 
Effective Prior to February 2019
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Implantation of spinal neurostimulators meets primary coverage criteria for effectiveness for control of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies, when all of the following criteria is met:
    • The implantation of the stimulator is used only as a last resort for patients with chronic intractable pain;
    • 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. Psychological screening is necessary for coverage of trial stimulation and must not be performed by the provider implanting the neurostimulation.);
    • 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 the requirement above), must be available; and
    • Demonstration of at least 50% pain relief with a temporarily implanted electrode (screening trial lasting 3-8 days) precedes permanent implantation;
 
Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.
 
Implantation of spinal neurostimulators for patients with documented metastatic malignant disease, who have a life expectancy of at least six months, meets member benefit certificate primary coverage criteria when above criteria are met, with the exception of psychological testing which would not be required.
 
Implantation of spinal neurostimulators meets member benefit certificate primary coverage criteria for patients with severe angina when the risks of surgery are deemed too high and standard medical therapy options have been exhausted and above criteria are met, with the exception of psychological testing which would not be required.
 
If the patient has had the neurostimulator in place, and the patient is experiencing satisfactory reduction in pain, and the patient requires revision or removal of the spinal neurostimulator electrodes and/or revision or removal of the implanted spinal neurostimulator pulse generator or receiver, the patient does not have to undergo a trial period or any further psychological testing.
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.
 
Implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Wireless injectable dorsal root ganglion neurostimulation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria Wireless injectable dorsal root ganglion is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage
 
Effective  May 2017 through January 2018
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Implantation of spinal neurostimulators meets primary coverage criteria for effectiveness for control of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies, when all of the following criteria is met:
  • The implantation of the stimulator is used only as a last resort for patients with chronic intractable pain;
  • 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. Psychological screening is necessary for coverage of trial stimulation.);
  • 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 the requirement above), must be available; and
  • Demonstration of at least 50% pain relief with a temporarily implanted electrode (screening trial lasting 3-8 days) precedes permanent implantation;
 
Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.
 
Implantation of spinal neurostimulators for patients with documented metastatic malignant disease, who have a life expectancy of at least six months, meets member benefit certificate primary coverage criteria when above criteria are met, with the exception of psychological testing which would not be required.
 
Implantation of spinal neurostimulators meets member benefit certificate primary coverage criteria for patients with severe angina when the risks of surgery are deemed too high and standard medical therapy options have been exhausted and above criteria are met, with the exception of psychological testing which would not be required.
 
If the patient has had the neurostimulator in place, and the patient is experiencing satisfactory reduction in pain, and the patient requires revision or removal of the spinal neurostimulator electrodes and/or revision or removal of the implanted spinal neurostimulator pulse generator or receiver, the patient does not have to undergo a trial period or any further psychological testing.
 
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.
 
Implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above is considered not medically necessary. Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Wireless injectable dorsal root ganglion neurostimulation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria Wireless injectable dorsal root ganglion is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to May 2017
Implantation of spinal neurostimulators meets primary coverage criteria for effectiveness for control of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies, when all of the following criteria is met:
 
        • The implantation of the stimulator is used only as a last resort for patients with chronic intractable pain;
        • 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 multi-disciplinary team prior to implantation.  (Such screening must include psychological, as well as physical evaluation.  Psychological screening is necessary for coverage of  trial stimulation.);
        • 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 the requirement above), must be available; and
        • Demonstration of at least 50% pain relief with a temporarily implanted electrode (screening trial lasting 3-8 days) precedes permanent implantation;
 
Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.
 
Implantation of spinal neurostimulators for patients with documented metastatic malignant disease, who have a life expectancy of at least six months, meets member benefit certificate primary coverage criteria when above criteria are met, with the exception of psychological testing which would not be required.
 
Implantation of spinal neurostimulators meets member benefit certificate primary coverage criteria for patients with severe angina when the risks of surgery are deemed too high and standard medical therapy options have been exhausted and above criteria are met, with the exception of psychological testing which would not be required.
 
If the patient has had the neurostimulator in place, and the patient is experiencing satisfactory reduction in pain, and the patient requires revision or removal of the spinal neurostimulator electrodes and/or revision or removal of the implanted spinal neurostimulator pulse generator or receiver, the patient does not have to undergo a trial period or any further psychological testing.
 
Implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  
 
For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above is considered not medically necessary.  Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective February 2012 to February 2013
Implantation of spinal neurostimulators meets primary coverage criteria for effectiveness for control of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies, when all of the following criteria is met:
 
    • The implantation of the stimulator is used only as a last resort for patients with chronic intractable pain;
    • 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 multi-disciplinary team prior to implantation.  (Such screening must include psychological, as well as physical evaluation.  Psychological screening is necessary for coverage of  trial stimulation.);
    • 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 the requirement above), must be available; and
    • Demonstration of pain relief with a temporary implanted electrode precedes permanent implantation.  (Demonstration of pain relief over at least a three day interval between the placement of the temporary electrode and the permanent electrode is required.)  Once treatment effectiveness is established (at least 59% reduction in pain), the electrodes and radio-receiver/transducer are permanently implanted.
 
Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.
 
Implantation of spinal neurostimulators for patients with documented metastatic malignant disease, who have a life expectancy of at least six months, meets member benefit certificate primary coverage criteria when above criteria are met, with the exception of psychological testing which would not be required.
 
Implantation of spinal neurostimulators meets member benefit certificate primary coverage criteria for patients with severe angina when the risks of surgery are deemed too high and standard medical therapy options have been exhausted and above criteria are met, with the exception of psychological testing which would not be required.
 
If the patient has had the neurostimulator in place, and the patient is experiencing satisfactory reduction in pain, and the patient requires revision or removal of the spinal neurostimulator electrodes and/or revision or removal of the implanted spinal neurostimulator pulse generator or receiver, the patient does not have to undergo a trial period or any further psychological testing.
 
Implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of intractable pain in any circumstance not noted above is considered not medically necessary.  Services that are not medically necessary are specific contract exclusions in most member benefit certificates of coverage.
 
Implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness. For members with contracts without primary coverage criteria, implantation of spinal cord neurostimulators for the treatment of critical limb ischemia as a technique to forestall amputation is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to February 2012
Implantation of spinal neurostimulators meets primary coverage criteria for effectiveness and is covered for control of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies.  
 
Implantation of dorsal column stimulators or services and supplies related to such implantation is not covered unless:
    • The implantation of the stimulator is used only as a last resort for patients with chronic intractable pain;
    • 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 multi-disciplinary team prior to implantation.  (Such screening must include psychological, as well as physical evaluation.  Psychological screening is necessary for coverage of  trial stimulation.);
    • 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 the requirement above), must be available; and
    • Demonstration of pain relief with a temporary implanted electrode precedes permanent implantation.  (Demonstration of pain relief over at least a three day interval between the placement of the temporary electrode and the permanent electrode is required.)  Once treatment effectiveness is established (at least 59% reduction in pain), the electrodes and radio-receiver/transducer are permanently implanted.
 
Psychological testing that demonstrates that the patient is not a suitable candidate for the procedure will exclude coverage for that patient.
 
Implantation of spinal neurostimulators for patients with documented metastatic malignant disease, who have a life expectancy of at least six months, is covered when above criteria are met, with the exception of psychological testing which would not be required.
 
Implantation of spinal neurostimulators is covered for patients with severe angina when the risks of surgery are deemed too high and standard medical therapy options have been exhausted and above criteria are met, with the exception of psychological testing which would not be required.
 
If the patient has had the neurostimulator in place, and the patient is experiencing satisfactory reduction in pain, and the patient requires revision or removal of the spinal neurostimulator electrodes and/or revision or removal of the implanted spinal neurostimulator pulse generator or receiver, the patient does not have to undergo a trial period or any further psychological testing.
 
If the patient has placement of the temporary electrode, but the trial period indicates the patient will not benefit from the placement of the permanent electrode, the physician should bill CPT 63650 for the percutaneous implantation of neurostimulator electrodes, epidural, only.
 
If the patient has placement of the percutaneous implantation of the neurostimulator electrodes, epidural, for the trial period, and the treatment is effective, then the physician should bill CPT 63650 for the placement of that electrode, and CPT 63685 for the incision and subcutaneous placement of the spinal neurostimulator pulse generator or receiver.
 
If the placement of the electrode is done by laminectomy, then CPT 63655 is billed for the placement and CPT 63685 for the incision and subcutaneous placement of the spinal neurostimulator pulse generator or receiver.
 
Spinal Cord Neurostimulation for Treatment of Intractable Pain in any circumstance not noted above, is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.  
 
For contracts without primary coverage criteria, Spinal Cord Neurostimulation for Treatment of Intractable Pain in any circumstance not noted above, is considered not medically necessary.  Medically unnecessary  services are an exclusion in the member certificate of coverage.

Rationale:
This policy was originally created in 1994 and has been updated regularly with searches of the MEDLINE database. The most recent literature search was performed for the period November 2010 through November 2011. 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 post-lumbar surgery syndrome was undertaken by Frey et al, 2009. Primary outcome measures were short term (<1 year) and long-term (>1 year) pain relief, and secondary measures were improvement in functional status, psychological 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 one center or research group) for clinical use of the treatment on a long term-basis.
 
Also in 2009, Simpson and colleagues 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 (Simpson, 2009). Trials for failed back surgery syndrome and complex regional pain syndrome 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 ischaemia] 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 (health-related quality of life).”
 
Representative RCTs on SCS for treating pain are described below:
 
A multicenter randomized trial published in 2007 by Kumar and colleagues (the PROCESS study) compared SCS (plus conventional medical management) with medical management alone in 100 patients with failed back surgery syndrome (Kumar, 2007). 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 analogue 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 and colleagues reported 5-year outcomes from a randomized trial of 54 patients with complex regional pain syndrome (CRPS) (Kemler, 2008). 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.
 
Critical limb ischemia
Critical limb ischemia is described as pain at rest or the presence of ischemic limb lesions. If the patient is not a suitable candidate for limb revascularization (typically due to insufficient distal runoff), it is estimated that amputation will be required in 60–80% of these patients within 1 year. SCS has been investigated in this small 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 2005. Included were 6 European studies of generally good quality with a total of 444 patients (Ubbink, 2005).  None of the studies were blinded. At 12 months’ follow-up, limb salvage improved by 11% compared with any form of conservative treatment with a number needed to treat (NNT) of 9. The SCS patients required significantly fewer analgesics, and more patients reached Fontaine stage II than in the conservative group. There was no difference in ulcer healing. The overall risk of complications or additional SCS treatment was 17%, with a number needed to harm (NNH) of 6. The report concludes that there is evidence to favor SCS over standard conservative treatment to improve salvage and clinical situation in patients with critical leg ischemia but that “the benefits of SCS against the possible harm of relatively mild complications and costs must be considered.” Analysis of data and cost calculations from a randomized trial with 120 patients previously published in 1999 by Klomp and colleagues (Klomp, 1999) showed that the difference in amputation rate at 12 months when SCS was provided in addition to best medical care was no longer present at 24 months, and there was no difference in survival rate at 24 months (Klomp, 2006).  
 
In 2009, Klomp and colleagues published a meta-analysis of 5 randomized trials on spinal cord stimulation for prevention of amputations in patients with critical limb ischemia (Klomp, 2009). They found insufficient evidence that SCS is more efficacious than best medical treatment alone. They 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 to 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.
 
Refractory angina pectoris
Spinal cord stimulation 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 recently been published. In 2009, Taylor et al. included 7 RCTs in a systematic review of SCS in the treatment of refractory angina (Taylor, 2009). 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.”
 
The 2009 Simpson et al. systematic review, described above in the section of the Rationale on pain, (Simpson, 2009) summarized the evidence for SCS for refractory angina as follows: “The authors summarized their review of the evidence for SCS for refractory angina as follows: ‘Evidence from angina trials suggested that SCS was more effective than No SCS or Inactive stimulator for nitrate consumption, frequency of angina attacks, exercise duration and time to angina at short term (6–8 weeks). SCS was also more effective than percutaneous myocardial revascularization (PMR) at 3 months, not at 12 months for time to angina. Health-related Quality of Life (HRQoL) was more improved by SCS than No SCS at 6–8 weeks. There was no difference between SCS and Inactive stimulator in terms of pain relief. SCS and CABG [coronary artery bypass graft] had similar results for short-acting nitrates and frequency of angina attacks. There was no difference in effectiveness of SCS and PMR for change in angina class or exercise duration. SCS did not differ from CABG or PMR or Inactive stimulator in terms of HRQoL. The SCS was less effective than CABG in reducing consumption of long-acting nitrates. SCS was less effective than CABG in increasing maximum workload capacity, although the SCS device was switched off during this comparison.’”
 
In 2008, a systematic review of the literature based on the Swedish Council on Technology Assessment in Health Care report on spinal cord stimulation in severe angina pectoris was published (Borjesson, 2008). Seven controlled studies (5 of them randomized), 2 follow-up reports, and a preliminary report, as well as 2 non-randomized 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 (i.e., 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 (Mannheimer, 1998). At the 5-year follow-up, 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 (Ekre, 2002). Other studies included in the Swedish systematic review include one by McNab et al. from 2006, which compared SCS and PMR in a study with 68 subjects (McNab, 2006).  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.
 
In 2008, Bondesson and colleagues published a non-randomized study comparing SCS with enhanced external counterpulsation (EECP) (Bondesson, 2008). A total of 153 patients with refractory angina pectoris were identified, and transcutaneous electrical nerve stimulation (TENS) was used to test tolerance to electrical stimulation (except those contraindicated by unipolar pacemaker). Forty-four patients had total symptom relief and were implanted with SCS. The 79 nonresponders underwent EECP. A control group consisted of 30 patients for whom SCS or EECP were contraindicated or who were unwilling to have either treatment. Outcome measures were Canadian Cardiovascular Society Class (CCS-class) and glyceryl trinitrate (GTN) usage. At 12 months, EECP reduced CCS class from class 3 (marked limitation in activity, angina may occur after walking one block) to class 2 (slight limitation, angina may occur after walking 2 blocks), and 23% of the EECP group improved by 2 CCS classes. SCS reduced angina less, but the reduction was reported to be clinically significant. Of study patients who used GTN (all but 7%), decrease in weekly use was 67% of patients in the EECP group and 76% in the SCS group. A limitation of the study was there was the potential for a placebo effect because patients were not randomly assigned to treatment groups and could not be blinded to the treatment they received.
 
No large randomized trials on SCS for refractory angina pectoris have been published recently (i.e. from 2008 to present). A small 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) (Lanza, 2011). 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). Non-significant variables included use of nitroglycerin, quality of life (VAS), Canadian Cardiovascular Society angina class, exercise-induced angina, and 5 sub-scales of the Seattle angina questionnaire.
 
Potential adverse effects
Whereas RCTs are useful for evaluating efficacy, observational studies can provide data on the likelihood of potential complications. In 2010, Mekhail and colleagues published a retrospective review of 707 patients treated with SCS between 2000 and 2005 (Mekhail, 2011). 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.
 
Ongoing Clinical Trials
Spinal Cord Stimulation With Precision SCS System Versus Reoperation for Failed Back Surgery Syndrome [FBSS] (EVIDENCE trial) (NCT01036529): This is an open-label RCT comparing the effectiveness and cost-effectiveness of spinal cord stimulation to reoperation for treating pain in patients with FBSS. Eligibility includes leg pain for at least 6 months, with or without back pain, following lumbosacral surgery. The primary endpoints are the proportion of participants with at least 50% leg pain relief at 6 and 24 months after enrollment. The study is sponsored by Boston Scientific; it is estimated that the final data collection date will be March 2014.
 
Effect of Spinal Cord Stimulation in Painful Diabetic Polyneuropathy (PDP) (NCT0116299300): This RCT compared SCS treatment to usual care (optimal medication treatment) in patients with painful diabetic polyneuropathy in the lower limbs. Eligibility includes pain for more than 12 months and previous unsuccessful medication treatment. The primary outcome is pain intensity, and secondary endpoints include quality of life and blood glucose control. The study is sponsored by Maastricht University in the Netherlands. The expected study completion date is April 2012.
 
Practice Guidelines and Position Statements
In 2009, the American Society of Interventional Pain Physicians updated their evidence-based guidelines for interventional techniques in the management of chronic spinal pain. The guideline states that, based on Guyatt et al.’s (2006) criteria, the recommendation for spinal cord stimulation is “1B or 1C/strong recommendation for clinical use on a long-term basis” (1B is defined as ‘strong recommendation, moderate quality evidence’ and 1C as ‘strong recommendation, low-quality or very low-quality evidence’).
 
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.
 
An evidence-based guideline from the American Society of Interventional Pain Physicians found the evidence for SCS in failed back surgery syndrome and complex regional pain syndrome strong for short-term relief and moderate for long-term relief (Boswell, 2007). Reported complications with SCS ranged from infection, hematoma, nerve damage, lack of appropriate paresthesia coverage, paralysis, nerve injury, and death.
 
2014 Update
 
A literature search conducted through February 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Critical limb ischemia
 
A systematic review from the Cochrane group on the use of SCS in peripheral vascular diseases was updated in 2013 (Ubbink, 2013). 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 to 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 to 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.(6) The same 5 RCTs identified in the Cochrane review, described above, 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 to 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.
 
Cancer-related pain
 
In 2013, a Cochrane review by Lihua et al was published on SCS for treatment of cancer-related pain in adults (Lihua, 2013). The authors did not identify any RCTs evaluating the efficacy of SCS in patients with cancer-related pain. Four case series using a before-after design with a total of 92 patients were identified. In the absence of controlled studies, the efficacy of SCS for treating cancer-related pain cannot be determined.
 
Ongoing Clinical Trials
 
Spinal Cord Stimulation for Predominant Low Back Pain (PROMISE)( NCT01697358) (MedtronicNeuro, 2013): 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 (Eldabe, 2013): This is a pilot RCT that is comparing SCS plus usual care to 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.
 
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 (Dworkin, 2013). 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 2013, the American Society of Interventional Pain Physicians updated their evidence-based guidelines for interventional techniques in the management of chronic spinal pain (Manchikanti, 2013). The guidelines included the statement that there is fair evidence in support of SCS in managing patients with failed back surgery syndrome.
  
2015 Update
 
A literature search conducted through January 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
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 and colleagues included 36 patients, 22 were randomly assigned to SCS and 14 to continued best medical therapy (Slangen, 2014). 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 and colleagues randomized 40 patients to SCS and 20 to best medical therapy (de Vos, 2014). 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-value 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.
 
Heart Failure
Findings of a small pilot crossover RCT evaluating SCS for heart failure were published by Torre-Amione and colleagues (Torre-Amione, 2014).  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.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Refractory Chronic Trunk or Limb Pain
Standard Spinal Cord Stimulation
Two systematic reviews have focused on SCS specifically for complex regional pain syndrome (CRPS). Visnjevac et al reported on results of a systematic review of RCTs and observational studies of SCS for CRPS (Visnjevac, 2017). The Kemler trial, 2000 was the only RCT included, and it is discussed in the following section. The Cochrane overview of systematic reviews by O’Connell et al also focused on reviews of CRPS (O’Connell, 2013). The overview included reports from the Kemler RCT. Reviewers concluded that there was very low quality evidence using GRADE criteria that SCS using physical therapy was effective at reducing pain or improving quality of life in CRPS compared with physical therapy alone for up to 2 years.
 
Two systematic reviews have focused on SCS for failed back surgery syndrome (FBSS), defined as persistent pain after spinal surgery and the initial pain may have been secondary to various causes. Kapural et al reported on a systematic review of prospective studies of SCS for FBSS (Kapural, 2017)., The North and Kumar trials were the only RCTs included and are discussed in the following section. A systematic review of RCTs and observational studies evaluating SCS for FBSS was conducted by Frey et al (Frey, 2009). The 2 RCTs by North and Kumar were included. Using U.S Preventive Services Task Force quality ratings, reviewers 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 >1 center or research group) for the clinical use of standard SCS on a long-term basis.
 
High-Frequency SCS for Chronic Trunk or Limb Pain
Kapural et al included patients with chronic leg and back pain who had received conventional medical management but not SCS (Kapural, 2015; Kapural,2016). Kapural included an active but unblinded comparator (standard SCS) and included a trial SCS period up to 2 weeks postrandomization after which only responders continued with stimulation (Kapural, 2015). Outcomes were reported after 3, 12, and 24 months of treatment. The response in the standard SCS group was similar to previous trials of SCS, between 45% and 50% for back pain and 50% to 55% for leg pain at 3, 12, and 24 months. The response was clinically and statistically significantly higher with HFSCS than with SCS for both back (range, »75% to 85%) and leg pain (range, »70% to 85%) at all time points. A limitation of the Kapural trial was that nonresponders during the stimulation trial period were excluded from statistical analysis. Instead, assuming patients who were not implanted were nonresponders corresponds to response rates at 3 months of about 75% in HFSCS and 37% in SCS for back pain and 74% and 46% for leg pain (calculated, data not shown).
 
Al-Kaisy et al reported 36-month results for 20 patients with chronic low back pain without previous spinal surgery who were treated with 10-kHz HFSCS (Al-Kaisy, 2017). Seventeen patients completed the 36-month follow-up; 1 patient died (unrelated to study treatment), 1 patient was explanted due to lack of efficacy, and 1 patient had new leg pain. Among patients analyzed, the mean VAS score for pain intensity decreased from 79 to 10 mm (p<0.001) and the mean Oswestry Disability Index score decreased from 53 to 20 (p<0.001). At baseline, 90% of the patients were using opioids compared with 12% at 36 months.
 
SCS With Burst Stimulation
Five crossover RCTs with a total of 180 patients (range, 12-100 patients) were identified, 4 of which were conducted in Europe and the other in the United States. The trials by De Ridder et al enrolled patients with neuropathic pain, the trial by Schu et al enrolled patients with FBSS, Kriek et al enrolled patients with CRPS, and Deer et al enrolled patients with chronic intractable pain of the trunk and/or limbs (De Ridder, 2010; DeRidder, 2013; Schu, 2014; Kriek, 2017; Deer, 2018). All trials compared burst stimulation with SCS. Schu, De Ridder, and Kriek also compared burst with a sham stimulation group (Schu, 2014; De Ridder, 2013; and Kriek, 2017). Schu included patients receiving standard SCS while De Ridder and Deer  included patients not previously treated with SCS (Schu, 2014; De Ridder, 2010; De Ridder 2013; Deer, 2018). It was not clear in Kriek whether patients had previously received SCS (Kriek, 2017). Results were reported for 1 week of stimulation in Schu and De Ridder after two, 1-hour sessions of SCS or burst in De Ridder, after 2 weeks of stimulation in Kriek, and after 12 weeks of stimulation in Deer (Schu, 2014; De Ridder, 2013; De Ridder, 2010; Kriek, 2017; Deer, 2018). All trials reported reductions in absolute pain scores (NRS or VAS). Schu and De Ridder did not account for their crossover designs in data analyses, so analyses and p values are incorrect and not reported (Schu, 2014; De Ridder, 2013.  De Ridder did not provide between-group comparisons (De Ridder, 2010). Kriek reported only per-protocol analyses. Four trials reported numerically larger reductions in pain scores with burst than with SCS; Kriek did not report less pain for SCS at any frequency compared with burst. In Kriek, 48% of patients preferred the 40-Hz SCS compared with 21%, 14%, 14%, and 3% that preferred 500-Hz SCS, 1200-Hz SCS, and burst and sham, respectively (Kriek, 2017). The interpretation of the four of the trials was limited by small sample sizes, short follow-up, and incorrect, inadequate, or missing statistical analyses.
 
The largest trial of burst stimulation is the Success Using Neuromodulation with BURST (SUNBURST) trial reported by Deer et al (Deer, 2018). SUNBURST was a 12-week, multicenter, randomized, unblinded, crossover, non-inferiority trial evaluating traditional SCS or burst stimulation in 100 patients with chronic pain of the trunk and/or limbs enrolled between January 2014 and May 2015. Patients were SCS-naive and completed a trial stimulation period. Forty-five patients were randomized to SCS then burst, and the remaining 55 were randomized to burst then SCS. At the end of the second crossover period, patients were allowed to choose the stimulation mode they preferred and were followed for 1 year. Patients’ mean age was 59 years; 60% of patients were women; and 42% of patients had FBSS while 37% had radiculopathies. The primary outcome was the difference in mean VAS score, with a noninferiority margin of 7.5 mm. Analyses were intention-to-treat with missing values imputed using the hot deck method. Also, outcomes were imputed for patients who underwent invasive procedures for pain or had medication increases. The estimated difference in the overall VAS score between burst and SCS was -5.1 mm (95% upper confidence interval [CI], -1.14 mm), demonstrating noninferiority (p<0.001) and superiority (p<0.017). The proportion of patients with a decrease in VAS score of 30% or more was 60% (60/100) during burst stimulation and 51% (51/100) during SCS. The proportion of patients whose global impression was minimally improved, moderately improved, or very much improved was approximately 74% in both groups. There were no significant differences in Beck Depression Inventory scores (p=0.230). Patients were asked to rate their satisfaction levels for both periods: 78% were satisfied with both SCS and burst, 4% were dissatisfied with both SCS and burst, 7% were satisfied with SCS but not burst, and 10% were satisfied with burst but not SCS. However, more patients (70.8%) reported preferring burst stimulation over SCS stimulation after the 24-week crossover period. After 1 year of follow-up, 60 (68%) of the 88 patients completing follow-up reported preferring burst stimulation. The authors reported that the programming parameters were not standardized at the beginning of the study but a more standardized approach with lower amplitudes was implemented as the trial was ongoing. Trial limitations included the crossover design, which limits comparison of pain over longer periods of time, lack of blinding, and variable burst programming parameters.
 
Dorsal Root Ganglion Neurostimulators for Chronic Trunk or Limb Pain
Studies offering direct comparisons between standard SCS and dorsal root ganglion (DRG) neurostimulators were sought to evaluate the benefits of SCS.
 
DRG Implanted Device
Chang Chien et al published a systematic review on intraspinal stimulation of nondorsal column targets, including neurostimulation of the DRG for chronic pain (Chang Chien, 2017). Reviewers included reports published through March 2015. They identified 6 studies of DRG stimulation: 1 conference presentation of the preliminary RCT data from the ACCURATE trial (discussed below), 4 publications describing 3 prospective observational studies, and 1 retrospective chart review. In the 3 prospective observational studies (N=32, 10, and 8), follow-up ranged from 7 days to 12 months. The retrospective study reported on 25 patients with a follow-up to 32 weeks.

CPT/HCPCS:
63650Percutaneous implantation of neurostimulator electrode array, epidural
63655Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural
63685Insertion or replacement of spinal neurostimulator pulse generator or receiver, direct or inductive coupling
63688Revision or removal of implanted spinal neurostimulator pulse generator or receiver
95970Electronic analysis of implanted neurostimulator pulse generator system (eg, 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 (ie, cranial nerve, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, without reprogramming
95971Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); simple spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming
95972Electronic analysis of implanted neurostimulator pulse generator system (eg, rate, pulse amplitude, pulse duration, configuration of wave form, battery status, electrode selectability, output modulation, cycling, impedance and patient compliance measurements); complex spinal cord, or peripheral (ie, peripheral nerve, sacral nerve, neuromuscular) (except cranial nerve) neurostimulator pulse generator/transmitter, with intraoperative or subsequent programming
L8680Implantable neurostimulator electrode, each
L8685Implantable neurostimulator pulse generator, single array, rechargeable, includes extension
L8686Implantable neurostimulator pulse generator, single array, nonrechargeable, includes extension
L8687Implantable neurostimulator pulse generator, dual array, rechargeable, includes extension
L8688Implantable neurostimulator pulse generator, dual array, nonrechargeable, includes extension

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