Clinical Policy: Spinal Cord, Peripheral Nerve, and Percutaneous Electrical Nerve Stimulation Form
YesNoN/A
YesNoN/A
YesNoN/A
# Clinical Policy: Spinal Cord, Peripheral Nerve, and Percutaneous Electrical Nerve Stimulation
Reference Number: CP.MP.117
Date of Last Revision: 11/24
[Coding Implications](#)
[Revision Log](#)
See [Important Reminder](#) at the end of this policy for important regulatory and legal information.
## Description
Peripheral nerve stimulation (PNS) is intended to decrease chronic and acute pain by stimulating peripheral nerves with leads placed adjacent or parallel to the affected nerve.¹⁸ PNS can be used in a trial of pain relief effectiveness, or for permanent placement. In peripheral nerve field stimulation (PNFS), leads are placed in the region in which the pain is felt, stimulating smaller peripheral nerves and nerve endings.¹⁸ PNFS is useful when one nerve does not clearly service the painful area.
Percutaneous electrical nerve stimulation (PENS) uses fine needles as electrodes, which are placed in the soft tissues or muscles at dermatomal levels consistent with pain or local pathology. It is similar to transcutaneous electrical nerve stimulation but bypasses the local skin resistance and delivers electrical current closer to the affected tissues. Percutaneous electrical nerve field stimulation (PENFS) is a variation of PENS that targets an area of pain instead of targeting a specific nerve.
The dorsal column stimulator (DCS), or spinal column stimulator (SCS) is a device that allows for electrical stimulation of the dorsal aspect of the spinal cord nerves in an effort to relieve pain in patients with a variety of chronic pain disorders. In most cases, neuropathic pain responds poorly to standard pharmacological and surgical therapies and can last indefinitely with increasing severity over time. It may result in severe disability. Stimulation in this area interferes with the conduction of pain impulses through adjacent sensory pathways and may stimulate endorphins. The technique does not alter the underlying pathological process. However, in selective patients with persistent and intractable pain of nerve origin, approximately 50 percent of patients will have pain relief, thereby decreasing the need for analgesic medication and at times obviating the need for further surgical procedures.
*Note: For other types of peripheral nerve stimulation, please refer to:*
- CP.MP.40 Gastric Electrical Stimulation
- CP.MP.137 Fecal Incontinence Treatments
- CP.MP.133 Posterior Tibial Nerve Stimulation for Voiding Dysfunction
- CP.MP.12 Vagus Nerve Stimulation
- CP.MP.203 Diaphragmatic/Phrenic Nerve Stimulation
## Policy/Criteria
1. It is the policy of health plans affiliated with Centene Corporation® that there is insufficient evidence to support the efficacy of peripheral nerve stimulation or peripheral nerve field stimulation for any indication.
# Clinical Policy
Spinal Cord, Peripheral Nerve, and Percutaneous Electrical Nerve Stimulation
III. It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence to support the efficacy of percutaneous electrical nerve field stimulation (PENFS) for any indication, including irritable bowel syndrome (IBS).
V. It is the policy of health plans affiliated with Centene Corporation that there is insufficient evidence to support the efficacy of dorsal root ganglion (DRG) stimulation.
## Background
### Peripheral nerve stimulation (PNS)
Evidence supporting peripheral nerve stimulation (PNS) is limited. According to a systematic review by Xu et al., there is a lack of high-quality randomized control trials to recommend PNS for most pain management indications.¹⁹ They cited wide variations in experimental design, research protocol, and heterogeneity of study population as limitations preventing a meta-analysis.¹⁹ Xu et al. stated that PNS had level I and Level II evidence supporting its efficacy for migraine/chronic headache.¹⁹ However, the large multicenter randomized clinical trial (RCT) included in the systematic review, conducted by Dodick et al. studying the effect of PNS for migraine headache, also noted adverse events among 70% of the study sample, with 48% of the patients with adverse events requiring hospitalization or further surgical intervention to treat the complication.²⁰ An additional systematic literature review noted moderate to strong evidence for peripheral nerves stimulation, but surveyed the literature as a whole for an array of pain indications, noting that further research could help “further refine appropriate populations and pain diagnoses.”²⁶ Hayes notes that there is insufficient evidence to evaluate the efficacy of peripheral nerve stimulation for back pain, or chronic neck pain.¹⁸
### Peripheral nerve field stimulation (PNFS)
Hayes notes two available RCTs addressing PNFS for chronic low back pain, stating they were of low quality due to inability to blind patients and/or researchers, low sample sizes, and short follow-up periods.²⁷ An additional RCT evaluated subcutaneous PNFS combined with spinal cord stimulation (SCS) for refractory low back pain, concluding that PNFS significantly decreased pain compared to SCS alone.²⁸ Study limitations included industry ties amongst investigators and small sample sizes.²⁸ There were too few high-quality studies to support the safety or efficacy of PNFS for other indications.
### Percutaneous electrical nerve stimulation (PENS)
The American Academy of Neurology’s 2011 guideline on treatment of painful diabetic neuropathy gives a B-grade recommendation for PENS as a treatment modality. They note one class I trial comparing PENS to sham treatment, yielding a 42% reduction in pain according to the visual analog scale.²² The National Institute for Clinical Health and Care Excellence (NICE) also recommends PENS for refractory neuropathic pain, noting evidence of short-term efficacy and no significant safety concerns. NICE guidelines cite evidence from two RCTs with 64 and 50 patients, respectively, demonstrating significant reduction in pain and favorable safety profiles.²⁵
### Percutaneous electrical nerve field stimulation (PENFS)
PENFS is a variation of PENS that targets a general area of pain as opposed to a specific nerve. PENFS is emerging as a promising noninvasive auricular neurostimulation therapy to treat disorders of gut-brain interaction (DGBI) with study populations including children and adolescents.³¹,³⁴,³⁵ Although study findings are promising, additional studies are needed before PENFS can be routinely recommended for children and adolescents with functional abdominal pain (FAP).³⁵
The IB-Stim (NeurAxis Inc.) is a PENFS designed to relieve functional abdominal pain and is cleared by the U.S. Food and Drug Administration (FDA) for the treatment of abdominal pain in adolescents with irritable bowel syndrome (IBS). According to a Hayes review, clinical studies suggest no or unclear support for the use of IB-Stim in the treatment of IBS in adolescents, and there are no professional guidelines that currently offer recommendations for PENFS in this population. In the Hayes review, only one fair quality trial was identified, and IB-Stim was not compared to other active treatments and did not report clear benefits in patient outcomes compared to sham past three to four weeks of study follow up.³¹
### Spinal cord stimulation (SCS)
SCS is currently used to treat a wide variety of inoperable and intractable chronic pain syndromes, including failed back surgery syndrome and complex regional pain syndrome (CRPS). In patients with failed conservative and surgical treatment of lower-limb ischemia, SCS increases skin blood flow, decreases pain, and improves quality of life. Four studies used inferential statistics and found pain reduction to be significant. At least 50% pain reduction at follow-up was found in 78%, 80%, and 85% of patients in the three studies that reported this data. Follow-up ranged from six to 35 months.
According to recent systematic reviews, the most favorable results have been observed in patients with peripheral vascular disease, complex regional pain syndrome, and peripheral neuropathy (e.g., diabetic or causalgic origin). Of interest, the pain relief achieved with SCS in patients with complex regional pain syndrome is possible without vasodilation. The vasodilation found with SCS is attributed to an inhibitory effect on sympathetically maintained vasoconstriction. Diabetic patients with peripheral arterial occlusive disease who present with intractable pain have also been successfully treated with SCS, except those who have severe autonomic neuropathy. Recently, SCS has been successfully used to treat intractable angina pectoris and chronic mesenteric ischemia.
Spinal cord stimulation is proposed as a late or last resort treatment for chronic pain due to stable angina pectoris. Although most of the research reviewed used subjective outcome measures and some studies lacked prospective design, adequate sample size, and control groups, SCS was shown to alleviate pain and reduce myocardial ischemia in many of the study patients for whom pain relief was previously unobtainable. SCS has also been shown to reduce service utilization in aggregate among the recipients. Side effects, while not infrequent, are rarely serious and can usually be resolved by the reimplantment, or replacement of the device. Evidence indicates that the analgesic effect of SCS in angina does not mask the warning pain of myocardial infarction. Patients who have been treated with SCS have not been shown to be at an increased risk for morbidity or mortality compared with their peers. Although a minority of patients receiving a trial of SCS ultimately experience prolonged pain relief, the significance of the alleviation of
pain and suffering among those who do cannot be underestimated. Therefore, spinal cord stimulation for chronic stable angina pectoris secondary to demonstrable myocardial ischemia in patients who are refractory to treatment should be considered.
Slangen et al., performed a multicenter randomized clinical trial in 36 painful diabetic peripheral neuropathy (PDPN) patients with severe lower limb pain not responding to conventional therapy.¹³ The authors concluded treatment success was shown in 59% of patients with PDPN who were treated with SCS over a six month period, although this treatment is not without risks. Two-year outcomes of the same study reported clinically significant improvements in pain and sleep in 53% of patients. Additionally, a randomized controlled trial of 60 patients, conducted by de Vos and colleagues, found that pain due to PDPN was significantly reduced from baseline at 6 months, and quality of life was improved.
### Dorsal Root Ganglion (DRG) Stimulation
Hayes notes that currently there is insufficient evidence to determine the effectiveness and safety of DRG stimulation for adults with CRPS. According to Hayes, there is limited evidence suggesting that DRG stimulation for CRPS may result in successful outcomes for pain, quality of life, and mood, but conclusions could not be made due to the limited quantity of evidence, individual study limitations such as small sample sizes, and limited follow up. Additional high quality comparative studies are recommended to evaluate the benefits and risks of DRG stimulation for CRPS.⁸
## Coding Implications
This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2023, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. The inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.
### CPT Codes That Do Not Support Coverage Criteria
| CPT® Codes | Description |
|------------|-------------|
| 0720T | Percutaneous electrical nerve field stimulation, cranial nerves, without implantation |
### CPT Codes That Support Coverage Criteria
| CPT Codes | Description |
|-----------|-------------|
| 63650 | Percutaneous implantation of neurostimulator electrode array, epidural |
| 63655 | Laminectomy for implantation of neurostimulator electrodes, plate/paddle, epidural |
| CPT Codes | Description |
|-----------|-------------|
| 63685 | Insertion or replacement of spinal neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver |
| 64555 | Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve) |
| 64575 | Open implantation of neurostimulator electrode array; peripheral nerve (excludes sacral nerve) |
| 64585 | Revision or removal of peripheral neurostimulator electrode array |
| 64590\* | Insertion or replacement of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, requiring pocket creation and connection between electrode array and pulse generator or receiver |
| 64595\* | Revision or removal of peripheral, sacral, or gastric neurostimulator pulse generator or receiver, with detachable connection to electrode array |
| 64596 | Insertion or replacement of percutaneous electrode array, peripheral nerve, with integrated neurostimulator, including imaging guidance, when performed; initial electrode array |
| 64597 | Insertion or replacement of percutaneous electrode array, peripheral nerve, with integrated neurostimulator, including imaging guidance, when performed; each additional electrode array |
| 64598 | Revision or removal of neurostimulator electrode array, peripheral nerve, with integrated neurostimulator |
| 64999 | Unlisted procedure, nervous system |
| 95970 | Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with brain, cranial nerve, spinal cord, peripheral nerve, or sacral nerve, neurostimulator pulse generator/transmitter, without programming |
| 95971 | Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with simple spinal cord or peripheral nerve (e.g., sacral nerve) neurostimulator pulse generator/transmitter programming by physician or other qualified health care professional |
| 95972 | Electronic analysis of implanted neurostimulator pulse generator/transmitter (e.g., contact group[s], interleaving, amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet mode, dose lockout, patient selectable parameters, responsive neurostimulation, detection algorithms, closed loop parameters, and passive parameters) by physician or other qualified health care professional; with complex spinal cord or peripheral nerve (e.g., sacral nerve) neurostimulator |
pulse generator/transmitter programming by physician or other qualified health care professional
\*For gastric electrical stimulation, refer to CP.MP.40 Gastric Electrical Stimulation
### HCPCS Codes That Support Coverage Criteria
| HCPCS Codes | Description |
|-------------|-------------|
| L8687 | Electrical stimulator supplies (external) for use with implantable neurostimulator, per month |
| L8679 | Implantable neurostimulator, pulse generator, any type |
| L8680 | Implantable neurostimulator electrode, each |
| L8681 | Patient programmer (external) for use with implantable programmable neurostimulator pulse generator, replacement only |
| L8682 | Implantable neurostimulator radiofrequency receiver |
| L8683 | Radiofrequency transmitter (external) for use with implantable neurostimulator radiofrequency receiver |
| 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 |
### Reviews, Revisions, and Approvals
| Policy split from CP.MP.63 Pain Management Procedures. Added chronic lower limb ischemia indication in I. C per Cochrane review of effectiveness. I.D. Case-by-case indications: Added indications in I.D, per American Association of Neurological Surgeons 2008 information on SCS, and 2010 American Society of Anesthesiologists guidelines; added diabetic neuropathy indication. Added requirement for reversible ischemia documented by treadmill exercise test, per inclusion criteria in study by de Jongste. Added ICD-10 codes for diabetic neuropathy. | 07/16 | 07/16 |
| References reviewed and updated. Codes updated | 3/19 | 04/19 |
| Annual review completed. References and codes reviewed and updated. Reviewed by specialist. | 2/20 | 03/20 |
| Annual review completed. References and codes reviewed and updated. Changed “members” to “members/enrollees” throughout policy. Split CPT category G57.80-G57.93 into 2 separate code ranges along with applicable descriptions. | 2/21 | |
| Revised I.A.6&7, B.6&7, C.4&5, D.5&6, and E.8&9, to strengthen criteria for psychological evaluation and drug abuse. | 03/21 | 04/21 |
| Annual review. Changed policy title to include peripheral nerve and percutaneous electrical nerve stimulation. Added note referring to other policies with criteria for specific types of peripheral nerve stimulation. Added policy statement, background, and references regarding peripheral nerve stimulation and peripheral nerve field stimulation in I. Added criteria, background, and references regarding percutaneous electrical nerve stimulation (PENS). Updated procedure codes. Added “chronic back pain” to criteria III.D.1. Changed “Review Date” in header to “Revision Date” and “Date” in the revision log header to “Revision Date.” References reviewed and updated. Reviewed by specialist. | 02/22 | 02/22 |
| Annual review. Criteria IIA. updated verbiage to include “diagnosis of” neuropathic pain. Added Criteria IIL.D. regarding PENS not being used to treat low back pain. Updated Criteria III.A.3. to state, “Not a suitable candidate for or opposes additional surgery.” Criteria III.D.1. added “peripheral.” Criteria III.D.1.1. updated to say “Chronic, intractable back pain and/or lumbar radiculopathy.” Added Criteria III.D.3. Criteria III.D.4. updated to include examples of conservative therapy. Criteria III.F.4. updated to include “…same brand and model…” Added criteria IV. Regarding insufficient evidence to support dorsal root ganglion (DRG) stimulation. Background updated to include information regarding DRG stimulation for complex regional pain syndrome. Removed ICD-10 codes. References reviewed and updated. Reviewed by internal specialists. | 02/23 | 02/23 |
| Annual review. Updated description and background with no clinical significance. Coding reviewed. References reviewed and updated. | 01/24 | 01/24 |
| Description updated with no impact on criteria. Added Criteria III. stating that there is insufficient evidence to support the efficacy of PENFS for any indication, including irritable bowel syndrome (IBS). Background updated with information to support updated criteria regarding PENFS. Added CPT code 0720T as not covered. References reviewed and updated. | 05/24 | 05/24 |
| Annual review. Coding reviewed and descriptions updated as needed. Added codes 64596, 64597, 64598, and L8687. References reviewed and updated. | 11/24 | 11/24 |
Page 12 of 14
CLINICAL POLICY
Spinal Cord, Peripheral Nerve, and Percutaneous Electrical Nerve Stimulation
31. Evolving Evidence Review. IB-Stim (NeurAxis) for treatment of pain associated with irritable bowel syndrome in adolescents. Hayes. www.hayesinc.com. Published July 14, 2022 (annual review July 17, 2024). Accessed October 25, 2024.
32. Lacy BE, Pimentel M, Brenner DM, et al. ACG Clinical Guideline: Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2021;116(1):17-44. doi:10.14309/ajg.00000000000001036
33. Vasant DH, Paine PA, Black CJ, et al. British Society of Gastroenterology guidelines on the management of irritable bowel syndrome. Gut. 2021;70(7):1214-1240. doi:10.1136/gutjnl-2021-324598
34. Karrento K, Zhang L, Conley W, et al. Percutaneous electrical nerve field stimulation improves comorbidities in children with cyclic vomiting syndrome. Front Pain Res (Lausanne). 2023;4:1203541. Published 2023 Jun 14. Doi:10.3389/fpain.2023.1203541
35. Chacko MR, Chiou EH. Functional abdominal pain in children and adolescents: Management in primary care. UpToDate. www.uptodate.com. Published September 30, 2024. Accessed October 25, 2024.
Page 14 of 14
Book a walkthrough
Walk through this policy with us
Review how this policy can be converted into cited criteria, prior authorization checks, and operational automation.
Loading available demo times