Spinal Cord Stimulation for the Treatment of Pain
DESCRIPTION
Standard spinal cord stimulation (SCS; also known as dorsal column stimulation) delivers low-frequency electrical stimulation percutaneously into the epidural space of the spinal cord to block the sensation of pain for individuals with chronic neuropathic pain in the trunk or limbs. SCS has been proposed for a wide variety of chronic refractory pain conditions, including pain associated with cancer, failed back pain syndromes, arachnoiditis, and complex regional pain syndrome. An additional SCS modality is high-frequency spinal cord stimulation, which uses electrical stimulation at 10-kHz, and is sometimes referred to as HF-10 therapy.
Spinal cord stimulation devices consist of implantable electrodes, a receiver/transducer, and a programmable transmitter that may be worn externally or may be fully implanted. An initial trial period of approximately 5 to 10 days is usually required, and if considered successful would be followed by implantation of the permanent spinal cord stimulator. Clinical trials typically define ‘success’ as a 45-50% or greater reduction in pain scores at the end of the 5 to 10 day trial period, even if that reduction was not sustained.
Dorsal root ganglion (DRG) are located between spinal nerves and the spinal cord on the posterior root and play an important role in neuropathic pain perception. Two examples of systems targeting the dorsal root ganglion have received approval or clearance from FDA. The Freedom® Spinal Cord Stimulator is a wireless injectable stimulator for treating chronic, intractable pain of the trunk and/or lower limbs. The device can be placed to target the spinal cord or dorsal root ganglion. The Axium® is an implanted system that delivers electrical stimulation to the dorsal root ganglion.
POLICY
Spinal cord stimulation is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Dorsal root ganglion stimulation is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Spinal cord stimulation, either standard or high frequency, for the treatment of pain associated with conditions/diseases including, but not limited to, the following is considered investigational:
Intractable angina
Plexus lesions caused by trauma or malignancy
Multiple sclerosis and spasticity disorders
Paraplegia and other spinal cord lesions
Nociceptive pain resulting from irritation to the nerves
Acute peripheral nerve injuries or deafferentation pain (related to central nervous system damage from stroke, spinal cord injury, surgery, entrapment, or scars)
Postherpetic neuralgia
Critical limb ischemia to forestall amputation
Cancer-related pain
Heart failure
Any spinal cord stimulator utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Spinal cord stimulation (SCS) is considered medically appropriate if ALL of the following are met:
Indicated for ANY ONE of the following:
A trial treatment with temporarily implanted epidural spinal cord stimulator or dorsal root ganglion stimulator when ALL of the following are met:
Neuropathic pain, including but not limited to, failed back surgery syndrome, complex regional pain syndrome (i.e., reflex sympathetic dystrophy), arachnoiditis, radiculopathies, phantom limb/stump pain, peripheral neuropathy.
Chronic intractable pain of the trunk or limbs
Other treatment modalities (e.g., pharmacologic, surgical, physical, or psychologic therapies) have been tried for at least 6 months and failed, or were judged unsuitable, or contraindicated
Revision surgery is not an option or would have low chance of success
No serious, untreated drug habituation exists
Individual has undergone careful screening, evaluation, and diagnosis by a multi-disciplinary team.
Psychological evaluation obtained
A permanently implanted epidural spinal cord stimulator or dorsal root ganglion stimulator when ALL of the following are met:
Demonstration of pain relief for a duration of 5 - 10 days with temporarily implanted electrode
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
SOURCES
American Academy of Pain Medicine. (2008, June). Position statement on spinal cord neurostimulation. Retrieved June 13, 2017 from http://www.painmed.org/research/position-statements.
American Association of Neurological Surgeons. (2018). Spinal cord stimulation. Retrieved May 21, 2018 from www.aans.org.
American Society of Interventional Pain Physicians. (2013). An update of comprehensive evidence-based guidelines for interventional techniques of chronic spinal pain. Part II: guidance and recommendations. Retrieved May 12, 2016 from www.painphysicianjournal.com.
BlueCross BlueShield Association. Evidence Positioning System. (5:2023). Spinal cord and dorsal root ganglion stimulation (7.01.25). Retrieved August 14, 2023 from https://www.evidencepositioningsystem.com/. (87 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for electrical nerve stimulators (160.7). Retrieved April 15, 2019 from http://www.cms.gov.
Deer, T.R., Levy, R.M., Kramer, J., Poree, L., Amirdelfan, K., Grigsby, E., et al. (2017). Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain, 158 (4), 669-681. (Level 2 evidence)
Grider, J., Manchikanti, L., Carayannopoulos, A., Sharma, M. L., Balog, C. C., Harned, M. E., et al. (2016). Effectiveness of spinal cord stimulation in chronic spinal pain: a systematic review. Pain Physician, 19, E33-E54. (Level 2 evidence)
International Neuromodulation Society. (2018, September). The neuromodulation appropriateness consensus committee on best practices for dorsal root ganglion stimulation. Retrieved April 16, 2019 from PubMed database.
Kapural, L. Yu, C., Doust, M. W., Gliner, B. E., Vallejo, R., Sitzman, B. T., et al. (2015). Novel 10-kHz high-frequency therapy (HF10 Therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: the SENZA-RCT randomized controlled trial. Anesthesiology, 123 (4), 851-860. (Level 1 evidence)
Kapural, L. Yu, C., Doust, M. W., Gliner, B. E., Vallejo, R., Sitzman, B. T., et al. (2016). Comparison of 10-kHz high-frequency and traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: 24-month results from a multicenter, randomized, controlled pivotal trial. Neurosurgery, 79 (5), 667-678. (Level 1 evidence)
Kapural, L., Peterson, E., Provenzano, D.A., & Staats, P. (2017). Clinical evidence for spinal cord stimulation for failed back surgery syndrome (FBSS): systematic review. Spine, 42 (Suppl 14), S61-S66. (Level 2 evidence)
National Institute for Health and Care Excellence. (2008, October; last updated February 2014). Technology appraisal guidance: Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin. Retrieved May 17, 2018 from http://www.nice.org.uk.
U. S. Food and Drug Administration. Center for Devices and Radiological Health. (2004, April). Premarket Notification Database. P030014 (Precision™ Spinal Cord Stimulation System). Retrieved October 9, 2009, from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. Center for Devices and Radiological Health. (2015, May). Premarket Notification Database. P130022 (Nevro Senza™ Spinal Cord Stimulation System). Retrieved May 16, 2016 from http://www.accessdata.fda.gov.
Visnjevac, O., Costandi, S., Patel, B.A., Azer, G., Agarwal, P., Bolash, R., & Mekhail, N.A. (2017). A comprehensive outcome-specific review of the use of spinal cord stimulation for complex regional pain syndrome. Pain Practice, 17 (4), 533-545. Abstract retrieved May 17, 2018 from PubMed database.
Vuka, I., Marcius, T., Dosenovic, S., Hamzic, L.F., Vucic, K., Sapunar, D., et al. (2019). Neuromodulation with electrical field stimulation of dorsal root ganglion in various pain syndromes: a systematic review with the focus on participant selection. Journal of Pain Research, 12, 803-830. (Level 3 evidence)
Winifred S. Hayes, Inc. Health Technology Assessment. (2021, December; last search update March 2023). Dorsal root ganglion stimulation for the treatment of complex regional pain syndrome. Retrieved August 14, 2023 from www.Hayesinc.com/subscribers. (43 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2015, October; last search update March 2023). Spinal cord stimulation for relief of neuropathic pain. Retrieved August 14, 2023 from www.Hayesinc.com/subscribers. (84 articles and/or guidelines reviewed)
Zhou, M., Zhong, H., Xing, C., Li, H., Liu, S., Wang, L., et al. (2023). Comparison of clinical outcomes associated with spinal cord stimulation (SCS) or conventional medical management (CMM) for chronic pain: a systematic review and meta-analysis. European Spine Journal, 32 (6), 2029–2041. Abstract retrieved August 15, 2023 from PubMed database.
ORIGINAL EFFECTIVE DATE: 3/1980
MOST RECENT REVIEW DATE: 10/12/2023
ID_BT
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