Spinal Cord Stimulation for Treatment of Pain
DESCRIPTION
Spinal cord stimulation (SCS), as a treatment of a wide variety of chronic, intractable pain involves the use of electrical stimulation on the dorsal columns by implantation of electrodes in the epidural space along the spinal column. 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. This modality requires a trial period of approximately 5-10 days and if considered successful would be followed by implantation of the permanent spinal cord stimulator.
POLICY
A trial spinal cord stimulation period, with a temporarily implanted electrode, for the treatment of pain is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Spinal cord stimulation with a permanently implanted electrode for the treatment of pain is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Spinal cord stimulation 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
Peripheral nerve injuries or deafferentation, which includes neuropathy due to injuries, surgery, entrapment or scars
Postherpetic neuralgia
Critical limb ischemia to forestall amputation
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 is considered medically appropriate if ALL of the following:
ANY ONE of the following:
As a trial treatment of pain with temporarily implanted electrodes
As a permanent implantation of a spinal cord stimulator following demonstrated pain relief from a temporarily implanted electrode for a duration of 5 - 10 days
ANY ONE of the following diseases or conditions:
Radiculopathies (diseases or conditions involving the nerve roots, including failed back surgery syndrome [FBSS], arachnoiditis and epidural fibrosis)
Reflex sympathetic dystrophy (also known as complex regional pain syndrome type 1
Intractable pain from severe peripheral vascular disease (e.g. peripheral neuropathy)
Phantom limb/stump pain
SCS is a late or last resort for an individual with chronic intractable pain
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
Careful screening, evaluation, and diagnosis by a multi-disciplinary team are undertaken prior to the implantation. Such screening must include psychological as well as physical evaluation
ABSENCE of serious, untreated drug habituation
IMPORTANT REMINDER
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, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Controlled studies were not found in the published literature that validates the application of spinal cord stimulation for the treatment of pain associated with conditions/diseases including, but not limited to, those specified in the investigational statement.
SOURCES
American Society of Interventional Pain Physicians. (2009). Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal. Retrieved September 6, 2011 from http://www.painphysicianjournal.com/2009/july/2009;12;699-802.pdf.
Blue Cross Blue Shield Association. Medical Policy Reference Manual. (1:2011). Spinal cord stimulation (7.01.25). Retrieved August 17, 2011 from BlueWeb. (20 articles and/ or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Electrical nerve stimulators (NCD 160.7, p. 2-79). Ingenix.
Fricke, E., Eckert, S., Dongas, A., Fricke, H., Preuss, R., Lindner, O., et al. (2009). Myocardial perfusion after one year of spinal cord stimulation in patients with refractory angina. Nuclear Medicine, 48 (3), 104 - 109. (Level 4 Evidence)
National Guideline Clearinghouse. National Center for Primary Care. (2007 September). European Federation of Neurological Societies (EFNS) guidelines on neurostimulation therapy for neuropathic pain. Retrieved September 6, 2011 from http://www.guideline.gov.
National Guideline Clearinghouse. National Center for Primary Care. (2007 March). Assessment and management of chronic pain. Retrieved November 5, 2009 from http://www.guideline.gov.
National Institute for Health and Clinical Excellence. (2011, November). Spinal cord stimulation for chronic pain of neuropathic or ischaemic origin. Retrieved September 6, 2011 from http://www.nice.org.uk/nicemedia/live/12082/42367/42367.pdf.
Taylor, R., DeVries, J., Buchser, E., & Dejongst, M. (2009). Spinal cord stimulation in the treatment of refractory angina: systematic review and meta-analysis of randomised controlled trials. BMC Cardiovascular Disorders, 9 (13). (Level 1 Evidence)
U. S. Food and Drug Administration. Center for Devices and Radiological Health. (2004, April). FDA Approval Letter: Precision™ Spinal Cord Stimulation (SCS) System. Retrieved October 9, 2009, from http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030017b.pdf.
U.S. Food and Drug Administration. (2009, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K083124. Retrieved October 9, 2009 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K083124.pdf.
Viswanathan, A., Phan, P, & Burton, A. (2010) Use of spinal cord stimulation in the treatment of phantom limb pain: a case series and review of literature. Pain Practice, 10 (5), 479-484. (Level 3 Evidence - Independent)
Winifred S. Hayes, Inc. Medical Technology Directory. (2006, September, last update search August 2010). Electrical spinal cord stimulation for the treatment of intractable angina pectoris. Retrieved September 6, 2011 from www.Hayesinc.com/subscribers. (54 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2009, March, last update search March 2011). Spinal cord stimulation for relief of neuropathic pain. Retrieved September 6, 2011 from www.Hayesinc.com/subscribers. (65 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/1980
MOST RECENT REVIEW DATE: 10/13/2011
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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