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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 have a radiofrequency receiver that is surgically implanted and a power source (battery) that is either implanted or worn externally.
Spinal cord stimulation (SCS; also called dorsal column stimulation) involves the use of low-level epidural electrical stimulation of the spinal cord dorsal columns. The neurophysiology of pain relief after spinal cord stimulation is uncertain, but may be related to either activation of an inhibitory system or to blockage of facilitative circuits. 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 (ie, 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.
Spinal cord stimulation 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. 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.
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.
A large number of neruostimulator devices, some used for spinal cord stimulation, have received U.S. Food and Drug Administration (FDA) premarket approval (PMA). Examples of fully implantable spinal cord stimulation devices approved through the PMA process include the Cordis programmable neurostimulator (Cordis, Corp., Downers Grove, IL), approved in 1981, the Itrel® (Medtronic, Minneapolis, MN), approved in 1984, and the Precision Spinal Cord Stimulator (Advanced Bionics, Switzerland), approved in 2004.
In May 2015, FDA approved the Nevro Senza™ Spinal Cord Stimulator (Nevro Corp., Menlo Park, CA), a totally implantable neurostimulator device, for the following indications: “chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain.” This device uses a higher frequency of electrical stimulation (10 kHz) than standard devices.
Deep Brain Stimulation of the thalamus as a treatment of tremor is addressed in a separate policy.
Spinal cord stimulation with standard (non-high-frequency) stimulation may be considered medically necessary for the treatment of severe and chronic pain of the trunk or limbs that is refractory to all other pain therapies, when performed according to policy guidelines.
High-frequency spinal cord stimulation is investigational for the treatment of severe and chronic pain of the trunk or limbs.
Spinal cord stimulation is considered investigational in all other situations including but not limited to treatment of critical limb ischemia to forestall amputation and treatment of refractory angina pectoris, heart failure, and cancer-related pain.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
Patient selection focuses on determining whether the patient is refractory to other types of treatment. The following considerations may apply.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
6/1993: Approved by Medical Policy Advisory Committee (MPAC)
3/2001: Policy reviewed; Hyperlinks inserted under Policy, Managed Care Requirements deleted, Sources updated
2/15/2002: Investigational definition added
3/6/2002: Individual consideration requirement deleted
5/7/2002: Type of Service and Place of Service deleted
2/21/2005: CPT 63685 , 95970 , 95971 , 95972 , 95973 description revised, CPT 63690-63691 deleted 1999, ICD-9 procedure codes 02.93, 03.93 description revised, HCPCS E0751 deleted 2001, HCPCS E0753 deleted 2002
10/26/2005: Code Reference section updated; CPT-4: 63660 added; ICD-9 Procedure: 02.93 deleted; 03.94, 86.94, 86.95, 86.96 added; HCPCS: E0752, E0754 added
11/15/2005: ICD9 procedure codes 86.97, 86.98 added
3/14/2006: Coding updated. HCPCS 2005 & 2006 revisions added to policy
4/1/2008: Policy reviewed, no changes
12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions
1/8/2009: Policy reviewed, no changes
12/16/2009: Coding Section revised for 2010 CPT4 and HCPCS revisions
04/27/2010: Policy description re-written extensively to provide information on various conditions spinal cord stimulation is used for, FDA status of devices, and techniques for device placement. Policy statement updated to add “and as a treatment for refractory angina pectoris” to the investigational statement. Patient selection criteria added to the policy guidelines. FEP verbiage added to the Policy Exceptions section. Deleted outdated references in the Sources section.
04/18/2011: Policy description and statement unchanged. Removed deleted CPT code 63660 from the Code Reference section.
03/02/2012: Policy reviewed; no changes.
04/04/2013: Policy reviewed; no changes to policy statement. Added ICD-9 procedure code 86.05 to the Code Reference section.
04/22/2014: Policy statement updated to add "in all other situations including but not limited to" and "cancer-related pain" to the investigational policy statement.
12/31/2014: Code Reference section updated to revise the description of the following CPT code: 95972.
02/09/2015: Policy reviewed; description updated. Policy statement updated to add heart failure as investigational.
08/27/2015: Code Reference section updated for ICD-10. Removed deleted HCPCS codes E0752, E0754, E0756, E0757, and E0758.
12/31/2015: Policy guidelines updated to add medically necessary and investigative definitions. Code Reference section updated to revise the description for CPT code 95972.
05/31/2016: Policy number added.
07/20/2016: Policy description updated regarding devices. Policy statement updated to add "with standard (non-high-frequency) stimulation" to the medically necessary statement. Added statement that high-frequency spinal cord stimulation is investigational for the treatment of severe and chronic pain of the trunk or limbs.
09/30/2016: Code Reference section updated to add new ICD-10 procedure code 05P002Z.
Blue Cross & Blue Shield Association policy # 7.01.25
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.