Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Spinal cord stimulation (dorsal column) requires pre-authorization.

2)    Spinal cord stimulation is used to treat severe pain in the limbs and back that has not responded to all other forms of therapy.

1.    Dorsal column stimulators (DCS) are covered  with preauthorization for the management of members with chronic pain that has not responded to all other forms of therapy*** and is due to:

a)    Failed back surgery syndrome with low back pain and significant radicular pain (M96.1), or

b)    Complex regional pain syndrome (also known as reflex sympathetic dystrophy), (G90.50 – G90.59), or

c)    Inoperable chronic ischemic limb pain secondary to peripheral vascular disease (I70.221 – I70.229, I70.321 – I70.329, I70.421 – I70.429, I70.521 – I70.529, I70.621 – I70.629, I70.721 – I70.729), or

d)    Members with documented metastatic malignant disease, who have a life expectancy of at least six months, is covered when above criteria are met, (psychological testing would not be required)
AND the member meets all of the following criteria:

·         Member experienced significant pain reduction (50% or more) with a 3- to 7-day trial of percutaneous spinal stimulation.  (A trial of percutaneous spinal stimulation is considered medically necessary for members who meet the below-listed criteria, in order to predict whether a dorsal column stimulator will induce significant pain relief.), and

·         There is documented pathology, i.e., an objective basis for the pain complaint, and 

·         Other more conservative methods of pain management have been tried and failed, and 

·         Member does not have any untreated existing drug addiction problems (per American Society of Addiction Medicine (ASAM) guidelines), and 

·         Member has obtained psychiatric clearance, and 

·         Member has predominantly radiating extremity pain.

2.    Revision, replacement or removal of spinal cord stimulators and their components are covered services.  Replacement components require preauthorization.

3.    Neuromuscular stimulators are not addressed by this policy; see BI116.

*** “Lack of response to all other forms of therapy” should include the preferred non-pharmacologic treatment modalities, the preferred non-opioid pharmacologic interventions and clinically appropriate procedural interventions described in detail in BI566 (Opioid Therapy for Chronic Pain).  G Trial/failure of opioids is not a requirement for a dorsal column stimulator for pain.

Codes Used In This BI:

1)    DCS is considered experimental and investigational for the management of members with other chronic non-malignant pain (e.g., headache, cephalgia, occipital neuralgia, intercostal neuralgia, trigeminal neuralgia, phantom limb syndrome, inguinal pain, and post-herpetic neuralgia), or spasticity because its effectiveness for these indications has not been established.

2)    Cervical spinal cord stimulation for the treatment of members with cervical trauma, disc herniation, or failed cervical spine surgery syndrome, presenting with arm pain, neck pain, or Cervicogenic headache, is considered experimental and investigational because its effectiveness for these indications has not been established.

Spinal cord stimulation delivers low voltage electrical stimulation to the dorsal columns of the spinal cord to block the sensation of pain. Spinal cord stimulation devices consist of several components:

• The lead that delivers the electrical stimulation to the spinal cord;
• An extension wire that conducts the electrical stimulation from the power source to the lead, and
• 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 2 basic types of power source. In one type, the power source (battery) can be surgically implanted. In another 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.

There is sufficient evidence of the effectiveness of dorsal column stimulation in failed back surgery syndrome and complex regional pain syndrome. North et al (1991b) reviewed the long-term results of 50 patients with failed back surgery syndrome who had received implantable DCS.  Successful outcome, as judged by at least 50% sustained analgesia and patient satisfaction with the result, was recorded in 53% of patients at 2.2 years and 47% of patients at 5.0 years.  Eighty three percent of the subjects continued to use their stimulators at the 5-year follow-up.  At the time of follow-up, only 12% of patients were using analgesic medications with half of them at reduced dosage, compared with 74% before the commencement of DCS therapy.  Moreover, most patients reported an improvement in ability to perform daily activities.  In another report that examined 5-year follow-up in 102 patients with failed back surgery syndrome undergoing repeated operation, North et al (1991a) found that most of these patients reported no change in their abilities to carry out activities of daily living.

Bell et al (1997) as well as Devulder et al (1997) reported that spinal cord stimulation is cost-effective in treating patients with chronic failed back surgery syndrome.

Turner, et al. (2004) conducted a systematic review on the effectiveness of DCS in relieving pain and improving functioning for patients with failed back surgery syndrome (FBSS) and complex regional pain syndrome (CRPS).  These authors concluded with suggestions for methodologically stronger studies to provide more definitive data regarding the effectiveness of DCS in relieving pain and improving functioning, short-term and long-term, among patients with chronic pain syndromes.  Taylor, et al. (2005) assessed the safety and effectiveness of DCS for the treatment of chronic back and leg pain and FBSS and concluded that there is moderate evidence for the effectiveness of DSC for these indications.  Furthermore, a recent Cochrane review (Mailis-Gagnon, et al., 2004) concluded that although there is limited evidence in favor of DCS for FBSS and CRPS, more research is needed to confirm whether DCS is an effective treatment for certain types of chronic pain.  This is in agreement with the findings of a recent assessment on spinal cord stimulation for the management of neuropathic pain by the Ontario Ministry of Health and Long Term Care (2005).  This report stated that FBSS and CRPS are the two most common indications for DCS.  North, et al. (2005) also reported that DCS provided adequate pain relief in patients with FBSS with predominant low back pain and secondary radicular pain.  Harney, et al. (2005) stated that there is now a significant body of evidence to support the utilization of DCS in the management of CRPS.

1.     Kemler MA, De Vet HC, Barendse GA, et al. (2004) the effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years` follow-up of the randomized controlled trial. Annals Neurology 2004; 55(1):13-8.

2.     Kemler MA, De Vet HC, Barendse GA, et al. (2004) the effect of spinal cord stimulation in patients with chronic reflex sympathetic dystrophy: two years’ follow-up of the randomized controlled trial. Ann Neurol 2004; 55(1):13-8.

3.     Kemler MA, de Vet HC, et al. (2008) Effection of spinal cord stimulation for chronic complex regional pain syndrome Type I: five-year final follow-up of patients in a randomized controlled trial. J Neurosurg, 2008; 108:292-8.

4.     Klomp HM, Spincemaille GH, Steyerberg EW, et al.(1999) Spinal cord stimulation in critical limb ischemia: a randomized trial. Lancet 1999; 353(9158):1040-4.

5.     Lapenna E, Papati D, et al.(2006) Spinal cord stimulation for patients with refractory angina and previous coronary surgery. Ann Thor Surg, 2006; 82:1704-8.

6.     Mailis-Gagnon A, Furlan AD, Sandoval JA, et al.(2004) Spinal cord stimulation for chronic pain. The Cochrane Database Systematic Reviews, Issue 3, Art. No. CD003783.pub2; 2004.

7.     Meyerson BA. (2001) Neurosurgical approaches to pain treatment. Acta Anaesthesiol Scand 2001; 45:1108-13.

8.     North R, Shipley J, et al.(2007) Practice parameters for the use of spinal cord stimulation in the treatment of chronic neuropathic pain. Pain Med, 2007; 8:S200-S275.

9.     North RB, Calkins SK, Campbell DS, et al. (2003) Automated, patient-interactive, spinal cord stimulator adjustment: a randomized controlled trial. Neurosurgery 2003; 52(3):572-80.

10. North RB, et al. (1993) Sperm function assays and their predictive value for fertilization outcome in IVF therapy: a meta-analysis. Neurosurg 1993; 32:384-395.

11. North RB, Kidd DH, Lee MS et al. (1994) a prospective, randomized study of spinal cord stimulation versus reoperation for failed back surgery syndrome: initial results. Stereotact Funct Neurosurg 1994; 62(1-4):267-72.

12. The British Pain Society. (2005) Spinal cord stimulation for the management of chronic pain. Recommendations for best clinical practice. http://britishpainsociety.org, accessed Feb 2007.

13. Turner JA, Loeser JD, Bell KG.(1995) Spinal cord stimulation for chronic low back pain: a systematic literature synthesis. Neurosurgery 1995; 37(6):1088-96.

14. Ubbink DT, Vermeulen H. (2003) Spinal cord stimulation for non-reconsdtructable chronic critical leg ischemia. The Cochrane Database Systematic Reviews 2003, Issue 3, Art NO. CD004001.

15. Arkansas BlueCross BlueShield, Coverage Policy Manual; Spinal Cord Neurostimulation for Treatment of Intractable Pain.

Addendum:

Effective 01/01/2017: Removed the following codes from Codes Used in This BI section: 63661 – 63664, 63688. Codes no longer referenced in BI.