Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Back pain
Treatment: Implantation of spinal cord stimulator
The insurer denied coverage for implantation of spinal cord stimulator.
The denial is overturned.

This is an adult patient with a history of chronic neuropathic pain secondary to type 2 diabetes mellitus. The patient has failed 5 years of conventional medical management with anticonvulsants, serotonin-norepinephrine reuptake inhibitors (SNRI) and tricyclic antidepressants, opioids, topicals, physical therapy, and transcutaneous electrical nerve stimulation (TENS). The patient underwent a Spinal Cord Stimulation (SCS) trial and reported more than 75% (percent) pain relief with improved activities of daily living (ADLs). The patient's pain returned when trial leads were removed. SCS implantation is being requested.

SCS may be considered for patients with chronic pain who have failed conservative approaches. The most common use of SCS placement is chronic pain from failed back surgery syndrome (FBSS), although SCS may be effective for pain from other etiologies. A 2019 meta-analysis of 12 randomized trials including approximately 1000 patients with intractable spine or limb pain related to various disorders (such as FBSS, chronic back, leg, or trunk pain, painful diabetic neuropathy [PDN], peripheral vascular disease, complex regional pain syndrome [CRPS]) found that SCS was associated with increased odds of > (greater than) 50% pain reduction, compared with continued medical therapy. Additional randomized controlled trials have also demonstrated that patients with refractory PDN experienced substantial pain relief and improved health-related quality of life sustained over 6 months when treated with 10-kilohertz (kHz) SCS.

The Centers for Medicare and Medicaid Services (CMS) guidelines (L36035) state that spinal cord (dorsal column) stimulation (SCS) is best suited for pain that is neuropathic in nature such as resulting from actual damage to the peripheral nerves. Common indications include, but are not limited to, failed back syndrome, complex regional pain syndrome (reflex sympathetic dystrophy), arachnoiditis, radiculopathies, phantom limb/stump pain, peripheral neuropathy. SCS is generally not effective in treating nociceptive pain (resulting from irritation, not damage to the nerves) and central deafferentation pain (related to central nervous system damage from a stroke or spinal cord injury). SCS is also Food and Drug Administration (FDA) approved for treatment of chronic pain in the trunk or limbs, including one-sided or two-sided pain associated with FBSS, intractable low back pain, leg pain, and pain associated with nerve damage caused by diabetes 

According to UpToDate, overall complications of SCS range from 5.3 to 40 percent and are most commonly due to hardware-related issues. The majority of complications are not life-threatening, such as lead migration, but they do often require lead revision or exploration. Spinal Epidural Hematoma (SEH) is a rare, potentially catastrophic complication of SCS.

In summary, based on current evidence for the treatment of PDN, CMS guidelines, FDA approval, and > 50% pain relief from the patient's SCS trial, it would be medically reasonable for this patient to undergo permanent SCS implantation. Current literature supports that SCS would be a safe and effective treatment option that could be easily reversed if needed, to treat this patient's medical condition. Thus, the SCS is considered medically necessary to treat this patient's painful diabetic neuropathy. 

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably, with sound medical judgment, or in the best interest of the patient. The medical necessity for implantation of spinal cord stimulator is substantiated.