Is implantation of neuroelectrodes (63650) medically necessary for a 70-year-old female patient with chronic low back and hip pain, who has tried conservative treatments including epidural steroid injections, radiofrequency (RF) ablation, physical therapy (PT), oxycodone, elavil (amitriptyline), voltaren (diclofenac), and lyrica (pregabalin) without significant benefit?

Medical Necessity Determination for Spinal Cord Stimulator Trial (CPT 63650)

Primary Recommendation

The requested spinal cord stimulator trial is NOT medically necessary at this time due to the absence of documented Oswestry Disability Index (ODI) score, which is a mandatory criterion per the insurance policy's clinical practice bulletin. The patient does not meet all required criteria despite otherwise appearing to be an appropriate candidate for neuromodulation.

Critical Missing Documentation

The ODI score ≥21% is explicitly required by the policy and is non-negotiable for approval. 1 The American Society of Anesthesiologists guidelines support using validated functional disability measures before proceeding with spinal cord stimulation. 1

• The policy specifically states: "Member's functional disability assessed using the Oswestry Disability Index (ODI); member has received an ODI score greater than or equal to 21%"
• Without this objective measure, medical necessity cannot be established regardless of subjective pain reports
• Additional information was requested but not provided, indicating incomplete evaluation

Clinical Context Analysis

Diagnostic Inconsistency

The clinical presentation suggests facet-mediated pain with excellent response to radiofrequency ablation (80-100% improvement), which contradicts the indication for spinal cord stimulation trial for "diabetic neuropathy." 1

• The patient achieved 90-100% improvement with bilateral lumbar RFA at L4-5-S1 for >6 months 1
• Multiple successful RFA procedures (2018-2025) with consistent 80-100% pain relief 1
• Recent SI joint RFA (January 2025) with 90% improvement 1
• This pattern indicates facet-mediated pain, not neuropathic pain requiring spinal cord stimulation 1

Indication Mismatch

The assessment lists "diabetic neuropathy" as the indication for spinal cord stimulation, but the clinical history describes bilateral low back and hip pain responding to facet interventions, not peripheral neuropathy. 1

• Spinal cord stimulation is indicated for chronic neuropathic pain including diabetic peripheral neuropathy when conservative treatments fail 1, 2, 3
• The patient's pain pattern (bilateral low back/hip worse on right with leg/foot pain) and excellent response to RFA suggests facet-mediated pain, not diabetic neuropathy 1
• No documentation of diabetic neuropathy diagnosis or failed conservative neuropathy treatments

Evidence-Based Concerns

Success of Current Treatment

The patient demonstrates excellent ongoing response to radiofrequency ablation, which provides moderate evidence for short-term (3-6 months) pain relief in facet-mediated chronic low-back pain. 1

• Most recent RFA (July 2025) achieved 100% improvement in pain and function 1
• This contradicts the claim that "conservative treatment not beneficial" 1
• Repeated RFA procedures are appropriate for facet-mediated pain with this response pattern 1

Spinal Cord Stimulation Evidence

Low to very low-certainty evidence suggests spinal cord stimulation may provide clinically important benefits when added to conventional medical management, but only for appropriate neuropathic pain conditions. 3

• SCS shows small effect versus placebo (mean difference -8.73 on 0-100 scale, below clinically important threshold of ≥10 points) at short-term follow-up 3
• Device-related complications include lead failure/displacement (0.9-14%), infection (3-7%), and reoperation/reimplantation (2-31%) at medium-term follow-up 3
• One study reported 55% lead failure and 94% reoperation rate at 5-year follow-up 3
• Serious adverse events include autonomic neuropathy, prolonged hospitalization, device extrusion, and death from subdural hematoma 3

Policy Compliance Assessment

Criteria Met

• Chronic pain >12 months duration (2 years) 1
• Multidisciplinary evaluation including psychological clearance by Dr. Victoria Christofi 1
• Conservative treatments attempted including medications (oxycodone, Elavil, Voltaren, Lyrica), PT, ESI, RFA 1
• No recent spinal surgery or >6 months post-operative 1

Critical Criterion NOT Met

• ODI score ≥21% not documented 1

Recommendation for Approval Pathway

To establish medical necessity, the following must be obtained:

1. Documented ODI score ≥21% - This is the single missing mandatory criterion 1

2. Clarification of primary diagnosis:

   • If diabetic neuropathy: Document failed conservative neuropathy treatments (gabapentin/pregabalin optimization, duloxetine, topical agents) 1
   • If facet-mediated pain: Explain why continued RFA (which shows 100% improvement) is inadequate 1

3. Justification for SCS given excellent RFA response:

   • Document why a patient achieving 100% improvement with RFA requires neuromodulation 1
   • Address whether decreasing duration of RFA benefit warrants SCS versus continued periodic RFA 1

Common Pitfalls

• Proceeding without objective functional disability measures leads to inappropriate patient selection 1
• Confusing facet-mediated pain (responding to RFA) with neuropathic pain (indication for SCS) results in poor outcomes 1
• Ignoring excellent response to less invasive interventions (RFA) in favor of permanent implantable devices increases complication risk without clear benefit 1, 3
• The 5.5% incidence of generator pocket pain, higher in females and workers' compensation cases, represents an additional complication risk 4