Is permanent implantation of a neuro (nerve) spinal cord stimulator medically necessary for a patient with chronic low back pain and radiating bilateral leg pain and paresthesias, status post laminectomy and fusion and instrumentation?

Medical Necessity Determination for Permanent Spinal Cord Stimulator Implantation

Permanent spinal cord stimulator implantation is NOT medically necessary for this patient at this time due to incomplete documentation of mandatory prerequisite criteria, specifically the absence of documented psychological evaluation, formal physical therapy program, trials of first-line neuropathic pain medications, and baseline validated outcome measures required by the American Society of Anesthesiologists guidelines. 1

Critical Missing Documentation That Precludes Medical Necessity

Mandatory Psychological Evaluation

• The American Society of Anesthesiologists explicitly requires favorable psychological evaluation, absence of untreated psychiatric comorbidity, or current treatment in a multidisciplinary pain management program before SCS trial 1
• Psychological screening is essential for patient selection and predicting long-term success 2
• No documentation exists confirming psychological clearance, motivation, or capability to follow medical recommendations 3

Required Conservative Treatment Documentation

• No documentation of duration, specific medications tried, dosages, or compliance for conservative treatment, which is a mandatory criterion 1
• Trials of first-line neuropathic pain medications (gabapentinoids, tricyclic antidepressants, or SNRIs) must be documented before considering SCS 1
• The Mayo Clinic Proceedings specifically recommends documenting trials of gabapentin, pregabalin, duloxetine, or tricyclics before SCS 1
• Conventional medical management, including appropriate analgesics, must be tried before considering spinal cord stimulation 1

Formal Physical Therapy Requirements

• No evidence of structured physical therapy program, which is a required treatment before considering spinal cord stimulation 1
• Formal in-person physical therapy with a licensed physical therapist for a minimum of 6 weeks within the past year is required, with documentation including dates of service, specific interventions, patient response, and therapist assessment 3
• Physical therapy and conservative measures should be attempted before considering spinal cord stimulation 1

Baseline Outcome Measures

• No validated outcome measures (VAS or ODI) were documented at baseline, making it impossible to objectively measure trial success 1
• An Oswestry Disability Index (ODI) score of ≥21% is required to document functional disability and establish baseline functional status 3
• The ODI questionnaire must be administered and scored prior to implant 3

Safety Documentation

• No documentation excluding coagulopathy, anticoagulant/antiplatelet therapy, or thrombocytopenia, which is a critical safety requirement before any epidural procedure 1
• No documentation that the patient is capable of operating the stimulating device, which is essential for successful outcomes 1

Evidence-Based Treatment Sequence Not Followed

Alternative Interventions Not Documented

• The American Society of Anesthesiologists recommends considering pulsed radiofrequency treatment adjacent to the dorsal root ganglion before proceeding to SCS, but this was not documented 1
• For focal pain in limited dermatomes, spinal neurolytic blocks may be more appropriate than stimulation 1

Failed Back Surgery Syndrome Criteria

• Spinal cord stimulation is specifically recommended for therapy-resistant radicular pain in the context of Failed Back Surgery Syndrome 1
• The patient's diagnosis of persistent pain following multilevel lumbar fusion is an established indication for SCS 3
• However, the complete prerequisite documentation must be present before proceeding 1, 3

Clinical Evidence Supporting SCS When Criteria Are Met

Efficacy Data

• SCS demonstrates significant advantages over reoperation for persistent pain after back surgery, with 47-59% of FBSS patients achieving ≥50% pain relief at long-term follow-up 3
• A successful trial showing at least 50% pain relief is required before permanent implantation 3
• Real-world data shows 90.1% of patients have successful SCS evaluation, with 80.4% converting to permanent implant 4
• Overall conversion rate from SCS evaluation to permanent implant of 72.4% exceeds national rates of 64% 4

Trial Period Requirements

• The American College of Neurosurgery recommends SCS for patients with FBSS and chronic pain, with a successful trial showing at least 50% pain relief 3
• A successful trial with 70% pain relief is a strong positive predictor of long-term success, exceeding the standard 50% pain reduction threshold 3
• Careful patient selection including a rigorous trial period is essential 2

Hardware-Related Risks

Complication Rates

• Hardware-related complications, including lead migration and connection issues, occur in 10-29% of cases 1
• Infection risk must be carefully considered, with reported rates of 10-29% 1
• Wound dehiscence followed by infection occurs in 14% of cases 5
• Lead migration occurs in 9% of cases 5
• The potential need for revision surgery should be discussed with patients 1

Required Actions Before Approval

The following documentation must be obtained and submitted before medical necessity can be established:

• Formal psychological evaluation confirming absence of untreated psychiatric comorbidities, substance use disorders, and demonstrating patient motivation and capability 1, 3
• Documented trials of first-line neuropathic pain medications including specific medications, dosages, duration, and reasons for discontinuation (gabapentin, pregabalin, duloxetine, or tricyclic antidepressants) 1
• Formal physical therapy documentation including dates of service (minimum 6 weeks), specific interventions performed, patient response, and therapist assessment 1, 3
• Baseline validated outcome measures including Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) scores 1, 3
• Coagulation studies excluding coagulopathy, anticoagulant/antiplatelet therapy, or thrombocytopenia 1
• Documentation of patient capability to operate the stimulating device 1