Spinal Cord Stimulation Trial is NOT Medically Necessary for This Patient
Based on the Aetna Clinical Policy Bulletin criteria and American Society of Regional Anesthesia and Pain Medicine guidelines, this patient does not meet the mandatory prerequisites for spinal cord stimulation trial and should be denied coverage. 1, 2
Critical Missing Documentation That Precludes Authorization
Multidisciplinary Team Evaluation - NOT MET
- No documentation exists of evaluation by a multidisciplinary team prior to implantation, which is an absolute requirement per Aetna criteria 5a 1
- The American Society of Regional Anesthesia and Pain Medicine requires comprehensive screening before SCS trial, which must include coordinated assessment by pain medicine, psychology, and physical therapy specialists 2
Mental Health Clearance - NOT MET
- No documentation of clearance from psychiatrist, psychologist, or qualified mental health professional (Aetna criterion 5c) 1
- While referral to psychologist for "SCS clearance" is noted on page 6, there is no documentation of the psychologist's recommendation or formal clearance 1
- The American Society of Regional Anesthesia and Pain Medicine mandates that all patients must be screened with an objective validated instrument for psychosocial factors, including depression (Grade B recommendation) 2
- The American Society of Anesthesiologists explicitly requires favorable psychological evaluation and absence of untreated psychiatric comorbidity before SCS trial 1
Conservative Treatment Duration - INSUFFICIENT DOCUMENTATION
- Physical therapy documentation shows last visit 08/2025 with 7 visits total, but no clear evidence this meets the mandatory 6-week minimum formal in-person PT within the past year (Aetna criterion 5d) 1
- No documentation of duration, specific medications tried, dosages, or compliance for conservative treatment 1
- No evidence of trials with first-line neuropathic pain medications such as gabapentinoids (gabapentin, pregabalin), tricyclic antidepressants, or SNRIs (duloxetine), which are required before considering SCS per Mayo Clinic recommendations 1
- Past NSAIDs/Acetaminophen shows only "Tylenol noted" with no duration documented 1
- The American Society of Regional Anesthesia and Pain Medicine emphasizes that a minimum of 6 months of documented conservative treatment, including physical therapy, medication trials, and interventional procedures, is required before SCS trial consideration 3
Functional Assessment - NOT DOCUMENTED
- No Oswestry Disability Index (ODI) score documented, despite Aetna requirement that member must have ODI score ≥21% (criterion 5f) 1
- Page 5 notes "leg weakness and inability to function due to pain" but provides no validated outcome measure 1
- Validated outcome measures such as VAS or ODI must be documented at baseline to objectively measure trial success 1
Substance Use Disorder Assessment - UNCLEAR
- Page 7 states "Opioid risk level reviewed today; patient's risk level is reasonable" but this does not constitute clear documentation of absence of untreated substance use disorder per ASAM guidelines (Aetna criterion 5b) 1
- The diagnosis code F11.20 (Opioid dependence) is listed, which raises concern about whether this represents treated or untreated dependence 1
Questionable Clinical Indication
Anatomical Mismatch Between Imaging and Diagnosis
- Lumbar MRI shows "widely patent" spinal canal at all levels with "no evidence of any neural impingement", which contradicts the diagnosis of lumbar radiculopathy requiring neuromodulation 1
- The L5-S1 degenerative changes described do not correlate with documented neural compression 1
- Spinal cord stimulation is specifically recommended for therapy-resistant radicular pain in the context of Failed Back Surgery Syndrome, but this patient does not have documented failed back surgery syndrome 1
Wrong Surgical History for FBSS Diagnosis
- The pain began after right hip replacement surgery (page 4), not after spinal surgery 1
- Aetna criterion 1 defines FBSS as "lumbar spinal pain of unknown origin either persisting despite surgical intervention or appearing after surgical intervention for spinal pain originally in the same topographical location" - hip replacement does not qualify 1
- The indication appears more appropriate for continued cervical-focused interventions rather than lumbar SCS trial, based on the patient's cervical MRI and response to cervical selective nerve root block 1
Evidence-Based Treatment Sequence Not Followed
Missing Intermediate Interventions
- 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
- Given 90% prior response to bilateral L4-5, L5-S1 RFA, repeat RFA should be considered with documentation of duration of relief and functional improvement before escalating to SCS 3
- Formal physical therapy program and medication optimization should be completed before SCS trial consideration 3
Safety Concerns Not Addressed
- 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
- Hardware-related complications, including lead migration and connection issues, occur in 10-29% of cases, and infection risk must be carefully considered 1
Current Evidence on SCS Efficacy
Limited Long-Term Benefit for Low Back Pain
- A 2023 Cochrane review found moderate-certainty evidence that SCS probably does not improve back or leg pain, function, or quality of life compared with placebo at 6 months 4
- At 6 months with placebo, pain was 61 points (0-100 scale), and only 4 points better with SCS (95% CI: 8.2 better to 0.2 worse) 4
- Function was 35.4 points (0-100 scale) with placebo, and only 1.3 points better with SCS (95% CI: 3.9 better to 1.3 worse) 4
- The Cochrane review concluded that "data do not support the use of SCS to manage low back pain outside a clinical trial" and that "current evidence suggests SCS probably does not have sustained clinical benefits that would outweigh the costs and risks of this surgical intervention" 4
Surgical Risks
- In one study, 31% of patients receiving SCS required revision surgery at 24 months 4
- Serious adverse events include infections, neurological damage, and lead migration requiring repeated surgery 4
- One study found 18% experienced adverse events and 8% required revision surgery 4
Recommendation
This spinal cord stimulation trial should be DENIED as not medically necessary. The patient fails to meet multiple mandatory Aetna criteria, including:
- Absence of multidisciplinary team evaluation (criterion 5a)
- Absence of mental health clearance (criterion 5c)
- Insufficient documentation of conservative treatment duration and medication trials (criterion 5d)
- Absence of ODI score (criterion 5f)
- Questionable diagnosis (criterion 1 - FBSS requires failed back surgery, not hip surgery)
Before reconsidering SCS trial, the following must be completed and documented:
- Formal multidisciplinary team evaluation including pain medicine, psychology, and physical therapy 2
- Formal psychological clearance with validated screening instrument for depression and other psychosocial factors 2
- Minimum 6 weeks of formal in-person physical therapy within the past year 1, 3
- Documented trials of first-line neuropathic pain medications (gabapentin/pregabalin, duloxetine, tricyclic antidepressants) with specific medications, dosages, durations, and reasons for discontinuation 1
- Baseline ODI score ≥21% 1
- Coagulation studies and documentation of anticoagulation status 1
- Consideration of repeat bilateral L4-5, L5-S1 RFA given 90% prior response 3
- Clear documentation addressing opioid dependence diagnosis (F11.20) and whether this represents treated or untreated substance use disorder per ASAM guidelines 1