Is medical necessity met for an osteogenic stimulator (E0748) for a patient with a multiple-level spinal fusion, specifically C4-7 fusion, and a diagnosis of arthrodesis status?

Medical Necessity Assessment for E0748 Osteogenic Stimulator

Direct Answer

Medical necessity is NOT met for E0748 in this case, despite meeting the Aetna policy criterion for multilevel fusion (C4-7), because the patient underwent a well-executed primary instrumented cervical fusion with optimal biological enhancement and lacks the high-risk features that would justify bone growth stimulator use based on current evidence. 1

Analysis of Insurance Coverage Criteria

Aetna Policy Requirements Met

• The patient clearly meets criterion 2a: Multiple level fusion involving 3 or more vertebrae (C4-5, C5-6, C6-7) 1
• The surgical procedure documented includes anterior cervical discectomy and fusion at three levels, which technically satisfies the insurance policy language 1

Critical Problem with Diagnosis Code Z98.1

• Z98.1 (Arthrodesis Status) is problematic and does not accurately reflect the clinical scenario 1
• This code indicates a history of arthrodesis, not an acute surgical indication requiring bone growth stimulation 1
• The operative note clearly shows this was a primary fusion for cervical myelopathy with cord compression, not a revision or failed fusion 1

Evidence-Based Clinical Assessment

Why Bone Growth Stimulator is NOT Indicated

Optimal surgical technique was already employed:

• Anterior cervical stabilization with interbody devices (cages) at all three levels 1
• Anterior plating for rigid fixation 1
• Bone marrow aspirate from cervical vertebral body (biological enhancement) 1
• Morcelized allograft 1
• These represent gold-standard approaches with high fusion rates without additional stimulation 1

Evidence Against Use in This Population

Multiple studies demonstrate no benefit in instrumented fusions:

• Level II evidence shows bone growth stimulators provide no additional benefit when modern instrumentation and autograft/bone marrow aspirate are used 2, 1
• The Journal of Neurosurgery guidelines found that patients treated with direct current stimulation in instrumented PLF with autogenous bone graft showed no significant effect on either fusion rates or clinical outcomes 2
• Current evidence has methodological flaws that prohibit strong recommendations for routine use 2

High-Risk Features Required for Consideration

The American Academy of Neurosurgery recommends bone growth stimulators ONLY for:

• Previous failed fusions 1
• Grade II or greater spondylolisthesis 1
• Patients over 60 years undergoing noninstrumented fusion 2, 1
• Multiple risk factors including obesity and extensive multilevel grafting needs 2, 1

This patient has NONE of these high-risk features:

• Age 55 (not over 60) 1
• Primary fusion (not revision or failed fusion) 1
• Well-instrumented fusion (not noninstrumented) 1
• No documented spondylolisthesis 1
• No documented obesity or other high-risk factors 1

Cost-Effectiveness Considerations

Financial burden without demonstrated benefit:

• Bone growth stimulators cost $1,300-$5,000 1, 3
• No proven benefit on fusion rates or clinical outcomes in instrumented fusions with autograft has been demonstrated, making the cost unjustifiable 1
• In today's medical climate, costs associated with interventions lacking definitive benefit cannot be ignored 2

Common Pitfalls to Avoid

Meeting insurance policy criteria does not equal medical necessity:

• While the multilevel fusion criterion is technically met, evidence-based medicine requires consideration of whether the intervention provides actual clinical benefit 1
• The diagnosis code Z98.1 creates confusion by suggesting a history of arthrodesis rather than the actual clinical scenario of primary fusion for myelopathy 1

Distinction between policy coverage and clinical appropriateness:

• Insurance policies may cover interventions in broader populations than evidence supports 1
• Clinical judgment must prioritize interventions with demonstrated impact on morbidity, mortality, and quality of life 2, 1

Recommendation

Deny medical necessity for E0748 based on:

1. Primary instrumented cervical fusion with optimal biological enhancement already performed 1
2. Absence of high-risk features that would justify bone growth stimulator use according to current evidence 2, 1
3. Level II evidence showing no benefit in instrumented fusions 2, 1
4. Inappropriate diagnosis code (Z98.1) that does not reflect the actual clinical scenario 1