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

Medical Necessity Assessment for E0748 Osteogenic Stimulator

Medical necessity is NOT met for E0748 in this case based on the insurance policy criteria and current clinical evidence. While the patient underwent a three-level cervical fusion (C4-7) which technically meets the "multiple level fusion entailing 3 or more vertebrae" criterion, the evidence does not support routine use of bone growth stimulators for primary cervical fusions without additional high-risk factors 1.

Insurance Policy Analysis

The Aetna policy explicitly covers E0748 for spinal indications including:

• Multiple level fusion of 3+ vertebrae (which this C4-7 fusion meets) [@case documentation@]
• Grade II or worse spondylolisthesis (not present)
• One or more failed fusions (not present)

However, the diagnosis code Z98.1 (Arthrodesis Status) is problematic as noted by the nurse reviewer [@case documentation@].

Critical Evidence-Based Considerations

Lack of Support for Routine Primary Fusion Use

The most recent 2014 Journal of Neurosurgery guidelines explicitly state that current evidence does not support routine use of bone growth stimulators for primary spinal fusions 1. The guidelines note:

• Methodological flaws in existing studies prohibit strong recommendations 1
• No proven benefit on fusion rates or clinical outcomes in instrumented fusions with autograft 1
• The cost ($1,300-$5,000) cannot be justified without demonstrated benefit 2

Specific Indications Where Evidence Exists

The 2005 and 2014 guidelines recommend bone growth stimulators ONLY for high-risk patients, specifically 1:

• Previous failed fusions (pseudarthrosis)
• Grade II or greater spondylolisthesis
• Patients over 60 years undergoing noninstrumented fusion (weak evidence only) 1
• Multiple risk factors including obesity, extensive multilevel grafting needs 1

This Patient's Risk Profile

The 55-year-old female patient does NOT meet high-risk criteria:

• Primary fusion (not revision/failed fusion)
• Instrumented fusion with interbody cages and anterior plating
• No spondylolisthesis mentioned
• Age 55 (below the 60+ threshold where minimal evidence exists) 1
• Cervical location (most evidence pertains to lumbar spine) 1

Clinical Reasoning

Why Approval is Not Warranted

1. The surgery utilized optimal fusion techniques: anterior cervical discectomy and fusion with interbody devices, anterior plating, bone marrow aspirate, and allograft [@case documentation@]. These represent gold-standard approaches with high fusion rates without stimulation 2

2. Evidence shows no benefit in instrumented fusions: Multiple studies demonstrate that bone growth stimulators provide no additional benefit when modern instrumentation and autograft/bone marrow aspirate are used 1

3. The diagnosis code Z98.1 (Arthrodesis Status) is inappropriate: This code indicates a history of previous fusion, but the operative note describes a primary fusion procedure for cervical myelopathy [@case documentation@]. If this were truly a revision of failed fusion, that would change the assessment, but the documentation does not support this interpretation.

Common Pitfalls to Avoid

• Do not approve based solely on meeting the "3+ level" criterion without considering the complete clinical picture and evidence base 1
• Recognize that insurance coverage criteria may be broader than evidence-based indications - medical necessity requires both policy compliance AND clinical appropriateness 1
• The presence of bone marrow aspirate use indicates the surgeon already employed biological enhancement [@case documentation@], making additional electrical stimulation redundant 2

Recommendation

Deny medical necessity for E0748. The patient underwent a well-executed primary instrumented cervical fusion with biological enhancement (bone marrow aspirate and allograft) and lacks the high-risk features that would justify bone growth stimulator use according to current evidence 1, 2. The diagnosis code Z98.1 does not accurately reflect a failed prior fusion requiring revision, which would be the primary evidence-based indication for stimulator use 1.

If the surgeon believes this patient has specific high-risk factors not documented (smoking, osteoporosis, metabolic bone disease, immunosuppression), request additional clinical documentation to support medical necessity 1, 3.