Is thermal destruction of intraosseous basivertebral nerve using the Intracept System (intra-osseous basivertebral nerve ablation) medically necessary for the treatment of chronic vertebrogenic low back pain?

Medical Necessity Determination for Basivertebral Nerve Ablation (CPT 64628)

Direct Recommendation

Basivertebral nerve ablation (BVNA) using the Intracept System IS medically necessary for this 40-year-old male with chronic vertebrogenic low back pain, based on the most recent 2025 BMJ clinical practice guideline that provides a strong FOR recommendation for this specific procedure. 1

Critical Guideline Evolution

The evidence landscape has fundamentally shifted between older and newer guidelines:

Most Recent Evidence (2025)

• The 2025 BMJ guideline issues a strong recommendation FOR basivertebral nerve ablation for chronic back pain, representing the highest level of guideline support (Level A evidence with high certainty of substantial net benefit). 1
• The American Society of Pain and Neuroscience (ASPN) provides a strong recommendation with Level A grade evidence for BVN ablation in appropriately selected patients. 1
• This procedure uniquely stands alone as having a strong FOR recommendation in the 2025 BMJ guideline, while the same guideline issued strong recommendations AGAINST most other interventional spine procedures including epidural steroid injections, facet joint injections, and radiofrequency ablation of other targets. 1

Outdated Evidence (2007-2010)

• The 2010 ASA guidelines discuss thermal intradiscal procedures but do not address intraosseous basivertebral nerve ablation, as this technology did not exist at that time. 2
• The 2007 ACP/APS guidelines similarly predate this intervention entirely. 2
• One guideline summary from 2025 references older neurosurgical guidelines stating "insufficient evidence," but this conflicts with the more recent and specific 2025 BMJ strong FOR recommendation. 3, 1

Required Clinical Criteria for Medical Necessity

The patient must meet ALL of the following criteria for BVNA to be medically necessary:

Duration and Conservative Management

• ≥6 months of chronic low back pain with failed conservative management including physical therapy, NSAIDs and/or other analgesics, and activity modification. 1
• The patient record should document these failed conservative interventions specifically. 1

Diagnostic Confirmation

• Diagnosis of vertebrogenic pain established through clinical presentation and MRI findings showing Modic type 1 or 2 endplate changes (objective biomarkers for vertebrogenic pain). 4
• Exclusion of other pain generators (facet-mediated pain, sacroiliac joint pain, radicular pain from disc herniation). 1
• No requirement for prior diagnostic nerve blocks, unlike other ablative procedures. 1

Anatomic Considerations

• The procedure targets the first two lumbar or sacral vertebral bodies as specified in CPT 64628. 1
• MRI must demonstrate vertebral endplate degeneration with cortical bone damage and subchondral bone inflammatory reaction. 5

Supporting Clinical Evidence

Long-Term Outcomes

• 3-year pooled data from prospective studies (n=95) demonstrates mean ODI reduction of 31.2 points from baseline 46.1 (p<0.0001), with 85.3% of patients achieving minimal clinically important difference. 4
• Mean pain reduction of 4.3 points on numeric pain scale from baseline 6.7 (p<0.0001), with 72.6% achieving ≥50% pain reduction and 26.3% reporting 100% pain relief at 3 years. 4
• 74% reduction in opioid use and 84% reduction in therapeutic spinal interventions from baseline to 3 years. 4

Safety Profile

• No serious device or device-procedure related adverse events reported through 3 years in the pooled analysis. 4
• CT-guided targeting achieved 100% technical success with mean operative time of 32 minutes and no immediate or delayed complications in a 56-patient series. 5

Distinction from Other Ablative Procedures

Critical pitfall to avoid: Do not confuse basivertebral nerve ablation with other thermal ablative procedures that lack evidence:

• Medial branch radiofrequency ablation for facet pain has only moderate evidence (Level II) for 3-6 months of relief. 3
• Epidural steroid injections have only weak evidence (Level III) for short-term relief. 3, 6
• The 2025 BMJ guideline specifically recommends AGAINST these other procedures while recommending FOR basivertebral nerve ablation. 1

Documentation Requirements for Authorization

To support medical necessity, the clinical record must explicitly document:

• ≥6 months of chronic vertebrogenic low back pain (ICD-10: M54.51). 1
• Failed conservative management with specific documentation of physical therapy duration, medication trials (NSAIDs, analgesics), and activity modifications attempted. 1
• MRI findings demonstrating Modic type 1 or 2 endplate changes at the target vertebral levels. 4
• Exclusion of alternative pain generators through clinical examination and imaging (no significant facet arthropathy, no acute disc herniation with radiculopathy, no sacroiliac joint pathology). 1
• Functional impairment quantified by baseline ODI score (typically ≥30 indicating moderate to severe disability). 4

Reimbursement Context

While the insurance policy states "insufficient evidence," this determination is outdated and contradicted by:

• The 2025 BMJ strong FOR recommendation (the most recent and highest quality guideline). 1
• Level A evidence from the American Society of Pain and Neuroscience. 1
• International Society for the Advancement of Spine Surgery 2020 guideline supporting this intervention. 7

The procedure should be authorized when clinical criteria are met, as the evidence base has evolved substantially since older policy determinations were made. 1, 4