Is the Intracept (intraosseous basivertebral nerve ablation) procedure medically necessary for the treatment of chronic vertebrogenic low back pain?

Medical Necessity Determination for Intraosseous Basivertebral Nerve Ablation (Intracept)

Based on the most recent and highest quality evidence, intraosseous basivertebral nerve ablation (Intracept procedure, CPT 64628) is NOT medically necessary for this patient with chronic vertebrogenic low back pain, as current neurosurgical guidelines explicitly classify this procedure as having "insufficient evidence" for effectiveness. 1

Guideline-Based Recommendation

The 2025 BMJ clinical practice guideline—the most recent and authoritative evidence available—does not specifically address basivertebral nerve ablation among the 13 interventional procedures evaluated for chronic spine pain, which itself is telling about the procedure's lack of established evidence base. 2 This guideline issued strong recommendations AGAINST most interventional procedures for chronic axial spine pain, including nerve ablation procedures, epidural injections, and joint-targeted injections, finding no high certainty evidence of important pain relief for any intervention. 2

Key Guideline Findings:

• Current neurosurgical practice guidelines explicitly state there is "insufficient evidence" for the Intracept System (intraosseous basivertebral nerve ablation) for treatment of low back pain. 1

• The 2014 Journal of Neurosurgery guidelines for fusion procedures in degenerative lumbar disease do not include basivertebral nerve ablation as a recommended treatment option. 2, 1

• Even established interventional procedures with longer track records have limited evidence: epidural steroid injections have only weak evidence (Level III) for short-term relief, and facet medial nerve ablation has only moderate evidence (Level II) for 3-6 month pain reduction. 1

Evidence Quality Assessment

Why This Procedure Lacks Medical Necessity:

1. Absence from Evidence-Based Guidelines:

• The procedure is conspicuously absent from the comprehensive 2025 BMJ guideline that evaluated interventional procedures for chronic spine pain, suggesting insufficient evidence for inclusion even in systematic reviews. 2

2. Explicit "Insufficient Evidence" Classification:

• Neurosurgical guidelines specifically classify basivertebral nerve ablation as having "insufficient evidence" for effectiveness. 1

3. Unfavorable Cost-Benefit Ratio:

• Interventional procedures cost up to $5,000 per procedure in the US, with uncertain benefits and potential risks including prolonged pain/stiffness (8.6%), temporary altered consciousness (2.1%), dural puncture (1.4%), and deep infection (0.7%). 1
• Very small risk of catastrophic harms including infection resulting in meningitis, spinal cord injury, and paraplegia exists with spinal interventional procedures. 1

Research Evidence Limitations

While some research studies show potential benefit, they have critical limitations that prevent establishing medical necessity:

Study Design Flaws:

• The available research consists primarily of small studies without long-term follow-up, as noted in both prior denial reviews. 3, 4, 5, 6

• A 2022 scoping review identified multiple critical limitations: very specific patient populations studied, lack of true control groups due to high crossover rates, limited high-level or long-term studies, and predominantly industry-funded research. 4

• The most cited study (Khalil et al. 2019, Spine Journal) referenced in prior denials represents the best available evidence but remains insufficient to establish medical necessity given guideline standards. 4

Population Specificity:

• Studies typically include only highly selected patients with Modic type 1 or 2 endplate changes, leaving many chronic low back pain patients ineligible. 4, 5
• The association between Modic changes and low back pain requires additional research to gain widespread acceptance. 4

Clinical Context for This Patient

This 55-year-old patient presents with:

• Chronic low back pain (70% back, 30% leg pain)
• Type 1 Modic changes at L4-5 and L1-2
• Failed conservative management (PT, massage, NSAIDs)
• Multilevel degenerative disease with endplate edema

Despite meeting proposed selection criteria from research studies, the procedure remains non-covered because:

1. Guidelines do not support interventional procedures for chronic axial spine pain, even in well-selected patients. 2

2. The 2025 BMJ guideline found moderate certainty evidence that epidural injections and joint-targeted injections probably have little to no effect on pain relief for chronic axial spine pain, and it is unlikely new information will change these estimates. 2

3. Alternative established interventions (epidural injections, facet injections, trigger point injections) are also not recommended for long-term relief in current guidelines, further supporting conservative management as the appropriate standard of care. 1

Comparison to Established Alternatives

The American Academy of Neurosurgery indicates that lumbar epidural injections, facet injections, or trigger point injections may provide temporary symptomatic relief in selected patients, but these are not recommended for long-term relief. 1 If these more established procedures with longer safety records lack sufficient evidence for long-term benefit, a newer procedure with even less evidence cannot be considered medically necessary. 1

Common Pitfalls to Avoid

Do not confuse:

• Industry-sponsored medical society endorsements (NASS, ASPN, ISASS mentioned in appeal) with evidence-based clinical practice guidelines 2
• FDA approval or CPT code existence with medical necessity determination 1
• Positive Medicare coverage in some regions with established medical necessity 1
• Small case series or industry-funded studies with high-quality independent evidence 4

The 2025 BMJ guideline specifically noted that consensus-based guidelines (like those from interventional pain societies) are more likely to violate principles of evidence-based medicine than evidence-based guidelines, and rarely involve patient partners or describe explicit processes to evaluate certainty of evidence. 2

Recommendation

The second-level appeal should be DENIED based on insufficient evidence for medical necessity. 1 The patient should be counseled that:

• Current best evidence does not support interventional procedures for chronic axial spine pain 2
• Conservative management remains the evidence-based standard of care 2
• The procedure's long-term efficacy, safety profile, and superiority to conservative management remain unestablished in high-quality independent studies 1, 4