CurrentCapital BluecrossPolicy MP 1.124

Intraosseous Basivertebral Nerve Ablation

This policy governs coverage for intraosseous radiofrequency ablation of the basivertebral nerve (e.g., Intracept®) for treatment of vertebrogenic/chronic low back pain for members of Capital BlueCross products where the policy applies.

Policy Summary

PayerCapital Bluecross

PolicyIntraosseous Basivertebral Nerve Ablation

Policy CodePolicy MP 1.124

Change TypeNo material changes

Effective DateJun 1, 2026

Next Review Date

Key ActionClaims for intraosseous basivertebral nerve ablation (procedure codes 64628, 64629) are investigational and are subject to denial.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

InvestigationalCoverage stance

2 RCTsRCTs cited

64628,64629Procedure codes

K170827,K213836FDA device K#s

Coverage Determination

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Investigational determination: Intraosseous radiofrequency ablation of the basivertebral nerve (e.g., Intracept® system) for the treatment of vertebrogenic back pain is considered investigational and not covered.

There is insufficient evidence to determine improvement in net health outcome; randomized trials had limitations including high crossover rates, inconsistent results between intent-to-treat and per‑protocol analyses, lack of long‑term comparative data, and other design limitations (see Summary of Evidence).

Intraosseous radiofrequency ablation of the basivertebral nerve (e.g., Intracept® system) is considered investigational and is not covered. This policy lists the procedure codes 64628 and 64629 as investigational and not covered. The determination reflects insufficient evidence to conclude that intraosseous basivertebral nerve ablation improves net health outcomes.

The available evidence is inadequate to support coverage. Two randomized controlled trials (SMART and INTRACEPT) have been reported, but both have important limitations. SMART did not show a between-group difference in Oswestry Disability Index at 3 months on intent-to-treat analysis and had high crossover (73%) by 12 months, precluding long-term comparative assessment. INTRACEPT showed early benefit versus usual care but lacked a sham control and experienced very high crossover (92%) from the control arm, so comparative outcomes beyond 6 months are not available. Because of these trial limitations and lack of long-term comparative data, the evidence is insufficient to determine an improvement in net health outcome.

Procedural and Device Coding

Investigational and therefore not coveredCPTNot Covered

64628	Procedure code listed in policy as investigational / not covered
64629	Procedure code listed in policy as investigational / not covered

Regulatory / device codemixed

GXI	FDA product code for Intracept Intraosseous Nerve Ablation System
K170827	FDA 510(k) substantially equivalent designation (Intracept device, August 2017)
K213836	FDA 510(k) substantially equivalent designation (Intracept device, March 2022)

Provider Notice and Billing Guidance

Prior Authorization

Product/benefit variation and prior authorization

This policy applies only to certain Capital BlueCross programs and products and is subject to benefit variation; prior authorization requirements depend on the member's specific product and benefits. Check the member's plan and benefit documents for prior authorization requirements and any program-specific rules (for example, FEP members should refer to the FEP medical policy manual).

Documentation Required

Documentation and coding note

Submit claim documentation as you normally would; inclusion of a procedure code in the policy does not indicate coverage. When billing for procedures related to basivertebral nerve ablation, include applicable operative and device documentation, but note that the policy lists the procedure codes as investigational and not covered.

Denial Risk

Investigational — not covered (codes 64628, 64629)

Claims for intraosseous basivertebral nerve ablation using procedure codes 64628 and 64629 are considered investigational and therefore not covered; such claims are subject to denial.

Procedure codes listed as investigational/not covered: 64628, 64629

Clinical Background

Vertebrogenic (discogenic/endplate) low back pain is proposed to arise from damage to the vertebral endplates with nociceptive input transmitted via the basivertebral nerve, which enters the posterior vertebral body and sends branches to adjacent endplates. Conservative management such as physical therapy and medication management is typical initial care; intraosseous radiofrequency ablation targets basivertebral nerve branches within the posterior vertebral body with the aim of reducing chronic low back pain.

Key Definitions

Basivertebral nerve / vertebrogenic pain — key definitions

Anatomical originThe basivertebral nerve enters the posterior vertebral body and sends branches to the superior and inferior endplates.

Innervation targetBranches supply adjacent vertebral endplates (superior and inferior), conveying sensory signals from the endplate region.

Clinical concept — vertebrogenic painVertebrogenic pain is pain transmitted via the basivertebral nerve and is associated with endplate damage or degeneration.

Pathophysiology implicationEndplate damage or degeneration can activate intraosseous nerve branches within the vertebral body, producing lower back pain.

Annular lamellae / intervertebral disc / nociceptors — key definitions

Annular lamellaeCircular plates of collagen fibers found in secondary (mature, adult) bone.

Intervertebral discFibrocartilaginous tissue between vertebral bodies; outer portion is the annulus fibrosus and inner portion is the nucleus pulposus; functions as shock absorber and permits movement.

NociceptorsFree nerve endings that serve as receptors for painful stimuli.

Conservative Therapy and Prior Care

Conservative Care Duration Referenced in Device Labeling (Not Adopted as Coverage Criterion)

Device labeling and FDA 510(k) summaries reference a requirement for prior conservative therapy duration; this labeling information is described for context but is not adopted as a coverage requirement in this policy.

Labeling reference (not a coverage criterion): Device regulatory labeling for the Intracept Intraosseous Nerve Ablation System references treatment of chronic low back pain of at least 6 months duration that has not responded to at least 6 months of conservative care.>= 6 months

Policy states this duration is described in the FDA 510(k) summary but the policy determination remains investigational and the 6‑month conservative care duration is not adopted as an approved coverage criterion.

Imaging Findings

Note

MRI (Modic) findings described in device labeling — informational

The device labeling for the Intracept system describes MRI findings (Type 1 or Type 2 Modic changes) in the intended use and 510(k) summary, but this policy does not adopt those MRI features as coverage criteria.

FDA 510(k) summaries describe features consistent with Modic Type 1 or Type 2 changes (inflammation/edema, endplate changes, marrow signal changes).
Policy determination remains investigational despite device labeling references to MRI findings.