CurrentCapital BluecrossPolicy MP 1.124

PERCUTANEOUS INTRADISCAL ELECTROTHERMAL ANNULOPLASTY, RADIOFREQUENCY ANNULOPLASTY, BIACUPLASTY AND INTRAOSSEOUS BASIVERTEBRAL NERVE ABLATION

This policy governs Capital BlueCross coverage determinations for percutaneous intradiscal electrothermal annuloplasty (including radiofrequency annuloplasty and biacuplasty) and intraosseous basivertebral nerve ablation for chronic low back pain, specifying investigational/not covered indications and program variations.

Policy Summary

PayerCapital Bluecross

PolicyPercutaneous intradiscal electrothermal annuloplasty, radiofrequency annuloplasty, biacuplasty and intraosseous basivertebral nerve ablation

Policy CodePolicy MP 1.124

Change TypeAdministrative — no material clinical changes

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionObtain benefit verification and prior authorization per member contract when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Investigationalcoverage stance — annuloplasty

Investigationalcoverage stance — basivertebral ablation

2 RCTsRCTs for intradiscal RF

SMART, INTRACEPTnamed RCTs

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Coverage Determinations

Investigational — Not covered

Coverage determination based on evidence review

Overall stance: Percutaneous annuloplasty procedures (intradiscal electrothermal annuloplasty, intradiscal radiofrequency annuloplasty, intradiscal biacuplasty) and intraosseous basivertebral nerve ablation are considered investigational due to insufficient evidence of net health benefit.

Supported by randomized trials with conflicting or insufficient results as summarized in the evidence review.

The randomized trials of intraosseous basivertebral nerve ablation include the SMART and INTRACEPT trials. In SMART, a high rate of crossover (73% at 12 months) prevents availability of long-term comparative data using intent-to-treat analyses. Although INTRACEPT reported short-term improvements versus standard care, substantial crossover in trials and limited long-term randomized comparative data mean the evidence is insufficient to conclude a durable net health benefit for basivertebral nerve ablation.

Radiofrequency ablation of the basivertebral nerve (for example, the Intracept® system) for treatment of vertebrogenic low back pain is considered investigational and is not covered. This policy notes that existing randomized trials (INTRACEPT and SMART) have methodological limitations, including high crossover rates, and that comparative evidence is insufficient to demonstrate improvement in net health outcomes.

Percutaneous annuloplasty procedures (including intradiscal electrothermal annuloplasty, intradiscal radiofrequency annuloplasty, and intradiscal biacuplasty) and intraosseous basivertebral nerve ablation are considered investigational. The policy finds insufficient evidence from randomized trials—some with conflicting results or high crossover—to support that these procedures provide a net health benefit for chronic discogenic or vertebrogenic low back pain; therefore they are not medically necessary/covered.

Procedure and Billing Codes

Investigational and therefore not coveredCPTNot Covered

22526	Procedure code listed as investigational
22527	Procedure code listed as investigational
64628	Procedure code listed as investigational
64629	Procedure code listed as investigational

Policy-coded procedure additionsCPT

64628	Code added to policy (document notes addition)
64629	Code added to policy (document notes addition)

Coding

CPT / Procedure codes (investigational)22526; 22527; 64628; 64629 (listed in policy as investigational and not covered)

Coding note — additionsCodes 64628 and 64629 were added to the policy effective 01/01/2022 per policy history

Coding guidanceCode list may not be all-inclusive; codes are subject to change and should be verified prior to claim submission

Provider Requirements and Administrative Notes

Prior Authorization

Benefit verification required

This policy is applicable only to certain programs and products administered by Capital BlueCross. Coverage and medical necessity determinations are subject to the member's specific benefit program and eligibility on the date of service. Providers should verify member benefits and eligibility prior to rendering services.

Verify member benefits and eligibility prior to providing services.
Coverage is subject to the terms of the member's benefit program and may vary by product.

Prior Authorization

Prior authorization and coding note

Prior authorization may be required depending on the member's benefit program. Providers should obtain prior authorization when applicable. Procedures described in this policy may be managed per the member’s benefit plan and coding reviews.

Prior authorization requirements vary by product and should be confirmed prior to scheduling.
Coding reviews and benefit plan rules may imply prior authorization — contact Capital BlueCross for plan-specific requirements.

Clinical Background

Electrothermal intradiscal annuloplasty techniques deliver thermal energy, typically via radiofrequency, to the annulus fibrosus with the intent to thermocoagulate nociceptors and alter annular tissue structure in patients with presumed discogenic low back pain. These minimally invasive techniques (including biacuplasty and radiofrequency annuloplasty) are proposed to reduce pain and improve function by targeting annular pain generators after conservative therapy has failed.

Key Terms and Device Definitions

Intervertebral disc

DefinitionIntervertebral disc: fibrocartilaginous tissue between the vertebral bodies; outer portion is the annulus fibrosus and inner portion is the nucleus pulposus.

FunctionActs as a shock absorber, permits movement between vertebral bodies.

Anatomic componentsAnnulus fibrosus (outer) and nucleus pulposus (inner).

Nociceptors

DefinitionNociceptors: free nerve endings that are receptors for painful stimuli.

Role in painTransmit pain signals in response to noxious mechanical, thermal, or chemical stimuli.

Location relevance

Conservative Therapy Prerequisites

Conservative therapy recommended prior to device use per background and device labeling — >= 6 months

Conservative therapy is expected prior to considering device-based intraosseous basivertebral nerve ablation per device labeling and policy background.

Conservative treatment duration: At least 6 months of conservative care (e.g., physical therapy, medication management) and chronic low back pain of at least 6 months' duration are recommended prior to consideration of intraosseous basivertebral nerve ablation (Intracept) per device FDA summaries and policy background.>= 6 months

FDA Intracept labeling specifies use for chronic low back pain of at least 6 months duration that has not responded to at least 6 months of conservative care.

Frequency and Repeat Treatment Limits

Frequency limits

Frequency limitsNo procedure-specific frequency limits stated in the policy.

Frequency periodNot applicable — policy does not define repeat interval or maximum number of procedures.

Provider actionVerify member benefit and prior authorization requirements per plan; clinical repetition rules follow benefit design.

Imaging and Diagnostic Requirements

Note

Intracept device labeling and MRI (Modic) context

For Intracept intraosseous basivertebral nerve ablation, FDA summaries note the device indication references chronic low back pain of at least 6 months duration and mention accompanying features consistent with Type 1 or Type 2 Modic changes on MRI.

Intracept intended for L3–S1 basivertebral nerve ablation for chronic low back pain ≥6 months not responsive to ≥6 months conservative care.
FDA summary describes accompanying MRI features consistent with Type 1 or Type 2 Modic changes.

Note

Imaging/diagnostic guidance referenced (NICE IPG545/IPG544)

National guidance documents (NICE IPG545 and IPG544) are referenced for percutaneous intradiscal radiofrequency and electrothermal treatments; imaging and diagnostic considerations in those guidelines may inform pre-procedure evaluation.

NICE IPG545: Percutaneous intradiscal radiofrequency treatment of the intervertebral disc nucleus (2016).
NICE IPG544: Percutaneous electrothermal treatment of the intervertebral disc annulus (2016).

Explicit Not Covered Procedures

Not covered procedures include percutaneous intradiscal electrothermal annuloplasty (intradiscal electrothermal annuloplasty), intradiscal radiofrequency annuloplasty, intradiscal biacuplasty, and intraosseous basivertebral nerve ablation (e.g., Intracept®). The policy states these interventions are investigational due to insufficient evidence of sustained benefit from the available randomized trials and are therefore not medically necessary/covered.