CurrentCareSourcePolicy N/A

Intraosseous Basivertebral Nerve Ablation (Intracept) — Coverage Criteria

Coverage policy for intraosseous basivertebral nerve ablation (e.g., Intracept) to treat vertebrogenic chronic low back pain; governs medical necessity criteria and exclusions for members in the referenced payer program (Arkansas PASSE).

Policy Summary

PayerCareSource

PolicyIntraosseous Basivertebral Nerve Ablation (Intracept) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and document ≥6 months of chronic low back pain, MRI with Modic type I or II at L3–S1, and at least 6 weeks each of active and inactive conservative therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsminimum chronic low back pain duration required

6 weeksactive conservative therapy minimum

6 weeksinactive conservative therapy minimum

L3–S1Modic levels required

K222281example FDA clearance

Coverage and Medical Necessity Criteria

Initial therapy (medical necessity criteria)

Covered when ALL of the following are met:

Primary clinical criteria: Member has chronic low back pain of at least 6 months duration>= 6 months

See documentation requirement for source of duration

Conservative therapy failure: Failure of conservative therapy as evidenced by ALL of: documentation of at least 6 weeks of inactive conservative therapy within the past 6 months; documentation of at least 6 weeks of active conservative therapy within the past 6 months OR documented inability to complete active therapy due to contraindication, increased pain, or intolerance6 weeks each within past 6 months

Active/inactive therapies defined in Definitions section (HEP, TENS, pharmacotherapy, devices)

Policy Summary

PayerCareSource

PolicyIntraosseous Basivertebral Nerve Ablation (Intracept) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and document ≥6 months of chronic low back pain, MRI with Modic type I or II at L3–S1, and at least 6 weeks each of active and inactive conservative therapy.

SourceLink

On This Page

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Imaging requirement: MRI demonstrates Type I or Type II Modic changes at one or more vertebral endplates from level L3 to S1Modic Type I or II at L3-S1

Type I: T1 hypointense & T2 hyperintense (bone marrow edema/inflammation); Type II: T1 hyperintense & T2 hyperintense (fatty marrow change)

Device approval: Device used is FDA-approved (eg, Intracept System)FDA 510(k)

Example 510(k): Intracept System

Contraindications

Not covered/Not medically necessary when any of the following contraindications exist:

Contraindications: Member has any of the listed contraindications: targeted ablation zone less than 10 mm from a sensitive structure not intended to be ablated (including vertebral foramen); current pregnancy; active systemic infection or localized infection in the area to be treated; skeletal immaturity; implantable pulse generator (eg, pacemaker, defibrillator) or other electronic implant; scoliosis; spinal instability

Contraindication list as enumerated in policy

Other coverage limits

Repeat procedure: Repeat or additional intraosseous basivertebral nerve ablation is not considered medically necessary

Not adequately studied in peer-reviewed literature

Anesthesia: Monitored anesthesia and conscious sedation during the procedure are considered not medically necessary and will not be reimbursed

Intraosseous basivertebral nerve ablation is covered only when the member meets all specified medical necessity criteria. For any indication that does not meet the criteria listed in this policy, intraosseous basivertebral nerve ablation is considered not medically necessary and therefore not covered.

Repeat or additional intraosseous basivertebral nerve ablation procedures are not considered medically necessary and will not be covered because they have not been adequately studied in the peer‑reviewed medical literature. In addition, monitored anesthesia and conscious sedation during the procedure are considered not medically necessary and will not be reimbursed.

Required Conservative Treatment Before Approval

Documented failure of conservative therapy prior to approval

Documented failure of conservative therapy prior to approval — each therapy type must meet the specified duration within the prior 6 months:

Inactive conservative therapy: Documentation in the medical record of at least 6 weeks of inactive conservative therapy within the past 6 months (eg, devices, TENS, pharmacotherapy)>= 6 weeks within past 6 months

TENS use, device use, and pharmacotherapy must have documented use, frequency, duration, and start dates to be considered

Active conservative therapy: Documentation in the medical record of at least 6 weeks of active conservative therapy within the past 6 months (eg, physical therapy, occupational therapy, supervised home exercise program [HEP]) OR documentation of inability to complete active therapy due to contraindication, increased pain, or intolerance>= 6 weeks within past 6 months

HEP defined as a 6-week program requiring an exercise prescription/plan and follow-up documentation after completion, or documentation of inability to complete for valid physical reasons

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for intraosseous basivertebral nerve ablation and coverage is limited to members who meet ALL listed clinical criteria. The device used must be FDA-approved (for example, the Intracept System). Requests that do not meet all medical necessity criteria (including pain duration, conservative therapy requirements, and MRI findings showing Modic changes) should be denied.

Effective Date: 2024-05-01
Required device example: Intracept System (FDA 510(k) K222281)
Denial risk if ALL criteria not met

Documentation Required

Conservative Therapy Requirement

Approval requires documentation of failure of conservative therapy. The medical record must show at least 6 weeks of inactive conservative therapy within the past 6 months AND at least 6 weeks of active conservative therapy within the past 6 months, or documentation of inability to complete active therapy due to contraindication, increased pain, or intolerance. Definitions: HEP = 6-week home exercise program with documented exercise prescription and follow-up; TENS use, pharmacotherapy, and other passive modalities may be considered inactive conservative therapies when documented (use, frequency, duration, and start dates must be recorded).

At least 6 weeks inactive conservative therapy within past 6 months
At least 6 weeks active conservative therapy within past 6 months OR documented inability to complete active therapy
HEP must include exercise prescription and follow-up documentation; inability to complete must have medical reason (not patient inconvenience/noncompliance)
TENS use and dates must be documented to count as conservative therapy

Documentation Required

Required Documentation

The medical record must document chronic low back pain of at least 6 months' duration, details of the active and inactive conservative care (including HEP, therapy types, start and end dates, responses, and reasons for intolerance if applicable), and MRI findings demonstrating Modic Type 1 or Type 2 changes at one or more vertebral endplates from L3 to S1. The device must be FDA-approved and contraindications must be absent (for example, pregnancy, active infection, implantable electronic device, spinal instability, or targeted ablation zone too close to sensitive structures).

Chronic low back pain >= 6 months documented
MRI demonstrating Modic Type 1 or Type 2 changes at L3–S1
Documentation of conservative therapies with dates and follow-up
Documented absence of contraindications (see policy contraindication list)

Denial Risk

Denial for Not Meeting Criteria

Requests that do not meet ALL medical necessity criteria — including required pain duration, conservative therapy documentation, MRI-confirmed Modic changes, FDA-approved device use, and absence of listed contraindications — should be denied.

Denial recommended when any required criterion is missing
Repeat or additional intraosseous basivertebral nerve ablation is not considered medically necessary

Imaging and Diagnostic Findings Required

Note

MRI with Modic Type I or II changes required

MRI demonstrating Modic Type I or Type II changes at one or more vertebral endplates between L3 and S1 is required to support medical necessity for intraosseous basivertebral nerve ablation.

Type I: T1 hypointense and T2 hyperintense (bone marrow edema/inflammation)
Type II: T1 hyperintense and T2 hyperintense (fatty marrow/ischemia)

Regulatory and Coding References

FDA 510(k) referencesmixed

K222281	U.S. FDA 510(k) Premarket Notification: Intracept Intraosseous Nerve Ablation System
K171143	U.S. FDA 510(k) Premarket Notification: Relievant Medsystems RF Generator

Procedure Frequency and Repeat Procedure Limits

Intraosseous basivertebral nerve ablation — Repeat procedures not covered

Coverage stanceRepeat or additional intraosseous basivertebral nerve ablation is not considered medically necessary and is not covered

RationaleNot adequately studied in peer-reviewed medical literature (policy statement)

Reimbursement impactRepeat procedures will not be reimbursed

Key Definitions

Chronic Low Back Pain — definition

DefinitionPersistent lumbar region pain lasting more than 12 weeks

Policy minimum duration for coverageMember must have chronic low back pain of at least 6 months duration to meet medical necessity criteria

ContextChronic low back pain may be vertebrogenic and related to endplate degeneration (see imaging requirements for Modic changes)

HEP (Home Exercise Program) — definition and documentation requirements

Program lengthA 6-week exercise program

Documentation requiredExercise prescription/plan and follow‑up documented in the medical record after completion, or documentation of inability to complete HEP for a stated physical reason (eg, increased pain, inability to perform exercises)

Non-qualifying reasonsPatient inconvenience or unexplained noncompliance does not constitute inability to complete the HEP

Modic Changes (Type I and II) — MRI signal definitions

General definitionVertebral bone marrow signal intensity changes observable on MRI associated with degenerative disc disease

Modic Type IT1-weighted: hypointense; T2-weighted: hyperintense (bone marrow edema/inflammation)

Modic Type IIT1-weighted: hyperintense; T2-weighted: hyperintense (fatty marrow replacement/ischemia)

Clinical Background and Rationale

Chronic low back pain (CLBP) is a common condition that can be vertebrogenic when pain originates from degenerative changes of the vertebral endplates. These endplate changes are visible on MRI as Modic changes (Type I or II), which reflect bone marrow edema/inflammation (Type I) or fatty marrow replacement/ischemia (Type II). The basivertebral nerve innervates the vertebral endplates; targeted radiofrequency ablation of this nerve (intraosseous basivertebral nerve ablation, e.g., the Intracept system) is a minimally invasive percutaneous procedure intended to interrupt pain signaling from affected endplates and may be considered when the policy’s clinical criteria are met.

Services Not Covered

The following are not covered under this policy: repeat or additional intraosseous basivertebral nerve ablation (not considered medically necessary due to insufficient peer‑reviewed evidence) and monitored anesthesia and conscious sedation provided during the intraosseous basivertebral nerve ablation procedure (these services are not medically necessary and will not be reimbursed).