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    v1.0.28
    OpenPayerPolicy UpdatesOrthopedics/MusculoskeletalBlue Cross Blue Shield - Kansas interspinous space…
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    Currentblue cross blue shield - kansasPolicy N/A

    Interspinous and Interlaminar Stabilization / Distraction Devices (Spacers)

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    This policy governs coverage determinations for interspinous and interlaminar spacer devices used to treat lumbar spinal stenosis, including as stand-alone implants or when used following decompression surgery, for Blue Cross and Blue Shield of Kansas members.

    Policy Summary
    Payerblue cross blue shield - kansas
    PolicyInterspinous and Interlaminar Stabilization / Distraction Devices (Spacers)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateFeb 1, 2019
    Last ReviewMay 28, 2024
    Next Review DateN/A
    Key ActionObtain prior authorization and document failure of conservative therapy plus planned adjunctive use of an interlaminar spacer with decompression when applicable.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    3FDA-approved devices discussed
    >=6 monthsMin nonoperative treatment (FDA)
    2Investigational stances
    2yMinimum follow-up to judge success
    29% 1yHigher reoperation risk (coflex)

    Coverage Determinations

    Policy determinations

    A: Interspinous or interlaminar distraction devices as a stand-alone procedure

    Considered experimental / investigational per policy

    B: Use of an interlaminar stabilization device following decompression surgery

    Considered experimental / investigational per policy

    Not covered / experimental

    Policy coverage determinations

    Stand-alone use: Interspinous or interlaminar distraction devices as a stand-alone procedure are considered experimental/investigational for treatment of spinal stenosis.

    Policy statement

    Policy Summary
    Payerblue cross blue shield - kansas
    PolicyInterspinous and Interlaminar Stabilization / Distraction Devices (Spacers)
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateFeb 1, 2019
    Last ReviewMay 28, 2024
    Next Review DateN/A
    Key ActionObtain prior authorization and document failure of conservative therapy plus planned adjunctive use of an interlaminar spacer with decompression when applicable.
    SourceLink
    On This Page
    Coverage DeterminationsCoding and Regulatory IdentifiersPrior Authorization, Documentation, and Billing GuidanceClinical Background and ScopeKey DefinitionsPolicy Revision History
    Adjunctive use following decompression: Use of an interlaminar stabilization device following decompression surgery is considered experimental/investigational.

    Policy statement

    Interlaminar spacer as adjunct to decompression — coverage criteria

    Covered when ALL of the following are met

    Candidate selection: Patient has severe lumbar spinal stenosis with grade 1 spondylolisthesis or instability

    From clinical context and populations of interest

    Prior therapy: Failure of conservative management prior to device placement

    Conservative therapies should be documented (see policy for recommended duration)

    Intended use: Interlaminar spacer is planned as an adjunct to spinal decompression (not as a stand-alone device for these indications); comparator surgical options and rationale are documented

    Intervention specified as adjunct to decompression

    Outcomes monitoring: Baseline validated outcome measures documented and plan for follow-up of outcomes for a minimum of 2 years>=2 years

    Outcome measures: ODI, ZCQ, VAS; monitor reoperations and adverse events

    Stand-alone ISD and certain interlaminar uses — limitations and noncoverage considerations

    Not covered or considered unproven when ANY of the following apply

    Stand-alone ISD vs decompression: Interspinous spacers used as a stand-alone treatment have inconsistent evidence and trials/meta-analyses report increased reoperation compared with decompression; lack of robust comparative clinical data limits support for coverage.

    Section summary notes increased reoperation and limited comparative outcomes

    Coflex off-label 2-level use: Use of coflex for 2-level surgery (off-label) is associated with substantially higher reoperation rates compared with bony decompression and is not supported by the evidence for coverage.

    Reported reoperation rates: 38% vs 6% (2-level); 33% vs 8% at 2 years

    Evidence-based findings and limitations

    Clinical evidence findings and interpretation

    Pivotal RCT noninferiority result: An open-label randomized noninferiority trial showed Coflex plus decompression was noninferior to decompression plus posterolateral fusion on composite clinical success at 24 months (prespecified -10% margin).noninferiority margin -10%

    Per pivotal trial (FDA basis for approval)

    Secondary outcomes and safety: Secondary effectiveness measures (ZCQ, VAS, SF-12, recovery time) tended to favor Coflex; device-related adverse events similar overall but wound problems and spinous process fractures were more frequent with Coflex (spinous fractures reported ~14%).

    Device-related adverse events and radiologic findings reported

    Limitations of evidence: Interpretation of noninferiority is confounded because the comparator (fusion) may have uncertain net benefit in some trials; additional RCTs comparing Coflex to decompression alone show mixed results and further prospective trials are needed.

    Evidence beyond pivotal trial limited; registries and retrospective studies have limitations

    Clinical outcome timeframe: Treatment success should be judged with a minimum 2-year post-procedure window, with longer-term data considered when available.>= 2 years

    Minimum follow-up window per outcomes section

    RCT evidence versus decompression alone

    Schmidt et al. RCT (Coflex + decompression vs decompression alone)

    Composite clinical success advantage: In an RCT of moderate-to-severe lumbar stenosis, composite clinical success at 24 months was higher with Coflex plus decompression (58.4%) than decompression alone (41.7%; p=0.017), a treatment difference of 16.7% (95% CI, 3.1% to 30.2%).p=0.017

    Difference driven primarily by fewer epidural steroid injections in the Coflex arm

    No consistent advantage on ODI: Oswestry Disability Index success differences were not statistically significant overall (55% vs 44%; p=0.091) and other patient-reported outcomes showed no consistent statistically significant differences.p>0.05

    Many secondary outcomes non-significant

    Coverage when clinically indicated

    Consider use when ALL of the following are met:

    Eligibility: Patient has symptomatic lumbar spinal stenosis with predominant back pain (often worse than leg pain) and no clinical or radiographic spinal instability or spondylolisthesis beyond grade 1; patient has failed an adequate trial of conservative therapy; interlaminar spacer (eg, coflex) is being implanted as an adjunct to decompression; baseline validated outcome measures are documented and provider commits to ≥2-year follow-up.minimum 2-year outcome window

    Population and follow-up requirements per selection criteria and device labeling/society guidance

    Evidence requirements: Favorable coverage decisions should consider randomized trial data and comparative observational studies but must account for study limitations (open-label design, missing data, biased rescue interventions); absence of clear net health benefit in some populations may render use investigational.

    Per policy evidence appraisal

    Not medically necessary / investigational

    Not medically necessary or investigational when ANY of the following apply:

    Insufficient evidence conditions: Use in populations or circumstances where evidence shows substantial uncertainty in net health outcome (for example, primary trial endpoints driven by rescue injections, high loss to follow-up, lack of intent-to-treat analyses, or major device-related radiologic concerns such as high heterotopic ossification) or when long-term (>2–5 year) outcomes are unavailable.

    Reflects documented trial limitations and potential biases

    Covered indications with criteria

    Covered when ALL of the following are met (per evidence review and professional guidance):

    Patient selection: Patient has symptomatic lumbar spinal stenosis; when used with decompression, selection aligns with device labeling and society guidance (typically moderate stenosis, ≤ grade 1 spondylolisthesis, absence of dynamic instability).

    NASS and ISASS/other society recommendations referenced

    Conservative therapy prior to procedure: Patient has undergone an adequate trial of nonoperative/conservative treatment prior to device implantation (society guidance commonly specifies at least 12 weeks; FDA-labeled devices may specify ≥6 months).>=12 weeks

    Per society criteria and device labeling

    Imaging and instability assessment: Radiographic confirmation of at least moderate lumbar stenosis and absence of gross angular/translatory or dynamic instability at index and adjacent levels (eg, no flexion-extension translation ≥3 mm).no dynamic instability

    Per society criteria and NASS exclusions

    Symptom profile: When used as an alternative to fusion, documentation of significant mechanical back pain unlikely to improve with decompression alone is required in addition to neurogenic symptoms.

    Per NASS coverage recommendations

    Evidence limitations

    Notable evidence limitation/uncertainty:

    Evidence uncertainty: Limitations of published evidence preclude determining effects of interlaminar devices on net health outcome in patients without spondylolisthesis; noninferiority trials using fusion as comparator may be confounded when fusion's net benefit is uncertain.

    From pivotal RCT discussion and subsequent trials

    Coverage stance (explicit excerpts present)

    Policy-level coverage stance statements present in these chunks:

    Stand-alone interspinous/interlaminar distraction devices for spinal stenosis: Interspinous or interlaminar distraction devices as a stand-alone procedure are considered experimental/investigational as a treatment of spinal stenosis.

    Policy statement from 'Policy' section and revision history

    Interlaminar stabilization following decompression: Use of an interlaminar stabilization device following decompression surgery is considered experimental/investigational.

    Policy statement from 'Policy' section and revision history

    Coding and medical necessity linkage: Codes listed are medically necessary ONLY if the procedure is performed according to the 'Policy' section of this document.

    Coding section note linking codes to policy criteria

    FDA device labeling for interspinous and interlaminar implants includes specific contraindications that should guide patient selection. Examples cited in the labeling include: prior fusion or prior decompressive laminectomy at the index level; significant spondylolisthesis (greater than grade 1 or Grade II or greater for some devices); dynamic or structural spinal instability (including isthmic spondylolisthesis or pars defects); severe osteoporosis (DEXA T-score ≤ -2.5); active systemic or local infection; morbid obesity (BMI > 40); known allergy to titanium or titanium alloys; cauda equina syndrome; and spinal anatomy (eg, severe scoliosis) that would prevent stable implantation. These FDA-listed contraindications should preclude device use when present and be documented in clinical records.

    When an interlaminar spacer is considered, the policy distinguishes use as an adjunct to decompression from stand-alone implantation. Coverage may be considered only when the device is planned as an adjunct to open decompression for patients with severe lumbar spinal stenosis and up to grade 1 spondylolisthesis or documented segmental instability, after failure of conservative therapy, and when baseline validated outcome measures are documented with a plan for follow-up of outcomes for at least 2 years.

    The policy notes that certain off-label uses have poor outcomes in published reports; specifically, use of the coflex interlaminar implant for 2-level surgery is labeled off‑label and reported to have substantially higher reoperation rates (eg, 38% vs 6% in one report), and therefore is considered an off-label indication with increased risk that should be documented if proposed.

    Evidence beyond the pivotal randomized trial is limited. The policy highlights sparse published data outside the pivotal RCT, with few full publications from manufacturer registries and limited long‑term comparative series. This gap reduces certainty about real‑world rates of complications and reoperations and limits conclusions about net health benefit.

    Device‑related radiologic findings have been reported whose clinical significance is unclear. Examples include high rates of heterotopic ossification and reports of spinous process erosion around the coflex implant; these radiologic changes warrant ongoing surveillance because their relation to symptoms, device failure, or need for reoperation remains uncertain.

    The policy and cited society guidance specify clinical scenarios where interspinous or interlaminar devices are not indicated. Notable exclusions include degenerative spondylolisthesis Grade 2 or higher, degenerative scoliosis or coronal instability, dynamic instability on flexion‑extension views (eg, translation ≥3 mm), iatrogenic instability, and other anatomic or clinical situations noted in device labeling.

    The policy reiterates the distinction between stand‑alone implantation and use of an interlaminar stabilization device as a post‑decompression adjunct. Devices used as an adjunct to decompression may be considered under defined criteria (eg, grade 1 spondylolisthesis, failed conservative care, documented baseline outcomes and planned ≥2‑year follow‑up), whereas stand‑alone placement for many indications is considered experimental/investigational and not supported by the current evidence base.

    In summary, the policy treats interlaminar/interspinous device placement differently depending on intent: when planned as an adjunct to decompression in appropriately selected patients (eg, severe stenosis with up to grade 1 spondylolisthesis who have failed conservative therapy) and with documentation and outcomes monitoring, the intervention may be considered; as a stand‑alone treatment for spinal stenosis or in other higher‑risk indications, the policy considers the procedure experimental/investigational.

    Placement of interspinous or interlaminar spacers — whether as stand‑alone implants or in combination with decompression — is addressed by this policy. The policy explicitly states that stand‑alone interspinous or interlaminar distraction devices and the use of interlaminar stabilization devices following decompression are considered experimental/investigational and may be denied as not medically necessary, while select adjunctive uses with required documentation may be considered under defined criteria.

    For stand‑alone use, comparative evidence documents higher reoperation rates for some implants. The policy summarizes studies reporting substantially increased reoperation with certain devices (for example, coflex showed higher early reoperation rates compared with decompression in trial data), which supports concern about increased need for subsequent surgery when devices are used as stand‑alone therapy.

    The role of interlaminar/interspinous devices must be interpreted in the context of available comparators. Decompression alone and decompression with fusion are the principal surgical comparators; however, the policy notes that the net benefit of fusion in some populations is uncertain, which complicates interpretation of noninferiority trials that used fusion as the comparator.

    The policy identifies trial design and analytic limitations that could bias reported results. Examples include open‑label designs with use of surgeon‑directed rescue interventions (eg, epidural steroid injections) that drove composite endpoints, high rates of missing outcome data without clear handling methods, and inconsistent intent‑to‑treat reporting — all of which reduce confidence in the magnitude and durability of reported treatment effects.

    For patients without spondylolisthesis or clinical/radiographic instability, the evidence is insufficient to determine net health benefit of adding an interlaminar spacer to decompression. Clinical input and trial data do not universally support improved outcomes in this subgroup, and some experts reported increased complications and reoperation compared with decompression alone.

    Document history entries and policy revisions record explicit statements that certain uses are experimental/investigational. In particular, revisions note that stand‑alone interspinous or interlaminar distraction devices and interlaminar stabilization following decompression were added to the experimental/investigational indications in prior updates, informing the current noncoverage stance for those uses.

    Coding and Regulatory Identifiers

    FDA Premarket Approvals (PMA)mixed
    P040001X Stop PMA
    P110008Coflex PMA
    P140004Superion PMA
    Regulatory / device identifiersmixed
    FDA product code: NQOFDA product code for related device
    Devices referencedmixed
    X-STOPX-STOP Interspinous Process Decompression System (manufacturing stopped 2015)
    coflexcoflex Interlaminar Stabilization device
    SuperionSuperion Interspinous Spacer device
    Clinical trial identifiers referencedmixed
    NCT00692276Identifier for the randomized study comparing Superion to X-STOP (pivotal trial)
    Applicable CPT/HCPCS Codes (informational)CPT | HCPCS
    22867Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level.
    22868Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; second level (List separately in addition to code for primary procedure).
    22869Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level.
    22870Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level (List separately in addition to code for primary procedure).
    Applicable Procedure CPT CodesCPT
    22867Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level.
    22868Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; second level (List separately in addition to code for primary procedure).
    22869Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level.
    22870Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; second level (List separately in addition to code for primary procedure).
    Nonoperative treatment duration
    Nonoperative treatment durationAt least 6 months of nonoperative treatment prior to implantation (per device FDA labeling).
    Society recommendation alternativeSome society guidance allows consideration after ≥12 weeks of nonoperative care when used with decompression, but FDA-labeled devices specify ≥6 months.
    Documentation requirementPrior conservative therapies and duration must be documented in the medical record for prior authorization and medical necessity review.
    Oswestry Disability Index improvement
    ODI improvement thresholdA 15-point improvement on the Oswestry Disability Index (ODI) is used as a meaningful clinical success threshold.
    ODI instrument detailsODI is a self-administered questionnaire quantifying disability for low back pain; maximum score is 50; minimum detectable change (90% CI) is 10 percentage points.
    Use in composite endpointsA ≥15-point ODI improvement is a component of composite clinical success in pivotal trials and RCT definitions.
    Minimum follow-up
    Minimum follow-up duration>= 2 years postprocedure is required as the minimum follow-up window to judge treatment success.
    Outcomes to assess during follow-upSymptoms, function (eg, ODI, ZCQ), reoperations, and adverse events should be assessed during the follow-up period.
    Preference for longer-term dataLonger-term follow-up (eg, 3–5 years or registry data) is desirable when available to assess durability and late adverse events.
    Follow-up window
    Follow-up window (policy)>= 2 years postprocedure is the minimum window to judge treatment success per the policy.
    Validated outcome instrumentsFollow-up should include validated instruments such as ODI, ZCQ, and VAS to evaluate symptoms and function.
    Monitor reoperations and adverse eventsReoperations (including fusion) and device-related adverse events should be tracked over the follow-up window.
    Outcome follow-up duration
    Outcome follow-up durationMinimum 2 years of outcome follow-up is required to judge treatment success, with collection of validated measures and reoperation/adverse event data.
    Common measures in follow-upOswestry Disability Index, Zurich Claudication Questionnaire, and visual analog scale for pain are typically used in follow-up assessments.
    Trial precedentPivotal trials and RCTs report outcomes at 24 months (2 years) as primary windows for assessing composite clinical success.

    Prior Authorization, Documentation, and Billing Guidance

    Prior Authorization

    Prior Authorization Required

    Prior authorization/medical policy review is required for interspinous and interlaminar spacer procedures. Services that are considered experimental/investigational (including stand-alone placement or use following decompression when not meeting policy criteria) may be denied. Coverage decisions follow the policy stance and member contract benefits in effect at time of service.

    • Verify member benefits and obtain prior authorization when applicable.
    • Stand-alone interspinous or interlaminar distraction device procedures are considered experimental/investigational and typically require prior medical review.
    • Use of an interlaminar stabilization device following decompression is considered experimental/investigational unless criteria in the Policy section are met.
    Documentation Required

    Required Clinical Documentation

    Clinical documentation submitted with prior authorization requests must clearly support the diagnosis, prior conservative management, rationale for device type and indication consistent with FDA labeling or society guidance, and planned follow-up/outcomes tracking. Documentation should demonstrate that the interlaminar spacer is being used as an adjunct to decompression when applicable and that the patient has symptomatic lumbar spinal stenosis without instability beyond policy-specified limits.

    • Include diagnosis with radiographic confirmation (eg, MRI, CT, x-ray) showing canal or foraminal narrowing and absence of gross angular/translatory instability when required.
    • State whether device is intended as stand-alone or adjunct to decompression and reference FDA labeling if applicable (eg, Superion, Coflex indications/contraindications).
    • Document prior conservative therapies tried, duration, and outcomes.
    Prior Authorization

    Prior Authorization: Documentation Headline

    Prior authorization requirements include documentation of diagnosis, prior conservative management (including duration and specific therapies), and clinical rationale for device use. For devices with FDA labeling that requires prior nonoperative treatment, document that the patient has undergone the labeled duration (eg, at least 6 months for some devices or ≥12 weeks per society criteria when applicable).

    • For interlaminar spacer used as adjunct to decompression: provide operative plan describing decompression plus spacer implantation and indication that spacer is adjunctive.
    • Document conservative therapy attempted (eg, physical therapy, medications, injections) and duration; preferred minimum windows: 12 weeks (society guidance) or device-specific 6 months when FDA-labeled.
    • If patient medically unable to undergo alternative therapies or anesthesia, include supporting clinical rationale.
    Billing Rule

    Prior Authorization / Coding Note

    When submitting claims, include the applicable CPT codes. Inclusion of codes in this policy is informational only and does not guarantee coverage or reimbursement — the procedures are medically necessary only if performed according to the Policy section and documentation meets medical necessity criteria.

    • Applicable CPT codes include 22867-22870 (see Coding block).
    • When billing these codes, ensure clinical criteria in the Policy are met and prior authorization/medical review documentation is available.
    • Coding inclusion does not imply coverage; verify member contract benefits.
    Denial Risk

    Reoperation-Risk Documentation

    Document and report reoperation risk and prior outcomes when clinically relevant. Published evidence has identified higher reoperation rates with some interspinous devices compared with decompression alone; lack of clinical justification for device selection or inadequate documentation of prior therapies and expected benefit may lead to denial.

    • Include prior surgical history at index and adjacent levels (eg, prior fusion or decompression) because prior fusion at index level is a contraindication.
    • Provide rationale if device is chosen over standard decompression or fusion, including expected benefit and risk tolerance.
    • Report any device-specific complication risks (eg, spinous process fracture rates reported with some devices).
    Documentation Required

    Clinical Documentation and Outcomes Tracking

    Clinical outcomes tracking is expected when devices are implanted. Use validated instruments (eg, Oswestry Disability Index, Zurich Claudication Questionnaire, VAS) and document baseline and planned follow-up assessments, with a minimum 2-year window preferred to judge treatment success.

    • Baseline and follow-up ODI, ZCQ, and VAS scores should be included in records and authorization materials when available.
    • Plan for longitudinal follow-up (minimum 2 years) and documentation of secondary interventions or adverse events.
    • Document whether back pain is mechanical and unlikely to improve with decompression alone when that rationale is used (per NASS guidance).
    Documentation Required

    Document Severity of Back vs Leg Pain

    Document severity and nature of back versus leg pain. If stabilization is proposed because mechanical back pain is predominant and unlikely to improve with decompression alone, provide clinical details supporting that distinction consistent with NASS guidance.

    • Describe pain distribution, aggravating/relieving factors (eg, relief with flexion), and functional impairment.
    • Indicate whether back pain is present at rest and/or with standing/movement and lacks characteristics of neurogenic claudication.
    • Correlate clinical findings with imaging and prior treatment responses.
    Documentation Required

    Clinical Documentation Expectations (per Society Guidance)

    Clinical documentation expectations per society guidance (eg, NASS, International Society for the Advancement of Spine Surgery) include radiographic confirmation of moderate or greater stenosis, absence of gross instability beyond grade 1 when indicated, and documentation of relief in flexion and prior nonoperative treatment of specified duration.

    • Include imaging reports confirming stenosis severity and absence of gross angular/translatory instability.
    • State history of symptom relief with flexion and duration/type of prior conservative care (eg, ≥12 weeks per ISASS or device-specific labeled durations).
    • Note contraindications per FDA labeling (eg, prior fusion at index level, severe osteoporosis, infection) when relevant.
    Documentation Required

    Documentation Supporting Medical Necessity

    Documentation supporting medical necessity must tie the requested procedure to the Policy criteria. CPT codes listed are medically necessary only when the procedure is performed in accordance with Policy clinical criteria and supported by submitted records.

    • Attach operative notes, imaging, conservative therapy records, and postoperative follow-up plans to authorization requests.
    • If billing codes 22867-22870 are used, ensure the procedure met Policy indications (eg, adjunct to decompression when specified) and that supporting documentation is retained.
    Step Therapy

    Step Therapy Considerations

    Step therapy considerations: given uncertainty about comparative effectiveness versus decompression or fusion in some populations, consider sequencing conservative therapies and documenting failure prior to device implantation. Step therapy requirements may be applied in accordance with member benefits and medical review.

    • Document trials of conservative management before requesting authorization for spacer placement.
    • If device is proposed as alternative due to anesthesia or surgical risk, include supporting clinical justification.
    Documentation Required

    Conservative Therapy Attempted and Documented

    Conservative therapy must be attempted and documented prior to consideration of decompression with interlaminar spacer in most cases. The record should list specific therapies, durations, and observed responses.

    • Preferred documentation: physical therapy details, pharmacologic trials, epidural injections, and functional response with timelines.
    • If device labeling or society guidance specifies minimum nonoperative treatment durations (eg, 6 months or 12 weeks), confirm those requirements are met or justified.
    Note

    Coding Inclusion Is Informational

    Coding inclusion in this policy is informational. Presence of CPT/HCPCS codes in the policy does not guarantee coverage or reimbursement — adjudication depends on meeting the policy clinical criteria and member contract provisions.

    • Codes 22867-22870 are listed for informational purposes; verify medical necessity and prior authorization requirements before billing.
    • Inclusion/exclusion of codes does not imply coverage. Always cross-check member benefits.

    Clinical Background and Scope

    Lumbar spinal stenosis results from narrowing of the spinal canal or neural foramina and can produce neurogenic claudication, leg and back pain, and functional limitations that commonly affect older adults. Conservative management (eg, physical therapy, medications, injections) is first‑line; surgical decompression is considered when patients remain symptomatic and functionally limited despite conservative care.

    Key Definitions

    Interspinous spacer — definition and key points
    DefinitionAn interspinous spacer is a small implant placed between adjacent vertebral spinous processes to distract the neural foramina and restrict extension, aiming to decompress nerves and reduce neurogenic claudication.
    MechanismAfter implantation the device is expanded or maintains flexion of the treated interspace to enlarge the neural foramen and decrease nerve compression.
    Use casesMay be used as a less-invasive alternative to decompression surgery or as an adjunct in specific contexts; device-specific labeling and contraindications apply.
    Interlaminar spacer (also called interspinous U or coflex)
    DefinitionAn interlaminar spacer (also called interspinous U or Coflex) is an implant positioned midline between adjacent lamina and spinous processes with winged features that provide dynamic stabilization after decompression or as an alternative to decompression.
    Alternate namesReferred to in some literature and device labeling as interspinous U or Coflex (coflex is an interlaminar stabilization device).
    Intended useOften implanted after decompression to provide stabilization and limit extension; FDA labeling specifies indications and contraindications (eg, prior decompression at index level is contraindicated for some devices).
    Relevant population
    Relevant populationIndividuals with lumbar spinal stenosis and either no spondylolisthesis or low-grade (≤ grade 1) spondylolisthesis are the primary population of interest.
    Severity and instability considerationsPatients considered for interlaminar spacer adjunct to decompression are typically those with severe stenosis and grade 1 spondylolisthesis or limited instability per device labeling and society guidance.
    Conservative therapy prerequisiteCandidates should have failed appropriate conservative management prior to consideration of device implantation.
    Outcome measures
    Validated measuresOutcome assessment typically uses validated instruments: Visual Analog Scale (VAS) for pain, Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF-12/SF-36 for quality of life.
    ODI meaningful changeA 15-point change in ODI is referenced as a meaningful improvement and is used in trial composite endpoints.
    Other outcomesFreedom from secondary interventions (reoperations, injections) and adverse events are key outcome measures alongside symptom and function scores.
    Interlaminar spacer placement
    Placement contextInterlaminar spacer placement is described as an adjunct to spinal decompression for individuals with severe spinal stenosis and grade 1 spondylolisthesis or instability.
    Intended benefitUsed to provide stabilization and a less-invasive alternative to decompression with fusion in selected patients.
    Device labeling noteFDA labeling for interlaminar devices (eg, Coflex) specifies implantation midline between adjacent lamina after decompression and lists contraindications such as prior fusion or decompression at the index level.
    Clinical success window
    Clinical success windowTreatment success should be judged over a minimum follow-up window of 2 years postprocedure, including assessment of symptoms, function, reoperations, and adverse events.
    RationalePolicy and pivotal trials use 24-month endpoints (2 years) for primary assessment of composite clinical success and safety.
    Follow-up elementsIncludes validated instruments (ODI, ZCQ, VAS), documentation of secondary interventions, and device-related complications.
    Composite clinical success (CCS)
    CCS definition (pivotal trial)Composite clinical success (CCS) in the pivotal Coflex trial was defined as at least a 15-point improvement in ODI, no reoperations, no device-related complications, no lumbar epidural steroid injections, and no persistent new or worsening sensory or motor deficit.
    Use in regulatory evaluationThis composite endpoint was used to demonstrate noninferiority of Coflex plus decompression versus decompression plus fusion at 24 months.
    Components trackedODI improvement, reoperations, device-related adverse events, and need for lumbar injections were all components of CCS.
    Composite clinical success (RCT definition)
    RCT CCS criteriaThe randomized trial defined CCS as meeting all 4 criteria: (1) ODI improvement >15 points; (2) survivorship with no secondary surgical intervention or lumbar injection; (3) neurologic maintenance or improvement without worsening; and (4) no device- or procedure-related severe adverse events.
    Reported outcomesIn Schmidt et al., CCS at 24 months favored Coflex plus decompression (58.4%) over decompression alone (41.7%; p=0.017), though ODI-only differences were not statistically significant.
    Interpretation cautionSecondary outcomes and analysis limitations (eg, missing data, open-label design) should be considered when interpreting CCS results.
    Interspinous/interlaminar spacer — general device definition
    Device family definitionInterspinous or interlaminar spacers are implants placed between spinous processes (interspinous) or between laminae (interlaminar) to provide distraction/stabilization and indirect decompression of neural elements.
    Intended effectsThese devices aim to restrict painful extension motion, enlarge neural foramina, and reduce symptoms of neurogenic claudication.
    VariabilityDevices vary in design (eg, expandable interspinous spacers, U-shaped interlaminar implants with wings) and specific labeling, indications, and contraindications.
    Grade 1 spondylolisthesis — definition and relevance
    DefinitionGrade 1 spondylolisthesis is low-grade forward slippage of a vertebral body (≤ grade 1) and is commonly used as an eligibility cutoff for spacer devices.
    Relevance to eligibilityMany device labels and society guidance limit use to patients with grade 1 or less spondylolisthesis and without dynamic instability; grade 2 or higher is a contraindication for several devices.
    Imaging assessmentRadiographic assessment (including flexion-extension views) is required to exclude dynamic instability (eg, translation ≥3 mm) that would preclude device use.
    Interlaminar/interspinous device — general definition
    Device definitionAn interlaminar/interspinous device is an implanted spinal device positioned between spinous processes or within the interlaminar space intended to stabilize or distract a lumbar motion segment.
    Use contextsThese devices may be used as stand-alone implants or in conjunction with decompression surgery; policy and device labeling dictate appropriate indications.
    Regulatory and coding noteDevice-specific FDA approvals, contraindications, and applicable procedure codes (eg, CPT 22867–22870) should be reviewed when planning care and authorization.

    Policy Revision History

    2010-02-08policy_created

    New freestanding Interspinous Distraction Devices (Spacers) medical policy created, developed from prior Minimally Invasive Procedures for Spine Pain policy.

    2011-06-27content_update

    Description, rationale, coding (removed CPT 22899) and references updated.

    2012-02-24content_update

    Description, rationale, and references updated.

    2013-03-19content_update

    Description updated.

    2015-01-23revision

    Title updated to 'Interspinous and Interlaminar Stabilization / Distraction Devices (Spacers)'; added experimental/investigational indication for use of an interlaminar stabilization device following decompressive surgery; description, rationale, coding (added CPT 22899), and references updated.

    2016-06-08content_update

    Description, rationale, and references updated.

    2017-01-01coding_update

    Added CPT codes 22867, 22868, 22869, 22870 (effective Jan 1, 2017) and removed termed codes 0171T and 0172T.

    2017-06-09policy_text_update

    Policy language clarified to explicitly include 'interlaminar' and 'stand-alone procedure' in Item A and wording adjusted in Item B to 'decompression'; rationale and coding bullets updated.

    2019-02-01content_update

    Description, rationale, and references updated; CPT code 22899 and associated coding bullets removed.

    2020-05-18content_update

    Description, rationale, and references updated.

    2021-06-03content_update

    Description, rationale, and references updated.

    2022-06-01content_update

    Description, rationale, and references updated.

    2022-07-01coding_update

    Added temporary code 0719T to Coding section.

    2023-05-23coding_update

    Removed temporary code 0719T and removed ICD-10 diagnoses box; Description, rationale, coding, and references sections updated.

    2024-05-28content_update_archivedLatest

    Description, rationale, and references updated; policy document marked as Archived.