CurrentBlue Cross Blue Shield - Rhode IslandPolicy N/A

Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers)

Policy governing coverage and medical necessity determinations for interspinous and interlaminar spinal spacer devices used to treat lumbar spinal stenosis and related procedures for BlueCHiP Medicare and Commercial members.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyInterspinous and Interlaminar Stabilization/Distraction Devices (Spacers)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 3, 2018

Next Review DateN/A

Key ActionDo not expect coverage for procedures billed with CPT codes 22867–22870; verify member benefits and submit appropriate unlisted CPT codes for device removal when needed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

200,000+people in the U.S. affected (approx.)

6 monthsminimum nonoperative treatment

33% vs 8%reoperation rate (2 yr)

4CPT codes not covered

3FDA‑approved devices (as of Apr 2018)

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Coverage Determinations and Rationale

Not covered / Not medically necessary

BlueCHiP for Medicare - Stand-alone or post-decompression devices: Interspinous or interlaminar distraction devices as a stand-alone procedure are not covered as a treatment of spinal stenosis; use of an interlaminar stabilization device following decompression surgery is not covered.

Removal for medical reasons (device failure, infection, etc.) is covered; insertion of a replacement device after removal is not covered.

Commercial Products - Stand-alone or post-decompression devices: Interspinous or interlaminar distraction devices as a stand-alone procedure are not medically necessary as a treatment of spinal stenosis; use of an interlaminar stabilization device following decompression surgery is not medically necessary.

Removal for medical reasons (device failure, infection, etc.) is covered; insertion of a replacement device after removal is not medically necessary.

Evidence and clinical input

Evidence-based conclusions

Evidence summary: Randomized trials and comparative studies provide mixed results: some devices showed short-term improvements on some measures but trials have limitations; reoperation and complication rates reported with certain implants (eg, coflex) were substantially higher than decompression alone.

Clinical input was mixed; uncertainty remains about long-term benefits and risks and use in patients at high anesthetic risk.

Evidence-based coverage rationale

Summary of clinical evidence and stance

Evidence summary: Evidence is insufficient to determine the effects of interlaminar/interspinous spacers on net health outcomes; randomized trials have methodological limitations, higher reoperation rates with some devices (eg, coflex), and longer-term data are needed to clarify benefits and harms.

Includes uncertainty about comparison with fusion and limited data in patients unable to undergo general anesthesia

Insertion of a replacement interspinous or interlaminar stabilization/distraction device after removal is not covered for BlueCHiP for Medicare and not medically necessary for Commercial products. Removal of an implanted device for medical reasons (for example, device failure or infection) is covered, but subsequent insertion of a replacement device is explicitly excluded from coverage.

Interspinous or interlaminar distraction devices are considered not covered (BlueCHiP for Medicare) or not medically necessary (Commercial products) when used as a stand-alone procedure to treat lumbar spinal stenosis. Similarly, placement of an interlaminar stabilization device following decompression surgery is also not covered / not medically necessary due to insufficient evidence demonstrating net health benefit.

The following CPT codes are listed as not covered for BlueCHiP for Medicare and not medically necessary for Commercial products for insertion of the indicated devices: 22867, 22868, 22869, and 22870. These codes describe insertion of interlaminar/interspinous process stabilization/distraction devices with or without open decompression and with image guidance when performed.

Claims for insertion of interlaminar/interspinous process stabilization/distraction devices billed with CPT codes 22867–22870 should be considered not medically necessary for Commercial products and not covered for BlueCHiP for Medicare; providers should not expect these procedure codes to be reimbursed for the indicated devices.

CPT and Billing Codes

Not covered / Not medically necessary CPT codesCPTNot Covered

22867	Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level
22868	Insertion 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)
22869	Insertion of interlaminar/interspinous process stabilization/distraction device, without open decompression or fusion, including image guidance when performed, lumbar; single level
22870	Insertion 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)

Removal coding guidanceCPT

Unlisted CPT

Appropriate unlisted CPT code should be used for removal of interlaminar/interspinous process stabilization/distraction devices (no specific CPT exists)

Provider Responsibilities and Billing Guidance

Prior Authorization

BlueCHiP for Medicare and Commercial Products: Prior authorization is not applicable.

BlueCHiP for Medicare and Commercial Products — Prior authorization not applicable.

Denial Risk

Coverage Expectation for Listed CPT Codes

CPT codes for insertion of interlaminar/interspinous process stabilization/distraction devices are not covered for BlueCHiP for Medicare and are not medically necessary for Commercial products. Providers should not expect coverage when billing these codes for the indicated procedures.

CPT 22867, 22868, 22869, 22870 — not covered for BlueCHiP for Medicare and not medically necessary for Commercial Products.

Key Terms and Device Definitions

Interspinous spacer — definition and function

DefinitionSmall device implanted between adjacent vertebral spinous processes that is opened or expanded after implantation to distract (open) the neural foramen and decompress nerve roots.

MechanismDistracts spinous processes and/or laminar space and restricts spinal extension to reduce pressure on affected nerve roots and relieve neurogenic claudication.

Typical goalEnlarge neural foramina and decompress nerves to reduce leg/buttock pain and improve function in lumbar spinal stenosis.

Interlaminar spacer — definition and typical use

DefinitionU-shaped or midline implant placed between adjacent lamina and spinous processes to provide dynamic posterior stabilization.

Use context

Clinical Background

Lumbar spinal stenosis (LSS) is a degenerative narrowing of the spinal canal or neural foramina that commonly produces neurogenic claudication characterized by leg and/or buttock pain and functional limitation that typically worsens with standing and walking and improves with lumbar flexion or sitting. Conservative management — including physical therapy, medications, and epidural steroid injections — is the usual initial approach; decompression surgery, with or without fusion, is the standard surgical option when nonsurgical care fails.

Policy Revision Timeline

2018-03-01effective

Policy effective date as published for Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers).

2019-02-05last_reviewLatest

Policy last updated / most recent review recorded for the document.

Policy Summary

PayerBlue Cross Blue Shield - Rhode Island

PolicyInterspinous and Interlaminar Stabilization/Distraction Devices (Spacers)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 3, 2018

Next Review DateN/A

Key ActionDo not expect coverage for procedures billed with CPT codes 22867–22870; verify member benefits and submit appropriate unlisted CPT codes for device removal when needed.

SourceLink

On This Page

Note

Conservative Therapy Expectation

Conservative (nonsurgical) therapy is generally expected prior to consideration of surgical options for lumbar spinal stenosis. Conservative treatments may include physical therapy, pharmacotherapy, epidural steroid injections, and other nonsurgical modalities. Clinical guidance and trials support attempting an adequate course of nonoperative care before surgery.

Conservative (nonsurgical) therapy typically expected prior to surgical consideration; duration and program intensity may vary.

Note

Benefit Verification

Verify member-specific benefits, eligibility, and any applicable coverage limitations prior to providing services. The member's subscriber agreement, certificate, or employer agreement governs benefits and supersedes this policy.

Obtain benefit/eligibility verification from provider call center or payer portal prior to scheduling procedures.

Documentation Required

Supporting Documentation Elements

When submitting claims, include documentation that supports the medical necessity of the service. Manufacturer indications and device labeling typically require imaging confirmation of moderate degenerative lumbar spinal stenosis (x-ray, MRI, and/or CT) and documentation of at least 6 months of nonoperative treatment. For device removal, no specific CPT code exists — use an appropriate Unlisted CPT code and include supporting documentation (reason for removal, operative report, and device identification).

Supporting documentation should include: imaging confirmation of stenosis (x-ray, MRI, and/or CT); documentation of ≥ 6 months of nonoperative therapy; operative reports and device identification for removal.
There is no specific CPT code for removal; submit an appropriate Unlisted CPT code with supporting documentation.

Denial Risk

Coverage Denial Triggers

Interspinous/interlaminar devices used as a stand-alone procedure or placed following decompression surgery may be subject to denial based on coverage policy.

Use as stand-alone procedure and use following decompression are triggers for denial/not medically necessary determination.

Used either following decompressive surgery or as an alternative to decompression to restrict painful motion while enabling normal motion.

Design featuresTypically has two sets of wings placed around inferior and superior spinous processes to distract laminar space and restrict extension.

Composite clinical success measure — trial outcome details

PurposeComposite clinical success is a trial outcome measure combining several endpoints (eg, need for secondary interventions, symptom scores, and other clinical criteria) used to compare devices plus decompression versus fusion or decompression alone.

LimitationsComponents such as decisions to use epidural steroid injections or secondary procedures may be influenced by knowledge of treatment, potentially biasing the measure without standardized, blinded adjudication.

Evidence implicationComposite clinical success outcomes in coflex trials showed noninferiority to fusion for the composite measure, but uncertainty remains due to nonstandardized criteria for secondary interventions and need for longer follow-up (eg, 5-year) to assess net health benefit.

Coflex — device definition and evidence note

Devicecoflex® Interlaminar Technology implant — single-piece U-shaped titanium alloy interlaminar/interspinous spacer used to stabilize the spine after decompression.

Evidence summaryPivotal randomized controlled trials demonstrated noninferiority of coflex plus decompression vs decompression plus fusion for a composite clinical success measure, but trials have limitations and long-term net benefit is uncertain.

Clinical inputExpert opinion was mixed: some support selective use in carefully chosen patients, while others cite concerns about long-term complications and device removal rates; uncertainty exists for patients unable to undergo general anesthesia.