Interspinous and Interlaminar Stabilization/Distraction
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Defines Premera Bluecross coverage stance and criteria for interspinous and interlaminar spacer devices used to treat lumbar spinal stenosis and related procedures; intended for providers submitting claims or prior authorization requests.
No material clinical or coverage changes in this revision.
Coverage Determinations and Criteria
Investigational / Not Covered with Criteria
Policy coverage stance
From policy coverage criteria.
Coverage considerations and evidence conclusions
Evidence‑based findings and comparative trial outcomes informing coverage considerations:
Supported by systematic review, RCTs, observational claims analyses; limitations in claims data and comparator groups noted.
Subgroup analyses and open‑label design limit interpretation; prospective trials needed.
Routine addition of spacer to decompression remains uncertain given newer RCTs addressing fusion necessity.
Covered with device-specific criteria
Coverage aligned with device FDA indications and clinical trial evidence; covered when ALL of the following are met (device-specific):
Based on FDA-approved device labeling (e.g., Superion, Coflex)
Contraindications drawn from FDA labeling
Interlaminar stabilization criteria
Coverage stance for interlaminar stabilization when performed with decompression:
Per Coflex FDA labeling
The policy designates the use of an interlaminar stabilization device following decompression surgery as investigational. This means implantation of an interlaminar stabilization device after decompression is not considered established therapy under the policy and would not meet coverage as a medically necessary procedure in that context.
The North American Spine Society (NASS) guidance referenced in the policy indicates that interspinous devices are not indicated outside narrow parameters. NASS states these devices are inappropriate for scenarios including degenerative spondylolisthesis of Grade 2 or higher, degenerative scoliosis or coronal instability, and cases of dynamic instability identified on flexion-extension radiographs (e.g., ≥3 mm translational change).
The policy excludes use in individuals with specified anatomic or stability findings. Examples listed include degenerative spondylolisthesis Grade 2 or higher, degenerative scoliosis or coronal instability, and dynamic instability with ≥3 mm translation on flexion-extension views; such presentations are contraindications to interspinous/interlaminar spacer use per the cited guidance and device labeling.
Devices that are investigational and do not have FDA premarket approval (PMA) are identified in the Appendix and are considered under investigation; use of such devices is not addressed in the Regulatory Status section and is treated as investigational for coverage purposes.
The policy states that interspinous or interlaminar distraction devices used as an alternative to decompression or as stand-alone procedures have demonstrated higher failure and complication rates in the evidence base and are therefore considered investigational / not medically necessary for those indications.
Systematic reviews and randomized trials summarized in the policy report high failure and complication rates and increased reoperation with stand‑alone spacers compared with decompression. These safety and effectiveness concerns underpin the policy’s investigational stance for stand‑alone spacer use.
There is no single national Medicare coverage determination for these devices. The policy notes that NICE concluded interspinous distraction procedures can be efficacious in the short to medium term for carefully selected patients but also highlighted risk of failure and need for further surgery; overall, national-level coverage is not established and guidance varies.
Use of devices that lack FDA premarket approval may not meet coverage requirements. The policy explicitly identifies devices without PMA in the Appendix and indicates those devices are investigational, which creates a potential coverage denial risk if such an unapproved device is billed.
Procedure and Implant Codes
| 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). |
| C1821 | Interspinous process distraction device (implantable) |
| C1821 | HCPCS code C1821 removed (historical note) |
| 22867-22870 | CPT codes added effective 1/1/17 (spinal interlaminar device codes referenced in history) |
| C1821 | HCPCS code referenced as added/removed historically |
Documentation, Prior Authorization, and Billing Guidance
Prior authorization and coding: include CPT 22867–22870 and HCPCS C1821
Include the procedure CPT codes 22867–22870 and HCPCS implant code C1821 on prior authorization requests and claims when applicable; note that the policy lists these codes and that device use as a stand‑alone procedure or as post‑decompression interlaminar stabilization is considered investigational per the coverage criteria.
- CPT 22867, 22868, 22869, 22870 for insertion of interlaminar/interspinous process stabilization/distraction device.
- HCPCS C1821 for implantable interspinous process distraction device.
- Policy states interspinous/interlaminar spacer procedures and use as stand‑alone or post‑decompression stabilization are addressed in the policy (investigational for many uses).
Document imaging confirmation and absence of gross instability for decompression+stabilization
When requesting authorization for interlaminar stabilization with decompression, document radiographic confirmation of at least moderate lumbar stenosis and the absence of gross angular or translatory instability; ensure prior nonoperative treatment is recorded as guideline‑recommended criteria.
- Radiographic confirmation of at least moderate lumbar stenosis (x‑ray, MRI, or CT).
- Documentation of absence of gross angular or translatory instability at the index or adjacent levels.
- Record of prior nonoperative treatment per society guidance.
Confirm FDA device indication criteria (moderate LSS, imaging, flexion relief, prior nonoperative care)
Prior authorization must confirm device‑specific FDA indication criteria are met — including imaging confirmation of moderate degenerative lumbar spinal stenosis, symptoms relieved by flexion, and required duration of prior nonoperative care per device labeling.
- Diagnosis of moderate degenerative lumbar spinal stenosis confirmed by x‑ray, MRI, or CT (thickened ligamentum flavum, narrowed lateral recess, or central canal/foraminal narrowing).
- Patient experiences relief with spinal flexion from leg/buttock/groin pain, numbness, or cramping.
- At least 6 months (device labeling) of prior nonoperative treatment has been attempted (per Superion and Coflex indications).
Verify member benefits and PA requirements before proceeding
Verify member benefits and any prior authorization requirements with the member's benefit booklet or customer service before scheduling the procedure; the policy does not apply to Medicare Advantage plans and coverage depends on the member contract.
- Consult the member benefit booklet or contact member services to determine coverage and PA requirements.
- Note: this medical policy does not apply to Medicare Advantage.
Document failure of conservative management prior to surgical consideration
Document failure of conservative management in the medical record before considering spacer implantation; conservative treatments include physical therapy, pharmacotherapy, and epidural steroid injections as described in the policy context.
- Record specific conservative therapies tried (physical therapy, medications, epidural steroid injections) and responses.
- Document rationale for proceeding to surgical management only after failure of conservative care.
Document ≥12 weeks nonoperative therapy per ISASS before interlaminar spacer+decompression
Record at least 12 weeks of nonoperative treatment when using ISASS criteria for interlaminar spacer with decompression; include specifics of therapies and duration to meet society‑recommended prerequisites.
- Document duration (≥12 weeks) and components of nonoperative care prior to considering interlaminar spacer with decompression per ISASS.
- Specify types of therapies and patient response during this period.
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Coding: list CPT 22867–22870 and HCPCS C1821 on claims/PA
Include CPT codes 22867–22870 and HCPCS C1821 on claims and in prior authorization submissions when applicable to ensure correct processing and review.
- List the applicable CPT procedure code(s) and HCPCS implant code C1821 on the claim/PA.
- Use the CPT descriptions consistent with the AMA coding guidance in the policy.
Required clinical documentation: stenosis severity, spondylolisthesis grade, prior therapies, rationale
Provide clinical documentation of stenosis severity, the presence and grade of spondylolisthesis, prior conservative therapies and their durations, and the clinical rationale for selecting the device versus decompression or fusion given uncertainties in comparative effectiveness.
- Document severity of lumbar spinal stenosis and imaging findings.
- Document presence and grade of spondylolisthesis (e.g., Grade 1 allowed for some devices).
- List prior conservative therapies and durations and rationale for device use.
Required documentation to demonstrate device‑specific indications (imaging, flexion relief, prior nonoperative care)
Demonstrate device‑specific indications in the record: imaging confirmation of moderate degenerative lumbar spinal stenosis (x‑ray, MRI, or CT), symptom relief with flexion, and evidence of prior nonoperative treatment consistent with FDA labeling.
- Include imaging reports showing thickened ligamentum flavum, narrowed lateral recess, or central canal/foraminal narrowing.
- Document clinical history of relief with flexion and functional impairment.
- Include evidence of at least 6 months of prior nonoperative treatment per device labeling.
Benefit verification required: check member benefit booklet or customer service
Consult the member benefit booklet or contact customer service to determine whether the specific service or supply is a covered benefit under the member's plan prior to scheduling or performing the procedure.
- Benefit verification is required because member contracts differ and medical policies do not supersede plan limits.
- Contact member services for plan‑specific coverage details.
Denial risk: stand‑alone spacer procedures considered investigational
Expect denials for claims submitted for interspinous or interlaminar distraction or interlaminar stabilization devices when used as stand‑alone procedures, because the policy considers those uses investigational and not medically necessary.
- Stand‑alone interspinous/interlaminar spacer procedures are considered investigational and would be denied as not medically necessary.
- Refer to the Appendix for devices not addressed in the Regulatory Status.
Denial risk from insufficient clinical documentation and lack of validated outcome measures
Provide clinical context and validated outcome measures in the record (e.g., pain/function scores and rationale for device) because limitations in claims data and reports of higher reoperation/complication rates may lead to coverage denials if documentation is insufficient.
- Include validated outcome measures and clinical details not captured in claims data to support medical necessity.
- Document rationale addressing concerns about higher reoperation or complication rates reported in the literature.
Denial risk for use with device‑listed contraindications (prior fusion/decompression, instability, BMI>40, etc.)
Do not submit claims for use in individuals with device‑listed contraindications (e.g., prior fusion or decompression at the index level, instability beyond device allowance, severe osteoporosis, active/local infection, morbid obesity BMI >40, or known titanium allergy) because these factors are explicit contraindications and would trigger denial risk.
- Contraindications include prior fusion or decompressive laminectomy at the index level, instability greater than device allowance (e.g., > grade 1 or grade II depending on device), severe osteoporosis (DEXA T‑score ≤ −2.5), active infection, morbid obesity (BMI >40), and allergy to titanium.
- Claims for patients meeting these contraindications are at risk for denial.
Clinical Background and Evidence Context
Interspinous and interlaminar spacers are implants placed to distract or stabilize adjacent lamina and/or spinous processes and to restrict extension with the goal of relieving neural compression in lumbar spinal stenosis. Interspinous spacers are placed between spinous processes and expanded to open neural foramina; interlaminar spacers are implanted midline between lamina and spinous processes and often have wings to engage superior and inferior spinous processes.
Interspinous spacer — Small device implanted between adjacent spinous processes that is expanded or opened after insertion to distract the neural foramina and decompress nerve structures; some designs are implanted through a small incision without concurrent laminectomy and preserve the supraspinous ligament, while others require removal of the interspinous ligament and secure around the spinous processes.
Interlaminar spacer — A single‑piece, U‑shaped or winged implant placed midline between adjacent lamina and spinous processes to provide dynamic stabilization after decompression or as an alternative to decompression; the device distracts the laminar space, restricts extension, and typically has pairs of wings around the superior and inferior spinous processes.
Interlaminar spacer (interspinous U) — A variant with a U-shaped geometry and wings that wrap around the superior and inferior spinous processes to distract the laminar space and limit extension while aiming to preserve normal motion.
Indirect decompression (stand‑alone spacer) — Use of an interspinous spacer to achieve neural decompression by distraction alone, without performing a formal laminectomy or bony decompression. The policy highlights that stand‑alone indirect decompression has shown higher failure and complication rates in trials and systematic reviews.
Moderate degenerative lumbar spinal stenosis is defined in device indications and the policy as a radiographically confirmed condition (x‑ray, MRI, or CT) with findings such as thickened ligamentum flavum, narrowed lateral recess, or central canal/foraminal narrowing, accompanied by symptoms (leg/buttock/groin pain, numbness, cramping) that typically improve with flexion.
Device-specific absolute contraindications summarized in the policy include: prior fusion or decompression at the index level, high‑grade spondylolisthesis (e.g., > grade 1 or grade II or greater depending on device), severe osteoporosis, active or local infection, morbid obesity (BMI > 40), and allergy to titanium or titanium alloy; additional contraindications such as specific Cobb angle limits for scoliosis are device‑dependent.
The Appendix lists examples of investigational interspinous and interlaminar devices that do not have FDA premarket approval, including devices such as Aperius PercLID, DIAM, In‑Space, Wallis System, and others; these devices are considered under investigation and are not covered when used outside approved indications.
Terminology and Device Definitions
Policy Revision History
New policy added to Surgery section (initial policy creation).
Interlaminar stabilization added to title and investigational statement added for use following decompressive surgery; new approved device added to regulatory status.
Annual review with literature update; HCPCS code C1821 removed from policy as not used for adjudication and Coflex Cobb angle clarification made in Regulatory Status.
New CPT codes 22867-22870 added effective 1/1/17 (spinal interlaminar device CPT codes).
Removed CPT codes 0171T and 0172T as they terminated 1/1/17.
Policy reinstated after planned deletion; HCPCS code C1821 was later added (and in some history notes removed previously).
Annual Review: policy updated with literature review through February 15, 2023; policy statements unchanged.
Annual Review: policy updated with literature review through February 28, 2024; policy statements unchanged and Related Policies updated.
Annual Review: policy updated with literature review through March 10, 2025; policy statements unchanged.
Annual Review: policy updated with literature review through February 17, 2026; policy statements unchanged (most recent review).
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