CurrentUnitedHealthcarePolicy CS363KY.03

Interspinous Fusion and Decompression Devices (for Kentucky Only)

Kentucky-only UnitedHealthcare medical policy defining coverage for interspinous fixation (fusion) devices and noncoverage for interspinous decompression and interlaminar stabilization systems without fusion, including applicable procedure codes, definitions, evidence summary, and policy history.

Policy Summary

PayerUnitedHealthcare

PolicyInterspinous Fusion and Decompression Devices (for Kentucky Only)

Policy CodePolicy CS363KY.03

Change TypeRevisions and code removal

Effective DateJun 1, 2025

Next Review Date

Key ActionProviders must document history and radiographic studies confirming disc degeneration and that the device is used with an interbody cage as an adjunct to fusion at a single lumbar level with spondylolisthesis no greater than grade 1.

POLICY UPDATE CHANGES

Coverage Rationale language replaced: 'Interspinous bony fusion devices are proven and medically necessary' changed to 'Interspinous Fixation (fusion) Devices are proven and medically necessary'.

Coverage position language replaced: 'Interspinous decompression systems (without fusion) for the treatment of spine pain or spinal stenosis are unproven and not medically necessary' changed to 'interspinous decompression and Interlaminar Stabilization systems (without fusion) for the treatment of spine pain or spinal stenosis are unproven and not medically necessary'.

Applicable Codes: HCPCS code C1821 removed from list.

Supporting Information: Clinical Evidence and References sections updated to reflect current information.

1State-specific policy (Kentucky only)

2Coverage positions (fusion covered; non-fusion not covered)

Key CPT codes referenced

Coverage Summary

Kentucky-only UnitedHealthcare medical policy CS363KY.03 (Effective Date: June 1, 2025) defines coverage for interspinous devices. Interspinous Fixation (fusion) Devices are covered (proven and medically necessary) when used as an adjunct to interbody fusion at a single lumbar level (L1–S1) and when FDA labeling and the policy’s clinical criteria (for example, discogenic back pain with radiographic degeneration and no more than grade 1 spondylolisthesis) are met. In contrast, interspinous decompression and interlaminar stabilization devices used without fusion are considered not medically necessary due to insufficient evidence of efficacy.

Policy key facts

Effective dateJune 1, 2025

Last reviewJune 1, 2025

Policy numberCS363KY.03

Scope summaryKentucky-only UnitedHealthcare medical policy defining coverage for interspinous fixation (fusion) devices and noncoverage for interspinous decompression and interlaminar stabilization systems without fusion, including applicable procedure codes, definitions, evidence summary, and policy history.

Coverage stance summaryMixed: Interspinous Fixation (fusion) devices are proven and medically necessary when FDA-labeled indications and specified clinical criteria are met; interspinous decompression and interlaminar stabilization systems used without fusion are unproven and not medically necessary due to insufficient evidence of efficacy.

Medical-Necessity Criteria

Interspinous Fixation (fusion) Devices - Medically Necessary

Covered when ALL of the following criteria are met:

ALL of the following

Performed according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings, and precautions
Back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies
Used with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1)
No more than grade 1 spondylolisthesis

Interspinous decompression and interlaminar stabilization systems (without fusion) - Not Medically Necessary

Provider Actions & Billing Guidance

Documentation Required

Document discogenic back pain and radiographic degeneration

Providers must document that the patient has back pain of discogenic origin and radiographic confirmation of disc degeneration when submitting for coverage of interspinous fixation (fusion) devices.

History documenting discogenic back pain
Radiographic studies confirming disc degeneration

Documentation Required

Document fusion adjunct use and level

Document that the interspinous fixation device is being used as an adjunct to interbody fusion with an interbody cage at a single lumbar level and that spondylolisthesis is no greater than Grade 1.

Device used with an interbody cage as adjunct to fusion at a single lumbar level (L1–S1)

Applicable Codes

CPT codes referenced (procedure codes for interspinous devices and related procedures)CPT

22854	Insertion of interbody biomechanical device(s) with integral anterior space in conjunction with interbody arthrodesis, each interspace (List separately in addition to code for primary procedure)
22859	Insertion of intervertebral biomechanical device(s) with integral anterior instrumentation for device anchoring, when performed, in conjunction with interbody arthrodesis, each contiguous defect (List separately in addition to code for primary procedure)
22867	Insertion of intervertebral biomechanical device(s) to intervertebral disc space or vertebral body defect without interbody arthrodesis, each contiguous defect (List separately in addition to code for primary procedure)
22868	Insertion of interlaminar/interspinous process stabilization/distraction device, without fusion, including image guidance when performed, with open decompression, lumbar; single level
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
22899	Unlisted procedure, spine (when specified as insertion of a non-pedicle interspinous process fixation device)

HCPCS removed in revision (previously listed)HCPCS

C1821

Previously listed HCPCS code removed from Applicable Codes in 06/01/2025 revision

Background & Evidence Summary

Interspinous devices include fixation (fusion) devices and decompression/spacer devices (interspinous process devices or IPDs) and interlaminar stabilization implants. Evidence supports the use of interspinous fixation as an adjunct to fusion when FDA labeling and the policy’s specified clinical criteria are satisfied; biomechanical and clinical reports describe these devices as intended to promote stabilization and fusion. By contrast, the quality of evidence for standalone interspinous decompression and interlaminar stabilization is low or uncertain: systematic reviews, technology assessments, and randomized trials report small studies, risk of bias, mixed results versus decompression or fusion, and higher reoperation rates in some analyses, leading to insufficient evidence of long-term efficacy and safety for use without fusion.

Source	Summary
ECRI assessments
ECRI reviews (2019, 2022, 2023) identified low-quality or biased studies for various devices; evidence insufficient for standalone decompression devices and noted need for independent RCTs and longer follow-up
Hayes reviews
Hayes assessments (2020–2023) found very poor or poor quality studies for Superion and mixed/limited evidence for CoFlex; uncertainty due to limited number/fair-quality studies and lack of definitive patient selection criteria
RCT outcomes summary
Randomized trials and meta-analyses show similar short-term outcomes to decompression/fusion for some devices but higher reoperation rates in multiple studies and limited long-term superiority

Definitions

Arthrodesis: A surgical procedure to eliminate motion in a joint by providing a bony fusion to relieve pain, provide stability, overcome postural deformity, or halt advancing disease.

Interlaminar Lumbar Instrumented Fusion (ILIF): Procedure accessing spinous processes via a lower back incision with removal of compressive bone/ligament/disc, placing graft/bone and instrumentation between spinous processes and lamina to achieve fusion.

Revision History

2025-06-01revisedLatest

Coverage Rationale language replaced: 'Interspinous bony fusion devices are proven and medically necessary' changed to 'Interspinous Fixation (fusion) Devices are proven and medically necessary'.

2025-06-01revisedLatest

Policy Summary

PayerUnitedHealthcare

PolicyInterspinous Fusion and Decompression Devices (for Kentucky Only)

Policy CodePolicy CS363KY.03

Change TypeRevisions and code removal

Effective DateJun 1, 2025

Next Review Date

On This Page

Not covered when used without fusion:

Interspinous decompression and interlaminar stabilization systems (without fusion) for the treatment of spine pain or spinal stenosis are unproven and not medically necessary due to insufficient evidence of efficacy

NASS-derived conditional indications for interspinous device without fusion (informational)

NASS 2018/2019 recommendations (informational guidance; not coverage-enabling within this policy):

NASS conditions (informational)

Stabilization with an interspinous device without fusion in conjunction with laminectomy may be indicated as an alternative to lumbar fusion for degenerative lumbar stenosis with or without low-grade spondylolisthesis (<= 3 mm anterolisthesis) with qualifying criteria when appropriate
A lumbar fusion is indicated post-decompression for a diagnosis of lumbar stenosis with a Grade 1 degenerative spondylolisthesis as recommended in NASS
Previous lumbar fusion has not been performed at an adjacent segment
A lumbar laminectomy is indicated as recommended in the NASS Coverage Recommendations for Lumbar Laminectomy
Significant mechanical back pain (in addition to neural compression symptoms) that is unlikely to improve with decompression alone; documentation should indicate back pain present at rest and/or with movement while standing and not characteristic of neurogenic claudication

Spondylolisthesis documented as Grade 0 or Grade 1 (no more than Grade 1)

Denial Risk

Not covered when used without fusion

Claims for interspinous decompression and interlaminar stabilization systems used without fusion are considered unproven and not medically necessary and may be denied.

Billing Rule

Use of CPT 22899 for unlisted interspinous fixation procedures

Report unlisted spine procedures for insertion of a non-pedicle interspinous process fixation device using CPT 22899 and specify the procedure; note that HCPCS code C1821 has been removed effective 06/01/2025.

Use CPT 22899 for unlisted spine procedures when specifying insertion of a non-pedicle interspinous process fixation device
HCPCS C1821 removed effective 06/01/2025

Interlaminar Stabilization Device: An implantable titanium interspinous process device inserted between adjacent spinous processes after decompression to reduce lumbar extension while preserving flexion and rotation.

Interspinous Fixation Devices: Devices intended for attachment to the spinous processes to achieve stabilization and promote fusion in degenerative disc disease.

Interspinous Process Decompression (IPD): Minimally invasive procedure implanting a spacer between affected spinous processes to distract neural foramen and decompress nerves; used after decompression and purported to provide dynamic stabilization.

Lumbar Spinal Stenosis (LSS): Narrowing of the lumbar spinal canal that can compress nerves and cause pain, neurogenic claudication, or neurologic deficits.

Neurogenic Claudication: Symptoms of LSS including buttock/thigh pain or leg weakness relieved by flexion/leaning forward and rest; should be differentiated from vascular claudication.

2025-06-01removedLatest

Applicable Codes: HCPCS code C1821 removed from list.

2025-06-01revisedLatest

Supporting Information: Clinical Evidence and References sections updated to reflect current information; previous policy version CS363KY.02 archived.