CurrentBlue Cross Blue Shield - IowaPolicy N/A

Annular Closure Devices

This policy governs the use of annular closure devices after lumbar discectomy for members of the payer and determines coverage status based on available evidence for patients with large annular defects.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAnnular Closure Devices

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2023

Next Review DateAug 1, 2025

Key ActionPrior authorization should confirm indication details and supporting documentation including failed ≥6 weeks conservative therapy, single-level L4-5 or L5-S1 disease, posterior disc height ≥5 mm, and intraoperative confirmation of a large annular defect.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PMA 2019FDA approval

1 in 10Recurrence after discectomy

4-6 x 6-10 mmAnatomic sizing

L4-S1Levels in indication

2RCTs identified

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Follow-up showing benefit

Coverage determination and criteria

Not medically necessary / Investigational

Covered when ALL of the following are met

Policy coverage determination: The use of an annular closure device following discectomy is considered investigational because the evidence is insufficient to determine the effects of this technology on net health outcomes.

Based on systematic review and RCTs with methodological limitations (e.g., lack of blinding).

Initial coverage criteria

Covered when ALL of the following are met

Population and prior treatment: Patient has symptomatic lumbar disc herniation with radiculopathy who failed ≥6 weeks of nonsurgical/conservative treatment.≥6 weeks

Supported by RCT inclusion criteria (Thomé et al., Cho et al.) and guideline statements.

Anatomic and procedural criteria: Single-level lumbar disc herniation (commonly L4-5 or L5-S1) with preserved posterior disc height ≥5 mm and an intraoperatively visualized large annular defect (height 4–6 mm and width 6–10 mm).disc height ≥5 mm; annular defect 4–6 mm tall and 6–10 mm wide

ISASS position and RCT eligibility criteria.

Intervention timing: Device implanted at the time of primary discectomy as an adjunct to reduce reherniation.implant at index discectomy

Trials evaluated annular closure device implanted during the index discectomy.

Other annular closure devices that do not have current U.S. availability or FDA clearance are not applicable for U.S. use. Examples noted in the source include older 510(k)-cleared products no longer marketed (Annulex systems) and devices with CE Mark but no FDA clearance (DART). The only bone-anchored device with FDA PMA approval referenced is Barricaid® (PMA #P160050) for specified defect sizes and spinal levels.

Use of annular closure devices for patients who fall outside the anatomic and trial-eligible parameters is not supported by the available evidence. The clinical trials and meta-analyses informing the policy focused on single-level disease (commonly L4-5 or L5-S1) with intraoperative confirmation of a large annular defect (commonly described as 4–6 mm tall by 6–10 mm wide) and preserved posterior disc height. Indications such as multilevel disease or cases without an intraoperatively demonstrated large annular defect were not evaluated in those trials and therefore lack supporting evidence.

The coding section of the document provides guidance on which procedure codes (for example, CPT 22899, HCPCS C9757, and CPT 63032) may be used to report annular closure device procedures, but this excerpt does not itself establish separate, explicit coverage criteria or medical necessity rules tied to those codes.

The policy concludes that the use of an annular closure device following discectomy is investigational. Systematic reviews and randomized trials have been identified, but limitations — including lack of blinding in key trials and overall uncertainty about net health outcomes — lead to the determination that evidence is insufficient to support that the technology improves clinically meaningful outcomes.

When the stated coverage criteria are not met, the policy regards use of annular closure devices as not supported because available evidence is limited and of low-to-moderate quality. Reported device-specific risks in the literature include device failure (migration, detachment, or anchor failure), wound complications, and procedure-related lower-extremity pain; these safety concerns, combined with methodological limitations of the studies, underpin the investigational stance when criteria are unmet.

Within the provided excerpt there are no additional explicit statements framed as separate 'not medically necessary' rules beyond the overall investigational policy language; ongoing and unpublished clinical trials are noted as potentially influential for future review.

Procedure and billing codes

Codes table referencedmixed

No codes listed

Referenced CPT CodesCPT

22899

Unlisted procedure, spine

Referenced HCPCS CodesHCPCS

C9757

Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and excision of herniated intervertebral disc, and repair of annular defect with implantation of bone anchored annular closure device, including annular defect measurement, alignment and sizing assessment, and image guidance; 1 interspace, lumbar.

Additional CPT CodesCPT

63032

Laminotomy (hemilaminectomy), with decompression of nerve root(s), including partial facetectomy, foraminotomy and/or excision of herniated intervertebral disc; with repair of annular defect by implantation of bone anchored annular closure device, including all imaging guidance, 1 interspace, lumbar (List separately in addition to code for primary procedure).

Anular defect size threshold

Anular defect size threshold4-6 mm tall and 6-10 mm wide

FDA-approved device indicationBarricaid approved for defects 4-6 mm tall by 6-10 mm wide (single level L4–S1)

Trial/Guidance sizingISASS and trials use 4–6 mm (height) × 6–10 mm (width) to define large defects

Posterior disc height

Posterior disc height requirement≥5 mm (posterior disc height)

Trial enrollment criterionThomé et al RCT required disc height ≥5 mm

Prior authorization, documentation, and billing guidance

Prior Authorization

Prior Authorization / Authorization

Prior approval is not applicable for this policy. The use of an annular closure device following discectomy is considered investigational and may be denied as not medically necessary when submitted as a covered service.

Prior Authorization

Prior authorization: indication verification

Verify that the clinical indication meets the limited clinical scenario where evidence has been evaluated: symptomatic single-level lumbar disc herniation (typically L4-5 or L5-S1) confirmed by history, physical exam, and imaging; a large annular defect visualized after discectomy (approximately 4–6 mm tall and 6–10 mm wide); and other device-specific anatomic criteria such as posterior disc height (≥5 mm) when applicable. Document the single affected level and that the procedure is a primary discectomy at that level.

Confirm single-level disease (L4-5 or L5-S1 preferred)
Document clinical confirmation of radiculopathy (history, exam, imaging)
Document intraoperative annular defect measurements (height and width)
Document posterior disc height (≥5 mm) when available

Clinical background and rationale

Lumbar disc herniation can compress spinal nerves and cause radicular back and leg pain, numbness, or weakness. Discectomy is a surgical procedure performed to remove herniated disc material and relieve nerve compression. Annular closure devices are implanted at the time of primary discectomy as an adjunct intended to close a large annular defect and reduce the risk of recurrent herniation; however, the policy review found insufficient evidence to conclude that use of these devices improves net health outcomes despite trials demonstrating reduced reherniation in some analyses.

Key definitions and terms

Discectomy definition

DefinitionSurgical removal of herniated intervertebral disc material to relieve pressure on affected nerve roots

ApproachesIncludes open discectomy (2–3 cm incision, possible partial lamina removal) and microdiscectomy (minimally invasive, smaller incision and specialized instruments)

PurposeIntended to treat symptoms of nerve compression such as pain, numbness, and weakness by removing extruded disc material

Annular closure device (bone-anchored)

DescriptionA bone-anchored implant placed at time of discectomy to close large annular defects and reduce risk of reherniation

Example (brand)Barricaid® — FDA PMA approval 2019 for specified defect sizes and levels

Policy development and review timeline

2025-08-01Annual review / RenewalLatest

Annual review and renewal of the policy completed (documented as Annual Review and Renewal).

2024-10Annual review / Policy renewed

Annual review performed and policy renewed (October 2024).

2023-10-01Policy creation

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyAnnular Closure Devices

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2023

Next Review DateAug 1, 2025

SourceLink

On This Page

ISASS guidanceISASS specifies moderately preserved disc height: ≥5 mm posterior height

Annular defect size (width)

Annular defect width6-10 mm (width)

FDA indication contextWidth 6–10 mm specified for Barricaid approval

ISASS descriptionISASS describes large annular defect width between 6 and 10 mm visualized intraoperatively

Annular defect size (height)

Annular defect height4-6 mm (height)

FDA indication contextHeight 4–6 mm specified for Barricaid approval

ISASS descriptionISASS describes large annular defect height between 4 and 6 mm visualized intraoperatively

Prior Authorization

Prior authorization for annular closure device procedures

Obtain prior authorization when reporting unlisted spine procedures or the specific HCPCS for implantation of an annular closure device. Use appropriate coding and include required documentation (see billing/coding callouts) to support medical necessity; absence of required prior auth or insufficient documentation may lead to denial.

When using unlisted CPT (22899), attach operative report and device documentation
When using HCPCS C9757 include full operative notes and annular defect measurement documentation

Documentation Required

Conservative therapy before surgery

Document a trial of conservative, nonoperative management before considering surgical intervention. Initial care is expected to be conservative because many disc herniations improve with time.

Record types of conservative measures used (analgesics, physical therapy, activity modification, chiropractic care, epidural steroid injections, etc.)
Document response to these measures and dates of therapy

Step Therapy

Conservative management duration

Conservative management is expected for at least 6 weeks (≥6 weeks) prior to consideration of discectomy with annular closure device, unless there are rapidly progressing neurologic deficits or other urgent surgical indications. Explicitly document the duration and failure of conservative care.

Document start and end dates of conservative therapy showing ≥6 weeks duration
If surgery was performed earlier due to progressive neurologic deficit, document the urgent indication

Documentation Required

Required device and anatomy documentation

Required operative and device documentation must be included with claims or prior authorization requests: clearly identify the device as a bone-anchored annular closure implant (manufacturer and model when available), intraoperative measurements of the annular defect (height and width), assessment of implant sizing and alignment, and any image guidance used. Also document that the device sizing matches the defect criteria.

Device identification: manufacturer and model (e.g., Barricaid®) when used
Intraoperative annular defect measurements (height and width) documented in operative note
Documentation of implant alignment, sizing assessment, and use of image guidance
Specify that defect size falls within the device labeling criteria (when claimed)

Documentation Required

Documentation to demonstrate symptomatic lumbar disc herniation and conservative treatment failure

Provide documentation demonstrating symptomatic lumbar disc herniation with radiculopathy and failure of conservative therapy. Include clinical history, physical exam findings, imaging reports, and documentation that symptoms are attributable to the indexed level. Ensure the record supports single-level disease and corresponds to the operative findings.

Clinical history and exam consistent with radiculopathy
Imaging (MRI/CT) correlating with symptoms and operative level
Operative report confirming single-level disease and intraoperative findings

Billing Rule

Procedure documentation and coding-related denial risk

When reporting procedures and billing, use the appropriate CPT/HCPCS codes and include supporting documentation to reduce coding-related denial risk. Submit the operative report, device documentation, annular defect measurements, and evidence of conservative management. Studies with duplicative or overlapping populations were excluded from evidence summaries; similarly, submit unique and complete documentation that does not rely on duplicate or unclear records.

Attach full operative report and device implant documentation when using unlisted CPT 22899
Include annular defect measurement and sizing documentation when billing HCPCS C9757
Provide clear, non-duplicative clinical records to support medical necessity

Denial Risk

Evidence limitations and denial risk

Evidence limitations and exclusion of duplicative studies may influence coverage decisions. The device is considered investigational in this policy because available evidence is insufficient to determine net health outcomes; incomplete, overlapping, or duplicative clinical documentation can contribute to noncoverage determinations.

Be aware that insufficient or overlapping clinical evidence in the record may trigger denial
Ensure submitted evidence is complete, unique, and directly relevant to the member and procedure

Intended useUsed following primary discectomy for large annular defects (device is the only currently FDA-approved annular closure device in the U.S.)

Large annular defect

Intraoperative definitionAn annular defect visualized intraoperatively after discectomy described as a 'large annular defect' when height is 4–6 mm and width is 6–10 mm

Typical measurementsHeight commonly 4–6 mm; width commonly 6–10 mm per ISASS and trial criteria

Associated trial eligibilityTrials and guidance specify large annular defect visualized intraoperatively and measured to meet sizing thresholds

Back and Leg Pain Measures

Composite outcome measuresIncludes patient-reported instruments such as Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), RMDQ, and visual analog scales (VAS) for back and leg pain

ODI detailsODI measures functional disability and pain related to back conditions (scores 0–50 or 0–100%); MCID/MDD benchmarks noted in table

VAS and RMDQVAS for back/leg pain (0–100 scale) and RMDQ for disability are used; MCID/MDD values provided in outcomes table

HCPCS code C9757

HCPCS codeC9757 — Laminotomy (hemilaminectomy) with decompression and repair of annular defect with implantation of bone-anchored annular closure device; includes annular defect measurement, alignment and sizing assessment, and image guidance; 1 interspace, lumbar.

Use guidanceReport when implantation of a bone-anchored annular closure device is performed, per coding section

Associated reportingUse appropriate CPT/HCPCS and include documentation of implantation, annular defect measurement and image guidance as applicable

CPT 22899

CPT code22899 — Unlisted procedure, spine

When to useUsed to report provider services when no specific CPT exists for the annular closure implantation procedure

Prior authorization noteProviders should obtain any required prior authorization per payer rules when reporting unlisted spine procedures

CPT 63032

CPT code63032 — Laminotomy (hemilaminectomy) with decompression of nerve root(s) with repair of annular defect by implantation of bone-anchored annular closure device; includes imaging guidance; 1 interspace, lumbar (list separately in addition to primary procedure).

Reporting guidanceList separately in addition to code for the primary decompression/discectomy procedure when applicable

Coding contextIncluded in procedure coding group for annular closure device implantation

Policy originally created and became effective in October 2023 (new policy).