Latest Review Date:   October 2023

Category:  Surgical    

POLICY:

The use of an annular closure device following discectomy is considered investigational.

DESCRIPTION OF PROCEDURE OR SERVICE:

The vertebral disc is composed of two parts: the nucleus pulposus and the annulus fibrosus. The nucleus pulposus is a gelatinous substance at the center of the disc and distributes hydraulic pressure in all directions within the disc under compressive loads. The nucleus pulposus consists of chondrocytes, collagen fibrils, and proteoglycan aggregates. The annulus fibrosus encircles the nucleus pulposus and is made up of tough, fibrous layers. Both structures fit together like two concentric cylinders. The nucleus pulposus bears the axial load of the body and acts as pivot point for movement. The annulus fibrosus acts as a barricade to contain the nucleus pulposus and its hydraulic pressure so it maintains its load bearing and pivot functions.

An annular closure device has been purported for treatment following a spinal decompression (discectomy) surgery. It has been suggested that annular closure may reduce the risk of disc reherniation and the need for a fusion. In patients with large annular defects following lumbar discectomy, annular closure devices have been proposed to reduce the risk of recurrence and reoperation. Although many devices and techniques have been investigated, a bone-anchored implant is the only device currently approved by the Food and Drug Administration (FDA).

KEY POINTS:

The most recent literature update was performed through July 28, 2023.

For individuals who have a lumbar herniated disc and undergo discectomy, use of a bone-anchored annular closure device has been evaluated as a means to reduce reherniation and reoperation in a systematic review and RCTs. Relevant outcomes are symptoms, functional outcomes, health status measures, quality of life, and treatment-related mortality and morbidity. Although a key RCT found beneficial effects in terms of reoperation and reherniation, the evidence is limited by a lack of blinding in patients with lumbar radiculopathy with disc herniation who receive discectomy and an annular closure device. The evidence is insufficient to determine that the technology results in an improvement in net health outcomes.

For individuals who have had a lumbar discectomy with Inclose™ Surgical Mesh System or the DART system there are no studies currently published in the peer-reviewed medical literature to support the safety and efficacy of these technologies, or that it would improve net health outcomes.

Practice Guidelines and Position Statements

International Society for the Advancement of Spine Surgery

In 2019, the International Society for the Advancement of Spine Surgery (ISASS) published a policy on the surgical treatment of lumbar disc herniation with radiculopathy. This policy contained a review of available clinical evidence and concluded that discectomy (open, microtubular, or endoscopic) is a medically necessary procedure for the treatment of patients who do not respond to nonsurgical care or have severe and deteriorating symptoms. Per the policy, documentation requirements include confirmation of radiculopathy based on history/physical examination AND either the presence of disabling leg or back pain refractory to 6 weeks of conservative care or progressive neurologic deficit AND level appropriate documentation of nerve root compression on imaging and/or nerve conduction velocity/electromyogram. The ISASS also included specific recommendations for bone-anchored annular closure devices as follows:

• "Patient is indicated for a primary discectomy due to a posterior or posterolateral herniation,
• Discectomy will be performed at a single level that includes L4-L5 or L5-S1,
• The annular defect is large (between 4 and 6 mm tall and between 6 and 10 mm wide) after completion of the discectomy procedure."

KEY WORDS:

Annular closure device, ACD, annular defect, lumbar disc herniation, reherniation, Barricaid, XCLOSE®, INCLOSE, bone-anchored annular closure device, DART system, disc annular repair technology system, Anchor Knot

APPROVED BY GOVERNING BODIES:

Barricaid®, a bone-anchored annular closure device, was approved by the FDA in 2019 for use in patients with large annular defects (4-6 mm tall and 6-10 mm wide) following a primary discectomy procedure at a single level between L4 and S1.

The AnchorKnot Tissue Approximation Kit (Anchor Orthopedics, Mississauga, ON, Canada) system enables minimally invasive visualization of the surgical field and is intended to minimize the removal of disc tissue and to close the AF defect with sutures.  Although reports indicated the device has been used in multiple clinics, systematic evaluation of its safety and efficacy for disc repair is not yet available, apart from an in-vivo porcine study.  The device is currently only indicated for visualization of the surgical field.

The Disc Annular Repair Technology (DART) System (Magellan Spine Technologies, Inc., Irvine, CA) received European CE Mark approval in 2009. The DART system has not currently received FDA marketing clearance in the United States. 

Both the Xclose® Tissue Repair System and the Anchor Band Suturing System, (Anulex Technologies, Inc., Minnetonka, MN) received initial FDA marketing approvals in 2006. As of late 2022, it appears that the Xclose device is no longer available on the market in the U.S.

The Inclose™ Surgical Mesh System (Anulex Technologies, Inc., Minnetonka, MN), received initial FDA marketing approval in 2005. This device is no longer available in the U.S.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING: 

CPT Codes:

REFERENCES:

1. Barth M, Fontana J, Thomé C, et al. Occurrence of discal and non-discal changes after sequestrectomy alone versus sequestrectomy and implantation of an anulus closure device. J Clin Neurosci. Dec 2016; 34: 288-293.
2. Cho PG, Shin DA, Park SH, et al. Efficacy of a novel annular closure device after lumbar discectomy in korean patients: A 24-month follow-up of a randomized controlled trial. J Korean Neurosurg Soc. Nov 2019; 62(6): 691-699.
3. Guardado AA, Baker A, Weightman A, Hoyland JA, Cooper G. Lumbar Intervertebral Disc Herniation: Annular Closure Devices and Key Design Requirements. Bioengineering (Basel). 2022 Jan 19;9(2):47.
4. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
5. Kienzler JC, Klassen PD, Miller LE, et al. Three-year results from a randomized trial of lumbar discectomy with annulus fibrosus occlusion in patients at high risk for reherniation. Acta Neurochir (Wien). Jul 2019; 161(7): 1389-1396.  
6. Lorio M, Kim C, Araghi A, et al. International Society for the Advancement of Spine Surgery Policy 2019-SurgicalTreatment of Lumbar Disc Herniation with Radiculopathy. Int J Spine Surg. Feb 2020; 14(1): 1-17.
7. Miller LE, Allen RT, Duhon B, et al. Expert review with meta-analysis of randomized and nonrandomized controlled studies of Barricaid annular closure in patients at high risk for lumbar disc reherniation. Expert Rev Med Devices. May 2020;17(5): 461-469.
8. Peredo AP, Gullbrand SE, Mauck RL, Smith HE. A challenging playing field: Identifying the endogenous impediments to annulus fibrosus repair. JOR Spine. 2021;4(1):e1133.
9. Thomé C, Klassen PD, Bouma GJ, et al. Annular closure in lumbar microdiscectomy for prevention of reherniation: a randomized clinical trial. Spine J. Dec 2018; 18(12): 2278-2287.
10. Thomé C, Kuršumovic A, Klassen PD, et al. Effectiveness of an Annular Closure Device to Prevent Recurrent Lumbar Disc Herniation: A Secondary Analysis With 5 Years of Follow-up. JAMA Netw Open. Dec 01 2021; 4(12): e2136809.
11. Vukas D, Ledić D, Grahovac G, et al. Clinical outcomes in patients after lumbar disk surgery with annular reinforcement device: two-year follow up. Acta Clin Croat. Mar 2013; 52(1): 87-91.

POLICY HISTORY:

Medical Policy Group, October 2023 (7): New policy addressing annular closure devices following discectomy.

Medical Policy Administration Committee, October 2023

Available for comment November 1, 2023 through December 16, 2023.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members.  Our decisions concern coverage only.  The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient.  The plan administers benefits based on the member's contract and corporate medical policies.  Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients.  Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage. 

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.