Artificial Intervertebral Disc: Lumbar Spine

POLICY NUMBER

A.7.01.87

DESCRIPTION

Total disc replacement, using an artificial intervertebral disc designed for the lumbar spine, is proposed as an alternative to spinal fusion in patients with degenerative disc disease leading to disabling symptoms.

Degenerative disc disease, the most frequent cause of back pain requiring surgery, is common with age or trauma. Spine imaging, such as magnetic resonance imaging (MRI), computed tomography, or plain radiography, shows that lumbar disc degeneration is widespread, but for most people it does not cause symptoms. Potential candidates for artificial disc replacement have chronic low back pain attributed to degenerative disc disease, lack of improvement with nonoperative treatment, and no contraindications for the procedure, which include multilevel disease, spinal stenosis, spondylolisthesis, scoliosis, previous major spine surgery, neurologic symptoms, and other minor contraindications. Patients who require procedures in addition to fusion (eg, laminectomy, decompression) are not candidates for the artificial disc.

When conservative treatment of degenerative disc disease fails, a common surgical approach is spinal fusion. More than 200,000 spinal fusions are performed each year. However, outcomes with spinal fusion have been controversial, in part due to the difficulty in determining if a patient's back pain is related to degenerative disc disease and in part due to the success of the procedure itself. Also, spinal fusion alters the spine biomechanics, potentially leading to premature disc degeneration at adjacent levels, a particular concern for younger patients. During the past 30 years, various artificial intervertebral discs have been investigated as an alternative approach to fusion. This approach, also referred to as total disc replacement or spinal arthroplasty, is intended to maintain normal biomechanics of the adjacent vertebrae and motion at the operative level once the damaged disc has been removed.

Use of a motion-preserving artificial disc increases the potential for various types of implant failure. They include device failure (device fracture, dislocation, or wear), bone-implant interface failure (subsidence, dislocation-migration, vertebral body fracture), and host response to the implant (osteolysis, heterotopic ossification, and pseudotumor formation).

Three artificial lumbar disc devices (activL, Charité, and ProDisc-L) have been approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process (see table below). Production under the name Charité was stopped in 2010 and the device was withdrawn in 2012.

Because the long-term safety and effectiveness of these devices were not known when approved, approval was contingent on completion of post-marketing studies. The activL (Aesculap Implant Systems) and ProDisc-L (Synthes Spine) devices are indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographs. The activL device is approved for use at 1 level. Initial approval for ProDiscL was also limited to patients with disease at 1 level. In April 2020, the ProDiscL indication was expanded to include patients with disease at up to 2 consecutive levels.

U.S. Food and Drug Administration-Approved Lumbar Artificial Disc Devices

PMA: premarket approvalA number of other artificial lumbar discs are in development or available only outside of the United States:

• The INMOTION lumbar artificial disc (DePuy Spine) is a modification of the Charité device with a change in name under the same premarket approval. The INMOTION® is not currently marketed in the United States.

• The Maverick artificial disc (Medtronic) is not marketed in the United States due to patent infringement litigation.

• The metal-on-metal FlexiCore artificial disc (Stryker Spine) has completed the investigational device exemption trial as part of the FDA approval process and is currently being used under continued access.

• Kineflex-L (Spinal Motion) is a 3-piece, modular, metal-on-metal implant. An FDA advisory committee meeting on the Kineflex-L was scheduled in 2013, but was cancelled without explanation.

POLICY

Artificial intervertebral discs of the lumbar spine are considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/2003: Approved by Medical Policy Advisory Committee (MPAC).

1/21/2004: Code Reference section completed, CPT code 22899 added non-covered codes.

7/21/2005: Reviewed by MPAC, remains investigational, Sources updated.

9/15/2005: Code Reference section updated, ICD-9 procedure code 84.60, 84.61, 84.62, 84.63, 84.64, 84.65, 84.66, 84.67, 84.68, 84.69 added.

10/18/2005: Code Reference updated, codes 0090T - 0092T added. Note added to code 22899: Use code 22899 to report artificial intervertebral disc prior to 7-1-2005. For services 7-1-2005 and after, use codes 0090T - 0092T.

3/08/2006: Coding updated. CPT4 2006 revisions added to policy.

12/13/2006: Policy reviewed, no changes.

1/4/2007: Code reference section updated per the 2007 CPT/HCPCS revisions.

5/16/2007: Policy reviewed, description updated. Clarified policy statement to include lumbar spine. Added "Lumbar Spine" to policy title. Code reference section updated; CPT codes 0090T, 0092T, 0093T, 0095T, 0096T, and 0098T removed.

12/5/2008: Policy reviewed, no changes.

12/24/2008: Code reference section updated per the 2009 CPT/HCPCS revisions.

04/12/2010: Policy description updated regarding FDA-approval status of devices. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section. Deleted outdated references from the Sources section. Removed the following codes as they were deleted on 12/31/2006: 0091T, 0094T, and 0097T. Also, deleted unlisted CPT code 22899; this code was only to be used to report artificial intervertebral disc procedure prior to 07/01/2005.

12/29/2010: Policy reviewed; no changes.

12/13/2011: Policy reviewed; no changes.

11/28/2012: Policy reviewed; no changes.

03/11/2014: Policy reviewed; no changes.

03/17/2015: Policy description updated regarding devices. Policy statement unchanged.

08/21/2015: Code Reference section updated to add ICD-10 codes and to remove ICD-9 procedure codes 84.60, 84.61, 84.62, 84.63, 84.66, 84.67, and 84.69.

05/31/2016: Policy number A.7.01.87 added.

08/15/2016: Policy description updated regarding devices. Policy statement unchanged.

06/19/2017: Policy description updated regarding devices. Policy statement unchanged.

05/07/2018: Policy reviewed; no changes.

05/14/2019: Policy reviewed; no changes.

05/26/2020: Policy description updated regarding devices. Policy statement unchanged.

07/22/2021: Policy description updated regarding devices. Policy statement unchanged.

06/06/2022: Policy description updated regarding devices. Policy statement unchanged.

12/19/2022: Code Reference section updated to add new CPT code 22860 and to revise the description for CPT code 22857, effective 01/01/2023.

05/22/2023: Policy reviewed; no changes.

05/22/2024: Policy reviewed. Policy statement unchanged. Code Reference section updated to remove deleted CPT code 0163T.

05/15/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.87 

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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