Intervertebral disc replacement or spinal arthroplasty (0090T-0098T), using an artificial disc (e.g., Charité), is considered experimental/investigational as a treatment for degenerative disc disease (722.4, 722.51-722.52, 722.6).  Studies regarding this treatment are inadequate to permit scientific conclusions regarding the long-term safety and efficacy of the replacement disc.  Artificial intervertebral disc replacement is not covered and is not eligible for payment.  A participating, preferred, or network provider can bill the member for this service. 

Description

Degenerative disc disease (DDD) involves deterioration of the intervertebral disc that has been confirmed by patient history and radiographic studies.  DDD can lead to disc dehydration, annular tears, and/or loss of disc height or collapse.  This can result in chronic pain due to resultant abnormal motion of the affected spinal segment, biomechanical instability of the spine, and nerve root compression. 

Spinal fusion is a common surgical approach to degenerative disc disease when conservative treatment (i.e., rest, pain medication, physical therapy) fails.  This process involves joining two or more vertebrae together to produce a more stable spine.  Bone grafting or metal hardware is used to perform a spinal fusion.  Fusion eliminates abnormal motion and instability of the spine by altering the biomechanics of the back.  It also restricts motion, which may cause potential premature disc degeneration at adjacent levels of the spine.

As an alternative, artificial intervertebral discs have been developed for the treatment of degenerative disc disease.  Total disc replacement, or spinal arthroplasty, is intended to restore normal disc height, prevent compression of nerve roots, relieve pain, maintain motion at the affected level of the spine, and maintain the normal biomechanics of the adjacent vertebrae after the damaged disc has been removed. 

The Charité artificial intervertebral disc has received approval from the Food and Drug Administration (FDA) for use as a single lumbar disc replacement specific to the L4-S1 area.

This device uses two metal endplates that are press fit into adjacent vertebrae and a central free component that is held into place by the surrounding soft tissue.  The central component shifts dynamically within the disc space during spinal motion, replicating normal movement.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employees Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition.  Artificial intervertebral disc replacment is considered an eligible service when determined medically necessary based on the patient's condition.

PRN References

04/2006 Artificial spinal disc replacement considered investigational

National Blue Cross Blue Shield Association Medical Policy 7.01.87, Artificial Intervertebral Disc, 04/01/05

Complications of Artificial Disc Replacement-A Report of 27 Patients with the SB Charité Disc”, Journal of Spinal Disorders & Techniques, Vol. 16, No. 4, April 2003

Neurological Complications of Lumbar Artificial Disc Replacement and Comparison of Clinical Results with Those Related to Lumbar Arthrodesis in the Literature: Results of a Multicenter, Prospective, Randomized Investigational Device Exemption Study of Charité Intervertebral Disc”, Journal of Neurosurgery: Spine, Vol. 1, September 2004