Benefit Category
Inpatient Hospital Services
Physicians' Services
Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.
Item/Service Description A. General
The LADR is a surgical procedure on the lumbar spine that involves complete removal of the damaged or diseased lumbar intervertebral disc and implantation of an artificial disc. The procedure may be done as an alternative to lumbar spinal fusion and is intended to reduce pain, increase movement at the site of surgery and restore intervertebral disc height. This national coverage determination focuses on LADR with the Charite TM lumbar artificial disc because it is the only Food and Drug Administration (FDA) approved lumbar artificial disc at this time. The FDA has approved the use of the Charite TM artificial disc for spine arthroplasty in skeletally mature patients with degenerative or discogenic disc disease at one level for L4 to S1.
Indications and Limitations of Coverage B. Nationally Covered Indications
N/A
C. Nationally Non-Covered Indications
Effective for services performed on or after May 16, 2006, the Centers for Medicare and Medicaid Services has found that LADR with the Charite TM lumbar artificial disc is not reasonable and necessary for the Medicare population over 60 years of age; therefore, LADR with the Charite TM lumbar artificial disc is non-covered for Medicare beneficiaries over 60 years of age.
D. Other
For Medicare beneficiaries 60 years of age and younger, there is no national coverage determination, leaving such determinations to continue to be made by the local contractors.
Since this NCD focuses on LADR with the Charite TM lumbar artificial disc, Medicare coverage under the investigational device exemption (IDE) for other lumbar artificial discs in eligible clinical trials is not impacted.
(This NCD last reviewed May 2006.)
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