Lumbar Artificial Disc Replacement (LADR) Form

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Notes: For Medicare beneficiaries 60 years of age and younger, coverage determinations are made by the local Medicare Administrative Contractors.

Indications

(947096) Is the patient skeletally mature with degenerative or discogenic disc disease at one level from L3 to S1? 

Contraindications

(947097) Is the patient over 60 years of age? 
(947098) Is the service date before May 16, 2006 or after August 13, 2007? 
(947099) Is the device being used the Charite™ lumbar artificial disc for service dates between May 16, 2006 and August 13, 2007? 
Effective Date

08/14/2007

Last Reviewed

NA

Original Document

  Reference



Background for this Policy

A. General

The lumbar artificial disc replacement (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. The Food and Drug Administration has approved the use of LADR for spine arthroplasty in skeletally mature patients with degenerative or discogenic disc disease at one level for L3 to S1.

B. Nationally Covered Indications

N/A

C. Nationally Non-Covered Indications

Effective for services performed from May 16, 2006 through August 13, 2007, the Centers for Medicare and Medicaid Services (CMS) has found that LADR with the Charite™ lumbar artificial disc is not reasonable and necessary for the Medicare population over 60 years of age; therefore, LADR with the Charite™ lumbar artificial disc is non-covered for Medicare beneficiaries over 60 years of age.

Effective for services performed on or after August 14, 2007, CMS has found that LADR is not reasonable and necessary for the Medicare population over 60 years of age; therefore, LADR 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 for LADR, leaving such determinations to continue to be made by the local Medicare Administrative Contractors.

For dates of service May 16, 2006 through August 13, 2007, Medicare coverage under the investigational device exemption (IDE) for LADR with a disc other than the Charite™ lumbar disc in eligible clinical trials is not impacted.

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