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National Coverage Determination (NCD) for Lumbar Artificial Disc Replacement (LADR) (150.10)

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Publication Number

100-3

Manual Section Number

150.10

Manual Section Title

Lumbar Artificial Disc Replacement (LADR)


Version Number

2

Effective Date of this Version

8/14/2007

Implementation Date

10/1/2007



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. The FDA has approved the use of the lumbar artificial disc for spine arthroplasty in skeletally mature patients with degenerative or discogenic disc disease at one level for L 3 to S1.


Indications and Limitations of Coverage

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 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.

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 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 TM lumbar disc in eligible clinical trials is not impacted.

(This NCD last reviewed August 2007.)


Claims Processing Instructions
Transmittal Number

75

Revision History

06/2006 - Upon completion of a national coverage analysis (NCA) for LADR, the decision was made that LADR with the Charite TM lumbar artificial disc is non-covered for Medicare beneficiaries over 60 years of age. Effective date for Carriers: 07/17/2006 Effective date for FI's: 10/01/2006.(TN 60) CR5057

09/2007 Effective date: 08/14/2007. Implementation date: 10/01/2007. (TN 75) CR5727


National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Other Versions
71