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National Coverage Determination (NCD)

Lumbar Artificial Disc Replacement (LADR)

150.10

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Tracking Information

Publication Number
100-3
Manual Section Number
150.10
Manual Section Title
Lumbar Artificial Disc Replacement (LADR)
Version Number
1
Effective Date of this Version
05/16/2006
Ending Effective Date of this Version
08/14/2007
Implementation Date
07/17/2006
Implementation QR Modifier Date

Description Information

Benefit Category
Inpatient Hospital Services
Physicians' Services


Please 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™ 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™ 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™ 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.

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™ 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.)
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
60
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R60NCD.pdf
Revision History

06/2006 - Upon completion of a national coverage analysis (NCA) for LADR, the decision was made that LADR with the Charite™ 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
Other
  

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.

Coding Analyses for Labs (CALs)

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

Additional Information

Other Versions
Title Version Effective Between
Lumbar Artificial Disc Replacement (LADR) 2 08/14/2007 - N/A View
Lumbar Artificial Disc Replacement (LADR) 1 05/16/2006 - 08/14/2007 You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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