FDAnews Device Daily Bulletin

CMS WON'T COVER ARTIFICIAL SPINE DISC REPLACEMENT DEVICE FOR OVER-60 CROWD

July 12, 2006
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The Centers for Medicare & Medicaid (CMS) June 23 announced its decision not to cover lumbar artificial disc replacement (LADR) with the ChariteTM artificial disc for Medicare beneficiaries over 60 years old.

The agency made its national coverage decision after completing a national coverage analysis. The policy went into effect May 16, and must be implemented by insurance carriers July 17 with full implementation by Oct. 1, the agency said.

LADR is a surgical procedure involving complete removal of a damaged or diseased lumbar intervertebral disc and implantation of an artificial disc. The procedure offers 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 agency said.

The FDA has approved the use of the ChariteTM artificial disc, made by DePuy Spine, for spine arthroplasty in skeletally mature patients with degenerative or discogenic disc disease, the CMS said. Medicare coverage under the investigational device exemption for other lumbar artificial discs in eligible clinical trials is not affected, the CMS added.

The CMS decision can be viewed at www.cms.hhs.gov/transmittals/downloads/R60NCD.pdf (http://www.cms.hhs.gov/transmittals/downloads/R60NCD.pdf).