Lumbar Artificial Disc Replacement Not Covered In People Over 60

Medicare has decided it will not pay for lumbar artificial disc replacements in people over 60 years of age. The reasoning for the CMS' (The Centers for Medicare and Medicaid Services) decision is the lack of data on using such devices in the 60+ population, according to Scott Boden, MD, a Spine-health.com Medical Advisor.

This August 2007 decision affects the Prodisc-L (made by Synthes), approved by the FDA in August 2006. The first lumbar artificial disc approved by the FDA in 2004, the Charite disc (made by DePuy Spine, a Johnson & Johnson company), was already covered by a similar decision made by CMS in May 2006.

Both the Prodisc and Charite disc FDA IDE clinical studies tested patients between the ages of 18 and 60. Based on the age limitations in these studies and in Medtronic’s Maverick lumbar disc study, CMS says it “is convinced that the indications for LADR will exclude the over age 60 population, and that these age limitations are not specific to one manufacturer’s disc implant.”

What about people under age 60 with pain and disability from lumbar degenerative disc disease, the prevalent and severe condition the artificial disc was designed to treat? It’s still left up to individual insurance companies to decide. The CMS acknowledged “some evidence does exist for patients age 60 and under” to benefit from artificial disk technology. However, it believes the ProDisc clinical trial design created more uncertainty in benefits and thus would not come forth with a statement supporting artificial disc replacement in the under age 60 population.

For those of you interested, the exact wording of the decision is below.

The original CMS decision about Lumbar Artificial Disc Replacement was made on May 16, 2006, and was specific to the Charite Disc, the only lumbar artificial disk available at the time:

“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. 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. Medicare coverage under the investigational device exemption (IDE) for other lumbar artificial discs in eligible clinical trials is not impacted.”

On August 14, 2007, the CMS issued the following in its decision memo:

“The Centers for Medicare and Medicaid Services (CMS) has determined that LADR is not reasonable and necessary for the Medicare population over sixty years of age. Therefore, Section 150.10 of the Medicare National Coverage Determination (NCD) Manual is amended to reflect the change from non-coverage for LADR with a specific implant to non-coverage for the LADR procedure for the Medicare population over sixty years of age. For Medicare beneficiaries sixty years of age and under, there is no national coverage determination, leaving such determinations to be made on a local basis.”

Further reading:

• CMS decision memo for Lumbar Artificial Disc Replacement
• Evaluating artificial disc replacement surgery

Posted by: Sylvia