Medicare has finally approved coverage for lumbar charite--for patients under the age of 60. A huge development.

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From the CMS website...not exactly a straight up approval of Charite for those under 60 but at least it's not a flat out denial either. I would love to test my local SSD office except that I was told that they are 2 yrs behind schedule hearing appeals!

SUBJECT: Coverage Decision Memorandum for Lumbar Artificial Disc Replacement
DATE: May 16, 2006

I. Decision

The Centers for Medicare and Medicaid Services (CMS) has found that lumbar artificial disc replacement (LADR) with the Charite lumbar artificial disc is not reasonable and necessary for the Medicare population over sixty years of age. Therefore, we are issuing a national noncoverage determination for LADR with the Charite lumbar artificial disc 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.
***
Conclusions

Chronic back pain from degenerative disc disease is complex and can be difficult to treat. Current surgical treatment modalities are controversial. After thoroughly reviewing the existing data for LADR with the Charite lumbar artificial disc, important questions remain regarding patient selection, adverse events, and long term outcomes. The Charite PMA trial was limited to patient ages 18 to 60 years old, excluding the age group with the highest prevalence of degenerative disc disease. Due to the lack of evidence of benefit for those Medicare beneficiaries over the age of 60, CMS will noncover LADR with the Charite lumbar artificial disc in this population.

Some evidence does exist for patients 60 years of age and under, though the results of the Charite PMA noninferiority trial are unconvincing as an adequate demonstration of health benefit and do not provide a sufficient basis for a NCD at this time. The Charite studies without a comparison group make it difficult to draw clear conclusions on the benefit of treatment, though some individual patients with this complex, potentially disabling problem may benefit. This makes it difficult for CMS to arrive at an appropriate conclusion as to whether this device is reasonable and necessary for the 60 years of age and under Medicare beneficiary. In our proposed decision memorandum released on February 15, 2006, CMS proposed noncoverage for all Medicare beneficiaries. In consideration of the difficulty in arriving at a clear conclusion of the benefit of this technology for the 60 years of age and under population, along with the strong opinion from the public about the complicated nature of appropriate patient selection and the need for some limited coverage, we are changing our proposed decision and removing the national noncoverage for this segment of the Medicare population. Therefore, for Medicare beneficiaries 60 years of age and under, we will continue current coverage at this time.

There is clearly a tremendous need for additional research on the treatment of degenerative disc disease to include the technology addressed in the NCD—the lumbar artificial disc—and other surgical procedures to include spinal fusion. Therefore, CMS will also convene a Medicare Coverage Advisory Committee at the earliest possible time to address the issue of spinal surgery for degenerative disc disease. We urge the spinal surgery community to discuss the current limitations of the evidence for benefit and to outline the steps needed to develop better evidence.

CMS is aware that there are several other disc technologies in FDA investigational device exemption clinical trials in the United States. As previously stated, CMS is evaluating LADR with a focus on the Charite lumbar artificial disc in this analysis, since this was the only disc implant that had FDA approval at this time. However, we anticipate that when other lumbar spinal disc implants receive approval from the FDA that CMS will, by external request or internal direction, open this NCD for reconsideration with a thorough review of the evidence for each new disc implant. 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.

NIce to see good news for a change! At least Medicare does recognize that this could benefit their subscribers under the age of 60 and I hope that this is the first step to getting better coverage from the private sector in paying for the device and the procedure!

This is good news, altho because I've WC coverage, Medicare doesn't cover anything for my low back~ but it's good to know that it may cover this for others.

Hopefully MC will eventually go on a case by case coverage for those over 60 who may be in better physical health than some under 60!

It's a start~ thanks Barbara for posting this~

I think this is great news for Medicare beneficiaries under 60, and maybe even over 60. They are leaving the door open, which to me is interpreted that they don't want to admit that they were wrong. It's like a person/company who is being sued, and settles but denies any wrongdoing.

Unfortunately for me I had a lumbar fusion 3 months ago so I am not helped by this unless the level above herniates and then I will insist on a disk one level above!

LBP Thanks for posting this!