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The Centers for Medicare and Medicaid Services (CMS) issued their much-anticipated Proposed Decision Memo for the ProDisc®-L Total Disc Replacement last Friday.

Click here to link to the decision.

CMS determined that the Lumbar Artificial Disc Replacement (LADR) procedure is not reasonable and necessary for the Medicare population older than 60 years of age. Therefore, CMS is proposing that its previous noncoverage decision for the Johnson & Johnson Charité device be amended to include all LADR procedures for the Medicare population over older than 60 years of age. For Medicare beneficiaries 60 years of age and under, there is no national coverage determination, leaving such determinations to be made on a local basis.

CMS said, “In our review of the literature, we were unable to find evidence that the theoretical mobility provided by the artificial disc directly correlates to a benefit in how the patient feels or functions, making the clinical significance of post treatment range of motion unclear. In addition, we are unable to identify any clinical evidence that supports the premise that segmental mobility prevents adjacent level disease. Therefore, CMS does not consider post treatment range of motion an important clinical outcome of interest in this memorandum.”

CMS also quoted a 2006 technical assessment report issued by Blue Cross Blue Shield (BCBS) that looked at the Charité disc.

“... the evidence is not sufficient to conclude that the use of artificial vertebral discs improves health outcomes.... The evidence is insufficient to determine whether the use of artificial vertebral discs improves net health outcome or whether they are as beneficial as any established alternative.” BCBS reaffirmed the decision that artificial lumbar disc for degenerative disc disease does not meet the Technical Evaluation Center criteria in March of 2007.

CMS discounted ProDisc’s randomized clinical trial, which was designed to demonstrate that the disc is not inferior to fusion, by saying, “it is not clear that a trial designed to demonstrate noninferiority is valid given that the effectiveness of fusion in degenerative disc disease is not well-established in comparison to no treatment.” In addition, they noted that, “no one over age 60 was included in the study.”

The preliminary decision also noted that, “A reliable diagnostic test to determine the exact cause of low back symptoms has yet to be developed, so it is difficult to differentiate between possible sources. Treatment of symptoms relies primarily on a subjective measure—clinical judgment. Though the evidence base for conservative treatment is weak, the majority of patients with low back pain will have acceptable results without surgery.... No universally accepted indication guideline exists to assist the physician in patient management.”

CMS concludes that, “Due to the lack of evidence of benefit for those Medicare beneficiaries over the age of 60, CMS proposes to noncover LADR in this population.”

The agency is requesting public comments on this proposed determination. They are particularly interested in comments that include evidence they did not review or that assess how they evaluated the evidence included. After considering the public comments and any additional evidence, CMS will make a final determination and issue a final decision memorandum..

To send your comments to CMS, go to this link.

We will provide a more detailed analysis of the CMS decision in the June 5th issues of Orthopedics This Week.