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CMS Opens National Coverage Decision For Synthes’ Lumbar Disc

This article was originally published in The Gray Sheet

Executive Summary

Six months after issuing a limited national coverage decision for Johnson & Johnson/DePuy's Charité artificial lumbar disc, CMS says it will take a fresh look at data for newly approved lumbar discs

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With Medicare Coverage Policy Pending, Blue Cross Finds Fault With ProDisc

A recent negative assessment of lumbar artificial disc replacement by Blue Cross Blue Shield could spell trouble for Synthes as it seeks full Medicare coverage for ProDisc

With Medicare Coverage Policy Pending, Blue Cross Finds Fault With ProDisc

A recent negative assessment of lumbar artificial disc replacement by Blue Cross Blue Shield could spell trouble for Synthes as it seeks full Medicare coverage for ProDisc

Long-term data on Charité

The vast majority of 106 patients implanted with Johnson & Johnson/DePuy's Charité lumbar artificial disc at one center in France continue to have positive results 10 to 16 years post procedure, and 42.5% report "excellent" long-term outcomes, according to a study published March 15 in Spine. The author of the retrospective study, Thierry David, M.D., Polyclinique de Bois-Bernard, notes a considerable reduction in transition syndrome, or adjacent level disease, in the study population compared with historical data on lumbar fusion. Charité has been available in Europe since 1987. Since its U.S. approval in 2004, payors have criticized the robustness of data on the procedure, including a lack of long-term follow up (1"The Gray Sheet" Dec. 4, 2006, p. 9)...

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