Blue Cross and Blue Shield of Kansas (BCBSKS) considers the DeNovo NT Natural Tissue Graft by Zimmer to be considered experimental/ /investigational (E/I).

This determination was reached based on the following:

• DeNovo NT Graft Natural Tissue Graft by Zimmer Inc, is another application for cartilage regeneration using minced donated juvenile (< 12 years of age) fresh allograft cartilage tissue obtained from human cadavers. During implantation, the minced cartilage tissue is mixed in a fibrin glue adhesive. This cartilage-fibrin construct is then implanted into the defect with an additional thin fibrin adhesive layer. Because of the minimal manipulation of the tissue, DeNovo NT Graft is classified as a 361hTC/P product not requiring FDA premarket approval. An observational prospective trial to study the outcome of the DeNovo NT Graft procedure began in 2006 and is still recruiting participants. Randomized trials comparing this technique with standard methods have not been published and further studies of this technique are needed to establish its safety and durable outcome benefit.

The DeNovo NT Graft Natural Tissue Graft is currently in a Clinical Trial  and is considered E/I.  BCBSKS recommends that the provider submits a signed Limited Patient Waiver (LPW) by the member if services, which are considered E/I, are provided to the member.

If you have questions regarding this newsletter, please contact your BCBSKS Provider Representative.

Hospitals in Southern KS

Denny Hartman - 1-316-269-1602

Hospitals in Northern KS

Cindy Garrison - 1-785-291-8862

Ancillary Providers

Christie Blenden - 1-785-291-8813

cw