Anthem: Barricaid®, XcloseTM, DART annulus closure after discectomy, late 2012
 

Anthem Insurance considers annular closure as investigational and not medically necessary.


Anthem Coverage Position

Anthem mentions:
Barricaid®
Disc Annular Repair Technology (DART) System
XcloseTM Tissue Repair System (anulex)


The 2012 German Spine Congress had several abstracts on annular closure devices, most positively reviewed. see http://www.adrsupport.org/forums/f45...-2012-a-11828/ .

If a patient wants to petition Anthem for coverage, please consider citing the 2012 German Spine Congress document. I have not seen the prospective studies listed in the European Spine Journal.

Anthem provided the below citations, "peer reviewed publications", and Anthem published April 2012. The below items are prior to the publication of the German Spine Congress. The Bron, Helder, Meisel 2009 article mentions annular closure, however it does not bring up any multi-arm prospective trials noted in the German Spine Congress.


Anthem ->


Peer Reviewed Publications:

1. Ambrossi GL, McGirt MJ, Sciubba DM, et al. Recurrent lumbar disc herniation after single-level lumbar discectomy: incidence and health care cost analysis. Neurosurgery. 2009; 65(3):574-578.
2. Bron JL, Helder MN, Meisel HJ, et al. Repair, regenerative and supportive therapies of the annulus fibrosus: achievements and challenges. Eur Spine J. 2009; 18(3):301-313.
3. Sherman J, Cauthen J, Schoenberg D, et al. Economic impact of improving outcomes of lumbar discectomy. Spine J. 2010; 10(2):108-116.

Government Agency, Medical Society, and Other Authoritative Publications:

1. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Xclose Tissue Repair System, Model SRS. Summary of Safety and Effectiveness. No. K062307. Rockville, MD: FDA. September 1, 2006. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=22394. Accessed on December 21, 2011.

I may/probably have soft-copy of items #2 and #3 above, not #1 McGirt.