Independence Technology has filed for a National Coverage Determination (NCD) with the Centers for Medicare & Medicaid Services (CMS) on behalf of its famous stair-climbing iBOT power wheelchair, an Independence Technology spokesman said.
In response, CMS has opened a 30-day public comment period starting Jan. 26, 2006, according to documents posted on CMS’ Web site.
The iBOT power chair, with gyroscopic technology that enables it to rise and balance on two of its four wheels, is in its second incarnation: The iBOT 4000 was introduced last year to replace the original iBOT 3000. The iBOT is currently sold directly to consumers following assessment and training by rehab clinicians. In addition, the Food & Drug Administration’s (FDA) original approval of iBOT carried with it certain restrictions and user criteria, including a user weight of no more than 250 lbs., the ability of the user to use a standard footrest and sit upright in a standard wheelchair, functional use of at least one arm and no need for a ventilator or pressure relief via tilt or recline positioning systems.
Lead CMS analyst Linda Smith confirmed that Independence Technology has “followed the NCD criteria process, and we reviewed the application. Our next step — which is where we are — was to post a tracking sheet for public comment. They followed all the procedures, to make sure they had all the evidence to support it (the NCD request).” Smith said CMS is now waiting for public comments: “A lot of times through the comments, we may get additional research (as) different groups provide comments.”
To see the coverage documents for the iBOT 4000, go to www.cms.hhs.gov/mcd/ncpc_view_document.asp?id=5.