View Full Version : FDA approval of CGMS?
Mama2H
03-15-2007, 05:20 PM
I posted this in glucose monitoring but know that more people look here.
Does anyone have the link to the FDA approval for the minimed CGMS in children? My insurance just called and said that it is still "experimental" and they won't cover anything experimental I have been calling them constantly asking them and they kept telling me as long as we have the letter of medical nec it would be covered but now they are backstepping big time Any links with approval or showing that it is no longer experimental will be of great help!!!
Amy C.
03-15-2007, 05:29 PM
http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1173705787522&lang=en_US
Mama2H
03-15-2007, 05:30 PM
Thank you Amy. I sent that one already but they want something directly from the FDA :(
Reagan's Mama
03-15-2007, 05:52 PM
Is this what you are looking for?
http://www.minimed.com/pdf/x22_fda_approval.pdf
Mama2H
03-15-2007, 06:00 PM
Close! They want something that says that it has been FDA approved in children. Thank you Amy :D (the other one lol)
Amy C.
03-15-2007, 06:07 PM
I searched the FDA site and could not find any announcement of this. Perhaps you could contact Minimed.
Ellen
03-15-2007, 06:27 PM
I don't believe it was approved for use in children yet.
Mama2H
03-15-2007, 06:28 PM
I just called minimed and they are looking up the info now and are going to forward it to my insurance! Thank you all so much.
Mama2H
03-15-2007, 06:28 PM
According to Minimed it was approved for use in children on Monday.
Reagan's Mama
03-15-2007, 06:30 PM
If you happen to get a copy of it, or find it on the net, would you mind posting so that I can copy it too?
Minimed is going to work with me for insurance approval, but I would like to have it for ammo if needed.
Glad you found it!
Mama2H
03-15-2007, 06:36 PM
I sure will! My insurance is trying to say that it is still experimental as this is the only way they can deny covering it according to our insurance policy since we have the letter of medical nec. Before they got the actual $$ amounts they kept telling me it was definatly covered as long as I had that letter. I figure once they saw they expense of it they were a bit shocked and are looking for a way out of covering it.