Link to FDA approval?

[Mama2H]

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!!!

[rickst29]

http://www.fdanews.com/dailies/device/3_52/news/67286-1.html

it's a 3rd-party "tracking" company's article, but that should be sufficient for the APPROVAL. Still, insurance often continue to label Approved drugs and devices "expermental" for as a long as they can get away with it, and continue to deny coverage for a long time after they've been approved. So you're probably gonna need lots more more documentation and ammunition than you think. (Approval by itself almost certainly WON'T enough for them to agree to coverage.) Right now, many companies are refusing to cover either of the approved CGMS devices for CGMS for adults, claiming that they're still "experimental" (even though Dexcom was approved for adults almost an entire year ago, and the Minimed R/T was approved several months before that).

The MOST important thing is documentation for your child's dangerous glycemic excursions (highs and lows, but ESPECIALLY lows). Lows severe enough to need EMT or ER intervention are especially relevant. But the main thing is, don't let them get into a paper fight about studies on other people: focus on showing an 'obvious' medical necessity for you, and you can probably win. (You'll need a stack of references to studies anyway, but you have to prove your individual and manifest for the device FIRST.)

This is extremely difficult to win in advance, before you have any proof that the device REALLY saves your child from dangerous bG excursions. Most parents who have won coverage bought the gadget first, established a track record of important hypo detections, and then successfully appealed for coverage (in some cases retroactive) AFTERWARDS.

[Mama2H]

THANK YOU!! I am forwarding that to my insurance right now :D

[rickst29]

http://health.groups.yahoo.com/group/diabetescgms/

[mom2jjm]

http://www.minimed.com/help/forms.html

Here is the link to the FDA approval letter posted on the minimed site. Look at the bottom of the page.

The page also gives other info. about getting insurance coverage. Good luck and keep us posted!

[Mama2H]

I just got the call!!!!!!!!!!!!!! WE ARE APPROVED :D I am sitting here trying not to cry. I sent them all of the info I could find yesterday and I guess they gave in right away :D

[mom2jjm]

That is absolutely awesome! I am so happy for you. It gives the rest of us hope.

[Mama2H]

Melissa, pm me! I think you are near Sioux City right? We have started a support group that meets in Sioux City. I could be wrong on the location though *blush*

[Budapest]

Cool. Go you. Did they approved both the transmitter and the regular supply of sensors?

May I ask which insurance this is?

[Mama2H]

When I asked them if the are covering the CGMS they said yes, asked if that was everything and she said yes. I am assuming that means the sensors also. We have First Administrators for insurance.