Guest guest Posted March 27, 2002 Report Share Posted March 27, 2002 Tim - I have an insurance question for you. I posted this on Sunday and it never appeared! Sorry if it eventually comes up there. Our insurance (UHC)denied us because our policy doesn't cover othotics. According to an article you wrote that I got at StraightAhead, the DOC Band isn't considered a Class III orthotic by the FDA, but a Class II " neurology device. " Am I interpreting this correctly? I want to stick it to these turkeys and want to make sure I am understanding this correctly. We have a " face to face " appeal within the next 30 days sometime. Are there any other articles you would suggest taking? BTW, thanks to all the Cranial Tech folks for making this band. I truly believe you have improved the quality of Dane's life. TIA, Dane's mom (DOC Band 2/14) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 27, 2002 Report Share Posted March 27, 2002 Dear Tia, The generic name for devices used in the treatment of plagiocephaly is 'cranial orthosis'. While called an orthosis, the panel at the FDA that has jurisdiction over its regulation is the neurology division. This has been published in the Federal Register Vol 63. No. 146 (Medical Devices, Neurological Devices, Classification of Cranial Orthosis). You may get a copy of this for your insurance company off of our website (www.cranialtech.com) under the 'Information Center', or email me your address and I will send one out. You may also confirm this information at the FDA's website as follows: 1. www.fda.gov 2. Click on the Medical Devices link on the left hand side. 3. From the first drop down menu box on the left (I believe its called favorites or something like that) select CDRH Databases. 4. About 3/4 of the way down the page click on the link called Searchable 510(k)/Premarket Notification Database. 5. A search form comes up. Under the prodcut code, type in MVA (the product code for the cranial orthosis). This will list all manufacturers that have been cleared for market (15 or so I believe). By clicking on any of those, I believe a pop-up window with the Federal Register comes up. The above was from memory, so if I wasn't clear, or you get stuck, drop me an email. Thanks, Tim > Tim - > I have an insurance question for you. I posted this on Sunday and > it never appeared! Sorry if it eventually comes up there. > Our insurance (UHC)denied us because our policy doesn't cover > othotics. According to an article you wrote that I got at > StraightAhead, the DOC Band isn't considered a Class III orthotic by > the FDA, but a Class II " neurology device. " Am I interpreting this > correctly? > I want to stick it to these turkeys and want to make sure I am > understanding this correctly. We have a " face to face " appeal within > the next 30 days sometime. > Are there any other articles you would suggest taking? > BTW, thanks to all the Cranial Tech folks for making this band. I > truly believe you have improved the quality of Dane's life. > > TIA, > > Dane's mom (DOC Band 2/14) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 27, 2002 Report Share Posted March 27, 2002 Cool! Thanks Tim. You rock! Dane's mom sorry....i thought TIA meant thanks in advance! oops! > > Tim - > > I have an insurance question for you. I posted this on Sunday and > > it never appeared! Sorry if it eventually comes up there. > > Our insurance (UHC)denied us because our policy doesn't cover > > othotics. According to an article you wrote that I got at > > StraightAhead, the DOC Band isn't considered a Class III orthotic > by > > the FDA, but a Class II " neurology device. " Am I interpreting this > > correctly? > > I want to stick it to these turkeys and want to make sure I am > > understanding this correctly. We have a " face to face " appeal > within > > the next 30 days sometime. > > Are there any other articles you would suggest taking? > > BTW, thanks to all the Cranial Tech folks for making this band. I > > truly believe you have improved the quality of Dane's life. > > > > TIA, > > > > Dane's mom (DOC Band 2/14) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 27, 2002 Report Share Posted March 27, 2002 Oops, I thought you were TIA, Dane's mom. > > > Tim - > > > I have an insurance question for you. I posted this on Sunday > and > > > it never appeared! Sorry if it eventually comes up there. > > > Our insurance (UHC)denied us because our policy doesn't cover > > > othotics. According to an article you wrote that I got at > > > StraightAhead, the DOC Band isn't considered a Class III > orthotic > > by > > > the FDA, but a Class II " neurology device. " Am I interpreting > this > > > correctly? > > > I want to stick it to these turkeys and want to make sure I am > > > understanding this correctly. We have a " face to face " appeal > > within > > > the next 30 days sometime. > > > Are there any other articles you would suggest taking? > > > BTW, thanks to all the Cranial Tech folks for making this band. > I > > > truly believe you have improved the quality of Dane's life. > > > > > > TIA, > > > > > > Dane's mom (DOC Band 2/14) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 28, 2002 Report Share Posted March 28, 2002 In a message dated 03/27/2002 11:48:47 AM Central Standard Time, rmanias@... writes: << Cool! Thanks Tim. You rock! >> I'll second that!! Marci Quote Link to comment Share on other sites More sharing options...
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