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Tim L. - Insurance question

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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)

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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)

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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)

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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)

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