FDA Class !! prescription requirement for CPAP Mask

General Discussion on any topic relating to CPAP and/or Sleep Apnea.
mjrodr
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by mjrodr » Sat Jul 04, 2020 10:10 am

Pugsy wrote:
Sat Jul 04, 2020 9:54 am
...if complete mask packages didn't require a RX there is a really good chance insurance wouldn't pay.

....but unless the prices dropped dramatically (which I doubt) it could be a deal breaker for a lot of people.
I understand your point and, considering the big picture, do take it into consideration. Our free market is supposed to benefit everyone especially the customer. Of course, in the real world, this is not always the case. However, current practices, some mentioned above in my previous post, keep medications and medical supplies at inflated costs. Take the rising cost in such items as the epipen scandal. Lower costs through real competition not only benefits the patient, but also the insurance company. Monopolies keep costs high by eliminating competition.

HairyReasoner
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by HairyReasoner » Sat Jul 04, 2020 1:32 pm

mjrodr wrote:
Fri Jul 03, 2020 11:08 am
Hello and thank you in advance,

I am a veteran and the V.A. conducted my sleep study years ago. I was diagnosed and provided with a cpap machine as well as the basic supplies. I am currently trying to purchase a new mask from cpap.com and was surprised to learn that I needed a prescription to complete the order. I can understand requiring a prescription for a machine, but not for masks. This seems to be an unnecessary burden. I can purchase a syringe without a prescription, but not a mask with a hose attachment. I have contacted V.A. and after much time they are snail mailing me my prescription. I contacted my V.A. primary care and requested an online copy they have not yet responded.

I have searched online for the rational in classifying masks as Class II and could not find any real information. Is this a scenario where medical equipment suppliers or perhaps those that provide sleep studies lobbied congress and the FDA for this classification? Is this a scenario such as optometrists not providing you with your pupillary distance so that you cannot purchase less expensive glasses online? Or perhaps a scenario like the glasses where they are all practically owned by the same company thus creating a monopoly and being able to charge whatever they want?

Is there a petition or a group I can join to advocate in removing cpap masks from said classification?

Thank you again
I agree. I haven't seen an argument yet why the masks need a prescription. It is also somewhat pointless because it is easily circumvented by buying mask kits, which many online sellers carry. Those don't need a prescription, and it just takes seconds to snap a couple parts together and attach the headgear. You take it apart and put it back together every day to clean it, anyway.

But, if you want your insurance to cover it you'll need a prescription anyway.

mjrodr
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by mjrodr » Sat Jul 04, 2020 2:08 pm

HairyReasoner wrote:
Sat Jul 04, 2020 1:32 pm


But, if you want your insurance to cover it you'll need a prescription anyway.
Government bureaucracy mixed with corporate insurance... what a nightmare. The V.A. covers most of my medical needs (thank goodness). In my case I am willing to pay out of pocket, but I can't do that without a prescription. If I were to purchase a kit I would be paying about 3 times more than the current price due to the current offer of multiple pillows for full face masks to try for best fit, and that price is currently out of my budget. I'm currently in a holding pattern without being able to use my CPAP.

I realize for most this is not an issue, and that the status quo is just fine for many, but I am certain that I am not the only one who is having issues with this classification for masks.

Again, I thank all of you for your responses and advice.

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Dog Slobber
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by Dog Slobber » Sat Jul 04, 2020 2:11 pm

HairyReasoner wrote:
Sat Jul 04, 2020 1:32 pm
I agree. I haven't seen an argument yet why the masks need a prescription.
One was just posted.
Pugsy wrote:
Sat Jul 04, 2020 9:54 am
if complete mask packages didn't require a RX there is a really good chance insurance wouldn't pay.

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palerider
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by palerider » Sat Jul 04, 2020 2:29 pm

mjrodr wrote:
Sat Jul 04, 2020 9:08 am
The way I got around the system is to purchase my own device (same one as most optometrists use) and get our own distance.
One doesn't need a "device", one only needs a dry erase marker, and a pair of glasses.

http://www.daniellivingston.com/2012/06 ... tance.html

While you're at it, would you like to gripe about anything else that we have absolutely no control over?

If you want the answer to your questions, go ask the FDA.

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mjrodr
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by mjrodr » Sat Jul 04, 2020 2:31 pm

Dog Slobber wrote:
Sat Jul 04, 2020 2:11 pm


One was just posted.
Yes, you are correct, but that would be a separate issue. That would involve insurance companies profits and our current health care system. Researching this topic online I have found that the ACA is of great benefit to those who suffer from sleep apnea, especially when it comes to what insurers must cover.

I am now curious, if I needed a respiratory drug and that drug was covered by medical insurance, would the delivery system of that drug not be covered? For example, an inhaler not covered but the asthmatic drug is? I was able to find information on diabetics and syringes, as I found out that you do not need a prescription for a syringe, and what insurance currently covers on their part.

So far this is what I found:
Will my insurance cover my diabetes supplies?
ANSWER

Diabetes is the sixth leading cause of death in the U.S. And it is estimated that it costs the nation $170 billion annually. As a result, 46 states have mandated that insurers must cover diabetes medicine, supplies, and equipment. But you may have to engage in a letter-writing campaign to get your health insurer to pay for certain medical devices. Also, if you're on Medicare or Medicaid, you can check online to see if these government programs will reimburse you for diabetes supplies.
https://www.webmd.com/diabetes/qa/will- ... s-supplies

and interestingly...

The use of an insulin syringe by a diabetic would not meet the requirements of §1861(s) (2) (A) of the Act
https://www.uhcprovider.com/content/dam ... yringe.pdf

mjrodr
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by mjrodr » Sat Jul 04, 2020 2:34 pm

palerider wrote:
Sat Jul 04, 2020 2:29 pm
mjrodr wrote:
Sat Jul 04, 2020 9:08 am
The way I got around the system is to purchase my own device (same one as most optometrists use) and get our own distance.
One doesn't need a "device", one only needs a dry erase marker, and a pair of glasses.

http://www.daniellivingston.com/2012/06 ... tance.html

While you're at it, would you like to gripe about anything else that we have absolutely no control over?

If you want the answer to your questions, go ask the FDA.
I did write the FDA, and am waiting for a response, thank you. If you want me to go somewhere else to have a conversation about this topic I suggest that you not read my posts or this thread.
Thanks

tomkatt
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by tomkatt » Sat Jul 04, 2020 2:40 pm

I don't know if every site requires a prescription. I recently (like 2-3 weeks ago) bought a Brevida mask from cheapcpapsupplies.com and didn't need one. They required a prescription for CPAP machines but not masks. I also tend to buy my Dreamwear mask parts at Amazon, no prescription needed there either.

YMMV though. I pay out of pocket for everything and don't go through insurance. I'm not sure if insurance payout would be impacted by prescription/non-prescription purchasing.

-----

Edit here we go: https://www.cheapcpapsupplies.com/no-pr ... n-required

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HairyReasoner
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by HairyReasoner » Sat Jul 04, 2020 3:15 pm

Dog Slobber wrote:
Sat Jul 04, 2020 2:11 pm
HairyReasoner wrote:
Sat Jul 04, 2020 1:32 pm
I agree. I haven't seen an argument yet why the masks need a prescription.
One was just posted.
Pugsy wrote:
Sat Jul 04, 2020 9:54 am
if complete mask packages didn't require a RX there is a really good chance insurance wouldn't pay.
It's a needed accessory for a prescribed device, so I don't see why they wouldn't pay. I can buy mask cushions and parts without a prescription. I only need a prescription if I want to have insurance cover them. But a prescription isn't legally required for me to purchase them out of my own pocket. I don't see why purchasing the full mask can't be the same way.

mjrodr
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by mjrodr » Sat Jul 04, 2020 3:25 pm

HairyReasoner wrote:
Sat Jul 04, 2020 1:32 pm
But a prescription isn't legally required for me to purchase them out of my own pocket.
Thanks for the reply. I am paying out of pocket. cpap.com (they also host this website) are the ones that informed me of this requirement, and after preliminary research a prescription is required to purchase a mask, but as many have pointed out the mask parts can be purchased separately without prescription. If it wasn't for my seemingly never ending quest to find a mask that does not leak and that I can sleep through the night with I would use the work around loophole for myself. Either way though, wrong is wrong.

I just performed a search on this site for two words:

Insurance returned 64,847
and
Prescription returned 28,461

While these numbers do not scientifically prove anything they do indicate a commonality within the sleep apnea community.

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Dog Slobber
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by Dog Slobber » Sat Jul 04, 2020 4:11 pm

mjrodr wrote:
Sat Jul 04, 2020 3:25 pm
I just performed a search on this site for two words:

Insurance returned 64,847
and
Prescription returned 28,461

While these numbers do not scientifically prove anything they do indicate a commonality within the sleep apnea community.
I just did a search for the word "boobs", returned 154 hits.

The significance of what that means seems undeniable..........

mjrodr
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by mjrodr » Sat Jul 04, 2020 4:16 pm

Dog Slobber wrote:
Sat Jul 04, 2020 4:11 pm

I just did a search for the word "boobs", returned 154 hits.

The significance of what that means seems undeniable..........
Not sure what you are implying....


boob
noun
a stupid person; fool; dunce.
https://www.dictionary.com/browse/boob

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zonker
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by zonker » Sat Jul 04, 2020 4:24 pm

mjrodr wrote:
Sat Jul 04, 2020 4:16 pm
Dog Slobber wrote:
Sat Jul 04, 2020 4:11 pm

I just did a search for the word "boobs", returned 154 hits.

The significance of what that means seems undeniable..........
Not sure what you are implying....


boob
noun
a stupid person; fool; dunce.
https://www.dictionary.com/browse/boob
"boobs" he said, not "boob".

boobs are a woman's breast-
https://www.urbandictionary.com/define.php?term=Boobs
people say i'm self absorbed.
but that's enough about them.
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mjrodr
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by mjrodr » Sat Jul 04, 2020 4:27 pm

zonker wrote:
Sat Jul 04, 2020 4:24 pm

"boobs" he said, not "boob".

boobs are a woman's breast-
https://www.urbandictionary.com/define.php?term=Boobs
Oh, I see, they come in pairs.

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chunkyfrog
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Re: FDA Class !! prescription requirement for CPAP Mask

Post by chunkyfrog » Sat Jul 04, 2020 6:30 pm

Mine are technically "foobs", false boobs.
They are well-behaved, not attempting frogicide, (like the real ones)
not sagging or bouncing excessively,
but they will dance on cue.

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