FDA Class !! prescription requirement for CPAP Mask

[mjrodr]

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


-------------------------------------------------------- Update below -----------------------------------------------
My last post on this thread is copied here below:

Hello CPAP.COM - Since you host this website I would assume that you also moderate it, and if you do you must also be supporting your resident troll. I said my peace, I was polite, and most of all was hoping to find support among fellow sleep apnea sufferers. I would think that lowering costs and addressing bureaucratic hurdles many of us face would be relevant topic of discussion. What a shame. This will be my last post here as I do not feed trolls nor do I like being insulted by them.

Good luck and thank you

[Wulfman...]

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

Please fill out your profile! That way we'll know what you're using.

Apparently, the prescription has ALWAYS been a requirement for masks, but back in about 2009, CPAP.COM and other online sellers were forced to enforce that requirement for filling mask orders. (manufacturers were threatening them)
HOWEVER...................
There are several ways of getting around it:
One is to buy mask "kits".
Another is to buy replacement mask parts.
Another is to buy masks from non-DME sources......like individuals selling them on this forum.
Prescriptions only apply to DME-Class vendors AND "complete" masks. That's why the "kits" are exempt.
If your sleep doctor balks at writing another Rx, contact your family physician, dentist or some others listed in the second link below.

https://www.cpap.com/plp/cpap-mask-kits/ZT0zMzI

https://www.cpap.com/cpap-faq/Prescriptions

And, make sure your prescription is one that doesn't expire.

Here's the link to the policy change:

viewtopic.php?f=1&t=43295&p=383331&hili ... ns#p383331


Den

.

[ChicagoGranny]

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?

1. No
2. No
3. No

It was just an FDA committee that wrote the damn requirement the way most government bureaucracies write requirements. It's easy to write a government requirement, but try getting rid of one that doesn't make a lick of sense - impossible.

[Chris8243]

Interesting questions. I have no idea about why an Rx is required for masks. I've bought some supplies on Amazon but I have insurance and most things are less out of pocket if I use a DME.

I'm also wondering why you couldn't get a copy of your eye exam results to buy glasses (or contacts) somewhere else? Is it because of VA requirements? I haven't ever had an issue with that. I just ask for a written Rx when I'm leaving after an eye exam.

[ChicagoGranny]

I'm also wondering why you couldn't get a copy of your eye exam results to buy glasses (or contacts) somewhere else?

Scripts rarely include --->

such as optometrists not providing you with your pupillary distance

[Okie bipap]

I have purchased complete masks and mask parts on eBay. You can also purchase masks on Amazon where many suppliers do not require a prescription. While DMEs require a prescription to purchase a complete mask, you can purchase a mask kit (frame and cushion) and a head gear seperatly for the same price. The only problem with this is you normally cannot return a mask kit and head gear combination if you don't like it. If you have a dentist you see regularly, ask him or her to write you a prescription for a mask. Once you get one, make a copy of it and keep it for future use.

[Pugsy]

I'm also wondering why you couldn't get a copy of your eye exam results to buy glasses (or contacts) somewhere else?

Scripts rarely include --->

such as optometrists not providing you with your pupillary distance

Actually mine did provide pupillary distance and I used it to order eyeglasses online and saved tons of money.

But if it didn't....I would have just asked. They have to supply it if requested.

[Goofproof]

You, like I are a Vet, and you haven't figured out how dealing with the government works, shame on you. I knew how the government worked, even before I was Drafted. I was a Mechanic, then I was drafted, Sent me to Fort Ord in Calif for training as a wheeled vehicle mechanic, on 105 How self propelled, stayed there two hours, was taked back to HQ, for OJT training as a morning report clerk for three month, then sent to Viet Nam as a PFC as a mechanic, I hadn't even drove a military truck yet, good news I got my own M35A2 Multi Fuel 2 1/2 ton truck with trailer and a New M-14 A1 semi auto rifle 7.62mm, which I promptly converted jnto a M14A2 Full Auto.

Good thing I knew how our government worked. Even so they kept me learning.
Jim

Even at my age I learn something every day, my one problem is not being to put some things out of my mind.







'

[chunkyfrog]

About the pupillary distance being left off your prescription--
Just ask the optometrist to add those numbers.
They cannot legally refuse, but often try to protect their business.
The glasses monopoly is a real thing, but competition is rising.
Online dealers and Costco will sell non-syndicate supplies.

[mjrodr]

Thank you all for your replies. Please allow me to address some of the questions and clarify my issue.

For those replying to my pupillary distance claim. There are only 2 states that have laws requiring optometrists to provide pupillary distance to patients. They all must provide you your prescription, but do not have to give you your pupillary distance (a requirement for creating your glasses).

For those claiming just ask, believe me I have. Many will not and refuse to do so as it effects their bottom line. This is a rather big issue and information on it is available readily online.

I thank everyone for their advice on how to get a mask without a prescription. I am aware of these options. I like to purchase new equipment and while the customer service agent from cpap.com mentioned the purchase in parts option it would not be ideal for me. For one, the item I was purchasing came with 4 different size pillows for a full face mask and had a return guarantee. I opted for this order to find the best fit for me (years of dealing with the same type of ill fitting mask). Furthermore, their would be no return option on separate broken down purchases.

To my fellow Vet, of course I understand how the military works, hurry up and wait has not, and will never, change. When I was informed I needed a prescription I realized I would be in for a long haul.

After not being able to find any real answers online as to when and how masks became Class II devices I decided to reach out to the FDA myself. I am not certain if I will get a response but when and if I do I will post it here.

I am the type of person who speaks up when I believe there is an obvious wrong. If there currently is no petition or movement to change this policy I will be certain to create one and proactively advocate for a positive change. I understand that this may only amount to banging my head against the wall, but at least I will have tried, and I also have a pretty hard head.

Again, thank you all for your replies and considerations. They are greatly appreciated.

[ChicagoGranny]

For those replying to my pupillary distance claim. There are only 2 states that have laws requiring optometrists to provide pupillary distance to patients. They all must provide you your prescription, but do not have to give you your pupillary distance (a requirement for creating your glasses).

Right. My ophthalmologist, who is part of a large practice, charges $50 out of my pocket for the pupillary distances. I don't like their eyeglass store, so I just take the script across the street to a more reasonable store. They do the measurement for me when I order glasses from them. This store also has what we use to call "battle brands" frames. They won't tell you about them unless you ask. Then they pull them out of a drawer behind the counter. These are unbranded frames. You can get the frames and lenses as cheap as Costco. And, they are every bit as good and fashionable as the name-brand frames.

[ChicagoGranny]

They have to supply it if requested.

In my state of residence, they are not required to provide pupillary distances. My ophthalmologist wants to charge $50 out of my pocket. I beat this scam - see my post above.

[mjrodr]

They have to supply it if requested.

In my state of residence, they are not required to provide pupillary distances. My ophthalmologist wants to charge $50 out of my pocket. I beat this scam - see my post above.

My wife, my four children, and myself, all wear glasses. I have encountered this issue many times and am working with others to petition the state to address this monopolization and impediment on healthcare. The way I got around the system is to purchase my own device (same one as most optometrists use) and get our own distance. However, there should not have to be this type of workaround for something that should be provided by your eye doctor (most are working for, or are indebted to, the company that makes most glasses and has a monopoly on them, in this case luxottica).

[mjrodr]

So, as it is a holiday I have some time to do a little research on this topic. So far, here is what I found.

First of all, I would like to thank cpap.com for providing this venue for such a discussion. I sincerely hope that it can continue and from my email interactions with your customer service reps I believe it will. https://www.cpap.com/aboutUs



I am not a conspiracist, but there are some readily available facts that, after some consideration, call for further inquiry on my part. I was not certain as to who benefits from this Class II labeling, but as most things decided to research financial gains (follow the money) to find an answer.

This is what I found so far:

1. Premarket Approval in the medical community is used by some to monopolize their industry and reap financial profits at the costs of patients.
https://www.cbsnews.com/news/how-the-fd ... onopolies/

https://www.independent.org/publication ... sp?id=1227

https://legacy-uploads.ul.com/wp-conten ... _v5_HR.pdf


2. ResMed Corp., a manufacturer of durable medical equipment (DME) based in San Diego, California, has agreed to pay more than $37.5 million to resolve alleged False Claims Act violations for paying kickbacks to DME suppliers, sleep labs and other health care providers, the Department of Justice announced...

https://www.justice.gov/opa/pr/resmed-c ... ed%20today.

[Pugsy]

The other side of the equation.....if complete mask packages didn't require a RX there is a really good chance insurance wouldn't pay.
A potential downside for a lot of people. Then the next step would be the replacement parts wouldn't be a covered expense either.

Don't get me wrong...I also think it is a stupid law. I can't think of one way a cpap mask could be abused and who in their right mind would fork over the dollars for one without actually needing it....but unless the prices dropped dramatically (which I doubt) it could be a deal breaker for a lot of people.