FDA petition to grant OTC status to CPAP machines

I just stumbled across this Citizen Petition:
www.regulations.gov/document/FDA-2024-P-2242-0001

Here is a link to the letter making the request:
https://downloads.regulations.gov/FDA-2 ... ment_2.pdf

Hearing aids have been deregulated, and so should CPAP machines.

I added a comment in support of this, here:
https://www.regulations.gov/commenton/F ... -2242-0001

I'm sure more comments will help!

How will these people get their OTC machines set to what the RX should be?

Will they be expected to do the set up themselves?

Trump will place a 200% tariff on CPAP machines, and later, RFK Jr. will outright ban them.

gotaug2 wrote: ↑

Thu Mar 13, 2025 1:01 am

I added a comment in support of this, here:
https://www.regulations.gov/commenton/F ... -2242-0001

I'm sure more comments will help!

CPAP machines and supplies will no longer be covered by insurance. Are you going to lead a gigantic fundraiser to buy CPAPs for people who can't afford them without insurance help?

My favorite part of the letter:
"Require that sellers of CPAP machines provide instruction manuals written at the 6th grade level of reading ability and illustrations of the set up.".

Almost everyone who needs the documentation to be at grade 6 level, with pictures, should not be setting up their CPAPs.

Dog Slobber wrote: ↑

Thu Mar 13, 2025 10:02 am

My favorite part of the letter:
"Require that sellers of CPAP machines provide instruction manuals written at the 6th grade level of reading ability and illustrations of the set up.".

Almost everyone who needs the documentation to be at grade 6 level, with pictures, should not be setting up their CPAPs.

I worked with a fellow once who in a previous career was a document writer. he worked for some corporation who's name escapes me now. he said that when he finished a draft, he'd take it down to the "secretarial pool" (yeah, I know. it was a different time.) for them to read if. if they couldn't understand it, he'd do a re-write, dumbing it down.

dunno if he was just being misogynistic or if it really helped him.

Regarding the concer that insurance would stop covering CPAP:
Plenty of things like wheelchairs and other durable medical equipment don't require prescriptions and are still covered by insurance.

The important thing is that all CPAP users would benefit, independent of their insurance coverage.

Right now, Resmed has almost a monopoly position in the USA.

Competition could easily bring prices for BiPAP down below most people's current deductible, in addition to driving innovation that would improve the therapy you received.

An Aircurve ASV ST-A costs Resmed the same to manufacture as their most basic fixed pressure model, the Airsense Elite.

Reliability has gone backwards between the Airsense 10 and Airsense 11 line, and Resmed is using the smaller, less capable, Airmini blower (from 8 years ago) in the Airsense 11 line, instead of something that is newer and better.

The sensors and algorithms used in Resmed's current models haven't been updated in eleven years!

Wouldn't it be nice for everyone to afford ASV that had been improved to keep ahead of the competition, while also costing less and being more reliable?

... And really, if you think CPAP is so complicated that higher than a 6th grade reading ability is necessary, then you're being a gate-keeper as much as the medical-industrial complex is.

How many doors would be opened, if the prescription requirement was removed from CPAP equipment?

I read the proposal. It makes sense. However as gotaug2 points out, I would want it still covered if you are willing to jump through the hoops of getting the medical people involved. But as a general rule, OTC is so much less bothersome when you know your problem, you know the fix, and the fix isn't inherently dangerous.

One of the benefits of keeping CPAP prescription only is the doctor gets reports of how you are doing, which helps him assess your risk of heart disease, etc. But as the petition states, maybe a lot of people are simply falling through the cracks entirely, whereas they might "self-treat" if it were OTC. And I suppose you can always collect the data and bring it to your doctor yourself, I think. Still not sure how the data thing works with these things. Do they need a DME to enable it? Nevertheless, going through a doctor keeps him in the loop, and maybe gets you to go to him in the first place.

The petition is a little over-the-top listing a bunch of catastrophes involving sleep deprived operators. The implication is they might have had sleep apnea, not been medically diagnosed, and if only they had thought to buy a CPAP OTC and self treat, these accidents would have been avoided. That's a bit of a stretch, and weakens his argument, though the basic idea is true; fatigue in general is responsible for a lot of society's ills, but not all fatigue is caused by OSA.

But when he says CPAP is "a fan that blows air" which is controllable by the user, it makes me say, "Wait! The government is forbidding a citizen to use a fan to blow a bit more air into himself than ambient conditions, unless he or his insurance pays a bunch of money to corporations and healthcare practitioners? What's the real motive behind that limitation of our freedom?"

We used to be able to buy heroin and cocaine OTC and I can sorta see why the government restricted that, but a fan blowing air into our nose? Heck, we can still inhale cigarette smoke all day long without permission from a doctor, but the government won't let us inhale slightly higher pressure clean air without nanny supervision?

Bottom line, some independent minded people would benefit from do-it-yourself CPAP and I think risk is virtually negligible (at least for CPAP and APAP. Maybe BiPAP has slightly higher risk and is more complex, and used more if you have comorbidities so maybe you'd want medical management for that.)

But also all of them should remain reimbursible via insurance for anyone who wants the medical establishment to oversee their treatment, or for whom cost is a factor.

Cake and eat it too, that's my position.

Are there any countries where a CPAP and associated supplies are presently offered as OTC?

When I was diagnosed with OSA and AFIB, I had never heard of either one.
I can now look back and recognize my OSA symptoms going back at least a decade or two or three prior to my diagnosis by a doctor.
I recognized OSA symptoms in my wife a decade before I convinced her to get tested. She now admits the only reason she finally agreed to the test was to prove to me she did not have OSA and get me off her back.
So, unless the PAP OTC manufacturers advertised as much as the drug manufacturers do now, most people would be as ignorant as I was.
I don't remember my father ever going to a doctor, until he was 60 years old in a diabetic coma. He never came home.

So first we would need to institute mandatory training of ALL MDs to recognize OSA symptoms and what PAP machines are and how they work.
Than you would need to convince every adult to get an ANNUAL physical at least once a decade.

After accomplishing all of the above, how would we convince the majority of people not to relegate their PAP machines to the same closet where their exercise equipment lives.

Grumpy48 wrote: ↑

Fri Mar 14, 2025 12:20 pm

Are there any countries where a CPAP and associated supplies are presently offered as OTC?

Australia - home of CPAP. No prescription for either machine or accessories. Resmed are at times reluctant to supply an ASV without medical involvement, which is probably fair enough.

While I can understand the thinking behind making the machine prescription only (even if I don't agree with it) what's the justification for masks etc?

80% of sleep apnea patients are undiagnosed.

Of those, a bunch suspect, or know they have an issue but refuse to seek diagnosis and treatment (it's a "guy" (mostly) thing).

34% of CPAP patients are non-adherent.

OTC CPAP doesn't fix the problem.

AAMOF it doesn't fix anything.

OTOH, $50 APAPs at Walmart? Couple that with an aggressive ad campaign (think "My Pillow")?

IMO Behar failed to note some of the other issues in the system:

3 month waiting period to see the sleep guy.

2 month waiting period to get an HST (REALLY? AN HST???).

1 month waiting period for the MD to "read" the HST (REALLY? PUSH THE BUTTON LABELLED "ANALYZE" AND WAIT 8 SECONDS!!!)

New system: "Honey, grab me an APAP at Costco while you're out, will ya? And a cube while you're at it."

I think Nocibur gets it.

As other posters have pointed out, insurance still covers prescriptionless items that have deemed a medical necessity.

No medication or durable medical product has ever become worse or less affordable by having its prescription status removed, including hearing aids. Removing prescription requirements leads to more people being treated in addition to better treatment options getting developed.

The system is broken.

Communities like this are providing more support for people with apnea, and making better diagnostic decisions than the medical-industrial complex is. Since doctors aren't necessary or for treating apnea, and they're failing to diagnose it, having a shelf of CPAP machines next to the hearing aids at Costco will be an improvement.

It's hard to imagine why people here are against changing something that would improve apnea treatment.

It seems like Stockholm Syndrome!

gotaug2 wrote: ↑

Sun Mar 16, 2025 10:26 pm

I think Nocibur gets it.

As other posters have pointed out, insurance still covers prescriptionless items that have deemed a medical necessity.

No medication or durable medical product has ever become worse or less affordable by having its prescription status removed, including hearing aids. Removing prescription requirements leads to more people being treated in addition to better treatment options getting developed.

The system is broken.

Communities like this are providing more support for people with apnea, and making better diagnostic decisions than the medical-industrial complex is. Since doctors aren't necessary or for treating apnea, and they're failing to diagnose it, having a shelf of CPAP machines next to the hearing aids at Costco will be an improvement.

It's hard to imagine why people here are against changing something that would improve apnea treatment.

It seems like Stockholm Syndrome!

If machines can be purchased OTC who is going to determine the settings for these machines and how will these parameters be entered into the machine? By the users themselves? Yeah, right. Who will diagnose these patients?

Communities like this are providing more support for people with apnea, and making better diagnostic decisions than the medical-industrial complex is.

Us folks here are making better diagnostic decisions than the medical-industrial complex? Really? I don't know about your sleep doc, but I'll take my doc's diagnostic decisions over advice I get from the internet every time.

I'm not saying that one can't get first class advice from this site, it's here for sure but one has to sort through what's what using one's common sense. I know that this is a VERY tall order for some people, and they need guidance, perhaps from a professional?

Well, The vast majority of routine uncomplicated apneas found in a patient in an in lab study. (Like me) Were sent home with a pap machine that was set at the factory 4cm-20cm setting. And just let the machine adjust on it's own. That is a rubbish way to treat a patient. So, what's the difference of going home from the Dr. or from costco with a machine set to 4cm-20cm. NONE at all.

It was this and the other apnea site that sent me towards better sleep. My VA sleep Dr saw the settings and sleep reports on my machine that I got from these two pages and said: Good job!