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FDA petition to grant OTC status to CPAP machines - gotaug - 03-13-2025
I just stumbled across a Citizen Petition to make CPAP equipment OTC!
Hearing aids have been deregulated, and so should CPAP machines.
Hopefully, I can post the links below.
This is the Citizen Petition:
http://www.regulations.gov/document/FDA-2024-P-2242-0001
Here is a link to the letter making the request:
https://downloads.regulations.gov/FDA-2024-P-2242-0001/attachment_2.pdf
I added a comment in support of this, here:
https://www.regulations.gov/commenton/FDA-2024-P-2242-0001
I'm sure more comments will help!
RE: FDA petition to grant OTC status to CPAP machines - gotaug - 03-13-2025
The comment I submitted to the FDA included the following pdf files:
Can Continuous Positive Airway Pressure Be Self-Titrated.pdf
and
A Continuous Positive Airway Pressure Trial as a Novel Approach to the Diagnosis of the Obstructive Sleep Apnea Syndrome.pdf
I referred to those studies and said:
Quote:Almost twenty years ago, it was noted that "The risks and costs of prescribing CPAP to occasional patients experiencing a placebo effect during a CPAP trial has to be weighted against the consequences of untreated OSA in a large number of patients awaiting polysomnography."There is no reason to be as thorough as I was. I wanted to use the comment I submitted as a way to explain why the issue is so important to me, personally.
The answer is obvious. The above-mentioned placebo effect would still lead to an improved feeling of well-being on the part of the patient -- and CPAP won't harm a person who doesn't have apnea -- so there is no danger in someone buying CPAP equipment, which is the typical reason for requiring a prescription.
The above quote is from the January, 2006, issue of Chest Journal published the study: "A Continuous Positive Airway Pressure Trial as a Novel Approach to the Diagnosis of the Obstructive Sleep Apnea Syndrome". It goes on to state:
"Untreated OSA represents a risk for affected individuals and the community by the associated traffic accidents, high BP, and other cardiovascular complications. Furthermore, delaying the diagnosis deprives patients from improvement in sleepiness, quality of life, and optimal professional performance. These points strongly emphasize the need for development of strategies that facilitate and expedite the diagnosis and effective therapy in OSA patients in the face of the limited capacity for performing polysomnography. By providing diagnostic information and treatment at the same time, the proposed novel approach to the evaluation of suspected OSA fulfills this requirement." https://doi.org/10.1378/chest.129.1.67
And more than 20 years ago, a study in the American Journal of Respiratory and Critical Care Medicine posed the question "Can Continuous Positive Airway Pressure Be Self-Titrated?" and concluded:
"In summary, this study demonstrates that self-titration of CPAP in patients with OSA is as efficacious as manual titration in a sleep laboratory, with similar subjective and objective outcomes, and CPAP compliance." https://pubmed.ncbi.nlm.nih.gov/12598214/
Other studies have had similar findings, since then. Plus, the quantity and quality of resources available to CPAP users, via online support communities, forums, tutorials, and videos, has greatly improved and continues to improve.
Modern CPAP equipment is much more user-friendly and capable now, and for years people have been using CPAP without any medical supervision, often with equipment which they purchased used, without a prescription.
OTC CPAP sales won't eliminate the need for apnea focused sleep medicine the same way approving OTC availability of mandibular advancement devices, reading glasses, and hearing aids, hasn't reduced access to their related medically specialty services.
Insurance is still available for the previous examples of medical equipment, even though it is sold OTC. There is no reason to think that CPAP equipment and sleep medicine in general would be any different.
Deregulating CPAP equipment would increase competition and innovation in the field, reducing prices and improving therapy effectiveness.
CPAP equipment is less dangerous to use than Tylenol, yet a lack of CPAP treatment has been proven, time-and-time-again, to have serious and even fatal consequences.
It is time to remove the barrier that CPAP prescriptions create, so that people can begin sleep apnea treatment in a timely and cost-effective manner.
It isn't terribly complex, so if you don't want to delve into this or that rationale, you can simply say you think that making CPAP equipment available OTC is a good idea.
Even a brief comment will help!
RE: FDA petition to grant OTC status to CPAP machines - greatunclebill - 03-13-2025
when things become otc and/or not medically necessary insurance tends to not pay for them.
RE: FDA petition to grant OTC status to CPAP machines - gotaug - 03-14-2025
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?
RE: FDA petition to grant OTC status to CPAP machines - tpone - 03-14-2025
There are cost differences however. Ongoing research into sleep related issues, developing new algorithms , extensive testing etc does add to the cost of the new firmware, even though the hardware cost is the same. Having said that I don't think the pricing policies are just based on costs alone. Most public companies will charge as much as they think the market will bear, regardless of costs.
RE: FDA petition to grant OTC status to CPAP machines - gotaug - 03-14-2025
Resmed hasn't spent a lot for ongoing research/testing/etc, if their most recent offerings are using 11-year-old algorithms, and eight-year-old blower designs.
Maybe if they faced some competition, they would up their game.
They certainly couldn't be any more lackadaisical about advancing CPAP technology than they currently are.
RE: FDA petition to grant OTC status to CPAP machines - srlevine1 - 03-14-2025
An OTC version of ResMed’s xPAP devices would necessitate a change in their business model to shift the marketing focus from prescribers to include consumers. This would result in additional advertising and customer service costs. Competition might extend to marketing a design esthetic and additional gamification. Additional pricing pressures might result in a race to the bottom where margins demand cost-cutting and less durable devices.
As for algorithms and sensor improvements, unless basic research yields a breakthrough and new understandings, this might be a non-issue.
Be careful what you wish for as unintended consequences and karma might be just around the corner.
RE: FDA petition to grant OTC status to CPAP machines - SarcasticDave94 - 03-14-2025
The argument that everyone needs ASV is false. The ASV is used to treat Central Apnea. While lots may show a few Centrals in OSCAR, they are more likely to not require ASV treatment.
I'm not at all for Big Gov and control, however without FDA being involved, think how many in the US would still be using their Philips Respironics foam gate machines.
I don't see how changing CPAP equipment to over the counter helps the patient.
As for wheelchairs, to get my power wheelchair, I had to get my primary care physician involved. He had to refer me to physical therapy for an evaluation. That PT office helped get me in contact with the builder for the power wheelchair. And it did need to be ordered by a physician, if I wanted insurance to pay.
RE: FDA petition to grant OTC status to CPAP machines - greatunclebill - 03-14-2025
medical necessity plays into medical equipment. cpap is obvious. daves chair is obvious. my hearing aids are obvious. the hearing aids that are otc are a new class of mainly amplifier hearing aid for some patients that think they need them and certain conditions. they are not the same as full blown hearing aids that require a prescription for patients in the medical necessity category.
RE: FDA petition to grant OTC status to CPAP machines - tpone - 03-14-2025
(03-14-2025, 08:08 AM)SarcasticDave94 Wrote: I don't see how changing CPAP equipment to over the counter helps the patient.
In my case I have just come off 6 weeks supervised Cpap trials which was quite unsuccessful - the most I managed was about 2 hours in a night and about 50 minutes straight. The main issues were that the sleep centre provided different masks - all reasonably old and none that I felt were big enough to fit properly. I went back a couple of times but they had nothing to suit. They also supplied a Lowenstein machine which lacked flexibility for my needs and caused problems.
I am still seeing the sleep specialist doctor but purchased a Resmed Aircurve 10 Vauto and initially set it to the same settings as the sleep centre had set. There were big differences the second I put it on in that I did not sustain aerophagia like I did with the Lowenstein, which also used to go to exhale mode occasionally and without warning while I was inhaling. This was very disconcerting and would always wake me. ( no adjustment possible according to the sleep tech) apart from switching off EPR.)
I also shopped separately for masks and had one place do a proper fitting and hired the correctly sized masks to try before I buy. These 2 changes have made the biggest difference to me and I have slept far better than before and exceeded 4 hours on my first night. I previously dreaded going to the "torture chamber" at bedtime but now look forward to it.
The point being I don't know how I could have got here so quickly if I was limited to a prescriber only system.
However, on the issue of cpap machines, the USA is way ahead of the rest of the world in terms of insurance support. It might have been due to good lobbying by Resmed but there aren't too many places I can think of where private health insurance will pay for the entire cost of the cpap machine and in some cases the associated paraphernalia as well. Since health insurance companies in the USA have agreed to cover the full costs of machines etc, it seems prudent that they would also want prescriptions to prove the cost is a necessity. I know the FDA sets the rules but they would have done so after extensive consultation with all parties including insurance companies.