Changes To CPAP.com Prescription Policy

Guest wrote:Babette: If you bought a CPAP off craigslist as someone's "demo" from them being in the business, then you can rest assured that you've received stolen property. Eventually the S/N of your machine will reveal itself and hopefully the dope that sold it on craigslist will be fired from his employer.

guest you are funny

I'm picturing the cpap police coming and banging on babettes door to interrogate her.

When I think about all the noxious chemicals I used to use in my business without needing any kind of license but I need a script for a plastic mask....wow.

ETA: Dear guest. The government, police, etc, can't manage to deal with the black market of the various gangs, mafias, etc let alone the drug trade and they are going to go after the poor guy who sold his cpap machine on craigslist!! LMAO

More approval documents from the FDA regarding humidifiers and CPAP masks as prescription items:
http://www.accessdata.fda.gov/cdrh_docs ... 040941.pdf
http://www.accessdata.fda.gov/cdrh_docs ... 042455.pdf

Apparently the FDA approves humidifiers and CPAP masks citing that same FDA Code of Regulation Part 21 CFR 801 Subpart D that they use for CPAP machines. Again, if the FDA decided to clear either of these devices as OTC, then they would have checked Part 21 CFR 807 Subpart C on the approval letters instead.

That FDA Code of Regulation Part 21 CFR 801 Subpart D can be found here:
http://www.accessdata.fda.gov/scripts/c ... FRPart=801

tomjax wrote: Maybe I should start with a $20.00 prize for this.

Not to worry... I gladly accept PayPal for peace of mind. It's safe and secure. Seriously, whether you disagree with the wording or principle at hand, it's clearly FDA Code of Regulation Part 21 CFR 801 Subpart D that the FDA legally maintains as their regulatory category for CPAP equipment as prescription devices rather than OTC.

The bottom line is I faxed my latest xPAP prescription (written by the doctor today) into CPAP.COM. I'm pretty sure all this politically-leveraged legal-weenie regulation doesn't make a CPAP mask or humidifier any more or less dangerous to me or anyone living in my household. Absolute political nonsense IMHO.

Snorebert wrote: And we keep wondering why Americans pay the most of mediocre healthcare outcomes. The delivery system sucks up a lot of cash.

Amen. The outrageous system at hand: clearly broken by red tape and corporate leveraging tactics.

SWS, I am still not convinced.
Color moi stubborn.
Many companies will refer to the RX requirement and DME will also.
Maybe some recent statutes have clarified this but I am not aware of any.
I once called the FDA and the person I spoke to assured me a RX was required, but after I told him to quote me verse and chapter, he could not.
Just that he was regurgutating wat he dad been TOLD.

Another confusing thing that many refer here is to getting a copy and having it filled or faxing a RX and getting it filled.
I am not currently a pharmacist, but was for 35+ years.

I can assure you that a COPY is for informational use only according to pharmacy law and may not be used to fill a rx.
To be legal, a pharmacist must make a TRANSFER which cancels the original and makes the COPY legal.
Also, a fax is the same.

Imagine a person getting a copy and taking it to several pharmacies to be filled.

Same for a fax.
Could you get on your fax machine and fax the RX to every store in town and then go by and pick ut the meds?
Of course, many times common sense is uased and there no problems arise.
But here the pharamcist uses judgment abd assures him/herself that nothing funny is going on.

Another quirky thing is that a controlled substance may be tranferred to another pharmacy and fill if the original is cancelled by the issuing pharmacy.
But it ends there. I may not be transferred again.
I have had this scenario happen in my practice and the abusive patient was very unhappy.
Sorry.

Tomjax, the FDA clearly regulates CPAP machines not as: 1) OTC devices, and not as 2) prescription devices requiring ordinary directions for use, but as 3) prescription devices that are exempt from adequate directions for use. The FDA very explicitly categorizes cleared CPAP machine models as prescription devices versus either OTC or both categories.

So you asked to see the FDA law, and I pointed out that all the FDA clearance documents prohibit OTC status for CPAP equipment while very explicitly regulating CPAP equipment using FDA Code of Regulation Part 21 CFR 801 Subpart D. You asked for the law and there it is!

However, aside from the FDA very clearly regulating CPAP devices as prescription devices (and not clearing as OTC), you cite the interesting fact that CPAP prescriptions are not handled by DME providers according to the laws and regulations that pharmacies are bound. Interesting and true. However, I'm not convinced that those arguably insufficient prescription-handling practices by DME providers is legal basis to allow any DME provider to treat CPAP machines as OTC when the FDA clearly regulates CPAP as prescription.

Your underlying argument is that common failure to adhere to but some prescription-handling procedures in the overall process, sufficiently negates the FDA's overarching rulings and regulations that CPAP machines are explicitly prescription devices rather than OTC. I can't say that I agree with you that a common failure to dot the "i's" and cross the "t's" way back at the point-of-sale part of the process somehow negates the overarching FDA regulation explicitly stating that these devices are prescription versus OTC.

If I were a DME provider, I might be very comfortable adhering to common prescription-handling practices. But I would be very legally uncomfortable deviating from those common DME prescription practices to be one of the very few selling these devices as if they were OTC when the FDA expressly categorizes them as prescription devices.

I still accept PayPal.

6PtStar wrote:I have a question about scripts. I have one on file at cpapauction. Since it is owned be cpap.com is that script good at cpap.com also or do i have to send a seperate copy to cpap.com. Did not think it was a problem because I only bought mask and parts, hoses filters humidifier chamber., etc. With the new policy all of a sudden things have changed. Anyone ever asked this before?

Jerry

I turned in my RX to cpap.com, and it works on cpapauction.com. They are the same entity, as far as I can see. I wouldn't worry.

Cheers,
B.

So Babette- I uploaded my prescription to cpapauction.com when I bought a backup machine.

Are you saying that my prescription is also now with cpap.com as well?

Does it work both ways? I'm just trying to be sure I have this right!

Hawthorne wrote:So Babette- I uploaded my prescription to cpapauction.com when I bought a backup machine.

Are you saying that my prescription is also now with cpap.com as well?

Does it work both ways? I'm just trying to be sure I have this right!

I just created a login account with CPAP.COM yesterday. I discovered that after logging in, I could view scanned copies of all my prescriptions that CPAP.COM has on file. You can also view all your past CPAP.COM transactions once logged in.

A very efficient business IMHO.

-SWS wrote:The outrageous system at hand: clearly broken by red tape and corporate leveraging tactics.

That says it. Exactly.

Should we be getting up a letter-writing campaign for making the machines OTC?

Or does this mean the kid down on the corner will soon be offering to get me my next ResMed in exchange for a handful of OxyContin?

Hawthorne wrote:So Babette- I uploaded my prescription to cpapauction.com when I bought a backup machine.

Are you saying that my prescription is also now with cpap.com as well?

Does it work both ways? I'm just trying to be sure I have this right!

I had a Rx at cpapauction.com.
I just got a new machine from cpap.com.
They got a copy of my Rx in seconds from cpapauction.com

They're good!

Hawthorne wrote:So Babette- I uploaded my prescription to cpapauction.com when I bought a backup machine.

Are you saying that my prescription is also now with cpap.com as well?

Does it work both ways? I'm just trying to be sure I have this right!

If I were you, I'd check with CPAP.COM. My prescription had been on file at CPAP.COM for four years, but when I signed up with CPAPAUCTION.COM, they (CPAP.COM) transferred a copy of it to the auction site. I don't think it works the other way around (or either way for that matter) without making a phone call or request by e-mail.

Den

Thanks carbonman!

jnk wrote:

-SWS wrote:The outrageous system at hand: clearly broken by red tape and corporate leveraging tactics.

That says it. Exactly.

Should we be getting up a letter-writing campaign for making the machines OTC?

Or does this mean the kid down on the corner will soon be offering to get me my next ResMed in exchange for a handful of OxyContin?

I personally think that CPAP machines should be prescription devices because there are some serious contraindications. But again, I will point out that some industrialized nations regulate CPAP as OTC. So there's definitely room for argumentation on both sides of that coin IMHO.

But bogging down humidifier, mask, and CPAP accessory purchases with cash-sucking and barrier-imposing red tape is explicitly what I object to. By the time patients are subjected to jumping through those hoops, complements of revenue-draining bureaucracy and corporate market leveraging, the patients clearly lose IMO. If the CPAP machines are regulated by prescriptions, then the accessories should all be implicitly grandfathered and easy to replenish IMHO.

So who's going to die from either toxicity or blunt trauma imposed by CPAP masks and humidifiers? Absolutely nobody I would posit. And who's going to suffer tragic non-compliance because ongoing CPAP supplies are administratively unattainable for some? I think bureaucracy and regulation are absolutely necessary. But I also think unnecessary bureaucracy and regulation can be potentially fatal in some health-related cases, this being one. And the mere thought of death by unnecessary bureaucracy makes my blood boil.

Regulating masks and humidifiers by prescription is absurd if not tragic. But my fear is that it's probably tragic for some unknown margin of humanity.

Wulfman wrote:

Hawthorne wrote:So Babette- I uploaded my prescription to cpapauction.com when I bought a backup machine.

Are you saying that my prescription is also now with cpap.com as well?

Does it work both ways? I'm just trying to be sure I have this right!

If I were you, I'd check with CPAP.COM. My prescription had been on file at CPAP.COM for four years, but when I signed up with CPAPAUCTION.COM, they (CPAP.COM) transferred a copy of it to the auction site. I don't think it works the other way around (or either way for that matter) without making a phone call or request by e-mail.

Den

I just went to cpap.com and created an account abd it did not find any of my previous orders or my cpapauction script. I guess I am going to have to send it again. I hope I can still find it.

Jerry

A cpap mask and humidfier are useless without the machine so why a prescription for those??

-SWS wrote: I personally think that CPAP machines should be prescription devices because there are some serious contraindications.

Sure, but lets have the pharmacies be the distribution point rather than these DME's... many of whom are useless and don't give a crap about the patients health.