CPAPtalk.com

Guest wrote:Again, Den, yet again, call the FDA and ask them whether Rx is required. How clearly do I have to keep typing this???

Log in and show your name, chickenshit.

I feel pretty certain that the same rules are a-coming at cpapauction.com. Johnny (Goodman, owner of both sites) is clearly responding to some regulatory agency, and he can't afford to flaunt the regulations at either site.

Guest wrote:Again, Den, yet again, call the FDA and ask them whether Rx is required. How clearly do I have to keep typing this???

Is that the same FDA that allowed Medtronics to sell defective Defib leads and implant them into me, with no safe way to correct the problem. No thanks, I am tired of your god the FDA helping my health. Jim

JeffH wrote:

Guest wrote:Again, Den, yet again, call the FDA and ask them whether Rx is required. How clearly do I have to keep typing this???

Log in and show your name, chickenshit.

If he knew how to spell his name he wouldn't have to log in as a guest. Jim

I think this is a Medicare issue, causing this recent change, which filters down into everything, even those of us not on Medicare.

I recently bought a nice cpap off Craigslist, and when I questioned the seller, he cagely informed me that he works 'in the industry,' though not with a DME. He said the machine was an obsolete demo model. I mentioned my beef with my initial DME. He said he'd heard alot of bad things about them. I said that I thought any monkey with a banana could get a license to be a DME.

He said some recent changes in Medicare will start shutting down those types of DME's. I should expect to see many DME's closing down soon.

I didn't ask any more questions, happy to have the machine. Then two days later this thread from Johnny.

I don't know what's changed, but I know it wasn't Johnny's idea. I can only hope it WILL end up shutting down some of the more egregious DME's out there.

Side note - same day this thread came out, I got a note from my insurance telling me my sleep doc is no longer "with them" and I'd better go find a new sleep doc.

Yes folks, something's afoot out there.

Cheers,
Barbara

WearyOne wrote:Another stupid government intervention no doubt. Before long the government will be trying to tell us all when and how we should use the bathroom or get up in the morning!

Anywho, do you think this applies to cpapauction as well? I just looked over there and didn't see where masks require a prescription yet. Wonder if this also applies to mask parts (oral cushion, nasal pillows, etc.), when not purchased as part of the entire mask set?

Pam

I'll bet it does. What happens is you try to bid, and you get thrown into an endless loop with no explanation.

I finally complained when this happened to me in trying to purchase a cpap machine, and got a reply that I had a script for an AUTO, so they wouldn't let me buy a straight cpap.

So, it's got to be some sort of automatic computer thing that will not allow you to bid if you don't have the appropriate script on file.

Cheers,
B.

Lots of confusion on this.
The requirements, according to the labels on both a PAP and mask, require an ORDER.
This has been construed as a presription.
Pharmacies are licensed to fill a pRESCRIPTIOIN, not a DME.
They fill ORDERS.

One day I hope someone will find and post the statute that requires a RX.
I cannot find it, even at the FDA.

I should offer a cash reward for anyone providing this statute.

Please do not send the one that requires one for an intermittent breathing assisted device.
This is for an anesthetic device not a PAP.
a PAP provided continuous, not intermittent air.
Maybe I should start with a $20.00 prize for this.

SHOW ME THE LAW!!!

JeffH wrote:

Guest wrote:Again, Den, yet again, call the FDA and ask them whether Rx is required. How clearly do I have to keep typing this???

Log in and show your name, chickenshit.

JeffH wrote:

Guest wrote:Again, Den, yet again, call the FDA and ask them whether Rx is required. How clearly do I have to keep typing this???

Log in and show your name, chickenshit.

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

tomjax wrote:Lots of confusion on this.
The requirements, according to the labels on both a PAP and mask, require an ORDER.
This has been construed as a presription.
Pharmacies are licensed to fill a pRESCRIPTIOIN, not a DME.
They fill ORDERS.

One day I hope someone will find and post the statute that requires a RX.
I cannot find it, even at the FDA.

I should offer a cash reward for anyone providing this statute.

Please do not send the one that requires one for an intermittent breathing assisted device.
This is for an anesthetic device not a PAP.
a PAP provided continuous, not intermittent air.
Maybe I should start with a $20.00 prize for this.

SHOW ME THE LAW!!!

From the other current thread where you also asked that the relevant FDA law (Part 21 CFR 801 Subpart D) be cited:

-SWS wrote:

tomjax wrote: and I am still waiting for the statute that says a PAP requires a RX.

Tomjax, we've been hearing your adamant legal position about CPAP prescription status for years now. However, the central question here is what the FDA legally maintains regarding CPAP prescription status.

Bear in mind I'm neither pharmacist, lawyer, nor government bureaucrat. But I just went to the FDA website and randomly pulled
an FDA approval letter for the first CPAP machine that my mouse happened to click on at random:
http://www.accessdata.fda.gov/cdrh_docs ... 053486.pdf

Page 5 of that FDA approval letter clearly designates "Prescription Use _X_ (Part 21 CFR 801 Subpart D)".

Bear in mind that's not a third-party legal opinion. Rather, that's a letter written by the FDA in 2006 stating exactly which federal law THEY think mandates prescription status for that CPAP machine. If the FDA agreed with you, Tomjax, they would have put a big "X" by the "Part 21 CFR 807 Subpart C" section of that same page.

tomjax wrote:Yet the confusion continues

Apparently not on the part of all those DME's who are legally required to demand a CPAP prescription--- because of the FDA's "Prescription Use (Part 21 CFR 801 Subpart D)" legal requirement. End of confusion I hope.

2flamingos wrote:This may be a stupid question, but what constitues the rx? All I have is a copy of the titration results with the doc's statement of the doc's "recommendations" ( Auto CPAP with the settings, A-flex w/ heated humidifier - then this signature and that of the director of the sleep lab). Would that suffice? Or does it have to be on a piece of paper from an rx pad?

A piece of paper from an RX pad! Believe it or not. A full report with a letter of prescription where you have all the details from the pulmologist is not enough (titration, type of machine recommended etc...). My referring doctor who is a specialist in internal medicine fully transfered me to a pulmologist (he admitted his ignorance in the matter) for a complete takeover. The pulmologist recommendations is not enough!!!! They need a piece of paper from an RX pad! I WON,T PLAY THAT GAME. I am going to buy elsewhere.

In Canada you don't even need a prescription neither a report. You need nothing. Who will be buying a piece of equipment which costs near 2,000$ just for fun!!!! That prescription fuss is a complete sutpidity that has nothing to do with patient safety but essentially with the business of health care, with MONEY. Period.

CPAP.com should move their business in Canada or anywhere in the world where those stupidities are not the rule.

2flamingos wrote:This may be a stupid question, but what constitues the rx?

I live in the USA, and did not need the Rx pad note. I was given a typed page which listed the titration results, the type machine recommended with humidifier, and a mask "of the patient's preference," as well as the pressure setting range. The page was signed by the MD.

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 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.

I suppose we're supposed to trust the words of an anonymous person?