Why it IS illegal - sort of - to change your pressure.

Wonder what would happen if I went to the local FBI office and said, "I'm here to turn myself in. I changed the pressure on my CPAP and I want to make a plea-bargain."

well at the LEAST you'd get a really funny look AND you would get maybe a question, "WHAT is a CPAP?" haha and hopefully whatever you would do you wouldn't also have your machine with you to show them the proof! they might think it's some sophisticated bomb type device!

AND if you had your mask on -- well then you'd probably spend some time for observation!!!

M.D.Hosehead wrote:Wonder what would happen if I went to the local FBI office and said, "I'm here to turn myself in. I changed the pressure on my CPAP and I want to make a plea-bargain."

I don't think you're competent to stand trial.

chunkyfrog wrote:The one main thing I have gotten out of this discussion is that there is a distinct possibility that
'unauthorized' self-titration could POSSIBLY result in insurance coverage problems.
Insurance companies--bleah.

It's been a long time but I remember that I had already learned here how to change the settings from the Dr's original RX of 5-18cms(disaster) to 11-15cms. When we had our second and last followup he gave me a thumbs up and was surprised when he read the data printouts I brought him. But I watched as he made a note in the chart that "spouse may make pressure setting adjustments as necessary as per my instructions given". Not exactly verbatim but he said he wanted it documented for "insurance purposes".

Dori -- that is so cool that he did that -- nice doc.

DoriC, that's exactly the approach we should work toward with our medical teams. My doctor found I could make pressure changes. My DME had set one of the pressures too low. I had been bumping it up and explained how I was doing it. (Adjust upward, monitor apneas, repeat). He then essentially then stated "Good! You understand the titration process. Start at ____ settings, then monitor from there. Then in the future just review your changes and why you made them with me."

I've not had to adjust my pressure, but I continue to keep an eye on my therapy - by checking the data collected by my unit.

Xj220c argues that §301(b) of the Food, Drug, and Cosmetics Act (FDCA), 21 USC §331(b), makes it is illegal in the United States for a consumer to change his xPAP pressure. For anyone who is interested, the FDCA can be found several places on the internet, including the FDA website, http://www.fda.gov/RegulatoryInformatio ... ActFDCAct/. To provide a little more context, I will quote a couple of additional subsections (there are more after that):

The following acts and the causing thereof are hereby prohibited:

(a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded.

(b) The adulteration or misbranding of any food, drug, device, or cosmetic in interstate commerce.

(c) The receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.

(d) The introduction or delivery for introduction into interstate commerce of any article in violation of section 404, 505 or 564.

Xj220c correctly notes that a consumer changing a pressure setting would have to be both an "adulteration" and "in interstate commerce" to violate the law.

Take interstate commerce first. The act as a whole is clearly aimed at manufacturers and sellers, not consumers. Look at those subsections above. They revolve around references to delivery, payment, and commerce. The rest of the act is the same way. Historically, the FDCA was a consumer protection measure growing out concerns about contaminated food and drugs, not misuse by individuals.

Imagine that the act applied to the consumer. Remember, it applies to food as well as drugs and medical devices. If someone were to smoke a cigar after dinner and allow the ash to fall into what was left of his ice cream, he would have adulterated food. Why, if I were to make a chicken salad sandwich (sorry Rooster), you might say I had adulterated my chicken with mayonnaise and pickle. It wouldn't be in interstate commerce though, and no sensible person would argue otherwise.

Xj220c doesn't fight this issue very hard for an owned machine, but proposes that a rented machine is in interstate commerce. I don't think so. Any reuse of the machine would come after a reset, refurbishing, new prescription, and new setting. Whatever you might say about the blower itself, the so-called adulteration would never make it into interstate commerce.

The real weakness of xj220c's argument, though, is his contention that a change in a pressure setting is an adulteration. He seems to be saying that any change in state is an adulteration, but that is not so.

First, standard definitions of adulteration equate it with contamination, not mere alteration. The web version of Merriam-Webster defines adulterate as

to corrupt, debase, or make impure by the addition of a foreign or inferior substance or element; especially: to prepare for sale by replacing more valuable with less valuable or inert ingredients.

Tweeking a dial – or the software equivalent – just doesn't meet that definition. It's not like ruining good chicken with mayonnaise.

Second, the FDCA doesn't rely on a dictionary definition. Section 501, 21 USC §351, states when a drug or device shall be deemed to be adulterated. It is too long to quote here, but anyone can read the section at the FDA web site cited above. It starts out terms that echo the theme of contamination:

(a) (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health ...

Much of the section has to do with concepts that only apply to drugs, like purity. But to the extent it refers to devices, it defines adulteration in terms of failure to conform to performance standards and regulations established pursuant to other sections of the act. See subsections (e) and (h), for example. There is nothing remotely suggesting that changing a setting could be deemed an adulteration. I certainly don't buy xj220c's analogy between changing a setting and installing new firmware. New firmware would require the manufacture to file a new §510(k) report, completely different from changing a setting that is designed to be changed.

Third, xj220c's argument is a classic example of an argument that proves too much. If it would be a violation of §301 for me to change my pressure, why wouldn't it be just as much a violation for my doctor or respiratory technician to change it? The section doesn't say "except doctors or RTs." But that makes no sense, you protest. True, but most of us don't think it makes sense to tell consumers that they cannot change their pressure either. If you take one section of a large piece of legislation out of context and try to apply it to a situation it isn't intended for, you get wacky results. This act is about forcing manufacturers and sellers to meet standards of safety. Section 301(b) isn't meant for doctors or patients, but if you interpret it the way xj220c proposes, it applies equally to both, and no one can change the pressure. Likewise, if tweeking the pressure is adulteration, why not tweeking the ramp time, or the minimum start-up pressure, or a dozen other parameters? It is far more logical to conclude that changing a pressure setting is not adulteration within the meaning of the FDCA.

Xj220c had two more arguments, but they did not refer to any specific law so I'm going to give them short shrift, especially since I've been long-winded already. Insurance fraud? He relies on a recollection that medications and devices are only covered if used "as prescribed" by a physician. I don't remember any such "as" in my benefit booklet, but it's at the office. I am supposed to take Lipitor every day. I would hate to think that on those mornings when I neglect to do so, and there have been more than a few, I commit insurance fraud. I trust that if I ever have a heart attack, Blue Cross won't say, "Sorry PST, no stent for you. And by the way, you owe us for the last five years of Lipitor." That is what xj220c is saying, and I've never heard of such a thing. Using a device without a prescription? He just speculates on what the law might be in some state. Find a law and we can see how it has been interpreted. I will just propose one more hypothetical. Many people with low incomes and no insurance try to stretch their medications by taking less than prescribed. If I break that Lipitor pill in half every morning to eek two months out of each bottle, am I breaking a law? If so, name it; any state will do.

In summary, I remain unconvinced that anyone has yet found the legendary law that makes it illegal for a patient to change the pressure setting on his xPAP machine. It is something that I don't do, by the way. I agree with LinkC and several others on this one. I talk to my doctor first. But maybe I just lucked out with a good doctor and an easy adjustment, so I don't want to pass judgment on others. If I did decide to change my pressure, though, I would not worry for one second that I was breaking the law.

xj220c wrote:

Physician wrote:Your catalytic converter analogy is defective. The automobile is licensed/registered and under State control. In your automobile exhaust modification analogy one is polluting the air which others must breath.

That example was really directed to rebut the concept that once you own something you can do with it as you please. What I was referring to in that example was the federal rule that prohibits removal of the catalytic converter under any circumstance other than to repair or replace it. It was just an example that you can't just do as you please just because you handed over money for something.

In the context you're referring to I think the better analogy is the one I gave about air bags and seat belts. Removing the seat belt doesn't really affect anybody except the driver, but it's still illegal to drive without that seat belt on.

Hope that clears it up.

.

Doesn't effect anybody but the driver ? NOT TRUE. Your seatbelt analogy is not valid. In the absence of a seatbelt, one can be dealing with death, a projecting body on the highway, other avoidance collisions, etc. No comparison.

And again, the prescription is for the CPAP unit and/or sleep study. The settings are best termed "recommendations". I deal with many medical-legal issues and have never heard of a third party carrier denying benefits under any of the circumstances you are postulating. Health insurers often pay for iatrogenic (physician-caused) and patient-caused illnesses and injuries. In the extreme, a suicide attempt/gesture is an example of a patient-caused event which is still covered by insurance.

So exactly what do you think will happen to a patient who adjusts his/her own pressure, what would be the pathology, and why would the carrier deny benefits ?

Please give us something other than "theoretical" or hearsay.

Physician wrote:
Please give us something other than "theoretical" or hearsay.

You want a lawyer to give you something that is not theoretical or hearsay? Ask my ex-wife's lawyer, he will show you all of my money. Is that real enough for you?

Physician wrote: Please give us something other than "theoretical" or hearsay.

Kinda makes you wonder why a lawyer would take all this time to post this stuff on a CPAP site. Well, everyone is down on me for attacking "professionals". Is this person a professional - or is he one of the "hit and run" posters we have been seeing lately? The most obvious one is Calist, but I suspect that Calist has friends and cohorts all helping him along. We don't even know if Calist is a sleep professional. We just know he is crazy.

Even if this guy isn't related to all of that - how do we know his statements are close to reality? A lawyer posting on the legality of changing your CPAP pressure? Sorry, I could not imagine that unless we get billed at $350 per hour! I say I want a scan of his law degree and I'll let it be. If someone came on here and said they were the Pope would we believe them? Well, if I challenged them, I probably would get grief by someone for that too.

The fact is that we don't know who is a professional or not - and at what? If a professional want to come on here and present their credentials (something real, not just a claim that they exist), I will gladly listen and shut up. Anyone?

jonquiljo wrote: If someone came on here and said they were the Pope would we believe them? Well, if I challenged them, I probably would get grief by someone for that too.

...

Amy Harper and The pope - Calist and Calist! The professional. You make my point for me. You come on and pretend to be whomever you please. That is not professional.

It is a sin to delete the posts of others my son.

It is a sin to delete the posts of others my son.

It is a sin to delete the posts of others my son.