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

[nobody]

Don't be fooled. There are many ways to troll. This OP is yet another one of them. Bottom line is it's complete bull to suggest, or carry-on as though you're a lawyer, that it's illegal for a patient to change their own settings on their own machine. It's not illegal to take your own prescribed drugs in any way you see fit either. I hope people are not fooled by any of this nonsense. It is better to get the optimal therapy for you, whether you work with your doctor or on your own, rather than worrying about whether the police are going to come to your house because you changed your pressure on your CPAP machine. Please give us all a break already with this stupidity

[BlackSpinner]

Don't be fooled. There are many ways to troll. This OP is yet another one of them. Bottom line is it's complete bull to suggest, or carry-on as though you're a lawyer, that it's illegal for a patient to change their own settings on their own machine. It's not illegal to take your own prescribed drugs in any way you see fit either. I hope people are not fooled by any of this nonsense. It is better to get the optimal therapy for you, whether you work with your doctor or on your own, rather than worrying about whether the police are going to come to your house because you changed your pressure on your CPAP machine. Please give us all a break already with this stupidity

Did you even bother to read the posts?
The OP gave an overview of a series of federal laws and the some of the interpretations of them and some possible issues and some possible enforcements of them. Knowledge is power. Plus lack of knowledge is not a valid legal defense. Considering just how sue happy the US is I think you would want to know this information instead of burrying your head in the sand.

[nobody]

[ some of the interpretations of them

This is the problem with it, but hey if you want to believe this nonsense feel free. Just remember anybody can claim to be a lawyer online and offer up a bunch of legal sounding bullshit.

[BlackSpinner]

[ some of the interpretations of them

This is the problem with it, but hey if you want to believe this nonsense feel free. Just remember anybody can claim to be a lawyer online and offer up a bunch of legal sounding bullshit.

And you can prove this? You have the quotes of the laws? and the court rulings?

[Physician]

Think of this: Say you go out and buy a car, pay cash. That car is "yours". Does that mean that you can pull the catalytic converter out of it? Nope! It's illegal to remove that converter for any reason other than to repair or replace it. Even though the car is 100% yours doesn't give you the 100% right to "do whatever you want with it." The libertarian philosophy breaks down fast once there's a citation issued - and that's all I'm gonna say about dat.

Cheers,
XJ.

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.

But when adjusting one's own unlicensed CPAP which requires no mandated recertification, it deals only with that individual.

[GumbyCT]

I would certainly hope that no one starts any "fireworks" over such a well-researched, and well thought out point of view over whether or not it is "illegal" to change settings on one's medical device.

I have to agree that the OP's posts are well thought out and presented fairly in an effort for us to understand the law. This has never been done before regarding this topic - only to say, "I've been told it's illegal".

I don't agree that it is illegal for me to change my pressure but I do like the way XJ presented his points and respect the time, effort, and research that s/he went thru to accomplish this for us.

I think that adulteration would be more drastic than a pressure change but since I am not a lawyer will leave it at that.

XJ - I just wanted to say that I do value your contributions to this forum and hope you will ignore the negative comments to the contrary. I am sure others also value your contributions.

I look forward to discussion for the sake of learning.

Thank You for your time.

EDITED to add: I have never learned a thing from those who always agree with me - Gumby.

Edit 2: I wanted to refresh that great OP here -

OK, I know I'm going to regret posting this, but what the hooey. Let's go for the ride.

There's been a big debate in a couple of threads about whether it's legal or illegal for a patient to change their pressure settings without their doctor's (or their PA's or their RT's, etc.) having a say about it. IGNORING COMPLETELY WHETHER OR NOT THIS IS A GOOD IDEA, which you guys can debate into infinity, I decided to dust off the law degree and have an actual look at what the law is on this subject. Bear in mind that this info relates to the US only and will vary to a certain degree from state to state. Also bear in mind that I'm not offering any specific legal advice here. What's in this post are my own opinions on this subject and is not intended as specific legal advice that any individual should rely on. (Sorry, had to say that. Don't want to get kicked out of the bar for not doing so.)

So is it illegal to change your own pressure?

The answer is - maybe.

There's no clear law on this. There's no statute or regulation that I can find that specifically says you can't do it. There are, however, a couple that, when read the way lawyers read them, strongly suggest that changing the pressure on your machine would violate the law. Here are some examples:

1. Adulterating a Medical Device

Federal law, 21 USC § 331(b) to be precise, prohibits "(t)he adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce."

You'll note that this statute uses extremely broad language. As a general rule statutes are interpreted by the courts so as to give meaning to the purpose that Congress had in mind when the law was written. That means when you get broad language like this the courts are going to interpret it as meaning almost anything that could possibly be included under that language. In this case it's clear that CPAP machines are "devices" under the meaning of this statute. What's really important for our issue is whether changing the pressure is an "adulteration" of the machine and whether it's "in interstate commerce" once it's sitting on your nightstand.

I think the answer to both of these questions is "yes".

It's my opinion that changing the prescribed pressure on your machine is indeed an "adulteration" because you're altering the way the physician prescribed it for you. The fact that it can be easily adjusted is not the point. The legal reasoning is more complex than that. Think about the following example and I think you'll see why:

Suppose that CPAP machines could not be adjusted for pressure. Instead, the manufacturers just made a bunch of different models each of which put out a different individual pressure. If your Rx said 10cm then you got the model that put out 10cm and that would be that. In order to change the set pressure you'd have to pop open the machine and fiddle with the firmware embedded on the machine's microprocessor. Would doing that be "adulteration" of the machine? You bet it would! That kind of thing is clearly within the legal meaning of adulteration. In fact, the FDA has sent out circulars specifically telling hospitals that mucking around with the internal settings and firmware of a medical device constitutes adulteration. There's no question that changing the pressure under such circumstances would be adulteration.

Now apply that same logic to your actual CPAP machine. What are you doing when you access the hidden physician's menu and change your pressures? Well, you're doing exactly the same thing as in the example above. The only difference is that your actual CPAP machine happens to have a way to make those adjustments without having to pop open the device and monkey with the chips directly. This does not, however, change the fact that you're messing with what was supposed to be a fixed setting in the firmware of your machine. Your doctor prescribed and your DME delivered a device set up just like the fixed pressure devices in the example I gave. Changing the firmware settings on an adjustable CPAP machine - even though it's easy to do - is legally speaking the exact same thing as monkeying around with the chips on the fixed pressure machine in the example. Changing the pressure is adulteration.

But so what? The law says that you can't adulterate a device "in interstate commerce". Once somebody gets a machine it's no longer "in interstate commerce" now is it?

Well. maybe yes and maybe no.

What constitutes something that's "in interstate commerce" is a very complicated legal question. There are literally thousands of court decisions on this very point. Whether or not your machine is still in interstate commerce depends on your actual circumstances.

If, like me, you bought your machine outright, own it free and clear, and never sell it on Craiglist then your machine probably isn't in interstate commerce anymore. However, if you're renting a machine or if your insurance carrier requires you to exchange the machine for a new one or even if you swap it out with the manufacturer on a warranty exchange then your machine definitely, absolutely, positively is still "in interstate commerce". It's still moving through the commercial world. It still could be bought or sold by somebody else.

Change the pressure on such a machine and you'll have adulterated a regulated medical device that is in interstate commerce. In other words, you'll have broken federal law.

BUT!!!! All of that long-winded legal mumbo-jumbo aside. It really doesn't matter.

The FDA has told hospitals that it's not going to enforce this statute against them when they fiddle with a medical device for legitimate purposes. So long as hospitals don't do anything that would be considered fraud or quackery the FDA has publicly stated that it will look the other way. Under those circumstances - and given that a CPAP machine is going to have it's pressure reset by somebody if it's ever returned and transferred to another patient - I think the odds of the FDA going after you for resetting your pressures are pretty much equal to the odds of aliens descending from the sky next Tuesday to hand over a cure for every type of cancer. In other words, don't worry about it.

Ultimate answer: Yes, it's technically illegal under federal law to change your pressures but nobody in Washington is going to care.

2. Medicare and Insurance Fraud

This is the other place where you could break the law for messing with your pressure by yourself - and this one may just count.

All states and insurance company put out clearly defined statements on what is and is not a "covered service". Every single one of these statements I've seen specifically restricts covered services to medical devices as prescribed by a physician (or equivalent thereof) and distributed by a pharmacy, DME, etc.

Well, it should be obvious to everybody here that once you've changed your pressures your machine is no longer "as prescribed by a physician". Continuing to use that machine is therefore no longer a covered service. That means that any money billed to Medicare or your insurer for your CPAP care - be it in machine rental, mask replacement, etc - after you changed your pressure without telling anybody would technically constitute insurance fraud. In other words, it's illegal.

This is where you could, at least conceivably, end up in a world of hurt for mucking with your machine.

Although nobody is ever going to prosecute you for insurance fraud for messing with your machine, it's entirely possible that your insurance carrier could deny your benefits and drop your coverage if they find out you're doing it. That's especially true if they can make a case for your self-prescribed pressures exacerbating another condition. For instance, let's say you monkey with your machine and then end up in the ER with a serious respiratory infection. It's entirely possible that your insurer will argue that the infection was initiated or complicated by your changes to the CPAP machine. They could deny coverage for treating the infection and even go after you to recover the cost of the CPAP treatment itself. I seriously doubt such a scenario would ever play out, but it does happen to patients who refuse to take their meds, don't use their TMJ appliance, etc, so there's no reason it couldn't happen to somebody messing with their CPAP machine as well.

Ultimate answer: Yes, changing your pressure is technically against the law if your treatment is being paid for by insurance. Once again, however, there's very little chance anybody is going to care except your health care providers.

3. Using a Device Without a Prescription

This is the one that everybody always talks about. It's also the one that's the hardest to evaluate.

Using a drug or device without a prescription is almost always something that's regulated on a state-by-state basis. Every state has a statute about using prescription meds without an Rx. Whether there's an equivalent law in your state about prescription devices is a question that would take a couple of days of research to figure out. You'd have to pour through dozens of statutes and administrative regulations in each state to answer this one. Frankly, I just don't have the time to do that no matter how interested I am in this question.

So maybe your state has a law that says you can't use a medical device that's not specifically prescribed for you. Maybe it don't. I can't tell you. You'll have to dig up that answer for yourself.

Ultimate answer: Who knows? Might be legal or might be not. All depends on where you live.

I hope that serves to clear up the situation a little. Again, these are my own general opinions on what the law says. Do not try to apply anything here to your own individual situation. If you have a specific question about your own individual situation you'll need to find your own attorney to help you. I can't answer those types of questions.

I'm also hoping - although not expecting - that this thread won't turn into a political or philosophical debate on whether such laws should or should not exist. If you want to talk about that I hope that you'll start your own thread and leave this one on topic. I'd really like to see this remain a discussion about what laws are out there and what they mean. That said, I'm already preparing myself for the fireworks to start.

Hope this was useful.

Cheers,
XJ.

[robysue]

I've read this whole thread.

I've found xj's posts interesting, informative, well written, entertaining, and most certainly NOT troll-like or intentionally inflaming. At no point that I can find has he called patients "stupid" nor has he told anyone who advocates or admits that they've changed their own pressure as "dumb" or "stupid" or "reckless" in the way he who cannot be named kept doing on threads from not too long ago.

In particular, I think xj's whole point is summed up in his original post when he states:

So is it illegal to change your own pressure?

The answer is - maybe.

There's no clear law on this.

He's provided what seems to me to be a well written and thoughtful discussion of just how vague and broad much of the language of some of the relevant laws are. He's also stated that in the US there is likely to be variation from state to state. And he's pointed out that enforcement of any of the laws that potentially can be interpreted as saying "patient changing their own pressure setting is illegal" is a whole different can of worms and is most likely NOT going to happen by any CPAP police.

He has also brought up some interesting scenarios where a patient who adjusts their own pressure could well run into problems with their insurance or Medicare deciding to limit or deny coverage for medical conditions that might have been aggravated by the patient's adjusting their pressure without approval of their sleep doctor. I think these scenarios are worth serious consideration since under our current health care system insurance companies have much incentive to deny claims for any reason they regard as plausible and the patient who decides to contest the denial has a long, hard battle in front of them. And the whole idea of whether it is legal or illegal to change your pressure may or may not be moot if you're battling an insurance company's denial of coverage since a denial of coverage may be legal even if you did nothing technically illegal in changing your pressure---merely going against your doctor's orders may be enough for the insurance company to defend a decision to deny coverage.

[nobody]

How about you prove that anyone ever has been in legal trouble or even had insurance coverage denied solely because they changed the pressure on their own machine.

[ some of the interpretations of them

This is the problem with it, but hey if you want to believe this nonsense feel free. Just remember anybody can claim to be a lawyer online and offer up a bunch of legal sounding bullshit.

And you can prove this? You have the quotes of the laws? and the court rulings?

[xj220c]

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.

Cheers,
XJ.

PS - I know there's now going to be a ton a follow-ups about oppressive government regulation and how seat belts laws actually cost lives and money, blah, blah, blah. The point isn't whether the law should be there, the point is that this is how it works right now whether you agree with it or not. If you don't like wearing a seat belt write your governor, not me. XJ.

[nobody]

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.

Not wearing a seatbelt does nothing to improve your health, unlike changing the pressure on your CPAP could and probably will. The only thing that could potentially happen with not wearing a seat belt is harm, and yes there is potential for harm to people other than the unbelted person. I saw a car accident years ago where an unbelted passanger flew out the passenger window and struck a person on a sidewalk. Also, you're far more likely to be harmed riding in a car unbelted than changing the pressure on your CPAP.

[xj220c]

How about you prove that anyone ever has been in legal trouble or even had insurance coverage denied solely because they changed the pressure on their own machine.

I'm sorry, but this is just ridiculous logic.

I've never seen anybody in legal trouble for possessing a Gaboon viper. Does that mean that there are no laws against keeping venomous snakes?

I've never seen anybody in legal trouble for possessing VX nerve gas. Does that mean that there are no laws against possessing weapons of mass destruction?

I've never seen anybody in legal trouble for boosting the signal strength on their cell phone. Does that mean there are no FCC regulations that would prohibit it?

The fact that nobody's ever been prosecuted for something doesn't mean it's legal. As I said in my original post, I believe the law does make adjusting the pressure illegal, but that nobody except your doctors and insurance company is going to care. How is it that this statement is soooooo controversial for you?

Cheers,
XJ.

[SuperSleeper]

A member of this forum invited me to post a response here on cpaptalk, since I run another Sleep Apnea forum where we have openly distributed CPAP Clinician Manuals free-of-charge for about 4 years or so. Let me say first that I LOVE cpap-dot-com - I have purchased my previous two CPAP machines from them, including my new S9 AutoSet (love it!) and all my accessories here - and they provide excellent service and super prices. I was introduced to cpap-dot-com a long time ago by "Ted the Titrator" - many of you may remember him. I wish I could advertise the site on our main forum, but our rules prevent that. I do recommend them all the time in PMs and emails as much as I can.

On with my points... please forgive the introductory governmental treatise, but I feel that it's necessary to lay a foundation for why I believe we are within our rights to change our own CPAP pressure - and I can't argue it properly without building from the ground up...

1. Philosophy of Government: I myself am of the more "libertarian" or nearly "Jeffersonian" political leaning. Meaning, I believe in the Constitution, the unalienable rights of man given to us by our Creator - and that generally the government should get out of my life except where it is Constitutionally charged with protecting life, liberty and property. Our nation (the United States) has deviated tremendously from these ideals, in my opinion, resulting in the current mess with regard to healthcare issues.

2. Higher Laws: Our system of government gives more weight and deference to the "higher powers"; for instance, a lower court's ruling can be overturned by a higher court's ruling. Likewise, a law can be enacted by a lower government (city or county ordinance) which is complete opposition to the US Constitution (higher law) is not a proper or just law. In fact, (especially in extreme cases), I feel it is the duty of citizens to either ignore or disobey a law that is clearly unconstitutional. For instance, if a city were to ban religious worship or public speech, the citizenry should ignore that law, since the US. Constitution (higher power) protects the freedom of religion and the freedom of speech. The higher law should prevail. Notice I didn't say that the Constitution "gives us" our rights. No, it simply protects our rights. Our rights do not come from the US Constitution, but rather, (as the Declaration of Independence states) come from "our Creator".

3. Interaction between Life, Liberty and Property: Those are the three main rights proper government should concentrate on and protect. (the third one often is referred to as the "pursuit of happiness" which stems from property ownership). When government goes outside these three areas, it becomes destructive of the very rights it is charged with protecting.

For instance, I have a right to enjoy my backyard (my property). I can do pretty much whatever I want in my yard, as long as I don't violate the rights of others as I enjoy it. BUT, if I decide to start a huge out-of-control fire in my backyard which ultimate spreads to my neighbors house, I have then violated my neighbor's right to his property (and possibly my neighbor's right to life, if the fire burns his house down with him inside it). Government should only get involved if the free exercise of my own rights violates the life, liberty or property of another citizen.

Likewise, I can't exercise my "free speech" by yelling "FIRE!" in a crowded theater when there is no fire. Why? Because I would be violating the rights of movie-goers to enjoy the property (they paid the theater owner to enjoy the entertainment offered on his property, and have a contractual right to sit there for the duration of the movie).

Okay, I think you get it... now, how does this apply to the right for someone to change his/her own CPAP pressure?

As a United States citizen, I don't plan on complying with an unconstitutional law or one that is in direct opposition to the basic, fundamental rights of man. In fact, I think I have a duty to disobey such a "law" because it is not a just or proper law.

I couldn't care less about a city, county, state or federal law that (by complying with it) risks my health (and possibly my life). Also, I couldn't care less about a law that ignores and violates my right to my own property.

Perhaps a more socialistic-leaning philosopher would argue that "the government is enacting CPAP laws" to "protect me from myself". After all, (the argument goes), "I might hurt myself". So the government, (they say) is "protecting my life". There's only one problem with this: by the government "protecting" my life, they are inadvertently restricting my right for me to use my property as I see fit. They have violated one right to protect another. This is why in the above paragraph, I said that government should only get involved if the free exercise of my own rights violates the life, liberty or property of another citizen. It should not get involved if I am only "violating" my own rights - after all, if I choose to restrict myself, that's my business, as long as I'm not hurting other citizens.

For these reasons, I believe we are within our rights to change our own CPAP pressure (assuming we own the machine). As long as I am not directly harming another person, and as long as there is no immediate threat to the life, liberty or property of another citizen, no government has no right to restrict my freedoms, including telling me that I can't change my own CPAP pressure. To do so would be a violation of my property rights and possibly a violation of my right to life (doing what is best for my own health and safety).

If forced to make a choice between obeying a "lower law" (federal law) and obeying a "higher law" (the laws of God, or as some would say the laws of Nature), I choose to obey the higher law. My right to life and property trumps any man-made law, period, as long as I don't violate someone else's God-given rights. The creation of new federal codes and statutes really does nothing to alter or abolish my fundamental rights.

I don't ask permission from anyone when I choose to exercise my rights, period. That's why on our website and forum, we will continue to freely distribute the information necessary for CPAP users to exercise their own property rights, and that's why I applaud this site when it allows the free sharing of this information. The "fair use" of the copyrighted manuals includes the right to use the machine to it's fullest capacity, as long as the patient has paid for, and owns his/her own CPAP machine outright.

SuperSleeper

"Experience hath shewn, that even under the best forms of government those entrusted with power have, in time, and by slow operations, perverted it into tyranny". - Thomas Jefferson

[nobody]

I've never seen anybody in legal trouble for possessing a Gaboon viper. Does that mean that there are no laws against keeping venomous snakes?

I guess you should do more research. In some places in the USA it's illegal to keep a dog without a license yet legal to keep venomous snakes, lions, tigers, and all manner of other exotic "pets".

The fact that nobody's ever been prosecuted for something doesn't mean it's legal.

There are all sorts of ridiculous laws that nobody enforces because it would be ridiculous in today's society.

As I said in my original post, I believe the law does make adjusting the pressure illegal,

Just because your creative interpretation of the law makes you think it's illegal to change the pressure on your own CPAP doesn't mean it actually is.

How is it that this statement is soooooo controversial for you?

Maybe I'm sick of seeing this same tired argument every time I come here.

[BlackSpinner]

For these reasons, I believe we are within our rights to change our own CPAP pressure (assuming we own the machine). As long as I am not directly harming another person, and as long as there is no immediate threat to the life, liberty or property of another citizen, no government has no right to restrict my freedoms, including telling me that I can't change my own CPAP pressure. To do so would be a violation of my property rights and possibly a violation of my right to life (doing what is best for my own health and safety).

What you believe is one thing, actual law and its practice is another thing all together.
You have the right to believe what you want and you may chose to break these laws but you can still get arrested when you do - this is commonly called political activism and is fine as far as I am concerned - for more then 3 generations my family has participated in this. But don't come whining when the law lays its hand on your shoulder - you make the choice, you take the risk and you pay the price - that is how it works.

Don't confuse the two.

[howkim]

Interesting. But xj displays a fundamental lack of understanding of the FDA, its processes and general philosophy. That's only a comment, not a criticism. That kind of knowledge is hard to come by.

1. Adulterating a Medical Device

Federal law, 21 USC § 331(b) to be precise, prohibits "(t)he adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce."

Ultimate answer: Yes, it's technically illegal under federal law to change your pressures but nobody in Washington is going to care.

Actually, under this criterion the answer is probably no. FDAese is a distinct dialect of both English and Legalese. There are some nuances that it takes one experienced in reading the FDA gibberish to understand it, lawyer or not. Adulteration of a device would entail changing the manner that the machine functions according to the approval documentation. Because it was approved as a device with a feature enabling it to deliver air pressure within a defined range of pressures, changing the setting of the device for pressures within that range is probably fine. However, changing the device so that it delivers a pressure outside of the approved range would be adulteration of the device. Changing the device so that it delivers only one pressure, and not a defined range of pressures, would be adulteraing it.

... Well, it should be obvious to everybody here that once you've changed your pressures your machine is no longer "as prescribed by a physician".

Unless you changed the settings at the direction of the physician, without the intervention of the DME.

This is where you could, at least conceivably, end up in a world of hurt for mucking with your machine.

I totally agree

3. Using a Device Without a Prescription

Unless of course, the doc told you to change it.