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.
Why it IS illegal - sort of - to change your pressure.
Re: Why it IS illegal - sort of - to change your pressure.
1. Adulterating a Medical Device
No, you're not selling them. You've been prescribed the thing and it is yours - you can do whatever you want with it. You can have it blow air in your ear - no one will come after you for that. You can use it to blow up balloons at birthday parties - whatever. Now if you give it to someone else, that's a different story - but not because you changed the settings.
2. Medicare and Insurance Fraud
No again, you are the patient and can do whatever you want. Medicare funds are paid to providers not to patients. Providers can be fraudulent - and unless you obtain something fraudulently as a patient - then you are OK. If you get a prescription enema and use it by drinking it, you are not guilty of doing anything wrong. It's your body. It may be stupid, but not illegal. If you sold it as a beverage, that may get you into trouble.
3. Using a Device Without a Prescription
You have a prescription. You have a machine. You can do anything you want.
The bottom line is that you can look for little green men in dark suits, but you are doing nothing illegal. Nothing. Even if it were, do you think that there is anyone out there who would care?
Most of what you have talked about pertain to selling medical items and dispensing them. We haven't yet grown into such an oppressive society that you can be prosecuted for using them as you wish. Wait until the next presidential election - you never know what will come down these days. At least for now - we are with within our rights.
No, you're not selling them. You've been prescribed the thing and it is yours - you can do whatever you want with it. You can have it blow air in your ear - no one will come after you for that. You can use it to blow up balloons at birthday parties - whatever. Now if you give it to someone else, that's a different story - but not because you changed the settings.
2. Medicare and Insurance Fraud
No again, you are the patient and can do whatever you want. Medicare funds are paid to providers not to patients. Providers can be fraudulent - and unless you obtain something fraudulently as a patient - then you are OK. If you get a prescription enema and use it by drinking it, you are not guilty of doing anything wrong. It's your body. It may be stupid, but not illegal. If you sold it as a beverage, that may get you into trouble.
3. Using a Device Without a Prescription
You have a prescription. You have a machine. You can do anything you want.
The bottom line is that you can look for little green men in dark suits, but you are doing nothing illegal. Nothing. Even if it were, do you think that there is anyone out there who would care?
Most of what you have talked about pertain to selling medical items and dispensing them. We haven't yet grown into such an oppressive society that you can be prosecuted for using them as you wish. Wait until the next presidential election - you never know what will come down these days. At least for now - we are with within our rights.
Re: Why it IS illegal - sort of - to change your pressure.
as for the law, in this case, I would be rooting for it to become moot due to the following..
first... all patients need to be informed...
they should be sent to cpap classes and taught everything they need to know about how to optimize thier therapy, and
how to use their machines..
second.. the docs need to be partners with their informed patients and let them experiment with what works best
third.. the dme's need to quite lying about the data in the machines, because they are motivated by the money they get to serve
as "magical" downloaders..
I can only imagine if diabetics were treated like idiots, and told they could only see averages on their bg meters.. and they had to guess
how much insulin they needed, and what if they had to run to a DME to download their meters? can you friggen imagine?
They would put their meters in the closet where so many apneas stuff their machines..
and a lot of them would be DEAD... I just shiver when I think of how many apneans who have put their machines in the closet and died
of osa complications..
sleep medicine is so TWISTED!
thanks for doing all the research on this <pat on head>
first... all patients need to be informed...
they should be sent to cpap classes and taught everything they need to know about how to optimize thier therapy, and
how to use their machines..
second.. the docs need to be partners with their informed patients and let them experiment with what works best
third.. the dme's need to quite lying about the data in the machines, because they are motivated by the money they get to serve
as "magical" downloaders..
I can only imagine if diabetics were treated like idiots, and told they could only see averages on their bg meters.. and they had to guess
how much insulin they needed, and what if they had to run to a DME to download their meters? can you friggen imagine?
They would put their meters in the closet where so many apneas stuff their machines..
and a lot of them would be DEAD... I just shiver when I think of how many apneans who have put their machines in the closet and died
of osa complications..
sleep medicine is so TWISTED!
thanks for doing all the research on this <pat on head>
_________________
| Mask: Swift™ FX Nasal Pillow CPAP Mask with Headgear |
| Humidifier: S9™ Series H5i™ Heated Humidifier with Climate Control |
| Additional Comments: sleep study: slept 66 min in stage 2 AHI 43.3 had 86 spontaneous arousals I changed pressure from 11 to 4cm now no apap tummy sleeping solved apnea |
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Laurie1041
- Posts: 162
- Joined: Sat Oct 23, 2010 10:24 pm
- Location: Kentucky
Re: Why it IS illegal - sort of - to change your pressure.
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.
The FDA is federal so any statutes concerning medical devices would be applicable to all 50 states.
The only scenario concerning self-directed xPAP system changes that would have the greatest potential of possibly coming to bite the free-minded and enterprising xPAP user is with private or Medicare insurance. Consider this example. A patient is seen in the ED for severe shortness of breath, elevated temperature, and malaise. The examining physician states in his notes, "Patient states he has OSA and is on xPAP therapy x 2 years. Patient further states he changed his xPAP settings from x cm to x cm about 1 month ago. Approximately 2 weeks ago patient states he developed a persistent cough, and is expectorating copious amounts of yellow sputum. Patient's temp is 101.2, respiratory rate is 27 and shallow, HR 111. Further on chest x ray it is noted that patient has bilateral infiltrates and left lower lobe consolidation. Dx: Bilateral pneumonia most likely related to patient increasing the pressure settings on his xPAP device. Patient counseled on importance of using his xPAP per his doctor's orders. Patient started on IV antibiotics, 02, and bedrest. Prognosis is good if patient remains compliant and follows up with his sleep doctor. Copy of this dictation is being sent to Dr. Formeldehyde, patient's sleep doctor. "
I think the best way around this whole conundrum is to have an open and honest rapport with one's sleep doctor and get his or her "buy in" towards the patient having certain leeway in changing their pressure settings based on how they are feeling. I have not broached this subject with my doctor, yet, but I will definitely let my doctor know that I changed by pressure settings and give him the rationale why.
The FDA is federal so any statutes concerning medical devices would be applicable to all 50 states.
The only scenario concerning self-directed xPAP system changes that would have the greatest potential of possibly coming to bite the free-minded and enterprising xPAP user is with private or Medicare insurance. Consider this example. A patient is seen in the ED for severe shortness of breath, elevated temperature, and malaise. The examining physician states in his notes, "Patient states he has OSA and is on xPAP therapy x 2 years. Patient further states he changed his xPAP settings from x cm to x cm about 1 month ago. Approximately 2 weeks ago patient states he developed a persistent cough, and is expectorating copious amounts of yellow sputum. Patient's temp is 101.2, respiratory rate is 27 and shallow, HR 111. Further on chest x ray it is noted that patient has bilateral infiltrates and left lower lobe consolidation. Dx: Bilateral pneumonia most likely related to patient increasing the pressure settings on his xPAP device. Patient counseled on importance of using his xPAP per his doctor's orders. Patient started on IV antibiotics, 02, and bedrest. Prognosis is good if patient remains compliant and follows up with his sleep doctor. Copy of this dictation is being sent to Dr. Formeldehyde, patient's sleep doctor. "
I think the best way around this whole conundrum is to have an open and honest rapport with one's sleep doctor and get his or her "buy in" towards the patient having certain leeway in changing their pressure settings based on how they are feeling. I have not broached this subject with my doctor, yet, but I will definitely let my doctor know that I changed by pressure settings and give him the rationale why.
_________________
| Mask: Mirage Activa™ LT Nasal CPAP Mask with Headgear |
| Humidifier: S9™ Series H5i™ Heated Humidifier with Climate Control |
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SleepTechulous
Re: Why it IS illegal - sort of - to change your pressure.
This is really a silly topic but I love the fact that we are settling in for a real legal debate so I'll jump in here. Firstly, this is just my opinion. As you may know, regarding the law, everything is subject to perspective and subject to change. You've done a ton of work on this, kudos.
1. Adulterating a Medical Device
I know which law you are talking about but I really don't see it man. It has never been used for this purpose and has only been used a handful of times against pharmaceutical companies. For the most part it doesn't even appear to be so much a criminal offense as a civil one so the worst that could happen would be a fine. Given that we are speculating or hypothesizing a single incident that fine would be extremely small... if it were even pursued at all. Even then it would be a hard case to argue.
2. Medicare and Insurance Fraud
We have to deal with Medicare guidelines all the time at work so I feel it here. As a government agency Medicare really does not have to have a reason to penalize anyone. They rarely prosecute people however and typically stick to summary fines and penalties against businesses and corporations. The only significant cases they have made outside of that is cases of outright fraud. It is hard enough to argue that a sleep lab is billing them with out providing services much less explain cpap use to them. With out pure-intentional, pre-planned fraud resulting in the financial gain of the patient at the financial loss of the government I really don't think you could generate much interest from medicare.
3. Using a Device Without a Prescription
This one really interests me because it would depend entirely upon the wording of the state law and as we all live in different states there is no telling how a case like this could play out. Most laws of this type revolve around illegal use of contraband substances which are allowed via prescription however a prescription device may be a bit less understood by the courts and they could very well try to lasso it in.
As always, although I do not condone the unauthorized use of CPAP equipment I must state that should you come under legal inquisition from state or federal authorities. Shut your mouth and get a lawyer. Any good lawyer could eat these charges for breakfast.
1. Adulterating a Medical Device
I know which law you are talking about but I really don't see it man. It has never been used for this purpose and has only been used a handful of times against pharmaceutical companies. For the most part it doesn't even appear to be so much a criminal offense as a civil one so the worst that could happen would be a fine. Given that we are speculating or hypothesizing a single incident that fine would be extremely small... if it were even pursued at all. Even then it would be a hard case to argue.
2. Medicare and Insurance Fraud
We have to deal with Medicare guidelines all the time at work so I feel it here. As a government agency Medicare really does not have to have a reason to penalize anyone. They rarely prosecute people however and typically stick to summary fines and penalties against businesses and corporations. The only significant cases they have made outside of that is cases of outright fraud. It is hard enough to argue that a sleep lab is billing them with out providing services much less explain cpap use to them. With out pure-intentional, pre-planned fraud resulting in the financial gain of the patient at the financial loss of the government I really don't think you could generate much interest from medicare.
3. Using a Device Without a Prescription
This one really interests me because it would depend entirely upon the wording of the state law and as we all live in different states there is no telling how a case like this could play out. Most laws of this type revolve around illegal use of contraband substances which are allowed via prescription however a prescription device may be a bit less understood by the courts and they could very well try to lasso it in.
As always, although I do not condone the unauthorized use of CPAP equipment I must state that should you come under legal inquisition from state or federal authorities. Shut your mouth and get a lawyer. Any good lawyer could eat these charges for breakfast.
Re: Why it IS illegal - sort of - to change your pressure.
Proof that the "legal thinking" is wrong:
I was told by the California agency regulating RTs that you are entitled to provide self care pursuant to subdivision (b) of Section 3765 of the California Business and Professions Code which provides:
3765. This act does not prohibit any of the following activities:
... (b) Self-care by the patient or the gratuitous care by a friend or member of the family who does not represent or hold himself or herself out to be a respiratory care practitioner licensed under the provisions of this chapter.
I was told by the California agency regulating RTs that you are entitled to provide self care pursuant to subdivision (b) of Section 3765 of the California Business and Professions Code which provides:
3765. This act does not prohibit any of the following activities:
... (b) Self-care by the patient or the gratuitous care by a friend or member of the family who does not represent or hold himself or herself out to be a respiratory care practitioner licensed under the provisions of this chapter.
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SleepTechulous
Re: Why it IS illegal - sort of - to change your pressure.
Thats a bit different.Kevin G. wrote:Proof that the "legal thinking" is wrong:
I was told by the California agency regulating RTs that you are entitled to provide self care pursuant to subdivision (b) of Section 3765 of the California Business and Professions Code which provides:
3765. This act does not prohibit any of the following activities:
... (b) Self-care by the patient or the gratuitous care by a friend or member of the family who does not represent or hold himself or herself out to be a respiratory care practitioner licensed under the provisions of this chapter.
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timbalionguy
- Posts: 888
- Joined: Mon Apr 27, 2009 8:31 pm
- Location: Reno, NV
Re: Why it IS illegal - sort of - to change your pressure.
Here are my thoughts on this interesting post:
1. Adulterating a medical device.
Even though the pressure settings are hidden in a 'clinician's menu', I have yet to see a machine where this menu is anything more than the least bit hidden. I bet many users find it by themselves one day when they accidentally hit the wrong combination of buttons. Inside this menu, the range of settings for the machine is constrained by firmware. Although not all settings may deliver effective therapy, all settings given are within range of the machine's performance potential (and the machine may prevent you from setting truly useless combinations-- like IPAP less than EPAP on a bilevel). You are not 'altering the firmware' of the machine with these settings. Strictly speaking, 'firmware' is the code burned into the chips inside the machine that can only be altered by replacing the chips, or by a special maintenance procedure that is outside the scope of normal operation. (That said, user firmware upgrades are possible with some machines.)
'Adulteration' is normally defined as 'making some change to something that makes it not what it is advertised to be'. That certainly doesn't apply to pressure setting changes on a xPAP machine.
2 and 3. I have no comments on at this time.
1. Adulterating a medical device.
Even though the pressure settings are hidden in a 'clinician's menu', I have yet to see a machine where this menu is anything more than the least bit hidden. I bet many users find it by themselves one day when they accidentally hit the wrong combination of buttons. Inside this menu, the range of settings for the machine is constrained by firmware. Although not all settings may deliver effective therapy, all settings given are within range of the machine's performance potential (and the machine may prevent you from setting truly useless combinations-- like IPAP less than EPAP on a bilevel). You are not 'altering the firmware' of the machine with these settings. Strictly speaking, 'firmware' is the code burned into the chips inside the machine that can only be altered by replacing the chips, or by a special maintenance procedure that is outside the scope of normal operation. (That said, user firmware upgrades are possible with some machines.)
'Adulteration' is normally defined as 'making some change to something that makes it not what it is advertised to be'. That certainly doesn't apply to pressure setting changes on a xPAP machine.
2 and 3. I have no comments on at this time.
Lions can and do snore....
Re: Why it IS illegal - sort of - to change your pressure.
Thanks for posting a rebuttal that has some reasoning to it other than "you're wrong because I say you're wrong." That's refreshing on the net these days!timbalionguy wrote:Adulteration' is normally defined as 'making some change to something that makes it not what it is advertised to be'. That certainly doesn't apply to pressure setting changes on a xPAP machine."
I know my answer to this is going to fly past most people here, but I think your argument deserves a response. Here's the logic I'd rely on for adulteration:
The law defines a medical device as being "adulterated" under 21 USC § 501 as any device "declared to be, purports to be, or is represented as, a device that is in conformity with any standard recognized under 21 USC § 351 unless such device is in all respects in conformity with such standard."
CPAP machines are regulated as Class II medical devices so they are therefore subject to the § 351 standards requirements. Part of those standards relate to software risk analysis as specified for 510(k) eligible devices in FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Those standards assume that the device is going to be used as described in the PMA and 510(k) submissions within the boundaries of the intended use.
For CPAP machines that means that the software is validated assuming that only the clinical staff have access to the pressure settings. If it wasn't that way the manufacturer would have to perform safety analysis and testing under conditions where the patient has unfettered control of the pressure. That clearly wasn't done - at least not in any of the PMA/510(k) docs I've seen for CPAP machines.
So . . . once the patient accesses the clinician's menu and changes the pressures that device is being modified outside the scope of the intended use under which it was approved. Under FDA's Guidance to Industry on Modifications to Class II and III Medical Devices (or something such - I can't find it right now to get the exact title) ANY modification to the device's software, firmware, or operational settings that occurs outside the intended use boundaries constitutes adulteration.
Ergo, if somebody other than clinical staff gets into a CPAP machine and mucks with it the FDA considers it to be adulterated within the meaning of the statute.
At least that's how I read it. I know that there's no hard decisions on this and others may legitimately disagree and say that the scope of the guidance was intended to cover only calibration settings and doesn't apply to settings and software under field use. It's a nasty little problem of regulatory interpretation. I think that you would really need a guidance from the FDA before you would know what their stand on it was.
That all said, as we both agree, it's not much more than an interesting academic argument given that nobody would ever come near an enforcement action on something like this. In the end, however, the FDA has told hospitals that it's adulteration to mess with device settings outside the intended use guidelines. I think you have to carry that guidance over to the CPAP machine as well.
I also have to say that I don't really buy your "advertised to be" reasoning. I could easily make the argument that an individual machine is "advertised to be" set up exactly as the physician's prescription specified it to be. Once the pressure is changed I don't think you can say that.
I also understand your technical point about firmware vs. settings. Once way or another, though, those settings are going to be stored in non-volatile memory and read in with the firmware during use. I guess there's a technical distinction there but it all ends up in controller memory and affects device performance so I think it's really a distinction without a difference.
Cheers,
XJ.
Re: Why it IS illegal - sort of - to change your pressure.
The section of the California regs you quote deals with licensing of clinical workers. It has nothing to do with use of medical devices. It only says that the state can't fine you for practicing respiratory care without a license if you treat yourself. You're looking at a part of the law that's totally unrelated to the question at hand.Kevin G. wrote:Proof that the "legal thinking" is wrong:
I was told by the California agency regulating RTs that you are entitled to provide self care pursuant to subdivision (b) of Section 3765 of the California Business and Professions Code which provides:
As for jonquiljo's comments . . . well . . . you're just way off on the legal points.
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.
Re: Why it IS illegal - sort of - to change your pressure.
Denial is forever.
The section of the California Codes I quoted was provided by the agency regulating RT's in direct response to my question about adjusting my machine. They were very clear that the patient has the right to adjust his own machine.
You have only provided conjecture and then you reject an inconvienient fact.
There is a saying that you should never argue with an attorney, it is like wrestling with a pig in mud. After a while, you realise the pig likes it. I do not enjoy the mud.
The section of the California Codes I quoted was provided by the agency regulating RT's in direct response to my question about adjusting my machine. They were very clear that the patient has the right to adjust his own machine.
You have only provided conjecture and then you reject an inconvienient fact.
There is a saying that you should never argue with an attorney, it is like wrestling with a pig in mud. After a while, you realise the pig likes it. I do not enjoy the mud.
Re: Why it IS illegal - sort of - to change your pressure.
That line is a template that appears in many states' licensure laws:xj220c wrote:The section of the California regs you quote deals with licensing of clinical workers.
http://www.rilin.state.ri.us/statutes/T ... 3-39-4.HTM
http://www.leg.state.vt.us/statutes/ful ... hapter=091
http://www.legis.state.wv.us/wvcode/cod ... =30&art=34
West Virginia has an interesting line:
However, given that line's ("Self-care by the patient or the gratuitous care by a friend or member of the family who does not represent or hold himself or herself out to be a respiratory care practitioner") location in the statutes, I believe your interpretation is correct-- if one decides to wing their dials around, they wouldn't get arrested for practicing Respiratory Care without a license.§30-34-16. Practice of medicine prohibited.
Nothing in this article may be construed to permit the practice of medicine.
"Don't Blame Me...You Took the Red Pill..."
Re: Why it IS illegal - sort of - to change your pressure.
I choose to believe that 'adulteration' is not what we do when we change pressures in any case. What we do is adjust, or re-adjust pressures within the confines of a design set-up to be adjusted, within a range already provided (whether or not it is "hidden" from some people), whereas adulteration (to me) would be changing the actual machinery to become something else entirely - "tweaking" the innards to operate entirely differently vs changing the degree of usage on an already existing scale.
So, to use your own logic, this could not be called illegal as it is not adulterating anything!
So, to use your own logic, this could not be called illegal as it is not adulterating anything!
Re: Why it IS illegal - sort of - to change your pressure.
Clearly, adulteration is most states is illegal as well as amoral, especially if it involvesJulie wrote:I choose to believe that 'adulteration' is not what we do when we change pressures in any case. What we do is adjust, or re-adjust pressures within the confines of a design set-up to be adjusted, within a range already provided (whether or not it is "hidden" from some people), whereas adulteration (to me) would be changing the actual machinery to become something else entirely - "tweaking" the innards to operate entirely differently vs changing the degree of usage on an already existing scale.
So, to use your own logic, this could not be called illegal as it is not adulterating anything!
"tweaking" the innards
"Don't Blame Me...You Took the Red Pill..."
Re: Why it IS illegal - sort of - to change your pressure.
Perhaps I am, but the fact is that no one gives a damn about this stuff but the lawyers - and they are the instruments not the law. I have heard more than my share of attorneys tell me what can and cannot be done - when in principle, anything can be done as long as no one takes an objection to it - that is anyone in any position to object. I have lost a bundle simply because it was too expensive to prove my case.xj220c wrote:Kevin G. wrote: As for jonquiljo's comments . . . well . . . you're just way off on the legal points.
Unless you stand liable for criminal or civil charges - the "reality" of the law is that you do what you can get away with - law or not. Just don't go to jail. Also along those lines is the reality that in civil court that it matters very little whether you are right or wrong vs. your opponent - it matters whether you want to pay through the nose proving your case. Most civil litigation never gets past the complaint stage for just that reason. It's a game of "chicken" with legal fees as the limiting factor - hence the lawyers are the ones that mostly profit. It doesn't matter how "correct" you are, it matters who wants to take a piece out of you and how hard they are willing to go to get there. Someone always backs down in the end - at least most of the time.
Criminal offenses are a little different, but things can be illegal that are of such little importance that no one will ever deal with that point of law. There are bigger crimes than misuse of a CPAP machine! I'll worry when they start up the "CPAP Police". Until then, I will change my pressure as I wish. If Respironics wants to sue me, then well .... my liability umbrella will keep me from harm - and keep them from giving me any grief.