State law in Ct.

Here are some additional interesting "is it illegal?" discussions:

cpap pressure setting - topic started by guest "jlc"
viewtopic.php?t=3366

Is it Illegal to Change Settings on One's CPAP Machine? - topic started by sleepguide
viewtopic.php?p=346547#p346547

Are Clinician Manuals Illegal - topic started by RN Ricky
viewtopic.php?p=434363#p434363

Disclaimer: My background is in Sleep Medicine and NOT in legal matters.

The explanation I've been given by different physicians and practitioners is this:

A prescription is a doctor's implementation of their best understanding of a patient's therapeutic needs. The prescription often includes the PAP model, Interface Model, pressure settings and additional PAP variables. Because these are written in the prescription, that is the official therapy that patients are enabled to use. Going off prescription, whether it be for pressure settings or switch from FF to nasal mask, is using the medical device in a manner not intended by the physician.

Consider the analogy of using Ambien at a different dosage than the prescription that your doctor advised. Is it illegal to use outside their prescription, yes. Are you likely to get caught, no. Are you following their best guidance for your wellbeing, no. It's a stab in the dark at improving pressures compared to the pressures used during your titration in a lab (which hopefully most patients are able to do).

Whether or not you morally agree with the way our FDA and Prescription Laws work in the US is a different argument.

On a side note, it's a poor reflection on the sleep community (and especially the DME providers) that all your questions went unanswered about the details of why it would be illegal to use PAP equipment outside of your doctor's prescription.

Hope this helps resolve any misunderstandings and check with reputable CPAP sellers, they have a financial interest in requiring prescriptions because of the possible legal ramifications (which is the same reason they shouldn't modify pressure settings without a modified prescription).

-Polysomning

Is it illegal to use outside their prescription, yes.

-Polysomning[/quote]

Please show me where it is WRITTEN as a law. As to taking a pill that was prescribed b y my doctor and if I took an overdose, does what you say mean I would be charged for taking an overdose----- B....S.....!!!!!!

What you wrote might be of value in deciding whether or not a patient chooses to adjust his pressures or not, it says absolutely nothing to answer the original question: Is it illegal for a patient to change his settings? Nobody (that I have seen) has ever posted a link to show an actual law on the books stating that this is against the law. We have read lots of illustrations, 'for examples', hypotheticals, and 'what-ifs?', generally condescending in nature. We have been told 'I don't know where it is written, but I was told that....' But we have never been able to read an actual law. The challenge is still open: Please show us an actual, living, breathing law.

Thanks,
Tony

Polysomning wrote:Disclaimer: My background is in Sleep Medicine and NOT in legal matters.

The explanation I've been given by different physicians and practitioners is this:

A prescription is a doctor's implementation of their best understanding of a patient's therapeutic needs. The prescription often includes the PAP model, Interface Model, pressure settings and additional PAP variables. Because these are written in the prescription, that is the official therapy that patients are enabled to use. Going off prescription, whether it be for pressure settings or switch from FF to nasal mask, is using the medical device in a manner not intended by the physician.

Consider the analogy of using Ambien at a different dosage than the prescription that your doctor advised. Is it illegal to use outside their prescription, yes. Are you likely to get caught, no. Are you following their best guidance for your wellbeing, no. It's a stab in the dark at improving pressures compared to the pressures used during your titration in a lab (which hopefully most patients are able to do).

Whether or not you morally agree with the way our FDA and Prescription Laws work in the US is a different argument.

Hope this helps resolve any misunderstandings and check with reputable CPAP sellers, they have a financial interest in requiring prescriptions because of the possible legal ramifications (which is the same reason they shouldn't modify pressure settings without a modified prescription).

-Polysomning

I am feeling much more comfortable now...

My prescription is for CPAP with a pressure range from 5 - 18 cm H2O. After dialing things in, I find that I am within that range.

Unfortunately, the sleep doctor does not seem to be interested in narrowing things down to optimize the treatment. Unfortunately, the sleep doctor does not think that follow up is needed. Fortunately, I was able to educate myself about this condition, and take charge of my treatment - including dialing in a pressure that works better than running with a wide range.

If sleep doctors spent a little time developing a relationship with their patients and educating them, I think most people would run questions about adjusting settings by them to make sure the treatment is on course. Unfortunately, most people are not independently wealthy and since insurance doesn't cover questions like this, the doctor either works for free, or people take matters into their own hands. Now some of the blame is also shared with the DME, but since the "nasty stuff" rolls down hill, I prefer to concentrate on the top person which is the doctor.

I hire a medical team to help me with my health. I listen carefully to their advice and recommendations, but in the end it is my health and I live or die by my decisions.

Polysomning wrote: . . . all your questions went unanswered about the details of why it would be illegal to use PAP equipment outside of your doctor's prescription. . . .

I will politely disagree with you, by pointing out the the question was answered perfectly, in that no one, including you, has ever been able to produce a copy of ANY law that you (without expertise or proof, based on nothing more than hearsay) apparently still claim would allegedly make it "illegal" for a patient to change his or her own pressure.

I wonder, though: Are you suggesting that the doctors who allow patients to change pressures for themselves are all complicit criminals? I believe that the doctors who read this board might be interested on your basis for that, if that is your belief.

My understanding (similarly without expertise or proof, based on nothing more than hearsay) is that the laws of informed consent make it just as illegal for any medical person to force a particular pressure down my throat as it would be for them to tie me down and force a particular dose of a pill down my throat, except in certain highly exceptional circumstances, if we are going to stoop to the drug analogy outright.

Or is it your claim that my agreeing to PAP therapy somehow implies my forfeiting my right to bodily integrity?

I choose to work with doctors who allow me some say in my treatments. PAP is no exception. If a doctor isn't good with that, I would choose a different doctor. Neither my sleep doctor nor my primary care physician has any trouble with my adjusting my own pressure. In fact, my primary care physician encourages it. Is it your position that I am obligated to turn them in to the authorities for their radical (and as implied by you, criminal) departure from accepted medical practice?

Oh well, I guess that's what I'll have to do--write the authorities about my doctors' position on this matter to turn them both in. To whom exactly would you recommend that I address that letter, if there is someone out there that you think would get a good chuckle from my sending it?

1. Know what you are doing and the ramifications - educate yourself.
2. Play away - nobody is going to chase you. Dump the stupid supplier asap.
3. If not for this forum and the information gathered over a period of months I can assure you that my AHI would NOT be 0.00 each and every morning. Nor would I have discovered the need for supplemental oxygen in minute amounts during the night.


My insurance company is telling me that it is ileegal for them to pay for my prescribed medical equipment as the government has not kicked in their portion, even though with government aid the price for my gear would be in the order of $2500 for the blower and rental only for the oxygen concentrator at $400 a month (I bought the whole damn thing for $600... lessee, that would be 1.5 months payback). Sound like graft and corruption to you. Sure does to me. Supported by the LIBERAL government in power in Ontario. Our election at the Federal level this week decimated the Liberals; they are no longer even an official opposition party in Canada at the federal level and so it should be. I suspect as soon as we can get a provincial election running the same will happen. Good riddance I say.

Polysomning wrote:A prescription is a doctor's implementation of their best understanding of a patient's therapeutic needs. The prescription often includes the PAP model, Interface Model, pressure settings and additional PAP variables. Because these are written in the prescription, that is the official therapy that patients are enabled to use. Going off prescription, whether it be for pressure settings or switch from FF to nasal mask, is using the medical device in a manner not intended by the physician.

My opinion: Regarding CPAP machines... "using the medical device in a manner not intended by the physician" may be unwise for some people to do, but there is a big difference between something being unwise to do, or actually being illegal to do...in one's own therapy decisions.

Our election at the Federal level this week decimated the Liberals; they are no longer even an official opposition party in Canada at the federal level and so it should be. I suspect as soon as we can get a provincial election running the same will happen. Good riddance I say.[/quote]

Murray
I think we are going to have to get rid of Bob Ray before anything new happens on the Federal Liberal front. I heard this morning from an Ontario relative that they (Liberals) are grooming Justin Trudeau for the head job. Hmmmmmmm
Cheers from the progressive west .
Nan

I really, really promise that it's not illegal for a patient to change his own machine settings.

It probably *does* violate a regulation or at least a practice guideline for a tech to change settings without a prescription or order to do so. I seriously doubt there's a law on the books anywhere that addresses this, but a regulation or policy is quite plausible. People in healthcare tend to be rule-driven, so knowing that a regulation says a tech can't change settings without an order could get transmogrified to "it's illegal for a patient to do." It's also the case that contracts and policies with suppliers are likely to prevent DME's from supplying end-users with clinical manuals or information unique to clinical manuals. This doesn't even have the force of a regulation or public policy, but could well be misidentified as a "law."

I've been told plenty of times that it's "illegal" for me to prescribe a drug off-label or exceed some recommended dose, usually by a phone drone at an insurance company. I once said I needed them to talk to the hospital's lawyer (who happened, for coincidental reasons, to be in my office at the moment and was a practice partner of a justice of the US Supreme Court) because being accused of a crime involving medical practice was very serious to me and I needed details about what charges they were planning to file, in what jurisdiction, and when. I got an apology call soon thereafter from some sort of supervisor.

The worst part is that people who say this stuff believe it.

mstevens wrote: . . . It probably *does* violate a regulation or at least a practice guideline for a tech to change settings without a prescription or order to do so. . . .

Actually, the techs (RPSGTs) change other people's pressures all night before a prescription for a specific treatment pressure is even written. It's called a titration. Maybe that's why the RTs were trying to get all the techs fired?

Disclaimer again: I'm in healthcare, not a lawyer. But this is an interesting topic worth digging into

Link in CPAPTalk.com addressing this issue: http://goo.gl/HAYiU

FDA Regulations Title 21:Chapter I:Part 801: http://goo.gl/EQsXG

Thanks to @rested gal's post and ~SWS

Exerpt:

Sec. 801.109 Prescription devices.

A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device...

It follows that the legal ramifications could be constructed as "acting without an appropriate medical license to direct the use of device."

Do I know any patients that have ever faced legal consequences from changing their PAP pressure(s), no.
Does this fact change the legal position of the FDA on "directing device use without an appropriate license", no.

@mstevens - Interesting distinction between regulation and legality... running out of time but would like to discuss it more thoroughly. Thx for bringing it up.

@JNK

I will politely disagree with you, by pointing out the the question was answered perfectly, in that no one, including you, has ever been able to produce a copy of ANY law that you (without expertise or proof, based on nothing more than hearsay) apparently still claim would allegedly make it "illegal" for a patient to change his or her own pressure.

Read full answer, now that I've had time to post more complete information.

I wonder, though: Are you suggesting that the doctors who allow patients to change pressures for themselves are all complicit criminals? I believe that the doctors who read this board might be interested on your basis for that, if that is your belief.

Practitioners with appropriate licensing to direct PAP therapy are provisioned for in the FDA's document. If they say you can use '5 to 20cm H20' or 'whatever pressure works' then that is within the scope of their license to direct.

My understanding (similarly without expertise or proof, based on nothing more than hearsay) is that the laws of informed consent make it just as illegal for any medical person to force a particular pressure down my throat as it would be for them to tie me down and force a particular dose of a pill down my throat, except in certain highly exceptional circumstances, if we are going to stoop to the drug analogy outright.

Or is it your claim that my agreeing to PAP therapy somehow implies my forfeiting my right to bodily integrity?

Red herring and unrelated to topic in discussion. It is a very important part of healthcare for all of us to retain choice in our healthcare. This is why our legal system provides for refusal of medical care in most situations.

I choose to work with doctors who allow me some say in my treatments. PAP is no exception. If a doctor isn't good with that, I would choose a different doctor. Neither my sleep doctor nor my primary care physician has any trouble with my adjusting my own pressure. In fact, my primary care physician encourages it. Is it your position that I am obligated to turn them in to the authorities for their radical (and as implied by you, criminal) departure from accepted medical practice?

See above, they're within scope as practitioners to instruct you as they believe will suit your health.

Oh well, I guess that's what I'll have to do--write the authorities about my doctors' position on this matter to turn them both in. To whom exactly would you recommend that I address that letter to, if there is someone you think would get a good chuckle from it?

The hostility of your post is unproductive for active discourse that will result in improved care and understanding for patients and practitioners alike.

@JNK (post at 11:07)
Technicians/technologists change pressures during titrations under the license of the Medical Director who signs off on the P&P Manual. Also, many states have enacted or in process of enacting Licensing laws for Technologists/technicians. See SB 132 in CA for an example.

@Tony

It's true that my prior post didn't cite anything. I had sufficient time this morning to re-visit the topic and hopefully provide more concrete information.

I agree that the legal issues and (lack of) case law surrounding patients changing pressures/variables outside of physician instruction are VERY vague. I spent an hour trying to track down specifics because the topic intrigued me as a healthcare practitioner. I've run out of time though for tracking down the rest of the legality. I'm also in healthcare and not law, so it's murky territory.

There was no intention of my post having a tone of condescension. If it came across as such then you have my apology.

Lastly, the issue of deciding to adjust pressure or not goes far beyond the issue of legality. The legal portion is just the tip of the iceberg and I'm sure most users of PAP would agree. If I were a current user of CPAP (will probably qualify for PAP and use it in the future myself), legal issues would be just a part of the equation. Determining my level of perceived benefit, continued excessive daytime somnolence, perception of the competence of my healthcare providers in accurately assessing my pressure/variables, administrative/practical hurdles to care/re-assessment would all play a role in my own decision for how to proceed on changing or not-changing settings. I'd be just as irritated with having to jump through hoops for care as I am with other prescription medications. It's incredibly irritating.

@HoseCrusher

I hire a medical team to help me with my health. I listen carefully to their advice and recommendations, but in the end it is my health and I live or die by my decisions.

Absolutely right. Every chance I get, I remind my patients that they will be their own best advocate (no matter how good their healthcare team is). It's vital that patients take an active role in their own care.

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Last portion
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Hi to the CPAPTalk community!
I'm here after being a healthcare provider in Sleep Medicine for 5 yrs. I came by this board because of the positive feedback from a close friend who (stubbornly without my help or counsel) went through a grueling year of trying to get help for his Complex Sleep Apnea. He sent a multipage letter ranting (justified, for the record) about the lack of adequate care and clinical knowledge of his own Sleep Medicine providers (physicians, techs and DME... esp. DME). His solace in this process was the support and information he garnered here on CPAPTalk.

So, I wanted to come by and see for myself.

All the best,
Polysomning

At some point, I can see where the technology will be so intuitive that prescriptions should only be needed for insurance coverage.
--like glucose meters.
(or insurance will simply not cover it)

chunkyfrog wrote:At some point, I can see where the technology will be so intuitive that prescriptions should only be needed for insurance coverage.
--like glucose meters.
(or insurance will simply not cover it)

And we'll have much better success at therapies... it'll be a good day for all involved.

You will be a welcome addition to our forum, Polysoming!