State law in Ct.

[jnk]

Disclaimer again: I'm in healthcare, not a lawyer.

And yet you continue to contradict the lawyers who post here. Interesting. But your right.

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

These were posts about the need for an Rx to buy a machine, if I read them correctly. Did you have a particular statement in mind?

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

And what part of that prohibits patients from, for example, raising their own minimum for comfort and effectiveness, using the APAP they own but that the doc and DME set to 4-20 cwp?

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."

Actually, the point is, IMO, that it does NOT so follow, and it is NOT logical to so construe the facts, since I don't need a medical license to use the machine my doctor prescribed.

Do I know any patients that have ever faced legal consequences from changing their PAP pressure(s), no.

Then I thank you for adding that much productively to the discussion at hand, which will benefit patients and doctors alike.

Does this fact change the legal position of the FDA on "directing device use without an appropriate license", no.

Red herring, since I don't need a medical license to use my machine.

now that I've had time to post more complete information.

Where?

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.

Maybe we are discussing different topics. I thought the discussion was my right to change my pressures, which is about informed consent and bodily integrity. I have a right to refuse PAP treatment completely. Thus, it follows that I have the right to refuse 10 cm and accept 9 cm, if I so choose. I might be unwise to do so, but I would not be breaking a law. And that is the topic I'm discussing in the thread I'm reading.

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.

Note below the basis for my hostility, highlighted in red in one of your statements, not hostility directed at you personally.

@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.

Yes, they need that permission, since it is not their own machine being used to treat themselves.

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.

Then why are you posting statements implying that it is all crystal clear? Which is it?

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

I personally don't doubt your motives. As mstevens wrote so well:

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

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.

And now you know the reason for my hostility. His situation is FAR from rare, IMO. People not getting the help they need from professionals have to have the legal right to take matters into their own hands in order to save their own lives. Would you not agree? Or should we just be subservient and roll over and let the ignorant RTs quoting non-laws have their way with us?

I have no hostility against you personally. I don't know you. You sound like a very good person, good at what you do. I apologize for sounding hostile to you. My hostility is very real, though. It is against the lies RTs at DMEs tell patients in an attempt to actively prevent the patient from getting good therapy. Lies such as "it is against the law for you to change your own pressures." One lie of many in my experience and the experience of many posts I've read on this board.

I remain hostile to the statement until I see proof that it isn't a lie meant to scare patients from getting good therapy for their own bodies using a machine that belongs to them--especially when most sleep docs just want the patient to get good sleep, regardless of whose fingerprints are found on the dial.

It may sound hollow now, but I sincerely welcome you to the board, and I will do my best to be more polite when attacking views I don't agree with. It is a constant battle for me. I appreciate your personal patience in that regard.

[LinkC]

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."

That is part of a definition, not a statement of "legality". And it merely says "is not safe" with NO legal ramifications at all. Methinks you are grasping at straws... Like you, I USED to think it was illegal for an individual to change the dosage of a prescribed treatment. An exhaustive search of FDA regs turned up nothing. I even paid an "ask a lawyer" site to determine if it was illegal. Their response was "no" at the federal level, or the State of Florida (where I reside). Other states may vary, they warned.

However, I wonder about the repercussions of those on this forum who interpret data and "direct the use" in terms of pressure changes. No, we aren't physically changing the settings. Neither are most doctors, but they do tell others what settings to use. Which is often done here.

[So Well]

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.

-Polysomning

I think you made that up just to support your argument. Can you cite the regulation?

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.

You have a point (but if you wear a hat no one will notice).

What about split night studies? Do the techs have authority to stop the study and convert to a titration study? Or do they have to call the doctor out of bed and ask for a prescription?

[LinkC]

I think you made that up just to support your argument. Can you cite the regulation?

I think so as well. I've found NO Federal or State of Florida regulation that prohibits the patient from deviating from the prescribed dosage.

[GumbyCT]

This is like deja vu all over again.

ps. It should be noted, that in this case, the people the OP talked to on the phone are NOT RT's, nor doctors or nurses. They are NOT trained in OSA much less licensed by the state to provide advise.

pps. We ass-u-me when we call our DME that the people who answer the phone have some training in what we are calling about but I can assure you that is not the case.

[jnk]

I have a confession to make: Ever since this post . . .

LIES, LIES, and more LIES.

This song goes through my head every time I return to this thread:

http://www.youtube.com/watch?v=-x3TMBeX-ws

It is my understanding that the song is about crazy DMEs and the handcuff-donning pressure police, but there also seems to be a hidden-undercurrent message about RLS/PLMs. Either way, I'm pretty sure that the six-legged guy would be wearing a CPAP if the camera pulled back farther.

[Vader]

I have a confession to make: Ever since this post . . .

LIES, LIES, and more LIES.

This song goes through my head every time I return to this thread:

http://www.youtube.com/watch?v=-x3TMBeX-ws

It is my understanding that the song is about crazy DMEs and the handcuff-donning pressure police, but there also seems to be a hidden-undercurrent message about RLS/PLMs. Either way, I'm pretty sure that the six-legged guy would be wearing a CPAP if the camera pulled back farther.

I'm showing my age here, but I couldn't help but think of The Knickerbockers "Lies"
https://www.youtube.com/watch?v=1n03a7cLf0M

[jnk]

I'm showing my age here, but I couldn't help but think of The Knickerbockers "Lies"
https://www.youtube.com/watch?v=1n03a7cLf0M

Thanks, Vader. That gives me a better song to have in my head.

I was a one-year-old brat at the time, so I don't remember the song, but good stuff! They out-beatled the Beatles, sounds like.

Like they say, Impersonation is the sincerest form of lie. Or something like that.

Kinda the way the modern Knicks pretended like they wanted to get anywhere in the playoffs this year.

(For any pros wandering in, this post is a form of forum banter meant to raise threads to the top. So don't let it throw you. We are all (mostly) serious about CPAP around here, even those of us who look like a big green cartoon character or one of the dark lords of the Sith. )

[mstevens]

When it comes to FDA, keep in mind that they really don't get involved in how people USE things. They don't care if I prescribe off-label. They don't care if you sell your OxyContin to your neighbor (The DEA sure as heck does, but not the FDA). They don't care who, if anyone, messes with your CPAP pressure. They do care what marketing claims are made for drugs or devices and they do care about the product labeling (which has much to do with the marketing claims), production processes, and evidence for safety and efficacy.

So, FDA cares if someone sells you a CPAP machine without a prescription (but not if you buy one without) but they don't care what the prescription says or even if you, after you get the machine, follow the prescription or not.

In terms of techs doing titrations or split-night studies, they already have all the applicable orders before anything gets started. Doctors are very good at writing orders that minimize the need for anyone to wake them up. The techs aren't doing anything without an order.

[jnk]

but if you wear a hat no one will notice.

I do. But they still do.

Doctors are very good at writing orders that minimize the need for anyone to wake them up.

And techs that are good at not getting fired understand that very well, I bet.

[mstevens]

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.

Not really. Surprisingly enough, you're under no legal obligation to follow a prescription (except for certain situations involving active-duty military or court orders). Pharmacists are but patients aren't. It may be illegal to obtain certain prescriptions under certain circumstances, but the laws concerning prescription drugs overwhelmingly pertain to the people writing and filling the prescriptions, not the end-users. As long as you have a legally-obtained prescription, you're not likely to be successfully prosecuted for using it unless this results in some other problem (such as driving under the influence of a controlled substance).

[rested gal]

What about split night studies? Do the techs have authority to stop the study and convert to a titration study? Or do they have to call the doctor out of bed and ask for a prescription?

As I understand it (and I ain't a sleep tech or anything in the medical field!) I'd think the conditions under which a baseline study could include a split to titration would (or should) be covered by the P&P (Practices and Protocols ?) manual of the lab, and/or what the referring doctor ordered.

As Polysomning pointed out, the P&P manual has already been signed off on by the Medical Director (an M.D., I suppose) of the lab.

From what I've read, labs which do perform split night studies have requirements that must be met before the patient qualifies for "splitting" the study from baseline to CPAP/bilevel titration. I think both Medicare and the AASM (American Academy of Sleep Medicine) outline specific requirements to qualify for "split night study."

So, imho,no...the sleep tech would not have to call a doctor a couple of hours into a sleep study to get permission, or a physician's order, to start applying CPAP to perform a split night study if the lab's protocol allows for "split night" studies at all (I'd guess most do allow for that.)

btw, Polysomning, you've made it onto my "good'uns" list...for whatever that's worth.
viewtopic.php?p=442957#p442957

[jnk]

It is 2011, so I guess the people involved in this study should be getting out of jail any day now . . .

http://ajrccm.atsjournals.org/cgi/conte ... /167/5/716

[rested gal]

It is 2011, so I guess the people involved in this study should be getting out of jail any day now . . .

http://ajrccm.atsjournals.org/cgi/conte ... /167/5/716

One of my favorite links, as you know, Jeff.

Presumably there was at least one doctor involved in that research study who had given permission to allow the people to push them-thar pressure settings buttons themselves.

[Janknitz]

btw, Polysomning, you've made it onto my "good'uns" list...for whatever that's worth.

Ditto, Poly, I hope this thread doesn't scare you away or make you go away mad, as many "professionals" before you have done.

This group vehemently advocates for empowering the CPAP user in all aspects of treatment, and--it works (isn't that why you said you're here in the first place?). Everyone responding is a successful and compliant CPAP user because they took the time to learn about their own treatment and take an active role in their own care. Many have had some lousy experiences with the so-called "professionals"--but we are not talking about professionals like you who seem to understand the power of the collaborative role the CPAP user can (and should) play in getting optimal treatment. If some people here take their treatment into their own hands, it's because they cannot get the professionals to collaborate in a way to ensure that the treatment is most effective.

That's why this healthy debate happens regularly, and why it is so emotional--acting like sheep and accepting whatever we were told does NOT guarantee good care!