Are Clinician Manuals Illegal

Hose_Head wrote:

RN Ricky wrote:

If my interpretation is correct for your state, you may wish to remind the RT that the Rx must be filled as written by the MD.

You also might ask the RT for the precise reference for the law that was quoted re the clinician manual. Others in this forum have asked this same question, numerous times. I am unaware of anyone being able to find such a law. I'm of the conclusion that it's a law that's written by the DME and/or the manufacturer of the product (i.e. it's not a law at all, it's a corporate policy, perhaps based on a contractual arrangement between the two)

Sadly bureaucracy often trumps a prescription. Providers are not required to fill a prescription at all and are within their rights to not fill a perfectly legal prescription that runs amiss of their rules. The most common cause is an insurance company but where DME is involved its often a matter of policy or contract.

That why I chose an Auto CPAP over a standard CPAP. From what I've read this is not the best solution for everyone but an Auto CPAP set to its full range can avoid the need for many adjustments or follow up sleep studies as long as the therapy remains effective.

JohnBFisher wrote:

Hose_Head wrote:... I am unaware of anyone being able to find such a law. I'm of the conclusion that it's a law that's written by the DME and/or the manufacturer of the product (i.e. it's not a law at all, it's a corporate policy, perhaps based on a contractual arrangement between the two) ...

That is what is known as a contract. To the best of my knowledge a prescription can not trump a legally binding contract. If they could then a doctor could write a prescription to allow me to see company proprietary information about the device that I use for my therapy. I doubt it would not stand up in a court. While the device should be provided as written, the contract between the DME and the manufacturer probably requires removal of the manual. The device can be prescribed. But the prescription can not circumvent the contractural obligations between the parties. In that case, neither the doctor nor the patient has any standing to challenge the contract or those obligations. Unless you can prove that it would harm either party ... and in fact the evidence is that improper use could cause harm.

At least that's the way I read the situation. I may be mistaken. Trust me, it happens all the time. Hope it makes sense.

I'm in agreement with you. But it sounds like you're guessing, too. It also raises the question, if it's a contractual requirement between DME and manufacturer, or a DME corporate policy that the clinician manual not be provided to the patient, then why can't the RT say so rather than mislead the patient by saying it's illegal to do so? That kind of misdirection only leads to mistrust on the part of the patient.

RN Ricky wrote:A quick question for the Forum Folk! Does anyone know for a fact that it is illegal in Florida for a person who uses a CPAP to have a clinician manual? Or does the FDA control that on a national leval? Just received a new machine & the RT told me that. Guess where I got that info?? The Big "A". My MD actually wrote a script for a specific unit AND a clinician manual. I suppose that the MD doesn't know me well enough to let me have a manual

Also the other "RT" didn't quite know how to place a cover from the unit into the humidifier so that it would not get lost. Then she tightened the mask headgear so tight that I had to tell her -- her response -- fix it when you get home. No wonder new cpapers quit!

Another question-- if the pressure is adjusted too high will it damage the lungs or just explode them?

When I got my CPAP here in Montana, the R.T. stated that I could have the clinician manual as well since I worked in a sleep lab and understood how things worked. So If it was illegal I'm assuming I would have to be more than a sleep tech. to qualify and have the clinician manual. I think allot depends on the DME feeling comfortable with the patient to be honest. But I can only speak of my experience with my DME.

Also one person stated and I agree, too much pressure can cause induced central apneas, as well as increase your arousals and wake you up more. Now I 'm bias on some subjects due to my nature of work, but I don't think some fine tuning of pressures hurts anyone. I turned my machine up two pressures since I've had it. No doctor order, no titration study. Based on the fact that I was still snoring through my mask. Someone once told me that changing your pressure on the CPAP without the doctor was like a person changing all their prescription drugs on their own. We'll I don't agree with that. Small pressure changes won't hurt anyone. If you feel better after the pressure change, you know you did the right thing!

"Illegal" can be a slippery concept. My question is, what punishment has been mandated for documented violations?

I mean, hey, it's illegal to drive one mph over the speed limit for one second, right? But if I showed up at the local precinct to turn myself in for that, I seriously doubt I would be issued a ticket. All it would likely get me is another ride to visit some more with those very nice men in white suits.

Thanks to all of you who replied. I have downloaded a copy. My main goal was not to change the pressure setting but to monitor leaks, AHI, etc.
Thanks again

RN Ricky wrote:Thanks to all of you who replied. I have downloaded a copy. My main goal was not to change the pressure setting but to monitor leaks, AHI, etc.
Thanks again

And I thought it was "Pure Entertainment"....lmao....here come the PapCops and they don't look happy....lmao.

I can't trust anyone who would make up things like that. Esp. when it comes to my healthcare.

How can you tell when your DME is lying?




Answer: You can see his lips move!

My DME brought my new Respironics Bipap Auto M machine to me and also the user manual and provider manual. He said he didn't normally give the provider manual to the patient but since I knew a lot about them anyway he was giving it to me. I told him I do swap between the Auto setting and my Rx setting. In Auto mode, the Bipap starts at a lower Ipap pressure than my Rx. Hence if I have trouble at anytime with the lower pressure, I just go back to my Bipap settings. To enter provider settings everyone mostly knows anyway you plug the machine in while holding down 2 buttons.

sthnreb wrote:. To enter provider settings everyone mostly knows anyway you plug the machine in while holding down 2 buttons.

Exactly - which is why I don't buy the excuse they use for the software.

They don't want us to have Encore Pro bc you can change the pressure with it. But you do NOT need software to change the pressure. All just BS.

It is not illegal for you to have a clinician manual. It is however a touchy situation as it pertains to providers giving you one. To be perfectly honest its not clear if its illegal. It is however clear that the maker of the equipment does not want you to have the manual. When they state in there manual not to give the manual to the patient, they are in effect attempting to shift the liability to the provider. Most providers will not accept that liability and will not give out the manual. Most accredidation services require that providers follow manufacturers reccomendations. In short your provider is between a rock and a hard place, its not right, but its the way it is...

Hose_Head wrote: why can't the RT say so rather than mislead the patient by saying it's illegal to do so? That kind of misdirection only leads to mistrust on the part of the patient.

The RT only knows what his employer has told him/her...plus what's printed on the manual. That's enough for it to be "illegal" from his standpoint. It also deters the patient from further discussion of the manual.

As to "mistrust", if you are counting on an RT for accurate legal advice, your trust is already misplaced, IMHO.

@John: I agree with your assessment that a contract trumps a prescription.

The manuals are widely available, even on E-Bay. I've not seen that much in one. It tells how to enter the provider mode and then has a chart of each advanced screen and the different setting you can use. They are really self explanatory. The only real advantage is to change the pressure or turn biflex on or off plus the ramp. Adjustments to these are in the user mode settings. The software does allow you to change settings with the card but it can also be done manually at the machine.

As to LinkC's comments about mistrust as it pertains to RT's, your painting with a very wide brush. As a matter of fact I find it offensive that you would say that an RT can't be trusted. As to your first point concerning that the RT only knows what his employer tells him, on this point too you obviously don't know how DME's are ran nor are you aware of each specific states licensure requirements for RT's. Its usually the RT withing the DME that knows the "rules" and statutes concerning permissive acts. Since its the RT's responsibility to ensure he's acting within the permissable guidelines of his states licensure laws it does not matter what his employer says about the situation, the employer can not trump state law. I know its fashionable to beat up on RT's and DMEs but please consider that some of us try to do it right...

rjjayrt wrote:As to LinkC's comments about mistrust as it pertains to RT's, your painting with a very wide brush. As a matter of fact I find it offensive that you would say that an RT can't be trusted. As to your first point concerning that the RT only knows what his employer tells him, on this point too you obviously don't know how DME's are ran nor are you aware of each specific states licensure requirements for RT's. Its usually the RT withing the DME that knows the "rules" and statutes concerning permissive acts. Since its the RT's responsibility to ensure he's acting within the permissable guidelines of his states licensure laws it does not matter what his employer says about the situation, the employer can not trump state law. I know its fashionable to beat up on RT's and DMEs but please consider that some of us try to do it right...

I believe that LinkC's point, if I understood it, was that taking legal advice from any medical professional would be like asking the plumber to fix your electrical problem. I guess my brush is even wider than his!

I was unaware that RT training involved specific instructions about the legalities of who gets what manual. How many hours are dedicated to that? I guess we'll all have to take your word for it.

There are some great RTs who post on this board.

I, too, wish there were more posts about helpful RTs here. Perhaps someone should start a thread, or make a poll, for posting stories of RTs who have been particularly helpful to patients at local DMEs. The problem with that, I think, is that if a patient is getting good help at the local DME, they are less likely than the rest of us to go searching for help on the Internet and end up here.

rjjayrt wrote:As to LinkC's comments about mistrust as it pertains to RT's, your painting with a very wide brush. As a matter of fact I find it offensive that you would say that an RT can't be trusted. As to your first point concerning that the RT only knows what his employer tells him, on this point too you obviously don't know how DME's are ran nor are you aware of each specific states licensure requirements for RT's. Its usually the RT withing the DME that knows the "rules" and statutes concerning permissive acts. Since its the RT's responsibility to ensure he's acting within the permissable guidelines of his states licensure laws it does not matter what his employer says about the situation, the employer can not trump state law. I know its fashionable to beat up on RT's and DMEs but please consider that some of us try to do it right...

The bottom line is usually that no one wants to find themselves unemployed and given it is the DME paying the salary and not the patient I suspect many RT's will fall into line with the DME policies.

rjjayrt wrote: As a matter of fact I find it offensive that you would say that an RT can't be trusted.

Soooo, the next time I have a legal, financial, religious or grammar issue I should seek advice from an RT as they are experts in ALL areas? I wouldn't trust advice from a priest concerning a respiratory concern, either. That's all I'm sayin'...

rjjayrt wrote: it does not matter what his employer says about the situation, the employer can not trump state law.

Sure he can! He can certainly impose restrictions which are more stringent than ANY law. And he most likely WILL if he has a contract with ResMed requiring him to do so.

rjjayrt wrote: To be perfectly honest its not clear if its illegal.

Either there's a law against it or there's not. Perhaps it's not clear to YOU. And it isn't to me, either. But neither of us are lawyers...
That's why I wouldn't trust EITHER of us on that.